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BACKGROUND Necrotizing enterocolitis ( NEC ) and nosocomial sepsis are associated with increased morbidity and mortality in preterm infants . Through prevention of bacterial migration across the mucosa , competitive exclusion of pathogenic bacteria , and enhancing the immune responses of the host , prophylactic enteral probiotics ( live microbial supplements ) may play a role in reducing NEC and the associated morbidity . OBJECTIVES To compare the efficacy and safety of prophylactic enteral probiotics administration versus placebo or no treatment in the prevention of severe NEC or sepsis , or both , in preterm infants . SEARCH METHODS For this up date , search es were made of MEDLINE ( 1966 to October 2013 ) , EMBASE ( 1980 to October 2013 ) , the Cochrane Central Register of Controlled Trials ( CENTRAL ) in The Cochrane Library ( 2013 , Issue 10 ) , and abstract s of annual meetings of the Society for Pediatric Research ( 1995 to 2013 ) . SELECTION CRITERIA Only r and omized or quasi-r and omized controlled trials that enrolled preterm infants , were considered . Trials were included if they involved enteral administration of any live microbial supplement ( probiotics ) and measured at least one prespecified clinical outcome . DATA COLLECTION AND ANALYSIS St and ard methods of The Cochrane Collaboration and its Neonatal Group were used to assess the method ologic quality of the trials and for data collection and analysis . MAIN RESULTS Twenty-four eligible trials were included . Included trials were highly variable with regard to enrolment criteria ( that is birth weight and gestational age ) , baseline risk of NEC in the control groups , timing , dose , formulation of the probiotics , and feeding regimens . In a meta- analysis of trial data , enteral probiotics supplementation significantly reduced the incidence of severe NEC ( stage II or more ) ( typical relative risk ( RR ) 0.43 , 95 % confidence interval ( CI ) 0.33 to 0.56 ; 20 studies , 5529 infants ) and mortality ( typical RR 0.65 , 95 % CI 0.52 to 0.81 ; 17 studies , 5112 infants ) . There was no evidence of significant reduction of nosocomial sepsis ( typical RR 0.91 , 95 % CI 0.80 to 1.03 ; 19 studies , 5338 infants ) . The included trials reported no systemic infection with the supplemental probiotics organism . Probiotics preparations containing either lactobacillus alone or in combination with bifidobacterium were found to be effective . AUTHORS ' CONCLUSIONS Enteral supplementation of probiotics prevents severe NEC and all cause mortality in preterm infants . Our up date d review of available evidence strongly supports a change in practice . Head to head comparative studies are required to assess the most effective preparations , timing , and length of therapy to be utilized | [
"UNLABELLED The aim of the study is to compare the role of killed ( KP ) Lactobacillus acidophilus with living ( LP ) in reducing incidence of sepsis ( NS ) and necrotizing enterocolitis ( NEC ) in neonates . R and omized double blind placebo study , included 150 neonates admitted to NICU at day 1 , sixty received oral ( LP ) and 60 received ( KP ) and 30 received placebo . One gram of stools was collected on admission , at day 7 , at end of the study , as well as on suspected NEC or NS and was sent for culture . RESULTS LP and KP were preventive factors for NEC with absolute risk reduction ( AAR ) 16 , 15 % , respectively and 18 % for NS compared to placebo . Incidence of NEC and NS did not differ significantly between neonates supplemented with LP and those with KP . Preterm neonates supplemented with KP showed significantly lower incidence of NEC compared to placebo , while incidence of NS showed no significant difference between both groups . There is significant reduction in NS and NEC among neonates with positive Lactobacillus colonization of gut compared to those none colonized at day 7 ( 27.9 vs. 85.9 % , 0 vs. 7.8 % ) and at day 14 ( 48.7 vs. 91.7 % for NS and 0 vs. 20.8 % for NEC ) . Overall comparison between the three groups showed statistical significant reduction in the incidence of NEC . Present conclusions are that early gut colonization with beneficial bacteria lowers the incidence of NEC and NS . KP retained similar benefits to live bacteria",
"BACKGROUND Probiotics are used for the prevention of necrotizing enterocolitis ( NEC ) because of their positive effects on intestinal motor function , modulation of inflammatory response , and mucosal barrier function . OBJECTIVE The objective was to assess whether the combined use of Lactobacillus casei and Bifidobacterium breve may prevent the occurrence of NEC stage ≥ 2 by the criteria of Bell in very-low-birth-weight preterm infants . DESIGN A double-blind , r and omized , controlled clinical trial was conducted in 231 preterm infants weighing from 750 to 1499 g at birth . The intervention group was composed of 119 infants who received human milk with probiotic supplementation ( B. breve and L. casei ) and a control group of 112 infants who received human milk containing no probiotics . The primary outcome was the occurrence of NEC stage ≥ 2 as defined by Bell 's modified criteria . RESULTS Four confirmed cases of NEC stage ≥ 2 by Bell 's criteria occurred only in the control group . CONCLUSIONS Oral supplementation of B. breve and L. casei reduced the occurrence of NEC ( Bell 's stage ≥ 2 ) . It was considered that an improvement in intestinal motility might have contributed to this result . This trial was registered at www.is rct in.org as number 67165178 ( International St and ard R and omized Controlled Trial )",
"ABSTRACT The gastrointestinal microbiota of preterm infants in a neonatal intensive care unit differs from that of term infants . In particular , the colonization of preterm infants by bifidobacteria is delayed . A double-blind , placebo-controlled , r and omized clinical study was performed on 69 preterm infants to investigate the role of Bifidobacterium lactis Bb12 supplementation in modifying the gut microbiota . Both culture-dependent and culture-independent approaches were used to study the gut microbiota . Bifidobacterial numbers , determined by fluorescence in situ hybridization , were significantly higher in the probiotic than in the placebo group ( log10 values per g of fecal wet weight : probiotic , 8.18 + 0.54 [ st and ard error of the mean ] ; placebo , 4.82 + 0.51 ; P bifidobacterial numbers was also obtained with the culture-dependent method . The infants supplemented with Bb12 also had lower viable counts of Enterobacteriaceae ( log10 values of CFU per g of fecal wet weight : probiotic , 7.80 + 0.34 ; placebo , 9.03 + 0.35 ; P = 0.015 ) and Clostridium spp . ( probiotic , 4.89 + 0.30 ; placebo , 5.99 + 0.32 ; P = 0.014 ) than the infants in the placebo group . Supplementation of B. lactis Bb12 did not reduce the colonization by antibiotic-resistant organisms in the study population . However , the probiotic supplementation increased the cell counts of bifidobacteria and reduced the cell counts of enterobacteria and clostridia",
"BACKGROUND It is known that the bifidobacteria flora play important roles in mucosal host defense and can prevent infectious diseases . Because bacterial population s develop during the first day of life , the authors examined whether the early administration of bifidobacteria has a positive effect on the health of low birth weight infants . METHODS The effects of oral administration of Bifidobacterium breve ( B. breve ) supplements were studied in a controlled trial with low birth weight infants ( average birth weight 1489 g ) . The infants were divided into three groups : Group A and B received a dose of 1.6 x 10(8 ) cells of B. breve supplement twice a day , commencing either from several hours after birth ( group A ) or 24 h after birth ( group B ) . Group C , the control group , received no supplement . RESULTS There were no significant differences in birth weight , treatment with antibiotics , and the starting time of breast-feeding among the three groups . A Bifidobacterium-predominant flora was formed at an average of 2 weeks after birth in group A and at an average of 4 weeks after birth in group B , while no Bifidobacterium was isolated in eight out of 10 infants in group C during the observation period of 7 weeks . In comparison between group A and B , Bifidobacterium was detected significantly earlier in group A , and the number of Enterobacteriaceae present in the infants at 2 weeks after birth was significantly lower in group A. CONCLUSION The results of the present study suggest that very early administration of B. breve to low birth weight infants is useful in promoting the colonization of the Bifidobacterium and the formation of a normal intestinal flora",
"Objective : To evaluate the efficacy of probiotics in the prevention of gastrointestinal colonization by C and ida species , of late-onset sepsis and neurological outcome in preterm newborns . Study Design : A prospect i ve study was conducted in 249 preterms who were subdivided into three groups : one group ( n=83 ) was supplemented with Lactobacillus ( L. ) reuteri , one group with L. rhamnosus ( n=83 ) and the other with no supplementation ( n=83 ) . The fungal colonization in the gastrointestinal tract , the late onset of sepsis and clinical parameters were recorded . A neurological structured assessment was further performed at 1 year of age . Result : C and ida stool colonization was significantly higher ( P L. reuteri group presented a significantly higher reduction in gastrointestinal symptoms than did the L. rhamnosus and control groups . Infants treated with probiotics showed a statistically significant lower incidence of abnormal neurological outcome than did the control group . Conclusion : The use of both probiotics seems to be effective in the prevention of gastrointestinal colonization by C and ida , in the protection from late-onset sepis and in reducing abnormal neurological outcomes in preterms",
"BACKGROUND AND OBJECTIVE : It has been suggested that probiotics may decrease infant mortality and nosocomial infections because of their ability to suppress colonization and translocation of bacterial pathogens in the gastrointestinal tract . We design ed a large double-blinded placebo-controlled trial using Lactobacillus reuteri to test this hypothesis in preterm infants . METHODS : Eligible infants were r and omly assigned during the first 48 hours of life to either daily probiotic administration or placebo . Infants in the intervention group were administered enterally 5 drops of a probiotic preparation containing 108 colony-forming units of L reuteri DSM 17938 until death or discharge from the NICU . RESULTS : A total of 750 infants ≤2000 g were enrolled . The frequency of the primary outcome , death , or nosocomial infection , was similar in the probiotic and placebo groups ( relative risk 0.87 ; 95 % confidence interval : 0.63–1.19 ; P = .376 ) . There was a trend toward a lower rate of nosocomial pneumonia in the probiotic group ( 2.4 % vs 5.0 % ; P = .06 ) and a nonsignificant 40 % decrease in necrotizing enterocolitis ( 2.4 % vs 4.0 % ; P = .23 ) . Episodes of feeding intolerance and duration of hospitalization were lower in infants ≤ 1500 g ( 9.6 % vs 16.8 % [ P = .04 ] ; 32.5 days vs 37 days [ P = .03 ] ) . CONCLUSIONS : Although L reuteri did not appear to decrease the rate of the composite outcome , the trends suggest a protective role consistent with what has been observed in the literature . Feeding intolerance and duration of hospitalization were decreased in premature infants ≤1500",
"Background : Nosocomial infections endanger preterm infants . Objective : The aim of the present controlled r and omized trial was to investigate whether Bifidobacterium lactis reduces the incidence of nosocomial infections in infants with very low birth weight ( VLBW ; Patients and Methods : In a r and omized controlled trial , 183 VLBW infants were stratified according to gestational age ( 23–26 and 27–29 weeks ) and early antibiotic therapy ( days 1–3 , yes or no ) and r and omly assigned to have their milk feedings supplemented with B. lactis ( 6 × 2.0 × 109 CFU/kg/day , 12 billion CFU/kg/day ) or placebo for the first 6 weeks of life . Primary outcome was the ‘ incidence density ’ of nosocomial infections defined as periods of elevated C-reactive protein ( > 10 mg/l ) from day 7 after initiation of milk feedings until the 42nd day of life ( number of nosocomial infections/total number of patient days ) . The main secondary outcome was necrotizing enterocolitis ( NEC ; ≧stage 2 ) . Results : There were 93 infants in the B. lactis group and 90 in the placebo group . There was no significant difference between the two groups with regard to the incidence density of nosocomial infections ( 0.021 vs. 0.016 ; p = 0.9 , χ2 test ) . There were 2 cases of NEC in the B. lactis group and 4 in the placebo group . None of the blood cultures grew B. lactis . Conclusion : In the present setting , B. lactis at a dosage of 6 × 2.0 × 109 CFU/kg/day ( 12 billion CFU/kg/day ) did not reduce the incidence density of nosocomial infections in VLBW infants . No adverse effect of B. lactis was observed",
"Background A r and omised , double-blind clinical trial was undertaken in order to assess the effectiveness of probiotics in the prevention of necrotising enterocolitis ( NEC ) in newborns weighing Methods We studied a group of 150 patients who were r and omised in two groups after parental consent was obtained , to receive either a daily feeding supplementation with a multispecies probiotic ( Lactobacillus acidophilus , Lactobacillus rhamnosus , Lactobacillus casei , Lactobacillus plantarum , Bifidobacteruim infantis , Streptococcus thermophillus ) 1 g per day plus their regular feedings or to receive their regular feedings with nothing added ( control group ) , over the period of January 2007 through June 2010 . Clinicians in care of the infants were blinded to the group assignment . Results The primary outcome was the development of NEC . Both groups were comparable , with no differences during hospitalisation , including the type of nutrition received . Blood cultures obtained from cases that developed sepsis did not reveal lactobacillus or Bifidobacteria growth . No differences were detected in terms of NEC risk reduction ( RR : 0.54 , 95 % CI 0.21 to 1.39 ) although we did observe a clear trend in the reduction of NEC frequency in the studied cases : 6 ( 8 % ) versus 12 ( 16 % ) in the control group . When the combined risk of NEC or death was calculated as a post hoc analysis , we found a significantly lower risk ( RR : 0.39 , 95 % CI 0.17 to 0.87 ) for the study group . Conclusions Probiotics may offer potential benefits for premature infants and are a promising strategy in the reduction of the risk of NEC in preterm newborns",
"BACKGROUND Saccharomyces boulardii ( SB ) is a yeast that acts both as a probiotic and as a polyamine producer . Probiotics prevent the overgrowth of pathogens in the gut while polyamines enhance intestinal maturation . The aim of this r and omized study was to investigate the ability of SB to modify the gut microbial ecology and its function . METHODS A total of 87 healthy babies with gestational age 28 - 32 weeks were studied . They were r and omly assigned to receive a preterm formula to which SB or maltodextrins was added for 30 days . Evaluations were made on the following : SB tolerance and weight gain , faecal flora analysis , intestinal D-xylose absorption and faecal lipid excretion . RESULTS SB was well tolerated by the infants . There was no difference in weight gain between the two groups . Median log of colony forming units per gram of faeces for Escherichia coli and enterococci was significantly lower in the SB group [ E. coli : 2.67 ( 0.045 ) vs. 2.75 ( 0.058 ) , P number of bifidobacteria and staphylococci in the stools was significantly higher in the SB group [ bifidobacteria : 2.65 ( 0.083 ) vs. 2.27 ( 0.075 ) , P D-Xylose and lipid absorption was not improved by SB [ median blood D-xylose : 1.5 ( 0.4 ) mmol/l vs. 1.35 ( 0.3 ) mmol/l , P>0.1 ; median stool steatocrit : 64 % ( 3.05 % ) vs. 65 % ( 2.72 % ) P>0.5 ] . CONCLUSIONS An SB-supplemented formula is well tolerated by preterm infants , it has a beneficial effect on stool flora bringing it closer to that of breast fed babies but it does not improve D-xylose or lipid gut absorption",
"CONTEXT Sepsis is a common and severe complication in premature neonates , particularly those with very low birth weight ( VLBW ) ( Whether lactoferrin , a mammalian milk glycoprotein involved in innate immune host defenses , can reduce the incidence of sepsis is unknown . In animal models , the probiotic Lactobacillus rhamnosus GG ( LGG ) enhances the activity of lactoferrin but has not been studied in human infants . OBJECTIVE To establish whether bovine lactoferrin ( BLF ) , alone or in combination with LGG , reduces the incidence of late-onset sepsis in VLBW neonates . DESIGN , SETTING , AND PATIENTS Prospect i ve , multicenter , double-blind , placebo-controlled , r and omized trial conducted in 11 Italian tertiary neonatal intensive care units . Patients were 472 VLBW infants enrolled from October 1 , 2007 , through July 31 , 2008 , and assessed until discharge for development of sepsis . INTERVENTION Infants were r and omly assigned to receive orally administered BLF ( 100 mg/d ) alone ( n = 153 ) , BLF plus LGG ( 6 x 10(9 ) colony-forming units/d ) ( n = 151 ) , or placebo ( n = 168 ) from birth until day 30 of life ( day 45 for neonates First episode of late-onset sepsis , ie , sepsis occurring more than 72 hours after birth with isolation of any pathogen from blood or from peritoneal or cerebrospinal fluid . RESULTS Demographic , clinical , and management characteristics of the 3 groups were similar , including type of feeding and intake of maternal milk . Incidence of late-onset sepsis was significantly lower in the BLF and BLF plus LGG groups ( 9/153 [ 5.9 % ] and 7/151 [ 4.6 % ] , respectively ) than in the control group receiving placebo ( 29/168 [ 17.3 % ] ) ( risk ratio , 0.34 ; 95 % confidence interval , 0.17 - 0.70 ; P = .002 for BLF vs control and risk ratio , 0.27 ; 95 % confidence interval , 0.12 - 0.60 ; P bacterial and fungal sepsis . No adverse effects or intolerances to treatment occurred . CONCLUSION Compared with placebo , BLF supplementation alone or in combination with LGG reduced the incidence of a first episode of late-onset sepsis in VLBW neonates . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N53107700",
"OBJECTIVE . The goal was to investigate the efficacy of orally administered probiotics in preventing necrotizing enterocolitis for very low birth weight preterm infants . METHODS . A prospect i ve , blinded , r and omized , multicenter controlled trial was conducted at 7 NICUs in Taiwan , to evaluate the beneficial effects of probiotics in necrotizing enterocolitis among very low birth weight infants ( birth weight : and were assigned r and omly to 2 groups after parental informed consent was obtained . Infants in the study group were given Bifidobacterium bifidum and Lactobacillus acidophilus , added to breast milk or mixed feeding ( breast milk and formula ) , twice daily for 6 weeks . Infants in the control group were fed with breast milk or mixed feeding . The clinicians caring for the infants were blinded to the group assignment . The primary outcome measurement was death or necrotizing enterocolitis ( Bell 's stage ≥2 ) . RESULTS . Four hundred thirty-four infants were enrolled , 217 in the study group and 217 in the control group . The incidence of death or necrotizing enterocolitis ( stage ≥2 ) was significantly lower in the study group ( 4 of 217 infants vs 20 of 217 infants ) . The incidence of necrotizing enterocolitis ( stage ≥2 ) was lower in the study group , compared with the control group ( 4 of 217 infants vs 14 of 217 infants ) . No adverse effect , such as sepsis , flatulence , or diarrhea , was noted . CONCLUSION . Probiotics , in the form of Bifidobacterium and Lactobacillus , fed enterally to very low birth weight preterm infants for 6 weeks reduced the incidence of death or necrotizing enterocolitis",
"The objectives of this study were to determine whether or not the probiotic Lactobacillus GG can colonise the immature bowel of premature infants and if so , does colonisation result in a reduction of the size of the bowel reservoir of nosocomial pathogens such as enterobacteriaceae , enterococci , yeasts or staphylococci , and does colonisation with Lactobacillus GG have any effect on the clinical progress and outcome . Twenty preterm infants with a gestational age of 33 weeks or less who were resident on a neonatal unit were studied from the initiation of milk feeds until discharge . The infants were r and omised to receive either milk feeds or milk feeds supplemented with Lactobacillus GG 10(8 ) colony forming units twice a day for two weeks . The clinical features of the two groups of infants were similar . Orally administered Lactobacillus GG was well tolerated and did colonise the bowel of premature infants . However , colonisation with Lactobacillus GG did not reduce the faecal reservoir of potential pathogens and there was no evidence that colonisation had any positive clinical benefit for this particular group of infants",
"The study aim ed to find out whether gut colonisation of premature babies with a probiotic , Lactobacillus GG , modified enteric carbohydrate fermentation . Twenty preterm infants were r and omised to receive Lactobacillus GG 10(8 ) colony forming units twice a day for two weeks or to a control group . Faecal short chain fatty acids ( SCFAs ) , ethanol , and urinary 2,3-butanediol , were measured in parallel with microbiological studies . Lactobacillus GG colonised nine babies . From 1 - 28 days of age faecal SCFAs did not differ significantly from controls . Median and ranges were ( treated and controls , respectively ) : acetic acid : 173 ( trace-799 ) , 166 ( trace-700 ) ; propionic acid : 44 ( trace-169 ) , 37 ( 11 - 229 ) ; butyric acid : 31 ( 5 - 107 ) , 37 ( 2 - 118 ) mumol/g dry weight . Ethanol was detected in more faecal sample s from treated babies ( 65 % v 37 % ) , and at higher concentration ( 6.3 ( trace-40 ) v 3.3 ( 0.6 - 8.8 ; one 229 ) mumol/g ) . 2,3-Butanediol was found in 66 % of urine sample s from treated babies and 58 % from controls . On 83 % of these occasions Klebsiella sp , Enterobacter sp , or Serratia sp were cultured from faeces . Lactobacillus GG had no obvious adverse effects on nutritionally important SCFAs . The small increase in ethanol excretion is unlikely to have clinical significance",
"OBJECTIVE Late-onset sepsis ( occurring after 3 days of age ) is an important problem in very low birth weight ( VLBW ) infants . To determine the current incidence of late-onset sepsis , risk factors for disease , and the impact of late-onset sepsis on subsequent hospital course , we evaluated a cohort of 6956 VLBW ( 401 - 1500 g ) neonates admitted to the clinical centers of the National Institute of Child Health and Human Development Neonatal Research Network over a 2-year period ( 1998 - 2000 ) . METHODS The National Institute of Child Health and Human Development Neonatal Research Network maintains a prospect i ve registry of all VLBW neonates admitted to participating centers within 14 days of birth . Exp and ed infection surveillance was added in 1998 . RESULTS Of 6215 infants who survived beyond 3 days , 1313 ( 21 % ) had 1 or more episodes of blood culture-proven late-onset sepsis . The vast majority of infections ( 70 % ) were caused by Gram-positive organisms , with coagulase-negative staphylococci accounting for 48 % of infections . Rate of infection was inversely related to birth weight and gestational age . Complications of prematurity associated with an increased rate of late-onset sepsis included patent ductus arteriosus , prolonged ventilation , prolonged intravascular access , bronchopulmonary dysplasia , and necrotizing enterocolitis . Infants who developed late-onset sepsis had a significantly prolonged hospital stay ( mean length of stay : 79 vs 60 days ) . They were significantly more likely to die than those who were uninfected ( 18 % vs 7 % ) , especially if they were infected with Gram-negative organisms ( 36 % ) or fungi ( 32 % ) . CONCLUSIONS Late-onset sepsis remains an important risk factor for death among VLBW preterm infants and for prolonged hospital stay among VLBW survivors . Strategies to reduce late-onset sepsis and its medical , social , and economic toll need to be addressed urgently",
"BACKGROUND Preterm infants have increased intestinal permeability which can render them susceptible to infections from enterobacteriae . OBJECTIVES The primary objective was to investigate whether probiotic administration to preterm infants decreases intestinal permeability . Secondary outcomes studied were : somatic growth , tolerance , rates of sepsis and necrotizing enterocolitis . METHODS In a prospect i ve r and omized case-control study 41 stable preterm infants of 27 to 36 weeks gestation and 34 matched comparison infants consecutively admitted to the neonatal unit were studied . The study group received a preterm formula supplemented with Bifidobacter lactis ( 2 x 10(7 ) cfu/g of dry milk ) while the control group received the same formula but without supplementation . Intestinal permeability was measured within two days of birth and then seven and thirty days later using the sugar absorption test . Additionally anthropometric parameters were recorded throughout the study as well as acceptance and tolerance of the formula . RESULTS All infants tolerated the study formula well . Median counts of stool bifidobacteria and lactulose/mannitol ratios at baseline were comparable . After 7 days of supplementation median bifidobacteria counts were significantly higher in the study group than in the control group ( p=0.0356 ) and they remained higher to the end of the study ( p at day 30=0.075 ) . The L/M ratio in the study group was significantly lower at day 30 of the study as compared to the control group ( p=0.003 ) . Head growth was significantly higher in the study group ( p=0.001 ) . CONCLUSIONS The administration of a bifidobacter supplemented infant formula decreases intestinal permeability of preterm infants and leads to increased head growth",
"CONTEXT Neonatal infections are frequent complications of extremely low-birth-weight ( ELBW ) infants receiving intensive care . OBJECTIVE To determine if neonatal infections in ELBW infants are associated with increased risks of adverse neurodevelopmental and growth sequelae in early childhood . DESIGN , SETTING , AND PARTICIPANTS Infants weighing 401 to 1000 g at birth ( born in 1993 - 2001 ) were enrolled in a prospect ively collected very low-birth-weight registry at academic medical centers participating in the National Institute of Child Health and Human Development Neonatal Research Network . Neurodevelopmental and growth outcomes were assessed at a comprehensive follow-up visit at 18 to 22 months of corrected gestational age and compared by infection group . Eighty percent of survivors completed the follow-up visit and 6093 infants were studied . Registry data were used to classify infants by type of infection : uninfected ( n = 2161 ) , clinical infection alone ( n = 1538 ) , sepsis ( n = 1922 ) , sepsis and necrotizing enterocolitis ( n = 279 ) , or meningitis with or without sepsis ( n = 193 ) . MAIN OUTCOME MEASURES Cognitive and neuromotor development , neurologic status , vision and hearing , and growth ( weight , length , and head circumference ) were assessed at follow-up . RESULTS The majority of ELBW survivors ( 65 % ) had at least 1 infection during their hospitalization after birth . Compared with uninfected infants , those in each of the 4 infection groups were significantly more likely to have adverse neurodevelopmental outcomes at follow-up , including cerebral palsy ( range of significant odds ratios [ ORs ] , 1.4 - 1.7 ) , low Bayley Scales of Infant Development II scores on the mental development index ( ORs , 1.3 - 1.6 ) and psychomotor development index ( ORs , 1.5 - 2.4 ) , and vision impairment ( ORs , 1.3 - 2.2 ) . Infection in the neonatal period was also associated with impaired head growth , a known predictor of poor neurodevelopmental outcome . CONCLUSIONS This large cohort study suggests that neonatal infections among ELBW infants are associated with poor neurodevelopmental and growth outcomes in early childhood . Additional studies are needed to eluci date the pathogenesis of brain injury in infants with infection so that novel interventions to improve these outcomes can be explored",
"Studies were carried out on premature infants in the neonatal intensive care unit to determine the effect of feeding of lactobacilli on colonization of the gastrointestinal tract by antibiotic-resistant gram-negative enteric organisms . Thirty premature infants were matched by birth weight and gestational age , r and omized and fed double blind either lactobacilli-containing formula or non-lactobacilli-containing formula within 72 hours of delivery . The two study groups were screened weekly by culture for stool lactobacilli , for gram-negative bacteria and for antibiotic resistance of these bacteria . Lactobacilli were cultured from the stools of 13 of 15 patients receiving lactobacilli and from 3 of 15 patients not receiving lactobacilli ( P Gram-negative enteric organisms were isolated during 40 of the 86 weeks ( 47 % ) of hospitalization for patients receiving lactobacilli and during 28 of 57 weeks ( 49 % ) for patients not receiving lactobacilli . There was no significant difference between the study groups in the number of resistant organisms or in the proportion of resistant organisms per gram-negative enteric isolates ( 4 of 40 vs. 0 of 28 ) . These results suggest that facultative gram-negative enteric bacterial colonization , with either total or aminoglycoside-resistant strains , is not decreased by oral feedings of Lactobacillus acidophilus in premature infants",
"Background : It has been suggested that probiotics can reduce the overgrowth of pathogens in the bowels of preterm infants and contribute to the reduction of the incidence of nosocomial infections in neonatal intensive care units ( NICUs ) . The purpose of this study was to evaluate the effectiveness of Lactobacillus GG supplementation in reducing the incidence of urinary tract infections ( UTIs ) , bacterial sepsis and necrotizing enterocolitis ( NEC ) in preterm infants . Methods : A double-blind study was conducted in 12 Italian NICUs . Newborn infants with a gestational age were r and omized to receive st and ard milk feed supplemented with Lactobacillus GG ( Dicoflor ® , Dicofarm , Rome , Italy ) in a dose of 6 × 109 colony-forming units ( cfu ) once a day until discharge , starting with the first feed or placebo . Results : Five hundred eighty-five patients were studied . The probiotics group ( n = 295 ) and the placebo group ( n = 290 ) exhibited similar clinical characteristics . The duration of Lactobacillus GG and placebo supplementation was 47.3 ± 26.0 and 48.2 ± 24.3 days , respectively . Although UTIs ( 3.4 vs. 5.8 % ) and NEC ( 1.4 vs. 2.7 % ) were found less frequently in the probiotic group compared to the control group , these differences were not significant . Bacterial sepsis was more frequent in the probiotics group ( 4.4 % , n = 11 ) than in the placebo group ( 3.8 % , n = 9 ) , but the difference was not significant . Conclusion : Seven days of Lactobacillus GG supplementation starting with the first feed is not effective in reducing the incidence of UTIs , NEC and sepsis in preterm infants . Further studies are required to confirm our results in lower birthweight population",
"Objective : The objective of this trial was to test whether probiotic-supplemented feeding to extremely low-birth-weight ( ELBW ) infants will improve growth as determined by decreasing the percentage of infants with weight below the 10th percentile at 34 weeks postmenstrual age ( PMA ) . Other important outcome measures , such as improving feeding tolerance determined by tolerating larger volume of feeding per day and reducing antimicrobial treatment days during the first 28 days from the initiation of feeding supplementation were also evaluated . Study Design : We conducted a multicenter r and omized controlled double-blinded clinical study . The probiotics-supplementation ( PS ) group received Lactobacillus rhamnosus GG and Bifidobacterium infantis added to the first enteral feeding and continued once daily with feedings thereafter until discharge or until 34 weeks ( PMA ) . The control ( C ) group received unsupplemented feedings . Infant weight and feeding volumes were recorded daily during the first 28 days of study period . Weights were also recorded at 34 weeks PMA . Result : A total of 101 infants were enrolled ( PS 50 versus C 51 ) . There was no difference between the two groups in the percentage of infants with weight below the 10th percentile at 34 weeks PMA ( PS group 58 % versus C group 60 % , ( P value 0.83 ) ) or in the average volume of feeding during 28 days after study entry ( PS group 59 ml kg−1 versus C group 71 ml kg−1 , ( P value 0.11 ) ) . Calculated growth velocity was higher in the PS group compared with the C group ( 14.9 versus 12.6 g per day , ( P value 0.05 ) ) . Incidences of necrotizing enterocolitis ( NEC ) , as well as mortality were similar between the two groups . Conclusion : Although probiotic-supplemented feedings improve growth velocity in ELBW infants , there was no improvement in the percentage of infants with growth delay at 34 weeks PMA . There were no probiotic-related adverse events reported",
"Objective : To determine whether probiotics supplementation affects intestinal blood flow velocity in extremely low birth weight neonates . Study Design : In this r and omized , double-blind , placebo-controlled study , probiotics were added to the first enteral feeding and continued until discharge or 34 weeks postmenstrual age . Pulsed Doppler was used to measure prepr and ial and postpr and ial ( at 30 and 60 min ) time-averaged mean velocity ( TAMV ) , peak systolic velocity ( PSV ) and end diastolic velocity ( EDV ) during the second week of life after ⩾7 days of probiotics supplementation . Result : A total of 31 infants were studied , 15 were r and omized to the probiotic and 16 to the placebo groups . There was a significant postpr and ial increase in TAMV for the probiotic vs the placebo group ( P=0.035 ) , with PSV and EDV showing a trend . Demographic and clinical variables were similar between the groups . Conclusion : Probiotics administration significantly increases postpr and ial intestinal blood flow in extremely low birth weight preterm neonates when compared with the placebo group",
"OBJECTIVE Early-onset sepsis ( occurring within 72 hours of birth ) is included in the differential diagnosis of most very low birth weight ( VLBW ) neonates . To determine the current incidence of early-onset sepsis , risk factors for disease , and the impact of early-onset sepsis on subsequent hospital course , we studied a cohort of 7861 VLBW neonates ( 401 to 1500 gm ) admitted to the 12 National Institute of Child Health and Human Development ( NICHD ) Neonatal Research Network centers during a 32-month period ( 1991 - 1993 ) . METHODS The NICHD Neonatal Research Network maintains a prospect ively collected registry on all VLBW neonates born or cared for at participating centers . Data from this registry were analyzed retrospectively . RESULTS Blood culture-proven early-onset sepsis was uncommon , occurring in only 1.9 % of VLBW neonates . Group B streptococcus was the most frequent pathogen associated with early-onset sepsis ( 31 % ) , followed by Escherichia coli ( 16 % ) and Haemophilus influenzae ( 12 % ) . Decreasing gestational age was associated with increased rates of infection . Antibiotic therapy for suspected sepsis is frequently initiated at birth in VLBW neonates . Almost half of the infants in this cohort were considered to have clinical sepsis and continued to receive antibiotics for 5 or more days , despite a negative blood culture result in 98 % of cases . These findings underscore the difficulty of ruling out sepsis in the symptomatic immature neonate and the special concern for culture-negative clinical sepsis in the face of maternal antibiotic use . Neonates with early-onset sepsis were significantly more likely to have subsequent comorbidities , including severe intraventricular hemorrhage , patent ductus arteriosus , and prolonged assisted ventilation . Although 26 % of VLBW neonates with early-onset sepsis died , only 4 % of the 950 deaths that occurred in the first 72 hours of life were attributed to infection . For those infants discharged alive , early-onset sepsis was associated with a significantly prolonged hospital stay ( 86 vs 69 days ; p VLBW preterm infants . Improved diagnostic strategies are needed to enable the clinician to distinguish between the infected and the uninfected VLBW neonate with symptoms and to target continued antibiotic therapy to those who are truly infected",
"BACKGROUND Colonization by C and ida species is the most important predictor of the development of invasive fungal disease in preterm neonates , and the enteric reservoir is a major site of colonization . We evaluated the effectiveness of an orally supplemented probiotic ( Lactobacillus casei subspecies rhamnosus ; Dicoflor [ Dicofarm spa ] ; 6 x 10(9 ) cfu/day ) in the prevention of gastrointestinal colonization by C and ida species in preterm , very low birth weight ( i.e. , METHODS Over a 12-month period , a prospect i ve , r and omized , blind , clinical trial that involved 80 preterm neonates with a very low birth weight was conducted in a large tertiary neonatal intensive care unit . During the first 3 days of life , the neonates were r and omly assigned to receive either an oral probiotic added to human ( maternal or pooled donors ' ) milk ( group A ) or human milk alone ( group B ) for 6 weeks or until discharge from the NICU , if the neonate was discharged before 6 weeks . On a weekly basis , specimens obtained from various sites ( i.e. , oropharyngeal , stool , gastric aspirate , and rectal specimens ) were collected from all patients for surveillance culture , to assess the occurrence and intensity of fungal colonization in the gastrointestinal tract . RESULTS The incidence of fungal enteric colonization ( with colonization defined as at least 1 positive culture result for specimens obtained from at least 1 site ) was significantly lower in group A than in group B ( 23.1 % vs. 48.8 % ; relative risk , 0.315 [ 95 % confidence interval , 0.120 - 0.826 ] ; P = .01 ) . The numbers of fungal isolates obtained from each neonate ( P = .005 ) and from each colonized patient ( P = .005 ) were also lower in group A than in group B. L. casei subspecies rhamnosus was more effective in the subgroup of neonates with a birth weight of 1001 - 1500 g. There were no changes in the relative proportions of the different C and ida strains . No adverse effects potentially associated with the probiotic were recorded . CONCLUSIONS Orally administered L. casei subspecies rhamnosus significantly reduces the incidence and the intensity of enteric colonization by C and ida species among very low birth weight neonates",
"Background / Objective : The identification of probiotic species involved in gut homeostasis and their potential therapeutic benefits have led to an interest in their use for preventing necrotizing enterocolitis ( NEC ) . Although bifidobacterium and lactobacilli sp. have been used to reduce the incidence of NEC in clinical trials . Lactobacillus sporogenes has not been used in the prevention of NEC in very low-birth weight infants yet . The objective of this study was to evaluate the efficacy of orally administered L sporogenes in reducing the incidence and severity of NEC in very low-birth weight ( VLBW ) infants . Subjects/ Methods : A prospect i ve , blinded , r and omized controlled trial was conducted in preterm infants with a gestational age of The infants in the study group were given L. sporogenes with a dose of 350 000 000 c.f.u . added to breast milk or formula , once a day , starting with the first feed until discharged . The infants in the control group were fed without L. sporogenes supplementation . The primary outcome measurement was death or NEC ( Bell 's stage ⩾2 ) . Results : A total of 221 infants were studied : 110 in the study group and 111 in the control group . There was no significant difference in the incidence of death or NEC between the groups . Feeding intolerance was significantly lower in the probiotics group than in the control group ( 44.5 % ( n : 49 ) vs 63.1 % ( n : 70 ) , respectively ; P=0.006 ) . Conclusions : L. sporogenes supplementation at the dose of 350 000 000 c.f.u/day is not effective in reducing the incidence of death or NEC in VLBW infants , however , it could improve the feeding tolerance ",
"In a prospect i ve , r and omised study the effects of orally administered bifidobacteria on the intestinal microflora were investigated in 100 preterm and term neonates under intensive care conditions during the first 21 days of life . The 50 infants ( group with bifidobacteria ) received lyophilized bifidobacteria ( Töpfer Bifidus ) via nasogastral tube with an initial dosage of 3 times daily 1.25 x 10(8 ) bifidobacteria on day 2 of life and a daily dosage of 6 times 1.25 x 10(8 ) bifidobacteria on day 3 until day 21 of life . The other 50 infants ( control group ) did not receive bifidobacteria . The preterm and term neonates were fed either with pasteurized mother 's milk or milk from healthy female donors ( n = 79 ) or with an infant formula ( Alfaré , n = 13 ) or initially with Alfaré and thereafter with mother 's milk ( n = 8) . The intestinal microflora of preterm and term neonates under intensive care conditions could be influenced by the oral administration of bifidobacteria . The administration of bifidobacteria result ed in the group of inoculated infants in a significantly earlier colonization of bifidobacteria ( 8.1 + /- 3.9 days of life ) than in the control group ( 11.3 + /- 4.7 days of life ) . On day 7 a bifidobacterial dominance ( > 90 % of the intestinal microflora ) could be found in 26 % of infants with inoculation of bifidobacteria and only in 2 % of the control group ( p septicemia frequency between the two groups could not be demonstrated . At the beginning of the infection a bifidobacterial dominance was found in only one of 23 cases of septicemia",
"OBJECTIVE To test the hypothesis that normalizing the intestinal flora by administration of prophylactic probiotics would provide a natural defense , thereby reducing both the incidence and severity of necrotizing enterocolitis ( NEC ) in preterm neonates . STUDY DESIGN Neonates were r and omized to either receive a daily feeding supplementation with a probiotic mixture ( Bifidobacteria infantis , Streptococcus thermophilus , and Bifidobacteria bifidus ; Solgar , Israel ) of 10(9 ) colony forming units (CFU)/day or to not receive feed supplements . NEC was grade d according to Bell 's criteria . RESULTS For 72 study and 73 control infants , respectively , birth weight ( 1152 + /- 262 g vs 1111 + /- 278 g ) , gestational age ( 30 + /- 3 weeks vs 29 + /- 4 weeks ) , and time to reach full feeds ( 14.6 + /- 8.7 days vs 17.5 + /- 13.6 days ) were not different . The incidence of NEC was reduced in the study group ( 4 % vs 16.4 % ; P=.03 ) . NEC was less severe in the probiotic-supplemented infants ( Bell 's criteria 2.3 + /- 0.5 vs 1.3 + /- 0.5 ; P=.005 ) . Three of 15 babies who developed NEC died , and all NEC-related deaths occurred in control infants . CONCLUSION Probiotic supplementation reduced both the incidence and severity of NEC in our premature neonatal population",
"BACKGROUND Although recent reports suggest that supplementation with probiotics may enhance intestinal function in premature infants , the mechanisms are unclear , and questions remain regarding the safety and efficacy of probiotics in extremely low-birth-weight infants . OBJECTIVE The objective was to evaluate the efficacy of probiotics on the digestive tolerance to enteral feeding in preterm infants born with a very low or extremely low birth weight . DESIGN In a bicentric , double-blind , r and omized controlled clinical trial that was stratified for center and birth weight , 45 infants received enteral probiotics ( Bifidobacterium longum BB536 and Lactobacillus rhamnosus GG ; BB536-LGG ) and 49 received placebo . The primary endpoint was the percentage of infants receiving > 50 % of their nutritional needs via enteral feeding on the 14th day of life . A triangular test was used to perform sequential analysis . RESULTS The trial was discontinued after the fourth sequential analysis concluded a lack of effect . The primary endpoint was not significantly different between the probiotic ( 57.8 % ) and placebo ( 57.1 % ) groups ( P = 0.95 ) . However , in infants who weighed > 1000 g , probiotic supplementation was associated with a shortening in the time to reach full enteral feeding ( P = 0.04 ) . Other than colonization by the probiotic strains , no alteration in the composition of intestinal microbiota or changes in the fecal excretion of calprotectin was observed . No colonization by probiotic strains was detected in infants who weighed gastrointestinal tolerance to enteral feeding in very-low-birth-weight infants but may improve gastrointestinal tolerance in infants weighing > 1000 g. This trial was registered at clinical trials.gov as NCT 00290576",
"There have been over twenty prospect i ve , r and omized trials of the use of probiotics to prevent necrotizing enterocolitis ( NEC ) in premature babies . A Cochrane meta- analysis of 16 of the studies ( 1 ) including 2842 preterm infants , reported that ‘ enteral probiotics supplementation significantly reduced the incidence of severe NEC ( stage II or more ) ( typical RR , 0.35 ; 95 % CI , 0.24–0.52 ) and mortality ( typical RR , 0.40 ; 95 % CI , 0.27–0.60 ) with no evidence of harm . They concluded , ‘ Enteral supplementation of probiotics prevents severe NEC and all-cause mortality in preterm infants ’ . In a sensitivity analysis , including only the 4 highest quality studies , the results and conclusions were unchanged . For neonates born at , the number needed to treat in order to prevent one NEC or one death is twenty . The risks of probiotics are minimal . A more recently published systematic review included several additional r and omized controlled trials , mostly published in the Chinese literature , and analysed a total of 20 publications and over 3800 preterm infants ; it came to similar conclusions as the Cochrane meta- analysis ( 2 ) . Probiotics are used in many European units but only rarely in North-America . In spite of the evidence , this safe and effective treatment for one of the most serious complications of prematurity has never been studied in the United States and perhaps never will . Probiotics will probably never be approved by the U.S. Food and Drug Administration ( FDA ) . Instead , they will remain in regulatory purgatory , neither approved nor unapproved , an evidence -based treatment that can not become the st and ard of care , a safe and effective treatment that is not on hospital formularies in the United States . Probiotics fall into a peculiar lacuna of the regulatory system . Most innovative treatments are either drugs or devices , and the regulatory pathways for evaluating and approving them are fairly well defined by federal law . The FDA has jurisdiction over both drugs and devices . Probiotics are neither drugs nor devices , and they are made by companies that generally market health products to the general public . In contrast , in Canada , probiotics are under the jurisdiction of the Natural Health Products Directorate ( NHPD ) which has rigorous requirements for quality control and detailed labelling . But the NHPD does not evaluate overtly medical cl aims made about a product . It has little experience dealing with either a product that could actually decrease major complications or save lives in a particularly fragile population where mortality is rather common . Probiotics are quite inexpensive to manufacture . People can even make them at home . They are in most yogurts . For pennies , some parents buy them for their preterm infants in health food stores . Some mothers have started adding probiotics to their breast milk . In these cases , the medical team can either be unaware a preterm infant is in fact receiving probiotics or tacitly not interfere with these parental initiatives . Given the low cost of probiotics and Articles in the series A Different View are edited by William Meadow ( [email protected] ) . We encourage you to offer your own different view either in response to A Different View you do not fully agree with , or on an unrelated topic . Send your article to Dr. Meadow ( [email protected] )",
"AIM To investigate the colonisation withBifidobacterium breve of the bowels of very low birthweight ( VLBW ) infants . METHODS The adverse effects of B breve were examined in 66 VLBW infants ( preliminary study ) . A prospect i ve r and omised clinical study of 91 VLBW infants was also completed and these infants were followed up for three years . Precise viable bacterial counts of serial stool specimens were examined for the first eight weeks after birth in 10 infants . The colonisation rates of administered bacteria were examined using immunohistochemical staining of stool specimens with a B breve specific monoclonal antibody . RESULTS In the preliminary study there were no side effects attributable to the bacteria . Immunohistochemical staining of stool specimens showed that the colonisation rates of the administered bacteria were 73 % at 2 weeks of age , but only 12 % in the control group . Early administration of B brevesignificantly decreased aspirated air volume from the stomach and improved weight gain . CONCLUSIONS B breve can colonise the immature bowel very effectively and is associated with fewer abnormal abdominal signs and better weight gain in VLBW infants , probably as a result of stabilisation of their intestinal flora and accelerated feeding schedules",
"Background Colonization patterns , especially by anaerobic flora , may play an important role in neonatal gut function . Probiotics could affect disease risk either directly through colonization or indirectly by promoting changes in gut microbial ecology . Methods To study the ability of Lactobacillus GG ( LGG ) to colonize the neonatal gut and modify its microbial ecology , a prospect i ve , r and omized study was performed in 71 preterm infants of less than 2000 g birth weight . Infants less than 1500 g ( 24 treated , 15 control ) received 109 LGG orally twice daily for 21 days . Those infants weighing 1500 to 1999 g ( 23 treated , 9 control ) were treated for 8 days . Stools were collected before treatment and on day 7 to 8 ( and day 14 and 21 , in the infants weighing less than 1500 g ) for quantitative aerobic and anaerobic cultures . Results Colonization with LGG occurred in 5 of 24 ( 21 % ) infants who weighed less than 1500 g versus 11 of 23 ( 47 % ) in larger infants . Colonization was limited to infants who were not on antibiotics within 7 days of treatment with LGG . There was a paucity of bacterial species at baseline , although larger infants had more bacterial species ( 1.59 ± 0.13 ( SEM ) vs 1.11 ± 0.12;P mean log colony forming units ( CFU ) ( 8.79 ± 0.43 vs 7.22 ± 0.63;P significant increase in species number by day 7 , with further increases by day 21 . This increase was mainly the result of increased Gram ( + ) and anaerobic species . No difference in species number was noted in controls . Mean log CFU of Gram ( − ) bacteria did not change in treated infants weighing less than 1500 g. However , Gram ( + ) mean log CFU showed a significant increase on day 21 ( 6.1 ± 0.9 ) compared with day 0 ( 3.5 ± 0.9 ) ( P significant changes in species number or quantitative counts were noted after LGG treatment in the infants weighing 1500 to 1999 g LGG was well tolerated in all infants . Conclusion The neonatal response to a probiotic preparation is dependent on gestational and post-natal age and prior antibiotic exposure . Although LGG is a relatively poor colonizer in infants , especially those infants weighing less than 1500 g at birth , it does appear to affect neonatal intestinal colonization patterns ",
"Objective . We evaluated the efficacy of probiotics in reducing the incidence and severity of necrotizing enterocolitis ( NEC ) in very low birth weight ( VLBW ) infants . Patients and Methods . A prospect i ve , masked , r and omized control trial was conducted to evaluate the beneficial effects of probiotics in reducing the incidence and severity of NEC among VLBW ( the trial . They were r and omized into 2 groups after parental informed consents were obtained . The infants in the study group were fed with Infloran ( Lactobacillus acidophilus and Bifidobacterium infantis ) with breast milk twice daily until discharged . Infants in the control group were fed with breast milk alone . The clinicians caring for the infants were blinded to the group assignment . The primary outcome was death or NEC ( ≥ stage 2 ) . Results . Three hundred sixty-seven infants were enrolled : 180 in the study group and 187 in the control group . The demographic and clinical variables were similar in both groups . The incidence of death or NEC ( ≥ stage 2 ) was significantly lower in the study group ( 9 of 180 vs 24 of 187 ) . The incidence of NEC ( ≥ stage 2 ) was also significantly lower in the study when compared with the control group ( 2 of 180 vs 10 of 187 ) . There were 6 cases of severe NEC ( Bell stage 3 ) in the control group and none in the study group . None of the positive blood culture grew Lactobacillus or Bifidobacterium species . Conclusion . Infloran as probiotics fed enterally with breast milk reduces the incidence and severity of NEC in VLBW infants"
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OBJECTIVE Fatigue is an important outcome for patients with rheumatoid arthritis ( RA ) . The purpose of this study was to identify the scales being used to measure RA fatigue , and to systematic ally examine the evidence for their validation . METHODS Articles measuring fatigue in RA were sought using the terms RA and fatigue , and RA and tiredness , plus scale , question naire , inventory , and checklist . Index articles reporting identifiable RA fatigue data were examined for the fatigue scale used . Index and validation articles for each scale were review ed for evidence supporting scale validation to measure RA fatigue using a st and ardized checklist of content , face , criterion , and construct validity , reliability , and sensitivity to change . RESULTS A total of 61 index articles used 23 different fatigue scales to measure RA fatigue on 71 occasions . Seventeen scales had either no data on validation in RA or limited evidence . Reasonable evidence of validation was identified for 6 scales , each also having some evidence of sensitivity to change : ordinal scales , the Short Form 36 vitality subscale , the Functional Assessment of Chronic Illness Therapy Fatigue Scale , visual analog scales ( VAS ) , the Profile of Mood States , and the RA-specific Multidimensional Assessment of Fatigue scale ( MAF ) . However , the 4 generic scales would benefit from further validation in patients with RA , the VAS requires st and ardization , and the MAF would benefit from further sensitivity data . CONCLUSION It was possible to identify evidence of reasonable validation for 6 of 23 scales being used to measure RA fatigue . Research ers and clinicians should select scales to measure RA fatigue carefully | [
"Clinical measurement in rheumatoid arthritis ( RA ) has focused on articular problems . Although measures like the Health Assessment Question naire ( HAQ ) are widely used to determine functional impairment , there is a need to determine the overall effect of RA on general health status . We evaluated the relationship of a generic health status measure-the Nottingham Health Profile (NHP)-to the clinical , laboratory and radiological changes in the EULAR core data set for RA . Two hundred consecutive out- patients with RA were recruited . Their mean age was 58.9 yr and mean disease duration 11.3 yr . Patients completed the NHP and the following assessment s were made : the EULAR Core Data Set , the duration of morning stiffness , the Disease Activity Score ( DAS ) , rheumatoid factor ( RF ) levels , and Larsen 's score for X-rays of h and s and wrists . RA patients had higher scores on the NHP than both a r and om population sample and a second sample of patients with a variety of common diseases . NHP scores were not related to age or disease duration in RA . There was little relationship between perceived distress and the Larsen score , RF , ESR and C-reactive protein levels . Moderate associations were seen between NHP scores and disease activity measures , including the number of tender and swollen joints , pain and the duration of early morning stiffness , and also with a disability measure-the HAQ . NHP scores were highly related to disease activity measured by DAS . High DAS scores were associated with high scores in the energy level , pain and sleep sections of the NHP . The NHP gives relevant information about RA patients . They have high scores for pain , physical mobility and energy level sections , and also have high distress for sleep and emotional reactions",
"OBJECTIVE This study vali date d a brief measure of fatigue in rheumatoid arthritis ( RA ) , the Functional Assessment of Chronic Illness Therapy ( FACIT ) Fatigue Scale . METHODS The FACIT Fatigue was tested along with measures previously vali date d in RA : the Multidimensional Assessment of Fatigue ( MAF ) and Medical Outcomes Study Short-Form 36 ( SF-36 ) Vitality . The sample included 636 patients with RA enrolled in a 24 week double blind , r and omized clinical trial ( RCT ) of adalimumab versus placebo . RESULTS The FACIT Fatigue showed good internal consistency ( alpha = 0.86 to 0.87 ) , strong association with SF-36 Vitality ( r = 0.73 to 0.84 ) and MAF ( r = -0.84 to -0.88 ) , and the ability to differentiate patients according to clinical change using the American College of Rheumatology ( ACR ) response criteria ( ACR 20/50/70 ) . Psychometric performance of the FACIT Fatigue scale was comparable to that of the other 2 fatigue measures . A minimally important difference in FACIT Fatigue change score of 3 - 4 points was confirmed in a separate sample of 271 patients with RA enrolled in a second double blind RCT of adalimumab versus placebo . CONCLUSION The FACIT Fatigue is a brief , valid measure for monitoring this important symptom and its effects on patients with RA",
"OBJECTIVE Fatigue is commonly reported by patients with rheumatoid arthritis ( RA ) but is rarely a treatment target . The aim of this study was to explore the concept of fatigue as experienced by patients with RA . METHODS Fifteen patients with RA and fatigue ( > or = 7 on a 10-cm visual analog scale ) were individually interviewed and asked about the description , cause , consequence , and management of fatigue . Transcripts were systematic ally analyzed by 2 research ers independently , relevant phrases were coded , and earlier transcripts were checked for the emerging codes . A r and om sample of analyses were independently review ed . A total of 191 codes arising from the data were grouped into 46 categories and overarching themes . RESULTS Vivid descriptions reflect 2 types of fatigue : severe weariness and dramatic overwhelming fatigue . RA fatigue is different from normal tiredness because it is extreme , often not earned , and unresolving . Participants described physical , cognitive , and emotional components and attributed fatigue to inflammation , working the joints harder , and unrefreshing sleep . Participants described far-reaching effects on physical activities , emotions , relationships , and social and family roles . Participants used self-management strategies but with limited success . Most did not discuss fatigue with clinicians but when they did , they felt it was dismissed . Participants held negative views on the management of fatigue . CONCLUSION The data show that RA fatigue is important , intrusive , and overwhelming , and patients struggle to manage it alone . These data on the complexity of fatigue experiences will help clinicians design measures , interventions , and self-managment guidance",
"We report a prospect i ve , r and omized pilot study comparing a new workbook-based program , design ed to teach patients with rheumatoid arthritis ( RA ) energy conservation behaviors , with st and ard occupational therapy ( OT ) . Sixteen patients took part in the new program and nine received the st and ard therapy . Data on the number of tender or swollen joints , grip strength , walk time , activities of daily living , psychologic adjustment to illness , and daily activity log , were measured before and three months after intervention . Eleven percent of those who received st and ard therapy and 50 % of those who received the workbook increased their amount of physically active time ( p = .10 ) . Twenty-two percent of the control group and 50 % of those in the workbook group achieved a better balance of rest and physical activity ( p = .07 ) . We conclude that the adoption of energy conservation behaviors is different in the two groups . This initial study suggests that interrupting physical activity with rest periods may result in increased physical activity in patients with RA",
"The effects of 12 weeks of low-impact aerobic exercise on fatigue , aerobic fitness , and disease activity were examined in a quasi-experimental time series study of 25 adults with rheumatoid arthritis ( RA ) . Measures were obtained preintervention , midtreatment ( after 6 weeks of exercise ) , end of treatment ( after 12 weeks of exercise ) , and at a 15-week follow-up . ANOVAS for repeated measures showed that those subjects who participated more frequently reported decreased fatigue , while those who participated less frequently reported an increase in fatigue . All subjects , on average , showed increased aerobic fitness and increased right and left h and grip strength , decreased pain , and decreased walk time . There were no significant increases in joint count or sedimentation rate . Significant improvements in measures at the 15-week follow-up also were found . Findings indicate that persons with RA who participate in appropriate exercises may lessen fatigue levels and experience other positive effects without worsening their arthritis",
"Summary Three experimental question naires were compared with the Influence of Rheumatic Diseases on Health and Lifestyle ( IRGL ) question naire , a Dutch version of the Arthritis Impact Measurement Scales . Sixty-two patients with osteoarthritis ( OA ) and 35 patients with rheumatoid arthritis ( RA ) , all of whom underwent hip arthroplasty , completed the study . Results showed that visual analogue scales for pain , stiffness , fatigue , and anxiety were strongly correlated with a number of the IRGL scales . Patient preference scales were sensitive to change and provided additional information on aspects of the patients ' quality of life ( QOL ) that were felt to be important by the patients themselves . The question naire on performance in various roles in life was insensitive to change . In existing question naires , there is an attempt to represent the concept of QOL in terms of its most important aspects . Such realizations of the concept of QOL are not entirely suitable for application in clinical trials . The IRGL is overly complex , and its sometimes comprehensive scales do not deal with the possible effects of treatment . Neither of these properties is conducive to sensitivity to change . Visual analogue scales reduce the complexity . A simpler representation of QOL that can evaluate aspects relevant to treatment is recommended",
"A double-blind , cross-over trial compared the antiinflammatory and analgesic effects as well as tolerability of diclofenac sodium ( Voltaren ) and ibuprofen . Twenty-four out patients with rheumatoid arthritis were included . A single-blind placebo period was inserted between the two active treatments . The daily dose of diclofenac sodium was 50 mg bid and that of ibuprofen 400 mg tid . The duration of each treatment period was 14 days . The efficacy was measured by the following criteria : Articular index ( Lansbury ) , morning stiffness , fatigue , pain ( measured on a visual analogue scale ) , consumption of rescue-analgesics , status of the arthritic condition , and patient preference . No significant differences were found between diclofenac sodium and ibuprofen , but regarding consumption of analgesic , global evaluation , rheumatic activity , and activity index , a slight trend towards a better effect of diclofenac sodium was found . The study had an adequate sensitivity as it could distinguish placebo from the active treatments for all parameters evaluated . No patient was withdrawn for unwanted effects . None of the laboratory data showed abnormalities of clinical relevance",
"When any drug trial is being carried out it is essential that some criterion of improvement be available to assess the efficacy . In the ideal case there is one single measure , reliably and validly assessed , which is acceptable as this criterion . More frequently , however , there are several possible criteria . The usual practice is to deal with each separately and then in the discussion to point out which symptoms responded to treatment . Clinical ly this has obvious advantages in suggesting the appropriate applications of the treatment , but reliability will be increased if the various scores can be combined in some meaningful way . The unsophisticated way to do this is to add together the various scores , but there may be some clinical justification for weighting major symptoms more than minor ones and this can be done . In rheumatoid arthritis , Lansbury ( 1958 ) has been a keen advocate of indices . His Articular Index weighted the score on each joint by the area of joint ( Lansbury and Haut , 1956 ) and his Systemic Index based on morning stiffness , fatigue , aspirin need , grip strength , and erythrocyte sedimentation rate was believed to measure the inflammatory aspects of the disease ( Lansbury , 1956 ) . A double-blind cross-over trial of indomethacin , previously undertaken ( Wright , Walker , and McGuire , 1969 ) in 24 patients with rheumatoid arthritis to investigate the value of the drug compared with phenylbutazone and placebo , was set up in such a way that the Lansbury Systemic Index could be evaluated and the place of other indices determined . The results of this aspect of the study are reported in this paper",
"This paper presents the design and evaluation of an occupational therapy program developed at the National Institutes of Health for teaching energy conservation and joint protection to adults with rheumatoid arthritis . An existing model for educational diagnosis in health education was used to identify program , behavioral , and educational objectives for the new program . The use of this model result ed in measurable objectives , which were used as outcome measures in the r and omized research evaluation of the new program . The dependent variables measured were activity-of-daily-living status , psychosocial adjustment to illness , knowledge , disease activity , pain , and fatigue . None were significantly different after the intervention . The independent variables measured included components of balancing rest and physical activity . After 3 months , a greater percentage of the subjects receiving the workbook-based occupational therapy program than those receiving traditional occupational therapy demonstrated an application of the behaviors the intervention was design ed to change",
"OBJECTIVE To investigate whether treatment of anemia of chronic disease ( ACD ) in patients with rheumatoid arthritis ( RA ) with recombinant human erythropoietin ( rHu-Epo ) in combination with intravenous ( i.v . ) iron influences health related quality of life ( HRQoL ) and clinical outcome including disease activity . METHODS Thirty patients with ACD and RA were treated with 150 IU/kg rHu-Epo twice weekly for 12 weeks . As well , in case of functional iron deficiency 200 mg of iron-sucrose per week was given intravenously . Vitality and fatigue as dimensions of HRQoL were evaluated by the vitality subscale of the Short Form-36 ( SF-36-VT ) and the Multidimensional Assessment of Fatigue ( MAF ) . Muscle strength was measured by the Muscle Strength Index . RESULTS All 28 patients completing the study responded to treatment ; 23/28 patients developed functional iron deficiency and received i.v . iron ( mean absolute dose 710 + /- 560 mg ) . Average hemoglobin concentration increased from 10.7 + /- 1.1 to 13.2 + /- 1.0 g/dl after a mean treatment period of 8.7 + /- 2.3 weeks . Muscle strength increased from 43.5 + /- 11.2 to 49.1 + /- 12.9 and SF-36-VT from 28.2 % + /- 14.3 % to 47.1 % + /- 20.8 % . while fatigue decreased ( MAF from 34.7 + /- 9.3 to 25.0 + /- 11.3 ) . Among the disease activity variables the number of swollen/tender joints , erythrocyte sedimentation rate , Disease Activity Score , and RA Disease Activity Index improved significantly during treatment . CONCLUSION Treatment of ACD in RA patients with rHu-Epo and i.v . iron is safe and effective in correction of anemia , increases muscle strength . improves vitality , and lowers fatigue . In addition we observed a reduction of disease activity",
"ABSTRACT Cardiorespiratory function and exercise tolerance appear very limited in persons with rheumatoid arthritis ( RA ) . Many studies have demonstrated that aerobic exercise training is beneficial to prevent physical deconditioning without inducing adverse effects on an individual 's joints and general health . The present study was conducted to demonstrate that a dance-based exercise program is a safe and efficient activity to improve physical fitness and psychological state in persons with RA . A group of 19 persons ( mean age , 49.3 ± 13 yr ) participated in a 12-wk exercise program ( twice weekly ) , whereas 10 persons ( mean age , 49.4 ± 12 yr ) served as controls . Health status , use of medication , joint pain and swelling , physical fitness , activity of daily living and psychological state were assessed at baseline , after the 12-wk training program and 6 mo after the end of the program . Exercise training induced a mean improvement of 13 % in aerobic power , with the highest values reaching 40 % . No significant changes were observed in joint status , even though the count of painful joints tended to decrease in the exercise group . Positive changes in depression , anxiety , fatigue and tension were observed after the 12-wk exercise program . These findings provide some evidence s in favor of aerobic exercise in individuals with RA . Furthermore , it is of primary interest to note that a weight-bearing activity with limited ground impacts do not provoke short-term adverse effects on joint status . Further studies , however , are required to determine the long-term effect of weight-bearing exercise on the health status of individuals with RA"
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Problem : To address the complex phenomenon of pediatric obesity , one must underst and the physiological mechanisms regulating energy intake and inflammation . The peptide hormones leptin , ghrelin , and adiponectin are involved in both , but their functions are dysregulated in obesity . The purpose of this systematic review is ( 1 ) to characterize studies of nutrition interventions for weight management in children who measure these peptides as outcomes , ( 2 ) to assess risk of bias in the studies , and ( 3 ) to determine the relationships between these peptides and body mass index ( BMI ) . Eligibility Criteria : Peer- review ed articles written in English , published in 2001–2016 , and describing r and omized controlled trials of pediatric interventions involving a nutrition component with the outcome measures leptin , ghrelin , and /or adiponectin were included . Articles were excluded if the intervention involved pharmaceuticals , supplements , infant formula , breastfeeding , or surgery . Sample : The 25 international studies represented 2,153 obese children . Results : Ten diets were identified . Successful interventions included both structured exercise and hypocaloric dietary components , with or without counseling , resistance training , or medical components . Direct measures of adiposity were used in 69 % of studies . Comparison group design s were disparate . Leptin levels decreased as BMI decreased . Evidence regarding the relationships of ghrelin and adiponectin with BMI was inconclusive . Conclusions : Despite known effects of maturation on hormones , studies did not consistently differentiate findings by maturational stage . Common anti-inflammatory and disease risk modification diets were missing or underrepresented . Studies that include children with comorbidities are needed . BMI and leptin levels have a positive relationship , but evidence on ghrelin and adiponectin was inconclusive | [
"The purpose of this study was to examine ethnic differences in the metabolic responses to a 16-week intervention design ed to improve insulin sensitivity ( SI ) , adiposity , and inflammation in obese African-American and Latino adolescents . A total of 100 participants ( African Americans : n = 48 , Latino : n = 52 ; age : 15.4 ± 1.1 years , BMI percentile : 97.3 ± 3.3 ) were r and omly assigned to interventions : control ( C ; n = 30 ) , nutrition ( N ; n = 39 , 1 × /week focused on decreasing sugar and increasing fiber intake ) , or nutrition + strength training ( N+ST ; n = 31 , 2 × /week ) . The following were measured at pre- and postintervention : strength , dietary intake , body composition ( dual-energy X-ray absorptiometry/magnetic resonance imaging ) and glucose/insulin indexes ( oral glucose tolerance test (OGTT)/intravenous glucose tolerance test ( IVGTT ) ) and inflammatory markers . Overall , N compared to C and N+ST reported significant improvements in SI ( + 16.5 % vs. -32.3 % vs. -6.9 % respectively , P 0.01 ) and disposition index ( DI : + 15.5 % vs. -14.2 % vs. -13.7 % respectively , P reductions in hepatic fat fraction ( HFF : -27.3 % vs. -4.3 % vs. 0 % respectively , P reductions in plasminogen activator inhibitor-1 ( PAI-1 ) ( -38.3 % vs. + 1.0 % , P and resistin ( -18.7 % vs. + 11.3 % , P = 0.02 ) . There were no intervention effects for all other measures of adiposity or inflammation . Significant intervention by ethnicity interactions were found for African Americans in the N group who reported increases in total fat mass , 2-h glucose and glucose incremental areas under the curve ( IAUC ) compared to Latinos ( P 's improvements in SI and DI and N+ST reporting marked reductions in HFF and inflammation . Both ethnic groups had significant improvements in metabolic health ; however some improvements were not seen in African Americans",
"Adiponectin is an adipose-specific plasma protein whose plasma concentrations are decreased in obese subjects and type 2 diabetic patients . This protein possesses putative antiatherogenic and anti-inflammatory properties . In the current study , we have analyzed the relationship between adiponectin and insulin resistance in rhesus monkeys ( Macaca mulatta ) , which spontaneously develop obesity and which subsequently frequently progress to overt type 2 diabetes . The plasma levels of adiponectin were decreased in obese and diabetic monkeys as in humans . Prospect i ve longitudinal studies revealed that the plasma levels of adiponectin declined at an early phase of obesity and remained decreased after the development of type 2 diabetes . Hyperinsulinemic-euglycemic clamp studies revealed that the obese monkeys with lower plasma adiponectin showed significantly lower insulin-stimulated peripheral glucose uptake ( M rate ) . The plasma levels of adiponectin were significantly correlated to M rate ( r = 0.66 , P plasma adiponectin decreased in parallel to the progression of insulin resistance . No clear association was found between the plasma levels of adiponectin and its mRNA levels in adipose tissue . These results suggest that reduction in circulating adiponectin may be related to the development of insulin resistance",
"CONTEXT Hypoadiponectinemia and chronic sub clinical inflammation in adults are associated with the development of diabetes and cardiovascular disease . The potential relationship between adiponectin and inflammation and its modulation by lifestyle intervention in the pediatric obese population remain unclear . OBJECTIVES The objectives were to investigate in adolescents 1 ) the relationship between adiponectin and obesity-related inflammatory factors , C-reactive protein , and IL-6 ; and 2 ) the effect of a lifestyle intervention on adiponectin and whether these effects are related to changes in inflammatory factors . RESEARCH METHODS AND PROCEDURES Twenty-one obese and age-matched lean adolescents ( age , 14 - 18 yr ; Tanner stage , > or = IV ) were studied cross-sectionally . Fifteen obese adolescents also underwent a r and omized , controlled physical activity-behavior-diet-based lifestyle intervention for 3 months . Associations among adiponectin , fat mass , insulin resistance , and inflammatory factors at baseline as well as after the intervention were assessed . RESULTS Plasma adiponectin concentration was lower ( P adiponectin and inflammatory factors , insulinemia , insulin resistance , and fat mass . Intervention produced a 34 % increase in adiponectin concentration ( P = 0.0004 ) despite negligible weight loss but with reductions in fat mass , hyperinsulinemia , insulin resistance , and inflammatory factors ( all P that in adolescents , obesity-related hypoadiponectinemia is associated with sub clinical inflammation , and a short-term lifestyle intervention augments adiponectin concentrations . These effects appear to be related to reductions in fat mass and inflammatory factors . Based on our current underst and ing of adiponectin physiology , reversal of hypoadiponectinemia in obese adolescents may protect against risks for cardiovascular disease and diabetes",
"Background Obesity is significant problem involving eating behavior and peripheral metabolic conditions . The effect of carbohydrate and fat restriction on appetite regulation , fibroblast growth factor 21 ( FGF21 ) and leptin in children has not been defined . Our objective was to compare the effect of both diets . Methods One hundred and twenty children with body mass index ( BMI ) higher than the equivalent of 30 kg/m2 for an adult , as corrected for gender and age were r and omly assigned to ( n = 60 ) a low-carbohydrate ( L-CHO ) diet or ( n = 60 ) a low-fat ( L-F ) diet for 2 months . Fifty-three ( 88.3 % ) subjects on the low-carbohydrate-diet and 45 ( 75 % ) on the low-fat diet completed the study . Anthropometric measures , leptin and FGF21 levels were measured before and after the intervention . Comparison of the data for both of the diet groups was carried out using the t-test for independent variables . Intragroup comparisons before and after of each of the dietary treatments were performed using ANOVA for repeated measures . Factors associated with FGF21 , leptin levels and satiety , were analyzed by multiple regression . Results After both of the diets , weight , leptin , food responsiveness , and enjoyment of food significantly decreased and high density lipoprotein cholesterol ( HDL ) increased , but FGF21 decreased . Before and after both of the interventions FGF21 was associated with triglycerides . Before the diet , satiety was associated with lower screen time ( p insulin levels ( p obese children . FGF21 is an indicator of a beneficial metabolic response in younger children . After 2 months an adaptation of the eating behavior to food restriction was observed",
"BACKGROUND Gut hormones change with weight loss in adults but are not well studied in obese youth . OBJECTIVE The primary aim was to evaluate how gut hormones and subjective appetite measure change with dietary weight loss in obese adolescents . METHODS Participants were a subset of those taking part in the ' Eat Smart Study ' . They were aged 10 - 17 years with body mass index ( BMI ) > 90th centile and were r and omized to one of three groups : wait-listed control , structured reduced carbohydrate or structured low-fat dietary intervention for 12 weeks . Outcomes were fasting glucose , insulin , leptin , adiponectin , total amylin , acylated ghrelin , active glucagon-like peptide-1 , glucose-dependent insulinotropic polypeptide ( GIP ) , pancreatic polypeptide ( PP ) and total peptide tyrosine-tyrosine . Pre- and postpr and ial subjective sensations of appetite were assessed using visual analogue scales . RESULTS Of 87 ' Eat Smart ' participants , 74 participated in this sub- study . The mean ( st and ard deviation ) BMI z-score was 2.1 ( 0.4 ) in the intervention groups at week 12 compared with 2.2 ( 0.4 ) in the control group . Fasting insulin ( P = 0.05 ) and leptin ( P = 0.03 ) levels decreased , while adiponectin levels increased ( P = 0.05 ) in the intervention groups compared with control . The intervention groups were not significantly different from each other . A decrease in BMI z-score at week 12 was associated with decreased fasting insulin ( P homeostatic model of assessment -insulin resistance ( P leptin ( P total amylin ( P = 0.03 ) , GIP ( P = 0.01 ) , PP ( P = 0.02 ) and increased adiponectin ( P appetite sensations . CONCLUSIONS Modest weight loss in obese adolescents leads to changes in some adipokines and gut hormones that may favour weight regain",
"Little is known about the effects of different intensities of physical training on plasma leptin . This study examined the effect of two intensities of physical training on leptin in obese teenagers , and explored correlates at baseline and in response to 8 months of physical training . The participants were 55 obese youths 12 - 16 years of age who completed both baseline and posttesting . The youths were r and omized to engage in lifestyle education only ( LSE ) , moderate-intensity physical training and LSE , or high-intensity physical training and LSE . Baseline leptin was positively associated with fat mass . Girls had higher leptin levels at lower levels of fasting insulin than boys . The 8-mo physical training doses prescribed to obese teenagers did not result in significant group differences in mean change in leptin , although there was large variability in individual response . The change in leptin was inversely associated with baseline leptin and change in cardiovascular fitness . Diet , physical activity level , visceral adiposity , and glucose concentrations were not associated with leptin , neither at baseline nor in response to physical training . At baseline , total fat mass rather than visceral adiposity was associated with higher leptin levels . Over the 8-mo intervention period , regardless of group membership , youths who had the lowest increase in cardiovascular fitness tended to have the highest increase in leptin",
"Objective : A high-protein diet may decrease food intake through regulating satiety and appetite hormones and can be an effective strategy for weight loss . Few studies exist on obese Chinese adolescents . Methods and Material s : 156 obese Chinese adolescents were enrolled and r and omly assigned to one of two isoenergetic breakfasts , either with egg or steamed bread . Subsequent lunchtime food intake was recorded 4 h later . Appetite was assessed with a visual analog scale . Anorexigenic hormones peptide YY ( PYY ) , glucagon-like peptide-1 ( GLP-1 ) and orexigenic hormone ghrelin were determined with radioimmunoassay at 0 , 30 , and 180 min . Body weight was recorded . The tests were repeated 3 months later . Analysis was performed between two tests and then two groups . Pearson 's correlation was used for association analysis . Results : Subsequent lunchtime food intake and body weight were decreased while satiety was increased in subjects on an egg breakfast , which is associated with an increase of serum PYY and GLP-1 ( p weight loss , appetite , subsequent food intake and changes of appetite hormones . Conclusion : A high-protein breakfast promotes weight loss in obese Chinese adolescents , possibly through its regulation of satiety , subsequent food intake and appetite hormones",
"Abstract The objective of this study is to evaluate the effect of interdisciplinary therapy in the parameters of the oxidative stress and the anti-inflammatory responses of obese adolescents . We selected 57 participants , who were r and omly divided into 2 groups : interdisciplinary therapy group and a control group . After 6 months of intervention , 17 participants of the interdisciplinary therapy group and 8 of the control group returned for re-evaluation . The interdisciplinary therapy group participated in a treatment with 4 weekly sessions of exercise , a weekly group therapy session and a weekly nutritional education session . Blood parameters of oxidative stress and anti-inflammatory response were evaluated . The results demonstrated that there were significant increases in the interdisciplinary therapy group for superoxide dismutase activity ( 6.56 ± 3.22 to 11.40 ± 7.49 ) and ferric-reducing antioxidant potential concentration ( 532.91 ± 106.48 to 573.25 ± 112.57 ) , although adiponectin levels did not reduce ( 40.9 ± 29.34 to 49.05 ± 41.22 ) . A significant decrease in nitrite levels was also found ( 14.23 ± 8.48 to 11.45 ± 6.05 ) . In the control group , significant reduction was found in adiponectin ( 31.56 ± 18.88 to 18.01 ± 11.66 ) . This study suggests that interdisciplinary therapy for 6 months was effective in improving the anti-inflammatory responses and the antioxidant defences in obese adolescents",
"HYPOTHESIS Retraining obese adolescents to eat more slowly will lead to beneficial changes in circulating concentrations of gastrointestinal satiety hormones . METHODS Ghrelin and peptide tyrosine-tyrosine were measured during an oral glucose tolerance test , at baseline and at 12 months during a r and omized trial assessing the clinical effectiveness of a device ( M and ometer ) design ed to retrain eating behavior . This computerized scale provided real-time feedback during meals in the intervention arm ( n = 14 ) to slow down the speed of eating . The control group ( n = 13 ) received only st and ard care aim ed at improving lifestyle behavior . The M and ometer elicited greater improvements in weight loss than st and ard care . RESULTS Compared with baseline , only those using the M and ometer exhibited lower mean levels of fasting ghrelin ( 48.14 ± 18.47 vs. 68.45 ± 17.78 pg/ml ; P = 0.002 ) and mean ghrelin area under the curve ( 72.08 ± 24.11 vs. 125.50 ± 29.72 pg/ml × min ; P months . Absolute mean suppression in ghrelin at 60 min was enhanced ( -40.50 ± 21.06 vs. -12.14 ± 19.74 pg/ml × min ; P = 0.001 ) . Peptide tyrosine-tyrosine response at 90 min remained unaltered in the st and ard care arm , whereas those in the M and ometer arm increased ( P ) : the mean 90-min response increased by 72 pg/ml [ 95 % confidence interval ( CI ) 52 - 92 pg/ml ] between baseline and 12 months . In a partial correlation analysis adjusting for change ( Δ ) in body mass index sd scores , Δ meal duration correlated negatively with Δ absolute suppression in ghrelin at 60 min ( r = -0.58 ; P = 0.037 ; 95 % CI -0.79 to -0.27 ) and Δ ghrelin area under the curve ( r = -0.62 ; P = 0.025 ; 95 % CI -0.81 to -0.31 ) . CONCLUSIONS Retraining obese adolescents to eat more slowly has a significant impact on the gastrointestinal hormone response to a carbohydrate load , suggesting that externally modifiable eating behaviors actually regulate the hormonal response to food",
"SCOPE Whole-grain foods have been reported to affect serum levels of inflammatory cytokines . However , we are aware of no study examining the effect of whole-grain intake on inflammatory biomarkers among children . The present study aim ed to determine the effect of whole-grain intake on serum levels of inflammatory biomarkers in overweight or obese children . METHODS AND RESULTS In this r and omized crossover clinical trial , 44 overweight or obese girls aged 8 - 15 years participated . After a 2-week run-in period , subjects were r and omly assigned to either whole-grain or control groups . Subjects in the whole-grain group were given a list of whole-grain foods and were asked to obtain half of their needed servings of grains from whole-grain foods each day for 6 weeks . Individuals in the control group were also given a list of whole-grain foods and were asked not to consume any of these foods during the intervention phase of the study . A 4-week washout period was applied following which subjects were crossed over to the alternate arm for an additional 6 weeks . Fasting blood sample s were taken before and after each phase of the study to quantify markers of systemic inflammation . Mean age , weight , and BMI of study participants were 11.2 ± 1.49 years , 51.2 ± 10.2 kg , and 23.5 ± 2.5 kg/m(2 ) , respectively . No significant effect of whole-grain intake on weight and BMI was seen compared with the control group . We found a significant effect of whole-grain intake on serum levels of high-sensitive C-reactive protein ( -21.8 versus + 12.1 % , p = 0.03 ) , soluble intercellular adhesion molecule-1 ( -28.4 versus + 6.3 % , p = 0.02 ) , serum amyloid A ( -17.4 versus + 9.9 % , p = 0.02 ) , and leptin ( -9.7 versus + 39.2 % , p = 0.02 ) after 6 weeks . A trend toward the significant effect of whole-grain intake on serum levels of soluble vascular cell adhesion molecule-1 ( -36.2 % versus -7.8 % , p = 0.07 ) was also observed . CONCLUSION This study provides evidence supporting the beneficial effects of whole-grain foods on biomarkers of systemic inflammation in obese children",
"CONTEXT Risk factors for type 2 diabetes mellitus ( T2DM ) include obesity , family history , dyslipidemia , a proinflammatory state , impaired insulin secretory capacity , and insulin resistance . OBJECTIVE The aim of this study was to examine the effects of a 3- to 4-month school-based intervention consisting of health , nutrition , and exercise classes plus an aerobic exercise program on diabetes risk . DESIGN This study was a r and omized before/after controlled trial . METHODS Seventy-three eighth- grade students in a predominantly Hispanic New York City public school were divided into a control group ( studied twice without receiving the intervention ) and an experimental group ( studied before and after the intervention ) . OUTCOME MEASURES We measured body fatness ( bioelectrical impedance ) , insulin sensitivity , beta-cell function ( insulin release in response to an iv glucose load corrected for insulin sensitivity ) , lipid profiles , and circulating concentrations of IL-6 , C-reactive protein , adiponectin , and TNF-alpha . RESULTS Participation in the intervention was associated with significant reductions in body fatness , insulin resistance , and circulating concentrations of C-reactive protein and IL-6 , irrespective of somatotype on enrollment . CONCLUSION Short-term school-based health , nutrition , and exercise intervention is beneficial to all students and affects multiple diabetes risk factors",
"School-based interventions are an effective way to treat childhood obesity . The purpose of the present study was to biologically vali date an established school-based intervention design ed to reduce st and ardised body mass index ( z BMI ) over a period of 12 months . This intervention focused on a subset of Mexican-American children who were participating in a larger clinical weight loss study . Plasma sample s were analysed from self-identified Mexican-American children ( 12 - 14 years ) who were r and omised to either a school-based intervention ( IN , n = 152 ) or self-help control ( CN , n = 69 ) . Treatment was 4 days week⁻¹ of exercise ( 45 min day⁻¹ ) and 1 day week⁻¹ of nutritional counselling for 6 months . Fasting ( > 8 h ) blood sample s were collected at baseline , 6 months ( end of active intervention ) and 12 months ( 6 months after the end of the active intervention ) . Plasma resistin , adiponectin and leptin concentration were measured using a multiplex assay . Separate linear mixed models and a P for resistin ( P 0.0001 ) , adiponectin ( P = 0.001 ) and leptin ( P = 0.013 ) . For resistin , IN was 12 % lower at 6 months than CN . Adiponectin concentration in IN was greater at 6 months ( 26 % ) and 12 months ( 8 % ) than CN . Leptin concentration was 22 % lower for IN at 12 months than CN . We have previously reported that our school-based intervention reduced z BMI and now reported alterations in biologically relevant disease biomarkers . Some of the observed changes were only present at the end of the active intervention ( resistin ) , while others persisted until 12 months ( leptin and adiponectin ) . These changes underscore the effectiveness of our school-based intervention at not only improving z BMI but also at reducing disease risk",
"The aims of this study are to examine in children : ( i ) obesity-related alterations in satiety factors such as leptin , ghrelin , and obestatin ; ( ii ) the link between satiety factors and cardiometabolic risk factors ; and ( iii ) the impact of a physical activity-based lifestyle intervention on the levels of these satiety factors in the obese . We studied a total of 21 adolescents ( BMI percentile , 99.0 + /- 0.6 for 15 obese and 56.2 + /- 1.1 for 6 lean ) . The obese subjects underwent a 3-month r and omized controlled physical activity-based lifestyle intervention . Leptin , soluble leptin receptor ( sOB-R ) , ghrelin , and obestatin levels were determined as the primary outcome measures . Other markers of cardiometabolic disease such as inflammation and insulin resistance were also determined . Body composition was measured by dual-energy X-ray absorptiometry . The concentrations of ghrelin , obestatin , and sOB-R were significantly lower in the obese children compared to the lean controls , whereas that of leptin was higher ( all P obestatin ( P ghrelin levels , the balance between ghrelin and obestatin ( ratio of ghrelin to obestatin , G/O ) decreased ( P leptin and increased sOB-R ( P satiety factors and other cardiometabolic risk factors were also observed . Taken together , alterations in the levels of satiety factors are evident early in the clinical course of obesity , but physical activity-based lifestyle intervention either prevented their continued increase or normalized their levels . These beneficial effects appear to aid in the maintenance of body weight and reduction in cardiovascular risk",
"Background : Childhood obesity can cause the development of cardiovascular risk factors . We assessed the effect of a multidisciplinary intervention program on cardiovascular risk factors and compared this effect with a usual-care program in 3- to 5-y-old overweight or obese children . Methods : Seventy-five children were r and omly assigned to a multidisciplinary intervention or a usual-care program . Anthropometry , body composition , and abdominal adipose tissue were assessed at the start and end of a 16-wk program . Concurrently , fasting concentrations of serum lipids , glucose , insulin , HbA1c , leptin , adiponectin , high-sensitive C-reactive protein ( hsCRP ) , tumor necrosis factor (TNF)-α , and interleukin (IL)-6 were determined . Results : In both groups , insulin sensitivity improved , demonstrated by decreased insulin concentrations and a decreased HOMA2-IR . In the multidisciplinary intervention group , there was also a decrease of HbA1c and TNF-α . In the usual-care group , an increase in glucose concentrations was found . Comparing both groups , changes over time were not different , besides trends in the decrease in total cholesterol and TNF-α , in favor of the multidisciplinary intervention group . Combining the results of both groups , a correlation was found between the decrease in body fat percentage ( BF% ) , and both HOMA2-IR and triglyceride ( TG ) concentrations . Conclusion : In 3- to 5-y-old children , both obesity intervention programs improved insulin sensitivity , in parallel with a reduced BF%"
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Background Diabetes self-management education is an essential part of diabetes care , but its impact on all-cause mortality risk of type 2 diabetes patients is unclear . A systematic review and meta- analysis aim ing to eluci date the impact of diabetes self-management education on all-cause mortality risk of type 2 diabetes patients was performed . Methods R and omised controlled trials were identified though literature search in Medline , Embase , CENTRAL , conference abstract s , and reference lists . Only r and omised controlled trials comparing diabetes self-management education with usual care in type 2 diabetes patients and reporting outcomes after a follow-up of at least 12 months were considered eligible . Risk ratios with 95 % CIs were pooled . This study was registered at PROSPERO with the number of CRD42016043911 . Results 42 r and omised controlled trials containing 13,017 participants were included . The mean time of follow-up was 1.5 years . There was no heterogeneity among those included studies ( I2 = 0 % ) . Mortality occurred in 159 participants ( 2.3 % ) in the diabetes self-management education group and in 187 ( 3.1 % ) in the usual care group , and diabetes self-management education significantly reduced risk of all-cause mortality in type 2 diabetes patients ( pooled risk ratios : 0.74 , 95 % CI 0.60–0.90 , P = 0.003 ; absolute risk difference : −0.8 % , 95 % CI −1.4 to −0.3 ) . Both multidisciplinary team education and nurse-led education could significantly reduce mortality risk in type 2 diabetes patients , and the pooled risk ratios were 0.66 ( 95 % CI 0.46–0.96 , P = 0.02 ; I2 = 0 % ) and 0.64 ( 95 % CI 0.47– 0.88 , P = 0.005 ; I2 = 0 % ) , respectively . Subgroup analyses of studies with longer duration of follow-up ( ≥1.5 years ) or larger sample size ( ≥300 ) also found a significant effect of diabetes self-management education in reducing mortality risk among type 2 diabetes . Significant effect of diabetes self-management education in reducing mortality risk was also found in those patients receiving diabetes self-management education with contact hours more than 10 h ( pooled risk ratio : 0.60 , 95 % CI 0.44–0.82 , P = 0.001 ; I2 = 0 % ) , those receiving repeated diabetes self-management education ( pooled RR : 0.71 , P = 0.001 ; I2 = 0 % ) , those receiving diabetes self-management education using structured curriculum ( pooled risk ratio : 0.72 , P = 0.01 ; I2 = 0 % ) and those receiving diabetes self-management education using in-person communication ( pooled risk ratio : 0.75 , P = 0.02 ; I2 = 0 % ) . The quality of evidence for the effect of diabetes self-management education in reducing all-cause mortality risk among type 2 diabetes patients was rated as moderate according to the Grading of Recommendations Assessment , Development , and Evaluation method , and the absolute risk reduction of all-cause mortality of type 2 diabetic patients by diabetes self-management education was estimated to be 4 fewer per 1000 person-years ( from 1 fewer to 6 fewer ) . Conclusions The available evidence suggests that diabetes self-management education can reduce all-cause mortality risk in type 2 diabetes patients . Further clinical trials with longer time of follow-up are needed to vali date the finding above | [
"BACKGROUND African Americans suffer disproportionately from diabetes complications , but little research has focused on how to improve diabetic control in this population . There are also few or no data on a combined primary care and community-based intervention approach . METHODS We r and omly assigned 186 urban African Americans with type 2 diabetes ( 76 % female , mean A SD age 59 A 9 years ) to 1 of 4 parallel arms : ( 1 ) usual care only ; ( 2 ) usual care + nurse case manager ( NCM ) ; ( 3 ) usual care + community health worker ( CHW ) ; ( 4 ) usual care + nurse case manager/community health worker team . Using the framework of the Precede-Proceed behavioral model , interventions included patient counseling regarding self-care practice s and physician reminders . RESULTS The 2-year follow-up visit was completed by 149 individuals ( 84 % ) . Compared to the Usual care group , the NCM group and the CHW group had modest declines in HbA(1c ) over 2 years ( 0.3 and 0.3 % , respectively ) , and the combined NCM/CHW group had a greater decline in HbA(1c ) ( 0.8 % . P = 0.137 ) . After adjustment for baseline differences and /or follow-up time , the combined NCM/CHW group showed improvements in triglycerides ( -35.5 mg/dl ; P = 0.041 ) and diastolic blood pressure , compared to the usual care group ( -5.6 mmHg ; P = 0.042 ) . CONCLUSIONS Combined NCM/CHW interventions may improve diabetic control in urban African Americans with type 2 diabetes . Although results were clinical ly important , they did not reach statistical significance . This approach deserves further attention as a means to reduce the excess risk of diabetic complications in African Americans",
"BACKGROUND Cardiovascular disease ( CVD ) and diabetes account for one-third of the mortality difference between African American and white patients . We evaluated the effect of a CVD risk reduction intervention in African Americans with diabetes . METHODS We r and omized 359 African Americans with type 2 diabetes to receive usual care or a nurse telephone intervention . The 12-month intervention provided monthly self-management support and quarterly medication management facilitation . Co primary outcomes were changes in systolic blood pressure ( SBP ) , hemoglobin A1c ( HbA1c ) , and low-density lipoprotein cholesterol ( LDL-C ) over 12 months . We estimated between-intervention group differences over time using linear mixed-effects models . The secondary outcome was self-reported medication adherence . RESULTS The sample was 72 % female ; 49 % had low health literacy , and 37 % had annual income Model-based estimates for mean baseline SBP , HbA1c , and LDL-C were 136.8 mm Hg ( 95 % CI 135.0 - 138.6 ) , 8.0 % ( 95 % CI 7.8 - 8.2 ) , and 99.1 mg/dL ( 95 % CI 94.7 - 103.5 ) , respectively . Intervention patients received 9.9 ( SD 3.0 ) intervention calls on average . Primary providers replied to 76 % of nurse medication management facilitation contacts , 18 % of these result ed in medication changes . There were no between-group differences over time for SBP ( P = .11 ) , HbA1c ( P = .66 ) , or LDL-C ( P = .79 ) . Intervention patients were more likely than those receiving usual care to report improved medication adherence ( odds ratio 4.4 , 95 % CI 1.8 - 10.6 , P = .0008 ) , but adherent patients did not exhibit relative improvement in primary outcomes . CONCLUSIONS This intervention improved self-reported medication adherence but not CVD risk factor control among African Americans with diabetes . Further research is needed to determine how to maximally impact CVD risk factors in African American patients",
"Abstract OBJECTIVE : To examine the impact of a nurse-coordinated intervention delivered to patients with non-insulin-dependent diabetes mellitus between office visits to primary care physicians . DESIGN : R and omized , controlled trial . SETTING : Veterans Affairs general medical clinic . PATIENTS : 275 veterans who had NIDDM and were receiving primary care from general internists . INTERVENTION : Nurse-initiated contacts were made by telephone at least monthly to provide patient education ( with special emphasis on regimens and significant signs and symptoms of hyperglycemia and hypoglycemia ) , reinforce compliance with regimens , monitor patients ’ health status , facilitate resolution of identified problems , and facilitate access to primary care . MEASUREMENTS : Glycemic control was assessed using glycosylated hemoglobin ( GHb ) and fasting blood sugar ( FBS ) levels . Health-related quality of life ( HRQOL ) was measured with the Medical Outcomes Study SF-36 , and diabetes-related symptoms were assessed using patients ’ self-reports of signs and symptoms of hyper- and hypoglycemia during the previous month . MAIN RESULTS : At one year , between-group differences favored intervention patients for FBS ( 174.1 mg/dL vs 193.1 mg/dL , p=0.011 ) and GHb ( 10.5 % vs 11.1 % , p=0.046 ) . Statistically significant differences were not observed for either SF-36 scores ( p=0.66 ) or diabetes-related symptoms ( p=0.23 ) . CONCLUSIONS : The intervention , design ed to be a pragmatic , low-intensity adjunct to care delivered by physicians , modestly improved glycemic control but not HRQOL or diabetes-related symptoms ",
"Purpose The purpose of this study was to determine if improvements observed in clinical , behavioral , and psychosocial outcomes measured at 12 months following a multifaceted diabetes care intervention were sustained at 3-year follow-up . Methods This study was a multilevel , nonblinded , cluster design , r and omized controlled trial that took place in an under-served suburb of Pittsburgh , Pennsylvania , between 1999 and 2005 . Eleven primary care practice s , and their patients , were r and omly assigned to 3 groups : chronic care model ( CCM ) intervention ( n = 30 ) , provider education only ( PROV ) ( n = 38 ) , and usual care ( UC ) ( n = 51 ) . Subjects were followed for 3 years . Results Improvements observed at 12-month follow-up in glycemic ( —0.5 % ) and blood pressure control ( —4.8 mm Hg ) , and the proportion of participants who self-monitor their blood glucose ( 86.7%-100 % ) , were sustained at 3-year follow-up in the CCM group . Additional improvements occurred in non-HDLc levels in all study groups and quality of well-being scores in the CCM intervention group . All associations remained after controlling for medication treatment intensification . Conclusions We have demonstrated that improvements in outcomes can be sustained over time following a multifaceted diabetes care intervention . Future research in this area is necessary to underst and if improvements in outcomes can be sustained following diabetes self-management education ( DSME ) and what type of patient fares the best from multifaceted diabetes care interventions",
"Objectives To examine the impact of a successful 12-month behavioral intervention to improve diabetes control on health care utilization in American Samoa . Methods A cluster-r and omized design was used to assign 268 diabetes patients to a nurse-community health worker intervention or usual care . Hospitalizations , emergency department , and primary care physician visits were collected retrospectively for 1 year prior to , and during , the intervention to assess changes in health care utilization . The association of utilization changes with change in HbA1c during the intervention was assessed . Results Adjusted incidence rate ratios ( RR ) for primary care physician visits were significantly higher in the community health worker relative to the usual care group ( RR = 1.71 ; 95 % CI , 1.25–2.33 ) . There was no main intervention effect on emergency department utilization , but visits in the prior year modified the intervention effect on emergency department visits . Increased primary care physician utilization was associated with greater decreases in HbA1c ( b = −0.10 , SE = 0.04 , p = 0.01 ) . Conclusions A culturally adapted community health worker diabetes intervention in American Samoa significantly increased primary care physician visits , and decreased emergency department visits among those with high emergency department usage in the prior year . These changes suggest important and beneficial impacts on health system utilization from the diabetes intervention in a low re source and high-risk population",
"OBJECTIVE Latinos with type 2 diabetes ( T2D ) face major healthcare access and disease management disparities . We examined the impact of the Diabetes Among Latinos Best Practice s Trial ( DIALBEST ) , a community health worker (CHW)–led structured intervention for improving glycemic control among Latinos with T2D . RESEARCH DESIGN AND METHODS A total of 211 adult Latinos with poorly controlled T2D were r and omly assigned to a st and ard of healthcare ( n = 106 ) or CHW ( n = 105 ) group . The CHW intervention comprised 17 individual sessions delivered at home by CHWs over a 12-month period . Sessions addressed T2D complications , healthy lifestyles , nutrition , healthy food choices and diet for diabetes , blood glucose self-monitoring , and medication adherence . Demographic , socioeconomic , lifestyle , anthropometric , and biomarker ( HbA1c , fasting blood glucose , and lipid profile ) data were collected at baseline and 3 , 6 , 12 , and 18 months ( 6 months postintervention ) . Groups were equivalent at baseline . RESULTS Participants had high HbA1c at baseline ( mean 9.58 % [ 81.2 mmol/mol ] ) . Relative to participants in the control group , CHWs had a positive impact on net HbA1c improvements at 3 months ( −0.42 % [ −4.62 mmol/mol ] ) , 6 months ( −0.47 % [ −5.10 mmol/mol ] ) , 12 months ( −0.57 % [ −6.18 mmol/mol ] ) , and 18 months ( −0.55 % [ −6.01 mmol/mol ] ) . The overall repeated- measures group effect was statistically significant ( mean difference −0.51 % [ −5.57 mmol/mol ] , 95 % CI −0.83 , −0.19 % [ −9.11 , −2.03 mmol/mol ] , P = 0.002 ) . CHWs had an overall significant effect on fasting glucose concentration that was more pronounced at the 12- and 18-month visits . There was no significant effect on blood lipid levels , hypertension , and weight . CONCLUSIONS DIALBEST is an effective intervention for improving blood glucose control among Latinos with T2D",
"BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus , but no large trials have compared interventions . We investigated the effects of diet and physical activity on blood pressure and glucose concentrations . METHODS We did a r and omised , controlled trial in southwest Engl and in adults aged 30 - 80 years in whom type 2 diabetes had been diagnosed 5 - 8 months previously . Participants were assigned usual care ( initial dietary consultation and follow-up every 6 months ; control group ) , an intensive diet intervention ( dietary consultation every 3 months with monthly nurse support ) , or the latter plus a pedometer-based activity programme , in a 2:5:5 ratio . The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c ) ) concentration and blood pressure at 6 months . Analysis was done by intention to treat . This study is registered , number IS RCT N92162869 . FINDINGS Of 593 eligible individuals , 99 were assigned usual care , 248 the diet regimen , and 246 diet plus activity . Outcome data were available for 587 ( 99 % ) and 579 ( 98 % ) participants at 6 and 12 months , respectively . At 6 months , glycaemic control had worsened in the control group ( mean baseline HbA(1c ) percentage 6·72 , SD 1·02 , and at 6 months 6·86 , 1·02 ) but improved in the diet group ( baseline-adjusted difference in percentage of HbA(1c ) -0·28 % , 95 % CI -0·46 to -0·10 ; p=0·005 ) and diet plus activity group ( -0·33 % , -0·51 to -0·14 ; p seen in bodyweight and insulin resistance between the intervention and control groups . Blood pressure was similar in all groups . INTERPRETATION An intensive diet intervention soon after diagnosis can improve glycaemic control . The addition of an activity intervention conferred no additional benefit . FUNDING Diabetes UK and the UK Department of Health",
"PURPOSE To evaluate the effects of a collaborative case management intervention for patients with poorly controlled type 2 diabetes on glycemic control , intermediate cardiovascular outcomes , satisfaction with care , and re source utilization . METHODS We conducted a r and omized controlled trial at two Department of Veterans Affairs Medical Centers involving 246 veterans with diabetes and baseline hemoglobin A(1C ) ( HbA(1C ) ) levels > or=7.5 % . Two nurse practitioner case managers worked with patients and their primary care providers , monitoring and coordinating care for the intervention group for 18 months through the use of telephone contacts , collaborative goal setting , and treatment algorithms . Control patients received educational material s and usual care from their primary care providers . RESULTS At the conclusion of the study , both case management and control patients remained under poor glycemic control and there was little difference between groups in mean exit HbA(1C ) level ( 9.3 % vs. 9.2 % ; difference = 0.1 % ; 95 % confidence interval : -0.4 % to 0.7 % ; P = 0.65 ) . There was also no evidence that the intervention result ed in improvements in low-density lipoprotein cholesterol level or blood pressure control or greater intensification in medication therapy . However , intervention patients were substantially more satisfied with their diabetes care , with 82 % rating their providers as better than average compared with 64 % of patients in the control group ( P = 0.04 ) . CONCLUSION An intervention of collaborative case management did not improve key physiologic outcomes for high-risk patients with type 2 diabetes . The type of patients targeted for intervention , organizational factors , and program structure are likely critical determinants of the effectiveness of case management . Health systems must underst and the potential limitations before expending substantial re sources on case management , as the expected improvements in outcomes and downstream cost savings may not always be realized",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"OBJECTIVE To evaluate the efficacy of ongoing group based diabetes self-management education ( DSME ) for patients with type 2 diabetes . METHODS 146 patients were r and omised to either group education or waiting list control . Primary outcomes were A1C and patient activation measured with patient activation measure ( PAM ) . RESULTS There were no differences in the primary outcomes between the groups at 12 months , but the control group had an increase in A1C of 0.3 % points during follow-up . Diabetes knowledge and some self-management skills improved significantly in the intervention group compared to the control group . A sub group analysis was conducted for the quartile with the highest A1C at baseline ( > 7.7 , n=18 in both groups ) . There were significant improvements within the intervention group at 12 month follow-up for both A1C and PAM and a trend for better outcome in the intervention group compared to the control . CONCLUSIONS The locally developed ongoing diabetes self-management education programs prevented an increase in A1C and can have an effect on A1C in patients with higher A1C level . PRACTICE IMPLICATION S Locally developed programs may be less effective than programs developed for studies",
"Objective To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years . Design Three year follow-up of a multicentre cluster r and omised controlled trial in primary care , with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 731 of the 824 participants included in the original trial were eligible for follow-up . Biomedical data were collected on 604 ( 82.6 % ) and question naire data on 513 ( 70.1 % ) participants . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures The primary outcome was glycated haemoglobin ( HbA1c ) levels . The secondary outcomes were blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , emotional impact of diabetes , and drug use at three years . Results HbA1c levels at three years had decreased in both groups . After adjusting for baseline and cluster the difference was not significant ( difference −0.02 , 95 % confidence interval −0.22 to 0.17 ) . The groups did not differ for the other biomedical and lifestyle outcomes and drug use . The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years ( P life did not differ at three years . Conclusion A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs . Trial registration Current Controlled Trials IS RCT N17844016",
"The aim of the present study was to evaluate the impact of empowerment group education on type 2 diabetes patients ' confidence in diabetes knowledge , self-efficacy , satisfaction with daily life , BMI and glycaemic control compared with the impact of routine diabetes care on the same factors at a 1-year follow-up . In this r and omized controlled trial , conducted at 7 primary care centres in central Sweden , 101 patients were r and omly assigned either to empowerment group education ( intervention group ) or to routine diabetes care ( control group ) . Out of these , 42 patients in the intervention group and 46 in the control group completed the 1-year follow-up . Before the intervention and at the 1-year follow-up , the patients answered a 27-item question naire , and weight , BMI and HbA1c were measured . The question naire comprised three domains : confidence in diabetes knowledge , self-efficacy and satisfaction with daily life . At 1-year follow-up , the level of confidence in diabetes knowledge was significantly higher in the intervention group than in the control group ( p self-efficacy , satisfaction with daily life , BMI and HbA1c between the intervention and control group . The empowerment group education did improve patients ' confidence in diabetes knowledge with maintained glycaemic control despite the progressive nature of the disease",
"OBJECTIVES The aim of the present study was to develop , implement and evaluate a brief intervention to improve adherence to the recommended lifestyle changes for patients with Type 2 diabetes , in particular to help patients to reduce the total amount of fat consumed and to increase lifestyle physical activity levels . DESIGN AND METHOD A brief , tailored lifestyle self-management intervention for patients with Type 2 diabetes was evaluated in a r and omized controlled trial . One hundred participants ( aged 40 - 70 yrs ) completed assessment s at three time points- baseline , three months and one year . Participants were allocated to either an intervention group who received the brief tailored intervention including follow-up telephone calls , or a usual care control group . RESULTS Results indicate that the intervention was successful in helping patients to reduce fat intake and , to a lesser extent , increase lifestyle physical activity levels . These self-reported changes in behaviour were reflected in the objective data with weight maintenance in the intervention group compared to the control group , together with a significant reduction ( 2 cm ) in waist circumference . CONCLUSIONS These results provide further evidence of the effectiveness of tailored interventions for lifestyle change",
"OBJECTIVE To evaluate the effectiveness of a telephone-delivered behavioral weight loss and physical activity intervention targeting Australian primary care patients with type 2 diabetes . RESEARCH DESIGN AND METHODS Pragmatic r and omized controlled trial of telephone counseling ( n = 151 ) versus usual care ( n = 151 ) . Reported here are 18-month ( end-of-intervention ) and 24-month ( maintenance ) primary outcomes of weight , moderate-to-vigorous-intensity physical activity ( MVPA ; via accelerometer ) , and HbA1c level . Secondary outcomes include dietary energy intake and diet quality , waist circumference , lipid levels , and blood pressure . Data were analyzed via adjusted linear mixed models with multiple imputation of missing data . RESULTS Relative to usual-care participants , telephone counseling participants achieved modest , but significant , improvements in weight loss ( relative rate [ RR ] −1.42 % of baseline body weight [ 95 % CI −2.54 to −0.30 % of baseline body weight ] ) , MVPA ( RR 1.42 [ 95 % CI 1.06–1.90 ] ) , diet quality ( 2.72 [ 95 % CI 0.55–4.89 ] ) , and waist circumference ( −1.84 cm [ 95 % CI −3.16 to −0.51 cm ] ) , but not in HbA1c level ( RR 0.99 [ 95 % CI 0.96–1.02 ] ) , or other cardio-metabolic markers . None of the outcomes showed a significant change/deterioration over the maintenance period . However , only the intervention effect for MVPA remained statistically significant at 24 months . CONCLUSIONS The modest improvements in weight loss and behavior change , but the lack of changes in cardio-metabolic markers , may limit the utility , scalability , and sustainability of such an approach",
"OBJECTIVE We evaluated automated telephone disease management ( ATDM ) with telephone nurse follow-up as a strategy for improving diabetes treatment processes and outcomes in Department of Veterans Affairs ( VA ) clinics . We also compared the results with those of a prior ATDM trial conducted in a county health care system . RESEARCH DESIGN AND METHODS A total of 272 VA patients with diabetes using hypoglycemic medications were r and omized . During the 1-year study period , intervention patients received biweekly ATDM health assessment and self-care education calls , and a nurse educator followed up with patients based on their ATDM assessment reports . Telephone surveys were used to measure patients ' self-care , symptoms , and satisfaction with care . Outpatient service use was evaluated using electronic data bases and self-reports , and glycemic control was measured by HbA1c and serum glucose testing . RESULTS At 12 months , intervention patients reported more frequent glucose self-monitoring and foot inspections than patients receiving usual care and were more likely to be seen in podiatry and diabetes specialty clinics . Intervention patients also were more likely than control patients to have had a cholesterol test . Among patients with baseline HbA1c levels > or = 8 % , mean end-point values were lower among intervention patients than control patients ( 8.7 vs. 9.2 % , respectively ; P = 0.04 ) . Among intervention and control patients with baseline values > or = 9 % , mean end-point values were 9.1 and 10.2 % , respectively ( P = 0.04 ) . At follow-up , intervention patients reported fewer symptoms of poor glycemic control than control patients and greater satisfaction with their health care . CONCLUSIONS This intervention improved the quality of VA diabetes care . Intervention effects for most end points replicated findings from the prior county clinic trial , although intervention-control differences in the current study were smaller because of the relatively good self-care and health status among the current study 's enrollees",
"Objective To evaluate the effectiveness of goal focused telephone coaching by practice nurses in improving glycaemic control in patients with type 2 diabetes in Australia . Design Prospect i ve , cluster r and omised controlled trial , with general practice s as the unit of r and omisation . Setting General practice s in Victoria , Australia . Participants 59 of 69 general practice s that agreed to participate recruited sufficient patients and were r and omised . Of 829 patients with type 2 diabetes ( glycated haemoglobin ( HbA1c ) > 7.5 % in the past 12 months ) who were assessed for eligibility , 473 ( 236 from 30 intervention practice s and 237 from 29 control practice s ) agreed to participate . Intervention Practice nurses from intervention practice s received two days of training in a telephone coaching programme , which aim ed to deliver eight telephone and one face to face coaching episodes per patient . Main outcome measures The primary end point was mean absolute change in HbA1c between baseline and 18 months in the intervention group compared with the control group . Results The intervention and control patients were similar at baseline . None of the practice s dropped out over the study period ; however , patient attrition rates were 5 % in each group ( 11/236 and 11/237 in the intervention and control group , respectively ) . The median number of coaching sessions received by the 236 intervention patients was 3 ( interquartile range 1 - 5 ) , of which 25 % ( 58/236 ) did not receive any coaching sessions . At 18 months ’ follow-up the effect on glycaemic control did not differ significantly ( mean difference 0.02 , 95 % confidence interval −0.20 to 0.24 , P=0.84 ) between the intervention and control groups , adjusted for HbA1c measured at baseline and the clustering . Other biochemical and clinical outcomes were similar in both groups . Conclusions A practice nurse led telephone coaching intervention implemented in the real world primary care setting produced comparable outcomes to usual primary care in Australia . The addition of a goal focused coaching role onto the ongoing generalist role of a practice nurse without prescribing rights was found to be ineffective . Trial registration Current Controlled Trials IS RCT N50662837",
"Objective In a r and omized 5-yr multi-intervention trial , we tested the efficacy of intensified health education ( IHE ) in improving metabolic control and reducing the level of coronary risk factors and incidence of ischemic heart disease ( IHD ) . Research Design and Methods Within the intervention group , the benefit of clofibric acid was evaluated in a double-blind study . One thous and one hundred thirty-nine newly diagnosed middle-aged ( 30- to 55-yr-old ) patients with non-insulindependent diabetes mellitus ( NIDDM ) entered the study . They were classified as diet controlled after a 6- wk screening phase with conventional dietary treatment . During the follow-up , the control group ( n = 378 ) was cared for at different diabetes outpatient clinics with a st and ardized surveillance . The intervention group ( n = 761 ) had a structured IHE that included dietary advice , antismoking and antialcohol education , and ways to enhance physical activity . Results R and omly , 379 of the IHE patients received 1.6 g clofibric acid/day , and the others received placebo . IHE result ed in improved glucose control ( adjusted fasting blood glucose ) levels after 5 yr ( control subjects 9.27 mM , IHE group 8.71 mM , and IHE plus clofibric acid group 8.60 mM , P better glycemic control was achieved with fewer antidiabetic drugs . After 5 yr , antidiabetic drugs were prescribed to 47 % of the control subjects , 28 % of the IHE group , and 34 % of the IHE plus clofibric acid group ( cutoff limit for drug application was postpr and ial blood glucose of ≥13.87 mM ) . The ratio of polyunsaturated to saturated fatty acids ( 0.26 vs. 0.40 , P 0.01 ) and physical activity ( 174 vs. 327 scores , P , and blood pressure , tobacco , and alcohol consumption were significantly reduced by IHE . However , IHE had no effect on calorie intake , percentage of fat in the diet ( 45 % ) , and body weight . The most important finding was the significant increase of blood cholesterol in all three groups ( + 0.47 , + 0.36 , and + 0.34 mM , respectively ) . Clofibric acid only prevented the increase of triglyceride levels ( + 0.56 , + 0.24 , and + 0.05 mM , respectively ) . The incidence rate per 1000 for myocardial infa rct ion was 30.3 for control subjects , 53.6 for the IHE group , and 55.6 for the IHE plus clofibric acid group . The corresponding rates for IHD incidence were 90.9 , 97.8 , and 98.8 , respectively . Men suffered more frequently from myocardial infa rct ion , whereas women developed ECG criteria for IHD more frequently . Among the 35 cases of death , besides cardiovascular diseases , liver cirrhosis and neoplasia were the predominant causes . The death rate per 1000 in control subjects was 46.2 , 30.6 in the IHE group , and 27 among patients with IHE plus clofibric acid . Conclusions IHE was of substantial benefit for the control of glycemia , significantly diminished the need for antidiabetic drugs , and reduced a cluster of risk factors but had no effect on the control of blood lipids . This could be one major reason for the failure of IHE , effective lowering of blood pressure , and clofibric acid to prevent cardiovascular complications . Clofibric acid was only effective in reducing triglycerides",
"We have assessed the effect of a structured , empowerment-based educational system ( \" LAY or \" Look After Yourself \" ) for patients with type 2 diabetes . A r and omised controlled trial ( RCT ) was conducted , testing the system against st and ard support . Using 3 centres , 89 patients participated in the study . Outcome measures included glycated haemoglobin ( HbA(1c ) ) , body mass index ( BMI ) and a variety of quantitative psychological and educational measures . Assessment was made at 6 months ( \" short-term \" ) and 12 months ( \" long-term \" ) post-intervention . The educational programme was associated with benefits in HbA(1c ) levels ( p=0.005 ) , illness attitudes ( p=0.04 ) , and perceived treatment effectiveness ( p=0.03 ) at 6 months follow-up compared to controls . At 12 months however , only illness attitudes ( p=0.01 ) , and self-monitoring ( p=0.002 ) showed benefit . A combined outcome measure showed positive benefit for the educational programme both at 6 months ( p=0.001 ) and 12 months ( p=0.002 ) . This structured educational programme , aim ed at encouraging self-help , was associated with only limited benefits in glycaemic control , but there were significant educational and psychological benefits . Diabetes education should be regarded as having broad patient-based positive outcomes , and should not be expected to have lasting benefits on glycaemic control",
"OBJECTIVES To evaluate whether outcomes from diabetes self-management education for patients with suboptimal control were sustained . STUDY DESIGN A r and omized controlled trial of 623 adults with type 2 diabetes and glycated hemoglobin ( A1C ) > 7 % assigned to receive conventional individual education ( IE ) , group education ( GE ) using US Diabetes Conversation Maps , or usual care ( UC ) with no education . METHODS A1C tests , Problem Areas in Diabetes ( PAID ) , Diabetes Self-Efficacy ( DES ) , Recommended Food Score ( RFS ) , physical activity , and medication use were quantified at baseline and 1 year of follow-up through electronic health records and quarterly mailed surveys . Short-term ( mean 6.8 months ) and long-term ( 12.8 months ) outcomes were evaluated using linear mixed models . In addition , follow-up trajectories were plotted in a r and om effects generalized additive model with smooth splines . RESULTS Compared with UC , IE result ed in long-term improved DES and PAID scores ( DES , + .11 , P = .03 and PAID , -2.94 , P = .04 ) , but not significantly improved long-term RFS or physical activity change . The A1C trajectory declined more steeply in IE than GE and UC for the first 150 days post r and omization . However , by 250 days , there was no treatment group A1C difference . The model fit likelihood ratio test for A1C intervention trends was significant for 3 distinct non-linear trajectories ( P = .02 ) . CONCLUSIONS Conventional IE ( but not GE ) result ed in significant and sustained improvements in self-efficacy and reduced diabetes distress compared with UC , but short-term improvements in A1C , nutrition , and physical activity were not sustained . Patients may need ongoing reinforcement to achieve lasting behavioral change and glucose control",
"This study examines the effectiveness of a brief self-management intervention to support patients recently diagnosed with type-2 diabetes to achieve sustained improvements in their self-care behaviours . Based on proactive coping , the intervention emphasizes the crucial role of anticipation and planning in maintaining self-care behaviours . In a r and omised controlled trial among recent screen-detected patients , participants who received the intervention were compared with usual-care controls , examining changes in proximal outcomes ( intentions , self-efficacy and proactive coping ) , self-care behaviour ( diet , physical activity and medication ) and weight over time ( 0 , 3 and 12 months ) . Subsequently , the contribution of proactive coping in predicting maintenance of behavioural change was analysed using stepwise hierarchical regression analyses , controlling for baseline self-care behaviour , patient characteristics , and intentions and self-efficacy as measured after the course . The intervention was effective in improving proximal outcomes and behaviour with regard to diet and physical activity , result ing in significant weight loss at 12 months . Furthermore , proactive coping was a better predictor of long-term self-management than either intentions or self-efficacy . Proactive coping thus offers new insights into behavioural maintenance theory and can be used to develop effective self-management interventions ",
"It has been suggested that much effort expended in teaching diabetic diets is ineffective and wasteful . We have tested a different system by r and omly allocating 75 newly diagnosed obese Type 2 diabetic patients to usual ‘ unstructured ’ clinic care or to group education by diabetes specialist nurses and a dietitian . Patients allocated to group education attended five 90‐min group sessions during the first 6 months . Six months after diagnosis they had lost more weight ( median ( 95 % CI ) , 7 ( 5.5–9 ) vs 2 ( 1–5 ) kg , p were better controlled ( HbA1 : 7.5 ( 7.0–8.1 ) vs 9.5 ( 8.7–10.4 ) % , p the difference in weight loss was less ( 5.5 ( 4–6.5 ) vs 3 ( 2–4 ) kg , p had a fasting blood glucose less than 7.0 mmol l−1",
"ABSTRACT Background Several trials have demonstrated the efficacy of nurse telephone case management for diabetes ( DM ) and hypertension ( HTN ) in academic or vertically integrated systems . Little is known about the real-world potency of these interventions . Objective To assess the effectiveness of nurse behavioral management of DM and HTN in community practice s among patients with both diseases . Design The study was design ed as a patient-level r and omized controlled trial . Participants Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practice s. Subjects were required to have inadequately controlled DM ( hemoglobin A1c [ A1c ] ≥ 7.5 % ) but could have well-controlled HTN . Interventions All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years , for a total of 12 calls . Intervention patients received tailored DM- and HTN- focused behavioral content ; control patients received non-tailored , non-interactive information regarding health issues unrelated to DM and HTN ( e.g. , skin cancer prevention).Main Outcomes and Measures Systolic blood pressure ( SBP ) and A1c were co- primary outcomes , measured at 6 , 12 , and 24 months ; 24 months was the primary time point . Results Three hundred seventy-seven subjects were enrolled ; 193 were r and omized to intervention , 184 to control . Subjects were 55 % female and 50 % white ; the mean baseline A1c was 9.1 % ( SD = 1 % ) and mean SBP was 142 mmHg ( SD = 20 ) . Eighty-two percent of scheduled interviews were conducted ; 69 % of intervention patients and 70 % of control patients reached the 24-month time point . Expressing model estimated differences as ( intervention – control ) , at 24 months , intervention patients had similar A1c [ diff = 0.1 % , 95 % CI ( −0.3 , 0.5 ) , p = 0.51 ] and SBP [ diff = −0.9 mmH g , 95 % CI ( −5.4 , 3.5 ) , p = 0.68 ] values compared to control patients . Likewise , DBP ( diff = 0.4 mmHg , p = 0.76 ) , weight ( diff = 0.3 kg , p = 0.80 ) , and physical activity levels ( diff = 153 MET-min/week , p = 0.41 ) were similar between control and intervention patients . Results were also similar at the 6- and 12-month time points . Conclusions In nine community fee-for-service practice s , telephonic nurse case management did not lead to improvement in A1c or SBP . Gains seen in telephonic behavioral self-management interventions in optimal setting s may not translate to the wider range of primary care setting",
"OBJECTIVES The objectives of the study were to investigate the effectiveness of 2 types of peer-led self-management programs in bringing about improvements in subjects with type 2 diabetes mellitus and to determine whether there were differences in effectiveness between the 2 programs . METHODS The study used a 3-arm r and omized controlled trial design with clinical measures taken at baseline and at 6 and 12 months post-program . In total , 405 persons completed baseline question naires and were r and omly allocated to a diabetes self-management program ( n=130 ) , to a general self-management program ( n=109 ) or to a control group ( n=122 ) . A 2-way factorial analyses of variance was employed as the primary statistical analysis . RESULTS The findings showed that the self-management programs had affected 5 of the 30 measures : fatigue , cognitive symptom management , self-efficacy with regard to the disease in general , communication with physician , and the score on the Diabetes Empowerment Scale . In addition , 3 variables-social role limitations , total hospital nights and glycated hemoglobin levels-showed marginally significant interaction effects . The second analysis found similar results , with 4 of the 5 measures remaining statistically significant : fatigue , cognitive symptom management , communication with physician and diabetes empowerment , with neither program being more effective than the other . CONCLUSIONS The major findings are that although both programs were effective in bringing about positive changes in the outcome measures , there was little difference in effectiveness between the Diabetes Self-Management Program and the Chronic Disease Self-Management Program . This finding is consistent with the principle that behaviour-change strategies using self-efficacy are key components in health education programs",
"BACKGROUND Achievement of diabetes care goals is suboptimal globally . Diabetes-focused quality improvement ( QI ) is effective but remains untested in South Asia . OBJECTIVE To compare the effect of a multicomponent QI strategy versus usual care on cardiometabolic profiles in patients with poorly controlled diabetes . DESIGN Parallel , open-label , pragmatic r and omized , controlled trial . ( Clinical Trials.gov : NCT01212328 ) . SETTING Diabetes clinics in India and Pakistan . PATIENTS 1146 patients ( 575 in the intervention group and 571 in the usual care group ) with type 2 diabetes and poor cardiometabolic profiles ( glycated hemoglobin [ HbA1c ] level ≥8 % plus systolic blood pressure [ BP ] ≥140 mm Hg and /or low-density lipoprotein cholesterol [ LDLc ] level ≥130 mg/dL ) . INTERVENTION Multicomponent QI strategy comprising nonphysician care coordinators and decision-support electronic health records . MEASUREMENTS Proportions achieving HbA1c level less than 7 % plus BP less than 130/80 mm Hg and /or LDLc level less than 100 mg/dL ( primary outcome ) ; mean risk factor reductions , health-related quality of life ( HRQL ) , and treatment satisfaction ( secondary outcomes ) . RESULTS Baseline characteristics were similar between groups . Median diabetes duration was 7.0 years ; 6.8 % and 39.4 % of participants had preexisting cardiovascular and microvascular disease , respectively ; mean HbA1c level was 9.9 % ; mean BP was 143.3/81.7 mm Hg ; and mean LDLc level was 122.4 mg/dL. Over a median of 28 months , a greater percentage of intervention participants achieved the primary outcome ( 18.2 % vs. 8.1 % ; relative risk , 2.24 [ 95 % CI , 1.71 to 2.92 ] ) . Compared with usual care , intervention participants achieved larger reductions in HbA1c level ( -0.50 % [ CI , -0.69 % to -0.32 % ] ) , systolic BP ( -4.04 mm Hg [ CI , -5.85 to -2.22 mm Hg ] ) , diastolic BP ( -2.03 mm Hg [ CI , -3.00 to -1.05 mm Hg ] ) , and LDLc level ( -7.86 mg/dL [ CI , -10.90 to -4.81 mg/dL ] ) and reported higher HRQL and treatment satisfaction . LIMITATION Findings were confined to urban specialist diabetes clinics . CONCLUSION Multicomponent QI improves achievement of diabetes care goals , even in re source -challenged clinics . PRIMARY FUNDING SOURCE National Heart , Lung , and Blood Institute and UnitedHealth Group",
"OBJECTIVE To determine the effectiveness of specialist nurse-led clinics for hypertension and hyperlipidemia provided for diabetic patients receiving hospital-based care . RESEARCH DESIGN AND METHODS This study was a r and omized controlled implementation trial at Hope Hospital , Salford , U.K. The subjects consisted of 1,407 subjects presenting for annual review with raised blood pressure(>or=140/80 mmHg ) , raised total cholesterol ( > or=5.0 mmol/l ) , or both . Individuals with diabetes were r and omized to usual care or usual care with subsequent invitation to attend specialist nurse-led clinics . Nurses provided clinics for participants , with attendance every 4 - 6 weeks , until targets were achieved . Lifestyle advice and titration of drug therapies were provided according to the locally agreed upon guidelines . Patients with both conditions were eligible for enrollment in either or both clinics . At subsequent annual review , blood pressure and total cholesterol values were obtained from the Salford electronic diabetes register . Data relating to deaths were obtained from the national strategic tracing service . The primary outcome was the odds ratio of achieving targets in hypertension and hyperlipidemia , attributable to the specialist nurse-led intervention . RESULTS Overall , specialist nurse-led clinics were associated with a significant improvement in patients achieving the target after 1 year ( odds ratio [ OR ] 1.37 [ 95 % CI 1.11 - 1.69 ] , P = 0.003 ) . This primary analysis revealed a borderline difference in effect between the two types of clinics ( test for interaction between groups : P = 0.06 ) . Secondary analysis , consistent with the prior beliefs of the health care professionals involved , suggested that targets were achieved more frequently in patients enrolled in the specialist nurse-led clinic for hyperlipidemia ( OR 1.69 [ 1.25 - 2.29 ] , P = 0.0007 ) than for hypertension ( OR 1.14 [ 0.86 - 1.51 ] , P = 0.37 ) . Intervention ( enrolled to either or both clinics ) was associated with a reduction in all-cause mortality ( OR 0.55 [ 0.32 - 0.92 ] , P = 0.02 ) . CONCLUSIONS This study provides good evidence to support the use of specialist nurse-led clinics as an effective adjunct to hospital-based care of patients with diabetes . If the st and ards of care recommended in the National Service Framework for Diabetes are to be achieved , then such proven methods for delivering care must be adopted",
"Objective Poor metabolic control and high associated morbidity and mortality among type 2 diabetic patients require a level of care from the pharmacist that goes beyond usual dispensing . The aim of the present study was to evaluate the improvement in metabolic control , the resolution of drug-related problems ( DRPs ) and the increase in patient awareness of diabetes as outcomes of a pharmacotherapy follow-up program in type 2 diabetic patients . Method R and omized controlled trial conducted in 14 community pharmacies in the province of Pontevedra ( Spain ) with 112 patients between February 2003 and March 2004 . The control group received the usual care , and the intervention group patients were included in a pharmacotherapy follow-up program . This individualized program , which consists of the detection and resolution of DRPs and diabetes education , involves patients in their own care in order to obtain maximum benefit from the medication they use . Main outcome measures HbA1c , Fasting Blood Glucose ( FBG ) , lipid profile , blood pressure , body mass index ( BMI ) , DRPs and knowledge were evaluated at the onset of the program and periodically until conclusion . Results There was a significant difference in changes from baseline between the intervention and the control group in DRPs ( 1.7±1.2 versus 3.1±1.2 P ( 17.9±3.7 versus 11.4±6.7 points P ) , HbA1c ( 7.9±1.7 versus 8.5±1.9 % P ) , FBG ( 154±61.3 versus 168±57.8 mg/dl P=0.0004 ) , total cholesterol ( 202±41.5 versus 217±43.5 mg/dl P=0.0054 ) and SBP ( 135±16.4 versus 150±19.9 mmHg P=0.0006 ) . Conclusions A substantial number of patients showed an improvement in their outcomes for the chosen metabolic indicators . Pharmacotherapy follow-up programs conducted by community pharmacists can play an important role in achieving therapeutic goals in patients with type 2 diabetes . This study shows that the incorporation of type 2 diabetic patients in a pharmacotherapy follow-up program may contribute to achieve positive clinical outcomes and will contribute to the implementation and progress of pharmacotherapy follow-up programs in community pharmacies",
"Few studies have demonstrated an effect of educational interventions on glycaemic control in persons with Type 2 diabetes longer than 3 - 6 months after baseline . We aim ed to investigate the effectiveness of an experience-based group educational programme 24 months after baseline and to pinpoint mediators that might play a role in achieving desired metabolic outcomes . We conducted a r and omised controlled trial inviting self-referred persons with Type 2 diabetes ( N=77 r and omised ) . The pharmacist-led , year-long intervention was based on participants ' experiences of glucose regulation during the monthly group discussion s. We measured HbA1c at 0 , 6 , 12 , and 24 months and a question naire was administered at baseline and final follow-up . Our findings indicated that participating in the intervention programme significantly decreased HbA1c by 0.4 % at 24 months after baseline . Initial HbA1c , satisfaction with own diabetes-related knowledge , and treatment were found directly related to glycaemic outcomes . The intervention group exercised more in order to lower blood-glucose levels and was also more able to predict current blood-glucose levels before measuring it . Experience-based group education was effective in decreasing participants ' HbA1c 1-year after completed intervention . Early effect of the intervention was followed by relapse after 12 months and a new , significant decrease at 24 months ; this dual course implies that follow-up of educational interventions should involve several consecutive measurements to capture possible late effects . Both biomedical and subjective factors played a role in accounting for the variance of HbA1c at 2-year follow-up after baseline",
"BACKGROUND Group medical clinics ( GMCs ) are widely used in the management of diabetes and hypertension , but data on their effectiveness are limited . OBJECTIVE To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00286741 ) SETTING 2 Veterans Affairs Medical Centers in North Carolina and Virginia . PATIENTS 239 patients with poorly controlled diabetes ( hemoglobin A(1c ) [ HbA(1c ) ] level > or = 7.5 % ) and hypertension ( systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg ) . INTERVENTION Patients were r and omly assigned within each center to either attend a GMC or receive usual care . Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist , a pharmacist , and a nurse or other certified diabetes educator . Each session included structured group interactions moderated by the educator . The pharmacist and physician adjusted medication to manage each patient 's HbA(1c ) level and blood pressure . MEASUREMENTS Hemoglobin A(1c ) level and systolic blood pressure , measured by blinded research personnel at baseline , study midpoint ( median , 6.8 months ) , and study completion ( median follow-up , 12.8 months ) . Linear mixed models , adjusted for clustering within GMCs , were used to compare HbA(1c ) levels and systolic blood pressure between the intervention and control groups . RESULTS Mean baseline systolic blood pressure and HbA(1c ) level were 152.9 mm Hg ( SD , 14.2 ) and 9.2 % ( SD , 1.4 ) , respectively . At the end of the study , mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group ( P = 0.011 by linear mixed model ) , whereas mean HbA(1c ) level improved by 0.8 % in the GMC group and 0.5 % in the usual care group ( P = 0.159 ) . LIMITATION Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention . CONCLUSION Group medical clinics are a potent strategy for improving blood pressure but not HbA(1c ) level in diabetic patients . PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs Health Services Research and Development Service",
"AIMS To determine whether tighter cardiovascular risk factor control with structured education in individuals with type 2 diabetes ( T2DM ) and microalbuminuria benefits cardiovascular risk factors . METHODS Participants from a multiethnic population , recruited from primary care and specialist clinics were r and omised to intensive intervention with structured patient ( DESMOND model ) education ( n=94 ) or usual care by own health professional ( n=95 ) . PRIMARY OUTCOME change in HbA1c at 18months . SECONDARY OUTCOMES changes in blood pressure ( BP ) , cholesterol , albuminuria , proportion reaching risk factor targets , modelled cardiovascular risk scores . RESULTS Mean ( SD ) age and diabetes duration of participants were 61.5 ( 10.5 ) and 11.5 ( 9.3 ) years , respectively . At 18months , intensive intervention showed significant improvements in HbA1c ( 7.1(1.0 ) vs. 7.8(1.4)% , p ( 129(16 ) vs. 139(17 ) mmHg , p BP ( 70(11 ) vs. 76(12 ) mmHg , p cholesterol ( 3.7(0.8 ) vs. 4.1(0.9 ) mmol/l , p=0.001 ) . Moderate and severe hypoglycaemia was 11.2 vs. 29.0 % ; p=0.001 and 0 vs. 6.3 % ; p=0.07 , respectively . More intensive participants achieved ≥3 risk factor targets with greater reductions in cardiovascular risk scores . CONCLUSIONS Intensive intervention showed greater improvements in metabolic control and cardiovascular risk profile with lower rates of moderate and severe hypoglycaemia . Intensive glycaemic interventions should be underpinned by structured education promoting self-management in T2DM",
"AIMS To study the effect of a target-driven telecoaching intervention on HbA1c and other modifiable risk factors in people with Type 2 diabetes . METHODS We conducted a r and omized controlled trial in patients receiving hypoglycaemic agents . The primary outcome was HbA1c level at 6 months in the entire sample and in a subgroup with HbA1c levels ≥ 53 mmol/mol ( 7 % ) at baseline . Secondary outcomes were HbA1c at 18 months ; total cholesterol , LDL , HDL , triglycerides , blood pressure , BMI and proportion of people who had achieved guideline -recommended targets at 6 and 18 months . RESULTS A total of 287 participants were r and omized to telecoaching and 287 to usual care . The mean ( sd ) baseline HbA1c level was 53 ( 11 ) mmol/mol [ 7.0 (1.0)% ] overall and 63 ( 10 ) mmol/mol [ 7.9 (0.9)% ] in the elevated HbA1c subgroup . At 6 months , the between-group differences in favour of telecoaching were : HbA1c -2 ( 95 % CI -4 ; -1 ) mmol/mol [ -0.2 ( 95 % CI -0.3;-0.1)% ; P=0.003 ] overall and -4 ( 95 % CI -7 ; -2 ) mmol/mol [ -0.4 ( 95 % CI -0.7 ; -0.2)% ; P=0.001 ] in the elevated HbA1c subgroup ; BMI -0.4 kg/m(2 ) ( 95 % CI -0.6 ; -0.1 ; P=0.003 ) ; total cholesterol -6 mg/dl ( 95 % CI -11 ; -1 , P=0.012 ) . The proportion of participants on target for the composite of HbA1c , LDL and blood pressure increased by 8.9 % in the intervention group and decreased by 1.3 % in the control group ( P=0.011 ) . At 18 months , the difference in HbA1c was : -2 ( 95 % CI -3;-0 ) mmol/mol [ -0.2 ( 95 % CI -0.3 ; -0.0)% ; P=0.046 ] overall and -4 ( -7 ; -1 ) mmol/mol [ -0.4 ( 95 % CI -0.7 ; -0.1)% ; P=0.023 ] in the elevated HbA1c subgroup . CONCLUSION Nurse-led telecoaching improved glycaemic control , total cholesterol levels and BMI in people with Type 2 diabetes . Twelve months after the intervention completion , there were sustained improvements in glycaemic control",
"PURPOSE We sought to evaluate the effect of automated telephone assessment and self-care education calls with nurse follow-up on the management of diabetes . SUBJECTS AND METHODS We enrolled 280 English- or Spanish-speaking adults with diabetes who were using hypoglycemic medications and who were treated in a county health care system . Patients were r and omly assigned to usual care or to receive an intervention that consisted of usual care plus bi-weekly automated assessment and self-care education calls with telephone follow-up by a nurse educator . Outcomes measured at 12 months included survey-reported self-care , perceived glycemic control , and symptoms , as well as glycosylated hemoglobin ( Hb A1c ) and serum glucose levels . RESULTS We collected follow-up data for 89 % of enrollees ( 248 patients ) . Compared with usual care patients , intervention patients reported more frequent glucose monitoring , foot inspection , and weight monitoring , and fewer problems with medication adherence ( all P -0.03 ) . Follow-up Hb A , , levels were 0.3 % lower in the intervention group ( P = 0.1 ) , and about twice as many intervention patients had Hb A1c levels within the normal range ( P = 0.04 ) . Serum glucose levels were 41 mg/dL lower among intervention patients than usual care patients ( P = 0.002 ) . Intervention patients also reported better glycemic control ( P = 0.005 ) and fewer diabetic symptoms ( P symptoms of hyperglycemia and hypoglycemia . CONCLUSIONS Automated calls with telephone nurse follow-up may be an effective strategy for improving self-care behavior and glycemic control , and for decreasing symptoms among vulnerable patients with diabetes",
"OBJECTIVE To evaluate the effects of insulin 30/70 twice daily or bedtime isophane ( NPH ) insulin plus continued sulfonylurea and metformin in patients with type 2 diabetes in primary care . STUDY DESIGN Open-label , r and omized trial . POPULATION Persons younger than 76 years with type 2 diabetes whose disease had not been controlled with oral hypoglycemic agents alone . A total of 64 insulin-naive patients treated with maximal feasible dosages of sulfonylurea and metformin ( baseline glycosylated hemoglobin [HbA1c]=8.5 % ) were r and omly assigned to insulin monotherapy ( IM group ; n=31 ) or insulin in addition to unchanged oral hypoglycemic medication ( IC group ; n=33 ) for 12 months . Insulin doses were adjusted to obtain fasting glucose HbA1c , treatment failure , weight , hypoglycemic events and symptoms , satisfaction with treatment , general well-being , and fear of injecting insulin and testing . RESULTS HbA1c improved from 8.3 % to 7.6 % in the IC group , and from 8.8 % to 7.6 % in the IM group ( P = NS ) . The IC group had 24 % treatment failures , compared with 2 % in the IM group ( P=.09 ) . Patients in the IC group had less weight gain than those in the IM group ( 1.3 vs 4.2 kg ; P=.01 ) , and they reported fewer hypoglycemic events ( 2.7 vs 4.3 ; P=.02 ) . Increased satisfaction with treatment was equal in the 2 groups , and general well-being improved by 3.0 points more in the IC group ( P=.05 ) . Fear of self-injecting and self-testing did not differ . CONCLUSIONS Bedtime NPH insulin added to maximal therapy with sulfonylurea and metformin is an effective , simple , well-tolerated approach for patients with uncontrolled type 2 diabetes",
"Effects of a cognitive behavioural treatment ( CBT ) in type 2 diabetes patients were studied in a r and omised controlled trial . Patients were recruited from a diabetes care system ( DCS ) . The intervention group ( n = 76 ) received managed care from the DCS and CBT . The control group ( n = 78 ) received managed care only . Effects on risk of developing coronary heart disease ( CHD ) , clinical characteristics , lifestyle , determinants of behaviour change , quality of life , and depression were assessed after 6 and 12 months . The intervention did not result in a significant reduction of CHD risk ( difference between intervention and control group was −0.32 % ( 95 % CI : −2.27 ; 1.63 ) . The amount of heavy physical activity increased significantly in the intervention group at 6 months [ intervention versus control group was 20.14 min/day ( 95 % CI : 4.6 ; 35.70 ) ] . Quality of life and level of depression improved as well . All effects disappeared after 6 months . No effects were found on clinical characteristics ",
"BACKGROUND Increased emphasis is being placed on the critical need to control hypertension ( HTN ) in patients with diabetes . OBJECTIVE The objective of this study was to evaluate the efficacy of a nurse-managed home telehealth intervention to improve outcomes in veterans with comorbid diabetes and HTN . DESIGN A single-center , r and omized , controlled clinical trial design comparing two remote monitoring intensity levels and usual care in patients with type 2 diabetes and HTN being treated in primary care was used . MEASUREMENTS Primary outcomes were hemoglobin A1c and systolic blood pressure ( SBP ) ; secondary outcome was adherence . RESULTS Intervention subjects experienced decreased A1c during the 6-month intervention period compared with the control group , but 6 months after the intervention was withdrawn , the intervention groups were comparable with the control group . For SBP , the high-intensity subjects had a significant decrease in SBP compared with the other groups at 6 months and this pattern was maintained at 12 months . Adherence improved over time for all groups , but there were no differences among the three groups . LIMITATIONS Subjects had relatively good baseline control for A1c and SBP ; minorities and women were underrepresented . CONCLUSIONS Home telehealth provides an innovative and pragmatic approach to enhance earlier detection of key clinical symptoms requiring intervention . Transmission of education and advice to the patient on an ongoing basis with close surveillance by nurses can improve clinical outcomes in patients with comorbid chronic illness",
"OBJECTIVE This study evaluated the efficacy of a nurse-care management system design ed to improve outcomes in patients with complicated diabetes . RESEARCH DESIGN AND METHODS In this r and omized controlled trial that took place at Kaiser Permanente Medical Center in Santa Clara , CA , 169 patients with longst and ing diabetes , one or more major medical comorbid conditions , and HbA(lc ) > 10 % received a special intervention ( n = 84 ) or usual medical care ( n = 85 ) for 1 year . Patients met with a nurse-care manager to establish individual outcome goals , attended group sessions once a week for up to 4 weeks , and received telephone calls to manage medications and self-care activities . HbA(lc ) , LDL , HDL , and total cholesterol , triglycerides , fasting glucose , systolic and diastolic blood pressure , BMI , and psychosocial factors were measured at baseline and 1 year later . Annualized physician visits were determined for the year before and during the study . RESULTS At 1 year , the mean reductions in HbA(lc ) , total cholesterol , and LDL cholesterol were significantly greater for the intervention group compared with the usual care group . Significantly more patients in the intervention group met the goals for HbA(1c ) ( psychosocial variables or in physician visits . CONCLUSIONS A nurse-care management program can significantly improve some medical outcomes in patients with complicated diabetes without increasing physician visits",
"OBJECTIVE To study differences in diabetes-related parameters in type 2 diabetic patients treated with the support of a Diabetes Service compared to conventional general practice care . DESIGN Parallel clinical trial with r and omisation at practice level . SETTING Fifteen general practice s. PATIENTS Type 2 diabetic patients , aged MAIN OUTCOME MEASURES Level of glycated haemoglobin ( HbA1c ) . RESULTS 246 patients entered the study . Final mean HbA1c of all evaluable patients allocated to the intervention ( n = 84 ) was 7.1+/-1.2 % , vs 7.5+/-1.8 % in the controls ( n = 140 ) ( p = 0.06 ) . Patients who were initially poorly controlled ( Fasting Blood Glucose > 10 mmol/l ) had a significantly lower final HbA1c if they were in an intervention practice ( p=0.001 ) . Fewer patients in intervention practice s were referred to hospital specialists ( 1 vs 14 ) . CONCLUSIONS Support by the Dutch Diabetes Service did not significantly influence glycated haemoglobin . The subgroup of initially poorly controlled patients developed a significantly lower HbA1c in intervention practice s ( supported by a Diabetes Service ) than in control practice ",
"Objectives This r and omized controlled trial investigated whether a patient-centered supportive counseling intervention comprising monthly telephone-based counseling sessions by practice nurses over 12 months improved diabetes-related medical and psycho-social outcomes above usual care in type 2 diabetes patients with poor glycemic control at baseline ( HbA1c > 7.5 % ) in a primary care setting . Research Design Patients were individually r and omized into intervention ( n = 103 ) and usual care group ( n = 101 ) . The primary outcome was change in HbA1c-concentration after 12 and 18 months . Secondary outcomes were lipid levels , blood pressure , health-related quality of life and symptoms of depression . Follow-up- measurements were carried out after 6 , 12 and 18 months to assess potential immediate and maintained effects of the intervention . For the multivariate analysis , hierarchical linear models were computed for each outcome to assess within-group changes in outcomes over time and between-group differences in patterns of change . Results HbA1c ( in % ) decreased significantly from baseline to 12-month follow-up measurement both in the intervention ( −0.44 ) and the usual care group ( −0.51 ) , but there was no significant between-group intervention effect . Significant improvements in the intervention group along with significant between-group differences were seen for health-related quality of life and , transiently , for systolic blood pressure and depression . Conclusions Although we found no beneficial effect of the supportive telephone counseling in terms of a reduction of HbA1c above usual care , our findings suggest some beneficial effects on cardiovascular risk factors , quality of life and depression . Continuous efforts might be needed to sustain improvements in patient outcomes . Trial Registration Clinical Trials.gov",
"PURPOSE To assess the efficacy of a pharmacist-led , primary care-based , disease management program to improve cardiovascular risk factors and glycated hemoglobin ( A(1C ) ) levels in vulnerable patients with poorly controlled diabetes . METHODS A r and omized controlled trial of 217 patients with type 2 diabetes and poor glycemic control ( A(1C ) level > or=8.0 % ) was conducted at an academic general medicine practice from February 2001 to April 2003 . Intervention patients received intensive management from clinical pharmacists , as well as from a diabetes care coordinator who provided diabetes education , applied algorithms for managing glucose control and decreasing cardiovascular risk factors , and addressed barriers to care . Control patients received a one-time management session from a pharmacist followed by usual care from their primary care provider . Outcomes were recorded at baseline and at 6 and 12 months . Primary outcomes included blood pressure , A(1C ) level , cholesterol level , and aspirin use . Secondary outcomes included diabetes knowledge , satisfaction , use of clinical services , and adverse events . RESULTS For the 194 patients ( 89 % ) with 12-month data , the intervention group had significantly greater improvement than did the control group for systolic blood pressure ( -9 mm Hg ; 95 % confidence interval [ CI ] : -16 to -3 mm Hg ) and A(1C ) level ( -0.8 % ; 95 % CI : -1.7 % to 0 % ) . Change in total cholesterol level was not significant . At 12 months , aspirin use was 91 % in the intervention group versus 58 % among controls ( P diabetes knowledge and satisfaction than did control patients . There were no significant differences in use of clinical services or adverse events . CONCLUSION Our comprehensive disease management program reduced cardiovascular risk factors and A(1C ) levels among vulnerable patients with type 2 diabetes and poor glycemic control",
"We examine whether one-to-one lifestyle counseling for non-insulin-treated diabetic out patients by a Certified Expert Nurse ( CEN ) can improve patients ' health outcomes . Participants were r and omly assigned to a 1-year lifestyle intervention ( n=67 ) or to a usual care group ( n=67 ) . Main outcome measures were changes from baseline in : HbA(1C ) and score of health related quality of life scales ( SF-36 and Problem Areas in Diabetes Scale ) . Cognitive/behavioral modification for 1 year and satisfaction in CEN counseling was also measured by self-produced items . We found no significant differences in HbA(1C ) , BMI , blood pressure , serum lipids , or health related quality of life over 1 year between the two groups . Patients in the intervention group , however , showed modest but more favorable modification of cognition ( p=0.004 ) and behavior ( p attrition rate ( 9 % ) , more frequent hospital visit ( 12+/-2 times versus 11+/-3 times ; p=0.03 ) and high degree of satisfaction ( 95 % ) in the intervention group indicate feasibility of the monthly CEN counseling in the outpatient setting s of Japanese hospitals . Future research should confirm the long-term effectiveness of the CEN counseling on clinical outcomes and the cost effectiveness of a possibly time-consuming intervention",
"Background This dual‐center , r and omized controlled trial aim ed to compare 2 types of intra‐abdominal drains after pancreatic resection and their effect on the development of pancreatic fistulae and postoperative complications . Methods Patients undergoing pancreatic resection were r and omized to receive either a closed‐suction drain or a closed , passive gravity drain . The primary endpoint was the rate of postoperative pancreatic fistula . A secondary endpoint was postoperative morbidity during follow‐up of 3 months . The planned sample size was 223 patients . Results A total of 294 patients were assessed for eligibility , 223 of whom were r and omly allocated . One patient was lost during follow‐up , and 111 patients in each group were analyzed . The rate of postoperative pancreatic fistula ( closed‐suction 43.2 % , passive 36.9 % , P = .47 ) and overall morbidity ( closed‐suction 51.4 % , passive 40.5 % , P = .43 ) were not different between the groups . We did not find any differences between the groups in reoperation rate ( P = .45 ) , readmission rate ( P = .27 ) , hospital stay ( P = .68 ) , or postoperative hemorrhage ( P = .11 ) . We found a significantly lesser amount of drain fluid in the passive gravity drains between the second and fifth postoperative days and also on the day of drain removal compared with closed‐suction drains . Conclusion The type of drain ( passive versus closed suction ) had no influence on the rate of postoperative pancreatic fistulae . The closed‐suction drains did not increase the rate of postoperative complications . We found that the passive gravity drains are more at risk for obstruction , whereas the closed‐suction drains kept their patency for greater duration"
] | 411626c6-06ff-11f0-808a-c43d1ab1c353 |
Background / Objectives : This systematic review and meta- analysis was performed to assess the effects of inulin-type fructans ( ITF ) on human blood lipids and glucose homeostasis associated with metabolic abnormalities , including dyslipidemia , overweight or obesity , and type-2 diabetes mellitus (T2DM).Subjects/ Methods : The MEDLINE , EMBASE and Cochrane Library data bases were systematic ally search ed for r and omized controlled trials ( RCTs ) before January 2016 . Human trials that investigated the effects of ITF supplementation on the lipid profile , fasting glucose and insulin were included using Review Manager 5.3 . Results : Twenty RCTs with 607 adult participants were included in this systematic review and meta- analysis . In the overall analysis , the supplementation of ITF reduced only the low density lipoprotein-cholesterol ( LDL-c ) ( mean difference ( MD ) : –0.15 ; 95 % confidence interval ( CI ) : –0.29 , –0.02 ; P=0.03 ) without affecting the other endpoints . Within the T2DM subgroup analysis , ITF supplementation was positively associated with a decreased fasting insulin concentration ( MD : –4.01 ; 95 % CI : –5.92 , –2.09 ; P increased high density lipoprotein-cholesterol ( HDL-c ) ( MD : 0.07 ; 95 % CI : 0 , 0.14 ; P=0.05 ) . Moreover , a reduced fasting glucose tendency was identified only in the T2DM subgroup ( MD : –0.42 ; 95 % CI : –0.90 , 0.06 ; P=0.09 ) . There was a potential publication bias , and few trials were available for the T2DM subgroup analysis . Conclusions : In summary , the use of ITF may have benefits for LDL-c reduction across all study population s , whereas HDL-c improvement and glucose control were demonstrated only in the T2DM subgroup . Thus , additional , well-powered , long-term , r and omized clinical trials are required for a definitive conclusion . Overall , ITF supplementation may provide a novel direction for improving the lipid profile and glucose metabolism | [
"Objective To highlight the contribution of the gut microbiota to the modulation of host metabolism by dietary inulin-type fructans ( ITF prebiotics ) in obese women . Methods A double blind , placebo controlled , intervention study was performed with 30 obese women treated with ITF prebiotics ( inulin/oligofructose 50/50 mix ; n=15 ) or placebo ( maltodextrin ; n=15 ) for 3 months ( 16 g/day ) . Blood , faeces and urine sampling , oral glucose tolerance test , homeostasis model assessment and impedancemetry were performed before and after treatment . The gut microbial composition in faeces was analysed by phylogenetic microarray and qPCR analysis of 16S rDNA . Plasma and urine metabolic profiles were analysed by 1H-NMR spectroscopy . Results Treatment with ITF prebiotics , but not the placebo , led to an increase in Bifidobacterium and Faecalibacterium prausnitzii ; both bacteria negatively correlated with serum lipopolysaccharide levels . ITF prebiotics also decreased Bacteroides intestinalis , Bacteroides vulgatus and Propionibacterium , an effect associated with a slight decrease in fat mass and with plasma lactate and phosphatidylcholine levels . No clear treatment clustering could be detected for gut microbial analysis or plasma and urine metabolomic profile analyses . However , ITF prebiotics led to subtle changes in the gut microbiota that may importantly impact on several key metabolites implicated in obesity and /or diabetes . Conclusions ITF prebiotics selectively changed the gut microbiota composition in obese women , leading to modest changes in host metabolism , as suggested by the correlation between some bacterial species and metabolic endotoxaemia or metabolomic signatures",
"Abstract Background and aims Freeze-dried powdered yacon ( FDY ) can be considered a prebiotic product due to its fructooligosaccharides ( FOS ) content . The effect of 9 weeks of daily intake of FDY containing 7.4 g of FOS on glucose , lipid metabolism and intestinal transit in a group of elderly people was investigated . Methods Seventy-two elderly ( mean age 67.11 ± 6.11 ) men and women were studied for 9 weeks in a double-blind , placebo-controlled experiment . They were r and omly assigned to the supplement group ( which received 7.4 g of FOS as FDY ) or the control group . At the beginning and end of the study , anthropometric measurements , blood sampling , clinical analyses and dietary intake were assessed . Results A daily intake of FDY containing 7.4 g of FOS for 9 weeks was associated with a mean decrease in serum glucose ( p = 0.013 ) , but supplementation did not reduce serum lipids in the study group . The administered dose did not adversely affect intestinal transit . It did not cause bloating , flatulence or intestinal discomfort . Conclusion Freeze-dried powdered yacon is a good source of FOS , and daily consumption can have a favourable effect on serum glucose in the elderly . It is also practical , easy and safe to use and store",
"The primary aim of this study was to estimate the relation between cholesterol reduction and total mortality and coronary heart disease ( CHD ) incidence . Secondarily , the clinical issues of whether the efficacy of cholesterol lowering is dependent on the treatment modality , presence of CHD at baseline , or the simultaneous introduction of other interventions was explored . All r and omized clinical intervention trials of cholesterol reduction were used in an overview analysis of total mortality rate and CHD incidence ; analysis was performed with weighted linear regression . The trials include those that used primary and secondary intervention , diet and drugs , and single or multifactor design . Nineteen trials were analyzed for total mortality , and of the 19 , 16 were analyzed for CHD incidence rate . Net difference in cholesterol change between study groups was used as the independent variable , and the three previously mentioned dichotomous design characteristics were used as additional independent variables . For every 1 % reduction in cholesterol , an estimated 2.5 % reduction in CHD incidence is indicated ( 95 % CL : 1.1 , 3.9 ) . With regard to CHD drug trials tended toward better efficiency in cholesterol lowering than did dietary trials . With regard to total mortality , this efficiency was higher in secondary than in primary preventive trials . The efficiency was also somewhat dependent on the baseline cholesterol level . This study shows that cholesterol reduction is effective in lowering CHD incidence , but cholesterol reduction must be at least 8 - 9 % to be effective in lowering total mortality",
"BACKGROUND Experimental studies suggest that gut microbiota deviations predispose toward energy storage and obesity . OBJECTIVE We wanted to establish whether early gut microbiota composition can guide weight development throughout early childhood . DESIGN Overweight and obese children ( n = 25 ) were selected from a prospect i ve follow-up study at the age of 7 y and identified according to the International Obesity Task Force criteria . Normal-weight children ( n = 24 ) were selected from the same cohort and matched for gestational age and body mass index at birth , mode of delivery , probiotic supplementation , duration of breastfeeding , use of antibiotics during infancy , and frequencies of atopic diseases and atopic sensitization . Early fecal microbiota composition was analyzed by fluorescent in situ hybridization ( FISH ) with microscopic and flow cytometry detection and by quantitative real-time polymerase chain reaction ( qRT-PCR ) . RESULTS The bifidobacterial numbers in fecal sample s during infancy , as assessed by the FISH with flow cytometry , were higher in children remaining normal weight , [ median : 2.19 x 10(9 ) cells/g ( interquartile range : 1.10 - 5.28 x 10(9 ) cells/g ) ] than in children becoming overweight [ 1.20 x 10(9 ) cells/g ( 0.48 - 1.59x 10(9 ) cells/g ) ; P = 0.02 ] . A similar tendency was found by FISH with microscopic detection and qRT-PCR . The microbiota aberrancy during infancy in children becoming overweight was also associated with a greater number of Staphylococcus aureus [ 0.64 x 10(6 ) cells/g ( 0.33 - 1.00 x 10(6 ) cells/g ) ] than in children remaining normal weight [ 0.27 x 10(6 ) cells/g ( 0.17 - 0.50 x 10(6 ) cells/g ) ; P = 0.013 ] . CONCLUSION Aberrant compositional development of the gut microbiota precedes overweight , offering new possibilities for preventive and therapeutic applications in weight management",
"BACKGROUND A high-carbohydrate , low-fat diet is recommended for the prevention of atherosclerosis , because it reduces plasma cholesterol concentrations . However , such a diet can increase plasma triacylglycerol concentrations -- an undesirable side effect . The addition of nondigestible carbohydrate could reduce the risk of elevated triacylglycerol concentrations . OBJECTIVE The objective was to determine whether the addition of a moderate dose of inulin to a moderately high-carbohydrate diet would decrease hepatic lipogenesis and plasma triacylglycerol concentrations and have a cholesterol-lowering action . DESIGN Eight healthy subjects were studied twice in a double-blind , r and omized , placebo-controlled crossover study after consuming for 3 wk a moderately high-carbohydrate , low-fat diet ( 55 % of total energy ) plus an oral placebo or 10 g high-performance inulin/d . Hepatic lipogenesis and cholesterol synthesis ( deuterated water method ) , plasma lipid concentrations , fatty acid synthase , acetyl-CoA carboxylase 1 , and sterol responsive element binding protein 1c messenger RNA concentrations were measured in adipose tissue at the end of the 2 diet periods . RESULTS Plasma triacylglycerol concentrations and hepatic lipogenesis were lower after inulin than after placebo ingestion ( P cholesterol synthesis and plasma cholesterol concentrations were not significantly different between the 2 groups . None of the adipose tissue messenger RNA concentrations changed significantly after inulin ingestion . CONCLUSIONS The addition of high-performance inulin to a moderately high-carbohydrate , low-fat diet has a beneficial effect on plasma lipids by decreasing hepatic lipogenesis and plasma triacylglycerol concentrations . These results support the use of nondigestible carbohydrate for reducing risk factors for atherosclerosis",
"BACKGROUND Fructooligosaccharides have been cl aim ed to lower fasting glycemia and serum total cholesterol concentrations , possibly via effects of short-chain fatty acids produced during fermentation . OBJECTIVE We studied the effects of fructooligosaccharides on blood glucose , serum lipids , and serum acetate in 20 patients with type 2 diabetes . DESIGN In a r and omized , single-blind , crossover design , patients consumed either glucose as a placebo ( 4 g/d ) or fructooligosaccharides ( 15 g/d ) for 20 d each . Average daily intakes of energy , macronutrients , and dietary fiber were similar with both treatments . RESULTS Compliance , expressed as the proportion of supplements not returned , was near 100 % during both treatments . Fructooligosaccharides did not significantly affect fasting concentrations ( mmol/L ) of serum total cholesterol ( 95 % CI : -0.07 , 0.48 ) , HDL cholesterol ( -0.04 , 0.04 ) , LDL cholesterol ( -0.06 , 0.34 ) , serum triacylglycerols ( -0.21 , 0.44 ) , serum free fatty acids ( -0.08 , 0.04 ) , serum acetate ( -0.01 , 0.01 ) , or blood glucose ( -0.37 , 0.40 ) . CONCLUSIONS We conclude that 20 d of dietary supplementation with fructooligosaccharides had no major effect on blood glucose , serum lipids , or serum acetate in patients with type 2 diabetes . This lack of effect was not due to changes in dietary intake , insufficient statistical power , or noncompliance of the patients",
"Short-chain fructooligosaccharides ( FOS ) are prebiotics , which escape digestion in the small intestine and are fermented by the colonic microflora into short-chain fatty acids . Recently , we found that the daily consumption of 20 g FOS decreased basal hepatic glucose production in healthy subjects without any effect on insulin-stimulated glucose metabolism . In this study , we evaluated the effects of the chronic ingestion of FOS on plasma lipid and glucose concentrations , hepatic glucose production and insulin resistance in type 2 diabetics . Type 2 diabetic volunteers ( n = 10 ; 6 men , 4 women ) received either 20 g/d FOS or sucrose for 4 wk in a double-blind crossover design . FOS did not modify fasting plasma glucose and insulin concentrations or basal hepatic glucose production . The plasma glucose response to a fixed exogenous insulin bolus did not differ at the end of the two periods . Erythrocyte insulin binding also did not differ . Serum triacylglycerol , total and HDL cholesterol , free fatty acid , apolipoproteins A1 and B and lipoprotein ( a ) concentrations were not modified by the chronic ingestion of FOS . We conclude that 4 wk of 20 g/d of FOS had no effect on glucose and lipid metabolism in type 2 diabetics",
"Background Inulin has been suggested to have beneficial effects on lipids , especially on triglyceridemia . Few data are available about the effects of inulin on Lipoprotein(a ) , a low-density lipoprotein-like particle considered as an independent risk factor for atherosclerosis . Adding inulin to pasta could be a preventive strategy for delaying the onset of atherosclerosis . Aim of the study was to evaluate the effects of inulin-enriched pasta on lipid profile and on Lipoprotein(a ) in young healthy subjects . Methods Twenty-two young healthy male volunteers entered a r and omized double blind cross-over study consisting of a 2-weeks run-in period , a baseline assessment , two 5-weeks study periods ( 11 % inulin-enriched or control pasta ) , and an 8-weeks wash-out period in between . Serum lipid concentrations were evaluated by routine biochemical analyses and plasma Lipoprotein(a ) concentrations by ELISA . The size of apolipoprotein(a ) isoforms was determined by Western blot and immunodetection . Results Significant differences at baseline and in the treatment groups were found for HDL-cholesterol ( P = 0.004 ) , total cholesterol/HDL-cholesterol ratio ( P = 0.006 ) , triglycerides ( P = 0.04 ) , and Lipoprotein(a ) ( P = 0.02 ) concentrations ( data analyzed by Friedman test ) . Dunn ’s multiple comparison test was used to assess the significance of differences between inulin-enriched pasta diet vs. baseline . HDL-cholesterol concentrations increased by 35.9 % ; total cholesterol/HDL-cholesterol ratio , triglycerides , and Lipoprotein(a ) concentrations decreased by 22.2 , 23.4 , and 16.5 % respectively . Conclusions Inulin-enriched pasta administration induced significant effects on lipid pattern parameters in young healthy volunteers , including a significant reduction in Lipoprotein(a ) concentrations",
"It is thought that diets high in dietary fibre are associated with reduced risk for type 2 diabetes , at least in part because the short-chain fatty acids ( SCFAs ) produced during the colonic fermentation of fibre beneficially influence circulating concentrations of free-fatty acids ( FFAs ) and gut hormones involved in the regulation of blood glucose and body mass . However , there is a paucity of data showing this sequence of events in humans . Thus , our objective was to determine the effect of the fermentable fibre inulin on postpr and ial glucose , insulin , SCFA , FFA , and gut hormone responses in healthy subjects . Overnight fasted healthy subjects ( n = 12 ) were studied for 6 h after consuming 400 mL drinks , containing 80 g high-fructose corn syrup ( 80HFCS ) , 56 g HFCS ( 56HFCS ) , or 56 g HFCS plus 24 g inulin ( Inulin ) , using a r and omized , single-blind , crossover design . A st and ard lunch was served 4 h after the test drink . Glucose and insulin responses after Inulin did not differ significantly from those after 80HFCS or 56HFCS . Serum acetate , propionate , and butyrate were significantly higher after Inulin than after HFCS drinks from 4 - 6 h. FFAs fell at a similar rate after all 3 test drinks , but were lower after Inulin than after 56HFCS at 4 h ( 0.40 + /- 0.06 vs. 0.51 + /- 0.06 mmol*L-1 ; p Inulin significantly increased plasma glucagon-like peptide-1 concentrations at 30 min , and reduced ghrelin at 4.5 h and 6 h. The results are consistent with the hypothesis that dietary fibre increases the production of colonic SCFAs , which may reduce type 2 diabetes risk by reducing postpr and ial FFAs and favorably affecting gut hormones , which regulate food intake",
"The present study was carried out to examine the effect of the daily intake of 10 g inulin on fasting blood lipid , glucose and insulin levels in healthy middle-aged men and women with moderately raised total plasma cholesterol ( TC ) and triacylglycerol ( TAG ) levels . This study was a double-blind r and omized placebo-controlled parallel study in which fifty-four middle-aged subjects received either inulin or placebo for a period of 8 weeks . Fasting blood sample s were collected before the supplementation period ( baseline sample s 1 and 2 , separated by 1 week ) and at weeks 4 and 8 , with a follow-up at week 12 . Compared with baseline values , insulin concentrations were significantly lower at 4 weeks ( P TAG values , compared with baseline , to be lower in the inulin group at 8 weeks ( P inulin and placebo groups , the fasting TAG responses over the 8-week test period were shown to be significantly different ( P plasma TAG levels in the inulin group at week 8 . The percentage change in TAG levels in the inulin group during the 8-week study was shown to correlate with the initial TAG level of the subjects ( rs -0.499 , P = 0.004 ) . We therefore conclude that the daily addition of 10 g inulin to the diet significantly reduced fasting insulin concentrations during the 8-week test period and result ed in lower plasma TAG levels , particularly in subjects in whom fasting TAG levels were greater than 1.5 mmol/l . These data support findings from animal studies that fructans influence the formation and /or degradation of TAG-rich lipoprotein particles , and the insulin data are also consistent with recent studies showing attenuation of insulin levels in fructan-treated rats",
"Background Obesity is a major public health problem in many poor countries where micronutrient deficiencies are prevalent . A partial meal replacement may be an effective strategy to decrease obesity and increase micronutrient intake in such population s. The objective was to evaluate the efficacy of a partial meal replacement with and without inulin on weight reduction , blood lipids and micronutrients intake in obese Mexican women . Methods In a r and omized controlled clinical trial 144 women ( 18–50 y ) with BMI ≥ 25 kg/m2 , were allocated into one of the following treatments during 3 months : 1 ) Two doses/d of a partial meal replacement ( PMR ) , 2 ) Two doses/d of PMR with inulin ( PMR + I ) , 3 ) Two doses/d of 5 g of inulin ( INU ) and 4 ) Control group ( CON ) . All groups received a low calorie diet ( LCD ) . Weight , height , hip and waist circumference were measured every 2 weeks and body composition , lipids and glucose concentration and nutrient intake were assessed at baseline and after 3 months . Results All groups significantly reduced weight , BMI , waist and hip circumference . Differences between groups were only observed in BMI and weight adjusted changes : At 45 days PMR group lost more weight than INU and CON groups by 0.9 and 1.2Kg , respectively . At 60 days , PMR + I and PMR groups lost more weight than in INU by 0.7 and 1Kg , respectively . Subjects in PMR , PMR + I and INU significantly decreased triglycerides . Energy intake was reduced in all groups . Fiber intake increased in PMR + I and INU groups . Some minerals and vitamins intakes were higher in PMR and PMR + I compared with INU and CON groups . Conclusion Inclusion of PMR with and without inulin to a LCD had no additional effect on weight reduction than a LCD alone but reduced triglycerides and improved intake of micronutrients during caloric restriction . PMR could be a good alternative for obese population s with micronutrient deficiencies . Clinical Trials . Gov",
"INTRODUCTION It is essential to determine which snack foods are most affective for appetite control . The objective of the current study was to assess the responses of two different cookies on satiety and cardiovascular risk factors . MATERIAL AND METHODS 38 patients were r and omized : group I ( FOS enriched cookie , n=19 ) and group II ( control cookie , n=19 ) . Previous and after 1 month , the subjects rated their feelings of satiety/hunger with a test meal of 5 cookies . RESULTS After the test meal , the basal area under curve of the first hunger/satiety score was higher with satiety cookie than with control cookie , the data after 1 month of treatment was higher with satiety cookie than with control cookie , too . The score was higher than the fasting level for 20 minutes with satiety cookie and for 40 minutes with the same cookie , too . In satiety group , these scores ( 20 min and 40 min ) were higher than control group before and after 1 month of treatment . The results were in the same way with the 100 mm 5-point visual satiety scale . Cardiovascular risk factors and dietary intake remained unchanged after dietary intervention . CONCLUSION A FOS enriched cookie produced greater ratings of satiety than a control cookie , without effects on cardiovascular risk factors or dietary intakes",
"Solutions containing 90 mmol sodium acetate plus 30 mmol sodium propionate ( 90 mM ; isotonic ) , 180 mmol acetate plus 60 mmol propionate ( 180 mM ; hypertonic ) or an equivalent volume of isotonic saline were given over a 30-min period in r and om order by rectal infusion to six healthy subjects . Peripheral venous blood sample s were obtained at 30-min intervals over the next 2 h. After the 90 mM infusion , the serum acetate response reached a peak at 60 min and had fallen to baseline by 120 min . The incremental area under the serum acetate response curve after 180 mM was twice that after 90 mM. Propionate was undetectable in serum at any time . Blood glucose fell after all of the infusions , but there was no significant difference between the saline- and short chain fatty acid (SCFA)-containing infusions . SCFA had no significant effect on serum insulin or c-peptide concentrations . However , compared with the saline control , the 180 mM solution result ed in a significant fall in serum free-fatty acids ( FFA ) and a significant rise in serum total cholesterol and triglyceride , with no change in beta-hydroxybutyrate levels . The data provide strong evidence that colonic SCFA are absorbed and metabolized in the human subject . The fall in FFA suggests that colonic SCFA have an effect on carbohydrate metabolism . In addition , the data provide indirect evidence for utilization of SCFA for lipid synthesis",
"CONTEXT Combining foods with recognized cholesterol-lowering properties ( dietary portfolio ) has proven highly effective in lowering serum cholesterol under metabolically controlled conditions . OBJECTIVE To assess the effect of a dietary portfolio administered at 2 levels of intensity on percentage change in low-density lipoprotein cholesterol ( LDL-C ) among participants following self-selected diets . DESIGN , SETTING , AND PARTICIPANTS A parallel- design study of 351 participants with hyperlipidemia from 4 participating academic centers across Canada ( Quebec City , Toronto , Winnipeg , and Vancouver ) r and omized between June 25 , 2007 , and February 19 , 2009 , to 1 of 3 treatments lasting 6 months . INTERVENTION Participants received dietary advice for 6 months on either a low-saturated fat therapeutic diet ( control ) or a dietary portfolio , for which counseling was delivered at different frequencies , that emphasized dietary incorporation of plant sterols , soy protein , viscous fibers , and nuts . Routine dietary portfolio involved 2 clinic visits over 6 months and intensive dietary portfolio involved 7 clinic visits over 6 months . MAIN OUTCOME MEASURES Percentage change in serum LDL-C. RESULTS In the modified intention-to-treat analysis of 345 participants , the overall attrition rate was not significantly different between treatments ( 18 % for intensive dietary portfolio , 23 % for routine dietary portfolio , and 26 % for control ; Fisher exact test , P = .33 ) . The LDL-C reductions from an overall mean of 171 mg/dL ( 95 % confidence interval [ CI ] , 168 - 174 mg/dL ) were -13.8 % ( 95 % CI , -17.2 % to -10.3 % ; P dietary portfolio ; -13.1 % ( 95 % CI , -16.7 % to -9.5 % ; P Percentage LDL-C reductions for each dietary portfolio were significantly more than the control diet ( P 2 dietary portfolio interventions did not differ significantly ( P = .66 ) . Among participants r and omized to one of the dietary portfolio interventions , percentage reduction in LDL-C on the dietary portfolio was associated with dietary adherence ( r = -0.34 , n = 157 , P dietary portfolio compared with the low-saturated fat dietary advice result ed in greater LDL-C lowering during 6 months of follow-up . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00438425",
"OBJECTIVE To investigate the effect of nutrient stimulation of gut hormones by oligofructose supplementation on appetite , energy intake ( EI ) , body weight ( BW ) and adiposity in overweight and obese volunteers . METHODS In a parallel , single-blind and placebo-controlled study , 22 healthy overweight and obese volunteers were r and omly allocated to receive 30 g day(-1 ) oligofructose or cellulose for 6 weeks following a 2-week run-in . Subjective appetite and side effect scores , breath hydrogen , serum short chain fatty acids ( SCFAs ) , plasma gut hormones , glucose and insulin concentrations , EI , BW and adiposity were quantified at baseline and post-supplementation . RESULTS Oligofructose increased breath hydrogen ( P late acetate concentrations ( P = 0.024 ) , tended to increase total area under the curve (tAUC)420 mins peptide YY ( PYY ) ( P = 0.056 ) and reduced tAUC450 mins hunger ( P = 0.034 ) and motivation to eat ( P = 0.013 ) when compared with cellulose . However , there was no significant difference between the groups in other parameters although within group analyses showed an increase in glucagon-like peptide 1 ( GLP-1 ) ( P = 0.006 ) in the cellulose group and a decrease in EI during ad libitum meal in both groups . CONCLUSIONS Oligofructose increased plasma PYY concentrations and suppressed appetite , while cellulose increased GLP-1 concentrations . EI decreased in both groups . However , these positive effects did not translate into changes in BW or adiposity",
"BACKGROUND Type 2 diabetes mellitus , as a noncommunicable disease , is the main public health challenge in the 21st century . The prevalence of diabetes mellitus adjusted for the world population in Iran was 8 % until the year 2010.Lipid levels are considered as important parameters to be evaluated , as high serum lipid levels are often reported as a complication in patients with diabetes mellitus . It is cl aim ed that functional foods may improve complications of diabetes mellitus , so this study was design ed to evaluate the effects of high performance inulin on glycemic status and lipid profile of women with type 2 diabetes . METHODS The study was a r and omized controlled clinical trial . Forty-nine type 2 diabetic females ( fiber intake were divided into two groups . Patients in the intervention group ( n=24 ) received 10g/d inulin and patients in the control group ( n=25 ) received 10g/d maltodextrin for 8 weeks . Glycemic status and lipid profile indices were measured pre and post intervention . Data were analyzed using SPSS software ( verision11.5 ) . Paired , unpaired t-test and ANCOVA were used to compare quantitative variables . RESULTS Supplementation with inulin caused a significant reduction in FBS ( 8.50 % ) , HbA1c ( 10.40 % ) , total cholesterol ( 12.90 % ) , triglyceride ( 23.60 % ) , LDL-c ( 35.30 % ) , LDL-c/HDL-c ratio ( 16.25 % ) and TC/HDL-c ratio ( 25.20 % ) and increased HDL-c ( 19.90 % ) . The changes for the control group parameters were not significant at the end of study . CONCLUSION Inulin may help to control diabetes and its complications via improving glycemic and lipid parameters",
"The effect of a daily intake of 14 g inulin added to a low-fat spread on fasting blood lipids and gastrointestinal symptoms was investigated in sixty-four young healthy women in a r and omized double-blind crossover study involving two periods of 4 weeks . The test spread with and without inulin replaced habitual spread during the test periods . No significant differences between the test periods in plasma total cholesterol , HDL-cholesterol , LDL-cholesterol and triacylglycerol concentrations were observed . Gastrointestinal symptoms assessed with question naires showed that in the inulin period there was a significantly ( P degree of discomfort from flatulence and other gastrointestinal symptoms than in the control period . In general , there was no indication of intestinal adaptation to this level of intake of inulin",
"Objective : To study the effect of the intake of 15 g nondigestible oligosaccharides per day on various parameters of large-bowel function , as well as on blood lipid concentrations and glucose absorption in man . Design : Latin square , r and omized , double-blind , diet-controlled . Setting : Metabolic research unit . Subjects : Twelve apparently healthy men ( mean age 23 years ) , recruited from the Institute ’s pool of volunteers , no drop-outs . Interventions : Four treatment periods of 3 weeks : inulin , fructo-oligosaccharides ( FOS ) , galacto-oligosaccharides ( GOS ) and control ; analyses of stool weight , intestinal transit , faecal pH , short-chain fatty acids , bile acids , faecal enzymes , blood lipids and glucose absorption . Results : As compared to the control treatment : higher concentration of faecal acetate ( inulin and GOS , P and valerate ( inulin , P lower concentration of faecal deoxycholic acid ( inulin and FOS , P and β-glucuronidase activity ( inulin and GOS , P of faecal parameters and those of blood lipids and glucose absorption were statistically not significant . Conclusions : Results indicate that nondigestible oligosaccharides are ( partly ) fermented in the human colon , but in healthy young men the effects are limited . Also the consumption of 15 g nondigestible oligosaccharides does not seem to alter blood lipid concentrations and glucose absorption in our young healthy adults . Sponsorship : European Union and ORAFTI s.a . , Tienen , Belgium",
"Short-term studies have shown that the addition to diet of inulin-type fructans , a nondigestible carbohydrate , may have a plasma lipid-lowering effect in humans . Whether this beneficial effect persists during long-term administration has not been determined . The study was aim ed at determining whether a prolonged ( 6 months ) administration of inulin-type fructans to healthy subjects has a lipid-lowering action . In a double-blind , r and omized , placebo-controlled study , 17 healthy subjects were studied before and after 6 months of daily administration of placebo ( 8 subjects ) or 10 g of a mix of inulin and oligofructose ( 9 subjects ) . During this 6-month period , they consumed their usual diet and did not modify their everyday way of life . We measured plasma lipid concentrations ; cholesterol synthesis and hepatic lipogenesis ; and adipose tissue and circulating mononuclear cell messenger RNA concentrations of key regulatory genes of cholesterol metabolism . Compared with the administration of placebo , the administration of inulin-type fructans had no effect on plasma triacylglycerol concentrations and hepatic lipogenesis and induced only a nonsignificant trend for decreased plasma total and low-density lipoprotein cholesterol levels and increased high-density lipoprotein cholesterol concentration . Cholesterol synthesis was not significantly modified . Of all the messenger RNA concentrations measured , none was significantly modified by the administration of inulin-type fructans . In conclusion , contrary to what was observed in short-term studies , we observed no significant beneficial effect of a long-term ( 6-month ) administration of inulin-type fructans on plasma lipids in healthy human subjects",
"Complex gene – environment interactions are considered important in the development of obesity . The composition of the gut microbiota can determine the efficacy of energy harvest from food and changes in dietary composition have been associated with changes in the composition of gut microbial population s. The capacity to explore microbiota composition was markedly improved by the development of metagenomic approaches , which have already allowed production of the first human gut microbial gene catalogue and stratifying individuals by their gut genomic profile into different enterotypes , but the analyses were carried out mainly in non-intervention setting s. To investigate the temporal relationships between food intake , gut microbiota and metabolic and inflammatory phenotypes , we conducted diet-induced weight-loss and weight-stabilization interventions in a study sample of 38 obese and 11 overweight individuals . Here we report that individuals with reduced microbial gene richness ( 40 % ) present more pronounced dys-metabolism and low- grade inflammation , as observed concomitantly in the accompanying paper . Dietary intervention improves low gene richness and clinical phenotypes , but seems to be less efficient for inflammation variables in individuals with lower gene richness . Low gene richness may therefore have predictive potential for the efficacy of intervention",
"BACKGROUND Rodent studies show that oligofructose promotes weight loss , stimulates satiety hormone secretion , reduces energy intake , and improves lipid profiles . OBJECTIVE Our objective was to examine the effects of oligofructose supplementation on body weight and satiety hormone concentrations in overweight and obese adults . DESIGN This study was a r and omized , double-blind , placebo-controlled trial . Forty-eight otherwise healthy adults with a body mass index ( in kg/m2 ) > 25 were r and omly assigned to receive 21 g oligofructose/d or a placebo ( maltodextrin ) for 12 wk . Body composition ( by dual-energy X-ray absorptiometry ) ; meal tolerance tests , including satiety hormone response ; food intake ; and subjective appetite ratings were determined . RESULTS There was a reduction in body weight of 1.03 + /- 0.43 kg with oligofructose supplementation , whereas the control group experienced an increase in body weight of 0.45 + /- 0.31 kg over 12 wk ( P = 0.01 ) . A lower area under the curve ( AUC ) for ghrelin ( P = 0.004 ) and a higher AUC for peptide YY ( PYY ) with oligofructose ( P = 0.03 ) coincided with a reduction in self-reported caloric intake ( P Glucose decreased in the oligofructose group and increased in the control group between initial and final tests ( P Insulin concentrations mirrored this pattern ( P Oligofructose supplementation did not affect plasma active glucagon-like peptide 1 secretion . According to a visual analog scale design ed to assess side effects , oligofructose was well tolerated . CONCLUSIONS Independent of other lifestyle changes , oligofructose supplementation has the potential to promote weight loss and improve glucose regulation in overweight adults . Suppressed ghrelin and enhanced PYY may contribute in part to the reduction in energy intake . The trial was registered at clinical trials.gov as NCT00522353"
] | 41162702-06ff-11f0-808a-c43d1ab1c353 |
Atrial remodeling is a term introduced in 1995 to describe alterations in atrial structure or function . Atrial electrical remodeling is characterized by a reduction of refractory period and action potential duration , dispersion in refractoriness , and a reduction in conduction velocity of impulse propagation . Numerous animal and human studies have demonstrated that atrial electrical remodeling impairs normal atrial conduction and provides an environment for ectopic and re-entrant activity , thus creating a substrate for the initiation or maintenance of atrial fibrillation . Interestingly , atrial electrical remodeling has been shown to be reversible . In this systematic review , we examine the occurrence of reverse atrial electrical remodeling in various clinical setting | [
"Background —Atrial fibrillation ( AF ) frequently complicates congestive heart failure ( CHF ) . However , the electrophysiological substrate for AF in humans with CHF remains unknown . We evaluated the electrophysiological and electroanatomic characteristics of the atria in patients with CHF . Methods and Results —Twenty-one patients ( aged 53.7±13.6 years ) with symptomatic CHF ( left ventricular ejection fraction 25.5±6.0 % ) and 21 age-matched controls were studied . The following were evaluated : effective refractory periods ( ERPs ) from the high and low lateral right atrium ( LRA ) , high septal right atrium , and distal coronary sinus ( CS ) ; conduction time along the CS and LRA ; corrected sinus node recovery times ; P-wave duration ; and conduction at the crista terminalis . In a subset , electroanatomic mapping was performed to determine atrial activation , regional conduction velocity , double potentials , fractionated electrograms , regional voltage , and areas of electrical silence . Patients with CHF demonstrated an increase in atrial ERP with no change in the heterogeneity of refractoriness , an increase of atrial conduction time along the LRA and the CS , prolongation of the P-wave duration and corrected sinus node recovery times , and greater number and duration of double potentials along the crista terminalis . Electroanatomic mapping demonstrated regional conduction slowing with a greater number of electrograms with fractionation or double potentials , associated with areas of low voltage and electrical silence ( scar ) . Patients with CHF demonstrated an increased propensity for AF with single extrastimuli , and induced AF was more often sustained . Conclusions —Atrial remodeling due to CHF is characterized by structural changes , abnormalities of conduction , sinus node dysfunction , and increased refractoriness . These abnormalities may be responsible in part for the increased propensity for AF in CHF",
"INTRODUCTION Elucidating the functional properties and remodeling process of the entire left atrium ( LA ) is important not only for offering the mechanistic insight into atrial fibrillation ( AF ) but also for assessing the effectiveness of catheter ablation . METHODS We included 65 patients with paroxysmal AF and 29 controls . Baseline multidetector computed tomography ( MDCT ) was acquired in all subjects and a follow-up MDCT was available in 48 patients after pulmonary vein and LA ablation . The 3-dimensional images at atrial end-diastole ( ED ) and end-systole ( ES ) were analyzed . RESULTS The LA volume ( ED : 61.11 + /- 15.94 vs 54.12 + /- 8.94 mL/m(2 ) , P = 0.03 ; ES : 45.29 + /- 17.64 vs 33.38 + /- 7.78 mL/m(2 ) , P ejection fraction ( EF ) ( 26.93 + /- 13.40 vs 38.09 + /- 11.62 % , P ES LA volume ( 44.73 + /- 14.93 vs 38.04 + /- 11.51 mL/m(2 ) , P = 0.04 ) decreased and the LA EF ( 25.04 + /- 13.13 vs 30.82 + /- 7.85 % , P = 0.03 ) increased in patients without any AF recurrence . The wall motion ( WM ) analysis of the 18 segments of LA revealed increased motional magnitudes of entire LA except for the anterior roof . In contrast , the volume , EF , and WM of LA remained similar in patients with recurrence . CONCLUSION Dilated LA with global hypokinesia was noted in AF patients . Improved LA transport function was demonstrated in patients without any recurrence after ablation . However , the anatomic and functional reverse remodeling was not significant in patients with AF recurrence",
"INTRODUCTION In animals , atrial fibrillation results in reversible atrial electrical remodeling manifested as shortening of the atrial effective refractory period , slowing of intra-atrial conduction , and prolongation of sinus node recovery time . There is limited information on changes in these parameters after cardioversion in patients with persistent atrial fibrillation . METHODS AND RESULTS Thirty-eight patients who had been in atrial fibrillation for 1 to 12 months underwent electrophysiologic testing 10 minutes and 1 hour after cardioversion . At 1 week , 19 patients still in sinus rhythm returned for repeat testing . Reverse remodeling of the effective refractory period was not uniform across the three atrial sites tested . At the lateral right atrium , there was a highly significant increase in the effective refractory period between 10 minutes and 1 hour after cardioversion ( drive cycle length 400 ms : 204 + /- 17 ms vs 211 + /- 20 ms , drive cycle length 550 ms : 213 + /- 18 ms vs 219 + /- 23 ms , P effective refractory period at the coronary sinus and distal coronary sinus did not change in the first hour but had increased by 1 week . The corrected sinus node recovery time did not change in the first hour but was shorter at 1 week ( 606 + /- 311 ms vs 408 + /- 160 ms , P = 0.009 ) . P wave duration also was shorter at 1 week ( 135 + /- 18 ms vs 129 + /- 13 ms , P = 0.04 ) consistent with increasing atrial conduction velocity . CONCLUSION The atrial effective refractory period increases , sinus node function improves , and atrial conduction velocity goes up in the first week after cardioversion of long-st and ing atrial fibrillation in humans . Reverse electrical remodeling of the effective refractory period occurs at different rates in different regions of the atrium",
"BACKGROUND Cardiac resynchronization therapy ( CRT ) , which improves left ventricular ( LV ) function and reverses LV remodeling , is an established therapy for advanced heart failure with prolonged QRS duration . The aim of this study was to examine whether CRT improves atrial function and induces atrial reverse remodeling . METHODS A total of 46 patients with heart failure ( mean age , 66.7 + /- 10.4 years ) who underwent CRT were evaluated with echocardiography before and after 6 months of optimized CRT . Atrial function and LV function were assessed with M-mode , two-dimensional echocardiography , Doppler , tissue Doppler velocity , and strain ( epsilon ) imaging . LV reverse remodeling was defined as a reduction in LV end-systolic volume of > 15 % . RESULTS In responders ( n = 23 ) , significant improvements in left atrial ( LA ) functional , structural , and anatomic remodeling were observed . Maximum LA area and volume decreased , the LA emptying fraction increased , A ' increased , and LA epsilon increased from 25.6 + /- 11.0 % to 42.6 + /- 10.4 % ( P LA reverse remodeling was correlated with baseline LA volume ( R = 0.45 ) . Although the correlation was not significant ( r = 0.24 ) , LA reverse remodeling was also more frequent in patients with LV reverse remodeling . CONCLUSIONS In patients with LV remodeling , significant LA reverse remodeling after CRT could be observed and detailed on transthoracic echocardiography",
"In an attempt to define quantitatively the relation between left atrial size and atrial fibrillation , echocardiography was used to study 85 patients with isolated mitral valve disease , 50 patients with isolated aortic valve disease , and 130 patients with asymmetric septal hypertrophy . In all three groups of patients , atrial fibrillation was rare when left atrial dimension was below 40 mm ( 3 of 117 or 3 % ) but common when this dimension exceeded 40 mm ( 80 of 148 or 54 % ) . In addition , when left atrial dimension exceeds 45 mm , cardioversion , while initially successful , is unlikely to produce sinus rhythm that can be maintained at least six months . These data suggest that left atrial size is an important factor in the development of atrial fibrillation and in determining the long term result of cardioversion . The pathophysiologic mechanism most consistent with this is that a chronic hemodynamic burden initially produces left atrial enlargement which in turn predisposes to atrial fibrillation . Only prospect i ve studies will determine definitively whether these observations will be useful in decisions concerning prophylactic anticoagulation and elective cardioversion",
"OBJECTIVES This study was design ed to determine whether the signal-averaged electrocardiogram of the P-wave ( SAPW ) is an independent predictor of recurrence of atrial fibrillation ( AF ) post cardioversion ( CV ) , and to assess atrial remodeling using SAPW . BACKGROUND There are limited electrophysiologic data to predict the recurrence of AF post-CV . The electrical remodeling that occurs post-CV is poorly understood . METHODS Sixty-four patients with persistent AF undergoing CV were prospect ively enrolled . SAPW parameters were measured the day of CV and repeated at 1 month . These SAPW parameters were compared to other baseline indices for the recurrence of AF . RESULTS Sixty patients ( 94 % ) had successful CV . At 1 month , 22 ( 37 % ) maintained sinus rhythm ( SR ) . The SAPW total duration decreased significantly in those who remained in SR ( 159 ms + /- 19 to 146 ms + /- 17 ; P duration of AF ( 46 + /- 50 days vs 147 + /- 227 days , P = 0.03 ) and the presence of left ventricular hypertrophy ( LVH , 12 % vs 65 % , P = 0.0006 ) were significantly associated with recurrence of AF . Atrial size strongly correlated with the SAPW duration in patients who remained in SR ( R(2)= 0.67 , P = 0.003 ) but not in those who returned to AF ( R(2)= 0.11 , P = 0.65 ) . CONCLUSIONS Atrial electrical reverse remodeling occurs in patients with AF who maintain SR post-CV . This remodeling is likely inversely related to the duration of AF and LVH . SAPW duration does not predict recurrence of AF post-CV",
"UNLABELLED There are conflicting reports on the relationship between left atrial dimension ( LAD ) determined by echo-cardiography and the incidence of atrial fibrillation ( AF ) recurrence after electrical cardioversion ( EC ) . We hypothesized that left atrial volume ( LAV ) by echocardiography might better differentiate patients who will have recurrence of AF after EC . METHODS Forty-one patients having EC for AF were prospect ively studied by echocardiography . LAD was measured by American Society of Echocardiography guidelines as the anterior-posterior dimension in the parasternal view . LAV was measured by Simpson 's method using an off-line analysis system and reported as the average of values from the apical four-chamber and two-chamber views . RESULTS ( Data are mean + /- SEM ) : Patient follow-up was 15 + /- 10 months . No cutoff value of LAV predicted AF recurrence , but all three patients with LAD greater than 65 mm had AF recurrence . Compared with patients maintaining normal sinus rhythm ( NSR ) ( N = 18 ) , the AF group ( N = 23 ) had a lower percentage of antiarrhythmic drug use , especially type IA agents ( p Patients who stayed in NSR tended to have shorter AF duration before EC ( 16 + /- 15 v 63 + /- 122 weeks , p = .08 ) but did not differ in age ( 53 + /- 27 v 58 + /- 23 years ) , LAD ( 51.1 + /- 7.7 v 54.2 + /- 9.4 mm ) or LAV ( 85.1 + /- 24.3 v 95.1 + /- 33.3 mL ) . CONCLUSIONS ( 1 ) LAV by echocardiography does not improve identification of patients at risk for recurrence of AF after EC , ( 2 ) patients with LAD up to 65 mm may maintain NSR after EC , ( 3 ) LAD greater than 65 mm is associated with AF recurrence , and ( 4 ) use of antiarrhythmic drugs and the duration of AF before EC may be better predictors of maintenance of NSR than echocardiographic measures of left atrial parameters"
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BACKGROUND Ankylosing spondylitis ( AS ) is a chronic rheumatic disease . Due to the consequences of the disease , physiotherapy is regarded to be an important part of the treatment . OBJECTIVES The objective is to summarise the available scientific evidence on the effectiveness of physiotherapy interventions in the management of AS . SEARCH STRATEGY We search ed the Cochrane Musculoskeletal Group Trial register , Cochrane Controlled Trials Register , MEDLINE , EMBASE , CINAHL and Pedro up to February 2000 for all relevant publications , limited to English and Sc and inavian language s. The reference lists of relevant articles were checked and the authors of included articles were contacted . SELECTION CRITERIA We included r and omised and quasi r and omised studies where the participants were patients with AS , classified by the New York criteria , and where at least one of the comparison groups received some kind of physiotherapy . The main outcomes of interest were spinal mobility , pain , stiffness , physical function and global assessment of change . DATA COLLECTION AND ANALYSIS Both review ers independently selected trials for inclusion , extracted data and assessed trial quality . Investigators were contacted to obtain missing information . MAIN RESULTS Three trials were included with 241 participants , and all were assessed to have moderate to high risk of bias . Two trials compared the effect of supervised group physical therapy with an individualised home exercise program , and reported differences in favour of the supervised group . For pain and stiffness , the relative difference in change from baseline for the supervised group compared to the home exercise group was 50 % after treatment . One trial compared an individual program of exercises and disease education with no intervention , and found differences in favour of the exercise group . REVIEW ER 'S CONCLUSIONS The tendency toward positive effects of physiotherapy , in the management of AS , call for further research in this field in order to reach sufficient evidence on which physiotherapy modalities and applications are to be recommended . New trials should address other physiotherapy interventions commonly used in practice . There is not sufficient evidence yet available to base recommendations for or against the use of physiotherapy interventions for ankylosing spondylitis | [
"A study was performed to evaluate the extent to which the medical literature may be misleading as a result of selective publication of r and omized clinical trials ( RCTs ) with results showing a statistically significant treatment effect . Three hundred eighteen authors of published trials were asked whether they had participated in any unpublished RCTs . The 156 respondents reported 271 unpublished and 1041 published trials . Of the 178 completed unpublished RCTs with a trend specified , 26 ( 14 % ) favored the new therapy compared to 423 of 767 ( 55 % ) published reports ( p less than 0.001 ) . For trials that were completed but not published , the major reasons for nonpublication were \" negative \" results and lack of interest . From the data provided , it appears that nonpublication was primarily a result of failure to write up and su bmi t the trial results rather than rejection of su bmi tted manuscripts . The results of this study imply the existence of a publication bias of importance both to meta- analysis and the interpretation of statistically significant positive trials",
"Abstract . A cohort of 25 patients with spondylarthropathy ( SpA ) participated in a 3-year follow-up study of functional changes before and after an intensive 3-week inpatient course . They answered questions in the following functional status/disability indices : Bath ankylosing spondylitis functional index ( BASFI ) , Dougados functional index ( DFI ) , health assessment question naire for spondylarthropathy ( HAQ-S ) , Bath ankylosing spondylitis disease activity index ( BASDAI ) , Bath ankylosing spondylitis patient global assessment ( BAS-G ) , and horizontal visual analogue scale for stiffness ( stiffness VAS ) before and after the course and 3 years later by mail . A control group of 18 consecutive SpA patients from the waiting list for an inpatient course filled in the same question naires as study patients 3 months before entry and again 3 weeks later at home without rehabilitation . During the waiting time for the inpatient course , control group global assessment s ( BASDAI , BAS-G , and stiffness-VAS ) worsened slightly , and BASFI but not HAQ-S and DFI scores remained unchanged in the 3 weeks without treatment . The results of the 25 study patients showed small and not significant improvements in all functional index scores ( BASFI –0.5 points , DFI –1.1 , and HAQ-S –0.17 ) , whereas improvements were significant in BASDAI , BAS-G , and stiffness-VAS ( –13 mm , –13 mm , and –11 mm , respectively ) after the 3-week inpatient course . At 3-year follow-up , these small changes had disappeared and the changes were not significant . The global indices and BASFI worsened slightly ( 0.4 ) from baseline results , while DFI was slightly better ( –0.4 ) and HAQ-S remained at the post-treatment level after 3 years . Thus , BASFI was the most sensitive to changes , whereas DFI and HAQ-S were relatively insensitive . All six indices correlated highly significantly with each other ( ICC 0.53–0.94 ) . The natural course of spondylarthropathy leads to progression of functional impairments , which seems to be preventable with intensive rehabilitation , at least in the short term . Among the three functional indices , BASFI seems to be the most sensitive tool",
"BACKGROUND Although exercise is a commonly recommended treatment for ankylosing spondylitis ( AS ) , little is known about the effectiveness of unsupervised recreational and back exercises . We examined the effects of recreational exercise and back exercises on patient-reported pain severity , stiffness severity , and functional disability in a prospect i ve longitudinal study of 220 patients with AS . METHODS Participants provided information on exercise habits and health status every 6 months using mailed question naires ( median follow-up , 4.5 years ) . Pain severity and stiffness severity were measured using visual analog scales , and functional disability was measured using the Health Assessment Question naire ( HAQ ) Disability Index . RESULTS Among all patients , there were no associations between either the number of exercise minutes per week or the number of days of back exercise per week and short-term ( 6-month ) changes in pain , stiffness , or HAQ Disability Index . However , among those who had AS for 15 years or less , pain scores were 0.18 points lower ( on a scale of 0 - 3 ; P = .04 ) , and stiffness scores were 6.4 points lower ( on a scale of 0 - 100 ; P = .005 ) during periods with more than 200 minutes per week of exercise compared with periods with 0 to 30 minutes of exercise per week . Among those who had AS for more than 15 years , pain scores were 0.11 points lower ( on a scale of 0 - 3 ; P = . 03 ) , and HAQ Disability Indexes were 0.08 points lower ( on a scale of 0 - 3 ; P back exercise compared with periods when back exercises were not performed . Less intense levels of exercise were not associated with improvements in health status . CONCLUSIONS Unsupervised recreational exercise improves pain and stiffness , and back exercise improves pain and function in patients with AS , but these effects differ with the duration of AS . Health status is improved when patients perform recreational exercise at least 30 minutes per day and back exercises at least 5 days per week . Arch Intern Med . 2000;160:2969 -",
"Sixteen individuals with rheumatoid arthritis ( RA ) and 19 individuals with ankylosing spondylitis ( AS ) participated in this 3-year follow-up study . The individuals in each disease group were allocated to an experimental group ( E group ) and a comparison group ( C group ) . They were investigated by question naire , clinical examination of the stomatognathic system , and laboratory tests . The individuals of the two E groups had performed a physical training program of the stomatognathic system during 3 weeks . After 3 years most of the patients in the E groups reported an unaltered or decreased severity of symptoms and signs from the stomatognathic system compared with the initial status . The clinical dysfunction score according to Helkimo ( CDS ) was lower in the RA group , and the mouth opening capacity was larger than before training . In the AS group there was no long-term change in the CDS but an increase of mouth opening capacity . The general inflammatory disease process in the RA group showed an increased activity during this follow-up period as assessed by erythrocyte sedimentation rate . This study suggests that local physical training of the stomatognathic system has a positive effect in individuals with RA",
"Summary Long-term effects of three or four-week inpatient physiotherapy and exercise courses were studied in 141 adult patients with ankylosing spondylitis ( AS ) . Eight cervical and thoracolumbar range of motion ( ROM ) measurements and straight leg raise test , vital capacity ( VC ) and fitness index were measured at the beginning and end of an intensive course and 15 months later . All nine mobility measurements , vital capacity and fitness index were significantly improved after the course . Fifteen months later only chest expansion and vital capacity had significantly deteriorated from the baseline , while CR , FFD and fitness index were still significantly better . Disease duration did not influence treatment results .We conclude that it is possible by means of intensive rehabilitation courses to prevent for more than one year deterioration of spinal function and fitness in AS patients irrespective of disease duration",
" Fifty-three patients with ankylosing spondylitis ( AS ) were r and omly allocated ; 26 experimental patients received physiotherapy and disease education , 27 control patients received neither . The primary treatment outcome was change in spinal mobility measured at 4 months by fingertip-to-floor distance . Experimental patients had more improvement in fingertip-to-floor distance ( p2 less than 0.004 ) and in function ( p2 less than 0.001 ) than control patients . Physiotherapy with disease education is effective in the treatment of patients with AS",
"OBJECTIVE Cost effectiveness analysis is helpful in setting priorities for funding of health care programs . We studied the cost effectiveness of supervised group physical therapy compared to unsupervised exercises at home in patients with ankylosing spondylitis ( AS ) . METHODS A total of 144 patients with AS ( modified New York criteria ; mean age : 43 years ) were r and omized to unsupervised daily individualized exercises at home for 9 months or the same plus supervised group physical therapy ( 3 h weekly ) . At baseline and after 9 months we measured spinal mobility ( thoracolumbar flexion and extension ) , fitness ( maximum work capacity by ergometry ) , and patient 's global assessment of change as measured on a visual analog scale . We used a question naire at baseline and a diary during the trial to measure AS related direct medical costs , such as doctor visits , paramedical treatment , medication and hospitalization . RESULTS The mean effects of group therapy and home exercises were , respectively , + 0.9 cm ( 16 % ) and + 0.5 cm ( 9 % ) for mobility , + 7 watts ( 4 % ) and -2 watts ( -1 % ) for fitness , and + 1.7 ( 34 % ) and + 0.3 ( 6 % ) for global health . These 3 differences were significant ( p mobility , p = 0.05 for fitness and p global health ) . During the trial total medical costs decreased by an average of US $ 379 ( 44 % ) for group therapy , and by $ 257 (35%)/patient/year for the \" home \" group . Additional costs of group therapy were estimated at $ 531/patient/year ( $ 177 for accommodation , $ 256 for therapist and $ 98 for material s ) . After the study 75 % of the patients wanted to continue group physical therapy and were willing to pay for it . CONCLUSION Compared to therapy at home , additional benefits of group therapy cost $ 531/year , but reduced direct medical costs by $ 122/year . Hence , the beneficial effects of group therapy cost $ 409/patient with AS/year",
"Two sets of criteria have been proposed to discriminate spondylarthropathies ( SA ) from other rheumatic diseases . To evaluate their performance , we conducted a cross-sectional study in the patients observed during one week in 28 French Departments of Rheumatology by 91 staff-teaching physicians . The physicians had to apply these criteria to all their patients and had to classify them as definite SA , definite other rheumatic disease or possible SA . The analysis performed on the 2,088 patients with a definite diagnosis ( 124 SA and 1,964 controls ) showed the following results : ( table ; see text ) Of the 140 patients with possible SA , 37 fulfilled both sets of criteria , 22 the ESSG criteria alone and 12 the Amor criteria alone . These data suggest that a ) the overall performance of these two sets of criteria is similar ; b ) this performance is better in the group of patients with a definite diagnosis ; c ) the patients without a definite diagnosis require a longer follow-up to assess the clinical relevance of these two sets of criteria",
"PURPOSE Group physical therapy in patients with ankylosing spondylitis was studied to determine whether beneficial effects persisted after cessation of the intervention . METHODS After a 9-month period of supervised group physical therapy , 68 patients were r and omized for another 9 months to unsupervised daily exercises at home ( discontinuation group ) or continuation of weekly sessions of supervised group physical therapy ( continuation group ) . Endpoints were spinal mobility ( thoraco-lumbar flexion and extension , chest expansion , cervical rotation ) , fitness ( maximum work capacity ) , functioning ( Sickness Impact Profile ( SIP ) , Health Assessment Question naire for the Spondylarthropathies [ HAQ-S ] , Functional Index [ FI ] ) , and patient 's global health assessment on a visual analogue scale . RESULTS Time for exercises at home was significantly higher in the continuation than in the discontinuation group ( mean duration 1.9 versus 1.2 hr per week , P global health ( mean improvement 1.6 ; 32 % ) and in SIP score . Scores for thoraco-lumbar mobility and HAQ-S did not change very much , whereas chest expansion , cervical rotation , fitness , and FI deteriorated . The average attendance for group therapy sessions was 62 % . The discontinuation group improved only marginally ( 0.2 ; 4 % ) in global health , whereas all other endpoints decreased . Only for global health and HAQ-S were the differences statistically significant in favor of the continuation group . CONCLUSIONS Global health and functioning are sustained or even improved further if group physical therapy is continued . Spinal mobility decreased slightly in both groups",
"OBJECTIVE Our previous r and omized clinical trial showed a 4-month home physiotherapy program was effective for patients with ankylosing spondylitis . This followup study reports on 22 control patients who received the previously withheld treatment and 24 experimental patients who received followup treatment as needed . METHODS The primary outcome measure was spinal mobility measured by fingertip-to-floor distance using a portable measuring device specially design ed and vali date d for this study . RESULTS Following treatment , fingertip-to-floor distance did not change in control patients ( P2 = 0.145 ) . Between 4 and 8 months , fingertip-to-floor distance did not change in experimental patients ( P2 = 0.143 ) ; however , initial improvement achieved was maintained . The experimental group at 4 months was better than the control group at 8 months ( P2 = 0.038 ) . CONCLUSION The home physiotherapy treatment program must be delivered as rigorously as it was in the initial trial to be effective . The benefit from this treatment program can be maintained with very little intervention",
"Objective : The objective was to prospect ively evaluate the short as well as the long‐term effects of intensive physiotherapy in a stable , sunny and warm climate on physical function and health related quality of life in patients with rheumatoid arthritis ( RA ) and spondylarthropathies ( SpA ) . Methods : Ninety‐three Swedish patients with RA and SpA receiving physiotherapy for 4 weeks in Israel or Tenerife were followed for 6 months . Physical function was evaluated by the Swedish version of Stanford Health Assessment Question naire ( HAQ ) and quality of life by the Nottingham Health Profile ( NHP ) question naire . Results : There were significant improvements in HAQ‐scores and global NHP‐scores as well as all subcategories of NHP immediately after the treatment abroad , effects that were still measurable after six months . At that time point nearly half of the patients had clinical ly meaningful reduction of HAQ‐scores ( ≥0.25 ) . Conclusion : Physiotherapy in a warm and stable climate , with many hours of daily sunshine , is a valuable treatment complement for Swedish patients with RA and",
"OBJECTIVE Home based self-care is essential for successful management of ankylosing spondylitis ( AS ) . We design ed an intervention package aim ed at promoting self-care and regular longterm exercise and evaluated its effect on outcome . METHOD Members of our data base ( n = 4569 ) were r and omly selected and r and omized to an intervention group ( IG ) or a followup control group ( CG ) . The intervention consisted of an exercise/information video , exercise progress chart , patient education booklet , and AS exercise reminder stickers . The outcome measures were function ( BASFI ) , disease activity ( BASDAI ) , global well being ( BAS-G ) , exercise self-efficacy ( ESE ) , arthritis self-efficacy ( SES ) , and quantity of AS mobility/aerobic exercise assessed at baseline and 6 months . RESULTS Of the 200 subjects , 155 completed the study ( 75 IG and 80 CG ) . Baseline analysis showed no differences between the CG and the IG . At 6 months , analysis revealed no statistically significant between-group differences for the BASFI , BASDAI , and BAS-G. although the p value of 0.08 for function approached significance . Self-efficacy for exercise showed a significant improvement in the IG ( p = 0.045 ) . There were no between-group differences for the SES pain and other symptoms subscales . Finally , there was a significant increase in self-reported AS mobility ( p aerobic exercise ( p An exercise intervention package design ed to promote self-management in AS ( 1 ) significantly improves self-efficacy for exercise ; ( 2 ) significantly improves self-reported levels of exercise ; ( 3 ) reveals a trend for improvement in function ( BASFI )",
"PURPOSE To study the effects of adding supervised group physical therapy to unsupervised individualized therapy in ankylosing spondylitis . METHODS One hundred forty-four patients were r and omized to exercises at home , or the same plus weekly group physical therapy for 9 months . Endpoints were spinal mobility , fitness ( maximum work capacity by ergometry ) , functioning ( Sickness Impact Profile , Health Assessment Question naire for the Spondylarthropathies , and Functional Index ) , and patient 's global assessment of change on a 10-cm visual analogue scale . RESULTS Thoracolumbar flexion and extension increased by an average of 0.5 cm ( 9 % ) after home exercises , and by 0.9 cm ( 16 % ) after group therapy . Maximum load in ergometry decreased by 2 W ( 1 % ) after home exercises , but increased by 7 W ( 4 % ) after group therapy . Global assessment improved by 0.3 ( 6 % ) after home exercises , and by 1.7 ( 34 % ) after group therapy . These three differences were statistically significant . There were no significant differences in chest expansion , cervical rotation , or the self- assessment s of functioning . CONCLUSIONS Group physical therapy proved superior to individualized therapy in improving thoracolumbar mobility and fitness , and had an important effect on global health reported by the patients",
"OBJECTIVE To evaluate the cost effectiveness and cost utility of a 3-week course of combined spa therapy and exercise therapy in addition to st and ard treatment consisting of antiinflammatory drugs and weekly group physical therapy in ankylosing spondylitis ( AS ) patients . METHODS A total of 120 Dutch out patients with AS were r and omly allocated into 3 groups of 40 patients each . Group 1 was treated in a spa resort in Bad Hofgastein , Austria ; group 2 in a spa resort in Arcen , The Netherl and s. The control group stayed at home and continued their usual activities and st and ard treatment during the intervention weeks . After the intervention , all patients followed weekly group physical therapy . The total study period was 40 weeks . Effectiveness of the intervention was assessed by functional ability using the Bath Ankylosing Spondylitis Function Index ( BASFI ) . Utilities were measured with the EuroQoL ( EQ-5D(utility ) ) . A time-integrated summary score defined the clinical effects ( BASFI-area under the curve [ AUC ] ) and utilities ( EQ-5D(utility)-AUC ) over time . Both direct ( health care and non-health care ) and indirect costs were included . Re source utilization and absence from work were registered weekly by the patients in a diary . All costs were calculated from a societal perspective . RESULTS A total of 111 patients completed the diary . The between-group difference for the BASFI-AUC was 1.0 ( 95 % confidence interval [ 95 % CI ] 0.4 - 1.6 ; P = 0.001 ) for group 1 versus controls , and 0.6 ( 95 % CI 0.1 - 1.1 ; P = 0.020 ) for group 2 versus controls . The between-group difference for EQ-5D(utility)-AUC was 0.17 ( 95 % CI 0.09 - 0.25 ; P mean total costs per patient ( including costs for spa therapy ) in Euros ( euro ; ) during the study period were euro;3,023 for group 1 , euro;3,240 for group 2 , and euro;1,754 for the control group . The incremental cost-effectiveness ratio per unit effect gained in functional ability ( 0 - 10 scale ) was euro;1,269 ( 95 % CI 497 - 3,316 ) for group 1 , and euro;2,477 ( 95 % CI 601 - 12,098 ) for group 2 . The costs per quality -adjusted life year gained were euro;7,465 ( 95 % CI 3,294 - 14,686 ) for group 1 , and euro;18,575 ( 95 % CI 3,678 - 114,257 ) for group 2 . CONCLUSION Combined spa-exercise therapy besides st and ard treatment with drugs and weekly group physical therapy is more effective and shows favorable cost-effectiveness and cost-utility ratios compared with st and ard treatment alone in patients with AS",
"OBJECTIVE To survey and to compare the one year effects of dynamic muscle training and progressive muscle relaxation as home exercise for patients with inflammatory rheumatic diseases ; and to identify predictors for compliance with a longterm home exercise regimen . METHODS Fifty-four patients ( mean age 54 yrs , mean symptom duration 14 yrs ) were assessed for health related quality of life , exercise motivation , joint tenderness , and physical capacities . After r and omization into 2 groups , every patient was instructed on one occasion in a 30 min program of either dynamic training or muscle relaxation to carry out at home , 5 times a week during 3 months , and then 2 - 3 times a week for another 9 months . RESULTS Seventeen patients in each group completed the one year exercise protocol , while 10 from each group did not . Compliance with the one year exercise regimen seemed to be predicted by high self-efficacy for exercise , regular range-of-motion exercises before the intervention , and being unmarried . After one year , minor improvements in physical effect ( p work effect ( p pain effect ( p emotional reactions ( p arm endurance ( p health status , joint tenderness , or physical capacities during the intervention period were found . CONCLUSION These results may improve the selection of patients for home exercise , and form a basis for improved administration of home exercise programs",
"Objective : To compare , in patients with ankylosing spondylitis ( AS ) , the effectiveness on pain , functional and psychological status of an intensive group exercise programme under the supervision of a physiotherapist and a home physiotherapy programme . Design : Fifty-one patients with AS were r and omly allocated into study and control groups . The study was design ed as a prospect i ve , double-blind study . Setting : Outpatient department , Istanbul Medical Faculty . Subjects : Patients who consulted with complaints of pain , morning stiffness and restricted range of movement with a confirmed diagnosis of ankylosing spondylitis . Interventions : Before exercise , both groups were given an education programme about AS . For group I patients an intensive exercise programme was organized under the supervision of a physiotherapist for six weeks . Group II patients had to practise exercises individually at home . Main outcome measures : Both groups were evaluated and compared for pain , functional and psychological status before treatment , at the end of treatment and three months after treatment using a visual analogue scale ( VAS ) for pain , Beck Depression Scale and Bath Ankylosing Spondylitis Functional Index ( BASFI ) . Results : Six patients withdrew , four from group I. Results from the remaining 45 showed more positive changes in the patients undertaking group exercise at six weeks and three months after treatment . Values showed a statistical significant difference in favour of group I. Conclusion : Group exercise in hospital may be more effective than home-based exercises at reducing impairment associated with ankylosing spondylitis",
" Twenty-one patients with ankylosing spondylitis were admitted for two weeks bedrest , postural and mobilizing exercises . Eleven received low-dose corticotrophin and 10 received placebo injections during their admission and all were review ed after two months . In-patient therapy result ed in significant improvements in function , early morning stiffness , spinal pain , lumbar extension and lateral flexion , finger-floor distance and wall-tragus distance . These improvements were maintained at two months . Biplanar radiography confirmed significant improvements of lumbar spine mobility in 14 male subjects studied . Less improvement occurred in neck movements and these were not maintained . There were no differences between the two treatment groups"
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Menopause is associated with the onset of climacteric symptoms due to low estradiol levels , which may cause insufficient maturation of the vaginal mucosa . Vitamin D may regulate the growth and differentiation of cells that are adversely affected due to low estradiol levels , thereby restoring vaginal health . The objective of this systematic review , the first on this subject , was to investigate the effect of vitamin D on the vaginal health of menopausal women . PubMed , Embase , Scopus , Web of Science , and Google Scholar data bases and reference lists of h and - search ed articles were search ed for published studies from February 2000 to November 2018 . The selection criteria were as follows : r and omized or quasi-r and omized trials that compared the effects of vitamin D or related compounds , alone or with calcium , on vaginal health ( growth and differentiation of epithelial cells , dryness , acidity [ pH ] ) outcomes in menopausal women . The method ological quality of these studies was examined using the Cochrane tool checklist by two independent investigators , following which the data were extracted . Of six examined studies , two showed that vitamin D administration improved the growth and differentiation of vaginal epithelial cells , improved vaginal pH , and decreased vaginal dryness in menopausal women . Although the level of evidence for the effects of vitamin D on vaginal health is low in our study , we concluded that vitamin D may improve the vaginal health of women , especially during menopause | [
"Objective This study aims to determine whether vitamin D levels are associated with menopause-related symptoms in older women . Methods A r and omly selected subset of 1,407 women , among 26,104 potentially eligible participants of the Women ’s Health Initiative Calcium and Vitamin D trial of postmenopausal women aged 51 to 80 years , had 25-hydroxyvitamin D [ 25(OH)D ] levels measured at the Women ’s Health Initiative Calcium and Vitamin D trial baseline visit . Information about menopause-related symptoms at baseline was obtained by question naire and included overall number of symptoms and composite measures of sleep disturbance , emotional well-being , and energy/fatigue , as well as individual symptoms . After exclusions for missing data , 530 women ( mean [ SD ] age , 66.2 [ 6.8 ] y ) were included in these analyses . Results Borderline significant associations between 25(OH)D levels and total number of menopausal symptoms were observed ( with P values ranging from 0.05 to 0.06 for fully adjusted models ) ; however , the effect was clinical ly insignificant and disappeared with correction for multiple testing . No associations between 25(OH)D levels and composite measures of sleep disturbance , emotional well-being , or energy/fatigue were observed ( P ’s > 0.10 for fully adjusted models ) . Conclusions There is no evidence for a clinical ly important association between serum 25(OH)D levels and menopause-related symptoms in postmenopausal women",
"BACKGROUND It is unknown whether supplementation with calcium and vitamin D has an impact on menopause-related symptoms . METHODS As part of the Women 's Health Initiative Calcium/Vitamin D Supplementation Trial ( CaD ) , women were r and omized at 40 clinical sites to elemental calcium carbonate 1000 mg with vitamin D 400 IU daily or placebo . At the CaD baseline visit ( year 1 or year 2 ) and during a mean follow-up of 5.7 years , participants provided data on menopause-related symptoms via question naires . Generalized linear mixed effects techniques were used to address research questions . RESULTS After excluding participants with missing data ( N=2125 ) , we compared menopause-related symptoms at follow-up visits of 17,101 women r and omized to CaD with those of 17,056 women given the placebo . Women in the CaD arm did not have a different number of symptoms at follow-up compared to women taking the placebo ( p=0.702 ) . Similarly , there was no difference between sleep disturbance , emotional well-being , or energy/fatigue at follow-up in those who were r and omized to CaD supplementation compared to those taking the placebo . CONCLUSIONS Our data suggest that supplementation with 1000 mg of calcium plus 400 IU of vitamin D does not influence menopause-related symptoms over an average of 5.7 years of follow-up among postmenopausal women with an average age of 64 at the WHI baseline visit ",
"Background : Most of the women suffer from vaginal atrophy and dryness , and therefore , efficient and safe treatment is needed to improve vaginal lubrication . Vitamin D has several important functions which may be effective in proliferation and repair of the epithelial tissue . This study aim ed to evaluate the effect of vitamin D vaginal suppositories on maturation index , pH , and dryness in postmenopausal women . Material s and Methods : Women were enrolled in this double-blind clinical trial , in whom menopause occurred at least one year ago . Those women who had an abnormal Papanicolaou smear , had undergone hormonal treatment , or have had vaginal infection in the previous year were excluded . Forty-four women who found eligible were r and omized into two equal groups , the treatment and control groups , which received vitamin D and placebo vaginal suppository daily for 8 weeks , respectively . Vaginal pH and maturation value were measured at the beginning and end of the study . Pain , dryness , and paleness were assessed before treatment and at the end of the 2 , 4 , and 8 weeks of treatment . Results : In the treatment group , the number ( Mean ± SD ) of superficial cells increased ( 69.76 ± 12.4 ) and vaginal pH decreased ( 1.42 ± 0.67 ) significantly compared to the control group after 56 days . The mean pain significantly reduced after 8 weeks in the treatment group ( 1.23 ± 0.53 ) compared to the control group 1.95 ± 0.74 ( P 0.001 ) . The mean of dryness and paleness reduced significantly in the treatment group versus control at 56 days . Conclusions : Vitamin D is effective in improving the maturation index and decreased the pH and dryness of the vaginal atrophy due to menopause",
"Fracture prevention is one of the public health priorities worldwide . Estrogen deficiency is the major factor in the pathogenesis of postmenopausal osteoporosis , the most common metabolic bone disease . Different effective treatments for osteoporosis are available . Hormone replacement therapy ( HRT ) at different doses rapidly normalizes turnover , preserves bone mineral density ( BMD ) at all skeletal sites , leading to a significant , reduction in vertebral and non-vertebral fractures . Tibolone , a selective tissue estrogenic activity regulator ( STEAR ) , is effective in the treatment of vasomotor symptoms , vaginal atrophy and prevention/treatment of osteoporosis with a clinical efficacy similar to that of conventional HRT . Selective estrogen receptor modulators ( SERMs ) such as raloxifene and bazedoxifene reduce turnover and maintain or increase vertebral and femoral BMD and reduce the risk of osteoporotic fractures . The combination of bazedoxifene and conjugated estrogens , defined as tissue selective estrogen complex ( TSEC ) , is able to reduce climacteric symptoms , reduce bone turnover and preserve BMD . In conclusion , osteoporosis prevention can actually be considered as a major additional benefit in climacteric women who use HRT for treatment of climacteric symptoms . The use of a st and ard dose of HRT for osteoporosis prevention is based on biology , epidemiology , animal and pre clinical data , observational studies and r and omized , clinical trials . The antifracture effect of a lower dose HRT or TSEC is supported by the data on BMD and turnover , with compelling scientific evidence",
"Introduction : Role of Vitamin D is very well known for the functioning of many body organs . However , its role in the postmenopausal women in relation to various genitourinary disorders has been recognized recently . The main objective of this study was to evaluate role of Vitamin D in vaginal health , prolapse , bladder and bowel function , and bacterial vaginosis ( BV ) . Material s and Methods : This was a r and omized controlled study in which 200 geriatric female patients of 65–78 years of age divided into two groups comprising study and control group with 100 participants in each . Detailed obstetrical , gynecological , and clinical history was elicited . Detailed examination regarding the prolapse , urinary and bowel functions , and bacterial infections was done followed by follow-up of 3 and 6 months each . Chi-square and independent t-test used for data analysis . Results : Mean modified vaginal health index ( MVHI ) among patients with pelvic floor diseases was statistically significant with P = 0.0472 . There was a visible increasing trend in Vitamin D deficiency with increase in time since menopause ( P = 0.1193 ) . Patients with pelvic floor disease had mean Vitamin D statistically significant with P = 0.0462 . With increase in Vitamin D levels , MVHI was found to be better . The association of mean Vitamin D levels among patients with urinary incontinence as compared to controls was significant with P = 0.0460 . Association of mean Vitamin D levels in patients with fecal incontinence and BV as compared to controls was not statistically significant with P = 0.6304 and 0.79 , respectively . Low Vitamin D levels were associated with high mean parathyroid hormone ( PTH ) levels statistically significant with P = 0.034 . MVHI was found to increase significantly with Vitamin D supplementation at 3 and 6 months ' follow-up . There was increase in Vitamin D and calcium levels and fall in serum PTH levels at 3 and 6 months . Conclusions : Vitamin D levels were associated with a decreased risk of pelvic floor disorders , improved MVHI in women in geriatric age group",
"BACKGROUND it is known that vitamin D increases the population of superficial cells , so the objective of the present work was to evaluate the effect in Mexican postmenopausal women who were using or not oral calcitriol . METHODS postmenopausal women with vaginal dryness that received at r and om : calcium 500 mg orally every 24 h or calcitriol 0.25 μg every 24 h during two months . At the beginning of treatment and at two months a vaginal Pap smear was performed . The maturation index was determined and the estrogenic value was calculated . Vaginal dryness was evaluated using an analog visual scales and vaginal by the moistening of a pH test strip . Student 's t test was used for statistical analysis . RESULTS 23 postmenopausal women were studied and divided as follows : group I ( calcium ) = 11 women and group II ( calcitriol ) = 12 women . In the analyzed parameters only the average of superficial cells was significantly greater at the end of treatment in the calcitriol group . CONCLUSION calcitriol use increased the average of superficial cells in vaginal cytology , but did n't modify vaginal dryness",
"OBJECTIVES We assessed the effects of the discontinuation of long-st and ing transdermal estrogen replacement therapy ( > 4 years ) and substitution of this treatment by calcium or raloxifene on the vaginal epithelium and climateric symptoms in a study population of osteoporotic women . METHODS A total of 136 women ( mean age 55.5 years ) were r and omized to calcium ( 500 mg elemental calcium , 400 IU Vitamin D3 ) ( n=40 ) , raloxifene ( 60 mg/day ) ( n=48 ) , or estrogen patches ( 3.9 mg estradiol ) and progesterone ( 100 mg/day ) ( n=48 ) . Treatment was given for 1 year . The vaginal maturation value ( VMV ) , serum estradiol levels , and climateric symptoms using a 12-item modification of the SF-36 quality of life question naire were evaluated at baseline and at 6 and 12 months . RESULTS At 6 months , mean VMV decreased significantly ( P mean VMV in the calcium ( -38.7 % ) and raloxifene groups ( -32 % ) ( P Serum estradiol levels and changes of VMV correlated significantly at 6 months ( rho=0.361 , P hot flushes and palpitations in the calcium and raloxifene groups than in the estrogen/progesterone group . Raloxifene-treated women reported a significantly higher number of adverse events at 6 months compared to the other treatment groups . CONCLUSIONS Withdrawal and change of long-st and ing transdermal hormone replacement therapy by treatment with calcium or raloxifene result ed in worsening of vaginal atrophy assessed by the VMV , although it was not clinical ly perceived by the patients . However , increases in dyspareunia and urinary leaks were reported . Menopausal complaints related to vasomotor symptoms worsened in the calcium- and raloxifene-treated groups and persisted throughout the study period",
"AIM Affective and behavioural disorders possibly concomitant to the vasomotor menopausal symptoms worsen quality of life . A rational formulation containing soy isoflavones ( 60 mg ) , lactobacilli ( 500 millions spores ) , calcium ( 141 mg ) and vitamin D3 ( 5 microg ) was added of Magnolia bark extract ( 60 mg ) and magnesium ( 50 mg ) ( Estromineral serena , ES ) . The Magnolia extract active principles interact with GABA system and exhibit a sedative central action . Magnesium intervenes in enzymatic reactions of the energetic metabolism and protects the bone integrity . Aim of this controlled study was to compare the clinical activity and safety of ES versus calcium+vitamin D3 ( Ca+D ) in menopause . METHODS A controlled , r and omised , multicentre study was carried out in symptomatic menopausal women with sleep or mood alterations . Women received 1 tablet/day of ES or Ca+D for 24 weeks . Symptoms during the treatment and final judgements on efficacy and acceptability were evaluated . RESULTS Eighty-nine women ( 44 ES and 45 Ca+D , mean age 53.8 years , in menopause since 56.6 months ) participated to the study . Flushing , nocturnal sweating , palpitations , insomnia , asthenia , anxiety , mood depression , irritability , vaginal dryness , dyspareunia , and libido loss , significantly decreased in severity and frequency during ES versus Ca+D treatment even since the fourth week . Woman wellbeing ( good/very good 66.7 % vs 20 % ) judgement on efficacy ( 72.7 % vs 17.1 % ) and acceptability ( 93.9 % vs 31.4 % ) were significantly better for ES . CONCLUSIONS The controlled study showed the efficacy of Magnolia extract and magnesium on psycho-affective and sleep disturbances in menopause , in addition to the effects of isoflavones on vasomotor symptoms . A global natural approach to menopause with ES evidence d its therapeutic usefulness and safety",
"Background : Early menopause , defined as the cessation of ovarian function before the age of 45 y , affects ∼10 % of women and is associated with higher risk of cardiovascular disease , osteoporosis , and other conditions . Few modifiable risk factors for early menopause have been identified , but emerging data suggest that high vitamin D intake may reduce risk . Objective : We evaluated how intakes of vitamin D and calcium are associated with the incidence of early menopause in the prospect i ve Nurses ' Health Study II ( NHS2 ) . Design : Intakes of vitamin D and calcium from foods and supplements were measured every 4 y with the use of a food-frequency question naire . Cases of incident early menopause were identified from all participants who were premenopausal at baseline in 1991 ; over 1.13 million person-years , 2041 women reported having natural menopause before the age of 45 y. We used Cox proportional hazards regression to evaluate relations between intakes of vitamin D and calcium and incident early menopause while accounting for potential confounding factors . Results : After adjustment for age , smoking , and other factors , women with the highest intake of dietary vitamin D ( quintile median : 528 IU/d ) had a significant 17 % lower risk of early menopause than women with the lowest intake [ quintile median : 148 IU/d ; HR : 0.83 ( 95 % CI : 0.72 , 0.95 ) ; P-trend = 0.03 ] . Dietary calcium intake in the highest quintile ( median : 1246 mg/d ) compared with the lowest ( median : 556 mg/d ) was associated with a borderline significantly lower risk of early menopause ( HR : 0.87 ; 95 % CI : 0.76 , 1.00 ; P-trend = 0.03 ) . Associations were stronger for vitamin D and calcium from dairy sources than from nondairy dietary sources , whereas high supplement use was not associated with lower risk . Conclusions : Findings suggest that high intakes of dietary vitamin D and calcium may be modestly associated with a lower risk of early menopause . Further studies evaluating 25-hydroxyvitamin D concentrations , other dairy constituents , and early menopause are warranted",
"BACKGROUND Frequent use of personal , non protocol calcium supplements obscured an adverse effect of coadministered calcium and vitamin D ( CaD ) on cardiovascular risk in the Women 's Health Initiative ( WHI ) . OBJECTIVE We investigated the effects of the use of personal calcium or vitamin D supplements on other outcomes in the WHI CaD Study ( WHI CaD ) by using the WHI limited-access clinical trials data set . DESIGN The WHI CaD was a 7-y , r and omized , placebo-controlled trial of CaD ( 1 g Ca/400 IU vitamin D daily ) in 36,282 community-dwelling , postmenopausal women . The incidence of total cancer ( excluding nonmelanoma skin cancers ) , breast and colorectal cancers , hip and total fracture , and mortality was assessed by using Cox proportional hazards models . RESULTS In the WHI CaD , interactions between the use of either personal calcium or vitamin D supplements and CaD were found for total , breast , and colorectal cancers but not for fracture or mortality . In 15,646 women ( 43 % ) who were not taking personal calcium or vitamin D supplements at r and omization , CaD significantly decreased the risk of total , breast , and invasive breast cancers by 14 - 20 % and nonsignificantly reduced the risk of colorectal cancer by 17 % . In women taking personal calcium or vitamin D supplements , CaD did not alter cancer risk ( HR : 1.06 - 1.26 ) . CONCLUSIONS For women in the WHI CaD who were not taking personal calcium or vitamin D supplements at r and omization , CaD decreased the risk of total , breast , and colorectal cancers and did not change the risk of fractures or total mortality . The nonskeletal effects of CaD may be more important than the skeletal effects and should be considered when evaluating these supplements . The WHI CaD trial is registered at clinical trials.gov as NCT00000611",
"In post-menopausal period vulvo-vaginal atrophy (VVA)-related symptoms may seriously affect women 's quality of life . Hormonal replacement therapy effectively relieves these symptoms but it is not always safe or accepted , and a non-hormonal treatment is often needed instead . Over a period of 12 weeks , we tested the effect of a twice-a-week vulvo-vaginal application of a hyaluronic acid , AC collagen , isoflavones and vitamins-based cream ( Perilei Pausa ® ) on 35 women in post-menopausal period , reporting VVA-related symptoms . After 12 weeks of treatment with Perilei Pausa ® a significant improvement in vaginal dryness , vulvo-vaginal itching , dyspareunia ( P , dysuria ( P = 0.02 ) , nocturia ( P = 0.009 ) and pollakiuria ( P = 0.005 ) was reported by the women . Colposcopical score assessing the intensity of atrophic colpitis , cervico-vaginal paleness and petechiae was also reduced ( P = 0.037 , P = 0.016 and P = 0.032 , respectively ) . No significant difference in terms of maturation value of cervico-vaginal epithelium was observed . In conclusion , Perilei Pausa ® may represent an effective and safe alternative treatment of symptomatic VVA in post-menopausal women",
"INTRODUCTION Many postmenopausal women who are on hormone replacement therapy discontinue medications due to vaginal bleeding . Tibolone , a synthetic steroid , has minimal stimulatory effect on the endometrium . The aim of this study was to assess the effects of continuous HRT regimen and tibolone on the onset of vaginal bleeding and vaginal maturation value . MATERIAL S AND METHODS A total of 150 healthy women in postmenopausal period were r and omly enrolled in this controlled clinical trial . Patients were r and omly allocated into three groups , and were followed for six months . The first 50 women received 2.5 mg tibolone plus a Cal+D tablet ( 500 mg Calcium and 200 IU vitamin D ) daily , the second 50 women received 0.625 mg conjugated equine estrogen and 2.5 mg medroxyprogesterone acetate ( CEE/MPA ) plus one Cal+D tablet daily , and the remaining 50 received only one Cal+D tablet per day and served as the control group . Symptoms were recorded using a question naire that assessed vaginal bleeding or spotting , vaginal dryness and intention to continue the medications . Vaginal maturation value was assessed by examining vaginal smears before and after the treatment . The results for the three groups were analyzed using statistical methods . RESULTS In comparison with the control group , CEE/MPA and tibolone increased vaginal maturation value and decreased the frequency of vaginal dryness ( p continue the treatment regimen than those in the CEE/MPA or the control groups ( p Tibolone can serve as an appropriate choice for HRT as it has low rates of vaginal bleeding/ spotting episodes and high acceptance rate in postmenopausal women"
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Alternatives to the classical medial parapatellar ( MPP ) approach for total knee arthroplasty ( TKA ) include the mini-medial parapatellar ( MMPP ) , mini-subvastus ( MSV ) , mini-midvastus ( MMV ) and quadriceps-sparing ( QS ) approaches . The best approach has been not fully clarified . The purpose of the present study was to conduct a Bayesian network meta- analysis comparing these approaches . The present analysis was carried out according to the PRISMA extension statement for reporting systematic review s incorporating network meta-analyses of healthcare interventions . The data bases search was performed in October 2019 . All clinical trials comparing two or more approaches for primary TKA were considered for inclusion . The baseline comparability was evaluated through the analysis of variance ( ANOVA ) test . The statistical analysis was performed through the STATA software/MP . A Bayesian hierarchical r and om-effects model analysis was adopted in all the comparisons . Data from 52 articles ( 4533 patients ) were collected . The mean follow-up was 20.38 months . With regard to diagnosis , gender , age and BMI , adequate baseline comparability was detected . The MSV approach ranked better concerning clinical scores ( the lowest visual analogic scale , the higher KSS and KSFS ) and functional outcomes ( the shortest straight leg raise , the greatest degree of flexion and range of motion ) . Concerning perioperative data , the MSV evidence d the shortest hospital stay , while the MPP the shortest surgical duration and lowest estimated blood loss . According to the main findings of the present study , the mini-subvastus approach for total knee arthroplasty demonstrated superior overall compared to the other approaches . Orthopaedic surgeons should consider this approach in the light of the evidence and limitations of this Bayesian network meta- analysis | [
"This pilot double blind r and omised controlled study aim ed to investigate whether the midvastus ( MV ) approach without patellar eversion in total knee arthroplasty ( TKA ) result ed in improved recovery of function compared to the medial parapatellar ( MP ) approach . Patients were r and omly allocated to either the MV approach or the MP approach . Achievements of inpatient mobility milestones were recorded . Knee kinematics , muscle strength , Timed Up and Go , WOMAC , and daily step count were assessed before and up to six months after surgery . Cohen 's effect size d was calculated to inform the sample size in future trials . Twenty-eight participants ( 16 males , 12 females ) participated . Patient mobility milestones such as straight leg raise were achieved on average 1.3 days ( 95 % CI −3.4 to 0.7 , d = 0.63 ) earlier in the MV group . Knee extensor strength at 6 weeks after surgery was higher ( 95 % CI −0.38 to 0.61 , d = 0.73 ) in the MV group . No trends for differences between the groups were observed in knee kinematics , TUG , WOMAC , or step count . Our results suggest a short term advantage in the first 6 weeks after surgery of the MV approach over the MP approach , but a larger study is required to confirm these findings . This trial is registered with NCT056445",
"BACKGROUND It has been shown before that when compared with the medial para-patellar approach , the mid-vastus approach for TKR results in less post-operative pain for patients and more rapid recovery of straight leg raise . As far as we are aware the post-operative length of stay of the two groups of patients has not been compared . We postulated that the reduced pain and more rapid recovery of straight leg raise would translate into an earlier , safe , discharge home for the mid-vastus patients compared with those who underwent a traditional medial para-patellar approach . METHODS Twenty patients operated on by each of five established knee arthroplasty surgeons were evaluated prospect ively with regard to their pre and post-operative range of movement , time to achieve straight leg raise post-operatively and length of post-operative hospital stay . Only one of the surgeons performed the mid-vastus approach , and the measurements were recorded by physiotherapists who were blinded as to the approach used on each patient . RESULTS The results were analysed using a st and ard statistical software package , and although the mean length of stay was lower for the mid-vastus patients , the difference did not reach a level of significance ( p = 0.13 ) . The time taken to achieve straight leg raise post-operatively was significantly less in the mid-vastus group ( p mid-vastus approach reduces the time taken for patients to achieve straight leg raise , when compared with the medial para-patellar approach , on its own it does not translate into a significantly shorter length of hospital stay . In order to reduce the length of post-operative hospital stay with an accelerated rehabilitation program for TKR , a multi-disciplinary approach is required . Patient expectations , GP support , physiotherapists and nursing staff all have a role to play and the mid-vastus approach , in permitting earlier straight leg raising , significantly contributes to this",
"BACKGROUND During total knee arthroplasty ( TKA ) , surgical exposure requires mobilization technique of the patella . With this trial , we intended to investigate the effect of patella eversion on clinical outcome measures in simultaneous bilateral TKA . METHODS We prospect ively enrolled 44 patients ( 88 knees ) from April 2008 to June 20l4.One knee was operated with patella eversion ( group A ) and the other with patella lateral retraction ( group B ) r and omly . Follow-up results , including the operation time , complications , and the time of achieving straight leg raise ( SLR ) and 90 ° knee flexion , were recorded . The data of range of motion ( ROM ) and Visual Analogue Scale score were collected separately at 7 days , 3 months , 6 months , and 1 year postoperatively . RESULTS The time of achieving SLR was 2.7 ± 0.8 days in group A and 2.1 ± 0.7 DAYS in group B , which were significantly different ( P = .032 ) . Significant difference was found on active and passive ROM during the follow-up times between groups A and B , except the passive ROM at 6 months postoperatively . No significant difference was found on operation time , complications , patella baja or tilt , time of achieving 90 ° knee flexion , and Visual Analogue Scale score during the follow-up times . CONCLUSIONS Patellar eversion was adverse to the early knee function recovery after TKA ; it would delay the time of achieving SLR and decrease the passive and active ROM . In addition , more carefully and scientifically design ed r and omized controlled trials are still required to further prove the cl aim",
"Background Minimally invasive knee arthroplasty seeks to diminish the problems of traditional extensile exposures aim ing for more rapid rehabilitation of patients after surgery . Questions / purpose s To determine if the subvastus approach results in less perioperative pain and blood loss , shorter hospital stay , and improved function at both early and long-term followup . Methods One hundred patients were enrolled in a prospect i ve , r and omized trial . Fifty were operated on using a minimally invasive subvastus approach and the other 50 by a conventional , peripatellar approach . Minimum followup was 3 years . A repeated- measures analysis of variance was used to compare the Knee Society score and range of motion during followup . Results The minimally invasive approach result ed in greater perioperative bleeding but no increase in transfusions . No differences were found in postoperative pain between groups nor did hospital stay show any differences . The range of motion on the third day after surgery was greater in the minimally invasive group . No differences were found in surgical time , femoral or tibial component orientation or outliers , or complication rates . Both Knee Society score and range of motion were superior using the minimally invasive subvastus approach during followup out to 36 months . Conclusions The minimally invasive subvastus approach can result in improved long-term Knee Society scores and range of motion of total knee arthroplasty without increased risk of component malalignment , surgical time , or complication rate . Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"The purpose of this prospect i ve study was to analyze the biochemical markers of muscle damage and inflammation in patients treated with the mini-midvastus approach or the medial parapatellar approach for total knee arthroplasty . Of 60 patients who underwent unilateral total knee arthroplasty , 30 were treated with the mini-midvastus approach ( MMV group ) and 30 were treated with the medial parapatellar approach ( MPP group ) . Serum creatine kinase , myoglobin , lactate dehydrogenase , glutamic oxaloacetic transaminase , C-reactive protein , interleukin-6 , and interleukin-1β levels were measured preoperatively , immediately postoperatively ( except for C-reactive protein level ) , and on postoperative days 1 , 2 , and 3 . Student 's t test , Pearson 's chi-square test , and Fisher 's exact test were used to compare the outcomes between the 2 groups . Compared with the MPP group , a significant increase in serum creatine kinase level existed in the MMV group on postoperative days 2 ( P=.08 ) and 3 ( P=.09 ) and cumulatively ( P=.02 ) . However , significantly elevated C-reactive protein and interleukin-6 levels existed in the MPP group . According to the serum creatine kinase levels , the mini-midvastus approach has no superiority over the medial parapatellar approach in terms of sparing muscle and may cause more muscle damage . Further study is warranted to determine the correlation between biochemical markers and functional deficits",
"A prospect i ve r and omized study was performed on 20 patients undergoing one-stage bilateral knee arthroplasty . One knee was exposed using a st and ard median parapatellar arthrotomy and the other knee with a subvastus arthrotomy . All patients underwent quantitative strength testing before surgery and at 1 week , 1 month , and 3 months after surgery . The knees were also evaluated for range of motion , and patients , who were blinded as to the approach used , completed question naires at each evaluation period as to their preference , if any , regarding knee pain and level of function . There was no difference in the range of motion between knees exposed with the paramedian or subvastus arthrotomy at any time period . The subvastus knees demonstrated significantly greater strength at the 1-week and 1-month intervals , but there was no strength difference at the 3-month interval . There were more lateral releases performed in the paramedium knees , and three minor complications were related to the subvastus approach . Patients who expressed a preference chose the subvastus knee 4:1 over the paramedian knee . The subvastus approach offers a reasonable alternative to the paramedian arthrotomy and preserves greater quadriceps strength in the early postoperative period",
"Purpose Whether minimally invasive total knee arthroplasty ( MIS-TKA ) could offer better and faster recovery without the deviation of post-operative prosthesis position and limb alignment is still controversial . This prospect i ve and r and omized study was conducted to compare the clinical and radiological outcomes between patients who underwent the mini-subvastus approach of MIS-TKA and those who underwent the medial parapatellar approach of traditional TKA . Methods Fifty patients , including 50 knees , who required TKA due to osteoarthritis were r and omized to the mini-subvastus group ( group I ) or the medial parapatellar group ( group II ) . All patients accepted the same method of anaesthesia , equal support therapy and identical rehabilitation exercise after surgery . The evaluation system included operation time , tourniquet time , blood loss , skin incision length in flexion , straight leg raising time , the time of lower limb muscle strength up to grade 4 , the time of walking with aid or without aid , the time of walking up and down the stairs , the active flexion angle , range of movement ( ROM ) , the Knee Society Scores ( KSS ) , visual analogue score for pain ( VAS ) , hospital stays and radiographic outcomes . Results The mini-subvastus approach offered smaller skin incision length in flexion , but at the cost of operation time ( P tourniquet time and blood loss . The patients in group I could achieve straight leg raising , the lower limb muscle strength up to grade 4 , walking with or without aid , and walking up and down the stairs earlier ( P The active flexion angle , ROM , VAS and KSS in group I were superior to those in group II until six months post-operatively ( P radiological outcomes ( P > 0.05 ) . Conclusions The mini-subvastus approach could offer faster recovery , less pain and shorter hospital stays without compromising the principles of proper prosthesis position and limb alignment compared with the medial parapatellar approach",
"& NA ; The purpose of this r and omized study was to compare clinical and surgical outcomes of total knee replacements ( TKRs ) in the early postoperative period using midvastus approach versus medial parapatellar approach in Asian population in a double blind manner . Forty‐two knees each were operated using midvastus approach and the medial parapatellar approach . Clinical parameters that were evaluated included Knee Society score ( KSS ) ; knee pain using visual analogue scale ( VAS ) on day 1 , 1 week , and 1 month ; time required to straight leg raise ( SLR ) ; patellar tracking ; mean extensor lag at 1 week and 1 month ; and time of discharge from the hospital . Surgical parameters that were evaluated included tourniquet time , incidence of lateral retinacular release , estimated blood loss , and any complications during the surgery . KSS at 1 week and 1 month postoperatively were significantly higher in the midvastus group as compared with medial parapatellar group ; though similar at 3 months , 6 months , and 1 year . The patients in midvastus group required fewer number of lateral retinacular releases ; achieved SLR earlier ; had less mean extensor lag at 1 week ; had less mean VAS score at day 1 , 1 week , and 1 month ; and had shorter hospital stay . There was no significant difference in the mean tourniquet time and estimated blood loss . One patient had patellar maltracking in the medial parapatellar group as compared with none in midvastus group . Midvastus approach to TKR results in quicker functional recovery with early discharge and rehabilitation in the Asian population as compared with medial parapatellar approach",
"Abstract Simultaneous bilateral TKAs subject patients to more arduous and painful functional recovery and increased risk of hemodynamic complications than staged bilateral TKAs . Minimally invasive TKA ( MIS-TKA ) reportedly results in more rapid return of function by limiting the amount of soft tissue disruption . We asked whether bilateral MIS-TKA had advantages over conventional TKA with respect to faster functional recovery . We prospect ively r and omized 30 patients into an MIS group ( mini-medial parapatellar approach , 15 patients ) and a conventional group ( conventional medial parapatellar approach , 15 patients ) . We recorded range of motion and the time required to regain the ability to walk without assistance . Functional recovery in the MIS group was faster in rehabilitation milestones of walking without assistance and gain in range of motion . Minimally invasive TKA may benefit patients undergoing simultaneous bilateral procedures with faster functional recovery . Level of Evidence : Level II , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence",
"Purpose The proponents of minimally invasive total knee arthroplasty ( TKA ) have reported better functional recovery than conventional TKA . In most of the previous studies , the results were shown with the relatively subjective methods . We investigated the objective results with a dynamometry in this prospect i ve r and omized study . It was hypothesized that minimally invasive TKA would have a better and earlier recovery of quadriceps force in terms of the objective numeric data . Methods Sixty-six TKAs were prospect ively r and omized into two groups . Thirty-three knees underwent minimally invasive TKA using mini-midvastus approach and 33 knees underwent conventional TKA using medial parapatellar approach . The quadriceps force was assessed using a dynamometer . The data were collected preoperatively and at postoperative 6 weeks , 3 months , 6 months and 1 year consecutively . Results The mean of quadriceps force in minimally invasive TKA group at postoperative 6 weeks was greater than conventional TKA after removing the covariate ( preoperative quadriceps force ) with analysis of covariance ( P = 0.002 ) , but thereafter , the difference was not significant till 1 year . Meanwhile , with repeated measures analysis of variance , conventional TKA group had greater quadriceps recovery than minimally invasive TKA group during postoperative 6 weeks to 3 months ( P = 0.035 ) . The proportion of patients unable to recover the quadriceps force to their preoperative levels by 1 year postoperatively was similar in two groups . Conclusion Minimally invasive TKA has benefit in quadriceps recovery at earlier rehabilitation period although catch-up recovery in conventional TKA was accelerated from the postoperative 6 weeks to 3 months . It may support the concept of early return to full activity after minimally invasive TKA , and patients might get back early to normal life . Level of evidence Therapeutic study , Level",
"The results of minimally invasive techniques used for total knee replacement are controversial . Despite reported advantages such as faster recovery , there are some concerns regarding component positioning . We compared mini-midvastus versus medial parapatellar arthrotomy with respect to component position and functional results . We included 70 osteoarthritis total knee replacement patients in our study . Patients were r and omised for the approach . We recorded Knee Society scores before and after the surgery and radiological component position . Patients were followed up to 12 weeks after the surgery . We found that the mini-midvastus approach was associated with better Knee Society scores six weeks after surgery ; after 12 weeks the difference was not statistically significant . We found no difference related to the approach in radiological component position . The mini-midvastus approach is associated with faster recovery and reproduces the same accuracy in component positioning as the medial parapatellar approach . RésuméLes techniques de chirurgie mini-invasives sont controversées dans les prothèses totales du genou . En dépit d’une récupération plus rapide , il est nécessaire de bien observer la position des implants . Nous avons comparé un abord mini-midvastus versus à un abord parapatellaire médian sur les critères position des implants et sur les résultats fonctionnels . Matériel et méthode : 70 approches du genou avec remplacement total ont été étudiés . Les patients ont été r and omisés selon la voie d’abord . Le score de la Knee Society et l’étude radiologique ont permis l’évaluation de ces prothèses . Les patients ont été suivis 12 semaines après l’intervention chirurgicale . Résultats : nous avons trouvé que l’abord mini-midvastus était associé à un meilleur score fonctionnel 6 semaines après l’intervention . Après 12 semaines , la différence n’est pas statistiquement significative . Nous n’avons pas trouvé de différence en ce qui concerne la position des implants . En conclusion : l’abord mini-midvastus est associé à une récupération plus rapide et , permet de positionner les implants de façon aussi efficace que lors d’un abord parapatellaire médian",
"BACKGROUND Knee arthroplasty is the treatment of choice for gonarthrosis . The development of minimally invasive surgery ( MIS ) requires assessing results based on the classical approaches and this is the purpose of our study . METHODS R and omized , prospect i ve study comparing two groups ; one underwent MIS ( 45 patients ) and the second one a classical approach ( 51 patients ) ; both groups were comparable . The following variables were assessed in the immediate postoperative period and at 4 and 8 years : blood loss , pain according to the VAS , flexion and extension and quality of life measured with the SF-36 . RESULTS In the immediate postoperative period we observed statistically significant differences ( p MIS approach in pain , hospital stay and blood loss . However , this was not observed at 4 and 8 years concerning pain , quality of life and range of motion . We observed an improvement in the functional scale and quality of life compared with the preoperative status , without any differences when both groups were compared . CONCLUSIONS The MIS technique results in a better immediate postoperative period , but no differences were seen in the choice of the approach 4 and 8 years after surgery",
"We conducted a prospect i ve , r and omized study to compare the short-term results of minimally invasive and computer-assisted total knee arthroplasty ( MICA-TKA ) with those of conventional total knee arthroplasty ( C-TKA ) for 12-month follow-up . A total of 87 subjects who met the inclusion and exclusion criteria of the study were prospect ively r and omized consecutively into two groups : the C-TKA group ( Group A , n = 44 ) and the MICA-TKA technique ( Group B , n = 43 ) . All the operations were performed by the same senior surgeon . Before surgery and at follow-up , patients were evaluated by the same observer . Tourniquet time as well as total blood loss was compared . Knee Society scores ( KSSs ) , Knee Society functional scores ( KSFSs ) , range of motion ( ROM ) , and radiographic results were assessed and reported preoperatively and at 12-month follow-up . Of these patients , 82 ( Group A 42 ; Group B 40 ) were available for 12-month evaluation . The two groups were found to be similar in terms of coronal mechanical axis . Similarly , the femoral rotational profile revealed that the prosthesis in Group A was implanted with similar internal rotation to Group B. The average blood loss in patients of Group B was significantly reduced as compared to patients of Group A. No significant difference was detected in terms of tourniquet time . Clinical results in Group B , with regard to ROMs and KSSs , as well as KSFSs were significantly superior to that in Group A. Based on the results obtained from this study , it is demonstrated that MICA-TKA leads to a similarly accurate restoration of leg alignment and component orientation compared to the C-TKA . Moreover , MICA-TKA produces superior clinical results to that of C-TKA . However , there is clearly a need for additional high- quality clinical trials with long-term follow-up to confirm the clinical benefits of MICA-TKA",
"BACKGROUND MIS TKA has been shown to offer a reduced in-patient stay , but no clinical difference at two years . Whilst there may be a benefit from earlier discharge , we need to ensure that there are no detrimental effects in the medium and long-term following MIS-TKA . To report the mid-term result from a prospect i ve r and omised controlled trial ( RCT ) comparing MIS-TKA with st and ard approach for TKA . METHODS Using knee score question naires , we collected patient reported outcome measures ( PROMs ) regarding pain and function . Sixty-six patients ( from an eligible cohort of 83 patients ) completed the mid-term postal follow-up . RESULTS There was no significant difference between groups for change in score from pre-operative to final follow-up in all three PROMs . Mean MIS and st and ard group improvement was : AKSS 53 and 51 ( p=0.7644 ) , OKS 15 and 16 ( p=0.2341 ) or WOMAC 15 and 15 ( p=0.9900 ) respectively . Both groups showed improvement in pain and function with no significant difference between groups . There was no difference between groups for revision due to malalignment at a mean six year follow-up . CONCLUSIONS In addition to the early benefits regarding hospital stay and complications , we have found that at a mean of six years there was no increase in malalignment , pain or function with MIS techniques",
"Abstract . The subvastus approach for total knee replacement was compared with the st and ard medial parapatellar approach in terms of postoperative knee scores and quadriceps strength . Two groups of patients with similar characteristics were formed : the first group consisted of 12 knees of 9 patients who were implanted via the medial parapatellar approach , and for the second group the subvastus approach was used in 10 knees of 10 patients . The groups ' knee scores and quadriceps strength were compared preoperatively and postoperatively at week 6 , months 3 and 6 . The knee scores improved similarly in both groups , but the change was more pronounced in the subvastus group . Quadriceps strength was greater in the subvastus group at postoperative week 6 , but there was no significant difference between the groups in months 3 and 6 . It was concluded that although the subvastus approach offers greater quadriceps strength in the early postoperative period , it has no significant advantage in this aspect over the medial parapatellar approach",
"This study presents a modification of the medial parapatellar surgical approach for total knee arthroplasty . This approach separates the vastus medialis muscle in the direction of its fibers beginning at the superior pole of the patella . One hundred eighteen consecutive total knee arthroplasty cases , performed by a single surgeon , were r and omized prospect ively to receive a medial parapatellar or midvastus muscle-splitting surgical approach . The frequency of lateral retinacular releases was recorded , patellar tilt and translation were measured , and quadriceps strength was tested . The midvastus muscle-splitting approach provided excellent exposure to all knees . Patellar stability and quadriceps strength were equivalent for the two approaches . It is concluded that the midvastus muscle-splitting approach is an efficacious alternative to the medial parapatellar approach for primary total knee arthroplasties ",
"A prospect i ve , r and omized study was performed to compare early clinical and radiographic outcomes of total knee arthroplasty using either st and ard or minimally invasive surgical approaches . Fifty-nine patients were r and omized into 3 groups : a st and ard median parapatellar incision ( n = 19 ) , a \" mini mid-vastus \" ( n = 20 ) , or a \" quad sparing \" group ( n = 20 ) . The procedures were performed by a single surgeon using similar perioperative protocol s at 1 hospital . Postoperatively , the quad sparing group demonstrated some statistically significant ( P postoperative complications or radiographic alignment of the implants . In conclusion , our study demonstrated that the quad sparing group had some improved early results without compromising safety or efficacy",
"BACKGROUND Despite intense debate regarding whether minimally invasive techniques for total knee arthroplasty improve clinical outcomes over st and ard techniques , few prospect i ve r and omized trials addressing this debate are available in the literature . We therefore design ed this multicenter study to assess the overall safety and effectiveness of a minimally invasive approach without the use of computer navigation in comparison with conventional knee arthroplasty . METHODS We prospect ively r and omized 134 patients ( 101 women and thirty-three men , with an average age of 70.1 years ) to undergo surgery for total knee arthroplasty with use of either minimally invasive knee instruments ( sixty-six patients ) or a st and ard approach ( sixty-eight patients ) . The follow-up period was one year . RESULTS On the basis of our sample size , no significant difference was detected between the groups in any of the relevant clinical areas assessed : total range of motion , Knee Society total and function scores , and visual analog scores for pain and activities of daily living . Patients who underwent minimally invasive surgery had a longer mean surgical time ( by 5.6 minutes ) and had less mean blood loss ( by 17 mL ) . Radiographic measurements demonstrated reliable implant positioning in both groups . Seven patients in each group had an adverse event related to their procedure . CONCLUSIONS On the basis of the numbers , no significant advantage to minimally invasive total knee arthroplasty over a conventional technique was observed . Greater sample sizes and a longer follow-up period are required to fully determine the long-term safety and efficacy of this minimally invasive surgical technique",
"QUESTIONS Does the PEDro scale measure only one construct ie , the method ological quality of clinical trials ? What is the hierarchy of items of the PEDro scale from least to most adhered to ? Is there any effect of year of publication of trials on item adherence ? Are PEDro scale ordinal scores equivalent to interval data ? DESIGN Rasch analysis of two independent sample s of 100 clinical trials from the PEDro data base scored using the PEDro scale . RESULTS Both sample s of PEDro data showed fit to the Rasch model with no item misfit . The PEDro scale item hierarchy was the same in both sample s , ranging from the most adhered to item r and om allocation , to the least adhered to item therapist blinding . There was no differential item functioning by year of publication . Original PEDro ordinal scores were highly correlated with transformed PEDro interval scores ( r = 0.99 ) . CONCLUSION The PEDro scale is a valid measure of the method ological quality of clinical trials . It is valid to sum PEDro scale item scores to obtain a total score that can be treated as interval level measurement and subjected to parametric statistical analysis",
"The purpose of this study was to determine whether the mini-midvastus approach to total knee arthroplasty ( TKA ) results in differences in quadriceps muscle strength as well as previously cited advantages in a double blind prospect i ve r and omized trial . Twenty-seven patients ( 54 TKAs ) scheduled for bilateral TKA were r and omized to undergo mini-midvastus approach on one knee and st and ard approach on the other . Incision lengths were the same . Postoperative strength was determined by isokinetic and isometric peak torque testing . Range of motion , pain Visual analog scale , side-preference , and gait analysis were assessed preoperatively and postoperatively . The only significant difference in strength testing was increased isokinetic and isometric extension torque at 3 weeks postoperatively for the mini-midvastus approach . No differences between the mini-midvastus and st and ard approach were observed for stride length , stance time , pain Visual analog scale , or knee range of motion . The mini-midvastus approach has limited benefit compared to the st and ard approach for TKA",
"Background While some clinical reports suggest minimally invasive surgical ( MIS ) techniques improve recovery and reduce pain in the first months after TKA , it is unclear whether it improves gait and thigh muscle strength . Questions / Purpose sWe hypothesized TKA performed through a mini-subvastus approach would improve subjective and objective and subjective function compared to a st and ard medial parapatellar approach 2 months after surgery . Methods We r and omized 40 patients into two groups using either the mini-subvastus approach or st and ard medial parapatellar approach . Patients were evaluated preoperatively and 2 months after surgery . We assessed subjective functional outcome and quality of life ( QOL ) using routine question naires ( SF-12 , Knee Society Score [ KSS ] , Knee Injury and Osteoarthritis Outcome Score [ KOOS ] , UCLA activity , patient milestone diary of activities ) . We determined isometric strength of the thigh muscles and assessed gait with a three-dimensional ( 3-D ) analysis during level walking and stair climbing . Results We observed improvements from preoperatively to 2 months postoperatively in functional scores , QOL , and knee kinematic and kinetic gait parameters during level and stair walking . Isometric quadriceps strength increased in both groups , although remaining lower when compared to sound limbs . We found no differences between the groups in KSS , SF-12 , KOOS , UCLA activity , patient milestone diary of activities , isometric quadriceps strength , or 3-D gait parameters , except a marginally higher speed of stair ascent in the MIS group . Conclusions Our observations suggest an MIS approach does not confer a substantial advantage in early function after TKA.Level of Evidence Level I , therapeutic study . See Instructions to Authors for a complete description of levels of evidence",
"In a prospect i ve r and omized double-blind study we compared the postoperative recovery and early results of two groups of 30 patients having total knee arthroplasty with minimally invasive techniques using either a mini-subvastus or a modified “ quadriceps-sparing ” approach . All knees were implanted with the same posterior-stabilized prosthesis ( LPS-Flex , Zimmer , Warsaw , IN ) by the same surgeon with the same dedicated set of downsized instruments . Epidural anesthesia with the same postoperative analgesia and rehabilitation protocol was used in all patients . Evaluation was performed preoperatively , postoperatively in the first week , and at 1 and 3 months . In five cases in the “ quadriceps- sparing ” group , the incision was extended a few cm to facilitate exposure . Tourniquet time , estimated blood loss , and postoperative pain were similar in the two groups . Active straight leg raising was achieved half a day earlier , on average , in the mini-subvastus group ( 1.9 vs 1.4 days ) . Average maximum active flexion was similar in the two groups at each interval , and reached 117 ° and 119 ° at 3 months for the mini-subvastus and “ quadriceps-sparing ” group , respectively . We believe there was no difference between the mini- subvastus and “ quadriceps-sparing ” approach in relation to short term recovery or early results . Level of Evidence : Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"BACKGROUND Minimally invasive surgery ( MIS ) has perceived advantages in the early post-operative stage such as reduced blood loss , decreased pain , earlier return to function and earlier discharge . The aim of our study was to confirm that longer term clinical outcome of TKA is not compromised when MIS is combined with computer assisted surgery . METHODS Eighty patients matched for age , gender , pre-operative Knee Society Score ( KSS ) and mechanical axis were prospect ively studied . Forty patients underwent minimally invasive computer assisted total knee arthroplasty ( MICATKA ) and 40 patients underwent conventional computer assisted TKA ( CATKA ) . Functional scores were determined at 6 weeks , 6 , 12 , 18 , and 24 months and 5 years post-surgery . Long-leg alignment views were obtained 3 months post-operatively . RESULTS KSSs in the short term were significantly better in the MICATKA group than in the CATKA group ( p Tourniquet-time was 58 min in the MICTKA group and 60 min in the CATKA group ( p=0.3 ) . Straight leg raise was achieved by day one in 93 % of the MICATKA group compared to 30 % of the CATKA group ( p Length of stay for the MICATKA group has a mean of 3.25 days and a mean of 6 days for the CATKA group ( p KSSs up to 2-years were significantly better in the MICTKA group ( p<0.001 ) . At 5-years there was no significant difference in KSSs ( p=0.46 ) in the MICATKA and CATKA groups . CONCLUSION We confirm that the use of navigation in minimally invasive TKA permits a number of early post-operative advantages and that longer-term functional outcome is not compromised with its usage . LEVEL OF EVIDENCE Level II",
"BACKGROUND The mini-subvastus and the mini-midvastus approaches are among the most common alternatives to the medial parapatellar approach for total knee arthroplasty . The purpose of this study was to compare the early clinical outcomes of these two approaches . METHODS In this prospect i ve , r and omized study of fifty-one patients who underwent bilateral total knee arthroplasty , the mini-subvastus approach was used in one knee and the mini-midvastus approach , in the contralateral knee . There were forty-two women and nine men who had a mean age of seventy years at the time of the index arthroplasties , and they were followed for two years postoperatively . Clinical outcome was assessed and compared with use of the Knee Society pain and function scores , the straight-leg-raising test , range of motion , and isokinetic strength testing . Operating time and blood loss for each approach were also compared . In addition , patients were surveyed concerning which knee they preferred . RESULTS Comparisons of postoperative Knee Society scores between both approaches at the time of the two-year follow-up did not yield a significant difference in outcome . Isokinetic strength testing at twelve weeks postoperatively revealed no significant differences in muscle strength , with a mean extensor peak torque-to-body weight ratio of 0.14 Nm/kg for both groups . No significant difference was found with respect to total blood loss , straight-leg-raising test , range of motion , or patient preference . There was no clinical ly relevant difference in operative times between the two approaches . CONCLUSIONS The minimally invasive subvastus and midvastus approaches for total knee arthroplasty were both associated with excellent short-term clinical results . Some surgeons believe that the subvastus approach completely avoids damage to the quadriceps mechanism and therefore would be associated with improved muscle function . This prospect i ve series did not identify a substantive difference between the two approaches . We believe that the decision between these surgical approaches should be based on surgeon preference and experience",
"We report the clinical and radiological results of a two- to three-year prospect i ve r and omised study which was design ed to compare a minimally-invasive technique with a st and ard technique in total knee replacement and was undertaken between January 2004 and May 2007 . The mini-midvastus approach was used on 50 patients ( group A ) and a st and ard approach on 50 patients ( group B ) . The mean follow-up in both groups was 23 months ( 24 to 35 ) . The functional outcome was better in group A up to nine months after operation , as shown by statistically significant differences in the mean function score , mean total score and the mean Oxford knee score ( all , p = 0.05 ) . Patients in group A had statistically significant greater early flexion ( p = 0.04 ) and reached their greatest mean knee flexion of 126.5 degrees ( 95 degrees to 135 degrees ) 21 days after operation . However , at final follow-up there was no significant difference in the mean maximum flexion between the groups ( p = 0.08 ) . Technical errors were identified in six patients from group A ( 12 % ) on radiological evaluation . Based on these results , the authors currently use minimally-invasive techniques in total knee replacement in selected cases only",
"A prospect i ve r and omized study was performed to compare the clinical and radiological results of primary total knee arthroplasties ( TKAs ) using a mini-midvastus approach or a mini-medial parapatellar approach in 134 patients . The mini-midvastus approach was used on 68 patients ( group A ) and the mini-medial parapatellar approach on 66 patients ( group B ) . All knees were implanted with the same posterior-stabilized prosthesis by the same surgeon ( T.-S.T. ) with the same set of downsized instruments . Mean follow-up in both groups was 30.5 months ( range , 24 - 48 months ) . Patients in group A achieved an active straight-leg raise and 90 ° of flexion significantly earlier ( P=.017 and P=.025 , respectively ) . However , no significant difference was detected between the groups with respect to range of movement and Knee Society scores at all the postoperative visits and at final follow-up ( all , P>.05 ) . In contrast , the tourniquet time was significantly longer in group A ( P=.015 ) , with a higher incidence of medialized tibial component ( P=.031 ) . We believe that the early clinical results are similar between the mini-midvastus and mini-medial parapatellar approach . The mini-medial parapatellar approach is easier to initially apply and provides better visualization for TKA",
"A prospect i ve , r and omized investigation compared early clinical outcomes of total knee arthroplasty ( TKA ) using conventional or minimally invasive surgical ( MIS ) approaches ( n = 44 ) . Outcome measures included isometric quadriceps and hamstrings strength , quadriceps activation , functional performance , knee pain , active knee range of motion , muscle mass , the Short Form-36 , and Western Ontario and McMaster University Osteoarthritis Index , assessed preoperatively and 4 and 12 weeks after TKA . Four weeks after TKA , the MIS group had greater hamstring strength ( P = .02 ) and quadriceps strength ( P = .07 ) , which did not translate to differences in other outcomes . At 12 weeks , there were no clinical ly meaningful differences between groups on any measure . Although MIS may lead to faster recovery of strength in patients undergoing TKA , there was no benefit on longer-term recovery of strength or functional performance",
"In a prospect i ve single-centre longitudinal r and omized controlled trial 116 patients were allocated to the sub-vastus approach , and 115 to the medial parapatellar approach . At one week follow-up , compared to baseline , range of motion , Knee Society ( KS ) global , KS knee , and KS pain scores were significantly better in the sub-vastus group . At the one year follow-up , WOMAC global and pain scores , SF36 physical function and role-physical scores , and EuroQol utility and pain score were significantly better in the sub-vastus group . The ease of exposure in the sub-vastus approach was significantly worse . There was no significant difference in length of stay or analgesia intake . The sub-vastus approach to total knee arthroplasty was more effective than a medial parapatellar approach at both one week and one year post-operatively , but surgeons reported a less easy exposure in the sub-vastus group",
"Background Although total knee replacement ( TKR ) has been proven a very successful treatment modality for the end-stage knee osteoarthritis ( OA ) in obese patients , the rehabilitation period often is long and painful . Minimal invasive surgery ( MIS ) has gained much attention in TKR promising fast and less painful recovery . However , little is known about the effectiveness of the technique in the obese adult population . Methods One hundred consecutive patients with body mass index ( BMI ) > 30 kg/m2 and tricompartmental knee OA were r and omly assigned to undergo either st and ard TKR ( 50 patients ) or MIS-TKR ( 50 patients ) . The patients were assessed clinical ly and radiologically before the procedure and at subsequent postoperative follow-up visits , until 2 years after the operation . Results Knee society function and pain scores were significantly higher in MIS group for 3 months following surgery . Patients after MIS had also lower levels of pain during hospitalization . Tourniquet time was on average 7 min longer during MIS-TKR ( p = 0.03 ) but operative time was almost equal in both groups ( p = 0.11 ) . No statistical significant difference was found between groups regarding the amount of blood loss ( p = 0.49 ) or incidence of allogeneic blood transfusion ( p = 0.27 ) . Active straight leg raising was achieved 2.2 days earlier , on average , after MIS-TKR ( p No severe complications or residual coronal and sagittal imbalance were identified . Component alignment was in normal limits and similar in both groups . In MIS group , higher BMI did not have a negative predictive effect on knee pain and function . Conclusions MIS is a reliable and safe option in obese patients undergoing TKR regardless the level of BMI . It is associated with improved early clinical outcome without sacrificing radiographic positioning of the implants",
"Background Since the medial parapatellar ( MPP ) approach in conventional TKA can cause patellar maltracking and anterior knee pain , some orthopaedic surgeons use the midvastus ( MV ) approach instead of the MPP approach to reduce patellar maltracking . Minimally invasive surgical ( MIS ) TKA has been developed to limit the damage to the surrounding muscle and reduce the necessity of patellar eversion during surgery . Thus , MIS TKA might be associated with proper patellar tracking and a low incidence of anterior knee pain . However , this presumption has not been confirmed . Questions / purpose sWe asked whether the incidence of patellar maltracking and anterior knee pain differed with the MV and MPP in association with MIS TKA . Methods We prospect ively followed 59 patients ( 60 knees ) treated with 60 primary cemented MIS TKAs from August 2009 to September 2010 . We r and omized the patients into two groups : 30 who had a limited MPP approach and 30 who had a mini-MV approach . We recorded the occurrence of anterior knee pain , patellar tilting , and subluxation . The minimum followup was 12 months ( mean , 18.03 months ; range , 12.00–25.08 months ) . Results We found no differences in anterior knee pain ( two of 30 , 7 % versus two of 30 , 7 % ) , mean patellar tilt ( 3.4º ± 2.9º versus 3.0 ± 2.3º ) , and mean patellar subluxation ( 1.5 ± 1.1 mm versus 1.1 ± 0.7 mm ) between the limited MPP and mini-MV groups , respectively . Conclusions MIS TKA using either the MPP or MV approach has a low incidence of patellar maltracking and anterior knee pain . Level of Evidence Level I , therapeutic study . See the Guidelines for Authors for a complete description of the levels of evidence",
"BACKGROUND Despite growing interest in minimally invasive surgery ( MIS ) techniques for total knee arthroplasty ( TKA ) , few r and omized controlled trials have compared MIS and conventional TKA using a combination of functional performance , knee pain , knee range of motion ( ROM ) , and surgical and radiographic outcomes . METHODS A prospect i ve , r and omized investigation comparing early outcomes of TKA using conventional or MIS approaches ( n = 44 ) . Patients were assessed preoperatively , 48 hours , 4 and 12 weeks postoperatively by blinded evaluators . Outcome measures included timed-up- and -go , 100-ft walk , knee pain , passive knee ROM , Knee Society Score , blood loss , tourniquet time , hospital length of stay , surgical complications , and radiographic outcomes . RESULTS No significant differences in functional performance , knee pain , knee ROM , surgical , or radiographic outcomes were observed between groups at 48 hours , 4 or 12 weeks postoperatively . CONCLUSION While surgical and radiographic outcomes were not compromised with MIS surgery , there were also no improvements in pain , ROM , or functional performance with MIS TKA",
"This prospect i ve r and omized study compared the clinical and radiological results of primary total knee arthropasty ( TKA ) using a mini-subvastus approach ( group I ; n = 35 ) or a st and ard approach ( group II ; n = 33 ) . A posterior-stabilized prosthesis was used in both groups by the same surgeon . Mean follow-up was 18 months ( range 14 − 26 months ) . Patients in group I lost less blood and experienced less pain 1 day post-operatively . They achieved an active straight leg raise earlier and underwent less lateral retinacular releases . Functional outcome and the range of knee movements were significantly better in group I up to 9 months post-operatively , but there was no significant difference between the groups at 1 year post-operatively or at final follow-up . Reduced access and visibility in group I prolonged the operation time and result ed in five technical errors on radiographic evaluation . Based on these results , the authors currently only use the mini-subvastus approach for minimally invasive TKA in selected cases",
"We performed a single-center , r and omized , double-blind study to compare muscle strength in patients who had undergone primary total knee arthroplasty ( TKA ) , performed using either a minimally invasive or a conventional surgical technique . We evaluated 30 knees in healthy age-matched subjects , 22 knees after conventional TKA ( conventional group ) , and 23 knees after minimally invasive surgery TKA ( MIS group ) . The Hospital for Special Surgery ( HSS ) score , Oxford knee score ( OKS ) , and isokinetic ( 60º/s ) muscle strength were evaluated the day before surgery and 3 , 6 , and 12 months after surgery . HSS and OKS improved significantly over time during follow-up ( p0.05 ) . The extensor peak torque ( EPT ) and flexor peak torque ( FPT ) improved significantly over time ( p no difference in FPT and the hamstring-to-quadriceps ratio between the groups . Although MIS patients had a significant deficit in extensor strength following TKA , compared with healthy controls , this approach offers a significant improvement in extensor muscle strength over conventional surgery . These results suggest that the MIS approach results in better outcomes with regard to maintaining extensor strength than the conventional surgical approach",
"Our study was conducted to compare radiographic alignments and functional outcomes with 2 approaches to minimal-incision total knee arthroplasty ( TKA ) : the minimal-incision medial parapatellar ( MP ) approach and the quadriceps-sparing ( QS ) approach with side-cutting instruments . Sixty patients ( 80 knees ) with primary osteoarthritis were r and omly assigned to receive MP or QS TKA . Postoperative alignment of the femoral component was significantly less valgus , and postoperative alignment of the tibial component was significantly more varus with the QS approach than with the MP approach . One tibial outlier and 3 femoral outliers were observed with QS TKA . The overall postoperative hip-knee-ankle axis was more varus , and surgical time was longer with QS TKA . Short-term isokinetic peak muscle torque , postoperative pain , and functional outcomes did not differ between the approaches",
"Purpose The aim of the study was to identify whether less soft tissue and muscle damage during surgery will allow faster recovery after total knee arthroplasty in comparison with the conventional technique . A limited medial parapatellar approach without tibial medial collateral ligament ( MCL ) desinsertion was compared with the conventional parapatellar approach . Methods Three hundred patients were r and omized either into the minimally invasive group ( MIS group ) or into the conventional group ( CON group ) . The evaluation was based on the Knee Society Score , range of motion , blood loss , period of hospitalization and postoperative hemoglobin level . Results The MIS group showed faster recovery with immediate postoperative full weight-bearing and shorter length of stay ( 5 vs 10 days ) . Comparable Knee Society Scores ( 87.5 vs 88 ) , function scores ( 90 ) and alignment ( 5.5 ° vs 5.2 ° ) between the CON and MIS group were observed at a follow-up of 24 months . No increase in operative times ( 52 vs 51 min tourniquet time ) or no complications were observed . Reduced blood loss was observed in the MIS group ( 590 vs 989 ml ) . Conclusion The MCL sparing limited medial parapatellar approach allows good surgical exposure , easy extension proximally if necessary , contained closure after surgery with less bleeding , faster recovery , full weight-bearing without aid and most importantly no radiological malalignment . Level of evidence Therapeutic study , Level II",
"Comparisons between mini-midvastus ( mMV ) and mini-medial parapatellar approach ( mMPP ) for total knee arthroplasty ( TKA ) have reported variable results . We compared two approaches with minimum two year follow up . Forty consecutive patients who underwent staged bilateral TKA were prospect ively r and omized for mMPP approach in one knee and mMV approach in the other . Clinical parameters ( muscle strength , pain , ROM , Knee Society Score ) and surgic.l parameters ( duration of surgery , blood loss , lateral releases ) were assessed at 2 , 6 , 12 weeks and 6 , 12 , 24 months postoperatively . Clinical outcomes revealed inconsistent pattern of differences at various intervals . Surgical outcomes were not different . There were no major differences in outcomes between the two approaches . We recommend someone use surgical approach with which they are most familiar",
"BACKGROUND Studies on minimally invasive computer-assisted total knee arthroplasty ( MICA-TKA ) have shown promising results , but are limited by short follow-up . The purpose of this study was to compare the midterm radiographic features and functional outcomes between patients who underwent MICA-TKA and conventional TKA . METHODS A total of 108 patients who were r and omized to undergo MICA-TKA or conventional TKA during 2004 and 2005 were contacted for a prospect i ve follow-up review . Patients who were lost to contact , have passed away , or declined to participate in the study were excluded . Objective functional measurements and radiographs were obtained for assessment . RESULTS By the time of this study , 2 patients from the conventional group had undergone revision TKA , one due to infection and one due to aseptic loosening . A total of 67 patients ( 62.04 % ) were followed up for an average period of 9.07 years ( 8.51 - 9.61 years ) . At follow-up , functional scores were comparable between the 2 groups . No significant intergroup differences were found in mechanical knee alignment and component placement angle in the coronal views . No statistical or clinical significance were noticed in radiographic signs of component loosening . CONCLUSIONS MICA-TKA provided similar clinical , functional , and radiographic outcomes compared with conventional TKA after an average of 9-year follow-up . This technique can be used to exploit its short-term advantages without compromising midterm outcomes",
"BACKGROUND / PURPOSE Quadriceps-sparing minimally invasive total knee arthroplasty ( TKA ) has been proposed to limit surgical dissection without compromising surgical outcome . We conducted a prospect i ve and r and omized study to compare the outcomes of patients who underwent quadriceps-sparing TKA with the outcomes of those who underwent st and ard medial parapatellar TKA , after a 2-year follow-up period . METHODS Eighty primary TKA procedures that were to be performed in 60 osteoarthritis patients were r and omly assigned to either a quadriceps-sparing ( 40 knees ) or a st and ard medial parapatellar ( 40 knees ) group . All surgeries were design ed to set the prosthesis with a femoral component alignment of 7 ° valgus and a tibial component alignment that was perpendicular to the tibial shaft . Surgical time and tourniquet time were recorded . Outcome variables included knee function , as defined by a hospital for special surgery knee score ; quadriceps muscle strength , which was measured by an isokinetic dynamometer ; pain , as indicated on a visual analog scale ; prosthetic position , which was measured on plain radiograph ; and range of motion . RESULTS Patients who underwent the 38 quadriceps-sparing and 37 st and ard TKA procedures completed the 2-year follow-up period without any infection or revision . The mean surgical time and tourniquet time were significantly longer in the quadriceps-sparing group . The mean peak quadriceps muscle strength , hamstring muscle strength , normalized muscle balance ( hamstring/quadriceps ratio ) , pain score , function score , and range of motion were comparable in both groups at 2 months and 2 years . In the quadriceps-sparing group , both the femoral and the tibial components were significantly more varus-deviated from the expected position . CONCLUSIONS Patients undergoing quadriceps-sparing and st and ard medial parapatellar TKA had comparable outcomes for quadriceps muscle strength , hamstring-quadriceps balance , and knee function ; however , the quadriceps-sparing TKA was more time consuming surgically and result ed in a less accurate prosthesis position",
"The mini-midvastus ( MV ) approach to total knee arthroplasty ( TKA ) minimizes damage to the extensor mechanism ; however , the mini-subvastus ( SV ) approach is design ed to avoid such damage . Quadriceps weakness following TKA can have a significant impact on the activities of daily living , particularly st and -to-sit down ( STSD ) and sit-to-st and up ( STSU ) activities . Fifty-three subjects diagnosed with primary osteoarthritis and scheduled to undergo TKA were r and omized to receive an MV or SV surgical approach and were given identical postoperative orders . Compared with age-matched controls , the SV group had a quicker return of normal peak knee extension moment during STSU , whereas the MV group had a quicker return of normal movement patterns in hip , knee , and ankle parameters during STSD yet represented the higher functioning subjects as more MV subjects had difficulty completing the task as instructed . Considering both movements are required for daily living , neither surgical group was found to have a significant advantage over the other in functional outcome through 6 months post-TKA",
"Background Less invasive dissection of the extensor apparatus , one of the aspects of minimally invasive surgical ( MIS ) TKA , might result in less reduction of postoperative quadriceps strength . However , it is unclear whether MIS is associated with less strength reduction . Questions / purpose sWe asked whether knee strength ( extensor or flexor torque ) would be greater in patients having a MIS TKA compared with patients having a st and ard TKA and whether knee scores , alignment , ROM , tourniquet and operating times , and hospital length of stay were improved . Methods We prospect ively recruited 52 patients awaiting MIS or st and ard TKA , matched for age , weight , height , BMI , sex , and surgically treated side , but not r and omized . Isokinetic tests were performed preoperatively and postoperatively to obtain peak values of extensor and flexor torque . Postoperative-to-preoperative ratios and the extensor-flexor torque ratio also were calculated . Results Mean baseline extensor torques were 57 Nm and 53 Nm for MIS and st and ard TKAs , respectively . At 8 weeks postoperatively , absolute values of the mean postoperative knee extensor torque also were similar : 47 and 45 Nm for patients with MIS and st and ard TKAs , respectively . The postoperative-to-preoperative ratios were 0.8 for extensor and flexor torque in both groups . The extensor-flexor torque ratios were similar between groups . Conclusions Our data suggest a less invasive dissection of the extensor apparatus involved in MIS TKA does not enhance postoperative quadriceps strength . Level of Evidence Level III , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence"
] | 411627f2-06ff-11f0-808a-c43d1ab1c353 |
Background Chronic low back pain ( CLBP ) is a persistent disabling condition with rising significant healthcare , social and economic costs . Current research supports the use of exercise-based treatment approaches that encourage people with CLBP to assume a physically active role in their recovery . While international clinical guidelines and systematic review s for CLBP support supervised group exercise as an attractive first-line option for treating large numbers of CLBP patients at low cost , barriers to their delivery include space and time restrictions in healthcare setting s and poor patient attendance . The European Clinical Guidelines have identified the need for research in the use of brief/minimal contact self-activation interventions that encourage participation in physical activity for CLBP . Walking may be an ideally suited form of individualized exercise prescription as it is easy to do , requires no special skills or facilities , and is achievable by virtually all ages with little risk of injury , but its effectiveness for LBP is unproven . Methods and design This study will be an assessor-blinded r and omized controlled trial that will investigate the difference in clinical effectiveness and costs of an individualized walking programme and a supervised general exercise programme compared to usual physiotherapy , which will act as the control group , in people with chronic low back pain . A sample of 246 patients will be recruited in Dublin , Irel and through acute general hospital outpatient physiotherapy departments that provide treatment for people with CLBP . Patients will be r and omly allocated to one of the three groups in a concealed manner . The main outcomes will be functional disability , pain , quality of life , fear avoidance , back beliefs , physical activity , satisfaction and costs , which will be evaluated at baseline , and 3 , 6 and 12 months [ follow-up by pre-paid postage ] . Qualitative telephone interviews and focus groups will be embedded in the research design to obtain feedback about participants ' experiences of the interventions and trial participation , and to inform interpretation of the quantitative data . Planned analysis will be by intention to treat ( quantitative data ) and thematic analysis ( qualitative data ) Discussion The trial will evaluate the effectiveness of a walking programme and a supervised general exercise programme compared to usual physiotherapy in people with CLBP.Trial registration Current controlled trial IS RCT | [
"Abstract Objective To estimate the effect of adding exercise classes , spinal manipulation delivered in NHS or private premises , or manipulation followed by exercise to “ best care ” in general practice for patients consulting with back pain . Fig 1 Progress of the UK BEAM trial Design Pragmatic r and omised trial with factorial design . Setting 181 general practice s in Medical Research Council General Practice Research Framework ; 63 community setting s around 14 centres across the United Kingdom . Participants 1334 patients consulting their general practice s about low back pain . Main outcome measures Scores on the Rol and Morris disability question naire at three and 12 months , adjusted for centre and baseline scores . Results All groups improved over time . Exercise improved mean disability question naire scores at three months by 1.4 ( 95 % confidence interval 0.6 to 2.1 ) more than “ best care . ” For manipulation the additional improvement was 1.6 ( 0.8 to 2.3 ) at three months and 1.0 ( 0.2 to 1.8 ) at 12 months . For manipulation followed by exercise the additional improvement was 1.9 ( 1.2 to 2.6 ) at three months and 1.3 ( 0.5 to 2.1 ) at 12 months . No significant differences in outcome occurred between manipulation in NHS premises and in private premises . No serious adverse events occurred . Conclusions Relative to “ best care ” in general practice , manipulation followed by exercise achieved a moderate benefit at three months and a small benefit at 12 months ; spinal manipulation achieved a small to moderate benefit at three months and a small benefit at 12 months ; and exercise achieved a small benefit at three months but not 12 months",
"Background For high-risk individuals and their healthcare providers , finding the right balance between promoting physical activity and minimizing the risk of adverse events can be difficult . More information on the prevalence and influence of adverse events is needed to improve providers ' ability to prescribe effective and safe exercise programs for their patients . Methods This study describes the type and severity of adverse events reported by participants with cardiovascular disease or at-risk for cardiovascular disease that occurred during an unsupervised , home-based walking study . This multi-site , r and omized controlled trial tested the feasibility of a diet and lifestyle activity intervention over 1.5 years . At month 13 , 274 eligible participants ( male veterans ) were recruited who were ambulatory , BMI > 28 , and reporting one or more cardiovascular disease risk factors . All participants attended five , face-to-face dietitian-delivered counseling sessions during the six-month intervention . Participants were r and omized to three study arms : 1 ) time-based walking goals , 2 ) simple pedometer-based walking goals , and 3 ) enhanced pedometer-based walking goals with Internet-mediated feedback . Two physicians verified adverse event symptom coding . Results Enrolled participants had an average of five medical comorbidities . During 1110 person months of observation , 87 of 274 participants reported 121 adverse events . One serious study -related adverse event ( atrial fibrillation ) was reported ; the individual resumed study participation within three days . Non-serious , study related adverse events made up 12 % of all symptoms – predominantly minor musculoskeletal events . Serious , non- study related adverse events represented 32 % of all symptoms while non-serious , non- study related adverse events made up 56 % of symptoms . Cardiovascular disease events represented over half of the non- study related adverse event symptoms followed by musculoskeletal complaints . Adverse events caused 50 temporary suspensions averaging 26 days in duration before physician medical clearance was obtained to resume walking . Conclusion Men at high risk for adverse cardiovascular events can safely be advised to start a progressive walking program . Results suggest that minor to serious medical problems unrelated to exercise are a major barrier to walking adherence . Helping individuals with chronic illness return to physical activity quickly but safely after an adverse event is an important component of any physical activity intervention targeting this population",
"Background Evidence supports the use of exercise for chronic low back pain ( CLBP ) ; however , adherence is often poor due to ongoing pain . Auricular acupuncture is a form of pain relief involving the stimulation of points on the outer ear corresponding with specific body parts . It may be a useful adjunct to exercise in managing CLBP ; however , there is only limited evidence to support its use with this patient group . Methods / Design This study was design ed to test the feasibility of an assessor-blind r and omised controlled trial which assess the effects on clinical outcomes and exercise adherence of adding manual auricular acupuncture to a personalised and supervised exercise programme ( PEP ) for CLBP . No sample size calculation has been carried out as this study aims to identify CLBP referral rates within the catchment area of the study site . The research ers aim to recruit four cohorts of n = 20 participants to facilitate a power analysis for a future r and omised controlled trial . A computer generated r and om allocation sequence will be prepared central ly and used to allocate participants by cohort to one of the following interventions : 1 ) six weeks of PEP plus manual auricular acupuncture ; 2 ) six weeks of PEP alone . Both groups will also complete a further six weeks of self-paced exercise with telephone follow-up support . In addition to a baseline and exit question naire at the beginning and end of the study , the following outcomes will be collected at baseline , and after 7 , 13 and 25 weeks : pain frequency and bothersomeness , back-specific function , objective assessment and recall of physical activity , use of analgesia , perceived self-efficacy , fear avoidance beliefs , and beliefs about the consequences of back pain . Since this is a feasibility study , significance tests will not be presented , and treatment effects will be represented by point estimates and confidence intervals . For each outcome variable , analysis of covariance will be performed on the data , conditioning on the baseline value . Discussion The results of this study investigating the adjuvant effects of auricular acupuncture to exercise in managing CLBP will be used to inform the design of a future multi-centre r and omised controlled trial . Trial Registration Current Controlled Trials IS RCT N94142364",
"Background The CONSORT statement is intended to improve reporting of r and omised controlled trials and focuses on minimising the risk of bias ( internal validity ) . The applicability of a trial ’s results ( generalisability or external validity ) is also important , particularly for pragmatic trials . A pragmatic trial ( a term first used in 1967 by Schwartz and Lellouch ) can be broadly defined as a r and omised controlled trial whose purpose is to inform decisions about practice . This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability . Methods At two , two-day meetings held in Toronto in 2005 and 2008 , we review ed the CONSORT statement and its extensions , the literature on pragmatic trials and applicability , and our experiences in conducting pragmatic trials . Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials : the background , participants , interventions , outcomes , sample size , blinding , participant flow , and generalisability of the findings . These extensions are presented , along with illustrative examples of reporting , and an explanation of each extension . Adherence to these reporting criteria will make it easier for decision makers to judge how applicable the results of r and omised controlled trials are to their own conditions . Empirical studies are needed to ascertain the usefulness and comprehensiveness of these CONSORT checklist item extensions . In the meantime we recommend that those who support , conduct , and report pragmatic trials should use this extension of the CONSORT statement to facilitate the use of trial results in decisions about health care . Pragmatic trials are design ed to inform decisions about practice , but poor reporting can reduce their usefulness . The CONSORT and Practihc groups describe modifications to the CONSORT guidelines to help readers assess the applicability of the",
"PURPOSE The purpose of this study was to compare the step values of multiple br and s of pedometers over a 24-h period . The following 13 electronic pedometers were assessed in the study : Accusplit Alliance 1510 ( AC ) , Freestyle Pacer Pro ( FR ) , Colorado on the Move ( CO ) , Kenz Lifecorder ( KZ ) , New-Lifestyles NL-2000 ( NL ) , Omron HJ-105 ( OM ) , Oregon Scientific PE316CA ( OR ) , Sportline 330 ( SL330 ) and 345 ( SL345 ) , Walk4Life LS 2525 ( WL ) , Yamax Skeletone EM-180 ( SK ) , Yamax Digi-Walker SW-200 ( YX200 ) , and the Yamax Digi-Walker SW-701 ( YX701 ) . METHODS Ten males ( 39.5 + /- 16.6 yr , mean + /- SD ) and 10 females ( 43.3 + /- 16.6 yr ) ranging in BMI from 19.8 to 35.4 kg.m-2 wore two pedometers for a 24-h period . The criterion pedometer ( YX200 ) was worn on the left side of the body , and a comparison pedometer was worn on the right . Steps counted by each device were recorded at the end of the day for each of the thirteen pedometers . RESULTS Subjects took an average of 9244 steps.d-1 . The KZ , YX200 , NL , YX701 , and SL330 yielded mean values that were not significantly different from the criterion . The FR , AC , SK , CO , and SL345 significantly underestimated steps ( P overestimated steps ( P underestimated by 25 % whereas others overestimated by 45 % . CONCLUSION The KZ , YX200 , NL , and YX701 appear to be suitable for most research purpose s. Given the potential for pedometers in physical activity research , it is necessary that there be consistency across studies in the measurement of \" steps per day .",
"Abstract Objective : To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities . Design : R and omised controlled trial of progressive exercise programme compared with usual primary care management . Patients ' preferences for type of management were elicited independently of r and omisation . Participants : 187 patients aged 18 - 60 years with mechanical low back pain of 4 weeks to 6 months ' duration . Interventions : Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups , stretching exercises , relaxation session , and brief education on back care . A cognitive-behavioural approach was used . Main outcome measures : Assessment s of debilitating effects of back pain before and after intervention and at 6 months and 1 year later . Measures included Rol and disability question naire , Aberdeen back pain scale , pain diaries , and use of healthcare services . Results : At 6 weeks after r and omisation , the intervention group improved marginally more than the control group on the disability question naire and reported less distressing pain . At 6 months and 1 year , the intervention group showed significantly greater improvement in the disability question naire score ( mean difference in changes 1.35 , 95 % confidence interval 0.13 to 2.57 ) . At 1 year , the intervention group also showed significantly greater improvement in the Aberdeen back pain scale ( 4.44 , 1.01 to 7.87 ) and reported only 378 days off work compared with 607 in the control group . The intervention group used fewer healthcare re sources . Outcome was not influenced by patients ' preferences . Conclusions : The exercise class was more clinical ly effective than traditional general practitioner management , regardless of patient preference , and was cost effective . Key messages Patients with back pain need to return to normal activities as soon as possible but are often afraid that movement or activity may be harmful An exercise programme led by a physiotherapist in the community and based on cognitive-behavioural principles helped patients to cope better with their pain and function better even one year later Patients ' preferences for type of management did not affect outcome Patients in the intervention group tended to use fewer healthcare re sources and took fewer days off work This type of exercise programme should be more widely",
"OBJECTIVE To evaluate a progressive fitness programme for patients with chronic low back pain . DESIGN Single blind r and omised controlled trial . Assessment s were carried out before and after treatment by an observer blinded to the study and included a battery of vali date d measures . All patients were followed up by postal question naire six months after treatment . SETTING Physiotherapy department of orthopaedic hospital . SUBJECTS 81 patients with chronic low back pain referred from orthopaedic consultants for physiotherapy . The patients were r and omly allocated to a fitness programme or control group . INTERVENTION Both groups were taught specific exercises to carry out at home and referred to a back-school for education in back care . Patients allocated to the fitness class attended eight exercise classes over four weeks in addition to the home programme and backschool . RESULTS Significant differences between the groups were shown in the changes before and after treatment in scores on the Oswestry low back pain disability index ( P pain reports ( sensory P self efficacy reports ( P walking distance ( P general health question naire or question naire on pain locus of control . A benefit of about 6 percentage points on the disability index was maintained by patients in the fitness group at six months . CONCLUSION There is a role for supervised fitness programmes in the management of moderately disabled patients with chronic low back pain . Further clinical trials , however , need to be established in other centres to confirm these findings",
"Background A significant proportion of Europeans do not meet the recommendations for 30 mins of physical activity 5 times per week . Whether lower frequency , moderate intensity exercise alters cardiovascular disease ( CVD ) risk has received little attention . This study examined the effects of 45 minutes self-paced walking , 2 d · wk-1 on aerobic fitness , blood pressure ( BP ) , body composition , lipids and C-Reactive Protein ( CRP ) in previously sedentary civil servants . Methods 37 subjects ( 24 women ) aged 41.5 ± 9.3 years were r and omly assigned to either two 45 minute walks per week ( walking group ) or no training ( control group ) . Aerobic fitness , body composition , blood pressure ( BP ) , CRP and lipoprotein variables were measured at baseline and following 8 weeks . Steps counts were measured at baseline and during weeks 4 and 8 of the intervention . Results Compared to the control group , the walking group showed a significant reduction in systolic BP and maintained body fat levels ( P HRmax , improves activity levels , reduces systolic BP and prevents an increase in body fat in previously sedentary adults . This walking prescription , however , failed to induce significant improvements in other markers of cardiovascular disease risk following eight weeks of training",
"A small-scale exploratory cross-sectional survey investigated the current use of a range of exercise therapy approaches for low back pain ( LBP ) by outpatient physiotherapists in the acute hospital setting in the Republic of Irel and , where the majority of publicly funded treatment is delivered . Of the 120 postal question naires distributed to 24 physiotherapy departments , 87 were returned ( 72.5 % response rate ) . The results showed specific spinal stabilization exercises were the most popular exercise therapy for acute ( 39 % ; n = 35 ) and chronic ( 51 % ; n = 48 ) LBP , followed by the McKenzie approach ( acute LBP ( ALBP ) 35.6 % ; n = 32 : chronic LBP ( CLBP ) 17 % ; n = 16 ) , and abdominal exercise ( ALBP 11.1 % ; n = 10 : CLBP 9.6 % ; n = 9 ) . The most popular forms of exercise therapy used by outpatient physiotherapists in acute hospital setting s in Irel and lack support from evidence -based clinical guidelines , and further large-scale high quality r and omized controlled trials of these approaches are warranted . Further research should also establish the use of exercise therapy and attitudes to clinical guidelines of physiotherapists in other countries and healthcare setting",
"PURPOSE To compare the effects of different patterns of regular brisk walking on fitness , risk factors for cardiovascular disease , and psychological well-being in previously sedentary adults . METHODS Twenty-one subjects ( 14 women ) , aged 44.5 + /- 6.1 yr ( mean + /- SD ) were r and omly assigned to two different , 6-wk programs of brisk walking in a cross-over design , with an interval of 2 wk . One program comprised one 30-min walk per day , 5 d.wk(-1 ) ( long bout ) and the other three 10-min walks per day , also 5 d.wk(-1 ) ( short bouts ) . All walking was at 70 - 80 % of predicted maximal heart rate . Maximal oxygen uptake ( (.)VO(2max ) ) , body composition , resting arterial blood pressure , fasting plasma lipoprotein variables , and psychological parameters were assessed before and after each program . RESULTS Overall , subjects completed 88.2 + /- 1.1 % and 91.3 + /- 4.1 % of prescribed total walking time in the short- and long-bout programs , respectively . Both programs increased plasma concentrations of high-density lipoprotein cholesterol , and decreased concentrations of triacylglycerol and total cholesterol ( all body mass , but the sum of four skinfolds , waist circumference , and hip circumference were decreased after both walking programs ( all P Predicted (.)VO(2max ) increased with both programs ( P tension/anxiety ( P brisk walking accumulated throughout the day are at least as effective as one continuous bout of equal total duration in reducing cardiovascular risk and improving aspects of mood in previously sedentary individuals",
"BACKGROUND AND PURPOSE Walking is an important functional activity and the shuttle walking test has been shown to be a useful test for patients with chronic airways obstruction and heart failure . The test has been used in low back pain research over recent years and has increasingly been used as an outcome measure to investigate treatment efficacy in patients with low back pain . The aim of the present study was to determine the reliability and responsiveness of the shuttle walking test within a group of patients with low back pain ( with or without sciatica ) . METHOD Reliability of the shuttle walking test was determined on a group of patients with low back pain ( n = 44 ) using the Bl and and Altman ( 1986 ) limits of agreement and the intraclass correlation coefficient ( ICC ) . Responsiveness was assessed using the st and ardized effect size . The mean distance walked within a patient population ( n = 337 ) was compared with an age- and sex-matched group of healthy subjects ( n = 122 ) . RESULTS The shuttle walking test obtained an ICC score of 0.99 , whereas the limits of agreement test gave a mean difference of 2.5 m with upper and lower limits of agreement of 52 m and -47 m , respectively . Patients undertaking fitness training reached an effect size of 1.2 compared to a control group of 0.23 and 0.94 for a group undergoing various orthopaedic treatments . CONCLUSIONS The present study has shown that the shuttle walking test is a reliable and responsive test within a group of patients with low back pain , with or without sciatica . It is simple to administer and provides a quick method of measuring one aspect of a patient 's physical function",
"OBJECTIVE To evaluate the short-term effect of physical exercise and a cognitive intervention in low back pain . DESIGN R and omized controlled trial . SUBJECTS Ninety-three patients sick-listed for 8 - 12 weeks for sub-acute low back pain were r and omized to an exercise regime ( n = 30 ) , a cognitive intervention ( n = 34 ) or a control group ( n = 29 ) . METHODS Primary outcome measures were pain , disability , sick-listing and satisfaction with care . Secondary outcome measures were self-efficacy for pain and for function , fear-avoidance beliefs , emotional distress , generic health status and life satisfaction . RESULTS Eighteen percent of subjects dropped out . Drop-out was most frequent in the exercise group . At 18 weeks after inclusion fear-avoidance beliefs were reduced in both intervention groups . The cognitive group demonstrated significant improvement in disability , self-efficacy for pain , emotional distress , general health and life satisfaction . Patients in the exercise group were significantly more satisfied with the treatment , and patients following the exercise protocol reduced pain significantly . No effect on sick-listing was seen . CONCLUSION Cognitive intervention improved disability and may be feasible for most patients sick-listed in the sub-acute phase . Physical exercise reduced patients ' symptoms , but requires high motivation by patients . Despite positive effects in intervention groups on variables considered as negative prognostic factors for long-term disability and sickness absence , interventions had no effect on sick-listing",
"Study Design . A subgroup analysis of patient outcomes from a r and omized controlled trial comparing a Back to Fitness program with usual general practitioner care . Objectives . To test whether patients with high scores on measures of fear-avoidance and distress/depression benefit the most . Summary of Background Data . A fitness program , ongoing since the 1980s , was developed for use in the community and has been shown to be effective in reducing disability . Detailed analyses are needed to identify patient groups who benefit . Recent evidence points to the potentially important role of fear , distress , and depression . Method . Data from 98 patients allocated to normal general practitioner care and 89 patients allocated to a group exercise program were analyzed after categorizing baseline scores on fear-avoidance beliefs ( high/low ) and distress/depression ( at risk/normal ) . The main outcome measure was the Rol and Disability Question naire . Outcomes were compared between the intervention and control groups at 6 weeks , 6 months , and 12 months . Results . High fear-avoiders fared significantly better in the exercise program than in usual general practitioner care at 6 weeks and at 1 year . Low fear-avoiders did not . Patients who were distressed or depressed were significantly better off at 6 weeks , but the benefits were not maintained long-term . Conclusion . Patients with high levels of fear-avoidance beliefs could significantly benefit from the Back to Fitness program . The benefits of the exercise program for patients with high levels of distress/depression appear to be short-term only . Average attendance was only 4 to 5 classes , which may not be sufficient for more recalcitrant cases . Further research is indicated",
"Study Design . A multicenter , r and omized , single‐blinded controlled trial with 1‐year follow‐up . Objectives . To evaluate the efficiency of progressively grade d medical exercise therapy , conventional physiotherapy , and self‐exercise by walking in patients with chronic low back pain . Summary and Background Data . Varieties of medical exercise therapy and conventional physiotherapy are considered to reduce symptoms , improve function , and decrease sickness absence , but this opinion is controversial . Methods . Patients with chronic low back pain or radicular pain sick‐listed for more than 8 weeks and less than 52 weeks ( Sickness Certificate II ) were included . The treatment lasted 3 months ( 36 treatments ) . Pain intensity , functional ability , patient satisfaction , return to work , number of days on sick leave , and costs were recorded . Results . Of the 208 patients included in this study , 71 were r and omly assigned to medical exercise therapy , 67 to conventional physiotherapy , and 70 to self‐exercise . Thirty‐three ( 15.8 % ) patients dropped out during the treatment period . No difference was observed between the medical exercise therapy and conventional physiotherapy groups , but both were significantly better than self‐exercise group . Patient satisfaction was highest for medical exercise therapy . Return to work rates were equal for all 3 intervention groups at assessment 15 months after therapy was started , with 123 patients were back to work . In terms of costs for days on sick leave , the medical exercise therapy group saved 906,732 Norwegian Kroner ( NOK ) ( $ 122,531.00 ) , and the conventional physiotherapy group saved NOK 1,882,560 ( $ 254,200.00 ) , compared with the self‐exercise group . Conclusions . The efficiency of medical exercise therapy and conventional physiotherapy is shown . Leaving patients with chronic low back pain untampered poses a risk of worsening the disability , result ing in longer periods of sick leave",
"Study Design . A prospect i ve cohort . Objective . The aim of this study was to compare the responsiveness of a patient specific outcome measure with the Oswestry Disability Index v2.1 ( ODI ) and the Rol and and Morris Disability Question naire ( RMDQ ) for patients with mild to moderate subacute and chronic low back pain . Summary of Background Data . Patient specific outcome measures allow individuals to select and rate the relative importance of activities they consider of greatest relevance . However , there is a paucity of research reporting the responsiveness of these measures for patient with back pain . Methods . Two hundred and one patients were assessed at baseline and 12 months using the patient specific activity question naire ( PSAQ ) , the ODI , the RMDQ , and a transition rating scale . The latter was used to categorize patients into 3 groups ( better , same or worse ) . Effect size statistics , receiver operating characteristic curves and 1-way between groups analysis of variance were used in the analysis . Results . All instruments were able to detect improvements in back pain as measured by the transition rating scale . In this improved group effect sizes were large for the PSAQ ( 1.08 to 1.31 ) and ODI ( −0.88 to −1.00 ) but only moderate for the RMDQ ( −0.70 to −0.74 ) . In the deteriorated group effect sizes were moderate to large for the ODI ( 0.61 to 1.16 ) and RMDQ ( 0.69 to 1.25 ) , but small for the PSAQ ( −0.16 to −0.26 ) . The areas under receiver operator characteristic curves for the ODI , PSAQ , and RMDQ , respectively were : 0.75 ( 95 % CI 0.68 to 0.82 ) , 0.75 ( 95 % CI 0.68 to 0.82 ) and 0.69 ( 95 % CI 0.61 to 0.76 ) . Conclusion . The PSAQ was highly responsive to change in patients who report improvement in back symptoms but unlike the ODI and RMDQ was unable to detect deterioration . Overall , the ODI was more responsive than either the PSAQ or the RMDQ",
"Study Design . A multicenter assessor-blinded r and omized clinical trial was conducted . Objectives . To investigate the difference in effectiveness of manipulative therapy and interferential therapy for patients with acute low back pain when used as sole treatments and in combination . Summary of Background Data . Both manipulative therapy and interferential therapy are commonly used treatments for low back pain . Evidence for the effectiveness of manipulative therapy is available only for the short-term . There is limited evidence for interferential therapy , and no study has investigated the effectiveness of manipulative therapy combined with interferential therapy . Methods . Consenting subjects ( n = 240 ) recruited following referral by physicians to physiotherapy departments in the ( government-funded ) National Health Service in Northern Irel and were r and omly assigned to receive a copy of the Back Book and either manipulative therapy ( MT ; n = 80 ) , interferential therapy ( IFT ; n = 80 ) , or a combination of manipulative therapy and interferential therapy ( CT ; n = 80 ) . The primary outcome was a change in functional disability on the Rol and Morris Disability Question naire . Follow-up question naires were posted at discharge and at 6 and 12 months . Results . The groups were balanced at baseline for low back pain and demographic characteristics . At discharge all interventions significantly reduced functional disability ( Rol and Morris scale , MT : −4.53 ; 95 % CI , −5.7 to −3.3 vs. IFT : −3.56 ; 95 % CI , −4.8 to −2.4 vs. CT : −4.65 ; 95 % CI , −5.8 to −3.5 ; P = 0.38 ) and pain ( McGill question naire , MT : −5.12 ; 95 % CI , −7.7 to −2.5 vs. IFT : −5.87 ; 95 % CI , −8.5 to −3.3 vs. CT : −6.64 ; 95 % CI , −9.2 to −4.1 ; P = 0.72 ) and increased quality of life ( SF-36 Role-Physical , MT : 28.6 ; 95 % CI , 18.3 to 38.9 vs. IFT : 31.4 ; 95 % CI , 21.2 to 41.5 vs. CT : 30 ; 95 % CI , 19.9 to 40 ; P = 0.93 ) to the same degree and maintained these improvements at 6 and 12 months . No significant differences were found between groups for reported LBP recurrence , work absenteeism , medication consumption , exercise participation , or healthcare use at 12 months ( P > 0.05 ) . Conclusions . For acute low back pain , there was no difference between the effects of a combined manipulative therapy and interferential therapy package and either manipulative therapy or interferential therapy alone",
"Purpose . To compare a group exercise programme known as the Back to Fitness programme with individual physiotherapy for patients with non-specific low back pain from a material ly deprived area . Method . This was a r and omized controlled trial including 237 physiotherapy patients with back pain lasting more than six weeks . Participants were allocated to either the Back to Fitness programme or to individual physiotherapy , and followed up at three months and 12 months after r and omization . The main outcome measure was the Rol and Disability Question naire . Secondary measures were : SF12 , EQ5D , Pain Self-Efficacy Scale . Health care diaries recording patients ' use of health care re sources were also collected over a 12-month period . Results . There were no statistically significant differences in change scores between groups on the primary outcome measure at three months ( CI − 2.24 to 0.49 ) and at 12 months ( CI − 1.68 to 1.39 ) . Only minor improvements in disability scores were observed in the Back to Fitness group at three months and 12 months respectively ( mean change scores ; − 0.89 , − 0.77 ) and in the individual physiotherapy arm ( mean change scores ; − 0.02 , − 0.63 ) . Further analysis showed that patients from the most severely deprived areas were marginally worse at three month follow-up whereas those from more affluent areas tended to improve ( CI 0.43 to 3.15 )",
"Low back pain is the fifth most common reason for all physician visits in the United States ( 1 , 2 ) . Approximately one quarter of U.S. adults reported having low back pain lasting at least 1 whole day in the past 3 months ( 2 ) , and 7.6 % reported at least 1 episode of severe acute low back pain ( see Glossary ) within a 1-year period ( 3 ) . Low back pain is also very costly : Total incremental direct health care costs attributable to low back pain in the U.S. were estimated at $ 26.3 billion in 1998 ( 4 ) . In addition , indirect costs related to days lost from work are substantial , with approximately 2 % of the U.S. work force compensated for back injuries each year ( 5 ) . Many patients have self-limited episodes of acute low back pain and do not seek medical care ( 3 ) . Among those who do seek medical care , pain , disability , and return to work typically improve rapidly in the first month ( 6 ) . However , up to one third of patients report persistent back pain of at least moderate intensity 1 year after an acute episode , and 1 in 5 report substantial limitations in activity ( 7 ) . Approximately 5 % of the people with back pain disability account for 75 % of the costs associated with low back pain ( 8) . Many options are available for evaluation and management of low back pain . However , there has been little consensus , either within or between specialties , on appropriate clinical evaluation ( 9 ) and management ( 10 ) of low back pain . Numerous studies show unexplained , large variations in use of diagnostic tests and treatments ( 11 , 12 ) . Despite wide variations in practice , patients seem to experience broadly similar outcomes , although costs of care can differ substantially among and within specialties ( 13 , 14 ) . The purpose of this guideline is to present the available evidence for evaluation and management of acute and chronic low back pain ( see Glossary ) in primary care setting s. The target audience for this guideline is all clinicians caring for patients with low ( lumbar ) back pain of any duration , either with or without leg pain . The target patient population is adults with acute and chronic low back pain not associated with major trauma . Children or adolescents with low back pain ; pregnant women ; and patients with low back pain from sources outside the back ( nonspinal low back pain ) , fibromyalgia or other myofascial pain syndromes , and thoracic or cervical back pain are not included . These recommendations are based on a systematic evidence review summarized in 2 background papers by Chou and colleagues in this issue ( 15 , 16 ) from an evidence report by the American Pain Society ( 17 ) . The evidence report ( 17 ) discusses the evidence for the evaluation , and the 2 background papers ( 15 , 16 ) summarize the evidence for management . Methods The literature search for this guideline included studies from MEDLINE ( 1966 through November 2006 ) , the Cochrane Data base of Systematic Review s , the Cochrane Central Register of Controlled Trials , and EMBASE . The literature search included all English- language articles reporting on r and omized , controlled trials of nonpregnant adults ( age > 18 years ) with low back pain ( alone or with leg pain ) of any duration that evaluated a target medication and reported at least 1 of the following outcomes : back-specific function , generic health status , pain , work disability , or patient satisfaction . The American College of Physicians ( ACP ) and the American Pain Society ( APS ) convened a multidisciplinary panel of experts to develop the key questions and scope used to guide the evidence report , review its results , and formulate recommendations . The background papers by Chou and colleagues ( 15 , 16 ) provide details about the methods used for the systematic evidence review . This guideline grade s its recommendations by using the ACP 's clinical practice guidelines grading system , adapted from the classification developed by the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) work group ( Appendix Table 1 ) ( 18 ) . The evidence in this guideline was first evaluated by the ACP/APS panel by using a system adopted from the U.S. Preventive Services Task Force for grading strength of evidence , estimating magnitude of benefits , and assigning summary ratings ( Appendix Tables 2 , 3 , and 4 ) ( 19 ) . The evidence was independently review ed by the ACP 's Clinical Efficacy Assessment Subcommittee . The ratings for individual low back pain interventions discussed in this guideline are summarized in Appendix Table 5 for acute low back pain ( 4 weeks ' duration ) . This guideline considered interventions to have proven benefits only when they were supported by at least fair- quality evidence and were associated with at least moderate benefits ( or small benefits but no significant harms , costs , or burdens ) . Figures 1 and 2 present an accompanying algorithm . Appendix Table 1 . The American College of Physicians Clinical Practice Guidelines Grading System Appendix Table 2 . Methods for Grading the Strength of the Overall Evidence for an Intervention Appendix Table 3 . Definitions for Estimating Magnitude of Effects Appendix Table 4 . Recommendations and Summary Ratings Appendix Table 5 . Level of Evidence and Summary Grade s for Noninvasive Interventions in Patients with Acute Low Back Pain Appendix Table 6 . Level of Evidence and Summary Grade s for Noninvasive Interventions in Patients with Chronic or Subacute Low Back Pain Figure 1 . Initial evaluation of low back pain ( LBP Figure 2 . Management of low back pain ( LBP Recommendations : Evaluation of Low Back Pain Recommendation 1 : Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories : nonspecific low back pain , back pain potentially associated with radiculopathy or spinal stenosis , or back pain potentially associated with another specific spinal cause . The history should include assessment of psychosocial risk factors , which predict risk for chronic disabling back pain ( strong recommendation , moderate- quality evidence ) . More than 85 % of patients who present to primary care have low back pain that can not reliably be attributed to a specific disease or spinal abnormality ( nonspecific low back pain [ see Glossary ] ) ( 20 ) . Attempts to identify specific anatomical sources of low back pain in such patients have not been vali date d in rigorous studies , and classification schemes frequently conflict with one another ( 21 ) . Moreover , no evidence suggests that labeling most patients with low back pain by using specific anatomical diagnoses improves outcomes . In a minority of patients presenting for initial evaluation in a primary care setting , low back pain is caused by a specific disorder , such as cancer ( approximately 0.7 % of cases ) , compression fracture ( 4 % ) , or spinal infection ( 0.01 % ) ( 22 ) . Estimates for prevalence of ankylosing spondylitis in primary care patients range from 0.3 % ( 22 ) to 5 % ( 23 ) . Spinal stenosis ( see Glossary ) and symptomatic herniated disc ( see Glossary ) are present in about 3 % and 4 % of patients , respectively . The cauda equina syndrome ( see Glossary ) is most commonly associated with massive midline disc herniation but is rare , with an estimated prevalence of 0.04 % among patients with low back pain ( 24 ) . A practical approach to assessment is to do a focused history and physical examination to determine the likelihood of specific underlying conditions and measure the presence and level of neurologic involvement ( 24 , 25 ) . Such an approach facilitates classification of patients into 1 of 3 broad categories : nonspecific low back pain , back pain potentially associated with radiculopathy ( see Glossary ) or spinal stenosis ( suggested by the presence of sciatica [ see Glossary ] or pseudoclaudication ) , and back pain potentially associated with another specific spinal cause . The latter category includes the small proportion of patients with serious or progressive neurologic deficits or underlying conditions requiring prompt evaluation ( such as tumor , infection , or the cauda equina syndrome ) , as well as patients with other conditions that may respond to specific treatments ( such as ankylosing spondylitis or vertebral compression fracture ) . Diagnostic triage into 1 of these 3 categories helps guide subsequent decision making . Clinicians should inquire about the location of pain , frequency of symptoms , and duration of pain , as well as any history of previous symptoms , treatment , and response to treatment . The possibility of low back pain due to problems outside the back , such as pancreatitis , nephrolithiasis , or aortic aneurysm , or systemic illnesses , such as endocarditis or viral syndromes , should be considered . All patients should be evaluated for the presence of rapidly progressive or severe neurologic deficits , including motor deficits at more than 1 level , fecal incontinence , and bladder dysfunction . The most frequent finding in the cauda equina syndrome is urinary retention ( 90 % sensitivity ) ( 24 ) . In patients without urinary retention , the probability of the cauda equina syndrome is approximately 1 in 10000 . Clinicians should also ask about risk factors for cancer and infection . In a large , prospect i ve study from a primary care setting , a history of cancer ( positive likelihood ratio , 14.7 ) , unexplained weight loss ( positive likelihood ratio , 2.7 ) , failure to improve after 1 month ( positive likelihood ratio , 3.0 ) , and age older than 50 years ( positive likelihood ratio , 2.7 ) were each associated with a higher likelihood for cancer ( 26 ) . The posttest probability of cancer in patients presenting with back pain increases from approximately 0.7 % to 9 % in patients with a history of cancer ( not including nonmelanoma skin cancer ) . In patients with any 1 of the other 3 risk factors , the likelihood of cancer only increases to approximately 1.2 % ( 26 ) . Features predicting the presence of vertebral infection have not been well studied",
"Objectives : To determine , using unsupervised walking programmes , the effects of exercise at a level lower than currently recommended to improve cardiovascular risk factors and functional capacity . Design : 12 week r and omised controlled trial . Setting : Northern Irel and Civil Service ; home-based walking . Participants : 106 healthy , sedentary 40 to 61 year old adults of both sexes . Interventions : Participants were r and omly allocated to a walking programme ( 30 minutes brisk walking three days a week ( n = 44 ) or five days a week ( n = 42 ) ) or a control group ( n = 20 ) . Participants could choose to walk in bouts of at least 10 minutes . They used pedometers to record numbers of steps taken . Intention to treat analysis of changes within groups was done using paired t tests ; extent of change ( baseline to 12 week measurements ) was compared between groups using analysis of variance and Gabriel ’s post hoc test . Main outcome measures : Blood pressure , serum lipids , body mass index , waist : hip ratio , and functional capacity ( using a 10 m shuttle walk test ) . Main results : 89 % ( 93/106 ) completed the study . Systolic blood pressure and waist and hip circumferences fell significantly both in the three day group ( 5 mm Hg , 2.6 cm , and 2.4 cm , respectively ) and in the five day group ( 6 mm Hg , 2.5 cm , and 2.2 cm ) ( p Functional capacity increased in both groups ( 15 % ; 11 % ) . Diastolic blood pressure fell in the five day group ( 3.4 mm Hg , p<0.05 ) . No changes occurred in the control group . Conclusions : This study provides evidence of benefit from exercising at a level below that currently recommended in healthy sedentary adults . Further studies are needed of potential longer term health benefits for a wider community from low levels of exercise",
"We applied the model of the stages and processes of change to exercise adoption and maintenance . This model has shown promise in advancing theory and treatment of the addictions and other negative health behaviors , but there have been few systematic attempts to apply the model to positive health behaviors , such as exercise adoption . Question naires dealing with the stages and processes of exercise change were developed and administered to a sample of 1,172 participants in a worksite health promotion project . The sample was split r and omly into halves for ( a ) initial model development and testing and ( b ) confirmatory measurement model testing . Additional model confirmation was obtained by examining the hierarchical structure of the processes of change and by conducting Stage x Process analyses . Results suggest that the underlying constructs derived from smoking cessation and other addictive behaviors can be generalized to exercise behavior . Underst and ing the stages and processes of exercise behavior change may yield important information for enhancing exercise adoption , adherence , and relapse prevention at both individual and public health levels",
"1 . The intensity of breathlessness in normal subjects during exercise was measured on seven occasions over a 40-week study period to assess the long-term repeatability of Borg scale estimates of breathlessness . 2 . In all subjects there was a significant correlation ( P = 0.0001 ) between breathlessness and minute ventilation . Minute ventilation measured at each work rate did not differ between the seven exercise tests ( P greater than 0.05 ) . 3 . There was no significant difference between the mean Borg scores ( measured with respect to a given level of ventilation ) in 5 of the 7 test weeks ( P greater than 0.05 ) . The slope of the relationship Borg score/minute ventilation did not differ between the seven exercise tests ( P greater than 0.05 ) . 4 . Breathlessness estimation was highly reproducible both after 1 week and after 40 weeks of the study ( both P greater than 0.05 ) . 5 . The duration without testing between consecutive tests did not affect reproducibility : the mean Borg score was as equally reproducible after an interval of 22 weeks without testing as after an interval of 1 week ( P greater than 0.05 ) . 6 . The Borg scale provides a reliable technique for study ing the sensation of breathlessness over extended time periods",
"Study Design . R and omized clinical trial . Objectives . To compare the long-term effectiveness of medical and chiropractic care for low back pain in managed care and to assess the effectiveness of physical therapy and modalities among patients receiving medical or chiropractic care . Summary of Background Data . Evidence comparing the long-term relative effectiveness of common treatment strategies offered to low back pain patients in managed care is lacking . Methods . A total of 681 low back pain patients presenting to a managed-care facility were r and omized to chiropractic with or without physical modalities , or medical care with or without physical therapy , and followed for 18 months . The primary outcome variables are low back pain intensity , disability , and complete remission . The secondary outcome is participants ' perception of improvement in low back symptoms . Results . Of the 681 patients , 610 ( 89.6 % ) were followed through 18 months . Among participants not assigned to receive physical therapy or modalities , the estimated improvements in pain and disability and 18-month risk of complete remission were a little greater in the chiropractic group than in the medical group ( adjusted RR of remission = 1.29 ; 95 % CI = 0.80–2.07 ) . Among participants assigned to medical care , mean changes in pain and disability and risk of remission were larger in patients assigned to receive physical therapy ( adjusted RR = 1.69 ; 95 % CI = 1.08–2.66 ) . Among those assigned to chiropractic care , however , assignment to methods was not associated with improvement or remission ( adjusted RR = 0.98 ; 95 % CI = 0.62–1.55 ) . Compared with medical care only patients , chiropractic and physical therapy patients were much more likely to perceive improvement in their low back symptoms . However , less than 20 % of all patients were pain-free at 18 months . Conclusions . Differences in outcomes between medical and chiropractic care without physical therapy or modalities are not clinical ly meaningful , although chiropractic may result in a greater likelihood of perceived improvement , perhaps reflecting satisfaction or lack of blinding . Physical therapy may be more effective than medical care alone for some patients , while physical modalities appear to have no benefit in chiropractic care",
"STUDY OBJECTIVE To examine the effects of 30 min of self-paced , non-supervised , brisk walking , 5 days per week on the health and fitness of people aged 50 - 65 years . DESIGN R and omized controlled trial . Members of the intervention group ( n = 21 ) were directed to walk briskly for 30 min , 5 days per week , for 12 weeks . Individuals were given the choice to complete the 30 min of walking in one session or in shorter bouts of no less than 10 min . They were asked to record in a diary the time spent walking and the number of steps taken during a single walk using a pedometer . Participants in the control group ( n = 10 ) were asked to maintain their habitual lifestyle and not change their activity or dietary habits . Measurements of body mass index ( BMI ) , waist/hip ratio ( WHR ) , blood pressure , functional capacity , total cholesterol , triglyceride , and lipoprotein subfractions were taken before and after the program . Changes in 10-year risk estimate for coronary heart disease and stroke were calculated using Framingham risk equations . SETTING Three urban general practice s patients : 31 healthy , sedentary 50- to 65-year-old participants recruited following contact by their general practitioner . MAIN RESULTS The mean time spent walking by the intervention group was 27.72 ( + /-9.79 ) min/day : their adherence to the protocol was 90.3 % . Significant decreases in systolic and diastolic blood pressure , reduction in stroke risk , and increased functional capacity were found within the walking group between baseline and 12-week measurements . No changes were found in these parameters within the control group . Significant reductions in 10-year risk of CHD were observed in both groups . No significant changes were found in lipid levels or anthropometric measurements in either group . CONCLUSIONS The study provides evidence for the benefit to fitness and cardiovascular risk of the \" 30-min brisk walking , 5 days a week \" message to people aged 50 - 65 years who participated in an unsupervised home-based walking program . Further study to overcome the problem of poor recruitment and determine the minimum effective dose of exercise to improve cardiovascular risk prediction scores is required"
] | 4116282e-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE We performed a systematic review , meta- analysis and assessed the evidence supporting a causal link between knee joint loading during walking and structural knee osteoarthritis ( OA ) progression . DESIGN Systematic review , meta- analysis and application of Bradford Hill 's considerations on causation . DATA SOURCES We search ed MEDLINE , Scopus , AMED , CINAHL and SportsDiscus for prospect i ve cohort studies and r and omised controlled trials ( RCTs ) from 1950 through October 2013 . STUDY ELIGIBILITY CRITERIA We selected cohort studies and RCTs in which estimates of knee joint loading during walking were used to predict structural knee OA progression assessed by X-ray or MRI . DATA ANALYSES Meta- analysis was performed to estimate the combined OR for structural disease progression with higher baseline loading . The likelihood of a causal link between knee joint loading and OA progression was assessed from cohort studies using the Bradford Hill guidelines to derive a 0 - 4 causation score based on four criteria and examined for confirmation in RCTs . RESULTS Of the 1078 potentially eligible articles , 5 prospect i ve cohort studies were included . The studies included a total of 452 patients relating joint loading to disease progression over 12 - 72 months . There were very serious limitations associated with the method ological quality of the included studies . The combined OR for disease progression was 1.90 ( 95 % CI 0.85 to 4.25 ; I(2)=77 % ) for each one-unit increment in baseline knee loading . The combined causation score was 0 , indicating no causal association between knee loading and knee OA progression . No RCTs were found to confirm or refute the findings from the cohort studies . CONCLUSIONS There is very limited and low- quality evidence to support for a causal link between knee joint loading during walking and structural progression of knee OA . TRIAL REGISTRATION NUMBER CRD42012003253 | [
"Objective Mechanical factors , in particular increased medial knee joint load , are believed to be important in the structural progression of knee osteoarthritis . This study evaluated the relationship of medial knee load during walking to indices of structural disease progression , measured on MRI , in people with medial knee osteoarthritis . Methods A longitudinal cohort design utilising a subset of participants ( n=144 , 72 % ) enrolled in a r and omised controlled trial of lateral wedge insoles was employed . Medial knee load parameters including the peak knee adduction moment ( KAM ) and the KAM impulse were measured at baseline using three-dimensional gait analysis during walking . MRI at baseline and at 12 months was used to assess structural indices . Multiple regression with adjustment for covariates assessed the relationship between medial knee load parameters and the annual change in medial tibial cartilage volume . Binary logistic regression was used for the dichotomous variables of progression of medial tibiofemoral cartilage defects and bone marrow lesions ( BML ) . Results A higher KAM impulse , but not peak KAM , at baseline was independently associated with greater loss of medial tibial cartilage volume over 12 months ( β=29.9 , 95 % CI 6.3 to 53.5 , p=0.01 ) . No significant relationships were seen between medial knee load parameters and the progression of medial tibiofemoral cartilage defects or BML . Conclusion This study suggests knee loading , in particular the KAM impulse , may be a risk factor for loss of medial tibial cartilage volume . As knee load is modifiable , load-modifying treatments may potentially slow disease progression",
"STUDY DESIGN Prospect i ve cohort study . OBJECTIVES To characterize knee cartilage change in individuals with knee osteoarthritis ( KOA ) who have completed a therapeutic exercise program . BACKGROUND While therapeutic exercise is frequently used successfully to improve pain and function in individuals with KOA , no studies have reported the volume of cartilage change or individual factors that may impact volume of cartilage change in those completing an exercise program for KOA . METHODS Thirteen individuals with KOA underwent magnetic resonance imaging to quantify cartilage volume change in the weight-bearing regions of the medial and lateral femoral condyles and the entire surface of the tibial plateaus from baseline to 1-year follow-up . Body structure and function measures were taken for body mass index , knee axis alignment , knee motion , and knee strength . Activity limitations and activity levels were also measured prior to the therapeutic exercise program , using the Western Ontario and McMaster Universities Osteoarthritis Index and the Physical Activity Scale for the Elderly . At 6 months from baseline , follow-up clinical measurements of knee strength and motion were performed . At 1 year from baseline , imaging of the knee cartilage and knee alignment were performed , and participants completed the Western Ontario and McMaster Universities Osteoarthritis Index and Physical Activity Scale for the Elderly . RESULTS The central region of the medial femoral condyle ( cMF ) had a median volume of cartilage loss of 3.8 % . The other 3 knee tibiofemoral articular surfaces had minimal median cartilage volume change . Individuals were dichotomized into progressors ( n = 6 ) and nonprogressors ( n = 7 ) , based on the st and ard error of measurement of cartilage volume change for the cMF . Progressors were younger , had a larger body mass index , had a higher Kellgren-Lawrence grade in the medial compartment of the knee , and had a greater increase in knee varus alignment from baseline to 1-year follow-up . The progressors also had frontal plane hip and knee kinetics during baseline gait analysis that potentially increased medial knee joint loading . CONCLUSION The loss of cMF cartilage volume was highly variable and the median loss of cartilage was within the range previously reported . Seven of the 13 individuals did not have cMF cartilage volume loss greater than the st and ard error of measurement . Change in cartilage volume of the cMF may be influenced to a greater extent by personal factors than by completion of a therapeutic exercise program . Additional research is needed to decipher the interactions among therapeutic exercise and personal characteristics that impact knee cartilage loss",
"Objective This study aim ed to determine whether the effect of laterally wedged insoles on the adduction moment in knee osteoarthritis ( OA ) declined after one month of wear , and whether higher reported use of insoles was associated with a reduced effect on the adduction moment at one month . Methods Twenty people with medial compartment OA underwent gait analysis in their own shoes wearing i ) no insoles and ; ii ) insoles wedged laterally 5 ° in r and om order . Testing occurred at baseline and after one month of use of the insoles . Participants recorded daily use of insoles in a log-book . Outcomes were the first and second peak external knee adduction moment and the adduction angular impulse , compared across conditions and time with repeated measures general linear models . Correlations were obtained between total insole use and change in gait parameters with used insoles at one month , and change scores were compared between high and low users of insoles using general linear models . Results There was a significant main effect for condition , whereby insoles significantly reduced the adduction moment ( all p total insole use and change in gait parameters with used insoles at one month , nor was there a difference in effectiveness of insoles between high and low users of the insoles at this time . Conclusion Effects of laterally wedged insoles on the adduction moment do not appear to decline after one month of continuous use , suggesting that significant wedge degradation does not occur over the short-term",
"In the GRADE approach , r and omized trials start as high- quality evidence and observational studies as low- quality evidence , but both can be rated down if most of the relevant evidence comes from studies that suffer from a high risk of bias . Well-established limitations of r and omized trials include failure to conceal allocation , failure to blind , loss to follow-up , and failure to appropriately consider the intention-to-treat principle . More recently recognized limitations include stopping early for apparent benefit and selective reporting of outcomes according to the results . Key limitations of observational studies include use of inappropriate controls and failure to adequately adjust for prognostic imbalance . Risk of bias may vary across outcomes ( e.g. , loss to follow-up may be far less for all-cause mortality than for quality of life ) , a consideration that many systematic review s ignore . In deciding whether to rate down for risk of bias -- whether for r and omized trials or observational studies -- authors should not take an approach that averages across studies . Rather , for any individual outcome , when there are some studies with a high risk , and some with a low risk of bias , they should consider including only the studies with a lower risk of bias",
"Objective To assess the effect of lateral wedge insoles compared with flat control insoles on improving symptoms and slowing structural disease progression in medial knee osteoarthritis . Design R and omised controlled trial . Setting Community in Melbourne , Australia . Participants 200 people aged 50 or more with clinical and radiographic diagnosis of mild to moderately severe medial knee osteoarthritis . Interventions Full length 5 degree lateral wedged insoles or flat control insoles worn inside the shoes daily for 12 months . Main outcome measures Primary symptomatic outcome was change in overall knee pain ( past week ) measured on an 11 point numerical rating scale . Primary structural outcome was change in volume of medial tibial cartilage from magnetic resonance imaging scans . Secondary clinical outcomes included changes in measures of pain , function , stiffness , and health related quality of life . Secondary structural outcomes included progression of medial cartilage defects and bone marrow lesions . Results Between group differences did not differ significantly for the primary outcomes of change in overall pain ( −0.3 points , 95 % confidence intervals −1.0 to 0.3 ) and change in medial tibial cartilage volume ( −0.4 mm3 , 95 % confidence interval −15.4 to 14.6 ) , and confidence intervals did not include minimal clinical ly important differences . None of the changes in secondary outcomes showed differences between groups . Conclusion Lateral wedge insoles worn for 12 months provided no symptomatic or structural benefits compared with flat control insoles . Trial registration Australian New Zeal and Clinical Trials Registry ACTR12605000503628 and Clinical Trials.gov NCT00415259",
"Background Osteoarthritis of the knee involving predominantly the medial tibiofemoral compartment is common in older people , giving rise to pain and loss of function . Many people experience progressive worsening of the disease over time , particularly those with varus malalignment and increased medial knee joint load . Therefore , interventions that can reduce excessive medial knee loading may be beneficial in reducing the risk of structural progression . Traditional quadriceps strengthening can improve pain and function in people with knee osteoarthritis but does not appear to reduce medial knee load . A neuromuscular exercise program , emphasising optimal alignment of the trunk and lower limb joints relative to one another , as well as quality of movement performance , while dynamically and functionally strengthening the lower limb muscles , may be able to reduce medial knee load . Such a program may also be superior to traditional quadriceps strengthening with respect to improved pain and physical function because of the functional and dynamic nature . This r and omised controlled trial will investigate the effect of a neuromuscular exercise program on medial knee joint loading , pain and function in individuals with medial knee joint osteoarthritis . We hypothesise that the neuromuscular program will reduce medial knee load as well as pain and functional limitations to a greater extent than a traditional quadriceps strengthening program . Methods / Design 100 people with medial knee pain , radiographic medial compartment osteoarthritis and varus malalignment will be recruited and r and omly allocated to one of two 12-week exercise programs : quadriceps strengthening or neuromuscular exercise . Each program will involve 14 supervised exercise sessions with a physiotherapist plus four unsupervised sessions per week at home . The primary outcomes are medial knee load during walking ( the peak external knee adduction moment from 3D gait analysis ) , pain , and self-reported physical function measured at baseline and immediately following the program . Secondary outcomes include the external knee adduction moment angular impulse , electromyographic muscle activation patterns , knee and hip muscle strength , balance , functional ability , and quality -of-life . Discussion The findings will help determine whether neuromuscular exercise is superior to traditional quadriceps strengthening regarding effects on knee load , pain and physical function in people with medial knee osteoarthritis and varus malalignment . Trial Registration Australian New Zeal and Clinical Trials Registry reference :",
"Osteoarthritic knee pain affects patient mobility . Relief of knee pain in osteoarthritis has been reported to increase loading of the knee during gait , but it is unknown whether such pain relief enhances knee loading during more dem and ing activities such as stair-stepping . The gait of 19 patients and stair-stepping of 14 patients with painful medial compartment osteoarthritis of the knee was assessed before and after pain-relieving intraarticular injection of the knee and compared with those of 21 healthy control subjects . There were significant increases in gait velocity , cadence , maximum external knee adduction moment ( indicating increased loading in the medial compartment of the knee ) , and maximum external hip adduction and ankle abduction moments immediately after the injection . With the exception of velocity and ankle abduction moment , these variables were returned to levels that were not statistically different from those of the control subjects . However , no significant differences were found during stair-stepping in the external adduction-abduction moments about the knee , hip , or ankle after injection . Furthermore , the postinjection magnitudes of these variables during stair-stepping were significantly less than those of the controls . Therefore , although the relief of knee pain is sufficient to enhance gait function in osteoarthritis of the knee , it is insufficient to enhance stair-stepping function",
"OBJECTIVE To evaluate the effects of a modified shoe that incorporates both lateral wedging and a variable-stiffness sole on knee joint loading in 3 population s : individuals with symptomatic and radiographic knee osteoarthritis ( OA ) , asymptomatic overweight individuals , and asymptomatic healthy weight individuals . METHODS Ninety participants ( 30 per group ) underwent a 3-dimensional gait analysis across 3 test conditions : modified shoes , st and ard control shoes , and barefoot . For each condition , the first peak knee adduction moment ( KAM ) and knee flexion moment ( KFM ) ( both expressed as Nm/[body weight × height]% ) as well as the KAM impulse ( expressed as Nm.s/[body weight × height]% ) were determined . RESULTS The modified shoes significantly reduced the peak KAM as compared to the control shoes in both the OA ( P = 0.002 ) and the overweight ( P = 0.03 ) groups . In the OA group , there was no significant difference in peak KAM when walking in the modified shoe as compared to walking barefoot . In the overweight and the healthy weight groups , the peak KAM when walking in the modified shoe was significantly higher than that when walking barefoot ( P the KAM impulse was significantly reduced when walking in the modified shoe as compared to the control shoe ( P in the KFM between walking conditions for any group . CONCLUSION The findings illustrate that a shoe incorporating both a lateral wedge and a variable-stiffness sole can significantly reduce medial knee joint load . Further research examining the effects of these shoes on pain , function , and structural changes in the joint is warranted",
"OBJECTIVE To determine in a prospect i ve population -based cohort study relationships between different measures of body mass and the incidence of severe knee and hip osteoarthritis defined as arthroplasty of knee or hip due to osteoarthritis . MATERIAL S AND METHODS Body mass index ( BMI ) , waist circumference , waist-hip ratio ( WHR ) , weight and percentage of body fat ( BF% ) were measured at baseline in 11,026 men and 16,934 women from the general population . The incidence of osteoarthritis over 11 years was monitored by linkage with the Swedish hospital discharge register . RESULTS 471 individuals had knee osteoarthritis and 551 had hip osteoarthritis . After adjustment for age , sex , smoking and physical activity , the relative risks ( RR ) of knee osteoarthritis ( fourth vs first quartile ) were 8.1 ( 95 % CI 5.3 to 12.4 ) for BMI , 6.7 ( 4.5 to 9.9 ) for waist circumference , 6.5 ( 4.6 to 9.43 ) for weight , 3.6 ( 2.6 to 5.0 ) for BF% and 2.2 ( 1.7 to 3.0 ) for WHR . Corresponding RR for hip osteoarthritis were 2.6 ( 2.0 to 3.4 ) for BMI , 3.0 ( 2.3 to 4.0 ) for weight , 2.5 ( 1.9 to 3.3 ) for waist , 1.3 ( 0.99 to 1.6 ) for WHR and 1.5 ( 1.2 to 2.0 ) for BF% . CONCLUSION All measures of overweight were associated with the incidence of knee osteoarthritis , with the strongest relative risk gradient observed for BMI . The incidence of hip osteoarthritis showed smaller but significant differences between normal weight and obesity . Our results support a major link between overweight and biomechanics in increasing the risk of knee and hip osteoarthritis in men and women",
"OBJECTIVE To investigate whether increased knee joint loading due to improved ambulatory function and walking speed following weight loss achieved over 16 weeks accelerates symptomatic and structural disease progression over a subsequent 1 year weight maintenance period in an obese population with knee osteoarthritis ( OA ) . METHODS Data from a prospect i ve study of weight loss in obese patients with knee OA ( the CARtilage in obese knee OsteoarThritis ( CAROT ) study ) were used to determine changes in knee joint compressive loadings ( model estimated ) during walking after a successful 16 week weight loss intervention . The participants were divided into ' Unloaders ' ( participants that reduced joint loads ) and ' Loaders ' ( participants that increased joint loads ) . The primary symptomatic outcome was changes in knee symptoms , measured with the Knee injury and Osteoarthritis Outcome Score ( KOOS ) question naire , during a subsequent 52 weeks weight maintenance period . The primary structural outcome was changes in tibiofemoral cartilage loss assessed semi-quantitatively ( Boston Leeds Knee Osteoarthritis Score ( BLOKS ) from MRI after the 52 weight maintenance period . RESULTS 157 participants ( 82 % of the CAROT cohort ) with medial and /or lateral knee OA were classified as Unloaders ( n = 100 ) or Loaders ( n = 57 ) . The groups showed similar significant changes in symptoms ( group difference : -2.4 KOOS points [ 95 % CI -6.8:1.9 ] ) and cartilage loss ( group difference : -0.06 BLOKS points [ 95 % CI -0.22:0.11 ) after 1 year , with no statistically significant differences between Loaders and Unloaders . CONCLUSION For obese patients undergoing a significant weight loss , increased knee joint loading for 1 year was not associated with accelerated symptomatic and structural disease progression compared to a similar weight loss group that had reduced ambulatory compressive knee joint loads . CLINICAL TRIALSGOV NCT00655941"
] | 4116286a-06ff-11f0-808a-c43d1ab1c353 |
HighlightsMultisensory temporal dysfunction represented by an extended temporal binding window is a common feature of ASD and SSD.Unisensory temporal acuity is impaired in schizophrenia but may be spared in ASD.Multisensory dysfunction is associated with incoherent perception and communicative deficit that characterize SSD and ASD . & NA ; Multisensory temporal integration could be compromised in both autism spectrum disorders ( ASD ) and schizophrenia spectrum disorders ( SSD ) and may play an important role in perceptual and cognitive impairment in these two disorders . This review aim ed to quantitatively compare the sensory temporal acuity between healthy controls and the two clinical groups ( ASD and SSD ) . Impairment of sensory temporal integration was robust and comparable in both patients with SSD ( Hedges ' g = 0.91 , 95%CI[0.62–1.19 ] ; Z = 6.21 , p and ASD ( Hedges ' g = 0.85 , ( 95%CI[0.54–1.15 ] ; Z = 5.39 , p and unstable effects for unisensory temporal binding in the ASD group , but a more consistent and severe impairment in multisensory temporal integration represented by an enlarged temporal binding window in both clinical groups . Such multisensory dysfunction is associated with symptoms like hallucinations and impaired social communications . Future studies focusing on improving multisensory temporal functions may have important implication s for the amelioration of schizophrenia and autistic symptoms | [
"Recent studies have demonstrated that dyslexia is associated with deficits in the temporal encoding of sensory information . While most previous studies have focused on information processing within a single sensory modality , it is clear that the deficits seen in dyslexia span multiple sensory systems . Surprisingly , although the development of linguistic proficiency involves the rapid and accurate integration of auditory and visual cues , the capacity of dyslexic individuals to integrate information between the different senses has not been systematic ally examined . To test this , we studied the effects of task-irrelevant auditory information on the performance of a visual temporal-order-judgment ( TOJ ) task . Dyslexic subjects ’ performance differed significantly from that of control subjects , specifically in that they integrated the auditory and visual information over longer temporal intervals . Such a result suggests an extended temporal “ window ” for binding visual and auditory cues in dyslexic individuals . The potential deleterious effects of this finding for rapid multisensory processes such as reading are discussed",
"OBJECTIVE To highlight emerging evidence for clinical and biological links between autism/pervasive developmental disorder ( PDD ) and schizophrenia , with particular attention to childhood-onset schizophrenia ( COS ) . METHOD Clinical , demographic , and brain developmental data from the National Institute of Mental Health ( and other ) COS studies and selected family , imaging , and genetic data from studies of autism , PDD , and schizophrenia were review ed . RESULTS In the two large studies that have examined this systematic ally , COS is preceded by and comorbid with PDD in 30 % to 50 % of cases . Epidemiological and family studies find association between the disorders . Both disorders have evidence of accelerated trajectories of anatomic brain development at ages near disorder onset . A growing number of risk genes and /or rare small chromosomal variants ( microdeletions or duplications ) are shared by schizophrenia and autism . CONCLUSIONS Biological risk does not closely follow DSM phenotypes , and core neurobiological processes are likely common for subsets of these two heterogeneous clinical groups . Long-term prospect i ve follow-up of autistic population s and greater diagnostic distinction between schizophrenia spectrum and autism spectrum disorders in adult relatives are needed",
"BACKGROUND This project examined the intermodal perception of temporal synchrony in 16 young children ( ages 4 to 6 years ) with autism compared to a group of children without impairments matched on adaptive age , and a group of children with other developmental disabilities matched on chronological and adaptive age . METHOD A preferential looking paradigm was used , where participants viewed non-linguistic , simple linguistic or complex linguistic events on two screens displaying identical video tracks , but one offset from the other by 3 seconds , and with the single audio track matched to only one of the displays . RESULTS As predicted , both comparison groups demonstrated significant non-r and om preferential looking to violations of temporal synchrony with linguistic and non-linguistic stimuli . However , the group with autism showed an impaired , chance level of responding , except when presented with non-linguistic stimuli . CONCLUSIONS Several explanations are offered for this apparently autism-specific , language -specific pattern of responding to temporal synchrony , and potential developmental sequelae are discussed",
"BACKGROUND Recent research has indicated that autism is not a discrete disorder and that family members of autistic prob and s have an increased likelihood of exhibiting autistic symptoms with a wide range of severity , often below the threshold for a diagnosis of an autism spectrum disorder . OBJECTIVE To examine the distribution and genetic structure of autistic traits in the general population using a newly established quantitative measure of autistic traits , the Social Responsiveness Scale ( formerly known as the Social Reciprocity Scale ) . METHODS The sample consisted of 788 pairs of twins aged 7 to 15 years , r and omly selected from the pool of participants in a large epidemiologic study ( the Missouri Twin Study ) . One parent of each pair of twins completed the Social Responsiveness Scale on each child . The data were subjected to structural equation modeling . RESULTS Autistic traits as measured by the Social Responsiveness Scale were continuously distributed and moderately to highly heritable . Levels of severity of autistic traits at or above the previously published mean for patients with pervasive developmental disorder not otherwise specified were found in 1.4 % of boys and 0.3 % of girls . Structural equation modeling revealed no evidence for the existence of sex-specific genetic influences , and suggested specific mechanisms by which females may be relatively protected from vulnerability to autistic traits . CONCLUSIONS These data indicate that the social deficits characteristic of autism spectrum disorders are common . Given the continuous distribution of these traits , it may be arbitrary where cutoffs are made between research design ations of being \" affected \" vs \" unaffected \" with a pervasive developmental disorder . The genes influencing autistic traits appear to be the same for boys and girls . Lower prevalence ( and severity ) of autistic traits in girls may be the result of increased sensitivity to early environmental influences that operate to promote social competency"
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The deficiency of vitamin D is prevalent all over the world . Studies have shown that vitamin D may play an important role in the development of obesity . The current study was conducted to quantitatively evaluate the association between serum 25-(OH ) vitamin D levels and the risk of obesity in both diabetic and non-diabetic subjects . A systematic review and meta- analysis of observational studies was carried out for that purpose . We search ed the Medline , PubMed , and Embase data bases throughout all of March 2018 . A total of fifty five observational studies for both diabetic and non-diabetic subjects were finally included in the meta- analysis . The data were analyzed by comprehensive meta- analysis software version 3 and the r and om effects model was used to analyze the data . The meta- analysis showed an overall inverse relationship between serum vitamin D status and body mass index ( BMI ) in studies of both diabetic ( r = -0.173 , 95 % = -0.241 to -0.103 , p = 0.000 ) and non-diabetic ( r = -0.152 , 95 % = -0.187 to -0.116 , p = 0.000 ) subjects . The evidence of publication bias was not found in this meta- analysis . In conclusion , the deficiency of vitamin D is associated with an increased level of BMI in the studies of both diabetic and non-diabetic subjects . Reliable evidence from well- design ed future r and omized controlled trials is required to confirm the findings from observational studies and to find out the potential regulatory effects of vitamin D supplementation to lower BMI | [
"Vitamin D deficiency is widely prevalent and has been associated with many diseases . It has been suggested that vitamin D has effects on the immune system and inhibits inflammation . The aim of our study was to investigate whether vitamin D has an inhibitory effect on systemic inflammation by assessing the association between serum levels of vitamin D and C-reactive protein . We studied the association between serum 25-hydroxyvitamin D and C-reactive protein through linear regression in 9,649 participants of the Rotterdam Study , an observational , prospect i ve population -based cohort study . We used genetic variants related to vitamin D and CRP to compute a genetic risk score and perform bi-directional Mendelian r and omization analysis . In linear regression adjusted for age , sex , cohort and other confounders , natural log-transformed CRP decreased with 0.06 ( 95 % CI : -0.08 , -0.03 ) unit per st and ard deviation increase in 25-hydroxyvitamin D. Bi-directional Mendelian r and omization analyses showed no association between the vitamin D genetic risk score and lnCRP ( Beta per SD = -0.018 ; p = 0.082 ) or the CRP genetic risk score and 25-hydroxyvitamin D ( Beta per SD = 0.001 ; p = 0.998 ) . In conclusion , higher levels of Vitamin D are associated with lower levels of C-reactive protein . In this study we did not find evidence for this to be the result of a causal relationship",
"OBJECTIVE —Accumulating epidemiological evidence suggests that hypovitaminosis D may be associated with type 2 diabetes and related metabolic risks . However , prospect i ve data using the biomarker serum 25-hydroxyvitamin D [ 25(OH)D ] are limited and therefore examined in the present study . RESEARCH DESIGN AND METHODS —A total of 524 r and omly selected nondiabetic men and women , aged 40–69 years at baseline , with measurements for serum 25(OH)D and IGF-1 in the population -based Ely Study , had glycemic status ( oral glucose tolerance ) , lipids , insulin , anthropometry , and blood pressure measured and metabolic syndrome risk ( metabolic syndrome z score ) derived at baseline and at 10 years of follow-up . RESULTS —Age-adjusted baseline mean serum 25(OH)D was greater in men ( 64.5 nmol/l [ 95 % CI 61.2–67.9 ] ) than women ( 57.2 nmol/l [ 54.4,60.0 ] ) and varied with season ( highest late summer ) . Baseline 25(OH)D was associated inversely with 10-year risk of hyperglycemia ( fasting glucose : β = −0.0023 , P = 0.019 ; 2-h glucose : β = −0.0097 , P = 0.006 ) , insulin resistance ( fasting insulin β = −0.1467 , P = 0.010 ; homeostasis model assessment of insulin resistance [ HOMA-IR ] : β = −0.0059 , P = 0.005 ) , and metabolic syndrome z score ( β = −0.0016 , P = 0.048 ) after adjustment for age , sex , smoking , BMI , season , and baseline value of each metabolic outcome variable . Associations with 2-h glucose , insulin , and HOMA-IR remained significant after further adjustment for IGF-1 , parathyroid hormone , calcium , physical activity , and social class . CONCLUSIONS —This prospect i ve study reports inverse associations between baseline serum 25(OH)D and future glycemia and insulin resistance . These associations are potentially important in underst and ing the etiology of abnormal glucose metabolism and warrant investigation in larger , specifically design ed prospect i ve studies and r and omized controlled trials of supplementation",
"Background & objectives : Patients with diabetes and vitamin-D insufficiency have increased insulin resistance . Similar observations among individuals with prediabetes are not well documented . The aim of this study was to find the occurrence of vitamin-D insufficiency/deficiency among individuals with prediabetes and to evaluate the relationship between vitamin-D status and insulin resistance . Methods : One hundred fifty seven individuals with prediabetes who fulfilled all the inclusion and exclusion criteria underwent clinical examination , anthropometric measurements ( waist circumference , waist-hip ratio , waist-height ratio ) and blood sampling after overnight fast for estimation of fasting blood glucose , fasting insulin , 25(OH)vitamin-D , intact parathyroid hormone ( iPTH ) and lipid profile . One hour post 75 g glucose ( 1hPG ) blood glucose during oral glucose tolerance test was measured . Results : Vitamin-D deficiency/insufficiency was found in 115 ( 73.25 % ) individuals with prediabetes . Severe vitamin-D deficiency ( vitamin-D levels ( highest insulin resistance ( HOMA2-IR : 2.04 ± 0.67 ) . Serum 25(OH)D had a statistically significant inverse correlation with insulin resistance ( HOMA2-IR ; r=-0.33 ; P=0.008 ) , and positive correlation with insulin sensitivity ( QUICKI ; r=0.39 ; P=0.002 ) , after adjusting for BMI and HbA1c . There was no correlation between vitamin-D status and estimated beta cell mass ( HOMA-β ) . The mean waist-height ratio among individuals with prediabetes was 0.57 ( normal155 mg/dl had significantly higher BMI and worse insulin resistance , and 1hPG correlated well with 2 hour post glucose blood glucose ( r=0.57 ; P Vitamin-D deficiency/insufficiency may have some role in the development/worsening of insulin resistance in individuals with prediabetes in our country who have a high cardiovascular risk . Prospect i ve studies on a large group of individuals need to be done to confirm the findings",
"Background and Aims . Despite growing interest in the protective role that vitamin D may have in health outcomes , little research has examined the mechanisms underlying this role . This study aim ed to test two hypotheses : ( 1 ) serum 25-hydroxyvitamin D [ 25(OH)D ] is inversely associated with type 2 diabetes mellitus ( T2DM ) and elevated hemoglobin A1c ; ( 2 ) these associations are mediated by serum C-reactive protein ( CRP ) . Methods . Participants aged 20 and older in 2001–2006 National Health and Nutrition Examination Surveys ( n = 8,655 ) with measures of serum 25(OH)D , CRP , hemoglobin A1c , and other important covariates were included in the present study . Logistic regression and path analysis methods were applied to test the study hypotheses . Results . Decreased serum 25(OH)D concentration was significantly associated with increased odds of T2DM . In males , an estimated 14.9 % of the association between 25(OH)D and hemoglobin A1c was mediated by serum CRP . However , this mediation effect was not observed in females . Conclusion . Using a nationally representative sample , the present study extends previous research and provides new evidence that the effect of decreased serum vitamin D concentration on T2DM may proceed through increased systemic inflammation in males . Longitudinal studies and r and omized control trials are needed to confirm the present findings",
"OBJECTIVE To study daily intake of calcium , phosphorus and vitamin D , to determine the biochemical findings of rickets and the effect of sunlight exposure and vitamin D supplementation in school girls with hypovitaminosis D. METHODS A cross-sectional study was conducted on school girls aged 11 - 15 years selected r and omly from various areas of Tehran , Iran . Dietary information and amount of sunlight exposure were estimated by a 7 day recalling method using self-reported question naire . Hypovitaminosis D defined as low serum 25-hydroxyvitamin D concentration with two or more others abnormal biochemical findings . Girls with hypovitaminoses D were r and omly divided into two groups . The faces and h and s of girls in group 1 were exposed to sunlight for one hour per day for twenty days , while those in group 2 were administered vitamin D capsules , 50,000 IU per day for the same period . RESULTS four-hundred fourteen girls evaluated , mean daily calcium intake , sunlight exposure and vitamin D acquirement were 360 mg , 10 minutes and 119 IU , respectively . Mean serum 25-hydroxyvitamin D concentration was 30 ng/ml among all girls whereas in 15 ( 3.63 % ) of 414 girls was 7.8 ng/ml . Abnormal biochemical findings in these girls included hypocalcemia ( n=4 ) , hypophosphatemia ( n=5 ) , raised serum alkaline phosphatase ( n=13 ) , and parathyroid hormone ( n=15 ) . After intervention , mean serum 25-hydroxyvitamin D concentration in sunlight exposure ( n=8 ) and vitamin D ( n=7 ) supplementation increased to 14.4+/-4 ng/ml and 23+/-4 ng/ml respectively . There was a significant difference between the two groups ( p Vitamin D deficiency developed in rapid growth period of girls without clear clinical rickets in sunny temperate climate city in Iran which vitamin D supplementation improved biochemical findings better than sunlight exposure",
"OBJECTIVE To examine cross-sectional relationships between plasma vitamin D and cardiometabolic risk factors in young adults . DESIGN Data were collected from interviews , physical examinations and biomarker measurements . Total plasma 25-hydroxyvitamin D ( 25(OH)D ) was measured using LC-t and em MS . Associations between 25(OH)D and cardiometabolic risk factors were modelled using weighted linear regression with robust estimates of st and ard errors . SETTING Individuals born in Jerusalem during 1974 - 1976 . SUBJECTS Participants of the Jerusalem Perinatal Study ( n 1204 ) interviewed and examined at age 32 years . Participants were over sample d for low and high birth weight and for maternal pre-pregnancy obesity . RESULTS Mean total 25(OH)D concentration among participants was 21·7 ( sd 8·9 ) ng/ml . Among males , 25(OH)D was associated with homeostatic model assessment of insulin resistance ( natural log-transformed , β=-0·011 , P=0·004 ) after adjustment for BMI . However , these associations were not present among females ( P for sex interaction=0·005 ) . CONCLUSIONS We found evidence for inverse associations of 25(OH)D with markers of insulin resistance among males , but not females , in a healthy , young adult Caucasian population . Prospect i ve studies and studies conducted on other population s investigating sex-specific effects of vitamin D on cardiometabolic risk factors are warranted",
"PURPOSE We examined the cross-sectional associations among cardiorespiratory fitness ( CRF ) , different measures of adiposity , and serum vitamin D levels in women . METHODS Between 2007 and 2010 , 1320 women completed a health examination . Measures included body mass index ( BMI ) , waist circumference ( WC ) , waist/hip ratio , percent body fat , CRF based on a maximal treadmill exercise test , and measurement of serum vitamin D. Participants were classified by CRF as unfit ( lowest 20 % ) and fit ( remaining 80 % ) based on age , as well as by clinical cutoff points for adiposity measures , and by categories of serum vitamin D. We examined trends of CRF and adiposity exposures across serum vitamin D categories . We calculated odds ratios ( OR ) of serum vitamin D insufficiency or deficiency across levels of adiposity exposures before and after adjustment for CRF . RESULTS We observed a significant positive trend for CRF across incremental serum vitamin D categories ( p for serum vitamin D insufficiency or deficiency were significantly higher for overweight women within each adiposity exposure ( p serum vitamin D was significantly lower in unfit than in fit women within each stratum of WC and waist/hip ratio and within the normal weight BMI stratum . CONCLUSIONS Serum vitamin D levels are positively associated with CRF and negatively associated with different measures of adiposity in women . Higher CRF attenuates the relationship between adiposity level and serum vitamin D. Future prospect i ve studies are warranted",
"Summary The various factors that may contribute to vitamin D deficiency or insufficiency were examined among healthy Saudi pre- and postmenopausal women . Vitamin D deficiency was highly prevalent among studied Saudi women with obesity , poor sunlight exposure , poor dietary vitamin D supplementation and age as the main risk factors . Introduction The various factors that may contribute to vitamin D deficiency or insufficiency in relation to bone health among Saudi women are not known . The main objectives of the present study were to determine the factors influencing vitamin D status in relation to serum 25-hydroxyvitamin D ( 25(OH)D ) , intact parathyroid hormone ( PTH ) , bone turnover markers ( BTMs ) , bone mineral density ( BMD ) , and vitamin D receptor genotype ( VDR ) in healthy Saudi pre- and postmenopausal women . Methods A total number of 1,172 healthy Saudi women living in the Jeddah area were r and omly selected and studied . Anthropometric parameters , socioeconomic status , sun exposure index together with serum levels of 25(OH)D , calcitriol , intact PTH , Ca , PO4 , Mg , creatinine , albumin , and biochemical BTMs were measured . BMD was measured by a dual energy X-ray absorptiometry and VDR genotypes were also determined . Results About 80.0 % of Saudi women studied exhibited vitamin D deficiency ( serum 25(OH)D 75 nmol/L ) . Secondary hyperparathyroidism was evident in 18.5 % and 24.6 % in pre- and postmenopausal women with 25(OH)D Serum 25(OH)D was lower ( P intact PTH higher ( P ratio ( WHR ) . Multiple linear regression analysis showed that BMI , sun exposure index , poor dietary vitamin D supplementation , WHR , and age were independent positive predictors of serum 25(OH)D values . Conclusions Vitamin D deficiency is highly prevalent among healthy Saudi pre- and postmenopausal women and largely attributed to obesity , poor exposure to sunlight , poor dietary vitamin D supplementation , and age",
"BACKGROUND 25-Hydroxyvitamin D [ 25(OH)D ] levels are lower in obese individuals . Determining whether low vitamin D status can predispose weight gain requires a longitudinal study . METHODS From a community-based multicenter U.S. prospect i ve cohort of 9704 ( Study of Osteoporotic Fractures [ SOF ] ) , 4659 women aged ≥65 with baseline 25(OH)D measurement were followed for 4.5 years . They were weighed at baseline and follow-up visits , and a subset ( n=1054 ) had 25(OH)D levels remeasured at follow-up . RESULTS Women with 25(OH)D levels ≥30 ng/mL had lower baseline weight ( 141.6 pounds ) compared to women with 25(OH)D levels with weight change over 4.5 years , although there was a significant interaction between 25(OH)D status and weight change category ( loss , gain , stable ) ( p % weight , those with baseline 25(OH)D levels ≥30 ng/mL gained 16.4 pounds ( 12.2 % of baseline weight ) over 4.5 years compared to 18.5 pounds ( 13.9 % of baseline weight ) in women with levels % weight or remained stable ( 25(OH)D status at baseline and weight change . Among women who gained weight and had 25(OH)D measured at both visits , having sustained or developing 25(OH)D levels ≥30 ng/mL was associated with less weight gain between visits ( 14.81 vs. 16.34 pounds , p=0.04 ) . CONCLUSIONS Higher 25(OH)D levels are associated with lower weight gains , suggesting low vitamin D status may predispose to fat accumulation",
"Abstract Objective Patients with chronic kidney disease have a very high prevalence of deficiency of 25-hydroxyvitamin D [ 25(OH)D ] . We evaluate the association between 25(OH)D and diabetic nephropathy ( DN ) in a Chinese sample with type 2 diabetes mellitus . Method The subjects were patients with diabetes mellitus who were hospitalized at our hospital during the period from June 2012 to July 2014 . Serum levels of 25(OH)D were tested at admission . DN was defined as a urinary albumin-to-creatinine ratio ≥30 mg/g in a r and om spot urine sample . Multivariate analyses were performed using logistic regression models . Results We found that serum 25(OH)D levels were significantly lower in diabetes with DN as compared to without DN [ 8.5 ( IQR 6.8–11.3 ) vs. 13.9 ( IQR 11.2–18.2 ) ng/ml , P of serum 25(OH)D levels as an indicator for diagnosis of DN was projected to be 10.5 ng/ml , which yielded a sensitivity of 82.6 % and a specificity of 72.7 % , with the area under the curve at 0.807 [ 95 % confidence interval ( CI ) 0.764–0.849 ] . Multivariate logistic regression analysis adjusted for common risk factors showed that with serum 25(OH)D level ≤10.5 ng/ml was an independent indicator of DN [ odds ratio ( OR ) = 6.559 ; 95 % CI 2.864–11.368 ] . Conclusions Our findings suggested that diabetes with DN had lower serum 25(OH)D levels and that determination of 25(OH)D statuses might be used to identify patients at increased risk of developing nephropathy complications",
"BACKGROUND Recent studies suggest an association between 25-hydroxyvitamin D [ 25(OH)D ] and type 2 diabetes ( T2D ) risk . However , prospect i ve studies investigating the relation between vitamin D inadequacy and incidence of T2D incorporating obesity and dynamic measures of insulin resistance ( IR ) and pancreatic β cell function are limited . OBJECTIVE We tested the hypothesis that baseline 25(OH)D is associated with the incidence of T2D in high-risk subjects for up to 5 y of follow-up , independently of obesity , baseline IR , and β cell function . DESIGN We recruited 1080 nondiabetic Korean subjects [ mean ± SD age : 49.5 ± 11.4 y ] based on the presence of one or more risk factors for T2D , including obesity , hypertension , dyslipidemia , and /or family history of T2D . We measured anthropometric and biochemical indicators , HOMA2-IR , and the insulinogenic index ( IGI ; calculated as change in insulin at 30 min/change in glucose at 30 min ) from a 75-g oral-glucose-tolerance test . RESULTS Of the participants , 10.5 % had a serum 25(OH)D deficiency ( the incidence of T2D at 32.3 ± 15.6 mo ( ±SD ) declined accordingly : 15.9 % , 10.2 % , and 5.4 % , respectively ( P an increased risk of T2D independently of BMI , HOMA2-IR , and IGI ; the HRs were 2.06 ( 95 % CI : 1.22 , 3.49 ) for 25(OH)D 10 - 19.9 ng/mL compared with ≥20 ng/mL and 3.23 ( 95 % CI : 1.66 , 6.30 ) for 25(OH)D < 10 ng/mL compared with ≥20 ng/mL. CONCLUSION The current prospect i ve study suggests that vitamin D metabolism may play a role in T2D pathogenesis independently of known risk factors . This trial was registered at clinical trials.gov as NCT01508481",
"Abstract Objectives : Visceral fat is more harmful than subcutaneous fat . Women with high amounts of visceral fat have an increased risk of metabolic syndrome ( MetS ) , insulin resistance and low level of serum vitamin D. Methods : This was a prospect i ve , r and omized and controlled study . Postmenopausal women ( n = 101 ) aged 45–70 years were included . The assessed parameters were : body mass index ( BMI ) , waist circumference ( WC ) , 25-hydroxyvitamin D ( 25-OHD ) status , serum insulin and HOMA-IR , bone mineral density , total fat mass , fat mass index ( FMI ) measured by DXA , and muscle strength . Results : Significantly lower values of 25-OHD ( 35.26 ± 1.61 nmol/l ) were found in women with MetS compared to those without MetS ( 47.52 ± 3.47nmol/l ) ( t = 3.699 ; p between 25-OHD levels and : WC ( rhoWC = −0.94 ; p 0.004 ) , BMI ( rho BMI = −0.80 ; p and impaired fasting glucose ( IFG ) ( rhoIFG = −0.23 ; p The percentage of body fat was statistically significantly higher in the group with insufficient 25-OHD ( 39.6 % ) and in the group with a deficit of 25-OHD ( 48.2 % ) , compared with the maximum permitted percentage body fat of 35 % for a female ( t = −22.63 ; p The average h and grip strength of these moderately obese participants was 27.4 ± 4.7 kg . It was significantly lower than the normative grip strength for referent range groups ( t = −21.65 ; p low 25-OHD level in postmenopausal women is associated with high body fat , metabolic syndrome , low muscular strength and osteopenia",
"BACKGROUND Low concentrations of circulating vitamin D are common with obesity and may represent a potential mechanism explaining the elevated risk of certain cancers and cardiovascular outcomes observed in individuals who are overweight or obese . OBJECTIVE The objective of this study was to investigate the effects of 12 mo of weight loss through caloric restriction , exercise intervention , or both on serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations . DESIGN Overweight and obese postmenopausal women ( n = 439 ) were r and omly assigned to 1 of 4 groups : 1 ) diet modification ( n = 118 ) , 2 ) exercise ( n = 117 ) , 3 ) diet + exercise ( n = 117 ) , or 4 ) control ( n = 87 ) . The diet intervention was a group-based reduced-calorie program with a 10 % weight-loss goal . The exercise intervention consisted of 45 min of moderate-to-vigorous intensity aerobic activity daily for 5 d/wk . Serum 25(OH)D concentrations were measured by using a competitive chemiluminescent immunoassay at baseline and 12 mo . RESULTS No significant change in serum 25(OH)D was found between the intervention and control groups . Women who lost baseline weight had mean increases in 25(OH)D of 2.1 , 2.7 , 3.3 , and 7.7 ng/mL , respectively ( P for trend = 0.002 ) . Baseline vitamin D status did not modify the effect of the interventions on weight loss or body-composition changes at the 12-mo follow-up . CONCLUSION A greater degree of weight loss , achieved through either a reduced-calorie diet or increased exercise , is associated with increased circulating 25(OH)D concentrations . This trial is registered at clinical trials.gov as NCT00470119",
"OBJECTIVE The serum 25-hydroxyvitamin D ( 25(OH)D ) level is not only dependent on vitamin D intake and production in the skin but also dependent on genetic factors . Thus , in large genome-wide association studies , it has been shown that single nucleotide polymorphisms ( SNPs ) in the vitamin D binding protein ( DBP ) , as well as in enzymes related to activation or degradation of vitamin D and its metabolites , are as important for the serum 25(OH)D level as the effect of season . How these SNPs affect the serum 25(OH)D response to vitamin D supplementation is uncertain . DESIGN AND METHODS Data were pooled from three r and omized controlled trials where 40 , 000 IU vitamin D/week was given for 6 months . Serum 25(OH)D was measured before and at the end of the intervention , and the subjects were genotyped for SNPs related to the serum 25(OH)D level . RESULTS Baseline 25(OH)D levels were significantly related to SNPs in the DBP and CYP2R1 genes . Those with SNPs associated with the lowest baseline 25(OH)D levels also had the smallest increase ( delta ) after supplementation . Those with the lowest baseline serum 25(OH)D ( without regard to genotypes ) had the highest increase ( delta ) after supplementation . Subjects with high BMI had lowest baseline 25(OH)D levels and also the smallest increase ( delta ) after supplementation . CONCLUSIONS The serum 25(OH)D response to supplementation depends on genes , baseline level , and BMI . However , whether this is clinical ly important or not depends on the therapeutic window of vitamin D , an issue that is still not settled"
] | 411628ec-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVES To perform a systematic review of test method ologies on conventional restorative glass-ionomer cement ( GIC ) material s for mechanical and optical properties to compare the results between different GICs . MATERIAL AND METHODS Screening of titles and abstract s , data extraction , and quality assessment s of full-texts were conducted in search for in vitro studies on conventional GICs that follow the relevant specifications of ISO st and ards regarding the following mechanical and optical properties : compressive strength , flexural strength , color , opacity and radiopacity . SOURCES The Latin American and Caribbean Health Sciences ( LILACS ) , Brazilian Bibliography of Dentistry ( BBO ) data bases from Latin-American and Caribbean System on Health Sciences Information ( BIREME ) and PubMed / Medline ( US National Library of Medicine - National Institutes of Health ) data bases were search ed regardless of language . Altogether , 1146 in vitro studies were selected . Two review ers independently selected and assessed the articles according to pre-established inclusion /exclusion criteria . Among all the properties investigated , only one study was classified as being of fair quality that tested compressive strength and was included . It was observed that many authors had not strictly followed ISO recommendations and that , for some properties ( diametral tensile strength and microhardness ) , there are no guidelines provided . CONCLUSIONS It was not possible to compare the results for the mechanical and optical properties of conventional restorative GICs due to the lack of st and ardization of studies | [
"This study investigated the effects of an at-home bleaching gel containing 15 % carbamide peroxide on the susceptibility of tooth-colored restorative material s to different staining solutions . The tooth-colored restoratives used in this study were a nano resin composite ( Filtek Z350 ) , a packable resin composite ( Filtek P60 ) , a polyacid-modified composite ( Dyract AP ) and a glass-ionomer cement ( Ketac Molar Easymix ) . Each material was equally divided into two groups ( n = 34 ) : the bleaching group and the control group . This study included two treatment segments . In the first part ( days 1 - 14 ) , the specimens of the bleaching group were bleached with 15 % carbamide peroxide gels for eight hours daily , while the specimens in the control group were stored in deionized water . Subsequently , four specimens from each group were r and omly selected for observation under an environmental scanning electron microscope . In the second part ( days 15 - 42 ) , the sample s were not bleached . Instead , they were stored in five different kinds of solutions . Color measurements for each sample were taken at six different time periods using a spectrophotometer . The data was then analyzed using SPSS statistical software . After two-weeks of bleaching , all the specimens showed statistically significant color changes compared with the control specimens . Furthermore , the bleaching agents seriously affected the surface morphology of Dyract AP and Ketac Molar Easymix . Following exposure to the staining solutions , it was found that the bleached restorative material s exhibited greater staining susceptibility than the control material s. Filtek Z350 and P60 exhibited the best color stability , while Dyract AP exhibited the least color stability",
"Fluoride varnish applications were applied to two hybrid resin composite material s , Z-100 ( 3 M Dental Products , St Paul , MN , USA ) and Esthet-X ( Dentsply Caulk , Milford , DE , USA ) , shades A1 and A2 and a glass ionomer , GC Fuji IX GP Fast ( GC Corporation , Tokyo , Japan ) , shade A2 , to evaluate color stability . Specimens ( 12.6-mm dia x 2.3 mm ) were prepared using a polyethylene frame , light-cured and polished through a 1-microm alumina finish . After the initial baseline color measurements , the discs were suspended in Fusayama artificial saliva ( FAS ) solution at 37 degrees C for 48 hours . Post immersion , the specimens were divided into five groups ( n=15 each ) . The following fluoride varnishes were applied to four groups of test specimens : Duraphat ( Colgate Oral Pharmaceutical , Inc , Canton MA , USA ) , Cavity Shield ( OMNII Oral Pharmaceuticals , West Palm Beach , FL , USA ) , Duraflor ( Pharmascience Inc , Montreal , Canada ) and Fluor Protector ( Vivadent , Ivoclar North America , Amherst , NY , USA ) . The varnish was allowed to dry for five minutes before immersion . The control group was not coated with varnish , although the specimens were immersed in FAS . All specimens were incubated in newly prepared FAS at 37 degrees C for 24 hours , cleaned with an electric toothbrush and the process repeated using newly prepared FAS . CIE L*a*b * color measurements were recorded five times : at baseline , after 48 hours FAS immersion , after cleaning the first and second fluoride varnish applications and after the final brushing using a commercial toothpaste ( Crest ) . A Minolta CR-300 tristimulus colorimeter with an 8-mm aperture ( Ramsey , NJ , USA ) was used to record color measurements with the daylight ( D65 ) setting . Calculations were performed for using CIE parameters deltaE * , deltaL * , delta a * , delta b*. Analysis of variance ( ANOVA ) and post-hoc test ( Fisher 's PLSD ) were used for statistical analysis . After immersion in saliva , the tested glass ionomer ( Fuji IX ) produced the most significant color changes ( deltaE*=1.19 and deltaL*=-1.03 ) , indicating the effect of the color change was due to absorption . After fluoride varnish applications , Duraphat varnish produced significant changes in all tested material s and shades , result ing in color changes with deltaE greater than ( > ) 1 but less than ( color changes are considered visually perceptible , yet have been reported in dental literature as clinical ly acceptable . Fluoride varnishes can be used without adversely affecting the color of restorative material",
"OBJECTIVES Three strength tests ( compressive , three point flexure and biaxial ) were performed on three glass ionomer ( GI ) restoratives to assess the most appropriate methodology in terms of validity and reliability . The influence of mixing induced variability on the data sets generated were eliminated by using encapsulated GIs . METHODS Specimen groups of 40 ( eight batches of n=5 ) cylinders ( 6.0±0.1 mm height , 4.0±0.1 mm diameter ) for compressive fracture testing , bars ( 25.0±0.1 mm length , 2.0±0.1 mm height , 2.0±0.1 mm width ) for three point flexure testing and discs ( 13.0±0.1 mm diameter , 1.0±0.1 mm thickness ) for biaxial flexure testing were r and omly prepared by an operator . The strength data sets for each GI restorative were pooled and one-way analyses of variance ( ANOVAs ) were conducted to compare between GI restoratives ( p=0.05 ) . The coefficient of variation ( CoV ) values for each test were pooled and a one-way ANOVA was conducted to test for differences between the reliability of the three tests . RESULTS For the GI restoratives , the one-way ANOVA showed significant differences when tested in compression ( p=0.001 ) but not when tested in three point ( p=0.271 ) or biaxial ( p=0.134 ) flexure . The pooled CoV values showed no significant difference between the three strength tests ( p=0.632 ) . CONCLUSIONS The compressive fracture strength test specified for GIs in the International Organisation for St and ardisation ( ISO 9917 - 1 : 2003 ) should be replaced and should no longer be advocated for the predictive performance modelling of GI restoratives",
"Objective : This study evaluated the effect of antiasthmatic medication on the surface roughness and color stability of dental restorative material s. Material s and Methods : A total of 60 disc-shaped specimens were fabricated from glass ionomer ( n = 20 ) , composite resin ( n = 20 ) and feldspathic porcelain ( n = 20 ) . Each material group was r and omly divided into two subgroups ( n = 10 ) : ( 1 ) control group and ( 2 ) test group . Control groups of the specimens were kept in artificial saliva . Test groups were exposed to salbutamol sulfate ( Ventolin Nebules ) using an inhaler machine . Surface roughness measurements were done using a profilometry and color measurements were done with digital colorimetry at baseline and after inhalation and storing in artificial saliva . A two-way analysis of variance ( ANOVA ) and post-hoc Fisher 's least significant difference test were used to compare the change in surface roughness and color . The confidence level was set at 95 % . Results : Inhaler treatment significantly increased the surface roughness and color change of glass ionomer and composite resin material s ( p surface roughness and color of feldspathic porcelain was not changed after inhaler treatment ( p > 0.05 ) . Conclusion : The antiasthmatic inhaler medication ( salbutamol sulfate ) affected the surface roughness and color of composite resin and glass ionomer restorative material",
"Six fluoride-releasing material s of shade A3 were tested : one glass ionomer ( Fuji IX ) , one resin-modified glass ionomer ( Photac-Fil ) , two compomers ( F 2000 and Dyract AP ) and two composites ( Tetric Ceram and Solitaire ) . Disk-shaped specimens of each material were prepared according to manufacturer 's instructions , polished and L*a*b * baseline measurements taken . Specimens were r and omly divided into two groups and given four different treatments of UV light exposure and immersion in a staining solution . Chromo Meter color measurements were taken following each treatment . Two-way ANOVA and Duncan Multiple Range post-hoc tests were used to compare color changes as a function of the four treatment conditions and one-way ANOVA was used to compare material s for each treatment separately . The results showed significant difference in shade A3 between products . In general , the hydrophobic material s showed greater color stability and stain resistance than the hydrophilic material s. Tetric ceram had the best color stability and stain resistance , while Fuji IX had the least"
] | 41162928-06ff-11f0-808a-c43d1ab1c353 |
Background C-reactive protein ( CRP ) and lipoprotein ( a ) ( Lp[a ] ) play essential roles in cardiovascular disease incidence . This study aim ed to review the association between the intake of conjugated linoleic acid ( CLA ) in the form of dietary supplement or enriched food with different treatment duration s and the levels of Lp(a ) and CRP in human studies . Methods All the articles published in Cochrane Library , ProQuest , Scopus , and Google Scholar from November 2014 to October 2015 were search ed and the clinical trials on the effects of CLA on Lp(a ) and CRP levels were assessed . Of the 2249 articles initially retrieved , 21 eligible r and omized clinical trials were enrolled in this systematic review . The publication date s of the eligible articles ranged from 2005 to 2013 . The mean difference and the st and ard deviation of changes in CRP and Lp(a ) levels in intervention and control groups were used as effect-size measures for meta- analysis . The obtained data from the eligible r and omized controlled trials were meta-analyzed using Stata , version 13 . Results The intake of CLA as a dietary supplement led to a significant increase in CRP levels ( st and ardized mean difference [SMD]=0.41 , 95 % CI : 0.28 to 0.54 ; P=0.001 ) . Subgroup analysis based on the duration of CLA consumption showed that CLA consumption more than 24 weeks result ed in a significant increase in the levels of CRP ( SMD=0.52 , 95 % CI : 0.36 to 0.68 ; P=0.001 ) and Lp(a ) ( SMD=0.24 , 95 % CI : 0.01 to 0.47 ; P=0.04 ) . Conclusion The current systematic review and meta- analysis showed that the long-term consumption of CLA increases the levels of CRP and Lp(a ) | [
"Immune-modulating effects of CLA have been reported in animals , but results are inconsistent . In humans , CLA has shown no effects or only minor effects on immune function . The objective of this study was to evaluate the immune-modulating effects of 3 g cis-9,trans-11 ( c9,t11 ) vs. trans-10,cis-12 ( t10,c12 ) CLA isomers in a population with a high risk of coronary heart disease characterized by moderate overweight ( body-mass index , 25–32.5 kg/m2 ) in combination with LDL-phenotype B ( ≥35 % small LDL cholesterol , density≥1.040 g/mL ) . After a run-in period of 1 wk , 42 men and women were r and omly allocated to the c9,t11 CLA group , the t10,c12 CLA group , or the placebo group . Effects of 13 wk of consumption of 3 g of CLA isomers on cytokine production by ex vivo lipopolysaccharide (LPS)-stimulated peripheral blood mononuclear cells ( P BMC ) and whole blood , and on plasma C-remononuclear protein ( CRP ) concentrations were evaluated . To generate hypotheses for future studies , protein expression patterns of 42 cytokines , chemokines , and growth factors were evaluated with an antibody array in pooled , nonstimulated , fasting plasma sample s. LPS induced interleukin (IL)-6 , IL-8 , and tumor necrosis factor-α production by P BMC , and whole blood as well as plasma CRP concentrations were not significantly changed by the c9,t11 , and the t10,c12 CLA isomers . The cytokine expression profile in nonstimulated plasma suggested that both CLA isomers induced a specific inflammatory signature , in which the c9,t11 CLA group showed more activity in terms of numbers of proteins regulated . We conclude that daily consumption of 3 g of c9,t11 or t10,c12 CLA isomer did not affect LPS-stimulated cytokine production by P BMC or whole blood and plasma CRP levels . Inflammatory signatures in fasting , nonstimulated plasma as determined by an antibody array may indicate enhanced immune function by both CLA isomers",
"After 12 mo in a r and omized , double-blind , placebo-controlled trial of conjugated linoleic acid ( CLA ) supplementation ( 2 groups received CLA as part of a triglyceride or as the free fatty acid , and 1 group received olive oil as placebo ) , 134 of the 157 participants who concluded the study were included in an open study for another 12 mo . The goals of the extension study were to evaluate the safety [ with clinical chemistry analyses and reported adverse events ( AEs ) ] and assess the effects of CLA on body composition [ body fat mass ( BFM ) , lean body mass ( LBM ) , bone mineral mass ( BMM ) ] , body weight , and BMI . All subjects were supplemented with 3.4 g CLA/d in the triglyceride form . Circulating lipoprotein(a ) and thrombocytes increased in all groups . There was no change in fasting blood glucose . Aspartate amino transferase , but not alanine amino transferase , increased significantly . Plasma total cholesterol and LDL cholesterol were reduced , whereas HDL cholesterol and triglycerides were unchanged . The AE rate decreased compared with the first 12 mo of the study . Body weight and BFM were reduced in the subjects administered the placebo during the initial 12 mo study ( -1.6 + /- 3.2 and -1.7 + /- 2.8 kg , respectively ) . No fat or body weight changes occurred in the 2 groups given CLA during the initial 12 mo . LBM and BMM were not affected in any of the groups . Changes in body composition were not related to diet and /or training . In conclusion , this study shows that CLA supplementation for 24 mo in healthy , overweight adults was well tolerated . It confirms also that CLA decreases BFM in overweight humans , and may help maintain initial reductions in BFM and weight in the long term",
"BACKGROUND The intake of trans fatty acids ( TFA ) from industrially hydrogenated vegetable oils ( iTFA ) is known to have a deleterious effect on cardiovascular health , the effects of TFA from ruminants ( rTFA ) are virtually unknown . OBJECTIVE The purpose of the present study was to compare the effects of rTFA and iTFA on plasma LDL concentrations and other cardiovascular disease risk factors in healthy subjects . DESIGN In a double-blind , r and omized crossover controlled study , 38 healthy men were fed each of 4 experimental isoenergetic diets lasting 4 wk each . The 4 diets were high in rTFA ( 10.2 g/2500 kcal ) , moderate in rTFA ( 4.2 g/2500 kcal ) , high in iTFA ( 10.2 g/2500 kcal ) , and low in TFA from any source ( 2.2 g/2500 kcal ) ( control diet ) . RESULTS Plasma LDL-cholesterol concentrations were significantly higher after the high- rTFA diet than after the control ( P = 0.03 ) or the moderate- rTFA ( P = 0.002 ) diet . Plasma LDL-cholesterol concentrations also were significantly ( P = 0.02 ) higher after the iTFA diet than after the moderate-rTFA diet . Plasma HDL-cholesterol concentrations were significantly ( P = 0.02 ) lower after the high-rTFA diet than after the moderate-rTFA diet . Finally , all risk factors were comparable between the control and the moderate-rTFA diets . CONCLUSIONS These results suggest that , whereas a high dietary intake of TFA from ruminants may adversely affect cholesterol homeostasis , moderate intakes of rTFA that are well above the upper limit of current human consumption have neutral effects on plasma lipids and other cardiovascular disease risk factors",
"A mixture of trans-10 , cis-12 ( t10,c12 ) and cis-9 , trans-11 ( c9,t11 ) conjugated linoleic acid ( CLA mixture ) reduced atherosclerosis in animals , thus the effect of these isomers on endothelial dysfunctions leading to inflammation and atherosclerosis is of interest . We gave 75 healthy postmenopausal women a daily supplement of 5.5 g of oil rich in either CLA mixture , an oil rich in the naturally occurring c9,t11 CLA ( CLA milk ) , respectively , or olive oil for 16 wk in a double-blind , r and omized , parallel intervention study . We sample d blood and urine before and after the intervention . The ratios of total cholesterol : HDL cholesterol and concentrations of C-reactive protein , fibrinogen , and plasminogen activator inhibitor-1 were significantly higher in women supplemented with the CLA mixture than in those supplemented with CLA milk . Plasma triacylglycerol was significantly higher and HDL cholesterol was lower in women supplemented with the CLA mixture than with olive oil . Both CLA supplements increased lipid peroxidation , a marker of in vivo oxidative stress measured as urinary free 8-iso-prostagl and in F(2alpha ) . However , the CLA mixture increased lipid peroxidation more than the CLA milk did . The plasma cytokines interleukin-6 and tumor necrosis factor-alpha were not affected by the treatments , nor were any of the other variables measured . In conclusion , oil containing trans-10,cis-12 CLA has several adverse effects on classical and novel markers of coronary vascular disease , whereas the c9,t11 CLA isomer is more neutral , except for a small but significant increase in lipid peroxidation compared with olive oil",
"BACKGROUND Animal studies have suggested that conjugated linoleic acid ( CLA ) , a natural component of ruminant meat and dairy products , may confer beneficial effects on health . However , little information on the effects of CLA on immune function is available , especially in humans . Furthermore , the effects of individual isomers of CLA have not been adequately investigated . OBJECTIVE This study investigated the effects of supplementing the diet with 3 doses of highly enriched cis-9,trans-11 CLA ( 0.59 , 1.19 , and 2.38 g/d ) or trans-10,cis-12 CLA ( 0.63 , 1.26 , and 2.52 g/d ) on immune outcomes in healthy humans . DESIGN The study had a r and omized , double-blind , crossover design . Healthy men consumed 1 , 2 , and 4 capsules sequentially that contained 80 % of either cis-9,trans-11 CLA or trans-10,cis-12 CLA for consecutive 8-wk periods . This regimen was followed by a 6-wk washout and a crossover to the other isomer . RESULTS Both CLA isomers decreased mitogen-induced T lymphocyte activation in a dose-dependent manner . There was a significant negative correlation between mitogen-induced T lymphocyte activation and the proportions of both cis-9,trans-11 CLA and trans-10,cis-12 CLA in peripheral blood mononuclear cell lipids . However , CLA did not affect lymphocyte sub population s or serum concentrations of C-reactive protein and did not have any consistent effects on ex vivo cytokine production . CONCLUSION CLA supplementation results in a dose-dependent reduction in the mitogen-induced activation of T lymphocytes . The effects of cis-9,trans-11 CLA and trans-10,cis-12 CLA were similar , and there was a negative correlation between mitogen-induced T lymphocyte activation and the cis-9,trans-11 CLA and trans-10,cis-12 CLA contents of mononuclear cells",
"Conjugated linoleic acid ( CLA ) has been shown to reduce body fat mass ( BFM ) in animals . To investigate the dose-response relationships of conjugated linoleic acid with regard to BFM in humans , a r and omized , double-blind study including 60 overweight or obese volunteers ( body mass index 25 - 35 kg/m(2 ) ) was performed . The subjects were divided into five groups receiving placebo ( 9 g olive oil ) , 1.7 , 3.4 , 5.1 or 6.8 g conjugated linoleic acid per day for 12 wk , respectively . Dual-energy X-ray absorptiometry was used to measure body composition [ measurements at wk 0 ( baseline ) , 6 and 12 ] . Of the 60 subjects , 47 completed the study . Eight subjects withdrew from the study due to adverse events ; however , no differences among treatment groups were found regarding adverse events . Repeated- measures analysis showed that a significantly higher reduction in BFM was found in the conjugated linoleic acid groups compared with the placebo group ( P : = 0.03 ) . The reduction of body fat within the groups was significant for the 3.4 and 6.8 g CLA groups ( P : = 0.05 and P : = 0.02 , respectively ) . No significant differences among the groups were observed in lean body mass , body mass index , blood safety variables or blood lipids . The data suggest that conjugated linoleic acid may reduce BFM in humans and that no additional effect on BFM is achieved with doses > 3.4 g CLA/d",
"Conjugated linoleic acid ( CLA ) alters body composition in animal models , but few studies have examined the effects of CLA supplementation on body composition and clinical safety measures in obese humans . In the present study , we performed a r and omized , double-blind , placebo-controlled trial to examine the changes in body composition and clinical laboratory values following CLA ( 50:50 ratio of cis-9 , trans-11 and trans-10 , cis-12 isomers ) supplementation for 12 wk in otherwise healthy obese humans . Forty-eight participants ( 13 males and 35 females ) were r and omized to receive placebo ( 8 g safflower oil/d ) , 3.2 g/d CLA , or 6.4 g/d CLA for 12 wk . Changes in body fat mass and lean body mass were determined by dual-energy X-ray absorptiometry . Resting energy expenditure was assessed by indirect calorimetry . Clinical laboratory values and adverse-event reporting were used to monitor safety . Lean body mass increased by 0.64 kg in the 6.4 g/d CLA group ( P serum HDL-cholesterol and sodium , hemoglobin , and hematocrit , and significant increases in serum alkaline phosphatase , C-reactive protein , and IL-6 , and white blood cells occurred in the 6.4 g/d CLA group , although all values remained within normal limits . The intervention was well tolerated and no severe adverse events were reported , although mild gastrointestinal adverse events were reported in all treatment groups . In conclusion , whereas CLA may increase lean body mass in obese humans , it may also increase markers of inflammation in the short term",
"BACKGROUND Short-term trials showed that conjugated linoleic acid ( CLA ) may reduce body fat mass ( BFM ) and increase lean body mass ( LBM ) , but the long-term effect of CLA was not examined . OBJECTIVE The objective of the study was to ascertain the 1-y effect of CLA on body composition and safety in healthy overweight adults consuming an ad libitum diet . DESIGN Male and female volunteers ( n = 180 ) with body mass indexes ( in kg/m(2 ) ) of 25 - 30 were included in a double-blind , placebo-controlled study . Subjects were r and omly assigned to 3 groups : CLA-free fatty acid ( FFA ) , CLA-triacylglycerol , or placebo ( olive oil ) . Change in BFM , as measured by dual-energy X-ray absorptiometry , was the primary outcome . Secondary outcomes included the effects of CLA on LBM , adverse events , and safety variables . RESULTS Mean ( + /- SD ) BFM in the CLA-triacylglycerol and CLA-FFA groups was 8.7 + /- 9.1 % and 6.9 + /- 9.1 % , respectively , lower than that in the placebo group ( P LBM than did subjects receiving placebo ( P = 0.002 ) . These changes were not associated with diet or exercise . LDL increased in the CLA-FFA group ( P = 0.008 ) , HDL decreased in the CLA-triacylglycerol group ( P = 0.003 ) , and lipoprotein(a ) increased in both CLA groups ( P Fasting blood glucose concentrations remained unchanged in all 3 groups . Glycated hemoglobin rose in all groups from month 0 concentrations , but there was no significant difference between groups . Adverse events did not differ significantly between groups . CONCLUSION Long-term supplementation with CLA-FFA or CLA-triacylglycerol reduces BFM in healthy overweight adults",
"BACKGROUND Animal studies suggest that dietary cis-9,trans-11 ( c9,t11 ) conjugated linoleic acid ( CLA ) may inhibit or regress the development of atherosclerosis . The effect of CLA on atherosclerosis has not been assessed in humans . OBJECTIVE We investigated the effect of c9,t11 CLA supplementation on aortic pulse wave velocity ( a marker of atherosclerosis ) and on cardiovascular risk factors in overweight and obese but otherwise apparently healthy subjects . DESIGN In a double-blind , r and omized , placebo-controlled , parallel-group trial , we r and omly assigned 401 subjects , aged 40 - 70 y and with a body mass index ( in kg/m(2 ) ) > or = 25 , to receive either 4 g CLA/d ( 2.5 g c9,t11 CLA/d and 0.6 g trans-10,cis-12 CLA/d ) or placebo supplements for 6 mo . Aortic pulse wave velocity , blood pressure , anthropometric characteristics , and concentrations of fasting lipid , glucose , insulin , and C-reactive protein were measured before and after supplementation . RESULTS During the intervention , mean ( + /-SE ) pulse wave velocity did not change in the c9,t11 CLA group ( Delta0.00 + /- 0.07 ) compared with the placebo group ( Delta0.09 + /- 0.06 ) . There was no effect of c9,t11 CLA supplementation on blood pressure , body composition , insulin resistance , or concentrations of lipid , glucose , and C-reactive protein . CONCLUSION This study does not support an antiatherosclerotic effect or an effect on cardiovascular risk factors of c9,t11 CLA . This trial was registered at www . clinical trials.gov as NCT00706745",
"INTRODUCTION Conjugated linoleic acids ( CLAs ) have shown beneficial effects in weight control therapy however this relation is not clear . OBJETIVE The aim of the study was to examine the effects and safety of 3 g of a 1:1 mix of c9-t11 and t10-c12 on weight control and body composition in healthy overweight individuals . METHODS A prospect i ve , placebo-controlled , r and omised double-blind , parallel clinical trial lasting 24 weeks was carried out in 38 volunteers ( 29w , 9 m ) aged 30 - 55 years and BMI ≥27- skimmed milk with 3 g of CLAs or 3 g olive oil ( placebo ) . Anthropometric , biochemical and dual x-ray absorptiometry ( DXA ) tests were measured . Diet and physical activity were assessed . RESULTS Subjects maintained their habitual dietary and exercise patterns over the study . Only CLA group showed a significant decrease in weight ( 74.43 ± 10.45 vs 73.54 ± 11.66 kg , p = 0.029 ) and waist circumference ( 91.45 ± 10.33 vs 90.65 ± 9.84 cm , p = 0.012 ) between baseline and end of the study . BMI and waist height ratio decreased ( 28.44 ± 1.08 vs 27.81 ± 1.43 kg/m2 , p = 0.030 and 0.57 ± 0.05 vs 0.56 ± 0.04 p = 0.013 respectively ) in CLA group at the end . CLA group experienced a reduction in total fat mass after 24 weeks ( 38.62 ± 5.02 vs 36.65 ± 5.64 % , p = 0.035 ) . No decrease was observed in Control group . HOMA index had no changes . CONCLUSIONS The consumption of skimmed milk enriched with 3 g of a 1:1 mixture of c9-t11 and t10-c12 for 24 weeks led to a decrease in body weight and total fat mass in healthy , overweight subjects who maintained habitual diets and exercise patterns . No adverse effects were observed . Registered under Clinical Trials.gov Identifier No. NCT01503047",
"Consumption of industrial trans fatty acids ( iTFA ) increases LDL cholesterol , decreases HDL cholesterol , and is strongly associated with a higher risk of cardiovascular disease ( CVD ) . However , changes in circulating cholesterol can not explain the entire effect . Therefore , we studied whether iTFA and conjugated linoleic acid ( CLA ) affect markers of inflammation and oxidative stress . Sixty-one healthy adults consumed each of 3 diets for 3 wk , in r and om order . Diets were identical except for 7 % of energy provided by oleic acid ( control diet ) , iTFA , or CLA . At the end of the 3 wk , we measured plasma inflammatory markers IL-6 , C-reactive protein , tumor necrosis factor receptors I and II ( TNF-RI and -RII ) , monocyte chemotactic protein-1 and E-selectin , and urinary 8-iso-PGF(2α ) , a marker of lipid peroxidation . Consumption of iTFA caused 4 % lower TNF-RI concentrations and 6 % higher E-selectin concentrations compared with oleic acid ( control ) and had no significant effect on other inflammatory markers . CLA did not significantly affect inflammatory markers . The urine concentration of 8-iso-PGF(2α ) [ geometric mean ( 95 % CI ) ] was greater after the iTFA [ 0.54 ( 0.48 , 0.60 ) nmol/mmol creatinine ] and the CLA [ 1.2 ( 1.1 , 1.3 ) nmol/mmol creatinine ] diet periods than after the control period [ 0.45 ( 0.41 , 0.50 ) nmol/mmol creatinine ; P iTFA and CLA did not substantially affect plasma concentrations of inflammatory markers , but they increased the urine 8-iso-PGF(2α ) concentration . However , it is unlikely this plays a major role in the mechanism by which iTFA increase the risk of CVD . However , more research is needed to fully underst and the implication s of these findings",
"BACKGROUND Results of a pilot study suggested that cis-9 , trans-11 conjugated linoleic acid ( CLA ) improved LDL phenotype in moderately overweight subjects with LDL phenotype B. OBJECTIVE Initiated by the results of this pilot study , we have specifically design ed a study to test the hypothesis that cis-9 , trans-11 conjugated linoleic acid improves LDL phenotype in moderately overweight subjects with LDL phenotype B. Effects on the serum lipid profile , on plasma glucose and insulin concentrations , and on clinical parameters were also examined . DESIGN Volunteers with LDL phenotype B were divided into three groups consuming daily a drinkable dairy product not enriched with CLA ( placebo , n = 34 ) , the same dairy product enriched with 3 g c9 , t11 CLA ( n = 34 ) , or the dairy product enriched with 3 g t10 , c12 CLA ( n = 19 ) for 13 weeks . RESULTS Median changes in the proportions of plasma small dense LDL were -2.0 % in the control group and -0.1 % in the c9 , t11 CLA and t10 , c12 CLA groups ( p = 0.981 for the differences between the groups ) . c9 , t11 CLA or t10 , c12 CLA did also not affect serum concentrations of LDL and HDL cholesterol , and of triacylglycerol , and plasma concentrations of glucose and insulin . CONCLUSIONS In humans with LDL phenotype B , c9 , t11 CLA and t10 , c12 CLA do not beneficially change risk factors for cardiovascular disease or diabetes",
"Objectives —To determine the effect of dietary supplementation with conjugated linoleic acid ( CLA ) on body mass index ( BMI ) , body fat distribution , endothelial function , and markers of cardiovascular risk . Methods and Results —Forty healthy volunteers with BMI > 27 kg/m2 were r and omized to receive a CLA isomeric mixture or olive oil in a 12-week double-blind study . Subcutaneous body fat and abdominal/hepatic fat content were assessed using skin-fold thicknesses and computed tomography scanning , respectively . Endothelial function was assessed by brachial artery flow-mediated dilatation ( FMD ) . Plasma isoprostanes were measured as an index of oxidative stress . CLA supplementation did not result in a significant change in BMI index or total body fat . There was a significant decrease in limb ( −7.8 mm , P but not torso skin-fold thicknesses or abdominal or liver fat content . Brachial artery FMD declined ( −1.3 % , P=0.013 ) , and plasma F2-isoprostanes increased ( + 91pg/mL , P=0.042 ) . Conclusions —A CLA isomeric mixture had at most modest effects on adiposity and worsened endothelial function . On the basis of these results , the use of the isomeric mixture of CLA as an aid to weight loss can not be recommended",
"Aging is associated with lower muscle mass and an increase in body fat . We examined whether creatine monohydrate ( CrM ) and conjugated linoleic acid ( CLA ) could enhance strength gains and improve body composition ( i.e. , increase fat-free mass ( FFM ) ; decrease body fat ) following resistance exercise training in older adults ( > 65 y ) . Men ( N = 19 ) and women ( N = 20 ) completed six months of resistance exercise training with CrM (5g/d)+CLA ( 6g/d ) or placebo with r and omized , double blind , allocation . Outcomes included : strength and muscular endurance , functional tasks , body composition ( DEXA scan ) , blood tests ( lipids , liver function , CK , glucose , systemic inflammation markers ( IL-6 , C-reactive protein ) ) , urinary markers of compliance ( creatine/creatinine ) , oxidative stress ( 8-OH-2dG , 8-isoP ) and bone resorption ( Ν-telopeptides ) . Exercise training improved all measurements of functional capacity ( P and strength ( P in most measurements of muscular endurance , isokinetic knee extension strength , FFM , and lower fat mass ( P ( P not creatinine clearance , increased for CrM+CLA , with no changes in serum CK activity or liver function tests . Together , this data confirms that supervised resistance exercise training is safe and effective for increasing strength in older adults and that a combination of CrM and CLA can enhance some of the beneficial effects of training over a six-month period . Trial Registration . Clinical Trials.gov",
"Long-term supplementation with conjugated linoleic acid ( CLA ) reduces body fat mass ( BFM ) and increases or maintains lean body mass ( LBM ) . However , the regional effect of CLA was not studied . The study aim ed to evaluate the effect of CLA per region and safety in healthy , overweight and obese adults . A total of 118 subjects ( BMI : 28 - 32 kg/m2 ) were included in a double blind , placebo-controlled trial . Subjects were r and omised into two groups supplemented with either 3 x 4 g/d CLA or placebo for 6 months . CLA significantly decreased BFM at month 3 ( Delta=- 0 x 9 % , P=0 x 016 ) and at month 6 ( Delta=- 3 x 4 % , P=0 x 043 ) compared with placebo . The reduction in fat mass was located mostly in the legs ( Delta=- 0 x 8 kg , P 30 kg/m2 ( Delta=-1 x 9 kg , P=0 x 011 ) , compared with placebo . The waist-hip ratio decreased significantly ( P=0 x 043 ) compared with placebo . LBM increased ( Delta=+0 x 5 kg , P=0 x 049 ) within the CLA group . Bone mineral content was not affected ( P=0 x 70 ) . All changes were independent of diet and physical exercise . Safety parameters including blood lipids , inflammatory and diabetogenic markers remained within the normal range . Adverse events did not differ between the groups . It is concluded that supplementation with CLA in healthy , overweight and obese adults decreases BFM in specific regions and is well tolerated",
"Background / Objectives : Dietary addition of either conjugated linoleic acid ( CLA ) or n-3 long-chain polyunsaturated fatty acids ( n-3 LC-PUFAs ) has been shown to alter adiposity and circulating lipids , risk markers of cardiovascular diseases . However , CLA may decrease insulin sensitivity , an effect that may be reversed by n-3 LC-PUFA . Thus , the potential of CLA plus n-3 LC-PUFA to affect insulin secretion and sensitivity in non-diabetic young and old , lean and obese subjects was tested . Subjects/ Methods : CLA ( 3 g daily ) plus n-3 LC-PUFA ( 3 g daily ) or control oil ( 6 g daily ) was given to lean ( n=12 ; BMI 20–26 kg/m2 ) or obese ( n=10 ; BMI 29–35 kg/m2 ) young ( 20–37 years old ) or lean ( n=16 ) or obese ( n=11 ) older men ( 50–65 years ) for 12 weeks . The study had a double-blind , placebo-controlled r and omized crossover design , and primary end points were insulin secretion and sensitivity during a st and ardized meal test , evaluated by modeling glucose , insulin and C-peptide data . Results : The combination was well tolerated . There was no significant difference in fasting levels of glucose , insulin or C-peptide after CLA/n-3 LC-PUFA treatment compared with control oil . Neither insulin secretion nor estimated sensitivity was affected by CLA/n-3 LC-PUFA in lean or obese young subjects or in older lean subjects . However , in older obese subjects , estimated insulin sensitivity was reduced with CLA/n-3 LC-PUFA compared with control ( P=0.024 ) . Conclusions : The results do not support beneficial effects of CLA/n-3 LC-PUFA for β-cell dysfunction or insulin resistance in humans but suggest that insulin sensitivity in older obese subjects is reduced",
"Objective : The incidence of obesity and overweight in the US has increased considerably during the past two decades and currently affects 65 % of the adult population . Research has indicated that small , yet irreversible , gains during the holiday season contribute to increases in weight during adulthood . Conjugated linoleic acid ( CLA ) , a naturally occurring dietary fatty acid , has been found to reduce weight gain and dramatically decrease fat mass in animals . Although research in humans has shown inconsistent results , most studies have been of insufficient duration or have utilized body composition methods that are less accurate than the currently accepted criterion . Design : R and omized , double-blind , placebo-controlled study of 3.2 g/day CLA for 6 months . Subjects : Forty healthy , overweight subjects ( age : 18–44 years ; body mass index : 25–30 kg/m2 ) Measurements : Body composition by the four-compartment model , resting metabolic rate ( RMR ) by indirect calorimetry , self-reported physical activity and dietary intake , and blood chemistries were determined at baseline and after 6 months . Body weight was measured monthly during the pre-holiday season ( August – October ) , holiday season ( November – December ) and post-holiday season ( January – March ) . Adverse events were assessed monthly . Results : Compared to CLA , the placebo group showed a greater rate of weight gain during the holiday season ( P=0.01 ) . Within the placebo group , holiday weight change was significantly greater compared to the pre-holiday period ( August – October ) ( P=0.03 ) . Six-month change in body composition was improved with CLA compared to placebo ( P=0.02 ) , and body fat was significantly reduced within the CLA group ( −1.0±2.2 kg , P=0.05 ) . CLA had no effect on RMR , physical activity or dietary intake . The rate of reported negative emotions decreased significantly with CLA , although there was no difference in any other category of adverse event . In comparison to the placebo , CLA did not affect insulin resistance , blood lipids and markers of liver function or markers of inflammation , with the exception of a significant decrease in a biomarker of endothelial dysfunction . Conclusion : CLA supplementation among overweight adults significantly reduced body fat over 6 months and prevented weight gain during the holiday season . Although no adverse effects were seen , additional studies should evaluate the effect of prolonged use of CLA",
"Conjugated linoleic acid ( CLA ) may decrease adiposity and improve blood lipid profiles under some conditions . The goal of this study was to determine the effects of CLA supplementation on blood lipid profiles and adiposity of rats fed a diet containing a primarily saturated fat versus a diet containing a primarily unsaturated fat . Twenty-eight male Sprague-Dawley rats were r and omly assigned to one of four diets containing coconut oil , coconut oil with CLA , corn oil or corn oil with CLA . After 28 days , blood was collected and serum concentrations of total cholesterol ( TC ) , HDL-cholesterol ( HDL-C ) , and triacylglycerols ( TG ) were assessed . Food intake , body weights , and epididymal fat pads were measured . No significant differences ( p>0.05 ) were noted among groups for amount of food consumed , weight gained , food efficiency ratio or serum TG concentrations . TC concentrations were lower ( p CLA-supplemented rats that were fed coconut oil but not those consuming corn oil . Serum HDL-C was lower ( p0.05 ) for CLA supplemented groups . Epididymal fat pads weighed significantly more ( p0.05 ) between the corn oil and coconut oil + CLA group . Overall , this study suggests that CLA is more beneficial for control of blood lipids and adiposity when supplemented to a diet rich in saturated versus unsaturated fat",
"Isomers of conjugated linoleic acids ( CLA ) reduce fat mass ( FM ) and increase insulin sensitivity in some , but not all , murine studies . In humans , this effect is still debatable . In this study , we compared the effect of 2 CLA supplements on total and regional FM assessed by dual energy X-ray absorptiometry , changes in serum insulin and glucose concentrations , and adipose tissue ( AT ) gene expression in humans . In a double-blind , parallel , 16-wk intervention , we r and omized 81 healthy postmenopausal women to 1 ) 5.5 g/d of 40/40 % of cis9,trans11-CLA ( c9,t11-CLA ) and trans10,cis12-CLA ( t10,c12-CLA ) ( CLA-mix ) ; 2 ) cis9 , trans11-CLA ( c9,t11-CLA ) ; or 3 ) control ( olive oil ) . We assessed all variables before and after the intervention . The CLA-mix group had less total FM ( 4 % ) and lower-body FM ( 7 % ) than the control ( P = 0.02 and serum insulin concentrations were greater in the CLA-mix group ( 34 % ) than the control group ( P = 0.02 ) in the highest waist circumference tertile only . AT mRNA expression of glucose transporter 4 , leptin , and lipoprotein lipase was lower , whereas expression of tumor necrosis factor-alpha was higher in the CLA-mix group than in the control group ( P total and lower-body FM in postmenopausal women and greater serum insulin concentrations in the highest waist circumference tertile . Future research is needed to confirm the insulin desensitizing effect of the CLA mixture and the effect on the mRNA expression of adipocyte-specific genes in humans",
"Although patients with type 2 diabetes have a high risk of death from cardiovascular disease ( CVD ) , the traditional risk factors do not fully explain this excess of mortality . In this regard , it would be of great interest to assess the role of nontraditional risk factors such as lipoprotein(a ) in cardiovascular mortality in diabetic patients . Danesh et al. ( 1 ) , in a meta- analysis including the prospect i ve studies published before 2000 , concluded that there was a clear association between lipoprotein(a ) and CVD in the general population . Further prospect i ve reports have demonstrated that lipoprotein(a ) is an independent predictor of the development of CVD ( 2–5 ) . However , little data exist on the clinical importance of lipoprotein(a ) in the diabetic population . We herein report a prospect i ve study to evaluate the relationship between lipoprotein(a ) levels and cardiovascular mortality in type 2 diabetic patients of Caucasian origin . One hundred twenty-two consecutive type 2 diabetic out patients of Caucasian origin attending the outpatient diabetic unit of a university hospital between April and May of 1993 were enrolled for a 10-year prospect i ve study . To avoid the possible transient increase of lipoprotein(a ) after starting insulin treatment ( 6 ) , all patients in whom insulin treatment was initiated in the months before the study were excluded . Patients with renal failure were also excluded . To assess evidence of macroangiopathy , we used the World Health Organization ( WHO ) protocol , which includes a detailed question naire and a 12-lead electrocardiogram ( 7,8 ) . By the end of the study , data were available from 100 patients . Of these , 29 had died ( 23 from CVD ) . Metabolic parameters",
"Objective : Conjugated linoleic acid ( CLA ) showed a wide range of beneficial biological effects with relevance for cardiovascular health in animal models and humans . Most human studies used olive oil as a reference . This study assessed the effect of CLA as compared with safflower oil on endothelial function and markers of cardiovascular risk in overweight and obese men . Heated safflower oil and olive oil were given for additional descriptive control . Methods : Eighty-five overweight men ( aged 45–68 years , body mass index 25–35 kg/m2 ) were r and omized to receive 4.5 g/d of the CLA isomeric mixture , safflower oil , heated safflower oil , or olive oil in a 4-week double-blind study . Endothelial function was assessed by peripheral arterial tonometry ( PAT ) index determination in the fasting and postpr and ial state ( i.e. , 4 hours after consumption of a fat- and sucrose-rich meal ) . Results : CLA as compared with safflower oil consumption did not impair fasting or postpr and ial PAT index but decreased body weight . CLA as compared with safflower oil did not change total , low-density lipoprotein ( LDL ) , or high-density lipoprotein ( HDL ) cholesterol ; triglycerides ; insulin sensitivity indices ; C-reactive protein ; soluble adhesion molecules ; oxidized LDL ; lipoprotein a ( Lp[a ] ) ; paraoxonase ; or platelet-activating factor acetylhydrolase ( PAF-AH ) activity , but significantly reduced arylesterase activity and increased concentrations of the F2-isoprostane 8-iso-prostagl and in F (PGF)2α . Conclusion : CLA did not impair endothelial function . Other parameters associated with metabolic syndrome and oxidative stress were not changed or were slightly improved . Results suggest that CLA does not increase cardiovascular risk . Increased F2-isoprostane concentrations in this context may not indicate increased oxidative stress",
"Conjugated linoleic acid ( CLA ) is shown to have chemoprotective properties in various experimental cancer models . CLA is easily oxidised and it has been suggested that an increased lipid oxidation may contribute to the antitumorigenic effects . This report investigates the urinary levels of 8‐iso‐PGF2α , a major isoprostane and 15‐keto‐dihydro‐PGF2α , a major metabolite of PGF2α , as indicators of non‐enzymatic and enzymatic lipid peroxidation after dietary supplementation of CLA in healthy human subjects for 3 months . A significant increase of both 8‐iso‐PGF2α and 15‐keto‐dihydro‐PGF2α in urine was observed after 3 months of daily CLA intake ( 4.2 g/day ) as compared to the control group ( P Conjugated linoleic acid had no effect on the serum α‐tocopherol levels . However , γ‐tocopherol levels in the serum increased significantly ( P=0.015 ) in the CLA‐treated group . Thus , CLA may induce both non‐enzymatic and enzymatic lipid peroxidation in vivo . Further studies of the mechanism behind , and the possible consequences of , the increased lipid peroxidation after CLA supplementation are urgently needed"
] | 41162964-06ff-11f0-808a-c43d1ab1c353 |
CONTEXT Recommended daily physical activity accumulated in short intervals ( e.g. , short activity bouts incorporated into organizational routine as part of the regular " conduct of business . " EVIDENCE ACQUISITION PubMed , MEDLINE , and Google Scholar data bases were search ed in August 2009 ( up date d search in February and July 2010 ) to identify relevant , peer- review ed journal articles and abstract s on school- , worksite- , and faith-based interventions of short , structurally integrated physical activity breaks . EVIDENCE SYNTHESIS The majority of interventions implemented daily physical activity bouts of 10 - 15 minutes in length . Schools were the most common setting s among the 40 published articles included in this review . The rigor of the studies varied by setting , with more than 75 % of worksite versus 25 % of school studies utilizing RCT design s. Studies focused on a broad range of outcomes , including academic/work performance indicators , mental health outcomes , and clinical disease risk indicators , in addition to physical activity level . Physical activity was the most commonly assessed outcome in school-based studies , with more than half of studies assessing and observing improvements in physical activity outcomes following the intervention . About a quarter of worksite-based studies assessed physical activity , and the majority found a positive effect of the intervention on physical activity levels . About half of studies also observed improvements in other relevant outcomes such as academic and work performance indicators ( e.g. , academic achievement , cognitive performance , work productivity ) ; psychosocial factors ( e.g. , stress , mood ) ; and clinical disease risk indicators ( e.g. , blood pressure , BMI ) . The average study duration was more than 1 year , and several reported outcomes at 3 - 6 years . CONCLUSIONS Interventions integrating physical activity into organizational routine during everyday life have demonstrated modest but consistent benefits , particularly for physical activity , and these are promising avenues of investigation . The proportionately longer-term outcomes available in these studies compared with individual-level studies suggest that physical activity promotion strategies at the organizational level may be more sustainable | [
"Mediation analyses in faith-based physical activity ( PA ) interventions targeting African-American adults are lacking . The purpose of this study was to examine the psychosocial mediators of a faith-based PA intervention with African-American adults . Churches were r and omly assigned to receive immediate or delayed ( 1-year later ) training in PA program implementation . A sub sample of participants from r and omly selected churches took part in telephone surveys at baseline and at 1 year . The primary outcome was percentage of participants meeting PA recommendations . MacKinnon 's product of coefficients was used to test for mediation . Participants ( n = 418 ) from 20 churches completed the baseline and 1-year follow-up surveys . There were no statistically significant changes in PA behavior at 1 year . The intervention had a marginally significant effect on increasing the amount of instrumental church support received by church members . However , none of the psychosocial variables tested were found to be significant mediators of the intervention . Mediation analyses provided insight into potential reasons as to why the Health-e-AME intervention did not change PA . The intervention did not successfully change the targeted mediators hypothesized to change PA . Potential reasons for these shortcomings as well as issues to address in future faith-based studies are discussed",
"OBJECTIVE To evaluate the effectiveness of a worksite health promotion program on improving cardiovascular disease risk factors . METHODS In St Louis , Missouri from 2005 to 2006 , 151 employees ( 134 F , 17 M , 81 % overweight/obese ) participated in a cohort-r and omized trial comparing assessment s + intervention ( worksite A ) with assessment s only ( worksite B ) for 1 year . All participants received personal health reports containing their assessment results . The intervention was design ed to promote physical activity and favorable dietary patterns using pedometers , healthy snack cart , WeightWatchers(R ) meetings , group exercise classes , seminars , team competitions , and participation rewards . Outcomes included BMI , body composition , blood pressure , fitness , lipids , and Framingham 10-year coronary heart disease risk . RESULTS 123 participants , aged 45+/-9 yr , with BMI 32.9+/-8.8 kg/m(2 ) completed 1 year . Improvements ( P fitness , blood pressure , and total- , HDL- , and LDL-cholesterol . Additional improvements occurred at worksite A in BMI , fat mass , Framingham risk score , and prevalence of the metabolic syndrome ; only the changes in BMI and fat mass were different between worksites . CONCLUSION A multi-faceted worksite intervention promoted favorable changes in cardiovascular disease risk factors , but many of the improvements were achieved with worksite health assessment s and personalized health reports in the absence of an intervention",
"Background Physical Activity Across the Curriculum ( PAAC ) is a 3-year elementary school-based intervention to determine if increased amounts of moderate intensity physical activity performed in the classroom will diminish gains in body mass index ( BMI ) . It is a cluster-r and omized , controlled trial , involving 4905 children ( 2505 intervention , 2400 control ) . Methods We collected both qualitative and quantitative process evaluation data from 24 schools ( 14 intervention and 10 control ) , which included tracking teacher training issues , challenges and barriers to effective implementation of PAAC lessons , initial and continual use of program specified activities , and potential competing factors , which might contaminate or lessen program effects . Results Overall teacher attendance at training sessions showed exceptional reach . Teachers incorporated active lessons on most days , result ing in significantly greater student physical activity levels compared to controls ( p Enjoyment ratings for classroom-based lessons were also higher for intervention students . Competing factors , which might influence program results , were not carried out at intervention or control schools or were judged to be minimal . Conclusion In the first year of the PAAC intervention , process evaluation results were instrumental in identifying successes and challenges faced by teachers when trying to modify existing academic lessons to incorporate physical activity",
"BACKGROUND This study exp and ed previous NIOSH-IRS research examining the effects of rest breaks and stretching exercises on symptoms and performance in data -entry workers . METHODS All workers spent 4 weeks with conventional breaks ( two 15 min breaks per day ) and 4 weeks with supplementary breaks ( two 15 min breaks plus four 5 min breaks per day ) . One-half were assigned at r and om to a group instructed to perform brief stretching exercises during breaks . The remainder comprised the \" no stretching \" ( control ) group . RESULTS 51 workers ( stretch group n = 21 ; no stretch group n = 30 ) completed the study symptom question naires . Discomfort and eyestrain were significantly lower with supplementary breaks , and supplementary breaks attenuated accumulation of discomfort and eyestrain during work sessions . Data -entry speed was significantly faster with supplementary breaks so that work output was maintained , despite replacing 20 min of work time with break time . In the stretch group , workers reported stretching during only 25 % of conventional breaks and 39 % of supplementary breaks , and no significant effects of stretching on discomfort or performance were observed . CONCLUSIONS These results provide further converging evidence that supplementary breaks reliably minimize discomfort and eyestrain without impairing productivity . Low compliance in performing stretches prevented valid assessment of stretching effects . Further research on stretching exercises and exercise compliance is warranted",
"Introduction Proactive worksite strategies that change the physical or sociocultural environment(s ) to incorporate obligatory physical activity may be necessary to engage sedentary people . This study describes implementation and evaluation of an intervention , Pausa para tu Salud ( Pause for Your Health ) , that integrated a brief period of group exercise into the workday . Methods An uncontrolled pretest – post-test study design tested the effects of integrating daily 10-minute exercise breaks during paid work time during January 2003 through January 2004 . A total of 335 Mexican Ministry of Health office workers provided baseline data as a part of routine annual clinical screening examinations . Results Baseline mean body mass index and waist circumferences were 27.8 kg/m2 and 87.6 cm for women and 26.6 kg/m2 and 89.7 cm for men . Complete data were available for 271 ( 80.9 % ) employees at 1-year follow-up . Two-tailed , paired t-test comparisons were used . Body mass index decreased by 0.32 kg/m2 ( P = .05 ) , and waist circumference by 1.6 cm ( P = .0009 ) overall . The body mass index decrease , however , was significant only for men ( −0.43 kg/m2 , P = .03 ) . Multivariate analyses revealed a significant decrease in diastolic blood pressure among women ( z = −2.04 , P = .042 ) . Conclusion The intervention was associated with significant improvements in both measures of body composition . Substantive health and organizational benefits may result from integrating brief periods of physical activity into the workday if these findings are replicated in r and omized controlled trials in other worksites",
"In summary , employees ' flexibility and mood showed modest improvements following the implementation of a plant-wide , 10-minute , daily flexibility and strength program . The initial six-week pilot study , administered prior to the plant-wide program implementation , successfully assessed program feasibility , assessed the efficiency of program implementation , identified administrative and logistical concerns , and generated pilot data needed to secure managerial support . Despite the noted significant increases in grip strength in the pilot study , no increases were observed following the six months of plant-wide implementation . This may be related to the differences in low average pretest grip strength for the pilot study compared to the higher scores for the main study population . The pilot study subjects may have received a sufficient exercise stimulus to increase grip strength over the course of six weeks . In contrast , this may not have been the case for the main study subjects due to their higher initial mean grip strength . An increased number of exercises design ed to directly impact grip strength may be needed to improve this parameter",
"The appropriateness of recess in the elementary program continues to be question ed although generally it is believed to be useful by elementary principals despite a dearth of supportive data . This study was a developmental study of the effects of physical activity on concentration . Comparison of passive and directed physical education activities on the concentration of second- , third- , and fourth- grade children was made . The Woodcock-Johnson Test of Concentration showed better performance by the fourth grade rs and within Grade 4 in favor of the physical activity group . A structured physical activity or a classroom activity immediately prior to a concentration task was not detrimental to children in Grade s 2 and 3 . Fourth- grade children performed significantly better on a test of concentration after engaging in a physical activity",
"Exercise during growth has a positive influence on bone mineral accrual , yet little is known about how bone geometry and strength adapt to loading during growth . Our primary objective was to compare changes in proximal femur bone geometry and strength between 31 prepubertal ( Tanner Stage 1 ) boys who participated in a school-based , high-impact circuit intervention ( 12 min , three times a week ) for 20 months and 33 maturity-matched controls . Our secondary objective was to compare changes in total body ( TB ) , proximal femur ( PF ) , and lumbar spine ( LS ) bone mineral content ( BMC ) and bone area ( BA ) in these groups . We assessed geometric variables and bone strength at the narrow neck ( NN ) , intertrochanteric ( TR ) region , and femoral shaft regions by applying the Hip Structure Analysis program to proximal femur dual energy X-ray absorptiometry scans ( DXA , Hologic QDR 4500 ) . Further , we assessed total body , lumbar spine , and proximal femur BMC and BA by DXA and derived total body lean mass and fat mass from total body scans . Intervention ( 10.2 + /- 0.5 years ) and control boys ( 10.1 + /- 0.5 years ) had similar baseline height ( 140.8 vs. 141.3 cm ) and weight ( 36.9 vs. 35.4 kg ) , and average 20-month physical activity scores ( Physical Activity Question naire for Children , PAQ-C ) and calcium intakes ( 861 vs. 852 mg/day , food frequency question naire ) . Twenty-month height and weight changes were not significantly different between groups ; lean mass changed more ( P intervention boys ( 22.8 % ) than control boys ( 18.6 % ) . At the NN region , intervention boys had greater bone expansion on both the periosteal ( + 2.6 % , P = 0.1 ) and endosteal ( + 2.7 % , P = 0.2 ) surfaces , result ing in significantly greater changes in section modulus ( bone bending strength ) ( + 7.5 % , P = 0.02 , ANCOVA , adjusting for height change , final Tanner Stage , and baseline bone values ) . Changes at the intertrochanteric and femoral shaft regions were not significantly different between groups . Femoral neck ( FN ) BMC changes were significantly greater in intervention boys ( + 4.3 % , P in BA and BMC for other regions were not significantly different between groups . In summary , a school-based , high-impact exercise intervention implemented three times a week for 12 min is an effective strategy for site-specific gains in bone strength at the narrow neck region of the proximal femur",
"OBJECTIVE The objective was to test the hypothesis that a community-based environmental change intervention could prevent weight gain in young children ( 7.6 + /- 1.0 years ) . RESEARCH METHODS AND PROCEDURES A non-r and omized controlled trial was conducted in three culturally diverse urban cities in Massachusetts . Somerville was the intervention community ; two socio-demographically-matched cities were control communities . Children ( n = 1178 ) in grade s 1 to 3 attending public elementary schools participated in an intervention design ed to bring the energy equation into balance by increasing physical activity options and availability of healthful foods within the before- , during- , after-school , home , and community environments . Many groups and individuals within the community ( including children , parents , teachers , school food service providers , city departments , policy makers , healthcare providers , before- and after-school programs , restaurants , and the media ) were engaged in the intervention . The main outcome measure was change in BMI z-score . RESULTS At baseline , 44 % ( n = 385 ) , 36 % ( n = 561 ) , and 43 % ( n = 232 ) of children were above the 85th percentile for BMI z-score in the intervention and the two control communities , respectively . In the intervention community , BMI z-score decreased by -0.1005 ( p = 0.001 , 95 % confidence interval , -0.1151 to -0.0859 ) compared with children in the control communities after controlling for baseline covariates . DISCUSSION A community-based environmental change intervention decreased BMI z-score in children at high risk for obesity . These results are significant given the obesigenic environmental backdrop against which the intervention occurred . This model demonstrates promise for communities throughout the country confronted with escalating childhood obesity rates",
"PURPOSE To present the development and feasibility testing of a sociocultural environmental change intervention strategy aim ed at integrating physical activity into workplace routine . DESIGN R and omized , controlled , post-test only , intervention trial . Setting . Los Angeles County Department of Health Services ' worksites . PARTICIPANTS Four hundred forty-nine employees , predominantly sedentary , overweight , middle-aged women of color , distributed across 26 meetings . INTERVENTION A single 10-min exercise break during work time involving moderate intensity , low-impact aerobic dance and calisthenic movements to music . MEASURES Primary -level of participation , particularly among sedentary staff ; secondary -self-perceived health status , satisfaction with current fitness level , and mood/affective state . RESULTS More than 90 % of meeting attendees participated in the exercises . Among completely sedentary individuals , intervention participants ' self-perceived health status ratings were significantly lower than controls ' ( OR = 0.17 ; 95 % CI = 0.05 , 0.60 ; P = 0.0003 ) . Among all respondents not regularly physically active , intervention participants ' levels of satisfaction with fitness were more highly correlated with self-ranked physical activity stage of change ( r = 0.588 ) than the control participants ' ( r = 0.376 , z = -2.32 , p = 0.02 ) . Among the completely sedentary , control participants reported significantly higher levels of energy than did intervention participants ( P < 0.01 ) . CONCLUSIONS Captive audiences may be engaged in brief bouts of exercise as a part of the workday , regardless of physical activity level or stage of change . This experience may also appropriately erode sedentary individuals ' self-perception of good health and fitness , providing motivation for adoption of more active lifestyles",
"The POWER PE study was an 8-mo , r and omized , controlled , school-based exercise intervention design ed to apply known principles of effective bone loading to practical opportunities to improve life-long musculoskeletal outcomes . A total of 99 adolescents ( 46 boys and 53 girls ) with a mean age of 13.8 + /- 0.4 yr ( peri- to postpubertal ) volunteered to participate . Intervention subjects performed 10 min of jumping activity in place of regular physical education ( PE ) warm up . Control subjects performed usual PE warm-up activities . Bone mass ( DXA and QUS ) was assessed at baseline and follow-up along with anthropometry , maturity , muscle power , and estimates of physical activity and dietary calcium . Geometric properties ( such as femoral neck [ FN ] moment of inertia ) were calculated from DXA measures . Boys in the intervention group experienced improvements in calcaneal broadb and ultrasound attenuation ( BUA ) ( + 5.0 % ) and fat mass ( -10.5 % ) , whereas controls did not ( + 1.4 % and -0.8 % , respectively ) . Girls in the intervention group improved FN BMC ( + 13.9 % ) and lumbar spine ( LS ) BMAD ( + 5.2 % ) more than controls ( + 4.9 % and + 1.5 % , respectively ) . Between-group comparisons of change showed intervention effects only for whole body ( WB ) BMC ( + 10.6 % versus + 6.3 % ) for boys . Boys in the intervention group gained more lean tissue mass , trochanter ( TR ) BMC , LS BMC , and WB BMC and lost more fat mass than girls in the intervention group ( p bone accrual in a sex-specific manner . Boys increased WB bone mass and BUA , and reduced fat mass , whereas girls improved bone mass at the hip and spine",
"OBJECTIVE Childhood weight-bearing physical activity is recognized as an important determinant of peak bone mass , and physical activity intervention may represent a feasible strategy for primary prevention of osteoporosis . Previous school-based exercise interventions have all been of high-impact , circuit-based , jumping intervention ( 10 minutes , 3 times a week ) over 2 school years and compared changes in bone mineral content ( BMC ) over 20 months ( 2 school years ) in 9.9 + /- 0.6-year-old intervention girls ( N = 32 ) and controls ( 10.3 + /- 0.4 years , N = 43 ) . METHODS We measured BMC for the total body , lumbar spine , proximal femur ( and femoral neck and trochanteric subregions ) , and lean and fat mass by dual-energy radiograph absorptiometry ( Hologic QDR 4500 ) , and height , sitting height , leg length , and weight at baseline and 20 months . We assessed Tanner stage , general physical activity , and calcium intake by question naire . RESULTS Girls were Tanner breast stage 1 to 3 at baseline . There were no significant differences in baseline or 20-month change in body size or composition , average physical activity , or calcium intake between groups . There were substantially greater gains in lumbar spine ( 41.7 % vs 38.0 % ) and femoral neck ( 24.8 % vs 20.2 % ) BMC in intervention than in control girls ( P high-impact exercise per week implemented over 2 consecutive years within the elementary school curriculum elicited a substantial bone mineral accrual advantage in pubertal girls",
"The effectiveness of an intervention depends on its dose and on moderators of dose , which usually are not studied . The purpose of the study is to determine whether goal setting and theory-based moderators of goal setting had dose relations with increases in goal -related physical activity during a successful workplace intervention . A group-r and omized 12-week intervention that included personal goal setting was implemented in fall 2005 , with a multiracial/ethnic sample of employees at 16 geographically diverse worksites . Here , we examined dose-related variables in the cohort of participants ( N = 664 ) from the 8 worksites r and omized to the intervention . Participants in the intervention exceeded 9000 daily pedometer steps and 300 weekly minutes of moderate-to-vigorous physical activity ( MVPA ) during the last 6 weeks of the study , which approximated or exceeded current public health guidelines . Linear growth modeling indicated that participants who set higher goals and sustained higher levels of self-efficacy , commitment and intention about attaining their goals had greater increases in pedometer steps and MVPA . The relation between change in participants ' satisfaction with current physical activity and increases in physical activity was mediated by increases in self-set goals . The results show a dose relation of increased physical activity with changes in goal setting , satisfaction , self-efficacy , commitment and intention , consistent with goal - setting theory",
"Interventions to promote physical activity are important in preventing children from becoming overweight . Many projects have been developed but only a few showed ( moderate ) effects . JUMP-in is a systematic ally developed primary -school-based intervention that focuses on the use of theory , environmental changes , parental influences and cooperation with multi-level parties in intervention development . The effects of JUMP-in were evaluated with a quasi-experimental pre-test/post-test research design . In total , 510 children from Grade s 4 , 5 and 6 of four intervention schools and two control schools in Amsterdam were followed for an intervention period of one school year . Changes in physical activity as well as in the social cognitive determinants were assessed using self-reports . In addition , a process evaluation has been executed . The results show that JUMP-in was effective in influencing physical activity , especially among children from Grade 6 . Children in the control group decreased their level of physical activity considerably , while activity levels in intervention children from Grade 6 remained stable . The intervention effects could not be explained by changes in the measured social cognitive determinants . In contrast , process information illuminated differences in intervention effects between the participating schools . The results from the JUMP-in study show the importance of intervention design s that focus on a theory-based mix of relevant environmental and social cognitive factors",
"Objective : To assess the impact of an active school model on children ’s physical activity ( PA ) . Design : 16-month cluster r and omised controlled trial . Setting : 10 elementary schools in Greater Vancouver , BC . Participants : 515 children aged 9–11 years . Intervention : Action Schools ! BC ( AS ! BC ) is an active school model that provided schools with training and re sources to increase children ’s PA . Schools implemented AS ! BC with support from either external liaisons ( liaison schools , LS ; four schools ) or internal champions ( champion schools , CS ; three schools ) . Outcomes were compared with usual practice ( UP ) schools ( three schools ) . Main outcome measurements : PA was measured four times during the study using pedometers ( step count , steps/day ) . Results : Boys in the LS group took 1175 more steps per day , on average , than boys in the UP group ( 95 % CI : 97 to 2253 ) . Boys in the CS group also tended to have a higher step count than boys in the UP group ( + 804 steps/day ; 95 % CI : −341 to 1949 ) . There was no difference in girls ’ step counts across groups . Conclusions : The positive effect of the AS ! BC model on boys ’ PA is important in light of the current global trend of decreased PA",
"Background Interventions design ed to increase workplace physical activity may not automatically reduce high volumes of sitting , a behaviour independently linked to chronic diseases such as obesity and type II diabetes . This study compared the impact two different walking strategies had on step counts and reported sitting times . Methods Participants were white-collar university employees ( n = 179 ; age 41.3 ± 10.1 years ; 141 women ) , who volunteered and undertook a st and ardised ten-week intervention at three sites . Pre-intervention step counts ( Yamax SW-200 ) and self-reported sitting times were measured over five consecutive workdays . Using pre-intervention step counts , employees at each site were r and omly allocated to a control group ( n = 60 ; maintain normal behaviour ) , a route-based walking group ( n = 60 ; at least 10 minutes sustained walking each workday ) or an incidental walking group ( n = 59 ; walking in workday tasks ) . Workday step counts and reported sitting times were re-assessed at the beginning , mid- and endpoint of intervention and group mean± SD steps/day and reported sitting times for pre-intervention and intervention measurement points compared using a mixed factorial ANOVA ; paired sample -t-tests were used for follow-up , simple effect analyses . Results A significant interactive effect ( F = 3.5 ; p counts . Daily steps for controls decreased over the intervention period ( -391 steps/day ) and increased for route ( 968 steps/day ; t = 3.9 , p for reported sitting times , but average values did decrease relative to the control ( routes group = 7 minutes/day ; incidental group = 15 minutes/day ) . Reductions were most evident for the incidental group in the first week of intervention , where reported sitting decreased by an average of 21 minutes/day ( t = 1.9 ; p increased physical activity in white-collar employees . Our data suggests that workplace walking , particularly through incidental movement , also has the potential to decrease employee sitting times , but there is a need for on-going research using concurrent and objective measures of sitting , st and ing and walking",
"PURPOSE This study evaluated the effects of a classroom-based physical activity program on children 's in-school physical activity levels and on-task behavior during academic instruction . METHODS Physical activity of 243 students was assessed during school hours . Intervention-group students ( N = 135 ) received a classroom-based program ( i.e. , Energizers ) . The control group ( N = 108 ) did not receive Energizers . On-task behavior during academic instruction time was observed for 62 third- grade ( N = 37 ) and fourth- grade students ( N = 25 ) before and after Energizers activities . An independent groups t-test compared in-school physical activity levels between intervention and control classes . A multiple-baseline across-classrooms design was used to evaluate the effectiveness of the Energizers on on-task behavior . Additionally , a two-way ( time [ pre- vs postobservation ] x period [ baseline vs intervention ] ) repeated- measures analysis of variance compared on-task behavior between observation periods . Magnitudes of mean differences were evaluated with Cohen 's delta ( ES ) . RESULTS Students in the intervention group took significantly ( P in-school steps ( 5587 + /- 1633 ) than control-group students ( 4805 + /- 1543 ) , and the size of this difference was moderate ( ES = 0.49 ) . The intervention was effective in improving on-task behavior ; after the Energizers were systematic ally implemented , on-task behavior systematic ally improved . The improvement in on-task behavior of 8 % between the pre-Energizers and post-Energizers observations was statistically significant ( P on-task behavior by 20 % after Energizers activities . This improvement was statistically significant ( P classroom-based physical activity program was effective for increasing daily in-school physical activity and improving on-task behavior during academic instruction",
"BACKGROUND Physical Activity Across the Curriculum ( PAAC ) was a three-year cluster r and omized controlled trial to promote physical activity and diminish increases in overweight and obesity in elementary school children . METHODS Twenty-four elementary schools were cluster r and omized to the Physical Activity Across the Curriculum intervention or served as control . All children in grade s two and three were followed to grade s four and five . Physical Activity Across the Curriculum promoted 90 min/wk of moderate to vigorous intensity physically active academic lessons delivered by classroom teachers . Body Mass Index was the primary outcome , daily Physical activity and academic achievement were secondary outcomes . RESULTS The three-year change in Body Mass Index for Physical Activity Across the Curriculum was 2.0+/-1.9 and control 1.9+/-1.9 , respectively ( NS ) . However , change in Body Mass Index from baseline to 3 years was significantly influenced by exposure to Physical Activity Across the Curriculum . Schools with > or = 75 min of Physical Activity Across the Curriculum/wk showed significantly less increase in Body Mass Index at 3 years compared to schools that had Physical Activity Across the Curriculum schools had significantly greater changes in daily Physical activity and academic achievement scores . CONCLUSIONS The Physical Activity Across the Curriculum approach may promote daily Physical activity and academic achievement in elementary school children . Additionally , 75 min of Physical Activity Across the Curriculum activities may attenuate increases in Body Mass Index",
"Rationale Recent research has shown that 10 min of moderate intensity exercise reduce smoking withdrawal symptoms and desire to smoke in acutely abstinent smokers . The aim of the current study was to determine whether the reductions are related to participant expectation of these effects . Material s and methods Forty-five sedentary participants who had smoked ten or more cigarettes per day for at least 3 years reported their expectation of the effects of exercise on smoking withdrawal symptoms . Approximately 1 month later , participants were r and omly assigned to one of three groups after 11–15 h of overnight smoking abstinence . Each group read either a positive , negative or neutral statement concerning exercise effects on smoking withdrawal symptoms . They rated their expectation again and then completed 10 min of moderate intensity exercise on a stationary bicycle ergometer . Using st and ardised scales , participants rated smoking withdrawal symptoms and desire to smoke at 10 , 5 and 0 min before exercise , then at 5 and 10 min during exercise and 15 and 20 min post-exercise . Results Expectation of exercise effects on withdrawal were manipulated in the predicted directions . No significant group main effects were found for any symptom . Significant reductions in symptoms and desire to smoke occurred during and after exercise regardless of participant expectation . Conclusions Ten minutes of moderate intensity exercise can lead to reductions in desire to smoke and smoking withdrawal symptoms , which are not due to the participant ’s expectation of exercise effects . These findings support the use of short periods of exercise as an aid to smoking cessation",
"OBJECTIVE To evaluate the effects of an elementary school-based physical education exercise intervention program on bone mineral accrual in prepubertal and early pubertal girls . STUDY DESIGN A total of 14 schools were r and omly assigned to control ( C ) and intervention ( I ) groups . Girls in the I group completed a 10-minute , 3 times per week circuit of varied jumping activities over 7 months . We measured total body , lumbar spine , proximal femur , femoral neck , and trochanteric bone mineral content and areal bone mineral density and estimated femoral neck volumetric bone mineral density at baseline and final measurement in 87 girls in the I group and 90 girls in the C group . Girls were between 8.7 and 11.7 years at baseline . Tanner stage 1 girls were considered prepubertal ; Tanner stages 2 and 3 girls were considered early pubertal . We used analysis of covariance ( adjusting for baseline bone values , change in size , age , and maturity ) to compare 7-month change in bone mineral content , areal bone mineral density , and volumetric bone mineral density between C and I groups within prepubertal and early pubertal girls . RESULTS There was no difference in 7-month change in bone parameters between prepubertal I and C groups . Early pubertal girls in the I group gained 1.5 % to 3.1 % more bone at the femoral neck and lumbar spine than early pubertal girls in the C group ( P exercise interventions to have a positive effect on bone health",
"Objectives : To examine the effects of a simple and inexpensive physical activity intervention on change in bone mass and structure in school aged children . Methods : Fifty one children ( n = 23 boys and 28 girls ; mean age 10.1 years ) participated in “ Bounce at the Bell ” which consisted of 10 counter-movement jumps 3 × per day ( total ∼3 min/day ) . Controls were 71 matched children who followed usual school practice . We assessed dietary calcium , physical activity , physical performance , and anthropometry in September and after 8 months of intervention ( June ) . We measured bone mineral content ( BMC ) and bone area at the lumbar spine , total body , and proximal femur . Proximal femur scans were also analysed for bone geometry and structural strength using the hip structural analysis program . Lean and fat mass ( g ) were also calculated . Results : Groups were similar at baseline and did not differ in weight , height , total body , lumbar spine , proximal femur , or femoral neck BMC . Control children had a greater increase in adjusted total body BMC ( 1.4 % ) . Intervention children gained significantly more BMC at the total proximal femur ( 2 % ) and the intertrochanteric region ( 27 % ) . Change in bone structural parameters did not differ between groups . Conclusions : This novel , easily implemented exercise program , took only a few minutes each day and enhanced bone mass at the weight bearing proximal femur in early pubertal children . A large , r and omised study of boys and girls should be undertaken powered to test the effectiveness of Bounce at the Bell in children at different stages of maturity , and in boys and girls independently",
"UNLABELLED This 16-month r and omized , controlled school-based study compared change in tibial bone strength between 281 boys and girls participating in a daily program of physical activity ( Action Schools ! BC ) and 129 same-sex controls . The simple , pragmatic intervention increased distal tibia bone strength in prepubertal boys ; it had no effect in early pubertal boys or pre or early pubertal girls . INTRODUCTION Numerous school-based exercise interventions have proven effective for enhancing BMC , but none have used pQCT to evaluate the effects of increased loading on bone strength during growth . Thus , our aim was to determine whether a daily program of physical activity , Action Schools ! BC ( AS ! BC ) would improve tibial bone strength in boys and girls who were pre- ( Tanner stage 1 ) or early pubertal ( Tanner stage 2 or 3 ) at baseline . MATERIAL S AND METHODS Ten schools were r and omized to intervention ( INT , 7 schools ) or control ( CON , 3 schools ) . The bone-loading component of AS ! BC included a daily jumping program ( Bounce at the Bell ) plus 15 minutes/day of classroom physical activity in addition to regular physical education . We used pQCT to compare 16-month change in bone strength index ( BSI , mg2/mm4 ) at the distal tibia ( 8 % site ) and polar strength strain index ( SSIp , mm3 ) at the tibial midshaft ( 50 % site ) in 281 boys and girls participating in AS ! BC and 129 same-sex controls . We used a linear mixed effects model to analyze our data . RESULTS Children were 10.2+/-0.6 years at baseline . Intervention boys tended to have a greater increase in BSI ( + 774.6 mg2/mm4 ; 95 % CI : 672.7 , 876.4 ) than CON boys ( + 650.9 mg2/mm4 ; 95 % CI : 496.4 , 805.4 ) , but the difference was only significant in prepubertal boys ( p=0.03 for group x maturity interaction ) . Intervention boys also tended to have a greater increase in SSIp ( + 198.6 mm3 ; 95 % CI : 182.9 , 214.3 ) than CON boys ( + 177.1 mm3 ; 95 % CI : 153.5 , 200.7 ) . Change in BSI and SSIp was similar between CON and INT girls . CONCLUSIONS Our findings suggest that a simple , pragmatic program of daily activity enhances bone strength at the distal tibia in prepubertal boys . The precise exercise prescription needed to elicit a similar response in more mature boys or in girls might be best addressed in a dose-response trial",
"PURPOSE The purpose of this study was twofold : 1 ) to evaluate the effectiveness of a school-based physical activity intervention , Action Schools ! BC ( AS ! BC ) , for maintaining academic performance in a multiethnic group of elementary children , and 2 ) to determine whether boys and girls ' academic performance changed similarly after participation in AS ! BC . METHODS This was a 16-month cluster r and omized controlled trial . Ten schools were r and omized to intervention ( INT ) or usual practice ( UP ) . One INT school administered the wrong final test , and one UP school grade d their own test , so both were excluded . Thus , eight schools ( six INT , two UP ) were included in the final analysis . Children ( 143 boys , 144 girls ) in grade s 4 and 5 were recruited for the study . We used the Canadian Achievement Test ( CAT-3 ) to evaluate academic performance ( TotScore ) . Weekly teacher activity logs determined amounts of physical activity delivered by teachers to students . Physical activity was determined with the Physical Activity Question naire for Children ( PAQ-C ) . Independent t-tests compared descriptive variables between groups and between boys and girls . We used a mixed linear model to evaluate differences in TotScore at follow-up between groups and between girls and boys . RESULTS Physical activity delivered by teachers to children in INT schools was increased by 47 min x wk(-1 ) ( 139 + /- 62 vs 92 + /- 45 , P baseline TotScores than those attending INT schools . Despite this , there was no significant difference in TotScore between groups at follow-up and between boys and girls at baseline and follow-up . CONCLUSION The AS ! BC model is an attractive and feasible intervention to increase physical activity for students while maintaining levels of academic performance",
"This article provides an overview of the development , implementation , and baseline findings from a statewide faith-based physical activity ( PA ) initiative . The 3-year program is training African Method ist Episcopal volunteers across South Carolina to implement programs to increase PA in their congregations . To date , 98 churches have been trained . Interviews done with a r and om sample ( n = 39 ) indicated that 54 % are implementing at least one PA program . The baseline telephone survey ( N = 571 ) estimates that 27.8 % of the population is regularly active , 54.9 % underactive , and 17.3 % sedentary . Baseline rates of regular PA were higher in those who were younger , healthier , and nonsmokers . Challenges to date have included obtaining rosters and implementing a large-scale program with limited re sources . Interest in the program has been strong and supported by church leaders . Current efforts are on training additional churches and working with those already trained to support sustainability",
"OBJECTIVE Whether accumulating short intermittent bouts of light-to-moderate physical activity ( LMPA ) can elicit significant improvements in the fitness of sedentary adults , compared to one longer continuous bout . METHODS Fifty sedentary 35- to 60-year-old adults in Hong Kong were r and omly appointed to one of two gender-balanced intervention programs : Exercise Prescription Model ( EPM ) of 30-minute continuous activity , 3 - 4 days per week , or a Lifestyle group ( LIFE ) of 6-minute activity , 5 times per day , 4 - 5 days per week . Aerobic fitness ( VO(2)max ) , mass , body composition , blood pressure , waist-to-hip ratio , and body mass index ( BMI ) were assessed at baseline ( December 1995 ) and after 8 weeks . RESULTS Nearly half of bouts by the LIFE group were or = 30 min , with no differences in additional energy expenditure between groups ( EPM : 163.0+/-89.6 MET h vs LIFE : 148.2+/-71.6 MET h ) . Both groups significantly improved their VO(2)max , 7.4 % ( ES=0.36 ) and 5.3 % ( ES=0.24 ) for the EPM and Lifestyle groups respectively ( F((1,43))=34.0 , p sedentary adults that is not dissimilar as one continuous bout of similar total duration",
"We examined the effects of a 7-month jumping intervention ( 10 minutes , 3 times per week ) on bone mineral gain in prepubertal Asian and white boys ( 10.3+/-0.6 years , 36.0+/-9.2 kg ) at 14 schools r and omized to control ( n = 60 ) and intervention ( n = 61 ) groups . Intervention and control groups had similar mean baseline and change in height , weight , lean mass and fat mass , baseline areal bone mineral density ( aBMD ; g/cm2 ) , bone mineral content ( BMC ; g ; dual-energy X-ray absorptiometry [ DXA ] , QDR 4500W ) , and similar average physical activity and calcium intakes . Over 7 months , the intervention group gained more total body ( TB ) BMC ( 1.6%,p proximal femur ( PF ) aBMD ( 1 % , p 41 Asian and 50 white boys ( 10.2+/-0.6 years and 31.9+/-4.4 kg ) who were below the 75th percentile ( 19.4 kg/m2 ) of the cohort mean for baseline body mass index ( BMI ) . Boys in the intervention group gained significantly more TB and lumbar spine ( LS ) BMC , PF aBMD , and trochanteric ( TR ) aBMD ( + approximately2 % ) than boys in the control group ( adjusted for baseline weight , final Tanner stage , change in height , and loaded physical activity ) . Bone changes were similar between Asians and whites . Finally , we compared the boys in the control group ( n = 16 ) and the boys in the intervention group ( n = 14 ) whose baseline BMI fell in the highest quartile ( 10.5+/-0.6 years and 49.1+/-8.2 kg ) . Seven-month bone changes ( adjusted as aforementioned ) were similar in the control and intervention groups . In summary , jumping exercise augmented bone mineral accrual at several regions equally in prepubertal Asian and white boys of average or low BMI , and intervention effects on bone mineral were undetectable in high BMI prepubertal boys",
"Physical inactivity and lack of nutritious diets increase children ’s risk of obesity , especially children from low-income and ethnic minority groups . To address this risk , the school-based TAKE 10 ! program was implemented to increase the physical activity and improve the nutrition of K-6th grade students in one public urban school serving a predominantly low-income , Hispanic population . In this study the research ers ( a ) evaluated the program outcomes using the physical activity and nutrition question naires provided with the TAKE 10 ! curriculum material , teacher surveys , observations , and interview data ; ( b ) evaluated the question naires provided with the TAKE 10 ! curriculum material and provided suggestions for modification ; and ( c ) described the experience of a positive partnership among school , university , and community agencies implementing the TAKE 10 ! curriculum . Based on the findings , recommendations are offered for successful physical activity and nutrition health promotion programs for these children",
"BACKGROUND Workplaces are important setting s for interventions to increase physical activity , but effects have been modest . PURPOSE To evaluate the efficacy of Move to Improve , a social-ecologic intervention delivered at the workplace to increase leisure-time physical activity . METHODS A group-r and omized 12-week intervention consisting of organizational action and personal and team goal - setting was implemented in Fall 2005 , with a multi-racial/ethnic sample of 1442 employees at 16 worksites of The Home Depot , Inc. Change in physical activity was analyzed in Fall 2007 using latent growth modeling and latent transition analysis . RESULTS Participants in the intervention had greater increases in moderate and vigorous physical activity and walking compared to participants in a health education control condition . The proportion of participants that met the Healthy People 2010 recommendation for regular participation in either moderate or vigorous physical activity remained near 25 % at control sites during the study but increased to 51 % at intervention sites . During the last 6 weeks of the study , intervention participants exceeded 300 weekly minutes of self-reported moderate-to-vigorous physical activity and 9000 daily pedometer steps . CONCLUSIONS The results support the feasibility and efficacy of the Move to Improve intervention and the role of goal - setting for attaining increased physical activity levels"
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Governments of low- and middle-income countries ( LMICs ) are widely implementing performance-based financing ( PBF ) to improve healthcare services . However , it is unclear whether PBF provides good value for money compared to status quo or other interventions aim ed at strengthening the healthcare system in LMICs . The objective of this systematic review is to identify and synthesize the existing literature that examines whether PBF represents an efficient manner of investing re sources . We considered PBF to be efficient when improved care quality or quantity was achieved with equal or lower costs , or alternatively , when the same quality of care was achieved using less financial re sources . A manual search of the reference lists of two recent systematic review s on economic evaluations of PBF was conducted to identify articles that met our inclusion and exclusion criteria . Subsequently , a search strategy was developed with the help of a librarian . The following data bases and search engines were used : PubMed , EconLit , Google Scholar and Google . Experts on economic evaluations were consulted for validation of the selected studies . A total of seven articles from five LMICs were selected for this review . We found the overall strength of the evidence to be weak . None of the articles were full economic evaluations ; they did not make clear connections between the costs and effects of PBF . Only one study reported using a r and omized controlled trial , but issues with the r and omization procedure were reported . Important alternative interventions to strengthen the capacities of the healthcare system have not been considered . Few studies examined the costs and consequences of PBF in the long term . Important costs and consequences were omitted from the evaluations . Few LMICs are represented in the literature , despite wide implementation . Lastly , most articles had at least one author employed by an organization involved in the implementation of PBF , thereby result ing in potential conflicts of interest . Stronger empirical evidence on whether PBF represents good value for money in LMICs is needed | [
"BACKGROUND Evidence about the best methods with which to accelerate progress towards achieving the Millennium Development Goals is urgently needed . We assessed the effect of performance-based payment of health-care providers ( payment for performance ; P4P ) on use and quality of child and maternal care services in health-care facilities in Rw and a. METHODS 166 facilities were r and omly assigned at the district level either to begin P4P funding between June , 2006 , and October , 2006 ( intervention group ; n=80 ) , or to continue with the traditional input-based funding until 23 months after study baseline ( control group ; n=86 ) . R and omisation was done by coin toss . We surveyed facilities and 2158 households at baseline and after 23 months . The main outcome measures were prenatal care visits and institutional deliveries , quality of prenatal care , and child preventive care visits and immunisation . We isolated the incentive effect from the re source effect by increasing comparison facilities ' input-based budgets by the average P4P payments made to the treatment facilities . We estimated a multivariate regression specification of the difference-in-difference model in which an individual 's outcome is regressed against a dummy variable , indicating whether the facility received P4P that year , a facility-fixed effect , a year indicator , and a series of individual and household characteristics . FINDINGS Our model estimated that facilities in the intervention group had a 23 % increase in the number of institutional deliveries and increases in the number of preventive care visits by children aged 23 months or younger ( 56 % ) and aged between 24 months and 59 months ( 132 % ) . No improvements were seen in the number of women completing four prenatal care visits or of children receiving full immunisation schedules . We also estimate an increase of 0·157 st and ard deviations ( 95 % CI 0·026 - 0·289 ) in prenatal quality as measured by compliance with Rw and an prenatal care clinical practice guidelines . INTERPRETATION The P4P scheme in Rw and a had the greatest effect on those services that had the highest payment rates and needed the least effort from the service provider . P4P financial performance incentives can improve both the use and quality of maternal and child health services , and could be a useful intervention to accelerate progress towards Millennium Development Goals for maternal and child health . FUNDING World Bank 's Bank-Netherl and s Partnership Program and Spanish Impact Evaluation Fund , the British Economic and Social Research Council , Government of Rw and a , and Global Development Network",
"To strengthen Haiti 's primary health care ( PHC ) system , the country first piloted performance-based financing ( PBF ) in 1999 and subsequently exp and ed the approach to most internationally funded non-government organizations . PBF complements support ( training and technical assistance ) . This study evaluates ( a ) the separate impact of PBF and international support on PHC 's service delivery ; ( b ) the combined impact of PBF and technical assistance on PHC 's service delivery ; and ( c ) the costs of PBF implementation in Haiti . To minimize the risk of facilities neglecting potential non-incentivized services , the incentivized indicators were r and omly chosen at the end of each year . We obtained quantities of key services from four departments for 217 health centres ( 15 with PBF and 202 without ) from 2008 through 2010 , computed quarterly growth rates and analysed the results using a difference-in-differences approach by comparing the growth of incentivized and non-incentivized services between PBF and non-PBF facilities . To interpret the statistical analyses , we also interviewed staff in four facilities . Whereas international support added 39 % to base costs of PHC , incentive payments added only 6 % . Support alone increased the quantities of PHC services over 3 years by 35 % ( 2.7%/quarter ) . However , support plus incentives increased these amounts by 87 % over 3 years ( 5.7%/quarter ) compared with facilities with neither input . Incentives alone was associated with a net 39 % increase over this period , and more than doubled the growth of services ( P adverse impacts and , in fact , indicated beneficial impacts on quality . Incentives proved to be a relatively inexpensive , well accepted and very effective complement to support , suggesting that a small amount of money , strategically used , can substantially improve PHC . Haiti 's experience , after more than a decade of use , indicates that incentives are an effective tool to strengthen PHC",
"Performance-based incentives ( PBIs ) aim to counteract weak providers ’ performance in health systems of many developing countries by providing rewards that are directly linked to better health outcomes for mothers and their newborns . Translating funding into better health requires many actions by a large number of people . The actions span from community to the national level . While different forms of PBIs are being implemented in a number of countries to improve health outcomes , there has not been a systematic review of the evidence of their impact on the health of mothers and newborns . This paper analyzes and synthesizes the available evidence from published studies on the impact of supply-side PBIs on the quantity and quality of health services for mothers and newborns . This paper review s evidence from published and grey literature that spans PBI for public-sector facilities , PBI in social insurance reforms , and PBI in NGO contracting . Some initiatives focus on safe deliveries , and others reward a broader package of results that include deliveries . The Evidence Review Team that focused on supply-side incentives for the US Government Evidence Summit on Enhancing Provision and Use of Maternal Health Services through Financial Incentives , review ed published research reports and papers and added studies from additional grey literature that were deemed relevant . After collecting and review ing 17 documents , nine studies were included in this review , three of which used before-after design s ; four included comparison or control groups ; one applied econometric methods to a five-year time series ; and one reported results from a large-scale impact evaluation with r and omly-assigned intervention and control facilities . The available evidence suggests that incentives that reward providers for institutional deliveries result in an increase in the number of institutional deliveries . There is some evidence that the content of antenatal care can improve with PBI . We found no direct evidence on the impact of PBI on neonatal health services or on mortality of mothers and newborns , although intention of the study was not to document impact on mortality . A number of studies describe approaches to rewarding quality as well as increases in the quantities of services provided , although how quality is defined and monitored is not always clear . Because incentives exist in all health systems , considering how to align the incentives of the many health workers and their supervisors so that they focus efforts on achieving health goals for mothers and newborns is critical if the health system is to perform more effectively and efficiently . A wide range of PBI models is being developed and tested , and there is still much to learn about what works best . Future studies should include a larger focus on rewarding quality and measuring its impact . Finally , more qualitative research to better underst and PBI implementation and how various incentive models function in different setting s is needed to help practitioners refine and improve their programmes",
"BACKGROUND Maternity incentive program of Nepal known as Safe Delivery Incentive Program ( SDIP ) was introduced nationwide in 2005 with the intention of increasing utilization of professional care at childbirth . The program provided both childbirth service as well as ' cash ' to women giving birth in a health facility in addition to incentives to health provider for each delivery attended , either at home or the facility . Due to a lack of uniformity in its implementation and administrative delays , the program was reformed and even extended to many not-for-profit health institutions in early 2007 , and implemented as a ' Safer Mother Program ' popularly known as \" Aama-Suraksha-Karyakram \" since January 2009 . METHODS This is a system research with observational and analytical components . Plausibility design is selected to evaluate the performance-based funding ( PBF ) as a system level intervention of maternity care using two instruments : Pay-For-Performance and Conditional-Cash-Transfer . It uses interrupted time-series to control for the natural trend . Research tools used are interviews , the focus group discussion s and literature review . Numerical data are presented in simple graphs . While online r and om number generator was used partly , the purposive sampling was used for qualitative data . RESULTS There is a gross discrepancy in non-targeted service delivery at the tertiary level health facility . Overflooding of maternity cases has hampered gynecological admission and surgical management delaying subspecialty care and junior physicians ' training . With the same number and quality of physical facility and human re source , the additional program has put more strains to service providers and administrators . CONCLUSIONS There should be adequate planning and preparation at all levels of health facilities ; implementing a new program should not adversely affect another existing service delivery system . For the optional implementation , hospital organogram should be revised ; and physical facilities and the low-risk birthing-centers with referral linkages should be exp and ed",
"The Affordable Care Act created the Center for Medicare and Medicaid Innovation ( Innovation Center ) to test innovative payment and service delivery models to reduce program expenditures under Medicare , Medicaid , and the Children ’s Health Insurance Program ( CHIP ) and to enhance the quality of care that Centers for Medicare & Medicaid Services ( CMS ) beneficiaries receive . CMS is testing more than 20 models under this authority that create new incentives for clinicians and organizations that deliver medical care through CMS programs to deliver better care at lower cost . CMS is also supporting a variety of state efforts to create new incentives for these clinicians and organizations through the Medicaid and CHIP programs . All of these models share a common pathway for success : they hinge on getting clinicians and health care organizations to manage the health of population s and to act as good stewards of health care re sources . Data from the first performance year of the Pioneer accountable care organization ( ACO ) model suggest that the Pioneer ACOs generated gross savings of $ 147 million and better quality results for 15 of 15 measures with published national benchmarks . However , for these models to succeed in the long term , “ value-based payment and patient incentives to reward clinicians and health care organizations that offer more real value to patients must spread rapidly to other payers.”1 Long-term success will require clinicians and organizations to make fundamental changes in their day-to-day operations— and , for any individual clinician or organization , making operational changes will be attractive only if the financial incentives are large enough . The financial incentives , in turn , will be large enough only if a critical mass of payers , in addition to CMS , support payment reform.2 For CMS , engaging multiple payers in new payment models is a foundational principle . Medicare , Medicaid , and CHIP constitute only a share of any clinician ’s or health care organization ’s revenue . Therefore , signals from CMS will be strongest if they are aligned with signals from other payers . Efforts to improve quality and reduce cost are more likely to be successful if multiple payers adopt these models . The Innovation Center ’s statute supports this principle . The Affordable Care Act directs the secretary of Health and Human Services to consider , in selecting which models to choose for testing , “ whether the model demonstrates effective linkage with other public sector or private sector payers.”3 The purpose of this Viewpoint is 2-fold : ( 1 ) to describe a framework for underst and ing payment reform that classifies payment models according to how clinicians and health care organizations are paid and creates a common vocabulary for describing the progression of payment reform and ( 2 ) to describe what CMS is doing to lead multipayer participation in payment reform . CMS has a long history of both testing and implementing innovative new payment and delivery models for Medicare and Medicaid . But historically , CMS has not actively sought the participation of other payers in new payment models . If new payment models deployed by CMS have improved quality and reduced cost , other payers have followed — but CMS has not typically actively engaged private payers . One widely studied example of this approach is Medicare ’s implementation of the inpatient prospect i ve payment system in 1983 . Before the introduction of this system , Medicare paid for hospital services based on costs reported by hospitals , subject to limitations in later years . This provided little incentive for hospitals to operate efficiently . In 1983 , the inpatient prospect i ve payment system instituted prospect ively set rates based on diagnosis . In the years following the implementation of this system , Medicare costs for hospital services declined and hospital length of stay decreased.4 At the same time , there was no measurable decline in the quality of hospital care . Observing this success , many commercial payers soon followed and adopted inpatient prospect i ve payment systems of their own . The eTable in the Supplement presents a framework for describing health care payment through the stages of transition from pure fee-for-service to alternative payment methods . This framework classifies payment models according to how clinicians and organizations are paid into 4 categories : category 1—fee-for-service with no link of payment to quality ; category 2—fee-for-service with a link of payment to quality ; category 3—alternative payment models built on fee-for-service architecture ; and category 4— population -based payment . Some Medicare and Medicaid managed care plans still make fee-for-service payments to clinicians and organizations that have no link to quality —these payments would fall into category 1 , not category 4 . In general , 2 features mark the shift across these categories : ( 1 ) clinicians and organizations are increasingly accountable for both quality and total cost of care and ( 2 ) there is a greater focus on population health management as opposed to payment for specific services ( eTable in the Supplement ) . A primary driver of delivery system reform is to move payment systems , both for CMS and for commercial payers , toward alternative payment models and population -based payments and , at the same time , minimize fee-for-service payments that are not linked to quality or value . That is , CMS aims to move an increasingly large share of total payments to clinicians and organizations from fee-for-service with no link to quality to models that reward quality and efficiency in care delivery and to continue to learn how best to incentivize better health outcomes and lower costs . ",
"Review articles published in JAMA summarize various aspects of medical practice and are written by known authorities . An expert ’s opinion about a topic has value , but often more can be learned by that expert ’s assessment of all the pertinent literature . When reading individual research articles , readers could miss subtle features of the studies that are more apparent to an expert clinician research er . Readers benefit from the expert ’s explanation of the validity and applicability of individual studies . When authors summarize the literature , a natural tendency is to select articles supporting their views . To minimize this potential for bias , JAMA editors ask authors to systematic ally review the literature and comment on as much of it as is practical . Extensive literature search es can be difficult to perform , given the complexity of the search process and authors ’ time constraints . It is also unlikely that a content expert will be familiar with the intricacies of more than one data base . Empirical evidence provides a strong rationale for search ing multiple data bases . 1,2 For this reason , collaborating with medical librarians is recommended when writing review articles . A general approach for this collaboration is presented in the Box . Preliminary search es conducted by a librarian can help refine the question and determine its feasibility and scope . These initial screening search es can also inform the development of the review ’s prospect i ve inclusion and exclusion criteria . The choice of data base depends on several factors . Most important is the content ( topic )",
"Pay-for-performance in health care holds promise as a policy lever to improve the quality and efficiency of care . Although the approach has become increasingly popular in developing countries in recent years , most policy design s do not permit the rigorous evaluation of its impact . Thus , evidence of its effect is limited . In collaboration with the government of Ningxia Province , a predominantly rural area in northwest China , we conducted a matched-pair cluster-r and omized experiment between 2009 and 2012 to evaluate the effects of capitation with pay-for-performance on primary care providers ' antibiotic prescribing practice s , health spending , outpatient visit volume , and patient satisfaction . We found that the intervention led to a reduction of approximately 15 percent in antibiotic prescriptions and a small reduction in total spending per visit to village posts-essentially , community health clinics . We found no effect on other outcomes . Our results suggest that capitation with pay-for-performance can improve drug prescribing practice s by reducing overprescribing and inappropriate prescribing . Our study also shows that rigorous evaluations of health system interventions are feasible when conducted in close collaboration with the government"
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BACKGROUND Physiotherapists and clinicians require methods that can be used in everyday practice for measuring proprioception of the trunk in individuals with non-specific low back pain ( NSLBP ) . OBJECTIVE Our objective was to conduct a systematic literature review of methods used for assessment of proprioception of the trunk in individuals with non-specific low back pain . METHOD Data were obtained from MEDLINE , CINAHL , Embase , PEDro and CENTRAL data bases from their inception to December 2011 . Reference lists of the selected review s were h and search ed for other potentially relevant studies . R and omized and nonr and omized controlled studies proprioception of the trunk in individuals with low back pain were selected . Thirty-six studies satisfied the selection criteria and were included in this review . RESULTS Two review ers independently selected the studies , conducted the quality assessment , and extracted data from each study . The Strobe scale was used to evaluate the scientific rigor of each selected study . CONCLUSIONS This systematic review covered all the relevant literature , but none of the included studies offered a valid , reliable and feasible method to assess neuromotor capacity in everyday physiotherapy clinical practice | [
"Study Design . Three factors mixed- design with 1 between-subject and 2 within-subject factors . Objective . To compare the main effects and interactions of postural and cognitive difficulty on quiet stance between subjects with and without nonspecific low back pain ( LBP ) . Summary of Background Data . The interference between postural control and cognitive tasks depends on factors such as sensorimotor/cognitive integrity . Changes in peripheral sensory and muscular systems as well as cognitive processes have been observed in LBP patients . It was hypothesized that the effect of cognitive task on postural performance might be different in subjects with nonspecific LBP as compared with healthy individuals . To the authors ’ knowledge this has not been investigated before . Methods . Postural stability was measured by center of pressure parameters while nonspecific LBP ( n = 22 ) and healthy ( n = 22 ) subjects r and omly performed quiet st and ing task with 3 levels of difficulty ( rigid-surface eyes open , rigid-surface eyes-closed , and foam-surface eyes-closed ) in isolation or concurrently with an easy or difficult digits backward cognitive task . Results . Subjects with nonspecific LBP had less postural sway than healthy subjects , while postural sway decreased with increase in the level of cognitive difficulty . Nonspecific LBP and healthy subjects had larger postural sway at more difficult sensory conditions such as rigid-surface eyes-closed and foam-surface eyes-closed . The response to dual-tasking was not significantly different between the 2 groups . Conclusion . The dual-tasking did not change the postural performance of nonspecific LBP subjects with low level of pain and disability differently compared to healthy subjects",
"This study evaluated the degree to which the disturbance to posture from respiration is compensated for in healthy normals and whether this is different in people with recurrent low back pain ( LBP ) , and to compare the changes when respiratory dem and is increased . Angular displacement of the lumbar spine and hips , and motion of the centre of pressure ( COP ) , were recorded with high resolution and respiratory phase was recorded from ribcage motion . With subjects st and ing in a relaxed posture , recordings were made during quiet breathing , while breathing with increased dead-space to induce hypercapnoea , and while subjects voluntarily increased their respiration to match ribcage expansion that was induced in the hypercapnoea condition . The relationship between respiration and the movement parameters was measured from the coherence between breathing and COP and angular motion at the frequency of respiration , and from averages triggered from the respiratory data . Small angular changes in the lumbopelvic and hip angles were evident at the frequency of respiration in both groups . However , in quiet st and ing , the LBP subjects had a greater displacement of their COP that was associated with respiration than the control subjects . The LBP group had a trend for less hip motion . There were no changes in the movement parameters when respiratory dem and increased involuntarily via hypercapnoea , but when respiration increased voluntarily , the amplitude of motion and the displacement of the COP increased in both groups . The present data suggest that the postural compensation to respiration counteracts at least part of the disturbance to posture caused by respiration and that this compensation may be less effective in people with LBP",
"Study Design . A study of postural control during one‐footed and externally disturbed two‐footed stance among healthy control subjects and patients with chronic low back pain at the beginning of a functional back restoration program and 6 months later at follow‐up examination . Objectives . To study postural control cross‐sectionally among control subjects and patients with low back pain , and to evaluate the effects of functional restoration on the postural control parameters in a follow‐up examination . Summary of Background Data . Deficits of motor skills and coordination have been reported in association with musculoskeletal disorders . It has been found that patients with chronic low back pain have impaired psychomotor control , but the impairment is reversible with successful low back rehabilitation . It is insufficiently known how functional activation and intensive physical training affect postural control . Methods . Sixty‐one healthy volunteers ( 32 men , 29 women ) and altogether 99 patients with low back pain participated in the study . Sixty‐eight patients ( 33 men , 35 women ) had moderate and 31 ( 18 men , 13 women ) had severe low back pain . Postural stability was measured with a force platform . In two‐footed stance , vibration stimulation on calf and back muscles was used to disturb the balance . Center point of force‐velocity ( cm/sec ) , average position shift in anteroposterior direction ( cm ) , and maximal position shift in lateral direction ( cm ) were used as the parameters . Results . Reliability of all tests was acceptable . Center point of force‐velocity was the most sensitive parameter and the one‐footed measurement the most sensitivetest for evaluating postural stability . At the beginning , the patients with severe low back pain had poorer one‐footed postural control compared with the control subjects ( P = 0.0003 ) . The subgroup of patients with moderate low back pain participated in the restoration program . The outcome of the restoration program was considered good if the disability because of low back pain ( Oswestry index ) decreased during the restoration program and poor if the disability increased or did not change . The one‐footed postural stability remained primarily at the same level as the initial results in the control and good outcome groups , but became significantly poorer in the poor outcome group . The difference between poor outcome and control groups was statistically significant ( P = 0.04 ) . Conclusions . Impaired postural stability seems to be one factor in multidimensional symptomatology of patients with chronic low back trouble . Postural stability is easily disturbed in case of impairment in strength , coordination , or effective coupling of muscles in the lumbar and pelvic area . Patients with chronic low back pain seem to experience impairment in these functions , which should be taken into consideration when back rehabilitation programs are planned",
"STUDY DESIGN A cross-sectional study in patients with recurrent/chronic low back trouble and healthy control subjects . OBJECTIVE To evaluate the effect of paraspinal muscle fatigue on the ability to sense a change in lumbar position . SUMMARY OF BACKGROUND DATA Protection against spinal injury requires proper anticipation of events , appropriate sensation of body position , and reasonable muscular responses . Lumbar fatigue is known to delay lumbar muscle responses to sudden loads . It is not known whether the delay is because of failure in the sensation of position , output of the response , or both . METHODS Altogether , 106 subjects ( 57 patients with low back trouble [ 27 men and 30 women ] and 49 healthy control subjects [ 28 men and 21 women ] ) participated in the study . Their ability to sense a change in lumbar position while seated on a special trunk rotation unit was assessed . A motor rotated the seat with an angular velocity of 1 degree per second . The task in the test involved reacting to the perception of lumbar movement ( rotation ) by releasing a button with a finger movement . The test was performed twice , before and immediately after a fatiguing procedure . During the endurance task , the participants performed upper trunk repetitive extensions against a resistance , with a movement amplitude adjusted between 25 degrees flexion and 5 degrees extension , until exhaustion . RESULTS Patients with chronic low back trouble had significantly poorer ability than control subjects on the average to sense a change in lumbar position ( P = 0.007 ) , which was noticed before and after the fatiguing procedure . Lumbar fatigue induced significant impairment in the sensation of position change ( P sense a change in lumbar position . This feature was found in patients and control subjects , but patients with low back trouble had poorer ability to sense a change in lumbar position than control subjects even when they were not fatigued . There seems to be a period after a fatiguing task during which the available information on lumbar position and its changes is inaccurate",
"OBJECTIVE To determine whether body balance is perturbed more in low back pain patients than in healthy subjects , under the concept of posturo-kinetic capacity . DESIGN Comparison of posturographic and respiratory parameters between low back pain and healthy subjects . BACKGROUND It has been demonstrated that respiratory movements constitute a perturbation to posture , compensated by movements of the spine and of the hips , and that low back pain is frequently associated with a loss of back mobility . METHOD Ten low back pain patients and ten healthy subjects performed five posturographic tests under three different respiratory rate conditions : quiet breathing ( spontaneous ) , slow breathing ( 0.1 Hz ) and fast breathing ( 0.5 Hz ) . RESULTS Intergroup comparison showed that the mean displacements of the center of pressure were greater for the low back pain group , especially along the antero-posterior axis , where respiratory perturbation is primarily exerted . Inter-condition comparison showed that in slow and fast breathing relatively to quiet breathing , the mean displacement of the center of pressure along the antero-posterior axis was significantly increased only for the low back pain group . CONCLUSION According to the results , respiration presented a greater disturbing effect on body balance in low back pain subjects . RELEVANCE This study provides information on the causes of the impaired body balance associated with chronic low back pain , which could be used to improve treatment strategy",
"Study Design : A control group study with repeated measures . Objective : To compare trunk repositioning parameters in chronic low back pain ( LBP ) and healthy subjects . Summary and background data : Recent evidence suggests that chronic LBP patients exhibit deficits in trunk proprioception and motor control . Trunk repositioning and the various spatio-temporal parameters related to it can be used to evaluate sensori-motor control and movement strategies . Methods : Fifteen control subjects and 16 chronic LBP subjects participated in this study . Subjects were required to reproduce different trunk position in flexion ( 15 ° , 30 ° and 60 ° ) and extension ( 15 ° ) . In the learning phase preceding each condition , visual feedback was provided . Following these learning trials , subjects were asked to perform ten consecutive trials without any feedback . Movement time , movement time variability and peak velocity were obtained and a temporal symmetry ratio was calculated . Peak angular position variability and absolute error in peak angular position were also calculated to evaluate spatial accuracy . Results : Two subgroups of LBP patients were identified . One subgroup of LBP subjects demonstrated longer movement time and smaller peak velocities and symmetry ratios than normal subjects . No group difference was observed for peak angular position variability and absolute error in peak angular position . Conclusion : Chronic LBP patients , when given a sufficient learning period , were able to reproduce trunk position with a spatial accuracy similar to control subjects . Some LBP subjects , however , showed modifications of movement time , peak velocity and acceleration parameters . We propose that the presence of persistent chronic pain could induce an alteration or an adaptation in the motor responses of chronic LBP subjects",
"Insight into the mechanisms of altered postural control in persons with low back pain ( LBP ) could lead to better interventions for patients with LBP . This study investigated ( 1 ) whether persons with recurrent LBP have an altered body inclination , and ( 2 ) whether anticipation of postural instability further alters body inclination . Thirty-three young healthy individuals and 56 young persons with recurrent LBP participated in this study . The upright st and ing posture was evaluated by means of two piezo-resistive electrogoniometers and a force platform for the conditions as follows : ( 1 ) quiet stance with and without vision , and ( 2 ) in anticipation of postural instability due to a ballistic arm movement or ankle muscle vibration . No differences in body inclination were observed when visual information was available between the two groups ( P>0.05 ) . However , significant more forward inclination was seen in the persons with recurrent LBP when vision was occluded ( + 7.4 % ) and in anticipation of postural instability ( + 19 % ) ( P young persons with recurrent LBP have an altered body inclination that might be caused by anticipation of postural instability . The adopted forward inclined posture may potentially be a factor in the recurrence of LBP",
"Study Design . A clinical trial comparing a back pain group with a pain‐free group . Objectives . To investigate whether proprioceptive deficits existed in a group of individuals reporting low back pain . Summary of Background Data . Little work has so far been conducted on the measurement of proprioception in the spine . Those studies that have been carried out , however , have failed to identify proprioceptive deficits in individuals with back pain . Previous work on peripheral joints has revealed that proprioception is affected with muscular or joint injury or degeneration . Methods . Forty individuals took part in the study , 20 with back pain and 20 with no pain . Participants were required to reproduce a predetermined target position , in st and ing and four‐point kneeling , 10 times in 30 seconds . A computer screen was used to provide visual feedback on position . A mean deviation from the target position was obtained for each individual . A measurement of left elbow position sense was conducted in five individuals from each group to establish differences in short‐term motor memory between the groups . Results . There were no differences between the subject groups in terms of short‐term motor memory ( P > 0.05 ) . A two‐way analysis of variance between subject groups and position to identify differences in accuracy ( deviation from the target ) found that there were differences between subject groups in either position ( P in accuracy between the positions used ( P > 0.05 ) . Conclusions . Differences in proprioception do exist between individuals with back pain and those free from back pain . Further research needs to be undertaken on proprioceptive exercise programs and their effect on back pain",
"BACKGROUND Low back pain is associated with abnormal movement strategies due to changes in neuromuscular control . A plausible contributing factor to low back pain is poor control of trunk muscles , thus underst and ing motor control alterations in this population can guide rehabilitation . Quantification of postural responses following support surface translations is one way to examine motor control impairments in people with low back pain . METHODS Twenty-four healthy subjects [ mean 33 ( SD 11 ) years ] who had no low back pain and 26 subjects [ mean 39 ( SD 13 ) years ] with chronic , recurrent low back pain were instructed to st and with feet placed on separate force plates , which were mounted on a moveable platform . The platform was translated unexpectedly in one of 12 directions for a total of 72 trials . For both the sagittal and frontal planes , the net center of pressure displacement was derived and the total body center of mass was calculated by combining kinematic and anthropometric data . FINDINGS For sagittal plane responses , subjects with low back pain had reduced and delayed sagittal plane center of pressure responses ( P center of mass responses were larger in magnitude ( P=0.03 ) yet similarly delayed in onset ( P=0.04 ) for the low back pain group . Frontal plane responses did not differ between groups . INTERPRETATION Subjects with low back pain have altered automatic postural coordination , both in terms of magnitude and timing of responses , indicating alterations in neuromuscular control",
"Recurrence quantification analysis ( RQA ) , a nonlinear method of postural analysis , was used to explore the effects of dual-tasking on postural performance in people with nonspecific low back pain ( LBP ) compared with healthy participants . Postural performance was quantified by RQA % recurrence , % determinism , entropy and trend . People with nonspecific LBP ( n=22 ) and unimpaired individuals ( n=22 ) r and omly performed quiet st and ing tasks with three levels of difficulty ( rigid-surface eyes open , rigid-surface eyes closed and foam-surface eyes closed ) . These tasks were performed in isolation or concurrently with an easy or difficult cognitive task . Increasing postural difficulty was associated with higher % determinism , higher entropy and lower trend in anteroposterior ( AP ) and mediolateral ( ML ) directions in people with LBP and healthy participants . All RQA variables in the ML direction decreased as cognitive conditions became more difficult . Significant interactions between group and cognitive difficulty were shown for % recurrence , % determinism and trend in the AP direction . While healthy participants decreased % recurrence and trend by increasing the level of cognitive difficulty , the LBP patients did not . This preliminary study suggests that LBP may be one factor that modulates the posture-cognition interaction"
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QUESTION Does resistance training , either alone or as an adjunct to aerobic training , improve cardiac function , exercise capacity and quality of life in people with chronic heart failure ? DESIGN Systematic review with meta- analysis of r and omised trials . PARTICIPANTS Adults with stable chronic heart failure . INTERVENTION Progressive resistance exercise training , alone or as an adjunct to aerobic training . OUTCOME MEASURES Cardiac function , exercise capacity and quality of life . RESULTS 241 participants from eight trials performed 2 to 6 months of moderate-intensity resistance training ( 50 - 75 % of 1RM ) . Most programs consisted of 5 to 6 exercises for large limb and trunk muscles with two sets of 8 to 12 repetitions , three times a week . Resistance training significantly increased 6-minute walk distance ( WMD 52 m , 95 % CI 19 to 85 ) but not peak oxygen consumption ( WMD 1.4 ml/kg/min , 95 % CI -0.3 to 3.1 ) . When used as an adjunct to aerobic training , resistance training did not significantly alter left ventricular ejection fraction ( WMD -0.5 % , 95 % CI -4.3 to 3.3 ) , peak oxygen consumption ( WMD -0.7 ml/kg/min , 95 % CI -2.3 to 1.0 ) , or Minnesota Living with Heart Failure Question naire scores ( WMD -0.9 , 95 % CI -5.4 to 3.7 ) , compared with aerobic training alone . CONCLUSION Resistance training increased 6-minute walk distance compared to no training , but had no other benefits on cardiac function , exercise capacity , or quality of life if used alone or as an adjunct to aerobic training in people with chronic heart failure . However , further high quality , large scale , r and omised trials are needed | [
"Background Exercise training has now become established practice in patients with chronic heart failure . Women are often under-represented in intervention studies compared to men . For this reason it was our aim to conduct a combined endurance and muscle strength training program to evaluate its effect on clinical performance data and health-related psychosocial factors in women and men . Methods One hundred and sixteen women , mean age 69 ± 9 years , body mass index ( BMI ) 25.8 ± 4.9 , and 169 men , mean age 66 ± 9 years , BMI 26.6 ± 3.6 underwent combined endurance/resistance training . The training program lasted 29 ± 7 days and comprised bicycle ergometer training , a 6-min walk test as a training unit and muscle strength training for the lower and upper extremities . Results Differences between women and men were found in clinical parameters . In particular , statistically significant differences were revealed between the women and men with regard to cardiopulmonary performance . Quality of life was significantly improved on discharge with regard to both physical and mental health , whereas anxiety and depression showed no significant alteration . Conclusion A specialized in-hospital program for women and men combining endurance/resistance training and education is feasible . But our program revealed a very low level of cardiopulmonary performance in women . Women need to be encouraged and motivated to participate in such programs",
"Exercise is now considered an important component of management in chronic heart failure ( CHF ) , but little is known about central hemodynamic changes that occur during different exercise modalities in these patients . Seventeen patients ( ejection fraction 25 + /- 2 % ) undertook brachial artery and right heart catheterization and oxygen consumption assessment at rest , during submaximal and peak cycling ( Cyc ) , and during submaximal upper and lower limb resistance exercise . Cardiac output ( CO ) increased relative to baseline during peak Cyc ( P upper or lower limb exercise . Heart rate ( HR ) was lowest during upper limb exercise and progressively increased during lower limb exercise , submaximal Cyc , and peak Cyc , with significant differences between each of these ( P stroke volume ( SV ) decreased during submaximal Cyc and lower limb exercise and was lower during peak and submaximal Cyc and lower limb exercise than during upper limb exercise ( P CHF patients are dependent on increases in HR to increase CO during exercise when SV may decline . Resistance exercise , performed at appropriate intensity , induces a similar hemodynamic burden to aerobic exercise in patients with CHF",
"BACKGROUND We aim ed to determine the role of skeletal muscle mitochondrial ATP production rate ( MAPR ) in relation to exercise tolerance after resistance training ( RT ) in chronic heart failure ( CHF ) . METHODS AND RESULTS Thirteen CHF patients ( New York Heart Association functional class 2.3 + /- 0.5 ; Left ventricular ejection fraction 26 + /- 8 % ; age 70 + /- 8 years ) underwent testing for peak total body oxygen consumption ( VO(2peak ) ) , and resting vastus lateralis muscle biopsy . Patients were then r and omly allocated to 11 weeks of RT ( n = 7 ) , or continuance of usual care ( C ; n = 6 ) , after which testing was repeated . Muscle sample s were analyzed for MAPR , metabolic enzyme activity , and capillary density . VO(2peak ) and MAPR in the presence of the pyruvate and malate ( P+M ) substrate combination , representing carbohydrate metabolism , increased in RT ( P MAPR and the change in peak total body oxygen consumption ( VO(2peak ) ) over the study ( r = 0.875 ; P CHF patients and can be favorably altered by muscle strengthening exercise",
"BACKGROUND Resistance training increases the skeletal muscle strength and functional ability of chronic heart failure patients . However , there is limited data regarding the effect of resistance training on the hemodynamic responses and peak oxygen consumption ( peak VO(2 ) ) of chronic heart failure patients treated with beta-blocker . This study examined the effect of resistance training on hemodynamics , peak aerobic capacity , muscle strength and quality of life of chronic heart failure patients on beta-blockers medication . METHODS Fifteen men diagnosed with chronic heart failure were matched to either a resistance training program or non-training control group . At baseline and after 8 weeks of resistance training patients performed both Balke incremental and maximal strength tests and completed quality of life question naires . RESULTS The resistance training group demonstrated a significant increase of walking time and peak VO(2 ) by 11.7 % ( p=0.002 ) and approximately 19 % ( p Peak VO(2 ) was significantly correlated with both walking time ( r=0.54 , p=0.038 ) and change in total weight lifted ( r=0.55 , p=0.034 ) . Quality of life significantly increased by 87 % ( p=0.030 ) . The improvement in quality of life was correlated with post training peak VO(2 ) ( r=0.58 , p=0.025 ) and total weight lifted during the post maximal strength test ( r=-0.52 , p=0.047 ) . CONCLUSIONS The benefits from resistance training for chronic heart failure patients on beta-blocker medication included an increased aerobic and exercise capacity , skeletal muscle strength and most importantly , an improvement in the quality of life , which is the main goal of cardiac rehabilitation programs . Furthermore , with appropriate supervision , it is recommended that resistance exercise be added to the exercise rehabilitation program of these patients when possible",
"CONTEXT Guidelines recommend that exercise training be considered for medically stable out patients with heart failure . Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes . OBJECTIVE To test the efficacy and safety of exercise training among patients with heart failure . DESIGN , SETTING , AND PATIENTS Multicenter , r and omized controlled trial of 2331 medically stable out patients with heart failure and reduced ejection fraction . Participants in Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ( HF-ACTION ) were r and omized from April 2003 through February 2007 at 82 centers within the United States , Canada , and France ; median follow-up was 30 months . INTERVENTIONS Usual care plus aerobic exercise training , consisting of 36 supervised sessions followed by home-based training , or usual care alone . MAIN OUTCOME MEASURES Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality , cardiovascular mortality or cardiovascular hospitalization , and cardiovascular mortality or heart failure hospitalization . RESULTS The median age was 59 years , 28 % were women , and 37 % had New York Heart Association class III or IV symptoms . Heart failure etiology was ischemic in 51 % , and median left ventricular ejection fraction was 25 % . Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12 . A total of 759 patients ( 65 % ) in the exercise training group died or were hospitalized compared with 796 patients ( 68 % ) in the usual care group ( hazard ratio [ HR ] , 0.93 [ 95 % confidence interval { CI } , 0.84 - 1.02 ] ; P = .13 ) . There were nonsignificant reductions in the exercise training group for mortality ( 189 patients [ 16 % ] in the exercise training group vs 198 patients [ 17 % ] in the usual care group ; HR , 0.96 [ 95 % CI , 0.79 - 1.17 ] ; P = .70 ) , cardiovascular mortality or cardiovascular hospitalization ( 632 [ 55 % ] in the exercise training group vs 677 [ 58 % ] in the usual care group ; HR , 0.92 [ 95 % CI , 0.83 - 1.03 ] ; P = .14 ) , and cardiovascular mortality or heart failure hospitalization ( 344 [ 30 % ] in the exercise training group vs 393 [ 34 % ] in the usual care group ; HR , 0.87 [ 95 % CI , 0.75 - 1.00 ] ; P = .06 ) . In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics , the HRs were 0.89 ( 95 % CI , 0.81 - 0.99 ; P = .03 ) for all-cause mortality or hospitalization , 0.91 ( 95 % CI , 0.82 - 1.01 ; P = .09 ) for cardiovascular mortality or cardiovascular hospitalization , and 0.85 ( 95 % CI , 0.74 - 0.99 ; P = .03 ) for cardiovascular mortality or heart failure hospitalization . Other adverse events were similar between the groups . CONCLUSIONS In the protocol -specified primary analysis , exercise training result ed in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points . After adjustment for highly prognostic predictors of the primary end point , exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00047437",
"Objective : To determine the short- and long-term effects of an intensive , concentrated rehabilitation programme in patients with chronic heart failure . Design : R and omized controlled trial , with one-month and six-year evaluations . Setting : Residential rehabilitation centre in Switzerl and . Subjects : Fifty patients with chronic heart failure , r and omized to exercise or control groups . Interventions : A rehabilitation programme lasting one month , including educational sessions , a low-fat diet , and 2 hours of individually prescribed exercise daily . Main measures : Exercise test responses , health outcomes and physical activity patterns . Results : Peak Vo2 increased 21.4 % in the exercise group during the rehabilitation programme ( P , peak Vo2 was only slightly higher than that at baseline in the trained group ( 7 % , NS ) , while peak Vo2 among controls was unchanged . During long-term follow-up , 9 and 12 patients died in the exercise and control groups , respectively ( P = 0.63 ) . At six years , physical activity patterns tended to be higher in the exercise group ; the mean energy expenditure values over the last year were 2704 ± 1970 and 2085 ± 1522 kcal/week during recreational activities for the exercise and control groups , respectively . However , both groups were more active compared to energy expenditure prior to their cardiac event ( P residential rehabilitation programme , patients with chronic heart failure had slightly better outcomes than control subjects , maintained exercise capacity and engaged in activities that exceed the minimal amount recommended by guidelines for cardiovascular health",
"INTRODUCTION Resistance training ( RT ) has been shown to improve chronic heart failure ( CHF ) patients ' functional ability and quality of life . Despite these benefits RT has not always been recommend as a form of exercise principally because of a concern for acceleration of the left ventricular ( LV ) remodeling process . This study investigated the effects of 8 weeks RT on the LV structure and function of patients with CHF . METHOD Fifteen men who suffered from CHF were divided into either a RT program or non-training control group . Before and after 8 weeks of training patients underwent resting echocardiography to assess their end-diastolic and end-systolic dimensions ( EDD and ESD , respectively ) , ejection fraction ( EF ) , fractional shortening ( FS ) and stroke volume ( SV ) . RESULTS A repeated measured ANOVA showed that 8 weeks of RT had no significant effect on the LV measurements ( group x time , p>0.05 ) . Post training comparison , however , revealed that the EF and FS of the training group was significantly higher than in the control group ( 40.9+/-10.5 % vs. 30.3+/-4.6 % , p=0.029 and 25.0+/-7.0 % vs. 17.4+/-3.1 % , p=0.020 respectively ) . CONCLUSION RT is a suitable method of training for CHF patients since it does not cause a reduction of LV contractility function or enhance myocardial deterioration as measured by EF and FS",
"PURPOSE The aim of this study was to compare the effects of endurance training alone ( ET ) with combined endurance and strength training ( CT ) on hemodynamic and strength parameters in patients with congestive heart failure ( CHF ) . METHODS Twenty male patients with CHF were r and omized into one of two training regimens consisting of endurance training or a combination of endurance and resistance training . Group ET had 40-min interval cycle ergometer endurance training three times per week . Group CT combined endurance and strength training with the same interval endurance training for 20 min , followed by 20 min of strength training . Left ventricular function was assessed at baseline and after 40 training sessions by echocardiography and radionuclide ventriculography . Work capacity was measured with cardiopulmonary exercise test ( CPX ) and lactate determination . Strength was measured with an isokinetic dynamometer . RESULTS After 40 sessions , the ET group improved functional class , work capacity , peak torque , and muscular endurance . However , peak O2 remained unchanged . Left ventricular ejection fraction ( LVEF ) and fractional shortening ( FS ) decreased , whereas left ventricular end-diastolic diameter ( LVED ) increased . The CT group improved NYHA score , working capacity , peak O2 , and peak lactate ; peak torque and muscular endurance , LVEF , and FS increased , whereas LVED decreased . Compared with ET , CT was significantly ( P improving LV function . CONCLUSION Combined endurance/strength training was superior to endurance training alone concerning improvement of LV function , peak VO2 , and strength parameters . It appears that for stable CHF patients , a greater benefit can be derived from this training modality",
"This study examined the effect of a novel circuit weight training ( CWT ) program on cardiorespiratory fitness , muscular strength , and body composition in 13 patients with chronic heart failure ( CHF ) , using a prospect i ve r and omized crossover protocol . Peak exercise oxygen uptake ( VO(2 peak ) ) increased after the 8-wk CWT program ( 19 . 5 + /- 1.2 vs. 22.0 + /- 1.5 ml . kg(-1 ) . min(-1 ) , P Submaximal exercise heart rate was lower after training at 60 and 80 W ( 121 + /- 3 vs. 134 + /- 5 beats/min , P rate pressure product , whereas ventilatory threshold increased , from 52 + /- 3 to 58 + /- 3 % of VO(2 peak ) ( P CWT also increased maximal isotonic voluntary contractile strength for seven different muscle groups , from 392 to 462 kg ( P = 0.001 ) . CWT , an exercise prescription specifically targeting peripheral abnormalities in CHF , improves functional capacity and muscular strength in these patients",
"We measured skeletal muscle mass and peak oxygen consumption ( VO2 ) in 13 cachectic heart failure patients , 14 noncachectic patients , and in 52 healthy controls to examine skeletal muscle atrophy and its relation to low peak VO2 in heart failure patients . Our results show that skeletal muscle atrophy is associated with prior weight loss and is related to low peak VO2 in heart failure patients",
"Chronic heart failure ( CHF ) is characterized by a skeletal muscle myopathy not optimally addressed by current treatment paradigms or aerobic exercise . Sixteen older women with CHF were compared with 80 age-matched peers without CHF and r and omized to progressive resistance training or control stretching exercises for 10 wk . Women with CHF had significantly lower muscle strength ( P aerobic capacity to women without CHF . Exercise training was well tolerated and result ed in no changes in resting cardiac indexes in CHF patients . Strength improved by an average of 43.4 + /- 8.8 % in resistance trainers vs. -1.7 + /- 2.8 % in controls ( P = 0.001 ) , muscle endurance by 299 + /- 66 % vs. 1 + /- 3 % ( P = 0.001 ) , and 6-min walk distance by 49 + /- 14 m ( 13 % ) vs. -3 + /- 19 m ( -3 % ) ( P = 0.03 ) . Increases in type I fiber area ( 9.5 + /- 16 % ) and citrate synthase activity ( 35 + /- 21 % ) in skeletal muscle were independently predictive of improved 6-min walk distance ( r2 = 0.78 ; P = 0.0024 ) . High-intensity progressive resistance training improves impaired skeletal muscle characteristics and overall exercise performance in older women with CHF . These gains are largely explained by skeletal muscle and not resting cardiac adaptations",
"Objective : To examined the effects of different training modalities on exercise capacity ( Vo 2peak ) , systolic function , muscular strength and endurance and quality of life in heart failure patients . Design : R and omized controlled trial . Setting : Cardiac rehabilitation centre in Canada . Subjects : Forty-two individuals with heart failure ( 62 ± 12 years ; New York Heart Association ( NYHA ) classes I — III ) . Interventions : Aerobic training ( n = 14 ) , combined aerobic and resistance training ( n = 15 ) or usual care ( n = 13 ) three times per week for 12 weeks . Main measures : ( 1 ) Vo 2peak measured by symptom-limited grade d exercise test on cycle ergometer ; ( 2 ) systolic function assessed by two-dimensional echocardiography ; ( 3 ) muscular strength and muscular endurance measured by one-repetition maximum procedure ; and ( 4 ) quality of life assessed by question naires . Results : In the intention-to-treat analysis , neither aerobic nor combined aerobic and resistance training significantly improved Vo2peak , systolic function or quality of life compared with usual care . However , combined aerobic and resistance training significantly improved upper extremity strength ( 40.7 (14.0)—48.5 ( 16.0 ) kg , P ( 5.7 (2.7)—11.6 ( 7.6 ) reps , P , Vo2peak increased in the aerobic group ( 16.9 (6.0)—19.0 ( 6.8 ) , P= 0.026 ) and tended to increase in the combined training group ( 15.9 (5.0)—17.6 ( 5.6 ) , P= 0.058 ) compared with usual care . Quality of life was improved in the aerobic group only . Conclusions : Both aerobic and combined aerobic and resistance training are effective interventions to improve Vo2peak in compliant heart failure patients . Combined training may be more effective in improving muscle strength and endurance",
"To increase muscle mass and strength in patients with chronic congestive heart failure ( CHF ) , there is a need for implementing resistance exercises in exercise training programs . This study sought to assess the safety of rhythmic strength exercise with respect to left ventricular function in 9 patients with stable CHF , compared with 6 stable coronary patients with mild left ventricular dysfunction ( control group ) . With use of right-sided catheterization , changes in left ventricular function were assessed during double leg press exercise at loads of 60 % and 80 % of maximum voluntary contraction . The exercise sessions lasted 14 minutes each , divided into work and recovery phases of 60/120 seconds . In CHF , during exercise at a 60 % load , there was a significant increase in heart rate ( mean + /- SEM 90 + /- 4 beats/min ; p mean arterial blood pressure ( 95 + /- 3 mm Hg ; p diastolic pulmonary artery pressure ( 20.2 + /- 2.7 mm Hg ; p cardiac index ( 3 + /- 0.3 L/m2/min ; p leg press exercise at an 80 % load , there was a significant decrease in systemic vascular resistance ( 1,086 + /- 80 dynes x s x cm(-5 ) ; p cardiac index ( 3.4 + /- 0.1 ; p left ventricular stroke work index ( 75 + /- 5 g x m/m2 ; p enhanced left ventricular function . Compared with controls , in CHF the magnitude of changes in hemodynamic parameters during exercise , demonstrated at a 60 % load , was significantly smaller ( systemic vascular resistance : [ mean ] 1,613 -- > 1000 vs 1472 -- > 1,247 dynes x s x cm(-5 ) ; cardiac index : 2.4 -- > 3 vs 2.8 -- > 4.4 L/m2/min , and stroke work index : 60 -- > 69 vs 114 -- > 155 g x m/m2 ; p contractile function of the left ventricle in CHF . This study demonstrates stability of left ventricular function during resistance exercise in well-compensated CHF patients with optimal drug therapy , as well as the appropriateness of the chosen mode and intensity applied as these factors relate to cardiovascular stress . This conclusion can not be extrapolated to patients with less well-compensated heart failure , or to more protracted resistance training",
"BACKGROUND Resistance exercise training was applied to patients with chronic heart failure ( CHF ) on the basis that it may partly reverse deficiencies in skeletal muscle strength and endurance , aerobic power ( VO(2peak ) ) , heart rate variability ( HRV ) , and forearm blood flow ( FBF ) that are all putative factors in the syndrome . METHODS AND RESULTS Thirty-nine CHF patients ( New York Heart Association Functional Class=2.3+/-0.5 ; left ventricular ejection fraction 28%+/-7 % ; age 65+/-11 years ; 33:6 male : female ) underwent 2 identical series of tests , 1 week apart , for strength and endurance of the knee and elbow extensors and flexors , VO(2peak ) , HRV , FBF at rest , and FBF activated by forearm exercise or limb ischemia . Patients were then r and omized to 3 months of resistance training ( EX , n=19 ) , consisting of mainly isokinetic ( hydraulic ) ergometry , interspersed with rest intervals , or continuance with usual care ( CON , n=20 ) , after which they underwent repeat endpoint testing . Combining all 4 movement patterns , strength increased for EX by 21+/-30 % ( mean+/-SD , P endurance improved 21+/-21 % ( P CON remained almost unchanged ( strength P VO(2peak ) improved in EX by 11+/-15 % ( P ratio of low-frequency to high-frequency spectral power fell after resistance training in EX by 44+/-53 % ( P FBF increased at rest by 20+/-32 % ( P limb ischemia ( 26+/-45 % , P EX , but not in CON ( P resistance exercise training in CHF patients produced favorable changes to skeletal muscle strength and endurance , VO(2peak ) , FBF , and HRV",
"PURPOSE An open , r and omized , controlled study was design ed to study the effects of exclusive strength training ( ST ) in patients with severe chronic heart failure ( CHF ) in comparison with conventional endurance ( ET ) and combined ET-ST training ( CT ) . The hypothesis was that ST would at least be equal to ET or CT , because peripheral muscle atrophy and weakness play a key role in exercise limitation in CHF patients . METHODS Three groups of 15 patients underwent ST , ET , or CT during 40 sessions , three times a week , for 45 min . Fifteen patients served as control group . Before and after intervention , left ventricular ejection fraction ( LVEF ) , peak oxygen consumption ( VO2peak ) , peak workload , thigh muscle volume , knee extensor strength , endurance , and quality of life ( QoL ) were assessed . RESULTS All measured parameters improved significantly in the three training groups , except for knee extensor strength in ET . Training outcome was superior in all three training groups compared with the control group , but statistical significance was only reached for VO2peak and peak workload , thigh muscle volume , and knee extensor endurance . In contrast , knee extensor strength , LVEF , and QoL did not reach statistical significance . None of the training modalities proved to be superior to any other , although small differences between the three groups were observed . CONCLUSION Independently of the training modality , intensive exercise training is efficient in increasing cardiac function , exercise capacity , peripheral muscle function , and QoL in CHF patients",
"BACKGROUND The effect that supervised or unsupervised exercise training has on aerobic capacity ( peak oxygen consumption [ VO2peak ] ) , muscle strength and quality of life in older women with heart failure remains unknown . OBJECTIVE To examine the effect of six months ( three months supervised followed by three months unsupervised ) of aerobic training ( AT ) or combined aerobic and strength training ( CAST ) on VO2peak , muscle strength and quality of life in older women with heart failure . METHODS Twenty older women ( mean age + /- SD , 72+/-8 years ) with clinical ly stable heart failure were r and omly assigned to AT ( n=10 ) or CAST ( n=10 ) . Supervised AT was performed two days per week at 60 % to 70 % heart rate reserve , whereas unsupervised training was performed two days per week at a rate of perceived exertion of 12 to 14 on the Borg scale . The CAST group also performed one to two sets of low-to-moderate intensity strength training two days per week . RESULTS Supervised AT or CAST result ed in an increase in VO2peak ( 12 % ; P leg press strength ( 13 % ; P . Vertical row strength was greater ( + 23 % ; P supervised CAST and remained unchanged after supervised or unsupervised AT . Supervised or unsupervised exercise training was not associated with a significant change in quality of life . CONCLUSIONS Supervised AT or CAST are effective modes of exercise to improve VO2peak and muscle strength in older women with heart failure . However , the improvements in VO2peak and muscle strength are not maintained with unsupervised exercise training",
"BACKGROUND Beneficial training outcomes have been reported in patients with chronic heart failure ( CHF ) following leg exercise training . However , data from more comprehensive training programs are limited . The aim of this study was to test the hypothesis that exercise training applying the concept of comprehensive local muscle training can improve aerobic and functional working capacity as well as quality of life in patients with CHF . METHODS Twenty-four men and women [ age 63+/-9 years ( mean+/-S.D. ) ] with stable , moderate chronic heart failure ( left ventricular ejection fraction 30+/-10 % ) , were investigated in a r and omized controlled study with a training group of 16 patients and a control group of 8 patients . The training was performed as an aerobic resistance training by activating all the main muscle groups , one at a time . The patients exercised for 1 h , three times per week for 8 weeks . RESULTS Patient groups did not differ at baseline . Peak oxygen uptake ( 8 % , P distance walked in a 6-min walking test ( 11 % , P health-related quality of life ( P plasma norepinephrine levels at rest ( 32 % , P peak oxygen uptake ( P quality of life scores ( P comprehensive physical training activating a minor muscle mass at a time markedly improves exercise capacity and quality of life and reduces catecholamine levels , it can be recommended for the rehabilitation of patients with CHF under supervision of a physical therapist",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"The aim of the study was to evaluate , in a controlled setting , the effects of a 5-month dynamic peripheral training programme in patients with clinical signs of congestive heart failure with special reference to their anaerobic threshold , muscle function , heart rate variability and quality of life . Twenty-four r and omized patients with clinical signs of heart failure in NYHA II-III entered the study . Training result ed in a significant ( p = 0.01 ) change in the anaerobic threshold , the patients ' ability to lift weights ( p = 0.01 ) and performance of heel-lift ( p = 0.01 ) . The heart rate recorded during the training exercises decreased significantly ( p = 0.04 ) . There were no significant differences in peak oxygen uptake , isokinetic and isometric strength , HRV and quality of life except for three items in the control group . The results of this study indicate that peripheral training is beneficial for patients with clinical signs of congestive heart failure",
"The purpose of this study was to determine the efficacy of resistance exercise in reversing skeletal muscle myopathy in heart transplant recipients . Myopathy , engendered by both heart failure and immunosuppression with glucocorticoids , is a post-transplant complication . The sequelae of myopathic disease includes fiber-type shifts and deficits in aerobic metabolic capability . We r and omly assigned patients to either 6 months of resistance exercise ( training group ; n = 8) or a control ( control group ; n = 7 ) group . Exercise was initiated at 2 months after transplant . Biopsy of the right vastus lateralis was performed before and after the 6-month intervention . Myosin heavy chain ( MHC ) composition was assessed using sodium dodecyl sulfate-polyacrylamide gel electrophoresis . Biochemical assays were performed to determine citrate synthase , 3-hydroxyacyl-CoA-dehydrogenase , and lactate dehydrogenase activity . There were no group differences ( p > or=0.05 ) in MHC composition and enzymatic reserve at baseline . Improvements in the training group for citrate cynthase ( + 40 % ) , 3-hydroxyacyl-CoA-dehydrogenase ( + 10 % ) , and lactate dehydrogenase activity ( + 48 % ) were significantly greater ( p Oxidative type 1 MHC isoform concentration increased significantly in the training group ( + 73 % , p Glycolytic type 2x MHC isoform increased significantly ( 17 % ; p training elicits myofibrillar shifts from less oxidative type II fibers to more oxidative fatigue-resistant type I fibers in heart transplant recipients . Resistance exercise initiated early in the post-transplant period is efficacious in changing skeletal muscle phenotype through increases in enzymatic reserve and shifts in fiber morphology",
"AIMS To determine the prevalence , incidence rate , lifetime risk and prognosis of heart failure . METHODS AND RESULTS The Rotterdam Study is a prospect i ve population -based cohort study in 7983 participants aged > or = 55 . Heart failure was defined according to criteria of the European Society of Cardiology . Prevalence was higher in men and increased with age from 0.9 % in subjects aged 55 - 64 to 17.4 % in those aged > or = 85 . Incidence rate of heart failure was 14.4/1000 person-years ( 95 % CI 13.4 - 15.5 ) and was higher in men ( 17.6/1000 man-years , 95 % CI 15.8 - 19.5 ) than in women ( 12.5/1000 woman-years , 95 % CI 11.3 - 13.8 ) . Incidence rate increased with age from 1.4/1000 person-years in those aged 55 - 59 to 47.4/1000 person-years in those aged > or = 90 . Lifetime risk was 33 % for men and 29 % for women at the age of 55 . Survival after incident heart failure was 86 % at 30 days , 63 % at 1 year , 51 % at 2 years and 35 % at 5 years of follow-up . CONCLUSION Prevalence and incidence rates of heart failure are high . In individuals aged 55 , almost 1 in 3 will develop heart failure during their remaining lifespan . Heart failure continues to be a fatal disease , with only 35 % surviving 5 years after the first diagnosis",
"Skeletal muscle adaptations to high intensity knee extensor strength and /or endurance training in patients with chronic heart failure were investigated . Eleven patients with chronic heart failure were r and omized into two groups and exercised the m. quadriceps femoris 3 days/week for 8 weeks . After training , the maximal exercise intensity tolerated on the ergometer cycle was raised from 99 ( 32 ) to 114 ( 40 ) watts ( W , P Peak dynamic knee extensor work rate showed the greatest increase after endurance training ( 40 % , P Maximal dynamic and isometric strength were elevated by 40 - 45 % ( P strength training . The cross-sectional area of m. quadriceps femoris was increased in the strength-trained legs ( 9 % , P capillary per fibre ratio of m. vastus lateralis was raised by 47 and 58 % in the endurance-trained legs ( P oxidative enzyme activity in m. vastus lateralis was significantly raised above 50 % after endurance training , whereas glycolytic enzyme activity was unaltered . The peripheral skeletal musculature in patients with chronic heart failure adapts fairly quickly to high intensity knee extensor training . This results in a marked rise in local , and a small rise in total work capacity , indicating maintained plasticity of skeletal muscle in chronic heart failure patients",
"CONTEXT Findings from previous studies of the effects of exercise training on patient-reported health status have been inconsistent . OBJECTIVE To test the effects of exercise training on health status among patients with heart failure . DESIGN , SETTING , AND PATIENTS Multicenter , r and omized controlled trial among 2331 medically stable out patients with heart failure with left ventricular ejection fraction of 35 % or less . Patients were r and omized from April 2003 through February 2007 . INTERVENTIONS Usual care plus aerobic exercise training ( n = 1172 ) , consisting of 36 supervised sessions followed by home-based training , vs usual care alone ( n = 1159 ) . R and omization was stratified by heart failure etiology , which was a covariate in all models . MAIN OUTCOME MEASURES Kansas City Cardiomyopathy Question naire ( KCCQ ) overall summary scale and key subscales at baseline , every 3 months for 12 months , and annually thereafter for up to 4 years . The KCCQ is scored from 0 to 100 with higher scores corresponding to better health status . Treatment group effects were estimated using linear mixed models according to the intention-to-treat principle . RESULTS Median follow-up was 2.5 years . At 3 months , usual care plus exercise training led to greater improvement in the KCCQ overall summary score ( mean , 5.21 ; 95 % confidence interval , 4.42 to 6.00 ) compared with usual care alone ( 3.28 ; 95 % confidence interval , 2.48 to 4.09 ) . The additional 1.93-point increase ( 95 % confidence interval , 0.84 to 3.01 ) in the exercise training group was statistically significant ( P KCCQ score for either group ( P = .85 for the difference between slopes ) , result ing in a sustained , greater improvement overall for the exercise group ( P KCCQ subscales , and no subgroup interactions were detected . CONCLUSIONS Exercise training conferred modest but statistically significant improvements in self-reported health status compared with usual care without training . Improvements occurred early and persisted over time . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00047437"
] | 41162a54-06ff-11f0-808a-c43d1ab1c353 |
Background Despite over 2 decades of research , the ability to prevent work-related low back pain ( LBP ) and disability remains elusive . Recent research suggests that interventions that are focused at the workplace and incorporate the principals of participatory ergonomics and return-to-work ( RTW ) coordination can improve RTW and reduce disability following a work-related back injury . Workplace interventions or programs to improve RTW are difficult to design and implement given the various individuals and environments involved , each with their own unique circumstances . Intervention mapping provides a framework for design ing and implementing complex interventions or programs . The objective of this study is to design a best evidence RTW program for occupational LBP tailored to the Ontario setting using an intervention mapping approach . Methods We used a qualitative synthesis based on the intervention mapping methodology . Best evidence from systematic review s , practice guidelines and key articles on the prognosis and management of LBP and improving RTW was combined with theoretical models for managing LBP and changing behaviour . This was then systematic ally operationalized into a RTW program using consensus among experts and stakeholders . The RTW Program was further refined following feedback from nine focus groups with various stakeholders . Results A detailed five step RTW program was developed . The key features of the program include ; having trained personnel coordinate the RTW process , identifying and ranking barriers and solutions to RTW from the perspective of all important stakeholders , mediating practical solutions at the workplace and , empowering the injured worker in RTW decision-making . Conclusion Intervention mapping provided a useful framework to develop a comprehensive RTW program tailored to the Ontario setting | [
"This study evaluated a two-year multidisciplinary early intervention pilot programme for back-injured nurses employed at a large teaching hospital , using a pre- versus post-programme analysis . The purpose was to ascertain whether this programme could reduce the incidence , morbidity , time lost and cost due to back injuries in the 250 nurses employed on ten targeted high-risk wards . Injuries in the remaining 1395 nurses employed on the other 45 wards were monitored concurrently for comparison . The programme consisted of prompt assessment , treatment and rehabilitation through modified work . Evaluative data were gathered by one research nurse on st and ardized forms at the time of injury , weekly until return to work , and at a six-month follow-up . Time lost and cost data for up to one-year post-injury were derived from workers ' compensation statements . Compared to the two years prior to introduction of the programme , the rates of back injuries and lost-time back injuries decreased by 23 % and 43 % , respectively , on the targeted wards , while these increased on the control wards . Combined expenditure was 32 % lower per injury and 34 % lower per lost-time injury for those in the targeted group who consented to take part in the programme compared to their counterparts on the control wards , as the increased assessment and treatment costs per case attributable to the programme were more than offset by the savings in lower compensation ( wage loss ) costs . This programme thus reduced the incidence and time lost due to back injuries and was cost-beneficial ",
"This study reports the evaluation of an intervention design edto reinforcetobacco abstinence amongelementary schoolchildren in a school transition period . This intervention was developed according to the principles of Intervention Mapping . A total of 765 grade 5 students ( ages 10 - 12 ) was recruited in 32 elementary schools . A quasi-experimental longitudinal design was used to evaluate the outcomes . Results observed 2 and 8 months postintervention are reported here . It is shown that although the behavior remained largely unchanged by the intervention , some of its determinants were modified . Behavioral intention , behavioral and normative beliefs , perceived self-efficacy , and role beliefs were changed at one or both postintervention measures . An interesting feature of these results relates to the fact that the most positive outcomes were seen among at-risk children . Discussion considers the advisability to develop , implement , and evaluate evidence -based interventions targeting the psychosocial factors underlying maintenance of tobacco smoking abstinence in elementary school",
"& NA ; A cognitive – behavioral return‐to‐work focused program was evaluated in a r and omized controlled design , and the effects were compared between two groups of women with musculoskeletal pain . One group of patients ( n=36 ) had a history of long‐term sick leave ( > 12 months ) at the start of the program and the other ( n=36 ) had a history of short‐term sick leave ( 2–6 months ) . The outpatient treatment program , conducted by a psychologist , included 12 sessions with the primary aim to help the patients return‐to‐work . The treatment first included teaching of coping strategies such as applied relaxation , stress management , grade d activity training and pacing . Thereafter the patients were taught how to manage difficulties at their return‐to‐work and how to generalize coping strategies to different risk factors at their work places . The control condition received treatment‐as‐usual . The results showed that the cognitive – behavioral return‐to‐work program was more effective than the treatment‐as‐usual control condition in reducing the number of days on sick leave for patients on short‐term sick leave , but not for patients on long‐term sick leave . The treatment program also helped the patients on short‐term sick leave to increase their ability to control and decrease pain and to increase their general activity level compared to the control condition . These results underscore the need for an early return‐to‐work focused rehabilitation to prevent long‐term sick leave and disability",
"Study Design . Modifying effects in multivariate analyses of a r and omized controlled trial . Objectives . To identify prognostic factors for the effect of a brief intervention ( “ modifiers ” ) at a spine clinic on return to work in patients with subacute low back pain . Summary of Background Data . A previous study of a brief intervention showed significant reduction of sick leave , compared with usual primary healthcare treatment . R and omized controlled trials give data only on the group as an average . Identifying prognostic factors that interact with the treatment ( “ modifiers ” ) may identify specific groups requiring this or other types of treatment . Methods . A total of 457 patients who had been sick-listed 8 to 12 weeks for low back pain were r and omized into an intervention group ( spine clinic with medical examination , information , reassurance , encouragement to engage in physical activity , n = 237 ) , and a control group ( primary health care , n = 220 ) . All subjects filled out question naires . Logistic regression and tests for interaction were used to identify prognostic factors and modifiers for return to work in the two groups , at 3 and 12 months of follow-up . Results . At 3 months of follow-up , the strongest modifying effect on return to work was the perception of constant back strain when working and beliefs about reduced ability to work . At 12 months , gastrointestinal complaints were the strongest modifier for the effect of the intervention . Conclusion . The spine clinic intervention seems to have a main effect on work absenteeism via interacting with the concerns of being unable to work",
"This paper describes a participatory ergonomics program aim ed at early return to regular work of workers suffering from subacute occupational back pain and assesses the perceptions of the participants on the implementation of ergonomic solutions in the workplace . The participatory ergonomics program was used in the rehabilitation of workers suffering from subacute back pain for more than 6 weeks , a program that was associated with an increased rate of return to work . The perceptions of the participatory ergonomics participants were assessed 6 months after completion of the ergonomic intervention through a question naire sent to employer representatives , union representatives and injured workers of participating workplaces . About half of the ergonomic solutions were implemented according to the perception of the participants , with a substantial agreement between respondents",
"Study Design . Population ‐based r and omized clinical trial . Objectives . To develop and test a model of management of subacute back pain , to prevent prolonged disability . Summary of Background Data . The present management of back pain seems inadequate , and development of innovative models has been urged . Methods . A model for the treatment of subacute work‐related back pain has been developed and evaluated in a population ‐based r and omized clinical trial . Workers ( n = 130 ) from eligible workplaces in the Sherbrooke area ( N = 31 ) , who had been absent from work for more than 4 weeks for back pain , were r and omized , based on their workplace , in one of four treatment groups : usual care , clinical intervention , occupational intervention , and full intervention ( a combination of the last two ) . The duration of absence from regular work and from any work was evaluated using survival analysis . Functional status and pain were compared at study entry and after 1 year of follow‐up . Results . The full intervention group returned to regular work 2.41 times faster than the usual care intervention group ( 95 % confidence interval 1.19‐4.89 ; P = 0.01 ) . The specific effect of the occupational intervention accounted for the most important part of this result , with a rate ratio of return to regular work of 1.91 ( 95 % confidence interval = 1.18‐3.10 ; P demonstrated either a statistically significant reduction or a trend toward reduction in the three intervention groups , compared with the trend in the usual care intervention group . Conclusions . Close association of occupational intervention with clinical care is of primary importance in impeding progression toward chronicity of low back pain",
"Low back pain patients ( n=142 ) on sick leave for at least 8 weeks were given a multi-modal cognitive behavioural treatment program ( MMCBT ) that lasted for 4 weeks . Before treatment , all patients were tested with a comprehensive test battery . The outcome at 12-month follow-up was predictable from the pretest , but only when combining medical and psychological data . Patients who returned to work ( Returners , 50 % ) in the MMCBT group were characterised by less pain , more psychological strength , were evaluated by the physiotherapist as having a good prognosis for return to work , and were less educated . Patients who did not return to work ( Non-returners ) in the MMCBT group felt tense and unfit , felt hopelessness concerning the future , were less physically active , thought their complaints would worsen if they continued working , and reported fewer difficulties driving a car . Returners to work ( 58 % ) in the r and omised control group ( n=81 ) , who received ordinary physical therapy , were characterised by high levels of energy , less subjective health complaints , less exhaustion for a condition test , and did not work in positions giving a constant load on the back . There was no significant differences between number of patients who had returned to work in the MMCBT and the control group . Non-returners in the control group lacked energy , trained less regularly , worked in occupations that gave an almost constant load on the back , and did not expect to be back to work in the course of a couple of weeks . It seems to be important to develop further diagnostic tools to identify those who might benefit from extensive or specific treatments . Copyright 1998 European Federation of Chapters of the International Association for the Study of Pain",
"Study Design . A 5-year follow-up of a r and omized , controlled trial . Objective . To evaluate the long-term health and economic consequences of a cognitive behavioral intervention . Summary of Background Data . Linton and And ersson ( Spine 2000;25:2825–31 ) provide 1 of only a few studies on the preventive effects of a cognitive behavioral intervention . The present study is a 5-year follow-up . Methods . In the original study , 213 participants were r and omized to the cognitive-behavioral group intervention or to usual care plus information on self-care ( information comparison group ) . Of participants , 97 % completed a follow-up question naire 5 years after the intervention , and supplemental records were obtained from the National Insurance Authority . Results . The cognitive behavioral group had significantly less pain , was more active , enjoyed better quality of life , and had better general health relative to the information comparison group . There was no difference on health care use . The risk of long-term sick leave was 3 times higher in the information comparison group . The cognitive behavioral group had significantly less lost productivity costs and a lower total cost/y/person ( 16,514 Swedish kronor ) compared to the information comparison group ( 45,990 Swedish kronor ) . Conclusions . A cognitive-behavioral group intervention produces long-term health and economic benefits . Usual medical care might be improved considerably by implementing these psychologic methods",
"The aim of this study was to determine whether grade d activity restored occupational function in industrial blue-collar workers who were sick-listed for 8 weeks because of subacute , nonspecific , mechanical low back pain ( LBP ) . Patients with LBP , who had been examined by an orthopedic surgeon and a social worker , were r and omly assigned to either an activity group ( n = 51 ) or a control group ( n = 52 ) . Patients with defined orthopedic , medical , or psychiatric diagnoses were excluded before r and omization . The grade d activity program consisted of four parts : ( 1 ) measurements of functional capacity ; ( 2 ) a work-place visit ; ( 3 ) back school education ; and ( 4 ) an individual , submaximal , gradually increased exercise program , with an operant-conditioning behavioral approach , based on the results of the tests and the dem and s of the patient 's work . Records of the amount of sick leave taken over a 3-year period ( ie , the 1-year periods before , during , and after intervention ) were obtained from each patient 's Social Insurance Office . The patients in the activity group returned to work significantly earlier than did the patients in the control group . The median number of physical therapist appointments before return to work was 5 , and the average number of appointments was 10.7 ( SD = 12.3 ) . The average duration of sick leave attributable to LBP during the second follow-up year was 12.1 weeks ( SD = 18.4 ) in the activity group and 19.6 weeks ( SD = 20.7 ) in the control group . Four patients in the control group and 1 patient in the activity group received permanent disability pensions . The grade d activity program made the patients occupationally functional again , as measured by return to work and significantly reduced long-term sick leave",
"STUDY DESIGN Cluster r and omized controlled trial . OBJECTIVE To evaluate the effectiveness of two strategies to improve the use of active sick leave ( ASL ) for patients with low back pain . SUMMARY OF BACKGROUND DATA ASL is a public sickness benefit scheme offered to promote early return to modified work for temporarily disabled workers . It was poorly used , and the authors design ed two community interventions to strengthen the implementation of ASL based on the results of a study of barriers to use among back pain patients , employers , general practitioners ( GPs ) , and local National Insurance Administration staff . METHODS Sixty-five municipalities in three counties in Norway , r and omly assigned to a passive intervention , a proactive intervention , or a control group . The interventions were targeted at patients on sick leave for low back pain for more than 16 days ( n = 6176 ) , their GPs , employers , and local insurance officers . The passive intervention included reminders about ASL on the sick leave form that GPs must complete , a st and ard agreement to facilitate ASL , targeted information , and a desktop summary for GPs of clinical practice guidelines for low back pain , emphasizing the importance of advice to stay active . The proactive intervention included these elements plus a re source person to facilitate the use of ASL and a continuing education workshop for GPs . The main outcome measure reported here is the proportion of eligible patients that used ASL . RESULTS ASL was used significantly more in the proactive intervention municipalities ( 17.7 % ) compared with the passive intervention and control municipalities ( 11.5 % , P = 0.018 ) . CONCLUSIONS A passive intervention that addressed identified barriers to the use of ASL did not increase its use . Although modest , a proactive intervention did increase its use . The main impact of the intervention was through direct contact and motivating telephone calls to patients . To the extent that GPs ' practice was changed , it was either patient mediated or by patients bypassing their GP",
"Background : Information on prognostic factors for duration of sick leave due to low-back pain ( LBP ) is growing . In this prospect i ve cohort study prognostic factors for duration of sick leave and course of disability were identified in a very early stage of sick leave due to LBP in an occupational health care setting . Methods : A total of 615 workers calling in sick from work due to LBP at an occupational health service ( OHS ) of one institution completed a question naire . Duration of follow-up was 26 weeks . Prognostic factors were identified by means of Cox regression analysis and multiple linear regression analysis , and explained variance was calculated . Results : Median time to first return to work ( RTW ) was 5 days ( Inter Quartile Range ( IQR ) = 2–12 ) . Median time to lasting return to work ( LRTW ) was 6 days ( IQR = 3–13 ) . The final model for delayed RTW included self-reported expected duration of sick-leave , treatment by GP or specialist , care-seeking , diminished mobility , and the interaction between care-seeking and diminished mobility . The final model for LRTW included : self-reported expected duration of sick-leave , treatment by GP or specialist , care-seeking , the interaction between the self-reported expected duration of sick-leave and seeking care at OHS , complaints due to job stress , diminished mobility , and the interactions between expected duration of more then 10 days and seeking OP care and diminished mobility . Median total days on sick leave ( TDSL ) was 6 days ( IQR = 3–13 days ) . The final model for TDSL included : age , expected duration of sick leave , treatment by GP or medical specialist , seeking OP care , complaints due to physical load , and diminished mobility . Explained variance ( R2 ) of these models ranged from 30 to 35 % . Conclusions : Poor prognosis for duration of sick leave can be identified by means of a simple question naire administered on the first day of sick leave . Workers at high risk for longer duration of sick leave ( all outcomes ) expected to stay off work longer , were already being treated by a MD , sought OP care , and had diminished mobility . In case of delayed LRTW workers reported job stress as a possible cause of sick leave . Interactions were found in both RTW and LRTW between care-seeking and diminished mobility and in LRTW between expected duration of sick leave and seeking OP care . Older age increased TDSL with borderline significance",
"Context Low back pain causes frequent disability and lost productive time . Contribution This r and omized trial compared a behavioral-oriented grade d activity program with usual care in 134 Dutch airline company workers who had missed work because of persistent low back pain . Grade d activity consisted of biweekly 1-hour exercise sessions with physiotherapists who emphasized operant-conditioning principles . Over 6 months of follow-up , participants in the grade d activity program missed 58 days of work , while participants receiving usual care missed 87 days . Implication s A behavioral-oriented grade d activity program returned participants with low back pain to work more often than did usual care . The Editors Nonspecific low back pain is an uncomfortable medical condition that causes frequent disability and absence from work . Most episodes of low back pain resolve fairly quickly and cause only short periods of absence from work . However , some workers with low back pain miss work for several days to weeks and are at risk for more permanent disability ( 1 ) . To reduce the individual and socioeconomic burden related to this absenteeism , we need effective intervention strategies in occupational health care setting s that promote safe and rapid return to work . One promising and often-advocated intervention strategy for workers with prolonged nonspecific low back pain is active rehabilitation that is directed toward return to normal activity and work ( 2 ) . Examples are grade d activity interventions that include physical exercise , application of operant-conditioning behavioral principals , and promotion of improved functioning and safe return to work even if pain persists ( 3 - 6 ) . In a r and omized , controlled trial , Lindstrm and colleagues ( 3 , 4 ) found that a grade d activity intervention reduced absence from work more than did traditional care in Swedish workers employed in the automobile industry . We investigate , in a second r and omized , controlled trial , whether absence from work because of low back pain is reduced more with grade d activity intervention than with traditional care in an occupational health care setting in the Netherl and s. Methods Study Design and Sample The study was a single-blind , r and omized , controlled trial in an occupational health services center ( KLM Health , Safety and Environment ) at Schiphol Airport , Amsterdam , the Netherl and s. The center provides occupational health services for all employees of a major Dutch airline ( KLM Royal Dutch Airlines ) . The source sample ( n = 20 000 ) consisted of workers who were employed in the following organizational units of the airline : baggage and aircraft turnaround services , passenger services , engineering and maintenance , cargo , and cabin and cockpit . Workers who were listed as absent from work because of low back pain were invited for a consultation with the occupational physician . Those who were thought to be eligible for inclusion were referred to the research assistant , who judged whether they met the inclusion criteria : full or partial absence from work because of nonspecific low back pain and low back pain symptoms with a minimum duration of 4 weeks in succession . The exclusion criteria were low back pain with radiation below the knee with signs of nerve-root compression ( 7 ) ; cardiovascular contraindications for physical activity , as checked according to the Physical Activities Readiness Question naire ( 8 , 9 ) ; any conflict between worker and employer with legal involvement ; or pregnancy . Workers who met the inclusion criteria were informed of the purpose and procedures of the study and were enrolled after giving informed consent . The Medical Ethical Committee of the VU University Medical Center , Amsterdam , the Netherl and s , approved the study . Treatment Allocation The participants were assigned to grade d activity or usual care on the basis of block r and omization , after prestratification for the organizational unit in the workplace from which they were recruited ( the 5 organizational units listed earlier ) and for the severity of pain symptoms ( scored on a scale of 0 to 10 ; severity scores were points ) . This result ed in a total of 10 strata . R and omized , permuted blocks of 4 allocations were generated for each stratum through a computer-generated r and om-sequence table . Opaque , sequentially numbered , sealed envelopes were prepared for each stratum by a research er who was not involved in enrolling the participants or assigning them to their groups . The envelopes contained a sheet of paper that indicated 1 of the 2 interventions . Participants learned their group assignments after a research assistant completed the baseline measurements and delivered the sealed envelopes . Blinding The research assistants who collected the data were blinded to the treatment allocation . All participants were repeatedly asked not to reveal any information about their treatment allocation . The participants and treatment providers were not blinded to treatment allocation . Interventions In the Dutch occupational health care system , occupational physicians guide disabled workers who are absent from work through their disability period . These occupational physicians are employed by occupational health services that are paid for by the companies . The occupational physicians adhere to back pain management strategies that consist of advising workers on ergonomics , prevention , and return-to-work schedules and advising and communicating with other stakeholders ( such as health care providers and representatives of the workplace ) . Disabled workers who participated in the present study were assigned to either grade d activity or usual care within the context of the Dutch occupational health care setting . Grade d Activity The intervention group received the usual guidance from the occupational physician about work-related problems and barriers to return to work as well as the grade d activity intervention supervised by a physiotherapist . Three physiotherapists who worked in a private practice at Schiphol Airport provided the treatment according to the grade d activity protocol . Two of those physiotherapists were also trained as manual therapists , and 1 was also a human movement scientist . Before the study , the physiotherapists had been specifically trained to treat patients with low back pain according to behavioral principles . A research physiotherapist who was experienced in treating patients with chronic pain in rehabilitation centers instructed the physiotherapists in three 2-hour sessions and practice d patienttherapist interactions with them through role-play . Before the study , the physiotherapists treated several patients according to the grade d activity protocol to gain more experience . The physiotherapists made audiotapes of the intervention sessions before and during the study period . The contents of these audiotapes were assessed and discussed with the research physiotherapist in 3 additional meetings . Furthermore , the physiotherapists summarized the treatment after each session , and research ers used these summaries to review the sessions . The same physiotherapist treated participants each time , except for temporary st and -in sessions that were supervised by colleagues because of holidays or other reasons . Specific therapists were not systematic ally selected to treat specific participants ; selection was based on pragmatic reasons , such as the time available in the work schedules of the physiotherapists or the days of treatment preferred by the participants . Table 1 presents the concept and content of the grade d activity intervention . The intervention consisted of 1-hour exercise sessions that participants attended twice per week until they returned completely to regular work or until the maximum therapy duration of 3 months was reached . At the start of the intervention , the physiotherapist inquired about the participant 's medical history and completed a brief physical examination consisting of flexion , extension , and lateroflexion of the lumbar spine and a brief screening for nerve-root pain ( 10 ) . The purpose of the physical examination was to confirm the diagnosis of benign , nonspecific low back pain and to reduce participants ' fears about any presumed underlying disease . The participants were reassured that despite the annoying pain , nothing was seriously wrong with their backs . Subsequently , the physiotherapist and participant decided on a set of general exercises and individually tailored exercises . Both types of exercises had to be performed during each session . The general exercises were aerobic exercises , such as cycling or rowing , and strengthening exercises for large muscle groups , and most were carried out in a gym while using exercise equipment . The strengthening exercises were a floor abdominal sit-up exercise , a dynamic back extension exercise , a leg-press exercise , a latissimus pull-down exercise , and st and ing up from a low chair . Participants in the grade d activity group had to perform not only these general exercises but also individually tailored exercises , which imitated physical tasks at work or difficult and painful activities of daily living . For example , a participant who reported back problems while lifting and moving suitcases from a luggage wagon into an airplane might be given an exercise to practice lifting and moving a suitcase with a certain number of repetitions . During the first 3 sessions , the maximal performance ( for example , the maximum number of repetitions ) was assessed for each exercise separately , and the average score for each exercise over the 3 sessions was used as a baseline value for specifying a gradually progressive exercise scheme . Subsequently , the participant was asked to propose a date for full return to regular work , which would consequently be the end point of the physical exercise program . Before returning to full regular work , participants could return to work with modified hours and duties . Advised by the physiotherapist , the participant",
"Study Design . A controlled r and omized clinical trial was performed . Objective . To investigate the effect of a light mobilization program on the duration of sick leave for patients with subacute low back pain . Summary of Background Data . Early intervention with information , diagnostics , and light mobilization may be a cost-effective method for returning patients quickly to normal activity . In this experiment , patients were referred to a low back pain clinic and given this simple and systematic program as an outpatient treatment . Methods . In this study , 457 patients sick-listed 8 to 12 weeks for low back pain , as recorded by the National Insurance Offices , were r and omized into two groups : an intervention group ( n = 237 ) and a control group ( n = 220 ) . The intervention group was examined at a spine clinic and given information and advice to stay active . The control group was not examined at the clinic , but was treated with conventional primary health care . Results . At 12-month follow-up assessment , 68.4 % in the intervention group had returned to full-duty work , as compared with 56.4 % in the control group . Conclusions . Early intervention with examination , information , and recommendations to stay active showed significant effects in reducing sick leave for patients with low back pain",
"Objectives Given the individual and economic burden of chronic work disability in low back pain patients , there is a need for effective preventive interventions . The aim of the present study was to investigate whether problem-solving therapy had a supplemental value when added to behavioral grade d activity , regarding days of sick leave and work status . Design R and omized controlled trial . Patients and Setting Employees who were recently on sick leave as a result of nonspecific low back pain were referred to the rehabilitation center by general practitioner , occupational physician , or rehabilitation physician . Forty-five employees had been r and omly assigned to the experimental treatment condition that included behavioral grade d activity and problem-solving therapy ( GAPS ) , and 39 employees had been r and omly assigned to behavioral grade d activity and group education ( GAGE ) . Outcome Measures Days of sick leave and work status . Data were retrieved from occupational health services . Results Data analyses showed that employees in the GAPS group had significantly fewer days of sick leave in the second half-year after the intervention . Moreover , work status was more favorable for employees in this condition , in that more employees had a 100 % return-to-work and fewer patients ended up receiving disability pensions one year after the intervention . Sensitivity analyses confirmed these results . Conclusions The addition of problem-solving therapy to behavioral grade d activity had supplemental value in employees with nonspecific low back pain",
"Background : Tools for early identification of workers with back pain who are at high risk of adverse occupational outcome would help concentrate clinical attention on the patients who need it most , while helping reduce unnecessary interventions ( and costs ) among the others . This study was conducted to develop and vali date clinical rules to predict the 2-year work disability status of people consulting for nonspecific back pain in primary care setting s. Methods : This was a 2-year prospect i ve cohort study conducted in 7 primary care setting s in the Quebec City area . The study enrolled 1007 workers ( participation , 68.4 % of potential participants expected to be eligible ) aged 18–64 years who consulted for nonspecific back pain associated with at least 1 day 's absence from work . The majority ( 86 % ) completed 5 telephone interviews documenting a large array of variables . Clinical information was abstract ed from the medical files . The outcome measure was “ return to work in good health ” at 2 years , a variable that combined patients ' occupational status , functional limitations and recurrences of work absence . Predictive models of 2-year outcome were developed with a recursive partitioning approach on a 40 % r and om sample of our study subjects , then vali date d on the rest . Results : The best predictive model included 7 baseline variables ( patient 's recovery expectations , radiating pain , previous back surgery , pain intensity , frequent change of position because of back pain , irritability and bad temper , and difficulty sleeping ) and was particularly efficient at identifying patients with no adverse occupational outcome ( negative predictive value 78%– 94 % ) . Interpretation : A clinical prediction rule accurately identified a large proportion of workers with back pain consulting in a primary care setting who were at a low risk of an adverse occupational outcome",
"In an attempt to prevent acute low-back pain from becoming a chronic disability problem , an earlier study developed a statistical algorithm which accurately identified those acute low-back pain patients who were at high risk for developing such chronicity . The major goal of the present study was to evaluate the clinical effectiveness of employing an early intervention program with these high-risk patients in order to prevent the development of chronic disability at a 1-year follow-up . Approximately 700 acute low-back pain patients were screened for their high-risk versus low-risk status . On the basis of this screening , high-risk patients were then r and omly assigned to one of two groups : a functional restoration early intervention group ( n = 22 ) , or a nonintervention group ( n = 48 ) . A group of low-risk subjects ( n = 54 ) who did not receive any early intervention was also evaluated . All these subjects were prospect ively tracked at 3-month intervals starting from the date of their initial evaluation , culminating in a 12-month follow-up . During these follow-up evaluations , pain disability and socioeconomic outcomes ( such as return-to-work and healthcare utilization ) were assessed . Results clearly indicated that the high-risk subjects who received early intervention displayed statistically significant fewer indices of chronic pain disability on a wide range of work , healthcare utilization , medication use , and self-report pain variables , relative to the high-risk subjects who do not receive such early intervention . In addition , the high-risk nonintervention group displayed significantly more symptoms of chronic pain disability on these variables relative to the initially low-risk subjects . Cost-comparison savings data were also evaluated . These data revealed that there were greater cost savings associated with the early intervention group versus the no early intervention group . The overall results of this study clearly demonstrate the treatment- and cost-effectiveness of an early intervention program for acute low-back pain patients",
"Background : Low back pain is a common medical and social problem associated with disability and absence from work . Knowledge on effective return to work ( RTW ) interventions is scarce . Objective : To determine the effectiveness of grade d activity as part of a multistage RTW programme . Design : R and omised controlled trial . Setting : Occupational healthcare . Subjects : 112 workers absent from work for more than eight weeks due to low back pain were r and omised to either grade d activity ( n = 55 ) or usual care ( n = 57 ) . Intervention : Grade d activity , a physical exercise programme aim ed at RTW based on operant-conditioning behavioural principles . Main outcome measures : The number of days off work until first RTW for more then 28 days , total number of days on sick leave during follow up , functional status , and severity of pain . Follow up was 26 weeks . Results : Grade d activity prolonged RTW . Median time until RTW was equal to the total number of days on sick leave and was 139 ( IQR = 69 ) days in the grade d activity group and 111 ( IQR = 76 ) days in the usual care group ( hazard ratio = 0.52 , 95 % CI 0.32 to 0.86 ) . An interaction between a prior workplace intervention and grade d activity , together with a delay in the start of the grade d activity intervention , explained most of the delay in RTW ( hazard ratio = 0.86 , 95 % CI 0.40 to 1.84 without prior intervention and 0.39 , 95 % CI 0.19 to 0.81 with prior intervention ) . Grade d activity did not improve pain or functional status clinical ly significantly . Conclusions : Grade d activity was not effective for any of the outcome measures . Different interventions combined can lead to a delay in RTW . Delay in referral to grade d activity delays RTW . In implementing grade d activity special attention should be paid to the structure and process of care",
"This study was design ed to determine a cost-effective use of psychologist re sources in multimodal cognitive-behavioural treatments ( MMCBT ) for chronic neck/shoulder pain . A r and omised controlled trial was conducted with 66 patients divided in two groups . The first group ( A ) was treated following the approach of MMCBT with the clinical psychologist only functioning as a \" coach \" to the other health professionals . In this group , the psychologist had on average 5 hours of input per patients . The second group ( B ) was treated with the same inpatient MMCBT but with the behavioural component administered by the clinical psychologist directly to the patients . In this second group the psychologist had on average 17 hours of input per patient in the entire intervention . The outcome variables included physical , emotional and social factors , and sick-leave . Both groups showed significant improvements over time . The improvements were evident only in sub-groups , specifically in women . The only significant difference between the groups was in \" perceived helplessness \" favouring the \" psychologist contact \" setting . It is concluded that in terms of input of clinical psychology , the treatment setting with the \" coaching \" technique proved to be the most cost-effective use of the psychologist in the two treatment setting s investigated",
"Sickness absenteeism caused by musculoskeletal disorders ( MSDs ) is a persistent and costly occupational health challenge . In a prospect i ve controlled trial , we compared the effects on sickness absenteeism of a more proactive role for insurance case managers as well as workplace ergonomic interventions with that of traditional case management . Patients with physician-diagnosed MSDs were r and omized either to the intervention group or the reference group offered the traditional case management routines . Participants filled out a comprehensive question naire at the initiation of the study and after 6 months . In addition , administrative data were collected at 0 , 6 , and 12 months after the initiation of the project . For the entire 12-month period , the total mean number of sick days for the intervention group was 144.9 ( SEM 11.8 ) days/person as compared to 197.9 ( 14.0 ) days in the reference group ( P complete rehabilitation investigation ( 84 % versus 27 % ) . The time for doing this was reduced by half ( 59.4 ( 5.2 ) days versus 126.8 ( 19.2 ) , P odds ratio for returning to work in the intervention group was 2.5 ( 95 % confidence interval 1.2–5.1 ) as compared with the reference group . The direct cost savings were USD 1195 per case , yielding a direct benefit-to-cost ratio of 6.8 . It is suggested that the management of MSDs should to a greater degree focus on early return to work and building on functional capacity and employee ability . Allowing the case managers a more active role as well as involving an ergonomist in workplace adaptation meetings might also be beneficial",
"In a r and omized controlled study multimodal cognitive behavioral treatment ( MMCBT ) , including physical treatment , cognitive behavioral modification , education , and examination of the work situation for each patient , was given to patients sick-listed for musculoskeletal pain ( n = 469 ) . Patients were recruited through the National Insurance System . After a pre-test by an independent physiotherapist the patients were allocated at r and om to the intervention group ( n = 312 ) or the control group ( n = 157 ) . The MMBCT program lasted for 4 weeks . The control group returned to their general practitioners , without any feedback or advice on therapy from the project . At the one year follow-up the MMCBT group had not returned to work at a higher rate than the control group receiving ordinary treatment available through their general practitioners . However , the MMCBT group had improved their ergonomic behavior , work potential , life quality , physical , and psychological health",
"Objective . This r and omized clinical trial was design ed to determine the effect of treating low back pain as a benign , self limiting condition by light normal activity . Methods . Patients on sickness leave from work for more than 8 weeks were r and omized into two groups : intervention ( n = 463 ) and control ( n = 512 ) . Those in the intervention group were examined , provided information , and given instruction . Outcome was measured by return or failure to return to work ( still on sickness leave ) . Results . Survival analysis showed a highly significant ( P = 0.000 ) reduction in sickness leave in the intervention group as compared with the control group . At 200 days 60 % were still on sickness leave in the control group vs. 30 % in the intervention group . A multivariate analysis with age , sex , and treatment as cofactors showed that sex had no effect on length of sickness leave and that treatment retained its effect when adjusting for differences in age composition . Conclusion . This study indicates that low back pain treated as a benign , self limiting condition recommended to light mobilization gives superior results as compared to treatment within a conventional medical system",
"CONTEXT Common pain conditions appear to have an adverse effect on work , but no comprehensive estimates exist on the amount of productive time lost in the US workforce due to pain . OBJECTIVE To measure lost productive time ( absence and reduced performance due to common pain conditions ) during a 2-week period . DESIGN AND SETTING Cross-sectional study using survey data from the American Productivity Audit ( a telephone survey that uses the Work and Health Interview ) of working adults between August 1 , 2001 , and July 30 , 2002 . PARTICIPANTS R and om sample of 28 902 working adults in the United States . MAIN OUTCOME MEASURES Lost productive time due to common pain conditions ( arthritis , back , headache , and other musculoskeletal ) expressed in hours per worker per week and calculated in US dollars . RESULTS Thirteen percent of the total workforce experienced a loss in productive time during a 2-week period due to a common pain condition . Headache was the most common ( 5.4 % ) pain condition result ing in lost productive time . It was followed by back pain ( 3.2 % ) , arthritis pain ( 2.0 % ) , and other musculoskeletal pain ( 2.0 % ) . Workers who experienced lost productive time from a pain condition lost a mean ( SE ) of 4.6 ( 0.09 ) h/wk . Workers who had a headache had a mean ( SE ) loss in productive time of 3.5 ( 0.1 ) h/wk . Workers who reported arthritis or back pain had mean ( SE ) lost productive times of 5.2 ( 0.25 ) h/wk . Other common pain conditions result ed in a mean ( SE ) loss in productive time of 5.5 ( 0.22 ) h/wk . Lost productive time from common pain conditions among active workers costs an estimated 61.2 billion dollars per year . The majority ( 76.6 % ) of the lost productive time was explained by reduced performance while at work and not work absence . CONCLUSIONS Pain is an inordinately common and disabling condition in the US workforce . Most of the pain-related lost productive time occurs while employees are at work and is in the form of reduced performance",
"& NA ; Background : Despite evidence suggesting that coping is an important concept in the study of pain , its role in predicting the development of disabling pain has not been previously studied . To assess the relationship between coping and the development of disabling pain . Methods : From a r and om sample of adults , we formed a cohort of individuals with non‐disabling neck and /or low back pain ( n=571 ) . Participants were followed 6 and 12 months after the index survey . Coping was measured with the V and erbilt Pain Management Inventory . The Chronic Pain Question naire was used to measure the presence of disabling neck and /or low back pain . We used Cox proportional hazards regression analyses to investigate the role of passive coping in the development of disabling pain while controlling for confounders . Results : Passive coping was a strong , independent risk factor for disabling neck and /or back pain . Those using moderate to high levels of passive coping strategies were at an over five‐fold increased risk of developing disabling pain ( Moderate : HRR=5.19 , 95 % CI=1.78–15.1 ; High : HRR=6.80 , 95 % CI=2.36–19.6 ) . Active coping was not found to be a significant risk factor for disabling neck and /or back pain . Conclusion : Passive coping is a strong and independent predictor of disabling neck and /or back pain . This strong relationship identifies passive coping as a marker for risk of disability and can allow for the identification of individuals at risk and in need of intervention to aid in improving their overall adjustment",
"BACKGROUND Participatory ergonomics ( PE ) are often applied for prevention of low back pain ( LBP ) . In this pilot- study , a PE-program is applied to the disability management of workers sick listed due to LBP . METHODS The process , implementation , satisfaction , and barriers for implementation concerning the PE-program were analyzed quantitatively and qualitatively for 35 workers sick listed 2 - 6 weeks due to LBP and their ergonomists . RESULTS Two-hundred- and -seventy ergonomic solutions were proposed to the employer . They were targeted more at work design and organization of work ( 58.9 % ) than at workplace and equipment design ( 38.9 % ) . They were planned mostly on a short-term basis ( 74.8 % ) . Almost half ( 48.9 % ) of the solutions for work adjustment were completely or partially implemented within 3 months after the first day of absenteeism . Most workers were satisfied about the PE-program ( median score 7.8 on a 10-point scale ) and reported a stimulating effect on return-to-work ( 66.7 % ) . Main obstacles to implementation were technical or organizational difficulties ( 50.0 % ) and physical disabilities of the worker ( 44.8 % ) . CONCLUSIONS This study suggests that compliance , acceptance , and satisfaction related to the PE-program were good for all participants . Almost half of the proposed solutions were implemented",
"Study design . Population -based r and omized controlled trial . Objective . To assess the effectiveness of workplace intervention and grade d activity , separately and combined , for multidisciplinary rehabilitation of low back pain ( LBP ) . Summary of Background Data . Effective components for multidisciplinary rehabilitation of LBP are not yet established . Methods . Participants sick-listed 2 to 6 weeks due to nonspecific LBP were r and omized to workplace intervention ( n = 96 ) or usual care ( n = 100 ) . Workplace intervention consisted of workplace assessment , work modifications , and case management involving all stakeholders . Participants still sick-listed at 8 weeks were r and omized for grade d activity ( n = 55 ) or usual care ( n = 57 ) . Grade d activity comprised biweekly 1-hour exercise sessions based on operant-conditioning principles . Outcomes were lasting return to work , pain intensity and functional status , assessed at baseline , and at 12 , 26 , and 52 weeks after the start of sick leave . Results . Time until return to work for workers with workplace intervention was 77 versus 104 days ( median ) for workers without this intervention ( P = 0.02 ) . Workplace intervention was effective on return to work ( hazard ratio = 1.7 ; 95 % CI , 1.2–2.3 ; P = 0.002 ) . Grade d activity had a negative effect on return to work ( hazard ratio = 0.4 ; 95 % CI , 0.3–0.6 ; P functional status . Combined intervention had no effect . Conclusion . Workplace intervention is advised for multidisciplinary rehabilitation of subacute LBP . Grade d activity or combined intervention is not advised",
"Study Design . A r and omized controlled trial in occupational health practice was conducted . Objective . To study the efficacy of early management of workers with low back pain by occupational physicians , as compared with management by the supervisor only . Summary of Background data . Health care and university workers with back pain and on sick leave for less than 1 month were included in the study . Methods . Patients with low back pain for at least 10 days on sick leave were r and omly assigned to early management by the occupational physician ( n = 61 ) or to a reference group with management by the worker ’s supervisor during the first 3 months of sick leave ( n = 59 ) . The patients were observed for 1 year and compared in terms of time until return to work , pain intensity , functional disability , and general health perception . The occupational physicians were provided with management guidelines . Results . No significant differences were found after 3 and 12 months of follow-up evaluation in terms of time until return to work ( hazard ratio , 1.3 ; 95 % CI , 0.90–1.90 ) or in terms of other health outcomes . Recurrences , however , occurred more frequently in the intervention group , but the total duration of sick leave in 1 year did not differ between the groups . Conclusions . The findings do not show a significant positive effect of an early intervention by occupational physicians on workers with low back pain . This might reflect the early phase of disability or the low intensity of the intervention result ing from overestimation of the physicians ’ compliance with the guidelines",
"Study Design . A r and omized controlled trial comparing usual care with a program for the coordination of primary health care ( CORE ) for the treatment of subacute low-back pain patients . Objectives . To measure the effectiveness of the CORE program as a mean for implementing clinical practice guidelines for low-back pain in an urban community . Summary of Background Data . Clinical practice guidelines have been developed for primary care physicians and patients on the clinical management of low-back pain . The implementation of the guidelines in a large community is difficult with the multiplicity of medical and nonmedical back care providers and products . The CORE program was design ed to make the guidelines fit in this complex environment . Methods . One hundred ten workers compensated for low-back pain for 4 to 8 weeks in metropolitan Montreal were r and omized in two groups : usual care ( N=56 ) and the CORE program ( N=54 ) . Coordination of primary health care was performed by two primary care physicians and a nurse in liaison with the treating physicians , and included a complete examination , recommendations for the clinical management , and support to carry out the recommendations . All workers were followed for 6 months . Back pain and functional status were assessed at baseline , 3 months , and 6 months . Results . In the 6-month follow-up , the CORE group returned to work 6.6 days ( st and ard error = 8.9 ) quicker than the control group , a difference that was not statistically significant . However , the CORE group showed a sustained improvement in pain and functional status with two-fold differences at the end of the 6 months of follow-up . This represented nine points on the Oswestry scale ( P = 0.02 ) and 12 points on the Quebec Back Pain Disability Scale ( P = 0.01 ) . The CORE group also used three times less specialized imaging tests of the spine at 3 months ( P workers with low-back pain could be improved by implementing the clinical practice guidelines with primary care physicians in a large community , without delaying the return to work . The CORE intervention for back pain patients ishighly relevant to primary care practice . It is simple in its application , flexible to accommo date physicians ’ and patients ’ preferences in health care , and it is effective on patients ’ clinical outcome"
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The prevalence and incidence of overweight and obesity worldwide continues to increase , as well as diseases related to these conditions . This is attributed to an increase in energy intake and a decrease in energy expenditure . Consumption of green tea has been linked to a reduction in body fat and body weight . However , research on green tea has been very diverse . This review assesses the investigations that have been made with green tea and its epigallocatechin gallato ( EGCG ) content , evaluating its effect on body fat and body weight in humans . A search was made in the PubMed and Web of the Science data bases that gave a first total result of 424 potential articles ; 409 were excluded and 15 articles were used for this systematic review . Research has been very varied , however , daily consumption of green tea with doses of EGCG between 100 and 460 mg/day has shown greater effectiveness on body fat and body weight reduction in intervention periods of 12 weeks or more . In addition , the use of caffeine doses between 80 and 300 mg/day has been shown to be an important factor for this effects , when the participants did not have a high caffeine intake ( > 300 mg/day ) prior to the intervention | [
"BACKGROUND Current interest in the role of functional foods in weight control has focused on plant ingredients capable of interfering with the sympathoadrenal system . OBJECTIVE We investigated whether a green tea extract , by virtue of its high content of caffeine and catechin polyphenols , could increase 24-h energy expenditure ( EE ) and fat oxidation in humans . DESIGN Twenty-four-hour EE , the respiratory quotient ( RQ ) , and the urinary excretion of nitrogen and catecholamines were measured in a respiratory chamber in 10 healthy men . On 3 separate occasions , subjects were r and omly assigned among 3 treatments : green tea extract ( 50 mg caffeine and 90 mg epigallocatechin gallate ) , caffeine ( 50 mg ) , and placebo , which they ingested at breakfast , lunch , and dinner . RESULTS Relative to placebo , treatment with the green tea extract result ed in a significant increase in 24-h EE ( 4 % ; P decrease in 24-h RQ ( from 0.88 to 0.85 ; P . Twenty-four-hour urinary norepinephrine excretion was higher during treatment with the green tea extract than with the placebo ( 40 % , P EE and RQ nor on urinary nitrogen or catecholamines . CONCLUSIONS Green tea has thermogenic properties and promotes fat oxidation beyond that explained by its caffeine content per se . The green tea extract may play a role in the control of body composition via sympathetic activation of thermogenesis , fat oxidation , or both",
"The consumption of green tea has been associated with cardiovascular and metabolic diseases . There have been some studies on the influence of green tea on the mineral status of obese subjects , but they have not yielded conclusive results . The aim of the present study is to examine the effects of green tea extract on the mineral , body mass , lipid profile , glucose , and antioxidant status of obese patients . A r and omized , double-blind , placebo-controlled study was conducted . Forty-six obese patients were r and omly assigned to receive either 379 mg of green tea extract , or a placebo , daily for 3 months . At baseline , and after 3 months of treatment , the anthropometric parameters , blood pressure , and total antioxidant status were assessed , as were the levels of plasma lipids , glucose , calcium , magnesium , iron , zinc , and copper . We found that 3 months of green tea extract supplementation result ed in decreases in body mass index , waist circumference , and levels of total cholesterol , low-density cholesterol , and triglyceride . Increases in total antioxidant level and in zinc concentration in serum were also observed . Glucose and iron levels were lower in the green tea extract group than in the control , although HDL-cholesterol and magnesium were higher in the green tea extract group than in the placebo group . At baseline , a positive correlation was found between calcium and body mass index , as was a negative correlation between copper and triglycerides . After 3 months , a positive correlation between iron and body mass index and between magnesium and HDL-cholesterol , as well as a negative correlation between magnesium and glucose , were observed . The present findings demonstrate that green tea influences the body 's mineral status . Moreover , the results of this study confirm the beneficial effects of green tea extract supplementation on body mass index , lipid profile , and total antioxidant status in patients with obesity",
"This study was undertaken to investigate the effects of green tea on weight reduction in obese Thais . A r and omized , controlled trial involving 60 obese subjects ( body mass index , BMI > 25 kg/m2 ) was conducted . All subjects consumed a Thai diet containing 3 meals ( 8373.6 kJ/day ) for 12 weeks , prepared by the Nutritional Unit at Srinagarind Hospital . The diet contained 65 % carbohydrates , 15 % protein , and 20 % fat . Body weight , BMI , body composition , resting energy expenditure , and substrate oxidation were measured at baseline , and during weeks 4 , 8 , and 12 of the study . Serum levels of leptin and urine VMA were measured at baseline and during the 12th week . Differences over time and between the treatments ( green tea or placebo ) over time were determined using two-factor ANOVA with repeated measures . In comparing the two groups , differences in weight loss were 2.70 , 5.10 , and 3.3 kg during the 4th , 8th , and 12th weeks of the study , respectively . At the 8th and 12th weeks of the study , body weight loss was significantly different ( P in resting energy expenditure was 183.38 kJ/day ( P the respiratory quotient was 0.02 ( P satiety score , food intake , or physical activity . Urine VMA was significantly different in the 12th week of the study ( P that green tea can reduce body weight in obese Thai subjects by increasing energy expenditure and fat oxidation",
"This study evaluated the influence of a green tea catechin beverage on body composition and fat distribution in overweight and obese adults during exercise-induced weight loss . Participants ( n = 132 with 107 completers ) were r and omly assigned to receive a beverage containing approximately 625 mg of catechins with 39 mg caffeine or a control beverage ( 39 mg caffeine , no catechins ) for 12 wk . Participants were asked to maintain constant energy intake and engage in > or=180 min/wk moderate intensity exercise , including > or=3 supervised sessions per week . Body composition ( dual X-ray absorptiometry ) , abdominal fat areas ( computed tomography ) , and clinical laboratory tests were measured at baseline and wk 12 . There was a trend ( P = 0.079 ) toward greater loss of body weight in the catechin group compared with the control group ; least squares mean ( 95 % CI ) changes , adjusted for baseline value , age , and sex , were -2.2 ( -3.1 , -1.3 ) and -1.0 ( -1.9 , -0.1 ) kg , respectively . Percentage changes in fat mass did not differ between the catechin [ 5.2 ( -7.0 , -3.4 ) ] and control groups [ -3.5 ( -5.4 , 1.6 ) ] ( P = 0.208 ) . However , percentage changes in total abdominal fat area [ -7.7 ( -11.7 , -3.8 ) vs. -0.3 ( -4.4 , 3.9 ) ; P = 0.013 ] , subcutaneous abdominal fat area [ -6.2 ( -10.2 , -2.2 ) vs. 0.8 ( -3.3 , 4.9 ) ; P = 0.019 ] , and fasting serum triglycerides ( TG ) [ -11.2 ( -18.8 , -3.6 ) vs. 1.9 ( -5.9 , 9.7 ) ; P = 0.023 ] were greater in the catechin group . These findings suggest that green tea catechin consumption enhances exercise-induced changes in abdominal fat and serum TG",
"Objectives : To study the effects of green tea on body weight , and biochemical and hormonal profiles in obese Chinese women with polycystic ovary syndrome ( PCOS ) . Methods : Thirty-four obese Chinese women with PCOS were r and omized into either treatment with green tea capsules or placebo for 3 months . The anthropomentric measurements , and biochemical and hormonal profiles before and after treatment in each group were compared . Results : The body weight of the green tea group decreased by a nonsignificant 2.4 % after treatment ; whereas the body weight , body mass index ( BMI ) , and body fat content of the control group were significantly higher after 3 months . There were no differences in any of the hormone levels measured in either group . The biochemical profiles of the two groups were also similar except that there was a small but significant rise in the triglyceride level in the green tea group . Fewer patients in the green tea group remained amenorrhoeic , but this was not significantly different from the control group . Conclusions : Green tea supplementation did not significantly reduce body weight in obese women with PCOS , nor did it alter the glucose or lipid metabolism",
"The present study was conducted to investigate whether green tea may improve weight maintenance by preventing or limiting weight regain after weight loss of 5 to 10 % in overweight and moderately obese subjects . The study had a r and omised , parallel , placebo-controlled design . A total of 104 overweight and moderately obese male and female subjects ( age 18 - 60 years ; BMI 25 - 35 kg/m(2 ) ) participated . The study consisted of a very-low-energy diet intervention ( VLED ; 2.1 MJ/d ) of 4 weeks followed by a weight-maintenance period of 13 weeks in which the subjects received green tea or placebo . The green tea contained caffeine ( 104 mg/d ) and catechins ( 573 mg/d , of which 323 mg was epigallocatechin gallate ) . Subjects lost 6.4 ( sd 1.9 ) kg or 7.5 ( sd 2.2 ) % of their original body weight during the VLED ( P Body-weight regain was not significantly different between the green tea and the placebo group ( 30.5 ( sd 61.8 ) % and 19.7 ( sd 56.9 ) % , respectively ) . In the green tea treatment , habitual high caffeine consumption was associated with a higher weight regain compared with habitual low caffeine consumption ( 39 ( sd 17 ) and 16 ( sd 11 ) % , respectively ; P weight maintenance after 7.5 % body-weight loss was not affected by green tea treatment and that habitual caffeine consumption affected weight maintenance in the green tea treatment",
"Regular consumption of green tea may be cardioprotective . In the present study we investigated the health effects of dietary supplementation with green tea catechins and the potential modifying effect of the catechol-O-methyltransferase ( COMT ) Val/Met genotype . Subjects ( sedentary males , aged 40 - 69 years , with BMI ≥ 28 and ≤ 38 kg/m(2 ) ) were r and omly assigned to consume decaffeinated green tea extract ( DGT ; 530 mg containing about 400 mg total catechins/capsule , twice daily ) and placebo in a complete cross-over design . Ambulatory blood pressure and biomarkers of metabolic function ( cholesterol , TAG , glucose and insulin ) were measured at weeks 0 and 6 . Although a marked increase in the concentration of plasma epigallocatechin gallate ( EGCG ) , urinary epigallocatechin ( EGC ) and urinary 4'-O-methyl EGC was found after DGT treatment , no effect on blood pressure or biomarkers of metabolic function was observed . However , a period × treatment interaction ( P for body-weight change . Despite a similar increase in estimated energy intake during intervention period 1 , body weight decreased by 0·64 ( sd 2·2 ) kg and increased by 0·53 ( sd 1·9 ) kg in the DGT and placebo groups , respectively ( P = 0·025 ) , suggesting a protective effect of green tea catechins on weight gain . Additionally , the COMT Val/Met genotype influenced urinary accumulation of EGC and 4'-O-methyl EGC ( P . Mean concentrations were lower in individuals homozygous for the high-activity G-allele , possibly reflecting increased metabolic flux and a more rapid conversion to downstream metabolic species , compared with individuals carrying at least one copy of the low-activity A-allele . Additional studies are needed to confirm these findings and further explore the modifying effect of genotype",
"AIMS To examine the effect of green tea extract ( GTE ) on obese women and to explore the relationship between GTE and obesity-related hormone peptides . METHODS A r and omized , double-blind , placebo-controlled clinical trial was conducted from July 2006 to June 2007 in Taipei Hospital , Taiwan . Seventy-eight of 100 obese women aged between 16 and 60 years with BMI > 27 kg/m(2 ) and who had not received any other weight control maneuvers within the last 3 months completed this study . The subjects were r and omly divided into Groups A and B. Group A ( n=41 ) received GTE while Group B ( n=37 ) took cellulose as a placebo , one capsule ( 400 mg ) three times each day for 12 weeks . The body weight ( BW ) , body mass index ( BMI ) and waist circumflex ( WC ) were measured at the beginning of the study and after 12 weeks of treatment with GTE . The data were compared and expressed as % reduction . RESULTS There was only a 0.3 % reduction in BW ( 0.15 kg ) after 12 weeks of treatment with GTE . There was no statistical difference in % reduction in BW , BMI and WC between the GTE and placebo groups . Within group comparison revealed that the GTE group had significant reduction in LDL-cholesterol and triglyceride , and marked increase in the level of HDL-cholesterol , adiponectin and ghrelin . On the other h and , the placebo group showed significant reduction in triglyceride only , and a marked increase in the level of ghrelin alone . CONCLUSIONS This study showed no statistical difference in % reduction in BW , BMI and WC between the GTE and placebo groups after 12 weeks of treatment . The intake of GTE ( 491 mg catechins containing 302 mg EGCG ) for 12 weeks is considered safe as shown by the results",
"OBJECTIVE The body fat reducing effect and reduction of risks for cardiovascular disease by a green tea extract ( GTE ) high in catechins was investigated in humans with typical lifestyles . RESEARCH METHODS AND PROCEDURES Japanese women and men with visceral fat-type obesity were recruited for the trial . After a 2-week diet run-in period , a 12-week double-blind parallel multicenter trial was performed , in which the subjects ingested green tea containing 583 mg of catechins ( catechin group ) or 96 mg of catechins ( control group ) per day . R and omization was stratified by gender and body mass index at each medical institution . The subjects were instructed to maintain their usual dietary intake and normal physical activity . RESULTS Data were analyzed using per- protocol sample s of 240 subjects ( catechin group ; n = 123 , control group ; n = 117 ) . Decreases in body weight , body mass index , body fat ratio , body fat mass , waist circumference , hip circumference , visceral fat area , and subcutaneous fat area were found to be greater in the catechin group than in the control group . A greater decrease in systolic blood pressure ( SBP ) was found in the catechin group compared with the control group for subjects whose initial SBP was 130 mm Hg or higher . Low-density lipoprotein ( LDL ) cholesterol was also decreased to a greater extent in the catechin group . No adverse effect was found . DISCUSSION The continuous ingestion of a GTE high in catechins led to a reduction in body fat , SBP , and LDL cholesterol , suggesting that the ingestion of such an extract contributes to a decrease in obesity and cardiovascular disease risks",
"BACKGROUND Green tea extract ( GTE ) consumption has been linked to favorable changes in adiposity and bone mineral density ( BMD ) , although it is unknown if these effects are due to green tea catechins or caffeine . The catechol-O-methyltransferase ( COMT ) genotype may also modify these associations . OBJECTIVE We examined the impact of decaffeinated GTE on body composition ( using dual-energy X-ray absorptiometry ) and obesity-associated hormones . METHODS The Minnesota Green Tea Trial was a 12-mo r and omized , double-blind , placebo-controlled clinical trial in 937 postmenopausal women ( aged 50 - 70 y ) assigned to receive either GTE containing 843 mg (-)-epigallocatechin-3-gallate or placebo . This sub study was conducted in 121 overweight/obese participants [ body mass index ( BMI ) ( kg/m(2 ) ) ≥25.0 ] . RESULTS There were no differences in changes in BMI ( -0.13 ± 0.11 compared with -0.05 ± 0.11 ; P = 0.61 ) , total fat mass ( -0.30 ± 0.16 compared with -0.12 ± 0.15 kg ; P = 0.40 ) , percentage of body fat ( -0.15 % ± 0.17 % compared with -0.15 % ± 0.16 % ; P = 0.99 ) , or BMD ( -0.006 ± 0.002 compared with -0.003 ± 0.002 g/cm(2 ) ; P = 0.49 ) over 12 mo between women taking GTE ( n = 61 ) and those taking a placebo ( n = 60 ) . Interactions were observed between treatment and time for gynoid percentage of fat ( % fat ) and tissue % fat . Gynoid % fat increased from baseline to month 12 in the placebo group as baseline BMI increased and decreased over time as baseline BMI increased in the GTE group ( P-interaction = 0.02 ) . Tissue % fat increased from baseline to month 12 in the placebo group as baseline BMI increased . In the GTE group , tissue % fat decreased during the intervention as baseline BMI increased ( P-interaction = 0.04 ) . No changes were seen in circulating leptin , ghrelin , adiponectin , or insulin concentrations . COMT genotype did not modify the effect of GTE on any variable . CONCLUSIONS Decaffeinated GTE was not associated with overall reductions in adiposity or improvements in BMD in overweight/obese postmenopausal women . However , GTE may be beneficial for reduction in tissue and gynoid % fat in individuals with higher BMI . This clinical trial was registered at www . clinical trials.gov as NCT00917735"
] | 41162acc-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE To systematic ally review the literature pertaining to the reversal of type 2 diabetes mellitus ( DM2 ) after Roux-en-Y gastric bypass and adjustable gastric b and ing . DATA SOURCES We conducted a review of the literature using PubMed and search ed the reference lists of published studies to identify additional studies . STUDY SELECTION We selected all published articles that were relevant with respect to bariatric surgery and its metabolic effects . DATA EXTRACTION Only 9 original articles reporting on DM2 reversal rates after bariatric surgery were identified : 1 r and omized controlled trial and 8 observational studies . Other referenced articles serve as background literature . DATA SYNTHESIS Roux-en-Y gastric bypass leads to a reversal rate of DM2 of 83 % . Adjustable gastric b and ing confers a reversal rate of 62 % , and this effect is achieved later after surgery . CONCLUSIONS Bariatric surgery leads to marked and long-lasting weight reduction . A large proportion of patients undergoing bariatric surgery have DM2 . In fact , the presence of diabetes mellitus is a compelling argument to perform bariatric surgery in those who are eligible according to international criteria . Glycemic control improves in the months after laparoscopic adjustable gastric b and ing , but it improves more rapidly and completely after laparoscopic Roux-en-Y gastric bypass surgery . Thus , both types of surgery are capable of improving or even curing DM2 , but the mechanisms may differ | [
"OBJECTIVE To prospect ively examine the effect of weight loss 1 year after laparoscopic adjustable gastric b and surgery on a broad range of health outcomes in 50 diabetic subjects . RESEARCH DESIGN AND METHODS A total of 50 ( 17 men , 33 women ) of 51 patients with type 2 diabetes , from a total of 500 consecutive patients , were studied preoperatively and again 1 year after surgery . RESULTS Preoperative weight and BMI ( means + /- SD ) were 137 + /- 30 kg and 48.2 + /- 8 kg/m(2 ) , respectively ; at 1 year , weight and BMI were 110 + /- 24 kg and 38.7 + /- 6 kg/m(2 ) , respectively . There was significant improvement in all measures of glucose metabolism . Remission of diabetes occurred in 32 patients ( 64 % ) , and major improvement of glucose control occurred in 13 patients ( 26 % ) ; glucose metabolism was unchanged in 5 patients ( 10 % ) . HbA(1c ) was 7.8 + /- 3.2 % preoperatively and 6.2 + /- 2.7 % at 1 year ( P Remission of diabetes was predicted by greater weight loss and a shorter history of diabetes ( pseudo r(2 ) = 0.44 , P Improvement in diabetes was related to increased insulin sensitivity and beta-cell function . Weight loss was associated with significant improvements in fasting triglyceride level , HDL cholesterol level , hypertension , sleep , depression , appearance evaluation , and health-related quality of life . Early complications occurred in 6 % of patients ( wound infections in 4 % , respiratory support in 2 % ) , and late complications occurred in 30 % of patients ( gastric prolapse in 20 % , b and erosion in 6 % , and tubing leaks in 4 % ) . All late complications were successfully revised surgically . CONCLUSIONS Modern laparoscopic weight-loss surgery is effective in managing the broad range of health problems experienced by severely obese individuals with type 2 diabetes . Surgery should be considered as an early intervention",
"BACKGROUND A very-low-energy diet ( VLED ) can result in substantial , rapid weight loss and is increasingly prescribed before obesity surgery to minimize risk and difficulty by reducing liver size and abdominal adiposity . Despite its growing popularity , a VLED in this setting has received little attention . OBJECTIVE The aim of this study was to investigate the efficacy and acceptability of a preoperative VLED . DESIGN In a prospect i ve observational study , 32 subjects ( n = 19 men and 13 women ) with a mean ( + /-SD ) age of 47.5 + /- 8.3 y and a body mass index ( in kg/m(2 ) ) of 47.3 + /- 5.3 consumed a VLED for 12 wk . Primary outcomes included changes in liver volume ( LV ) and in visceral and subcutaneous adipose tissue ( VAT/SAT ) . Changes in body weight , anthropometric measures , and biochemical variables were also recorded , and compliance with , acceptability of , and side effects of treatment were assessed . Changes in LV and VAT/SAT area were measured by computed tomography and magnetic resonance imaging at baseline and weeks 2 , 4 , 8 , and 12 . RESULTS Mean ( + /-SD ) LV , VAT/SAT , and body weight decreased significantly ( P LV reduction was directly related to the reduction in relative body weight ( r = 0.54 , P = 0.001 ) and initial LV ( r = 0.43 , P = 0.015 ) . Eighty percent of the reduction in LV occurred between weeks 0 and 2 ( P body weight and VAT were uniform over the 12-wk period . Attrition was 14 % . Acceptability was adequate but waned over time , and mild transitory side effects occurred . CONCLUSIONS Given the observed early reduction in LV and the progressive reduction in VAT , we suggest that the minimum duration for a preoperative VLED be 2 wk . Ideally , the duration should be 6 wk to achieve maximal LV reduction and significant reductions in VAT and body weight without compromising compliance and acceptability",
"BACKGROUND Gastric bypass ( GBP ) is the most common operation performed in the United States for morbid obesity . However , weight loss is poor in 10 % to 15 % of patients . We sought to determine the independent factors associated with poor weight loss after GBP . DESIGN Prospect i ve cohort study . We examined demographic , operative , and follow-up data by means of multivariate analysis . Variables investigated were age , sex , race , marital and insurance status , initial weight and body mass index ( BMI ) ( calculated as weight in kilograms divided by height in meters squared ) , comorbidities ( diabetes mellitus , hypertension , joint disease , sleep apnea , hyperlipidemia , and psychiatric disease ) , laparoscopic vs open surgery , gastric pouch area , gastrojejunostomy technique , and alimentary limb length . SETTING University tertiary referral center . PATIENTS All patients at our institution who underwent GBP from January 1 , 2003 , through July 30 , 2006 . MAIN OUTCOME MEASURES Weight loss at 12 months defined as poor ( 40 % excess weight loss ) . RESULTS Follow-up data at 12 months were available for 310 of the 361 patients ( 85.9 % ) undergoing GBP during the study period . Mean preoperative BMI was 52 ( range , 36 - 108 ) . Mean BMI and excess weight loss at follow-up were 34 ( range , 17 - 74 ) and 60 % ( range , 8%-117 % ) , respectively . Thirty-eight patients ( 12.3 % ) had poor weight loss . Of the 4 variables associated with poor weight loss in the univariate analysis ( greater initial weight , diabetes , open approach , and larger pouch size ) , only diabetes ( odds ratio , 3.09 ; 95 % confidence interval , 1.35 - 7.09 [ P = .007 ] ) and larger pouch size ( odds ratio , 2.77;95 % confidence interval , 1.81 - 4.22 [ P Gastric bypass results in substantial weight loss in most patients . Diabetes and larger pouch size are independently associated with poor weight loss after GBP",
"OBJECTIVE To assess the cost-effectiveness of Roux-en-Y gastric bypass for treating type 2 diabetes mellitus ( T2DM ) in the United States compared with st and ard medical management , using clinical data from a prospect i ve observational study conducted at an academic medical center . STUDY DESIGN Our study used a predictive health economic model ( the CORE Diabetes Model ) to project the long-term costs and clinical effectiveness of Roux-en-Y gastric bypass as a treatment for T2DM using the prospect i ve observational study as the basis for our clinical effectiveness assumptions . METHODS The CORE Diabetes Model used Monte Carlo simulation with tracker variables to estimate the lifetime costs and clinical outcomes of Roux-en-Y gastric bypass compared with st and ard medical management of obese T2DM patients . Sensitivity analyses were performed on key clinical assumptions , discount rates , and shorter time horizons . RESULTS The base-case scenario yielded an incremental cost-effectiveness ratio ( ICER ) of $ 21,973 per quality -adjusted life-year ( QALY ) gained . In sensitivity analyses , shortening the time horizon to 5 and 10 years and excluding the negative impact of increased body mass index on the patient 's quality of life had the greatest adverse impact on the ICERs ( ie , higher cost per QALY ) . CONCLUSIONS Under base-case assumptions , Roux-en-Y gastric bypass is cost-effective in the treatment of T2DM in the United States with an ICER below $ 50,000 per QALY gained . Sensitivity analyses indicated that bariatric surgery is not cost-effective over shorter time horizons , or if the negative quality -of-life impact of increased body mass index is ignored",
"Objective This report documents that the gastric bypass operation provides long-term control for obesity and diabetes . Summary Background Data Obesity and diabetes , both notoriously resistant to medical therapy , continue to be two of our most common and serious diseases . Methods Over the last 14 years , 608 morbidly obese patients underwent gastric bypass , an operation that restricts caloric intake by ( 1 ) reducing the functional stomach to approximately 30 mL , ( 2 ) delaying gastric emptying with a c. 0.8 to 1.0 cm gastric outlet , and ( 3 ) excluding foregut with a 40 to 60 cm Roux-en-Y gastrojejunostomy . Even though many of the patients were seriously ill , the operation was performed with a perioperative mortality and complication rate of 1.5 % and 8.5 % , respectively . Seventeen of the 608 patients ( Gastric bypass provides durable weight control . Weights fell from a preoperative mean of 304.4 lb ( range , 198 to 615 lb ) to 192.2 lb ( range , 104 to 466 ) by 1 year and were maintained at 205.4 lb ( range , 107 to 512 lb ) at 5 years , 206.5 lb ( 130 to 388 lb ) at 10 years , and 204.7 lb ( 158 to 270 lb ) at 14 years . The operation provides long-term control of non-insulin-dependent diabetes mellitus ( NIDDM ) . In those patients with adequate follow-up , 121 of 146 patients ( 82.9 % ) with NIDDM and 150 of 152 patients ( 98.7 % ) with glucose impairment maintained normal levels of plasma glucose , glycosylated hemoglobin , and insulin . These antidiabetic effects appear to be due primarily to a reduction in caloric intake , suggesting that insulin resistance is a secondary protective effect rather than the initial lesion . In addition to the control of weight and NIDDM , gastric bypass also corrected or alleviated a number of other comorbidities of obesity , including hypertension , sleep apnea , cardiopulmonary failure , arthritis , and infertility",
"Aims /hypothesisBoth energy restriction ( ER ) per se and weight loss improve glucose metabolism in obese insulin-treated type 2 diabetic patients . Short-term ER decreases basal endogenous glucose production ( EGP ) but not glucose disposal . In contrast the blood glucose-lowering mechanism of long-term ER with substantial weight loss has not been fully eluci date d. The aim of this study was to investigate the effect of loss of 50 % of excess weight [ 50 % excess weight reduction ( EWR ) ] on EGP , whole-body insulin sensitivity and the disturbed myocellular insulin-signalling pathway in ten obese insulin-treated type 2 diabetic patients . Methods A euglycaemic – hyperinsulinaemic clamp with stable isotopes ( [6,6 - 2H2]glucose and [2H5]glycerol ) combined with skeletal muscle biopsies was performed during a very low energy diet ( VLED ; 1,883 kJ/day ) on day 2 and again after 50 % EWR . Oral blood glucose-lowering agents and insulin were discontinued 3 weeks prior to the VLED and at the start of the VLED , respectively . Results Loss of 50 % EWR ( 20.3 ± 2.2 kg from day 2 to day of 50 % EWR ) normalised basal EGP and improved insulin sensitivity , especially insulin-stimulated glucose disposal ( 18.8 ± 2.0 to 39.1 ± 2.8 μmol kg fat-free mass−1 min−1 , p = 0.001 ) . The latter was accompanied by improved insulin signalling at the level of the recently discovered protein kinase B/Akt substrates AS160 and PRAS40 along with a decrease in intramyocellular lipid ( IMCL ) content . Conclusions /interpretationConsiderable weight loss in obese , insulin-treated type 2 diabetic patients normalises basal EGP and improves insulin sensitivity result ing from an improvement in insulin signal transduction in skeletal muscle . The decrease in IMCL might contribute to this effect",
"Background : Biliopancreatic diversion with duodenal switch ( BPD-DS ) is an operation which provides one of the greatest maintained weight losses of any bariatric procedure . We looked at the safety and efficacy of laparoscopic BPD-DS for morbid obesity . Methods : A 150 - 200 ml sleeve gastrectomy was created and anastomosed to the distal 250 cm of divided ileum . The median length of the common channel was 100 cm . All patients were prospect ively followed up to 12 months . Results : 40 consecutive patients underwent laparoscopic BPD-DS as a primary procedure for morbid obesity . Median patient body mass index ( BMI ) was 60 kg/m2 ( range 42 - 85 kg/m2 ) . Mean age was 43 ± 1 years ( ± SEM ) , with 12 males and 28 females . One patient was converted to open laparotomy ( 2.5 % ) . Median operative time was 210 ± 9 minutes ( range 110 - 360 minutes ) with a significant correlation between BMI and operative time ( p = 0.04 ) . Median length of stay was 4 days ( range 3- 210 days ) . There was one 30-day mortality ( 2.5 % ) . Major morbidities occurred in 6 patients ( 15 % ) , including 1 anastomotic leak ( 2.5 % ) , 1 venous thrombosis ( 2.5 % ) , 4 staple-line hemorrhages ( 10 % ) and 1 subphrenic abscess ( 2.5 % ) . Median follow-up at 6 months ( range 1 - 12 months ) result ed in 46 % ± 2 % excess weight loss ( EWL ) and at 9 months 58 % ± 3 % EWL . Conclusion : Laparoscopic BPD-DS is a complex , yet feasible , procedure result ing in effective weight loss with an acceptable morbidity . A BMI > 65 was associated with increased morbidity and mortality . A long-term study is needed to confirm efficacy and proper patient selection",
"Background : Gastric bypass and adjustable gastric b and ing are the 2 most commonly performed bariatric procedures for the treatment of morbid obesity . The aim of this study was to compare the outcomes , quality of life , and costs of laparoscopic gastric bypass versus laparoscopic gastric b and ing . Study Design : Between 2002 and 2007 , 250 patients with a body mass index of 35 to 60 kg/m2 were r and omly assigned to gastric bypass or gastric b and ing . After exclusion , 111 patients underwent gastric bypass and 86 patients underwent gastric b and ing . Outcome measures included demographic data , operative time , blood loss , length of hospital stay , morbidity , mortality , early and late reoperation rate , weight loss , changes in quality of life , and cost . Treatment failure was defined as losing less than 20 % of excess weight or conversion to another bariatric operation for failure of weight loss . Results : There were no deaths at 90 days in either group . The mean body mass index was higher in the gastric bypass group ( 47.5 vs. 45.5 kg/m2 , respectively , P gastric b and ing , operative blood loss was higher and the mean operative time and length of stay were longer in the gastric bypass group . The 30-day complication rate was higher after gastric bypass ( 21.6 % vs. 7.0 % for gastric b and ) ; however , there were no life-threatening complications such as leaks or sepsis . The most frequent late complication in the gastric bypass group was stricture ( 14.3 % ) . The 1-year mortality was 0.9 % for the gastric bypass group and 0 % for the gastric b and group . The percent of excess weight loss at 4 years was higher in the gastric bypass group ( 68 ± 19 % vs. 45 ± 28 % , respectively , P Treatment failure occurred in 16.7 % of the patients who underwent gastric b and ing and in 0 % of those who underwent gastric bypass , with male gender being a predictive factor for poor weight loss after gastric b and ing . At 1-year postsurgery , quality of life improved in both groups to that of US norms . The total cost was higher for gastric bypass as compared with gastric b and ing procedure ( $ 12,310 vs. $ 10,766 , respectively , P and gastric b and ing are both safe and effective approaches for the treatment of morbid obesity . Gastric bypass result ed in better weight loss at medium- and long-term follow-up but was associated with more perioperative and late complications and a higher 30-day readmission rate . There was a wide variation in weight loss after gastric b and ing with a small proportion of patients considered as treatment failure , and male gender was a predictive factor for poor weight loss",
"Summary Glucagon-like peptide 1 ( GLP-1 ) ( 7 - 36 amide ) is a physiological incretin hormone that is released after nutrient intake from the lower gut and stimulates insulin secretion at elevated plasma glucose concentrations . Previous work has shown that even in Type 2 ( non-insulin-dependent ) diabetic patients GLP-1 ( 7 - 36 amide ) retains much of its insulinotropic action . However , it is not known whether the magnitude of this response is sufficient to normalize plasma glucose in Type 2 diabetic patients with poor metabolic control . Therefore , in 10 Type 2 diabetic patients with unsatisfactory metabolic control ( HbAlc 11.6±1.7 % ) on diet and sulphonylurea therapy ( in some patients supplemented by metformin or acarbose ) , 1.2 pmol ×kg−1 × min−1 GLP-1 ( 7 - 36 amide ) or placebo was infused intravenously in the fasting state ( plasma glucose 13.1±0.6 mmol/l ) . In all patients , insulin ( by 17.4±4.7 nmol ×1−1 × min ; p=0.0157 ) and C-peptide ( by 228.0±39.1 nmol × 1−1 × min ; p=0.0019 ) increased significantly over basal levels , glucagon was reduced ( by -1418±308 pmol ×1−1 × min ) and plasma glucose reached normal fasting concentrations ( 4.9±0.3 mmol/l ) within 4 h of GLP-1 ( 7 - 36 amide ) administration , but not with placebo . When normal fasting plasma glucose concentrations were reached insulin returned towards basal levels and plasma glucose concentrations remained stable despite the ongoing infusion of GLP-1 ( 7 - 36 amide ) . Therefore , exogenous GLP-1 ( 7 - 36 amide ) is an effective means of normalizing fasting plasma glucose concentrations in poorly-controlled Type 2 diabetic patients . The glucose-dependence of insulinotropic actions of GLP-1 ( 7 - 36 amide ) appears to be retained in such patients",
"Background : Severe obesity is associated with type 2 diabetes and hypertension . Improvement in these comorbidities after surgically-induced weight loss has been documented , and laparoscopic adjustable gastric b and ing ( LAGB ) is an effective weight loss operation . Methods : Of 840 patients who underwent Lap-B and ® , data are available in 402 out of 413 patients whose surgery took place at ≥ 1 year ago . Preoperative and follow-up data were studied retrospectively to examine the effect of Lap-B and ® -induced weight loss on diabetes and hypertension . Results : Of 413 patients with at least 1 year postoperative follow-up , 53 ( 12.8 % ) were taking medications for type 2 diabetes preoperatively and 189 ( 45.7 % ) were on antihypertensive medications . 66 % ( n=35 ) of diabetic patients were also hypertensive . Resolution of diabetes was observed in 66 % at 1-year and 80 % at 2-year follow-up . HbA1c dropped from 7.25 % ( 5.6 - 11.0 , n=53 ) preoperatively to 5.58 % ( 5.0 - 6.2 , n=15 ) at 2 years after surgery . Hypertension resolved in 59.8 % and 74 % at 1 and 2 years , respectively . Percent excess weight loss ( % EWL ) was lower for diabetic patients than for our cohort population ( 39.2 % vs 41.2 % at 1 year , 46.7 % vs 54.2 % at 18 months , and 52.6 % vs 63.3 % at 2 years , respectively ) . Patients in whom diabetes was improved but not resolved had lower % EWL than did those whose diabetes went into remission ( 27.0 % at 1 year and 26.5 % at 2 years ) . Patients with the shortest duration of diabetes ( better weight loss after surgery achieved higher resolution rates . Conclusions : Dramatic improvement in – and frequent resolution of – diabetes and hypertension have been observed as a result of weight loss after Lap-B and ® surgery",
"Background : Different changes of plasma ghrelin levels have been reported following gastric b and ing , Roux-en-Y gastric bypass , and biliopancreatic diversion . Methods : This prospect i ve study compares plasma ghrelin levels and weight loss following laparoscopic sleeve gastrectomy ( LSG ) and laparoscopic adjustable gastric b and ing ( LAGB ) in 20 patients . Results : Patients who underwent LSG ( n=10 ) showed a significant decrease of plasma ghrelin at day 1 compared to preoperative values ( 35.8 ± 12.3 fmol/ml vs 109.6 ± 32.6 fmol/ml , P=0.005 ) . Plasma ghrelin remained low and stable at 1 and 6 months postoperatively . In contrast , no change of plasma ghrelin at day 1 ( 71.8 ± 35.3 fmol/ml vs 73.7 ± 24.8 fmol/ml , P=0.441 ) was found in patients after LAGB ( n=10 ) . Increased plasma ghrelin levels compared with the preoperative levels at 1 ( 101.9 ± 30.3 fmol/ml vs 73.7 ± 24.8 fmol/ml , P=0.028 ) and 6 months ( 104.9 ± 51.1 fmol/ml vs 73.7 ± 24.8 fmol/ml , P=0.012 ) after surgery were observed . Mean excess weight loss was higher in the LSG group at 1 ( 30 ± 13 % vs 17 ± 7 % , P=0.005 ) and 6 months ( 61 ± 16 % vs 29 ± 11 % , P=0.001 ) compared with the LAGB group . Conclusions : As a consequence of resection of the gastric fundus , the predominant area of human ghrelin production , ghrelin is significantly reduced after LSG but not after LAGB . This reduction remains stable at follow-up 6 months postoperatively , which may contribute to the superior weight loss when compared with LAGB ",
"CONTEXT Obesity and diabetes are increasing in the United States . OBJECTIVE To estimate the prevalence of obesity and diabetes among US adults in 2001 . DESIGN , SETTING , AND PARTICIPANTS R and om-digit telephone survey of 195 005 adults aged 18 years or older residing in all states participating in the Behavioral Risk Factor Surveillance System in 2001 . MAIN OUTCOME MEASURES Body mass index , based on self-reported weight and height and self-reported diabetes . RESULTS In 2001 the prevalence of obesity ( BMI > or = 30 ) was 20.9 % vs 19.8 % in 2000 , an increase of 5.6 % . The prevalence of diabetes increased to 7.9 % vs 7.3 % in 2000 , an increase of 8.2 % . The prevalence of BMI of 40 or higher in 2001 was 2.3 % . Overweight and obesity were significantly associated with diabetes , high blood pressure , high cholesterol , asthma , arthritis , and poor health status . Compared with adults with normal weight , adults with a BMI of 40 or higher had an odds ratio ( OR ) of 7.37 ( 95 % confidence interval [ CI ] , 6.39 - 8.50 ) for diagnosed diabetes , 6.38 ( 95 % CI , 5.67 - 7.17 ) for high blood pressure , 1.88 ( 95 % CI,1.67 - 2.13 ) for high cholesterol levels , 2.72 ( 95 % CI , 2.38 - 3.12 ) for asthma , 4.41 ( 95 % CI , 3.91 - 4.97 ) for arthritis , and 4.19 ( 95 % CI , 3.68 - 4.76 ) for fair or poor health . CONCLUSIONS Increases in obesity and diabetes among US adults continue in both sexes , all ages , all races , all educational levels , and all smoking levels . Obesity is strongly associated with several major health risk factors",
"BACKGROUND Obesity and its related comorbid illnesses have become a national health priority . We report comorbidity and quality of life ( QoL ) data after weight loss with gastric b and ing using the Swedish Adjustable Gastric B and ( SAGB ) . METHODS Data were collected prospect ively for 838 consecutive morbidly obese patients who underwent laparoscopic adjustable gastric b and ing ( LAGB ) between January 2001 and July 2007 . Patients were followed-up by a multidisciplinary team consisting of a surgeon , physician , dietician , and exercise consultant , all of whom were involved in the evaluation of clinical outcomes . Continuous data were reported as mean + /- SD ; categorical data were reported as number and percentage . Patients served as their own controls . RESULTS Respective preoperative mean age , weight , and body mass index ( BMI ) were 44 years ( range 16 - 76 ) , 122 kg ( range 86 - 240 ) , and 44 kg/m2 ( range 35 - 86 ) , respectively . SAGB implantation was accomplished by the pars flaccida technique with no conversion to an open procedure . Mature follow-up data were available for 35 % of patients at 24 months and 21 % at 36 months . In the total cohort of 838 patients , BMI ( mean + /- SD ) decreased to 32 + /- 5 kg/m2 and 32 + /- 7 kg/m2 at 24 months and 36 months , respectively . Percentage excess weight loss ( % EWL ) ( mean + /- SD ) was 32 % + /- 14 % ( n = 506 ) , 47 % + /- 15 % ( n = 461 ) , 52 % + /- 16 % ( n = 291 ) , and 54 % + /- 23 % ( n = 175 ) at 6 , 12 , 24 , and 36 months , respectively ( P 545 patients identified with comorbid illness at > 6-month follow-up . After a median follow-up of 13 months ( range 6 - 36 months ) , resolution and /or improvement of comorbidities was as follows : type 2 diabetes mellitus , 79 % ; metabolic syndrome , 78 % ; hypertension , 67 % ; dyslipidemia , 66 % ; gastroesophageal reflux , 66 % ; asthma , 57 % ; arthritis/joint pain , 70 % ; polycystic ovarian syndrome , 48 % ; and depression , 57 % . There was a significant improvement in QoL ( as measured by the Short Form-36 Health Survey [ SF-36 ] ) , bringing patients ' QoL to a level consistent with that of community norms in all 8 domain scores . Of 342 patients surveyed with the Beck Depression Inventory ( BDI-II ) , a statistically significant improvement in depressive mood was also observed ( P SAGB provides a dramatic reduction in many serious comorbid illnesses as well as improvement in the psychosocial wellbeing of morbidly obese patients",
"OBJECTIVE Bariatric surgery reverses obesity-related comorbidities , including type 2 diabetes mellitus . Several studies have already described differences in anthropometrics and body composition in patients undergoing Roux-en-Y gastric bypass compared with laparoscopic adjustable gastric b and ing , but the role of adipokines in the outcomes after the different types of surgery is not known . Differences in weight loss and reversal of insulin resistance exist between the 2 groups and correlate with changes in adipokines . METHODS Fifteen severely obese women ( mean body mass index [ BMI ] : 46.7 kg/m(2 ) ) underwent 2 types of laparoscopic weight loss surgery ( Roux-en-Y gastric bypass=10 , adjustable gastric b and ing=5 ) . Weight , waist and hip circumference , body composition , plasma metabolic markers , and lipids were measured at set intervals during a 24-month period after surgery . RESULTS At 24 months , patients who underwent Roux-en-Y were overweight ( BMI 29.7 kg/m(2 ) ) , whereas patients who underwent gastric b and ing remained obese ( BMI 36.3 kg/m(2 ) ) . Patients who underwent Roux-en-Y lost significantly more fat mass than patients who underwent gastric b and ing ( mean difference 16.8 kg , P leptin levels were lower in the patients who underwent Roux-en-Y ( P=.003 ) , and levels correlated with weight loss , loss of fat mass , insulin levels , and Homeostasis Model of Assessment 2 . Adiponectin correlated with insulin levels and Homeostasis Model of Assessment 2 ( r=-0.653 , P=.04 and r=-0.674 , P=.032 , respectively ) in the patients who underwent Roux-en-Y at 24 months . CONCLUSION After 2 years , weight loss and normalization of metabolic parameters were less pronounced in patients who underwent gastric b and ing compared with patients who underwent Roux-en-Y gastric bypass . Our findings require confirmation in a prospect i ve r and omized trial",
"BACKGROUND Weight loss is associated with short-term amelioration and prevention of metabolic and cardiovascular risk , but whether these benefits persist over time is unknown . METHODS The prospect i ve , controlled Swedish Obese Subjects Study involved obese subjects who underwent gastric surgery and contemporaneously matched , conventionally treated obese control subjects . We now report follow-up data for subjects ( mean age , 48 years ; mean body-mass index , 41 ) who had been enrolled for at least 2 years ( 4047 subjects ) or 10 years ( 1703 subjects ) before the analysis ( January 1 , 2004 ) . The follow-up rate for laboratory examinations was 86.6 percent at 2 years and 74.5 percent at 10 years . RESULTS After two years , the weight had increased by 0.1 percent in the control group and had decreased by 23.4 percent in the surgery group ( P weight had increased by 1.6 percent and decreased by 16.1 percent , respectively ( P Energy intake was lower and the proportion of physically active subjects higher in the surgery group than in the control group throughout the observation period . Two- and 10-year rates of recovery from diabetes , hypertriglyceridemia , low levels of high-density lipoprotein cholesterol , hypertension , and hyperuricemia were more favorable in the surgery group than in the control group , whereas recovery from hypercholesterolemia did not differ between the groups . The surgery group had lower 2- and 10-year incidence rates of diabetes , hypertriglyceridemia , and hyperuricemia than the control group ; differences between the groups in the incidence of hypercholesterolemia and hypertension were undetectable . CONCLUSIONS As compared with conventional therapy , bariatric surgery appears to be a viable option for the treatment of severe obesity , result ing in long-term weight loss , improved lifestyle , and , except for hypercholesterolemia , amelioration in risk factors that were elevated at baseline",
"BACKGROUND To improve decision making in the treatment of extreme obesity , the risks of bariatric surgical procedures require further characterization . METHODS We performed a prospect i ve , multicenter , observational study of 30-day outcomes in consecutive patients undergoing bariatric surgical procedures at 10 clinical sites in the United States from 2005 through 2007 . A composite end point of 30-day major adverse outcomes ( including death ; venous thromboembolism ; percutaneous , endoscopic , or operative reintervention ; and failure to be discharged from the hospital ) was evaluated among patients undergoing first-time bariatric surgery . RESULTS There were 4776 patients who had a first-time bariatric procedure ( mean age , 44.5 years ; 21.1 % men ; 10.9 % nonwhite ; median body-mass index [ the weight in kilograms divided by the square of the height in meters ] , 46.5 ) . More than half had at least two coexisting conditions . A Roux-en-Y gastric bypass was performed in 3412 patients ( with 87.2 % of the procedures performed laparoscopically ) , and laparoscopic adjustable gastric b and ing was performed in 1198 patients ; 166 patients underwent other procedures and were not included in the analysis . The 30-day rate of death among patients who underwent a Roux-en-Y gastric bypass or laparoscopic adjustable gastric b and ing was 0.3 % ; a total of 4.3 % of patients had at least one major adverse outcome . A history of deep-vein thrombosis or pulmonary embolus , a diagnosis of obstructive sleep apnea , and impaired functional status were each independently associated with an increased risk of the composite end point . Extreme values of body-mass index were significantly associated with an increased risk of the composite end point , whereas age , sex , race , ethnic group , and other coexisting conditions were not . CONCLUSIONS The overall risk of death and other adverse outcomes after bariatric surgery was low and varied considerably according to patient characteristics . In helping patients make appropriate choices , short-term safety should be considered in conjunction with both the long-term effects of bariatric surgery and the risks associated with being extremely obese . ( Clinical Trials.gov number , NCT00433810 .",
"Background We hypothesized that laparoscopic adjustable gastric b and ing ( LAGB ) reduces weight and modulates ghrelin production , but largely spares gastrointestinal endocrine function . To examine this hypothesis , we determined plasma concentrations of appetite-control , insulinotropic , and digestive hormones in relation to LAGB . Methods Twenty-four patients undergoing LAGB were prospect ively enrolled . Body mass index ( BMI ) was measured and blood sample s obtained at baseline and 6 and 12 months post-surgery . Plasma concentrations of leptin , acylated and total ghrelin , pancreatic polypeptide ( PP ) , insulin , glucose-dependent insulinotropic peptide ( GIP ) , active glucagon-like peptide-1 ( GLP-1 ) , gastrin , and pepsinogens I and II were measured using enzyme-linked immunoassays . Results Median percent excess weight loss ( % EWL ) over 12 months was 45.7 % with median BMI decreasing from 43.2 at baseline to 33.8 at 12 months post-surgery ( p Median leptin levels decreased from 19.7 ng/ml at baseline to 6.9 ng/ml at 12 months post-surgery ( p plasma levels of acylated and total ghrelin , PP , insulin , GIP , GLP-1 , gastrin , and pepsinogen I did not change in relation to surgery ( p > 0.05 ) . Pepsinogen II levels were significantly lower 6 months after LAGB but returned to baseline levels by 12 months . Conclusions LAGB yielded substantial % EWL and a proportional decrease in plasma leptin . Our results support the hypothesis that LAGB works in part by suppressing the rise in ghrelin that normally accompanies weight loss . Unchanged concentrations of insulinotropic and digestive hormones suggest that gastrointestinal endocrine function is largely maintained in the long term"
] | 41162b08-06ff-11f0-808a-c43d1ab1c353 |
Background Monoblock acetabular components used in uncemented total hip arthroplasty ( THA ) have certain mechanical characteristics that potentially reduce acetabular osteolysis and polyethylene wear . However , the degree to which they achieve this goal is not well documented . Questions / purpose sThe purpose of this study was to use a systematic review of controlled trials to test the hypothesis that monoblock cups have superior ( 1 ) polyethylene wear rate ; ( 2 ) frequency of cup migration ; ( 3 ) frequency of acetabular osteolysis ; and ( 4 ) frequency of aseptic loosening compared with modular components used in uncemented THA . Methods A systematic search was conducted in the Medline , Embase , and Cochrane electronic data bases to assemble all controlled trials comparing monoblock with modular uncemented acetabular components in primary THA . Included studies were considered “ best evidence ” if the quality score was either ≥ 50 % on the Cochrane Back Review Group checklist or ≥ 75 % the Newcastle-Ottawa quality assessment scale . A total of seven publications met our inclusion criteria . Results Best evidence analysis showed no difference in polyethylene wear rate , the frequency of cup migration , and aseptic loosening between monoblock and modular acetabular components . No convincing evidence was found for the cl aim that lower frequencies of acetabular osteolysis are observed with the use of monoblock cups compared with modular uncemented cups . Conclusions The purported benefits of monoblock cups were not substantiated by this systematic review of controlled studies in that polyethylene wear rates and frequencies of cup failure and acetabular osteolysis were similar to those observed with modular implants . Other factors should therefore drive implant selection in cementless THA.Level of Evidence Level III , therapeutic study . See the Guidelines for Authors for a complete description of levels of evidence | [
"In a prospect i ve study , the authors used a porous tantalum monoblock acetabular component for primary total hip arthroplasty between November 1997 and June 1999 . A total of 156 consecutive primary total hip arthroplasty were done in 143 patients younger than 75 years . A total of 151 hips had a follow-up time from 8 to 10 years . The average preoperative total Harris hip score of 44.0 + /- 13.8 increased to 97.0 + /- 6.2 at the latest follow-up . The average preoperative Oxford hip score of 43.3 + /- 6.5 improved to 13.9 + /- 2.3 at the latest follow-up . Radiographic evaluation including the Ein-Bild-Röntgen-Analyse ( EBRA ) digital system showed no radiographic evidence of gross polyethylene wear , progressive radiolucencies , osteolytic lesions , acetabular fracture , or component subsidence . There were 7 ( 4.5 % ) postoperative complications all unrelated to the acetabular component",
"We report a prospect i ve , stratified study of 60 PCA-cups and 60 RM-polyethylene cups which have been followed for a median time of 90 months , with annual radiography . The radiological migration of cups was measured by the computer-assisted EBRA method . A number of threshold migration rates from 1 mm in the first year to 1 mm in five years have been assessed and related to clinical ly determined revision rates . A total of 28 cups showed a total migration of 1 mm or more within the first two years ; 13 of these cups have required revision and been exchanged . The survival curves of cups which had previously shown early migration were considerably different from those without early migration . For cups with a migration of less than 1 mm within the first two years the mean survival at 96 months was 0.96 + /- 0.02 ; for migrating cups , it was 0.63 + /- 0.11 ( log-rank test , p=0.0001 ; chi-square value=39.4 ) . Early migration is a good predictor for late loosening of hip sockets",
"Total hip arthroplasty ( THA ) with well design ed cementless acetabular implants has shown excellent results . The purpose of this study was to assess our clinical and radiological outcomes using an uncemented cup . We conducted a prospect i ve cohort study including all consecutive primary THAs performed with the Morscher press-fit cup , an uncemented non-modular acetabular component , between March 1996 and December 1998 . Patients were evaluated at ten years with clinical and radiological follow-up , patient satisfaction and question naire assessment using the Harris hip score ( HHS ) , Merle d’Aubigné and Postel score , the UCLA score , the 12-item short-form health survey ( SF-12 ) and a visual analog scale . Five hundred sixty-one THAs were performed in 518 patients . At 120 months ( ± 7.3 months ) , 303 patients with 335 THAs were still available for follow-up . None of the patients had required cup revision for aseptic loosening . At ten years , the cup survivorship was 98.8 % ( 95 % CI 97.4–99.5 ) with cup revision for any cause as an endpoint . No radiolucencies were seen around the cups , but osteolytic defects involved 21 stems ( 8.3 % ) . Mean total linear polyethylene wear was 0.9 mm . The Morscher acetabular replacement cup provides excellent results at ten years . There were no revisions for aseptic loosening of the cup , and no osteolytic defects were found around the cup . Patient satisfaction was high and the clinical results were very good",
"Summary Fifty-nine PCA cups and 61 hydroxyapatite-coated RM cups were included in a prospect i ve r and omised study with a mean follow up of 5.2 years . Clinical evaluation revealed better results with the RM cup . Radiological criteria of loosening could be applied only with considerable restrictions as different parameters were assessed : progressively loosened beads in PCA cups and faded contour in RM cups . Migration was measured by a computer assisted method ( EBRA ) . PCA cups showed significantly more longitudinal migration 2 years after operation and subsequently . High migration values correlated with a limp . Loosening as defined by migration was of clinical relevance , could be measured early and predicted the survival rate . RésuméCinquante-neuf cotyles PCA et 61 cotyles RM , recouverts d'hydroxyapatite , ont été rassemblés dans une étude prospect i ve r and omisée . La durée d'observation moyenne est de 5,2 ans . L'évaluation clinique , douleur , mobilité , marche , est en faveur du cotyle RM . Les critères radiologiques d'instabilité sont difficiles à apprécier , d'autant qu'il faut évaluer des paramètres différents : fragments progressivement libérés dans les cotyles PCA et irrégularités des contours dans les cotyles RM . Le déplacement a été étudié selon une nouvelle technique computérisée EBRA . Les cotyles PCA ont présenté une migration appréciable , surtout longitudinale , dès la 2ème année post-opératoire et ultérieurement une migration moyenne de 0,6 mm à 5 ans . Il existe une corrélation entre les déplacements importants et la boiterie . L'instabilité cotyloïdienne définie par le déplacement semble correspondre au résultat clinique , même à un stade précoce",
"Our study reports a sub-group of patients with developmental dysplasia from a previously published larger series , with particular emphasis on the use of the uncemented RM acetabular component . We evaluated the long term results of 93 consecutive uncemented THAs in 80 patients using the titanium-coated RM acetabular component and the CLS femoral component in a prospect i ve study . Eighteen hips in 16 patients had osteoarthritis secondary to developmental dysplasia of the hip . The mean follow-up was 19.6 years ( 18.2 to 20.9 ) . Fourteen patients with 15 hips were clinical ly and radiographically examined and evaluated . Two patients with 3 hips died . No patient was lost to follow-up . No implant had to be revised , and no cases showed evidence of radiographic loosening . Nine acetabular components were not completely covered by host bone but this did not affect the outcome . At the latest follow-up the mean Harris Hip Score was 92 ( 81 to 100 ) . The mean annual wear rate was 0.12 mm . The RM acetabular component performed well over 20 years in this selected group of patients . Complete acetabular containment was not needed , thus allowing reliable reconstruction of the anatomical centre of rotation",
"To evaluate different modes of cementless fixation of hemispherical cups , we operated on 87 hips in 81 patients using 4 different means of cup fixation . The hips were r and omly assigned to fixation with press-fit technique only ( PF ) , or with augmentation with screws ( S ) , pegs ( P ) , or hydroxyapatite ( HA ) coating . The patients were evaluated with radiostereometric analysis ( RSA ) for cup migration and wear , conventional radiography for osteolysis , and Harris Hip Score for clinical outcome over 5 years . The fixation of the cups did not differ between the groups , but HA showed a tendency to decrease proximal migration . HA-coated cups displayed the best interface with hardly any signs of radiolucent lines , indicating a superior sealing effect of the HA coating . Cups with screws or pegs had more radiolucent lines and osteolytic lesions than the other groups . Radiolucent lines were correlated to higher proximal migration , young age , and female gender ( r2=.2 ) . The wear rate of the ethylene oxide-sterilized polyethylene liner was high ( 0.2 mm/y ) but did not differ between the groups . Two cups with a perioperative fracture of the acetabular rim showed large initial migration but stabilized thereafter",
" This study evaluated 185 cementless Mathys coated and uncoated acetabular cups inserted for total hip replacement since September 1984 . All of the cups were high-density polyethylene . Sixty were uncoated ( group A ) , 96 were coated with hydroxyapatite ( group B ) , and 29 were coated with titanium ( group C ) . Cup survival was assessed clinical ly , histologically , and radiographically , and a computer-assisted EBRA method was used to evaluate cup migration . After a mean follow-up of 8 years , five cups in group A that had previously shown migration were revised as a result of aseptic loosening , while no loosening of hip sockets occurred in groups B and C. These results suggest that Mathys cups should be used only if coated with hydroxyapatite or titanium . Furthermore , the histologic evaluation in four cups from groups B and C revealed normal bone formation without inflammation or fibrotic tissue around the cups , promising long-term survival"
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OBJECTIVE To examine the methods used to calculate the reported medication initiation rates in secondary fracture prevention programs . STUDY DESIGN AND SETTING A systematic review was conducted on postfracture interventions that aim ed to improve osteoporosis management in an orthopedic environment . Two authors independently review ed eligible articles to determine the numerator and denominator used to calculate the rates of antiresorptive medication initiation based on author reports . In interventions with numerator and denominator combinations that appeared to be comparable , we examined the inclusion and exclusion criteria to confirm comparability . RESULTS Fifty-seven articles reporting on 64 interventions were eligible for the review . A total of 28 different combinations of numerators and denominators to calculate rates were reported for medication initiation across 49 of the 64 interventions . After examining the inclusion and exclusion criteria for rates that appeared to be comparable , the highest number of interventions with a comparable rate was 3 . CONCLUSION Reporting processes for antiresorptive medication initiation outcomes in secondary fracture prevention programs used heterogeneous st and ards that prevented useful comparison of programs . Applying different numerator and denominator combinations meant that the same observed number of patients could have result ed in different reported rates . We propose st and ards for reporting medication initiation rates in such programs | [
"Developing an evidence base for making public health decisions will require using data from evaluation studies with r and omized and nonr and omized design s. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study , with sufficient detail and clarity to readily see differences and similarities among studies in the same area . The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement provides guidelines for transparent reporting of r and omized clinical trials . We present the initial version of the Transparent Reporting of Evaluations with Nonr and omized Design s ( TREND ) statement . These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions , research design , and methods of adjusting for possible biases in evaluation studies that use nonr and omized design",
"Objectives To establish a protocol for the treatment of fragility fractures in the hospital setting based on treatment of osteoporosis . Material s and methods An intervention protocol was implemented in patients with fragility fractures based on ( 1 ) indicating the diagnosis of osteoporotic fracture in the summary of discharge ; ( 2 ) “ lifestyle recommendations ” ; and ( 3 ) therapy for osteoporosis . Thirty-one hospitals were involved and they were informed of the importance of protocol compliance . In the first phase , a retrospective study was conducted to establish the number of low-energy fractures treated and the percentage of them that had complied with the protocol ( n = 887 ) . Then , prospect ively , the same data were collected for the patients managed for 1 year ( n = 6,826 ) in three sections of 4-month intervals . Results The percentage of compliance increased from 8.2 to 57.2 % in the first point , from 12.6 to 42.4 % in the second , and from 10.3 to 43.2 % in the third . Conclusion The implementation of programs to improve osteoporosis treatment is very useful for ensuring adherence in the management of osteoporosis following admission due to fragility fracture",
"BACKGROUND Although osteoporosis is strongly associated with hip fractures , the initiation of osteoporosis treatment following hip fractures occurs at surprisingly low rates of between 5 % and 30 % . Currently , most patients receiving treatment have been referred back to their primary care physician for osteoporosis management . The purpose of this study was to compare the effect of osteoporosis management initiated by the orthopaedic team and osteoporosis management initiated by the primary care physician on the rates of treatment at six months . METHODS A prospect i ve r and omized trial was conducted to assess the difference in the rate of osteoporosis treatment when an in-house assessment of osteoporosis was initiated by the orthopaedic surgeon and follow-up was conducted in a specialized orthopaedic osteoporosis clinic compared with osteoporosis education and \" usual \" care . RESULTS Sixty-two patients were enrolled in the study . Thirty-one patients each were in the control and intervention groups . The percentage of patients who were on pharmacologic treatment for osteoporosis at six months after the fracture was significantly greater when the evaluation was initiated by the orthopaedic surgeon and was managed in a specialized orthopaedic osteoporosis clinic ( 58 % ) than when treatment was managed by a primary care physician ( 29 % ) ( p = 0.04 ) . CONCLUSIONS An active role by orthopaedic surgeons in the management of osteoporosis improves the rate of treatment at six months following a hip fracture",
"BACKGROUND In a r and omized trial of patients with hip fractures , we previously demonstrated that a hospital-based case manager could increase rates of appropriate osteoporosis treatment to 51 % compared with 22 % for usual care ( P Patients with hip fractures were r and omized to usual care ( n = 110 ) or a case manager ( n = 110 ) and followed up for 1 year . Time-motion studies were used to determine intervention costs . From a third-party health care payer perspective and over the patient 's remaining lifetime , a Markov decision-analytic model was constructed to determine cost-effectiveness of the intervention compared with usual care . Costs and benefits were discounted at 3 % and expressed in 2006 Canadian dollars . RESULTS The intervention cost CaD $ 56 per patient . Compared with usual care , the intervention strategy was dominant : for every 100 patients case managed , 6 fractures ( 4 hip fractures ) were prevented , 4 quality -adjusted life-years were gained , and CaD $ 260 000 was saved by the health care system . Irrespective of the number of patients case managed , the intervention reached a break-even threshold within 2 years . The intervention dominated usual care over the entire spectrum of 1-way sensitivity analyses and was cost-saving in 82 % of probabilistic model simulations . CONCLUSIONS Compared with usual care , we found that using a case manager for patients with hip fractures increased rates of appropriate osteoporosis treatment . The intervention dominated usual care , and the analysis suggests that systems implementing an intervention similar to ours should expect to see a reduction in fractures , gains in life expectancy , and substantial cost savings . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00175175",
"Background : Osteoporosis is a common disease characterized by decreased bone mass and increased fracture risk in postmenopausal women and the elderly . Hip fractures are among the most common consequences of osteoporosis and unfortunately usually occur late in the course of the disease . When a patient is admitted to the hospital with a fragility hip fracture , a unique opportunity for diagnosis and treatment presents itself . Fortunately , several medications have proven to be effective in lowering the risk of future fractures . The purpose s of the present study were to test the hypothesis that most fragility hip fractures go untreated and to determine whether educational efforts to raise physician awareness have led to an improvement in osteoporosis treatment rates . Methods : A retrospective cohort study was performed with use of the patient data bases at two university medical centers and one university-affiliated community hospital . The charts of 300 r and omly selected patients were sorted with use of ICD-9 ( International Classification of Diseases , Ninth Revision ) codes for femoral neck fractures . There were 100 patients from each center , with twenty-five patients from each year between 1997 and 2000 . The admitting diagnosis , mechanism of injury , admission medications , procedures performed during hospitalization , and discharge medications were then extracted and analyzed . During this period , the National Osteoporosis Foundation established guiding principles for the treatment of fragility fractures . Results : Of the seventy-five patients from all centers for each year from 1997 to 2000 , 11 % , 13 % , 24 % , and 29 % , respectively , were discharged with a prescription for some medication targeting osteopenia , either supplemental calcium or an antiosteoporotic medication ( estrogen , calcitonin , a bisphosphonate , or raloxifene ) . A trended chi-square analysis of this increase revealed a p value of prescription at the time of discharge . However , forty of these patients ( 13.3 % of the overall group ) received calcium and only eighteen ( 6.0 % of the overall group ) received a medication to actively prevent bone resorption and treat osteoporosis . In addition , no patient underwent a bone density scan while in the hospital . Conclusions : Elderly patients and postmenopausal women who are admitted to the hospital and diagnosed with a low-energy femoral neck fracture have been undertreated for osteoporosis . However , over the four years of the present study , there was a significant increase in the rate of treatment . It is hoped that treatment rates will continue to increase in the future with continued educational efforts",
"Background : Missed opportunities for osteoporosis detection and treatment following fractures , especially in the elderly , are common . Clinical pharmacy specialist ( CPS ) intervention may positively impact this deficiency . Objective : To examine the impact of a CPS-managed intervention to identify , screen , and initiate appropriate osteoporosis pharmacotherapy in elderly patients after an atraumatic fracture . Methods : This was a prospect i ve quality improvement analysis . Hospitalized and ambulatory patients who had a diagnosis of atraumatic fracture between July 2002 through August 2003 but were not on osteoporosis pharmacotherapy were identified by CPSs . Bone mineral density ( BMD ) screening and osteoporosis pharmacotherapy recommendations were made by a CPS when appropriate . Descriptive analyses were performed to determine the proportion of patients initiated on osteoporosis pharmacotherapy or receiving a recommended BMD evaluation . Results : A total of 137 ( 40 inpatient and 97 ambulatory ) female patients were included . The mean ages ± SD of inpatient and ambulatory patients were 83 ± 8 and 70 ± 7 years , respectively . Overall , 50 % ( n = 69 ) of patients either initiated their recommended osteoporosis pharmacotherapy ( 48 % [ n = 19 ] and 30 % [ n = 29 ] of inpatient and ambulatory patients , respectively ) or received a recommended BMD screening ( 42 ambulatory patients were recommended and 50 % [ n = 21 ] completed a BMD test ) . Of the patients who completed a BMD test , 17 ( 81 % ) were osteoporotic . All 17 were initiated on osteoporosis pharmacotherapy . Conclusions : Using a systematic approach to identify patients in need of osteoporosis pharmacotherapy , a CPS-managed intervention result ed in clinical ly meaningful osteoporosis treatment initiation rates ",
"Observational longitudinal research is particularly useful for assessing etiology and prognosis and for providing evidence for clinical decision making . However , there are no structured reporting requirements for studies of this design to assist authors , editors , and readers . The authors developed and tested a checklist of criteria related to threats to the internal and external validity of observational longitudinal studies . The checklist criteria concerned recruitment , data collection , biases , and data analysis and descriptive issues relevant to study rationale , study population , and generalizability . Two raters independently assessed 49 r and omly selected articles describing stroke research published from 1999 to 2003 in six journals : American Journal of Epidemiology , Journal of Epidemiology and Community Health , Stroke , Annals of Neurology , Archives of Physical Medicine and Rehabilitation , and American Journal of Physical Medicine and Rehabilitation . On average , 17 of the 33 checklist criteria were reported . Criteria describing the study design were better reported than those related to internal validity . No relation was found between study type ( etiologic or prognostic ) or word count and quality of reporting . A flow diagram for summarizing participant flow through a study was developed . Editors and authors should consider using a checklist and flow diagram when reporting on observational longitudinal research",
"Introduction Older patients with fragility fractures are not commonly tested or treated for osteoporosis . Compared to usual care , a previously reported intervention led to 30 % absolute increases in osteoporosis treatment within 6 months of wrist fracture . Our objective was to examine longer-term outcomes , reproducibility , and cost-effectiveness of this intervention . Methods We conducted an extended analysis of a non-r and omized controlled trial with blinded ascertainment of outcomes that compared a multifaceted intervention to usual care controls . Patients > 50 years with a wrist fracture treated in two Emergency Departments in the province of Alberta , Canada were included ; those already treated for osteoporosis were excluded . Overall , 102 patients participated in this study ( 55 intervention and 47 controls ; median age : 66 years ; 78 % were women ) . The interventions consisted of faxed physician reminders that contained osteoporosis treatment guidelines endorsed by opinion leaders and patient counseling . Controls received usual care ; at 6-months post-fracture , when the original trial was completed , all controls were crossed-over to intervention . The main outcomes were rates of osteoporosis testing and treatment within 6 months ( original study ) and 1 year ( delayed intervention ) of fracture , and 1-year persistence with treatments started . From the perspective of the healthcare payer , the cost-effectiveness ( using a Markov decision-analytic model ) of the intervention was compared with usual care over a lifetime horizon . Results Overall , 40 % of the intervention patients ( vs. 10 % of the controls ) started treatment within 6 months post-fracture , and 82 % ( 95%CI : 67–96 % ) had persisted with it at 1-year post-fracture . Delaying the intervention to controls for 6 months still led to equivalent rates of bone mineral density ( BMD ) testing ( 64 vs. 60 % in the original study ; p = 0.72 ) and osteoporosis treatment ( 43 vs. 40 % ; p = 0.77 ) as previously reported . Compared with usual care , the intervention strategy was dominant – per patient , it led to a $ 13 Canadian ( U.S. $ 9 ) cost savings and a gain of 0.012 quality -adjusted life years . Base-case results were most sensitive to assumptions about treatment cost ; for example , a 50 % increase in the price of osteoporosis medication led to an incremental cost-effectiveness ratio of $ 24,250 Canadian ( U.S. $ 17,218 ) per quality -adjusted life year gained . Conclusions A pragmatic intervention directed at patients and physicians led to substantial improvements in osteoporosis treatment , even when delivered 6-months post-fracture . From the healthcare payer ’s perspective , the intervention appears to have led to both cost-savings and gains in life expectancy",
"In an attempt to identify a high-risk cohort of patients , who could be offered preventive therapy , we assessed patients who had suffered one hip fracture . A total of 394 patients were prospect ively followed to determine those who had suffered a second fracture . Entry bone mass of the unfractured hip and total body was examined by dual X-ray absorptiometry ( DXA ) and of the os calcis , by quantitative ultrasound ( QUS ) , along with various clinical parameters . The relative risks in the QUS parameters did not reach significance , except for broadb and ultrasound attentuation as measured by the McCue CUBA Clinical , whereas femoral neck and total body bone mineral density also reached significance . Lowest quartile body weight was also a significant risk factor as were occurrence of a new fall and poor mobility score . Using Receiver Operator Characteristic curves , we found no significant differences between DXA trochanter or for the Mini Mental State Examination score in predicting those who sustained a second hip fracture . In this elderly group risk factors are almost as good as bone mass at predicting those who will sustain a second hip fracture . Low body weight and poor mobility could be used as triggers for the use of preventive therapy without the use of bone mass measurements and to target expensive preventive therapy to reduce fracture risk",
"OBJECTIVE To review the 3-year performance of an established osteoporosis care service and consider further improvements in an effort to reduce fragility fractures . METHODS Osteoporosis care has been coordinated for all willing and able patients with orthopedic fragility fractures in our health system by a nurse and medical director since 2003 , using a guideline -based care algorithm and task management software . Patients were followed by telephone for 2 years to monitor their status and optimize adherence to treatment . Demographics , management recommendations , clinical data , and adherence to treatment were review ed for the 2003 - 2005 patient population . RESULTS Of 1,019 patients with fragility fractures , 61 % underwent osteoporosis evaluation and treatment . The remainder included 15 % who refused to participate and 24 % who were unable to participate for various logistical and health reasons . More patients age > 80 years were unwilling or unable to participate . Bone densities ( dual x-ray absorptiometry [ DXA ] ) were normal , low , or osteoporotic in 24 % , 55 % , and 21 % of patients , respectively , and 60 % of the osteoporotic group had > or = 1 abnormal metabolic bone laboratory result . Only 17 % of the total reported a previous fracture , and 47 % had ever undergone DXA . Few experienced bone loss , a new fracture , or bisphosphonate intolerance during treatment . CONCLUSION An osteoporosis care service has coordinated care for every willing and able fragility fracture patient with positive outcomes . In addition , the results suggest a high priority for earlier proactive diagnosis and intervention of the at-risk population if fractures are to be reduced",
"This study compares the investigation of and treatment for osteoporosis in two groups of fracture patients at two orthopaedic centres in the UK . One centre had a formal fracture liaison service ( FLS ) responsible for screening fracture patients for osteoporosis . The other centre relied upon individual clinicians to initiate investigation or treatment for osteoporosis in patients following fracture . Patients who had been treated in either centre for a proximal humeral or hip fracture during a 6-month period were followed up 6 months later to identify how many had received screening or treatment for osteoporosis . Information was retrieved from a prospect ively compiled data base or by postal question naire . The study revealed that in the centre with an FLS 85 % of patients with a proximal humeral fracture and 20 % with a hip fracture had been offered a dual-energy X-ray absorptiometry ( DEXA ) scan . Approximately 50 % and 85 % , respectively , were receiving treatment for osteoporosis 6 months following their fracture . This compared with DEXA being offered to only 6 % and 9.7 % of humeral and hip fracture patients , respectively , and 20 % ( hip ) and 27 % ( proximal humerus ) receiving osteoporosis treatment in the other centre . The presence of an FLS result ed in a considerably higher proportion of patients receiving investigation and treatment for osteoporosis following a hip or proximal humeral fracture",
"UNLABELLED A low-impact fracture in a postmenopausal woman should prompt investigations for osteoporosis followed , if needed , by appropriate treatment . OBJECTIVES To evaluate the impact of information alerting general practitioners to the need for osteoporosis treatment in postmenopausal women with a recent history of peripheral fracture . METHODS We conducted a prospect i ve 7-month follow-up study of 78 postmenopausal women , with a mean age of 81.5 years , admitted to the emergency department for peripheral fractures . Three months after the fracture , we sent a letter to the general practitioner of each patient emphasizing the probable contribution of osteoporosis to the fracture and the need for osteoporosis treatment . Six months after the fracture , we interviewed the patients by telephone , and one month later we mailed a question naire to those physicians who had not followed the treatment recommendation . RESULTS At emergency room admission , 9 patients were receiving treatment for osteoporosis ( hormone replacement therapy in one patient and calcium and vitamin D supplementation in eight patients ) . Admission to a ward was required in 66 ( 85 % ) patients . No treatment for osteoporosis was given at discharge . Six months after discharge , seven patients reported recent initiation of calcium and vitamin D supplementation , and none reported other osteoporosis treatments . The response rate to the physician question naire mailed 7 months after discharge was 54 % ( n=28 ) ; responses showed treatment of 11 additional patients , by calcium and vitamin D supplementation in six cases and by bisphosphonates with or without calcium and vitamin D supplementation in five cases . Treatment initiation rates were similar in patients younger and older than 80 years . CONCLUSIONS Despite information of general practitioners about the need for osteoporosis treatment , such treatment was initiated in only 30.5 % of patients . General practitioners may be reluctant to initiate osteoporosis treatment in patients who are very old or have multiple comorbidities",
"OBJECTIVES Osteoporosis treatment rates after a fracture are low . This study evaluated methods to increase guideline -recommended osteoporosis care postfracture . DESIGN Participants were r and omly assigned to usual care or one of two interventions . Analysis of primary outcomes used electronic data and linear regression . SETTING A Pacific Northwest nonprofit health maintenance organization . PARTICIPANTS Female patients aged 50 to 89 who suffered a fracture in 1999 and had not received bone mineral density ( BMD ) measurement or medication for osteoporosis ( n=311 ) and their primary care providers ( n=159 ) . INTERVENTION Patient-specific clinical guideline advice to the primary care provider delivered by electronic medical record ( EMR ) message or electronic reminder to the provider plus an educational letter mailed to the patient . MEASUREMENTS BMD measurement and osteoporosis medication . RESULTS At 6 months , provider reminder result ed in 51.5 % of patients receiving BMD measurement or osteoporosis medication , provider reminder plus patient education result ed in 43.1 % , and usual care result ed in 5.9 % ( P Patients aged 60 to 69 were 18 % ( 95 % confidence interval=3 - 34 ) more likely to receive BMD measurement or an osteoporosis medication than those aged 80 to 89 . CONCLUSION Patient-specific postfracture advice to the provider through an EMR message significantly increased BMD measurement and osteoporosis medication . As EMRs become more widespread , this intervention could improve osteoporosis management for many postfracture patients . Future research should identify barriers to and facilitators of care for older , high-risk patients",
"Introduction Despite the high risk for subsequent fracture following an initial osteoporotic fracture , the majority of subjects with minimal trauma fractures receive no treatment for osteoporosis . The primary aim of this investigation was to determine whether an information-based intervention could change post-fracture management of osteoporosis . A secondary aim was to define participant- and doctor-related barriers to osteoporosis management . Methods Consecutive fracture patients ( n=254 ) from the outpatient fracture clinic at St Vincent ’s Hospital , Sydney were interviewed over a 15-month period ( February 2002–July 2003 ) . Fracture risk factors , prior investigation and treatment for osteoporosis were collected at baseline . Participants were initially contacted after 3 months to ascertain follow-up management . All those not investigated or treated by their primary care physician were then r and omized to either a personalized letter or the same letter plus an offer of a free bone mineral density ( BMD ) test . Participants were contacted after 9 months to record further investigations or treatment for osteoporosis . Results Less than 20 % of the participants had a primary care physician follow-up 3 months after the fracture , leaving 159 who were r and omized to a personalized letter ( n=79 ) and a personalized letter plus the offer of a free BMD test ( n=80 ) . There was a significant increase in the number of people investigated for osteoporosis in the group receiving the letter plus BMD offer [ 38 % ( letter + BMD ) vs. 7 % ( letter only ) ; p=0.001 ) . A high proportion of those tested had low BMD ( 49 % osteopenia and 17 % osteoporosis ) . However , the rates of treatment in both groups were very low ( 6 % ) . Furthermore , even among the few individuals ( 23 % ) who contacted their primary care physician , only 25 % were recommended treatment . The belief that the fracture was osteoporotic was an independent predictor of having a BMD test , a primary care physician follow-up and treatment . Other independent predictors were age over 50 years for a primary care physician follow-up , female sex for having a BMD test and having had a BMD test for treatment . Conclusion This study demonstrates that an information-based intervention led to a modest increase in the proportion of people investigated for osteoporosis ; however . there was no significant effect on treatment rates . The offer of a free BMD assessment was associated with a significantly higher rate of investigation than a personalized letter alone ( odds ratio : 8.5 ; 95 % confidence interval : 3.1–24.5 ) , but this investigation did not affect treatment rate . The low uptake of either a BMD or a visit to a primary care physician together with low rates of treatment recommendation even among people who contacted their primary care physician reflects significant participant and doctor-related barriers to osteoporosis management",
"OBJECTIVE We aim ed to determine whether a novel Patient Empowerment and Physician Alerting ( PEPA ) intervention would improve the proportion of seniors who were investigated and treated for osteoporosis after hip fracture . METHODS We undertook a 6-month r and omized controlled trial ( RCT ) in 48 women and men > /= 60 years old who had suffered a hip fracture and were admitted to a tertiary-care university hospital . The primary outcome measure was the proportion of participants offered one or more osteoporosis-specific ' best practice s ' measured using the Diagnosis and Management Question naire ( DMQ ) . Participant responses were vali date d in part by physician report . RESULTS In the PEPA intervention group , 19 ( 68 % ) were offered one or more components of best practice care compared with 7 ( 35 % ) in the ' usual care ' group ( p PEPA group , 15 ( 54 % ) ( p bisphosphonate therapy , 8 ( 29 % ) ( p bone mineral density scan , 11 ( 39 % ) were prescribed calcium and vitamin D ( p = .32 ) , and 9 ( 32 % ) ( p exercise . In the usual care group , 0 ( 0 % ) were prescribed bisphosphonate therapy , a bone mineral density assessment , or exercise and 6 ( 30 % ) were prescribed calcium and vitamin D. CONCLUSIONS This simple , inexpensive PEPA intervention result ed in far superior clinical management than did usual care in a population at high risk of future hip fracture",
"PURPOSE To evaluate the quality of reporting in the neovascular age-related macular degeneration ( nvAMD ) literature by applying the Consoli date d St and ards for Reporting Trials ( CONSORT ) and Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) statement writing st and ards . DESIGN CONSORT and STROBE impact analysis ; literature review . PARTICIPANTS Phase III r and omized controlled trials ( RCTs ) of verteporfin photodynamic therapy , pegaptanib , and ranibizumab , and interventional case studies of bevacizumab for nvAMD . METHODS A literature search identified eligible articles published before October 31 , 2007 . We assessed the report quality of Phase III RCTs using the CONSORT statement and case series publications using the STROBE statement , both with indicators relevant to nvAMD . MAIN OUTCOME MEASURES Presence or absence of CONSORT or STROBE statement indicators . RESULTS Seven publications of Phase III RCTs and 29 publications on bevacizumab interventional case studies for nvAMD met our inclusion criteria . Of 37 possible CONSORT writing guideline items , the mean report quality for RCTs was 30.6 ( 83 % ) , with a range from 23 to 35 ( 65%-95 % ) . Of 35 possible STROBE writing guideline items , the mean report quality grade for intravitreal bevacizumab case series was 23 ( 70 % ) , with a range from 16 to 31 ( 46%-94 % ) . Among the bevacizumab studies , more than 90 % reported scientific background , drug dose and administration , baseline characteristics , unadjusted results , and adverse events . Fewer than 20 % reported study size calculations , h and ling of missing data , or a discussion of bias . CONCLUSIONS Since the adoption of the CONSORT st and ards by Ophthalmology and other journals in 1996 , the reporting quality for RCTs has further improved among this cohort of nvAMD articles . On the other h and , no reporting st and ards for case series have existed until the recent publication of the STROBE statement . In this first application of the STROBE st and ards to ophthalmology , we found that the small interventional studies in our series had an average reporting score lower than the RCTs , but also that some individual scores were higher than the RCTs . This outcome demonstrates that good , useful articles can be written about small studies . Although not a direct measure of the quality of a study , good reporting allows a reader to assess the validity and applicability of the study 's findings . FINANCIAL DISCLOSURE(S ) Proprietary or commercial disclosure may be found after the references",
"Context Many patients who sustain fragility fractures do not receive subsequent testing and treatment for osteoporosis . Contribution This study shows that faxed reminders to physicians , treatment guidelines endorsed by opinion leaders , and patient education about osteoporosis can increase the testing and therapy for osteoporosis among patients who present to an emergency department with wrist fracture . Caution s This study did not r and omly assign persons to the intervention group and did not examine improvements in bone density or repeated fractures . The Editors Osteoporosis , a chronic and progressive condition that leads to decreased bone mass and skeletal fragility , may result in fractures , disability , pain , deformity , and even death ( 1 - 3 ) . The condition is common , affecting an estimated 1.4 million Canadians and 10 million Americans ( 1 , 2 ) . These figures represent 25 % of women and 12 % of men older than 50 years of age ( 1 , 2 ) . In the United States , the annual cost of treating osteoporosis and its sequelae has been estimated at $ 13.8 billion ( 2 ) , compared with $ 7.5 billion for congestive heart failure and $ 6.2 billion for asthma ( 3 ) . Without better preventive strategies , the rate of osteoporotic fractures is expected to double over the next 15 years ( 4 ) . Several experts ( 5 ) and guidelines ( 1 , 2 ) suggest a preventive strategy of identifying people with typical osteoporosis-related fractures ( for example , fractures of the hip , spine , or wrist [ often called fragility fractures ] ) and targeting them for treatment . They recommend this strategy because this population is at the greatest risk for subsequent fracture and may derive the greatest absolute benefit from treatment . Numerous safe and effective treatments can reduce the risk for recurrent fracture by 40 % to 60 % ( 1 - 3 , 6 ) . In addition , with the use of bisphosphonates and raloxifene , all subgroups of examined patients may obtain beneficial effects ( 3 , 7 - 9 ) within a year ( 7 , 8) . People 50 years of age and older with a fracture of the wrist may be particularly well suited to a strategy of case finding and secondary prevention . Fractures of the wrist are the most common symptomatic fracture related to osteoporosis ( 3 ) , and 70 % to 80 % of persons with wrist fractures have low bone mass ( 10 , 11 ) . Observational studies suggest that a wrist fracture is a sentinel event in the natural history of osteoporosis because this type of fracture forecasts an increased risk for fractures of the hip and spine over the next 10 to 20 years ( 12 - 14 ) . Best practice ( clinical practice consistent with current evidence and expert consensus ) would be to identify people 50 years of age or older with a fragility fracture of the wrist , to measure their bone mineral density , and to treat those with low bone mass or osteoporosis ( 1 , 2 , 5 ) . However , the gap between best practice and everyday clinical practice is wide . Over the past 5 to 10 years , studies from the United States ( 3 , 15 , 16 ) , Canada ( 17 , 18 ) , and elsewhere ( 5 , 19 ) report that rates of testing for and treating osteoporosis a year or longer after a fracture of the wrist are less than 10 % to 20 % . This is an important failure in the process of knowledge translation and indicates that benefits within our reach are not being achieved . We design ed a pragmatic , multifaceted osteoporosis intervention strategy directed at people 50 years of age or older with a fracture of the wrist and at their primary care physicians . The intervention consisted of physician reminders , treatment guidelines endorsed by local opinion leaders , and patient education . Our primary objective was to examine whether this intervention improved the diagnosis and treatment of osteoporosis in this high-risk population . Secondary objectives included examining the effect of this intervention on patients ' knowledge , satisfaction , and quality of life . Methods Setting and Participants Capital Health ( Edmonton , Alberta ) is one of the largest integrated health service delivery organizations in Canada ( 20 ) . It provides comprehensive health services for about 1 million people and has an annual budget of almost $ 2 billion ( Canadian ) ( 20 ) . Primary care is delivered by approximately 900 fee-for-service physicians . We enrolled participants from the 2 largest emergency departments in the region : the University of Alberta Hospital ( a university-based teaching hospital ) and the Royal Alex and ra Hospital ( a university-affiliated community teaching hospital ) . These emergency departments provide most of the fracture care and emergency orthopedic services to the region . Consecutive patients presenting to the emergency department with a wrist fracture were potentially eligible . Inclusion criteria were as follows : age 50 years or older ; any simple , closed fracture of the distal forearm ; and discharge home . We excluded patients who were already taking prescription treatments for osteoporosis . Because we did not ask patients whether they had a diagnosis of osteoporosis until study closeout , a patient with a history of osteoporosis who was not being treated with prescription medication was potentially eligible for inclusion . We also excluded patients who were unable to provide consent , were unwilling to participate , were admitted to the hospital , resided in a long-term care facility , resided outside the Capital Health region , or could not read and converse in English . Study Design and Patient Enrollment We conducted a prospect i ve controlled trial with blinded ascertainment of outcomes . To allocate patients to the intervention or usual care control groups , we adapted and modified an onoff 1-site study design for 2 sites ( 21 ) . For 1 month at a time , in sequential order , the intervention was on at 1 emergency department while it was off at the other . At the end of each month , research nurses alternated intervention status from on to off or vice versa . Patients with wrist fractures were treated , as appropriate , by emergency department physicians and then approached by research nurses or orthopedic technicians for enrollment in the study before discharge home . We obtained informed consent from each patient , and all data were maintained outside the emergency departments in a central ized secure file system . The University of Alberta Health Research Ethics Board approved the study . Intervention We design ed an intervention to overcome the many barriers that exist for primary care physicians who are trying to adopt evidence -based treatments for their patients with osteoporosis . Each of the 3 components of the intervention had published evidence of effectiveness ( 22 - 24 ) . Physician Reminders A reminder was generated for each patient and faxed to the primary care physician of record . The reminder notified physicians that their patient had recently been seen and treated in the emergency department for a wrist fracture and reminded them that their patient was now considered to be at increased risk for osteoporosis . Generating and sending the personalized and patient-specific reminder took about 6 minutes for each patient . Treatment Guidelines Generated and Endorsed by Opinion Leaders As part of the reminder , we provided brief evidence -based treatment recommendations . These guidelines were design ed to fit on the same page and emphasized 3 points : 1 ) The patient is at very high risk for osteoporosis and needs a bone mineral density measurement if one has not been performed in the past year ; 2 ) without treatment , the patient may be at increased risk for another fracture within the year ; and 3 ) bisphosphonate treatment will reduce the patient 's risk for fracture by about 50 % . Bisphosphonate alternatives ( for example , calcitonin , raloxifene , and hormone therapy ) were mentioned as second-line approved treatments because , at the time of study design , only the bisphosphonates had been demonstrated to prevent both vertebral and nonvertebral fractures . Using previously vali date d methods ( 25 , 26 ) , we recruited 5 osteoporosis opinion leaders who had been nominated by local primary care providers . The opinion leaders helped develop and then endorsed the guidelines by attaching their names and signatures . Patient Education We provided patients in the intervention group with a tailored , single-page summary of osteoporosis information that mirrored the physician material s described in the preceding paragraph . We reinforced these written material s with a brief telephone counseling session that took place within 1 week of the fracture . This counseling ( approximately 4 minutes per session ) reiterated the content of the written material s and encouraged patients to seek further information and counseling from their primary care physician . We did not provide intervention patients with any written material s or counseling regarding fall prevention or home safety . Control Patients ( Usual Care ) On the basis of surveys and in-depth interviews with emergency department physicians in Canada and the United States , the current st and ard of care for patients treated for a wrist fracture usually consists of 1 ) notification to the primary care physician of record that the patient was seen and treated and 2 ) information on follow-up plans . We ensured that such notifications occurred for all control patients . In addition , we enhanced usual care by ensuring that control patients received educational material s and telephone counseling regarding fall prevention and home safety . During the call , patients were encouraged to visit their primary care physician for more detailed advice and a medication review . They did not receive any counseling or educational material s about osteoporosis . Thus , control patients received the same amount of attention and care as the intervention patients . After the main study was completed , all control patients were crossed over to the osteoporosis intervention , and all intervention patients were provided with counseling regarding fall prevention and home safety . Outcomes and Measurements The primary study outcome was",
"BACKGROUND Treatment of osteoporosis following a hip fracture has been notoriously poor . Many efforts have been made to improve treatment rates . The purpose of this study was to determine whether a perioperative inpatient intervention program , involving patient education and providing a list of questions for the primary care physician , increased the percentage of patients in whom osteoporosis was addressed following a hip fracture . METHODS A prospect i ve , r and omized trial involving eighty patients who had been admitted to an academic medical center with a low-energy hip fracture was conducted . During their hospitalization , the study group patients were engaged in a fifteen-minute discussion regarding the association between osteoporosis and hip fractures , the efficacy of dual-energy x-ray absorptiometry scans in the diagnosis of osteoporosis and of bisphosphonates in its treatment , and the importance of medical follow-up for osteoporosis management . These patients were also provided with five questions regarding osteoporosis treatment to be given to their primary medical physician , and they were reminded about the questions during a follow-up telephone call six weeks later . The patients in the control group received a brochure describing methods for preventing falls . Both groups were contacted by telephone at six months after discharge to determine whether osteoporosis had been addressed . Positive indicators of intervention included assessment of bone mineral density with dual-energy x-ray absorptiometry and initiation of antiresorptive therapy . RESULTS The average age in each group was eighty-two years , and 78 % of the patients were female . Four patients in each group did not survive through the six-month follow-up period and were excluded from the trial . Fifteen ( 42 % ) of the thirty-six patients who had been r and omized to the study group , compared with only seven ( 19 % ) of the thirty-six patients in the control group , had their osteoporosis addressed by their primary physician . This difference between the groups was significant ( p = 0.036 ) . CONCLUSIONS Patients who were provided with information and questions for their primary care physician about osteoporosis were more likely to receive appropriate therapeutic intervention than were patients who had not received the information and questions . Orthopaedic surgeons have a unique opportunity to improve the rate of osteoporosis treatment in the perioperative period following a hip fracture by educating patients and directing them toward channels for long-term osteoporosis management",
"Background : Older patients who experience a fragility fracture are at high risk of future fractures but are rarely tested or treated for osteoporosis . We developed a multifaceted intervention directed at older patients with wrist fractures ( in the form of telephone-based education ) and their physicians ( in the form of guidelines endorsed by opinion leaders , supported by reminders ) to improve the quality of osteoporosis care . Methods : In a r and omized controlled trial with blinded ascertainment of outcomes , we compared our intervention with usual care ( provision of printed educational material s to patients ) . Eligible patients were those older than 50 years of age who had experienced a wrist fracture and were seen in emergency departments and fracture clinics ; we excluded those who were already being treated for osteoporosis . The primary outcome was bisphosphonate treatment within 6 months after the fracture . Secondary outcomes included bone mineral density testing , “ appropriate care ” ( consisting of bone mineral density testing with treatment if bone mass was low ) and quality of life . Results : We screened 795 patients for eligibility and r and omly assigned 272 to the intervention ( 137 patients ) or control ( 135 patients ) group . The median age was 60 years ; 210 ( 77 % ) of the subjects were women , and 130 ( 48 % ) reported a previous fracture as an adult . Six months after the fracture , 30 ( 22 % ) of the intervention patients , as compared with 10 ( 7 % ) of the control patients , were receiving bisphosphonate therapy for osteoporosis ( adjusted relative risk [ RR ] 2.6 , 95 % confidence interval [ CI ] 1.3–5.1 , p = 0.008 ) . Intervention patients were more likely than control patients to undergo bone mineral density testing ( 71/137 [ 52 % ] v. 24/135 [ 18 % ] ; adjusted RR 2.8 , 95 % CI 1.9–4.2 , p receive appropriate care ( 52/137 [ 38 % ] v. 15/135 [ 11 % ] ; adjusted RR 3.1 , 95 % CI 1.8–5.3 , p died , and 4 others experienced recurrent fracture . Interpretation : A multifaceted intervention directed at high-risk patients and their physicians substantially increased rates of testing and treatment for osteoporosis . Nevertheless , more than half of the patients in the intervention group were not receiving appropriate care 6 months after their fracture , which suggests that additional strategies should be explored . ( Clinical Trials.gov trial register no. NCT00152321 .",
"BACKGROUND Patients who survive hip fracture are at high risk of recurrent fractures , but rates of osteoporosis treatment 1 year after sustaining a fracture are less than 10 % to 20 % . We have developed an osteoporosis case manager intervention . The case manager educated patients , arranged bone mineral density tests , provided prescriptions , and communicated with primary care physicians . The intervention was compared with usual care in a r and omized controlled trial . METHODS We recruited from all hospitals that participate in the Capital Health system ( Alberta , Canada ) , including patients 50 years or older who had sustained a hip fracture and excluding those who were receiving osteoporosis treatment or who lived in a long-term care facility . Primary outcome was bisphosphonate therapy 6 months after fracture ; secondary outcomes included bone mineral density testing , appropriate care ( bone mineral density testing and treatment if bone mass was low ) , and intervention costs . RESULTS We screened 2219 patients and allocated 220 , as follows : 110 to the intervention group and 110 to the control group . Median age was 74 years , 60 % were women , and 37 % reported having had previous fractures . Six months after hip fracture , 56 patients in the intervention group ( 51 % ) were receiving bisphosphonate therapy compared with 24 patients in the control group ( 22 % ) ( adjusted odds ratio , 4.7 ; 95 % confidence interval , 2.4 - 8.9 ; P Bone mineral density tests were performed in 88 patients in the intervention group ( 80 % ) vs 32 patients in the control group ( 29 % ) ( P bone mineral density testing , 25 ( 21 % ) had normal bone mass . Patients in the intervention group were more likely to receive appropriate care than were patients in the control group ( 67 % vs 26 % ; P intervention cost was $ 50.00 per patient . CONCLUSION For a modest cost , a case manager was able to substantially increase rates of osteoporosis treatment in a vulnerable elderly population at high risk of future fractures",
"Recognizing Osteoporosis and its Consequences in Quebec ( ROCQ ) is an ongoing patient health-management programme aim ed at evaluating the diagnostic and treatment care gaps for osteoporosis following a fragility fracture , and subsequently initiating and measuring interventions to decrease these gaps in women 50 years of age and over . Hospitals servicing approximately half of the population of the Province of Quebec ( Canada ) are participating in the ROCQ programme . Women with fragility and traumatic fractures are approached during their visit to a cast or outpatient clinic and are subsequently contacted by telephone 0 to 16 weeks after their fracture ( phase 1 ) . During the first phone contact , they are invited to answer a question naire aim ed at identifying the specific circumstances of their fracture and asked to participate in an observational study that could last up to 18 months . Based on this initial question naire , patients are classified as having either experienced a fragility or traumatic fracture . During the first phone contact , there is no reference about the possible association between the fracture and osteoporosis and no investigation or intervention is proposed . Six to eight months after the fracture event ( phase 2 ) , women are again contacted by phone to complete a question naire that evaluates the diagnostic and treatment rates for osteoporosis . At this phase of the programme , women with fragility fractures are r and omized to one of the three following intervention groups : 1 ) Educational Video Group , 2 ) Documentation Group and 3 ) Control Group . Participants are contacted 12 to 14 months after the intervention ( phase 3 ) to evaluate the efficacy of the interventions on the diagnosis and treatment rates of osteoporosis . All participants with fragility or traumatic fractures who consent will be followed for 20 years using data from the Québec Ministry of Health data base to measure the association between the index fracture and future fracture risk",
"This article reports a controlled trial to investigate the effectiveness of patient education and a physician alerting system in altering secondary osteoporosis prevention after a low-trauma ( fragility ) wrist fracture and to record the current rate of osteoporosis investigation following such fractures . Fifty-one women and men aged 50 years or older with a low-trauma wrist fracture were identified ( 41 women and 10 men ; mean age [ 95 % CI ] , 71.51 [ 67.31 - 74.81 ] ) . The intervention group received a four-part intervention aim ed at both the patient and the family physician in addition to the usual care for the fracture . The control group only received usual care for the fracture . Data were collected for both groups at six weeks and six months . Results indicate that 92 % of the intervention subjects were investigated for osteoporosis , compared with the usual-care group , in which only 23 % were investigated . Early osteoporosis intervention has the potential to limit disease impact , and h and therapists can play a key role in early identification of osteoporosis",
"It is critical that the reporting of r and omized controlled trials ( RCTs ) be transparent and comprehensive . The aim of this study was to examine if adopting st and ards of reporting , the Consoli date d St and ards of Reporting Trials ( CONSORT ) , improved the quality of reporting of alcohol treatment outcome studies . RCTs were identified from eight journals publishing a substantial number of alcohol treatment outcome studies ( n=127 RCTs ) and coded for the quality of reporting according to the CONSORT guidelines . Both CONSORT adopter and non-adopter journals showed significant improvements in the quality of reporting of alcohol treatment outcome studies over time . While overall results suggested a non-significant trend for more improvement over time in the quality of reporting for adopter compared to non-adopter journals , comparison of effects sizes suggested that specific areas of reporting did significantly improve for the adopter journals . Results suggest that efforts to improve reporting such as the CONSORT guidelines can be useful and influential",
"OBJECTIVE We previously demonstrated that a case manager intervention improved osteoporosis ( OP ) treatment within 6 months of hip fracture compared with usual care . The second phase of the r and omized trial compared a less intensive intervention , facilitated bone mineral density ( BMD ) testing , with usual care and the case manager intervention . METHODS We initially r and omized 220 hip fracture patients to either an OP case manager intervention or usual care . After completing the original trial at 6 months postfracture , usual care patients were reallocated to facilitated BMD testing ; BMD tests were arranged and results sent to primary care physicians . Main outcomes ( bisphosphonate treatment , BMD tests , receipt of appropriate care ) were reascertained 1 year following hip fracture and compared with outcomes achieved by the OP case manager intervention and usual care . RESULTS Compared with usual care , facilitated BMD testing increased testing from 29 % to 68 % ( P bisphosphonate use from 22 % to 38 % ( P of appropriate care from 26 % to 45 % ( P OP case manager intervention led to significantly higher bisphosphonate use ( 54 % versus 38 % ; P = 0.03 ) , receipt of appropriate care ( 71 % versus 45 % ; P BMD testing ( 80 % versus 68 % ; P = 0.06 ) than usual care followed by facilitated BMD testing . CONCLUSION Compared with usual care , 2 different inexpensive interventions result ed in significant increases in appropriate management of OP after hip fracture . The magnitude of improvements achieved was directly related to the intensity of the interventions"
] | 41162b80-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVES To identify credible anchor-based minimal important differences ( MIDs ) for patient-reported outcome measures ( PROMs ) relevant to a BMJ Rapid Recommendations addressing subacromial decompression surgery for shoulder pain . DESIGN Systematic review . OUTCOME MEASURES Estimates of anchor-based MIDs , and their credibility , for PROMs judged by the parallel BMJ Rapid Recommendations panel as important for informing their recommendation ( pain , function and health-related quality of life ( HRQoL ) ) . DATA SOURCES MEDLINE , EMBASE and PsycINFO up to August 2018 . STUDY SELECTION AND REVIEW METHODS We included original studies of any intervention for shoulder conditions reporting estimates of anchor-based MIDs for relevant PROMs . Two review ers independently evaluated potentially eligible studies according to predefined selection criteria . Six review ers , working in pairs , independently extracted data from eligible studies using a pre design ed , st and ardised , pilot-tested extraction form and independently assessed the credibility of included studies using an MID credibility tool . RESULTS We identified 22 studies involving 5562 patients that reported 74 empirically estimated anchor-based MIDs for 10 c and i date instruments to assess shoulder pain , function and HRQoL. We identified MIDs of high credibility for pain and function outcomes and of low credibility for HRQoL. We offered median estimates for the systematic review team who applied these MIDs in Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) evidence summaries and in their interpretations of results in the linked systematic review addressing the effectiveness of surgery for shoulder pain . CONCLUSIONS Our review provides anchor-based MID estimates , as well as a rating of their credibility , for PROMs for patients with shoulder conditions . The MID estimates inform the interpretation for a linked systematic review and guideline addressing subacromial decompression surgery for shoulder pain , and could also prove useful for authors addressing other interventions for shoulder problems . PROSPERO REGISTRATION NUMBER CRD42018106531 | [
"Study Design A prospect i ve cohort study nested in a r and omized controlled trial . Objectives To determine and compare responsiveness and minimal clinical ly important change of the modified Constant score ( CS ) and the Oxford Shoulder Score ( OSS ) . Background The OSS and the CS are commonly used to assess shoulder outcomes . However , few studies have evaluated the measurement properties of the OSS and CS in terms of responsiveness and minimal clinical ly important change . Methods The study included 126 patients who reported having difficulty returning to usual activities 8 to 12 weeks after arthroscopic decompression surgery for subacromial impingement syndrome . The assessment at baseline and at 3 months included the OSS , the CS , and the European Quality of Life-5 Dimensions-3 Level ( EQ-5D-3L ) index . Responsiveness was assessed as follows : by correlation analysis between the change scores of the OSS , CS , and EQ-5D-3L index , and the Patient Global Impression of Change ( PGIC ) scale ; by receiver-operating-characteristic ( ROC ) curve analysis using the PGIC scale as an external anchor ; and by effect-size statistics . Results At 3 months , a follow-up assessment of 112 patients ( 89 % ) was conducted . The change scores of the CS and the OSS were more strongly correlated with the external anchor ( PGIC scale ) than the change score of the EQ-5D-3L index . The areas under the ROC curves exceeded 0.80 for both shoulder scores , with no significant differences between them , and comparable effect-size estimates were observed for the CS and the OSS . Minimal clinical ly important change ROC values were 6 points for the OSS and 11 points for the CS , with upper 95 % cutoff limits of 12 and 22 points , respectively . Conclusion The CS and the OSS were both suitable for assessing improvement after decompression surgery",
"INTRODUCTION This prospect i ve cohort study in consecutive shoulder patients sought to determine the minimal , clinical ly important difference of the Danish version of the Disabilities of the Arm , Shoulder and H and ( DASH ) question naire and to evaluate patient responsiveness to it . The study was undertaken at the Outpatient Clinic of the Department of Orthopaedic Surgery , Viborg Regional Hospital , Denmark . MATERIAL AND METHODS During clinical examination , patients completed a baseline question naire including the DASH question naire , the EuroQol-5D index and the EuroQol-VAS . A follow-up question naire concerning the patient 's global impression of change was posted to the patients eight to nine weeks after the initial assessment . Responsiveness was analysed by correlation analysis and receiver-operating characteristic curve statistics . Using the optimal cut-off point of the receiver-operating characteristic curve , the minimal , clinical ly important difference was determined . RESULTS A total of 81 patients with a variety of shoulder diagnoses were included . Only the DASH question naire demonstrated significant differences in change scores ( p = 0.001 ) . The area under the curve was 0.76 ( 95 % confidence interval 0.62 - 0.90 ) , and a minimal clinical ly important difference of 12 points was found . CONCLUSION The DASH question naire provides a response outcome measure in Danish-speaking orthopaedic shoulder patients . FUNDING This work was supported by the Regional Hospital of Central Jutl and Research Foundation . TRIAL REGISTRATION not relevant",
"Background Subacromial pain syndrome ( SPS ) involving rotator cuff tendinopathy is a common cause of shoulder pain and disability . Evidence suggests that structured physiotherapy may be as effective as surgery in this condition with significant improvements demonstrated in trials involving scapular retraining , rotator cuff strengthening and flexibility exercises . Most published programs typically utilise isotonic concentric and /or eccentric strengthening modes . Recently , immediate analgesic effects and muscle strength gains following heavy-load isometric exercises in lower limb tendinopathy conditions have been observed . It is pertinent to ascertain whether such outcomes can be replicated in SPS/rotator cuff tendinopathy . The primary aim of this study is to establish the feasibility of undertaking a full-scale r and omised controlled trial ( RCT ) that compares the effects of isometric , isotonic concentric and isotonic eccentric rotator cuff contractions when used as part of a semi-st and ardised exercise-based physiotherapy program in patients diagnosed with SPS . The secondary aim is to explore potential trends or treatment effects of the exercise intervention . Methods Thirty-six participants diagnosed with SPS will be r and omised to one of three intervention groups and undergo a one-on-one exercise-based physiotherapy intervention , involving scapular and rotator cuff muscle retraining and strengthening . Each group will utilise a different mode of rotator cuff strengthening — isometric , isotonic concentric or isotonic eccentric . Rotator cuff tendon responses to isometric loading are not yet established in the literature ; hence , individualised , progressive loading will be used in this pilot study in accordance with symptoms . The intervention will involve two phases : during Phase 1 ( weeks 1–6 ) participants undertake the active group-specific physiotherapy treatment ; in Phase 2 ( weeks 6–12 ) , they undertake a progressive , but no longer group-specific exercise program . To determine feasibility , an evaluation of key study parameters including ( a ) ease of recruitment ( rate and number as well as suitability of the assessment algorithm ) , ( b ) adherence to all phases of the exercise intervention including home program compliance and logbook completion , ( c ) participant non-completion ( drop out number and rate ) and ( d ) adverse events ( nature and number ) will be undertaken . Secondary outcomes will measure immediate effects : ( i ) within-treatment changes in pain perception ( verbal rating scale ( VRS ) and shoulder muscle strength ( h and -held dynamometer ) as well as longer-term changes : ( ii ) shoulder-related symptoms and disability ( Western Ontario Rotator Cuff Index ( WORC ) and Shoulder Pain and Disability Index ( SPADI ) ) , ( iii ) perception of pain ( 11-point numerical rating scale ( NRS ) , ( iv ) shoulder muscle strength ( h and -held dynamometer ) and ( v ) perceived global rating of change score . The immediate within-treatment assessment of pain and muscle strength will be undertaken in treatments 2 and 3 , and the longer term measures will be collected at the primary ( conclusion of Phase 1 at 6 weeks ) and secondary ( conclusion of Phase 2 at 12 weeks ) end-points of the study . Discussion The findings of this pilot study will permit evaluation of this study design for a full-scale RCT .Trial registration Australian New Zeal and Clinical Trials Registry ,",
"In recent years quality of life instruments have been featured as primary outcomes in many r and omized trials . One of the challenges facing the investigator using such measures is determining the significance of any differences observed , and communicating that significance to clinicians who will be applying the trial results . We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change . Using this approach we have established a plausible range within which the minimal clinical ly important difference ( MCID ) falls . In three studies in which instruments measuring dyspnea , fatigue , and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item , when responses were presented on a seven point Likert scale . Furthermore , we have established ranges for changes in question naire scores that correspond to moderate and large changes in the domains of interest . This information will be useful in interpreting question naire scores , both in individuals and in groups of patients participating in controlled trials , and in the planning of new trials",
"# # # What you need to know What is the role of arthroscopic surgery in degenerative knee disease ? An expert panel produced these recommendations based on a linked systematic review triggered by a r and omised trial published in The BMJ in June 2016 , which found that , among patients with a degenerative medial meniscus tear , knee arthroscopy was no better than exercise therapy . The panel make a strong recommendation against arthroscopy for degenerative knee disease . Box 1 shows all of the articles and evidence linked in this Rapid Recommendation package . The infographic provides an overview of the absolute benefits and harms of arthroscopy in st and ard GRADE format . Table 1 below shows any evidence that has emerged since the publication of this article . Box 1 # # # Linked articles in this BMJ Rapid Recommendations",
"Background The aim of this study was to assess the psychometric properties , namely acceptability , validity , reliability , interpretability and responsiveness of the EuroQol EQ-5D ( EQ-5D visual analogue ( VAS ) and EQ-5D ( utility ) ) , Short Form 12 Dimensions ( SF-12 ) , SF-6D and Michigan H and Outcome Question naire ( MHQ ) in patients with rheumatoid arthritis ( RA ) of the h and . Methods The empirical investigation was based upon data from a r and omised controlled trial of 488 adults with rheumatoid arthritis who had pain and dysfunction of the h and s and /or wrists . Participants completed the EQ-5D , SF-12 and MHQ at baseline and at 4 and 12 months follow up . Acceptability was measured using completion rates over time ; construct validity using the “ known groups ” approach , based on pain troublesomeness ; convergent validity using spearman ’s rho correlation ( ρ ) ; reliability using internal consistency ( Cronbach ’s alpha ) ; interpretability using minimal important differences ( MID ) ; and responsiveness using effect sizes and st and ardised response means ( SRM ) stratified by level of self-rated improvement in h and and wrist function or level of self-rated benefit and satisfaction from trial treatments . Results At baseline , the study population had a mean age of 62.4 years , a mean MHQ score of 52.1 and included 76 % women . The EQ-5D ( utility ) had the highest completion rates across time points . All instruments discriminated between pre-specified groups based on pain troublesomeness . Convergent validity analysis indicated that the MHQ score correlated strongly with the EQ-5D ( ρ = 0.65 ) and SF-6D ( ρ = 0.63 ) utility scores . The MHQ was most responsive at detecting change in indicators of RA pain severity between baseline and 4 months , whilst minimal important differences varied considerably across PROMs . Conclusions The instruments evaluated in this study displayed varying psychometric properties in the context of RA of the h and . The selection of a preferred instrument in evaluative studies should ultimately depend on the relative importance placed on individual psychometric properties and the importance placed on generation of health utilities for economic evaluation purpose",
"Background : Dysfunction in the kinetic chain caused by poor scapula stabilization can contribute to shoulder injuries and Shoulder Impingement Syndrome ( SIS ) . The purpose of this study was to compare the effectiveness of two treatment approaches scapular stabilization based exercise therapy and physical therapy in patients with SIS . Methods : The study is a r and omized clinical trial in which 68 patients with SIS were r and omly assigned in two groups of exercise therapy ( ET ) and physical therapy ( PT ) and received 18 sessions of treatment . Pain , shoulders ' range of abduction and external rotation , shoulder protraction , scapular rotation and symmetry as well as postural assessment and Pectoralis minor length were evaluated pre and post intervention . The paired- sample t test and the independent sample t test were applied respectively to determine the differences in each group and between two groups . Results : Our findings indicated significant differences in abduction and external rotation range , improvement of forward shoulder translation and increase in the flexibility of the involved shoulder between the two groups ( respectively ; p=0.024 , p=0.001 , p pain reduction between the groups ( p=0.576 ) . Protraction of the shoulder ( p forward head posture ( p mid thoracic curvature ( p scapular rotation and symmetry in both groups but no significant differences were observed between the two groups ( respectively ; p=0.183 , p=0.578 ) . Conclusion : The scapular stabilization based exercise intervention was successful in increasing shoulder range , decreasing forward head and shoulder postures and Pectoralis minor flexibility",
"Abstract Purpose : Investigate test -- retest reliability and validity of five shoulder outcome measures in people during their active rehabilitation after a shoulder fracture . Method : This prospect i ve longitudinal study assessed shoulder function in 20 people ( 16 women , mean age 68.1 years ) with surgical or conservative management at 6 , 12 and 13 weeks post proximal humeral fracture using three patient-reported ( Disabilities of Arm , Shoulder and H and ; Oxford Shoulder Score ; Subjective Shoulder Value ) and two clinician-administered ( Constant Score ; UCLA Shoulder score ) outcome measures . Results : Content analysis categorised items into multiple domains of functioning for each outcome measure . Construct validity testing between measures found moderate to strong correlations ( r = 0.43–0.92 ) . Longitudinal validity ( responsiveness ) , represented by correlations between change scores , was moderate to strong ( r = 0.44–0.83 ) . Although ICCs2,1 for test – retest reliability ranged from 0.75 to 0.93 , Limits of Agreement between measurements were relatively wide ( 10–23 % of available range of scores ) . Minimal clinical ly important difference estimates varied between anchor- and distribution-based methods . Conclusions : The five outcome measures assessing shoulder function provided values for reliability and validity that meet measurement requirements for use in groups of people after a proximal humeral fracture . However , the use of these outcome measures might be limited by low absolute agreement between measurements and their content covering multiple domains of functioning . Implication s for Rehabilitation Linking the International Classification of Functioning , Disability and Health ( ICF ) to the content of common shoulder function outcome measures showed that multiple domains of functioning are combined into a single score . This might not be preferred for measurement of the single construct of “ shoulder function ” . Currently available shoulder function outcome measures may not be sufficiently reliable to monitor change in an individual after a proximal humeral fracture during the rehabilitation phase",
"Objective . The Outcome Measures in Rheumatology ( OMERACT ) Shoulder Core Outcome Set Special Interest Group ( SIG ) was established to develop a core outcome set ( COS ) for clinical trials of shoulder disorders . Methods . In preparation for OMERACT 2016 , we systematic ally examined all outcome domains and measurement instruments reported in 409 r and omized trials of interventions for shoulder disorders published between 1954 and 2015 . Informed by these data , we conducted an international Delphi consensus study including shoulder trial experts , clinicians , and patients to identify key domains that should be included in a shoulder disorder COS . Findings were discussed at a stakeholder premeeting of OMERACT . At OMERACT 2016 , we sought consensus on a preliminary core domain set and input into next steps . Results . There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting , respectively ( 9 attended both meetings ) . Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains : pain , physical function/activity , global perceived effect , and adverse events including death . A middle core consisted of 3 domains : emotional well-being , sleep , and participation ( recreation and work ) . An outer core of research required to inform the final COS was also formulated . Conclusion . Our next steps are to ( 1 ) analyze whether participation ( recreation and work ) should be in the inner core , ( 2 ) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains , and ( 3 ) determine which instruments fulfill the OMERACT criteria for measuring each domain",
"OBJECTIVE To determine the most appropriate means to assess the response to treatment in terms of pain and functional impairment in a chronic rheumatic condition ( knee osteoarthritis [ OA ] ) and an acute rheumatic condition ( rotator cuff syndrome [ RCS ] ) . METHODS Two prospect i ve studies were conducted consisting of 1,019 out patients with knee OA and 271 patients with acute RCS . The minimal clinical ly important improvement and the patient acceptable symptom state were determined for knee OA pain using a visual analog scale , and for knee OA function using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale ; for acute RCS pain , a numeral rating scale was used , and the Neer function subscale was used for RCS function . RESULTS The minimal clinical ly important improvement was shown to be the change required to achieve the patient acceptable symptom state , whatever the baseline level of symptom , the outcome ( pain or function ) , or type of condition ( chronic or acute ) . This acceptable state for pain was higher for chronic ( 27.0 - 36.4 across the baseline score ) than acute ( 16.7 - 24.1 ) conditions . The level of functional impairment considered satisfactory by patients with knee OA was higher for more disabled patients ( 43.1 ) than for less disabled patients ( 20.4 ) . CONCLUSION Patients consider that they experienced an important improvement only if this improvement allowed them to achieve a state they consider satisfactory . The most appropriate means to assess the response to therapy seems to be to assess whether patients feel good ( i.e. , achieve the patient acceptable symptom state )",
"BACKGROUND Shoulder pain or omalgia is one of the main types of osteoarticular pain that can be observed in every-day clinical practice , frequently causing significant functional impairment . The most common cause of shoulder pain is impingement syndrome . OBJECTIVE To decrease the intensity of short- and mid-term pain in the injured shoulder by means of acupuncture . METHOD R and omized controlled trial with two groups of participants : one group received true acupuncture ( TA ) and the other received acupuncture at sham points ( SA ) . The treatment was carried out over 4 weeks , with the participants receiving a session every week . The results were measured immediately after the treatment ( T1 ) and 3 months later ( T2 ) . To evaluate the results , we used the 100 mm Visual Analogue Scale ( VAS ) , and to assess the functionality of the shoulder we employed the UCLA question naire ( 0 - 35 points ) . RESULTS A total of 68 participants were included in the analysis ( TA , n=35 ; SA , n=33 ) , with a mean age of 33.4 years ( SD 12.53 ) . We found significant differences in the analyzed results between the two groups , as we observed a decrease on the intensity of pain for the TA group of 44.13 mm at T1 ( CI 95 % 36.7 ; 51.5 ) and 87.58 mm at T2 ( CI 95 % 28.32 ; 46.81 ) , while the decrease in the FA group was of 19.84 mm at T1 ( CI 95 % 12.2 ; 27.4 ) and 20 mm at T2 ( CI 95 % 10.9 ; 29.09 ) . When the UCLA scores were analyzed , the results were clinical ly meaningful in support of TA in terms of functional assessment of the shoulder . No adverse effects were reported . CONCLUSIONS The use of acupuncture to treat impingement syndrome seems to be a safe and reliable technique to achieve clinical ly significant results and could be implemented in the therapy options offered by the health services",
"BACKGROUND The minimal clinical ly important difference ( MCID ) is increasingly used to evaluate treatment effectiveness . The MCID for the Constant score has not been previously reported . MATERIAL S AND METHODS A prospect ively collected cohort of 802 consecutive shoulders with arthroscopically treated partial- or full-thickness rotator cuff tears was analyzed . The Constant score was measured preoperatively and at 3 months and 1 year postoperatively . At follow-up visits , the patients were asked a simple 2-stage question : Is the shoulder better or worse after the operation compared with the preoperative state ? This single 2-level question was used as an indicator of patient satisfaction and as an anchor to calculate the MCID for the Constant score . RESULTS At 1 year , 781 ( 97.4 % ) patients ( 474 men , 307 women ) were available for follow-up . The preoperative Constant score was 53.1 ( SD 17.2 ) in all patients , 56.2 ( SD 17.4 ) in male patients , and 48.2 ( SD 15.6 ) in female patients . Postoperatively at 3 months , the scores were 61.7 ( SD 16.4 ) in all patients , 65.1 ( SD 16.1 ) in male patients , and 56.8 ( SD 15.5 ) in female patients . At 1 year , the scores were 75.9 ( SD 15.2 ) in all patients , 79.0 ( SD 14.9 ) in male patients , and 71.0 ( SD 14.3 ) in female patients . At 3 months postoperatively , 92.2 % of male patients and 87.2 % of female patients were satisfied with the outcome ( P = .027 ) ; at 1 year , the satisfaction was 93.2 % and 89.5 % , respectively ( P = .067 ) . Five different statistical approaches yielded 5 different MCID estimates ( range , 2 - 16 ) . The 3-month mean change estimate of MCID was 10.4 points . CONCLUSION Our study demonstrates an MCID estimate of 10.4 points as the threshold for the Constant score in patients with rotator cuff tear . LEVEL OF EVIDENCE Basic science study , validation of outcomes instruments/classification systems",
"Abstract Objective To assess the efficacy of arthroscopic subacromial decompression ( ASD ) by comparing it with diagnostic arthroscopy , a placebo surgical intervention , and with a non-operative alternative , exercise therapy , in a more pragmatic setting . Design Multicentre , three group , r and omised , double blind , sham controlled trial . Setting Orthopaedic departments at three public hospitals in Finl and . Participants 210 patients with symptoms consistent with shoulder impingement syndrome , enrolled from 1 February 2005 with two year follow-up completed by 25 June 2015 . Interventions ASD , diagnostic arthroscopy ( placebo control ) , and exercise therapy . Main outcome measures Shoulder pain at rest and on arm activity ( visual analogue scale ( VAS ) from 0 to 100 , with 0 denoting no pain ) , at 24 months . The threshold for minimal clinical ly important difference was set at 15 . Results In the primary intention to treat analysis ( ASD versus diagnostic arthroscopy ) , no clinical ly relevant between group differences were seen in the two primary outcomes at 24 months ( mean change for ASD 36.0 at rest and 55.4 on activity ; for diagnostic arthroscopy 31.4 at rest and 47.5 on activity ) . The observed mean difference between groups ( ASD minus diagnostic arthroscopy ) in pain VAS were −4.6 ( 95 % confidence interval −11.3 to 2.1 ) points ( P=0.18 ) at rest and −9.0 ( −18.1 to 0.2 ) points ( P=0.054 ) on arm activity . No between group differences were seen between the ASD and diagnostic arthroscopy groups in the secondary outcomes or adverse events . In the secondary comparison ( ASD versus exercise therapy ) , statistically significant differences were found in favour of ASD in the two primary outcomes at 24 months in both VAS at rest ( −7.5 , −14.0 to −1.0 , points ; P=0.023 ) and VAS on arm activity ( −12.0 , −20.9 to −3.2 , points ; P=0.008 ) , but the mean differences between groups did not exceed the pre-specified minimal clinical ly important difference . Of note , this ASD versus exercise therapy comparison is not only confounded by lack of blinding but also likely to be biased in favour of ASD owing to the selective removal of patients with likely poor outcome from the ASD group , without comparable exclusions from the exercise therapy group . Conclusions In this controlled trial involving patients with a shoulder impingement syndrome , arthroscopic subacromial decompression provided no benefit over diagnostic arthroscopy at 24 months . Trial registration Clinical trials.gov NCT00428870",
"OBJECTIVE The purpose of this study was to determine the minimal important change ( MIC ) of improvement in the Constant-Murley score in patients with long-st and ing subacromial pain and in subgroups of patients with subacromial pain with and without rotator cuff ruptures . METHOD The MIC was estimated by the anchor-based MIC distribution method , which integrates an anchor- and distribution-based approach : the optimal cutoff point of the receiver operating characteristic curve ( MICROC ) and the 95 % limit cutoff point ( MIC95 % limit ) . The study population consisted of 93 patients included in a r and omized clinical trial evaluating the effect of a specific exercise strategy . RESULTS The MICROC was found at a mean change of 17 points in the Constant-Murley score , which corresponds to a sensitivity of 91 % and a specificity of 79 % . The MIC95 % limit was found at a mean change of 24 points . In the subgroup analysis , the MICROC was found at a mean change of 19 points and the MIC95 % limit at 18 points in patients with an intact rotator cuff . In patients with rotator cuff ruptures , the MICROC was found at a mean change of 15 points and the MIC95 % limit at 30 points . CONCLUSION The Constant-Murley score is able to detect the MIC in individual patients with long-st and ing subacromial pain when the rotator cuff is intact . The estimated MIC values could be used as an indication for relevant changes in the Constant-Murley score in clinical practice and guide the clinician in how to interpret the results of specific treatments"
] | 41162bc6-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND & AIMS Data about the effects of cinnamon supplementation on obesity measures are conflicting . This systematic review and meta- analysis of r and omized controlled trials ( RCTs ) was conducted to summarize the effects of cinnamon intake on body weight ( BW ) , Body Mass Index ( BMI ) , Waist Circumference ( WC ) , and fat mass ( FM ) in adults . METHODS Online electronic search engines including PubMed , SCOPUS , Cochrane Library , and Google Scholar were search ed to find pertinent articles until September 2018 . Data were pooled using the r and om-effects method and were expressed as weighted mean difference ( WMD ) and 95 % confidence intervals ( CI ) . The non-linear association was assessed using fractional polynomial modeling . RESULTS Out of 679 records , 12 trials that enrolled 786 subjects were included . The pooled results showed that cinnamon administration significantly decreased BW ( WMD : -1.02 kg , 95 % CI : -1.66 to -0.38 , P = 0.002 ) , BMI ( WMD : -0.51 kg/m2 , 95 % CI : -0.74 , -0.28 , P 0.001 ) , WC ( WMD : -2.40 cm , 95 % CI : -4.48 , -0.33 , P = 0.02 ) , and FM ( WMD : -1.02 % , 95 % CI : -1.80 , -0.24 , P = 0.01 ) . Greater effects on BW were observed in subjects aged . The cinnamon administrations significantly reduced FM at the dosages of ≥2 g/d , when administered for ≥12 weeks . Cinnamon administration result ed in BW and WC reduction in non-linear fashion ( P = 0.04 ) . CONCLUSIONS Cinnamon supplementation significantly affects obesity measures . It could be recommended as a weight-reducing supplement in obesity management | [
"Background : Many foods and nutrients have been suggested to influence life expectancy . However , previous studies have not examined the relationship between dietary patterns and cause-specific mortality . Our study prospect ively examines the relationship of dietary patterns with total mortality and cause-specific mortality in a population -based cohort study of Chinese women . Methods : The Shanghai Women 's Health Study is a population -based cohort study of 74,942 women age 40 to 70 years at the time of recruitment ( September 1996 to May 2000 ) . Detailed dietary information was collected using a vali date d , quantitative food frequency question naire . The cohort has been followed using a combination of in-person interviews and record linkage with various registries . Dietary patterns , derived from principal component analysis , were examined for their relation to total mortality and cause-specific mortality using Cox regression models . Results : After an average of 5.7 years of follow-up ( 423,717 person-years of observation ) , there were 1565 deaths . We derived 3 major dietary patterns ( vegetable-rich , fruit-rich , and meat-rich ) . The adjusted hazard ratios for the fruit-rich diet were 0.94 ( 95 % CI = 0.89–0.98 ) for all causes of death and 0.89 ( 0.81–0.99 ) , 0.79 ( 0.69–0.91 ) , and 0.51 ( 0.39–0.65 ) for death caused by cardiovascular disease , stroke , and diabetes , respectively . The meat-rich diet was associated with increased risk of diabetes ( HR = 1.18 ; 95 % CI = 0.98–1.42 ) and a slightly elevated risk of total mortality . Conclusion : In general , a fruit-rich diet was related to lower mortality , whereas a meat-rich diet appeared to increase the probability of death",
"OBJECTIVE The objective of this study was to determine whether cinnamon improves blood glucose , triglyceride , total cholesterol , HDL cholesterol , and LDL cholesterol levels in people with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 60 people with type 2 diabetes , 30 men and 30 women aged 52.2 + /- 6.32 years , were divided r and omly into six groups . Groups 1 , 2 , and 3 consumed 1 , 3 , or 6 g of cinnamon daily , respectively , and groups 4 , 5 , and 6 were given placebo capsules corresponding to the number of capsules consumed for the three levels of cinnamon . The cinnamon was consumed for 40 days followed by a 20-day washout period . RESULTS After 40 days , all three levels of cinnamon reduced the mean fasting serum glucose ( 18 - 29 % ) , triglyceride ( 23 - 30 % ) , LDL cholesterol ( 7 - 27 % ) , and total cholesterol ( 12 - 26 % ) levels ; no significant changes were noted in the placebo groups . Changes in HDL cholesterol were not significant . CONCLUSIONS The results of this study demonstrate that intake of 1 , 3 , or 6 g of cinnamon per day reduces serum glucose , triglyceride , LDL cholesterol , and total cholesterol in people with type 2 diabetes and suggest that the inclusion of cinnamon in the diet of people with type 2 diabetes will reduce risk factors associated with diabetes and cardiovascular diseases",
"BACKGROUND & AIMS Multiple studies have evaluated the hypoglycemic effect of cinnamon in patients with diabetes mellitus ( DM ) type II , with conflicting results . Differences in Baseline Body Mass Index ( BMI ) of patients may be able to explain the observed differences in the results . This study was design ed to evaluate the effect of cinnamon supplementation on anthropometric , glycemic and lipid outcomes of patients with DM type II based on their baseline BMI . METHODS The study was design ed as a triple-blind placebo-controlled r and omized clinical trial , using a parallel design . One hundred and forty patients referred to Diabetes Clinic of Yazd University of Medical Sciences with diagnosis of DM type II were r and omly assigned in four groups : cinnamon ( BMI ≥ 27 , BMI Placebo ( BMI ≥ 27 , BMI received cinnamon bark powder or placebo in 500 mg capsules twice daily for 3 months . Anthropometric , glycemic and lipid outcomes were measured before and after the intervention . RESULT Cinnamon supplementation led to improvement of all anthropometric ( BMI , body fat , and visceral fat ) , glycemic ( FPG , 2hpp , HbA1C , Fasting Insulin , and Insulin Resistance ) , and lipids ( Cholesterol Total , LDL-c and HDL-c ) outcomes ( except for triglycerides level ) . All observed changes ( except for Cholesterol Total and LDL-c ) were significantly more prominent in patients with higher baseline BMI ( BMI ≥ 27 ) . CONCLUSION Based on the study findings , cinnamon may improve anthropometric parameters , glycemic indices and lipid profile of patients with type II diabetes . These benefits are significantly more prominent in patients with higher baseline BMI ( BMI ≥ 27 ) . The trial protocol was registered in Iranian Registry of Clinical Trials data base ( registration ID : I RCT 2017031133015N1 )",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"AIMS Various spices display insulin-potentiating activity in vitro , and in particular , cinnamon spice and its phenolic extracts have been shown to exhibit these capabilities . In vivo study shows that cinnamon may have beneficial effects on glucose homeostasis ; therefore the aim of this study was to further investigate this phenomenon in humans . METHODS Seven lean healthy male volunteers , aged 26 + /- 1 years , body mass index 24.5 + /- 0.3 kg/m(2 ) ( mean + /- s.e.m . ) , underwent three oral glucose tolerance tests ( OGTT ) supplemented with either a 5 g placebo ( OGTT(control ) ) , 5 g of cinnamon ( OGTT(cin ) ) , or 5 g of cinnamon taken 12 h before ( OGTT(cin12hpre ) ) in a r and omized-crossover design . RESULTS Cinnamon ingestion reduced total plasma glucose responses ( AUC ) to oral glucose ingestion [ -13 % and -10 % for OGTT(cin ) ( p insulin sensitivity as assessed by insulin sensitivity index measures based on Matsuda 's model in both OGTT(cin ) ( p cinnamon spice supplementation may be important to in vivo glycaemic control and insulin sensitivity in humans , and not only are its effects immediate , they also appear to be sustained for 12",
"Cinnamon ( 肉桂 ròu guì ) has in vitro insulin potentiating activity , and proanthocyanidins from cinnamon prevent in vitro formation of advanced glycation end products . Some human studies were equivocal , but several have shown beneficial effects of cinnamon supplementation on circulating glucose , lipids , and /or insulin . This placebo-controlled double-blind trial tested the effects of a dried water extract of cinnamon ( Cinnamomum cassia ) on circulating glucose , lipids , insulin , and insulin resistance . Men and women from Beijing and Dalian , China , were invited to participate if they had fasting serum glucose > 6.1 mmol/L or 2-h glucose > 7.8 mmol/L. Participants , ( 173 were enrolled and 137 completed the study ) were r and omly assigned to receive either a spray-dried , water extract of cinnamon ( CinSulin ® ) , 250 mg/capsule , or a placebo , twice a day for two months . Mean ± SEM age of participants was 61.3 ± 0.8 years , BMI was 25.3 ± 0.3 and M/F ratio was 65/72 . After 2 mo , fasting glucose decreased ( p the cinnamon extract-supplemented group ( 8.85 ± 0.36 to 8.19 ± 0.29 mmol/L ) compared with the placebo group ( 8.57 ± 0.32 to 8.44 ± 0.34 mmol/L , p = 0.45 ) . Glucose 2 h after a 75 g carbohydrate load , fasting insulin , and HOMA-IR also decreased with cinnamon extract compared with placebo . Total and LDL-cholesterol decreased with cinnamon extract and HDL-cholesterol decreased in both the cinnamon-extract and placebo groups . In conclusion , supplementation with 500 mg of water-extract of cinnamon for two months reduced fasting insulin , glucose , total cholesterol , and LDL cholesterol and enhanced insulin sensitivity of subjects with elevated blood glucose ",
"Objective : Type 2 diabetes is the most common metabolic disorder worldwide . Traditional herbs and spices can be used to control blood glucose concentrations . The objective of this study was to evaluate the effects of the daily intake of three grams cinnamon over eight weeks on glycemic status , lipid profiles and body composition in type 2 diabetic patients . Methods : A double blind , r and omized , placebo controlled clinical trial was conducted on 44 patients with type 2 diabetes . Participants were r and omly assigned to take either a three g/day cinnamon supplement ( n=22 ) or a placebo ( n=22 ) for eight weeks . Weight , height , body fat mass and systolic and diastolic blood pressure were measured at baseline and after intervention . The fasting blood glucose , insulin , HbA1c , total cholesterol , LDL C , HDL C , Apo lipoprotein A I and B were measured at baseline and endpoint . Results : From 44 subjects participated in this study 37 completed the study . There were no significant differences in baseline characteristics , dietary intake and physical activity between groups . In the treatment group , the levels of fasting blood glucose , HbA1c , triglyceride , weight , BMI and body fat mass decreased significantly compared to baseline , but not in placebo group . No significant differences were observed in glycemic status indicators , lipid profile and anthropometric indicators between the groups at the end of intervention . Conclusion : These data suggest that cinnamon may have a moderate effect in improving glycemic status indicators",
"For thous and s of years , cinnamon has been used as a traditional treatment in China . However , there are no studies to date that investigate whether cinnamon supplements are able to aid in the treatment of type 2 diabetes in Chinese subjects . We hypothesized cinnamon should be effective in improving blood glucose control in Chinese patients with type 2 diabetes . To address this hypothesis , we performed a r and omized , double-blinded clinical study to analyze the effect of cinnamon extract on glycosylated hemoglobin A(1c ) and fasting blood glucose levels in Chinese patients with type 2 diabetes . A total of 66 patients with type 2 diabetes were recruited and r and omly divided into 3 groups : placebo and low-dose and high-dose supplementation with cinnamon extract at 120 and 360 mg/d , respectively . Patients in all 3 groups took gliclazide during the entire 3 months of the study . Both hemoglobin A(1c ) and fasting blood glucose levels were significantly reduced in patients in the low- and high-dose groups , whereas they were not changed in the placebo group . The blood triglyceride levels were also significantly reduced in the low-dose group . The blood levels of total cholesterol , high-density lipoprotein cholesterol , low-density lipoprotein cholesterol , and liver transaminase remained unchanged in the 3 groups . In conclusion , our study indicates that cinnamon supplementation is able to significantly improve blood glucose control in Chinese patients with type 2 diabetes",
"Experimental and some clinical evidence suggests that ingestion of cinnamon may improve metabolic measures in individuals with diabetes ; however , few human studies have been design ed to examine this association as their primary objective . In this study adult subjects 30 years of age or older with type 2 diabetes were r and omized to treatment with 1,200 mg/day cinnamon or matched placebo . Blood pressure , hemoglobin A1c , fasting blood glucose , lipid profile , physical examination , and blood and urine chemistry were measured at baseline and at the 12-week follow-up end-of-treatment visit . In total , 59 subjects ( 40.7 % female ; mean age , 63.05±10.85 years ) were recruited . Systolic blood pressure ( SBP ) declined from baseline values by 3.4±11.4 mm Hg in the cinnamon group and increased by 1.9±10.2 mm Hg in the placebo group ( P=.06 ) . In repeated- measures analysis , a significant by-treatment difference over time was detected ( P=.02 ) . However , when baseline SBP was included in the model as a covariate , change from baseline SBP was no longer associated with treatment . Although cinnamon added to the diets of spontaneously hypertensive rats has been shown to decrease SBP in a dose-dependent manner , results of the present study in humans suggest that the by-treatment difference in change-from-baseline SBP was a function of regression to the mean rather than a treatment-associated change",
"Our aim is to assess the effect of cinnamon powder capsules on insulin resistance , anthropometric measurements , glucose and lipid profiles , and and rogens of women with polycystic ovarian syndrome ( PCOS ) . Out of 80 women that were diagnosed as PCOS by Rotterdam Criteria , 66 were enrolled in this r and omized double-blind placebo-controlled clinical trial . All of the PCOS women were taking medroxy progesterone acetate 10 mg/day for the last 10 days of their menstrual cycles . The cases were r and omly allocated to 2 groups . The women in the first group were treated by cinnamon powder capsules 1.5 g/day in 3 divided doses for 12 weeks and the second group by similar placebo capsules . Anthropometric measurements , fasting blood sugar , fasting insulin , blood glucose 2 hr after taking 75 g oral glucose , HbA1c , testosterone , dehydroepi and rosterone sulphate , homeostatic model assessment for insulin resistance , triglyceride , and cholesterol ( low-density lipoprotein , high-density lipoprotein , and total ) before and after the intervention were evaluated and compared as outcome measures . Fasting insulin ( p = .024 ) and homeostatic model assessment for insulin resistance ( p = .014 ) were reduced after 12 weeks in the cinnamon group compared with the placebo . There was also a significant decrease in low-density lipoprotein in cinnamon group ( p = .004 ) as compared with baseline that caused significant difference with placebo ( p = .049 ) . However , changes in other outcome measurements did not lead to statistically significant difference with placebo . The present results suggest that complementary supplementation of cinnamon significantly reduced fasting insulin and insulin resistance in women with PCOS",
"AIMS To determine the blood glucose lowering effect of cinnamon on HbA1c , blood pressure and lipid profiles in people with type 2 diabetes . METHODS 58 type 2 diabetic patients ( 25 males and 33 females ) , aged 54.9 ± 9.8 , treated only with hypoglycemic agents and with an HbA1c more than 7 % were r and omly assigned to receive either 2 g of cinnamon or placebo daily for 12 weeks . RESULTS After intervention , the mean HbA1c was significantly decreased ( P the cinnamon group ( 8.22 % to 7.86 % ) compared with placebo group ( 8.55 % to 8.68 % ) . Mean systolic and diastolic blood pressures ( SBP and DBP ) were also significantly reduced ( P the cinnamon group ( SBP : 132.6 to 129.2 mmHg and DBP : 85.2 to 80.2 mmHg ) compared with the placebo group ( SBP : 134.5 to 134.9 mmHg and DBP : 86.8 to 86.1 mmHg ) . A significant reduction in fasting plasma glucose ( FPG ) , waist circumference and body mass index ( BMI ) was observed at week 12 compared to baseline in the cinnamon group , however , the changes were not significant when compared to placebo group . There were no significant differences in serum lipid profiles of total cholesterol , triglycerides , HDL and LDL cholesterols neither between nor within the groups . CONCLUSIONS Intake of 2 g of cinnamon for 12 weeks significantly reduces the HbA1c , SBP and DBP among poorly controlled type 2 diabetes patients . Cinnamon supplementation could be considered as an additional dietary supplement option to regulate blood glucose and blood pressure levels along with conventional medications to treat type 2 diabetes mellitus",
"Purpose : Multiple trials in the past have shown conflicting results of whether cinnamon lowers glucose or hemoglobin A1C ( HbA1C ) . The purpose of this study was to determine whether cinnamon lowers HbA1C in patients with type 2 diabetes . I performed a r and omized , controlled trial to evaluate whether daily cinnamon plus usual care versus usual care alone lowers HbA1c . Methods : I r and omized 109 type 2 diabetics ( HbA1C > 7.0 ) from 3 primary care clinics caring for pediatric , adult , and geriatric patients at a United States military base . Participants were r and omly allocated to either usual care with management changes by their primary care physician or usual care with management changes plus cinnamon capsules , 1 g daily for 90 days . HbA1c was drawn at baseline and 90 days and compared with intention-to-treat analysis . This study was approved by an institutional review board . Results : Cinnamon lowered HbA1C 0.83 % ( 95 % CI , 0.46–1.20 ) compared with usual care alone lowering HbA1C 0.37 % ( 95 % CI , 0.15–0.59 ) . Conclusions : Taking cinnamon could be useful for lowering serum HbA1C in type 2 diabetics with HbA1C > 7.0 in addition to usual care",
"OBJECTIVE The aim of this study was to explore race-ethnic differences in the association between plasma lipid components and risk of incident myocardial infa rct ion ( MI ) . DESIGN / METHODS As part of the Northern Manhattan Study , 2,738 community residents without cardiovascular disease were prospect ively evaluated . Baseline fasting blood sample s were collected , and lipid panel components were analyzed as continuous and categorical variables . Cox proportional hazards models were used to calculate HRs and 95 % CIs for incident MI after adjusting for demographic and cardiovascular risk factors . RESULTS The mean age was 68.8 ± 10.4 years ; 36.7 % were men . Of the participants , 19.9 % were non-Hispanic white ; 24.9 % , non-Hispanic black ; and 52.8 % , Hispanic ( > 80 % from the Caribbean ) . Hispanics had lower mean high-density lipoprotein cholesterol ( HDL-C ) and higher triglycerides (TG)/HDL-C. During a mean 8.9 years of follow-up , there were 163 incident MIs . In the whole cohort , all lipid profile components were associated with risk of MI in the expected directions . However , HDL-C ( adjusted HR per 10 mg/dL increase 0.93 , 95 % CI 0.76 - 1.12 ) and TG/HDL-C > 2 ( adjusted HR 0.89 , 95 % CI 0.51 - 1.55 ) were not predictive of MI among Hispanics but were predictive among non-Hispanic blacks and whites . Triglycerides/HDL-C per unit increase was associated with an 8 % higher risk of MI among Hispanics ( adjusted HR 1.08 , 95 % CI 1.04 - 1.12 ) . CONCLUSIONS In Hispanics , low HDL-C and TG/HDL-C > 2 were not associated with MI risk . Our data suggest that a different TG/HDL ratio cutoff may be needed among Hispanics to predict MI risk",
"Nonalcoholic fatty liver disease ( NAFLD ) is the most prevalent cause of hepatic injury in the world . One of the most important therapeutic strategies for this disease is modulating insulin resistance and oxidative stress . In this study , we investigated the hypothesis that supplementation with cinnamon exerts an insulin sensitizer effect in patients with NAFLD . In a double-blind , placebo-controlled trial with two parallel groups , fifty patients with NAFLD were r and omized to receive daily supplementation with either two capsules of cinnamon ( each capsule contain 750 mg cinnamon ) or 2 placebo capsules , daily for 12 weeks . During the intervention , all patients were given advice on how to implement a balanced diet and physical activity into their daily lives . In the treatment group ( P HOMA ( Homeostatic Model Assessment ) index , FBS ( fasting blood glucose ) , total cholesterol , triglyceride , ALT ( alanine aminotransferase ) , AST ( aspartate aminotransferase ) , GGT ( gamma glutamine transpeptidase ) , and high-sensitivity C-reactive protein were seen , but there was no significant change in serum high-density lipoproteins levels ( P = .122 ) . In both groups , low-density lipoproteins decreased significantly ( P cinnamon daily may be effective in improving NAFLD characteristics",
"Cinnamomum zeylanicum ( cinnamon ) is a plant with potent antioxidant activity and has been used in traditional medicine for improvement of heart function . The effects of cinnamon bark ethanolic extract were investigated against ischemia-induced arrhythmias and heart injury in an in vivo rat model of regional heart ischemia . The extract was also st and ardized , and its antioxidant activity was evaluated . Adult male Sprague-Dawley rats were subjected to 30 min of ischemia by occlusion of the left anterior descending coronary artery followed by 5 days of reperfusion . Thirty-two animals were r and omized to receive daily oral administration of vehicle or C. zeylanicum bark extract ( intragastric , 50 , 100 , or 200 mg/kg ) 14 days before ischemia . C. zeylanicum was st and ardized through HPLC analysis . Administration of cinnamon bark extract significantly improved ischemia/reperfusion-induced myocardial injury as evidence d by reduction of the infa rct size . Also , during the ischemic period , ventricular tachycardia and ventricular ectopic beats episodes decreased as compared with that of the control group . The extract stabilized the ST segment changes and QTc shortening , decreased R-wave amplitude , and increased heart rate during ischemia . The extract also caused significant elevations in serum superoxide dismutase and glutation proxidase activities as well as a significant decrease in serum cardiac troponin I , lactate dehydrogenase , and malondialdehyde levels , 5 days after reperfusion . In HPLC analysis , the amounts of Cinamic acid , Methyl eugenol , and Cinnamaldehyde were 8.99 ± 0.5 , 13.02 ± 1.8 , and 14.63 ± 1.1 mg/g , respectively . The results show that the ethanolic extract of cinnamon bark is able to protect the heart against ischemia-reperfusion injury probably due to its antioxidant properties . Hence , it might be beneficial in these patients and this remedy might be used for preparation of new drugs"
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BACKGROUND There is uncertainty in deferred active treatment ( DAT ) programmes , regarding patient selection , follow-up and monitoring , reclassification , and which outcome measures should be prioritised . OBJECTIVE To develop consensus statements for all domains of DAT . DESIGN , SETTING , AND PARTICIPANTS A protocol -driven , three phase study was undertaken by the European Association of Urology (EAU)-European Association of Nuclear Medicine (EANM)-European Society for Radiotherapy and Oncology (ESTRO)-European Association of Urology Section of Urological Research (ESUR)-International Society of Geriatric Oncology ( SIOG ) Prostate Cancer Guideline Panel in conjunction with partner organisations , including the following : ( 1 ) a systematic review to describe heterogeneity across all domains ; ( 2 ) a two-round Delphi survey involving a large , international panel of stakeholders , including healthcare practitioners ( HCPs ) and patients ; and ( 3 ) a consensus group meeting attended by stakeholder group representatives . Robust methods regarding what constituted the consensus were strictly followed . RESULTS AND LIMITATIONS A total of 109 HCPs and 16 patients completed both survey rounds . Of 129 statements in the survey , consensus was achieved in 66 ( 51 % ) ; the rest of the statements were discussed and voted on in the consensus meeting by 32 HCPs and three patients , where consensus was achieved in additional 27 statements ( 43 % ) . Overall , 93 statements ( 72 % ) achieved consensus in the project . Some uncertainties remained regarding clinical ly important thresholds for disease extent on biopsy in low-risk disease , and the role of multiparametric magnetic resonance imaging in determining disease stage and aggressiveness as a criterion for inclusion and exclusion . CONCLUSIONS Consensus statements and the findings are expected to guide and inform routine clinical practice and research , until higher levels of evidence emerge through prospect i ve comparative studies and clinical trials . PATIENT SUMMARY We undertook a project aim ed at st and ardising the elements of practice in active surveillance programmes for early localised prostate cancer because currently there is great variation and uncertainty regarding how best to conduct them . The project involved large numbers of healthcare practitioners and patients using a survey and face-to-face meeting , in order to achieve agreement ( ie , consensus ) regarding best practice , which will provide guidance to clinicians and research ers | [
"BACKGROUND The comparative effectiveness of treatments for prostate cancer that is detected by prostate-specific antigen ( PSA ) testing remains uncertain . METHODS We compared active monitoring , radical prostatectomy , and external-beam radiotherapy for the treatment of clinical ly localized prostate cancer . Between 1999 and 2009 , a total of 82,429 men 50 to 69 years of age received a PSA test ; 2664 received a diagnosis of localized prostate cancer , and 1643 agreed to undergo r and omization to active monitoring ( 545 men ) , surgery ( 553 ) , or radiotherapy ( 545 ) . The primary outcome was prostate-cancer mortality at a median of 10 years of follow-up . Secondary outcomes included the rates of disease progression , metastases , and all-cause deaths . RESULTS There were 17 prostate-cancer-specific deaths overall : 8 in the active-monitoring group ( 1.5 deaths per 1000 person-years ; 95 % confidence interval [ CI ] , 0.7 to 3.0 ) , 5 in the surgery group ( 0.9 per 1000 person-years ; 95 % CI , 0.4 to 2.2 ) , and 4 in the radiotherapy group ( 0.7 per 1000 person-years ; 95 % CI , 0.3 to 2.0 ) ; the difference among the groups was not significant ( P=0.48 for the overall comparison ) . In addition , no significant difference was seen among the groups in the number of deaths from any cause ( 169 deaths overall ; P=0.87 for the comparison among the three groups ) . Metastases developed in more men in the active-monitoring group ( 33 men ; 6.3 events per 1000 person-years ; 95 % CI , 4.5 to 8.8 ) than in the surgery group ( 13 men ; 2.4 per 1000 person-years ; 95 % CI , 1.4 to 4.2 ) or the radiotherapy group ( 16 men ; 3.0 per 1000 person-years ; 95 % CI , 1.9 to 4.9 ) ( P=0.004 for the overall comparison ) . Higher rates of disease progression were seen in the active-monitoring group ( 112 men ; 22.9 events per 1000 person-years ; 95 % CI , 19.0 to 27.5 ) than in the surgery group ( 46 men ; 8.9 events per 1000 person-years ; 95 % CI , 6.7 to 11.9 ) or the radiotherapy group ( 46 men ; 9.0 events per 1000 person-years ; 95 % CI , 6.7 to 12.0 ) ( P , prostate-cancer-specific mortality was low irrespective of the treatment assigned , with no significant difference among treatments . Surgery and radiotherapy were associated with lower incidences of disease progression and metastases than was active monitoring . ( Funded by the National Institute for Health Research ; ProtecT Current Controlled Trials number , IS RCT N20141297 ; Clinical Trials.gov number , NCT02044172 . )",
"BACKGROUND The Prostate Cancer Research International Active Surveillance ( PRIAS ) study was initiated a decade ago to study the most optimal selection and follow-up of men on active surveillance ( AS ) . OBJECTIVE We report on 10 yr of follow-up of men on AS in the PRIAS study and evaluate if criteria used to recommend a switch to active treatment truly predict unfavorable outcome on subsequent radical prostatectomy ( RP ) . DESIGN , SETTING , AND PARTICIPANTS Men with low-risk prostate cancer were included and followed prospect ively on AS . Follow-up consisted of regular prostate-specific antigen ( PSA ) tests , digital rectal examinations , and biopsies . Men with Gleason > 3 + 3 , more than two positive biopsy cores , or stage higher than cT2 were advised to switch to active treatment ( until 2014 , a PSA doubling time [ PSA DT ] of 0 - 3 yr was also used ) . OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Reclassification rates , treatment after discontinuation , and outcome on RP after discontinuing AS were reported . Regression analysis on the outcome of RP was used to evaluate the predictive value of criteria currently used to recommend a switch to active treatment . Kaplan-Meier and competing risk analysis were used to report discontinuation rates over time and long-term oncologic end points . RESULTS AND LIMITATIONS A total of 5302 men were included in PRIAS across 18 countries . Reclassification rates remained stable on all subsequent biopsies , with 22 - 33 % of men having either Gleason > 3 + 3 or more than two positive cores on any repeat biopsy . At 5 and 10 yr of follow-up , 52 % and 73 % of men , respectively , had discontinued AS , most of them because of protocol -based reclassification . A third of men undergoing subsequent RP had favorable pathologic tumor features ( Gleason 3 + 3 and pT2 ) . Of the criteria used to recommend a switch to active treatment , more than two positive cores and a PSA DT of 0 - 3 yr were not predictive of unfavorable pathologic outcome on RP . CONCLUSIONS A substantial group of men discontinued AS without subsequent unfavorable tumor features on RP ; therefore , we propose Gleason upgrading and cT3 as the only indicators for an immediate switch to active treatment . Surrogate indicators ( eg , more than two positive cores and a fast-rising PSA ) should not trigger immediate active treatment but rather further investigation to confirm the suspicion of higher risk disease . PATIENT SUMMARY We confirmed the safety of active surveillance as a treatment option for men with low-risk prostate cancer ; however , some changes could be made to the follow-up protocol to safely increase the number of men who remain on active surveillance ",
"Background Colorectal cancer ( CRC ) is a major cause of worldwide morbidity and mortality . Surgical treatment is common , and there is a great need to improve the delivery of such care . The gold st and ard for evaluating surgery is within well- design ed r and omized controlled trials ( RCTs ) ; however , the impact of RCTs is diminished by a lack of coordinated outcome measurement and reporting . A solution to these issues is to develop an agreed st and ard “ core ” set of outcomes to be measured in all trials to facilitate cross- study comparisons , meta- analysis , and minimize outcome reporting bias . This study defines a core outcome set for CRC surgery . Methods and Findings The scope of this COS includes clinical effectiveness trials of surgical interventions for colorectal cancer . Excluded were nonsurgical oncological interventions . Potential outcomes of importance to patients and professionals were identified through systematic literature review s and patient interviews . All outcomes were transcribed verbatim and categorized into domains by two independent research ers . This informed a question naire survey that asked stakeholders ( patients and professionals ) from United Kingdom CRC centers to rate the importance of each domain . Respondents were resurveyed following group feedback ( Delphi methods ) . Outcomes rated as less important were discarded after each survey round according to predefined criteria , and remaining outcomes were considered at three consensus meetings ; two involving international professionals and a separate one with patients . A modified nominal group technique was used to gain the final consensus . Data sources identified 1,216 outcomes of CRC surgery that informed a 91 domain question naire . First round question naires were returned from 63 out of 81 ( 78 % ) centers , including 90 professionals , and 97 out of 267 ( 35 % ) patients . Second round response rates were high for all stakeholders ( > 80 % ) . Analysis of responses lead to 45 and 23 outcome domains being retained after the first and second surveys , respectively . Consensus meetings generated agreement on a 12 domain COS . This constituted five perioperative outcome domains ( including anastomotic leak ) , four quality of life outcome domains ( including fecal urgency and incontinence ) , and three oncological outcome domains ( including long-term survival ) . Conclusion This study used robust consensus methodology to develop a core outcome set for use in colorectal cancer surgical trials . It is now necessary to vali date the use of this set in research practice",
"OBJECTIVES The objective of the study was to explore the impact of different feedback strategies on ( 1 ) subsequent agreement and ( 2 ) variability in Delphi studies . STUDY DESIGN AND SETTING A two-round Delphi survey , with a list of outcomes generated from the results of a systematic review and interviews , was undertaken while developing a core outcomes set for prostate cancer including two stakeholder groups ( health professionals and patients ) . Seventy-nine outcomes were scored on a scale of one ( not important ) to nine ( critically important ) . Participants were r and omized in round 2 to receive round 1 feedback from peers only , multiple stakeholders separately , or multiple stakeholders combined . RESULTS Agreement on outcomes retained for all feedback groups was high ( peer : 92 % , multiple separate : 90 % , multiple combined : 84 % ) . There were no statistically significant reduction in variability for peer vs. multiple separate ( 0.016 [ -0.035 , 0.067 ] ; P = 0.529 ) , or multiple separate vs. multiple combined feedback ( 0.063 [ -0.003 , 0.129 ] ; P = 0.062 ) . Peer feedback statistically significantly reduced variability compared with multiple combined feedback ( 0.079 [ 0.001 , 0.157 ] ; P = 0.046 ) . CONCLUSIONS We found no evidence of a difference between different feedback strategies in terms of the number of outcomes retained or reduction in variability of opinion . However , this may be explained by the high level of existing agreement in round 1 . Further method ological studies nested within Delphi surveys will help clarify the best strategy",
"BACKGROUND We previously found no significant differences in mortality between men who underwent surgery for localized prostate cancer and those who were treated with observation only . Uncertainty persists regarding nonfatal health outcomes and long‐term mortality . METHODS From November 1994 through January 2002 , we r and omly assigned 731 men with localized prostate cancer to radical prostatectomy or observation . We extended follow‐up through August 2014 for our primary outcome , all‐cause mortality , and the main secondary outcome , prostate‐cancer mortality . We describe disease progression , treatments received , and patient‐reported outcomes through January 2010 ( original follow‐up ) . RESULTS During 19.5 years of follow‐up ( median , 12.7 years ) , death occurred in 223 of 364 men ( 61.3 % ) assigned to surgery and in 245 of 367 ( 66.8 % ) assigned to observation ( absolute difference in risk , 5.5 percentage points ; 95 % confidence interval [ CI ] , ‐1.5 to 12.4 ; hazard ratio , 0.84 ; 95 % CI , 0.70 to 1.01 ; P=0.06 ) . Death attributed to prostate cancer or treatment occurred in 27 men ( 7.4 % ) assigned to surgery and in 42 men ( 11.4 % ) assigned to observation ( absolute difference in risk , 4.0 percentage points ; 95 % CI , ‐0.2 to 8.3 ; hazard ratio , 0.63 ; 95 % CI , 0.39 to 1.02 ; P=0.06 ) . Surgery may have been associated with lower all‐cause mortality than observation among men with intermediate‐risk disease ( absolute difference , 14.5 percentage points ; 95 % CI , 2.8 to 25.6 ) but not among those with low‐risk disease ( absolute difference , 0.7 percentage points ; 95 % CI , ‐10.5 to 11.8 ) or high‐risk disease ( absolute difference , 2.3 percentage points ; 95 % CI , ‐11.5 to 16.1 ) ( P=0.08 for interaction ) . Treatment for disease progression was less frequent with surgery than with observation ( absolute difference , 26.2 percentage points ; 95 % CI , 19.0 to 32.9 ) ; treatment was primarily for asymptomatic , local , or biochemical ( prostate‐specific antigen ) progression . Urinary incontinence and erectile and sexual dysfunction were each greater with surgery than with observation through 10 years . Disease‐related or treatment‐related limitations in activities of daily living were greater with surgery than with observation through 2 years . CONCLUSIONS After nearly 20 years of follow‐up among men with localized prostate cancer , surgery was not associated with significantly lower all‐cause or prostate‐cancer mortality than observation . Surgery was associated with a higher frequency of adverse events than observation but a lower frequency of treatment for disease progression , mostly for asymptomatic , local , or biochemical progression . ( Funded by the Department of Veterans Affairs and others ; PIVOT Clinical Trials.gov number , NCT00007644 .",
"BACKGROUND Overdiagnosis and subsequent overtreatment are important side effects of screening for , and early detection of , prostate cancer ( PCa ) . Active surveillance ( AS ) is of growing interest as an alternative to radical treatment of low-risk PCa . OBJECTIVE To up date our experience in the largest worldwide prospect i ve AS cohort . DESIGN , SETTING , AND PARTICIPANTS Eligible patients had clinical stage T1/T2 PCa , prostate-specific antigen ( PSA ) ≤ 10 ng/ml , PSA density PSA was measured every 3 - 6 mo , and volume-based repeat biopsies were scheduled after 1 , 4 , and 7 yr . Reclassification was defined as more than two positive cores or Gleason > 6 at repeat biopsy . Recommendation for treatment was triggered in case of PSA doubling time Multivariate regression analysis was used to evaluate predictors for reclassification at repeat biopsy . Active therapy-free survival ( ATFS ) was assessed with a Kaplan-Meier analysis , and Cox regression was used to evaluate the association of clinical characteristics with active therapy over time . RESULTS AND LIMITATIONS In total , 2494 patients were included and followed for a median of 1.6 yr . One or more repeat biopsies were performed in 1480 men , of whom 415 men ( 28 % ) showed reclassification . Compliance with the first repeat biopsy was estimated to be 81 % . During follow-up , 527 patients ( 21.1 % ) underwent active therapy . ATFS at 2 yr was 77.3 % . The strongest predictors for reclassification and switching to deferred treatment were the number of positive cores ( two cores compared with one core ) and PSA density . The disease-specific survival rate was 100 % . Follow-up was too short to draw definitive conclusions about the safety of AS . CONCLUSIONS Our short-term data support AS as a feasible strategy to reduce overtreatment . Clinical characteristics and PSA kinetics during follow-up can be used for risk stratification . Strict monitoring is even more essential in men with high-risk features to enable timely recognition of potentially aggressive disease and offer curative intervention . Limitations of using surrogate end points and markers in AS should be recognized . TRIAL REGISTRATION The current program is registered at the Dutch Trial Register with ID NTR1718 ( http://www.trialregister.nl/trialreg/admin/ rct view.asp?TC=1718 )"
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Objective : To summarize the current evidence on the effects of preoperative exercise therapy in patients awaiting invasive surgery on postoperative complication rate and length of hospital stay . Data sources : A primary search of relevant key terms was conducted in the electronic data bases of PubMed , EMBASE , PEDro and CINAHL . Review methods : Studies were included if they were controlled trials evaluating the effects of preoperative exercise therapy on postoperative complication rate and length of hospital stay . The method ological quality of included studies was independently assessed by two review ers using the PEDro scale . Statistical pooling was performed when studies were comparable in terms of patient population and outcome measures . Results were separately described if pooling was not possible . Results : Twelve studies of patients undergoing joint replacement , cardiac or abdominal surgery were included . The PEDro scores ranged from 4 to 8 points . Preoperative exercise therapy consisting of inspiratory muscle training or exercise training prior to cardiac or abdominal surgery led to a shorter hospital stay and reduced postoperative complication rates . By contrast , length of hospital stay and complication rates of patients after joint replacement surgery were not significantly affected by preoperative exercise therapy consisting of strength and /or mobility training . Conclusion : Preoperative exercise therapy can be effective for reducing postoperative complication rates and length of hospital stay after cardiac or abdominal surgery . More research on the utility of preoperative exercise therapy and its long-term effects is needed as well as insight in the benefits of using risk models | [
"One hundred twenty patients undergoing coronary artery surgery completed a r and omized controlled study design ed to investigate whether prophylactic chest physiotherapy affected the incidence of postoperative pulmonary complications . Group 1 patients received no preoperative or postoperative chest physiotherapy . Group 2 patients received preoperative education and instruction in breathing and coughing exercises and postoperative supervision and assistance in performing the same . These exercises were supervised by a physiotherapist twice per day on the first 2 postoperative days and once per day on the 3rd and 4th postoperative days . Physiotherapy for group 3 patients was the same as for group 2 patients except that patients were seen by a physiotherapist 4 times per day on the first 2 postoperative days and twice per day on the 3rd and 4th postoperative days . Group 2 and 3 patients were instructed to practice breathing and coughing exercises every hour . Overall , an incidence of clinical ly significant postoperative pulmonary complications of 7.5 percent was demonstrated . In general , these patients demonstrated lower levels of preoperative pulmonary function and very low early postoperative oxygenation compared with those who did not develop pulmonary complications . There was no indication that the incidence or severity of fever , hypoxemia , chest roentgenologic abnormalities or clinical ly significant postoperative pulmonary complications was different between groups . These results suggest that the necessity for prophylactic chest physiotherapy after routine coronary artery surgery should be review ed",
"The prediction of postoperative pulmonary complications is an underinvestigated field . We conducted a prospect i ve cohort study ( with postoperative pulmonary complications ascertained by an investigator blinded to perioperative variables ) to determine the risk factors for pulmonary complications after elective nonthoracic surgery . Of 1,055 consecutive patients attending the Pre-Admission Clinic of a university hospital ( mean age 55 years , 50 % men , 15 % with history of obstructive airways disease ) , 28 ( 2.7 % ) suffered a postoperative pulmonary complication within 7 days of surgery : 13 patients developed respiratory failure requiring ventilatory support , 9 pneumonia , 5 atelectasis requiring bronchoscopic intervention , and 1 pneumothorax requiring intervention . Mean lengths of stay were substantially prolonged for those patients who developed pulmonary complications within 7 days of surgery : 27.9 days versus 4.5 days , p = 0.006 . Eight variables were statistically significantly associated with pulmonary complications on bivariate analyses . Multivariate analyses revealed that four were independently associated with increased risk of pulmonary complications : age ( odds ratio [ OR ] 5.9 for age > /= 65 years , p positive cough test ( OR 3.8 , P = 0.01 ) , perioperative nasogastric tube ( OR 7.7 , p duration of anesthesia ( OR 3.3 for operations lasting at least 2.5 hours , p = 0.008 ) . Thus , several perioperative factors predict an increased risk for pulmonary complications after elective nonthoracic surgery",
"Evidence -based practice involves the use of evidence from systematic review s and r and omised controlled trials , but the extent of this evidence in physiotherapy has not previously been surveyed . The aim of this survey is to describe the quantity and quality of r and omised controlled trials and the quantity of systematic review s relevant to physiotherapy . The Physiotherapy Evidence Data base ( PEDro ) was search ed . The quality of trials was assessed with the PEDro scale . The search identified a total of 2,376 r and omised controlled trials and 332 systematic review s. The first trial was published in 1955 and the first review was published in 1982 . Since that time , the number of trials and review s has grown exponentially . The mean PEDro quality score has increased from 2.8 in trials published between 1955 and 1959 to 5.0 for trials published between 1995 and 1999 . There is a substantial body of evidence about the effects of physiotherapy . However , there remains scope for improvements in the quality of the conduct and reporting of clinical trials",
"The role of pre-operative short-term pulmonary rehabilitation in patients with chronic obstructive pulmonary disease who undergo coronary artery bypass graft surgery has been assessed for the first time prospect ively . Forty-five patients posted for coronary artery bypass graft surgery were r and omised to receive either short-term pulmonary rehabilitation ( group I ) or no such programme ( group II ) . Patients of both the groups were evenly matched with respect to age , sex , body surface area , duration and severity of chronic obstructive pulmonary disease and coronary artery disease . Normal individuals who evenly matched with the study group were assessed for normal respiratory function parameters . Pre-operative and post-operative peak expiratory flow rate , inspiratory capacity , post-operative ventilation time , post-operative pulmonary complication and hospital stay were determined in both the groups . Peak expiratory flow rate ( 220.0 + /- 12.9 and 324.3 + /- 84.3 in group I , 218.0 + /- 16.4 and 260.5 + /- 35.2 in group II ) and inspiratory capacity ( 844.0 + /- 147.4 and 1100.0 + /- 158.1 in group I , 830.0 + /- 117.4 and 1090 + /- 137 in group II ) were significantly lower before and after surgery respectively in both groups compared to normal values . Even though both groups showed a significant rise in post-operative peak expiratory flow rate and inspiratory capacity after surgery , the post-operative peak expiratory flow rate and inspiratory capacity in group I was significantly higher than in group II . In group I , the post-operative ventilation time ( 24.5 + /- 6.00 hours ) , post-operative complications ( n = 4 ) and hospital stay ( 12.4 + /- 3.6 days ) were significantly lower than in group II ( 35.2 + /- 22.3 hours , n = 11 , 18.8 + /- 6.6 days respectively ) . These data suggest that short-term pulmonary rehabilitation is feasible and effective in improving pulmonary functions before and after surgery and in reducing surgical morbidity and cost of medical care significantly",
"BACKGROUND Peak oxygen uptake ( Vo(2peak ) ) strongly predicts mortality in cardiac patients . We compared the effects of aerobic interval training ( AIT ) versus moderate continuous training ( MCT ) on Vo(2peak ) and quality of life after coronary artery bypass grafting ( CABG ) . METHODS Fifty-nine CABG patients were r and omized to either AIT at 90 % of maximum heart rate or MCT at 70 % of maximum heart rate , 5 d/wk , for 4 weeks at a rehabilitation center . Primary outcome was Vo(2peak ) , at baseline , after rehabilitation ( 4 weeks ) , and after 6 months of home-based exercise ( 6 months ) . RESULTS Vo(2peak ) increased between baseline and 4 weeks in AIT ( 27.1 + /- 4.5 vs 30.4 + /- 5.5 mL.kg(-1).min(-1 ) , P MCT ( 26.2 + /- 5.2 vs 28.5 + /- 5.6 mL.kg(-1).min(-1 ) , P Aerobic interval training increased Vo(2peak ) between 4 weeks and 6 months ( 30.4 + /- 5.5 vs 32.2 + /- 7.0 mL.kg(-1).min(-1 ) , P MCT ( 28.5 + /- 5.6 vs 29.5 + /- 5.7 mL.kg(-1).min(-1 ) ) . Quality of life improved in both groups from baseline to 4 weeks , remaining improved at 6 months . There were no changes in echocardiographic systolic and diastolic left ventricular function . Adiponectin increased between 4 weeks and 6 months in both groups ( group differences , not significant ) . CONCLUSIONS Four weeks of intense training increased Vo(2peak ) significantly after both AIT and MCT . Six months later , the AIT group had a significantly higher Vo(2peak ) than MCT . The results indicate that AIT and MCT increase Vo(2peak ) similarly in the short term , but with better long-term effect of AIT after CABG",
"BACKGROUND The impact of short-term preoperative pulmonary rehabilitation on exercise capacity of patients with chronic obstructive pulmonary disease undergoing lobectomy for non-small cell lung cancer is evaluated . METHODS A prospect i ve observational study was design ed . Inclusion criteria consisted of an indication to lung resection because of a clinical stage I or II non-small cell lung cancer and a chronic obstructive disease on preoperative pulmonary function test . In such conditions , maximal oxygen consumption by a cardio-pulmonary exercise test was evaluated ; when this result ed as being pulmonary rehabilitation programme lasting 4 weeks was considered . Twelve patients fulfilled inclusion criteria , completed the preoperative rehabilitation programme and underwent a new functional evaluation prior to surgery . The postoperative record of these patients was collected . RESULTS On completion of pulmonary rehabilitation , the resting pulmonary function test and diffuse lung capacity of patients was unchanged , whereas the exercise performance was found to have significantly improved ; the mean increase in maximal oxygen consumption proved to be at 2.8 ml/kg/min ( p Eleven patients underwent lobectomy ; no postoperative mortality was noted and mean hospital stay was 17 days . Postoperative pulmonary complication was recorded in 8 patients . CONCLUSIONS Short-term preoperative pulmonary rehabilitation could improve the exercise capacity of patients with chronic obstructive pulmonary disease who are c and i date s for lung resection for non-small cell lung cancer",
"OBJECTIVE To evaluate the effects of st and ardized western acupuncture and physiotherapy on pain and functional ability in patients with severe osteoarthritic knee pain awaiting knee arthroplasty . METHODS Three-arm , assessor-blind , r and omized controlled trial . PARTICIPANTS 181 patients awaiting knee arthroplasty . INTERVENTIONS acupuncture for 6 weeks ; physiotherapy for 6 weeks ; st and ardized advice . MAIN OUTCOME MEASURES Oxford Knee Score question naire ( OKS ) ( primary ) ; 50 m timed walk , and duration of hospital stay following knee arthroplasty . RESULTS There was no baseline difference between groups . At 7 weeks , there was a 10 % reduction in OKS in the acupuncture group which was a significant difference between the acupuncture and the control group : Mean ( s.d . ) acupuncture 36.8 ( 7.20 ) ; physiotherapy 39.2 ( 8.22 ) ; control 40.3 ( 8.48 ) ( P = 0.0497 ) . These effects were no longer present at 12 weeks . There was a trend ( P = 0.0984 ) towards a shorter in-patient stay of 1 day for the physiotherapy group [ mean 6.50 days ( s.d . 2.0 ) ] compared with the acupuncture group [ mean 7.77 days ( s.d . 3.96 ) ] . CONCLUSIONS We have demonstrated that patients with severe knee osteoarthritis can achieve a short-term reduction in OKS when treated with acupuncture . However , we failed to demonstrate any other clinical ly or statically significant effects between the groups . Both interventions can be delivered effectively in an out-patient group setting at a district general hospital . Further study is needed to evaluate the combined effects of these treatments",
"Backround . The purpose of the trial was to evaluate the effect on length of stay of individually tailored rehabilitation for clients who were undergoing hip or knee arthroplasty . Method . Clients ( n = 133 ) with complex needs ( comorbid conditions or limited social support ) were r and omly assigned to receive preoperative usual care ( UC ) or rehabilitation ( R ) . Usual care clients received a single preoperative clinic visit . Rehabilitation clients were individually assessed and received multi disciplinary rehabilitation to optimize functional capacity , education about the in-hospital phase and early discharge planning . All rehabilitation subjects received interdisciplinary counseling/education focused on preparation for discharge home . The intervention for approximately half the rehabilitation clients was a single , cost-effective session , while others received physical conditioning . Results . Clients receiving rehabilitation achieved discharge criteria earlier ( R = 5.4 , UC = 8 days ) and had a shorter actual length of stay ( R = 6.5 , UC = 10.5 days ) . Clinical Implication s. This preoperative , individually tailored , rehabilitation program reduced length of stay",
"OBJECTIVE We evaluated the usefulness of analyzing expired gas during exercise testing for the prediction of postoperative cardiopulmonary complications in patients with esophageal carcinoma . BACKGROUND DATA Radical esophagectomy with 3-field lymphadenectomy is performed in patients with thoracic esophageal carcinoma but has a high risk of postoperative complications . To reduce the surgical risk , we performed preoperative risk analysis using 8 factors . Although hospital mortality was decreased when this risk analysis was used , severe cardiopulmonary complications still occurred . METHODS The study group consisted of 91 patients who had undergone curative esophagectomy with 3-field lymphadenectomy . The maximum oxygen uptake , anaerobic threshold , vital capacity , percent vital capacity , forced expiratory volume in 1 second , percent forced expiratory volume , V.(25)/HT , forced expired flow at 75 % of forced vital capacity to height ratio ( FEF(75%)/HT ) , forced expired flow at 50 % to 75 % of forced vital capacity ratio ( FEF(50%)/FEF(75 % ) ) , percent diffusion capacity for carbon monoxide , and arterial oxygen tension were measured . Patients were divided into 2 groups on the basis of the presence or absence of postoperative cardiopulmonary complications . RESULTS Only the maximum oxygen uptake was significantly different between the 2 groups . All patients were grouped according to the value of the maximum oxygen uptake , and the occurrence of postoperative cardiopulmonary complications was calculated for each group . A cardiopulmonary complication rate of 86 % was found for patients with a maximum oxygen uptake of less than 699 mL. min(-1 ) . m(-2 ) ; for those with a value of 700 to 799 mL. min(-1 ) . m(-2 ) , the complication rate was 44 % . CONCLUSIONS The maximum oxygen uptake obtained by expired gas analysis during exercise testing correlates with the postoperative cardiopulmonary complication rate . On the basis of these results , esophagectomy with 3-field lymphadenectomy can be safely performed in patients with a maximum oxygen uptake of at least 800 mL. min(-1 ) . m(-2 )",
"Objective : To investigate the effects of preoperative physical therapy for patients undergoing total hip replacement . Design : Prospect i ve r and omized controlled study . Setting : Department of Orthopaedics and Traumatology in a university hospital . Subjects : Sixty patients with osteoarthritis of the hip scheduled to receive total hip replacement were r and omly assigned into two groups . Interventions : Subjects in the study group received preoperative physiotherapy design ed to strengthen the muscles of the upper and lower limbs and to improve range of motion of the hip , beginning from eight weeks before the operation . These patients also received an educational programme about living with a prosthesis . The control group received no preoperative physiotherapy or educational programme . Main outcome measures : Patients were evaluated at baseline ( study group only , eight weeks prior to operation ) , before surgery , at discharge , three months and two years postoperatively using Harris Hip Score , visual analogue scale and range at hip abduction . Results : Although patients in the study group performed transfer activities earlier than the control group , there were no significant differences between the groups at discharge with regard to the improvement in Harris Hip Score ( p hip adduction ( p visual analogue scale at rest ( p activity ( p Harris Hip Score , but rate of improvement between the groups was similar ( p physiotherapy and education programme is not useful in total hip replacement surgery",
"OBJECTIVE To determine the effectiveness of a preoperative exercise/education program on functional recovery , health related quality of life ( HRQOL ) , health service utilization , and costs following primary total knee arthroplasty ( TKA ) . METHODS One hundred thirty-one subjects were r and omized to either the control ( n = 66 ) or treatment ( n = 65 ) group 6 weeks before TKA surgery . Patients in the treatment group underwent a 4-week exercise/education program before surgery . All subjects were assessed 6 weeks preoperatively ( before the exercise/education intervention ) , immediately preoperatively ( after the exercise/education intervention ) , and 3 , 6 and 12 months after surgery utilizing the Western Ontario McMaster Osteoarthritis Index , the SF-36 , and knee range of motion ( ROM ) and strength measures . Data on length of stay , numbers of community rehabilitation or homecare visits following discharge from the surgical hospital , and the costs associated with these services were also collected . RESULTS Subjects were similar in demographic characteristics and all measurements at the baseline assessment . No differences were seen in knee measurements ( ROM and strength ) , pain , function , or HRQOL between the 2 groups following the intervention program or at any postoperative measurement point . Patients in the treatment group used fewer postoperative rehabilitation services and stayed for a shorter time in hospital than the control group , but these differences did not attain statistical significance . CONCLUSION The exercise/education intervention did not alter functional recovery or HRQOL following TKA . Health service utilization was less in the treatment group , but our study was underpowered to attain statistical significance for these measures",
"Surgical patients often show physiological and metabolic distress , muscle weakness , and long hospital stays . Physical conditioning might help recovery . We attempted to identify the most responsive measure of aerobic fitness from a four-week pre-surgical aerobic exercise program ( prehabilitation ) in patients undergoing major bowel resection . Twenty-one subjects r and omized two to one ( exercise : control ) scheduled for colorectal surgery . Fourteen subjects [ Body Mass Index ( BMI ) = 27 + /- 6 kg/m(2 ) ; maximal oxygen uptake ( VO(2max ) ) = 22 + /- 10 ml/kg/min ] underwent 3.8 + /- 1.2 weeks ( 27 + /- 8 sessions ) of progressive , structured pre-surgical aerobic exercise training at 40 to 65 % of heart rate reserve ( % HRR ) . Peak power output was the only maximal measure that was responsive to training [ 26 + /- 27 % , Effects Size ( ES ) = 0.24 ; St and ardized Response Mean ( SRM ) = 1.05 ; p heart rate and oxygen uptake during submaximal exercise was most responsive to training ( decrease by 13 % + /- 15 % , ES = -0.24 ; SRM = -0.57 ; and 7 % + /- 6 % , ES = -0.40 ; SRM -0.97 ; p maximal or submaximal measures in the control group . The distance walked over six minutes improved in both groups ( by approximately 30 m ) , but the effect size and t-statistic were higher in the exercise group . Heart rate and oxygen uptake during submaximal exercise , and peak power output are the most responsive measures to four weeks of prehabilitation in subjects with low initial fitness",
"Although much research has documented the functional outcomes in hip repair surgery , few studies have identified effective interventions to improve functional outcomes . The purpose of this study was to test the use of generic and individualized videos on patients ' return to preoperative levels of independent functioning , increased physical performance , improved coping ability , and enhanced perception of ability to care for self . Two rehabilitation units in separate acute care facilities were used to recruit subjects . Data were collected on 82 participants on admission to the study , on discharge from rehabilitation , 1 week after discharge , and 3 months post discharge . The results indicate that video intervention has some benefit to persons recovering from hip repair surgery . The benefits were realized in physical performance as evidence d by a significant difference in the distance walked and time walked of participants in the treatment group",
"BACKGROUND / AIM Hip arthroplasty is a routine operation which relieves pain in patients with osteoarthritis . The role of physical therapy after hip arthroplasty was recognized , but the importance of preoperative physical therapy and education is still to be judged . The aim of this paper was to investigate the effect of short-term preoperative program of education and physical therapy on patients ' early functional recovery immediately after total hip arthroplasty ( THA ) . METHODS This prospect i ve study included 45 patients with hip osteoarthritis scheduled to undergo primary THA and admitted to the Department of Orthopedics of Military Medical Academy . They were r and omized into 2 groups : study and control one ( with and without preoperative education and physical therapy ) . Preoperative education was conducted through conversation ( 1 appointment with physiatrist ) and brochure . The study group was instructed to perform exercises and basic activities from the postoperative rehabilitation program ( 2 practical classes with physiotherapist ) . Effects were measured with question naires ( Harris , Oxford and Japanese Orthopaedic Association ( JOA ) hip scores ) , range of motion and visual analog scale of pain . Marks showing ability to perform basic activities and endurance were from 0 ( did not perform activity ) to 5 ( independent and secure ) . Analyses examined differences between the groups over the preoperative and immediate postoperative periods and 15 months after the operation . RESULTS There were no differences between the groups at discharge according to pain , range of motion , Harris hip score and JOA hip score . Oxford hip score did not differ between the groups 15 months after the operation . The groups started to walk at the same time , but the study group walked up and down stairs ( 3.7+/-1.66 vs 5.37+/-1.46 , p used toilet ( 2.3+/-0.92 vs 3.2+/-1.24 , p chair ( 2.2+/-1.01 vs 3.25+/-1.21 , p independent than the control one while performing any basic activities ( changing position in bed from supine to side lying , from supine to sitting on the edge of the bed , from sitting to st and ing , from st and ing to lying in the bad , st and ing , walking , using toilet and chair ) . At discharge the patients from the control group still needed the therapist help for walking up and down stairs ( 3+/-1.26 ) , while the patients from the study group performed there activities independently ( 4.85+/-0.37 ) ( p Endurance while walking was significantly better in the study group than in the control one . The length of hospital stay after the operation was similar for both groups , but the patients from the study group needed significantly less classes with the therapist ( 5.2+/-2.35 vs 6.85+/-1.14 , p education with the elements of physical therapy accelerated early functional recovery of patients ( younger than 70 ) immediately after THA and we recommend it for routine use",
"Abstract During the recent years improved operation techniques and administrative procedures have been developed for early rehabilitation . At the same time preoperative lifestyle intervention ( prehabilitation ) has revealed a large potential for additional risk reduction . The aim was to assess the quality of life and to estimate the cost-effectiveness of st and ard care versus an integrated programme including prehabilitation and early rehabilitation . Methods The analyses were based on the results from 60 patients undergoing lumbar fusion for degenerative lumbar disease ; 28 patients were r and omised to the integrated programme and 32 to the st and ard care programme . Data on cost and health related quality of life was collected preoperatively , during hospitalisation and postoperatively . The cost was estimated from multiplication of the re source consumption and price per unit . Results Overall there was no difference in health related quality of life scores . The patients from the integrated programme obtained their postoperative milestones sooner , returned to work and soaked less primary care after discharge . The integrated programme was 1,625 € ( direct costs 494 € + indirect costs 1,131 € ) less costly per patient compared to the st and ard care programme . Conclusion The integrated programme of prehabilitation and early rehabilitation in spine surgery is more cost-effective compared to st and ard care programme alone",
"Objective : To determine in a pilot study the feasibility and effects of preoperative inspiratory muscle training in patients at high risk of postoperative pulmonary complications who were scheduled for coronary artery bypass graft surgery . Design : Single-blind , r and omized controlled pilot study . Setting : University Medical Centre Utrecht , the Netherl and s. Subjects : Twenty-six patients at high risk of postoperative pulmonary complications were selected . Intervention : The intervention group ( N = 14 ) received 2 - 4 weeks of preoperative inspiratory muscle training on top of the usual care received by the patients in the control group . Main measures : Primary outcome variables of feasibility were the occurrence of adverse events , and patient satisfaction and motivation . Secondary outcome variables were postoperative pulmonary complications and length of hospital stay . Results : The feasibility of inspiratory muscle training was good and no adverse events were observed . Treatment satisfaction and motivation , scored on 10-point scales , were 7.9 ( ± 0.7 ) and 8.2 ( ± 1.0 ) , respectively . Postoperative atelectasis occurred in significantly fewer patients in the intervention group than in the control group ( ϰ2 DF1 = 3.85 ; P = 0.05 ) : Length of hospital stay was 7.93 ( ± 1.94 ) days in the intervention group and 9.92 ( ± 5.78 ) days in the control group ( P = 0.24 ) . Conclusion : Inspiratory muscle training for 2 - 4 weeks before coronary artery bypass graft surgery was well tolerated by patients at risk of postoperative pulmonary complications and prevented the occurrence of atelectasis in these patients . A larger r and omized clinical trial is warranted",
"Introduction : A stepwise approach to the functional assessment of lung resection c and i date s is widely accepted , and this approach incorporates the measurement of exercise peak Vo2 when spirometry and radionuclear studies suggest medical inoperability . A new functional operability ( FO ) algorithm incorporates peak exercise Vo2 earlier in the preoperative assessment to determine which patients require preoperative radionuclear studies . This algorithm has not been studied in a multicenter study . Methods : The CALGB ( Cancer and Leukemia Group B ) performed a prospect i ve multi-institutional study to investigate the use of primary exercise Vo2 measurement for the prediction of surgical risk . Patients with known or suspected resectable non-small cell lung cancer ( NSCLC ) were eligible . Exercise testing including measurement of peak oxygen uptake ( Vo2 ) , spirometry , and single breath diffusion capacity ( DLCO ) was performed on each patient . Nuclear perfusion scans were obtained on selected high-risk patients . After surgery , morbidity and mortality data were collected and correlated with preoperative data . Mortality and morbidity were retrospectively compared by algorithm-based risk groups . Results : Three hundred forty-six patients with suspected lung cancer from nine institutions underwent thoracotomy with or without resection ; 57 study patients did not undergo thoracotomy . Patients who underwent surgery had a median survival time of 30.9 months , whereas patients who did not undergo surgery had a median survival time of 15.6 months . Among the 346 patients who underwent thoracotomy , 15 patients died postoperatively ( 4 % ) , and 138 patients ( 39 % ) exhibited at least one cardiorespiratory complication postoperatively . We found that patients who had a peak exercise Vo2 of complications ( p = 0.0001 ) and were also more likely to have a poor outcome ( respiratory failure or death ) if the peak Vo2 was 58 patients who did not meet FO algorithm criteria for operability , but who still tolerated lung resection with a 2 % mortality rate . Conclusions : Our data provide multicenter validation for the use of exercise Vo2 for preoperative assessment of lung cancer patients , and we encourage an aggressive approach when evaluating these patients for surgery",
"Summary We evaluated the long-term excess mortality associated with hip fracture , using prospect ively collected data on pre-fracture health and function from a nationally representative sample of U.S. elders . Although mortality was elevated for the first six months following hip fracture , we found no evidence of long-term excess mortality . Introduction The long-term excess mortality associated with hip fracture remains controversial . Methods To assess the association between hip fracture and mortality , we used prospect ively collected data on pre-fracture health and function from a representative sample of U.S. elders in the Medicare Current Beneficiary Survey ( MCBS ) to perform survival analyses with time-varying covariates . Results Among 25,178 MCBS participants followed for a median duration of 3.8 years , 730 sustained a hip fracture during follow-up . Both early ( within 6 months ) and subsequent mortality showed significant elevations in models adjusted only for age , sex and race . With additional adjustment for pre-fracture health status , functional impairments , comorbid conditions and socioeconomic status , however , increased mortality was limited to the first six months after fracture ( hazard ratio [ HR ] : 6.28 , 95 % CI : 4.82 , 8.19 ) . No increased mortality was evident during subsequent follow-up ( HR : 1.04 , 95 % CI : 0.88 , 1.23 ) . Hip-fracture-attributable population mortality ranged from 0.5 % at age 65 among men to 6 % at age 85 among women . Conclusions Hip fracture was associated with substantially increased mortality , but much of the short-term risk and all of the long-term risk was explained by the greater frailty of those experiencing hip fracture",
"Wang AW , Gilbey HJ , Ackl and TR : Perioperative exercise programs improve early return of ambulatory function after total hip arthroplasty : A r and omized , controlled trial . Am J Phys Med Rehabil 2002;81:801–806 . Objective Patients with endstage hip arthritis have poor ambulatory function . The aim of this study was to determine if perioperative exercise programs are well tolerated by these elderly patients and if a customized program can achieve an earlier recovery of normal ambulatory function after total hip arthroplasty . Design Twenty-eight subjects scheduled for total hip arthroplasty were r and omized to either the exercise group and received a perioperative customized exercise program or the control group and received the routine perioperative care . Ambulatory function was assessed by measurement of gait parameters during a 25-m walk test , and walking endurance was assessed by a 6-min walk test . Results Exercise group subjects attended 97.3 % of scheduled exercise sessions with no training injuries . Exercise group subjects demonstrated greater stride length and gait velocity at 3 wk postsurgery . At 12 and 24 wk postsurgery , gait velocity was greater , and the 6-min walking distance was significantly greater than the control group . Conclusion The study indicates that perioperative customized exercise program are well tolerated in the elderly patient with endstage hip arthritis and are effective in improving the rate of recovery in ambulatory function in the first 6 mo after total hip arthroplasty",
"Objective : To investigate the feasibility and effects of preoperative inspiratory muscle training on the incidence of atelectasis in patients at high risk of postoperative pulmonary complications scheduled for elective abdominal aortic aneurysm surgery . Design : Single-blind r and omized controlled pilot study . Setting : Gelderse Vallei Hospital Ede , the Netherl and s. Subjects : Twenty high-risk patients undergoing elective abdominal aortic aneurysm surgery were r and omly assigned to receive preoperative inspiratory muscle training or usual care . Main measures : Effectiveness outcome variables were atelectasis , inspiratory muscle strength and vital capacity , and feasibility outcome variables were adverse effects and patient satisfaction with inspiratory muscle training . Results : Despite r and omization , patients in the intervention group were significantly older than the patients in the control group ( 70 ± 6 years versus 59 ± 6 years , respectively ; P = 0.001 ) . Eight patients in the control group and three in the intervention group developed atelectasis ( P = 0.07 ) . The median duration of atelectasis was 0 days in the intervention group and 1.5 days in the control group ( P = 0.07 ) . No adverse effects of preoperative inspiratory muscle training were observed and patients considered that inspiratory muscle training was a good preparation for surgery . Mean postoperative inspiratory pressure was 10 % higher in the intervention group . Conclusion : Preoperative inspiratory muscle training is well tolerated and appreciated and seems to reduce the incidence of atelectasis in patients scheduled for elective abdominal aortic aneurysm surgery",
"OBJECTIVE To evaluate the occurrence and risk of pulmonary complications in children who underwent pre- and postoperative physiotherapeutic intervention in cardiac surgeries , as well as to compare these patients to those who underwent only postoperative physiotherapeutic intervention . METHODS A r and omized controlled trial was performed with 135 patients from 6 years of age and younger with congenital heart disease who had undergone cardiac surgery . Patients were r and omly assigned to the intervention group ( G1 ) in which they underwent pre- and postoperative physiotherapy or to the control group ( G2 ) in which they underwent only postoperative physiotherapy . Mann-Whitney and the Chi-square tests were used to compare the variables between the groups . The magnitude of the absolute risk was calculated by the number of patients needed to treat . Statistical significance was set at 5 % ( P pulmonary complications ( P= 0.025 ) , pneumonia was the most frequent complication , and among the 17 patients in G1 , seven ( 10.3 % ) developed pneumonia , six ( 8.8 % ) developed atelectasis , and four ( 5.9 % ) presented complications due to both complications . In G2 , 13 patients ( 19.4 % ) developed pneumonia , eight ( 11.9 % ) developed atelectasis , and eight ( 11.9 % ) developed pneumonia associated with atelectasis . Absolute risk reduction for the primary outcome was of 18.3 % and the number of needed to treat was 5.5 . CONCLUSION Preoperative respiratory physiotherapy significantly reduced the risk of pulmonary complications in postoperative pediatric cardiac surgery",
"Introduction This r and omized controlled study evaluated the clinical benefit and physiological effects of prophylactic chest physiotherapy in open major abdominal surgery",
"Objective : To examine the effect of pre-operative physiotherapy before hip arthroplasty in patients with end-stage hip osteoarthritis . Design : A prospect i ve r and omized controlled study . Setting : Physical medicine and rehabilitation and orthopaedic departments of Policlinico Gemelli of Rome . Subjects : Twenty-three patients r and omized in study and control groups . Intervention : The study group took part in an educational and physiotherapy programme one month before surgery . Both groups took part in the same inpatient rehabilitation programme after surgery . Main outcome measures : Both groups were evaluated one month ( T0 ) and the day before arthroplasty ( T1 ) , after 15 days ( T2 ) , four weeks ( T3 ) and three months ( T4 ) post surgery , using the Barthel Index , the Short Form-36 ( SF-36 ) , the Western Ontario and McMaster Osteoarthritis Index ( WOMAC ) , the Hip Harris Score ( HHS ) , visual analogue scale ( VAS ) , the British Medical Research Council ( BMRC ) measures of hip abductor and quadriceps strength and range of hip abduction and external rotation . Results : There were no significant differences between groups with regard to the Barthel Index , SF-36 , WOMAC and HHS at T4 . The study group presented significant improvements of the SF-36 physical composite score at T1 . The hip external rotation was significantly higher in the study group at each evaluation and the visual analogue scale values were lower at T1 , T3 and T4 . Conclusion : Pre-operative physiotherapy in patients undergoing hip arthroplasty does not improve impairment and health-related quality of life after intervention . Physiotherapy and educational therapy may be useful for end-stage osteoarthritis",
"Herdy AH , Marcchi PLB , Vila A , Tavares C , Collaço J , Niebauer J , Ribeiro JP : Pre- and postoperative cardiopulmonary rehabilitation in hospitalized patients undergoing coronary artery bypass surgery : a r and omized controlled trial . Am J Phys Med Rehabil 2008;87:714–719 . Objective : Patients who have to wait in the hospital for coronary artery bypass surgery ( CABG ) are exposed to the potential risks of immobilization . This clinical trial was conducted to evaluate the effects of an in-hospital cardiopulmonary rehabilitation program performed before and after CABG on postoperative outcomes . Design : Fifty-six patients who had to wait for CABG in-hospital were r and omly assigned to a cardiopulmonary rehabilitation ( Rehab ; n = 29 ) or to usual care ( Control ; n = 27 ) . In the Rehab group , intervention lasted for at least 5 days preoperatively until discharge . The program consisted of phase I cardiac rehabilitation associated with respiratory physical therapy . Outcomes were blindly evaluated . Results : By hospital discharge , Rehab patients presented a shorter time to endotracheal extubation ( 1054 ± 376 vs. 1340 ± 666 min , P = 0.05 ) , a reduction in the incidence of pleural effusion ( relative risk [ RR ] = 0.2 ; 95 % confidence interval [ CI ] : 0.5–0.8 ) , atelectasis ( RR = 0.15 ; 95 % CI : 0.03–0.8 ) , pneumonia ( 0 vs. 7 cases , [ P = 0.004 ] ) , and atrial fibrillation or flutter ( RR = 0.2 ; 95 % CI : 0.05–0.8 ) . Length of in-hospital stay after surgery was also reduced in the Rehab group ( 5.9 ± 1.1 vs. 10.3 ± 4.6 days [ P patients who await CABG in the hospital is superior to st and ard care and leads to a reduced rate of postoperative complications and shorter hospital stay ",
"OBJECTIVE The aim of this study was to evaluate the prophylactic efficacy of preoperative physiotherapy , including inspiratory muscle training ( IMT ) , on the incidence of postoperative pulmonary complications ( PPCs ) in high-risk patients scheduled for elective coronary artery bypass grafting ( CABG ) . DESIGN R and omized controlled clinical trial ( www.controlled-trials . com/is rct n17691887 ) . METHOD Of 655 patients referred to a university medical centre in The Netherl and s for elective CABG , 299 met the criteria for being at high risk of developing PPCs . A total of 279 were enrolled and monitored up to discharge from hospital . Patients were r and omly assigned to receive either preoperative IMT ( n=140 ) or usual care ( n=139 ) . Both groups received the same postoperative treatment . RESULTS Both groups were comparable at baseline . Before CABG , 2 control group patients and 1 IMT group patient died . After CABG surgery , PPCs were present in 25 ( 18 % ) of 139 patients in the IMT group and 48 ( 35 % ) of 137 patients in the control group ( OR : 0.52 ; 95 % CI : 0.30 - 0.92 ) . Pneumonia occurred in 9 ( 6.5 % ) of 139 patients in the IMT group and in 22 ( 16.1 % ) of 137 patients in the usual care group ( OR : 0.40 ; 95 % CI : 0.19 - 0.84 ) . Mean duration of postoperative hospitalization was 7 ( range 5 - 41 ) days in the IMT group versus 8 ( range 6 - 70 ) days in the usual care group ( Mann-Whitney test ; Z : -2.42 ; p = 0.015 ) . CONCLUSION Preoperative physiotherapy , including IMT , statistically significantly reduced the incidence ofPPCs and the duration ofpostoperative hospitalization in patients at high risk of developing a pulmonary complication on undergoing CABG",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"The purpose of this study was to analyse the effects of preoperative physiotherapy on pain and function in 39 patients scheduled for unicompartmental prosthetic knee replacement . Nineteen patients were selected at r and om to receive preoperative physiotherapy . The control group received no preoperative therapy . Evaluations were performed 3 months prior to surgery , immediately before and 3 months after operation . Evaluations included : Clinical assessment , measurements of the knee muscle strength , self-selected walking speed and the oxygen cost of walking . Three months before surgery the patients in both groups had similar types and levels of problems . Before surgery patients who had received physiotherapy showed slight improvements in pain , perceived stability of the knee during walking , and faster self-selected and maximal walking speeds compared to the control group , but were unchanged in muscle strength , ROM , and oxygen cost . Three months after surgery pain was significantly decreased in all patients , however , no significant differences were found between the two groups for any variable except muscle strength . This was unchanged compared to preoperative values for patients of the control group while patients who received preoperative physiotherapy showed a decrease in strength . In summary , this study did not disclose any major benefit from the program of preoperative physiotherapy tested",
"BACKGROUND AND OBJECTIVE Pulmonary resection carries a significant morbidity and mortality . The utility of maximal oxygen uptake test ( VO(2)max ) to predict cardiopulmonary complications following major pulmonary resection was evaluated . METHODS Following st and ard preoperative work-up and VO(2)max testing , 55 patients ( 49 male ; mean age 59 years , range 20 - 74 ) underwent major pulmonary surgery : lobectomy ( n = 31 ) , bilobectomy ( n = 6 ) and pneumonectomy ( n = 18 ) . An investigator blinded to the preoperative assessment prospect ively collected data on postoperative cardiopulmonary complications . Patients were divided into two groups according to preoperative VO(2)max and also according to FEV(1 ) . The frequency of postoperative complications in the groups was compared . RESULTS Complications were observed in 19 ( 34.5 % ) patients , 11 of which were pulmonary ( 20 % ) . There were two deaths ( 3.6 % ) , both due to respiratory failure . Preoperative FEV(1 ) failed to predict postoperative respiratory complications . Five of 36 patients with a preoperative FEV(1 ) > 2 L suffered pulmonary complications , compared with six of 19 patients with FEV(1 ) Cardiopulmonary complications were not observed in patients with VO(2)max > 15 mL/kg/min ( n = 27 ) ; however , 11 patients with VO(2)max cardiopulmonary complications ( P < 0.05 ) . CONCLUSION VO(2)max predicts postoperative pulmonary complications following major lung resection , and the risk of complications increases significantly when the preoperative VO(2)max is less than 15 mL/kg/min",
"OBJECTIVE To evaluate the effect of a short preoperative exercise intervention on the functional status , pain , and muscle strength of patients before and after total joint arthroplasty . METHODS A total of 108 men and women scheduled for total hip arthroplasty ( THA ) or total knee arthroplasty ( TKA ) were r and omized to a 6-week exercise or education ( control ) intervention immediately prior to surgery . We assessed outcomes through question naires and performance measures . Analyses examined differences between groups over the preoperative and immediate postoperative periods and at 8 and 26 weeks postsurgery . RESULTS Among THA patients , the exercise intervention was associated with improvements in preoperative Western Ontario and McMaster Universities Osteoarthritis Index function score ( improvement of 2.2 in exercisers versus decline of 3.9 in controls ; P = 0.02 ) and Short Form 36 physical function score ( decline of 0.4 in exercisers versus decline of 14.3 in controls ; P = 0.003 ) . No significant differences were seen in TKA patients . Exercise participation increased muscle strength preoperatively ( 18 % in THA patients and 20 % in TKA patients ) , whereas the control patients had essentially no change in strength ( P > 0.05 for exercise versus education in both THA and TKA groups ) . Exercise participation prior to total joint arthroplasty substantially reduced the risk of discharge to a rehabilitation facility in THA and TKA patients ( adjusted odds ratio 0.27 , 95 % confidence interval 0.074 - 0.998 ) . The intervention had no effects on outcomes 8 and 26 weeks postoperatively . CONCLUSION A 6-week presurgical exercise program can safely improve preoperative functional status and muscle strength levels in persons undergoing THA . Additionally , exercise participation prior to total joint arthroplasty dramatically reduces the odds of inpatient rehabilitation",
"The purpose of this prospect i ve , r and omized study was to apply an 8-week customized exercise program to patients ( Group E ) scheduled for total hip arthroplasty , followed by a postsurgery exercise program , and show the effect on functional recovery compared with control subjects ( Group C ) who received no additional exercise apart from routine in-hospital physical therapy . Strength , range of motion , and physical function tests were completed by 57 patients at Week 8 and Week 1 before surgery and at Weeks 3 , 12 , and 24 postoperatively . No differences between the exercise and control groups were observed at baseline . By 1 week before surgery , patients in Group E had shown significant improvements for Western Ontario and McMaster Universities Osteoarthritis Index ( total score , stiffness , and physical function components ) , and combined hip strength . Patients in Group E had improved hip flexion range of motion in the diseased hip compared with patients in Group C. Significant differences in outcome measures between Group E and Group C were observed throughout the postoperative phase from Weeks 3 to 24 . The current study showed that customized perioperative exercise programs are well tolerated by patients with end-stage hip arthritis , and are effective in improving early recovery of physical function after total hip arthroplasty",
"This study compared the effects of preoperative physical therapy or general cardiovascular conditioning exercises with the routine procedure of no preoperative physical therapy on patients undergoing primary total knee replacement . Thirty patients were r and omly assigned to 1 of 3 groups . Group 1 was the control group . Group 2 participated in a physical therapy program design ed to strengthen the upper and lower limbs and improve knee range of motion . Group 3 participated in a cardiovascular conditioning program , consisting of arm ergometry , cycle ergometry , aquatic exercises , and aerobic activity . All patients were evaluated preoperatively and postoperatively using the Hospital for Special Surgery Knee Rating , the Arthritis Impact Measurement Scale , and the Quality of Well Being instrument . Both experimental groups tolerated their respective exercise protocol s extremely well . All 3 groups showed significant improvement postoperatively as measured by the Hospital for Special Surgery Knee Rating , the Arthritis Impact Measurement Scale and the Quality of Well Being measurement scales . However , neither type of preoperative exercise added to the degree of improvement after surgery at any of the postoperative evaluations",
"OBJECTIVE Dislocation is a well-known complication after total hip arthroplasty ( THA ) , and is the second-highest cause of revision surgery . Our objective was to assess the effect of preoperative patient education on the occurrence of hip dislocation within 6 months after primary THA . METHODS Between 1998 and 2007 , we conducted a prospect i ve cohort study at the Geneva University Hospital Department of Orthopaedic Surgery , including all primary THAs performed via an anterolateral transgluteal approach with the use of a 28-mm diameter head . The preoperative education session was introduced in June 2002 and included advice on muscle strengthening exercises and postoperative restrictions of range of motion as a means of preventing dislocation . The main outcome was the incidence of dislocation within 6 months of surgery . RESULTS A total of 597 patients who underwent 656 THAs between June 2002 and June 2007 participated in the education session , whereas 1,641 patients who underwent 1,945 procedures did not . Forty-six dislocations occurred over the study period , 5 ( 0.8 % ) in participants and 41 ( 2.1 % ) in non participants ( absolute risk reduction 1.3 % ; 95 % confidence interval [ 95 % CI ] 0.4 , 2.3 ) , with the time interval between surgery and dislocation being significantly shorter among participants ( 0.2 versus 1.2 months ) . Non participants had a 2.8 times higher risk of dislocation than participants ( unadjusted odds ratio [ OR ] 2.80 ; 95 % CI 1.10 , 7.13 ) . Adjustment for age , sex , comorbidities , and prior surgery did not change the results ( adjusted OR 2.79 ; 95 % CI 1.09 , 7.15 ) . CONCLUSION Our findings suggest that participation in a preoperative patient education session may reduce the risk of dislocation within 6 months after THA",
"Pulmonary complications after cardiac surgery are a leading cause of postoperative morbidity and mortality . Respiratory muscle weakness may contribute to the postoperative pulmonary abnormalities . We hypothesized that : ( 1 ) there is a decrease in inspiratory muscle strength ( PImax at residual volume ) and endurance ( Pmpeak/PImax ) following coronary artery bypass graft ( CABG ) ; ( 2 ) this weakness is associated with reduced pulmonary function tests ( PFTs ) , impaired gas exchange , and a higher rate of pulmonary complications ; and ( 3 ) prophylactic inspiratory muscle training ( IMT ) can prevent those changes . Eighty-four c and i date s for CABG , with ages ranging from 33 to 82 years , were evaluated prior to operation and r and omized into two groups : 42 patients underwent IMT using a threshold trainer for 30 min/day for 2 weeks , 1 month before operation ( group A ) ; 42 patients served as a control group and underwent sham training ( group B ) . There was a significant decrease in respiratory muscle function , PFTs , and gas exchange in the control group following CABG , whereas these parameters remained similar to those before entering the study in the training group . The differences between the groups were statistically significant . In addition , 11 ( 26 % ) patients in the control group but only 2 ( 5 % ) in the training group needed postsurgical mechanical ventilation longer than 24 hours . CABGs have a significant deteriorating effect on inspiratory muscle function , PFTs , and arterial blood gases . The decrease in these parameters can be prevented by prophylactic inspiratory muscle training , which may also prevent postsurgical pulmonary complications",
"OBJECTIVE The purpose of this study was to examine the effect of a preoperative exercise intervention on knee pain , functional ability , and quadriceps strength among patients with knee osteoarthritis before and after total knee arthroplasty ( TKA ) surgery . DESIGN A repeated- measures design was used to compare 2 groups over 4 data collection points . SETTING AND PATIENTS Community-dwelling subjects with osteoarthritis of the knee who were scheduled for a unilateral TKA were recruited from a single orthopedic surgeon 's office and were r and omized into control ( n = 28 ) or prehab groups ( n = 26 ) . INTERVENTIONS The control patients maintained usual care before their TKA . The exercisers performed prehabilitation exercises , which included resistance training , flexibility , and step training , 3 times per week before their TKA . OUTCOME MEASURES Knee pain , functional ability , quadriceps strength , and strength asymmetry were assessed at baseline ( T1 ) , at 1 week before the patients ' TKA ( T2 ) , and again at 1 ( T3 ) and 3 ( T4 ) months after TKA . RESULTS The exercisers improved their sit-to-st and performance at T2 , whereas the control group did not change their performance of functional tasks and had increased pain at T2 . At T3 the exercisers demonstrated improved sit-to-st and performance . The control patients at T3 exhibited decreases in pain , their 6-minute walk , surgical leg strength and an increase in their nonsurgical leg strength and leg strength asymmetry . At T4 the exercisers improved in their performance of 3 of the 4 functional tasks , decreased all of their pain measures , and increased their surgical and nonsurgical quadriceps strength . At T4 the control group improved their performance on 2 of the 4 functional tasks , decreased all of their pain measures , increased their nonsurgical leg strength , and exhibited greater leg strength asymmetry . CONCLUSION These findings appear to indicate the efficacy of prehabilitation among TKA patients and support the theory of prehabilitation"
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Objective This purpose of this consensus conference was to determine whether surgical atrial fibrillation ( AF ) ablation during cardiac surgery improves clinical and re source outcomes compared with cardiac surgery alone in adults undergoing cardiac surgery for valve or coronary artery bypass grafting . Methods Before the consensus conference , the consensus panel review ed the best available evidence , whereby systematic review s , r and omized trials , and nonr and omized trials were considered in descending order of validity and importance . Evidence -based statements were created , and consensus processes were used to determine the ensuing recommendations . The American Heart Association/American College of Cardiology system was used to label the level of evidence and class of recommendation . Results The consensus panel agreed on the following statements in patients with AF undergoing cardiac surgery concomitant surgical ablation : 1 . Improves the achievement of sinus rhythm at discharge and 1 year ( level A ) ; this effect is sustained up to 5 years ( level B ) . Does not reduce the use of antiarrhythmic drugs at 12 months after surgery ( level A ; 36.0 % vs. 45.4 % ) , although trials were not design ed to answer this question . 2 . Does not increase the requirement for permanent pacemaker implantation ( 4.4 % vs. 4.8 % ; level A ) . 3 . Does not increase the risk of perioperative mortality ( level A ) , stroke ( level A ) , myocardial infa rct ion ( level B ) , cardiac tamponade ( level A ) , reoperative bleeding ( level A ) , esophageal injury ( level B ) , low cardiac output ( level A ) , intraaortic balloon ( level B ) , congestive heart failure ( level B ) , ejection fraction ( EF ; level B ) , pleural effusion ( level A ) , pneumonia ( level A ) , renal dysfunction ( level B ) , and mediastinitis ( level A ) . The incidence of esophageal injury remains to be low ( level B ) . 4 . Does not reduce mortality at 1 year ( level A ) . There is a possible reduction in mortality beyond 1 year ( level B ) , but no difference in stroke ( level A ) , myocardial infa rct ion ( level A ) , and heart failure ( level B ) . EF is increased ( + 4.1 % more than control ; level A ) . 5 . Has been shown to improve exercise tolerance at 1 year ( level A ) , but no impact on quality of life at 3 months and 1 year ( level A ) ; however , the methodology used and the number of trials study ing these outcomes are insufficient . 6 . Increases cardiopulmonary bypass and cross-clamp times ( level A ) , with no difference in intensive care unit and hospital length of stay ( level A ) . Overall costs were not reported . Conclusions Given these evidence -based statements , the consensus panel stated that , in patients with persistent and permanent AF undergoing cardiac surgery , concomitant surgical ablation is recommended to increase incidence of sinus rhythm at short- and long-term follow-up ( class 1 , level A ) ; to reduce the risk of stroke and thromboembolic events ( class 2a , level B ) ; to improve EF ( class 2a , level A ) ; and to exercise tolerance ( class 2a , level A ) and long-term survival ( class 2a , level B ) | [
"OBJECTIVE Prospect i ve r and omised study comparing patients with atrial fibrillation ( AF ) of more than 6 months duration after mitral valve surgery plus biatrial modified radiofrequency Maze procedure using Medtronic Cardioblate System ( Cardioblate group , n=24 ) vs mitral valve surgery plus intensive rhythm control strategy ( control group , n=25 ) . METHODS Patients were blinded to r and omisation . Preoperatively , at discharge , and at 3-month and 1-year follow-up , echocardiography , quality of life assessment s and ECGs were done . In both groups , sinus rhythm ( SR ) restoration was attempted by intra- and postoperative DC cardioversion and class III antiarrhythmic medication . All patients received warfarin . Amiodarone and warfarin was considered for discontinuation after 3 months in SR , 24-h Holter or event monitor excluding AF . RESULTS Both groups underwent mitral valve replacement or repair ( Cardioblate vs control : 16:8 vs 10:15 ) , had similar gender ( male : 33 % vs 56 % ) , age ( 66+/-8 years vs 68+/-9 years ) , additional aortic valve replacement ( 7 vs 6 patients ) , tricuspid annuloplasty ( 13 vs 13 patients ) , and CABG ( 10 vs 16 patients ) . There was 0 % operative mortality , 0 % postoperative cerebrovascular accidents , but 2 late deaths in the control group . At discharge , 3- and 12-month follow-up , more patients in the Cardioblate group returned to normal SR compared to control ( 29 % , 57 % and 75 % vs 20 % , 43 % and 39 % ; p=0.030 ) . Return of functional atrial contraction in patients in SR at 1 year was comparable between groups ( 63 % vs 89 % , NS ) , and more likely in non-rheumatic pathology and preoperative AF of shorter duration . The effectiveness of atrial contraction was 36+/-14 % vs 43+/-18 % of transmitral flow and there was no difference between groups . Amiodarone treatment decreased more in Cardioblate group over time ( 92 % , 55 % and 29 % vs 52 % , 52 % and 21 % ; p=0.003 ) , whereas warfarin decrease was comparable ( 100 % , 100 % and 71 % vs 100 % , 95 % and 82 % ; NS ) . CONCLUSIONS Radiofrequency Maze ablation additional to mitral valve surgery result ed in a higher SR conversion rate ( 75 % ) , despite control group treatment with intensive rhythm control strategy having a higher SR conversion rate ( 39 % ) compared to literature ( approximately 25 % ) . Maze ablation result ed in normalisation of atrial function in 63 % of patients converted to SR",
"OBJECTIVES Various modifications have been proposed to the original Cox 's Maze procedure due to concerns about the long bypass and cross clamp times . The efficacy of these procedures has been studied and reported . We conducted a r and omised prospect i ve study to compare three procedures , differing in extent , of ablation in patients in atrial fibrillation who were undergoing surgery for rheumatic valvular heart disease . These procedures utilised radiofrequency in the bipolar mode . The extent of ablation was ( 1 ) biatrial ( replication of the Cox Maze ) ( 2 ) left atrial portion of the Cox Maze and ( 3 ) pulmonary vein isolation along with a control group ( the No Maze group ) . Conversion rate to sinus rhythm was studied over a mid-term follow-up period . METHODS A total of 160 patients were studied with 40 patients in each group . Antiarrhythmic drugs were not used in the three months preceding surgery and for seven days postoperatively . The patients underwent surgery for their valve disease along with the ablative procedure as per r and omisation using radiofrequency microbipolar coagulation and cryoablation . They were followed up and were evaluated for symptomatic improvement , rhythm with ECG documentation and 2D echocardiography . RESULTS Follow-up was available for 133 patients . Mid-term results showed that sinus rhythm was restored in 62.5 % patients of Biatrial Maze group and 57.5 % in the Left Atrial Maze . In the Pulmonary Vein Isolation Maze group , 67.5 % patients converted to NSR whereas in the No Maze group only 20 % patients were in sinus rhythm ( p value for all the groups was 0.001 when compared to the No Maze group ) . The incidence of other arrhythmias was not significant and there were no other major complications . All the patients in sinus rhythm at follow-up were in NYHA functional class I-II and showed good effort tolerance . CONCLUSIONS Results achieved with the three ablative procedures are comparable . Therefore lesser procedures viz . Left Atrial Maze and the Pulmonary Vein Isolation Maze procedures must be studied further with the additional use of antiarrhythmic drugs",
"AIMS The efficacy of epicardial left atrial ( LA ) cryoablation in eliminating atrial fibrillation ( AF ) in patients undergoing mitral valve surgery ( MVS ) is unknown . We hypothesized that MVS combined with LA cryoablation is superior to MVS alone . METHODS AND RESULTS Sixty-nine patients with permanent AF , included at four centres , underwent MVS with or without epicardial LA cryoablation . The primary endpoint was regained sinus rhythm . Risk factors for failed AF cryoablation were eluci date d. Sixty-five out of 69 patients reached the primary endpoint . At 6 and 12 months follow-up , 73.3 % of patients who underwent cryoablation had regained sinus rhythm at both follow-ups , compared with 45.7 and 42.9 % of patients , respectively , who underwent MVS alone ( group differences , at 6 months P = 0.024 , after 12 months P = 0.013 ) . The in-hospital complication rate was 11.4 % in the MVS group and 26.5 % in the cryoablation group ( P = 0.110 ) . Risk factors for failed elimination of AF by cryoablation were duration of permanent AF ( P = 0.012 ) and presence of coronary artery disease ( P = 0.047 ) , according to multiple logistic regression analysis . CONCLUSION This first prospect i ve r and omized study showed that combining MVS with epicardial LA cryoablation is significantly better in eliminating pre-operative permanent AF than MVS alone",
"Background —Although the Cox-Maze III procedure is effective for treating permanent atrial fibrillation ( AF ) , its high complexity limits its use . The Saline-Irrigated Cooled-tip Radiofrequency Ablation ( SICTRA ) System is an alternative source of energy used to ablate AF . The aim of this study was to evaluate the effectiveness of the SICTRA for the treatment of permanent AF in patients with rheumatic mitral valve ( MV ) disease . Methods and Results —Between February 2002 and April 2003 , 70 patients with permanent AF and rheumatic MV disease were r and omly assigned to undergo a modified Maze III procedure using SICTRA associated with MV surgery ( group A ) or MV surgery alone ( group B ) . Groups A and B were similar in terms of baseline characteristics . The in-hospital mortality rate was 2.3 % ( 1 death ) in group A versus 0 % ( no deaths ) in group B ( P>0.99 ) . The additional time required for the left-sided radiofrequency ablation in group A was 14.2±5.1 minutes and for right-sided ablation was 12.3±4.2 minutes . The mean postoperative follow-up periods were 13.8±3.4 and 11.5±7.3 months , respectively , in groups A and B. The overall mid-term survival rate was 95.1 % in group A and 92.8 % in group B ( P>0.99 ) . The cumulative rates of sinus rhythm were 79.4 % in group A and 26.9 % in group B ( P=0.001 ) . Doppler echocardiography documented biatrial transport function in 90.3 % of group A patients in sinus rhythm . Conclusions —The SICTRA is effective for treating permanent AF associated with rheumatic MV disease",
"OBJECTIVE Radiofrequency or the use of microwave energy in combination with atrial size reduction during open heart surgery have been reported to be effective in up to 75 % in the treatment of permanent atrial fibrillation . However , no data from prospect i ve r and omized trials using microwave energy are available . METHODS Forty-three patients with permanent atrial fibrillation undergoing open-heart surgery were r and omly stratified into treatment group receiving microwave ablation and atrial size reduction ( n=24 ) or control group ( n=19 ) . Patients in either group were treated with amiodarone or sotalol for 3 months if sinus rhythm or any atrioventricular rhythm was successfully restored . Follow-up time points were at 3 , 6 and 12 month after surgery . RESULTS In the treatment group 22 out of 24 patients ( 91,7 % ) were successfully converted to sinus rhythm by using intraoperative microwave ablation therapy whereas only six out of 19 ( 31.5 % ) patients converted to sinus rhythm directly after surgery . At 12-month follow-up there were still a significantly higher percentage of patients in the treatment group free from atrial fibrillation when compared to control ( 80 vs. 33.3 % , P=0.036 ) . CONCLUSION The preliminary data from this first prospect ively r and omized trial indicate that microwave ablation combined with atrial size reduction is a safe and highly efficient treatment in permanent atrial fibrillation",
"We analysed 113 reports published in 1980 in a sample of medical journals to relate features of study design to the magnitude of gains attributed to new therapies over old . Overall we rated 87 per cent of new therapies as improvements over st and ard therapies . The mean gain ( measured by the Mann-Whitney statistic ) was relatively constant across study design s , except for non-r and omized controlled trials with sequential assignment to therapy , which showed a significantly higher likelihood that a patient would do better on the innovation than on st and ard therapy ( p = 0.004 ) . R and omized controlled trials that did not use a double-blind design had a higher likelihood of showing a gain for the innovation than did double-blind trials ( p = 0.02 ) . Any evaluation of an innovation may include both bias and the true efficacy of the new therapy , therefore we may consider making adjustments for the average bias associated with a study design . When interpreting an evaluation of a new therapy , readers should consider the impact of the following average adjustments to the Mann-Whitney statistic : for trials with non-r and om sequential assignment a decrease of 0.15 , for non-double-blind r and omized controlled trials a decrease of 0.11",
"AIMS Our aim was to compare the long-term effects on rhythm and quality of life ( QoL ) after left atrial epicardial radiofrequency ( RF ) ablation vs. no ablation in patients undergoing cardiac surgery . METHODS AND RESULTS Thirty-nine patients with ECG documented atrial fibrillation ( AF ) scheduled for coronary artery bypass grafting ( CABG ) with or without concomitant valve surgery were consecutively elected for epicardial RF ablation . Thirty-nine age- and gender-matched patients scheduled for CABG with or without concomitant valve surgery only and with documented AF served as controls . The follow-up after ablation was 32 + /- 11 months . The percentage of patients in sinus rhythm ( SR ) at long-term follow-up was 62 vs. 33 % ( P = 0.03 ) after ablation and no ablation , respectively . SR at 3 months was highly predictive of that at 32 months ( sensitivity 95 % , positive predictive value 86 % ) . Long-term SR was associated with better QoL , fewer symptoms , higher ejection fraction , and smaller left and right atria than AF . CONCLUSION SR at 3 months was highly predictive of long-term SR that was associated with clinical improvement when compared with patients still in AF . AF at 3 months did not preclude a later stabilization to SR",
"CONTEXT Although left atrial radiofrequency ablation ( RFA ) is increasingly used for the treatment of chronic atrial fibrillation during mitral valve surgery , its efficacy to restore sinus rhythm and any result ing benefits have not been examined in the context of an adequately powered r and omized trial . OBJECTIVE To determine whether intraoperative RFA of the left atrium increases the long-term restoration of sinus rhythm and improves exercise capacity . DESIGN , SETTING , AND PATIENTS R and omized , double-blind trial performed in a single UK tertiary referral center with enrollment between December 2001 and November 2003 . A total of 101 patients referred for mitral valve surgery with at least 6 months ' history of uninterrupted atrial fibrillation were assessed for eligibility ; 97 were enrolled . Patients were followed up for 12 months . INTERVENTION Patients were r and omly assigned to undergo mitral valve surgery and RFA of the left atrium ( n = 49 ) or mitral valve surgery alone ( controls ; n = 48 ) . MAIN OUTCOME MEASURES The primary outcome measure was presence of sinus rhythm at 12 months ; secondary measures were patient functional status and exercise capacity ( assessed by shuttle-walk test ) , left atrial contractility , and left atrial and left ventricular dimension and function and plasma levels of B-type natriuretic peptide . RESULTS At 12 months , sinus rhythm was present in 20 ( 44.4 % ) of 45 RFA patients and in 2 ( 4.5 % ) of 44 controls ( rate ratio , 9.8 ; 95 % CI , 2.4 - 86.3 ; P sinus rhythm in the RFA group was accompanied by a greater improvement in mean ( SD ) shuttle-walk distance compared with controls ( + 94 [ 102 ] m vs + 48 [ 82 ] m ; P = .003 ) and a greater reduction in the plasma level of B-type natriuretic peptide ( -104 [ 87 ] fmol/mL vs -51 [ 82 ] fmol/mL ; P = .03 ) . Patients r and omized to receive RFA had similar rates of postoperative complications and deaths as control patients . CONCLUSIONS Radiofrequency ablation of the left atrium during mitral valve surgery for continuous atrial fibrillation significantly increases the rate of sinus rhythm restoration 1 year postoperatively , improving patient exercise capacity . On the basis of its efficacy and safety , routine use of RFA of the left atrium during mitral valve surgery may be justified . TRIAL REGISTRATION Clinical Trials.gov Identifier : NCT00238706",
"AIMS This study is the first prospect i ve r and omized trial evaluating the efficacy of an antiarrhythmic surgical procedure in patients with chronic atrial fibrillation undergoing mitral valve replacement . METHODS AND RESULTS Thirty consecutive patients with chronic atrial fibrillation undergoing mitral valve replacement were r and omized for an additional modified MAZE-operation using intra-operatively cooled-tip radiofrequency ablation ( group A ) or mitral valve replacement alone ( group B ) . Biatrial contraction was studied and functional capacity was evaluated in spiro-ergometry 6 months after surgery . Thirty-day mortality was 0 % in both groups . After 12 months , sinus rhythm was reinstituted significantly more often in patients of group A ( cumulative rate of sinus rhythm 0.800 ) compared to patients in group B ( 0.267 ) ( P Electrocardioversion showed long-term success in only 17 % of patients in group A and 0 % in group B. Maximal aerobic uptake at the 6-month spiro-ergometry revealed no significant difference ( 9.3 vs 8.5 ml x min(-1 ) kg(-1 ) , P=0.530 ) . CONCLUSIONS A modified MAZE operation using cooled-tip radiofrequency ablation can be safely combined with mitral valve surgery and is highly effective in restoring sinus rhythm . Biatrial contraction is found in 66.7 % of patients with sinus rhythm undergoing mitral valve replacement plus the MAZE operation",
"BACKGROUND We evaluated the effectiveness of the saline-irrigated-cooled-tip-radiofrequency ablation ( SICTRA ) to produce linear intraatrial lesions . METHODS Thirty patients with chronic atrial fibrillation and mitral valve disease were consecutively r and omized to have mitral valve operation either with a Maze procedure ( group A ) or without ( group B ) . Intraatrial linear lesions were made with an SICTRA catheter ( 20 to 32 W ; 200 to 320 mL/h saline ) . An echocardiography and 24-hour electrocardiogram were obtained 12 months postoperatively . RESULTS The cumulative frequencies of sinus rhythm in group A and B were 0.80 and 0.27 ( p Restored biatrial contraction was present in 66.7 % ( 6 of 9 ) of the group A patients in sinus rhythm . One patient from each group received a permanent pacemaker because of bradycardia . A fatal renal bleeding and mediastinitis occurred in 2 group A patients , 6 weeks postoperatively . One group A patient had sudden cardiac death at home , 4 months after operation . One patient from each group had lethal respiratory failure , 7 and 10 months after operation . Survival after 12 months for group A and B was 73 % and 93 % ( p = 0.131 ) . CONCLUSIONS The SICTRA appeared to be an effective technique to perform the Maze procedure",
"We analysed the results of 221 comparisons of an innovation with a st and ard treatment in surgery published in six leading surgery journals in 1983 to relate features of study design to the magnitude of gain . For each comparison we measured the gain attributed to the innovation over the st and ard therapy by the Mann-Whitney statistic and the difference in proportion of treatment successes . For primary treatments ( aim ed at curing or ameliorating a patient 's principal disease ) , an average gain of 0.56 was produced by 20 r and omized controlled trials . This was less than the 0.62 average for four non-r and omized controlled trials , 0.63 for 19 externally controlled trials , and 0.57 for 73 record review s ( 0.50 represents a toss-up between innovation and st and ard ) . For secondary therapies ( used to prevent or treat complications of therapy ) , the average gain was 0.53 for 61 r and omized controlled trials , 0.58 for eleven non-r and omized controlled trials , 0.54 for eight externally controlled trials , and 0.55 for 18 record review s. Readers of studies evaluating new treatments , particularly for primary treatments , may consider adjustment of the gain according to the study type",
"OBJECTIVE The aim of this study was to assess the feasibility and effectiveness of irrigated radiofrequency ( RF ) modified Maze procedure through a port access approach during mitral valve surgery and evaluate early and mid-term results . MATERIAL AND METHOD During a 16 months time period , 67 patients with chronic atrial fibrillation ( AF ) eligible for port access mitral valve surgery were r and omly assigned to either Group A , in which they underwent a combined procedure ( N = 33 ) or Group B , in which a valve procedure alone was performed ( N = 34 ) . Both groups were similar in terms of age , sex , valve pathology , duration of AF left atrial diameter and left ventricle function ( P > 0.05 ) . Four had undergone previous operations . RESULTS Median follow-up was 10 months for both groups , 95 % CI ( 9.18 - 10.8 ) . One patient in each group died early postoperatively ( 3 and 2.9 % ) . Two patients required reoperation for bleeding , one in each group ( 3 and 2.9 % ) . There were two conversions to right thoracotomy . In Group A , freedom from AF was 100 % at the end of the operation ( 76 % sinus , 24 % pacemaker ) Six and twelve months freedom from AF was 87.2 and 93.6 % , respectively . In Group B , freedom from AF at the end of operation was 41 % . At the end of 6 and 12 months , freedom from AF was 9.4 % ( P = 0.0001 ) . One patient in Group A required a permanent pacemaker ( 3 % ) . During follow-up , one patient in Group A died of non-cardiac causes ( 3 % ) . In Group B , there were two late deaths : one cardiac ( 2.9 % ) and one neurologic ( 2.9 % ) . There were no thromboembolic events detected in Group A during follow-up , whereas two patients in Group B suffered this complication ( 6 % , P = 0.081 ) . At 12 months , functional capacity had improved for patients in both groups ( P mitral valve surgery and irrigated RF Maze procedure was safe and efficient through a port access approach . There were no procedure related complications like esophageal or coronary artery injury . Early and mid-term results were favourable with 93.6 % of patients free of AF at 1 year in comparison to the 9.4 % of the control group . The data is not sufficient to reach any conclusions in terms of thromboembolic rates , despite favourable results for the RF Maze group . Nevertheless , in terms of feasibilty , sinus rhythm restoration and overall outcome , early results are encouraging and we advocate the use of the combined procedure through a port access approach",
"AIM Mitral valve surgery seldom suppresses atrial fibrillation ( AF ) , present prior to surgery . Maze III surgery eliminates AF in > 80 % of cases , the reason why combining this procedure with mitral valve surgery in patients with AF seems worthwhile . We prospect ively studied the outcome of combining the Maze III procedure with mitral valve surgery . METHODS Thirty-five patients with AF and a mean age of 64 years undergoing mitral valve surgery were prospect ively r and omized according to a 2.5:1 ratio to surgery with ( n=25 ) , or without ( n=10 ) maze III and followed for at least 1 year . RESULTS At discharge and after 12 months freedom from AF was 56 % and 92 % , respectively , in the maze group , and 0 % and 20 % , respectively , in patients without maze ( group differences at discharge p=0.002 , after 12 months p=0.0007 ) . Sinus node incompetence was seen in 1 of 25 maze patients requiring pacing . No in-hospital or late death occurred ; stroke was observed in 1 patient ( without maze ) . Quality of life markedly improved after surgery , but did not differ between patients with or without maze surgery . CONCLUSIONS This first prospect i ve r and omized study shows that combining maze III with mitral valve surgery result ed in a significantly better elimination of preoperative AF than mitral valve surgery alone . As the quality of life did not differ between patients with , or without maze surgery , additional maze surgery is primarily recommended in patients in whom anticoagulation therapy can be avoided after surgery , specifically in patients with scheduled mitral valve plasty",
"INTRODUCTION Intraoperative left atrial radiofrequency ( RF ) ablation recently has been suggested as an effective surgical treatment for atrial fibrillation ( AF ) . The aim of this study was to verify the outcome of this technique in a controlled multicenter trial . METHODS AND RESULTS One hundred three consecutive patients ( 39 men and 65 women ; age 62 + /- 11 years ) affected by AF underwent cardiac surgery and RF ablation in the left atrium ( RF group ) . The control group consisted of 27 patients ( 6 men and 21 women ; age 64 + /- 7 years ) with AF who underwent cardiac surgery during the same period and refused RF ablation . Mitral valve disease was present in 89 ( 86 % ) and 25 ( 92 % ) patients , respectively ( P = NS ) . RF endocardial ablation was performed in order to obtain isolation of both right and left pulmonary veins , a lesion connecting the previous lines , and a lesion connecting the line encircling the left veins to the mitral annulus . Upon discharge from the hospital , sinus rhythm was present in 65 patients ( 63 % ) versus 5 patients ( 18 % ) in the control group ( P Mean time of cardiopulmonary bypass was longer in the RF group ( 148 + /- 50 min vs 117 + /- 30 min , P = 0.013 ) . The complication rate was similar in both groups , but RF ablation-related complications occurred in 4 RF group patients ( 3.9 % ) . After a mean follow-up of 12.5 + /- 5 months ( range 4 - 24 ) , 83 ( 81 % ) of 102 RF group patients were in stable sinus rhythm versus 3 ( 11 % ) of 27 in the control group ( P success rate was similar among the four surgical centers . Atrial contraction was present in 66 ( 79.5 % ) of 83 patients in the RF group in sinus rhythm . CONCLUSION Endocardial RF left atrial compartmentalization during cardiac surgery is effective in restoring sinus rhythm in many patients . This technique is easy to perform and reproducible . Rare RF ablation-related complications can occur . During follow-up , sinus rhythm persistence is good , and biatrial contraction is preserved in most patients",
"BACKGROUND The Cox Maze procedure has been used to treat atrial fibrillation in patients with mitral valve disease . Recently , ectopic foci , originating in the pulmonary veins , were demonstrated in patients with atrial fibrillation , and the indication was that their arrhythmia could have a focal origin . In the light of this new evidence , a simplified surgical technique to isolate the pulmonary veins was developed to eliminate permanent atrial fibrillation in patients undergoing mitral valve surgery . This study compares three surgical procedures proposed to maintain sinus rhythm after mitral valve surgery . METHODS A prospect i ve clinical trial of 30 patients with mitral valve disease and permanent atrial fibrillation who had undergone mitral valve surgery were r and omized in accordance with the type of surgery used on each : ( 1 ) . associated en bloc isolation of pulmonary veins , ( 2 ) . the Maze procedure , or ( 3 ) . mitral valve correction alone . The preoperative clinical characteristics were similar in the three groups . RESULTS The overall postoperative complications were similar in all three groups . The cardiopulmonary bypass time and the aortic cross-clamping time were shorter in the control group , but this factor bore no relation to increased morbidity in the intervention groups . The relative risk of atrial fibrillation after surgery was 0.08 in the group undergoing isolation of pulmonary veins ( p = 0.010 ; 95 % confidence interval , 0.01 to 0.71 ) and 0.20 in the Maze group ( p = 0.044 ; 95 % confidence interval , 0.04 to 1.02 ) compared with the control group . CONCLUSIONS En bloc isolation of pulmonary veins associated with mitral valve surgery appears to be safe and just as effective as the Maze procedure in maintaining sinus rhythm in patients with permanent atrial fibrillation"
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Aims Atrial fibrillation ( AF ) patients have increased risk of stroke . In paroxysmal AF , the combination of duration and frequency of episodes defines AF burden . In patients with cardiac implantable electronic devices ( CIEDs ) , atrial high-rate episodes ( AHREs ) can be monitored continuously and are considered as a proxy for AF . This systematic review aims to determine the relationship between AF burden and risk of thrombo-embolic events ( TBEs ) . Methods and results We search ed Medline , Embase , PubMed , and Cochrane Library data bases and performed a review and meta- analysis . Eligible studies reported rhythm registration with specified AF burden and 3 months of follow-up for TBEs . Of the 8849 identified publications , 7 met the inclusion criteria . Of the 18 943 included patients , 215 ( 1.1 % ) patients developed a TBE . We detected only studies registering AHRE with a duration over 5 min detected by CIED . In a meta- analysis , patients with an AHRE burden over 6 min had an increased risk of TBE when compared with patients without AHRE , but this risk did not increase for an AHRE burden over 6 h [ hazard ratio ( HR ) 1.82 vs. 1.78 ] . In a second meta- analysis , only patients with AHRE burden over 24 h had an increased risk for stroke ( HR 3.2 , 95 % confidence interval 1.75 - 5.86 ) , while patients with an AHRE burden shorter than 24 h did not . Conclusion Patients with an AHRE burden over 6 min have an increased risk for stroke . A trend in which a higher AHRE burden leads to a higher risk for TBEs was observed but not substantiated due to heterogeneity and low numbers | [
"Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items",
"Aim Anticoagulation prophylaxis for stroke is recommended for at-risk patients with either persistent or paroxysmal atrial fibrillation ( AF ) . We compared outcomes in patients with persistent vs. paroxysmal AF receiving oral anticoagulation . Methods and results Patients r and omized in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET-AF ) trial ( n = 14 264 ) were grouped by baseline AF category : paroxysmal or persistent . Multivariable adjustment was performed to compare thrombo-embolic events , bleeding , and death between groups , in high-risk subgroups , and across treatment assignment ( rivaroxaban or warfarin ) . Of 14 062 patients , 11 548 ( 82 % ) had persistent AF and 2514 ( 18 % ) had paroxysmal AF . Patients with persistent AF were marginally older ( 73 vs. 72 , P = 0.03 ) , less likely female ( 39 vs. 45 % , P patients with paroxysmal AF . In patients r and omized to warfarin , time in therapeutic range was similar ( 58 vs. 57 % , P = 0.94 ) . Patients with persistent AF had higher adjusted rates of stroke or systemic embolism ( 2.18 vs. 1.73 events per 100-patient-years , P = 0.048 ) and all-cause mortality ( 4.78 vs. 3.52 , P = 0.006 ) . Rates of major bleeding were similar ( 3.55 vs. 3.31 , P = 0.77 ) . Rates of stroke or systemic embolism in both types of AF did not differ by treatment assignment ( rivaroxaban vs. warfarin , Pinteraction = 0.6 ) . Conclusion In patients with AF at moderate-to-high risk of stroke receiving anticoagulation , those with persistent AF have a higher risk of thrombo-embolic events and worse survival compared with paroxysmal AF",
"Aims Uncertainty exists over the importance of device-detected short- duration atrial arrhythmias . Continuous atrial diagnostics , through home monitoring ( HM ) technology ( BIOTRONIK , Berlin , Germany ) , provides a unique opportunity to assess frequency and quantity of atrial fibrillation ( AF ) episodes defined as atrial high-rate events ( AHRE ) . Methods and results Prospect i ve data from 560 heart failure ( HF ) patients ( age 67 ± 10 years , median ejection fraction 27 % ) patients with a cardiac resynchronization therapy ( CRT ) device capable of HM from two multi-centre studies were analysed . Atrial high-rate events burden was defined as the duration of mode switch in a 24-h period with atrial rates of > 180 beats for at least 1 % or total of 14 min per day . The primary endpoint was incidence of a thromboembolic ( TE ) event . Secondary endpoints were cardiovascular death , hospitalization because of AF , or worsening HF . Over a median 370-day follow-up AHRE occurred in 40 % of patients with 11 ( 2 % ) patients developing TE complications and mortality rate of 4.3 % ( 24 deaths , 16 with cardiovascular aetiology ) . Compared with patients without detected AHRE , patients with detected AHRE>3.8 h over a day were nine times more likely to develop TE complications ( P= 0.006 ) . The majority of patients ( 73 % ) did not show a temporal association with the detected atrial episode and their adverse event , with a mean interval of 46.7 ± 71.9 days ( range 0–194 ) before the TE complication . Conclusion In a high-risk cohort of HF patients , device-detected atrial arrhythmias are associated with an increased incidence of TE events . A cut-off point of 3.8 h over 24 h was associated with significant increase in the event rate . Routine assessment of AHRE should be considered with other data when assessing stroke risk and considering anti-coagulation initiation and should also prompt the optimization of cardioprotective HF therapy in CRT patients",
"OBJECTIVE This study was performed to characterize the risk of stroke in elderly patients with recurrent intermittent atrial fibrillation ( AF ) . BACKGROUND Although intermittent AF is common , relatively little is known about the attendant risk of stroke . METHODS A longitudinal cohort study was performed comparing 460 participants with intermittent AF with 1,552 with sustained AF treated with aspirin in the Stroke Prevention in Atrial Fibrillation studies and followed for a mean of two years . Independent risk factors for ischemic stroke were identified by multivariate analysis . RESULTS Patients with intermittent AF were , on average , younger ( 66 vs. 70 years , p women ( 37 % vs. 26 % p heart failure ( 11 % vs. 21 % , p annualized rate of ischemic stroke was similar for those with intermittent ( 3.2 % ) and sustained AF ( 3.3 % ) . In patients with intermittent AF , independent predictors of ischemic stroke were advancing age ( relative risk [ RR ] = 2.1 per decade , p hypertension ( RR = 3.4 , p = 0.003 ) and prior stroke ( RR = 4.1 , p = 0.01 ) . Of those with intermittent AF predicted to be high risk ( 24 % ) , the observed stroke rate was 7.8 % per year ( 95 % confidence interval 4.5 to 14 ) . CONCLUSIONS In this large cohort of AF patients given aspirin , those with intermittent AF had stroke rates similar to patients with sustained AF and similar stroke risk factors . Many elderly patients with recurrent intermittent AF have substantial rates of stroke and likely benefit from anticoagulation . High-risk patients with intermittent AF can be identified using the same clinical criteria that apply to patients with sustained AF",
"Background —It is unknown if brief episodes of device-detected atrial fibrillation ( AF ) increase thromboembolic event ( TE ) risk . Methods and Results —TRENDS was a prospect i ve , observational study enrolling patients with ≥1 stroke risk factor ( heart failure , hypertension , age ≥65 years , diabetes , or prior TE ) receiving pacemakers or defibrillators that monitor atrial tachycardia (AT)/AF burden ( defined as the longest total AT/AF duration on any given day during the prior 30-day period ) . This time-varying exposure was up date d daily during follow-up and related to TE risk . Annualized TE rates were determined according to AT/AF burden subsets : zero , low ( Patients ( n=2486 ) had at least 30 days of device data for analysis . During a mean follow-up of 1.4 years , annualized TE risk ( including transient ischemic attacks ) was 1.1 % for zero , 1.1 % for low , and 2.4 % for high burden subsets of 30-day windows . Compared with zero burden , adjusted hazard ratios ( 95 % CIs ) in the low and high burden subsets were 0.98 ( 0.34 to 2.82 , P=0.97 ) and 2.20 ( 0.96 to 5.05 , P=0.06 ) , respectively . Conclusions —The TE rate was low compared with patients with traditional AF with similar risk profiles . The data suggest that TE risk is a quantitative function of AT/AF burden . AT/AF burden ≥5.5 hours on any of 30 prior days appeared to double TE risk . Additional studies are needed to more precisely investigate the relationship between stroke risk and AT/AF burden",
"Background —Some current pacing systems can automatically detect and record atrial tachyarrhythmias that may be asymptomatic . We prospect ively studied a 312-patient ( pt ) subgroup of MOST ( MOde Selection Trial ) , a 2010-patient , 6-year r and omized trial of DDDR versus VVIR pacing in sinus node dysfunction ( SND ) . The purpose of the study was to correlate atrial high rate events ( AHREs ) detected by pacemaker diagnostics with clinical outcomes . Methods and Results —Pacemakers were programmed to log an AHRE when the atrial rate was > 220 bpm for 10 consecutive beats . Analysis was confined to patients with at least 1 AHRE duration exceeding 5 minutes . The 312 patients were median age 74 years , 55 % female , and 60 % had a history of SVT . 160 of 312 ( 51.3 % ) patients enrolled had at least 1 AHRE > 5 minutes duration over median follow-up of 27 months . Cox proportional hazards analysis assessed the relationship of AHREs with clinical events , adjusting for prognostic variables and baseline covariates . The presence of any AHRE was an independent predictor of the following : total mortality ( hazard ratio AHRE versus no AHRE and 95 % confidence intervals=2.48 [ 1.25 , 4.91 ] , P = 0.0092 ) ; death or nonfatal stroke ( 2.79 [ 1.51 , 5.15 ] , P = 0.0011 ) ; and atrial fibrillation ( 5.93 [ 2.88 , 12.2 ] , P = 0.0001 ) . There was no significant effect of pacing mode on the presence or absence of AHREs . Conclusions —AHRE detected by pacemakers in patients with SND identify patients that are more than twice as likely to die or have a stroke , and 6 times as likely to develop atrial fibrillation as similar patients without AHRE",
"Aim To investigate whether diagnostic data from implanted cardiac resynchronization therapy defibrillators ( CRT-Ds ) retrieved automatically at 24 h intervals via a Home Monitoring function can enable dynamic prediction of cardiovascular hospitalization and death . Methods and results Three hundred and seventy-seven heart failure patients received CRT-Ds with Home Monitoring option . Data on all deaths and hospitalizations due to cardiovascular reasons and Home Monitoring data were collected prospect ively during 1-year follow-up to develop a predictive algorithm with a predefined specificity of 99.5 % . Seven parameters were included in the algorithm : mean heart rate over 24 h , heart rate at rest , patient activity , frequency of ventricular extrasystoles , atrial – atrial intervals ( heart rate variability ) , right ventricular pacing impedance , and painless shock impedance . The algorithm was developed using a 25-day monitoring window ending 3 days before hospitalization or death . While the retrospective sensitivities of the individual parameters ranged from 23.6 to 50.0 % , the combination of all parameters was 65.4 % sensitive in detecting cardiovascular hospitalizations and deaths with 99.5 % specificity ( corresponding to 1.83 false-positive detections per patient-year of follow-up ) . The estimated relative risk of an event was 7.15-fold higher after a positive predictor finding than after a negative predictor finding . Conclusion We developed an automated algorithm for dynamic prediction of cardiovascular events in patients treated with CRT-D devices capable of daily transmission of their diagnostic data via Home Monitoring . This tool may increase patients ’ quality of life and reduce morbidity , mortality , and health economic burden , it now warrants prospect i ve studies . Clinical Trials.gov NCT00376116",
"Background Oral anticoagulation prevents ischemic strokes in patients with atrial fibrillation ( AF ) . Early detection of AF and subsequent initiation of oral anticoagulation help to prevent strokes in AF patients . Implanted cardiac pacemakers and defibrillators allow seamless detection of atrial high rate episodes ( AHRE ) , but the best antithrombotic therapy in patients with AHRE is not known . Rationale Stroke risk is higher in pacemaker patients with AHRE than in those without , but the available data also show that stroke risk in patients with AHRE is lower than in patients with AF . Furthermore , only a minority of patients with AHRE will develop AF , many strokes occur without a temporal relation to AHRE , and AHRE can reflect other arrhythmias than AF or artifacts . An adequately powered controlled trial of oral anticoagulation in patients with AHRE is needed . Design The Non – vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes ( NOAH – AFNET 6 ) trial tests whether oral anticoagulation with edoxaban is superior to prevent the primary efficacy outcome of stroke or cardiovascular death compared with aspirin or no antithrombotic therapy based on evidence ‐based indications . The primary safety outcome will be major bleeding . NOAH – AFNET 6 will r and omize 3,400 patients with AHRE , but without documented AF , aged ≥65 years with at least 1 other stroke risk factor , to oral anticoagulation therapy ( edoxaban ) or no anticoagulation . All patients will be followed until the end of this investigator‐driven , prospect i ve , parallel‐group , r and omized , event‐driven , double‐blind , multicenter phase IIIb trial . Patients will be censored when they develop AF and offered open‐label anticoagulation . The sponsor is the Atrial Fibrillation NETwork ( AFNET ) . The trial is supported by the DZHK ( German Centre for Cardiovascular Research ) , the BMBF ( German Ministry of Education and Research ) , and Daiichi Sankyo Europe . Conclusion NOAH – AFNET 6 will provide robust information on the effect of oral anticoagulation in patients with atrial high rate episodes detected by implanted devices . Graphical abstract Figure . No Caption available",
"AIMS Atrial tachyarrhythmias ( ATs ) detected by implanted devices are often atrial fibrillation or flutter ( AF ) associated with stroke . We hypothesized that introduction and termination of anticoagulation based upon AT monitoring would reduce both stroke and bleeding . METHODS AND RESULTS We r and omized 2718 patients with dual-chamber and biventricular defibrillators to start and stop anticoagulation based on remote rhythm monitoring vs. usual office-based follow-up with anticoagulation determined by st and ard clinical criteria . The primary analysis compared the composite endpoint of stroke , systemic embolism , and major bleeding with the two strategies . The trial was stopped after 2 years median follow-up based on futility of finding a difference in primary endpoints between groups . A total of 945 patients ( 34.8 % ) developed AT , 264 meeting study anticoagulation criteria . Adjudicated atrial electrograms confirmed AF in 91 % ; median time to initiate anticoagulation was 3 vs. 54 days in the intervention and control groups , respectively ( P Primary events ( 2.4 vs. 2.3 per 100 patient-years ) did not differ between groups ( HR 1.06 ; 95 % CI 0.75 - 1.51 ; P = 0.732 ) . Major bleeding occurred at 1.6 vs. 1.2 per 100 patient-years ( HR 1.39 ; 95 % CI 0.89 - 2.17 ; P = 0.145 ) . In patients with AT , thromboembolism rates were 1.0 vs. 1.6 per 100 patient-years ( relative risk -35.3 % ; 95 % CI -70.8 to 35.3 % ; P = 0.251 ) . Although AT burden was associated with thromboembolism , there was no temporal relationship between AT and stroke . CONCLUSION In patients with implanted defibrillators , the strategy of early initiation and interruption of anticoagulation based on remotely detected AT did not prevent thromboembolism and bleeding . CLINICAL TRIAL REGISTRATION IMPACT Clinical Trials.gov identifier : NCT00559988 ( http:// clinical trials.gov/ct2/show/NCT00559988?term=NCT00559988&rank=1 )",
"Background —Current methods for detecting atrial fibrillation ( AF ) have limited diagnostic yield . Continuous monitoring with automatic arrhythmia detection and classification may improve detection of symptomatic and asymptomatic AF and subsequent patient treatment . The study purpose was to quantify the performance of the first implantable leadless cardiac monitor ( ICM ) with dedicated AF detection capabilities . Methods and Results — Patients ( n=247 ) with an implanted ICM ( Reveal XT , Medtronic Inc , Minneapolis , Minn ) who were likely to present with paroxysmal AF were selected . A special Holter device stored 46 hours of subcutaneously recorded ECG , ICM markers , and 2 surface ECG leads . The ICM automatic arrhythmia classification was compared with the core laboratory classification of the surface ECG . Of the 206 analyzable Holter recordings collected , 76 ( 37 % ) contained at least 1 episode of core laboratory classified AF . The sensitivity , specificity , positive predictive value , and negative predictive value for identifying patients with any AF were 96.1 % , 85.4 % , 79.3 % , and 97.4 % , respectively . The AF burden measured with the ICM was very well correlated with the reference value derived from the Holter ( Pearson coefficient=0.97 ) . The overall accuracy of the ICM for detecting AF was 98.5 % . Conclusions —In this ICM validation study , the dedicated AF detection algorithm reliably detected the presence or absence of AF and the AF burden was accurately quantified . The ICM is a promising new diagnostic and monitoring tool for the clinician to treat AF patients independently of symptoms . Long-term studies are needed to evaluate the clinical benefits of the technology . Clinical Trial Registration — clinical trials.gov Identifier NCT00680927",
"Background Device‐detected sub clinical atrial fibrillation ( AF ) refers to infrequent , short‐lasting , asymptomatic AF that is detected only with long‐term continuous monitoring . Sub clinical AF is common and associated with an increased risk of stroke ; however , the risk of stroke with sub clinical AF is lower than for clinical AF , and very few patients with sub clinical AF alone have been included in large AF anticoagulation trials . The net benefit of anticoagulation in patients with sub clinical AF is unknown . Design ARTESiA is a prospect i ve , multicenter , double‐blind , r and omized controlled trial , recruiting patients with sub clinical AF detected by an implanted pacemaker , defibrillator , or cardiac monitor , and who have additional risk factors for stroke . Patients with clinical AF documented by surface electrocardiogram will be excluded from the study . Participants will be r and omized to receive either apixaban ( according to st and ard AF dosing ) or aspirin 81 mg daily . The primary outcome is the composite of stroke , transient ischemic attack with diffusion‐weighted magnetic resonance imaging evidence of cerebral infa rct ion , and systemic embolism . Approximately 4,000 patients will be enrolled from around 230 clinical sites , with an anticipated mean follow‐up of 36 months until 248 adjudicated primary outcome events have occurred . Summary ARTESiA will determine whether oral anticoagulation therapy with apixaban compared with aspirin reduces the risk of stroke or systemic embolism in patients with sub clinical AF and additional risk factors",
"Atrial fibrillation and atrial flutter are common cardiac arrhythmias associated with an increased risk of stroke in patients with additional risk factors . Anticoagulation ameliorates stroke risk , but because these arrhythmias may occur intermittently without symptoms , initiation of prophylactic therapy is often delayed until electrocardiographic documentation is obtained . The IMPACT study is a multicenter , r and omized trial of remote surveillance technology in patients with implanted dual-chamber cardiac resynchronization therapy defibrillator ( CRT-D ) devices design ed to test the hypothesis that initiation and withdrawal of oral anticoagulant therapy guided by continuous ambulatory monitoring of the atrial electrogram improve clinical outcomes by reducing the combined rate of stroke , systemic embolism , and major bleeding compared with conventional clinical management . For those in the intervention group , early detection of atrial high-rate episodes ( AHRE ) generates an automatic alert to initiate anticoagulation based on patient-specific stroke risk stratification . Subsequently , freedom from AHRE for predefined periods prompts withdrawal of anticoagulation to avoid bleeding . Patients in the control arm are managed conventionally , the anticoagulation decision prompted by incidental detection of atrial fibrillation or atrial flutter during routine clinical follow-up . The results will help define the clinical utility of wireless remote cardiac rhythm surveillance and help establish the critical threshold of AHRE burden warranting anticoagulant therapy in patients at risk of stroke . In this report , we describe the study design and baseline demographic and clinical features of the initial cohort ( 227 patients )",
"Importance In approximately 20 % of atrial fibrillation (AF)–related ischemic strokes , stroke is the first clinical manifestation of AF . Strategies are needed to identify and therapeutically address previously undetected AF . Objective To quantify the incidence of AF in patients at high risk for but without previously known AF using an insertable cardiac monitor . Design , Setting , and Participants This prospect i ve , single-arm , multicenter study was conducted from November 2012 to January 2017 . Visits took place at 57 centers in the United States and Europe . Patients with a CHADS2 score of 3 or greater ( or 2 with at least 1 additional risk factor ) were enrolled . Approximately 90 % had nonspecific symptoms potentially compatible with AF , such as fatigue , dyspnea , and /or palpitations . Exposures Patients underwent monitoring with an insertable cardiac monitor for 18 to 30 months . Main Outcomes and Measures The primary end point was adjudicated AF lasting 6 or more minutes and was assessed at 18 months . Other analyses included detection rates at points from 30 days to 30 months and among CHADS2 score subgroups . Median time from insertion to detection and the percentage of patients subsequently prescribed oral anticoagulation therapy was also determined . Results A total of 446 patients were enrolled ; 233 ( 52.2 % ) were male , and the mean ( SD ) age was 71.5 ( 9.9 ) years . A total of 385 patients ( 86.3 % ) received an insertable cardiac monitor , met the primary analysis cohort definition , and were observed for a mean ( SD ) period of 22.5 ( 7.7 ) months . The detection rate of AF lasting 6 or more minutes at 18 months was 29.3 % . Detection rates at 30 days and 6 , 12 , 24 , and 30 months were 6.2 % , 20.4 % , 27.1 % , 33.6 % , and 40.0 % , respectively . At 18 months , AF incidence was similar among patients with CHADS2 scores of 2 ( 24.7 % ; 95 % CI , 17.3 - 31.4 ) , 3 ( 32.7 % ; 95 % CI , 23.8 - 40.7 ) , and 4 or greater ( 31.7 % ; 95 % CI , 22.0 - 40.3 ) ( P = .23 ) . Median ( interquartile ) time from device insertion to first AF episode detection was 123 ( 41 - 330 ) days . Of patients meeting the primary end point , 13 ( 10.2 % ) had 1 or more episodes lasting 24 hours or longer , and oral anticoagulation therapy was prescribed for 72 patients ( 56.3 % ) . Conclusions and Relevance The incidence of previously undiagnosed AF may be substantial in patients with risk factors for AF and stroke . Atrial fibrillation would have gone undetected in most patients had monitoring been limited to 30 days . Further trials regarding the value of detecting sub clinical AF and of prophylactic therapies are warranted . Trial Registration clinical trials.gov Identifier :"
] | 41162cfc-06ff-11f0-808a-c43d1ab1c353 |
CONTEXT The independent or interactive effects of vitamin D and calcium on adiposity remain inconclusive . OBJECTIVE The objective of this systematic review and meta- analysis was to assess whether vitamin D and calcium supplements cause changes in adiposity . DATA SOURCES MEDLINE , Embase , and the Cochrane Central Register of Controlled Trials data bases were search ed for literature published from 1966 to March 2014 . STUDY SELECTION A systematic search was conducted for r and omized clinical trials with ≥ 50 participants aged ≥ 18 years at baseline who had received at least 12 weeks of treatment . Among the inclusion criteria were supplementation with vitamin D with or without calcium and measurement of adiposity ( weight , body mass index [ BMI ] , and /or fat mass ) . DATA EXTRACTION The primary endpoints assessed were changes in weight , BMI , or fat mass . DATA SYNTHESIS Of 953 trials identified , 26 r and omized clinical trials ( n = 12 , vitamin D alone ; n = 10 , vitamin D plus calcium versus calcium control ; n = 4 , vitamin D plus calcium versus placebo ) with a total of 42,430 participants ( median duration , 12 months ) met the inclusion criteria . When compared with placebo , vitamin D supplementation had no significant effect on BMI ( weighted mean difference [ WMD ] , -0.06 kg/m(2 ) ; 95 % confidence interval [ 95%CI ] , -0.14 to 0.03 ) , weight ( WMD , -0.05 kg ; 95%CI , -0.32 to 0.23 ) , or fat mass ( WMD , -0.43 kg ; 95%CI , -1.69 to 0.84 ) . Likewise , no significant reduction in BMI ( WMD , 0.02 kg/m(2 ) ; 95%CI , -0.11 to 0.14 ) , weight ( WMD , 0.12 kg ; 95%CI , -0.24 to 0.49 ) , or fat mass ( WMD , 0.12 kg ; 95%CI , -0.22 to 0.45 ) was observed in participants who received vitamin D plus calcium compared with those who received calcium control . CONCLUSIONS Supplementation with vitamin D showed no effect on adiposity measures in adults | [
"Vitamin D insufficiency and low calcium intake contribute to increase parathyroid function and bone fragility in elderly people . Calcium and vitamin D supplements can reverse secondary hyperparathyroidism thus preventing hip fractures , as proved by Decalyos I. Decalyos II is a 2-year , multicenter , r and omized , double-masked , placebo-controlled confirmatory study . The intention-to-treat population consisted of 583 ambulatory institutionalized women ( mean age 85.2 years , SD = 7.1 ) r and omized to the calcium – vitamin D3 fixed combination group ( n= 199 ) ; the calcium plus vitamin D3 separate combination group ( n= 190 ) and the placebo group ( n= 194 ) . Fixed and separate combination groups received the same daily amount of calcium ( 1200 mg ) and vitamin D3 ( 800 IU ) , which had similar pharmacodynamic effects . Both types of calcium-vitamin D3 regimens increased serum 25-hydroxyvitamin D and decreased serum intact parathyroid hormone to a similar extent , with levels returning within the normal range after 6 months . In a subgroup of 114 patients , femoral neck bone mineral density ( BMD ) decreased in the placebo group ( mean = –2.36 % per year , SD = 4.92 ) , while remaining unchanged in women treated with calcium-vitamin D3 ( mean = 0.29 % per year , SD = 8.63 ) . The difference between the two groups was 2.65 % ( 95 % CI = –0.44 , 5.75 % ) with a trend in favor of the active treatment group . No significant difference between groups was found for changes in distal radius BMD and quantitative ultrasonic parameters at the os calcis . The relative risk ( RR ) of HF in the placebo group compared with the active treatment group was 1.69 ( 95 % CI = 0.96 , 3.0 ) , which is similar to that found in Decalyos I ( RR = 1.7 ; 95 % CI = 1.0 , 2.8 ) . Thus , these data are in agreement with those of Decalyos I and indicate that calcium and vitamin D3 in combination reverse senile secondary hyperparathyroidism and reduce both hip bone loss and the risk of hip fracture in elderly institutionalized women",
"OBJECTIVE Low vitamin D levels predict the development of diabetes . This double-blind , r and omized , control study in subjects with prediabetes and hypovitaminosis D evaluated whether high doses of vitamin D for 1 year affected insulin secretion , insulin sensitivity , and the development of diabetes . RESEARCH DESIGN AND METHODS A total of 1,551 subjects ≥40 years of age not known to have diabetes were screened with A1C levels . Subjects with A1C levels of 5.8–6.9 % underwent an oral glucose tolerance test ( OGTT ) . Subjects with prediabetes and 25-OH vitamin D ( 25-OHD ) levels were r and omized to receive weekly placebo ( n = 53 ) or vitamin D ( n = 56 ) with doses based on body weight and baseline 25-OHD levels . OGTTs were performed 3 , 6 , 9 , and 12 months later . Insulin secretion and sensitivity were measured , and the proportion of subjects developing diabetes was assessed . RESULTS 25-OHD levels rapidly rose from 22 to nearly 70 ng/mL after vitamin D supplementation with a mean weekly dose of 88,865 IU . There were no differences between the placebo and vitamin D groups regarding fasting plasma glucose , 2-h glucose , or insulin secretion and sensitivity or in the percent developing diabetes or returning to normal glucose tolerance . No subjects experienced increased serum or urinary calcium levels . At 12 months , A1C levels were significantly slightly less ( 0.2 % ) in the vitamin D group . CONCLUSIONS In individuals with prediabetes and hypovitaminosis D , doses of vitamin D supplementation design ed to raise serum 25-OHD levels into the upper-normal range for 1 year had no effect on insulin secretion , insulin sensitivity , or the development of diabetes compared with placebo administration",
"Background It is undetermined whether calcium supplementation has an effect on obesity or body composition in postmenopausal women . The purpose of the study is to detect the effect of calcium supplementation on indices of obesity and body composition . Methods This is a secondary analysis of data from a population -based , double-blind , placebo-controlled , r and omized trial design ed to determine the effects of calcium and vitamin D on osteoporotic fractures . The cohort included 1179 postmenopausal women who were r and omly assigned into one of three groups : 1 ) supplemental calcium ( 1400 mg/d or 1500 mg/d ) plus vitamin D placebo ( Ca-only group ) ; 2 ) supplemental calcium ( 1400 mg/d or 1500 mg/d ) plus supplemental vitamin D3 ( 1100 IU/d ) ( Ca + D group ) ; or , 3 ) two placebos ( placebo group ) . After applying the exclusion criteria for this analysis , 870 subjects were included in this study . The primary outcomes for the present study were changes in body mass index , trunk fat , trunk lean , and percentage of trunk fat after calcium supplementation . Results Changes in trunk fat , trunk lean , and percentage of trunk fat were significantly different between the calcium intervention groups ( Ca-only group or Ca + D group ) and the placebo group during the trial ( P calcium intervention groups gained less trunk fat and maintained more trunk lean when compared to the placebo group . No significant difference was observed for body mass index between groups . Conclusion Calcium supplementation over four years has a beneficial effect on body composition in postmenopausal women",
"BACKGROUND Adequate calcium intake can have a favorable effect on some metabolic variables . OBJECTIVE The objective of the study was to determine the effects of daily calcium intake and of supplementation with calcium and vitamin D ( calcium+D ) during a weight-loss intervention on blood pressures , plasma lipid and lipoprotein concentrations , and glucose and insulin concentrations in low calcium consumers . DESIGN Healthy , overweight or obese women ( n = 63 ) with a daily calcium intake of were r and omly assigned in a double-blind manner to 1 of 2 groups : the group consuming 2 tablets/d of a calcium + vitamin D supplement ( 600 mg elemental calcium and 200 IU vitamin D/tablet ) or the group consuming placebo ; both groups observed a 700 kcal/d energy restriction . These 63 women then completed a 15-wk weight-loss intervention . RESULTS Initial daily calcium intake was significantly correlated with plasma HDL cholesterol ( r = 0.41 , P 2-h postload glycemia ( r = -0.29 , P total : LDL and LDL : HDL ( P LDL cholesterol ( P calcium+D group than in the placebo group . The differences in total : HDL and LDL : HDL were independent of changes in fat mass and in waist circumference . A tendency for more beneficial changes in HDL cholesterol , triacylglycerol , and total cholesterol was also observed in the calcium+D group ( P = 0.08 ) . CONCLUSION Consumption of calcium+D during a weight-loss intervention enhanced the beneficial effect of body weight loss on the lipid and lipoprotein profile in overweight or obese women with usual low daily calcium intake",
"BACKGROUND Changes in body composition in men and women occur with age , but these changes are affected by numerous covariate factors . OBJECTIVE The study examined patterns of change in body composition and determined the effects of long-term patterns of change in physical activity in older men and women and in menopausal status and estrogen use in women . DESIGN Serial measures of height , weight , body mass index ( BMI ) , total body fat ( BF ) , percentage BF , and fat-free mass ( FFM ) from underwater weighing of 102 men and 108 women enrolled in the Fels Longitudinal Study were analyzed . Physical activity levels and menopausal status were included as covariates . RESULTS There were significant age-related decreases in FFM and height and increases in total BF , percentage BF , weight , and BMI . Physical activity was associated with decreases in total BF , percentage BF , weight , and BMI in men and were associated with increases in FFM and decreases in total BF and percentage BF in women . Postmenopausal women had significantly higher total BF and percentage BF than did pre- and perimenopausal women . The longer the time since menopause the greater were the increases in weight , BMI , total BF , and percentage BF ; however , estrogen use attenuated these increases . CONCLUSIONS Low FFM can be improved by increased physical activity . The effects of an intervention program on body composition can be masked if only body weight or BMI is measured . The effects of physical activity were more profound in postmenopausal than in premenopausal women , and estrogen use had beneficial effects on body composition",
"BACKGROUND Ergocalciferol ( vitamin D(2 ) ) supplementation plays a role in fall prevention , but the effect in patients living in the community in sunny climates remains uncertain . We evaluated the effect of ergocalciferol and calcium citrate supplementation compared with calcium alone on the risk of falls in older women at high risk of falling . METHODS A 1-year population -based , double-blind , r and omized controlled trial of 302 community-dwelling ambulant older women aged 70 to 90 years living in Perth , Australia ( latitude , 32 degrees S ) , with a serum 25-hydroxyvitamin D concentration of less than 24.0 ng/mL and a history of falling in the previous year . Participants were r and omized to receive ergocalciferol , 1000 IU/d , or identical placebo ( hereinafter , ergocalciferol and control groups , respectively ) . Both groups received calcium citrate , 1000 mg/d . Fall data were collected every 6 weeks . RESULTS Ergocalciferol therapy reduced the risk of having at least 1 fall over 1 year after adjustment for baseline height , which was significantly different between the 2 groups ( ergocalciferol group , 53.0 % ; control group , 62.9 % ; odds ratio [ OR ] , 0.61 ; 95 % confidence interval [ CI ] , 0.37 - 0.99 ) . When those who fell were grouped by the season of first fall or the number of falls they had , ergocalciferol treatment reduced the risk of having the first fall in winter and spring ( ergocalciferol group , 25.2 % ; control group , 35.8 % ; OR , 0.55 ; 95 % CI , 0.32 - 0.96 ) but not in summer and autumn , and reduced the risk of having 1 fall ( ergocalciferol group , 21.2 % ; control group , 33.8 % ; OR , 0.50 ; 95 % CI , 0.28 - 0.88 ) but not multiple falls . CONCLUSION Patients with a history of falling and vitamin D insufficiency living in sunny climates benefit from ergocalciferol supplementation in addition to calcium , which is associated with a 19 % reduction in the relative risk of falling , mostly in winter",
"OBJECTIVE A possible role for vitamin D deficiency in contributing to the winter increase in cardiovascular disease mortality was investigated by testing the effect of vitamin D supplementation on blood pressure and other cardiovascular risk factors during winter . DESIGN R and omised double-blind trial of vitamin D supplementation in winter . SUBJECTS Men and women , mean age 70 years ( range 63 - 76 ) recruited from general practitioner age-sex registers in Cambridge ( UK ) . INTERVENTION 95 people received a single oral dose of 2.5 mg cholecalciferol and 94 received the placebo at baseline interviews during December 1991 . Follow-up assessment was 5 weeks later during January 1992 . RESULTS Comparing follow-up with baseline assessment , serum 25-hydroxyvitamin D increased in the treated group and decreased slightly in the placebo group [ mean ( s.d . ) change : 7.2 ( + /- 3.8 ) vs -1.4 ( + /- 1.1 ) ng/ml , P = 0.0001 ] ; while parathyroid hormone decreased in the treated , and increased in the placebo , group [ -0.27 ( + /- 0.78 ) vs 0.13 ( + /- 0.75 ) pmol/l , P = 0.0004 ] . However , the mean change in blood pressure was similar in both groups : systolic -5 ( + /- 13 ) vs -5 ( + /- 16 ) mmHg , P = 0.81 ; diastolic -1 ( + /- 9 ) vs -1 ( + /- 9 ) , P = 0.92 ; as was the mean change in serum cholesterol [ -0.07 ( + /- 0.52 ) vs -0.05 ( + /- 0.60 ) mmol/l , P = 0.81 ] . In contrast , the mean change in radial pulse was significantly decreased in the treated group compared with placebo [ -2 ( + /- 9 ) vs 1 ( + /- 7 ) beats per min , P = 0.030 ] . CONCLUSIONS The failure of vitamin D supplementation to change blood pressure or serum cholesterol suggests that the winter increase in these factors is not caused by decreased vitamin D levels",
"OBJECTIVE Investigate whether cholecalciferol supplementation leads to weight loss in overweight and obese adults . DESIGN R and omized double blind clinical trial with 20,000 IU cholecalciferol twice a week , or 20,000 IU once a week plus placebo , or placebo twice a week , for 12 months . All subjects were given 500 mg calcium supplementation . METHODS Four hundred and forty five healthy , overweight , and obese men and women ( age 21 - 70 years , body mass index ( BMI ) 28.0 - 47.0 kg/m(2 ) ) . Body weight , fatness , and fat distribution parameters were measured by dual-energy X-ray absorptiometry and anthropometry , blood sample s and 24-h urinary sample s were collected . RESULTS At baseline , there were no significant differences between the groups , but there was a significant inverse relation between serum 25-hydroxyvitamin D ( 25(OH)D ) levels and BMI , and a significant positive association between calorie intake and BMI . Three hundred and thirty four subjects completed the study . During the study , there was no significant change in weight , waist-to-hip ratio ( WHR ) or percentage body fat in any of the groups , nor between them . Parathyroid hormone decreased and 25(OH)D increased significantly in both groups receiving cholecalciferol , and serum levels of 25(OH)D stabilized after 3 months . Serum calcium was unchanged in all groups . Urinary calcium excretion increased in all groups , but there was no significant difference between the groups . Weekly dosage of 20,000 - 40,000 IU cholecalciferol for 12 months was associated with a low risk of adverse effects , at least in overweight and obese adults living at latitude 70 degrees N. CONCLUSION Significant weight reduction in overweight and obese subjects is unlikely to occur with cholecalciferol supplementation",
"This r and omized , double-blind , placebo-controlled study was conducted to compare the effect of a 15-week weight-reducing programme ( -2900 kJ/d ) coupled with a calcium plus vitamin D ( calcium+D ) supplementation ( 600 mg elemental calcium and 5 microg vitamin D , consumed twice a day ) or with a placebo , on body fat and on spontaneous energy/macronutrient intake . Sixty-three overweight or obese women ( mean age 43 years , mean BMI 32 kg/m2 ) reporting a daily calcium intake . Anthropometric variables , resting energy expenditure and spontaneous energy intake were measured before and after the 15-week programme . The calcium+D supplementation induced no statistically significant increase in fat mass loss in response to the programme . However , when analyses were limited to very low-calcium consumers only ( initial calcium intake calcium+D , n 6 for placebo ) , a significant decrease in body weight and fat mass ( P spontaneous dietary lipid intake ( P calcium+D but not in the placebo group . In very low-calcium consumers , change in fat mass was positively correlated with change in lipid intake . During the weight-reducing programme , a calcium+D supplementation was necessary in female overweight/obese very low-calcium consumers to reach significant fat mass loss that seemed to be partly explained by a decrease in lipid intake . We propose that this change in lipid intake could be influenced by a calcium-specific appetite control",
"Background Vitamin D concentrations are linked to body composition indices , particularly body fat mass . Relationships between hypovitaminosis D and obesity , described by both BMI and waist circumference , have been mentioned . We have investigated the effect of a 12-week vitamin D3 supplementation on anthropometric indices in healthy overweight and obese women . Methods In a double-blind , r and omized , placebo-controlled , parallel-group trial , seventy-seven participants ( age 38±8.1 years , BMI 29.8±4.1 kg/m2 ) were r and omly allocated into two groups : vitamin D ( 25 μg per day as cholecalciferol ) and placebo ( 25 μg per day as lactose ) for 12 weeks . Body weight , height , waist , hip , fat mass , 25(OH ) D , iPTH , and dietary intakes were measured before and after the intervention . Results Serum 25(OH)D significantly increased in the vitamin D group compared to the placebo group ( 38.2±32.7 nmol/L vs. 4.6±14.8 nmol/L ; P ) and serum iPTH concentrations were decreased by vitamin D3 supplementation ( -0.26±0.57 pmol/L vs. 0.27±0.56 pmol/L ; P decrease in body fat mass in the vitamin D group compared to the placebo group ( -2.7±2.1 kg vs. -0.47±2.1 kg ; P However , body weight and waist circumference did not change significantly in both groups . A significant reverse correlation between changes in serum 25(OH ) D concentrations and body fat mass was observed ( r = -0.319 , P = 0.005 ) . Conclusion Among healthy overweight and obese women , increasing 25(OH ) D concentrations by vitamin D3 supplementation led to body fat mass reduction . This trial is registered at clinical trials.gov as NCT01344161",
"There is increasing epidemiological evidence linking sub-optimal vitamin D status with overweight and obesity . Although increasing BMI and adiposity have also been negatively associated with the change in vitamin D status following supplementation , results have been equivocal . The aim of this r and omised , placebo-controlled study was to investigate the associations between anthropometric measures of adiposity and the wintertime serum 25-hydroxycholecalciferol ( 25(OH)D ) response to 15 μg cholecalciferol per d in healthy young and older Irish adults . A total of 110 young adults ( 20 - 40 years ) and 102 older adults ( ≥ 64 years ) completed the 22-week intervention with > 85 % compliance . The change in 25(OH)D from baseline was calculated . Anthropometric measures of adiposity taken at baseline included height , weight and waist circumference ( WC ) , along with skinfold thickness measurements to estimate fat mass ( FM ) . FM was subsequently expressed as FM ( kg ) , FM ( % ) , FM index ( FMI ( FM kg/height m2 ) ) and as a percentage ratio to fat-free mass ( FFM ) . In older adults , vitamin D status was inversely associated with BMI ( kg/m2 ) , WC ( cm ) , FM ( kg and % ) , FMI ( kg/m2 ) and FM : FFM ( % ) at baseline ( r - 0·33 , - 0·36 , - 0·33 , - 0·30 , - 0·33 and - 0·27 , respectively , all P values BMI in older adults was also negatively associated with the change in 25(OH)D following supplementation ( β - 1·27 , CI - 2·37 , - 0·16 , P = 0·026 ) ; however , no such associations were apparent in younger adults . Results suggest that adiposity may need to be taken into account when determining an adequate wintertime dietary vitamin D intake for healthy older adults residing at higher latitudes",
"OBJECTIVE The positive short-term effects of postmenopausal hormone replacement therapy ( HRT ) on serum lipids are well known , but it has been suggested that they vanish with time . Cholecalciferol ( vitamin D3 ) is widely used to prevent postmenopausal osteoporosis but the influence of vitamin D3 on serum lipids is poorly known . The long-term effects of HRT and vitamin D3 on the concentrations of serum lipids were studied in a population -based prospect i ve 3-year study . DESIGN AND METHODS 464 women were r and omized into four treatment groups : ( i ) HRT ( sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate ) , ( ii ) Vit D3 ( vitamin D3 300 IU/day ) , ( iii ) HRT+Vit D3 ( both as above ) , ( iv ) placebo ( calcium lactate 500 mg/day ) . RESULTS 320 women completed the study . After three years of treatment , serum concentrations of low density lipoprotein ( LDL ) cholesterol decreased in the HRT group ( 10.1 % , P HRT+Vit D3 group ( 5.9 % , P=0.005 ) , increased in the Vit D3 group ( 4.1 % , P=0.035 ) but remained unchanged in the placebo group . The concentrations of total cholesterol decreased by 5.8 % in the HRT group ( P HRT+Vit D3 group ( P=0.023 ) , but did not change in the other two groups . Serum concentrations of high density lipoprotein ( HDL ) cholesterol decreased in the Vit D3 group ( 5.2 % , P=0.001 ) , HRT+Vit D3 group ( 3.7 % , P=0.046 ) , and the placebo group ( 4.5 % , P=0.006 ) but did not change significantly in the HRT group . The HDL/LDL ratio increased in the HRT group ( 10.5 % , P=0.006 ) and decreased in the Vit D3 group ( 10.5 % , P serum triglycerides increased similarly in all groups ( 14.0 - 18.8 % , P HRT with sequential estradiol valerate and cyproterone acetate on serum lipid concentrations . In addition , the results suggest that vitamin D3 supplementation may have unfavorable effects on lipids in postmenopausal women . Pure vitamin D3 treatment was associated with increased serum LDL cholesterol . Furthermore , the beneficial effects of HRT on serum LDL cholesterol content were reduced when estradiol valerate was combined with vitamin D3 . However , the relevance of these associations to cardiovascular morbidity remains to be established",
"OBJECTIVE Vitamin D deficiency is associated with an unfavorable metabolic profile in observational studies . The intention was to compare insulin sensitivity ( the primary end point ) and secretion and lipids in subjects with low and high serum 25(OH)D ( 25-hydroxyvitamin D ) levels and to assess the effect of vitamin D supplementation on the same outcomes among the participants with low serum 25(OH)D levels . RESEARCH DESIGN AND METHODS Participants were recruited from a population -based study ( the Tromsø Study ) based on their serum 25(OH)D measurements . A 3-h hyperglycemic clamp was performed , and the participants with low serum 25(OH)D levels were thereafter r and omized to receive capsules of 20,000 IU vitamin D3 or identical-looking placebo twice weekly for 6 months . A final hyperglycemic clamp was then performed . RESULTS The 52 participants with high serum 25(OH)D levels ( 85.6 ± 13.5 nmol/L [ mean ± SD ] ) had significantly higher insulin sensitivity index ( ISI ) and lower HbA1c and triglycerides ( TGs ) than the 108 participants with low serum 25(OH)D ( 40.3 ± 12.8 nmol/L ) , but the differences in ISI and TGs were not significant after adjustments . After supplementation , serum 25(OH)D was 142.7 ± 25.7 and 42.9 ± 17.3 nmol/L in 49 of 51 completing participants r and omized to vitamin D and 45 of 53 r and omized to placebo , respectively . At the end of the study , there were no statistically significant differences in the outcome variables between the two groups . CONCLUSIONS Vitamin D supplementation to apparently healthy subjects with insufficient serum 25(OH)D levels does not improve insulin sensitivity or secretion or serum lipid profile ",
"Vitamin D functions are not limited to skeletal health benefits and may extend to preservation of insulin secretion and insulin sensitivity . This review summarizes the literature related to potential vitamin D influences on glucose homeostasis and insulin sensitivity . Cross-sectional data provide some evidence that circulating 25-hydroxyvitamin D ( 25(OH)D ) is inversely associated with insulin resistance , although direct measurements of insulin sensitivity are required for confirmation . Reported associations with insulin secretion , however , are contradictory . Available prospect i ve studies support a protective influence of high 25(OH)D concentrations on type 2 diabetes mellitus risk . There is a general lack of consistency in vitamin D intervention outcomes on insulin secretion and sensitivity , likely due to differences in subject population s , length of interventions , and forms of vitamin D supplementation . Vitamin D receptor gene polymorphisms and vitamin D interactions with the insulin like growth factor system may further influence glucose homeostasis . The ambiguity of optimal vitamin D dosing regimens and optimal therapeutic concentrations of serum 25(OH)D limit available intervention studies . Future studies , including cross-sectional and prospect i ve , should be performed in population s at high risk for both vitamin D deficiency and type 2 diabetes mellitus . Well- design ed , placebo-controlled , r and omized intervention studies are required to establish a true protective influence of vitamin D on glucose homeostasis",
"OBJECTIVE To determine the associations between body adiposity and change in serum 25-(OH)D levels over 2.6 years , and if these associations are mediated by metabolic and inflammatory factors in older adults . METHODS This is a longitudinal study of 859 r and omly selected subjects ( mean 62 years , range 51 - 80 , 49 % women ) . Serum 25-hydroxyvitamin D [ 25-(OH)D ] was assessed by radioimmunoassay at baseline and 2.6 years later . Baseline serum level of leptin was assessed by radioimmunoassay and interleukin (IL)-6 by a chemiluminescent immunoassay in the first 183 subjects . RESULTS In multivariable analyses , body mass index , trunk fat percentage and waist-to-hip ratio were significant predictors of increased incident vitamin D deficiency [ a 25-(OH)D . Change in 25-(OH)D levels per annum was also independently predicted by baseline leptin ( β : -0.09/unit , 95 % CI : -0.17 , -0.03 ) , IL-6 ( β : -0.68/quartile , 95 % CI : -1.35 , -0.02 ) and total cholesterol/high-density lipoprotein ( HDL ) ratio ( β : -0.51 , 95 % CI : -0.88 , -0.14 ) . The associations between body adiposity measures and change in 25-(OH)D completely disappeared after adjustment for leptin , diminished after adjustment for IL-6 , but remained unchanged after adjustment for total cholesterol/HDL ratio . All associations were independent of season and sun exposure . CONCLUSIONS Body fat is not simply a passive reservoir for 25-(OH)D. In addition to season and sun exposure , 25-(OH)D levels appear to be determined by metabolic and , to a lesser extent , inflammatory factors , and these appear to mediate the effects of adiposity on change in",
"Background : Dairy products not only reduce the risk of hypertension and cardiovascular diseases but may play a role in the treatment of obesity . As there is some evidence that calcium ( Ca ) and vitamin D may play a role in effective weight management , we decided to evaluate the influence of Ca and vitamin D supplementation on weight and fat loss in obese women . Material and Methods : Forty obese women were enrolled in this study . Subjects were divided into 2 groups comparable with body mass index ( BMI ) and age . Group 1 was provided with calcium carbonate and 1-(OH)-vitamin D supplementation . Group 2 was provided with only a diet . Subjects participated in a 3-month weight reduction therapy ( balanced diet , modification of life style , and regular physical exercise ) . Blood sample s ( serum concentration of Ca , phosphorus ( P ) , parathormone ( PTH ) , 25-(OH)-D3 ) and clinical characteristics ( weight , height , BMI , body composition ) were taken at baseline and after the 3-month program . Results : No significant differences of body weight , body fat content , serum parathormone , 25-(OH)-D3 concentration , and plasma total Ca and P concentration were observed between analyzed groups both before and after the treatment . Additionally , we did not observe any significant influence of Ca and vitamin D supplementation on weight and fat loss . Conclusion : Ca plus vitamin D supplementation during a 3-month low caloric diet has no additional effect on weight and fat loss in obese women",
"OBJECTIVES To determine whether relative vitamin D deficiency during the winter months contributes to age-related bone loss and whether rates of change in hard- and soft-tissue mass vary during the year . DESIGN Double-blind , placebo-controlled , 1-year trial in 249 women in which equal numbers of women were r and omized to either placebo or 400 IU of vitamin D daily . All women received 377 mg/d of supplemental calcium largely as calcium citrate malate . PATIENTS Healthy , ambulatory postmenopausal women with usual intakes of vitamin D of 100 IU/d . MEASUREMENTS Duplicate spine and whole-body scans were done by dual energy x-ray absorptiometry at 6-month intervals that were timed to periods when 25-hydroxyvitamin D levels were highest and lowest . Period 1 was June-July to December-January and period 2 was December-January to the next June-July . Serum parathyroid hormone and plasma 25-hydroxyvitamin D levels were measured during periods 1 and 2 . MAIN RESULTS In the placebo group , spinal bone mineral density increased in period 1 , decreased in period 2 , and sustained no net change . Women treated with vitamin D had a similar spinal increase in period 1 ( 1.46 % compared with 1.40 % in placebo ) , less loss in period 2 ( -0.54 % compared with -1.22 % , CI for the difference , 0.05 % to 1.31 % , P = 0.032 ) and a significant overall benefit ( 0.85 % compared with 0.15 % , CI for the difference , 0.03 % to 1.37 % , P = 0.04 ) . In period 2 , 25-hydroxyvitamin D levels were lower and parathyroid hormone levels were higher in the placebo than in the vitamin D group . Whole-body lean and fat tissue and bone mineral density varied during the year but did not change overall . CONCLUSIONS At latitude 42 degrees , healthy postmenopausal women with vitamin D intakes of 100 IU daily can significantly reduce late wintertime bone loss and improve net bone density of the spine over one year by increasing their intake of vitamin D to 500 IU daily . A long-term benefit of preventing vitamin D insufficiency in the winter seems likely although it remains to be shown . Observed changes in bone as well as in fat and lean tissue appear to be related to season",
"Peripheral quantitative computed tomography ( pQCT ) imaging has been used to quantify muscle area and density as well as intermuscular adipose tissue ( IMAT ) and subcutaneous adipose tissue ( SAT ) area in the lower and upper limb . Numerous protocol s have been reported to derive these soft-tissue outcomes , but their precision has not been assessed in community-dwelling postmenopausal women . The objective of this study was to compare the precision of previously reported analysis protocol s for quantifying muscle area and density , as well as IMAT and SAT area in postmenopausal women . Six image analysis protocol s using two available software suites ( Stratec XCT , BoneJ ) were identified from the pQCT literature . Analysis protocol s were applied to a sample of 35 older female adults ( mean age 73.7 ; SD 7.2 years ) , r and omly selected from a population based-cohort and scanned twice within an average of 9.7 ( SD 3.6 ) days . Relative precision was calculated as absolute values and as a percentage of the sample mean ( root mean square coefficient of variation ; CV%RMS ) . Soft-tissue outcomes across protocol s were compared on their log-transformed coefficients of variation using multilevel linear models and Tukey contrasts . For most protocol s , CV%RMS for muscle area , density , and SAT area ranged between 2.1 and 3.7 % , 0.7 and 1.9 % , and 2.4 and 6.4 % , respectively . Precision for IMAT area varied considerably , from 3 to 42 % . Consideration of these study results will aid in the selection of appropriate image analysis protocol s for pQCT-derived soft-tissue outcomes in postmenopausal women",
"The aim of the current study was to examine whether calcium supplementation could prevent bone loss in postmenopausal women or more favourable outcomes could be obtained via the consumption of dairy products fortified with calcium and vitamin D3 . For this purpose changes in bone mineral density ( BMD ) at different skeletal sites , assessed by dual-energy X-ray absorptiometry , as well as in quantitative ultrasound ( QUS ) parameters of the calcaneus over 12 months were estimated . A population of 101 postmenopausal women ( 55 - 65 years old ) was r and omized into a dairy group ( DG : n 39 ) , receiving approximately 1200 mg calcium/d and 7.5 microg vitamin D3/d through fortified dairy products ; a calcium-supplemented group ( CaG : n 26 ) provided with a calcium supplement of 600 mg/d ; and a control group ( CG : n 36 ) . Over the intervention period the DG was found to have more favourable changes in pelvis ( P=0.040 ) , total spine ( P total body BMD ( P lumbar spine BMD ( 2.0 % ; 95 % CI 0.5 , 3.5 ) although it did not differentiate significantly compared to the other groups . No significant differences were observed with respect to the changes in QUS parameters . The current study revealed that recommended intakes of vitamin D3 and calcium via fortified dairy products for 12 months can induce favourable changes in pelvis , total spine and total body BMD in postmenopausal women but not in QUS parameters . No such favourable changes were observed via supplementation of calcium alone",
"Background Studies have suggested that vitamin D may be important for both insulin sensitivity and insulin secretion , and that supplementation with vitamin D may subsequently prevent development of type 2 diabetes . Aim of the study The objective of the current study was to test the hypothesis that supplementation with vitamin D would improve glycaemic control in subjects with type 2 diabetes . Methods Thirty-six subjects with type 2 diabetes , treated with metformin and bed-time insulin , were r and omised to supplementation with cholecalciferol ( 40,000 IU per week ) versus placebo for 6 months . Thirty-two subjects participated throughout the entirety of the study . Fasting blood sample s were drawn before and at the end of the 6 month study without the previous bed-time insulin injection . The insulin and metformin doses were not changed throughout the study . Results After 6 months , the fasting glucose , insulin , C-peptide , fructosamine , and HbA1c levels were not significantly different from baseline values . In addition , changes in these parameters ( values at 6 months minus values at baseline ) did not differ between the vitamin D and the placebo group . Conclusions We were not able to demonstrate that vitamin D supplementation had a significant effect on glucose metabolism in subjects with type 2 diabetes but without vitamin D deficiency . Further studies are needed in larger groups of subjects with type 2 diabetes or impaired glucose tolerance , who also exhibit low serum 25-hydroxyvitamin D levels",
"Objective The authors investigated the effects of exogenous growth hormone ( GH ) on protein accretion and the composition of weight gain in a group of stable , nutritionally compromised postoperative patients receiving st and ard hypercaloric nutritional therapy . Summary Background Data A significant loss of body protein impairs normal physiologic functions and is associated with increased postoperative complications and prolonged hospitalization . Previous studies have demonstrated that st and ard methods of nutritional support enhance the deposition of fat and extracellular water but are ineffective in repleting body protein . Methods Fourteen patients requiring long-term nutritional support for severe gastrointestinal dysfunction received st and ard nutritional therapy ( STD ) providing approximately 50 kcal/kg/day and 2 g of protein/kg/day during an initial 7-day equilibrium period . The patients then continued on STD ( n = 4 ) or , in addition , received GH 0.14 mg/kg/day ( n = 10 ) . On day 7 of the equilibrium period and again after 3 weeks of treatment , the components of body weight were determined ; these included body fat , mineral content , lean ( nonfat and nonmineral-containing tissue ) mass , total body water , extracellular water ( ECW ) , and body protein . Daily and cumulative nutrient balance and substrate oxidation studies determined the distribution , efficiency , and utilization of calories for protein , fat , and carbohydrate deposition . Results The GH-treated patients gained minimal body fat but had significantly more lean mass ( 4.311 ± 0.6 kg vs. 1.988 ± 0.2 kg , p ≤ 0.03 ) and more protein ( 1.417 ± 0.3 kg vs. 0.086 ± 0.1 kg , p ≤ 0.03 ) than did the STD-treated patients . The increase in lean mass was not associated with an inappropriate expansion of ECW . In contrast , patients receiving STD therapy tended to deposit a greater proportion of body weight as ECW and significantly more fat than did GH-treated patients ( 1.004 ± 0.3 kg vs. 0.129 ± 0.2 kg , p 0.05 ) . GH administration altered substrate oxidation ( respiratory quotient = 0.94 ± 0.02 GH vs. 1.17 ± 0.05 STD , p ≤ 0.0002 ) and the use of available energy , result ing in a 66 % increase in the efficiency of protein deposition ( 13.37 ± 0.8 g/1000 kcal vs. 8.04 g ± 3.06 g/1000 kcal , p ± 0.04 ) . Conclusions GH administration accelerated protein gain in stable adult patients receiving aggressive nutritional therapy without a significant increase in body fat or a disproportionate expansion of ECW . GH therapy accelerated nutritional repletion and , therefore , may shorten the convalescence of the malnourished patient requiring a major surgical procedure",
"BACKGROUND Vitamin D deficiency is common in older population s , particularly during the winter months due to low levels of ultraviolet light exposure , and in nursing home residents . OBJECTIVE The main objective of the current study was to assess the distribution of serum 25-hydroxyvitamin D and its correlates in a sample of men and women with recent hip fractures who were part of a large clinical trial . METHODS This was a cross-sectional exploratory study of screened and ultimately r and omized patients with hip fractures . They were part of a multinational ( 115 clinical centers in 20 countries ) , r and omized , placebo-controlled , double-blind study testing the efficacy of a yearly IV bisphosphonate ( zoledronic acid ) in the prevention of new clinical fractures in patients with recent hip fracture repair . Levels of 25-hydroxyvitamin D , calcium , alkaline phosphatase , creatinine clearance , and albumin were measured at a screening visit using blood serum . Demographic variables were assessed by patient self-report . Bone mineral density ( BMD ) was assessed by dual-energy x-ray absorptiometry of the nonfractured hip . RESULTS This report included 1174 screened patients ( 526 with vitamin D measured ) and 655 ( 385 with vitamin D measured ) patients r and omized before the protocol amendment . In screened patients , levels of 25-hydroxyvitamin D were low ( median , 14.7 ng/mL ; interquartilc range , 7.6 , 21.65 ) . Overall , 51 % were at or below the clinical ly meaningful threshold of 15 ng/mL. Among those patients r and omized , the level of 25-hydroxyvitamin D was significantly positively related to male sex ( rho , 0.13 ; P serum calcium ( rho , 0.16 ; P BMD at the femoral neck ( rho , 0.22 ; P Low serum 25-hydroxyvitamin D ( low serum calcium ( odds ratio , 0.16 ; 95 % CI , 0.05 - 0.52 ) in multivariable logistic models controlling for sex , age , race , body mass index , living at home , alkaline phosphatase , and creatinine clearance . CONCLUSIONS We concluded that vitamin D insufficiency was a common problem in this population of elderly patients who had recently suffered a hip fracture . This insufficiency was related only to serum calcium in multivariable controlled models but can not be reliably identified or excluded by measuring serum calcium alone . Physicians should be encouraged to check and monitor patients ' serum levels of 25-hydroxyvitamin",
"Dexfenfluramine ( dF ) was compared to placebo as adjuvant to a very energy-restricted diet ( 1.6 - 4.2 MJ/24 h ) . The diet was continued as long as possible or until a satisfactory weight loss had been achieved , and dietary efforts were continued throughout the study . Of the 37 females and five males included , 71 per cent could be followed up for 12 months . Initial BMI ranged from 28 to 54 kg/m2 . The lowest body weight was reached 1 month earlier in the dF group ( P = 0.037 ) . Throughout the study , the reduction of excess weight ( REW ) was greater in dF patients ( P less than 0.05 only at 4 and 6 months ) . At 6 months , excess weight had declined by 15 per cent more in the dF group than in the placebo group ( 95 per cent confidence limits of the median being 1 - 31 per cent ) . Between 6 and 12 months , both groups regained weight significantly , the rates of regain differing only insignificantly . At 12 months , excess weight showed a net decrease of only 8 per cent more in the dF group than in the placebo group ( 95 per cent confidence limits being -7 to + 24 per cent ) . Therefore , REW showed no significant group difference after 12 months . Type of obesity ( and roid or gynoid ) as determined by waist to hip ratio had no significant impact on either weight loss , REW , reductions of waist and hip circumferences , or on waist to hip ratio changes . S-alkaline phosphatases and s-uric acid declined significantly in the dF group only . Side-effects were all mild and their prevalence showed no group difference . ( ABSTRACT TRUNCATED AT 250 WORDS",
"BACKGROUND : A central distribution of adipose tissue is frequently associated with cardiovascular disease ( CVD ) and its risk factors . METHODS : Clinical usefulness of waist-to-hip ratio ( WHR ) for predicting the risk of cardiovascular events , estimated with models based on data from the Framingham and Prospect i ve Cardiovascular Münster ( PROCAM ) studies was evaluated . SUBJECTS : These were 552 men and 160 women , asymptomatic and at risk for CVD , aged 30–74 y , recruited from an ongoing risk factor screening program conducted at worksites . RESULTS : Abdominal fatness was a strong predictor of cardiovascular complications in subjects whose WHR was in the top quintile ( > 0.98 for men and > ; 0.91 for women ) . The estimated percentage rate of coronary heart disease ( CHD , P and death ( P myocardial infa rct ion ( P stroke ( P total CVD ( P death ( P developing a coronary event over the next 10 y was more than two-fold greater ( odds ratio ( OR ) 2.60 ( confidence intervals ( CI ) 1.09–6.54 ) than in the lowest WHR quintiles . Similar six-year myocardial infa rct ion ( MI ) risks at each quintile of WHR were observed in men in both Framingham and PROCAM models . In the overall population , CHD estimates increased with increasing quintiles of WHR with the Framingham model and an adapted model for estimating probabilities of disease in the French population of the Prévention Cardiovasculaire en Médecine du Travail ( PCV-METRA ) group . CONCLUSION : Abdominal deposition of fat assessed by WHR may be of strong clinical value for predicting high risk of cardiovascular events ",
"OBJECTIVES Aging is associated with changes in resting energy expenditure ( REE ) and body composition . We investigated the association between age and changes in REE in men and women stratified by body mass index ( BMI ) categories ( normal weight , overweight and obesity ) . We also examined whether the age-related decline in REE was explained by concomitant changes in body composition and lifestyle factors . STUDY DESIGN Cross-sectional . MAIN OUTCOME MEASURES 3442 adult participants ( age range : 18 - 81 y ; men/women : 977/2465 ) were included . The BMI range was 18.5 - 60.2 kg/m(2 ) . REE was measured by indirect calorimetry in fasting conditions and body composition by bioelectrical impedance . Regression models were used to evaluate age-related changes in REE in subjects stratified by sex and BMI . Models were adjusted for body composition ( fat mass , fat free mass ) , smoking , disease count and physical activity . RESULTS In unadjusted models , the rate of decline in REE was highest in obese men ( slope=-8.7±0.8 kcal/day/year ) whereas the lowest rate of decline was observed in normal weight women ( -2.9±0.3 kcal/day/year ) . Gender differences were observed for the age of onset of REE adaptive changes ( i.e. , not accounted by age related changes in body composition and lifestyle factors ) . In women , adaptive changes appeared to occur in middle-age ( ∼47 y ) across all BMI groups whereas changes seemed to be delayed in obese men ( ∼54 y ) compared to overweight ( ∼43 y ) and normal weight ( ∼39 y ) men . CONCLUSIONS Sex and BMI influenced the rate and degree of the age-related decline in REE . Critical age windows have been identified for the onset of putative mechanisms of energy adaptation . These findings require confirmation in prospect i ve studies",
"BACKGROUND Fat accumulation in nonadipose tissue is linked to insulin resistance and metabolic diseases . Earlier studies have shown that hepatic lipid accumulation can occur after 4 d of a high-fat diet in humans , and this fat accumulation can be blunted by the ingestion of additional proteins . OBJECTIVES In this study , we explored whether a single high-fat meal increased the lipid content in liver and skeletal muscle as measured by using in vivo proton magnetic resonance spectroscopy ( ¹H-MRS ) and whether the addition of protein can modulate the postpr and ial ectopic lipid storage . DESIGN Intrahepatic lipid ( IHL ) and intramyocellular lipid ( IMCL ) concentrations were determined by using ¹H-MRS before and 3 and 5 h after a high-fat with added protein meal ( 61.5 % of energy from fat ) or a high-fat without added protein meal ( mean ± SEM : 51.1 ± 7.9 g of protein ; 191.9 ± 9.9 kcal added ) in a r and omized crossover study . IHL and IMCL concentrations were converted to absolute concentrations ( g/kg wet weight ) by using water as an internal reference . RESULTS Nine lean , healthy subjects [ 6 men and 3 women ; mean ( ±SD ) age : 22.7 ± 3.0 y ; mean body mass index ( in kg/m² ) : 21.8 ± 1.8 ] were included in this study . IHL concentrations increased ∼20 % ( P contrast , IMCL concentrations were not altered during the postpr and ial period ( P = 0.74 ) . The addition of protein to a single high-fat meal did not change the postpr and ial accumulation of fat in the liver ( P = 0.93 ) or skeletal muscle ( P = 0.84 ) . CONCLUSIONS In this study , we showed that a single energy-dense , high-fat meal induced net lipid accumulation in the liver , which was detected by using in vivo ¹H-MRS . This noninvasive approach might bring new opportunities to study postpr and ial hepatic lipid dynamics . The addition of protein did not change the ectopic lipid retention after a single high-fat meal",
"The authors investigated the association of adherence to Mediterranean diet with colorectal cancer ( CRC ) risk in the European Prospect i ve Investigation into Cancer and nutrition study . Adherence to Mediterranean diet was expressed through two 10-unit scales , the Modified Mediterranean diet score ( MMDS ) and the Centre-Specific MMDS ( CSMMDS ) . Both scales share the same dietary components but differ in the cut-off values that were used for these components in the construction of the scales . Adjusted hazard ratios ( HR ) for the associations of these scales with CRC incidence were estimated . After 5,296,617 person-years of follow-up , 4,355 incident CRC cases were identified . A decreased risk of CRC , of 8 and 11 % was estimated when comparing the highest ( scores 6–9 ) with the lowest ( scores 0–3 ) adherence to CSMMDS and MMDS respectively . For MMDS the HR was 0.89 ( 95 % confidence interval ( CI ) : 0.80 , 0.99 ) . A 2-unit increment in either Mediterranean scale was associated with a borderline statistically significant 3 to 4 % reduction in CRC risk ( HR for MMDS : 0.96 ; 95 % CI : 0.92 , 1.00 ) . These associations were somewhat more evident , among women , were mainly manifested for colon cancer risk and their magnitude was not altered when alcohol was excluded from MMDS . These findings suggest that following a Mediterranean diet may have a modest beneficial effect on CRC risk",
"RATIONALE Although vitamin D is widely used to promote skeletal health , definitive data on benefits and risks of supplemental vitamin D alone on bone are lacking . Results from large , r and omized controlled trials in the general population are sparse . Data on the effects of supplemental omega-3 fatty acids ( FAs ) on bone are also limited . DESIGN The VITamin D and OmegA-3 TriaL ( VITAL ) is a double-blind , placebo-controlled trial assessing the role of vitamin D3 ( 2000 IU/d ) and omega-3 FA ( 1g/d ) supplements in reducing risks of cancer and cardiovascular disease among U.S. men aged ≥50 and women aged ≥55 . To comprehensively test effects of supplemental vitamin D and /or omega-3 FAs on skeletal health , the VITAL : Effects on Fractures ancillary study is determining the effects of these supplements on incident fractures among 25,875 participants enrolled in the parent trial . Study investigators adjudicate fractures through a detailed review of medical records and radiological images ( hip and femur ) . In a complementary ancillary , VITAL : Effects on Structure and Architecture is determining the effects of supplemental vitamin D and /or omega-3 FAs on bone with detailed phenotyping during in-person visits . Comprehensive assessment s of bone density , turnover , structure/architecture , body composition , and physical performance are being performed at baseline and 2 years post-r and omization . CONCLUSION Results from these studies will clarify the relationship between supplemental vitamin D and /or omega-3 FAs on bone health outcomes , and inform clinical care and public health guidelines on the use of supplemental vitamin D for the primary prevention of fractures in women and men",
"African Americans have a disproportionate burden of inflammation-associated chronic diseases such as cancer and lower circulating levels of 25-hydroxyvitamin D [ 25(OH)D ] . The effect of vitamin D3 ( cholecalciferol ) supplementation on inflammatory markers is uncertain . We conducted a r and omized , double-blind , placebo-controlled trial of supplemental oral vitamin D ( placebo , 1,000 , 2,000 , or 4,000 IU/day of vitamin D3 orally for 3 months ) in 328 African Americans ( median age , 51 years ) of public housing communities in Boston , MA , who were enrolled over three consecutive winter periods ( 2007–2010 ) . Change from 0 to 3 months of plasma levels of 25(OH)D , high-sensitivity C-reactive protein ( CRP ) , interleukin (IL)-6 , IL-10 , and soluble TNF-α receptor type 2 ( sTNF-R2 ) in 292 ( 89 % ) participants were measured . Overall , no statistically significant changes in CRP , IL-6 , IL-10 , and sTNF-R2 were observed after the vitamin D supplementation period . Baseline CRP was significantly inversely associated with the baseline 25(OH)D level ( P between baseline 25(OH)D and vitamin D supplementation was observed for outcome change in log CRP ( month 3–month 0 ; P for interaction = 0.04 ) . Within an unselected population of African Americans , short-term exposure to vitamin D supplementation produced no change in circulating inflammatory markers . This study confirms the strong independent association of CRP with 25(OH)D status even after adjusting for body mass index . Future studies of longer supplemental vitamin D3 duration are necessary to examine the complex influence of vitamin D3 on CRP and other chronic inflammatory cytokines for possible reduction of cancer health disparities in African Americans . Cancer Prev Res ; 7(2 ) ; 218–25 . © 2013 AACR",
"BACKGROUND Inadequate dietary intake of calcium and vitamin D may contribute to the high prevalence of osteoporosis among older persons . METHODS We studied the effects of three years of dietary supplementation with calcium and vitamin D on bone mineral density , biochemical measures of bone metabolism , and the incidence of nonvertebral fractures in 176 men and 213 women 65 years of age or older who were living at home . They received either 500 mg of calcium plus 700 IU of vitamin D3 ( cholecalciferol ) per day or placebo . Bone mineral density was measured by dual-energy x-ray absorptiometry , blood and urine were analyzed every six months , and cases of nonvertebral fracture were ascertained by means of interviews and verified with use of hospital records . RESULTS The mean ( + /-SD ) changes in bone mineral density in the calcium-vitamin D and placebo groups were as follows : femoral neck , + 0.50+/-4.80 and -0.70+/-5.03 percent , respectively ( P=0.02 ) ; spine,+2.12+/-4.06 and + 1.22+/-4.25 percent ( P=0.04 ) ; and total body , + 0.06+/-1.83 and -1.09+/-1.71 percent ( P calcium-vitamin D and placebo groups was significant at all skeletal sites after one year , but it was significant only for total-body bone mineral density in the second and third years . Of 37 subjects who had nonvertebral fractures , 26 were in the placebo group and 11 were in the calcium-vitamin D group ( P=0.02 ) . CONCLUSIONS In men and women 65 years of age or older who are living in the community , dietary supplementation with calcium and vitamin D moderately reduced bone loss measured in the femoral neck , spine , and total body over the three-year study period and reduced the incidence of nonvertebral fractures",
"BACKGROUND Obesity in the United States has increased significantly during the past several decades . The role of calcium in the maintenance of a healthy body weight remains controversial . METHODS A r and omized , double-blinded , placebo-controlled trial was performed with 36 282 postmenopausal women , aged 50 to 79 years , who were already enrolled in the dietary modification and /or hormone therapy arms of the Women 's Health Initiative clinical trial . Women were r and omized at their first or second annual visit to receive a dose of 1000 mg of elemental calcium plus 400 IU of cholecalciferol ( vitamin D ) or placebo daily . Change in body weight was ascertained annually for an average of 7 years . RESULTS Women receiving calcium plus cholecalciferol supplements vs women receiving placebo had a minimal but consistent favorable difference in weight change ( mean difference , -0.13 kg ; 95 % confidence interval , -0.21 to -0.05 ; P = .001 ) . After 3 years of follow-up , women with daily calcium intakes less than 1200 mg at baseline who were r and omized to supplements were 11 % less likely to experience small weight gains ( 1 - 3 kg ) and 11 % less likely to gain more moderate amounts of weight ( > 3 kg ) ( P for interaction for baseline calcium intake = .008 ) . CONCLUSION Calcium plus cholecalciferol supplementation has a small effect on the prevention of weight gain , which was observed primarily in women who reported inadequate calcium intakes . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000611",
"Experimental evidence suggests a specific role for the active metabolite of vitamin D ( 1,25(OH)2D3 ) in insulin secretion . In order to evaluate the possible clinical significance , 65 middle-aged men with impaired glucose tolerance , and normal serum levels of vitamin D metabolites , were enrolled in a three-month study where they were given either 0.75 micrograms alpha-calcidol ( 1 alpha(OH)D3 ) daily or placebo . Indices of glucose and lipid metabolism were evaluated before and after treatment . There were no significant changes during the trial neither for fasting blood glucose , hemoglobin A1c or for the intravenous glucose tolerance between the treatment and the placebo groups , nor were there any consistent changes in insulin values during the glucose tolerance test . Subjects treated with alpha-calcidol displayed a significant reduction in body weight with an average of 1.1 kg , while those receiving placebo lost no weight . Treatment did not affect the serum lipoprotein values . Thus , a modest dose of active vitamin D , which did not cause elevation of serum calcium , did not provide general improvement of glucose tolerance or of insulin secretion when given to patients with impaired glucose tolerance , but without vitamin D deficiency , over a three-month period",
"AIM To determine the short-term effect of vitamin D(3 ) supplementation on insulin sensitivity in apparently healthy , middle-aged , central ly obese men . SUBJECTS AND METHODS A double-blind r and omized controlled trial was conducted at a tertiary care facility in which 100 male volunteers aged > or = 35 years received three doses of vitamin D(3 ) ( 120,000 IU each ; supplemented group ) fortnightly or placebo ( control group ) . Hepatic fasting insulin sensitivity [ homeostasis model assessment ( HOMA ) , quantitative insulin-sensitivity check index , HOMA-2 ] , postpr and ial insulin sensitivity [ oral glucose insulin sensitivity ( OGIS ) ] , insulin secretion ( HOMA%B , HOMA2-%B ) , lipid profile and blood pressure were measured at baseline and at 6 weeks ' follow-up . RESULTS Seventy-one of the recruited subjects completed the study ( 35 in supplemented group , 36 in control group ) . There was an increase in OGIS with supplementation by per protocol analysis ( P = 0.038 ; intention-to-treat analysis P = 0.055 ) . The age- and baseline 25-hydroxyvitamin D level-adjusted difference in change in OGIS was highly significant ( mean difference 41.1 + /- 15.5 ; P = 0.01 ) . No changes in secondary outcome measures ( insulin secretion , basal indices of insulin sensitivity , blood pressure or lipid profile ) were found with supplementation . CONCLUSION The trial indicates that vitamin D(3 ) supplementation improves postpr and ial insulin sensitivity ( OGIS ) in apparently healthy men likely to have insulin resistance ( central ly obese but non-diabetic )",
"BACKGROUND Serum 25-hydroxyvitamin D ( 25-[OH]D ) is considered the best biomarker of clinical vitamin D status . OBJECTIVE To determine the effect of increasing oral doses of vitamin D(3 ) on serum 25-(OH)D and serum parathyroid hormone ( PTH ) levels in postmenopausal white women with vitamin D insufficiency ( defined as a 25-[OH]D level ≤50 nmol/L ) in the presence of adequate calcium intake . These results can be used as a guide to estimate the Recommended Dietary Allowance ( RDA ) ( defined as meeting the needs of 97.5 % of the population ) for vitamin D(3 ) . DESIGN R and omized , placebo-controlled trial . ( Clinical Trials.gov registration number : NCT00472823 ) SETTING Creighton University Medical Center , Omaha , Nebraska . PARTICIPANTS 163 healthy postmenopausal white women with vitamin D insufficiency enrolled in the winter or spring of 2007 to 2008 and followed for 1 year . INTERVENTION Participants were r and omly assigned to receive placebo or vitamin D(3 ) , 400 , 800 , 1600 , 2400 , 3200 , 4000 , or 4800 IU once daily . Daily calcium supplements were provided to increase the total daily calcium intake to 1200 to 1400 mg . MEASUREMENTS The primary outcomes were 25-(OH)D and PTH levels at 6 and 12 months . RESULTS The mean baseline 25-(OH)D level was 39 nmol/L. The dose response was curvilinear and tended to plateau at approximately 112 nmol/L in patients receiving more than 3200 IU/d of vitamin D(3 ) . The RDA of vitamin D(3 ) to achieve a 25-(OH)D level greater than 50 nmol/L was 800 IU/d . A mixed-effects model predicted that 600 IU of vitamin D(3 ) daily could also meet this goal . Compared with participants with a normal body mass index ( 25-(OH)D level that was 17.8 nmol/L lower . Parathyroid hormone levels at 12 months decreased with an increasing dose of vitamin D(3 ) ( P = 0.012 ) . Depending on the criteria used , hypercalcemia occurred in 2.8 % to 9.0 % and hypercalciuria in 12.0 % to 33.0 % of participants ; events were unrelated to dose . LIMITATION Findings may not be generalizable to other age groups or persons with substantial comorbid conditions . CONCLUSION A vitamin D(3 ) dosage of 800 IU/d increased serum 25-(OH)D levels to greater than 50 nmol/L in 97.5 % of women ; however , a model predicted the same response with a vitamin D(3 ) dosage of 600 IU/d . These results can be used as a guide for the RDA of vitamin D(3 ) , but prospect i ve trials are needed to confirm the clinical significance of these results . PRIMARY FUNDING SOURCE National Institute on Aging",
"BACKGROUND AND AIM Cross-sectional studies indicate vitamin D to be of importance for glucose tolerance , blood pressure and serum lipids , but whether supplementation with vitamin D would improve cardio-vascular risk factors is not known . DESIGN AND SETTING The study was a 1 year , double blind placebo-controlled intervention trial performed at the University Hospital of North Norway from November 2005 to October 2007 . Subjects . A total of 438 overweight or obese subjects , 21 - 70 years old , were included and 330 completed the study . INTERVENTIONS The subjects were r and omized to vitamin D ( cholecalciferol , vitamin D(3 ) ) 40 000 IU per week ( DD group ) , vitamin D 20 000 IU per week ( DP group ) , or placebo ( PP group ) . All subjects were given 500 mg calcium daily . MAIN OUTCOME MEASURES Fasting serum lipids and blood pressure were measured and an oral glucose tolerance test performed at start and end of the study . RESULTS At baseline the mean serum 25(OH)D levels were 58 nmol L(-1 ) ( all subjects ) and increased to 140 and 101 nmol L(-1 ) in the DD and DP groups , respectively . No significant differences were found between the three groups regarding change in measures of glucose metabolism or serum lipids . In the DP group , there was a slight but significant increase in systolic blood pressure compared with the placebo group . CONCLUSIONS Our results do not support a positive effect of vitamin D on glucose tolerance , blood pressure or serum lipids . Further studies in subjects with low serum 25(OH)D levels combined with impaired glucose tolerance , hypertension or dyslipidaemia are needed"
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Obesity is associated with increased risk for cardiovascular ( CV ) disease ( CVD ) and CV mortality . Bariatric surgery has been shown to resolve or improve CVD risk factors , to varying degrees . The objective of this systematic review was to determine the impact of bariatric surgery on CV risk factors and mortality . A systematic review of the published research was performed to evaluate evidence regarding CV outcomes in morbidly obese bariatric patients . Two major data bases ( PubMed and the Cochrane Library ) were search ed . The review included all original reports reporting outcomes after bariatric surgery , published in English , from January 1950 to July 2010 . In total , 637 studies were identified from the initial screen . After applying inclusion and exclusion criteria , 52 studies involving 16,867 patients were included ( mean age 42 years , 78 % women ) . The baseline prevalence of hypertension , diabetes , and dyslipidemia was 49 % , 28 % , and 46 % , respectively . Mean follow-up was 34 months ( range 3 to 155 ) , and the average excess weight loss was 52 % ( range 16 % to 87 % ) . Most studies reported significant decreases postoperatively in the prevalence of CV risk factors , including hypertension , diabetes , and dyslipidemia . Mean systolic pressure reduced from to 139 to 124 mm Hg and diastolic pressure from 87 to 77 mm Hg . C-reactive protein decreased , endothelial function improved , and a 40 % relative risk reduction for 10-year coronary heart disease risk was observed , as determined by the Framingham risk score . In conclusion , this review highlights the benefits of bariatric surgery in reducing or eliminating risk factors for CVD . It provides further evidence to support surgical treatment of obesity to achieve CVD risk reduction | [
"OBJECTIVES The aim of this study was to examine the association between brachial artery flow-mediated dilation ( FMD ) and cardiovascular events in a cohort of initially asymptomatic post-menopausal women , with adjustment for the presence of the major cardiovascular risk factors . BACKGROUND Conventional major cardiovascular risk factors ( cigarette smoking , hypercholesterolemia , hypertension , and diabetes ) fail to explain nearly 50 % of cardiovascular events . Defining the magnitude of future risk for the development of clinical events is a major focus of effective primary prevention . Evaluation of endothelial function , utilizing the noninvasive measurement of the brachial artery FMD , may serve as a screening tool to individualize high-risk patients . METHODS We conducted a prospect i ve study on 2,264 post-menopausal women , age 54 + /- 6 years . The length of the follow-up was 45 + /- 13 months ( range 6 to 65 months ) . RESULTS During observation , 90 major events were recorded . Risk-adjusted relative risk values result ed 1.0 , 1.33 ( 95 % confidence interval [ CI ] 1.09 to 4.09 ) , and 4.42 ( 95 % CI 2.97 to 8.01 ) for women in the higher , intermediate , and lower tertile of FMD , respectively ( p event rate for women in the lower tertile ( FMD cardiovascular events ( likelihood ratio chi-square change : 10.22 ; p post-menopausal women , the knowledge of FMD provided incremental prognostic information regarding the risk of developing cardiovascular events",
"Background Laparoscopic Roux-en-Y gastric bypass ( LRYGB ) surgery is known to have a significant effect on obesity-related comorbidities such as hypertension curing it in some ( 50–70 % ) while improving control in others . Our aim was to observe the changes in blood pressure ( BP ) in a cohort of 100 patients followed prospect ively for 1 year after LRYGB . Methods BP measurements were recorded prospect ively in 100 consecutive patients preoperatively and then postoperatively at weeks 1 , 5 , 9 , and months 6 and 12 . In order to reduce bias , three BP measurements were made by the same nurse at each office visit and the mean recorded . Pre- and postoperative usage of antihypertensive medication was also noted . Results Eighty-nine women and 11 men underwent LRYGB and their BP monitored for 1 year . There was an 85 % follow-up rate with mean % excess body weight loss of 60 . Reductions in systolic ( 9 mmHg ) and diastolic ( 7 mmHg ) BP measurements were seen as early as week 1 postoperatively and maintained for the duration of the observation period ( P postoperative usage of antihypertensive medication is reduced to a third of preoperative use . Conclusion LRYGB is associated with an early reduction in BP and antihypertensive medication usage which is maintained at 1 year after surgery . This early impact on blood pressure occurs before any significant weight loss is achieved thereby suggesting a hormonal mechanism that may be involved for the changes observed",
"Background Obesity has been widely recognized as a chronic inflammatory condition and associated with elevated inflammatory indicators including C-reactive protein ( CRP ) and white blood cell count ( WBC ) . Recent studies have shown elevated CRP or WBC is a significant risk factor for cardiac events and stroke but the clinical significance of CRP and WBC has not been clearly studied in morbidly obese patients . This study is aim ed at the clinical significance of WBC and CRP in morbidly obese patients and the change after bariatric surgery . Methods The study was a prospect ively controlled clinical study . From December 1 , 2001 to January 31 , 2006 , of 640 ( 442 females and 198 males ) consecutive morbid obese patients enrolled in a surgically supervised weight loss program with at least 1 year ’s follow-up were examined . Results Of the patients , 476 ( 74.4 % ) had elevated CRP and 100 ( 15.6 % ) had elevated WBC at preoperative study . CRP and WBC were significantly related and both increased with increasing body mass index ( BMI ) . CRP is also increased with increasing waist , glucose level , hemoglobin , albumin , Ca , insulin , C-peptide , and metabolic syndrome while WBC is increased with metabolic syndrome but decreased with increasing age . Multivariate analysis confirmed fasting glucose level and hemoglobin are independent predictors of the elevation of CRP while age is the only independent predictor for elevated WBC . Both WBC and CRP levels decreased rapidly after obesity surgery . These improvements result ed in a 69.8 % reduction of CRP and 26.4 % reduction of WBC 1 year after surgery . Although individuals who underwent laparoscopic gastric bypass lost significantly more weight ( 36.8 ± 11.7 kg vs. 17.3 ± 10.8 kg ; p = 0.000 ) and achieved a lower BMI ( 27.8 ± 4.6 vs. 35.0 ± 5.5 ; p = 0.000 ) than individuals who underwent laparoscopic gastric b and ing , there was no difference in the resolution of elevated CRP 1 year after surgery ( 95.9 % vs. 84.5 % ; p = 0.169 ) and WBC ( 99.4 % vs. 98.3 % ; p = 0.323 ) . Conclusions Both baseline WBC and CRP are elevated in morbid obese patients but CRP has a better clinical significance . Significant weight reduction 1 year after surgery markedly reduced CRP and WBC with a resolution rate of 93.9 % and 98.2 % separately . Obesity surgery performed by laparoscopic surgery is recommended for obese patients with elevated CRP or WBC",
"OBJECTIVES To compare the potential years of life saved ( YOLS ) associated with risk factor modification in the primary and secondary prevention of cardiovascular disease ( CVD ) . METHODS The CVD life expectancy model estimates the risk of death due to coronary disease , stroke , and other causes based on the levels of independent risk factors ( such as age , blood pressure , and blood lipid levels ) found in the cohort of the Lipid Research Clinics . The model was vali date d by comparing its predictions with the observed fatal outcomes of 9 r and omized clinical trials . We then estimated the YOLS associated with treating hyperlipidemia or hypertension among hypothetical patient groups with and without CVD at baseline . We defined high-risk patients as those with 3 risk factors ( hyperlipidemia , cigarette smoking , and hypertension ) and low-risk patients as those with isolated hypertension or hyperlipidemia . RESULTS The fatal events predicted by the model were consistent with the clinical trial results . Among men and women with hyperlipidemia without CVD , the forecasted benefits of lipid therapy were substantially greater among high-risk groups vs low-risk groups ( 4.74 - 0.78 YOLS vs 2.50 - 0.25 YOLS , respectively ) . Among those with CVD , the forecasted benefits of treatment were similar for both high-risk and low-risk groups ( 4.65 - 0.65 YOLS vs 3.84 - 0.58 YOLS , respectively ) . The results for hypertension therapy also demonstrated greater benefits for high-risk vs low-risk patients undergoing primary prevention therapy ( 1.34 - 0.29 YOLS vs 0.85 - 0.13 YOLS , respectively ) , and the forecasted benefits in secondary prevention were similar ( 1.26 - 0.23 YOLS vs 1.00 - 0.23 YOLS , respectively ) . CONCLUSIONS The clinical approach to risk factor modification in primary prevention should be different from that in secondary prevention . The forecasted benefits of therapy among patients without CVD are greatest in the presence of other risk factors . Among those with CVD , the benefits of therapy are equivalent , thereby obviating the need to target high-risk patients",
"This study was design ed to assess the effects of bariatric weight loss surgery on structural , functional , and inflammatory markers of coronary atherosclerosis . Obesity is a worldwide epidemic and an independent risk factor for coronary atherosclerosis . It remains unclear whether surgically induced weight loss reduces cardiovascular risk . This prospect i ve study enrolled 50 consecutive subjects with morbid obesity who underwent Roux-en-Y gastric bypass surgery ( GBS ) after failed attempts at medical weight loss . Subjects were recruited through a comprehensive weight loss center affiliated with an academic tertiary care hospital . All subjects had body mass indexes > or = 40 kg/m(2 ) or body mass indexes of 35 to 40 kg/m(2 ) with > or = 2 co-morbid obesity-related conditions . Markers of coronary atherosclerosis , including brachial artery flow-mediated dilation , carotid intima-media thickness , and high-sensitivity C-reactive protein , were measured before GBS and 6 , 12 , and 24 months after GBS . There were statistically significant improvements in all measured markers of coronary atherosclerosis after GBS . The mean body mass index decreased from 47 to 29.5 kg/m(2 ) at 24 months ( p mean carotid intima-media thickness regressed from 0.84 to 0.50 mm at 24 months ( p mean flow-mediated dilation improved from 6.0 % to 14.9 % at 24 months ( p mean high-sensitivity C-reactive protein decreased from 1.23 to 0.65 mg/dl at 6 months ( p GBS results in significant improvements in inflammatory , structural , and functional markers of coronary atherosclerosis",
"Background : The objective of this study was to determine the weight loss , changes in co-morbidities , medication usage and general health status at 1 year after laparoscopic adjustable gastric b and ing ( LAGB ) . Methods : Prospect i ve data were obtained from all subjects undergoing LAGB . These measurements included a medical history and review of systems , medications , height and weight and the SF-36 general health survey . Patients were seen for b and adjustments as needed throughout the year . At the 1-year follow-up visit , patients were weighed and interviewed about the status of their health conditions and their current medications , and the SF-36 was repeated . Results : Between November 2002 and November 2003 , 195 patients had LAGB . The majority of subjects were female ( 82.8 % ) , married ( 65.1 % ) , and white ( 94.9 % ) . Complications occurred in 18 subjects ( 9.2 % ) . These included 3 slipped b and s ( 1.5 % ) , 4 port problems ( 2.1 % ) , 8 patients with temporary stoma occlusion ( 4.1 % ) , 1 explantation ( 0.5 % ) , and 1 mortality ( 0.5 % ) . Mean BMI decreased from 45.8 kg/m2 ( ± 7.7 ) to 32.3 kg/m2 ( ± 7.0 ) . Mean percent excess body weight lost was 45.7 % ( ± 17.1 ) during the first year . Major improvements occurred in arthritis , asthma , depression , diabetes , gastro-esophageal reflux disease , hyperlipidemia , hypertension , joint and back pain , sleep apnea and stress incontinence . Medication usage declined remarkably . Quality of life ( QoL ) by the SF-36 showed highly significant improvements . Conclusions : At 1 year after LAGB , patients had experienced significant weight loss , resolution of comorbidities , decreases in medication usage , and improvements in",
"BACKGROUND Roux-en-Y gastric bypass is currently considered the gold st and ard surgical option for the treatment of morbid obesity . Open RYGB is associated with a high risk of complications . Laparoscopic RYGB has been shown to reduce perioperative morbidity and improve recovery . OBJECTIVES To review our experience with laparoscopic RYGB during a 19 month period . METHODS The data were collected prospect ively . The study group comprised all patients who underwent laparoscopic RYGB for treatment of morbid obesity as their primary operation between February 2006 and July 2007 . The reported outcome included surgical results , weight loss , and improved status of co-morbidities , with follow-up of up to 19 months . RESULTS The mean age of the 50 patients was 36.7 years . Mean body mass index was 44.7 kg/m2 ( range 35 - 76 kg/m2 ) ; mean duration of surgery was 171 minutes . There was no conversion to open surgery . The mean length of stay was 4 days ( range 2 - 7 days ) . Five patients ( 10 % ) developed a complication , but none of them required early reoperation and there were no deaths . Mean follow-up was 7 months ( range 40 days-19 months ) . The excess body weight loss was 55 % and 61 % at 6 and 12 months respectively . Diabetes resolved completely or significantly improved in all five patients with this condition , as did hypertension in eight patients out of nine . CONCLUSIONS Laparoscopic RYGB is feasible and safe . The results in terms of weight loss and correction of co-morbidities are comparable to other previously published studies . However , only surgeons with experience in advanced laparoscopic as well as bariatric surgery should attempt this procedure",
"HYPOTHESIS Outcome following laparoscopic adjustable gastric b and ing ( LAGB ) in super morbidly obese patients is significantly worse compared with the st and ard laparoscopic Roux-en-Y gastric bypass ( LRYGB ) . DESIGN Prospect i ve case series . SETTING Community teaching hospital ( 490 beds ) . PATIENTS A prospect ively maintained data base identified patients who underwent operative treatment for morbid obesity between February 2001 and June 2004 . The study group included super morbidly obese patients ( body mass index > 50 [ calculated as weight in kilograms divided by the square of height in meters ] ) following LAGB and LRYGB . INTERVENTIONS Among 106 patients with super morbid obesity , 60 ( 57 % ) and 46 ( 43 % ) underwent LAGB and LRYGB , respectively . MAIN OUTCOME MEASURES Patient demographics , weight loss , percentage of excess weight loss , change in body mass index , early ( or = 30 days ) complications , reoperations , medical comorbidity , and patient satisfaction were studied . Analysis was performed using the t test and Pearson chi 2 analysis . RESULTS Overall median follow-up was 16.2 months ( range , 1 - 40 months ) . Preoperative factors of patient age , sex , weight , body mass index , and medical comorbidity were similar between the 2 groups . Compared with LRYGB , patients who underwent LAGB experienced a greater incidence of late complications ( P reoperations ( P less weight loss ( P decreased overall satisfaction ( P LRYGB had a greater resolution of concomitant diabetes mellitus ( P sleep apnea ( P weight loss for LAGB recipients ranged from 1 to 15 manipulations . Our single mortality was in the LAGB group . CONCLUSIONS In super morbidly obese patients , LAGB is significantly associated with more late complications , reoperations , less weight loss , less reduction of medical comorbidity , and patient dissatisfaction compared with LRYGB . Further evaluation of LAGB in this patient population appears warranted",
"Background Obesity has recently been cited as the number one killer in the USA . This problem is both a national and regional epidemic . The health care costs of obesity and obesity-related illnesses are ever increasing , and gastric bypass surgery is becoming a popular treatment strategy . Recently , reports describe not only surgical outcomes , but also quality of life outcomes . The bigger issue of obesity-related illness resolution is still evolving . Our institution has performed well over 500 gastric bypasses since 2002 . We evaluated over 100 patients prior to and 1 year after gastric bypass surgery . Methods A prospect i ve study was design ed in order to systematic ally examine quality of life in gastric bypass patients and couple the results with both objective and subjective assessment of bariatric surgery outcomes . One hundred nineteen patients undergoing gastric bypass at our institution from January 2005 to December of 2005 were enrolled in the study . In addition to routine preprocedural and postprocedural follow-up , completion of quality of life forms and anthropometric measurements were performed . Using these data , we then correlated the change in quality of life scores with social factors , weight loss success , and status of obesity-related conditions . We also examined the impact of alcohol intake and other demographic factors on both quality of life and obesity related conditions . Results A total of 119 patients were enrolled in the study during the calendar year 2005 . Follow-up at approximately 1 year ( average 12.86 months ) postsurgery was obtained in 75 patients . A significant reduction in weight ( 144.4 ± 34.4 vs. 91.5 ± 28.8 ; p ) , body mass index ( 52.4 ± 12.2 vs. 32.3 ± 8.6 ; p ( 140.4 ± 14.7 vs. 130.0 ± 21.7 ; p 0.001 ) , and lipids ( 194.3 ± 33.8 vs. 165.7 ± 32.1 ; p 0.0001 ) was noted . Quality of life scores 1 year after gastric bypass surgery were also significantly improved ( 35.9 ± 19.5 vs. 82.2 ± 23.5 ; p usage of medications for obesity related conditions . Various measures of success ( change in BMI , change in quality of life scores , and follow up health ranking ) were compared across demographic and social factors and no significant associations were identified . Conclusions Gastric bypass is associated with a reduction in weight , BMI , mean systolic blood pressure , cholesterol , and the usage of medications for obesity-related conditions . A significant improvement in quality of life was also noted 1 year after surgery",
"BACKGROUND Obesity is associated with increased mortality . Weight loss improves cardiovascular risk factors , but no prospect i ve interventional studies have reported whether weight loss decreases overall mortality . In fact , many observational studies suggest that weight reduction is associated with increased mortality . METHODS The prospect i ve , controlled Swedish Obese Subjects study involved 4047 obese subjects . Of these subjects , 2010 underwent bariatric surgery ( surgery group ) and 2037 received conventional treatment ( matched control group ) . We report on overall mortality during an average of 10.9 years of follow-up . At the time of the analysis ( November 1 , 2005 ) , vital status was known for all but three subjects ( follow-up rate , 99.9 % ) . RESULTS The average weight change in control subjects was less than + /-2 % during the period of up to 15 years during which weights were recorded . Maximum weight losses in the surgical subgroups were observed after 1 to 2 years : gastric bypass , 32 % ; vertical-b and ed gastroplasty , 25 % ; and b and ing , 20 % . After 10 years , the weight losses from baseline were stabilized at 25 % , 16 % , and 14 % , respectively . There were 129 deaths in the control group and 101 deaths in the surgery group . The unadjusted overall hazard ratio was 0.76 in the surgery group ( P=0.04 ) , as compared with the control group , and the hazard ratio adjusted for sex , age , and risk factors was 0.71 ( P=0.01 ) . The most common causes of death were myocardial infa rct ion ( control group , 25 subjects ; surgery group , 13 subjects ) and cancer ( control group , 47 ; surgery group , 29 ) . CONCLUSIONS Bariatric surgery for severe obesity is associated with long-term weight loss and decreased overall mortality",
"The Program on the Surgical Control of the Hyperlipidemias ( POSCH ) was a secondary atherosclerosis intervention trial employing partial ileal bypass surgery as the intervention modality . For this report , we analyzed 105 subgroups in 35 variables in POSCH , chosen predominantly for their potential relationship to the risk of atherosclerotic coronary heart disease ( ACHD ) . We defined potential differential effects as those with : ( 1 ) an absolute z-value > or = 2.0 for the subgroup , if the absolute z-value for the overall effect was or = 3.0 for the subgroup and a relative risk or = 2.0 . For each of three major POSCH endpoints of overall mortality , ACHD mortality and ACHD mortality or confirmed nonfatal myocardial infa rct ion , we found seven subgroups with a differential risk reduction in the surgery group as compared to the control group . Allowing for identical subgroups for more than one endpoint , there were 13 individual subgroups with differential effects . Of these , seven demonstrated internal consistency across endpoints , and five of these seven displaced external consistency with known ACHD risk factors and for biological plausibility : triglyceride concentration > or = 200 mg/dl ; cigarette smoking ; overt or borderline diabetes mellitus ; a Minnesota ECG Q-QS code of 1 - 1 ; and obesity . A greater risk reduction , in comparison to the overall treatment effect , by the reduction of a single risk factor , hypercholesterolemia , in patients with at least two major ACHD risk factors was a provocative and an hypothesis-generating outcome of this analysis . The clinical implication s of this finding may lead to more aggressive cholesterol intervention in patients with multiple ACHD risk factors",
"Background : Obesity is now one of our major public health problems . Effective and acceptable treatment options are needed . The Lap-B and ® system is placed laparoscopically and allows adjustment of the level of gastric restriction . Methods : A prospect i ve study of 709 severely obese patients was conducted over a 6-year period at a university-based multidisciplinary referral center . After extensive preoperative evaluation , patients with a body mass index > 35 were treated by LapB and ® placement . Close follow-up with progressive adjustment of gastric restriction continued permanently . Medical co-morbidities were monitored as part of comprehensive prospect i ve data collection . Results : There have been no deaths perioperatively or during follow-up . Significant perioperative adverse events occurred in 1.2 % only . Reoperation has been needed for prolapse ( slippage ) in 12.5 % , erosion of the b and into the stomach in 2.8 % and for tubing breaks in 3.6 % . A steady progression of weight loss has occurred through the duration of the study with 52 ± 19 % EWL at 24 months ( n=333 ) , 53±22 % EWL at 36 months ( n=264 ) , 52 ± 24 % EWL at 48 months ( n=108 ) , 54 ± 24 % EWL at 60 months ( n=30 ) , and 57 ± 15 % EWL at 72 months ( n=10 ) . Major improvements have occurred in diabetes , asthma , gastroesophageal reflux , dyslipidemia , sleep apnea and depression . Quality of life as measured by R and SF-36 shows highly significant improvement . Conclusions : Placement of the Lap-B and ® system provides safe and effective control of severe obesity . The effect on weight loss is durable and is associated with major improvement in health and quality of life . It has the potential to provide a broadly acceptable option for this common and serious disease",
"AIMS To evaluate the effect of weight loss after bariatric surgery ( BS ) on peripheral adipocytokines , renal parameters and other cardiovascular risk factors ( CVRFs ) . METHODS A total of 70 ( 41 women ) extremely obese adults were prospect ively studied before and 12 months after surgery . CONTROLS 24 ( 15 women ) normal-weight adults . Anthropometric , biochemical and renal parameters were recorded . RESULTS Presurgery , adiponectin ( ADPN ) was lower , whereas leptin , insulin resistance , C-reactive protein , creatinine clearance and albuminuria were higher in patients than controls ( P Changes in ADPN correlated negatively with leptin , insulin resistance , albumin , C-reactive protein , and creatinine clearance . Multiple regression analysis : using changes in ADPN as the dependent variable , only changes in insulin resistance ( P=0.005 ) and albumin ( P=0.019 ) were significant independent determinants for changes in ADPN . No statistical differences were found in relation to the degree of obesity . CONCLUSION Patients changed to obesity type I after surgery . This implies a substantial improvement of CVRFs including ADPN , creatinine clearance and albuminuria . Changes in plasma ADPN correlated negatively with insulin resistance and with albuminemia but not with renal parameters . The lack of differences between different degrees of obesity suggests that the relationship between weight and CVRFs no longer exists when obesity becomes very extreme",
"Background : Open or laparoscopic Roux-en-Y gastric bypass ( RYGBP ) is the most common operation for treatment of morbid obesity in USA . The laparoscopic adjustable gastric b and ( LAGB ) has been the most common bariatric operation performed worldwide . The LapB and ® was approved for use in USA in July 2001 . Since then , several US surgeons have adopted one procedure preferentially over the other , and several have reported patient outcomes . We added the option of the LAGB to the RYGBP in our practice in July 2001 . We hypothesized that both procedures will provide similar weight loss and co-morbidity reduction if followed for a sufficient length of time . To enhance weight loss , we adopted a patient behavioral program that is easy to remember , in an attempt to ensure a reduction in caloric intake and reduce hunger regardless of the operation performed . Methods : A case-controlled matched-pair cohort study was conducted . All patients who presented to the Surgical Weight Control Center of Las Vegas between Aug 2001 and Aug 2004 for LAGB were placed into one group , and a matched-pair RYGBP cohort group was created . Patients in the RYGBP cohort were matched for age , sex , date of surgery , and BMI . All patients were evaluated on an intention to treat basis . Data were collected prospect ively and analyzed retrospectively . All patients were subjected to the same preoperative education regarding calorie reduction behaviors and diet change , and received the same postoperative counseling regarding long-term eating behavior and food choices . Results : During this period , 208 patients underwent LAGB and 600 underwent RYGBP . Of the 208 LAGB patients , 181 had suitable open or laparoscopic RYGBP matches . The two groups were similar in terms of age , sex , BMI , and co-morbidities . There were no deaths in either group . Resolution of co-morbidities statistically favored RYGBP as did the weight loss , over the study period . Conclusion : When patients are matched with 3-year follow-up according to time of surgery , age , sex and BMI , LRYGBP provides superior weight and co-morbidity reduction and can be done without severe complications . However , the LAGB is an effective weight loss tool and not every patient wishes to have the LRYGBP",
"BACKGROUND Super-obese patients can achieve adequate weight loss with long limb Roux-en-Y gastric bypass ( RYGB ) . These patients , however , might need longer intestinal limbs to control co-morbidities such as type 2 diabetes , lipid disorders , hypertension , sleep apnea , and gastroesophageal reflux disorder . METHODS A total of 105 patients with a body mass index of > or = 50 kg/m(2 ) were r and omly divided into 2 similar groups regarding sex , age , and number of co-morbidities . All underwent laparoscopic Roux-en-Y gastric bypass . In group 1 , the length of the biliary limb was 50 cm and the length of the Roux limb was 150 cm . In group 2 , the length of the biliary limb was 100 cm and the length of the Roux limb was 250 cm . RESULTS The follow-up for both group was 48 months . Diabetes was controlled in 58 % of group 1 and in 93 % of group 2 ( P Lipid disorders improved in 57 % of group 1 and in 70 % of group 2 ( P hypertension , sleep apnea , or gastroesophageal reflux disorder . The excess weight loss was faster in group 1 but was similar in both groups at 48 months ( 70 % in group 1 and 74 % in group 2 ) , with no statistical difference . CONCLUSION Patients with longer biliary and Roux limbs achieved greater type 2 diabetes control , greater lipid disorder improvement , and showed a trend toward faster excess weight loss",
"Objective : To analyze long-term weight loss , changes in comorbidities and quality of life , and late complications after laparoscopic and open gastric bypass . Summary Background Data : Early results from our prospect i ve r and omized trial comparing the outcome of laparoscopic versus open gastric bypass demonstrated less postoperative pain , shorter length of hospital stay , fewer wound-related complications , and faster convalescence for patients who underwent laparoscopic gastric bypass . Methods : Between May 1999 and March 2001 , 155 morbidly obese patients were enrolled in this prospect i ve trial , in which 79 patients were r and omized to laparoscopic gastric bypass and 76 to open gastric bypass . Two patients in the laparoscopic group required conversion to open surgery ; their data were analyzed within the laparoscopic group on an intention-to-treat basis . The 2 groups were well matched for body mass index , age , and gender . Outcome evaluation included weight loss , changes in comorbidities and quality of life , and late complications . Results : The mean follow-up was 39 ± 8 months . There were no significant differences in the percent of excess body weight loss between the 2 groups at the 3-year follow-up ( 77 % for laparoscopic versus 67 % for open ) . The rate of improvement or resolution of comorbidities was similar between groups . Improvement in quality of life , measured by the Moorehead-Ardelt Quality of Life Question naire , was observed in both groups without significant differences between groups . Late complications were similar between groups except for the rate of incisional hernia , which was significantly greater after open gastric bypass ( 39 % versus 5 % , P the rate of cholecystectomy , which was greater after laparoscopic gastric bypass ( 28 % versus 5 % , P = 0.03 ) . Conclusions : In this r and omized trial with a 3-year follow-up , we found that laparoscopic gastric bypass was equally effective as open gastric bypass with respect to weight loss and improvement in comorbidities and quality of life . A major advantage at long-term follow-up for patients who underwent laparoscopic gastric bypass was the reduction in the rate of incisional hernia",
"Background : Severe obesity is associated with type 2 diabetes and hypertension . Improvement in these comorbidities after surgically-induced weight loss has been documented , and laparoscopic adjustable gastric b and ing ( LAGB ) is an effective weight loss operation . Methods : Of 840 patients who underwent Lap-B and ® , data are available in 402 out of 413 patients whose surgery took place at ≥ 1 year ago . Preoperative and follow-up data were studied retrospectively to examine the effect of Lap-B and ® -induced weight loss on diabetes and hypertension . Results : Of 413 patients with at least 1 year postoperative follow-up , 53 ( 12.8 % ) were taking medications for type 2 diabetes preoperatively and 189 ( 45.7 % ) were on antihypertensive medications . 66 % ( n=35 ) of diabetic patients were also hypertensive . Resolution of diabetes was observed in 66 % at 1-year and 80 % at 2-year follow-up . HbA1c dropped from 7.25 % ( 5.6 - 11.0 , n=53 ) preoperatively to 5.58 % ( 5.0 - 6.2 , n=15 ) at 2 years after surgery . Hypertension resolved in 59.8 % and 74 % at 1 and 2 years , respectively . Percent excess weight loss ( % EWL ) was lower for diabetic patients than for our cohort population ( 39.2 % vs 41.2 % at 1 year , 46.7 % vs 54.2 % at 18 months , and 52.6 % vs 63.3 % at 2 years , respectively ) . Patients in whom diabetes was improved but not resolved had lower % EWL than did those whose diabetes went into remission ( 27.0 % at 1 year and 26.5 % at 2 years ) . Patients with the shortest duration of diabetes ( better weight loss after surgery achieved higher resolution rates . Conclusions : Dramatic improvement in – and frequent resolution of – diabetes and hypertension have been observed as a result of weight loss after Lap-B and ® surgery",
"BACKGROUND AND METHODS The Program on the Surgical Control of the Hyperlipidemias ( POSCH ) , a r and omized clinical trial , was design ed to test whether cholesterol lowering induced by the partial ileal bypass operation would favorably affect overall mortality or mortality due to coronary heart disease . The study population consisted of 838 patients ( 417 in the control group and 421 in the surgery group ) , both men ( 90.7 percent ) and women , with an average age of 51 years , who had survived a first myocardial infa rct ion . The mean follow-up period was 9.7 years . RESULTS When compared with the control group at five years , the surgery group had a total plasma cholesterol level 23.3 percent lower ( 4.71 + /- 0.91 vs. 6.14 + /- 0.89 mmol per liter [ mean + /- SD ] ; P less than 0.0001 ) , a low-density lipoprotein cholesterol level 37.7 percent lower ( 2.68 + /- 0.78 vs. 4.30 + /- 0.89 mmol per liter ; P less than 0.0001 ) , and a high-density lipoprotein cholesterol level 4.3 percent higher ( 1.08 + /- 0.26 vs. 1.04 + /- 0.25 mmol per liter ; P = 0.02 ) . Overall mortality and mortality due to coronary heart disease were reduced , but not significantly so ( deaths overall [ control vs. surgery ] , 62 vs. 49 , P = 0.164 ; deaths due to coronary disease , 44 vs. 32 , P = 0.113 ) . The overall mortality in the surgery subgroup with an ejection fraction greater than or equal to 50 percent was 36 percent lower ( control vs. surgery , 39 vs. 24 ; P = 0.021 ) . The value for two end points combined -- death due to coronary heart disease and confirmed nonfatal myocardial infa rct ion -- was 35 percent lower in the surgery group ( 125 vs. 82 events ; P less than 0.001 ) . During follow-up , 137 control-group and 52 surgery-group patients underwent coronary-artery bypass grafting ( P less than 0.0001 ) . A comparison of base-line coronary arteriograms with those obtained at 3 , 5 , 7 , and 10 years consistently showed less disease progression in the surgery group ( P less than 0.001 ) . The most common side effect of partial ileal bypass was diarrhea ; others included occasional kidney stones , gallstones , and intestinal obstruction . CONCLUSIONS Partial ileal bypass produces sustained improvement in the blood lipid patterns of patients who have had a myocardial infa rct ion and reduces their subsequent morbidity due to coronary heart disease . The role of this procedure in the management of hypercholesterolemia remains to be determined . These results provide strong evidence supporting the beneficial effects of lipid modification in the reduction of atherosclerosis progression",
"Background Bariatric surgery is being conducted more often for morbid obesity , but little evidence exists about how it affects the risk of future cardiovascular events . The goal of this study was to quantify the change in predicted 10-year cardiovascular risk following laparoscopic Roux-en-Y gastric bypass ( LRYGBP ) . Methods We conducted a prospect i ve clinical study of morbidly obese adults undergoing LRYGBP at a university hospital in the USA . Our primary outcome measure was mean change in 10-year cardiovascular risk at 12 months . We estimated cardiovascular risk by using the Framingham risk equation , which calculates the absolute risk of cardiovascular events for patients with no known history of heart disease , stroke , or peripheral vascular disease by using information on age , sex , blood pressure , total and high-density lipoprotein cholesterol levels , smoking status , and history of diabetes . Results Ninety-two participants underwent LRYGBP between December 2004 and October 2005 . Their predicted baseline 10-year cardiovascular risk was 6.7 % . At 6 and 12 months , their predicted risk had decreased to 5.2 % and 5.4 % , respectively . Assuming no change in risk among untreated patients , this represents an absolute risk reduction of 1.3 % ; which suggests that 77 morbidly obese patients would have to undergo LRYGBP to avert one new case of cardiovascular disease over the ensuing 10 years ( number needed to treat = 77 ) . Conclusion Our findings indicate that LRYGBP is associated with improvements in cardiovascular risk factors and a corresponding decrease in predicted 10-year risk of cardiovascular disease",
"The aim of this study was to examine the effect of surgical weight reduction on cardiac structure and function and to seek the determinants of these changes . Sixty-six severely obese adults ( BMI > or=35 kg/m(2 ) ) who received bariatric surgery underwent echocardiographic examination before and 3 months after surgery . At 3 months after surgery , BMI and systolic blood pressure ( BP ) decreased ( 43.3 + /- 6.3 to 34.1 + /- 5.6 kg/m(2 ) , P relative wall thickness ( RWT ) and LV mass index decreased significantly ( 0.43 + /- 0.05 to 0.35 + /- 0.05 , P change in systolic BP to be an independent predictor for the changes in RWT and LV mass index . In myocardial performance , peak systolic mitral annular velocity and all diastolic indexes showed significant improvements . We concluded that LV hypertrophy and function improved rapidly after bariatric surgery in severely obese adults . BP reduction was the major determinant for the regression of LV hypertrophy in the early stage of surgical weight reduction",
"BACKGROUND In 1990 , when the Program on the Surgical Control of the Hyperlipidemias ( POSCH ) reported its in-trial results strongly supporting the conclusion that effective lipid modification reduces progression of atherosclerosis , the differences for the end points of overall mortality and mortality from atherosclerotic coronary heart disease ( ACHD ) did not reach statistical significance . METHODS The Program on the Surgical Control of the Hyperlipidemias recruited men and women with a single documented myocardial infa rct ion between the ages of 30 and 64 years who had a plasma cholesterol level higher than 5.69 mmol/L ( 220 mg/dL ) or higher than 5.17 mmol/L ( 200 mg/dL ) if the low-density lipoprotein cholesterol level was in excess of 3.62 mmol/L ( 140 mg/dL ) . Between 1975 and 1983 , 838 patients were r and omized : 417 to the diet control group and 421 to the diet plus partial ileal bypass intervention group . Mean patient follow-up for this 5-year posttrial report was 14.7 years ( range , 12.2 - 20 years ) . RESULTS At 5 years after the trial , statistical significance was obtained for differences in overall mortality ( P = .049 ) and mortality from ACHD ( P = .03 ) . Other POSCH end points included overall mortality ( left ventricular ejection fraction > or = 50 % ) ( P = .01 ) , mortality from ACHD ( left ventricular ejection fraction > or = 50 % ) ( P = .05 ) , mortality from ACHD and confirmed nonfatal myocardial infa rct ion ( P confirmed nonfatal myocardial infa rct ion ( P mortality from ACHD , confirmed and suspected myocardial infa rct ion and unstable angina ( P incidence of coronary artery bypass grafting or percutaneous transluminal coronary angioplasty ( P onset of clinical peripheral vascular disease ( P = .02 ) . There were no statistically significant differences between groups for cerebrovascular events , mortality from non-ACHD , and cancer . All POSCH patients have been available for follow-up . CONCLUSION At 5 years after the trial , all POSCH mortality and atherosclerosis end points , including overall mortality and mortality from ACHD , demonstrated statistically significant differences between the study groups",
"BACKGROUND Obesity and its related comorbid illnesses have become a national health priority . We report comorbidity and quality of life ( QoL ) data after weight loss with gastric b and ing using the Swedish Adjustable Gastric B and ( SAGB ) . METHODS Data were collected prospect ively for 838 consecutive morbidly obese patients who underwent laparoscopic adjustable gastric b and ing ( LAGB ) between January 2001 and July 2007 . Patients were followed-up by a multidisciplinary team consisting of a surgeon , physician , dietician , and exercise consultant , all of whom were involved in the evaluation of clinical outcomes . Continuous data were reported as mean + /- SD ; categorical data were reported as number and percentage . Patients served as their own controls . RESULTS Respective preoperative mean age , weight , and body mass index ( BMI ) were 44 years ( range 16 - 76 ) , 122 kg ( range 86 - 240 ) , and 44 kg/m2 ( range 35 - 86 ) , respectively . SAGB implantation was accomplished by the pars flaccida technique with no conversion to an open procedure . Mature follow-up data were available for 35 % of patients at 24 months and 21 % at 36 months . In the total cohort of 838 patients , BMI ( mean + /- SD ) decreased to 32 + /- 5 kg/m2 and 32 + /- 7 kg/m2 at 24 months and 36 months , respectively . Percentage excess weight loss ( % EWL ) ( mean + /- SD ) was 32 % + /- 14 % ( n = 506 ) , 47 % + /- 15 % ( n = 461 ) , 52 % + /- 16 % ( n = 291 ) , and 54 % + /- 23 % ( n = 175 ) at 6 , 12 , 24 , and 36 months , respectively ( P 545 patients identified with comorbid illness at > 6-month follow-up . After a median follow-up of 13 months ( range 6 - 36 months ) , resolution and /or improvement of comorbidities was as follows : type 2 diabetes mellitus , 79 % ; metabolic syndrome , 78 % ; hypertension , 67 % ; dyslipidemia , 66 % ; gastroesophageal reflux , 66 % ; asthma , 57 % ; arthritis/joint pain , 70 % ; polycystic ovarian syndrome , 48 % ; and depression , 57 % . There was a significant improvement in QoL ( as measured by the Short Form-36 Health Survey [ SF-36 ] ) , bringing patients ' QoL to a level consistent with that of community norms in all 8 domain scores . Of 342 patients surveyed with the Beck Depression Inventory ( BDI-II ) , a statistically significant improvement in depressive mood was also observed ( P SAGB provides a dramatic reduction in many serious comorbid illnesses as well as improvement in the psychosocial wellbeing of morbidly obese patients",
"BACKGROUND Weight loss is associated with short-term amelioration and prevention of metabolic and cardiovascular risk , but whether these benefits persist over time is unknown . METHODS The prospect i ve , controlled Swedish Obese Subjects Study involved obese subjects who underwent gastric surgery and contemporaneously matched , conventionally treated obese control subjects . We now report follow-up data for subjects ( mean age , 48 years ; mean body-mass index , 41 ) who had been enrolled for at least 2 years ( 4047 subjects ) or 10 years ( 1703 subjects ) before the analysis ( January 1 , 2004 ) . The follow-up rate for laboratory examinations was 86.6 percent at 2 years and 74.5 percent at 10 years . RESULTS After two years , the weight had increased by 0.1 percent in the control group and had decreased by 23.4 percent in the surgery group ( P weight had increased by 1.6 percent and decreased by 16.1 percent , respectively ( P Energy intake was lower and the proportion of physically active subjects higher in the surgery group than in the control group throughout the observation period . Two- and 10-year rates of recovery from diabetes , hypertriglyceridemia , low levels of high-density lipoprotein cholesterol , hypertension , and hyperuricemia were more favorable in the surgery group than in the control group , whereas recovery from hypercholesterolemia did not differ between the groups . The surgery group had lower 2- and 10-year incidence rates of diabetes , hypertriglyceridemia , and hyperuricemia than the control group ; differences between the groups in the incidence of hypercholesterolemia and hypertension were undetectable . CONCLUSIONS As compared with conventional therapy , bariatric surgery appears to be a viable option for the treatment of severe obesity , result ing in long-term weight loss , improved lifestyle , and , except for hypercholesterolemia , amelioration in risk factors that were elevated at baseline",
"Background : Morbid obesity has been described as a continuing epidemic affecting a growing portion of our population . We report an outcome analysis of our early experience with laparoscopic Roux-en-Y gastric bypass ( LRYGB ) in the treatment of morbid obesity . Methods : Two surgeons performed 116 consecutive LRYGBs at a single institution , creating a 25-ml pouch and a 90- to 150-cm Roux limb . The prospect ively collected data included patient demographics , comorbidities , postoperative weight loss , and complications . Results : All eight conversions to an open procedure occurred early during the experience of the surgeons . The mean operating room time for the first 50 cases was 272 min , which decreased to 198 min with experience . The mean length of hospital stay was 3 days . There were 34 complications in 27 patients ( 23.3 % ) , 14 of which ( 12 % ) required reoperation . At 18 months postoperatively , the patients had lost 77 % of their excess weight , and their body mass index had decreased from a mean of 49.3 to 32.6 kg/m2 . As a result of LRYGB , 25 % of the patients were rendered completely free of any pharmacologic treatment for their preexisting comorbidities . Conclusions : Although technically challenging , LRYGB can be performed safely with excellent long-term results . The mean operating room time and conversion rate improved with experience . As this study showed , LRYGB achieves an excellent rate of weight loss and improvement in preoperative comorbidities with a minimal length of hospital stay and an acceptable complication rate"
] | 41162d74-06ff-11f0-808a-c43d1ab1c353 |
Background Accelerometers are widely used to measure sedentary time , physical activity , physical activity energy expenditure ( PAEE ) , and sleep-related behaviors , with the ActiGraph being the most frequently used br and by research ers . However , data collection and processing criteria have evolved in a myriad of ways out of the need to answer unique research questions ; as a result there is no consensus . Objectives The purpose of this review was to : ( 1 ) compile and classify existing studies assessing sedentary time , physical activity , energy expenditure , or sleep using the ActiGraph GT3X/+ through data collection and processing criteria to improve data comparability and ( 2 ) review data collection and processing criteria when using GT3X/+ and provide age-specific practical considerations based on the validation/calibration studies identified . Methods Two independent research ers conducted the search in PubMed and Web of Science . We included all original studies in which the GT3X/+ was used in laboratory , controlled , or free-living conditions published from 1 January 2010 to the 31 December 2015 . Results The present systematic review provides key information about the following data collection and processing criteria : placement , sampling frequency , filter , epoch length , non-wear-time , what constitutes a valid day and a valid week , cut-points for sedentary time and physical activity intensity classification , and algorithms to estimate PAEE and sleep-related behaviors . The information is organized by age group , since criteria are usually age-specific . Conclusion This review will help research ers and practitioners to make better decisions before ( i.e. , device placement and sampling frequency ) and after ( i.e. , data processing criteria ) data collection using the GT3X/+ accelerometer , in order to obtain more valid and comparable data . PROSPERO registration numberCRD42016039991 | [
"Background Public health research on sedentary behavior ( SB ) in youth has heavily relied on accelerometers . However , it has been limited by the lack of consensus on the most accurate accelerometer cut-points as well as by unknown effects caused by accelerometer position ( wrist vs. hip ) and output ( single axis vs. multiple axes ) . The present study systematic ally evaluates classification accuracy of different Actigraph cut-points for classifying SB using hip and wrist-worn monitors and establishes new cut-points to enable use of the 3-dimensional vector magnitude data ( for both hip and wrist placement ) . Methods A total of 125 children ages 7–13 yrs performed 12 r and omly selected activities ( from a set of 24 different activities ) for 5 min each while wearing tri-axial Actigraph accelerometers on both the hip and wrist . The accelerometer data were categorized as either sedentary or non-sedentary minutes using six previously studied cut-points : 100counts-per-minute ( CPM ) , 200CPM , 300CPM , 500CPM , 800CPM and 1100CPM . Classification accuracy was evaluated with Cohen 's Kappa ( κ ) and new cut-points were identified from Receiver Operating Characteristic ( ROC ) . Results Of the six cut-points , the 100CPM value yielded the highest classification accuracy ( κ = 0.81 ) for hip placement . For wrist placement , all of the cut-points produced low classification accuracy ( ranges of κ from 0.44 to 0.67 ) . Optimal sedentary cut-points derived from ROC were 554.3CPM ( ROC-AUC of 0.99 ) for vector magnitude for hip , 1756CPM ( ROC-AUC of 0.94 ) for vertical axis for wrist , and 3958.3CPM ( ROC-AUC of 0.93 ) for vector magnitude for wrist placement . Conclusions The 100CPM was supported for use with vertical axis for hip placement , but not for wrist placement . The ROC-derived cut-points can be used to classify youth SB with the wrist and with vector magnitude data",
"This investigation developed models to estimate aspects of physical activity and sedentary behavior from three-axis high-frequency wrist-worn accelerometer data . The models were developed and tested on 20 participants ( n = 10 males , n = 10 females , mean age = 24.1 , mean body mass index = 23.9 ) , who wore an ActiGraph GT3X+ accelerometer on their dominant wrist and an ActiGraph GT3X on the hip while performing a variety of scripted activities . Energy expenditure was concurrently measured by a portable indirect calorimetry system . Those calibration data were then used to develop and assess both machine-learning and simpler models with fewer unknown parameters ( linear regression and decision trees ) to estimate metabolic equivalent scores ( METs ) and to classify activity intensity , sedentary time , and locomotion time . The wrist models , applied to 15-s windows , estimated METs [ r and om forest : root mean squared error ( rSME ) = 1.21 METs , hip : rMSE = 1.67 METs ] and activity intensity ( r and om forest : 75 % correct , hip : 60 % correct ) better than a previously developed model that used counts per minute measured at the hip . In a separate set of comparisons , the simpler decision trees classified activity intensity ( r and om forest : 75 % correct , tree : 74 % correct ) , sedentary time ( r and om forest : 96 % correct , decision tree : 97 % correct ) , and locomotion time ( r and om forest : 99 % correct , decision tree : 96 % correct ) nearly as well or better than the machine-learning approaches . Preliminary investigation of the models ' performance on two free-living people suggests that they may work well outside of controlled conditions",
"Background Accelerometers objective ly assess physical activity ( PA ) and are currently used in several large-scale epidemiological studies , but there is no consensus for processing the data . This study compared the impact of wear-time assessment methods and using either vertical (V)-axis or vector magnitude ( VM ) cut-points on accelerometer output . Methods Participants ( 7,650 women , mean age 71.4 y ) were mailed an accelerometer ( ActiGraph GT3X+ ) , instructed to wear it for 7 days , record date s and times the monitor was worn on a log , and return the monitor and log via mail . Data were processed using three wear-time methods ( logs , Troiano or Choi algorithms ) and V-axis or VM cut-points . Results Using algorithms alone result ed in \" mail-days \" incorrectly identified as \" wear-days \" ( 27 - 79 % of subjects had > 7-days of valid data ) . Using only date s from the log and the Choi algorithm yielded : 1 ) larger sample s with valid data than using log date s and times , 2 ) similar wear-times as using log date s and times , 3 ) more wear-time ( V , 48.1 min more ; VM , 29.5 min more ) than only log date s and Troiano algorithm . Wear-time algorithm impacted sedentary time ( ~30 - 60 min lower for Troiano vs. Choi ) but not moderate-to-vigorous ( MV ) PA time . Using V-axis cut-points yielded ~60 min more sedentary time and ~10 min less MVPA time than using VM cut-points . Conclusions Combining log- date s and the Choi algorithm was optimal , minimizing missing data and research er burden . Estimates of time in physical activity and sedentary behavior are not directly comparable between V-axis and VM cut-points . These findings will inform consensus development for accelerometer data processing in ongoing epidemiologic studies",
"OBJECTIVE To calibrate the Actigraph GT3X+ accelerometer for wrist-worn placement in young preschoolers by developing intensity thresholds for sedentary , low- and high-intensity physical activity . Furthermore , to cross-vali date the developed thresholds in young preschoolers . METHODS Actigraph GT3X+ was used to measure physical activity during structured activities and free play in 38 children ( 15 - 36 months ) . Activity was video recorded and scored into sedentary , low- and high-intensity physical activity based on Children 's Activity Rating Scale ( CARS ) and combined with accelerometer data using a 5 s epoch . Receiver operating characteristic analysis was used to develop intensity thresholds in 26 r and omly selected children . The remaining 12 children were used for cross-validation . RESULTS Intensity thresholds for sedentary were ≤89 vertical counts ( Y ) and ≤221 vector magnitude ( VM ) counts per 5 s and ≥440 Y counts and ≥730 VM counts per 5 s for high-intensity physical activity . Sensitivity and specificity were 60 - 100 % for the developed intensity thresholds . Strong correlations ( Spearman rank correlation 0.69 - 0.91 ) were found in the cross-validation sample between the developed thresholds for the accelerometer and CARS scoring time in all intensity categories . CONCLUSION The developed intensity thresholds appear valid to categorize sedentary behaviour and physical activity intensity categories in children 2 years of age",
"Objectives Evaluate the predictive validity of ActiGraph energy expenditure equations and the classification accuracy of physical activity intensity cut-points in preschoolers . Methods Forty children aged 4–6 years ( 5.3±1.0 years ) completed a ∼150-min room calorimeter protocol involving age-appropriate sedentary , light and moderate-to vigorous-intensity physical activities . Children wore an ActiGraph GT3X on the right mid-axillary line of the hip . Energy expenditure measured by room calorimetry and physical activity intensity classified using direct observation were the criterion methods . Energy expenditure was predicted using Pate and Puyau equations . Physical activity intensity was classified using Evenson , Sirard , Van Cauwenberghe , Pate , Puyau , and Reilly , ActiGraph cut-points . Results The Pate equation significantly overestimated VO2 during sedentary behaviors , light physical activities and total VO2 ( P No difference was found between measured and predicted VO2 during moderate-to vigorous-intensity physical activities ( P = 0.072 ) . The Puyau equation significantly underestimated activity energy expenditure during moderate-to vigorous-intensity physical activities , light-intensity physical activities and total activity energy expenditure ( P no overestimation of activity energy expenditure during sedentary behavior was found . The Evenson cut-point demonstrated significantly higher accuracy for classifying sedentary behaviors and light-intensity physical activities than others . Classification accuracy for moderate-to vigorous-intensity physical activities was significantly higher for Pate than others . Conclusion Available ActiGraph equations do not provide accurate estimates of energy expenditure across physical activity intensities in preschoolers . Cut-points of ≤25counts⋅15 s−1 and ≥420 counts⋅15 s−1 for classifying sedentary behaviors and moderate-to vigorous-intensity physical activities , respectively , are recommended",
"The triaxial GT3X+ accelerometer can measure activity counts in the vertical , horizontal right to left , horizontal front to back planes , and can generate a summative score of the three axes represented by vector magnitude ( VM ) . Information on the reliability of the GT3X+ at the hip , wrist and ankle sites , over all axes and VM during activities of daily living ( ADL ) is lacking in the literature . Forty healthy adults ( 14 men and 26 women ) were r and omly assigned to perform 10 of 20 ADL ( consisting of sedentary , housework , yard work , locomotive and recreational activities ) while wearing two monitors on the hip , wrist and ankle . Subjects performed each ADL over 7 min and the mean activity counts during the last 4 min were used for analyses . Average intraclass correlations between monitors were high for the three sites for each axis and VM ( hip : 0.943 , 0.857 , 0.864 and 0.966 , respectively ; wrist : 0.994 , 0.963 , 0.961 and 0.989 , respectively ; ankle : 0.977 , 0.979 , 0.927 and 0.986 , respectively ) . These data suggest that GT3X+ accelerometers measurements made from the hip , wrist and ankle sites are reliable during ADL across all axes and VM",
"Background Public health initiatives world-wide recommend increasing physical activity ( PA ) to improve health . However , the dose and the intensity of PA producing the most benefit are still debated . Accurate assessment of PA is necessary in order to 1 ) investigate the dose – response relationship between PA and health , 2 ) shape the most beneficial public health initiatives and 3 ) test the effectiveness of such initiatives . Actigraph accelerometer is widely used to objective ly assess PA , and the raw data is given in counts per unit time . Count-thresholds for low , moderate and vigorous PA are mostly based on absolute intensity . This leads to largely inadequate PA intensity assessment in a large proportion of the elderly , who due to their declining maximal oxygen uptake ( VO2max ) can not reach the moderate/vigorous intensity as defined in absolute terms . To resolve this issue , here we report relative Actigraph intensity-thresholds for the elderly . Methods Submaximal-oxygen-uptake , VO2max and maximal heart rate ( HRmax ) were measured in 111 70–77 year olds , while wearing an Actigraph-GT3X+ . Relationship between VO2max percentage ( % ) , counts-per-minute ( CPM ) and gender ( for both the vertical-axis ( VA ) and vector-magnitude ( VM ) ) and VO2max% and HRmax% was established using a mixed-regression-model . VM- and VA-models were tested against each other to see which model predicts intensity of PA better . Results VO2max and gender significantly affected number of CPM at different PA intensities ( p predictor of PA-intensity than VA-model ( p predicts customized relative intensity of PA ( either VO2max% or HRmax% ) using counts-per-minute values as input . Conclusion Intensity-thresholds depend on VO2max , gender and Actigraph-axis . PA intensity-thresholds that take all these factors into account allow for more accurate relative intensity PA assessment in the elderly and will be useful in future PA research .Trial registration ( Clinical Trials.gov Identifier : NCT02017847 , registered 17 . December 2013",
"Wrist accelerometers are being used in population level surveillance of physical activity ( PA ) but more research is needed to evaluate their validity for correctly classifying types of PA behavior and predicting energy expenditure ( EE ) . In this study we compare accelerometers worn on the wrist and hip , and the added value of heart rate ( HR ) data , for predicting PA type and EE using machine learning . Forty adults performed locomotion and household activities in a lab setting while wearing three ActiGraph GT3X+ accelerometers ( left hip , right hip , non-dominant wrist ) and a HR monitor ( Polar RS400 ) . Participants also wore a portable indirect calorimeter ( COSMED K4b2 ) , from which EE and metabolic equivalents ( METs ) were computed for each minute . We developed two predictive models : a r and om forest classifier to predict activity type and a r and om forest of regression trees to estimate METs . Predictions were evaluated using leave-one-user-out cross-validation . The hip accelerometer obtained an average accuracy of 92.3 % in predicting four activity types ( household , stairs , walking , running ) , while the wrist accelerometer obtained an average accuracy of 87.5 % . Across all 8 activities combined ( laundry , window washing , dusting , dishes , sweeping , stairs , walking , running ) , the hip and wrist accelerometers obtained average accuracies of 70.2 % and 80.2 % respectively . Predicting METs using the hip or wrist devices alone obtained root mean square errors ( rMSE ) of 1.09 and 1.00 METs per 6 min bout , respectively . Including HR data improved MET estimation , but did not significantly improve activity type classification . These results demonstrate the validity of r and om forest classification and regression forests for PA type and MET prediction using accelerometers . The wrist accelerometer proved more useful in predicting activities with significant arm movement , while the hip accelerometer was superior for predicting locomotion and estimating EE",
"BACKGROUND Atherosclerosis develops from early childhood ; physical activity could positively affect this process . This study 's aim was to assess the associations of objective ly measured physical activity with clustering of cardiovascular disease risk factors in children and derive guidelines on the basis of this analysis . METHODS We did a cross-sectional study of 1732 r and omly selected 9-year-old and 15-year-old school children from Denmark , Estonia , and Portugal . Risk factors included in the composite risk factor score ( mean of Z scores ) were systolic blood pressure , triglyceride , total cholesterol/HDL ratio , insulin resistance , sum of four skinfolds , and aerobic fitness . Individuals with a risk score above 1 SD of the composite variable were defined as being at risk . Physical activity was assessed by accelerometry . FINDINGS Odds ratios for having clustered risk for ascending quintiles of physical activity ( counts per min ; cpm ) were 3.29 ( 95 % CI 1.96 - 5.52 ) , 3.13 ( 1.87 - 5.25 ) , 2.51 ( 1.47 - 4.26 ) , and 2.03 ( 1.18 - 3.50 ) , respectively , compared with the most active quintile . The first to the third quintile of physical activity had a raised risk in all analyses . The mean time spent above 2000 cpm in the fourth quintile was 116 min per day in 9-year-old and 88 min per day in 15-year-old children . INTERPRETATION Physical activity levels should be higher than the current international guidelines of at least 1 h per day of physical activity of at least moderate intensity to prevent clustering of cardiovascular disease risk factors",
"Research into daily physical activity ( PA ) patterns of older adults ( ≥70 years ) has primarily relied on self-report . This study used accelerometry , an objective measure of minute-by-minute movement , to assess PA volume and intensity performed by older adults recruited to the Better Ageing project . Results were used to estimate the degree to which current health recommendations for PA were met . Participants [ 91 older females ( OF ) aged 76.0 ± 4.0 years ( mean ± SD ) , 70 older males ( OM ) 76.3 ± 3.9 years , 23 young females ( YF ) 26.8 ± 4.1 years and 22 young males ( YM ) 27.0 ± 4.2 years ] wore an MTI actigraph model 7164 recording activity in 1-min epochs for 7 days . Only those with at least 5 days , and 10 h of actigraph data per day , were included in the analysis , using Caloric . Bas ( CSA Inc. 1999 ) software and a tailored Microsoft Access 2000 macro . Mean counts min-1 day-1 were 37 % lower for older adults than for young adults [ OF 236.1 ± 84.4 vs. YF 370.0 ± 81.1 counts min-1 day-1t(114 ) = −6.86 , P in activity intensity range performing significantly fewer minutes of moderate to vigorous ( MV ) PA day-1 than young adults [ OF 16.7 ± 12.2 vs. YF 38.4 ± 18.4 MVPA min day-1 , t(114 ) = −6.90 , P any sustained 10-min MVPA bouts ( OF 48.4 % vs. YF 13.0 % , χ2 = 8.10 , P = 0.004 ; OM 44.3 % vs. YM 4.5 % , χ2 = 9.97 , P = 0.002 ) , and none met current PA recommendations for health . This study is the first to provide objective data on a large sample of adults aged 70 years and over and indicates low levels of daily movement that are likely to be inadequate for optimal health benefit",
"PURPOSE To derive a regression equation that estimates metabolic equivalent ( MET ) from accelerometer counts , and to define thresholds of accelerometer counts that can be used to delineate sedentary , light , moderate , and vigorous activity in adolescent girls . METHODS Seventy-four healthy 8th grade girls , age 13 - 14 yr , were recruited from urban areas of Baltimore , MD , Minneapolis/St . Paul , MN , and Columbia , SC , to participate in the study . Accelerometer and oxygen consumption (.-)VO(2 ) ) data for 10 activities that varied in intensity from sedentary ( e.g. , TV watching ) to vigorous ( e.g. , running ) were collected . While performing these activities , the girls wore two accelerometers , a heart rate monitor and a Cosmed K4b2 portable metabolic unit for measurement of (.-)VO(2 ) . A r and om-coefficients model was used to estimate the relationship between accelerometer counts and (.-)VO(2 ) . Activity thresholds were defined by minimizing the false positive and false negative classifications . RESULTS The activities provided a wide range in (.-)VO(2 ) ( 3 - 36 mL x kg x min ) with a correspondingly wide range in accelerometer counts ( 1- 3928 counts x 30 s ) . The regression line for MET score versus counts was MET = 2.01 + /- 0.00171 ( counts x 30 s ) ( mixed model R = 0.84 , SEE = 1.36 ) . A threshold of 1500 counts x 30 s defined the lower end of the moderate intensity ( approximately 4.6 METs ) range of physical activity . That cutpoint distinguished between slow and brisk walking , and gave the lowest number of false positive and false negative classifications . The threshold ranges for sedentary , light , moderate , and vigorous physical activity were found to be 0 - 50 , 51- 1499 , 1500 - 2600 , and > 2600 counts x 30 s , respectively . CONCLUSION The developed equation and these activity thresholds can be used for prediction of MET score from accelerometer counts and participation in various intensities of physical activity in adolescent girls",
"This paper determines if the leveling off ( ' plateau/inverted-U ' phenomenon ) of vertical ActiGraph activity counts during running at higher speeds is attributable to the monitor 's signal filtering and acceleration detection characteristics . Ten endurance-trained male participants ( mean ( SD ) age = 28.2 ( 4.7 ) years ) walked at 3 , 5 and 7 km h(-1 ) , and ran at 8 , 10 , 12 , 14 , 16 , 18 and 20 km h(-1 ) on a force treadmill while wearing an ActiGraph GT3X monitor at the waist . Triaxial accelerations of the body 's center of mass ( CoM ) and frequency content of these accelerations were computed from the force treadmill data . GT3X vertical activity counts demonstrated the expected ' plateau/inverted-U ' phenomenon . In contrast , vertical CoM accelerations increased with increasing speed ( 1.32 ± 0.26 g at 10 km h(-1 ) and 1.68 ± 0.24 g at 20 km h(-1 ) ) . The dominant frequency in the CoM acceleration signals increased with running speed ( 14.8 ± 3.2 Hz at 10 km h(-1 ) and 24.8 ± 3.2 Hz at 20 km h(-1 ) ) and lay beyond the ActiGraph b and -pass filter ( 0.25 to 2.5 Hz ) limits . In conclusion , CoM acceleration magnitudes during walking and running lie within the ActiGraph monitor 's dynamic acceleration detecting capability . Acceleration signals of higher frequencies that are eliminated by the ActiGraph b and -pass filter may be necessary to distinguish among exercise intensity at higher running speeds",
"OBJECTIVES To calibrate and vali date the ActiGraph GT3X+ to measure sedentary behaviour and physical activity in 2 - 3 year olds , using 5-s epochs ; and to compare the predictive validity of the result ing cut-points with that of NHANES ' , Trost 's , and Pate 's 15-s cut-points . DESIGN Cross-sectional study . METHODS Eighteen children ( 2.86 ± 0.60 years ) wore an ActiGraph GT3X+ during video-recorded semi-structured calibration activity sessions . Activity was coded following Children 's Activity Rating Scale . Receiver Operating Characteristic analysis was used to derive Axis1 and vector magnitude cut-points for sedentary behaviour and moderate-to-vigorous physical activity at 5-s epochs . Agreement with Children 's Activity Rating Scale was assessed with Cohen 's kappa , Lin 's concordance , and Bl and -Altman plots . Predictive validity of all cut-points was assessed in an independent sample of 20 children ( 2.99 ± 0.48 years ) video-recorded during free-play , using the same procedures as the calibration phase . RESULTS During calibration , vector magnitude cut-points ( sedentary behaviour ≤ 96.12 counts ; moderate-to-vigorous physical activity ≥ 361.94 counts ) showed slightly better classification agreement with Children 's Activity Rating Scale than Axis1 cut-points ( sedentary behaviour ≤ 5 counts ; moderate-to-vigorous physical activity ≥ 165 counts ) , but the latter showed the lowest bias in estimated sedentary behaviour and moderate-to-vigorous physical activity time . In the validation sample , 5-s Axis1 cut-points showed the best predictive validity and lowest mean differences of all cut-points between predicted and observed sedentary behaviour ( -2.31 % ) , light physical activity ( -24.40 % ) , and total physical activity time ( -0.95 % ) . Moderate-to-vigorous physical activity time was significantly overestimated by all cut-points ( 128.33 - 184.17 % ) . CONCLUSIONS Because moderate-to-vigorous physical activity was highly overestimated , using only the 5-s Axis1 sedentary behaviour cut-point to distinguish sedentary behaviour from total physical activity is advised . The high accuracy indicates that these cut-points are useful for epidemiological studies involving the sedentary behaviour and physical activity of 2 - 3 year olds",
"Purpose : Many ActiGraph accelerometer cutoff points and equations have been developed to classify children and youth 's physical activity ( PA ) into different intensity levels . Using a sample from the Chinese City Children and Youth Physical Activity Study , this study was to develop new ActiGraph cutoff points for moderate-to-vigorous physical activity ( MVPA ) and vigorous physical activity ( VPA ) for Chinese children and youth and to compare the classification accuracy to that of a set of existing cutoff points . Method : A total of 367 Chinese children and youth ( 179 boys , 188 girls , ages 9–17 years old ) had their resting metabolic rate measured and completed six 5-min treadmill walking/running tests ( tested at different speeds : 3 km·h− 1 , 4 km·h− 1 , 5 km·h− 1 , 6 km·h− 1 , 7 km·h− 1 , and 8 km·h− 1 ) , one unit of the 3rd broadcast gymnastics ( Version 3 , Xi-Wang-Feng-Fan and Wu-Dong-Qing-Chun ) , and 2 sets of table tennis exercises ( continuous attack and multiple balls ) . Participants wore 1 ActiGraph GT3X accelerometer on their right hip during each test , and their oxygen consumption and heart rate ( HR ) were measured using Cosmed K4b2 and Polar HR transmitter . The participants were r and omly divided into a calibration group ( n = 331 , 90 % ) and a cross-validation group ( n = 36 , 10 % ) . Using the receiver-operating characteristic curve , the data from the calibration group were used to determine the cutoff points for MVPA and VPA . Using the data from the cross-validation group , classification accuracy of different cutoff points was evaluated through kappa statistics , sensitivity , and specificity . Results : A set of new cutoff points of counts per minute ( CPM ) was generated using the calibration data , and these cutoff points were proven to be more accurate compared with those developed in previous studies . Conclusion : When using ActiGraph accelerometers to measure the Chinese children and youth 's PA , we recommended using the cutoff points of CPM ≥ 2,800 to define MVPA and CPM ≥ 4,000 for VPA",
"Background Following publication of the PRISMA statement , the UK Centre for Review s and Dissemination ( CRD ) at the University of York in Engl and began to develop an international prospect i ve register of systematic review s with health-related outcomes . The objectives were to reduce unplanned duplication of review s and provide transparency in the review process , with the aim of minimizing reporting bias . Methods An international advisory group was formed and a consultation undertaken to establish the key items necessary for inclusion in the register and to gather views on various aspects of functionality . This article describes the development of the register , now called PROSPERO , and the process of registration . Results PROSPERO offers free registration and free public access to a unique prospect i ve register of systematic review s across all areas of health from all around the world . The dedicated web-based interface is electronically search able and available to all prospect i ve registrants . At the moment , inclusion in PROSPERO is restricted to systematic review s of the effects of interventions and strategies to prevent , diagnose , treat , and monitor health conditions , for which there is a health-related outcome .Ideally , registration should take place before the research ers have started formal screening against inclusion criteria but review s are eligible as long as they have not progressed beyond the point of completing data extraction .The required data set captures the key attributes of review design as well as the administrative details necessary for registration .Su bmi tted registration forms are checked against the scope for inclusion in PROSPERO and for clarity of content before being made publicly available on the register , rejected , or returned to the applicant for clarification . The public records include an audit trail of major changes to planned methods , details of when the review has been completed , and links to result ing publications when provided by the authors . Conclusions There has been international support and an enthusiastic response to the principle of prospect i ve registration of protocol s for systematic review s and to the development of PROSPERO .In October 2011 , PROSPERO contained 200 records of systematic review s being undertaken in 26 countries around the world on a diverse range of interventions",
"The purpose of this study was to develop and vali date automatic scoring methods to distinguish sleep from wakefulness based on wrist activity . Forty-one subjects ( 18 normals and 23 with sleep or psychiatric disorders ) wore a wrist actigraph during overnight polysomnography . In a r and omly selected sub sample of 20 subjects , c and i date sleep/wake prediction algorithms were iteratively optimized against st and ard sleep/wake scores . The optimal algorithms obtained for various data collection epoch lengths were then prospect ively tested on the remaining 21 subjects . The final algorithms correctly distinguished sleep from wakefulness approximately 88 % of the time . Actigraphic sleep percentage and sleep latency estimates correlated 0.82 and 0.90 , respectively , with corresponding parameters scored from the polysomnogram ( p scoring of wrist activity provides valuable information about sleep and wakefulness that could be useful in both clinical and research applications",
"PURPOSE We established accelerometer count ranges for the Computer Science and Applications , Inc. ( CSA ) activity monitor corresponding to commonly employed MET categories . METHODS Data were obtained from 50 adults ( 25 males , 25 females ) during treadmill exercise at three different speeds ( 4.8 , 6.4 , and 9.7 km x h(-1 ) ) . RESULTS Activity counts and steady-state oxygen consumption were highly correlated ( r = 0.88 ) , and count ranges corresponding to light , moderate , hard , and very hard intensity levels were or = 9499 cnts x min(-1 ) , respectively . A model to predict energy expenditure from activity counts and body mass was developed using data from a r and om sample of 35 subjects ( r2 = 0.82 , SEE = 1.40 kcal x min(-1 ) ) . Cross validation with data from the remaining 15 subjects revealed no significant differences between actual and predicted energy expenditure at any treadmill speed ( SEE = 0.50 - 1.40 kcal x min(-1 ) ) . CONCLUSIONS These data provide a template on which patterns of activity can be classified into intensity levels using the CSA accelerometer",
"PURPOSE The purpose of this study was to evaluate the validity of the CSA activity monitor as a measure of children 's physical activity using energy expenditure ( EE ) as a criterion measure . METHODS Thirty subjects aged 10 to 14 performed three 5-min treadmill bouts at 3 , 4 , and 6 mph , respectively . While on the treadmill , subjects wore CSA ( WAM 7164 ) activity monitors on the right and left hips . VO2 was monitored continuously by an automated system . EE was determined by multiplying the average VO2 by the caloric equivalent of the mean respiratory exchange ratio . RESULTS Repeated measures ANOVA indicated that both CSA monitors were sensitive to changes in treadmill speed . Mean activity counts from each CSA unit were not significantly different and the intraclass reliability coefficient for the two CSA units across all speeds was 0.87 . Activity counts from both CSA units were strongly correlated with EE ( r = 0.86 and 0.87 , P EE prediction equation was developed from 20 r and omly selected subjects and cross-vali date d on the remaining 10 . The equation predicted mean EE within 0.01 kcal.min-1 . The correlation between actual and predicted values was 0.93 ( P SEE was 0.93 kcal.min-1 . CONCLUSION These data indicate that the CSA monitor is a valid and reliable tool for quantifying treadmill walking and running in children",
"PURPOSE Accelerometers are a valuable tool for objective measurement of physical activity ( PA ) . Wrist-worn devices may improve compliance over st and ard hip placement , but more research is needed to evaluate their validity for measuring PA in free-living setting s. Traditional cut-point methods for accelerometers can be inaccurate and need testing in free living with wrist-worn devices . In this study , we developed and tested the performance of machine learning ( ML ) algorithms for classifying PA types from both hip and wrist accelerometer data . METHODS Forty overweight or obese women ( mean age = 55.2 ± 15.3 yr ; BMI = 32.0 ± 3.7 ) wore two ActiGraph GT3X+ accelerometers ( right hip , nondominant wrist ; ActiGraph , Pensacola , FL ) for seven free-living days . Wearable cameras captured ground truth activity labels . A classifier consisting of a r and om forest and hidden Markov model classified the accelerometer data into four activities ( sitting , st and ing , walking/running , and riding in a vehicle ) . Free-living wrist and hip ML classifiers were compared with each other , with traditional accelerometer cut points , and with an algorithm developed in a laboratory setting . RESULTS The ML classifier obtained average values of 89.4 % and 84.6 % balanced accuracy over the four activities using the hip and wrist accelerometer , respectively . In our data set with average values of 28.4 min of walking or running per day , the ML classifier predicted average values of 28.5 and 24.5 min of walking or running using the hip and wrist accelerometer , respectively . Intensity-based cut points and the laboratory algorithm significantly underestimated walking minutes . CONCLUSIONS Our results demonstrate the superior performance of our PA-type classification algorithm , particularly in comparison with traditional cut points . Although the hip algorithm performed better , additional compliance achieved with wrist devices might justify using a slightly lower performing algorithm",
"Purpose : The purpose of this study was to develop and cross-vali date an equation based on ActiGraph accelerometer GT3X output to predict children and youth 's energy expenditure ( EE ) of physical activity ( PA ) . Method : Participants were 367 Chinese children and youth ( 179 boys and 188 girls , aged 9 to 17 years old ) who wore 1 ActiGraph GT3X accelerometer on their right hip during the following tests/activities : resting metabolic rate ( RMR ) , six 5-min treadmill walk/runs ( tested at different speeds : 3 km·h− 1 , 4 km·h− 1 , 5 km·h− 1 , 6 km·h− 1 , 7 km·h− 1 , and 8 km·h− 1 ) , 1 broadcast gymnastics , and 2 table-tennis exercises . Participants ' oxygen consumption was measured using Cosmed K4b2 . The participants were r and omly divided into a calibration group ( n = 331 , 90 % ) and a cross-validation group ( n = 36 , 10 % ) . The calibration group 's data were used to determine the relationship between EE and triaxial vector magnitude counts ( VM ) using the Pearson correlation and to derive the equation using a stepwise multiple regression . In the cross-validation group , differences between measured and predicted EE were evaluated using pairwise t tests . Results : VM activity counts had a moderately high correlation with EE ( r = .758 , p EE prediction equation was developed : EE ( kcal·min− 1 ) = 0.00083 × VM+0.073 × weight − 2.01 ( R 2 = .72 , SEE = 1.45 kcal·min− 1 ) . According to the cross-validation study results , this equation could predict the EE within the range of known accuracy ( i.e. , about 20 % error ) . Conclusions : An equation based on ActiGraph accelerometer VM activity counts was derived to predict EE of PA in Chinese children and youth within the range of known accuracy",
" To test the feasibility and validity of the ActiGraph GT3X accelerometer in measuring physical activity of rural Malawian toddlers",
"OBJECTIVE The aims of this study were to develop an equation to predict energy expenditure and to derive cut-points for moderate and vigorous physical activity intensity from the Actigraph accelerometer output in children aged 12 years . METHODS The children performed a series of activities ( lying , sitting , slow walking , fast walking , hopscotch and jogging ) while wearing an Actigraph and a portable metabolic unit . The sample was divided into a developmental and a validation group . R and om intercepts models were used to develop a prediction equation in the developmental group . The equation was assessed in the validation group by calculating limits of agreement ( actual minus predicted energy expenditure ) . Thresholds for moderate and vigorous activity were derived by refitting the energy expenditure model with VO2 as the outcome . RESULTS The developmental group comprised 163 children , while the validation group comprised 83 children . The equation , adjusted for age and gender , adequately predicted energy expenditure from accelerometer counts . Physical activity intensity cut-points were derived from resting VO2 . The lower threshold for moderate intensity ( four METs ) , adjusted for age and gender , was 3581 counts per minute . The lower threshold for vigorous activity ( six METs ) was 6130 counts per minute . CONCLUSION The prediction equation and the derived cut-points will help to better interpret the output of the Actigraph in children aged 12 years . The cut-point for moderate to vigorous physical activity is higher than that reported previously"
] | 41162db0-06ff-11f0-808a-c43d1ab1c353 |
ABSTRACT Background : Pairwise meta-analyses have shown beneficial effects of individual dietary approaches on blood pressure but their comparative effects have not been established . Objective : Therefore we performed a systematic review of different dietary intervention trials and estimated the aggregate blood pressure effects through network meta- analysis including hypertensive and pre-hypertensive patients . Design : PubMed , Cochrane CENTRAL , and Google Scholar were search ed until June 2017 . The inclusion criteria were defined as follows : i ) R and omized trial with a dietary approach ; ii ) hypertensive and pre-hypertensive adult patients ; and iii ) minimum intervention period of 12 weeks . In order to determine the pooled effect of each intervention relative to each of the other intervention for both diastolic and systolic blood pressure ( SBP and DBP ) , r and om effects network meta- analysis was performed . Results : A total of 67 trials comparing 13 dietary approaches ( DASH , low-fat , moderate-carbohydrate , high-protein , low-carbohydrate , Mediterranean , Palaeolithic , vegetarian , low-GI/GL , low-sodium , Nordic , Tibetan , and control ) enrolling 17,230 participants were included . In the network meta- analysis , the DASH , Mediterranean , low-carbohydrate , Palaeolithic , high-protein , low-glycaemic index , low-sodium , and low-fat dietary approaches were significantly more effective in reducing SBP ( −8.73 to −2.32 mmHg ) and DBP ( −4.85 to −1.27 mmHg ) compared to a control diet . According to the SUCRAs , the DASH diet was ranked the most effective dietary approach in reducing SBP ( 90 % ) and DBP ( 91 % ) , followed by the Palaeolithic , and the low-carbohydrate diet ( ranked 3rd for SBP ) or the Mediterranean diet ( ranked 3rd for DBP ) . For most comparisons , the credibility of evidence was rated very low to moderate , with the exception for the DASH vs. the low-fat dietary approach for which the quality of evidence was rated high . Conclusion : The present network meta- analysis suggests that the DASH dietary approach might be the most effective dietary measure to reduce blood pressure among hypertensive and pre-hypertensive patients based on high quality evidence | [
"OBJECTIVE To test whether a weight loss program promotes greater weight loss , glycemic control , and improved cardiovascular disease risk factors compared with control conditions and whether there is a differential response to higher versus lower carbohydrate intake . RESEARCH DESIGN AND METHODS This r and omized controlled trial at two university medical centers enrolled 227 overweight or obese adults with type 2 diabetes and assigned them to parallel in-person diet and exercise counseling , with prepackaged foods in a planned menu during the initial phase , or to usual care ( UC ; two weight loss counseling sessions and monthly contacts ) . RESULTS Relative weight loss was 7.4 % ( 95 % CI 5.7–9.2 % ) , 9.0 % ( 7.1–10.9 % ) , and 2.5 % ( 1.3–3.8 % ) for the lower fat , lower carbohydrate , and UC groups ( P . Glycemic control markers and triglyceride levels were lower in the intervention groups compared with UC group at 1 year ( fasting glucose 141 [ 95 % CI 133–149 ] vs. 159 [ 144–174 ] mg/dL , P = 0.023 ; hemoglobin A1c 6.9 % [ 6.6–7.1 % ] vs. 7.5 % [ 7.1–7.9 % ] or 52 [ 49–54 ] vs. 58 [ 54–63 ] mmol/mol , P = 0.001 ; triglycerides 148 [ 134–163 ] vs. 204 [ 173–234 ] mg/dL , P lower hemoglobin A1c ( 6.6 % [ 95 % CI 6.3–6.8 % ] vs. 7.2 % [ 6.8–7.5 % ] or 49 [ 45–51 ] vs. 55 [ 51–58 ] mmol/mol ) at 1 year ( P = 0.008 ) . CONCLUSIONS The weight loss program result ed in greater weight loss and improved glycemic control in type 2 diabetes",
"Aims /hypothesisThe study aim ed to compare the effects of a 2 year intervention with a low-fat diet ( LFD ) or a low-carbohydrate diet ( LCD ) , based on four group meetings to achieve compliance . Methods This was a prospect i ve r and omised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and r and omised by drawing ballots . Patients that did not speak Swedish could not be recruited . The primary outcomes in this non-blinded study were weight and HbA1c . Patients on the LFD aim ed for 55–60 energy per cent ( E% ) and those on LCD for 20 E% from carbohydrate . Results The mean BMI and HbA1c of the participants were 32.7 ± 5.4 kg/m2 and 57.0 ± 9.2 mmol/mol , respectively . No patients were lost to follow-up . Weight loss did not differ between groups and was maximal at 6 months : LFD −3.99 ± 4.1 kg ( n = 31 ) ; LCD −4.31 ± 3.6 kg ( n = 30 ) ; p 0.020 within groups , respectively ) . HbA1c fell in the LCD group only ( LCD at 6 months −4.8 ± 8.3 mmol/mol , p = 0.004 , at 12 months −2.2 ± 7.7 mmol/mol , p = 0.12 ; LFD at 6 months −0.9 ± 8.8 mmol/mol , p = 0.56 ) . At 6 months , HDL-cholesterol had increased with the LCD ( from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l , p = 0.018 ) while LDL-cholesterol did not differ between groups . Insulin doses were reduced in the LCD group ( 0 months , LCD 42 ± 65 E , LFD 39 ± 51 E ; 6 months , LCD 30 ± 47 E , LFD 38 ± 48 E ; p = 0.046 for between-group change ) . Conclusions /interpretationWeight changes did not differ between the diet groups , while insulin doses were reduced significantly more with the LCD at 6 months , when compliance was good . Thus , aim ing for 20 % of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative . Trial registration : Clinical Trials.gov NCT01005498 Funding : University Hospital of Linköping Research Funds , Linköping University , the County Council of Östergötl and , and the Diabetes Research Centre of Linköping",
"Context In 2003 , the authors reported that severely obese adults lost more weight and had better serum lipid patterns after 6 months of a low-carbohydrate diet rather than a conventional low-fat diet . Contribution After 1 year , these same patients still had more favorable triglyceride and high-density lipoprotein cholesterol levels on the low-carbohydrate diet than on the conventional diet . However , weight loss and the other metabolic parameters were similar in the 2 diet groups . Caution s The effect of the modest improvements in high-density lipoprotein cholesterol and triglyceride levels on the development of diabetes and cardiovascular disease is unknown . The Editors The prevalence of obesity and its associated metabolic abnormalities has increased markedly over the past 2 decades ( 1 , 2 ) . Although guidelines to follow a highcomplex carbohydrate , low-fat , energy-deficient diet to achieve weight loss are generally accepted ( 3 ) , considerable public interest has focused on low-carbohydrate diets ( 4 ) . We recently reported that persons with severe obesity lost more weight and had greater improvements in triglyceride levels , insulin sensitivity , and glycemic control after 6 months of a low-carbohydrate diet as compared with a conventional weight loss diet based on calorie and fat restriction ( 5 ) . However , these findings were preliminary because of the short duration of that study ( 6 ) . A simultaneously published study by Foster and colleagues suggested that persons on a low-carbohydrate diet tended to regain weight by 1 year ( 7 ) . These findings were limited , however , because few participants completed the study and because the study used a self-help approach , which is less effective than direct counseling for maintaining weight loss ( 8) . Foster and colleagues also excluded persons with diabetes , which is highly prevalent in the obese population . During the development of this study , we decided to analyze and report preliminary results at 6 months and final results at 1 year . We thought that the short-term results would be important , given the high-risk nature of our study sample , but that long-term outcomes would provide more information about the sustainability of any diet-related outcomes . We now report our findings 1 year after r and omization to a low-carbohydrate diet versus a low-fat weight loss diet ( conventional diet ) in severely obese adults with a high prevalence of diabetes or the metabolic syndrome . Methods Study Participants The study design has been previously described ( 5 ) . Participants were recruited from the outpatient practice s of the Philadelphia Veterans Affairs Medical Center and included persons 18 years of age and older with a body mass index ( BMI ) of 35 kg/m2 or greater . The exclusion criteria were a serum creatinine level greater than 133 mol/L ( > 1.5 mg/dL ) , hepatic disease , severe life-limiting medical illness , inability to self-monitor glucose levels , or active use of a weight loss program or weight loss medication . Between May 2001 and November 2001 , 132 persons were r and omly assigned to either a low-carbohydrate diet ( n = 64 ) or a conventional diet ( n = 68 ) . The Institutional Review Committee at the Philadelphia Veterans Affairs Medical Center approved the study , and all participants provided written informed consent . Interventions Diet groups met in weekly counseling sessions for 4 weeks , followed by 11 monthly sessions . Participants on the low-carbohydrate diet were instructed only to reduce carbohydrate intake to less than 30 g per day . Participants on the conventional diet were instructed to reduce caloric intake by 500 calories per day , with less than 30 % of calories derived from fat , in accordance with the National Heart , Lung , and Blood Institute guidelines ( 3 ) . Outcome Measures We collected data , including weight ( single calibrated scale , SR Instruments , Inc. , Tonaw and a , New York ) , medical history ( self-reported ) , and blood pressure , at baseline , 6 months , and 1 year . Fasting blood specimens were obtained for glucose , hemoglobin A1c , and serum lipid levels ( Synchron LX20 , Beckman Coulter , Inc. , Fullerton , California ) . Low-density lipoprotein ( LDL ) cholesterol level was calculated by using the Friedewald formula ( 9 ) . We defined the presence of diabetes by a historical fasting blood glucose level greater than 6.94 mmol/L ( > 125 mg/dL ) or use of antidiabetic medications . The metabolic syndrome was considered present if a participant had 3 or more of the following ( 10 ) : central obesity , fasting blood glucose level of 6.11 mmol/L ( 110 mg/dL ) or greater , fasting triglyceride level of 1.70 mmol/L ( 150 mg/dL ) or greater , high-density lipoprotein ( HDL ) cholesterol level less than 1.04 mmol/L ( blood pressure of 130/85 mm Hg or greater , or antihypertensive therapy . We assumed that all participants had central obesity because of the uniform severity of their obesity ( BMI range , 35.0 to 79.4 kg/m2 ) . Serum insulin was measured by radioimmunoassay ( Laboratory Corporation of America Holdings [ LabCorp ] , Burlington , North Carolina ] ) . Insulin resistance in nondiabetic persons was estimated by the quantitative insulin sensitivity check ( QUICK ) index : 1/[(log ( fasting insulin ( U/mL ) ) + ( log fasting glucose(mg/dL ) ) ] . Statistical Analysis Our primary end point was total weight loss at 1 year . Secondary analyses included the change from baseline in serum lipid levels , insulin sensitivity , and glycemic control . We estimated that we would need 100 persons ( 50 per group ) , assuming a 2-sided type I error of 5 % , for the study to have 80 % power to detect a 5-kg greater mean weight loss in the low-carbohydrate group than in the conventional diet group . These calculations were based on an anticipated maximum weight loss by 6 months , with weight stabilization in both diet groups between 6 months and 1 year . To compensate for an anticipated dropout rate of 25 % , we set our enrollment target at 135 persons . R and omization was performed by using a pre-established algorithm generated from a r and om set of numbers that was constructed and held in a separate center and concealed from those enrolling persons during r and omization . We used stratified r and omization , with blocking within strata , to ensure assignment of approximately equal numbers of women , diabetic persons , and severely obese persons ( BMI 40 kg/m2 ) to each study group . Changes in weight , dietary intake , and metabolic data were compared between the 2 diets by r and om-coefficient analysis ( 11 ) . This type of analysis was selected to allow for a variable number of observations for participants and to take into account that the repeated observations of the outcome variables over time for individuals were correlated . The r and om-coefficient analysis model takes these correlations into account by allowing the intercept to vary r and omly among persons . We used a restricted maximum likelihood analysis , which assumed that changes were distributed according to a bivariate normal distribution and that data were missing at r and om . The outcome variables were changes from baseline in weight , dietary macronutrient consumption , and metabolic measurements . For all of these analyses , the covariates included an indicator variable for time ( 6 months and 1 year ) , diet group , and a diet group by time interaction term . This diet group by time interaction term was kept in the model , regardless of its statistical significance ( P = 0.063 for the weight loss analysis ) . Separate analyses to adjust for baseline differences between diet groups were also made by entering the following covariates to each of these models : age ; race ( white or African American ) ; sex ; baseline BMI ; baseline caloric intake ; and the presence or absence of hypertension , use of lipid-lowering therapy , diabetes , active smoking , and sleep apnea ( 12 ) . All variables were assessed for normality before entry into the analyses . Triglyceride , insulin , and glucose levels were skewed and thus were log-transformed before the analyses . Baseline differences between diet groups were compared by chi-square analysis for dichotomous variables and by the unpaired t-test for continuous variables . All P values are 2-sided , and a P value of 0.05 was considered statistically significant . Analyses were performed with SPSS statistical software , version 11.1 ( SPSS , Inc. , Chicago , Illinois ) . Missing Data Of the 132 enrolled persons , follow-up was done at 6 months for 79 persons and at 1 year for 87 persons . For measurements at 6 months , we retrieved weights on an additional 16 persons on the low-carbohydrate diet and 23 persons on the conventional diet ( total , 39 persons at a mean [ SD ] of 6.6 1.2 months ) . For measurements at 1 year , we retrieved weights on 18 persons on the low-carbohydrate diet and 21 persons on the conventional diet ( total , 39 persons at a mean [ SD ] of 13.5 3.2 months ) . Thus , we had 6-month weights on 118 of 132 persons ( 89 % ) and 1-year weights on 126 of 132 persons ( 96 % ) . Of the 18 persons who missed the 6-month visit but returned for the 1-year visit ( 6 in the low-carbohydrate group and 12 in the conventional diet group ) , all but 2 had 6-month weights retrieved from medical records . Of the 6 persons for whom no 1-year weights were available , 2 were in the low-carbohydrate group and 4 in the conventional diet group . The weights retrieved from medical records were obtained on scales that were different from those used for the study and were probably obtained in a nonuniform manner with regard to clothing . We used several approaches to h and le the 45 participants with missing data for diet recall and metabolic measurements . For the primary analysis by r and om-coefficient analysis , we assumed data were missing at r and om . To verify this assumption , we performed sensitivity analyses based on comparisons of baseline characteristics and weight loss differences between those who dropped out and those who completed the study . We also performed 2 additional sensitivity",
"Background Our aim was to compare the effects of a Paleolithic ( ' Old Stone Age ' ) diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin . Methods In a r and omized cross-over study , 13 patients with type 2 diabetes , 3 women and 10 men , were instructed to eat a Paleolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; and a Diabetes diet design ed in accordance with dietary guidelines during two consecutive 3-month periods . Outcome variables included changes in weight , waist circumference , serum lipids , C-reactive protein , blood pressure , glycated haemoglobin ( HbA1c ) , and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test . Dietary intake was evaluated by use of 4-day weighed food records . Results Study participants had on average a diabetes duration of 9 years , a mean HbA1c of 6,6 % units by Mono-S st and ard and were usually treated with metformin alone ( 3 subjects ) or metformin in combination with a sulfonylurea ( 3 subjects ) or a thiazolidinedione ( 3 subjects ) . Mean average dose of metformin was 1031 mg per day . Compared to the diabetes diet , the Paleolithic diet result ed in lower mean values of HbA1c ( -0.4 % units , p = 0.01 ) , triacylglycerol ( -0.4 mmol/L , p = 0.003 ) , diastolic blood pressure ( -4 mmHg , p = 0.03 ) , weight ( -3 kg , p = 0.01 ) , BMI ( -1 kg/m2 , p = 0.04 ) and waist circumference ( -4 cm , p = 0.02 ) , and higher mean values of high density lipoprotein cholesterol ( + 0.08 mmol/L , p = 0.03 ) . The Paleolithic diet was mainly lower in cereals and dairy products , and higher in fruits , vegetables , meat and eggs , as compared with the Diabetes diet . Further , the Paleolithic diet was lower in total energy , energy density , carbohydrate , dietary glycemic load , saturated fatty acids and calcium , and higher in unsaturated fatty acids , dietary cholesterol and several vitamins . Dietary GI was slightly lower in the Paleolithic diet ( GI = 50 ) than in the Diabetic diet ( GI = 55 ) . Conclusion Over a 3-month study period , a Paleolithic diet improved glycemic control and several cardiovascular risk factors compared to a Diabetes diet in patients with type 2 diabetes . Trial registration Clinical Trials.gov NCT00435240",
"BACKGROUND Adherence to a Mediterranean diet may improve longevity , but relevant data are limited . METHODS We conducted a population -based , prospect i ve investigation involving 22,043 adults in Greece who completed an extensive , vali date d , food-frequency question naire at base line . Adherence to the traditional Mediterranean diet was assessed by a 10-point Mediterranean-diet scale that incorporated the salient characteristics of this diet ( range of scores , 0 to 9 , with higher scores indicating greater adherence ) . We used proportional-hazards regression to assess the relation between adherence to the Mediterranean diet and total mortality , as well as mortality due to coronary heart disease and mortality due to cancer , with adjustment for age , sex , body-mass index , physical-activity level , and other potential confounders . RESULTS During a median of 44 months of follow-up , there were 275 deaths . A higher degree of adherence to the Mediterranean diet was associated with a reduction in total mortality ( adjusted hazard ratio for death associated with a two-point increment in the Mediterranean-diet score , 0.75 [ 95 percent confidence interval , 0.64 to 0.87 ] ) . An inverse association with greater adherence to this diet was evident for both death due to coronary heart disease ( adjusted hazard ratio , 0.67 [ 95 percent confidence interval , 0.47 to 0.94 ] ) and death due to cancer ( adjusted hazard ratio , 0.76 [ 95 percent confidence interval , 0.59 to 0.98 ] ) . Associations between individual food groups contributing to the Mediterranean-diet score and total mortality were generally not significant . CONCLUSIONS Greater adherence to the traditional Mediterranean diet is associated with a significant reduction in total mortality",
"OBJECTIVE —The purpose of this study was to compare the effects of high – monounsaturated fatty acid ( MUFA ) and high-carbohydrate ( CHO ) diets on body weight and glycemic control in men and women with type 2 diabetes . RESEARCH DESIGN AND METHODS —Overweight/obese participants with type 2 diabetes ( n = 124 , age = 56.5 ± 0.8 years , BMI = 35.9 ± 0.3 kg/m2 , and A1C = 7.3 ± 0.1 % ) were r and omly assigned to 1 year of a high-MUFA or high-CHO diet . Anthropometric and metabolic parameters were assessed at baseline and after 4 , 8 , and 12 months of dieting . RESULTS —Baseline characteristics were similar between the treatment groups . The overall retention rate for 1 year was 77 % ( 69 % for the high-MUFA group and 84 % for the high-CHO group ; P = 0.06 ) . Based on food records , both groups had similar energy intake but a significant difference in MUFA intake . Both groups had similar weight loss over 1 year ( −4.0 ± 0.8 vs. −3.8 ± 0.6 kg ) and comparable improvement in body fat , waist circumference , diastolic blood pressure , HDL cholesterol , A1C , and fasting glucose and insulin . There were no differences in these parameters between the groups . A follow-up assessment of a subset of participants ( n = 36 ) was conducted 18 months after completion of the 52-week diet . These participants maintained their weight loss and A1C during the follow-up period . CONCLUSIONS —In individuals with type 2 diabetes , high-MUFA diets are an alternative to conventional lower-fat , high-CHO diets with comparable beneficial effects on body weight , body composition , cardiovascular risk factors , and glycemic control",
"Aims /hypothesisTo compare the effectiveness of low-fat high-protein and low-fat high-carbohydrate dietary advice on weight loss , using group-based interventions , among overweight people with type 2 diabetes . Study design Multicentre parallel ( 1:1 ) design , blinded r and omised controlled trial . Methods Individuals with type 2 diabetes aged 30–75 years and a BMI > 27 kg/m2 were r and omised , by an independent statistician using sequentially numbered sealed envelopes , to be prescribed either a low-fat high-protein ( 30 % of energy as protein , 40 % as carbohydrate , 30 % as fat ) or a low-fat high-carbohydrate ( 15 % of energy as protein , 55 % as carbohydrate , 30 % as fat ) diet . Participants attended 18 group sessions over 12 months . Primary outcomes were change in weight and waist circumference assessed at baseline , 6 and 12 months . Secondary outcomes were body fatness , glycaemic control , lipid profile , blood pressure and renal function . A further assessment was undertaken 12 months after the intervention . Research assessors remained blinded to group allocation throughout . Intention-to-treat analysis was performed . Results A total of 419 participants were enrolled ( mean ± SD age 58 ± 9.5 years , BMI 36.6 ± 6.5 kg/m2 and HbA1c 8.1 ± 1.2 % ( 65 mmol/mol ) ) . The study was completed by 70 % ( 294/419 ) . No differences between groups were found in change in weight or waist circumference during the intervention phase or the 12-month follow-up . Both groups had lost weight ( 2–3 kg , p their waist circumference ( 2–3 cm , p weight loss for the following 12 months . By 6 months , the difference in self-reported dietary protein between groups was small ( 1.1 % total energy ; p outcomes : body fatness , HbA1c , lipids , blood pressure and renal function . There were no important adverse effects . Conclusions /interpretationIn a ‘ real-world ’ setting , prescription of an energy-reduced low-fat diet , with either increased protein or carbohydrate , results in similar modest losses in weight and waist circumference over 2 years . Trial registration : Australia New Zeal and Clinical Trials Register ACTRN12606000490572 Funding : The Health Research Council of New Zeal and ( 06/337 )",
"Background We lack a comprehensive assessment of the risks and benefits of calorie restriction in older adults at high risk for cardiometabolic disease . Calorie restriction may reduce visceral adipose tissue ( VAT ) but also have negative effects on lean mass and quality of life . Methods We conducted a 52-week , r and omized controlled trial involving 164 older adults with obesity taking at least one medication for hyperlipidemia , hypertension , or diabetes . Interventions included an exercise intervention alone ( Exercise ) , or with diet modification and body weight maintenance ( Maintenance ) , or with diet modification and energy restriction ( Weight Loss ) . The primary outcome was change in VAT at 12 months . Secondary outcomes included cardiometabolic risk factors , functional status , and quality of life . Results A total of 148 participants had measured weight at 12 months . Despite loss of -1.6 % ± 0.3 % body fat and 4.1 % ± 0.7 % initial body weight , Weight Loss did not have statistically greater loss of VAT ( -192.6 ± 185.2 cm3 ) or lean mass ( -0.4 ± 0.3 kg ) compared with Exercise ( VAT = -21.9 ± 173.7 cm3 ; lean mass = 0.3 ± 0.3 kg ) . Quality of life improved in all groups with no differences between groups . No significant changes in physical function were observed . Weight Loss had significantly greater improvements in blood glucose ( -8.3 ± 3.6 mg/dL , p and HDL-cholesterol ( 5.3 ± 1.9 , p with Exercise . There were no group differences in the frequency of adverse events . Conclusions While moderate calorie restriction did not significantly decrease VAT in older adults at high risk for cardiometabolic disease , it did reduce total body fat and cardiometabolic risk factors without significantly more adverse events and lean mass loss",
"BACKGROUND Weight loss reduces blood pressure , and the Dietary Approaches to Stop Hypertension ( DASH ) diet has also been shown to lower blood pressure . OBJECTIVE Our goal was to assess the effect on blood pressure of 2 weight-reduction diets : a low-fat diet ( LF diet ) and a moderate-sodium , high-potassium , high-calcium , low-fat DASH diet ( WELL diet ) . DESIGN After baseline measurements , 63 men were r and omly assigned to either the WELL or the LF diet for 12 wk , and both diet groups undertook 0.5 h of moderate physical activity on most days of the week . RESULTS Fifty-four men completed the study . Their mean ( + /-SD ) age was 47.9 + /- 9.3 y ( WELL diet , n = 27 ; LF diet , n = 27 ) , and their mean baseline home systolic and diastolic blood pressures were 129.4 + /- 11.3 and 80.6 + /- 8.6 mm Hg , respectively . Body weight decreased by 4.9 + /- 0.6 kg ( + /-SEM ) in the WELL group and by 4.6 + /- 0.6 kg in the LF group ( P blood pressure in the WELL group than in the LF group [ between-group difference ( week 12 -baseline ) in both SBP ( 5.5 + /- 1.9 mm Hg ; P = 0.006 ) and DBP ( 4.4 + /- 1.2 mm Hg ; P = 0.001 ) ] . CONCLUSIONS For a comparable 5-kg weight loss , a diet high in low-fat dairy products , vegetables , and fruit ( the WELL diet ) result ed in a greater decrease in blood pressure than did the LF diet . This dietary approach to achieving weight reduction may confer an additional benefit in reducing blood pressure in those who are overweight",
"Studies in women with type 2 diabetes demonstrated adverse effects on body fat distribution of a low-fat diet relative to a high monounsaturated fat diet . We performed a r and omized 12-wk parallel design study of two 6000-kJ diets : 35 % energy from fat ( high monounsaturated fat diet , HIMO ) , or 12 % energy from fat ( very low-fat diet , VLF ) to determine whether this also occurred in nondiabetic women . Body fat distribution , fasting plasma glucose , blood pressure , and fasting serum lipids were measured at wk 0 and 12 in 62 women ( BMI > 27 kg/m(2 ) ) . Weight loss ( 9.5 + /- 2.4 vs. 9.4 + /- 3.4 kg , VLF vs. HIMO ) and total fat loss ( 6.1 + /- 2.4 vs. 6.3 + /- 2.7 kg , VLF vs. HIMO ) did not differ in the groups . There was a diet x menopausal status interaction in lean mass changes ( P = 0.005 ) such that in premenopausal women , HIMO produced a lower loss of lean mass than the low-fat diet ( 0.4 + /- 2.3 vs. 2.9 + /- 2.7 kg , P = 0.006 ) with the opposite but nonsignificant effect seen in postmenopausal women . There was a greater decrease in total plasma cholesterol in women who consumed VLF compared with those who consumed HIMO ( 0.82 + /- 0.0.51 vs. 0.50 + /- 0.48 mmol/L , P HDL cholesterol ( 0.18 + /- 0.23 vs. 0.04 + /- 0.19 mmol/L , VLF and HIMO , respectively , P LDL/HDL ratio was reduced in both groups with no effect of diet ( 0.16 + /- 0.51 vs. 0.16 + /- 0.45 , VLF and HIMO , respectively , P weight , total fat mass , and regional fat mass loss did not differ in the 2 groups of women but there was an apparent preservation of lean mass in premenopausal women consuming HIMO",
"BACKGROUND Few well-controlled studies have comprehensively examined the effects of very-low-carbohydrate diets on type 2 diabetes ( T2D ) . OBJECTIVE We compared the effects of a very-low-carbohydrate , high-unsaturated fat , low-saturated fat ( LC ) diet with a high-carbohydrate , low-fat ( HC ) diet on glycemic control and cardiovascular disease risk factors in T2D after 52 wk . DESIGN In this r and omized controlled trial that was conducted in an outpatient research clinic , 115 obese adults with T2D [ mean ± SD age : 58 ± 7 y ; body mass index ( in kg/m(2 ) ) : 34.6 ± 4.3 ; glycated hemoglobin ( HbA1c ) : 7.3 ± 1.1 % ; duration of diabetes : 8 ± 6 y ] were r and omly assigned to consume either a hypocaloric LC diet [ 14 % of energy as carbohydrate ( carbohydrate ] or an energy-matched HC diet [ 53 % of energy as carbohydrate , 17 % of energy as protein , and 30 % of energy as fat ( 10 % saturated fat ) ] combined with supervised aerobic and resistance exercise ( 60 min ; 3 d/wk ) . Outcomes were glycemic control assessed with use of measurements of HbA1c , fasting blood glucose , glycemic variability assessed with use of 48-h continuous glucose monitoring , diabetes medication , weight , blood pressure , and lipids assessed at baseline , 24 , and 52 wk . RESULTS Both groups achieved similar completion rates ( LC diet : 71 % ; HC diet : 65 % ) and mean ( 95 % CI ) reductions in weight [ LC diet : -9.8 kg ( -11.7 , -7.9 kg ) ; HC diet : -10.1 kg ( -12.0 , -8.2 kg ) ] , blood pressure [ LC diet : -7.1 ( -10.6 , -3.7)/-6.2 ( -8.2 , -4.1 ) mm Hg ; HC diet : -5.8 ( -9.4 , -2.2)/-6.4 ( -8.4 , -4.3 ) mm Hg ] , HbA1c [ LC diet : -1.0 % ( -1.2 % , -0.7 % ) ; HC diet : -1.0 % ( -1.3 % , -0.8 % ) ] , fasting glucose [ LC diet : -0.7 mmol/L ( -1.3 , -0.1 mmol/L ) ; HC diet : -1.5 mmol/L ( -2.1 , -0.8 mmol/L ) ] , and LDL cholesterol [ LC diet : -0.1 mmol/L ( -0.3 , 0.1 mmol/L ) ; HC diet : -0.2 mmol/L ( -0.4 , 0.03 mmol/L ) ] ( P-diet effect ≥ 0.10 ) . Compared with the HC-diet group , the LC-diet group achieved greater mean ( 95 % CI ) reductions in the diabetes medication score [ LC diet : -0.5 arbitrary units ( -0.7 , -0.4 arbitrary units ) ; HC diet : -0.2 arbitrary units ( -0.4 , -0.06 arbitrary units ) ; P = 0.02 ] , glycemic variability assessed by measuring the continuous overall net glycemic action-1 [ LC diet : -0.5 mmol/L ( -0.6 , -0.3 mmol/L ) ; HC diet : -0.05 mmol/L ( -0.2 , -0.1 mmol/L ) ; P = 0.003 ] , and triglycerides [ LC diet : -0.4 mmol/L ( -0.5 , -0.2 mmol/L ) ; HC diet : -0.01 mmol/L ( -0.2 , 0.2 mmol/L ) ; P = 0.001 ] and greater mean ( 95 % CI ) increases in HDL cholesterol [ LC diet : 0.1 mmol/L ( 0.1 , 0.2 mmol/L ) ; HC diet : 0.06 mmol/L ( -0.01 , 0.1 mmol/L ) ; P = 0.002 ] . CONCLUSIONS Both diets achieved substantial weight loss and reduced HbA1c and fasting glucose . The LC diet , which was high in unsaturated fat and low in saturated fat , achieved greater improvements in the lipid profile , blood glucose stability , and reductions in diabetes medication requirements , suggesting an effective strategy for the optimization of T2D management . This trial was registered at www.anzctr.org.au as ACTRN12612000369820",
"Hypertension is one of the leading causes of morbidity and mortality in Brazil . Diet may play an important role in reducing blood pressure ( BP ) , as has been shown for diets high in fruits , vegetables and low-fat dairy products and low in salt ( Dietary Approaches to Stop Hypertension (DASH)-Na ) . A low-glycaemic index Brazilian diet combined with the principles of the DASH-Na diet was evaluated in a r and omised study of 206 individuals who were followed for 6 months . In the control group ( CG ) , counselling was based on st and ard care and mainly focused on salt intake reduction . An intention-to-treat analysis showed that , after 6 months , systolic BP was reduced by 14·4 mmHg and diastolic BP by 9·7 mmHg in the experimental group ( EG ) , compared with 6·7 and 4·6 mmHg , respectively , in the CG . After adjusting for body weight , BP at baseline and age , these changes were 12·1 and 7·9 mmHg , respectively . Urinary Na excretion was also reduced by 43·4 mEq/24 h in the EG . Food intake was modified accordingly during the intervention with an increase in the consumption of vegetables ( 2·97 - 5·85 frequency of consumption measured in three non-consecutive days ) , fruits ( 4·09 - 7·18 ) , beans ( 1·94 - 3·13 ) and fish ( 1·80 - 2·74 ) by the EG . The present study showed the feasibility of a Brazilian dietary approach to treating hypertension by reducing urinary Na excretion and BP , changes that may have a great impact on public health and promote the benefits of controlling hypertension",
"This r and omised controlled trial examined anthropometric changes and cardiovascular benefits of six months of weight management in 110 free living women , aged 18–68 y and BMI 25–50 kg/m2 , who received 1200 kcal/d diet treatments of either high ( 58 % energy , n=57 ) or low ( 35 % energy , n=53 ) carbohydrate ( CHO ) content . Body weight , plasma total , HDL and LDL cholesterol , triglyceride and blood pressure were measured . Examination at three months showed women on high CHO lost ( mean±s.e.m . ) 4.3±0.5 kg and those on low CHO lost 5.6±0.6 kg of body weight . Changes in risk factors did not significantly differ between the two diet treatments throughout the study . However those on high CHO diets significantly lowered their plasma total cholesterol by 0.33 mmol/l ( 95 % CI : 0.10 , 0.55 ) , LDL cholesterol by 0.23 mmol/l ( 0.02 , 0.43 ) and HDL cholesterol by 0.05 mmol/l ( 0.03 , 0.10 ) , while women on low CHO diets lowered only plasma triglyceride by 0.28 mmol/l ( 0.08 , 0.48 ) . Blood pressure did not change significantly on either diet . After six months , women on high CHO lost 5.6±0.8 kg and those on low CHO lost 6.8±0.8 kg . On the high CHO diet , total cholesterol remained significantly below the baseline value at 0.34 mmol/l ( 0.13 , 0.56 ) , triglyceride was significantly lowered by 0.27 mmol/l ( 0.10 , 0.45 ) , and HDL cholesterol returned to the baseline value . On the low CHO diet , triglyceride remained the only risk factor to be significantly improved . A subgroup of 46 postmenopausal women lost significantly ( P on the low CHO diet than high CHO diet . In conclusion , these results provided some support for preferring a high CHO diet to a lower CHO approach in weight management , from the point of view of risk reduction , but do not indicate a consistently more rapid weight loss with either diet",
"Background Hypertension can be prevented by adopting healthy dietary patterns . Our aim was to assess the 4-year effect on blood pressure ( BP ) control of a r and omized feeding trial promoting the traditional Mediterranean dietary pattern . Methods The PREDIMED primary prevention trial is a r and omized , single-blinded , controlled trial conducted in Spanish primary healthcare centers . We recruited 7,447 men ( aged 55 to 80 years ) and women ( aged 60 to 80 years ) who had high risk for cardiovascular disease . Participants were assigned to a control group or to one of two Mediterranean diets . The control group received education on following a low-fat diet , while the groups on Mediterranean diets received nutritional education and also free foods ; either extra virgin olive oil , or nuts . Trained personnel measured participants ’ BP at baseline and once yearly during a 4-year follow-up . We used generalized estimating equations to assess the differences between groups during the follow-up . Results The percentage of participants with controlled BP increased in all three intervention groups ( P-value for within-group changes : P significantly lower diastolic BP than the participants in the control group ( −1.53 mmHg ( 95 % confidence interval ( CI ) −2.01 to −1.04 ) for the Mediterranean diet supplemented with extra virgin olive oil , and −0.65 mmHg ( 95 % CI -1.15 to −0.15 ) mmHg for the Mediterranean diet supplemented with nuts ) . No between-group differences in changes of systolic BP were seen . Conclusions Both the traditional Mediterranean diet and a low-fat diet exerted beneficial effects on BP and could be part of advice to patients for controlling BP . However , we found lower values of diastolic BP in the two groups promoting the Mediterranean diet with extra virgin olive oil or with nuts than in the control group . Trial registration Current Controlled Trials IS RCT",
"BACKGROUND Lifestyle changes soon after diagnosis might improve outcomes in patients with type 2 diabetes mellitus , but no large trials have compared interventions . We investigated the effects of diet and physical activity on blood pressure and glucose concentrations . METHODS We did a r and omised , controlled trial in southwest Engl and in adults aged 30 - 80 years in whom type 2 diabetes had been diagnosed 5 - 8 months previously . Participants were assigned usual care ( initial dietary consultation and follow-up every 6 months ; control group ) , an intensive diet intervention ( dietary consultation every 3 months with monthly nurse support ) , or the latter plus a pedometer-based activity programme , in a 2:5:5 ratio . The primary endpoint was improvement in glycated haemoglobin A(1c)(HbA(1c ) ) concentration and blood pressure at 6 months . Analysis was done by intention to treat . This study is registered , number IS RCT N92162869 . FINDINGS Of 593 eligible individuals , 99 were assigned usual care , 248 the diet regimen , and 246 diet plus activity . Outcome data were available for 587 ( 99 % ) and 579 ( 98 % ) participants at 6 and 12 months , respectively . At 6 months , glycaemic control had worsened in the control group ( mean baseline HbA(1c ) percentage 6·72 , SD 1·02 , and at 6 months 6·86 , 1·02 ) but improved in the diet group ( baseline-adjusted difference in percentage of HbA(1c ) -0·28 % , 95 % CI -0·46 to -0·10 ; p=0·005 ) and diet plus activity group ( -0·33 % , -0·51 to -0·14 ; p seen in bodyweight and insulin resistance between the intervention and control groups . Blood pressure was similar in all groups . INTERPRETATION An intensive diet intervention soon after diagnosis can improve glycaemic control . The addition of an activity intervention conferred no additional benefit . FUNDING Diabetes UK and the UK Department of Health",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Abstract Purpose The New Nordic Diet ( NND ) has induced weight loss in a 26-week controlled intervention . We aim to investigate whether high compliance and satisfaction can be maintained after the active intervention is discontinued thereby maintaining the health effects . Methods After 26 weeks of intervention with NND or Average Danish Diet ( ADD ) , 147 participants ( mean age 43 years and mean BMI 29.1 kg/m2 ) were followed for further 52 weeks . All participants were encouraged to follow NND but without further guidance . The study is registered with Clinical Trials.gov , study i d NCT01195610 . Results One hundred and ten participants ( 75 % ) completed the follow-up . Among participants previously r and omised to NND ( NND group ) , dietary compliance and satisfaction decreased from 4.3 to 3.0 and from 4.8 to 4.0 , respectively ( both p satisfaction with NND was significantly higher than with ADD during follow-up ( 3.3 vs. 2.5 , p = 0.026 ) . Weight losses during intervention of −6.2 kg and −3.0 kg were followed by regains of 4.6 kg ( SE 0.5 ) and 1.1 kg ( SE 0.7 ) for the NND group and ADD group , respectively [ adjusted difference ; mean ( 95 % CI ) : 1.8 kg ( 0.1–3.4 ) , p = 0.041 ] . Across diet groups , every 1 score higher in compliance with NND was associated with 0.90 kg less body weight regain ( p = 0.026 ) and those who increased physical activity regained 3.4 kg less compared to those who did not ( p Conclusions NND provides higher satisfaction , and body weight regain is reduced with higher compliance with NND and increased physical activity",
"BACKGROUND To test alternative medicine approaches with a specifically design ed Tibetan dietary and behavioral program in patients with established coronary artery disease ( CAD ) and manifest metabolic syndrome . METHODS This was a r and omized , controlled , double-blinded , parallel group dietary and behavioral intervention study . Between December 2008 and November 2010 , patients were r and omly adjudicated either to evidence -based Western diet ( usual care ) , or to Tibetan diet . We evaluated 524 patients undergoing coronary angiography . All patients were white Caucasian , presented with a body mass index ( BMI ) > 25 kg/m(2 ) , and had evidence of metabolic syndrome . The primary endpoint was change in body weight and BMI at 6 months follow-up . Secondary endpoints included blood pressure , heart rate , intima media thickness , lipids , fasting glucose , glycated hemoglobin , fibrinogen , C-reactive protein ( CRP ) at 6 months follow-up and change in body weight and BMI at 12 months . RESULTS Both groups of patients showed significantly reduced body weight and BMI compared to baseline ( 6 months , usual care weight change : -3.2 ± 3.0 kg ; BMI change : -1.1 ± 1.0 kg/m(2 ) ; Tibetan diet weight change : -6.2 ± 4.4 kg/m(2 ) ; BMI change : -2.1 ± 1.5 kg/m(2 ) ) , but these changes were more pronounced in Tibetan diet compared to usual care ( all , p ) . Beneficial effects on weight and BMI were maintained after 12 months of follow-up ( p CRP were decreased in both groups , but more pronounced in Tibetan diet ( Tibetan diet vs. usual care ( total cholesterol ) : 176.2 ± 43.7 vs. 185.1 ± 47.8 mg/dL ; p=0.024 ; LDL : 111.6 ± 37.8 vs. 119.4 ± 40.9 mg/dL ; p=0.026 ; fibrinogen : 318.3 ± 90.4 vs. 334.1 ± 87.9 mg/dL ; p=0.040 ; CRP : 1.2 ± 3.0 vs. 2.2 ± 4.5mg/dL ; p=0.036 ) . CONCLUSIONS Tibetan diet reduces body weight and BMI in patients with CAD and metabolic syndrome after 6 months significantly better than Western diet and may induce lipid-modifying and anti-inflammatory effects ( Clinical Trials.gov identifier : NCT00810992 )",
"OBJECTIVE : To compare the long-term compliance and effects of two low-fat diets differing in carbohydrate to protein ratio on body composition and biomarkers of cardiovascular disease risk in obese subjects with hyperinsulinemia . DESIGN : Outpatient , parallel , clinical intervention study of two groups of subjects r and omly assigned to either a st and ard protein ( SP ; 15 % protein , 55 % carbohydrate ) or high-protein ( HP ; 30 % protein , 40 % carbohydrate ) diet , during 12 weeks of energy restriction ( ∼6.5 MJ/day ) and 4 weeks of energy balance ( ∼8.3 MJ/day ) . Subsequently , subjects were asked to maintain the same dietary pattern for the succeeding 52 weeks with minimal professional support . SUBJECTS : A total of 58 obese , nondietetic subjects with hyperinsulinemia ( 13 males/45 females , mean age 50.2 y , mean body mass index ( BMI ) 34.0 kg/m2 , mean fasting insulin 17.8 mU/l ) participated in the study . MEASUREMENTS : Body composition , blood pressure , blood lipids , fasting glucose , insulin , CRP and sICAM-1 were measured at baseline and at weeks 16 and 68 . Urinary urea/creatinine ratio was measured at baseline , week 16 and at 3 monthly intervals thereafter . RESULTS : In total , 43 subjects completed the study with similar dropouts in each group ( P=0.76 ) . At week 68 , there was net weight loss ( SP −2.9±3.6 % , HP −4.1±5.8 % ; P fat loss ( P significantly increased HDL cholesterol concentrations ( P and decreased fasting insulin , insulin resistance , sICAM-1 and CRP levels ( P ) . Protein intake was significantly greater in HP during the initial 16 weeks ( P achieved net weight loss and improvements in cardiovascular risk factors ",
"CONTEXT The scarcity of data addressing the health effects of popular diets is an important public health concern , especially since patients and physicians are interested in using popular diets as individualized eating strategies for disease prevention . OBJECTIVE To assess adherence rates and the effectiveness of 4 popular diets ( Atkins , Zone , Weight Watchers , and Ornish ) for weight loss and cardiac risk factor reduction . DESIGN , SETTING , AND PARTICIPANTS A single-center r and omized trial at an academic medical center in Boston , Mass , of overweight or obese ( body mass index : mean , 35 ; range , 27 - 42 ) adults aged 22 to 72 years with known hypertension , dyslipidemia , or fasting hyperglycemia . Participants were enrolled starting July 18 , 2000 , and r and omized to 4 popular diet groups until January 24 , 2002 . INTERVENTION A total of 160 participants were r and omly assigned to either Atkins ( carbohydrate restriction , n=40 ) , Zone ( macronutrient balance , n=40 ) , Weight Watchers ( calorie restriction , n=40 ) , or Ornish ( fat restriction , n=40 ) diet groups . After 2 months of maximum effort , participants selected their own levels of dietary adherence . MAIN OUTCOME MEASURES One-year changes in baseline weight and cardiac risk factors , and self-selected dietary adherence rates per self-report . RESULTS Assuming no change from baseline for participants who discontinued the study , mean ( SD ) weight loss at 1 year was 2.1 ( 4.8 ) kg for Atkins ( 21 [ 53 % ] of 40 participants completed , P = .009 ) , 3.2 ( 6.0 ) kg for Zone ( 26 [ 65 % ] of 40 completed , P = .002 ) , 3.0 ( 4.9 ) kg for Weight Watchers ( 26 [ 65 % ] of 40 completed , P low-density lipoprotein/high-density lipoprotein ( HDL ) cholesterol ratio by approximately 10 % ( all P blood pressure or glucose at 1 year . Amount of weight loss was associated with self-reported dietary adherence level ( r = 0.60 ; P total/HDL cholesterol , C-reactive protein , and insulin were significantly associated with weight loss ( mean r = 0.36 , 0.37 , and 0.39 , respectively ) with no significant difference between diets ( P = .48 , P = .57 , P = .31 , respectively ) . CONCLUSIONS Each popular diet modestly reduced body weight and several cardiac risk factors at 1 year . Overall dietary adherence rates were low , although increased adherence was associated with greater weight loss and cardiac risk factor reductions for each diet group",
" 28 patients who had a sustained diastolic blood pressure of 95 to 104 mm Hg and who had no treatment for it for at least 13 months before the trial , but who were otherwise unselected , took part in a r and omised controlled trial in which the effect of a restricted sodium diet was compared with that of a general health package . The general health package did not include any specific hypotensive procedures . Changes in blood pressure were measured at predetermined intervals over the course of a year . Within each group both systolic and diastolic blood pressure fell to a highly significant extent after a year , but there was no significant difference between the groups . It would thus seem that the antihypertensive effect of a restricted sodium diet may be related to the increased consultation and monitoring activity of such intervention rather than to the dietary manipulation itself",
"OBJECTIVE To evaluate the effects of two low-fat hypocaloric diets differing in the carbohydrate-to-protein ratio , with and without resistance exercise training ( RT ) , on weight loss , body composition , and cardiovascular disease ( CVD ) risk outcomes in overweight/obese patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 83 men and women with type 2 diabetes ( aged 56.1 ± 7.5 years , BMI 35.4 ± 4.6 kg/m2 ) were r and omly assigned to an isocaloric , energy-restricted diet ( female subjects 6 MJ/day , male subjects 7 MJ/day ) of either st and ard carbohydrate ( CON ; carbohydrate : protein : fat 53:19:26 ) or high protein ( HP ; 43:33:22 ) , with or without supervised RT ( 3 days/week ) for 16 weeks . Body weight and composition , waist circumference ( WC ) , and cardiometabolic risk markers were assessed . RESULTS Fifty-nine participants completed the study . There was a significant group effect ( P ≤ 0.04 ) for body weight , fat mass , and WC with the greatest reductions occuring in HP+RT ( weight [ CON : −8.6 ± 4.6 kg , HP : −9.0 ± 4.8 kg , CON+RT : −10.5 ± 5.1 kg , HP+RT : −13.8 ± 6.0 kg ] , fat mass [ CON : −6.4 ± 3.4 kg , HP : −6.7 ± 4.0 kg , CON+RT : −7.9 ± 3.7 kg , HP+RT : −11.1 ± 3.7 kg ] , and WC [ CON : −8.2 ± 4.6 cm , HP : −8.9 ± 3.9 cm , CON+RT : −11.3 ± 4.6 cm , HP+RT : −13.7 ± 4.6 cm ] ) . There was an overall reduction ( P mass ( −2.0 ± 2.3 kg ) , blood pressure ( −15/8 ± 10/6 mmHg ) , glucose ( −2.1 ± 2.2 mmol/l ) , insulin ( −4.7 ± 5.4 mU/l ) , A1C ( −1.25 ± 0.94 % ) , triglycerides ( −0.47 ± 0.81 mmol/l ) , total cholesterol ( −0.67 ± 0.69 mmol/l ) , and LDL cholesterol ( −0.37 ± 0.53 mmol/l ) , with no difference between groups ( P ≥ 0.17 ) . CONCLUSIONS An energy-restricted HP diet combined with RT achieved greater weight loss and more favorable changes in body composition . All treatments had similar improvements in glycemic control and CVD risk markers ",
"BACKGROUND It is known that obesity , sodium intake , and alcohol consumption factors influence blood pressure . In this clinical trial , Dietary Approaches to Stop Hypertension , we assessed the effects of dietary patterns on blood pressure . METHODS We enrolled 459 adults with systolic blood pressures of less than 160 mm Hg and diastolic blood pressures of 80 to 95 mm Hg . For three weeks , the subjects were fed a control diet that was low in fruits , vegetables , and dairy products , with a fat content typical of the average diet in the United States . They were then r and omly assigned to receive for eight weeks the control diet , a diet rich in fruits and vegetables , or a \" combination \" diet rich in fruits , vegetables , and low-fat dairy products and with reduced saturated and total fat . Sodium intake and body weight were maintained at constant levels . RESULTS At base line , the mean ( + /-SD ) systolic and diastolic blood pressures were 131.3+/-10.8 mm Hg and 84.7+/-4.7 mm Hg , respectively . The combination diet reduced systolic and diastolic blood pressure by 5.5 and 3.0 mm Hg more , respectively , than the control diet ( P systolic blood pressure by 2.8 mm Hg more ( P diastolic blood pressure by 1.1 mm Hg more than the control diet ( P=0.07 ) . Among the 133 subjects with hypertension ( systolic pressure , > or = 140 mm Hg ; diastolic pressure , > or = 90 mm Hg ; or both ) , the combination diet reduced systolic and diastolic blood pressure by 11.4 and 5.5 mm Hg more , respectively , than the control diet ( P 326 subjects without hypertension , the corresponding reductions were 3.5 mm Hg ( P blood pressure . This diet offers an additional nutritional approach to preventing and treating hypertension",
"Background We investigated whether macronutrient composition of energy-restricted diets influences the efficacy of a telemedically guided weight loss program . Methods Two hundred overweight subjects were r and omly assigned to a conventional low-fat diet and a low-carbohydrate diet group ( target carbohydrate content : > 55 % energy and weekly nutrition education program and dietary counselling by telephone , and had to transfer actual body weight data to our clinic weekly with added Bluetooth ® technology by mobile phone . Various fatness and fat distribution parameters , energy and macronutrient intake , and various biochemical risk markers were measured at baseline and after 6 , and 12 months . Results In both groups , energy intake decreased by 400 kcal/d compared to baseline values within the first 6 months and slightly increased again within the second 6 months . Macronutrient composition differed significantly between the groups from the beginning to month 12 . At study termination , weight loss was 5.8 kg ( SD : 6.1 kg ) in the low-carbohydrate group and 4.3 kg ( SD : 5.1 kg ) in the low-fat group ( p = 0.065 ) . In the low-carbohydrate group , triglyceride and HDL-cholesterol levels were lower at month 6 and waist circumference and systolic blood pressure were lower at month 12 compared with the low-fat group ( P = 0.005–0.037 ) . Other risk markers improved to a similar extent in both groups . Conclusion Despite favourable effects of both diets on weight loss , the carbohydrate-reduced diet was more beneficial with respect to cardiovascular risk factors compared to the fat-reduced diet . Nevertheless , compliance with a weight loss program appears to be even a more important factor for success in prevention and treatment of obesity than the composition of the diet . Trial registration Clinical trials.gov as",
"Objective Dietary carbohydrate is the major determinant of postpr and ial glucose levels , and several clinical studies have shown that low-carbohydrate diets improve glycemic control . In this study , we tested the hypothesis that a diet lower in carbohydrate would lead to greater improvement in glycemic control over a 24-week period in patients with obesity and type 2 diabetes mellitus . Research design and methods Eighty-four community volunteers with obesity and type 2 diabetes were r and omized to either a low-carbohydrate , ketogenic diet ( LCKD ) or a low-glycemic , reduced-calorie diet ( 500 kcal/day deficit from weight maintenance diet ; LGID ) . Both groups received group meetings , nutritional supplementation , and an exercise recommendation . The main outcome was glycemic control , measured by hemoglobin A1c . Results Forty-nine ( 58.3 % ) participants completed the study . Both interventions led to improvements in hemoglobin A1c , fasting glucose , fasting insulin , and weight loss . The LCKD group had greater improvements in hemoglobin A1c ( -1.5 % vs. -0.5 % , p = 0.03 ) , body weight ( -11.1 kg vs. -6.9 kg , p = 0.008 ) , and high density lipoprotein cholesterol ( + 5.6 mg/dL vs. 0 mg/dL , p Diabetes medications were reduced or eliminated in 95.2 % of LCKD vs. 62 % of LGID participants ( p Dietary modification led to improvements in glycemic control and medication reduction/elimination in motivated volunteers with type 2 diabetes . The diet lower in carbohydrate led to greater improvements in glycemic control , and more frequent medication reduction/elimination than the low glycemic index diet . Lifestyle modification using low carbohydrate interventions is effective for improving and reversing type 2 diabetes",
"BACKGROUND The effect of dietary composition on blood pressure is a subject of public health importance . We studied the effect of different levels of dietary sodium , in conjunction with the Dietary Approaches to Stop Hypertension ( DASH ) diet , which is rich in vegetables , fruits , and low-fat dairy products , in persons with and in those without hypertension . METHODS A total of 412 participants were r and omly assigned to eat either a control diet typical of intake in the United States or the DASH diet . Within the assigned diet , participants ate foods with high , intermediate , and low levels of sodium for 30 consecutive days each , in r and om order . RESULTS Reducing the sodium intake from the high to the intermediate level reduced the systolic blood pressure by 2.1 mm Hg ( P reductions of 4.6 mm Hg during the control diet ( P participants with and in those without hypertension , blacks and those of other races , and women and men . The DASH diet was associated with a significantly lower systolic blood pressure at each sodium level ; and the difference was greater with high sodium levels than with low ones . As compared with the control diet with a high sodium level , the DASH diet with a low sodium level led to a mean systolic blood pressure that was 7.1 mm Hg lower in participants without hypertension , and 11.5 mm Hg lower in participants with hypertension . CONCLUSIONS The reduction of sodium intake to levels below the current recommendation of 100 mmol per day and the DASH diet both lower blood pressure substantially , with greater effects in combination than singly . Long-term health benefits will depend on the ability of people to make long-lasting dietary changes and the increased availability of lower-sodium foods",
"OBJECTIVES A r and omized clinical trial was used to compare the effects of an angiotensin II type 1 receptor inhibitor , c and esartan , singly or in combination with a reducing sodium diet , the DASH diet , on the quality of life ( QOL ) in out patients with hypertension . METHODS After a 2-week wash out period with placebo , 102 patients with mild to moderate hypertension were r and omly assigned to receive c and esartan ( 8 to 16 mg per day ) , and 99 patients were assigned to follow the DASH diet in addition to the same dose of c and esartan , both for 16 weeks . Patients completed the Subjective Symptoms Assessment Profile question naire , just before treatment and at the end of treatment . ANOVA was used to analyze the QOL-score changes over time and compare treatments . RESULTS Resting blood pressures were significantly reduced by the combination of c and esartan and DASH diet ( p mental component scores after 16 weeks of treatment with the combination of c and esartan and DASH diet ( p of c and esartan maintains significant control of blood pressure and may improve QOL-scores , especially when combined with a reducing sodium diet",
"Aims /hypothesisThis study compared the long-term weight loss and health outcomes at 1-year follow-up , after a 12-week intensive intervention consisting of two low-fat , weight-loss diets , which differed in protein content . Methods We r and omly assigned 66 obese patients ( BMI : 27–40 kg/m2 ) with Type 2 diabetes to either a low-protein ( 15 % protein , 55 % carbohydrate ) or high-protein diet ( 30 % protein , 40 % carbohydrate ) for 8 weeks of energy restriction ( ~6.7 MJ/day ) and 4 weeks of energy balance . Subjects were asked to maintain the same dietary pattern for a further 12 months of follow-up . Results The study was completed by 38 of the subjects , with equal dropouts in each group . At Week 64 , weight reductions against baseline were −2.2±1.1 kg ( low protein ) and −3.7±1.0 kg ( high protein ) , p diet effect . Fat mass was not different from baseline in either group . At Week 12 , both diets reduced systolic and diastolic blood pressure by 6 and 3 mm Hg respectively , but blood pressure increased more with weight regain during follow-up in the low-protein group ( p≤0.04 ) . At Week 64 , both diets significantly increased HDL cholesterol and lowered C-reactive protein concentrations . There was no difference in the urinary urea : creatinine ratio at baseline between the two groups , but this ratio increased at Week 12 ( in the high-protein group only , p high-protein weight-reduction diet may in the long term have a more favourable cardiovascular risk profile than a low-protein diet with similar weight reduction in people with Type 2 diabetes",
"BACKGROUND Patients with high blood pressure ( BP ) often exhibit syndrome X , an aggregation of abnormalities in carbohydrate and lipoprotein metabolism associated with increased risk of coronary heart disease ( CHD ) . The present study evaluated the effects of a 6-month intervention involving either aerobic exercise training alone ( EX only ) or exercise combined with a structured weight loss program ( EX + WL ) on CHD risk factors associated with syndrome X. METHODS A total of 53 men and women were selected from a larger behavioral intervention trial , who showed the hyperinsulinemia , dyslipidemia , and high BP characteristic of syndrome X. Participants were r and omly assigned to EX only ( n = 21 ) , EX + WL ( n = 21 ) , or a waiting list control group ( n = 11 ) . Before and following treatment , participants underwent measurement of glucose tolerance , lipid levels , and clinical BP . RESULTS Hyperinsulinemic responses to glucose challenge were significantly reduced in both the EX + WL group ( P weight loss showed the most robust improvements in abnormal insulin responses ( EX + WL group , 47 % reduction ; EX-only group , 27 % reduction ) . Diastolic BP was significantly reduced in the EX + WL group ( 96 + /- 4 to 87 + /- 5 mm Hg [ mean + /- SD ] ; P = .01 ) , but not in the EX-only group ( 93 + /- 4 to 89 + /- 5 mm Hg [ mean + /- SD ] ; P = .08 ) . Lipid profile was not significantly improved by either intervention . CONCLUSION These results suggest that EX + WL is an effective treatment for hyperinsulinemia and lowering of diastolic BP in patients with the syndrome",
"In a recent communication , ' Poole has proposed that epidemiologists draw an occasional p-value function in order to help them avoid misinterpreting confidence intervals ( CIs ) . Such an exercise might well have some value , and certainly the p-value function does impart more information than a single CI . However , I doubt that such functions are appreciably less subject to misinterpretation than are CIs , and I take strong exception to the suggestion by Poole that my perspective on CIs2 leads to fallacious conclusions that would be averted by a consideration of p-value functions . Poole offers two examples of insights that might be provided by the plotting of p-value functions . First , he plots such functions for the two examples given in Figures 1 and 2 ofmy paper.2 From the plots he concludes that \" the two point estimates are virtually identical , but one estimate is much more precise than the other . \" ' Even the most cursory inspection of my figures would lead to exactly the same conclusion , and I would hope that even without benefit of a picture most readers are able to make similar sense out of reported point estimates and CIs of 2.3 ( 95 per cent CI = 0.4 - 17.3 ) versus 2.5 ( 95 per cent CI = 1.3 - 4.7 ) . The second of Poole 's examples concerns a study of spermicides and Down 's syndrome in which Rothman compared cases to each oftwo control groups.3 In that study , the odds ratio for the comparison between cases and r and om controls was 3.6 ( 90 per cent CI = 1.2 - 9.0 ) , as opposed to 2.8 ( 90 per cent CI = 0.9 - 7.3 ) for the comparison involving controls with congenital heart disease . Although Poole cl aims that the \" full utility \" of p-value functions comes when one result is compared with another , I fail to see how in this example inspection of such functions would provide any special insight . It is clear from examination of the point estimates themselves and from the considerable overlap of the CIs that comparison of the cases with the control group that would presumably be subject to a corresponding recall bias yields a result that is not strikingly different from that for the comparison with r and om controls . Consequently , it is difficult to agree with Mills , et al , who have cl aim ed that the results suggest \" that recall bias may have caused the higher rate of spermicide use reported in the Down 's group . 4 Poole maintains that an erroneous conclusion such as that of Mills , et al , follows \" almost to the letter \" my perspective on the interpretation of CIs . This cl aim is patently false . In fact , I warned explicitly against the very type of fallacious reasoning of which Mills , et al , were guilty . In my discussion of interaction,2 I described the pitfalls",
"OBJECTIVE To examine the effects of a high-carbohydrate low-fat ( HCLF ) and a modified-fat ( MF ) diet on body weight and metabolic control in subjects with non-insulin-dependent diabetes mellitus ( NIDDM ) living at home . RESEARCH DESIGN AND METHODS Twenty-four NIDDM patients followed HCLF and MF diets alternately and in r and om order for a 3-month period while at home , with a 1-month baseline and washout between diets . Before and after each diet , fasting glucose and lipids , HbAlc , blood pressure , and body weight were measured . Dietary preferences were assessed by question naire . RESULTS Subjects consumed 50 % of energy as carbohydrate and 23 % as fat on the HCLF diet and 40 % of energy as carbohydrate and 36 % as fat ( over half of which was monounsaturated fat ) on the MF diet . Subjects lost weight on both HCLF and MF diets ( mean loss 0.7 and 1.3 kg , respectively ) . Although the MF diet result ed in a small decrease in fasting glucose levels , there was no significant change in HbA1c . Similarly , there was no significant difference between the diets in changes in blood pressure or fasting blood lipids . Most subjects ( 65 % ) preferred the MF diet . CONCLUSIONS Although the MF diet is not a low-fat diet , it did not appear to facilitate weight gain in subjects with NIDDM living at home . The MF diet provides an alternative for individuals unable to comply with HCLF diets",
"BACKGROUND Although the DASH ( Dietary Approaches to Stop Hypertension ) diet has been shown to lower blood pressure ( BP ) in short-term feeding studies , it has not been shown to lower BP among free-living individuals , nor has it been shown to alter cardiovascular biomarkers of risk . OBJECTIVE To compare the DASH diet alone or combined with a weight management program with usual diet controls among participants with prehypertension or stage 1 hypertension ( systolic BP , 130 - 159 mm Hg ; or diastolic BP , 85 - 99 mm Hg ) . DESIGN AND SETTING R and omized , controlled trial in a tertiary care medical center with assessment s at baseline and 4 months . Enrollment began October 29 , 2003 , and ended July 28 , 2008 . PARTICIPANTS Overweight or obese , unmedicated out patients with high BP ( N = 144 ) . INTERVENTIONS Usual diet controls , DASH diet alone , and DASH diet plus weight management . OUTCOME MEASURES The main outcome measure is BP measured in the clinic and by ambulatory BP monitoring . Secondary outcomes included pulse wave velocity , flow-mediated dilation of the brachial artery , baroreflex sensitivity , and left ventricular mass . RESULTS Clinic-measured BP was reduced by 16.1/9.9 mm Hg ( DASH plus weight management ) ; 11.2/7.5 mm ( DASH alone ) ; and 3.4/3.8 mm ( usual diet controls ) ( P ambulatory BP ( P pulse wave velocity , baroreflex sensitivity , and left ventricular mass ( all P overweight or obese persons with above-normal BP , the addition of exercise and weight loss to the DASH diet result ed in even larger BP reductions , greater improvements in vascular and autonomic function , and reduced left ventricular mass . CLINICAL TRIAL REGISTRATION clinical trials.gov Identifier : NCT00571844",
"Although aerobic exercise training and diet-induced weight loss each have been shown to individually lower elevated blood pressure ( BP ) , it is currently not known whether their combined use produces an additive antihypertensive effect . In this r and omized clinical trial we therefore compared the effect on resting BP of exercise training only and dietary modification only with that of exercise training plus dietary modification in 55 sedentary , overweight patients with high normal BP or stage 1 or 2 hypertension . After baseline testing , patients were r and omized to 1 of the following 3 interventions for 12 weeks : exercise training only ( aerobic exercise ; 30 to 45 minutes ; 3 to 5 days/week ; 60 % to 85 % of maximal heart rate ) , dietary modification only ( aim ed primarily at weight loss via restriction of energy intake and dietary fat ) , or exercise training plus dietary modification . Forty-eight patients completed the study . In these patients , exercise training plus dietary modification elicited a greater reduction ( p body weight ( -7.1 + /- 2.9 vs -1.0 + /- 1.8 kg ) than exercise training only , and a greater increase ( p maximal oxygen uptake ( 4.3 + /- 2.6 vs 1.9 + /- 2.0 ml/kg/min ) versus dietary modification only . However , the reduction in BP with exercise training plus dietary modification ( -12.5 + /- 6.3/7.9 + /- 4.3 mm Hg ) did not differ significantly from that with exercise training only ( -9.9 + /- 6.4/5.9 + /- 4.6 mm Hg ) or dietary modification only ( -11.3 + /- 12.1/7.5 + /- 4.3 mm Hg ) . These data indicate that the antihypertensive effects of exercise training and diet-induced weight loss are not additive . This finding has important public health and clinical implication s for the millions of overweight persons with high normal BP or stage 1 or 2 hypertension ",
"OBJECTIVE --To determine the effect of moderate dietary sodium restriction on the hypertension of non-insulin-dependent ( type II ) diabetes . DESIGN --R and omised parallel controlled study of moderate sodium restriction for three months compared with usual diabetic diet , followed by r and omised double blind crossover trial of sustained release preparation of sodium for one month versus placebo for one month in patients continuing with sodium restriction . SETTING -- Patients attending diabetic outpatient clinic of city hospital . PATIENTS --Thirty four patients with established type II diabetes complicated by mild hypertension ( systolic blood pressure greater than 160 mm Hg or diastolic pressure greater than 95 mm Hg on three consecutive occasions ) . Patients already taking antihypertensive agents ( but not diuretics ) not barred from study provided that criteria for mild hypertension still met . Conditions precluding patients from study were diabetic or hypertensive nephropathy , cardiac failure , and pregnancy . INTERVENTIONS --After run in phase with recordings at seven weeks , three weeks , and time zero patients were allocated at r and om to receive moderate dietary sodium restriction for three months ( n = 17 ) or to continue with usual diabetic diet . Subsequently nine patients in sodium restriction group continued with regimen for a further two months , during which they completed a r and omised double blind crossover trial of sustained release preparation of sodium ( Slow Sodium 80 mmol daily ) for one month versus matching placebo for one month . END POINT -- Reduction in blood pressure in type II diabetics with mild hypertension . MEASUREMENTS AND MAIN RESULTS --Supine and erect blood pressure , body weight , and 24 hour urinary sodium and potassium excretion measured monthly during parallel group and double blind crossover studies . After parallel group study sodium restriction group showed significant reduction in systolic blood pressure ( supine 19.2 mm Hg , erect 21.4 mm Hg ; p less than 0.001 ) and mean daily urinary sodium excretion ( mean reduction 60 mmol/24 h ) . There were no appreciable changes in weight , diabetic control , or diastolic pressure . No significant changes occurred in controls . In double blind crossover study mean supine systolic blood pressure rose significantly ( p less than 0.005 ) during sodium supplementation ( to 171 mm Hg ) compared with value after three months of sodium restriction alone ( 159.9 mm Hg ) and after one month of placebo ( 161.8 mm Hg ) . CONCLUSIONS --Moderate dietary restriction of sodium has a definite hypotensive effect , which may be useful in mild hypertension of type II diabetes",
"BACKGROUND For many people , maintenance of weight loss is elusive . Whereas high-protein ( HP ) diets have been found to be superior to high-carbohydrate ( HC ) diets for weight loss in the short term , their benefits long term are unclear , particularly for weight maintenance . Furthermore , the literature lacks consensus on the long-term effects of an HP diet on cardiovascular disease risk factors . OBJECTIVE The objective was to investigate whether macronutrient dietary composition plays a role in weight maintenance and in improvement of cardiovascular disease risk factors . DESIGN The study comprised 2 phases . Phase 1 featured a very-low-energy diet for 3 mo . In phase 2 , the subjects were r and omly assigned to an HP or an HC diet for 12 mo . The diets were isocaloric , tightly controlled , and individually prescribed for weight maintenance . The subjects were overweight or obese but otherwise healthy men and women . RESULTS The subjects lost an average of 16.5 kg during phase 1 and maintained a mean ( + /-SEM ) weight loss of 14.5 + /- 1.2 kg ( P systolic blood pressure were 14.3 + /- 2.4 mm Hg for the HP group and 7.7 + /- 2.2 mm Hg for the HC group ( P . Forty-seven percent of the 180 subjects who began the study completed both phases . CONCLUSIONS The results indicate that the protein or carbohydrate content of the diet has no effect on successful weight-loss maintenance . A general linear model analysis indicated that dietary treatment ( HP or HC ) was a significant factor in systolic blood pressure change and in favor of the HP diet . This trial was registered at www . clinical trials.gov as NCT 00625236",
"OBJECTIVE We compared the effects of a low glycemic index ( GI ) diet with the American Diabetes Association ( ADA ) diet on glycosylated hemoglobin ( HbA1c ) among individuals with type 2 diabetes . METHODS Forty individuals with poorly controlled type 2 diabetes were r and omized to a low-GI or an ADA diet . The intervention , consisting of eight educational sessions ( monthly for the first 6 mo and then at months 8 and 10 ) , focused on a low-GI or an ADA diet . Data on demographics , diet , physical activity , psychosocial factors , and diabetes medication use were assessed at baseline and 6 and 12 mo . Generalized linear mixed models were used to compare the two groups on HbA1c , diabetic medication use , blood lipids , weight , diet , and physical activity . RESULTS Participants ( 53 % female , mean age 53.5 y ) were predominantly white with a mean body mass index of 35.8 kg/m(2 ) . Although both interventions achieved similar reductions in mean HbA1c at 6 mo and 12 mo , the low-GI diet group was less likely to add or increase dosage of diabetic medications ( odds ratio 0.26 , P = 0.01 ) . Improvements in high-density lipoprotein cholesterol , triacylglycerols , and weight loss were similar between groups . CONCLUSION Compared with the ADA diet , the low-GI diet achieved equivalent control of HbA1c using less diabetic medication . Despite its limited size , this trial suggests that a low-GI diet is a viable alternative to the ADA diet . Findings should be evaluated in a larger r and omized controlled trial",
"Two-hundred- and -twelve untreated subjects ( mean age 52.3 + /- 0.8 years ; 181 males and 31 females ) with a diastolic blood pressure between 90 and 100 mmHg were recruited to the study . Subjects were seen fortnightly and , after 4 pre-diet visits , were r and omized into a normal diet group ( A , 55 subjects ) , a high-potassium diet group ( B , 52 subjects receiving greater than 100 mmol K+/day ) a reduced-sodium diet group ( C , 52 subjects receiving 50 - 75 mmol Na+/day ) or a high-potassium and low-sodium diet group ( D , 53 subjects receiving same Na+ and K+ as groups B and C ) . Two-hundred subjects completed the diet phase of 12 weeks . Urine sodium fell to 86 + /- 7 mmol/day in group C and 73 + /- 6 mmol/day in group D , while daily potassium excretion rose to 96 + /- 5 mmol in group B and 87 + /- 4 mmol in group C. Systolic and diastolic blood pressure fell by 3.8 + /- 1.0 and 1.6 + /- 0.6 mmHg respectively in the normal diet group . The falls in systolic and diastolic blood pressures ( mmHg ) in the diet phase were 7.7 + /- 1.1 and 4.7 + /- 0.7 ( B ) , 8.9 + /- 1.0 and 5.8 + /- 0.6 ( C ) and 7.9 + /- 0.9 and 4.2 + /- 0.7 ( D ) . These falls were all greater than those in the control group on an intention-to-treat analysis ( P less than 0.005 ) but did not differ from each other . Factorial analysis confirmed that the falls in pressure attributable to the low-sodium diet and high-potassium diet were not additive . ( ABSTRACT TRUNCATED AT 250 WORDS",
"OBJECTIVE To provide a firmer basis for preventing high blood pressure ( BP ) , we tested interventions to promote weight loss , dietary sodium reduction , and their combination for lowering diastolic BP , systolic BP , and the incidence of hypertension during a 3- to 4-year period . METHODS We conducted a r and omized , 2 x 2 factorial , clinical trial , with BP levels measured by blinded observers . Nine academic medical centers recruited 2382 men and women ( age range , 30 - 54 years ) not taking antihypertensive drugs , with a diastolic BP of 83 to 89 mm Hg , a systolic BP lower than 140 mm Hg , and a body mass index ( the weight in kilograms divided by the square of the height in meters ) representing 110 % to 165 % of desirable body weight . Counseling aim ed at helping participants achieve their desirable weight or a 4.5-kg or more weight reduction ( in the weight loss and combined groups ) and /or sodium intake of 80 mmol/d ( in the sodium reduction and combined groups ) was provided . RESULTS From baseline , participants ' weight decreased by 4.3 to 4.5 kg at 6 months and by approximately 2 kg at 36 months in the weight loss and combined groups compared with weight changes in the usual care group ( all groups , P Sodium excretion decreased 50 and 40 mmol/d at 6 and 36 months , respectively , in the sodium reduction group and about 15 mmol/d less at each time point in the combined group compared with the usual care group ( all groups , P care group , BP decreased 3.7/2.7 mm Hg in the weight loss group , 2.9/1.6 mm Hg in the sodium reduction group , and 4.0/2.8 mm Hg in the combined group at 6 months ( all groups , P BP decreases remained greater in the active intervention groups than in the usual care group ( weight loss group , 1.3/0.9 mm Hg ; sodium reduction group , 1.2/0.7 mm Hg ; combined group , 1.1/0.6 mm Hg ) . Differences were statistically significant for systolic and diastolic BP in the weight loss group and for systolic BP in the sodium reduction group . Through 48 months , the incidence of hypertension ( BP > or = 140 mm Hg systolic or > or = 90 mm Hg diastolic or the use of antihypertensive drugs ) was significantly less in each active intervention group than the usual care group ( average relative risks , 0.78 - 0.82 ) . CONCLUSIONS In overweight adults with high-normal BP , weight loss and reduction in sodium intake , individually and in combination , were effective in lowering systolic and diastolic BP , especially in the short-term ( 6 months ) . Although the effects on average BP declined over time , reductions in hypertension incidence were achieved",
"OBJECTIVE To investigate whether glycemic and lipid control in patients with non-insulin-dependent diabetes ( NIDDM ) can be significantly improved using a low-fat , vegetarian ( vegan ) diet in the absence of recommendations regarding exercise or other lifestyle changes . METHODS Eleven subjects with NIDDM recruited from the Georgetown University Medical Center or the local community were r and omly assigned to a low-fat vegan diet ( seven subjects ) or a conventional low-fat diet ( four subjects ) . Two additional subjects assigned to the control group failed to complete the study . The diets were not design ed to be isocaloric . Fasting serum glucose , body weight , medication use , and blood pressure were assessed at baseline and biweekly thereafter for 12 weeks . Serum lipids , glycosylated hemoglobin , urinary albumin , and dietary macronutrients were assessed at baseline and 12 weeks . RESULTS Although the sample was intentionally small in accordance with the pilot study design , the 28 % mean reduction in fasting serum glucose of the experimental group , from 10.7 to 7.75 mmol/L ( 195 to 141 mg/dl ) , was significantly greater than the 12 % decrease , from 9.86 to 8.64 mmol/L ( 179 to 157 mg/dl ) , for the control group ( P mean weight loss was 7.2 kg in the experimental group , compared to 3 . 8 kg for the control group ( P Insulin was reduced in both experimental group patients on insulin . No patient in the control group reduced medication use . Differences between the diet groups in the reductions of serum cholesterol and 24-h microalbuminuria did not reach statistical significance ; however , high-density lipoprotein concentration fell more sharply ( 0.20 mmol/L ) in the experimental group than in the control group ( 0.02 mmol/L ) ( P low-fat , vegetarian diet in patients with NIDDM was associated with significant reductions in fasting serum glucose concentration and body weight in the absence of recommendations for exercise . A larger study is needed for confirmation",
"The present study set out to assess the feasibility of long-term moderate dietary sodium restriction in patients with mild hypertension in general practice . After screening and a run-in phase of 6 - 8 weeks , a total of 77 previously undiagnosed mildly hypertensive patients were identified . Half of them were r and omized to receive a few simple dietary instructions from their general practitioners in order to reduce salt usage ; the others were r and omized to receive no advice . The patients were followed up for 12 months with quarterly visits . A total of 56 patients ( 72.7 % ) completed the study , 26 on a low-sodium diet ( LD ) and 30 on their usual diet ( UD ) . At each visit in the diet phase , patients provided 24h urine , which was analysed for volume and sodium concentration in order to assess their sodium intake . Blood pressure , heart the rate and body weight were recorded . The mean urinary sodium excretion for all diet phase visits overlapped in the two groups ( 177.0 + /- 32.9 vs. 169.3 + /- 49.4 mEq/24h respectively in the LD and UD groups ) . Nevertheless the mean systolic and diastolic blood pressures for all diet phase visits were significantly lower in the LD than in UD group ( 144.2 + /- 11.1/91.6 + /- 6.4 and 148.0 + /- 13.7/95.6 + /- 4.7 mmHg respectively , P less than 0.01 ) . Our data suggest that it is not feasible at present to reduce sodium intake in mild hypertensives with simple and inexpensive dietary instructions , the only ones suitable for widespread application in general practice",
"OBJECTIVE To determine the optimal diet for improving glucose and lipid profiles in obese patients with type 2 diabetes during moderate energy restriction . RESEARCH DESIGN AND METHODS A total of 35 free-living obese patients with type 2 diabetes were assigned to one of three 1,600 kcal/day diets for 12 weeks . The diets were high carbohydrate ( 10 % fat , 4 % saturated ) , high monounsaturated fat ( MUFA ) ( 32 % fat , 7 % saturated ) , or high saturated fat ( SFA ) ( 32 % fat , 17 % saturated ) . RESULTS Diet composition did not affect the magnitude of weight loss , with subjects losing an average of 6.6 + /- 0.9 kg . Energy restriction and weight loss result ed in reductions in fasting plasma glucose ( -14 % ) , insulin ( -27 % ) , GHb ( -14 % ) , and systolic ( -7 % ) and diastolic blood pressure ( -10 % ) levels and the glucose response area ( -17 % ) independent of diet composition . Diet composition did affect the lipoprotein profile . LDL was 10 % and 17 % lower with the high-carbohydrate and high-MUFA diets , respectively , whereas no change was observed with the high-SFA diet ( P HDL was transiently reduced on the high-carbohydrate diet at weeks 1 , 4 , and 8 , whereas higher fat consumption maintained these levels . The total cholesterol : HDL ratio , although significantly reduced on the high-MUFA diet ( P glycemic control ; however , reducing SFA intake by replacing SFA with carbohydrate or MUFA reduces LDL maximally during weight loss and to a greater degree than has been shown in weight-stable studies",
"CONTEXT Nonpharmacologic interventions are frequently recommended for treatment of hypertension in the elderly , but there is a paucity of evidence from r and omized controlled trials in support of this recommendation . OBJECTIVE To determine whether weight loss or reduced sodium intake is effective in the treatment of older persons with hypertension . DESIGN R and omized controlled trial . PARTICIPANTS A total of 975 [ corrected ] men and women aged 60 to 80 years with systolic blood pressure lower than 145 mm Hg and diastolic blood pressure lower than 85 mm Hg while receiving treatment with a single antihypertensive medication . SETTING Four academic health centers . INTERVENTION The 585 obese participants were r and omized to reduced sodium intake , weight loss , both , or usual care , and the 390 nonobese participants were r and omized to reduced sodium intake or usual care . Withdrawal of antihypertensive medication was attempted after 3 months of intervention . MAIN OUTCOME MEASURE Diagnosis of high blood pressure at 1 or more follow-up visits , or treatment with antihypertensive medication , or a cardiovascular event during follow-up ( range , 15 - 36 months ; median , 29 months ) . RESULTS The combined outcome measure was less frequent among those assigned vs not assigned to reduced sodium intake ( relative hazard ratio , 0.69 ; 95 % confidence interval [ CI ] , 0.59 - 0.81 ; P hazard ratios among the obese participants were 0.60 ( 95 % CI , 0.45 - 0.80 ; P reduced sodium intake alone , 0.64 ( 95 % CI , 0.49 - 0.85 ; P=.002 ) for weight loss alone , and 0.47 ( 95 % CI , 0.35 - 0.64 ; P reduced sodium intake and weight loss combined . The frequency of cardiovascular events during follow-up was similar in each of the 6 treatment groups . CONCLUSION Reduced sodium intake and weight loss constitute a feasible , effective , and safe nonpharmacologic therapy of hypertension in older persons ",
"OBJECTIVE This study sought to examine the effects of a 3-month programme of dietary advice to restrict carbohydrate intake compared with reduced-portion , low-fat advice in obese subjects with poorly controlled Type 2 diabetes . RESEARCH DESIGN AND METHODS One hundred and two patients with Type 2 diabetes were recruited across three centres and r and omly allocated to receive group education and individual dietary advice . Weight , glycaemic control , lipids and blood pressure were assessed at baseline and 3 months . Dietary quality was assessed at the end of study . RESULTS Weight loss was greater in the low-carbohydrate ( LC ) group ( -3.55 + /- 0.63 , mean + /- sem ) vs. -0.92 + /- 0.40 kg , P = 0.001 ) and cholesterol : high-density lipoprotein ( HDL ) ratio improved ( -0.48 + /- 0.11 vs. -0.10 + /- 0.10 , P = 0.01 ) . However , relative saturated fat intake was greater ( 13.9 + /- 0.71 vs. 11.0 + /- 0.47 % of dietary intake , P short-term weight loss compared with st and ard advice , but this was at the expense of an increase in relative saturated fat intake",
"BACKGROUND Some cross-sectional studies suggest that fiber and protein intake can be associated with lower levels of blood pressure , but results from prospect i ve cohorts are scarce and none has been conducted outside the U.S. METHODS The SUN cohort followed-up prospect ively 5880 Spanish men and women older than 20 years of age , all university graduates . Dietary information was gathered at baseline with a previously vali date d semiquantitative food frequency question naire . New cases of medically diagnosed hypertension ( HT ) were identified through responses to a mailed question naire after at least 2 years from recruitment . RESULTS One hundred and eighty new cases of HT were ascertained after a median follow-up of 28 months . After adjustment for potential confounders and several dietary factors , participants in the highest quintile of vegetable protein intake had a lower risk of incident HT compared with those in the lowest quintile [ hazard ratio ( HR ) = 0.5 , 95 % confidence interval ( CI ) 0.2 - 0.9 , p for trend = 0.06 ] . Similarly , fiber from cereals was inversely associated with a lower risk of HT ( HR comparing fifth vs. first quintile = 0.6 , 95 % CI 0.3 - 1.0 , p for trend = 0.05 ) . Risk reduction was more important among men and obese and older individuals . Total or animal protein and total fiber as well as fiber from other sources different from cereal were not associated with the risk of HT . CONCLUSIONS In this Mediterranean cohort , dietary intake of vegetable protein and fiber from cereals was associated with a lower risk of HT when other nutrients were also taken into consideration",
"Background / Objectives : Short-term studies have suggested beneficial effects of a Palaeolithic-type diet ( PD ) on body weight and metabolic balance . We now report the long-term effects of a PD on anthropometric measurements and metabolic balance in obese postmenopausal women , in comparison with a diet according to the Nordic Nutrition Recommendations (NNR).Subjects/ Methods : Seventy obese postmenopausal women ( mean age 60 years , body mass index 33 kg/m2 ) were assigned to an ad libitum PD or NNR diet in a 2-year r and omized controlled trial . The primary outcome was change in fat mass as measured by dual-energy X-ray absorptiometry . Results : Both groups significantly decreased total fat mass at 6 months ( −6.5 and −2.6 kg ) and 24 months ( −4.6 and −2.9 kg ) , with a more pronounced fat loss in the PD group at 6 months ( P ) . Waist circumference and sagittal diameter also decreased in both the groups , with a more pronounced decrease in the PD group at 6 months ( −11.1 vs−5.8 cm , P=0.001 and −3.7 vs−2.0 cm , P respectively ) . Triglyceride levels decreased significantly more at 6 and 24 months in the PD group than in the NNR group ( P P=0.004 ) . Nitrogen excretion did not differ between the groups . Conclusions : A PD has greater beneficial effects vs an NNR diet regarding fat mass , abdominal obesity and triglyceride levels in obese postmenopausal women ; effects not sustained for anthropometric measurements at 24 months . Adherence to protein intake was poor in the PD group . The long-term consequences of these changes remain to be studied",
"1 . Three groups of young patients with borderline hypertension were studied for a 12 months period . The first was on a free sodium diet while the second was on a low-salt diet . The third group of patients underwent acute salt loading . 2 . After 12 months the group on free diet showed a significant increase of intralymphocytic sodium but no change in blood pressure was noted . Five patients who were re-checked after 24 months also had a significant increase in blood pressure . 3 . Patients treated with a low-salt diet showed a significant decrease of both intralymphocytic sodium concentration and blood pressure . 4 . After acute salt loading , borderline subjects with high intralymphocytic sodium showed a significant greater natriuresis whereas intralymphocytic sodium increased only in those subjects in whom it was initially normal",
"Ninety four patients with mild hypertension ( average supine diastolic blood pressure ( phase V ) 95 - 110 mm Hg ) were allocated at r and om to receive restriction of dietary sodium ( maximum allowed 70 mmol(mEq)/24 h ) or a normal diet . In addition , they received in r and om order 25 mg chlorthalidone , 200 mg metoprolol ( slow release ) , and a fixed combination of these two drugs . Each drug treatment was given for four weeks and alternated with four weeks of placebo . Forty four patients were allocated to sodium restriction ( group 1 ) and 50 to normal diet ( group 2 ) . The mean 24 hour urinary sodium excretion in group 1 was 74 ( SD 31 ) mmol(mEq)/24 h , and in group 2 132 ( 51 ) mmol/24 h. Compared with the screening blood pressure the average decrement of the supine blood pressure in group 1 was 16.0/8.6 mm Hg with placebo , 21.7/11.5 mm Hg with the diuretic , 28.5/17.8 mm Hg with the beta blocker , and 28.9/18.4 mm Hg with the combined agent ; in group 2 these values were 13.3/6.1 , 20.3/9.7 , 21.3/12.9 , and 29.4/16.8 mm Hg , respectively . There was a sharp decrease of the average potassium concentration during chlorthalidone and combination treatment periods ( average value 3.3 mmol(mEq)/1 ) . These results suggest that moderate salt restriction used as sole treatment has a limited though demonstrable blood pressure lowering effect but that when it is used as an adjuvant to beta blocker treatment its value is greatly enhanced",
"CONTEXT Weight loss , sodium reduction , increased physical activity , and limited alcohol intake are established recommendations that reduce blood pressure ( BP ) . The Dietary Approaches to Stop Hypertension ( DASH ) diet also lowers BP . To date , no trial has evaluated the effects of simultaneously implementing these lifestyle recommendations . OBJECTIVE To determine the effect on BP of 2 multicomponent , behavioral interventions . DESIGN , SETTING , AND PARTICIPANTS R and omized trial with enrollment at 4 clinical centers ( January 2000-June 2001 ) among 810 adults ( mean [ SD ] age , 50 [ 8.9 ] years ; 62 % women ; 34 % African American ) with above-optimal BP , including stage 1 hypertension ( 120 - 159 mm Hg systolic and 80 - 95 mm Hg diastolic ) , and who were not taking antihypertensive medications . INTERVENTION Participants were r and omized to one of 3 intervention groups : ( 1 ) \" established , \" a behavioral intervention that implemented established recommendations ( n = 268 ) ; ( 2 ) \" established plus DASH,\"which also implemented the DASH diet ( n = 269 ) ; and ( 3 ) an \" advice only \" comparison group ( n = 273 ) . MAIN OUTCOME MEASURES Blood pressure measurement and hypertension status at 6 months . RESULTS Both behavioral interventions significantly reduced weight , improved fitness , and lowered sodium intake . The established plus DASH intervention also increased fruit , vegetable , and dairy intake . Across the groups , gradients in BP and hypertensive status were evident . After subtracting change in advice only , the mean net reduction in systolic BP was 3.7 mm Hg ( P systolic BP difference between the established and established plus DASH groups was 0.6 mm Hg ( P = .43 ) . Compared with the baseline hypertension prevalence of 38 % , the prevalence at 6 months was 26 % in the advice only group , 17 % in the established group ( P = .01 compared with the advice only group ) , and 12 % in the established plus DASH group ( P optimal BP ( plus DASH group ( P Individuals with above-optimal BP , including stage 1 hypertension , can make multiple lifestyle changes that lower BP and reduce their cardiovascular disease risk",
"The purpose of this study was to investigate the effect of 1-year diet intervention , exercise intervention and both combined on blood pressure ( BP ) in normotensives and mild hypertensives . Two hundred and nineteen sedentary middle aged men and women with slightly deranged coronary heart disease ( CHD ) risk factors were r and omised to a control , a diet , an exercise and a diet + exercise group . Based on baseline diastolic BP , participants were divided into tertiles , giving baseline average BP of 141.4/96.7 in tertile 1 , 130.7/87.6 in tertile 2 and 121.9/79.0 in tertile 3 . The 1-year net-difference in BP between the intervention groups and the control group decreased across the tertiles ; in tertile 1 being -11.2/-6.7 ( p systolic BP only ) and -7.0/-5.1 ( NS ) in the combined , diet and exercise group respectively . Triglycerides , HDL cholesterol , and insulin variables were significantly and favourably changed , the changes being most marked in the combined group . The results show that diet and diet + exercise are about equally effective in reducing BP , and the effects may be dependent on the baseline level . Within the upper tertile of baseline BP , the decline in BP in the combined intervention and the diet group are almost comparable to those obtained with drug treatment . In addition , other important CHD risk factors were all changed in a beneficial direction",
"Objective To determine the extent to which intensive dietary intervention can influence glycaemic control and risk factors for cardiovascular disease in patients with type 2 diabetes who are hyperglycaemic despite optimised drug treatment . Design R and omised controlled trial . Setting Dunedin , New Zeal and . Participants 93 participants aged less than 70 years with type 2 diabetes and a glycated haemoglobin ( HbA1c ) of more than 7 % despite optimised drug treatments plus at least two of overweight or obesity , hypertension , and dyslipidaemia . Intervention Intensive individualised dietary advice ( according to the nutritional recommendations of the European Association for the Study of Diabetes ) for six months ; both the intervention and control participants continued with their usual medical surveillance . Main outcome measures HbA1c was the primary outcome . Secondary outcomes included measures of adiposity , blood pressure , and lipid profile . Results After adjustment for age , sex , and baseline measurements , the difference in HbA1c between the intervention and control groups at six months ( −0.4 % , 95 % confidence interval −0.7 % to −0.1 % ) was highly statistically significant ( P=0.007 ) , as were the decreases in weight ( −1.3 kg , −2.4 to −0.1 kg ; P=0.032 ) , body mass index ( −0.5 , −0.9 to −0.1 ; P=0.026 ) , and waist circumference ( −1.6 cm , −2.7 to −0.5 cm ; P=0.005 ) . A decrease in saturated fat ( −1.9 % total energy , −3.3 % to −0.6 % ; P=0.006 ) and an increase in protein ( 1.6 % total energy , 0.04 % to 3.1 % ; P=0.045 ) in the intervention group were the most striking differences in nutritional intake between the two groups . Conclusions Intensive dietary advice has the potential to appreciably improve glycaemic control and anthropometric measures in patients with type 2 diabetes and unsatisfactory HbA1c despite optimised hypoglycaemic drug treatment . Trial registration Clinical trials NCT00124553",
"Context Can adults make sustained changes in unhealthy lifestyle behaviors ? Content In this multicenter trial , 810 adult volunteers with prehypertension or stage 1 hypertension were r and omly assigned to a multicomponent behavioral intervention group , a group combining the behavioral intervention plus the Dietary Approaches to Stop Hypertension ( DASH ) diet , or an advice only group . At 18 months , participants in both behavioral intervention groups had less hypertension , more weight loss , and better reduction in sodium and fat intake than those receiving advice only . The participants in the DASH diet group also increased their intake of fruits , vegetables , and fiber . Implication s Motivated adults can sustain several lifestyle changes over 18 months , which might reduce their risk for cardiovascular disease . The Editors The public health burden of chronic diseases related to suboptimal diet and physical inactivity is enormous . It has been estimated that these lifestyle factors contribute to approximately 20 % of deaths in the United States ( 1 ) . Incidence of atherosclerotic cardiovascular disease , overweight and obesity , elevated blood pressure and lipid levels , diabetes , osteoporosis , and cancer is increased by unhealthy lifestyles ( 2 - 8 ) . Multiple lifestyle factors , such as physical inactivity ; excessive intake of calories , sodium , saturated fat , and cholesterol ; and inadequate intake of fruits , vegetables , and low-fat dairy products , are etiologically related to the development of these diseases ( 4 , 5 , 8 - 10 ) . To reduce the burden of chronic disease , increased physical activity and changes in diet are needed , yet few intervention studies have attempted to achieve many lifestyle changes simultaneously . The PREMIER r and omized trial tested the effects of 2 multicomponent behavioral interventions on blood pressure ( 11 ) . Both interventions promoted increased physical activity , weight loss , and reduced sodium intake , each of which is recommended by the 2005 Dietary Guidelines Scientific Advisory Committee ( 12 ) . One intervention also added the Dietary Approaches to Stop Hypertension ( DASH ) diet ( 13 ) . This diet , which is high in fruits , vegetables , and low-fat dairy products and low in saturated fat , total fat , and cholesterol , meets each of the major nutrient recommendations that were established by the Institute of Medicine ( 14 - 18 ) . We report the effects of the PREMIER interventions on lifestyle changes and blood pressure status at 18 months . The main results of PREMIER , namely change in blood pressure at 6 months , were reported previously ( 11 ) . Methods The PREMIER study design and rationale ( 19 ) and intervention methods ( 11 ) have been described previously . The institutional review boards at each clinical center ; an external protocol review committee appointed by the National Heart , Lung , and Blood Institute ( NHLBI ) ; and the NHLBI review ed and approved the protocol ( available at www.kpchr.org/public/premier/intervention/default.asp ) . The NHLBI also appointed a data and safety monitoring board to monitor the trial . Each participant provided written informed consent . The trial was conducted from January 2000 through November 2002 . Study Participants Participants were generally healthy adults , age 25 years or older , who had prehypertension or stage 1 hypertension and met the Joint National Committee VI ( JNC VI ) criteria for a 6-month trial of nonpharmacologic therapy ( 2 ) . Targeted recruitment methods were used to ensure adequate representation of clinical ly important subgroups , in particular , African-American persons . Specific methods varied from site to site but included direct mailings , radio and newspaper advertisements , and networking within the local African-American communities . Eligibility criteria included not taking antihypertensive medication and having a systolic blood pressure of 120 to 159 mm Hg and a diastolic blood pressure of 80 to 95 mm Hg , based on the average of 3 screening visits . Persons with prehypertension ( systolic blood pressure of 120 to 139 mm Hg or diastolic blood pressure of 80 to 89 mm Hg ) were included because of the excess risk for cardiovascular disease in those with blood pressure within this range ( 20 ) . Major exclusion criteria were a body mass index less than 18.5 kg/mg2 or greater than 45.0 kg/m2 , use of antihypertensive drugs or other drugs that affect blood pressure , JNC VI risk category C ( target organ damage or diabetes ) , use of prescription weight loss medications , previous cardiovascular event , congestive heart failure , angina , cancer , and consumption of more than 21 alcoholic drinks per week . Trial Conduct Eligible participants were r and omly assigned , with equal probability , to 1 of 3 groups : an advice only comparison group ( advice only ) ; an intervention group that targeted established , guideline -recommended lifestyle recommendations ( established ) ( 2 ) ; or an intervention group targeting the established recommendations and adding the DASH dietary pattern ( established plus DASH ) ( 13 ) . Computer-generated treatment assignments were stratified by clinic and hypertension status and were assigned in blocks of varying sizes to provide balance over time . The actual assignments were administered by using a password-protected , Web-based application developed by the coordinating center and accessible only by authorized individuals . All clinic measurement staff were blinded to treatment assignment , and all intervention staff were blinded to clinic measurements . Hypertension was defined by using the JNC VI criteria for hypertension treatment : an average systolic blood pressure of 140 mm Hg , a diastolic blood pressure greater than 90 mm Hg , or use of antihypertensive medication . Normal blood pressure was defined as systolic blood pressure less than 120 mm Hg , diastolic blood pressure less than 80 mm Hg , and no use of antihypertensive medication ( 21 ) ( Figure ) . Intervention was provided by master 's degreelevel counselors ( dietitians and health educators trained in behavioral methods ) . The counselors were central ly trained before the start of the study , attended annual 3-day training sessions , and participated in monthly conference calls . Figure . Flow diagram of enrollment , measurements , and visit completion . Advice Only Group Participants in the advice group received advice to follow the National High Blood Pressure Education Program lifestyle recommendations for blood pressure control ( 2 ) . Lifestyle recommendations included reducing weight ( if overweight ) , following a reduced-sodium diet , engaging in regular moderate-intensity physical activity , and eating a heart-healthy diet , including the DASH diet . This advice was provided in two 30-minute individual sessions , 1 immediately after r and om assignment and 1 after the 6-month data collection visit . A PREMIER counselor review ed the guidelines with the participant and provided printed educational material s and information about community re sources . This intervention did not include advice to keep a food or exercise diary . Behavioral Interventions in the Established and Established plus DASH Groups Participant goals for the established and established plus DASH groups included weight loss of at least 6.8 kg ( 15 lb ) for those with a body mass index of 25 kg/m2 or greater , at least 180 minutes per week of moderate-intensity physical activity , no more than 100 mmol per day of dietary sodium , and alcohol consumption of no more than 30 mL ( 1 oz ) per day ( 2 drinks ) for men and 15 mL ( 0.5 ) oz per day ( 1 drink ) for women . Participants assigned to the established plus DASH group ( but not those in the established group ) also received counseling on the DASH diet , with goals for increased consumption of fruits and vegetables ( 9 to 12 servings/d ) and low-fat dairy products ( 2 to 3 servings/d ) and reduced consumption of saturated fat ( 7 % of energy ) and total fat ( 25 % of energy ) . The intervention format , contact pattern , and behavior change strategies for the established and established plus DASH groups were identical . During the first 6 months , participants in both behavioral intervention groups attended 14 group sessions and 4 individual sessions ; during months 7 to 18 , they attended monthly group sessions supplemented with 3 individual counseling sessions . Throughout the trial , participants in the established and established plus DASH groups ( but not those in the advice group ) kept food diaries , monitored dietary calorie and sodium intakes , and recorded minutes of physical activity . Self-monitoring was used to provide individualized feedback , reinforcement , problem solving , and support . Social support for initial behavior changes and maintenance of change was provided during the group sessions . More detailed descriptions of the behavorial intervention methods are available ( 22 ) . Measurements Blood pressure was assessed twice at each measurement , and systolic and diastolic blood pressures were calculated by using the mean of all available measurements ( 4 sets before r and om assignment , 3 sets at 6 and 18 months , and 1 set at 3 and 12 months ) . For 4 participants who were started on antihypertensive drug therapy between the 12- and 18-month visits , we obtained an official set of blood pressure measurements before initiation of therapy and used these as our 18-month blood pressure values for analysis . A similar procedure was used to obtain the 6-month blood pressure value for the 1 participant who began taking antihypertensive drugs between the 3- and 6-month visits . Two 24-hour dietary recalls , 1 obtained on a weekday and the other obtained on a weekend , were collected at baseline and at 6 and 18 months by telephone interview ( 23 ) . Intakes of nutrients and food groups were calculated by using the Nutrition Data System for Research , version NDS-R 1998 ( University of Minnesota , Minneapolis , Minnesota ) . Urinary excretion of sodium ( reflecting salt intake ) and potassium ( reflecting fruit and vegetable intake ) was obtained from 24-hour urinary collection s at baseline",
"Low-carbohydrate diets have been associated with significant reductions in weight and HbA(1c ) in obese , diabetic participants who received high-intensity lifestyle modification for 6 or 12 months . This investigation sought to determine whether comparable results to those of short-term , intensive interventions could be achieved over a 24-month study period using a low-intensity intervention that approximates what is feasible in outpatient practice . A total of 144 obese , diabetic participants were r and omly assigned to a low-carbohydrate diet ( a low fat diet ( . Participants were provided weekly group nutrition education sessions for the first month , and monthly sessions thereafter through the end of 24 months . Weight , HbA(1c ) , glucose , and lipids were measured at baseline and 6 , 12 , and 24 months . Of the 144 enrolled participants , 68 returned for the month 24 assessment visit . Weights were retrieved from electronic medical records for an additional 57 participants ( total , 125 participants ) at month 24 . All participants with a baseline measurement and at least one of the three other measurements were included in the mixed-model analyses ( n = 138 ) . The low-intensity intervention result ed in modest weight loss in both groups at month 24 . At this time , participants in the low-carbohydrate group lost 1.5 kg , compared to 0.2 kg in the low-fat group ( P = 0.147 ) . Lipids , glycemic indexes , and dietary intake did not differ between groups at month 24 ( or at months 6 or 12 ) ( Clinical Trials.gov number , NCT00108459 )",
"BACKGROUND The blood pressure-lowering mechanism of low-sodium diet is not fully understood . METHODS We assessed the effects of salt restriction on cardiac parasympathetic function as measured by heart-rate variability ( HRV ) in mild to moderate hypertensive patients . Eighty patients were r and omized to a 6-month low- ( N = 40 ) or normal ( N = 40 ) sodium diet and a 24-h electrocardiogram ( ECG ) was carried out in the beginning of the study and at 6 months . Five time-domain and six frequency-domain HRV variables were analyzed : mean RR interval , st and ard deviation of normal RR intervals , mean of the st and ard deviations of all RR intervals for 5-min segments of the entire recording , percentage of differences between adjacent normal RR intervals exceeding 50 ms , square root of the mean of squared differences between adjacent normal RR intervals , total ( 0.01 - 0.40 Hz ) , high frequency ( HF , 0.15 - 0.40 Hz ) , low frequency ( LF , 0.04 - 0.15 Hz ) , very LF ( 0.01 - 0.04 Hz ) and LF/HF ratio . RESULTS Although blood pressure diminished significantly ( systolic blood pressure ( SBP ) from 149.9 + /- 14.7 mm Hg to 130.3 + /- 11.8 mm Hg , P diastolic blood pressure ( DBP ) from 98.0 + /- 6.4 mm Hg to 87.1 + /- 6.2 mm Hg , P < 0.001 ) after 6 months in the salt reduction group , no significant differences in the change between the groups could be detected . CONCLUSIONS A moderate , prolonged dietary sodium restriction does not alter HRV . Therefore , mechanisms other than cardiac autonomic mechanisms are likely to predominate in the blood pressure-lowering effect of salt restriction",
"OBJECTIVE Conflicting evidence exists as to weight loss produced by diets with different carbohydrate/protein ratio . The aim was to compare the long-term effects of high-protein vs. high-carbohydrate diet ( HPD , HCD ) , combined with cognitive behavior therapy ( CBT ) . DESIGN AND METHODS In a r and omized trial , 88 obese participants ( mean age , 46.7 ; mean BMI , 45.6 kg m(-2 ) ) were enrolled in a 3-week inpatient and 48-week outpatient treatment , with continuous CBT during the study period . All subjects consumed a restricted diet ( 1,200 kcal day(-1 ) for women , 1,500 for men ; 20 % energy from fat , HPD derived 34 % energy from proteins , 46 % from carbohydrates ; HCD 17 % from proteins , 64 % from carbohydrates . The primary outcome was 1-year percent weight loss . Secondary outcomes were attrition rates and changes in cardiovascular risk factors and psychological profile . RESULTS Attrition rates were similar between groups ( 25.6 % ) . In the intention-to-treat analysis , weight loss averaged 15.0 % in HPD and 13.3 % in HCD at 1 year , without any difference throughout the study period . Both diets produced a similar improvement in secondary outcomes . CONCLUSIONS The relative carbohydrate and protein content of the diet , when combined with intensive CBT , does not significantly affect attrition rate , weight loss and psychosocial outcome in patients with severe obesity",
"BACKGROUND AND AIMS To investigate the impact of a diet modeled on the traditional Cretan Mediterranean diet on metabolic control and vascular risk in type 2 diabetes . METHODS AND RESULTS Twenty-seven subjects ( 47 - 77 yrs ) with type 2 diabetes were r and omly assigned to consume either the intervention diet ad libitum or their usual diet for 12 weeks and then cross over to the alternate diet . Most of the meals and staple foods for the intervention diet were provided . Lipids , glycemic variables , blood pressure , homocysteine , C-reactive protein , plasma carotenoids and body composition ( anthropometry and dual energy X-ray absorptiometry ) were assessed at baseline , and at the end of both diet periods . Dietary adherence was monitored using plasma carotenoid and fatty acid ( FA ) analysis , complemented by diet diaries . Compared with usual diet , on the ad libitum Mediterranean intervention diet glycosylated haemoglobin fell from 7.1 % ( 95 % CI : 6.5 - 7.7 ) to 6.8 % ( 95 % CI : 6.3 - 7.3 ) ( p=0.012 ) and diet quality improved significantly [ plant : animal ( g/day ) food ratio increased from 1.3 ( 95 % CI : 1.1 - 1.5 ) to 5.4 ( 95 % CI : 4.3 - 6.6 ) ( p plasma lycopene and lutein/zeaxanthin increased ( 36 % and 25 % , respectively ) , plasma saturated and trans FAs decreased , and monounsaturated FAs increased . CONCLUSION A traditional moderate-fat Mediterranean diet improves glycemic control and diet quality in men and women with well-controlled type 2 diabetes , without adverse effects on weight"
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Background : The effect of statins on oxidative stress markers , such as malondialdehyde ( MDA ) , is still a matter of debate . We sought to address this issue by conducting a systematic review and meta- analysis of published data on the effect of statin treatment on systemic MDA concentrations . Methods : A literature search was conducted on MEDLINE / PubMed , ISI Web of Sciences and Scopus . Data were pooled using a r and om-effects model . Results : A total of 35 studies assessing MDA concentrations before and after statin treatment in 1512 participants ( mean age 53.6 years , 48.7 % males ) were identified . Extreme between- study heterogeneity was observed ( I2 = 96.0 % , p reduction in plasma MDA concentrations after treatment ( SMD = −1.47 µmol/l , 95 % confidence interval = −1.89 to −1.05 μmol/l ; p reduction in plasma MDA concentrations with statins ( −1.03 μmol/l , 95 % confidence interval = −1.52 to −0.29 μmol/l ; p = 0.036 ) . Conclusions : This systematic review and meta- analysis showed that statin treatment significantly reduces systemic MDA concentrations . However , the results should be interpreted with caution because of extreme between- study heterogeneity , which warrants further intervention studies | [
"Objective . To evaluate the effects of ezetimibe/simvastatin ( EZE/SIMV ) and rosuvastatin ( ROSUV ) on oxidative stress ( OS ) markers in patients with diabetic polyneuropathy ( DPN ) . Methods . We performed a r and omized , double-blind , placebo-controlled phase III clinical trial in adult patients with Type 2 Diabetes Mellitus ( T2DM ) and DPN , as evaluated by composite scores and nerve conduction studies ( NCS ) . Seventy-four subjects with T2DM were allocated 1 : 1 : 1 to placebo , EZE/SIMV 10/20 mg , or ROSUV 20 mg for 16 weeks . All patients were assessed before and after treatment : primary outcomes were lipid peroxidation ( LPO ) , and nitric oxide ( NO ) surrogate levels in plasma ; secondary outcomes included NCS , neuropathic symptom scores , and metabolic parameters . Data were expressed as mean ± SD or SEM , frequencies , and percentages ; we used nonparametric analysis . Results . LPO levels were reduced in both statin arms after 16 weeks of treatment ( p the placebo group . NO levels were not significantly affected by statin treatment , although a trend towards significance concerning increased NO levels was noted in both statin arms . No significant changes were observed for the NCS or composite scores . Discussion . EZE/SIMV and ROSUV are superior to placebo in reducing LPO in subjects with T2DM suffering from polyneuropathy . This trial is registered with NCT02129231",
"Simvastatin reduces the blood concentration of cholesterol by inhibiting hydroxymethylglutaryl-coenzyme A reductase , the rate-limiting enzyme in cholesterol synthesis , and thereby reduces the risk of cardiovascular disease . In addition , simvastatin treatment leads to a reduction in fluxes in mitochondrial respiratory complexes I and II and might thereby reduce the formation of reactive oxygen species , which have been implicated in the pathogenesis of arteriosclerosis . Therefore , we hypothesized that simvastatin may reduce oxidative stress in humans in vivo . We conducted a r and omized , double-blinded , placebo-controlled study in which subjects were treated with either 40 mg of simvastatin or placebo for 14 days . The endpoints were six biomarkers for oxidative stress , which represent intracellular oxidative stress to nucleic acids , lipid peroxidation and plasma antioxidants , that were measured in urine and plasma sample s. A total of 40 participants were included , of which 39 completed the trial . The observed differences between simvastatin and placebo groups in the primary outcomes , DNA and RNA oxidation , were small and nonsignificant ( p=0.68 ) , specifically , 3 % in the simvastatin group compared to 7.1 % in the placebo group for DNA oxidation and 7.3 % in the simvastatin group compared to 3.4 % in the placebo group . The differences in biomarkers related to plasma were not statistically significant between the treatments groups , with the exception of total vitamin E levels , which , as expected , were reduced in parallel with the reduction in plasma cholesterol . In healthy young male volunteers , short-term simvastatin treatment , which considerably reduces cholesterol , does not lead to a clinical ly relevant reduction in a panel of measures of oxidative stress . Whether simvastatin has effects on oxidative stress in diseased population s , such as diabetes or hemochromatosis , where oxidative stress is prominent , is unknown but seems unlikely",
"Lipid-lowering therapy has been reported to reduce several oxidative stress ( OS ) markers in hypercholesterolemia . Since OS is frequently associated with renal dysfunction , we aim ed to investigate the effect of hypolipidemic drugs on oxidative stress and plasma taurine ( Tau ) , a sulfur amino acid with a marked antioxidant effect , in chronic kidney disease ( CKD ) . We enrolled 30 CKD r and omized to receive three different hypolipidemic regimens for 12 months : simvastatin alone ( 40 mg/day ) or ezetimibe/simvastatin combined therapy ( 10/20 or 10/40 mg/day ) . Low molecular weight ( LMW ) thiols including homocysteine , cysteine , cysteinylglycine , glutathione , and glutamylcysteine in their reduced and total form and oxidative stress indices as malondialdehyde ( MDA ) and allantoin/uric acid ( All/UA ) ratio were also evaluated . Tau concentration significantly increased throughout the therapy . The rise of taurine was more striking for the group with the concomitant administration of ezetimibe/simvastatin 10/40 mg/day ( + 31.6 % after 1 year of therapy ) . A significant decrease of both MDA and All/UA ratio was observed during therapy for all patients ( −19 % for both MDA and All/UA ratio ) with a more pronounced effect in patients treated with ezetimibe/simvastatin 10/40 mg/day ( −26 % for MDA and −28 % for All/UA ratio ) . Besides , an increase of thiols reduced forms was found ( + 20.7 % of LMW thiols redox status ) with a greater effect in subjects treated with ezetimibe/simvastatin 10/40 mg/day ( + 24.7 % ) . Moreover , we demonstrated that oxidative stress improvement during therapy was correlated with increased taurine levels . We hypothesize that taurine may be responsible for the oxidative stress improvement observed during lipid-lowering treatment through the reduction of superoxide anion production at the respiratory chain activity level",
"BACKGROUND AND STUDY AIMS The prevalence of non-alcoholic fatty liver disease ( NAFLD ) appears to be increasing . The aim of the present study was to investigate the relationship between hepatic antioxidant paraoxonase 1 ( PON1 ) activity , lipid peroxidation and antioxidant enzymes in patients with NAFLD and the effect of atorvastatin . PATIENTS AND METHODS This study was conducted on 50 patients with NAFLD and 20 normal subjects matched for age and sex . All of them were subjected to the following investigations : abdominal ultrasonography , serum PON1 activity level , liver function tests , serum lipid profile , fasting and postpr and ial blood glucose and serum levels of malondialdehyde ( MDA ) and glutathione peroxidase ( GP ) . NAFLD patients were further r and omly classified into two groups ( 25 patients each ) , groups Ia and Ib . Only group Ia received atorvastatin 40 mg tablet for 8months . RESULTS Obesity , dyslipidaemia and impaired glucose tolerance were prevalent in group I. There was a significant decrease in serum PON1 activity with a significant increase in MDA and GP activity ( i.e. , there is a significant increase in lipid peroxidation rate ) in group I compared with group II . After atorvastatin therapy , there was a significant increase in serum PNO1 activity and significant decrease in serum MDA levels . CONCLUSION Patients with NAFLD show enhanced oxidative stress which may lead to non-alcoholic steatohepatitis ( NASH ) . Reduced PON1 activity and increased MDA could be considered a biochemical marker for lipid peroxidation , which require follow-up in patients with NAFLD . Atorvastatin may have a role in prevention of , or delay , the transformation of liver steatosis into NASH",
"Abstract —Recent evidence suggests that some benefit from the 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors may occur independent of lipid lowering . We aim ed to determine the effect of simvastatin on coronary endothelial function , endothelial NO synthase ( eNOS ) expression , and oxidative stress in experimental hypercholesterolemia ( HC ) in the absence of cholesterol lowering . Pigs were r and omized to 3 experimental groups : normal diet ( N group ) , high cholesterol diet ( HC group ) , and HC diet with simvastatin ( HC+S group ) for 12 weeks . Low density lipoprotein cholesterol was similarly increased in the HC and HC+S groups compared with the N group . In vitro analysis of coronary large- and small-vessel endothelium-dependent vasorelaxation was performed . The mean vasorelaxation of epicardial vessels to bradykinin was significantly attenuated in the HC group compared with the N group ( 32.3±1.2 % versus 42.9±1.6 % , respectively;P The maximal vasorelaxation to substance P was significantly attenuated in the HC group compared with the N group ( 50.5±11.9 % versus 79.3±5.3 % , respectively;P The maximal arteriolar vasorelaxation to bradykinin was also significantly attenuated in the HC group compared with the N group ( 71.9±4.9 % versus 96.8±1.34 % , respectively;P . Elevation of plasma F2-isoprostanes and thiobarbituric acid – reactive substances , markers of oxidative stress , occurred in the HC compared with the N group . These changes were reversed in the HC+S group . In summary , simvastatin preserves endothelial function in coronary epicardial vessels and arterioles in experimental HC ( in the absence of cholesterol lowering ) in association with an increase in coronary eNOS levels and a decrease in oxidative stress . These alterations may play a role in the reduction in cardiac events after treatment with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors",
"The aim of this study was to investigate the modulating effect of atorvastatin on serum paraoxonase 1 enzyme ( PON1 ) activity in type 2 diabetic Egyptian patients with or without nephropathy . The present study was carried out on the following groups : control group , which consisted of 30 healthy persons ; Group I , which consisted of 20 type 2 diabetic patients without nephropathy ; and Group II , which consisted of 20 type 2 diabetic patients with nephropathy . All the patients selected were under an antidiabetic regimen of insulin , and patients receiving antihypertensive agents were excluded from the follow-up study to avoid drug interaction fallacies . Twenty-two patients ( 15 without nephropathy and seven with nephropathy ) received atorvastatin in individually adjusted oral dosage ( range 10 - 20 mg ) once per day for 12 weeks . All cases were subjected to thorough clinical examination and history taking and measurement of serum levels of PON1 activity , malondialdehyde ( MDA ) , glutathione reductase activity , fasting glucose , total cholesterol , triglycerides , high-density lipoprotein ( HDL ) , low-density lipoprotein ( LDL ) , urea , and creatinine . Urine sample s were collected for determination of proteinuria . The obtained results showed that PON1 activity and HDL significantly decreased and fasting glucose significantly increased in Group I and Group II when compared to the control group , with significant difference in their levels between Group II and Group I. MDA , total cholesterol , and LDL levels significantly increased and glutathione reductase activity significantly decreased in Group I and Group II when compared to the control group . Urea , creatinine , and proteinuria levels showed significant increase in Group II when compared to the control group and Group I , with nonsignificant difference between control group and Group I. Atorvastatin therapy caused a significant increase in PON1 activity , and serum levels of MDA and glutathione reductase activity were significantly decreased and increased , respectively . Also , total cholesterol , triglyceride and LDL-cholesterol levels were significantly reduced with a significant increase in HDL-cholesterol levels . There was a significant modest reduction in serum urea and creatinine levels as well as in proteinuria level . Fasting glucose level was significantly reduced under the antidiabetic regimen of insulin through the follow-up period . PON1 activity showed a significant negative correlation with glucose and LDL , and a significant positive correlation with HDL in all the studied groups . It could be concluded that atorvastatin with its pleiotropic effects could provide optimal therapeutic intervention to control not only dyslipidemia , but also oxidative stress status with consequent improvement in the course of type 2 diabetes and diabetic nephropathy . More specifically , restoration of PON1 activity by atorvastatin opens a window to investigate other drugs that could provide a new adjuvant therapeutic line for better control of diabetes and diabetic nephropathy . Further research is also recommended to study the distribution of PON1 genetic polymorphism among the Egyptian population to explain the variability in its activity and its relationship with other factors that associate diabetes and its complications",
"Tissue factor ( TF ) plays a pivotal role in thrombus formation . Statins and angiotensin converting enzyme inhibitors attenuate expression of TF by distinct mechanism . Therefore , we hypothesized that combined therapy with simvastatin and ramipril may have additive beneficial anti-atherogenic effects to lower TF activity when compared with either drug alone . This was a r and omized , double-blind , placebo-controlled cross-over trial with three treatment arms ( each 2 months ) and two washout periods ( each 2 months ) . Fifty patients with type 2 diabetes were given simvastatin 20 mg and placebo , simvastatin 20 mg and ramipril 10 mg , or ramipril 10 mg and placebo daily during each treatment period . Simvastatin and ramipril monotherapy tended to reduce TF activity ( 0.53 to 0.46 nM , P=0.056 ; 0.54 to 0.50 nM , P=0.167 , respectively ) while combined therapy had a significant effect ( 0.64 to 0.43 nM , P reduced prothrombin fragment 1 + 2 ( F1 + 2 ) levels from their respective baselines ( P=0.037 , P reduced TF activity and F1 + 2 levels to a greater extent than either simvastatin or ramipril alone ( P=0.029 and P=0.040 by ANOVA , respectively ) . Percent changes in TF activity and percent changes in F1 + 2 levels were significantly correlated . All three therapies reduced CD40 lig and levels from their respective baselines ( P=0.098 , P Ramipril combined with simvastatin significantly reduces plasma TF activity and F1 + 2 levels to a greater extent than monotherapy with either drug in patients with type 2 diabetes",
"BACKGROUND Experimental evidence suggests a lipid-independent effect of statins on endothelial function and nitric oxide ( NO ) availability in humans . We investigated whether improvement in NO availability in hypercholesterolemia can be achieved rapidly with statins before lipid-lowering therapy is complete . METHODS We studied 41 patients ( 52 + /- 11 years ) with low-density lipoprotein ( LDL ) cholesterol > or = 130 mg/dL ( 179 + /- 45 mg/dL ) r and omly assigned to treatment either with atorvastatin ( 20 mg/day ) or cerivastatin ( 0.4 mg/day ) . Endothelium-dependent vasodilation of the forearm vasculature was measured by plethysmography and intra-arterial infusion of acetylcholine ( ACh ) after 3 days ( n = 18 ) and 14 days ( n = 39 ) of treatment . NO availability and oxidative stress were assessed by coinfusion of l-NMMA and vitamin C. RESULTS After 3 days of treatment , LDL-cholesterol decreased by 11.9 % with a further decrease to 29.6 % after 14 days ( P Endothelium-dependent vasodilation improved by + 46.7 % after 3 days of statin therapy compared with before therapy ( ACh 48 microg/min : + 15.7 + /- 10.6 vs + 10.7 + /- 10.8 mL/min per 100 mL , P endothelium-dependent vasodilation ( + 42.7 % compared with before therapy ) could be demonstrated after 14 days of treatment ( ACh 48 microg/min : + 17.7 + /- 10.3 vs + 12.4 + /- 9.3 mL/min per 100 mL before therapy , P endothelium-dependent vasodilation before but not after 3 or 14 days of statin therapy either . The improvement in endothelium-dependent vasodilation after therapy was no longer observed when the NO-synthase inhibitor l-NMMA was coinfused together with ACh . CONCLUSIONS Short-term lipid-lowering therapy with statins is able to improve endothelial function and NO availability almost completely after 3 days in hypercholesterolemic patients probably by decreasing oxidative stress . This improvement seems to be more rapid than the accompanying decline in LDL-cholesterol and not related to these lipid changes . This finding can support the concept of lipid-independent effects of statins in humans",
"BACKGROUND Statins are thought to have anti-atherogenic effects beyond cholesterol lowering . One such mechanism may involve reduction of oxidative stress . The aim of our study was to investigate and to compare the oxidative stress lowering capacity of atorvastatin with that of simvastatin in patients at high risk for cardiovascular disease using conventional markers and sensitive markers measured by highly specific techniques such as liquid chromatography t and em mass spectrometry . METHODS We included 30 statin-naive patients with diabetes mellitus , and /or obesity , and /or hypertension ( 12 male , 18 female , mean age 44.8±11.1 years ) , and r and omised them to receive either atorvastatin 10 mg or simvastatin 40 mg daily to obtain an equimolar cholesterol reduction . Blood and urine sample s were obtained at baseline and at 1 , 6 and 12 weeks . RESULTS Low-density lipoprotein ( LDL ) cholesterol and coenzyme Q10 decreased significantly in both groups . Simvastatin caused a faster initial LDL cholesterol lowering than atorvastatin ( p=0.01 ) , but the overall effect after 12 weeks of atorvastatin and simvastatin was similar . Plasma myeloperoxidase and malondialdehyde did not change during the study period in the two groups . Urinary F2-isoprostanes decreased gradually and significantly in the atorvastatin group but not in the simvastatin group , but the between-group difference was not significant . Urinary 8-hydroxy-2-deoxyguanosine did not change in the two groups",
"Objective High-density lipoprotein (HDL)-associated antioxidant paraoxonase ( PON ) may reduce low-density lipoprotein ( LDL ) oxidation and prevent atherosclerosis . The aim of this present study was to investigate the effect of the 3-hydroxy-3-methylglutaryl coenzyme A ( HMG-CoA ) reductase inhibitor atorvastatin on hydrogen-peroxide-induced DNA damage by comet assay and the correlation between oxidative DNA damage and antioxidant PON activity . Methods Thirteen type-II/a hyperlipidemic patients were enrolled in the study . We examined the effect of 10 mg/day atorvastatin treatment on lipid levels and the degree of DNA damage in lymphocytes separated from hyperlipidemic patients , nitric oxide ( NO ) , thiobarbituric acid-reactive substances ( TBARS ) , PON levels and activity . Results After 6 months , atorvastatin treatment significantly decreased serum cholesterol and LDL-cholesterol levels . The triglyceride level did not change , and there was no significant change in the HDL cholesterol level . The visual score characteristic to the degree of DNA damage in comet assay was significantly decreased , as well as the TBARS level , while the level of NO was non-significantly increased . PON activity and the PON/HDL ratio were significantly increased after atorvastatin treatment . There was a negative correlation between DNA damage and PON activity , as well as between DNA damage and the PON/HDL ratio before and after atorvastatin treatment . Conclusion These findings show that atorvastatin treatment favorably affected the lipid profile , increasing the activity of HDL-associated PON and decreasing the cytotoxic effect of oxidative stress",
"BACKGROUND We hypothesized that atorvastatin combined with amlodipine has additive beneficial vascular and metabolic effects that are superior to monotherapy in patients with hypertension . METHODS Forty-two patients were given atorvastatin 20mg/day and placebo , atorvastatin 20mg/day and amlodipine 10mg/day , or amlodipine 10mg/day and placebo during each 2-month treatment period of a r and omized , single-blind , placebo-controlled cross-over trial with two 2-month washout periods . RESULTS Atorvastatin combined with amlodipine or amlodipine alone significantly reduced blood pressure to a greater extent than atorvastatin alone ( all P Atorvastatin combined with amlodipine significantly reduced plasma malondialdehyde and improved flow-mediated dilation to a greater extent than atorvastatin or amlodipine alone ( all P Atorvastatin therapy significantly increased insulin levels ( P = 0.004 ) and decreased plasma adiponectin levels ( P = 0.016 ) and insulin sensitivity ( determined by QUICKI ; P = 0.026 ) relative to baseline measurements . Amlodipine therapy significantly decreased insulin levels ( P = 0.001 ) and increased adiponectin levels ( P insulin sensitivity ( P = 0.003 ) relative to baseline measurements . Atorvastatin combined with amlodipine therapy significantly increased adiponectin levels ( P insulin sensitivity ( P = 0.034 ) relative to baseline measurements . Effects of all three therapeutic arms on adiponectin levels and insulin sensitivity were statistically significant ( P Atorvastatin combined with amlodipine therapy improves endothelial function and increases adiponectin levels and insulin sensitivity to a greater extent than monotherapy with either drug in hypertensive patients",
"Abstract Background . In vitro and animal studies indicate that statins increase heme oxygenase-1 gene ( HMOX1 ) expression , which then , presumably , increases plasma bilirubin concentration . However , clinical confirmation that statins concomitantly increase HMOX1 expression and plasma bilirubin concentration is lacking . We hypothesized that in patients with stable angina atorvastatin therapy ( 20 mg/day for 10 weeks ) concomitantly increases total bilirubin concentration and HMOX1 expression , as assessed non-invasively by plasma analysis . Methods . In 44 patients with stable angina plasma concentrations of total bilirubin , HMOX1 mRNA and HMOX1 protein were measured before and after the statin treatment , as well as plasma concentrations of oxidized low-density lipoprotein ( OxLDL ) , malondialdehyde ( MDA ) , monocyte chemoattractant protein ( MCP-1 ) and C-reactive protein ( CRP ) . Results . Atorvastatin treatment increased total bilirubin concentration ( median 6.95 μmol/L vs. 8.55 , + 23.02 % ; p plasma HMOX1 mRNA and HMOX1 protein concentrations . Plasma concentrations of OxLDL ( − 31.85 % , p MCP-1 ( − 16.20 % , p = 0.020 ) and CRP ( − 7.32 % , p = 0.010 ) were decreased but MDA was not decreased ( 15.32 % , p = 0.107 ) . Within subjects , increment of plasma bilirubin concentration did not correlate with the changes in HMOX1 mRNA and protein concentrations , but correlated with low-density lipoprotein cholesterol decrement ( r = − 0.374 , p = 0.012 ) . Bilirubin increment did not correlate with the changes in oxidative and inflammatory markers . Conclusion . Our prospect i ve observational trial finally confirms that atorvastatin ( 20 mg/day for 10 weeks ) increases plasma total bilirubin concentration . However , it seems that this effect is HMOX1-independent",
"Abstract Background and objective : Hyperglycaemia leads to increased oxidative stress result ing in endothelial dysfunction . ACE inhibitors , antioxidants and HMG-CoA reductase inhibitors ( statins ) have been shown to improve endothelial function . The aim of this study was to compare the effects of NCB-02 ( a st and ardized preparation of curcuminoids ) , atorvastatin and placebo on endothelial function and its biomarkers in patients with type 2 diabetes mellitus . Methods : A total of 72 patients with type 2 diabetes were r and omized to receive NCB-02 ( two capsules containing curcumin 150 mg twice daily ) , atorvastatin 10 mg once daily or placebo for 8 weeks . Endothelial function assessment was performed at baseline and post-treatment using digital volume plethysmography ( salbutamol [ albuterol ] challenge test ) to measure change in reflective index , an indicator of arterial vascular tone . Blood sample s were similarly collected at baseline and post-treatment for estimations of malondialdehyde , endothelin-1 ( ET-1 ) , interleukin-6 ( IL-6 ) and tumour necrosis factor-α ( TNFα ) . Pre- and posttreatment safety assessment s were also conducted . ANOVA and paired t-test evaluations were used for comparison . Results : A total of 67 patients completed the study . At baseline , there was no significant difference in the various parameters tested . In all three groups , the change in reflective index at baseline was improvement in endothelial function after treatment with atorvastatin ( mean ± SD : −3.63 ± 3.17 % vs −8.95 ± 6.80 % , respectively ) and NCB-02 ( −2.69 ± 3.02 % vs −8.19 ± 5.73 % , respectively ) . Similarly , patients receiving atorvastatin or NCB-02 showed significant reductions in the levels of malondialdehyde , ET-1 , IL-6 and TNFα . No significant improvements were obtained in patients administered placebo . Conclusion : NCB-02 had a favourable effect , comparable to that of atorvastatin , on endothelial dysfunction in association with reductions in inflammatory cytokines and markers of oxidative stress . Further studies are needed to evaluate the potential long-term effects of NCB-02 and its combination with other herbal antioxidants ",
"BACKGROUND Oxidative stress contributes to endothelial dysfunction , an important step to the pathogenesis of atherosclerosis and coronary events . Latest studies revealed the existence of pleiotropic and especially antioxidant properties of statins . We sought to examine the effects of pravastatin on lipid peroxidation and endothelial function , independently from lipid-lowering , in patients with unstable angina ( UA ) . METHODS Thirty-seven patients ( males ) , 64.46+/-9.09 years , suffering from UA enrolled in the study . Patients were not on statin medication before admission and they received after r and omization either 40 mg pravastatin daily ( group A , n = 20 ) , or placebo ( group B , n = 17 ) . Malondialdehyde ( MDA ) concentration , an index of lipid peroxidation and plaque instability , flow-mediated dilatation ( FMD ) of the brachial artery and blood lipids were measured on the second day of hospitalization and 10 days later . RESULTS MDA decreased significantly in both groups ( A , p = 0.008 ; B , p = 0.003 ) . FMD increased significantly in group A ( p = 0.007 ) , whereas in group B it did not change . Serum lipids remained unaltered in all three groups . CONCLUSIONS Pravastatin administration improved FMD within 10 days and this favorable effect occurred before any significant reduction in blood lipids , revealing its pleiotropic effects during the early phase of an acute coronary syndrome . Circulating lipid peroxidation products in patients with UA decreased significantly during the same period independently of endothelial function and pravastatin therapy",
"OBJECTIVE To investigate the impact of Vitamin E on lipids and peroxidation during statin treatment . RESEARCH DESIGN AND METHODS T1DM patients with high cholesterol received Atorvastatin 20 mg with either placebo ( group AP , n = 11 ) or d-alpha-tocopherol 750 IU ( group AE , n = 11 ) daily . They were monitored for blood biochemistry , low-density lipoprotein ( LDL ) subfractions and lipid peroxidation at inclusion and after 3 and 6 months . RESULTS Serum cholesterol and triglycerides decreased to the same extent ( 29 and 21 % respectively ) in both groups . Serum tocopherol decreased by 18 % in AP and increased by 50 % in AE ( P Copper-induced production of thiobarbituric reactive substances in the LDL + VLDL fraction increased by 18 % in AP and did not change in AE ( P = 0.02 ) . The lagtime for the production of fluorescent products was prolonged by 13 min only in group AE ( P = 0.028 ) . Plasma malondialdehyde decreased by 35 % in both groups ( P = 0.002 ) but not when adjusted for lipids . CONCLUSIONS In T1DM Vitamin E supplements do not affect the lowering of lipids and plasma malondialdehyde achieved by Atorvastatin . They reverse the increase of in vitro peroxidation caused by Atorvastatin but do not achieve the decreases observed in patients not receiving lipid-lowering drugs . These results indicate that the antioxidant effect of Vitamin E is attenuated when given in conjunction with this statin",
"The effects of pravastatin on plasma lipid levels , in vitro oxidizability of the non-HDL fraction , metabolic control , urinary albumin excretion , and four serum enzymes ( SGPT , SGOT , GT and CPK ) were studied in 20 insulin-dependent diabetic patients ( IDDM ) with incipient nephropathy . The patients were divided into two groups and the study was carried out by a crossover design . After 12 weeks pravastatin treatment ( 20 mg daily ) , plasma cholesterol , LDL-cholesterol and apolipoprotein B ( Apo B ) decreased by 22 , 19 and 15 % , respectively . The thiobarbituric acid reactive substances ( TBARS ) formation and the oxidation lagtime of the non-HDL fraction during the in vitro incubation with copper were not changed before and after treatment . The HbA1c and blood glucose levels , urinary albumin excretion , SGOT , SGPT and GT were not influenced by pravastatin treatment . CPK activity was elevated after 12 weeks of pravastatin treatment , and this elevation persisted even after the 12 weeks placebo period . So , pravastatin could be used as an effective drug for IDDM patients with incipient nephropathy , but close monitoring of the CPK activity is recommended",
"Systemic sclerosis ( SSc ) has the highest case-specific mortality among the rheumatic diseases . Vascular dysfunction and structural wall abnormalities are among the earliest and fundamental alterations in SSc . Statins have a number of immunomodulating effects on vascular wall cells , which may modify the progression of vascular injury . The aim of this study was to evaluate the potential efficacy of statin therapy in ameliorating endothelial dysfunction ( ED ) in SSc by investigating the effect of statins on some markers that reflect endothelial activation in SSc . Forty patients with SSc were r and omized into two groups to receive 6 months ' treatment with atorvastatin ( n = 20 ; dose , 40 mg/day ) or placebo ( n = 20 ) as an adjuvant to existing therapy . Markers of ED including ET-1 , plasma nitrate levels , and thrombomodulin ( TM ) were evaluated by the enzyme-linked immunosorbent assay ( ELISA ) technique . Fibrinogen , high-sensitivity C-reactive protein ( hsCRP ) , ESR , lipid peroxide ( LP ) , and malonylaldehyde ( MDA ) levels were also assessed . Brachial flow-mediated vasodilatation was assessed by ultrasonography . Patients were studied at base line and after 6 months of statin therapy . After 6 months of therapy , ET-1 , ICAM-1 , sE-selectin , vWF , fibrinogen , ESR , hsCRP as well as LP and MDA levels declined and NO increased significantly in the statin-treated SSc group when compared to the placebo-treated group . Endothelium-dependent vasodilatation ( EDV ) improved significantly in the atorvastatin-treated group . The findings of this study demonstrated statin-mediated improvements in the endothelial function of SSc patients as well as immunomodulating effects . Statins may thus prove to be an invaluable addition to the therapy of the vasculopathy of SSc",
"Objective . To investigate the effect of atorvastatin therapy on inflammation , disease activity , endothelial dysfunction , and arterial stiffness in patients with rheumatoid arthritis ( RA ) . Methods . This study included 30 patients with early RA , r and omly divided into 2 groups . Group 1 ( n = 15 ) received methotrexate ( MTX ; 0.2 mg/kg/week ; mean ( 15.5 ± SD 1.3 ) plus prednisone ( 10 mg/day ) . Group 2 ( n = 15 ) received MTX and prednisone with the same previous doses plus atorvastatin therapy ( 40 mg/day ) . Ten healthy individuals of similar age and sex served as controls . Disease activity , lipid profile , serum malondialdehyde ( MDA ) , tumor necrosis factor-α ( TNF-α ) , resistin , adiponectin , and brachial artery flow-mediated dilation ( FMD ) were measured before and after 6 months of treatment . Results . Atorvastatin combined with MTX therapy significantly reduced serum total cholesterol , low-density lipoprotein cholesterol , and triglycerides , and increased high-density lipoprotein cholesterol ( p were significantly improved by the drug combinations ( p Conclusion . Atorvastatin therapy in patients with RA reduced disease activity and conventional and novel vascular risk factors that promote the atheromatous lesion . Therapy was also associated with concomitant improvement in endothelial function",
"BACKGROUND Atherogenic risk in subjects with metabolic syndrome is partly mediated by increased oxidative stress and subsequent endothelial dysfunction . Clinical trials have demonstrated differences in outcomes between subjects receiving lipophilic statins ( atorvastatin ) compared with hydrophilic statins ( pravastatin ) . However , whether these findings are attributable to differences in the doses administered or to nonlipid-lowering pleiotropic effects of statins on oxidative stress and vascular function remains unknown . We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function . METHODS Thirty-six subjects with hyperlipidemia and metabolic syndrome and /or diabetes were r and omized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily . Oxidative stress ( dROMs assay that measures lipid hydroperoxides , plasma thiobarbituric acid reactive substances [ TBARS ] , and aminothiol levels ) and brachial artery flow-mediated dilation ( FMD ) were measured at baseline and after 12 weeks of statin therapy . RESULTS Statin therapy reduced serum low-density lipoprotein cholesterol levels equally in both groups . Atorvastatin therapy was associated with a significant reduction in TBARS ( P = .006 ) and dROMs levels ( P = .02 ) , which was not observed in subjects treated with pravastatin . Endothelial function improved with statin therapy ( P = .02 ) , but there was no difference between the statin groups . CONCLUSION In hyperlipidemic subjects with metabolic syndrome , atorvastatin is associated with a greater reduction in lipid markers of oxidation compared with pravastatin . Whether these effects are responsible for the outcome differences in trials comparing these agents needs further investigation",
"BACKGROUND Simvastatin , a 3-hydroxy 3-methylglutaryl co-enzyme A ( HMG-CoA ) reductase inhibitor , is used widely for treatment of hypercholesterolemia . Simvastatin may be a suitable treatment for dyslipidemia in hemodialysis ( HD ) patients . However , investigation of the side-effects and safety of long-term administration of simvastatin to HD patients has been limited . In this study , we investigated the effects and safety of simvastatin and its effects on lipoprotein metabolism in hypercholesterolemic patients on HD . METHODS Simvastatin was administered at a dosage of 5 mg/day for 24 weeks to 38 HD patients with high serum total cholesterol ( TC ) levels ( 200 mg/dl ) or low high-density lipoprotein cholesterol ( HDL-C ) levels ( 35 mg/dl ) . Every four weeks , serum lipids , apolipoprotein , lipoprotein ( a ) [ Lp(a ) ] and malondialdehyde ( MDA ) levels were measured . In addition , lipid levels were determined in each lipoprotein fraction separated by ultracentrifugation . RESULTS After 24 weeks of simvastatin administration , TC significantly decreased by 25.7 % , and low-density lipoprotein cholesterol ( LDL-C ) was significantly decreased by 33.6 % . Triglyceride ( TG ) and HDL-C showed no significant changes . Apolipoprotein ( apo ) B significantly decreased by 24.5 % and apo E by 30.0 % . No significant changes were observed in the other apolipoproteins . MDA was also significantly decreased , whereas Lp(a ) was not significantly altered . In the lipoprotein fractions , very LDL cholesterol ( VLDL-C ) , intermediate-density lipoprotein cholesterol ( IDL-C ) , LDL1 cholesterol ( LDL1-C ) , and LDL2 cholesterol ( LDL2-C ) showed significant decreases . No particular side-effects were observed during the 12 months of simvastatin administration . CONCLUSIONS These results suggest that simvastatin appears to be safe and effective in HD patients with hypercholesterolemia",
"A 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor is recommended in hemodialysis ( HD ) patients with hypercholesterolemia to improve their lipid profiles . We evaluated effects of simvastatin on markers for inflammation , oxidative stress , and coagulation in HD patients . Sixty-two maintenance HD patients with serum cholesterol levels of 200 mg/dL or greater were r and omly assigned to the treatment group ( n = 31 ; 8 men , 23 women ; age , 63 + /- 11 years ) and administered simvastatin , 20 mg/d , for 8 weeks or to the control group ( n = 31 ; 10 men , 21 women ; age , 60 + /- 12 years ) . We measured cholesterol , albumin , high-sensitivity C-reactive protein ( hs-CRP ) , malondialdehyde ( MDA ; an index of lipid peroxidation ) , and D-dimer ( a marker of intravascular coagulation ) in blood at baseline and again at 8 weeks . Fifty-eight of 62 patients completed the study . In the control group , total cholesterol , serum albumin , hs-CRP , MDA , and D-dimer levels did not change . In the treatment group , simvastatin administration for 8 weeks significantly reduced total cholesterol levels from 232 + /- 25 to 165 + /- 39 mg/dL ( P hs-CRP levels from a median of 0.23 mg/dL ( range , 0.05 to 1.63 mg/dL ) to 0.12 mg/dL ( range , serum albumin levels from 3.4 + /- 0.3 to 3.6 + /- 0.4 g/dL ( P simvastatin did not affect MDA and D-dimer levels . These results suggest that in addition to the lipid-lowering effect , simvastatin had an antiinflammatory effect in HD patients . Considering that atherosclerosis is inflammation of the vascular wall , simvastatin may have a beneficial effect on cardiovascular disease , in part because it alleviates inflammation",
"Mechanisms underlying biological effects of statin and angiotensin-converting enzyme inhibitor therapies differ . Thus , we studied vascular responses to combination therapy in hypercholesterolemic patients . A r and omized , double-blind , placebo-controlled , crossover trial was conducted with 50 hypercholesterolemic patients with simvastatin and either placebo or ramipril ( study I ) and in 45 hypercholesterolemic diabetic patients with simvastatin or ramipril with placebo or simvastatin combined with ramipril ( study II ) for 2 months with 2 months washout . In study I simvastatin combined with ramipril significantly reduced blood pressure after 2 months . Simvastatin alone or combined with ramipril significantly changed lipoproteins , improved percent flow-mediated dilator response to hyperemia by 30±5 % and 53±6 % , respectively ( P and reduced plasma levels of malondialdehyde by 4±7 % ( P = 0.026 ) and 25±4 % ( P respectively . Monocyte chemoattractant protein-1 levels decreased by 3±3 % and 12±2 % , respectively ( P = 0.049 and P respectively ) , C-reactive protein levels changed by 0 % and 18 % , respectively ( P = 0.036 and P respectively ) , and plasminogen activator inhibitor-1 antigen levels changed by −7±7 % and 17±5 % , respectively ( P = 0.828 and P change lipoproteins and C-reactive protein levels , however , simvastatin combined with ramipril significantly changed lipoproteins and C-reactive protein levels more than ramipril alone ( P respectively ) . Ramipril alone or simvastatin combined with ramipril significantly improved the percent flow-mediated dilator response to hyperemia ( both P 0.001 ) , however , simvastatin combined with ramipril showed significantly more improvement than ramipril alone ( P ANOVA ) . Simvastatin combined with ramipril significantly improved endothelium-dependent vasodilation and fibrinolysis potential and reduced plasma levels of oxidant stress and inflammation markers in hypercholesterolemic patients",
"Statins and fibrates influence endothelial activity and consequently atherogenesis but the mechanisms are not well understood . Twenty Type 2 diabetic patients with dyslipidemia were treated 3 months with simvastatin ( 20 mg daily ) and then 3 months with fenofibrate ( 200 mg daily ) with 2 months of wash-out between the two treatments . Laboratory parameters of oxidative stress , fibrinolysis and endothelial function were evaluated before and at the end of each treatment period . The significant decrease in serum total and LDL-cholesterol concentrations ( P simvastatin was associated with an increase in serum N-acetyl-beta-glucosaminidase activity ( P ascorbic acid ( P plasminogen activator inhibitor ( PAI-1 ) ( P vonWillebr and factor ( P E-selectin ( P vascular endothelial growth factor ( P decrease in plasma glutathione ( P levels . Fenofibrate caused a significant decrease in serum triglyceride concentration ( P plasma malondialdehyde ( P increase in plasma PAI-1 ( P P-selectin ( P concentrations . We conclude that simvastatin and fenofibrate interact , by different mechanisms , with oxidative stress , a key factor in the modification of fibrinolysis and endothelial function in Type 2 diabetes",
"OBJECTIVES Statins may exhibit anti-inflammatory and antioxidant effects . Whether different statins at equivalent doses or the combination of low-dose statin with ezetimibe have comparable anti-inflammatory and antioxidant effects is unknown . The aim of this study was to compare the effects of simvastatin , simvastatin/ezetimibe or rosuvastatin at equivalent low-density lipoprotein cholesterol lowering doses on inflammation and oxidative stress indices in subjects with hypercholesterolemia . METHODS This was a pre-specified analysis of a prospect i ve , r and omized , open-label , blinded endpoint ( PROBE ) study . We enrolled one hundred and fifty three ( n = 153 ) hypercholesterolemic subjects who were r and omized to receive simvastatin 40 mg or simvastatin/ezetimibe 10/10 mg or rosuvastatin 10 mg daily . Plasma 8-Epi prostagl and in F2 alpha ( 8-epiPGF2a ) , oxidized LDL ( oxLDL ) and lipoprotein-associated phospholipase A2 ( Lp-PLA2 ) activity and mass were measured at baseline and following 12 weeks of treatment . RESULTS A significant reduction in plasma 8-isoprostane and oxLDL levels was observed in all treatment groups [ by 10 % , 8 % and 6 % ( p simvastatin , simvastatin/ezetimibe and rosuvastatin groups , respectively ] . In all treatment groups a significant reduction in total plasma Lp-PLA2 activity and mass was observed ( by 36 % , 31 % and 38 % and 36 % , 32 % and 32 % for simvastatin , simvastatin/ezetimibe and rosuvastatin , respectively , p CONCLUSIONS Simvastatin 40 mg , simvastatin/ezetimibe 10/10 mg and rosuvastatin 10 mg significantly reduced 8-epiPGF2a , oxLDL and Lp-PLA2 activity and mass to a similar extent",
"Background Atorvastatin , an inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase , which is used for lipid-lowering therapy , is an effective statin modulating process involved in atherosclerosis . Paraoxonase ( PON ) associated with high-density lipoprotein ( HDL ) has been postulated to have a role in protecting low-density lipoprotein ( LDL ) against oxidative modification . Oxidation of serum LDL is an important early step in the development of atherosclerosis and auto-antibodies against oxidized LDL ( AuAb-oxLDL ) reflect in-vivo LDL oxidation . Design and methods To examine the effect of atorvastatin ( 10 mg/day ) therapy on PON activity in serum and HDL , the study group included 40 patients with dyslipidemia ( 19 women and 21 men ) , 25 of whom had hypercholesterolemia and of 15 of whom had mixed-type hyperlipidemia . By taking blood sample s from the patients , levels of serum lipids , lipid peroxidation product as malondialdehyde ( MDA ) , total antioxidant status ( TAS ) and AuAb-oxLDL and the activities of PON in serum and isolated HDL were determined . Results The mean levels of total cholesterol , triglyceride , LDL-cholesterol , MDA and AuAb-oxLDL were decreased while HDL-cholesterol and TAS were increased significantly after lipid-lowering therapy in patients with dyslipidemia . On the other h and , PON activities in serum and HDL were increased significantly . The percentage increase in serum PON activity was associated significantly with the percentage decrease in serum AuAb-oxLDL ( r=−0.32 , P=0.047 ) and that of HDL PON activity was associated with the percentage increase in HDL-cholesterol level after atorvastatin therapy ( r=0.52 , P=0.001 ) . The therapy was more effective in increasing PON activity in patients with HDL levels above 35 mg/dl . Conclusion It was concluded that atorvastatin therapy in dyslipidemic patients decreases the level of oxidative stress and increases PON activity , especially in patients with HDL levels above 35 mg/dl",
"Hyperlipidemia is commonly observed in patients with type 2 diabetes and is an independent risk factor for cardiovascular disease . The authors tested the effect of atorvastatin ( 10 mg/d ) on 110 hyperlipidemic type 2 diabetes patients with low-density lipoprotein cholesterol ( LDL-C ) levels exceeding 130 mg/d . The primary efficacy end point was the percentage change in LDL-C and high-density lipoprotein cholesterol ( HDL-C ) , and secondary efficacy included the percentage change in apolipoproteins at weeks 6 , 12 , and 24 . The tertiary goal was percentage change in free radical scavenger enzymes and oxidative stress . LDL-C was reduced by 25 % , 39.3 % , and 49.2 % . A similar trend was observed in total cholesterol , triglyceride , non-HDL-C , and apolipoprotein ( apo ) B-100 . HDL-C was raised by 3.2 % , 6 % , and 8.2 % . A similar trend was seen in apo A-1 . Copper zinc-superoxide dismutase and glutathione were raised significantly ( P glutathione-S-transferase and glutathione peroxidase activities were nonsignificant . Malondialdehyde was decreased significantly ( P Atorvastatin improves the lipoprotein profile and oxidative status in patients with type 2 diabetes",
"BACKGROUND It has been shown that there is an increase in oxidative stress in polycystic ovary syndrome ( PCOS ) . Statins are considered to have a pleiotropic effect other than their lipid-lowering effect . These effects may be mediated in part by reducing oxidative stress . METHODS This r and omized , double-blind , placebo-controlled study was conducted to assess the effect of atorvastatin on serum malondialdehyde ( MDA ) concentrations as a marker of oxidative stress in patients with PCOS . Forty medication-naïve patients with PCOS were r and omized to either atorvastatin 20 mg daily or placebo for 3 months . A 3-month extension study for both groups of patients was undertaken with metformin 1500 mg daily after completing initial 3 months of atorvastatin or placebo . RESULTS There was a significant decrease of MDA concentrations with atorvastatin [ mean ( sem ) ] [ 0.29 ( 0.04 ) vs. 0.25 ( 0.02 ) μmol/liter ; P metformin result ed in further reduction of MDA levels with atorvastatin compared with baseline [ 0.25 ( 0.02 ) baseline vs. 0.23 ( 0.03 ) μmol/liter for atorvastatin treated ; P = 0.02 ] . There was also a significant correlation between the reduction in MDA with a reduction in high-sensitivity C-reactive protein ( r = 0.71 , P increase in 25-hydroxyvitamin D ( 25OHD ; r = -0.68 , P = 0.02 ) , and a reduction in testosterone levels ( r = 0.63 , P = 0.01 ) . Multiple linear regression analysis revealed Δ25OHD , ΔC-reactive protein , and Δtestosterone were independent predictors of changes in MDA after atorvastatin treatment . No correlation was observed between the reductions in serum MDA concentrations with changes in the lipid parameters . CONCLUSIONS Twelve weeks of atorvastatin led to a significant reduction in oxidative stress as determined by MDA concentrations among patients with polycystic ovary syndrome that was independently predicted by changes in testosterone , 25OHD , and high-sensitivity C-reactive protein",
"BACKGROUND Increased oxidative stress , a common feature in chronic heart failure , has been associated with inflammation , endothelial dysfunction , and extracellular matrix degradation . Statins have known anti-inflammatory and anti-oxidant effects ; however , their role in chronic heart failure is still controversial . METHODS This was a prospect i ve study of 38 patients with stable systolic chronic heart failure . Patients received a 4-week placebo course , followed by atorvastatin 20 mg/day for 8 weeks . Oxidative stress , inflammation and remodeling markers , brachial artery flow-mediated vasodilation , and 6-minute walk test were evaluated at baseline , 4 , and 8 weeks . RESULTS Mean age was 58 + /- 12 . Mean left ventricular ejection fraction was 27 % + /- 12 % . No significant differences were observed between measurements at baseline and after placebo . Atorvastatin induced a significant decrease of matrix metalloproteinase-9 activity , high-sensitivity C-reactive protein , tumor necrosis factor-alpha , interleukin-6 , and malondialdehyde , and a significant increase of endothelial superoxide dismutase activity when compared with placebo . No differences in tissue inhibitor of matrix metalloproteinase and matrix metalloproteinase-2 activities were observed . Atorvastatin use was associated with an improved flow-dependent brachial vasodilation and exercise capacity in the 6-minute walk test . CONCLUSIONS In chronic heart failure patients , atorvastatin therapy is associated with a decrease of inflammation and extracellular matrix remodeling , improving both endothelial function and exercise capacity",
"Because the mechanisms of the biological effects of statin and angiotensin converting enzyme inhibitor therapies differ , we studied the vascular responses to these therapies in hypercholesterolemic patients with coronary artery disease . We administered simvastatin 20 mg and placebo or ramipril 10 mg daily during 2 months with washout 2 months to 32 hypercholesterolemic patients with coronary artery disease . This study was r and omized , double-blind , placebo-controlled , crossover in design . Simvastatin alone or combined with ramipril significantly changed lipoproteins , and improved the percent flow-mediated dilator response to hyperemia relative to baseline measurements by 33 + /- 6 % and by 50 + /- 14 % , respectively ( both P plasma levels of nitrate relative to baseline measurements ( P=0.413 and 0.037 , respectively ) , the plasma MDA levels relative to baseline measurements by 8 + /- 8 % and by 18 + /- 9 % ( P=0.039 and P MCP-1 relative to baseline measurements by 7 + /- 4 % and by 13 + /- 3 % , respectively ( P=0.019 and P CRP from 0.22 to 0.14 mg/dl and from 0.22 to 0.15 mg/dl , respectively ( P=0.124 and 0.002 , respectively ) , and PAI-1 antigen relative to baseline measurements ( P=0.690 and 0.018 , respectively ) . However , simvastatin combined with ramipril changed to greater but statistically insignificant extent the percent flow-mediated dilator response to hyperemia and plasma levels of nitrate , MDA , MCP-1 , and PAI-1 antigen than simvastatin alone . Simvastatin alone or combined with ramipril showed significant beneficial effects on endothelial function in hypercholesterolemic patients with coronary artery disease . However , simvastatin combined with ramipril did not significantly change , compared with simvastatin alone"
] | 41162e28-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND : This analysis summarized Cochrane review s that assess the effects of neuraxial anesthesia on perioperative rates of death , chest infections , and myocardial infa rct ion . METHODS : A search was performed in the Cochrane Data base of Systematic Review s on July 13 , 2012 . We have included all Cochrane systematic review s that examined subjects of any age undergoing any type of surgical ( open or endoscopic ) procedure , compared neuraxial anesthesia to general anesthesia alone for the surgical anesthesia , or neuraxial anesthesia plus general anesthesia to general anesthesia alone for the surgical anesthesia , and included death , chest infections , myocardial infa rct ion , and /or serious adverse events as outcomes . Studies included in these review s were selected on the same criteria . RESULTS : Nine Cochrane review s were selected for this overview . Their scores on the Overview Quality Assessment Question naire varied from 4 to 6 of a maximal possible score of 7 . Compared with general anesthesia , neuraxial anesthesia reduced the 0- to-30-day mortality ( risk ratio [ RR ] 0.71 ; 95 % confidence interval [ CI ] , 0.53–0.94 ; I2 = 0 % ) based on 20 studies that included 3006 participants . Neuraxial anesthesia also decreased the risk of pneumonia ( RR 0.45 ; 95 % CI , 0.26–0.79 ; I2 = 0 % ) based on 5 studies that included 400 participants . No difference was detected in the risk of myocardial infa rct ion between the 2 techniques ( RR 1.17 ; 95 % CI , 0.57–2.37 ; I2 = 0 % ) based on 6 studies with 849 participants . Compared with general anesthesia alone , adding neuraxial anesthesia to general anesthesia did not affect the 0- to-30-day mortality ( RR 1.07 ; 95 % CI , 0.76–1.51 ; I2 = 0 % ) based on 18 studies with 3228 participants . No difference was detected in the risk of myocardial infa rct ion between combined neuraxial anesthesia – general anesthesia and general anesthesia alone ( RR 0.69 ; 95 % CI , 0.44–1.09 ; I2 = 0 % ) based on 8 studies that included 1580 participants . Adding a neuraxial anesthesia to general anesthesia reduced the risk of pneumonia ( RR 0.69 ; 95 % CI , 0.49–0.98 ; I2 = 9 % ) after adjustment for publication bias and based on 9 studies that included 2433 participants . The quality of the evidence was judged as moderate for all 6 comparisons . The quality of the reporting score of complications related to neuraxial blocks was 9 ( 4 to 12 [ median { range } ] ) for a possible maximum score of 14 . CONCLUSIONS : Compared with general anesthesia , neuraxial anesthesia may reduce the 0-to-30-day mortality for patients undergoing a surgery with an intermediate-to-high cardiac risk ( level of evidence moderate ) . Large r and omized controlled trials on the difference in death and major outcomes between regional and general anesthesia are required | [
"PURPOSE : Colorectal surgery is associated with postoperative ileus , which contributes to delayed discharge . This study was design ed to investigate the effect of thoracic epidural anesthesia and analgesia on gastrointestinal function after colorectal surgery under st and ardized controlled postoperative care . METHODS : Forty-two patients diagnosed with either colonic cancer , diverticulitis , polyps , or adenoma , and scheduled for elective colorectal surgery , were r and omly assigned to either postoperative patient-controlled analgesia ( PCA ) with intravenous morphine ( n=21 ) or epidural analgesia with a mixture of bupivacaine and fentanyl ( n=21 ) . Postoperative early oral feeding and assistance to mobilization were offered to all patients . Pain visual analog scale ( 1–100 mm ) , passage of flatus and bowel movements , length of hospital stay , and readiness for discharge were recorded . RESULTS : Pain visual analog scale ( visual analog scale , 1–100 mm ) at rest , on coughing , and daily on mobilization was significantly lower in the epidural group compared with the patient-controlled analgesia group . Median values for the visual analog scale group were 7 ( 95 percent confidence interval , 2–18 ) mm , 19 ( 95 percent confidence interval , 4–38 ) mm , and 10 ( 95 percent confidence interval , 5–33 ) mm , respectively , and , for the patient-controlled analgesia group , were 24 ( 95 percent confidence interval , 18–51 ) mm , 59 ( 95 percent confidence interval , 33–74 ) mm , and 40 ( 95 percent confidence interval , 29–79 ) mm , respectively ( P ) . Intake of protein and calories and time out of bed were similar in both groups . Mean time intervals ± st and ard deviation from surgery to first flatus and first bowel movement occurred earlier in the epidural group , 1.9±0.6 days and 3.1±1.7 days , respectively , compared with patient-controlled analgesia , 3.6±1.5 days and 4.6 ± 1.6 days , respectively ( P occurred in 33 percent of the patient-controlled analgesia group and 28 percent of the epidural group . There was no significant difference in length of hospital stay between the two groups with a mean of 7.3±3.7 days in the patient-controlled analgesia group and 8.5±4.2 days in the epidural group . Readiness for discharge was similar in both groups . CONCLUSION : Thoracic epidural analgesia has distinct advantages over patient-controlled analgesia morphine in providing superior quality of analgesia and shortening the duration of postoperative ileus . However , discharge home was not faster , indicating that other perioperative factors influence the length of hospital stay",
"One hundred and thirty-two elderly patients undergoing emergency hip surgery were r and omly allocated to receive subarachnoid block ( SAB ) or general anaesthesia ( GA ) . Using the 125.I fibrinogen uptake test , deep vein thrombosis was found to occur in 17 of 37 patients in the SAB group and 30 of 39 patients in the GA group ( P 0.05 ) . Blood loss was 513 ml ( + /- SEM 44 ) in the SAB group and 714 ml ( + /- SEM 67 ) in the GA group ( P less than 0.01 ) . Hypoxaemia was present preoperatively ( mean PaO2 9.2 kPa ) . Immediately following general anaesthesia , the mean fall in PaO2 was 0.86 kPa compared with preoperative values but only 0.16 kPa following subarachnoid block ( P less than 0.01 ) . At 24 hours postoperatively the fall in PaO2 was similar in both groups and recovered only slowly during the first week . Twelve patients died , three in the SAB group and nine in the GA group . This difference in mortality was not statistically significant",
"The effects of thoracic epidural anesthesia ( TEA ) on total body oxygen supply-dem and ratio are complex due to potential influences on both O2 delivery ( & OV0422;O2 ) and consumption ( & OV0312;O2 ) . One hundred and five patients undergoing abdominal aortic surgery were r and omly assigned to one of three groups to compare the cardiovascular and metabolic responses associated with ( 1 ) thoracic epidural anesthesia plus light general anesthesia ( group TEA ) ; ( 2 ) general anesthesia with halothane ( group H ) ; and ( 3 ) neuroleptanalgesia ( group NLA ) . Values of cardiac index ( CI ) and & OV0422;O2 were less intra operatively in the TEA group than in the H or NLA groups , while & OV0312;O2 values were similar . & OV0312;O2 during recovery was greater in both the TEA and NLA groups than in the H group . Consequently the oxygen supply-dem and ratio ( & OV0422;O2/&OV0312;O2 ) was less in the TEA group throughout the perioperative period and about 30 % below baseline values during early recovery . At comparable & OV0312;O2 , CI and mixed venous O2 saturation were always less in the TEA group than in the NLA group . Heart rate was slowest intra operatively during TEA , and stroke work was less with TEA than with NLA . As cardiac filling pressure and systemic vascular resistance did not differ among the three groups , reduced adaptation of CI to tissue O2 needs during TEA was attributed to negative inotropic and chronotropic effects of the sympathetic blockade . We conclude that in patients undergoing abdominal aortic surgery , TEA has no apparent advantage over general anesthesia",
"BACKGROUND This study was undertaken to determine if thoracic epidural analgesia is of practical benefit after bowel resection . METHODS Patients were prospect ively r and omized to receive either a thoracic epidural or patient-controlled analgesia for pain control after bowel resection . A st and ardized postoperative protocol was instituted after surgery . RESULTS Pain scores were significantly lower in the epidural group . Return of bowel function , and interval to discharge was not different between groups . Cost and complication rates were significantly higher in the epidural group . CONCLUSIONS Although pain scores were significantly lower in the epidural group , this did not translate into a quicker return of bowel function or earlier discharge of the patient . Furthermore , the epidural group had a significantly higher complication rate and cost . Therefore , while thoracic epidural analgesia provides superior pain control , it does not offer a significant advantage over patient-controlled analgesia in return of bowel function after bowel resection",
" Fifty-five patients presenting with fractured neck of femur were r and omly allocated to either a st and ard general anaesthetic or spinal block in the lateral position combined with light sedation . The comparability of the two groups was established . There was little difference in the intra-operative course of postoperative morbidity in the two groups . There was a statistically significant difference in post-operative mortality between two groups , the general anaesthetic group showing a much higher mortality than the spinal group",
" One hundred and one patients were r and omly allocated to have their peripheral vascular surgery performed under general anaesthesia ( 51 patients ) or spinal anaesthesia ( 50 patients ) . Intraoperative haemodynamic changes were markedly different between the two groups with a higher incidence of hypotension in the spinal group ( 72 % vs 31 % ) and a higher incidence of hypertension in the general anaesthesia group ( 22 % vs 0 % ) . Blood loss was significantly less in the spinal group ( 560 , SD 340 , ml vs 792 , SD 440 , ml ) . Postoperatively three patients from the general anaesthesia group died from causes unrelated to the anaesthesia , and one had a myocardial infa rct . Two patients in the spinal group had myocardial infa rcts , both had been treated for bradycardia and hypotension intraoperatively , and one died . There was a significantly higher incidence of postoperative chest infection in the general anaesthesia group ( 33 % vs 16 % ) . There was no significant difference between the groups in the incidence of postoperative confusion , or lower limb amputation rate or need for further surgery prior to hospital discharge",
" One hundred and forty-eight patients undergoing \" pin- and -plate \" repair of fractured neck of femur received either subarachnoid blockade or general anaesthesia . The patients were followed up for 1 year after surgery . At the end of the year , 34 % had died and 50 % had returned home . Twelve per cent were either in hospital or in institutional care ; 4 % were lost to follow up . The mean duration of acute plus convalescent hospital bed occupancy was 84.4 days . There was a significantly lower mortality in the subarachnoid anaesthetic group by 14 days after surgery . The majority of the deaths in the general anaesthetic group were clustered between 6 and 16 days . However , at the end of 2 months the mortality rates were similar in both groups . It is conceivable that the difference in the distribution of deaths between the groups was a result of thrombo-embolism",
"Forty elderly patients ( mean age 78.9 years ) undergoing acute surgery for hip fracture were given at r and om either spinal analgesia with bupivacaine 0.75 % or general anaesthesia with diazepam , fentanly and N2O/O2 . Mental function was studied pre‐operatively with an abbreviated mental test and 1 week and 3 months postoperatively in both groups . Mortality and number of complications was similar in the two groups , but a shorter time of ambulation was seen in the spinal group compared to the general anaesthetic group . No persistent impairment in mental function was found after acute hip surgery under spinal or general anaesthesia and the only advantage of regional technique was a shorter time of ambulation",
"We assessed the efficacy and side effects of postoperative analgesia with three different pain regimens in 90 patients undergoing major abdominal surgery . The patients were r and omly assigned to one of three groups : epidural morphine ( EM ) or sufentanil ( ES ) , both combined with bupivacaine , or IM morphine ( IM ) at fixed intervals . Before incision , patients in the epidural groups received sufentanil or morphine in bupivacaine via a thoracic catheter , followed by a continuous infusion 1 h later . General anesthesia consisted of N2 O/O2 and isoflurane for all groups . Patients in all groups received IV sufentanil as part of their anesthetic management . Patients in the IM group received IV sufentanil 1 [ micro sign]g/kg before incision , and patients in all groups received sufentanil 10 [ micro sign]g for inadequate analgesia . Postoperatively , the epidural or IM treatment was continued for > or = to5 days . Postoperative analgesia at rest and during coughing and movement was significantly better in the epidural groups than in the IM group during the 5 consecutive days . There were no significant differences between the epidural groups . The incidence of most side effects was similar in all groups . We conclude that epidural analgesia provided better pain relief than IM analgesia , even if the latter was optimized by fixed-dose administration at fixed intervals and included adjustments on dem and . Epidural sufentanil and morphine , both combined with bupivacaine , seemed to be equally effective with similar side effects . Implication s : Postoperative analgesia with epidural sufentanil or morphine and bupivacaine after major abdominal surgery seemed to be better than the conventional method of IM morphine treatment , despite optimal administration , i.e. , fixed doses at fixed intervals with regular adjustments . Analgesic efficacy and side effects of epidural sufentanil and morphine were similar . ( Anesth Analg 1998;87:1346 - 53",
"The choice between regional versus general anaesthesia for elderly patients undergoing hip surgery is debated . It is vitally important to see if the type of anaesthetic administered affects per- and postoperative morbidity and mortality . Seventy women more than 75 yr old suitable for spinal anaesthesia were included in this study . They were r and omly divided into two groups : in one ( n = 35 ) , general anaesthesia was given with sodium thiopentone , fentanyl , enflurane and vecuronium ; in the other ( n = 35 ) , spinal anaesthesia was performed with 3 ml 0.5 % bupivacaine in isobaric solution . During the anaesthetic period , there were no statistically significant differences between both groups in systolic arterial pressure falls or in increases in the heart rate X systolic arterial pressure product . No serious cardiovascular collapse was encountered . Seven patients ( 20 % ) receiving general anaesthesia had mental changes against four only ( 14.2 % ) in the spinal group . In patients having general anaesthesia , 22.9 % developed bronchopneumonia as opposed to 8.6 % in the spinal anaesthesia group ( p less than 0.05 ) . The mortality rate at three months was rather similar in the two groups . It was concluded that , in order to reduce the incidence of postoperative central dysfunction and bronchopneumonia , spinal anaesthesia should be preferred in geriatric patients for lower limb surgery",
"It has long been held that the acute-phase and neuroendocrine response to stress requires afferent neural input for its propagation . To further clarify the role of afferent neural impulses in this process and to determine the ability of epidural anesthesia to attenuate the normal perioperative stress response , 39 patients undergoing uncomplicated abdominal aortic replacement were r and omized to receive either general anesthesia with postoperative patient-controlled intravenous morphine ( n = 19 ) or combined regional/general anesthesia with intraoperative epidural catheter anesthesia using Bupivacaine to the T4 dermatome level followed by postoperative epidural morphine ( n = 20 ) . The stress response was quantitated by blinded measurement of baseline and postoperative ( 0 , 12 , 24 , 48 , and 72 hours ) serum cortisol , epinephrine norepinephrine , total catecholamines , interleukin (IL)-1beta , IL-6 , tumor necrosis factor (TNF)-alpha , and C-reactive protein ( CRP ) . Total operative time ( 4.2 + /- 0.3 vs 4.3 + /- 0.4 hours ) , 72-hour fluid requirement ( 7.0 + /- 0.6 vs 6.8 + /- 0.71 mL ) , and length of hospitalization ( 7.8 + /- 1.4 vs 8.1 + /- 1.2 days ) were not different between groups . All patients showed a significant increase in cortisol , epinephrine , norepinephrine , total catecholamines , CRP , and IL-6 in the postoperative period ( P IL-1beta and TNF-alpha were less predictable and undetectable in most patients . There was no difference in any of the stress response indices between those patients receiving patient-controlled or epidural catheter anesthesia . In fact , the only parameter that was predictive of increased activation of the stress response was the length of operation , irrespective of anesthetic method . Those patients with operative times greater than 5 hours ( n = 10 ) developed significantly higher CRP , IL-1beta , IL-6 , and TNF-alpha levels ( P < 0.05 ) at 12 and 24 hours postoperatively than those with total operative times less than 4 hours ( n = 16 ) . The neuroendocrine response to major surgical stress is propagated normally despite epidural blockade and is intensified with prolonged operative times . The inflammatory cytokines appear to play a major role in this process",
"Background There are no r and omized studies on neonatal outcome after spinal versus general anesthesia for cesarean delivery in preeclamptic patients with a nonreassuring fetal heart trace . This study examined both markers of neonatal hypoxia and maternal hemodynamics . Methods Seventy patients were r and omized to general ( n = 35 ) or spinal anesthesia ( n = 35 ) . The general anesthesia group received thiopentone , magnesium sulfate , and suxamethonium intravenously before intubation , followed by 50 % nitrous oxide in oxygen , 0.75–1.5 % isoflurane , and morphine after delivery . The target end-tidal partial pressure of carbon dioxide ( Pco2 ) was 30–34 mmHg . The spinal anesthesia group received 1.8 ml hyperbaric bupivacaine plus 10 & mgr;g fentanyl at the L3–L4 interspace . Heart rate and blood pressure were measured at specific time points . Hypotension was treated with ephedrine . Maternal arterial and neonatal umbilical arterial blood gas sample s were taken at delivery . Resuscitation requirements were recorded . Results In both groups , hemodynamic measures remained within acceptable limits . Spinal anesthesia patients required more ephedrine ( 13.7 vs. 2.7 mg ) . Maternal Paco2 was lower in the spinal group ( 28.9 vs. 32.4 mmHg ) . One-minute Apgar scores were lower after general anesthesia . Base deficit was greater ( 7.13 vs. 4.68 mEq/l ) and neonatal umbilical arterial pH was lower ( 7.20 vs. 7.23 ) after spinal anesthesia . Post hoc analysis showed that if maternal diastolic blood pressure on admission was greater than 110 mmHg , neonatal umbilical arterial base deficit was greater after spinal anesthesia . There was no difference in the number of patients with Apgar scores less than 7 at 1 or 5 min or umbilical arterial pH less than 7.2 or in the requirements for resuscitation . Conclusions In preeclamptic patients with a nonreassuring fetal heart trace , spinal anesthesia for cesarean delivery was associated with a greater mean neonatal umbilical arterial base deficit and a lower median umbilical arterial pH. The clinical significance remains to be established . Maternal hemodynamics were similar and acceptable with either anesthetic technique",
"In 1987 , Yeager et al. reported that intraoperative epidural anesthesia with local anesthetics and postoperative epidural analgesia with opiates diminished postoperative morbidity . In our first clinical trial on this topic , the better postoperative analgesia with epidural bupivacaine-fentanyl failed to improve the outcome after major abdominal operations over that obtained with parenteral piritramide . This r and omized controlled investigation was design ed to assess whether intraoperative epidural anesthesia with bupivacaine plus light general anesthesia and postoperative epidural analgesia with morphine would diminish the overall rate of postoperative complications after major abdominal operations compared with general anesthesia ( without epidural ) followed by patient controlled analgesia with morphine , and with intraoperative epidural anesthesia with bupivacaine and light general anesthesia followed by postoperative bupivacaine-morphine analgesia . METHODS . A total of 292 patients undergoing infrarenal aortic bypass operation , gastric resection , gastrectomy , duodenum-preserving pancreatic resection , Whipple 's operation or cystectomy and neobladder formation were r and omly divided into three groups : 1 . PCA group ( patient controlled analgesia , n = 107 ) : patients were operated on under general anesthesia ( midazolam , fentanyl , N2O/O2 , if necessary with addition of halothane , enflurane or isoflurane ; muscle relaxation with pancuronium bromide ) . Postoperative management consisted in patient-controlled analgesia with morphine ( Prominject ) , bolus 2 mg , lock-out 5 min ( recovery room , intensive care unit ) or 15 min ( surgical ward ) . 2 . EBM group ( epidural bupivacaine+morphine , n = 95 ) : operation under light general anesthesia ( midazolam , low-dose fentanyl , N2O/O2 , pancuronium bromide ) . In addition , a mixture of bupivacaine ( 0.25 % ) and morphine ( 60 micrograms/ml ) was infused ( approximately 0.1 ml/kg.h ) via an epidural catheter during and after the operation ( approximately 72 h ) . 3 . EM group ( epidural morphine , n = 90 ) : operation under the same kind of general-epidural anesthesia as in the EBM group . Postoperatively , epidural injection of morphine ( 0.05 mg/kg in 10 ml of saline ) on request up to the 3rd postoperative day . Quality of analgesia ( at rest and when patients coughed vigorously ) , strength of cough , and rate-pressure product were recorded at 8:00 h , 12:00 noon , 16:00 h and 20:00 h on the 1st , 2nd and 3rd postoperative days . Incidence and intensity of all postoperative complications ( cardiovascular , pulmonary , renal and other organ failure , reoperations , major infection , sepsis , thromboembolism , metabolic and mental disturbances ) were assessed from the day of operation until discharge or death ( n = 10 ) , respectively . RESULTS AND DISCUSSION . In the PCA and EM groups analgesia was equal but of slightly inferior quality compared with the EBM group . The ability to cough was best in the EBM group and significantly worse in the PCA and EM groups , with no difference between the last two . ( ABSTRACT TRUNCATED AT 400 WORDS",
"The mortality following surgical correction of upper femoral fractures was investigated in 578 patients , over the age of 50 yr , r and omly allocated to receive spinal ( bupivacaine ) or general ( enflurane or neurolept ) anaesthesia . Thirty days after surgery the mortality was 6 % after spinal and 8 % after general anaesthesia ( ns ) . Six months to 2 years after surgery the mortality was identical in the two groups . There were no differences with respect to ambulation and discharge . The estimated blood loss was smaller ( P less than 0.05 ) in patients receiving spinal anaesthesia . Regardless of the anaesthetic technique , a high short-term mortality was related to age , male sex , and trochanteric fracture , whereas excess long-term mortality was related to male sex and high ASA scores",
"The authors conducted a r and omized controlled clinical trial to evaluate the effect of epidural anesthesia and postoperative analgesia ( EAA ) on postoperative morbidity in a group of high-risk surgical patients . A total of 53 patients were admitted to the study , 28 received EAA , and 25 received st and ard anesthetic and analgesic techniques without EAA . Surgical “ risk ” was evaluated preoperatively and found to be comparable in the two groups . When compared to control patients , patients who received EAA had a reduction in the overall postoperative complication rate ( P = 0.002 ) and in the incidence of cardiovascular failure ( P = 0.007 ) and major infectious complications ( P = 0.007 ) . Urinary cortisol excretion , a marker of the stress response , was significantly diminished during the first 24 postoperative hours in the group receiving EAA ( P = 0.025 ) . Finally , hospital costs were significantly reduced for patients who received EAA ( P = 0.02 ) . The authors conclude that EAA exerted a significant beneficial effect on operative outcome in a group of high risk surgical patients",
"UNLABELLED The aim of our study was to compare epidural anesthesia and analgesia ( EDA ) with ropivacaine versus general anesthesia followed by IV patient-controlled analgesia with morphine ( GA/PCA ) after hip replacement regarding pain , side effects , and discharge from the postanesthesia care unit . After ethics committee approval , r and omization , and informed consent , 90 patients were enrolled . In Group EDA , epidural anesthesia ( ropivacaine 10 mg/mL , 15 - 25 mL ) was followed by an epidural infusion ( 2 mg/mL , 4 - 6 mL/h for 24 h , plus top-up doses of 6 - 10 mL for 48 h ) . GA/PCA patients received general anesthesia ( isoflurane/N2O/fentanyl ) followed by IV patient-controlled analgesia with morphine postoperatively . Pain was assessed by using visual analog scales ( 0 - 100 mm ) at rest and during physiotherapy . Pain at rest was less in the EDA ( n = 43 ) group than in the GA/PCA ( n = 45 ) group ( at 10 h : 11.8+/-12.9 vs. 28.4+/-17.1 [ P discharge from the postanesthesia care unit earlier than GA/PCA patients ( 5.6+/-8.9 vs. 39.7+/-41.5 min ) , the actual discharge time was comparable . The median time for first passage of flatus was shorter in the EDA group than in the GA/PCA group ( 26 vs. 47 h ) . Nausea and vomiting were more common in the GA/PCA group than in the EDA group ( 16 % vs. 28 % and 11 % vs. 22 % , respectively ) , whereas hypotension ( 11 % vs. 4 % ) and bradycardia ( 14 % vs. 2 % ) were less frequent . Under the conditions of the present study , EDA with ropivacaine provided pain control after hip replacement superior to that provided by IV patient-controlled analgesia with morphine , particularly during the first 24 h. Both approaches to pain management were equally safe . IMPLICATION S Compared with general anesthesia and postoperative IV patient-controlled analgesia with morphine , epidural anesthesia and analgesia with the new local anesthetic ropivacaine enables patients to be discharged sooner from a postanesthesia care unit and provides superior pain relief during the first 24 h after hip replacement",
"Cardiovascular and hormonal responses to reconstructive abdominal aortic surgery were studied in 20 patients anaesthetized either with moderate-dose fentanyl ( 20 micrograms kg-1 ) combined with isoflurane , nitrous oxide and oxygen ( n = 10 ) , or with thoracolumbar epidural bupivacaine combined with isoflurane , nitrous oxide and oxygen ( n = 10 ) . After the start of operation , hypotension occurred in four patients in the epidural group . In both groups , the aortic cross-clamping caused slight increases both in mean arterial pressure and in calculated systemic vascular resistance , and a significant decrease in cardiac index . At the same time , a marked increase in plasma vasopressin was seen in the fentanyl group . Plasma catecholamines were low in both groups . After aortic declamping , the cardiac index improved in both groups , although two patients in the fentanyl group and four patients in the epidural group were hypotensive . Post-operatively , eight patients in the fentanyl group were hypertensive , versus none in the epidural group , in which bupivacaine-fentanyl was administered epidurally . At the same time , plasma vasopressin and adrenaline increased significantly in both groups , whereas plasma noradrenaline did so only in the fentanyl group . The results suggest that thoracolumbar epidural bupivacaine combined with low-dose isoflurane in nitrous-oxide-oxygen prevents intra-operative hypertension and tachycardia , but it may cause hypotension . Post-operative hypertension and tachycardia as well as the increase in plasma noradrenaline are prevented by epidural administration of bupivacaine-fentanyl",
"In a primary analysis of a large recently completed r and omized trial in 915 high-risk patients undergoing major abdominal surgery , we found no difference in outcome between patients receiving perioperative epidural analgesia and those receiving IV opioids , apart from the incidence of respiratory failure . Therefore , we performed a selected number of predetermined subgroup analyses to identify specific types of patients who may have derived benefit from epidural analgesia . We found no difference in outcome between epidural and control groups in subgroups at increased risk of respiratory or cardiac complications or undergoing aortic surgery , nor in a subgroup with failed epidural block ( all P > 0.05 ) . There was a small reduction in the duration of postoperative ventilation ( geometric mean [ SD ] : control group , 0.3 [ 6.5 ] h , versus epidural group , 0.2 [ 4.8 ] h ; P = 0.048 ) . No differences were found in length of stay in intensive care or in the hospital . There was no relationship between frequency of use of epidural analgesia in routine practice outside the trial and benefit from epidural analgesia in the trial . We found no evidence that perioperative epidural analgesia significantly influences major morbidity or mortality after major abdominal surgery",
"Background Choice of perioperative analgesia may affect the rate of recovery of gastrointestinal function and thus duration and cost of hospitalization after colonic surgery",
"Objective To evaluate the maternal and fetal effects of three anesthetic methods used r and omly in women with severe preeclampsia who required cesarean delivery . Methods Eighty women with severe preeclampsia , who were to be delivered by cesarean , were r and omized to general ( 26 women ) , epidural ( 27 ) , or combined spinalepidural ( 27 ) anesthesia . The mean preoperative blood pressure ( BP ) was approximately 170/110 mmHg , and all women had proteinuria . Anesthetic and obstetric management included antihypertensive drug therapy and limited intravenous ( IV ) fluid and drug therapy . Results The mean gestational age at delivery was 34.8 weeks . All infants were born in good condition as assessed by Apgar scores and umbilical arterial blood gas determinations . Maternal hypotension result ing from regional anesthesia was managed without excessive IV fluid administration . Similarly , maternal BP was managed without severe hypertensive effects in women undergoing general anesthesia . There were no serious maternal or fetal complications attributable to any of the three anesthetic methods . Conclusion General as well as regional anesthetic methods are equally acceptable for cesarean delivery in pregnancies complicated by severe preeclampsia if steps are taken to ensure a careful approach to either method",
"Purpose The goal of this r and omized study was to determine whether combined general and epidural anaesthesia with postoperative epidural analgesia , compared with general anaesthesia and postoperative intravenous analgesia , reduced the incidence of perioperative myocardial ischaemia in patients undergoing elective aortic surgery . Method Patients were r and omly assigned to one of two groups . One group ( EPI , n = 48 ) received combined general and epidural anaesthesia and postoperative epidural analgesia for 48 hrs . The other group ( GA , n = 51 ) received general anaesthesia followed by postoperative intravenous analgesia . Anaesthetic goals were to maintain haemodynamic stability ( ± 20 % of preoperative values ) , and a stroke volume > 1 ml · kg−1 . A Holter monitor was attached to each patient the day before surgery . Leads 11 , V2 , and V5 were monitored . Myocardial ischaemia was defined as ST segment depression > 1 mm measured at 80 millisec beyond the J point or an elevation of 2 mm 60 millisec beyond the J point which lasted > 60 sec. An event that lasted > 60 sec but returned to the baseline for > 60 sec and then recurred , was counted as two separate events . The Holter tapes were review ed by a cardiologist blind to the patient ’s group . Results There were no demographic differences between the two groups . Myocardial ischaemia was common ; it occurred in 55 % of patients . In hospital , preoperative ischaemia was uncommon ( CA = 3 , EP1 = 8) . Intraoperative ischaemia was common ( GA = 18 , EP1 = 25 ) . Mesenteric traction produced the largest number of ischaemic ( GA = 11 , EP1 = 11 ) events . Postoperative ischaemia was most common on the day of surgery . Termination of epidural analgesia produced a burst of ischaemia ( 60 events in 9 patients ) Conclusion Combined general and epidural anaesthesia and postoperative epidural analgesia do not reduce the incidence of myocardial ischaemia or morbidity compared with general anaesthesia and postoperative intravenous analgesia . RésuméObjectifDéterminer avec une élude r and omisée si l’anesthésie générale et épidurale combinée suivie d’une analgésie épidurale postopératoire comparée à l’anesthésie générale suivie d’une analgésie intraveineuse postopératoire diminuait l’incidence de l’ischémie myocardique périopératoire chez des patients soumis à une chirurgie aortique non urgente . MéthodeLes patients étaient répartis au hasard en deux groupes . Un groupe ( IEP1 , n = 48 ) recevait une anesthésie générale et épidurale combinée et une analgésie épidurale postopératoire pendant 48 h. L’autre groupe ( AG , n = 51 ) recevait une anesthésie générale suivie d’une analgésie intraveineuse postopératoire . Les objectifs anesthésiques étaient de maintenir la stabilité hémodynamique ( ± 20 % des valeurs préopératoires ) , et un volume d’éjection > 1 ml · kg−1 . Un jour avant l’intervention , un moniteur de Holter avec les dérivations 11 , V2 et V5 était relié au patient . Une depression du segment ST plus gr and e que 1 mm mesurée 80 millisec après le point J ou une élévation de 2 mm mesurée 60 millisec après le point J était considérée comme une ischémie myocardique si elle durait plus de 60 sec. Un épisode de plus de 60 sec avec un retour à la ligne de base pendant 60 sec et plus avec récurrence , était considéré comme 2 épisodes séparés . Les bobines du Holter était révisée par un cardiologue neutre . RésultatsLes données démographiques étaient entre les groupes . L’ischémie myocardique était fréquente , survenant chez 55 % des patients . A l’hôpital , l’ischémie préopératoire était rare ( AG = 3 , EP1 = 8) . L’ischémie peropératoire était fréquente ( AG = 18 , EP1 = 25 ) . La traction mésentérique provoquait le plus gr and nombre d’épisodes d’ischémie ( AG = 11 , EP1 = 11 ) . L’ischémie postopératoire survenait le plus fréquemment le jour même de la chirurgie . L’arrêt de l’analgésie épidurale provoquait des poussées ischémiques ( 60 épisodes chez 9 patients ) . Conclusion L’anesthésie générale et épidurale combinée à l’analgésie épidurale ne réduit pas l’incidence de l’ischémie myocardique et de la morbidité comparativement à l’anesthésie générale suivie d’une l’analgésie intraveineuese",
"Background Despite evidence that regional anesthesia may be associated with fewer perioperative complications than general anesthesia , most studies that have compared cardiac outcome after general or regional anesthesia alone have not shown major differences . This study examines the impact of anesthetic choice on cardiac outcome in patients undergoing peripheral vascular surgery who have a high likelihood of associated coronary artery disease . Methods Four hundred twenty‐three patients , between 1988 and 1991 , were r and omly assigned to receive general ( n = 138 ) , epidural ( n = 149 ) , or spinal anesthesia ( n = 136 ) for femoral to distal artery bypass surgery . All patients were monitored with radial artery and pulmonary artery catheters . Postoperatively , patients were in a monitored setting for 48–72 h and had daily electrocardiograms for 4–5 days and creatine phosphokinase/isoenzymes every 8 h x 3 , then daily for 4 days . Cardiac outcomes recorded were myocardial infa rct ion , angina , and congestive heart failure . Results Baseline clinical characteristics were not different between anesthetic groups . Overall , the patient population included 86 % who were diabetic , 69 % with hypertension , 36 % with a history of a prior myocardial infa rct ion , and 41 % with a history of smoking . Cardiovascular morbidity and overall mortality were not significantly different between groups when analyzed by either intention to treat or type of anesthesia received . In the intention to treat analysis , incidences of cardiac event or death for general , spinal , and epidural groups were 16.7 % , 21.3 % , and 15.4 % , respectively . The absolute risk difference observed between general and all regional anesthesia groups for cardiac event or death was ‐1.6 % ( 95 % confidence interval ‐9.2 % , 6.1 % ) This reflected a nonsignificant trend for lower risk of postoperative events with general anesthesia . Conclusions The choice of anesthesia , when delivered as described , does not significantly influence cardiac morbidity and overall mortality in patients undergoing peripheral vascular surgery",
"In a prospect i ve study , patients undergoing cholecystectomy were r and omly allocated to receive ( a ) intermittent intramuscular morphine ( n = 25 ) , ( b ) continuous intravenous morphine infusion ( n = 25 ) or ( c ) epidural bupivacaine ( n = 25 ) for postoperative pain relief . Morphine by intravenous infusion provided comparable pain relief to intermittent intramuscular morphine ; there was no significant difference in the incidence of postoperative pulmonary complications . Patients receiving epidural bupivacaine for 12 h had better analgesia than patients receiving morphine ( P Arterial oxygen tensions were also significantly higher in the epidural group for the first three postoperative days ( P incidence of pulmonary complications ( P chest infection ( P < 0.05 )",
"Sixty patients scheduled for colonic surgery were r and omly allocated to four groups according to postoperative pain medication : I. Control group , the patients received oxycodone intramuscularly ( 0.15 mg kg1 ) on request . II . Epidural bupivacaine ( 0.25 % ) continuously administered by infusion pump , 66 ml h‐1 , for 48 h. III . Epidural morphine , 2–6 mg , at the end of operation and repeated on the first and second postoperative mornings . IV . Epidural morphine , 2–6 mg per die , administered for 48 h continuously by infusion pump . All patients received a balanced anaesthesia with enflurane , fentanyl and vecuronium . Postoperatively , intramuscular oxycodone was given on request . There were no significant differences between the groups in changes in peak flow , spirometry and blood‐gas analyses postoperatively . Pain intensity ( visual analogue scale ) was lower in Groups II and III at 3 h and in Group IV at 24 h compared to the control Group I. All the epidurally treated groups needed less additional analgesics than the control Group I. Postoperatively bowel movements occurred on the second day in Group II ( bupivacaine ) as compared to the fourth day in all other groups ( P < 0.05 )",
"Background Improvement in patient outcome and reduced use of medical re sources may result from using epidural anesthesia and analgesia as compared with general anesthesia and intravenous opioids , although the relative importance of intraoperative versus postoperative technique has not been studied . This prospect i ve , double-masked , r and omized clinical trial was design ed to compare alternate combinations of intraoperative anesthesia and postoperative analgesia with respect to postoperative outcomes in patients undergoing surgery of the abdominal aorta . Methods One hundred sixty-eight patients undergoing surgery of the abdominal aorta were r and omly assigned to receive either thoracic epidural anesthesia combined with a light general anesthesia or general anesthesia alone intraoperatively and either intravenous or epidural patient-controlled analgesia postoperatively ( four treatment groups ) . Patient-controlled analgesia was continued for at least 72 h. Protocol s were used to st and ardize perioperative medical management and to preserve masking intraoperatively and postoperatively . A uniform surveillance strategy was used for the identification of prospect ively defined postoperative complications . Outcome evaluation included postoperative hospital length of stay , direct medical costs , selected postoperative morbidities , and postoperative recovery milestones . Results Length of stay and direct medical costs for patients surviving to discharge were similar among the four treatment groups . Postoperative outcomes were similar among the four treatment groups with respect to death , myocardial infa rct ion , myocardial ischemia , reoperation , pneumonia , and renal failure . Epidural patient-controlled analgesia was associated with a significantly shorter time to extubation ( P = 0.002 ) . Times to intensive care unit discharge , ward admission , first bowel sounds , first flatus , tolerating clear liquids , tolerating regular diet , and independent ambulation were similar among the four treatment groups . Postoperative pain scores were also similar among the four treatment groups . Conclusions In patients undergoing surgery of the abdominal aorta , thoracic epidural anesthesia combined with a light general anesthesia and followed by either intravenous or epidural patient-controlled analgesia , offers no major advantage or disadvantage when compared with general anesthesia alone followed by either intravenous or epidural patient-controlled analgesia",
"Background : Perioperative morbidity may be modifiable in high risk patients by the anesthesiologist 's choice of either regional or general anesthesia . This clinical trial compared outcomes between epidural ( EA ) and general ( GA ) anesthesia/analgesia regimens In a group of patients at high risk for cardiac and other morbidity who were undergoing similarly stressful surgical procedures . Methods : One hundred patients scheduled for elective vascular reconstruction of the lower extremities were r and omized to receive either EA for surgery followed by epidural analgesia , or GA for surgery followed by intravenous patient-controlled analgesia . Hemodynamic monitoring , blood pressure , and heart rate limits were determined prior to r and omization . Management of anesthesia in the immediate postoperative period was st and ardized . The data collected included continuous electrocardiographic monitoring from the day before surgery through the third postoperative day , serial electrocardiograms , and cardiac enzymes . Cardiac ischemia , myocardial infa rct ion , unstable angina , and cardiac death were identified by a cardiologist blinded to the type of anesthesia received . Other major morbidity was determined at the time of hospital discharge and at 1 and 6 months after surgery . Results : Eleven patients who received GA required regrafting or an embolectomy during their hospital stay , compared with two patients who received EA . This association of GA with reoperation remained significant after adjustment for baseline differences . Cardiac outcomes were similar in the two groups with respect to perioperative death ( 1 EA and 1 GA ) , death within 6 months ( 4 EA and 3 GA ) , nonfatal myocardial infa rct ion within 7 days ( 2 EA and 2 GA ) , unstable angina ( 0 EA and 2 GA ) , and myocardial ischemia following r and omization ( 17 EA and 23 GA ) . Rates of major infections in the two groups ( 1 EA and 2 GA ) , renal failure ( 3 EA and 3 GA ) , and pulmonary complications ( 3 EA and 7 GA ) also were similar . Conclusions : Carefully conducted epidural and general anesthesia appear to be associated with comparable rates of cardiac and most other morbidity in patients undergoing lower extremity vascular surgery . However , compared with general anesthesia , epidural anesthesia is associated with a lower incidence of reoperatlon for inadequate tissue perfusion and , therefore , may be advantageous for this surgical population",
"Sixty patients with fractured neck of femur and scheduled for surgical correction were r and omly allocated to receive one of three anaesthetic techniques : general anaesthesia ; spinal analgesia ; psoas compartment block . The patients in the local anaesthetic groups also received a light general anaesthetic . There was little difference in the pre‐ , intra‐ and postoperative events , and no difference in postoperative mortality",
"In a prospect i ve r and omized multi-centre study , the mortality following internal fixation surgery for fracture of the upper femur was investigated in 538 elderly patients allocated to receive subarachnoid blockade or general ( narcotic-relaxant ) anaesthesia . The 28-day mortality was 6.6 % with subarachnoid , and 5.9 % with general , anaesthesia . The difference was not significant ( 95 % confidence limits : -3.5 to + 4.8 ) . At 1 year following surgery , the mortality was 20.4 % . Increasing age , ischaemic heart disease , cardiac failure , preoperative arrhythmias and poor ASA status were all associated with increases in early and long term mortality . A delay to surgery of more than 24 h from admission was also associated with an increased 28-day mortality . Senile dementia and admission other than from the patient 's own home , were factors associated with a poorer long term outcome . From the point of view of mortality , subarachnoid anaesthesia did not appear to confer any advantages over general anaesthesia in non-prosthetic surgery for hip fracture in the elderly",
"To assess the role of postoperative analgesia on myocardial ischemia after aortic surgery , we compared intravenous patient-controlled analgesia ( PCA ) with thoracic epidural analgesia ( TEA ) . One hundred twenty-four patients were prospect ively r and omized to the PCA or TEA group . In the TEA group , a T6 - 7 or T7 - 8 epidural catheter was inserted before the induction of general anesthesia . Within 1 h of the end of surgery , analgesia and 24-h two-channel Holter monitoring were begun . Myocardial ischemia was defined as ST segment depression > or = to1 mm , 0.06 s after the J point , and lasting for more than 1 min . In the PCA group , a bolus of morphine , 0.05 mg/kg , was given , followed by 0.02 mg/kg of morphine on dem and every 10 min . Bupivacaine 0.125 % and fentanyl 10 micro g/mL was used in the TEA group . Analgesics were titrated to maintain a visual analog scale score overall incidence of myocardial ischemia was 18.4%-18.2 % for TEA and 18.6 % for PCA ( P = not significant ) . There were no differences between the groups in the total duration of ischemia per patient ( 22.2 + /- 119.8 min for TEA and 20.5 + /- 99 min for PCA ) and the number of episodes per patient ( 0.69 + /- 2.1 for TEA and 1.2 + /- 4.9 for PCA ) . Twenty-three patients had an adverse cardiac outcome , although there were no differences between the groups . The postoperative pain control was superior with TEA . In these patients undergoing elective aortic surgery , the use of postoperative TEA did not result in a lower incidence of early myocardial ischemia compared with intravenous PCA with morphine , despite better analgesia with TEA . Implication s : Postoperative myocardial ischemia is associated with adverse cardiac outcome . Using Holter monitoring after aortic surgery , this study shows that the use of thoracic epidural analgesia with bupivacaine and fentanyl did not result in a lower incidence of myocardial ischemia compared with intravenous patient-controlled analgesia with morphine . ( Anesth Analg 1997;85:1233 - 9",
" Fifty-seven patients , all over the age of 64 , with femoral neck fracture were r and omized to receive epidural or halothane anesthesia to see if the anesthetic technique influenced the incidence of postoperative confusion . All patients were lucid on admission . Using the American Psychiatric Association 's Diagnostic and Statistical Manual of Mental Disorders ( DSM-III ) as criteria for confusion , we found that 44 % of the patients developed confusion that correlated closely to a history of mental depression ( P incidence of confusion between the two anesthetic groups . In patients given halothane , however , early postoperative hypoxemia was associated with confusion ( P postoperative complications and almost four times longer hospitalization times . It is concluded that anticholinergic medication and a history of mental depression are predominant risk factors for development of postoperative confusion and in this respect are more important than the anesthetic technique",
"Objective To test the hypothesis that epidural anesthesia and postoperative epidural analgesia decrease the incidence of death and major complications during and after four types of intraabdominal surgical procedures . Summary Background Data Even though many beneficial aspects of epidural anesthesia have been reported , clinical trials of epidural anesthesia for outcome of surgical patients have shown conflicting results . Methods The authors studied 1,021 patients who required anesthesia for one of the intraabdominal aortic , gastric , biliary , or colon operations . They were assigned r and omly to receive either general anesthesia and postoperative analgesia with parenteral opioids ( group 1 ) or epidural plus light general anesthesia and postoperative epidural morphine ( group 2 ) . The patients were monitored for death and major complications during and for 30 days after surgery , as well as for postoperative pain , time of ambulation , and length of hospital stay . Results Overall , there was no significant difference in the incidence of death and major complications between the two groups . For abdominal aortic surgical patients , unlike the other three types of surgical patients , the overall incidence of death and major complications was significantly lower in group 2 patients ( 22 % ) than in group 1 patients ( 37 % ) , stemming from differences in the incidence of new myocardial infa rct ion , stroke , and respiratory failure between the two groups . Overall , group 2 patients received significantly less analgesic medication but had better pain relief than group 1 patients . In group 2 aortic patients , endotracheal intubation time was 13 hours shorter and surgical intensive care stay was 3.5 hours shorter . Conclusions The effect of anesthetic and postoperative analgesic techniques on perioperative outcome varies with the type of operation performed . Overall , epidural analgesia provides better postoperative pain relief . Epidural anesthesia and epidural analgesia improve the overall outcome and shorten the intubation time and intensive care stay in patients undergoing abdominal aortic operations",
"Quantitative assessment of myocardial ischaemia during incremental spinal , single-dose spinal and general anaesthesia may provide guidelines for the choice of anaesthetic technique for osteo synthesis of hip fractures in the elderly atherosclerotic individual . Forty-three patients with coronary artery disease were allocated to receive either incremental spinal anaesthesia ( bupivacaine 0.5 % plain ) ( A ) , single-dose spinal anaesthesia ( 2.5 mL of bupivacaine 0.5 % plain ) ( B ) or general anaesthesia ( fentanyl , thiopentone , atracurium , enflurane , N2O/O2 ) ( C ) for hip surgery . ST segment monitoring was performed from the induction of anaesthesia and for the following 48 h , and perioperative hypotension , blood loss and fluid therapy were recorded . ST depression developed in two out of 14 ( A ) , seven out of 15 ( B ) and six out of 14 ( C ) patients ( P = 0.14 ) . In ( A ) , a total of seven ST depressions occurred in the observation period as opposed to 125 in ( B ) and 16 in ( C ) ( P ST depression only occurred in ( B ) . Three ( A ) , 33 ( B ) and 40 ( C ) hypotensive events were recorded ( P ST depression compared with 10 % of normotensive patients ( P bupivacaine were used as opposed to the fixed 2.5 mL dose in ( B ) ( P mortality was higher in ( B ) ( P mortality between the three groups . The incidence of hypotension and myocardial ischaemia was lowest in the group receiving incremental spinal anaesthesia",
"Fifty patients undergoing elective abdominal aortic surgery were r and omised to receive either combined epidural and general anaesthesia and postoperative epidural analgesia ( CEGA ) or general anaesthesia and postoperative intravenous morphine infusion ( GA ) . Prospect i ve data was collected in order to compare the two groups . This included intraoperative cardiovascular changes and postoperative complications . The use of intraoperative vasopressors was significantly higher in the CEGA group ( P intravenous glyceryl trinitrate was significantly lower ( P no significant difference between groups in regard to blood loss , volume replacement or in the number of patients requiring postoperative ventilation . Two patients in the CEGA group died postoperatively compared to one in the GA group ( not significant ) . There was no significant difference between groups in the total number or type of postoperative complications . Combining epidural anaesthesia with general anaesthesia altered intraoperative cardiovascular management but did not affect postoperative outcome",
"In a prospect i ve r and omized trial the effects of continuous peridural analgesia on gastrointestinal motility and the postoperative course was studied in 48 consecutive patients with elective colorectal resections . 24 patients had peridural analgesia ( PDA ) with bupivacaine while 24 patients received intravenous analgesia ( IVA ) with pentazocine . With PDA the first passage of flatus and faeces was significantly accelerated . PDA was not associated with an increased rate of anastomotic breakdown and there were no respiratory complications in the PDA group",
"Background The efficacy and effects of epidural analgesia compared with patient-controlled analgesia ( PCA ) have not been reported in patients undergoing major vascular surgery . We compared the effects of epidural bupivacaine-morphine with those of intravenous PCA morphine after elective infrarenal aortic surgery . Methods Forty patients classified as American Society of Anesthesiologists physical status 2 or 3 received general anesthesia plus postoperative PCA using morphine sulfate ( group PCA ; n = 21 ) or general anesthesia plus perioperative epidural morphine - bupivacaine ( group EPI ; n = 19 ) during a period of 48 h. During operation , EPI patients received 0.05 mg/kg epidural morphine and 5 ml 0.25 % bupivacaine followed by an infusion of 0.125 % bupivacaine with 0.1 % morphine ( 0.1 mg/ml ) ; group PCA received 0.1 mg/kg intravenous morphine sulfate . Continuous electrocardiographic monitoring ( V4 and V5 leads ) was performed from the night before surgery until 48 h afterward . Respiratory inductive plethysmographic data were recorded after tracheal extubation . Visual analog pain scores at rest and after movement were performed every 4 h after extubation . Results Nurse-administered intravenous morphine and time to tracheal extubation were less in group EPI , as were visual analog pain scores at rest and after movement from 20 to 48 h. Complications and the duration of intensive care unit and hospital stay were comparable . There was a similar , low incidence of postoperative apneas , slow respiratory rates , desaturation , and S-T segment depression . Conclusions Epidural morphine-bupivacaine is associated with reduced early postoperative intravenous opioid requirements , more rapid tracheal extubation , and superior analgesia after abdominal aortic surgery , with comparable respiratory effects"
] | 41162e64-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE The 2011 American Academy of Pediatrics attention-deficit/hyperactivity disorder ( ADHD ) guideline emphasizes monitoring and measuring outcomes of children diagnosed with ADHD ; however , recommendations for how to measure improvement are less clear . A long-term goal was to develop an outcome measure that assesses the quality of care for children with ADHD . As a first step in that process , we conducted a literature synthesis on the efficacy and effectiveness of guideline -recommended ADHD treatments on patient outcomes . METHODS A literature search was conducted in PubMed according to PRISMA protocol and using MeSH terms . US Preventive Services Task Force ( USPSTF ) criteria were used to assess the level of evidence . Studies of interest were published after 2002 and assessed prospect i ve ADHD improvement using recommended ADHD treatments . RESULTS The systematic review result ed in 35 studies . According to USPSTF criteria , included studies were level I ( n = 24 ) , level II-1 ( n = 1 ) , and level II-2 ( n = 10 ) and were rated as good ( n = 20 ) or fair ( n = 15 ) . DSM- criteria -based rating scales were used most frequently to measure ADHD treatment outcomes . All included treatments result ed in ADHD improvement . Regardless of outcome measure , tool , or treatment type , symptom reduction and improvement were relatively large , with mean percentage reductions ranging from 20 % to 86 % on ADHD-Behavior Rating Scales scales , with only 1 study with Effect sizes ranged from 0.15 to 4.57 . CONCLUSIONS On the basis of this literature review , a consistent pattern of improvement in pediatric ADHD patients ' core symptoms emerged across studies , study design s , and recommended treatment approaches . This evidence supports the notion that an improvement of core symptoms within 1 year could satisfy the requirements of an effective outcome measure , which should be further investigated | [
"The purpose of this study was to examine in a controlled trial the effects of atomoxetine on the management of attention deficit-hyperactivity disorder ( ADHD ) symptoms and functional impairments at school and at home . Participants were 153 children ( age 8 to 12 years ) diagnosed with attention-deficit hyperactivity disorder who were r and omized to double-blind treatment with either atomoxetine ( n = 101 ) or placebo ( n = 52 ) . Findings revealed significant improvements both for parent and teacher ratings of behavior for children receiving atomoxetine therapy . Children also were reported to evidence a trend toward better response to active medication than to placebo for health-related quality of life as rated by parents . No significant effects were revealed for the teacher ratings of academic productivity . Data were interpreted to provide support for the efficacy of atomoxetine on the symptoms associated with ADHD . The effects of atomoxetine on other functional outcomes including academic performance and health-related outcomes are of interest , albeit less compelling for this particular investigation , than for the effects on overt symptom display",
"BACKGROUND Despite the persistence of attention-deficit/hyperactivity disorder ( ADHD ) into adolescence , little is known about the efficacy and tolerability of stimulant medications in this age group . OBJECTIVE To report the results of a multisite controlled study among adolescents with ADHD evaluating the efficacy and tolerability of osmotic-release oral system ( OROS ) methylpheni date . DESIGN Adolescents ( N = 220 ) having a confirmed Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition diagnosis of ADHD underwent dose titration to identify dosages of OROS methylpheni date that improved symptoms to predefined criteria . Subjects successfully completing the dose titration phase ( n = 177 ) ( ie , tolerated and responded to treatment and adhered to the protocol ) were r and omized to receive 2 weeks ' treatment with their individualized dosage of OROS methylpheni date ( 18 , 36 , 54 , or 72 mg once daily ) or placebo . Treatment effectiveness was measured using investigator , parent , and adolescent assessment s of ADHD . RESULTS A significant reduction from baseline in the investigator-rated ADHD Rating Scale , the primary efficacy measure , was found with OROS methylpheni date treatment compared with placebo . Similar findings were noted with parent- and adolescent-report measures . Based on a Clinical Global Impression improvement subscale score of much or very much improved , 52 % of subjects in the OROS methylpheni date group improved compared with 31 % receiving placebo . Thirty-seven percent of subjects required the maximum dosage of 72 mg/d . The incidence of drug-related adverse events was similar between the 2 study groups . CONCLUSION In adolescents , once-daily OROS methylpheni date significantly reduced ADHD symptoms and was well tolerated using dosages up to 72 mg/d",
"INTRODUCTION Lisdexamfetamine dimesylate ( LDX ) , a prodrug stimulant , is indicated for attention-deficit/hyperactivity disorder ( ADHD ) in children 6 - 12 years of age and in adults . In short-term studies , once-daily LDX provided efficacy throughout the day . This study presented here was conducted to assess the long-term safety , tolerability , and effectiveness of LDX in 6- to 12-year-olds with ADHD . METHODS This open-label , multicenter , single-arm study enrolled children with Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition-Text Revision criteria for ADHD . Following 1-week screening and washout periods , subjects were titrated to LDX 30 , 50 , or 70 mg/day over 4 weeks and placed on maintenance treatment for 11 months . The ADHD Rating Scale and Clinical Global Impression-Improvement scale measured effectiveness . RESULTS Of 272 subjects receiving LDX , 147 completed the study . Most adverse events were mild to moderate and occurred during the first 4 weeks . There were no clinical ly meaningful changes in blood pressure or electrocardiographic parameters . From baseline to endpoint , mean ADHD Rating Scale scores improved by 27.2 points ( P Clinical Global Impression-Improvement scale scores , > 80 % of subjects at endpoint and > 95 % of completers at 12 months were rated \" improved . \" CONCLUSION Long-term 30 , 50 , and 70 mg/day LDX was generally well tolerated and effective in children with ADHD",
"OBJECTIVE To test the hypotheses that in children with attention-deficit/hyperactivity disorder ( ADHD ) ( 1 ) symptoms of ADHD , oppositional defiant disorder , and overall functioning are significantly improved by methylpheni date combined with intensive multimodal psychosocial treatment compared with methylpheni date alone and with methylpheni date plus attention control and ( 2 ) more children receiving combined treatment can be taken off methylpheni date . METHOD One hundred three children with ADHD ( ages 7 - 9 ) , free of conduct and learning disorders , who responded to short-term methylpheni date were r and omized for 2 years to ( 1 ) methylpheni date alone ; ( 2 ) methylpheni date plus psychosocial treatment that included parent training and counseling , social skills training , psychotherapy , and academic assistance , or ( 3 ) methylpheni date plus attention psychosocial control treatment . Assessment s included parent , teacher , and psychiatrist ratings , and observations in academic and gym classes . RESULTS Combination treatment did not lead to superior functioning and did not facilitate methylpheni date discontinuation . Significant improvement occurred across all treatments and continued over 2 years . CONCLUSIONS In stimulant-responsive children with ADHD , there is no support for adding ambitious long-term psychosocial intervention to improve ADHD and oppositional defiant disorder symptoms . Significant benefits from methylpheni date were stable over 2 years",
"OBJECTIVE The efficacy and safety of dexmethylpheni date extended release ( d-MPH-ER ) was compared to placebo in pediatric patients with attention-deficit/hyperactivity disorder ( ADHD ) . METHOD This multicenter , r and omized , double-blind , placebo-controlled , parallel-group , two-phase study included 97 patients ( ages 6 - 17 years ) with DSM-IV-defined ADHD . The study was carried out between 2001 and 2003 . After a 2-week evaluation phase , patients were r and omized to d-MPH-ER or placebo for 7 weeks . Flexible d-MPH-ER dosing ( 30 mg/day ) was permitted for 5 weeks , then patients remained on their optimal dose during the last 2 study weeks . The primary efficacy measure was change from baseline to final rating in Conners ADHD/DSM-IV Scale-Teacher version ( CADS-T ) total subscale score . Secondary efficacy variables included changes from baseline to final visit in CADS-T Inattentive and Hyperactive-Impulsive subscale scores , CADS-P DSM-IV total subscale score and Inattentive and Hyperactive-Impulsive subscale scores , Clinical Global Impressions-Improvement ( CGI-I ) and CGI-Severity ( CGI-S ) scale scores , and Child Health Question naire Parent Form 50 scores . RESULTS d-MPH-ER improved CADS-T total scores significantly compared with placebo ( p d-MPH-ER patients were rated much improved or very much improved on CGI-I at final visit versus 13.3 % of placebo patients ( p d-MPH-ER ( 49.1 % ) than placebo ( 25.5 % ) spontaneously reported adverse events suspected as drug related . CONCLUSIONS Once-daily d-MPH-ER was more effective than placebo in the treatment of ADHD in children and adolescents",
"Objective : To review the primary and secondary findings from the Multimodal Treatment study of ADHD ( MTA ) published over the past decade as three sets of articles . Method : In a two-part article — Part I : Executive Summary ( without distracting details ) and Part II : Supporting Details ( with additional background and detail required by the complexity of the MTA)—we address confusion and controversy about the findings . Results : We discuss the basic features of the gold st and ard used to produce scientific evidence , the r and omized clinical trial , for which was used to contrast four treatment conditions : medication management alone ( MedMgt ) , behavior therapy alone ( Beh ) , the combination of these two ( Comb ) , and a community comparison of treatment “ as usual ” ( CC ) . For each of the three assessment points we review three areas that we believe are important for appreciation of the findings : definition of evidence from the MTA , interpretation of the serial presentations of findings at each assessment point with a different definition of long-term , and qualification of the interim conclusions about long-term effects of treatments for ADHD . Conclusion : We discuss the possible clinical relevance of the MTA and present some practical suggestions based on current knowledge and uncertainties facing families , clinicians , and investigators regarding the long-term use of stimulant medication and behavioral therapy in the treatment of children with ADHD . ( J. of Att . Dis . 2008 ; 12(1 ) 4 - 14",
"OBJECTIVE Clinical experience suggests that some ( but not all ) patients with attention-deficit/hyperactivity disorder ( ADHD ) are highly responsive to the nonstimulant atomoxetine . We conducted a retrospective analysis of r and omized controlled trials ( RCTs ) to identify potential baseline ( moderator ) and on-treatment ( mediator ) predictors of responses . METHOD Data from 6 U.S. RCTs among patients aged 6 to 18 years were pooled ( N = 1,069 ; subjects treated with atomoxetine , n = 618 ) . Subjects were categorized as much improved ( > or = 40 % decrease in ADHD Rating Scale-IV-Parent Version : Investigator Administered and Scored total score ) , minimally improved ( 25%- regression , analyses of variance , and repeated- measures analyses were used to explore associations between baseline and on-treatment variables , achieving a much improved response at trial endpoint ( 6 - 9 weeks ) . RESULTS Forty-seven percent of patients showed a much improved clinical response , and 40 % did not respond . Only 13 % of the patients had a minimal response . No baseline characteristics predicted achieving a much improved clinical response ; the only predictor of achieving this response was being at least minimally improved by treatment week 4 ( sensitivity = 81 % , specificity = 72 % , positive predictive value = 75 % , and negative predictive value = 79 % ) . CONCLUSIONS Clinical response to atomoxetine was bimodal , with most subjects being either responders who were much improved or nonresponders . There were no demographic or clinical predictors of response . However , subjects who ultimately achieved a much improved response were likely to be at least minimal responders by week 4 . The recommendation to consider either augmenting or switching treatment in patients who do not achieve at least this level of response to atomoxetine by 4 weeks offers a method for limiting the extended duration of titration to subjects who are most likely to benefit further , while minimizing the duration of exposure in those less likely to achieve an excellent response",
"INTRODUCTION This study compared two atomoxetine titration dosing schedules and two atomoxetine maintenance doses for treating adolescent attention-deficit/hyperactivity disorder ( ADHD ) inattention and hyperactivity/impulsivity . METHODS Adolescents ( N = 267 ) were r and omized to a slow or fast titration schedule . Patients who responded continued on a 40-week maintenance treatment , r and omized to either 0.8 or 1.4 mg/kg/day . RESULTS During the acute period , significant benefit was demonstrated with both titration schedules on the ADHD Rating Scale total score . Although patients in both groups maintained benefit relative to week 0 , statistically significant loss of benefit was found for patients maintained on 0.8 mg/kg/day but not on 1.4 mg/kg/day . A similar pattern was observed on the Clinical Global Impressions-ADHD-Severity scores and Life Participation Scale for ADHD-Child Version scores . Mean grade s for most subjects improved for patients in both maintenance treatment groups although most improvements were not statistically significant . CONCLUSIONS In adolescents with ADHD , treatment benefit at 8 weeks was better maintained long-term with 1.4 mg/kg/day than with 0.8 mg/kg/day . Improvement in adaptive functioning and age-appropriate developmental function was also demonstrated . Atomoxetine 0.8 and 1.4 mg/kg/day were equally well tolerated . CLINICAL TRIALS REGISTRY Maintenance of benefit with atomoxetine hydrochloride in adolescents with ADHD , NCT00191035",
"OBJECTIVES This report presents both age-adjusted and unadjusted statistics from the 2009 National Health Interview Survey ( NHIS ) on selected health measures for children under age 18 , classified by sex , age , race , Hispanic origin , family structure , parent education , family income , poverty status , health insurance coverage , place of residence , region , and current health status . The topics covered are asthma , allergies , learning disability , attention deficit hyperactivity disorder ( ADHD ) , prescription medication use , respondent-assessed health status , school days missed due to illness or injury , usual place of health care , time since last contact with a health care professional , selected measures of health care access and utilization , and dental care . New in 2009 - - Data on food and skin allergies , previously combined in \" other allergies , \" are presented separately in this report . DATA SOURCE NHIS is a multistage probability sample survey conducted annually by interviewers of the U.S. Census Bureau for the Centers for Disease Control and Prevention 's National Center for Health Statistics and is representative of the civilian noninstitutionalized population of the United States . Data are collected for all family members during face-to-face interviews with adults present at the time of interview . Additional information about children is collected for one r and omly selected child per family in face-to-face interviews with an adult proxy respondent familiar with the child 's health . SELECTED HIGHLIGHTS In 2009 , most U.S. children aged 17 and under had excellent or very good health ( 84 % ) . However , 8 % of children had no health insurance coverage , and 5 % of children had no usual place of health care . Fourteen percent of children had ever been diagnosed with asthma . An estimated 8 % of children aged 3 - 17 had a learning disability , and an estimated 9 % of children had ADHD",
"OBJECTIVE . With this study we assessed the efficacy and safety of an extended-release formulation of guanfacine compared with placebo for the treatment of children and adolescents with attention-deficit/hyperactivity disorder . METHODS . In this multicenter , double-blind , placebo-controlled , fixed-dosage escalation study , patients aged 6 to 17 years were r and omly assigned to 1 of 3 treatment groups of guanfacine extended release ( 2 , 3 , or 4 mg/day ) or placebo for 8 weeks . The primary outcome measurement was the Attention-Deficit/Hyperactivity Disorder Rating Scale IV total score . Secondary measurements included Clinical Global Impression of Improvement , Parent 's Global Assessment , Conners ' Parent Rating Scale – Revised : Short Form , and Conners ' Teacher Rating Scale – Revised : Short Form . RESULTS . A total of 345 patients were r and omly assigned to placebo ( n = 86 ) or guanfacine extended release 2 mg ( n = 87 ) , 3 mg ( n = 86 ) , or 4 mg ( n = 86 ) treatment groups . Least-squares mean changes from baseline to the end point in Attention-Deficit/Hyperactivity Disorder Rating Scale IV total scores were significant in all groups of children taking guanfacine extended release : −16.18 in the 2-mg group , −16.43 in the 3-mg group , and −18.87 in the 4-mg group , compared with −8.48 in the placebo group . All groups of children taking guanfacine extended release showed significant improvement on hyperactivity/impulsivity and inattentiveness subscales of the Attention-Deficit/Hyperactivity Disorder Rating Scale IV , Clinical Global Impression of Improvement , Parent 's Global Assessment , Conners ' Parent Rating Scale – Revised : Short Form , and Conners ' Teacher Rating Scale – Revised : Short Form assessment s compared with placebo . The most commonly reported treatment-emergent adverse events were headache , somnolence , fatigue , upper abdominal pain , and sedation . Small to modest changes in blood pressure , pulse rate , and electrocardiogram parameters were observed but were not clinical ly meaningful . CONCLUSIONS . Guanfacine extended release met the primary and secondary efficacy end points . It was well tolerated and effective compared with placebo",
"OBJECTIVES d , l-threo-methylpheni date HCl ( D , L-MPH ) is the most common treatment of attention deficit hyperactivity disorder ( ADHD ) . A previous report showed placebo-controlled efficacy for the purified d-isomer ( dexmethylpheni date hydrochloride , d-MPH , Focalin ) with a 2:1 potency compared to dl , and suggested a 6-hour duration of action . This study complements that report by study ing the effect of placebo-controlled discontinuation and retesting the duration of action . METHODS A 6-week , open-label titration of d-MPH ( 2.5 - 10 mg twice-a-day ) was followed by a double-blind , placebo-controlled , 2-week withdrawal study of responders . RESULTS In the open titration , 82 % of the 89 enrolled patients achieved a Clinical Global Impression-Improvement ( CGI-I ) rating of much or very much improved . Only 5 patients discontinued for adverse events . Seventy-five patients continued into the placebo-controlled discontinuation . For the r and omly assigned d-MPH ( n=35 ) and placebo ( n=40 ) groups , mean ages , respectively , were 10.1 + /- 2.9 and 9.9 + /- 2.7 years , 86 % and 78 % were male , and 70.6 % and 80.0 % took the ceiling dose of 10 mg twice-daily , respectively . Each group had 80 % combined type ADHD and 20 % inattentive type . By the end of the 2-week , placebo-masked withdrawal , significantly more placebo patients ( 24 of 39 ) than d-MPH continuers ( 6 of 35 ) relapsed ( 61.5 % versus 17.1 % , p=0.001 ) . Compared to d-MPH continuers , placebo patients deteriorated significantly more in the 2-week period on teacher ratings of the 18 ADHD symptoms rated 0 - 3 ( p=0.028 ) , the 3 p.m. and 6 p.m. parent ADHD symptom ratings ( p=0.0026 and p=0.0381 , respectively ) , and clinic ( 2 - 3 p.m. ) and home ( 6 p.m. ) Math Tests ( p=0.024 and p d-MPH is safe , tolerable , and effective , with a 6-hour duration of effect suggested by the significant difference from placebo at 6 hours on a double-blind discontinuation",
"OBJECTIVE This study compared the efficacy of guanfacine extended release ( GXR ) , a selective alpha(2A)-adrenoceptor agonist , with placebo in children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) . METHOD This double-blind , 9-week , dose-ranging , parallel- design , multicenter trial r and omized 6- to 17-year-olds with ADHD to once-daily oral GXR in 1- , 2- , 3- , and 4-mg doses or placebo . Primary outcome was change in total ADHD Rating Scale-IV score from baseline to endpoint . Secondary outcomes included changes in scores of hyperactive/impulsive and inattentive subscales ; clinician and parent ratings ; duration of clinical effect ; and safety measures . RESULTS Statistically significant reductions in ADHD Rating Scale-IV scores were observed from baseline to endpoint at all doses of GXR , with effect sizes ranging from 0.43 to 0.62 . In subjects receiving GXR , mean heart rate and systolic and diastolic blood pressure decreased as the dose of GXR increased and then returned toward baseline during the dose-maintenance and dose-tapering phases of the trial . Most frequent treatment-emergent adverse events ( > or = 5 % ) were somnolence , headache , fatigue , sedation , dizziness , irritability , upper abdominal pain , and nausea . Somnolence , sedation , and fatigue adverse events emerged within the first 2 weeks of dosing and generally resolved by study end . CONCLUSIONS : Guanfacine extended-release was effective in reducing symptoms of ADHD . Adverse events were mild to moderate , did not interfere with improvements in attention , and rarely led to discontinuation",
"OBJECTIVE The aim of this study was to assess the effectiveness and safety of lisdexamfetamine dimesylate ( LDX ) in children with attention-deficit/hyperactivity disorder ( ADHD ) . METHOD This was a 7-week , open-label study evaluating 20 , 30 , 40 , 50 , 60 , or 70 mg/day LDX in 318 children aged 6 - 12 years with ADHD . The ADHD Rating Scale IV ( ADHD-RS-IV ) was the primary efficacy assessment . Secondary measures included the Clinical Global Impressions-Improvement ( CGI-I ) , Expression and Emotion Scale for Children ( EESC ) , and Behavior Rating Inventory of Executive Function ( BRIEF ) . Safety assessment s included treatment-emergent adverse events ( TEAEs ) , vital signs , and electrocardiograms . RESULTS At end point , mean ( st and ard deviation [ SD ] ) improvement from baseline in ADHD-RS-IV total score was 28.6 ( 10.9 ) ( p EESC total and subscale scores ( p Global Executive Composite , Behavioral Regulation , and Metacognition indices of the BRIEF ( p or = 10 % ) were decreased appetite , decreased weight , irritability , insomnia , headache , upper abdominal pain , and initial insomnia . CONCLUSIONS LDX was effective and generally well tolerated with a safety profile consistent with long-acting stimulant use . There was overall improvement in ADHD symptoms and executive function measures and no worsening of emotional expression measures . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00500071",
"OBJECTIVE : To assess the efficacy and safety of clonidine hydrochloride extended-release tablets ( CLON-XR ) combined with stimulants ( ie , methylpheni date or amphetamine ) for attention-deficit/hyperactivity disorder ( ADHD ) . PATIENTS AND METHODS : In this phase 3 , double-blind , placebo-controlled trial , children and adolescents with hyperactive- or combined-subtype ADHD who had an inadequate response to their stable stimulant regimen were r and omized to receive CLON-XR or placebo in combination with their baseline stimulant medication . Predefined efficacy measures evaluated change from baseline to week 5 . Safety was assessed by spontaneously reported adverse events , vital signs , electrocardiogram recordings , and clinical laboratory values . Improvement from baseline for all efficacy measures was evaluated using analysis of covariance . RESULTS : Of 198 patients r and omized , 102 received CLON-XR plus stimulant and 96 received placebo plus stimulant . At week 5 , greater improvement from baseline in ADHD Rating Scale IV ( ADHD-RS-IV ) total score ( 95 % confidence interval : −7.83 to −1.13 ; P = .009 ) , ADHD-RS-IV hyperactivity and inattention subscale scores ( P = .014 and P = .017 , respectively ) , Conners ' Parent Rating Scale scores ( P Clinical Global Impression of Severity ( P = .021 ) , Clinical Global Impression of Improvement ( P = .006 ) , and Parent Global Assessment ( P = .001 ) was observed in the CLON-XR plus stimulant group versus the placebo plus stimulant group . Adverse events and changes in vital signs in the CLON-XR group were generally mild . CONCLUSIONS : The results of this study suggest that CLON-XR in combination with stimulants is useful in reducing ADHD in children and adolescents with partial response to stimulants",
"Objective : To review and provide details about the primary and secondary findings from the Multimodal Treatment study of ADHD ( MTA ) published during the past decade as three sets of articles . Method : In the second of a two part article , we provide additional background and detail required by the complexity of the MTA to address confusion and controversy about the findings outlined in part I ( the Executive Summary ) . Results : We present details about the gold st and ard used to produce scientific evidence , the r and omized clinical trial ( RCT ) , which we applied to evaluate the long-term effects of two well-established unimodal treatments , Medication Management ( MedMGT ) and behavior therapy ( Beh ) , the multimodal combination ( Comb ) , and treatment “ as usual ” in the community ( CC ) . For each of the first three assessment points defined by RCT methods and included in intent-to-treat analyses , we discuss our definition of evidence from the MTA , interpretation of the serial presentations of findings at each assessment point with a different definition of long-term varying from weeks to years , and qualification of the interim conclusions about long-term effects of treatments for ADHD based on many exploratory analyses described in additional published articles . Conclusions : Using a question and answer format , we discuss the possible clinical relevance of the MTA and present some practical suggestions based on current knowledge and uncertainties facing families , clinicians , and investigators regarding the long-term use of stimulant medication and behavioral therapy in the treatment of children with ADHD . ( J. of Att . Dis . 2008 ; 12(1 ) 15 - 43",
"BACKGROUND Data on the management of attention-deficit/hyperactivity disorder ( ADHD ) in African-American children and adolescents are limited . METHODS This study sought to evaluate the tolerability , safety , and efficacy of atomoxetine hydrochloride in the management of ADHD in African-American children and adolescents by conducting a post hoc subgroup analysis of 2 multicenter , open-label studies . RESULTS Atomoxetine was safe and well tolerated , with > or=3.0 % of African-Americans and Caucasians discontinuing treatment because of adverse events . A significantly higher proportion of Caucasians reported > or=1 treatment-emergent adverse event , including vomiting ( 7.2 % vs 1.2 % ; P=.037 ) and fatigue ( 6.1 % vs 0 % ; P=.012 ) . No serious safety concerns were observed . Changes from baseline in height , weight , and hemodynamic variables were modest and similar in both racial subgroups . African-Americans and Caucasians showed significant improvement from baseline to end point in the mean ADHD Rating Scale-IV-Parent Version : Investigator Administered and Scored ( ADHDRS-IV-P : I ) . Scores decreased by 20.1 in African-Americans and by 19.55 in Caucasians , without significant between-group differences . Patients in both racial groups experienced similar , significant improvements in ADHDRS-IV-P : I inattention and hyperactivity-impulsivity symptoms , Clinical Global Impression-ADHD-Severity , and Conners ' Parent Rating Scale-Revised : Short Form . CONCLUSIONS Atomoxetine exhibited similar tolerability , safety , and efficacy profiles in African-Americans and Caucasians with ADHD",
"BACKGROUND This pilot study examined the efficacy and duration of the effect of dexmethylpheni date ( d-MPH ) given once-daily in subjects with attention deficit hyperactivity disorder ( ADHD ) . METHOD Subjects aged 6 - 18 years ( inclusive ) with ADHD were enrolled in this 8-week , openlabel study . Outcome measures included the Conners'Teacher and Parent Rating Scales , the Attention Deficit Disorder Rating Scale ( ADDRS ) , the Clinical Global Impression ( CGI ) Scale , and teacher and parent visual analog scales to estimate the duration of efficacy . d-MPH was initiated at a dose of 2.5 mg/day . The dose was flexible , based on response and tolerability , and could be increased in increments of 2.5 mg/day to a maximum daily dose of 30 mg/day . RESULTS Twenty-two subjects ( mean age , 8.7 + /- 0.4 years ) were treated . Significant improvements ( p Conners ' Teacher and Parent Rating Scales after 8 weeks . Of the evaluated subjects , 85.7 % ( 18 of 21 ) showed at least a 30 % improvement from baseline on the Conners ' Teacher Rating Scale , and 86.4 % ( 19 of 22 ) of subjects showed at least a 30 % improvement from baseline on the Conners ' Parent Rating Scale . Most subjects demonstrated an improvement on the ADDRS and the CGI-Improvement ( CGI-I ) scale . Median duration of effect was estimated at 6.2 hours ( teachers ) and at 7.5 hours ( parents ) . On average , patients gained 2.4 pounds over the course of the study . CONCLUSIONS A single daily dose of d-MPH was effective in controlling ADHD in children and was well tolerated . Future studies are needed to confirm these findings and to evaluate chronic dosing with d-MPH",
"BACKGROUND The primary treatment for attention-deficit/hyperactivity disorder ( ADHD ) has been psychostimulants . Recently developed nonpsychostimulant treatments have allowed certain patients to switch from a psychostimulant to a nonpsychostimulant . However , the outcomes of such switches have not been systematic ally studied . OBJECTIVE The purpose of this pilot study was to assess treatment tolerance and efficacy during a cross-taper transition from methylpheni date or amphetamine to atomoxetine among children and adolescents with ADHD . METHODS This pilot study was conducted in patients ( aged 6 - 17 years ) with incomplete responses ( failure to obtain full reduction/elimination of symptoms ) or intolerance of adverse events ( AEs ) during psychostimulant treatment . Patients continued ongoing psychostimulant treatment during the first week of the study . Transition to atomoxetine began by administering atomoxetine 0.5 mg/kg . d plus full-dose psychostimulant for 1 week , followed in the second week by 1.2 mg/kg . d atomoxetine plus half-dose psychostimulant . Patients remained on 1.2 mg/kg . d atomoxetine monotherapy for the remaining 5 weeks . This stepwise transition was enacted due to the difference in pharmacodynamics between the psychostimulants and atomoxetine . Applying a stepwise cross-titration allowed for better control of ADHD symptoms during the intervening period . Change in ADHD symptoms , as measured by the mean change in the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Parent Version : Investigator-administered and -scored ( ADHDRS-IV-Parent : Inv ) , was assessed from baseline to end point . RESULTS Of the 62 subjects enrolled in the study , 39 ( 62.9 % ) were diagnosed as ADHD-combined type . Similar proportions were receiving methylpheni date ( 51.6 % ) and amphetamine ( 48.4 % ) . Slightly more wished to switch due to inadequate response ( 53.2 % ) than intolerability ( 46.8 % ) . Nine subjects discontinued at various times during the course of the study ( patient or parent/caregiver decision [ 4 ] , AE [ 2 ] , protocol violation [ 2 ] , and lack of efficacy [ 1 ] ) . Mean ( SD ) ADHDRS-IV-Parent : Inv total scores ( n = 59 , last-observation-carried-forward ) improved significantly from baseline ( visit 2 ) to an end point ( 32.1 [ 10.5 ] vs 22.6 [ 14.0 ] ; P 58 subjects answering in the atomoxetine monotherapy phase , 38 ( 65.5 % ) reported a preference for atomoxetine treatment over their previous psychostimulant . Tolerability results were as follows : 26 ( 44.1 % ) of 59 patients reported > or=1 AE , the most common being somnolence ( 4 [ 6.8 % ] ) , fatigue ( 3 [ 5.1 % ] ) , decreased appetite ( 3 [ 5.1 % ] ) , cough ( 3 [ 5.1 % ] ) , headache ( 3 [ 5.1 % ] ) , and contact dermatitis ( 2 [ 3.4 % ] ) . No clinical ly severe AEs were reported . Both mean ( SD ) diastolic ( 2.4 [ 7.8 ] mm Hg ; P = 0.031 ) and systolic ( 2.4 [ 7.9 ] mm Hg ; P = 0.029 ) blood pressures increased significantly from baseline to end point . Electrocardiography revealed a significant increase in mean ( SD ) heart rate ( 9.2 [ 11.6 ] bpm ; P decrease in mean ( SD ) RR interval ( -77.8 [ 98.2 ] ms ; P increases in diastolic pressure and heart rate were observed . CONCLUSION These children and adolescent patients were successfully switched from methylpheni date or amphetamine to atomoxetine treatment , with result ing improvement in ADHD symptom severity from baseline in this pilot study",
"Purpose : The study aims to assess the changes in attitudes and practice s about ADHD reported by AAP fellows between 1999 and 2005 during which AAP ADHD guidelines , training , and quality improvement initiatives occurred . Method : The study assesses AAP-initiated surveys that were conducted between 1999 and 2005 and involving a r and om sample of 1,000 and 1,603 pediatricians , respectively . Results : The findings reveal that significant , although modest , increases occurred in pediatric practitioners ’ self-reported adherence to the guidelines . About 81 % of respondents reported routine use of formal diagnostic criteria ( up from 67 % ) , and 67 % of the respondents routinely use ADHD teacher rating scales ( compared to 49 % in the 1999 survey ) . Findings further reveal that treatment with stimulant medications was used extensively by pediatricians from both surveys ; more pediatricians in the 2005 survey reported use of a second stimulant if the first did not work , and still more reported almost always providing parent training , although the estimated number remained only about a quarter of the total ; and greater familiarity with the initiatives predicted better reported adherence to the guidelines . Conclusion : The reported behaviors of practitioners have moved in the direction of greater adherence with the recommended AAP ADHD guidelines , and there was a positive response to , and a greater use of , the material s developed to enhance practice . The authors infer that practice changes may be due to many factors , including AAP guidelines and associated implementation efforts . Changing physician practice s needs to be sustained through a continuing process that requires multiple , varying , sustained efforts directed at physicians , other providers , and families"
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The aim of this systematic review was to collect all available r and omized controlled trials on the effect of folate supplementation on folate status and health outcomes within the paediatric age group . The method included a structured search strategy on MEDLINE , Embase and Cochrane data bases , with formal inclusion /exclusion criteria and data extraction procedure . We included 26 studies . We conclude that both serum and erythrocyte folate values reflect folate intake ; however , serum folate reacts more rapidly to folate intake than erythrocyte folate . As to health outcomes , we found no evidence indicating that additional intake of folate can influence haematological parameters in non-anaemic paediatric patients . We were unable to find evidence of a favourable effect of folate supplementation on the growth of infants . However , the limited data available suggest that supplementing the diet of low-birth-weight infants with folic acid may moderate the rapid fall of serum and red cell folate in the first months of life | [
"Background Anemia continues to be a major public health problem among children in many regions of the world , and it is still not clear which strategy to treat it is most effective . Objective To evaluate the efficacy and children 's acceptance of several recognized strategies to treat anemia . Methods Non-breastfed children ( n = 577 ) , 6 to 43 mo of age , were screened for the trial ; 267 were anemic ( hemoglobin 1 of 5 treatments to received daily either : an iron supplement ( IS ) , an iron+folic acid supplement ( IFS ) , a multiple micronutrient supplement ( MMS ) , a micronutrient-fortified complementary food as porridge powder ( FCF ) , or zinc+iron+ascorbic acid fortified water ( FW ) . The iron content of each daily dose was 20 , 12.5 , 10 , 10 and 6.7 mg respectively . Hemoglobin ( Hb ) , ferritin , total iron , weight and height were measured at baseline and after 4 months of treatment . Morbidity , treatment acceptability and adherence were recorded during the intervention . Results All treatments significantly increased Hb and total iron concentration ; ferritin did not change significantly . Groups MMS , IS and IFS increased Hb ( g/dL ) [ 1.50 ( 95%CI : 1.17 , 1.83 ) , 1.48 [ ( 1.18 , 1.78 ) and 1.57 ( 1.26 , 1.88 ) , respectively ] and total iron ( ( μg/dL ) [ 0.15 ( 0.01 , 0.29 ) , 0.19 ( 0.06 , 0.31 ) and 0.12(-0.01 , 0.25 ) , respectively ] significantly more than FCF [ 0.92 ( 0.64 , 1.20 ) ] but not to FW group [ 0.14 ( 0.04 , 0.24 ) ] . The prevalence of anemia was reduced to a greater extent in the MMS and IFS groups ( 72 % and 69 % , respectively ) than in the FCF group ( 45 % ) ( p significant differences in anthropometry or in the number of episodes of diarrhea and respiratory infections among treatment groups . The supplements MMS and IS were less acceptable to children , than IFS , FCF and FW . Conclusion The three supplements IS , ISF and MMS increased Hb more than the FCF ; the supplements that contained micronutrients ( IFS and MMS ) were more effective for reducing the prevalence of anemia . In general , fortified foods were better accepted by the study participants than supplements . Clinical Trial.gov",
"Objective : Gingival overgrowth is an important adverse effect of phenytoin ( PHT ) therapy , occurring in about half of the patients . This study aim ed to evaluate the effect of oral folic acid supplementation ( 0.5 mg/day ) for the prevention of PHT-induced gingival overgrowth ( PIGO ) in children with epilepsy aged 6–15 years on PHT monotherapy for 6 months . Methods : This was a r and omized , double-blind , placebo-controlled trial conducted at a tertiary level hospital from May 2008 to June 2009 . Children aged 6–15 years started on PHT monotherapy within last 1 month were eligible for inclusion . Preexisting gingival overgrowth , use of other folic acid antagonists , and macrocytic anemia were exclusion criteria . Trial subjects were r and omized to receive either folic acid or placebo . The primary outcome measure was incidence of any degree of gingival overgrowth after 6 months of PHT monotherapy . The trial was registered with clinical trials.gov ( NCT00781196 ) . Results : A total of 120 children were recruited , 62 and 58 , respectively , in folic acid and placebo arms . The 2 arms were comparable at baseline . Twenty-one percent of patients in the folic acid arm developed PIGO , as compared with 88 % receiving placebo ( p . Absolute risk reduction of PIGO by folic acid was 67 % ( 95 % confidence interval 54%–80 % ) , and relative risk reduction was 0.76 . Conclusions : Oral folic acid was found to decrease the incidence of PIGO in children on PHT monotherapy , in a statistically significant and clinical ly relevant manner . Classification of evidence : This study provides Class I evidence that folic acid supplementation , 0.5 mg/day , is associated with prevention of gingival overgrowth in children taking PHT monotherapy",
"Background Seven genes involved in folate metabolism are located on chromosome 21 . Previous studies have shown that folate deficiency may contribute to mental retardation in Down 's syndrome ( DS ) . Methodology We investigated the effect of oral folate supplementation ( daily dose of 1.0±0.3 mg/kg ) on cognitive functions in DS children , aged from 3 to 30 months . They received 1 mg/kg leucovorin or placebo daily , for 12 months , in a single-centre , r and omised , double-blind study . Folinic acid ( leucovorin , LV ) was preferred to folic acid as its bioavailability is higher . The developmental age ( DA ) of the patients was assessed on the Brunet-Lezine scale , from baseline to the end of treatment . Results The intent-to-treat analysis ( 113 patients ) did not show a positive effect of leucovorin treatment . However , it identified important factors influencing treatment effect , such as age , sex , and concomitant treatments , including thyroid treatment in particular . A per protocol analysis was carried out on patients evaluated by the same examiner at the beginning and end of the treatment period . This analysis of 87 patients ( 43 LV-treated vs. 44 patients on placebo ) revealed a positive effect of leucovorin on developmental age ( DA ) . DA was 53.1 % the normal value with leucovorin and only 44.1 % with placebo ( p of leucovorin was particularly strong in patients receiving concomitant thyroxin treatment ( 59.5 % vs. 41.8 % , p No adverse event related to leucovorin was observed . Conclusion These results suggest that leucovorin improves the psychomotor development of children with Down 's syndrome , at least in some subgroups of the DS population , particularly those on thyroxin treatment . Trial Registration Clinical Trials.gov ,",
" One hundred eighty-four premature infants , entered into a study investigating the role of additional folate and vitamin B-12 supplementation of the anemia of prematurity . All patients initially received vitamin E and iron in accordance with accepted st and ards . Patients were r and omly assigned to four groups to receive orally 0.1 mg folate/d for 4 mo , 100 micrograms vitamin B-12 intramuscularly monthly for 4 mo , both supplements , or neither . All other activities including parenteral nutrition were carried out according to established practice s , irrespective of study group . By 10 - 12 wk , infants treated with vitamin B-12 alone or combined with folate had higher hemoglobin values than the untreated ( P selenium , showed a similar pattern of decline for 10 - 12 wk in all study patients , whether or not they received additional vitamin supplements",
"Background —Accelerated vascular disease is common in chronic renal failure ( CRF ) and accounts for significant mortality and morbidity . Elevated homocysteine levels may contribute by an effect on endothelial function . Methods and Results —We performed a double-blind placebo-controlled r and omized crossover trial of folic acid at 5 mg/m2 in 25 normotensive children 12±3 ( 7 to 17 ) years of age with CRF ( glomerular filtration rate 26.8±13.2 mL/min per 1.73 m2 ) of noninflammatory etiology . Each subject underwent two 8-week periods of folic acid and placebo separated by an 8-week washout period . The effect of folic acid on homocysteine levels , LDL oxidation , and both endothelial-dependent and -independent vascular function were measured . After oral folic acid , serum folate levels rose from 11.7±4.25 to 635±519 & mgr;g/L ( P = 0.001 ) , red cell folate levels rose from 364±195 to 2891±2623 & mgr;g/L ( P ) , and total homocysteine levels fell from 10.28±4.16 to 8.62±2.32 & mgr;mol/L ( P = 0.03 ) . In addition , there was a significant improvement in flow-mediated dilatation ( FMD ) ( endothelial-dependent dilatation ) from 7.21±2.8 % to 8.47±3.01 % ( P = 0.036 ) with no change in response to glyceryl trinitrate ( endothelial-independent dilatation ) . There was no significant change in FMD or glyceryl trinitrate during the placebo phase . There was , however , no significant difference in final FMD after placebo or folic acid . Lag times for LDL oxidation were prolonged during the treatment phase ( 58.4±18.7 to 68.1±25.9 minutes , P = 0.01 ) . Conclusion —Folic acid supplementation in children with CRF may improve endothelial function with an increased resistance of LDL to oxidation ",
"Abstract Hyperhomocysteinemia is emerging as an independent predictor of cardiovascular disease and hypertension among children . The aim of the study was to examine the effects of oral folic acid on homocysteine and blood pressure . Folic acid supplementation has been found to reduce homocysteine levels and in some cases blood pressure . Five hundred and twenty children participated in the study , and 26 of them were found to be hyperhomocysteinemic ; 20 of these children r and omly received 5 mg oral folic acid supplement while the other six children were the controls . Serum homocysteine ( P levels as well as systolic ( P and diastolic ( P = 0.045 ) blood pressure were statistically significantly decreased in the intervention group compared with the controls , while folic acid levels were statistically significantly increased ( P Total serum homocysteine levels were correlated with age , serum folate , body mass index , and blood pressure . It appears that folic acid may be a safe and effective supplement to reduce homocysteine and possibly blood pressure , which consequently may prevent cardiovascular disease in children in early life",
"Objectives To assess whether supplementation with antioxidants , folinic acid , or both improves the psychomotor and language development of children with Down ’s syndrome . Design R and omised controlled trial with two by two factorial design . Setting Children living in the Midl and s , Greater London , and the south west of Engl and . Participants 156 infants aged under 7 months with trisomy 21 . Intervention Daily oral supplementation with antioxidants ( selenium 10 μg , zinc 5 mg , vitamin A 0.9 mg , vitamin E 100 mg , and vitamin C 50 mg ) , folinic acid ( 0.1 mg ) , antioxidants and folinic acid combined , or placebo . Main outcome measures Griffiths developmental quotient and an adapted MacArthur communicative development inventory 18 months after starting supplementation ; biochemical markers in blood and urine at age 12 months . Results Children r and omised to antioxidant supplements attained similar developmental outcomes to those without antioxidants ( mean Griffiths developmental quotient 57.3 v 56.1 ; adjusted mean difference 1.2 points , 95 % confidence interval −2.2 to 4.6 ) . Comparison of children r and omised to folinic acid supplements or no folinic acid also showed no significant differences in Griffiths developmental quotient ( mean 57.6 v 55.9 ; adjusted mean difference 1.7 , −1.7 to 5.1 ) . No between group differences were seen in the mean numbers of words said or signed : for antioxidants versus none the ratio of means was 0.85 ( 95 % confidence interval 0.6 to 1.2 ) , and for folinic acid versus none it was 1.24 ( 0.87 to 1.77 ) . No significant differences were found between any of the groups in the biochemical outcomes measured . Adjustment for potential confounders did not appreciably change the results . Conclusions This study provides no evidence to support the use of antioxidant or folinic acid supplements in children with Down ’s syndrome . Trial registration Clinical trials NCT00378456",
"The effect of 250 μg folic acid (FA)/day or placebo given to 21 small-for-gestational-age infants born at term was studied during the first 3 months of life . The design of the study was double blind with r and om allocation . No r and omization was performed in respect of breast-feeding or formula-feeding with a folate content of 60–70 μg/l . No significant differences were observed in haemoglobin concentration , haematocrit , weight and length between FA-supplemented and non-supplemented infants . A negative correlation was demonstrated between gestational age and erythrocyte folate ( E-folate ) concentration at 1 week . E-folate content was higher when no supplement was given in breast-fed than in formula-fed infants",
"PURPOSE To assess the prevalence of hyperhomocysteinemia in pediatric patients treated with antiepileptic drugs ( AEDs ) and to evaluate the effect of folic acid supplementation on plasma total homocysteine ( tHcy ) concentrations in hyperhomocysteinemic patients . METHODS 123 patients from three regional hospitals participated in the study . Patients with hyperhomocysteinemia were included in a 3-month double-blind r and omized trial testing oral folic acid supplementation ( 1 mg/day ) versus placebo . RESULTS Hyperhomocysteinemia ( tHcy > 10.4 micromol/L ) was present in 19 of 123 patients . Patients with hyperhomocysteinemia were older ( 13.7 + /- 4 vs. 11.0 + /- 3.9 years ) and had significantly lower folate and cobalamin concentrations . Multidrug ( two or more ) AED treatment and duration of therapy correlated significantly with elevated total homocysteine ( tHcy ) and low folate . In contrast , polymorphisms in the methylene tetrahydrofolate reductase gene ( MTHFR 677 C-->T , 1298 A-->C , 1793 G-->A ) had no significant impact on tHcy . Nine of 19 patients with hyperhomocysteinemia were r and omized to placebo , whereas the remaining 10 patients received folic acid supplementation . Folic acid supplementation result ed in a significant increase of folate and decrease of tHcy , whereas both parameters remained unchanged in the placebo group . CONCLUSIONS Hyperhomocysteinemia is present in 15.5 % of children receiving long-term AED treatment . Multidrug treatment and long duration of therapy enhance the risk for hyperhomocysteinemia . Folic acid supplementation significantly reduces tHcy . We recommend assessment of serum folate and plasma tHcy in children receiving AEDs",
"OBJECTIVE To study the effect of multivitamin and folic acid supplementation on serum folate level and weight gain . MATERIAL AND METHOD A prospect i ve r and omized controlled study was conducted in malnourished children at the Nutrition Clinic , Queen Sirikit National Institute of Child Health from February to June 2000 . History taking , weight-height measurement , and blood testing for complete blood count ( CBC ) and serum folate level were done . Patients were r and omly by assigned into 2 groups . The study group was supplemented daily with multivitamins ( MVD ) along with a folic acid tablet while the control group was supplemented daily with MVD only , for 6 weeks . RESULTS Twenty-nine malnourished children were enrolled in the present study . They were r and omly by assigned into 2 groups , 14 children in the study group and 15 children in the control group . There were 11 boys ( 38 % ) and 18 girls ( 62 % ) . Mean age was 36.3 months . Anemia and low serum folate level were found in 24 per cent and 21 per cent respectively . There was no significant difference in the data of both groups , except that anemia was more common in the study group ( p = 0.018 ) . After 6 weeks of supplementation , increases in weight and serum folate level were significantly higher in the study group , but there was no significant difference in weight increased between both groups . CONCLUSION Folate deficiency may be found in malnourished children . Efficacy of folic acid supplement is good . Folic acid needs to be supplemented in malnourished children",
"Haematological indices and red cell folate levels ( RCF ) were measured during two annual surveys in a group of Gambian children aged 3 months-5 years who were participating in a trial of malaria chemoprophylaxis with Maloprim or chlorproguanil given with or without folate supplements . Chlorproguanil was given in an adult dose of 20 mg , Maloprim as one quarter or one half of the adult dose of 25 mg pyrimethamine and 100 mg dapsone . Antimalarials and folate supplements were given fortnightly . About 20 % of children had low RCF levels ( less than 100 ng/ml ) . Among children who did not receive supplementation with folate there were no significant differences in mean RCF levels between children who received Maloprim , chlorproguanil or placebo . Among children who received folate supplements , the mean RCF was significantly lower among those receiving chlorproguanil than among the controls . Mean RCF values were similar in children who received Maloprim or placebo . If chlorproguanil is used for malaria chemoprophylaxis in young children an age-related dose should be used",
"BACKGROUND . Endothelial dysfunction , a precursor of vascular disease , begins early in type 1 diabetes mellitus and is associated with folate status . METHODS . A r and omized , double-blind , placebo-controlled study of folate ( 5 mg daily ) and vitamin B6 ( 100 mg daily ) in 124 children with type 1 diabetes determined the immediate and 8-week effects of these vitamins , alone and in combination , on endothelial function . Endothelial function , assessed as flow-mediated dilation and glyceryltrinitrate-induced dilation with high-resolution ultrasound of the brachial artery , was measured at baseline , at 2 and 4 hours after the first dose ( n = 35 ) , and at 4 and 8 weeks of treatment ( n = 122 ) . RESULTS . Flow-mediated dilation normalized in all treatment groups . From baseline to 8 weeks , flow-mediated dilation improved with folate from 2.6 % ± 4.3 % ( mean ± SD ) to 9.7 % ± 6.0 % , with vitamin B6 from 3.5 % ± 4.0 % to 8.3 % ± 4.2 % , and with folate/vitamin B6 from 2.8 % ± 3.5 % to 10.5 % ± 4.4 % . This improvement in flow-mediated dilation occurred within 2 hours and was maintained at 8 weeks for each treatment . Flow-mediated dilation in the placebo group , and glyceryltrinitrate-induced dilation in all groups , did not change . Increases in serum folate , red cell folate , and serum vitamin B6 levels related to increases in flow-mediated dilation . Improvement in flow-mediated dilation was independent of changes in total plasma homocyst(e)ine , glucose , hemoglobin A1c , and high-sensitivity C-reactive protein levels . Baseline red cell folate levels and baseline diastolic blood pressure were related inversely to improvement in flow-mediated dilation . Serum triglyceride and low-density lipoprotein cholesterol inversely related to baseline flow-mediated dilation . CONCLUSIONS . High-dose folate and vitamin B6 normalized endothelial dysfunction in children with type 1 diabetes . This effect was maintained over 8 weeks , with no additional benefit from combination treatment",
"The birthweights of 100 infants with erythroblastosis were carefully matched as to sex , gestational age , and parity with the birthweights of 200 control infants born during the same period . At all gestational ages the average birthweight of the affected infants was below that of the controls , the average reduction being 227 g. The more severely affected infants tended to be at a lower centile for birthweight than were the mildly affected ones . The relationships between maternal serum folate , cord blood serum folate , and centile for birthweight among affected infants were also studied . There was a strong correlation between low maternal serum folate and the incidence of small-for- date s babies among the affected infants . There was also a strong correlation between maternal and cord blood serum folate values . There was a lack of correlation between maternal serum folate and cord blood haemoglobin . It is concluded that infants with erythroblastosis are lighter than controls and that the reason for this may be a shortage of folic acid available for fetal growth",
"The effect of suboptimal folate nutrtion on the growing infant was studied in a population of infants fed a diet based on boiled , pasteurised cows ' milk . One group of infants received a daily supplement of 1 mg folic acid from age 2 months , while the other group received a placebo . The infants were seen at bimonthly intervals . In the supplemented group the red cell folate level had increased to twice its pretreatment value by 4 months , and remained at this high level to the end of the first year . Hb concentration and incidence of anaemia were similar in both groups . The incidence of infection in the two groups did not differ . Weights and lengths attained at 6 months , and the rate of gain from 2 to 6 months were higher in infants whose folate levels were above the median value than in those below it . In the second half of the first year the differences between the two groups were no longer evident",
"Objective : The incidence of cerebrovascular accidents ( CVA ) occurring perinatally is relatively high and aspects of the multifactorial pathophysiology remain unclear . Elevated homocysteine concentrations have been shown to be associated with an increased risk for CVA in children and even in newborns . We studied the possible homocysteine lowering effect of folinic acid in newborns . Method : We included 37 newborns in our prospect i ve r and omized folinic acid ( given as 5-formyltetrahydrofolate ) intervention study from patients admitted to our neonatal intensive care unit ( 18 controls , 19 intervention group ) . We measured total homocysteine ( tHcy ) and plasma folate concentrations at three time points ( baseline , 1 and 2 weeks after intervention ) . The intervention group was treated with folinic acid ( 70 μg/kg/day ) for 2 weeks . We calculated median concentrations ( 25th and 75th percentiles ) . Results : Median tHcy concentrations at the three time points did not differ from each other in the control group nor in the intervention group . We also could not observe different tHcy concentrations between both groups . Plasma folate concentrations increased in the intervention group ( mean increase 167 % ( 95 % confidence interval ( CI ) −291 , 625 ) ) compared with control group ( mean increase −12 % ( 95 % CI −132 , 108 ) ) , P for treatment effect : 0.03 . Conclusion : We could not demonstrate a homocysteine lowering effect of folinic acid administration in newborns . This indicates that one carbon metabolism in newborns differs form adults . Cobalamin might be a better strategy to lower tHcy concentrations in newborns",
"The effect of folic acid supplement ( 15 mg folic acid per day ) for 5 weeks was studied on a group of 5 children aged 8 - 12 years who were admitted to hospital . The result was compared to a control group of 5 children who were given a placebo . After supplementation , both serum and red cell folate levels in the experimental group significantly increased , i.e. , 15 fold ( 82.0 ng/ml ) and 4 fold ( 880 ng/ml ) , respectively . Serum UFBP decreased considerably while TFBP showed no significant alteration which result ed in the elevation of the % saturation to its maximum value . These findings indicated that the supplementary folic acid not only increased both serum and red cell folate levels and saturated nearly all serum UFBP but also elevated the % saturation markedly . There were no definite changes of serum vitamin B12 , UBBC , TBBC and TC levels of the experimental group from those of the control group . There were slightly but not significantly increased blood haemoglobin and haematocrit levels in both groups of children . This indicated that folic acid supplement had no definite effect on vitamin B12 and haematological findings in this study",
"A double‐blind , cross‐over test of folic acid and placebo was carried out in children who had a folate deficiency due to prolonged treatment with phenytoin . Despite large and long‐ lasting increases in blood folate levels , no associated changes were found in the frequency of fits , EEG , behaviour or gingival conditions . The trial therefore failed to reveal a relationship between the anti‐folate effects of phenytoin and its anticonvulsant action",
"The objective of this study was to assess the prevalence of anemia and the therapeutic and prophylactic response to ferrous sulfate and folic acid . A double-blind , r and omized , controlled clinical trial was conducted with 196 children 6 to 24 months of age enrolled in municipal daycare centers in Goiânia , Goiás State , Brazil . The children were assigned to two treatment groups that received a daily dose ( 5 times a week ) of either 4.2mg/kg/day of ferrous sulfate + folic acid ( 50microg ) or 4.2mg/kg/day of ferrous sulfate + folic acid placebo . One of the prevention groups received 1.4mg/kg/day of ferrous sulfate + folic acid ( 50microg/day ) and the other 1.4mg/kg/day of ferrous sulfate + folic acid placebo . Supplementation lasted approximately three months . Baseline anemia prevalence was 56.1 % ( 95%CI : 48.9 - 63.1 ) . After treatment , anemia prevalence in the folic acid group ( 14 % ) was lower than in the placebo group ( 34.9 % ) ( p = 0.02 ) . After prophylaxis in the non-anemic children , the incidence of anemia did not differ between the groups , but there was an increase in hemoglobin level in the folic acid group ( p = 0.003 ) . Iron plus folic acid was effective for the treatment of anemia and improvement of hemoglobin level in non-anemic children",
"A double-blind r and omized trial of 50 μg folic acid or placebo given from 2 weeks to 6 months to 130 infants of birthweight less than 2·5 kg has been conducted . While only 62 of the babies completed the 6-month follow-up , no significant difference was found between either group in respect of changes in weight , haemoglobin , serum folate , red cell folate , or evidence of infection . It is concluded that infants in this series were receiving adequate amounts of folic acid in their normal diet and did not require supplements"
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BACKGROUND Appendicitis is the most common cause of acute abdominal pain requiring surgical intervention . The cause of appendicitis is unclear and the mechanism of pathogenesis continues to be debated . Despite improved asepsis and surgical techniques , postoperative complications , such as wound infection and intraabdominal abscess , still account for a significant morbidity . Several studies implicate that postoperative infections are reduced by administration of antimicrobial regimes . OBJECTIVES This review evaluated the use of antibiotics compared to placebo or no treatment in patients undergoing appendectomy . Will these patients benefit from antimicrobial prophylaxis ? The outcomes were described according to the nature of the appendix , as either simple appendicitis ( including the non-infectious stage ) and complicated appendicitis . The efficacy of different antibiotic regimens were not evaluated . SEARCH STRATEGY We search ed The Cochrane Central Register of Controlled Trials ( Cochrane Library 2005 issue 1 ) ; Pubmed ; EMBASE ; and the Cochrane Colorectal Cancer Group Specialised Register ( April 2005 ) . In addition , we manually search ed the reference lists of the primary identified trials . SELECTION CRITERIA We evaluated R and omised Controlled Trials ( RCTs ) and Controlled Clinical Trials ( CCTs ) in which any antibiotic regime were compared to placebo in patients suspected of having appendicitis , and undergoing appendectomy . Both studies on children and adults were review ed . The outcome measures of the studies were : Wound infection , intra abdominal abscess , length of stay in hospital , and mortality . DATA COLLECTION AND ANALYSIS Eligibility and trial quality were assessed , recorded and cross-checked by two review ers . MAIN RESULTS Forty-five studies including 9576 patients were included in this review . The overall result is that the use of antibiotics is superior to placebo for preventing wound infection and intraabdominal abscess , with no apparent difference in the nature of the removed appendix . Studies exclusively on children and studies examining topical application reported results in favour to the above , although the results were not significant . AUTHORS ' CONCLUSIONS Antibiotic prophylaxis is effective in the prevention of postoperative complications in appendectomised patients , whether the administration is given pre- , peri- or post-operatively , and could be considered for routine in emergency appendectomies | [
"544 children operated upon for uncomplicated appendicitis were r and omised into three groups . Group I received no antibiotics , patients in Group II were administered one single pre-operative dose of metronidazole ( 10 mg/kg ) and patients in Group III received both both metronidazole ( 20 mg/kg ) and cefuroxime ( 50 mg/kg ) in a single preoperative dose . The rate of infectious complications in Group I was 6.3 % but only 2.1 and 2.3 in Groups II and III , respectively . Among patients with a normal appendix or patients with simple appendicitis there was no difference in the rate of post-operative infections between the three different groups . However , in patients with gangrenous appendicitis the rate of postoperative infections was significantly lower in the two groups who received preoperative antibiotics ( 1.8 % and 3.0 % respectively ) than in the group receiving no prophylactic antibiotics ( infection rate 14 % ) . It is concluded that a single preoperative dose of metronidazole significantly decreases the rate of postoperative infectious complications in children with appendicitis . No further improvement could be demonstrated if cefuroxime against aerobic organisms was added",
"The conventional treatment of acute appendicitis is appendectomy followed by intravenous ( IV ) antibiotics until intraabdominal infection has resolved . It is controversial as to whether it is efficacious to add a course of oral antibiotics after cessation of IV antibiotics . All consenting patients who presented to Kern Medical Center between October 2000 and June 2003 with acute appendicitis were entered into the study . Perforated/gangrenous appendicitis was equally represented in the two study arms . After appendectomy , and when IV antibiotics were ready to be discontinued , patients were r and omized to receive a 7-day outpatient course of either placebo ( Group 1 ) or oral antibiotics ( Group 2 ) . Patients were monitored for infectious complications for a minimum of 3 months , and there was no statistical difference ( 11.5 % in Group 1 vs 12.1 % in Group 2 , P = 0.61 ) . The data suggest that adding a course of outpatient oral antibiotics , after completing a course of IV antibiotics , does not decrease postoperative infectious complications in appendicitis patients",
" A series of 102 consecutive patients undergoing appendectomy through an incision in the right iliac fossa entered a prospect i ve r and omized trial to compare the effects of a 2 gram intravenous bolus dose of cefam and ole with a control study . No differences occurred in the incidence of wound infection in the two groups . We conclude that there is no place for a single preoperative dosage of cefam and ole in the management of appendicitis",
"A r and omized controlled trail in 374 patients requiring emergency appendicectomy to determine the value of topical ampicillin and antiseptic solution of chlorhexidine and cetyl trimethyl ammonium bromide ( Savlon ) in preventing wound infection is reported . The application of 1 g of ampicillin powder to the wound significantly reduced wound infection in perforated appendicitis , but not in unperforated appendicitis . Wound irrigation with 1 per cent cetyl trimethyl ammonium bromide was ineffective in preventing wound infection in all grade s of appendicitis . When wound contamination is difficult to avoid , as in perforated appendicitis , topical ampicillin should be used to reduce the rate of wound infection",
" This study sought to determine in a district general hospital ( a ) the frequency and nature of bacterial contamination at operation , ( b ) the incidence of consequent infection and ( c ) the prophylactic effect , if any , of inter‐parietal povidone‐iodine against postoperative wound infection",
" A total of 133 children , aged 16 months to 15 years ( mean 6.7 years ) , with presumptive acute appendicitis , was included in a double-blind , placebo-controlled trial of the short-term ( 72 hour ) use of metronidazole suppositories as prophylaxis against post-operative infection . There was no significant difference in the incidence or severity of wound infection or post-operative intra-abdominal sepsis between the metronidazole-treated and placebo groups . It is suggested that intra-rectal metronidazole , when used exclusively , is not sufficient for effective prophylaxis for appendicitis in childhood",
"A total of 223 consecutive suspected appendicitis patients were treated preoperatively with parenteral tinidazole or physiological saline ( control group ) . An infusion of 500 mg tinidazole was given to 110 patients over 30 minutes beginning about 30 minutes before the start of the operation , the control group comprised 111 patients . Postoperative infections were diagnosed in three patients in the group receiving tinidazole ( 3 % ) and in 17 patients in the control group ( 15 % ) . The difference was statistically significant . There were no side-effects due to the drugs . Tinidazole appears to be well suited to the prophylaxis of post-appendicectomy infections",
"A controlled trial of intraperitoneal noxytiolin ( Noxiflex ) solution in patients with peritonitis due to perforafed appendicitis is reported . No significant difference was found in the incidence of complications between the treated and a control group , raising doubts as to whether this substance is of value when used intraperitoneally in peritonitis",
"The authors question the need to give prophylactic antibiotics perioperatively in all cases of acute appendicitis without perforation to reduce the rate of wound infection . A retrospective study of 82 patients showed a wound infection rate of 4.8 % ; 3 of 53 patients who did not receive antibiotics had a wound infection compared with 1 of 29 patients who received antibiotics . A prospect i ve double-blind clinical trial was performed comparing the results of perioperative administration of cefam and ole and placebo . One of 21 patients who received the placebo had a wound infection ; none of the 21 patients given cefam and ole had infection . Thus , the authors conclude that , although reports in the literature suggest that antibiotics given perioperatively decrease the rate of wound infection in acute appendicitis without perforation , the incidence of such infection is too low to warrant routine administration . They suggest that such antibiotic use be reserved for those suspected of having more serious disease",
"A prospect i ve r and omized clinical trial was performed to determine the efficiency of single-dose antibiotic prophylaxis in preventing septic complications after appendectomy . The infection rate increased significantly in the control group without antibiotic prophylaxis ( 9.3 % to 20.3 % ) . Older patients with severe appendicitis had more advantages from the prophylaxis than younger ones . We have suggested to perform antibiotic prophylaxis individually only in those patients with high risk of septic complications after appendectomy",
" Two hundred and fifty patients were admitted to a prospect i ve r and omized trial of single dosage prophylaxis against wound infection after appendicectomy . There were 12 exclusions , 72 patients received placebo , 81 received 600 mg i.m . clindamycin phosphate and 85 received 1 g i.m . cefazolin sodium , the agent being given in the anaesthetic room . Clindamycin produced a significant reduction in the overall rate of wound infection from 33 per cent in the controls to 17 per cent . In cases with a gangrenous or perforated appendix the infection rate in controls was 78 per cent ; this was reduced to 44 per cent by a single dose of clindamycin",
"Prospect i ve investigation of consecutive children suffering from non-perforating appendicitis indicated that metronidazole prophylaxis significantly reduces the risk of postoperative wound sepsis regardless of the method of closure . However , in view of the advantages of subcuticular polyglycolic acid this must be regarded as the method of closure of choice in non-perforating appendicitis in children",
"A prospect i ve , r and omized , double-blind study on the effect of cephaloridine prophylaxis in the surgical management of appendicitis was performed . Of the 139 patients studied , 70 received cephaloridine and 69 received placebo prophylaxis . Both groups of patients were well matched with regard to age , sex , operative findings , and bacteria isolated at operation . Postoperative wound infections were detected in 11.6 % of placebo-treated patients and in 1.4 % of cephaloridine-treated patients ( P less than .02 ) . Prophylactic treatment with cephaloridine of patients undergoing surgery for uncomplicated appendicitis result ed in a perceptible reduction in the rate of postoperative wound infection",
"Post-appendicectomy sepsis still causes considerable morbidity and prolongs hospital stay . A large amount of recent work has gone into attempts to reduce such problems using various topical and systemic agents in differing regimes , with wide variation in their results . The aim of our study was to examine further the effectiveness of those different lines of prophylaxis against placebo in reducing post-appendicectomy sepsis . It is a comparative study of 400 cases of uncomplicated appendicitis operated upon by three senior Surgeons . The cases were allocated r and omly in equal number to four groups according to the prophylactic antibiotic regime used : ( a ) Placebo ; ( b ) Metronidazole alone ; ( c ) Metronidazole and cefazolin ; ( d ) Metronidazole and tobramycin . Antibiotics were given preoperatively with premedication and continued postoperatively for three days . The patients were checked for signs of sepsis during hospital stay and weekly up to a minimum of four weeks after discharge . They were also compared as far as their hospital stay is concerned . The conclusion of this study is that a combination of an antibiotic aim ed at aerobes ( cefazolin or tobramycin ) with another aim ing at anaerobes ( metronidazole ) is the best prophylactic regime against post-appendicectomy sepsis",
"A prospect i ve , r and omized , clinical study was carried out in 188 patients undergoing appendicectomy or colorectal surgery to test the efficacy of prophylactic , parenterally-administered antibiotics in the prevention of infection . The results show the effectiveness of the association gentamicin-metronidazole ( 9.4 % of infections ) , compared to the control group with no antibiotics ( 39.1 % of infections ) , X2 = 14.1 ; P less than 0.001 )",
"In a r and omized controlled trial of the use of a single intravenous dose of gentamicin sulfate and clindamycin phosphate used intraoperatively during emergency abdominal surgery , the overall incidence of postoperative wound infection was reduced from 32.3 % to 10.4 % . Significant reduction in wound infection occurred in the study group compared with control subjects irrespective of the underlying pathologic lesion . No side effects of the use of antibiotics were noted . The policy of antibiotic prophylaxis in emergency surgery seems to be of particular benefit in elderly patients",
" In a series of 762 general surgical wounds 376 were selected at r and om to receive three parenteral doses of cephaloridine and 386 remained as untreated controls . In all types of operation , with the exception of wounds in the lower extremities associated with arterial surgery , the rate of wound infection was lowered by the prophylactic use of cephaloridine . The results were statistically significant for total wounds , clean wounds , total contaminated wounds , and contaminated wounds other than in colorectal surgery . We therefore recommend the routine use of three doses of cephaloridine",
"The efficacy of a single 500 mg intravenous intra-operative dose of metronidazole in the prevention of postoperative wound infection , following appendicectomy for acute mural appendicitis , was studied in a prospect i ve r and omized placebo controlled trial . Fourteen of the 96 patients ( 14.6 % ) in the metronidazole group and 13 of the 94 in the placebo group ( 13.8 % ) developed postoperative wound infection . Late sepsis was noted in 4 out of the 96 patients in the metronidazole group and in one of the 94 patients in the placebo group . This study suggests that a single intra-operative dose of metronidazole dose not reduce the incidence of postoperative wound infection following appendicectomy for acute mural appendicitis",
"In the search for an appropriate antibiotic to reduce the rate of postoperative wound infection in patients with acute appendicitis , we have r and omized 150 patients preoperatively in a prospect i ve 3-arm study . The operation technique was st and ardized for all patients and involved the use of plastic wound protectors . Bacterial contamination was documented by 3 swabs taken during operation . In 2 arms , patients received short-term adjuvant prophylaxis with either cefazolin or clindamycin/tobramycin . The third arm served as a control . Wound contamination ws proven in 33 % of all cases but only 4 % developed a real wound infection . The rate of infection was almost identical in all groups , without a statistically significant difference in the chi2 test . It is concluded that wound infection after appendectomy can not be prevented by prophylactic use of antibiotics . Careful operation technique with local protective steps is quite sufficient . Antibiotics should therefore be reserved for special indications",
"One hundred patients undergoing appendicectomy through a right iliac fossa incision were r and omized to receive normal saline or 500 mg metronidazole as an intravenous infusion during the operation . One patient in the saline group developed an erythcmatous rash . There were 13 wound infections ( as defined by the discharge of pus ) , 12 ( out of 51 ) in the saline group and 1 ( out of 49 ) in the metronidazole group . Bacteroides spp . were frequently cultured from the lumen of removed appendices and from pus obtained from infected wounds . This work supports the value of metronidazole but suggests that a single‐dose regimen is adequate for prophylaxis",
"A prospect i ve r and omized clinical trial was performed to determine the efficiency of single-dose antibiotic prophylaxis in preventing septic complications after appendectomy . The infection rate increased significantly in the control group without antibiotic prophylaxis ( 9.3 % to 20.3 % ) . Older patients with severe appendicitis had more advantages from the prophylaxis than younger one . We have suggested to perform antibiotic prophylaxis individually only in those patients with high risk of septic complications after appendectomy",
"This study investigated the use of antibiotics in the treatment of wound infections after appendectomy . The subjects were 72 patients with post-operative wound infections at a district general hospital in Jordan . All patients received daily antiseptic dressings with povidone-iodine 10 % in alcohol . The patients were r and omized in a single-blind trial to receive either no antibiotics or parenteral antibiotics metronidazole and cefoxitin . There was no significant effect of antibiotic use in patients with early inflamed or severely inflamed appendicitis . However , for patients with perforated appendicitis the mean length of hospital stay and the mean frequency of change of dressings were significantly reduced . We conclude that antibiotics do not offer any advantage in post-appendectomy wound infections except for cases of perforated appendix",
"Abstract In a prospect i ve , r and omized , nonblind clinical trial , single-dose intrarectal metronidazole prophylaxis reduced significantly (",
"A r and omized stratified clinical trial of topical povidone‐iodine in 627 patients undergoing abdominal procedures demonstrated a reduction in postoperative wound sepsis in female patients , in patients receiving subcutaneous low dose heparin and during the first quarter of the trial when the infection rate in control subjects was high . Overall , there was no significant reduction in wound sepsis after administration of povidone‐iodine due mainly to a high infection rate in povidone‐iodine treated male appendix operations where , by chance , there was an increased incidence of contamination with Bacteroides fragilis",
"Ninety-eight patients with suspected nonperforated acute appendicitis have to date been entered into a continuing , prospect i ve , blinded r and omized trial to determine the role of prophylactic metronidazole in postoperative wound infection . Twenty-six patients were excluded for the following reasons : diagnosis other than acute appendicitis ( 16 ) , perforation of the appendix ( 8) , administration of other antibiotics ( 1 ) , and refusal to enter study ( 1 ) . Seventy-two patients , 47 men and 25 women , with a mean age of 27.5 years ( range 15 to 60 years ) , underwent appendectomy and were studied . Thirty patients received 1 gm intravenous metronidazole preoperatively and five intravenous doses of 500 mg metronidazole postoperatively . Forty-two patients received placebo only . Cultures of the appendiceal stump grew aerobic cultures in 45 ( 62 % ) and anaerobic organisms in 29 ( 40 % ) : Escherichia coli and Bacteroides fragilis , respectively . Six of the 72 patients ( 8.2 % ) developed postoperative wound infections : four of 42 ( 9.5 % ) who received placebo and two of 30 ( 6.6 % ) who received metronidazole ( P = 0.54 by Fisher exact test ) . No toxicity from metronidazole was observed . The postoperative wound infection rate is insufficient to demonstrate the efficacy of metronidazole for prophylaxis in nonperforated acute appendicitis , although there appears to be a tendency of to assume its efficacy in this regard",
"A prospect i ve , r and omized , clinical study was done to evaluate the place of prophylactic antibiotics in uncomplicated childhood appendicitis . One hundred patients with uncomplicated appendicitis were r and omly assigned to one of four groups , each consisting of 25 cases . Group 1 patients did not receive prophylactic antibiotic . Group 2 , group 3 , and group 4 patients received ornidazole , penicillin plus tobramycin , and piperacillin , respectively . The use of prophylactic antibiotics did not yield better results than the use of placebos . The rarity of infectious complications after uncomplicated appendicectomy may be unique for children . Although the need for antibiotic prophylaxis is well documented in adults , the rarity of infectious complications makes it highly question able in the treatment of uncomplicated appendicitis in children",
"The role of prophylactic antibiotics is well established for contaminated wounds , but the use of antiseptic wound wicks is controversial . The aim of this work was to study the potential use of wound wicks to reduce the rate of infection following appendectomy . This prospect i ve r and omized controlled clinical trial was conducted at a university hospital in the department of surgery . The subjects were patients undergoing appendectomy for definite acute appendicitis . They were r and omized by computer to primary subcuticular wound closure or use of an antiseptic wound wick . For the latter , ribbon gauze soaked in povidone-iodine was placed between interrupted nylon skin sutures . Wicks were soaked daily and removed on the fourth postoperative day . All patients received antibiotic prophylaxis . They were review ed while in hospital and 4 weeks following operation for evidence of wound infection . The main outcome measures were wound infection , wound discomfort , and cosmetic result . The overall wound infection rate was 8.6 % ( 15/174 ) . In patients with wound wicks it was 11.6 % ( 10/86 ) compared to 5.6 % ( 5/88 ) in those whose wounds were closed by subcuticular sutures ( p = NS ) . We concluded that the use of wound wicks was not associated with decreased wound infection rates following appendectomy . Subcuticular closure is therefore appropriate in view of its greater convenience and safety . RésuméDans les plaies contaminées , le rôle de l’antibioprophylaxie est bien établi mais l’utilisation des pansements antiseptiques reste controversé . Le but de cette étude a été d’évaluer le potentiel d’utilisation de mèches antiseptiques dans la réduction du taux d’infection après appendicectomie . Cette étude , contrôlée par r and omisation , provenant d’un service de chirurgie universitaire , comprend des patients opérés d’appendicectomie pour appendicite aiguë . Les patients ont été r and omisés selon une méthode informatique pour recevoir soit une fermeture sous-cutanée primitive soit l’utilisation d’un pansement antiseptique . Dans ce dernier cas , la plaie a été traitée par un ruban de gaze trempé dans une solution de polividone iodé placé entre des sutures cutanées à points séparés . Les mèches ont été imbibées tous les jours et enlevées au quatrième jour . Tous les patients ont eu une antibioprophylaxie . Tous les patients ont été revus à l’hôpital et quatre semaines après leur sortie . Les critères de jugement ont été : l’infection de la plaie , une gène au niveau de la plaie et l’aspect esthétique . Le taux d’infection global a été de 8.6 % ( 15/174 ) . Chez les patients avec des pansements , ce taux a été de 11.6 % ( 10/86 ) comparé à 5.6 % ( 5/88 ) chez les patients do nt la plaie a été fermée par sutures sous-cutanées ( p = NS ) . L’utilisation de mèches ne diminue pas le taux d’infection de la plaie après apfrendfcectomie . La fermeture sous-cutanée est donc appropriée en vue de son applicabilité et sécurité . ResumenEn heridas contaminadas el papel de la antibioticoprofilaxis está bien definido , pero la introducción dentro de la herida de tiras antisépticas sigue est and o controvertida . El objetivo de este estudio fue valorar la posible utilidad de la colocación de tiras asépticas en la reducción de las infecciones de las heridas operatorias tras apendicectomía . En un departamento quirúrgico de un Hospital Universitario se realizó este estudio prospect ivo r and omizado y controlado . En él se incluyeron todos aquellos pacientes apendicectomizados por padecer una apendicitis aguda verdadera . Los pacientes se r and omizaron mediante ordenador para que en unos , se suturase primariamente el tejido celular subcutáneo y en otro , se empleasen tiras antisépticas . Las tiras de gasa empapadas en povidona yodada se introdujeron entre los puntos entrecortados de piel . Las tiras se empapaban diariamente con povidona yodada y se retiraron al 4 ° día del postoperatorio . Todos los pacientes recibieron antibioticoprofilaxis . Fueron curados y revisados durante su estancia hospitalaria y a las 4 semanas de la operación con objeto de valorar la existencia o no de infección de la herida operatoria . Se evaluaron : la infección de la herida , molestias a su nivel y result ados cosméticos . La incidencia global de infección de la herida operatoria fue del 8.6 % ( 15/174 ) . En pacientes tratados con tiras asépticas alcanzó el 11.6 % ( 10/86 ) mientras que las heridas en las que se suturó el tejido celular subcutáneo el porcentaje de infección fue del 5.6 % ( 15/88 ) p = NS . Tras apendicectomía , la infección de la herida operatoria no disminuyó con un tratamiento de tiras asépticas . La sutura del tejido celular subcutáneo parece ser más conveniente y segura",
"A prospect i ve , r and omized , double-blind clinical study was performed to determine the efficacy of perioperative systemic antibiotics in preventing infection after appendectomy for acute nonperforating appendicitis . One hundred three patients received three doses of either placebo ( saline , n = 52 ) or cefoxitin sodium ( n = 51 ) . The two groups were similar with regard to age distribution , sex ratio , duration of operation , pathologic condition of appendix , and hospital stay . Postoperative wound infections were detected in 9.6 % of the placebo-treated patients , whereas none occurred in the cefoxitin group . All but one infection appeared after discharge . Cost analysis identified a net savings of $ 84 per patient with the use of prophylactic antibiotics . Septic morbidity after appendectomy for nonperforating appendicitis is significantly reduced by systemic antibiotics , and brief administration of a single broad-spectrum agent ( cefoxitin ) is effective prophylaxis",
"A prospect i ve , r and omized , double-blind clinical study was performed to determine the efficacy of short-term ( 24 hr ) perioperative antibiotics in preventing septic complications after emergency appendectomy for nonperforated appendicitis . The patients were stratified into three clinical arms : Group I ( placebo , n = 45 ) , Group II ( cefam and ole , n = 46 ) and Group III ( cefam and ole plus carbenicillin , n = 45 ) . The three groups of patients were similar in regard to age , sex , duration of operation and pathologic classification of the appendix . The overall incidence of infection in the study was 5.1 % . The infection rates in Groups II ( 2.2 % ) and III ( 0 % ) were significantly lower than Group I ( placebo ) ( 13.3 % ) , ( p ≤ 0.05 ) . No difference was observed between cefam and ole alone and cefam and ole plus carbenicillin . Average postoperative hospital days per patient for each group was : Group IAC3.8 days ; Group IIAC2.9 days ; Group IIIAC3.1 days . Cost analysis of hospitalization including cost of prophylactic antibiotics revealed a $ 247.99 per patient saving for Group II versus Group I and $ 95.53 for Group III versus Group I. Systemic prophylactic antibiotics can successfully reduce septic complications after appendectomy for non-perforated appendicitis , and a single drug ( cefam and ole ) directed at the facultative pathogens is as effective as double drug therapy , which includes specific anaerobic",
"In a prospect i ve , block-r and omized , multicenter study , the safety and efficacy of cefoxitin in preoperative prophylaxis were studied . 1735 patients undergoing appendectomy were evaluable , and half of these patients received 2 g of cefoxitin before undergoing operation . The patients were divided into three groups : patients with a normal appendix , patients with an acutely inflamed appendix , and patients with a gangrenous appendix . The study showed for each group a significant reduction of the incidence of wound infection in patients receiving prophylaxis . However , intra-abdominal abscess formation was not influenced by preoperative antibiotic prophylaxis . Consequently , routine preoperative prophylaxis is recommended before appendectomy",
"A comparison of single-agent antimicrobial therapy in the treatment of patients with perforated or gangrenous appendicitis and peritonitis was performed in a double-blind , r and omized , prospect i ve trial . Pathologic documentation of advanced appendicitis and positive intraoperative specimen cultures were required for inclusion in the study . Ceftizoxime ( 2 gm every 12 hours ) and cefoxitin ( 2 gm every six hours ) were compared . There were no significant differences between the treatment groups . Ninety-seven percent of patients treated with ceftizoxime and 89 % of those treated with cefoxitin were cured or improved ; there was no mortality in either group . By the use of optimal sampling , transport , and culture techniques , the number and diversity of bacteria recovered from these patients with advanced appendicitis were found to be much larger than previously suspected . Peritoneal fluid , abscess contents ( if present ) , and appendiceal tissue ( obtained so as to exclude the lumen ) were cultured from all patients . An average number of 3.1 aerobic or facultative bacteria species and 8.5 anaerobic species were isolated from each specimen . Twenty-eight different genera and more than 55 species were encountered , including a previously undescribed fastidious gram-negative anaerobic bacillus . Bacteroides fragilis group and Escherichia coli were isolated from almost all specimens , and within the B fragilis group , eight species were represented . The recovery of such an unexpectedly large and diverse flora may be the reason for the therapeutic failures in these patients . We conclude that single-agent antimicrobial therapy in patients with advanced appendicitis and peritonitis is both safe and effective , and , with ceftizoxime , can be accomplished by a twice-daily dosing regimen",
"The 588 consecutive patients who were operated on on suspicion of appendicitis were r and omized into three groups : the control group ( no prophylaxis ) ; the single-dose group ( preoperatively 500 mg of tinidazole intravenously ) ; and the 3-day group ( in addition to the former , a 3-day tinidazole treatment ) . To discover any postoperative infectious complications , the patients ' follow-up study was extended for at least 1 month . Such complications emerged in 12 % of the patients in the control group , in 7 % of those in the single-dose group , and in 5 % of those in the 3-day group . A statistically significant difference in the incidence of infectious complications was established between the control group and the prophylaxis groups . The 3-day tinidazole treatment , as compared with the single-dose prophylaxis , did not further improve the outcome . On the basis of these results the authors recommend that all patients subjected to an appendicectomy be given an intravenous tinidazole prophylaxis",
"A r and omized double-blind trial was carried out in 405 patients undergoing appendicectomy to assess the prophylactic effect of metronidazole in postoperative infection . 200 patients received metronidazole and 206 received placebo . Preoperatively all patients were given an intravenous infusion of metronidazole or placebo . In patients with a perforated appendix postoperative medication was continued with suppositories containing either metronidazole or a placebo plus additional chemotherapy with penicillin and streptomycin . The infection rate in patients with a non-perforated appendix was 8 % in the placebo group and 1 % among those receiving metronidazole . In patients with a perforated appendix , the corresponding figures were 45 % and 0 % . These differences are statistically significant . B. fragilis and E. coli were isolated from the majority of the postoperative infections;. most often in a mixed culture . Both intravenous and rectal administration of metronidazole gave adequate blood levels . No side effects were encountered",
"A prospect i ve r and omized trial comparing prophylaxis with a single dose of cefam and ole given intravenously and preincisionally with no antibiotics in patients who underwent elective and emergency operations upon the gastrointestinal tract has shown a significant reduction in the frequency of wound infections in patients receiving preincisional antibiotics over both control and intravenous groups . Fewer postoperative infections of the chest occurred in patients receiving antibiotics by either route , with hospital stay also being significantly reduced for patients who received prophylactic antibiotics before emergency operations . Preincisional cefam and ole is effective in reducing postoperative sepsis after operations upon the gastrointestinal tract",
"The proper duration of postoperative intravenous ( IV ) antibiotics in patients suffering complicated ( perforated or gangrenous ) appendicitis is debatable . Some advocate a set minimum number of IV antibiotic days whereas others discontinue IV antibiotics depending on the patient 's clinical course regardless of the length of therapy . Our objective was to determine whether there are differences in morbidity and re source utilization between the two treatment method ologies . Ninety-four patients with intraoperative findings of complicated appendicitis were included . In all patients IV antibiotics were discontinued on the basis of clinical factors . However , Group 1 patients were given a minimum 5-day IV antibiotic course whereas Group 2 patients had no minimum IV antibiotic requirement . Group 1 patients received more IV antibiotics than Group 2 patients did ( 5.9 vs 4.3 days ; P = 0.014 ) . Infectious complications were not statistically different between the two groups ( 13.0 % in Group 1 and 12.5 % in Group 2 ) . Average hospital stay was also not statistically different between the two groups . The data suggest that a protocol with no minimum IV antibiotic requirement in patients with complicated appendicitis does not increase morbidity . Furthermore , the protocol arm with no minimum IV antibiotic requirement led to less IV antibiotic use but did not significantly decrease hospital stay",
"A double blind , r and omized , controlled trial was carried out at two hospitals to try the effect of metronidazole , which is effective against most anaerobes , and cefazolin , which is effective against many aerobic organisms , singly and in combination , on the incidence of wound sepsis following appendicectomy . Patients were placed at r and om into one of four groups ; to receive metronidazole and placebo , cefazolin and placebo , metronidazole and cefazolin , or double placebo . Patients with generalized peritonitis were excluded for ethical reasons . Treatment was started before operation and continued eight-hourly for twenty-four hours . All patients in the trial were followed up at about two weeks after discharge from hospital and their wounds inspected . Two hundred and seventy-one patients were assessed . Sepsis rates at the two hospitals were similar . On the untreated controls , 30 % discharged pus from their wounds , and in the groups receiving one drug only , about 20 % . In those receiving both drugs the infection rate was 3 % , a highly significant difference from that in the other three groups",
"Acute appendicitis continues as a medical challenge with newer approaches failing to improve diagnostic accuracy . The role of antibiotics in acute nonperforative appendicitis ( NPA ) remains unclear . In 175 patients studied at two hospitals , preoperative guidelines were used to exclude perforative appendicitis . Nevertheless , 14 % of patients were found to have this condition . Surgeon 's reports significantly underestimated the diagnosis when compared with the pathologists ' reports . Antibiotic prophylaxis in 122 patients with NPA was studied prospect ively comparing ceftizoxime ( CTZ ) , cefam and ole ( CFM ) , and placebo ( PLA ) . Ceftizoxime decreased the infection rate compared with PLA ( 0 vs. 8 ; P less than .01 ) . Use of antibiotics ( CTZ or CFM ) result ed in decreased infections when compared with PLA ( 3 vs. 8 ; P less than .01 ) and fewer days of hospitalization ( 3.8 vs. 5.4 d , P less than .005 ) . Analysis of infection risk factors showed no correlations except for failure to administer antibiotics and the finding of a gangrenous appendix . Operative culture results had no predictive value for either infection or pathogen identification . It is recommended that all patients undergoing surgery for NPA be given 1 d of antibiotic prophylaxis",
"In a prospect i ve r and omized double blind study , prophylactic cefam and ol therapy was compared to placebos before appendectomy . 25 of 220 patients had to be excluded . The overall infection rate was reduced from 13,1 % ( 1977/78 ) to 7,6 % ( 1979/80 ) . The infection rate differed in both groups ( antibiotic and placebo ) only for perforated appendices significantly . If there was a wound infection , the hospital stay of the treatment group was significantly reduced to the placebo group ( p less than 0,0005 ) . Predisposing factors for wound infection are leucocytosis greater than 12 000 , anamnesis greater than 24 hours , operation time greater than 45 minutes",
"The effect of a preoperative single intravenous dose of metronidazole was studied in a prospect i ve trial of 203 patients . 17.5 % of the patients in the control group developed a wound infection compared with 3.4 % of those receiving metronidazole ( p less than 0.001 ) . The average length of hospitalization and convalescence was significantly reduced in the metronidazole group . The use of metronidazole in prevention of wound infection is recommended",
"When given in conventional daily dosage , rifampicin is highly effective but very expensive , costing well over £ 200 a year for one patient . This makes the use of daily rifampicin regimens unrealistic in nearly all the developing countries and indeed in many technically advanced countries too . If an intermittent regimen containing a smaller total weekly dosage of rifampicin which is both therapeutically effective and of low toxicity could be found the applicability of this very valuable drug would be much increased . It would indeed be a great pity if the report of Dr. Poole and others were to be interpreted as discouraging further investigation along these lines . In the final analysis the aim must be to evaluate rifampicin-containing regimens in terms of efficacy , safety , convenience , cost and applicability , in comparison with the alternative regimens available for the treatment of the same type of disease , in the same population .-We are , etc .",
"Abstract The efficacy of intraoperative cephalothin irrigation of the peritoneal cavity was evaluated in ninety-four operative procedures on ninety-two patients . The study was prospect i ve and double blind and the patients were selected for the cephalothin or control group on a r and om basis . Evaluation of the two groups in regard to wound infections , failure to control intraperitoneal sepsis as indicated by intra-abdominal abscess or continuing peritonitis , and total number of deaths failed to reveal any significant difference between the two groups . Thus , copious cephalothin irrigation appears to be no better or worse than copious saline irrigation in the patient with peritonitis",
"A single intravenous dose of tobramycin and lincomycin , given at the start of gastrointestinal operations , significantly reduced the incidence of postoperative wound infection from 34 % to 5 % . The occurrence of both anaerobic and aerobic bacteria was reduced . Therapeutic concentrations of the antibiotics were maintained throughout the operative period in most cases . No toxic effects of the antibiotics were detected , no anaesthetic complication occurred , and resistant strains of bacteria normally sensitive to the antibiotics were not isolated from wounds",
"The effects of intrarectal metronidazole and intraincisional povidone iodine on sepsis after emergency appendicectomy were compared in a double-blind r and omised controlled trial in 496 patients . Wound sepsis occurred in 12.3 % of metronidazole-treated patients compared with 24 % in the povidone-iodine group and 23.5 % in an untreated control group . The metronidazole-treated patients left hospital approximately 2 days earlier than patients in the other two groups . They returned to work sooner and receiver fewer visits from the district nursing service . A short six-dose course of metronidazole significantly reduces the wound-infection rate in patients over the age of 12 undergoing emergency appendicectomy . If the clinical and economic benefits of metronidazole shown by this study are confirmed , the drug should be considered for routine use in emergency appendicectomy",
" 131 patients from 158 appendicectomies were r and omly divided before the operation into two groups : a single intravenous dose of metronidazole , and a physiological saline placebo group . The overall infection rate was 8.4 % . In the non-perforated cases the infection rates were 3.4 % in the metronidazole and 7.9 % in the placebo group . In cases with perforated appendix the infection rate was 40 % . There was no statistically significant difference in the infection rates between the groups . Our results give no clear indication of the benefit of metronidazole prophylaxis and we propose , therefore , to concentrate on the technical aspects of appendicectomy in infection prophylaxis",
"In a series of 349 operations a single dose of 500 mg . of ampicillin was given immediately preoperatively to 164 patients selected at r and om . There was no significant reduction in the wound‐infection rate in cases given ampicillin compared with the controls",
" Abstract From March 1 , 1966 through March 31 , 1967 , 525 patients on the General Surgery Service of Brooke General Hospital underwent abdominal surgery during which the gastrointestinal or the biliary tracts were open . In three ( 1.5 per cent ) of 189 patients who received prophylactically a combination of penicillin G , chloramphenicol , and methicillin before , during , and immediately after operation wound infections developed , whereas wound infections occurred in thirty-seven of 336 control patients . The difference in incidence of infection between these two groups of patients is highly significant ( p Specific groups of patients in whom the incidence of wound infections apparently was reduced significantly by prophylactic administration of antibiotics included those who underwent cholecystectomy , emergency gastric surgery for bleeding , elective gastric surgery , and emergency colostomies . In view of the high degree of statistical significance in the difference in incidence of wound infection in the totals of treated and control patients , the lack of statistically significant difference in incidence of wound infections between treated and control subgroups of patients undergoing other abdominal operations probably can be attributed to the small number of patients in these groups",
"OBJECTIVE To assess whether antibiotic treatment with cefuroxime and tinidazole started during the operation was as effective as treatment started before operation in patients with gangrenous non-perforated appendicitis . DESIGN Prospect i ve r and omised study . SETTING University hospital , Sweden . SUBJECTS 114 patients with gangrenous , non-perforated appendicitis who had had antibiotics started before operation and 120 whose treatment was started during operation out of a total of 575 who presented with a presumptive diagnosis of appendicitis . MAIN OUTCOME MEASURES Morbidity and mortality . RESULTS There were no deaths , and the rates of infective complications were 1/114 ( 0.9 % ) and 3/120 ( 3 % ) , respectively . The median hospital stay was four days in both groups . CONCLUSION Antibiotic treatment started during the operation is not significantly worse at preventing infective complications in non-perforated , gangrenous appendicitis than treatment started before the operation",
"The effect of topical ampicillin on the rate of wound infection after emergency appendicectomy was studied in a prospect i ve controlled trial of 200 patients . Sixteen per cent of patients in the control group developed a wound injection compared with 3 per cent of those receiving ampicillin powder in the wound ( P wound infection compared with 13 per cent of the 15 patients in the ampicillin group",
"A series of 102 patients with presumptive acute appendicitis entered a prospect i ve , r and omized , clinical trial of intrarectal metronidazole given over a 48‐h period commencing before surgery . Adequate levels of circulating metronidazole were achieved . A significant reduction in the incidence of anaerobic wound infection was observed in the treated group ( P allowed early discharge from hospital . No untoward effects were observed",
"A double-blind , r and omized controlled trial was carried out in University Hospital , Kuala Lumpur to study the effect of metronidazole and cotrimoxazole on the incidence of wound infection following appendicectomy from November 1978 to January 1980 . Patients were allocated at r and om into one of four groups : cotrimoxazole injection and placebo suppository , metronidazole suppository and cotrimoxazole injection , metronidazole suppository and placebo injection or placebo suppository and placebo injection . Treatment was started 30 min before operation and continued for 72h . All patients were followed up for 2 weeks and thereafter for one month . A total of 283 patients was finally accepted into the study . Sepsis rates were found to be 27 % for the untreated group , 9 % for the group receiving metronidazole only , 8 % for the group receiving cotrimoxazole injection only and 2.7 % for the group receiving both drugs . The study showed that a combination of metronidazole and cotrimoxazole is a regime highly effective for prophylaxis against wound infection following appendicectomy",
" Abstract All 253 appendicectomies done at a district general hospital over a five- month period were included in a controlled trial of wound spraying ( povidone iodine or polyantibiotic aerosols ) as a prophylactic measure against postoperative wound infection . A statistically significant reduction in the rate of infection was achieved . The routine use of a povidone iodine dry powder aerosol spray ( ' Disadine ' D.P. ) was justified because it reduced the incidence of wound infection in all degrees of appendicular inflammation without the risk of inducing the development of antibiotic-resistant bacterial strains",
"The frequency of non-clostridial anaerobic infection was studied in 95 patients who had undergone acute appendicectomy : 49 received prophylactic metronidazole and 46 received placebo . Anaerobic infection did not develop in any of the metronidazole-treated patients , but infections did develop in nine ( 19 % ) of the 46 controls . Metronidazole is conveniently administered by suppository to patients who can not take oral drugs . Five patients with intra-abdominal infections caused by non-clostridial anaerobes were successfully treated with metronidazole",
"The value of extraperitoneal wound drainage and a 3‐day course of prophylactic systemic cephaloridine used both separately and together have been assessed in a prospect i ve controlled r and omized trial involving 246 patients undergoing appendicectomy at the Leicester Royal Infirmary . Extraperitoneal wound drainage was shown to reduce significantly the incidence of post‐operative wound infection in patients with a gangrenous or perforated appendix ( P ) . Prophylactic cephaloridine significantly reduced the overall incidence of wound infection ( P significant reduction in wound infection was achieved when the appendix was gangrenous or perforated by the addition of wound drainage to the antibiotic regimen ( P<0·001 )",
"Prophylactic metronidazole was compared with no treatment in a r and omly allocated study of patients undergoing appendicectomy . A 1‐g suppository of metronidazole was given with the premedication and 200 mg t.d.s . orally for 7 days thereafter",
"The prophylactic use of a single dose of lincomycin in 100 patients undergoing appendicectomy reduced the incidence of postoperative wound injection from 17 to 6 per cent compared with a similar group of control patients . There was no correlation with the histological findings in the appendix , but patients with perforated appendicitis were excluded from the study . Bacteriological examination of the appendix area before surgery showed that Bacteroides fragilis and Escherichia coli were the organisms most frequently isolated . The majority of wound infections were due to B. fragilis , either alone or in association with aerobic organisms , but infection due to E. coli and Staphylococcus aureus also occurred",
"A prospect i ve placebo controlled r and omized trial was carried out in 104 patients with a presumptive diagnosis of acute appendicitis . A single dose of 1 g of metronidazole was given intra‐rectally 1 h preoperatively . There were 16 wound infections , 15 ( out of 50 ) in the placebo group , 1 ( out of 54 ) in the metronidazole group . This study supports the already accepted value of metronidazole but suggests that a single intra‐rectal dose regimen is adequate for prophylaxis",
"In the course of two consecutive , double-blind and prospect i ve studies , the authors evaluated the prophylactic effect of a single peroperative intravenous dose of gentamicin ( this study included 166 patients ) or the combination gentamicin and clindamycin ( this study included 127 patients ) , on the wound infection rate following interventions involving the incision of an abdominal hollow viscus . Antibiotic prophylaxis lowered the post-operative wound sepsis rate , especially following clinical ly contaminated interventions , but this reduction did not reach statistical significance . It is concluded that a single peroperative parenteral dose of antibiotics does not constitute an entirely satisfactory means of wound infection prophylaxis in digestive surgery",
"In an open prospect i ve r and omized study of appendicectomy , single-dose ( 1 g ) intravenous metronidazole prophylaxis ( and continued metronidazole plus nalidixic acid in perforated appendices ) result ed in a lower overall post-operative infection rate ( 1.4 % ) than no prophylaxis and doxycycline therapy in the case of perforation ( 16 % , p less than 0.025 ) . In patients with an unperforated appendix no infections occurred after single-dose metronidazole prophylaxis as opposed to 8.2 % infections in untreated controls ( p less than 0.025 )",
"A prospect i ve study was carried out to evaluate the effect of a strictly st and ardized , short-term prophylactic treatment with cephalothin ( Keflin ) on the incidence of postoperative wound infections in gastrointestinal surgery . Achieved levels of cephalothin activity in serum and interstitial water were studied , and the sensitivity of isolated bacteria at the end of operation and from septic wounds was defined . Patients were divided at r and om into treatment and control groups . The treatment group received 2 g cephalothin at the induction of anesthesia and another 2 g , 5 and 10 hours after the primary infusion . The control group remained untreated . The rapid infusion of 2 g cephalothin result ed in high initial serum levels , which declined rapidly . Equilibration between intra and extravascular compartments occurred about 60 - 80 minutes after start of infusion . At that time the infused dose result ed in a cephalothin level of about 30 mug/ml in ECV and plasma , or about 30 % of the initial concentration . Despite the prophylactic infusion of cephalothin , the frequency of wound infection in treated patients was the same as in the controls . Subdivision of the material according to type of surgery performed did not reveal any difference between untreated patients and controls . No shift towards cephalothin-resistant strains was observed in isolates from septic wounds in the treatment group"
] | 41162f18-06ff-11f0-808a-c43d1ab1c353 |
Although individual reports suggest that baseline morphometry or activity of transversus abdominis or lumbar multifidus predict clinical outcome of low back pain ( LBP ) , a related systematic review is unavailable . Therefore , this review summarized evidence regarding the predictive value of these muscular characteristics . C and i date publications were identified from 6 electronic medical data bases . After review , 5 cohort studies were included . Although this review intended to encompass studies using different muscle assessment methods , all included studies coincidentally used ultrasound imaging . No research investigated the relation between static morphometry and clinical outcomes . Evidence synthesis showed limited evidence supporting poor baseline transversus abdominis contraction thickness ratio as a treatment effect modifier favoring motor control exercise . Limited evidence supported that high baseline transversus abdominis lateral slide was associated with higher pain intensity after various exercise interventions at 1-year follow-up . However , there was limited evidence for the absence of relation between the contraction thickness ratio of transversus abdominis or anticipatory onset of lateral abdominal muscles at baseline and the short- or long-term LBP intensity after exercise interventions . There was conflicting evidence for a relation between baseline percent thickness change of lumbar multifidus during contraction and the clinical outcomes of patients after various conservative treatments . Given study heterogeneity , the small number of included studies and the inability of conventional greyscale B-mode ultrasound imaging to measure muscle activity , our findings should be interpreted with caution . Further large-scale prospect i ve studies that use appropriate technology ( ie , electromyography to assess muscle activity ) should be conducted to investigate the predictive value of morphometry or activity of these muscles with respect to LBP-related outcomes measures | [
"Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items",
"Study Design . A r and omized controlled trial . Objective . To investigate feed-forward activation or timing of abdominal muscle activation in response to rapid shoulder flexion after 8 weeks with core stability exercises , sling exercises , or general exercises in chronic nonspecific low back pain ( LBP ) patients . Summary of Background Data . Delayed onset in abdominal muscles has been associated with LBP . Low load exercises to volitionally activate the transversus abdominis were introduced to restore trunk muscle activation deficits . More forceful co-contraction exercises have been advocated by others . This study explored whether abdominal muscle onset changed after low-load core stability exercises , high-load sling exercises , or general exercises . Methods . Subjects ( N = 109 ) with chronic nonspecific LBP of at least 3 months ' duration were r and omly assigned to 8 weekly treatments with low-load core stability exercises , high-load stabilizing exercises in slings , or general exercises in groups . Primary outcome was onset recorded bilaterally by m-mode ultrasound imaging in the deep abdominal muscles in response to rapid shoulder flexion . Results . No or small changes were found in onset after treatment . Baseline adjusted between group differences showed a 15 ms ( 95 % confidence interval [ CI ] , 1–28 ; P = 0.03 ) and a 19 ms ( 95 % CI , 5–33 ; P with sling relative to core stability and general exercises , respectively , but on 1 side only . There was no association between changes in pain and onset over the intervention period ( R2 ⩽ 0.02 ) . Conclusion . Abdominal muscle onset was largely unaffected by 8 weeks of exercises in chronic LBP patients . There was no association between change in onset and LBP . Large individual variations in activation pattern of the deep abdominal muscles may justify exploration of differential effects in subgroups of LBP",
"OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review",
"Objectives Although motor control exercises have been shown to be effective in the management of low back pain ( LBP ) the mechanism of action is unclear . The current study investigated the relationship between the ability to recruit transversus abdominis and clinical outcomes of participants in a clinical trial . Methods Ultrasonography was used to assess the ability to recruit transversus abdominis in a nested design : a sample of 34 participants with chronic LBP was recruited from participants in a r and omised controlled trial comparing the efficacy of motor control exercise , general exercise and spinal manipulative therapy . Perceived recovery , function , disability and pain were also assessed . Results Participants with chronic LBP receiving motor control exercise had a greater improvement in recruitment of transversus abdominis ( 7.8 % ) than participants receiving general exercise ( 4.9 % reduction ) or spinal manipulative therapy ( 3.7 % reduction ) . The effect of motor control exercise on pain reduction was greater in participants who had a poor ability to recruit transversus abdominis at baseline . There was a significant , moderate correlation between improved recruitment of transversus abdominis and a reduction in disability ( r = −0.35 ; 95 % CI 0.02 to 0.62 ) . Conclusion These data provide some support for the hypothesised mechanism of action of motor control exercise and suggest that the treatment may be more effective in those with a poor ability to recruit transversus abdominis",
"Many studies have identified changes in trunk muscle recruitment in clinical low back pain ( LBP ) . However , due to the heterogeneity of the LBP population these changes have been variable and it has been impossible to identify a cause-effect relationship . Several studies have identified a consistent change in the feedforward postural response of transversus abdominis ( TrA ) , the deepest abdominal muscle , in association with arm movements in chronic LBP . This study aim ed to determine whether the feedforward recruitment of the trunk muscles in a postural task could be altered by acute experimentally induced LBP . Electromyographic ( EMG ) recordings of the abdominal and paraspinal muscles were made during arm movements in a control trial , following the injection of isotonic ( non-painful ) and hypertonic ( painful ) saline into the longissimus muscle at L4 , and during a 1-h follow-up . Movements included rapid arm flexion in response to a light and repetitive arm flexion-extension . Temporal and spatial EMG parameters were measured . The onset and amplitude of EMG of most muscles was changed in a variable manner during the period of experimentally induced pain . However , across movement trials and subjects the activation of TrA was consistently reduced in amplitude or delayed . Analyses in the time and frequency domain were used to confirm these findings . The results suggest that acute experimentally induced pain may affect feedforward postural activity of the trunk muscles . Although the response was variable , pain produced differential changes in the motor control of the trunk muscles , with consistent impairment of TrA activity",
"Study Design . A r and omized clinical trial with 1-year and 3-year telephone question naire follow-ups . Objective . To report a specific exercise intervention ’s long-term effects on recurrence rates in acute , first-episode low back pain patients . Summary of Background Data . The pain and disability associated with an initial episode of acute low back pain ( LBP ) is known to resolve spontaneously in the short-term in the majority of cases . However , the recurrence rate is high , and recurrent disabling episodes remain one of the most costly problems in LBP . A deficit in the multifidus muscle has been identified in acute LBP patients , and does not resolve spontaneously on resolution of painful symptoms and resumption of normal activity . Any relation between this deficit and recurrence rate was investigated in the long-term . Methods . Thirty-nine patients with acute , first-episode LBP were medically managed and r and omly allocated to either a control group or specific exercise group . Medical management included advice and use of medications . Intervention consisted of exercises aim ed at rehabilitating the multifidus in cocontraction with the transversus abdominis muscle . One year and three years after treatment , telephone question naires were conducted with patients . Results . Question naire results revealed that patients from the specific exercise group experienced fewer recurrences of LBP than patients from the control group . One year after treatment , specific exercise group recurrence was 30 % , and control group recurrence was 84 % ( P specific exercise group recurrence was 35 % , and control group recurrence was 75 % ( P specific exercise therapy in addition to medical management and resumption of normal activity may be more effective in reducing low back pain recurrences than medical management and normal activity alone",
"Study Design . Prospect i ve case series . Objective . To examine spinal stiffness in patients with low back pain ( LBP ) receiving spinal manipulative therapy ( SMT ) , evaluate associations between stiffness characteristics and clinical outcome , and explore a multivariate model of SMT mechanisms as related to effects on stiffness , lumbar multifidus ( LM ) recruitment , and status on a clinical prediction rule ( CPR ) for SMT outcomes . Summary of Background Data . Mechanisms underlying the clinical effects of SMT are poorly understood . Many explanations have been proposed , but few studies have related potential mechanisms to clinical outcomes or considered multiple mechanisms concurrently . Methods . Patients with LBP were treated with two SMT sessions over 1 week . CPR status was assessed at baseline . Clinical outcome was based on the Oswestry disability index ( ODI ) . Mechanized indentation measures of spinal stiffness and ultrasonic measures of LM recruitment were taken before and after each SMT , and after 1 week . Global and terminal stiffness were calculated . Multivariate regression was used to evaluate the relationship between stiffness variables and percentage ODI improvement . Zero-order correlations among stiffness variables , LM recruitment changes , CPR status , and clinical outcome were examined . A path analysis was used to evaluate a multivariate model of SMT effects . Results . Forty-eight patients ( 54 % women ) had complete stiffness data . Significant immediate decreases in global and terminal stiffness occurred post-SMT regardless of outcome . ODI improvement was related to greater immediate decrease in global stiffness ( P = 0.025 ) , and less initial terminal stiffness ( P = 0.01 ) . Zero-order correlations and path analysis supported a multivariate model suggesting that clinical outcome of SMT is mediated by improvements in LM recruitment and immediate decrease in global stiffness . Initial terminal stiffness and CPR status may relate to outcome though their relationship with LM recruitment . Conclusion . The underlying mechanisms explaining the benefits of SMT appear to be multifactorial . Both spinal stiffness characteristics and LM recruitment changes appear to play a role",
"OBJECTIVE To compare trunk muscle coordination in people with and without low back pain with varying speeds of limb movement . STUDY DESIGN Abdominal and back extensor muscle activity in association with upper limb movement was compared among three speeds of movement and between people with and without low back pain . PARTICIPANTS Fourteen subjects with a history of recurrent low back pain and a group of age- and sex-matched control subjects . MEASURES The onsets of electromyographic activity of the trunk and limb muscles , frequency of trunk muscle responses , and angular velocity of arm movements . RESULTS Early activation of transversus abdominis ( TrA ) and obliquus internus abdominis ( OI ) occurred in the majority of trials , with movement at both the fast and intermediate speeds for the control group . In contrast , subjects with low back pain failed to recruit TrA or OI in advance of limb movement with fast movement , and no activity of the abdominal muscles was recorded in the majority of intermediate speed trials . There was no difference between groups for slow movement . CONCLUSION The results indicate that the mechanism of preparatory spinal control is altered in people with lower back pain for movement at a variety of speeds",
"Background There has been increasing focus on factors predicting the development of chronic musculoskeletal disorders . For patients already experiencing chronic non-specific low back pain it is also relevant to investigate which prognostic factors predict recovery . We present the design of a cohort study that aims to determine the course and prognostic factors for recovery in patients with chronic non-specific low back pain . Methods / Design All participating patients were recruited ( Jan 2003-Dec 2008 ) from the same rehabilitation centre and were evaluated by means of ( postal ) question naires and physical examinations at baseline , during the 2-month therapy program , and at 5 and 12 months after start of therapy . The therapy protocol at the rehabilitation centre used a bio-psychosocial approach to stimulate patients to adopt adequate ( movement ) behaviour aim ed at physical and functional recovery . The program is part of regular care and consists of 16 sessions of 3 hours each , over an 8-week period ( in total 48 hours ) , followed by a 3-month self-management program . The primary outcomes are low back pain intensity , disability , quality of life , patient 's global perceived effect of recovery , and participation in work . Baseline characteristics include information on socio-demographics , low back pain , employment status , and additional clinical items status such as fatigue , duration of activities , and fear of kinesiophobia . Prognostic variables are determined for recovery at short-term ( 5 months ) and long-term ( 12 months ) follow-up after start of therapy . Discussion In a routine clinical setting it is important to provide patients suffering from chronic non-specific low back pain with adequate information about the prognosis of their complaint",
"OBJECTIVE To underst and lumbar multifidus ( LM ) muscle activation as a clinical feature to predict patients with low back pain ( LBP ) who are likely to benefit from stabilization ( STB ) exercises . DESIGN Prospect i ve , cohort study . SETTING Outpatient physical therapy clinics . PARTICIPANTS Persons with LBP were recruited for this study . Subjects ( N=25 ) were classified as either eligible to receive STB exercises or ineligible on the basis of current clinical prediction rules . INTERVENTIONS Six weeks of STB treatment . MAIN OUTCOME MEASURES Before and after treatment , subjects underwent rehabilitative ultrasound imaging to quantify LM-muscle activation and completed disability and pain question naires . Analyses were performed to examine the ( 1 ) relation between LM-muscle activation and current clinical features used to predict patients with LBP likely to benefit from STB exercises , ( 2 ) LM-muscle activation between the STB-eligible and STB-ineligible groups before and after STB treatment , and ( 3 ) relation between LM-muscle activation before STB treatment and ( a ) disability and ( b ) pain outcomes after treatment for both groups . RESULTS No relation was found between LM-muscle activation and the number of clinical features . Before STB treatment , LM-muscle activation between the STB-eligible and STB-ineligible groups did not differ . After STB treatment , LM-muscle activation differed between the groups ; however , this interaction was because the LM-muscle activation for the STB-eligible group decreased after treatment while that for the STB-ineligible group increased after treatment . Finally , only the STB-eligible group had a significant reduction in disability following treatment ; however , no relation was found between LM-muscle activation before treatment and ( a ) disability or ( b ) pain outcomes after treatment in the STB-eligible group . CONCLUSIONS LM-muscle activation does not appear to be a clinical feature that predicts patients with LBP likely to benefit from STB exercises",
"Study Design . Prospect i ve , cross-sectional observational study . Objectives . The aim of this study was to determine if there was an association between wasting of psoas and multifidus as observed on MRI scans and the presenting symptoms , reported pathology , pain , or disability of a cohort of patients presenting with unilateral low back pain . Summary of Background Data . Current physiotherapy practice is often based on localized spine stabilizing muscle exercises ; most attention has been focused on transversus abdominus and multifidus with relatively little on psoas . Method . Fifty consecutive patients presenting to a back pain triage clinic with unilateral low back pain lasting more than 12 weeks were recruited . The cross-sectional surface area ( CSA ) of the muscles was measured . Duration of symptoms , rating of pain , self-reported function , and the presence of neural compression were recorded . Results . Data analysis compared the CSA between the symptomatic and asymptomatic sides . There was a statistically significant difference in CSA between the sides ( P in CSA of psoas on the affected side and with the rating of pain ( rho = 0.608 , P nerve root compression ( rho = 0.812 , P duration of symptoms ( rho = 0.886 , P CSA of multifidus and duration of symptoms . Conclusions . Atrophy of multifidus has been used as one of the rationale s for spine stabilization exercises . The evidence of coexisting atrophy of psoas and multifidus suggests that a future area for study should be selective exercise training of psoas , which is less commonly used in clinical practice",
"Study Design . Prospect i ve case-control study of multifidus muscle atrophy in 39 patients with unilateral lumbosacral radiculopathy and lumbosacral disc herniation and 20 controls . Objective . To evaluate quantitatively the asymmetry of multifidus muscles in unilateral lumbosacral radiculopathy with disc herniation ( herniated intervertebral disc ; HIVD ) by using magnetic resonance imaging ( MRI ) . Summary of Background Data . Histologic and morphologic changes of multifidus muscles have been reported in lumbosacral disc herniation , but there are few imaging studies on the changes of multifidus muscles in unilateral radiculopathy . Methods . Bilateral multifidus muscles in L3–L4 , L4–L5 , and L5–S1 levels were detected in fast spin-echo T1 axial MRI images . The total cross-sectional area ( CSA ) of multifidus muscles ( TMA ) and the density of pure muscle CSA ( PMA ) were measured by a computerized analysis program , and the ratios of PMA to TMA ( PMA/TMA ) and the PMA ratios of involved to uninvolved sides ( IMA/UMA ) were calculated . The patients were divided into 2 groups according to the electrodiagnosis results : a radiculopathy ( RAD ) group and an HIVD group without definite radiculopathy . Results . Fourteen patients had lumbosacral radiculopathies ( RAD group ) while 25 had no radiculopathy ( HIVD group ) . No significant difference was found between the RAD and HIVD groups in TMA , PMA , and PMA/TMA . In terms of the criteria for the upper limit of IMA/UMA , 78.6 % in the RAD group had an abnormal IMA/UMA ratio in at least 1 level , compared with 24 % in the HIVD group and 10 % in the control group . Thus , more cases with less muscle volume in the involved side were seen in the RAD group than in the HIVD and control groups . Conclusion . Asymmetry of the multifidus muscles as seen in MRI was a useful finding to assess patients who had unilateral lumbosacral radiculopathy with HIVD . This may reflect the denervation of multifidus muscles in lumbosacral radiculopathy",
"Background Clinical prediction rules ( CPRs ) for treatment selection in musculoskeletal conditions have become increasingly popular . Purpose The purpose s of this review are : ( 1 ) to critically appraise studies evaluating CPRs and ( 2 ) to consider the clinical utility and stage of development of each CPR . Data Sources Pertinent data bases were search ed up to April 2009 . Studies aim ing to develop or evaluate a CPR for treatment response in musculoskeletal conditions were included . Two independent review ers assessed eligibility and extracted method ological data , stage of development , and effect size information . Study Selection / Data Extraction and Synthesis Eighteen studies , evaluating 15 separate CPRs , were included . Fourteen CPRs were at the derivation stage , and all CPRs had been evaluated using a single-arm trial design , thus it is not possible to determine whether the CPRs identify prognosis ( regardless of treatment ) or specifically response to treatment . The CPR at the validation stage investigated spinal manipulative therapy ( SMT ) for low back pain and had been evaluated in 2 separate well-conducted r and omized controlled trials . The first trial demonstrated a clinical ly meaningful effect of the SMT CPR ; the additional effect from SMT in patients “ positive-on-the-rule ” was 15 Oswestry disability units at week 1 and 9 units at week 4 . The second trial showed that the CPR did not generalize to a different clinical setting , including a modified treatment . Limitations Due to differences in methods of reporting and journal publication restraints ( eg , word count restrictions ) , some quality assessment items may have been completed in the included studies , but not captured in this review . Conclusions There is , at present , little evidence that CPRs can be used to predict effects of treatment for musculoskeletal conditions . The principal problem is that most studies use design s that can not differentiate between predictors of response to treatment and general predictors of outcome . Only 1 CPR has been evaluated within an RCT design ed to predict response to treatment . Validation of these rules is imperative to allow clinical application",
"Study Design . A subgroup analysis of patient outcomes from a r and omized controlled trial comparing a Back to Fitness program with usual general practitioner care . Objectives . To test whether patients with high scores on measures of fear-avoidance and distress/depression benefit the most . Summary of Background Data . A fitness program , ongoing since the 1980s , was developed for use in the community and has been shown to be effective in reducing disability . Detailed analyses are needed to identify patient groups who benefit . Recent evidence points to the potentially important role of fear , distress , and depression . Method . Data from 98 patients allocated to normal general practitioner care and 89 patients allocated to a group exercise program were analyzed after categorizing baseline scores on fear-avoidance beliefs ( high/low ) and distress/depression ( at risk/normal ) . The main outcome measure was the Rol and Disability Question naire . Outcomes were compared between the intervention and control groups at 6 weeks , 6 months , and 12 months . Results . High fear-avoiders fared significantly better in the exercise program than in usual general practitioner care at 6 weeks and at 1 year . Low fear-avoiders did not . Patients who were distressed or depressed were significantly better off at 6 weeks , but the benefits were not maintained long-term . Conclusion . Patients with high levels of fear-avoidance beliefs could significantly benefit from the Back to Fitness program . The benefits of the exercise program for patients with high levels of distress/depression appear to be short-term only . Average attendance was only 4 to 5 classes , which may not be sufficient for more recalcitrant cases . Further research is indicated",
"Rehabilitative ultrasound imaging ( RUSI ) is considered a valid method to measure muscle activation in key spinal muscles in asymptomatic subjects . Research measuring muscle activation with RUSI in painful subjects is limited . The aim of this study was to determine if changes in muscle activation from experimentally induced pain can be measured by RUSI . Six male subjects performed tasks known to activate the transverse abdominis ( TrA ) and lumbar multifidus ( LM ) while RUSI measurements of muscle thickness were obtained during control and hypertonic saline conditions . The abdominal draw-in maneuver was used to volitionally activate the TrA and a series of upper extremity lifting tasks were used to automatically activate the LM . Pain was induced by injecting 5 % hypertonic saline into the longissimus muscle adjacent to the LM at the L4 level . The percent change in muscle thickness from rest to contraction represented muscle activation . Activation was significantly less ( p RUSI can be used to measure pain-related changes in deep trunk muscle activation . Future research should include a larger sample size and women",
"OBJECTIVE To investigate the relationship between changes in thickness and EMG activity in the transversus abdominis muscle of healthy subjects and the reliability of ultrasound measurements using different modes and transducers . DESIGN Convenience sampling . BACKGROUND Chronic low back pain is associated with transversus abdominis dysfunction but EMG studies of this muscle are restricted to invasive techniques . Since the thickness of transversus abdominis changes with activity , such changes measured from ultrasound images might provide insight into this muscle 's function non-invasively . In addition , little is known about the comparability of ultrasound measurements from different modes and transducers , nor the reliability of transversus abdominis measurements . METHODS In 9 healthy subjects ( aged 29 - 52 years , four male ) transversus abdominis was studied at rest and during activity ( 5 - 80 % max ) with simultaneous EMG and ultrasound ( M mode , 5 MHz curvilinear transducer ) measurements . Intra-rater reliability for thickness measurements was studied on 13 subjects using 7.5 MHz linear and 5 MHz curvilinear transducers in B and M modes . RESULTS Muscle thickness changes correlated well with EMG activity ( P 0.05 ) . Using 7.5 MHz head , the ICC for B mode was 0.989 and for M mode was 0.981 for between days reliability . The ICC for between transducer reliability was 0.817 . CONCLUSIONS Changes in thickness of transversus abdominis can be used to indicate changes in the electrical activity in this muscle . RELEVANCE Ultrasound scanning can be used in the clinical setting to provide objective information about transversus abdominis function",
"STUDY DESIGN Validation study . OBJECTIVES To investigate the association between changes in electromyographic ( EMG ) signal amplitude and sonographic measures of muscle thickness of 4 abdominal muscles , during 2 clinical tests , in adults with and without lumbopelvic pain . BACKGROUND There is a trend in rehabilitation to use ultrasound imaging ( USI ) to determine the extent of abdominal muscle contraction . However , the literature investigating the relationship between abdominal muscle thickness change and level of activation is inconclusive and has not included clinical ly relevant tasks . METHODS Simultaneous recording from fine-wire EMG and USI was performed for 4 abdominal muscles , in 7 adults with lumbopelvic pain ( mean ± SD age , 29.7 ± 12.0 years ) and 7 adults without lumbopelvic pain ( 32.0 ± 10.6 years ) , during an active straight leg raise ( ASLR ) test and an abdominal drawing-in maneuver ( ADIM ) . Cross-correlation functions and linear regression analyses were used to describe the relationship between the 2 measures . Analyses of variance were used to compare individuals with and without lumbopelvic pain , with an alpha set at .05 . RESULTS Across all muscles , peak cross-correlation values were low ( ASLR , r = 0.28 ± 0.09 ; ADIM , r = 0.35 ± 0.11 ) , and there was large variability in associated time lags ( ASLR , τ = 0.69 ± 2.56 seconds ; ADIM , τ = 0.53 ± 3.75 seconds ) . Regression analyses did not detect a systematic pattern of association between EMG signal amplitude and USI measurements , and analyses of variance revealed no differences between cohorts . CONCLUSION These results suggest a weak relationship between EMG amplitude and abdominal muscle thickness change measured with USI during the ADIM and ASLR , and raise questions about thickness change derived from USI as a measure of muscular activity for the abdominal musculature",
"Introduction Various studies have shown that spine stabilisation exercise therapy elicits improvements in symptoms/disability in patients with chronic non-specific low back pain ( cLBP ) . However , few have corroborated the intended mechanism of action by examining whether clinical improvements ( 1 ) are greater in patients with functional deficits of the targeted muscles and ( 2 ) correlate with post-treatment improvements in abdominal muscle function . Methods Pre and directly after 9 weeks ’ therapy , 32 cLBP patients ( 44.0 ± 12.3 years ) rated their LBP intensity ( 0–10 ) and disability ( 0–24 , Rol and –Morris ; RM ) and completed psychological question naires . At the same timepoints , the voluntary activation of transversus abdominis ( TrA ) , obliquus internus and obliquus externus during “ abdominal-hollowing ” and the anticipatory ( “ feedforward ” ) activation of these muscles during rapid arm movements were measured using M-mode ultrasound with tissue Doppler imaging . Results Pre-therapy to post-therapy , RM decreased from 8.9 ± 4.7 to 6.7 ± 4.3 , and average pain , from 4.7 ± 1.7 to 3.5 ± 2.3 ( each P The ability to voluntarily activate TrA increased by 4.5 % ( P = 0.045 ) whilst the anticipatory activation of the lateral abdominal muscles showed no significant change ( P > 0.05 ) . There was no significant correlation between the change in RM scores after therapy and either baseline values for voluntary ( r = 0.24 , P = 0.20 ) or anticipatory activation ( r = 0.04 , P = 0.84 ) , or their changes after therapy ( voluntary , r = 0.08 , P = 0.66 ; anticipatory , r = 0.16 , P = 0.40 ) . In multiple regression , only a reduction in catastrophising ( P = 0.0003 ) and in fingertip – floor distance ( P = 0.0006 ) made unique contributions to explaining the variance in the reduction in RM scores . Conclusion Neither baseline lateral abdominal muscle function nor its improvement after a programme of stabilisation exercises was a statistical predictor of a good clinical outcome . It is hence difficult to attribute the therapeutic result to any specific effects of the exercises on these trunk muscles . The association between changes in catastrophising and outcome serves to encourage further investigation on larger groups of patients to clarify whether stabilisation exercises have some sort of “ central ” effect , unrelated to abdominal muscle function per se",
"In a retrospective survey , 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987 , were studied for evidence of publication bias . As of May , 1990 , 285 of the studies had been analysed by the investigators , and 52 % of these had been published . Studies with statistically significant results were more likely to be published than those finding no difference between the study groups ( adjusted odds ratio [ OR ] 2.32 ; 95 % confidence interval [ Cl ] 1.25 - 4.28 ) . Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor . An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results , and with increasing sample size . The tendency towards publication bias was greater with observational and laboratory-based experimental studies ( OR = 3.79 ; 95 % Cl = 1.47 - 9.76 ) than with r and omised clinical trials ( OR = 0.84 ; 95 % Cl = 0.34 - 2.09 ) . We have confirmed the presence of publication bias in a cohort of clinical research studies . These findings suggest that conclusions based only on a review of published data should be interpreted cautiously , especially for observational studies . Improved strategies are needed to identify the results of unpublished as well as published studies",
"OBJECTIVE We aim ed to determine to what extent covariate adjustment could affect power in a r and omized controlled trial ( RCT ) of a heterogeneous population with traumatic brain injury ( TBI ) . STUDY DESIGN AND SETTING We analyzed 14-day mortality in 9,497 participants in the Corticosteroid R and omization After Significant Head Injury ( CRASH ) RCT of corticosteroid vs. placebo . Adjustment was made using logistic regression for baseline covariates of two vali date d risk models derived from external data ( International Mission on Prognosis and Analysis of Clinical Trials in Traumatic Brain Injury [ IMPACT ] ) and from the CRASH data . The relative sample size ( RESS ) measure , defined as the ratio of the sample size required by an adjusted analysis to attain the same power as the unadjusted reference analysis , was used to assess the impact of adjustment . RESULTS Corticosteroid was associated with higher mortality compared with placebo ( odds ratio=1.25 , 95 % confidence interval=1.13 - 1.39 ) . RESS of 0.79 and 0.73 were obtained by adjustment using the IMPACT and CRASH models , respectively , which , for example , implies an increase from 80 % to 88 % and 91 % power , respectively . CONCLUSION Moderate gains in power may be obtained using covariate adjustment from logistic regression in heterogeneous conditions such as TBI . Although analyses of RCTs might consider covariate adjustment to improve power , we caution against this approach in the planning of RCTs",
"Intra-abdominal pressure ( IAP ) increases during many tasks and has been argued to increase stability and stiffness of the spine . Although several studies have shown a relationship between the IAP increase and spinal stability , it has been impossible to determine whether this augmentation of mechanical support for the spine is due to the increase in IAP or the abdominal muscle activity which contributes to it . The present study determined whether spinal stiffness increased when IAP increased without concurrent activity of the abdominal and back extensor muscles . A sustained increase in IAP was evoked by tetanic stimulation of the phrenic nerves either unilaterally or bilaterally at 20 Hz ( for 5 s ) via percutaneous electrodes in three subjects . Spinal stiffness was measured as the force required to displace an indentor over the L4 or L2 spinous process with the subjects lying prone . Stiffness was measured as the slope of the regression line fitted to the linear region of the force-displacement curve . Tetanic stimulation of the diaphragm increased IAP by 27 - 61 % of a maximal voluntary pressure increase and increased the stiffness of the spine by 8 - 31 % of resting levels . The increase in spinal stiffness was positively correlated with the size of the IAP increase . IAP increased stiffness at L2 and L4 level . The results of this study provide evidence that the stiffness of the lumbar spine is increased when IAP is elevated",
"BACKGROUND AND PURPOSE The purpose of this r and omized controlled trial was to examine the usefulness of the addition of specific stabilization exercises to a general back and abdominal muscle exercise approach for patients with subacute or chronic nonspecific back pain by comparing a specific muscle stabilization-enhanced general exercise approach with a general exercise-only approach . SUBJECTS Fifty-five patients with recurrent , nonspecific back pain ( stabilization-enhanced exercise group : n=29 , general exercise-only group : n=26 ) and no clinical signs suggesting spinal instability were recruited . METHODS Both groups received an 8-week exercise intervention and written advice ( The Back Book ) . Outcome was based on self-reported pain ( Short-Form McGill Pain Question naire ) , disability ( Rol and -Morris Disability Question naire ) , and cognitive status ( Pain Self-Efficacy Question naire , Tampa Scale of Kinesiophobia , Pain Locus of Control Scale ) measured immediately before and after intervention and 3 months after the end of the intervention period . RESULTS Outcome measures for both groups improved . Furthermore , self-reported disability improved more in the general exercise-only group immediately after intervention but not at the 3-month follow-up . There were generally no differences between the 2 exercise approaches for any of the other outcomes . DISCUSSION AND CONCLUSION A general exercise program reduced disability in the short term to a greater extent than a stabilization-enhanced exercise approach in patients with recurrent nonspecific low back pain . Stabilization exercises do not appear to provide additional benefit to patients with subacute or chronic low back pain who have no clinical signs suggesting the presence of spinal instability",
"Background : Little is known about chronic low back pain ( CLBP ) in combination with widespread musculoskeletal pain ( WMP ) . Objective : This study examined factors that may be common to these conditions , with the objective of detecting factors that could improve the course of these diseases . Design : This was a prospect i ve case control study . Patients and Intervention : A group of patients with CLBP and WMP ( CLBP+WMP group , n=97 ) was compared with a group of individuals who were pain-free and without a history of musculoskeletal problems ( control group , n=97 ) and with a group of patients with CLBP but without WMP ( CLBP-only group , n=52 ) . The mean age of the participants was 42.9 years ( SD=8.74 ) ; 76 % were women , and 24 % were men . Measurements : A total of 74 variables were measured , including sociodemographic , physical , and psychosocial variables . After univariate examination for group differences and analyses of variables available for all 3 groups , logistic regression on selected factors was performed . The α level was set at .05 , but was adjusted to avoid r and omly significant results . Results : For a number of variables , significant differences among the 3 groups were observed . For regression model 1 for the CLBP+WMP and control groups , 4 out of 9 variables showed significant likelihood tests : income ( lower in the WMP group ) , depression , anxiety , and fear-avoidance behavior . For regression model 2 , 2 out of 13 variables showed significant likelihood tests : endurance capacity ( more in the CLBP+WMP group ) and balance capability ( worse in the CLBP+WMP group ) . The models predicted at least 91.2 % of all cases to the correct group . The regression analysis regarding the CLBP+WMP and CLBP-only groups predicted 86.7 % of all cases to the correct group . Three out of 10 variables showed significant likelihood tests : high disability , fear-avoidance behavior , and number of treatments . Limitations : Some variables in testing the patients with WMP and the individuals who were pain-free were not used with the patients with CLBP only . Conclusions : Patients with CLBP and WMP should be examined for indicated physical and psychosocial factors . Therapeutic management should consider them in the early stage of the disease . These findings also might apply to patients with fibromyalgia or myofascial pain",
"STUDY DESIGN Prospect i ve case series . OBJECTIVE To examine the relation between improved disability and changes in abdominal and lumbar multifidus ( LM ) thickness using ultrasound imaging following spinal manipulative therapy ( SMT ) in patients with low back pain ( LBP ) . BACKGROUND Although there is a growing body of literature demonstrating physiologic effects following the application of SMT , few studies have attempted to correlate these changes with clinical ly relevant outcomes . METHODS Eighty-one participants with LBP underwent 2 thrust SMT treatments and 3 assessment sessions within 1 week . Transversus abdominis ( TrA ) , internal oblique ( IO ) , and LM muscle thickness was assessed during each session , using ultrasound imaging of the muscles at rest and during submaximal contractions . The Modified Oswestry Disability Index was used to quantify participants ' improvement in LBP-related disability . Stepwise hierarchical multiple linear regression and repeated- measures analysis of variance were performed to examine the multivariate relationship between change in muscle thickness and clinical improvement over time . RESULTS After controlling for the effects of age , sex , and body mass index , change in contracted LM muscle thickness was predictive of improved disability at 1 week ( P = .02 ) . As expected , larger increases in contracted LM muscle thickness at 1 week were associated with larger improvements in LBP-related disability . Contrary to our hypothesis , significant decreases in both contracted TrA and IO muscle thickness were observed immediately following SMT ; but these changes were transient and unrelated to whether participants experienced clinical improvements . CONCLUSION These findings provide evidence that clinical improvement following SMT is associated with increased thickening of the LM muscle during a submaximal task . LEVEL OF EVIDENCE Prognosis , level 4"
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ABSTRACT Polyphenols have been extensively studied for their antioxidant and anti-inflammatory properties . Recently , their antiglycative actions by oxidative stress modulation have been linked to the prevention of diabetes and associated complications . This article assesses the evidence for polyphenol interventions on glycohemoglobin ( HbA1c ) in non-diabetic , pre-diabetic , and type 2 diabetes mellitus ( T2DM ) subjects . A systematic review of polyphenols ' clinical trials on HbA1c in humans was performed according to the Preferred Reporting Items for Systematic Review and Meta- Analysis . Thirty-six controlled r and omized trials with HbA1c values were included . Polyphenols ( extracts , supplements , and foods ) were supplemented ( 28 mg to 1.5 g ) for 0.7 to 12 months . Combining all subjects ( n = 1954 , mean baseline HbA1c = 7.03 % , 53 mmol/mol ) , polyphenol supplementation significantly ( P lowered HbA1c% by –0.53 ± 0.12 units ( –5.79 ± 0.13 mmol/mol ) . This reduction was significant ( P T2DM subjects , specifically ( n = 1426 , mean baseline HbA1c = 7.44 % , 58 mmol/mol ) , with HbA1c% lowered by –0.21 ± 0.04 units ( –2.29 ± 0.4 mmol/mol ) . Polyphenol supplementation had no significant effect ( P > 0.21 ) in the non-diabetic ( n = 258 , mean baseline HbA1c = 5.47 % , 36 mmol/mol ) and the pre-diabetic subjects ( n = 270 , mean baseline HbA1c = 6.06 % , 43 mmol/mol ) strata : –0.39 ± 0.27 HbA1c% units ( –4.3 ± 0.3 mmol/mol ) , and –0.38 ± 0.31 units ( –4.2 ± 0.31 mmol/mol ) , respectively . In conclusion , polyphenols can successfully reduce HbA1c in T2DM without any intervention at glycemia , and could contribute to the prevention of diabetes complications | [
"BACKGROUND Green tea is one of the most popular beverages in the world . It is believed to have beneficial effects in the prevention and treatment of many diseases , one of which is type 2 diabetes . The aim of the study is to examine the effect of a decaffeinated green tea extract ( GTE ) providing a daily dose of 856 mg of epigallocatechin gallate ( EGCG ) on obese individuals with type 2 diabetes . MATERIAL S AND METHODS The clinical trial was a r and omized , double-blind , placebo-controlled clinical trial conducted from December 2007 through November 2008 . The subjects were r and omly assigned to either receive 1,500 mg of a decaffeinated GTE or placebo daily for 16 weeks . Sixty-eight of 80 subjects , ages 20 - 65 years with BMI > 25 kg/m2 and type 2 diabetes for more than one year , completed this study . Homeostasis model assessment for insulin resistance ( HOMA-IR ) was used as the major outcome measurement . At baseline and after 16 weeks of treatment , anthropometric measurements , fasting glucose , hemoglobin A1C percent ( HbA1C ) , hormone peptides , and plasma lipoproteins were measured from both groups . RESULTS No statistically significant differences were detected between the decaffeinated GTE and placebo groups in any measured variable . A statistically significant within-group 0.4-percent reduction in HbA1C ( from 8.4 to 8.0 % ) was observed after GTE treatment compared to baseline . Within-group comparison also revealed that the GTE group had significant reductions in waist circumference ( WC ) , HOMA-IR index , and insulin level , and a significant increase in the level of ghrelin . Within-group comparison of those in the placebo group showed a significant increase in the level of ghrelin . CONCLUSIONS This study found no statistical difference in any measured variable between the decaffeinated GTE and placebo groups ; however , there were some statistically significant within-group changes detected . More research is required to determine whether a decaffeinated GTE st and ardized for EGCG content will provide any clinical benefits in obese individuals with type 2 diabetes . Clinical Trial Registration NO : NCT00567905",
"In vitro and in vivo animal studies have reported strong insulin-like or insulin-potentiating effects after cinnamon administration . Recently , a human intervention study showed that cinnamon supplementation ( 1 g/d ) strongly reduced fasting blood glucose concentration ( 30 % ) and improved the blood lipid profile in patients with type 2 diabetes . The objective of this study was to investigate the effects of cinnamon supplementation on insulin sensitivity and /or glucose tolerance and blood lipid profile in patients with type 2 diabetes . Therefore , a total of 25 postmenopausal patients with type 2 diabetes ( aged 62.9 + /- 1.5 y , BMI 30.4 + /- 0.9 kg/m2 ) participated in a 6-wk intervention during which they were supplemented with either cinnamon ( Cinnamomum cassia , 1.5 g/d ) or a placebo . Before and after 2 and 6 wk of supplementation , arterialized blood sample s were obtained and oral glucose tolerance tests were performed . Blood lipid profiles and multiple indices of whole-body insulin sensitivity were determined . There were no time x treatment interactions for whole-body insulin sensitivity or oral glucose tolerance . The blood lipid profile of fasting subjects did not change after cinnamon supplementation . We conclude that cinnamon supplementation ( 1.5 g/d ) does not improve whole-body insulin sensitivity or oral glucose tolerance and does not modulate blood lipid profile in postmenopausal patients with type 2 diabetes . More research on the proposed health benefits of cinnamon supplementation is warranted before health cl aims should be made",
"Antioxidants are compounds physiologically produced or provided through the diet with a potential to inhibit the oxidation of important biological molecules , such as proteins , lipids , and DNA . The contemporary Greek diet is still strongly influenced by Mediterranean dietary traditions . The traditional Mediterranean diet ( MD ) is a plant-based diet with apparently beneficial health properties , to which a high antioxidant content may contribute . To explore this issue in detail , a data base of the content of > 200 Greek foods and recipes for a wide spectrum of antioxidant compounds and indices ( flavonoids , proanthocyannidins , other antioxidant microcomponents , and total antioxidant capacity ) was developed . The data base enabled the estimation of antioxidant intakes in Greece using the population -based European Prospect i ve Investigation into Cancer and Nutrition study , in which > 28,000 Greeks participate . The results of this work suggest that the contemporary MD in the Greek population is a rich source of a variety of antioxidants . These data can be used in studies about the relationship between antioxidant intake and chronic diseases in the Greek population",
"Resveratrol is a naturally occurring polyphenolic compound . Numerous animal studies have been reported on its wide-ranging beneficial effects in the biological system including diabetes mellitus ( DM ) . We hypothesized , therefore , that oral supplementation of resveratrol would improve the glycemic control and the associated risk factors in patients with type 2 diabetes mellitus ( T2DM ) . The present clinical study was therefore carried out to test the hypothesis . Sixty-two patients with T2DM were enrolled from Government Headquarters Hospital , Ootacamund , India , in a prospect i ve , open-label , r and omized , controlled trial . Patients were r and omized into control and intervention groups . The control group received only oral hypoglycemic agents , whereas the intervention group received resveratrol ( 250 mg/d ) along with their oral hypoglycemic agents for a period of 3 months . Hemoglobin A(1c ) , lipid profile , urea nitrogen , creatinine , and protein were measured at the baseline and at the end of 3 months . The results reveal that supplementation of resveratrol for 3 months significantly improves the mean hemoglobin A(1c ) ( means ± SD , 9.99 ± 1.50 vs 9.65 ± 1.54 ; P ( mean ± SD , 139.71 ± 16.10 vs 127.92 ± 15.37 ; P ( mean ± SD , 4.70 ± 0.90 vs 4.33 ± 0.76 ; P ( mean ± SD , 75.6 ± 4.6 vs 72.3 ± 6.2 ; P No significant changes in body weight and high-density lipoprotein and low-density lipoprotein cholesterols were observed . Oral supplementation of resveratrol is thus found to be effective in improving glycemic control and may possibly provide a potential adjuvant for the treatment and management of diabetes",
"Diabetes is the most common cause of end-stage renal disease and an important risk factor for morbidity and mortality in dialysis patients . Glycemic control , utilizing serial measurement of glycosylated hemoglobin ( HbA1c ) , is generally recommended to limit end-organ damage , including cardiovascular morbidity and mortality . We , along with others , have previously suggested that HbA1c may not be a reliable measure of glycemic control in dialysis patients , and have therefore explored the use of serum fructosamine ( SF ) as an alternative marker . The objective of this study was to compare HbA1c levels with SF in monitoring glycemic control and associated morbidity ( infection and hospitalization ) in diabetic patients in a large urban hemodialysis ( HD ) center . We enrolled 100 diabetic HD patients and followed them up prospect ively for 3 years . Data on demographics , as well as biochemical and clinical data , including hospitalizations and infections , were recorded . The mean age was 63 years . In all 54 % were women and the majority were African Americans ( 72 % ) . As expected , HbA1c and albumin-corrected fructosamine ( AlbF ) levels were highly correlated and both were significantly associated with serum glucose . AlbF , however , was more highly correlated with mean glucose values when less than 150 mg/dl and was a more useful predictor of morbidity . By univariate logistic regression and by Poisson regression analysis , AlbF , but not HbA1c , was a significant predictor of hospitalization . Additionally , in patients dialyzed by arteriovenous ( AV ) access ( that is , excluding those dialyzed via vascular catheters ) , AlbF , but not HbA1c , was a significant predictor of infection . In conclusion , AlbF is as reliable a marker as HbA1c for glycemic control in diabetic patients on HD , and may be advantageous for patients with serum glucose in a desirable therapeutic range ( morbidity ( hospitalizations and infections ) in diabetic patients on HD",
"Aims /hypothesisThere is conflicting evidence regarding appropriate glycaemic targets for patients with type 2 diabetes . Here , we investigate the relationship between HbA1c and the risks of vascular complications and death in such patients . Methods Eleven thous and one hundred and forty patients were r and omised to intensive or st and ard glucose control in the Action in Diabetes and Vascular disease : Preterax and Diamicron Modified Release Controlled Evaluation ( ADVANCE ) trial . Glycaemic exposure was assessed as the mean of HbA1c measurements during follow-up and prior to the first event . Adjusted risks for each HbA1c decile were estimated using Cox models . Possible differences in the association between HbA1c and risks at different levels of HbA1c were explored using linear spline models . Results There was a non-linear relationship between mean HbA1c during follow-up and the risks of macrovascular events , microvascular events and death . Within the range of HbA1c studied ( 5.5–10.5 % ) , there was evidence of ‘ thresholds ’ , such that below HbA1c levels of 7.0 % for macrovascular events and death , and 6.5 % for microvascular events , there was no significant change in risks ( all p > 0.8 ) . Above these thresholds , the risks increased significantly : every 1 % higher HbA1c level was associated with a 38 % higher risk of a macrovascular event , a 40 % higher risk of a microvascular event and a 38 % higher risk of death ( all p patients with type 2 diabetes , HbA1c levels were associated with lower risks of macrovascular events and death down to a threshold of 7.0 % and microvascular events down to a threshold of 6.5 % . There was no evidence of lower risks below these levels but neither was there clear evidence of harm . Trial Registration : Clinical Trial.gov NCT00145925 Funding : Servier and the National Health and Medical Research Council of Australia ( project grant ID 211086 and programme grant IDs 358395 and 571281",
"Recent evidence suggests that tea from Camellia sinensis ( eg , green , oolong , and black tea ) may have a hypoglycemic effect . We evaluated the ability of an extract of green and black tea to improve glucose control over a 3-month period . A double-blind , placebo-controlled , r and omized multiple-dose ( 0 , 375 , or 750 mg per day for 3 months ) study in adults with type 2 diabetes mellitus not taking insulin was performed . The primary end point was change in glycosylated hemoglobin at 3 months . The 49 subjects who completed this study were predominantly white with an average age of 65 years and a median duration of diabetes of 6 years , and 80 % of them reported using hypoglycemic medication . After 3 months , the mean changes in glycosylated hemoglobin were + 0.4 ( 95 % confidence interval , 0.2 - 0.6 ) , + 0.3 ( 0.1 - 0.5 ) , and + 0.5 ( 0.1 - 0.9 ) in the placebo , 375-mg , and 750-mg arms , respectively . The changes were not significantly different between study arms . We did not find a hypoglycemic effect of extract of green and black tea in adults with type 2 diabetes mellitus",
"OBJECTIVE To assess the effect of dietary flavonoids on cardiovascular disease ( CVD ) risk in postmenopausal women with type 2 diabetes on established statin and hypoglycemic therapy . RESEARCH DESIGN AND METHODS Despite being medicated , patients with type 2 diabetes have elevated CVD risk , particularly postmenopausal women . Although dietary flavonoids have been shown to reduce CVD risk factors in healthy participants , no long-term trials have examined the additional benefits of flavonoids to CVD risk in medicated postmenopausal women with type 2 diabetes . We conducted a parallel- design , placebo-controlled trial with type 2 diabetic patients r and omized to consume 27 g/day ( split dose ) flavonoid-enriched chocolate ( containing 850 mg flavan-3-ols [ 90 mg epicatechin ] and 100 mg isoflavones [ aglycone equivalents)]/day ) or matched placebo for 1 year . RESULTS Ninety-three patients completed the trial , and adherence was high ( flavonoid 91.3 % ; placebo 91.6 % ) . Compared with the placebo group , the combined flavonoid intervention result ed in a significant reduction in estimated peripheral insulin resistance ( homeostasis model assessment of insulin resistance [ HOMA-IR ] −0.3 ± 0.2 ; P = 0.004 ) and improvement in insulin sensitivity ( quantitative insulin sensitivity index [ QUICKI ] 0.003 ± 0.00 ; P = 0.04 ) as a result of a significant decrease in insulin levels ( −0.8 ± 0.5 mU/L ; P = 0.02 ) . Significant reductions in total cholesterol : HDL-cholesterol ( HDL-C ) ratio ( −0.2 ± 0.1 ; P = 0.01 ) and LDL-cholesterol ( LDL-C ) ( −0.1 ± 0.1 mmol/L ; P = 0.04 ) were also observed . Estimated 10-year total coronary heart disease risk ( derived from UK Prospect i ve Diabetes Study algorithm ) was attenuated after flavonoid intervention ( flavonoid + 0.1 ± 0.3 vs. placebo 1.1 ± 0.3 ; P = 0.02 ) . No effect on blood pressure , HbA1c , or glucose was observed . CONCLUSIONS One-year intervention with flavan-3-ols and isoflavones improved biomarkers of CVD risk , highlighting the additional benefit of flavonoids to st and ard drug therapy in managing CVD risk in postmenopausal type 2 diabetic patients",
"Elevated C-reactive protein ( CRP ) , IL-6 and retinol-binding protein 4 ( RBP4 ) levels are associated with insulin resistance and diabetes mellitus . Phytoestrogens ( including lignans and isoflavones ) may enhance the management of diabetes and are hypothesized to act through inflammation pathways . The present study explored the effects of flaxseed-derived lignan on inflammatory factors and RBP4 concentrations in type 2 diabetics , who have higher levels of these biomarkers . Seventy community-dwelling diabetic patients ( twenty-six men and forty-four post-menopausal women ) with mild hypercholesterolaemia completed a r and omized , double-blind , placebo-controlled , cross-over trial of supplementation with flaxseed-derived lignan capsules ( 360 mg/d ) or placebo for 12 weeks , separated by an 8-week wash-out period . The participants maintained their habitual diets and levels of physical activity . Baseline to follow-up concentrations of CRP increased significantly within the placebo group ( 1.42 ( sem 0.19 ) v. 1.96 ( sem 0.22 ) mg/l , P IL-6 or RBP4 ; though IL-6 concentrations increased significantly from baseline to follow-up in both groups ( P = 0.004 and P CRP levels in type 2 diabetics . These results need to be confirmed by further large clinical trials of longer duration",
"For thous and s of years , cinnamon has been used as a traditional treatment in China . However , there are no studies to date that investigate whether cinnamon supplements are able to aid in the treatment of type 2 diabetes in Chinese subjects . We hypothesized cinnamon should be effective in improving blood glucose control in Chinese patients with type 2 diabetes . To address this hypothesis , we performed a r and omized , double-blinded clinical study to analyze the effect of cinnamon extract on glycosylated hemoglobin A(1c ) and fasting blood glucose levels in Chinese patients with type 2 diabetes . A total of 66 patients with type 2 diabetes were recruited and r and omly divided into 3 groups : placebo and low-dose and high-dose supplementation with cinnamon extract at 120 and 360 mg/d , respectively . Patients in all 3 groups took gliclazide during the entire 3 months of the study . Both hemoglobin A(1c ) and fasting blood glucose levels were significantly reduced in patients in the low- and high-dose groups , whereas they were not changed in the placebo group . The blood triglyceride levels were also significantly reduced in the low-dose group . The blood levels of total cholesterol , high-density lipoprotein cholesterol , low-density lipoprotein cholesterol , and liver transaminase remained unchanged in the 3 groups . In conclusion , our study indicates that cinnamon supplementation is able to significantly improve blood glucose control in Chinese patients with type 2 diabetes",
"OBJECTIVE To evaluate the effects of a native herbal tea in patients with type 2 diabetes . DESIGN R and omized , placebo-controlled , single-blind study . SETTING The Metabolic Centre at the University of Alberta Hospitals . SUBJECTS Forty volunteers with type 2 diabetes . INTERVENTIONS After a 1 month \" run-in \" period , subjects drank 250 mL/d of either the herbal tea or a placebo tea for 10 days , and were followed up for a further 4 weeks . OUTCOME MEASURES A responder analysis defined as a 10 % change in mean blood glucose levels based on 4 capillary glucose readings daily . Secondary end points included changes in HbA1c , fructosamine and response to a meal challenge using Ensure . RESULTS The responder analysis showed no benefit from the herbal tea . Fructosamine levels before and after tea therapy decreased significantly in both study groups . Mean HbA1c levels and incremental areas under the glucose curve ( AUC ) in the meal challenge did not change in either study group . These data were reanalysed in hyperglycemic subjects with HbA1c levels greater than 120 % of normal . The responder analysis and HbA1c levels did not change in either group . Mean ( and st and ard deviation ) fructosamine levels , before and after tea therapy , were significantly lower in the herbal tea group than in the placebo tea group ( 361 [ 98 ] versus 338 [ 100 ] micromol/L , p mean AUC during the meal challenge , before versus after tea therapy , was 776 ( 369 ) versus 639 ( 331 ) mmol/L ( p = 0.22 ) in the herbal tea group and 433 ( 125 ) versus 420 ( 173 ) mmol/L ( p = 0.90 ) in the placebo group . CONCLUSIONS Although the responder analysis failed to show an effect of the herbal tea , the data suggest there may be a short-term benefit from the tea in subjects with poor glycemic control",
"Numerous in vitro and animal studies , as well as clinical trials have indicated that plant-derived polyphenols exert beneficial effects on glucose intolerance or type 2 diabetes . This clinical study aim ed to investigate the effects of acacia polyphenol ( AP ) on glucose and insulin responses to an oral glucose tolerance test ( OGTT ) in non-diabetic subjects with impaired glucose tolerance ( IGT ) . A r and omized , double-blind , placebo-controlled trial was conducted in a total of 34 enrolled subjects . The subjects were r and omly assigned to the AP-containing dietary supplement ( AP supplement ; in a daily dose of 250 mg as AP ; n=17 ) or placebo ( n=17 ) and the intervention was continued for 8 weeks . Prior to the start of the intervention ( baseline ) and after 4 and 8 weeks of intervention , plasma glucose and insulin were measured during a two-hour OGTT . Compared with the baseline , plasma glucose and insulin levels at 90 and /or 120 min , as well as the total area under the curve values during the OGTT ( AUC0→2h ) for glucose and insulin , were significantly reduced in the AP group , but not in the placebo group after intervention for 8 weeks . The decline from baseline in plasma glucose and insulin at 90 or 120 min of the OGTT for the AP group was significantly greater compared with that of the placebo group after 8 weeks of intervention . No AP supplement-related adverse side-effects nor any abnormal changes in routine laboratory tests and anthropometric parameters were observed throughout the study period . The AP supplement may have the potential to improve glucose homeostasis in subjects with IGT",
"The objective of this study was to examine the effectiveness of resveratrol in lowering blood glucose in the presence of st and ard antidiabetic treatment in patients with type 2 diabetes , in a r and omized placebo-controlled double-blinded parallel clinical trial . A total of 66 subjects with type 2 diabetes were enrolled in this study and r and omly assigned to intervention group which was supplemented with resveratrol at a dose 1 g/day for 45 days and control group which received placebo tablets . Body weight , blood pressure , fasting blood glucose , haemoglobin A1c , insulin , homeostatic assessment s for insulin resistance , triglycerides , total cholesterol , low density lipoprotein , high density lipoprotein , and markers of liver and kidney damage were measured at baseline and after 45 days of resveratrol or placebo supplementation . Resveratrol treatment significantly decreased systolic blood pressure , fasting blood glucose , haemoglobin A1c , insulin , and insulin resistance , while HDL was significantly increased , when compared to their baseline levels . On the other h and , the placebo group had slightly increased fasting glucose and LDL when compared to their baseline levels . Liver and kidney function markers were unchanged in the intervention group . Overall , this study showed that resveratrol supplementation exerted strong antidiabetic effects in patients with type 2 diabetes",
"Background Flaxseed consumption has been shown to improve blood lipids in humans and flaxseed-derived lignan has been shown to enhance glycemic control in animals . The study aim ed to investigate the effect of a flaxseed-derived lignan supplement on glycemic control , lipid profiles and insulin sensitivity in type 2 diabetic patients . Methodology /Principal Findings This was a r and omized , double-blind , placebo-controlled , cross-over trial and it was conducted between April and December 2006 in Shanghai , China . Seventy-three type 2 diabetic patients with mild hypercholesterolemia were enrolled into the study . Patients were r and omized to supplementation with flaxseed-derived lignan capsules ( 360 mg lignan per day ) or placebo for 12 weeks , separated by an 8-week wash-out period . HbA1c , lipid profiles , insulin resistance index and inflammatory factors were measured . Sixty-eight completed the study and were included in the analyses . The lignan supplement significantly improved glycemic control as measured by HbA1c ( -0.10±0.65 % vs. 0.09±0.52 % , P = 0.001 ) compared to placebo ; however , no significant changes were observed in fasting glucose and insulin concentrations , insulin resistance and blood lipid profiles . Urinary excretion of lignan metabolites ( enterodiol and enterolactone ) was significantly higher after the lignan supplement intervention compared to baseline ( 14.2±18.1 vs. 1.2±2.4 µg/mL , P improvements in glycemic control in type 2 diabetic patients without apparently affecting fasting glucose , lipid profiles and insulin sensitivity . Further studies are needed to vali date these findings and explore the efficacy of lignans on type 2 diabetes . Trial Registration Clinical Trials.gov",
"Studies of the association between polyphenols dietary intake and breast cancer risk have been limited due to the lack of detailed food composition tables . In addition , none has examined this association according to alcohol intake , despite the facts that alcohol is an established risk factor for breast cancer and that the contribution of alcoholic beverages to polyphenol intake varies according to the level of alcohol consumption . Our objectives were ( 1 ) to estimate the associations between breast cancer risk and a wide range of dietary polyphenols using the recently published Phenol-Explorer data base ; and ( 2 ) to evaluate if/how alcohol intake modulates these relationships . 4,141 women from the SU.VI.MAX prospect i ve cohort were followed from 1994 to 2007 ( median followup : 12.6 years ) ; 152 developed a first incident invasive primary breast cancer . Dietary intakes were assessed by repeated 24-h records . The Phenol-Explorer data base was used to estimate polyphenol intake . Multivariable Cox proportional hazards models were used to calculate hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) for quartiles of polyphenol intake . Analyses were stratified by median alcohol intake ( decreased breast cancer risk : hydroxybenzoic acids ( HRQ4vsQ1 = 0.38 , 95 % CI : 0.17–0.86 , Ptrend = 0.005 ) , flavonoids ( 0.35 , 0.17–0.75 , Ptrend = 0.02 ) , flavonols ( 0.36 , 0.18–0.74 , Ptrend = 0.002 ) , catechins ( 0.48 , 0.22–1.05 , Ptrend = 0.02 ) , theaflavins ( 0.42 , 0.19–0.93 , Ptrend = 0.02 ) , and proanthocyanidins ( 0.39 , 0.18–0.84 , Ptrend = 0.02 ) . In contrast , in women with higher alcohol use , intakes of hydroxybenzoic acids ( 2.28 , 1.16–4.49 , Ptrend = 0.04 ) , flavonoids ( 2.46 , 1.23–4.92 , Ptrend = 0.01 ) , anthocyanins ( 2.94 , 1.32–6.53 , Ptrend = 0.01 ) , catechins ( 2.28 , 1.19–4.36 , Ptrend = 0.02 ) , and proanthocyanidins ( 2.98 , 1.40–6.33 , Ptrend = 0.006 ) were associated with increased breast cancer risk . In conclusion , this prospect i ve study suggests that several classes of polyphenols could potentially contribute to breast cancer prevention among non-to-low alcohol drinkers , but some may increase breast cancer risk among women with higher alcohol intake ",
"Serum fructosamine levels can be used to estimate long-term serum glucose values and can be measured in frozen serum . The authors examined whether fructosamine levels were associated with mortality in a cohort of 9,704 white women ( > or = 65 years of age ) recruited from September 1986 to October 1988 at four clinical centers in the United States . A r and om sample of women who had died during a mean of 6 years of follow-up ( n = 55 ) was compared with r and omly selected controls ( n = 276 , 54 of whom had died ) . Fructosamine assays were performed blinded to vital status . Hazard ratios with 95 % confidence intervals were adjusted for age , clinical center , smoking , hypertension , and serum albumin and cholesterol levels . Each st and ard deviation ( 46 micromol ) increase in fructosamine level was associated with a 1.3-fold ( 95 % confidence interval ( CI ) 1.0 - 1.6 , p = 0.04 ) increased rate of all-cause mortality , including a 1.5-fold ( 95 % CI 1.0 - 2.1 , p = 0.03 ) increase in cardiovascular disease mortality . Elevated fructosamine levels ( > 285 micromol/liter ) were associated with a 4.3-fold ( 95 % CI 1.6 - 12 , p = 0.004 ) increased rate of cardiovascular mortality ; in women without a history of diabetes , the hazard ratio was 4.6 ( 95 % CI 1.3 - 16 , p = 0.02 ) . Fructosamine level , or another indicator of glycemia , should be included when the risk of cardiovascular disease among older patients is evaluated",
"We conducted a r and omised single centre double blind cross over clinical trial to investigate the effects of a herbal tea containing Salacia reticulata ( Kothala Himbutu tea ) in patients with type II diabetes mellitus . Fifty-one patients with type II diabetes mellitus for longer than 6 months and with evidence of stable glycaemic control over the preceding 6 months ( as assessed by HbA1C ) participated in the study . They were r and omised to receive a st and ard preparation of Kothala Himbutu tea for 3 months followed by placebo in similar tea bags for a further 3 months ( n = 28 ) or in reverse order ( n = 23 ) . All patients received detailed advice on diet , exercise and lifestyle modification . HbA1C was measured at recruitment , at 3 months and on completion of the study at 6 months . Liver and renal functions were assessed biochemically at baseline , at 3 and 6 months and adverse events were recorded . There were no significant differences between the two groups in age , body mass index , male/female ratio , glycaemic control and baseline laboratory tests . All patients completed both arms of the trial . The HbA1C at the end of drug treatment was significantly lower than after treatment with placebo ( 6.29 + /- S.D. 1.02 versus 6.65 + /- S.D. 1.04 ; P = 0.008 ) . A statistically significant fall in HBA1c was seen with the active drug compared to a rise in HbA1C with the placebo group ( 0 . 54 + /- S.D. 0.93 ) versus -0.3 + /-S.D. 1.05 ; P daily mean dose of Glibenclamide fell by 1.89 ( S.D. 6.2 ) mg in the drug treated group but rose by 2.25 mg in the placebo treated group ( P = 0.07 ) . The differences in the metformin dose were not significantly significant in the two groups . We conclude that Kothala Himbutu tea is an effective and safe treatment for type 2 diabetes",
"Patients with type 2 diabetes are at considerable risk of excessive morbidity and mortality from cardiovascular disease ( CVD ) . We investigated the clinical effectiveness of Pycnogenol , a flavonoid-rich dietary supplement , in reducing antihypertensive medication use and CVD risk factors in subjects with type 2 diabetes . Forty-eight individuals were enrolled in a r and omized , double-blind , placebo-controlled trial with parallel-group design . Patients were diagnosed with both type 2 diabetes and mild to moderate hypertension and were undergoing treatment with angiotensin-converting enzyme ( ACE ) inhibitors . Subjects were r and omly assigned to receive either Pycnogenol pill ( 125 mg daily ) or matched placebo for 12 weeks . According to the values of blood pressure ( BP ) measured at 2-week intervals , the pretrial ACE inhibitor dosage was left unchanged , reduced by 50 % , or brought back to the pretrial dosage until a stable BP was obtained . Fasting plasma glucose , low-density lipoprotein ( LDL ) cholesterol , glycosylated hemoglobin ( HbA1c ) , serum endothelin-1 , and urinary albumin were evaluated monthly . Pycnogenol treatment achieved BP control in 58.3 % of subjects at the end of the 12 weeks with 50 % reduction in individual pretrial dose of ACE-inhibitors ( P Plasma endothelin-1 decreased by 3.9 pg/mL in Pycnogenol-treated group vs 0.5 pg/mL increase in control group ( P Mean HbA1c dropped by 0.8 % in Pycnogenol-treated group ( P Fasting plasma glucose declined by 23.7 mg/dL in Pycnogenol-treated group vs 5.7 mg/dL in control group ( P Low-density lipoprotein cholesterol improved significantly in Pycnogenol-treated group , declining by 12.7 mg/dL ( P urinary albumin level was observed at week 8 compared with the control group ( P Pycnogenol result ed in improved diabetes control , lowered CVD risk factors , and reduced antihypertensive medicine use vs controls",
"Oxidative stress is increased postpr and ially and during long-term hyperglycemia in type 2 diabetic patients who present with poor response to glibenclamide . This study was design ed to evaluate the effects of the antioxidant flavonoid silymarin in improving long-term and postpr and ial glycemic and weight control in type 2 diabetic patients treated with glibenclamide . Using a r and omized , double-blind , placebo-controlled design , 59 type 2 diabetic patients , previously maintained on 10 mg/day glibenclamide and diet control , with poor glycemic control , were r and omized into three groups : the first two groups were treated with either 200 mg/day silymarin or placebo as adjuncts to glibenclamide , and the third group was maintained on glibenclamide alone for 120 days . Fasting and 4-hour postpr and ial plasma glucose , glycated hemoglobin ( HbA(1c ) ) , and body mass index ( BMI ) were evaluated at baseline and after 120 days . Compared with placebo , silymarin treatment significantly reduced both fasting and postpr and ial plasma glucose excursions , in addition to significantly reducing HbA(1c ) levels and BMI after 120 days . No significantly different effects were observed for placebo compared to glibenclamide alone . In conclusion , adjunct use of silymarin with glibenclamide improves the glycemic control targeted by glibenclamide , during both fasting and postpr and ially , an effect that may be related to increased insulin sensitivity in peripheral tissues",
"BACKGROUND AND AIMS Epidemiological data have shown an inverse association between the consumption of polyphenol-rich foods and the risk of cardiovascular disease or overall mortality . A comprehensive estimation of individual polyphenol intake in nutritional cohorts is needed to gain a better underst and ing of this association . The aim of this study was to estimate the quantitative intake of polyphenols and the major dietary sources in the PREDIMED ( PREvención con DIeta MEDiterránea ) cohort using individual food consumption records . METHODS AND RESULTS The PREDIMED study is a large , parallel-group , multicentre , r and omised , controlled 5-year feeding trial aim ed at assessing the effects of the Mediterranean diet on the primary prevention of cardiovascular disease . A total of 7200 participants , aged 55 - 80 years , completed a vali date d 1-year food frequency question naire ( FFQ ) at baseline . Polyphenol consumption was calculated by matching food consumption data from the FFQ with the recently developed Phenol-Explorer data base on polyphenol content in foods . The mean total polyphenol intake was 820 ± 323 mg day⁻¹ ( 443 ± 218 mg day⁻¹ of flavonoids and 304 ± 156 mg day⁻¹ of phenolic acids ) . Hydroxycinnamic acids were the phenolic group with the highest consumption and 5-caffeoylquinic acid was the most abundantly ingested individual polyphenol . The consumption of olives and olive oil was a differentiating factor in the phenolic profile of this Spanish population compared with other countries . CONCLUSION In Mediterranean countries , such as Spain , the main dietary source of polyphenols is coffee and fruits , but the most important differentiating factor with respect to other countries is the consumption of polyphenols from olives and olive oil ",
"Curcumin , the yellow pigment from the rhizoma of Curcuma longa , is a widely studied polyphenolic compound which has a variety of biological activity as anti-inflammatory and antioxidative agent . Genistein one of the flavonoids found in soybean and chickpeas inhibits DNA str and breaks acting as a direct scavenger of reactive oxygen species . Human serum albumin ( HSA ) with high affinity binding sites is a major transporter for delivering several endogenous compounds and drugs in vivo . The aim of this study was to examine the interactions of curcumin and genistein with human serum albumin at physiological conditions , using constant protein concentration and various pigment contents . FTIR , UV-Visible , CD and fluorescence spectroscopic methods were used to analyse drug binding mode , the binding constant and the effects of pigment complexation on HSA stability and conformation . Structural analysis showed that curcumin and genistein bind HSA via polypeptide polar groups with overall binding constants of K(curcumin)=5.5 (+/-0.8)x10(4)M(-1 ) and K(genistein)=2.4 (+/-0.40)x10(4)M(-1 ) . The number of bound pigment ( n ) is 1.33 for curcumin and 1.49 for genistein . The HSA conformation was altered by pigment complexation with reduction of alpha-helix and increase of r and om coil and turn structures suggesting a partial protein unfolding",
"OBJECTIVES Our goal was to test feasibility and efficacy of a dietary intervention based on daily intake of flavanol-containing cocoa for improving vascular function of medicated diabetic patients . BACKGROUND Even in fully medicated diabetic patients , overall prognosis is unfavorable due to deteriorated cardiovascular function . Based on epidemiological data , diets rich in flavanols are associated with a reduced cardiovascular risk . METHODS In a feasibility study with 10 diabetic patients , we assessed vascular function as flow-mediated dilation ( FMD ) of the brachial artery , plasma levels of flavanol metabolites , and tolerability after an acute , single-dose ingestion of cocoa , containing increasing concentrations of flavanols ( 75 , 371 , and 963 mg ) . In a subsequent efficacy study , changes in vascular function in 41 medicated diabetic patients were assessed after a 30-day , thrice-daily dietary intervention with either flavanol-rich cocoa ( 321 mg flavanols per dose ) or a nutrient-matched control ( 25 mg flavanols per dose ) . Both studies were undertaken in a r and omized , double-masked fashion . Primary and secondary outcome measures included changes in FMD and plasma flavanol metabolites , respectively . RESULTS A single ingestion of flavanol-containing cocoa was dose-dependently associated with significant acute increases in circulating flavanols and FMD ( at 2 h : from 3.7 + /- 0.2 % to 5.5 + /- 0.4 % , p flavanol-containing cocoa increased baseline FMD by 30 % ( p FMD upon ingestion of flavanol-containing cocoa continued to be manifest throughout the study . Treatment was well tolerated without evidence of tachyphylaxia . Endothelium-independent responses , blood pressure , heart rate , and glycemic control were unaffected . CONCLUSIONS Diets rich in flavanols reverse vascular dysfunction in diabetes , highlighting therapeutic potentials in cardiovascular disease",
"AIM OF THE STUDY The aim of this r and omized and double blinded pilot clinical trial was to investigate the anti-diabetic efficacy of the Rauvolfia-Citrus ( RC ) tea in humans . We have earlier shown that a combination of calorie-restriction and chronic administration of the RC tea to the genetic diabetic ( BKS-db ) mice result ed in the normalization of blood sugar , reduction in lipid accumulated in the mice eyes and prevention of the degeneration of the otherwise brittle BKS-db pancreas . The tea is made by boiling foliage of Rauvolfia vomitoria and fruits of Citrus aurantium and is used to treat diabetes in Nigerian folk medicine . MATERIAL S AND METHODS The RC tea was produced using the Nigerian traditional recipe and tested in the traditional dosage on 23 Danish type 2 diabetes ( T2D ) patients . The participants were divided into two equivalent groups after stratification by sex , age and BMI , in a 4-month double-blinded , placebo-controlled and r and omized clinical trial . Most of the study subjects ( 19/23 ) were using oral anti-diabetic agents ( OADs ) . Mean disease duration was 6±4.6 years , mean age was 64±7 years and mean BMI was 28.7±3.8 kg/m(2 ) . Prior to starting the treatment , the participants received individual dietician consultations . RESULTS At the end of the 4-month treatment period , the treated group showed an 11 % decrease in 2-h postpr and ial plasma glucose relative to the 3 % increase in the placebo group ( p=0.004 ) . The improvement in blood glucose clearance with RC tea treatment was reflected in a 6 % reduction in HbA(1c ) ( p=0.02 ) and in a 10 % reduction in fasting plasma glucose ( p=0.02 ) , when comparing the post 4-month treatment to pre-treatment baseline values . Though the basal levels of phosphorylated acetyl CoA carboxylase enzyme in skeletal muscle were significantly reduced in the treated group ( p=0.04 ) , as compared to the placebo , only the pattern of reductions in the tissue fatty acids ( FAs ) differed in the two groups . While all types of FAs were reduced in placebo , only saturated ( SFA ) and monounsaturated ( MUFA ) FAs were reduced with treatment . Interestingly , a modest increase in the polyunsaturated FAs fraction was observed in the RC treated group . In addition , the reduction in SFA and MUFA with RC tea treatment came solely from the triglyceride fractions , as there was an increase in the skeletal muscle phospholipids . CONCLUSIONS Chronic administration of the RC tea to overweight T2D on OADs caused significant improvements in markers of glycaemic control and modifications to the fatty acid profile of skeletal muscle , without adverse effects or hypoglycaemia . Further exploration of the anti-diabetic effects of the RC tea is warranted",
"Numerous studies have shown that resveratrol ( RES ) exerts anti-inflammatory effects but human trials evidencing these effects in vivo are limited . Furthermore , the molecular mechanisms triggered in humans following the oral intake of RES are not yet understood . Therefore , the purpose of this study was to investigate the molecular changes in peripheral blood mononuclear cells ( P BMC s ) associated to the one-year daily intake of a RES enriched ( 8 mg ) grape extract ( GE-RES ) in hypertensive male patients with type 2 diabetes mellitus ( T2DM ) . We used microarrays and RT-PCR to analyze expression changes in genes and microRNAs ( miRs ) involved in the inflammatory response modulated by the consumption of GE-RES in comparison to a placebo and GE lacking RES . We also examined the changes in several serobiochemical variables , inflammatory and fibrinolytic markers . Our results showed that supplementation with GE or GE-RES did not affect body weight , blood pressure , glucose , HbA1c or lipids , beyond the values regulated by gold st and ard medication in these patients . We did not find either any significant change on serum inflammatory markers except for a significant reduction of ALP and IL-6 levels . The expression of the pro-inflammatory cytokines CCL3 , IL-1β and TNF-α was significantly reduced and that of the transcriptional repressor LRRFIP-1 increased in P BMC s from patients taking the GE-RES extract . Also , a group of miRs involved in the regulation of the inflammatory response : miR-21 , miR-181b , miR-663 , miR-30c2 , miR-155 and miR-34a were found to be highly correlated and altered in the group consuming the GE-RES for 12 months . Our results provide preliminary evidence that long-term supplementation with a grape extract containing RES downregulates the expression of key pro-inflammatory cytokines with the involvement of inflammation-related miRs in circulating immune cells of T2DM hypertensive medicated patients and support a beneficial immunomodulatory effect in these patients",
"Context Several studies suggest that blood glucose levels are associated with cardiovascular disease , even at blood glucose values that do not meet diagnostic criteria for diabetes . Contribution Among adult residents of Norfolk , United Kingdom , there was a continuous relationship between hemoglobin A1c levels and cardiovascular disease and total mortality . This relationship was apparent even among persons without diabetes . Implication s These observations justify the need for studies that address whether improvements in glycemic control might improve health outcomes in persons who do not have diabetes . The Editors Diabetes mellitus is of major and increasing global public health importance ( 1 ) . Persons with diabetes are at increased risk for premature disability and death associated with vascular , renal , retinal , and neuropathic complications . Raised fasting and postchallenge blood glucose levels in an oral glucose tolerance test are used to diagnose diabetes . The diagnostic threshold is based on the shape of the risk curve between glucose levels and specific microvascular complications of diabetes ( 2 - 6 ) . Diabetes also increases the risk for macrovascular diseases , such as coronary heart disease and stroke ( 7 ) . In contrast to microvascular disease , increasing evidence suggests that the relationship between blood glucose level and macrovascular disease is continuous and does not have an obvious threshold ( 2 , 8 , 9 ) . Hemoglobin A1c concentration is an indicator of average blood glucose concentrations over the preceding 3 months ; it is useful for characterizing dysglycemia in population studies because it is simpler to perform than the oral glucose tolerance test ( 10 ) . In a 3-year follow-up of men in a prospect i ve study , we previously reported that hemoglobin A1c concentrations were related to cardiovascular disease and all-cause mortality ( 11 ) . However , we had insufficient power to examine risk relationships at concentrations close to the diagnostic threshold of 7 % or to examine the relationship in women . We report the relation between hemoglobin A1c concentrations and fatal and nonfatal coronary heart disease , cardiovascular disease events , and all-cause mortality in men and women after an average of 6 years of follow-up . Methods The European Prospect i ve Investigation into Cancer in Norfolk ( EPICNorfolk ) is a prospect i ve population study of 25 623 men and women who were between 40 and 79 years of age and who resided in Norfolk , United Kingdom . Participants were recruited from general practice registers . Information on the recruitment process is available elsewhere ( 12 ) . Between 1993 and 1997 , participants completed a health and lifestyle question naire . Participants were asked whether a doctor had ever told them that they have any of the conditions contained in a list that included diabetes , heart attack , and stroke . People with known diabetes were defined as those who responded yes to the diabetes option of this question . Smoking history was derived from responses ( yes or no ) to the questions : Have you ever smoked as much as 1 cigarette a day for as long as a year ? and Do you smoke cigarettes now ? At a clinic , trained nurses performed a health examination for each participant . Body mass index was estimated as weight (kg)/height ( m2 ) , and waist-to-hip ratio was determined by measurements of the circumference of the waist and hips . Blood pressure was measured by using an Accutorr ( Data scope , Mahwah , New Jersey ) noninvasive blood pressure monitor after the participant had been seated for 5 minutes . The mean of 2 readings was used for analysis . Nonfasting blood sample s were taken ; sample s for assay were stored in a refrigerator at 4 C until transport within 1 week of sampling to the Department of Clinical Biochemistry , University of Cambridge . Starting in 1995 , hemoglobin A1c was measured on fresh EDTA blood sample s by using high-performance liquid chromatography ( BioRad Diamat Automated Glycosylated Haemoglobin Analyser , Hemel Hempstead , United Kingdom ) . We report results for follow-up to January 2003 , an average of about 6 years . All participants were flagged for death certification at the Office of National Statistics ; vital status was obtained for the entire cohort . Trained nosologists coded death certificates according to the International Classification of Diseases , Ninth or Tenth Revisions ( ICD-9 or ICD-10 ) . Cardiovascular death ( stroke , coronary heart disease , and other vascular causes ) was defined as those whose underlying cause of death was coded as ICD-9 400448 or ICD-10 I10I79 . Death from coronary heart disease was defined as those whose cause of death was coded as ICD-9 410414 or ICD-10 I22I25 . Participants admitted to a hospital were identified by their National Health Service number . Hospitals were linked to the East Norfolk Health Authority data base , which identifies all hospital contacts throughout Engl and and Wales for Norfolk residents . We used the same ICD diagnostic codes described in the preceding paragraphs to ascertain hospital episodes of cardiovascular disease and coronary heart disease in our cohort . Participants were identified as having a coronary heart disease event during follow-up if they had a hospital admission or died with coronary heart disease as the cause of death . Of the coronary heart disease events identified , 21 % ( 112 of 529 ) were fatal ; of the cardiovascular disease events , 23 % ( 197 of 806 ) were fatal . In men , 24 % ( 76 of 321 ) of deaths were attributed to heart disease and 29 % ( 117 of 321 ) were attributed to cardiovascular disease . In women , 18 % ( 36 of 200 ) of deaths were attributed to heart disease and 35 % ( 70 of 200 ) were attributed to cardiovascular causes . The Norwich Ethics Committee approved the study , and participants gave signed informed consent . Statistical Analysis These analyses , undertaken by using SPSS software , version 10.0 ( SPSS , Inc. , Chicago , Illinois ) , included 10 232 men and women age 45 to 79 years who completed the health and lifestyle question naire and had available hemoglobin A1c measurements . We divided the cohort into 7 categories on the basis of baseline data : known diabetes , high likelihood of previously undiagnosed diabetes ( no personal history of diabetes but a hemoglobin A1c concentration 7 % ) , and hemoglobin A1c concentrations in 0.5percentage point intervals ( risk factor distributions and then coronary heart disease , cardiovascular disease , and all-cause mortality rates by hemoglobin A1c and diabetes category . Age-adjusted odds ratios were calculated by using logistic regression models . We used a Cox proportional hazards model to determine the independent contribution of hemoglobin A1c to total mortality and cardiovascular and coronary heart disease after adjustment for age , body mass index , waist-to-hip ratio , systolic blood pressure , blood cholesterol concentrations , cigarette smoking , and history of heart attack or stroke . Participants with missing baseline data for 1 or more risk factors ( 130 men and 186 women ) were excluded from the multivariate analyses . Role of the Funding Sources The funding sources had no role in the design , conduct , and reporting of the study or in the decision to su bmi t the manuscript for publication . Results Table 1 presents characteristics of the participants according to hemoglobin A1c concentration and self-reported diabetes . Those with known diabetes had higher mean ( SD ) hemoglobin A1c concentrations ( 8.0 % 1.9 % ) than the rest of the study sample ( 5.3 % 0.7 % ) . They were older and had a higher body mass index , waist-to-hip ratio , and systolic blood pressure ; they were also more likely to report having had a previous heart attack or stroke . Participants with probable but previously undiagnosed diabetes ( hemoglobin A1c 7 % ) shared these characteristics . Mean risk factor levels rose with increasing concentration of hemoglobin A1c less than 7 % . Table 1 . Distribution of Variables by Hemoglobin A1c Concentration and Known Diabetes in 4662 Men and 5570 Women Age 45 to 79 Years ( European Prospect i ve Investigation into Cancer in Norfolk , 1995 to 1997 ) Table 2 shows adjusted odds ratios for hemoglobin A1c concentrations , diabetes status , and outcomes . Persons with known or undiagnosed diabetes had a greater risk for all-cause mortality and cardiovascular or coronary heart disease than those without diabetes . Risk for coronary heart or cardiovascular disease and total mortality increased throughout the whole range of hemoglobin A1c concentrations ; those with hemoglobin A1c concentrations less than 5 % had the lowest rates . For men , a gradient of increasing rates through the distribution was apparent for all end points . For women , odds ratios for cardiovascular or coronary heart disease did not increase significantly until the hemoglobin A1c concentration reached 6 % ; odds ratios were very high in women with concentrations greater than 7 % . Table 2 . Rates and Age-Adjusted Relative Risks for Total Coronary Heart Disease Events , Cardiovascular Disease Events , and All-cause Mortality by Category of Hemoglobin A1c Concentration and Known Diabetes in 4462 Men and 5570 Women Age 45 to 79 Years ( European Prospect i ve Investigation into Cancer in Norfolk , 1995 to 2003 ) Table 3 shows outcomes after adjustment for age alone and then after adjustment for age and other risk factors . In men , known diabetes predicted coronary heart and cardiovascular disease events and total mortality with approximate 2-fold relative risks . These relative risks were only slightly attenuated after adjustment for known risk factors . In women , known diabetes status predicted an approximate 5-fold increase in risk for coronary heart and 3-fold increase in risk for cardiovascular disease events ; these increases were attenuated after adjustment for known risk factors to 3-fold and 2-fold risk , respectively . In men and women , hemoglobin A1c concentrations predicted an increased risk for",
"We have recently reported that ingestion of Ginkgo biloba extract ( EGb 761 ) ( a ) significantly reduced collagen-induced platelet aggregation and thromboxane B2 ( TXB2 ) production in both non-diabetic individuals as well as those with type 2 diabetes mellitus ( T2DM ) , ( b ) significantly reduced platelet malondialdehyde ( MDA ) , an index of lipid peroxidation , in non-diabetic subjects . In the present study we report that ingestion of EGb 761 ( 120 mg daily for 3 months ) , significantly decreased platelet MDA-thiobarbituric acid reacting substances ( TBARS ) ( 41 + /- 9 pmol/10(7 ) platelets versus 30 + /- 11 pmol/10(7 ) platelets ) ( p T2DM subjects with normal cholesterol levels ( total cholesterol , 164 + /- 22 mg/dl ; age , 54 + /- 9 years ; BMI , 35.0 + /- 8.8 kg/m2 , n = 12 ) . In T2DM subjects with high cholesterol ( total cholesterol , 218 + /- 15 mg/dl ; age , 52 + /- 5 years ; BMI , 36.2 + /- 6.6 kg/m2 , n = 7 ) , EGb 761 ingestion reduced the platelet TBARS from 29 + /- 9 to 22 + /- 9 pmol/10(7 ) platelets ( p EGb 761 did not alter platelet counts it is concluded that EGb 761 , probably due to the flavonoid fraction , reduced the TBARS by inhibiting cyclooxygenase (COX)-1-mediated arachidonic acid oxygenation or by reducing the arachidonic acid pool . This is likely to lead to a reduction of platelet hyperactivity , a significant contributor to the development of cardiovascular disease in T2DM patients . Because of other reported beneficial properties of EGb 761 , such as stimulation of pancreatic beta-cell function in T2DM subjects with pancreatic exhaustion , it appears that T2DM subjects might benefit from ingesting EGb 761 as a dietary supplement"
] | 41162f9a-06ff-11f0-808a-c43d1ab1c353 |
Oropharyngeal colostrum ( OC ) is a novel feeding strategy to prevent complications of prematurity . A meta- analysis was conducted to investigate whether very low birth weight infants ( VLBWs ) can benefit from OC . R and omized controlled trials ( RCTs ) were search ed from Embase , PubMed , Web of Science , and Cochrane Central Register of Controlled Trials from the date of inception until May 2019 . RCTs were eligible if they used OC therapy on VLBW infants . The primary outcomes included ventilator-associated pneumonia ( VAP ) , necrotizing enterocolitis ( NEC ) , bronchopulmonary dysplasia ( BPD ) , late-onset sepsis , and death . The secondary outcomes included the time of full enteral feeding and the length of stay . Eight RCTs involving 682 patients ( OC group : 332 ; non-OC group : 350 ) were included in the meta- analysis . The results suggested that OC was associated with a significantly reduced incidence of VAP [ odds ratio ( OR ) = 0.39 , 95 % confidence interval ( CI ) : 0.17–0.88 , P = 0.02 ] and full enteral feeding days ( mean difference = −2.66 , 95 % CI : −4.51 to −0.80 , P = 0.005 ) , a potential significance of NEC ( OR = 0.51 , 95 % CI : 0.26–0.99 , P = 0.05 ) , a trend toward downregulating mortality ( OR = 0.60 , 95 % CI : 0.34–1.08 , P = 0.09 ) and proven sepsis ( OR = 0.64 , 95 % CI : 0.40–1.01 , P = 0.06 ) . OC could significantly reduce the occurrence of VAP , and consequently , its routine use should be considered for VLBWs to prevent infectious diseases . OC significantly reduces the occurrence of VAP and NEC in VLBW infants . OC may reduce the incidence of VAP and NEC by increasing IgA levels . Early OC therapy for mechanical ventilation of low-weight infants may prevent the occurrence of VAP . OC significantly reduces the occurrence of VAP and NEC in VLBW infants . OC may reduce the incidence of VAP and NEC by increasing IgA levels . Early OC therapy for mechanical ventilation of low-weight infants may prevent the occurrence of VAP | [
"Objective : Oral colostrum priming ( OCP ) after birth in preterm infants is associated with improved weight gain and modification of the oral immunomicrobial environment . We hypothesized that OCP would modify salivary immune peptides and the oral microbiota in preterm infants . Study design : We conducted a prospect i ve , r and omized clinical trial to determine the effects of OCP on salivary immune peptide representation in preterm infants ( Saliva sample s were collected before and after OCP . Salivary immune peptide representation was determined via mass spectroscopy . Oral microbiota representation was determined via sequencing of the 16S rRNA gene . Results : Neonates who received OCP ( n=48 ) had a 16-day reduction in the median length of hospitalization as compared with infants who did not receive OCP ( n=51 ) . No differences in salivary immune peptide sequence representation before OCP between groups were found . Longitudinal changes in peptides were detected ( lysozyme C , immunoglobulin A , lactoferrin ) but were limited to a single peptide difference ( α-defensin 1 ) between primed and unprimed infants after OCP . We found no difference in microbial diversity between treatment groups at any time point , but diversity decreased significantly over time in both groups . OCP treatment marginally modified oral taxa with a decline in abundance of Streptococci in the OCP group at 30 days of life . Conclusions : OCP had neither an effect on the salivary peptides we examined nor on overall oral bacterial diversity and composition . Infants who received OCP had a reduced length of hospitalization and warrants further investigation",
"OBJECTIVE To determine the rates , characteristics , risk factors , and outcomes of ventilator-associated pneumonia ( VAP ) in extremely preterm neonates in a neonatal intensive care unit ( NICU ) . METHODS A prospect i ve cohort study was conducted at the St Louis Children 's Hospital on all patients who had birth weight or=48 hours from October 2000 to July 2001 . Extremely preterm neonates were defined as neonates with estimated gestational age ( EGA ) The primary outcome was the development of VAP . Secondary outcomes were death and NICU length of stay ( LOS ) . Multiple logistic regression was performed to determine independent predictors for VAP and mortality . RESULTS A total of 229 patients were enrolled . Sixty-seven ( 29 % ) had EGA Nineteen episodes of VAP occurred in 19 ( 28.3 % ) of 67 mechanically ventilated patients . VAP rates were 6.5 per 1000 ventilator days for patients with EGA or=28 weeks . By multivariate analysis , bloodstream infection before VAP ( adjusted odds ratio : 3.5 ; 95 % confidence interval [ CI ] : 1.2 - 10.8 ) was an independent risk factor for VAP after adjustment for the duration of endotracheal intubation . Ventilator-associated pneumonia ( adjusted odds ratio : 3.4 ; 95 % CI : 1.2 - 12.3 ) was an independent predictor of mortality . A strong association between VAP and mortality was observed in neonates who stayed in the NICU > 30 days ( relative risk : 8.0 ; 95 % CI : 1.9 - 35.0 ) . Patients with VAP also had prolonged NICU LOS ( median : 138 vs 82 days ) . CONCLUSIONS VAP occurred at high rates in extremely preterm neonates and was associated with increased mortality . Additional studies are needed to develop interventions to prevent VAP in NICU patients",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Purpose To evaluate the potential preventive effect of probiotics on ventilator-associated pneumonia ( VAP ) . Methods This was an open-label , r and omized , controlled multicenter trial involving 235 critically ill adult patients who were expected to receive mechanical ventilation for ≥48 h. The patients were r and omized to receive ( 1 ) a probiotics capsule containing live Bacillus subtilis and Enterococcus faecalis ( Medilac-S ) 0.5 g three times daily through a nasogastric feeding tube plus st and ard preventive strategies or ( 2 ) st and ard preventive strategies alone , for a maximum of 14 days . The development of VAP was evaluated daily , and throat swabs and gastric aspirate were cultured at baseline and once or twice weekly thereafter . Results The incidence of microbiologically confirmed VAP in the probiotics group was significantly lower than that in the control patients ( 36.4 vs. 50.4 % , respectively ; P = 0.031 ) . The mean time to develop VAP was significantly longer in the probiotics group than in the control group ( 10.4 vs. 7.5 days , respectively ; P = 0.022 ) . The proportion of patients with acquisition of gastric colonization of potentially pathogenic microorganisms ( PPMOs ) was lower in the probiotics group ( 24 % ) than the control group ( 44 % ) ( P = 0.004 ) . However , the proportion of patients with eradication PPMO colonization on both sites of the oropharynx and stomach were not significantly different between the two groups . The administration of probiotics did not result in any improvement in the incidence of clinical ly suspected VAP , antimicrobial consumption , duration of mechanical ventilation , mortality and length of hospital stay . Conclusion Therapy with the probiotic bacteria B. Subtilis and E. faecalis are an effective and safe means for preventing VAP and the acquisition of PPMO colonization in the stomach",
"Objectives : Studies have confirmed the safety of oropharyngeal administration of colostrum in very low birth weight infants . However , the effect of oropharyngeal administration of colostrum on immune system is inconclusive . This study aims to evaluate the effect of oropharyngeal administration of colostrum on secretory immunoglobulin A and lactoferrin in very low birth weight infants . Design : R and omized controlled trial . Setting : Forty-bedded neonatal ICU in a university children ’s hospital in the People ’s Republic of China . Patients : Very low birth weight infants were allocated to the study group ( n = 32 ) and control group ( n = 32 ) . Intervention : The intervention was oropharyngeal administration of 0.2 mL of their mother ’s colostrum every 4 hours for 7 days . The control group received saline solution . Measurements and Main Results : Secretory immunoglobulin A and lactoferrin in urine and saliva were measured within 24 hours of life ( baseline ) and at 7 and 21 days . Primary outcomes were changes of secretory immunoglobulin A and lactoferrin in urine and saliva between baseline and at 7 and 21 days . Infant ’s clinical data were also collected during hospitalization . Change from baseline in lactoferrin in saliva at 7 days ( 5.18 ± 7.07 vs –1.74 ± 4.67 µg/mL ; p of lactoferrin in urine and also no differences of secretory immunoglobulin A in urine and saliva . There were also no differences between days to full enteral feeding , occurrence rate of clinical sepsis , proven sepsis , and necrotizing enterocolitis . Conclusions : Oropharyngeal administration of colostrum can increases the level of lactoferrin in saliva in very low birth weight infants . No effect could be documented of secretory immunoglobulin A and lactoferrin in urine . Larger trials are needed to better describe the benefit of oropharyngeal administration of colostrum , if any , in very low birth weight infants",
"Objective : To study the incidence of sepsis and neonatal intensive care unit ( NICU ) costs as a function of the human milk ( HM ) dose received during the first 28 days post birth for very low birth weight ( VLBW ) infants . Study design : Prospect i ve cohort study of 175 VLBW infants . The average daily dose of HM ( ADDHM ) was calculated from daily nutritional data for the first 28 days post birth ( ADDHM-Days 1–28 ) . Other covariates associated with sepsis were used to create a propensity score , combining multiple risk factors into a single metric . Result : The mean gestational age and birth weight were 28.1±2.4 weeks and 1087±252 g , respectively . The mean ADDHM-Days 1–28 was 54±39 ml kg−1 day−1 ( range 0–135 ) . Binary logistic regression analysis controlling for propensity score revealed that increasing ADDHM-Days 1–28 was associated with lower odds of sepsis ( odds ratio 0.981 , 95 % confidence interval 0.967–0.995 , P=0.008 ) . Increasing ADDHM-Days 1–28 was associated with significantly lower NICU costs . Conclusion : A dose – response relationship was demonstrated between ADDHM-Days 1–28 and a reduction in the odds of sepsis and associated NICU costs after controlling for propensity score . For every HM dose increase of 10 ml kg−1 day−1 , the odds of sepsis decreased by 19 % . NICU costs were lowest in the VLBW infants who received the highest ADDHM-Days 1–28",
"OBJECTIVE : To determine the immunologic effects of oropharyngeal colostrum administration in extremely premature infants . METHODS : We conducted a double-blind , r and omized , placebo-controlled trial involving 48 preterm infants born before 28 weeks ’ gestation . Subjects received 0.2 mL of their mother ’s colostrum or sterile water via oropharyngeal route every 3 hours for 3 days beginning at 48 to 96 hours of life . To measure concentrations of secretory immunoglobulin A , lactoferrin , and several immune substances , urine and saliva were obtained during the first 24 hours of life and at 8 and 15 days . Clinical data during hospitalization were collected . RESULTS : Urinary levels of secretory immunoglobulin A at 1 week ( 71.4 vs 26.5 ng/g creatinine , P = .04 ) and 2 weeks ( 233.8 vs 48.3 ng/g creatinine , P = .006 ) , and lactoferrin at 1 week ( 3.5 vs 0.9 μg/g creatinine , P = .01 ) were significantly higher in colostrum group . Urine interleukin-1β level was significantly lower in colostrum group at 2 weeks ( 55.3 vs 91.8 μg/g creatinine , P = .01 ) . Salivary transforming growth factor-β1 ( 39.2 vs 69.7 μg/mL , P = .03 ) and interleukin-8 ( 1.2 vs 4.9 ng/mL , P = .04 ) were significantly lower at 2 weeks in colostrum group . A significant reduction in the incidence of clinical sepsis was noted in colostrum group ( 50 % vs 92 % , P = .003 ) . CONCLUSIONS : This study suggests that oropharyngeal administration of colostrum may decrease clinical sepsis , inhibit secretion of pro-inflammatory cytokines , and increase levels of circulating immune-protective factors in extremely premature infants . Larger studies to confirm these findings are warranted",
"OBJECTIVES To determine the rates , risk factors , and outcomes of ventilator-associated pneumonia in pediatric intensive care unit ( PICU ) patients . METHODS A prospect i ve cohort study was conducted at the St Louis Children 's Hospital PICU on all patients who were admitted to the PICU from September 1 , 1999 , to May 31 , 2000 , except those who died within 24 hours , were > or = 18 years of age , or were neonatal intensive care unit patients on extracorporeal membrane oxygenation . The primary outcome measured was the development of ventilator-associated pneumonia . Secondary outcomes were death and hospital and PICU length of stay . Multiple logistic regression analysis was performed to determine independent predictors for ventilator-associated pneumonia . RESULTS There were 34 episodes of ventilator-associated pneumonia in 30 patients of 911 admissions ( 3.3 % ) and 595 ( 5.1 % ) mechanically ventilated patients . The mean ventilator-associated pneumonia rate was 11.6/1000 ventilator days . By logistic regression analysis , genetic syndrome ( odds ratio [ OR ] : 2.37 ; 95 % confidence interval [ CI ] : 1.01 - 5.46 ) , reintubation ( OR : 2.71 ; 95 % CI : 1.18 - 6.21 ) , and transport out of the PICU ( OR : 8.90 ; 95 % CI : 3.82 - 20.74 ) independently predicted ventilator-associated pneumonia . CONCLUSIONS Ventilator-associated pneumonia occurs at significant rates among mechanically ventilated PICU patients and is associated with processes of care . Additional studies are necessary to develop interventions to prevent ventilator-associated pneumonia",
"OBJECTIVES To characterize ventilator-associated pneumonia ( VAP ) in our pediatric intensive care unit ( PICU ) , implement an evidence -based pediatric VAP prevention bundle , and reduce VAP rates . STUDY DESIGN The setting is a 25-bed PICU in a 475-bed free-st and ing pediatric academic medical center . VAP was diagnosed according to Centers for Disease Control and National Nosocomial Infections Surveillance System definitions . A pediatric VAP prevention bundle was established and implemented . Baseline VAP rates were compared with implementation and post-bundle-implementation periods . RESULTS VAP is significantly associated with increased PICU length of stay , mechanical ventilator days , and mortality rates ( length of stay VAP 19.5+/-15.0 vs non-VAP 7.5+/-9.2 , P mortality VAP 19.1 % vs non-VAP 7.2 % , P= .01 ) . The VAP rate was reduced from 5.6 ( baseline ) to 0.3 infections per 1000 ventilator days after bundle implementation ; P Subglottic/tracheal stenosis , trauma , and tracheostomy are significantly associated with VAP . CONCLUSIONS PICU VAP is associated with increased morbidity and mortality rates . A multidisciplinary improvement team can implement a sustainable pediatric-specific VAP prevention bundle , result ing in VAP rate reduction",
"Aim Oropharyngeal administration of colostrum ( OAC ) has been proposed to provide mother 's early milk to very low‐birth‐weight ( VLBW ) infants in the first few days of life . The aim of this study was to test the hypothesis that OAC would increase salivary secretory IgA ( SsIgA ) . Patients and Methods Overall , 30 VLBW infants r and omized to receive OAC or sterile water had salivary sampling for SsIgA on the day of life ( DOL ) 2 , 7 , and 14 . The incidence of late‐onset sepsis ( LOS ) and necrotizing enterocolitis ( NEC ) was determined prospect ively . Within and between‐group comparisons were made by paired and independent sample s t ‐tests . Results Baseline characteristics were similar between groups . SsIgA was higher in OAC versus the control group ( p no difference in LOS or NEC . Conclusion OAC increased SsIgA at DOL 7 . A large , multicenter trial is needed to determine if OAC decreases LOS or NEC in VLBW infants",
"The premature infant suffers from immaturity of all organ systems , one of them being the gastrointestinal tract . When the infant is born , the immature gastrointestinal tract is exposed to milk and simultaneously colonized by high densities of bacteria . The combination of milk , microbiota and an immature gut , leaves the infant vulnerable to developing the dreaded intestinal emergency necrotizing enterocolitis ( NEC ) . NEC is often very aggressive and no cure exists , which means that prevention is an utmost important topic to research ers , physicians , parents - and infants . Despite immense research during the last decades , no specific test to determine if an infant suffers from NEC exists . Most neonatal units use Bell 's staging criteria , which are based on clinical and radiographic findings , as a diagnostic tool ; however the diagnosis given according to Bell 's stages has not been vali date d. In study I , we aim ed to determine the validity of the NEC diagnosis given at discharge . An expert panel consisting of a neonatologist , a paediatric surgeon and a paediatric radiologist served as the golden st and ard . We found that the diagnosis given at discharge had a poor validity which significantly affected the reported incidence of NEC in the neonatal department at Rigshospitalet , Denmark . The validity of the NEC diagnosis was worse than the validity of most other paediatric diagnoses that had been investigated . In studies II and III , we aim ed to explore possible means of NEC prevention . The role of nutrition in NEC development is well established with mother 's milk as the best option to avoid NEC in the preterm infant . Maternal milk is , however , most often not available in sufficient amounts during the first days of life , and preterm infant formula or human donor milk is used in its absence . Studies in preterm piglets showed that bovine colostrum equally to human donor milk protected against NEC compared to infant formula . Furthermore , bovine colostrum was superior to human donor milk in stimulating gut immunity and digestive functions . Hence , in study II we aim ed to design a pilot study of bovine colostrum used as a supplement to maternal milk in the first days of life and to determine if the study was feasible . In the paper , we present the protocol and the results of the first two phases of the Precolos study in which 12 infants were included and received pasteurized , spray-dried and reconstituted bovine colostrum during the first days of life as the first infants in the world . We found that the infants tolerated bovine colostrum without clinical adverse effects , but we also observed a transient hypertyrosinemia on day seven of life in five infants . The results were evaluated by a safety management board which encouraged us to continue the pilot study with the last phase , which was a r and omized controlled trial of 20 + 20 infants comparing supplementation with bovine colostrum to supplementation with st and ard nutrition . The r and omized trial has just finished recruitment . At last , we wanted to shed light on a possible microbiological angle of NEC prevention . Dysbiosis and bacterial translocation are believed to play a crucial role in the development of NEC as intestinal pneumatosis , which occurs when bacteria produce gas inside the intestinal wall , is a pathognomonic radiographic finding . In a quality improvement study from the US published in 2014 , NEC incidence was significantly reduced after the implementation of several quality improvement interventions . St and ardized weekly exchange of nasogastric feeding tubes was suggested as one of the potential NEC-reducing interventions . In the neonatal unit at Rigshospitalet , Denmark , preterm infants are fed 8 - 12 times daily through a resident nasogastric feeding tube which is exposed to body temperature , contains milk residuals from the last meal and is h and led by both parents and personnel . Since bacterial pollution of milk given through the nasogastric feeding tube might be NEC-inducing , we aim ed in study III to determine the bacterial load given to the infants when feeding them through a tube . We collected 92 used nasogastric feeding tubes and flushed them with one ml saline each to imitate a meal given through them . Eighty-nine percent of the tubes contaminated the meals with more than 1000 colony-forming units of bacteria and fifty-five percent contaminated the meals with the possible pathogens Enterobacteriaceae or Staphylococcus aureus . The concentration of bacteria in the saline flushed through the tubes was as high as 109 colony-forming units per ml ; however , neither the risk of contamination nor the concentration of bacteria in the flush was associated with the duration of use . Implementation of st and ardized weekly exchange of feeding tubes would therefore not prevent the contamination of meals . In conclusion , the studies included in this thesis serve as a base for future studies investigating the prevention of NEC . We found a poor validity of the NEC diagnosis given at discharge . This should be kept in mind when conducting epidemiological studies of NEC and especially when conducting interventional trials with NEC as an outcome . If the findings of the r and omized part of the Precolos study indicate a positive effect of bovine colostrum and do not give rise to concerns regarding feasibility , safety or tolerability , a large-scale r and omized controlled study with NEC as the primary outcome will be planned . Based on the high concentrations of bacteria found in the nasogastric feeding tubes , a r and omized controlled trial investigating whether the frequency of feeding tube exchange affects the early colonization has been commenced in the neonatal department at Rigshospitalet . Hopefully , the results of these studies will bring us closer to preventing NEC in the future",
"OBJECTIVE The purpose of this study was to evaluate the effects of oropharyngeal colostrum administration in the incidence of late-onset clinical and proven sepsis and in concentrations of immunoglobulin A ( IgA ) in very-low-birth-weight ( VLBW ) infants . METHODS We conducted a double-blinded , r and omized , placebo-controlled trial and assigned 113 VLBW infants to receive 0.2 mL of maternal colostrum or sterile water ( placebo ) via oropharyngeal route every 2 hours for 48 hours , beginning in the first 48 to 72 hours of life . Neonates of both groups were fed breast milk from the first 3 days of life until a volume of at least 100 mL · kg · day . IgA was measured in serum and urine before and after treatment . Clinical data during hospitalization were collected . RESULTS We found no statistically significant differences between colostrum and placebo groups in the incidence of late-onset clinical sepsis ( odds ratio 0.7602 ; CI 95 % 0.3 - 1.6 ) and proven sepsis ( odds ratio 0.7028 ; CI 95 % 0.3 - 1.6 ) . The measurement of IgA was similar in serum before ( P value 0.87 ) and after treatment ( P value 0.26 day 4 and 0.77 day 18 ) . No differences were also observed in IgA in urine before ( P value 0.8 ) and after treatment ( P value 0.73 day 4 and 0.52 ) . CONCLUSIONS This study could not confirm the hypothesis that oropharyngeal administration of maternal colostrum to VLBW could reduce the incidence of late-onset sepsis and increase the levels of IgA. We believe that this finding can be justified by the practice of feeding VLBW infants exclusively with breast milk in the first days of life and reinforces the prior knowledge of the importance of early nutrition , especially , with human milk . It also suggests that oropharyngeal administration of colostrum should be reserved for neonates who can not be fed in first few days of life",
"BACKGROUND Oropharyngeal administration of mother 's colostrum in early days has an immunoprotective effect in preterm infants . OBJECTIVES Our aim was to study the effect of oropharyngeal administration of mother 's milk ( OPAMM ) on decreasing the incidence of nosocomial sepsis . METHODS In a pilot prospect i ve r and omized study on preterm ( , we compared OPAMM practice ( applying 0.2 mL of mother 's colostrum or milk prior to gavage feeding until full oral feeding is reached ) with regular gavage feeding . The primary outcome was incidence of culture-proven nosocomial sepsis . Secondary outcomes included bacterial colonization of the gastrointestinal tract , feeding intolerance , time to reach full feeding , incidence of necrotizing enterocolitis , ventilator-associated pneumonia , duration of respiratory support , incidence of bronchopulmonary dysplasia ( BPD ) , length of hospital stay , and neonatal mortality . RESULTS The outcomes of 200 neonates ( 100 in each group ) were analyzed . OPAMM practice did not significantly reduce the incidence of culture proven nosocomial sepsis ( 8 % vs 13 % , P = 0.35 ) . Infants in the OPAMM group had a significantly lower growth of Klebsiella species in the oropharyngeal pouch , borderline lower incidence of ventilator-associated pneumonia , shorter duration of oxygen therapy , less episodes of feeding intolerance , reached full feeding earlier , and had a shorter length of hospital stay . OPAMM practice did not affect the incidence of necrotizing enterocolitis , BPD , or neonatal mortality . CONCLUSION OPAMM prior to gavage feeding does not reduce the incidence of nosocomial sepsis but had beneficial effects on early achievement of feeding , and early hospital discharge in preterm very low-birth-weight infants",
"AIM To study the role of oropharyngeal administration of colostrum ( OAC ) in very-low-birth-weight infants for reducing necrotizing enterocolitis ( NEC ) . STUDY DESIGN In this r and omized controlled trial , 117 infants were enrolled , 59 were r and omized to OAC group and 58 to routine care group . Infants with birth weight ≤ 1,250 g and /or gestational age ≤ 30 weeks were enrolled . Infants in OAC group received maternal colostrum ( 0.2 mL ) , 0.1 mL on either side , after 24 hours of postnatal life and were given every 2 hour for the next 72 hours irrespective of the enteral feeding status of the neonate . The primary outcome of the study was the incidence of NEC ( stage 2 or 3 ) . RESULTS Baseline characteristics were comparable between the two groups . There was no significant reduction in the incidence of NEC in OAC group ( 0 [ 0 % ] vs. 3 [ 7.1 % ] ; p = 0.11 ) . There was significant reduction of 7 days of hospital stay in OAC group ( 34.2 ± 5.7 vs. 41.5 ± 6.7 days ; p = 0.04).The incidence of early-onset sepsis , late-onset sepsis , blood culture positive sepsis , and ventilator-associated pneumonia were comparable between the two groups . CONCLUSION OAC is safe and reduces the duration of hospital stay",
"OBJECTIVE : People with multiple and persistent mental and physical health problems have high rates of transition failures when transferring from a hospital level of care to home . The transitional care model ( TCM ) is evidence -based and demonstrated to improve posthospital outcomes for elderly with physical health conditions , but it has not been studied in the population with serious mental illness . METHOD : Using a r and omized controlled design , 40 in patients from two general hospital psychiatric units were recruited and r and omly assigned to an intervention group ( n = 20 ) that received the TCM intervention that was delivered by a psychiatric nurse practitioner for 90 days posthospitalization , or a control group ( n = 20 ) that received usual care . Outcomes were as follows : service utilization , health-related quality of life , and continuity of care . RESULTS : The intervention group showed higher medical and psychiatric rehospitalization than the control group ( p = .054 ) . Emergency room use was lower for intervention group but not statistically significant . Continuity of care with primary care appointments were significantly higher for the intervention group ( p = .023 ) . The intervention group ’s general health improved but was not statistically significant compared with controls . CONCLUSIONS : A transitional care intervention is recommended ; however , the model needs to be modified from a single nurse to a multidisciplinary team with expertise from a psychiatric nurse practitioner , a social worker , and a peer support specialist . A team approach can best manage the complex physical/mental health conditions and complicated social needs of the population with serious mental illness"
] | 41162fd6-06ff-11f0-808a-c43d1ab1c353 |
Purpose To up date guideline recommendations on the role of bone-modifying agents in multiple myeloma . Methods An up date panel conducted a targeted systematic literature review by search ing PubMed and the Cochrane Library for r and omized controlled trials , systematic review s , meta-analyses , clinical practice guidelines , and observational studies . Results Thirty-five relevant studies were identified , and up date d evidence supports the current recommendations . Recommendations For patients with active symptomatic multiple myeloma that requires systemic therapy with or without evidence of lytic destruction of bone or compression fracture of the spine from osteopenia on plain radiograph(s ) or other imaging studies , intravenous administration of pamidronate 90 mg over at least 2 hours or zoledronic acid 4 mg over at least 15 minutes every 3 to 4 weeks is recommended . Denosumab has shown to be noninferior to zoledronic acid for the prevention of skeletal-related events and provides an alternative . Fewer adverse events related to renal toxicity have been noted with denosumab compared with zoledronic acid and may be preferred in this setting . The up date panel recommends that clinicians consider reducing the initial pamidronate dose in patients with preexisting renal impairment . Zoledronic acid has not been studied in patients with severe renal impairment and is not recommended in this setting . The up date panel suggests that bone-modifying treatment continue for up to 2 years . Less frequent dosing has been evaluated and should be considered in patients with responsive or stable disease . Continuous use is at the discretion of the treating physician and the risk of ongoing skeletal morbidity . Retreatment should be initiated at the time of disease relapse . The up date panel discusses measures regarding osteonecrosis of the jaw . Additional information is available at www.asco.org/hematologic-malignancies- guidelines and www.asco.org/ guidelines wiki | [
"Purpose : Patients with monoclonal gammopathy of undetermined significance ( MGUS ) have increased rates of bone resorption , osteopenia , osteoporosis , and risk of fractures . This study was undertaken to determine the efficacy and safety of zoledronic acid for patients with MGUS and enhanced bone loss . Experimental Design : In this phase II open-label study , 54 patients with MGUS and osteopenia or osteoporosis were administered zoledronic acid 4 mg i.v . at 0 , 6 , and 12 months . The primary efficacy end point was bone mineral density , assessed using a dual-energy X-ray absorptiometry scan in the lumbar (L)-spine done at screening and at 13 months ( 1 month after the final zoledronic acid infusion ) . Results : At study end for all patients ( N = 54 ) , L-spine T-scores improved by a median of + 0.27 ( range , −0.38 to + 3.91 ) , corresponding to a median increase in bone mineral density of + 15.0 % ( range , −18.0 % to + 1,140.0 % ; P improved by a median of + 0.10 ( range , −2.40 to + 2.03 ) , corresponding to a median increase of + 6.0 % ( range , −350.0 % to + 165.0 % ) . During the study , no new fractures , osteonecrosis of the jaw , or significant renal adverse events were reported . Conclusions : Zoledronic acid administered i.v . at a dosage of 4 mg every 6 months for three doses total was well-tolerated and substantially improved bone mineral density for patients with MGUS and bone loss . Zoledronic acid may be effective for the prevention of new fractures in this high-risk population",
"The Medical Research Council Myeloma IX Trial ( IS RCT NG8454111 ) examined traditional and thalidomide-based induction and maintenance regimens and IV zoledronic acid ( ZOL ) and oral clodronate ( CLO ) in 1960 patients with newly diagnosed multiple myeloma . Overall survival ( OS ) and skeletal-related event ( SRE ) data have been reported for the overall trial population . The present analysis investigated optimal therapy regimens for different patient population s in Myeloma IX . Patients were assigned to intensive or nonintensive treatment pathways and r and omized to induction cyclophosphamide , vincristine , doxorubicin , and dexamethasone ( CVAD ) versus cyclophosphamide , thalidomide , and dexamethasone ( CTD ; intensive ) or melphalan and prednisolone versus attenuated oral CTD ( CTDa ; nonintensive ) . Patients were also r and omized to ZOL or CLO . In the nonintensive pathway , CTDa produced better responses and lower SRE rates than melphalan and prednisolone . ZOL improved OS compared with CLO independently of sex , stage , or myeloma subtype , most profoundly in patients with baseline bone disease or other SREs . In patients treated for ≥ 2 years , ZOL improved OS compared with CLO from r and omization ( median not reached for either ; P = .02 ) and also from first on- study disease progression ( median , 34 months for ZOL vs 27 months for CLO ; P = .03 ) . Thalidomide-containing regimens had better efficacy than traditional regimens , and ZOL demonstrated greater benefits than CLO",
"A prospect i ve , multicenter , r and omized trial comparing pamidronate administration ( 60–90 mg once a month for 1 year ) versus simple observation in 177 patients with asymptomatic myeloma was performed to explore whether the administration of this drug reduces the rate of and /or the time to progression to overt , symptomatic disease . No relevant side effects were recorded in pamidronate-treated patients . With a minimum follow-up of 5 years for live patients , there were 56/89 ( 62.9 % ) progressions in the pamidronate-treated group and 55/88 ( 62.5 % ) within the controls ( p = NS ) . Median time to progression was 46 and 48 months , respectively ( p = NS ) . Overall survival was also similar between the two groups . Skeletal-related events at the time of progression were observed in 40/55 ( 72.7 % ) controls , but only in 22/56 ( 39.2 % ) pamidronate-treated patients ( p = 0.009 ) . In conclusion , the administration of pamidronate in asymptomatic myeloma , while reducing bone involvement at progression , did not decrease the risk of transformation and the time to progression into overt myeloma",
"Background Cases of impaired renal function have been reported in patients who had been treated with both zoledronic acid and thalidomide for myeloma . Hence , we conducted a safety study of zoledronic acid and thalidomide in myeloma patients participating in a trial of maintenance therapy . Methods Twenty-four patients who were enrolled in a large r and omized trial of thalidomide vs no thalidomide maintenance therapy for myeloma , in which all patients also received zoledronic acid , were recruited to a pharmacokinetic and renal safety sub- study , and followed for up to 16 months . Results No significant differences by Wilcoxon rank-sum statistic were found in zoledronic acid pharmacokinetics or renal safety for up to 16 months in patients r and omized to thalidomide or not . Conclusion In myeloma patients receiving maintenance therapy , the combination of zoledronic acid and thalidomide appears to confer no additional renal safety risks over zoledronic acid alone",
"We prospect ively evaluated the effect of bortezomib , thalidomide and dexamethasone ( VTD ) consolidation on bone metabolism of 42 myeloma patients who underwent an autologous stem cell transplantation ( ASCT ) . VTD started on day 100 post ASCT ; patients received four cycles of VTD ( first block ) , were followed without treatment for 100 days and then received another four VTD cycles ( second block ) . During this 12-month period , bisphosphonates were not administered . Best response included stringent complete remission ( sCR ) in 15 ( 35.7 % ) patients , complete response ( CR ) in 13 ( 30.9 % ) , vgPR in 7 ( 16.6 % ) , PR in 4 ( 9.5 % ) , while 3 ( 7.1 % ) patients developed a progressive disease ( PD ) . Importantly , 33.3 % and 47.6 % of patients improved their status of response after the first and second VTD block , respectively . VTD consolidation result ed in a significant reduction of circulating C-terminal cross-linking telopeptide of collagen type I ( CTX ) , soluble receptor activator of the nuclear factor-kappa B lig and ( sRANKL ) and osteocalcin ( OC ) , whereas bone-specific alkaline phosphatase ( bALP ) remained stable compared with pre-VTD values . During the study period , only one patient with a PD developed a skeletal-related event ( that is , radiation to bone ) . The median time to progression ( TTP ) after ASCT was 34 months and the median time of next treatment was 40 months . We conclude that VTD consolidation post ASCT reduces bone resorption and is associated with a very low incidence of skeletal-related events ( SREs ) despite the absence of bisphosphonates ; the later do not appear to be necessary in this context",
"In a phase 3 trial of denosumab vs zoledronic acid in patients ( n=1776 ) with bone metastases and solid tumors or multiple myeloma , denosumab was superior to zoledronic acid for the primary end point of prevention of skeletal-related events . There was no difference in overall survival between the two groups ; however , an ad hoc overall survival analysis in the multiple myeloma subset of patients ( n=180 ) favored zoledronic acid ( hazard ratio ( HR ) 2.26 ; 95 % confidence interval ( CI ) 1.13–4.50 ; P=0.014 ) . In the present analysis , we found imbalances between the groups with respect to baseline risk characteristics . HRs with two-sided 95 % CIs were estimated using the Cox model . After adjustment in a covariate analysis , the CI crossed unity ( HR 1.86 ; 95 % CI 0.90–3.84 ; P=0.0954 ) . Furthermore , we found a higher rate of early withdrawals for the reasons of lost to follow-up and withdrawal of consent in the zoledronic acid group ; after accounting for these , the HR was 1.31 ( 95 % CI 0.80–2.15 ; P=0.278 ) . In conclusion , the survival results in multiple myeloma patients in this trial were confounded and will eventually be resolved by an ongoing phase 3 trial",
"Summary Background Bisphosphonates reduce the risk of skeletal events in patients with malignant bone disease , and zoledronic acid has shown potential anticancer effects in pre clinical and clinical studies . We aim ed to establish whether bisphosphonates can affect clinical outcomes in patients with multiple myeloma . Methods Patients of age 18 years or older with newly diagnosed multiple myeloma were enrolled from 120 centres in the UK . Computer-generated r and omisation sequence was used to allocate patients equally , via an automated telephone service , to receive 4 mg zoledronic acid as an infusion every 3–4 weeks or 1600 mg oral clodronic acid daily . Patients also received intensive or non-intensive induction chemotherapy . No investigators , staff , or patients were masked to treatment allocation , and bisphosphonate and maintenance therapy continued at least until disease progression . The primary endpoints were overall survival , progression-free survival , and overall response rate . We assessed between-group differences with Cox proportional hazards models for progression-free survival and overall survival , and with logistic regression models for overall response rate . Analysis was by intention to treat . This trial is registered , number IS RCT N68454111 . Findings 1970 patients were enrolled between May , 2003 , and November , 2007 , of whom 1960 were eligible for intention-to-treat analysis : 981 in the zoledronic acid group ( 555 on intensive chemotherapy , 426 on non-intensive chemotherapy ) ; and 979 on clodronic acid ( 556 on intensive chemotherapy , 423 on non-intensive chemotherapy ) . The treatment cutoff was Oct 5 , 2009 , with patients receiving bisphosphonates for a median of 350 days ( IQR 137–632 ) before disease progression , with a median of 3·7 years ' follow-up ( IQR 2·9–4·7 ) . Zoledronic acid reduced mortality by 16 % ( 95 % CI 4–26 ) versus clodronic acid ( hazard ratio [ HR ] 0·84 , 95 % CI 0·74–0·96 ; p=0·0118 ) , and extended median overall survival by 5·5 months ( 50·0 months , IQR 21·0 to not reached vs 44·5 months , IQR 16·5 to not reached ; p=0·04 ) . Zoledronic acid also significantly improved progression-free survival by 12 % ( 95 % CI 2–20 ) versus clodronic acid ( HR 0·88 , 95 % CI 0·80–0·98 ; p=0·0179 ) , and increased median progression-free survival by 2·0 months ( 19·5 months , IQR 9·0–38·0 vs 17·5 months , IQR 8·5–34·0 ; p=0·07 ) . Rates of complete , very good partial , or partial response did not differ significantly between the zoledronic acid and clodronic acid groups for patients receiving intensive induction chemotherapy ( 432 patients [ 78 % ] vs 422 [ 76 % ] ; p=0·43 ) or non-intensive induction chemotherapy ( 215 [ 50 % ] vs 195 [ 46 % ] ; p=0·18 ) . Both bisphosphonates were generally well tolerated , with similar occurrence of acute renal failure and treatment-emergent serious adverse events , but zoledronic acid was associated with higher rates of confirmed osteonecrosis of the jaw ( 35 [ 4 % ] ) than was clodronic acid ( 3 [ acid , overall survival improved independently of prevention of skeletal-related events , showing that zoledronic acid has treatment benefits beyond bone health . These findings support immediate treatment with zoledronic acid in patients with newly diagnosed multiple myeloma , not only for prevention of skeletal-related events , but also for potential antimyeloma benefits . Funding Medical Research Council ( London , UK ) , with unrestricted educational grants from Novartis , Schering Health Care , Chugai , Pharmion , Celgene , and Ortho Biotech",
"PURPOSE The reported incidence of osteonecrosis of the jaw ( ONJ ) ranges from 0.94 % to 18.6 % . This cohort study aim ed to calculate the incidence of and identify the risk factors for ONJ in patients with cancer treated with intravenous zoledronate , ib and ronate , and pamidronate . PATIENTS AND METHODS Data analyzed included age , sex , smoking status , underlying disease , medical and dental history , bisphosphonates ( BP ) type , and doses administered . Relative risks , crude and adjusted odds ratios ( aORs ) , and cumulative hazard ratios for ONJ development were calculated . RESULTS We included 1,621 patients who received 29,006 intravenous doses of BP , given monthly . Crude ONJ incidence was 8.5 % , 3.1 % , and 4.9 % in patients with multiple myeloma , breast cancer , and prostate cancer , respectively . Patients with breast cancer demonstrated a reduced risk for ONJ development , which turned out to be nonsignificant after adjustment for other variables . Multivariate analysis demonstrated that use of dentures ( aOR = 2.02 ; 95 % CI , 1.03 to 3.96 ) , history of dental extraction ( aOR = 32.97 ; 95 % CI , 18.02 to 60.31 ) , having ever received zoledronate ( aOR = 28.09 ; 95 % CI , 5.74 to 137.43 ) , and each zoledronate dose ( aOR = 2.02 ; 95 % CI , 1.15 to 3.56 ) were associated with increased risk for ONJ development . Smoking , periodontitis , and root canal treatment did not increase risk for ONJ in patients receiving BP . CONCLUSION The conclusions of this study vali date d dental extraction s and use of dentures as risk factors for ONJ development . Ib and ronate and pamidronate at the dosages and frequency used in this study seem to exhibit a safer drug profile concerning ONJ complication ; however , r and omized controlled trials are needed to vali date these results . Before initiation of a bisphosphonate , patients should have a comprehensive dental examination . Patients with a challenging dental situation should have dental care attended to before initiation of these drugs",
"RANKL is a key mediator of osteoclast differentiation , activation , and survival . Pre clinical data suggest that aberrant production and activation of osteoclasts may influence proliferation of multiple myeloma ( MM ) cells in the bone marrow . Reports have also shown that inhibiting RANKL may have a direct effect on RANK‐expressing myeloma cells and a therapeutic role in treating the disease . In mouse myeloma models , inhibition of RANKL led to reduced serum paraprotein levels and tumor burden . Based on this hypothesis , this proof‐of‐concept , single‐arm study investigated whether RANKL inhibition with denosumab could reduce serum M‐protein levels in relapsed or plateau‐phase myeloma subjects . All subjects received denosumab monthly , with loading doses on days 8 and 15 of month one , until disease progression or subject discontinuation . Results of this ongoing study demonstrated that no subjects in either cohort met the protocol ‐defined objective response criteria of complete response ( CR ) or partial response ( PR ) , but that denosumab effectively inhibited the RANKL pathway regardless of previous exposure to bisphosphonates , as evidence d by suppressed levels of the bone turnover marker , serum C‐terminal telopeptide of type 1 collagen ( sCTx ) . Eleven ( 21 % ) subjects who relapsed within 3 months before study entry maintained stable disease for up to 16.5 months . Nineteen ( 46 % ) subjects with plateau‐phase myeloma maintained stable disease for up to 18.3 months . The adverse event ( AE ) profile for denosumab and its dosing schedule in these population s was consistent with that for advanced cancer patients receiving systemic therapy . Additional controlled clinical studies of denosumab in subjects with both relapsed and plateau‐phase MM are warranted . Am . J. Hematol . 2009 . © 2009 Wiley‐Liss ,",
"This study analyzed the anti-myeloma effect of zoledronic acid monotherapy by investigating patients at the time of asymptomatic biochemical relapse . One hundred patients were r and omized to receive either zoledronic acid ( 4 mg iv/4 weeks , 12 doses ) ( n=51 ) or not ( n=49 ) . Experimental and control groups were well balanced for disease and prognostic features . Zoledronic acid did not show an antitumor effect according to changes in M-component . However , there were fewer symptomatic progressions in the experimental group than in the control group ( 34 versus 41 , respectively ; P=0.05 ) result ing in a median time to symptoms of 16 versus 10 months ( P=0.161 ) . The median time to next therapy was also slightly longer for the treated group than the untreated , control group ( 13.4 versus 10.1 months ) , although the difference was not statistically significant ( P=0.360 ) . The pattern of relapses was different for treated versus control patients : progressive bone disease ( 8 versus 20 ) , anemia ( 24 versus 18 ) , renal dysfunction ( 1 versus 2 ) , and plasmacytomas ( 1 versus 1 , respectively ) . This concurred with fewer skeletal-related events in the treated group than in the control group ( 2 versus 14 ) , with a projected 4-year event proportion of 6 % versus 40 % ( P zoledronic acid monotherapy does not show an antitumor effect on biochemical relapses in multiple myeloma , but does reduce the risk of progression with symptomatic bone disease and skeletal complications . This trial was registered in the Clinical Trials.gov data base with code",
"BACKGROUND Compared with placebo , prophylactic treatment with bisphosphonates reduces risk of skeletal events in patients with multiple myeloma . However , because of toxicity associated with long-term bisphosphonate treatment , establishing the lowest effective dose is important . This study compared the effect of two doses of pamidronate on health-related quality of life and skeletal morbidity in patients with newly diagnosed multiple myeloma . METHODS This double-blind , r and omised , phase 3 trial was undertaken at 37 clinics in Denmark , Norway , and Sweden . Patients with multiple myeloma who were starting antimyeloma treatment were r and omly assigned in a 1:1 ratio to receive one of two doses of pamidronate ( 30 mg or 90 mg ) given by intravenous infusion once a month for at least 3 years . R and omisation was done by use of a central , computerised minimisation system . Primary outcome was physical function after 12 months estimated by the European Organisation for Research and Treatment of Cancer ( EORTC ) QLQ-C30 question naire ( scale 0 - 100 ) . All patients who returned question naires at 12 months and were still on study treatment were included in the analysis of the primary endpoint . This study is registered with Clinical Trials.gov , number NCT00376883 . FINDINGS From January , 2001 , until August , 2005 , 504 patients were r and omly assigned to pamidronate 30 mg or 90 mg ( 252 in each group ) . 157 patients in the 90 mg group and 156 in the 30 mg group were included in the primary analysis . Mean physical function at 12 months was 66 points ( 95 % CI 62·9 - 70·0 ) in the 90 mg group and 68 points ( 64·6 - 71·4 ) in the 30 mg group ( 95 % CI of difference -6·6 to 3·3 ; p=0·52 ) . Median time to first skeletal-related event in patients who had such an event was 9·2 months ( 8·1 - 10·7 ) in the 90 mg group and 10·2 months ( 7·3 - 14·0 ) in the 30 mg group ( p=0·63 ) . In a retrospective analysis , eight patients in the pamidronate 90 mg group developed osteonecrosis of the jaw compared with two patients in the 30 mg group . INTERPRETATION Monthly infusion of pamidronate 30 mg should be the recommended dose for prevention of bone disease in patients with multiple myeloma . FUNDING Nordic Cancer Union and Novartis Healthcare",
"PURPOSE To evaluate the natural history of bisphosphonate-related osteonecrosis of the jaw ( ONJ ) in patients with multiple myeloma . PATIENTS AND METHODS Ninety-seven patients with myeloma from the United States ( n = 37 ) and Greece ( n = 60 ) were observed prospect ively for a minimum 3.2 years after ONJ . Patients characteristics were similar with regard to age , bisphosphonate use , and myeloma therapy , except more autologous transplantations were performed on patients in the United States than in Greece ( 73 % v 28 % ; P ONJ resolved in 60 patients ( 62 % ) , resolved and recurred in 12 patients ( 12 % ) , and did not heal in 25 patients ( 26 % ) . Dental procedures preceded ONJ in 46 patients ( 47 % ) and were more common in those with single episodes ( 35 of 60 , 58 % ) than recurrent or nonhealing ( 11 of 37 , 30 % ; P = .007 ) . Recurrent ONJ followed reinitiation of bisphosphonates in six of 12 patients . Greek patients had more bone pain than United States patients ( 60 % v 30 % , P = .001 ) and were less likely to restart bisphosphonates ( 5 % v 35 % , P Myeloma relapses were more common in patients with recurrent/nonhealing than single-episode ONJ ( 84 % v 62 % ; P = .02 ) . Median overall survival from myeloma diagnosis was 10.8 years ( 95 % CI ; 9.3 years to not reached ) and did not differ between patients with single , recurrent , and nonhealing ONJ ( P = .2 ) . CONCLUSION ONJ healed in 75 % of patients . Patients with spontaneous ONJ have a higher risk of nonhealing and recurrence . Reinitiating bisphosphonates after healing of ONJ is a reasonable option in patients experiencing relapse who are at risk of skeletal complications . Further studies of the pathogenesis and healing of ONJ are needed",
"OBJECTIVES Bone disease is a key presenting feature of myeloma . This post hoc analysis of the phase III VISTA trial of bortezomib plus melphalan-prednisone ( VMP ) vs. MP in previously untreated myeloma patients assessed clinical bone disease events and changes in alkaline phosphatase ( ALP ) , a marker for osteoblast activation , and serum Dickkopf-1 ( DKK-1 ) , an inhibitor of osteoblast differentiation , during treatment . METHODS Patients received nine 6-wk cycles of VMP ( bortezomib 1.3 mg/m(2 ) , days 1 , 4 , 8 , 11 , 22 , 25 , 29 , 32 , cycles 1 - 4 , days 1 , 8 , 22 , 29 , cycles 5 - 9 , plus melphalan 9mg/m(2 ) and prednisone 60mg/m(2 ) , days 1 - 4 , cycles 1 - 9 ; N=344 ) or MP alone ( N=338 ) . RESULTS Rates of bisphosphonates use during treatment ( 73 % vs. 82 % ) , progression because of worsening bone disease ( 3 % vs. 11 % ) , and requirement for subsequent radiotherapy ( 3 % vs. 8 % ) were lower with VMP vs. MP . Median maximum ALP increase was significantly higher with VMP vs. MP overall ( 49.7 % vs. 30.3 % , P=0.029 ) , and higher by response group ( complete response [ CR ] : 68.7 % vs. 43.9 % ; partial response [ PR ] : 41.5 % vs. 31.2 % ) . Greater maximum ALP increase was strongly associated with achievement of CR ( P≤0.0001 ) and CR/PR ( P≤0.01 ) . Median DKK-1 decreased with VMP by 694.4pg/mL and increased with MP by 1273.3pg/mL from baseline to day 4 ( P=0.0069 ) . Available radiologic data revealed evidence of bone healing in 6/11 VMP-treated patients , who achieved best responses of three CR , one PR , and two stable disease . CONCLUSIONS These results suggest a positive effect of bortezomib on bone metabolism and potentially bone healing in myeloma",
"Bisphosphonates ( BPs ) are effective in the prevention and treatment of skeletal‐related events ( SREs ) in patients with symptomatic myeloma who are receiving chemotherapy . Recent data also suggest a possible antineoplastic activity of BPs . Few studies published to date have explored the role of BPs in patients with untreated , asymptomatic myeloma ( AM ) . No data are available on the efficacy of zoledronic acid in these patients",
"Bisphosphonates are recommended in patients with osteolytic lesions secondary to multiple myeloma . We report on the safety of bisphosphonate therapy with long‐term follow‐up in the Medical Research Council Myeloma IX study . Patients with newly diagnosed multiple myeloma were r and omised to zoledronic acid ( ZOL ; 4 mg intravenously every 21–28 d ) or clodronate ( CLO ; 1600 mg/d orally ) plus chemotherapy . Among 1960 patients ( 5·9‐year median follow‐up ) , both bisphosphonates were well tolerated . Acute renal failure events were similar between groups ( ZOL 5·2 % vs. CLO 5·8 % at 2 years ; incidence plateaued thereafter ) . The overall incidence of confirmed osteonecrosis of the jaw ( ONJ ) was low , but higher with ZOL ( ZOL 3·7 % vs. CLO 0·5 % ; P events were generally low grade and most occurred between 8 and 30 months ( median time to ONJ , 23·7 months ) . Among 10 patients with ONJ recovery data , four patients in the ZOL group completely recovered , two patients improved , and three patients experienced no improvement ; one CLO patient experienced no improvement . Dental surgery or trauma preceded ONJ in six ZOL patients . The incidence of renal adverse events was similar for ZOL and CLO . ONJ incidence remained low and was lower with CLO compared to ZOL . We have seen no further ONJ cases to date"
] | 41163012-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE To determine the efficacy and safety of sildenafil citrate in the treatment of male erectile dysfunction . DATA SOURCES The MEDLINE , HealthSTAR , Current Contents , and Cochrane Library data bases ( January 1 , 1995 , through December 31 , 2000 ) ; bibliographies of retrieved articles and review articles ; conference proceedings abstract s ; the Food and Drug Administration Web site ; and the manufacturer . STUDY SELECTION Trials were eligible if they included men with erectile dysfunction , compared sildenafil with control , were r and omized , were of at least 7 days ' duration , and assessed clinical ly relevant outcomes . DATA EXTRACTION Two review ers independently evaluated study quality and extracted data in a st and ardized fashion . DATA SYNTHESIS Twenty-seven trials ( 6659 men ) met the inclusion criteria . In results pooled from 14 parallel-group , flexible as-needed dosing trials , sildenafil was more likely than placebo to lead to successful sexual intercourse , with a higher percentage of successful intercourse attempts ( 57 % vs 21 % ; weighted mean difference , 33.7 ; 95 % confidence interval [ CI ] , 29.2 - 38.2 ; 2283 men ) and a greater percentage of men experiencing at least 1 intercourse success during treatment ( 83 % vs 45 % ; relative benefit increase , 1.8 ; 95 % CI , 1.7 - 1.9 ; 2205 men ) . In data pooled from 6 parallel-group , fixed-dose trials , efficacy appeared slightly greater at higher doses . Treatment response appeared to vary between patient subgroups , although relative to placebo , sildenafil significantly improved erectile function in all evaluated subgroups . In trials with parallel-group design and flexible dosing , men r and omized to receive sildenafil were less likely than those receiving placebo to drop out for any reason and no more likely to drop out due to an adverse event or laboratory abnormality . Specific adverse events with sildenafil included flushing ( 12 % ) , headache ( 11 % ) , dyspepsia ( 5 % ) , and visual disturbances ( 3 % ) ; all adverse events were significantly less likely to occur with placebo . Sildenafil was not significantly associated with serious cardiovascular events or death . CONCLUSIONS Sildenafil improves erectile function and is generally well tolerated . Treatment response seems to vary between patient subgroups , although sildenafil has greater efficacy than placebo in all evaluated subgroups | [
"PURPOSE Now that individuals with spina bifida live well into adulthood erectile dysfunction has become a recognized associated medical disorder . To our knowledge no study has dealt specifically with treatment of erectile dysfunction in men with spina bifida . Therefore , we conducted a prospect i ve , blinded , r and omized , placebo controlled , dose escalation , crossover study to determine the ability to treat erectile dysfunction in men with spina bifida with sildenafil citrate . MATERIAL S AND METHODS Erectile dysfunction was diagnosed in 15 men 19 to 35 years old with spina bifida who were assigned to take 4 sets of tablets , 5 tablets per set , in a r and om order . All patients took 25 and 50 mg . sildenafil and 2 identical looking sets of corresponding placebos 1 hour before planned sexual activity . Efficacy was assessed by the effect of treatment compared to baseline , that is before treatment , on rating of erections ( scored from 0 to 10 ) , duration of erections , frequency of erections based on response to question 1 ( scored from 0 to 5 ) of the International Index of Erectile Function and confidence to obtain an erection based on response to question 15 ( scored from 1 to 5 ) of the International Index of Erectile Function . RESULTS Improved erectile function was reported while on sildenafil by 12 ( 80 % ) men compared to baseline and placebos . There was a significant dose dependent improvement of erectile function with both 25 and 50 mg . sildenafil compared to baseline ( p mean erectile score increased by 50 % and 88 % , mean duration of erections increased by 192 % and 266 % , mean frequency of erections increased by 61 % and 96 % , and mean level of confidence increased by 33 % and 63 % , respectively . Furthermore , 50 mg . sildenafil provided greater improvement in all 4 parameters compared to 25 mg . The placebo results were not significantly different compared to baseline for any of the parameters . CONCLUSIONS Erectile dysfunction in patients with spina bifida is a medically treatable condition . Sildenafil is effective in this patient population and improves level of sexual confidence",
"Study design : This was a two-part pilot study in men with erectile dysfunction ( ED ) due to spinal cord injury ( SCI : cord level range T6-L5 ) . Part I was a r and omised , double-blind , two-way cross-over study comparing a single dose of sildenafil 50 mg or placebo . Part II was a r and omised , double-blind , parallel-group evaluation of sildenafil 50 mg or placebo , taken as required ( not more than once daily ) approximately 1 h prior to sexual activity , over a period of 28 days . Objectives : To assay the efficacy and safety of sildenafil 50 mg and placebo . Setting : Clinic- and home-based assessment s in the United Kingdom . Methods : A total of 27 subjects who were able to achieve at least a grade 2 erection ( hard , but not hard enough for penetration ) in response to penile vibratory stimulation ( PVS ) were recruited . In Part I , the reflexogenic response of the penis to PVS was evaluated in the clinic while in Part II , the response to treatment was assessed in the home ( global efficacy , question niare , diary ) . Results : In Part I , 17/26 ( 65 % ) subjects had erections of > 60 % rigidity at the penile base ( median duration 3.5 min ) after sildenafil compared with 2/26 ( 8 % ) ( median duration 0 min ) after placebo ( P=0.0003 ) . In Part II , 9/12 ( 75 % ) subjects on sildenafil and 1/14 ( 7 % ) subjects on placebo reported that the treatment had improved their erections ( P mean number of erections hard enough for penetration ( P=0.08 ) . The mean proportion of attempts at sexual intercourse that were successful was 30 and 15 % , respectively ( P=0.21 ) . Similarly , responses to the end-of-treatment question naire indicated that there were no significant differences between the groups with respect to the frequency of erections hard enough for sexual intercourse ( P=0.47 ) or that lasted as long as the subject would have liked ( P=0.11 ) . No subject discontinued sildenafil due to adverse events . Conclusion : Sildenafil is an effective , well-tolerated oral treatment for ED in SCI subjects . Sponsorship : This study was funded by Pfizer",
"The efficacy and safety of oral sildenafil , a potent inhibitor of phosphodiesterase type 5 , were evaluated in men with diabetes mellitus and erectile dysfunction ( ED ) . Twenty-one men ( aged 42 - 65 years ) were enrolled in a double-blind , placebo-controlled , three-way crossover study conducted in two parts . In part I , the effect of a single dose ( 25 mg or 50 mg ) of sildenafil or placebo on penile rigidity was assessed by penile plethysmography during visual sexual stimulation . In part II , daily diary records of erectile activity and a global efficacy question were used to evaluate once-daily dosing with 25 mg or 50 mg of sildenafil or placebo for 10 days . After a single 50 mg dose of sildenafil , the adjusted geometric mean duration ( min ) of penile rigidity > 60 % at the base of the penis during visual sexual stimulation was significantly increased ( 10.1 min ) compared with placebo ( 2.8 min ; p = 0.0053 ) . In part II , sildenafil significantly increased the number of erections considered sufficiently hard for vaginal penetration compared with placebo ( p = 0.0005 ) . Improved erections were reported by 50 % and 52 % of patients treated with 25 mg and 50 mg of sildenafil , respectively , compared with 10 % of those receiving placebo ( p values Adverse events were mostly mild or moderate in nature and included muscular pains , headache , and dyspepsia . Sildenafil is a well-tolerated and potentially efficacious oral treatment for ED in men with diabetes mellitus",
"PURPOSE We assessed patient preference , satisfaction and overall outcome of goal directed management of erectile dysfunction . MATERIAL S AND METHODS The results of goal directed therapy of impotence were assessed by an independent telephone survey of 377 consecutive men who had not received prior therapy and who were followed for a minimum of 2 years . RESULTS Patients preferred medical to surgical therapies despite significantly higher satisfaction rates achieved with surgery . Average number of treatment modalities chosen by each patient was 2 ( range 0 to 5 ) . Ultimately , only 40 % of the patients achieved a long-term satisfactory result with goal directed therapy . The remainder were not satisfied with the last treatment but chose no further therapy , were lost to followup or refused therapy from the outset . CONCLUSIONS Our results clearly demonstrate a patient preference for the least invasive forms of therapy . Patients avoid significantly more effective but also more invasive treatment options despite unsatisfactory results with less invasive methods . Future research efforts should be concentrated on the development of new medical therapies to enhance overall patient satisfaction",
"PURPOSE Goal oriented therapy for erectile dysfunction , based on a complete education of the couple , was offered to 460 patients . The short-term and long-term results of the first and second treatments selected were compared . MATERIAL S AND METHODS From September 1991 to March 1995 , 460 patients with erectile dysfunction were evaluated and treated prospect ively . The success of treatment , selected by the patient or couple , was defined as the ability to achieve and maintain good erections for successful coitus for at least 1 year after the start of therapy . Sexual satisfaction of the couple was required to confirm a successful outcome . RESULTS The preferred first line of treatment by 322 patients was pharmacotherapy , with intracavernous injections being the second most selected therapy ( 80 % success rate ) . However , there was a high long-term dropout rate for intracavernous injections . Approximately 70 % of the patients were lost to followup or refused further treatment . CONCLUSIONS Overall , this prospect i ve study showed that goal oriented therapy is initially highly successful . However , the long-term high dropout rate and dissatisfaction of the couple cast doubt about the efficacy of the present treatment options",
"OBJECTIVES To evaluate the efficacy , safety , and tolerability of oral sildenafil in Asian men with erectile dysfunction of various causes ( organic , psychogenic , or mixed ) and of more than 6 months ' duration . METHODS In this double-blind , parallel-group trial conducted at eight centers in Malaysia , the Philippines , and Singapore , 254 men , 26 to 78 years old , were r and omized to 12 weeks of sildenafil or placebo taken as needed 1 hour before anticipated sexual activity . Initially , the sildenafil ( n = 127 ) or matching placebo ( n = 127 ) dose was 50 mg but could be increased to 100 mg or decreased to 25 mg because of a lack of efficacy or intolerance , respectively . Efficacy was assessed by the 15- question International Index of Erectile Function , patients ' event logs of sexual activity , and a global efficacy question about erections . RESULTS The two primary efficacy variables relating to achievement and maintenance of an erection sufficient for sexual intercourse , as assessed by the mean scores for International Index of Erectile Function question 3 ( 4.22 versus 2.59 ) and question 4 ( 4.15 versus 2.41 ) , were both significantly higher with sildenafil than with placebo ( P International Index of Erectile Function domains of sexual function , the percentage of successful intercourse attempts , and the global efficacy assessment of erections revealed significantly greater treatment effects in favor of sildenafil ( P Treatment-related adverse events occurred in 22.8 % of patients who received sildenafil and in 10.2 % of those who received placebo . CONCLUSIONS Sildenafil is an effective and well-tolerated treatment for Asian men with erectile dysfunction of broad-spectrum etiology",
"BACKGROUND Sildenafil is a potent inhibitor of cyclic guanosine monophosphate hydrolysis [ corrected ] in the corpus cavernosum and therefore increases the penile response to sexual stimulation . We evaluated the efficacy and safety of sildenafil , administered as needed in two sequential double-blind studies of men with erectile dysfunction of organic , psychogenic , and mixed causes . METHODS In a 24-week dose-response study , 532 men were treated with oral sildenafil ( 25 , 50 , or 100 mg ) or placebo . In a 12-week , flexible dose-escalation study , 329 different men were treated with sildenafil or placebo , with dose escalation to 100 mg based on efficacy and tolerance . After this dose-escalation study , 225 of the 329 men entered a 32-week , open-label extension study . We assessed efficacy according to the International Index of Erectile Function , a patient log , and a global-efficacy question . RESULTS In the dose-response study , increasing doses of sildenafil were associated with improved erectile function ( P values for increases in scores for questions about achieving and maintaining erections were sildenafil , the mean score for the question about achieving erections was 100 percent higher after treatment than at base line ( 4.0 vs. 2.0 of a possible score of 5 ) . In the last four weeks of treatment in the dose-escalation study , 69 percent of all attempts at sexual intercourse were successful for the men receiving sildenafil , as compared with 22 percent for those receiving placebo ( P mean numbers of successful attempts per month were 5.9 for the men receiving sildenafil and 1.5 for those receiving placebo ( P Headache , flushing , and dyspepsia were the most common adverse effects in the dose-escalation study , occurring in 6 percent to 18 percent of the men . Ninety-two percent of the men completed the 32-week extension study . CONCLUSIONS Oral sildenafil is an effective , well-tolerated treatment for men with erectile dysfunction",
"OBJECTIVES To evaluate the efficacy , safety , and tolerability of sildenafil in men with broad-spectrum erectile dysfunction ( ED ) , with reference to age-matched healthy control subjects . METHODS One hundred eleven patients were enrolled in a r and omized , double-blind , placebo-controlled , parallel-group , 12-week , flexible-dose study . Efficacy assessment s included the International Index of Erectile Function ( IIEF ) , a global assessment question , and patient event log data . In a separate , nontreatment study , 109 control subjects also completed the IIEF . RESULTS Mean IIEF scores at baseline were significantly lower for patients with ED than for control subjects without a history of ED . After treatment , mean IIEF scores for patients receiving sildenafil approached values observed in control subjects and were significantly higher than mean scores for patients receiving placebo ( P Sildenafil was well tolerated , with no discontinuations because of adverse events . CONCLUSIONS The results indicate that sildenafil , an effective oral therapy for the treatment of broad-spectrum ED , is associated with a near normalization of patient erectile function",
"OBJECTIVES To determine the efficacy and safety of fixed-dose oral sildenafil in patients with erectile dysfunction ( ED ) of various etiologies . METHODS In a 12-week , double-blind , r and omized , placebo-controlled , fixed-dose study , 514 men ( mean age 56 years ) with ED were r and omized to receive 25 , 50 , or 100 mg of sildenafil or placebo . The primary etiology of ED was determined to be organic in 32 % of men , psychogenic in 25 % , or mixed in 43 % . Sildenafil or placebo was taken in the home setting approximately 1 hour before sexual activity , not more than once daily . Efficacy was determined by responses to question 3 ( ability to achieve an erection ) and question 4 ( ability to maintain an erection ) of the 15-item International Index of Erectile Function ( IIEF ) . Other measures of efficacy included the five sexual function domains of the IIEF , a global efficacy question , event log data , and a partner question naire . RESULTS Sildenafil significantly increased patients ' ability to achieve and maintain erections ( P efficacy increasing with increasing dose . Significant improvements were also observed in the IIEF domains for erectile function , orgasmic function , intercourse satisfaction , and overall sexual satisfaction ( P sildenafil improved their erections was significantly greater ( 67 % to 86 % ) than that with placebo treatment ( 24 % , P proportion of successful attempts at sexual intercourse also increased significantly with sildenafil treatment ( P tolerated at the three doses studied . CONCLUSIONS Oral sildenafil is an effective , well-tolerated treatment for ED of various etiologies",
"CONTEXT Erectile dysfunction is common in men with diabetes . OBJECTIVE To assess the efficacy and safety of oral sildenafil citrate in the treatment of erectile dysfunction in men with diabetes . DESIGN A multicenter , r and omized , double-blind , placebo-controlled , flexible dose-escalation study conducted May through November 1996 . SETTING Patients ' homes and 19 clinical practice centers in the United States . PATIENTS A total of 268 men ( mean age , 57 years ) with erectile dysfunction ( mean duration , 5.6 years ) and diabetes ( mean duration , 12 years ) . INTERVENTIONS Patients were r and omized to receive sildenafil ( n = 136 ) or placebo ( n = 132 ) as needed , but not more than once daily , for 12 weeks . Patients took the study drug or placebo 1 hour before anticipated sexual activity . The starting dose of sildenafil citrate was 50 mg , with the option to adjust the dose to 100 mg or 25 mg based on efficacy and tolerability , to be taken as needed . MAIN OUTCOME MEASURES Self-reported ability to achieve and maintain an erection for sexual intercourse according to the International Index of Erectile Function and adverse events . RESULTS Two hundred fifty-two patients ( 94 % ) completed the study ( 131/136 in the sildenafil group , 121/132 in the placebo group ) . By intention-to-treat analysis , at 12 weeks , 74 ( 56 % ) of 131 patients in the sildenafil group reported improved erections compared with 13 ( 10 % ) of 127 patients in the placebo group ( P proportion of men with at least 1 successful attempt at sexual intercourse was 61 % ( 71/ 117 ) for the sildenafil group vs 22 % ( 25/114 ) for the placebo group ( P Adverse events related to treatment were reported for 22 ( 16 % ) of 136 patients taking sildenafil and 1 ( 1 % ) of 132 patients receiving placebo . The most common adverse events were headache ( 11 % sildenafil , 2 % placebo ) , dyspepsia ( 9 % sildenafil , 0 % placebo ) , and respiratory tract disorder ( 6 % sildenafil , 2 % placebo ) , predominantly sinus congestion or drainage . The incidence of cardiovascular adverse events was comparable for both groups ( 3 % sildenafil , 5 % placebo ) . CONCLUSION Oral sildenafil is an effective and well-tolerated treatment for erectile dysfunction in men with diabetes",
"BACKGROUND Erectile dysfunction in men is common . We evaluated a system by which alprostadil ( prostagl and in E1 ) is delivered transurethrally to treat this disorder . METHODS Alprostadil was delivered transurethrally in a double-blind , placebo-controlled study of 1511 men , 27 to 88 years of age , who had chronic erectile dysfunction from various organic causes . The men were first tested in the clinic with up to four doses of the drug ( 125 , 250 , 500 , and 1000 microg ) ; those who had sufficient responses were r and omly assigned to treatment with either the effective dose of alprostadil or placebo for three months at home . RESULTS During in-clinic testing , 996 men ( 65.9 percent ) had erections sufficient for intercourse . Of these men , 961 reported the results of at least one home treatment ; 299 of the 461 treated with alprostadil ( 64.9 percent ) had intercourse successfully at least once , as compared with 93 of the 500 who received placebo ( 18.6 percent , P alprostadil administrations were followed by intercourse in men responsive to treatment . The efficacy of alprostadil was similar regardless of age or the cause of erectile dysfunction , including vascular disease , diabetes , surgery , and trauma ( P placebo ) . The most common side effect was mild penile pain , which occurred after 10.8 percent of alprostadil treatments , but the pain rarely result ed in refusal to continue in the study . Hypotension occurred in the clinic in 3.3 percent of men receiving alprostadil . Hypotension-related symptoms were uncommon at home . No men had priapism or penile fibrosis . CONCLUSIONS In men with erectile dysfunction , transurethral alprostadil therapy result ed in erections in the clinic and in intercourse at home"
] | 41163058-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Atraumatic restorative treatment ( ART ) has demonstrated good longevity when used for single-surface restorations , but lower success rates are reported for occlusoproximal surfaces . AIM This systematic review and meta- analysis aim ed to verify the pooled success rate of occlusoproximal ART restorations in primary teeth considering the outcomes : longevity , pulp damage , or caries lesion progression . DESIGN Literature search ing was carried out on the studies reporting clinical trials indexed in PubMed and in English language , comprising the outcomes . A meta- analysis was undertaken considering the results from review ed studies . RESULTS An initial search result ed in 126 articles , and three of them were finally selected . The main reasons for excluding articles were the absence of control group , as amalgam , composite resin , or compomer restorations to be compared with ART ( h and excavation + high-viscous GIC ) . The pooled estimate ( odds ratio ; 95 % confidence interval ) for ART approach success was 1.04 ( 0.65 - 1.66 ) . CONCLUSION Atraumatic restorative treatment restorations performed with high-viscous GIC present similar survival/success rates to conventional approach using composite resin or amalgam for occlusoproximal restorations in primary teeth and can be suggested as a good option for occlusoproximal cavities in primary molars . In addition , further r and omized controlled clinical investigations concerning occlusoproximal restorations in primary teeth are still necessary | [
"The survival rates of restorations in primary molars were calculated after a retrospective examination of patients ' dental records from a study population of 1,065 children . A r and om sample of 128 records showing information for 604 dental restorations was examined , coded , and analyzed by the life table method of survival analysis . The order of the survival rate of restorations from higher to lower success was preformed crowns , amalgam , composite resin , and glass ionomer restorations . A highly statistically significant difference ( P = 0.0001 ) was found among the survival success rates of different material restorations . For preformed crowns and amalgam restorations , the median survival time was more than 5 years . The 5-year survival estimate for preformed crowns was 68 % and for amalgam restorations was 60 % . For composite resin the median survival time was 32 months and the 4-year survival estimate was 40 % . For glass ionomer restorations , the median survival time was 12 months and the 4-year survival estimate was 5 %",
"BACKGROUND AND AIM This paper review s three published papers and adds results from a fourth study which aim ed to determine which restorative material would be the best alternative(s ) to amalgam ( AM ) in primary teeth . DESIGN All studies had a practice -based design and were part of the routine treatment of children and adolescents . The clinicians were assigned which material s to use in a r and omised matter in the first three studies which lasted for 7 - 8 years . In the fourth study conducted 4 years after the initial studies , the clinicians were free to select the restorative material s. RESULTS AND CONCLUSIONS Resin modified glass ionomer ( RMGI ) and compomer ( COM ) restorations showed similar longevity compared with AM , whereas conventional GI restorations showed significantly shorter longevity . The studies indicated that the ' new and improved ' material s based on in vitro tests did not always show enhanced clinical properties . In the last study , where clinicians freely selected the restorative material s they used in their practice s , seven used COM , one used conventional GI material s and one used a combination of the two types of material",
"OBJECTIVE To determine the examiner 's accuracy in selecting proximal carious lesions in primary molars for restoration using the atraumatic restorative treatment ( ART ) approach . BASIC RESEARCH DESIGN Intervention study . CLINICAL SETTING AND PARTICIPANTS : A total of 804 six to eight year-olds from 30 rural schools in Kenya participated in the study . INTERVENTION Three examiners selected a total of 1,280 suitable proximal carious lesions in primary molars after examining 6,002 children from 30 schools r and omly selected out of 142 schools in two divisions . Seven operators r and omly paired on a daily basis with eight assistants restored the lesions . An explanation was provided for any cavity that was not restored . Pre- and post-operative radiographs of the cavities were also taken for evaluation . MAIN OUTCOME MEASURES The examiner 's choice of suitable proximal cavities restorable using the ART approach was related to the decision made to either restore or not during the operative stage . The radiographic findings of the selected cavities were also compared to the decision made by the operator . The results obtained were used to determine the examiner 's accuracy in selecting suitable proximal cavities for restoration using the ART approach . RESULTS The majority of the children recruited in the study were excluded due to absenteeism , pulpal-exposure or anxiety during the operative stage . Only 804 children received one restoration in their primary molars . The examiner 's accuracy in selecting suitable ART-restorable cavities clinical ly was 94.9 % and based on radiographic analysis was 91.7 % . CONCLUSIONS A trained and diligent examiner has a very good chance of selecting proximal carious lesions restorable with the use of ART approach , without the threat of dental pulpal-involvement during the excavation of caries",
"PURPOSE The objectives of this clinical study were to : evaluate the survival of occlusal atraumatic restorative treatment ( ART ) restorations , on a longitudinal basis , in the primary molars of children in Mosul/Iraq ; and compare the success rate of ART restorations placed with and without cavity conditioning . METHODS One dentist placed 96 ART restorations in 48 6- to 7-year-olds who had bilateral matched pairs of carious primary molars . A split-mouth design was used to place restorations with and without cavity conditioning , which were assigned r and omly to contralateral sides . Restorations were evaluated after 6 and 12 months using the ART criteria . RESULTS The survival rate of ART restorations placed with cavity conditioner was 89 % at the 6-month assessment and 74 % at the 12-month assessment . The success rates of ART restorations placed without cavity conditioning in the 2 assessment s were 84 % and 67 % , respectively . There was no statistically significant difference between the ART restorations placed with and without cavity conditioner in both assessment s ( P>0.05 ) . The main cause of failure was the loss of restoration . CONCLUSIONS The 1-year success rate of occlusal ART restorations in primary molars was moderately successful . The ART technique 's cavity conditioning step was not proven to be better than not using it for Class I lesions",
"PURPOSE To evaluate the effect of a chlorhexidine-gluconate-based cavity disinfectant on the clinical performance of high viscosity glass-ionomer cement following the ART approach under field conditions after 24 months . METHODS 126 school children 6 - 8 years old who had bilateral matched pairs of carious Class I and II primary molars were included . A split mouth design was used in which Ketac Molar was r and omly placed with or without the use of chlorhexidine-gluconate-based cavity disinfectant on contralateral sides by three dentists . The restorations were evaluated after 6 , 12 and 24 months by two experienced examiners using USPHS-Ryge criteria . RESULTS The 24-month mean cumulative survival rates of Ketac Molar without the use of disinfectant were 97.7 % and 69.4 % while in the disinfectant group , the survival rates were 95.2 % and 63.9 % in Class I and II restorations , respectively with no significant difference between the groups in both class types . In the non-disinfected group , large Class II cavities had significantly better survival rates than did small Class II cavities ( P = 0.023 ) . In the disinfected group , the failure rates in mean cumulative survivals from 6 to 12 months and 12 to 24 months significantly increased with time ( P = 0.004 and P = 0.016 respectively )",
"PURPOSE The aim of this study was to evaluate the performance of two different glass ionomer cements using the Atraumatic Restorative Treatment ( ART ) technique in permanent teeth . MATERIAL S AND METHODS A total of 473 ART restorations were placed in 208 schoolchildren ( 7 - 12 years of age ) by two previously trained operators , using high density and resin-modified glass ionomer cements . All the restorations were photographed at baseline and the patients were asked about postoperative sensitivity . After a period of 8 months , 193 patients were present after recall and 428 restorations were evaluated and photographed . Two independent examiners carried out the evaluation . RESULTS The results showed a success rate of 86.2 % for occlusal restorations with Fuji IX and 88.4 % for those restored with Fuji Plus . A total of 86.7 % of the approximal restorations with Fuji Plus were also judged to be successful after 8 months . No association was found between the material s and the clinical performance of the ART restorations in class I cavities . CONCLUSION The type of restorative material did not influence the success or failure rates in class I cavities within this period . Fuji IX showed promising performance for occlusal ART restorations and Fuji Plus is also a promising material for occlusal and approximal ART restorations",
"BACKGROUND Limited information is available from r and omized clinical trials comparing the longevity of amalgam and resin-based compomer/composite restorations . The authors compared replacement rates of these types of restorations in posterior teeth during the five-year follow-up of the New Engl and Children 's Amalgam Trial . METHODS The authors r and omized children aged 6 to 10 years who had two or more posterior occlusal carious lesions into groups that received amalgam ( n=267 ) or compomer ( primary teeth)/composite ( permanent teeth ) ( n=267 ) restorations and followed them up semiannually . They compared the longevity of restorations placed on all posterior surfaces using r and om effects survival analysis . RESULTS The average+/-st and ard deviation follow-up was 2.8+/-1.4 years for primary tooth restorations and 3.4+/-1.9 years for permanent tooth restorations . In primary teeth , the replacement rate was 5.8 percent of compomers versus 4.0 percent of amalgams ( P=.10 ) , with 3.0 percent versus 0.5 percent ( P=.002 ) , respectively , due to recurrent caries . In permanent teeth , the replacement rate was 14.9 percent of composites versus 10.8 percent of amalgams ( P=.45 ) , and the repair rate was 2.8 percent of composites versus 0.4 percent of amalgams ( P=.02 ) . CONCLUSION Although the overall difference in longevity was not statistically significant , compomer was replaced significantly more frequently owing to recurrent caries , and composite restorations required seven times as many repairs as did amalgam restorations . CLINICAL IMPLICATION S Compomer/composite restorations on posterior tooth surfaces in children may require replacement or repair at higher rates than amalgam restorations , even within five years of placement",
"The purpose of the study was to evaluate , in a clinical study over 2 years , the deterioration of two glass ionomer cements used with the atraumatic restorative treatment ( ART ) technique or approach . Fifty-five Fuji IX and 45 ChemFil Superior restorations were placed r and omly in 23 adult patients , mainly in small occlusal preparations in molar teeth . The restorations were placed in a dental hospital by one dentist using the ART technique . Photographs , radiographs and replicas were obtained at baseline and subsequent recalls . Both cements were easy to mix and place , but the radiolucency of ChemFil Superior was a disadvantage . Both cements also showed early high losses of sealant and restorative material . After 2 years , 34.5 % of the sealants appeared to be completely lost , with caries recorded in 5.3 % of the exposed fissures . In some instances , these small lesions may have been present , but not detected clinical ly , at the time of sealing . Restoration failures of 7.0 % were from wear and fracture of the cements and recurrent caries . Mean cumulative wear was 83.1 microm for Fuji IX and 104.0 microm for ChemFil Superior , which was not statistically significant . The cements became darker after their placement to more closely match the restored teeth , but there were few exact matches . There was no surface staining and only minor marginal discrepancies and staining associated with the restorations . Although the short-term clinical performance of the two glass ionomer cements was reasonable , the material s require further improvements in their mechanical properties , to reduce sealant losses and wear . The cements evaluated appear suitable for restricted use only , in posterior teeth",
"AIM This was to evaluate the influence of two methods of tooth-isolation on the survival rate of proximal ART restorations in the primary molars . METHODS The study was conducted in two rural divisions in Kenya , with 7 operators r and omly paired to a group of 8 assistants . A total of 804 children each had one proximal cavity in a primary molar restored using the ART approach . During restorations 2 isolation methods , rubber dam or cotton wool rolls , and 3 br and s of glass ionomer cements were used by the operators . The restorations were then followed for a period of 2 years . STATISTICS SPSS 14.0 was used to analyse and relate the data obtained to the method of isolation used . RESULTS After 2 years 30.8 % of the ART restorations had survived . Higher survival rates of the restorations were obtained when using rubber dam irrespective of the GIC material or the operator . CONCLUSION Generally the survival rate of the proximal restorations in the present study was very low , but the use of rubber dam result ed in a higher survival rate of the restorations",
"Successful use of atraumatic restorative treatment ( ART ) in children has been reported , but little information is available regarding its use in older adults . The hypothesis of this study was that survival rates of root restorations placed by both ART and the conventional technique were similar . Root-surface caries lesions in 103 institutionalized elders in Hong Kong were treated r and omly by either : ( 1 ) the conventional approach — caries removed by dental burs , and the cavity filled with light-cured resin-modified glass ionomer ; or ( 2 ) the ART approach — caries removed by h and instruments , and the cavity filled with chemically cured high-strength glass ionomer . In total , 84 conventional and 78 ART restorations were placed . After 12 months , 63 conventional and 59 ART restorations were review ed , and the respective 12-month survival rates were 91.7 % and 87.0 % ( p > 0.05 ) . It is concluded that the survival rates of both types of root restorations were high and similar",
"Pain during invasive treatment of dental caries is a common phenomenon , if no local analgesia has been used before cavity preparation . Atraumatic restorative technique ( ART ) is a suggested procedure which is at least less traumatic for the patient . Although the ART approach has been received well by both children and adults who belong to population groups hardly ever exposed to regular oral health care , it has not yet been proven that this particular procedure really causes less pain , compared to more conventional techniques with rotating instruments . In the present study , pain was reported in connection with tooth restoration in 19.3 percent of the cases , when the ART technique was used , which is significantly less than with a conventional restorative technique ( 35.7 percent ) . Finally the results show a clear relationship in the pain reports between the first and the following treatments in both ART and the conventional technique groups",
"The aim of the present clinical study was an in vivo evaluation of an improved conventional glass ionomer cement Ketac Molar ( ESPE ) , compared to a polyacid modified composite resin , Dyract ( Dentsply/De Trey ) , used in primary molars . Fifty-three Ketac Molar and fifty-two Dyract restorations were placed in box-only preparations in primary molars . The application time for the chemically cured Ketac Molar , was longer compared to the light-cured Dyract . In comparing the material s , no differences were found , comparing both material s regarding secondary caries , marginal adaptation , wear and fracture toughness . One case of recurrent caries adjacent to a Ketac Molar restoration and two cases in the Dyract group were reported . Two Ketac Molar restorations and one Dyract showed bulk fracture at the time of evaluation . At the twelve-month evaluation , no difference between the investigated material s was registered , which indicates that Ketac Molar can be used as a proximal restoration in the primary dentition . It should be emphasized , however , that one-year data should not be extrapolated to indicate the long-term success of restorations",
"This study compared the survival of restorations produced through the atraumatic restorative treatment ( ART ) approach using glass-ionomer with those produced through the traditional approach using amalgam ( MTA ) in deciduous dentitions over a period of 3 years . Using a parallel group design , 835 grade 1 children , aged 6–7 years , participated . A total of 482 children were treated through the ART and 353 children through the MTA approach . Eight dentists produced a total of 1,891 single- and multiple-surface restorations . After 3 years , 22.1 % of the restorations were lost for evaluation . There was a statistically significant difference in the combined survival of all single- and multiple-surface restorations between the two approaches in favour of the ART approach ( p = 0.04 ) . The study revealed a 3-year cumulative survival percentage of single-surface ART and MTA restorations of 86.1 and 79.6 % , respectively . The difference was statistically significant ( p = 0.03 ) . The main reasons for both single-surface ART and MTA restorations to fail was ‘ restoration missing ’ followed by ‘ gross marginal defect ’ . The 3-year cumulative survival percentages of multiple-surface ART and MTA restorations were 48.7 and 42.9 % , respectively . The difference was not statistically significant ( p > 0.05 ) . The 3-year survival percentages of single- and multiple- surface ART and MTA restorations varied widely amongst the 8 operators with an operator effect ( p = 0.001 ) for multiple-surface MTA restorations . It can be concluded that the ART approach using glass-ionomer yielded better results in treating dentinal lesions in deciduous teeth than did the traditional approach using amalgam after 3 years . It is recommended to select the ART approach to complement the other activities of the school oral health programme",
"BACKGROUND The authors evaluated the 24-month performance of a packable resin-based composite/dentin bonding system and a high-viscosity glass ionomer cement ( GIC ) in restorations placed in primary molars with the atraumatic restorative treatment ( ART ) approach . METHODS Three dentists placed 419 restorations in 219 children aged 6 through 10 years who had bilateral matched pairs of carious posterior Class I and II primary teeth . They used a split-mouth design to place the two material s , which were assigned r and omly to contralateral sides . The authors evaluated the restorations according to U.S. Public Health Service Ryge criteria . RESULTS After 24 months , 96.7 percent of the Class I GIC restorations and 91 percent of the resin-based composite restorations survived , while the success rates for the Class II restorations were 76.1 percent and 82 percent for the GIC and resin-based composite restorations , respectively . The survival rate of the Class II resin-based composite restorations was 5.9 percent higher than that of the GIC restorations at the 24-month evaluation , but this difference was not statistically significant . However , the study results showed a statistically significant difference in survival rates between Class I and II restorations for both material s. CONCLUSION AND CLINICAL IMPLICATION S The two-year clinical performance of both material s was satisfactory for the restoration of Class I and II primary molars using the ART approach",
"OBJECTIVES The aims of this study are to assess the feasibility of the Atraumatic Restorative Treatment ( ART ) approach in primary teeth and to compare the ART approach with traditional amalgam restorations in primary molars . METHODS This study was conducted in a paediatric dentistry clinic in Kuwait between April 1999 and December 2001 . The ART and amalgam restorations were placed r and omly on comparable pairs of primary molars , if available . In addition , the ART approach was used for other primary teeth that had no pulpal involvement and no perceived pain before treatment . The restorations were assessed by both the ART evaluation criteria and USPHS criteria in August-September 2000 and in August-December 2001 . The mean follow-up period for the restorations was 8.3 months in the first assessment ( 2000 ) and 22 months in the second assessment ( 2001 ) . The assessment was possible for 35 children ( mean age = 5.7 years ) , 18 of whom had comparable pairs ( n = 35 pairs ) of restorations in their primary molars . In addition , 48 other ART restorations were assessed in 2000 and 42 in 2001 . RESULTS In a 2-year follow-up , 89.6 % of all ART restorations were considered successful . The failure rate of the comparable pairs of ART and amalgam restorations was 5.7 % . There was no significant difference in success rate between ART and amalgam techniques . CONCLUSIONS Based on a 2-year follow-up evaluation , the class I ART restorations seemed to have a high success rate , indicating the appropriateness of the ART approach in primary teeth",
"Atraumatic Restorative Treatment , ART , is a method of minimal caries intervention that uses only h and instruments . The aim of the present study was to explore a possible difference between the extent of discomfort experienced during dental treatment according to the ART approach and a method using rotary instruments . The study was performed in Indonesia . A total of 403 children were r and omly divided in two groups . In each child , one class II restoration in a deciduous molar was made . One group received treatment using rotary instruments ( 750 r.p.m . ) . The other group was treated according to the ART approach . Glass ionomer cement was used for restoration in both groups . Discomfort scores were determined using both physiological measurements ( heart rate ) and behavioral observations ( Venham ) on specific moments during the treatment . Venham scores showed a marked difference between the two groups at most time points . Heart rate measurements were different at deep excavation . Also , a clear relation between Venham scores and heart rate measurements could be found at all time points . Confounding could be shown for operating dentist , gender of the patient and initial anxiety , not for age . No effect modification could be shown . It can be concluded that children treated according to the ART approach using h and instruments alone experience less discomfort than those treated using rotary instruments",
"Dental caries continues to be a highly prevalent disease among Brazilian preschoolers , especially those with low socioeconomic status . The purpose of this r and omized , controlled trial was to evaluate in vivo 245 simplified restorations in deciduous molars using glass ionomer cements ( Vidrion R and Ketac-Molar ) . Dental restorations were evaluated at 6- and 12-month follow-ups . The teeth restored with Vidrion R ( SS White ) on a single tooth surface were successful in 87 % of the cases evaluated at 6 months and in 63 % at 12 months . The teeth restored with Ketac-Molar on one surface achieved a success rate of 95 % at 6 months and 82 % at 12 months . No recurrent caries or pulpal infection was evident . Logistic regression analysis demonstrated that teeth with cavities restricted to the occlusal surface on sclerotic dentin showed the best adhesion to the restorative material . The restorations with Ketac-Molar had a better clinical performance than those with Vidrion",
"PURPOSE To evaluate the clinical behavior of a compomer restorative system , Dyract AP , placed in combination with Non-Rinse Conditioner and Prime&Bond NT in permanent posterior teeth . MATERIAL S AND METHODS Fifty Class II and 41 Class I restorations were placed in 39 patients in a dental teaching hospital . The restorations were evaluated directly at baseline and after 6 , 12 and 24 months using the modified USPHS-Ryge criteria . Clinical photographs , polyvinylsiloxane impressions and bitewing radiographs of each restoration were taken for indirect assessment . RESULTS After 2 years , all 76 restorations were evaluated in situ . Color matching ability and surface characteristics were excellent . A gradual deterioration in marginal discoloration and marginal integrity was noted . The percentages of Alfa scores for each criterion at the 24-month evaluation were : color match 96 % , marginal discoloration 50 % , marginal integrity 26 % , anatomic form 97 % and surface texture 95 % . Five of the restorations ( 6 % ) had experienced partial fracture or recurrent caries . After 6 , 12 and 24 months , the net mean occlusal wear values were 18.5 microm , 35.7 microm and 55.9 microm , respectively . There was no statistically significant difference between Class I and II restorations for each criterion ( Fisher 's exact test , P > 0.05 )",
"The purpose of this in vivo study was to evaluate the clinical performance of a posterior composite resin TP.H ( Caulk Dentisply ) in class I restorations in primary molars . A total of 30 children aged 5 to 8 years old with 49 class I dental lesions in primary molars participated in the study . The cavity preparations involved removal of carious lesion only and the enamel margins were beveled . The results showed after 30 months that , 82 % ( 32/39 ) of Alfa ratings and 18 % ( 7/39 ) of Bravo ratings . We concluded that the composite resin TP-H could be used in conservative restorations in primary molars , particularly in the late mixed dentition",
"The purpose of this study was to determine and compare the shear bond strength of a conventional glass-ionomer cement , a resin modified glass-ionomer , a composite resin and three compomer restorative material s. Dentin of the occlusal surfaces from sixty extracted human permanent molars were prepared for shear bond strength testing . The specimens were r and omly divided into six groups of 10 each . Dentinal surfaces were treated according to the instructions of manufacturers for each material . Each restorative material was placed inside nylon cylinders 2 mm high with an internal diameter of 3 mm , which were placed perpendicular to dentin surfaces . Shear bond strengths were determined using an Universal Testing Machine at crosshead speed of 0.5 mm/min in a compression mode . Conventional glass-ionomer , Ketac-Molar aplicap showed the lowest mean shear bond strength 3.77+/-1.76 ( X + /- SD MPa ) and the composite resin , Heliomolar showed the highest mean shear bond strength 16.54+/-1.65 while the mean bond strength of Fuji II LC was 9.55+/-1.06 . The shear bond strengths of compomer restorative material s were 12.83+/-1.42 , 10.64+/-1.42 and 11.19+/-1.19 for Compoglass , Hytac and Dyract respectively . ANOVA revealed statistically significant differences in the mean shear bond strengths of all groups ( P0.5 ) . Ketac-Molar and composite resin showed statistically significant difference ( P mode of fracture varied between material s. It is concluded that the compomer restorative material s show higher shear bond strength than conventional glass-ionomer and resin modified glass-ionomer , but less than composite resin . The fracture mode is not related to the shear bond strengths values",
"Objective : To compare the clinical performance of two glass – ionomer cements , ChemFlex ( Dentsply DeTrey ) and Fuji IX GP ( GC ) , when used with the atraumatic restorative treatment ( ART ) approach in China . Methods : Eighty – nine school children aged between 6 and 14 years who had bilateral matched pairs of carious posterior teeth were included . A split – mouth design was used in which the two material s were r and omly placed on contralateral sides . The performance of the restorations was assessed directly and also indirectly from die – stone replicas at baseline and after 6 , 12 , and 24 months . Results : The 24–month cumulative survival rates of ART restorations in the primary teeth were 93 and 90 % for the ChemFlex and Fuji IX GP class I restorations , respectively , while 40 and 46 % of class II restorations placed with the respective material s were satisfactory . In the permanent dentition , only class I restorations were involved and the cumulative survival rates were 95 and 96 % for ChemFlex and Fuji IX GP . For the primary teeth after 24 months , net mean occlusal wear was 87 µm for ChemFlex and 85 µm for Fuji IX GP . The occlusal wear in the permanent teeth was 75 µm for ChemFlex and 79 µm for Fuji IX GP . Conclusion : The clinical performance of both material s over a 24–month period was similar and the survival rates of class I ART restorations in both primary and permanent teeth were high",
"OBJECTIVES the purpose of this study was to determine the mineral loss on surrounding enamel restored with glass ionomer cements ( GIC ) after erosive and cariogenic challenges . METHODS Bovine enamel specimens were r and omly assigned into six groups according to the restorative material : G1 - composite resin ; G2 - high viscous GIC ; G3 - resin-modified glass ionomer with nanoparticles ; G4 - encapsulated resin-modified GIC ; G5 - encapsulated high viscous GIC ; G6 - resin-modified GIC . After restorative procedures , half of specimens in each group were su bmi tted to caries challenge using a pH cycling model for 5 days , and the other half were su bmi tted to erosive challenge in citric acid for 10 min . Before and after the challenges , surface Knoop microhardness assessment s were performed and mineral changes were calculated for adjacent enamel at different distances from restorative margin . RESULTS Data were compared for significant differences using two-way ANOVA and Student-Newman-Keuls tests ( p Erosive challenge significantly reduced enamel surface hardness , but no significant difference was observed irrespectively restorative material s ( p>0.05 ) . The cariogenic challenge promoted a higher surface hardness loss for the resin-modified GIC ( G4 ) and only for the High viscous GIC ( G2 ) an increase in surface hardness was observed . For enamel analyses , significant differences were observed with respect to the different material s ( p mineral loss and specimens restored with the conventional high viscous GIC and the encapsulated resin-modified GIC presented the lowest values for mineral loss . CONCLUSION The GICs exerts protective effect only for cariogenic challenge"
] | 41163094-06ff-11f0-808a-c43d1ab1c353 |
Because there are several ways to cement glass-fiber posts ( GFPs ) into root canals , there is no consensus on the best strategy to achieve high bond strengths . A systematic review was conducted to determine if there is difference in bond strength to dentin between regular and self-adhesive resin cements and to verify the influence of several variables on the retention of GFPs . This report followed the Preferred Reporting Items for Systematic Review s and Meta-Analyses statement . In vitro studies that investigated the bond strength of GFPs luted with self-adhesive and regular resin cements were selected . Search es were carried out in the PubMed and Scopus data bases . No publication year or language limit was used , and the last search was done in October 2012 . A global comparison was performed between self-adhesive and regular resin cements . Two subgroup analyses were performed : 1 ) Self-adhesive × Regular resin cement + Etch- and -rinse adhesive and 2 ) Self-adhesive × Regular resin cement + Self-etch adhesive . The analyses were carried out using fixed-effect and r and om-effects models . The results showed heterogeneity in all comparisons , and higher bond strength to dentin was identified for self-adhesive cements . Although the articles included in this meta- analysis showed high heterogeneity and high risk of bias , the in vitro literature seems to suggest that use of self-adhesive resin cement could improve the retention of GFPs into root canals | [
"OBJECTIVES To evaluate the push-out bond strength and the sealing ability of five adhesive cements routinely used for fiber-post bonding . METHODS Fifty extracted single-rooted teeth were r and omly divided in five groups and restored using Parapost FiberLux and the following luting agents : Panavia 21 ( PAN ) , Clearfil Esthetic Cement ( CLF ) , Variolink II ( VAR ) , RelyX Unicem ( UNI ) and experimental GC self-adhesive cement ( EGC ) . After 1 week of water storage at 37 degrees C , three sections ( coronal , middle and apical ) of 2 mm thickness were prepared from each specimen . Sealing ability was quantified with a fluid-filtration system ( Flodec ) during 10 min , after which the push-out bond strength was immediately measured . Data were analyzed with ANOVA ( push-out ) and Kruskal-Wallis ( sealing ability ) . RESULTS The push-out bond strength and sealing ability were not significantly different among the coronal , middle and apical sections for each luting agent . The highest push-out bond strength was measured for CLF ( 14.60+/-3.63 MPa ) , which was not significantly different from PAN ( 12.57+/-2.45 MPa ) , but significantly higher than VAR ( 11.09+/-4.09 MPa ) , UNI ( 11.29+/-4.31 MPa ) and EGC ( 7.65+/-4.79 MPa ) . When evaluating the sealing ability , significant differences were not found among PAN , CLF and VAR , and between UNI and EGC . The latter luting agents scored significantly lower than the former ones . The push-out bond strength was correlated to the sealing ability ( p self-etching MDP-based cements presented the highest push-out bond strength . Although the bonding effectiveness of self-adhesive cements appears promising , their interaction with root dentin might be too weak to minimize microleakage at the post-cement-dentin interface",
"OBJECTIVES This retrospective study investigated the clinical effectiveness over up to 8 years of parallel-sided and of tapered glass-fiber posts , in combination with either hybrid composite or dual-cure composite resin core material , in endodontically treated , maxillary anterior teeth covered with full-ceramic crowns . METHODS The study population comprised 192 patients and 526 endodontically treated teeth , with various degrees of hard-tissue loss , restored by the post- and -core technique . Four groups were defined based on post shape and core build-up material s , and within each group post- and -core restorations were assigned r and omly with respect to root morphology . Inclusion criteria were symptom-free endodontic therapy , root-canal treatment with a minimum apical seal of 4 mm , application of rubber dam , need for post- and -core complex because of coronal tooth loss , and tooth with at least one residual coronal wall . Survival rate of the post- and -core restorations was determined using Kaplan-Meier statistical analysis . RESULTS The restorations were examined clinical ly and radiologically ; mean observation period was 5.3 years . The overall survival rate of glass-fiber post- and -core restorations was 98.5 % . The survival rate for parallel-sided posts was 98.6 % and for tapered posts was 96.8 % . Survival rates for core build-up material s were 100 % for dual-cure composite and 96.8 % for hybrid light-cure composite . CONCLUSIONS For both glass-fiber post design s and for both core build-up material s , clinical performance was satisfactory . Survival was higher for teeth retaining four and three coronal walls",
"This study examined the contribution of testing time on the interfacial strengths of fiber posts to radicular dentin . Twenty-five fiber posts were luted to root segments with resin cements and a zinc phosphate cement . Immediately upon setting of the material s , the roots were sectioned into slices and r and omly divided into two subgroups , depending on testing time ( immediate vs. 24-hours ) , for push-out test . The results showed an improvement on the interfacial strength after 24 hours of storage . When data were pooled for each cement , the interfacial strengths ( MPa ) were : Optibond Solo Plus/Nexus : 10.3+/-3.8a ; zinc phosphate cement : 10.1+/-2.7a ; Multilink : 9.6+/-3.8ab ; RelyX Unicem : 7.1+/-4.9bc ; AllBond 2/Duolink : 6.7+/-3.5c ( groups with same superscript letter were not statistically significant ) . It is concluded that bond strength can increase during the first 24 hours and that the interfacial strength is predominantly contributed by frictional retention",
"PURPOSE This controlled clinical trial aim ed to compare the 3-year outcomes of glass fiber posts and composite cores with gold alloy-based posts and cores for the restoration of endodontically treated teeth . MATERIAL S AND METHODS One hundred forty-four patients in need of 205 restorations on endodontically treated teeth were selected and followed for 7 to 37 months ( mean : 21 ± 9 months ) . The teeth were primarily stratified based on the remaining tissue available to restore the tooth core with or without a post . Then , r and omization allocated the teeth to either test group 1 ( prefabricated glass fiber posts ) , test group 2 ( custom-made glass fiber posts ) , or test group 3 ( composite cores without posts ) . The control group consisted of gold alloy-based posts and cores . All posts/cores were covered with all-ceramic single crowns . Failures were either absolute , such as root fractures or irreparable fractures of the post/core , or relative , such as loss of post retention or reparable fractures of the core . Success and survival probability lifetime curves , corrected for clustering , were drawn for the entire data set . RESULTS The recall rate at 3 years was 97.1 % . Absolute failures consisted of two root fractures and one endodontic failure , while relative failures included three instances of retention loss of the post/core and one post fracture . Because of the low number of events , no statistical tests were performed . The success and survival probabilities over all groups together at 3 years amounted to 91.7 % and 97.2 % , respectively . CONCLUSIONS After being followed for up to 3 years , both cast gold and composite post and core systems performed well clinical ly . Longer follow-up times are needed to detect possible significant differences . Int J Prosthodont 2011;24:363 - 372",
"OBJECTIVES The aim of this study is to provide prospect i ve clinical data for the survival of postendodontic reconstructions of teeth with varying degrees of hard tissue loss using tapered or parallel-sided post shapes . METHODS Eighty-three patients got 105 glass fibre reinforced posts of tapered ( Luscent Anchors , Dentatus , Sweden ) and parallel-sided , serrated ( FibreKor , Jeneric Pentron , USA ) post shape . A dual curing hybrid composite Compolute ( 3 M ESPE , Germany ) was used as luting material , EBS-Multi ( 3 M ESPE ) as adhesive system and Clearfil Core ( Kuraray , Japan ) for core built-up . The restorations were followed for a minimum of 24 months . The statistical analysis was performed on a r and om sub- sample of one restoration per subject . The Fisher exact test was used to compare frequencies of failures after 12 and 24 month . A Kaplan-Meier- analysis was used to analyse time-to-failure in both groups . Differences of survival time between post types were tested with the log-rank test . RESULTS 3.8 % of the restorations failed after 12 month , 12.8 % after 24 month , respectively . The main failure type observed was post fractures . All but one failed teeth could be restored . There was no difference in failure frequency between post types after 12 or 24 months . The log-rank test showed no differences in survival between the two types of post ( p=0.37 ) . CONCLUSION Parallel-sided and tapered glass fibre posts result after 2 years of clinical service in an equal rate of survival",
"AIM To compare regional bond strength in different thirds of the root canal , among glass fiber-reinforced ( FRC ) endodontic posts luted with different cements , using the push-out test . MATERIAL AND METHODS Sixty extracted human anterior teeth were endodontically treated with gutta-percha and AH Plus sealer . The crown portion was removed , and a dowel space was prepared . Prepared teeth were r and omly assigned to one of six groups ( n = 10 ) for luting glass FRC Postec posts , with one of the six cement systems ( Ketac Cem Aplicap , Relyx Unicem Aplicap , Variolink II/Excite DCS , Panavia F/ED Primer , C&B cement/All-Bond 2 , and Multilink/Multilink Primer A/B ) , using an alignment technique . Specimens were embedded in resin , and each root was sectioned into six 1-mm thick serial slices . A push-out test was performed to measure regional bond strengths and to identify the type of failure . RESULTS The highest bond strength values were found in the cervical third and the lowest in the apical third . Highest values were obtained using Variolink II , Panavia F , and Multilink resin cements followed by C&B resin cement and Relyx Unicem ionomer resin cement ; Ketac-cem ionomer cement showed the lowest value . CONCLUSION Highest bond strength values were obtained in the cervical third and with resin cements",
"INTRODUCTION This is the first clinical long-term pilot study that tested the biomimetic concept of using more flexible , dentine-like ( low Young modulus ) glass fiber-reinforced epoxy resin posts ( GFREPs ) compared with rather rigid , stiff ( higher Young modulus ) titanium posts ( TPs ) in order to improve the survival rate of severely damaged endodontically treated teeth . METHODS Ninety-one subjects in need of postendodontic restorations in teeth with 2 or less remaining cavity walls were r and omly assigned to receive either a tapered TP ( n = 46 ) or a tapered GFREP ( n = 45 ) . The posts were adhesively luted using self-adhesive resin cement . The composite core build-ups were prepared ensuring a circumferential 2-mm ferrule . The primary endpoint was a loss of restoration for any reason . To study group differences , the log-rank test was calculated ( P failed ( ie , 4 GFREPs and 3 TPs ) . The failure modes were as follows : GFREP : root fracture ( n = 3 ) , core fracture ( n = 1 ) and TP : endodontic failure ( n = 3 ) . No statistical difference was found between the survival rates ( GFREPs = 90.2 % , TPs = 93.5 % , P = .642 ) . The probability of no failure was comparable for both post material s ( risk ratio ; 95 % confidence interval , 0.965 - 0.851/1.095 ) . CONCLUSIONS When using self-adhesive luted prefabricated posts in severely destroyed abutment teeth with 2 or less cavity walls and a 2-mm ferrule , postendodontic restorations achieved high long-term survival rates irrespective of the post material used ( ie , glass fiber vs titanium )"
] | 411630d0-06ff-11f0-808a-c43d1ab1c353 |
Background Shoulder pain in the general population is common and to identify the aetiology of shoulder pain , history , motion and muscle testing , and physical examination tests are usually performed . Objective The aim of this systematic review was to summarise and evaluate intrarater and inter-rater reliability of physical examination tests in the diagnosis of shoulder pathologies . Methods A comprehensive systematic literature search was conducted using MEDLINE , EMBASE , Allied and Complementary Medicine Data base ( AMED ) and Physiotherapy Evidence Data base ( PEDro ) through 20 March 2015 . Method ological quality was assessed using the Quality Appraisal of Reliability Studies ( QAREL ) tool by 2 independent review ers . Results The search strategy revealed 3259 articles , of which 18 finally met the inclusion criteria . These studies evaluated the reliability of 62 test and test variations used for the specific physical examination tests for the diagnosis of shoulder pathologies . Method ological quality ranged from 2 to 7 positive criteria of the 11 items of the QAREL tool . Conclusions This review identified a lack of high- quality studies evaluating inter-rater as well as intrarater reliability of specific physical examination tests for the diagnosis of shoulder pathologies . In addition , reliability measures differed between included studies hindering proper cross- study comparisons . Trial registration number PROSPERO CRD42014009018 | [
"We describe the biceps load test for evaluating the integrity of the superior glenoid labrum in shoulders with recurrent anterior dislocations . With the shoulder in an abducted , externally rotated position and the forearm supinated , active flexion of the elbow against resistance relieves the discomfort of a st and ard apprehension test for anterior shoulder instability . A group of 75 patients with proven unilateral anterior shoulder dislocations were prospect ively examined in a double-blind fashion with arthroscopic examination and the biceps load test . Sixty-three patients had a negative test and 62 of these had an intact biceps tendon-superior labrum complex ; the remaining patient had a type II superior labral anterior and posterior lesion . Twelve patients had positive tests , and 10 had superior labral lesions ; the other 2 patients had intact superior labra . Therefore , the biceps load test revealed a sensitivity of 90.9 % , a specificity of 96.9 % , a positive predictive value of 83 % , a negative predictive value of 98 % , and a kappa coefficient of 0.846",
"Background Painful shoulders pose a substantial socioeconomic burden . A prospect i ve cost-of-illness study was performed to assess the costs associated with healthcare use and loss of productivity in patients with shoulder pain in primary health care in Sweden . Methods The study was performed in western Sweden , in a region with 24 000 inhabitants . Data were collected during six months from electronic patient records at three primary healthcare centres in two municipalities . All patients between 20 and 64 years of age who presented with shoulder pain to a general practitioner or a physiotherapist were included . Diagnostic codes were used for selection , and the cases were manually controlled . The cost for sick leave was calculated according to the human capital approach . Sensitivity analysis was used to explore uncertainty in various factors used in the model . Results 204 ( 103 women ) patients , mean age 48 ( SD 11 ) years , were registered . Half of the cases were closed within six weeks , whereas 32 patients ( 16 % ) remained in the system for more than six months . A fifth of the patients were responsible for 91 % of the total costs , and for 44 % of the healthcare costs . The mean healthcare cost per patient was € 326 ( SD 389 ) during six months . Physiotherapy treatments accounted for 60 % . The costs for sick leave contributed to 84 % of the total costs . The mean annual total cost was € 4139 per patient . Estimated costs for secondary care increased the total costs by one third . Conclusions The model applied in this study provides valuable information that can be used in cost evaluations . Costs for secondary care and particularly for sick leave have a major influence on total costs and interventions that can reduce long periods of sick leave are warranted",
"Background Although there are many studies describing tests for shoulder instability , there are few assessing the validity of these tests in diagnosing anterior shoulder instability . Purpose To assess the validity of the apprehension , relocation , and surprise tests as predictors of anterior shoulder instability . Study Design Retrospective review of prospect ively collected data . Methods Forty-six patients with a clear diagnosis of one of the following shoulder disorders were evaluated by four independent , blinded examiners : traumatic anterior instability ( 18 ) , rotator cuff tendinosis ( 17 ) , posterior instability ( 2 ) , glenohumeral osteoarthritis ( 4 ) , or multidirectional instability ( 5 ) . Interobserver reliability was also determined . Results In subjects who had a feeling of apprehension on all three tests , the mean positive and negative predictive values were 93.6 % and 71.9 % , respectively . The surprise test was the single most accurate test ( sensitivity = 63.89 % ; specificity = 98.91 % ) . An improvement in the feeling of apprehension or painwith the relocation test added little to the value of the tests . Interobserver reliability was determined to be 0.83 . Conclusions and Clinical Relevance The results of this study suggest that a positive instability exam on all three tests is highly specific and predictive of traumatic anterior glenohumeral instability",
"PURPOSE The purpose of this report is to describe the biceps load test II for evaluating the superior labral anterior and posterior ( SLAP ) lesions . TYPE OF STUDY This is a double-blind study in consecutive data , which includes diagnostic accuracy of a test using sensitivity , specificity , and interexaminer reliability . METHODS In the supine position , the arm is elevated to 120 degrees and externally rotated to its maximal point , with the elbow in the 90 degrees flexion and the forearm in the supinated position . The patient is asked to flex the elbow while resisting the elbow flexion by the examiner . The test is considered positive if the patient complains of pain during the resisted elbow flexion . The test is negative if pain is not elicited or if the pre-existing pain during the elevation and external rotation of the arm is unchanged or diminished by the resisted elbow flexion . A prospect i ve study was performed in 127 patients to evaluate the diagnostic accuracy for the biceps load test II . Two independent examiners were assigned to perform the new diagnostic test . The results of the tests were confirmed during the arthroscopic examination . RESULTS A positive test result in 38 subjects correlated with a SLAP lesion in 35 patients and an intact biceps-superior labrum in 3 patients . A negative test result in 89 patients correlated with an intact superior labrum complex in 85 patients , whereas 4 patients with a negative test result had a type II SLAP lesion . The biceps load test II had a sensitivity of 89.7 % , a specificity of 96.9 % , a positive-predictive value of 92.1 % , a negative-predictive value of 95.5 % , and a kappa coefficient of 0.815 . The abduction and external rotation of the shoulder during the test changes the relative direction of the biceps fiber in a position of oblique angle to the posterosuperior labrum . The resisted contraction of the biceps increases the pain generated on the superior labrum that is already peeled off the glenoid margin in the abducted and externally rotated position . CONCLUSIONS The biceps load test II is an effective diagnostic test for SLAP lesions",
"Background : Epidemiological research in the field of soft tissue neck and upper limb disorders has been hampered by the lack of an agreed system of diagnostic classification . In 1997 , a United Kingdom workshop agreed consensus definitions for nine of these conditions . From these criteria , an examination schedule was developed and vali date d in a hospital setting . Objective : To investigate the reliability of this schedule in the general population . Methods : Ninety seven adults of working age reporting recent neck or upper limb symptoms were invited to attend for clinical examination consisting of inspection and palpation of the upper limbs , measurement of active and passive ranges of motion , and clinical provocation tests . A doctor and a trained research nurse examined each patient separately , in r and om order and blinded to each other 's findings . Results : Between observer repeatability of the schedule was generally good , with a median κ coefficient of 0.66 ( range 0.21 to 0.93 ) for each of the specific diagnoses considered . Conclusion : As expected , the repeatability of tests is poorer in the general population than in the hospital clinic , but the Southampton examination schedule is sufficiently reproducible for epidemiological research in the general population",
"BACKGROUND Rotator cuff lesions are common in the community but reproducibility of tests for shoulder assessment has not been adequately appraised and there is no uniform approach to their use . OBJECTIVE To study interrater reproducibility of st and ard tests for shoulder evaluation among a rheumatology specialist , rheumatology trainee , and research nurse . METHODS 136 patients were review ed over 12 months at a major teaching hospital . The three assessors examined each patient in r and om order and were unaware of each other 's evaluation . Each shoulder was examined in a st and ard manner by recognised tests for specific lesions and a diagnostic algorithm was used . Between-observer agreement was determined by calculating Cohen 's kappa coefficients ( measuring agreement beyond that expected by chance ) . RESULTS Fair to substantial agreement was obtained for the observations of tenderness , painful arc , and external rotation . Tests for supraspinatus and subscapularis also showed at least fair agreement between observers . 40/55 ( 73 % ) kappa coefficient assessment s were rated at > 0.2 , indicating at least fair concordance between observers ; 21/55 ( 38 % ) were rated at > 0.4 , indicating at least moderate concordance between observers . CONCLUSION The reproducibility of certain tests , employed by observers of varying experience , in the assessment of the rotator cuff and general shoulder disease was determined . This has implication s for delegation of shoulder assessment to nurse specialists , the development of a simplified evaluation schedule for general practitioners , and uniformity in epidemiological research studies",
"OBJECTIVE To determine the interrater reliability of shoulder physical diagnosis signs in the acute stroke rehabilitation setting . DESIGN Prospect i ve inception cohort . SETTING Academic inpatient stroke rehabilitation service . PARTICIPANTS People admitted to stroke rehabilitation service . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES The Neer impingement test , Speed test , acromioclavicular shear test , Rowe shoulder score , and palpation . RESULTS Two examiners evaluated 46 consecutively admitted participants at 18.9+/-14.1 days after stroke . Percentage agreement was 78 % or higher on all tests . The kappa statistic was in the fair to excellent interrater reliability range on all tests except those involving the acromioclavicular joint , for which findings were infrequent . CONCLUSIONS Most of the shoulder physical diagnosis signs used in this study have sufficient interrater reliability for use in future clinical studies of hemiplegic shoulder pain",
"OBJECTIVE To investigate the reliability and diagnostic accuracy of individual tests and combination of tests for subacromial impingement syndrome ( SAIS ) . DESIGN A prospect i ve , blinded study design . SETTING Orthopedic surgeon shoulder clinic . PARTICIPANTS Patients with shoulder pain ( n=55 , mean age=40.6y ) . INTERVENTIONS Patients were evaluated with 5 physical examination tests for SAIS : Neer , Hawkins-Kennedy , painful arc , empty can ( Jobe ) , and external rotation resistance tests . Surgical diagnosis was the reference st and ard . MAIN OUTCOME MEASURES Diagnostic accuracy calculated with a receiver operating characteristic ( ROC ) curve and sensitivity , specificity , positive likelihood ratio ( + LR ) , and negative likelihood ratio ( -LR ) . A forward stepwise binary logistic regression analysis was used to determine the best test combination for SAIS . An ROC curve analysis was also used to determine the cut point of the number of tests discriminating between the presence and absence of SAIS . Kappa coefficients and percent agreement assessed interrater reliability . RESULTS The ROC analyses revealed a significant area under the curve ( AUC ) ( AUC=.67-.72 , P painful arc ( -LR=.38 ; 95 % CI , .16-.90 ) , external rotation resistance ( -LR=.50 ; 95 % CI , .28-.89 ) , and Neer tests ( -LR=.35 ; 95 % CI , .12-.97 ) . The regression analysis had no specific test combinations for confirming or ruling out SAIS . The ROC analysis was significant ( AUC=.79 , P=.001 ) , with a cut point of 3 positive tests out of 5 tests . Reliability was moderate to substantial agreement ( kappa=.45-.67 ) for the painful arc , empty can , and external rotation resistance tests and fair strength of agreement ( kappa=.39-.40 ) for the Neer and Hawkins-Kennedy tests . CONCLUSIONS The single tests of painful arc , external rotation resistance , and Neer are useful screening tests to rule out SAIS . The single tests of painful arc , external rotation resistance , and empty can are helpful to confirm SAIS . The reliability of all tests was acceptable for clinical use . Based on reliability and diagnostic accuracy , the single tests of the painful arc , external rotation resistance , and empty can have the best overall clinical utility . The cut point of 3 or more positive of 5 tests can confirm the diagnosis of SAIS , while less than 3 positive of 5 rules out SAIS"
] | 4116310c-06ff-11f0-808a-c43d1ab1c353 |
Background This systematic review examined the method ological quality of studies and assessed the psychometric qualities of interview-administered Past-week and Usual-week Physical Activity Question naires ( PAQs ) . Pubmed and Embase were used to retrieve data sources . Methods The studies were selected using the following eligibility criteria : 1 ) psychometric properties of PAQs were assessed in adults ; 2 ) the PAQs either consisted of recall periods of usual 7-days ( Usual-week PAQs ) within the past 12 months or during the past 7-days ( Past-week PAQs ) ; and 3 ) PAQs were interview-administered . The COSMIN taxonomy was utilised to critically appraise study quality and a previously established psychometric criteria employed to evaluate the overall psychometric qualities . Results Following screening , 42 studies were examined to determine the psychometric properties of 20 PAQs , with the majority of studies demonstrating good to excellent ratings for method ological quality . For convergent validity ( i.e. , the relationship between PAQs and other measures ) , similar overall associations were found between Past-week PAQs and Usual-week PAQs . However , PAQs were more strongly associated with direct measures of physical activity ( e.g. , accelerometer ) than indirect measures of physical activity ( i.e. , physical fitness ) , irrespective of recall methods . Very few psychometric properties were examined for each PAQ , with the majority exhibiting poor ratings in psychometric quality . Only a few interview-administered PAQs exhibited positive ratings for a single psychometric property , although the other properties were either rated as poor or question able , demonstrating the limitations of current PAQs . Conclusion Accordingly , further research is necessary to explore a greater number of psychometric properties , or to develop new PAQs by addressing the psychometric limitations identified in the current review | [
"There was a need to design a question naire that could accurately assess the activity patterns of Native Americans to evaluate the relationship between physical activity and diabetes . Such a question naire was developed and implemented into the data collection scheme of the prospect i ve Pima Indian Study of Arizona . The question naire , which assesses historical , past-year , and past-week leisure and occupational activity , was examined in 29 Pima individuals aged 21–36 yr and was shown to be reliable with test-retest correlations ( rank-order correlations ranged from 0.62 to 0.96 for leisure and occupational activity ) . Reproducibility of the past-year leisure physical-activity estimate was determined in 69 participants aged 10 - 59 yr and was found to be reliable in all age-groups with the exception of the 10- to 14-yr-old age-group ( rank-order correlations were 0.31 in the 10- to 14-yr-old age-group compared to 0.88 to 0.92 in those > 20 yr of age ) . Validity of the current-activity section of the question naire was demonstrated indirectly through comparisons with activity monitors . The past-week leisure-activity estimate was related to the Caltrac activity monitor counts per hour ( p = 0.62 , P > 0.05 , n = 17 ) . In summary , a physical-activity question naire has been developed that is both reliable and feasible to use in the Pima Indian population to evaluate the relationship of physical activity to non-insulin-dependent diabetes mellitus",
"BACKGROUND Quantifying lifetime physical activity using self-reported measures is challenging due to reliance on recall , especially in older population s. The purpose of this study was to determine the 1-year reproducibility of the Veterans Physical Activity Question naire ( VAPAQ ) in a cohort of patients with documented abdominal aortic aneurysm disease ( AAA ) . METHODS Subjects included men ( n = 52 ) and women ( n = 3 ) enrolled in AAA STOP , a r and omized trial design ed to test the ability of supervised exercise training to modify AAA biology and early disease progression . RESULTS The overall correlation coefficient for lifetime recreational energy expenditure between the 2 examinations was 0.93 ( P VAPAQ is a reproducible tool to quantify lifetime energy expenditure in older adults with documented vascular disease",
"Objective The Global Physical Activity Question naire ( GPAQ ) was originally design ed to be interviewer-administered by the World Health Organization in assessing physical activity . The main aim of this study was to compare the psychometric properties of a self-administered GPAQ with the original interviewer-administered approach . Additionally , this study explored whether using different accelerometry-based physical activity bout definitions might affect the question naire ’s validity . Methods A total of 110 participants were recruited and r and omly allocated to an interviewer- ( n = 56 ) or a self-administered ( n = 54 ) group for test-retest reliability , of which 108 participants who met the wear time criteria were included in the validity study . Reliability was assessed by administration of question naires twice with a one-week interval . Criterion validity was assessed by comparing against seven-day accelerometer measures . Two definitions for accelerometry- data scoring were employed : ( 1 ) total-min of activity , and ( 2 ) 10-min bout . Results Participants had similar baseline characteristics in both administration groups and no significant difference was found between the two formats in terms of validity ( correlations between the GPAQ and accelerometer ) . For validity , the GPAQ demonstrated fair-to-moderate correlations for moderate-to-vigorous physical activity ( MVPA ) for self-administration ( r s = 0.30 ) and interviewer-administration ( r s = 0.46 ) . Findings were similar when considering 10-min activity bouts in the accelerometer analysis for MVPA ( r s = 0.29 vs. 0.42 for self vs. interviewer ) . Within each mode of administration , the strongest correlations were observed for vigorous-intensity activity . However , Bl and -Altman plots illustrated bias toward overestimation for higher levels of MVPA , vigorous- and moderate-intensity activities , and underestimation for lower levels of these measures . Reliability for MVPA revealed moderate correlations ( r s = 0.61 vs. 0.63 for self vs. interviewer ) . Conclusions Our findings showed comparability between both self- and interviewer-administration modes of the GPAQ . The GPAQ in general but especially the self-administered version may offer a relatively inexpensive method for measuring physical activity of various types and at different domains . However , there may be bias in the GPAQ measurements depending on the overall physical activity . It is advisable to incorporate accelerometers in future studies , particularly when measuring different intensities of physical activity",
"PURPOSE To evaluate the criterion validity of the 7-Day Physical Activity Recall ( 7D-PAR ) and factors associated with reporting error , in a sample of moderately overweight , young adult men and women . METHODS Average total daily energy expenditure ( TDEE ) and physical activity energy expenditure ( PAEE ) from the 7D-PAR were compared with the same parameters assessed by doubly labeled water in 17 men , age = 23.9 + /- 3.8 yr , and 29 women , age = 23.3 + /- 4.6 yr , who volunteered to participate in a 16-month supervised aerobic exercise trial . PAEE was estimated from the 7D-PAR and from DLW [ 0.9 * TDEE -resting metabolic rate ( RMR ) ( indirect calorimetry ) ] . In addition , peak oxygen uptake and percent body fat were obtained . RESULTS No significant differences in TDEE ( kJ.d-1 ) were noted between the 7D-PAR ( 11825 + /- 1779 ) and DLW ( 11922 + /- 2516 ) for the complete sample ( N = 46 ) or for men ( 7D-PAR = 13198 + /- 1638 , DLW = 13885 + /- 2754 ) or women ( 7D-PAR = 11018 + /- 1323 , DLW = 10771 + /- 1457 . The mean PAEE from the 7D-PAR was not different from DLW in the total sample ( 7D-PAR = 3286 + /- 502 , DLW = 3508 + /- 1863 ) as well as in men ( 7D-PAR = 3650 + /- 490 , DLW = 3989 + /- 2461 ) and women ( 3073 + /- 377 , DLW = 3223 + /- 1360 ) . In a regression model , PAEE , peak oxygen uptake , gender and percent fat accounted for 86 % of the reporting error in total daily energy expenditure when using the 7D-PAR . CONCLUSION The 7D-PAR provided a reasonable estimate of both the mean TDEE and PAEE in this sample ; however , estimates of energy expenditure on an individual basis using the PAR were subject to considerable error",
"The effects of detraining subsequent to strength training on neuromuscular function were examined in 39 recent-onset rheumatoid arthritis ( RA ) patients . Eighteen age- and sex-matched healthy people ( H ) served as controls . Patients were r and omly allocated either to the experimental group ( PE ) , who carried out progressive strength training for 6 months , or to the control group ( PC ) , who maintained only their habitual physical activities . After 6 months , PE returned to their earlier physical activities and strength training was terminated . At baseline , the maximal strength of the trunk extensors ( not significant ) , grip strength and maximal dynamic strength and the shape of the force-time curve of the knee extensors were lower in PE and PC ( P maximal strength of all muscle groups without changes in the shape of the force-time curve . The increases in muscle strength in PE obtained by strength training were lost to a great degree during the detraining period for the isometric trunk extension ( P knee extension strength ( P grip strength . In PC , trunk extension and flexion strength decreased significantly throughout the study period . At the post-test , all the strength values in both patient groups were much lower than in H. RA is a chronic disease which seems to need continuous physical exercise with sufficient intensity to minimize/prevent the loss of muscle strength and functional capacity",
"A Physical Activity Scale for the Elderly ( PASE ) was evaluated in a sample of community-dwelling , older adults . Respondents were r and omly assigned to complete the PASE by mail or telephone before or after a home visit assessment . Item weights for the PASE were derived by regressing a physical activity principal component score on responses to the PASE . The component score was based on 3-day motion sensor counts , a 3-day physical activity dairy and a global activity self- assessment . Test-retest reliability , assessed over a 3 - 7 week interval , was 0.75 ( 95 % CI = 0.69 - 0.80 ) . Reliability for mail administration ( r = 0.84 ) was higher than for telephone administration ( r = 0.68 ) . Construct validity was established by correlating PASE scores with health status and physiologic measures . As hypothesized , PASE scores were positively associated with grip strength ( r = 0.37 ) , static balance ( r = + 0.33 ) , leg strength ( r = 0.25 ) and negatively correlated with resting heart rate ( r = -0.13 ) , age ( r = -0.34 ) and perceived health status ( r = -0.34 ) ; and overall Sickness Impact Profile score ( r = -0.42 ) . The PASE is a brief , easily scored , reliable and valid instrument for the assessment of physical activity in epidemiologic studies of older people",
"Assessment of habitual physical activity in epidemiologic and health education studies has been difficult . A seven-day physical activity recall interview was developed and administered in a community health survey , a r and omized clinical trial , and two worksite health promotion programs during 1979 - 1982 . These studies were conducted in several population s in California , Texas , Pennsylvania , and New Jersey . Energy expenditure estimates from the physical activity recall conformed to expected age- and sex-specific values in the cross-sectional community survey . Estimates of energy expenditure were also congruent with other questions on physical activity and job classification . In a r and omized , one-year exercise trial , the physical activity recall detected increases in energy expenditure in the treated group and was positively associated with miles run during training ( p less than 0.05 ) . Changes in energy expenditure were associated with changes in maximal oxygen uptake ( VO2max ( r = 0.33 , p less than 0.05 ) and body fatness ( r = -0.50 , p less than 0.01 ) at six months , and in high density lipoprotein-cholesterol ( r = 0.31 , p less than 0.05 ) and triglyceride ( r = -0.41 , p less than 0.01 ) at one year . The physical activity recall detected significant ( p less than 0.01 ) increases in energy expenditure in treatment groups in two worksite health promotion projects . These data suggest that the physical activity recall provides useful estimates of habitual physical activity for research in epidemiologic and health education studies",
"The aim of the present study was to determine the extent to which respondents provided the same answers to a health-related lifestyle question naire in self- and interviewer-administered forms . A total of 234 subjects completed a 110-item question naire in both interviewer and self-administered forms . Modes of administration were separated by a 2-week interval . The order was determined by r and om allocation . The presence and the extent of the tendency to give socially acceptable responses were evaluated using percentage of bias calculated as the ratio of the difference in proportion of positive responses or the mean between interviews and question naires and those in question naires . All percentages of bias were in the positive direction , ranging from 1.4 % ( physical exercise ) to 26.1 % ( general life stress ) . The average percentage of bias was higher in women than in men and were stronger for younger respondents . The age differences between interviewer and respondent were inversely and most strongly related to percentage of bias . Self- and interviewer-administered question naires yield very similar results in discriminating between subjects , but the interviewer-administered question naire showed systematic ally more desirable responses to questions related to lifestyle factors . The differences in characteristics between interviewer and respondent may be important determinants of the socially desirability bias in the interview",
"PURPOSE The Modifiable Activity Question naire ( MAQ ) is a physical activity question naire shown to be both valid and reliable and was initially design ed to be interviewer-administered . After translation and adaptation into French , the objective of the study was to compare past-year physical activity data obtained by self-administration of this question naire and by interviewer-administration . METHODS 84 subjects ( 22 men , 62 women , age 36 - 63 yr ) enrolled in an ongoing prospect i ve study in France ( the SUpplementation en VItamines et Minéraux AntioXydants or SU.VI.MAX study ) completed both versions of the question naire in a r and omized order with a mean ( SD ) delay of 7.9 ( 5.8 ) d between the two modes . Past-year leisure and occupational physical activity were expressed as both h x wk(-1 ) and MET-h x wk(-1 ) of activity , and television watching was expressed as h x d(-1 ) . Analysis of variance on ranks was used to compare activity variables obtained by self-administration and interview . Agreement was assessed by nonparametric intraclass correlation coefficients . RESULTS A significant effect of the mode of administration was found only for past-year leisure physical activity with lower values reported in self-administered conditions compared with interview . However , a high level of concordance between the two modes of administration was observed for all variables as shown by the intraclass correlation coefficients : 0.90 for leisure physical activity ( h x wk(-1 ) ) , 0.82 for occupational activity ( h x wk(-1 ) ) , 0.83 for total ( leisure and occupational combined ) physical activity ( h x wk(-1 ) ) , and 0.97 for television viewing ( h x d(-1 ) ) . CONCLUSIONS The agreement between the two modes of administration of the question naire suggests that the self-administered version of the MAQ is a valuable tool to assess past-year physical activity and inactivity in self-administered conditions . This instrument could be used in large-scale population studies investigating the relationships between physical activity and health outcomes ",
"The purpose of this study was to develop a brief physical activity interview for older adults ( Phone-FITT ) and evaluate its test-retest reliability and validity . Summary scores were derived for household , recreational , and total PA . Reliability was evaluated in a convenience sample from a fall-prevention study ( N = 43 , 79.4 + /- 2.9 years , 51 % male ) , and validity , in a r and om sample of individuals in older adult exercise programs ( N = 48 , 77.4 + /- 4.7 years , 25 % male ) . Mean time to complete the Phone-FITT was 10 min for participants sample d from exercise programs . Evaluation of test-retest reliability indicated substantial to almost perfect agreement for all scores , with intraclass correlation coefficients ( 95 % confidence intervals ) ranging from .74 ( .58-.85 ) to .88 ( .8-.94 ) . For validity , Spearman 's rho correlations of Phone-FITT scores with accelerometer counts ranged from .29 ( .01-.53 ) to .57 ( .34-.73 ) . Correlations of Phone-FITT recreational scores with age and seconds to complete a self-paced step test ranged from -.29 ( -.53 to -.01 ) to -.45 ( -.68 to -.14 ) . This study contributes preliminary evidence of the reliability and validity of the Phone-FITT",
"UNLABELLED Resistance training ( RT ) is a proven sarcopenia countermeasure with a high degree of potency . However , sustainability remains a major issue that could limit the appeal of RT as a therapeutic approach without well-defined dosing requirements to maintain gains . PURPOSE To test the efficacy of two maintenance prescriptions on muscle mass , myofiber size and type distribution , and strength . We hypothesized the minimum dose required to maintain RT-induced adaptations would be greater in the old ( 60 - 75 yr ) versus young ( 20 - 35 yr ) . METHODS Seventy adults participated in a two-phase exercise trial that consisted of RT 3 d·wk for 16 wk ( phase 1 ) followed by a 32-wk period ( phase 2 ) with r and om assignment to detraining or one of two maintenance prescriptions ( reducing the dose to one-third or one-ninth of that during phase 1 ) . RESULTS Phase 1 result ed in expected gains in strength , myofiber size , and muscle mass along with the typical IIx-to-IIa shift in myofiber-type distribution . Both maintenance prescriptions preserved phase 1 muscle hypertrophy in the young but not the old . In fact , the one-third maintenance dose led to additional myofiber hypertrophy in the young . In both age groups , detraining reversed the phase 1 IIx-to-IIa myofiber-type shift , whereas a dose response was evident during maintenance training with the one-third dose better maintaining the shift . Strength gained during phase 1 was largely retained throughout detraining with only a slight reduction at the final time point . CONCLUSIONS We conclude that older adults require a higher dose of weekly loading than the young to maintain myofiber hypertrophy attained during a progressive RT program , yet gains in specific strength among older adults were well preserved and remained at or above levels of the untrained young",
"PURPOSE The 2001 Behavioral Risk Factor Surveillance System ( BRFSS ) physical activity module and the International Physical Activity Question naire ( IPAQ ) are used in population studies to determine the prevalence of physical activity . The comparability of the prevalence estimates has not been compared in U.S. adults . This study compares the physical activity prevalence estimates from the BRFSS and the IPAQ . METHODS A telephone survey was administered to a r and om sample of 11,211 U.S. adults aged 18 - 99 yr who were enrolled in the National Physical Activity and Weight Loss Survey . Data were analyzed from 9945 adults who provided complete data on the BRFSS and the IPAQ . Prevalence estimates were computed ( 1 ) applying the BRFSS scoring scheme for both question naires ( 2 ) . Kappa statistics were used to compare prevalence estimates generated from the BRFSS and the IPAQ . RESULTS When scored using the BRFSS protocol , agreement between physical activity categories was fair ( kappa = 0.34 - 0.49 ) . Prevalence estimates were higher on the IPAQ than the BRFSS for the lowest category ( inactive ) by 0.1 - 3.9 % and for the highest category ( meets recommendations ) by 0.2 - 9.7 % . When scored using their own scoring , agreement between physical activity categories was lower ( kappa = 0.26 - 0.39 ) . The prevalence estimates on the IPAQ were higher than on the BRFSS for the lowest physical activity category by 0.2 - 13.3 % and for the highest physical activity category by 0 - 16.4 % . Differences in physical activity categories were observed for sex , age , income , education , and body mass index on both question naires . CONCLUSION Because of differences in the physical activity prevalence estimates , direct comparison of the BRFSS and IPAQ prevalence estimates is not recommended"
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BACKGROUND The prevalence of diabetes mellitus is ubiquitous . Complications and costs of diabetes are rising and are depleting limited re sources . It is imperative for healthcare professionals and patients alike to confront this chronic condition by exploring new interventions . An innovative health care delivery model has emerged in the last 25 years in the form of the group medical visit . Group medical visits can range from of six to twenty patients scheduled together with time allotted for individual care as well as in the group setting . OBJECTIVES The review objective was to conduct a systematic review and meta- analysis to synthesize the best available evidence related to effectiveness of group medical visits on HbA1c , blood pressure and cholesterol measurements /levels for adult patients with type II diabetes in outpatient setting s. SEARCH STRATEGY A three-step literature search for studies in English language from 1990 to 2010 was conducted utilising ( a ) a primary search of Medline , CINAHL , PsycINFO and Cochrane Central Register of Controlled Trials , ( b ) a secondary search of non-indexed data bases , and ( c ) a search of the grey literature . In addition , a manual review of the reference lists of all identified reports and articles was performed to identify additional studies . INCLUSION CRITERIA All r and omised and quasi-experimental studies of adult patients ( > 18 ) with type II diabetes mellitus seen in outpatient health setting s were considered if they met one or more of the following diagnostic outcome measurements : haemoglobin A1c , systolic and diastolic blood pressure , and low density lipoprotein cholesterol . CRITICAL APPRAISAL , DATA COLLECTION AND ANALYSIS Each of the eligible articles was review ed by two independent review ers . Disagreements between the review ers were resolved through discussion , or with a third review er . Studies that met the inclusion criteria were assessed for method ological quality using the JBI st and ardized critical appraisal tools . Data extraction was undertaken using the st and ardised data extraction tool from JBI-MAStARI . MAIN RESULTS The search strategy identified 2,040 articles in the published and unpublished literature . Of these , 11 r and omised controlled trials and 4 quasi-experimental trials met the inclusion criteria and represented 2240 patients included in the final review .There are clear benefits of group medical visits for patients ' HbA1c levels which are consistent in the post-intervention and change from baseline effect sizes . The most significant effect observed is with the change from baseline results . Some evidence suggests post-intervention and change from baseline systolic blood pressure improvement at the nine to twelve month interval and change from baseline improvement at the 4 year timeframe . There is no evidence that group visits improve LDL cholesterol values of the group visit participants . CONCLUSIONS Group medical visits should be considered by clinicians as an effective non-pharmacologic intervention that can have a positive impact on biologic markers such as haemoglobin A1c and systolic blood pressure . IMPLICATION S FOR PRACTICE The evidence suggests that the most powerful model of Group medical visits ( GMV ) is when a clinician prescriber is present during or immediately after GMV sessions for medication reconciliation or individual patient needs . IMPLICATION S FOR RESEARCH Future research should include this GMV intervention in r and omised controlled trials across different health systems and socio-economic and ethnic groups | [
"OBJECTIVE To study time course changes in knowledge , problem solving ability , and quality of life in patients with type 2 diabetes managed by group compared with individual care and education . RESEARCH DESIGN AND METHODS We conducted a 5-year r and omized controlled clinical trial of continuing systemic education delivered by group versus individual diabetes care in a hospital-based secondary care diabetes unit . There were 120 patients with non-insulin-treated type 2 diabetes enrolled and r and omly allocated to group or individual care . Eight did not start and 28 did not complete the study . The main outcome measures were knowledge of diabetes , problem solving ability , quality of life , HbA1c , BMI , and HDL cholesterol . RESULTS Knowledge of diabetes and problem solving ability improved from year 1 with group care and worsened among control subjects ( P Quality of life improved from year 2 with group care but worsened with individual care ( P HbA1c level progressively increased over 5 years among control subjects ( + 1.7 % , 95 % CI 1.1 - 2.2 ) but not group care patients ( + 0.1 % , -0.5 to 0.4 ) , in whom BMI decreased ( -1.4 , -2.0 to -0.7 ) and HDL cholesterol increased ( + 0.14 mmol/l , 0.07 - 0.22 ) . CONCLUSIONS Adults with type 2 diabetes can acquire specific knowledge and conscious behaviors if exposed to educational procedures and setting s tailored to their needs . Traditional one-to-one care , although delivered according to optimized criteria , is associated with progressive deterioration of knowledge , problem solving ability , and quality of life . Better cognitive and psychosocial results are associated with more favorable clinical outcomes",
"Purpose The purpose of this study was to assess whether the VA-MEDIC ( Veterans Affairs Multi-disciplinary Education and Diabetes Intervention for Cardiac risk reduction ) , a pharmacist-led group medical visit program , could improve achievement of target goals in hypertension , hyperglycemia , hyperlipidemia , and tobacco use in patients with type 2 diabetes compared to usual care . Methods This was a r and omized controlled trial of VA-MEDIC intervention in addition to usual care versus usual care alone in diabetic patients to reduce cardiac risk factors . VA-MEDIC consisted of a 40- to 60-minute educational component by nurse , nutritionist , physical therapist , or pharmacist followed by pharmacist-led behavioral and pharmacological interventions over 4 weekly sessions . Measures The attainment of target goals in hemoglobin A1C ( A1C ) , blood pressure , fasting lipids , and tobacco use recommended by the American Diabetes Association . Results Of 118 participants , 109 completed the study . VA-MEDIC ( n = 58 ) participants were younger and had greater tobacco use at baseline than usual care but were similar in other cardiovascular risk factors . After 4 months , a greater proportion of VA-MEDIC participants versus controls achieved an A1C of less than 7 % and a systolic blood pressure less than 130 mm Hg . No significant change was found in lipid control or tobacco use between the 2 study arms . Conclusion Pharmacist-led group medical visits are feasible and efficacious for improving cardiac risk factors",
"Purpose The purpose of this pilot study was to evaluate a culturally tailored intervention for rural African Americans . Social Cognitive Theory provided the framework for the study . Methods Twenty-two participants were recruited and r and omly assigned to either Group or Individual diabetes self-management ( DSME ) . Group DSME included story-telling , h and s-on activities , and problem-solving exercises . Individual DSME sessions focused on goal - setting and problem-solving strategies . Sessions were offered in an accessible community center over a 10-week period . Results Outcomes included glycosylated hemoglobin ( A1C ) , self-care actions , self-efficacy level , goal attainment , and satisfaction with DSME . Participants in both Group and Individual DSME improved slightly over the 3-month period in self-care activities , A1C level , and goal attainment . Although differences were not statistically significant , trends indicate improved scores on dietary actions , foot care , goal attainment , and empowerment for those experiencing Group DSME . Conclusions The culturally tailored approach was well received by all participants . Improvements among those receiving Individual DSME may indicate that brief sessions using a culturally tailored approach could enhance self-care and glycemic control . Additional testing among more participants over a longer time period is recommended",
"Background Current guidelines recommend education , physical activity and changes in diet for type 2 diabetes patients , yet the composition and organization of non-pharmacological care are still controversial . Therefore , it is very important that programmes aim ing to improve non-pharmacological treatment of type 2 diabetes are developed and evaluated . The Copenhagen Type 2 Diabetes Rehabilitation Project aims to evaluate the effectiveness of a new group-based lifestyle rehabilitation programme in a Health Care Centre in primary care . Methods / Design The group-based diabetes rehabilitation programme consists of empowerment-based education , supervised exercise and dietary intervention . The effectiveness of this multi-disciplinary intervention is compared with conventional individual counselling in a Diabetes Outpatient Clinic and evaluated in a prospect i ve and r and omized controlled trial . During the recruitment period of 18 months 180 type 2 diabetes patients will be r and omized to the intervention group and the control group . Effects on glycaemic control , quality of life , self-rated diabetes symptoms , body composition , blood pressure , lipids , insulin resistance , beta-cell function and physical fitness will be examined after 6 , 12 and 24 months . Discussion The Copenhagen Type 2 Diabetes Rehabilitation Project evaluates a multi-disciplinary non-pharmacological intervention programme in a primary care setting and provides important information about how to organize non-pharmacological care for type 2 diabetes patients .Trail Registration Clinical Trials.gov registration number : NCT00284609",
"Aim : To verify if Group Care , a model to manage Type 2 diabetes ( T2DM ) by systemic continuing group education , can be administered by nurses and dieticians under pedagogic guidance , and improve metabolic control , quality of life , Locus of Control , and insulin resistance . Material and subjects : Twenty-five patients with non-insulin-treated T2DM were r and omized to Group Care and 24 to continued habitual individual care and education delivered by a diabetes specialist and pedagogist , respectively . Six nurses and 1 dietician received training by an accredited programme , a detailed operating manual and pedagogical supervision throughout the study . Follow-up was for 2 yr and included measurements of fasting blood glucose , glycated hemoglobin ( HbA1c ) , body mass index , waist circumference , lipids , creatinine , blood pressure , serum insulin , homeostasis model assessment ( HOMA ) index of insulin resistance , health behaviors , quality of life , state and trait anxiety , and Locus of Control . Results : One patient on Group Care and 3 controls dropped out . At the end of study , the patients on Group Care had lower HbA1c ( 7.6± 0.8 vs 8.4± 1.3 , p ) , insulin ( 18.0± 9.6 vs 24.3± 13.7 , p ( 6.9± 5.4 vs 9.2± 6.6 , p ( 17.2± 5.9 vs 24.9± 4.2 , p life ( 65.0± 11.0 vs 78.4± 19.6 , p Conclusions : Group Care delivered by trained nurses and dietitan is associated with better outcomes than those obtained by a medically and pedagogically qualified team . It may offer a model for health operators to re-organize clinical practice and for patients to improve lifestyle and strengthen the therapeutic alliance with their carers",
"OBJECTIVE To implement an educational program in 10 Latin American countries and to evaluate its effect on the clinical , biochemical , and therapeutic aspects as well as the economic cost of diabetes . RESEARCH DESIGN AND METHODS Educators from each participating country were previously trained to implement the educational model . The patient population included 446 individuals with type 2 diabetes ; all patients were Clinical and therapeutic data and the cost of their pharmacological treatment were collected 6 months before participation in the educational program ( -6 months ) , on entry into the program ( time 0 ) , and at 4 , 8 , and 12 months after initiation of the program . RESULTS All parameters measured had improved significantly ( P fasting blood glucose ( mean + /- SD ) 10.6 + /- 3.5 vs. 8.7 + /- 3.0 mmol/l ; HbA(1c ) 9.0 + /- 2.0 vs. 7.8 + /- 1.6 % ; body weight 84.6 + /- 14.7 vs. 81.2 + /- 15.2 kg ; systolic blood pressure 149.6 + /- 33.6 vs. 142.9 + /- 18.8 mmHg ; total cholesterol 6.1 + /- 1.1 vs. 5.4 + /- 1.0 mmol/l ; and triglycerides 2.7 + /- 1.8 vs. 2.1 + /- 1.2 mmol/l . At 12 months , the decrease in pharmacotherapy required for control of diabetes , hypertension , and hyperlipidemia represented a 62 % decrease in the annual cost of treatment ( $ 107,939.99 vs. $ 41,106.30 [ U.S. ] ) . After deducting the additional cost of glucosuria monitoring ( $ 30,604 ) , there was still a 34 % annual savings . CONCLUSIONS The beneficial results of this educational model , implemented in 10 Latin American countries , reinforce the value of patient education as an essential part of diabetes care . They also suggest that an educational approach promoting healthy lifestyle habits and patient empowerment is an effective strategy with the potential to decrease the development of complications related to diabetes as well as the socioeconomic costs of the disease",
"Background There is a need to identify effective practical interventions to decrease cardiovascular disease risk in patients with diabetes . Objective We examine the impact of participation in a collaborative implementing the chronic care model ( CCM ) on the reduction of cardiovascular disease risk in patients with diabetes . Design Controlled pre- and postintervention study . Patients / Participants Persons with diabetes receiving care at 13 health care organizations exposed to the CCM collaborative and controls receiving care in nonexposed sites . Measurements and Main Results Ten-year risk of cardiovascular disease ; determined using a modified United Kingdom Prospect i ve Diabetes Study risk engine score . A total number of 613 patients from CCM intervention sites and 557 patients from usual care control sites met the inclusion criteria . The baseline mean 10-year risk of cardiovascular disease was 31 % for both the intervention group and the control group . Participants in both groups had improved blood pressure , lipid levels , and HbA1c levels during the observation period . R and om intercept hierarchical regression models showed that the intervention group had a 2.1 % ( 95 % CI −3.7 % , −0.5 % ) greater reduction in predicted risk for future cardiovascular events when compared to the control group . This would result in a reduced risk of one cardiovascular disease event for every 48 patients exposed to the intervention . Conclusions Over a 1-year interval , this collaborative intervention using the CCM lowered the cardiovascular disease risk factors of patients with diabetes who were cared for in the participating organization ’s setting s. Further work could enhance the impact of this promising multifactorial intervention on cardiovascular disease risk reduction",
"The aim of this study was to evaluate the effect of a structured teaching/treatment programme on the clinical and metabolic control of non-insulin-dependent ( type 2 ) diabetic patients . The programme was aim ed at improving the overall treatment quality in these patients through measures involving self-care , diet , exercise and weight reduction . Four theoretical-practical teaching units were given once a week to group of 5–8 ambulatory patients by previously trained general practitioners . Clinical and biochemical parameters were recorded at the beginning of the course and 1 year after its completion in 40 patients attending the programme and in 39 patients of similar clinical characteristics under conventional diabetes treatment , but receiving no structured teaching before or during the survey period ( control group ) . The drop-out percentage in the intervention group ( 25 % ) was significantly lower than in the control group (45%),P were : body weight loss −2.4±0.5 kg vs −0.4±0.5 ( P ; haemoglobin HbA1 −0.2%±0.4 % vs + 0.8±0.4 % ( NS ) ; number of daily oral hypoglycaemic agent intake −1.4±0.2 vs + 0.9±0.2 tablets ( P improve the compliance and clinico-metabolic control of type 2 patients at the primary health care level",
"OBJECTIVE To evaluate the effectiveness of a managed care approach to health care delivery , group visits , in the management of uninsured or inadequately insured patients with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 120 patients with uncontrolled type 2 diabetes were r and omly assigned to receive their care in group visits or usual care for 6 months . After 6 months , concordance with 10 process-of-care indicators recommended by the American Diabetes Association ( ADA ) st and ards of care was evaluated through chart abstract ion . The 10 items evaluated were up-to- date HbA(1c ) levels and lipid profiles , urine for microalbumin , appropriate use of ACE inhibitor or angiotensin receptor blockers , use of lipid-lowering agents where indicated , daily aspirin use , annual foot examinations , annual referrals for retinal examinations , and immunizations against streptococcal pneumonia and influenza . RESULTS Patients who received care in group visits showed statistically significant improvement in concordance with these 10 process-of-care indicators ( P Group visits proved more effective in promoting concordance with ADA st and ards of care than usual care in the treatment of uninsured or inadequately insured patients with type 2 diabetes",
"OBJECTIVE To evaluate the impact of primary care group visits ( chronic care clinics ) on the process and outcome of care for diabetic patients . RESEARCH DESIGN AND METHODS We evaluated the intervention in primary care practice s r and omized to intervention and control groups in a large-staff model health maintenance organization ( HMO ) . Patients included diabetic patients > or = 30 years of age in each participating primary care practice , selected at r and om from an automated diabetes registry . Primary care practice s were r and omized within clinics to either a chronic care clinic ( intervention ) group or a usual care ( control ) group . The intervention group conducted periodic one-half day chronic care clinics for groups of approximately 8 diabetic patients in their respective doctor 's practice . Chronic care clinics consisted of st and ardized assessment s ; visits with the primary care physician , nurse , and clinical pharmacist ; and a group education/peer support meeting . We collected self-report question naires from patients and data from administrative systems . The question naires were mailed , and telephoned interviews were conducted for nonrespondents , at baseline and at 12 and 24 months ; we queried the process of care received , the satisfaction with care , and the health status of each patient . Serum cholesterol and HbA1c levels and health care use and cost data was collected from HMO administrative systems . RESULTS In an intention-to-treat analysis at 24 months , the intervention group had received significantly more recommended preventive procedures and helpful patient education . Of five primary health status indicators examined , two ( SF-36 general health and bed disability days ) were significantly better in the intervention group . Compared with control patients , intervention patients had slightly more primary care visits , but significantly fewer specialty and emergency room visits . Among intervention participants , we found consistently positive associations between the number of chronic care clinics attended and a number of outcomes , including patient satisfaction and HbA1c levels . CONCLUSIONS Periodic primary care sessions organized to meet the complex needs of diabetic patients imrproved the process of diabetes care and were associated with better outcomes",
"OBJECTIVE To determine the effects of a culturally competent diabetes self-management intervention in Mexican Americans with type 2 diabetes . RESEARCH DESIGN AND METHODS A prospect i ve , r and omized , repeated measures study was conducted on the Texas-Mexico border in Starr County . A total of 256 r and omly selected individuals with type 2 diabetes between 35 and 70 years of age , diagnosed with type 2 diabetes after 35 years of age , and accompanied by a family member or friend were included . The intervention consisted of 52 contact hours over 12 months and was provided by bilingual Mexican American nurses , dietitians , and community workers . The intervention involved 3 months of weekly instructional sessions on nutrition , self-monitoring of blood glucose , exercise , and other self-care topics and 6 months of biweekly support group sessions to promote behavior changes . The approach was culturally competent in terms of language , diet , social emphasis , family participation , and incorporation of cultural health beliefs . Outcomes included indicators of metabolic control ( HbA(1c ) and fasting blood glucose ) , diabetes knowledge , and diabetes-related health beliefs . RESULTS Experimental groups showed significantly lower levels of HbA(1c ) and fasting blood glucose at 6 and 12 months and higher diabetes knowledge scores . At 6 months , the mean HbA(1c ) of the experimental subjects was 1.4 % below the mean of the control group ; however , the mean level of the experimental subjects was still high ( > 10 % ) . CONCLUSIONS This study confirms the effectiveness of culturally competent diabetes self-management education on improving health outcomes of Mexican Americans , particularly for those individuals with HbA(1c ) levels > 10 %",
"BACKGROUND Current diabetes management guidelines offer blueprints for providers , yet type 2 diabetes control is often poor in disadvantaged population s. The group visit is a new treatment modality originating in managed care for efficient service delivery to patients with chronic health problems . Group visits offer promise for delivering care to diabetic patients , as visits are lengthier and can be more frequent , more organized , and more educational . OBJECTIVE To evaluate the effect of group visits on clinical outcomes , concordance with 10 American Diabetes Association ( ADA ) guidelines [ American Diabetes Association , Diabetes Care , 28:S4–36 , 2004 ] and 3 United States Preventive Services Task Force ( USPSTF ) cancer screens [ U.S. Preventive Services Task Force , http://www.ahrq.gov/clinic/uspstf/re source .htm , 2003 ] . RESEARCH DESIGN AND METHODS A 12-month r and omized controlled trial of 186 diabetic patients comparing care in group visits with care in the traditional patient – physician dyad . Clinical outcomes ( HbA1c , blood pressure [ BP ] , lipid profiles ) were assessed at 6 and 12 months and quality of care measures ( adherence to 10 ADA guidelines and 3 USPSTF cancer screens ) at 12 months . RESULTS At both measurement points , HbA1c , BP , and lipid levels did not differ significantly for patients attending group visits versus those in usual care . At 12 months , however , patients receiving care in group visits exhibited greater concordance with ADA process-of-care indicators ( p higher screening rates for cancers of the breast ( 80 vs. 68 % , p = .006 ) and cervix ( 80 vs 68 % , p = .019 ) . CONCLUSIONS Group visits can improve the quality of care for diabetic patients , but modifications to the content and style of group visits may be necessary to achieve improved clinical outcomes",
"OBJECTIVES The current study was conducted to compare the effectiveness of delivering diabetes education in either a group or individual setting using a consistent , evidence -based curriculum . RESEARCH DESIGN AND METHODS A total of 170 subjects with type 2 diabetes were r and omly assigned to either group ( n = 87 ) or individual ( n = 83 ) educational setting s. Subjects received education in four sequential sessions delivered at consistent time intervals over a 6-month period . Outcomes included changes in knowledge , self-management behaviors , weight , BMI , HbA(1c ) , health-related quality of life , patient attitudes , and medication regimen . Changes were assessed at baseline and after the 2-week , 3-month , and 6-month education sessions . RESULTS Both educational setting s had similar improvements in knowledge , BMI , health-related quality of life , attitudes , and all other measured indicators . HbA(1c ) decreased from 8.5 + /- 1.8 % at baseline to 6.5 + /- 0.8 % at 6 months ( P HbA(1c ) ( P HbA(1c ) ( P HbA(1c ) improvement was marginally greater in subjects assigned to group education versus individualized education ( P = 0.05 ) . CONCLUSIONS This study demonstrates that diabetes education delivered in a group setting , when compared with an individual setting , was equally effective at providing equivalent or slightly greater improvements in glycemic control . Group diabetes education was similarly effective in delivering key educational components and may allow for more efficient and cost-effective methods in the delivery of diabetes education programs",
"OBJECTIVE To evaluate the effectiveness of a cluster visit model led by a diabetes nurse educator for delivering outpatient care management to adult patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS This study involved a r and omized controlled trial among patients of Kaiser Permanente 's Pleasanton , CA , center who were aged 16 - 75 years and had either poor glycemic control ( HbA1c > 8.5 % ) or no HbA1c test performed during the previous year . Intervention subjects received multidisciplinary outpatient diabetes care management delivered by a diabetes nurse educator , a psychologist , a nutritionist , and a pharmacist in cluster visit setting s of 10 - 18 patients /month for 6 months . Outcomes included change ( from baseline ) in HbA1c levels ; self-reported changes in self-care practice s , self-efficacy , and satisfaction ; and utilization of inpatient and outpatient health care . RESULTS After the intervention , HbA1c levels declined by 1.3 % in the intervention subjects versus 0.2 % in the control subjects ( P self-care practice s and several measures of self-efficacy improved significantly in the intervention group . Satisfaction with the program was high . Both hospital ( P = 0.04 ) and outpatient ( P adults with diabetes improved glycemic control , self-efficacy , and patient satisfaction and result ed in a reduction in health care utilization after the program",
"It has been suggested that much effort expended in teaching diabetic diets is ineffective and wasteful . We have tested a different system by r and omly allocating 75 newly diagnosed obese Type 2 diabetic patients to usual ‘ unstructured ’ clinic care or to group education by diabetes specialist nurses and a dietitian . Patients allocated to group education attended five 90‐min group sessions during the first 6 months . Six months after diagnosis they had lost more weight ( median ( 95 % CI ) , 7 ( 5.5–9 ) vs 2 ( 1–5 ) kg , p were better controlled ( HbA1 : 7.5 ( 7.0–8.1 ) vs 9.5 ( 8.7–10.4 ) % , p the difference in weight loss was less ( 5.5 ( 4–6.5 ) vs 3 ( 2–4 ) kg , p had a fasting blood glucose less than 7.0 mmol l−1",
"A structured treatment and teaching programme for non-insulin-treated non-insulin-dependent ( type 2 ) diabetes was evaluated prospect ively in general practice . The four group sessions were mainly conducted by paramedical personnel . 65 patients from five general practice s were assessed at the start of the programme and 50 ( mean age 65 years , diabetes duration 7 years ) completed the 1 year follow-up ( intervention group ) . The control group consisted of 49 patients ( mean age 63 years , diabetes duration 7 years ) from three other general practice s without the programme . In the intervention group the percentage of patients receiving sulfonylureas fell from 68 % at the start of the study to 38 % after 1 year ( mean difference 30 % , 95 % confidence interval [ CI ] 16 - 44 % ) ; the mean weight loss was 2.7 kg ( 95 % CI 1.6 - 3.8 kg ) , and non-fasting triglycerides were reduced by 0.77 mmol/1 ( 95 % CI 0.35 - 1.19 mmol/l ) ; and glycosylated haemoglobin remained unchanged ( 7.1 % of total haemoglobin ) . In the control group none of these indices was changed during the study year , and 10 % of patients started insulin treatment . The structured treatment and teaching programme improved the overall quality of patient care in elderly non-insulin-dependent diabetic patients treated by general practitioners",
"Increasing dem and to deliver and document therapeutic and preventive care sharpens the need for disease management strategies that accomplish these goals efficiently while preserving quality of care . The purpose of this study was to compare selected outcomes for a new chronic disease management program involving a nurse practitioner - physician team with those of an existing model of care . One hundred fifty-seven patients with hypertension and diabetes mellitus were r and omly assigned to their primary care physician and a nurse practitioner or their primary care physician alone . Costs for personnel directly involved in patient management , calculated from hourly rates and encounter time with patients , and pre- and post- study glycosylated hemoglobin ( HbA1c ) , high-density lipoprotein cholesterol ( HDL-c ) , satisfaction with care and health-related quality of life ( HRQoL ) were assessed . Although 1-year costs for personnel were higher in the team-treated group , participants experienced significant improvements in mean HbA1c ( − 0.7 % , p = 0.02 ) and HDL-c ( + 2.6 mg dL − 1 , p = 0.02 ) . Additionally , satisfaction with care improved significantly for team-treated subjects in several sub-scales whereas the mean change over time in HRQoL did not differ significantly between groups . This study demonstrates the value of a complementary team approach to chronic disease management in improving patient-derived and clinical outcomes at modest incremental costs",
"BACKGROUND A new diabetes shared care service was introduced in North Dublin . It was design ed as a r and omized controlled trial with a complex intervention comprising education of participating practitioners , the introduction of a community-based diabetes nurse specialist , local agreement on clinical protocol s and structured communication across the primary - secondary care interface . OBJECTIVES Our aim was to assess the feasibility and effectiveness of a structured diabetes shared care service in a mixed health care system and to analyse the impact on total patient care . METHODS A Cluster r and omized controlled trial lasting 18 months was carried out in 183 patients with type 2 diabetes from 30 general practice s in North Dublin . Biophysical outcomes ( HbA1c , blood pressure , body mass index ) , psychosocial measures ( smoking status and Diabetes Clinic Treatment Satisfaction and Diabetes Well-being scores ) and process outcomes were collected . RESULTS There were significant improvements in diabetes care delivery and in psychosocial outcomes , but no significant improvements in biomedical outcomes . Process data collection revealed a significant increase in diabetes care-related activity for participating patients with an increase in structured annual review s and fewer patients defaulting from care . There were also significant improvements in information exchange between primary and secondary care . CONCLUSION Structured diabetes shared care , in a mixed health care system , can produce significant improvements in diabetes care delivery and in psychosocial outcomes for patients , with improved information exchange across the primary - secondary care interface",
"The efficacy of a treatment and teaching programme for non-insulin-treated Type 2 diabetic patients in general practice was evaluated in a prospect i ve , controlled study . In a rural area in southern Austria , 53 patients from seven general practice s participated in a structured programme ( intervention group ) and 55 patients from seven general practice s without the programme served as the control group . After 6 months the weight reduction in the intervention group was 2.6 kg ( 1.6 - 3.7 kg , p HbA1c between the groups was 0.92 % ( 0.23 - 1.61 % , p Systolic ( -16.6 mmHg ) and diastolic ( -11.1 mmHg ) blood pressure , serum triglycerides ( -0.63 mmol I-1 ) , and serum cholesterol ( -0.40 mmol I-1 ) were reduced significantly in the intervention group ( p number of patients with callus formation and poor nail care decreased significantly after participating in the teaching programme ( p reduction in body weight , metabolic control or in risk factors for diabetic foot complications were observed . Calculated health care costs per patient and year decreased in the intervention group ( -33 pounds ) and increased in the control group ( + 30 pounds ) mainly due to changes in prescription of oral hypoglycaemic agents in both groups . This programme may be an efficient and helpful model to increase overall quality of diabetes care according to the St Vincent Declaration",
"BACKGROUND Group medical clinics ( GMCs ) are widely used in the management of diabetes and hypertension , but data on their effectiveness are limited . OBJECTIVE To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00286741 ) SETTING 2 Veterans Affairs Medical Centers in North Carolina and Virginia . PATIENTS 239 patients with poorly controlled diabetes ( hemoglobin A(1c ) [ HbA(1c ) ] level > or = 7.5 % ) and hypertension ( systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg ) . INTERVENTION Patients were r and omly assigned within each center to either attend a GMC or receive usual care . Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist , a pharmacist , and a nurse or other certified diabetes educator . Each session included structured group interactions moderated by the educator . The pharmacist and physician adjusted medication to manage each patient 's HbA(1c ) level and blood pressure . MEASUREMENTS Hemoglobin A(1c ) level and systolic blood pressure , measured by blinded research personnel at baseline , study midpoint ( median , 6.8 months ) , and study completion ( median follow-up , 12.8 months ) . Linear mixed models , adjusted for clustering within GMCs , were used to compare HbA(1c ) levels and systolic blood pressure between the intervention and control groups . RESULTS Mean baseline systolic blood pressure and HbA(1c ) level were 152.9 mm Hg ( SD , 14.2 ) and 9.2 % ( SD , 1.4 ) , respectively . At the end of the study , mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group ( P = 0.011 by linear mixed model ) , whereas mean HbA(1c ) level improved by 0.8 % in the GMC group and 0.5 % in the usual care group ( P = 0.159 ) . LIMITATION Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention . CONCLUSION Group medical clinics are a potent strategy for improving blood pressure but not HbA(1c ) level in diabetic patients . PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs Health Services Research and Development Service",
"OBJECTIVE To evaluate whether attending diabetes group visits ( GVs ) leads to lower medical care charges for inadequately insured patients with type 2 diabetes mellitus ( DM ) . STUDY DESIGN R and omized controlled clinical trial . METHODS Data were abstract ed from financial records for 186 patients with uncontrolled type 2 DM r and omized to receive care in GVs or usual care for 12 months . Mann-Whitney tests for differences of means for outpatient visits ( primary and specialty care ) , emergency department ( ED ) visits , and inpatient stays were performed . Separate charge models were developed for primary and specialty outpatient visits . Because GV adherence is potentially dependent on unobserved patient characteristics , treatment effect models of outpatient charges and specialty care visits were estimated using maximum likelihood methods . RESULTS Mann-Whitney test results indicated that GV patients had reduced ED and total charges but more outpatient charges than usual care patients . Ordinary least squares estimations confirmed that GVs increased outpatient visit charges ; however , controlling for endogeneity by estimating a treatment effect model of outpatient visit charges showed that GVs statistically significantly reduced outpatient charges ( P GV effects on outpatient visit charges occurred via a reduction in specialty care visits . CONCLUSIONS After controlling for endogeneity via estimation of a treatment effect model , GVs statistically significantly reduced outpatient visit charges . Estimation of a separate treatment effect model of specialty care visits indicated that GVs likely substitute for more expensive specialty care visits",
"To evaluate group visits in the management of underinsured patients with uncontrolled type 2 diabetes , 120 eligible patients enrolled were r and omly assigned to receive care in groups or continue usual care . Feasibility , acceptability , and concordance with American Diabetes Association st and ards of care ( Diab Camre . 25[suppl 1]:533 - 549 ) were evaluated . Patients who received care in groups exhibited improvement in American Diabetes Association st and ards of care ( p improved sense of trust in physician ( p = .02 ) , and tended to report better coordination of care ( p = .07 ) , better community orientation ( p = .09 ) , and more culturally competent care ( p = .09 ) . Group visits offer a promising model for delivering health care to these patients",
"AIM The purpose of this study was to examine the effect of the diabetes outpatient intensive management programme ( DOIMP ) on glycaemic control over a 12 week follow-up period for type 2 diabetic patients in Korea . BACKGROUND Diabetic complications can be prevented if the glycaemic status of diabetes patients is maintained within a nearly normal range . Patient education is critical in controlling blood glucose levels of patients with diabetes within the optimal range . METHODS DOIMP was composed of multidisciplinary education , complication monitoring and telephone counselling . Twenty-five patients in the intervention group participated in the DOIMP and 24 patients in the control group were briefed on the conventional description of diabetes mellitus by diabetes education nurses . RESULTS Patients in the intervention group had a mean decrease of 2.3 % , which those in the control group having a mean decrease 0.4 % in glycosylated haemoglobin ( HbA(1)c ) . There was no difference between the two groups in the change in fasting blood glucose ( FBG ) and two-hour postpr and ial blood glucose ( 2-h PBG ) . The proportion of the patients with HbA(1)c was higher in the intervention group than in the control group at the post-test compare with the pretest . CONCLUSION DOIMP can reduce HbA(1)c in type 2 diabetes patients . RELEVANCE TO CLINICAL PRACTICE These findings indicated that DOIMP could be effective in glycaemic control in type 2 diabetes patients",
"Objective : The epidemic proportions and management complexity of diabetes have prompted efforts to improve clinic throughput and efficiency . One method of system re design based on the chronic care model is the Shared Medical Appointment ( SMA ) in which groups of patients ( 8–20 ) are seen by a multi-disciplinary team in a 1–2 h appointment . Evaluation of the impact of SMAs on quality of care has been limited . The purpose of this quality improvement project was to improve intermediate outcome measures for diabetes ( A1c , SBP , LDL-cholesterol ) focusing on those patients at highest cardiovascular risk . Setting : Primary care clinic at a tertiary care academic medical center . Subjects : Patients with diabetes with one or more of the following : A1c > 9 % , SBP blood pressure > 160 mm Hg and LDL-c > 130 mg/dl were targeted for potential participation ; other patients were referred by their primary care providers . Patients participated in at least one SMA from 4/05 to 9/05 . Study design : Quasi-experimental with concurrent , but non-r and omised controls ( patients who participated in SMAs from 5/06 through 8/06 ; a retrospective period of observation prior to their SMA participation was used ) . Intervention : SMA system re design Analytical methods : Paired and independent t tests , χ2 tests and Fisher Exact tests . Results : Each group had up to 8 patients . Patients participated in 1–7 visits . At the initial visit , 83.3 % had A1c levels > 9 % , 30.6 % had LDL-cholesterol levels > 130 mg/dl , and 34.1 % had SBP ⩾160 mm Hg . Levels of A1c , LDL-c and SBP all fell significantly postintervention with a mean ( 95 % CI ) decrease of A1c 1.4 ( 0.8 , 2.1 ) ( p ) , LDL-c 14.8 ( 2.3 , 27.4 ) ( p = 0.022 ) and SBP 16.0 ( 9.7 , 22.3 ) ( p The reductions in A1c in % and SBP were greater in the intervention group relative to the control group : 1.44 vs –0.30 ( p = 0.002 ) for A1c and 14.83 vs 2.54 mm Hg ( p = 0.04 ) for SBP . LDL-c reduction was also greater in the intervention group , 16.0 vs 5.37 mg/dl , but the difference was not statistically significant ( p = 0.29 ) . Conclusions : We were able to initiate a programme of group visits in which participants achieved benefits in terms of cardiovascular risk reduction . Some barriers needed to be addressed , and the operations of SMAs evolved over time . Shared medical appointments for diabetes constitute a practical system re design that may help to improve quality of care",
"OBJECTIVE in an academic family practice clinic , we performed a controlled trial of a multifaceted intervention versus usual care for managing diabetes . Providers received didactic training and computerized compliance feedback to support staged diabetes management , an evidence d-based approach to diabetes care . RESEARCH DESIGN AND METHODS one firm of the clinic practice received the intervention , the other served as the control group during a 14-month baseline period and a 14-month study period . HbA1(c ) was the principal outcome measure . RESULTS there was a significant 0.71 % difference in change in HbA1(c ) values between the intervention and control firms ( P=0.02 ) . The subgroup with the greatest improvement in HbA1(c ) was those subjects who started the intervention with a HbA1(c ) above 8 % . The overall improvement in glycemic control could not be explained by differences in visit frequency or the aggressiveness of drug therapy . There were no changes in healthcare utilization or costs between the two firms . CONCLUSION in an academic family practice clinic , a multifaceted intervention in support of diabetes treatment guidelines modestly improved glycemic control without incurring additional costs . The improvement was mostly due to mitigation of the natural deterioration in control usually seen . Further efforts are required to involve all patients in co-managing their diabetes",
"AIMS Scarcity of re sources , expertise and evidence -based models have so far limited delivery of patient-centred diabetes education . We have developed and vali date d a group care approach that is applicable to everyday clinical practice and cost-effective in improving metabolic control , knowledge of diabetes , health behaviours , and quality of life in Type 2 diabetes . A clinical trial ( ROMEO ) was planned to evaluate applicability and reproducibility of group care in other out patients facilities and assess its impact on a larger patient population . METHODS Multicentre , r and omized , controlled clinical trial of group vs. individual care in the routine management of Type 2 diabetes . Nine hundred patient aged or = 1 year known duration , treated by either diet alone or diet and oral agents , will be recruited in 15 centres and followed for 4 years . Training of physicians , nurses and dietitians included preparation of operating manual and videos , interactive sessions , and evaluation of local facilities and re sources . RESULTS PRIMARY MEASUREMENTS 3-monthly HbA1c , fasting blood glucose , body weight , waist-hip ratio , yearly blood lipids , and bi-yearly assessment of knowledge of diabetes , health behaviours and quality of life . SECONDARY OUTCOMES systolic and diastolic blood pressure , evaluation of ECG for ischaemia and QT interval , hypoglycaemic and anti-hypertensive medication and cardiovascular events . Analysis will be by intention-to-treat . DISCUSSION If ROMEO confirms that group care can be successfully implemented in different clinics , a novel clinico-pedagogic tool will have been acquired to support patient-centred education , improve lifestyle and outcomes , support team work , enhance providers ' attitudes and competencies and ameliorate diabetes care organization",
"Abstract Aims /hypothesis . Metabolic control worsens progressively in Type II ( non-insulin-dependent ) diabetes mellitus despite intensified pharmacological treatment and lifestyle intervention , when these are implemented on a one-to-one basis . We compared traditional individual diabetes care with a model in which routine follow-up is managed by interactive group visits while individual consultations are reserved for emerging medical problems and yearly checks for complications . Methods . A r and omized controlled clinical trial of 56 patients with non-insulin-treated Type II diabetes managed by systemic group education and 56 control patients managed by individual consultations and education . Results . Observation times were 51.2±2.1 months for group care and 51.2±1.8 for control subjects . Glycated haemoglobin increased in the control group but not in the group of patients ( p whom BMI decreased ( p and HDL-cholesterol increased ( p ) . Quality of life , knowledge of diabetes and health behaviours improved with group care ( p . Dosage of hypoglycaemic agents decreased ( p retinopathy progressed less ( p subjects . Diastolic blood pressure ( p and relative cardiovascular risk ( p the quality of life score . Conclusion /interpretation . Group care by systemic education is feasible in an ordinary diabetes clinic and cost-effective in preventing the deterioration of metabolic control and quality of life in Type II diabetes without increasing pharmacological treatment",
"AIM Central serotoninergic activity may modulate glucose metabolism via neuroendocrine effectors . Group Care is a clinico-pedagogic intervention that improves metabolic control and quality of life in Type 2 diabetes through lifestyle modification and , possibly , central mechanisms . The hypothesis that central serotoninergic activity is modified in patients followed by Group Care was tested by measuring their hypothalamic- pituitary-adrenal response to citalopram , a selective serotonin reuptake inhibitor . METHODS AND SUBJECTS Ten healthy controls and 17 non-obese , non-insulin-treated patients with Type 2 diabetes received , in r and om order , iv infusions of either 20 mg citalopram or saline . Nine patients had been longterm on Group Care and 8 had always been on traditional one-to-one care . Circulating glucose , insulin , ACTH , cortisol , DHEA , GH and PRL were measured every 15 min for 240 min . Differences between areas under the curves after citalopram and saline ( Δ-AUC ) were calculated . RESULTS Citalopram stimulated ACTH and cortisol secretion in healthy subjects ( p=0.026 and p=0.011 , respectively ) and patients on Group Care ( p=0.056 and p=0.038 ) but not in patients on traditional care . In healthy subjects , basal glucose correlated with growth hormone Δ- AUC ( r=0.820 ; p=0.004 ) and inversely with insulin Δ-AUC ( r=-0.822 ; p=0.003 ) . The former correlation was preserved in the patients ( r=0.637 ; p=0.026 ) . CONCLUSIONS Diabetes may blunt the response of the hypothalamic-pituitary-adrenal axis to citalopram , but this is preserved in patients followed by a long-term intervention model that improves clinical as well as cognitive and emotional variables",
"Hmong refugees with type 2 diabetes mellitus ( DM2 ) have poor glycemic control . For Hmong adults with DM2 , group visits were instituted at a community health center and evaluated for their influence on diabetes management . Pre- and postintervention measures of physical health , mental health , and behavior were collected on 39 participants ( 64 % participation rate ) . Baseline characteristics and clinical outcomes of 39 group visit participants were compared with 22 Hmong DM2 adults who refused to participate and 216 nonparticipating Hmong DM2 adults from a local diabetes registry . Baseline characteristics were similar among the three groups . Although participants received good medical services and their mental health improved ( p clinical outcomes did not significantly improve . Although group visits are feasible for providing medical services for Hmong adults with DM2 , clinical outcomes remain outside of recommended targets . Addressing mental health in this population may be necessary before people can institute behavioral changes that improve diabetes management",
"Recently , investigators have combined formally the results of all available r and omized trials testing a particular therapy to get a better estimate of the effectiveness of that treatment than any single trial can provide in isolation . It seems intuitively clear , however , that formal overviews will yield medically meaningful results only under certain defined circumstances . First , the treatments that are pooled should be similar enough that any inferences about the effect of treatment will refer to something more specific than an idealized ' average therapy ' . Second , patient selection in the pooled trials should be uniform enough that the inferences will be applicable to some defined patient population . Third , although the potential biases of excluding trials from pooling are substantial , so are the problems of including trials whose execution might be flawed in a biased manner ; it is not clear what can be done about this , since biased studies probably can not be identified in an unambiguous manner . Finally , it would seem prudent to consider the medical context during which trials were performed ; it is probably not reasonable to assume that quantitative measures of treatment effect obtained by pooling studies from different eras of treatment will be an accurate reflection of what current treatment can achieve , even if everything else is held constant . For these reasons the quantitative measures of treatment effect that derive from formal overviews may have little relevance to medical decision-making . Overviews might still be useful in indicating the general direction of a treatment effect , provided that no qualitative interactions are present . Although such interactions may seem improbable , some recent examples from the cancer literature suggest that their presence can not be ruled out a priori",
"OBJECTIVE A trial was performed to establish whether our group care model for lifestyle intervention in type 2 diabetes can be exported to other clinics . RESEARCH DESIGN AND METHODS This study was a 4-year , two-armed , multicenter controlled trial in 13 hospital-based diabetes clinics in Italy ( current controlled trials no. IS RCT N19509463 ) . A total of 815 non – insulin-treated patients aged were r and omized to either group or individual care . RESULTS After 4 years , patients in group care had lower A1C , total cholesterol , LDL cholesterol , triglycerides , systolic and diastolic blood pressure , BMI , and serum creatinine and higher HDL cholesterol ( P prescriptions . Health behaviors , quality of life , and knowledge of diabetes had become better in group care patients than in control subjects ( P < 0.001 , for all ) . CONCLUSIONS The favorable clinical , cognitive , and psychological outcomes of group care can be reproduced in different clinical setting",
"Purpose To improve the care and outcomes of adult patients with type 2 diabetes by teaching interprofessional teams of learners the principles and practice s of the Improving Chronic Illness Care Model . Method The study population consisted of 384 adult patients with type 2 diabetes . The study design was a nonr and omized , parallel-group , clinical trial conducted during 18 months in the University of California , San Francisco internal medicine clinics . Interprofessional team care provided by primary care internal medicine residents , nurse practitioner students , and pharmacy students was compared with usual care by internal medicine residents only . Processes of care , clinical status , and health utilization were measured in both patient groups . Learner outcomes also were assessed and compared . Results At study completion , intervention patients more frequently received assessment s of glycosolated hemoglobin ( 79 % versus 67 % ; P = .01 ) , LDL-C ( 69 % versus 55 % ; P = .009 ) , blood pressure ( 86 % versus 79 % ; P = .08 ) , microalbuminuria ( 40 % versus 30 % ; P = .05 ) , smoking status assessment ( 43 % versus 31 % ; P = .02 ) , and foot exams ( 38 % versus 20 % ; P = .0005 ) . Intervention patients had more planned general medicine visits ( 7.9 ± 6.2 versus 6.2 ± 5.7 ; P = .006 ) than did control patients . Interprofessional learners rated themselves significantly higher on measures of accomplishment , preparation , and success for chronic care than did the usual care learners . Conclusions Interprofessional team care by learners was effective in improving quality of care for adult patients with diabetes treated in general medicine clinics . The chronic illness framework result ed in more appropriate health care utilization",
"OBJECTIVE To estimate the incremental cost-effectiveness of improving diabetes care with the Health Disparities Collaborative ( HDC ) , a national collaborative quality improvement ( QI ) program conducted in community health centers ( HCs ) . DATA SOURCES / STUDY SETTING Data regarding the impact of the Diabetes HDC program came from a serial cross-sectional follow-up study ( 1998 , 2000 , 2002 ) of the program in 17 Midwestern HCs . Data inputs for the simulation model of diabetes came from the latest clinical trials and epidemiological studies . STUDY DESIGN We conducted a societal cost-effectiveness analysis , incorporating data from QI program evaluation into a Monte Carlo simulation model of diabetes . DATA COLLECTION / EXTRACTION METHODS Data on diabetes care processes and risk factor levels were extracted from medical charts of r and omly selected patients . PRINCIPAL FINDINGS From 1998 to 2002 , multiple processes of care ( e.g. , glycosylated hemoglobin testing [ HbA1C ] [ 71 - ->92 percent ] and ACE inhibitor prescribing [ 33 - ->55 percent ] ) and risk factor levels ( e.g. , 1998 mean HbA1C 8.53 percent , mean difference 0.45 percent [ 95 percent confidence intervals -0.72 , -0.17 ] ) improved significantly . With these improvements , the HDC was estimated to reduce the lifetime incidence of blindness ( 17 - ->15 percent ) , end-stage renal disease ( 18 - ->15 percent ) , and coronary artery disease ( 28 - ->24 percent ) . The average improvement in quality -adjusted life year ( QALY ) was 0.35 and the incremental cost-effectiveness ratio was $ 33,386/QALY . CONCLUSIONS During the first 4 years of the HDC , multiple improvements in diabetes care were observed . If these improvements are maintained or enhanced over the lifetime of patients , the HDC program will be cost-effective for society based on traditionally accepted thresholds"
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BACKGROUND The cost of the implant as part of a total knee arthroplasty accounts for a substantial portion of the costs for the overall procedure : all-polyethylene tibial components cost considerably less than cemented metal-backed tibial components . We performed a systematic review of the literature to determine whether the clinical results of lower-cost all-polyethylene tibial components were comparable with the results of a more expensive metal-backed tibial component . METHODS We search ed The Cochrane Library , MEDLINE , EMBASE , EBSCO CINAHL , the bibliographies of identified articles , orthopaedic meeting abstract s , health technology assessment web sites , and important orthopaedic journals . This search was performed for the years 1990 to the present . No language restriction was applied . We restricted our search to Level-I studies involving participants who received either an all-polyethylene or a metal-backed tibial implant . The primary outcome measures were durability , function , and adverse events . Two review ers independently screened the papers for inclusion , assessed trial quality , and extracted data . Effects estimates were pooled with use of fixed and r and om-effects models of risk ratios , calculated with 95 % confidence intervals . Heterogeneity was assessed with the I2 statistic . Forest plots were also generated . RESULTS Data on 1798 primary total knee implants from twelve studies were analyzed . In all studies , the median or mean age of the participants was greater than sixty-seven years , with a majority of the patients being female . There was no difference between patients managed with an all-polyethylene tibial component and those managed with a metal-backed tibial component in terms of adverse events . There was no significant difference between the two groups in terms of the durability of the implants at two , ten , and fifteen years postoperatively , regardless of the year or how durability was defined ( revision or radiographic failure ) . Finally , with use of a variety of vali date d measures , there was no difference between the two groups in terms of functional status at two , eight , and ten years , regardless of the measure used . CONCLUSION A less expensive all-polyethylene component as part of a total knee arthroplasty has results equivalent to those obtained with a cemented metal-backed tibial component . Using a total knee implant with a cemented all-polyethylene tibial component could save the healthcare system substantial money while obtaining equivalent results to more expensive cemented design s and material | [
"A prospect i ve , r and omized , double-blind trial was carried out to compare cruciate-retaining ( CR ) and posterior-stabilized ( PS ) total knee arthroplasties ( TKAs ) . A total of 40 knees were r and omized to receive either a NexGen CR ( Zimmer , Warsaw , IN ) or a Legacy PS ( Zimmer , Warsaw , IN ) TKA . All knees were implanted with identical surgical technique , making sure to balance precisely the flexion-extension gaps before implantation of the components . At 2-year follow-up , there was no difference between the CR and the PS TKAs with respect to their Knee Society clinical , functional , and radiographic scores . These findings suggest that with careful attention to surgical technique and balancing the knee , orthopaedic surgeons should expect similar results whether they use a CR or PS TKA",
"Early implants for total knee replacement were fixed to bone with cement . No firm scientific reason has been given for the introduction of cementless knee replacement and the long-term survivorship of such implants has not shown any advantage over cemented forms . In a r and omised , prospect i ve study we have compared cemented and uncemented total knee replacement and report the results of 139 prostheses at five years . Outcome was assessed both clinical ly by independent examination using the Nottingham knee score and radiologically using the Knee Society scoring system . Independent statistical analysis of the data showed no significant difference between cemented and cementless fixation for pain , mobility or movement . There was no difference in the radiological alignment at five years , but there was a notable disparity in the radiolucent line score . With cemented fixation there was a significantly greater number of radiolucent lines on anteroposterior radiographs of the tibia and lateral radiographs of the femur . At five years , our clinical results would not support the use of the more expensive cementless fixation whereas the radiological results are of unknown significance . Longer follow-up will determine any changes in the results and conclusions",
"Background The question whether the tibial component of a total knee arthroplasty should be fixed to bone with or without bone cement has not yet been definitely answered . We studied movements between the tibial component and bone by radiostereometry ( RSA ) in total knee replacement ( TKR ) for 3 different types of fixation : cemented fixation ( C-F ) , uncemented porous fixation ( UC-F ) and uncemented porous hydroxyapatite fixation ( UCHA-F ) . Patients 116 patients with osteoarthrosis , who had 146 TKRs , were included in 2 r and omized series . The first series included 86 unilateral TKRs stratified into 1 of the 3 types of fixation . The second series included 30 patients who had simultaneous bilateral TKR surgery , and who were stratified into 3 subgroups of pairwise comparisons of the 3 types of fixation . Results After 5 years 2 knees had been revised , neither of which were due to loosening . 1 UCHA-F knee in the unilateral series showed a large and continuous migration and a poor clinical result , and is a pending failure . The C-F knees rotated and migrated less than UC-F and UCHA-F knees over 5 years . UCHA-F migrated less than UC-F after 1 year . Interpretation Cementing of the tibial component offers more stable bone-implant contact for 5 years compared to uncemented fixation . When using uncemented components , however , there is evidence that augmenting a porous surface with hydroxyapatite may mean less motion between implant and bone after the initial postoperative year",
"We report the long-term survival of a prospect i ve r and omised consecutive series of 501 primary knee replacements using the press-fit condylar posterior cruciate ligament-retaining prosthesis . Patients received either cemented ( 219 patients , 277 implants ) or cementless ( 177 patients , 224 implants ) fixation . Altogether , 44 of 501 knees ( 8.8 % ) underwent revision surgery ( 24 cemented vs 20 cementless ) . For cemented knees the 15-year survival rate was 80.7 % ( 95 % confidence interval ( CI ) 71.5 to 87.4 ) and for cementless knees it was 75.3 % ( 95 % CI 63.5 to 84.3 ) . There was no significant difference between the two groups ( cemented vs cementless ; hazard ratio ( HR ) 0.83 , 95 % CI 0.45 to 1.52 , p = 0.55 ) . When comparing the covariates there was no significant difference in the rates of survival between the side of operation ( HR 0.58 , p = 0.07 ) , age ( HR 0.97 , p = 0.10 ) and diagnosis ( HR 1.25 p = 0.72 ) . However , there was a significant gender difference , with males having a higher failure rate with cemented fixation ( HR 2.48 , p = 0.004 ) . Females had a similar failure rate in both groups . This single-surgeon series , with no loss to follow-up , provides reliable data of the revision rates of one of the most commonly-used total knee replacements . The survival of the press-fit condylar total knee replacement remained good at 15 years , irrespective of the method of fixation",
"The aim of this study was to determine whether there is a difference in functional outcome between the PFC Sigma fixed-bearing and rotating-platform total knee replacement systems . One hundred twenty patients were r and omised to receive either a fixed-bearing or rotating-platform PFC Sigma total knee replacement . Range of movement ( ROM ) , Oxford knee score ( OKS ) and Knee Society score ( KSS ) were assessed independently before and one year after surgery . Weight-bearing X-rays were taken immediately and one year post surgery to determine the incidence of osteolysis and loosening . At a mean follow-up of 13.4 months there was no statistically significant difference in mean ROM , OKS and KSS between the two groups . There was no evidence of osteolysis or loosening in either of the groups and no revision for infection or implant failure . This study shows that there is no statistically significant difference in functional outcome between the two types of implants at short-term follow-up",
"PURPOSE OF THE STUDY We performed a prospect i ve r and omized study to compare two fixation modes , with and without cement , for total knee arthroplasty . MATERIAL AND METHODS The study series was composed of 96 cemented or noncemented total knee arthroplasties performed between May 1993 and October 1995 . The only difference was the diamond interface used for cemented prostheses and the mesh interface used for uncemented prostheses . The operator was unaware of the type of fixation until the bone slices had been obtained . We assessed outcome in 73 cases with a mean follow-up of 27 months . The two population s were comparable for preoperative clinical status , bone tophicity and surgical procedure . RESULTS The mean duration of the operation was sgnificantly longer ( > 10 min ) for the cemented protheses . The complication rates were comparable but we did have two mobilizations of the tibial implant in the noncemented group . The total scores ( 127 + /- 29 in the cemented group versus 135 + /- 20 in the uncemented group ) were significantly different . There were however more cases with degradation of the controlateral knee in the cemented group although the difference was not significant . When these cases were excluded from the analysis , the total scores for two groups were similar ( 143 and 140 respectively ) . Radiographic outcome was quite different with mobilization of the tibial implant in 2 cases and the rate of lucent borders was significantly higher in the noncemented group . DISCUSSION AND CONCLUSION While the clinical outcome was comparable , the quality of the fixation was significantly better with cemented arthroplasty , which remains the gold st and ard",
"We have carried out a long-term survival analysis of a prospect i ve , r and omised trial comparing cemented with cementless fixation of press-fit condylar primary total knee replacements . A consecutive series of 501 replacements received either cemented ( 219 patients , 277 implants ) or cementless ( 177 patients , 224 implants ) fixation . The patients were contacted at a mean follow-up of 7.4 years ( 2.7 to 13.0 ) to establish the rate of survival of the implant . The ten-year survival was compared using life-table and Cox 's proportional hazard analysis . No patient was lost to follow-up . The survival at ten years was 95.3 % ( 95 % CI 90.3 to 97.8 ) and 95.6 % ( 95 % CI 89.5 to 98.2 ) in the cemented and cementless groups , respectively . The hazard ratio for failure in cemented compared with cementless prostheses was 0.97 ( 95 % CI 0.36 to 2.6 ) . A comparison of the clinical outcome at ten years in 80 knees showed no difference between the two groups . The survival of the press-fit condylar total knee replacement at ten years is good irrespective of the method of fixation and brings into question the use of more expensive cementless implants",
"Fixation of the tibial component in total knee arthroplasty in younger patients remains controversial . We evaluate the results of three different types of fixation of the Profix total knee arthroplasty in a r and omized controlled trial of 97 consecutive knees ( 85 patients ) with osteoarthrosis or inflammatory arthritis with 2-year followup of all patients . We r and omized patients to three different types of fixation of the tibial component : cemented , uncemented ( HA coated ) with screws , or uncemented ( HA coated ) without screws . We performed clinical evaluations and radiostereometric analysis at 6 weeks , and 3 , 6 , 12 and 24 months postoperatively . The knees in the uncemented groups migrated more than those in the cemented group during the first 3 months , but at 2 years we observed no differences . The uncemented implants displayed all migration within the first 3 months . The cemented implants did not stabilize but had continuously increasing migration during the followup . Cementless implants without screws did not migrate more than implants with screws and displayed similar pattern of migration , indicating screws do not improve fixation . Uncemented fixation using hydroxyapatite-coated implants without screws seems to be the best solution for the younger patient . Level of Evidence : Therapeutic Level I. See the Guidelines for Authors for a complete description of levels of evidence",
"We compared patient-reported outcomes of the Kinemax fixed- and mobile-bearing total knee replacement in a multi-centre r and omised controlled trial . Patients were r and omised to the fixed- or the mobile-bearing prosthesis via a sealed envelope method after the bone cuts had been made in the operating theatre . R and omisation was stratified by centre and diagnosis . Patients were assessed pre-operatively and at eight to 12 weeks , one year and two years post-operatively . Vali date d question naires were used which included the Western Ontario MacMasters University , Short-Form 12 , Mental Health Index-5 , Knee Injury and Osteoarthritis Outcome Score for Knee-Related Quality of Life and Function in Sport and Recreation scales and a vali date d scale of satisfaction post-operatively . In total , 242 patients ( 250 knees ) with a mean age of 68 years ( 40 to 80 ) were recruited from four NHS orthopaedic centres . Of these , 132 patients ( 54.5 % ) were women . No statistically significant differences could be identified in any of the patient-reported outcome scores between patients who received the fixed-bearing or the mobile-bearing knee up to two-years post-operatively",
"A prospect i ve , r and omized , double-blind study was performed to evaluate three different means of fixing tibial components during total knee arthroplasty . Eleven components fixed with cement , ten hydroxyapatite-coated components fixed without cement , and ten noncoated components fixed without cement were studied . A posterior cruciate ligament-retaining total condylar implant was used . Micromotion of the components was assessed with roentgen stereophotogrammetric analysis during the two-year follow-up period . There were no significant differences among the patients with regard to age ( mean [ and st and ard deviation ] , 68 ± 11.6 years ) , body-mass index ( mean , 23 ± 2.8 kilograms per square meter ) , or stage of osteoarthrosis ( mean , 4 ± 2.4 according to the classification system of Ahlbäck and 5 ± 0.6 according to that of Larsen et al. ) . The diagnosis was osteoarthrosis in five knees , and it was rheumatoid arthritis in twenty-six . The clinical scores were similar among the study groups . According to the system of the Knee Society , the mean preoperative functional score was 10 ± 2.9 points and the mean preoperative knee score was 24 ± 3.2 points . At the two-year follow-up evaluation , these scores were 41 ± 8.3 and 79 ± 3.2 points , respectively . A significant difference with regard to micromotion was found between the noncoated components fixed without cement and the hydroxyapatite-coated components fixed without cement as well as between the noncoated components fixed without cement and the components fixed with cement ( p The hydroxyapatite-coated components fixed without cement and the components fixed with cement both had far less micromotion along the longitudinal axis ( subsidence ) throughout the follow-up period than did the noncoated components fixed without cement . At the two-year follow-up evaluation , the subsidence of the noncoated components was -0.73 ± 0.924 millimeter , the subsidence of the cemented components was -0.05 ± 0.109 millimeter , and the subsidence of the hydroxyapatite-coated components was -0.06 ± 0.169 millimeter . The cemented components as well as the hydroxyapatite-coated components also had less translation along the transverse axis ( p micromotion of hydroxyapatite-coated tibial components fixed without cement was similar to that of tibial components fixed with cement . Therefore , hydroxyapatite , a biological mediator , may be necessary for the adequate fixation of tibial components when cement is not used",
"Fifty-three consecutive patients ( 57 knees ; mean age , 69 years ) entered a prospect i ve r and omized study to compare the fixation of hydroxyapatite (HA)-coated ( 29 knees ) with cemented ( 28 knees ) tibial components in the Tricon II total knee arthroplasty . The quality of the fixation during 5 years postoperatively was evaluated with radiostereometric analysis ( RSA ) . Three HA-coated implants were revised : 2 owing to infection , and 1 owing to early delamination of the coating and clinical loosening . Eight patients ( 9 knees ) died , 1 patient sustained a stroke , and 1 patient refused investigations after 1 year . In the 40 patients ( 19 HA-coated , 21 cemented ) remaining at 5 years , the magnitude of the micromotion between the HA-coated and cemented groups did not differ . The HA-coated implants displayed most of the migration within the initial 3 months then stabilized , whereas the cemented implants showed an initially lower , but over time continuously increasing migration . Between 1 and 2 years , 4 of 24 HA-coated and 10 of 23 cemented implants migrated > 0.2 mm and were categorized unstable , which has been shown to have a prognostic value as regards future aseptic loosening . Progressive radiolucent lines developed in 2 cemented knees , which both were categorized unstable . If HA-coated implants can sustain the forces that threaten the fixation in the early period after implantation , a strong and enduring fixation may be obtained",
"The purpose of this prospect i ve r and omized study was to compare the postoperative recovery and early results of 2 groups of patients undergoing total knee arthroplasty : 107 patients received an established fixed-bearing posterior-stabilized prosthesis ( Legacy Posterior Stabilized [ LPS ] ) , and 103 patients the meniscal-bearing prosthesis ( Meniscal Bearing Knee [ MBK ] ) . Surgical procedures were the same for both groups except for posterior cruciate ligament management , which was sacrificed in the LPS group and spared but completely released from the tibia in the MBK group . At an average follow-up of 36 months , knee , function , and patellar scores were comparable in both groups . The LPS group showed a significantly higher maximum flexion than the MBK group ( 112 degrees vs 108 degrees ) . Using a fixed-bearing or a mobile-bearing design did not seem to influence the short-term recovery and early results after knee arthroplasty . Key words : total knee arthroplasty , mobile bearing , knee prosthesis , meniscal-bearing knee , posterior stabilized , prospect i ve r and omized",
"BACKGROUND The aim of continued development of total knee replacement systems has been the further improvement of the quality of life and increasing the duration of prosthetic survival . Our goal was to evaluate the effects of several design features , including metal backing of the tibial component , patellar resurfacing , and a mobile bearing between the tibial and femoral components , on the function and survival of the implant . METHODS A pragmatic , multicenter , r and omized , controlled trial involving 116 surgeons in thirty-four centers in the United Kingdom was performed ; 2352 participants were r and omly allocated to be treated with or without a metal backing of the tibial component ( 409 ) , with or without patellar resurfacing ( 1715 ) , and /or with or without a mobile bearing ( 539 ) . R and omization to more than one comparison was allowed . The primary outcome measures were the Oxford Knee Score ( OKS ) , Short Form-12 , EuroQol-5D , and the need for additional surgery . The results up to two years postoperatively are reported . RESULTS Functional status and quality -of-life scores were low at baseline but improved markedly across all trial groups following knee replacement ( mean overall OKS , 17.98 points at baseline and 34.82 points at two years ) . Most of the change was observed at three months after the surgery . Six percent of the patients had additional knee surgery within two years . There was no evidence of differences in clinical , functional , or quality -of-life measures between the r and omized groups at two years . CONCLUSIONS Patients have substantial improvement following total knee replacement . This is the first adequately powered r and omized controlled trial , of which we are aware , in which the effects of metal backing , patellar resurfacing , and a mobile bearing were investigated . We found no evidence of an effect of these variants on the rate of early complications or on functional recovery up to two years after total knee replacement",
"BACKGROUND AND PURPOSE The purpose of this study was to assess the reliability , construct validity , and sensitivity to change of the Lower Extremity Functional Scale ( LEFS ) . SUBJECTS AND METHODS The LEFS was administered to 107 patients with lower-extremity musculoskeletal dysfunction referred to 12 outpatient physical therapy clinics . METHODS The LEFS was administered during the initial assessment , 24 to 48 hours following the initial assessment , and then at weekly intervals for 4 weeks . The SF-36 ( acute version ) was administered during the initial assessment and at weekly intervals . A type 2,1 intraclass correlation coefficient was used to estimate test-retest reliability . Pearson correlations and one-way analyses of variance were used to examine construct validity . Spearman rank-order correlation coefficients were used to examine the relationship between an independent prognostic rating of change for each patient and change in the LEFS and SF-36 scores . RESULTS Test-retest reliability of the LEFS scores was excellent ( R = .94 [ 95 % lower limit confidence interval ( CI ) = .89 ] ) . Correlations between the LEFS and the SF-36 physical function subscale and physical component score were r=.80 ( 95 % lower limit CI = .73 ) and r = .64 ( 95 % lower limit CI = .54 ) , respectively . There was a higher correlation between the prognostic rating of change and the LEFS than between the prognostic rating of change and the SF-36 physical function score . The potential error associated with a score on the LEFS at a given point in time is + /-5.3 scale points ( 90 % CI ) , the minimal detectable change is 9 scale points ( 90 % CI ) , and the minimal clinical ly important difference is 9 scale points ( 90 % CI ) . CONCLUSION AND DISCUSSION The LEFS is reliable , and construct validity was supported by comparison with the SF-36 . The sensitivity to change of the LEFS was superior to that of the SF-36 in this population . The LEFS is efficient to administer and score and is applicable for research purpose s and clinical decision making for individual patients",
"The role of modular tibial implants in total knee replacement is not fully defined . We performed a prospect i ve r and omised controlled clinical trial using radiostereophotogrammetric analysis to compare the performance of an all-polyethylene tibia with a metal-backed cruciate-retaining condylar design , PFC-Sigma total knee replacement for up to 24 months . There were 51 patients who were r and omised into two treatment groups . There were 10 subsequent withdrawals , leaving 21 all-polyethylene and 20 metal-backed tibial implants . No patient was lost to follow-up . There were no significant demographic differences between the groups . At two years one metal-backed implant showed migration > 1 mm , but no polyethylene implant reached this level . There was a significant increase in the SF-12 and Oxford knee scores after operation in both groups . In an uncomplicated primary total knee replacement the all-polyethylene PFC-Sigma tibial prosthesis showed no statistical difference in migration from that of the metal-backed counterpart . There was no difference in the clinical results as assessed by the SF-12 , the Oxford knee score , alignment or range of movement at 24 months , although these assessment measures were not statistically powered in this study",
" 52 knees scheduled for a total knee arthroplasty were r and omised to either a fixed or a mobile polyethylene bearing . The design was identical in all parts . The knee systems used were the Rotaglide Total Knee System ( RTK ) and the Nuffield Total Knee System ( NTK ) , both from the same manufacturer ( Corin Medical Ltd. , UK ) . All knees implanted were uncemented . The patients were followed for 2 years clinical ly and with radiostereometric analyses to assess migration over time and inducible displacement of the tibial component . Separate analysis of the mobility of the tibial insert in the knees with a mobile bearing was also made . The migration measured with RSA between the 1st and 2nd year expressed as maximum total point motion ( MTPM ) might predict the risk of loosening of the implant . There were no differences between the groups regarding clinical outcome ( HSS Knee score ) , migration or inducible displacement during the 2 years follow-up . The movement between the tibial tray and the mobile meniscal insert expressed as maximum total point motion ( MTPM ) was 6.8+/-3.3 mm at the 1st year follow-up",
"Purpose . To compare the mid-term clinical outcomes in Indian patients after total knee arthroplasty ( TKA ) using a fixed- or mobile-bearing prosthesis . Methods . 120 consecutive patients ( 50 men and 70 women ) aged 55 to 76 ( mean , 63 ) years who had arthritis of the knee with similar deformity and range of motion were r and omised to undergo TKA using a fixed- or mobile-bearing prosthesis . Patients with mediolateral instability and infective arthritis were excluded . Knee Society knee and functional scores , range of motion , and the presence of flexion contracture were assessed . Results . The mean follow-up duration was 3.5 ( range , 1–4.6 ) years . The mid-term outcome of the 2 groups was comparable . One patient with a mobile-bearing prosthesis had recurrent dislocation at postoperative week 2 , owing to iatrogenic medial collateral ligament injury . Conclusion . Long-term studies of both functional and radiological outcomes are needed to determine the indications for fixed- versus mobile-bearing prostheses",
"Renewed interest in mobile-bearing total knee replacement design s has been generated by the concept of self alignment and the suggestion that those design s can accommo date small mismatches in the rotational position of the tibial and femoral components . Self alignment might improve patellar tracking , decrease the prevalence of lateral retinacular release and postoperative patellar tilt or subluxation , improve knee flexion , and improve patellofemoral function during daily activities such as stair climbing . This prospect i ve r and omized study of 240 patients used a single posterior-stabilized femoral component and included three groups of 80 patients : an all-polyethylene group , a modular metal-backed group , and a rotating platform tibia group . The prevalence of lateral retinacular release was 3.8 % in each group . The prevalence of patellar tilt was 5 % ( all-polyethylene group ) , 7 % ( modular metal-backed group ) , and 11 % ( rotating platform group ) . Preoperative motion was not significantly different and both the 3-month flexion ( 112 ° , 110 ° , and 108 ° ) and 1-year flexion ( 116 ° , 117 ° , and 115 ° ) were not significantly different among the all-polyethylene , modular metal-backed , and rotating platform groups , respectively . Preoperative stair climbing scores were not significantly different and both the 3-month ( 38 , 41 , and 35 points ) and 1-year ( 44 , 46 , and 42 points ) scores were not significantly different . In this prospect i ve r and omized study , the rotating platform knee design did not decrease the prevalence of lateral retinacular release or patellar tilt or subluxation and did not increase knee flexion or improve stair climbing ability at 3 months or at 1 year postoperatively when compared with a posterior-stabilized , fixed-bearing knee",
" 33 consecutive patients ( 18 arthrosis , 15 rheumatoid arthritis ) , operated on with total knee arthroplasty and r and omized to cemented ( 18 knees ) or cementless fixation ( 15 knees ) , were investigated with scintimetry 3 , 6 , 12 , and 24 months postoperatively . Migration was evaluated with simultaneous roentgen stereophotogrammetric ( RSA ) examinations . The scintimetric activity in the ipsilateral femoral diaphysis decreased and the activity in the tibial diaphysis increased during the observation period . Constant and low activity was recorded in front of the femoral component . This region was chosen as a reference . Three months after surgery , high activity was noted under the tibial component in knees with a preoperative varus deformity . After 2 years , the activity had decreased to the same level as in the patients with a valgus deformity . Diagnosis and mode of fixation did not influence the activity . Low postoperative activity was recorded in the tibial metaphyses if no rotatory displacement of the tibial component occurred",
"The purpose of this study is to compare the range of motion and clinical outcomes of a st and ard posterior-stabilized ( PS ) vs the high-flex ( HF ) polyethylene tibial insert of a posterior cruciate substituting total knee arthroplasty system . One hundred patients were entered into a prospect i ve , blinded , r and omized clinical trial in which 50 patients received a Genesis II PS insert and 50 patients received a Genesis II HF insert ( Smith & Nephew , Memphis , TN ) . At an average follow-up of 2.7 years ( range , 2.3 - 3.1 years ) , there were no differences in any outcome measures ( Western Ontario and McMaster Universities osteoarthritis index , Short-Form 12 , Knee Society clinical rating scores , anterior knee pain ) . There were no differences ( P = .811 ) in average knee flexion at 2 years ( st and ard , 123 degrees + /- 7 degrees ; HF , 124 degrees + /- 7 degrees ) . In summary , this prospect i ve blinded r and omized clinical trial demonstrated no differences between a PS and HF polyethylene design . Long-term evaluation will be required to comment on differences in polyethylene wear and implant longevity",
"The fixation of tibial components r and omized to insertion with or without cement in twenty-six knees was examined for inducible displacement at six weeks and one year postoperatively with use of roentgen stereophotogrammetric analysis . Furthermore , migration was studied during the first two postoperative years . Inducible displacement was found in all knees at both the six-week and the one-year follow-up examination , but no differences were detected with respect to the type of fixation ( p > 0.05 ) . All tibial components migrated for as long as one year postoperatively , after which most stabilized . No difference was found between the groups with respect to migration during the first two years postoperatively ( p > 0.05 ) , with the exception of subsidence of the component , which was found to be 0.0 ± 0.1 millimeter ( mean and st and ard error of the mean ) for the components inserted with cement and 0.5 ± 0.1 millimeter for the components inserted without cement ( p . Migration after one year was the same for both groups . We found a relationship between inducible displacement at six weeks and at one year as well as one between inducible displacement and migration at one year . To our knowledge , the present study is the first in which the micromotion of an interference-fit prosthesis was found to be similar to that of a device inserted with cement . The results of the present study emphasize the importance of the initial prosthetic fixation",
"BACKGROUND Although excellent long-term results have been reported with cemented tibial fixation , cementless fixation as a means to improve the longevity of total knee prostheses continues to be of interest to clinicians . The purpose of this study was to compare outcomes between cementless tibial fixation with hydroxyapatite and cemented tibial fixation in the first five years following primary total knee arthroplasty . METHODS We performed a prospect i ve , r and omized clinical trial that included eighty-one patients with noninflammatory knee arthritis who underwent primary total knee arthroplasty when they were less than seventy years of age . The subjects were r and omized at the time of surgery to be treated with either cementless tibial fixation with hydroxyapatite or cemented tibial fixation . Evaluations were performed preoperatively and at six months , one year , and five years postoperatively by a physical therapist who was blinded to group allocation . Self-reported pain and function , the primary outcomes , were measured with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and the R AND 36-Item Health Survey ( R AND -36 ) . Complications and revision rates were determined through a review of hospital records and at each patient evaluation . The Knee Society radiographic score was used to evaluate plain radiographs at each assessment . RESULTS Seventy subjects ( 86 % ) completed the five-year assessment . Slightly more pain was reported in the hydroxyapatite group at six months as measured with both the WOMAC and the R AND -36 , a difference that disappeared by one year postoperatively . No differences were seen in function , radiographic findings , or complications . No subject required revision of the tibial prosthesis during the study . CONCLUSIONS At five years postoperatively , there is no difference between cementless tibial fixation with hydroxyapatite and cemented tibial fixation in terms of self-reported pain , function , health-related quality of life , postoperative complications , or radiographic scores",
"One hundred seventy-six patients with osteoarthritis of the knee were r and omized prospect ively into two groups . In both groups the posterior cruciate ligament was released from its femoral attachment . In one group a posterior stabilized tibial component was used whereas in the other group a deep-dish tibial polyethylene component was inserted ( Genesis II ) . The surgical and perioperative technique was identical in both groups and all the implants were cemented to their respective bones . Patients began range of motion exercises within the first few hours after surgery and were allowed weightbearing to tolerance beginning on the first postoperative day . At followup there was no statistical difference in the mean range of flexion ( approximately 116 ° ) , ability to ascend and descend stairs in a bipedal manner ( 80 % ) , pain scores , knee scores ( 94 points ) , stability , or the lack of anterior knee pain . Postoperative implant alignment in the sagittal and coronal planes and on Merchant skyline views was excellent in both groups . There was only one lateral release required and that was in one patient who received a deep-dish component . Using deep-dish implant obviates the need to resect intercondylar femoral bone , decreasing the potential for fracture and maximizing bone volume should revision be necessary in the future",
" Forty-seven knees in 43 patients with severe deformities r and omly received AMK total knee arthroplasty with concave ( C , n = 25 ) or posterior-stabilized ( PS , n = 22 ) polyethylene insert and with resection of the posterior cruciate ligament . Radiostereometric examinations were done postoperatively and after 3 , 12 , and 24 months . Two patients ( 1 C , 1 PS ) underwent revision surgery . At the 2-year follow-up , the median absolute rotations of the tibial inserts ranged from 0.13 degrees to 0.26 degrees ( C vs PS ; P = .1-.7 ) . The maximum total point motion was almost identical in the 2 groups ( C , 0.38 ; PS , 0.39 ; P = .9 ) . Maximum subsidence , lift-off , and Hospital for Special Surgery scores did not differ ( P = .1-.6 ) . Recipients of 20 of 24 knees with concave design and 14 of 19 knees with posterior-stabilized design reported that their knee could be regarded as normal or almost normal . Variations of the configuration of the polyethylene insert did not alter the outcome in the short term",
"AIM Different systems are used for total knee arthroplasty ( TKA ) . Compared were a press-fit femur condyle replacement system with fixed tibial PE-inlay versus a rotating tibia component system with an emphasis on the early functional results . METHOD Patient selection and the use of the Knee Society Score for this r and omized and prospect i ve study were based on the directives for TKA of the german Society for Orthopaedic and Trauma Surgery ( DGOT ) . We examined the patients post-operatively after 1 week , 2 weeks , 6 weeks , 3 months , 6 months , and 1 year . RESULTS After 6 weeks an increase of the total knee score could be seen in both groups . The total knee score of the rotating tibia component increased from 93.96 pre-operatively to 113.57 after 6 weeks , to 139.82 after 3 months , to 154.32 after 6 months , and to 159.65 after one year . The total score with the fixed PE-inlay increased from 79.75 to 111.5 after 6 weeks , to 128.25 after 3 months , to 134.08 after 6 months , and to 130.08 after one year . CONCLUSION After 6 weeks the implant with the rotating tibia component showed a lasting higher score as compared to the implant with a fixed PE-inlay component using the same early rehabilitation and mobilization techniques",
"Twenty-six women and three men ( 34 knees ) with osteoarthrosis were operated with the Miller-Galante I ( Zimmer , Warsaw , IN ) knee prosthesis . The patients were r and omized to either cemented or uncemented fixation of the tibial component . All patients received a TiVaAl alloy tibial plate with four pegs and titanium fiber-mesh undersurface . In the uncemented knees four screws were added . The fixation of the tibial component was determined by roentgen stereophotogrammetric analysis during the first 2 postoperative years . Rotations of the entire tibial component were recorded , as well as proximal or distal translation of various parts of the prosthetic edge corresponding to subsidence and lift-off . The uncemented components displayed almost all rotation and translation during the first 6 weeks , whereas the cemented ones displayed a more gradually increasing migration during the 2 years . Tibial component rotation about the sagittal axis was significantly increased in the uncemented knees throughout the investigation period . This corresponded to increased subsidence medially or laterally in the uncemented knees , whereas lift-off was equal in the two groups . Thin ( 8.5 mm ) uncemented tibial components displayed more subsidence than the thicker ones at the medial or lateral edge 3 months after surgery",
"The effect of changes in the articulating surfaces on the kinematics of the Freeman-Samuelson total knee replacement was evaluated . Twenty-two patients ( 22 knees ) ( median age , 69 years ) were r and omized to a st and ard design with a fixed polyethylene bearing , a design with a mobile bearing , or a new design with a spherical medial femoral condyle with a fixed bearing . The patients were studied with radiostereometry and film-exchangers at 0 ° nonweightbearing and during active weightbearing extension from 45 ° to 15 ° . The center of the tibial tray with a mobile-bearing prosthesis occupied a more anterior position than observed in the design s with a fixed bearing . The medial femoral condyle center had a more posterior position in the st and ard design than in the design with a spherical medial condyle . From a distally displaced position at 45 ° , the medial condylar center displaced a mean of 1.8 mm proximally during extension in the st and ard design and had a constant position in the meniscal design . In the spherical design the medial condyle was displaced proximally at 45 ° and displaced a mean of 1.6 mm distally during extension . The reduced anteroposterior and proximodistal translations in the meniscal design are compatible with improved congruency between the components . The design with a spherical medial condyle stabilized anteroposterior motions , but showed more pronounced proximodistal displacement medially than did the other two design",
"The purpose of the current study was to compare midterm outcomes of posterior cruciate-retaining ( CR ) versus posterior cruciate-substituting ( PS ) procedures using the Genesis II total knee arthroplasty ( TKA ) system ( Smith and Nephew , Memphis , TN ) . Ninety-nine ( 99 ) CR and 93 PS TKA 's were analyzed in this prospect i ve , r and omized clinical trial . Surgeries were performed at seven medical centers by participating surgeons . Clinical outcomes ( Knee Society Score , Range of Motion , WOMAC , SF-12 , and Radiographic Findings ) , in addition to postoperative complications , were evaluated with a minimum follow-up of 5 years . Following data analysis , there were no significant differences in patient demographics or preoperative clinical measures between the two groups . At the latest follow-up interval , no significant differences were found between the CR and PS groups with regards to functional assessment , patient satisfaction , or postoperative complication . However , the PS group did display statistically significant improvements in range of motion when compared with the CR group . The results of this investigation would suggest that , while comparable in regards to supporting good clinical outcomes , the PS Genesis II design does appear to support significantly improved postoperative range of motion when compared with the CR design"
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PURPOSE The evidence has suggested that resveratrol has anti-inflammatory effect ; however , the results are inconsistent and inconclusive . The aim of this study was to assess the effect of resveratrol supplementation on the levels of inflammatory markers through a systematic review and meta- analysis of available r and omized controlled trials ( RCTs ) . METHODS A search strategy was completed using Medline , ISI Web of Science , Directory of Open Access Journal , SID , ProQuest , Cochrane Library , Scopus , and EMBASE up to May 2017 , to identify placebo-controlled RCTs that assessed resveratrol effects on circulating ( serum and plasma ) inflammatory markers ( interleukin [IL]-6 , tumor necrosis factor-α [ TNF-α ] , and high-sensitivity C-reactive protein [ hs-CRP ] ) among adult participants aged 17 years and older in 17 RCTs with a total of 736 subjects . The evaluation of study quality was performed using the Jadad scale . Weighted mean difference ( WMD ) was calculated for evaluating the changes in the inflammatory markers using fixed-effects or r and om-effects models . We performed subgroup and sensitivity analyses to evaluate the heterogeneity of the studies . FINDINGS Seventeen RCTs , including 736 subjects , fulfilled the eligibility criteria and were selected for analyses . The results of meta- analysis found significant reductions in the level of TNF-α ( WMD , -0.44 ; 95 % CI , -0.71 to -0.164 ; P = 0.002 ; Q statistic = 21.60 ; I2 = 49.1 % ; P = 0.02 ) and hs-CRP ( WMD , -0.27 ; 95 % CI , -0.5 to -0.02 ; P = 0.033 ; Q statistic = 26.95 ; I2 = 51.8 % ; P = 0.013 ) after supplementation with resveratrol . Resveratrol supplementation had no significant effect on the level of IL-6 ( WMD , -0.16 ; 95 % CI , -0.53 to 0.20 ; P = 0.38 ; Q statistic = 36.0 ; I2 = 72.3 % ; P = 0.001 ) . Statistically significant heterogeneity was observed for the type of sample in IL-6 and study duration in inflammatory markers IL-6 , TNF-α , and hs-CRP . IMPLICATION S Available evidence from RCTs suggests that resveratrol supplementation significantly reduced TNF-α and hs-CRP levels . Significant improvement in inflammatory markers support resveratrol as an adjunct to pharmacologic management of metabolic diseases | [
"Although resveratrol has widely been studied for its potential health benefits , little is known about its metabolic effects in humans . Our aims were to determine whether the polyphenol resveratrol improves insulin sensitivity in type 2 diabetic patients and to gain some insight into the mechanism of its action . After an initial general examination ( including blood chemistry ) , nineteen patients enrolled in the 4-week-long double-blind study were r and omly assigned into two groups : a resveratrol group receiving oral 2 × 5 mg resveratrol and a control group receiving placebo . Before and after the second and fourth weeks of the trial , insulin resistance/sensitivity , creatinine-normalised ortho-tyrosine level in urine sample s ( as a measure of oxidative stress ) , incretin levels and phosphorylated protein kinase B (pAkt):protein kinase B ( Akt ) ratio in platelets were assessed and statistically analysed . After the fourth week , resveratrol significantly decreased insulin resistance ( homeostasis model of assessment for insulin resistance ) and urinary ortho-tyrosine excretion , while it increased the pAkt : Akt ratio in platelets . On the other h and , it had no effect on parameters that relate to β-cell function ( i.e. homeostasis model of assessment of β-cell function ) . The present study shows for the first time that resveratrol improves insulin sensitivity in humans , which might be due to a resveratrol-induced decrease in oxidative stress that leads to a more efficient insulin signalling via the Akt pathway",
"The protective role of resveratrol in myocardial ischemia/reperfusion is not well understood . The aim of this study was to investigate whether resveratrol modulates inflammation and oxidative stress and the possible role of nuclear factor erythroid 2-related factor 2 (Nrf2)/antioxidant response element ( ARE ) pathway in an ischemia/reperfusion injured rat heart model . Rats were r and omly exposed to sham operation , myocardial ischemia/reperfusion ( MI/R ) alone , and MI/R + resveratrol . The results demonstrated that compared to MI/R , resveratrol improved cardiac function , reduced myocardial infa rct ion area , myocardial myeloperoxidase ( MPO ) levels , serum creatinine kinase ( CK ) and lactate dehydrogenase ( LDH ) levels . Resveratrol also markedly enhanced the activities of antioxidant enzymes superoxide dismutase ( SOD ) and glutathione peroxidase ( GSH-PX ) , and reduced the level of malondialdehyde ( MDA ) in MI/R rats . Resveratrol also enhanced levels of Nrf2 and heme oxygenase-1 . In summary , these results demonstrated that resveratrol exerted significant antioxidant and cardioprotective effects following myocardial ischemia , possibly through the activation of the Nrf2/ARE signaling pathway",
"Nonalcoholic fatty liver disease ( NAFLD ) is the most common chronic liver disease in the world . Resveratrol is a polyphenolic compound with antioxidant capacity that shows beneficial effects on down-regulation of inflammatory mediators and metabolic disorders . We hypothesized that supplementation with resveratrol can further improve the efficacy of lifestyle modifications in the management of NAFLD . In this r and omized , double-blinded , controlled clinical trial , 50 NAFLD patients were supplemented with either a 500-mg resveratrol capsule or a placebo capsule for 12 weeks . Both groups were advised to follow an energy-balanced diet and received physical activity recommendations . Serum liver enzymes , inflammatory markers , hepatic steatosis and fibrosis , dietary intake , anthropometric measurements , and physical activity were assessed at both baseline and the end of the study . In both groups , anthropometric measurements ( weight , body mass index , waist circumference ) , liver enzymes , and steatosis grade improved ( P ) . Resveratrol supplementation was associated with a significant reduction in liver enzyme alanine aminotransferase , inflammatory cytokines , nuclear factor κB activity , serum cytokeratin-18 , and hepatic steatosis grade , as compared with placebo supplementation ( P resveratrol , along with lifestyle modification , is superior to lifestyle modification alone . This is at least partially due to the attenuation of inflammatory markers and hepatocellular apoptosis . More studies are needed to confirm and increase the clinical application of the present results",
"Purpose The grape and wine polyphenol resveratrol exerts cardiovascular benefits but evidence from r and omized human clinical trials is very limited . We investigated dose-depending effects of a resveratrol-containing grape supplement on stable patients with coronary artery disease ( CAD ) treated according to currently accepted guidelines for secondary prevention of cardiovascular disease . Methods In a triple-blind , r and omized , placebo-controlled , one-year follow-up , 3-arm pilot clinical trial , 75 stable-CAD patients received 350 mg/day of placebo , resveratrol-containing grape extract ( grape phenolics plus 8 mg resveratrol ) or conventional grape extract lacking resveratrol during 6 months , and a double dose for the following 6 months . Changes in circulating inflammatory and fibrinolytic biomarkers were analyzed . Moreover , the transcriptional profiling of inflammatory genes in peripheral blood mononuclear cells ( P BMC s ) was explored using microarrays and functional gene expression analysis . Results After 1 year , in contrast to the placebo and conventional grape extract groups , the resveratrol-containing grape extract group showed an increase of the anti-inflammatory serum adiponectin ( 9.6 % , p = 0.01 ) and a decrease of the thrombogenic plasminogen activator inhibitor type 1 ( PAI-1 ) ( −18.6 % , p = 0.05 ) . In addition , 6 key inflammation-related transcription factors were predicted to be significantly activated or inhibited , with 27 extracellular-space acting genes involved in inflammation , cell migration and T-cell interaction signals presenting downregulation ( p No adverse effects were detected in relation to the study products . Conclusions Chronic daily consumption of a resveratrol-containing grape nutraceutical could exert cardiovascular benefits in stable-CAD patients treated according to current evidence -based st and ards , by increasing serum adiponectin , preventing PAI-1 increase and inhibiting atherothrombotic signals in P BMC",
"Background : Exercise can lead to acute oxidative stress , which can result in oxidative damage and induce inflammation . Resveratrol may reduce the levels of inflammatory cytokines . Thus , we investigated the effects of this compound on the plasma levels of tumor necrosis factor-α ( TNF-α ) and interleukin 6 ( IL-6 ) in male professional basketball players . Methods : Twenty healthy male professional basketball players were r and omized into two groups ( 10 each ) . For 6 weeks , they received daily either 200 mg of polygonum cuspidatum extract ( PCE ) st and ardized to contain 20 % trans-resveratrol equivalent to 40 mg trans-resveratrol or placebo . Indices of inflammation were measured before and after 6 weeks of supplementation . Results : There was a significant reduction in plasma levels of TNF-a and IL-6 after 6 weeks of supplementation ; while no change was observed in these markers in the control group . Conclusions : Present study shows that 6 weeks of PCE containing resveratrol supplementation reduces the inflammation in male professional basketball players",
"It has been previously reported that Toll‑like receptor 4 (TLR4)/NF‑κB signaling mediates early inflammation during myocardial ischemia and reperfusion . It has additionally been suggested that resveratrol produces cardioprotective and anti‑inflammatory effects . The aim of the present study was to investigate whether resveratrol could modulate TLR4/NF‑κB signaling , reduce neutrophil accumulation and TNF‑α induction in an ischemia/reperfusion injured rat heart model . Rats were r and omly exposed to a sham operation , myocardial ischemia and reperfusion ( MI/R ) , MI/R + resveratrol or MI/R + resveratrol + L‑NAME . The data showed that following MI/R , the expression of myocardial TLR4 and NF‑κB increased significantly in the area of induced ischemia . As compared with MI/R , resveratrol significantly attenuated the expression of TLR4 and NF‑κB and reduced the levels of myeloperoxidase , serum and myocardial TNF‑α production , myocardial infa rct size and myocardial apoptosis induced by MI/R. All the effects of resveratrol were abolished upon application of L‑NAME , a nitric oxide ( NO ) synthase inhibitor . These data provide evidence that resveratrol inhibits TLR4/NF‑κB signaling in the rat heart subjected to MI/R , and the anti‑inflammatory effect of resveratrol is associated with NO production",
"The polyphenol resveratrol is considered to exert many beneficial actions , such as antioxidant , anti-inflammatory , insulin-sensitizer and anticancer effects . Its benefits in patients with type 2 diabetes mellitus ( T2DM ) are controversial . Our aims were to determine whether resveratrol supplementation at two different dosages ( 500 and 40mg/day ) for 6 months i ) reduced the concentrations of C-reactive-protein ( CRP ) and ii ) ameliorated the metabolic pattern of T2DM patients . In the present double-blind , r and omized , placebo-controlled trial , 192 T2DM patients were r and omized to receive resveratrol 500mg/day ( Resv500arm ) , resveratrol 40mg/day ( Resv40arm ) or placebo for 6-months . At baseline and at the trial end , CRP values , anthropometric , metabolic and liver parameters were determined . No serious adverse event occurred . A dose-dependent , though not significant , CRP decrease of 5.6 % ( Resv40arm ) and 15.9 % ( Resv500arm ) was observed vs placebo . We failed to detect significant differences in weight , BMI , waist circumference , and values of arterial blood pressure , fasting glucose , glycated hemoglobin , insulin , C-peptide , free fatty acids , liver transaminases , uric acid , adiponectin , interleukin-6 , in both the Resv500 and Resv40 arms vs placebo . Total cholesterol and triglycerides slightly increased in the Resv500arm . Subgroup analyses revealed that lower diabetes duration ( in both Resv500 and Resv40arms ) , and , in the Resv500arm , younger age , aspirin use and being a smoker were associated with a significantly higher CRP reduction vs placebo . The supplementations with 40mg/day or 500mg/day resveratrol did neither reduce CRP concentrations , nor improve the metabolic pattern of T2DM patients",
"OBJECTIVE Smokers are characterized by a low- grade systemic inflammatory state and an oxidant-antioxidant imbalance . Few human studies were conducted on the effects of resveratrol , a natural compound with anti-inflammatory and antioxidant properties , and no trial on smokers has been performed to date . We evaluated whether resveratrol has beneficial effects on markers of inflammation and oxidative stress in smokers . METHODS AND RESULTS A r and omized , double- blind , cross-over trial was performed in 50 healthy adult smokers : 25 were r and omly allocated to \" resveratrol-first \" ( 30-days : 500 mg resveratrol/day , 30-days wash-out , 30-days placebo ) and 25 to \" placebo-first \" ( 30-days placebo , 30-days wash-out , 30-days 500 mg resveratrol/day ) . Resveratrol significantly reduced C-reactive protein ( CRP ) and triglyceride concentrations , and increased Total Antioxidant Status ( TAS ) values . After analyzing data with general linear models to assess period and carry-over effects , the ratios of the values after resveratrol to those after placebo were respectively : 0.47 ( 95%CI 0.38 - 0.59 ) -CRP- and 0.71 ( 95%CI 0.65 - 0.78 ) -triglycerides- , while TAS increased by 74.2 μmol/L ( 95%CI 60.8 - 87.6 ) . Uric acid , glucose , insulin , cholesterol , liver enzyme concentrations , and weight , waist circumference , and blood pressure values did not significantly change after resveratrol supplementation . CONCLUSIONS Because resveratrol has anti-inflammatory , anti-oxidant , and hypotriglyceridemic effects , its supplementation may beneficially affect the increased cardiovascular risk of healthy smokers",
"OBJECTIVE This study aim ed to evaluate the effects of short-term ( 60-d ) oral supplementation with calcium fructoborate , resveratrol , and their combination on the clinical and biological statuses of subjects with stable angina pectoris . METHODS A r and omized , double-blinded , active-controlled , parallel clinical trial was conducted in three groups of subjects . Of the total number of subjects included in study ( n = 166 ) , 87 completed the 60-d test treatment study period and 29 followed in parallel their usual medical care and treatment . The primary outcomes were inflammation biomarkers ( high-sensitivity C-reactive protein ) , left ventricular function markers ( N-terminal prohormone of brain natriuretic peptide ) , and lipid markers ( total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and triacylglycerols ) . Quality of life was assessed by the Canadian Cardiovascular Society angina class and the number of angina attacks per week . RESULTS There was a significant decrease of high-sensitivity C-reactive protein in all groups at the 30-d and 60-d visits . This decrease was greater ( 39.7 % at 60 d ) for group 3 ( calcium fructoborate ) , followed by group 2 ( resveratrol plus calcium fructoborate , 30.3 % at 60 d ) . The N-terminal prohormone of brain natriuretic peptide was significantly lowered by resveratrol ( group 1 , 59.7 % at 60 d ) and by calcium fructoborate ( group 3 , 52.6 % at 60 d ) . However , their combination ( group 2 ) was the most effective and induced a decrease of 65.5 % . Lipid markers showed slight changes from baseline in all groups . The improvement in the quality of life was best observed for subjects who received the resveratrol and calcium fructoborate mixture ( group 2 ) . CONCLUSION The results indicate that the combination of resveratrol and calcium fructoborate has beneficial effects in patients with",
"The search for complementary treatments in primary prevention of cardiovascular disease ( CVD ) is a high-priority challenge . Grape and wine polyphenol resveratrol confers CV benefits , in part by exerting anti-inflammatory effects . However , the evidence in human long-term clinical trials has yet to be established . We aim ed to investigate the effects of a dietary resveratrol-rich grape supplement on the inflammatory and fibrinolytic status of subjects at high risk of CVD and treated according to current guidelines for primary prevention of CVD . Seventy-five patients undergoing primary prevention of CVD participated in this triple-blinded , r and omized , parallel , dose-response , placebo-controlled , 1-year follow-up trial . Patients , allocated in 3 groups , consumed placebo ( maltodextrin ) , a resveratrol-rich grape supplement ( resveratrol 8 mg ) , or a conventional grape supplement lacking resveratrol , for the first 6 months and a double dose for the next 6 months . In contrast to placebo and conventional grape supplement , the resveratrol-rich grape supplement significantly decreased high-sensitivity C-reactive protein ( -26 % , p = 0.03 ) , tumor necrosis factor-α ( -19.8 % , p = 0.01 ) , plasminogen activator inhibitor type 1 ( -16.8 % , p = 0.03 ) , and interleukin-6/interleukin-10 ratio ( -24 % , p = 0.04 ) and increased anti-inflammatory interleukin-10 ( 19.8 % , p = 0.00 ) . Adiponectin ( 6.5 % , p = 0.07 ) and soluble intercellular adhesion molecule-1 ( -5.7 % , p = 0.06 ) tended to increase and decrease , respectively . No adverse effects were observed in any patient . In conclusion , 1-year consumption of a resveratrol-rich grape supplement improved the inflammatory and fibrinolytic status in patients who were on statins for primary prevention of CVD and at high CVD risk ( i.e. , with diabetes or hypercholesterolemia plus ≥1 other CV risk factor ) . Our results show for the first time that a dietary intervention with grape resveratrol could complement the gold st and ard therapy in the primary prevention of CVD",
"The role of resveratrol ( Res ) in inflammation induced by ischemia/reperfusion is not well understood . The aim of the present study was to investigate whether Res modulates neutrophil accumulation and tumor necrosis factor-α ( TNF-α ) induction in an ischemia/reperfusion-injured rat heart model . The rats were r and omly exposed to sham surgery , myocardial ischemia/reperfusion ( MI/R ) alone , MI/R + Res , MI/R + Res + L-NG-nitroarginine methyl ester ( L-NAME ) and MI/R + Res + methylene blue ( MB ) . The results demonstrated that compared with MI/R , Res reduced the myocardial infa rct area , myocardial myeloperoxidase levels , serum creatinine kinase and lactate dehydrogenase levels , and serum and myocardial TNF-α production . All the effects of Res demonstrated were inhibited by L-NAME ( a nitric oxide ( NO ) synthase inhibitor ) and MB [ a cyclic guanosine monophosphate ( cGMP ) inhibitor ] . Thus , Res produces cardioprotective and anti-inflammatory effects . These effects may be associated with an increase in NO production , the inhibition of neutrophil accumulation , TNF-α induction and cGMP signaling pathways in myocardium subjected to",
"BACKGROUND AND AIMS Ulcerative colitis ( UC ) is a chronic idiopathic inflammatory disease in which reducing pro-inflammatory and /or increasing anti-inflammatory molecules is the mainstay of treatment . The aim of this study was to evaluate the effects of supplementation with resveratrol as an antiinflammatory and antioxidant agent on inflammation and quality of life in patients with active UC . METHODS AND RESULTS In this r and omized , double-blind , placebo-controlled study , 50 eligible patients with active mild to moderate UC were supplemented with either a 500-mg resveratrol or placebo capsule for 6 weeks . Serum inflammatory markers , activity of NF-κB in peripheral blood mononuclear cells ( P BMC ) and quality of life were assessed at baseline and at the end of the study . Resveratrol supplementation led to a significant reduction in plasma levels of TNF-α ( 19.70 ± 12.80 to 17.20 ± 10.09 pg/mL ) and hs-CRP ( 4764.25 ± 2260.48 to 2584.50 ± 1792.80 ng/mL ) and activity of NF-κB in P BMC s ( 0.19 ± 0.05 to 0.10 ± 0.04 OD ) ( p the score of inflammatory bowel disease question naire -9 ( IBDQ-9 ) increased , whereas the clinical colitis activity index score decreased significantly in the resveratrol group ( 32.72 ± 7.52 to 47.64 ± 8.59 ) ( p improve quality of life and disease clinical colitis activity at least partially through inflammation reduction in patients with UC . Whether these effects will be continued in longer duration of treatment remains to be determined",
"Numerous studies have shown that resveratrol ( RES ) exerts anti-inflammatory effects but human trials evidencing these effects in vivo are limited . Furthermore , the molecular mechanisms triggered in humans following the oral intake of RES are not yet understood . Therefore , the purpose of this study was to investigate the molecular changes in peripheral blood mononuclear cells ( P BMC s ) associated to the one-year daily intake of a RES enriched ( 8 mg ) grape extract ( GE-RES ) in hypertensive male patients with type 2 diabetes mellitus ( T2DM ) . We used microarrays and RT-PCR to analyze expression changes in genes and microRNAs ( miRs ) involved in the inflammatory response modulated by the consumption of GE-RES in comparison to a placebo and GE lacking RES . We also examined the changes in several serobiochemical variables , inflammatory and fibrinolytic markers . Our results showed that supplementation with GE or GE-RES did not affect body weight , blood pressure , glucose , HbA1c or lipids , beyond the values regulated by gold st and ard medication in these patients . We did not find either any significant change on serum inflammatory markers except for a significant reduction of ALP and IL-6 levels . The expression of the pro-inflammatory cytokines CCL3 , IL-1β and TNF-α was significantly reduced and that of the transcriptional repressor LRRFIP-1 increased in P BMC s from patients taking the GE-RES extract . Also , a group of miRs involved in the regulation of the inflammatory response : miR-21 , miR-181b , miR-663 , miR-30c2 , miR-155 and miR-34a were found to be highly correlated and altered in the group consuming the GE-RES for 12 months . Our results provide preliminary evidence that long-term supplementation with a grape extract containing RES downregulates the expression of key pro-inflammatory cytokines with the involvement of inflammation-related miRs in circulating immune cells of T2DM hypertensive medicated patients and support a beneficial immunomodulatory effect in these patients"
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Antihypertensive drugs reduce headache but it is unclear whether there are differences between drug classes . Calcium channel blockers ( CCBs ) decrease variability in systolic blood pressure ( SBPV ) and stroke risk more than other classes , possibly due to decreased vascular tone . If so , there might be a correlation between drug-class effects on variability in SBP and on headache . We determined antihypertensive class effects on SBPV and headache during follow-up in a systematic review of r and omized controlled trials . We determined pooled estimates of treatment effect on group variability in BP ( variance ratio , VR ) and on the odds ratio for headache ( OR ) by r and om-effects meta- analysis . Antihypertensive drugs reduced the incidence of headache compared to placebo ( OR = 0.75 , 95 % CI 0.69–0.82 , p , 198 comparisons , 43,672 patients ) , but there was significant heterogeneity between drug classes ( p = 0.0007 ) with a greater effect of beta-blockers compared to placebo ( VR = 0.49 , 0.33–0.68 , p effectiveness of CCBs ( vs. placebo-OR = 0.95 , 0.79–1.15 , 65 trials ; vs. other drugs-OR = 1.19 , 1.05–1.35 , p = 0.009 , 101 trials ) . Drug-class effects on headache were opposite to effects on variability in SBP ( vs. other drugs : CCB-VR = 0.81 , 0.71–0.85 , p mean SBP . Antihypertensive drugs reduce headache but the effect differs between classes , corresponding to their effects on SBPV and the risk of stroke . This may partly be explained by consistent antihypertensive class effects on vascular tone in the peripheral ( variability ) and cerebrovascular circulations ( headache ) | [
"Background and Purpose — The purpose of this study was to investigate the effect of the angiotensin-converting enzyme inhibitor perindopril on mean arterial blood pressure ( MABP ) , cerebral blood flow ( CBF ) , and glomerular filtration rate in hypertensive stroke patients with moderate to severe internal carotid artery ( ICA ) disease or ICA occlusion . Methods — Twenty-four nonacute ischemic stroke patients who had MABP readings > 100 mm Hg and moderate to severe ICA stenosis or occlusion were r and omized to receive perindopril 4 mg daily or placebo for 14 days . MABP , ICA flow , and both middle cerebral artery ( MCA ) velocity and resistance index were measured before dose , at 5 time points over the subsequent 24 hours , and finally at 2 weeks . Brain hexamethyl propylene amine oxide single photon emission computed tomography scans were performed before drug administration and at time of peak drug effect ( 6 to 8 hours ) after the first dose . Glomerular filtration rate was measured with 51Cr EDTA before medication and at 14 days . Results — A placebo-corrected BP fall of 17/10 mm Hg was seen ( P = 0.017 ) , which was maximal at 5.5 hours . No significant change in ICA flow or MCA velocity was seen between groups . No significant change in hemispheric CBF was seen . The mean change from baseline in the treated group was −0.79 mL · 100 g−1 · min−1 ( 95 % confidence interval [ CI ] , 1.65 to −3.23 ) ; mean change in the placebo group was −1.9 mL · 100 g−1 · min−1 ( 95%CI , 3.02 to −6.92 ) . Peri-infa rct CBF was similarly unaffected . One of the treated patients developed transient acute renal impairment and was withdrawn from the study on day 4 . Conclusions — Perindopril lowers BP without lowering CBF in hypertensive stroke patients with moderate to severe ICA stenosis or occlusion ; monitoring of this patient population for the complications of renal artery stenosis should be considered",
"Abstract Purpose : The aim of the study was to compare effect of perindopril ( 4 mg once a day ) versus acebutolol ( 400 mg once a day ) on cerebral hemodynamics in hypertensive patients . Methods : Thirty untreated patients with mild-to-mode-rate hypertension were studied . Drug influences on Doppler-derived parameters from the cerebral blood flow ( CBF ) velocity wave form were evaluated in a r and omized , double blind , cross-over , placebo controlled study . The mean CBF velocity , pulsatility index ( PI ) , cerebrovascular resistance and index of CBF were calculated from concomitant transcranial Doppler measurements and systemic blood pressure . Results : Acebutolol and perindopril significantly decreased systolic , diastolic and mean blood pressure in relation to placebo . The mean value of CBF velocity increased to a comparable level after both drugs ( 54.9 ± 9.1 cm/s on placebo vs 62.8 ± 14.5 cm/s on perindopril p acebutolol , p the cerebrovascular resistance index decreased similarly after both drugs ( 2.26 ± 0.35 on placebo vs 1.68 ± 0.42 on perindopril p acebutolol p 0.01 ) . The calculated CBF index increased significantly after each drug ( 25.23 ± 7.99 on placebo vs 33.98 ± 11.23 p acebutolol p However , perindopril augmented the CBF index more effectively than acebutolol ( p Among patients with mild-to-moderate hypertension both acebutolol and perindopril beneficially decreased cerebrovascular resistance and increased the CBF index in comparison with placebo . The increase of CBF index was greater after perindopril than acebutolol , which suggests a more significant improvement in cerebral perfusion by perindopril . The non-invasive transcranial Doppler ultrasonography method of CBF velocity measurement may contribute to choosing optimal antihypertensive therapies and to monitor their effect",
"OBJECTIVE To determine if previously hypertensive patients with acute ischemic stroke should be treated with antihypertensive medication in the immediate poststroke period . DESIGN R and omized double-blind , placebo-controlled trial . SETTING Sixteen consecutive hypertensive patients ( four men and 12 women ; mean age , 66 years [ age range , 46 to 83 years ] ) with middle cerebral artery infa rct ion within 72 hours of onset and blood pressure between 170 and 220 mm Hg(systolic ) and 95 and 120 mm Hg ( diastolic ) . INTERVENTION Placebo ( n = 6 ) , nicardipine hydrochloride ( 20 mg [ n = 5 ] ) , captopril ( 12.5 mg [ n = 3 ] ) , or clonidine hydrochloride ( 0.1 mg [ n = 2 ] ) given every 8 hours for 3 days . MAIN OUTCOME MEASURES Decline in blood pressure , change in cerebral blood flow as measured by single photon emission computed tomography , and clinical change as determined by the National Institutes of Health Stroke Scale . RESULTS Blood pressure fell significantly in both the drug-treated group as a whole and in those patients receiving placebo ( P blood pressure levels between these two groups throughout the study period . Patients receiving nicardipine had a consistently lower pressure than the other groups . A significant negative relationship was noted between the maximum blood pressure fall and improvement in cerebral blood flow . There were four patients whose blood pressure dropped by more than 16 % of the baseline value on any 24 hours in the first 3 days . All either failed to increase or actually decreased their cerebral blood flow to the affected area . Three of these patients were treated with nicardipine . There was no significant difference in clinical course between the placebo- and drug-treated groups as a whole . CONCLUSIONS Hypertensive ischemic stroke patients with a moderate elevation of blood pressure in the first few days may not require antihypertensive therapy . Nicardipine and possibly other calcium channel blockers may cause an excessive fall in blood pressure and impair cerebral blood flow in these patients and should therefore be used with caution",
"Background and Purpose — Angiotensin-converting enzyme ( ACE ) inhibitor – based therapy reduces the recurrence of stroke . The present study assessed the effects of long-term ACE inhibitor therapy on cerebral circulation in patients with previous minor stroke . Methods — After a run-in period , 19 patients were r and omized to ACE inhibitor therapy ( n=9 ; 4 mg of perindopril daily ; mean age , 64±8 years ; mean systolic/diastolic blood pressure [BP]±SD , 133±12/77±9 mm Hg ) or placebo therapy ( n=10 ; mean age , 66±9 years ; mean BP , 139±10/78±8 mm Hg ) . Cerebral blood flow ( CBF ) was measured during hypercapnia , normocapnia , and hypocapnia using a positron emission tomography with H215O at entry into the study and after 3 to 12 months . Cerebral perfusion reserve ( CPR ) was defined as percent CBF response to a 1 mm Hg change in arterial partial pressure of CO2 between hypercapnia and hypocapnia . Results — Systolic/diastolic BP and CBF during normocapnia showed no significant changes between entry and completion of the trial in the perindopril and placebo groups . Mean value of CPR showed a significant increase in the perindopril group ( from 3.7±1.7%/mm Hg to 4.8±1.7%/mm Hg ; P the placebo group ( from 4.1±0.8%/mm Hg to 4.2±0.6%/mm Hg ; NS ) . Statistical parametric mapping analysis also showed global and significant increase ( P in CPR in the perindopril group alone . Conclusions — Long-term ACE inhibitor – based therapy had a beneficial effect on the cerebral circulation by improving CPR in patients with previous minor stroke",
"Objectives : Prevalence studies of the association between blood pressure and headache have shown conflicting results . The aim was to analyse the relation between blood pressure and risk of headache in a prospect i ve study . Methods : A total of 22 685 adults not likely to have headache , had their baseline blood pressure measured in 1984–6 , and responded to a headache question naire at follow up 11 years later ( 1995–7 ) . The relative risk of headache ( migraine or non-migrainous headache ) was estimated in relation to blood pressure at baseline . Results : Those with a systolic blood pressure of 150 mm Hg or higher had 30 % lower risk ( risk ratio (RR)=0.7 , 95 % CI 0.6–0.8 ) of having non-migrainous headache at follow up compared with those with systolic pressure lower than 140 mm Hg . For diastolic blood pressure , the risk of non-migrainous headache decreased with increasing values , and these findings were similar for both sexes , and were not influenced by use of antihypertensive medication . For migraine , there was no clear association with blood pressure . Conclusion : In the first prospect i ve study of blood pressure and the risk of headache , high systolic and diastolic pressures were associated with reduced risk of non-migrainous headache . One possible explanation may be the phenomenon of hypertension associated hypalgesia , which probably involves the baroreflex system influencing nociception in the brain stem or spinal cord",
"The effects of angiotensin II receptor blockers on cerebral hemodynamics in humans have not been well eluci date d. The present study evaluated the effects of losartan on cerebral hemodynamics in hypertensive patients using positron emission tomography . Ten patients with essential hypertension ( mean age , 60.8 years ) were examined . In each patient , regional cerebral blood flow was measured by [ O-15 ] labeled water positron emission tomography before and after the oral administration of losartan for 8 to 23 weeks . In 8 patients , the baseline regional cerebral blood flow measurement was followed by 1,000 mg of acetazolamide challenge to measure the cerebral perfusion reserve . Systemic blood pressures before and after treatment were 153.8±10.8/96.0±6.5 mmHg ( systolic mean±SD/diastolic mean±SD ) and 133.4±11.2/83.6±6.5 mmHg , respectively ; this difference was significant . The baseline global cerebral blood flow values before and after treatment were 38.4±6.9 ml/min/100 g and 38.2±8.2 ml/min/100 g , respectively ; this difference was not significant . The results of the global cerebral blood flow response to the acetazolamide challenges were not statistically different before and after treatment . A regional analysis showed no statistical difference in regional cerebral blood flow or cerebral perfusion reserve throughout the brain before and after treatment . Losartan 's effect on reducing the blood pressure did not affect either the baseline regional cerebral blood flow or the cerebral perfusion reserve in patients with mild to moderate hypertension . The inclusion of losartan in anti-hypertensive regimens could be advantageous for cerebral circulation in patients with essential hypertension",
"We undertook a double-blind , placebo-controlled study to determine the effectiveness of verapamil hydrochloride for the prophylaxis of migraine . Twelve patients were given either verapamil hydrochloride , 80 mg four times daily , or placebo in r and om order during two consecutive three-month periods . Migraine frequency , severity , and duration were quantified by daily logs and monthly question naires . Ten of the 12 patients had fewer migraines during verapamil therapy . Migraine frequency decreased from 6.7 to 3.8 migraines per patient per month , for a mean decrease of 49 % . Headache unit index fell from an average of 0.61 to 0.44 . We conclude that verapamil is effective in the prophylaxis of migraine and that verapamil might be considered one alternative in the development of a regimen for the prophylaxis of migraine",
"The aim of this study was to evaluate changes in cerebral hemodynamics in young patients with uncomplicated hypertension before and after effective antihypertensive treatment with a beta-blocker drug . Changes in mean flow velocity in the middle cerebral artery from normal condition to hypercapnia were evaluated by means of a transcranial Doppler in 42 hypertensive patients and 21 healthy subjects comparable for age and sex distribution . We obtained hypercapnia with breath-holding and evaluated cerebrovascular reactivity with the breath-holding index ( BHI ) . After a baseline evaluation ( time 0 ) , patients were r and omly assigned to a placebo ( group 1 ) or atenolol ( group 2 ) therapy . The evaluation was repeated after 30 ( time 1 ) and 60 ( time 2 ) days of treatment . Before treatment , hypertensive patients had significantly lower BHI values ( 0.96 + /- 0.1 group 1 and 0.85 + /- 0.3 group 2 ) than controls ( 1.69 + /- 0.4 ) ( P mean blood pressure significantly decreased in group 2 patients . In the same group , BHI values significantly increased with respect to the pre-treatment evaluation : 1.39 + /- 0.2 at time 1 and 1.44 + /- 0.2 at time 2 ( P mean blood pressure and BHI values remained unchanged in the placebo group . Furthermore , BHI values were significantly higher in group 2 than in group 1 patients at times 1 ( P capability of cerebral vessels to adapt to functional changes . This condition , which is reversible after treatment , could be implicated in the increased susceptibility to ischemic stroke in hypertension",
"This r and omized , double-blind , placebo-controlled study was aim ed at detecting cerebrovascular effects of isradipine and enalapril in patients with moderate hypertension depending on the presence and grade on unilateral stenosis of internal carotid artery ( ICA ) . We evaluated carotid vascular resistance by using Doppler analysis and regional cerebral blood flow ( rCBF ) by using 133Xe-clearance technique before and after a single 5-mg oral dose of isradipine , enalapril , or placebo . Their effects were r and omly and consecutively tested in 73 patients with essential hypertension subdivided into three groups : without carotid occlusive lesions , with moderate ( 50 - 75 % ) , and with severe ( 76 - 99 % ) unilateral asymptomatic ICA stenosis . There were no differences in age , gender , and antihypertensive effects of the drugs between these three subgroups . Three major variants of cerebrovascular drug effects were observed : absence of changes ( variant I ) , decrease in carotid vascular resistance with increase in rCBF and elimination of side-to-side asymmetry ( variant II ) , and increase in carotid vascular resistance with further reduction of rCBF ipsilaterally ICA stenosis , and increased side-to-side asymmetry ( variant III ) . Frequency of variant III was significantly higher in patients with severe ICA stenosis . Enalapril produced variant I of cerebrovascular effects in most patients examined ; variant III was observed only in 13 % of patients with severe ICA stenosis . Isradipine produced variant I of cerebrovascular effects much less frequently than did enalapril . For this drug , variant II was most typical in patients without ICA stenosis and with moderate ICA stenosis . In 43.5 % of patients with severe ICA stenosis , however , isradipine produced reduction of cerebral perfusion . Presumably the presence of ICA stenosis , especially > 75 % , increases the risk of cerebrovascular disorders in antihypertensive therapy . In patients with severe ICA stenosis , treatment with enalapril appears to be safer than that with isradipine",
"CONTEXT There is a paucity of effective , well-tolerated drugs available for migraine prophylaxis . OBJECTIVE To determine whether treatment with the angiotensin II receptor blocker c and esartan is effective as a migraine-prophylactic drug . DESIGN AND SETTING R and omized , double-blind , placebo-controlled crossover study performed in a Norwegian neurological outpatient clinic from January 2001 to February 2002 . PATIENTS Sixty patients aged 18 to 65 years with 2 to 6 migraine attacks per month were recruited mainly from newspaper advertisements . INTERVENTIONS A placebo run-in period of 4 weeks was followed by two 12-week treatment periods separated by 4 weeks of placebo washout . Thirty patients were r and omly assigned to receive one 16-mg c and esartan cilexetil tablet daily in the first treatment period followed by 1 placebo tablet daily in the second period . The remaining 30 received placebo followed by c and esartan . MAIN OUTCOME MEASURES The primary end point was number of days with headache ; secondary end points included hours with headache , days with migraine , hours with migraine , headache severity index , level of disability , doses of triptans , doses of analgesics , acceptability of treatment , days of sick leave , and quality -of-life variables on the Short Form 36 question naire . RESULTS In a period of 12 weeks , the mean number of days with headache was 18.5 with placebo vs 13.6 with c and esartan ( P = .001 ) in the intention-to-treat analysis ( n = 57 ) . Some secondary end points also favored c and esartan , including hours with headache ( 139 vs 95 ; P days with migraine ( 12.6 vs 9.0 ; P hours with migraine ( 92.2 vs 59.4 ; P headache severity index ( 293 vs 191 ; P level of disability ( 20.6 vs 14.1 ; P days of sick leave ( 3.9 vs 1.4 ; P = .01 ) , although there were no significant differences in health-related quality of life . The number of c and esartan responders ( reduction of > or = 50 % compared with placebo ) was 18 ( 31.6 % ) of 57 for days with headache and 23 ( 40.4 % ) of 57 for days with migraine . Adverse events were similar in the 2 periods . CONCLUSION In this study , the angiotensin II receptor blocker c and esartan provided effective migraine prophylaxis , with a tolerability profile comparable with that of placebo",
"Background Secondary prevention of stroke with antihypertensive drugs is now st and ard practice , but it is unclear how soon after a cerebrovascular event antihypertensive therapy should be initiated or re-started . Due to impaired cerebral autoregulation , changes in systemic blood pressure may be reflected in cerebral perfusion , especially in hypertensive patients immediately post-stroke . Conversely , early initiation in hospital may better assure continued long-term treatment . We have investigated the effect of the angiotensin II receptor antagonist ( ARA ) losartan on mean arterial blood pressure ( MABP ) , global and focal cerebral blood flow ( CBF ) , and glomerular filtration rate ( GFR ) in hypertensive patients 2–7 days after stroke . Methods Twenty-four patients without occlusive carotid disease but with MABP between 110 and 145 mmHg were studied within 2–7 days of ischaemic stroke/transient ischaemic attack ( TIA ) . They were r and omized to receive either placebo or losartan ( 25 or 50 mg daily ) . MABP and internal carotid artery ( ICA ) flow were measured at baseline , over the following 24 h and at 2 weeks . Brain hexamethylpropyleneamine oxime single photon emission computed tomography ( HMPAO SPECT ) was performed before dosing and at the estimated time of peak drug effect ( 6–8 h after the first dose ) . GFR was measured at baseline and at 2 weeks . Results The mean National Institutes of Health ( NIH ) score of r and omized patients was 2.6 ; losartan was generally well tolerated and no patient suffered a deterioration in neurological function . A mean placebo-corrected intra-subject reduction in MABP of 9.5 mmHg was observed in treated patients from 1–12 h ( P = 0.0001 ) , with a maximal fall of 18.1 mmHg at 9 h post-dose ( P = 0.002 ) . No change occurred in ICA flow , or cortical or hemispheric CBF measured by HMPAO SPECT . No significant change in GFR was seen within or between groups . Discussion Losartan may be introduced within 2–7 days of mild stroke in hypertensive patients in whom significant carotid occlusive disease has been excluded without affecting global or regional CBF , or affecting GFR",
"Amlodipine and nitrendipine are calcium antagonists of the 1,4-dihydropyridine group which differ in their pharmacokinetic and pharmacodynamic properties . The clinical relevance of these differences was investigated in a study design ed to compare the efficacy and safety of once-daily amlodipine ( 5 mg ) and nitrendipine ( 20 mg ) in patients with mild-to-moderate essential hypertension . Ambulatory blood pressure monitoring and conventional measurements showed that amlodipine and nitrendipine produced comparable reductions in blood pressure after 4 weeks of treatment . However , the onset of the antihypertensive effect was gradual for amlodipine , while most of the reduction achieved at the end of treatment with nitrendipine was seen after the first dose . There were no significant changes in heart rate with amlodipine , but significant increases occurred during the first 6 h of nitrendipine treatment . Amlodipine was associated with a significantly lower incidence of vasodilator-related adverse effects at initiation of therapy ( headache , flushing , tachycardia ) compared with nitrendipine , which may reflect its slower onset of action . The different pharmacodynamic and toleration profiles of amlodipine and nitrendipine at therapeutically equivalent doses suggest that amlodipine may have advantages in the treatment of hypertension , especially in terms of the low incidence of acute side effects , which may ultimately translate into improved patient compliance"
] | 41163242-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Hormone therapy ( HT ) is widely used for controlling menopausal symptoms and has also been used for the management and prevention of cardiovascular disease , osteoporosis and dementia in older women . This is an up date d version of the original Cochrane review first published in 2005 . OBJECTIVES To assess the effect of long-term HT on mortality , cardiovascular outcomes , cancer , gallbladder disease , cognition , fractures and quality of life . SEARCH STRATEGY We search ed the following data bases to November 2007 : Trials Register of the Cochrane Menstrual Disorders and Subfertility Group , Cochrane Central Register of Controlled Trials , MEDLINE , EMBASE , Biological Abstract s. Also relevant non-indexed journals and conference abstract s. SELECTION CRITERIA R and omised double-blind trials of HT versus placebo , taken for at least one year by perimenopausal or postmenopausal women . HT included oestrogens , with or without progestogens , via oral , transdermal , subcutaneous or transnasal routes . DATA COLLECTION AND ANALYSIS Two authors independently assessed trial quality and extracted data . MAIN RESULTS Nineteen trials involving 41,904 women were included . In relatively healthy women , combined continuous HT significantly increased the risk of venous thrombo-embolism or coronary event ( after one year 's use ) , stroke ( after three years ) , breast cancer and gallbladder disease . Long-term oestrogen-only HT significantly increased the risk of venous thrombo-embolism , stroke and gallbladder disease ( after one to two years , three years and seven years ' use respectively ) , but did not significantly increase the risk of breast cancer . The only statistically significant benefits of HT were a decreased incidence of fractures and ( for combined HT ) colon cancer , with long-term use . Among women aged over 65 who were relatively healthy ( i.e. generally fit , without overt disease ) and taking continuous combined HT , there was a statistically significant increase in the incidence of dementia . Among women with cardiovascular disease , long-term use of combined continuous HT significantly increased the risk of venous thrombo-embolism . One trial analysed subgroups of 2839 relatively healthy 50 to 59 year old women taking combined continuous HT and 1637 taking oestrogen-only HT , versus similar-sized placebo groups . The only significantly increased risk reported was for venous thrombo-embolism in women taking combined continuous HT : their absolute risk remained low , at less than 1/500 . However , this study was not powered to detect differences between groups of younger women . AUTHORS ' CONCLUSIONS HT is not indicated for the routine management of chronic disease . We need more evidence on the safety of HT for menopausal symptom control , though short-term use appears to be relatively safe for healthy younger women | [
"Background — The Women ’s Health Initiative ( WHI ) Estrogen Alone trial assessed the balance of benefits and risks of hormone use in healthy postmenopausal women . The trial was stopped prematurely because there was no benefit for coronary heart disease and an increased risk of stroke . This report provides a thorough analysis of the stroke finding using the final results from the completed trial data base . Methods and Results — The WHI Estrogen Alone hormone trial is a multicenter , double-blind , placebo-controlled , r and omized clinical trial in 10 739 women aged 50 to 79 years who were given daily conjugated equine estrogen ( CEE ; 0.625 mg ; n=5310 ) or placebo ( n=5429 ) . During an average follow-up of 7.1 years , there were 168 strokes in the CEE group and 127 in the placebo group ; 80.3 % of strokes were ischemic . For all stroke the intention-to-treat hazard ratio [ HR ] ( 95 % CI ) for CEE versus placebo was 1.37 ( 1.09 to 1.73 ) . The HR ( 95 % CI ) was 1.55 ( 1.19 to 2.01 ) for ischemic stroke and 0.64 ( 0.35 , 1.18 ) for hemorrhagic stroke . The HRs indicate excess risk of ischemic stroke was apparent in all categories of baseline stroke risk , including younger and more recently menopausal women and in women with prior or current use of statins or aspirin . Conclusions — CEE increases the risk of ischemic stroke in generally healthy postmenopausal women . The excess risk appeared to be present in all subgroups of women examined , including younger and more recently menopausal women . There was no convincing evidence to suggest that CEE had an effect on the risk of hemorrhagic stroke",
"CONTEXT The Women 's Health Initiative trial of combined estrogen plus progestin was stopped early when overall health risks , including invasive breast cancer , exceeded benefits . Outst and ing issues not previously addressed include characteristics of breast cancers observed among women using hormones and whether diagnosis may be influenced by hormone effects on mammography . OBJECTIVE To determine the relationship among estrogen plus progestin use , breast cancer characteristics , and mammography recommendations . DESIGN , SETTING , AND PARTICIPANTS Following a comprehensive breast cancer risk assessment , 16 608 postmenopausal women aged 50 to 79 years with an intact uterus were r and omly assigned to receive combined conjugated equine estrogens ( 0.625 mg/d ) plus medroxyprogesterone acetate ( 2.5 mg/d ) or placebo from 1993 to 1998 at 40 clinical centers . Screening mammography and clinical breast examinations were performed at baseline and yearly thereafter . MAIN OUTCOME MEASURES Breast cancer number and characteristics , and frequency of abnormal mammograms by estrogen plus progestin exposure . RESULTS In intent-to-treat analyses , estrogen plus progestin increased total ( 245 vs 185 cases ; hazard ratio [ HR ] , 1.24 ; weighted P invasive ( 199 vs 150 cases ; HR , 1.24 ; weighted P = .003 ) breast cancers compared with placebo . The invasive breast cancers diagnosed in the estrogen plus progestin group were similar in histology and grade but were larger ( mean [ SD ] , 1.7 cm [ 1.1 ] vs 1.5 cm [ 0.9 ] , respectively ; P = .04 ) and were at more advanced stage ( regional/metastatic 25.4 % vs 16.0 % , respectively ; P = .04 ) compared with those diagnosed in the placebo group . After 1 year , the percentage of women with abnormal mammograms was substantially greater in the estrogen plus progestin group ( 716 [ 9.4 % ] of 7656 ) compared with placebo group ( 398 [ 5.4 % ] of 7310 ; P estrogen plus progestin use increases incident breast cancers , which are diagnosed at a more advanced stage compared with placebo use , and also substantially increases the percentage of women with abnormal mammograms . These results suggest estrogen plus progestin may stimulate breast cancer growth and hinder breast cancer diagnosis",
"Background Although breast cancer risk is greater in users of estrogen – progestin than estrogen-only formulations of menopausal hormonal therapy , reports on their effects have been somewhat inconsistent . We investigated whether the timing of these therapies affected breast cancer incidence . Methods A total of 1 129 025 postmenopausal UK women provided prospect i ve information on hormonal therapy use and other factors relevant for breast cancer risk . We used Cox regression to estimate adjusted relative risks ( RRs ) of breast cancer in hormonal therapy users vs never users and calculated st and ardized incidence rates . All statistical tests were two-sided . Results During 4.05 million woman-years of follow-up , 15 759 incident breast cancers occurred , with 7107 in current users of hormonal therapy . Breast cancer incidence was increased in current users of hormonal therapy , returning to that of never users a few years after use had ceased . The relative risks for breast cancer in current users were greater if hormonal therapy was begun before or soon after menopause than after a longer gap ( Pheterogeneity estrogen-only and estrogen-progestin formulations ) . Among current users of estrogen-only formulations , there was little or no increase in risk if use began 5 years or more after menopause ( RR = 1.05 , 95 % confidence interval [ CI ] = 0.89 to 1.24 ) , but risk was statistically significantly increased if use began before or less than 5 years after menopause ( RR = 1.43 , 95 % CI = 1.35 to 1.51 ) . A similar pattern was observed among current users of estrogen – progestin formulations ( RR = 1.53 , 95 % CI = 1.38 to 1.70 , and RR = 2.04 , 95 % CI = 1.95 to 2.14 , respectively ) . At 50–59 years of age , annual st and ardized incidence rates for breast cancer were 0.30 % ( 95 % CI = 0.29 % to 0.31 % ) among never users of hormone therapy and 0.43 % ( 95 % CI = 0.42 % to 0.45 % ) and 0.61 % ( 95 % CI = 0.59 % to 0.64 % ) , respectively , among current users of estrogen-only and estrogen – progestin formulations who began use less than 5 years after menopause . Conclusions There was substantial heterogeneity in breast cancer risk among current users of hormonal therapy . Risks were greater among users of estrogen – progestin than estrogen-only formulations and if hormonal therapy started at around the time of menopause than later",
"CONTEXT The Women 's Health Initiative Estrogen-Aone trial comparing conjugated equine estrogens ( CEE ) with placebo was stopped early because of an increased stroke incidence and no reduction in risk of coronary heart disease . Preliminary results suggesting possible reduction in breast cancers warranted more detailed analysis . OBJECTIVE To determine the effects of CEE on breast cancers and mammographic findings . DESIGN , SETTING , AND PARTICIPANTS Following breast cancer risk assessment , 10,739 postmenopausal women aged 50 to 79 years with prior hysterectomy were r and omized to CEE or placebo at 40 US clinical centers from 1993 through 1998 . Mammography screenings and clinical breast examinations were performed at baseline and annually . All breast cancers diagnosed through February 29 , 2004 , are included . INTERVENTION A dose of 0.625 mg/d of CEE or an identical-appearing placebo . MAIN OUTCOME MEASURES Breast cancer incidence , tumor characteristics , and mammogram findings . RESULTS After a mean ( SD ) follow-up of 7.1 ( 1.6 ) years , the invasive breast cancer hazard ratio ( HR ) for women assigned to CEE vs placebo was 0.80 ( 95 % confidence interval [ CI ] , 0.62 - 1.04 ; P = .09 ) with annualized rates of 0.28 % ( 104 cases in the CEE group ) and 0.34 % ( 133 cases in the placebo group ) . In exploratory analyses , ductal carcinomas ( HR , 0.71 ; 95 % CI , 0.52 - 0.99 ) were reduced in the CEE group vs placebo group ; however , the test for interaction by tumor type was not significant ( P = .054 ) . At 1 year , 9.2 % of women in the CEE group had mammograms with abnormalities requiring follow-up vs 5.5 % in the placebo group ( P postmenopausal women with prior hysterectomy . However , treatment with CEE increases the frequency of mammography screening requiring short interval follow-up . Initiation of CEE should be based on consideration of the individual woman 's potential risks and benefits . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00000611",
"The authors further analyzed results from the Women 's Health Initiative r and omized trials ( 1993 - 2004 ) of conjugated equine estrogens , with or without medroxyprogesterone acetate , focusing on health benefits versus risks among women who initiated hormone therapy soon after menopause . Data from the Women 's Health Initiative observational study ( 1993 - 2004 ) were included in some analyses for additional precision . Results are presented here for incident coronary heart disease , stroke , venous thromboembolism , breast cancer , colorectal cancer , endometrial cancer , or hip fracture ; death from other causes ; a summary global index ; total cancer ; and total mortality . Hazard ratios for breast cancer and total cancer were comparatively higher ( P women who initiated hormone therapy soon after menopause , for both regimens . Among these women , use of conjugated equine estrogens appeared to produce elevations in venous thromboembolism and stroke and a reduction in hip fracture . Estrogen plus progestin results among women who initiated use soon after menopause were similar for venous thromboembolism , stroke , and hip fracture but also included evidence of longer-term elevations in breast cancer , total cancer , and the global index . These analyses provide little support for the hypothesis of favorable effects among women who initiate postmenopausal estrogen use soon after menopause , either for coronary heart disease or for health benefits versus risk indices considered",
"BACKGROUND Observational studies examining the role of estrogen in the risk of kidney stone formation have shown conflicting results . However , r and omized trial evidence on nephrolithiasis risk with estrogen therapy in postmenopausal women is lacking . METHODS We review ed the incidence of nephrolithiasis in the Women 's Health Initiative estrogen-alone and estrogen plus progestin trials conducted at 40 US clinical centers . A total of 10 739 postmenopausal women with hysterectomy were r and omized to receive 0.625 mg/d of conjugated equine estrogens ( CEE ) or placebo , and 16 608 postmenopausal women without hysterectomy were r and omized to receive placebo or estrogen plus progestin given as CEE plus medroxyprogesterone acetate ( 2.5 mg/d ) . The incidence of nephrolithiasis was determined for an average follow-up of 7.1 years for the CEE trial and 5.6 years for the estrogen plus progestin trial . RESULTS Baseline demographic characteristics and risk factors for nephrolithiasis were similar in the placebo and treatment arms . Estrogen therapy was associated with a significant increase in nephrolithiasis risk from 34 to 39 cases per 10 000 person-years ( hazard ratio , 1.21 ; 95 % confidence interval , 1.03 - 1.44 ) . Censoring data from women when they ceased to adhere to study medication increased the hazard ratio to 1.39 ( 95 % confidence interval , 1.08 - 1.78 ) . The increased nephrolithiasis risk was independent of progestin coadministration , and effects did not vary significantly according to prer and omization history of nephrolithiasis . CONCLUSIONS These data suggest that estrogen therapy increases the risk of nephrolithiasis in healthy postmenopausal women . These findings should be considered in decision making regarding postmenopausal estrogen use . The mechanisms underlying this higher susceptibility remain to be determined . Trial Registration clinical trials.gov Identifier : NCT0000611",
"OBJECTIVES To determine whether small decrements in global cognitive function that conjugated equine estrogen ( CEE ) therapies have been shown to produce in older women persist after cessation and extend to specific cognitive domains . DESIGN R and omized controlled clinical trial . SETTING Fourteen clinical centers of the Women 's Health Initiative . PARTICIPANTS Two thous and three hundred four women aged 65 to 80 free of probable dementia at enrollment . INTERVENTION CEE 0.625 mg/d with or without medroxyprogesterone acetate ( MPA , 10 mg/d ) and matching placebos . MEASUREMENTS Annual administrations of a battery of cognitive tests during and after the trial . RESULTS Assignment to CEE-based therapies was associated with small mean relative decrements in global cognitive function and several domain-specific cognitive functions during the trial , which largely persisted through up to 4 years after the trial . The strongest statistical evidence was for global cognitive function ( 0.07-st and ard deviation decrements during ( P=.007 ) and after ( P=.01 ) the trial . For domain-specific scores , the mean decrements were slightly smaller , were less significant , and tended to be larger for CEE-alone therapy . CONCLUSION CEE-based therapies , when initiated after the age of 65 , produce a small broad-based decrement in cognitive function that persists after their use is stopped , but the differences in cognitive function are small and would not be detectable or have clinical significance for an individual woman . Differences in effects between cognitive domains suggest that more than one mechanism may be involved",
"UNLABELLED Further analyses from the Women 's Health Initiative estrogen trial shows that CEE reduced fracture risk . The fracture reduction at the hip did not differ appreciably among risk strata . These data do not support overall benefit over risk , even in women at highest risk for fracture . INTRODUCTION The Women 's Health Initiative provided evidence that conjugated equine estrogen ( CEE ) can significantly reduce fracture risk in postmenopausal women . Additional analysis of the effects of CEE on BMD and fracture are presented . MATERIAL S AND METHODS Postmenopausal women 50 - 79 years of age with hysterectomy were r and omized to CEE 0.625 mg daily ( n = 5310 ) or placebo ( n = 5429 ) and followed for an average 7.1 years . Fracture incidence was assessed by semiannual question naire and verified by adjudication of radiology reports . BMD was measured in a subset of women ( N = 938 ) at baseline and years 1 , 3 , and 6 . A global index was used to examine whether the balance of risks and benefits differed by baseline fracture risk . RESULTS CEE reduced the risk of hip ( hazard ratio [ HR ] , 0.65 ; 95 % CI , 0.45 - 0.94 ) , clinical vertebral ( HR , 0.64 ; 95 % CI , 0.44 - 0.93 ) , wrist/lower arm ( HR , 0.58 ; 95 % CI , 0.47 - 0.72 ) , and total fracture ( HR , 0.71 ; 95 % CI , 0.64 - 0.80 ) . This effect did not differ among strata according to age , oophorectomy status , past hormone use , race/ethnicity , fall frequency , physical activity , or fracture history . Total fracture reduction was less in women at the lowest predicted fracture risk in both absolute and relative terms ( HR , 0.86 ; 95 % CI , 0.68 - 1.08 ) . CEE also provided modest but consistent positive effects on BMD . The HRs of the global index for CEE were relatively balanced across tertiles of summary fracture risk ( lowest risk : HR , 0.81 ; 95 % CI , 0.62 - 1.05 ; mid risk : HR , 1.09 ; 95 % CI , 0.92 - 1.30 ; highest risk : HR , 1.04 ; 95 % CI , 0.88 - 1.23 ; interaction , p = 0.42 ) . CONCLUSIONS CEE reduces the risk of fracture and increases BMD in hysterectomized postmenopausal women . Even among the women with the highest risk for fractures , when considering the effects of estrogen on other important health outcomes , a summary of the burden of monitored effects does not indicate a significant net benefit",
"CONTEXT The Heart and Estrogen/progestin Replacement Study ( HERS ) found no overall reduction in risk of coronary heart disease ( CHD ) events among postmenopausal women with CHD . However , in the hormone group , findings did suggest a higher risk of CHD events during the first year , and a decreased risk during years 3 to 5 . OBJECTIVE To determine if the risk reduction observed in the later years of HERS persisted and result ed in an overall reduced risk of CHD events with additional years of follow-up . DESIGN AND SETTING R and omized , blinded , placebo-controlled trial of 4.1 years ' duration ( HERS ) and subsequent unblinded follow-up for 2.7 years ( HERS II ) conducted at outpatient and community setting s at 20 US clinical centers . PARTICIPANTS A total of 2763 postmenopausal women with CHD and average age of 67 years at enrollment in HERS ; 2321 women ( 93 % of those surviving ) consented to follow-up in HERS II . INTERVENTION Participants were r and omly assigned to receive 0.625 mg/d of conjugated estrogens and 2.5 mg of medroxyprogesterone acetate ( n = 1380 ) , or placebo ( n = 1383 ) during HERS ; open-label hormone therapy was prescribed at personal physicians ' discretion during HERS II . The proportions with at least 80 % adherence to hormones declined from 81 % ( year 1 ) to 45 % ( year 6 ) in the hormone group , and increased from 0 % ( year 1 ) to 8 % ( year 6 ) in the placebo group . MAIN OUTCOME MEASURES The primary outcome was nonfatal myocardial infa rct ion and CHD death . Secondary cardiovascular events were coronary revascularization , hospitalization for unstable angina or congestive heart failure , nonfatal ventricular arrhythmia , sudden death , stroke or transient ischemic attack , and peripheral arterial disease . RESULTS There were no significant decreases in rates of primary CHD events or secondary cardiovascular events among women assigned to the hormone group compared with the placebo group in HERS , HERS II , or overall . The unadjusted relative hazard ( RH ) for CHD events in HERS was 0.99 ( 95 % confidence interval [ CI ] , 0.81 - 1.22 ) ; HERS II , 1.00 ( 95 % CI , 0.77 - 1.29 ) ; and overall , 0.99 ( 0.84 - 1.17 ) . The overall RHs were similar after adjustment for potential confounders and differential use of statins between treatment groups ( RH , 0.97 ; 95 % CI , 0.82 - 1.14 ) , and in analyses restricted to women who were adherent to r and omized treatment assignment ( RH , 0.96 ; 95 % CI , 0.77 - 1.19 ) . CONCLUSIONS Lower rates of CHD events among women in the hormone group in the final years of HERS did not persist during additional years of follow-up . After 6.8 years , hormone therapy did not reduce risk of cardiovascular events in women with CHD . Postmenopausal hormone therapy should not be used to reduce risk for CHD events in women with CHD",
"Background —Although effects of statins on cardiovascular outcomes are well established in men , fewer data exist for women . Furthermore , the effects of statins plus hormone replacement therapy ( HRT ) on cardiovascular outcomes are uncertain . Methods and Results —We examined statin use , cardiovascular events , and total mortality in the Heart and Estrogen/progestin Replacement Study ( HERS ) , a r and omized clinical trial of estrogen plus progestin versus placebo in postmenopausal women with heart disease ( n=2763 ) . A nonr and omized comparison of statin users and nonusers revealed lower rates of the primary outcome , nonfatal myocardial infa rct ion or coronary heart disease death ( relative hazard [RH]=0.79 , 95 % confidence intervals [ CI ] 0.63 to 0.99 , P = 0.04 ) , and total mortality ( RH=0.67 , 95 % CI 0.51 to 0.87 , P = 0.003 ) . Rates of venous thromboembolic events were also lower among statin users ( RH=0.45 , 95 % CI 0.23 to 0.88 , P = 0.02 ) . HRT result ed in a significant increase in early risk for primary events in women who did not use statins ( RH=1.75 , 95 % CI 1.02 to 3.03 , P = 0.04 ) but not in statin users ( RH=1.34 , 95 % CI 0.63 to 2.86 , P = 0.45 ) . Adjustment for postr and omization statin use showed no effect of HRT on risk for the primary outcome ( RH=0.96 , 95 % CI 0.77 to 1.29;P = 0.72 ) . Conclusions —In HERS , statin use was associated with lower rates of cardiovascular events , venous thromboembolic events , and total mortality . These data provide strong support for statin use in eligible women with coronary disease",
"Context : The Women 's Health Initiative ( WHI ) r and omized controlled trial that compared estrogen plus progestin versus placebo was stopped because of a significantly increased risk of breast cancer in the active treatment group ( reason 1 ) , and because a global index supported a finding of overall harm ( reason 2 ) . The possibility that the findings could have been accounted for by bias was not considered . Objective : The present analysis was undertaken to determine whether detection bias is a plausible alternative to causality as an explanation for those findings that contributed to the reasons for discontinuing the study . Design , setting and participants : This work took the form of a sensitivity analysis of the published WHI data to determine the magnitude of the detection bias required to account for those findings that contributed to the two reasons for stopping the study . Main outcome measures : These were differences in incidence rates of breast cancer ( reason 1 ) , and breast cancer , coronary heart disease , stroke and pulmonary embolism ( reason 2 ) , among estrogen plus progestin and placebo recipients . Results In the WHI study , 44.4 % of the women on active treatment , as against 6.8 % of the placebo recipients , had their treatments unblinded ( mainly because of vaginal bleeding ) . Among them , detection bias could not be excluded . For the three cardiovascular outcomes , bias became a strong likelihood after the women were twice caution ed about possible increased risks observed in the interim data among estrogen plus progestin recipients . On the None hypothesis , bias could have accounted for the observed associations if , on average , it augmented the detection of disease that would otherwise have gone undiagnosed by 0.7 - 0.8/1000 per year . Conclusions : For differences in incidence of the order of 0.7 - 0.8/1000 per year , it is not possible to discriminate between causation and detection bias as alternative explanations for the findings",
"BACKGROUND Little is known about the impact of post-menopausal hormone therapy on remnant-like particle ( RLP ) concentrations and about the relationship between RLP concentration and angiographic progression of coronary artery disease and clinical events in women . METHODS RLP cholesterol and triglyceride levels were measured at baseline and 3 months after r and omization in 397 post-menopausal women enrolled in The Women 's Angiographic Vitamin & Estrogen ( WAVE ) trial . Correlates of baseline RLP levels and changes in levels with post-menopausal hormone therapy were determined with multiple linear regression . Coronary angiography was performed at baseline and after a mean of 2.9 years . Changes in minimal and average luminal diameter were modeled with multivariate linear regression , clinical outcomes ( non-fatal myocardial infa rct ion , stroke , or cardiovascular death ) with multiple logistic regression . RESULTS The mean subject age was 65 years , 66 % of subjects were white , 18 % of subjects smoked , most subjects were overweight or obese , and 35 % of subjects had diabetes mellitus . RLP cholesterol ( 0.277 + /- 0.254 mmol/L ) and triglyceride ( 0.386 + /- 0.552 mmol/L ) levels corresponded approximately to the 90th percentile in women in the Framingham study . RLP levels did not change significantly with hormone therapy . RLP levels at baseline , changes in RLP levels , and on treatment RLP levels did not relate to angiographic changes or clinical outcomes ( non-fatal myocardial infa rct ion , stroke , or cardiovascular death ) . CONCLUSIONS RLP levels were high among post-menopausal women enrolled in the WAVE study , were not affected by hormone therapy , and did not relate to angiographic progression of coronary artery disease or clinical outcomes",
"Context In observational studies , postmenopausal hormone therapy has been associated with lower fasting glucose levels . No prospect i ve , controlled trial has evaluated the effect of postmenopausal hormone therapy on the development of diabetes mellitus . Contribution Among the 2029 women in the Heart and Estrogen/progestin Replacement Study who had coronary disease but no diabetes at baseline , 6.2 % of those receiving 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate and 9.5 % of those receiving placebo developed diabetes . Implication s Recommendations about combination postmenopausal hormone therapy should consider that for every 30 women treated for 4 years , therapy might prevent one case of diabetes . The Editors Several clinical studies have evaluated the effect of postmenopausal hormone therapy on glucose metabolism and have had disparate results . Results from r and omized , controlled trials performed primarily in women without diabetes have found decreased mean fasting glucose or insulin levels among those assigned to hormone therapy ( 1 - 5 ) or no difference between those assigned to hormones and those assigned to placebo ( 6 - 10 ) . Fewer clinical trials have evaluated the effect of postmenopausal hormones on fasting glucose and insulin levels among women with type 2 diabetes mellitus , but again , the results have been mixed ( 11 - 16 ) . Observational studies have more consistently found that postmenopausal women taking hormone therapy have lower fasting glucose or hemoglobin A1c levels than those not taking hormones ( 17 - 24 ) . In addition , some ( 25 , 26 ) but not all ( 24 , 27 ) observational studies have noted a decreased incidence of diabetes among users of postmenopausal hormone therapy . No r and omized , controlled trial has evaluated the long-term effect of hormone therapy on diabetes incidence . To determine the effect of hormone therapy on subsequent diabetes , we analyzed data from the Heart and Estrogen/progestin Replacement Study ( HERS ) , in which 2763 postmenopausal women with documented coronary heart disease ( CHD ) were r and omly assigned to daily estrogen plus progestin therapy or to placebo . We evaluated the effect of hormone therapy on fasting glucose levels and incident diabetes over 4 years of follow-up . Methods Study Setting , Participants , and Design The design , methods , baseline characteristics ( 28 ) , and main findings ( 29 ) of HERS have been published elsewhere . Briefly , HERS was a r and omized , double-blind , placebo-controlled trial performed to evaluate daily doses of 0.625 mg of conjugated estrogen plus 2.5 mg of medroxyprogesterone acetate for the prevention of coronary events in postmenopausal women with established CHD . The trial enrolled 2763 women at 20 clinical centers in the United States between January 1993 and September 1994 and followed participants for a mean of 4.1 years . To be included in the trial , women had to be younger than 80 years of age and have CHD , as evidence d by previous myocardial infa rct ion , coronary artery bypass graft surgery , mechanical revascularization , or angiographic evidence of coronary stenosis . Women who reported a CHD event within 6 months of r and omization or who had used postmenopausal hormone therapy within 3 months of the initial screening were excluded . Those with serum triglyceride levels of 3.39 mmol/L or greater ( 300 mg/dL ) , fasting blood glucose levels of 16.5 mmol/L or greater ( 300 mg/dL ) , or uncontrolled hypertension ( systolic blood pres sure 200 mg Hg or diastolic blood pressure 105 mm Hg ) were also excluded . Computer-generated r and om numbers were used to specify the allocation sequence . Women were r and omly assigned to the two treatment groups by use of a tamper-proof blocked r and omization stratified by clinical center . Participants , investigators , and staff at the clinical centers ; Wyeth-Ayerst Research ; and those adjudicating study outcomes were blinded to medication assignment . Additional details about sample size calculations , r and omization , and blinding procedures have been published elsewhere ( 29 ) . For our analysis , women were classified as having diabetes at the baseline visit if they reported a physician diagnosis of diabetes , were taking diabetes medication , or had a fasting plasma glucose level of 6.9 mmol/L or greater ( 126 mg/dL ) . Women were classified as having impaired fasting glucose if they had a fasting glucose level of 6.0 to 6.9 mmol/L ( 110 to 125 mg/dL ) at baseline . The remaining women were considered to have normal glucose metabolism . Data Collection At baseline , participants completed a question naire to ascertain age , race or ethnicity , education , smoking habits ( current , former , or never ) , alcohol consumption ( drinks per week ) , and exercise or walking activity . Physical examination variables measured at baseline were body weight , height , waist and hip circumference , and systolic and diastolic blood pressure . At baseline , at year 1 , and at the end-of-trial visit , participants had fasting blood tests for levels of total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , and lipoprotein(a ) measured by the Lipoprotein Analytical Laboratory at Johns Hopkins Hospital , Baltimore , Maryl and . Fasting serum glucose level was measured at baseline , at year 1 , and at the end-of-trial visit . Venous blood was obtained in the morning after a 12-hour fast , and SmithKline Beecham Clinical Laboratory , Van Nuys , California , analyzed the sample s using the hexokinase enzymatic method . We determined coefficients of variation by using ChemTrac ( Medical Analysis Systems , Inc. , Camarillo , California ) control . The coefficient of variation for serum glucose level was 1.6 % at a mean value ( SD ) of 4.2 0.05 mmol/L ( 77 1.0 mg/dL ) and 1.1 % at a mean value ( SD ) of 14.6 0.16 mmol/L ( 266 3.0 mg/dL ) . Adherence to study medication was reassessed every 4 months , at each visit . Ascertainment of Outcomes Diabetes incidence was not a secondary end point of the main HERS trial , but blood glucose level was prespecified as a variable that may mediate the effects of hormone therapy on CHD outcomes . We defined incident cases of diabetes by the presence of a fasting glucose level of 6.9 mmol/L or greater ( 126 mg/dL ) at year 1 or at the end-of-trial visit , self-report of new diabetes or a complication directly related to diabetes , or initiation of hypoglycemic medication at any point during follow-up . Self-reported complications included diabetic neuropathy , diabetic retinopathy , diabetic foot ulcer , and diabetic renal disease . Hypoglycemia was considered a complication of diabetes if a participant taking an antidiabetic medication reported it to the study staff as an adverse event . Statistical Analysis To compare fasting glucose levels by treatment assignment at baseline , at year 1 , and at the end-of-trial visit , t-tests were used . In addition , mixed linear models for repeated measures were used to assess treatment effects on fasting glucose level measured at year 1 and at the end-of-trial visit . Since mean values changed little after the year 1 visit , treatment effects were modeled by using the interaction between treatment assignment and an indicator for follow-up compared with baseline . These analyses were repeated after stratification by baseline diabetes status ( diabetes , impaired fasting glucose , or normal glucose metabolism ) . We calculated the number needed to treat for benefit by taking the inverse of the absolute risk reduction of incident diabetes between the treatment groups . The effect of treatment assignment on incident diabetes was assessed by using Cox proportional-hazards models . Primary analyses used unadjusted intention-to-treat models ; in supplementary analyses , we adjusted first for age and then for a range of potential confounders selected a priori , including age ; ethnicity ; education ; current smoking ; alcohol use ; exercise ; body mass index ; waist circumference ; and baseline use of diuretics , -blockers , angiotensin-converting enzyme inhibitors , and statins . In addition to intention-to-treat analyses , we also performed as treated analyses to determine whether the observed effect of hormone therapy on glucose levels and incident diabetes was also seen among women who adhered to the study medication . In these analyses , follow-up was censored at the beginning of the first 2-week period in which participants did not adhere to medication . To minimize potential confounding , these analyses were adjusted for baseline variables that differed between adherent and nonadherent women . We hypothesized that certain characteristics ( body mass index , waist circumference , weight change , smoking , triglyceride level , high-density lipoprotein cholesterol level , hypertension , and certain cardiac medications ) may mediate the effect of hormone therapy on fasting glucose level and diabetes incidence . To test this theory , we added postr and omization values of one or more hypothesized mediators as covariates to Cox regression models for incident diabetes . All analyses were conducted by using SAS software , version 8.02 ( SAS Institute , Inc. , Cary , North Carolina ) . A P value less than 0.05 was considered statistically significant . Role of the Funding Sources The funding sources had no role in the design or conduct of this analysis or in the decision to su bmi t the paper for publication . Results Characteristics of women enrolled in HERS did not differ substantially between the hormone therapy group and the placebo group ( Table 1 ) . At the baseline examination , 734 women ( 26.6 % ) were classified as diabetic based on self-report of diagnosis or medication use ( n = 640 [ 87.2 % ] ) or by a fasting serum glucose level of 6.9 mmol/L or greater ( 126 mg/dL ) ( n = 101 [ 13.8 % ] ) . Impaired fasting glucose ( fasting serum glucose level , 6.0 to 6.9 mmol/L [ 110 to 125 mg/dL ] ) was noted in 218 women ( 7.9 % ) , and 1811 women ( 65.5 % ) were classified as nondiabetic ( Table 2 ) . Women with diabetes had higher body mass index , waist circumference ,",
"BACKGROUND Mammographic density is an independent risk factor for breast cancer . Postmenopausal hormone use is associated with an increase in mammographic density , but the magnitude of the density increase is unknown . METHODS Baseline and 12-month mammograms were obtained for 571 ( 65 % ) of the 875 women , aged 45 - 64 years , who were enrolled in the Postmenopausal Estrogen/Progestin Interventions Trial and r and omly assigned to receive placebo , daily conjugated equine estrogens at 0.625 mg/day ( CEE ) , daily CEE and medroxyprogesterone acetate ( MPA ) at 10 mg/day on days 1 - 12 ( CEE+MPA-cyclic ) , daily CEE and MPA at 2.5 mg/day ( CEE+MPA-continuous ) , or daily CEE and micronized progesterone ( MP ) at 200 mg/day on days 1 - 12 ( CEE+MP ) . We analyzed digitized mammograms to determine the percentage of the left breast that was composed of dense tissue ( i.e. , mammographic percent density ) . Linear regression analysis was used to examine the effects of treatments on the change in mammographic percent density between baseline and 12 months , before and after adjustment for possible confounders . All statistical tests were two-sided . RESULTS The adjusted absolute mean changes in mammographic percent density over 12 months were 4.76 % ( 95 % confidence interval [ CI ] = 3.29 % to 6.23 % ) , 4.58 % ( 95 % CI = 3.19 % to 5.97 % ) , and 3.08 % ( 95 % CI = 1.65 % to 4.51 % ) for women in the CEE+MPA-cyclic , CEE+MPA-continuous , and CEE-MP groups , respectively . Each of those absolute mean changes was statistically significantly different from the adjusted absolute mean change in mammographic percent density for women in the placebo group , which was -0.07 % ( 95 % CI = -1.50 % to 1.38 % ) . CONCLUSION Greater mammographic density was associated with the use of estrogen/progestin combination therapy , regardless of how the progestin was given , but not with the use of estrogen only",
"We examined whether estradiol and norethindrone hormone therapy ( HT ) prevented decline in delayed verbal recall in older women with normal to mildly impaired memory functioning . This was a 2-year , r and omized , double-blind , placebo-controlled trial of 142 women aged 61 - 87 , r and omly assigned to receive 1 mg 17-beta estradiol daily and 0.35 mg norethindrone 3 days/week or daily placebo for 2 years . The primary outcome was short-delay verbal recall of the California Verbal Learning Test ( CVLT ) . To look for differences in response to HT by baseline short-delay recall , we examined the primary outcome in participants grouped according to whether their baseline scores were below average for the age group or greater than or equal to this score and according to whether they met criteria for Mild Cognitive Impairment ( MCI ) or not . 133 women completed 1 year of the trial and 128 completed 2 years . Prespecified covariates in all repeated measures analyses of covariance ( RANCOVA ) included age , education , APOE epsilon4 , and prior HT use . RANCOVA showed no overall significant treatment effects at year 1 or year 2 . After testing for an interaction , which was significant ( p=0.02 ) , we found that women in the HT group who scored at or above the average showed significantly less decline than the placebo group in short-delay verbal recall after 1 year , p=0.007 and 2 years , p=0.01 . No treatment effects were found in women below the average in either year . When grouped according to whether the participant met criteria for MCI , the interaction between treatment group and MCI subgroup was not significant . These results suggest that benefits of estrogen exposure may be limited to those with average to above average scores on the delayed verbal recall . HT dose and formulation may have contributed to these beneficial outcomes . Replication is warranted before recommendations can be made in the clinical setting",
"BACKGROUND In the post-intervention period of the Women 's Health Initiative ( WHI ) trial , women assigned to treatment with oestrogen plus progestin had a higher risk of cancer than did those assigned to placebo . Results also suggested that the combined hormone therapy might increase mortality from lung cancer . To assess whether such an association exists , we undertook a post-hoc analysis of lung cancers diagnosed in the trial over the entire follow-up period . METHODS The WHI study was a r and omised , double-blind , placebo-controlled trial undertaken in 40 centres in the USA . 16 608 postmenopausal women aged 50 - 79 years with an intact uterus were r and omly assigned by a computerised , stratified , permuted block algorithm to receive a once-daily tablet of 0.625 mg conjugated equine oestrogen plus 2.5 mg medroxyprogesterone acetate ( n=8506 ) or matching placebo ( n=8102 ) . We assessed incidence and mortality rates for all lung cancer , small-cell lung cancer , and non-small-cell lung cancer by use of data from treatment and post-intervention follow-up periods . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00000611 . FINDINGS After a mean of 5.6 years ( SD 1.3 ) of treatment and 2.4 years ( 0.4 ) of additional follow-up , 109 women in the combined hormone therapy group had been diagnosed with lung cancer compared with 85 in the placebo group ( incidence per year 0.16%vs 0.13 % ; hazard ratio [ HR ] 1.23 , 95 % CI 0.92 - 1.63 , p=0.16 ) . 96 women assigned to combined therapy had non-small-cell lung cancer compared with 72 assigned to placebo ( 0.14%vs 0.11 % ; HR 1.28 , 0.94 - 1.73 , p=0.12 ) . More women died from lung cancer in the combined hormone therapy group than in the placebo group ( 73 vs 40 deaths ; 0.11%vs 0.06 % ; HR 1.71 , 1.16 - 2.52 , p=0.01 ) , mainly as a result of a higher number of deaths from non-small-cell lung cancer in the combined therapy group ( 62 vs 31 deaths ; 0.09%vs 0.05 % ; HR 1.87 , 1.22 - 2.88 , p=0.004 ) . Incidence and mortality rates of small-cell lung cancer were similar between groups . INTERPRETATION Although treatment with oestrogen plus progestin in postmenopausal women did not increase incidence of lung cancer , it increased the number of deaths from lung cancer , in particular deaths from non-small-cell lung cancer . These findings should be incorporated into risk-benefit discussion s with women considering combined hormone therapy , especially those with a high risk of lung cancer . FUNDING National Heart , Lung and Blood Institute , National Institutes of Health",
"The Women 's Angiographic Vitamin and Estrogen trial was a r and omized , double-blind , placebo-controlled study design ed to test the efficacy of estrogen replacement and antioxidant vitamins for preventing angiographic progression of coronary artery disease . Postmenopausal women with one or more angiographically documented coronary stenoses of 15 - 75 % at baseline were assigned in a 2 x 2 factorial r and omization to active hormone replacement therapy ( conjugated estrogens for women who had had a hysterectomy or conjugated estrogens with medroxyprogesterone for women with intact uteri ) or placebo and to active vitamins E and C or their placebos . Seven clinical centers , five in the United States and two in Canada , r and omized 423 women between July 1997 and July 1999 . Quantitative coronary angiography was performed at baseline and repeated after projected mean follow-up of 3 years",
"BACKGROUND Recent r and omized clinical trials have suggested that estrogen plus progestin does not confer cardiac protection and may increase the risk of coronary heart disease ( CHD ) . In this report , we provide the final results with regard to estrogen plus progestin and CHD from the Women 's Health Initiative ( WHI ) . METHODS The WHI included a r and omized primary -prevention trial of estrogen plus progestin in 16,608 postmenopausal women who were 50 to 79 years of age at base line . Participants were r and omly assigned to receive conjugated equine estrogens ( 0.625 mg per day ) plus medroxyprogesterone acetate ( 2.5 mg per day ) or placebo . The primary efficacy outcome of the trial was CHD ( nonfatal myocardial infa rct ion or death due to CHD ) . RESULTS After a mean follow-up of 5.2 years ( planned duration , 8.5 years ) , the data and safety monitoring board recommended terminating the estrogen-plus-progestin trial because the overall risks exceeded the benefits . Combined hormone therapy was associated with a hazard ratio for CHD of 1.24 ( nominal 95 percent confidence interval , 1.00 to 1.54 ; 95 percent confidence interval after adjustment for sequential monitoring , 0.97 to 1.60 ) . The elevation in risk was most apparent at one year ( hazard ratio , 1.81 [ 95 percent confidence interval , 1.09 to 3.01 ] ) . Although higher base-line levels of low-density lipoprotein cholesterol were associated with an excess risk of CHD among women who received hormone therapy , higher base-line levels of C-reactive protein , other biomarkers , and other clinical characteristics did not significantly modify the treatment-related risk of CHD . CONCLUSIONS Estrogen plus progestin does not confer cardiac protection and may increase the risk of CHD among generally healthy postmenopausal women , especially during the first year after the initiation of hormone use . This treatment should not be prescribed for the prevention of cardiovascular disease",
"OBJECTIVE To investigate the effect of pulsed estrogen therapy S21400 ( intranasal 17 beta-estradiol ) on different quality of life ( QoL ) dimensions in early postmenopausal women treated with S21400 150 microg per day , S21400 300 microg per day , or placebo in a double blind , r and omized , controlled 2-year study . STUDY DESIGN QoL was assessed based on the vali date d Women 's Health Question naire design ed for peri- and post-menopausal women . Three hundred and thirty-five healthy , early postmenopausal Danish women , 53 years of age in average , who completed one question naire at baseline and one under study treatment were included in the analysis set . All analyses were performed on an intention-to-treat basis . RESULTS QoL improved significantly in both S21400 groups compared to placebo in the dimensions ' memory/concentration ' , ' vasomotor symptoms ' , ' sleep problems ' and ' sexual behavior ' ( difference in mean change scores being respectively + 7.9 , + 28.3 , + 9.9 and + 10.8 % , p ' anxiety/depressed mood ' and ' well-being ' . CONCLUSION Pulsed estradiol therapy had a pronounced effect not only on vasomotor symptoms but also a significant and clinical ly relevant improvement in several other QoL dimensions ",
"The Heart and Estrogen/progestin Replacement Study ( HERS ) is a r and omized , double-blind , placebo-controlled trial design ed to test the efficacy and safety of estrogen plus progestin therapy for prevention of recurrent coronary heart disease ( CHD ) events in women . The participants are postmenopausal women with a uterus and with CHD as evidence d by prior myocardial infa rct ion , coronary artery bypass graft surgery , percutaneous transluminal coronary angioplasty , or other mechanical revascularization or at least 50 % occlusion of a major coronary artery . Between February 1993 and September 1994 , 20 HERS centers recruited and r and omized 2763 women . Participants ranged in age from 44 to 79 years , with a mean age of 66.7 ( SD 6.7 ) years . Most participants were white ( 89 % ) , married ( 57 % ) , and had completed high school or some college ( 80 % ) . As expected , the prevalence of coronary risk factors was high : 62 % were past or current smokers , 59 % had hypertension , 90 % had serum LDL-cholesterol of 100 mg/dL or higher , and 23 % had diabetes . Each woman was r and omly assigned to receive one tablet containing 0.625 mg conjugated estrogens plus 2.5 mg medroxyprogesterone acetate daily or an identical placebo . Participants will be evaluated every 4 months for an average of 4.2 years for the occurrence of CHD events ( CHD death and nonfatal myocardial infa rct ion ) . We will also assess other major CHD endpoints , including revascularization and hospitalization for unstable angina . The primary analysis will compare the rate of CHD events in women assigned to active treatment with the rate in those assigned to placebo . The trial was design ed to have power greater than 90 % to detect a 35 % reduction in the incidence of CHD events , assuming a 50 % lag in effect for 2 years and a 5 % annual event rate in the placebo group . The design , analysis , and conduct of the study are controlled by the Steering Committee of Principal Investigators and coordinated at the University of California , San Francisco . HERS is the largest trial of any intervention to reduce the risk of recurrent CHD events in women with heart disease and is the first controlled trial to seek evidence of the efficacy and safety of postmenopausal hormone therapy to prevent recurrent CHD events",
"CONTEXT Estrogen therapy is thought to promote gallstone formation and cholecystitis but most data derive from observational studies rather than r and omized trials . OBJECTIVE To determine the effect of estrogen therapy in healthy postmenopausal women on gallbladder disease outcomes . DESIGN , SETTING , AND PARTICIPANTS Two r and omized , double-blind , placebo-controlled trials conducted at 40 US clinical centers . The volunteer sample was 22,579 community-dwelling women aged 50 to 79 years without prior cholecystectomy . INTERVENTION Women with hysterectomy were r and omized to 0.625 mg/d of conjugated equine estrogens ( CEE ) or placebo ( n = 8376 ) . Women without hysterectomy were r and omized to estrogen plus progestin ( E + P ) , given as CEE plus 2.5 mg/d of medroxyprogesterone acetate ( n = 14,203 ) . MAIN OUTCOME MEASURES Participants reported hospitalizations for gallbladder diseases and gallbladder-related procedures , with events ascertained through medical record review . Cox proportional hazards regression was used to assess hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) using intention-to-treat and time-to-event methods . RESULTS The CEE and the E + P groups were similar to their respective placebo groups at baseline . The mean follow-up times were 7.1 years and 5.6 years for the CEE and the E + P trials , respectively . The annual incidence rate for any gallbladder event was 78 events per 10,000 person-years for the CEE group ( vs 47/10,000 person-years for placebo ) and 55 per 10,000 person-years for E + P ( vs 35/10,000 person-years for placebo ) . Both trials showed greater risk of any gallbladder disease or surgery with estrogen ( CEE : HR , 1.67 ; 95 % CI , 1.35 - 2.06 ; E + P : HR , 1.59 ; 95 % CI , 1.28 - 1.97 ) . Both trials indicated a higher risk for cholecystitis ( CEE : HR , 1.80 ; 95 % CI , 1.42 - 2.28 ; E + P : HR , 1.54 ; 95 % CI 1.22 - 1.94 ) ; and for cholelithiasis ( CEE : HR , 1.86 ; 95 % CI , 1.48 - 2.35 ; E + P : HR , 1.68 ; 95 % CI , 1.34 - 2.11 ) for estrogen users . Also , women undergoing estrogen therapy were more likely to receive cholecystectomy ( CEE : HR , 1.93 ; 95 % CI , 1.52 - 2.44 ; E + P : HR , 1.67 ; 95 % CI , 1.32 - 2.11 ) , but not other biliary tract surgery ( CEE : HR , 1.18 ; 95 % CI , 0.68 - 2.04 ; E + P : HR , 1.49 ; 95 % CI , 0.78 - 2.84 ) . CONCLUSIONS These data suggest an increase in risk of biliary tract disease among postmenopausal women using estrogen therapy . The morbidity and cost associated with these outcomes may need to be considered in decisions regarding the use of estrogen therapy",
"Background : Colorectal cancer incidence was reduced among women assigned to active treatment in the Women 's Health Initiative ( WHI ) estrogen plus progestin-r and omized trial , but the interpretation was obscured by an associated later stage of diagnosis . In contrast , the estrogen-alone trial showed no incidence reduction or differential stage at diagnosis . Here , data from the WHI observational study are considered , in conjunction with colorectal cancer mortality data from the hormone therapy trials , in an attempt to clarify postmenopausal hormone therapy effects . Participants and Methods : Postmenopausal women ages 50 to 79 years at WHI enrollment . Estrogen-alone analyses include 21,552 and 10,739 women who were posthysterectomy from the observational study and clinical trial , respectively . Estrogen plus progestin analyses include 32,084 and 16,608 observational study and clinical trial women with uterus . Colorectal cancers were verified by central medical and pathology report review . Results : Hazard ratios ( 95 % confidence intervals ) from the WHI observational study were 0.80 ( 0.53 - 1.20 ) for estrogen and 1.15 ( 0.74 - 1.79 ) for estrogen plus progestin , with , respectively , 168 and 175 women diagnosed with colorectal cancer . Delayed diagnosis with estrogen plus progestin is not evident in the observational study . No protective effect on colorectal cancer mortality in the estrogen plus progestin trial is seen over an 8-year intervention and follow-up period . Conclusion : Hazard ratio patterns in the WHI clinical trial and observational study do not provide strong evidence of a clinical ly important colorectal cancer benefit with either estrogen-alone or estrogen plus progestin over 7 to 8 years of treatment and follow-up . ( Cancer Epidemiol Biomarkers Prev 2009;18(5):1531–7",
"OBJECTIVE This study was undertaken to assess whether estrogen therapy ( ET ) reduces the risk of cognitive decline in women with cerebrovascular disease . STUDY DESIGN We conducted a r and omized , double-blind trial of estradiol 17beta versus placebo for secondary stroke prevention in 664 postmenopausal women with a recent stroke or transient ischemic attack . The Mini-Mental State Examination ( MMSE ) and 5 domain measures were obtained at baseline and exit . RESULTS Among 461 women withdrawn alive without stroke , ET did not have a significant effect on cognitive measures after an average of 3 years ( relative risk of MMSE decline : 0.74 , 95 % CI , 0.49 - 1.13 ) . In women with normal MMSE at entry , estrogen was associated with less decline ( relative risk , 0.46 , 95 % CI , 0.24 - 0.87 ) . CONCLUSION In this study , estradiol did not have significant effects on cognitive measures . However , in women with normal function at baseline , there may be a benefit for ET in reducing the risk for cognitive decline",
"Postmenopausal hormone therapy is widely used to prevent diseases . This is not , however , based on the kind of evidence that is normally required of a preventive drug therapy : it is based on intermediary outcomes of trials and non-experimental studies . Many reasons can be postulated for the fact that we know little of this old and widely used therapy . To remedy the current situation , we should encourage r and omised controlled trials , reveal the insufficiency of the current evidence , and challenge the drug industry 's biased influence",
"Over the last 40 years , there has been increasing epidemiological evidence that post-menopausal treatment with sex steroids in physiological doses may reduce the relative risk of cardiovascular disease ( CVD ) . These findings have been supported by biological studies showing favourable changes in cardiovascular risk factors with estrogen supplementation . The impact of the so-called ' healthy user ' bias has been eagerly debated , and the results of the first and only r and omized long-term clinical trial of HRT for primary prevention have therefore been long awaited . The dramatic decision to halt the Women 's Health Initiative ( WHI ) study before completion came unexpectedly as the consequence of not only an increased risk of breast cancer but also increased occurrence of cardiovascular events with HRT . Due to the superior design of the study , the results from the WHI study have had an enormous impact on the clinical recommendations of HRT to post-menopausal women , concurrent with a degradation of evidence from observational studies . It is not very likely that other long-term r and omized clinical trials ( RCTs ) will be completed and epidemiology has certainly been disreputed-so is this ' time out ' for HRT studies",
"OBJECTIVE : To estimate the effects of estrogen plus progestin ( E+P ) therapy on menopausal symptoms , vaginal bleeding , gynecologic surgery rates , and treatment-related adverse effects in postmenopausal women . METHODS : R and omized , double-blind , placebo-controlled trial of 16,608 postmenopausal women , ages 50–79 ( mean ± st and ard deviation 63.3 ± 7.1 ) years , with intact uterus , r and omized to one tablet per day containing 0.625 mg conjugated equine estrogens plus 2.5 mg medroxyprogesterone acetate ( n = 8,506 ) or placebo ( n = 8,102 ) , and followed for a mean of 5.6 years . Change in symptoms and treatment-related effects were analyzed at year 1 in all participants . Bleeding and gynecologic surgery rates were analyzed through study close-out . RESULTS : Baseline symptoms did not differ between the treatment groups . More women assigned to E+P than placebo reported relief of hot flushes ( 85.7 % versus 57.7 % , respectively ; odds ratio 4.40 ; 95 % confidence interval 3.40–5.71 ) , night sweats ( 77.6 % versus 57.4 % ; 2.58 ; 2.04–3.26 ) , vaginal or genital dryness ( 74.1 % versus 54.6 % ; 2.40 ; 1.90–3.02 ) , joint pain or stiffness ( 47.1 % versus 38.4 % ; 1.43 ; 1.24–1.64 ) , and general aches or pains ( 49.3 % versus 43.7 % ; 1.25 ; 1.08–1.44 ) . Women asymptomatic at baseline who were assigned to E+P more often developed breast tenderness ( 9.3 % versus 2.4 % , respectively ; 4.26 ; 3.59–5.04 ) , vaginal or genital discharge ( 4.1 % versus 1.0 % ; 4.47 ; 3.44–5.81 ) , vaginal or genital irritation ( 4.2 % versus 2.8 % ; 1.52 ; 1.27–1.81 ) , and headaches ( 5.8 % versus 4.7 % ; 1.26 ; 1.08–1.46 ) than women on placebo . Estrogen plus progestin treatment prevented the onset of new musculoskeletal symptoms . Vaginal bleeding was reported by 51 % of women on E+P and 5 % of women on placebo at 6 months ; most bleeding was reported as spotting . Gynecologic surgeries ( hysterectomy and dilation and curettage ) were performed more frequently in women assigned to E+P ( 3.1 % versus 2.5 % for hysterectomy , hazard ratio = 1.23 , P = .026 ; 5.4 % versus 2.4 % for dilation and curettage , hazard ratio = 2.23 , P vasomotor symptoms and vaginal or genital dryness , but contributed to treatment-related effects , such as bleeding , breast tenderness , and an increased likelihood of gynecologic surgery . LEVEL OF EVIDENCE :",
"BACKGROUND Postmenopausal hormone therapy has been associated with a 2- to 3-fold increased risk of venous thromboembolism ( VT ) ( including deep vein thrombosis and pulmonary embolism ) in observational studies and secondary prevention clinical trials . Clinical trial data on the effects of estrogen alone on VT are limited . METHODS The Women 's Health Initiative estrogen trial enrolled 10 739 women aged 50 to 79 years without a uterus . Participants were r and omly assigned to receive conjugated equine estrogen ( 0.625 mg/d ) or placebo . RESULTS During a mean of 7.1 years , VT occurred in 111 women r and omly assigned to receive estrogen ( 3.0 per 1000 person-years ) and 86 r and omly assigned to receive placebo ( 2.2 per 1000 person-years ; hazard ratio , 1.32 ; 95 % confidence interval , 0.99 - 1.75 ) . Deep venous thrombosis was reported in 85 women r and omly assigned to receive estrogen ( 2.3 per 1000 person-years ) and 59 r and omly assigned to receive placebo ( 1.5 per 1000 person-years ; hazard ratio , 1.47 ; 95 % confidence interval , 1.06 - 2.06 ) . The VT risk was highest in the first 2 years . There were no significant interactions between estrogen use and age , body mass index , or most other VT risk factors . Comparison of Women 's Health Initiative VT findings for estrogen and previous Women 's Health Initiative findings for estrogen plus progestin showed that the hazard ratios for estrogen plus progestin were significantly higher than those for estrogen alone ( P = .03 ) , even after adjusting for VT risk factors . CONCLUSION An early increased VT risk is associated with use of estrogen , especially within the first 2 years , but this risk increase is less than that for estrogen plus progestin",
"BACKGROUND In the Women 's Health Initiative ( WHI ) r and omized controlled trial , use of estrogen plus progestin increased lung cancer mortality . We conducted post hoc analyses in the WHI trial evaluating estrogen alone to determine whether use of conjugated equine estrogen without progestin had a similar adverse influence on lung cancer . METHODS The WHI study is a r and omized , double-blind , placebo-controlled trial conducted in 40 centers in the United States . A total of 10 739 postmenopausal women aged 50 - 79 years who had a previous hysterectomy were r and omly assigned to receive a once-daily 0.625-mg tablet of conjugated equine estrogen ( n = 5310 ) or matching placebo ( n = 5429 ) . Incidence and mortality rates for all lung cancers , small cell lung cancers , and non-small cell lung cancers in the two r and omization groups were compared by use of hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) that were estimated from Cox proportional hazards regression analyses . Analyses were by intention to treat , and all statistical tests were two-sided . RESULTS After a mean of 7.9 years ( st and ard deviation = 1.8 years ) of follow-up , 61 women in the hormone therapy group were diagnosed with lung cancer compared with 54 in the placebo group ( incidence of lung cancer per year = 0.15 % vs 0.13 % , respectively ; HR of incidence = 1.17 , 95 % CI = 0.81 to 1.69 , P = .39 ) . Non-small cell lung cancers were of comparable number , stage , and grade in both groups . Deaths from lung cancer did not differ between the two groups ( 34 vs 33 deaths in estrogen and placebo groups , respectively ; HR of death = 1.07 , 95 % CI = 0.66 to 1.72 , P = .79 ) . CONCLUSION Unlike use of estrogen plus progestin , which increased deaths from lung cancer , use of conjugated equine estrogen alone did not increase incidence or death from lung cancer",
"Despite several observational studies , 1–3 no clinical trial has evaluated the effect of hormone therapy on percutaneous transluminal coronary angioplasty ( PTCA ) outcomes in matched population s r and omized to hormones or placebo . We compared the incidence of coronary heart disease ( CHD ) events after PTCA among women who previously had been r and omly assigned to hormone therapy and placebo in the Heart and Estrogen/progestin Replacement Study ( HERS ) . The design , methods , and primary results of HERS have been previously published . 4,5 Briefl y , HERS participants were postmenopausal women aged 80 years with established CHD who had not had a hysterectomy . Inclusion criteria were prior myocardial infa rct ion , coronary artery bypass graft surgery ( CABG ) , PTCA , or angiographic evidence of a 50 % diameter narrowing of 1 major coronary artery . Exclusion criteria were a recent CHD event , New York Heart Association class IV or severe class III congestive heart failure , serum triglyceride levels 300 mg/ dl , recent use of any hormone therapy , uncontrolled hypertension or diabetes , a disease ( other than CHD ) judged likely to be fatal within 4 years , or prior intolerance to hormone therapy . At the initiation of the HERS , participants were r and omly assigned to receive a single identical tablet containing either conjugated equine estrogen 0.625 mg and medroxyprogesterone acetate 2.5 mg or placebo . During the HERS , 357 patients underwent PCTA and constituted the study population . These patients were followed subsequently to ascertain their rate for subsequent CHD events . Demographic characteristics , health history , CHD risk factors , medication use , educational level , and quality of life were assessed at baseline . Baseline levels of fasting total cholesterol , low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , triglycerides , and lipoprotein ( a ) were determined by the Lipoprotein Analytical Laboratory at Johns Hopkins Hospital ( Baltimore , Maryl and ) . Follow-up time for this analysis began at the time of the initial PTCA and concluded at the closeout of the HERS . All suspected outcome events were classifi ed independently by 2 physician review ers who were unaware of treatment assignment . Discordant classifi cations were resolved in discussion s between the review ers",
"Objective : To investigate factors associated with the presence , severity , and frequency of hot flushes . Design : A 9-year prospect i ve study of 438 Australian-born women , aged 45 to 55 years and menstruating at baseline . Annual fasting blood collection , physical measurements , and interviews including questions about bothersome hot flushes in previous 2 weeks were performed . A “ hot flush index ” score was calculated from the product of the severity and frequency data . Data were analyzed using r and om-effects time-series regression models . Results : A total of 381 women supplied complete data over the follow-up years . A total of 350 women experienced the menopause transition , of whom 60 ( 17 % ) never reported bothersome hot flushes . At baseline , women who reported hot flushes were significantly more likely to have higher negative moods , not be in full- or part-time paid work , smoke , and not report exercising every day . Over the 9-year period of the study , variables significantly associated with reporting bothersome hot flushes were relatively young age ( P low exercise levels ( P low estradiol levels ( P follicle-stimulating hormone ( FSH ) levels ( P smoking ( P the late menopause transition ( P postmenopausal ( P hot flush index score increased as their FSH levels increased ( P age ( P exercise level ( P hot flush index score was greater in women with higher average FSH levels over time ( P FSH and estradiol levels , age , exercise level , and smoking status all contributed to the experience of bothersome hot flushes",
"OBJECTIVE To assess the efficacy of unopposed estrogen , and three estrogen/progestin regimens on selected heart disease risk factors among adherent women and to contrast those results with efficacy among all women in the PEPI study . DESIGN A 3-year , multicenter , r and omized , double-blinded , placebo-controlled clinical trial . PARTICIPANTS A total of 847 healthy postmenopausal women aged 45 to 64 years of age with no known contraindication to hormone therapy , who attended their 36 month clinical visit . INTERVENTION Participants were r and omized in equal numbers to one of the following treatments : ( 1 ) placebo ; ( 2 ) conjugated equine estrogen ( CEE ) 0.625 mg daily ; ( 3 ) CEE 0.625 daily plus medroxyprogesterone acetate ( MPA ) 10 mg , days 1 - 12 ; ( 4 ) CEE 0.625 daily plus MPA 2.5 mg daily ; or ( 5 ) CEE 0.625 daily plus micronized progesterone ( MP ) 200 mg , days 1 - 12 . ANALYSIS Analyses are based on adherent women , where adherence is defined as taking at least 80 % of pills at each 6-month visit . RESULTS Adherence rates were high in all groups except women with a uterus assigned to unopposed CEE . The difference in HDL-C levels result ing from the CEE vs. CEE+MP was approximately three times larger than in the intent-to-treat analyses , reaching statistical significance ( P LDL-C decreased 10 - 15 % . Triglycerides increased 15 - 20 % in each opposed CEE arm and over 25 % in the CEE only arm ; this difference was not statistically significant . Fibrinogen increased by 7 % among placebo adherers , but decreased or remained fairly stable among the active arm adherers . Systolic blood pressure increased 3 - 5 % in all treatment arms . Women adherent to the CEE+MPA arms had twice the increase of 2 h glucose levels as women adherent to CEE only , or CEE+MP ( 8 - 9 % vs. 3 - 4 % ) . Two-hour insulin levels decreased 3 - 12 % for all arms . The patterns of change for fibrinogen , SBP , 2 h glucose and insulin were similar to those from the intent-to-treat analyses . CONCLUSIONS In analyses limited to adherent women , all active treatments , compared to placebo , continued to have similar and favorable effects on LDL-cholesterol and fibrinogen and no significant effects on blood pressure or insulin levels . Given the overall high adherence rates in PEPI , the results are similar to the intent-to-treat analyses , as expected . Only the trend of HDL-C to have a larger increase in the CEE only arm ( in the intent-to-treat analyses ) gained statistical significance in analyses restricted to adherers",
"BACKGROUND AND PURPOSE Observational studies have found that women who take estrogen after menopause are less likely to have a stroke than women who do not take estrogen . Although these findings indicate that estrogen may prevent stroke , an alternative explanation for the improved outcome of estrogen users is that they are healthier before starting therapy than nonusers . To test the therapeutic effect of estrogen with research methods that avoid this selection bias , we design ed a r and omized controlled trial . TRIAL DESIGN The Women 's Estrogen For Stroke Trial ( WEST ) is a double-blind , r and omized trial with a primary goal of determining whether 1 mg 17beta-estradiol daily , when compared with placebo , reduces the risk of recurrent stroke or death among postmenopausal women who have experienced a transient ischemic attack or nondisabling ischemic stroke . Exclusion criteria include use of estrogen at the time of stroke , breast or uterine cancer , inability to speak English , and estimated survival less than 5 years . Once r and omized , women remain under the care of their personal physicians for management of stroke risk factors . For early detection of endometrial hyperplasia and cancer , asymptomatic women receive medroxyprogesterone yearly ( 5 mg for 12 days ) and vaginal ultrasonography or biopsy at the end of the trial . Unscheduled uterine bleeding is evaluated with biopsy . A total of 652 women are sought at 20 hospitals in Connecticut and one in Massachusetts . CONCLUSIONS The WEST promises to provide critical guidance to women and their physicians regarding the effectiveness of estrogen in secondary stroke prevention",
"CONTEXT Observational studies have suggested that postmenopausal hormone treatment may improve cognitive function , but data from r and omized clinical trials have been sparse and inconclusive . The Women 's Health Initiative Memory Study ( WHIMS ) is an ancillary study of the Women 's Health Initiative ( WHI ) hormone therapy trials . On July 8 , 2002 , the estrogen plus progestin therapy in the WHI trial was discontinued because of certain increased health risks for women . OBJECTIVE To determine whether estrogen plus progestin therapy protects global cognitive function in older postmenopausal women . DESIGN , SETTING , AND PARTICIPANTS A r and omized , double-blind , placebo-controlled clinical trial , WHIMS is an ancillary study of geographically diverse , community-dwelling women aged 65 years or older from 39 of 40 clinical centers within the WHI estrogen plus progestin trial that started in June 1995 . Of 4894 eligible postmenopausal women aged 65 years or older and free of probable dementia at baseline , 4532 ( 92.6 % ) were enrolled in the estrogen plus progestin component of WHIMS . A total of 4381 participants ( 96.7 % ) provided at least 1 valid cognitive function score between June 1995 and July 8 , 2002 . INTERVENTIONS Participants received either 1 daily tablet containing 0.625 mg of conjugated equine estrogen with 2.5 mg of medroxyprogesterone acetate ( n = 2145 ) or matching placebo ( n = 2236 ) . MAIN OUTCOME MEASURE Global cognitive function measured annually with the Modified Mini-Mental State Examination . RESULTS The Modified Mini-Mental State Examination mean total scores in both groups increased slightly over time ( mean follow-up of 4.2 years ) . Women in the estrogen plus progestin group had smaller average increases in total scores compared with women receiving placebo ( P = .03 ) , but these differences were not clinical ly important . Removing women by censoring them after adjudicated dementia , mild cognitive impairment , or stroke , and nonadherence to study protocol , did not alter the findings . Prior hormone therapy use and duration of prior use did not affect the interpretation of the results , nor did timing of prior hormone therapy initiation with respect to the final menstrual period . More women in the estrogen plus progestin group had a substantial and clinical ly important decline ( > or = 2 SDs ) in Modified Mini-Mental State Examination total score ( 6.7 % ) compared with the placebo group ( 4.8 % ) ( P = .008 ) . CONCLUSIONS Among postmenopausal women aged 65 years or older , estrogen plus progestin did not improve cognitive function when compared with placebo . While most women receiving estrogen plus progestin did not experience clinical ly relevant adverse effects on cognition compared with placebo , a small increased risk of clinical ly meaningful cognitive decline occurred in the estrogen plus progestin group",
"PURPOSE To determine if hormone therapy results in better cognitive function in older postmenopausal women . SUBJECTS AND METHODS The Heart and Estrogen/progestin Replacement Study ( HERS ) was a r and omized , placebo-controlled trial involving 2763 women with coronary disease . Women were assigned r and omly to conjugated estrogen ( 0.625 mg ) plus medroxyprogesterone acetate ( 2.5 mg ) in one tablet daily or identical placebo ; they were followed for a mean ( + /- SD ) of 4.2 + /- 0.4 years . Participants at 10 of the 20 HERS centers were invited to enroll in the cognitive function sub study . At the end of the trial , we measured cognitive function in 517 women in the hormone group and 546 in the placebo group using six st and ard tests : the modified Mini-Mental Status Examination , Verbal Fluency , Boston Naming , Word List Memory , Word List Recall , and Trails B. Cognitive function was not measured at baseline . RESULTS The mean age of participants at the time of cognitive function testing was 71 + /- 6 years . There were no differences in age-adjusted cognitive function test scores between the two treatment groups , except that women assigned to hormones scored worse on the Verbal Fluency test than women assigned to placebo ( 15.9 + /- 4.8 vs. 16.6 + /- 4.8 , P = 0.02 ) . Adjustment for other potential confounders and restriction of the analyses to women who had been adherent to study medication did not change the results . CONCLUSION Among older postmenopausal women with coronary disease , 4 years of treatment with postmenopausal hormone therapy did not result in better cognitive function as measured on six st and ardized tests . Whether these results also apply to elderly women without coronary disease can not be determined from this study",
"OBJECTIVES To assess the extent to which prior hormone therapy modifies the breast cancer risk found with estrogen plus progestin ( E+P ) in the Women 's Health Initiative ( WHI ) r and omized trial . METHODS Subgroup analyses of prior hormone use on invasive breast cancer incidence in 16,608 postmenopausal women in the WHI r and omized trial of E+P over an average 5.6 years of follow-up . RESULTS Small but statistically significant differences were found between prior HT users and non-users for most breast cancer risk factors but Gail risk scores were similar . Duration of E+P use within the trial ( mean 4.4 years , S.D. 2.0 ) did not vary by prior use . Among 4311 prior users , the adjusted hazard ratio ( HR ) for E+P versus placebo was 1.96 ( 95 % confidence interval [ CI ] : 1.17 - 3.27 ) , significantly different ( p=0.03 ) from that among 12,297 never users ( HR 1.02 ; 95 % CI : 0.77 - 1.36 ) . The interaction between study arm and follow-up time was significant overall ( p=0.01 ) and among never users ( p=0.02 ) but not among prior users ( p=0.10 ) . The cumulative incidence over time for the E+P and placebo groups appeared to cross after about 3 years in prior users , and after about 5 years in women with no prior use . No interaction was found with duration ( p=0.08 ) or recency of prior use ( p=0.17 ) . Prior hormone use significantly increased the E+P hazard ratio for larger , more advanced tumors . CONCLUSION A safe interval for combined hormone use could not be reliably defined with these data . However , the significant increase in breast cancer risk in the trial overall after only 5.6 years of follow-up , initially concentrated in women with prior hormone exposure , but with increasing risk over time in women without prior exposure , suggests that duration s only slightly longer than those in the WHI trial are associated with increased risk of breast cancer . Longer-term exposure and follow-up data are needed"
] | 4116327e-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND A geriatric assessment ( GA ) is increasingly used to help guide treatment decisions in older patients with cancer . However , there is no consensus regarding which domains should be included in the GA . In addition , the field of geriatric oncology moves very fast and as a result many new studies have been published since the last review in 2015 . Therefore , the objective of this systematic review is to evaluate which domains of the GA could predict patient-related treatment outcomes of older patients with cancer and thereby should be included in a GA . METHODS A systematic literature search was performed for publications in English or Dutch between September 2006 and July 2017 addressing the association between individual domains of the GA and mortality , postoperative complications , or systemic treatment-related outcomes in older patients with cancer . RESULTS Eight different domains were evaluated in 46 publications , namely functional status , nutritional status , cognition , mood , physical function , fatigue , social support , and falls . All eight domains were predictive for at least one of the investigated outcomes but the results were quite variable across studies . Physical function and nutritional status were the domains most often associated with mortality and systemic treatment-related outcomes , and the domain physical function was most often associated with postoperative complications . CONCLUSION Overall , this review demonstrates that the GA should minimally consist of physical function and nutritional status , when the aim is to predict patients -related outcomes of older patients with cancer , although the results are quite heterogeneous . For the other domains , the findings are too inconsistent to draw conclusions about their overall predictive ability | [
"Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items",
"Objective Cancer is one of the most common diagnoses in elderly patients . Of all types of abdominal cancer , colorectal cancer ( CRC ) is undoubtedly the most frequent . Median age at diagnosis is approximately 70 years old worldwide . Due to the multiple comorbidities affecting elderly people , frailty evaluation is very important in order to avoid over- or under-treatment . This pilot study was design ed to investigate the variables capable of predicting the long-term risk of mortality and living situation after surgery for CRC . Methods Patients with 70 years old and older undergoing elective surgery for CRC were prospect ively enrolled in the study . The patients were preoperatively screened using 11 internationally-vali date d-frailty- assessment tests . The endpoints of the study were long-term mortality and living situation . The data were analyzed using univariate Cox proportional-hazard regression analysis to verify the predictive value of score indices in order to identify possible risk factors . Results Forty-six patients were studied . The median follow-up time after surgery was 4.6 years ( range , 2.9 - 5.7 years ) and no patients were lost to follow-up . The overall mortality rate was 39 % . Four of the patients who survived ( 4/28 , 14 % ) lost their functional autonomy . The preoperative impaired Timed Up and Go ( TUG ) , Eastern Cooperative Group Performance Status ( ECOG PS ) , Instrumental Activities of Daily Living ( IADLs ) , Vulnerable Elders Survey ( VES-13 ) scoring systems were significantly associated with increased long term mortality risk . Conclusion Simplified frailty-assessing tools should be routinely used in elderly cancer patients before treatment in order to stratify patient risk . The TUG , ECOG-PS , IADLs and VES-13 scoring systems are potentially able to predict long-term mortality and disability . Additional studies will be needed to confirm the preliminary data in order to improve management strategies for oncogeriatric surgical patients",
"BACKGROUND Screening tools are used in geriatric oncology to determine who should receive a Comprehensive Geriatric Assessment ( CGA ) . However , in this prospect i ve study , we evaluated the association between geriatric screening results , measured with the G8 and Groningen Frailty Indicator ( GFI ) , and severe treatment toxicity . METHODS Patients over 65 years with various types and stages of cancer were screened with the G8 and the GFI prior to the start of treatment . The association between geriatric screening results and Serious Adverse Events ( SAE ) after the first cycle of (radio)chemotherapy were studied with bivariate analysis ( normal versus abnormal screening test ) and logistic regression analysis . RESULTS From 170 screened patients , 85 patients were eligible for this study . The median age was 76 years ( range : 66 - 88 years ) . The treatment intent was curative in 46 % and palliative in 54 % . A SAE occurred in 15 patients ( 18 % ) of which three result ed in death . There was no significant association between the G8 , as a dichotomous predictor ( p = 0.376 ) or as a continuous predictor ( p = 0.298 ) , and risk of a SAE . We also found no significant association for the GFI analysed as a dichotomous predictor ( cut-off ≥4 : p = 0.384 ; cut-off ≥3 : p = 0.773 ) , nor as a continuous predictor ( p = 0.734 ) . All associations remained insignificant when adjusted for treatment type and comorbidity . CONCLUSION The G8 and the GFI can be used to select patients for CGA , but they do not seem to be predictive for short-term severe treatment toxicity",
"Chemotherapy is associated with toxicity in elderly patients with potentially curable malignancies , posing the dilemma of whether to intensify therapy , thereby improving the cure rate , or de-escalate therapy , thereby reducing toxicity , with consequent risks for under- or overtreatment . Adequate tools to define doses and combinations have not been identified for lymphoma patients . We conducted a prospect i ve trial aim ed to evaluate the feasibility and efficacy of chemotherapy modulated according to a modified comprehensive geriatric assessment ( CGA ) in elderly ( aged ≥70 years ) patients with diffuse large B-cell lymphoma ( DLBCL ) . In June 2000 to March 2006 , 100 patients were stratified using a CGA into three groups ( fit , unfit , and frail ) , and they received a rituximab plus cyclophosphamide , doxorubicin , vincristine , and prednisone modulated in dose and drugs according to comorbidities and activities of daily living ( ADL ) and instrumental ADL scores . Treatment was associated with a complete response rate of 81 % and mild toxicity : grade 4 neutropenia in 14 % , anemia in 1 % , and neurological and cardiac toxicity in 2 % of patients . At a median follow-up of 64 months , 51 patients were alive , with 5-year disease-free , overall , and cause-specific survival rates of 80 % , 60 % , and 74 % , respectively . Chemoimmunotherapy adjustments based on a CGA are associated with manageable toxicity and excellent outcomes in elderly patients with DLBCL . Wide use of this CGA-driven treatment may result in better cure rates , especially in fit and unfit patients",
"Objective To determine the predictive value of the “ Timed Up & Go ” ( TUG ) , a vali date d assessment tool , on a prospect i ve cohort study and to compare these findings to the ASA classification , an instrument commonly used for quantifying patients ’ physical status and anesthetic risk . Background In the onco-geriatric surgical population it is important to identify patients at increased risk of adverse post-operative outcome to minimize the risk of over- and under-treatment and improve outcome in this population . Methods 263 patients ≥70 years undergoing elective surgery for solid tumors were prospect ively recruited . Primary endpoint was 30-day morbidity . Pre-operatively TUG was administered and ASA-classification was registered . Data were analyzed using multivariable logistic regression analyses to estimate odds ratios ( OR ) and 95 % confidence intervals ( 95%-CI ) . Absolute risks and area under the receiver operating characteristic curves ( AUC ’s ) were calculated . Results 164 ( 62.4 % ) patients ( median age : 76 ) underwent major surgery . 50 ( 19.5 % ) patients experienced major complications . 50.0 % of patients with high TUG and 24.8 % of patients with ASA≥3 experienced major complications ( absolute risks ) . TUG and ASA were independent predictors of the occurrence of major complications ( TUG : OR 3.43 ; 95%-CI = 1.13–10.36 . ASA1 vs. 2:OR 5.67 ; 95%-CI = 0.86–37.32 . ASA1 vs. 3&4:OR 11.75 ; 95%-CI = 1.62–85.11 ) . AUCTUG was 0.66 ( 95%-CI = 0.57–0.75 , p ) and AUCASA was 0.58 ( 95%-CI = 0.49–0.67 , p = 0.09 ) . Conclusions Twice as many onco-geriatric patients at risk of post-operative complications , who might benefit from pre-operative interventions , are identified using TUG than when using ASA",
"Background In the general geriatric population , programs linking geriatric evaluation with interventions are effective for improving functional status and survival of the patients . Whether or not these interventions improve health related quality of life ( HRQoL ) or overall survival ( OS ) in older patients with cancer is not yet clear . Indeed , r and omized data on the effect of such interventions on survival and HRQoL are rare and conflicting . We describe the rationale and design of a phase III multicenter trial aim ed at assessing the efficacy of geriatric intervention in the management of elderly patients with cancer . Methods / design Approximately 1200 patients , 70 years and older , considered in need of a geriatric intervention based on the G8 screening tool will be r and omized into two intervention arms . The ‘ Usual-care ’ arm involves st and ard oncological care based on pre-defined oncological protocol s. In addition to the st and ard oncological care , the ‘ Case-management ’ arm involves a multidimensional geriatric assessment and interventions tailored for the patient . Efficacy will be assessed using a co- primary endpoint encompassing OS and HRQoL. Discussion This trial has been design ed to assess whether focused geriatric case management can either improve OS or HRQoL in elderly cancer patients considered in need of geriatric assessment .Trial registration Clinical trials.gov ID : NCT02704832",
"AIMS The aim of this study was to investigate the predictive ability of screening tools regarding the occurrence of major postoperative complications in onco-geriatric surgical patients and to propose a scoring system . METHODS 328 patients ≥ 70 years undergoing surgery for solid tumors were prospect ively recruited . Preoperatively , twelve screening tools were administered . Primary endpoint was the incidence of major complications within 30 days . Odds ratios ( OR ) and 95 % confidence intervals ( 95 % CI ) were estimated using logistic regression . A scoring system was derived from multivariate logistic regression analysis . The area under the receiver operating characteristic curve ( AUC ) was applied to evaluate model performance . RESULTS At a median age of 76 years , 61 patients ( 18.6 % ) experienced major complications . In multivariate analysis , Timed Up and Go ( TUG ) , ASA-classification and Nutritional Risk Screening ( NRS ) were predictors of major complications ( TUG>20 OR 3.1 , 95 % CI 1.1 - 8.6 ; ASA ≥ 3 OR 2.8 , 95 % CI 1.2 - 6.3 ; NRS impaired OR 3.3 , 95 % CI 1.6 - 6.8 ) . The scoring system , including TUG , ASA , NRS , gender and type of surgery , showed good accuracy ( AUC : 0.81 , 95 % CI 0.75 - 0.86 ) . The negative predictive value with a cut-off point > 8 was 93.8 % and the positive predictive value was 40.3 % . CONCLUSIONS A substantial number of patients experience major postoperative complications . TUG , ASA and NRS are screening tools predictive of the occurrence of major postoperative complications and , together with gender and type of surgery , compose a good scoring system",
"BACKGROUND Geriatric assessment has been suggested as a possibly useful approach in dealing with frail elderly cancer patients . METHODS This was a secondary subset analysis from a r and omized 2 x 2 factorial trial in 11 Department of Veterans Affairs medical centers . Hospitalized , frail patients at least 65 years old , after stabilization of their acute illness , were r and omized to receive care in a geriatric inpatient unit , a geriatric outpatient clinic , both , or neither . The interventions involved core teams that provided geriatric assessment and patient management . We identified 99 patients with a diagnosis of cancer by The International Classification of Diseases , 9th Revision ( ICD-9 ) codes , excluding all nonmelanoma skin cancers . Outcomes collected at discharge , 6 months , and 1 year after r and omization were survival , changes in health-related quality of life ( using the Medical Outcomes Study 36-Item Short-Form general health survey [ SF-36 ] ) , activities of daily living , physical performance , health service utilization , and costs . RESULTS There was no effect on mortality ( 1-year survival 59.6 % ) . The changes in the SF-36 scores from r and omization for emotional limitation , mental health and bodily pain ( also sustained at 1 year ) on the SF-36 were better for geriatric inpatient care cancer patients at discharge . There was no difference in SF-36 scores between geriatric outpatient and usual outpatient care . Days of hospitalization and overall costs were equivalent for the interventions and usual care over the 1-year study . CONCLUSIONS This study suggests that inpatient geriatric assessment and management may be an effective approach to the management of pain and psychological status in the elderly cancer inpatient at no greater length of hospitalization or extra cost than usual care",
"BACKGROUND Elderly patients with advanced non-small-cell lung cancer ( NSCLC ) may derive similar benefit from platinum-based chemotherapy as younger patients . Quality of life ( QoL ) and comprehensive geriatric assessment ( CGA ) is often advocated to assess benefits and risks . PATIENTS AND METHODS A total of 181 chemotherapy-naive patients [ ≥70 years , performance score ( PS ) of 0 - 2 ] with stage III-IV NSCLC received carboplatin and gemcitabine ( CG ) ( n = 90 ) or carboplatin and paclitaxel ( CP ) ( n = 91 ) every 3 weeks for up to four cycles . Primary end point was change in global QoL from baseline compared with week 18 . Pretreatment CGA and mini geriatric assessment during and after treatment were undertaken . A principal component ( PC ) analysis was carried out to determine the underlying dimensions of CGA and QoL and subsequently related to survival . RESULTS There were no changes in QoL after treatment . The number of QoL responders ( CG arm , 12 % ; CP arm , 5 % ) was not significantly different . CGA items were only associated with neuropsychiatric toxicity . Quality -adjusted survival was not different between treatment arms . The PC analysis derived from nine CGA , six QoL and one PS score indicated only one dominant dimension . This dimension was strongly prognostic , and physical and role functioning , Groningen Frailty Indicator and Geriatric Depression Scale were its largest contributors . CONCLUSIONS Paclitaxel or gemcitabine added to carboplatin did not have a differential effect on global QoL. CGA was associated with toxic effects in a very limited manner . CGA and QoL items measure one underlying dimension , which is highly prognostic",
"Objective We tested the effect of dietary advice dedicated to increase intake in older patients at risk for malnutrition during chemotherapy , versus usual care , on one-year mortality . Method We conducted a multicentre , open-label interventional , stratified ( centre ) , parallel r and omised controlled trial , with a 1∶1 ratio , with two-year follow-up . Patients were aged 70 years or older treated with chemotherapy for solid tumour and at risk of malnutrition ( MNA , Mini Nutritional Assessment 17–23.5 ) . Intervention consisted of diet counselling with the aim of achieving an energy intake of 30 kCal/kg body weight/d and 1.2 g protein/kg/d , by face-to-face discussion targeting the main nutritional symptoms , compared to usual care . Interviews were performed 6 times during the chemotherapy sessions for 3 to 6 months . The primary endpoint was 1-year mortality and secondary endpoints were 2-year mortality , toxicities and chemotherapy outcomes . Results Between April 2007 and March 2010 we r and omised 341 patients and 336 were analysed : mean ( st and ard deviation ) age of 78.0 y ( 4·9 ) , 51.2 % male , mean MNA 20.2 ( 2.1 ) . Distribution of cancer types was similar in the two groups ; the most frequent were colon ( 22.4 % ) , lymphoma ( 14.9 % ) , lung ( 10.4 % ) , and pancreas ( 17.0 % ) . Both groups increased their dietary intake , but to a larger extent with intervention ( p the energy target was achieved in 57 ( 40.4 % ) patients and the protein target in 66 ( 46.8 % ) with the intervention compared respectively to 13 ( 13.5 % ) and 20 ( 20.8 % ) in the controls . Death occurred during the first year in 143 patients ( 42.56 % ) , without difference according to the intervention ( p = 0.79 ) . No difference in nutritional status changes was found . Response to chemotherapy was also similar between the groups . Conclusion Early dietary counselling was efficient in increasing intake but had no beneficial effect on mortality or secondary outcomes . Cancer cachexia antianabolism may explain this lack of effect . Trial Registration Clinical Trials.gov",
"OBJECTIVES Comprehensive geriatric assessment ( CGA ) is a complex and interdisciplinary approach to evaluate the health status of elderly patients . The Karnofsky Performance Scale ( KPS ) and Physical Performance Test ( PPT ) are less time-consuming tools that measure functional status . This study was design ed to assess and compare abridged geriatric assessment ( GA ) , KPS and PPT as predictive tools of mortality in elderly patients with cancer . MATERIAL S AND METHODS This prospect i ve interventional study included all individuals aged > 70years who were diagnosed with cancer during the study period . Subjects were interviewed directly using a procedure that included a clinical test and a question naire composed of the KPS , PPT and abridged GCA . Overall survival ( OS ) was the primary endpoint . The log rank test was used to compare survival curves , and Cox 's regression model ( forward procedure ) was used for multivariate survival analysis . RESULTS One hundred patients were included in this study . Abridged GA was the only tool found to predict mortality [ median OS for unfit patients ( at least two impairments ) 467days vs 1030days for fit patients ; p=0.04 ] . Patients defined as fit by mean PPT score ( > 20 ) had worse median OS ( 560 vs 721days ) ; however , this difference was not significant ( p=0.488 on log rank ) . Although median OS did not differ significantly between patients with low ( ≤80 ) and high ( > 80 ) KPS scores ( 467 and 795days , respectively ; p=0.09 ) , survival curves diverged after nearly 120days of follow-up . Visual and hearing impairments were the only components of abridged GA of prognostic value . CONCLUSION Neither KPS nor PPT were shown to predict mortality in elderly patients with cancer whereas abridged GA was predictive . This study suggests a possible role for visual and hearing assessment as screening for patients requiring CGA",
"Several instruments have been proposed to improve treatment decisions in elderly cancer patients , but evidence of their impact in clinical practice is limited . The aim of this study was to analyze the role of clinical and functional factors in predicting serious adverse events , including death , severe toxicity or treatment interruption , during chemotherapy in elderly cancer patients . The survey evaluated elderly with lung or colon or breast cancer treated with chemotherapy , followed by S. Giovanni Battista Hospital . We enrolled 110 consecutive patients older than 70 years of age with lung ( n=45 ) , colon ( n=50 ) and breast ( n=15 ) cancer between October 2004 and October 2005 . Overall , 73/110 patients ( 66.4 % ) experienced adverse events as death ( n=14 ) , grade s III and IV toxicity ( n=40 ) , or treatment interruption for other reasons ( n=19 ) . The variables with stronger predictivity were advanced stage , toxicity of treatment , level of comorbidity and Karnofsky performance status ( KPS ) . instrumental activities of daily living ( IADL ) index and age itself were not independent predictors . In conclusion our results confirm the need of a careful selection of elderly patients suitable for chemotherapy , giving more weight to comorbidity and KPS scores than to age itself . The potential role of other functional evaluations need to be further assessed in r and omized controlled trials",
"OBJECTIVES To examine the toxicity experienced by a cohort of older women receiving adjuvant chemotherapy for breast cancer and the longitudinal effect on their functional status and quality of life ( QOL ) . DESIGN A geriatric assessment measuring functional status , comorbidity , mood , nutritional status , and QOL was performed before chemotherapy , at the end of chemotherapy , and 6 months later . SETTING This prospect i ve longitudinal study was conducted at Memorial Sloan-Kettering Cancer Center , New York , New York . PARTICIPANTS Fifty patients aged 65 and older with Stage I to III breast cancer receiving any adjuvant chemotherapy ; 49 were evaluable . MEASUREMENTS The chemotherapy regimen and the toxicity to chemotherapy were recorded . A geriatric assessment was performed before the start of chemotherapy , on completion of chemotherapy , and 6 months after completion of chemotherapy . QOL testing was performed at the same times . RESULTS Patients ( mean age 68 , range 65 - 84 ) received an anthracycline-based chemotherapy regimen ( n=15 ) or cyclophosphamide 600 mg/m2 intravenously ( i.v . ) , methotrexate 40 mg/m2 i.v . , 5-fluorouracil 600 mg/m2 i.v . every 3 weeks for eight cycles ( n=34 ) . Grade 3 or 4 toxicity occurred in 53 % ( n=26 ) , hematological toxicity in 27 % ( n=13 ) , and nonhematological toxicity in 31 % ( n=15 ) . Despite toxicity , there was no significant longitudinal change in functional status or QOL . CONCLUSION Despite toxicity from adjuvant chemotherapy , this cohort of relatively young older patients maintained their functional status and QOL from before chemotherapy to 6 months postchemotherapy . Subtle changes in higher-order functioning would require assessment using different geriatric assessment tools",
"Abstract Multidimensional geriatric assessment ( GA ) has been demonstrated to predict outcomes in older patients with cancer . This study evaluated GA in a cohort of older patients with chronic lymphocytic leukemia ( CLL ) . Seventy-five of 97 subjects with CLL who were enrolled in a clinical trial of the German CLL Study Group underwent GA prior to the start of study treatment ( low-dose chemotherapy with fludarabine ) . GA included cumulative illness rating scale ( CIRS ) , timed-up- and -go ( TUG ) test , dementia detection ( DEMTECT ) test and instrumental activities of daily living ( IADL ) index . There was little correlation between CIRS , TUG , DEMTECT or IADL results and treatment toxicity , feasibility or efficacy in this study . CIRS and IADL had no statistically significant impact on overall prognosis . However , under-performance in TUG or DEMTECT test was strongly associated with poor survival . The latter findings provide a rationale to further investigate geriatric assessment in CLL and in the context with other CLL treatments",
"OBJECTIVES The purpose of this prospect i ve observational study is to evaluate the relation of the comprehensive geriatric assessment ( CGA ) to tolerability and survival of multi-agent chemotherapy for curative intent in elderly patients with aggressive non-Hodgkin lymphoma ( NHL ) . MATERIAL S AND METHODS Patients who were 1 ) age ≥65 years , 2 ) newly diagnosed aggressive NHL , and 3 ) treated with multi-agent chemotherapy within 2 weeks from the time of diagnosis were enrolled from January 2011 to June 2014 . Baseline clinical , laboratory , and CGA data being composed of Mini Nutritional Assessment -Short Form ( MNA-SF ) , Korean version of Mini Mental Status Exam , Korean-Geriatric Depression Scale , and Groningen Frailty Index ( GFI ) , were collected and analyzed for the relation to the outcome factors . RESULTS Seventy patients were included ; the median age was 73.5 years , 27 ( 38.6 % ) patients were Eastern Cooperative Oncology Group ( ECOG ) performance status ( PS ) of 2 or more , and half of the patients were high or high-intermediate risk by age-adjusted international prognostic index ( aaIPI ) . Most patients received CHOP or CHOP-like chemotherapy . Factors affecting discontinuation of chemotherapy within 12 weeks were poor MNA-SF , poor GFI , poor PS , and presence of B symptom . Among those , poor MNA-SF was independent of other variables in multivariate analysis . Poor MNA-SF , bone marrow involvement , and baseline anemia of hemoglobin g /dL were found to be independent factors associated with inferior overall survival whereas aaIPI factors were not . CONCLUSION MNA-SF predicted tolerability to multi-agents chemotherapy and overall survival in elderly patients with aggressive NHL who were treated with multi-agent chemotherapy ",
"OBJECTIVES To evaluate the effect of nurse case management on the treatment of older women with breast cancer . DESIGN R and omized prospect i ve trial . SETTING Sixty surgeons practicing at 13 community and two public hospitals in southeast Texas . PARTICIPANTS Three hundred thirty-five women ( 166 control and 169 intervention ) aged 65 and older newly diagnosed with breast cancer . INTERVENTION Women seeing surgeons r and omized to the intervention group received the services of a nurse case manager for 12 months after the diagnosis of breast cancer . MEASUREMENTS The primary outcome was the type and use of cancer-specific therapies received in the first 6 months after diagnosis . Secondary outcomes were patient satisfaction and arm function on the affected side 2 months after diagnosis . RESULTS More women in the intervention group received breast-conserving surgery ( 28.6 % vs 18.7 % ; P=.031 ) and radiation therapy ( 36.0 % vs 19.0 % ; P=.003 ) . Of women undergoing breast-conserving surgery , greater percentages in the case management group received adjuvant radiation ( 78.3 % vs 44.8 % ; P=.001 ) and axillary dissection ( 71.4 % vs 44.8 % ; P=.057 ) . Women in the case management group were also more likely to receive more breast reconstruction surgery ( 9.3 % vs 2.6 % , P=.054 ) , and women in the case management group with advanced cancer were more likely to receive chemotherapy ( 72.7 % vs 30.0 % , P=.057 ) . Two months after surgery , higher percentages of women in the case manager group had normal arm function ( 93 % vs 84 % ; P=.037 ) and were more likely to state that they had a real choice in their treatment ( 82.2 % vs 69.9 % , P=.020 ) . Women with indicators of poor social support were more likely to benefit from nurse case management . CONCLUSION Nurse case management results in more appropriate management of older women with breast cancer",
"CONTEXT Changes in the healthcare system have result ed in shortened hospital stays , moving the focus of care from the hospital to the home . Patients are discharged post-operatively with ongoing needs , and whether they receive nursing care post-hospitalization can influence their recovery and survival . Little information is available about the factors that influence outcomes , including the survival of older cancer patients after cancer surgery . OBJECTIVE To compare the length of survival of older post-surgical cancer patients who received a specialized home care intervention provided by advanced practice nurses ( APNs ) with that of patients who received usual follow-up care in an ambulatory setting . We also assessed potential predictors of survival in terms of depressive symptoms , symptom distress , functional status , comorbidities , length of hospital stay , age of patient , and stage of disease . DESIGN A r and omized controlled intervention study . SETTING Discharged older cancer patients after surgery at a Comprehensive Cancer Center in southeastern Pennsylvania . PATIENTS Three hundred seventy-five patients aged 60 to 92 , newly diagnosed with solid cancers , were treated surgically between February 1993 and December 1995 . One hundred ninety patients were r and omized to the intervention groups and 185 to the usual care group . INTERVENTION The intervention was a st and ardized protocol that consisted of st and ard assessment and management post-surgical guidelines , doses of instructional content , and schedules of contacts . The intervention lasted 4 weeks and consisted of three home visits and five telephone contacts provided by APNs . Both the patients and their family caregivers received comprehensive clinical assessment s , monitoring , and teaching , including skills training . MAIN OUTCOME MEASURE Time from enrollment of patients into the study until death or last date known alive at the end of November 1996 . RESULTS During the 44-month follow-up period , 93 ( 24.8 % ) of 375 patients died . Forty-one ( 22 % ) of those who died were patients in the specialized home care intervention group , compared with 52 ( 28 % ) in the usual care group . Stage of disease at diagnosis differed between the two groups at baseline ( 38 % late stage patients in the intervention group compared with 26 % in the control group , P = .01 ) , so stratified analysis was performed . Overall , the specialized home care intervention group was found to have increased survival ( P = .002 using stratified log-rank test ) . Among early stage patients only , there was no difference in survival between the intervention and control groups . Among late stage patients , there was improved survival in the intervention group . For example , 2-year survival among late stage intervention group cases was 67 % compared with 40 % among control cases . When Cox 's proportional hazard model was used to adjust for significant baseline covariates , the relative hazard of death in the usual care group was 2.04 ( CI : 1.33 to 3.12 ; P = .001 ) after adjusting for stage of disease and surgical hospitalization length of stay . CONCLUSIONS This is the first empirical study of post-surgical cancer patients to link a specialized home care intervention by advanced practice nurses with improved survival . Additional research is needed to test home care interventions aim ed at maintaining quality of life outcomes and their effects on survival of post-surgical cancer patients",
"BACKGROUND A number of elderly cancer patients do not receive st and ard surgery for solid tumors because they are considered unfit for treatment as a consequence of inaccurate estimation of the operative risk . To tailor treatment to onco-geriatric series , oncologists are now beginning to use a comprehensive geriatric assessment ( CGA ) . This study investigates the value of an extended CGA in assessing the suitability of elderly patients for surgical intervention . PATIENTS AND METHODS Preoperative assessment of cancer in the elderly ( PACE ) incorporates vali date d instruments including the CGA , an assessment of fatigue and performance status and an anaesthesiologist 's evaluation of operative risk . An international prospect i ve study was conducted using 460 consecutively recruited elderly cancer patients who received PACE prior to elective surgery . Mortality , post-operative complications ( morbidity ) and length of hospital stay were recorded up to 30 days after surgery . RESULTS Poor health in relation to disability ( assessed using the instrumental activities of daily living ( IADL ) ) , fatigue and performance status ( PS ) were associated with a 50 % increase in the relative risk of post-operative complications . Multivariate analysis identified moderate/severe fatigue , a dependent IADL and an abnormal PS as the most important independent predictors of post-surgical complications . Disability assessed by activities of daily living ( ADL ) , IADL and PS were associated with an extended hospital stay . CONCLUSION PACE represents a valuable tool in enhancing the decision process concerning the c and idacy of elderly cancer patients for surgical intervention and can reduce inappropriate age-related inequity in access to surgical intervention . It is recommended that PACE be used routinely in surgical practice",
"BACKGROUND Nutritional status ( NS ) , though frequently affected in onco-geriatric patients , is no st and ard part of a geriatric assessment . The aim of this study was to analyse the association between a preoperatively impaired NS and geriatric domain impairments and adverse postoperative outcomes in onco-geriatric surgical patients . METHODS 309 patients ≥70 years undergoing surgery for solid tumours were prospect ively recruited . Nine screening tools were preoperatively administered as part of a geriatric assessment . NS was based on BMI , weight loss and food intake . Odds ratio 's ( OR ) and 95 % confidence intervals ( 95 % CI ) were estimated using logistic regression analysis . The occurrence of 30-day adverse postoperative outcomes was recorded . RESULTS At a median age of 76 years , 107 patients ( 34.6 % ) had an impaired NS . Decreased performance status and depression were associated with an impaired NS , when adjusted for tumour characteristics and comorbidities ( ORPS>1 3.46 ; 95 % CI 1.56 - 7.67 . ORGDS>5 2.11 ; 95 % CI 1.05 - 4.26 ) . An impaired NS was an independent predictor for major complications ( OR 3.3 ; 95 % CI 1.6 - 6.8 ) . Ten out of 11 patients who deceased had an impaired NS . CONCLUSION An impaired NS is prevalent in onco-geriatric patients considered to be fit for surgery . It is associated with decreased performance status and depression . An impaired NS is a predictor for adverse postoperative outcomes . NS should be incorporated in a geriatric assessment",
"Objectives : The comprehensive geriatric assessment ( CGA ) can detect geriatric problems and potentially improve survival , physical , and cognitive state of patients , as well as increase an older person ’s chances of staying at home longer . In older people , the number and severity of comorbidity increase with age and are an important determinant of survival . The aim of the study was to assess to which extent CGA and comorbidities could be seen as determinants of survival . Material s and methods : This study analyzed data from two hospitals that included geriatric assessment s of patients aged 70 years and more with cancer linked to mortality . Logistic regression was used to model survival predictors . Results : Two hundred and five various cancer patients ( 47 % females ) with a median age of 79 were included . They presented with a lot of undiagnosed geriatric problems . Screening scales ( G8 , SEGA ) , cognitive , and psychological disorders , and low albumin levels appeared to be independent survival factors . A frailty profile classification was associated with higher mortality . The average comorbidity was grade d 2 according to the Charlson scale . By the geriatric cumulative illness rating scale ( CIRS-G ) , the arithmetic average number of affected organ systems was 5 ( range 0–10 ) in all patients . Cardiovascular disorders were the most common comorbidity . Renal insufficiency and anaemia were negatively associated with survival . Conclusion : Old cancer patients present a lot of comorbidities and newly diagnosed geriatric problems . Several tools provide determinants of survival in old cancer patients . Prospect i ve trials evaluating the utility of a CGA to guide interventions to improve quality of cancer care in older adults are justified",
"AIMS Comprehensive Geriatric Assessment ( CGA ) provides information on aspects of older patients to predict risks and benefits of interventions . METHODS To evaluate the application of CGA ( including quality of life ( QOL ) ) for the risk prediction of postoperative dependence and QOL in elderly patients with malignant tumours , a prospect i ve observational study including 200 patients > 70 years was performed . The primary outcome was postoperative activities of daily living ( ADL , secondary outcome was QOL at 6 months . Multivariate regression was performed to assess the impact of associated factors ( socio-demographic , clinical , functional , cognitive variables , resilience , and EORTC-QLQ-C30 QOL ) . RESULTS Median age of patients was 75 ( 70 - 88 ) years with 69 % males . The majority of operations was for colon carcinoma ; morbidity was 24.8 % , mortality 1.5 % . Impairment in ADL ( loss of ADL , the following reached significance : BMI ( OR : 1.7 ; p = 0.019 ) , ADL ( OR : 0.67 ; p = 0.0317 ) , and of the QLQ-C30 : diarrhea ( OR : 1.04 ; p = 0.013 ) , emotional functioning ( OR : 0.91 ; p = 0.0242 ) , physical functioning ( OR : 0.92 ; p = 0.027 ) . QOL paralleled ADL ( pre-op : 65.4 to 67 postoperatively , respectively ) ; predictive were : Karnofsky Index ( Parameter Estimate ( PE ) : 0.55 ; p = 0.0003 ) and ( QLQ-C30 ) emotional functioning ( PE : 0.14 ; p = 0.0208 ) . CONCLUSIONS Those considered for oncologic surgery can be assured that few lose independence . CGA/QOL highlight signs of vulnerability and options for pre-habilitation . Registries including a minimal CGA data set will make pre- selection s reproducible and objectify risk/benefit estimations - relevant for those withheld from potentially curative surgery",
"Abstract The age-adjusted International Prognostic Index ( IPI ) is an important prognostic factor for patients with non-Hodgkin lymphoma ( NHL ) . We investigated whether a geriatric assessment ( GA ) is of additional prognostic value in NHL . In this prospect i ve cohort study of 44 patients aged 70 years or older with NHL receiving rituximab , cyclophosphamide , doxorubicin , vincristine and prednisone ( R-CHOP ) , a GA was administered before the start of chemotherapy . GA was composed of the Mini Nutritional Assessment ( MNA ) , Groningen Frailty Indicator ( GFI ) , Informant Question naire on Cognitive Decline in the Elderly ( IQCODE ) , Mini Mental State Examination ( MMSE ) and levels of albumin , creatinine , lactate dehydrogenase ( LDH ) and hemoglobin . Multivariate analyses were performed using logistic regression and the Cox regression model . After adjustment for sex , age , comorbidity and univariate laboratory values with p ≤ 0.1 , abnormal MNA and GFI scores and low hemoglobin level were associated with not being able to complete the intended chemotherapy : odds ratio ( OR ) 8.29 ( 95 % confidence interval [ CI ] : 1.24–55.6 ; p = 0.03 ) , 9.17 ( 95 % CI : 1.51–55.8 ; p = 0.02 ) and 5.41 ( 95 % CI : 0.99–29.8 ; p = 0.05 ) , respectively . Adjusted for sex , age , comorbidity , age-adjusted IPI and univariate laboratory values with p ≤ 0.1 , frailty by GFI and low hemoglobin were associated with worse survival , with a hazard ratio ( HR ) of mortality of 2.55 ( 95 % CI : 1.07–6.10 ; p = 0.04 ) and 4.90 ( 95 % CI : 1.76–13.7 ; p = 0.002 ) , respectively . We conclude that ( risk of ) malnutrition , measured with the MNA , frailty , measured with the GFI , and low hemoglobin level had additional predictive value for early treatment withdrawal , and GFI and hemoglobin were , independent of the age-adjusted IPI , predictive for an increased mortality risk",
"PURPOSE Older adults are vulnerable to chemotherapy toxicity ; however , there are limited data to identify those at risk . The goals of this study are to identify risk factors for chemotherapy toxicity in older adults and develop a risk stratification schema for chemotherapy toxicity . PATIENTS AND METHODS Patients age ≥ 65 years with cancer from seven institutions completed a prechemotherapy assessment that captured sociodemographics , tumor/treatment variables , laboratory test results , and geriatric assessment variables ( function , comorbidity , cognition , psychological state , social activity/support , and nutritional status ) . Patients were followed through the chemotherapy course to capture grade 3 ( severe ) , grade 4 ( life-threatening or disabling ) , and grade 5 ( death ) as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events . RESULTS In total , 500 patients with a mean age of 73 years ( range , 65 to 91 years ) with stage I to IV lung ( 29 % ) , GI ( 27 % ) , gynecologic ( 17 % ) , breast ( 11 % ) , genitourinary ( 10 % ) , or other ( 6 % ) cancer joined this prospect i ve study . Grade 3 to 5 toxicity occurred in 53 % of the patients ( 39 % grade 3 , 12 % grade 4 , 2 % grade 5 ) . A predictive model for grade 3 to 5 toxicity was developed that consisted of geriatric assessment variables , laboratory test values , and patient , tumor , and treatment characteristics . A scoring system in which the median risk score was 7 ( range , 0 to 19 ) and risk stratification schema ( risk score : percent incidence of grade 3 to 5 toxicity ) identified older adults at low ( 0 to 5 points ; 30 % ) , intermediate ( 6 to 9 points ; 52 % ) , or high risk ( 10 to 19 points ; 83 % ) of chemotherapy toxicity ( P the risk of chemotherapy toxicity in older adults . Geriatric assessment variables independently predicted the risk of toxicity ",
"OBJECTIVE The geriatric assessment ( GA ) has proven to be of great value for clinicians treating older patients . However , a clear consensus on the optimal set of GA instruments is lacking , particularly for surgical patients . Therefore , the aim of this prospect i ve study was to compare the prevalence of frailty , depending on the number of incorporated GA domains , and to evaluate its accuracy in predicting postoperative outcome . MATERIAL S AND METHODS Seventy-five patients aged 65 years and older , qualified for abdominal surgery due to solid cancer , were enrolled . The GA included a wide variety of vali date d tools that evaluate functional , mobility , nutritional , co-morbidity , polypharmacy , and psychosocial domains . RESULTS Depending on the number of incorporated GA domains the frequency of frailty was 23 - 97 % . The cumulative score rather than individual components of the GA , turned out to be an independent risk factor of 30-day postoperative morbidity . In predicting 30-day \" any \" and \" major \" morbidities , the area under the curve was 0.67 - 0.72 and 0.70 - 0.82 ( model including the severity of the surgery ) vs. 0.57 - 0.66 and 0.50 - 0.65 ( model not including the severity of the surgery ) , respectively . CONCLUSION The number of incorporated GA domains has a great influence on the prevalence of frailty and on adequate surgical risk assessment . The summary deficit score based on Pre-operative Assessment of Cancer in the Elderly ( PACE ) or the GA consisting of functional , mobility , cognitive , depression , nutritional , co-morbidity , polypharmacy , and social support assessment domains can predict 30-day postoperative morbidity . However , only models with addition of the severity of surgery show moderate to good predictive value",
"Abstract In 2003 the Fondazione Italiana Linfomi ( FIL ) started a clinical research program for investigating initial treatment of frail elderly patients with diffuse large B-cell lymphoma ( DLBCL ) identified by Comprehensive Geriatric Assessment ( CGA ) . From 2003 to 2006 , 334 elderly patients underwent CGA assessment , and 99 patients were classified as frail . Frail patients had a median age of 78 years , stage III – IV disease in 62 % and age-adjusted International Prognostic Index ( aaIPI ) of 2–3 in 53 % . Treatment consisted of several different regimens according to physician discretion . After a median follow-up of 36 months , 5-year overall survival ( OS ) was 28 % . In multivariate analysis , aaIPI 2–3 ( p = 0.005 ) and the presence of respiratory comorbidity ( p = 0.044 ) were the only factors that showed independent correlation with OS . Frail patients had a poorer outcome compared with fit patients also if they were treated with rituximab-containing combination chemotherapy ( hazard ratio 2.37 , 95 % confidence interval 1.48–3.78 ; p < 0.001 ) . CGA is a valid tool to prospect ively identify frail subjects among elderly patients with DLBCL",
"Aims : The study aims to determine whether the Comprehensive Geriatric Assessment ( CGA ) could predict complications of colorectal cancer ( CRC ) surgery and identify the problems . So we compared the prognostic value of the CGA with patient characteristics and determined predictive scores . Methods : A total of 156 patients aged 75 years and older , who underwent surgery for CRC at Osaka University Hospital , were enrolled . Each patient was examined by the CGA prospect ively , and all postoperative complications were obtained from the medical records . The CGA included the Barthel Index ( BI ) , Vitality Index , instrumental activities of daily living ( iADL ) , Mini-Mental State Examination ( MMSE ) and Geriatric Depression Score ( GDS ) . All elements were retrospectively compared in patients with or without postoperative complications , including delirium , surgical site infection and ileus . Results : Overall , postoperative complications developed in 76 patients ( 48.7 % ) . The BI and MMSE were associated with the incidence of complications , and BI , iADL , MMSE and GDS were significantly related with delirium . Multivariate logistic analysis identified the MMSE as a significant determinant of postoperative complications after adjusting for other determined predictive scores including the prognostic nutritional index and performance status . Conclusion : The CGA was a useful predictor of postoperative complications in elderly patients when administered before surgery for CRC",
"BACKGROUND The purpose of this prospect i ve study was to identify risk factors for adverse outcomes or increased re source utilization after abdominal cancer surgery in geriatric patients . METHODS Baseline clinical and geriatric assessment variables including functional status , nutritional status , comorbidity index , mental status , depression scale score , fatigue inventory scale , and polypharmacy scale were prospect ively recorded for patients age ≥65 undergoing intra-abdominal oncologic surgery . Outcome variables included morbidity , mortality , discharge to nursing facility , prolonged hospital stay , and readmission . RESULTS Of 111 patients , surgery type was colorectal in 40 % , hepatopancreatobiliary in 30 % , and gastric/duodenal in 14 % . Variables associated with discharge to a nursing facility on multivariate analysis included weight loss ≥10 % ( OR 6.52 [ 95 % CI : 1.43 - 29.76 ] , P = 0.02 ) , ASA score ≥2 ( OR 5.08 [ 1.13 - 22.77 ] , P = 0.03 ) , and ECOG score ≥2 ( OR 4.51 [ 1.03 - 19.71 ] , P = 0.04 ) . Variables independently associated with prolonged hospital stay included weight loss ≥10 % ( OR 4.03 [ 1.13 - 14.43 ] , P = 0.03 ) , the presence of polypharmacy ( OR 2.45 [ 1.09 - 5.48 ] , P = 0.03 ) , and distant disease ( OR 0.37 [ 0.15 - 0.91 ] , P = 0.03 ) . No variables were associated with morbidity or readmission . CONCLUSIONS Pre-operative clinical and geriatric assessment tools can help predict the need for discharge to a nursing facility or increased length of stay . Future studies will be required to identify patients suitable for interventions to decrease hospital and post-discharge re source utilization ",
"BACKGROUND Colorectal cancer ( CRC ) is prevalent in the older population . Geriatric assessment ( GA ) has previously been found to predict treatment tolerance and postoperative complications in older cancer patients . The aim of this study was to explore whether GA also predicts 1-year and 5-year survival after CRC surgery in older patients and to compare the predictive power of GA with that of established prognostic factors such as TNM classification of malignant tumors ( TNM ) stage and age . MATERIAL S AND METHODS A cohort of 178 CRC patients aged 70 and older were followed prospect ively . All patients went through elective surgery , and GA was performed presurgery . The GA result ed in patients being divided into two groups : frail or nonfrail . All patients were followed for 5 years or until death . Data were analyzed by Kaplan-Meier plots and the Cox proportional hazards model . RESULTS Seventy-six patients ( 43 % ) were frail , and one hundred and two ( 57 % ) were nonfrail . Twenty-three patients ( 13 % ) died during the first year after surgery . One-year survival was 80 % in the frail group and 92 % in the nonfrail group . Five-year survival was significantly lower in frail ( 24 % ) than nonfrail patients ( 66 % ) , and this difference was apparent both within the stratums of TNM stages 0-II and TNM stage III . In multivariable analysis adjusting for TNM stage , age , and sex , frailty was an independent prognostic factor for survival . CONCLUSION A GA-based frailty assessment predicts 1-year and 5-year survival in older patients after surgery for CRC . In localized and regional disease , the impact of frailty upon 5-year survival is comparable with that of TNM stage",
"BACKGROUND Data from prospect i ve clinical trials are needed to better define st and ards of care in elderly patients with advanced ovarian carcinoma and to demonstrate the interest of Comprehensive Geriatric Assessment ( CGA ) in this fragile and heterogeneous population . PATIENTS AND METHODS From July 1998 to October 2000 , 83 advanced ovarian carcinoma patients > 70 years old received carboplatin AUC 5 and cyclophosphamide 600 mg/m2 , on day 1 of six 28-day cycles . The clinical and biological geriatric covariates prospect ively studied were : comorbidities , comedications , cognitive functions ( Mini-Mental test ) , nutritional status and autonomy . RESULTS Patient characteristics were : median age 76 years , serous histology ( 73 % ) , FIGO stage III ( 75 % ) , optimal initial surgery ( 21 % ) and performance status ( PS ) > or = 2 ( 44 % ) . Sixty patients ( 72 % ) received six chemotherapy cycles without severe toxicity ( STox ) or tumor progression . Multivariate analysis retained three factors as independent predictors of STox : symptoms of depression at baseline ( P = 0.006 ) , dependence ( P = 0.048 ) and PS > or = 2 ( P = 0.026 ) . Independent prognostic factors identified for overall survival ( Cox model ) were depression ( P = 0.003 ) , FIGO stage IV ( P = 0.007 ) and more than six different comedications per day ( P = 0.043 ) . CONCLUSION CGA could predict STox and overall survival of elderly advanced ovarian carcinoma patients",
"PURPOSE To determine factors associated with early functional decline during first-line chemotherapy in older patients . PATIENTS AND METHODS Patients age ≥ 70 years receiving first-line chemotherapy for cancer were prospect ively considered for inclusion across 12 centers in France . Functional decline was defined as a decrease of ≥ 0.5 points on the Activities of Daily Living ( ADL ) scale between the beginning of chemotherapy and the second cycle . Factors associated with functional decline were sought from pretreatment abbreviated comprehensive geriatric assessment , including ADL , Instrumental ADL ( IADL ) , Mini-Nutritional Assessment ( MNA ) , Mini-Mental State Examination ( MMSE ) , Geriatric Depression Scale ( GDS15 ) , and Timed Get Up and Go ( GUG ) test , and from comorbidities ( Cumulative Illness Rating Scale-Geriatrics ) , MAX2 index , and baseline biologic and clinical information . RESULTS Of 364 included patients , 50 experienced functional decline ( 16.7 % ; median , 0.5 points ) . Abnormal preadmission performance status , IADL , GDS15 , MMSE , GUG , and MNA were associated with increased likelihood of functional decline ( univariate analysis ) . In the multivariate model adjusted for baseline ADL and MAX2 index , high baseline GDS ( odds ratio [ OR ] , 2.16 ; 95 % CI , 1.09 to 4.30 ; P = .03 ) and low IADL scores ( OR , 2.87 ; 95 % CI , 1.06 to 7.79 ; P = .04 ) were independently associated with increased risk of functional decline . CONCLUSION Our results outline associations between baseline depression , instrumental dependencies , and early functional decline during chemotherapy for older patients . ADL should be sequentially evaluated early during treatment . Baseline evaluation of GDS15 and IADL may be proposed to anticipate this event",
"BACKGROUND Mortality prediction is crucial to select the optimal treatment in elderly cancer patients . Our objective was to identify cancer-related factors and Comprehensive Geriatric Assessment ( CGA ) findings associated with 1-year mortality in elderly in patients and out patients with cancer . METHODS We prospect ively included patients aged ≥70 years who had solid or hematologic malignancies and in whom the CGA was performed by geriatricians in two French teaching hospitals . We identified independent predictors of 1-year mortality after study inclusion , using multivariate Cox models stratified on inpatient/outpatient status . We built three multivariate Cox models , since strong correlations linked activities of daily living ( ADL ) , Eastern Cooperative Oncology Group Performance Status ( ECOG-PS ) , and timed get-up- and -go test ( GUG ) results ; and since physicians ' preferences for these three assessment s vary . A sensitivity analysis was performed using multiple imputation . RESULTS Of the 993 patients ( mean age , 80.2 years ; 51.2 % men ) , 58.2 % were out patients and 46 % had metastatic disease . Colorectal cancer was the most common malignancy ( 21.4 % ) . Mortality rates after 6 and 12 months were 30.1 % and 41.2 % , respectively . In all models , tumor site and metastatic status ( p 80 years ( p higher number of severe comorbidities ( p and malnutrition ( p with death independently from impaired ECOG-PS ( p and GUG ( p ) . The adverse effect of metastatic status differed significantly across tumor sites , being greatest for breast and prostate cancer ( p of 1-year mortality identified in our study may help physicians select the optimal cancer-treatment strategy in elderly patients",
"INTRODUCTION In general , geriatric assessment ( GA ) provides the combined information on comorbidity and functional , nutritional and psychosocial status and may be predictive for mortality outcome of cancer patients . The impact of geriatric assessment on the outcome of older patients with colorectal cancer treated with chemotherapy is largely unknown . METHODS In a prospect i ve study , 143 patients with colorectal cancer who were 70years and older were assessed before chemotherapy by Mini Nutritional Assessment ( MNA ) , Informant Question naire on Cognitive Decline in the Elderly ( IQCODE ) , Groningen Frailty Indicator ( GFI ) and Mini Mental State Examination ( MMSE ) . RESULTS Fifty-four ( 38 % ) patients received adjuvant chemotherapy and 89 ( 62 % ) patients received palliative chemotherapy . Malnutrition and frailty were prevalent in 39 ( 27 % , assessed by MNA ) and 34 ( 24 % , by GFI ) patients , respectively ; whereas cognitive impairment was prevalent in 19 ( 13 % , by IQCODE ) and 11 ( 8 % , by MMSE ) patients , respectively . In patients with palliative chemotherapy , poor MNA scores were associated with receiving less than 4cycles of chemotherapy ( p=0.008 ) . Poor MNA and GFI scores were associated with increased hazard ratios ( HR ) for mortality for patients with palliative chemotherapy : HR=2.76 ( 95 % confidence interval [ CI ] : 1.60 - 4.77 ; p Malnutrition and frailty were strongly associated with an increased mortality risk in patients who underwent palliative chemotherapy . Furthermore , a poor score on MNA was predictive for less tolerance of chemotherapy . Our findings may help the oncologist in future decision making and advice for elderly patients with colorectal cancer",
"OBJECTIVES Our purpose was to determine whether geriatric assessment s are associated with completion of a chemotherapy course , grade III/IV toxicity or survival in older adults with cancer . MATERIAL S AND METHODS In this prospect i ve cohort study , patients aged 65 years and older with colorectal , lung , or breast cancer or lymphoma completed a brief geriatric assessment prior to chemotherapy . Endpoints included completion of the planned number of chemotherapy cycles , grade III/IV toxicity and survival . Multivariate logistic regression determined which factors were independently associated with completion of therapy , grade III/IV toxicity or death . RESULTS Sixty-five patients were enrolled in the study . The median age was 73 years ( range 65–89 ) . Geriatric syndromes were common , including depression ( 21.5 % ) , dependence on others to carry out instrumental activities of daily living ( 38.5 % ) and activities of daily living ( 10.8 % ) , and comorbidities ( mild 47.7 % , moderate 20 % , severe 15.4 % ) . Of the 65 participants , 67.6%completed the planned number of chemotherapy cycles . Curative intent therapy [ OR 4.97 ( 95 % CI 1.21–18.81 ) ] , Eastern Cooperative Oncology Group ( ECOG ) performance status 2–3 [ OR 0.089 ( 0.015–0.53 ) ] and renal function [ OR 1.03 ( 1.00–1.06 ) per ml/min ] were significantly associated with therapy completion . Furthermore , 31.1 % experienced grade III/IV nonhematologic toxicity . Moderate to severe comorbidities significantly increased the risk of grade III/IV non-hematologic toxicity [ OR 6.13 ( 1.65–22.74 ) ] . Patients who received chemotherapy with curative intent had lower mortality [ HR 0.15 ( 0.06–0.42 ) ] , while patients who reported a fall in themonth prior to chemotherapy had an increased risk of death [ HR 3.20 ( 1.13–9.11 ) ] . CONCLUSIONS Geriatric assessment is associatedwith completion of a planned number of cycles of chemotherapy , grade III/IV non-hematologic toxicity , and mortality "
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Purpose All surgical procedures elicit a complex systemic inflammatory response effectuated and modulated by cytokines . The purpose of this systematic review was to present an overview of the inflammatory response and the serum markers associated with hernia repair and to compare the response between patients treated with and without mesh . Methods The review was conducted in line with PRISMA guidelines . The outcomes of interest were serum concentration of leukocytes , cytokines , and acute phase proteins before and after hernia repair with or without mesh reinforcement . The risk of bias was assessed using the Cochrane ROBINS-I tool for non-r and omized studies of intervention . Results A total of 31 studies were included in the systematic review including 1326 patients with a mean age ranging from 33 to 67 years . The studies predominantly included males ( 95.0 % males , 5.0 % female ) with inguinal hernias ( 98.5 % inguinal hernias , 1.5 % incisional hernias ) . The inflammatory response after hernia repair was characterized by an increase in CRP , IL-6 , leukocytes , neutrophils , IL-1 , IL-10 , fibrinogen , and α1-antitrypsin and a decrease in lymphocytes and albumin within the first 24 postoperative hours . The systemic inflammatory response was normalized before or on the seventh postoperative day . A higher CRP and IL-6 serum concentration was found in patients treated with mesh compared with sutured repairs . Conclusions Hernia repair elicits a systemic inflammatory response characterized by an increase in CRP , IL-6 , leukocytes , neutrophils , IL-1 , IL-10 , fibrinogen , and α1-antitrypsin and a decrease in lymphocytes and albumin . A higher inflammatory response was found after mesh repair compared with non-mesh repair and after open mesh repair compared with laparoscopic mesh repair | [
"Endoscopic techniques are commonly used for many different types of surgery . It is cl aim ed that videoendoscopic procedures have the advantage of being less traumatic and of offering higher postoperative patient comfort than conventional open techniques . The extent of tissue trauma can be evaluated on the basis of the inflammatory response observed in the wake of surgery . Available studies that have compared endoscopic and conventional techniques suggest that endoscopic cholecystectomy , laparoscopic colorectal resection , and thoracoscopic pulmonary resection have immunologic advantages over conventional approaches . The objective of this prospect i ve study was to determine whether endoscopic hernia repair techniques are also preferable to conventional procedures and to what extent the anesthetic technique ( local or general anesthesia ) influences the postoperative inflammatory response . For this purpose , biochemical monitoring of cytokine activity [ C-reactive protein ( CRP ) , prostagl and in F1α ( PGF1α ) , neopterin , interleukin-6 ( IL-6 ) ] was done prospect ively in 101 patients [ totally extraperitoneal approach ( TEP ) n=32 , unilateral n=12 , bilateral n=20 ; Shouldice n=69 , local anesthesia ( LA ) n=23 , general anesthesia ( GA ) n=46 ] before and until 3 days after surgery . The parameters IL-6 and PGF1α suggested that the immune trauma immediately after surgery was significantly higher in the group of patients with endoscopic hernia repair than in the group of patients who received a Shouldice repair . No significant differences were observed after the first postoperative day . A comparison between the TEP group and the patients who received conventional surgery under local anesthesia showed that the TEP approach was also associated with a higher postoperative neopterin level . Within the first 3 days after surgical intervention , bilateral endoscopic hernia repair induced no significantly higher inflammatory response than the surgical treatment of unilateral conditions . The anesthetic procedure that was used in the Shouldice operation had no significant effect on inflammatory response . Unlike other types of endoscopic surgery , the repair of groin hernias using an endoscopic technique can not be regarded as a minimally invasive procedure that is less traumatic than conventional approaches . Instead , the conventional Shouldice procedure appears to cause the lowest inflammatory response and to be the least traumatic approach to hernia repair , especially when it is performed under local anesthesia",
"BACKGROUND The purpose of this study was to evaluate the involvement of inflammatory mediators in patients undergoing Lichtenstein tension-free hernioplasty ( LH ) using polypropylene prosthetic material s or conventional Bassini hernia repair ( BH ) . METHODS Thirty patients male with unilateral inguinal hernia without complications or recurrence were included in this study . R and omly , patients underwent LH or BH . Peripheral venous bloods sample s were collected 24 hours prior to surgery and then 6 , 24 , 48 and 168 hours postoperatively . RESULTS We present evidence s that LH patients showed a higher increased serum level of fibrinogen , C-reactive protein , alpha-1-antitrypsin , and interleukin-6 than BH patients . Postoperative visual analogue scales for pain were reduced on mobilization for patients undergoing LH compared with BH . Neutrophils were significantly increased only in LH compared with baseline . Ceruloplasmin , transferrin , and albumin levels were unmodified after BH or LH . CONCLUSIONS In conclusion our data show that although LH induces less pain and more rapid postoperative recovery , it is associated with an higher inflammatory response compared with BH , likely due to polypropylene mesh",
"Objective : The objective of this study was to determine the best treatment of incisional hernia , taking into account recurrence , complications , discomfort , cosmetic result , and patient satisfaction . Background : Long-term results of incisional hernia repair are lacking . Retrospective studies and the midterm results of this study indicate that mesh repair is superior to suture repair . However , many surgeons are still performing suture repair . Methods : Between 1992 and 1998 , a multicenter trial was performed , in which 181 eligible patients with a primary or first-time recurrent midline incisional hernia were r and omly assigned to suture or mesh repair . In 2003 , follow-up was up date d. Results : Median follow-up was 75 months for suture repair and 81 months for mesh repair patients . The 10-year cumulative rate of recurrence was 63 % for suture repair and 32 % for mesh repair ( P Abdominal aneurysm ( P = 0.01 ) and wound infection ( P = 0.02 ) were identified as independent risk factors for recurrence . In patients with small incisional hernias , the recurrence rates were 67 % after suture repair and 17 % after mesh repair ( P = 0.003 ) . One hundred twenty-six patients completed long-term follow-up ( median follow-up 98 months ) . In the mesh repair group , 17 % suffered a complication , compared with 8 % in the suture repair group ( P = 0.17 ) . Abdominal pain was more frequent in suture repair patients ( P = 0.01 ) , but there was no difference in scar pain , cosmetic result , and patient satisfaction . Conclusions : Mesh repair results in a lower recurrence rate and less abdominal pain and does not result in more complications than suture repair . Suture repair of incisional hernia should be ab and oned",
"Background Kugel repair , a minimally invasive technique , has become an alternative to laparoscopic groin hernia repair , but the technique has not been adequately evaluated by assessment of objective parameters . A prospect i ve r and omized clinical study was carried out to compare the systemic inflammatory response to surgical trauma and clinical outcomes in patients who underwent groin hernia repair by the Kugel and totally extraperitoneal ( TEP ) laparoscopic methods . Methods Forty consecutive patients admitted for unilateral groin hernia were r and omized to Kugel ( n = 20 ) or TEP ( n = 20 ) repair under general anesthesia . Operation time , length of hospital stay , pain severity , time to return to normal activities , cost , and systemic inflammatory and hormone responses to surgical trauma were compared . Results There were no significant between-group differences in duration of operation , length of hospital stay , time to return to normal activities , or mean visual analogue scale ( VAS ) score ( p > 0.05 for each ) . Serum cortisol , high-sensitivity C-reactive protein ( hsCRP ) , and interleukin (IL)-6 concentrations before surgery , and 1 and 24 h after surgery , did not differ significantly in the two groups ( p > 0.05 ) . There were no recurrences or complications during follow-up . Cost per patient was US $ 546 lower in the Kugel group . Conclusion Kugel herniorrhaphy is a minimally invasive technique that offers all the advantages of TEP and is more cost-effective",
"Background In previous comparisons of inflammatory and stress responses to open ( OR ) and laparoscopic ( LR ) hernia repair , all operations were performed under general anesthesia . Since local anesthesia is widely used for OR , a comparison of this approach with LR seemed relevant . Methods Patients with recurrent inguinal hernia were r and omized to OR under local anesthesia ( n = 30 ) or LR under general anesthesia ( n = 31 ) . The magnitude of the surgical trauma was assessed by measuring markers of coagulation ( prothrombin fragment 1 + 2 ) , endothelial activation ( von Willebr and factor ) , inflammation [ leukocytes , interleukin-6 , -8 and -10 , granulocyte macrophage colony-stimulating factor , and C-reactive protein ( CRP ) ] , and endocrine stress ( cortisol ) in blood collected before operation , 4 h postincision , and on postoperative day 2 . Results Leukocyte counts and interleukin-6 and CRP levels increased in both groups , with the CRP increase being significantly greater in the OR group . The other markers did not increase significantly . Conclusion The acute phase response was more pronounced after OR , even when this was done under local anesthesia . Both techniques seemed rather atraumatic",
"Background This study aim ed to compare laparoendoscopic single-site ( LESS ) total extraperitoneal ( TEP ) repair with conventional laparoscopic TEP repair for the treatment of inguinal hernias . To date , no other studies have compared the LESS and conventional laparoscopic TEP approaches for the treatment of inguinal hernia in a prospect i ve r and omized study setting . Methods For this study , 100 patients undergoing inguinal hernia repair were prospect ively r and omized into either the LESS TEP group or the conventional laparoscopic TEP group . Pre- , intra- , and postoperative factors were recorded . The primary end point was postoperative pain . The patients were interviewed at outpatient clinics at 1 week , 3 months , and 6 months postoperatively . Results The demographic data were comparable between the two groups . The median operative time was longer in the LESS TEP group ( 63.5 min ) than in the conventional TEP group ( 50.5 min ) ( p = 0.001 ) . No conversion was performed in either group . The mean pain score 2 h postoperatively during rest was significantly higher in the conventional TEP group than in the LESS TEP group ( 3.9 vs. 2.6 ; p = 0.02 ) . The postoperative results were comparable between the groups in terms of analgesic requirements , systemic stress responses , complications , and postoperative convalescence . Conclusions The LESS TEP technique is associated with a longer operative time but offers the minor benefit of a reduction in immediate postoperative pain",
"Over the past decade , hernia surgery has undergone a considerable transformation with the use of prosthetic material s. The most used polypropylene meshes induce a rapid acute inflammatory response followed by chronic foreign body reaction . Many factors influence this response such as density , size , physical characteristics , different texture and porosity of each bio material . The aim of this study is to assess whether the implant of monofilament or multifilament meshes , in the inguinal hernioplasty , determine a different inflammatory response . Thirty-two male patients were included in the study and were r and omly divided into two groups . In the first group ( MO ) inguinal hernioplasty was performed using monofilament polypropylene mesh , while in the second one ( MU ) multifilament prosthesis was used . Peripheral venous blood sample s were collected 24 hours before surgery and then 6,24,48 and 168 hours posto-peratively . Modifications in leukocyte count , C-reactive protein ( CRP ) , alpha-1 antitrypsin ( α1-AT ) , interleukin (IL)-1 , IL-6 , IL-1 ra and IL-10 serum levels were recorded at all sampling times . We present evidence that serum levels of CRP , ( α1-AT ) , leukocytes and cytokines were significantly increased post-operatively in both groups , returning to basal values 168 hours afterwards . In particular , the production of all pro-inflammatory mediators was higher in the MU group , whereas the anti-inflammatory cytokine ( IL-10 , IL-1ra ) production was higher in MO patients . Our results indicate that polypropylene multifilament mesh allows a higher intense acute inflammatory response as compared to monofilament mesh implantation ",
"The aim of the study was to analyze the acute inflammatory response after implantation of a heavyweight mesh of polypropylene ( PP ) compared with a composite mesh of light PP and polyglactin 910 ( PG ) in patients undergoing inguinal hernioplasty . A total of 30 male patients with inguinal hernia were included in the study and divided into 2 groups ( PP and PP-PG ) according to the mesh used . Changes of leukocytes , cytokines , growth factors , and acute phase proteins were evaluated in the sera . Leukocytes and acute phase proteins were significantly increased postoperatively in both groups , and the values were slightly higher in the PP group . Cytokine levels were significantly increased postoperatively in both groups ; a slight increase was observed in the PP-PG group , especially for the proinflammatory cytokine . Growth factors decreased significantly in both groups immediately after surgery . The authors found that the use of the mesh is a stimulator of inflammatory response , and the 2 types of mesh induce a similar inflammatory response",
"Background Angiogenesis is strongly influenced by vascular endothelial growth factor ( VEGF ) and basic fibroblast growth factor ( b-FGF ) , whose production is also regulated by interferon (IFN)-γ and interleukin (IL)-10 . The aim of this study was to evaluate the modifications of serum VEGF , b-FGF , IFN-γ and IL-10 levels in patients with inguinal hernia undergoing hernioplasty with the Lichtenstein technique ( LH ) using polypropylene mesh or with Bassini open conventional inguinal hernia repair ( BH ) . Material s and methods R and omly , 16 patients underwent BH , and 16 were treated with the LH technique using polypropylene mesh . Blood sample s were collected 24 h prior to surgery and then 6 , 24 , 48 and 168 h postoperatively . The serum concentrations of VEGF , b-FGF , IFN-γ and IL-10 were evaluated . Results In BH patients , a peak of VEGF synthesis at 6 h with a normalization of this parameter 24 h after surgery has been observed . In the same subjects , b-FGF synthesis increased after surgery reaching significant levels 48 h later . On the contrary , in LH patients , a decrease in the serum VEGF and b-FGF concentrations was detected after surgery and their increase afterwards . IL-10 was increased in both groups 6 h after operation and declined to preoperative levels 24 h afterwards . IFN-γ enhanced in LH patients 6 h after surgery , whereas no modifications were detected in BH subjects . Conclusions This preliminary study shows that VEGF and b-FGF modifications , associated with alterations of cytokine secretion , are detectable in human undergoing hernioplasty , and suggests that they could somehow influence in the wound-healing process",
"Background : Although laparoscopic hernia repair has been shown to be associated with less postoperative pain and an earlier recovery , there is still controversy about its role in hernia surgery . In general , laparoscopy produces less trauma to tissues than open surgery . This has been reflected by the reduced acute phase inflammatory response observed after laparoscopic surgery compared to open surgery in various setting s , such as cholecystectomy or hysterectomy . The aim of this study was to evaluate the acute phase response after bilateral hernia repair by comparing the open Stoppa procedure with the laparoscopic totally extraperitoneal prosthetic repair ( TEPP ) . Methods : Patients were r and omly allocated to either technique after written informed consent was obtained . Measurements were made of complete blood count , erythrocyte sedimentation rate ( ESR ) , C-reactive protein ( CRP ) , interleukin-1b ( IL-1b ) , IL-6 , and tumor necrosis factor-a ( TNF-a ) preoperatively and 4 , 24 , and 48 h postoperatively . VAS pain scores , consumption of analgesics , and delay before resumption of normal activities were also recorded . All the procedures were performed under general anesthesia by or in the presence of the same surgeon . Results : Thirty-nine patients were included : 19 underwent the Stoppa procedure and 20 had a laparoscopic repair . The two groups were well matched for age , sex , ASA score , and preoperative values . The operation took longer ( p TEPP . Patients resumed their normal activities earlier ( p lymphocyte count after 4 ( p elevation of ESR after 48 h ( p = 0.02 ) ; a larger increase of IL-6 after 4 ( p = 0.05 ) , 24 ( p = 0.003 ) , and 48 h ( p CRP after 24 ( p = 0.05 ) and 48 h ( p = 0.01 ) . There was no morbidity . There was no difference in postoperative IL-1b , TNF-a , total white blood cell count , polymorphonuclear count , VAS for pain , or need for analgesics between the two groups , except on the operative day . Conclusions : The acute phase inflammatory response in clearly more active after the open Stoppa procedure than after TEPP , indicating that the former is associated with increased tissue trauma . This may play a role in the earlier recovery seen after the TEPP procedure ",
"Background The concentration of C-reactive protein ( CRP ) , a biomarker of systemic inflammation , is determined by genetic , clinical and demographic factors including gender , smoking and body mass index ( BMI ) . The influence of age on CRP dynamic changes following insult has , however , been poorly characterised . Methods We used unilateral hernia repair as a model of st and ardised insult to investigate the influence of baseline demographic and clinico-pathological factors affecting the dynamic changes in CRP , interleukin ( IL ) 6 and tumour necrosis factor-α over a time course of 48 h following injury . Results We derived CRP negativisation kinetics on 100 prospect ively enrolled male subjects with mean age of 60.6 years ( range 24–90 years ) and mean BMI of 25.7 kg/m2 ( range 17.9–37 kg/m2 ) . Patients who failed to normalise CRP to longer surgical times ( p=0.05 ) , higher waist/hip ratio ( p=0.02 ) . Multiple regression analysis confirmed age as the only independent predictor of delayed CRP normalisation ( p=0.03 ) . Persistent CRP elevation was associated with higher peak CRP values ( p higher IL-6 concentrations at 24 ( p=0.01 ) and 48 h ( p=0.03 ) . Conclusions CRP decline following insult is delayed in elderly patients as a result of unopposed IL-6 release . Age should be routinely incorporated in the assessment of CRP response to avoid misinterpretation of age-related delay in CRP clearance with ongoing systemic inflammation",
"Laparoscopic surgery may reduce the inflammatory response to surgery by the avoidance of a skin incision which is frequently the site of maximum tissue trauma . We hypothesized that the inflammatory response is less with minimally invasive procedures . The aim of this study was to evaluate the response of inflammatory mediators following laparoscopic and open hernia repair . Thirty-four patients undergoing unilateral primary inguinal hernia repair were prospect ively assigned to either laparoscopic mesh hernia repair ( n=14 ) , open mesh hernia repair ( n=11 ) , or a Bassini repair ( n=9 ) . Serum sample s withdrawn prior to surgery , 6 h after surgery , and then again at 24 h after surgery were assayed for interleukin-6 and C-reactive protein content . Interleukin-6 levels at 24 h in the laparoscopic ( 13.1±3.1 pg/ml ) , open mesh ( 15.5±2.5 pg/ml ) , or Bassini group ( 15.4±2.0 pg/ml ) did not differ significantly . Neither did C-reactive protein levels at 24 h in the laparoscopic ( 12.4±2.7 pg/ml ) , open mesh ( 23.0±7.8 pg/ml ) , or Bassini group ( 18.6±6.6 pg/ml ) differ significantly . The response of inflammatory mediators to hernia repair is not modified by undertaking the procedure laparoscopically",
"BACKGROUND The use of minimal access surgery for repair of groin hernias is controversial . The aim of this study was to compare endoscopic tension-free hernia repair with open tension-free hernia repair within a r and omized clinical trial . METHODS One hundred twenty patients were r and omized by four surgeons during a 1-year period . Early outcome measures were then analyzed by intention to treat . RESULTS Median postoperative pain scores ( 63 [ interquartile range ( IQR ) , 23 to 81 ] versus 35 [ IQR , 17 to 62 ] ; p = 0.004 ) and analgesia requirements ( 2.5 [ IQR , 2 to 4 ] doses verus 2.0 [ IQR , 1 to 3 ] doses ; p = 0.0008 ) were significantly less for patients undergoing endoscopic hernia repair . Hospital stay ( 1 [ IQR , 0 to 1 ] day versus 2 [ IQR , 1 to 2 ] days ; p Wound complications occurred significantly more frequently in the open group . No difference in pulmonary function or metabolic response to trauma ( interleukin-6 , C-reactive protein , glucose , albumin ) was observed between the groups . CONCLUSIONS This study shows significant short-term advantages for endoscopic tension-free repair over open tension-free repair . However , larger studies with a longer follow-up period are required to establish the relative merits of both procedures in the management of patients with groin hernias",
"As a tension-free repair technique , Lichtenstein operation has gained great popularity worldwide during the last decade . Expert centres do this technique using local anaesthesia in nearly 95 % of cases . However , general anaesthesia is used in many hospitals , while regional anaesthesia is preferred in some centres . To date , no study has compared different types of anesthesia in respect of inflammatory response and oxidative stress specifically . The objective of this prospect i ve study was to compare local , spinal and general types of anesthesia regarding their effects on inflammatory response and oxidative stress in Lichtenstein hernia repair . Lichtenstein hernia repair causes only a mild oxidative stress . While total WBC and neutrophil count responses fade away after 24 hours in patients who are operated under local anaesthesia , these changes in spinal and general types of anaesthesia cases stay valid at 24th hour . Spinal anaesthesia is seen to be more advantageous than local and general types of anaesthesia when C-reactive protein as an acute phase marker is considered . Total antioxidant status shows minor alterations in three types of anaesthesia , however , general anaesthesia seems to be the least reliable among them . Overall , local and spinal anaesthesia methods can be accepted as better alternatives in comparison with general anaesthesia in regard to oxidative stress ( Tab . 2 , Ref . 25 ) . Full Text ( Free , PDF ) www.bmj.sk",
"BACKGROUND The purpose of this study was to evaluate the involvement of proinflammatory cytokines ( interferon-gamma [ INF-gamma ] , interleukin [IL]-6 ) and anti-inflammatory cytokines ( IL-4 , IL-l0 , IL-13 ) in patients undergoing Lichtenstein tension-free hernioplasty ( LH ) using polypropylene prosthetic material s or conventional Bassini hernia ( BH ) repair . METHODS Thirty-five male patients ( age range 25 to 60 years ) with unilateral inguinal hernia without complications or recurrence were included in this study . R and omly , patients underwent conventional operation and had their inguinal hernia repair performed with polypropylene mesh . Peripheral venous blood sample s were collected 24 hours prior to surgery and then 6 , 24 , 48 , and 168 hours postoperatively . Fifteen healthy controls were included . RESULTS We present evidence that LH patients showed both an increased serum level of Thelper 1 (Th1)-like cytokines ( IFN-gamma ) and an increase in Thelper 2 (Th2)-like cytokines ( IL-6 and IL-l0 ) , associated with a slight reduction of peripheral blood mononuclear cells ( P BMC ) producing IL-6 and a normal level of P BMC producing IFN-gamma , IL-l0 , IL-13 , and IL-4 . Whereas BH patients showed in part an amplification of Th2-like cells , characterized by the sustained serum production of IL-6 and IL-l0 , associated with an increase in IL-l0 secreted by in vitro stimulated PMBC . CONCLUSIONS Our data show that LH is associated with a higher production of inflammatory cytokines ( IFN-gamma and IL-6 ) compared with BH , likely induced by the presence of the polypropylene prostheses",
"OBJECTIVE To see if the inflammatory responses during and after laparoscopic and open inguinal hernia repairs differed . DESIGN R and omised prospect i ve study . SETTING County hospital , Denmark . PATIENTS 18 men aged 25 - 77 years with unilateral inguinal hernias . INTERVENTIONS Ten patients had a laparoscopic repair and 8 an open tension-free repair . MAIN OUTCOME MEASURES Serum concentrations of interleukin (IL)-2 receptors ( R ) of the alpha group ( IL-2Ralpha ) , IL-6 , anti-IL-6 , IL-10 , tumour necrosis factor (TNF)-alpha , sTNF-RI and sTNF-RII before and 2 , 6 , 12 , and 24 hours after the repairs . Duration of operation and time for return to normal activities or work were also recorded . RESULTS Serum IL-6 concentrations increased significantly after operation in both groups ( p Anti-IL-6 and IL-10 remained undetectable at all time points . There were no significant differences or increases in the concentrations of TNF-alpha or sTNF-RII . However , sTNF-RI concentrations increased significantly in both groups ( p IL-2Ralpha decreased significantly in both groups ( p median operation time was 85 min ( range 55 - 100 min ) in the laparoscopic group and 52 min ( range 45 - 79 min ) in the \" open \" group ( p Median time to return to normal activities/work were 2 and 13 days after laparoscopic and open operations , respectively ( p laparoscopic inguinal hernia repair is less than that of open tension-free hernia operations as assessed by circulating mediators of the postoperative inflammatory response . The clinical relevance of this finding must be evaluated in larger r and omised studies",
"OBJECTIVE To compare systemic stress responses after laparoscopic and open hernia repair to find out if the laparoscopic approach caused less stress than an open operation . DESIGN Prospect i ve r and omised trial . SETTING Teaching hospital , Sanliurfa , Turkey . SUBJECTS 50 patients who required preperitoneal hernia repair were r and omised to be treated by either the open or laparoscopic approach ( n = 25 in each ) . INTERVENTIONS Sample s of venous blood were taken before operation and at 2 , 24 , and 48 hours afterwards for measurement of the concentrations of : glucose , cortisol , malonyldialdehyde ( MDA ) , C-reactive protein ( CRP ) , creatine phosphokinase ( CPK ) , caeruloplasmin , transferrin , fibrinogen , and albumin , and counts of leucocytes , neutrophils , and lymphocytes . MAIN OUTCOME MEASURES Changes in these indicators of a stress response . RESULTS Concentrations of glucose , cortisol , CRP , MDA , and CPK , and counts of leucocytes and neutrophils increased significantly , and the concentration of albumin decreased significantly , in both groups postoperatively . Lymphocyte counts were lower postoperatively but not significantly so . Concentrations of CRP , MDA , and CPK , and leucocyte counts were significantly lower in the laparoscopic group . CONCLUSION These findings suggest that there is less systemic stress response after laparoscopic than after open hernia repair ",
"BACKGROUND : The present clinical trial was design ed to compare the results of bilateral inguinal hernia repair between patients who underwent the conventional Stoppa technique and laparoscopic total extraperitoneal repair ( LTE ) with a single mesh and without staple fixation . PATIENTS AND METHODS : This controlled , r and omised clinical trial was conducted at General Surgery and Trauma of the Clinics Hospital , Medical School , the University of São Paulo between September 2010 and February 2011 . Totally , 50 male patients , with a bilateral inguinal hernia , older than 25 years were considered eligible for the study . The following parameters were analysed during the early post-operative period : ( 1 ) The intensity of surgical trauma , operation time , C-reactive protein ( CRP ) levels , white blood cell count , bleeding and pain intensity ; ( 2 ) quality of life assessment ; and ( 3 ) post-operative complications . RESULTS : LTE procedure was longer than the Stoppa procedure ( 134.6 min ± 38.3 vs. 90.6 min ± 41.3 ; P The levels of CRP were higher in the Stoppa group ( P number of leucocytes , haematocrit , and haemoglobin were similar between the groups ( P > 0.05 ) . There was no difference in pain during the 1st and 7th post-operative , physical functioning , physical limitation , the impact of pain on daily activities , and the Carolinas Comfort Scale during the 7th and 15th post-operative ( P > 0.05 ) . Complications occurred in 88 % of Stoppa group ( 22 patients ) and 64 % in LTE group ( 16 patients ) ( P Quality of life during the early post-operative period were similar ; and ( 3 ) Complication rates were higher in the Stoppa group",
"Background This study evaluated the role of the acute phase C-reactive protein ( CRP ) in the postoperative course of a large series of rectal resections on the basis of a prospect i ve data base . Main focus of this study was the early identification of complications . Material s and methods Three hundred eighty-three rectal resections with primary anastomosis for rectal cancer were screened for infectious postoperative complications . Forty-eight complicated cases were identified and matched with 48 patients with an uneventful postoperative course . Results In the postoperative setting , CRP peaked on postoperative day ( POD ) 2 with a median serum CRP of 140 mg/l and gradually declined thereafter in uncomplicated cases . In complicated cases , CRP elevation generally persisted after POD 2 , whereas white blood cells and body temperature were within normal range in the early postoperative period . A cutoff CRP value of 140 mg/dl on PODs 3 and 4 result ed in predictive values of 85.7 and 90.5 % ( adjusted to the prevalence : 37.6 and 50.3 % ) , sensitivities of 80.0 and 54.3 % , and specificities of 81.0 and 92.3 % for a complicated postoperative course ( P Persistent CRP elevation and elevation of serum CRP above 140 mg/dl on PODs 3–4 are predictive of infectious postoperative complications and should prompt intense clinical search for an inflammatory process , especially for an anastomotic leak if pneumonia and wound infection are unlikely or excluded",
"AIM OF THE STUDY To evaluate the early effect of inguinal hernia repair by the tension-free method compared to the conventional And rew 's technique on lipid peroxidation . PATIENTS - METHODS Thirty-four patients subjected to elective hernia repair were enrolled in the study divided in two groups . Group A ( n=18 ) underwent hernia repair by the tension-free method using a polypropylene mesh . Group B ( n=16 ) underwent hernia repair by the And rew 's technique ( i.e. a modification of the Bassini 's technique ) . Venous blood sample s were drawn preoperatively and at 12 , 24 and 48 h postoperatively . Malondialdehyde ( MDA ) was estimated by the thiobarbiturate assay . RESULTS Neutrophil counts were significantly higher in patients of group B compared to group A at 12 and 48 h postoperatively . Concentrations of fibrinogen were similar between the two groups . MDA was significantly higher in patients of group B hours compared to group A at 12 , 24 and 48 h postoperatively . Positive correlation was found between neutrophil counts and MDA at 12 h ( r : + 0.43 , P : 0.015 ) and 48 h ( r : + 0.496 , P : 0.005 ) but not at 24 h. No correlation was found between serum fibrinogen and MDA . CONCLUSION Hernia repair by the And rews 's technique elicits a sustained triggering of lipid peroxidation , compared to the tension-free method"
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ABSTRACT Objective : To provide clinicians and research ers information regarding ( 1 ) the existing outcome measures to assess the loss of functionality in the activities of daily living ( ADLs ) of patients with stroke and ( 2 ) the presence of these assessment tools in the Italian context . Study Design and Setting : For this Systematic Review Medline , CINAHL , and PsycINFO were search ed for articles published up to 4 July 2017 . Two authors independently identified eligible studies on the basis of predefined inclusion criteria and extracted data . Study quality and risk of bias were assessed using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies . Results : Of 370 publications identified and screened , 46 studies fell within the inclusion criteria and were critically review ed . The most commonly used tools were : the Frenchay Activities Index and the Functional Independence Measure . Conclusion : This review has emphasized the need for agreement among research ers as to which tool must be studied in depth or adapted to other national context s in order to develop universal norms and st and ards | [
"Background and Purpose — This study describes the development of a Rasch-built scale measuring activity limitations in stroke patients , named ACTIVLIM-Stroke . Method — This new Rasch-built measure was constructed based on stroke patients ' perceptions of difficulty in performing daily activities . Patients were recruited from inpatient and outpatient rehabilitation departments in Belgium and Benin . A 73-item question naire was completed by 204 participants . A r and om sub sample of 83 subjects was given the question naire a second time . Data were analyzed using RUMM2030 software . Results — After successive Rasch analyses , the ACTIVLIM-Stroke question naire , a unidimensional and linear 20-item measure of activity limitations , was constructed . All 20 items fulfilled Rasch requirements ( overall and individual item fit , category discrimination , invariance , local response independence , and nonredundancy in item difficulty ) . This simple patient-based scale encompasses a large range of activities related to self-care , transfer , mobility , manual ability , and balance . The ACTIVLIM-Stroke question naire exhibited high internal validity , excellent internal consistency , and good crosscultural validity . The test – retest reliability of item difficulty hierarchy ( intraclass correlation coefficient=0.99 ) and patient location ( intraclass correlation coefficient=0.92 ) were both excellent . Furthermore , it showed good external construct validity using correlations with the Functional Independence Measure motor and the Barthel Index and a higher discriminating capacity than either of these widely used indices . Conclusions — The ACTIVLIM-Stroke question naire has good psychometric qualities and provides accurate measures of activity limitations in patients with stroke . It is recommended for evaluating clinical and research interventions in patients with stroke , because it provides a higher discrimination and might be more sensitive to change",
"Background and Purpose — The Motor Activity Log ( MAL ) is a semistructured interview for hemiparetic stroke patients to assess the use of their paretic arm and h and ( amount of use [ AOU ] ) and quality of movement [ QOM ] ) during activities of daily living . Scores range from 0 to 5 . The following clinimetric properties of the MAL were quantified : internal consistency ( Cronbach α ) , test – retest agreement ( Bl and and Altman method ) , cross-sectional construct validity ( correlation between AOU and QOM and with the Action Research Arm [ ARA ] test ) , longitudinal construct validity ( correlation of change on the MAL during the intervention with a global change rating [ GCR ] and with change on the ARA ) , and responsiveness ( effect size ) . Methods — Two baseline measurements 2 weeks apart and 1 follow-up measurement immediately after 2 weeks of intensive exercise therapy either with or without immobilization of the unimpaired arm ( forced use ) were performed in 56 chronic stroke patients . Results — Internal consistency was high ( AOU : α=0.88 ; QOM : α=0.91 ) . The limits of agreement were −0.70 to 0.85 and −0.61 to 0.71 for AOU and QOM , respectively . The correlation with the ARA score ( Spearman ρ ) was 0.63 ( AOU and QOM ) . However , the improvement on the MAL during the intervention was only weakly related to the GCR and to the improvement on the ARA , Spearman ρ was between 0.16 and 0.22 . The responsiveness ratio was 1.9 ( AOU ) and 2.0 ( QOM ) . Conclusion — The MAL is internally consistent and relatively stable in chronic stroke patients not undergoing an intervention . The cross-sectional construct validity of the MAL is reasonable , but the results raise doubt about its longitudinal construct validity",
"Background The Barthel Index ( BI ) assesses actual performance of activities of daily living ( ADL ) . However , comprehensive assessment of ADL functions should include two other constructs : self-perceived difficulty and ability . Objective The aims of this study were to develop two BI-based Supplementary Scales ( BI-SS ) , namely , the Self-perceived Difficulty Scale and the Ability Scale , and to examine the construct validity of the BI-SS in patients with stroke . Method The BI-SS was first developed by consultation with experts and then tested on patients to confirm the clarity and feasibility of administration . A total of 306 participants participated in the construct validity study . Construct validity was investigated using Mokken scale analysis and analyzing associations between scales . The agreement between each pair of the scales ’ scores was further examined . Results The Self-perceived Difficulty Scale consisted of 10 items , and the Ability Scale included 8 items ( excluding both bladder and bowel control items ) . Items in each individual scale were unidimensional ( H≥0.5 ) . The scores of the Self-perceived Difficulty and Ability Scales were highly correlated with those of the BI ( rho = 0.78 and 0.90 , respectively ) . The scores of the two BI-SS scales and BI were significantly different from each other ( p patients with stroke . The BI-SS can be used as supplementary scales for the BI to comprehensively assess patients ’ ADL functions in order to identify patients ’ difficulties in performing ADL tasks , plan intervention strategies , and assess outcomes",
"Objective : To establish the structural validity of the Chinese version of the Modified Barthel Index and to estimate its inter-rater reliability for use with patients who have had a stroke . Design : Prospect i ve study . Setting : A regional general hospital and a day hospital in Hong Kong . Subjects : One hundred and sixteen older people who had had a stroke ( mean age 76.0 ; SD 7.6 ) were involved in the establishment of evidence of the structural validity and item quality . Another 15 older people with stroke ( mean age 78.0 ; SD 7.1 ) participated in estimating the reliability of the instrument . Methods and results : The Modified Barthel Index was translated into Chinese . Factor analyses revealed a two-factor structure that explained 75.7 % of the total variance . Factor 1 was found to consist of eight items relating to patients ' functional performance . Factor 2 consisted of the two items that focused on patients ' ` physiological needs ' . The test — retest reliability of the Chinese version at the item level was comparable with that of the original version , with kappa statistics ranging from 0.63 to 1.00 ( P Barthel Index ( MBI-C ) seems to be valid and reliable for use with older people with stroke . Changes were made to the item content and the rating criteria that were specific to Chinese culture . The structural validity and the reliability of the Chinese version were shown to be robust across the original and Chinese groups",
"Objective : To research test – retest reliability and discriminant validity of the Canadian Occupational Performance Measure ( COPM ) , a client-centred outcome measure , in stroke patients . Design : The COPM was administered twice with a mean interval of eight days ( SD 2.5 , range 5–16 ) . On both occasions the patient identified a maximum of five problems in daily activities . The problems of both interviews were compared . The problems identified during the first COPM were rated by the patient on a performance and satisfaction rating scale on both occasions . The individually identified items with use of the client-centred COPM were compared with the fixed items of st and ardized measures ( Barthel Index , Frenchay Activities Index , Stroke Adapted Sickness Impact Profile-30 , Euroqol 5D and Rankin Scale ) . Setting : Patients were interviewed at their place of residence . Subjects : Twenty-six stroke patients participated , 11 men and 15 women , aged from 26 to 83 years ( mean 68 , SD 15 ) . Twenty-four patients were six months , two patients were two months post stroke . Results : Of the 115 problems identified during the first COPM , 64 ( 56 % ) were also identified the second time . Correlation coefficients for the scores were 0.89 ( p performance and 0.88 ( p satisfaction . Of the individual problems identified with the COPM , 25 % or less were present in the st and ardized measures . Correlations between the scores on the COPM and the st and ardized measures were low and nonsignificant , while all st and ardized measures correlated significantly with each other . Conclusions : Test – retest reliability of the COPM was moderate for the item pool but was good for the performance and satisfaction scores . Discriminant validity was confirmed . Many patient-unique problems identified with the COPM were not evaluated by st and ardized measures",
"Objective . To evaluate the Extended Barthel Index with acute ischemic stroke patients . Methods . This prospect i ve 1- to 6-week poststroke follow-up study was carried out using 33 newly diagnosed acute ischemic stroke patients who were admitted to the University Medical Centre Ljubljana , Department of Neurology . Measures used were Barthel Index ( BI ) , Extended Barthel Index ( EBI ) , Fugl Meyer Motor Impairment Scale , 1 - 5 Self- assessment scale , Rivermead Behavioural Memory Test . Results . The EBI is a reliable scale in terms of internal consistency . The cognitive part is less reliable than the physical part of the EBI . It is a 3-dimensional scale as calculated by factor analysis ( factor 1 with eigenvalue 8.2 , factor 2 with eigenvalue 2.7 and factor 3 with eigenvalue 0.9 ) . Criterion validity to the BI and and the Fugl-Meyer Motor Impairment scale was supported ( P = 0.1 - 0.001 ) . External validity to the Self- Assessment scale was also supported ( P sensitive to the changes in functional status that occur in the 1st 6 weeks poststroke than the original BI , although the ceiling effect was not really explained in this follow-up period . Conclusion . The EBI is a valid , reliable , 2- to 3-dimensional outcome measure of disability/activity for stroke patients . To some extent , it also reveals the level of patients ’ perception of their functional status"
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Enhanced recovery programs ( ERPs ) have been shown to improve postoperative outcomes after abdominal surgery . This study aim ed to review the current literature to assess if ERPs in colorectal , pancreas , and liver surgery induce cost savings . A systematic review was performed including prospect i ve and retrospective studies comparing conventional management versus ERP in terms of costs . All kinds of ERP were considered ( fast-track , ERAS ® , or home-made protocol s ) . Studies with no mention of a clear protocol and no reporting of protocol compliance were excluded . Thirty-seven articles out of 144 identified records were scrutinized as full articles . Final analysis included 16 studies . In colorectal surgery , two studies were prospect i ve ( 1 r and omized controlled trial , RCT ) and six retrospective , totaling 1277 non-ERP patients and 2078 ERP patients . Three of the eight studies showed no difference in cost savings between the two groups . The meta- analysis found a mean cost reduction of USD3010 ( 95 % CI : 5370–650 , p = 0.01 ) in favor of ERP . Among the five included studies in pancreas surgery ( all retrospective , 552 non-ERP vs. 348 ERP patients ) , the mean cost reduction in favor of the ERP group was USD7020 ( 95 % CI : 11,600–2430 , p = 0.003 ) . In liver surgery , only three studies ( two retrospective and 1 RCT , 180 non-ERP vs. 197 ERP patients ) were found , which precluded a sound cost analysis . The present systematic review suggests that ERPs in colorectal and pancreas surgery are associated with cost savings compared to conventional perioperative management . Cost data in liver surgery are scarce | [
"BACKGROUND Perioperative treatment of patients with colorectal cancer according to the Enhanced Recovery After Surgery ( ERAS ) protocol has proven to reduce complications and duration of stay . However , strict adherence remains a challenge and the benefits may decrease with lower adherence . In this study , we report on 8 years of adherence to the ERAS protocol and its effect on postoperative outcome in patients with colon cancer . METHODS In 2006 , the ERAS protocol was introduced for treatment of colon cancer patients in the Medical Center Alkmaar , a large teaching hospital . Patients scheduled for elective colon cancer resection were included in this study . Adherence to ERAS items was monitored and along with clinical data prospect ively gathered in a data base . In 2011 , several measures to improve adherence were implemented . RESULTS In total , 816 patients were included . Mean adherence rate was 73 % in 2006 and 2007 , 66 % in 2008 and 2009 , 63 % in 2010 and 2011 , and 82 % in 2012 and 2013 . There was a shorter duration of stay in the years with high adherence ( 5.7 days ) compared with the years with low adherence ( 7.3 days ; P shorter duration of stay were no nasogastric tube , early mobilization , early oral nutrition , early removal of epidural , early removal of catheter , and nonopioid oral analgesia . CONCLUSION It is possible to improve adherence to the ERAS protocol and related outcomes with specific measures . Adherence to the ERAS protocol was related inversely to duration of stay . Only postoperative items of the ERAS protocol were predictive for a shorter duration of stay . Keeping adherence optimal remains an ongoing challenge that requires repeated training and dedicated personnel",
"The aim of this trial was to compare multimodal optimization with conventional perioperative management in a consecutive series of patients undergoing a wide range of colorectal procedures",
" Objective Optimizing peri‐operative care using an enhanced recovery programme improves short‐term outcomes following colonic resection . This study compared a prospect i ve group of patients undergoing resection of colorectal cancer within an enhanced recovery programme , with a prospect ively studied historic cohort receiving conventional care",
"BACKGROUND There are few data describing successful institutional \" conversion \" from open colectomy/st and ard care techniques to laparoscopic colectomy/fast-track care . PURPOSE To assess the benefits of transitioning an institution from open to laparoscopic colectomy with fast-track care while avoiding a learning curve . METHOD Twenty consecutive laparoscopic colorectal resections ( LCRs ) performed by a colorectal surgeon were compared with 20 matched open colorectal resections ( OCRs ) performed by general surgeons before the arrival of the colorectal surgeon . RESULTS Surgical procedures were as follows : sigmoidectomy : OCR 16 and LCR 11 ; right colectomy : OCR 3 and LCR 8 ; and total colectomy : OCR 1 and LCR 1 . The mean operative time for sigmoidectomy was 250 and 109 minutes for OCR and LCR , respectively , and for right colectomy 181 and 97 minutes for OCR and LCR , respectively ( P Morbidity was OCR 45 % versus LCR 25 % . There was no mortality . LCR showed significantly lower length of stay and direct cost ( 3.6 vs. 8.3 days ; 4,993 dollars vs. 11,383 dollars ; both P < .001 ) . CONCLUSIONS The data clearly show an institutional benefit for the implementation of specialty-based advanced laparoscopic procedures",
"A fast-track clinical pathway is design ed to streamline patient care delivery and maximize cost effectiveness . It has decreased postoperative length of stay ( LOS ) and hospital charges for many surgical procedures . However , data on clinical pathways after liver surgery are sparse . This study examined whether use of a fast-track clinical pathway for patients undergoing elective liver resection affected postoperative LOS and hospital charges . A fast-track clinical pathway was developed and implemented by a multidisciplinary team for patients undergoing liver resection . Between July , 2007 and May , 2008 , a total of 117 patients underwent elective liver resection : the fast-track clinical pathway ( education of patients and families , earlier oral feeding , earlier discontinuation of intravenous fluid , no drains or nasogastric tubes , early ambulation , use of a urinary catheter for less than 24 h and planned discharge 6 days after surgery ) was studied prospect ively in 56 patients ( postpathway group ) . These patients were compared with the remainder who had usual care ( prepathway group ) . Outcome measures were postoperative LOS , perioperative hospital charges , intraoperative and postoperative complications , mortality , and readmission rate . Among all patients , 69 ( 59 % ) had complicating diseases and /or a history of surgery and 24 patients belonged to American Society of Anesthesiologists grade III – IV . Compared with the prepathway group , the postpathway group had a significantly shorter postoperative LOS ( 7 vs. 11 days , P average perioperative hospital charges were RMB 26,626 for patients in the prepathway group and only RMB 21,004 for those in the postpathway group ( P in intraoperative and postoperative complications ( P = 0.814 ) , mortality ( P = 0.606 ) , and readmission rate ( P = 0.424 ) . Implementation of the fast-track clinical pathway is an effective and safe method for reducing postoperative LOS and hospital charges for high-risk patients undergoing elective liver resection . The result supports the further development of fast-track clinical pathways for liver surgical procedures",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"Enhanced recovery after surgery ( ERAS ) pathways have been associated with improved perioperative outcomes following several surgical procedures . Less is known , however , regarding their use following hepatic surgery",
"Background The aim of this trial was to compare the Enhanced Recovery After Surgery ( ERAS ) program with conventional perioperative management in patients who underwent radical resection for colorectal cancer . Methods A combination of evidence -based and consensus methodology was used to develop the ERAS protocol . Five hundred ninety-seven consecutive patients who underwent elective colorectal resection were r and omized to either the ERAS ( n = 299 ) or the control group ( n = 298 ) . Outcomes relating to nutrition and metabolism index , stress index , and recovery index were measured and recorded . Results Demographic and operative data were similar between the two groups . Patients in the ERAS group showed improved nutritional status when compared with those of the control group . On postoperative day ( POD ) 1 , the HOMA-IR ( insulin resistance index ) of the ERAS group was lower than that of the control group ( p The cortisol level of the control group was elevated on both POD 1 ( p = 0.007 ) and POD 5 ( p = 0.002 ) compared to the preoperative level . However , the cortisol level of the ERAS group was not increased until POD 5 ( p = 0.001 ) . Reduced levels of TNF-α , IL-1β , IL-6 , and IFN-γ in the ERAS group indicated less postoperative stress responses . In addition , ERAS was associated with accelerated recovery of gastrointestinal function . The postoperative length of stay ( p ERAS protocol attenuates the surgical stress response and accelerates postoperative recovery without compromising patient safety",
"IMPORTANCE Enhanced recovery after surgery ( ERAS ) colorectal programs have shown to be successful at reducing length of stay in many international and academic centers ; however , their efficacy in a community hospital setting remains unclear . OBJECTIVE To determine if favorable results could be reproduced in a community hospital setting using our ERAS program , which was developed using core ERAS guidelines with the goal of accelerated recovery while also addressing other important outcomes affecting patient experience and safety . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve study of ERAS program , a multidisciplinary effort involving anesthesia , preadmission staff , nursing , and surgery staff at a community hospital . The program was initiated in 2010 and was in full practice by 2011 . We assessed practice patterns and patient outcomes for all elective colon and rectal resection cases performed in 2009 ( prior to ERAS implementation ) , 2011 , and 2012 . MAIN OUTCOMES AND MEASURES Laparoscopic approach , narcotic use , length of stay , 30-day readmission , ileus ( defined as reinsertion of nasogastric tube ) , and intra-abdominal infection and association between colorectal cancer ( CRC ) diagnosis and these outcomes . RESULTS From 2009 to 2012 , the use of laparoscopy increased from 57.4 % to 88.8 % ( P Length of stay decreased significantly ( 6.7 days vs 3.7 days , P 30-day readmission rate ( 17.6 % vs 12.5 % , P = .49 ) . Use of patient-controlled narcotic analgesia and duration of use decreased ( 63.2 % of patients vs 15 % , P Ileus rate decreased from 13.2 % to 2.5 % ( P = .02 ) . Intra-abdominal infection decreased from 7.4 % to 2.5 % ( P = .24 ) . When comparing laparoscopic cases alone , similar results were observed . Following regression analysis , there were no statistically significant differences between CRC diagnosis and LOS , 30-day readmission rates , ileus , and intra-abdominal infection ( all P 's > .05 ) . Length of stay reductions result ed in an estimated cost savings of $ 3202 per patient ( 2011 ) and $ 4803 per patient ( 2012 ) . CONCLUSIONS AND RELEVANCE Implementation of this patient care-directed enhanced recovery program is feasible in a community hospital setting , and it is associated with decreased LOS without increased readmission or morbidity , as well as significant decreases in narcotic use and cost . Improved outcomes are independent of the laparoscopic approach and CRC diagnosis",
"PURPOSE Patients with pneumonia often remain hospitalized after becoming clinical ly stable , without demonstrated benefits on outcome . The purpose s of this study were to assess the relation between length of hospital stay and daily medical care costs and to estimate the potential cost savings associated with a reduced length of stay for patients with pneumonia . SUBJECTS AND METHODS As part of a prospect i ve study of adults hospitalized with community-acquired pneumonia at a community hospital and two university teaching hospitals , daily medical care costs were estimated by multiplying individual charges by department-specific cost-to-charge ratios obtained from each hospital 's Medicare cost reports . RESULTS The median total cost of hospitalization for all 982 in patients was $ 5 , 942 , with a median daily cost of $ 836 , including $ 491 ( 59 % ) for room and $ 345 ( 41 % ) for non-room costs . Average daily non-room costs were 282 % greater on the first hospital day , 59 % greater on the second day , and 19 % greater on the third day than the average daily cost throughout the hospitalization ( all P Average daily room costs remained relatively constant throughout the hospital stay , with the exception of the day of discharge . A projected mean savings of $ 680 was associated with a 1-day reduction in length of stay . CONCLUSIONS Despite institutional differences in total costs , patterns of daily re source use throughout hospitalization were similar at all institutions . A 1-day reduction in length of stay might yield substantial cost-savings",
"Objective : To investigate which perioperative treatment , ie , laparoscopic or open surgery combined with fast track ( FT ) or st and ard care , is the optimal approach for patients undergoing segmental resection for colon cancer . Summary Background Data : Important developments in elective colorectal surgery are the introduction of laparoscopy and implementation of FT care , both focusing on faster recovery . Methods : In a 9-center trial , patients eligible for segmental colectomy were r and omized to laparoscopic or open colectomy , and to FT or st and ard care , result ing in 4 treatment groups . Primary outcome was total postoperative hospital stay ( THS ) . Secondary outcomes were postoperative hospital stay ( PHS ) , morbidity , reoperation rate , readmission rate , in-hospital mortality , quality of life at 2 and 4 weeks , patient satisfaction and in-hospital costs . Four hundred patients were required to find a minimum difference of 1 day in hospital stay . Results : Median THS in the laparoscopic/FT group was 5 ( interquar-tile range : 4–8 ) days ; open/FT 7 ( 5–11 ) days ; laparoscopic/st and ard 6 ( 4.5–9.5 ) days , and open/st and ard 7 ( 6–13 ) days ( P Median PHS in the laparoscopic/FT group was 5 ( 4–7 ) days ; open/FT 6 ( 4.5–10 ) days ; laparoscopic/st and ard 6 ( 4–8.5 ) days and open/st and ard 7 ( 6–10.5 ) days ( P reduce hospital stay and morbidity . Conclusions : Optimal perioperative treatment for patients requiring segmental colectomy for colon cancer is laparoscopic resection embedded in a FT program . If open surgery is applied , it is preferentially done in FT care . This study was registered under NTR222 ( www.trialregister.nl )",
"BACKGROUND Clinical pathways are increasingly being used by hospitals to improve efficiency in the care of certain patient population s ; however , little prospect i ve data are available to support their use . This study examined whether using a clinical pathway for patients undergoing ileal pouch/anal anastomosis , a complex procedure in which we had extensive practical experience , affected hospital charges or length of stay ( LOS ) . METHODS A clinical pathway was developed to serve patients undergoing elective total colectomy and ileal pouch/anal anastomosis . All operations were performed by two attending physicians ( J.E.F. , M.S.N. ) . Before implementation , 10 pilot patients were prospect ively monitored to ensure that hospital charges were accurately generated . In addition , charge audits were performed by an outside agency to verify the accuracy of the hospital bills . The pathway was then implemented , and 14 patients were prospect ively analyzed . RESULTS In all patients the principal diagnosis was ulcerative colitis , with the exception of three patients with familial polyposis . Mean external audit charges were within 2 % of the hospital bills ; therefore the hospital bills were used in all calculations . The mean LOS decreased from 10.3 days to 7.5 days ( p = 0.046 ) for patients on the pathway versus pilot patients . Mean hospital charges also decreased significantly , from $ 21,650 to $ 17,958 per patient ( p = 0.005 ) . CONCLUSIONS Implementation of a clinical pathway , even for an operation in which the surgeon has much experience , is an effective method for reducing LOS and charges for patients . This is likely the result of interdisciplinary cooperation , elimination of unnecessary interventions , and streamlined involvement of ancillary services . These results support the development of clinical pathways for procedures that involve routine preoperative and postoperative care . In addition , the benefits of clinical pathways should increase proportionally with increasing case volume for a particular procedure",
"Objective To analyze the results after the introduction of enhanced recovery after surgery ( ERAS ) protocol s , a r and omized study was performed to compare the outcomes of laparoscopic hepatectomy under ERAS or traditional care . Methods Patients undergoing laparoscopic hepatectomy from April 2014 to October 2014 were included and r and omly divided into Control group ( CG ) and ERAS . Primary outcome was quality of life ( QoL ) and length of hospital stay ( LOS ) . Secondary endpoints were percentage readmission , mortality , duration to first flatus , complications , hospital costs , conversions and blood loss . Results Thirteen patients withdrew after r and omization . Eighty-six patients completed the study , 48 ERAS and 38 CG . Postoperative LOS was significantly reduced in ERAS [ 6 ( 4–8 ) versus 10 ( 7–15 ) days , P = 0.04 ] . First flatus occurred earlier in ERAS than CG [ 2(1–4 ) versus 3(2–5 ) days , P = 0.02 ] . The average perioperative charges were 9470 ± 1540 in CG and only 7742 ± 1200 in ERAS ( P = 0.03 ) , with no differences in readmission rate , blood loss , conversions to open surgery , mortality or surgical complications . The median AUC ( area under a curve ) of QoL was considerably improved in ERAS ( P = 0.04 ) . Conclusions This study suggests that ERAS is feasible and safe for laparoscopic hepatectomy",
"BACKGROUND There is increasing interest in implementing comprehensive perioperative protocol s , including preoperative optimization and education , perioperative goal -directed fluid management , and postoperative fast tracking , to enhance recovery after surgery . Data on the outcomes of these protocol s in pancreatic surgery , however , are limited . STUDY DESIGN A retrospective review of a prospect ively maintained pancreas surgery data base at a single institution from August 2012 to April 2015 was undertaken . An enhanced recovery protocol was initiated in October 2014 , and patients were divided into groups according to pre protocol or post protocol implementation . Preoperative , intraoperative , and postoperative data were tabulated . Statistical analysis was performed with Student 's t-test and Fisher 's exact tests , as well as e quality of variances where appropriate , using SAS System software ( SAS Institute ) . RESULTS Three hundred and seventy-eight patients ( 181 men , mean age 54 years , BMI 28 kg/m(2 ) ) underwent elective pancreatic surgery during the study period , 297 patients pre protocol and 81 post protocol . There were no significant differences in preoperative or intraoperative characteristics . Mean postoperative length of stay was significantly lower in the Enhanced Recovery After Surgery group ( 7.4 vs 9.2 days ; p Hospital costs were similarly lower in the Enhanced Recovery After Surgery group ( $ 23,307.90 vs $ 27,387.80 ; p Readmission ( 29 % vs 32 % ) and pancreatic fistula ( 26 % vs 28 % ) rates were similar between groups . Delayed gastric emptying was lower in the Enhanced Recovery After Surgery group ( 26 % vs 13 % ; p = 0.03 ) . CONCLUSIONS Implementation of an enhanced recovery after pancreatic surgery protocol significantly decreased length of stay and hospital cost without increasing readmission or morbidity . Despite patient complexity and the potential need for individualization of care , enhanced recovery protocol s can be valuable and effective in high-risk patient population s , including pancreatic surgery patients",
"Objective : To determine the cost-effectiveness of enhanced recovery pathways ( ERPs ) versus conventional care for patients undergoing elective colorectal surgery . Background : ERPs for colorectal surgery are clinical ly effective , but their cost-effectiveness is unknown . Methods : A multi-institutional prospect i ve cohort cost-effectiveness analysis was performed . Adult patients undergoing elective colorectal resection at 2 university-affiliated institutions from October 2012 to October 2013 were enrolled . One center used an ERP , whereas the other did not . Postoperative outcomes were recorded up to 60 days . Total costs were reported in 2013 Canadian dollars . Effectiveness was measured using the SF-6D , a health utility measure vali date d for postoperative recovery . Uncertainty was expressed using bootstrapped estimates ( 10,000 repetitions ) . Results : A total of 180 patients were included ( conventional care : n = 95 ; ERP : n = 95 ) . There were no differences in patient characteristics except for a higher proportion of laparoscopy in the ERP group . Mean length of stay was shorter in the ERP group ( 6.5 vs 9.8 days ; P = 0.017 ) , but there were no differences in complications or readmissions . Patients in the ERP group returned to work quicker and had less caregiver burden . There was no difference in quality of life between the 2 groups . The cost of the ERP program was $ 153 per patient . Overall societal costs were lower in the ERP group ( mean difference = −2985 ; 95 % confidence interval , −5753 to −373 ) . The ERP had a greater than 99 % probability of cost-effectiveness . The results were insensitive to a range of assumptions and subgroups . Conclusions : Enhanced recovery is cost-effective compared with conventional perioperative management for elective colorectal resection",
"Fast‐track ( FT ) programmes are multimodal , evidence ‐based approaches to optimize patient outcome after surgery . The aim of this study was to evaluate the safety , clinical outcome and patients ' experience of a FT programme after pancreaticoduodenectomy ( PD ) in a high‐volume institution in Sweden"
] | 4116336e-06ff-11f0-808a-c43d1ab1c353 |
Epidemiological data have demonstrated an association between artificial sweetener use and weight gain . Evidence of a causal relationship linking artificial sweetener use to weight gain and other metabolic health effects is limited . However , recent animal studies provide intriguing information that supports an active metabolic role of artificial sweeteners . This systematic review examines the current literature on artificial sweetener consumption in children and its health effects . Eighteen studies were identified . Data from large , epidemiologic studies support the existence of an association between artificially-sweetened beverage consumption and weight gain in children . R and omized controlled trials in children are very limited , and do not clearly demonstrate either beneficial or adverse metabolic effects of artificial sweeteners . Presently , there is no strong clinical evidence for causality regarding artificial sweetener use and metabolic health effects , but it is important to examine possible contributions of these common food additives to the global rise in pediatric obesity and diabetes | [
"CONTEXT Caffeine acutely increases blood pressure , but the association between habitual consumption of caffeinated beverages and incident hypertension is uncertain . OBJECTIVE To examine the association between caffeine intake and incident hypertension in women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort study conducted in the Nurses ' Health Studies ( NHSs ) I and II of 155,594 US women free from physician-diagnosed hypertension followed up over 12 years ( 1990 - 1991 to 2002 - 2003 question naires ) . Caffeine intake and possible confounders were ascertained from regularly administered question naires . We also tested the associations with types of caffeinated beverages . MAIN OUTCOME MEASURE Incident physician-diagnosed hypertension . RESULTS During follow-up , 19,541 incident cases of physician-diagnosed hypertension were reported in NHS I and 13,536 in NHS II . In both cohorts , no linear association between caffeine consumption and risk of incident hypertension was observed after multivariate adjustment ( NHS I , P for trend = .29 ; NHS II , P for trend = .53 ) . Using categorical analysis , an inverse U-shaped association between caffeine consumption and incident hypertension was found . Compared with participants in the lowest quintile of caffeine consumption , those in the third quintile had a 13 % and 12 % increased risk of hypertension , respectively ( 95 % confidence interval in NHS I , 8%-18 % ; in NHS II , 6%-18 % ) . When study ing individual classes of caffeinated beverages , habitual coffee consumption was not associated with increased risk of hypertension . By contrast , consumption of cola beverages was associated with an increased risk of hypertension , independent of whether it was sugared or diet cola ( P for trend incident hypertension was found . Even though habitual coffee consumption was not associated with an increased risk of hypertension , consumption of sugared or diet cola was associated with it . Further research to eluci date the role of cola beverages in hypertension is warranted",
"BACKGROUND Increased intake of sugar-sweetened beverages and fruit juice has been associated with overweight in children . OBJECTIVE This study prospect ively assessed beverage consumption patterns and their relationship with weight status in a cohort of children born at different risk for obesity . METHODS AND PROCEDURES Participants were children born at low risk ( n = 27 ) or high risk ( n = 22 ) for obesity based on maternal prepregnancy BMI ( kg/m(2 ) ) . Daily beverage consumption was generated from 3-day food records from children aged 3 - 6 years and coded into seven beverage categories ( milk , fruit juice , fruit drinks , caloric and non-caloric soda , soft drinks including and excluding fruit juice ) . Child anthropometric measures were assessed yearly . RESULTS High-risk children consumed a greater percentage of daily calories from beverages at age 3 , more fruit juice at ages 3 and 4 , more soft drinks ( including fruit juice ) at ages 3 - 5 , and more soda at age 6 compared to low-risk children . Longitudinal analyses showed that a greater 3-year increase in soda intake was associated with an increased change in waist circumference , whereas a greater increase in milk intake was associated with a reduced change in waist circumference . There was no significant association between change in intake from any of the beverage categories and change in BMI z-score across analyses . DISCUSSION Children 's familial predisposition to obesity may differentially affect their beverage consumption patterns . Future research should examine the extent to which dietary factors may play a role in pediatric body fat deposition over time",
"OBJECTIVE The goal of this study was to determine the effect of artificial sweeteners on glucose , insulin , and glucagon-like peptide (GLP)-1 in humans . RESEARCH DESIGN AND METHODS For this study , 22 healthy volunteers ( mean age 18.5 ± 4.2 years ) underwent two 75-g oral glucose tolerance tests with frequent measurements of glucose , insulin , and GLP-1 for 180 min . Subjects drank 240 ml of diet soda or carbonated water , in r and omized order , 10 min prior to the glucose load . RESULTS Glucose excursions were similar after ingestion of carbonated water and diet soda . Serum insulin levels tended to be higher after diet soda , without statistical significance . GLP-1 peak and area under the curve ( AUC ) were significantly higher with diet soda ( AUC 24.0 ± 15.2 pmol/l per 180 min ) versus carbonated water ( AUC 16.2 ± 9.0 pmol/l per 180 min ; P = 0.003 ) . CONCLUSIONS Artificial sweeteners synergize with glucose to enhance GLP-1 release in humans . This increase in GLP-1 secretion may be mediated via stimulation of sweet-taste receptors on L-cells by artificial sweetener ",
"To examine whether artificial sweeteners aid in the control of long-term food intake and body weight , we gave free-living , normal-weight subjects 1150 g soda sweetened with aspartame ( APM ) or high-fructose corn syrup ( HFCS ) per day . Relative to when no soda was given , drinking APM-sweetened soda for 3 wk significantly reduced calorie intake of both females ( n = 9 ) and males ( n = 21 ) and decreased the body weight of males but not of females . However , drinking HFCS-sweetened soda for 3 wk significantly increased the calorie intake and body weight of both sexes . Ingesting either type of soda reduced intake of sugar from the diet without affecting intake of other nutrients . Drinking large volumes of APM-sweetened soda , in contrast to drinking HFCS-sweetened soda , reduces sugar intake and thus may facilitate the control of calorie intake and body weight",
"This study investigated whether the addition of the high-intensity sweetener aspartame to a multidisciplinary weight-control program would improve weight loss and long-term control of body weight . One hundred sixty-three obese women were r and omly assigned to consume or to abstain from aspartame-sweetened foods and beverages during 16 wk of a 19-wk weight-reduction program ( active weight loss ) , a 1-y maintenance program , and a 2-y follow-up period . Women in both treatment groups lost approximately 10 % of initial body weight ( 10 kg ) during active weight loss . Among women assigned to the aspartame-treatment group , aspartame intake was positively correlated with percentage weight loss during active weight loss ( r = 0.32 , P regain of initial body weight after 71 and 175 wk , respectively , whereas those in the no-aspartame group gained an average of 5.4 % ( 5.4 kg ) and 9.4 % ( 9.4 kg ) , respectively . The aspartame group lost significantly more weight overall ( P = 0.028 ) and regained significantly less weight during maintenance and follow-up ( P = 0.046 ) than did the no-aspartame group . Percentage weight losses at 71 and 175 wk were also positively correlated with exercise ( r = 0.32 , P eating control ( r = 0.37 , P aspartame may facilitate the long-term maintenance of reduced body weight",
"BACKGROUND Type 2 diabetes mellitus is an increasingly serious health problem among African American women . Consumption of sugar-sweetened drinks was associated with an increased risk of diabetes in 2 studies but not in a third ; however , to our knowledge , no data are available on African Americans regarding this issue . Our objective was to examine the association between consumption of sugar-sweetened beverages , weight gain , and incidence of type 2 diabetes mellitus in African American women . METHODS A prospect i ve follow-up study of 59,000 African American women has been in progress since 1995 . Participants reported on food and beverage consumption in 1995 and 2001 . Biennial follow-up question naires ascertained new diagnoses of type 2 diabetes . The present analyses included 43,960 women who gave complete dietary and weight information and were free from diabetes at baseline . We identified 2713 incident cases of type 2 diabetes mellitus during 338,884 person-years of follow-up . The main outcome measure was the incidence of type 2 diabetes mellitus . RESULTS The incidence of type 2 diabetes mellitus was higher with higher intake of both sugar-sweetened soft drinks and fruit drinks . After adjustment for confounding variables including other dietary factors , the incidence rate ratio for 2 or more soft drinks per day was 1.24 ( 95 % confidence interval , 1.06 - 1.45 ) . For fruit drinks , the comparable incidence rate ratio was 1.31 ( 95 % confidence interval , 1.13 - 1.52 ) . The association of diabetes with soft drink consumption was almost entirely mediated by body mass index , whereas the association with fruit drink consumption was independent of body mass index . CONCLUSIONS Regular consumption of sugar-sweetened soft drinks and fruit drinks is associated with an increased risk of type 2 diabetes mellitus in African American women . While there has been increasing public awareness of the adverse health effects of soft drinks , little attention has been given to fruit drinks , which are often marketed as a healthier alternative to soft drinks",
"OBJECTIVE —The aim of this study was to identify a dietary pattern associated with insulin resistance and investigate whether this pattern was prospect ively associated with type 2 diabetes . RESEARCH DESIGN AND METHODS — Analysis was based on 7,339 participants of the Whitehall II study . Dietary intake was measured using a 127-item food frequency question naire . We used the reduced rank regression method to determine dietary patterns using the homeostasis model assessment of insulin resistance as the intermediate or response variable . The association between the dietary pattern identified and incidence of type 2 diabetes was investigated using Cox proportional hazard regression models . RESULTS —We identified a dietary pattern characterized by high consumption of low-calorie/diet soft drinks , onions , sugar-sweetened beverages , burgers and sausages , crisps and other snacks , and white bread and low consumption of medium-/high-fiber breakfast cereals , jam , French dressing/vinaigrette , and wholemeal bread . Higher dietary pattern scores were associated with increased risk of type 2 diabetes ( hazard ratio for top quartile 2.95 [ 95 % CI 2.19–3.97 ] ; adjusted for age , sex , and energy misreporting ) . This relationship was attenuated after adjustment for ethnicity , employment grade , health behaviors ( smoking , alcohol use , and physical activity ) but remained significant after further adjustment for blood pressure and BMI ( 1.51 [ 1.10–2.09 ] ) . CONCLUSIONS —A dietary pattern associated with insulin resistance predicts type 2 diabetes risk after adjustment for a range of confounders . This study adds to the evidence that dietary patterns are an important risk factor for type 2 diabetes ",
"Television viewing ( TVV ) is considered a contributing factor to the development of childhood obesity yet it is unclear whether obesity results , in part , from increased energy intake during TVV . The objective of this study was to determine the effect of TVV on food intake ( FI ) of boys at a meal and its effect on caloric compensation at the test meal after a premeal glucose drink . On four separate mornings and in r and om order , boys received equally sweetened preloads containing Splenda sucralose or glucose [ 1.0 g/kg body weight ( BW ) ] in 250 mL of water 2 h after a st and ard breakfast . Food intake from a pizza meal was measured 30 min later with or without TVV . Both preload treatment ( p FI ( kcal ) . TVV increased lunchtime FI by an average of 228 kcal . Glucose suppressed FI in the no TVV condition compared with control , but the effect was not statistically significant during TVV . Body composition and subjective appetite scores were positively associated with FI at the test lunch . In conclusion , TVV while eating a meal contributes to increased energy intake by delaying normal mealtime satiation and reducing satiety signals from previously consumed foods",
"BACKGROUND The rising prevalence of obesity in children has been linked in part to the consumption of sugar-sweetened drinks . Our aim was to examine this relation . METHODS We enrolled 548 ethnically diverse schoolchildren ( age 11.7 years , SD 0.8 ) from public schools in four Massachusetts communities , and studied them prospect ively for 19 months from October , 1995 , to May , 1997 . We examined the association between baseline and change in consumption of sugar-sweetened drinks ( the independent variables ) , and difference in measures of obesity , with linear and logistic regression analyses adjusted for potentially confounding variables and clustering of results within schools . FINDINGS For each additional serving of sugar-sweetened drink consumed , both body mass index ( BMI ) ( mean 0.24 kg/m2 ; 95 % CI 0.10 - 0.39 ; p=0.03 ) and frequency of obesity ( odds ratio 1.60 ; 95 % CI 1.14 - 2.24 ; p=0.02 ) increased after adjustment for anthropometric , demographic , dietary , and lifestyle variables . Baseline consumption of sugar-sweetened drinks was also independently associated with change in BMI ( mean 0.18 kg/m2 for each daily serving ; 95 % CI 0.09 - 0.27 ; p=0.02 ) . INTERPRETATION Consumption of sugar-sweetened drinks is associated with obesity in children",
"In two experiments , 2 - 5-year-old children 's responsiveness to caloric density cues was examined . In a preloading protocol , consumption of fixed volumes of drinks ( 205 ml in Experiment 1 ; 150 ml in Experiment 2 ) , sweetened with sucrose , aspartame , aspartame plus low glucose maltodextrin , or a water control , was followed by ad lib consumption from among a variety of foods . Caloric drinks had about 90 kcal in Experiment 1 , 65 kcal in Experiment 2 . The delay interval between the preload and the ad lib consumption was 0 , 30 or 60 minutes . In Experiment 1 , 24 4- and 5-year-old children participated in only one delay interval , while in Experiment 2 , all 20 2- and 3-year-old children were seen in all conditions . Results revealed evidence of caloric compensation , but no evidence of preload x time delay interaction . In both experiments , aspartame also produced a significant suppression of intake relative to water , primarily due to the pattern at 30 min following the preload . Across conditions , the suppression following aspartame was usually significantly less than that produced by the caloric sweet drinks , providing evidence for postingestive effects . In Experiment 1 , suppression of intake was related to the children 's preferences for the foods , not to macronutrient content ; consumption of nonpreferred foods was most suppressed . Consumption of sweetened drinks as long as 1 hour prior to eating suppressed food intake , and this common feeding practice may also reduce dietary variety",
"OBJECTIVE To investigate the effect of 3-months ' daily administration of high doses of sucralose , a non-nutritive sweetener , on glycemic control in subjects with type 2 diabetes . DESIGN A multicenter , double-blind , placebo-controlled , r and omized study , consisting of a 6-week screening phase , a 13-week test phase , and a 4-week follow-up phase . SUBJECTS/ SETTING Subjects with type 2 diabetes ( age range 31 to 70 years ) entered the test phase of this study ; 128 subjects completed the study . The subjects were recruited from 5 medical centers across the United States and were , on average , obese . INTERVENTION Subjects were r and omly assigned to receive either placebo ( cellulose ) capsules ( n=69 ) or 667 mg encapsulated sucralose ( n=67 ) daily for the 13-week test phase . All subjects blindly received placebo capsules during the last 4 weeks of the screening phase and for the entire 4-week follow-up phase . MAIN OUTCOME MEASURES Glycated hemoglobin ( HbA1c ) , fasting plasma glucose , and fasting serum C-peptide were measured approximately every 2 weeks to evaluate blood glucose homeostasis . Data were analyzed by analysis of variance using repeated measures . RESULTS There were no significant differences between the sucralose and placebo groups in HbA1c , fasting plasma glucose , or fasting serum C-peptide changes from baseline . There were no clinical ly meaningful differences between the groups in any safety measure . CONCLUSIONS This study demonstrated that , similar to cellulose , sucralose consumption for 3 months at doses of 7.5 mg/kg/day , which is approximately three times the estimated maximum intake , had no effect on glucose homeostasis in individuals with type 2 diabetes . Additionally , this study showed that sucralose was as well-tolerated by the study subjects as was the placebo",
"OBJECTIVE . The role of sugar-sweetened beverages ( SSBs ) in promoting obesity is controversial . Observational data link SSB consumption with excessive weight gain ; however , r and omized , controlled trials are lacking and necessary to resolve the debate . We conducted a pilot study to examine the effect of decreasing SSB consumption on body weight . METHODS . We r and omly assigned 103 adolescents aged 13 to 18 years who regularly consumed SSBs to intervention and control groups . The intervention , 25 weeks in duration , relied largely on home deliveries of noncaloric beverages to displace SSBs and thereby decrease consumption . Change in SSB consumption was the main process measure , and change in body mass index ( BMI ) was the primary end point . RESULTS . All of the r and omly assigned subjects completed the study . Consumption of SSBs decreased by 82 % in the intervention group and did not change in the control group . Change in BMI , adjusted for gender and age , was 0.07 ± 0.14 kg/m2 ( mean ± SE ) for the intervention group and 0.21 ± 0.15 kg/m2 for the control group . The net difference , −0.14 ± 0.21 kg/m2 , was not significant overall . However , baseline BMI was a significant effect modifier . Among the subjects in the upper baseline- BMI tertile , BMI change differed significantly between the intervention ( −0.63 ± 0.23 kg/m2 ) and control ( + 0.12 ± 0.26 kg/m2 ) groups , a net effect of −0.75 ± 0.34 kg/m2 . The interaction between weight change and baseline BMI was not attributable to baseline consumption of SSBs . CONCLUSIONS . A simple environmental intervention almost completely eliminated SSB consumption in a diverse group of adolescents . The beneficial effect on body weight of reducing SSB consumption increased with increasing baseline body weight , offering additional support for American Academy of Pediatrics guidelines to limit SSB consumption",
"OBJECTIVES . The intent of this study was to evaluate whether small changes in diet and physical activity , as promoted by the America on the Move initiative , could prevent excessive weight gain in overweight children . METHODS . In this family-intervention study , the America on the Move small-changes approach for weight-gain prevention was evaluated in families with at least 1 child ( 7–14 years old ) who was overweight or at risk for overweight . These children were the primary target of the intervention , and parents were the secondary target . Families were r and omly assigned to either the America on the Move group ( n = 100 ) or the self-monitor – only group ( n = 92 ) . Families who were assigned to the America on the Move group were asked to make 2 small lifestyle changes : ( 1 ) to walk an additional 2000 steps per day above baseline as measured by pedometers and ( 2 ) to eliminate 420 kJ/day ( 100 kcal/day ) from their typical diet by replacing dietary sugar with a noncaloric sweetener . Families who were assigned to the self-monitor group were asked to use pedometers to record physical activity but were not asked to change their diet or physical activity level . RESULTS . During a 6-month period , both groups of children showed significant decreases in BMI for age . However , the America on the Move group compared with the self-monitor group had a significantly higher percentage of target children who maintained or reduced their BMI for age and , consistently , a significantly lower percentage who increased their BMI for age . There was no significant weight gain during the 6-month intervention in parents of either group . CONCLUSIONS . The small-changes approach advocated by America on the Move could be useful for addressing childhood obesity by preventing excess weight gain in families",
"The purpose of this investigation was twofold : ( 1 ) to examine the role of low- to moderate-intensity , short- duration physical activity on subjective appetite and ( 2 ) to identify the role of and associations between ventilation threshold ( VeT ) and energy intake at a pizza lunch 30 min after glucose and whey protein drinks in normal weight boys . In 14 boys ( age : 12.5+/-0.4 years ) subjective appetite was measured before and after a 12 min walking protocol design ed to determine physical fitness based on the VeT. On a separate occasion food intake ( FI ) and subjective appetite were measured in response to sweetened preloads of either a SPLENDA Sucralose control , glucose or whey protein made up to 250 ml with water , given in r and om order to each boy , 2h after a st and ardized breakfast . Subjective average appetite and prospect i ve food consumption scores increased after physical activity . VeT was positively associated with FI at a pizza lunch consumed 30 min after glucose and whey protein drinks . Glucose and whey protein reduced FI similarly at lunch compared with control . In conclusion , appetite is increased by low- to moderate-intensity , short- duration physical activity and FI following glucose and protein preloads is positively associated with fitness levels in boys",
"Objective The present study evaluated weight loss and compliance outcomes for overweight adolescents assigned to one of two dietary interventions differing in the type of snacks allowed . Methods The study was a 12-week , controlled clinical trial , among otherwise healthy but overweight ( body mass index ≥95th percentile ) 11-year-old to 15-year-old girls who were r and omly assigned to either a 1,500 kcal/day free-snack program or a 1,500 kcal/day restricted-snack program . All subjects were counseled to consume three servings of dairy products per day , and were provided with a 500 mg calcium supplement as well . Subjects in the free-snack group could choose any 150-calorie item as one of their two daily snacks , including regular soda if desired ; however , subjects in the restricted-snack group were limited to diet soda . Results Thirty-two adolescent girls completed the 12-week intervention . Both diets were equally effective in achieving a modest amount of weight loss , and were equally acceptable to the subjects . Significant decreases in weight , body mass index , anthropometric measures , total cholesterol and triglycerides were observed . Conclusions A 1,500 kcal/day diet allowing for a free snack of 150 calories was equally as effective as a more restricted snack policy in achieving a modest amount of weight loss among overweight 11-year-old to 15-year-old girls . In addition , results suggest that some soda may be included in a teen weight control diet , as long as caloric intake is maintained at recommended levels , and care is taken to achieve adequate intake of essential nutrients . Calcium intake among subjects was low at baseline , and , although it increased during the study ( due to supplementation ) , further efforts to increase consumption of naturally calcium-rich and calcium-fortified foods and beverages are needed",
"BACKGROUND A population of over 12,000 mature subjects participated in a longitudinal study ( 8 years ) of nutrition and health ( the Su . Vi . Max Study ) . In this context , a specific cross-sectional study was carried out in a r and omly selected sub population . AIM To identify anthropometric , nutritional and biochemical correlates of spontaneous use of ' light ' foods and drinks in a free-living population . DESIGN Men ( n = 2299 ) and women ( n = 1979 ) , 45 - 60 years , reported their food intakes over six non-consecutive days . Consumers of low-fat and low-sugar foods and drinks , and artificial sweeteners , were compared with non-consumers . RESULTS Users of low-sugar products were heavier than non-users ; female consumers of low-fat products , but not males , had higher body weight and BMI than non-consumers . Users of low-sugar products had higher triacylglycerols and glycaemia than non-users while biochemical parameters were not different in users and non-users of low-fat products . Use of low-sugar products led to increased diet density of a few micronutrients , including cholesterol . Low-fat product selection was associated with increased intake of most micronutrients , both in absolute value and in density . CONCLUSIONS In mature adults , selection of fat-reduced products was associated with improved quality of the diet , while anthropometric and biological parameters appeared less favourable in consumers of low-sugar products vs. non-consumers . The longitudinal follow-up of the cohort in future years will help determine cause- and -effect relationships among these parameters",
"OBJECTIVE The increase in consumption of sugar-added beverages over recent decades may be partly responsible for the obesity epidemic among U.S. adolescents . Our aim was to evaluate the relationship between BMI changes and intakes of sugar-added beverages , milk , fruit juices , and diet soda . RESEARCH METHODS AND PROCEDURES Our prospect i ve cohort study included > 10,000 boys and girls participating in the U.S. Growing Up Today Study . The participants were 9 to 14 years old in 1996 and completed question naires in 1996 , 1997 , and 1998 . We analyzed change in BMI ( kilograms per meter squared ) over two 1-year periods among children who completed annual food frequency question naires assessing typical past year intakes . We studied beverage intakes during the year corresponding to each BMI change , and in separate models , we studied 1-year changes in beverage intakes , adjusting for prior year intakes . Models included all beverages simultaneously ; further models adjusted for total energy intake . RESULTS Consumption of sugar-added beverages was associated with small BMI gains during the corresponding year ( boys : + 0.03 kg/m2 per daily serving , p = 0.04 ; girls : + 0.02 kg/m2 , p = 0.096 ) . In models not assuming a linear dose-response trend , girls who drank 1 serving/d of sugar-added beverages gained more weight ( + 0.068 , p = 0.02 ) than girls drinking none , as did girls drinking 2 servings/d ( + 0.09 , p = 0.06 ) or 3 + servings/d ( + 0.08 , p = 0.06 ) . Analyses of year-to-year change in beverage intakes provided generally similar findings ; boys who increased consumption of sugar-added beverages from the prior year experienced weight gain ( + 0.04 kg/m2 per additional daily serving , p = 0.01 ) . Children who increased intakes by 2 or more servings/d from the prior year gained weight ( boys : + 0.14 , p = 0.01 ; girls + 0.10 , p = 0.046 ) . Further adjusting our models for total energy intake substantially reduced the estimated effects , which were no longer significant . DISCUSSION Consumption of sugar-added beverages may contribute to weight gain among adolescents , probably due to their contribution to total energy intake , because adjustment for calories greatly attenuated the estimated associations",
"Given the potential use of a low-calorie sweetener during weight reduction , a toxicity study of chronic aspartame ingestion was conducted . Particular attention was given to possible long-term effects of aspartame on the fuel hormonal alterations characteristically caused by weight reduction . As a group mean age was 19.3 yr , body weight was 164.6 lb , and mean height was 65.4 in . Subjects were an average of 33 % in excess of ideal body weight . The aspartame dose was 2.7 g/day and was compared on a double-blind r and omized basis with a lactose placebo . Both material s were given in gelatin capsules . An average of 6.9 + /- 1.5 lb was lost by the aspartame group during the 13-wk study on a calculated 1,000-calorie diet . The placebo group lost 4.5 + /- 1.2 lb ( no significant difference between the two groups ) . After an overnight fast , reductions in glucose and immunoreactive insulin were seen in both groups , while rising trends in immunoreactive glucagon were observed . These changes are all characteristic of calorie restriction . In no instance was there a detectable effect of the ingested aspartame . No meaningful effect of weight reduction or aspartame was seen on plasma triglyceride and cholesterol , nor on any other parameter of hematologic , hepatic , or renal function that was measured . Similarly , side effects were equally distributed between asparatame and placebo",
"OBJECTIVE . The obesity epidemic in the United States continues to increase . Because obesity tends to track over time , the increase in overweight among young children is of significant concern . A number of eating patterns have been associated with overweight among preschool-aged children . Recently , 100 % fruit juice and sweetened fruit drinks have received considerable attention as potential sources of high-energy beverages that could be related to the prevalence of obesity among young children . Our aim was to evaluate the beverage intake among preschool children who participated in the National Health and Nutrition Examination Survey 1999–2002 and investigate associations between types and amounts of beverages consumed and weight status in preschool-aged children . METHODS . We performed a secondary analysis of the data from the National Health and Nutrition Examination Survey 1999–2002 , which is a continuous , cross-sectional survey of a nationally representative sample of the noninstitutionalized population of the United State . It included the collection of parent reported demographic descriptors , a 24-hour dietary recall , a measure of physical activity , and a st and ardized physical examination . The 24-hour dietary recall was obtained in person by a trained interviewer and reflected the foods and beverages that were consumed by the participant the previous day . The National Health and Nutrition Examination Survey food groups were classified on the basis of the US Department of Agriculture 's Food and Nutrient Data base for Dietary Studies . We review ed the main food descriptors used and classified all beverages listed . One hundred percent fruit juice was classified as only beverages that contained 100 % fruit juice , without sweetener . Fruit drinks included any sweetened fruit juice , fruit-flavored drink ( natural or artificial ) , or drink that contained fruit juice in part . Milk included any type of cow milk and then was subcategorized by percentage of milk fat . Any sweetened soft drink , caffeinated or uncaffeinated , was categorized as soda . Diet drinks included any fruit drink , tea , or soda that was sweetened by low-calorie sweetener . Several beverages were removed from the analysis because of low frequency of consumption among the sample . Water was not included in the analysis because it is not part of the US Department of Agriculture 's Food and Nutrient Data base categories . For the purpose s of this analysis , the beverages were converted and reported as ounces , rather than grams , as reported by the National Health and Nutrition Examination Survey , to make it more clinical ly relevant . The child 's BMI percentile for age and gender were calculated on the basis of Centers for Disease Control and Prevention criteria and used to identify children 's weight status as underweight ( , at risk for overweight ( 85 % to . Because of the small number of children in the underweight category , they were included in the normal-weight category for this analysis . Data were analyzed using SUDAAN 9.0.1 statistical software programs . SUDAAN allows for improved accuracy and validity of results by calculating test statistics for the stratified , multistage probability design of the National Health and Nutrition Examination Survey . Sample weights were applied to all analyses to account for unequal probability of selection from oversampling low-income children and black and Mexican American children . Descriptive and χ2 analyses and analysis of covariance , adjusting for age , gender , ethnicity , household income , energy intake , and physical activity , were conducted . RESULTS . All children who were aged 2 to 5 years were identified ( N = 1572 ) . Those with missing data were removed from additional analysis , result ing in a final sample of 1160 preschool children . Of the 1160 children analyzed , 579 ( 49.9 % ) were male . White children represented 35 % , black children represented 28.3 % , and Hispanic children represented 36.7 % of the sample . Twenty-four percent of the children were overweight or at risk for overweight ( BMI ≥85 % ) , and 10.7 % were overweight ( BMI ≥95 % ) . There were no statistically significant differences in BMI between boys and girls or among the ethnicities . Overweight children tended to be older ( mean age : 3.83 years ) compared with the normal-weight children ( mean age : 3.48 years ) . Eighty-three percent of children drank milk , 48 % drank 100 % fruit juice , 44 % drank fruit drink , and 39 % drank soda . Whole milk was consumed by 46.5 % of the children , and 3.1 % and 5.5 % of the children consumed skim milk and 1 % milk , respectively . Preschool children consumed a mean total beverage volume of 26.93 oz/day , which included 12.32 oz of milk , 4.70 oz of 100 % fruit juice , 4.98 oz of fruit drinks , and 3.25 oz of soda . Weight status of the child had no association with the amount of total beverages , milk , 100 % fruit juice , fruit drink , or soda consumed . There was no clinical ly significant association between the types of milk ( percentage of fat ) consumed and weight status . In analysis of covariance , daily total energy intake increased with increased consumption of milk , 100 % fruit juice , fruit drinks , and soda . However , there was not a statistically significant increase in BMI on the basis of quantity of milk , 100 % fruit juice , fruit drink , or soda consumed . CONCLUSIONS . On average , preschool children drank less milk than the 2005 Dietary Guidelines for Americans recommendation of 16 oz/day . Only 8.6 % drank low-fat or skim milk , as recommended for children who are older than 2 years . On average , preschool children drank total energy intake of the children but not with their BMI . Prospect ively study ing preschool children beyond 2 to 5 years of age , through their adiposity rebound ( ∼5.5–6 years ) to determine whether there is a trajectory increase in their BMI , may help to clarify the role of beverage consumption in total energy intake and weight status"
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Introduction : Meibomian Gl and Dysfunction ( MGD ) is a common , often overlooked , chronic condition affecting eyes for which various therapies are being evaluated . Considering the absence of a systematic review and meta- analysis , the present review was carried out . Methods : An appropriate search strategy eligibility criteria were framed and electronic data bases were scrutinized for appropriate literature . R and omized Controlled Trials ( RCTs ) enrolling patients diagnosed with MGD were included . Outcome measures were Tear Break Up Time ( TBUT ) , Schirmer ’s test , Meibomian Gl and ( MG ) secretion score , MG plugging score , OSDI and SPEED . Cochrane ’s tool was used to assess the risk of bias and Forest plot were generated either with fixed or r and om effects model , with St and ardized Mean Difference ( SMD ) . Results : TBUTs , Schirmer ’s test and OSDI scores for systemic antimicrobials with placebo were 1.58 [ 1.33 , 1.83 ] , 2.93 [ 0.78 , 5.09 ] and -3.58 [ -4.28 , -2.89 ] respectively . No quantitative synthesis was attempted for either mebiomian plugging or meibomian secretion scores and no significant changes were observed with any other outcome parameter . Conclusion : Only the systemic antimicrobials were found to improve the clinical features of meibomian gl and dysfunction . Varying effects of different therapeutic agents ( heat therapies , omega-3-fatty acids and castor oil ) were identified for MGD but the risk of bias pertaining to r and omization and allocation concealment was found to be associated with most of the current RCTs . More high quality evidence is required to confirm the findings of the present review | [
"PURPOSE To compare the effectiveness of a single LipiFlow ( ® ) treatment with combined lid warming and massage in patients with meibomian gl and dysfunction ( MGD ) . METHODS In this prospect i ve , r and omized , crossover , observer-masked clinical trial , subjects were r and omized to receive either a single 12-min LipiFlow-LipiFlow Thermal Pulsation ( LTP ) system treatment or to perform combined twice-daily lid warming and massage for 3 months . All subjects were examined before , and 1 and 3 months after initiation of treatments . Investigated parameters included subjective symptoms , lipid layer thickness , meibomian gl and assessment , tear break-up time , tear osmolarity , corneal and conjunctival staining , Schirmer test values , and tear meniscus height . RESULTS A total of 31 subjects completed the 3-month follow-up . At 1 and 3 months , patients in the LipiFlow treatment group had a significant reduction in Ocular Surface Disease Index ( OSDI ) scores compared with those in the lid-margin hygiene group . Both treatments produced a significant improvement in expressible meibomian gl and s compared to the baseline parameters , but no significant difference was noted between the two groups . The other investigated objective parameters did not show a significant difference . CONCLUSION Results of our study show that a single LipiFlow treatment is as least as effective as a 3-month , twice-daily lid margin hygiene regimen for MGD . However , the present study was observer-masked only , and therefore a placebo effect may have confounded any improvements in subjective symptoms and other parameters in both groups",
"Background Dysfunction of the meibomian gl and ( MG ) is among the most frequent causes of ophthalmological symptoms . The inflammation seen in meibomian gl and dysfunction ( MGD ) is part of its pathogenesis , and evidence of the antioxidant-inflammatory properties of omega-3 fatty acids suggests this to be an appropriate treatment for MGD . Objective We aim ed to assess the effectiveness of omega-3 fatty acids versus placebo , in improving the symptoms and signs of MGD . Methods We conducted a r and omized and double-mask trial of 3 months duration . We enrolled 61 patients who presented with symptomatic MGD and no tear instability ( defined as tear breakup time [ TBUT ] Participants were r and omly assigned to two homogeneous subgroups . For patients in group A , the study treatment included cleaning the lid margins with neutral baby shampoo and use of artificial tears without preservatives , plus a placebo oral agent . For patients in group B , the study treatment included cleaning the lid margins with neutral baby shampoo and use of artificial tears without preservatives , plus oral supplementation with omega-3 fatty acids . We performed the following tests : ( 1 ) TBUT ; ( 2 ) Schirmer I test ; ( 3 ) Ocular Surface Disease Index © ( OSDI © ; Allergan , Inc. , Irvine , CA , USA ) ; ( 4 ) MG expression ; ( 5 ) evaluation of lid margin inflammation ; and ( 6 ) interpalpebral and corneal dye staining . Results After 3 months of evaluation , the mean OSDI , TBUT , lid margin inflammation , and MG expression presented improvement from the baseline values , in group B ( P Schirmer test results were also improved and statistically significant ( P Oral omega-3 fatty acids , 1.5 grams per day , may be beneficial in the treatment of MGD , mainly by improving tear stability",
"IMPORTANCE The immunopathogenic mechanisms of dry eye disease ( DED ) , one of the most common ophthalmic conditions , is incompletely understood . Data from this prospect i ve , double-masked , r and omized trial demonstrate that targeting interleukin 1 ( IL-1 ) by topical application of an IL-1 antagonist is efficacious in significantly reducing DED-related patient symptoms and corneal epitheliopathy . OBJECTIVE To evaluate the safety and efficacy of treatment with the topical IL-1 receptor antagonist anakinra ( Kineret ; Amgen Inc ) in patients having DED associated with meibomian gl and dysfunction . DESIGN AND SETTING Prospect i ve phase 1/2 , r and omized , double-masked , vehicle-controlled clinical trial . PARTICIPANTS Seventy-five patients with refractory DED . INTERVENTIONS Participants were r and omized to receive treatment with topical anakinra , 2.5 % ( n = 30 ) , anakinra , 5 % ( n = 15 ) , or vehicle ( 1 % carboxymethylcellulose ) ( n = 30 ) 3 times daily for 12 weeks . MAIN OUTCOMES AND MEASURES Primary outcomes were corneal fluorescein staining ( CFS ) , complete bilateral CFS clearance , dry eye-related symptoms as measured by the Ocular Surface Disease Index , tear film breakup time , and meibomian gl and secretion quality . RESULTS Topical anakinra was well tolerated compared with vehicle , with no reports of serious adverse reactions attributable to the therapy . After 12 weeks of therapy , participants treated with anakinra , 2.5 % , achieved a 46 % reduction in their mean CFS score ( P = .12 compared with vehicle and P anakinra , 5 % , achieved a 17 % reduction in their mean CFS score ( P = .88 compared with vehicle and P = .33 compared with baseline ) ; and patients treated with vehicle achieved a 19 % reduction in their mean CFS score ( P = .11 ) . Complete bilateral CFS clearance was noted in 8 of 28 patients ( 29 % ) treated with anakinra , 2.5 % , vs in 2 of 29 patients ( 7 % ) treated with vehicle ( P = .03 ) . By week 12 , treatment with anakinra , 2.5 % , and treatment with anakinra , 5 % , led to significant reductions in symptoms of 30 % and 35 % , respectively ( P = .02 and P = .01 , respectively , compared with vehicle ) ; treatment with vehicle led to a 5 % reduction in symptoms . CONCLUSIONS AND RELEVANCE Treatment with topical anakinra , 2.5 % , for 12 weeks was safe and significantly reduced symptoms and corneal epitheliopathy in patients with DED . These data suggest that the use of an IL-1 antagonist may have a role as a novel therapeutic option for patients with DED . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00681109",
"PURPOSE This study aim ed to compare the efficacy of topical N-acetyl-cysteine ( NAC ) with a topical steroid-antibiotic combination , betamethasone-sulfacetamide sodium therapy in patients with meibomian gl and dysfunction ( MGD ) . METHODS Twenty patients with MGD were prospect ively r and omized and assigned into 2 groups . The patients were instructed to use either NAC 5 % or a topical steroid-antibiotic combination , betamethasone 0.1%-sulfacetamide sodium 10 % , topically 4 times a day for a month . All patients were instructed to apply lid hygiene once daily . RESULTS One month of topical therapy provided statistically significant improvements in fluorescein break-up time and Schirmer scores as compared with the initial study visit in both groups ( P≤0.001 ) . Significant improvements for the symptoms of ocular burning , itching , and intermittent filmy or blurred vision were noted in both groups at 1 month as compared with 1 day ( P0.05 ) . None of the patients developed an allergic reaction to the medications , and intraocular pressure measurements were within the normal limits in both groups . CONCLUSION When used in conjunction with eyelid hygiene , topical administration of NAC appears to be as effective as a topical steroid-antibiotic combination , betamethasone-sulfacetamide sodium therapy in patients with MGD",
"Purpose To evaluate the safety and effectiveness of the LipiFlow System compared to the iHeat Warm Compress ( WC ) for adults with meibomian gl and dysfunction ( MGD ) . Methods This was a non-significant risk , prospect i ve , open-label , r and omized , crossover multicenter clinical trial . One hundred thirty-nine subjects were r and omized between LipiFlow ( n=69 ) and WC control ( n=70 ) . Subjects in the LipiFlow group received a 12-minute LipiFlow treatment and were reexamined at 1 day , 2 weeks and 4 weeks . Control subjects received a 5-minute iHeat treatment with instructions to perform the same treatment daily for 2 weeks . At 2 weeks , they crossed over ( LipiFlow Crossover ) and received the LipiFlow treatment . Effectiveness parameters : meibomian gl and ( MG ) assessment , tear break-up time ( TBUT ) and dry eye symptoms . Safety parameters : adverse events , ocular health exam , ocular surface staining , intraocular pressure , visual acuity and discomfort . Results LipiFlow result ed in significant improvement ( P MG secretion at 2 and 4 weeks ( mean ± st and ard deviation at baseline = 6.3 ± 3.5 ; 2 weeks = 14.3 ± 8.7 ; 4 weeks = 16.7 ± 8.7 ) ; and TBUT at 2 and 4 weeks : ( at baseline = 5.5 ± 2.9 ; 2 weeks = 6.9 ± 5.0 ; 4 weeks = 7.4 ± 5.5 ) . There was no significant change in MG secretion or TBUT in the control group . LipiFlow result ed in a greater significant reduction in dry eye symptoms than the iHeat WC . The crossover group demonstrated similar significant improvement 2 weeks post-treatment with the LipiFlow . There was no significant difference between groups in the incidence of non-serious , device-related adverse events . Conclusion The LipiFlow System was significantly more effective than iHeat WC . These results support its safety and effectiveness in the treatment of MGD and dry eye symptoms",
"Purpose : To compare the efficacy of topical cyclosporine [ 0.05 % cyclosporine A ( CsA ) ] and preservative-free artificial tears in the treatment of meibomian gl and dysfunction ( MGD ) . Methods : A 3-month prospect i ve , r and omized , double-masked , parallel-group controlled trial enrolled 70 patients with symptomatic MGD and unstable tear film [ tear breakup time ( TBUT ) Patients were r and omized to topical CsA ( 0.05 % ; group A ) and 0.5 % carboxymethylcellulose ( control ; group B ) instilled twice daily for 3 months . Ocular Surface Disease Index ( OSDI ) , lid margin inflammation , meibomian gl and expression , conjunctival injection , corneal and interpalpebral dye staining , noninvasive tear breakup time ( NIBUT ) using the Tearscope Plus and invasive fluorescein tear breakup time ( FBUT ) , and Schirmer I test were performed . Results : At the 3-month evaluation , mean OSDI , NIBUT and FBUT , lid margin inflammation , meibomian gl and expressibility , and tarsal injection showed significant improvement from baseline in group A ( P OSDI improved significantly from baseline at 3 months ( P = 0.003 ) . TBUTs ( NIBUT and FBUT ) were significantly longer in group A at all visits , and the mean change of TBUTs from baseline was also significantly greater in group A at 3 months ( P < 0.001 ) . Conclusions : Topical CsA 0.05 % twice daily may be helpful in the treatment of MGD mainly by improving tear film stability",
"Background / aims To investigate the efficacy and safety of the MGDRx EyeBag ( The Eyebag Company , Halifax , UK ) eyelid warming device . Methods Twenty-five patients with confirmed meibomian gl and dysfunction (MGD)-related evaporative dry eye were enrolled into a r and omised , single masked , contralateral clinical trial . Test eyes received a heated device ; control eyes a non-heated device for 5 min twice a day for 2 weeks . Efficacy ( ocular symptomology , non-invasive break-up time , lipid layer thickness , osmolarity , meibomian gl and dropout and function ) and safety ( visual acuity , corneal topography , conjunctival hyperaemia and staining ) measurements were taken at baseline and follow-up . Subsequent patient device usage and ocular comfort was ascertained at 6 months . Results Differences between test and control eyes at baseline were not statistically significant for all measurements ( p>0.05 ) . After 2 weeks , statistically significant improvements occurred in all efficacy measurements in test eyes ( p Visual acuity and corneal topography were unaffected ( p>0.05 ) . All patients maintained higher ocular comfort after 6 months ( p MGDRx EyeBag is a safe and effective device for the treatment of MGD-related evaporative dry eye . Subjective benefit lasts at least 6 months , aided by occasional retreatment . Trial registration number NCT01870180",
"Abstract Aim The main treatment for meibomian gl and dysfunction ( MGD ) , a major cause of dry eye , is eyelid warming . Lack of compliance is the main reason for treatment failure . This has led to the development of eyelid-warming devices that are safe , effective and convenient . To obtain robust evidence demonstrating their efficacy , the authors conducted a 3-arm r and omized clinical study . Methods The authors conducted a 3-month assessor-blinded , r and omized , controlled trial of patients from the Singapore National Eye Centre experiencing at least one of eight dry eye symptoms ‘ often ’ or ‘ all the time ’ . Patients who wore contact lenses , had an active infection or known diagnosis of thyroid dysfunction and rheumatoid arthritis were excluded from the study . MGD participants were r and omly assigned to warm towel ( n = 25 ) , EyeGiene ® ( Eyedetec Medical Inc. , Danville , CA , USA ) ( n = 25 ) and Blephasteam ® ( Spectrum Thea Pharmaceuticals LTD , Macclesfield , UK ) ( n = 25 ) treatments . The primary efficacy and safety outcomes included the proportions of participants with improved symptoms and changes in best corrected visual acuity ( BCVA ) , respectively . Other outcomes included tear break up time ( TBUT ) , Schirmer test , corneal fluorescein dye staining and number of visibly occluded meibomian gl and ( MG ) orifices . Results The study population was 53.5 ± 11.1 years old and predominantly Chinese . For severity of symptom after 3 months of treatment , 78.3 % Blephasteam ® participants reported improvement compared to 45.5 % warm towel participants ( p = 0.023 ) . The corresponding proportions for improvement in the frequency of symptoms were 82.6 % and 50.0 % , respectively ( p = 0.020 ) . The proportions of improvement of symptoms in EyeGiene ® patients were not significantly different from warm towel intervention . At 1 month of treatment , the crude odds ratio of improvement of severity of irritation for Blephasteam ® compared to control was 3.0 ( 95 % CI 0.88–10.18 ) . However , the odds ratio adjusted by age was 5.67 ( 1.30–24.66 ) . The lid-warming treatments did not significantly change the TBUT , Schirmer test results or number of visibly occluded MGs in the study period . All treatment modalities did not worsen BCVA after 3 months . Conclusion Blephasteam ® is more effective than warm towel for MGD treatment , with warm towel and EyeGiene ® being comparable effective . Older age might predict for treatment efficacy . All studied therapies were safe for visual acuity ( VA ) for 3 months of treatment",
"PURPOSE To evaluate the effect of intense pulsed light ( IPL ) applied to the periocular area for meibomian gl and dysfunction ( MGD ) in a prospect i ve , double-masked , placebo-controlled , paired-eye study . METHODS Twenty-eight participants underwent IPL treatment , with homogeneously sequenced light pulses delivered to one eye and placebo treatment to the partner control eye at 1 , 15 , and 45 days following baseline ( BL ) evaluation . Lipid layer grade ( LLG ) , noninvasive tear break-up time ( NIBUT ) , tear evaporation rate ( TER ) , tear meniscus height ( TMH ) , and subjective symptom score using visual analogue scales ( VAS ) were compared with BL and control values at each visit . RESULTS Lipid layer grade improved significantly from BL to Day ( D ) 45 in the treated eye ( P . Noninvasive tear break-up time also improved significantly from BL to D45 in the treated ( P 0.001 ) . The tear evaporation rate was not different in the treated eye compared with the control eye at any visit . Tear meniscus height did not change from BL in either eye ( P > 0.05 ) . Visual analog scale symptom scores improved from BL in the treated ( P = 0.015 ) , but not the control eye ( P = 0.245 ) , with 86 % of participants noting reduced symptoms in the treated eye by D45 . CONCLUSIONS Intense pulsed light with multiple sculpted pulses shows therapeutic potential for MGD , improving tear film quality and reducing symptoms of dry eye . ( https://www.anzctr.org.au number , ACTRN12614000162617 . )",
"Purpose : To evaluate a novel thermodynamic treatment for obstructive meibomian gl and dysfunction ( MGD ) . Material s and Methods : Fourteen adult subjects ( 10 females , 4 males , mean age = 54.2 ± 9.6 yr ) were recruited in a multi-center , feasibility clinical trial in Durham and Cary , North Carolina and Boston , Massachusetts . Inclusion criteria included : previous diagnosis of moderate to severe dry eye ; dry eye symptoms for at least three months prior ; daily topical lubricant use ; and evidence of meibomian gl and ( MG ) obstruction in the central five gl and s of both eyes lower eyelids . Exclusion criteria included : history of recent acute or chronic ocular inflammation or infection and lid surface abnormalities affecting lid function . The treatment : the device heats the palpebral surface of upper and lower eyelids while simultaneously applying grade d pulsatile pressure to the outer eyelid for 12 min , thereby expressing the MGs during heating . One eye was r and omly selected to undergo additional manual heated expression with another treatment device . Results : The mean MG secretion score , tear break-up time , corneal staining score , number of MGs yielding liquid secretion and symptom scores all improved significantly from baseline to 1 week . This was maintained through the 3-month follow-up . There was no statistically significant difference in any outcome between the automated device treatment only and the additional heated manual expression . Conclusion : The combination of heat applied to the palpebral surface , while simultaneously expressing MGs during a single 12-minute treatment , was effective , in this feasibility study , in treating obstructive MG dysfunction and dry eye signs and symptoms for the 3-month study period",
"We assessed the efficacy of topical cyclosporin 0.05 % ophthalmic emulsion versus tobramycin 0.3%/dexamethasone 0.1 % in patients with posterior blepharitis . Posterior blepharitis improved significantly from the initial study visit with both cyclosporin treatment and tobramycin/dexamethasone . Cyclosporin provided greater improvements in Schirmer 's scores ( P tear break-up time ( P = 0.018 ) than tobramycin/dexamethasone after 12 weeks of treatment . Eyelid health also improved in both groups , but the mean improvement in meibomian gl and secretion quality was significantly greater with cyclosporin than with tobramycin/dexamethasone ( P = 0.015 ) . Moreover , a higher percentage of patients in the cyclosporin treatment group had improvements in symptoms of blurred vision , burning , and itching and more cyclosporin-treated patients experienced resolution of lid telangiectasia . The findings in this prospect i ve study suggest that posterior blepharitis can be more effectively treated with cyclosporin than with tobramycin/dexamethasone . These findings should be further evaluated in large-scale , controlled , clinical trials",
"Purpose To study the prevalence and associations of dry eye symptoms in adult Chinese . Methods The Beijing Eye Study is a population -based study in northern China , which included 4439 of 5324 subjects invited to participate with an age of 40 + years ( response rate : 83.4 % ) . For the present study , a r and om sample was taken consisting of 1957(44.1 % ) subjects ( 1112 women ; 56.9 % ) . Dry eye symptoms were evaluated with ( 1 ) an interviewer-assisted question naire ; ( 2 ) measurement of the tear-film break-up time ; ( 3 ) assessment of the fluorescein staining of the cornea ; ( 4 ) slit-lamp-based examination of a meibomian gl and dysfunction ; and ( 5 ) Schirmer 's test . Results Symptoms of a dry eye felt ‘ often ’ or ‘ at all times ’ were present in 411 subjects ( 21.0 % ) . In a multivariate analysis , dry eye symptoms were significantly associated with age ( P degree of nuclear cataract ( P=0.02 ) , and undercorrection of refractive error ( P=0.005 ; OR : 1.42 ; 95 % CI : 1.11 , 1.82 ) . All tests for dry eye did not vary significantly between the dry eye group and the normal group . Conclusions The dry eye symptoms as evaluated subjectively in a question naire occurred in about 21 % of the adult population in China , with associations to age , female gender , urban region , and undercorrection of a refractive error . Measurement of the tear-film break-up time , assessment of the corneal fluorescein staining , slit-lamp-based examination of a meibomian gl and dysfunction , and Schirmer 's test were not significantly associated with dry eye symptoms",
"PURPOSE To assess tear cytokine levels and clinical outcomes in moderate and severe meibomian gl and dysfunction ( MGD ) after 2 months of treatment with topical loteprednol etabonate and eyelid scrubs with warm compresses vs eyelid scrubs with warm compresses alone . DESIGN R and omized controlled trial . METHODS Patients with moderate and severe MGD were r and omized into 2 groups : topical loteprednol etabonate and eyelid scrubs with warm compresses ( Group I , 34 eyes ) or eyelid scrubs with warm compresses ( Group II , 36 eyes ) . We evaluated cytokine levels , tear film break-up time ( TBUT ) , corneal and conjunctival fluorescein staining , biomicroscopic examination of lid margins and meibomian gl and s , and the Ocular Surface Disease Index before initiating treatment and 1 month and 2 months after treatment . RESULTS There were significant decreases in the levels of interleukin (IL)-6 , IL-8 , and IL-1β in Group I , and IL-6 and IL-8 in Group II . Moreover , the observed decreases of these cytokines in Group I were attributed to a remarkable decrease between treatment and 1 month after treatment . In Group I , there were improvements in all of the clinical outcomes , with prominent improvement in TBUT , corneal and conjunctival fluorescein staining , and meibum quality after 1 month of treatment , compared with Group II . An improvement in meibomian gl and expressibility and MGD stage reduction were more remarkable in Group I. CONCLUSIONS Topical loteprednol etabonate and eyelid scrubs with warm compresses were tolerated and efficacious for the treatment of moderate and severe MGD . We suggest that such beneficial effects could manifest after 1 month",
"PURPOSE To assess clinical outcomes and tear cytokine levels in patients with moderate and severe meibomian gl and dysfunction ( MGD ) after treatment with oral minocycline and artificial tears versus artificial tears only . DESIGN Prospect i ve , r and omized clinical trial . METHODS Sixty eyes of 60 patients with stage 3 or 4 meibomian gl and dysfunction were enrolled . We evaluated the tear film break-up time , Schirmer test results , corneal and conjunctival fluorescein staining results , biomicroscopic examination results of lid margins and meibomian gl and s , and tear cytokine levels before and after 1 month and 2 months of oral minocycline and artificial tears ( group 1 ) or artificial tears only ( group 2 ) . Tear sample s were collected and analyzed using a BD Cytometric Bead Array ( BD Bioscience , San Jose , California , USA ) for detection of interleukin (IL)-1β , IL-6 , IL-7 , IL-8 , IL-12p70 , IL-17α , interferon-γ , tumor necrosis factor-α , and monocyte chemotactic protein-1 . The Wilcoxon signed-rank test , Mann-Whitney U test , generalized linear model , and linear mixed model were performed . RESULTS Patients in group 1 showed statistically significant improvement in all clinical signs and symptoms after 1 month and 2 months of treatment . Patients of group 1 showed more significant improvement compared with those in group 2 . Patients in group 1 also showed statistically significant reductions in IL-6 , IL-1β , IL-17α , tumor necrosis factor-α , and IL-12p70 after 2 months of treatment . CONCLUSIONS Oral minocycline can provide clinical benefits in treating moderate and severe meibomian gl and dysfunction by reducing inflammatory cytokine levels ",
"OBJECTIVE We developed low-concentration homogenized castor oil eye drops for the treatment of patients with noninflamed obstructive meibomian gl and dysfunction ( MGD ) , a major cause of lipid-deficiency dry eye , and assessed the safety , stability , and efficacy of the eye drops . DESIGN R and omized , double-masked , placebo-controlled crossover clinical trial . PARTICIPANTS Forty eyes of 20 patients with noninflamed MGD . METHODS After a preliminary study of eye drops containing castor oil , 2 % castor oil and 5 % polyoxyethylene castor oil ( emulsifier ) were mixed to formulate homogenized oil eye drops . The patients were assigned r and omly to receive oil eye drops or placebo six times daily for 2 periods of 2 weeks each . MAIN OUTCOME MEASURES At the end of each treatment period , we assessed symptoms , tear interference grade , tear evaporation , fluorescein and rose bengal scores , tear break-up time ( BUT ) , and meibomian gl and orifice obstruction . Safety and stability tests were also performed . RESULTS Symptom scores , tear interference grade , tear evaporation test results , rose bengal scores , tear BUT , and orifice obstruction scores after the oil eye drop period showed significant improvement compared with the results after the placebo period . No complications attributable to the eye drops were observed . The oil eye drops were stable when stored at 4 degrees C. CONCLUSIONS The results indicate that castor oil eye drops are effective and safe in the treatment of MGD . The possible mechanisms of this treatment are improvement of tear stability as a result of lipid spreading , ease of meibum expression , prevention of tear evaporation , and the lubricating effect of the oil eye drops",
"PURPOSE Blepharitis and meibomian gl and dysfunction ( MGD ) are common sources of complaints from patients . To evaluate the effect on ocular symptoms , ocular findings , and serum and meibomian gl and contents , patients with blepharitis and MGD were prospect ively evaluated to determine the effects of dietary supplementation with omega-3 fatty acids . METHODS In a prospect i ve r and omized placebo-controlled masked trial , patients with simple obstructive MGD and blepharitis , who had discontinued all topical medications and tetracyclines , received oral omega-3 dietary supplementation consisting of two 1000-mg capsules 3 times a day . Patients were examined every 3 months for 1 year with the Ocular Surface Disease Index ( OSDI ) objective clinical measures , including tear production and stability , ocular surface and meibomian gl and health , and biochemical plasma , red blood cell ( RBC ) , and meibum evaluation . Primary outcome measures were change in tear breakup time ( TBUT ) , meibum score , and overall OSDI score at 1 year . RESULTS At 1 year , the omega-3 group had a 36 % and 31 % reduction in their omega-6 to omega-3 fatty acid ratios in RBCs and plasma , respectively ( P = .3 ) , whereas the placebo group demonstrated no change . At 12 months , the omega-3 group had an improvement in TBUT , OSDI score , and meibum score . Changes in meibum content were observed in the omega-3 group ( P = .21 ) ; the level of meibum saturated fatty acids decreased . CONCLUSIONS This trial demonstrated a decrease in the RBC and plasma ratios of omega-6 to omega-3 in patients taking omega-3 dietary supplementation , as compared to controls , and improvements in their overall OSDI score , TBUT , and meibum score . This is the first demonstration of an induced change in the fatty acid saturation content in meibum as a result of dietary supplementation with omega-3 fatty acids",
"Objective : To investigate the efficacy of topical cyclosporine A 0.05 % ( tCsA ) ( Restasis ® , Allergan Pharmaceuticals ) in the treatment of meibomian gl and dysfunction ( posterior blepharitis ) . Methods : Thirty-three patients with symptomatic meibomian gl and dysfunction were r and omized in a prospect i ve study to either tCsA or placebo ( Refresh Plus ® preservative-free artificial tears ) , 2 times daily for 3 months . They were evaluated at baseline and at 1 , 2 , and 3 months for subjective symptoms and objective signs including meibomian gl and inclusion s , lid margin vascular injection , tarsal telangiectasis , fluorescein staining , tear breakup time , and Schirmer scores . Results : Twenty-six patients completed the study . All patients were tested for ocular symptoms , lid margin vascularity , tarsal telangiectasis , meibomian gl and inclusion s , tear breakup time , and fluorescein staining . At the 3-month visit , the tCsA group showed a greater improvement in ocular symptoms than the placebo group , but this difference was not statistically significant . At the 3-month visit , several objective examination findings were statistically significantly ( P included lid margin vascular injection , tarsal telangiectasis , and fluorescein staining . The most significant finding ( P = 0.001 ) was the greater decrease in the number of meibomian gl and inclusion s in the tCsA group compared with the placebo group . Conclusions : Topical CsA may be helpful in the treatment of meibomian gl and dysfunction ( posterior blepharitis ) . Topical CsA did not induce an improvement in the symptoms , but it did decrease the number of meibomian gl and inclusion s in patients with meibomian gl and dysfunction",
"PURPOSE The aim was to investigate the effect of low dose doxycycline ( 20 mg ) therapy in patients with chronic meibomian gl and dysfunction that were refractory to conventional therapy . METHODS The r and omized prospect i ve study enrolled 150 patients ( 300 eyes ) who have chronic meibomian gl and dysfunction and who did n't respond to lid hygiene and topical therapy for more than 2 months . All topical therapy was stopped for at least 2 weeks prior to beginning the study . After conducting the tear break up time test ( TBUT ) and Schirmer test , the authors r and omly divided the patients into three groups a high dose group ( doxycycline , 200 mg , twice a day ) , a low dose group ( doxycycline , 20 mg , twice a day ) and a control group ( placebo ) . After one month , the author repeated the TBUT and Schirmer tests , and analyzed the degree of symptomatic improvement . RESULTS Compared to the control group , both the high and low dose group showed statistically significant differences after treatment in TBUT , Schirmer test , the number of symptoms reported and the degree of improvement of subjective symptoms . However , there was no statistically significant difference between the high and low dose group after treatment in TBUT ( 9.42 + /- 2.87 sec , 9.54 + /- 1.58 sec , p=0.726 ) , Schirmer test ( 19.98 + /- 4.05 mm , 19.65 + /- 5.02 mm , p=0.624 ) , the number of symptoms reported ( 1.45 + /- 0.62 , 1.53 + /- 0.52 , p=0.304 ) , as well as the degree of improvement of subjective symptoms ( p=0.288 ) . The high dose group ( 18 patients , 39.13 % ) reported side effects more frequently than did the low dose group ( 8 patients , 17.39 % ) ( P=0.002 ) . CONCLUSIONS Low dose doxycycline ( 20 mg twice a day ) therapy was effective in patients with chronic meibomian gl and dysfunction that were refractory to conventional therapy",
"Background / aims To assess the efficacy and safety of oral azithromycin compared with oral doxycycline in patients with meibomian gl and dysfunction ( MGD ) who had failed to respond to prior conservative management . Methods 110 patients ( > 12 years old ) with MGD were r and omly assigned to receive either oral 5-day azithromycin ( 500 mg on day 1 and then 250 mg/day ) or 1-month doxycycline ( 200 mg/day ) . They also continued eyelid warming/cleaning and artificial tears . A score comprising five symptoms and seven signs ( primary outcome ) was recorded prior to treatment and at 1 week , and 1 and 2 months after treatment . Total score was the sum of both scores at each follow-up . Side effects were recorded and overall clinical improvement was categorised as excellent , good , fair or poor based on the percentage of change in the total score . Results Symptoms and signs improved significantly in both groups ( p=0.001 ) . While improvement of symptoms was not different between the groups , bulbar conjunctival redness ( p=0.004 ) and ocular surface staining ( p=0.01 ) were significantly better in the azithromycin group . The azithromycin group showed a significantly better overall clinical response ( p=0.01 ) . Mild gastrointestinal side effects were not significantly different between the groups except for the second visit , when the doxycycline group had significantly more side effects ( p=0.002 ) . Conclusions Although both oral azithromycin and doxycycline improved the symptoms of MGD , 5-day oral azithromycin is recommended for its better effect on improving the signs , better overall clinical response and shorter duration of treatment . Trial registration number NCT01783860",
"Introduction Azithromycin , a broad-spectrum antibiotic with potent anti-inflammatory activities , has the potential to effectively treat blepharitis , an inflammatory disease of the eyelid with abnormal eyelid flora as an etiologic determinant . The present study compared the efficacy of topical azithromycin ophthalmic solution 1 % ( AzaSite ® ; Inspire Pharmaceuticals , Inc , NC , USA ) combined with warm compresses ( azithromycin group ) to warm compresses alone ( compress group ) in patients with posterior blepharitis . Methods Twenty-one patients diagnosed with posterior blepharitis were r and omized in an open-label study to receive either azithromycin plus warm compresses ( 10 patients ) , or compresses alone ( 11 patients ) . All patients were instructed to apply compresses to each eye for 5–10 minutes twice daily for 14 days . Each eye in the azithromycin group also received azithromycin solution ( 1 drop ) twice daily for the first 2 days followed by once daily for the next 12 days . Patients were evaluated at study initiation ( visit 1 ) and at end of treatment ( visit 2 ) for the severity of five clinical signs : eyelid debris , eyelid redness , eyelid swelling , meibomian gl and ( MG ) plugging , and the quality of MG secretion . At visit 2 , patients also rated their degree of overall symptomatic relief . Results Twenty patients completed the study . At visit 2 , patients in the azithromycin group demonstrated significant improvements in MG plugging , MG secretions , and eyelid redness as compared with the compress group . In the azithromycin group , MG plugging resolved completely in three patients and MG secretion returned to normal in two patients ; no such results were seen in the compress group . Furthermore , a higher percentage of patients in the azithromycin group rated overall symptomatic relief as excellent or good . Visual acuity measurements and biomicroscopic evaluation revealed no ocular safety issues . Conclusion Azithromycin ophthalmic solution in combination with warm compresses provided a significantly greater clinical benefit than warm compresses alone in treating the signs and symptoms of posterior blepharitis",
"Purpose To compare the effects on ocular temperature , lipid layer grade , tear film stability , and tear meniscus height after a single application of two commercially available warm compresses in mild-to-moderate dry eye and to report participant treatment preference . Methods Forty-one subjects with mild-to-moderate dry eye symptoms were enrolled in a r and omized , paired-eye , investigator-masked trial . Heat was applied simultaneously to one eye ( r and omized ) with a portable eye mask ( EyeGiene ) and to the contralateral eye with a microwave-heated flaxseed eye bag ( MGDRx Eye Bag ) . Outer and inner eyelid temperatures , tear film lipid layer grade ( LLG ) , and noninvasive tear film breakup time ( NIBUT ) were measured at baseline and immediately after 10 minutes of device application . Results Outer and inner eyelid temperatures , LLG , and NIBUT did not differ before treatment between eyes assigned to eye mask and eye bag therapy . All measurements were significantly increased from baseline , after warming with both devices ( all p Outer and inner eyelid temperature changes were significantly greater with the eye bag than with the eye mask ( outer eyelid , + 3.5 ± 1.0 ° C vs. + 2.4 ± 0.8 ° C ; inner eyelid , + 3.5 ± 1.0 ° C vs. + 2.5 ± 0.9 ° C ; all p LLG and NIBUT improvement between treatments ( all p > 0.05 ) . A majority of subjects ( 78 % ) preferred the application of heat with the eye bag over the eye mask . Conclusions Both the EyeGiene mask and the MGDRx Eye Bag are convenient eyelid warming devices that result in clinical ly and statistically significant increases in NIBUT and LLG in patients with mild-to-moderate dry eye symptoms . The MGDRx Eye Bag is more effective in raising ocular temperature and is the preferred treatment method among subjects",
"PURPOSE To evaluate the efficacy of topical N-acetyl-cysteine ( NAC ) therapy in patients with meibomian gl and dysfunction ( MGD ) . METHODS Twenty patients with MGD were prospect ively r and omized and assigned into 2 groups . The patients were instructed to use either NAC 5 % or preservative-free artificial tear topically 4 times a day for a month . All patients were instructed to apply lid hygiene once daily . Preservative-free artificial tears treated group served as control . Paired sample Student 's t-tests were used to detect differences between the baseline and 1 month after treatment initiation in mean ocular symptoms , fluorescein break-up time ( FBUT ) values , and Schirmer scores in each group . Difference in mean ocular symptoms , Schirmer 's test scores , and FBUT values between the baseline and 1 month after treatment initiation were compared between the groups using Mann-Whitney U test . RESULTS One month of topical NAC therapy provided statistically significant improvements in FBUT and Schirmer scores as compared with the initial study visit . The average Schirmer increase rate was significantly better in the NAC group than in the control group . Significant improvements for the symptoms of ocular burning , foreign body sensation , and intermittent filmy or blurred vision were noted in both groups ; and only NAC-treated group showed improvement for the symptom of itching , at 1 month as compared with 1 day . NAC provided significantly better improvement in itching symptom when compared with controls . CONCLUSIONS Topical administration of NAC is thought to be effective and well tolerated in patients with MGD"
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We performed a systematic review of the available evidence on the relationship between the individual clinical , echocardiographic and laboratory characteristics of patients with atrial fibrillation ( AF ) and the risk of stroke . A systematic review was also performed of all published stroke risk stratification models , as well as the accuracy of their discriminative ability between risk strata . Third , we review ed the literature on cost-effectiveness analyses with oral anticoagulation in AF . From the systematic review on stroke risk factors , a prior stroke or transient ischemic attack ( 15/16 studies positive , risk ratio [ RR ] 2.86 ) , hypertension ( 11/20 studies positive , RR 2.27 ) , aging ( 9/13 studies positive , RR 1.46 per decade increase ) , structural heart disease ( 9/13 studies positive , RR 2.0 ) and diabetes ( 9/14 studies positive , RR 1.62 ) were found to be good independent predictors of stroke . Supportive evidence was found for sex ( 8/22 studies positive , RR 1.67 ) , vascular disease ( 6/17 studies positive , RR 2.61 ) and heart failure ( 7/18 studies positive , RR 1.85 ) . The various risk stratification schemes classified variable proportions as low , moderate and high risk , but the CHA(2)DS(2)-VASc score classified the smallest proportion of patients as ' low risk ' . Anticoagulation with vitamin K antagonists and dabigatran is cost-effective in patients at high risk of stroke , but not in patients without any other stroke risk factor beside AF . Continued efforts are warranted to improve the antithrombotic management of AF patients to identify , and challenge , risk factors and refine risk stratification models in order to realize an individualized tailored , risk factor-based approach | [
"Background — Recent studies have investigated alternatives to warfarin for stroke prophylaxis in patients with atrial fibrillation ( AF ) , but whether these alternatives are cost-effective is unknown . Methods and Results — On the basis of the results from R and omized Evaluation of Long Term Anticoagulation Therapy ( RE-LY ) and other trials , we developed a decision- analysis model to compare the cost and quality -adjusted survival of various antithrombotic therapies . We ran our Markov model in a hypothetical cohort of 70-year-old patients with AF using a cost-effectiveness threshold of $ 50 000/ quality -adjusted life-year . We estimated the cost of dabigatran as US $ 9 a day . For a patient with an average risk of major hemorrhage ( ≈3%/y ) , the most cost-effective therapy depended on stroke risk . For patients with the lowest stroke rate ( CHADS2 stroke score of 0 ) , only aspirin was cost-effective . For patients with a moderate stroke rate ( CHADS2 score of 1 or 2 ) , warfarin was cost-effective unless the risk of hemorrhage was high or quality of international normalized ratio control was poor ( time in the therapeutic range stroke risk ( CHADS2 stroke score ≥3 ) , dabigatran 150 mg ( twice daily ) was cost-effective unless international normalized ratio control was excellent ( time in the therapeutic range > 72.6 % ) . Neither dabigatran 110 mg nor dual therapy ( aspirin and clopidogrel ) was cost-effective . Conclusions — Dabigatran 150 mg ( twice daily ) was cost-effective in AF population s at high risk of hemorrhage or high risk of stroke unless international normalized ratio control with warfarin was excellent . Warfarin was cost-effective in moderate-risk AF population s unless international normalized ratio control was poor",
"Objectives To determine the incremental net health benefits of dabigatran etexilate 110 mg and 150 mg twice daily and warfarin in patients with non-valvular atrial fibrillation and to estimate the cost effectiveness of dabigatran in the United Kingdom . Design Quantitative benefit-harm and economic analyses using a discrete event simulation model to extrapolate the findings of the RE-LY ( R and omized Evaluation of Long-Term Anticoagulation Therapy ) study to a lifetime horizon . Setting UK National Health Service . Population Cohorts of 50 000 simulated patients at moderate to high risk of stroke with a mean baseline CHADS2 ( Congestive heart failure , Hypertension , Age≥75 years , Diabetes mellitus , previous Stroke/transient ischaemic attack ) score of 2.1 . Main outcome measures Quality adjusted life years ( QALYs ) gained and incremental cost per QALY of dabigatran compared with warfarin . Results Compared with warfarin , low dose and high dose dabigatran were associated with positive incremental net benefits of 0.094 ( 95 % central range −0.083 to 0.267 ) and 0.146 ( −0.029 to 0.322 ) QALYs . Positive incremental net benefits result ed for high dose dabigatran in 94 % of simulations versus warfarin and in 76 % of those versus low dose dabigatran . In the economic analysis , high dose dabigatran dominated the low dose , had an incremental cost effectiveness ratio of £ 23 082 ( € 26 700 ; $ 35 800 ) per QALY gained versus warfarin , and was more cost effective in patients with a baseline CHADS2 score of 3 or above . However , at centres that achieved good control of international normalised ratio , such as those in the UK , dabigatran 150 mg was not cost effective , at £ 42 386 per QALY gained . Conclusions This analysis supports regulatory decisions that dabigatran offers a positive benefit to harm ratio when compared with warfarin . However , no subgroup for which dabigatran 110 mg offered any clinical or economic advantage over 150 mg was identified . High dose dabigatran will be cost effective only for patients at increased risk of stroke or for whom international normalised ratio is likely to be less well controlled",
"OBJECTIVE This study was performed to characterize the risk of stroke in elderly patients with recurrent intermittent atrial fibrillation ( AF ) . BACKGROUND Although intermittent AF is common , relatively little is known about the attendant risk of stroke . METHODS A longitudinal cohort study was performed comparing 460 participants with intermittent AF with 1,552 with sustained AF treated with aspirin in the Stroke Prevention in Atrial Fibrillation studies and followed for a mean of two years . Independent risk factors for ischemic stroke were identified by multivariate analysis . RESULTS Patients with intermittent AF were , on average , younger ( 66 vs. 70 years , p women ( 37 % vs. 26 % p heart failure ( 11 % vs. 21 % , p annualized rate of ischemic stroke was similar for those with intermittent ( 3.2 % ) and sustained AF ( 3.3 % ) . In patients with intermittent AF , independent predictors of ischemic stroke were advancing age ( relative risk [ RR ] = 2.1 per decade , p hypertension ( RR = 3.4 , p = 0.003 ) and prior stroke ( RR = 4.1 , p = 0.01 ) . Of those with intermittent AF predicted to be high risk ( 24 % ) , the observed stroke rate was 7.8 % per year ( 95 % confidence interval 4.5 to 14 ) . CONCLUSIONS In this large cohort of AF patients given aspirin , those with intermittent AF had stroke rates similar to patients with sustained AF and similar stroke risk factors . Many elderly patients with recurrent intermittent AF have substantial rates of stroke and likely benefit from anticoagulation . High-risk patients with intermittent AF can be identified using the same clinical criteria that apply to patients with sustained AF",
"Oral dabigatran etexilate is indicated for the prevention of stroke and systemic embolism in patients with atrial fibrillation ( AF ) in whom anticoagulation is appropriate . Based on the RE-LY study we investigated the cost-effectiveness of Health Canada approved dabigatran etexilate dosing ( 150 mg bid for patients warfarin and \" real-world \" prescribing ( i.e. warfarin , aspirin , or no treatment in a cohort of warfarin-eligible patients ) from a Canadian payer perspective . A Markov model simulated AF patients at moderate to high risk of stroke while tracking clinical events [ primary and recurrent ischaemic strokes , systemic embolism , transient ischaemic attack , haemorrhage ( intracranial , extracranial , and minor ) , acute myocardial infa rct ion and death ] and result ing functional disability . Acute event costs and result ing long-term follow-up costs incurred by disabled stroke survivors were based on a Canadian prospect i ve study , published literature , and national statistics . Clinical events , summarized as events per 100 patient-years , quality -adjusted life years ( QALYs ) , total costs , and incremental cost effectiveness ratios ( ICER ) were calculated . Over a lifetime , dabigatran etexilate treated patients experienced fewer intracranial haemorrhages ( 0.49 dabigatran etexilate vs. 1.13 warfarin vs. 1.05 \" real-world \" prescribing ) and fewer ischaemic strokes ( 4.40 dabigatran etexilate vs. 4.66 warfarin vs. 5.16 \" real-world \" prescribing ) per 100 patient-years . The ICER of dabigatran etexilate was $ 10,440/QALY versus warfarin and $ 3,962/QALY versus \" real-world \" prescribing . This study demonstrates that dabigatran etexilate is a highly cost-effective alternative to current care for the prevention of stroke and systemic embolism among Canadian AF patients",
"Background and Purpose — Oral anticoagulants are effective at reducing stroke compared with aspirin in atrial fibrillation patients older than 75 years . Although the benefits of reduced stroke risk outweigh the risks of bleeding , the cost effectiveness of warfarin in this patient population has not yet been established . Methods — An economic evaluation was conducted alongside a r and omized , controlled trial ; 973 patients ≥75 years of age with atrial fibrillation were recruited from primary care and r and omly assigned to either take warfarin or aspirin . Follow-up was for a mean of 2.7 years . Costs of thrombotic and hemorrhagic events , anticoagulation clinic visits , and primary care utilization were determined . Clinical benefits were expressed in terms of a primary event avoided : fatal/nonfatal disabling stroke , intracranial hemorrhage , or systemic embolism . A cost-utility analysis was performed using quality -adjusted life years as the benefit measure . Results — Total costs over 4 years were lower in the warfarin group ( difference , −£165 ; 95 % CI , −£452–£89 ) , primarily driven by the difference in primary event costs . The primary event rate over 4 years was lower in the warfarin group ( 0.049 versus 0.099 ) , and the quality -adjusted life years score was higher ( difference , 0.02 ; 95 % CI , −0.07–0.11 ) . With lower costs and a higher quality -adjusted life years score , warfarin is the dominant treatment , but the differences in both costs and effects are small . Conclusions — Warfarin is cost-effective compared with aspirin in atrial fibrillation patients age ≥75 years . These data support the anticoagulant therapy option in this high-risk patient population . However , the small differences in costs and effects indicate the importance of exploring patient preferences",
"BACKGROUND AND PURPOSE Nonvalvular atrial fibrillation ( AF ) is a strong , independent risk factor for stroke , but the absolute rate of stroke varies widely among AF patients , importantly influencing the potential benefit of antithrombotic prophylaxis . We explore factors associated with ischemic stroke in AF patients taking aspirin . METHODS We performed multivariate logistic regression analysis of 2012 participants given aspirin alone or in combination with low , inefficacious doses of warfarin in the Stroke Prevention in Atrial Fibrillation I-III trials followed for a mean of 2.0 years , during which 130 ischemic strokes were observed . RESULTS Age ( relative risk [RR]=1.8 per decade , P hypertension ( RR=2.0 , P systolic blood pressure > 160 mm Hg ( RR=2.3 , P prior stroke or transient ischemic attack ( RR=2.9 , P stroke risk . Regular consumption of > /=14 alcohol-containing drinks per week was associated with reduced stroke risk ( adjusted RR=0.4 , P=0.04 ) . Among SPAF III participants , estrogen hormone replacement therapy was associated with a higher risk of ischemic stroke ( adjusted RR=3.2 , P=0.007 ) . With the use of these variables , a risk stratification scheme for primary prevention separated participants into those with high ( 7.1%/y , 22 % of the cohort ) , moderate ( 2.6%/y , 37 % of the cohort ) , and low ( 0.9%/y , 41 % of the cohort ) rates of stroke . Ischemic strokes in low-risk participants were less often disabling ( P Patients with AF who have high and low rates of stroke during treatment with aspirin can be identified . However , validation of our risk stratification scheme is necessary before it can be applied with confidence to clinical management . Postmenopausal estrogen replacement therapy and moderate alcohol consumption may additionally modify the risk of stroke in AF , but these findings require confirmation",
"Background and Purpose — Stroke risk increases with age in patients who have nonvalvular atrial fibrillation . It is uncertain whether the efficacy of stroke prevention therapies in atrial fibrillation changes as patients age . The objective of this study was to determine the effect of age on the relative efficacy of oral anticoagulants ( OAC ) and antiplatelet ( AP ) therapy ( including acetylsalicylic acid and triflusal ) on ischemic stroke , serious bleeding , and vascular events in patients with atrial fibrillation . Methods — This is an analysis of the Atrial Fibrillation Investigators data base , which contains patient level- data from r and omized trials of stroke prevention in atrial fibrillation . We used Cox regression models with age as a continuous variable that controlled for sex , year of r and omization , and history of cerebrovascular disease , diabetes , hypertension , and congestive heart failure . Outcomes included ischemic stroke , serious bleeding ( intracranial hemorrhage or systemic bleeding requiring hospitalization , transfusion , or surgery ) , and cardiovascular events ( ischemic stroke , myocardial infa rct ion , systemic embolism , or vascular death ) . Results — The analysis included 8932 patients and 17 685 years of observation from 12 trials . Patient age increased risk of ischemic stroke ( adjusted hazard ratio per decade increase 1.45 ; 95 % CI , 1.26 to 1.66 ) , serious bleeding ( 1.61 ; 1.47 to 1.77 ) , and cardiovascular events ( 1.43 ; 1.33 to 1.53 ) . Compared with placebo , OAC and AP significantly reduced the risk of ischemic stroke ( OAC , 0.36 ; 0.29 to 0.45 ; AP , 0.81 ; 0.72 to 0.90 ) and cardiovascular outcomes ( OAC , 0.59 ; 0.52 to 0.66 ; AP , 0.81 ; 0.75 to 0.88 ) , whereas OAC increased risk of serious bleeding ( 1.56 ; 1.03 to 2.37 ) . The relative benefit of OAC versus placebo or AP did not vary by patient age for any outcome . Compared with placebo , the relative benefit of AP for preventing ischemic stroke decreased significantly as patients aged ( P=0.01 ) . Conclusions — As patients with atrial fibrillation age , the relative efficacy of AP to prevent ischemic stroke appears to decrease , whereas it does not change for OAC . Because stroke risk increases with age , the absolute benefit of OAC increases as patients get older",
"ACCF : American College of Cardiology Foundation ACCP : American College of Chest Physicians ACS : acute coronary syndrome ACT : Atrial arrhythmia Conversion Trial ADONIS : American – Australian – African trial with DronedarONe In atrial fibrillation or flutter for the maintenance of Sinus rhythm AF : atrial fibrillation AHA : American Heart Association AND ROMEDA : ANtiarrhythmic trial with DROnedarone in Moderate-to-severe congestive heart failure Evaluating morbidity DecreAse APHRS : Asia Pacific Heart Rhythm Society aPTT : activated partial thromboplastin time ARB : angiotensin-receptor blocker ARISTOTLE : Apixaban for Reduction In STroke and Other ThromboemboLic Events in atrial fibrillation ATHENA : A placebo-controlled , double-blind , parallel arm Trial to assess the efficacy of dronedarone 400 mg b.i.d . for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter ATRIA : AnTicoagulation and Risk factors In Atrial fibrillation AVERROES : Apixaban VErsus acetylsalicylic acid ( ASA ) to Reduce the Rate Of Embolic Stroke in atrial fibrillation patients who have failed or are unsuitable for vitamin K antagonist treatment AVRO : A prospect i ve , r and omized , double-blind , Active-controlled , superiority study of Vernakalant vs. amiodarone in Recent Onset atrial fibrillation b.i.d : bis in die ( twice daily ) b.p.m . : beats per minute CABANA : Catheter ABlation vs . ANtiarrhythmic drug therapy for Atrial fibrillation CABG : coronary artery bypass graft CAP : Continued Access to Protect AF CHA2DS2-VASc : Congestive heart failure or left ventricular dysfunction Hypertension , Age ≥75 ( doubled ) , Diabetes , Stroke (doubled)-Vascular disease , Age 65–74 , Sex category ( female ) CHADS2 : Congestive heart failure , Hypertension , Age ≥75 , Diabetes , Stroke ( doubled ) CI : confidence interval CRAFT : Controlled R and omized Atrial Fibrillation Trial CrCl : creatinine clearance DAFNE : Dronedarone Atrial FibrillatioN study after Electrical cardioversion DIONYSOS : R and omized Double blind trIal to evaluate efficacy and safety of drOnedarone ( 400 mg b.i.d . ) vs . amiodaroNe ( 600 mg q.d . for 28 daYS , then 200 mg qd thereafter ) for at least 6 mOnths for the maintenance of Sinus rhythm in patients with atrial fibrillation EAST : Early treatment of Atrial fibrillation for Stroke prevention Trial EHRA : European Heart Rhythm Association ECG : electrocardiogram EMA : European Medicines Agency ERATO : Efficacy and safety of dRonedArone for The cOntrol of ventricular rate during atrial fibrillation EURIDIS : EURopean trial In atrial fibrillation or flutter patients receiving Dronedarone for the maIntenance of Sinus rhythm FAST : atrial Fibrillation catheter Ablation vs . Surgical ablation Treatment FDA : Food and Drug Administration Flec-SL : Flecainide Short-Long trial HAS-BLED : Hypertension , Abnormal renal/liver function , Stroke , Bleeding history or predisposition , Labile INR , Elderly , Drugs/alcohol concomitantly HF-PEF : heart failure with preserved ejection fraction HF-REF : heart failure with reduced ejection fraction HR : hazard ratio HRS : Heart Rhythm Society ICH : intracranial haemorrhage INR : international normalized ratio i.v . : intravenous J-RHYTHM : Japanese RHYTHM management trial for atrial fibrillation LAA : left atrial appendage LoE : level of evidence LVEF : left ventricular ejection fraction MANTRA-PAF : Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Paroxysmal Atrial Fibrillation NICE : National Institute for Health and Clinical Excellence NOAC : novel oral anticoagulant NSAID : non-steroidal anti-inflammatory drug NYHA : New York Heart Association OAC : oral anticoagulant or oral anticoagulation o.d . : omni die ( every day ) PALLAS : Permanent Atrial fibriLLAtion outcome Study using dronedarone on top of st and ard therapy PCI : percutaneous coronary intervention PREVAIL : Prospect i ve R and omized EVAluation of the LAA closure device In patients with atrial fibrillation v s. Long-term warfarin therapy PROTECT AF : WATCHMAN LAA system for embolic PROTECTion in patients with Atrial Fibrillation PT : prothrombin time RAAFT : Radio frequency Ablation Atrial Fibrillation Trial RE-LY : R and omized Evaluation of Long-term anticoagulant therapY with dabigatran etexilate ROCKET-AF : Rivaroxaban Once daily oral direct factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in atrial fibrillation RRR : relative risk reduction TE : thromboembolism TIA : transient ischaemic attack t.i.d . : ter in die ( three times daily ) TOE : transoesophageal echocardiogram TTR : time in therapeutic range VKA : vitamin K antagonist Guidelines summarize and evaluate all currently available evidence on a particular issue with the aim of assisting physicians in selecting the best management strategy for an individual patient suffering from a given condition , taking into account the impact on",
"Background —Previous studies provide conflicting results about whether women are at higher risk than men for thromboembolism in the setting of atrial fibrillation ( AF ) . We examined data from a large contemporary cohort of AF patients to address this question . Methods and Results —We prospect ively studied 13 559 adults with AF and recorded data on patients ’ clinical characteristics and the occurrence of incident hospitalizations for ischemic stroke , peripheral embolism , and major hemorrhagic events through search ing vali date d computerized data bases and medical record review . We compared event rates by patient sex using multivariable log-linear regression , adjusting for clinical risk factors for stroke , and stratifying by warfarin use . We identified 394 ischemic stroke and peripheral embolic events during 15 494 person-years of follow-up off warfarin . After multivariable analysis , women had higher annual rates of thromboembolism off warfarin than did men ( 3.5 % versus 1.8 % ; adjusted rate ratio [ RR ] , 1.6 ; 95 % CI , 1.3 to 1.9 ) . There was no significant difference by sex in 30-day mortality after thromboembolism ( 23 % for both ) . Warfarin use was associated with significantly lower adjusted thromboembolism rates for both women and men ( RR , 0.4 ; 95 % CI , 0.3 to 0.5 ; and RR , 0.6 ; 95 % CI , 0.5 to 0.8 , respectively ) , with similar annual rates of major hemorrhage ( 1.0 % and 1.1 % , respectively ) . Conclusions —Women are at higher risk than men for AF-related thromboembolism off warfarin . Warfarin therapy appears be as effective in women , if not more so , than in men , with similar rates of major hemorrhage . Female sex is an independent risk factor for thromboembolism and should influence the decision to use anticoagulant therapy in persons with AF",
"Objective To compare the predictive power of the main existing and recently proposed schemes for stratification of risk of stroke in older patients with atrial fibrillation . Design Comparative cohort study of eight risk stratification scores . Setting Trial of thromboprophylaxis in stroke , the Birmingham Atrial Fibrillation in the Aged ( BAFTA ) trial . Participants 665 patients aged 75 or over with atrial fibrillation based in the community who were r and omised to the BAFTA trial and were not taking warfarin throughout or for part of the study period . Main outcome measures Events rates of stroke and thromboembolism . Results 54 ( 8 % ) patients had an ischaemic stroke , four ( 0.6 % ) had a systemic embolism , and 13 ( 2 % ) had a transient ischaemic attack . The distribution of patients classified into the three risk categories ( low , moderate , high ) was similar across three of the risk stratification scores ( revised CHADS2 , NICE , ACC/AHA/ESC ) , with most patients categorised as high risk ( 65 - 69 % , n=460 - 457 ) and the remaining classified as moderate risk . The original CHADS2 ( Congestive heart failure , Hypertension , Age ≥75 years , Diabetes , previous Stroke ) score identified the lowest number as high risk ( 27 % , n=180 ) . The incremental risk scores of CHADS2 , Rietbrock modified CHADS2 , and CHA2DS2-VASc ( CHA2DS2-Vascular disease , Age 65 - 74 years , Sex ) failed to show an increase in risk at the upper range of scores . The predictive accuracy was similar across the tested schemes with C statistic ranging from 0.55 ( original CHADS2 ) to 0.62 ( Rietbrock modified CHADS2 ) , with all except the original CHADS2 predicting better than chance . Bootstrapped paired comparisons provided no evidence of significant differences between the discriminatory ability of the schemes . Conclusions Based on this single trial population , current risk stratification schemes in older people with atrial fibrillation have only limited ability to predict the risk of stroke . Given the systematic undertreatment of older people with anticoagulation , and the relative safety of warfarin versus aspirin in those aged over 70 , there could be a pragmatic rationale for classifying all patients over 75 as “ high risk ” until better tools are available",
"Background Antithrombotic management in atrial fibrillation ( AF ) is currently based on clinical characteristics , despite evidence of potential fine-tuning with transoesophageal echocardiography ( TEE ) . This open , r and omised , multicentre study addresses the hypothesis that a comprehensive strategy of TEE-based aspirin treatment in AF patients is feasible and safe . Methods Between 2005 and 2009 , ten large hospitals in the Netherl and s enrolled AF patients with a moderate risk of stroke . Patients without thrombogenic TEE characteristics were r and omised to aspirin or vitamin K antagonists ( VKA ) . The primary objective is to show that TEE-based aspirin treatment is safe compared with VKA therapy . The secondary objective tests feasibility of TEE as a tool to detect echocardiographic features of high stroke risk . This report compares r and omised to non-r and omised patients and describes the feasibility of a TEE-based approach . Results In total , 310 patients were included . Sixty-nine patients were not r and omised because of non-visualisation ( n = 6 ) or TEE risk factors ( n = 63 ) . Compared with non-r and omised patients , r and omised patients ( n = 241 ) were younger ( 65 ± 11 vs. 69 ± 9 years , p = 0.004 ) , had less coronary artery disease ( 9 vs. 20 % , p = 0.018 ) , previous TIA ( 1.7 vs. 7.2 % , p = 0.029 ) , AF during TEE ( 25 vs. 54 % , p mitral incompetence ( 55 vs. 70 % , p = 0.038 ) , VKA use ( 69 vs. 82 % , p = 0.032 ) , had a lower mean CHADS2 score ( 1.2 ± 0.6 vs. 1.6 ± 1.0 , p = 0.004 ) , and left ventricular ejection fraction ( 59 ± 8 vs. 56 ± 8 % , p = 0.016 ) . Conclusions This study shows that a TEE-based approach for fine-tuning stroke risk in AF patients with a moderate risk for stroke is feasible . Follow-up data will address the safety of this TEE-based approach",
"In a prospect i ve study of 312 older patients with chronic atrial fibrillation , at 36-month follow-up evaluation , new thromboembolic stroke developed in 162 of 312 patients ( 52 % ) . Significant independent risk factors for new thromboembolic stroke were prior stroke ( risk ratio = 1.6 ) , rheumatic mitral stenosis ( risk ratio = 2.0 ) , left ventricular ( LV ) hypertrophy ( risk ratio = 2.8 ) , abnormal LV ejection fraction ( risk ratio = 1.8 ) , serum total cholesterol ( risk ratio = 1.005 ) , and serum high-density lipoprotein cholesterol ( risk ratio = 0.96 )",
"BACKGROUND The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment . Rivaroxaban , an oral factor Xa inhibitor , may provide more consistent and predictable anticoagulation than warfarin . METHODS In a double-blind trial , we r and omly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke to receive either rivaroxaban ( at a daily dose of 20 mg ) or dose-adjusted warfarin . The per- protocol , as-treated primary analysis was design ed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism . RESULTS In the primary analysis , the primary end point occurred in 188 patients in the rivaroxaban group ( 1.7 % per year ) and in 241 in the warfarin group ( 2.2 % per year ) ( hazard ratio in the rivaroxaban group , 0.79 ; 95 % confidence interval [ CI ] , 0.66 to 0.96 ; P rivaroxaban group ( 2.1 % per year ) and in 306 patients in the warfarin group ( 2.4 % per year ) ( hazard ratio , 0.88 ; 95 % CI , 0.74 to 1.03 ; P Major and nonmajor clinical ly relevant bleeding occurred in 1475 patients in the rivaroxaban group ( 14.9 % per year ) and in 1449 in the warfarin group ( 14.5 % per year ) ( hazard ratio , 1.03 ; 95 % CI , 0.96 to 1.11 ; P=0.44 ) , with significant reductions in intracranial hemorrhage ( 0.5 % vs. 0.7 % , P=0.02 ) and fatal bleeding ( 0.2 % vs. 0.5 % , P=0.003 ) in the rivaroxaban group . CONCLUSIONS In patients with atrial fibrillation , rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism . There was no significant between-group difference in the risk of major bleeding , although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group . ( Funded by Johnson & Johnson and Bayer ; ROCKET AF Clinical Trials.gov number , NCT00403767 . )",
"BACKGROUND A prothrombotic or hypercoagulable state in atrial fibrillation may contribute to stroke and thromboembolism . Results of longitudinal population -based studies in elderly people with atrial fibrillation are not yet available . METHODS In the Rotterdam Study , a population -based prospect i ve cohort study , 162 participants with atrial fibrillation at baseline , aged 55 years and over , were matched for age and gender with 324 people in sinus rhythm . Associations were examined between three coagulation factors and the risk of total and cardiac mortality and stroke . Hazard rate ratios were calculated with 95 % confidence intervals using Cox 's proportional hazards model , adjusted for potential confounders . RESULTS Plasma von Willebr and factor was , age- and gender-adjusted , associated with cardiac mortality in the total population ( relative risk 1.16 ; 1.06 - 1.27 , per 10 IU dL(-1 ) increase ) , but statistical significance was lost after additional adjustments . A strong association ( 1.27 ; 1.08 - 1.50 , per 5-unit increase ) was found between soluble P-selectin ( sP-sel ) and cardiac mortality in atrial fibrillation patients but not in participants in sinus rhythm . Furthermore , the expected association between fibrinogen and cardiac mortality was observed only in those in sinus rhythm ( 2.60 ; 1.69 - 4.01 , per unit increase ) , and not in atrial fibrillation . No associations were found between coagulation factors and stroke . CONCLUSIONS In this population -based study , plasma levels of sP-sel predicted clinical adverse outcomes in atrial fibrillation , suggesting a role of platelets in the prothrombotic state associated with atrial fibrillation . Fibrinogen was a risk factor of cardiac and all-cause mortality in sinus rhythm , but not in atrial fibrillation",
"Abstract Chronic atrial fibrillation ( AF ) in the presence or absence of rheumatic valvular heart disease is associated with an increased incidence of stroke . 1,2 We reported in a prospect i ve study that at 27-month follow-up , echocardiographic left ventricular ( LV ) hypertrophy in elderly patients with systolic or diastolic hypertension was associated with an increased incidence of new atherothrombotic brain infa rct ion . 3 We also demonstrated in a prospect i ve study that at 3-year follow-up , risk factors for atherothrombotic brain infa rct ion were cigarette smoking , systolic or diastolic hypertension and diabetes mellitus in elderly men and systolic or diastolic hypertension , diabetes mellitus and obesity in elderly women . 4 This report correlates in elderly patients with chronic AF the prevalence of thromboembolic ( TE ) stroke with the presence or absence of rheumatic mitral stenosis , mitral anular calcium , valvular aortic stenosis , systolic or diastolic hypertension , prior myocardial infa rct ion , left atrial enlargement and LV hypertrophy",
"BACKGROUND AND PURPOSE The risk of major vascular events after an initial episode of cerebral ischemia in patients with nonrheumatic atrial fibrillation ( NRAF ) varies from 2 % to 15 % in the first year and is approximately 5 % yearly thereafter . Few studies have reported on risk factors that can be used to identify high-risk subgroups within this patient population . METHODS We studied the predictive value of several easily obtainable clinical characteristics in a group of 375 placebo-treated patients with NRAF and a recent episode of transient or nondisabling cerebral ischemia who were entered in a multicenter clinical trial . The mean follow-up was 1.6 years . RESULTS By means of multivariate modeling , six independent variables were identified : history of previous thromboembolism , ischemic heart disease , enlarged cardiothoracic ratio on chest roentgenogram , systolic blood pressure greater than 160 mm Hg at study entry , NRAF for more than 1 year , and presence of an ischemic lesion on CT scan . These variables could also be used to stratify patients in low- , medium- , and high-risk subgroups for the other two arms of the trial , those treated with anticoagulation and aspirin . Patients older than 75 years with three or more risk factors seemingly benefited less from both aspirin and anticoagulant treatment . CONCLUSIONS Easily obtainable patient characteristics are helpful in estimating the potential effect of adequate secondary prevention in patients with NRAF who recently suffered a transient ischemic attack or minor ischemic stroke",
"Transesophageal echocardiography visualizes the left atrium and its appendage and is more sensitive than transthoracic echocardiography for diagnosing thrombi of the left atrium and the left atrial appendage and spontaneous echocardiographic contrast of the left atrium [ 1 - 3 ] . The left atrium and especially the left atrial appendage are the presumed sites of thrombus formation and sources of arterial emboli in patients with atrial fibrillation [ 4 ] . Patients with atrial fibrillation and a history of stroke or embolism were shown to have a higher prevalence of thrombi of the left atrium or the left atrial appendage , a higher prevalence of spontaneous echocardiographic contrast , and a larger left atrial appendage than patients with no history of stroke or embolism [ 2 , 5 , 6 ] . However , whether these abnormalities are predictors for stroke or embolism remains controversial [ 7 , 8 ] . Furthermore , no studies have determined whether transesophageal echocardiography helps to assess risk for stroke or embolism in out patients with atrial fibrillation who have no history of stroke or embolism or whether transesophageal echocardiography is useful in the decision to initiate anticoagulation . We therefore performed a prospect i ve , multicenter study of out patients with atrial fibrillation who had not recently had stroke . We sought to determine whether thrombi of the left atrium or the left atrial appendage , spontaneous echocardiographic contrast , and size of the left atrial appendage are associated with stroke or embolism . Our hypothesis was that patients with thrombi of the left atrium or the left atrial appendage , spontaneous echocardiographic contrast , and enlargement of the left atrial appendage have a higher rate of stroke or embolism than do patients without these abnormalities . The baseline clinical and echocardiographic characteristics of our study sample have been reported elsewhere [ 9 ] . Methods Patient Recruitment Our study was conducted in Austria and Slovakia . At the beginning of the study , general practitioners and internists from surrounding participating centers were informed about the study and were asked to refer patients who had constant or intermittent atrial fibrillation . At each patient 's first visit , a cardiologist recorded baseline data , associated illnesses , clinical characteristics ( definitions of which are listed in Appendix 2 ) , and the cause of atrial fibrillation . A 12-lead electrocardiogram was recorded on 2 separate days . We excluded patients with prosthetic valves and those who were already receiving anticoagulation . Current therapy with aspirin was not an exclusion criterion . Patients who had mitral valve stenosis or had recently had stroke were excluded because anticoagulation was indicated for such conditions . For the definition of recent stroke , we chose a cutoff value of 1 year because a previous study reported that the risk for recurrent stroke was increased in patients who had had an ischemic event in the previous year [ 10 ] . Echocardiography For transthoracic echocardiography , 2.5- or 3.5-MHz probes were used . For M-mode measurements , we applied the recommendations of the American Society of Echocardiography [ 11 ] . M-mode measurements were performed on-line and were documented on printouts . Regional wall-motion and valvular abnormalities were recorded . In patients without regional wall-motion abnormalities , left ventricular systolic function was assessed by calculation of left ventricular fractional shortening . For transesophageal echocardiography , biplane 5-MHz probes were used in 64 % of the patients and monoplane 5-MHz probes were used in 36 % . After local anesthesia with lidocaine spray was administered , the probe was introduced into the nonse date d patients , who lay on their left side . The entire study was recorded on S-VHS videotapes . The cardiac chambers and valves were investigated by using all obtainable views [ 12 , 13 ] . Special care was taken to visualize the whole cavity of the left atrium and its appendage from different planes , with the tip of the probe slightly flexed . The size of the left atrial appendage was measured off-line . A frame that best visualized the left atrial appendage with respect to its orifice , extension , and delineation of borders was selected just before the QRS complex . The length of the left atrial appendage was defined as the distance between the limbus of the left superior pulmonary vein and the apex of the left atrial appendage ; the width of the left atrial appendage was defined as the longest distance between the lateral and ventricular left atrial appendage wall , measured in a line perpendicular to the course of the left atrial appendage curvature ; and the left atrial appendage area was defined as described elsewhere [ 14 ] . For the assessment of intra- and interobserver deviations , left atrial appendage size was measured 1 year after the initial measurement in 20 r and omly selected video recordings by the same observer and in 60 r and omly selected video recordings by three observers from different centers . A thrombus of the left atrium or left atrial appendage was considered definite if at least three of the following five criteria were present : clear borders , echogenicity different from that of surrounding structures , independent mobility , longest diameter greater than 15 mm , and evidence of thrombus in more than one imaging plane [ 15 ] . A second observer from a different center review ed video recordings to confirm diagnosis of thrombus of the left atrium or left atrial appendage . A thrombus was considered probable if only two criteria were present or if the observers disagreed . Spontaneous echocardiographic contrast was diagnosed in the presence of dynamic smoke-like echoes within the left atrium or left atrial appendage with a characteristic swirling motion that was distinct from white noise artifact [ 16 ] . When spontaneous echocardiographic contrast was suspected , the gain setting s were decreased in a stepwise manner to exclude artifact caused by excessive gain . The compression and gain controls were then adjusted to ensure the best possible visualization . Spontaneous echocardiographic contrast was not quantified . A second observer from a different center checked the diagnosis of spontaneous echocardiographic contrast by review ing all video recordings . When the observers disagreed about the presence or absence of spontaneous echocardiographic contrast , the decision made at the time of examination was chosen . This was done because spontaneous echocardiographic contrast was not always visible on review of the video recordings . Outcome Events Primary events were stroke and embolism that extended to viscera or extremities . Stroke was defined as acute onset of a focal neurologic deficit that lasted more than 24 hours and was consistent with a vascular event . Severity and subtypes of stroke were assessed according to established criteria [ 17 ] . Embolism extending to viscera or extremities was defined as a sudden onset of pain that was associated with typical findings on Doppler ultrasonography , angiography , surgery , or autopsy . Secondary events were the need for anticoagulation during follow-up in patients who were primarily receiving aspirin and death not caused by stroke or embolism . Death not caused by stroke or embolism was classified as cardiac or noncardiac on the basis of information from the treating physician and the patient 's family . Follow-up Visits took place 3 , 6 , 12 , 18 , and 24 months after study entry . After a follow-up period of at least 2 years ( ending in February 1994 ) , it was evident that the number of primary outcome events was low . We therefore prolonged the follow-up period and planned further visits , one to be held in 1994 and one to be held in 1995 . Patients who were unwilling or unable to attend the visits were contacted by telephone . Medical records were obtained for patients who had been admitted to a hospital . If a patient had died , an autopsy report or death certificate was obtained . Treatment and Ethical Considerations Although our study was design ed to be observational , we recommended antithrombotic treatment to the patients because of ethical considerations . Because patients with thrombi of the left atrium or left atrial appendage are considered to have a high risk for embolism , we recommended that they receive anticoagulation . The target range for the international normalized ratio was 2.0 to 3.0 , and the treating physicians monitored the ratio [ 5 , 18 ] . We recommended that the remaining patients receive aspirin , 160 mg/d , because preliminary data indicated that aspirin reduces the risk for stroke or embolism in patients with atrial fibrillation [ 19 ] . The institutional review board of the participating centers approved the study . Patients were informed about the background and the procedures of the trial , and informed consent was obtained according to the rules of each center . Statistical Analysis For baseline data , group comparisons were done by analysis of variance for normally distributed data and by the nonparametric Kruskal-Wallis test for data that were not normally distributed . If appropriate , we used the Scheffe post hoc test . The Wilk-Shapiro test was used to check for normality . Contingency table methods , including the chi-square test and the Fisher exact test , were used to analyze categorical data . We used the Cox proportional-hazards model to obtain estimates of relative risk and 95 % CIs for all univariate and multivariate analyses of time-to-event data . All tests were two-sided . The level of significance assumed was an level of 0.05 . We used SAS software ( SAS Institute , Cary , North Carolina ) for analyses . Role of Funding Sources The funding sources had no role in the collection , analysis , or interpretation of the data ; did not review the manuscript at any time ; and were not involved in su bmi tting the paper for publication . Results Patients Patients were recruited between January 1990 and February 1992 . Of the 474",
"PURPOSE R and omized controlled trials have demonstrated that anticoagulant therapy is very effective at preventing stroke among patients with nonrheumatic atrial fibrillation . However , these trials have reported too few strokes for powerful risk factor analysis . Observational studies may provide additional information . The purpose of this study was to identify risk factors in a larger number of patients with stroke and nonrheumatic atrial fibrillation , using case-control methodology . PATIENTS AND METHODS We identified all patients discharged from one hospital over an 8-year period who met our case definition of nonrheumatic atrial fibrillation and ischemic stroke ( n = 134 ) , and compared them with contemporaneous control subjects who were discharged with nonrheumatic atrial fibrillation without stroke ( n = 131 ) . RESULTS Cases and controls were similar in terms of duration of atrial fibrillation ; proportion with paroxysmal atrial fibrillation ; percentage with a past medical history of angina , myocardial infa rct ion , congestive heart failure , diabetes , or smoking ; and mean left atrial size . In contrast , cases were significantly older than controls ( 78.5 versus 74.8 years , p = 0.002 ) and more likely to have a history of hypertension ( 55 % versus 38 % , p = 0.0093 ) . The relative odds for stroke was 1.91 for patients with hypertension , 1.73 for patients older than 75 years , and 3.26 for patients with both factors . CONCLUSIONS Our analysis suggests that age and hypertension should be considered when deciding upon long-term anticoagulant therapy to prevent stroke in patients with nonrheumatic atrial fibrillation",
"BACKGROUND The presence of vascular disease ( peripheral artery disease [ PAD ] and /or myocardial infa rct ion [ MI ] ) may impact on the risk of stroke and death among patients with incident atrial fibrillation ( AF ) . To test this hypothesis , we analyzed data from a large Danish prospect i ve cohort , the Danish Diet , Cancer and Health ( DCH ) study , to assess the risk of stroke or death among those who developed AF according to concomitant presence of vascular disease . METHODS A prospect i ve cohort study of 57 , 053 persons ( 27 , 178 men and 29 , 876 women , respectively ) , aged between 50 and 64 years . The risk of stroke or death for patients with vascular disease was assessed amongst 3315 patients with incident AF ( mean age , 67.1years ; 2130 men , 1185 women ) using Cox proportional hazard models , after a median follow-up of 4.8 years . RESULTS Of the subjects with AF , 417 ( 12.6 % ) had ' vascular disease ' ( PAD and /or prior MI ) . The risk of the primary endpoint ( stroke or death ) was significantly higher in patients with vascular disease at 1-year follow-up ( crude hazard ratio [ HR ] 2.51 [ 1.91 - 3.29 ] ) , with corresponding crude HRs for PAD and MI being 3.51 ( 2.40 - 5.13 ) , and 1.99 ( 1.46 - 2.72 ) , respectively . For the secondary endpoints of death or stroke individually , these risk estimates were similar ( crude HR 2.48 [ 1.89 - 3.26 ] and 1.77 [ 1.18 - 2.66 ] , respectively ) . After adjustment for risk factors within the CHADS(2 ) score , the adjusted HR for the primary endpoint ( stroke or death ) in patients with vascular disease was 1.91 ( 1.44 - 2.54 ) , which was also significant for death ( 1.97 [ 1.48 - 2.62 ] ) . CONCLUSION Vascular disease ( prior MI and PAD ) is an independent risk factor for the primary endpoint of ' stroke or death ' in patients with AF , even after adjustment for the CHADS(2 ) risk score , although this is driven by the impact on mortality . This reaffirms that patients with vascular disease represent a ' high-risk ' population , which necessitates proactive management of all cardiovascular risk factors and effective thromboprophylaxis ( i.e. oral anticoagulation ) , which has been shown to significantly reduce the risk of stroke and death in AF",
"BACKGROUND Anticoagulants are more effective than antiplatelet agents at reducing stroke risk in patients with atrial fibrillation , but whether this benefit outweighs the increased risk of bleeding in elderly patients is unknown . We assessed whether warfarin reduced risk of major stroke , arterial embolism , or other intracranial haemorrhage compared with aspirin in elderly patients . METHODS 973 patients aged 75 years or over ( mean age 81.5 years , SD 4.2 ) with atrial fibrillation were recruited from primary care and r and omly assigned to warfarin ( target international normalised ratio 2 - 3 ) or aspirin ( 75 mg per day ) . Follow-up was for a mean of 2.7 years ( SD 1.2 ) . The primary endpoint was fatal or disabling stroke ( ischaemic or haemorrhagic ) , intracranial haemorrhage , or clinical ly significant arterial embolism . Analysis was by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N89345269 . FINDINGS There were 24 primary events ( 21 strokes , two other intracranial haemorrhages , and one systemic embolus ) in people assigned to warfarin and 48 primary events ( 44 strokes , one other intracranial haemorrhage , and three systemic emboli ) in people assigned to aspirin ( yearly risk 1.8%vs 3.8 % , relative risk 0.48 , 95 % CI 0.28 - 0.80 , p=0.003 ; absolute yearly risk reduction 2 % , 95 % CI 0.7 - 3.2 ) . Yearly risk of extracranial haemorrhage was 1.4 % ( warfarin ) versus 1.6 % ( aspirin ) ( relative risk 0.87 , 0.43 - 1.73 ; absolute risk reduction 0.2 % , -0.7 to 1.2 ) . INTERPRETATION These data support the use of anticoagulation therapy for people aged over 75 who have atrial fibrillation , unless there are contraindications or the patient decides that the benefits are not worth the inconvenience",
"OBJECTIVE To examine the cost-effectiveness of prescribing warfarin sodium in patients who have nonvalvular atrial fibrillation ( NVAF ) with or without additional stroke risk factors ( a prior stroke or transient ischemic attack , diabetes , hypertension , or heart disease ) . DESIGN Decision and cost-effectiveness analyses . The probabilities for stroke , hemorrhage , and death were obtained from published r and omized controlled trials . The quality -of-life estimates were obtained by interviewing 74 patients with atrial fibrillation . Costs were estimated from literature review , phone survey , and Medicare reimbursement . PATIENTS In the base case , the patients were 65 years of age and good c and i date s for warfarin therapy . INTERVENTIONS Treatment with warfarin , aspirin , or no therapy in the decision analytic model . MAIN OUTCOME MEASURES Quality -adjusted survival and marginal cost-effectiveness of warfarin as compared with aspirin or no therapy . RESULTS For patients with NVAF and additional risk factors for stroke , warfarin therapy led to a greater quality -adjusted survival and to cost savings . For patients with NVAF and one additional risk factor , warfarin therapy cost $ 8000 per quality -adjusted life-year saved . For 65-year-old patients with NVAF alone , warfarin cost about $ 370,000 per quality -adjusted life-year saved , as compared with aspirin therapy . However , for 75-year-old patients with NVAF alone , prescribing warfarin cost $ 110,000 per quality -adjusted life-year saved . For patients who were not prescribed warfarin , aspirin was preferred to no therapy on the basis of both quality -adjusted survival and cost in all patients , regardless of the number of risk factors present . CONCLUSIONS Treatment with warfarin is cost-effective in patients with NVAF and one or more additional risk factors for stroke . In 65-year-old patients with NVAF but no other risk factors for stroke , prescribing warfarin instead of aspirin would affect quality -adjusted survival minimally but increase costs significantly",
"BACKGROUND Clinical features that consistently predict ischemic stroke in patients with nonvalvular atrial fibrillation have been identified , while echocardiographic risk factors are less well defined . OBJECTIVE To determine whether the results of transthoracic echocardiography add independent information to the clinical risk factors for stroke in patients with atrial fibrillation . METHODS Transthoracic echocardiographic findings and clinical features from 1066 patients with atrial fibrillation assigned to placebo or control in 3 r and omized trials ( Boston Area Anticoagulation Trial for Atrial Fibrillation , Stroke Prevention in Atrial Fibrillation I Study , and Veterans Affairs Prevention in Atrial Fibrillation Study ) were correlated with subsequent ischemic stroke by multivariate analysis . RESULTS The mean + SD age of patients was 67 + /- 10 years , 78 % were men , 55 % had a history of hypertension , 19 % had a history of diabetes , 7 % had a previous transient ischemic attack or stroke , and 27 % had a history of heart failure . During a mean follow-up of 1.6 years , 78 ischemic strokes occurred ( annual rate , 4.7 % ) . Moderate to severe left ventricular systolic dysfunction shown via 2-dimensional echocardiography was a strong independent predictor of stroke ( relative risk , 2.5 ; P stroke ( relative risk , 1.02/mm ; P = .10 ) . Of 163 patients categorized as low risk based on clinical features ( annual stroke rate , 0.8 % ; 95 % confidence interval , 0.2%-3.0 % ) , 10 had moderate to severe left ventricular dysfunction shown via 2-dimensional echocardiography and a 9.3 % per year risk of stroke ( 95 % confidence interval , 1.3%-66 % ) . Conversely , 728 of the 847 patients at high risk for stroke based on clinical criteria had normal or mildly abnormal left ventricular function ; their stroke rate was 4.4 % ( 95 % confidence interval , 3.4%-5.8 % ) . CONCLUSIONS Left ventricular systolic dysfunction shown via 2-dimensional transthoracic echocardiography independently predicts risk of stroke in patients with atrial fibrillation . Echocardiography may prove most useful in a small group of patients who have a low risk of stroke according to clinical factors",
"CONTEXT Warfarin has been shown to be highly efficacious for preventing thromboembolism in atrial fibrillation in r and omized trials , but its effectiveness and safety in clinical practice is less clear . OBJECTIVE To evaluate the effect of warfarin on risk of thromboembolism , hemorrhage , and death in atrial fibrillation within a usual care setting . DESIGN Cohort study assembled between July 1 , 1996 , and December 31 , 1997 , and followed up through August 31 , 1999 . SETTING Large integrated health care system in Northern California . PATIENTS Of 13,559 adults with nonvalvular atrial fibrillation , 11,526 were studied , 43 % of whom were women , mean age 71 years , with no known contraindications to anticoagulation at baseline . MAIN OUTCOMES Ischemic stroke , peripheral embolism , hemorrhage , and death according to warfarin use and comorbidity status , as determined by automated data bases , review of medical records , and state mortality files . RESULTS Among 11,526 patients , 397 incident thromboembolic events ( 372 ischemic strokes , 25 peripheral embolism ) occurred during 25,341 person-years of follow-up , and warfarin therapy was associated with a 51 % ( 95 % confidence interval [ CI ] , 39%-60 % ) lower risk of thromboembolism compared with no warfarin therapy ( either no antithrombotic therapy or aspirin ) after adjusting for potential confounders and likelihood of receiving warfarin . Warfarin was effective in reducing thromboembolic risk in the presence or absence of risk factors for stroke . A nested case-control analysis estimated a 64 % reduction in odds of thromboembolism with warfarin compared with no antithrombotic therapy . Warfarin was also associated with a reduced risk of all-cause mortality ( adjusted hazard ratio , 0.69 ; 95 % CI , 0.61 - 0.77 ) . Intracranial hemorrhage was uncommon , but the rate was moderately higher among those taking vs those not taking warfarin ( 0.46 vs 0.23 per 100 person-years , respectively ; P = .003 , adjusted hazard ratio , 1.97 ; 95 % CI , 1.24 - 3.13 ) . However , warfarin therapy was not associated with an increased adjusted risk of nonintracranial major hemorrhage . The effects of warfarin were similar when patients with contraindications at baseline were analyzed separately or combined with those without contraindications ( total cohort of 13,559 ) . CONCLUSIONS Warfarin is very effective for preventing ischemic stroke in patients with atrial fibrillation in clinical practice while the absolute increase in the risk of intracranial hemorrhage is small . Results of r and omized trials of anticoagulation translate well into clinical care for patients with atrial fibrillation",
"AIMS We aim ed to investigate the prevalence and incidence of atrial fibrillation ( AF ) in a large European population -based study . METHODS AND RESULTS The study is part of the Rotterdam study , a population -based prospect i ve cohort study among subjects aged 55 years and above . The prevalence at baseline was assessed in 6808 participants . Incidence of AF was investigated during a mean follow-up period of 6.9 years in 6432 persons . We identified 376 prevalent and 437 incident cases . Overall prevalence was 5.5 % , rising from 0.7 % in the age group 55 - 59 years to 17.8 % in those aged 85 years and above . The overall incidence rate was 9.9/1000 person-years . The incidence rate in the age group 55 - 59 years was 1.1/1000 person-years , rose to 20.7/1000 person-years in the age group 80 - 84 years and stabilized in those aged 85 years and above . Prevalence and incidence were higher in men than in women . The lifetime risk to develop AF at the age of 55 years was 23.8 % in men and 22.2 % in women . CONCLUSION In this prospect i ve study in a European population , the prevalence and incidence of AF increased with age and were higher in men than in women . The high lifetime risk to develop AF was similar to North American epidemiological data",
"BACKGROUND Warfarin reduces the risk for ischemic stroke in patients with atrial fibrillation ( AF ) but increases the risk for hemorrhage . Dabigatran is a fixed-dose , oral direct thrombin inhibitor with similar or reduced rates of ischemic stroke and intracranial hemorrhage in patients with AF compared with those of warfarin . OBJECTIVE To estimate the quality -adjusted survival , costs , and cost-effectiveness of dabigatran compared with adjusted-dose warfarin for preventing ischemic stroke in patients 65 years or older with nonvalvular AF . DESIGN Markov decision model . DATA SOURCES The RE-LY ( R and omized Evaluation of Long-Term Anticoagulation Therapy ) trial and other published studies of anticoagulation . The cost of dabigatran was estimated on the basis of pricing in the United Kingdom . TARGET POPULATION Patients aged 65 years or older with nonvalvular AF and risk factors for stroke ( CHADS₂ score ≥1 or equivalent ) and no contraindications to anticoagulation . TIME HORIZON Lifetime . PERSPECTIVE Societal . INTERVENTION Warfarin anticoagulation ( target international normalized ratio , 2.0 to 3.0 ) ; dabigatran , 110 mg twice daily ( low dose ) ; and dabigatran , 150 mg twice daily ( high dose ) . OUTCOME MEASURES Quality -adjusted life-years ( QALYs ) , costs ( in 2008 U.S. dollars ) , and incremental cost-effectiveness ratios . RESULTS OF BASE-CASE ANALYSIS The quality -adjusted life expectancy was 10.28 QALYs with warfarin , 10.70 QALYs with low-dose dabigatran , and 10.84 QALYs with high-dose dabigatran . Total costs were $ 143 193 for warfarin , $ 164 576 for low-dose dabigatran , and $ 168 398 for high-dose dabigatran . The incremental cost-effectiveness ratios compared with warfarin were $ 51 229 per QALY for low-dose dabigatran and $ 45 372 per QALY for high-dose dabigatran . RESULTS OF SENSITIVITY ANALYSIS The model was sensitive to the cost of dabigatran but was relatively insensitive to other model inputs . The incremental cost-effectiveness ratio increased to $ 50 000 per QALY at a cost of $ 13.70 per day for high-dose dabigatran but remained less than $ 85 000 per QALY over the full range of model inputs evaluated . The cost-effectiveness of high-dose dabigatran improved with increasing risk for stroke and intracranial hemorrhage . LIMITATION Event rates were largely derived from a single r and omized clinical trial and extrapolated to a 35-year time frame from clinical trials with approximately 2-year follow-up . CONCLUSION In patients aged 65 years or older with nonvalvular AF at increased risk for stroke ( CHADS₂ score ≥1 or equivalent ) , dabigatran may be a cost-effective alternative to warfarin depending on pricing in the United States . PRIMARY FUNDING SOURCE American Heart Association and Veterans Affairs Health Services Research & Development Service",
"BACKGROUND AND PURPOSE Previous cost-effectiveness analyses analyzed warfarin for stroke prevention in r and omized trial setting s. Given the complexities of warfarin treatment , cost-effectiveness should be examined within a real-world setting . METHODS Our model followed patients with atrial fibrillation at moderate to high risk of stroke through primary and recurrent ischemic stroke , hemorrhages -- intracranial and extracranial , and the result ing disability . Four scenarios were examined : ( 1 ) all patients start on warfarin with perfect control , that is , international normalized ratio ( INR ) values always within range ; ( 2 ) all patients start on warfarin with trial-like control , where INR can fall outside the recommended range ; ( 3 ) all patients start on warfarin with real-world INR control ; and ( 4 ) real-world prescription ( and control ) of warfarin , aspirin , or neither for warfarin-eligible patients . Reported warfarin discontinuation rates were used . Main outcomes were total number of events , quality adjusted life years , and costs in a US setting . RESULTS The total number of primary and recurrent ischemic strokes in a 1,000-patient cohort ( age 70 years , lifetime analysis ) was 626 , 832 , 984 , and 1,171 in scenarios 1 to 4 , respectively . The corresponding mean quality adjusted life years per patient were 7.21 , 6.92 , 6.75 , and 6.67 for scenarios 1 to 4 , respectively . Costs per patient were $ 68,039 , $ 77,764 , $ 84,518 , and $ 87,248 in scenarios 1 to 4 , respectively . If \" perfect \" adherence to warfarin was assumed , except for discontinuations for clinical reasons , strokes would decrease to 503 , 737 , 909 , and 1,120 in scenarios 1 to 4 , respectively . CONCLUSIONS Clinical and cost outcomes are strongly dependent on the quality of anticoagulation and rates of warfarin discontinuation . Clinicians should work to improve both . Policy makers should use real-world INR control and warfarin discontinuation rates when assessing cost-effectiveness",
"As previously reported , 1007 patients with chronic atrial fibrillation participated in the Copenhagen AFASAK study . Before inclusion to trial , they all had a physical examination , chest roentgenogram , and echocardiogram with determination of left atrial size . This study evaluated the importance of cardiovascular risk factors for development of thromboembolic complications . To exclude any treatment effects on occurrence of thromboembolic complications , we included only the 336 patients from the placebo group . Using Cox 's regression model , previous myocardial infa rct ion was a significant risk factor for development of thromboembolic complications . Age , gender , heart failure , chest pain , hypertensive heart disease , diabetes , systolic and diastolic blood pressure , smoking , relative heart volume , and left atrial size were all without statistical importance",
"PURPOSE The risk of ischemic stroke varies widely among patients with nonvalvular atrial fibrillation , influencing the choice of prophylactic antithrombotic therapy . We assessed three schemes for stroke risk stratification in these patients who were treated with aspirin and who did not have prior cerebral ischemia . SUBJECTS AND METHODS Criteria from three schemes of risk stratification were applied to a longitudinally observed cohort of patients with atrial fibrillation who did not have prior cerebral ischemia and who were treated with aspirin alone or aspirin combined with low , ineffective doses of warfarin in a multicenter clinical trial . The ability of the schemes to identify patients at high ( > /=6 % ) , low ( /=2 % ) , and intermediate annual risks of ischemic stroke was assessed . RESULTS During a mean follow-up of 1.8 years , 48 ischemic strokes occurred among 1,073 patients with atrial fibrillation who were taking aspirin ( rate = 2.5 per 100 person-years ) . Each of the three schemes predicted stroke and disabling stroke , and successfully identified patients at low risk ( observed stroke rates of 0.3 to 1.1 per 100 person-years ) , although the fractions of the cohort that were categorized as low risk varied from 14 % to 45 % . The observed rates of ischemic stroke among patients categorized as high risk ranged from 3.5 to 7.2 per 100 person-years among the stratification schemes . Two schemes considered all patients > 75 years old as high risk ( observed stroke rate 4.2 per 100 person-years ) , while the remaining scheme classified one third of patients in this age group as low risk ( observed stroke rate 0.6 per 100 person-years ) . CONCLUSIONS When tested in a large cohort of patients with atrial fibrillation who were treated with aspirin , available risk-stratification schemes successfully identified patients with low rates of ischemic stroke , but less consistently identified high-risk patients",
"OBJECTIVES The purpose of this study was to investigate predictors of bleeding in a cohort of anticoagulated patients and to evaluate the predictive value of several bleeding risk stratification schemas . BACKGROUND The risk of bleeding during antithrombotic therapy in patients with atrial fibrillation ( AF ) is not homogeneous , and several clinical risk factors have been incorporated into clinical bleeding risk stratification schemas . Current risk stratification schemas for bleeding during anticoagulation therapy have been based on complex scoring systems that are difficult to apply in clinical practice , and few have been derived and vali date d in AF cohorts . METHODS We investigated predictors of bleeding in a cohort of 7,329 patients with AF participating in the SPORTIF ( Stroke Prevention Using an ORal Thrombin Inhibitor in Atrial Fibrillation ) III and V clinical trials and evaluated the predictive value of several risk stratification schemas by multivariate analysis . Patients were anticoagulated orally with either adjusted-dose warfarin ( target international normalized ratio 2 to 3 ) or fixed-dose ximelagatran 36 mg twice daily . Major bleeding was central ly adjudicated , and concurrent aspirin therapy was allowed in patients with clinical atherosclerosis . RESULTS By multivariate analyses , significant predictors of bleeding were concurrent aspirin use ( hazard ratio [ HR ] : 2.10 ; 95 % confidence interval [ CI ] : 1.59 to 2.77 ; p renal impairment ( HR : 1.98 ; 95 % CI : 1.42 to 2.76 ; p age 75 years or older ( HR : 1.63 ; 95 % CI : 1.23 to 2.17 ; p = 0.0008 ) ; diabetes ( HR : 1.47 ; 95 % CI : 1.10 to 1.97 ; p = 0.009 ) , and heart failure or left ventricular dysfunction ( HR : 1.32 ; 95 % CI : 1.01 to 1.73 ; p = 0.041 ) . Of the tested schemas , the new HAS-BLED ( Hypertension , Abnormal Renal/Liver Function , Stroke , Bleeding History or Predisposition , Labile INR , Elderly , Drugs/Alcohol Concomitantly ) score performed best , with a stepwise increase in rates of major bleeding with increasing HAS-BLED score ( p(trend ) c statistic for bleeding varied between 0.50 and 0.67 in the overall entire cohort and 0.68 among patients naive to warfarin at baseline ( n = 769 ) . CONCLUSIONS This analysis identifies diabetes and heart failure or left ventricular dysfunction as potential risk factors for bleeding in AF beyond those previously recognized . Of the contemporary bleeding risk stratification schemas , the new HAS-BLED scheme offers useful predictive capacity for bleeding over previously published schemas and may be simpler to apply"
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OBJECTIVE To evaluate the effects of home-based supervised exercise vs hospital-based supervised exercise , and the effects of home-based supervised exercise vs unsupervised " go home and walk advice " on daily life and corridor-walking capacity , health-related quality of life and patient-reported functional walking capacity in patients with intermittent claudication . DATA SOURCES Systematic literature search es were conducted in PubMed , EMBASE , ProQuest , the Cumulative Index to Nursing and Allied Health Literature ( CINAHL ) , the Allied and Complementary Medicine Data base ( AMED ) , the Cochrane Library , and a number of Health Technology Assessment (HTA)- data bases in October 2014 . STUDY SELECTION R and omized controlled trials and non-r and omized controlled trials ( > 100 patients ) were considered for inclusion . DATA EXTRACTION Data extraction and risk of bias assessment was performed independently and discussed in meetings . DATA SYNTHESIS Seven r and omized controlled trials and 2 non-r and omized controlled studies fulfilled the inclusion criteria . The included studies had some , or major , limitations . CONCLUSION Based on a low quality of evidence , home-based supervised exercise may lead to less improvement in maximum and pain-free walking distance , and in more improvement in daily life walking capacity , compared with hospital-based supervised exercise . Home-based supervised exercise may improve maximum and pain-free walking distance compared with " go home and walk advice " and result in little or no difference in health-related quality of life and functional walking capacity compared with hospital-based supervised exercise or " go home and walk advice " . Further research is needed to establish the optimal exercise modality for these patients | [
"OBJECTIVE The efficacy of polestriding exercise ( walking with modified ski poles with a movement pattern similar to cross-country skiing ) to increase exercise tolerance of persons with intermittent claudication pain caused by peripheral arterial disease was tested in this 24-week prospect i ve r and omized clinical trial . METHODS The study was conducted in a Department of Veterans Affairs Hospital with 52 individuals who gave written informed consent and were r and omized into either a polestriding exercise ( n = 27 ; age , 65.5 + /- 7.0 years ; ankle brachial index , 0.64 + /- 0.25 ) or nonexercise control ( n = 25 ; age , 68.6 + /- 8.9 years ; ankle brachial index , 0.69 + /- 0.14 ) group ( P > .05 for all comparisons ) . The polestriding exercise program consisted of supervised training three times per week for 4 weeks , two times per week for 8 weeks , one time per week for 4 weeks , biweekly for 4 weeks and unsupervised training for 4 weeks . Starting in week 5 , subjects took their poles home with instructions to repeat the most recent supervised training walk at an appropriate and convenient location near their residence . This was referred to as unsupervised but directed exercise . Subjects were provided with a personal log book for documenting unsupervised exercise sessions . With both supervised and unsupervised exercise , subjects were expected to complete a total of four 30-minute to 45-minute polestriding exercise sessions per week . The main outcome measures were exercise duration on symptom-limited incremental treadmill test , Walking Impairment Question naire , rating of perceived leg pain at baseline , 4 , 8 , 12 , 16 , and 24 weeks , and constant work-rate treadmill exercise tests at baseline and at 4 , 12 , and 24 weeks . RESULTS Polestriding significantly ( P exercise tolerance on the constant work-rate and incremental treadmill tests . Ratings of perceived claudication pain were significantly less after the polestriding training program . Subject perceived distance and walking speed scores on the Walking Impairment Question naire improved in the polestriding trained group only ( P polestriding training significantly improves quantitative and qualitative measures of the exercise tolerance of persons limited by intermittent claudication pain",
"BACKGROUND Intermittent claudication is associated with a poor prognosis , but less is known of the risks associated with asymptomatic peripheral arterial disease . The aims of this study were to determine the incidence and natural history of claudication , and the incidence of cardiovascular events in symptomatic and asymptomatic peripheral arterial disease . METHODS In 1988 , 1592 subjects aged 55 - 74 years were selected r and omly from the age-sex register of 10 general practice s in Edinburgh , Scotl and . The presence of peripheral arterial disease was determined by the World Health Organization question naire on intermittent claudication , the ankle brachial pressure index and a reactive hyperaemia test . This cohort was followed prospect ively over 5 years for subsequent cardiovascular events and death . RESULTS One hundred and sixteen new cases of claudication were identified ( incidence density 15.5 per 1000 person-years ) . Of those with claudication at baseline , 28.8 % and still had pain after 5 years , 8.2 % underwent vascular surgery or amputation , and 1.4 % developed leg ulceration . Claudicants had a significantly increased risk of developing angina compared with normals ( RR : 2.31 , 95 % CI : 1.04 - 5.10 ) , and asymptomatic subjects had a slightly increased risk of myocardial infa rct ion and stroke . Deaths from cardiovascular disease were more likely in both claudicants ( RR : 2.67 , 95 % CI : 1.34 - 5.29 ) and subjects with major ( RR : 2.08 , 95 % CI : 1.13 - 3.83 ) or minor asymptomatic disease ( RR : 1.74 , 95 % CI : 1.09 - 2.76 ) . Subjects with major asymptomatic disease also had an increased risk of non-cardiovascular death ( RR : 2.19 , 95 % CI : 1.33 - 3.59 ) , and therefore had the highest overall risk of death ( RR : 2.44 , 95 % CI : 1.59 - 3.74 ) . CONCLUSIONS Subjects with asymptomatic peripheral arterial disease appear to have the same increased risk of cardiovascular events and death found in claudicants",
"OBJECTIVE To compare associations of physical activity during daily life with treadmill walking performance and corridor-based functional performance measures in persons with lower extremity peripheral arterial disease ( PAD ) . STUDY DESIGN Cross-sectional . SUBJECTS One hundred fifty-six men and women with PAD who completed baseline measurements and were r and omized into the study to improve leg circulation ( SILC ) exercise clinical trial . MAIN OUTCOME MEASURES Participants completed a Gardner-Skinner treadmill protocol . Corridor-based functional performance measures were the 6-minute walk , walking velocity over four meters at usual and fastest pace , and the short physical performance battery ( SPPB ) ( 0 - 12 scale , 12 = best ) . Physical activity during daily life was measured continuously over 7 days with a Caltrac ( Muscle Dynamics Fitness Network , Inc , Torrence , Calif ) accelerometer . RESULTS Adjusting for age , gender , and race , higher levels of physical activity during daily life were associated with greater distance achieved in the 6-minute walk ( P trend = .001 ) , faster fast-paced four-meter walking velocity ( P trend usual-paced four-meter walking speed ( P trend = .027 ) and a higher SPPB ( P trend = .005 ) . The association of physical activity level with maximum treadmill walking distance did not reach statistical significance ( P trend = .083 ) . There were no associations of physical activity with treadmill distance to onset of leg symptoms ( P trend = .795 ) . CONCLUSION Functional performance measures are more strongly associated with physical activity levels during daily life than treadmill walking measures",
"The aims of the study were to determine whether heart rate variability ( HRV ) measured at rest and during exercise could be altered by an exercise training programme design ed to increase walking performance in patients with peripheral arterial disease . Forty-four volunteers were r and omised into 12 weeks of either : supervised walking training twice weekly for 30 min at 75 % VO2peak ( SU ) , home-based walking training sessions : twice weekly , 30 min per week ( HB ) or no exercise ( CT ) . HRV measures were calculated from a 5-min resting ECG . Each patient then underwent maximal , grade d exercise treadmill testing . All measures were repeated after 12 weeks . The SU group showed significantly ( p maximal walking time ( MWT ) but no change in VO2peak . There were no statistically significant changes in any of the measures of HRV in any group . Effect sizes for change in HRV measures were all very small and in some cases negative . Improved walking performance was not accompanied by central cardiorespiratory or neuroregulatory adaptations in the present study . The lack of any change in HRV was possibly due to either the low intensity or discontinuous nature of exercise undertaken . Key pointsIt is known that exercise can positively influence heart rate variability in some cardiac patients .It is known that exercise can increase walking performance in peripheral vascular disease patients .Exercise training improved walking performance in peripheral vascular disease patients but HRV was unaltered . This may be due to low overall physiological dem and s on the cardiovascular system or the intermittent nature of the exercise",
"Supervised , hospital-based exercise rehabilitation programs are effective for improving functional status for patients with claudication due to peripheral arterial occlusive disease . However , it has been suggested that unsupervised , home-based exercise programs , which have been relatively little evaluated , would be equally efficacious as compared with hospital-based programs . The authors tested the hypothesis that a hospital-based exercise rehabilitation program would improve treadmill exercise perfor mance more than a home-based program . Of 20 consecutively enrolled patients with claudication , 10 were r and omly placed into a supervised , hospital-based program and 10 into an unsupervised , home-based program for a three-month period . Exercise perfor mance was evaluated by treadmill testing using a grade d protocol . In addition , func tional status was evaluated by the Walking Impairment Question naire ( WIQ ) and the Medical Outcomes Study SF-20 question naire ( MOS ) . Patients in the hospital-based program were treated with treadmill walking three times a week for one hour/visit . Patients in the home-based program were instructed to walk at least three times a week and were contacted weekly to provide encouragement and to record compliance with ( continued on next page ) the program . Patients in the hospital-based group improved peak walking time by 137 % , pain-free walking time by 150 % , and peak oxygen consumption by 19 % ( all P walking distance and speed according to WIQ data ( both P MOS physical functioning score in the hospital-based group improved by 20 percentage points ( P exercise performance measured on the treadmill . Improvement in the ability to walk on the treadmill was greater in the hospital-based than the home- based program ( P ability to walk distances was the only question naire measure that improved in persons who received the home-based program ( P improving treadmill exercise performance than an unsupervised , home-based program",
"Background — This prospect i ve , r and omized , controlled clinical trial compared changes in exercise performance and daily ambulatory activity in peripheral artery disease patients with intermittent claudication after a home-based exercise program , a supervised exercise program , and usual-care control . Methods and Results — Of the 119 patients r and omized , 29 completed home-based exercise , 33 completed supervised exercise , and 30 completed usual-care control . Both exercise programs consisted of intermittent walking to nearly maximal claudication pain for 12 weeks . Patients wore a step activity monitor during each exercise session . Primary outcome measures included claudication onset time and peak walking time obtained from a treadmill exercise test ; secondary outcome measures included daily ambulatory cadences measured during a 7-day monitoring period . Adherence to home-based and supervised exercise was similar ( P=0.712 ) and exceeded 80 % . Both exercise programs increased claudication onset time ( P peak walking time ( P home-based exercise increased daily average cadence ( P0.05 ) . The changes in claudication onset time and peak walking time were similar between the 2 exercise groups ( P>0.05 ) , whereas the change in daily average cadence was greater with home-based exercise ( P home-based exercise program , quantified with a step activity monitor , has high adherence and is efficacious in improving claudication measures similar to a st and ard supervised exercise program . Furthermore , home-based exercise appears more efficacious in increasing daily ambulatory activity in the community setting than supervised exercise . Clinical Trial Registration — URL : http://www . Clinical Trials . Gov . Unique identifier : NCT00618670",
"OBJECTIVE Determine the efficacy of a home-based walking intervention to improve walking ability and quality of life in people with diabetes and peripheral arterial disease ( PAD ) . RESEARCH DESIGN AND METHODS We conducted a r and omized , controlled , single-blind trial within university-affiliated clinics in our local community . We r and omized 145 participants ( 45 women ) with diabetes and PAD to our intervention — a 6-month behavioral intervention targeting levels of readiness to engage in routine walking for exercise — versus attention control . Our primary outcome was 6-month change in maximal treadmill walking distance . Secondary outcomes included 3-month change in maximal walking distance , lower limb function ( i.e. , walking impairment scores ) , quality of life ( Medical Outcomes Short Form Survey ) , exercise behaviors , depressive symptoms , and self-efficacy at 3 and 6 months . RESULTS The mean age of participants was 66.5 ( SD 10.1 ) years . Intervention and control groups did not differ significantly in 6-month change in maximal treadmill walking distance ( average [ SE ] 24.5 [ 19.6 ] meters vs. 39.2 [ 19.6 ] meters ; P = 0.60 ) . Among secondary outcomes , for the intervention and control groups , respectively , average walking speed scores increased by 5.7 [ 2.2 ] units and decreased by 1.9 [ 2.8 ] units ( P = 0.03 ) ; the mental health quality of life subscale score increased by 3.2 [ 1.5 ] and decreased by 2.4 [ 1.5 ] units ( P = 0.01 ) . CONCLUSIONS A home-based walking intervention did not improve walking distance but did improve walking speed and quality of life in people with diabetes and PAD . Clinicians should consider recommending home-based walking therapy for such patients",
"Background This prospect i ve , r and omized , controlled clinical trial compared changes in primary outcome measures of claudication onset time ( COT ) and peak walking time ( PWT ) , and secondary outcomes of submaximal exercise performance , daily ambulatory activity , vascular function , inflammation , and calf muscle hemoglobin oxygen saturation ( StO2 ) in patients with symptomatic peripheral artery disease ( PAD ) following new exercise training using a step watch ( NEXT Step ) home‐exercise program , a supervised exercise program , and an attention‐control group . Methods and Results One hundred eighty patients were r and omized . The NEXT Step program and the supervised exercise program consisted of intermittent walking to mild‐to‐moderate claudication pain for 12 weeks , whereas the controls performed light resistance training . Change scores for COT ( P PWT ( P 6‐minute walk distance ( P=0.028 ) , daily average cadence ( P=0.011 ) , time to minimum calf muscle StO2 during exercise ( P=0.025 ) , large‐artery elasticity index ( LAEI ) ( P=0.012 ) , and high‐sensitivity C‐reactive protein ( hsCRP ) ( P=0.041 ) were significantly different among the 3 groups . Both the NEXT Step home program and the supervised exercise program demonstrated a significant increase from baseline in COT , PWT , 6‐minute walk distance , daily average cadence , and time to minimum calf StO2 . Only the NEXT Step home group had improvements from baseline in LAEI , and hsCRP ( P . Conclusions NEXT Step home exercise utilizing minimal staff supervision has low attrition , high adherence , and is efficacious in improving COT and PWT , as well as secondary outcomes of submaximal exercise performance , daily ambulatory activity , vascular function , inflammation , and calf muscle StO2 in symptomatic patients with PAD . Clinical Trial Registration URL : Clinical Trials.gov . Unique Identifier : NCT00618670",
"OBJECTIVES To evaluate effects of a structured home-based exercise program on functional capacity and quality of life ( QoL ) in patients with intermittent claudication ( IC ) after 1-year follow-up , and to compare these results with those from a concurrent control group who received supervised exercise training ( SET ) . DESIGN Comparative longitudinal cohort study . SETTING Referral center . PARTICIPANTS Patients ( N=142 ) with IC . INTERVENTIONS Structured home-based exercise training or SET . MAIN OUTCOME MEASURES The maximum ( pain-free ) walking distance and the ankle-brachial index ( ABI ) ( at rest and postexercise ) were measured at baseline and after 6 and 12 months ' follow-up . Additionally , QoL was evaluated using a self-administered question naire consisting of the Euroqol-5D ( scale 0 - 1 ) , rating scale ( scale 0 - 100 ) , Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ; scale 0 - 100 ) , and the Vascular Quality of Life Question naire ( VascuQol ; scale 1 - 7 ) . Comparison of the groups was performed with adjustment for the nonr and omized setting using propensity scoring . RESULTS One hundred forty-two patients with IC started the structured home-based exercise program , of whom 95 ( 67 % ) completed 12 months ' follow-up . The mean relative improvement compared with baseline was statistically significant after 12 months ' follow-up for the maximum and pain-free walking distance ( 342 % , 95 % confidence interval [ CI ] , 169 - 516 ; P ABI postexercise ( mean change , .06 ; 95 % CI , .01-.10 ; P=.02 ) . For the QoL outcomes , the improvement compared with baseline was statistically significant after 12 months for the VascuQol ( mean change , .42 ; 95 % CI , .20-.65 ; P SF-36 physical functioning ( mean change , 5.17 ; 95 % CI , .77 - 9.56 ; P=.02 ) . Compared with the structured home-based exercise program , patients in the control group showed significantly better results in the mean relative improvement of maximum and pain-free walking distance and change in the ABI at rest after 12 months ' follow-up . CONCLUSIONS Structured home-based exercise training is effective in improving both functional capacity and QoL in patients with IC and may be considered as a feasible and valuable alternative toSET , since supervised exercise programs are not often available",
"OBJECTIVE to assess quality of life ( QOL ) in patients with intermittent claudication . DESIGN a prospect i ve , open study . MATERIAL AND METHOD one hundred and fifty-one consecutive claudicants ( 100 men , 51 women ) , and 161 healthy controls ( 70 men and 91 women ) completed an adapted version of the World Health Organisation Quality of Life Assessment Instrument-100 . RESULTS patients scored significantly worse on the domains Physical health and Level of independence , as well as on the facets Pain and discomfort , Energy and fatigue , Mobility , Activities of daily living , Dependence on medication and treatments , Working capacity , Negative feelings , Recreation and leisure and Overall QOL and general health . Increasing disease to incapacitating claudication affected only the facet Mobility and the domain Level of independence . CONCLUSION QOL in patients with intermittent claudication is reduced in many aspects . Where co-morbidity seems to affect QOL strongly , the effect of walking distance on QOL might be small . These findings may justify a reserved attitude towards invasive , even minimally invasive treatment of these patients",
"PURPOSE This study was performed to test the effectiveness of a formal supervised exercise program against a home-based exercise program for both walking ability and quality of life endpoints . METHODS Patients with arterial claudication were r and omized to either a 12-week supervised exercise program ( SUPEX ) with weekly lectures relating to peripheral vascular disease or to a home exercise group ( HOMEX ) who attended an identical lecture program and received weekly exercise instruction . The study population included 29 men and 26 women , with a mean age of 69.1 + /- 8.1 years . Forty-seven patients completed the 12-week program , 46 were available for testing at completion , and 38 for 6-month testing . Claudication pain time ( CPT ) and maximum walking time ( MWT ) on a progressive treadmill exercise test were assessed at baseline , program completion , and 6 months . The Medical Outcomes Study Short Form-36 ( SF-36 ) was administered at these intervals to assess effects on quality of life . RESULTS Each group improved ( p CPT and MWT at the completion of the 12-week program , which was sustained at the 6-month follow-up . Increase in HOMEX CPT from baseline ( 3.6 + /- 2.73 minutes ) to 6-month follow-up ( 6.6 + /- 3.17 minutes ) was less than for the SUPEX group ( 3.8 + /- 2.74 to 11.2 + /- 4.02 minutes , respectively ) ; similar results were obtained for MWT . At both completion and 6 months , there was a significant intergroup difference for CPT and MWT ( p health perception based on the SF-36 demonstrated improvement ( p Physical Function Subscale , Bodily Pain Subscale , and Physical Composite Score . There were no between-group differences on the subsets of the SF-36 at the three assessment intervals . CONCLUSIONS Supervised exercise programs provide superior increased walking ability in the noninterventional therapy of arterial claudication , and both supervised and home based exercise therapy result in improved SF-36 functional measures . The lack of intergroup differences in these measures may be a result of the high degree of interaction with healthcare providers in the HOMEX group . Although a supervised program results in optimal walking benefits , a highly structured home-based program provides similar functional improvement and may be a satisfactory alternative for patients with lesser walking requirements",
"OBJECTIVES To compare the effect of unsupervised exercise , supervised exercise and intermittent pneumatic foot and calf compression ( IPC ) on the claudication distance , lower limb arterial haemodynamics and quality of life of patients with intermittent claudication . METHODS Thirty-four eligible patients with stable intermittent claudication were r and omised to IPC ( n = 13 , 3h/d for 6 months ) , supervised exercise ( n = 12 , three hourly sessions/week for 6 months ) or unsupervised exercise ( n = 9 ) . In each patient , initial claudication distance ( ICD ) , absolute claudication distance ( ACD ) , resting ankle brachial pressure index ( ABPI ) , and resting hyperaemic calf arterial inflow were measured before , 6 weeks , 6 months and 1 year after r and omisation . Quality of life was assessed with the short form (SF)-36 , walking impairment ( WIQ ) and intermittent claudication question naires ( ICQ ) . RESULTS Compared with unsupervised exercise , both IPC and supervised exercise , increased ICD and ACD , up to 2.83 times . IPC increased arterial inflow ( p ABPI . Supervised exercise decreased arterial inflow and increased ABPI ( p Unsupervised exercise had no effect on arterial inflow or ABPI . IPC improved significantly the ICQ score and the speed score of the WIQ , while supervised exercise improved the WIQ claudication severity score . At 1 year clinical effectiveness of supervised exercise and IPC was largely preserved . CONCLUSIONS IPC , by augmenting leg perfusion , achieved improvement in walking distance comparable with supervised exercise . Long-term results in a larger number of patients will provide valuable information on the optimal treatment modality of intermittent claudication",
"PURPOSE This study was performed to test the efficacy of a supervised , hospital-based exercise program compared with a home-based exercise program involving minimal supervision , for both walking ability and quality of life measures in patients with exercise-limiting intermittent leg claudication . METHODS Twenty-one patients were assigned r and omly to 12 weeks of supervised exercise or to a home-based exercise group . After 12 weeks the participants in the supervised group transitioned to a home-based program . Both groups were then reevaluated at the end of 24 weeks . The initial claudication distance ( ICD ) and absolute claudication distance ( ACD ) on progressive treadmill exercise was measured at baseline , 12 weeks , and 24 weeks . Additionally , self-reported quality of life status was evaluated using the MOS SF-36 question naire . RESULTS Each group improved ( P ACD from baseline to 12 weeks , which was sustained at the 24-week follow-up . Both groups experienced similar long-term improvements ( P ACD ( 521.5 + /- 253.4 meters to 741.9 + /- 365.6 meters for the supervised group , 532.2 + /- 263.5 meters to 715.0 + /- 394.4 meters in the home group , P not significant , between groups ) . The supervised group experienced a greater improvement ( P ICD after 12 weeks than the home group but not at 24 weeks . The on-site group also experienced significant improvements in ICD after 24 weeks ( P self-reported physical function or mental health as assessed by the MOS SF-36 . CONCLUSION A structured exercise program was more effective in improving the ICD over a 24-week period than a less formal , home-based program . However , if patients are screened properly and receive adequate instruction , a home-based program can be a safe , low-cost alternative providing similar long-term ( 24 weeks ) exercise benefits in ACD",
"OBJECTIVES to compare the effect of surgery , exercise and simple observation on maximum exercise power in claudicants . DESIGN prospect i ve , r and omised study . METHODS a total of 264 unselected claudicants were r and omised to supervised exercise training , invasive treatment ( open surgical or endovascular procedures ) or observation . One year treatment outcomes were analysed on an intention to-treat basis . RESULTS invasively treated patients showed a significant improvement in maximum walking power , stopping distance , post-ischaemic blood flow and big toe pressure at one year . Patients r and omised to physical exercise training or to the control group did not improve in any outcome measure . CONCLUSION invasive treatment increased walking capacity , leg blood pressure and flow . Supervised physical exercise training offered no therapeutic advantage compared to untreated controls",
"BACKGROUND Supervised exercise training ( SET ) is recommended as initial treatment to improve walking capacity in peripheral arterial disease ( PAD ) patients with intermittent claudication . Various mechanisms by which SET yields beneficial effects are postulated , however data regarding its influence on angiogenesis are scarce . Thus , we design ed a prospect i ve r and omized controlled trial to study the impact of SET on markers of angiogenesis and endothelial function in PAD . METHODS Forty PAD patients were r and omized to SET on top of best medical treatment ( SET+BMT ) for 6 months versus best medical treatment ( BMT ) only . Endothelial progenitor cells ( EPC ) were assessed by whole-blood flow cytometry ( co-expression of CD34 + CD133 + KDR+ ) and cell culture assays ( endothelial cell-colony forming units , circulating angiogenic cells , migration assay ) at baseline , 3 , 6 and 12-months after inclusion . Changes of plasma levels of asymmetric dimethylarginine ( ADMA ) , vascular endothelial growth factor ( VEGF ) , stromal cell-derived factor-1 ( SDF-1 ) and maximum walking distance were determined . RESULTS EPC - measured by flow cytometric and cell culture techniques - increased significantly upon training paralleled by a significant decrease of ADMA when compared to the BMT group ( p beneficial effect of SET on EPC diminished , but maximum walking distance was significantly improved compared to baseline and controls ( p VEGF and SDF-1 plasma levels in time course . CONCLUSIONS SET increases circulating EPC counts and decreases ADMA levels reflecting enhanced angiogenesis and improved endothelial function , which might contribute to cardiovascular risk reduction",
"BACKGROUND Exercise training reduces walking disability in peripheral arterial disease ( PAD ) . This non-r and omized study evaluates the effects on walking ability and hemodynamic parameters of a novel approach to home-based rehabilitation , the test in -train out program ( Ti-To ) , compared with the traditional home-based free walking exercise ( Tr-E ) . METHODS AND RESULTS A total of 143 patients with claudication ( 117 men , average age 68+/-10 years ) , were included in a Ti-To ( n=83 ) or Tr-E program ( n=60 ) . Evaluations , which were carried out upon entry and at 1 , 2 , 3 , 4 and 6 months , included : self-reported claudication , walking ability ( ie , absolute claudication distance , pain threshold speed ) , resting/exercise heart rates ( HR ) , systolic/diastolic brachial pressure ( SBP/DBP ) , ankle pressure ( AP ) , ankle-brachial index ( ABI ) . Ti-To involved 2 daily 10-min home walking sessions at maximal asymptomatic speed and the patient attending monthly check-ups at hospital . Tr-E involved 20 - 30 min of daily walking at self-selected speeds up to pain tolerance . A total of 126 patients ( Ti-To , n=74 ; Tr-E , n=52 ) completed the program . Ti-To induced better relief from claudication ( p=0.001 ) . Functional parameters improved significantly for both groups ( p SBP and exercise HR decreased significantly in both groups , with Ti-To improving resting HR ( p=0.0002 ) , DBP ( p=0.003 ) , lowest AP worse limb ( p=0.004 ) and ABI worse limb ( p=0.0002 ) . CONCLUSIONS In patients with PAD , a Ti-To program had more positive effects on perceived claudication , and functional and hemodynamic parameters than did a Tr-E program",
"OBJECTIVE The initial treatment for intermittent claudication is supervised exercise therapy ( SET ) . Owing to limited capacity and patient transports costs of clinic-based SET , a concept of SET provided by local physiotherapists was developed . We hypothesized that provision of daily feedback with an accelerometer in addition to SET would further increase walking distance . METHODS This multicenter r and omized trial was set in vascular surgery outpatient clinics and included 304 patients with intermittent claudication . Patients were r and omized to exercise therapy in the form of \" go home and walk \" advice ( WA ) , SET , or SET with feedback . Local physiotherapists provided SET . The primary outcome measure was the change in absolute claudication distance . Secondary outcomes were the change in functional claudication distance and results on the Walking Impairment Question naire ( WIQ ) and Short-Form 36 ( SF-36 ) Health Survey after 12 months . RESULTS In 11 centers , 102 , 109 , and 93 patients were included , respectively , in the WA , SET , and SET with feedback groups , and data for 83 , 93 , and 76 , respectively , could be analyzed . The median ( interquartile range ) change in walking distance between 12 months and baseline in meters was 110 ( 0 - 300 ) in the WA group , 310 ( 145 - 995 ) in the SET group , and 360 ( 173 - 697 ) in the SET with feedback group ( P WIQ scores and relevant domains of the SF-36 improved statistically significantly in the SET groups . CONCLUSIONS SET is more effective than WA in improving walking distance , WIQ scores , and quality of life for patients with intermittent claudication . Additional feedback with an accelerometer did not result in further improvement . SET programs should be made available for all patients with intermittent claudication",
"OBJECTIVE Physicians and patients consider the limited walking distance and perceived disability when they make decisions regarding ( invasive ) treatment of intermittent claudication ( IC ) . We investigated the relationship between walking distances estimated by the patient , on the corridor and on a treadmill , and the Walking Impairment Question naire ( WIQ ) in patients with IC due to peripheral arterial disease . METHODS This was a single-center , prospect i ve observational cohort study at a vascular laboratory in a university hospital in the Netherl and s. The study consisted of 60 patients ( 41 male ) with a median age of 64 years ( range , 44 - 86 years ) with IC and a walking distance ≤ 250 m on a st and ardized treadmill test . Main outcome measures were differences and Spearman rank correlations between pain-free walking distance , maximum walking distance ( MWD ) estimated by the patient , on the corridor and on a st and ardized treadmill test , and their correlation with the WIQ . RESULTS The median patients ' estimated , corridor , and treadmill MWD were 200 , 200 , and 123 , respectively ( P MWD was moderate ( r = 0.61 ; 95 % confidence interval [ CI ] , 0.42 - 0.75 ) . The correlation between patients ' estimated and treadmill MWD was weak ( r = 0.39 ; 95 % , CI 0.15 - 0.58 ) . Respective correlations for the pain-free walking distance were comparable . The patients ' estimated MWD was moderately correlated with WIQ total score ( r = 0.63 ; 95 % , CI 0.45 - 0.76 ) and strongly correlated with WIQ distance score ( r = 0.81 ; 95 % CI , 0.69 - 0.88 ) . The correlation between the corridor MWD and WIQ distance score was moderate ( r = 0.59 ; 95 % CI , 0.40 - 0.74 ) . CONCLUSIONS Patients ' estimated walking distances and on a treadmill do not reflect walking distances in daily life . Instruments that take into account the perceived walking impairment , such as the WIQ , may help to better guide and evaluate treatment decisions",
"BACKGROUND It is not clear whether subgroups of patients with peripheral artery disease ( PAD ) and claudication respond more favorably to exercise rehabilitation than others . We determined whether sex and diabetes were factors associated with the response to exercise rehabilitation in patients with claudication . METHODS Eighty patients were r and omized to home-based and supervised exercise programs , and 60 finished with complete exercise intervention data . Exercise consisted of intermittent walking to near maximal claudication pain for 3 months . Primary outcome measures included claudication onset time ( COT ) and peak walking time . Patients were partitioned into diabetic and nondiabetic groups and then further partitioned by sex to form four groups . RESULTS Overall , exercise adherence was high ( 84 % ) , and there was no significant difference ( P > .05 ) in the amount of exercise completed among the four groups . All groups had significant improvements ( P COT and peak walking time after exercise rehabilitation , except for diabetic women ( P > .05 ) . Only 37 % of women with diabetes had an increase in COT compared with 100 % of men with diabetes ( P Women with PAD and claudication , particularly those with diabetes , represent a vulnerable subgroup of patients who respond poorly to a program of exercise rehabilitation . Diabetic women with PAD and claudication may need a greater dose of exercise or another intervention separate from or in combination with exercise to elicit improvements in claudication measures that are similar to nondiabetic women and to diabetic and nondiabetic men",
"OBJECTIVE We used outdoor walking distance measured during 40 minutes as \" real-life \" outdoor walking capacity in 49 patients with intermittent claudication ( IC ) . The outdoor walking distance was measured by a global positioning system application for a smartphone . The relationships of self-reported maximum walking distance ( SR-MWD ) , the MWD on a grade d treadmill test , and the 6-minute maximum walk distance ( 6MWD ) vs outdoors walking capacity were investigated . Also studied were the associations of SR-MWD , MWD , and 6MWD with health-related quality of life assessed with the disease-specific instrument the Vascular Quality of Life Question naire ( VascuQoL ) . METHODS In this prospect i ve observational cohort study , 49 IC patients underwent an outdoor walking capacity test for 40 minutes , and MWD and 6MWD were measured . SR-MWD was recorded , and all subjects completed the VascuQoL question naire . Associations between the different walk estimates and outdoor walking capacity and health-related quality of life were investigated by correlation analysis ( Spearman ρ ) . RESULTS Outdoor walking distance during 40 minutes was a median 2495 m ( range , 1110 - 3300 m ) . SR-MWD correlated moderately and MWD correlated strongly to outdoor walking capacity ( r = 0.56 and r = 0.65 ; P the outdoor walking capacity ( r = 0.78 ; P the VascuQoL sum score ( r = 0.53 ; P outdoor walking capacity and health-related quality of life in IC patients . Our data support the use of 6MWD for routine clinical evaluation of walking capacity in IC patients"
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AIM The first aim of this study was to systematic ally review and critically assess manually controlled instrumented spasticity assessment methods that combine multidimensional signals . The second aim was to extract a set of quantified parameters that are psychometrically sound to assess spasticity in a clinical setting . METHOD Electronic data bases were search ed to identify studies that assessed spasticity by simultaneously collecting electrophysiological and biomechanical signals during manually controlled passive muscle stretches . Two independent review ers critically assessed the method ological quality of the psychometric properties of the included studies using the COSMIN guidelines . RESULTS Fifteen studies with instrumented spasticity assessment s met all inclusion criteria . Parameters that integrated electrophysiological signals with joint movement characteristics were best able to quantify spasticity . There were conflicting results regarding biomechanical-based parameters that quantify the resistance to passive stretch . Few methods have been assessed for all psychometric properties . In particular , further information on absolute reliability and responsiveness for more muscles is needed . INTERPRETATION Further research is required to determine the correct parameters for quantifying spasticity based on integration of signals , which especially focuses on distinguishing the neural from non-neural contributions to increased joint torque . These parameters should undergo more rigorous exploration to establish their psychometric properties for use in a clinical environment | [
"Background Spasticity is a common impairment that follows stroke , and it results typically in functional loss . For this reason , accurate quantification of spasticity has both diagnostic and therapeutic significance . The most widely used clinical assessment of spasticity is the modified Ashworth scale ( MAS ) , an ordinal scale , but its validity , reliability and sensitivity have often been challenged . The present study addresses this deficit by examining whether quantitative measures of neural and muscular components of spasticity are valid , and whether they are strongly correlated with the MAS . Methods We applied abrupt small amplitude joint stretches and Pseudor and om Binary Sequence ( PRBS ) perturbations to both paretic and non-paretic elbow and ankle joints of stroke survivors . Using advanced system identification techniques , we quantified the dynamic stiffness of these joints , and separated its muscular ( intrinsic ) and reflex components . The correlations between these quantitative measures and the MAS were investigated . Results We showed that our system identification technique is valid in characterizing the intrinsic and reflex stiffness and predicting the overall net torque . Conversely , our results reveal that there is no significant correlation between muscular and reflex torque/stiffness and the MAS magnitude . We also demonstrate that the slope and intercept of reflex and intrinsic stiffnesses plotted against the joint angle are not correlated with the MAS . Conclusion Lack of significant correlation between our quantitative measures of stroke effects on spastic joints and the clinical assessment of muscle tone , as reflected in the MAS suggests that the MAS does not provide reliable information about the origins of the torque change associated with spasticity , or about its contributing components",
"The objective of this study is to develop a portable device for quantifying the velocity-dependent properties of spastic elbow muscles . Based on a motor-driven system , validation tests of the portable system such as accuracy and response of sensors were first examined . Furthermore , simulated modules ( inertia , damper and spring ) as well as elbow joints ( 15 control and 15 hemiplegic subjects ) were manually stretched under four different frequencies ( 1/3 , 1/2 , 1 and 3/2 Hz ) through 60 degrees range of motion . Joint resistance and displacement during sinusoidal stretch were collected for further analysis . Two quantitative parameters ( i.e. , viscous components under each frequency and averaged viscosity across four frequencies ) were derived to estimate the velocity-dependent properties of elbow joint . Tests of simulated modules confirm the manual stretch protocol and data analysis are valid in estimating the velocity-dependent component during a sinusoidal stretch . Compared to normal control , viscous component in each stretch frequency and averaged viscosity were significantly higher in subjects with spasticity ( P viscous component and averaged viscosity were found highly correlated with the modified Ashworth scale . These findings suggest that measurements of viscous component and averaged viscosity during manual sinusoidal stretching using the portable device could be clinical ly useful in evaluating spasticity",
"OBJECTIVE To establish reliability of quantitative measures of elbow joint spastic hypertonia in post-stroke hemiparesis . METHODS Nine subjects with post-stroke hemiparesis ( mn duration : 42 months ) were tested on three separate days . Biceps brachii and brachioradialis EMG were recorded during passive ramp- and -hold extensions applied at seven speeds between 30 and 210 degrees /s . EMG burst duration , onset position threshold , and burst intensity were used to evaluate reflex activity . Torque at 40 degrees of elbow flexion was used as a mechanical indicator of spastic hypertonia . RESULTS Across speeds ICCs were consistent , means ranged between 0.63 and 0.85 . Thus , relative reliability was fair to excellent for all parameters . Absolute reliability , determined using st and ard error of measurement expressed as a percentage of the mean score ( % SEM ) , improved at higher speeds ( > or = 120 degrees/s ) . CONCLUSIONS These results establish reliability of reflex and mechanical measures of elbow spastic hypertonia post-stroke . The data demonstrate greater reflex detection at high speeds , indicating greater potential to document meaningful changes in these distinct aspects of spastic hypertonia following intervention . SIGNIFICANCE Based on findings of this study , reliability was demonstrated using four parameters of reflex EMG and torque indicating measurement consistency across sessions . These observations motivate determination of requisite effect sizes for clinical trials that evaluate treatment outcome",
"OBJECTIVE The purpose of this study was first to compare the kinematic parameters of imposed ankle mobilizations measured during Ashworth or isokinetic tests and , second , to better underst and why the stretch reflex was more or less easily elicited by one method or the other . METHODS Passive dorsiflexions were applied on eight adult patients with plantarflexor spasticity in two conditions : ( i ) manually , using the Ashworth test where passive dorsiflexions were performed freely by seven rehabilitation clinicians , and ( ii ) instrumentally , using an isokinetic device ( Cybex Norm ) and a dorsiflexion velocity at 300 degrees /s . Mean values of initial ankle position , maximal angular velocity ( theta;'(max ) ) , maximal angular acceleration ( theta;''(max ) ) and plantarflexor reflex responses obtained with each method were compared . RESULTS During the Ashworth test , all the patients presented reflex activities in the triceps surae while , during the isokinetic mobilization , only three out of the eight patients tested shown reflex responses . theta;'(max ) values were significantly higher ( P theta;''(max ) values ( 5046+/-2181 degrees /s(2 ) for the Ashworth test vs 819+/-18 degrees /s(2 ) for the isokinetic test , P mean rms-EMG values of the gastrocnemius lateralis ( GL ) and the soleus ( SOL ) . CONCLUSIONS This study indicates that passive dorsiflexions imposed during Ashworth and isokinetic tests largely differ in velocity and acceleration , and the higher dynamic parameters evaluated during the Ashworth test could mainly explain that the stretch reflex was more easily elicited during this manual testing . SIGNIFICANCE If isokinetic devices offer numerous advantages in the assessment of passive resistance to spastic muscle stretch , they can not be used to simulate the manual test",
"The tonic stretch reflex threshold in children with cerebral palsy ( CP ) was measured to determine its test-retest reliability and its concurrent validity as a potential measure of spasticity . Fourteen children with spastic CP aged 6 to 18 years were tested on three separate occasions for clinical spasticity and stretch reflex thresholds of affected elbow flexors . Electromyographic ( EMG ) recordings were obtained by surface electrodes for elbow flexors and extensors during mechanical displacements of the passive joint towards extension . Displacements were produced by a torque motor at seven velocities which r and omly varied from trial to trial . EMG activity was measured in the stretched flexor muscles to determine threshold angles and velocities for each velocity of stretch . These were plotted on a velocity-angle-phase diagram and regression analysis was used to determine the static stretch reflex threshold for each participant . The measure showed good test-retest reliability for the group ( ICC 0.73 , p clinical spasticity scale was not found . This technique is a potential outcome variable for measuring the efficacy of treatments aim ed at decreasing spasticity in children with CP",
"Precise detection of discrete motor events like the onsets of voluntary muscle contractions is a prerequisite for various psychophysiological approaches in sensorimotor system analysis . In biomedical research and clinical diagnosis , motor events frequently are determined from surface electromyographic ( SEMG ) signals by some computerized detection algorithm . However , little is known about the reliability and accuracy of these methods , which frequently rely on intuitive and heuristic criteria . Therefore , the systematic approach to computerized detection of discrete motor events from SEMG signals presented by this paper fills a basic gap in EMG signal processing . Based upon a dynamic process model for the SEMG signal , a formal detection scheme is established which incorporates the essential processing modules common to the majority of algorithms . In addition , using concepts of statistically optimal change detection in r and om processes , a new model-based algorithm is presented which serves as a reference for optimum performance . The validity of this concept is demonstrated for the specific example of accurate detection of muscle activation onsets in rapid voluntary contractions ; the estimation error ( i.e. , the deviation between estimated and \" true \" onset time ) was evaluated by statistical simulations for three representative methods . Results show a substantial decrease of performance of traditional methods in the case of highly variable dynamic muscle activation profiles and /or superimposed activation patterns ( e.g. , due to a secondary motor task simultaneously executed by the same muscle ) . The model-based approach provided significantly more accurate results , even when the exact model parameters were unknown but estimated from the SEMG signal actually measured . It is concluded that the detection algorithm has to be critically taken into consideration during interpretation of motor events resolved from SEMG signals . The process model together with the corresponding statistically optimal detector represents an efficient tool for selecting appropriate detection algorithms for a particular experimental condition , and it allows a quantitative assessment of their performance",
"BACKGROUND AND PURPOSE In this study , we compared the intertrial reliability of resistive torque measurements obtained with h and -held and isokinetic dynamometers and examined the validity of the h and -held dynamometers for the assessment of spastic hypertonia , defined as reflex- and nonreflex-induced resistance to stretch . SUBJECTS Nine subjects ( mean age = 40.6 years ) with a chronic ( 1 - 5 years ) spinal cord injury participated . METHODS The plantar flexors were stretched at 5 degrees /s ( low velocity [ LV ] ) and 180 degrees /s ( high velocity [ HV ] ) with an isokinetic dynamometer while the evaluator attempted to match these velocities with a h and -held dynamometer . Electromyographic activity of the soleus and tibialis anterior muscles as well as ankle displacements were recorded . Resistive torque and velocity , measured at -5 degrees of dorsiflexion , were averaged ( n = 4 ) . RESULTS High intraclass correlation coefficients ( ICCs ) were found at LV and HV for both the h and -held ( ICC = .93 and .84 ) and isokinetic ( ICC = .99 and .93 ) dynamometers . With the h and -held dynamometer , lower resistive torques were found at LV ( 0.8 N.m ) and HV ( 1.2 N.m ) , whereas higher velocities were attained at HV . CONCLUSION AND DISCUSSION The results indicate that the reproducibility of resistive torques obtained with h and -held dynamometry compares with that obtained with isokinetic dynamometry and allows testing of velocities that can be adjusted to the specific level of resistance to stretch . Electromyography confirmed the validity of h and -held dynamometry for assessing reflex and nonreflex components of SH . [ Lamontagne A , Malouin F , Richards CL , Dumas F. Evaluation of reflex- and nonreflex-induced muscle resistance to stretch in adults with spinal cord injury using h and -held and isokinetic dynamometry",
"Objective : To quantify the clinical efficacy of botulinum toxin type A in treating elbow flexor spasticity in a unilateral stroke population . Location : A spasticity clinic at a regional neurological rehabilitation centre . Study design : A convenience sample longitudinal study . Fourteen subjects with elbow flexor spasticity secondary to a stroke were recruited . Two repeated measures , one before and another four weeks after treatment , were taken to quantify clinical efficacy . Outcome measures : Elbow flexor spasticity was simultaneously rated with the modified Ashworth scale ( MAS ) and quantified by measuring the surface EMG from the flexors using a custom-built device . Strength at the elbow ( isometric ) , grip strength and upper limb function ( Action Research Arm test ) were also assessed . Treatment : Injections of botulinum toxin type A ( Botox ® ) to the m.biceps brachii ( mean dose 70 U ) , m.brachioradialis ( mean dose 56.5 U ) and m.flexor digitorum longus ( mean dose 83.3 U ) . Results : Following treatment , spasticity ( as measured by flexor EMG activity ) reduced but the MAS was unable to detect this improvement . In some subjects , isometric flexor strength at the elbow as well as grip strength increased . This was contrary to the expected weakening following treatment with botulinum toxin type A and suggests an optimization of motor control . Conclusion : Treatment with Botox ® reduces spasticity but does not necessarily cause a reduction in the force generating capabilities at the joint . The improvement in strength may have contributed to the improvements in upper limb function . The MAS is an inappropriate measure of spasticity",
"OBJECTIVE To compare responsiveness and predictive ability of clinical and instrumented spasticity assessment s after botulinum toxin type A ( BTX ) treatment combined with casting in the medial hamstrings ( MEHs ) in children with spastic cerebral palsy ( CP ) . DESIGN Prospect i ve cohort study . SETTING Hospital . PARTICIPANTS Consecutive sample of children ( N=31 ; 40 MEH muscles ) with CP requiring BTX injections . INTERVENTION Clinical and instrumented spasticity assessment s before and on average ± SD 53±14 days after BTX . MAIN OUTCOME MEASURES Clinical spasticity scales included the Modified Ashworth Scale and the Modified Tardieu Scale . The instrumented spasticity assessment integrated biomechanical ( position and torque ) and electrophysiological ( surface electromyography ) signals during manually performed low- and high-velocity passive stretches of the MEHs . Signals were compared between both stretch velocities and were examined pre- and post-BTX . Responsiveness of clinical and instrumented assessment s was compared by percentage exact agreement . Prediction ability was assessed with a logistic regression and the area under the receiver operating characteristic ( ROC ) curves of the baseline parameters of responders versus nonresponders . RESULTS Both clinical and instrumented parameters improved post-BTX ( P≤.005 ) ; however , they showed a low percentage exact agreement . The baseline Modified Tardieu Scale was the only clinical scale predictive for response ( area under the ROC curve=0.7 ) . For the instrumented assessment , baseline values of root mean square ( RMS ) electromyography and torque were better predictors for a positive response ( area under the ROC curve=.82 ) . Baseline RMS electromyography remained an important predictor in the logistic regression . CONCLUSIONS The instrumented spasticity assessment showed higher responsiveness than the clinical scales . The amount of RMS electromyography is considered a promising parameter to predict treatment response",
"In clinical setting s , the spastic catch is judged subjectively . This study assessed the psychometric properties of objective parameters that define and quantify the severity of the spastic catch in children with cerebral palsy ( CP ) . A convenience sample of children with spastic CP ( N=46 ; age range : 4 - 16 years ) underwent objective spasticity assessment s. High velocity , passive stretches were applied to the gastrocnemius ( GAS ) and medial hamstrings ( MEH ) . Muscle activity was measured with surface electromyography ( sEMG ) , joint angle characteristics using inertial sensors and reactive torque using a force sensor . To test reliability , a group of 12 children were retested after an average of 13 ± 9 days . The angle of spastic catch ( AOC ) was estimated by three biomechanical definitions : joint angle at ( 1 ) maximum angular deceleration ; ( 2 ) maximum change in torque ; and ( 3 ) minimum power . Each definition was checked for reliability and validity . Construct and clinical validity were evaluated by correlating each AOC definition to the averaged root mean square envelope of EMG ( RMS-EMG ) and the Modified Tardieu Scale ( MTS ) . Severity categories were created based on selected parameters to establish face validity . All definitions showed moderate to high reliability . Significant correlations were found between AOC3 and the MTS of both muscles and the RMS-EMG of the MEH , though coefficients were only weak . AOC3 further distinguished between mild , moderate and severe catches . Objective parameters can define and quantify the severity of the spastic catch in children with CP . However , a comprehensive underst and ing requires the integration of both biomechanical and RMS-EMG data"
] | 411634ae-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Conventional total knee arthroplasty ( TKA ) and the more recently available computer-navigated total knee arthroplasty ( CNTKA ) use alternative methods to achieve correct limb alignment . This systematic review was undertaken to assess the safety and effectiveness of CNTKA compared with conventional TKA . METHODS A systematic search of multiple data bases identified relevant r and omized controlled trials published to August 2012 . Study inclusion was established through application of a predetermined protocol , with independent assessment by two review ers . RESULTS Thirty r and omized controlled trials were included . The majority of adverse events associated with CNTKA were minor and comparable with those seen with conventional TKA . Conversion to conventional TKA was required in 1 % of patients undergoing CNTKA . Thirteen trials reporting on satisfactory post-operative radiological alignment of the mechanical axis in the frontal plane were suitable for meta- analysis , which showed a significant total odds ratio ( non-event ) of 2.32 ( 95 % confidence interval : 1.77 - 3.04 ) in favour of CNTKA ( P Clinical outcomes were comparable between the two techniques , with longer-term follow-up suggesting that CNTKA provided no benefit over conventional TKA in terms of sustained functional improvements . CONCLUSIONS At present , it is unclear whether the significant improvements shown in radiological outcomes after CNTKA translate to measurable clinical benefits . Although an assumption could be made that an improvement in post-operative alignment should lead to an improvement in patient-related outcomes , the available literature did not clearly show this . Further , long-term trials are required to address this issue | [
"BACKGROUND Optimal alignment of the prosthesis in total knee arthroplasty results in improved patient outcomes . The goal of this study was to determine the most accurate technique for component alignment in total knee arthroplasty by comparing computer-assisted surgery with two conventional techniques involving use of an intramedullary guide for the femur and either an intramedullary or an extramedullary guide for the tibia . METHODS One hundred and seven patients were r and omized prior to surgery to one of three arms : computer-assisted surgery for both the femur and the tibia ( the computer-assisted surgery group ) , intramedullary guides for both the femur and the tibia ( the intramedullary guide group ) , and an intramedullary guide for the femur and an extramedullary guide for the tibia ( the extramedullary guide group ) . Measurements of alignment on hip-to-ankle radiographs and computed tomography ( CT ) scans made three months after surgery were evaluated . The operative times and complications were compared among the three groups . RESULTS The coronal tibiofemoral angle demonstrated , on average , less malalignment in the computer-assisted surgery group ( 1.91 ° ) than in the extramedullary ( 3.22 ° ) and intramedullary ( 2.59 ° ) groups ( p = 0.007 ) . The coronal tibiofemoral angle was > 3 ° of varus or valgus deviation in 19 % ( seven ) of the thirty-six patients treated with computer-assisted surgery compared with 38 % ( thirteen ) of the thirty-four in the extramedullary guide group and 36 % ( thirteen ) of the thirty-six in the intramedullary guide group ( p = 0.022 ) . The increase in accuracy with computer-assisted surgery came at a cost of increased operative time . The operative time for the computer-assisted surgery group averaged 107 minutes compared with eighty-three and eighty minutes , respectively , for the surgery with the extramedullary and intramedullary guides ( p implant alignment with computer-assisted total knee arthroplasty , as measured with radiography and computed tomography , is significantly improved compared with that associated with conventional surgery with intramedullary or extramedullary guides . This finding adds to the body of evidence showing an improved radiographic outcome with computer-assisted surgery compared with that following conventional total knee arthroplasty",
"BACKGROUND Total knee arthroplasty has been increasingly used for young and active patients , and prosthesis durability is important in these patients . The accuracy of implant placement has been one of the major factors that determine the long-term survival of the prosthesis . The purpose of this study was to compare the accuracy of prosthetic alignment between computer-assisted-navigation and conventional total knee arthroplasties . METHODS From March 2007 to June 2008 , thirty-two patients with bilateral knee osteoarthritis underwent simultaneous bilateral total knee arthroplasty with the same type of implant in each knee . The subjects included seven men and twenty-five women , with an average age of sixty-three years . For each patient , the bilateral total knee arthroplasty was performed with computer-assisted navigation in one knee and a conventional technique in the other . The operative technique and the order of the surgical procedures were r and omized . The patients and surgeons conducting the follow-up study and performing the imaging measurements were blinded to the type of surgical procedure . RESULTS There was a significant difference between the two groups with regard to the alignment of the knee prosthesis in the coronal and sagittal planes . Nine knee implants ( 28 % ) in the conventional group , compared with no knee implants in the computer-navigation group , deviated > 3 ° from the mechanical axis in the coronal plane . The coefficient variation of data in the conventional group was three times greater than that in the computer-navigation group . There was no significant difference in the rotational angle of the femoral component between the two groups . The Hospital for Special Surgery ( HSS ) scores at six months postoperatively were substantially increased compared with the preoperative scores in both groups . CONCLUSIONS Computer-assisted navigation consistently provided coronal plane alignment within 3 ° of the mechanical axis , which was significantly better than the alignment obtained with conventional total knee arthroplasty",
"A number of studies have reported a significant improvement of the postoperative alignment , when computer-navigated total knee arthroplasty ( TKA ) was compared with conventional techniques . However , no studies are available on the functional and patient-relevant outcomes after computer-assisted knee replacement . In a prospect i ve , r and omized trial comparing 27 computer-assisted TKAs with 25 conventional implantations , the Knee Society Score was used to assess functional status , and the WOMAC question naire was used to record the disease-specific , patient-relevant outcome . At a twelve-month follow-up no significant difference was detected between the two patient groups in either the scores or the number of complications and range of postoperative knee flexion . The results are in agreement with those reported in other studies on the effect of conventional TKA . With the patient group of this size it can be concluded that computer-navigated TKA gives short-term resuits comparable with those achieved by conventional methods of implantation",
"In this prospect i ve , r and omized , controlled study , we compared the performance of conventional and navigated total knee arthroplasties . Component alignment was measured in 60 patients operated on using navigation and in 60 patients operated on using the conventional technique . The groups then were divided into a sub population to measure alignments of the distal femoral cuts in the three anatomic planes , the proximal tibial cut in the frontal and sagittal planes , and the result ing lower limb mechanical axis in the frontal plane . Postoperative weightbearing long-view radiographs were evaluated as were clinical results using three st and ard question naires at 28 months followup . The intraoperative measurements ( mean ± st and ard deviation ) at the resection planes showed navigated surgeries result in more accurate alignments than conventional surgeries for the femur : in the frontal plane , 0.1 ° ± 0.9 ° and 0.7 ° ± 1.6 ° valgus , respectively ; in the sagittal plane , 1.1 ° ± 1.8 ° and 2.8 ° ± 2.0 ° flexion ; and in the transversal plane , 0.1 ° ± 1.2 ° and 0.9 ° ± 1.7 ° internal rotation . The navigated technique also reduced the number of cases with final mechanical axes greater than 3 ° from 20.0 % to 1.7 % . Postoperative radiographs showed better component alignment using navigation , particularly at the femur . However , clinical scoring systems showed this radiographic improvement did not necessarily result in a better clinical outcome at short-term followup . Level of Evidence : Level I , therapeutic study . See the Guidelines for Authors for a complete description of level of evidence",
"To compare the alignment after computer-navigated total knee arthroplasty , 52 patients were r and omly allocated to 2 groups . Twenty-seven patients received a total knee arthroplasty with the aid of a kinematic computer-navigation system , and 25 patients received a total knee arthroplasty with the conventional method . Both groups were well balanced concerning demographic data and preoperative scores . At 3-month follow-up , the mechanical alignment of the leg reached the desired straight axis in more cases with the computer-navigated implantation . This difference was statistically significant . The femoral and tibial mechanical anteroposterior axis and the femoral and tibial sagittal tilt ( slope ) measured on sagittal x-rays were not significantly improved in this patient group",
"Purpose . To assess early postoperative rehabilitation outcome following computer-assisted total knee arthroplasty ( TKA ) or st and ard instrumentation TKA using a medial parapatellar or subvastus approach . Methods . A prospect i ve controlled trial of 70 consecutive patients undergoing TKA with a low contact stress rotating platform prosthesis was conducted . Patients were r and omised to receive surgery with either computer navigation or st and ard instrumentation . A medial parapatellar or subvastus approach was used according to the surgeons ' preference . Outcome measures included preoperative knee function , intra-operative factors , and postoperative rehabilitation . Results . Duration of surgery was significantly longer when using computer navigation ; however , operating time decreased with greater experience . A higher incidence and duration of early postoperative quadriceps dysfunction was associated with computer-assisted TKA through the medial parapatellar approach than through the subvastus approach or TKA performed with st and ard instrumentation . No patient who received surgery through the subvastus approach had a lag of more than 20 degrees , at 48 hours postoperatively , regardless of the instrumentation used . Conclusion . Computer-assisted TKA through a medial parapatellar approach was associated with delayed recovery of the quadriceps during early postoperative rehabilitation . This was due to the additional quadriceps dissection required to place the femoral tracking array . The subvastus approach is therefore recommended for computer-assisted TKA",
"We undertook a prospect i ve , r and omised study using a non-invasive transcranial Doppler device to evaluate cranial embolisation in computer-assisted navigated total knee arthroplasty ( n = 14 ) and compared this with a st and ard conventional surgical technique using intramedullary alignment guides ( n = 10 ) . All patients were selected r and omly without the knowledge of the patient , anaesthetists ( before the onset of the procedure ) and ward staff . The operations were performed by a single surgeon at one hospital using a uniform surgical approach , instrumentation , technique and release sequence . The only variable in the two groups of patients was the use of single tracker pins of the imageless navigation system in the tibia and femur of the navigated group and intramedullary femoral and tibial alignment jigs in the non-navigated group . Acetabular Doppler signals were obtained in 14 patients in the computer-assisted group and nine ( 90 % ) in the conventional group , in whom high-intensity signals were detected in seven computer-assisted patients ( 50 % ) and in all of the non-navigated patients . In the computer-assisted group no patient had more than two detectable emboli , with a mean of 0.64 ( SD 0.74 ) . In the non-navigated group the number of emboli ranged from one to 43 and six patients had more than two detectable emboli , with a mean of 10.7 ( sd 13.5 ) . The difference between the two groups was highly significant using the Wilcoxon non-parametric test ( p = 0.0003).Our findings show that computer-assisted total knee arthroplasty , when compared with conventional jig-based surgery , significantly reduces systemic emboli as detected by transcranial Doppler ultrasonography",
"Systemic emboli released during total knee replacement have been implicated as a cause of peri-operative morbidity and neurological dysfunction . We undertook a prospect i ve , double-blind , r and omised study to compare the cardiac embolic load sustained during computer-assisted and conventional , intramedullary-aligned , total knee replacement , as measured by transoesophageal echocardiography . There were 26 consecutive procedures performed by a single surgeon at a single hospital . The embolic load was scored using the modified Mayo grading system for echogenic emboli . Fourteen patients undergoing computer-assisted total knee replacement had a mean embolic score of 4.89 ( 3 to 7 ) and 12 undergoing conventional total knee replacement had a mean embolic score of 6.15 ( 4 to 8) on release of the tourniquet . Comparison of the groups using a two-tailed t-test confirmed a highly significant difference ( p = 0.004 ) . This study demonstrates that computer-assisted knee replacement results in the release of significantly fewer systemic emboli than the conventional procedure using intramedullary alignment",
" After obtaining informed consent , 80 patients were r and omised to undergo a navigated or conventional total knee replacement . All received a cemented , unconstrained , cruciate-retaining implant with a rotating platform . Full-length st and ing and lateral radiographs and CT scans of the hip , knee and ankle joint were carried out five to seven days after operation . No notable differences were found between computer-assisted navigation and conventional implantation techniques as regards the rotational alignment of the femoral or tibial components . Although the deviation from the transepicondylar axis was relatively low , there was a considerable range of deviation for the tibial rotational alignment . There was no statistically significant difference regarding the occurrence pattern of outliers in mechanical malalignment but the number of outliers was reduced in the navigated group",
"Several choices of instrument systems are available for minimally invasive surgical approaches . There are reports that one alternative , the quadriceps sparing , side-cutting instrumentation , results in diminished implantation accuracy . A total of 108 patients were r and omized to undergo TKA either using side-cutting implant instrumentation ( Group A ) or anterior – posterior mini-incision instrumentation ( Group B ) . All TKAs were operated on with a minimal invasive , mini-midvastus surgical approach . 50 % of the TKAs were performed with computer-assistance in each cohort . The radiographic parameters , clinical outcomes and knee scores were evaluated preoperatively and 3 months postoperative . In Group B , we found significantly higher accuracy for the mechanical axis of the limb ( range ±3 ° : Group A 54 % versus Group B 89 % , p = 0.001 ) , medial proximal tibial angle ( range ±3 ° : Group A 85 % versus Group B 98 % , p = 0.027 ) and tibial slope ( range ±3 ° : Group A 59 % versus Group B 85 % , p = 3 ° ) in Group B. Clinical outcomes and knee scores were similar in both groups and were not influenced by computer-assistance . Using the anterior – posterior , mini-incision instruments for minimally invasive TKA will lead to higher implantation accuracy when compared to the quadriceps sparing side-cutting instrumentation . The navigation technique could not compensate for shortcomings of the side-cutting instrumentation . The clinical relevance of this study is that the quadriceps sparing side-cutting instrumentation should not be used for TKA because of unacceptable reduced implantation accuracy ",
"We have compared a new technique of computer-assisted knee arthroplasty with the current conventional jig-based technique in 70 patients r and omly allocated to receive either of the methods . Post-operative CT was performed according to the Perth CT Knee Arthroplasty protocol and pre- and post-operative Maquet views of the limb were taken . Intra-operative and peri-operative morbidity data were collected and blood loss measured . Post-operative CT showed a significant improvement in the alignment of the components using computer-assisted surgery in regard to femoral varus/valgus ( p = 0.032 ) , femoral rotation ( p = 0.001 ) , tibial varus/valgus ( p = 0.047 ) tibial posterior slope ( p = 0.0001 ) , tibial rotation ( p = 0.011 ) and femorotibial mismatch ( p = 0.037 ) . St and ing alignment was also improved ( p = 0.004 ) and blood loss was less ( p = 0.0001 ) . Computer-assisted surgery took longer with a mean increase of 13 minutes ( p = 0.0001 )",
"We carried out a prospect i ve r and omised study to evaluate the blood loss in 60 patients having a total knee arthroplasty and divided r and omly into two equal groups , one having a computer-assisted procedure and the other a st and ard operation . The surgery was carried out by a single surgeon at one institution using a uniform approach . The only variable in the groups was the use of intramedullary femoral and tibial alignment jigs in the st and ard group and single tracker pins of the imageless navigation system in the tibia and femur in the navigated group . The mean drainage of blood was 1351 ml ( 715 to 2890 ; 95 % confidence interval ( CI ) 1183 to 1518 ) in the computer-aided group and 1747 ml ( 1100 to 3030 ; CI 1581 to 1912 ) in the conventional group . This difference was statistically significant ( p = 0.001 ) . The mean calculated loss of haemoglobin was 36 g/dl in the navigated group versus 53 g/dl in the conventional group ; this was significant at p reduction in blood drainage and the calculated Hb loss between the computer-assisted and the conventional techniques . This allows the ordering of less blood before the operation , reduces risks at transfusion and gives financial saving . Computer-assisted surgery may also be useful for patients in whom blood products are not acceptable ",
"Computer-assisted surgery ( CAS ) in total knee arthroplasty ( TKA ) could be useful in reducing the overall blood loss . A prospect i ve r and omised study was performed with two groups of 50 patients each of whom were treated for knee arthritis . Patients of group A were treated by a conventional st and ard procedure , while for patients of group B a specific CAS procedure was used . We determined the intraoperative blood loss according to the Orthopaedic Surgery Transfusion Haemoglobin European Overview ( OSTHEO ) study . The average blood loss in patients of group A was 1,974 ml ( range : 450–3,930 ml ) compared to 1,677 ml of patients of group B ( range : 500–2,634 ml ) . A statistically significant difference was found between the two groups ( p = 0.0283 ) . Computer-assisted surgery is highly recommended in TKR to save blood . It creates more possibilities to operate on anaemic patients and subjects who can not accept blood products by reducing blood loss risk . RésuméLa chirurgie assistée par ordinateur dans les prothèses totales du genou peut être utile afin de réduire les pertes sanguines . Matériel et méthode : une étude prospect i ve , r and omisée , a été réalisée avec deux groupes de 50 patients , chacun , traités pour une arthrose du genou . Les patients du groupe A ont été opérés sur un mode conventionnel alors que l’autre groupe l’a été avec assistance informatique dans le cadre de la navigation . Nous avons déterminé les perte sanguines per-opératoires selon l’évaluation OSTEO . Résultats : le total des pertes sanguines du groupe A a été de 1974 ml en moyenne ( de 450 à 3930 ) en comparaison des 1677 ml des patients du groupe B ( de 500 à 2634 ml ) . La différence est statistiquement significative entre les deux groupes , p = 0,0283 ) . Conclusion : la navigation avec chirurgie assistée par ordinateur est recomm and ée pour les prothèses de remplacement articulaire afin de réduire les pertes sanguines . Cette technique donne plus de possibilité pour opérer les sujets anémiques qui ne peuvent supporter de grosses pertes sanguines",
"Despite the frequent use of computer-assisted total knee arthroplasty ( TKA ) and better radiological results for coronal alignment reported in many studies , there is still no evidence of improved clinical outcomes when compared to conventional TKA . We compared alignment after navigated TKA and conventional TKA in 80 r and omized patients . Seventy three patients were available for physical and radiological examination at 20 month after surgery . Both groups showed similar Knee Society Score results , with medians of 89 points ( navigated 49–95 points , conventional 48–95 points , n.s . ) in the Knee Score and 70 points ( navigated 45–100 points , conventional 40–100 points , n.s . ) in the Function Score . The median improvement in the Knee Society Knee Score was 45 points ( −3 to 88 points ) in the navigated group and 35 points ( −13 to 62 points ) in the conventional group ( P = 0.03 ) , and the Knee Society Function Score improvement was 15 points ( −10 to 50 points ) in the navigated group versus 10 points ( −10 to 50 points ) in the conventional group ( n.s . ) . The current health state at follow-up using the EuroQuol question naire was similar in both groups , with medians of 67 points in the navigated group and 65 points in the conventional group . This investigation did show slightly greater functional improvement at short-term follow-up in the navigated TKA group . Longer follow-up will be required to assess the possible benefit of computer-assisted navigation ",
"The aim of this study was to compare blood loss and transfusion requirements in patients undergoing computer-assisted total knee arthroplasty ( TKA ) and patients operated with conventional instrumentation with intra-medullar guides . A prospect i ve r and omized study of 87 patients undergoing a TKA assigned to conventional technique ( n = 44 ) or computer-assisted surgery ( n = 43 ) was conducted . All patients were operated by the same surgeon and in all cases a cemented arthroplasty and deep recovery drainage were used . Both groups were comparable in all variables except for duration of ischemia , which was 13.7 min higher in the computer-assisted group . Blood loss due to drainage was higher in the conventional technique group ( 613 vs. 447 ml ) , as was the number of patients in which blood from the blood recovery system was reinfused ( 53 vs. 23 % ) . Those patients undergoing computer-assisted surgery experienced less bleeding than those operated with the conventional technique . However , hemoglobin drop and allogenic transfusion rate were not statistically different in both groups",
"The purpose of this study was to evaluate the use of a navigation device in a cohort of 42 total knee arthroplasties ( TKA ) . The patients were r and omised into two groups . Total knee arthroplasties performed using the conventional technique formed the control group ( 21 knees ) ; the experimental group included 21 knees performed with the aid of a computed navigation system . Postoperative mean values for the various measurements showed no significant difference in component alignment . However , the range of individual measurements for coronal and sagittal plane positioning was smaller in the navigated group , in which there were no outliers . Rotational alignment was not different between the two groups . This confirms the advantages and limitations of navigated TKA presented in larger studies",
"We previously compared the component alignment in total knee replacement using a computer-navigated technique with a conventional jig-based method . We r and omly allocated 71 patients to undergo either computer-navigated or conventional replacement . An improved alignment was seen in the computer-navigated group . The patients were then followed up post-operatively for two years , using the Knee Society score , the Short Form-36 health survey , the Western Ontario and McMaster Universities osteoarthritis index , the Bartlett Patellar pain question naire and the Oxford knee score , to assess functional outcome . At two years post-operatively 60 patients were available for assessment , 30 in each group and 62 patients completed a postal survey . No patient in either group had undergone revision . All variables were analysed for differences between the groups either by Student 's t-test or the Mann-Whitney U test . Differences between the two groups did not reach significance for any of the outcome measures at any time point . At two years postoperatively , the frequency of mild to severe anterior pain was not significantly different ( p = 0.818 ) , varying between 44 % ( 14 ) for the computer-navigated group , and 47 % ( 14 ) for the conventionally-replaced group . The Bartlett Patellar score and the Oxford knee score were also not significantly different ( t-test p = 0.161 and p = 0.607 , respectively ) . The clinical outcome of the patients with a computer-navigated knee replacement appears to be no different to that of a more conventional jig-based technique at two years post-operatively , despite the better alignment achieved with computer-navigated surgery",
"In a prospect i ve r and omized control trial comparing computer-assisted vs conventional total knee arthroplasty , we previously reported that patients with coronal alignment within 3 ° of neutral had superior international knee society and Short-Form 12 ( SF-12 ) physical scores at 6 weeks , 3 months , 6 months , and 12 months after surgery . Computer-assisted total knee arthroplasty achieved greater accuracy in implant alignment , and this correlated with better knee function and quality of life . At 5 years , 90 of 111 patients assessed in our original study were review ed . Coronal alignment within 3 ° of neutral continued to be correlated with superior International Knee Society and SF-12 scores . Coronal alignment greater than 3 ° was associated with a significant decline in SF-12 mental health scores",
" Seventy-one patients were r and omly allocated to undergo either computer-navigated or conventional arthroplasty . A statistically significant improvement in alignment was seen in the computer-navigated cohort . Five-year functional outcome was assessed using the Knee Society , Short Form-36 , Western Ontario and McMaster Universities Osteoarthritis Index , and a patient satisfaction score . At 5 years , 46 patients were available for assessment ( 24 navigated and 22 conventional knees ) . No patients had undergone revision . No statistically significant difference was seen in any component of any measure of outcome between navigated and conventional cohorts . Longitudinal data showed function to be well maintained with no difference in functional score between 2 and 5 years in either cohort . Despite achieving better alignment , 5 years postoperatively , the functional outcome with computer-navigated knee arthroplasty appears to be no different to that implanted using a conventional jig-based technique",
"Successful total knee arthroplasty is dependent on the correct alignment of implanted prostheses . Major clinical problems can be related to poor femoral component positioning , including sagittal plane and rotational malalignment . A prospect i ve r and omized study was design ed to test whether an optical navigation system for total knee arthroplasty achieved greater implantation precision than a nonnavigated technique . The primary variable was rotation of the femoral component in the transverse plane , measured from postoperative radiographs and computed tomography images . Sixty-four patients were included in the study . All patients received the Duracon total knee prosthesis . The patients were r and omly divided into two groups : Group C patients had conventional total knee arthroplasty without navigation ; Group N patients had total knee arthroplasty using a computer-assisted knee navigation system . Analysis showed that patients in Group N had significantly better rotational alignment and flexion angle of the femoral component than patients in Group C. In addition , superior postoperative alignment of the mechanical axis , posterior tibial slope , and rotational alignment was achieved for patients in Group N. The use of a navigation system provides improved alignment accuracy , and can help to avoid femoral malrotation and errors in axial alignment",
"The aim of this study is to assess the radiological outcome of conventional techniques versus computer-navigated surgery for total knee arthroplasty . Ninety patients with knee arthritis were prospect ively r and omized into 3 groups : conventional technique : extramedullary ( EM ) and intramedullary ( IM ) tibia guide versus computer navigation surgery ( CAS ) . Two surgeons performed all procedures . St and ardized long leg coronal and sagittal x-rays were evaluated by a blinded assessor . Our results showed that CAS had greater consistency and accuracy in implant placement . In the coronal view , 93.3 % in the CAS group had better outcomes compared with EM ( 73.4 % ) and IM ( 60.0 % ) . In the sagittal axis , 90.0 % CAS also had better outcomes compared with EM ( 63.3 % ) and IM ( 76.7 % ) . Computer-navigated total knee arthroplasty helps increase accuracy and reduce \" outliers \" for implant placement",
"A prospect i ve exploratory study of fat emboli in patients undergoing total knee arthroplasty was performed in patients r and omly assigned to surgery with computer-assisted navigation or st and ard technique . Transesophageal echocardiography of the right atrium was recorded for 5 consecutive 1-minute intervals after tourniquet deflation . Emboli were grade d on a scale of 0 to 3 based on embolism size , amount of atrium filled , and duration of embolic shower , creating an overall score of 0 to 9 . The mean ( SD , range ) of the 5 overall scores for each total knee arthroplasty was 6.00 ( 0.76 , 4.6 - 7.4 ) for computer-assisted navigation ( 22 patients ) and 6.42 ( 0.97 , 4.6 - 7.9 ) for st and ard technique ( 22 patients ) ( P=.14 ) , with a 95 % confidence interval for the difference of -0.11 to 0.95 . We conclude that any difference in extent of emboli between the 2 surgical techniques is unlikely to be of clinical significance",
" A total of 208 patients were enrolled in a multicenter , prospect i ve r and omized , institutional review board-approved study that compared preoperative surgical plan to postoperative 2-dimensional radiographic alignment measured by a blinded review er for primary total knee arthroplasty ( TKA ) implanted using computer-assisted surgery ( CAS ) compared with conventional TKA instrumentation . The results demonstrated a statistically significant improvement in the coronal tibial component alignment ( P the mechanical axis , femoral coronal/sagittal , and tibial sagittal alignment . Knee Society Score knee and function scores and 6-minute walk test were equivalent between the 2 treatment groups at all postoperative intervals . There was a statistically significant increase in the skin-skin time ( P the time until first bone cut ( P CAS knees compared with those implanted with conventional instrumentation . The use of CAS in this r and omized clinical trial conducted at high-volume centers did not offer a clinical ly meaningful improvement in postoperative alignment , clinical , functional , or safety outcomes compared with conventional TKA",
"This is a r and omized prospect i ve controlled trial comparing the alignment , function , and patient quality -of-life outcomes between patients undergoing conventional ( CONV ) and computer-assisted ( CAS ) knee arthroplasty . One hundred and fifteen patients ( 60 CAS , 55 CONV ) underwent cemented total knee arthroplasty . Three patients were lost to follow-up . Eighty-eight percent ( CAS ) vs 61 % ( CONV ) of knees achieved a mechanical axis within 3 degrees of neutral ( P = .003 ) . Aligning femoral rotation with the epicondylar axis was accurately achieved in CAS and CONV with no significant difference . Patients with coronal alignment within 3 degrees of neutral had superior International Knee Society and Short-Form 12 physical scores at 6 weeks , 3 months , 6 months , and 12 months after surgery . Computer-assisted total knee arthroplasty achieves greater accuracy in implant alignment and this correlates with better knee function and improved quality of life",
"Computer-assisted surgery in knee arthroplasty is gaining popularity ; however , the result ing outcome improvement is controversial . A double-blinded trial was performed with subjects r and omized to undergo surgery with either computer-assisted or nonassisted instruments . Postoperatively , limb and implant alignment and rotation were assessed using both full-length radiographs and computed tomography in addition to clinical scores . One hundred twenty patients ( 141 knees ) were r and omized . No differences in Western Ontario MacMaster Osteoarthritis Score , Short Form-36 , or flexion were seen . More varus limb alignment was seen in the computer-assisted group ( 1.9 ° ) vs the nonassisted group ( 0.9 ° , P = .04 ) with no improvement in alignment precision . Rotational alignment of the components did not differ between groups . Computer-assisted surgery appeared to have minimal effect on knee implant arthroplasty with no improvement in limb alignment or early functional outcome"
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The burden of atrial fibrillation ( AF ) on Western countries healthcare systems is steadily increasing , with > 2 million Americans and 4 million Europeans affected by this condition . It is by far the most common sustained arrhythmia encountered in clinical practice , with a striking impact on morbidity and mortality . With these premises , achieving a definite cure is highly desirable , as this would have profound social and economic implication . In patients with drug-refractory paroxysmal AF ( PAF ) , multiple clinical trials have established the superiority of catheter ablation ( CA ) over further antiarrhythmic drug ( AAD ) therapy for the long-term maintenance of sinus rhythm , to improve quality of life , and reduce hospitalizations . Whether CA should be adopted as a first-line therapy is still a matter of controversy . Approximately 8 years ago , Verma and Natale released an article in Circulation defending the thesis that CA should be adopted as a first-line therapy for AF ; in their support , they referenced the results of a pivotal r and omized trial by the same authors ( ie , Radiofrequency Ablation versus Antiarrhythmic drugs as First-line Treatment of symptomatic atrial fibrillation [ RAAFT ] ) , together with additional considerations such as the mortality benefit of sinus rhythm maintenance , the ineffectiveness of AAD for the rhythm control of AF , and the significant risks associated with AAD therapy . In an antagonist article , Padanilam and Prystowsky defended the role of AAD , given the insufficient evidence supporting CA as a first-line therapy , together with the lack of knowledge on the long-term efficacy and risks of CA , the cost-effectiveness of this strategy , and the reproducibility of the results across different institutions and operators . Today , we think that sufficient evidence has been acquired . In the present article , we adopted a systematic review method to summarize the available evidence and give an opinion on the role of CA as a first-line therapy for PAF . Such an approach has been preferred to the more classical narrative review , to minimize the risk of subjective statements and base the conclusions on quantitative numbers rather than personal opinions | [
"AIMS Current guidelines recommend discontinuation of oral anticoagulation treatment ( OAT ) and switch to heparin 2 - 5 days before catheter ablation of atrial fibrillation ( AF ) . However , increasing evidence leans against the ' bridge therapy ' and support continuation of OAT during the procedure . METHODS AND RESULTS We evaluated the safety of AF ablation among patients with therapeutic OAT . The study population comprised 193 consecutive patients who underwent 228 AF ablation procedures guided by electroanatomical mapping . Periprocedural international normalized ratio was ) . Heparin ( 5000 IU bolus followed by continuous infusion through an open-irrigated ablation catheter ) was used in both groups . No intracardiac echocardiographic guidance was used and activated clotting time ( ACT ) was not monitored . The incidence of major ( intracranial bleeding , tamponade , bleeding that required surgical intervention , or blood transfusion ) and minor bleeding complications and all thrombo-embolic events were registered during the 3-month follow-up . There was no statistical difference in major ( P = 1.0 ) and minor complications ( P = 0.74 ) between the groups . The bleeding complications included one surgically corrected groin haematoma in both groups ( 0.9 % ) , 25 small haematomas at the puncture site ( 11 in Group 1 ( 10.7 % ) and 14 in Group 2 ( 11.2 % ) , P = 0.90 ) , and two minor pericardial effusions in Group 1 . In Group 2 , one patient had ischaemic stroke 16 days after the procedure . CONCLUSION Transseptal puncture and AF ablation can be performed safely in patients with ongoing OAT without intracardiac echocardiographic guidance and ACT monitoring",
"Background — The best approach to management of anticoagulation before and after atrial fibrillation ablation is not known . Methods and Results — We compared outcomes in consecutive patients undergoing pulmonary vein antrum isolation for persistent atrial fibrillation . Early in our practice , warfarin was stopped 3 days before ablation , and a transesophageal echocardiogram was performed to rule out clot . Enoxaparin , initially 1 mg/kg twice daily ( group 1 ) and then 0.5 mg/kg twice daily ( group 2 ) , was used to “ bridge ” patients after ablation . Subsequently , warfarin was continued to maintain the international normalized ratio between 2 and 3.5 ( group 3 ) . Minor bleeding was defined as hematoma that did not require intervention . Major bleeding was defined as either cardiac tamponade , hematoma that required intervention , or bleeding that required blood transfusion . Pulmonary vein ablation was performed in 355 patients ( group 1=105 , group 2=100 , and group 3=150 ) . More patients had spontaneous echocardiographic contrast in groups 1 and 2 . One patient in group 1 had an ischemic stroke compared with 2 patients in group 2 and no patients in group 3 . In group 1 , 23 patients had minor bleeding , 9 had major bleeding , and 1 had pericardial effusion but no tamponade . In group 2 , 19 patients had minor bleeding , and 2 patients developed symptomatic pericardial effusion with need for pericardiocentesis 1 week after discharge . In group 3 , 8 patients developed minor bleeding , and 1 patient developed pericardial effusion with no tamponade . Conclusions — Continuation of warfarin throughout pulmonary vein ablation without administration of enoxaparin is safe and efficacious . This strategy can be an alternative to bridging with enoxaparin or heparin in the periprocedural period",
"AIMS Pulmonary vein antrum isolation ( PVAI ) plays a pivotal role in the comprehensive treatment of atrial fibrillation ( AF ) . The need for effective anticoagulation bridging following PVAI is associated with significant vascular complication rates and increased costs . We investigated the safety of PVAI in patients with therapeutic international normalized ratios ( INR ) the day of the procedure . METHODS A case-control analysis was performed on patients who underwent PVAI with therapeutic INR ( > 2 ) . Patients with normal preprocedure INR served as controls . The incidence of major and minor hematomas , fistulas , vascular injury , and cardiac perforation or tamponade were catalogued . PVAI was performed under fluoroscopic , electro-anatomical , and intracardiac echocardiographic guidance , with an open irrigation ablation technique . RESULTS A total of 194 patients ( mean age 64 + /- 12 ) were included ; 87 patients underwent PVAI with therapeutic INR ( cases ) and 107 with normal INR ( controls ) . Persistent AF was more prevalent than paroxysmal AF in the therapeutic INR group . The mean INR for cases was 2.8 + /- 0.7 compared to 1.4 + /- 0.3 in the control group ( P major adverse events were observed , one in each arm . No significant difference in terms of minor ( 6.5 % vs. 5.7 % , P = 0.23 ) or major ( 0.93 % vs. 1.15 % , P = 0.49 ) vascular events or bleeding was detected between the therapeutic INR and the control group . The combined endpoint of major and minor complications did not differ among groups ( 9.35 % vs. 8.05 % , P = 0.19 ) . CONCLUSION Atrial fibrillation ablation in patients with therapeutic INR on the day of a procedure appears to be safe and feasible . Expensive outpatient anti-coagulation bridging may be safely avoided in this type of population",
"CONTEXT Treatment with antiarrhythmic drugs and anticoagulation is considered first-line therapy in patients with symptomatic atrial fibrillation ( AF ) . Pulmonary vein isolation ( PVI ) with radiofrequency ablation may cure AF , obviating the need for antiarrhythmic drugs and anticoagulation . OBJECTIVE To determine whether PVI is feasible as first-line therapy for treating patients with symptomatic AF . DESIGN , SETTING , AND PARTICIPANTS A multicenter prospect i ve r and omized study conducted from December 31 , 2001 , to July 1 , 2002 , of 70 patients aged 18 to 75 years who experienced monthly symptomatic AF episodes for at least 3 months and had not been treated with antiarrhythmic drugs . INTERVENTION Patients were r and omized to receive either PVI using radiofrequency ablation ( n=33 ) or antiarrhythmic drug treatment ( n=37 ) , with a 1-year follow-up . MAIN OUTCOME MEASURES Recurrence of AF , hospitalization , and quality of life assessment . RESULTS Two patients in the antiarrhythmic drug treatment group and 1 patient in the PVI group were lost to follow-up . At the end of 1-year follow-up , 22 ( 63 % ) of 35 patients who received antiarrhythmic drugs had at least 1 recurrence of symptomatic AF compared with 4 ( 13 % ) of 32 patients who received PVI ( P Hospitalization during 1-year follow-up occurred in 19 ( 54 % ) of 35 patients in the antiarrhythmic drug group compared with 3 ( 9 % ) of 32 in the PVI group ( P antiarrhythmic drug group , the mean ( SD ) number of AF episodes decreased from 12 ( 7 ) to 6 ( 4 ) , after initiating therapy ( P = .01 ) . At 6-month follow-up , the improvement in quality of life of patients in the PVI group was significantly better than the improvement in the antiarrhythmic drug group in 5 subclasses of the Short-Form 36 health survey . There were no thromboembolic events in either group . Asymptomatic mild or moderate pulmonary vein stenosis was documented in 2 ( 6 % ) of 32 patients in the PVI group . CONCLUSION Pulmonary vein isolation appears to be a feasible first-line approach for treating patients with symptomatic AF . Larger studies are needed to confirm its safety and efficacy",
"BACKGROUND In a multicenter , double-blind , placebo-controlled study , the long-term effects of amiodarone on morbidity and mortality in patients with congestive heart failure ( CHF ) and atrial fibrillation ( AF ) were evaluated during a 4-year period . METHODS AND RESULTS Of 667 patients with CHF , 103 ( 15 % ) had AF at baseline . Of these , 51 were r and omized to amiodarone and 52 to placebo . The group with sinus rhythm and the group in AF were comparable except for a higher proportion of AF in patients with nonischemic versus ischemic cardiomyopathy ( 41 % versus 27 % , P mean ventricular response ( VR ) during AF over 24 hours was reduced by amiodarone at 2 weeks ( 20 % , P=0.001 ) , at 6 months ( 18 % , P=0.001 ) , and at 12 months ( 16 % , P=0.006 ) . Maximal VR was reduced 22 % ( P=0.001 ) at 2 weeks , 19 % ( P=0.001 ) at 6 months , and 14 % ( P=0.001 ) at 12 months . Sixteen of 51 patients on amiodarone and 4 of 52 on placebo converted to sinus rhythm during the study ( chi2=9.23 , P=0.002 ) . During follow-up , 11 of 268 patients in sinus rhythm on amiodarone at baseline and 22 of the 263 in sinus rhythm on placebo developed AF ; the difference was significant ( chi2=12.88 , P=0.005 ) . Analysis of total mortality during follow-up showed a significantly lower mortality rate ( P=0 . 04 ) in patients in AF at baseline who subsequently converted to sinus rhythm on amiodarone than in those who did not convert to sinus rhythm on the drug . CONCLUSIONS In patients with CHF , amiodarone has a significant potential to spontaneously convert patients in AF to sinus rhythm , with patients who convert having a lower mortality rate than those who do not . The drug prevented the development of new-onset AF and significantly reduced the VR in those with persistent AF",
"Background — The mainstay of treatment for atrial fibrillation ( AF ) remains pharmacological ; however , catheter ablation has increasingly been used over the last decade . The relative merits of each strategy have not been extensively studied . Methods and Results — We conducted a r and omized multicenter comparison of these 2 treatment strategies in patients with paroxysmal AF resistant to at least 1 antiarrhythmic drug . The primary end point was absence of recurrent AF between months 3 and 12 , absence of recurrent AF after up to 3 ablation procedures , or changes in antiarrhythmic drugs during the first 3 months . Ablation consisted of pulmonary vein isolation in all cases , whereas additional extrapulmonary vein lesions were at the discretion of the physician . Crossover was permitted at 3 months in case of failure . Echocardiographic data , symptom score , exercise capacity , quality of life , and AF burden were evaluated at 3 , 6 , and 12 months by the supervising committee . Of 149 eligible patients , 112 ( 18 women [ 16 % ] ; age , 51.1±11.1 years ) were enrolled and r and omized to ablation ( n=53 ) or “ new ” antiarrhythmic drugs alone or in combination ( n=59 ) . Crossover from the antiarrhythmic drugs and ablation groups occurred in 37 ( 63 % ) and 5 patients ( 9 % ) , respectively ( P=0.0001 ) . At the 1-year follow-up , 13 of 55 patients ( 23 % ) and 46 of 52 patients ( 89 % ) had no recurrence of AF in the antiarrhythmic drug and ablation groups , respectively ( P were significantly higher in the ablation group . Conclusion — This r and omized multicenter study demonstrates the superiority of catheter ablation over antiarrhythmic drugs in patients with AF with regard to maintenance of sinus rhythm and improvement in symptoms , exercise capacity , and quality of life",
"Background —The study was conducted to compare relative safety and efficacy of pulmonary vein antrum isolation ( PVAI ) using intracardiac echocardiographic guidance and circumferential pulmonary vein ablation ( CPVA ) for atrial fibrillation ( AF ) using radiofrequency energy . Methods and Results —Sixty patients ( 81 % men ; 81 % paroxysmal ; age , 56±8 years ) failing 2±1 antiarrhythmic drugs were r and omly assigned to undergo CPVA ( n=30 ) or PVAI ( n=30 ) at 5 centers between December 2004 and October 2007 . CPVA patients had circular lesions placed at least 1 cm outside of the veins . Ipsilateral veins were ablated en block with the end point of disappearance of potentials within the circular lesion . Left atrial roof line and mitral isthmus line were ablated without verification of block . For patients in AF postablation or with AF induced with programmed stimulation , complex fractionated electrograms were mapped and ablated to the end point of AF termination or disappearance of complex fractionated electrograms . PVAI did not include complex fractionated electrogram ablation . Esophageal temperature was monitored and kept within 2 ° C of baseline or under 39 ° C . Success was defined as absence of atrial tachyarrhythmias ( AF/AT ) off antiarrhythmic drugs . There was no difference between CPVA and PVAI regarding to baseline variables , catheter used , duration of the procedure , or RF delivery . Fluoroscopy time was longer with PVAI ( 54±17 minutes versus 77±18 minutes , P=0.0001 ) . No significant complications occurred in either arm . PVAI was more likely to achieve control of AF/AT off antiarrhythmic drugs ( 57 % versus 27 % , P=0.02 ) at 2±1 years of follow-up . Conclusions —A single PVAI procedure is more likely to result in freedom from AF/AT off antiarrhythmic drugs than CPVA supplemented by complex fractionated electrogram ablation in select patients",
"Background —The AFFIRM Study showed that treatment of patients with atrial fibrillation and a high risk for stroke or death with a rhythm-control strategy offered no survival advantage over a rate-control strategy in an intention-to-treat analysis . This article reports an “ on-treatment ” analysis of the relationship of survival to cardiac rhythm and treatment as they changed over time . Methods and Results —Modeling techniques were used to determine the relationships among survival , baseline clinical variables , and time-dependent variables . The following baseline variables were significantly associated with an increased risk of death : increasing age , coronary artery disease , congestive heart failure , diabetes , stroke or transient ischemic attack , smoking , left ventricular dysfunction , and mitral regurgitation . Among the time-dependent variables , the presence of sinus rhythm ( SR ) was associated with a lower risk of death , as was warfarin use . Antiarrhythmic drugs ( AADs ) were associated with increased mortality only after adjustment for the presence of SR . Consistent with the original intention-to-treat analysis , AADs were no longer associated with mortality when SR was removed from the model . Conclusions —Warfarin use improves survival . SR is either an important determinant of survival or a marker for other factors associated with survival that were not recorded , determined , or included in the survival model . Currently available AADs are not associated with improved survival , which suggests that any beneficial antiarrhythmic effects of AADs are offset by their adverse effects . If an effective method for maintaining SR with fewer adverse effects were available , it might be beneficial",
"Background — Data on the comparative value of the circumferential pulmonary vein and the segmental pulmonary vein ablation for interventional treatment of atrial fibrillation are limited . We hypothesized that the circumferential pulmonary vein ablation approach was superior to the segmental pulmonary vein ablation approach . Methods and Results —One hundred patients with highly symptomatic atrial fibrillation were r and omly assigned to undergo either circumferential ( n=50 ) or segmental pulmonary vein ablation ( n=50 ) . Freedom from atrial tachyarrhythmias in a 7-day Holter monitoring at 6 months was the primary end point . Secondary end points were freedom of arrhythmia-related symptoms and a composite of pericardial tamponade , thromboembolic complications , and pulmonary vein stenosis ( safety end point ) . On the basis of the results of the 7-day Holter monitoring at 6 months , 21 patients ( 42 % ) after circumferential pulmonary vein ablation and 33 patients ( 66 % ) after segmental pulmonary vein ablation ( P=0.02 ) were free of atrial tachyarrhythmia episodes . During the 6-month follow-up period , 27 patients ( 54 % ) after circumferential pulmonary vein ablation and 41 patients ( 82 % ) after segmental pulmonary vein ablation remained free of arrhythmia-related symptoms ( P safety end point ( 6 versus 7 events ; P=0.77 ) in the circumferential versus segmental pulmonary vein ablation group , respectively . Conclusions —This study demonstrates no superiority of the circumferential pulmonary vein ablation over segmental pulmonary vein ablation for treatment of atrial fibrillation in terms of efficacy and safety",
"Background : Atrial fibrillation is a common arrhythmia associated with excess morbidity and mortality . We studied temporal changes in hospital admission rates for atrial fibrillation using data from a prospect i ve population -based cohort study spanning 2 decades ( the Copenhagen City Heart Study ) . Methods : The study included baseline data collected in 1981 through 1983 on 10,955 persons age 40 to 79 years and baseline data collected in 1991 through 1994 on 7212 persons age 40 to 79 years . We used hospital diagnosis data from the Danish National Hospital Discharge Register to determine the rate of first hospital admission for atrial fibrillation during 7 years following each of the 2 baseline data collecting periods . Changes in admission rates were analyzed using Cox proportional hazard models . Results : During the 2 7-year periods , 379 subjects were admitted with a hospital diagnosis of atrial fibrillation . The rate of hospital admissions for atrial fibrillation increased among both men and women from the first to the second period ( relative risk = 1.6 ; 95 % confidence interval = 1.3–1.9 [ adjusted for age , sex , prior myocardial infa rct ion , arterial hypertension , diabetes mellitus , electrocardiographic left ventricular hypertrophy , decreased lung function , smoking , height , and weight ] ) . Conclusion : During the latest 10 to 20 years , there has been a 60 % increase in hospital admissions for atrial fibrillation independent of changes in known risk factors . This increase could result from changes in admission threshold or coding practice s , or it could reflect a genuine increase in the population incidence of atrial fibrillation",
"INTRODUCTION Radiofrequency ablation ( RFA ) has become an accepted therapy for atrial fibrillation ( AF ) . The objective of this study was to perform an economic evaluation of RFA versus antiarrhythmic drug therapy ( AAD ) as first-line treatment of symptomatic paroxysmal AF . METHODS To estimate and compare the costs of RFA versus AAD , a decision analytic model was developed using data on AF recurrence , hospitalization rates , AAD use , and treatment crossover rates derived directly from the R and omized Trial of RFA versus AAD as First-Line Treatment of Symptomatic Atrial Fibrillation ( RAAFT ) . Re source utilization was modeled to reflect Canadian clinical practice in AF management . Unit costs of healthcare interactions were based on available Canadian government re sources and published literature . Costs were assessed based on intention-to-treat . Total expected costs were computed to include initial treatment , hospital stay , physician fees , diagnostic tests , and outpatient visits . Sensitivity analyses were performed to account for the uncertainties . The study was conducted from the third party payer 's perspective and costs are reported in 2005 Canadian dollars with 3 % discount rate used in the analysis . RESULTS During the 2-month blanking period following therapy selection , total average costs for RFA and AAD were $ 10,465 and $ 2,556 , respectively ; at 1-year follow-up , these were $ 12,823 and $ 6,053 ; and total 2-year cumulative total average costs were $ 15,303 and $ 14,392 . Sensitivity analyses did not alter the results , suggesting the model is robust . CONCLUSIONS RFA as first-line treatment strategy in patients with symptomatic paroxysmal AF was cost neutral 2 years after the initial procedure compared to AAD",
"AIMS We conducted a multi-centre , prospect i ve , controlled , r and omized trial to investigate the adjunctive role of ablation therapy to antiarrhythmic drug therapy in preventing atrial fibrillation ( AF ) relapses in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy had already failed . METHODS AND RESULTS One hundred and thirty seven patients were r and omized to ablation and antiarrhythmic drug therapy ( ablation group ) or antiarrhythmic drug therapy alone ( control group ) . In the ablation group , patients underwent cavo-tricuspid and left inferior pulmonary vein (PV)-mitral isthmus ablation plus circumferential PV ablation . The primary end-point of the study was the absence of any recurrence of atrial arrhythmia lasting > 30 s in the 1-year follow-up period , after 1-month blanking period . Three ( 4.4 % ) major complications were related to ablation : one patient had a stroke during left atrium ablation , another suffered transient phrenic paralysis , and the third had a pericardial effusion which required pericardiocentesis . After 12 months of follow-up , 63/69 ( 91.3 % ) control group patients had at least one AF recurrence , whereas 30/68 ( 44.1 % ) ( P atrial arrhythmia recurrence ( four patients had atrial flutter , 26 patients AF ) . CONCLUSION Ablation therapy combined with antiarrhythmic drug therapy is superior to antiarrhythmic drug therapy alone in preventing atrial arrhythmia recurrences in patients with paroxysmal or persistent AF in whom antiarrhythmic drug therapy has already failed",
"BACKGROUND Left ventricular dysfunction after myocardial infa rct ion is associated with an increased risk of death . Other studies have suggested that a potassium-channel blocker might reduce this risk with minimal adverse effects . We investigated whether d-sotalol , a pure potassium-channel blocker with no clinical ly significant beta-blocking activity , could reduce all-cause mortality in these high-risk patients . METHODS Patients with a left ventricular ejection fraction of 40 % or less and either a recent ( 6 - 42 days ) myocardial infa rct ion or symptomatic heart failure with a remote ( > 42 days ) myocardial infa rct ion were r and omly assigned d-sotalol ( 100 mg increased to 200 mg twice daily , if tolerated ) or matching placebo twice daily . FINDINGS After 3121 of the planned 6400 patients had been recruited , the trial was stopped . Among 1549 patients assigned d-sotalol , there were 78 deaths ( 5.0 % ) compared with 48 deaths ( 3.1 % ) among the 1572 patients assigned placebo ( relative risk 1.65 [ 95 % CI 1.15 - 2.36 ] , p = 0.006 ) . Presumed arrhythmic deaths ( relative risk 1.77 [ 1.15 - 2.74 ] , p = 0.008 ) accounted for the increased mortality . The effect was greater in patients with a left ventricular ejection fraction of 31 - 40 % than in those with lower ( 1549 patients evaluated , administration of d-sotalol was associated with increased mortality , which was presumed primarily to be due to arrhythmias . The prophylactic use of a specific potassium-channel blocker does not reduce mortality , and may be associated with increased mortality in high-risk patients after myocardial infa rct ion",
"OBJECTIVES We compared ablation strategy with antiarrhythmic drug therapy ( ADT ) in patients with paroxysmal atrial fibrillation ( PAF ) . BACKGROUND Atrial fibrillation ( AF ) ablation strategy is superior to ADT in patients with an initial history of PAF , but its role in patients with a long history of AF as compared with ADT remains a challenge . METHODS One hundred ninety-eight patients ( age , 56 + /- 10 years ) with PAF of 6 + /- 5 years ' duration ( mean AF episodes 3.4/month ) who had failed ADT were r and omized to AF ablation by circumferential pulmonary vein ablation ( CPVA ) or to the maximum tolerable doses of another ADT , which included flecainide , sotalol , and amiodarone . Crossover to CPVA was allowed after 3 months of ADT . RESULTS By Kaplan-Meier analysis , 86 % of patients in the CPVA group and 22 % of those in the ADT group who did not require a second ADT were free from recurrent atrial tachyarrhythmias ( AT ) ( p CPVA and ADT groups , respectively , were AT-free . Ejection fraction , hypertension , and age independently predicted AF recurrences in the ADT group . Circumferential pulmonary vein ablation was associated with fewer cardiovascular hospitalizations ( p transient ischemic attack and 1 pericardial effusion occurred in the CPVA group ; side effects of ADT were observed in 23 patients . CONCLUSIONS Circumferential pulmonary vein ablation is more successful than ADT for prevention of PAF with few complications . Atrial fibrillation ablation warrants consideration in selected patients in whom ADT had already failed and maintenance of sinus rhythm is desired . ( A Controlled R and omized Trial of CPVA Versus Antiarrhythmic Drug Therapy in for Paroxysmal AF : APAF/01 ; http:// clinical trials.gov/ct/show ; NCT00340314 )",
"Introduction A recent single-center report indicated that the performance of atrial fibrillation ablation in patients on uninterrupted warfarin using a conventional deflectable tip electrode ablation catheter may be as safe as peri-procedural discontinuation of warfarin and bridging with heparin . Novel multi-electrode array catheters for atrial fibrillation ablation are currently undergoing clinical evaluation . While offering the possibility of more rapid atrial fibrillation ablation , they are stiffer and necessitate the deployment of larger deflectable transseptal sheaths , and it remains to be determined if they increase the risk of cardiac perforation and vascular injury . Such potential risks would have implication s for a strategy of uninterrupted peri-procedural anticoagulation . Method and Results We audited the safety outcomes of our atrial fibrillation ablation procedures using multi-electrode array ablation catheters in patients on uninterrupted warfarin ( CHADS2 score ≥ 2 ) and in patients not on warfarin ( uninterrupted aspirin ) . Two bleeding complications occurred in 49 patients on uninterrupted warfarin , both of which were managed successfully without long-term sequelae , and no bleeding complication occurred in 32 patients not on warfarin ( uninterrupted aspirin ) . There were no thromboembolic events or other complication with either anticoagulant regimen . Conclusion Despite the larger diameter and increased stiffness of multi-electrode array catheters and their deflectable transseptal sheaths , their use for catheter ablation in patients with atrial fibrillation on uninterrupted warfarin in this single-center experience does not appear to be unsafe , and thus , an adequately powered multicenter prospect i ve r and omized controlled trial should be considered",
"BACKGROUND The restoration and maintenance of sinus rhythm is a desirable goal in patients with atrial fibrillation , because the prevention of recurrences can improve cardiac function and relieve symptoms . Uncontrolled studies have suggested that amiodarone in low doses may be more effective and safer than other agents in preventing recurrence , but this agent has not been tested in a large , r and omized trial . METHODS We undertook a prospect i ve , multicenter trial to test the hypothesis that low doses of amiodarone would be more efficacious in preventing recurrent atrial fibrillation than therapy with sotalol or propafenone . We r and omly assigned patients who had had at least one episode of atrial fibrillation within the previous six months to amiodarone or to sotalol or propafenone , given in an open-label fashion . The patients in the group assigned to sotalol or propafenone underwent a second r and omization to determine whether they would receive sotalol or propafenone first ; if the first drug was unsuccessful the second agent was prescribed . Loading doses of the drugs were administered and electrical cardioversion was performed ( if necessary ) within 21 days after r and omization for all patients in both groups . The follow-up period began 21 days after r and omization . The primary end point was the length of time to a first recurrence of atrial fibrillation . RESULTS Of the 403 patients in the study , 201 were assigned to amiodarone and 202 to either sotalol ( 101 patients ) or propafenone ( 101 patients ) . After a mean of 16 months of follow-up , 71 of the patients who were assigned to amiodarone ( 35 percent ) and 127 of those who were assigned to sotalol or propafenone ( 63 percent ) had a recurrence of atrial fibrillation ( P Adverse events requiring the discontinuation of drug therapy occurred in 18 percent of the patients receiving amiodarone , as compared with 11 percent of those treated with sotalol or propafenone ( P=0.06 ) . CONCLUSIONS Amiodarone is more effective than sotalol or propafenone for the prevention of recurrences of atrial fibrillation",
"OBJECTIVES This study was design ed to compare two treatment strategies in patients with atrial fibrillation(AF ) : rhythm-control ( restoration and maintenance of sinus rhythm ) and rate-control ( pharmacologic or invasive rate-control and anticoagulation ) . BACKGROUND Atrial fibrillation is the most common arrhythmia . It is unclear whether a strategy of rhythm- or rate-control is better in terms of mortality , morbidity , and quality of life . METHODS The Strategies of Treatment of Atrial Fibrillation ( STAF ) multicenter pilot trial r and omized 200 patients ( 100 per group ) with persistent AF to rhythm- or rate-control . The combined primary end point was a combination of death , cardiopulmonary resuscitation , cerebrovascular event , and systemic embolism . RESULTS After 19.6 + /- 8.9 months ( range 0 to 36 months ) there was no difference in the primary end point between rhythm-control ( 9/100 ; 5.54%/year ) and rate-control ( 10/100 ; 6.09%/year ; p = 0.99 ) . The percentage of patients in sinus rhythm in the rhythm-control group after up to four cardioversions during the follow-up period ( rate-control group ) was 23 % ( 0 % ) at 36 months . Eighteen primary end points occurred in atrial fibrillation ; only one occurred in sinus rhythm ( p = 0.049 ) . CONCLUSIONS The STAF pilot study showed no differences between the two treatment strategies in all end points except hospitalizations . These data suggest that there was no benefit in attempting rhythm-control in these patients with a high risk of arrhythmia recurrence . It remains unclear whether the results in the rhythm-control group would have been better if sinus rhythm had been maintained in a higher proportion of patients , as all but one end point occurred during AF",
"BACKGROUND Atrial fibrillation is a common arrhythmia in patients with left ventricular dysfunction associated with increased morbidity and mortality . The present study investigated the potential of dofetilide to restore and maintain sinus rhythm in patients with left ventricular dysfunction , which might reduce mortality and hospitalizations . METHODS AND RESULTS In the Danish Investigations of Arrhythmia and Mortality ON Dofetilide ( DIAMOND ) studies , 506 patients were in atrial fibrillation ( AF ) or atrial flutter ( AFl ) at baseline . Over the course of study , cardioversion occurred in 148 ( 59 % ) dofetilide- and 86 ( 34 % ) placebo-treated patients . In these patients , the probability of maintaining sinus rhythm for 1 year was 79 % with dofetilide versus 42 % with placebo ( P Dofetilide had no effect on all-cause mortality , but restoration and maintenance of sinusrhythm ( independent of study treatment ) was associated with a significant reduction in mortality ( risk ratio [ RR ] , 0.44 ; 95 % CI , 0.30 to 0.64 ; P dofetilide therapy was associated with a significantly lower risk ratio versus placebo for either all-cause ( RR , 0.70 ; 95 % CI , 0.56 to 0.89 ; P congestive heart failure ( RR , 0.69 ; 95 % CI , 0.51 to 0.93 ; P rehospitalization . CONCLUSIONS Dofetilide is safe and increases the probability of obtaining and maintaining sinus rhythm in patients with structural heart disease . The present study suggests that restoration of sinus rhythm -- on placebo or dofetilide -- is associated with improved survival",
"INTRODUCTION Catheter ablation for atrial fibrillation is an effective treatment for symptomatic patients who have failed drug therapy . Recent studies using intracardiac echocardiography have demonstrated that ablation can be performed safely on uninterrupted warfarin and may be superior to bridging low molecular weight heparin ( LMWH ) . We sought to assess the safety of an uninterrupted warfarin protocol using a simplified ablation protocol in a prospect i ve controlled study . METHODS Two anticoagulation regimes for patients undergoing catheter ablation for atrial fibrillation were evaluated -- a bridging LMWH group and an uninterrupted warfarin group . Bleeding complications were compared between the 2 groups . RESULTS In total 198 patients were evaluated ( 109 bridging LMWH , 89 uninterrupted warfarin ) . The preprocedure INR in the LMWH group ( mean age 60.6 years , 72 % male ) was 1.2 ± 0.3 compared to 2.3 ± 0.5 in the uninterrupted warfarin group ( mean age 60.9 years , 69 % male ) . The primary outcome ( a composite of major and minor bleeding complications ) was observed in 78 % in the LMWH group compared to 56 % in the warfarin group ( P = 0.001 ) , mainly due to increased pain at the venous access site ( 41 % vs 16 % , P = 0.001 ) . Two patients undergoing ablation on warfarin required pericardiocentesis for cardiac tamponade . Drug costs were lower in the warfarin group ( $ 64.77 ± 31.86 vs $ 20.76 ± 15.60 , P = 0.005 ) , but the overall cost of treatment per patient ( including bed occupancy costs ) was similar in the LMWH group compared to the warfarin group ( $ 883.96 ± 278.78 vs $ 816.59 ± 182.72 , P = 0.06 ) . CONCLUSION Catheter ablation for atrial fibrillation can be performed safely on uninterrupted warfarin without intracardiac echocardiography , with a reduced risk of bleeding complications ",
"BACKGROUND There are two approaches to the treatment of atrial fibrillation : one is cardioversion and treatment with antiarrhythmic drugs to maintain sinus rhythm , and the other is the use of rate-controlling drugs , allowing atrial fibrillation to persist . In both approaches , the use of anticoagulant drugs is recommended . METHODS We conducted a r and omized , multicenter comparison of these two treatment strategies in patients with atrial fibrillation and a high risk of stroke or death . The primary end point was overall mortality . RESULTS A total of 4060 patients ( mean [ + /-SD ] age , 69.7+/-9.0 years ) were enrolled in the study ; 70.8 percent had a history of hypertension , and 38.2 percent had coronary artery disease . Of the 3311 patients with echocardiograms , the left atrium was enlarged in 64.7 percent and left ventricular function was depressed in 26.0 percent . There were 356 deaths among the patients assigned to rhythm-control therapy and 310 deaths among those assigned to rate-control therapy ( mortality at five years , 23.8 percent and 21.3 percent , respectively ; hazard ratio , 1.15 [ 95 percent confidence interval , 0.99 to 1.34 ] ; P=0.08 ) . More patients in the rhythm-control group than in the rate-control group were hospitalized , and there were more adverse drug effects in the rhythm-control group as well . In both groups , the majority of strokes occurred after warfarin had been stopped or when the international normalized ratio was subtherapeutic . CONCLUSIONS Management of atrial fibrillation with the rhythm-control strategy offers no survival advantage over the rate-control strategy , and there are potential advantages , such as a lower risk of adverse drug effects , with the rate-control strategy . Anticoagulation should be continued in this group of high-risk patients",
"AIMS The aims of the study were ( i ) to assess the characteristics of patients selected for atrial fibrillation ( AF ) ablation as first-line therapy , ( ii ) to identify current clinical criteria for such a strategy , and ( iii ) to analyse the outcome compared with patients who had failure of antiarrhythmic drug ( AAD ) therapy prior to ablation . METHODS AND RESULTS Consecutive patients undergoing ablation of AF were included in a prospect i ve registry . Serial long-term electrocardiogram monitoring and clinical follow-up were performed after 3 , 6 , and 12 months . Out of 434 patients , 17 % underwent AF catheter ablation as first-line therapy ( AAD- ) , and 83 % had undergone at least one AAD trial ( AAD+ ) . In AAD- patients , the reasons for this strategy were : ( i ) patient preference , n= 51 ( 71 % ) ; ( ii ) contra-indication to AAD , n= 21 ( 29 % ) . Atrial fibrillation duration prior to ablation was shorter ( 52 ± 54 vs. 78 ± 81 months , P= 0.005 ) , and the percentage of patients hospitalized for AF ( 32 % vs. 48 % , P= 0.01 ) was lower in AAD- patients . Long-term multiple procedure success rate ( 78 % vs. 64 % , P= 0.03 ) was higher in the AAD- group , and there were less repeat ablations in this group ( 21 % vs. 38 % , P= 0.01 ) . CONCLUSION Catheter ablation was first-line therapy of AF in a significant number of patients , according either to patient preference or to medical factors , and this had important implication s. Ablative therapy was performed at an earlier stage of the disease , and was associated with a significantly higher success rate and with a decreased need for repeat procedures",
"The limited efficacy and proarrhythmic risks of antiarrhythmia agents have result ed in alternative therapeutic approaches . Radiofrequency ablation has been reported to be an effective treatment of patients with atrial fibrillation . However , there is no r and omized clinical trial comparing drug and radiofrequency ablation . The authors r and omized 30 patients with chronic atrial fibrillation refractory to medication into amiodarone and radiofrequency ablation . The primary objective of this study was to compare the efficacy of amiodarone and radiofrequency ablation in the maintenance of sinus rhythm at 1 year after r and omization . Pulmonary vein isolation and linear ablation of right atrium was the technique used for radiofrequency ablation . There were no significant differences in baseline patient characteristics between the 2 groups . The results of this study showed that the probability of free from atrial fibrillation was better in the radiofrequency ablation group compared to amiodarone ( 78.6 % in the ablation group and 40 % in the amiodarone group , p = 0.018 ) . Radiofrequency ablation results in a significant reduction in symptoms relating to atrial fibrillation and a significant improvement in quality of life , whereas amiodarone had no significant effect on symptoms and quality of life . There was an ischemic stroke as a major complication related to radiofrequency ablation . Amiodarone was associated with adverse effects in 46.7 per cent of patients and needed discontinuation in 1 patient . In conclusion , radiofrequency ablation is an effective alternative treatment in patients with atrial fibrillation refractory to medication",
"CONTEXT Antiarrhythmic drugs are commonly used for prevention of recurrent atrial fibrillation ( AF ) despite inconsistent efficacy and frequent adverse effects . Catheter ablation has been proposed as an alternative treatment for paroxysmal AF . OBJECTIVE To determine the efficacy of catheter ablation compared with antiarrhythmic drug therapy ( ADT ) in treating symptomatic paroxysmal AF . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve , multicenter , r and omized ( 2:1 ) , unblinded , Bayesian- design ed study conducted at 19 hospitals of 167 patients who did not respond to at least 1 antiarrhythmic drug and who experienced at least 3 AF episodes within 6 months before r and omization . Enrollment occurred between October 25 , 2004 , and October 11 , 2007 , with the last follow-up on January 19 , 2009 . INTERVENTION Catheter ablation ( n = 106 ) or ADT ( n = 61 ) , with assessment for effectiveness in a comparable 9-month follow-up period . MAIN OUTCOME MEASURES Time to protocol -defined treatment failure . The proportion of patients who experienced major treatment-related adverse events within 30 days of catheter ablation or ADT was also reported . RESULTS At the end of the 9-month effectiveness evaluation period , 66 % of patients in the catheter ablation group remained free from protocol -defined treatment failure compared with 16 % of patients treated with ADT . The hazard ratio of catheter ablation to ADT was 0.30 ( 95 % confidence interval , 0.19 - 0.47 ; P 30-day treatment-related adverse events occurred in 5 of 57 patients ( 8.8 % ) treated with ADT and 5 of 103 patients ( 4.9 % ) treated with catheter ablation . Mean quality of life scores improved significantly in patients treated by catheter ablation compared with ADT at 3 months ; improvement was maintained during the course of the study . CONCLUSION Among patients with paroxysmal AF who had not responded to at least 1 antiarrhythmic drug , the use of catheter ablation compared with ADT result ed in a longer time to treatment failure during the 9-month follow-up period . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00116428",
"Background — Catheter ablation of atrial fibrillation is associated with the potential risk of periprocedural stroke , which can range between 1 % and 5 % . We developed a prospect i ve data base to evaluate the prevalence of stroke over time and to assess whether the periprocedural anticoagulation strategy and use of open irrigation ablation catheter have result ed in a reduction of this complication . Methods and Results — We collected data from 9 centers performing the same ablation procedure with the same anticoagulation protocol . We divided the patients into 3 groups : ablation with an 8-mm catheter off warfarin ( group 1 ) , ablation with an open irrigated catheter off warfarin ( group 2 ) , and ablation with an open irrigated catheter on warfarin ( group 3 ) . Outcome data on stroke/transient ischemic attack and bleeding complications during and early after the procedures were collected . Of 6454 consecutive patients in the study , 2488 were in group 1 , 1348 were in group 2 , and 2618 were in group 3 . Periprocedural stroke/transient ischemic attack occurred in 27 patients ( 1.1 % ) in group 1 and 12 patients ( 0.9 % ) in group 2 . Despite a higher prevalence of nonparoxysmal atrial fibrillation and more patients with CHADS2 ( congestive heart failure , hypertension , age > 75 years , diabetes mellitus , and prior stroke or transient ischemic attack ) score > 2 , no stroke/transient ischemic attack was reported in group 3 . Complications among groups 1 , 2 , and 3 , including major bleeding ( 10 [ 0.4 % ] , 11 [ 0.8 % ] , and 10 [ 0.4 % ] , respectively ; P>0.05 ) and pericardial effusion ( 11 [ 0.4 % ] , 11 [ 0.8 % ] , and 12 [ 0.5 % ] ; P>0.05 ) , were equally distributed . Conclusion — The combination of an open irrigation ablation catheter and periprocedural therapeutic anticoagulation with warfarin may reduce the risk of periprocedural stroke without increasing the risk of pericardial effusion or other bleeding complications"
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BACKGROUND Studies have shown that interventions which reduce total and low-density lipoprotein cholesterol levels also reduce coronary heart disease ( CHD ) and stroke events in those with a history of CHD . However , it is uncertain whether treatment to alter cholesterol levels can prevent recurrence of either stroke or subsequent cardiovascular events and whether differences in outcomes exist between classes of lipid-lowering therapy . This is an up date of a Cochrane review first published in 2002 . OBJECTIVES To investigate the effect of altering serum lipids pharmacologically for preventing subsequent cardiovascular disease and stroke recurrence in patients with a history of stroke . SEARCH STRATEGY We search ed the Cochrane Stroke Group Trials Register ( last search ed December 2008 ) , the Cochrane Central Register of Controlled Trials ( The Cochrane Library Issue 3 , 2008 ) , MEDLINE ( 1966 to December 2008 ) and EMBASE ( 1980 to December 2008 ) . We contacted pharmaceutical companies known to produce a lipid-lowering agent for information on relevant publications or unpublished work . SELECTION CRITERIA Unconfounded r and omised trials of participants aged 18 years and over with a history of stroke or transient ischaemic attack ( TIA ) . DATA COLLECTION AND ANALYSIS Two review authors independently selected trials , assessed quality and extracted data . MAIN RESULTS We included eight studies involving approximately 10,000 participants . The active interventions were pravastatin , atorvastatin , simvastatin , clofibrate , and conjugated oestrogen . Fixed-effect analysis showed no overall effect on stroke recurrence but statin therapy alone had a marginal benefit in reducing subsequent cerebrovascular events in those with a previous history of stroke or TIA ( odds ratio ( OR ) 0.88 , 95 % confidence interval ( CI ) 0.77 to 1.00 ) . There was no evidence that such intervention reduced all-cause mortality or sudden death ( OR 1.00 , 95 % CI 0.83 to 1.20 ) . Three statin trials showed a reduction in subsequent serious vascular events ( OR 0.74 , 95 % CI 0.67 to 0.82 ) . AUTHORS ' CONCLUSIONS There is evidence that statin therapy in patients with a history of ischaemic stroke or TIA significantly reduces subsequent major coronary events but only marginally reduces the risk of stroke recurrence . There is no clear evidence of beneficial effect from statins in those with previous haemorrhagic stroke and it is unclear whether statins should be started immediately post stroke or later . In view of this and the evidence of the benefit of statin therapy in those with a history of CHD , patients with ischaemic stroke or TIA , with or without a history of established CHD , should receive statins | [
"BACKGROUND Patients with transient ischaemic attack ( TIA ) or minor stroke are at high immediate risk of stroke . The optimum early treatment options for these patients are not known . METHODS Within 24 h of symptom onset , we r and omly assigned , in a factorial design , 392 patients with TIA or minor stroke to clopidogrel ( 300 mg loading dose then 75 mg daily ; 198 patients ) or placebo ( 194 patients ) , and simvastatin ( 40 mg daily ; 199 patients ) or placebo ( 193 patients ) . All patients were also given aspirin and were followed for 90 days . Descriptive analyses were done by intention to treat . The primary outcome was total stroke ( ischaemic and haemorrhagic ) within 90 days . Safety outcomes included haemorrhage related to clopidogrel and myositis related to simvastatin . This study is registered as an International St and ard R and omised Controlled Trial ( number 35624812 ) and with Clinical Trials.gov ( NCT00109382 ) . FINDINGS The median time to stroke outcome was 1 day ( range 0 - 62 days ) . The trial was stopped early due to a failure to recruit patients at the prespecified minimum enrolment rate because of increased use of statins . 14 ( 7.1 % ) patients on clopidogrel had a stroke within 90 days compared with 21 ( 10.8 % ) patients on placebo ( risk ratio 0.7 [ 95 % CI 0.3 - 1.2 ] ; absolute risk reduction -3.8 % [ 95 % CI -9.4 to 1.9 ] ; p=0.19 ) . 21 ( 10.6 % ) patients on simvastatin had a stroke within 90 days compared with 14 ( 7.3 % ) patients on placebo ( risk ratio 1.3 [ 0.7 - 2.4 ] ; absolute risk increase 3.3 % [ -2.3 to 8.9 ] ; p=0.25 ) . The interaction between clopidogrel and simvastatin was not significant ( p=0.64 ) . Two patients on clopidogrel had intracranial haemorrhage compared with none on placebo ( absolute risk increase 1.0 % [ -0.4 to 2.4 ] ; p=0.5 ) . There was no difference between groups for the simvastatin safety outcomes . INTERPRETATION Immediately after TIA or minor stroke , patients are at high risk of stroke , which might be reduced by using clopidogrel in addition to aspirin . The haemorrhagic risks of the combination of aspirin and clopidogrel do not seem to offset this potential benefit . We were unable to provide evidence of benefit of simvastatin in this setting . This aggressive prevention approach merits further study",
"BACKGROUND Although statins reduce coronary and cerebrovascular morbidity and mortality in middle-aged individuals , their efficacy and safety in elderly people is not fully established . Our aim was to test the benefits of pravastatin treatment in an elderly cohort of men and women with , or at high risk of developing , cardiovascular disease and stroke . METHODS We did a r and omised controlled trial in which we assigned 5804 men ( n=2804 ) and women ( n=3000 ) aged 70 - 82 years with a history of , or risk factors for , vascular disease to pravastatin ( 40 mg per day ; n=2891 ) or placebo ( n=2913 ) . Baseline cholesterol concentrations ranged from 4.0 mmol/L to 9.0 mmol/L. Follow-up was 3.2 years on average and our primary endpoint was a composite of coronary death , non-fatal myocardial infa rct ion , and fatal or non-fatal stroke . Analysis was by intention-to-treat . FINDINGS Pravastatin lowered LDL cholesterol concentrations by 34 % and reduced the incidence of the primary endpoint to 408 events compared with 473 on placebo ( hazard ratio 0.85 , 95 % CI 0.74 - 0.97 , p=0.014 ) . Coronary heart disease death and non-fatal myocardial infa rct ion risk was also reduced ( 0.81 , 0.69 - 0.94 , p=0.006 ) . Stroke risk was unaffected ( 1.03 , 0.81 - 1.31 , p=0.8 ) , but the hazard ratio for transient ischaemic attack was 0.75 ( 0.55 - 1.00 , p=0.051 ) . New cancer diagnoses were more frequent on pravastatin than on placebo ( 1.25 , 1.04 - 1.51 , p=0.020 ) . However , incorporation of this finding in a meta- analysis of all pravastatin and all statin trials showed no overall increase in risk . Mortality from coronary disease fell by 24 % ( p=0.043 ) in the pravastatin group . Pravastatin had no significant effect on cognitive function or disability . INTERPRETATION Pravastatin given for 3 years reduced the risk of coronary disease in elderly individuals . PROSPER therefore extends to elderly individuals the treatment strategy currently used in middle aged people",
" A total of 462 patients ( mean age 52 years ) affected by reversible focal ischemic attacks ( RIAs ) were followed prospect ively in 8 neurologic institutions in Italy for 4 years . All cases were evaluated with a cerebral angiography and 21 % of angiograms were normal . At the end of the follow-up period the cumulated probability for death , stroke , cardiac event and new RIA was respectively 7 % , 8 % , 3 % and 36 % . The predictive value of the baseline characteristics of this series was evaluated by a multifactorial analysis which showed that RIA and stroke ( specific cerebrovascular risk ) were more likely to develop in patients with a history of more than one RIA and in those in whom multiple vascular territories were involved . Moreover , previous myocardial infa rct ion , intermittent claudication , angina pectoris , time elapsed since the first attack , and duration and severity of the attack itself were independently associated with general cardiovascular risk ( death , stroke and myocardial infa rct ion ) . We conclude that predictive factors , and thus also pathogenetic mechanisms , may be different for general cardiovascular risk and specific cerebrovascular risk in RIA patients",
"BACKGROUND The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome . No study , however , has assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease ( CHD ) in hypertensive patients who are not conventionally deemed dyslipidaemic . METHODS Of 19342 hypertensive patients ( aged 40 - 79 years with at least three other cardiovascular risk factors ) r and omised to one of two antihypertensive regimens in the Anglo-Sc and inavian Cardiac Outcomes Trial , 10305 with non-fasting total cholesterol concentrations 6.5 mmol/L or less were r and omly assigned additional atorvastatin 10 mg or placebo . These patients formed the lipid-lowering arm of the study . We planned follow-up for an average of 5 years , the primary endpoint being non-fatal myocardial infa rct ion and fatal CHD . Data were analysed by intention to treat . FINDINGS Treatment was stopped after a median follow-up of 3.3 years . By that time , 100 primary events had occurred in the atorvastatin group compared with 154 events in the placebo group ( hazard ratio 0.64 [ 95 % CI 0.50 - 0.83 ] , p=0.0005 ) . This benefit emerged in the first year of follow-up . There was no significant heterogeneity among prespecified subgroups . Fatal and non-fatal stroke ( 89 atorvastatin vs 121 placebo , 0.73 [ 0.56 - 0.96 ] , p=0.024 ) , total cardiovascular events ( 389 vs 486 , 0.79 [ 0.69 - 0.90 ] , p=0.0005 ) , and total coronary events ( 178 vs 247 , 0.71 [ 0.59 - 0.86 ] , p=0.0005 ) were also significantly lowered . There were 185 deaths in the atorvastatin group and 212 in the placebo group ( 0.87 [ 0.71 - 1.06 ] , p=0.16 ) . Atorvastatin lowered total serum cholesterol by about 1.3 mmol/L compared with placebo at 12 months , and by 1.1 mmol/L after 3 years of follow-up . INTERPRETATION The reductions in major cardiovascular events with atorvastatin are large , given the short follow-up time . These findings may have implication s for future lipid-lowering guidelines",
"ABSTRACT — The long‐term prognosis and quality of life of 201 patients admitted to hospital with reversible ischemic attacks ( RIA ) were estimated in a prospect i ve study . The median follow‐up time was 58 months . Further RIAs were reported by 91 patients ( 45 % ) and 48 ( 24 % ) suffered a stroke . The risk of stroke was markedly higher in the first 6 months after RIA , after which the annual stroke rate was rather constant with an average of 4.8 % , about 8 times higher than expected . The average annual mortality rate for the RIA patients was 5.9 % , which is significantly higher than expected . Cardiovascular deaths accounted for more than half of all deaths , stroke for one fourth . Life‐table analysis of subgroups disclosed a much more favorable prognosis for women under 60 years . High systolic blood pressure , diabetes , and previous myocardial infa rct ion were identified as risk factors . The occurrence of RIA had significantly influenced the quality of life and occupational status for the majority of the patients , even for those who did not suffer a subsequent stroke . Decreased working capacity , general asthenia and fatigue and impaired memory were the most common complaints . We conclude that RIA may be a more serious vascular event than generally believed . Apart from carrying a substantial risk of stroke and death , even a single RIA can cause permanent psychological dysfunction influencing the quality of life",
"BACKGROUND The role of lipid modification in stroke prevention is controversial , although increasing evidence suggests that HMG-CoA reductase inhibition may reduce cerebrovascular events in patients with prevalent coronary artery disease . METHODS AND RESULTS To test the hypothesis that cholesterol reduction with pravastatin may reduce stroke incidence after myocardial infa rct ion , we followed 4159 subjects with average total and LDL serum cholesterol levels ( mean , 209 and 139 mg/dL , respectively ) who had sustained an infa rct ion an average of 10 months before study entry and who were r and omized to pravastatin 40 mg/d or placebo in the Cholesterol and Recurrent Events ( CARE ) trial . Using prospect ively defined criteria , we assessed the incidence of stroke , a prespecified secondary end point , and transient ischemic attack ( TIA ) over a median 5-year follow-up period . Patients were well matched for stroke risk factors and the use of antiplatelet agents ( 85 % of subjects in each group ) . Compared with placebo , pravastatin lowered total serum cholesterol by 20 % , LDL cholesterol by 32 % , and triglycerides by 14 % and raised HDL cholesterol by 5 % over the course of the trial . A total of 128 strokes ( 52 on pravastatin , 76 on placebo ) and 216 strokes or TIAs ( 92 on pravastatin , 124 on placebo ) were observed , representing a 32 % reduction ( 95 % CI , 4 % to 52 % , P=0.03 ) in all-cause stroke and 27 % reduction in stroke or TIA ( 95 % CI , 4 % to 44 % , P=0.02 ) . All categories of strokes were reduced , and treatment effect was similar when adjusted for age , sex , history of hypertension , cigarette smoking , diabetes , left ventricular ejection fraction , and baseline total , HDL , and LDL cholesterol and triglyceride levels . There was no increase in hemorrhagic stroke in patients on pravastatin compared with placebo ( 2 versus 6 , respectively ) . CONCLUSIONS Pravastatin significantly reduced stroke and stroke or TIA incidence after myocardial infa rct ion in patients with average serum cholesterol levels despite the high concurrent use of antiplatelet therapy",
"BACKGROUND AND PURPOSE Rebleeding in patients with primary intracerebral hemorrhage is considered uncommon , but there are no precise data to support this opinion . The purpose of this study was to assess the incidence and predictors of recurrent bleeding in survivors of primary intracerebral hemorrhage . METHODS As part of a prospect i ve study , 112 survivors of a first primary intracerebral hemorrhage were followed up for a mean period of 84.1 months after their discharge . To ascertain risk factors that may influence rebleeding , several demographic , medical history , clinical , and laboratory variables were collected and analyzed . RESULTS Twenty-four percent ( 27/112 ) of survivors experienced one or more rebleeding during the follow-up period , in 8 cases ( 30 % ) in the first year of follow-up ; in the others recurrence occurred later , up to 11.5 years . Rebleeding had a high mortality rate : 70 % of patients died as a consequence of their second or third hemorrhage . Univariate and multivariate analyses showed that lobar location of the first hemorrhage was the only significant predictor of rebleeding . Patients with rebleeding were more frequently older , more often had a history of previous transient ischemic attack or ischemic stroke , and less often had hyperlipidemia than patients without rebleeding , although these correlations did not reach statistical significance . During follow-up , poor control of arterial hypertension was found in 7 % of hypertensive patients without rebleeding and in 47 % of hypertensive patients with rebleeding . CONCLUSIONS Our study showed that rebleeding after a first primary intracerebral hemorrhage is not as uncommon as is usually believed . The risk of rebleeding seems to be particularly high after hemorrhage at the junction of the gray and white matter , a site regarded as typical of hemorrhages due to amyloid angiopathy , and when arterial hypertension is poorly controlled",
"CONTEXT Hypertension is associated with a significantly increased risk of morbidity and mortality . Only diuretics and beta-blockers have been shown to reduce this risk in long-term clinical trials . Whether newer antihypertensive agents reduce the incidence of cardiovascular disease ( CVD ) is unknown . OBJECTIVE To compare the effect of doxazosin , an alpha-blocker , with chlorthalidone , a diuretic , on incidence of CVD in patients with hypertension as part of a study of 4 types of antihypertensive drugs : chlorthalidone , doxazosin , amlodipine , and lisinopril . DESIGN R and omized , double-blind , active-controlled clinical trial , the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial , initiated in February 1994 . In January 2000 , after an interim analysis , an independent data review committee recommended discontinuing the doxazosin treatment arm based on comparisons with chlorthalidone . Therefore , outcomes data presented herein reflect follow-up through December 1999 . SETTING A total of 625 centers in the United States and Canada . PARTICIPANTS A total of 24,335 patients ( aged > or = 55 years ) with hypertension and at least 1 other coronary heart disease ( CHD ) risk factor who received either doxazosin or chlorthalidone . INTERVENTIONS Participants were r and omly assigned to receive chlorthalidone , 12.5 to 25 mg/d ( n=15,268 ) , or doxazosin , 2 to 8 mg/d ( n=9067 ) , for a planned follow-up of 4 to 8 years . MAIN OUTCOME MEASURES The primary outcome measure was fatal CHD or nonfatal myocardial infa rct ion ( MI ) , analyzed by intent to treat ; secondary outcome measures included all-cause mortality , stroke , and combined CVD ( CHD death , nonfatal MI , stroke , angina , coronary revascularization , congestive heart failure [ CHF ] , and peripheral arterial disease ) ; compared by the chlorthalidone group vs the doxazosin group . RESULTS Median follow-up was 3.3 years . A total of 365 patients in the doxazosin group and 608 in the chlorthalidone group had fatal CHD or nonfatal MI , with no difference in risk between the groups ( relative risk [ RR ] , 1.03 ; 95 % confidence interval [ CI ] , 0.90 - 1.17 ; P=.71 ) . Total mortality did not differ between the doxazosin and chlorthalidone arms ( 4-year rates , 9.62 % and 9.08 % , respectively ; RR , 1.03 ; 95 % CI , 0.90 - 1.15 ; P=.56 . ) The doxazosin arm , compared with the chlorthalidone arm , had a higher risk of stroke ( RR , 1.19 ; 95 % CI , 1.01 - 1.40 ; P=.04 ) and combined CVD ( 4-year rates , 25.45 % vs 21.76 % ; RR , 1.25 ; 95 % CI , 1.17 - 1.33 ; P CHF risk was doubled ( 4-year rates , 8.13 % vs 4.45 % ; RR , 2.04 ; 95 % CI , 1.79 - 2.32 ; P RRs for angina , coronary revascularization , and peripheral arterial disease were 1.16 ( P doxazosin , chlorthalidone yields essentially equal risk of CHD death/nonfatal MI but significantly reduces the risk of combined CVD events , particularly CHF , in high-risk hypertensive patients",
"The Heart Protection Study ( HPS ) , with over 20,500 subjects , is the largest trial of statin therapy ever conducted . It provides important and definitive new information on women , the elderly , diabetics , and people with low baseline cholesterol pre-treatment and those with prior occlusive non-coronary vascular disease . It is a prospect i ve double blind r and omised controlled trial with a 2 x 2 factorial design investigating prolonged use ( > 5 years ) of simvastatin 40 mg and a cocktail of antioxidant vitamins ( 650 mg vitamin E , 250 mg vitamin C and 20 mg beta-carotene ) . The HPS specifically included patients with high risk for coronary heart disease ( CHD ) but characteristics that excluded them from participation in previous statin trials . Simvastatin 40 mg treatment showed benefit across all patient groups regardless of age , gender or baseline cholesterol value and proved safe and well tolerated . Results show a 12 % reduction in total mortality , a 17 % reduction in vascular mortality , a 24 % reduction in CHD events , a 27 % reduction in all strokes and a 16 % reduction in non-coronary revascularisations . Among high-risk patients in this western population ( with a minimum total cholesterol [ TC ] > or = 3.5 mmol/l at entry ) there appears to be no threshold cholesterol value below which statin therapy is not associated with benefit ; even among those with pre-treatment cholesterol levels below current national recommended targets . Over the 5.5 year study period patients and their doctors were encouraged to add an active non- study statin to the study regimen if they wished to do so . Thus the trial eventually had only two-thirds complying with the original intention-to-treat design . Nevertheless , results were highly significant for the study statin -- simvastatin 40 mg once daily . Preliminary results of the HPS are negative for the antioxidant vitamin cocktail but provide reassurance that vitamins do no harm",
"BACKGROUND AND PURPOSE The risk of major vascular events after an initial episode of cerebral ischemia in patients with nonrheumatic atrial fibrillation ( NRAF ) varies from 2 % to 15 % in the first year and is approximately 5 % yearly thereafter . Few studies have reported on risk factors that can be used to identify high-risk subgroups within this patient population . METHODS We studied the predictive value of several easily obtainable clinical characteristics in a group of 375 placebo-treated patients with NRAF and a recent episode of transient or nondisabling cerebral ischemia who were entered in a multicenter clinical trial . The mean follow-up was 1.6 years . RESULTS By means of multivariate modeling , six independent variables were identified : history of previous thromboembolism , ischemic heart disease , enlarged cardiothoracic ratio on chest roentgenogram , systolic blood pressure greater than 160 mm Hg at study entry , NRAF for more than 1 year , and presence of an ischemic lesion on CT scan . These variables could also be used to stratify patients in low- , medium- , and high-risk subgroups for the other two arms of the trial , those treated with anticoagulation and aspirin . Patients older than 75 years with three or more risk factors seemingly benefited less from both aspirin and anticoagulant treatment . CONCLUSIONS Easily obtainable patient characteristics are helpful in estimating the potential effect of adequate secondary prevention in patients with NRAF who recently suffered a transient ischemic attack or minor ischemic stroke",
"BACKGROUND In patients with high cholesterol levels , lowering the cholesterol level reduces the risk of coronary events , but the effect of lowering cholesterol levels in the majority of patients with coronary disease , who have average levels , is less clear . METHODS In a double-blind trial lasting five years we administered either 40 mg of pravastatin per day or placebo to 4159 patients ( 3583 men and 576 women ) with myocardial infa rct ion who had plasma total cholesterol levels below 240 mg per deciliter ( mean , 209 ) and low-density lipoprotein ( LDL ) cholesterol levels of 115 to 174 mg per deciliter ( mean , 139 ) . The primary end point was a fatal coronary event or a nonfatal myocardial infa rct ion . RESULTS The frequency of the primary end point was 10.2 percent in the pravastatin group and 13.2 percent in the placebo group , an absolute difference of 3 percentage points and a 24 percent reduction in risk ( 95 percent confidence interval , 9 to 36 percent ; P = 0.003 ) . Coronary bypass surgery was needed in 7.5 percent of the patients in the pravastatin group and 10 percent of those in the placebo group , a 26 percent reduction ( P=0.005 ) , and coronary angioplasty was needed in 8.3 percent of the pravastatin group and 10.5 percent of the placebo group , a 23 percent reduction ( P=0.01 ) . The frequency of stroke was reduced by 31 percent ( P=0.03 ) . There were no significant differences in overall mortality or mortality from noncardiovascular causes . Pravastatin lowered the rate of coronary events more among women than among men . The reduction in coronary events was also greater in patients with higher pretreatment levels of LDL cholesterol . CONCLUSIONS These results demonstrate that the benefit of cholesterol-lowering therapy extends to the majority of patients with coronary disease who have average cholesterol levels",
"To ascertain the appropriate time for detecting lipid abnormalities for prophylaxis , serial analyses of fasting serum lipoproteins were undertaken prospect ively in men with cerebral infa rct ion or transient ischemic attacks . Serum total cholesterol ( T CHOL ) and low density lipoprotein cholesterol ( LDL CHOL ) in cerebral infa rct ion patients aged 50 to 69 were lowest on day 7 , intermediate on day 1 , and highest at 3 months , whereas very low density lipoprotein and high density lipoprotein cholesterol ( HDL CHOL ) changed little . The day 1 mean fasting serum HDL CHOL of cerebral infa rct patients was significantly lower in subjects aged 50 to 59 than in those aged 60 to 69 ( 23 ± 3 versus 42 ± 5 mg/dl ) , and there was a corresponding higher ratio of T CHOL : HDL CHOL ( 12.7 ± 4.5 versus 4.7 ± 0.4 , p were low normal to low in patients aged 50 to 69 with transient ischemic attacks . Both serum cholesterol and triglyceride levels are initially decreased in patients aged 50 to 69 with cerebral infa rct ion , whereas only cholesterol is decreased in patients 60 to 69 with transient ischemic attacks . Important lipoprotein abnormalities may be missed in the acute phase",
"Abstract Objective : To investigate the association between serum cholesterol concentration and cerebrovascular disease . Design : Retrospective study . Setting : Acute stroke unit of inner city general hospital . Subjects : 977 patients with acute stroke . Main outcome measures : Serum total cholesterol concentration , type of stroke investigated by computed tomography or magnetic resonance imaging , three month outcome ( good ( alive at home ) or bad ( dead or in care ) ) , long term mortality . Results : After adjustment for known prognostic factors , higher serum cholesterol concentrations were associated with reduced long term mortality after stroke ( relative hazard 0.91 ( 95 % confidence interval 0.84 to 0.98 ) per mmol/l increase in cholesterol ) independently of stroke type , vascular territory and extent , age , and hyperglycaemia . Three month outcome was also influenced independently by serum cholesterol ( P=0.024 ) . Conclusions : Our data suggest an association between poor stroke outcome and lower serum cholesterol concentration . Until a prospect i ve controlled study has confirmed the benefits of lowering cholesterol concentration in elderly subjects , the application of cholesterol lowering guidelines can not be justified as secondary prevention of acute stroke . Key messages Although the link between cholesterol and stroke is controversial , the balance of evidence suggests higher cholesterol is associated with an increased risk of atherothrombotic stroke but a reduced risk of intracerebral haemorrhage Trials of lipid lowering drugs have concentrated on middle aged patients with a relatively low incidence of stroke events We investigated the association between serum cholesterol and cerebrovascular disease in 977 patients hospitalised with acute stroke and found that higher serum total cholesterol concentrations were associated with a reduction in long term mortality after stroke This relation was independent of the type or extent of the stroke , vascular territory , age , and hyperglycaemia – all factors known to influence survival independently after stroke Until conclusive benefit is shown in elderly patients with cerebrovascular disease , the routine application of lipid lowering treatment after stroke can not be",
"Recent clinical trials of primary and secondary prevention of cardiovascular disease have demonstrated that lowering plasma cholesterol decreases the incidence of coronary heart disease in patients with elevated plasma cholesterol . However , it is not known whether patients with established coronary artery disease and normal plasma cholesterol can be benefited . Several previous prevention trials review ed in this report found that patients who had plasma cholesterol levels at baseline in the upper portion of the eligibility range ( e.g. , greater than 240 mg/dl ) received greater benefit from hypolipidemic diet or drug therapy than patients who had lower plasma cholesterol levels at baseline . The recent availability of drugs that are more potent and less prone to cause adverse reactions than previous regimens permits this important question to be addressed . The Cholesterol and Recurrent Events trial is testing whether pravastatin , a hydroxymethylglutaryl coenzyme A reductase inhibitor , will decrease the sum of fatal coronary heart disease and nonfatal myocardial infa rct ion ( MI ) in patients who have recovered from a MI and who have normal total cholesterol levels . Fatal cardiovascular disease and total mortality are important secondary end points . The trial is enrolling 4,000 men and women from 80 centers throughout North America , age 21 to 75 years , who have survived MI for 3 to 20 months , who have plasma total cholesterol less than 240 mg/dl ( 6.2 mmol/liter ) and low-density cholesterol of 115 to 174 mg/dl ( 3.0 to 4.5 mmol/liter ) , and who are representative of the general population of patients with MI . Patients are r and omized to either active or inactive drug therapy . Active therapy consists of pravastatin , 40 mg/day , design ed to achieve an average decrease in low-density lipoprotein cholesterol of approximately 30 % , and an increase in high-density lipoprotein of 5 % . The average duration of follow-up will be greater than or equal to 5 years . To protect against a lower than expected rate of recurrent events , the trial will be continued until a predetermined fixed number of coronary heart disease events occurs in the entire cohort so that the original sensitivity of the trial will be maintained",
"Abstract A controlled trial of Clofibrate in 95 patients with established cerebral vascular disease is described . The level of serum cholesterol is significantly lowered in patients on treatment compared with control patients . There is no evidence to indicate that lowering the level of serum cholesterol in patients with established cerebral vascular disease has affected either the incidence of further episodes of cerebral ischaemia or the mortality rate",
"We compared stroke severity , risk factors , and prognosis in patients with recurrent versus first-ever stroke . In the Copenhagen Stroke Study , we prospect ively studied 1,138 unselected patients with acute stroke . Stroke was recurrent in 265 ( 23 % ) despite most of these patients being given prophylactic treatment prior to recurrence . Only 12 % of patients with atrial fibrillation were receiving anticoagulant treatment prior to recurrence . In multivariate analysis , recurrence was more frequently associated with a history of TIA , atrial fibrillation , male gender , and hypertension , but not with age , daily alcohol consumption , smoking , diabetes , ischemic heart disease , serum cholesterol , or hematocrit . Mortality was almost doubled compared with patients with a first-ever stroke . In survivors , however , both neurologic and functional outcomes and the speed of recovery were , in general , similar in the two groups . Despite similar neurologic impairments , patients with recurrence contralateral to their first stroke had markedly more severe functional disability after completed rehabilitation than patients with ipsilateral recurrence , implying that the ability to compensate functionally is decreased in patients with contralateral recurrence . Our findings emphasize the importance of consistent anticoagulant treatment for stroke patients with atrial fibrillation and close blood pressure control in stroke patients with hypertension . Other prophylactic measures are needed in patients in whom ASA fails to prevent recurrence . Patients with recurrent stroke have a markedly higher mortality than patients with a first-ever stroke , but those who survive recover as well and as fast as patients with a first-ever stroke . However , if recurrence is contralateral to the first stroke , functional recovery is poorer",
"A cooperative clinical investigation was undertaken in 17 Veterans Administration Hospitals to determine the effects of long-term therapy with conjugated equine estrogens ( Premarin ) in prevention of recurrent cerebral infa rct ion or death due to atherosclerotic vascular disease . To date , 582 men with cerebral infa rct ion have been assigned on a r and om basis to either the treatment or control groups and observed for periods as long as 34 months . Initial treatment consisted of 1.25 mg . of Premarin daily and was increased to 2.5 mg . after the first year . Estrogenic therapy failed to reduce the incidence of either cerebral or myocardial infa rct ion developing during the period of follow-up observation . There was likewise no significant change in the mortality rate following onset of therapy . Of the 63 deaths in the study , 34 occurred in patients receiving treatment and 29 among those receiving the placebo preparation . Approximately 40 per cent of patients developed mild side reactions to the estrogenic agent , usually consisting of breast tenderness or enlargement , or both . These preliminary observations failed to demonstrate that treatment with conjugated equine estrogenic hormones in small and moderate dosages for an average period of 16.7 months had any value in lowering the recurrence of cerebral infa rct ion or reducing the mortality rate subsequent to this disorder",
"CONTEXT Studies have demonstrated that statins administered to individuals with risk factors for coronary heart disease ( CHD ) reduce CHD events . However , many of these studies were too small to assess all-cause mortality or outcomes in important subgroups . OBJECTIVE To determine whether pravastatin compared with usual care reduces all-cause mortality in older , moderately hypercholesterolemic , hypertensive participants with at least 1 additional CHD risk factor . DESIGN AND SETTING Multicenter ( 513 primarily community-based North American clinical centers ) , r and omized , nonblinded trial conducted from 1994 through March 2002 in a subset of participants from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial ( ALLHAT ) . PARTICIPANTS Ambulatory persons ( n = 10 355 ) , aged 55 years or older , with low-density lipoprotein cholesterol ( LDL-C ) of 120 to 189 mg/dL ( 100 to 129 mg/dL if known CHD ) and triglycerides lower than 350 mg/dL , were r and omized to pravastatin ( n = 5170 ) or to usual care ( n = 5185 ) . Baseline mean total cholesterol was 224 mg/dL ; LDL-C , 146 mg/dL ; high-density lipoprotein cholesterol , 48 mg/dL ; and triglycerides , 152 mg/dL. Mean age was 66 years , 49 % were women , 38 % black and 23 % Hispanic , 14 % had a history of CHD , and 35 % had type 2 diabetes . INTERVENTION Pravastatin , 40 mg/d , vs usual care . MAIN OUTCOME MEASURES The primary outcome was all-cause mortality , with follow-up for up to 8 years . Secondary outcomes included nonfatal myocardial infa rct ion or fatal CHD ( CHD events ) combined , cause-specific mortality , and cancer . RESULTS Mean follow-up was 4.8 years . During the trial , 32 % of usual care participants with and 29 % without CHD started taking lipid-lowering drugs . At year 4 , total cholesterol levels were reduced by 17 % with pravastatin vs 8 % with usual care ; among the r and om sample who had LDL-C levels assessed , levels were reduced by 28 % with pravastatin vs 11 % with usual care . All-cause mortality was similar for the 2 groups ( relative risk [ RR ] , 0.99 ; 95 % confidence interval [ CI ] , 0.89 - 1.11 ; P = .88 ) , with 6-year mortality rates of 14.9 % for pravastatin vs 15.3 % with usual care . CHD event rates were not significantly different between the groups ( RR , 0.91 ; 95 % CI , 0.79 - 1.04 ; P = .16 ) , with 6-year CHD event rates of 9.3 % for pravastatin and 10.4 % for usual care . CONCLUSIONS Pravastatin did not reduce either all-cause mortality or CHD significantly when compared with usual care in older participants with well-controlled hypertension and moderately elevated LDL-C. The results may be due to the modest differential in total cholesterol ( 9.6 % ) and LDL-C ( 16.7 % ) between pravastatin and usual care compared with prior statin trials supporting cardiovascular disease prevention",
"BACKGROUND Lower blood cholesterol concentrations have consistently been found to be strongly associated with lower risks of coronary disease but not with lower risks of stroke . Despite this observation , previous r and omised trials had indicated that cholesterol-lowering statin therapy reduces the risk of stroke , but large-scale prospect i ve confirmation has been needed . METHODS 3280 adults with cerebrovascular disease , and an additional 17256 with other occlusive arterial disease or diabetes , were r and omly allocated 40 mg simvastatin daily or matching placebo . Subgroup analyses were prespecified of first \" major vascular event \" ( ie , non-fatal myocardial infa rct ion or coronary death , stroke of any type , or any revascularisation procedure ) in prior disease subcategories . Subsidiary outcomes included any stroke , and stroke sub-type . Comparisons are of all simvastatin-allocated versus all placebo-allocated participants ( ie , \" intention-to-treat \" ) , which yielded an average difference in LDL cholesterol of 1.0 mmol/L ( 39 mg/dL ) during the 5-year treatment period . FINDINGS Overall , there was a highly significant 25 % ( 95 % CI 15 - 34 ) proportional reduction in the first event rate for stroke ( 444 [ 4.3 % ] simvastatin vs 585 [ 5.7 % ] placebo ; p presumed ischaemic strokes ( p strokes attributed to haemorrhage ( 51 [ 0.5 % ] vs 53 [ 0.5 % ] ; rate ratio 0.95 [ 0.65 - 1.40 ] ; p=0.8 ) . In addition , simvastatin reduced the numbers having transient cerebral ischaemic attacks alone ( 2.0 % vs 2.4 % ; p=0.02 ) or requiring carotid endarterectomy or angioplasty ( 0.4 % vs 0.8 % ; p=0.0003 ) . The reduction in stroke was not significant during the first year , but was already significant ( p=0.0004 ) by the end of the second year . Among patients with pre-existing cerebrovascular disease there was no apparent reduction in the stroke rate , but there was a highly significant 20 % ( 8 - 29 ) reduction in the rate of any major vascular event ( 406 [ 24.7 % ] vs 488 [ 29.8 % ] ; p=0.001 ) . The proportional reductions in stroke were about one-quarter in each of the other subcategories of participant studied , including : those with coronary disease or diabetes ; those aged under or over 70 years at entry ; and those presenting with different levels of blood pressure or lipids ( even when the pretreatment LDL cholesterol was below 3.0 mmol/L [ 116 mg/dL ] ) . INTERPRETATION Much larger numbers of people in the present study suffered a stroke than in any previous cholesterol-lowering trial . The results demonstrate that statin therapy rapidly reduces the incidence not only of coronary events but also of ischaemic strokes , with no apparent effect on cerebral haemorrhage , even among individuals who do not have high cholesterol concentrations . Allocation to 40 mg simvastatin daily reduced the rate of ischaemic strokes by about one-quarter and so , after making allowance for non-compliance in the trial , actual use of this regimen would probably reduce the stroke rate by about a third . HPS also provides definitive evidence that statin therapy is beneficial for people with pre-existing cerebrovascular disease , even if they do not already have manifest coronary disease",
"BACKGROUND Statins reduce the incidence of strokes among patients at increased risk for cardiovascular disease ; whether they reduce the risk of stroke after a recent stroke or transient ischemic attack ( TIA ) remains to be established . METHODS We r and omly assigned 4731 patients who had had a stroke or TIA within one to six months before study entry , had low-density lipoprotein ( LDL ) cholesterol levels of 100 to 190 mg per deciliter ( 2.6 to 4.9 mmol per liter ) , and had no known coronary heart disease to double-blind treatment with 80 mg of atorvastatin per day or placebo . The primary end point was a first nonfatal or fatal stroke . RESULTS The mean LDL cholesterol level during the trial was 73 mg per deciliter ( 1.9 mmol per liter ) among patients receiving atorvastatin and 129 mg per deciliter ( 3.3 mmol per liter ) among patients receiving placebo . During a median follow-up of 4.9 years , 265 patients ( 11.2 percent ) receiving atorvastatin and 311 patients ( 13.1 percent ) receiving placebo had a fatal or nonfatal stroke ( 5-year absolute reduction in risk , 2.2 percent ; adjusted hazard ratio , 0.84 ; 95 percent confidence interval , 0.71 to 0.99 ; P=0.03 ; unadjusted P=0.05 ) . The atorvastatin group had 218 ischemic strokes and 55 hemorrhagic strokes , whereas the placebo group had 274 ischemic strokes and 33 hemorrhagic strokes . The five-year absolute reduction in the risk of major cardiovascular events was 3.5 percent ( hazard ratio , 0.80 ; 95 percent confidence interval , 0.69 to 0.92 ; P=0.002 ) . The overall mortality rate was similar , with 216 deaths in the atorvastatin group and 211 deaths in the placebo group ( P=0.98 ) , as were the rates of serious adverse events . Elevated liver enzyme values were more common in patients taking atorvastatin . CONCLUSIONS In patients with recent stroke or TIA and without known coronary heart disease , 80 mg of atorvastatin per day reduced the overall incidence of strokes and of cardiovascular events , despite a small increase in the incidence of hemorrhagic stroke . ( Clinical Trials.gov number , NCT00147602 [ Clinical Trials.gov ] . )",
"Evidence suggests that statin therapy reduces the risk of stroke in patients with coronary heart disease ( CHD ) , but its benefit for patients with cerebrovascular disease and no history of CHD remains uncertain . The Stroke Prevention by Aggressive Reduction in Cholesterol Levels ( SPARCL ) Study is a prospect i ve , multi-centre , double-blind , r and omised , placebo-controlled trial design ed to evaluate the effects of atorvastatin 80 mg/day in patients who previously experienced a stroke or transient ischaemic attack , but who have no known CHD . A total of 4,732 patients have been enrolled , and the data collection phase of the study is expected to be completed by October 2004 . SPARCL is the first study primarily design ed to prospect ively evaluate the effect of statin treatment in secondary stroke prevention"
] | 4116356c-06ff-11f0-808a-c43d1ab1c353 |
Background The ActivityStat hypothesis suggests that when physical activity is increased or decreased in one domain , there will be a compensatory change in another domain , in order to maintain an overall stable level of physical activity or energy expenditure over time . The ActivityStat debate is gaining momentum in the literature and most of the research to date is based on observational studies . Objective The objective of this paper is to conceptually clarify the ActivityStat hypothesis and to examine the experimental research aim ing to demonstrate or refute compensation using a systematic review process . Methods A systematic review was conducted using electronic data base search es with the aim of detecting studies experimentally investigating the ActivityStat hypothesis or compensation in physical activity or energy expenditure . Included studies were critically appraised using a specifically design ed tool to address the conceptual considerations of the ActivityStat hypothesis . Results Search es identified 28 studies that met the inclusion criteria . Publications spanned 26 years and had multiple method ological approaches , including r and omized and non-r and omized controlled trials , crossover design s , cluster r and omized controlled trials and pre-post trials . Population s of the included studies ranged from children , to adults and the elderly , across a range of weight statuses and used both aerobic , resistance and mixed-exercise interventions . The timeframe of interventions ranged from 1 day to 4 years and outcomes were measured using doubly labelled water , accelerometry , heart rate monitoring , resting metabolic rate , indirect calorimetry , pedometry , subjective recall question naire and the activity-related time index . Fifteen of 28 included studies provided evidence of compensation , while 13 did not . Subgroup analyses by population , type and duration of intervention , weight status and study quality also showed mixed findings . Conclusion There is a substantial body of experimental literature investigating compensation that has largely been overlooked in the ActivityStat debate . However , this evidence is currently inconclusive and lacks a cohesive approach to the question of an ActivityStat . Recommendations for the design of future experimental research investigating the ActivityStat hypothesis are presented | [
"The effect of aerobic exercise on dietary compliance was assessed in 13 obese women ( 44 + /- 3 % fat ) during a 12-wk weight-reduction program ( EX group ) . Seventeen obese women ( 45 + /- 5 % fat ) not engaged in aerobic exercise ( NX group ) served as control subjects . The reducing diets were design ed to promote a weight loss of 1 kg/wk , with energy intakes individually prescribed ( mean + /- SD : 4.9 + /- 0.6 MJ/d ) to approximate 75 % of each subject 's measured basal metabolic rate . The EX group completed of three 45-min sessions/wk of supervised aerobic exercise at 65 % of maximal oxygen consumption ( VO2max ) . Daily energy intakes were calculated by summing changes in body stores , measured by total body water isotope dilution , and total daily energy expenditure , measured by doubly labeled water ( DLW ) . Dietary compliance was assessed by comparing calculated intakes with prescribed intakes . Both the EX and NX groups reported consuming close to their prescribed daily intakes , with differences of -0.08 + /- 0.28 ( EX group ) and + 0.03 + /- 0.57 ( NX group ) MJ/d , respectively . However , expenditure/balance data determined by the DLW method indicated that the EX subjects exhibited better dietary compliance than the NX subjects , with intakes exceeding those prescribed by only 0.7 + /- 1.5 compared with 2.3 + /- 1.6 MJ/d for the NX subjects ( P = 0.01 ) . Therefore , an additional benefit of aerobic exercise during energy restriction is enhanced dietary compliance , which has important implication s for the treatment of moderate obesity",
"The effects of severe energy restriction alone ( 2.0 MJ/d for 4 wk and subsequently 3.5 MJ/d for 4 wk ) or energy restriction plus moderate exercise on energy balance were studied in 20 healthy obese women . Subjects aged 25 - 50 y were matched on the basis of body mass index and percentage body fat and r and omly assigned to diet alone ( D ) or diet and exercise ( DE ) for 8 wk . DE result ed in a significantly increased loss of fat mass compared with D ( 7.8 + /- 0.8 compared with 5.5 + /- 0.8 kg ; P average daily metabolic rate measured with doubly labeled water decreased with both treatments , with no differences between the treatments . Energy balance data show that the DE treatment result ed in a significantly greater energy deficit than the D treatment . The relative contribution of fat to energy expenditure during exercise was significantly enhanced by DE treatment whereas it did not change after D. The energy expended on physical activity was not changed at the end of both treatments , with no differences between the two groups . The unchanged energy expended on physical activity indicates that DE might be accompanied by partial compensation of daily physical activities outside the training for the energy expended during the training . The energy deficit due to energy restriction alone was not compensated by a decrease in free-living daily physical activities . Addition of moderate exercise to an energy-restriction program in obese women has advantages with respect to changes in body composition , energy expenditure , and substrate utilization",
"Objective : To assess the efficacy of a school-based intervention programme to reduce the prevalence of overweight in 6 to 10-year-old children . Design : Cluster-r and omized , controlled study .Subjects : A total of 3135 boys and girls in grade s 1–4 were included in the study . Methods : Ten schools were selected in Stockholm county area and r and omized to intervention ( n=5 ) and control ( n=5 ) schools . Low-fat dairy products and whole-grain bread were promoted and all sweets and sweetened drinks were eliminated in intervention schools . Physical activity ( PA ) was aim ed to increase by 30 min day−1 during school time and sedentary behaviour restricted during after school care time . PA was measured by accelerometry . Eating habits at home were assessed by parental report . Eating disorders were evaluated by self-report . Results : The prevalence of overweight and obesity decreased by 3.2 % ( from 20.3 to 17.1 ) in intervention schools compared with an increase of 2.8 % ( from 16.1 to 18.9 ) in control schools ( P analysis of BMI sds changes . However , a larger proportion of the children who were initially overweight reached normal weight in the intervention group ( 14 % ) compared with the control group ( 7.5 % ) , P=0.017 . PA did not differ between intervention and control schools after cluster adjustment . Eating habits at home were found to be healthier among families with children in intervention schools at the end of the intervention . There was no difference between children in intervention and control schools in self-reported eating disorders . Conclusions : A school-based intervention can reduce the prevalence of overweight and obesity in 6 to 10-year-old children and may affect eating habits at home . The effect of the intervention was possibly due to its effect on healthy eating habits at school and at home rather than on increased levels of PA ",
"Objective To assess the effectiveness of a school based physical activity programme during one school year on physical and psychological health in young schoolchildren . Design Cluster r and omised controlled trial . Setting 28 classes from 15 elementary schools in Switzerl and r and omly selected and assigned in a 4:3 ratio to an intervention ( n=16 ) or control arm ( n=12 ) after stratification for grade ( first and fifth grade ) , from August 2005 to June 2006 . Participants 540 children , of whom 502 consented and presented at baseline . Intervention Children in the intervention arm ( n=297 ) received a multi-component physical activity programme that included structuring the three existing physical education lessons each week and adding two additional lessons a week , daily short activity breaks , and physical activity homework . Children ( n=205 ) and parents in the control group were not informed of an intervention group . For most outcome measures , the assessors were blinded . Main outcome measures Primary outcome measures included body fat ( sum of four skinfolds ) , aerobic fitness ( shuttle run test ) , physical activity ( accelerometry ) , and quality of life ( question naires ) . Secondary outcome measures included body mass index and cardiovascular risk score ( average z score of waist circumference , mean blood pressure , blood glucose , inverted high density lipoprotein cholesterol , and triglycerides ) . Results 498 children completed the baseline and follow-up assessment s ( mean age 6.9 ( SD 0.3 ) years for first grade , 11.1 ( 0.5 ) years for fifth grade ) . After adjustment for grade , sex , baseline values , and clustering within classes , children in the intervention arm compared with controls showed more negative changes in the z score of the sum of four skinfolds ( −0.12 , 95 % confidence interval −0.21 to −0.03 ; P=0.009 ) . Likewise , their z scores for aerobic fitness increased more favourably ( 0.17 , 0.01 to 0.32 ; P=0.04 ) , as did those for moderate-vigorous physical activity in school ( 1.19 , 0.78 to 1.60 ; P ( 0.44 , 0.05 to 0.82 ; P=0.03 ) , and total physical activity in school ( 0.92 , 0.35 to 1.50 ; P=0.003 ) . Z scores for overall daily physical activity ( 0.21 , −0.21 to 0.63 ) and physical quality of life ( 0.42 , −1.23 to 2.06 ) as well as psychological quality of life ( 0.59 , −0.85 to 2.03 ) did not change significantly . Conclusions A school based multi-component physical activity intervention including compulsory elements improved physical activity and fitness and reduced adiposity in children . Trial registration Current Controlled Trials IS RCT N15360785",
"Abstract Opportunities for children to be physically active during school time are sparse and becoming increasingly so . The purpose of this investigation was to determine if children would compensate for school days ( 9 a.m.–3 p.m. ) of restricted physical activity opportunities by increasing activity levels after school ( 3 p.m.–7:30 p.m. ) . Third and fourth grade children ( N = 76 ) each wore a CSA accelerometer for 4 nonconsecutive days . Two days were categorized as active — during school , all children participated in outdoor recess and physical education class . Two days were categorized as restricted — all children spent their recess time indoors at a computer terminal , and no physical education class was scheduled . Dependent t tests revealed that children did not compensate for a sedentary school day by increasing their levels of physical activity after school . In fact , average movement counts per minute were higher in the 3 p.m.–7:30 p.m. period following the active day ( 525 counts·min−1 ) versus the restricted day ( 186 counts·min−1 ) . These findings suggest cause for concern if children 's opportunities to be active within school time are limited . Several reasons are given as to why children did not compensate or “ make up ” for the physical activity opportunities missed during the restricted school day",
"INTRODUCTION We examined the effects of three exercise training interventions on total physical activity energy expenditure ( PAEE ) or nonexercise PAEE in a r and omized controlled trial where sedentary , overweight , and obese men and women were assigned to inactive control , low-amount/moderate-intensity , low-amount/vigorous-intensity , or high-amount/vigorous-intensity aerobic exercise . METHODS To measure PAEE , triaxial RT3 accelerometers were worn by subjects for 7 d at the beginning and end of an 8-month exercise intervention . In total , 50 subjects ( control , n = 8 ; two low-amount groups , n = 28 ; high-amount group , n = 14 ) had usable PAEE data collected at both time points . RESULTS At baseline , subjects had an average age of 53.2 yr , had a body mass index of 29.7 kg x m(-2 ) , and a relative peak VO2 of 28.7 mL x kg(-1 ) x min(-1 ) . There were no significant differences between groups at baseline . After the intervention , average change in total PAEE was 8.4 + /- 20.9 kJ x h(-1 ) for controls , 58.6 + /- 20.9 kJ x h(-1 ) for the two low-amount groups , and 138.1 + /- 33.5 kJ x h(-1 ) for the high-amount group ( means + /- SE ) . The high-amount group experienced a significantly greater increase in total PAEE compared with the controls ( P = 0.02 ) . As expected , total PAEE increased with increasing exercise volume . Average change in nonexercise PAEE was 8.4 + /- 20.9 kJ x h(-1 ) for control , 25.1 + /- 20.9 kJ x h(-1 ) for the low-amount groups combined , and 62.8 + /- 29.3 kJ x h(-1 ) for the high-amount group . There was no statistically significant difference in change of nonexercise PAEE among groups . CONCLUSIONS We conclude that in middle-aged overweight or obese subjects participating in an extended exercise intervention , total PAEE increased , and there was no compensatory decrease in nonexercise PAEE",
"OBJECTIVES This study evaluated a health-related physical education program for fourth- and fifth- grade students design ed to increase physical activity during physical education classes and outside of school . METHODS Seven schools were assigned to three conditions in a quasi-experimental design . Health-related physical education was taught by physical education specialists or trained classroom teachers . Students from these classes were compared with those in control classes . Analyses were conducted on 955 students with complete data . RESULTS Students spent more minutes per week being physically active in specialist-led ( 40 min ) and teacher-led ( 33 min ) physical education classes than in control classes ( 18 min ; P specialist-led condition were superior to girls in the control condition on abdominal strength and endurance ( P cardiorespiratory endurance ( P physical activity outside of school . CONCLUSIONS A health-related physical education curriculum can provide students with substantially more physical activity during physical education classes . Improved physical education classes can potentially benefit 97 % of elementary school students",
"BACKGROUND In light of the current obesity epidemic , treatment models are needed that can prevent weight gain or provide weight loss . We examined the long-term effects of a supervised program of moderate-intensity exercise on body weight and composition in previously sedentary , overweight and moderately obese men and women . We hypothesized that a 16-month program of verified exercise would prevent weight gain or provide weight loss in the exercise group compared with controls . METHODS This was a r and omized controlled efficacy trial . Participants were recruited from 2 midwestern universities and their surrounding communities . One hundred thirty-one participants were r and omized to exercise or control groups , and 74 completed the intervention and all laboratory testing . Exercise was supervised , and the level of energy expenditure of exercise was measured . Controls remained sedentary . All participants maintained ad libitum diets . RESULTS Exercise prevented weight gain in women and produced weight loss in men . Men in the exercise group had significant mean + /- SD decreases in weight ( 5.2 + /- 4.7 kg ) , body mass index ( calculated as weight in kilograms divided by the square of height in meters ) ( 1.6 + /- 1.4 ) , and fat mass ( 4.9 + /- 4.4 kg ) compared with controls . Women in the exercise group maintained baseline weight , body mass index , and fat mass , and controls showed significant mean + /- SD increases in body mass index ( 1.1 + /- 2.0 ) , weight ( 2.9 + /- 5.5 kg ) , and fat mass ( 2.1 + /- 4.8 kg ) at 16 months . No significant changes occurred in fat-free mass in either men or women ; however , both had significantly reduced visceral fat . CONCLUSIONS Moderate-intensity exercise sustained for 16 months is effective for weight management in young adults ",
"Effects of progressive endurance training on energy expenditure ( EE ) were studied in thirteen elderly sedentary subjects ( 62.8 ( SD 2.3 ) years ) after 7 and 14 weeks of training . Daily EE ( DEE ) and energy cost of the various usual activities were measured over 48 h by whole-body indirect calorimetry . Free-living DEE ( DEEFLC ) was calculated from 7 d activity recordings and the energy costs of activities were measured in the calorimeters using the factorial method . DEEFLC did not vary significantly throughout the training period despite the additional energy cost of training sessions ( 0.60 ( SD 0.15 ) MJ/d ) , because energy expended during free-living activities ( EEACT ) decreased by 4.8 ( SD 7.1)% ( P sleeping metabolic rate transiently increased by 4.6 ( SD 3.2)% after 7 weeks of training ( P BMR was 7.6 ( SD 7.0)% ( P diet-induced thermogenesis increased from 3.7 ( SD 2.5 ) to 7.2 ( SD 2.8)% energy intake after 7 weeks of training ( P energy expended during activities and the corresponding DEE did not vary throughout the training period . It was concluded that : ( 1 ) DEEFLC remained constant throughout the training period due to a compensatory decrease in free-living EEACT ; ( 2 ) progressive endurance training induced a transient increase in sleeping metabolic rate , BMR and diet-induced thermogenesis after 7 weeks which was not reflected in the energy expended during activities and DEE",
"The decline in physical activity with age may be the most consistent finding in physical activity epidemiology . Although this phenomenon is well accepted , it is not well understood . The purpose s of this symposium are to determine whether there are critical periods of decline and quantify sex differences in the decline . Data from cross-sectional and prospect i ve studies indicate the decline is steepest between the ages of 13 and 18 . The decline is generally greater for male than female subjects , and the decline varies by type and intensity of the activity . A review of animal studies documented the age-related decline in many species . This suggests a biological basis , and a probable mechanism is the dopamine system that regulates motivation for locomotion . The decline in physical activity with age is antithetical to public health goals , so methods of countering the decline need to be developed , based upon an improved underst and ing of the phenomenon and its causes",
"The effects of adding exercise to diet for weight control in obese children were evaluated by r and omizing obese girls to one of two groups : diet and diet plus exercise . During the first 6 weeks of the treatment , children exercised in a supervised three times a week exercise program , in which they walked or ran 3 miles . Significant decreases from baseline weight and in percent overweight were observed for both groups during the year of treatment . Significant decreases in percent overweight were observed at 0 to 2 months and then at 2 to 6 months for the children who were exercising , whereas percent overweight in children in the diet-alone group decreased only from 0 to 2 months . In addition , a significant improvement in fitness was observed only for children in the diet plus exercise group",
"BACKGROUND Exercise interventions elicit only modest weight loss , which might reflect a compensatory reduction in nonprescribed physical activity energy expenditure ( PAEE ) . OBJECTIVE The objective was to investigate whether there is a reduction in nonprescribed PAEE as a result of participation in a 6-mo structured exercise intervention in middle-aged men . DESIGN Sedentary male participants [ age : 54 ± 5 y ; body mass index ( in kg/m² ) : 28 ± 3 ] were r and omly assigned to a 6-mo progressive exercise ( EX ) or control ( CON ) group . Energy expenditure during structured exercise ( prescribed PAEE ) and nonprescribed PAEE were determined with the use of synchronized accelerometry and heart rate before the intervention , during the intervention ( 2 , 9 , and 18 wk ) , and within a 2-wk period of detraining after the intervention . RESULTS Structured prescribed exercise increased total PAEE and had no detrimental effect on nonprescribed PAEE . Indeed , there was a trend for greater nonprescribed PAEE in the EX group ( P = 0.09 ) . Weight loss in the EX group ( -1.8 ± 2.2 kg compared with + 0.2 ± 2.2 kg in the CON group , P exercise . Serum leptin concentration decreased by 24 % in the EX group ( compared with 3 % in the CON group , P increase in energy intake of ≈100 kcal/d . CONCLUSIONS The adoption of regular structured exercise in previously sedentary , middle-aged , and overweight men does not result in a negative compensatory reduction in nonprescribed physical activity . The less-than-predicted weight loss is likely to reflect a compensatory increase in energy intake in response to a perceived state of relative energy insufficiency"
] | 411635a8-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Atrial fibrillation ( AF ) , the most common arrhythmia in clinical practice , is a leading cause of morbidity and mortality . Screening for AF in asymptomatic patients has been proposed as a way of reducing the burden of the disease by detecting people who would benefit from prophylactic anticoagulation therapy before the onset of symptoms . However , for screening to be an effective intervention , it must improve the detection of AF and provide benefit for those detected earlier as a result of screening . OBJECTIVES This review aims to answer the following questions .Does systematic screening increase the detection of AF compared with routine practice ? Which combination of screening population , strategy and test is most effective for detecting AF compared with routine practice ? What safety issues and adverse events may be associated with individual screening programmes ? How acceptable is the intervention to the target population ? What costs are associated with systematic screening for AF ? SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL ) , MEDLINE ( Ovid ) and EMBASE ( Ovid ) up to 11 November 2015 . We search ed other relevant research data bases , trials registries and websites up to December 2015 . We also search ed reference lists of identified studies for potentially relevant studies , and we contacted corresponding authors for information about additional published or unpublished studies that may be relevant . We applied no language restrictions . SELECTION CRITERIA R and omised controlled trials comparing screening for AF with routine practice in people 40 years of age and older were eligible . Two review authors ( PM and CT ) independently selected trials for inclusion . DATA COLLECTION AND ANALYSIS Two review authors ( PM and CT ) independently assessed risk of bias and extracted data . We used odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) to present results for the primary outcome , which is a dichotomous variable . As we identified only one study for inclusion , we performed no meta- analysis . We used the GRADE ( Grade s of Recommendation , Assessment , Development and Evaluation Working Group ) method to assess the quality of the evidence and GRADE Pro to create a ' Summary of findings ' table . MAIN RESULTS One cluster-r and omised controlled trial met the inclusion criteria for this review . This study compared systematic screening ( by invitation to have an electrocardiogram ( ECG ) ) and opportunistic screening ( pulse palpation during a general practitioner ( GP ) consultation for any reason , followed by an ECG if pulse was irregular ) versus routine practice ( normal case finding on the basis of clinical presentation ) in people 65 years of age or older . Results show that both systematic screening and opportunistic screening of people over 65 years of age are more effective than routine practice ( OR 1.57 , 95 % CI 1.08 to 2.26 ; and OR 1.58 , 95 % CI 1.10 to 2.29 , respectively ; both moderate- quality evidence ) . We found no difference in the effectiveness of systematic screening and opportunistic screening ( OR 0.99 , 95 % CI 0.72 to 1.37 ; low- quality evidence ) . A subgroup analysis found that systematic screening and opportunistic screening were more effective in men ( OR 2.68 , 95 % CI 1.51 to 4.76 ; and OR 2.33 , 95 % CI 1.29 to 4.19 , respectively ) than in women ( OR 0.98 , 95 % CI 0.59 to 1.62 ; and OR 1.2 , 95 % CI 0.74 to 1.93 , respectively ) . No adverse events associated with screening were reported . The incremental cost per additional case detected by opportunistic screening was GBP 337 , compared with GBP 1514 for systematic screening . All cost estimates were based on data from the single included trial , which was conducted in the UK between 2001 and 2003 . AUTHORS ' CONCLUSIONS Evidence suggests that systematic screening and opportunistic screening for AF increase the rate of detection of new cases compared with routine practice . Although these approaches have comparable effects on the overall AF diagnosis rate , the cost of systematic screening is significantly greater than the cost of opportunistic screening from the perspective of the health service provider . Few studies have investigated effects of screening in other health systems and in younger age groups ; therefore , caution needs to be exercised in relation to transferability of these results beyond the setting and population in which the included study was conducted . Additional research is needed to examine the effectiveness of alternative screening strategies and to investigate the effects of the intervention on risk of stroke for screened versus non-screened population | [
"BACKGROUND To test the use of three lead monitoring as a screening tool for atrial fibrillation ( AF ) in general practice . AF is responsible for up to a quarter of all strokes and is often asymptomatic until a stroke occurs . METHODS 26 r and omly selected general practice s identified 80 r and omly selected patients aged 70 or older from their data base and excluded those known to have AF , those with clinical issues or who had not attended for three years . Up to 40 eligible patients / practice were invited to attend for screening . A 2min three-lead ECG was recorded and collected central ly for expert cardiology assessment . Risk factor data was gathered . OUTCOMES ( i ) point prevalence of AF , ( ii ) proportion of ECG tracings which were adequate for interpretation , ( iii ) uptake rate by patients and ( iv ) acceptability of the screening process to patients and staff ( reported separately ) . RESULTS Of 1447 current patients , 1003 were eligible for inclusion , 639 ( 64 % ) agreed to take part in screening and 566 ( 56 % ) completed screening . The point prevalence rate for AF was 10.3%-2.1 % new cases ( 12 of 566 who were screened ) and 9.5 % existing cases ( 137 of 1447 eligible patients ) . Only four of 570 ( 0.7 % ) screening visits did not record a usable ECG and 11 ( 2.6 % ) three lead ECGs required a clarifying 12 lead ECG . CONCLUSIONS Three lead screening for AF is feasible , effective and offers an alternative to pulse taking or 12 lead ECGs . The availability of this technology may facilitate more effective screening , leading to reduced stroke incidence",
"Objectives To assess whether screening improves the detection of atrial fibrillation ( cluster r and omisation ) and to compare systematic and opportunistic screening . Design Multicentred cluster r and omised controlled trial , with subsidiary trial embedded within the intervention arm . Setting 50 primary care centres in Engl and , with further individual r and omisation of patients in the intervention practice s. Participants 14 802 patients aged 65 or over in 25 intervention and 25 control practice s. Interventions Patients in intervention practice s were r and omly allocated to systematic screening ( invitation for electrocardiography ) or opportunistic screening ( pulse taking and invitation for electrocardiography if the pulse was irregular ) . Screening took place over 12 months in each practice from October 2001 to February 2003 . No active screening took place in control practice s. Main outcome measure Newly identified atrial fibrillation . Results The detection rate of new cases of atrial fibrillation was 1.63 % a year in the intervention practice s and 1.04 % in control practice s ( difference 0.59 % , 95 % confidence interval 0.20 % to 0.98 % ) . Systematic and opportunistic screening detected similar numbers of new cases ( 1.62 % v 1.64 % , difference 0.02 % , −0.5 % to 0.5 % ) . Conclusion Active screening for atrial fibrillation detects additional cases over current practice . The preferred method of screening in patients aged 65 or over in primary care is opportunistic pulse taking with follow-up electrocardiography . Trial registration Current Controlled Trials IS RCT N19633732",
"Background Atrial fibrillation ( AF ) has been recognised as an important independent risk factor for thromboembolic disease , particularly stroke for which it provides a five-fold increase in risk . This study aim ed to determine the baseline prevalence and the incidence of AF based on a variety of screening strategies and in doing so to evaluate the incremental cost-effectiveness of different screening strategies , including targeted or whole population screening , compared with routine clinical practice , for detection of AF in people aged 65 and over . The value of clinical assessment and echocardiography as additional methods of risk stratification for thromboembolic disease in patients with AF were also evaluated . Methods The study design was a multi-centre r and omised controlled trial with a study population of patients aged 65 and over from 50 General Practice s in the West Midl and s. These purpose fully selected general practice s were r and omly allocated to 25 intervention practice s and 25 control practice s. GPs and practice nurses within the intervention practice s received education on the importance of AF detection and ECG interpretation . Patients in the intervention practice s were r and omly allocated to systematic ( n = 5000 ) or opportunistic screening ( n = 5000 ) . Prospect i ve identification of pre-existing risk factors for AF within the screened population enabled comparison between high risk targeted screening and total population screening . AF detection rates in systematic ally screened and opportunistically screened population s in the intervention practice s were compared to AF detection rate in 5,000 patients in the control practice ",
"BACKGROUND Heart failure and stroke are major causes of morbidity and mortality in older people . Angiotensin converting enzyme inhibitors improve symptoms and survival in left ventricular systolic dysfunction . Anticoagulants are effective in stroke prevention in atrial fibrillation with aspirin being a less effective alternative . OBJECTIVES To determine the prevalence of left ventricular systolic dysfunction , health services utilisation and prescribing of diuretics and angiotensin converting enzyme inhibitors in left ventricular systolic dysfunction , and the prevalence of atrial fibrillation and anti-platelet/thrombotic therapy in atrial fibrillation in older people in the community . METHODS 500 subjects were drawn by two-stage r and om sampling from 5,002 subjects aged 70 years and over living at home . Subjects were screened for atrial fibrillation and left ventricular systolic dysfunction using electrocardiography and echocardiography . RESULTS The population prevalence amongst older people of left ventricular systolic dysfunction was 9.8 % and of atrial fibrillation 7.8 % . More than two-thirds of those with left ventricular systolic dysfunction were not on angiotensin converting enzyme inhibitors . Of those in atrial fibrillation , 35 % were taking aspirin , 24 % were taking warfarin and 41 % were on neither aspirin nor warfarin . Nearly 90 % of older people in the community have had contact with their general practitioner over the past year , and over half of those with left ventricular systolic dysfunction have had contact with hospital-based services over the past 2 years . CONCLUSIONS Left ventricular systolic dysfunction is under-treated in older people in the community . Despite the high level of contact with hospital and community-based services , the majority of those with systolic left ventricular dysfunction are not on angiotensin converting enzyme inhibitors and a significant proportion of those in atrial fibrillation are not on any treatment for stroke prevention",
"Objective To assess the accuracy of general practitioners , practice nurses , and interpretative software in the use of different types of electrocardiogram to diagnose atrial fibrillation . Design Prospect i ve comparison with reference st and ard of assessment of electrocardiograms by two independent specialists . Setting 49 general practice s in central Engl and . Participants 2595 patients aged 65 or over screened for atrial fibrillation as part of the screening for atrial fibrillation in the elderly ( SAFE ) study ; 49 general practitioners and 49 practice nurses . Interventions All electrocardiograms were read with the Biolog interpretative software , and a r and om sample of 12 lead , limb lead , and single lead thoracic placement electrocardiograms were assessed by general practitioners and practice nurses independently of each other and of the Biolog assessment . Main outcome measures Sensitivity , specificity , and positive and negative predictive values . Results General practitioners detected 79 out of 99 cases of atrial fibrillation on a 12 lead electrocardiogram ( sensitivity 80 % , 95 % confidence interval 71 % to 87 % ) and misinterpreted 114 out of 1355 cases of sinus rhythm as atrial fibrillation ( specificity 92 % , 90 % to 93 % ) . Practice nurses detected a similar proportion of cases of atrial fibrillation ( sensitivity 77 % , 67 % to 85 % ) , but had a lower specificity ( 85 % , 83 % to 87 % ) . The interpretative software was significantly more accurate , with a specificity of 99 % , but missed 36 of 215 cases of atrial fibrillation ( sensitivity 83 % ) . Combining general practitioners ' interpretation with the interpretative software led to a sensitivity of 92 % and a specificity of 91 % . Use of limb lead or single lead thoracic placement electrocardiograms result ed in some loss of specificity . Conclusions Many primary care professionals can not accurately detect atrial fibrillation on an electrocardiogram , and interpretative software is not sufficiently accurate to circumvent this problem , even when combined with interpretation by a general practitioner . Diagnosis of atrial fibrillation in the community needs to factor in the reading of electrocardiograms by appropriately trained people",
"AIMS Atrial fibrillation ( AF ) is a major cause of morbidity , mortality , and health re source consumption . However , as many patients with chronic AF are asymptomatic , rapid , accurate opportunistic screening is needed in primary care to detect AF . Conventional electrocardiogram ( ECG ) technology is too clumsy and time consuming for mass opportunistic screening , thus technology that allows easy , rapid , yet accurate AF screening is required . To address this requirement a prototype h and -held electrode assembly was developed . We hypothesized that a 6-lead frontal-plane ECG acquired from this apparatus in a seated , clothed patient would be as accurate at detecting AF as conventional 12-lead ECG in the undressed , supine patient ( the ' gold st and ard ' ) . METHODS AND RESULTS Electrocardiograms were obtained from 78 patients with AF and 79 with sinus rhythm ( SR ) . All had a conventional 12-lead ECG , a 6-lead ECG from conventionally positioned limb electrodes , a supine 6-lead recording using the prototype recorder placed on the lower thorax/upper abdomen , and a 6-lead prototype recording in the seated patient , the latter with loosened clothing only . Electrocardiograms were r and omly and blindly assessed by two cardiologists for ( i ) diagnosis of AF vs. SR and ( ii ) tracing quality ( subjectively assessed as good , adequate , or bad ) . Compared with conventional 12-lead ECG recordings , all ' new ' recording methods performed satisfactorily with sensitivities ≥90 % ( 90 - 99 % ) , specificities ≥94 % ( 94 - 100 % ) , positive predictive values ≥94 % ( 94 - 100 % ) , negative predictive values ≥90 % ( 90 - 99 % ) , and accuracies ≥93 % ( 93 - 99 % ) . Tracing quality was higher in conventional 12-lead recordings ( 71 and 80 % were assessed as good by the two observers ) compared with conventional 6-lead ( 57 and 59 % ) , supine prototype ( 41 and 31 % ) , and sitting prototype ( 39 and 19 % ) . CONCLUSIONS Despite inferior electrocardiographic quality a 6-lead frontal plane ECG acquired by a simple prototype h and -held electrode assembly allowed reliable differentiation of AF from SR compared with st and ard 12-lead ECG",
"Objectives : To assess the demographic and psychological mediators of gender differences in uptake of flexible sigmoidoscopy ( FS ) screening for colorectal cancer . Setting : A sub sample ( n=5462 ) from a large community trial of FS in the UK . Methods : Men and women r and omized to screening as part of the UK Flexible Sigmoidoscopy Trial were sent a postal question naire assessing demographic characteristics and attitudes to screening six months before their screening appointment . Attendance at screening was recorded by the screening centres . Results : More men than women attended screening ( 73 % versus 67 % ) . The higher male attendance was partially explained by their lower levels of socioeconomic deprivation , higher levels of marital status and lower perceived barriers to screening . Conclusions : Contrary to expectations , men weremore likely than women to attend FS screening . This was partially explained by socioeconomic and attitudinal differences to screening , but additional research is needed to underst and the key aspects of FS screening that will maximize screening uptake in men and women",
"Background : Atrial fibrillation is a common arrhythmia associated with excess morbidity and mortality . We studied temporal changes in hospital admission rates for atrial fibrillation using data from a prospect i ve population -based cohort study spanning 2 decades ( the Copenhagen City Heart Study ) . Methods : The study included baseline data collected in 1981 through 1983 on 10,955 persons age 40 to 79 years and baseline data collected in 1991 through 1994 on 7212 persons age 40 to 79 years . We used hospital diagnosis data from the Danish National Hospital Discharge Register to determine the rate of first hospital admission for atrial fibrillation during 7 years following each of the 2 baseline data collecting periods . Changes in admission rates were analyzed using Cox proportional hazard models . Results : During the 2 7-year periods , 379 subjects were admitted with a hospital diagnosis of atrial fibrillation . The rate of hospital admissions for atrial fibrillation increased among both men and women from the first to the second period ( relative risk = 1.6 ; 95 % confidence interval = 1.3–1.9 [ adjusted for age , sex , prior myocardial infa rct ion , arterial hypertension , diabetes mellitus , electrocardiographic left ventricular hypertrophy , decreased lung function , smoking , height , and weight ] ) . Conclusion : During the latest 10 to 20 years , there has been a 60 % increase in hospital admissions for atrial fibrillation independent of changes in known risk factors . This increase could result from changes in admission threshold or coding practice s , or it could reflect a genuine increase in the population incidence of atrial fibrillation",
"BACKGROUND AND PURPOSE Stroke occurring with atrial fibrillation ( AF ) is more likely to be fatal or more severe than non-AF stroke based on clinical series , but data from prospect i ve epidemiological studies are sparse and inconsistent . METHODS Over 40-year follow-up of the original 5070 Framingham cohort , 501 initial ischemic strokes , including 103 with AF , were analyzed . Stroke severity was rated as none , mild , moderate , severe , or fatal . Since 1981 , functional status indicated by the Barthel index has been evaluated acutely and at 3 , 6 , and 12 months . Severity and functional status of AF strokes were compared with non-AF strokes using chi 2 test and Student 's t test . Thirty-day mortality was assessed by logistic regression analyses . RESULTS AF was associated with increased stroke severity ( P = .048 ) . Thirty-day mortality was greater in AF strokes than in non-AF strokes ( 25 % versus 14 % ) . The multivariate-adjusted odds ratio for 30-day mortality for AF subjects was 1.84 ( 95 % confidence interval , 1.04 to 3.27 ) . Since 1981 , follow-up was available for 150 initial ischemic strokes , including 30 with AF . Compared with the non-AF group , the AF group had poorer survival and more recurrences during 1 year of follow-up . The AF subjects had lower mean Barthel index scores acutely ( 29.6 versus 58.6 , P fatal as non-AF stroke . Recurrence was more frequent , and functional deficits were more likely to be severe among survivors . Since stroke is usually the initial manifestation of embolism in AF , prevention is critical to reducing disability and mortality",
"Atrial fibrillation ( AF ) is a common arrhythmia in elderly persons and a common cause of embolic stroke . Most studies of the prevalence and correlates of AF have used selected , hospital-based population s. The Cardiovascular Health Study is a population -based , longitudinal study of risk factors for coronary artery disease and stroke in 5,201 men and women aged > or = 65 years . AF was diagnosed in 4.8 % of women and in 6.2 % of men at the baseline examination , and prevalence was strongly associated with advanced age in women . Prevalence of AF was 9.1 % in men and women with clinical cardiovascular disease , 4.6 % in patients with evidence of sub clinical but no clinical cardiovascular disease , and only 1.6 % in subjects with neither clinical nor sub clinical cardiovascular disease . A history of congestive heart failure , valvular heart disease and stroke , echocardiographic evidence of enlarged left atrial dimension , abnormal mitral or aortic valve function , treated systemic hypertension , and advanced age were independently associated with the prevalence of AF . The low prevalence of AF in the absence of clinical and sub clinical cardiovascular disease calls into question the existence and clinical usefulness of the concept of so-called \" lone atrial fibrillation \" in the elderly",
"Background Early detection of atrial fibrillation ( AF ) in older people is important because AF is often asymptomatic and its first manifestation may be a disabling stroke . The objective of the LietoAF Study is to assess the motivation and capability of older people to learn pulse palpation and continue regular pulse measurements , and whether this self- assessment is helpful in the detection of new AF . Design and method The LietoAF Study is an intervention study . A total of 205 people aged ≥75 years were r and omly selected to participate in the programme where a trained nurse gave individual education on pulse palpation . At 1 month , the eligible participants came to the first follow-up visit to assess the success of pulse self-monitoring . Results A total of 139 participants ( 68 % ) learned pulse palpation and performed regular measurements during the early follow-up period . The significant independent predictors for learning and motivation were high Mini-Mental State Examination score ( > 24 ) ( OR 7.5 , 95 % CI 1.5–37.3 , p = 0.014 ) , computer use at home ( OR 4.7 , 95 % CI 1.9–11.5 , p = 0.001 ) , independence at daily activities ( OR 4.2 , 95 % CI 1.4–13.6 , p = 0.013 ) and low heart rate ( OR 1.04 , 95 % CI 1.0–1.08 , p = 0.037 ) . Education did not cause extra visits to local healthcare centres and did not affect quality of life . Four participants observed a new asymptomatic AF during the 1-month follow-up . Conclusion Active older people are motivated and seem to learn pulse palpation . Our early experience suggests that simple nurse-based education is effective and useful in the early detection of asymptomatic AF",
"Estimates of the risk of stroke for men with non-rheumatic atrial fibrillation were obtained from two large cohort studies --the Whitehall Study of London Civil Servants and the British Regional Heart Study . The first cohort provided an estimated relative risk of stroke of 6.9 compared with controls . This increased risk confirms that of the other prospect i ve estimate , 5.6 , found in the Framingham study . In the second cohort only one of the men at risk had a stroke , and the risk estimate did not differ significantly from unity . The absolute rates of stroke in both cohorts were lower than those reported in the Framingham study , implying a lesser potential benefit from preventive measures . These lower rates should be considered in the planning of trials . The risk of stroke was significantly associated with raised systolic or diastolic blood pressure but not with age or coronary heart disease",
"Objective . To evaluate whether routinely performed ECGs in older people from the general population have added value for cardiovascular risk management beyond the information that is already available from their medical records . Design . Observational , prospect i ve cohort study . Setting . General population . Subjects . A total of 566 participants aged 85 years ( 377 women , 189 men ) . Methods . Lifelong history of cardiovascular disease was assessed through medical records obtained from general practitioners . Baseline ECGs were evaluated for prior myocardial infa rct ion and atrial fibrillation . During a 5-year follow-up period , complete cardiovascular mortality and morbidity data were gathered . Results . During 5 years of follow-up , 262/566 ( 46 % ) participants died , of whom 102/262 ( 39 % ) died from cardiovascular disease . Participants with a history of cardiovascular disease at age 85 years ( 284/566 , 50 % ) had an increased cardiovascular mortality ( HR 2.7 , 95 % CI 1.8–4.1 ) and morbidity ( HR myocardial infa rct ion 2.1 , 95 % CI 1.3–3.6 ; HR stroke 2.7 , 95 % CI 1.6–4.9 ) compared with those without such a history . Participants with major ECG abnormalities ( 102/566 , 18 % ) had an increased cardiovascular mortality ( HR 1.8 , 95 % CI 1.1–2.8 ) , but no increase of cardiovascular morbidity compared with those without major ECG abnormalities . In both participants with and without a history of cardiovascular disease , the presence of major ECG abnormalities was not associated with increased cardiovascular mortality or morbidity . Conclusions . In older people from the general population , a history of cardiovascular disease is a strong predictor of cardiovascular mortality and morbidity . Although abnormal findings on routine ECGs predict cardiovascular mortality , they do not provide additional prognostic information beyond the information available from medical records . Therefore , when accurate medical records are available , programmatic ECG recording is not effective in older people",
"OBJECTIVES To determine the most cost-effective method of screening for atrial fibrillation ( AF ) in the population aged 65 years and over , as well as its prevalence and incidence in this age group . Also to evaluate the relative cost-effectiveness of different methods of recording and interpreting the electrocardiogram ( ECG ) within a screening programme . DESIGN Multicentred r and omised controlled trial . Purpose fully selected general practice s were r and omly allocated to 25 intervention practice s and 25 control practice s. SETTING Fifty primary care centres across the West Midl and s , UK . PARTICIPANTS Patients aged 65 years and over . INTERVENTIONS GPs and practice nurses in the intervention practice s received education on the importance of AF detection and ECG interpretation . Patients in the intervention practice s were r and omly allocated to systematic ( n = 5000 ) or opportunistic screening ( n = 5000 ) . Prospect i ve identification of pre-existing risk factors for AF within the screened population enabled comparison between targeted screening of people at higher risk of AF and total population screening . MAIN OUTCOME MEASURES AF detection rates in systematic ally screened and opportunistically screened population s in the intervention practice s were compared with AF detection rate in 5000 patients in the control practice s. The screening period was 12 months . RESULTS Baseline prevalence of AF was 7.2 % , with a higher prevalence in males ( 7.8 % ) and patients aged 75 years and over ( 10.3 % ) . The control population demonstrated higher baseline prevalence ( 7.9 % ) than either the systematic ( 6.9 % ) or opportunistic ( 6.9 % ) intervention population . In the control population 47 new cases were detected ( incidence 1.04 % per year ) . In the opportunistic arm 243 patients without a baseline diagnosis of AF were found to have an irregular pulse , with 177 having an ECG , yielding 31 new cases ( incidence 0.69 % per year ) . A further 44 cases were detected outside the screening programme ( overall incidence 1.64 % per year ) . In the systematic arm 2357 patients had an ECG yielding 52 new cases ( incidence 1.1 % per year ) . Of these , 31 were detected by targeted screening and a further 21 by total population screening . A further 22 cases were detected outside the screening programme ( overall incidence 1.62 % per year ) . In terms of ECG interpretation , computerised decision support software ( CDSS ) gave a sensitivity of 87.3 % , a specificity of 99.1 % and a positive predictive value ( PPV ) of 89.5 % compared with the gold st and ard ( cardiologist reporting ) . GPs and practice nurses performed less well . The only difference in performance between intervention population s and controls was that practice nurses from the control arm performed less well than with intervention practice nurses on interpretation of limb-lead ( PPV 38.8 % versus 20.8 % ) and single-lead ( PPV 37.7 % versus 24.0 % ) ECGs . The within-trial economic evaluation results showed the lowest incremental cost to be for the opportunistic arm , with an incremental cost-effectiveness ratio of 337 pounds Sterling for each additional case detected compared to the control arm . Opportunistic screening dominated both more intensive screening strategies . Model-based analyses showed small differences in cost and quality -adjusted life-years for different methods and intensities of screening , but annual opportunistic screening result ed in the lowest number of ischaemic strokes and greatest proportion of cases of AF diagnosed . Probabilistic sensitivity results indicated that there was a probability of approximately 60 % that screening from the age of 65 years was cost-effective in both men and women . CONCLUSIONS The results of the study indicated that in terms of a screening programme for atrial fibrillation in patients 65 and over , the only strategy that improved on routine practice was opportunistic screening , model-based analyses indicated that there was a probability of approximately 60 % of annual opportunistic screening being cost effective . It is suggested that the following topics are worthy of further investigation : the effect of the implementation of a screening programme for AF on the uptake and maintenance of anticoagulation in patients aged 65 years and over ; an evaluation of the role of CDSS in the diagnosis of cardiac arrythmias ; the best method for routinely detecting paroxysmal AF ; ways of improving healthcare professionals ' performance in ECG interpretation ; development of a robust economic model to incorporate data on new therapeutic agents for use as thromboprophylactic agents for patients with AF , and an evaluation of the relative risk of stroke for patients with incident as opposed to prevalent AF",
"Objective : To evaluate clinical and cost effectiveness of implementing evidence -based guidelines for the prevention of stroke . Design : Cluster-r and omised trial Setting : Three primary care organisations in the North of Engl and covering a population of 400 000 . Participants : Seventy six primary care teams in four clusters : North , South & West , City I and City II . Intervention : Guidelines for the management of patients with atrial fibrillation and transient ischaemic attack ( TIA ) were developed and implemented using a multifaceted approach including evidence -based recommendations , audit and feedback , interactive educational sessions , patient prompts and outreach visits . Outcomes : Identification and appropriate treatment of patients with atrial fibrillation or TIA , and cost effectiveness . Results : Implementation led to 36 % increase ( 95 % CI 4 % to 78 % ) in diagnosis of atrial fibrillation , and improved treatment of TIA ( odds ratio of complying with guidelines 1.8 ; 95 % CI 1.1 to 2.8 ) . Combined analysis of atrial fibrillation and TIA estimates that compliance was significantly greater ( OR 1.46 95 % CI 1.10 to 1.94 ) in the condition for which practice s had received the implementation programme . The development and implementation of guidelines cost less than £ 1500 per practice . The estimated costs per quality -adjusted life year gained by patients with atrial fibrillation or TIA were both less than £ 2000 , very much less than the usual criterion for cost effectiveness . Conclusions : Implementation of evidence -based guidelines improved the quality of primary care for atrial fibrillation and TIA . The intervention was feasible and very cost effective . Key components of the model include context ual analysis , strong professional support , clear recommendations based on robust evidence , simplicity of adoption , good communication and use of established networks and opinion leaders",
"AIMS We aim ed to investigate the prevalence and incidence of atrial fibrillation ( AF ) in a large European population -based study . METHODS AND RESULTS The study is part of the Rotterdam study , a population -based prospect i ve cohort study among subjects aged 55 years and above . The prevalence at baseline was assessed in 6808 participants . Incidence of AF was investigated during a mean follow-up period of 6.9 years in 6432 persons . We identified 376 prevalent and 437 incident cases . Overall prevalence was 5.5 % , rising from 0.7 % in the age group 55 - 59 years to 17.8 % in those aged 85 years and above . The overall incidence rate was 9.9/1000 person-years . The incidence rate in the age group 55 - 59 years was 1.1/1000 person-years , rose to 20.7/1000 person-years in the age group 80 - 84 years and stabilized in those aged 85 years and above . Prevalence and incidence were higher in men than in women . The lifetime risk to develop AF at the age of 55 years was 23.8 % in men and 22.2 % in women . CONCLUSION In this prospect i ve study in a European population , the prevalence and incidence of AF increased with age and were higher in men than in women . The high lifetime risk to develop AF was similar to North American epidemiological data",
"BACKGROUND Because palpitations and light headedness often occur paroxysmally these complaints are difficult to diagnose . The hazards for a GP are too many diagnostic interventions for worried well and too few diagnostics for potentially life threatening complaints . OBJECTIVES Patient-activated memo event recorders have proved to be successful in diagnosing episodes of cardiac arrythmias in secondary care . We tested the diagnostic yield of these devices in general practice . METHODS A r and omized clinical trial in general practice . Consecutive patients with complaints of palpitations or light-headedness were r and omized to either usual care or usual care plus event-recorder . The main outcome was the difference in explained episodes . Secondary outcomes were the differences in the number and character of cardiac diagnoses and the feasibility of the event-recorder . RESULTS There were fewer patients without a diagnosis in the intervention group ( 17 % vs 38 % ; RR = 0.5 , 95 % CI 0.3 to 0.7 ) and more patients with a cardiac diagnosis ( 67 % vs. 27 % : RR 2.5 , CI 1.8 to 3,5 ) . More relevant cardiac arrhythmias were detected ( 22 % vs 7 % ) with event recording than with usual care ( RR 3.2 , 95 % CI 1.5 to 6.8 ) . CONCLUSION Patient-activated loop recorders are feasible and effective diagnostic tools in patients with palpitations or light-headedness in primary care . More research into patient characteristics and selection criteria is needed to fine-tune the use of these devices in primary care",
"BACKGROUND There are two approaches to the treatment of atrial fibrillation : one is cardioversion and treatment with antiarrhythmic drugs to maintain sinus rhythm , and the other is the use of rate-controlling drugs , allowing atrial fibrillation to persist . In both approaches , the use of anticoagulant drugs is recommended . METHODS We conducted a r and omized , multicenter comparison of these two treatment strategies in patients with atrial fibrillation and a high risk of stroke or death . The primary end point was overall mortality . RESULTS A total of 4060 patients ( mean [ + /-SD ] age , 69.7+/-9.0 years ) were enrolled in the study ; 70.8 percent had a history of hypertension , and 38.2 percent had coronary artery disease . Of the 3311 patients with echocardiograms , the left atrium was enlarged in 64.7 percent and left ventricular function was depressed in 26.0 percent . There were 356 deaths among the patients assigned to rhythm-control therapy and 310 deaths among those assigned to rate-control therapy ( mortality at five years , 23.8 percent and 21.3 percent , respectively ; hazard ratio , 1.15 [ 95 percent confidence interval , 0.99 to 1.34 ] ; P=0.08 ) . More patients in the rhythm-control group than in the rate-control group were hospitalized , and there were more adverse drug effects in the rhythm-control group as well . In both groups , the majority of strokes occurred after warfarin had been stopped or when the international normalized ratio was subtherapeutic . CONCLUSIONS Management of atrial fibrillation with the rhythm-control strategy offers no survival advantage over the rate-control strategy , and there are potential advantages , such as a lower risk of adverse drug effects , with the rate-control strategy . Anticoagulation should be continued in this group of high-risk patients",
"BACKGROUND Atrial fibrillation ( AF ) is an important public health problem . This arrhythmia is common and associated with a high risk of stroke . Further , appropriate interventions in AF can reduce the risk of stroke by approximately 68 % . Population studies show that a large group of patients have intermittent or chronic AF that remains unrecognized . If a simple screening test for this arrhythmia could be developed and vali date d , application of the technique across population s might identify AF patients for early treatment , potentially reducing the incidence of stroke . In this study , we sought to determine whether individuals taken from the general community could be taught to find and classify the pulse of another as very irregular , implying AF , or regular , implying normal sinus rhythm ( NSR ) . The aim was to establish that pulse examination for potential AF could be performed by individuals with sufficient sensitivity and specificity to be effectively used as a screening procedure for this medically important arrhythmia . METHODS We enrolled 178 subjects selected from the general community from four centers . Subjects received st and ardized education on the medical importance of AF and its signature , a very irregular pulse . A technique for palpating and characterizing the rhythm of the radial pulse was also taught . Without further coaching , subjects were then asked to find their pulse and then to find and classify the pulse of two models r and omly presented who may or may not have had AF . RESULTS Of the 178 subjects tested , 92 % were able to find their own pulse ; 17 ( 9.6 % ) were unable to find the pulse of one or both patient models and were , therefore , excluded from the study . Of the remaining 161 subjects , 76 % ( 122 of 161 ) correctly identified the pulse in an AF model , and 86 % ( 139 of 161 ) correctly identified the pulse in an NSR model . Results did not statistically differ as a function of age , educational status , or location . DISCUSSION This multicenter trial established that given minimal st and ardized instructions , subjects from the general community can reliably and consistently find both their pulse as well as the pulse of another and to differentiate a regular pulse from a very irregular pulse . If similar educational programs were widely applied across large population s , periodic screening for AF might lead to earlier diagnosis and appropriate treatment for patients who have this major risk factor for stroke . These screening programs should be focused on the population over the age of 55 where the risk of stroke in AF increases with each decade",
"BACKGROUND Atrial fibrillation is a common and treatable cause of stroke that often remains unrecognised . Screening has been suggested but there is very little evidence concerning the uptake of screening in the elderly population at risk , nor of the optimal method of screening in a general practice setting AIM To compare the uptake and effectiveness of two methods of screening for atrial fibrillation in general practice -- systematic nurse-led screening and prompted opportunistic case finding . DESIGN OF STUDY R and omised controlled trial . SETTING Patients aged 65 to 100 years ( n = 3,001 ) from four general practice s within the MRC general practice framework . METHOD Each of the four study practice s were selected from one quartile , after ranking all framework practice s according to the small area st and ardised mortality ratio of the geographical area served . Patients were r and omised either to nurse-led screening or to prompted opportunistic casefinding . The proportion of patients assessed and the proportion found to have atrial fibrillation were compared . The sensitivity and specificity of clinical assessment of pulse are also reported . RESULTS Substantially more patients had their pulse assessed through systematic screening by invitation ( 1,099/1,499 [ 73 % ] ) than through opportunistic case finding ( 439/1,502 [ 29 % ] , difference = 44 % , 95 % confidence interval [ CI ] = 41 % to 47 % ) . Atrial fibrillation was detected in 67 ( 4.5 % ) and 19 ( 1.3 % ) patients respectively ( difference = 3.2 % , 95 % CI= 2.0 to 4.4 ) . Invitation to nurse-led screening achieved significantly higher assessment rates than case finding in all practice s ; however , the proportion of patients assessed in the case-finding arm varied markedly between practice s ( range = 8 % to 52 % ) . The number needed to screen to identify one additional patient with atrial fibrillation was 31 ( 95 % CI = 23 to 50 ) . The proportion of screened patients with atrial fibrillation receiving anticoagulation treatment was 25 % , although in the majority ( 53/65 [ 82 % ] ) atrial fibrillation had been previously recorded somewhere on their medical record . If the nurse used any irregularity of the pulse as the screening criterion , the sensitivity of screening was 91 % and the specificity was 74 % ; sensitivity fell to 54 % but specificity increased to 98 % if the criterion used was continuous irregularity . CONCLUSIONS Nurse-led screening for atrial fibrillation in UK general practice is both feasible and effective and will identify a substantial number of patients who could benefit from antithrombotic therapy . Although the majority of patients detected at first screening could be identified by careful scrutiny of medical records , review of record summaries was insufficient in the practice s involved in this study and screening may be a more cost-effective option",
"Objectives Screening for colorectal cancer by biennial testing for faecal occult blood is being introduced in the UK from 2007 . We examine the likely impact of the programme , in terms of reduced mortality , lives saved and changes in incidence , over the next 20 years . Setting Projections of incidence and mortality of colorectal cancer in Engl and , and the policy that has been adopted for screening in Engl and ( biennial at ages 60–69 from 2007 , then 60–74 in 2010 ) . Methods The results are based on the output of a simulation model that has been used to examine cost-effectiveness of screening policy options , with two scenarios regarding compliance with screening ; both assume that 20 % of the population will never attend for screening , but attendance of those who do is modelled either as a r and om 60 % or 80 % , at each screening round . Results The decrease in mortality rates expected 20 years after introducing screening is 13–17 % in men and 12–15 % in women ( depending on the attendance levels ) . The model predicts an initial rise in incidence , followed ( after six to seven years ) by a fall , so that there is little net change in the number of cases detected over a 20-year period . Conclusion Percentage changes in mortality seem modest , but the projected saving in terms of numbers of lives is not negligible – 1800–2400 per year by 2025 in Engl and ( equivalent numbers are 2200–2700 in all over the UK ) . Newer screening modalities may improve on these projected results"
] | 411635ee-06ff-11f0-808a-c43d1ab1c353 |
STUDY DESIGN The Oswestry Disability Index ( ODI ) has become one of the principal condition-specific outcome measures used in the management of spinal disorders . This review is based on publications using the ODI identified from the authors ' personal data bases , the Science Citation Index , and h and search es of Spine and current textbooks of spinal disorders . OBJECTIVES To review the versions of this instrument , document methods by which it has been vali date d , collate data from scores found in normal and back pain population s , provide curves for power calculations in studies using the ODI , and maintain the ODI as a gold st and ard outcome measure . SUMMARY OF BACKGROUND DATA It has now been 20 years since its original publication . More than 200 citations exist in the Science Citation Index . The authors have a large correspondence file relating to the ODI , that is cited in most of the large textbooks related to spinal disorders . METHODS All the published versions of the question naire were identified . A systematic review of this literature was made . The various reports of validation were collated and related to a version . RESULTS Four versions of the ODI are available in English and nine in other language s. Some published versions contain misprints , and many omit the scoring system . At least 114 studies contain usable data . These data provide both validation and st and ards for other users and indicate the power of the instrument for detecting change in sample population s. CONCLUSIONS The ODI remains a valid and vigorous measure and has been a worthwhile outcome measure . The process of using the ODI is review ed and should be the subject of further research . The receiver operating characteristics should be explored in a population with higher self-report disabilities . The behavior of the instrument is incompletely understood , particularly in sensitivity to real change | [
"Abstract The inability to predict outcome in patients with low back/neck pain leads to inappropriate or unnecessary treatment . The aims of the study were to identify prognostic factors for disability at 1‐year follow‐up in patients with back pain visiting primary care , and to compare the effect of these in two treatment strategies – chiropractic and physiotherapy . Data were taken from a r and omised trial on patients with back/neck pain visiting the general practitioner , in which patients were allocated to chiropractic and physiotherapy as primary management . Three hundred and twenty‐three patients , aged 18–60 years , who had no contraindications to manipulation and who had not been treated within the previous month were included in the study . Multiple regression analysis was used to identify prognostic factors . Dependent variables were mean Oswestry score and mean change in Oswestry score at 12‐month follow‐up . The multiple regression analysis revealed five significant ( P ; duration of current episode , Oswestry score at entry , expectations of treatment , number of localisations , and well‐being . Besides , the regression coefficients for the significant factors were compared between the two treatment strategies . No significant difference in effect or regression coefficients for the prognostic factors were seen between the two treatment strategies . Twelve per cent of the patients had poor prognostic factors ( duration ≥1 month , more than one localisation , low expectations of treatment and low well‐being ) at entry . These patients had a mean Oswestry score above 20 % at 1‐year follow‐up . Clinical decision models for the management of patients with back pain visiting primary care that consider prognostic factors need to be implemented and prospect ively evaluated",
"In clinical measurement comparison of a new measurement technique with an established one is often needed to see whether they agree sufficiently for the new to replace the old . Such investigations are often analysed inappropriately , notably by using correlation coefficients . The use of correlation is misleading . An alternative approach , based on graphical techniques and simple calculations , is described , together with the relation between this analysis and the assessment of repeatability",
"In a study that indicates more definitive investigation is needed , 118 patients with chronic back problems seeking treatment for acute attacks of pain were included in a 4-week r and omised double-blinded study on the safety and effectiveness of an extract of Harpagophytum procumbens . Both , the treatment and the placebo were administered in the form of two tablets taken three times per day ; the treatment group had a daily consumption equal to 6,000 mg of crude preparation ( 50 mg harpagoside , the putative active ingredient ) . The treatment and placebo groups were well matched in physical characteristics ; in the severity , duration , nature and accompaniments of their pain ; and in laboratory indices of organ system function . 109 patients completed the study . The study was originally design ed to measure Harpagophytum 's effectiveness by measuring the use of supplementary pain-killer Tramadol over its final 3 weeks . However , this did not differ between the Harpagophytum and placebo groups nor was the consumption closely related to the amount of pain . Further analysis , though , revealed that 9 out of 51 patients who received the extract were pain free at the end of treatment compared to only 1 out of 54 patients who received placebo . A modification of the Arhus index was used as an additional measure , covering the more global impact . The percentage change was greater in those patients who received Harpagophytum extract than in those who received placebo , but inferential testing ( Mann Whitney ) allowed only 94 % degree of confidence that this had not arisen by chance . The Arhus index reduction was based on improvement in pain . This indication of effectiveness , and the absence of demonstrable adverse effects show that more definite clinical studies of Harpagophytum extract will be worthwhile",
"Study Design . A prospect i ve cohort study of patients with subacute occupational back pain . Objectives . To study the relation between a marketed opto‐electric device measuring trunk kinematics , a widely used specific functional capacity question naire , and work status in back pain patients , and to assess the responsiveness to change in work status of the opto‐electric device and the question naire . Summary of Background Data . Several instruments have been developed to evaluate the functional capacities of patients with back pain , but the relation between these instruments and work status has rarely been studied . Methods . The relation between the opto‐electric device , the question naire , and work status in patients with back pain was evaluated . The study population was a prospect i ve cohort of patients with subacute back pain who were absent from regular work for more than 4 weeks . All data were compiled blindly on the same day , at study entry ( 4 weeks after work accident ) , and at 12 , 24 , and 52 weeks after the work accident . The validity of the question naire and opto‐electric device scores was assessed with partial correlation analyses , st and ardized response mean , logistic regression analyses , and receiver operating characteristics curves . Results . The correlation between the question naire and opto‐electric device scores was low . The question naire scores were significantly related to work status , but the opto‐electric device scores were not . The question naire was responsive to change in work status , whereas the opto‐electric device was not . Conclusions . The opto‐electric device scores were not related to either functional capacity scores ( question naire ) or work status in patients with low back pain , and the opto‐electric device was not responsive to change in work status . Conversely , the question naire was related to work status and was responsive to change in work status",
"A BSTRACT Background Although epidural corticosteroid injections are commonly used for sciatica , their efficacy has not been established . Methods In a r and omized , double-blind trial , we administered up to three epidural injections of methylprednisolone acetate ( 80 mg in 8 ml of isotonic saline ) or isotonic saline ( 1 ml ) to 158 patients with sciatica due to a herniated nucleus pulposus . All patients had Oswestry disability scores higher than 20 ( on a scale of 1 to 100 , with scores of 20 or less indicating minimal disability , and higher scores greater disability ) . Results At three weeks , the Oswestry score had improved by a mean of 8.0 in the methylprednisolone group and 5.5 in the placebo group ( 95 percent confidence interval for the difference , 7.1 to 2.2 ) . Differences in improvements between the groups were not significant , except for improvements in the finger-to-floor distance ( P 0.006 ) and sensory deficits ( P 0.03 ) , which were greater in the methylprednisolone group . After six weeks , the only significant difference was the improvement in leg pain , which was greater in the methylprednisolone group ( P 0.03 ) . After three months , there were no significant differences between the groups . The Oswestry score had improved by a mean of 17.3 in the methylprednisolone group and 15.4 in the placebo group ( 95 percent confidence interval for the difference , 9.3 to 5.4 ) . At 12 months , the cumulative probability of back surgery was 25.8 percent in the methylprednisolone group and 24.8 percent in the placebo group ( P 0.90 ) . Conclusions Although epidural injections of methylprednisolone may afford short-term improvement in leg pain and sensory deficits in patients with sciatica due to a herniated nucleus pulposus , this treatment offers no significant functional benefit , nor does it reduce the need for surgery . ( N Engl J Med 1997 ; 336:1634 - 40 .",
"BACKGROUND AND PURPOSE The Rol and -Morris Question naire ( RMQ ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale . The RMQ has been shown to yield reliable measurements , which are valid for inferring the level of disability , and to be sensitive to change over time for groups of patients with low back pain . Little is known about the usefulness of this instrument in aiding decision making regarding individual patients . The purpose of this study was to determine the minimum level of detectable change when the RMQ is applied to individual patients . SUBJECTS The study sample consisted of 60 out patients with low back pain . METHODS The RMQ was administered at the subjects ' initial visit and again 4 to 6 weeks later . Conditional st and ard errors of measurement ( CSEMs ) were computed for initial and follow-up RMQ scores , and these values were used to estimate the minimum level of detectable change . Results . Minimum levels of detectable change at the 90 % confidence level varied from 4 to 5 RMQ points . CONCLUSION AND DISCUSSION The magnitude of CSEMs is sufficiently small to detect change in patients with initial scores in the central portion of the scale ( 4 - 20 RMQ points ) ; however , the magnitude is too large to detect improvement in patients with scores of less than 4 and deterioration in patients who have scores greater than 20",
"McKenzie 's methods for evaluating and treating low back pain are used often but studied little . When using the McKenzie system , it is important to observe signs of symptom movement to a central location ( central ization ) . This study investigated the relationships between central ization of low back pain and /or radiculopathy and the subjects ' rating of functional outcome . Thirty-six subjects with low back pain volunteered to participate and were evaluated and treated by six research ers . Subjects were tested initially and again 14 days after initiation of treatment using the Oswestry Low Back Pain Disability Question naire and the Performance Assessment and Capacity Testing Spinal Function Sort ( SFS ) . Symptoms were monitored for the occurrence of \" complete central ization . \" Of the 36 subjects , 25 showed complete central ization within 14 days . The SFS score changes were significantly higher for subjects who completely central ized ( p = 0.015 ) . The results supported the hypothesis that subjects who central ize will have improved functional outcome and , thus , quality of life . However , shorter time to occurrence of complete central ization does not necessarily correlate with improved outcome",
"Study Design . Population ‐based r and omized clinical trial . Objectives . To develop and test a model of management of subacute back pain , to prevent prolonged disability . Summary of Background Data . The present management of back pain seems inadequate , and development of innovative models has been urged . Methods . A model for the treatment of subacute work‐related back pain has been developed and evaluated in a population ‐based r and omized clinical trial . Workers ( n = 130 ) from eligible workplaces in the Sherbrooke area ( N = 31 ) , who had been absent from work for more than 4 weeks for back pain , were r and omized , based on their workplace , in one of four treatment groups : usual care , clinical intervention , occupational intervention , and full intervention ( a combination of the last two ) . The duration of absence from regular work and from any work was evaluated using survival analysis . Functional status and pain were compared at study entry and after 1 year of follow‐up . Results . The full intervention group returned to regular work 2.41 times faster than the usual care intervention group ( 95 % confidence interval 1.19‐4.89 ; P = 0.01 ) . The specific effect of the occupational intervention accounted for the most important part of this result , with a rate ratio of return to regular work of 1.91 ( 95 % confidence interval = 1.18‐3.10 ; P demonstrated either a statistically significant reduction or a trend toward reduction in the three intervention groups , compared with the trend in the usual care intervention group . Conclusions . Close association of occupational intervention with clinical care is of primary importance in impeding progression toward chronicity of low back pain",
"OBJECTIVE To evaluate a progressive fitness programme for patients with chronic low back pain . DESIGN Single blind r and omised controlled trial . Assessment s were carried out before and after treatment by an observer blinded to the study and included a battery of vali date d measures . All patients were followed up by postal question naire six months after treatment . SETTING Physiotherapy department of orthopaedic hospital . SUBJECTS 81 patients with chronic low back pain referred from orthopaedic consultants for physiotherapy . The patients were r and omly allocated to a fitness programme or control group . INTERVENTION Both groups were taught specific exercises to carry out at home and referred to a back-school for education in back care . Patients allocated to the fitness class attended eight exercise classes over four weeks in addition to the home programme and backschool . RESULTS Significant differences between the groups were shown in the changes before and after treatment in scores on the Oswestry low back pain disability index ( P pain reports ( sensory P self efficacy reports ( P walking distance ( P general health question naire or question naire on pain locus of control . A benefit of about 6 percentage points on the disability index was maintained by patients in the fitness group at six months . CONCLUSION There is a role for supervised fitness programmes in the management of moderately disabled patients with chronic low back pain . Further clinical trials , however , need to be established in other centres to confirm these findings",
"Reprinted with permission from the British Medical Journal 300:1431 - 1437.1990 . Objective - To compare chiropractic and hospital outpatient treatment for managing low back pain of mechanical origin . Design - R and omized controlled trial . Allocation to chiropractic or hospital management by minimization to establish groups for analysis of results according to initial referral clinic , length of current episode , history , and severity of back pain . Patients were followed up for up to two years . Setting - Chiropractic and hospital outpatient clinics in 11 centers . Patients - 741 patients aged 18 - 65 who had no contraindications to manipulation and who had not been treated within the past month . Interventions - Treatment at the discretion of the chiropractors , who used chiropractic manipulation in most patients , or of the hospital staff , who most commonly used Maitl and mobilization or manipulation , or both . Main outcome measures - Changes in the score on the Oswestry pain disability question naire and in the results of tests of straight leg raising and lumbar flexion . Results - Chiropractic treatment was more effective than hospital outpatient management , mainly for patients with chronic or severe back pain . A benefit of about 7 percent points on the Oswestry scale was seen at two years . The benefit of chiropractic treatment became more evident throughout the follow-up period . Secondary outcome measures also showed that chiropractic was more beneficial . Conclusions - For patients with low back pain in whom manipulation is not contraindicated , chiropractic almost certainly confers worthwhile , long-term benefit in comparison with hospital outpatient management . The benefit is seen mainly in those with chronic or severe pain . Introducing chiropractic into NHS practice should be considered . J Orthop Sports Phys Ther 1991;13(6):278 - 287",
"Study Design The measurement properties and validity of a newly developed patient question naire for the assessment of patients with lumbar spinal stenosis was tested in an ongoing prospect i ve multicenter observational study of patients undergoing decompressive surgery in three teaching hospitals . Objective The goal of the study was to develop a short , self‐administered question naire on symptom severity , physical functional status , and patient satisfaction . Summary of Background Data The measure is intended to complement existing generic measures of spinal‐related disability and health status . The question naire includes three scales with seven questions on symptom severity , five on physical function , and six on satisfaction . Methods The internal consistency of the scales was assessed with Cronbach 's coefficient alpha on crosssectional data from 193 patients before surgery . The test‐retest reliability was assessed on data from a r and om sample of 23 patients using Spearman 's rank correlation coefficient . The responsiveness was assessed on 130 patients with 6‐month follow‐up data using the st and ardized response mean . Results The test‐retest reliability of the scales ranged from 0.82 to 0.96 , the internal consistency from 0.64 to 0.92 , and the responsiveness from 0.96 to 1.07 . The direction , statistical significance , and strength of hypothesized relationships with external criteria were as expected . Conclusions This short self‐administered spinal stenosis measure is reproducible , internally consistent , valid , and highly responsive . It can be used to complement generic instruments in outcome assessment of patients with lumbar spinal stenosis",
"External transpedicular fixation was applied to the lower lumbar spine in a prospect i ve study on 42 patients with chronic low back pain combined with suspected instability of the lumbar segments ; the diagnosis was failed disk surgery , spondylolisthesis , and degenerative disk disease . The aim was to realign the involved segments , to restore disk height , and to record changes in pain and performance during the external fixation test . Pain was recorded on a visual analog scale , and performance was assessed using the Oswestry disability score . As independent observer assessed the test and treatment results . Twenty-nine patients experienced relief of pain and performed better in the fixator ; they were subjected to anterior interbody fusion , the external frame being kept as a stabilizing device for an additional four months . Twenty-two patients have had follow-up evaluations for two years . One and two years after successful lumbar fusion , significantly ( p pain and performance scores were recorded ; the results of lumbar fusion corresponded to the preoperative fixation test . A temporary external fixation test may be a useful procedure in patients considered for subsequent spondylodesis",
"Study Design . Open , prospect i ve trial with patients participating in an active back restoration program . Objectives . To compare the concentrations of biochemical indicators of Type I and III collagen synthesis and Type I collagen degradation in the serum of patients with chronic low back pain and healthy control subjects and to evaluate the effect of active back rehabilitation based on vigorous exercise on collagen metabolism . Summary of Background Data . The aim of active back rehabilitation is to restore the physical function of low back pain patients falling into the so-called \" deconditioning syndrome . \" The changes in functional muscle strength measurements during the restoration rehabilitation program always depend on motivation , learning phenomena , and fear of pain and injury , so that even more objective ways of showing changes in physical activity are needed . Methods . Specific radioimmunoassays for the amino-terminal ( PINP ) and carboxy-terminal ( PICP ) propeptides of Type I procollagen , the amino-terminal propeptide of Type III procollagen ( PIIINP ) , and the cross-linked carboxy-terminal telopeptide of Type I collagen ( ICTP ) were used for serum sample s obtained from 41 patients before , during , and after an active back restoration program and from 16 age- and sex-matched healthy control subjects . Results . The circulating concentrations of PINP and PICP were initially lower in the patients ( [ mean ± SD ] 35.3 ± 12.5 μg/L and 119.0 ± 32.6 μg/L , respectively ) than in the control subjects ( 47.9 ± 18.0 μg/L and 136.7 ± 47.7 μg/L , respectively ; P active back rehabilitation program , both PINP and PICP increased in the patients ( P circulating PICP concentration increasing earlier than that of PINP . In the intervention group , the PIIINP concentration also increased ( P ICTP concentration remained unchanged , with a tendency to decrease . No changes occurred in the control subjects . Conclusions . Active back rehabilitation based on vigorous exercise increases Type I collagen synthesis in patients with chronic low back pain ; this may provide a means of objective ly verifying the effects of such rehabilitation",
"BACKGROUND AND PURPOSE This study compared the ability of the Rol and -Morris ( RM ) , Oswestry ( OSW ) , and Jan van Breemen Institute ( JVB ) pain and function question naires to detect change over time . SUBJECTS The sample consisted of 88 patients with mechanical low back pain who were referred by physicians to the outpatient physical therapy department of a teaching hospital . METHODS Question naires were completed by the subjects at their initial visit and 4 to 6 weeks later . Clinical ly important change was estimated by having the subject and the clinician independently complete two rating scales . Sensitivity to change was assessed using receiver operating characteristic ( ROC ) curve analysis . RESULTS The ROC curve areas for the RM ( 0.79 ) , OSW ( 0.78 ) , and JVB pain ( 0.79 ) question naires were significantly greater than for the JVB function question naire ( 0.66 ) . Blank and multiple responses per item were present on approximately 20 % of the OSW question naires and 14 % of the JVB question naires . Words rather than checks were evident on 3 % of the RM question naires . CONCLUSION AND DISCUSSION Based on the latter finding , we believe the RM question naire may be the preferred instrument for assessing change over time in patients with low back pain",
"& NA ; Chronic pain adversely affects individuals ' physical as well as emotional well‐being . A cognitive‐behavioral model has been proposed to explain the role of cognitive appraisal variables in mediating the development of emotional distress following pain of long duration . There is little evidence linking the prevalence of depression in chronic pain patients to life stage , but there are suggestions in the literature that the link between medical illness and depression may be stronger in elderly patients . One purpose of this study was to replicate the efficacy of a previous study of the cognitive‐behavioral mediation model in explaining the association between pain and depressed affect . A second purpose of this study was to extend the cognitive‐behavioral model to evaluate relationships among pain , cognitive appraisal variables , and depressive affect in the elderly chronic pain population . One hundred chronic pain patients were divided into two age groups ( ≤ 69 years and ≥ 70 years ) . A path analysis conducted for the total sample supported the cognitive‐behavioral mediation model of depression in chronic pain , in which cognitive appraisal variables mediate the pain‐depression relationship . Correlations among variables in each of the two age groups , however , revealed different patterns of association . Consistent with the cognitive‐behavioral model , the younger patients demonstrated a low and non‐significant correlation between pain severity and depression ( r = 0.01 ) . Conversely , a strong direct association was observed in the older patients between these variables ( r = 0.51 ) . These results suggest that the relationship between pain and depression varies substantially depending upon age cohort",
"Our purpose , in this prospect i ve clinical study , was to identify the best predictors of 2-month return to work or retraining for a group of low back injured subjects ( n = 40 ) who completed at least 8 weeks of a community-based rehabilitation program that combined aerobic and flexibility exercise conducted in the water ( aquafitness ) with muscle strength and endurance training . Baseline demographic characteristics and changes in physical fitness , pain , disability , and psychological well-being during the course of program participation were compared between two groups of low back injured subjects : those who returned to work ( RTW ) [ n = 24 ] , and those who did not ( N-RTW ) [ n = 16 ] . Subjects in both groups showed comparable improvement in measures of physical fitness at 8 weeks . However , multivariate analyses showed significant between-group differences in self-report measures . The RTW group showed significant improvement in measures of pain , disability , anxiety , and vigor while self-esteem and affect remained stable . The N-RTW group displayed no change in pain and disability variables and had significant deterioration in mean overall psychological well-being over time . The best predictors of return to work using logistic regression analyses were a first injury rather than a repeat injury to the lower back , and stability in self-esteem . Suggestions are offered for further research to examine the benefits of aquafit exercise for the low back injured , for additional interventions for those with a reinjury , and for maintaining or enhancing self-esteem as a treatment goal",
"OBJECTIVE To determine the relationship between overall disability in daily activities , assessed with the Pain Disability Index ( PDI ) and the Oswestry Disability Question naire ( ODQ ) , and impaired performance on three physical tests in patients with chronic low-back pain . DESIGN AND SUBJECTS The PDI and ODQ were administered in a cross-sectional study , before beginning a back rehabilitation program , to 45 patients with low-back pain of > or = 3 months ' duration , with or without radiation to the legs . All patients also performed repetitive sit-up , arch-up , and squatting tests . SETTING Tertiary care center . RESULTS Modestly significant ( p PDI and ODQ ( Wilcoxon 's two- sample test : p performance on all physical tests ( p self-perceived disability , and impaired performance on repetitive squatting , arch-up , and sit-up tests , as measures of physical capability , show some overlap in low-back-pain patients . Both types of disability measures are clearly influenced by the patient 's work status",
"The prevailing opinion seems to accept that the natural course of lumbar spinal stenosis is one of progressive worsening , and that only surgery can check this development . In fact , the choice of treatment for lumbar spinal stenosis is still an open question . The aim of this study was to compare in the matched-pair format the outcome of surgically and non-surgically treated patients with lumbar spinal stenosis . The surgically treated group consisted of 496 patients who were operated on during the period 1974 - 1987 and 440 of whom were re-examined an average of 4.1 years after surgery . The non-surgically treated group consisted of 57 patients who were treated conservatively during the period 1980 - 1987 and were re-examined an average of 4.3 years after the start of treatment . The matching criteria were sex , age , myelographic findings , major symptom and duration of symptoms . We were able to form 54 similar matched-pairs from the surgically and non-surgically treated patients . Subjective disability was assessed using the Oswestry question naire and functional status was evaluated during the clinical examination . For statistical analysis the McNemar test and the paired Student 's t-test were used . The overall results showed no statistical difference in outcome between the matched-pair groups , but the operated men fared significantly better than the non-operated men . The functional status was very good in both groups and for both sexes . In conclusion , conservative treatment of lumbar spinal stenosis should be considered for the patients with moderate stenosis . Controlled , prospect i ve and r and omized trials are needed to clarify better the choice of treatment in patients with lumbar stenosis",
"Study Design . A r and omized , controlled trial , test‐retest design , with a 3‐ , 6‐ , and 30‐month postal question naire follow‐up . Objective . To determine the efficacy of a specific exercise intervention in the treatment of patients with chronic low back pain and a radiologic diagnosis of spondylolysis or spondylolisthesis . Summary of Background Data . A recent focus in the physiotherapy management of patients with back pain has been the specific training of muscles surrounding the spine ( deep abdominal muscles and lumbar multifidus ) , considered to provide dynamic stability and fine control to the lumbar spine . In no study have research ers evaluated the efficacy of this intervention in a population with chronic low back pain where the anatomic stability of the spine was compromised . Methods . Forty‐four patients with this condition were assigned r and omly to two treatment groups . The first group underwent a 10‐week specific exercise treatment program involving the specific training of the deep abdominal muscles , with co‐activation of the lumbar multifidus proximal to the pars defects . The activation of these muscles was incorporated into previously aggravating static postures and functional tasks . The control group underwent treatment as directed by their treating practitioner . Results . After intervention , the specific exercise group showed a statistically significant reduction in pain intensity and functional disability levels , which was maintained at a 30‐month follow‐up . The control group showed no significant change in these parameters after intervention or at follow‐up . Summary . A \" specific exercise \" treatment approach appears more effective than other commonly prescribed conservative treatment programs in patients with chronically symptomatic spondylolysis or spondylolisthesis",
"OBJECTIVE To assess the efficacy of a back school program for patients with a first episode of acute work-related low back pain requiring compensation . DESIGN A r and omized single-blind controlled trial . SETTING A private physiatrics outpatient clinic . PATIENTS The mean duration of low back pain was 15 days . INTERVENTION Eligible patients were r and omized to a st and ard treatment program that included daily physiotherapy ( n = 86 ) or the same program with the addition of back school ( n = 82 ) . The back school program consisted of three 90-minute sessions given by a single trained instructor at 0 , 1 , and 8 weeks . MAIN OUTCOME MEASURES The primary outcomes were the time off work for the presenting episode of back pain and the number and duration of recurrences in the year following the study onset . Secondary outcomes included the level of pain , spinal mobility , active straight-leg raising , and functional disability assessed by the Oswestry and Rol and -Morris scales . RESULTS Those r and omized to the back school group gained significantly more knowledge , based on the multiple choice examination ( p = .0001 ) and performed the exercise program significantly better ( p = .0001 ) than the st and ard care group . There were no differences between the two treatment groups for either of the primary outcomes . The median time to return to work from r and omization was 33 days for both the back school and the st and ard care groups ( p = .48 ) . The number of compensated recurrences of low back pain over 1 year was similar ( back school = 14 , st and ard care = 10 , p = .16 ) , as was the median duration of these episodes ( back school = 25 days , st and ard care = 70 days , p = .21 ) . There were no significant differences favoring the back school group for any of the secondary outcomes at the posttreatment , 6-month , or 12-month assessment s. CONCLUSION A back school intervention in addition to st and ard care result ed in no reduction in the time to return to work or the number or duration of recurrences of low back pain requiring compensation over a period of one year",
"OBJECTIVE To undertake a comparative examination of the reliability and validity of two frequently used self-report measures of functional disability , the Pain Disability Index ( PDI ) and the Oswestry Low Back Pain Disability Question naire ( OLBPDQ ) . DESIGN A descriptive ex-post facto design was used in the study . SETTING Pain clinics and neurosurgical units at three metropolitan hospitals . SUBJECTS One hundred patients with chronic low back pain of noncancer origin were administered the two question naires as part of a larger question naire battery . RESULTS Acceptable internal consistency values of 0.76 for the PDI and 0.71 for the OLBPDQ were obtained . A correlation of r = 0.63 was found between the PDI and the OLBPDQ , supporting the concurrent validity of the two scales . Both the scales were found to be correlated to the Beck Depression Inventory scores ( PDI , r = 0.42 ; OLBPDQ , r = 0.39 ) , with higher disability associated with greater depression . Only the total PDI score was found to be sensitive to functional status differences within the patient sample . CONCLUSIONS These findings support other recent work in favor of the PDI . The PDI had a slightly higher internal consistency and was more sensitive than the OLBPDQ",
"BACKGROUND AND PURPOSE The efficacy of a physical therapy outpatient program with multiple interventions to treat low back pain in subjects receiving workers ' compensation was examined . The primary purpose of the study was to describe the level of disability , physical impairment , and rate of return to work for compensated patients . SUBJECTS One hundred thirty-eight patients ( 84 male , 54 female ) , aged 17 to 63 years ( mean = 38 , SD = 10 ) , were evaluated prospect ively . METHODS Subjects were assessed initially ( INA ) and were reevaluated 1 month later ( 1MO ) and again at the time of discharge ( DC ) . The Oswestry disability score , fingertip-to-floor distance during forward bending , maximal isometric lift , and work status were described as outcomes . Subjects were grouped based on compliance , chronicity , and leg symptoms . Each disability/impairment outcome was analyzed with paired t tests ( INA versus 1MO and INA versus DC ) . The frequency of subjects returning to work across groups was evaluated with a chi-square analysis corrected for unequal group sizes . RESULTS Overall , there was improvement in each dependent measure at 1MO and DC compared with the INA . Subjects with high compliance had a 10 % reduction in mean disability at 1MO and a 12 % reduction in mean disability at DC compared with the INA . The low-compliance group , in contrast , showed less than a 5 % reduction in mean disability at both the 1MO and DC assessment s compared with the INA . The magnitude of improvement in disability status , forward bending , and maximal lift was approximately two to three times greater for subjects with acute symptoms compared with those with chronic symptoms . The increase in mean forward bending for subjects without leg symptoms was over twice as large as the increase in forward bending for subjects with leg symptoms . Seventy-five percent of the subjects followed at DC ( 30 out of 40 ) were released to work in some capacity . There was no association between compliance or presence of leg symptoms and work status at DC . Eighty percent of the subjects with acute symptoms , however , were working at the time of DC compared with 44 % of those with chronic symptoms . CONCLUSION AND DISCUSSION Compliance , chronicity , and leg symptoms are all factors that can affect the outcome of physical therapy . The positive outcomes for subjects who complied with therapy suggest that a physical therapy program with multiple interventions may decrease disability and impairment",
"Study Design . A r and omized trial was conducted in which patients with back and neck pain , visiting a general practitioner , were allocated to chiropractic or physiotherapy . Objectives . To compare outcome and costs of chiropractic and physiotherapy as primary treatment for patients with back and neck pain , with special reference to subgroups , recurrence rate , and additional health care use at follow‐up evaluation 12 months after treatment . Summary of Background Data . Earlier studies on the effect of spinal manipulation have shown inconsistent results . Mostly they include only short‐term follow‐up periods , and few cost‐effectiveness analyses have been made . Methods . A group of 323 patients aged 18‐60 years who had no contraindications to manipulation and who had not been treated within the previous month were included . Outcome measures were changes in Oswestry scores , pain intensity , and general health ; recurrence rate ; and direct and indirect costs . Results . No differences were detected in health improvement , costs , or recurrence rate between the two groups . According to Oswestry score , chiropractic was more favorable for patients with a current pain episode of less than 1 week ( 5 % ) and physiotherapy for patients with a current pain episode of greater than 1 month ( 6.8 % ) . Nearly 60 % of the patients reported two or more recurrences . More patients in the chiropractic group ( 59 % ) than in the physiotherapy group ( 41 % ) sought additional health care . Costs varied considerably among individuals and subgroups ; the direct costs were lower for physiotherapy in a few subgroups . Conclusions . Effectiveness and costs of chiropractic or physiotherapy as primary treatment were similar for the total population , but some differences were seen according to subgroups . Back problems often recurred , and additional health care was common . Implication s of the result are that treatment policy and clinical decision models must consider subgroups and that the problem often is recurrent . Models must be implemented and tested",
"The present study focuses on the long-term prognosis of radiographically verified stenosis of the lower lumbar spine . The purpose here was to describe the outcome 12 years after radiographic diagnosis of spinal stenosis and to identify factors predicting disability after operative or conservative treatment . Data were compiled on 75 patients ( 43 men and 32 women ) with changes in functional myelography diagnostic for spinal stenosis . Their mean age at the interview 12 years later was 61 years . The sagittal diameter of the dural sac was measured from baseline myelographs at all intervertebral levels and was corrected for magnification . In the interview , subjective outcome assessment was obtained with a structured question naire , and the low-back disorder was scored using the Oswestry disability index . The sagittal diameter of the dural sac was severely stenotic ( disability , even when the effects of age , sex , therapy regimen , and body mass index were adjusted for . For moderate and severe stenosis , the adjusted mean Oswestry indices were 28.4 and 39.1 , respectively ( p = 0.01 ) . Therapy as such ( operative versus nonoperative ) did not significantly correlate with later disability . The radiographic severity of lumbar spinal stenosis predicts disability independently of therapy regimen . R and omized clinical trials are needed to establish the indications for surgical and conservative treatment . Radiographic severity of the stenosis should be considered as an effect-modifying or confounding factor in clinical trials and other studies focusing on the outcome of lumbar spinal stenosis",
"Study Design . A multicenter , r and omized , single‐blinded controlled trial with 1‐year follow‐up . Objectives . To evaluate the efficiency of progressively grade d medical exercise therapy , conventional physiotherapy , and self‐exercise by walking in patients with chronic low back pain . Summary and Background Data . Varieties of medical exercise therapy and conventional physiotherapy are considered to reduce symptoms , improve function , and decrease sickness absence , but this opinion is controversial . Methods . Patients with chronic low back pain or radicular pain sick‐listed for more than 8 weeks and less than 52 weeks ( Sickness Certificate II ) were included . The treatment lasted 3 months ( 36 treatments ) . Pain intensity , functional ability , patient satisfaction , return to work , number of days on sick leave , and costs were recorded . Results . Of the 208 patients included in this study , 71 were r and omly assigned to medical exercise therapy , 67 to conventional physiotherapy , and 70 to self‐exercise . Thirty‐three ( 15.8 % ) patients dropped out during the treatment period . No difference was observed between the medical exercise therapy and conventional physiotherapy groups , but both were significantly better than self‐exercise group . Patient satisfaction was highest for medical exercise therapy . Return to work rates were equal for all 3 intervention groups at assessment 15 months after therapy was started , with 123 patients were back to work . In terms of costs for days on sick leave , the medical exercise therapy group saved 906,732 Norwegian Kroner ( NOK ) ( $ 122,531.00 ) , and the conventional physiotherapy group saved NOK 1,882,560 ( $ 254,200.00 ) , compared with the self‐exercise group . Conclusions . The efficiency of medical exercise therapy and conventional physiotherapy is shown . Leaving patients with chronic low back pain untampered poses a risk of worsening the disability , result ing in longer periods of sick leave",
"Aspects of validity are investigated with a brief functional assessment measure among out patients undergoing rehabilitation for musculoskeletal problems . The Medical Rehabilitation Follow Along measure ( MRFA ) currently has screening , musculoskeletal , neurologic , and multiple sclerosis forms . In this study , the 31-item musculoskeletal form of the MRFA is compared with and contrasted to a measure of general health status , the Medical Outcomes Trust SF-36 . Content , construct , and criterion validity are addressed using scale scores before ( n = 94 ) and after ( n = 48 ) outpatient rehabilitation . Scale scores are compared with therapists ' ratings of improvement . The results provide support for the validity of inferences made from scale scores of the MRFA for persons with musculoskeletal problems . Applications of the MRFA , including screening , monitoring , and outcome assessment are discussed for clinical management , measuring treatment effectiveness , and program evaluation",
"There are only few publications about the effect of music therapy on pain relief . The intention of this prospect i ve study is to demonstrate the influence of the Nordoff/Robbins method of active music therapy in a group of 12 patients with fibromyalgia , myofascial pain syndromes and polyarthritis on pain reduction , life quality and coping . The clinical parameters of each patient were related to the observations in the audio- and video-documented music therapy setting s and to the self-reported changes in pain intensity and pain behaviour . There was a significant reduction of pain intensity and pain-related disability in the music group compared to a control group , but no change in the depression and anxiety score . The influence of music therapy could be even better demonstrated in the systematic analysis of the single cases by individual profiles . Active music therapy affects especially the communicative and emotional dimension of chronic pain . Psychophysiological and psychodynamic models are presented to explain the effectiveness of music therapy on pain reduction . Clinical studies on music therapy as well as on other \" art therapies \" should relate the analysis of clinical parameters to the descriptive-phenomenological documentation of the therapeutic process to demonstrate systematic ally the influence of music and art in the individual case",
"Cognitive behavioral treatment has been incorporated into st and ard medical treatment procedures in German pain centers . Acceptance of the treatment by patients and outcome in terms of pain , coping , and disability was investigated . Components of the psychological treatment are education , relaxation and imagery , modifying thoughts and feelings , enhancement of pleasant activities , and training of good postural habits . The program was conducted in a group setting in accordance with a treatment manual and consists of 12 weekly 2.5-h sessions . A two-factor experiment with repeated measures on one factor was applied . Ninety-four consecutive patients with low-back pain were r and omly assigned to an experimental group having a combined medical and cognitive-behavioral treatment , or to a control group with medical treatment only . Assessment s were taken pre-treatment , post-treatment , and --in the treated group only -- at a 6-months follow-up . At each assessment , patients kept a pain diary over a period of 4 weeks , and filled in self-report question naires . The sample consisted of 36 experimental and 40 control subjects at post-treatment . Experimental subjects reported less pain , better control over pain , more pleasurable activities and feelings , less avoidance and less catastrophizing . In addition , disability was reduced in terms of social roles , physical functions and mental performance . The results were maintained at follow-up . Patients who only received medical treatment showed little improvement . Data indicate that the program meets the needs of the patients and should be continued",
"Low Back Pain Rating scale is an index scale which includes measurements of pain intensity , disability , and physical impairment . The scale was design ed to monitor the outcome of clinical trials of low back pain treatment . It has been vali date d in 58 patients following first-time discectomy . The scale rating can be rapidly carried out and requires no special aids . With slight modification it can be used in office and telephone interviews , as well as postal question naires . These modifications only slightly reduce the quantity of information gathered . In the study , a high rater agreement ( 97.7 % ) was found without level difference between two observers using the scale . The validation process included : construct validity , criterion-related validity and item bias , relative to Global Assessment s pronounced by the patient and an experienced clinician . Low Back Pain Rating scale hs been shown to be valid and reliable in the assessment of low back pain",
"BACKGROUND Bed rest and back-extension exercises are often prescribed for patients with acute low back pain , but the effectiveness of these two competing treatments remains controversial . METHODS We conducted a controlled trial among employees of the city of Helsinki , Finl and , who presented to an occupational health care center with acute , nonspecific low back pain . The patients were r and omly assigned to one of three treatments : bed rest for two days ( 67 patients ) , back-mobilizing exercises ( 52 patients ) , or the continuation of ordinary activities as tolerated ( the control group ; 67 patients ) . Outcomes and costs were assessed after 3 and 12 weeks . RESULTS After 3 and 12 weeks , the patients in the control group had better recovery than those prescribed either bed rest or exercises . There were statistically significant differences favoring the control group in the duration of pain , pain intensity , lumbar flexion , ability to work as measured subjectively , the Oswestry back-disability index , and number of days absent from work . Recovery was slowest among the patients assigned to bed rest . The overall costs of care did not differ significantly among the three groups . CONCLUSIONS Among patients with acute low back pain , continuing ordinary activities within the limits permitted by the pain leads to more rapid recovery than either bed rest or back-mobilizing exercises",
"Study Design A prospect ively design ed study was performed to assess the influence of employment status and a compensation cl aim on patients experiencing low back pain . Objectives To determine the factor that most influences disability arising from low back pain , unemployment or a compensation cl aim . Summary of Background Data Two hundred sixtynine consecutive patients were assessed from a low back pain clinic . Methods Disability was assessed using the Oswestry Disability Score , and employment , and compensation status were recorded . Results Both unemployment and patients involved in compensation had higher disability scores . However , by controlling the data for employment and assessing only the compensation group it was found that those cl aim ing compensation , but still working had significantly less disability than those cl aim ing compensation who were unemployed . Conclusions Both unemployment and compensation cl aims influence disability , but employment status is the most important factor",
"Study Design This prospect i ve , multicenter study was design ed to investigate the efficacy and outcome of spinal cord stimulation using a variety of clinical and psychosocial outcome measures . Data were collected before implantation and at regular intervals after implantation . This report focuses on 70 patients who had undergone 1 year of follow‐up treatment at the time of data analysis . Objectives To provide a more generalizable assessment of long‐term spinal cord stimulation outcome by comparing a variety of pain and functional/ quality ‐of‐life measures before and after management . This report details results after 1 year of stimulation . Summary of Background Data The historically diverse methods , patient selection criteria , and outcome measures reported in the spinal cord stimulation literature have made interpretation and comparison of results difficult . Although short‐term outcomes are generally consistent , long‐term outcomes of spinal cord stimulation , as determined by prospect i ve studies that assess multidimensional aspects of the pain complaint among a relatively homogeneous population , are not well established . Methods Two hundred nineteen patients were entered at six centers throughout the United States . All patients underwent a trial of stimulation before implant of the permanent system . Most were psychologically screened . One hundred eighty‐two patients were implanted with a permanent stimulating system . At the time of this report , complete 1‐year follow‐up data were available on 70 patients , 86 % of whom reported pain in the back or lower extremities . Patient evaluation of pain and functional levels was completed before implantation and 3 , 6 , 12 , and 24 months after implantation . Complications , medication usage , and work status also were monitored . Results All pain and quality ‐of‐life measures showed statistically significant improvement during the treatment year . These included the average pain visual analogue scale , the McGill Pain Question naire , the Oswestry Disability Question naire , the Sickness Impact Profile , and the Beck Depression Inventory . Overall success of the therapy was defined as at least 50 % pain relief and patient assessment of the procedure as fully or partially beneficial and worthwhile . Using this definition , spinal cord stimulation successfully managed pain in 55 % of patients on whom 1‐year follow‐up is available . Complications requiring surgical intervention were reported by 17 % ( 12 of 70 ) of patients . Medication usage and work status were not changed significantly . Conclusions This prospect i ve , multicenter study confirms that spinal cord stimulation can be an effective therapy for management of chronic low back and extremity pain . Significant improvements in many aspects of the pain condition were measured , and complications were minimal",
"Abstract A new measure is presented , suitable for documenting severity and response to treatment in chronic low‐back pain syndromes . It is self‐administered and combines two pain and seven mobility items . These were selected from pre‐existing vali date d instruments on the basis of their sensitivity to change after treatment . Their Italian vali date d translation was adopted . The measure was administered to 32 chronic low‐back pain Italian patients , all refractory to previous conservative treatments . In most cases they presented with herniation or protrusion of 1–3 lumbar discs . Patients were treated with 3–6 sessions of autotraction over a 5‐ to 15‐day period . Scores on the scale were recorded at admission , discharge and follow‐up , 1–3 months after treatment . At discharge and at follow‐up , patients were asked if , overall , they felt improved , the same or worse . At follow‐up , 20 patients out of 32 reported overall improvement . Scalometric properties of the measure were tested using Rasch analysis . For admission and follow‐up , items followed a consistent hierarchical relationship along a unidimensional pain/disability variable , which is being called back illness . The items were not redundant , in that they spread well along a wide range of difficulty/severity . The hierarchy matched well with the expected expression of the conditions of the patients . A study was conducted on 34 chronic back pain patients , showing satisfactory test‐retest reliability . Depending on the various items , Cohen 's unweighted K ranged from 0.27 to 0.78 , with ten of the 11 items above the 0.45 level of acceptability , while intraclass correlation coefficients ranged from 0.42 to 0.89 . At follow‐up , changes in BACKILL of plus 15 % or more , with respect to admission , were consistent with patients ' reports of improvement in 19 out of 20 cases . Changes in BACKILL of less than 15 % were consistent with patients reports of being the same or worse in 11 out of 12 cases",
"Intradevice reliability of isokinetic trunk strength measurements has been studied frequently , but no evidence is available on interdevice reliability . This motivated the present study , in which two isokinetic devices , the Ariel 5000 and Lido Multi-Joint II , were compared in a sample of 41 subjects ( 20 healthy and 21 low back pain subjects ) . The measurements were made in a r and om order with both machines . The results showed that the two isokinetic machines gave quite different results in trunk flexion-extension strength measurements . A statistically significant difference was present in the average peak torques between the two devices , with the exception of flexion at low angular velocity ( 60 degrees/s ) , and the correlations between the two measurements were low . The results were assumed to be more of a reflection of the interdevice variations ( hardware and software , attachment of the subject ) than of learning effects or other phenomena . We conclude that isokinetic trunk-muscle strength test results with the Ariel and Lido are device specific , and one can not automatically compare results obtained from different devices with each other",
"This is the report of a feasibility study of a r and omised controlled trial of chiropractic and hospital outpatient management for low back pain of mechanical origin . Preparations for the study included an approach to the General Medical Council for guidance about the intended collaboration between medically qualified and heterodox practitioners , detailed communication with local general practitioners , and the provision of a Medical Research Council ( MRC ) grant to cover payments to the chiropractors for work carried out in the course of the study . A total of 238 patients were considered , 197 of whom had initially presented to Northwick Park Hospital and the remaining 41 to the chiropractic clinic in Harrow . Only 6 % of the patients presenting to the hospital refused to enter . The single most frequent reason for in eligibility in the hospital patients was freedom from pain at the time of the first hospital visit ( 23 % ) . A variety of medical contraindications accounted for the exclusion of a further 24 % of hospital patients . Patients presenting to the chiropractic group tended to have had shorter current episodes of back pain but to have had more NHS treatment in the past than those presenting to hospital . The commonest reason for exclusion among those presenting to the chiropractic clinic was refusal to enter ( 34 % ) . Only 5 % of the chiropractic patients were ineligible for medical reasons . Overall , 16 % of those presenting to hospital and 44 % of those presenting to the chiropractors were eligible and willing to enter the r and omised treatment phase of the study . Of the 50 patients who entered the treatment phase , all but seven completed treatment and the six weekly self-completed assessment s of progress . Patients whose current episodes had lasted less than a month progressed significantly more rapidly than those with longer current episodes . It is likely that sufficient numbers of patients with low back pain are prepared to take part in a formal r and omized controlled trial . The organization and working methods for such a trial appear to be feasible . A full scale multicentre trial should aim to include about 2000 patients ",
"In a prospect i ve study 122 patients with herniated lumbar disc pre-operatively completed psychological question naires . Surgical outcome was evaluated 12 months post-operatively mainly by a composite clinical overall score ( COS ) , and by its separate elements . Anxiety ( HAD-A scale ) and psychosomatic symptoms ( MSPQ ) had predictive value : fewer symptoms favoured a satisfactory overall outcome , and vice versa . The HAD-A Scale had a predictive power of poor ( ppp ) and satisfactory ( pps ) outcome of 28 and 81 % , respectively . Correspondingly , for the MSPQ , the ppp and pps were 42 and 85 % . Anamnestic and biological variables ( including fibrinolytic variables : ECLT and PAI-1 ) predicted 20 % of the outcome . By adding all psychological variables the prediction increased only to 24 % , but the HAD-A Scale and the MSPQ were still significant . The results suggest that in order to further improve prediction of outcome , future studies should combine biological variables sensitive to the mental state of the patient , with psychometric assessment",
"Abstract Objective : To compare the effectiveness over three years of chiropractic and hospital outpatient management for low back pain . Design : R and omised allocation of patients to chiropractic or hospital outpatient management . Setting : Chiropractic clinics and hospital outpatient departments within reasonable travelling distance of each other in 11 centres . Subjects : 741 men and women aged 18 - 64 years with low back pain in whom manipulation was not contraindicated . Outcome measures : Change in total Oswestry question naire score and in score for pain and patient satisfaction with allocated treatment . Results : According to total Oswestry scores improvement in all patients at three years was about 29 % more in those treated by chiropractors than in those treated by the hospitals . The beneficial effect of chiropractic on pain was particularly clear . Those treated by chiropractors had more further treatments for back pain after the completion of trial treatment . Among both those initially referred from chiropractors and from hospitals more rated chiropractic helpful at three years than hospital management . Conclusions : At three years the results confirm the findings of an earlier report that when chiropractic or hospital therapists treat patients with low back pain as they would in day to day practice those treated by chiropractic derive more benefit and long term satisfaction than those treated by hospitals",
"Study Design . A r and omized , clinical trial was conducted in which patients with back/neck problems , visiting a general practitioner , were allocated to chiropractic or physiotherapy as primary management . Objectives . To compare outcome and costs of chiropractic and physiotherapy in managing patients with low back or neck pain . Summary of Background Data . Earlier studies on the treatment of back pain by spinal manipulation have shown inconsistent results . When a \" new \" strategy ‐chiropractic‐in the treatment of back pain was introduced in public health care in Sweden , there was a need to compare the effects and costs of chiropractic with the established physiotherapy . Methods . Three hundred twenty‐three patients aged 18 to 60 years who had no contraindications to manipulation and who had not been treated within the previous month were included in the study . Treatment was carried out at the discretion of the therapist . Outcome measures were primarily changes in pain intensity and general health , both assessed with visual analog scale and Oswestry pain disability question naire . Direct and indirect costs were measured . Results . For patients with low back or neck pain visiting the general practitioner in primary care , both chiropractic and physiotherapy as primary treatment reduced the symptoms . No difference in outcome or direct or indirect costs between the two groups could be seen , nor in subgroups defined as duration , history , or severity . Conclusions . The effectiveness and total costs of chiropractic or physiotherapy as primary treatment were similar to reach the same result after treatment and after 6 months"
] | 411637a6-06ff-11f0-808a-c43d1ab1c353 |
Abstract Background : A systematic review and meta- analysis was design ed to evaluate the effect of probiotics on diabetes and its associated risk factors . Methods : We systematic ally search ed the Cochrane Library , PubMed , EMBASE and Web of Science to June 2016 . We also h and - search ed the citation lists of included studies and previously identified systematic review s to identify further relevant trials . Our primary outcome variables included glucose , glycated hemoglobin ( HbA1c ) and insulin . The pooled st and ardized mean difference was used to compare the effect between the probiotics and controlled groups , and the pooled st and ardized mean difference effect size with a 95 % confidence interval ( CI ) was estimated using a r and om-effect model . Heterogeneity was assessed with Cochran ’s Q and Higgins I2 tests . Two review ers assessed trial quality and extracted data independently . The analysis and bias for each included study was performed and assessed using Review Manager 5.2 . Results : Eighteen r and omized , placebo-controlled studies ( n=1056 participants , 527 consuming probiotics , 529 not consuming probiotics ) were included for analysis . Comparing the probiotics groups with the control groups , there were statistically significant pooled st and ardized mean differences on the reduction of glucose ( −0.61 , 95 % CI −0.98 , −0.24 ; p=0.001 ) , insulin ( −0.49 , 95 % CI −0.93 , −0.04 ; p=0.03 ) and HbA1c ( −0.39 , 95 % CI −0.60 , −0.19 % ; p=0.0001 ) . Subgroup analysis also indicated statistical significance on the reduction of low-density lipoprotein cholesterol ( LDL-C ) in non-type 2 diabetes ( non-T2DM ) mellitus patients with diabetes , for the pooled st and ardized mean difference was −0.29 ( 95 % CI −0.54 , −0.04 ; p=0.02 ) . Conclusions : Probiotics may have beneficial effects on the reduction of glucose , insulin and HbA1c for diabetes , especially for T2DM mellitus patients | [
"Background : Alteration in plasma lipid and lipoprotein profile has been documented in diabetic patients . The purpose of this study was to compare the effect of probiotic and conventional yogurt on lipid profile in type 2 diabetes mellitus patients . Material s and Methods : A total of 44 patients with type 2 diabetes aged 30 - 60 years old who had low density lipoprotein cholesterol ( LDL-c ) ≥100 mg/dl enrolled in this r and omized , double – blind controlled trial and were assigned to two intervention and control groups . The subjects in the intervention group consumed 300 g/d probiotic yogurt containing Lactobacillus acidophilus La-5 and Bifidobacterium lactis Bb-12 and subjects in the control group consumed 300 g/d conventional yogurt for 8 weeks . Anthropometric indices , dietary intake , and serum lipid profile were evaluated at the beginning and end of the intervention . Independent- sample t-test , paired sample t-test , ANCOVA , and repeated measures were used for statistical analysis . Results : The consumption of probiotic yogurt caused significant decrease in LDL-c/high density lipoprotein cholesterol ( HDL-c ) ratio ( 3.13 ± 1.00 - 2.07 ± 0.71 , P = 0.016 ) . The levels of HDL-c were increased significantly ( 43.66 ± 6.80 - 50.42 ± 6.64 , P = 0.023 ) in the intervention group postintervention . However , there were no significant differences in triglyceride and total cholesterol levels between two groups postintervention ( P that probiotic yogurt consumption may be used as an alternative prevention approach and treatment method to improve dyslipidemia in patients with type 2 diabetes",
"Background Although several studies have found probiotics encouraging in prevention of gestational diabetes mellitus ( GDM ) , the evidence for the use of probiotics in diagnosed GDM is largely limited . The aim of this study was to assess the effect of a probiotic supplement capsule containing four bacterial strains on glucose metabolism indices and weight changes in women with newly diagnosed GDM . Methods Sixty-four pregnant women with GDM were enrolled into a double-blind placebo-controlled r and omized clinical trial . They were r and omly assigned to receive either a probiotic or placebo capsule along with dietary advice for eight consecutive weeks . The trend of weight gain along with glucose metabolism indices was assayed . Results During the first 6 weeks of the study , the weight gain trend was similar between the groups . However , in the last 2 weeks of the study , the weight gain in the probiotic group was significantly lower than in the placebo group ( p Fasting blood sugar ( FBS ) decreased in both intervention ( from 103.7 to 88.4 mg/dl ) and control ( from 100.9 to 93.6 mg/dl ) groups significantly , and the decrease in the probiotic group was significantly higher than in the placebo group ( p Insulin resistance index in the probiotic group had 6.74 % reduction over the study period ( p insulin resistance index ( 6.45 % ) , but the observed change in insulin resistance was not statistically significant . Insulin sensitivity index was increased in both groups . The post-intervention insulin sensitivity index in the probiotic group was not significantly different from placebo when adjusted for the baseline levels . Conclusions The probiotic supplement appeared to affect glucose metabolism and weight gain among pregnant women with GDM . This needs to be confirmed in other setting s before a therapeutic value could be approved",
"To our knowledge , no reports are available indicating the favorable effects of synbiotic bread consumption on blood lipid profiles among patients with type 2 diabetes mellitus ( T2DM ) . This study was conducted to evaluate the effects of the daily consumption of synbiotic bread on blood lipid profiles of patients with T2DM . This r and omized double-blinded controlled clinical trial was performed with 78 diabetic patients , aged 35–70 years . After a 2-week run-in period , subjects were r and omly assigned to consume either synbiotic ( n = 26 ) , probiotic ( n = 26 ) or control bread ( n = 26 ) for 8 weeks . The synbiotic bread contained viable and heat-resistant probiotic Lactobacillus sporogenes ( 1 × 108 CFU ) and 0.07 g inulin ( HPX ) as prebiotic per 1 g. The probiotic bread contained L. sporogenes ( 1 × 108 CFU ) per 1 g. Patients were asked to consume the synbiotic , probiotic and control breads three times a day in a 40 g package for a total of 120 g/day . Biochemical measurements including blood lipid profiles were conducted before and after 8 weeks of intervention . Consumption of the synbiotic bread , compared to the probiotic and control breads , led to a significant decrease in serum TAG ( P = 0.005 ) , VLDL-C ( P = 0.005 ) , TC/HDL-C ( P = 0.002 ) and a significant increase in serum HDL-C levels ( P = 0.01 ) . No significant effect of synbiotic bread consumption on FPG , TC , LDL-C and non-HDL-C levels was seen compared to the probiotic and control breads ( P > 0.05 ) . Trial registry code : http://www.i rct .ir I RCT 201311215623N13",
"Background : The dramatic increase in the incidence of diabetes and its associated complications require a natural and safe solution to control and delay such complications . The present study tested the hypothesis that probiotics may affect biochemical indices of diabetic patients Methods : Thirty four types 2 diabetic patients aged between 25 to 65 years , and diagnosed with diabetes for less than 15 years were selected for this single- blinded clinical trial . Using balanced block r and om sampling , the patients were divided into two groups of intervention ( probiotics ) and placebo . Blood sample s tested for baseline glucose , insulin , TG , total cholesterol , LDL-C , HDL-C , malondialdehyde , high sensitive CRP ( hs-CRP ) and IL-6 . After six weeks of experiment , fasting blood sample s were re-tested and the data obtained were analyzed using SPSS software . Results : There were no significant differences between anthropometric data including body mass index and waist to hip ratio in placebo and treatment groups . There was no significant difference in FBS , Serum TG concentration total cholesterol and LDL-C levels between placebo and treatment groups . HDL-C levels were slightly elevated after probiotic treatment , which were not statistically significant . Insulin , MDA and IL-6 levels were reduced and high sensitive CRP hs . CRP levels were elevated , although , not statistically significant . Conclusion : The result of this study indicates a non- significant declining trend in the level of TG , MDA and IL-6 and insulin resistance after consumption of probiotics",
"According to animal studies , intake of probiotic bacteria may improve glucose homeostasis . We hypothesised that probiotic bacteria improve insulin sensitivity by attenuating systemic inflammation . Therefore , the effects of oral supplementation with the probiotic bacterium Lactobacillus acidophilus NCFM on insulin sensitivity and the inflammatory response were investigated in subjects with normal or impaired insulin sensitivity . In a double-blinded , r and omised fashion , forty-five males with type 2 diabetes , impaired or normal glucose tolerance were enrolled and allocated to a 4-week treatment course with either L. acidophilus NCFM or placebo . L. acidophilus was detected in stool sample s by denaturating gradient gel electrophoresis and real-time PCR . Separated by the 4-week intervention period , two hyperinsulinaemic-euglycaemic clamps were performed to estimate insulin sensitivity . Furthermore , the systemic inflammatory response was evaluated by subjecting the participants to Escherichia coli lipopolysaccharide injection ( 0·3 ng/kg ) before and after the treatment course . L. acidophilus NCFM was detected in 75 % of the faecal sample s after treatment with the probiotic bacterium . Insulin sensitivity was preserved among volunteers in the L. acidophilus NCFM group , whereas it decreased in the placebo group . Both baseline inflammatory markers and the systemic inflammatory response were , however , unaffected by the intervention . In conclusion , intake of L. acidophilus NCFM for 4 weeks preserved insulin sensitivity compared with placebo , but did not affect the systemic inflammatory response ",
"Background The consumption of foods containing probiotic and prebiotic ingredients is growing consistently every year , and in view of the limited number of studies investigating their effect in the elderly . Objective The objective of this study was to evaluate the effect of the consumption of a symbiotic shake containing Lactobacillus acidophilus , Bifidobacterium bifidum and fructooligosaccharides on glycemia and cholesterol levels in elderly people . Methods A r and omized , double-blind , placebo-controlled study was conducted on twenty volunteers ( ten for placebo group and ten for symbiotic group ) , aged 50 to 60 years . The criteria for inclusion in the study were : total cholesterol > 200 mg/dL ; triglycerides > 200 mg/dL and glycemia > 110 mg/dL. Over a total test period of 30 days , 10 individuals ( the symbiotic group ) consumed a daily dose of 200 mL of a symbiotic shake containing 108 UFC/mL Lactobacillus acidophilus , 108 UFC/mL Bifidobacterium bifidum and 2 g oligofructose , while 10 other volunteers ( the placebo group ) drank daily the same amount of a shake that did not contain any symbiotic bacteria . Blood sample s were collected 15 days prior to the start of the experiment and at 10-day intervals after the beginning of the shake intake . The st and ard lipid profile ( total cholesterol , triglycerides and HDL cholesterol ) and glycemia , or blood sugar levels , were evaluated by an enzyme colorimetric assay . Results The results of the symbiotic group showed a non-significant reduction ( P > 0.05 ) in total cholesterol and triglycerides , a significant increase ( P HDL cholesterol and a significant reduction ( P fasting glycemia . No significant changes were observed in the placebo group . Conclusion The consumption of symbiotic shake result ed in a significant increase in HDL and a significant decrease of glycemia . Trial Registration Clinical Trials.gov :",
"Background : Diabetes is a global health problem in the world . Probiotic food has anti-diabetic property . The aim of this trial was to determine the effect of probiotic fermented milk ( kefir ) on glucose and lipid profile control in patients with type 2 diabetes mellitus . Methods : This r and omized double-blind placebo-controlled clinical trial was conducted on 60 diabetic patients aged 35 to 65 years . Patients were r and omly and equally ( n=30 ) assigned to consume either probiotic fermented milk ( kefir ) or conventional fermented milk ( dough ) for 8 weeks . Probiotic group consumed 600 ml/day probiotic fermented milk containing Lactobacillus casei , Lactobacillus acidophilus and Bifidobacteria and control group consumed 600 ml/day conventional fermented milk . Blood sample s tested for fasting blood glucose , HbA1C , triglyceride ( TG ) , total cholesterol , HDL-C and LDL-C at the baseline and end of the study . Results : The comparison of fasting blood glucose between two groups after intervention was statistically significant ( P=0.01 ) . After intervention , reduced HbA1C compared with the baseline value in probiotic fermented milk group was statistically significant ( P=0.001 ) , also the HbA1C level significantly decreased in probiotic group in comparison with control group ( P=0.02 ) adjusting for serum levels of glucose , baseline values of HbA1c and energy intake according to ANCOVA model . Serum triglyceride , total cholesterol , LDL-cholesterol and HDL- cholesterol levels were not shown significant differences between and within the groups after intervention . Conclusion : Probiotic fermented milk can be useful as a complementary or adjuvant therapy in the treatment of diabetes",
"Many studies have been done on the hypocholesterolaemic effect of probiotic yoghurt . The results , however , are not conclusive . The aim of the present study was to test the effect of probiotic and conventional yoghurt on the lipid profile in women . In a r and omised trial , ninety female volunteers aged 19 - 49 years were assigned to three groups . Subjects consumed daily 300 g probiotic yoghurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 or 300 g conventional yoghurt or no yoghurt for 6 weeks . Fasting blood sample s , 3 d dietary records and anthropometric measurements were collected at baseline ( T1 ) , end of week 3 ( T2 ) and end of week 6 ( T3 ) . Lipid profile parameters were determined by enzymic methods . Results showed no significant difference in lipid profile within any group throughout the study . Comparing mean differences ( T1 - T3 ) among the three groups showed : no difference in TAG and LDL-cholesterol , a decrease in cholesterol in both conventional ( P probiotic yoghurt groups ( P total : HDL-cholesterol ratio for conventional ( P probiotic yoghurt groups ( P HDL-cholesterol in the probiotic yoghurt group ( P lipid profile were observed in both yoghurt groups . Any added effect , therefore , is due to the consumption of fermented milk products",
"To evaluate the effects of probiotic ( VSL#3 ) and omega-3 fatty acid on insulin sensitivity , blood lipids , and inflammation , we conducted a clinical trial in 60 overweight ( BMI > 25 ) , healthy adults , aged 40–60 years . After initial screening the subjects were r and omized into four groups with 15 per group . The four groups received , respectively , placebo , omega-3 fatty acid , probiotic VSL#3 , or both omega-3 and probiotic , for 6 weeks . Blood and fecal sample s were collected at baseline and after 6 weeks . The probiotic ( VSL#3 ) supplemented group had significant reduction in total cholesterol , triglyceride , LDL , and VLDL and had increased HDL ( P VSL#3 improved insulin sensitivity ( P decreased hsCRP , and favorably affected the composition of gut microbiota . Omega-3 had significant effect on insulin sensitivity and hsCRP but had no effect on gut microbiota . Addition of omega-3 fatty acid with VSL#3 had more pronounced effect on HDL , insulin sensitivity and hsCRP . Subjects with low HDL , insulin resistance , and high hsCRP had significantly lower total lactobacilli and bifidobacteria count and higher E. coli and bacteroides count ",
"This clinical trial aim ed to discover the effects of probiotic soy milk and soy milk on MLH1 and MSH2 promoter methylation , and oxidative stress among type II diabetic patients . Forty patients with type II diabetes mellitus aged 35–68 years were assigned to two groups in this r and omized , double-blind , controlled clinical trial . Patients in the intervention group consumed 200 ml/day of probiotic soy milk containing Lactobacillus plantarum A7 , while those in the control group consumed 200 ml/d of conventional soy milk for 8 weeks . Fasting blood sample s , anthropometric measurements , and 24-h dietary recalls were collected at the baseline and at the end of the study , respectively . Probiotic soy milk significantly decreased promoter methylation in proximal and distal MLH1 promoter region ( P while plasma concentration of 8-hydroxy-2′-deoxyguanosine ( 8-OHdG ) decreased significantly compared with soy milk ( P increase in superoxide dismutase ( SOD ) activity was observed in probiotic soy milk group compared with baseline value ( P changes from baseline in the promoter methylation of MSH2 within either group ( P > 0.05 ) . The consumption of probiotic soy milk improved antioxidant status in type II diabetic patients and may decrease promoter methylation among these patients , indicating that probiotic soy milk is a promising agent for diabetes management",
"Background Gut lactobacilli can affect the metabolic functions of healthy humans . We tested whether a 1500 kcal/d diet supplemented with cheese containing the probiotic Lactobacillus plantarum TENSIA ( Deutsche Sammlung für Mikroorganismen , DSM 21380 ) could reduce some symptoms of metabolic syndrome in Russian adults with obesity and hypertension . Methods In this 3-week , r and omized , double-blind , placebo-controlled , parallel pilot study , 25 subjects ingested probiotic cheese and 15 ingested control cheese . Fifty grams of each cheese provided 175 kcal of energy . Blood pressure ( BP ) , anthropometric characteristics , markers of liver and kidney function , metabolic indices ( plasma glucose , lipids , and cholesterol ) , and urine polyamines were measured . Counts of fecal lactobacilli and L. plantarum TENSIA were evaluated using molecular methods . The data were analyzed by t-test for independent sample s and Spearman ’s partial correlation analysis . Results The probiotic L. plantarum TENSIA was present in variable amounts ( 529.6 ± 232.5 gene copies ) in 16/25 ( 64 % ) study subjects . Body mass index ( BMI ) was significantly reduced ( p = 0.031 ) in the probiotic cheese group versus the control cheese group . The changes in BMI were closely associated with the water content of the body ( r = 0.570 , p = 0.0007 ) when adjusted for sex and age . Higher values of intestinal lactobacilli after probiotic cheese consumption were associated with higher BMI ( r = 0.383 , p = 0.0305 ) and urinary putrescine content ( r = 0.475 , p = 0.006 ) . In patients simultaneously treated with BP-lowering drugs , similar reductions of BP were observed in both groups . A positive association was detected between TENSIA colonization and the extent of change of morning diastolic BP ( r = 0.617 , p = 0.0248 ) and a trend toward lower values of morning systolic BP ( r = −0.527 , p = 0.0640 ) at the end of the study after adjusting for BMI , age , and sex . Conclusion In a pilot study of obese hypertensive patients , a hypocaloric diet supplemented with a probiotic cheese helps to reduce BMI and arterial BP values , recognized symptoms of metabolic syndrome . Trial registration Current Controlled Trials IS RCT",
"OBJECTIVE Oxidative stress plays a major role in the pathogenesis and progression of diabetes . Among various functional foods with an antioxidant effect , probiotic foods have been reported to repress oxidative stress . The objective of this clinical trial was to assess the effects of probiotic and conventional yogurt on blood glucose and antioxidant status in type 2 diabetic patients . METHODS Sixty-four patients with type 2 diabetes mellitus , 30 to 60 y old , were assigned to two groups in this r and omized , double-blind , controlled clinical trial . The patients in the intervention group consumed 300 g/d of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 and those in the control group consumed 300 g/d of conventional yogurt for 6 wk . Fasting blood sample s , 24-h dietary recalls , and anthropometric measurements were collected at the baseline and at the end of the trial . RESULTS Probiotic yogurt significantly decreased fasting blood glucose ( P hemoglobin A1c ( P erythrocyte superoxide dismutase and glutathione peroxidase activities and total antioxidant status ( P serum malondialdehyde concentration significantly decreased compared with the baseline value in both groups ( P insulin concentration and erythrocyte catalase activity within either group ( P > 0.05 ) . CONCLUSION The consumption of probiotic yogurt improved fasting blood glucose and antioxidant status in type 2 diabetic patients . These results suggest that probiotic yogurt is a promising agent for diabetes management",
"Background / Objectives : Evidence from animal and in vitro models suggest a role of probiotic bacteria in improving glycaemic control and delaying the onset of type 2 diabetes . However , the evidence from controlled trials in humans is limited . The objective was to determine if the probiotic bacteria L. acidophilus La5 and B. animalis subsp lactis Bb12 , supplemented in a whole food ( yoghurt ) or isolated ( capsules ) form , can improve biomarkers of glycaemic control . Subjects/ methods : Following a 3-week washout period , 156 overweight men and women over 55 years ( mean age : 67±8 years ; mean body mass index ( 31±4 kg/m2 ) were r and omized to a 6-week double-blinded parallel study . The four intervention groups were : ( A ) probiotic yoghurt plus probiotic capsules ; ( B ) probiotic yoghurt plus placebo capsules ; ( C ) control milk plus probiotic capsules ; and ( D ) control milk plus placebo capsules . Outcome measurements , including fasting glucose , insulin , glycated haemoglobin and Homoeostasis Model Assessment of Insulin Resistance ( HOMA-IR ) , were performed at baseline and week 6 . Results : Relative to the milk-control group , probiotic yoghurt result ed in a significantly higher HOMA-IR ( 0.32±0.15 , P=0.038 ) , but did not have a significant effect on the other three measures of glycaemic control ( P>0.05 ) . Relative to placebo capsules , probiotic capsules result ed in a significantly higher fasting glucose ( 0.15±0.07 mmol/l , P=0.037 ) , with no significant effect on the other three measures of glycaemic control ( P>0.05 ) . Further analyses did not identify other variables as contributing to these adverse findings . Conclusions : Data from this study does not support the hypothesis that L. acidophilus La5 and B. animalis subsp lactis Bb12 , either in isolated form or as part of a whole food , benefit short-term glycaemic control . Indeed , there is weak data for an adverse effect of these strains on glucose homoeostasis ",
"BACKGROUND Recent studies have reported beneficial effects of probiotics on maternal glycemia in healthy pregnant women . Obesity significantly increases risk of impaired glucose tolerance in pregnancy , but glycemic effects of probiotics in this specific obstetric group require additional investigation . OBJECTIVE The aim of the Probiotics in Pregnancy Study was to investigate the effect of a probiotic capsule on maternal fasting glucose in obese pregnant women . DESIGN In this placebo-controlled , double-blind , r and omized trial , 175 pregnant women with an early pregnancy body mass index ( BMI ; in kg/m² ) from 30.0 to 39.9 were recruited from antenatal clinics at the National Maternity Hospital , Dublin , Irel and . Exclusion criteria were BMI 39.9 , prepregnancy or gestational diabetes , age Women were r and omly assigned to receive either a daily probiotic or a placebo capsule from 24 to 28 wk of gestation in addition to routine antenatal care . The primary outcome was the change in fasting glucose between groups from preintervention to postintervention . Secondary outcomes were the incidence of gestational diabetes and neonatal anthropometric measures . RESULTS In 138 women who completed the study ( 63 women in the probiotic group ; 75 women in the placebo group ) , mean ( ±SD ) early pregnancy BMI was 33.6 ± 2.6 , which differed significantly between probiotic ( 32.9 ± 2.4 ) and placebo ( 34.1 ± 2.7 ) groups . With adjustment for BMI , the change in maternal fasting glucose did not differ significantly between treated and control groups [ -0.09 ± 0.27 compared with -0.07 ± 0.39 mmol/L ; P = 0.391 ; B = -0.05 ( 95 % CI : -0.17 , 0.07 ) ] . There were also no differences in the incidence of impaired glycemia ( 16 % in the probiotic group compared with 15 % in the placebo group ; P = 0.561 ) , birth weight ( 3.70 kg in the probiotic group compared with 3.68 kg in the placebo group ; P = 0.723 ) , or other metabolic variables or pregnancy outcomes . A secondary analysis of 110 women , excluding antibiotic users and poor compliers , also revealed no differences in maternal glucose or other outcomes between groups . CONCLUSION Probiotic treatment of 4 wk during pregnancy did not influence maternal fasting glucose , the metabolic profile , or pregnancy outcomes in obese women",
"A significant number of human clinical trials have reported no adverse effects associated with consumption of Lactobacillus reuteri ( L. reuteri ) . In the present study , the clinical safety and toxicology of oral ingestion of supplement capsules containing L. reuteri NCIMB 30242 was investigated . A r and omized group of 131 subjects received a dose of 2.9 × 10⁹ CFU L. reuteri NCIMB 30242 capsules ( n=67 ) or placebo capsules ( n=64 ) twice daily for 9 weeks . Clinical chemistry and hematological parameters of safety were analyzed . The frequency , duration and intensity of adverse events (AE)s and clinical significance of safety parameters were recorded for both groups . No clinical ly significant differences between the probiotic capsule and placebo capsule treated groups were detected in either the blood clinical chemistry or hematology results . The frequency and intensity of AEs was similar in the two groups . These results demonstrate that administration of a twice daily dose of 2.9 × 10⁹ CFU was safe and well tolerated in the population evaluated over 9 weeks",
"Summary The action of gliclazide , a sulphonylurea with beneficial extrapancreatic effects in diabetes , may be enhanced by administering probiotics . The aim of this study was to investigate the influence of probiotics on gliclazide pharmacokinetics and the effect of both probiotics and gliclazide on blood glucose levels in healthy and diabetic rats . Male Wistar rats ( 2 to 3 months , weight 350 ± 50 g ) were r and omly allocated to 4 groups ( n = 10 ) , two of which were treated with alloxan i.v . 30 mg/kg to induce diabetes . One group of healthy and one group of diabetic rats were then gavaged with probiotics ( 75 mg/kg ) for three days after which a gliclazide suspension ( 20 mg/kg ) was administered by gavage to all groups . Blood sample s were collected from the tail vein at various time points for 10 hours post-administration for the determination of blood glucose and gliclazide serum concentrations . It was found that probiotic treatment had no effect on blood glucose levels in healthy rats , but it reduced them ( up to 2-fold;p reduced gliclazide bioavailability in healthy rats ( 3-fold ) whereas it increased gliclazide bioavailability in diabetic rats ( 2-fold;p ) . Gliclazide had no effect on blood glucose levels in either healthy or diabetic rats despite the changes in its bioavailability . In conclusion , the probiotic treatment of diabetic rats increases gliclazide bioavailability and lowers blood glucose levels by insulin-independent mechanisms , suggesting that the administration of probiotics may be beneficial as adjunct therapy in the treatment of diabetes",
"Background : Control of blood sugar , hypertension , and dyslipidemia are key factors in diabetes management . Cucurbita ficifolia ( pumpkin ) is a vegetable which has been used traditionally as a remedy for diabetes in Iran . In addition , consumption of probiotics may have beneficial effects on people with Type 2 diabetes . The aim of this study was an investigation of the effects of C. ficifolia and probiotic yogurt consumption alone or at the same time on blood glucose and serum lipids in diabetic patients . Methods : Eighty eligible participants r and omly were assigned to four groups : 1 - green C. ficifolia ( 100 g ) ; 2 - probiotic yogurt ( 150 g ) ; 3 - C. ficifolia plus probiotic yogurt ( 100 g C. ficifolia plus 150 g yogurt ) ; and 4 -control ( dietary advice ) for 8 weeks . Blood pressure , glycemic response , lipid profile , and high-sensitive C-reactive protein ( hsCRP ) were measured before and after the intervention . Results : Total cholesterol ( TC ) decreased significantly in yogurt and yogurt plus C. ficifolia groups ( within groups P = 0.010 , and P C. ficifolia plus yogurt consumption result ed in a decrease in triglyceride ( TG ) and an increase in high-density lipoprotein cholesterol ( HDL-C ) ( within groups P blood sugar , hemoglobin A1c ( HbA1c ) , hsCRP , and low-density lipoprotein cholesterol ( LDL-C ) level within groups . Blood pressure decreased significantly in Cucurbita group and yogurt group ( within groups P systolic blood pressure [ SBP ] and P diastolic blood pressure [ DBP ] , respectively ) . All variables changed between groups significantly except LDL-C level . Conclusions : Variables including TG , HDL-C , TC , fasting blood sugar , HbA1c , SBP , DBP , and hsCRP changed beneficially between groups . It seems that consumption of C. ficifolia and probiotic yogurt may help treatment of diabetic patients",
"The purpose of this study was to investigate the effects of probiotic and conventional yogurt on the lipid profile in type 2 diabetic people . In a r and omized double-blind controlled trial , 60 people ( 23 males and 37 females ) with type 2 diabetes and low-density lipoprotein cholesterol ( LDL-C ) greater than 2.6 mmol/L were assigned to 2 groups . Participants consumed daily 300 g of probiotic yogurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 or 300 g of conventional yogurt for 6 wk . Fasting blood sample s , anthropometric measurements and 3-d , 24-h dietary recalls were collected at the baseline and at the end of the trial . Probiotic yogurt consumption caused a 4.54 % decrease in total cholesterol and a 7.45 % decrease in LDL-C compared with the control group . No significant changes from baseline were shown in triglyceride and high-density lipoprotein cholesterol ( HDL-C ) in the probiotic group . The total cholesterol : HDL-C ratio and LDL-C : HDL-C ratio as atherogenic indices significantly decreased in the probiotic group compared with the control group . Probiotic yogurt improved total cholesterol and LDL-C concentrations in type 2 diabetic people and may contribute to the improvement of cardiovascular disease risk factors"
] | 41163800-06ff-11f0-808a-c43d1ab1c353 |
A preoperative surgical risk analysis is necessary and important for predicting clinical and surgical outcomes in a clinical setting . Various tools for evaluating the patient characteristics in order to forecast perioperative clinical outcomes have previously been described ; however , an objective and precise preoperative risk assessment has not yet been established . In the last decade , the concept of frailty , which is a geriatric assessment that identifies disabilities and weaknesses in patients , has been used in order to predict clinical mortality and morbidity following invasive surgical interventions because the prevalence of elderly patients among those undergoing surgical interventions is increasing . Since there is currently no single generally accepted clinical definition of frailty , many clinical modalities are needed to evaluate the patients ’ geriatric activity of daily living . Quantifying the quality of frailty is an evolving challenge for predicting surgical risks preoperatively . In recent years , with the development of transcatheter aortic valve implantation ( TAVI ) , this newly definitive preoperative surgical risk assessment tool , frailty , has become more important and is attracting interest in cardiothoracic surgical setting s. Thus , this review summarized current consideration on the preoperative risk analysis by frailty as well as future perspectives and the potential of an ideal frailty risk assessment in cardiothoracic surgery , including the management of elderly patients and high-risk aortic valve stenosis by TAVI | [
"Background — Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery . Where elderly patients are increasingly referred for cardiac surgery , the prevalence of a frail group among these is also on the rise . We assessed frailty as a risk factor for adverse outcomes after cardiac surgery . Methods and Results — Functional measures of frailty and clinical data were collected prospect ively for all cardiac surgery patients at a single center . Frailty was defined as any impairment in activities of daily living ( Katz index ) , ambulation , or a documented history of dementia . Of 3826 patients , 157 ( 4.1 % ) were frail . Frail patients were older , were more likely to be female , and had risk factors for adverse surgical outcomes . By logistic regression , frailty was an independent predictor of in-hospital mortality ( odds ratio 1.8 , 95 % CI 1.1 to 3.0 ) , as well as institutional discharge ( odds ratio 6.3 , 95 % CI 4.2 to 9.4 ) . Frailty was an independent predictor of reduced midterm survival ( hazard ratio 1.5 , 95 % CI 1.1 to 2.2 ) . Conclusions — Frailty is a risk for postoperative complications and an independent predictor of in-hospital mortality , institutional discharge , and reduced midterm survival . Frailty screening improves risk assessment in cardiac surgery patients and may identify a subgroup of patients who may benefit from innovative processes of care",
"OBJECTIVES The purpose of this study was to test the value of gait speed , a clinical marker for frailty , to improve the prediction of mortality and major morbidity in elderly patients undergoing cardiac surgery . BACKGROUND It is increasingly difficult to predict the elderly patient 's risk posed by cardiac surgery because existing risk assessment tools are incomplete . METHODS A multicenter prospect i ve cohort of elderly patients undergoing cardiac surgery was assembled at 4 tertiary care hospitals between 2008 and 2009 . Patients were eligible if they were 70 years of age or older and were scheduled for coronary artery bypass and /or valve replacement or repair . The primary predictor was slow gait speed , defined as a time taken to walk 5 m of ≥ 6 s. The primary end point was a composite of in-hospital post-operative mortality or major morbidity . RESULTS The cohort consisted of 131 patients with a mean age of 75.8 ± 4.4 years ; 34 % were female patients . Sixty patients ( 46 % ) were classified as slow walkers before cardiac surgery . Slow walkers were more likely to be female ( 43 % vs. 25 % , p = 0.03 ) and diabetic ( 50 % vs. 28 % , p = 0.01 ) . Thirty patients ( 23 % ) experienced the primary composite end point of mortality or major morbidity after cardiac surgery . Slow gait speed was an independent predictor of the composite end point after adjusting for the Society of Thoracic Surgeons risk score ( odds ratio : 3.05 ; 95 % confidence interval : 1.23 to 7.54 ) . CONCLUSIONS Gait speed is a simple and effective test that may identify a subset of vulnerable elderly patients at incrementally higher risk of mortality and major morbidity after cardiac surgery",
"Background : There is no single generally accepted clinical definition of frailty . Previously developed tools to assess frailty that have been shown to be predictive of death or need for entry into an institutional facility have not gained acceptance among practising clinicians . We aim ed to develop a tool that would be both predictive and easy to use . Methods : We developed the 7-point Clinical Frailty Scale and applied it and other established tools that measure frailty to 2305 elderly patients who participated in the second stage of the Canadian Study of Health and Aging ( CSHA ) . We followed this cohort prospect ively ; after 5 years , we determined the ability of the Clinical Frailty Scale to predict death or need for institutional care , and correlated the results with those obtained from other established tools . Results : The CSHA Clinical Frailty Scale was highly correlated ( r = 0.80 ) with the Frailty Index . Each 1-category increment of our scale significantly increased the medium-term risks of death ( 21.2 % within about 70 mo , 95 % confidence interval [ CI ] 12.5%–30.6 % ) and entry into an institution ( 23.9 % , 95 % CI 8.8%–41.2 % ) in multivariable models that adjusted for age , sex and education . Analyses of receiver operating characteristic curves showed that our Clinical Frailty Scale performed better than measures of cognition , function or comorbidity in assessing risk for death ( area under the curve 0.77 for 18-month and 0.70 for 70-month mortality ) . Interpretation : Frailty is a valid and clinical ly important construct that is recognizable by physicians . Clinical judgments about frailty can yield useful predictive information",
"Background — Cardiac surgery risk scores perform poorly in elderly patients , in part because they do not take into account frailty and disability which are critical determinants of health status with advanced age . There is an unmet need to combine established cardiac surgery risk scores with measures of frailty and disability to provide a more complete model for risk prediction in elderly patients undergoing cardiac surgery . Methods and Results — This was a prospect i ve , multicenter cohort study of elderly patients ( ≥70 years ) undergoing coronary artery bypass and /or valve surgery in the United States and Canada . Four different frailty scales , 3 disability scales , and 5 cardiac surgery risk scores were measured in all patients . The primary outcome was the STS composite end point of in-hospital postoperative mortality or major morbidity . A total of 152 patients were enrolled , with a mean age of 75.9±4.4 years and 34 % women . Depending on the scale used , 20–46 % of patients were found to be frail , and 5–76 % were found to have at least 1 disability . The most predictive scale in each domain was : 5-meter gait speed ≥6 seconds as a measure of frailty ( odds ratio [ OR ] , 2.63 ; 95 % confidence interval [ CI ] , 1.17–5.90 ) , ≥3 impairments in the Nagi scale as a measure of disability ( OR , 2.98 ; 95 % CI , 1.35–6.56 ) and either the Parsonnet score ( OR , 1.08 ; 95 % CI , 1.04–1.13 ) or Society of Thoracic Surgeons Predicted Risk of Mortality or Major Morbidity ( STS-PROMM ) ( OR , 1.05 ; 95 % CI , 1.01–1.09 ) as a cardiac surgery risk score . Compared with the Parsonnet score or STS-PROMM alone , ( area under the curve , 0.68–0.72 ) , addition of frailty and disability provided incremental value and improved model discrimination ( area under the curve , 0.73–0.76 ) . Conclusions — Clinicians should use an integrative approach combining frailty , disability , and risk scores to better characterize elderly patients referred for cardiac surgery and identify those that are at increased risk",
"Aims This study aim ed to assess functional course in elderly patients undergoing transcatheter aortic valve implantation ( TAVI ) and to find predictors of functional decline . Methods and results In this prospect i ve cohort , functional course was assessed in patients ≥70 years using basic activities of daily living ( BADL ) before and 6 months after TAVI . Baseline EuroSCORE , STS score , and a frailty index ( based on assessment of cognition , mobility , nutrition , instrumental and basic activities of daily living ) were evaluated to predict functional decline ( deterioration in BADL ) using logistic regression models . Functional decline was observed in 22 ( 20.8 % ) of 106 surviving patients . EuroSCORE ( OR per 10 % increase 1.18 , 95 % CI : 0.83 - 1.68 , P = 0.35 ) and STS score ( OR per 5 % increase 1.64 , 95 % CI : 0.87 - 3.09 , P = 0.13 ) weakly predicted functional decline . In contrast , the frailty index strongly predicted functional decline in univariable ( OR per 1 point increase 1.57 , 95 % CI : 1.20 - 2.05 , P = 0.001 ) and bivariable analyses ( OR : 1.56 , 95 % CI : 1.20 - 2.04 , P = 0.001 controlled for EuroSCORE ; OR : 1.53 , 95 % CI : 1.17 - 2.02 , P = 0.002 controlled for STS score ) . Overall predictive performance was best for the frailty index [ Nagelkerke 's R(2 ) ( NR(2 ) ) 0.135 ] and low for the EuroSCORE ( NR(2 ) 0.015 ) and STS score ( NR(2 ) 0.034 ) . In univariable analyses , all components of the frailty index contributed to the prediction of functional decline . Conclusion Over a 6-month period , functional status worsened only in a minority of patients surviving TAVI . The frailty index , but not established risk scores , was predictive of functional decline . Refinement of this index might help to identify patients who potentially benefit from additional geriatric interventions after TAVI ",
"OBJECTIVES This study sought to evaluate the impact of frailty in older adults undergoing transcatheter aortic valve replacement ( TAVR ) for symptomatic aortic stenosis . BACKGROUND Frailty status impacts prognosis in older adults with heart disease ; however , the impact of frailty on prognosis after TAVR is unknown . METHODS Gait speed , grip strength , serum albumin , and activities of daily living status were collected at baseline and used to derive a frailty score among patients who underwent TAVR procedures at a single large-volume institution . The cohort was dichotomized on the basis of median frailty score into frail and not frail groups . The impact of frailty on procedural outcomes ( stroke , bleeding , vascular complications , acute kidney injury , and mortality at 30 days ) and 1-year mortality was evaluated . RESULTS Frailty status was assessed in 159 subjects who underwent TAVR ( age 86 ± 8 years , Society of Thoracic Surgery Risk Score 12 ± 4 ) . Baseline frailty score was not associated with conventionally ascertained clinical variables or Society of Thoracic Surgery score . Although high frailty score was associated with a longer post-TAVR hospital stay when compared with lower frailty score ( 9 ± 6 days vs. 6 ± 5 days , respectively , p = 0.004 ) , there were no significant crude associations between frailty status and procedural outcomes , suggesting adequacy of the st and ard selection process for identifying patients at risk for periprocedural complications after TAVR . Frailty status was independently associated with increased 1-year mortality ( hazard ratio : 3.5 , 95 % confidence interval : 1.4 to 8.5 , p = 0.007 ) after TAVR . CONCLUSIONS Frailty was not associated with increased periprocedural complications in patients selected as c and i date s to undergo TAVR but was associated with increased 1-year mortality after TAVR . Further studies will evaluate the independent value of this frailty composite in older adults with aortic stenosis",
"BACKGROUND The prevalence of comorbidities and functional impairment among elderly patients may enhance the risk of operation-related complications , but the importance of these conditions in elderly patients undergoing thoracic surgery remains unclear . METHODS One hundred twenty patients > /= 60 years of age who underwent thoracic surgery were registered prospect ively and examined . A comprehensive geriatric assessment ( CGA ) that evaluated such diverse areas as functional status ( ie , performance status and activities of daily living [ ADLs ] using the Barthel index ) , comorbidity , nutrition ( ie , body mass index , arm-muscle circumference , albumin level , transferrin level , lymphocyte count , and cholinesterase level ) , and cognitive function ( ie , mini-mental state examination [ MMSE ] and negative emotions for operation ) was performed in the 2 weeks before patients underwent the operation . RESULTS The diseases of the 120 patients were as follows : lung cancer , 85 patients ; mediastinal tumor , 14 patients ; bullas , 12 patients ; and other diseases , 9 patients . Postoperative complications developed in 20 patients ( 16.7 % ) . The patients with dependence for performing the ADLs , and dementia were more likely to develop postoperative complications ( p = 0.041 , and p = 0.0065 , respectively ) . The patients who experienced longer operation times ( ie , > /= 300 min ; p = 0.018 ) were more likely to have complications . The incidence of prolonged air leak in the patients with malnutrition increased seven-fold ( p = 0.045 ) and that of postoperative infectious diseases in those patients with obesity increased 24-fold ( p = 0.0013 ) , while all patients who developed delirium had low scores in the MMSE preoperatively ( p = 0.0003 ) . Using multiple logistic regression , the best model was obtained with a combination of MMSE ( p = 0.031 ) and the Barthel index ( p = 0.04 ) . When the operation variables were added to this model , the operation time had the strongest effect ( p = 0.016 ) . CONCLUSIONS Dependence for the performance of ADLs and impaired cognitive conditions are important predictors of postoperative complications , especially when the operation time is long . CGA is necessary in addition to the conventional cardiopulmonary functional assessment in elderly patients",
"BACKGROUND Physicians are only moderately accurate in estimating surgical risk based on clinical vignettes . We assessed the impact of perceived frailty by measuring the influence of a short video of a st and ardized patient on surgical risk estimates . METHODS Thoracic surgeons and cardiothoracic trainees estimated the risk of major complications for lobectomy based on clinical vignettes of varied risk categories ( low , average , high ) . After each vignette , subjects viewed a r and omly selected video of a st and ardized patient exhibiting either vigorous or frail behavior , then reestimated risk . Subjects were asked to rate 5 vignettes paired with 5 different st and ardized patients . RESULTS Seventy-one physicians participated . Initial risk estimates varied according to the vignette risk category : low 15.2%±11.2 % risk ; average 23.7%±16.1 % ; high 37.3%±18.9 % ( p influenced risk estimates more substantially ( high risk vignette , vigorous video 21.2%±23.5 % decrease in second risk estimate , p<0.001 ; low risk vignette , frail video 151.9%±209.8 % increase , p<0.001 ) . CONCLUSIONS Surgeons differentiated relative risk of lobectomy based on clinical vignettes . The effect of viewing videos was small when vignettes and videos were concordant ; the effect was more substantial when vignettes and videos were discordant . The information will be helpful in training future surgeons in frailty recognition and risk estimation",
"OBJECTIVES This study evaluated Multidimensional Geriatric Assessment ( MGA ) as predictor of mortality and major adverse cardiovascular and cerebral events ( MACCE ) after transcatheter aortic valve implantation ( TAVI ) . BACKGROUND Currently used global risk scores do not reliably estimate mortality and MACCE in these patients . METHODS This prospect i ve cohort comprised 100 consecutive patients ≥ 70 years undergoing TAVI . Global risk scores ( Society of Thoracic Surgeons [ STS ] score , EuroSCORE ) and MGA-based scores ( cognition , nutrition , mobility , activities of daily living [ ADL ] , and frailty index ) were evaluated as predictors of all-cause mortality and MACCE 30 days and 1 year after TAVI in regression models . RESULTS In univariable analyses , all predictors were significantly associated with mortality and MACCE at 30 days and 1 year , except for the EuroSCORE at 30 days and instrumental ADL at 30 days and 1 year . Associations of cognitive impairment ( odds ratio [ OR ] : 2.98 , 95 % confidence interval [ CI ] : 1.07 to 8.31 ) , malnutrition ( OR : 6.72 , 95 % CI : 2.04 to 22.17 ) , mobility impairment ( OR : 6.65 , 95 % CI : 2.15 to 20.52 ) , limitations in basic ADL ( OR : 3.63 , 95 % CI : 1.29 to 10.23 ) , and frailty index ( OR : 3.68 , 95 % CI : 1.21 to 11.19 ) with 1-year mortality were similar compared with STS score ( OR : 5.47 , 95 % CI : 1.48 to 20.22 ) and EuroSCORE ( OR : 4.02 , 95 % CI : 0.86 to 18.70 ) . Similar results were found for 30-day mortality and MACCE . Bivariable analyses , including STS score or EuroSCORE suggested independent associations of MGA-based scores ( e.g. , OR of frailty index : 3.29 , 95 % CI : 1.06 to 10.15 , for 1-year mortality in a model including EuroSCORE ) . CONCLUSIONS This study provides evidence that risk prediction can be improved by adding MGA-based information to global risk scores . Larger studies are needed for the development and validation of improved risk prediction models",
"Aims : The authors investigated the additive prognostic value of the 6-minute walk test ( 6MWT ) to Euroscore in patients with severe aortic stenosis undergoing aortic valve replacement ( AVR ) Methods and results : 208 patients with severe AS underwent the 6MWT before AVR , as part of a r and omised trial ( ASSERT ) comparing stented and stentless aortic valves . Clinical follow-up was available for 200 patients up to 12 months . The rate of death , myocardial infa rct ion ( MI ) or stroke ( time to first event ) was 13 % ( n = 14 ) in patients walking rate of death , MI or stroke by Euroscore risk was stratified by 6-minute walking distance , the 6MWT added prognostic information . In a Cox regression analysis 6MWT distance was the only variable retained as an independent predictor of the composite outcome of death , MI or stroke at 12 months ( HR 0.28 95 % CI 0.09 to 0.85 , p = 0.025 ) . Conclusions : The 6MWT is safe and feasible to carry out in patients with severe aortic stenosis before AVR , and provides potentially important functional and prognostic information to clinical assessment and the Euroscore risk score"
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OBJECTIVE The objective of this review was to systematic ally analyze the trials on the effectiveness of perioperative warming in surgical patients . METHODS A systematic review of the literature was undertaken . Clinical trials on perioperative warming were selected according to specific criteria and analyzed to generate summative data expressed as st and ardized mean difference ( SMD ) . RESULTS Twenty-five studies encompassing 3,599 patients in various surgical disciplines were retrieved from the electronic data bases . Nineteen r and omized trials on 1785 patients qualified for this review . The no-warming group developed statistically significant hypothermia . In the fixed effect model , the warming group had significantly less pain and lower incidence of wound infection , compared with the no-warming group . In the r and om effect model , the warming group was also associated with lower risk of post-anesthetic shivering . Both in the r and om and the fixed effect models , the warming group was associated with significantly less blood loss . However , there was significant heterogeneity among the trials . CONCLUSION Perioperative warming of surgical patients is effective in reducing postoperative wound pain , wound infection and shivering . Systemic warming of the surgical patient is also associated with less perioperative blood loss through preventing hypothermia-induced coagulopathy . Perioperative warming may be given routinely to all patients of various surgical disciplines in order to counteract the consequences of hypothermia | [
"BACKGROUND Mild perioperative hypothermia , which is common during major surgery , may promote surgical-wound infection by triggering thermoregulatory vasoconstriction , which decreases subcutaneous oxygen tension . Reduced levels of oxygen in tissue impair oxidative killing by neutrophils and decrease the strength of the healing wound by reducing the deposition of collagen . Hypothermia also directly impairs immune function . We tested the hypothesis that hypothermia both increases susceptibility to surgical-wound infection and lengthens hospitalization . METHODS Two hundred patients undergoing colorectal surgery were r and omly assigned to routine intraoperative thermal care ( the hypothermia group ) or additional warming ( the normothermia group ) . The patient 's anesthetic care was st and ardized , and they were all given cefam and ole and metronidazole . In a double-blind protocol , their wounds were evaluated daily until discharge from the hospital and in the clinic after two weeks ; wounds containing culture-positive pus were considered infected . The patients ' surgeons remained unaware of the patients ' group assignments . RESULTS The mean ( + /- SD ) final intraoperative core temperature was 34.7 + /- 0.6 degrees C in the hypothermia group and 36.6 + /- 0.5 degrees C in the normothermia group ( P Surgical-wound infections were found in 18 of 96 patients assigned to hypothermia ( 19 percent ) but in only 6 of 104 patients assigned to normothermia ( 6 percent , P = 0.009 ) . The sutures were removed one day later in the patients assigned to hypothermia than in those assigned to normothermia ( P = 0.002 ) , and the duration of hospitalization was prolonged by 2.6 days ( approximately 20 percent ) in hypothermia group ( P = 0.01 ) . CONCLUSIONS Hypothermia itself may delay healing and predispose patients to wound infections . Maintaining normothermia intraoperatively is likely to decrease the incidence of infectious complications in patients undergoing colorectal resection and to shorten their hospitalizations",
"BACKGROUND In-vitro studies indicate that platelet function and the coagulation cascade are impaired by hypothermia . However , the extent to which perioperative hypothermia influences bleeding during surgery remains unknown . Accordingly , we tested the hypothesis that mild hypothermia increases blood loss and allogeneic transfusion requirements during hip arthroplasty . METHODS Blood loss and transfusion requirements were evaluated in 60 patients undergoing primary , unilateral total hip arthroplasties who were r and omly assigned to normothermia ( final intraoperative core temperature 36.6 [ 0.4 ] degrees C ) or mild hypothermia ( 35.0 [ 0.5 ] degrees C ) . Crystalloid , colloid , scavenged red cells , and allogeneic blood were administered by strict protocol . FINDINGS Intra- and postoperative blood loss was significantly greater in the hypothermic patients : 2.2 ( 0.5 ) L vs 1.7 ( 0.3 ) L , p allogeneic packed red cells were required in seven of the 30 hypothermic patients , whereas only one normothermic patient required a unit of allogeneic blood ( p core temperature in patients undergoing hip arthroplasty will thus augment blood loss by approximately 500 mL. INTERPRETATION The maintenance of intraoperative normothermia reduces blood loss and allogeneic blood requirements in patients undergoing total hip arthroplasty",
"Postoperative hypothermia is common and associated with adverse hemodynamic consequences , including adrenergically mediated systemic vasoconstriction and hypertension . Hypothermia is also a known predictor of dysrhythmias and myocardial ischemia in high-risk patients . We describe a prospect i ve , r and omized trial design ed to test the hypothesis that forced-air warming ( FAW ) provides improved hemodynamic variables after coronary artery bypass graft . After institutional review board approval and written informed consent , 149 patients undergoing coronary artery bypass graft were r and omized to receive postoperative warming with either FAW ( n = 81 ) or a circulating water mattress ( n = 68 ) . Core temperature was measured at the tympanic membrane . A weighted mean skin temperature was calculated . Heart rate , mean arterial blood pressure , central venous pressure , cardiac output , and systemic vascular resistance were monitored for 22 h postoperatively . Mean arterial blood pressure was maintained by protocol between 70 and 80 mm Hg by titration of nitroglycerin and sodium nitroprusside . The two groups had similar demographic characteristics . Tympanic and mean skin temperatures were similar between groups on intensive care unit admission . During postoperative rewarming , tympanic temperature was similar between groups , but mean skin temperature was significantly greater in the FAW group ( P Heart rate , mean arterial pressure , central venous pressure , cardiac output , and systemic vascular resistance were similar for the two groups . The percent of patients requiring nitroprusside to achieve the hemodynamic goals was less ( P mean skin temperature and a decreased requirement for vasodilator therapy in hypothermic patients after cardiac surgery . This most likely reflects attenuation of the adrenergic response or opening of cutaneous vascular beds as a result of surface warming . Implication s Forced-air warming after cardiac surgery decreases the requirement for vasodilator drugs and may be beneficial in maintaining hemodynamic variables within predefined limits",
"BACKGROUND Even mild perioperative hypothermia is associated with several severe adverse effects . Resistive heating has possible advantages compared with other active warming systems because it can heat several fields independently . To assess this new warming system , we measured core temperature in patients during surgery who were warmed with circulating water mattresses , forced air covers or resistive heating covers . METHODS Twenty-four patients undergoing laparoscopic cholecystectomy were r and omly assigned to ( i ) circulating water mattress ( 38 degrees C ) , ( ii ) forced air warming ( set to ' medium ' ) or ( iii ) carbon-fibre resistive warming ( 38 degrees C ) . Warming was applied throughout anaesthesia and surgery . The groups were compared using one-way ANOVA and Student-Newman-Keuls tests . RESULTS Confounding factors were similar among the groups . Core temperatures in each group decreased for 20 min , but subsequently increased in the forced air and resistive heating groups . There was no significant difference between the forced air and resistive heating groups at any time . In contrast , core temperature in the circulating water group continued to decrease . Consequently , core temperature in the circulating water group was significantly lower than in the other groups 30 min after anaesthetic induction and at later times . CONCLUSIONS Resistive heating maintains core body temperature as well as forced air heating and both are better than circulating water . Resistive heating offers the advantage of adjustable heating pods",
"OBJECTIVE To investigate the influence of using fluid warming and forced-air warming system on patient core temperature , blood loss , blood transfusion , extubation time , and postoperative shivering . METHODS Forty ASA ( American Society of Anesthesiologists ' Physical Status ) I-II patients , aged 21 - 69 years , scheduled for elective abdominal surgery under general anesthesia , were enrolled in the study . The patients were premedicated with intramuscular dolantin 50 mg and atropine 0.5 mg . Anesthesia was induced with midazolam 1 mg , fentanyl 50 - 100 microg and propofol 1.5 - 2.0 mg/kg . Tracheal intubation was facilitated with vecuronium 1 mg and succinylcholine 1.5 - 2.0 mg/kg . The patients were mechanically ventilated and anesthesia was maintained with isoflurane 1.5 - 2.0 % , 50 % N2O in oxygen and intermittent iv boluses of fentanyl ( total dose 5 - 6 microg/kg ) . Vecuronium was used for muscle relaxation during maintenance of anesthesia . The patients were r and omly divided into 2 groups : control group ( n = 20 ) and warming group ( n = 20 ) . In both groups , the patients were covered with surgery blanket . In the warming group , patients were additionally warmed with fluid warming device and forced-air warming system during the operation . The core temperature was recorded every 20 minutes during the operation , as well as the blood loss , blood transfusion , extubation time and postoperative shivering . RESULTS The core temperature at the end of the surgery was ( 36.4 + /- 0.4 ) degrees C in the warming group and ( 35.3 + /- 0.5 ) degrees C in the control group . The difference was statistically significant ( t = 7.547 , P blood loss and blood transfusion between two groups . The extubation time was significantly shorter in the warming group [ ( 18 + /- 6 ) vs ( 26 + /- 10 ) min , t = -3.364 , P = 0.002 ] . 6 patients shivered postoperatively in the control group and none in the warming group ( chi2 = 7.059 , P = 0.008 ) . CONCLUSION Fluid warming system and forced-air warming system can effectively maintain normothermia during the surgery and then help to reduce the extubation time and postoperative shivering",
"OBJECTIVE To evaluate the effect of intraoperative combined forced-air warming and fluid warming system on patient 's core temperature , blood loss , transfusion dem and , extubation time , and incidence of postoperative shivering . METHODS Forty patients with American Society of Anesthesiologists physical status I and II , aged 18 - 70 years , scheduled for elective abdominal surgery were r and omly assigned to receive intraoperative warming from a forced-air blanket and fluid warming system or conventional cotton blanket , 20 in each group . The core temperature was recorded every 20 minutes during the operation , as well as the blood loss , blood transfusion , extubation time , and incidence of postoperative shivering . RESULTS The core temperature at the end of the surgery in the warming group was significantly different from that in the control group ( 36.4 + /- 0.4 degrees C vs. 35.3 + /- 0.5 degrees C , P time between the end of the surgery and extubation ( P Postoperative shivering occurred in 30 % of the patients in the control group compared to no patient in the warming group ( P warming with air-forced blanket and fluid warming system provides sufficient heat to prevent hypothermia during abdominal surgery",
"BACKGROUND We hypothesized that normothermic cardiopulmonary bypass ( CPB ) would be associated with decreased blood loss and allogeneic transfusion requirements relative to hypothermic CPB . METHODS After obtaining institutional review board approval and informed patient consent , we conducted a prospect i ve , r and omized study of 79 patients undergoing CPB for a primary cardiac operation at normothermic ( 37 degrees C ) ( n = 44 ) or hypothermic temperature ( 25 degrees C ) ( n = 35 ) . Blood loss and transfusion requirements in the operating room and for the first 24 hours in the intensive care unit were determined . A paired t test and rank sum tests were used . A p value of less than 0.05 was considered significant . RESULTS The normothermic and hypothermic CPB groups did not differ in demographic variables , CPB or cross-clamp duration , heparin sodium or protamine sulfate dose , prothrombin time , or thromboelastogram results . There were no differences between the two CPB groups in blood loss or transfusion requirements . CONCLUSIONS We found that when there was no difference in duration of CPB , normothermic and hypothermic CPB groups demonstrated similar blood loss and transfusion requirements even though other studies have shown hypothermia induces platelet dysfunction and alters the activity of the coagulation cascade",
"STUDY OBJECTIVES To evaluate the effects of intraoperative skin-surface warming with and without 1 hour of preoperative warming , in preventing intraoperative hypothermia , and postoperative hypothermia , and shivering , and in offering good conditions to early tracheal extubation . DESIGN Prospect i ve , r and omized , blind study . SETTING Teaching hospital . PATIENTS 30 ASA physical status I and II female patients scheduled for elective abdominal surgery . INTERVENTIONS Patients received st and ard general anesthesia . In 10 patients , no special pre caution s were taken to avoid hypothermia . Ten patients were su bmi tted to preoperative and intraoperative active warming . Ten patients were only warmed intraoperatively . MEASUREMENTS AND MAIN RESULTS Temperatures were recorded at 15-minute intervals . The patients who were warmed preoperatively and intraoperatively had core temperatures significantly more elevated than the other patients during the first two hours of anesthesia . All patients warmed intraoperatively were normothermic only at the end of the surgery . The majority of the patients warmed preoperatively and intraoperatively or intraoperatively only were extubated early , and none had shivering . In contrast , five unwarmed patients shivered . CONCLUSIONS One hour of preoperative warning combined with intraoperative skin-surface warming , not simply intraoperative warming alone , avoided hypothermia caused by general anesthesia during the first two hours of surgery . Both methods prevented postoperative hypothermia and shivering and offered good conditions for early tracheal extubation",
"We evaluated the effects of aggressive warming and maintenance of normothermia on surgical blood loss and allogeneic transfusion requirement . We r and omly assigned 150 patients undergoing total hip arthroplasty with spinal anesthesia to aggressive warming ( to maintain a tympanic membrane temperature of 36.5 ° C ) or conventional warming ( 36 ° C ) . Autologous and allogeneic blood were given to maintain a priori design ated hematocrits . Blood loss was determined by a blinded investigator based on sponge weight and scavenged cells ; postoperative loss was determined from drain output . Results were analyzed on an intention-to-treat basis . Average intraoperative core temperatures were warmer in the patients assigned to aggressive warming ( 36.5 ° ± 0.3 ° vs 36.1 ° ± 0.3 ° C , P 0.001 ) . Mean arterial pressure was similar in each group preoperatively , but was greater intraoperatively in the conventionally warmed patients : 86 ± 12 vs 80 ± 9 mm Hg , P . Intraoperative blood loss was significantly greater in the conventional warming ( 618 mL ; interquartile range , 480–864 mL ) than the aggressive warming group ( 488 mL ; interquartile range , 368–721 mL;P = 0.002 ) , whereas postoperative blood loss did not differ in the two groups . Total blood loss during surgery and over the first two postoperative days was also significantly greater in the conventional warming group ( 1678 mL ; interquartile range , 1366–1965 mL ) than in the aggressively warmed group ( 1,531 mL ; interquartile range , 1055–1746 mL , P = 0.031 ) . A total of 40 conventionally warmed patients required 86 units of allogeneic red blood cells , whereas 29 aggressively warmed patients required 62 units ( P = 0.051 and 0.061 , respectively ) . We conclude that aggressive intraoperative warming reduces blood loss during hip arthroplasty . Implication s Aggressive warming better maintained core temperature ( 36.5 ° vs 36.1 ° C ) and slightly decreased intraoperative blood pressure . Aggressive warming also decreased blood loss by approximately 200 mL. Aggressive warming may thus , be beneficial in patients undergoing hip arthroplasty",
"BACKGROUND The aim of this prospect i ve r and omized trial was to evaluate the efficacy of 3 intraoperative warming systems ( Warm-Touch , Thermamed SmartCare OP system , and Allon 2001 ) on maintenance of normothermia and to investigate their effects on perioperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass grafting . METHODS With institutional approval/patient informed consent , 90 patients presenting for elective multiple off-pump coronary artery bypass grafting were r and omly assigned to 1 of the 3 warming systems . Active warming was started after the induction of anesthesia . Perioperative transfusion was based on international guidelines . Body core temperature was recorded every 30 minutes during operation . Perioperative blood loss , autotransfusion , and allogenic transfusions were recorded . Analysis of variance was performed with post hoc Scheffé tests and chi 2 tests . RESULTS Normothermia could be sufficiently maintained during operation by the Allon 2001 only . Final body core temperature was 34.7 degrees C + /- 0.9 degrees C ( Warm-Touch ) , 35.6 degrees C + /- 0.8 degrees C ( Thermamed SmartCare OP ) , and 36.5 degrees C + /- 0.4 degrees C ( Allon 2001 ; P Perioperative blood loss was 2683 + /- 1049 mL ( Warm-Touch ) , 2300 + /- 788 mL ( Thermamed SmartCare OP ) , and 1497 + /- 497 mL ( Allon 2001 ; P = .195 , Warm-Touch vs Thermamed SmartCare OP ; P Transfusion requirements were 1097 + /- 874 mL ( Warm-Touch ) , 986 + /- 744 mL ( Thermamed SmartCare OP ) , and 431 + /- 387 mL ( Allon 2001 ; P = .838 , Warm-Touch vs Thermamed SmartCare OP ; P = .003 , Warm-Touch vs Allon 2001 ; P = .013 , Thermamed SmartCare OP vs Allon 2001 ) . Free of allogenic transfusion were 15 ( 51.7 % ; Warm-Touch ) , 18 ( 60 % ; Thermamed SmartCare OP ) , and 24 ( 82.8 % ; Allon 2001 ) patients ( P = .037 ) . CONCLUSIONS The goal of normothermia during off-pump coronary artery bypass grafting was best achieved by the Allon system . With this concept , overall blood loss and transfusion requirements were reduced , hence indicating improved quality of perioperative care",
"UNLABELLED Children are very sensible to the occurrence of intraoperative hypothermia ( HT ) ( core temperature during general anaesthesia because their regulation capacity is less effective than in adults and due to a large skin-surface area compared with their body mass . We compared the efficacy of different heating devices to prevent HT in children during surgery . METHODS With approval of the local ethics committee 50 children between one and seven years , scheduled for peripheral surgery lasting at least 2 hours were included in this study . Anaesthesia was st and ardized in all patients . Patients were r and omly divided into 5 groups . In group 1 , in addition to the usual cotton blankets , room temperature was elevated to 27 - 28 degrees C. In group 2 , room temperature was maintained at 27 - 28 degrees C , and the patients were additionally wrapped into an aluminum blanket . In group 3 , elevated room temperature was combined with a convective heating blanket . Patients in group 4 were warmed with an aluminum blanket , while the room temperature was maintained at 22 degrees C. In group 5 , room temperature was maintained at 22 degrees C and patients were warmed with a convective heating device ( Tab . 1 ) . Room and core body temperature ( tympanon membrane ) were continuously measured . ANOVA and Fisher 's exact Test ( significance level : p weight of the pediatric patients ( Tab . 2 ) . The core temperature decreased by -1.7 degrees C in group 1 . In group 4 core temperature decreased by -1.6 degrees C. Using a convective warming system in normal ambient temperature ( group 5 ) core temperature increased by 0.2 degree C and was as effective in the prevention of HT as group 2 . A significant increase in core temperature occurred in group 3 + 0.7 degree C ( Tab . 3 and Fig. 1 ) . DISCUSSION OR temperature seems to be a critical factor influencing heat loss . Increasing OR temperature and covering with cotton sheets was not effective in preventing the heat loss . Increasing room temperature in combination with aluminum sheets is one alternative to prevent HT . Our study shows that the use of a convective warming device prevents HT during a 2-hour surgery in young children even at a OR temperature of about 22 degrees C. In conclusion , in pediatric patients the use of a convective heating system proved to be an effective alternative to room heating",
"The efficacy of leg skin warming in preventing hypothermia and shivering was evaluated in two separate prospect i ve , r and omized trials in patients undergoing abdominal surgery . In the first trial , 22 patients were r and omized to receive no hypothermia prevention ( control group ) or active warming with an electric warming blanket ( electric blanket group ) . In the second trial 33 patients were r and omized to receive no hypothermia prevention ( control group ) or forced-air warming ( Bair Hugger ® group ) or forced-air warming with insulation of the air blanket from the environment ( insulated Bair Hugger ® group ) . The core and skin temperatures were measured and changes in body heat content calculated . In the first trial , core temperature was 34.6 ± 0.3 ° C at the end of surgery in the control group vs 36.4 ± 0.1 ° C in the electric warming blanket group ( P occurred in nine control patients and in one warmed patient ( P , core temperature was 35.1 ± 0.2 ° C at the end of surgery in the control group , 36.3 ± 0.1 ° C in the Bair Hugger ® group ( P Bair Hugger ® ) . Shivering occurred in one patient of each warmed group and in seven of the control group ( P 0.05 ) . Skin-surface warming limited to the legs provides sufficient heat ( ranging 34 to 43 watts ) to counterbalance heat losses during abdominal surgery",
"Background : The aim of this prospect i ve , controlled study was to evaluate the effects on coagulation function of active patient warming during elective plastic surgery . Methods : Seventy-six patients undergoing elective plastic surgery ( additive and reductive mastoplasty , rhinoplasty , and liposuction ) were either covered with st and ard sterile drapes ( control group , n = 38 ) or actively warmed during surgery with countercurrent fluid warming and forced-air skin warming ( treatment group , n = 38 ) . Complete evaluation of the coagulation activity was performed 1 hour before general anesthesia was induced and then at the end of surgery . Results : Although no differences in preoperative core temperature were observed ( 36.0 ± 0.5 ° C in the control group and 36.1 ± 0.4 ° C in the treatment group ; p = 0.12 ) , core temperature was lower at the end of surgery in the control group ( 34 ± 1.0 ° C ) than in the treatment group ( 36 ± 0.6 ° C ) ( p = 0.0005 ) . No differences in prothrombin time and fibrinogen plasma concentrations were observed between the two groups . At the end of surgery , control group patients showed significantly larger activated partial thromboplastin times ( 36.8 ± 3.5 seconds ) and bleeding times ( 8.1 ± 1.6 minutes ) as compared with patients maintained normothermic during surgery ( 34.0 ± 2.9 seconds and 4.3 ± 1.1 minutes ; p = 0.0005 and p = 0.0005 , respectively ) . Conclusion : Actively maintaining intraoperative normothermia allows patients to maintain normal coagulation function during elective plastic surgery lasting longer than 2 hours , potentially reducing the occurrence of bleeding-related complications after plastic surgery",
"In this trial we compared the hypothermia avoidance abilities of the A rct ic Sun ® Temperature Management System ( a servo-regulated system that circulates temperature-controlled water through unique energy transfer pads adherent to the patient ’s body ) with conventional temperature control methods . Patients undergoing off-pump coronary artery bypass ( OPCAB ) surgery were r and omized to either the A rct ic Sun System alone ( AS group ) or conventional methods ( control group ; increased room temperature , heated IV fluids , convective forced air warming system ) for the prevention of hypothermia ( defined by a temperature temperature servo-regulated to a target of 36.8 ° C . Temperature was recorded throughout the operative period and comparisons were made between groups for both the time and area under the curve ( AUC ) for a temperature Twenty-nine patients ( AS group = 14 , control group = 15 ) were studied . The AS group had significantly less hypothermia than the control group , both for duration of time The A rct ic Sun Temperature Management System significantly reduced intraoperative hypothermia during OPCAB surgery . Importantly , this was achieved in the absence of any other temperature modulating techniques , including the use of IV fluid warming or increases in the ambient operating room temperature ",
"OBJECTIVE To determine whether the application of warmth after hernia surgery reduces pain and aids wound healing . METHOD Forty-five patients were recruited and r and omised to receive either no warming;two hours of warming immediately after surgery ; or seven days of warming . RESULTS Postoperative pain scores were significantly lower after two hours of warming immediately after surgery compared with the non-warmed patients ( p Pain scores were lower on each of the first seven postoperative days in the warmed groups compared with the non-warmed subjects . Patients in the warmed groups also had lower ASEPSIS wound scores . CONCLUSION Warming may allow wounds to heal with fewer complications . In addition , warming for only two hours immediately after surgery may provide similar benefits to seven days of warming",
"ZusammenfassungHintergrundHypothermia ist ein oft beobachtbares Phänomen bei Traumapatienten während der Akutversorgung . Bekannte Komplikationen einer akzidentellen Hypothermie sind Wundheilungsstörungen , kardiale Komplikationen , hämodynamische Instabilität , Defizite i m Immunsystem und vermehrter Blutverlust . In der folgenden Studie verglichen wir passiv gewärmte vs. aktiv gewärmte Patienten auf dem Transport von einer Intensivstation zum CT . Method enDreißig Intensivpatienten wurden r and omisiert zur einer aktiv gewärmten Gruppe , abgedeckt mit einer Carbonfiberwärmedecke ( 42 ° C ) während des gesamtem Transport und zur einer passiv gewärmten Gruppe , die mit einer ausgeschalteten Carbonfiberdecke versorgt waren . In beiden Gruppen waren die Carbonfiberdecke mit konventionellen Wolldecken abgedeckt . Es wurden die Vitalparameter und die Körpertemperaturen gemessen . ErgebnisseDie Ausgangs date n der Patienten waren in beiden Gruppen vergleichbar . Die Ausgangstemperatur in Gruppe A war 36,4 ° C±0,2 ° C und blieb stabil bei 36,4 ° C±01 ° C , die Temperatur in Gruppe B startete bei 36,4 ° C±0,2 ° C und sank statistisch signifikant auf 34,7 ° C±0,6 ° C.SchlussfolgerungenDie Hypothermie ist ein gängiges Problem , wenn Patienten wegen der diagnostischen Maßnahme einen innerklinischen Transport benötigen . Das aktive Wärmen dieser Patienten während des Transports kann die Körpertemperatur stabil normotherm halten . We können daher zur Erhaltung der Normothermia das aktive Wärmen von Patienten während eines Transports empfehlen . Summary Objective Hypothermia in trauma victims is a frequently observed phenomenon in acute care . Known complications of hypothermia are impaired wound healing , cardiac complications , hemodynamic instability , impaired immune function and increased blood loss . We compared active warming versus passive warming in hypothermia in critical-care patients undergoing intrahospital transfer from ICU to computer tomography ( CT ) . Methods Thirty critically ill patients were r and omized either to an actively warmed group , covered with a carbon-fiber heating blanket ( set to 42 ° C ) during the entire transport including the time spent in the CT , or to a passively warmed group , covered with a carbon-fiber heating blanket ( switched off ) during the entire transport and in the CT . The carbon-fiber blanket was covered with a conventional wool blanket in both groups . Vital parameters and core temperatures were recorded . Results Patients ’ characteristics and vital parameters were similar in each treatment group . Initial average core temperature in group A was 36.4 ° C±0.2 ° C and remained stable at 36.4 ° C±0.1 ° C ; core temperature in group B started at 36.4 ° C±0.2 ° C but decreased to 34.7 ° C±0.6 ° C . Conclusions Hypothermia is common when critically ill trauma patients require intrahospital transport for diagnostic procedures . Resistive heating during intrahospital transport kept the core temperature stable and assured normothermia in all actively warmed patients . We therefore recommend active warming for critically ill trauma patients during intrahospital transport",
"BACKGROUND Wound infection after clean surgery is an expensive and often underestimated cause of patient morbidity , and the benefits of using prophylactic antibiotics have not been proven . Warming patients during colorectal surgery has been shown to reduce infection rates . We aim ed to assess whether warming patients before short duration , clean surgery would have the same effect . METHODS 421 patients having clean ( breast , varicose vein , or hernia ) surgery were r and omly assigned to either a non-warmed ( st and ard ) group or one of two warmed groups ( local and systemic ) . We applied warming for at least 30 min before surgery . Patients were followed up and masked outcome assessment s made at 2 and 6 weeks . FINDINGS Analysis was done on an intention-to-treat basis . We identified 19 wound infections in 139 non-warmed patients ( 14 % ) but only 13 in 277 who received warming ( 5 % ; p=0.001 ) . Wound scores were also significantly lower ( p=0.007 ) in warmed patients . There was no significant difference in the development of haematomas or seromas after surgery but the non-warmed group were prescribed significantly more postoperative antibiotics ( p=0.002 ) . INTERPRETATION Warming patients before clean surgery seems to aid the prevention of postoperative wound infection . If applied according to the manufacturers guidelines these therapies have no known side-effects and might , with the support of further studies , provide an alternative to prophylactic antibiotics in this type of surgery",
"Background and objective Hypothermia may alter the disposition of opioids . Because opioids are commonly used as analgesics in the postoperative period , it is of clinical interest to clarify whether perioperatively developed hypothermia affects postoperative opioid requirements . Methods Fifty-nine patients undergoing subtotal hysterectomy were prospect ively r and omized and either treated intraoperatively with forced air warming , or served as controls covered with conventional blankets without active warming . Both groups received postoperative patient-controlled analgesia with the opioid ketobemidone . Total analgesic requirements , dem and s , analgesic requirements over 6-h intervals and pain scores were measured for 48 h. Core temperature at the tympanic membrane and ambient room temperature were measured during the perioperative period . Results There were no postoperative differences in analgesic requirements or pain intensity between normothermic and hypothermic patients . Patients treated with warm air had an up to 1 ° C higher core temperature from 0.5 h after anaesthesia induction until almost 2 h postoperatively . The actively warmed patients also had a lower intraoperative blood loss than the hypothermic patients ( 186 ± 27 mL vs. 308 ± 47 mL;P , opioid requirements do not seem to be affected by mild postoperative hypothermia after lower abdominal surgery",
"Background : In a prospect i ve , r and omized , placebo‐controlled study we investigated the efficacy of 2 different heating methods in 24 patients undergoing abdominal surgery of at least 2 h expected duration",
"Anesthesiologists attempt to maintain perioperative normothermia for surgical patients . We surveyed clinical anesthesiologists and physician research ers and asked them to prioritize risk factors for a patient to develop intraoperative hypothermia . The question naire included 41 factors associated with changes in patient temperature identified during a computerized literature search . We asked respondents to estimate the relative importance of each risk factor on a 10-point scale . The survey was mailed to two groups : 1 ) 180 anesthesiologists ( n = 84 respondents ) r and omly selected from the 1999 American Society of Anesthesiologists Members Directory and to 2 ) 24 physician research ers ( n = 12 respondents ) in thermoregulation . Research ers rated the following to be the most important risk factors for hypothermia ( in sequence ) : neonates , a low ambient operating room temperature , burn injuries , general anesthesia with neuraxial anesthesia , geriatric patients , low temperature of the patient before induction , a thin body type , and large blood loss . The results for the clinician group were similar , because the median differences between the groups ’ results were two or fewer units for all items . The risk factors identified to be most important can now be further evaluated in clinical trials to develop a multivariate predictive tool for calculating a patient ’s a priori risk for developing hypothermia",
"BACKGROUND Destruction by oxidation , or oxidative killing , is the most important defense against surgical pathogens and depends on the partial pressure of oxygen in contaminated tissue . An easy method of improving oxygen tension in adequately perfused tissue is to increase the concentration of inspired oxygen . We therefore tested the hypothesis that the supplemental administration of oxygen during the perioperative period decreases the incidence of wound infection . METHODS We r and omly assigned 500 patients undergoing colorectal resection to receive 30 percent or 80 percent inspired oxygen during the operation and for two hours afterward . Anesthetic treatment was st and ardized , and all patients received prophylactic antibiotic therapy . With use of a double-blind protocol , wounds were evaluated daily until the patient was discharged and then at a clinic visit two weeks after surgery . We considered wounds with culture-positive pus to be infected . The timing of suture removal and the date of discharge were determined by the surgeon , who did not know the patient 's treatment-group assignment . RESULTS Arterial oxygen saturation was normal in both groups ; however , the arterial and subcutaneous partial pressure of oxygen was significantly higher in the patients given 80 percent oxygen than in those given 30 percent oxygen . Among the 250 patients who received 80 percent oxygen , 13 ( 5.2 percent ; 95 percent confidence interval , 2.4 to 8.0 percent ) had surgical-wound infections , as compared with 28 of the 250 patients given 30 percent oxygen ( 11.2 percent ; 95 percent confidence interval , 7.3 to 15.1 percent ; P=0.01 ) . The absolute difference between groups was 6.0 percent ( 95 percent confidence interval , 1.2 to 10.8 percent ) . The duration of hospitalization was similar in the two groups . CONCLUSIONS The perioperative administration of supplemental oxygen is a practical method of reducing the incidence of surgical-wound infections",
"Background : Intraoperative hypothermia initially results from internal redistribution of heat facilitated by anesthesia-induced vasodilatlon . Preinductlon skin-surface warming minimizes postinduction hypothermia in anesthetized volunteers . However , its efficacy might be reduced in surgical situations , because of multiple sources of heat loss . Methods : Intraoperative core and mean skin temperatures were measured during total hip arthroplasty in 16 patients , r and omly assigned to be covered preoperatlvely with a warming blanket for ≥90 min ( prewarmed group ) or not covered ( unwarmed group ) . Results : During the first hour of anesthesia , core temperature decreased more than twice as much in the unwarmed group ( −0.7 ± 0.1 ° C ; mean ± SE ) than in the prewarmed patients ( −0.3 ± 0.1 ° C ) . At the end of surgery , core temperature was 36.3 ± 0.1 ° C in the prewarmed group and 35.2 ± 0.2 ° C in the unwarmed group . During recovery , seven patients obviously shivered in the unwarmed group and none in the prewarmed group . Conclusions : Preanesthetic skin-surface warming reduces the initial postinductlon hypothermia in surgical patients , preventing intraoperative hypothermia and postoperative shivering even for procedures lasting 3 h or longer",
"Actively warming patients during surgery is considered the best method of preventing inadvertent hypothermia . In order to investigate the effect of forced air warming on postoperative oxygen consumption , we studied 26 patients undergoing orthopaedic surgery using a prospect i ve , r and omized trial design . We measured oxygen consumption , carbon dioxide production , temperature , thermal comfort and pain scores . Apart from intraoperative temperature , there were no significant differences in these measurements between the two groups . This study demonstrated the gradual heat gain and also the potential for hyperthermia from pre- and intraoperative forced air warming . We conclude that forced air warming is not necessary for moderate duration non-body-cavity surgery if effective preinduction covering of patients and minimal surgical exposure is achieved",
"Background Hypothermia occurs commonly during surgery and can be associated with increased metabolic dem and s during rewarming in the postoperative period . Although cardiac complications remain the leading cause of morbidity after anesthesia and surgery , the relationship between unintentional hypothermia and myocardial ischemia during the perioperative period has not been studied . Methods One hundred patients undergoing lower extremity vascular reconstruction received continuous Hotter monitoring throughout the first 24 h postoperatively . Myocardial ischemia was determined by a cardiologist masked to clinical variables . The patient 's sublingual temperature on arrival at the intensive care unit immediately after the surgical procedure was used to divide the patients into two groups : hypothermic ( temperature , normothermic ( temperature , ≤ 35 ° C ; n = 67 ) . The relationship between unintentional hypothermia and myocardial ischemia occurring during the first postoperative day was evaluated by univariate and multivariate analyses . Results A greater percentage of patients had electrocardiographic changes consistent with myocardial ischemia in the hypothermic group ( 36 % , 12 of 33 ) compared with those in the normothermic group ( 13 % , 9 of 67 , P = 0.008 ) . Preoperative risk factors for perioperative cardiac morbidity were similar between the two groups , except for patient age . The mean age was 70 ± 2 yr and 62 ± 1 yr in the hypothermic and normothermic groups , respectively ( P = 0.001 ) . When subgroup and multivariate analyses were used to adjust for differences in age , temperature remained an independent predictor of ischemia ( odds ratio , 1.82 per degree Celsius ; 95 % confidence interval , 1.09–3.02 ) . The incidence of postoperative angina was greater in the hypothermic group ( 18 % , 6 of 33 ) than in the normothermic group ( 1.5 % , 1 of 67 , P = 0.002 ) . The incidence of PaO2 was greater in the hypothermic group ( 52 % , 17 of 33 ) than in the normothermic group ( 30 % , 20 of 67 , P = 0.03 ) . Conclusions Unintentional hypothermia is associated with myocardial ischemia , angina , and PaO2 < 80 mmHg during the early postoperative period in patients undergoing lower extremity vascular surgery"
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BACKGROUND Panic disorder is characterised by recurrent unexpected panic attacks consisting of a wave of intense fear that reaches a peak within a few minutes . Panic disorder is a common disorder , with an estimated lifetime prevalence of 1 % to 5 % in the general population and a 7 % to 10 % prevalence in primary care setting s. Its aetiology is not fully understood and is probably heterogeneous . Panic disorder is treated with psychological and pharmacological interventions , often used in combination . Although benzodiazepines are frequently used in the treatment of panic disorder , guidelines recommend antidepressants , mainly selective serotonin reuptake inhibitors ( SSRIs ) , as first-line treatment for panic disorder , particularly due to their lower incidence of dependence and withdrawal reaction when compared to benzodiazepines . Despite these recommendations , benzodiazepines are widely used in the treatment of panic disorder , probably because of their rapid onset of action . OBJECTIVES To assess the efficacy and acceptability of benzodiazepines versus placebo in the treatment of panic disorder with or without agoraphobia in adults . SEARCH METHODS We search ed the Cochrane Common Mental Disorders Controlled Trials Register ( CCMDCTR Studies and References ) , the Cochrane Central Register of Controlled Trials ( CENTRAL ) , MEDLINE ( 1950- ) , Embase ( 1974- ) , and PsycINFO ( 1967- ) up to 29 May 2018 . We h and search ed reference lists of relevant papers and previous systematic review s. We contacted experts in the field for supplemental data . SELECTION CRITERIA All double-blind ( blinding of patients and personnel ) controlled trials r and omising adults with panic disorder with or without agoraphobia to benzodiazepine or placebo . DATA COLLECTION AND ANALYSIS Two review authors independently checked the eligibility of studies and extracted data using a st and ardised form . Data were then entered data into Review Manager 5 using a double-check procedure . Information extracted included study characteristics , participant characteristics , intervention details , setting s , and outcome measures in terms of efficacy , acceptability , and tolerability . MAIN RESULTS We included 24 studies in the review with a total of 4233 participants , of which 2124 were r and omised to benzodiazepines and 1475 to placebo . The remaining 634 participants were r and omised to other active treatments in three-arm trials . We assessed the overall method ological quality of the included studies as poor . We rated all studies as at unclear risk of bias in at least three domains . In addition , we judged 20 of the 24 included studies as having a high risk of bias in at least one domain . Two primary outcomes of efficacy and acceptability showed a possible advantage of benzodiazepines over placebo . The estimated risk ratio ( RR ) for a response to treatment was 1.65 ( 95 % confidence interval ( CI ) 1.39 to 1.96 ) in favour of benzodiazepines , which corresponds to an estimated number needed to treat for an additional beneficial outcome ( NNTB ) of 4 ( 95 % CI 3 to 7 ) . The dropout rate was lower among participants treated with benzodiazepines ( RR 0.50 , 95 % CI 0.39 to 0.64 ) ; the estimated NNTB was 6 ( 95 % CI 5 to 9 ) . We rated the quality of the evidence as low for both primary outcomes . The possible advantage of benzodiazepine was also seen for remission ( RR 1.61 , 95 % CI 1.38 to 1.88 ) and the endpoint data for social functioning ( st and ardised mean difference ( SMD ) -0.53 , 95 % CI -0.65 to -0.42 ) , both with low- quality evidence . We assessed the evidence for the other secondary outcomes as of very low quality . With the exception of the analyses of the change score data for depression ( SMD -0.22 , 95 % CI -0.48 to 0.04 ) and social functioning ( SMD -0.32 , 95 % CI -0.88 to 0.24 ) , all secondary outcome analyses showed an effect in favour of benzodiazepines compared to placebo . However , the number of dropouts due to adverse effects was higher with benzodiazepines than with placebo ( RR 1.58 , 95 % CI 1.16 to 2.15 ; low- quality evidence ) . Furthermore , our analyses of adverse events showed that a higher proportion of participants experienced at least one adverse effect when treated with benzodiazepines ( RR 1.18 , 95 % CI 1.02 to 1.37 ; low- quality evidence ) . AUTHORS ' CONCLUSIONS Low- quality evidence shows a possible superiority of benzodiazepine over placebo in the short-term treatment of panic disorders . The validity of the included studies is question able due to possible unmasking of allocated treatments , high dropout rates , and probable publication bias . Moreover , the included studies were only short-term studies and did not examine the long-term efficacy nor the risks of dependency and withdrawal symptoms . Due to these limitations , our results regarding the efficacy of benzodiazepines versus placebo provide only limited guidance for clinical practice . Furthermore , the clinician 's choice is not between benzodiazepines and placebo , but between benzodiazepines and other agents , notably SSRIs , both in terms of efficacy and adverse effects . The choice of treatment should therefore be guided by the patient 's preference and should balance benefits and harms from treatment in a long-term perspective | [
"The efficacy of tricyclics and benzodiazepines in the short term ( approximately 2 - 4 months ) treatment of panic disorder is well demonstrated , but efficacy over the longer term is not considered established . The present study provided systematic data from a double blind comparison of maintenance therapy ( up to 8 months ) of panic disorder with or without agoraphobia with alprazolam , imipramine , or placebo in 181 patients who had responded to the same regimen in a r and omized 8-week treatment trial . All three groups had improved during the first 2 months ( active treatments more than placebo and about equal to each other ) , and all maintained or extended their improvement over the next 6 months without any significant change in dose . More than twice as many alprazolam and imipramine than placebo patients ( 15 % ) remained in treatment for the full 8 months and did slightly better on symptom measures than the remaining placebo patients . Both medications were well tolerated during the maintenance period . The data suggest sustained efficacy and safety of imipramine and alprazolam over an extended period . More specifically , they suggest that tolerance does not develop to the therapeutic effects of either drug",
"CONTEXT Previous studies indicate that industry-sponsored trials tend to draw proindustry conclusions . OBJECTIVE To explore whether the association between funding and conclusions in r and omized drug trials reflects treatment effects or adverse events . DESIGN Observational study of 370 r and omized drug trials included in meta-analyses from Cochrane review s selected from the Cochrane Library , May 2001 . From a r and om sample of 167 Cochrane review s , 25 contained eligible meta-analyses ( assessed a binary outcome ; pooled at least 5 full-paper trials of which at least 1 reported adequate and 1 reported inadequate allocation concealment ) . The primary binary outcome from each meta- analysis was considered the primary outcome for all trials included in each meta- analysis . The association between funding and conclusions was analyzed by logistic regression with adjustment for treatment effect , adverse events , and additional confounding factors ( method ological quality , control intervention , sample size , publication year , and place of publication ) . MAIN OUTCOME MEASURE Conclusions in trials , classified into whether the experimental drug was recommended as the treatment of choice or not . RESULTS The experimental drug was recommended as treatment of choice in 16 % of trials funded by nonprofit organizations , 30 % of trials not reporting funding , 35 % of trials funded by both nonprofit and for-profit organizations , and 51 % of trials funded by for-profit organizations ( P funding , treatment effect , and double blinding were the only significant predictors of conclusions . Adjusted analyses showed that trials funded by for-profit organizations were significantly more likely to recommend the experimental drug as treatment of choice ( odds ratio , 5.3 ; 95 % confidence interval , 2.0 - 14.4 ) compared with trials funded by nonprofit organizations . This association did not appear to reflect treatment effect or adverse events . CONCLUSIONS Conclusions in trials funded by for-profit organizations may be more positive due to biased interpretation of trial results . Readers should carefully evaluate whether conclusions in r and omized trials are supported by data",
"Seventy-nine patients with panic disorder were r and omized to an 8-week double-blind treatment with alprazolam , imipramine , or placebo . Patients kept daily records of panic attacks , activity , anxiety , sleep , and medication use . Weekly measures of anxiety , depression , somatic symptoms , fears , avoidance , disability , and improvement were obtained . All patients underwent a symptom-limited exercise treadmill and other cardiovascular measures . By physician and patient global assessment , patients receiving alprazolam or imipramine were significantly better than patients on placebo . The alprazolam effects were apparent by week 1 ; the imipramine effects by week 4 . All groups showed significant reductions in anxiety , depression , somatic measures , and panic attack frequency . At 8 weeks , patients in the alprazolam group reported significantly less fear than patients in the other two groups . Subjects in the imipramine group showed a significant increase in heart rate and blood pressure",
" The paper consists of two parts . A review of the relationship of panic disorder to the phobic states and the treatment of these disorders by means of tricyclic antidepressants , MAOIs , beta blocking drugs and benzodiazepines . A double blind study of alprazolam and placebo in 118 patients with agoraphobia and panic is presented . In an eight week study alprazolam was found to be significantly superior to placebo in the treatment of panic attacks , phobic avoidance , anticipatory anxiety and general anxiety",
"BACKGROUND The serotonin selective reuptake inhibitors are increasingly being used for the treatment of panic disorder . We examined the efficacy and safety of the serotonin selective reuptake inhibitor sertraline hydrochloride in patients with panic disorder . METHODS One hundred seventy-six nondepressed out patients with panic disorder , with or without agoraphobia , from 10 sites followed identical protocol s that used a flexible-dose design . After 2 weeks of single-blind placebo , patients were r and omly assigned to 10 weeks of double-blind , flexible-dose treatment with either sertraline hydrochloride ( 50 - 200 mg/d ) or placebo . RESULTS Sertraline-treated patients exhibited significantly greater improvement ( P=.01 ) at end point than did patients treated with placebo for the primary outcome variable , panic attack frequency . Significant differences between groups were also evident for clinician and patient assessment s of improvement as measured by the Clinical Global Impression Improvement ( P=.01 ) and Severity ( P=.009 ) Scales , Panic Disorder Severity Scale ratings ( P=.03 ) , high end-state function assessment ( P=.03 ) , Patient Global Evaluation rating ( P=.01 ) , and quality of life scores ( P=.003 ) . Adverse events , generally characterized as either mild or moderate , were not significantly different in overall incidence between the sertraline and placebo groups . CONCLUSION Results support the safety and efficacy of sertraline for the short-term treatment of patients with panic disorder",
"This paper presents findings from a multisite study of 126 subjects meeting DSM-III-R criteria for Panic Disorder who also met criteria for a concurrent Major Depressive Episode , Dysthymia , or Depressive Disorder NOS . The study 's primary aim was to discern the influence of varying degrees of depression on the comparative efficacy of alprazolam , imipramine and placebo on anxiety outcomes . A placebo-controlled , double-blind , parallel r and om assignment design was utilized over a total of 16 weeks . There was no medication effect on panic outcomes . At endpoint , percent of anticipatory anxiety ( i.e. , time spent worrying about having an anxiety attack ) was significantly lower in the patients taking active medications vs. placebo . Phobic measures were significantly improved by alprazolam , vs. both imipramine and placebo early in the study ; however , by week 8 both active medications were equally superior to placebo in the reduction of phobic symptoms . In addition , both active medications were significantly more effective than placebo in reducing depression . The same efficacy pattern ( i.e. , active medications superior to placebo ) was observed on measures of general functioning . Importantly , there were no significant interactions observed between medication and presence of major depression on the depression measures , indicating that both alprazolam and imipramine were equally efficacious in treating the depression in patients with panic disorder and major depression . Since the patients enrolled in this study suffered from major depressive disorder in the mild to moderate severity range , these results may not be transferrable to patients with panic disorder and severe major depression",
"This study examines clinical predictors of outcome for patients with panic disorder and depression in a 16 week , placebo-controlled trial of alprazolam and imipramine ( n = 126 ) . Baseline global severity of illness and phobic avoidance were differentially predictive of acute response to treatment . Patients in the mild to moderate range of global distress experienced smaller degrees of improvement on alprazolam than on imipramine at week 4 . At endpoint , the relative effectiveness of the active medication versus placebo was diminished in patients with higher levels of phobic avoidance . This relationship was not evident for completers , suggesting that the adverse effects of avoidance on outcome after sustained treatment was reduced",
"This paper reports the results of a double-blind comparison of fixed daily doses of 6 mg of alprazolam , 2 mg of alprazolam , 225 mg of imipramine , and placebo for 8 weeks in 81 patients who met DSM-III criteria for panic disorder with or without agoraphobia . Final scores on eight clinical measures were analyzed from all patients who entered the study and from the subset who completed at least 4 weeks of treatment . Eighty-six percent of the high-dose alprazolam patients completed the study . Only 50 % of the imipramine patients completed 8 weeks of treatment , apparently because of activation early in treatment and slow onset of therapeutic effects . This study confirmed the therapeutic effectiveness and safety of alprazolam , especially at the higher dose , in panic disorder . It also confirmed the therapeutic effectiveness of imipramine among patients who tolerated the drug . It suggested the usefulness of a flexible , individual approach to dose escalation with imipramine . Method ologically the study underscored the importance of using multiple approaches to the analysis of clinical data from therapeutic trials of psychotropic agents with complex effects that may contribute to patients ' premature termination",
"Date from a panic disorder treatment study with 506 patients , comparing alprazolam and placebo in a double-blind manner for 8 weeks , were analyzed to identify demographic and clinical characteristics of the patients that might predict response to treatment . The strongest predictors of response to alprazolam were age over 40 , and lower baseline levels of anxiety and phobic symptoms . Predictors of response to placebo were weaker and , in addition to lower levels anxiety and panic attacks , included a lack of previous psychiatric treatment",
"A recently reported multinational , 8-week double-blind , placebo-controlled study assessing the efficacy of alprazolam versus placebo in the treatment of panic disorder indicated significant differences favoring alprazolam . We now report the results of a three-site , 6-week , double-blind , fixed-dose study comparing alprazolam 2 mg , alprazolam 6 mg , and placebo in 94 patients with panic disorder with or without agoraphobia . Both alprazolam treatment groups ( 6 mg and 2 mg ) improved significantly more than did the placebo treatment group on most outcome measures . Only a few statistically significant differences between the 6 mg and 2 mg alprazolam groups were discerned , although the pattern of treatment response across measures suggested a dose effect . Dropouts in the placebo group were primarily due to lack of efficacy and in the alprazolam 6 mg group were due to side effects , which may have contributed to the limited differences between groups at study end . The findings suggest that many patients may require less than 6 mg of alprazolam per day for effective treatment of panic disorder",
"OBJECTIVE Recently , pharmacological treatment guidelines for panic disorder have changed as newer treatment options have become available . The authors examined how the use of psychotropic drugs has shifted over the course of 10 years to determine if prescribing patterns have changed to reflect these revised treatment guidelines . METHOD A total of 443 patients with panic disorder were enrolled in the Harvard/Brown Anxiety Research Project , a prospect i ve longitudinal study of anxiety disorders . These patients were interviewed over the course of 10 years to examine their use of psychotropic medications . RESULTS Despite efforts aim ed at increasing the use of selective serotonin reuptake inhibitors ( SSRIs ) in patients with panic disorder ( e.g. , APA 's practice guideline for panic disorder , Food and Drug Administration approval of particular SSRIs for the treatment of panic disorder ) , only a modest increase in their use was found . Treatment patterns for psychotropic drugs appear to have remained stable over the past decade , with benzodiazepines being the most commonly used medication for panic disorder . In comparison , SSRI use throughout the follow-up period has remained low . Patients using an SSRI did not have a more favorable clinical course than those using a benzodiazepine , nor were there significantly better rates of remission in patients using SSRIs and benzodiazepines concomitantly . CONCLUSIONS These results highlight a gap between pharmacological treatment guidelines and actual delivery of care in that recommendations to use SSRIs to treat panic disorder are not being followed . Factors potentially associated with promoting and ignoring treatment recommendations are discussed",
"Two hundred six out patients with panic disorder and agoraphobia were r and omly assigned to receive 4 weeks of treatment with placebo or sustained-release adinazolam under double-blind conditions . Eighty-eight percent of patients receiving drug and 85 % of patients receiving placebo remained in the study at week 4 . This report describes the “ intent-to-treat ” analysis of 202 patients who made at least one follow-up visit after r and omization at baseline . On the basis of the Clinical Global Impressions-Improvement Scale , 69.7 % of the adinazolam-treated patients were much or very much improved compared with 39.6 % of the placebo-treated patients at week 4 or end-point ( p = 0.0001 ) . At week 4 , panic attacks were completely blocked in 57.1 % of adinazolam-treated patients and in 39.2 % of the placebo-treated patients ( p = 0.009 ) . Adinazolam sustained-release treatment was statistically more effective than placebo treatment on measures of global improvement , number of panic attacks , SCL-90 phobia severity , main phobia severity , and anticipatory and general anxiety . No drug-placebo differences were found for overall self-rated phobia severity , unexpected or situational panic attacks , or for work , family , or social disability",
"Thirty-seven severely-disabled agoraphobics were r and omly assigned to ( 1 ) Imipramine-no exposure . ( 2 ) Imipramine + exposure or ( 3 ) Placebo + exposure groups . To provide a more stringent test of the pharmacological effects of imipramine independent of exposure to phobic stimuli , Ss in the Imipramine-no exposure condition received antiexposure instructions during the first 8 weeks of therapy . Assessment s were conducted at 0 , 8 and 26 weeks . At 8 weeks , the group receiving imipramine combined with exposure therapy displayed more improvement than the other two groups , and was the only group to show a reduction in panic attacks . Ss receiving imipramine with antiexposure instructions showed little improvement on phobic indices , no reduction in panic , but significant improvement in anxiety and dysphoric mood . At 26 weeks Ss receiving the combined imipramine + exposure treatment exhibited further improvement result ing in a significant superiority of Imipramine + exposure over Placebo + exposure across a number of different outcome indices . Ss who had received imipramine with antiexposure instructions showed some improvement during the subsequent 18 weeks in which the antiexposure instructions were no longer in effect . However , neither this group nor the Placebo + exposure group showed a reduction in panic attacks . The results of the present trial provide support for the beneficial effects of combining intensive exposure with imipramine , but call into question the thesis that imipramine exerts its effect through a pharmacological blocking of panic attacks . Alternative hypotheses concerning the mode of action of imipramine are presented",
"Patients with panic disorder ( N = 1168 ) were enrolled in a multicenter , 8-week , double-blind clinical trial of imipramine , alprazolam , and placebo to analyze whether the effectiveness of these agents is dependent on the depressive/dysphoric symptomatology which often coexists in panic disorder patients . In addition to analyses performed on the whole sample of patients , the authors conducted analyses on a sub sample ( N = 312 ) defined by multiple criteria to ensure the absence of depression and dysphoria . In both the overall sample and the nondepressed sub sample , the clinical response to imipramine or alprazolam was found to be independent of the presence of depression or dysphoria . In panic disorder patients for whom pharmacotherapy is being considered as treatment , the absence of depression is apparently not a contraindication",
"Urinary free cortisol ( UFC ) levels were measured at baseline and at four and eight weeks after initiation of treatment in 66 patients who met DSM-III-R criteria for primary panic disorder ( PD ) . Thirty-seven normal control subjects also had UFC levels measured three times at monthly intervals . Patients were r and omly assigned to treatment with alprazolam , diazepam , or placebo . At baseline , complicated PD patients ( those with agoraphobia and secondary depression ) had significantly higher UFC levels than did normal controls . At four and eight weeks , complicated PD patients receiving alprazolam and diazepam had significant reductions in UFC excretion compared to baseline . Patients with uncomplicated PD maintained UFC levels comparable to controls at each sampling period . Treatment with benzodiazepines did not lower UFC levels in this group . These findings suggest that patients with complicated PD demonstrate hyperactivity of the hypothalamo-pituitary-adrenal axis that is decreased by treatment with benzodiazepines",
"The relative effectiveness of the available treatments for panic disorder may best be understood in the context of the longitudinal course of the disorder . This study examines a number of clinical ly relevant issues , including long-term outcome after acute treatment , the proportion of patients remaining on single-agent treatment or requiring multiple medications or nonpharmacologic interventions over time , evidence for dose escalation during maintenance high-potency benzodiazepine therapy , and predictors of acute and long-term response to treatment . Fifty-nine panic disorder patients originally r and omized to treatment in a controlled trial comparing alprazolam , clonazepam , and placebo were reevaluated in a follow-up study . At a mean follow-up of 1.5 years , 78 % of patients remained on medication and the mean dosage of alprazolam and clonazepam did not increase . Our data suggest that most patients maintain benefit with long-term pharmacotherapy but that residual symptomatology may require more intensive or additional treatment strategies . Response at the endpoint of the acute trial was significantly associated with pretrial baseline Clinical Global Impression Scale score and the presence of dysthymia . Poor outcome at follow-up was associated with total duration of the disorder , agoraphobic subtype , and the presence of comorbid social phobia . We underscore the potential importance of comorbid affective and anxiety disorders as well as phobic patterns in determining long-term response to treatment",
"The authors assessed the effects of partial tapering followed by abrupt discontinuation of alprazolam , diazepam , and placebo in 40 patients with panic attacks . The anxiety scores and frequency of panic attacks of the three groups did not differ at the end of the initial 2-week taper , but 1 week after abrupt discontinuation of the remaining medication , patients formerly taking alprazolam had greater increases in anxiety but no more panic attacks than did the other patients . Because of low statistical power , differences in benzodiazepine half-lives , absence of multiple ratings , and imbalances between groups in clinical characteristics , these findings must be viewed as preliminary",
" Thirty-six patients with generalised anxiety disorder , panic disorder or agoraphobia with panic attacks , diagnosed by DSM-III criteria , were treated with a new non-benzodiazepine anti-anxiety drug , buspirone , and with diazepam and placebo , in a cross-over design . Each patient took buspirone , diazepam and placebo for one week each in flexible dosage and balanced order . Ratings of symptomatology using the Comprehensive Psychopathological Rating Scale were made after each week 's treatment and a sub-scale used for measuring anxiety change alone was used separately . There was no overall difference in efficacy between the drugs , but when the scores for individual symptoms were analysed , diazepam was significantly superior to the other treatments for the symptom of muscle tension only . The results suggest that the common practice of giving short-term therapy with tranquilising drugs for anxiety in primary care is pharmacologically suspect",
"BACKGROUND The Panic Disorder Severity Scale ( PDSS ) is promising to be a st and ard global rating scale for panic disorder . In order for a clinical scale to be useful , we need a guideline for interpreting its scores and their changes , and for defining clinical change points such as response and remission . METHODS We used individual patient data from two large r and omized controlled trials of panic disorder ( total n=568 ) . Study participants were administered the PDSS and the Clinical Global Impression (CGI)--Severity and --Improvement . We applied equipercentile linking technique to draw correspondences between PDSS and CGI-Severity , numeric changes in PDSS and CGI-Improvement , and percent changes in PDSS and CGI-Improvement . RESULTS The interpretation of the PDSS total score differed according to the presence or absence of agoraphobia . When the patients were not agoraphobic , score ranges 0 - 1 corresponded with \" Normal , \" 2 - 5 with \" Borderline , \" 6 - 9 with \" Slightly ill , \" 10 - 13 with \" Moderately ill , \" and 14 and above with \" Markedly ill . \" When the patients were agoraphobic , score ranges 3 - 7 meant \" Borderline ill , \" 8 - 10 \" Slightly ill , \" 11 - 15 \" Moderately ill , \" and 16 and above \" Markedly ill . \" The relationship between PDSS change and CGI-Improvement was more linear when measured as percentile change than as numeric changes , and was indistinguishable for those with or without agoraphobia . The decrease by 75 - 100 % was considered \" Very much improved , \" that by 40 - 74 % \" Much improved , \" and that by 10 - 39 % \" Minimally improved . \" CONCLUSION We propose that \" remission \" of panic disorder be defined by PDSS scores of five or less and its \" response \" by 40 % or greater reduction",
"Alprazolam is a widely used antianxiety agent , yet relatively little is known about the relationship between chronic oral doses and steady-state plasma levels . This study examines the relationship over a wide range of therapeutic doses . We conducted a parallel , double-blind , placebo-controlled study in 36 patients with agoraphobia with panic attacks , or panic disorder with limited phobic avoidance based on DSM- III criteria . Patients received alprazolam ( N = 25 ) or placebo ( N = 11 ) beginning at 1 mg/day and increased weekly until either a maximum tolerated dose or 10 mg/day was achieved . Dosages were then gradually tapered according to a predetermined schedule . The entire study period lasted 14 weeks . Laboratory and clinical assessment s were conducted weekly . Doses up to 6 mg/day were tolerated by 80 % of patients on alprazolam and doses of 10 mg/day were tolerated by 40 % of patients . Twenty-seven percent of the placebo patients reached 10 tablets/day . In the alprazolam group , the principal cause of intolerance was sedation . Throughout the study no significant changes in vital signs or laboratory parameters were observed . Steady state alprazolam , 4-hydroxy alprazolam , and α-hydroxy alprazolam plasma levels were linearly related to dose . A 1 mg dosage increment produced , on the average , a corresponding 10 ng/ml increase in steady state level of the parent drug . Significant response was observed in subjects who achieved concentrations greater than 20 ng/ml , with a maximum of 81 % of the sample s classified as re- sponders within the 60 ng/ml and above group . During taper , no severe withdrawal symptoms were noted ; 12 of 25 alprazolam patients , however , reported rebound anxiety ( anxiety rating scale scores higher than baseline ) , which occurred most commonly at the reduction from 1 mg to 0 mg",
"Clinical trials of drug treatments for psychiatric disorders commonly employ the parallel groups , placebo-controlled , repeated measure r and omized comparison . When patients stop adhering to their originally assigned treatment , investigators often ab and on data collection . Thus , non-adherence produces a monotone pattern of unit-level missing data , disabling the analysis by intent-to-treat . We propose an approach based on multiple imputation of the missing responses , using the approximate Bayesian bootstrap to draw ignorable repeated imputations from the posterior predictive distribution of the missing data , stratifying by a balancing score for the observed responses prior to withdrawal . We apply the method and some variations to data from a large r and omized trial of treatments for panic disorder , and compare the results to those obtained by the original analysis that used the st and ard ( endpoint ) method",
"Although panic disorder has been associated with impaired quality of life ( QOL ) and financial dependence , no prior study has examined whether a clinical intervention will improve these outcomes . This study examines the effects of clinical ly titrated doses of clonazepam versus placebo on QOL and work productivity ( WP ) in patients with panic disorder . QOL and WP were measured in conjunction with a r and omized , double-blind , placebo-controlled trial . The Medical Outcomes Study 36-Item Short Form Health Survey ( SF-36 ) and Work Productivity and Impairment question naire were used to assess QOL and WP , respectively . Baseline assessment s were obtained before r and omizing patients to receive clinical ly titrated doses of clonazepam or placebo . Follow-up assessment s were obtained after 6 weeks of therapy with the test drug or at premature termination from the study . Improvement on the SF-36 Mental Health Component Summary scale was more than twice as great with clonazepam than with placebo ( P = 0.03 ) . Clonazepam patients improved ( P measures of mental health-related QOL , and both measures of physical health-related QOL , and both measures of WP . Placebo patients improved on three of five measures of mental health-related QOL , but on no other measures . Patients with marked improvements on clinical measures of panic disorder severity , especially avoidance and fear of the main phobia , showed the greatest gains on the SF-36 Mental Health Component Summary scale . Clinical ly titrated doses of clonazepam significantly improved mental health-related QOL and WP in panic disorder patients . Lesser improvements were obtained with placebo",
"One hundred six patients diagnosed according to DSM-III as suffering from agoraphobia with panic disorder , panic disorder with limited phobic avoidance , or uncomplicated panic disorder entered an acute 8-week treatment phase . Patients who improved received an additional 6 months ' maintenance treatment . Significantly more patients treated with alprazolam than with imipramine hydrochloride or placebo remained in therapy and experienced panic attack and phobia relief during the acute treatment phase . During the maintenance phase , neither tolerance nor daily dose increase was observed . All patients who completed the maintenance phase ( 27 in the alprazolam group , 11 in the imipramine group , and 10 in the placebo group ) were panic free at the end of 8 months of study treatment . Alprazolam therapy was effective and well tolerated at a mean daily dose of 5.7 mg . Imipramine hydrochloride ( 175 mg/d ) also produced significant panic relief but was associated with poor patient acceptance",
"Objective : To examine the correlates of therapeutic response of patients with panic disorder presenting with palpitations , we hypothesized that therapeutic response would correlate with heart rate variability ( HRV ) and sleep measures . Methods : After a 1-week placebo washout , 27 patients free of structural heart disease and not on cardioactive drugs were r and omized in a double-blinded fashion to 4 weeks of treatment with clonazepam ( a known antipanic agent ) or placebo . We performed st and ard sleep measures and recorded HRV from 24-hour Holter acquisitions at baseline and end of study . We defined response to therapy as a 50 % improvement in the Hamilton Anxiety Rating Scale ( HARS ) score , confirmed by question naires and reaction to sodium lactate infusion . Results : There were 12 responders and 15 nonresponders . Normalization of sleep pattern ( including less stage 1 and rapid eye movement [ REM ] sleep ) was observed in both drug and placebo responders ( P = 0.011 and P = 0.05 , respectively ) and in placebo responders alone , compared with nonresponders ( P = 0.006 and P = 0.013 , respectively ) . Placebo responders were more likely to show less depression , but even after we controlled for depression , main sleep effects remained . None of the HRV measures correlated with response , but compared with placebo , clonazepam led to a decrease in all the time and frequency domain measures of HRV ( all P patients with panic disorder presenting with palpitations , but this does not directly correlate with HRV . Larger and longer studies may allow objective explanations of placebo response in panic disorder",
"OBJECTIVE Placebo effects in treatment of three anxiety disorders were compared . METHOD Treatment response and patients ' treatment expectancy were examined by using data from 70 patients with obsessive-compulsive disorder , social phobia , or panic disorder who received placebo in three r and omized , controlled trials comparing cognitive behavior therapy , medication , and their combination to placebo . RESULTS Patients with obsessive-compulsive disorder were less likely to respond to placebo than patients with generalized social phobia or panic disorder . Differential expectancy did not account for these findings . CONCLUSIONS Further examination of the placebo effect across the anxiety disorders may eluci date maintenance mechanisms of these disorders and have implication s for development of more effective treatments",
"The effect of β 2-adrenoceptor antagonism in acute anxiety neurosis was investigated by comparing the effects of ICI 118,551 , a specific β2-adrenoceptor antagonist , diazepam and placebo in a double-blind , parallel group study . Sixty-three patients , who fulfilled criteria for Anxiety Disorder ( DSM III ) and were psychotropic drug- free ( apart from six using hypnotics ) , were entered . Anxiety symptoms were rated using the Hamilton Anxiety Scale ( HAS ) and Spielberger State Anxiety Scale . Assessment s were made at entry and following a 7-day single-blind placebo treatment phase , at the end of which only 51 wished to continue and had sufficient symptoms ( HAS score > 16 or reduction ICI 118,551 ( 50 mg ) , diazepam ( 2 mg ) or placebo thrice daily for 4 weeks . Symptoms were assessed after 2 and 4 weeks in this active treatment phase ( i.e. at weeks 3 and 5 of the study ) . Thirty-five patients completed the study . A statistically significant improvement in HAS score was seen for all patients but there were no significant differences between treatments . Treatments did not differ in their effects on blood pressure or heart rate . β2-Adrenoceptor antagonism does not seem to have important effects on anxiety symptoms in anxiety neurosis",
"This is a double-blind , placebo-controlled , flexible-dose , multicenter , 6-week study comparing regular alprazolam ( compressed tablet , CT ) , given four times per day , and extended release alprazolam ( XR ) , given once in the morning . The aim of the XR preparation is to offer less frequent dosing and to reduce interdose anxiety . Of the intent-to-treat group of 209 patients , 184 completed 3 weeks of medication and were evaluated according to protocol . There was a completer rate for the 6 weeks of 94 % ( CT ) , 97 % ( XR ) , and 87 % ( placebo ) . On global measures , Hamilton Rating Scale for Anxiety , phobia rating , and work disability measures , both active treatment groups were equally effective and significantly more efficacious than the placebo cell on endpoint MANOVA analysis . On analysis of the panic factor with endpoint data , both active treatment groups were equally effective throughout the 6-week trial and significantly more efficacious than the placebo group . Drowsiness occurred more frequently with CT alprazolam ( 86 % of patients ) than with the XR preparation ( 79 % ) or placebo ( 49 % )",
"BACKGROUND Many investigators have reported that panic disorder ( PD ) patients with comorbid major depression ( MD ) have more severe symptoms and a poorer response to treatment than patients with PD alone . It is not known if this is due to a distinct and more serious underlying disorder in these patients or simply a result of the simultaneous presence of the two disorders . METHOD Nondepressed patients presenting for treatment of panic disorder with agoraphobia ( PDA ) were studied before treatment ( N = 180 ) and after 4 weeks of treatment with adinazolam sustained release ( N = 89 ) or placebo ( N = 91 ) . Twenty-nine percent ( N = 53 ) of the patients had a past history of MD . Symptom severity and treatment outcome were compared in patients with primary , secondary , single , recurrent , or no past MD . RESULTS There were no consistent differences in symptom severity or treatment outcome in patients with a past history of primary , secondary , or single episode MD compared with patients with no history of MD . However , a small number of patients with history of recurrent MD exhibited consistently greater symptom severity and poorer response to treatment than patients with no history of MD . CONCLUSION The greater severity and worse outcome of comorbid PD and MD observed in earlier studies are more likely due to the simultaneous presence of the two disorders than to a more serious and enduring underlying disorder . However , our results suggest that recurrent MD may indicate a more serious condition in patients with PDA . This possibility warrants further study",
"The relationship between treating physician 's prognosis and treatment response to active drug or placebo in sample s of 517 anxious and 569 depressed out patients who had participated in 4-week double-blind drug trials was examined . Log-linear analyses employing diagnosis , prognosis , treatment ( active drug or placebo ) , and treatment response were conducted . Anxious patients had been treated with either chlordiazepoxide or placebo , and depressed patients had received either amitriptyline or placebo . Significant differences were found , suggesting that physician prognosis is related to pharmacologically induced symptom relief in anxious but not in depressed patients . In the depressed patient sample , prognosis and improvement were found to be significantly related in placebo but not drug-treated patients",
"Side effects play a significant role in the selection of drugs to be used in panic disorder/agoraphobia whose polyphobic symptomatology often includes a suspiciousness about taking drugs and a fear of undesired side effects which may lead to the refusal of treatment . The safety , side effects and patients ' acceptance of alprazolam and imipramine versus placebo were evaluated in 1168 subjects with panic disorder/agoraphobia who had been enrolled in the second phase of the Upjohn World Wide Panic Study . Side effects that worsened over baseline to a greater extent with alprazolam than with imipramine and placebo were sedation , fatigue/weakness , memory problems , ataxia and slurred speech . In the imipramine group blurred vision , tachycardia/palpitations , insomnia , sleep disturbance , excitement/nervousness , malaise , dizziness/faintness , headache , nausea/vomiting and decrease in appetite were worse than in the other groups . In the placebo group the anxious symptoms were most prominent . The highest level of compliance was shown in the alprazolam-treated group and the lowest in the placebo-treated group . Strong predictors of side effects were not observed . If a side effect profile is known , it will be easier for a clinician to choose the right drug and the appropriate management by taking into account compliance , safety and efficacy in each patient under treatment . Further information about side effects in long-term maintenance treatment would be of great clinical pertinence in ensuring safety and enhancing patients ' quality of life",
"Abstract Objective . Anxiety disorders are frequently under-diagnosed conditions in primary care , although they can be managed effectively by general practitioners . Methods . This paper is a short and practical summary of the World Federation of Biological Psychiatry ( WFSBP ) guidelines for the pharmacological treatment of anxiety disorders , obsessive – compulsive disorder ( OCD ) and posttraumatic stress disorder ( PTSD ) for the treatment in primary care . The recommendations were developed by a task force of 30 international experts in the field and are based on r and omized controlled studies . Results . First-line pharmacological treatments for these disorders are selective serotonin reuptake inhibitors ( for all disorders ) , serotonin-norepinephrine reuptake inhibitors ( for some ) and pregabalin ( for generalized anxiety disorder only ) . A combination of medication and cognitive behavior/exposure therapy was shown to be a clinical ly desired treatment strategy . Conclusions . This short version of an evidence -based guideline may improve treatment of anxiety disorders , OCD , and PTSD in primary care",
"OBJECTIVE To assess the effectiveness of clonazepam , in a fixed dose ( 2 mg/day ) , compared with placebo in the treatment of panic disorder patients . METHOD 24 panic disorder patients with agoraphobia were r and omly selected . The diagnosis was obtained using the structured clinical interview for DSM-IV . All twenty-four subjects were r and omly assigned to either treatment with clonazepam ( 2 mg/day ) or placebo , during 6 weeks . Efficacy assessment s included : change from baseline in the number of panic attacks ; CGI scores for panic disorder ; Hamilton rating scale for anxiety ; and panic associated symptoms scale . RESULTS At the therapeutic endpoint , only one of 9 placebo patients ( 11.1 % ) were free of panic attacks , compared with 8 of 13 ( 61.5 % ) clonazepam patients ( Fisher exact test ; p=0,031 ) . CONCLUSION the results provide evidence for the efficacy of clonazepam in panic disorder patients",
"Psychopharmacological studies usually attempt to eliminate \" nonspecific \" influences on outcome by double-blind design s. In a r and omized , double-blind comparison of alprazolam , imipramine , and placebo , the great majority of panic disorder patients ( N = 59 ) and their physicians were able to rate accurately whether active drug or placebo had been given . Moreover , physicians could distinguish between the two types of active drugs . Inasmuch as correct rating was possible halfway through treatment , concerns about the internal validity of the double-blind strategy arise",
"OBJECTIVE The goals of this study were to assess the antipanic efficacy of a new , sustained-release formulation of alprazolam and to assess the safety and tolerability of once-a-day administration of 1 - 10 mg of sustained-release alprazolam . METHOD One hundred ninety-four patients with diagnosis of agoraphobia with panic attacks or panic disorder with limited phobic avoidance underwent a 1-week placebo washout before being r and omly assigned to groups receiving 8 weeks of double-blind treatment with either sustained-release alprazolam or placebo . RESULTS There was a significant treatment effect favoring sustained-release alprazolam ( highest mean dose = 4.7 mg/day ) across almost all measures of anxiety , panic , and phobic avoidance , despite a significantly higher dropout rate in patients receiving placebo . Eighty-five percent of the patients treated with sustained-release alprazolam , compared with 61 % of the patients given placebo , reported complete blockade of panic attacks by the end of 6 weeks of treatment . Sedation was the most commonly reported adverse effect . Discontinuation of sustained-release alprazolam was associated with moderate but transient levels of distress in 48 % of the patients ; discontinuation of placebo led to distress in only 10 % of the patients . Nonetheless , there was no difference in the proportion of patients who were able to remain off the study drug for at least 2 weeks . CONCLUSIONS These results suggest that sustained-release alprazolam is highly effective in the acute treatment of panic disorder at doses comparable to those in the originally marketed compressed tablet of alprazolam . The medication was well tolerated but showed rebound effects during a rapid drug taper after 6 weeks of treatment",
"A compared , 12 week , placebo controlled study , with fixed dose , outpatient study of patients diagnosed with panic disorder with and without agoraphobia according to ICD-10 , was conducted to evaluate the efficacy and safety of sertraline and alprazolam . The study included 40 patients , divided in two groups . We evaluated number of ICD-10-defined panic attacks , agoraphobia and anticipatory anxiety . All patients were aged 18 year and older and were r and omized to either sertraline or alprazolam . Sertraline applied in fixed doses of 20 mg/day and alprazolam in doses 1 - 1,5 mg/day significantly reduced the frequency of panic attacks in panic disorder patients , reduced symptoms of agoraphobia and anticipatory anxiety",
"This four-week , double-blind , placebo-controlled clinical trial assessed the new benzodiazepine derivative alprazolam ( Xanax ) treatment of moderate to severe anxiety characteristic of anxiety neurosis . Sixty-two out patients participated ; 8 per cent of those taking drug and 52 per cent of those taking placebo discontinued participation due to side effects or lack of efficacy . The mean total daily alprazolam dose was 1.35 mg taken in divided doses . Alprazolam significantly improved scores on five anxiety rating scales -- Hamilton Anxiety Rating Scale , Physician 's Global Impressions , Target Symptoms Record , Self-Rating Symptom Scale , and Patient 's Global Impressions . Alprazolam patients experienced no clinical ly significant changes in vital signs and laboratory values ; they reported drowsiness as the most frequent side effect . We conclude that alprazolam is an effective and safe anxiolytic agent ",
"Abstract This article reports the initial results of a prospect i ve study on the prevalence of psychiatric disorders in the Dutch population aged 18–64 . The objectives and the design of the study are described elsewhere in this issue . A total of 7076 people were interviewed in person in 1996 . The presence of the following disorders was determined by means of the CIDI : mood disorders , anxiety disorders , eating disorders , schizophrenia and other non-affective psychoses , and substance use disorders . Psychiatric disorders were found to be quite common . Some 41.2 % of the adult population under 65 had experienced at least one DSM-III-R disorder in their lifetime , among them 23.3 % within the preceding year . No gender differences were found in overall morbidity . Depression , anxiety , and alcohol abuse and dependence were most prevalent , and there was a high degree of comorbidity between them . The prevalence rate encountered for schizophrenia was lower ( 0.4 % lifetime ) than generally presumed . A comparison with findings from other countries is made . Relevant determinants of psychiatric morbidity were analysed",
"OBJECTIVE The authors test the hypothesis that patient readiness to change predicts outcome in a placebo-controlled medication trial . METHOD Out- patients with panic disorder and agoraphobia completed the Stages of Change ( SOC ) question naire , a measure of readiness to change , before being r and omly assigned either sustained release ( SR ) adinazolam or placebo in a 4 week double-blind trial . RESULTS In the \" intent to treat \" analysis , for the 202 subjects who made at least one visit after baseline , adinazolam SR was significantly more effective than placebo on most major outcome measures . Of the 126 subjects who completed the SOC question naire , regression analyses showed significant correlations between SOC scores and all 5 outcome measures . In a second analysis , cluster membership based on SOC scores was predictive of outcome on 3 of 5 measures . In each statistical analysis , subjects who were not predisposed to change as measured by the SOC were significantly less likely to change . CONCLUSIONS Patient readiness to change was strongly correlated with outcome in a placebo-controlled panic disorder trial with an effective medication . In this study , the SOC category , Precontemplation ( i.e. , those subjects who reported the belief that they had no problem ) were less likely to change compared to those who believed that they had a problem",
"BACKGROUND We report the results from a multicenter , double-blind , r and omized , fixed-dose study design ed to evaluate the relationship between daily dose and efficacy of adinazolam-SR in patients with panic disorder with agoraphobia . METHOD Patients ( N = 315 ) were r and omized to one of four treatment groups ( placebo , N = 83 ; 30-mg group , N = 79 ; 60-mg group , N = 81 ; and 90-mg group , N = 72 ) and then treated twice daily for 4 weeks . All treatment groups were comparable demographically . Primary efficacy measures included total number of panic attacks , global improvement score using the Clinical Global Impressions ( CGI ) scale , phobic anxiety dimension of the Symptom Checklist-90 phobic cluster , overall phobia state using the Phobia Scale , and severity of illness on the CGI . RESULTS The 60- and 90-mg/day adinazolam-SR treatment groups showed superior results when compared with the placebo group at Week 4 while the 30-mg group did not . Treatment with adinazolam-SR was well tolerated , with sedation the only treatment-emergent symptom that occurred more frequently in patients treated with adinazolam-SR than placebo . CONCLUSION These results suggest that adinazolam-SR at doses of 60-mg/day or greater administered twice daily is a safe and effective treatment in selected patients with panic disorder with agoraphobia",
"This study characterizes the pattern of placebo response in depressed panic disorder patients who participated in a r and omized clinical trial . We compared placebo-treated subjects whose panic attacks remitted , with those whose attacks did not remit , and with remitting and nonremitting subjects treated with active medication . Seventy-one subjects who met criteria for panic disorder and for a concurrent depressive diagnosis ( major depression , dysthymia , or depressive disorder not otherwise specified [ NOS ] ) were treated with either imipramine ( n = 36 ) or alprazolam ( n = 35 ) , and 28 patients were treated with placebo . Sixteen placebo-treated and 40 medication-treated patients were panic free at Week 8 . Placebo panic remitters were significantly more ill than active-medication remitters on all measures . In contrast , subjects who achieved panic remission on placebo showed no difference on other clinical measures from active medication nonremitters , and little difference from placebo nonremitters . Results support the need for assessment of all core panic disorder symptoms in determining treatment efficacy and in considerations of response and remission",
"The results of a clinical outcome study ( N = 57 ) comparing behavior therapy directed at panic disorder ( panic control treatment [ PCT ] ) with alprazolam were reported . These conditions were compared with a medication placebo and a waiting-list control group . Patterns of results on measures of panic attacks , generalized anxiety , and global clinical ratings reveal that PCT was significantly more effective than placebo and waiting-list conditions on most measures . The alprazolam group differed significantly from neither PCT nor placebo . The percentage of clients completing the study who were free of panic attacks following PCT was 87 % , compared with 50 % for alprazolam , 36 % for placebo , and 33 % for the waiting-list group . Since alprazolam may work more quickly than PCT but may also interfere with the effects of behavioral treatment , these data suggest a series of studies on the feasibility of integrating these treatments and on the precise patterns and mechanisms of action of various successful treatment approaches to panic disorder",
"BACKGROUND The widespread use of benzodiazepines has led to increasing recognition of their unwanted effects . The efficacy of alprazolam and placebo in panic disorder with agoraphobia , and the side-effect and adverse effect profiles of both drug groups were measured . METHOD In London and Toronto 154 patients who met DSM-III criteria for panic disorder with agoraphobia were r and omised to alprazolam or placebo . Subjects in each drug group also received either exposure or relaxation . Treatment was from weeks 0 to 8 and was then tapered from weeks 8 to 16 . RESULTS Mean alprazolam dose was 5 mg daily . Compared with placebo subjects , alprazolam patients developed more adverse reactions ( 21 % v. 0 % ) of depression , enuresis , disinhibition and aggression ; and more side-effects , particularly sedation , irritability , impaired memory , weight loss and ataxia . Side-effects tended to diminish during treatment but remained significant at week 8 . Despite this , the drop-out rate was low . CONCLUSIONS Alprazolam caused side-effects and adverse effects during treatment but many patients were willing to accept these",
"BACKGROUND Conflicting reports exist in the medical literature regarding the association between industry funding and published research findings . In this study , we examine the association between industry funding and the statistical significance of results in recently published medical and surgical trials . METHODS We examined a consecutive series of 332 r and omized trials published between January 1999 and June 2001 in 8 leading surgical journals and 5 medical journals . Each eligible study was independently review ed for method ological quality using a 21-point index with 5 domains : r and omization , outcomes , eligibility criteria , interventions and statistical issues . Our primary analysis included studies that explicitly identified the primary outcome and reported it as statistically significant . For studies that did not explicitly identify a primary outcome , we defined a \" positive \" study as one with at least 1 statistically significant outcome measure . We used multivariable regression analysis to determine whether there was an association between reported industry funding and trial results , while controlling for study quality and sample size . RESULTS Among the 332 r and omized trials , there were 158 drug trials , 87 surgical trials and 87 trials of other therapies . In 122 ( 37 % ) of the trials , authors declared industry funding . An unadjusted analysis of this sample of trials revealed that industry funding was associated with a statistically significant result in favour of the new industry product ( odds ratio [ OR ] 1.9 , 95 % confidence interval [ CI ] 1.3 - 3.5 ) . The association remained significant after adjustment for study quality and sample size ( adjusted OR 1.8 , 95 % CI 1.1 - 3.0 ) . There was a nonsignificant difference between surgical trials ( OR 8.0 , 95 % CI 1.1 - 53.2 ) and drug trials ( OR 1.6 , 95 % CI 1.1 - 2.8 ) , both of which were likely to have a pro-industry result ( relative OR 5.0 , 95 % CI 0.7 - 37.5 , p = 0.14 ) . INTERPRETATION Industry-funded trials are more likely to be associated with statistically significant pro-industry findings , both in medical trials and surgical interventions",
"Eight males were studied during 27 weeks , including two periods of five weeks during which they received clinical doses of sodium amylobarbitone and benzoctamine . Substitution of placebo for either drug caused raised anxiety and impairment of mental concentration . The drugs reduced restlessness during sleep and reduced paradoxical sleep . By the fifth week of sodium amylobarbitone , although sleep was still less restless in the early night it was more restless than normal in the late night . Blood sample s were taken half-hourly during sleep by indwelling venous catheter . Plasma growth hormone concentration was little affected during drug administration but rose temporarily after withdrawal . There was a reduction of plasma corticosteroid concentration during sleep throughout administration of the drugs and a rebound above normal during the first withdrawal week",
"A cross-national r and omised trial of alprazolam for chronic panic disorder with agoraphobia was run . Compared with previous trials it had three new features : an exposure therapy contrast group , a six-month treatment-free follow-up , and a low rate of early placebo drop-outs ( ' non-evaluables ' ) . The dose of alprazolam was high ( 5 mg/day ) . The 154 patients had eight weeks of : alprazolam and exposure ( combined treatment ) ; or alprazolam and relaxation ( a psychological placebo ) ; or placebo and exposure ; or placebo and relaxation ( double placebo ) . Drug taper was from weeks 8 to 16 . Follow-up was to week 43 . Results were similar at both sites . Treatment integrity was good . All four treatment groups , including double placebo , improved well on panic throughout . On non-panic measures , by the end of treatment , both alprazolam and exposure were effective , but exposure had twice the effect size of alprazolam . During taper and follow-up , gains after alprazolam were lost , while gains after exposure were maintained . Combining alprazolam with exposure marginally enhanced gains during treatment , but impaired improvement thereafter . The new features put previous trails in a fresh light . By the end of treatment , though gains on alprazolam were largely as in previous studies , on phobias and disability they were half those with exposure . Relapse was usual after alprazolam was stopped , whereas gains persisted to six-month follow-up after exposure ceased . Panic improved as much with placebo as with alprazolam or exposure",
"Antidepressants reportedly increase appetite , carbohydrate craving and weight in some patients with depression and panic disorder . This paper presents the results of changes in appetite and weight in patients with panic disorder treated with imipramine , diazepam or placebo in a double-blind prospect i ve study . Forty-four patients with panic disorder were r and omly assigned imipramine , diazepam and placebo . The investigators monitored weight and the patients rated their appetite and cravings during the eight week study . No significant increases in weight or appetite were found in the patients with panic disorder patients",
"In a multicenter placebo-controlled study , the safety , side effects , and patient acceptance of alprazolam for the treatment of panic disorder and agoraphobia were examined . A total of 525 patients meeting DSM-III criteria for agoraphobia with panic attacks or panic disorder were r and omly assigned to receive alprazolam or placebo , which they took for eight weeks . The mean daily dose at the end of the study was 5.7 mg of alprazolam or 7.5 capsules of placebo daily . Potentially serious reactions to alprazolam occurred in ten of 263 subjects who received the drug . These included acute intoxication ( three ) , hepatitis ( two ) , mania ( two ) , amnesia ( one ) , aggressive behavior ( one ) , and depression ( one ) . Treatment-related side effects that were worse in patients taking alprazolam than in those taking placebo included sedation , fatigue , ataxia , slurred speech , and amnesia . Sedation was the most frequent but tended to subside with dose reduction or continued administration of the drug . Patient acceptance of alprazolam , as measured by the rate of completion for study participants , was high . Eighty-four percent of patients receiving active drug completed the study compared with 50 % receiving placebo",
"In a four-week double-blind r and omized trial preceded by a one-week single-blind placebo treatment , the efficacy and the side-effects of suriclone ( 1.50 - 2.25 mg/d ) ( n = 24 ) , lorazepam ( 5.0 - 7.5 mg/d ) ( n = 19 ) and placebo ( n = 21 ) were compared in 64 out patients with a DSM-III diagnosis of generalized anxiety disorder ( n = 56 ) or panic disorder ( n = 8) . Efficacy was measured weekly by means of a global clinical impression scale , the Hamilton Anxiety Rating Scale , the Zung Anxiety Self- Assessment Scale and a target symptom scale . Side-effects were evaluated weekly by an adverse events scale , which recorded the spontaneous complaints and the complaints elicited by an extensive somatic inventory question naire . The three groups showed a statistically significant and clinical ly relevant improvement early on in the treatment : this improvement was maintained during the remaining period . Early on in the treatment there was some indication of a better response , but also of more side-effects , in the suriclone and the lorazepam groups . After four weeks of treatment no difference was found between the three groups either in efficacy or in side-effects . The effect size achieved in the placebo group was not inferior to that of benzodiazepines in general",
"Forty-eight patients with panic disorder completing 8 months of maintenance treatment with alprazolam ( mean dose , 5.2 mg [ n = 27 ] ) , imipramine hydrochloride ( mean dose , 175 mg [ n = 11 ] ) , or placebo ( mean dose , 8.0 pills [ n = 10 ] ) underwent a gradual taper from medication over a 4-week period . A withdrawal syndrome was observed in almost all alprazolam-treated patients but in only a few imipramine- or placebo-treated patients . The clinical worsening of withdrawal symptoms after discontinuation tended to subside over the course of 3 medication-free weeks , but 33 % of alprazolam-treated patients were unable to discontinue their medication regimen successfully . Severity of panic attacks at baseline but not daily alprazolam dose appeared as a significant independent predictor of taper difficulty . Forty-nine percent of the total study population continue to receive drug therapy : 82 % alprazolam and 18 % imipramine . Among patients who received alprazolam during study treatment and at follow-up , the mean daily dose was substantially reduced ( 6.1 vs 1.6 mg [ n = 14 ] ) . At follow-up , after 1 year of naturalistic treatment for panic symptoms and combining 8-month completers and study dropouts , there were no significant differences in remission ( 68 % to 71 % ) or in antipanic medication intake ( 39 % to 56 % ) at follow-up for the three original treatment groups . However , 8-month study completers compared with study dropouts had a significantly higher remission rate ( 85 % vs 55 % )",
"BACKGROUND The purpose of this multicenter , double-blind , placebo-controlled study was to evaluate the efficacy and safety of optimized dosages of clonazepam for the treatment of panic disorder and assess the tolerability of a schedule for gradual discontinuation . METHOD Adult patients with panic disorder with or without agoraphobia ( DSM-III-R criteria ) were r and omly assigned to receive either placebo or clonazepam in individually adjusted doses over 3 weeks to approximate an optimal dosage , which was then maintained for an additional 3 weeks , amounting to a 6-week therapeutic phase . The daily dose range was 0.25 to 4.0 mg administered in 2 divided doses . In the following 7-week discontinuance phase , the doses were tapered gradually to cessation . RESULTS At the therapeutic endpoint , clonazepam ( N = 222 ) proved clinical ly and statistically superior to placebo ( N = 216 ) in change in the number of panic attacks and in Clinical Global Impressions-Severity of Illness ( CGI-S ) and CGI-Change scores , Patient 's Global Impression of Change scores , amount of fear and avoidance associated with phobic symptoms , and duration of anticipatory anxiety . The gradual tapering of clonazepam was not associated with symptoms suggestive of withdrawal syndrome . Although patients taking clonazepam experienced some clinical worsening compared with the status achieved at endpoint , particularly in terms of number of panic attacks , no deterioration was observed using their condition at baseline as point of reference . No overall evidence of rebound was found . All regimens were generally well tolerated . Somnolence was the main adverse event associated with clonazepam therapy . The percentage of patients who reported adverse events was higher in the clonazepam group than in the placebo group , as was the mean number of adverse events per patient . CONCLUSION In this placebo-controlled trial , clonazepam was an efficacious and safe shortterm treatment of the symptoms of panic disorder . Discontinuance during and after slow tapering was well tolerated",
"23 patients with a diagnosis of panic disorder with agoraphobia were r and omly assigned to 8 weeks ' treatment with alprazolam or placebo . They filled in self-ratings before and after treatment and competed on a competitive reaction time task , design ed to measure behavioural aggression , after 8 weeks ' treatment . Patients taking both alprazolam and placebo rated decreased anxiety after 8 weeks ' treatment but those on alprazolam also tended to report less hostility . On the behavioural task , patients on alprazolam behaved more aggressively in response to provocation . This is the first study to confirm clinical reports of benzodiazepine-induced dyscontrol on an objective laboratory measure . It is important that it is followed up in a larger group of patients",
"Pretreatment with imipramine , buspirone , or placebo was compared in 40 patients meeting the Diagnostic and Statistical Manual of Mental Disorders , Revised Third Edition criteria for panic disorder and in patients who were discontinuing long-term benzodiazepine use . The average duration of benzodiazepine use was 75 ± 64 months , and the average benzodiazepine intake expressed as diazepam equivalents was 25.7 ± 19 mg/d . We hypothesized that pretreatment with either imipramine or buspirone , in contrast to pretreatment with placebo , would lead to a significant decrease of symptoms of anxiety and depression before tapering benzodiazepines , thus making the taper process easier to complete . All 3 treatments ( imipramine , buspirone , and placebo ) caused a reduction in anxiety and depression symptoms as measured by changes in the Hamilton Anxiety Rating Scale and Hamilton Depression Rating Scale . Neither discontinuation severity nor taper-free status 12 weeks posttaper differed between the 3 treatment groups",
"In this multicenter , parallel-group , placebo-controlled , fixed-dose study , the efficacy , safety , dosing characteristics , and discontinuation of clonazepam were analyzed in patients with panic disorder . Four hundred thirteen patients were r and omly assigned to receive placebo or one of five fixed daily doses of clonazepam ( 0.5 mg , 1.0 mg , 2.0 mg , 3.0 mg , and 4.0 mg ) . After 3 weeks of dose escalation , the fixed dose was given for 6 weeks ( the dose-maintenance phase ) and then was tapered during a 7-week discontinuance phase . The completion rates for the dose-maintenance phase ranged from 59 to 85 % for the clonazepam groups ( 74 % for the placebo group ) . Efficacy measurements at the end of the dose-maintenance phase indicated clinical improvement in all treatment groups but with a clear differentiation of the four higher doses of clonazepam from the 0.5-mg dose and placebo . The minimum effective dosage , as determined by the Williams ' test , was 1.0 mg daily . Dose-response analysis showed that daily dosages of 1.0 mg and higher were equally efficacious in reducing the number of panic attacks . All treatments were well tolerated . Somnolence and ataxia were reported more often by patients in the 3.0- and 4.0-mg groups ; depression , dizziness , fatigue , and irritability , although not showing dose-relatedness , were reported by more patients taking clonazepam than placebo . During the discontinuance phase , most patients worsened from their condition at the end of the dose-maintenance phase but did not revert to that at baseline . In addition , with the tapering schedule chosen for this study , patients in all treatment groups tolerated the discontinuance of clonazepam . Daily doses of 1.0 to 2.0 mg of clonazepam offered the best balance of therapeutic benefit and tolerability",
"Objective : Several studies have documented that a variety of pharmacological compounds are quite effective in controlling acute symptomatology of panic disorder in the general population . However , there is a paucity of such studies in the management of panic disorder in older adults ( ages 55 and above ) . The purpose of this study was to gather pilot data in older patients with panic disorder to begin to assess the efficacy of two commonly-used antipanic medications , imipramine and alprazolam . Method : Twenty-five ( n = 25 ( 23 females ; 2 males ) ; 18 completers , 7 dropouts ) older panic disorder ( DSM-III-R ) patients ( age range = 55–73 ; mean = 61.24 ) were studied in an eight-week r and omized , parallel-groups , double-blind , placebo-controlled , flexible dose design . Outcome was assessed weekly by global change ratings ( Hamilton Anxiety and Depression Scales ; Physicians ' Global Impression ratings ) and panic diaries . Because of small sample size , we present data descriptively . Results : Subjects in active medication groups evidence d reductions in panic attacks and in levels of overall anxiety and depression . Therapeutic dosages were approximately half those commonly used in younger panic disorder patients . Conclusion : Our data suggest the comparable efficacy of alprazolam and imipramine in the short-term treatment of older adults with panic disorder . There is clearly the need for a larger scale placebo-controlled study , preferably comparing imipramine and /or alprazolam with one of the SSRIs , to substantiate our findings",
"Thirty out- patients suffering from panic disorders associated with agoraphobia were enrolled in a double-blind , controlled trial to compare the effectiveness and tolerability of etizolam and placebo . After a 1-week washout period on placebo , patients were allocated at r and om to receive twice daily doses of either 0.5 mg etizolam or placebo over a period of 4 weeks . Assessment s , made at baseline and after 2 and 4 weeks of treatment , used the Hamilton Rating Scales for Anxiety and for Depression , the Covi Anxiety Scale , and determination of the weekly panic crises frequency . The results showed that etizolam produced significant improvements in chronic anxiety , phobic ideas , associated depressive symptoms and episodic anxiety , and was significantly more effective than placebo . Etizolam treatment was generally well tolerated and was not significantly different from placebo in this respect",
" Fifty-five patients completed a 5-week double-blind study comparing alprazolam , propranolol , and placebo in the treatment of panic disorder and agoraphobia with panic attacks . There was no concomitant behavioral treatment . Patient and therapist rating scales included Sheehan 's Panic and Anxiety Attack Scales , the Marks-Sheehan Phobia Scale , the Hamilton Anxiety Scale , the Hamilton Depression Scale , and the Side Effects Checklist . The results generally support the efficacy of alprazolam , but not propranolol , in the treatment of panic disorder and agoraphobia with panic attacks . The significance of the results are discussed , as well as a number of the unique aspects of our procedures and patient population",
"Twelve studies were undertaken under a common four-week protocol to investigate the efficacy of lorazepam compared with placebo in reducing the severity of moderate to severe anxiety in 264 patients also having significant depressive symptomatology . Analysis of the results indicated that lorazepam gave generally better anxiety relief than placebo ; in the majority of comparisons the differences were substantial enough to be both statistically and clinical ly significant . No data were obtained evidencing significant toxicity in either treatment group",
"In a double-blind controlled study lasting 8 weeks , 50 anxious psychoneurotic out patients with a primary diagnosis of generalized anxiety or panic disorder were r and omly assigned to alprazolam ( n=30 ) , a new benzodiazepine , or placebo ( n=20 ) , after a washout period of 1 week . Alprazolam at dosages between 0.25 and 3 mg/day was found to be significantly better than placebo in the treatment of either disorder . The finding that alprazolam was effective in the treatment of panic disorder is of interest as this diagnostic category is usually treated with tricyclic antidepressants or MAO inhibitors",
"In a double-blind , placebo-controlled study of 200 patients with moderate to moderately severe anxiety we compared the anxiolytic efficacy and safety of alprazolam and lorazepam . Dosing was flexible and ranged from 1 to 4.5 mg/day of alprazolam and from 2 to 9 mg/day of lorazepam . The mean daily dose at the end of the 16 week study was alprazolam 3.3 mg and lorazepam 5.1 mg . Both active drugs were significantly more effective than placebo in relieving the symptoms of anxiety on the Hamilton Anxiety Rating Scale , with a trend toward more improvement in the alprazolam group in the later weeks of the study . Target Symptoms , Physician 's and Patient 's Global Impressions and the Self Rating Symptom Scale indicate that alprazolam and lorazepam were superior to placebo . The major side effects were sedation and drowsiness ; the frequency was similar for alprazolam and lorazepam and twice as high for active drug as placebo . An overall rating of side effect severity was not significantly different among the three groups",
"A double-blind study was carried out in 30 hospital out- patients suffering from moderate to severe neurotic anxiety to compare the efficacy and tolerance of alprazolam and placebo . Patients were allocated at r and om to receive alprazolam , in a dosage of 0.5 to 1 mg 3-times daily , or placebo over a 4-week period . The results of assessment s using the Hamilton Anxiety Rating Scale and global impressions of response to treatment by both physician and patients showed alprazolam to be superior to placebo in the relief of symptoms . Side-effects were infrequent : only 3 of the 15 patients in the alprazolam group reported mild or moderate drowsiness",
"1 . Because imipramine has lowered T4 in uncontrolled studies we examined the effect of imipramine on serum thyroid levels in panic disorder patients in a double-blind placebo and diazepam treatment controlled study . 2 . Treatment with imipramine ( 10 subjects ) was associated with a significant decrease of T4 and FTI and treatment with diazepam ( 8 subject ) was associated with a significant decrease of T4 . However , there was no significant difference across treatment groups . 3 . This finding suggests that previously reported decreases in thyroid hormones during antidepressant therapy may be due to nonspecific effects of treatment rather than to the drug itself",
"BACKGROUND Etizolam is an anxiolytic drug with a pharmacologic profile similar to that of the classic benzodiazepines . Neurochemical research suggests that etizolam may have selectivity for the sub population of Y-aminobutyric acid type A receptors associated with anxiety ( ie , alpha1 , beta2 , gamma2 ) . This property , plus its characterization as a lig and with fewer of the adverse events typical of full agonists ( impaired cognitive function , tolerance , and dependence ) , led to its selection for this study . OBJECTIVES The primary aim of this study was to test for the noninferiority of etizolam 0.5 mg BID versus placebo in affecting cognitive function in patients with mild to moderate anxiety disorder of recent onset ( Anxiety measures and tolerability were also assessed . METHODS Patients between the ages of 18 and 65 years were eligible for enrollment . This double-blind , placebo-controlled study was performed in 5 centers in Italy using a 2-treatment , 3-period crossover design . Patients were r and omized to 3-week sequences of either etizolam-placebo-placebo or placebo-etizolam-etizolam . They were evaluated at 4 scheduled visits ( screening and days 7 , 14 , and 21 ) . Cognitive function was assessed using scores from the Wechsler Adult Intelligence Scale ( WAIS ) Digit Span test ( total forward and backward scores and the time required to perform the test ) . Anxiety was measured using the Hamilton Anxiety Rating Scale ( HAM-A ) and the State-Trait Anxiety Inventory ( STAI ) for screening and to monitor adequacy of therapy . Blood pressure , heart rate , weight , and adverse events were also recorded . RESULTS A total of 77 white patients were enrolled ( mean age , 33.3 years [ range , 22 - 60 years ] ; 62.3 % female ; mean weight , 65.2 kg ) . With a power of 0.80 , the difference between the effects of etizolam and placebo on WAIS Digit Span performance was not significant for total score ( 0.102 [ 90 % CI , -0.130 to 0.335 ] ) or time required for completion ( 0.029 second [ 90 % CI , -0.574 to 0.632 ] ) . Anxiety , as measured using the HAM-A and STAI instruments , did not differ significantly between groups . No significant differences were found between etizolam 0.5 mg BID and placebo for cardiovascular events , weight changes , or adverse events . Mild or moderate somnolence was reported by 7 of 77 patients ( 9.1 % [ 3 patients while receiving etizolam and 4 patients while receiving etizolam and placebo ] ) . CONCLUSIONS No significant differences between etizolam 0.5 mg BID and placebo were found for cognitive function or anxiety measures in these patients with anxiety . Etizolam was well tolerated",
"Discriminant function analyses were applied to data obtained from anxious psychiatric out patients treated with either chlordiazepoxide ( n = 353 ) or placebo ( n = 259 ) and depressed out patients treated with either amitriptyline ( n = 310 ) or placebo ( n = 328 ) , who had participated in controlled drug trials of 4 weeks ’ duration , in an attempt to identify factors associated with complaints of drowsiness made by these patients . Although the magnitude of the relationships between individual predictors and drowsiness was small , several factors emerged which had consistent impact across treatment groups . Predictors of complaints of drowsiness attributed to active drugs arose primarily from demographic attributes probably reflective of life style , and from illness and treatment history . In contrast , predictors of drowsiness attributed to placebo were almost exclusively confined to indices of the severity of several aspects of presenting symptomatology . In particular , more frequent complaints of drug‐induced drowsiness were found among better educated individuals with an illness of long duration . Complaints of placebeinduced drowsiness were more common among patients with more severe emotional ( phobic‐obsessive ) symptomatology and more frequent headaches and among those individuals in whom hypochondriasis was less severe",
"The Cross-National Collaborative Panic Study is a two-phase multinational , multicenter controlled trial for the evaluation of drug treatment of panic disorder and associated agoraphobia . The First Phase compared alprazolam with placebo in a large sample of more than 600 subjects at eight centers -- five in the United States , two in Canada , and one in Australia . The Second Phase compared alprazolam , imipramine hydrochloride , placebo in more than 1100 patients in 14 countries . The scientific background , aims and purpose s , governance , and policies regarding statistical analyses and scientific presentations and publications are review ed as background for the series of individual articles reporting detailed findings from the First Phase",
" Forty-eight patients currently experiencing panic attacks were r and omly assigned to double-blind treatment with alprazolam , diazepam , or placebo . Efficacy was assessed using the Hamilton Rating Scale for Anxiety and a panic attack frequency rating scale . Results indicate that the two active treatments appeared equally effective in reducing both the frequency of panic attacks and the severity of generalized anxiety when compared with placebo . Overall , these data support the use of benzodiazepines in the treatment of panic disorder",
"BACKGROUND Panic disorder ( PD ) is generally regarded as a chronic condition with considerable variation in severity of symptoms . AIMS To describe the long-term outcome of naturalistically treated PD . METHODS Fifty-five out patients with PD , who participated in a placebo-controlled drug trial of the efficacy of alprazolam and imipramine 15 years ago were reassessed with the same instruments used in the original study . RESULTS Complete recovery ( no panic attacks and no longer on medication during the last 10 years ) was seen in 18 % of patients , and an additional 13 % recovered but were still on medication . Fifty-one percent experienced recurrent anxiety attacks whereas 18 % still met diagnostic criteria for PD . The incidence of agoraphobia decreased from 69 % to 20 % . Patients with agoraphobia at admission tended to have a poorer long-term outcome according to daily functioning compared with patients without agoraphobia at admission , although both groups reported improved daily functioning at follow-up . Maintenance medication was common . No benzodiazepine abuse was reported . CONCLUSION PD has a favourable outcome in a substantial proportion of patients . However , the illness is chronic and needs treatment . The short-term treatment given in the drug trial had no influence on the long-term outcome",
"Introduced in the 1950s , antipsychotic agents have been found to improve symptomatology and function in young and middle-aged psychotic schizophrenics . Three decades of research , however , have not made clear these agents ' usefulness in demented elderly patients . A review of placebo-controlled studies suggests a definite but limited role for antipsychotic medication in behaviorally disturbed elderly dementia patients with agitated behavior . Studies also suggest that cognitive function needs careful monitoring when these drugs are prescribed to treat behavioral symptoms of dementia",
"OBJECTIVE The authors ' goal was to evaluate the relationship between plasma concentrations of alprazolam and both treatment response and side effects in patients with panic disorder and agoraphobia . METHOD Ninety-six patients with panic disorder and agoraphobia were treated at three sites in a 6-week , fixed-dose , double-blind , placebo-controlled , dose-response study of 2 mg/day or 6 mg/day of alprazolam . Assessment s were made of panic attacks , avoidance behavior , generalized anxiety , and global response . Blood sample s were collected throughout the study and analyzed for alprazolam and other benzodiazepines . RESULTS Patient compliance with the protocol was judged to be good on the basis of plasma concentrations . According to logistic regression analysis , the relationships between plasma alprazolam concentration and response , as reflected by number of panic attacks reported , phobia ratings , physicians ' and patients ' ratings of global improvement , and the emergence of side effects , were significant . However , there was no significant relationship between plasma alprazolam concentration and the degree of generalized anxiety symptoms . CONCLUSIONS The authors conclude that plasma concentration of alprazolam is related to treatment response , particularly in panic attacks . The alprazolam concentration associated with treatment response or with emergence of a given side effect varied widely among individuals , highlighting the necessity for individualized dose adjustment to obtain optimal treatment response while minimizing side effects",
"In a double-blind , placebo-controlled trial comparing alprazolam and imipramine for panic disorder , serum analysis revealed that a substantial proportion of the patients took explicitly prohibited anxiolytic medication . Excluding these patients changed the results",
"A series of 237 patients with DSM-III-diagnosed panic disorder , or agoraphobia with panic attacks , received alprazolam as part of the placebo-controlled Cross-National Collaborative Panic Study . After a 1-week drug-free period , alprazolam dosage was titrated upward with the objective of reaching 6.0 mg/d in all patients . At week 3 of treatment , alprazolam plasma levels were significantly correlated with daily dosage ( regression slope : 11.7 ng/mL per milligram per day ) but with considerable individual variation . Among patients with spontaneous panic attacks , 70 % of those with plasma alprazolam levels greater than 20 ng/mL achieved complete remission vs 31 % of those with levels less than 20 ng/mL. Situational panic attack remission increased in frequency with increasing plasma levels , but the relationship was not significant . Patient- and physician-rated global improvement and Hamilton Anxiety and Depression Scale score reductions were maximal at 20 to 39 ng/mL , with no further benefit at higher levels . Central nervous system-depressant side effects increased in frequency with higher plasma levels . Between weeks 3 and 8 of treatment , physicians were permitted to adjust dosage ( maximum : 10 mg/d ) to optimize response . At week 8 , the dose-concentration relationship was essentially identical ( regression slope : 10.8 ng/mL per milligram per day ) , but plasma levels were no longer related to efficacy or side effects . Thus , monitoring of plasma alprazolam concentrations may have a clinical ly useful role during short-term treatment of panic disorder",
"To test the reported antipanic efficacy of clonazepam , the authors r and omized 72 subjects with panic disorder to 6 weeks of treatment with either alprazolam , clonazepam , or placebo . Endpoint analysis demonstrated a significant beneficial effect of both active treatments , but not placebo treatment , on the frequency of panic attacks , overall phobia ratings , and the extent of disability . Comparison of the two active treatments revealed no significant differences and no consistent tendency for one agent to be favored over another , although power to detect small differences was limited . Sedation and ataxia were the most common side effects reported , but these effects were mild and transient and did not interfere with treatment outcome . The results of this double-blind , placebo-controlled trial are consistent with previous reports of clonazepam 's antipanic efficacy",
"OBJECTIVE This study was design ed to clarify the nature of the reduced function of the peripheral beta adrenoceptor system observed in panic disorder with agoraphobia . The authors hypothesized that this phenomenon reflected a regulatory and adaptive process . METHODS Lymphocyte beta adrenoreceptor density and affinity , basal lymphocyte cAMP level , and isoproterenol-stimulated cAMP generation were measured in 27 untreated out patients with panic disorder with agoraphobia and 24 healthy comparison subjects . Lymphocyte beta receptor attributes were again assessed in patients after 4 weeks of double-blind treatment with adinazolam ( slow-release form ) or placebo . Panic frequency , agoraphobic symptoms , overall anxiety , and improvement with treatment were assessed with st and ard rating instruments . RESULTS Multivariate statistics revealed significantly lower beta receptor density and isoproterenol-stimulated cAMP generation in patients than in comparison subjects . beta receptor density tended to normalize after adinazolam but not after placebo . Pretreatment beta receptor density was lower in treatment responders than nonresponders . Patients with mild agoraphobia had lower cAMP responsivity than patients with moderate or severe agoraphobia . CONCLUSIONS Decreased function of lymphocyte beta receptors in panic disorder with agoraphobia is expressed as both decreased density and decreased cAMP responsivity . This pattern of changes , and the tendency for receptor density to normalize with treatment , is consistent with an active , regulatory process rather than a structural deficit in the beta receptor system . Preliminary clinical findings suggest that these changes may reflect adaptive processes associated with a favorable clinical course in panic disorder with agoraphobia",
"The Cross-National Collaborative Panic Study , Phase Two , compared alprazolam with imipramine and with placebo in a sample of 1168 r and omly assigned subjects . The study , conducted at 12 centres , assessed clinical change over eight weeks of double-blind drug treatment . Improvement occurred with alprazolam by week 1 and 2 , and with imipramine by week 4 . By the end of week 8 , however , the effects of the two active drugs were similar to each other , and both were superior to placebo for most outcome measures",
"In a multi-center comparison of alprazolam to placebo in the treatment of agoraphobia with panic attacks , the sequence of sustained remission in both treatment groups , was panic attacks before phobias . This may suggest that phobias are secondary to panic attacks in the pathogenesis of the disorder , although other explanations may account for these data and are discussed",
"BACKGROUND Alprazolam has proven efficacy as a treatment for panic disorder , but the place of other benzodiazepines is less well established . METHOD To compare the efficacy and tolerability of diazepam and alprazolam for the disorder , a placebo-controlled , double-blind trial was undertaken in two sites . Two hundred forty-one subjects with panic disorder or agoraphobia with panic attacks were r and omly assigned to flexible doses of diazepam , alprazolam , or placebo for 8 weeks . RESULTS At the end of the trial , over 60 % of subjects taking either diazepam or alprazolam were at least moderately improved compared with less than 30 % of those taking placebo . On all measures of efficacy , subjects taking diazepam and alprazolam showed an equally favorable response . Despite some sedation early in the trial , both drugs were tolerated well . More severely ill subjects responded less well to either benzodiazepine . CONCLUSION The results indicate that diazepam is an effective alternative to alprazolam for the treatment of panic disorder",
"Following promising preliminary evidence , the benzodiazepine-derivative alprazolam was studied in a large , placebo-controlled , eight-week , flexible-dose trial in patients with agoraphobia with panic attacks and panic disorder . Of 526 patients , 481 completed three weeks of treatment ; however , significantly more placebo ( 102/234 ) than alprazolam ( 21/247 ) recipients subsequently dropped out of the trial , primarily citing ineffectiveness ( of placebo ) as the reason . Alprazolam was found to be effective and well tolerated . There were significant alprazolam-placebo differences in improvement for ( 1 ) spontaneous and situational panic attacks , ( 2 ) phobic fears , ( 3 ) avoidance behavior , ( 4 ) anxiety , and ( 5 ) secondary disability , all significant by the end of week 1 . At the primary comparison point ( week 4 ) , 82 % of the patients receiving alprazolam were rated moderately improved or better vs 43 % of the placebo group . At that point , 50 % of the alprazolam recipients vs 28 % of placebo recipients were free of panic attacks",
"Benzodiazepines ( BZs ) produce transient antero grade amnesia when given to normal subjects . The present longitudinal study assessed whether BZs impair memory functions in a clinical ly anxious group . Eighty-two agoraphobics with panic disorder were r and omly allocated to one of four treatment groups result ing from a combination of two drug treatments ( alprazolam or placebo ) and two psychological treatments ( exposure or relaxation ) . Of these , 38 subjects were assessed on a range of objective and subjective indices of memory and mood at three time points : before treatment , after 8 weeks of treatment and again at 24 weeks when patients had been free of medication from 5 - 8 weeks . Alprazolam produced pronounced impairments on a word recall task . At the 24-week medication-free follow-up , alprazolam patients were still impaired on the task compared with placebo patients . Alprazolam did not impair performance on an implicit memory task and did not affect digit span . Differences between psychological treatments emerged mainly in subjective memory effects . Findings are discussed in terms of the specificity of BZ-induced amnesia and differential tolerance to the varying effects of BZs . Implication s are drawn out for the patient 's ability to function optimally in daily life while taking alprazolam",
"Jitteriness appears to be a specific side effect of tricyclic antidepressant treatment in panic disorder patients . In addition , the patients with jitteriness have lower serum iron levels compared to those that do not develop jitteriness ( p = 0.01 )",
"A comparison of safety , and efficiency of Alprazolam , Imipramine , and placebo in the treatment of panic disorder shows that both active drugs are significantly superior to placebo as regards therapeutic effectiveness . On a 77 patient sample , 62 completed an 8-week treatment , and 66 were considered as \" assessable \" for efficiency results after completing a 3-week treatment . Significantly , more placebo-treated patients than either Alprazolam , or Imipramine-treated patients dropped out trial , while the number of panic attacks was significantly reduced in both Alprazolam- , and Imipramine-treated groups . When trial was over , 96 % of patients in Alprazolam group , and 95 % of patients in Imipramine group were free from panic attacks , if compared to 65 % in the placebo group . Generally speaking , drugs were well tolerated , and no serious adverse effects or life-threatening events were observed",
"We hypothesized that the dehydroepi and rosterone-sulfate (DHEA-S)/cortisol ratio , which has been used as an index of adrenocortical function , would be altered in panic disorder patients and would change after treatment . We evaluated 10 male and 14 female out patients meeting DSM-III-R criteria for panic disorder . Of these 24 subjects , 13 were treated with clonazepam , 8 were treated with alprazolam , and 3 were treated with placebo as part of a double-blind study . The DHEA-S/cortisol ratio values in the 24 patients with panic disorder ( mean = 20.5 , SD = 11.6 ) were significantly higher than those of a group of 60 normal controls ( mean = 11.5 , SD = 6.01 ) and were also significantly higher than those of a group of 22 depressed patients ( mean = 10.6 , SD = 6.33 ) . Although there was no significant difference in the pretreatment DHEA-S/cortisol ratio values between male ( mean = 23.6 , SD = 11.8 ) and female ( mean = 18.2 , SD = 11.3 ) panic disorder patients , the effects of treatment on this ratio differed between the two sexes . In fact , in the female patients there was a significant decrease in the DHEA-S/cortisol ratio at the end of the study ( mean = 15.1 , SD = 7.9 ) , while in the male patients there was no significant change in this ratio at the end of the study ( mean = 30.2 , SD = 21.4 ) . No significant differences were noted between pretreatment and posttreatment DHEA-S/cortisol ratio values in patients treated with alprazolam ( n = 8) , in patients treated with clonazepam ( n = 13 ) , or in patients treated with placebo ( n = 3 ) . ( ABSTRACT TRUNCATED AT 250 WORDS",
" Thirty-two out patients with a DSM-III diagnosis of panic disorder or agoraphobia with panic attacks were r and omly assigned to 4 weeks of treatment with clonazepam or placebo , after a 1-week placebo washout period . Twenty-nine patients entered the double-blind phase of the study and were eligible for intent-to-treat analysis . Clonazepam-treated patients experienced significantly fewer panic attacks , and these were of lesser intensity and short duration than those in placebo-treated patients ( p Clonazepam was also superior to placebo with respect to symptoms of anxiety and depression ( p clonazepam at week 4 was 2.2 mg ( st and ard deviation , 0.7 mg ) . There was significant ( p drug concentration in plasma and decrease in the global measure of the severity of panic disorder ( r = 0.68 ) ; similar trends were seen for the decreases in frequency ( r = 0.60 ) and severity ( r = 0.55 ) of panic attacks , but not between concentration in plasma and decline in generalized anxiety . The most common adverse event was drowsiness , which occurred in 9 of 13 clonazepam-treated patients",
"OBJECTIVE The purpose of this study was to compare the effects of discontinuing treatment with intermediate- and long-acting benzodiazepines . METHOD Fifty patients with panic disorder who had taken part in a double-blind treatment study and had responded to alprazolam , diazepam , or placebo for 8 months were asked to stop taking these medications gradually . RESULTS After a relatively rapid dose reduction , the majority of patients relapsed . Rebound anxiety and withdrawal symptoms were identified in a substantial minority of patients . Those who were taking alprazolam showed earlier and more intense rebound anxiety and withdrawal symptoms than did the patients who received diazepam . Both the level of pretreatment anxiety and the drug the patient was taking predicted the level of anxiety when drug treatment was discontinued . CONCLUSIONS The findings indicate that withdrawal phenomena commonly occur after patients stop taking benzodiazepines and that they are more frequent after discontinuation of treatment with shorter-acting drugs",
"Summary The impact of the avoidance behaviour on the psychopharmacological treatment of panic disorder was explored in the Cross National Collaborative Panic Study ( n=1134 patients ) ; in this double blind r and omized trial alprazolam , imipramine and placebo were compared during an 8-week treatment period . Patients with extensive avoidance behaviour ( agoraphobia ) had the most profit from the active drugs . Counter expectancy these specific drug effects were most pronounced in avoidance behaviour . Active drugs ( in particular imipramine ) were especially more effective than placebo if the patients presented with associated avoidance behaviour . The results suggest that agoraphobia defines more a particular type of anxiety disorder overlapping with panic disorder than merely a severe state of panic disorder",
"The pharmacokinetics and pharmacodynamics of the benzodiazepine alprazolam ( 1 mg , administered orally ) were compared between eight patients with panic disorder and eight age- and sex-matched healthy volunteers . Subjects received orally administered placebo and alprazolam in a r and omized , double-blind , single-dose crossover study . The elimination half-life , time of maximum plasma concentration , maximum concentration , volume of distribution , and clearance of alprazolam were similar for both groups . For each cohort , alprazolam treatment ( vs. placebo ) produced significant changes in typical benzodiazepine agonist effects , such as increased sedation and impaired cognitive performance on the digit-symbol substitution test . For the panic disorder group only , there was a significant increase in the subjective rating of\"contented \" and a reduction in the rating of \" easily irritated . \" For the healthy volunteer group , alprazolam produced increases in ratings of \" fatigued \" and \" slowed thinking , \" but also increases in ratings of \" relaxed . \" In each group , alprazolam significantly increased the electroencephalographic ( EEG ) measure of relative beta amplitude ( range , 13 - 30 Hz ) compared with placebo . Concentration-EEG response curves fit a sigmoid E(max ) model , and there was greater sensitivity to EEG effects , as measured by a 28 % reduction in the EC50 value , in the panic disorder group compared with healthy control subjects . After alprazolam treatment , there was increased sensitivity to EEG and mood effects and fewer aversive effects in the panic disorder group compared with healthy subjects . There were no differences in the pharmacodynamic measures of sedation and cognition or differences in pharmacokinetics between the two groups",
"A data -analytic strategy is proposed for identifying the symptom-specific effects of each medication in a clinical trial . The within-group effect size is a st and ardized ratio of the pre-post change relative to the stability of change for each treatment group . Advantages of using this descriptive approach are illustrated by examining antidepressant effects of alprazolam , imipramine , and placebo in a clinical trial for patients meeting criteria for both panic disorder and depression . There was a significant difference between active medication and placebo on the Hamilton Rating Scale for Depression ( HAM-D ) total , but no difference between the anti-depressant effects of the active medications despite their diverse psychopharmacologic properties . Examination of effect sizes for each HAM-D item revealed distinct symptom-specific effects of each active medication in this study sample . Although these descriptive findings can not be used for inferential conclusions , they can be used to guide the design of future trials",
"One of the core problems in clinical research is the detection of early changes in target symptoms that predict future therapeutic outcome . To analyze potential predictors of outcome , data of a multicenter study on patients with panic disorder were used . A total of 1010 patients were r and omly allocated either to alprazolam , imipramine or placebo treatment . Early improvement in the number of spontaneous panic attacks within the first week of treatment predicted outcome exclusively in the alprazolam group . In contrast , placebo responders and nonresponders were differentiated by early changes in anticipatory anxiety intensity . For tricyclic antidepressants such as imipramine an evaluation period of more than one week is required to allow conclusions about outcome",
"Preliminary reports of discontinuation of alprazolam therapy in patients with panic disorder have revealed worsening of symptoms despite gradual withdrawal of medication . In this study , 126 patients with panic disorder and phobic avoidance received either alprazolam or placebo in doses of 2 to 10 mg daily for eight weeks . The medication was tapered over a period of four weeks , and patients were observed for another two weeks after all medication was discontinued . Sixty of the 63 alprazolam-treated patients and 49 of the 63 placebo-treated patients entered the taper and discontinuation study . After improvement in the active treatment period , the alprazolam-treated group had significant relapse between the first and last week of taper . However , during the second postdiscontinuation week , outcome scores were not significantly different from those of the placebo-treated group who did not deteriorate during taper . Twenty-seven percent of the alprazolam-treated group reported a rebound of panic attacks during taper and 13 % reported a rebound of anxiety on the Hamilton Anxiety Scale . No serious or life-threatening withdrawal symptoms were reported , but distinct , transient , mild to moderate withdrawal syndrome occurred in 35 % of the alprazolam-treated group and in none of the placebo-treated group . The coexistence of symptom rebound and a withdrawal syndrome occurred in 10 % of the alprazolam-treated group , but both subsided by the end of the second week without alprazolam . We recommend that patients with panic disorder be treated for a longer period , at least six months , and that medication be tapered over a more prolonged period , at least eight weeks , especially where high doses are employed",
"BACKGROUND Drug therapy of panic disorder , despite the intermittent nature of the panic attack , requires daily administration of antidepressants , which are often not tolerated , or benzodiazepines , which can result in physical dependence and withdrawal . The use of rapidly acting , low-dose intranasal midazolam to prevent incipient panic suggested itself to us as a novel alternative treatment strategy . METHOD We conducted a 6-week double-blind , placebo-controlled , crossover- design pilot study of the safety and efficacy of p.r.n . low-dose intranasal midazolam in five patients diagnosed with DSM-III-R panic disorder . RESULTS One to two drops of midazolam ( approximately 0.25 to 0.5 mg ) was well tolerated and highly effective in preventing incipient panic attacks and in reducing the overall weekly frequency of attacks . CONCLUSION Intermittent intranasal midazolam shows promise as a novel alternative treatment for panic , but a controlled study of its efficacy and safety ( including abuse potential ) must be conducted",
"Agoraphobic and panic disorder patients underwent 1-mg Dexamethasone Suppression Tests ( DST ) before , during , and after an 8-week trial of diazepam , alprazolam , or placebo . Previously described , never-ill controls underwent similar testing . At baseline , 21 of 82 ( 25.6 % ) panic disorder and 5 of 38 ( 13.2 % ) controls were nonsuppressors . This difference grew more marked with multiple testing over a 2-month period ; 18 of 44 ( 40.9 % ) panic disorder patients were nonsuppressors on at least 1 of 3 tests compared with only 5 of 35 ( 14.3 % ) controls ( p = 0.006 ) . DST results were related to severity , but not to the presence or absence , of depressive syndromes . Control for plasma dexamethasone levels left highly significant differences in postdexamethasone cortisol across diagnostic groups . Neither DST results nor plasma dexamethasone levels changed in concert with clinical change , and type of treatment had little differential effect on these measures . Nor did DST results predict subsequent course when active treatment was extended by 6 months . However , DST results during the initial 8 weeks of treatment were strongly related to relapse when medications were tapered , even though this occurred 6 months after the last DST",
"The clinical and biological correlates of gradual alprazolam withdrawal were investigated in 10 patients in a double-blind , placebo-controlled trial . During gradual alprazolam withdrawal , anxiety and plasma cortisol levels were higher than during a postwithdrawal medication-free period"
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Background Falling is the most common accident of daily living and the second most prevalent cause of accidental death in the world . The complex nature of risk factors associated with falling makes those at risk amongst the elderly population difficult to identify . Commonly used clinical tests have limitations when it comes to reliably detecting the risk of falling , but existing laboratory tests , such as force platform measurements , represent one method of overcoming this lack of a test . Despite their widespread use , however , Center of Pressure ( COP ) signal analysis techniques vary and there is currently no consensus on which features should be used diagnostically . Our objective is to identify , through a systematic review and meta- analysis , the COP characteristics of older adults ( ≥ 60 years old ) during quiet bipedal stance which will allow fallers to be distinguished from non-fallers . Methods The systematic review will include both prospect i ve and retrospective articles . Five data bases will be search ed : PubMed , Cochrane CENTRAL , EMBASE , and ScienceDirect . In addition , a search of gray literature will be performed using Google Scholar and Clinical Trials.gov . Search es will be circumscribed to include only older adults ( aged over 60 years ) who underwent a bipedal quiet st and ing measure of their balance and for whom the number of falls was reported . Two authors will independently assess the risk of bias for each included article using a 26-item checklist . Funnel plots will be drawn to attest of possible publication biases for each COP parameters . The results will be synthesized descriptively and a meta- analysis will be undertaken . When trial method ological heterogeneity is too great for pooling of the data into a meta- analysis , evidence strength will be evaluated using best evidence analysis . Discussion Despite the numerous advantages of posturography , the diversity of studies exploring balance in older fallers has led to uncertainty regarding the method ’s ability to reliably identify fall-prone older adults . It is expected that the findings from this systematic review will help clinicians use bipedal quiet st and ing measures as a diagnostic test and allow research ers to explore COP characteristics to create better models for fall prevention care . Systematic review registration PROSPERO | [
"OBJECTIVES To build an item response theory-based computer adaptive test ( CAT ) for balance from 3 traditional , fixed-form balance measures : Berg Balance Scale ( BBS ) , Performance-Oriented Mobility Assessment ( POMA ) , and dynamic gait index ( DGI ) ; and to examine whether the CAT 's psychometric performance exceeded that of individual measures . DESIGN Secondary analysis combining 2 existing data sets . SETTING Community based . PARTICIPANTS Community-dwelling older adults ( N=187 ) who were aged ≥65 years ( mean age , 75.2±6.8y , 69 % women ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES The BBS , POMA , and DGI items were compiled into an initial 38-item bank . The Rasch partial credit model was used for final item bank calibration . CAT simulations were conducted to identify the ideal CAT . CAT score accuracy , reliability , floor and ceiling effects , and validity were examined . Floor and ceiling effects and validity of the CAT and individual measures were compared . RESULTS A 23-item bank met model expectations . A 10-item CAT was selected , showing a very strong association with full item bank scores ( r=.97 ) and good overall reliability ( .78 ) . Reliability was better in low- to midbalance ranges as a result of better item targeting to balance ability when compared with the highest balance ranges . No floor effect was noted . The CAT ceiling effect ( 11.2 % ) was significantly lower than the POMA ( 40.1 % ) and DGI ( 40.3 % ) ceiling effects ( P CAT outperformed individual measures , being the only test to discriminate between fallers and nonfallers ( P=.007 ) , and being the strongest predictor of self-reported function . CONCLUSIONS The balance CAT showed excellent accuracy , good overall reliability , and excellent validity compared with individual measures , being the only measure to discriminate between fallers and nonfallers . Prospect i ve examination , particularly in low-functioning older adults and clinical population s with balance deficits , is recommended . Development of an improved CAT based on an exp and ed item bank containing higher difficulty items is also recommended",
"The objective of this study was to evaluate the sensitivity of posturographic parameters ( PP ) to changes in acquisition setting s. A group of eight young adults underwent a set of typical orthostatic posture trials , and selected PP were then calculated from a set of centre of pressure ( CoP ) displacement time series obtained by applying different cut-off frequencies to the same set of raw data . Four PP out of 11 showed significant changes with respect to cut-off frequency . Statistical mechanics parameters exhibited smaller sensitivity than summary measures . On the basis of the results obtained , a proposal for a st and ard cut-off frequency and a sampling rate value is embodied in the paper together with some suggestions on measurement setting s , with a view to st and ardized use of instrumentation for quantitative analysis in orthostatic posturography",
"Human postural sway , as measured by fluctuations of the center of pressure ( COP ) under the feet of a quietly st and ing individual , can be characterized as a stochastic process . The fluctuation-dissipation theorem ( FDT ) provides a linear relationship between the fluctuations of a quasi-static , stochastic system to the same system 's relaxation to equilibrium following a perturbation . We applied a similar linear relationship , based on the FDT , to the human postural control system to explore whether anterior-posterior ( AP ) fluctuations of the COP during quiet stance can be used to predict the AP response of the postural control system to a weak posteriorly directed mechanical perturbation ( tug or pull at the waist ) . We tested 10 healthy elderly ( mean age of 69yr ) and 10 healthy young ( mean age of 25yr ) adult subjects . We found that this linear relationship was applicable to the postural control system of all 10 young and eight of the 10 elderly adult subjects . These results suggest that it is possible to predict an individual 's dynamic response to a mild perturbation using quiet-stance data , regardless of age . The existence of this FDT-based linear relationship with respect to the human postural control system suggests that , for a given individual , the postural control system may use the same control mechanisms during quiet stance and mild-perturbation conditions , regardless of age",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"A cross-sectional study was performed to investigate the association between fear of falling and postural performance in the elderly . One hundred ambulatory and independent volunteers ( aged 62 - 96 ) were subjected to five types of balance tests : ( a ) spontaneous postural sway , ( b ) induced anterior-posterior sway , ( c ) induced medial-lateral sway , ( d ) one-leg stance , and ( e ) a clinical balance assessment scale . Pseudor and om platform motions were used in the induced-sway tests . The subjects were classified into both \" faller\"/\"nonfaller \" and \" fear\"/\"no-fear \" categories , to allow the influence of fear of falling and falling history to be separated in the analyses . Subjects who expressed a fear of falling were found to exhibit significantly poorer performance in blindfolded spontaneous-sway tests and in eyes-open , one-leg stance tests . The clinical scale was the only balance measure that showed a significant association with retrospective , self-reported falling history . We could not ascertain whether the fear of falling affected balance-test performance in an artifactual manner , or whether the fear and poorer performance were related to a true deterioration in postural control . Until this issue can be resolved , balance-test performance should be interpreted with caution when testing apprehensive individuals . Furthermore , studies of postural control and falling should allow for the potentially confounding influence of fear of falling",
"OBJECTIVES To compare speed and accuracy of graphical data extraction using manual estimation and open source software . STUDY DESIGN AND SETTING Data points from eligible graphs/figures published in r and omized controlled trials ( RCTs ) from 2009 to 2014 were extracted by two authors independently , both by manual estimation and with the Plot Digitizer , open source software . Corresponding authors of each RCT were contacted up to four times via e-mail to obtain exact numbers that were used to create graphs . Accuracy of each method was compared against the source data from which the original graphs were produced . RESULTS Software data extraction was significantly faster , reducing time for extraction for 47 % . Percent agreement between the two raters was 51 % for manual and 53.5 % for software data extraction . Percent agreement between the raters and original data was 66 % vs. 75 % for the first rater and 69 % vs. 73 % for the second rater , for manual and software extraction , respectively . CONCLUSIONS Data extraction from figures should be conducted using software , whereas manual estimation should be avoided . Using software for data extraction of data presented only in figures is faster and enables higher interrater reliability ",
"The cross-sectional associations between clinical variables and biomechanics platform measures of balance ( sway ) were determined in a r and om sample of 50 aged single women living in high rise apartment buildings . A history of falling in the previous year was associated with increased areas of sway . Increased body mass was associated with decreased velocity of sway . Poor near , but not far , visual acuity was associated with increased areas of sway . A postural drop of 10 mmHg or more in diastolic pressure was associated with increased velocity of sway . The associations between these variables and the balance measures persisted after adjustment for age and each other to adjust for potential confounding . Slower h and reaction times and poor hearing were associated with increased areas of sway , but these associations were removed after adjustment for age and near visual acuity . There were no associations between any of the balance measures and postural changes in systolic pressure and heart rate . There were no associations between balance measures and base of support . The observed associations , if causal , can aid in development and testing of effective interventions to improve balance and prevent falls in the elderly"
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BACKGROUND The health effects of conventional yogurt have been investigated for over a century ; however , few systematic review s have been conducted to assess the extent of the health benefits of yogurt . OBJECTIVE The aim of this scoping review was to assess the volume of available evidence on the health effects of conventional yogurt . METHODS The review was guided by a protocol agreed a priori and informed by an extensive literature search conducted in November 2013 . R and omized controlled trials were selected and categorized according to the eligibility criteria established in the protocol . RESULTS 213 studies were identified as relevant to the scoping question . The number of eligible studies identified for each outcome were : bone health ( 14 studies ) , weight management and nutrition related health outcomes ( 81 studies ) , metabolic health ( 6 studies ) ; cardiovascular health ( 57 studies ) ; gastrointestinal health ( 24 studies ) ; cancer ( 39 studies ) ; diabetes ( 13 studies ) , Parkinson 's disease risk ( 3 studies ) , all-cause mortality ( 3 studies ) , skin complaints ( 3 studies ) , respiratory complaints ( 3 studies ) , joint pain/function ( 2 studies ) ; the remaining 8 studies reported a variety of other outcomes . For studies of a similar design and which assessed the same outcomes in similar population groups , we report the potential for the combining of data across studies in systematic review s. CONCLUSIONS This scoping review has revealed the extensive evidence base for many outcomes which could be the focus of systematic review s exploring the health effects of conventional yogurt consumption | [
"Background / Objectives : To investigate the feasibility of Fabuless ( previously called Olibra and Reducal ) as a food ingredient for food intake and appetite reduction , by assessing the effects of food processing on efficacy . Subjects/ Methods : In total , 24 healthy volunteers ( 16 female , 8 male ; age : 18–43 years ; body mass index : 18–37 kg/m2 ) took part in a r and omized , placebo-controlled , double-blinded , cross-over trial . Yoghurt-based meal replacement drinks ( containing processed or unprocessed Fabuless , or a control fat ) were followed by an ad libitum lunch and evening meal ( dinner ) . Key outcome measures were energy intake and self-reported appetite ratings . Results : Compared with control , only unprocessed Fabuless reduced subsequent energy intake , although only during dinner ( P . Self-reported appetite scores did not differ between treatments . Conclusions : Although modest effects of unprocessed Fabuless were seen on food intake , but not on appetite , the ingredient was not robust to common food-manufacturing processes ( thermal and shear processing ) . Cl aims on reduced food intake and appetite relating to this ingredient in food products are , therefore , only valid if functionality has been demonstrated after all relevant processing and storage steps",
"Many epidemiologic studies have reported a positive association between dairy products and prostate cancer . Calcium or saturated fatty acid in dairy products has been suspected as the causative agent . To investigate the association between dairy products , calcium , and saturated fatty acid and prostate cancer in Japan , where both the intake of these items and the incidence of prostate cancer are low , we conducted a population -based prospect i ve study in 43,435 Japanese men ages 45 to 74 years . Participants responded to a vali date d question naire that included 138 food items . During 7.5 years of follow-up , 329 men were newly diagnosed with prostate cancer . Dairy products were associated with a dose-dependent increase in the risk of prostate cancer . The relative risks ( 95 % confidence intervals ) comparing the highest with the lowest quartiles of total dairy products , milk , and yogurt were 1.63 ( 1.14 - 2.32 ) , 1.53 ( 1.07 - 2.19 ) , and 1.52 ( 1.10 - 2.12 ) , respectively . A statistically significant increase in risk was observed for both calcium and saturated fatty acid , but the associations for these were attenuated after controlling for potential confounding factors . Some specific saturated fatty acids increased the risk of prostate cancer in a dose-dependent manner . Relative risks ( 95 % confidence intervals ) on comparison of the highest with the lowest quartiles of myristic acid and palmitic acid were 1.62 ( 1.15 - 2.29 ) and 1.53 ( 1.07 - 2.20 ) , respectively . In conclusion , our results suggest that the intake of dairy products may be associated with an increased risk of prostate cancer . ( Cancer Epidemiol Biomarkers Prev 2008;17(4):930–7",
"Fermented milk products may protect against breast cancer by stimulating immunologic activity . Twenty- five women [ 24.0 ± 0.7 ( SE ) yr ] were assigned r and omly to two groups : control ( n = 12 ) and yogurt treatment ( n = 13 ) . Controls refrained from yogurt products for three months , whereas the yogurt treatment group consumed two cups ( 454 g/day ) of commercially produced yogurt for three consecutive months . Prior yogurt consumption did not exceed 4 - 6 cups/mo , and subjects consumed their usual diet during the study . Three-day diet records and fasting midluteal blood sample s were obtained during subjects ' first , second , and fourth menstrual cycles ( baseline , Month 1 , and Month 3 , respectively ) . Macronutrient intakes differed between groups only for carbohydrate . Calcium intake increased for yogurt consumers during intervention . Lymphocyte proliferation induced by concanavalin A , phytohemagglutinin , and pokeweed mitogen , interleukin 2 production , and cytotoxic T lymphocyte-mediated cytotoxicity was assessed after baseline and Months 1 and 3 for both groups . No significant immune differences between the control and yogurt treatment group were observed for concanavalin A , phytohemagglutinin , pokeweed mitogen , interleukin-2 , or cytotoxicity . In conclusion , three months of yogurt consumption did not enhance ex vivo cell-mediated immune function in young women",
"Objective : The aim of this study was to investigate whether a plant sterol mixture would reduce serum cholesterol when added to low fat dairy products in subjects with hypercholesterolaemia , and to examine the effects of the mixture on the serum plant sterol and fat-soluble vitamin levels . Design : A parallel , double-blind study . Setting : The study was performed in three different locations in Finl and .Subjects : In total , 164 mildly or moderately hypercholesterolaemic subjects participated in the study . Methods : The subjects were r and omly divided into two groups : a plant sterol group and a control group . The subjects consumed the products for 6 weeks after a 3-week run-in period . The targeted plant sterol intake was 2 g/day in the sterol group . Results : During the treatment period , there was a 6.5 % reduction in serum total cholesterol in the sterol group while no change was observed in the control group ( P Serum low-density lipoprotein ( LDL ) cholesterol was reduced by 10.4 % in the sterol group and by 0.6 % in the control group ( P serum high-density lipoprotein ( HDL ) cholesterol or triacylglycerol concentrations . The HDL/LDL cholesterol ratio increased by 16.1 % in the sterol group and by 4.3 % in the control group ( P=0.0001 ) . Serum plant sterol levels increased significantly ( P=0.0001 ) in the sterol group . None of the fat-soluble vitamin levels decreased significantly when changes in serum total cholesterol were taken into account . The hypocholesterolaemic effect of sterol administration was not influenced by apolipoprotein E phenotype . Conclusions : Yoghurt , low-fat hard cheese and low-fat fresh cheese enriched with a plant sterol mixture reduced serum cholesterol in hypercholesterolaemic subjects and no adverse effects were noted in the dietary control of hypercholesterolaemia",
"BACKGROUND & AIMS The study examined the value of n-3 LC-PUFA-enriched yogurt as means of improving cardiovascular health . DESIGN Fifty three mildly hypertriacylglycerolemic subjects ( TAG ≥ 1.7 mmol/L ) participated in a r and omized , placebo-controlled , double-blind , parallel design ed study . The subjects consumed 1 ) control yoghurt ; 2 ) yoghurt enriched with 0.8 g n-3 LC-PUFA/d ; or 3 ) yoghurt enriched with 3 g n-3 LC-PUFA/d for a period of 10 wks . Blood sample s were taken at the beginning and the end of the study period . RESULTS Following daily intake of 3 g n-3 LC-PUFA for 10 weeks , n-3 LC-PUFA levels increased significantly in plasma and red blood cells ( RBC ) with concomitant increase in the EPA-derived mediators ( PGE₃ , 12- , 15- , 18-HEPE ) in plasma whilst cardiovascular risk factors such as HDL , TAG , AA/EPA ratio , and n-3 index were improved ( P decrease of TAG and increase in HDL were associated with the CD36 genotype . CONCLUSION The observed increase of n-3 LC-PUFA in RBC and plasma lipids due to intake of n-3 LC-PUFA enriched yoghurt result ed in a reduction of cardiovascular risk factors and inflammatory mediators showing that daily consumption of n-3 PUFA enriched yoghurt can be an effective way of supplementing the daily diet and improving cardiovascular health ",
"BACKGROUND & OBJECTIVE In protein-energy malnutrition ( PEM ) there is a significant impairment of immunity , both cell-mediated and humoral , which may be reversed with nutritional rehabilitation . With the use of probiotics like curd ( dahi ) and micronutrient-rich leaf protein concentrate ( LPC ) , this immune recovery may be hastened . This study was conducted to assess the impact of supplementation of curd and LPC on nutritional status , and immunity as assessed by anthropometry , haemoglobin , ferritin levels , T- cell sub population and C-reactive protein ( CRP ) , in children suffering from PEM . METHODS Eighty moderate to severely malnourished children ( 1 - 5 yr ) were r and omized to receive either curd or LPC in addition to WHO recommended two-step diet over 15 days . Nutritional , immunological and haematological parameters were measured before and after supplementation and compared within the groups . RESULTS The change in weight , haemoglobin level and CD4:CD8 T-cell sub population was significant in both the groups after supplementation . Response of CRP was blunted in PEM . Serum ferritin decreased significantly after supplementation in both groups . INTERPRETATION & CONCLUSION Curd and LPC when added to diet of malnourished children , may have therapeutic value by accelerating immune recovery . More studies need to be done on a larger sample to confirm these findings",
"BACKGROUND AND PURPOSE High intakes of calcium , potassium , and magnesium have been hypothesized to reduce risks of cardiovascular disease , but only a few prospect i ve studies have examined intakes of these cations in relation to risk of stroke . METHODS In 1980 , 85 764 women in the Nurses ' Health Study cohort , aged 34 to 59 years and free of diagnosed cardiovascular disease and cancer , completed dietary question naires from which we calculated intakes of calcium , potassium , and magnesium . By 1994 , after 1.16 million person-years of follow-up , 690 incident strokes ( 129 subarachnoid hemorrhages , 74 intraparenchymal hemorrhages , 386 ischemic strokes , and 101 strokes of undetermined type ) had been documented . RESULTS Intakes of calcium , potassium , and magnesium were each inversely associated with age- and smoking-adjusted relative risks of ischemic stroke , excluding embolic infa rct ion of nonatherogenic origin ( n=347 ) . Adjustment for other cardiovascular risk factors , including history of hypertension , attenuated these associations , particularly for magnesium intake . In a multivariate analysis , women in the highest quintile of calcium intake had an adjusted relative risk of ischemic stroke of 0.69 ( 95 % CI , 0.50 to 0.95 ; P for trend=0.03 ) compared with those in the lowest quintile ; for potassium intake the corresponding relative risk was 0.72 ( 95 % CI , 0.51 to 1.01 ; P for trend=0.10 ) . Further simultaneous adjustment for calcium and potassium intake suggested an independent association for calcium intake . The association of risk with calcium intake did not appear to be log linear ; the increase in risk was limited to the lowest quintile of intake , and intakes > approximately 600 mg/d did not appear to reduce risk of stroke further . The inverse association with calcium intake was stronger for dairy than for nondairy calcium intake . Intakes of calcium , potassium , and magnesium were not related to risk of other stroke subtypes . CONCLUSIONS Low calcium intake , and perhaps low potassium intake , may contribute to increased risk of ischemic stroke in middle-aged American women . It remains possible that women in the lowest quintile of calcium intake had unknown characteristics that made them susceptible to ischemic stroke",
"Background A large portion of daily intake comes from snacking . One of the increasingly common , healthier snacks includes Greek-style yogurt , which is typically higher in protein than regular yogurt . This study evaluated whether a 160 kcal higher-protein ( HP ) Greek-style yogurt snack improves appetite control , satiety , and delays subsequent eating compared to an isocaloric normal protein ( NP ) regular yogurt in healthy women . This study also identified the factors that predict the onset of eating . Findings Thirty-two healthy women ( age : 27 ± 2y ; BMI : 23.0 ± 0.4 kg/m2 ) completed the acute , r and omized crossover- design study . On separate days , participants came to our facility to consume a st and ardized lunch followed by the consumption of the NP ( 5.0 g protein ) or HP ( 14.0 g protein ) yogurt at 3 h post-lunch . Perceived hunger and fullness were assessed throughout the afternoon until dinner was voluntarily requested ; ad libitum dinner was then provided . Snacking led to reductions in hunger and increases in fullness . No differences in post-snack perceived hunger or fullness were observed between the NP and HP yogurt snacks . Dinner was voluntarily requested at approximately 2:40 ± 0:05 h post-snack with no differences between the HP vs. NP yogurts . Ad libitum dinner intake was not different between the snacks ( NP : 686 ± 33 kcal vs. HP : 709 ± 34 kcal ; p = 0.324 ) . In identifying key factors that predict eating initiation , perceived hunger , fullness , and habitual dinner time accounted for 30 % of the variability of time to dinner request ( r = 0.55 ; p of energy intake regulation",
"Background : Because of its nutrients and anabolic hormones , cow 's milk may promote height growth , which in turn has been related to breast cancer risk . We prospect ively investigated associations between dairy intakes and height growth . Methods : A cohort of 5,101 girls from throughout the United States completed annual surveys ( 1996 - 2001 , 2003 ) , providing height , weight , and past-year diet . At baseline , all were premenarchal , ages 9 years and above , with no serious medical conditions . We studied three outcomes : annual height growth , peak growth velocity , and adult height . Multivariate models estimated the effects of milk , cheese , yogurt , and energy on subsequent growth , adjusted for race/ethnicity , age , prior height , and body mass index . Other models studied fats and proteins . Results : Premenarchal girls who drank > 3 servings per day of milk grew 0.11 in . ( P = 0.02 ) more the following year than girls consuming Yogurt ( + 0.13 in./cup ; P = 0.02 ) , but not cheese or total calories , predicted height growth . In a separate model , dairy protein ( + 0.034 in./10 g ; P height growth . Larger peak velocities were seen among girls reporting , at baseline , more milk ( > 3 glasses per day versus dairy protein ( + 0.039 in./10 g ; P = 0.003 ) . Baseline milk and dairy protein predicted taller adults . Dairy protein was more important than dairy fat , for all outcomes . Nondairy animal protein and vegetable protein were never significant , nor were nondairy animal fat and vegetable fat . Conclusion : Of the foods/nutrients studied , dairy protein had the strongest association with height growth . These findings suggest that a factor in the nonlipid phase of milk , but not protein itself , has growth-promoting action in girls . ( Cancer Epidemiol Biomarkers Prev 2009;18(6):1881–7",
"Low food intake in elderly individuals increases the risk for many nutrition-related acute or chronic illnesses . It is not known whether aging is associated with changes in hunger and satiety , or whether elderly individuals can regulate energy intake in response to manipulations of the energy or nutrient content of foods . Therefore , this study investigated short-term energy regulation in healthy elderly ( n = 16 ; aged 60 - 84 y ) and young ( n = 16 ; aged 18 - 35 y ) men . Participants were given yogurt preloads that varied in energy and macronutrient content ( low-fat , low-energy , 962 kJ ; high-fat , high-energy , 2134 kJ ; high-carbohydrate , high-energy 2134 kJ ) , or no yogurt , followed by a self-selected lunch ( presented 30 min after subjects began to consume the yogurt ) . Energy intake , the percentage of macronutrients consumed in the meals , and subjective sensations of hunger and satiety were analyzed . The elderly men consumed significantly less energy than the young men in the baseline ( no yogurt ) condition . Lower intake was concordant with subjective sensations of satiety ; visual analog data indicated that the older men were less hungry and more full at the start of lunch . Compensation for energy in the preloads was less precise in the elderly than in the young men , in that elderly men consistently overate at the self-selected lunch . Young men consumed + /- 10 % total energy ( lunch + yogurt ) in the yogurt preload conditions compared with their baseline intake ; elderly men overate between 10 % and 30 % in relation to their baseline intake . ( ABSTRACT TRUNCATED AT 250 WORDS",
"In order to determine the effect of milk products on serum cholesterol , triglycerides , and diet , 54 volunteers were studied for varying periods with dietary supplementation of nonpasteurized yogurt , pasteurized yogurt and 2 % butterfat milk . Serum cholesterol was significantly reduced by 5 to 10 % after 1 week of supplementation with either nonpasteurized or pasteurized yogurt ; 2 % butterfat milk reduced serum cholesterol to a smaller and less significant effect . Serum triglycerides were unaffected by the diet and dietary intake studies confirmed that intake of other nutrients remained relatively stable throughout the study . Supplementation of diet with yogurt may have a helpful hypocholesterolemic effect",
"The hypothesis that certain milk products contain a cholesterol-lowering \" milk factor \" was tested in adolescent schoolboys whose diets were complemented with 2 L of skim milk , yoghurt , or full cream milk daily for 3 wk . After a fall in all serum lipids during the precomplementation wk , serum total cholesterol and low-density lipoprotein cholesterol continued to fall on skim milk ; in contrast , it rose for the first 2 wk on yoghurt or full cream milk . These changes correlated with dietary fat and cholesterol intakes . Total cholesterol returned to base-line values during the 3rd wk on yoghurt or full cream milk . High-density lipoprotein cholesterol and percentage high-density lipoprotein/total cholesterol rose transiently in all three groups , with the highest levels being recorded on full cream milk . Serum triglycerides tended to decrease in all groups . No convincing evidence of a milk factor could be found , but skim milk appeared to have a cholesterol-lowering effect at least partly due to its low lipid content",
" Groups of 10 to 13 healthy volunteers were provided with 11 supplements of 2 % butterfat milk ( 2 % milk ) , whole milk , skim milk , yogurt , buttermilk , and sweet acidophilus milk daily for a 3-wk period . Despite increases in caloric intakes on all supplements , no significant increases were found in total , low-density , and high-density lipoprotein cholesterol . A significant weight gain was seen in subjects taking yogurt and acidophilus groups ; these were the only two groups showing significant rises in triglyceride levels . These results in normal volunteers focus attention on the current practice of recommending only skim or 2 % milk for hyperlipidemic individuals ",
"High intake of dietary fat may be key in both the etiology and maintenance of obesity . Because a reduction in the proportion of energy derived from fat will be accompanied by an increase in the proportion of energy derived from carbohydrate , this study compared the effects of these macronutrients on eating behavior in obese and lean individuals . The effects of different amounts of fat and carbohydrate , covertly incorporated into yogurt preloads , on subsequent food intake , hunger , and satiety were assessed . A group of 12 normal-weight men , unconcerned about eating and body weight ( unrestrained ) , accurately compensated for the energy in the preloads regardless of the nutrient composition . Other groups ( n = 12 per group ) , including normal-weight restrained men and normal-weight and obese restrained and unrestrained females , did not show such orderly energy compensation ; joule-for-joule , the high-fat preloads suppressed intake at lunch less than did high-carbohydrate preloads . These results suggest that a relative insensitivity to the satiating effect of fat could be involved in the development and maintenance of obesity",
"This study assessed whether afternoon snacks , varying in protein content , influence appetite-control and eating initiation . Fifteen healthy women ( age : 26 ± 2 y ) r and omly consumed 160 kcal afternoon yogurt snacks containing Low ( LP ) , Moderate ( MP ) , or High ( HP ) protein ( 5,14,24 g protein , respectively ) or had no snack ( NS ) for 3 days . On day 4 , the volunteers came to our facility to consume a st and ardized lunch . The respective snack pattern was completed 3h post-lunch . Perceived sensations were measured every 30 min until dinner was voluntarily requested . An ad libitum dinner was then provided . Snacking , regardless of protein content , led to reduced hunger and increased fullness , which were sustained up to 120 min post-snack vs. NS ( all , p , hunger was lower and fullness was higher throughout post-snack following HP vs. LP ( p the onset of eating vs. NS ( all , p dinner was requested at 124 ± 7 min following NS , 152 ± 7 min with LP , 158 ± 7 min following MP , and 178 ± 7 min post-snack for HP . Between snacks , HP led to the latest request time vs. LP ( p the energy content consumed at dinner was lower following the yogurt snacks vs. NS , the 160 kcal snacks were not fully compensated for at this meal . In conclusion , an afternoon snack of Greek yogurt , containing 24 g protein , led to reduced hunger , increased fullness , and delayed subsequent eating compared to lower protein snacks in healthy women",
"A protective effect of calcium and /or dairy products on colorectal cancer has been reported in epidemiological studies but the findings are considered inconsistent . In particular , it is unclear whether they act at a particular step of the adenoma‐carcinoma sequence . To investigate the effect of dairy product consumption and dietary calcium , vitamin D and phosphorus intake on the adenoma‐carcinoma sequence in the French E3N‐EPIC prospect i ve study . The population for the study of risk factors for adenomas was composed of 516 adenoma cases , including 175 high‐risk adenomas , and of 4,804 polyp‐free subjects confirmed by colonoscopy . The population for the colorectal cancer study was composed of 172 cases and 67,312 cancer‐free subjects . Diet was assessed using a self‐administered question naire completed at baseline . There was a trend of decreasing risk of both adenoma ( ptrend= 0.04 ) and cancer ( ptrend=0.08 ) with increasing calcium intake , with RRs for adenoma and cancer of 0.80 ( IC 95%=0.62–1.03 ) and 0.72 ( 95 % CI=0.47–1.10 ) , respectively , in the fourth quartile compared to the first . A protective effect of dairy products on adenoma ( RRQ4 vs. Q1= 0.80 , 95 % CI=0.62‐1.05 , ptrend= 0.04 ) was observed and of milk consumption on colorectal cancer ( RRQ4vs . Q1= 0.54 , 95 % CI=0.33–0.89 , ptrend= 0.09 ) , although the latter did not reach significance . Phosphorus intake also decreased the risk of adenoma ( RRQ4 vs. Q1=0.70 , 95 % CI=0.54–0.90 , ptrend= 0.005 ) . No vitamin D effect was identified . Our data support the hypothesis that calcium , dairy products and phosphorus exert a protective effect at certain steps of the adenoma‐carcinoma sequence . © 2005 Wiley‐Liss ,",
"Background Prospect i ve studies have consistently reported lower colorectal cancer risks associated with higher intakes of total dairy products , total milk and dietary calcium . However , less is known about whether the inverse associations vary for individual dairy products with differing fat contents . Material s and Methods In the European Prospect i ve Investigation into Cancer and Nutrition ( EPIC ) , we investigated the associations between intakes of total milk and milk subtypes ( whole-fat , semi-skimmed and skimmed ) , yoghurt , cheese , and dietary calcium with colorectal cancer risk amongst 477,122 men and women . Dietary question naires were administered at baseline . Multivariable hazard ratios ( HRs ) and 95 % confidence intervals ( CIs ) were estimated using Cox proportional hazards models , adjusted for relevant confounding variables . Results During the mean 11 years of follow-up , 4,513 incident cases of colorectal cancer occurred . After multivariable adjustments , total milk consumption was inversely associated with colorectal cancer risk ( HR per 200 g/day 0.93 , 95 % CI : 0.89–0.98 ) . Similar inverse associations were observed for whole-fat ( HR per 200 g/day 0.90 , 95 % CI : 0.82–0.99 ) and skimmed milk ( HR per 200 g/day 0.90 , 95 % CI : 0.79–1.02 ) in the multivariable models . Inverse associations were observed for cheese and yoghurt in the categorical models ; although in the linear models , these associations were non-significant . Dietary calcium was inversely associated with colorectal cancer risk ( HR per 200 mg/day 0.95 , 95 % CI : 0.91–0.99 ) ; this association was limited to dairy sources of calcium only ( HR per 200 mg/day 0.95 , 95 % CI : 0.91–0.99 ) , with no association observed for non-dairy calcium sources ( HR per 200 mg/day 1.00 , 95 % CI : 0.81–1.24 ) . Conclusions Our results strengthen the evidence for a possible protective role of dairy products on colorectal cancer risk . The inverse associations we observed did not differ by the fat content of the dairy products considered",
"Background : Hyperlipidemia and obesity are associated with metabolic syndrome and increased risk in developing diabetes and cardiovascular disease . Nutritional supplements , e.g. L-carnitine and polyunsaturated fatty acids ( PUFAs ) , exert lipid-lowering effects . Hence , the hypothesis that dietetic intervention reduces plasma lipid levels and metabolic enzymes in overweight hyperlipidemic subjects was tested . Subjects and Methods : In a prospect i ve placebo-controlled double-blind study in 22 moderately hyperlipidemic obese humans consuming low-fat yoghurt enriched with a combination of low-dose PUFAs , polyphenols and L-carnitine ( PPC ) twice a day for 12 weeks were compared to 20 matching participants ingesting low-fat yoghurt . The effects on plasma lipids and expression of enzymes involved in regulation of fatty acid oxidation in peripheral blood mononuclear cells ( P BMC s ) and HepG2 cells were evaluated . Results : PPC consumption led to significantly reduced plasma free fatty acid ( –29 % ) and triglyceride ( –24 % ) concentrations ( each p PPC application increased significantly peroxisome proliferator-activated receptor α ( PPARα ) mRNA abundances and those of PPARα target genes ( carnitine palmitoyltransferases-1 , CPT1A and CPT1B , carnitine acetyltransferase and organic cation transporter 2 ; each p controls , plasma lipid levels and P BMC gene expression did not change . These findings were substantiated by the results of cell culture experiments in HepG2 cells . Conclusion : Supplementation of PPC had marked lipid-lowering effects and P BMC gene expression profiles seemed to reflect nutrition-related metabolic changes",
"Aim /hypothesisThe aim of this study was to investigate the association between total and types of dairy product intake and risk of developing incident type 2 diabetes , using a food diary . Methods A nested case-cohort within the EPIC-Norfolk Study was examined , including a r and om subcohort ( n = 4,000 ) and cases of incident diabetes ( n = 892 , including 143 cases in the subcohort ) followed-up for 11 years . Diet was assessed using a prospect i ve 7-day food diary . Total dairy intake ( g/day ) was estimated and categorised into high-fat ( ≥3.9 % ) and low-fat ( yoghurt , cheese and milk . Combined fermented dairy product intake ( yoghurt , cheese , sour cream ) was estimated and categorised into high- and low-fat . Prentice-weighted Cox regression HRs were calculated . Results Total dairy , high-fat dairy , milk , cheese and high-fat fermented dairy product intakes were not associated with the development of incident diabetes . Low-fat dairy intake was inversely associated with diabetes in age- and sex-adjusted analyses ( tertile [ T ] 3 vs T1 , HR 0.81 [ 95 % CI 0.66 , 0.98 ] ) , but further adjustment for anthropometric , dietary and diabetes risk factors attenuated this association . In addition , an inverse association was found between diabetes and low-fat fermented dairy product intake ( T3 vs T1 , HR 0.76 [ 95 % CI 0.60 , 0.99 ] ; ptrend = 0.049 ) and specifically with yoghurt intake ( HR 0.72 [ 95 % CI 0.55 , 0.95 ] ; ptrend = 0.017 ) in multivariable adjusted analyses . Conclusions /interpretationGreater low-fat fermented dairy product intake , largely driven by yoghurt intake , was associated with a decreased risk of type 2 diabetes development in prospect i ve analyses . These findings suggest that the consumption of specific dairy types may be beneficial for the prevention of diabetes , highlighting the importance of food group subtypes for public health messages",
"Yogurt helps in treatment and prevention of diarrhea . The aim of this study was to determine the efficacy of consumption of local factory yogurt , which is made with pasteurized milk , on moderately dehydrated hospitalized infants aged 6 - 24 months with acute non-bloody and non-mucoid diarrhea . Eighty moderately dehydrated breast-feeding children aged between 6 - 24 months with acute non-bloody and non-mucoid diarrhea for fewer than four days were included in the study . Patients were r and omly separated into two groups according to their treatment . Infants in the case group received at least 15 ml/kg/day of pasteurized cow milk yogurt orally plus routine hospital treatment . Infants in the control group received routine hospital treatment as in the case group . Weight gains , period of hospitalization , and reduction in diarrhea frequency during hospitalization period of the two groups were compared . Mean duration of hospitalization ( days ) , weight gain , and reduction in diarrhea frequency were 2.7 + /- 0.91 vs 3.1 + /- 0.74 days , 435 + /- 89.20 vs 383 + /- 98.9 g , and 4.30 + /- 1.74 vs 3.60 + /- 1.23 times for case and control groups , respectively . Significant differences were observed in mean hospitalization days ( p=0.035 ) , reduction in diarrhea frequency ( p=0.049 ) and weight gain ( p=0.017 ) . This study recommends universal use of yogurt in acute non-bloody diarrhea",
"BACKGROUND Dairy product intake may be inversely associated with risk of type 2 diabetes , but the evidence is inconclusive for total dairy products and sparse for types of dairy products . OBJECTIVE The objective was to investigate the prospect i ve association of total dairy products and different dairy subtypes with incidence of diabetes in population s with marked variation of intake of these food groups . DESIGN A nested case-cohort within 8 European countries of the European Prospect i ve Investigation into Cancer and Nutrition Study ( n = 340,234 ; 3.99 million person-years of follow-up ) included a r and om subcohort ( n = 16,835 ) and incident diabetes cases ( n = 12,403 ) . Baseline dairy product intake was assessed by using dietary question naires . Country-specific Prentice-weighted Cox regression HRs were calculated and pooled by using a r and om-effects meta- analysis . RESULTS Intake of total dairy products was not associated with diabetes ( HR for the comparison of the highest with the lowest quintile of total dairy products : 1.01 ; 95 % CI : 0.83 , 1.34 ; P-trend = 0.92 ) in an analysis adjusted for age , sex , BMI , diabetes risk factors , education , and dietary factors . Of the dairy subtypes , cheese intake tended to have an inverse association with diabetes ( HR : 0.88 ; 95 % CI : 0.76 , 1.02 ; P-trend = 0.01 ) , and a higher combined intake of fermented dairy products ( cheese , yogurt , and thick fermented milk ) was inversely associated with diabetes ( HR : 0.88 ; 95 % CI : 0.78 , 0.99 ; P-trend = 0.02 ) in adjusted analyses that compared extreme quintiles . CONCLUSIONS This large prospect i ve study found no association between total dairy product intake and diabetes risk . An inverse association of cheese intake and combined fermented dairy product intake with diabetes is suggested , which merits further study",
"Oil-based products enriched with plant stanol esters can lower low-density lipoprotein ( LDL ) cholesterol concentrations by 10 - 14 % . Effectiveness of low-fat products , however , has never been evaluated , although such products fit into a healthy diet . We therefore examined the effects of plant stanol esters emulsified into low-fat yoghurt ( 0.7 % fat ) on fasting concentrations of plasma lipids and lipid-soluble antioxidants , which may also change by plant stanol consumption . Sixty non-hypercholesterolemic subjects first consumed daily three cups ( 3 x 150 ml ) of placebo yoghurt for 3 weeks . For the next 4 weeks , 30 subjects continued with the placebo yoghurt , while the other 30 subjects received three cups of experimental yoghurt . Each cup provided 1 g of plant stanols ( 0.71 g sitostanol plus 0.29 g campestanol ) as its fatty acid ester . LDL cholesterol ( mean+/-S.D. ) increased by 0.06+/-0.21 mmol/l in the placebo group , but decreased by -0.34+/-0.30 mmol/l in the experimental group . The difference in changes between the two groups of 0.40 mmol or 13.7 % was highly significant ( P HDL cholesterol and triacylglycerol concentrations did not change . Total tocopherol levels increased by 1.43 micromol/mmol LDL cholesterol ( 14.0 % , P=0.015 ) . beta-carotene levels , however , decreased by -0.02 micromol/mmol LDL cholesterol ( -14.4 % , P=0.038 ) . Decreases in absolute beta-carotene concentrations were found in all apoB-containing lipoproteins . LDL-cholesterol st and ardised phytofluene levels decreased by 21.4+/-25.7 % ( P plasma carotenoid ( lutein/zeaxanthin , beta-cryptoxanthin , lycopene and alpha-carotene ) levels did not change significantly . We conclude that low-fat yoghurt enriched with plant stanol esters lowers within 1 week LDL cholesterol to the same extent as oil-based products . LDL-cholesterol st and ardised concentrations of tocopherol increased . The observed decrease in beta-carotene levels , as found in many other studies , appears not to be limited to the LDL fraction",
"BACKGROUND AND OBJECTIVE : We have previously demonstrated an antiobesity effect of dietary Ca ; this is largely mediated by Ca suppression of calcitriol levels , result ing in reduced adipocyte intracellular Ca2 + and , consequently , a coordinated increase in lipid utilization and decrease in lipogenesis . Notably , dairy Ca is markedly more effective than other Ca sources . DESIGN : Obese subjects were placed on balanced deficit ( −500 kcal/day ) diets and r and omized to control ( 400–500 mg Ca/day ; n=16 ) or yogurt ( 1100 mg Ca/day ; n=18 ) treatments for 12 weeks . Dietary macronutrients and fiber were held constant at the US average . MEASUREMENTS : Body weight , body fat and fat distribution ( by dual-energy X-ray absorptiometry ) , blood pressure and circulating lipids were measured at baseline and after 12 weeks of intervention . RESULTS : Fat loss was markedly increased on the yogurt diet ( −4.43±0.47 vs −2.75±0.73 kg in yogurt and control groups ; P ) while lean tissue loss was reduced by 31 % on the yogurt diet . Trunk fat loss was augmented by 81 % on the yogurt vs control diet ( P in waist circumference ( −3.99±0.48 vs −0.58±1.04 cm , P the fraction of fat lost from the trunk was higher on the yogurt diet vs control ( P significantly augments fat loss and reduces central adiposity during energy restriction",
"Background Anthropometric characteristics and dietary habits are widely recognized to influence blood pressure . We evaluated their role in a large series of Mediterranean adult women . Methods In Florence , in the European Prospect i ve Investigation into Cancer and Nutrition , we recruited 10 083 women , aged 35–64 years . Detailed information on diet , lifestyle , physical activity , and medical history were collected . Anthropometric indices and systolic and diastolic blood pressures were measured at recruitment using st and ardized procedures . Overall , after excluding those women who reported a clinical diagnosis of hypertension and /or an antihypertensive treatment and those without measurements , 7601 women were available for analyses with an average systolic and diastolic blood pressure value of 123.2 ± 16.0 and 78.7 ± 9.4 mmHg , respectively . Results Multivariate regression models showed that body mass index ( P , potatoes , and wine consumption , were directly associated with both systolic and diastolic values . In contrast , a high consumption of selected foods result ed inversely associated with systolic ( total vegetables , yoghurt , and eggs ) , diastolic ( olive oil ) or both systolic and diastolic values ( leafy vegetables , milk , coffee ) . Analyses performed on nutrients showed a positive association with alcohol and sodium intake , and an inverse one with potassium and micronutrients derived from fruits and vegetables . Conclusion In this large series of women from Tuscany , Central Italy , we confirm the independent influence of anthropometric characteristics on blood pressure . The role of specific foods and nutrients in modulating blood pressure also emerged , suggesting a central role for lifestyle modifications in blood pressure control",
"BACKGROUND : The satiating properties of fat remain poorly understood , particularly with reference to its physicochemical characteristics . OBJECTIVE : To investigate the short-term effects of consumption of yoghurt containing either a novel fat emulsion or normal milk fat , on the energy and macronutrient intakes of non-obese subjects . DESIGN : Two double-blind , placebo-controlled , within-subject crossover studies were conducted three months apart . Twenty-nine ( 15 F , 14 M ) and thirty ( 16 F , 14 M ) subjects participated in Study 1 and Study 2 respectively . In each study , subjects were given in r and om order , 7 days apart , either a 200 g portion of a test ( 5 g of a novel fat emulsion+1 g milk fat ) or control ( 6 g milk fat ) yoghurt at 1300 h. At 4 h post-consumption subjects were given ad libitum access to a range of foods . Amounts of food consumed by individuals were determined by pre- and post-covert weighing of individual serving dishes . RESULTS : Mean energy intakes were significantly lower after the test yoghurt compared with the control yoghurt in Study 1 ( 6.4 vs 7.6 MJ ; P corresponding fat intakes in Study 1 , Study 2 and in the combined studies were all significantly reduced ( P Protein and carbohydrate intakes were also significantly reduced in Study 1 ( P<0.05 ) , Study 2 ( P<0.01 ) , and for the combined studies ( P<0.001 ) . CONCLUSIONS : These results suggest that the physicochemical characteristics of small amounts of dietary fat affect short-term satiety",
"Abstract : The relationship between diet and colorectal cancer mortality was analyzed in a prospect i ve study of 45,181 men and 62,643 women aged 40 - 79 yr enrolled in the Japan Collaborative Cohort Study . Between 1988 and 1990 , subjects completed a self-administered question naire on their sociodemographic characteristics , diet , and other lifestyle habits . During the follow-up period ( average 9.9 yr ) , 284 colon cancer deaths ( 138 men and 146 women ) and 173 rectal cancer deaths ( 116 men and 57 women ) were confirmed . The only significant association of colorectal cancer mortality with vegetable intake was observed between male rectal cancer mortality and green leafy vegetable consumption [ hazard ratio ( HR ) using Cox proportional hazard models = 0.6 ; 95 % confidence interval ( CI ) = 0.3 - 0.9 ; P for trend = 0.02 ] . Yogurt intake was also inversely associated with male rectal cancer mortality ( HR = 0.5 ; 95 % CI = 0.2 - 1.0 ; P for trend = 0.04 ) . Egg consumption was positively associated with male colon cancer mortality ( P for trend = 0.04 ) . Women with high fruit consumption had increased colon cancer mortality ( HR = 1.6 ; 95 % CI = 1.0 - 2.6 ; P for trend = 0.04 ) . It should be noted that this study lacked statistical power due to small sample size and measurement error in the food-frequency question naire . Further investigation is therefore necessary to confirm the association between diet and colorectal cancer , especially by subsites and gender",
"Background / Objectives : High-fat ( HF ) diets of 2 weeks have been shown to accelerate gastric emptying ( GE ) . To date , no studies have shown any alteration in GE following shorter HF diets . The aim of this study was to assess if an HF , high-energy diet of 3 days can adapt gastrointestinal ( GI ) transit , blood lipids and satiety . Subjects/ Methods : Eleven male volunteers participated in a study consisting of three , 3-day interventions each separated by a test day . During the first intervention , volunteers recorded their diet . In the second and third interventions , volunteers repeated their food diary plus either a low-fat yogurt or HF yogurt supplement in r and omized order . Test days involved measurement of GE using the 13C octanoic-acid breath-test , mouth-to-caecum transit time ( MCTT ) using the inulin H2 breath test and satiety using visual analogue scales . Blood sample s for measurement of lipaemia were taken using a venous cannula . Results : MCTT was different between the three test days ( P=0.038 ) , with the shortest MCTT following the HF intervention . GE was shortest following the HF intervention . There were no differences in satiety between the interventions . The HF intervention reduced triglycerides , total cholesterol and low-density lipoprotein cholesterol , and increased high-density lipoprotein cholesterol . Conclusion : This study shows that changes in GI transit owing to an HF diet can occur in a time period as short as 3 days",
"OBJECTIVE Several studies have suggested that dairy food may reduce the risk of obesity and metabolic abnormalities but few have been able to conclusively demonstrate that it reduces the risk of diabetes . The aim of the present analysis was to investigate if dairy food intake independently reduces the risk of diabetes . DESIGN The Australian Diabetes Obesity and Lifestyle Study ( AusDiab ) is a national , population -based , prospect i ve survey conducted over 5 years . Baseline measurements included a 121-item FFQ , anthropometrics and an oral glucose tolerance test . SETTING Forty-two r and omly selected clusters across Australia . SUBJECTS Adults aged ≥25 years who participated in the baseline survey and returned to follow-up 5 years later . RESULTS A total of 5582 participants with complete data were eligible for analysis , 209 of whom had incident diabetes . Compared with men in the first tertile of dairy food intake , men in the third tertile had a significantly reduced risk of developing diabetes after adjustment for age , sex , total energy intake , family history of diabetes , education , physical activity , smoking status , fasting serum TAG and HDL cholesterol , systolic blood pressure , waist circumference and hip circumference ( OR = 0·53 , 95 % CI 0·29 , 0·96 ; P = 0·033 ) . A similar non-significant association was observed in women . CONCLUSIONS Dietary patterns that incorporate high intakes of dairy food may reduce the risk of diabetes among men . Further investigation into the relationship between dairy food intake and diabetes needs to be undertaken to fully underst and the potential mechanism of this observation",
"The aim of the study was to investigate whether galacto-oligosaccharides ( GOS ) relieve constipation in elderly people . The final study population consisted of 14 female subjects , mean age 79.6 ( 69–87 ) years , who suffered from constipation . The study was a double-blind two-period cross-over study . Both study periods lasted 2 weeks . The subjects ingested either 2 control yoghurts or 2 GOS-containing yoghurts daily . The yoghurts were otherwise similar , but the daily dose of GOS ( Elix’or , BWP , Holl and ) from the GOS yoghurt was 9 g. The regular use of laxatives was stopped during the study periods and laxatives were used only when necessary . All the subjects reported the function of their intestines daily in a question naire . The defecation frequency per week ( mean , range ) was higher during the GOS period ( 7.1 , 3–15 ) than during the control period ( 5.9 , 1–14 ) . GOS had no statistically significant effect on the use of laxatives , the consistency of feces or the ease of defecation , although GOS seemed to make defecation easier ( p = 0.07 ) . The adverse gastrointestinal symptoms were similar during both the control and the GOS periods . GOS seem to relieve constipation in most elderly people but the responses differ individually",
"Purpose Studies indicate that milk intake is associated with insulin-like growth factor 1 ( IGF-1 ) concentrations and height in childhood , whether milk and other dairy products promote puberty remains unclear . This study aim ed to investigate influences of pre-pubertal intakes of milk , yogurt and cheese on menarcheal age in Tehranian girls . The associations of total dietary calcium ( Ca ) , magnesium ( Mg ) , and phosphorus ( P ) with menarcheal age were also examined . Methods This prospect i ve study was conducted on 134 pre-pubertal girls , aged 4 - 12 years at baseline , who participated in the Tehran Lipid and Glucose Study ( TLGS ) , and were followed for a median of 6.5 years . Dietary intakes were determined at initiation of the study using two non-consecutive 24-h dietary recalls and the age of menarche was documented during the follow-up . Logistic regression was used to calculate the risk of reaching menarche ≤ 12 years according to pre-pubertal levels of dairy or mineral intakes . Results The risk of earlier menarche was higher in girls with higher intakes of milk [ OR : 2.28 ( 95 % CI : 1.03–5.05 ) ] , Ca [ OR : 3.20 ( 95%CI : 1.39–7.42 ) ] , Mg [ OR : 2.43 ( 95 % CI : 1.12–5.27 ) ] and P [ OR : 3.37 ( 95 % CI : 1.44–7.87 ) after controlling for energy and protein intake , interval between the age at study initiation and the age of menarche , and maternal age at menarche ( Model 1 ) . Girls in the middle tertile of cheese intakes had a lower risk of reaching menarche ≤ 12 years than those in the lowest tertile after controlling for covariates in model 1 . These associations remained significant after further adjustment of BMI Z-score at baseline . The relationship of Ca , Mg , and P with menarche remained after further adjustment for height Z-score at baseline , whereas the association between milk and cheese intakes became non-significant . Conclusions Pre-pubertal intake of milk , but not cheese and yogurt , may hasten age at menarche",
"BACKGROUND Relationships between consumption of dairy products and death from various types of cancer are largely unknown . METHODS Between April 1992 and July 1995 , a baseline survey was conducted for 11,349 residents in 12 communities in Japan , which included collection of demographic data and a self-administered food-frequency question naire inquiring about three dairy products : milk , butter and yogurt . The subjects were followed prospect ively until 2002 . Causes of death were identified using death certificates . Hazard ratios ( HRs ) and their 95 % confidence intervals ( CIs ) for each dairy product were calculated using Cox s proportional hazard models . RESULTS Among eight common cancers , only deaths from hematopoietic neoplasm ( n=14 ) were significantly associated with consumption of butter ( HR=5.11 , 95 % Cl : 1.40 - 18.62 ) , though they exhibited a nearly-significant association with milk consumption ( HR=3.17 , 95 % Cl : 0.99 - 10.17 ) , independent of age and sex . Consumption of milk and butter was significantly associated with non-lymphoma deaths ( n=9 ) when adjusted for age and sex ( HR=9.86 , 95 % Cl : 1.23 - 79.19 for milk : and HR=10.04 , 95 % Cl 2.39 - 42.18 for butter ) . CONCLUSION The frequencies of butter consumption , and probably that of milk , were correlated with death from hematopoietic neoplasm , particularly from non-lymphomas",
"Many studies have been done on the hypocholesterolaemic effect of probiotic yoghurt . The results , however , are not conclusive . The aim of the present study was to test the effect of probiotic and conventional yoghurt on the lipid profile in women . In a r and omised trial , ninety female volunteers aged 19 - 49 years were assigned to three groups . Subjects consumed daily 300 g probiotic yoghurt containing Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 or 300 g conventional yoghurt or no yoghurt for 6 weeks . Fasting blood sample s , 3 d dietary records and anthropometric measurements were collected at baseline ( T1 ) , end of week 3 ( T2 ) and end of week 6 ( T3 ) . Lipid profile parameters were determined by enzymic methods . Results showed no significant difference in lipid profile within any group throughout the study . Comparing mean differences ( T1 - T3 ) among the three groups showed : no difference in TAG and LDL-cholesterol , a decrease in cholesterol in both conventional ( P probiotic yoghurt groups ( P total : HDL-cholesterol ratio for conventional ( P probiotic yoghurt groups ( P HDL-cholesterol in the probiotic yoghurt group ( P lipid profile were observed in both yoghurt groups . Any added effect , therefore , is due to the consumption of fermented milk products",
"The objectives of this study were to determine if high-protein versions of the same food systems show more sensory-specific satiety than lower-protein versions , and to determine the effect of these protein differences on hunger levels following a meal . Subjects ate a high-protein and a low-protein version of a food system ( either strawberry yogurt or a s and wich ) as test meals . The high-protein strawberry yogurt test meal consisted of a serving of strawberry yogurt that contained whey protein isolate ; the low-protein yogurt test meal consisted of a close-to-commercial strawberry yogurt . The high-protein s and wich meal consisted of a ham s and wich ; the low-protein s and wich meal consisted of a bacon s and wich . Subjects tasted small portions of a set of foods ( which included a sample of the test meal ) , and rated their liking of these foods before and after eating a test meal . Sensory-specific satiety occurred for all test meals . The decreases in liking when the high-protein versions of the test meals were eaten were significantly greater than the decreases in liking for the paired low-protein test meals . Higher-protein versions of the test meals also decreased hunger more than the lower-protein versions",
"Background . Given the growing prevalence of overweight and related health consequences , there is increased interest in the search for novel dietary strategies for weight control . A food ingredient , an emulsion based on palm and oat oil ( Fabuless , previously known as Olibra ) , has been associated with short-term reductions of food intake , induction of satiety , alternation in the satiety hormones , as well as long-term effects on weight control . The mechanism by which it can exert these effects is so far unclear , though it has been suggested that the “ ileal break ” may play a role in increasing gastrointestinal transit time . The aim of this study was to investigate the effects of this stable fat emulsion on orocecal transit time in healthy men . Material and methods . In a controlled , double-blind , cross-over- design ed study , 15 healthy men ( aged 20–59 years , body mass index ( BMI ) 22–28 ) , r and omly allocated to two treatments , consumed the stable fat emulsion or a milk fat in yoghurt during two days of investigation , with an interval of 1 week . Orocecal transit time was determined by following blood sulfapyridine levels , which is a metabolite of salazopyrine in the colon . Results . A statistically significant delay in the appearance of sulfapyridine in serum was obtained after active treatment versus control treatment , corresponding to a 45-min longer orocecal transit time due to fat emulsion consumption . Conclusions . This study provides the first evidence to suggest that this stable fat emulsion may affect the ileal brake mechanism by slowing down the gastrointestinal transit time , which might explain the weight control and appetite suppression previously observed in association with this emulsion",
"Dietary regulation of appetite may contribute to the prevention and management of excess body weight . The present study examined the effect of consumption of individual dairy products as snacks on appetite and subsequent ad libitum lunch energy intake . In a r and omised cross-over trial , forty overweight men ( age 32 ( sd 9 ) years ; BMI 27 ( sd 2 ) kg/m2 ) attended four sessions 1 week apart and received three isoenergetic ( 841 kJ ) and isovolumetric ( 410 ml ) servings of dairy snacks or water ( control ) 120 min after breakfast . Appetite profile was determined throughout the morning and ad libitum energy intake was assessed 90 min after the intake of snacks . Concentrations of amino acids , glucose , insulin , ghrelin and peptide tyrosine tyrosine were measured at baseline ( 0 min ) and 80 min after the intake of snacks . Although the results showed that yogurt had the greatest suppressive effect on appetite , this could be confounded by the poor sensory ratings of yogurt . Hunger rating was 8 , 10 and 24 % ( P respectively . Energy intake was 11 , 9 and 12 % ( P the postpr and ial responses of hormones , alanine and isoleucine concentrations were higher after the intake of yogurt than cheese and milk ( P conclusion , all dairy snacks reduced appetite and lunch intake compared with water . Yogurt had the greatest effect on suppressing subjective appetite ratings , but did not affect subsequent food intake compared with milk or cheese",
"OBJECTIVE The aim of the study was to determine the relationship between fermented and unfermented dairy product consumption and Helicobacter pylori seropositivity in a Mexican population . DESIGN Dietary interviews were conducted as part of a population -based case-control study in 2005 . Serum was obtained for each participant to determine H. pylori seropositivity status . Adjusted odds ratios were estimated from multivariate logistic regression models . SETTING Mexico City , Mexico . SUBJECTS A r and om sample of 464 healthy adult residents . RESULTS The overall seroprevalence of H. pylori in the study sample was 75.4 % . In fully adjusted models , compared with those who did not consume yoghurt , there was a protective effect of eating up to one serving per week of yoghurt and more than one serving per week of yoghurt ( odds ratio ( OR ) = 0.57 , 95 % confidence interval ( CI ) 0.35 - 0.94 and OR = 0.45 , 95 % CI 0.24 - 0.86 , respectively ) , with a P for trend of 0.01 . There were no effects for the consumption of unfermented dairy products ( milk and cheese ) . CONCLUSIONS This study suggests that yoghurt consumption may have a protective effect against H. pylori seropositivity . Additional studies are needed to determine whether consumption of yoghurt or other fermented dairy products can prevent or eradicate H. pylori infection",
"Background We evaluated the cholesterol lowering efficacy of low-fat spoonable yoghurt with 1.9 g/d plant stanols as esters on plasma lipid profiles of Turkish subjects with mild to moderate hypercholesterolemia . Methods Using a r and omised , double-blind , placebo-controlled study design , intervention ( n = 35 ) and control ( n = 35 ) groups consumed either 115 g low-fat yoghurt with 1.9 g/d plant stanols as esters or placebo yoghurt , respectively , for 4 weeks . Seventy subjects with untreated mild to moderate hypercholesterolemia ( aged 23 - 65 years ) were recruited . Changes in the lipid profile , including lipoproteins , apolipoproteins , and triglycerides , and anthropometric measurements were monitored at screening , baseline , and at the end of the second , third , and fourth weeks of intervention . The general linear model repeated measures procedure was used to test differences in the repeated continuous variables between study groups . Results Serum total cholesterol ( 4.6 % ) , LDL cholesterol ( 6.3 % ) , and non-HDL cholesterol ( 6.2 % ) concentrations were reduced significantly from baseline in the plant stanol group compared to the control group ( p = 0.007 , p = 0.005 and p = 0.005 , respectively ) . A variation in the response of serum total and LDL cholesterol between the subjects in plant stanol group was obtained . No clinical ly significant change in anthropometrical measurements was observed during the intervention . Conclusions The spoonable low-fat yoghurt with 1.9 g/d plant stanols as esters lowered total , LDL , and non-HDL cholesterol levels in Turkish subjects with mild to moderate hypercholesterolemia . Nevertheless variation in baseline cholesterol levels , genetic predisposition of the subjects and compliance may contribute to a large individual variability",
"Although dairy products have been found to be associated with an elevated risk of prostate cancer , studies investigating the potential effect of Ca are limited , and findings are inconsistent . The objective of the present study was to test the relationship between the risk of prostate cancer and consumption of dairy products and Ca . The analysis included 2776 men from the French SU.VI.MAX ( Supplementation en Vitamines et Minéraux Antioxydants ) prospect i ve study , among whom sixty-nine developed prostate cancer during the follow-up period ( median : 7.7 years ) . Food consumption was assessed at inclusion from repeated 24 h records and nutrient intake was calculated using a food composition table . A higher risk of prostate cancer was observed among subjects with higher dairy product ( relative risk ( RR ; 95 % CI ) , 4th quartile v. 1st : 1.35 ( 1.02 , 1.78 ) , P = 0.04 ) and Ca intake ( RR ( 95 % CI ) , 4th quartile v. 1st : 2.43 ( 1.05 , 5.62 ) , P = 0.04 ) . Nevertheless , we identified a harmful effect of yoghurt consumption upon the risk of prostate cancer ( RR ( 95 % CI ) , increment 125 g/d : 1.61 ( 1.07 , 2.43 ) , P = 0.02 ) independently of the Ca content . Our data support the hypothesis that dairy products have a harmful effect with respect to the risk of prostate cancer , largely related to Ca content . The higher risk of prostate cancer with linear increasing yoghurt consumption seems to be independent of Ca and may be related to some other component",
"Prospect i ve data on the associations between intake of dairy products and its nutrient components with risk of hypertension remain limited . We therefore investigated the associations of intake of dairy products , calcium , and vitamin D with the incidence of hypertension in a prospect i ve cohort of 28 886 US women aged ≥45 years . Intake of dairy products , calcium , and vitamin D at baseline were assessed from semiquantitative food frequency question naires . Incident cases of hypertension ( n=8710 ) were identified from annual follow-up question naires during 10 years of follow-up . After adjusting for major hypertension risk factors , the relative risks of incident hypertension across increasing quintiles of low-fat dairy product intake were 1.00 ( reference ) , 0.98 , 0.97 , 0.95 , and 0.89 ( P for trend : 0.001 ) . The risk of hypertension decreased in the higher quintiles of dietary calcium ( multivariate relative risk in the highest quintile : 0.87 ) and dietary vitamin D ( multivariate relative risk in the highest quintile : 0.95 ) , but did not change with calcium or vitamin D supplements . Adjustment for dietary calcium significantly attenuated the inverse association of low-fat dairy intake with risk of hypertension , whereas adjustment for dietary vitamin D did not change the association . The multivariate relative risks across increasing quintiles of high-fat dairy product intake , in contrast , were 1.00 , 1.02 , 1.01 , 1.00 , and 0.97 ( P for trend : 0.17 ) . Our study found that intakes of low-fat dairy products , calcium , and vitamin D were each inversely associated with risk of hypertension in middle-aged and older women , suggesting their potential roles in the primary prevention of hypertension and cardiovascular complications",
"The present prospect i ve study examined the association between maternal consumption of dairy products , calcium , and vitamin D during pregnancy and the risk of wheeze and eczema in the infants aged 16–24 months . Subjects were 763 Japanese mother – child pairs . Data on maternal intake during pregnancy were assessed with a diet history question naire . Symptoms of wheeze and eczema were based on criteria of the International Study of Asthma and Allergies in Childhood . Higher maternal intake of total dairy products , milk , cheese and calcium during pregnancy was significantly related to a decreased risk of infantile wheeze , but not eczema ( adjusted ORs ( 95 % CI ) between extreme quartiles were 0.45 ( 0.25−0.79 ) , 0.50 ( 0.28−0.87 ) , 0.51 ( 0.31−0.85 ) , and 0.57 ( 0.32−0.99 ) , respectively ) . When maternal vitamin D consumption during pregnancy was categorised into two groups using a cut-off point at the 25th percentile , children whose mothers had consumed ≥4.309 μg·day−1 had a significantly reduced risk of wheeze and eczema ( adjusted ORs ( 95 % CI ) were 0.64 ( 0.43−0.97 ) and 0.63 ( 0.41−0.98 ) , respectively ) . Higher consumption of calcium and dairy foods other than yoghurt during pregnancy may reduce the risk of infantile wheeze . Higher vitamin D intake during pregnancy may be protective against childhood wheeze and eczema ",
"Background Interventions providing foods fortified with multiple micronutrients can be a cost-effective and sustainable strategy to improve micronutrient status and physical growth of school children . We evaluated the effect of micronutrient-fortified yoghurt on the biochemical status of important micronutrients ( iron , zinc , iodine , vitamin A ) as well as growth indicators among school children in Bogra district of Bangladesh . Methods In a double-masked r and omized controlled trial ( RCT ) conducted in 4 primary schools , 1010 children from classes 1–4 ( age 6–9 years ) were r and omly allocated to receive either micronutrient fortified yoghurt ( FY , n = 501 ) or non-fortified yoghurt ( NFY , n = 509 ) . For one year , children were fed with 60 g yoghurt everyday providing 30 % RDA for iron , zinc , iodine and vitamin A. Anthropometric measurements and blood/urine sample s were collected at base- , mid- and end-line . All children ( FY , n = 278 , NFY , n = 293 ) consenting for the end-line blood sample were included in the present analyses . Results Both groups were comparable at baseline for socio-economic status variables , micronutrient status markers and anthropometry measures . Compliance was similar in both the groups . At baseline 53.4 % of the population was anemic ; 2.1 % was iron deficient ( ferritin 8.3 mg/L ) . Children in the FY group showed improvement in Hb ( mean difference : 1.5 ; 95 % CI : 0.4 - 2.5 ; p = 0.006 ) as compared to NFY group . Retinol binding protein ( mean diff : 0.05 ; 95 % CI : 0.002 - 0.09 ; p = 0.04 ) and iodine levels ( mean difference : 39.87 ; 95 % CI : 20.39 - 59.35 ; p better height gain velocity ( mean diff : 0.32 ; 95 % CI : 0.05 - 0.60 ; p = 0.02 ) and height-for-age z-scores ( mean diff : 0.18 ; 95 % CI : 0.02 - 0.33 ; p = 0.03 ) . There was no difference in weight gain velocity , weight-for-age z-scores or Body Mass Index z-scores . Conclusion In the absence of iron deficiency at baseline the impact on iron status would not be expected to be observed and hence can not be evaluated . Improved Hb concentrations in the absence of a change in iron status suggest improved utilization of iron possibly due to vitamin A and zinc availability . Fortification improved height gain without affecting weight gain . Trial registration Clinical Trial.gov :",
"The lipase inhibitor , orlistat , is used in the treatment of obesity and reduces fat absorption by about 30 % . However , the mean weight loss induced by orlistat is less than expected for the degree of fat malabsorption . It was hypothesised that lipase inhibition with orlistat attenuates the suppressive effects of oral fat on subsequent energy intake in normal-weight subjects . Fourteen healthy , lean subjects ( nine males , five females ; aged 25 + /- 1.3 years ) were studied twice , in a double-blind fashion . The subjects received a high-fat yoghurt ' preload ' ( males 400 g ( 2562 kJ ) ; females 300 g ( 1923 kJ ) ) , containing orlistat ( 120 mg ) on one study day ( and no orlistat on the other ' control ' day ) , 30 min before ad libitum access to food and drinks ; energy intake was assessed during the following 8 h. Blood sample s were taken at regular intervals for the measurement of plasma cholecystokinin ( CCK ) . Each subject performed a 3 d faecal fat collection following each study . Energy intake during the day was greater following orlistat ( 10,220 ( SEM 928 ) kJ ) v. control ( 9405 ( SEM 824 ) kJ ) ( P=0.02 ) . On both days plasma CCK increased ( P Plasma CCK 20 min following ingestion of the preload was less after orlistat ( 4.1 ( SEM 0.9 ) pmol/l ) v. control ( 5.3 ( SEM 0.9 ) pmol/l ( P=0.028 ) ; however there was no difference in the area under the curve 0 - 510 min between the two study days . Fat excretion was greater following orlistat ( 1017 ( SEM 168 ) kJ ) v. control ( 484 ( SEM 90 ) kJ ) ( P=0.004 ) . In conclusion , in healthy , lean subjects the acute inhibitory effect of fat on subsequent energy intake is attenuated by orlistat and the increase in energy intake approximates the energy lost due to fat malabsorption",
"PURPOSE To examine the effect of yogurt supplementation pre- and postexercise on changes in body composition in overweight women engaged in a resistance-training program . METHODS Participants ( age = 36.8 ± 4.8 yr ) with a body-mass index of 29.1 ± 2.1 kg/m2 were r and omized to yogurt supplement ( YOG ; n = 15 ) or isoenergetic sucrose beverage ( CONT ; n = 14 ) consumed before and after exercise for 16 wk . Participants were also instructed to reduce energy intake daily ( -1,046 kJ ) during the study . Body composition was assessed by dual-energy X-ray absorptiometry , waist circumference , and sagittal diameter . Strength was measured with 1-repetition maximum . Dietary recalls were obtained by a multipass approach using Nutrition Data System software . Insulin-like growth factor-1 and insulin-like growth-factor-binding protein-3 were measured with ELISA . RESULTS Significant weight losses of 2.6 ± 4.5 kg ( YOG ) and 1.2 ± 2.5 kg ( CONT ) were observed . Total lean weight increased significantly over time in both YOG ( 0.8 ± 1.2 kg ) and CONT ( 1.1 ± 0.9 kg ) . Significant reductions in total fat ( YOG = 3.4 ± 4.1 kg vs. CONT = 2.3 ± 2.4 kg ) were observed over time . Waist circumference , sagittal diameter , and trunk fat decreased significantly over time without group differences . Both groups significantly decreased energy intake while maintaining protein intake . Strength significantly increased over time in both groups . No changes over time or between groups were observed in hormone levels . CONCLUSIONS These data suggest that yogurt supplementation offered no added benefit for increasing lean mass when combined with resistance training and modest energy restriction",
"BACKGROUND The hypothalamus is the central homeostatic control region of the brain and , therefore , highly influenced by nutrients such as glucose and fat . Immediate and prolonged homeostatic effects of glucose ingestion have been well characterized . However , studies that used stimulation with fat have mainly investigated immediate perceptional processes . Besides homeostatic processes , the gustatory cortex , including parts of the insular cortex , is crucial for the processing of food items . OBJECTIVE The aim of this study was to investigate the effect of high- compared with low-fat meals on the hypothalamus and the insular cortex . DESIGN Eleven healthy men participated in a single-blinded , functional MRI study of high- and low-fat meals on 2 measurement days . Cerebral blood flow ( CBF ) was measured before and 30 and 120 min after intake of high- and low-fat yogurts . Hunger was rated and blood sample s were taken before each CBF measurement . RESULTS High-fat yogurt induced a pronounced decrease in CBF in the hypothalamus , and the corresponding CBF change correlated positively with the insulin change . Furthermore , insular activity increased after 120 min in the low-fat condition only . The CBF change in both regions correlated positively in the high-fat condition . CONCLUSIONS The decrease in hypothalamic activity and the interaction with the insular cortex elicited by fat may contribute to an efficient energy homeostasis . Therefore , fat might be a modulator of homeostatic and gustatory brain regions and their interaction . This trial was registered at clinical trials.gov as NCT01516021",
"The association between food groupings and adenocarcinoma of the colon was investigated in a population -based case-control study of men and women ages 30 - 62 years . Colon cancer cases ( 238 men and 186 women ) diagnosed from 1985 to 1989 were identified from the Seattle-Puget Sound Surveillance , Epidemiology , and End Results Registry . Controls ( 224 men and 190 women ) were selected using a r and om digit telephone dialing method . Dietary information was gathered using an 80-item food frequency question naire . Foods were grouped and analyzed by quartile of intake , with adjustment for age and total energy intake . Among women , a reduced risk of colon cancer was associated with a high intake of fruits and vegetables [ adjusted odds ratio ( OR ) for highest versus lowest quartile , 0.48 ; 95 % confidence interval ( CI ) , 0.26 - 0.86 ; P for trend , P = 0.02 ] . Inverse associations were also observed for the consumption of total ( hot and cold ) cereals ( OR , 0.47 ; 95 % CI , 0.25 - 0.91 ; P = 0.05 ) , dairy products ( OR , 0.40 ; 95 % CI , 0.21 - 0.79 ; P = 0.05 ) , and water ( OR for > 5 glasses/day versus men , colon cancer risk was inversely associated with the intake of breads and cereals ( OR , 0.43 ; 95 % CI , 0.22 - 0.82 ; P = 0.02 ) and hot cereal ( OR for weekly versus never eating , 0.53 ; 95 % CI , 0.32 - 0.87 ; P = 0.01 ) . Water consumption was marginally associated with a decreased colon cancer risk among men as well ( OR for > 4 glasses/day versus Total meat consumption was associated with an increased risk of distal colon cancer among men ( OR , 2.20 ; 95 % CI , 1.08 - 4.48 ; P = 0.01 ) . These results were not confounded by body mass index or other measured health behaviors . Results of this research support previous findings which associate intake of fruits , vegetables , grains , and dairy products with reduced colon cancer risk , and meat intake with an increased colon cancer risk . This study also reports a new finding of a possible inverse association of water consumption ( glasses of plain water per day ) with colon cancer risk",
"Objective : To examine the effects of lecithin on serum lipoprotein , plasma fibrinogen and macro molecular protein complex ( MPC ) levels . Subjects and study design : Twenty free living hyperlipidaemic men participated in this double-blind study which controlled for possible indirect effects . The subjects were r and omly assigned to one of three treatments : frozen yoghurt or frozen yoghurt with 20 g soya bean lecithin or frozen yoghurt with 17 g sunflower oil . Sunflower oil was used to control for the increased energy and linoleic acid intake from lecithin . Yoghurt served as the ‘ vehicle ’ for the lecithin and sunflower oil and yoghurt alone was given to one group to control for possible effects due to the yoghurt ‘ vehicle ’ , as well as other environmental influences . Variables were measured with st and ard methods twice at baseline and after 2 and 4 weeks of treatment . Results : Plasma linoleic acid levels increased significantly with lecithin and sunflower oil treatments indicating that compliance to the treatments were obtained . Lecithin treatment did not have significant effects on serum total cholesterol , triglyceride , high density lipoprotein cholesterol , low density lipoprotein cholesterol , apolipoprotein A , apolipoprotein B or lipoprotein ( a ) levels . Plasma fibrinogen and MPC levels were also not affected by lecithin therapy . Sunflower oil treatment result ed in significant increased body weight , serum TC and decreased MPC levels . Conclusion : Lecithin treatment had no independent effects on serum lipoprotein , plasma fibrinogen or MPC levels in hyperlipidaemic men . Sponsorship : Drybean Producers Organisation ( South Africa ) ; Chempure cc ( South Africa ) ; SACCA , Pty . Ltd. ( South Africa )",
"Background / Objectives : Dairy foods contain various nutrients that may affect health . We investigated whether intake of dairy products or related nutrients is associated with mortality due to cardiovascular disease ( CVD ) , cancer and all causes . Subjects/ Methods : We carried out a 16-year prospect i ve study among a community-based sample of 1529 adult Australians aged 25–78 years at baseline . Habitual intakes of dairy products ( total , high/low-fat dairy , milk , yoghurt and full-fat cheese ) , calcium and vitamin D were estimated as mean reported intake using vali date d food frequency question naires ( FFQs ) self-administered in 1992 , 1994 and 1996 . National Death Index data were used to ascertain mortality and cause of death between 1992 and 2007 . Hazard ratios ( HRs ) were calculated using Cox regression analysis . Results : During an average follow-up time of 14.4 years , 177 participants died , including 61 deaths due to CVD and 58 deaths due to cancer . There was no consistent and significant association between total dairy intake and total or cause-specific mortality . However , compared with those with the lowest intake of full-fat dairy , participants with the highest intake ( median intake 339 g/day ) had reduced death due to CVD ( HR : 0.31 ; 95 % confidence interval ( CI ) : 0.12–0.79 ; P for trend=0.04 ) after adjustment for calcium intake and other confounders . Intakes of low-fat dairy , specific dairy foods , calcium and vitamin D showed no consistent associations . Conclusions : Overall intake of dairy products was not associated with mortality . A possible beneficial association between intake of full-fat dairy and cardiovascular mortality needs further assessment and confirmation",
"BACKGROUND Probiotic capsules have been shown to reduce the incidence of antibiotic-associated diarrhoea in a number of setting s. If probiotic yogurt were equally efficacious then it would provide a simple and cost-effective means of preventing antibiotic-associated diarrhoea . AIM To investigate whether eating live bio yogurt at the time of taking oral antibiotics can prevent antibiotic-associated diarrhoea . DESIGN OF STUDY This study was a three-arm ( bio yogurt , commercial yogurt , no yogurt ) r and omised controlled trial with double blinding between the two yogurt arms . SETTING A single primary care general practice surgery in Hingham , Norfolk . The study population included all ages except babies . METHOD Patients aged over 1 year who required a 1-week course of antibiotics were included in the study . There was complete follow up for 369 patients . The intervention was the consumption of 150 ml of live strawberry-flavoured yogurt for 12 days , starting on the first day of taking the antibiotic . Diarrhoea was defined as ' three or more loose stools per day over at least 2 consecutive days ' within 12 days of starting the antibiotics . RESULTS Of the 120 patients in the no-yogurt group , 17 ( 14 % , 95 % confidence interval [ CI ] = 9.0 to 21.5 ) developed diarrhoea . Of the 118 given commercial yogurt , 13 ( 11 % , 95 % CI = 6.6 to 17.9 ) developed diarrhoea ; nine of the 131 patients ( 7 % ; 95 % CI = 3.7 to 12.5 ) given bio yogurt developed diarrhoea ( P = 0.17 ) . CONCLUSION Overall , this study failed to demonstrate that yogurt has any effect on antibiotic-associated diarrhoea",
"BACKGROUND Despite the contribution of dairy foods to total dietary saturated fat intake , available data indicate that dairy consumption may lower the risk of cardiovascular disease . OBJECTIVE The objective of this study was to investigate the relation between consumption of milk , cheese , and yogurt and common carotid artery intima-media thickness ( CCA-IMT ) in a cohort of elderly women . DESIGN Dairy consumption was assessed with a vali date d food-frequency question naire in 1080 participants r and omly selected from ambulant white women aged > 70 y living in Perth , Western Australia . CCA-IMT was assessed by using B-mode carotid ultrasound 3 y later . Cardiovascular disease risk factors , including serum lipids and blood pressure , were assessed at baseline . RESULTS Total dairy product , milk , and cheese consumption was not associated with CCA-IMT ( P > 0.05 ) , whereas yogurt consumption was negatively associated with CCA-IMT ( unadjusted st and ardized β = -0.081 , P = 0.008 ; baseline risk factor-adjusted st and ardized β = -0.075 , P = 0.015 ) . Participants who consumed > 100 g yogurt/d had a significantly lower CCA-IMT than did participants with lower consumption ( unadjusted = -0.024 mm , P = 0.002 ) . This relation remained significant after adjustment for baseline , dietary , and lifestyle risk factors ( multivariable analysis = -0.023 mm , P = 0.003 ) . CONCLUSION Increased consumption of yogurt , but not of other dairy products , is associated with a lower CCA-IMT , independent of other risk factors",
"Objective : To assess weight maintenance after weight loss by consumption of yoghurt with a novel fat emulsion ( Olibra ) including effects on body composition , resting energy expenditure ( REE ) , fat oxidation , hunger feelings and satiety hormones . Design : A r and omized , placebo-controlled , double-blind , parallel design . A 6-week weight loss period ( 2.1 MJ/day ) was followed by 18 weeks weight maintenance with test ( Olibra ) or placebo yoghurt . Subjects : Fifty overweight women ( age : 18–58 years , body mass index ( BMI ) 25–32 kg/m2 ) . Measurements : In weeks 1 , 7 and 25 , a satiety test with question naires and blood sample s for analysis of satiety hormones . In weeks 2 , 8 and 26 , REE , body weight and body composition . Results : During weight maintenance after significant body weight reduction , there was no significant increase in body weight in the test group ( 1.1±3.4 kg ) ; the placebo group did gain weight ( 3.0±3.1 kg , P hungry 4 h after yoghurt consumption in week 25 ( P increased glucagon like peptide-1 values 180 min after yoghurt consumption ( week 25 vs week 1 , P Measured REE as a function of fat-free mass ( FFM ) was significantly higher than predicted REE ( P group . Fat mass ( FM ) was significantly more decreased in the test group ( 6.5±4.1 kg ) compared to the placebo group ( 4.1±3.6 kg ) ( week 26 vs week 2 , P Consumption of Olibra yoghurt improved weight maintenance compared to placebo , which can be explained by the relatively higher REE as a function of FFM , relatively higher decrease in FM and the relatively lower increase in hunger ",
"Background The aim of this study was to compare the effect of infant formula and the same formula subjected to microbial fermentation ( yogurt ) on the duration of diarrhea in young children with acute watery diarrhea , with or without reducing substances in stools . Methods One hundred twelve well-nourished children , aged 3 to 24 months , who were admitted to the hospital with acute watery diarrhea were included in a r and omized trial . After appropriate rehydration , they were fed either an infant formula ( group M , n = 56 ) or the same formula fermented with Lactobacillus bulgaricus and Streptococcus thermophilus ( group Y , n = 56 ) . The two feedings were comparable in lactose concentration ( 40 to 42 g/L ) , pH 4.5 , flavor , and texture . The groups were subdivided into those with or without reducing sugars in stools at presentation . The presence of reducing sugars in stool was used as a marker of carbohydrate malabsorption . Results Group M and group Y had comparable clinical characteristics at admission , including the number of patients with reducing sugars in stools ( n = 31 in group M and 27 in group Y ) . The success rate ( cessation of diarrhea and appropriate weight gain 7 days after enrollment into the study ) was similar in both groups ( 82 % in group M vs. 84 % group Y ) . Clinical failure was 3.6 % in both groups . The percentage of patients withdrawn from the study for medical reasons ( 5.4 % in group M vs. 7.1 % in group Y ) or withdrawn at the parents ’ request ( 8.9 % in group M vs. 5.4 % in group Y ) was similar . Duration of diarrhea and number of stools were significantly less in group Y compared with group M. Forty-eight hours after inclusion , diarrhea was still present in 62 % of group M versus in 35 % of group Y ( P rate of success ( 82 % ) was similar in groups M and Y , but the duration of diarrhea and number of stools per day were significantly decreased in group Y. Forty-height hours after inclusion , diarrhea was still present in 75 % of group M patients and in 20 % of group Y patients who had reducing substances in the stool . Conclusion Young children with acute watery diarrhea , without malnutrition or associated disease , can be equally well treated with feeding of either infant formula or yogurt . Yogurt feeding is associated with a clinical ly relevant decrease in stool frequency and duration of diarrhea in children who have reducing sugars in stools",
"The objective of the study was to confirm the satiety/energy intake effect of a novel fat emulsion ( Olibra ) versus placebo in the short term . A r and omized , double-blind , placebo-controlled , crossover design was used . 41 subjects participated in the study ( n=21 : junior-normal weight : age 23.7+/-2.8 years ; BMI : 22.0+/-1.6 kg/m(2 ) ; n = 20 : senior-overweight : age 43.6+/-4.9 years ; BMI : 27.7+/-1.6 kg/m(2 ) ) . An energy intake and satiety test ( with question naires ) took place on 2 occasions , with placebo or test yoghurt as breakfast . In the junior-normal weight subjects , consumption of test yoghurt reduced hunger and desire to eat during the morning ( area under curve , p time elapsed between consumption of the yoghurt and the point at which hunger scores returned to baseline ; 234+/-79 min in the test condition compared to 174+/-58 min in the placebo condition ( p appetite scores between the test and placebo yoghurt were seen for the senior-overweight subjects . No effect on energy intake was seen in the total group , in the junior-normal weight and senior-overweight subjects . In conclusion , the Olibra emulsion exerted a suppressive effect on the area under the curve of appetite ratings over 3 h in normal weight women aged 18 to 30 years . The Olibra emulsion did not affect subsequent energy intake in either group",
"Aims /hypothesisCalcium and vitamin D have been implicated in the development of type 2 diabetes , but epidemiological evidence is limited . We examined prospect ively the relation of calcium and vitamin D intake to type 2 diabetes risk in a Japanese cohort . Methods Participants were 59,796 middle-aged and older men and women , who participated in the Japan Public Health Center-based Prospect i ve Study and had no history of type 2 diabetes or other serious diseases . Dietary intake of calcium and vitamin D were estimated using a vali date d food frequency question naire . Logistic regression was used to assess the association between intake of these nutrients and self-reported newly diagnosed type 2 diabetes . Results During a 5 year follow-up , 1,114 cases of type 2 diabetes were documented . Overall , calcium intake was not associated with a significantly lower risk of type 2 diabetes ; the multivariable odds ratio for the highest vs lowest quartiles was 0.93 ( 95 % CI 0.71–1.22 ) in men and 0.76 ( 95 % CI 0.56–1.03 ) in women . However , among participants with a higher vitamin D intake , calcium intake was inversely associated with diabetes risk ; the odds ratio for the highest vs lowest intake categories was 0.62 ( 95 % CI 0.41–0.94 ) in men and 0.59 ( 95 % CI 0.38–0.91 ) in women . Dairy food intake was significantly associated with a lower risk of type 2 diabetes in women only . Conclusions /interpretationCalcium and vitamin D may not be independently associated with type 2 diabetes risk . Our finding suggesting a joint action of these nutrients against type 2 diabetes warrants further investigation",
"OBJECTIVE : To investigate the effects of a yoghurt containing a novel fat emulsion on energy and macronutrient intakes up to 8 h post-consumption in non-overweight , overweight and obese subjects , and to assess energy compensation over the following 24 h. DESIGN : A double-blind , placebo-controlled , within-subject crossover design was used . Twenty ( 10 female , 10 male ) non-overweight ( body mass index ( BMI ) 20–24.9 kg/m2 ) , 20 ( 10 female , 10 male ) overweight ( BMI 25–29.9 kg/m2 ) and 20 ( 13 female , 7 male ) obese ( BMI > 30 kg/m2 ) subjects participated in the study . Subjects were given in r and om order , 7 days apart , either a 200 g portion of a test ( 5 g of a novel fat emulsion+1 g milk fat ) or control ( 6 g milk fat ) yoghurt at 09:00 h. At 4 and 8 h post-consumption subjects were given ad libitum access to a range of foods . Amounts of food consumed were determined by pre and post-covert weighing of individual serving dishes . Over the following 24 h subjects weighed and recorded all food intakes . RESULTS : Mean energy intakes were significantly lower after the test yoghurt compared with the control yoghurt in non-overweight ( 3.79 vs 5.43 MJ ; P . The corresponding macronutrient intakes were also significantly reduced in non-overweight and overweight subjects ( P , energy intakes over the following 24 h were also significantly reduced ( 6.35 vs 7.70 MJ ; P fat emulsion are maintained at least up to 8 h and are evident in non-overweight , overweight and obese subjects",
"Atopic dermatitis is a common inflammatory skin disease that especially affects children and adolescents . Many environmental factors have been recognized as relevant in aggravating skin lesions of the disease . However , it remains to be determined whether foods play a role in worsening of skin lesions in children with atopic dermatitis . In the present study , we investigated whether foods play a role in irregular aggravation of skin lesions in children with the disease . The study population consisted of 69 patients aged 3 - 15 years with atopic dermatitis . They were hospitalized and open challenge tests were performed with suspected foods . Photographs of representative skin lesion sites were taken at baseline and before and after the challenge . We determined challenge-positive foods by evaluating the comparable before/after challenge photographs . One to three ( average , 1.9 ) challenge-positive foods were confirmed in 52 ( 75 % ) of the 69 patients examined . Predominant offending foods were chocolate , cheese and yogurt . Specific immunoglobulin E values to offending foods were mostly negative . We asked patients to exclude challenge-positive foods from their diets . They were then discharged and followed up for 3 months at our outpatient clinic . Exclusion of the offending foods for 3 months brought about a remarkable improvement in the disease . These results suggest that foods play an important role in irregular aggravation of skin lesions in children with atopic dermatitis",
"Identification of dietary and lifestyle variables associated with the development of Parkinson ’s disease ( PD ) may offer pathogenetic clues and prevention opportunities . In a population -based prospect i ve cohort study , 26,173 participants in the EPIC – Greece cohort had sociodemographic , anthropometric , medical , dietary and lifestyle variables ascertained at enrolment and periodically reassessed with follow-up contacts . Based on these data , subjects were screened as possible PD cases if they ( 1 ) reported either a medical diagnosis of PD or use of anti-PD drugs and ( 2 ) did not report preceding causes of secondary parkinsonism . For diagnostic validation , possible incident PD cases were assessed by a focused 3-item telephone question naire . Cox proportional hazards regression was used to evaluate associations between potential predictors and incident PD . The main multivariate model included gender , age , marital status , schooling years , farming occupation , smoking status , caffeinated coffee , body mass index , physical activity and energy intake . Additional models included all above variables plus one dietary item at a time . Incidence rate adjusted to the European population was 16.9 per 100,000 person-years . In multivariate models , incident PD exhibited strong positive association with consumption of milk , but not cheese or yoghurt . This finding may help narrow down the search for potential dairy product components with a facilitatory role in PD . Concerning other dietary components , inverse association was found between polyunsaturated fat intake and incident PD . Also , inverse association was found with tobacco smoking , in line with previous studies , but not with caffeine",
"The authors prospect ively investigated the association between intake of dairy products and risk of Parkinson 's disease among 57,689 men and 73,175 women from the American Cancer Society 's Cancer Prevention Study II Nutrition Cohort . A total of 250 men and 138 women with Parkinson 's disease were identified during follow-up ( 1992 - 2001 ) . Dairy product consumption was positively associated with risk of Parkinson 's disease : Compared with the lowest intake quintile , the corresponding relative risks for quintiles 2 - 5 were 1.4 , 1.4 , 1.4 , and 1.6 ( 95 percent confidence interval ( CI ) : 1.1 , 2.2 ; p for trend = 0.05 ) . A higher risk among dairy product consumers was found in both men and women , although the association in women appeared nonlinear . Meta- analysis of all prospect i ve studies confirmed a moderately elevated risk of Parkinson 's disease among persons with high dairy product consumption : For extreme intake categories , relative risks were 1.6 ( 95 percent CI : 1.3 , 2.0 ) for both sexes , 1.8 for men ( 95 percent CI : 1.4 , 2.4 ) , and 1.3 for women ( 95 percent CI : 0.8 , 2.1 ) . These data suggest that dairy consumption may increase the risk of Parkinson 's disease , particularly in men . More studies are needed to further examine these findings and to explore underlying mechanisms",
"Few investigations reported the reductive effect of preload consuming on energy intake . The objective of the study was to compare the effects of consuming a mix of low glycaemic index foods such as vegetable salad , yogurt and water before or with meal on anthropometric measures and cardio vascular diseases ( CVD ) risks . In this r and omized controlled clinical trial , 25 men and 35 women were recruited to consume similar amounts of macronutrients within a hypocaloric diet for 3 months . Although subjects in the preload group consumed preload 15 min before the main meal , subjects in the control group consumed them with meal . The results showed that body weight , waist circumference , triglyceride , total cholesterol and systolic blood pressure decreased in more amount in the preload group ( − 7.8 ± 0.5 % , − 2.7 ± 0.2 % , − 5.7 ± 1.1 % , − 3.1 ± 0.53 % and − 4.4 ± 0.4 % , respectively ; p 0.05 for all ) . Fasting blood sugar and low density lipoprotein (LDL)-cholesterol decreased significantly only in the preload group . Consuming vegetable salad , yogurt and water as preload leads to greater changes in anthropometric measures and CVD risks",
"Fermented dairy products like yogurt have been suggested to protect against colorectal cancer ( CRC ) . We conducted a prospect i ve study on 45,241 ( 14,178 men ; 31,063 women ) volunteers of the EPIC‐Italy cohort who completed a dietary question naire including specific questions on yogurt intake . During 12 years of follow‐up , 289 volunteers were diagnosed with CRC . Hazard ratios ( HRs ) for the disease and 95 % confidence intervals ( CIs ) were estimated by Cox proportional hazard models , stratified by dietary question naire and adjusted for energy intake and other potential confounders . Yogurt intake was inversely associated with CRC risk . For the energy‐adjusted model , HR for CRC in the highest versus lowest tertile of yogurt intake was 0.62 ( 95 % CI , 0.46–0.83 ) . In the full model adjusted for energy , simple sugar , calcium , fiber , animal fat , alcohol and red meat intake , as well as body mass index , smoking , education and physical activity , HR was 0.65 ( 95 % CI , 0.48–0.89 ) in the highest versus lowest tertile . The protective effect of yogurt was evident in the entire cohort , but was stronger in men , although there was no interaction of sex with the yogurt – CRC association ( pinteraction 0.20 , fully adjusted model ) . In our prospect i ve study , high yogurt intake was significantly associated with decreased CRC risk , suggesting that yogurt should be part of a diet to prevent the disease . Investigation of larger cohorts is necessary to reveal any residual confounding of the association of yogurt intake with CRC risk",
"We compared the clinical outcome of acute diarrhea in 96 malnourished boys ( aged 4 to 47 months ) receiving full-strength milk compared with yogurt offered as part of a mixed diet . All had weight for height less than or equal to 80 % of the National Centre for Health Statistics median . They were r and omly assigned to receive milk formula ( MF ; 67 cal/100 ml ) or yogurt formula ( YF ; prepared from the same milk formula ) at the rate of 120 ml/kg body weight in seven divided feedings . Stool-reducing substances ( > 1 % ) were detected more frequently in the MF group , and the differences were significant for day 3 of the study ( p = 0.04 ) . However , the geometric mean ( 95 % confidence interval ) of the total stool weights ( gm/kg ) during 0 to 72 hours ( MF 128.8 [ 103 , 161.4 ] ; YF 110.9 [ 87 , 142.2 ] ) was comparable ( p = 0.37 ) as was the median ( range ) duration of diarrhea ( hours ) ( MF 45 [ 4 , 183 ] ; YF 52 [ 7 , 173 ] p = 0.94 ) . The treatment failure rates in the MF ( 8.2 % ) and YF ( 6.3 % ) groups were also similar ( p = 0.67 ) . The children consuming milk had higher median percent weight gain at the end of 72 hours of the study ( p = 0.04 ) and at recovery ( p = 0.02 ) . Routine substitution of yogurt as small frequent feedings as an addition for semisolid food to malnourished children with acute diarrhea does not achieve any significant clinical benefit versus milk",
"Previous studies have shown effects of high-protein diets , especially whey protein , on energy expenditure and satiety , yet a possible distinction between the effects of whey or alpha-lactalbumin has not been made . The present study assessed the effects of the addition of total whey protein ( whey ) or caseinomacropeptide-depleted alpha-lactalbumin-enriched whey protein ( alpha-lac ) to a breakfast yoghurt drink on energy expenditure and appetite suppression in human subjects . A total of eighteen females and seventeen males ( aged 20.9 ( sd 1.9 ) years ; BMI 23.0 ( sd 2.1 ) kg/m2 ) participated in an experiment with a r and omised , three-arm , cross-over design where diet-induced energy expenditure , respiratory quotient and satiety were measured . Breakfasts were isoenergetic and subject-specific : a normal-protein ( NP ) breakfast consisting of whole milk ( 15 , 47 and 38 % energy from protein , carbohydrate and fat , respectively ) , a high-protein ( HP ) breakfast with additional whey or a HP breakfast containing alpha-lac ( 41 , 47 and 12 % energy from protein , carbohydrate and fat , respectively ) . Resting energy expenditure did not differ between the three conditions . HP breakfasts ( area under the curve : whey , 217.1 ( se 10.0 ) kJ x 4 h ; alpha-lac , 234.3 ( se 11.6 ) kJ x 4 h ; P diet-induced thermogenesis more compared with a NP yoghurt at breakfast ( 179.7 ( se 10.9 ) kJ x 4 h ; P Hunger and desire to eat were significantly more suppressed after alpha-lac ( hunger , - 6627 ( se 823 ) ; desire to eat , - 6750 ( se 805 ) mm visual analogue scale ( VAS ) x 4 h ; P positive protein balance occurred ( alpha-lac , 0.35 ( sd 0.18 ) MJ/4 h ; whey , 0.37 ( sd 0.20 ) MJ/4 h ; P positive fat balance occurred ( 1.03 ( sd 0.29 ) MJ/4 h ; P breakfast yoghurt drink with added whey or alpha-lac increased energy expenditure , protein balance and decreased fat balance compared with a NP breakfast . The alpha-lac-enriched yoghurt drink suppressed hunger and the desire to eat more than the whey-enriched yoghurt drink",
"Although the pathophysiology of persistent diarrhea in children remains unclear , it has been suggested that it may be related to the composition of the food ingested . Since lactase deficiency and cow 's milk protein intolerance are often identified in children with persistent diarrhea , replacement of milk with yogurt should be beneficial . We , therefore , compared the clinical outcome of children ( aged 3–36 months ) with persistent diarrhea r and omly assigned to receive either milk or yogurt for 5 days . Preliminary results on 45 of the 100 children indicated clinical failure , which was determined after a 5 % loss of body weight per day or the persistence of diarrhea after 5 days , in only 14 % of the children fed yogurt compared to 42 % of those fed milk ( p < 0.05 ) . These preliminary results strongly suggest a clinical advantage of feeding yogurt rather than milk in children with persistent diarrhea",
"Objective : Plant sterols ( PS ) consumed as a snack may not have the same cholesterol-lowering potential as when consumed with a meal due to poor solubilization . It was hypothesized that the consumption of a single dose , low-fat yogurt rich in PS ( 1.6 g/d ) with a meal over an afternoon snack will lead to favourable changes in plasma lipids , plasma PS concentrations , and cholesterol synthesis without negatively affecting α-tocopherol or carotenoids levels . Methods : Twenty-six hyperlipidemic males and females completed the r and omized trial of three phases ( control , single PS dose consumed with a meal , or single PS dose as an afternoon snack ) while consuming controlled , low-fat diets . Plasma lipids , cholesterol synthesis rates , plasma PS and serum fat-soluble antioxidants were measured at baseline and after 4 weeks . Results : Endpoint total cholesterol ( TC ) levels after the PS snack phase were decreased ( p = 0.04 ) ( 5.30 ± 0.2 mmol/L ) compared to the control phase ( 5.53 ± 0.2 mmol/L ) . However , endpoints for TC ( 5.37 ± 0.2 mmol/L ) for PS dose with a meal were comparable to control phase . Low-density lipoprotein-cholesterol tended to be different ( p = 0.06 ) at the end of the intervention phases ( 3.51 ± 0.1 , 3.43 ± 0.1 , and 3.33 ± 0.1 mmol/L ; control , meal and snack , respectively ) . Cholesterol fractional synthesis rates were higher ( p = 0.007 ) by 25.8 % and 19.5 % at the end of the snack and meal phases , respectively , compared with the control phase . Plasma campesterol and β-sitosterol concentrations , adjusted for TC , were higher ( p respectively ) . No changes in α-tocopherol or carotenoids levels were detected after adjusting for TC , for all phases . Conclusion : These results indicate that a single dose of PS in low-fat yogurt , provided as a snack , lowers cholesterol levels but does not alter fat-soluble vitamin or carotenoid concentrations in hyperlipidemic participants",
"The present study was design ed to evaluate the independent and interactive effects of a once-a-day yoghurt drink providing 2 g plant sterols/d and capsules providing 2 g fish oil n-3 long-chain ( LC ) PUFA/d on plasma lipids , apolipoproteins and LDL particle size . Following a 2-week run-in period , 200 mildly hypercholesterolaemic Indian adults aged 35 - 55 years were r and omised into one of four groups of a 2 x 2 factorial , double-blind controlled trial . The 4-week treatments consisted of ( 1 ) control yoghurt drink and control capsules , ( 2 ) control yoghurt drink and fish oil capsules , ( 3 ) plant sterol-enriched yoghurt drink and control capsules , or ( 4 ) plant sterol-enriched yoghurt drink and fish oil capsules . Blood was drawn before and after the 4-week intervention . Changes in health status , lifestyle and dietary habits , and daily compliance were recorded . The main effects of plant sterols were a 4.5 % reduction in LDL-cholesterol and a 15 % reduction in TAG without a significant change in HDL-cholesterol . Overall , fish oil n-3 LC-PUFA did not significantly affect cholesterol concentrations but reduced TAG by 15 % and increased HDL-cholesterol by 5.4 % . The combination significantly lowered TAG by 15 % v. control . No significant interaction between plant sterols and n-3 LC-PUFA was observed on plasma cholesterol concentrations . In conclusion , once-a-day intake of 2 g plant sterols/d in a yoghurt drink , 2 g fish oil n-3 LC-PUFA/d in capsules , and their combination had beneficial effects on the lipid profile of mildly hypercholesterolaemic Indian adults . The potent hypotriacylglycerolaemic effect of plant sterols observed in the present study and this population warrants additional investigation",
"Some previous studies have suggested that consuming dairy products , particularly the low-fat variety , lowers the incidence of type 2 diabetes . However , no study to our knowledge has focused on an ethnically diverse group of postmenopausal women , a population with a high risk of this disease . We conducted a prospect i ve cohort study of 82,076 postmenopausal women enrolled in the Women 's Health Initiative Observational Study who did not report diabetes at enrollment . Total , low-fat , and high-fat dairy product and yogurt intakes were estimated from FFQ at baseline and 3 y of follow-up . Treated diabetes incidence was ascertained from annual follow-up question naires . During 8 y of follow-up , 3946 cases of incident treated diabetes were reported ( annual incidence , 0.73 % ; cumulative incidence , 4.8 % ) . After multivariable adjustment , low-fat dairy product consumption was inversely associated with the risk of type 2 diabetes . RR was roughly 0.5 - 0.6 in the upper quintiles compared with the lowest quintile ( median servings/d , 2.8 in the 5th quintile and 1.5 in the 4th quintile vs. 0.05 in the first quintile ; P-trend women with a higher BMI . High yogurt consumption was associated with a significant decrease in diabetes risk , whereas there was no relationship between high-fat dairy product consumption and diabetes risk . A diet high in low-fat dairy products is associated with lower diabetes risk in postmenopausal women , particularly those who are obese",
"OBJECTIVE Lactoferrin , a whey milk protein after removing precipitated casein , has a prominent activity against inflammation in vitro and systemic effects on various inflammatory diseases have been suggested . The objective was to determine dietary effects of lactoferrin-enriched fermented milk on patients with acne vulgaris , an inflammatory skin condition . METHODS Patients 18 to 30 y of age were r and omly assigned to ingest fermented milk with 200 mg of lactoferrin daily ( n = 18 , lactoferrin group ) or fermented milk only ( n = 18 , placebo group ) in a 12-wk , double-blind , placebo-controlled study . Acne lesion counts and grade were assessed at monthly visits . The condition of the skin by hydration , sebum and pH , and skin surface lipids was assessed at baseline and 12 wk . RESULTS Acne showed improvement in the lactoferrin group by significant decreases in inflammatory lesion count by 38.6 % , total lesion count by 23.1 % , and acne grade by 20.3 % compared with the placebo group at 12 wk . Furthermore , sebum content in the lactoferrin group was decreased by 31.1 % compared with the placebo group . The amount of total skin surface lipids decreased in both groups . However , of the major lipids , amounts of triacylglycerols and free fatty acids decreased in the lactoferrin group , whereas the amount of free fatty acids decreased only in the placebo group . The decreased amount of triacylglycerols in the lactoferrin group was significantly correlated with decreases in serum content , acne lesion counts , and acne grade . No alterations in skin hydration or pH were noted in either group . CONCLUSION Lactoferrin-enriched fermented milk ameliorates acne vulgaris with a selective decrease of triacylglycerols in skin surface lipids",
"In vivo and in vitro studies have suggested a protective role of calcium and vitamin D in the development of colorectal cancer . However , epidemiologic data have been inconclusive . The authors prospect ively assessed intakes of calcium and vitamin D in relation to risk of colorectal cancer in a large , prospect i ve , female cohort from the US Women 's Health Study . In 1993 , 39,876 women aged > or = 45 years and free of cardiovascular disease and cancer were enrolled in the study . During an average follow-up of 10 years , 223 of 36,976 women eligible for the present study developed colorectal cancer . Intakes of calcium and vitamin D from dietary sources and supplements were assessed with a baseline food frequency question naire . Cox proportional hazards regression was used to estimate relative risks and 95 % confidence intervals . Intakes of total calcium and vitamin D were not associated with risk of colorectal cancer ; multivariate relative risks comparing the highest with the lowest quintile were 1.20 ( 95 % confidence interval : 0.79 , 1.85 ; p for trend = 0.21 ) for total calcium and 1.34 ( 95 % confidence interval : 0.84 , 2.13 ; p for trend = 0.08 ) for total vitamin D. Intakes of both nutrients from specific types of sources , including diet and supplements , were also not significantly associated with colorectal cancer risk . Data provide little support for an association of calcium and vitamin D intake with colorectal cancer risk",
"Milk has been considered a risk factor for atherosclerosis and coronary heart disease ( CHD ) because of its content in cholesterol , saturated fatty acids , and possibly lactose . However , epidemiological data are scanty and inconclusive . A Scottish prospect i ve study found a relative risk of 0.92 for CHD in men with higher milk intake , and the preliminary analyses of the Caerphilly study found a protective association.1 No significant relation with CHD was found in other prospect i ve studies , including the British Regional Heart study conducted in men ( relative risk , RR , 0.88 for drinkers compared with non-drinkers),2 a British study on vegetarians ( increased risk in high milk consumers and reduced in moderate consumers),3 and the Iowa study in postmenopausal women ( RR 0.94 for the highest tertile of intake compared with the lowest),4 although absolute numbers of events were limited . An Italian case-control study of acute myocardial infa rct ion ( AMI ) in women found",
"Abstract Background . A number of epidemiological studies have examined the association between use of dairy products and risk of ovarian cancer , but results are conflicting . Using data from a large Danish population -based case-control study we here further examined the association between dairy consumption , lactose , and calcium and risk of overall ovarian cancer and histological types of ovarian cancer . Material and methods . In the period 1995–1999 we included 554 women with epithelial ovarian cancer and 1554 r and omly selected age-matched controls ( 35–79 years ) . All women participated in a detailed personal interview that included questions about dairy consumption . Data were analysed using multiple logistic regression models . Results . Total dairy intake was associated with ovarian cancer risk ( OR = 1.11 ; 95 % CI : 1.07–1.15 per 100 ml/day ) . The association was strongest for milk [ OR = 1.14 ; 95 % CI : 1.03–1.27 per glass ( 200 ml)/day ] , soured milk products [ OR = 1.49 ; 95 % CI : 1.22–1.81 per portion ( 250 ml)/day ] and yoghurt [ OR = 1.65 ; 95 % CI : 1.22–2.23 per portion ( 250 ml)/day ] . In contrast , intake of cheese was associated with a decreased risk [ OR = 0.70 ; 95 % CI : 0.55–0.89 for > 1 portion ( 100 ml)/day compared with no intake ] . Intake of lactose , but not calcium , was also associated with an increased ovarian cancer risk ( OR = 1.24 ; 95 % CI : 1.10–1.40 per 10 g of lactose/day ) . Similar risk patterns were observed for the different histological types of ovarian cancer , indicating virtually identical aetiologies with regard to dairy intake , lactose , and calcium . Conclusions . Our results indicate that intake of dairy products is associated with a modest increased risk of ovarian cancer . In addition , ovarian cancer development was associated with lactose",
"This in vivo study assessed plaque pH in subjects following the consumption of different dairy products . After receiving parental consent to participate , subjects ( 12 - 15 years old ) were asked to refrain from brushing their teeth for 48 hours prior to the study . At baseline , plaque pH was determined at 4 different sites . Each of the subjects was then assigned r and omly to 1 of 4 subgroups and each subgroup was given either cheese , milk , yogurt , or paraffin ( control ) . After baseline , all subjects were allowed to chew and /or swish their respective product for 3 minutes and pH was assessed subsequently at different time intervals . Statistical analysis was performed using unpaired t-test and 1-way ANOVA . The results showed a statistically significant change in mean plaque pH after consuming different dairy products , as the plaque pH after 30 minutes was higher in the cheese group than that of the milk and yogurt groups , both of which showed a pH toward baseline after 30 minutes . These results suggest that cheese has the highest anticariogenic property among the dairy products studied , and that milk and yogurt can be considered as noncariogenic",
"OBJECTIVE Although the genetic component in colorectal carcinoma ( CRC ) is well established , some environmental factors , mainly dietary , can favor its development . The objective of this study is to evaluate the relationship between daily consumption of specific food groups and development of CRC . METHODS We carried out a case-control study in an area of Madrid ; 196 patients with diagnosis of CRC with confirmed histology and registered to May 1998 in the Community of Madrid tumor register were included , and they were compared with 196 controls matched by age , sex , and geographical area . All of them filled out a question naire with information on diet , substance abuse , physical activity , drugs , and family history of CRC . RESULTS The logistic regression analysis showed a weakly positive association with meat ( OR : 1.02 ; CI : 1.01 - 1.04 ) , viscera ( OR : 1.12 ; CI : 1.02 - 1.23 ) , and sausage ( OR : 1.07 ; CI : 1.03 - 1.1 ) consumption , and a modest inverse association with consumption of yogurt ( OR : 0.97 ; CI : 0.95 - 0.98 ) , tomato ( OR : 0.99 ; CI : 0.98 - 0.99 ) , strawberries and cherries ( OR : 0.97 ; CI : 0.95 - 0.99 ) , oranges , grapefruits , and natural fruit juices ( OR : 0.99 ; CI : 0.98 - 1 ) . CONCLUSIONS These results are an additional empirical evidence that must be confirmed through prospect i ve studies",
"The purpose of this trial is to evaluate the clinical efficacy and cost/effectiveness of Saccharomyces boulardii compared with yogurt fluid ( YF ) in acute non-bloody diarrhea in children . This r and omized , prospect i ve open-label clinical trial includes 55 children ( 36 boys , 19 girls ; mean age 21.2 + /- 28.2 months ) . Group A ( N = 28 ) received lyophilized S. boulardii and group B ( N = 27 ) received YF . The duration of diarrhea was shorter with S. boulardii but the hospital stay was reduced with YF , although these differences were not significant . However , diarrhea had resolved in significantly more children on day 3 in the S. boulardii group ( 48.5 % versus 25.5 % ; P yogurt treatment was cheaper than S. boulardii whereas in hospitalized patients , treatment cost was similar . In conclusion , the effect of daily freshly prepared YF was comparable to S. boulardii in the treatment of acute non-bloody diarrhea in children . The duration of diarrhea was shorter in the S. boulardii group , expressed as a significantly higher number of patients with normal stools on day 3",
"CONTEXT Nutritional prevention of bone deterioration with fortified foods seems particularly suitable in institutionalized elderly women at risk of vitamin D deficiency , secondary hyperparathyroidism , increased bone resorption , and osteoporotic fracture . OBJECTIVE The objective was to evaluate whether fortification of yogurts with vitamin D and calcium exerts an additional lowering effect on serum PTH and bone resorption markers as compared with isocaloric and isoprotein dairy products in elderly women . DESIGN A r and omized double-blind controlled-trial , 56-day intervention was conducted in institutionalized women ( mean age 85.5 years ) consuming 2 125-g servings of either vitamin D- and calcium-fortified yogurt ( FY ) at supplemental levels of 10 μg/d vitamin D₃ and 800 mg/d calcium or nonfortified control yogurt ( CY ) providing 280 mg/d calcium . MAIN OUTCOMES The endpoints were serum changes from baseline ( day 0 ) to day 28 and day 56 in 25-hydroxyvitamin-D ( 25OHD ) , PTH , and bone resorption markers tartrate-resistant acid phosphatase isoform-5b ( TRAP5b ) , the primary outcome , and carboxyl-terminal cross-linked telopeptide of type I collagen ( CTX ) . RESULTS At day 56 , serum 25OHD increased ( mean ± SEM ) by 25.3 ± 1.8 vs 5.2 ± 2.5 nmol/L in FY ( n = 29 ) and CY ( n = 27 ) , respectively ( P corresponding changes in PTH were -28.6 % ± 7.2 % vs -8.0 % ± 4.3 % ( P = .0003 ) ; in TRAP5b , -21.9 % ± 4.3 % vs 3.0 % ± 3.2 % ( P for 25OHD , PTH , and TRAP5b . CONCLUSIONS This study in institutionalized elderly at high risk for osteoporotic fracture suggests that fortification of dairy products with vitamin D₃ and calcium provides a greater prevention of accelerated bone resorption as compared with nonfortified equivalent foods"
] | 41163940-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE To conduct a systematic review and meta- analysis of r and omized trials that assessed the effect of testosterone use on cardiovascular events and risk factors in men with different degrees of and rogen deficiency . METHODS Librarian- design ed search strategies were used to search the MEDLINE ( 1966 to October 2004 ) , EMBASE ( 1988 to October 2004 ) , and Cochrane CENTRAL ( inception to October 2004 ) data bases . The data base search was performed again in March 2005 . We also review ed reference lists from included studies and content expert files . Eligible studies were r and omized trials that compared any formulation of commercially available testosterone with placebo and that assessed cardiovascular risk factors ( lipid fractions , blood pressure , blood glucose ) , cardiovascular events ( cardiovascular death , nonfatal myocardial infa rct ion , angina or claudication , revascularization , stroke ) , and cardiovascular surrogate end points ( ie , laboratory tests indicative of cardiac or vascular disease ) . Using a st and ardized data extraction form , we collected data on participants , testosterone administration , and outcome measures . We assessed study quality with attention to allocation concealment , blinding , and loss to follow-up . RESULTS The 30 trials included 1642 men , 808 of whom were treated with testosterone . Overall , the trials had limited reporting of method ological features that prevent biased results ( only 6 trials reported allocation concealment ) , enrolled few patients , and were of brief duration ( only 4 trials followed up patients for > 1 year ) . The median loss to follow-up across all 30 trials was 9 % . Testosterone use in men with low testosterone levels led to inconsequential changes in blood pressure and glycemia and in all lipid fractions ( total cholesterol : odds ratio [ OR ] , -0.22 ; 95 % confidence interval [ CI ] , -0.71 to 0.27 ; high-density lipoprotein cholesterol : OR , -0.04 ; 95 % CI , -0.39 to 0.30 ; low-density lipoprotein cholesterol : OR , 0.06 ; 95 % CI , -0.30 to 0.42 ; and triglycerides : OR , -0.27 ; 95 % CI , -0.61 to 0.08 ) ; results were similar in patients with low-normal to normal testosterone levels . The OR between testosterone use and any cardiovascular event pooled across trials that reported these events ( n = 6 ) was 1.82 ( 95 % CI , 0.78 to 4.23 ) . Several trials failed to report data on measured outcomes . For reasons we could not explain statistically , the results were inconsistent across trials . CONCLUSION Currently available evidence weakly supports the inference that testosterone use in men is not associated with important cardiovascular effects . Patients and clinicians need large r and omized trials of men at risk for cardiovascular disease to better inform the safety of long-term testosterone use | [
"Testosterone has immune-modulating properties , and current in vitro evidence suggests that testosterone may suppress the expression of the proinflammatory cytokines TNFalpha , IL-1beta , and IL-6 and potentiate the expression of the antiinflammatory cytokine IL-10 . We report a r and omized , single-blind , placebo-controlled , crossover study of testosterone replacement ( Sustanon 100 ) vs. placebo in 27 men ( age , 62 + /- 9 yr ) with symptomatic and rogen deficiency ( total testosterone , 4.4 + /- 1.2 nmol/liter ; bioavailable testosterone , 2.4 + /- 1.1 nmol/liter ) . Compared with placebo , testosterone induced reductions in TNFalpha ( -3.1 + /- 8.3 vs. 1.3 + /- 5.2 pg/ml ; P = 0.01 ) and IL-1beta ( -0.14 + /- 0.32 vs. 0.18 + /- 0.55 pg/ml ; P = 0.08 ) and an increase in IL-10 ( 0.33 + /- 1.8 vs. -1.1 + /- 3.0 pg/ml ; P = 0.01 ) ; the reductions of TNFalpha and IL-1beta were positively correlated ( r(S ) = 0.588 ; P = 0.003 ) . In addition , a significant reduction in total cholesterol was recorded with testosterone therapy ( -0.25 + /- 0.4 vs. -0.004 + /- 0.4 mmol/liter ; P = 0.04 ) . In conclusion , testosterone replacement shifts the cytokine balance to a state of reduced inflammation and lowers total cholesterol . Twenty of these men had established coronary disease , and because total cholesterol is a cardiovascular risk factor , and proinflammatory cytokines mediate the development and complications associated with atheromatous plaque , these properties may have particular relevance in men with overt vascular disease",
"Serum and rogen levels decline with aging in normal males , such that a significant number of men over 60 yr of age will have a mean serum total testosterone ( T ) level near the low end of the normal adult range . It is not known whether lower T levels in older men have an effect on and rogen-responsive organ systems , such as muscle , bone , bone marrow , and prostate , nor are there data to evaluate the relative benefits and risks of T supplementation in older men . We assessed the physiological and biochemical effects of T therapy in 13 healthy men , 57 - 76 yr old , who had low or borderline low serum T levels ( Intramuscular testosterone enanthate ( TE ; 100 mg weekly ) and placebo injections were given for 3 months each . Before treatment and at the end of both 3-month treatment regimens , lean body mass , body fat , biochemical parameters of bone turnover , hematological parameters , lipoprotein profiles , and prostate parameters [ such as prostate-specific antigen ( PSA ) ] were evaluated . Serum T levels rose in all subjects with TE treatment , such that the lowest level of T during a week 's period was 19.7 + /- 0.7 nmol/L ( mean + /- SE ) . After 3 months of TE treatment , lean body mass was significantly increased , and urinary hydroxyproline excretion was significantly depressed . With TE treatment , there was a significant increase in hematocrit , a decline in total cholesterol and low density lipoprotein cholesterol , and a sustained increase in serum PSA levels . Placebo treatment led to no significant changes in any of these parameters . We conclude that short term ( 3 months ) TE supplementation to healthy older men who have serum T levels near or below the lower limit of normal for young adult men results in an increase in lean body mass and possibly a decline in bone resorption , as assessed by urinary hydroxyproline excretion , with some effect on serum lipoproteins , hematological parameters , and PSA . The sustained stimulation of PSA and the increase in hematocrit that occur with physiological TE supplementation suggest that older men should be screened carefully and followed periodically throughout T therapy",
"Decreases in growth hormone ( GH ) and insulin-like growth factor I occur with age , in addition to oestrogen deficiency in women and a reduction in the levels of testosterone in men . These age-related hormonal changes may contribute to reductions in lean body mass , muscle strength and cardiac endurance , which can be partially reversed in elderly people with GH treatment , and testosterone supplements and oestrogen/progestin hormone replacement therapy in men and women , respectively . These treatments are , however , thought to have potentially serious adverse effects . We conducted a study to evaluate the separate and interactive effects of GH and sex steroids on body composition , muscle strength and cardiac endurance as well as the rate of adverse events in healthy elderly people . The results of the study showed that although there were beneficial effects with GH and sex steroid treatment , a high percentage of adverse effects occurred after 26 weeks of treatment , demonstrating a need for more research on the safety of hormonal therapy in the elderly population",
"Older men , particularly those with low serum testosterone ( T ) levels , might benefit from T therapy to improve bone mineral density ( BMD ) and reduce fracture risk . Concerns exist , however , about the impact of T therapy on the prostate in older men . We hypothesized that the combination of T and finasteride ( F ) , a 5 alpha-reductase inhibitor , might increase BMD in older men without adverse effects on the prostate . Seventy men aged 65 yr or older , with a serum T less than 12.1 nmol/liter on two occasions , were r and omly assigned to receive one of three regimens for 36 months : T enanthate , 200 mg i m every 2 wk with placebo pills daily ( T-only ) ; T enanthate , 200 mg every 2 wk with 5 mg F daily ( T+F ) ; or placebo injections and pills ( placebo ) . Low BMD was not an inclusion criterion . We obtained serial measurements of BMD of the lumbar spine and hip by dual x-ray absorptiometry . Prostate-specific antigen ( PSA ) and prostate size were measured at baseline and during treatment to assess the impact of therapy on the prostate . Fifty men completed the 36-month protocol . By an intent-to-treat analysis including all men for as long as they contributed data , T therapy for 36 months increased BMD in these men at the lumbar spine [ 10.2 + /- 1.4 % ( mean percentage increase from baseline + /- SEM ; T-only ) and 9.3 + /- 1.4 % ( T+F ) vs. 1.3 + /- 1.4 % for placebo ( P hip [ 2.7 + /- 0.7 % ( T-only ) and 2.2 + /- 0.7 % ( T+F ) vs. -0.2 + /- 0.7 % for placebo , ( P increases in BMD were seen also in the intertrochanteric and trochanteric regions of the hip . After 6 months of therapy , urinary deoxypyridinoline ( a bone-resorption marker ) decreased significantly compared with baseline in both the T-only and T+F groups ( P PSA increased significantly from baseline in the T-only group ( P Prostate volume increased in all groups during the 36-month treatment period , but this increase was significantly less in the T+F group compared with both the T-only and placebo groups ( P = 0.02 ) . These results demonstrate that T therapy in older men with low serum T increases vertebral and hip BMD over 36 months , both when administered alone and when combined with F. This finding suggests that dihydrotestosterone is not essential for the beneficial effects of T on BMD in men . In addition , the concomitant administration of F with T appears to attenuate the impact of T therapy on prostate size and PSA and might reduce the chance of benign prostatic hypertrophy or other prostate-related complications in older men on T therapy . These findings have important implication s for the prevention and treatment of osteoporosis in older men with low T levels",
"Transbuccal administration of drugs provides an easy route of administration . To test the safety and efficacy of a novel testosterone ( T ) product , we performed a r and omized , double blind , placebo-controlled study in a parallel design . Men with serum T levels below 250 ng/dL were administered either an active buccal tablet containing 10 mg T ( n = 7 ) or a buccal placebo tablet ( n = 6 ) containing 3 mg pseudoephedrine HCl for taste matching . Men were studied while taking a st and ard T enanthate dose , after 6 weeks of a wash-out period , and after 8 weeks of therapy . The men were matched for age ( mean + /- SD , 41 + /- 16 vs. 47 + /- 16 ) and type of hypogonadism ( three primary testicular failures in each group , with the remainder having a central etiology ) . Acute pharmacokinetic testing showed peak serum hormone levels at 30 min , with a mean serum T concentration of 2688 + /- 147 ng/dL ( range , 1820 - 3770 ng/dL ) . Levels returned to baseline in 4 - 6 h , result ing in a total T area under the curve level of 3865 ng/hn.dL , less than that using other available forms of T administration . Similar pharmacokinetics were observed for the hormone 's metabolites , bioavailable T , free T , and estradiol . After 8 weeks of treatment , the results of nocturnal penile tumescence studies evaluating rigidity and circumference were significantly different from those in the placebo group ( P therapy . In conclusion , transbuccal T therapy was sufficient to maintain normal sexual function while minimizing the total time of exposure to elevated circulating serum T levels",
"Long-term glucocorticoid therapy in men is associated with loss of bone and muscle mass as well as a decrease in serum testosterone . We tested the effect of two and rogens , testosterone and its minimally aromatizable analog n and rolone , on muscle mass ( dual x-ray absorptiometry ) , muscle strength ( knee flexion and extension by isokinetic dynamometry ) , bone mineral density ( BMD ) , and quality of life ( Qualeffo-41 question naire ) in 51 men on a mean daily prednisone dose of 12.6 + /- 2.2 mg . Men were r and omized , double blind , to testosterone ( 200 mg mixed esters ) , n and rolone decanoate ( 200 mg ) , or placebo given every fortnight by i m injection for 12 months . At 12 months , both and rogens increased muscle mass ( mean change from baseline + 3.5 % , + 5.8 % , and -0.9 % in testosterone , n and rolone , and placebo groups , respectively , P muscle strength ( P Lumbar spine BMD increased significantly only in men treated with testosterone ( 4.7 + /- 1.1 % , P hip or total body BMD . Testosterone , but not n and rolone or placebo , improved overall quality of life ( P and rogen therapy may have a role in ameliorating adverse effects of glucocorticoid therapy such as muscle and bone loss and aromatization is necessary for and rogen action on bone but not on muscle",
"The male aging process brings about declines in hormonal function including a gradual decline in bioavailable testosterone levels . Animal studies suggest that testosterone modulates cognitive function through enhancing acetylcholine release and up-modulation of nicotinic receptors . Tau protein deposition is also affected by and rogen supplementation in animals . We hypothesize that testosterone replacement in elderly hypogonadal males may improve cognition , in particular the visual-spatial domain . Thirty-six male patients with a new diagnosis of Alzheimer 's disease had their total and bioavailable testosterone levels measured . None of the patients had been on acetylcholinesterase inhibitors . Ten of the 36 patients ( 28 % ) were deemed biochemically hypogonadal ( total testosterone testosterone and five to placebo . Initial Alzheimer 's Disease Assessment Scale cognitive subscale ( ADAScog ) and Mini Mental Status Examination ( MMSE ) ranged from 31 to 19 and from 17 to 22 , respectively . The clock drawing test ( CDT ) and the pentagon-tracing portion of the MMSE were used as measures of visual-spatial abilities . Normal prostate-specific antigen ( PSA ) levels were essential before treatment with intramuscular testosterone , 200 mg every 2 weeks . Measurement of testosterone , complete blood count , lipids , PSA and neuropsychological cognitive tests were repeated at 3 , 6 , 9 and 12 months of treatment . In the testosterone-treated group , levels of total testosterone increased from a mean of 126.4 ng/dl to 341 ng/dl or 3.6 nmol/l to 9.7 nmol/l ( p = 0.11 ) . Bioavailable testosterone also increased from a mean of 48.7 ng/dl to 142 ng/dl or 1.39 nmol/l to 4.05 nmol/l ( p = 0.10 ) . PSA levels were also elevated from a mean of 0.98 to 1.37 ng/ml ( p = 0.07 ) . ADAScog improved from a mean of 25 to 16.3 ( p = 0.02 ) ; MMSE improved from a mean of 19.4 to 23.2 ( p = 0.02 ) , CDT also improved from 2.2 to 3.2 ( p = 0.07 ) . One patient stopped treatment because of hypersexual behavior . The placebo-treated group deteriorated gradually . This small pilot study performed in aging male patients suggests that testosterone could indeed improve cognition , including visual-spatial skills in mild to moderate Alzheimer 's disease",
"A r and omised double blind study was carried out with 50 men who had ST segment depression of 0.1 mV or more after a modified two-step exercise test . Rate and duration of exercise were the same for the last of each subject 's several pretreatment tests as for his tests after 4 and 8 weeks of treatment with placebo or testosterone cypionate , 200 mg , intramuscularly weekly . The sum of ST segment depression in leads II , V4 , V5 , and V6 taken immediately , and 2 , 4 , and 6 minutes after exercise did not change significantly after 4 or 8 weeks of placebo treatment , but did decrease by 32 per cent ( P less than 0.0001 ) and 51 per cent ( P less than 0.0001 ) after 4 and 8 weeks , respectively , of testosterone cypionate treatment . The mechanism by which testosterone cypionate treatment results in lessened postexercise ST segment depression is not established",
"Dysfunction of the muscles of ambulation contributes to exercise intolerance in chronic obstructive pulmonary disease ( COPD ) . Men with COPD have high prevalence of low testosterone levels , which may contribute to muscle weakness . We determined effects of testosterone supplementation ( 100 mg of testosterone enanthate injected weekly ) with or without resistance training ( 45 minutes three times weekly ) on body composition and muscle function in 47 men with COPD ( mean FEV(1 ) = 40 % predicted ) and low testosterone levels ( mean = 320 ng/dl ) . Subjects were r and omized to 10 weeks of placebo injections + no training , testosterone injections + no training , placebo injections + resistance training , or testosterone injections + resistance training . Testosterone injections yielded a mean increase of 271 ng/dl in the nadir serum testosterone concentration ( to the middle of the normal range for young men ) . The lean body mass ( by dual-energy X-ray absorptiometry ) increase averaged 2.3 kg with testosterone alone and 3.3 kg with combined testosterone and resistance training ( p Increase in one-repetition maximum leg press strength averaged 17.2 % with testosterone alone , 17.4 % with resistance training alone , and 26.8 % with testosterone + resistance training ( p tolerated with no abnormalities in safety measures . Further studies are required to determine long-term benefits of adding testosterone supplementation and resistance training to rehabilitative programs for carefully screened men with COPD and low testosterone levels",
"BACKGROUND Sex hormones are known to affect cholesterol levels and vascular tone in women . The effects of testosterone on cholesterol and vascular tone in men are less well understood . Low testosterone levels have been associated with higher cholesterol levels in epidemiologic studies , but testosterone replacement has result ed in variable changes in cholesterol levels . Similarly , clinical studies suggest that testosterone may be vasodilatory , but few studies have directly evaluated the effects of testosterone on vascular tone . METHODS Sixty-seven men ( mean age 76 + /- 4 years , range 65 - 87 ) with bioavailable testosterone levels below 4.44 nmol/l ( lower limit for adult normal range ) were r and omized to receive transdermal testosterone ( 2 - 2.5 mg patches/d ) or placebo patches for 1 year . Twenty-three men ( 34 % ) withdrew from the study ; 44 men completed the trial . RESULTS While total cholesterol , triglyceride , and low-density lipoprotein cholesterol levels did not significantly change during the year of therapy , high-density lipoprotein ( HDL ) levels ( p = .004 ) and , specifically , HDL(2 ) subfraction ( p = .02 ) decreased in men receiving testosterone supplementation . Vascular tone was measured by brachial artery reactivity in 36 men . Endothelium-dependent brachial artery reactivity did not change from baseline measurements in men receiving transdermal testosterone ( 0.3 + /- 6.7 % to 1.6 + /- 4.6 % ; p = .58 ) or in the placebo group ( 3.2 + /- 5.5 % to 0.7 + /- 5.5 % ; p = .23 ) . CONCLUSIONS Transdermal testosterone decreased HDL(2 ) cholesterol but did not affect vascular reactivity in men older than 65 years selected for low testosterone levels . No study to date has addressed the direct relationship between testosterone replacement and cardiovascular events",
"Testosterone ( T ) therapy in older men with low serum T levels increases lean body mass and decreases fat mass . These changes might improve physical performance and strength ; however , it has not been established whether T therapy improves functional outcome in older men . Moreover , concerns exist about the impact of T therapy on the prostate in older men . The administration of finasteride ( F ) , which partially blocks the conversion of T to the more potent and rogen , dihydrotestosterone , attenuates the impact of T replacement on prostate size and prostate-specific antigen . We hypothesized that T replacement in older , hypogonadal men would improve physical function and that the addition of F to this regimen would continue to provide the T-induced improvements in physical performance , strength , and body composition . Seventy men with low serum T ( , were r and omly assigned to receive one of three regimens for 36 months : 1 ) T enanthate , 200 mg i m every 2 wk , with placebo pills daily ( T-only ) ; 2 ) T enanthate , 200 mg every 2 wk , with 5 mg F daily ( T + F ) ; or 3 ) placebo injections and pills ( placebo ) . We obtained serial measurements of timed physical performance , grip strength , lower extremity strength , body composition ( by dual-energy x-ray absorptiometry ) , fasting cholesterol profiles , and hormones . Fifty men completed the 36-month protocol . After 36 months , T therapy significantly improved performance in a timed functional test when compared with baseline and placebo [ 4.3 + /- 1.6 % ( mean + /- sem , T-only ) and 3.8 + /- 1.0 % ( T + F ) vs. -5.6 + /- 1.9 % for placebo ( P h and grip strength compared with baseline and placebo ( P lean body mass [ 3.77 + /- 0.55 kg ( T-only ) and 3.64 + /- 0.56 kg ( T + F ) vs. -0.21 + /- 0.55 kg for placebo ( P decreased fat mass , and significantly decreased total cholesterol , low-density lipoprotein , and leptin , without affecting high-density lipoprotein , adiponectin , or fasting insulin levels . These results demonstrate that T therapy in older men with low serum T improves physical performance and strength over 36 months , when administered alone or when combined with F , and suggest that high serum levels of dihydrotestosterone are not essential for these beneficial effects of T in men",
"We investigated the effects of 6 mo of near-physiological testosterone administration to older men on skeletal muscle function and muscle protein metabolism . Twelve older men ( > or = 60 yr ) with serum total testosterone concentrations were r and omly assigned in double-blind manner to receive either placebo ( n = 5 ) or testosterone enanthate ( TE ; n = 7 ) injections . Weekly intramuscular injections were given for the 1st mo to establish increased blood testosterone concentrations at 1 mo and then changed to biweekly injections until the 6-mo time point . TE doses were adjusted to maintain nadir serum testosterone concentrations between 17 and 28 nmol/l . Lean body mass ( LBM ) , muscle volume , prostate size , and urinary flow were measured at baseline and at 6 mo . Protein expression of and rogen receptor ( AR ) and insulin-like growth factor I , along with muscle strength and muscle protein metabolism , were measured at baseline and at 1 and 6 mo of treatment . Hematological parameters were followed monthly throughout the study . Older men receiving testosterone increased total and leg LBM , muscle volume , and leg and arm muscle strength after 6 mo . LBM accretion result ed from an increase in muscle protein net balance , due to a decrease in muscle protein breakdown . TE treatment increased expression of AR protein at 1 mo , but expression returned to pre-TE treatment levels by 6 mo . IGF-I protein expression increased at 1 mo and remained increased throughout TE administration . We conclude that physiological and near-physiological increases of testosterone in older men will increase muscle protein anabolism and muscle strength",
"objectives We have recently shown that , in men with erectile dysfunction ( ED ) , free testosterone ( FT ) directly correlates with penile arterial inflow . This led us to further investigate the effect(s ) of and rogen administration on cavernous arteries in patients failing sildenafil treatment",
"OBJECTIVES Older patients undergoing knee replacement surgery can recover more slowly than younger patients and require extended rehabilitation . Because administration of supraphysiological testosterone ( T ) dramatically increases strength , we hypothesized that preoperative T therapy would improve functional recovery and reduce hospital stay in older men undergoing knee replacement surgery . DESIGN Double-blinded , placebo-controlled pilot trial . SETTING A Veterans Affairs orthopedics clinic and inpatient postoperative unit . PARTICIPANTS Twenty-five men , mean age 70 , undergoing elective knee replacement . INTERVENTION Preoperative , supraphysiological T administration ( 600 mg T enanthate intramuscularly weekly for 4 weeks ) or sesame oil placebo . MEASUREMENTS Length of hospital stay and functional ability by Functional Independence Measure ( FIM ) score . RESULTS Mean length of hospital stay + /- st and ard deviation was nonsignificantly reduced in the T group ( 5.9 + /- 2.4 days vs 6.8 + /- 2.5 days ; P = .15 ) . At postoperative Day 3 , there was a significant improvement in ability to st and ( mean FIM score 5.2 + /- 1.0 vs 4.0 + /- 1.1 ; P = .04 ) and trends towards improvements in walking and stair climbing in the T group . There were no complications attributable to T therapy . CONCLUSIONS In older men undergoing knee replacement surgery , preoperative supraphysiological T administration may confer some clinical benefit . Future studies using longer courses of preoperative T administration in larger numbers of older men undergoing knee replacement surgery are warranted",
"A decline in testicular function is recognized as a common occurrence in older men . However data are sparse regarding the effects of hypogonadism on age-associated physical and cognitive declines . This study was undertaken to examine the year-long effects of testosterone administration in this patient population . Fifteen hypogonadal men ( mean age 68 + /- 6 yr ) were r and omly assigned to receive a placebo , and 17 hypogonadal men ( mean age 65 + /- 7 yr ) were r and omly assigned to receive testosterone . Hypogonadism was defined as a bioavailable testosterone placebo or 200 mg testosterone cypionate biweekly for 12 months . The main outcomes measured included grip strength , hemoglobin , prostate-specific antigen , leptin , and memory . Testosterone improved bilateral grip strength ( P hemoglobin ( P testosterone had greater decreases in leptin than those assigned to the control group ( mean + /- SEM : -2.0 + /- 0.9 ng/dL vs. 0.8 + /- 0.7 ng/dL ; P prostate-specific antigen or memory . Three subjects receiving placebo and seven subjects receiving testosterone withdrew from the study . Three of those seven withdrew because of an abnormal elevation in hematocrit . Testosterone supplementation improved strength , increased hemoglobin , and lowered leptin levels in older hypogonadal men . Testosterone may have a role in the treatment of frailty in males with hypogonadism ; however , older men receiving testosterone must be carefully monitored because of its potential risks",
"Muscle wasting in older men may be related to and rogen deficiency . We have assessed the effect of testosterone replacement therapy on muscle function in the upper and lower limbs of older ( age > 60 years ) men with blood testosterone levels received testosterone enanthate 200 mg i.m . or placebo every 2 weeks in a double blind study over a 12-week period and underwent muscle testing every 4 weeks . A significant increase in blood levels of testosterone and a reduction in levels of sex hormone binding globulin occurred in the treatment group . Total body mass , haemoglobin and packed cell volume also increased significantly ( p h and grip strength , isometric strength of knee flexors and extensors or leg extensor power were seen in either group . Wide variability in all measures of muscle function were observed in these elderly men suggesting that very large study groups would be required to determine potential treatment benefits on muscle function",
"Background : Low serum testosterone is associated with several cardiovascular risk factors including dyslipidaemia , adverse clotting profiles , obesity , and insulin resistance . Testosterone has been reported to improve symptoms of angina and delay time to ischaemic threshold in unselected men with coronary disease . Objective : This r and omised single blind placebo controlled crossover study compared testosterone replacement therapy ( Sustanon 100 ) with placebo in 10 men with ischaemic heart disease and hypogonadism . Results : Baseline total testosterone and bioavailable testosterone were respectively 4.2 ( 0.5 ) nmol/l and 1.7 ( 0.4 ) nmol/l . After a month of testosterone , delta value analysis between testosterone and placebo phase showed that mean ( SD ) trough testosterone concentrations increased significantly by 4.8 ( 6.6 ) nmol/l ( total testosterone ) ( p = 0.05 ) and 3.8 ( 4.5 ) nmol/l ( bioavailable testosterone ) ( p = 0.025 ) , time to 1 mm ST segment depression assessed by Bruce protocol exercise treadmill testing increased by 74 ( 54 ) seconds ( p = 0.002 ) , and mood scores assessed with vali date d question naires all improved . Compared with placebo , testosterone therapy was also associated with a significant reduction of total cholesterol and serum tumour necrosis factor α with delta values of −0.41 ( 0.54 ) mmol/l ( p = 0.04 ) and −1.8 ( 2.4 ) pg/ml ( p = 0.05 ) respectively . Conclusion : Testosterone replacement therapy in hypogonadal men delays time to ischaemia , improves mood , and is associated with potentially beneficial reductions of total cholesterol and serum tumour necrosis factor α ",
"PURPOSE Because the effects of and rogen replacement on lipoprotein levels are uncertain , we sought to determine the effect of transdermal testosterone treatment on serum lipid and apolipoprotein levels in elderly men . SUBJECTS AND METHODS One hundred and eight healthy men more than 65 years of age who had serum testosterone concentrations > 1 SD below the mean for young men were r and omly assigned to receive either testosterone ( 54 men ; 6 mg/day ) or placebo ( 54 men ) transdermally in a double-blind fashion for 36 months . Serum concentrations of lipids and apolipoproteins were measured , and cardiovascular events recorded . RESULTS Serum total cholesterol concentrations decreased in both the testosterone-treated men and placebo-treated men , but the 3-year mean ( + /- SD ) decreases in the two groups ( testosterone treated , -17 + /- 29 mg/dL ; placebo treated , -12 + /- 38 mg/dL ) were not significantly different from each other ( P = 0.4 ) . Similarly , serum low-density lipoprotein ( LDL ) cholesterol levels decreased in both treatment groups , but the decreases in the two groups ( testosterone treated , -16 + /- 24 mg/dL ; placebo treated , -16 + /- 33 mg/dL ) were similar ( P = 1.0 ) . Levels of high-density lipoprotein ( HDL ) cholesterol , triglycerides , and apolipoproteins A-I and B did not change . Lipoprotein(a ) levels increased in both groups by similar amounts ( testosterone treated , 3 + /- 9 mg/dL ; placebo treated , 4 + /- 6 mg/dL ; P = 1.0 ) . The number of cardiovascular events was small and did not differ significantly between the testosterone-treated men ( 9 events ) and the placebo-treated men ( 5 events ) during the 3-year study ( relative risk = 1.8 ; 95 % confidence interval : 0.7 to 5.0 ) . CONCLUSIONS As compared with placebo , transdermal testosterone treatment of healthy elderly men for 3 years did not affect any of the lipid or apolipoprotein parameters that we measured . The effect of testosterone treatment on cardiovascular events was unclear , because the number of events was small",
"BACKGROUND Loss of muscle mass ( sarcopenia ) leads to frailty in older men . The decline in testosterone over the life span may contribute to this muscle loss . We studied the ability of oral testosterone to prevent muscle loss in older men over a 12-month period . METHODS A st and ard dose ( 80 mg twice daily ) of testosterone undecanoate or placebo was administered for 1 year to 76 healthy men aged 60 years or older . All men had a free testosterone index of 0.3 - 0.5 , which represents a value below the normal lower limit for young men ( 19 - 30 years ) , but remains within the overall normal male range . Measurements of body composition , muscle strength , hormones , and safety parameters were obtained at 0 , 6 , and 12 months . RESULTS Lean body mass increased ( p = .0001 ) and fat mass decreased ( p = .02 ) in the testosterone as compared with the placebo-treated group . There were no significant effects on muscle strength . There was a significant increase in hematocrit ( 0.02 % ) in the testosterone-treated group ( p = .03 ) . Plasma triglycerides , total cholesterol , and low-density lipoprotein cholesterol levels were similar in both groups , but there was a decrease in high-density lipoprotein cholesterol ( -0.1 mmol/L ) at 12 months in the testosterone group as compared to the placebo group ( p = 0.026 ) . There were no differences in prostate-specific antigen or systolic or diastolic blood pressure between the groups . CONCLUSION Oral testosterone administration to older relatively hypogonadal men results in an increase in muscle mass and a decrease in body fat",
"The elevated estradiol/testosterone ( E2/T ) ratio had been proved to be a risk factor for coronary heart disease ( CHD ) in elderly males and to exert an adverse effect on lipid metabolism . We conducted a r and omized cross-over study to determine the effect of And riol , a new and rogenic preparation , on plasma lipids and apolipoproteins . The results showed a significant difference in most parameters between patients receiving And riol and the control group : in the former , serum T level was elevated significantly ( P E2 level was unchanged ( P > 0.05 ) and the E2/T ratio was reduced ( P > 0.05 ) . Blood levels of total cholesterol ( TC ) and triglyceride ( TG ) were lowered dramatically ( P high density lipoprotein cholesterol ( HDL-ch ) was raised ( P apolipoprotein-AI ( APO-AI ) and B ( APO-B ) levels remained unchanged . No obvious side effect was observed in those who took And riol",
"And rogen therapy may precipitate obstructive sleep apnea in men . Despite increasing and rogen use in older men , few studies have examined sleep and breathing . R and omized , double-blind , placebo-controlled studies examining effects of testosterone simultaneously on sleep , breathing , and function in older men are not available . Seventeen community-dwelling healthy men over the age of 60 yr were r and omized to receive three injections of i m testosterone esters at weekly intervals ( 500 mg , 250 mg , and 250 mg ) or matching oil-based placebo and then crossed over to the other treatment after 8 wk of washout . Polysomnography , anthropometry , and physical , mental , and metabolic function were assessed at baseline and after each treatment period . Testosterone treatment reduced total time slept ( approximately 1 h ) , increased the duration of hypoxemia ( approximately 5 min/night ) , and disrupted breathing during sleep ( total and non-rapid eye movement respiratory disturbance indices both increased by approximately seven events per hour ) ( all P body composition ( increase in total and lean mass , reduction in fat mass , P bioimpedance method ) , upper airway dimensions did not change ( acoustic reflectometry ) . Driving ability ( computer simulation ) , physical activity ( accelerometry , Physical Activity Scale in the Elderly ) , quality of life ( SF36 , Functional Outcomes of Sleep Question naire ) , mood ( Profile of Mood States Question naire ) , sleepiness ( Epworth , Stanford scales ) , and insulin resistance ( homeostasis model ) also were not changed by treatment . Short-term administration of high-dose testosterone shortens sleep and worsens sleep apnea in older men but did not alter physical , mental , or metabolic function . These changes did not appear to be due to upper airway narrowing . Further study of longer-term lower-dose and rogen therapy on sleep and breathing is needed to evaluate its safety in older men",
"OBJECTIVE Testosterone deficiency is associated with significant morbidity , and and rogen replacement in overt hypogonadism is clearly beneficial . However , there are few data concerning the response to therapy in young men with mild testosterone deficiency",
"The basis was established for a rational sex hormone therapy with the isolation of the estrogenicl 2 s and and rogenic hormones.3 It has been demonstrated by animal experiments that a basic effect of the sex hormones is hyperemization of the whole organism.4 4 When this observation was confirmed with regards to the skin in the 1930 ’s in patients treated for well defined gonad insufficiency , the possibility then existed of treating patients with diseases of the circulatory system with sex hormones ",
"The efficacy and safety of and rogen supplementation in older men remains controversial . Despite biochemical evidence of partial and rogen deficiency in older men , controlled studies using T demonstrate equivocal benefits . Furthermore , the importance of aromatization and 5alpha reduction in and rogen actions among older men remains unclear . Dihydrotestosterone is the highest potency natural and rogen with the additional features that it is neither aromatizable nor susceptible to potency amplification by 5alpha reduction . Therefore , the effects of dihydrotestosterone may differ from those of T in older men . This study evaluated the efficacy and safety of 3 months treatment with transdermal dihydrotestosterone gel on muscle strength , mobility , and quality of life in ambulant , community-dwelling men aged 60 yr or older . Eligible men ( plasma T were r and omized to undergo daily dermal application of 70 mg dihydrotestosterone gel ( n = 18 ) or vehicle ( n = 19 ) and were studied before , monthly during , and 1 month after treatment . Among 33 ( 17 dihydrotestosterone , 16 placebo ) men completing the study with a high degree of compliance , dihydrotestosterone had significant effects on circulating hormones ( increased dihydrotestosterone ; decreased total and free testosterone , LH , and FSH ; unchanged SHBG and estradiol ) , lipid profiles ( decreased total and low-density lipoprotein cholesterols ; unchanged high-density lipoprotein cholesterol and triglycerides ) , hematopoiesis ( increased hemoglobin , hematocrit , and red cell counts ) , and body composition ( decreased skinfold thickness and fat mass ; unchanged lean mass and waist to hip ratio ) . Muscle strength measured by isokinetic peak torque was increased in flexion of the dominant knee but not in knee extension or shoulder contraction , nor was there any significant change in gait , balance , or mobility tests , in cognitive function , or in quality of life scales . Dihydrotestosterone treatment had no adverse effects on prostate ( unchanged prostate volumes and prostate-specific antigen ) and cardiovascular ( no adverse change in vascular reactivity or lipids ) safety markers . We conclude that 3 months treatment with transdermal dihydrotestosterone gel demonstrates expected and rogenic effects , short-term safety , and limited improvement in lower limb muscle strength but no change in physical functioning or cognitive function"
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BACKGROUND There has been increased interest in early screening and intervention for young children with , or at risk of , autism spectrum disorder ( ASD ) . This has generated a debate about the potential harms versus benefits of early identification and treatment . This review aims to identify the evidence base for early intervention in ASD . METHODS A systematic review search ing for r and omised controlled trials ( RCTs ) of interventions for children up to 6 years of age with , or at risk of , ASD was undertaken . Characteristics and outcomes of included studies were collated and described in tabular format , and all included studies were rated according to the Cochrane Risk of Bias Tool . RESULTS Forty-eight RCTs were identified , of which 40 were published since 2010 . Most studies ( n = 34 ) were undertaken in the United States . Included RCTs evaluated 32 different models of intervention . If blinding of participants and relevant personnel is overlooked as a source of bias , only six studies met criteria for low risk of bias across all domains of the Cochrane Risk of Bias Tool . The majority of studies had a relatively small sample size with only seven studies having a sample size > 100 . CONCLUSIONS There has been a substantial increase in the number of RCTs evaluating early interventions in ASD . However , few studies , only 12.5 % of the total , were rated as being at low risk of bias . Small sample size , unclear concealment of allocation and lack of clarity in the identification of the active ingredients in a diverse range of differently named treatment models were identified as challenges to the design , conduct and interpretation of studies . Improved co-ordination and design of studies is , therefore , required if future research in the field is to more clearly investigate the effects of early intervention for ASD | [
"BACKGROUND Delays and deficits in joint attention and symbolic play constitute two important developmental problems in young children with autism . These areas of deficit have been well studied in autism but have rarely been the focus of treatment efforts ( see Kasari , Freeman , & Paparella , 2001 ) . In this study , we examine the efficacy of targeted interventions of joint attention and symbolic play . METHODS Participants were 58 children with autism aged 3 and 4 years ( 46 boys ) . Children were r and omized to a joint attention intervention , a symbolic play intervention , or control group . Interventions were conducted 30 minutes daily for 5 - 6 weeks . Both structured assessment s of joint attention and play skills and mother-child interactions were collected pre and post intervention by independent assessors . RESULTS Results indicate that both intervention groups improved significantly over the control group on certain behaviors . Children in the joint attention intervention initiated significantly more showing and responsiveness to joint attention on the structured joint attention assessment and more child-initiated joint attention in the mother-child interaction . The children in the play group showed more diverse types of symbolic play in interaction with their mothers and higher play levels on both the play assessment and in interaction with their mothers . CONCLUSIONS This r and omized controlled trial provides promising data on the specificity and generalizability of joint attention and play interventions for young children with autism . Future studies need to examine the long-term effects of these early interventions on children 's development",
"OBJECTIVE This study reports 12-month follow-up data from a r and omized controlled trial of preschool-based social communication treatment for young children with autism . METHOD A total of 61 children ( 48 males ) with autism , 29 to 60 months of age , had earlier been r and omized either to 8 weeks of preschool-based social communication treatment in addition to st and ard preschool program ( n = 34 ) or to st and ard preschool program only ( n = 27 ) . Significant short-term effects on targeted social communication skills have previously been published . Long-term gains in social communication , language and global social functioning and communication were assessed from video-taped preschool teacher-child and mother-child interactions , Early Social Communication Scales , Reynell Developmental Language Scale , and Social Communication Question naire . RESULTS Compared with those in the control group , the treated children achieved significantly larger improvements in joint attention and joint engagement from baseline to 12-month follow-up . However , no effects were detected on language and global ratings of social functioning and communication . The treatment effect on child initiation of joint attention increased with increasing level of sociability at baseline , whereas nonverbal IQ and expressive language had no moderating effect . CONCLUSIONS This study is the first to show that , similar to specialist-delivered treatment , preschool-based treatment may produce small but possibly clinical ly important long-term changes in social communication in young children with autism . The treatment did not affect language and global ratings of social functioning and communication . More studies are needed to better underst and whether treatment effects may be improved by increasing the intensity and duration of the treatment . Clinical trial registration information -- Joint Attention Intervention and Young Children With Autism ; http:// clinical trials.gov/ ; NCT00378157",
"This single subject design study examined two models of intervention : Denver Model ( which merges behavioral , developmental , and relationship-oriented intervention ) , and PROMPT ( a neuro-developmental approach for speech production disorders ) . Ten young , nonverbal children with autism were matched in pairs and r and omized to treatment . They received 12 1-h weekly sessions of therapy and daily 1-h home intervention delivered by parents . Fidelity criteria were maintained throughout . Eight of the ten children used five or more novel , functional words spontaneously and spoke multiple times per hour by the conclusion of treatment . There were no differences in acquired language skills by intervention group . Initial characteristics of the best responders were mild to moderate symptoms of autism , better motor imitation skills , and emerging joint attention skills",
"Background Although social skills training programs for people with high-functioning autism ( HFA ) are widely practice d , the st and ardization of curricula , the examination of clinical effectiveness , and the evaluation of the feasibility of future trials have yet to be done in Asian countries . To compensate for this problem , a Japanese pilot r and omized controlled trial ( RCT ) of the Treatment and Education of Autistic and Related Communication H and icapped Children (TEACCH)-based group social skills training for children with HFA and their mothers was conducted . Methods Eleven children with HFA , aged 5–6 years , and their mothers were r and omly assigned to the TEACCH program ( n=5 ) or a waiting-list control group ( n=6 ) . The program involved comprehensive group intervention and featured weekly 2-hour sessions , totaling 20 sessions over six months . The adaptive behaviors and social reciprocity of the children , parenting stress , and parent – child interactions were assessed using the Strengths and Difficulties Question naire ( SDQ ) , Parenting Stress Index ( PSI ) , Beck depression inventory-II ( BDI-II ) , and Interaction Rating Scale ( IRS ) . Results Through this pilot trial , the intervention and evaluation of the program has been shaped . There were no dropouts from the program and the mothers ’ satisfaction was high . The outcome measurements improved more in the program group than in the control group , with moderate effect sizes ( SDQ , 0.71 ; PSI , 0.58 ; BDI-II , 0.40 ; and IRS , 0.69 ) . This pilot trial also implied that this program is more beneficial for high IQ children and mothers with low stress than for those who are not . Conclusion We have st and ardized the TEACCH program , confirmed the feasibility of a future trial , and successfully estimated the positive effect size . These findings will contribute to a larger trial in the future and to forthcoming systematic review s with meta-analyses . Trial registration",
"Deficits in eye contact have been a hallmark of autism since the condition ’s initial description . They are cited widely as a diagnostic feature and figure prominently in clinical instruments ; however , the early onset of these deficits has not been known . Here we show in a prospect i ve longitudinal study that infants later diagnosed with autism spectrum disorders ( ASDs ) exhibit mean decline in eye fixation from 2 to 6 months of age , a pattern not observed in infants who do not develop ASD . These observations mark the earliest known indicators of social disability in infancy , but also falsify a prior hypothesis : in the first months of life , this basic mechanism of social adaptive action — eye looking — is not immediately diminished in infants later diagnosed with ASD ; instead , eye looking appears to begin at normative levels prior to decline . The timing of decline highlights a narrow developmental window and reveals the early derailment of processes that would otherwise have a key role in canalizing typical social development . Finally , the observation of this decline in eye fixation — rather than outright absence — offers a promising opportunity for early intervention that could build on the apparent preservation of mechanisms subserving reflexive initial orientation towards the eyes",
"We piloted a 2-week “ Autism-1 - 2 - 3 ” early intervention for children with autism and their parents immediately after diagnosis that targeted at ( 1 ) eye contact , ( 2 ) gesture and ( 3 ) vocalization/words . Seventeen children were r and omized into the Intervention ( n = 9 ) and Control ( n = 8) groups . Outcome measures included the Autism Diagnostic Observation Schedule , Ritvo-Freeman Real Life Rating Scale , Symbolic Play Test , and Parenting Stress Index . Children with autism improved in language /communication , reciprocal social interaction , and symbolic play . Parents perceived significant improvement in their children ’s language , social interaction , and their own stress level . This intervention can serve as short-term training on communication and social interaction for children with autism , and reduce the stress of their parents during the long waiting time for public health services",
"OBJECTIVE : To conduct a r and omized , controlled trial to evaluate the efficacy of the Early Start Denver Model ( ESDM ) , a comprehensive developmental behavioral intervention , for improving outcomes of toddlers diagnosed with autism spectrum disorder ( ASD ) . METHODS : Forty-eight children diagnosed with ASD between 18 and 30 months of age were r and omly assigned to 1 of 2 groups : ( 1 ) ESDM intervention , which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years ; or ( 2 ) referral to community providers for intervention commonly available in the community . RESULTS : Compared with children who received community-intervention , children who received ESDM showed significant improvements in IQ , adaptive behavior , and autism diagnosis . Two years after entering intervention , the ESDM group on average improved 17.6 st and ard score points ( 1 SD : 15 points ) compared with 7.0 points in the comparison group relative to baseline scores . The ESDM group maintained its rate of growth in adaptive behavior compared with a normative sample of typically developing children . In contrast , over the 2-year span , the comparison group showed greater delays in adaptive behavior . Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder , not otherwise specified , than the comparison group . CONCLUSIONS : This is the first r and omized , controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis . Results of this study underscore the importance of early detection of and intervention in autism",
"Children with autism exhibit significant deficits in imitation skills . Reciprocal Imitation Training ( RIT ) , a naturalistic imitation intervention , was developed to teach young children with autism to imitate during play . This study used a r and omized controlled trial to evaluate the efficacy of RIT on elicited and spontaneous imitation skills in 21 young children with autism . Results found that children in the treatment group made significantly more gains in elicited and spontaneous imitation , replicating previous single-subject design studies . Number of spontaneous play acts at pre-treatment was related to improvements in imitation during the intervention , suggesting that children with a greater play repertoire make greater gains during RIT",
"PURPOSE This r and omized group experiment compared the efficacy of 2 communication interventions ( Responsive Education and Prelinguistic Milieu Teaching [ RPMT ] and the Picture Exchange Communication System [ PECS ] ) on spoken communication in 36 preschoolers with autism spectrum disorders ( ASD ) . METHOD Each treatment was delivered to children for a maximum total of 24 hr over a 6-month period . Spoken communication was assessed in a rigorous test of generalization at pretreatment , posttreatment , and 6-month follow-up periods . RESULTS PECS was more successful than RPMT in increasing the number of nonimitative spoken communication acts and the number of different nonimitative words used at the posttreatment period . Considering growth over all 3 measurement periods , an exploratory analysis showed that growth rate of the number of different nonimitative words was faster in the PECS group than in the RPMT group for children who began treatment with relatively high object exploration . In contrast , analogous slopes were steeper in the RPMT group than in the PECS group for children who began treatment with relatively low object exploration",
"This study aim ed to determine if a joint attention intervention would result in greater joint engagement between caregivers and toddlers with autism . The intervention consisted of 24 caregiver-mediated sessions with follow-up 1 year later . Compared to caregivers and toddlers r and omized to the waitlist control group the immediate treatment ( IT ) group made significant improvements in targeted areas of joint engagement . The IT group demonstrated significant improvements with medium to large effect sizes in their responsiveness to joint attention and their diversity of functional play acts after the intervention with maintenance of these skills 1 year post-intervention . These are among the first r and omized controlled data to suggest that short-term parent-mediated interventions can have important effects on core impairments in toddlers with autism . Clinical Trials # : NCT00065910",
"Objective : To evaluate the effectiveness of the Play and Language for Autistic Youngsters ( PLAY ) Project Home Consultation model , in combination with usual community services ( CS ) , to improve parent-child interaction , child development , and autism symptomatology in young children with autism spectrum disorders ( ASDs ) compared with CS only . Methods : Children ( N = 128 ) with autism or PDD-NOS ( DSM-4 criteria ) aged 2 years 8 months to 5 years 11 months and recruited from 5 disability agencies in 4 US states were r and omized in two 1-year cohorts . Using videotape and written feedback within a developmental framework , PLAY consultants coached caregivers monthly for 12 months to improve caregiver-child interaction . CS included speech/ language and occupational therapy and public education services . Primary outcomes included change in parent-child interactions , language and development , and autism-related diagnostic category/symptoms . Secondary outcomes included parent stress and depression and home consultant fidelity . Data were collected pre- and post-intervention . Results : Using intent-to-treat analysis ( ITT ) , large treatment effects were evident for parent and child interactional behaviors on the Maternal and Child Behavior Rating Scales . Child language and developmental quotient did not differ over time by group , although functional development improved significantly . PLAY children improved in diagnostic categories on the Autism Diagnostic Observation Schedule ( ADOS ) . PLAY caregivers ' stress did not increase , and depressive symptomatology decreased . Home consultants administered the intervention with fidelity . Conclusions : PLAY intervention demonstrated substantial changes in parent-child interaction without increasing parents ' stress/depression . ADOS findings must be interpreted cautiously because results do not align with clinical experience . PLAY offers communities a relatively inexpensive effective intervention for children with ASD and their parents",
"Background There has been increasing interest in the potential for pre‐emptive interventions in the prodrome of autism , but little investigation as to their effect . Methods A two‐site , two‐arm assessor‐blinded r and omised controlled trial ( RCT ) of a 12‐session parent‐mediated social communication intervention delivered between 9 and 14 months of age ( Intervention in the British Autism Study of Infant Siblings‐Video Interaction for Promoting Positive Parenting ) , against no intervention . Fifty‐four infants ( 28 intervention , 26 nonintervention ) at familial risk of autism but not otherwise selected for developmental atypicality were assessed at 9‐month baseline , 15‐month treatment endpoint , and 27‐ and 39‐month follow‐up . Primary outcome : severity of autism prodromal symptoms , blind‐rated on Autism Observation Schedule for Infants or Autism Diagnostic Observation Schedule 2nd Edition across the four assessment points . Secondary outcomes : blind‐rated parent – child interaction and child language ; nonblind parent‐rated communication and socialisation . Prespecified intention‐to‐treat analysis combined estimates from repeated measures within correlated regressions to estimate the overall effect of the infancy intervention over time . Results Effect estimates in favour of intervention on autism prodromal symptoms , maximal at 27 months , had confidence intervals ( CIs ) at each separate time point including the None , but showed a significant overall effect over the course of the intervention and follow‐up period ( effect size [ ES ] = 0.32 ; 95 % CI 0.04 , 0.60 ; p = .026 ) . Effects on proximal intervention targets of parent nondirectiveness/synchrony ( ES = 0.33 ; CI 0.04 , 0.63 ; p = .013 ) and child attentiveness/communication initiation ( ES = 0.36 ; 95 % CI 0.04 , 0.68 ; p = .015 ) showed similar results . There was no effect on categorical diagnostic outcome or formal language measures . Conclusions Follow‐up to 3 years of the first RCT of a very early social communication intervention for infants at familial risk of developing autism has shown a treatment effect , extending 24 months after intervention end , to reduce the overall severity of autism prodromal symptoms and enhance parent – child dyadic social communication over this period . We highlight the value of extended follow‐up and repeat assessment for early intervention trials",
"Summary Background Results of small trials suggest that early interventions for social communication are effective for the treatment of autism in children . We therefore investigated the efficacy of such an intervention in a larger trial . Methods Children with core autism ( aged 2 years to 4 years and 11 months ) were r and omly assigned in a one-to-one ratio to a parent-mediated communication-focused ( Preschool Autism Communication Trial [ PACT ] ) intervention or treatment as usual at three specialist centres in the UK . Those assigned to PACT were also given treatment as usual . R and omisation was by use of minimisation of probability in the marginal distribution of treatment centre , age ( ≤42 months or > 42 months ) , and autism severity ( Autism Diagnostic Observation Schedule-Generic [ ADOS-G ] algorithm score 12–17 or 18–24 ) . Primary outcome was severity of autism symptoms ( a total score of social communication algorithm items from ADOS-G , higher score indicating greater severity ) at 13 months . Complementary secondary outcomes were measures of parent-child interaction , child language , and adaptive functioning in school . Analysis was by intention to treat . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N58133827 . Results 152 children were recruited . 77 were assigned to PACT ( London [ n=26 ] , Manchester [ n=26 ] , and Newcastle [ n=25 ] ) ; and 75 to treatment as usual ( London [ n=26 ] , Manchester [ n=26 ] , and Newcastle [ n=23 ] ) . At the 13-month endpoint , the severity of symptoms was reduced by 3·9 points ( SD 4·7 ) on the ADOS-G algorithm in the group assigned to PACT , and 2·9 ( 3·9 ) in the group assigned to treatment as usual , representing a between-group effect size of −0·24 ( 95 % CI −0·59 to 0·11 ) , after adjustment for centre , sex , socioeconomic status , age , and verbal and non-verbal abilities . Treatment effect was positive for parental synchronous response to child ( 1·22 , 0·85 to 1·59 ) , child initiations with parent ( 0·41 , 0·08 to 0·74 ) , and for parent-child shared attention ( 0·33 , −0·02 to 0·68 ) . Effects on directly assessed language and adaptive functioning in school were small . Interpretation On the basis of our findings , we can not recommend the addition of the PACT intervention to treatment as usual for the reduction of autism symptoms ; however , a clear benefit was noted for parent-child dyadic social communication . Funding UK Medical Research Council , and UK Department for Children , Schools and Families",
"BACKGROUND With rates of autism diagnosis continuing to rise , there is an urgent need for effective and efficient service delivery models . Pivotal Response Treatment ( PRT ) is considered an established treatment for autism spectrum disorder ( ASD ) ; however , there have been few well-controlled studies with adequate sample size . The aim of this study was to conduct a r and omized controlled trial to evaluate PRT parent training group ( PRTG ) for targeting language deficits in young children with ASD . METHODS Fifty-three children with autism and significant language delay between 2 and 6 years old were r and omized to PRTG ( N = 27 ) or psychoeducation group ( PEG ; N = 26 ) for 12 weeks . The PRTG taught parents behavioral techniques to facilitate language development . The PEG taught general information about ASD ( clinical trial NCT01881750 ; http://www . clinical trials.gov ) . RESULTS Analysis of child utterances during the structured laboratory observation ( primary outcome ) indicated that , compared with children in the PEG , children in the PRTG demonstrated greater improvement in frequency of utterances ( F(2 , 43 ) = 3.53 , p = .038 , d = 0.42 ) . Results indicated that parents were able to learn PRT in a group format , as the majority of parents in the PRTG ( 84 % ) met fidelity of implementation criteria after 12 weeks . Children also demonstrated greater improvement in adaptive communication skills ( Vinel and -II ) following PRTG and baseline Mullen visual reception scores predicted treatment response to PRTG . CONCLUSIONS This is the first r and omized controlled trial of group-delivered PRT and one of the largest experimental investigations of the PRT model to date . The findings suggest that specific instruction in PRT results in greater skill acquisition for both parents and children , especially in functional and adaptive communication skills . Further research in PRT is warranted to replicate the observed results and address other core ASD symptoms",
"Summary Background Risk markers for later autism identified in the first year of life present plausible intervention targets during early development . We aim ed to assess the effect of a parent-mediated intervention for infants at high risk of autism on these markers . Methods We did a two-site , two-arm assessor-blinded r and omised controlled trial of families with an infant at familial high risk of autism aged 7–10 months , testing the adapted Video Interaction to Promote Positive Parenting ( iBASIS-VIPP ) versus no intervention . Families were r and omly assigned to intervention or no intervention groups using a permuted block approach stratified by centre . Assessors , but not families or therapists , were masked to group assignment . The primary outcome was infant attentiveness to parent . Regression analysis was done on an intention-to-treat basis . This trial is registered with ISCRTN Registry , number IS RCT N87373263 . Findings We r and omly assigned 54 families between April 11 , 2011 , and Dec 4 , 2012 ( 28 to intervention , 26 to no intervention ) . Although CIs sometimes include the None , point estimates suggest that the intervention increased the primary outcome of infant attentiveness to parent ( effect size 0·29 , 95 % CI −0·26 to 0·86 , thus including possibilities ranging from a small negative treatment effect to a strongly positive treatment effect ) . For secondary outcomes , the intervention reduced autism-risk behaviours ( 0·50 , CI −0·15 to 1·08 ) , increased parental non-directiveness ( 0·81 , 0·28 to 1·52 ) , improved attention disengagement ( 0·48 , −0·01 to 1·02 ) , and improved parent-rated infant adaptive function ( χ2[2 ] 15·39 , p=0·0005 ) . There was a possibility of nil or negative effect in language and responsivity to vowel change ( P1 : ES–0·62 , CI −2·42 to 0·31 ; P2 : −0·29 , −1·55 to 0·71 ) . Interpretation With the exception of the response to vowel change , our study showed positive estimates across a wide range of behavioural and brain function risk-markers and developmental outcomes that are consistent with a moderate intervention effect to reduce the risk for later autism . However , the estimates have wide CIs that include possible nil or small negative effects . The results are encouraging for development and prevention science , but need larger-scale replication to improve precision . Funding Autistica , Waterloo Foundation , Autism Speaks , and the UK Medical Research Council",
"Twenty-four children with autism were r and omly assigned to a clinic-directed group , replicating the parameters of the early intensive behavioral treatment developed at UCLA , or to a parent-directed group that received intensive hours but less supervision by equally well-trained supervisors . Outcome after 4 years of treatment , including cognitive , language , adaptive , social , and academic measures , was similar for both groups . After combining groups , we found that 48 % of all children showed rapid learning , achieved average posttreatment scores , and at age 7 , were succeeding in regular education classrooms . Treatment outcome was best predicted by pretreatment imitation , language , and social responsiveness . These results are consistent with those reported by Lovaas and colleagues ( Lovaas , 1987 ; McEachin , Smith , & Lovaas , 1993 )",
"OBJECTIVE This study was carried out to examine the efficacy of a 12-week , low-intensity ( 1-hour/wk of therapist contact ) , parent-delivered intervention for toddlers at risk for autism spectrum disorders ( ASD ) aged 14 to 24 months and their families . METHOD A r and omized controlled trial involving 98 children and families was carried out in three different sites investigating the efficacy of a parent delivery of the Early Start Denver model ( P-ESDM ) , which fosters parental use of a child-centered responsive interaction style that embeds many teaching opportunities into play , compared to community treatment as usual . Assessment s were completed at baseline and 12 weeks later , immediately after the end of parent coaching sessions . RESULTS There was no effect of group assignment on parent-child interaction characteristics or on any child outcomes . Both groups of parents improved interaction skills , and both groups of children demonstrated progress . Parents receiving P-ESDM demonstrated significantly stronger working alliances with their therapists than did the community group . Children in the community group received significantly more intervention hours than those in the P-ESDM group . For the group as a whole , both younger child age at the start of intervention and a greater number of intervention hours were positively related to the degree of improvement in children 's behavior for most variables . CONCLUSIONS Parent-implemented intervention studies for early ASD thus far have not demonstrated the large effects seen in intensive-treatment studies . Evidence that both younger age and more intervention hours positively affect developmental rates has implication s for clinical practice , service delivery , and public policy",
"BACKGROUND This r and omized controlled trial compared Hanen 's ' More than Words ' ( HMTW ) , a parent-implemented intervention , to a ' business as usual ' control group . METHODS Sixty-two children ( 51 boys and 11 girls ; M age = 20 months ; SD = 2.6 ) who met criteria for autism spectrum disorders ( ASD ) and their parents participated in the study . The HMTW intervention was provided over 3.5 months . There were three measurement periods : prior to r and omization ( Time 1 ) and at 5 and 9 months post enrollment ( Times 2 and 3 ) . Children 's communication and parental responsivity were measured at each time point . Children 's object interest , a putative moderator , was measured at Time 1 . RESULTS There were no main effects of the HMTW intervention on either parental responsivity or children 's communication . However , the effects on residualized gains in parental responsivity from Time 1 to both Times 2 and 3 yielded noteworthy effect sizes ( Glass 's Δ = .71 , .50 respectively ) . In contrast , there were treatment effects on child communication gains to Time 3 that were moderated by children 's Time 1 object interest . Children with lower levels of Time 1 object interest exhibited facilitated growth in communication ; children with higher levels of object interest exhibited growth attenuation . CONCLUSIONS The HMTW intervention showed differential effects on child communication depending on a baseline child factor . HMTW facilitated communication in children with lower levels of Time 1 object interest . Parents of children who evidence higher object interest may require greater support to implement the HMTW strategies , or may require different strategies than those provided by the HMTW curriculum",
"This study examined the ( a ) feasibility of enrolling 12-month-olds at risk of ASD from a community sample into a r and omized controlled trial , ( b ) subsequent utilization of community services , and ( c ) potential of a novel parent-mediated intervention to improve outcomes . The First Year Inventory was used to screen and recruit 12-month-old infants at risk of ASD to compare the effects of 6–9 months of Adapted Responsive Teaching ( ART ) versus referral to early intervention and monitoring ( REIM ) . Eighteen families were followed for ~20 months . Assessment s were conducted before r and omization , after treatment , and at 6-month follow-up . Utilization of community services was highest for the REIM group . ART significantly outperformed REIM on parent-reported and observed measures of child receptive language with good linear model fit . Multiphase growth models had better fit for more variables , showing the greatest effects in the active treatment phase , where ART outperformed REIM on parental interactive style ( less directive ) , child sensory responsiveness ( less hyporesponsive ) , and adaptive behavior ( increased communication and socialization ) . This study demonstrates the promise of a parent-mediated intervention for improving developmental outcomes for infants at risk of ASD in a community sample and highlights the utility of earlier identification for access to community services earlier than st and ard practice",
"OBJECTIVES : To compare 2 short-term , community caregiver training interventions for preschool-aged children with Autism Spectrum Disorder who had low re sources . Low re source was defined by the US Department of Housing and Urban Development low-income index or 1 “ indicator , ” ( eg , Medicaid eligibility ) . Child outcomes focused on joint engagement , joint attention , and play . METHODS : Participants included 112 families of a child who had Autism Spectrum Disorder who met criteria for being low-re source d and who were r and omly assigned to 1 of 2 3-month interventions , group caregiver education or individualized caregiver-mediated intervention ( CMM ) . Children were assessed for social communication skills pre- and post-treatment , and followed up at 3 months . RESULTS : All children improved in joint engagement and initiating joint attention , with significantly greater improvement by the CMM group . Outcomes on play skills were mixed , with improvement of symbolic play for the CMM group and no change in functional play skills . Joint engagement maintained over time for the CMM group , and initiating joint attention maintained for both groups over time . CONCLUSIONS : This study is among the first r and omized trials comparing 2 active interventions with a large sample of low-re source d families . Results suggest improvements in core autism deficits of joint engagement , joint attention , and symbolic play with relatively brief , caregiver-mediated interventions , but additional support is necessary to maintain and generalize these gains over time",
"There have been few large r and omised controlled trials of early intervention for children with autism spectrum disorder , even fewer with follow-up data , and none with such a lengthy follow-up period as that reported by And rew Pickles and colleagues 1 in The Lancet . These research ers assessed long-term outcomes for children who had received a parent-mediated intervention versus treatment as usual nearly 6 years earlier . That earlier study from 2010 2 was notable for its rigorous methodology . 3 The present follow-up study is also worthy of note . To appreciate its importance , some background is needed on the 2010 study . That study was a large r and omised controlled trial in which young children ( aged from 2 years to 4 years and 11 months ) were assigned to receive treatment as usual ( n=75 ) or treatment as usual plus the manual-based PreSchool Autism Communication Trial ( PACT ) programme ( n=77 ) . The PACT intervention is grounded in developmental principles and aims to increase parent sensitivity and responsiveness to child communication through various strategies such as improving parent observation , responsiveness , and focused communication . Compared with other early intervention approaches for young children with autism , 4–6 the PACT intervention reported in 2010 was a relatively low-intensity programme . Parents received 2 h clinical sessions every 2 weeks for the fi rst 6 months , followed by monthly booster sessions during the fi nal 6 months . Parents were also asked to implement their newly acquired sensitivity and responsivity skills at home for 20–30 min each day . The treatment eff ect was initially viewed as modest , 2 but the up date d analysis reported in this follow-up study 1 reveals greater improvements in the intervention group than in the treatment-as-usual group . The improvements seen from the initial PACT trial are consistent with results from other r and omised controlled trials of early autism interventions . 4–6 The follow-up study 1 sought to establish the long-term durability of these initial treatment gains . Follow-up was done at 5·75 years after the trial endpoint and included nearly 80 % of the original sample . The result ing data , which were analysed with repeated measures approaches , showed sustained treatment eff ects . Specifi cally , the severity of autism symptoms was signifi cantly lower for children in the intervention group than for children in the treatment-as-usual group . These diff erences were evident at the trial endpoint and at this 5·75 year follow-up . Secondary analyses showed that changes in social communication and restricted and repetitive behaviour , which are the two core",
"OBJECTIVES : To compare the effects of two 9-month parent-implemented interventions within the Early Social Interaction ( ESI ) Project . Both individual-ESI , offered 2 or 3 times per week at home or in the community , and group-ESI , offered once per week in a clinic , taught parents how to embed strategies to support social communication throughout everyday activities . METHODS : Participants in the r and omized controlled trial included 82 children diagnosed with autism spectrum disorder at 16 to 20 months . Children were matched on pretreatment nonverbal developmental level and pairs were r and omly assigned to treatment condition . Child outcomes included measures of social communication , autism symptoms , adaptive behavior , and developmental level . Child outcomes are reported from baseline to the end of the 9-month interventions . RESULTS : Children in individual-ESI showed differential change on a st and ardized examiner-administered observational measure of social communication , as they improved at a faster rate than children in group-ESI . Individual-ESI also showed differential efficacy on a parent report measure of communication , daily living , and social skills , as they showed improvement or stability , whereas group-ESI led to worsening or no significant change on these skills . Finally , individual-ESI showed differential change on examiner-administered measures of receptive language skills , as children in individual-ESI improved significantly , whereas group-ESI showed no change . CONCLUSIONS : These findings support the efficacy of individual-ESI compared with group-ESI on child outcomes , suggesting the importance of individualized parent coaching in natural environments . The efficacy of a parent-implemented intervention using little professional time has potential for community viability , which is particularly important in light of the lack of main effects on child outcomes of most other parent-implemented interventions",
"This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a r and omised controlled trial . Participants were 54 children aged under 6 years with a diagnosis of autism , assigned to either intervention or control conditions . The app engaged children , who played consistently , regardless of developmental level , and was rated highly by parents . There were no significant group differences in parent-report measures post-intervention , nor in a measure of parent – child play at follow-up . Therefore , this intervention did not have an observable impact on real-world social communication skills and caution is recommended about the potential usefulness of iPad ™ apps for amelioration of difficulties in interaction . However , positive attitudes among participants , lack of harms and the potential of apps to deliver therapeutic content at low economic cost suggest this approach is worth pursuing further , perhaps targeting other skill domains",
"OBJECTIVE The vast majority of children with an autism spectrum disorder ( ASD ) attend public preschools at some point in their childhood . Community preschool practice s often are not evidence based , and almost none target the prelinguistic core deficits of ASD . This study investigated the effectiveness of public preschool teachers implementing a vali date d intervention ( the Joint Attention and Symbolic Play/Engagement and Regulation intervention ; JASP/ER ) on a core deficit of autism , initiating joint attention . METHOD Sixteen dyads ( preschoolers with ASD and the public school teachers who worked in the child 's classroom ) were r and omly assigned to the 6-week JASP/ER intervention or a control group . RESULTS At the end of the intervention , JASP/ER teachers used more JASP/ER strategies than the control teachers , and JASP/ER preschoolers used more joint attention in their classroom than control children . Additionally , JASP/ER children spent more time in supported engagement and less time in object engagement than control preschoolers on a taped play interaction . CONCLUSIONS Findings suggest that teachers were able to improve a core deficit of children with ASD in a public preschool context ",
"Research on the expression of positive affect in young children with Autism Spectrum Disorder ( ASD ) suggests that differences in this domain emerge late in the first year or early in the second year . However , many previous studies in this area employed retrospective research methods and global rating schemes . In the current study , the expression of positive affect was examined prospect ively at ages 6 , 12 , and 18 months in three groups : infant siblings with ASD , infant siblings without ASD , and low-risk comparison infants . Infant siblings were the younger brothers or sisters of children diagnosed with ASD and , therefore , had a higher familial risk of ASD . The frequency and duration of smiles were coded from video excerpts from the Autism Observation Scale for Infants ( Bryson , Zwaigenbaum , McDermott , Rombough , and Brian 2008 ) , a st and ardized , play-based assessment of early signs of ASD . Results indicated that at 12 months , infant siblings with ASD had a lower rate of smiling than the other two groups . At 18 months , infant siblings with ASD continued to display a lower rate of smiling than infant siblings without ASD , but not comparison infants . Overall , these results indicate that infant siblings with ASD demonstrate less positive affect than infant siblings without ASD and low-risk comparison infants at 12 months . This suggests that reduced smiling may be an informative behavioural risk marker for ASD by children ’s first birthdays and may have implication s for our underst and ing of atypical social development in children with ASD ",
"This prospect i ve study examined object exploration behavior in 66 12-month-old infants , of whom nine were subsequently diagnosed with an autism spectrum disorder . Previous investigations differ on when the repetitive behaviors characteristic of autism are first present in early development . A task was developed that afforded specific opportunities for a range of repetitive uses of objects and was coded blind to outcome status . The autism/ASD outcome group displayed significantly more spinning , rotating , and unusual visual exploration of objects than two comparison groups . The average unusual visual exploration score of the autism/ASD group was over four st and ard deviations above the mean of the group with no concerns at outcome . Repetitive behaviors at 12 months were significantly related to cognitive and symptomatic status at 36 month outcome . These results suggest that repetitive or stereotyped behaviors may be present earlier than initially thought in very young children developing the autism phenotype",
"& NA ; This study reports on the results of a r and omized controlled trial that evaluated a caregiverbased intervention program for children with autism in community day‐care centers . Thirty‐five preschool children with a DSM III‐R diagnosis of autism or pervasive developmental disorder were r and omized to an experimental or control group . Children in the experimental group were enrolled in day care and their parents and child care workers received a 12‐week intervention consisting of lectures and on‐site consultations to day‐care centers . In addition , supportive work was undertaken with families . Control subjects received day care alone . In the experimental group , there were greater gains in language abilities , significant increases in caregivers ' knowledge about autism , greater perception of control on the part of mothers , and greater parent satisfaction . We conclude that this research design demonstrated that the intervention was significantly superior to day care alone",
"BACKGROUND Behavioral interventions are commonplace in the treatment of autism spectrum disorders , yet relatively little is known about how and why these interventions work . This study tests the relationship between isolated core components of a packaged social communication intervention and the primary outcome , joint engagement , to better underst and how the intervention is affecting change in individuals . METHODS A total of 86 toddlers and their parents were enrolled in the study and r and omized to one of two treatments , the joint attention , symbolic play , engagement , and regulation ( JASPER ) parent-mediated intervention or a psychoeducational intervention . Measures regarding the parent 's use of intervention strategies were collected before and after the 10-week intervention . Additional measures of child and parent joint engagement were also collected . RESULTS A significant effect of treatment was found for all four of the core strategies of the intervention , favoring a larger increase in the JASPER condition . A hierarchical linear regression revealed several individual predictors of joint engagement , including parent-rated buy-in , interventionist-rated parent involvement , and parental use of strategies . To complement the hierarchical analysis , we also tested the potential mediating effect the strategies may have on the relationship between treatment and joint engagement . Results showed that the strategy of mirrored pacing mediated the relationship between treatment and joint engagement in the positive direction . CONCLUSIONS These results strongly suggest that the mirrored pacing strategy is an active ingredient of the JASPER treatment",
"This study tested the effects of a parent-mediated intervention on parental responsiveness with their toddlers at high risk for an autism spectrum disorder ( ASD ) . Participants included caregivers and their 66 toddlers at high risk for ASD . Caregivers were r and omized to 12 sessions of an individualized parent education intervention aim ed at improving parental responsiveness or to a monitoring control group involving 4 sessions of behavioral support . Parental responsiveness and child outcomes were measured at three time points : at beginning and end of the 3-month treatment and at 12-months post- study entry . Parental responsiveness improved significantly in the treatment group but not the control group . However , parental responsiveness was not fully maintained at follow up . There were no treatment effects on child outcomes of joint attention or language . Children in both groups made significant developmental gains in cognition and language skills over one year . These results support parental responsiveness as an important intervention target given its general association with child outcomes in the extant literature ; however , additional supports are likely needed to fully maintain the treatment effect and to affect child outcomes",
"Presently there is no consensus on the specific behavioral treatment of choice for targeting language in young nonverbal children with autism . This r and omized clinical trial compared the effectiveness of a verbally-based intervention , Pivotal Response Training ( PRT ) to a pictorially-based behavioral intervention , the Picture Exchange Communication System ( PECS ) on the acquisition of spoken language by young ( 2–4 years ) , nonverbal or minimally verbal ( ≤9 words ) children with autism . Thirty-nine children were r and omly assigned to either the PRT or PECS condition . Participants received on average 247 h of intervention across 23 weeks . Dependent measures included overall communication , expressive vocabulary , pictorial communication and parent satisfaction . Children in both intervention groups demonstrated increases in spoken language skills , with no significant difference between the two conditions . Seventy-eight percent of all children exited the program with more than 10 functional words . Parents were very satisfied with both programs but indicated PECS was more difficult to implement",
"This r and omized , controlled trial , comparing the Comprehensive Autism Program ( CAP ) and business as usual programs , studied outcomes for 3–5 year old students with autism spectrum disorder ( ASD ) . Participants included 84 teachers and 302 students with ASD and their parents . CAP utilized specialized curricula and training components to implement specific evidence -based practice s both at school and home . A comprehensive set of outcome areas was studied . Hierarchical linear modeling was used to estimate the treatment impact . CAP had small positive impacts on the students ’ receptive language ( effect size of .13 ) and on their social skills as rated by teachers ( effect size of .19 ) . Treatment effects were moderated by severity of ASD",
"OBJECTIVE We prospect ively examined evidence for the sustained effects of early intervention based on a follow-up study of 39 children with ASD who began participation in a r and omized clinical trial testing the effectiveness of the Early Start Denver Model ( ESDM ) at age 18 to 30 months . The intervention , conducted at a high level of intensity in-home for 2 years , showed evidence of efficacy immediately posttreatment . METHOD This group of children was assessed at age 6 years , 2 years after the intervention ended , across multiple domains of functioning by clinicians naive to previous intervention group status . RESULTS The ESDM group , on average , maintained gains made in early intervention during the 2-year follow-up period in overall intellectual ability , adaptive behavior , symptom severity , and challenging behavior . No group differences in core autism symptoms were found immediately posttreatment ; however , 2 years later , the ESDM group demonstrated improved core autism symptoms and adaptive behavior as compared with the community-intervention-as-usual ( COM ) group . The 2 groups were not significantly different in terms of intellectual functioning at age 6 years . Both groups received equivalent intervention hours during the original study , but the ESDM group received fewer hours during the follow-up period . CONCLUSION These results provide evidence that gains from early intensive intervention are maintained 2 years later . Notably , core autism symptoms improved in the ESDM group over the follow-up period relative to the COM group . This improvement occurred at the same time that the ESDM group received significantly fewer services . This is the first study to examine the role of early ESDM behavioral intervention initiated at less than 30 months of age in altering the longer-term developmental course of autism",
"OBJECTIVE To explore the short-term treatment effect of the auditory integrative training on autistic children and provide them with clinical support for rehabilitative treatment . METHODS A total of 81 cases of autistic children were selected through the st and ard of DSM-4 and clinical case study was used . They were divided r and omly into experimental group and control one , and respectively received auditory integrative training and no training based on the multiple therapies . The patients were investigated using clinical manifestation and Autism Behavior Checklist ( ABC ) and intelligence quotient ( IQ ) before and after six months of treatment . The effect was evaluated through the changes of clinical manifestations and scores of ABC and IQ . The changes of scores of IQ were determined with Gesell and WPPSI or WISC-R. RESULTS Compared with 40 patients of the control group after the six months of the auditory integrative training , 41 of the experimental group had greatly improved in many aspects , such as the disorders of their language , social interactions and typical behavior symptoms while they had not changed in their abnormal behaviors . The scores of IQ or DQ had increased and scores of ABC had dropped . The differences between the two groups were greatly significant in statistics ( P both ABC scores and the increasing level of the IQ scores were negatively correlated with age , and the decreasing level of ABC scores was in line regression(positive correlation ) with base IQ . CONCLUSION The treatment of auditory integrative training ( AIT ) could greatly improve on language disorders , the difficulties of social interactions , typical behavior symptoms and developmental levels , therefore it is positive to the autistic children in its short-term treatment effect",
"The study compared the effect of music training , speech training and no-training on the verbal production of children with Autism Spectrum Disorders ( ASD ) . Participants were 50 children with ASD , age range 3 to 5 years , who had previously been evaluated on st and ard tests of language and level of functioning . They were r and omly assigned to one of three 3-day conditions . Participants in music training ( n = 18 ) watched a music video containing 6 songs and pictures of the 36 target words ; those in speech training ( n = 18 ) watched a speech video containing 6 stories and pictures , and those in the control condition ( n = 14 ) received no treatment . Participants ' verbal production including semantics , phonology , pragmatics , and prosody was measured by an experimenter design ed verbal production evaluation scale . Results showed that participants in both music and speech training significantly increased their pre to posttest verbal production . Results also indicated that both high and low functioning participants improved their speech production after receiving either music or speech training ; however , low functioning participants showed a greater improvement after the music training than the speech training . Children with ASD perceive important linguistic information embedded in music stimuli organized by principles of pattern perception , and produce the functional speech",
"Few research -developed early intervention models have been deployed to and tested in real world preschool programs . In this study , teaching staff implemented a social communication modularized intervention , JASPER , in their daily program . Sixty-six preschool children with autism in twelve classrooms ( 12 teachers ) were r and omized to receive immediate JASPER training ( IT ) or were waitlisted ( WL ) for 3 months with a 1-month follow up . Measures of core deficits ( initiations of joint engagement , joint attention gestures and language , play skills ) and st and ardized cognitive measures were improved for IT over WL children . IT teachers achieved and maintained high fidelity . Teachers can implement evidence -based interventions with significant improvements in core deficits of their children with ASD",
"BACKGROUND Psychosocial treatments are the mainstay of management of autism in the UK but there is a notable lack of a systematic evidence base for their effectiveness . R and omised controlled trial ( RCT ) studies in this area have been rare but are essential because of the developmental heterogeneity of the disorder . We aim ed to test a new theoretically based social communication intervention targeting parental communication in a r and omised design against routine care alone . METHODS The intervention was given in addition to existing care and involved regular monthly therapist contact for 6 months with a further 6 months of 2-monthly consolidation sessions . It aim ed to educate parents and train them in adapted communication tailored to their child 's individual competencies . Twenty-eight children with autism were r and omised between this treatment and routine care alone , stratified for age and baseline severity . Outcome was measured at 12 months from commencement of intervention , using st and ardised instruments . RESULTS All cases studied met full Autism Diagnostic Interview ( ADI ) criteria for classical autism . Treatment and controls had similar routine care during the study period and there were no study dropouts after treatment had started . The active treatment group showed significant improvement compared with controls on the primary outcome measure -- Autism Diagnostic Observation Schedule ( ADOS ) total score , particularly in reciprocal social interaction-- and on secondary measures of expressive language , communicative initiation and parent-child interaction . Suggestive but non-significant results were found in Vinel and Adaptive Behaviour Scales ( Communication Sub-domain ) and ADOS stereotyped and restricted behaviour domain . CONCLUSIONS A R and omised Treatment Trial design of this kind in classical autism is feasible and acceptable to patients . This pilot study suggests significant additional treatment benefits following a targeted ( but relatively non-intensive ) dyadic social communication treatment , when compared with routine care . The study needs replication on larger and independent sample s. It should encourage further RCT design s in this area",
"Aim : To determine the effect of parent education on adaptive behaviour , autism symptoms and cognitive/ language skills of young children with autistic disorder . Method : A r and omised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent skills training and a control sample . Two rural and two metropolitan regions were r and omly allocated to intervention groups ( n = 70 ) or control ( n = 35 ) . Parents from autism assessment services in the intervention regions were r and omly allocated to parent education and behaviour management ( n = 35 ) or parent education and counselling ( n = 35 ) . Results : Parent education and behaviour management result ed in significant improvement in adaptive behaviour and autism symptoms at 6 months follow-up for children with greater delays in adaptive behaviour . Parent education and behaviour management was superior to parent education and counselling . We conclude that a 20-week parent education programme including skills training for parents of young children with autistic disorder provides significant improvements in child adaptive behaviour and symptoms of autism for low-functioning children",
"BACKGROUND Social and communication impairments are core deficits and prognostic indicators of autism . We evaluated the impact of supplementing a comprehensive intervention with a curriculum targeting socially synchronous behavior on social outcomes of toddlers with autism spectrum disorders ( ASD ) . METHODS Fifty toddlers with ASD , ages 21 to 33 months , were r and omized to one of two six-month interventions : Interpersonal Synchrony or Non-Interpersonal Synchrony . The interventions provided identical intensity ( 10 hours per week in classroom ) , student-to-teacher ratio , schedule , home-based parent training ( 1.5 hours per month ) , parent education ( 38 hours ) , and instructional strategies , except the Interpersonal Synchrony condition provided a supplementary curriculum targeting socially engaged imitation , joint attention , and affect sharing ; measures of these were primary outcomes . Assessment s were conducted pre-intervention , immediately post-intervention , and , to assess maintenance , at six-month follow-up . R and om effects models were used to examine differences between groups over time . Secondary analyses examined gains in expressive language and nonverbal cognition , and time effects during the intervention and follow-up periods . RESULTS A significant treatment effect was found for socially engaged imitation ( p = .02 ) , with more than doubling ( 17 % to 42 % ) of imitated acts paired with eye contact in the Interpersonal Synchrony group after the intervention . This skill was generalized to unfamiliar context s and maintained through follow-up . Similar gains were observed for initiation of joint attention and shared positive affect , but between-group differences did not reach statistical significance . A significant time effect was found for all outcomes ( p toddlers to identify an active ingredient for enhancing socially engaged imitation . Adding social engagement targets to intervention improves short-term outcome at no additional cost to the intervention . The social , language , and cognitive gains in our participants provide evidence for plasticity of these developmental systems in toddlers with ASD . http://www . clinical trials.gov/ct2/show/NCT00106210?term = l and a&rank = 3",
"In this pilot study , we tested the effects of a novel intervention ( JASPER , Joint Attention Symbolic Play Engagement and Regulation ) on 3 to 5 year old , minimally verbal children with autism who were attending a non-public preschool . Participants were r and omized to a control group ( treatment as usual , 30 h of ABA-based therapy per week ) or a treatment group ( substitution of 30 min of JASPER treatment , twice weekly during their regular program ) . A baseline of 12 weeks in which no changes were noted in core deficits was followed by 12 weeks of intervention for children r and omized to the JASPER treatment . Participants in the treatment group demonstrated greater play diversity on a st and ardized assessment . Effects also generalized to the classroom , where participants in the treatment group initiated more gestures and spent less time unengaged . These results provide further support that even brief , targeted interventions on joint attention and play can improve core deficits in minimally verbal children with ASD",
"BACKGROUND Interventions found to be effective in research setting s are often not as effective when implemented in community setting s. Considering children with autism , studies have rarely examined the efficacy of laboratory-tested interventions on child outcomes in community setting s using r and omized controlled design s. METHODS One hundred and thirteen children with autism enrolled in public early intervention classrooms in low re source neighborhoods were r and omized to Joint Attention , Symbolic Play , Engagement , and Regulation ( JASPER ) intervention or treatment as usual waitlist for 10 weeks with 1-month follow-up . RESULTS Teaching assistants delivered JASPER at adequate fidelity . Children r and omized to JASPER demonstrated significant gains over treatment as usual in core developmental outcomes of joint engagement , joint attention , and play skills that were maintained at follow-up . CONCLUSIONS Supervised teaching assistants delivered JASPER intervention with a range of toddlers with autism leading to significant gains in developmental outcomes",
"The study evaluates a social-communication-based approach to autism intervention aim ed at improving the social interaction skills of children with autism spectrum disorder . We report preliminary results from an ongoing r and omized controlled trial of 51 children aged 2 years 0 months to 4 years 11 months . Participants were assigned to either a target treatment or community treatment group . Families in the target treatment group were given 2 hours of therapy and coaching each week in an intervention emphasizing social-interaction and the parent-child relationship . Children in the community treatment group received a variety of services averaging 3.9 hours per week . After 12 months , outcomes were measured to determine changes in the groups in social interaction and communication . In addition , a regression analysis was conducted to determine whether changes in social interaction skills were associated with language development . Results suggest that children in the treatment group made significantly greater gains in social interaction skills in comparison to the community treatment group , but no between-group differences were found for st and ard language assessment s. Initiation of joint attention , involvement , and severity of language delay were found to be significantly associated with improvement of language skills in children with autism . Finally caregiver skills targeted by the intervention were found to be significantly associated with changes in children ’s interaction skills",
"BACKGROUND Deficits in joint attention ( JA ) and joint engagement ( JE ) represent a core problem in young children with autism as these affect language and social development . Studies of parent-mediated and specialist-mediated JA-intervention suggest that such intervention may be effective . However , there is little knowledge about the success of the intervention when done in preschools . AIM Assess the effects of a preschool-based JA-intervention . METHODS 61 children ( 48 males ) with autistic disorder ( 29 - 60 months ) were r and omized to either 8 weeks of JA-intervention , in addition to their preschool programs ( n = 34 ) , or to preschool programs only ( n = 27 ) . The intervention was done by preschool teachers with weekly supervision by trained counselors from Child and Adolescent Mental Health Clinics ( CAMHC ) . Changes in JA and JE were measured by blinded independent testers using Early Social Communication Scale ( ESCS ) and video taped preschool teacher-child and mother-child play at baseline and post-intervention . CLINICAL TRIALS REGISTRATION Clinical trials.gov : NCT00378157 . RESULTS Intention-to-treat analysis showed significant difference between the intervention and the control group , with the intervention group yielding more JA initiation during interaction with the preschool teachers . The effect generalized to significantly longer duration of JE with the mothers . CONCLUSIONS This is the first r and omized study to show positive and generalized effects of preschool-based JA-intervention",
"BACKGROUND Recent evidence suggests that restricted and repetitive behaviors may differentiate children who develop autism spectrum disorder ( ASD ) by late infancy . How these core symptoms manifest early in life , particularly among infants at high risk for the disorder , is not well characterized . METHODS Prospect i ve , longitudinal parent-report data ( Repetitive Behavior Scales-Revised ) were collected for 190 high-risk toddlers and 60 low-risk controls from 12 to 24 months of age . Forty-one high-risk children were classified with ASD at age 2 . Profiles of repetitive behavior were compared between groups using generalized estimating equations . RESULTS Longitudinal profiles for children diagnosed with ASD differed significantly from high- and low-risk children without the disorder on all measures of repetitive behavior . High-risk toddlers without ASD were intermediate to low risk and ASD positive counterparts . Toddlers with ASD showed significantly higher rates of repetitive behavior across subtypes at the 12-month time point . Repetitive behaviors were significantly correlated with adaptive behavior and socialization scores among children with ASD at 24 months of age , but were largely unrelated to measures of general cognitive ability . CONCLUSIONS These findings suggest that as early as 12 months of age , a broad range of repetitive behaviors are highly elevated in children who go on to develop ASD . While some degree of repetitive behavior is elemental to typical early development , the extent of these behaviors among children who develop ASD appears highly atypical",
"The study evaluated the efficacy a parent training intervention for children with autism based on the TEACCH model . Twenty families were r and omly assigned to the treatment or waitlist group . All families were compared at pre- and post-treatment on formal dependent measures . Direct measures of behavior were compared across six matched pairs using a multiple baseline probe design . The results of the multiple baseline design showed robust support for improvement in child and parent behavior . Due to the sample size and short time frame , results of a repeated measures analysis of variance did not reach significance",
"Earlier intervention improves outcomes for children with autism spectrum disorders ( ASDs ) , but existing identification tools are at the limits of st and ardization with 18-month-olds . We assessed potential behavioural markers of ASD at 18 months in a high-risk cohort of infant siblings of children with ASD . Prospect i ve data were collected using the Autism Diagnostic Observation Schedule ( ADOS ) and Autism Observation Scale for Infants ( AOSI ) on 155 infant siblings and 73 low-risk controls at 18 months . Infants were classified into three groups ( ASD sibs , non-ASD sibs , controls ) based on blind best-estimate diagnosis at age 3 . Fisher 's exact tests , followed by discriminant function analyses , revealed that the majority of informative ADOS items came from the social and behavioural domains , and AOSI items measuring behavioural reactivity and motor control contributed additional information . Findings highlight the importance of considering not only social-communication deficits , but also basic dimensions of temperament including state regulation and motor control when assessing toddlers with suspected ASD",
"The aim of this study was to pilot test a classroom-based intervention focused on facilitating play and joint attention for young children with autism in self-contained special education classrooms . Thirty-three children with autism between the ages of 3 and 6 years participated in the study with their classroom teachers ( n = 14 ) . The 14 preschool special education teachers were r and omly assigned to one of three groups : ( 1 ) symbolic play then joint attention intervention , ( 2 ) joint attention then symbolic intervention , and ( 3 ) wait-list control period then further r and omized to either group 1 or group 2 . In the intervention , teachers participated in eight weekly individualized 1-h sessions with a research er that emphasized embedding strategies targeting symbolic play and joint attention into their everyday classroom routines and activities . The main child outcome variables of interest were collected through direct classroom observations . Findings indicate that teachers can implement an intervention to significantly improve joint engagement of young children with autism in their classrooms . Furthermore , multilevel analyses showed significant increases in joint attention and symbolic play skills . Thus , these pilot data emphasize the need for further research and implementation of classroom-based interventions targeting play and joint attention skills for young children with autism",
"In a r and omized controlled trial , we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism ( VIPP-AUTI ) with 78 primary caregivers and their child ( 16–61 months ) with Autism Spectrum Disorder . VIPP-AUTI is a brief attachment-based intervention program , focusing on improving parent – child interaction and reducing the child ’s individual Autism Spectrum Disorder – related symptomatology in five home visits . VIPP-AUTI , as compared with usual care , demonstrated efficacy in reducing parental intrusiveness . Moreover , parents who received VIPP-AUTI showed increased feelings of self-efficacy in child rearing . No significant group differences were found on other aspects of parent – child interaction or on child play behavior . At 3-months follow-up , intervention effects were found on child-initiated joint attention skills , not mediated by intervention effects on parenting . Implementation of VIPP-AUTI in clinical practice is facilitated by the use of a detailed manual and a relatively brief training of interveners",
"Abstract . Few attempts have been made to conduct r and omised control trials ( RCTs ) of interventions for pre-school children with autism . We report findings of a pilot RCT for a parent training intervention with a focus on the development of joint attention skills and joint action routines . Twenty-four children meeting ICD-10 criteria for childhood autism ( mean age = 23 months ) were identified using the CHAT screen and r and omised to the parent training group or to local services only . A follow-up was conducted 12 months later ( mean age = 35 months ) . There was some evidence that the parent training group made more progress in language development than the local services group . However , the present pilot study was compromised by several factors : a reliance on parental report to measure language , non-matching of the groups on initial IQ , and a lack of systematic checking regarding the implementation of the parent training intervention . Furthermore , three parents in the local services group commenced intensive , home-based behavioural intervention during the course of the study . The difficulties encountered in the conduct of RCTs for pre-school children with autism are discussed . Method ological challenges and strategies for future well- design ed RCTs for autism interventions are highlighted",
"OBJECTIVE This study compared effects of two parent-mediated interventions on joint engagement outcomes as augmentations of an early intervention program for toddlers with autism spectrum disorder ( ASD ) . METHOD Participants included 86 toddlers ( range 22 - 36 months ) with ASD and their primary caregiver . Caregiver-child dyads were r and omized to receive 10 weeks of h and s-on parent training in a naturalistic , developmental behavioral intervention ( joint attention , symbolic play , engagement and regulation-JASPER ) or a parent-only psychoeducational intervention ( PEI ) . Dose was controlled in terms of research er-parent contact and early intervention services received by the child . RESULTS Results yielded significant effects of the JASPER intervention on the primary outcome of joint engagement . The treatment effect was large ( Cohen 's f² = .69 ) and maintained over the 6-month follow-up . JASPER effects were also found on secondary outcomes of play diversity , highest play level achieved , and generalization to the child 's classroom for child-initiated joint engagement . The PEI intervention was found to be effective in reducing parenting stress associated with child characteristics . All secondary effects were generally small to moderate . CONCLUSIONS These data highlight the benefit of a brief , targeted , parent-mediated intervention on child outcomes . Future studies may consider the combination of JASPER and PEI treatments for optimal parent and child outcomes . Trial registry no. NCT00999778"
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Purpose Although self-management education is a key factor in the care for diabetes patients , its implementation in developing countries is not well documented . This systematic review considers the published literature on diabetes self-management education in high and low mortality developing countries . The aim is to provide a state of the art of current practice s and assess program outcomes , cultural sensitivity , and accessibility to low literate patients . Methods The Cochrane Library , PubMed , MEDLINE , PsycInfo , and PsycArticles data bases were search ed for peer- review ed articles on type 2 diabetes published in English between 2009 and 2013 . The World Bank and WHO burden of disease criteria were applied to distinguish between developing countries with high and low mortality . Information was extracted using a vali date d checklist . Results Three review s and 23 primary studies were identified , 18 of which were from low mortality developing countries . Studies from high mortality countries were mostly quasi-experimental , those from low mortality countries experimental . Interventions were generally effective on behavior change and patients ’ glycemic control in the short term ( ≤9 months ) . While 57 % of the studies mentioned cultural tailoring of interventions , only 17 % reported on training of providers , and 39 % were design ed to be accessible for people with low literacy . Conclusions The limited studies available suggest that diabetes self-management education programs in developing countries are effective in the short term but must be tailored to conform to the cultural aspects of the target population | [
"Patient empowerment through self-management education is central to improving the quality of diabetes care and preventing Type 2 Diabetes . Although national programs exist , there is no EU-wide strategy for diabetes self-management education , and patients with limited literacy face barriers to effective self-management . The Diabetes Literacy project , initiated with the support of the European Commission , aims to fill this gap . The project investigates the effectiveness of diabetes self-management education , targeting people with or at risk of Type 2 Diabetes in the 28 EU Member States , as part of a comprehensive EU-wide diabetes strategy . National diabetes strategies in the EU , US , Taiwan , and Israel are compared , and diabetes self-management programs inventorized . The costs of the diabetes care pathway are assessed on a per person basis at national level . A comparison is made of the (cost)-effectiveness of different methods for diabetes self-management support , and the moderating role of health literacy , organization of the health services , and implementation fidelity of education programs are considered . Web-based material s are developed and evaluated by r and omized trials to evaluate if interactive internet delivery can enhance self-management support for people with lower levels of health literacy . The 3-year project started in December 2012 . Several literature review s have been produced and protocol development and research design are in the final stages . Primary and secondary data collection and analysis take place in 2014 . The results will inform policy decisions on improving the prevention , treatment , and care for persons with diabetes across literacy levels",
"BACKGROUND The purpose of this study was to determine the effects of educational program based on the BASNEF ( Belief , Attitude , Subjective Norm , and Enabling Factors ) Model on eye care among patients with insulin independent diabetes mellitus in Shiraz City , Fars Province , Iran . METHODS We enrolled 100 patients with non-insulin independent diabetes mellitus ( Type II ) fulfilling the inclusion criteria of this experimental study . The participants were r and omly divided into two groups , one experimental , and one control group . All groups completed the question naires based on the BASNEF Model , a checklist related to patient 's practice including patients ' HbA1c and FBS levels , the pre-test results of an ophthalmologist 's eyes examination and the results of three months follow-up . The experimental group participated in eight educational sessions during the interventional . The data analysis used including chi square-test , t-test , and ANOVA . RESULTS The knowledge and all BASNEF Model components were significantly increased in the experimental group compared to the control group after intervention . In addition , behavioral eye care , such as physical activities , regular taking medicine , having eye examination , FBS checking , having appropriate diet , HbA1c level , and fasting blood sugar levels improved significantly among the experimental group compared to the control group . CONCLUSION Applying the BASNEF Model is very effective for developing an educational program for diabetic patients , in order to control their blood sugar and enhancing behavioral eye care . Besides such programs , follow up education on controlling and monitoring is highly recommended",
"PURPOSE Few culturally competent health programs have been design ed for Mexican Americans , a group that bears a disproportionate burden of Type 2 diabetes . In Starr County , a Texas-Mexico border community , investigators design ed and tested a culturally competent intervention aim ed at improving the health of this target population . The purpose of this article is to describe the development process of this diabetes education and support group intervention . METHODS The development stages were ( 1 ) community assessment , ( 2 ) intervention design , ( 3 ) selection or development of outcomes , ( 4 ) pilot testing , and ( 5 ) a r and omized clinical investigation . RESULTS Focus group participants identified knowledge deficits regarding diabetes and self-management strategies , and suggested characteristics of an effective intervention for Mexican Americans . Outcome measures included metabolic control indicators , a newly developed knowledge instrument , and an existing health belief instrument . Preliminary analyses indicated that the intervention was successful in significantly improving metabolic control in the target population . CONCLUSIONS Developing successful diabetes interventions for minority groups requires a number of stages , careful planning , assessment of cultural characteristics of the target population , and a systematic approach to implementation",
"AIMS AND OBJECTIVES To examine the effect of a hospital-based clinic intervention on glycaemic control self-efficacy and glycaemic control behaviour of Chinese patients with type 2 diabetes mellitus ( DM ) . BACKGROUND Self-efficacy expectations are related to self-management of diabetes and , in conjunction with environmental support , are better predictors of behaviour than are knowledge and skills . Enhancing self-efficacy in patients with DM has been shown to have a positive effect on behavioural change and positively influence long-term glycaemic control . DESIGN A r and omised controlled trial study consisting of two-group pretest-post-test . METHODS One hundred and fifty-seven patients with type 2 DM were r and omly divided into two groups : ( 1 ) the experimental group ( 77 patients ) receiving one-month hospital-based clinic intervention and ( 2 ) the control group ( 80 patients ) receiving usual care . Data collection instruments used in this study were Diabetes Management Self-Efficacy Scale and Summary of Diabetes Self-Care Activities Measure . Outcomes were determined by changes in glycaemic control self-efficacy and glycaemic control behaviour of patients with type 2 DM . RESULTS The findings revealed that the experimental group showed statistically significant improvement in glycaemic control self-efficacy and glycaemic control behaviour immediately and four months after the intervention ( F = 26.888 , df = 1 , 155 , p One-month hospital-based clinic intervention could be useful in improving glycaemic control self-efficacy and glycaemic control behaviour . RELEVANCE TO CLINICAL PRACTICE Nurses can learn and use the sources of self-efficacy to enhance patients ' self-efficacy on their glycaemic control in clinical care . The health education is most important in nursing care and should be considered while organising the hospital-based clinic intervention",
"BACKGROUND : Patients have a major role in the control and treatment of type 2 diabetes . So , knowledge of different aspects of this disease especially diet therapy is very important for these patients . This study was conducted to determine the effectiveness of the Health Belief Model ( HBM ) on nutrition education in type 2 diabetic patients . METHOD : Eighty eight type 2 diabetic patients attending Iranian Diabetes Association seminars were r and omly selected to participate in the study ( 44 in intervention group and 44 in control group ) . The intervention was consisted of two educational sessions each one for 80 minutes . Data were collected by a vali date d and reliable question naire ( 58 questions ) before intervention and one month after intervention . RESULTS : After intervention , knowledge scores increased in the intervention group compared to the control group ( Mean differences in the intervention and test group : 22.68 ± 15.90 vs - 2.27 ± 17.30 , P ) . Perceived susceptibility increased significantly in the intervention group compared to the control group ( 27.5 ± 18.5 vs 3.9 ± 17.2 , P for perceived severity , perceived threatened and perceived benefits ( P contrast perceived barriers reduced in the intervention group compared to the control diet ( -14.7 ± 13.3 vs 0.9 ± 13.9 , P , behavior grade s increased more than control group ( 34.61 ± 14.93 vs -0.23 ± 8.52 , P model in nutritional education to the diabetic patients was confirmed in the present study",
"BACKGROUND : This study was conducted to evaluate the effect of a clinical pharmacist-led patient education program for type 2 diabetic patients at Isfahan Endocrine & Metabolism Research Center ( IEMRC ) from April 2008 to January 2009 . METHODS : In a r and omized controlled clinical trial , a total of 172 patients with uncontrolled type 2 diabetes were selected and r and omly allocated into control and intervention groups . After taking informed written consent , the intervention group received an educational program about oral anti-hyperglycemic medications , adherence , diabetes dairy log and pill box usage . Patient 's glycemic control in the intervention group was followed for three months through either telephone or face to face interviews with the pharmacist . Fasting blood glucose and HbA1c were measured at the start and end of the pharmacistled drug education program for both intervention and control groups . RESULTS : After a three months follow-up , mean fasting blood glucose and HbA1c of the patients in the intervention group decreased significantly compared to control group ( p diabetes management of type 2 diabetics by involving a pharmacist in the multidisciplinary teams in the outpatient clinics . The results suggest the benefits of adding adherence education to the diabetic education programs",
"AIMS To explore the impact of pictorial image and teach back educational strategies on knowledge , adherence to medication and diet among patients with type 2 diabetes and low health literacy in Saqqez , Iran . METHODS In this r and omized controlled trial , 127 patients with type 2 diabetes who had low health literacy were r and omly allocated into three arms of the study ( pictorial image , teach back , and control groups ) . The two intervention groups received education within three weekly sessions , each lasting 20 min . The level of functional health literacy in adults ( TOFHLA ) , diabetes knowledge , and adherence to medication and diet were measured and compared in the three groups before and six weeks after the interventions . We used intention to treat analysis . Data were analyzed using ANOVA and Paired t test . RESULTS Mean scores of knowledge , adherence to medication and diet revealed significant differences between two intervention groups and control group ( P knowledge , as well as adherence to medications and diet among patients with type 2 diabetes and low health literacy . Both educational strategies seem to be effective for patients with low health literacy and are recommended to be used according to patients ' conditions",
"The prevalence of diabetes in India has grown over the past decade . Diabetic patients develop complications due to poor awareness regarding the disease and inadequate glycemic control . Patient education is the most effective way to lessen the complications of diabetes and its management . A total of 207 ( 85 males and 122 females ) type 2 diabetes mellitus patients were enrolled and r and omized into test and control groups . Patients in the test group received counseling at each visit and information leaflets from the pharmacist ; the control group patients received counseling and information leaflets only at the end of the study . A vali date d knowledge , attitude , and practice ( KAP ) question naire was administered to both test and control group patients at baseline and at final follow-up to assess awareness regarding disease management . Glucose and lipid levels were also evaluated at baseline and final follow-up in both the groups . At the end of the study , the KAP score of test group patients improved significantly ( P postpr and ial blood glucose ( PPBG ) levels decreased significantly in the test group . Total cholesterol ( TC ) , triglycerides ( TGL ) , and low density lipoprotein levels ( LDL ) also showed a decrease in the test group . Thus , our study reveals that pharmacist counseling might be an important element in diabetes management programs",
"Background Research ers believe that most of diabetic patients are not necessarily aware of the role of exercises , especially jogging in controlling their disease . The purpose of this study was to evaluate the effect of educational program and jogging based on health belief model ( HBM ) on sugar control in type 2 diabetic patients . Methods One hundred diabetic ( type 2 ) patients were involved in this prospect i ve quasi-experimental interventional study . Patients were r and omly divided into two groups of experimental and control . Data was collected using a question naire based on the HBM model , a check list for patient`s practice s and a check list for recording the patient`s hemoglobin ( HbA1C ) and fasting blood sugar ( FBS ) levels . Results Our findings indicated that after intervention , there was a significant difference between the mean score of the HBM model variables ( susceptibility , severity , benefit and perceived obstacles , ) in the experimental group compared to the control group . Additionally , behavioral jogging , level of HbA1C and FBS levels improved significantly among the experimental group when compared to the control group . Conclusion Applying the HBM model was found to be a very effective means for developing an educational program of jogging for diabetics , in order to control their blood sugar",
"Background Diabetes has become a major public health problem in China . Support of patient self-management is a key component of effective diabetes care and improved patient outcomes . A series of peer-led community-based disease-specific self-management programs including diabetes have been widely disseminated in urban communities of Shanghai since 1999 . However , the strategy of using trained lay leaders to support patient self-management faces challenges in rural communities in Shanghai . This study developed a Chinese diabetes group visit program as an alternative approach to support patient self-management and examined its effectiveness on self-management behaviors , self-efficacy and health status for patients with type 2 diabetes in rural communities of Shanghai . Methods 208 patients with type 2 diabetes aged 35–80 years were r and omly assigned to the intervention group ( n=119 ) of 12 monthly group visit sessions or to a control group ( n=89 ) of usual care . The trial was undertaken in two rural communities in Shanghai , China . R and omization and allocation to study group were carried out by using a r and om number table . Analysis of covariance was used to compare changes in the 17 self-management behavior , self-efficacy and health status related variables in two groups at 12 months ’ follow-up based on 176 patients ( n=98 ; n=78 ) . Results Compared with controls , the intervention patients , on average , increased their duration of aerobic exercise by more than 40 minutes per week ( p=0.001 ) ; had significant increase of 0.71 in mean score on self-efficacy to manage diabetes ( p=0.02 ) ; and had significant improvements in measures of illness intrusiveness and systolic blood pressure . The intervention patients attended an average of 10.1 of the 12 program sessions with 75.6 % of them attended 10 and more sessions . Conclusion The Chinese diabetes group visit model is a feasible , acceptable and effective alternative for supporting diabetes patient self-management in Chinese rural communities . The model requires larger studies to determine its effect on blood glucose control and health care utilization . Trial registration IS RCT",
"OBJECTIVE To evaluate the effect of a culturally sensitive diabetes self-management education program that uses a low-cost , peer-educator format ( Project Dulce ) on glucose control and metabolic parameters in low-income Mexican Americans with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 207 Mexican-American patients recruited from federally funded community health centers in San Diego County with HbA1c > 8 % were r and omly assigned to the Project Dulce peer intervention or continuation of st and ard diabetes care . The primary outcome of interest was HbA1c . RESULTS The majority of subjects were born in Mexico , were female , were middle-aged , had less than an eighth- grade education , and had high baseline HbA1c levels . Significant time-by-group interaction effects for HbA1c ( P = 0.02 ) and diastolic blood pressure ( P = 0.04 ) indicated that the Project Dulce group exhibited greater improvement ( i.e. , decreases ) across time . Within-group analyses showed that the intervention group exhibited significant improvements from baseline to month 4 in absolute levels of HbA1c ( −1.7 % , P = 0.001 ) and HDL cholesterol ( + 1.4 mg/dL , P = 0.01 ) and from baseline to month 10 in absolute levels of HbA1c ( −1.5 % , P = 0.01 ) , total cholesterol ( −7.2 mg/dL , P = 0.04 ) , HDL cholesterol ( + 1.6 mg/dL , P = 0.01 ) , and LDL cholesterol ( −8.1 mg/dL , P = 0.02 ) . No significant changes were noted in the control group . CONCLUSIONS This r and omized trial , using the Project Dulce model of culturally sensitive , peer-led education , demonstrates improvement in glucose and metabolic control and suggests that this low-cost approach to self-management education for high-risk diabetic population s is effective",
"Background Type II diabetes and its complications impose a large economic burden on health care systems . This study aims to assess the effectiveness of educational intervention based on extended health belief model on type 2 diabetic patients . Methods 120 patients with type II diabetes referring to r and omly selected hospitals of Tehran University of Medical Sciences were enrolled in this educational intervention study . Patients were r and omly divided into two groups ( intervention and control ) . Data were collected using a question naire including demographic information and extended health belief model constructs . Two face to face educational sessions were conducted for each patient . Data were collected in two groups at three stages of the study ; before the educational sessions and at 3 months and 6 months intervals . Analysis was performed by SPSS ( 17.0 ) and STATA ( 11.0 ) using independent T-test , Chi-square , Fisher ’s exact test , analysis of covariance and Generalized Estimating Equation . A p value of less than 0.05 was regarded as statistically significant . Results The educational program had a positive and significant impact ( p extended health model belief constructs ( including perceived susceptibility , perceived intensity , perceived benefits , perceived barriers and self-efficacy ) in experimental group , 3 and 6 months after the intervention . Conclusions The results of this study showed the importance of extended health belief model based education in improving the model constructs and increasing self-efficacy in patients with type-2 diabetes",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"OBJECTIVE Patients with low health literacy have difficulty underst and ing prescription drug labels and other medication instructions . This article describes the development , implementation , and preliminary evaluation of an illustrated medication schedule ( a \" pill card \" ) that depicts a patient 's daily medication regimen using pill images and icons . METHODS Participants in a r and omized controlled trial who were assigned to receive the pill card intervention described their use of the card and its perceived effectiveness . Responses were analyzed by level of patient literacy and other characteristics . RESULTS Among the 209 respondents , 173 ( 83 % ) reported using the pill card when they initially received it , though use declined to 60 % approximately 3 months later . Patients with inadequate or marginal literacy skills , less than high school education , or cognitive impairment were most likely to refer to the card on a regular basis initially and at 3 months ( p pill card users ( 92 % ) rated the tool as very easy to underst and , and 94 % found it helpful for remembering important medication information , such as the name , purpose , or time of administration . CONCLUSION Nearly all patients considered an illustrated medication schedule to be a useful and easily understood tool to assist with medication management . Patients with limited literacy skills , educational attainment , or cognitive function referred to the aid with greater frequency . PRACTICE IMPLICATION S Picture-based instructions promote better underst and ing of prescription medications , particularly among patients with limited literacy skills or cognitive impairment , and should be used more widely in practice",
"Background : Training and continuous dynamic communication between patients and health professionals in chronic diseases like diabetes , is important . The aim of this study is to evaluate the effects of diabetes self-care group education and nurse- telephone follow-up on glycemic control and compliance with treatment orders in patients with type 2 diabetes attending to diabetes clinic in khomein . Methods : In this clinical trial , 62 patients with type 2 diabetes who attending to the diabetes clinic selected and were r and omly assigned to experiment and control groups . Self-care group education was applied for case group ( n = 31 ) and they were followed up using telephone calls for 12 weeks by a nurse . The control group ( n = 31 ) received the conventional management . Demographic characteristics , compliance with treatment recommendations ( diet , drug use , exercise ) and blood glucose control indices were recorded before and after interventions . Data were analyzed by SPSS software version 16 using independent t-test , paired t-test , Chi-square test , non-parametric tests , mixed model ( ANOVA + repeated measure ) and ANCOVA . Results : The mean age of intervention and control groups was 50.9 ± 7.3 and 55.1 ± 10.1 years , respectively . Blood glucose indices ( FBS , 2 hpp BS , Hb A1C ) were improved in both case and control group after intervention but it was only statistically significant in case group P > 0.0001 . During study , percentage of patients with very good compliance in control group decrease from 12.5 % to zero ( 0 % ) , whereas in experiment group these amounts increase from 6.5 % to 90.3 % P > 0.0001 . Conclusions : According to the results of the current study self-care group education and 12 weeks follow-up by a nurse using telephone causes significant improvement in metabolic parameters and adherence to treatment recommendations in diabetic patients",
"AIM To evaluate the impact of diabetes education provided to patients with type 2 diabetes mellitus ( T2DM ) in non-controlled studies ( \" real-world conditions \" ) on quality of care , re source consumption and conditions of employment . METHODS This cross-sectional study and longitudinal follow-up describe the data ( demographic and socioeconomic profiles , clinical characteristics , treatment of hyperglycaemia and associated cardiovascular risk factors , re source consumption ) collected during the second phase ( 2006 ) of the International Diabetes Management Practice s Study ( IDMPS ) . Patients received diabetes education directly from the practice nurse , dietitian or educator , or were referred to ad hoc group-education programmes ; all programmes emphasized healthy lifestyle changes , self-care and active participation in disease control and treatment . Educated vs non-educated T2DM patients ( n=5692 in each group ) , paired by age , gender and diabetes duration , were r and omly recruited for the IDMPS by participating primary -care physicians from 27 countries in Eastern Europe , Asia , Latin America and Africa . Outcome measures included clinical ( body weight , height , waist circumference , blood pressure , foot evaluation ) , metabolic ( HbA(1c ) levels , blood lipid profile ) and biochemical control measures . Treatment goals were defined according to American Diabetes Association guidelines . RESULTS T2DM patients ' education significantly improved the percentage of patients achieving target values set by international guidelines . Educated patients increased their insulin use and self-care performance , had a lower rate of chronic complications and a modest increase in cost of care , and probably higher salaries and slightly better productivity . CONCLUSION Diabetes education is an efficient tool for improving care outcomes without having a major impact on healthcare costs",
"OBJECTIVE To determine the effect of a bicultural community health worker ( CHW ) on completion of diabetes education in an inner-city Hispanic patient population and to evaluate the impact of completion of the education program on patient knowledge , self-care behaviors , and glycemic control . RESEARCH DESIGN AND METHODS Patients were r and omized into CHW intervention and non-CHW intervention groups . All patients received individualized , comprehensive diabetes education from a certified diabetes nurse educator after baseline demographic information , diabetes knowledge , diabetes self-care practice s , and glycohemoglobin levels were assessed . Rates of education program completion were determined . Diabetes knowledge , self-care practice s , and glycohemoglobin levels were reassessed at program completion and at a later postprogram follow-up medical appointment and compared to baseline . Logistic regression analysis and the Mantel-Haenszel χ2 statistic were used to determine the effect of the CHW assignment on program completion . Analyses of covariance were performed with end-of-treatment behavior scores , knowledge scores , and glycohemoglobin levels as outcome variables , controlling for baseline values and testing for the effect of CHW assignment . RESULTS Of 64 patients enrolled in the study , 40 ( 63 % ) completed and 24 ( 37 % ) dropped out before completing the diabetes education program . Of the patients having CHW intervention , 80 % completed the education program , compared with 47 % of patients without CHW intervention ( P = 0.01 ) . “ Dropouts ” were younger ( age 47.5 ± 12.5 years [ mean ± SD ] ) compared with patients who completed the program ( 55.9 ± 9.9 years ) ( P = 0.004 ) . Dropout status showed no significant relationship to educational level achieved or literacy level . For the program “ completers , ” knowledge levels and selected self-care practice s significantly improved , and glycohemoglobin levels improved from a baseline level of 11.7 % to 9.9 % at program completion ( P = 0.004 ) and 9.5 % at the postprogram follow-up ( P program completion , controlling for financial status and language spoken , was extremely robust ( P = 0.007 ) . The effect of the CHW on knowledge , self-care behavior , or glycohemoglobin outcome variables was not statistically significant . CONCLUSIONS These findings suggest that intervention with a bicultural CHW improved rates of completion of a diabetes education program in an inner-city Hispanic patient population irrespective of literacy or educational levels attained . Our data further suggests that completion of individualized diabetes educational strategies leads to improved patient knowledge , self-care behaviors , and glycemic control"
] | 41163a08-06ff-11f0-808a-c43d1ab1c353 |
Aims The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation ( PPI ) after transcatheter aortic valve implantation ( TAVI ) with new-generation prostheses remains debated . This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical , anatomical , and procedural factors associated with PPI . In addition , the incidence of PPI after TAVI with early generation prostheses was review ed for comparison . Methods and results According to the Preferred Reporting Items for Systematic Review s and Meta-Analyses checklist , this systematic review screened original articles published between October 2010 and October 2017 , reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses . Of the 1406 original articles identified in the first search for new-generation TAVI devices , 348 articles were examined for full text , and finally , 40 studies ( n = 17 139 ) were included . The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3 % and 36.1 % . For balloon-exp and able prostheses , the PPI rate remained low when using an early generation SAPIEN device ( ranging between 2.3 % and 28.2 % ) , and with the new-generation SAPIEN 3 device , the PPI rate was between 4.0 % and 24.0 % . For self-exp and able prostheses , the PPI rates were higher with the early generation CoreValve device ( 16.3 - 37.7 % ) , and despite a reduction in PPI rates with the new Evolut R , the rates remained relatively higher ( 14.7 - 26.7 % ) . When dividing the studies according to the highest ( > 26.0 % ) and the lowest ( PPI rate , patients within the highest quintile were more frequently women when compared with the lowest quintile group ( 50.9 % vs. 46.3 % , P Pre-existent conduction abnormalities ( electrical factor ) , calcification of the left ventricular outflow tract ( anatomical factor ) , and balloon valvuloplasty and depth of implantation ( procedural factors ) were associated with increased risk of PPI . Conclusion The rate of PPI after TAVI with new-generation devices is highly variable . Specific recommendations for implantation of each prosthesis , taking into consideration the presence of pre-existent conduction abnormalities and anatomical factors , may be needed to reduce the risk of PPI | [
"IMPORTANCE Transcatheter aortic valve replacement ( TAVR ) is an effective treatment option for high-risk patients with severe aortic stenosis . Different from surgery , transcatheter deployment of valves requires either a balloon-exp and able or self-exp and able system . A r and omized comparison of these 2 systems has not been performed . OBJECTIVE To determine whether the balloon-exp and able device is associated with a better success rate than the self-exp and able device . DESIGN , SETTING , AND PATIENTS The CHOICE study was an investigator-initiated trial in high-risk patients with severe aortic stenosis and an anatomy suitable for the transfemoral TAVR procedure . One hundred twenty-one patients were r and omly assigned to receive a balloon-exp and able valve ( Edwards Sapien XT ) and 120 were assigned to receive a self-exp and able valve ( Medtronic CoreValve ) . Patients were enrolled between March 2012 and December 2013 at 5 centers in Germany . INTERVENTIONS Transfemoral TAVR with a balloon-exp and able or self-exp and able device . MAIN OUTCOMES AND MEASURES The primary end point was device success , which is a composite end point including successful vascular access and deployment of the device and retrieval of the delivery system , correct position of the device , intended performance of the heart valve without moderate or severe regurgitation , and only 1 valve implanted in the proper anatomical location . Secondary end points included cardiovascular mortality , bleeding and vascular complications , postprocedural pacemaker placement , and a combined safety end point at 30 days , including all-cause mortality , major stroke , and other serious complications . RESULTS Device success occurred in 116 of 121 patients ( 95.9 % ) in the balloon-exp and able valve group and 93 of 120 patients ( 77.5 % ) in the self-exp and able valve group ( relative risk [ RR ] , 1.24 , 95 % CI , 1.12 - 1.37 , P residual more-than-mild aortic regurgitation ( 4.1 % vs 18.3 % ; RR , 0.23 ; 95 % CI , 0.09 - 0.58 ; P need for implanting more than 1 valve ( 0.8 % vs 5.8 % , P = .03 ) in the balloon-exp and able valve group . Cardiovascular mortality at 30 days was 4.1 % in the balloon-exp and able valve group and 4.3 % in the self-exp and able valve group ( RR , 0.97 ; 95 % CI , 0.29 - 3.25 ; P = .99 ) . Bleeding and vascular complications were not significantly different , and the combined safety end point occurred in 18.2 % of those in the balloon-exp and able valve group and 23.1 % of the self-exp and able valve group ( RR , 0.79 ; 95 % CI , 0.48 - 1.30 ; P = .42 ) . Placement of a new permanent pacemaker was less frequent in the balloon-exp and able valve group ( 17.3 % vs 37.6 % , P = .001 ) . CONCLUSIONS AND RELEVANCE Among patients with high-risk aortic stenosis undergoing TAVR , the use of a balloon-exp and able valve result ed in a greater rate of device success than use of a self-exp and able valve . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01645202",
"OBJECTIVES The aim of the CoreValve prospect i ve , international , post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation ( PPI ) after transcatheter aortic valve replacement with the Medtronic CoreValve System ( Minneapolis , Minnesota ) using optimized implantation techniques and application of international guidelines on cardiac pacing . BACKGROUND Conduction disturbances are a frequent complication of transcatheter aortic valve replacement . The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI . METHODS The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth ( ≤6 mm below the aortic annulus ) . The timing and resolution of all new-onset conduction disturbances were analyzed . RESULTS A total of 194 patients were treated . The overall rate of PPI for Class I/II indications was 18.2 % . An optimal depth was reached in 43.2 % of patients , with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm , compared with those with deeper implants ( 13.3 % vs. 21.1 % ; p = 0.14 ) . In a paired analysis , new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4 % and 39.0 % of patients , respectively , and resolved spontaneously within 30 days in 43.2 % and 73.9 % , respectively . In patients with new PPI , the rate of intrinsic sinus rhythm increased from 25.9 % at 7 days to 59.3 % at 30 days ( p = 0.004 ) . CONCLUSIONS Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement , compared with results reported in previous studies . ( CoreValve Advance-II Study : Prospect i ve International Post-Market Study [ ADVANCE II ] ; NCT01624870 )",
"OBJECTIVES This study sought to evaluate this transcatheter aortic valve ( TAV ) bioprosthesis in patients who are poorly suitable for surgical aortic valve ( AV ) replacement . BACKGROUND A novel self-exp and able TAV bioprosthesis was design ed to provide a low-profile delivery system , conformable annular sealing , and the ability to resheath and reposition during deployment . METHODS The Evolut R U.S. study included 241 patients with severe aortic stenosis who were deemed to be at least high risk for surgery treated at 23 clinical sites in the United States . Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria . An independent echocardiography laboratory was used to evaluate hemodynamic outcomes . RESULTS Patients were elderly ( 83.3 ± 7.2 years of age ) and had high surgical risk ( Society of Thoracic Surgeons predicted risk of mortality of 7.4 ± 3.4 % ) . The majority of patients ( 89.5 % ) were treated by iliofemoral access . Resheathing or recapturing was performed in 22.6 % of patients ; more than 1 valve was required in 3 patients ( 1.3 % ) . The 30-day outcomes included all-cause mortality ( 2.5 % ) , disabling stroke ( 3.3 % ) , major vascular complications ( 7.5 % ) , life-threatening or disabling bleeding ( 7.1 % ) , and new permanent pacemaker ( 16.4 % ) . AV hemodynamics were markedly improved at 30 days : the mean AV gradient was reduced from 48.2 ± 13.0 mm Hg to 7.8 ± 3.1 mm Hg ( p Moderate residual paravalvular leak was identified in 5.3 % of patients . CONCLUSIONS We conclude that this novel self-exp and ing TAV bioprosthesis is safe and effective for the treatment of patients with severe aortic stenosis who are suboptimal for surgery . ( Medtronic CoreValve Evolut R U.S. Clinical Study ; NCT02207569 )",
"Aims RESPOND is a prospect i ve , open-label , single-arm study evaluating the outcomes following transcatheter aortic valve implantation ( TAVI ) with the repositionable and fully retrievable Lotus Valve used in routine clinical practice for the treatment of patients with aortic valve stenosis . Methods and results RESPOND enrolled 1014 patients at sites across Europe , New Zeal and , and Latin America ; 996 patients received a Lotus Valve ( mean age : 80.8 years ; 50.8 % female ; Society of Thoracic Surgeons score : 6.0 ± 6.9 ) . Repositioning was attempted in 29.2 % of patients , with 99 % success . The rate of all-cause mortality in the intent-to-treat population at 30 days ( primary endpoint ) was 2.6 % ( P a Lotus Valve , the 30-day overall and disabling stroke rates were 3.0 % and 2.2 % , respectively . The 30-day permanent pacemaker implantation rate was 30.0 % in all patients , and 34.6 % in pacemaker-naïve patients . Echocardiographic data at baseline and pre-discharge were assessed by an independent core laboratory . Mean aortic valve gradient declined from 37.7 ± 15.2 mmHg at baseline to 10.8 ± 4.6 mmHg at hospital discharge ( P 0.001 ) . Aortic valve area increased from 0.7 ± 0.2 cm2 at baseline to 1.8 ± 0.4 cm2 at discharge ( P , paravalvular leak ( PVL ) was absent or trace in 92 % of patients ; no patients had severe PVL , 0.3 % of patients exhibited moderate PVL , and 7.7 % of patients had mild PVL . Clinical follow-up in RESPOND will extend to 5 years . Conclusion The results of RESPOND confirm the safety and efficacy of TAVI with the Lotus Valve in routine clinical practice . Trial registration Clinical Trials.gov # NCT 02031302",
"AIMS Long-term outcomes are available for first-generation transcatheter heart valves but data on second-generation devices are scarce . We aim ed to provide an oversight of all patients implanted with a second-generation valve in our centre . METHODS AND RESULTS From April 2012 to July 2016 , 219 patients were enrolled in this prospect i ve single-centre experience ; they received either the transapical ACURATE TA ( n=99 ) or the transfemoral ACURATE neo ( n=120 ) prosthesis . Data were collected during the hospital stay and telephone follow-ups were conducted at 30 days post procedure and annually thereafter . Patients were 80.9±4.4 years old with a mean logistic EuroSCORE I of 19.3±13.9 % . Transapical patients had significantly more comorbidities at baseline . Post intervention , mean gradient was reduced to 10.6±9.2 mmHg , and 1.9 % had moderate paravalvular regurgitation . Mean follow-up time , based on the last patient contact , was 217±188 days for the transfemoral and 525±413 days for the transapical group . Thirty-day mortality was 2.5 % and 4.0 % , and one-year Kaplan-Meier survival was 94.8 % ( 95 % CI : 87.5 - 97.9 ) and 81.9 % ( 95 % CI : 72.0 - 88.5 ) , respectively . At two years , survival was 64.9 % ( 95 % CI : 52.6 - 74.7 ) for transapical patients . CONCLUSIONS This early single-centre experience showed very good safety and performance outcomes in patients treated with the ACURATE prostheses",
"Abstract OBJECTIVES : The ACURATE TATM system is a self-exp and ing transcatheter heart valve system design ed for transapical access which has been proven to be safe and effective in the controlled setting of clinical trials . The SAVI-1 and SAVI-2 registries aim ed to assess whether these promising outcomes can be translated into all-comers clinical routine . METHODS : From November 2011 to 2012 ( SAVI-1 ) , and November 2013 to 2014 ( SAVI-2 ) , a total of 500 patients were enrolled in the prospect i ve , all-comers , multicentre , multinational SAVI registries . Patients were treated according to the st and ard of care at their respective hospitals . We report and compare 30-day and 1-year clinical outcomes between SAVI-1 and -2 . RESULTS : Patients were 80.8 ± 6.1 years old , the mean logistic EuroSCORE-I was 23.4 ± 14.3 % . Valves were deployed under rapid pacing in 71.3 % of the procedures in SAVI-1 , and in 3.6 % in SAVI-2 . There was no relevant difference in clinical and echocardiographic outcomes between SAVI-1 and SAVI-2 . Overall mortality at 30 days and 1 year was 6.8 % and 19.9 % , the stroke rate was 2.2 % and 3.7 % , respectively ; 10.2 % of patients had received a permanent pacemaker , and no transcatheter valve-related complications after discharge were observed . Paravalvular leakage ≥2 + was reported in 1.9 % of the patients at the early follow-up , and in 2.6 % at the 1-year follow-up . CONCLUSIONS : The SAVI-registries have confirmed that transapical implantation using the ACURATE TATM device is safe and effective in an all-comers setting with low complication rates and stable performance outcomes at short-term and 1 year ; outcomes were similar between SAVI-1 and -2 . Clinical Trials.gov :",
"OBJECTIVES To evaluate balloon-exp and able and self-exp and ing third-generation transcatheter aortic valve replacement ( TAVR ) devices according to patient selection criteria and outcomes . BACKGROUND Two competing third-generation TAVR technologies are currently commercially available in the US . There are no published head-to-head comparisons of the relative performance of these two devices . METHODS 257 consecutive patients undergoing TAVR with a third-generation balloon-exp and able ( Edwards Sapien 3 ) or self-exp and ing device ( Medtronic CoreValve Evolut R ) at a single US medical center were included . Choice of TAVR device was at the discretion of the multidisciplinary Heart Team . Baseline clinical characteristics , echocardiographic and CT imaging , procedural and 30-day outcomes were prospect ively collected . RESULTS 74 patients received a self-exp and ing valve ( SEV ) and 183 received a balloon-exp and able valve ( BEV ) . Patients selected for SEV were more frequently women , with lower body surface area and smaller calcified iliofemoral arteries . Three SEV patients required implantation of a second valve to successfully treat paravalvular leak . Only one BEV patient had moderate paravalvular regurgitation . There was no difference in the rate of stroke , major vascular complication or bleeding . Permanent pacemaker implantation rate was significantly higher with SEV ( 12.7 % vs 4.7 % , P = 0.49 ) and hospital length of stay was longer ( 8.3 % vs 6.5 % , P = 0.043 ) , but 30-day mortality was comparable ( 1.4 % vs 1.6 % , P = 1.00 ) . CONCLUSIONS Short-term outcomes were equivalent between the two technologies . Clinical ly significant paravalvular regurgitation was rare . SEV were more frequently selected in women and patients with challenging transfemoral access , but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay",
"AIMS Based on r and omized trials using first-generation devices , transcatheter aortic valve replacement ( TAVR ) is well established in the treatment of high-risk ( HR ) patients with severe aortic stenosis ( AS ) . To date , there is a paucity of adjudicated , prospect i ve data evaluating outcomes with newer generation devices and in lower risk patients . We report early outcomes of a large , multicentre registry of inoperable , HR , and intermediate-risk ( IR ) patients undergoing treatment with the next-generation SAPIEN 3 transcatheter heart valve ( THV ) . METHODS AND RESULTS Patients with severe , symptomatic AS ( 583 high surgical risk or inoperable and 1078 IR ) were enrolled in a multicentre , non-r and omized registry at 57 sites in the USA and Canada . All patients received TAVR with the SAPIEN 3 system via transfemoral ( n = 1443 , 86.9 % ) and transapical or transaortic ( n = 218 , 13.1 % ) access routes . The rate of 30-day all-cause mortality was 2.2 % in HR/inoperable patients [ mean Society of Thoracic Surgeons ( STS ) score 8.7 % ] and 1.1 % in IR patients ( mean STS score 5.3 % ) ; cardiovascular mortality was 1.4 and 0.9 % , respectively . In HR/inoperable patients , the 30-day rate of major/disabling stroke was 0.9 % , major bleeding 14.0 % , major vascular complications 5.1 % , and requirement for permanent pacemaker 13.3 % . In IR patients , the 30-day rate of major/disabling stroke was 1.0 % , major bleeding 10.6 % , major vascular complications 6.1 % , and requirement for permanent pacemaker 10.1 % . Mean overall Kansas City Cardiomyopathy Question naire score increased from 47.8 to 67.8 ( HR/inoperable , P Overall , paravalvular regurgitation at 30 days was none/trace in 55.9 % of patients , mild in 40.7 % , moderate in 3.4 % , and severe in 0.0 % . Mean gradients among patients with paired baseline and 30-day or discharge echocardiograms decreased from 45.8 mmHg at baseline to 11.4 mmHg at 30 days , while aortic valve area increased from 0.69 to 1.67 cm(2 ) . CONCLUSIONS The SAPIEN 3 THV system was associated with low rates of 30-day mortality and major/disabling stroke as well as low rates of moderate or severe paravalvular regurgitation . TRIAL REGISTRATION Clinical Trials.gov # NCT01314313",
"BACKGROUND Clinical outcomes in large patient population s from real-world clinical practice with a next-generation self-exp and ing transcatheter aortic valve are lacking . OBJECTIVES This study sought to document the clinical and device performance outcomes of transcatheter aortic valve replacement ( TAVR ) with a next-generation , self-exp and ing transcatheter heart valve ( THV ) system in patients with severe symptomatic aortic stenosis ( AS ) in routine clinical practice . METHODS The FORWARD ( CoreValve Evolut R FORWARD ) study is a prospect i ve , single-arm , multinational , multicenter , observational study . An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions . An independent echocardiographic core laboratory evaluated all echocardiograms . From January 2016 to December 2016 , TAVR with the next-generation self-exp and ing THV was attempted in 1,038 patients with symptomatic , severe AS at 53 centers on 4 continents . RESULTS Mean age was 81.8 ± 6.2 years , 64.9 % were women , the mean Society of Thoracic Surgeons Predicted Risk of Mortality was 5.5 ± 4.5 % , and 33.9 % of patients were deemed frail . The repositioning feature of the THV was applied in 25.8 % of patients . A single valve was implanted in the proper anatomic location in 98.9 % of patients . The mean aortic valve gradient was 8.5 ± 5.6 mm Hg , and moderate or severe aortic regurgitation was 1.9 % at discharge . All-cause mortality was 1.9 % , and disabling stroke occurred in 1.8 % at 30 days . The expected-to-observed early surgical mortality ratio was 0.35 . A pacemaker was implanted in 17.5 % of patients . CONCLUSIONS TAVR using the next-generation THV is clinical ly safe and effective for treating older patients with severe AS at increased operative risk . ( CoreValve Evolut R FORWARD Study [ FORWARD ] ; NCT02592369 )",
"AIMS Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System ( DFM-TAVS ) , when used in routine clinical practice . METHODS AND RESULTS This is a prospect i ve , open-label , multicentre , post-market registry of patients treated with DFM-TAVS according to approved commercial indications . Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee . The primary endpoint was freedom from all-cause mortality at 30 days post procedure . Secondary endpoints included procedural , early safety and efficacy endpoints at 30 days . Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation ( TAVI ) with the DFM-TAVS were enrolled in 21 European centres . The primary endpoint , freedom from all-cause mortality at 30 days , was met in 98 % ( 245/250 ) of patients . Device success was 83.8 % . Moderate or severe aortic regurgitation was reported in 3 % of patients , and none/trace regurgitation in 73 % of patients . Post-procedural permanent pacemaker implantation was performed in 30 patients ( 12.0 % ) . CONCLUSIONS The DFM-TAVS was associated with good short-term outcomes in this real-world registry . The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve ( THV )",
"AIMS This analysis aim ed to evaluate the incidence and predictors of the need for permanent pacemaker ( PPM ) implantation following implantation of the repositionable and fully retrievable LOTUS Aortic Valve Replacement System . METHODS AND RESULTS The prospect i ve , single-arm , multicentre REPRISE II study with extended cohort enrolled 250 symptomatic , high surgical risk patients with severe aortic stenosis for transfemoral transcatheter aortic valve implantation ( TAVI ) with a 23 mm or 27 mm LOTUS valve . Echocardiography , computed tomography , and electrocardiography data were evaluated by independent core labs . Post TAVI , 32.0 % ( 72/225 ) of pacemaker-naïve patients underwent new PPM implantation at 30 days . Most ( 59/72 , 82 % ) patients were implanted for third-degree atrioventricular block , and > 10 % overstretch of the LVOT by area was observed in 59.7 % ( 43/72 ) of PPM patients . Significant independent predictors of PPM at 30 days included baseline RBBB ( odds ratio [ OR ] 12.7 , 95 % CI : 4.5 , 36.2 ; p LVOT overstretch > 10 % ( OR 3.4 , 95 % CI : 1.7 , 6.7 ; p lower 30-day PPM rate in patients with a shallower ( ≤5 mm ) implant depth ( 23.9 % ≤5 mm vs. 36.9 % > 5 mm depth from LCS ; p=0.06 ) . CONCLUSIONS Careful attention to valve sizing and implant depth may help to reduce the rate of PPM with the LOTUS valve",
"OBJECTIVES This study sought to present the U.K. experience to date with the second-generation LOTUS bioprosthesis ( Boston Scientific , Natick , Massachusetts ) . BACKGROUND First-generation transcatheter aortic valves have limitations . Second-generation repositionable valves may improve on some of those limitations . METHODS Prospect ively collected data relating to procedural and in-hospital outcome was analyzed from 10 implantation centers in the United Kingdom . RESULTS Implants in 228 patients age 81.4 ± 7.6 years were studied ; 53.5 % were male . Mean logistic EuroScore was 17.5 ± 12.4 . One hundred eighty-seven ( 82.0 % ) were undertaken for aortic stenosis , 7 ( 3.1 % ) for aortic regurgitation , and 34 ( 14.9 % ) for mixed aortic valve disease . A total of 67.1 % of cases were done under local anesthetic and /or sedation with transfemoral access in 94.7 % and transaortic in 5.3 % . Three device sizes were used : 23 mm ( n = 66 , 28.9 % ) , 25 mm ( n = 39 , 17.1 % ) , and 27 mm ( n = 123 , 53.9 % ) . The valve was successfully deployed in 99.1 % of procedures . After implantation , the mean aortic gradient was 11.4 ± 5.4 mm Hg and aortic valve area 1.6 ± 0.5 cm(2 ) . In-hospital mortality was 1.8 % ( n = 4 ) . Complications included cardiac tamponade ( 1.8 % ) , conversion to sternotomy ( 1.3 % ) , stroke ( 3.9 % ) , vascular access-related ( 7.0 % ) , and acute kidney injury ( 7.9 % ) . The incidence of moderate/severe aortic regurgitation was 0.8 % ( n = 2 ) . A total of 31.8 % of patients required new permanent pacemaker implantation . CONCLUSIONS This analysis represents the largest published series on use of the LOTUS valve . Outcomes using this valve are excellent . In-hospital mortality is very low . Complication rates are low , and the LOTUS valve improves on first-generation valves , particularly with regard to residual aortic regurgitation",
"Background Transcatheter aortic valve implantation ( TAVI ) has emerged as a new therapeutic option in high-risk patients with severe aortic stenosis . Aims PARTNER EU is the first study to evaluate prospect ively the procedural and mid-term outcomes of transfemoral ( TF ) or transapical ( TA ) implantation of the Edwards SAPIEN ® valve involving a multi-disciplinary approach . Methods and results Primary safety endpoints were 30 days and 6 months mortality . Primary efficacy endpoints were haemodynamic and functional improvement at 12 months . One hundred and thirty patients ( 61 TF , 69 TA ) , aged 82.1 ± 5.5 years were included . TA patients had higher logistic EuroSCORE ( 33.8 vs. 25.7 % , P = 0.0005 ) and more peripheral disease ( 49.3 vs. 16.4 % , P Procedures were aborted in four TA ( 5.8 % ) and six TF cases ( 9.8 % ) . Valve implantation was successful in the remaining patients in 95.4 and 96.4 % , respectively . Thirty days and 6 months survival were 81.2 and 58.0 % ( TA ) and 91.8 and 90.2 % ( TF ) . In both groups , mean aortic gradient decreased from 46.9 ± 18.1 to 10.9 ± 5.4 mmHg 6 months post-TAVI . In total , 78.1 and 84.8 % of patients experienced significant improvement in New York Heart Association ( NYHA ) class , whereas 73.9 and 72.7 % had improved Kansas City Cardiomyopathy Question naire ( KCCQ ) scores in TA and TF cohorts , respectively . Conclusion This first team-based multi-centre European TAVI registry shows promising results in high-risk patients treated by TF or TA delivery . Survival rates differ significantly between TF and TA groups and probably reflect the higher risk profile of the TA cohort . Optimal patient screening , approach selection , and device refinement may improve outcomes",
"BACKGROUND We compared transcatheter aortic-valve replacement ( TAVR ) , using a self-exp and ing transcatheter aortic-valve bioprosthesis , with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery . METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center . Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors . Eligible patients were r and omly assigned in a 1:1 ratio to TAVR with the self-exp and ing transcatheter valve ( TAVR group ) or to surgical aortic-valve replacement ( surgical group ) . The primary end point was the rate of death from any cause at 1 year , evaluated with the use of both noninferiority and superiority testing . RESULTS A total of 795 patients underwent r and omization at 45 centers in the United States . In the as-treated analysis , the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group ( 14.2 % vs. 19.1 % ) , with an absolute reduction in risk of 4.9 percentage points ( upper boundary of the 95 % confidence interval , -0.4 ; P TAVR was noninferior with respect to echocardiographic indexes of valve stenosis , functional status , and quality of life . Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke . CONCLUSIONS In patients with severe aortic stenosis who are at increased surgical risk , TAVR with a self-exp and ing transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement . ( Funded by Medtronic ; U.S. CoreValve High Risk Study Clinical Trials.gov number , NCT01240902 . )",
"BACKGROUND Transcatheter aortic-valve implantation ( TAVI ) is an emerging intervention for the treatment of high-risk patients with severe aortic stenosis and coexisting illnesses . We report the results of a prospect i ve multicenter study of the French national transcatheter aortic-valve implantation registry , FRANCE 2 . METHODS All TAVIs performed in France , as listed in the FRANCE 2 registry , were prospect ively included in the study . The primary end point was death from any cause . RESULTS A total of 3195 patients were enrolled between January 2010 and October 2011 at 34 centers . The mean ( ±SD ) age was 82.7±7.2 years ; 49 % of the patients were women . All patients were highly symptomatic and were at high surgical risk for aortic-valve replacement . Edwards SAPIEN and Medtronic CoreValve devices were implanted in 66.9 % and 33.1 % of patients , respectively . Approaches were either transarterial ( transfemoral , 74.6 % ; subclavian , 5.8 % ; and other , 1.8 % ) or transapical ( 17.8 % ) . The procedural success rate was 96.9 % . Rates of death at 30 days and 1 year were 9.7 % and 24.0 % , respectively . At 1 year , the incidence of stroke was 4.1 % , and the incidence of periprosthetic aortic regurgitation was 64.5 % . In a multivariate model , a higher logistic risk score on the European System for Cardiac Operative Risk Evaluation ( EuroSCORE ) , New York Heart Association functional class III or IV symptoms , the use of a transapical TAVI approach , and a higher amount of periprosthetic regurgitation were significantly associated with reduced survival . CONCLUSIONS This prospect i ve registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis , in whom TAVI appeared to be a reasonable option . ( Funded by Edwards Lifesciences and Medtronic . )",
"Background Conduction disorders requiring permanent pacemaker ( PPM ) implantation are a known complication of transcatheter aortic valve implantation ( TAVI ) . Indications for permanent pacing in this setting are still controversial . The study aim was to characterize the natural history of conduction disorders related to TAVI , and to identify predictors for long‐term pacing dependency . Methods Consecutive patients who underwent TAVI were included in this prospect i ve observational study . The conduction system was investigated by review ing 12‐lead ECGs during hospitalization and up to 1‐year follow‐up and by analyzing pacemaker interrogation data . Multivariate analysis was performed in order to identify independent predictors for pacemaker dependency . Results Of 110 patients included in the analysis , 38 ( 34.5 % ) underwent PPM implantation . Of those , 26 ( 68.4 % ) had a long‐term pacing dependency ( required PPM ) , while 12 ( 31.6 % ) did not ( not‐required PPM ) . Logistic regression revealed that baseline RBBB ( P = 0.01 , OR = 18.0 ) , baseline PR interval ( P = 0.019 , OR = 1.14 ) , post‐TAVI PR interval and the change in PR interval from baseline ( P A PR interval increment of greater than 28 milliseconds had the best accuracy in predicting pacemaker dependency . Conclusions Increased pre‐ and postprocedural PR intervals and pre‐existing RBBB are reliable predictors for long‐term PPM dependency , while left bundle branch block or QRS width are misleading factors . Our study suggests that the decision for implanting PPM after TAVI should be based mostly on the prolongation of the PR interval ",
"OBJECTIVES The aim of this study was : 1 ) to evaluate the acute and late outcomes of a transcatheter aortic valve implantation ( TAVI ) program including both the transfemoral ( TF ) and transapical ( TA ) approaches ; and 2 ) to determine the results of TAVI in patients deemed inoperable because of either porcelain aorta or frailty . BACKGROUND Very few data exist on the results of a comprehensive TAVI program including both TA and TF approaches for the treatment of severe aortic stenosis in patients at very high or prohibitive surgical risk . METHODS Consecutive patients who underwent TAVI with the Edwards valve ( Edwards Lifesciences , Inc. , Irvine , California ) between January 2005 and June 2009 in 6 Canadian centers were included . RESULTS A total of 345 procedures ( TF : 168 , TA : 177 ) were performed in 339 patients . The predicted surgical mortality ( Society of Thoracic Surgeons risk score ) was 9.8 + /- 6.4 % . The procedural success rate was 93.3 % , and 30-day mortality was 10.4 % ( TF : 9.5 % , TA : 11.3 % ) . After a median follow-up of 8 months ( 25th to 75th interquartile range : 3 to 14 months ) the mortality rate was 22.1 % . The predictors of cumulative late mortality were peri-procedural sepsis ( hazard ratio [ HR ] : 3.49 , 95 % confidence interval [ CI ] : 1.48 to 8.28 ) or need for hemodynamic support ( HR : 2.58 , 95 % CI : 1.11 to 6 ) , pulmonary hypertension ( PH ) ( HR : 1.88 , 95 % CI : 1.17 to 3 ) , chronic kidney disease ( CKD ) ( HR : 2.30 , 95 % CI : 1.38 to 3.84 ) , and chronic obstructive pulmonary disease ( COPD ) ( HR : 1.75 , 95 % CI : 1.09 to 2.83 ) . Patients with either porcelain aorta ( 18 % ) or frailty ( 25 % ) exhibited acute outcomes similar to the rest of the study population , and porcelain aorta patients tended to have a better survival rate at 1-year follow-up . CONCLUSIONS A TAVI program including both TF and TA approaches was associated with comparable mortality as predicted by surgical risk calculators for the treatment of patients at very high or prohibitive surgical risk , including porcelain aorta and frail patients . Baseline ( PH , COPD , CKD ) and peri-procedural ( hemodynamic support , sepsis ) factors but not the approach determined worse outcomes",
"Background Conduction disorders and permanent pacemaker ( PPM ) implantation are common complications in patients undergoing transcatheter aortic valve implantation ( TAVI ) . Previous studies , evaluating small population s , have identified several different predictors of PPM implantation after TAVI . The aim of this study was to assess the incidence rate of conduction disorders and the predictors of postoperative PPM requirement in a large series of patients undergoing TAVI . Methods Data were analyzed from 181 consecutive patients at high-risk surgery who underwent TAVI at our institute between July 2007 and April 2011 . All patients underwent implantation of the third-generation percutaneous self-exp and ing CoreValve ® prosthesis ( CoreValve , Inc. , Irvine , CA , USA ) . In all patients , a 12-lead electrocardiogram and a 24-h holter monitoring was recorded before and after the procedure in order to assess the presence of conduction disorders . Clinical data , preoperative conduction disorders , echocardiographic patterns , and procedural data were tested as predictors of PPM implantation after TAVI . Results Left bundle branch block ( LBBB ) was the most common conduction disorder , with an incidence of 50.3 % at discharge . Fifty-two ( 32.1 % ) patients developed a persistent complete AVB requiring PPM implantation . PPM implantation was strongly correlated with the presence of preoperative right bundle branch block ( RBBB ) which was found to be the only independent predictor of PPM implantation ( HR 16.5 , CI 3.3–82.3 , p LBBB and PPM implantation requirement after TAVI are common occurrences using the self-exp and ing CoreValve prosthesis . In this large series of consecutive patients , only RBBB was found to be a strong predictor of PPM requirement",
"AIMS This study sought to investigate outcomes of transcatheter aortic valve implantation ( TAVI ) with the SAPIEN 3 transcatheter heart valve ( THV ) in patients at intermediate risk for surgery . The 30-day results of the transfemoral cohort are reported . METHODS AND RESULTS The SAPIEN 3 European approval trial intermediate-risk cohort included a total of 101 patients with severe , symptomatic aortic stenosis , at intermediate risk for surgery suitable for TAVI via the transfemoral route ( TF ) . Outcomes were adjudicated by a clinical events committee . Echocardiography , computed tomography and electrocardiography exams were analysed in core laboratories . The mean STS-PROM score and logistic EuroSCORE of the study population were 5.2±1.7 and 13.2±3.8 , respectively . A completely percutaneous procedure was performed in 90.1 % of patients and conscious sedation and /or local anaesthesia was utilised in 54.5 % . Technical success was achieved in 98.0 % of patients . At 30 days , mortality was 1.0 % , with stroke in 3.0 % and a new permanent pacemaker in 4.0 % ( 4.3 % of patients without pre-procedural permanent pacemaker ) . No patients had severe aortic regurgitation after the procedure , only one patient had moderate aortic regurgitation , and 70.8 % of patients had no or trace aortic regurgitation . CONCLUSIONS TF-TAVI using the SAPIEN 3 THV in patients at intermediate risk for surgery is associated with a very low risk of death and complications , including new pacemakers and paravalvular leaks . Although compelling , these initial results are being confirmed in larger global studies before exp and ing the indications for TAVI in severe aortic stenosis",
"OBJECTIVES The aim of this study was to evaluate the short-term safety and performance of the full range of valve sizes offered within the Portico transcatheter aortic valve replacement system . BACKGROUND The Portico transcatheter aortic heart valve is a fully resheathable , repositionable , and self-exp and ing bioprosthesis design ed to achieve optimal valve position and hemodynamic performance and limit conduction disturbances . METHODS Patients ( n = 222 ) with symptomatic ( New York Heart Association functional class ≥II ) severe aortic stenosis considered by a multidisciplinary heart team to be at high surgical risk were recruited between December 2011 and September 2015 in this prospect i ve , nonr and omized , multicenter study . Patients were implanted with the full range of Portico heart valves ( 23 , 25 , 27 , and 29 mm ) using the transfemoral approach . The primary endpoint was all-cause mortality at 30 days . Secondary endpoints included valve performance , improvement in functional class , and procedural outcomes as defined by Valve Academic Research Consortium criteria . RESULTS A total of 220 patients ( mean age 83.0 ± 4.6 years , 74.3 % women , mean Society of Thoracic Surgeons score 5.8 % ) had valves implanted . All resheathing and repositioning attempts ( n = 72 ) were successful . At 30 days , all-cause mortality was 3.6 % . Procedural outcomes included disabling ( major ) stroke ( 3.2 % ) , major vascular complications ( 7.2 % ) , and permanent pacemaker implantation ( 13.5 % ) . Compared with baseline , 75.8 % of patients improved by ≥1 New York Heart Association functional class at 30 days . The rate of moderate paravalvular leak was 5.7 % , with no severe paravalvular leak reported . No differences in paravalvular leak incidence and severity were observed among valve sizes ( p = 0.24 ) . CONCLUSIONS Across all valve sizes , use of the repositionable Portico transcatheter aortic valve replacement system result ed in safe and effective treatment of aortic stenosis in high-risk patients",
"AIMS Data on procedural and clinical outcomes after transcatheter aortic valve implantation ( TAVI ) with the new-generation self-exp and ing Medtronic Evolut R prosthesis in comparison with its predecessor , the Medtronic CoreValve , are scarce . The aim of this study was to assess the safety and efficacy of the Evolut R device compared with the former-generation CoreValve . METHODS AND RESULTS In a nationwide , prospect i ve , multicentre cohort study , outcomes of consecutive transfemoral TAVI patients treated with the new-generation Medtronic Evolut R ( September 2014 - February 2016 ) and the Medtronic CoreValve ( February 2011 - February 2016 ) were investigated . Events were reported according to VARC-2 and adjudicated by a clinical events committee . During the study period , 317 and 678 consecutive patients underwent TAVI with the Evolut R and the CoreValve bioprosthesis , respectively . Baseline clinical characteristics between the groups were comparable , although Evolut R patients were lower risk according to the STS score ( 4.8±3.4 % vs. 6.9±5.0 % , p and logistic EuroSCORE ( 17.3±13 % vs. 20.1±13 % , p=0.009 ) . Implantation of the Evolut R was associated with a lower use of predilatation ( 48.1 % vs. 72.4 % , p shorter procedure time ( 67.9±36 min vs. 76.7±42 min , p=0.002 ) , and less contrast dye use during the procedure ( 155.2±98 ml vs. 208.0±117 ml , p gradient was comparable ( 7.4±4.7 mmHg vs. 7.5±5.0 mmHg ) , as were the 30-day rates of moderate to severe aortic regurgitation ( 8.5 % vs. 10.5 % ) , major vascular ( 9.8 % vs. 10.3 % ) and life-threatening bleeding complications ( 5.4 % vs. 5.3 % ) , disabling stroke ( 1.9 % vs. 1.6 % ) , all-cause mortality ( 3.2 % vs. 3.4 % ) as well as permanent pacemaker implantation ( 22.1 % vs. 23.4 % ) . CONCLUSIONS Thirty-day clinical outcomes were favourable and comparable between the Evolut R and the CoreValve bioprosthesis",
"OBJECTIVES Transcatheter aortic valve implantation ( TAVI ) is an established intervention for aortic stenosis . While it is known that the requirement for permanent pacing is higher following CoreValve ( Medtronic , Inc. , Minneapolis , MN , USA ) TAVI than after surgical aortic valve replacement ( SAVR ) , it remains uncertain whether pacing is required in the medium-to-long term . We hypothesized that complete heart block following TAVI is more likely to resolve than that following SAVR . METHODS A retrospective analysis of prospect ively collated data on 528 patients undergoing TAVI or SAVR from May 2008 to December 2010 at a cardiac tertiary referral hospital . Demographic data , timing and indication for pacing post-procedure plus follow-up were recorded . Paced patients were compared and analysed by existing initial indication for pacing . RESULTS In total , 31 ( 5.9 % ) patients received a pacemaker , and there were limited differences between not paced and paced patient characteristics by procedure type . Of these , a greater proportion were implanted post-TAVI compared with SAVR ( 17 vs 3.2 % , P mean time to pacemaker follow-up for TAVI and SAVR was 234 and 188 days , P=0.32 , respectively . Fewer patients compared with pacing indication remained in complete heart block at latest follow-up for TAVI ( 76.5 vs 33.3 % , P=0.02 ) and SAVR ( 92.9 vs 58.3 % , P=0.04 ) . Although , there was a trend towards a greater magnitude of TAVI patients regaining atrioventricular nodal conduction , this did not differ significantly from that seen in SAVR patients . CONCLUSIONS In keeping with previous reports , this single-centre experience demonstrates that patients undergoing TAVI have higher rates of pacemaker implantation than those following SAVR . However , pacing indication in the short-to-medium term may not persist for all paced patients post-TAVI and -SAVR with the suggestion that a significant proportion recover atrioventricular conduction , which tended to be greatest in TAVI paced patients",
"OBJECTIVES The study sought a prospect i ve multicenter nonr and omized evaluation of the Direct Flow Medical ( DFM ) system for the treatment of severe aortic stenosis . BACKGROUND The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning , retrieval , and assessment of valve performance prior to permanent implantation . METHODS One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint . There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase . Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium ( VARC ) criteria . RESULTS There was 99 % freedom from all cause mortality at 30 days ( primary endpoint ) . VARC criteria defined 30 day combined freedom from patient safety event rate was 91 % and overall device success was 93 % . The post-implantation echocardiography results demonstrated mild or no aortic regurgitation in 99 % ( 73 of 74 ) with a mean gradient of 12.6 ± 7.1 mm Hg ( n = 72 ) and effective orifice area of 1.50 ± 0.56 cm(2 ) and New York Heart Association functional class was I or II in 92 % of cases . CONCLUSIONS The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99 % of patients",
"BACKGROUND The SAPIEN 3 ( Edwards Lifesciences Inc. , Irvine , California ) transcatheter valve incorporates features design ed to address the well-known deficiencies of transcatheter aortic valve replacement ( TAVR ) . An ultra-low-profile delivery system facilitates safe , controlled , and accurate implantation and an external seal minimizes paravalvular regurgitation . OBJECTIVES The study evaluated whether TAVR with this third-generation valve would be a viable alternative to high- or intermediate-risk surgery for severe aortic stenosis . METHODS The prospect i ve study enrolled 150 patients at 16 sites in Europe and Canada . Clinical and echocardiographic outcomes were assessed at baseline , post-procedure , and 30 days . New sizing recommendations were developed during the course of the study . RESULTS Patients were 83.6 ± 5.0 years of age , with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4 ± 4.5 % and logistic EuroSCORE of 21.6 ± 12.3 % . A transfemoral approach was chosen in 64.0 % and alternative access ( transapical/direct aortic ) in the remainder . At 30 days , paravalvular regurgitation was none to mild in 96.4 % and moderate in 3.5 % . No patient had severe regurgitation . Transfemoral implantation was associated with low mortality ( 2.1 % ) , no disabling stroke ( 0.0 % ) , and fully percutaneous access and closure in 95.8 % . Nontransfemoral alternative access was associated with higher rates of mortality ( 11.6 % ) and stroke ( 5.6 % ) . CONCLUSIONS This third-generation device addresses major deficiencies of earlier valves in terms of ease of use , accuracy of positioning , and paravalvular sealing . The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients . ( Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve [ SAPIEN3 ] ; NCT01808287 )",
"OBJECTIVES This study sought to develop a robust and definitive risk model for new permanent pacemaker implantation ( PPMI ) after SAPIEN 3 ( third generation balloon exp and able valve ) ( Edwards Lifesciences , Irvine , California ) transcatheter aortic valve replacement ( third generation balloon exp and able valve TAVR ) , including calcification in the aortic-valvular complex ( AVC ) . BACKGROUND The association between calcium in the AVC and need for PPMI is poorly delineated after third generation balloon exp and able valve TAVR . METHODS At Cedars-Sinai Heart Institute in Los Angeles , California , a total of 240 patients with severe aortic stenosis underwent third generation balloon exp and able valve TAVR and had contrast computed tomography . AVC was characterized precisely by leaflet sector and region . RESULTS The total new PPMI rate was 14.6 % . On multivariate analysis for predictors of PPMI , pre-procedure third generation balloon exp and able valve TAVR , right bundle branch block ( RBBB ) , shorter membranous septum ( MS ) length , and noncoronary cusp device-l and ing zone calcium volume ( NCC-DLZ CA ) were included . Predictive probabilities were generated using this logistic regression model . If 3 pre-procedural risk factors were present , the c-statistic of the model for PPMI was area under the curve of 0.88 , sensitivity of 77.1 % , and specificity of 87.1 % ; this risk model had high negative predictive value ( 95.7 % ) . The addition of the procedural factor of device depth to the model , with the parameter of difference between implantation depth and MS length , combined with RBBB and NCC-DLZ CA increased the c-statistic to 0.92 , sensitivity to 94.3 % , specificity to 83.8 % , and negative predictive value to 98.8 % CONCLUSIONS : By using a precise characterization of distribution of calcification in the AVC in a single-center , retrospective study , NCC-DLZ CA was found to be an independent predictor of new PPMI post-third generation balloon exp and able valve TAVR . The findings also reinforce the importance of short MS length , pre-existing RBBB , and ventricular implantation depth as important synergistic PPMI risk factors . This risk model will need validation by future prospect i ve multicenter studies",
"OBJECTIVES Transcatheter aortic valve replacement ( TAVR ) is an established therapy for patients with aortic stenosis ( AS ) at high surgical risk . The JenaValve ™ is a second-generation , self-exp and ing transcatheter heart valve ( THV ) , implanted through transapical access ( TA ) . During stent deployment , a specific ' clipping-mechanism ' engages native aortic valve cusps for fixation . We present 1-year outcomes of the JUPITER registry , a post-market registry of the JenaValve for TA-TAVR . METHODS The JUPITER registry is a prospect i ve , multicentre , uncontrolled and observational European study to evaluate the long-term safety and effectiveness of the Conformité Européenne-marked JenaValve THV . A total of 180 patients with AS were enrolled between 2012 and 2014 . End-points were adjudicated in accordance with the valve academic research consortium document no. 1 definitions . RESULTS The mean age was 80.4 ± 5.9 years and the mean logistic European system for cardiac operative risk evaluation I 21.2 ± 14.7 % . The procedure was successful in 95.0 % ( 171/180 ) , implantation of a second THV ( valve-in-valve ) was performed in 2.2 % ( 4/180 ) and conversion to surgical aortic valve replacement ( SAVR ) was necessary in 2.8 % ( 5/180 ) . No annular rupture or coronary ostia obstruction occurred . Two patients required SAVR after the day of index procedure ( 1.1 % ) . All-cause mortality at 30 days was 11.1 % ( 20/180 ) , being cardiovascular in 7.2 % ( 13/180 ) . A major stroke occurred in 1.1 % ( 2/180 ) at 30 days , no additional major strokes were observed during 1 year . All-cause mortality after 30 days was 13.1 % ( 21/160 ) and combined efficacy at 1 year was 80.8 % ( 122/151 ) . At 1-year follow-up , no patient presented with more than moderate paravalvular leakage , while 2 patients ( 3.2 % ) showed moderate , 12 ( 19.0 % ) mild and 49 ( 82.4 % ) trace/none paravalvular regurgitation . CONCLUSIONS In a high-risk cohort of patients undergoing TA-TAVR for AS , the use of the JenaValve THV is safe and effective . In patients at higher risk for coronary ostia obstruction , annular rupture or with limited aortic valve calcification , the JenaValve might be preferable for implantation due to its clipping-mechanism engaging native aortic valve cusps for fixation with reduced radial forces of the self-exp and ing stent",
"Background Predictors for the need of permanent pacemaker implantation ( PPMI ) in the context of transcatheter aortic valve implantation ( TAVI ) are not well defined yet . We evaluated the impact of conduction disturbances , calcium volume of the device l and ing zone , oversizing and implantation depth on PPMI after TAVI with the balloon-exp and able Edwards Sapien 3 ( ES3 ) . Methods and results 335 consecutive patients undergoing transfemoral TAVI with the ES3 for the treatment of symptomatic severe aortic stenosis were included ( clinical trials NCT02162069 ) . Rate of PPMI after TAVI was 18.4 % , excluding patients with permanent pacemakers prior to TAVI or valve-in-valve implantations . Patients requiring PPMI more often had first degree atrioventricular block ( AVB ) at baseline ( 48.7 vs. 16.5 % , p complete right bundle branch block ( RBBB ; 25.0 vs. 3.9 % , p higher calcium volume of the aortic valve ( 258.5 ± 317.3 vs. 163.6 ± 178.8 mm³ , p higher rate of PPMI in patients with new-onset left bundle branch block after TAVI ( 32.7 vs. 20.7 % , p = 0.06 ) . Multivariate logistic regression analysis showed that baseline first degree AVB ( odds ratio 3.9 , 95 % confidence interval 1.73–9.10 , p neither oversizing nor implantation depth were independent predictors for need of PPMI with the ES3 . Conclusions In patients treated with the ES3 for symptomatic severe aortic stenosis first degree AVB and complete RBBB at baseline were independently associated with higher rates of postprocedural PPMI , whereas implantation depth and oversizing did not have an impact on PPMI",
"We report clinical outcomes following transcatheter aortic valve implantation ( TAVI ) , using the CoreValve revalving system ( 18 Fr transfemoral or subclavian ) or the Edwards Sapien valve ( 22 Fr transfemoral or 24 Fr transapical ) as part of a Belgian prospect i ve non-r and omized multicentre registry . All 15 Belgian centres performing TAVI participated to this registry ( seven exclusively Edwards Sapien , eight exclusively CoreValve ) . All consecutive high-risk symptomatic patients with severe aortic stenosis were evaluated by a heart team and screened for eligibility for TAVI . Three hundred and twenty-eight patients underwent TAVI with CoreValve ( n = 141 ; eight subclavian and 133 transfemoral ) or Edwards Sapien ( n = 187 ; 99 transfemoral and 88 transapical ) up to April 2010 . Procedural success was 97 % . One-month survival was 88 % for the Edwards and 89 % for the CoreValve treated patients . One-month mortality was both related to cardiac and non-cardiac reasons . Overall one-year survival was 78 % in the CoreValve transfemoral treated patients , 100 % in the CoreValve subclavian treated patients , 82 % in the Edwards transfemoral treated patients and 63 % in the Edwards transapical treated patients . This mid-term mortality was mainly related to age-related , non-cardiac complications",
"BACKGROUND Previous trials have shown that among high-risk patients with aortic stenosis , survival rates are similar with transcatheter aortic-valve replacement ( TAVR ) and surgical aortic-valve replacement . We evaluated the two procedures in a r and omized trial involving intermediate-risk patients . METHODS We r and omly assigned 2032 intermediate-risk patients with severe aortic stenosis , at 57 centers , to undergo either TAVR or surgical replacement . The primary end point was death from any cause or disabling stroke at 2 years . The primary hypothesis was that TAVR would not be inferior to surgical replacement . Before r and omization , patients were entered into one of two cohorts on the basis of clinical and imaging findings ; 76.3 % of the patients were included in the transfemoral-access cohort and 23.7 % in the transthoracic-access cohort . RESULTS The rate of death from any cause or disabling stroke was similar in the TAVR group and the surgery group ( P=0.001 for noninferiority ) . At 2 years , the Kaplan-Meier event rates were 19.3 % in the TAVR group and 21.1 % in the surgery group ( hazard ratio in the TAVR group , 0.89 ; 95 % confidence interval [ CI ] , 0.73 to 1.09 ; P=0.25 ) . In the transfemoral-access cohort , TAVR result ed in a lower rate of death or disabling stroke than surgery ( hazard ratio , 0.79 ; 95 % CI , 0.62 to 1.00 ; P=0.05 ) , whereas in the transthoracic-access cohort , outcomes were similar in the two groups . TAVR result ed in larger aortic-valve areas than did surgery and also result ed in lower rates of acute kidney injury , severe bleeding , and new-onset atrial fibrillation ; surgery result ed in fewer major vascular complications and less paravalvular aortic regurgitation . CONCLUSIONS In intermediate-risk patients , TAVR was similar to surgical aortic-valve replacement with respect to the primary end point of death or disabling stroke . ( Funded by Edwards Lifesciences ; PARTNER 2 Clinical Trials.gov number , NCT01314313 . )",
"Background Although transcatheter aortic‐valve replacement ( TAVR ) is an accepted alternative to surgery in patients with severe aortic stenosis who are at high surgical risk , less is known about comparative outcomes among patients with aortic stenosis who are at intermediate surgical risk . Methods We evaluated the clinical outcomes in intermediate‐risk patients with severe , symptomatic aortic stenosis in a r and omized trial comparing TAVR ( performed with the use of a self‐exp and ing prosthesis ) with surgical aortic‐valve replacement . The primary end point was a composite of death from any cause or disabling stroke at 24 months in patients undergoing attempted aortic‐valve replacement . We used Bayesian analytical methods ( with a margin of 0.07 ) to evaluate the noninferiority of TAVR as compared with surgical valve replacement . Results A total of 1746 patients underwent r and omization at 87 centers . Of these patients , 1660 underwent an attempted TAVR or surgical procedure . The mean ( ±SD ) age of the patients was 79.8±6.2 years , and all were at intermediate risk for surgery ( Society of Thoracic Surgeons Predicted Risk of Mortality , 4.5±1.6 % ) . At 24 months , the estimated incidence of the primary end point was 12.6 % in the TAVR group and 14.0 % in the surgery group ( 95 % credible interval [ Bayesian analysis ] for difference , ‐5.2 to 2.3 % ; posterior probability of noninferiority , > 0.999 ) . Surgery was associated with higher rates of acute kidney injury , atrial fibrillation , and transfusion requirements , whereas TAVR had higher rates of residual aortic regurgitation and need for pacemaker implantation . TAVR result ed in lower mean gradients and larger aortic‐valve areas than surgery . Structural valve deterioration at 24 months did not occur in either group . Conclusions TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk , with a different pattern of adverse events associated with each procedure . ( Funded by Medtronic ; SURTAVI Clinical Trials.gov number , NCT01586910 .",
"BACKGROUND / OBJECTIVES To determine pacemaker ( PM ) dependency at follow-up visit in patients who underwent new permanent pacemaker implantation ( PPI ) following transcatheter aortic valve implantation ( TAVI ) . METHODS Single center prospect i ve observational study including 167 patients without previous PM implantation who underwent TAVI with the self-exp and ing Medtronic CoreValve System ( MCS ) between November 2005 and February 2011 . PM dependency was defined by the presence of a high degree atrioventricular block ( HDAVB ; second [ AV2 ] and third degree [ AV3B ] ) , or a slow ( ventricular escape rhythm during follow-up PM interrogation . RESULTS A total of 36 patients ( 21.6 % ) received a new PM following TAVI . The indication for PM was AV2B ( n=2 , 5.6 % ) , AV3B ( n=28 , 77.8 % ) , postoperative symptomatic bradycardia ( n=3 , 8.3 % ) , brady-tachy syndrome ( n=1 , 2.8 % ) , atrial fibrilation with slow response ( n=1 , 2.8 % ) and left bundle branch block ( n=1 , 2.8 % ) . Long term follow-up was complete for all patients and ranged from 1 to 40 months ( median ( IQR ) : 11.5 ( 5.0 - 18.0 months ) . Of those patients with a HDAVB , 16 out of the 30 patients ( 53.3 % ) were PM independent at follow-up visit ( complete or partial resolution of the AV conduction abnormality ) . Overall , 20 out of the 36 patients ( 55.6 % ) who received a new PM following TAVI were PM independent at follow-up . CONCLUSION Partial and even complete resolution of peri-operative AV conduction abnormalities after MCS valve implantation occurred in more than half of the patients",
"OBJECTIVES This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve ( THV ) for the treatment of severe aortic stenosis in patients at extreme risk for surgery . BACKGROUND Untreated severe aortic stenosis is a progressive disease with a poor prognosis . Transcatheter aortic valve replacement ( TAVR ) with a self-exp and ing bioprosthesis is a potentially effective therapy . METHODS We performed a prospect i ve , multicenter , nonr and omized investigation evaluating the safety and efficacy of self-exp and ing TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery . The primary endpoint was a composite of all-cause mortality or major stroke at 12 months , which was compared with a pre-specified objective performance goal ( OPG ) . RESULTS A total of 41 sites in the United States recruited 506 patients , of whom 489 underwent attempted treatment with the CoreValve THV . The rate of all-cause mortality or major stroke at 12 months was 26.0 % ( upper 2-sided 95 % confidence bound : 29.9 % ) versus 43.0 % with the OPG ( p all-cause mortality ( 8.4 % and 24.3 % , respectively ) and major stroke ( 2.3 % and 4.3 % , respectively ) . Procedural events at 30 days included life-threatening/disabling bleeding ( 12.7 % ) , major vascular complications ( 8.2 % ) , and need for permanent pacemaker placement ( 21.6 % ) . The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-exp and ing TAVR ( 4.2 % ) than at discharge ( 10.7 % ; p = 0.004 for paired analysis ) . CONCLUSIONS TAVR with a self-exp and ing bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement . ( Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement ; NCT01240902 )",
"To determine predictors of permanent pacemaker ( PPM ) implantation up to 30 days after transcatheter aortic valve implantation ( TAVI ) in a prospect i ve multicenter registry",
"OBJECTIVES The authors present the UK and Irish real-world learning curve experience of the Evolut R transcatheter heart valve . BACKGROUND The Evolut R is a self-exp and ing , repositionable , and fully recapturable second-generation transcatheter heart valve with several novel design features to improve outcomes and reduce complications . METHODS Clinical , procedural , and 30-day outcome data were prospect ively collected for the first 264 patients to receive the Evolut R valve in the United Kingdom and Irel and . RESULTS A total of 264 consecutive Evolut R implantations were performed across 9 centers . The mean age was 81.1 ± 7.8 years , and the mean logistic European System for Cardiac Operative Risk Evaluation score was 19.9 ± 13.7 % . Procedural indications included aortic stenosis ( 72.0 % ) , mixed aortic valve disease ( 17.4 % ) , and failing aortic valve bioprostheses ( 10.6 % ) . Conscious sedation was used in 39.8 % of patients and transfemoral access in 93.6 % . The procedural success rate was 91.3 % , and paravalvular leak immediately after implantation was mild or less in 92.3 % . Major complications were rare : cardiac tamponade in 0.4 % , conversion to sternotomy in 0.8 % , annular rupture in 0.0 % , coronary occlusion in 0.8 % , major vascular in 5.3 % , acute kidney injury in 6.1 % , new permanent pacemaker implantation in 14.7 % , and procedure-related death in 0.0 % . At 30-day follow-up , survival was 97.7 % , paravalvular leak was mild or less in 92.3 % , and the stroke rate was 3.8 % . CONCLUSIONS This registry represents the largest published real-world experience of the Evolut R valve . The procedural success rate was high and safety was excellent , comparable with previous studies of the Evolut R valve and other second-generation devices . The low rate of complications represents an improvement on first-generation devices",
"The aim of the study was to determine the incidence of permanent pacemaker implantation ( PPMI ) in a cohort of 358 patients undergoing transapical aortic valve implantation ( TAVI ) using a balloon-exp and able prosthesis between April 2008 and March 2011 . After excluding patients who had had a previous PPMI ( n=36 ; 10 % ) , the study group consisted of 322 patients . These were divided into two groups : patients who required PPMI ( PPM group ) and patients who did not require it ( non-PPM group ) . Preoperative , perioperative and one-year follow-up data were collected prospect ively . Twenty ( 6.2 % ) patients required PPMI . Previous implantation of an aortic prosthesis ( P = non-significant ) , previous coronary artery bypass grafting ( P=0.05 ) and coronary artery disease ( P survival rate between the groups after 30 days ( PPM group 95 % , non-PPM group 93.6 % ) . Similarly , the survival rate did not differ after one year ( PPM group 84 % , non-PPM group 80.9 % ; P=0.3 ) . The PPMI rate after transapical TAVI using a balloon-exp and able prosthesis is thus low , and has no impact on early and follow-up mortality"
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BACKGROUND Type 2 Diabetes Mellitus ( T2DM ) is reported to affect one in 11 adults worldwide , with over 80 % of T2DM patients residing in low-to-middle-income countries . Health systems play an integral role in responding to this increasing global prevalence , and are key to ensuring effective diabetes management . We conducted a systematic review to examine the health system-level factors influencing T2DM awareness , treatment , adherence , and control . METHODS AND FINDINGS A protocol for this study was published on the PROSPERO international prospect i ve register of systematic review s ( PROSPERO 2016 : CRD42016048185 ) . Studies included in this review reported the effects of health systems factors , interventions , policies , or programmes on T2DM control , awareness , treatment , and adherence . The following data bases were search ed on 22 February 2017 : Medline , Embase , Global health , LILACS , Africa-Wide , IMSEAR , IMEMR , and WPRIM . There were no restrictions on date , language , or study design s. Two review ers independently screened studies for eligibility , extracted the data , and screened for risk of bias . Thereafter , we performed a narrative synthesis . A meta- analysis was not conducted due to method ological heterogeneity across different aspects of included studies . 93 studies were included for qualitative synthesis ; 7 were conducted in LMICs . Through this review , we found two key health system barriers to effective T2DM care and management : financial constraints faced by the patient and limited access to health services and medication . We also found three health system factors that facilitate effective T2DM care and management : the use of innovative care models , increased pharmacist involvement in care delivery , and education programmes led by healthcare professionals . CONCLUSIONS This review points to the importance of reducing , or possibly eliminating , out-of-pocket costs for diabetes medication and self-monitoring supplies . It also points to the potential of adopting more innovative and integrated models of care , and the value of task-sharing of care with pharmacists . More studies which identify the effect of health system arrangements on various outcomes , particularly awareness , are needed | [
"The effect of pharmaceutical care on the prevention , detection , and resolution of medication-related problems in high-risk patients in a rural community was studied . Adult patients who received care at clinics in a medically underserved area of Alabama and who were identified as being at high risk of medication-related adverse events were r and omly assigned to a control group or an intervention group . The control group received st and ard medical care , and the intervention group received pharmaceutical care , including a medical record review , a medication history review , pharmacotherapeutic evaluation , and patient medication education and monitoring over a one-year period . A total of 69 patients completed the study ( 33 in the intervention group and 36 in the control group ) . The percentage of patients responding to hypertension , diabetes , dyslipidemia , and anticoagulation therapy increased significantly in the intervention group and declined in the control group . Ratings for inappropriate prescribing improved in all 10 domains evaluated in the intervention group but worsened in 5 domains in the control group . There were no significant differences between the groups at 12 months in health-related quality of life or medication misadventures . Medication compliance scores improved in the intervention group but not in the control group . Medication knowledge increased in the intervention group and decreased in the control group . Pharmaceutical care in a rural , community-based setting appeared to reduce inappropriate prescribing , enhance disease management , and improve medication compliance and knowledge without adversely affecting health-related quality of life",
"Background — Even in high-performing health systems , some patients with diabetes mellitus have poor blood pressure ( BP ) control because of poor medication adherence and lack of medication intensification . We examined whether the Adherence and Intensification of Medications intervention , a pharmacist-led intervention combining elements found in efficacy studies to lower BP , improved BP among patients with diabetes mellitus with persistent hypertension and poor refill adherence or insufficient medication intensification in 2 high-performing health systems . Methods and Results — We conducted a prospect i ve , multisite cluster r and omized pragmatic trial with r and omization of 16 primary care teams at 5 medical centers ( 3 Veterans Affairs and 2 Kaiser Permanente ) to the Adherence and Intensification of Medications intervention or usual care . The primary outcome was relative change in systolic BP ( SBP ) , comparing 1797 intervention with 2303 control team patients , from 6 months preceding to 6 months after the 14-month intervention period . We examined shorter-term changes in SBP as a secondary outcome . The mean SBP decrease from 6 months before to 6 months after the intervention period was ≈9 mm Hg in both arms . Mean SBPs of eligible intervention patients were 2.4 mm Hg lower ( 95 % CI : −3.4 to −1.5 ; P Adherence and Intensification of Medications program more rapidly lowered SBPs among intervention patients , but usual-care patients achieved equally low SBP levels by 6 months after the intervention period . These findings show the importance of evaluating in different real-life clinical setting s programs found in efficacy trials to be effective before urging their widespread adoption in all setting s. Clinical Trial Registration — URL : http:// clinical trials.gov . Unique identifier : NCT00495794",
"Purpose To assess whether VA MEDIC-E ( Veterans Affairs Multi-disciplinary Education and Diabetes Intervention for Cardiac risk reduction[EM DASH ] Extended for 6 months ) , a pharmacist-led shared medical appointments program , could improve attainment of target goals for hypertension , hyperglycemia , hyperlipidemia , and tobacco use in patients with type 2 diabetes compared to st and ard primary care after 6 months of intervention . Methods A r and omized , controlled trial of VA MEDIC-E ( n = 50 ) versus st and ard primary care ( n = 49 ) in veterans with type 2 diabetes , hemoglobin A1c ( A1C ) > 7 % , blood pressure ( BP ) > 130/80 mmHg , and low density lipoprotein cholesterol ( LDL-C ) > 100mg/dl ( 2.59 mmol/l ) in the previous 6 months was conducted . The VA MEDIC-E intervention consisted of 4 weekly group sessions followed by 5 monthly booster group sessions . Each 2-hour session included 1 hour of multidisciplinary diabetes specific healthy lifestyle education and 1 hour of pharmacotherapeutic interventions performed by a clinical pharmacist . Evaluation measures included lab values of A1C , LDL cholesterol , BP , and goal attainment of these values , and diabetes self-care behavior question naires at 6 months . Results The r and omization groups were similar at baseline in all cardiovascular risk factors except for LDL , which was significantly lower in the MEDIC-E arm . At 6 months , significant improvements from baseline were found in the intervention arm for exercise , foot care , and goal attainment of A1C , LDL-C , and BP but not in the control arm . Conclusions The results of this study demonstrate that the pharmacist-led group intervention program for 6 months was an efficacious and sustainable collaborative care approach to managing diabetes and reducing associated cardiovascular risk",
"The purpose of this study was : ( 1 ) to record GP opinions , practice s and outcomes for the care of Type 2 Diabetes Mellitus ( DM2 ) , ( 2 ) compare practice facilities and process of care with a criterion of recommended competent care and ( 3 ) determine if there were any differences between vocationally registered and non-vocationally registered GPs . A r and om sample of 204 metropolitan doctors from 124 practice s was selected and an audit performed on 467 of their patient records . GPs pursued good blood sugar control and advocated lifestyle changes before hypoglycaemic drugs . Over 80 % regard uncomplicated DM2 as a condition for general practice management . However , only 15 % conducted an annual diabetes check , 9 % had a diabetic register , 6 % a diabetic recall system and 8 % used a diabetic health care checklist for monitoring their patients . The most commonly recorded processes of medical audit in the previous 12 months were : blood pressure ( 94 % ) , duration of diabetes ( 72 % ) , blood glucose ( 70 % ) , diet ( 66 % ) , body weight ( 56 % ) , HBA1c ( 52 % ) and ophthalmoscopy ( 50 % ) . The least commonly recorded processes of care were body mass index ( 5 % ) , inspection of the feet ( 18 % ) , enquiries about vaginitis or impotence ( 23 % ) . The amount of exercise , alcohol and tobacco was recorded in only 34 % of records . Hypoglycaemic drugs were used appropriately but the most commonly used drugs for treating hypertension in DM2 patients were thiazide diuretics and beta-blockers . Vocationally registered ( VR ) doctors had better records , higher process of care scores and more were willing to participate in the study than non-vocationally registered ( NVR ) doctors . However , there was no difference in metabolic control between patients from either group . The use of a Diabetic Health Care Checklist would improve diabetes care especially in the search for early complications and in the recording of HBA1c and other metabolic parameters . The drugs commonly used to control hypertension can have adverse effects on glucose and lipid metabolism and should be replaced with glucose and lipid neutral drugs",
"Purpose The purpose of this study was to determine whether “ clinical inertia”—inadequate intensification of therapy by the provider — could contribute to high A1C levels in patients with type 2 diabetes managed in a primary care site . Methods In a prospect i ve observational study , management was compared in the Medical Clinic , a primary care site supervised by general internal medicine faculty , and the Diabetes Clinic , a specialty site supervised by endocrinologists . These municipal hospital clinics serve a common population that is largely African American , poor , and uninsured . Results Four hundred thirty-eight African American patients in the Medical Clinic and 2157 in the Diabetes Clinic were similar in average age , diabetes duration , body mass index , and gender , but A1C averaged 8.6 % in the Medical Clinic versus 7.7 % in the Diabetes Clinic ( P Use of pharmacotherapy was less intensive in the Medical Clinic ( less use of insulin ) , and when patients had elevated glucose levels during clinic visits , therapy was less than half as likely to be advanced in the Medical Clinic compared to the Diabetes Clinic ( P Intensification rates were lower in the Medical Clinic regardless of type of therapy ( P intensification of therapy was independently associated with improvement in A1C ( P Medical Clinic patients had worse glycemic control , were less likely to be treated with insulin , and were less likely to have their therapy intensified if glucose levels were elevated . To improve diabetes management and glycemic control nationwide , physicians in training and generalists must learn to overcome clinical inertia , to intensify therapy when appropriate , and to use insulin when clinical ly indicated",
"OBJECTIVE To examine the effect of case management on glycemic control and behavioral outcomes in adults with Type 2 diabetes in China . METHODS Participants were r and omly assigned to a 1-year case management ( CM ) group ( n=60 ) or control group ( n=60 ) . Monthly case management visits included identifying individuals ' diabetes-related problems , setting goals , planning self-care , and evaluating progress . During a 1-year follow-up , all participants attended visits every 3 months without intervention . RESULTS In the CM vs. the control group , HbA1c was reduced at 6 months compared to baseline ( P=0.034 ) , with trends at 12 and 24 months , and empowerment ability improved ( P controls , total self-care behaviors , the frequency of exercise , blood glucose testing , and foot care were higher ( P The case management intervention in China was effective at 6 months and , based on trends in HbA1c at 12 and 24 months and results for behavioral outcomes , the intervention shows promise and warrants more research . PRACTICE IMPLICATION S A case management approach can enhance behavior change and glycemic control in Chinese with diabetes",
"Summary In primary care it is difficult to treat the growing number of non-insulin-dependent diabetic ( NIDDM ) patients according to (inter)national guidelines . A prospect i ve , controlled cohort study was design ed to assess the intermediate term ( 2 years ) effect of structured NIDDM care in general practice with and without ‘ diabetes service ’ support on glycaemic control , cardiovascular risk factors , general well-being and treatment satisfaction . The ‘ diabetes service ’ , supervised by a diabetologist , included a patient registration system , consultation facilities of a dietitian and diabetes nurse educator , and protocol ized blood glucose lowering therapy advice which included home blood glucose monitoring and insulin therapy . In the study group ( SG ; 22 general practice s ) , 350 known NIDDM patients over 40 years of age ( 206 women ; mean age 65.3 ± SD 11.9 ; diabetes duration 5.9 ± 5.4 years ) were followed for 2 years . The control group ( CG ; 6 general practice s ) consisted of 68 patients ( 28 women ; age 64.6 ± 10.3 ; diabetes duration 6.3 ± 6.4 years ) . Mean HbAlc ( reference 4.3 - 6.1 % ) fell from 7.4 to 7.0 % in SG and rose from 7.4 to 7.6 % in CG during follow-up ( p = 0.004 ) . The percentage of patients with poor control ( HbA1c>8.5 % ) shifted from 21.4 to 11.7 % in SG , but from 23.5 to 27.9 % in CG ( p = 0.008 ) . Good control ( HbAlc > 7.0 % ) was achieved in 54.3 % ( SG ; at entry 43.4 % ) and 44.1 % ( CG ; at entry 54.4 % ) ( p = 0.013 ) . Insulin therapy was started in 29.7 % ( SG ) and 8.8 % ( CG ) of the patients ( p = 0.000 ) with low risk of severe hypoglycaemia ( 0.019/patient year ) . Mean levels of total and HDL-cholesterol ( SG ) , triglycerides ( SG ) and diastolic blood pressure ( SG + CG ) and the percentage of smokers ( SG ) declined significantly , but the prevalence of these risk factors remained high . General well-being ( SG ) did not change during intensified therapy . Treatment satisfaction ( SG ) tended to improve . Implementation of structured care , including education and therapeutic advice , results in sustained good glycaemic control in the majority of NIDDM patients in primary care , with low risk of hypoglycaemia . Lowering cardiovascular risk requires more than reporting results and referral to guidelines . [ Diabetologia ( 1997 ) 40 : 1334 -",
"The objective of this study was to evaluate the effect of integrated health management model on the health of older adults with diabetes . The 100 older adults with diabetes who gave informed consent were r and omly allocated 1:1 into management and control groups . The integrated health management model was applied in the former while the latter was only given usual care . This model included the following components : health record establishment , health evaluation and health management ( such as : diet advice , psychological aspects of health , education/skills training on health self-management , regular blood glucose monitoring , long-term diabetes drug monitoring , etc . ) . After 18 months , differences in three categories of variables ( subjective grading items , objective measurement health indices and health service utilization ) between the two groups before and after the intervention were assessed with t-test , χ(2)-test and mixed model analysis . The management group demonstrated improvement on the following variables : health knowledge score , self-evaluated psychological conditions , overall self-evaluated health conditions , diet score , physical activity duration per week , regular blood sugar monitoring , waist-to-hip ratio , diastolic blood pressure and fasting blood sugar , the days of hospital admissions in the preceding 6 months . Mixed model analysis showed that gender , age , self-evaluated health status , self-evaluated psychological status , education level and resident status were important factors affecting health indices . This study demonstrated that integrated health management model was effectiveness in improving the health of older adults with diabetes",
"Control of diabetes mellitus is a high priority for primary health care systems . One innovative method of diabetes care delivery is the use of structured diabetes care in primary care . This includes the use of chronic care diabetes clinics or mini-clinics operated by general practitioners in primary care . There is limited experience with this model in non-Western setting s. This study sought to evaluate a multi-component structured approach to diabetes care in primary care including chronic care diabetes clinics in a newly developed country in the Arabian Gulf . The study design used was a controlled before-after methodology . Three primary health centers were chosen for the intervention with six of the remaining clinics in a Health District being used as controls . A multifaceted intervention was initiated in the intervention clinics composed of chronic care diabetes clinics , a diabetic flow chart , and educational programs for clinic nurses and doctors and patients . The study intervention took place over a period of 18 months with three diabetic outcomes ( fasting blood glucose , blood pressure and cholesterol ) and adherence to seven diabetes guidelines being compared for the year prior to the intervention and during the last 12 months of the intervention period . Knowledge and satisfaction question naires were also administered to intervention and control subjects at the end of the study . In this study , 219 subjects were enrolled ( 130 males and 89 females ) . They had a mean age of 51.6 years and a mean of 3.1 years of formal education . Of these 109 were enrolled in one of three clinics that had a chronic care diabetes clinic and 110 were enrolled in one of the six control clinics . Subjects had diabetes for a mean of 7.8 ± 4.8 years and the majority was treated with pharmacological therapy . Baseline characteristics in the intervention and the control clinics were similar with the exception of younger age ( p = 0.01 ) and a trend for more males ( p = 0.06 ) in the intervention clinics . There was a statistically insignificant change noted with the intervention in the three clinical outcomes studied ( fasting blood glucose , blood pressure and cholesterol ) both in comparison to the control group before and after and within the intervention group . However most changes noted were in the expected direction of improvement ; six of the seven guidelines were statistically improved in the intervention group when compared with the control group . Within the intervention group , adherence with five of seven guidelines was also statistically significantly increased with the remaining guidelines showing a trend in favor of improvement ( fasting blood glucose measurements ( p = 0.07 ) and urine determinations for protein ( p = 0.07 ) ) . Knowledge question naire scores were similar between the intervention and control groups on completion of the study but 2 of 4 items on a satisfaction scale were statistically significantly higher in the intervention group . The intervention described in this setting was successful in improving adherence to diabetes guidelines and increased some aspects of satisfaction with diabetes care . The intervention did not result in a statistically significant improvement in clinical outcomes but changes noted were in the expected direction of improvement . The significant improvement in adherence to diabetes guidelines suggests that this intervention is a promising model for diabetes care for newly developed countries",
"OBJECTIVE To evaluate the effect of adding pharmacists to primary care teams on the management of hypertension and other cardiovascular risk factors in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS We conducted a r and omized controlled trial with blinded ascertainment of outcomes within primary care clinics in Edmonton , Canada . Pharmacists performed medication assessment s and limited history and physical examinations and provided guideline -concordant recommendations to optimize medication management . Follow-up contact was completed as necessary . Control patients received usual care . The primary outcome was a ≥10 % decrease in systolic blood pressure at 1 year . RESULTS A total of 260 patients were enrolled , 57 % were women , the mean age was 59 years , diabetes duration was 6 years , and blood pressure was 129/74 mmHg . Forty-eight of 131 ( 37 % ) intervention patients and 30 of 129 ( 23 % ) control patients achieved the primary outcome ( odds ratio 1.9 [ 95 % CI 1.1–3.3 ] ; P = 0.02 ) . Among 153 patients with inadequately controlled hypertension at baseline , intervention patients ( n = 82 ) were significantly more likely than control patients ( n = 71 ) to achieve the primary outcome ( 41 [ 50 % ] vs. 20 [ 28 % ] ; 2.6 [ 1.3–5.0 ] ; P = 0.007 ) and recommended blood pressure targets ( 44 [ 54 % ] vs. 21 [ 30 % ] ; 2.8 [ 1.4–5.4 ] ; P = 0.003 ) . The 10-year risk of cardiovascular disease , based on changes to the UK Prospect i ve Diabetes Study Risk Engine , were predicted to decrease by 3 % for intervention patients and 1 % for control patients ( P = 0.005 ) . CONCLUSIONS Significantly more patients with type 2 diabetes achieved better blood pressure control when pharmacists were added to primary care teams , which suggests that pharmacists can make important contributions to the primary care of these patients",
"BACKGROUND The objective of this study was to determine whether the management of type 2 diabetes ( DM2 ) can be transferred from an internist to a nurse specialised in diabetes ( NSD ) . METHODS Ninety-three patients with DM2 referred by their general practitioner were r and omised ; 84 patients completed the study . The intervention group received care from an NSD who treated glycaemia , blood pressure and lipid profile by protocol . The control group received care from an internist . The primary endpoint was the main decrease in HbA1c . Secondary endpoints included blood pressure , lipid profile , healthcare costs , QOL , and patient satisfaction . RESULTS HbA1c , total cholesterol , LDL cholesterol and cholesterol/HDL ratio decreased significantly in both study population s after a follow-up time of 12 months . Cholesterol/HDL ratio decreased by 0.4 and 0.9 in the NSD and control group respectively ( p=0.034 for the difference between groups ) . The decreases ( 95 % confidence interval ) in systolic blood pressure were 8.6 mmHg ( 2.6 , 14.7 ) in the NSD group and 4.0 mmHg ( -0.9 , 8.9 ) in the control group , without a significant difference between groups . After one year , 33.3 % of the patients in the NSD group achieved an HbA1c level . Healthcare costs were less and patient satisfaction with the NSD s was significantly better(p QOL . CONCLUSION NSD s using treatment protocol s are able to provide effective care for patients with DM 2 , comparable with the care provided by an internist , with respect to clinical parameters , and superior with respect to healthcare costs and patient satisfaction",
"Objective To test the effectiveness of peer support for patients with type 2 diabetes . Design Cluster r and omised controlled . Setting 20 general practice s in the east of the Republic of Irel and . Participants 395 patients ( 192 in intervention group , 203 in control group ) and 29 peer supporters with type 2 diabetes . Intervention All practice s introduced a st and ardised diabetes care system . The peer support intervention ran over a two year period and contained four elements : the recruitment and training of peer supporters , nine group meetings led by peer supporters in participant ’s own general practice , and a retention plan for the peer supporters . Main outcome measures HbA1c ; cholesterol concentration ; systolic blood pressure ; and wellbeing score . Results There was no difference between intervention and control patients at baseline . All practice s and 85 % ( 337 ) of patients were followed up . At two year follow-up , there were no significant differences in HbA1c ( mean difference −0.08 % , 95 % confidence interval −0.35 % to 0.18 % ) , systolic blood pressure ( −3.9 mm Hg , −8.9 to 1.1 mm Hg ) , total cholesterol concentration ( −0.03 mmol/L , −0.28 to 0.22 mmol/L ) , or wellbeing scores ( −0.7 , −2.3 to 0.8 ) . While there was a trend towards decreases in the proportion of patients with poorly controlled risk factors at follow-up , particularly for systolic blood pressure ( 52 % ( 87/166 ) > 130 mm Hg in intervention v 61 % ( 103/169 ) > 130 mm Hg in control ) , these changes were not significant . The process evaluation indicated that the intervention was generally delivered as intended , though 18 % ( 35 ) of patients in the intervention group never attended any group meetings . Conclusions A group based peer support intervention is feasible in general practice setting s , but the intervention was not effective when targeted at all patients with type 2 diabetes . While there was a trend towards improvements of clinical outcomes , the results do not support the widespread adoption of peer support . Trial registration Current Controlled Trials IS RCT N42541690",
"BACKGROUND The extended roles of pharmacists in Nigeria in the improvement of quality of health care at the primary health care ( PHC ) level is currently poorly executed even though pharmacists have been proven to be involved in interventional activities in health care delivery . OBJECTIVE To evaluate pharmacists ' intervention in the control of blood sugar levels of diabetes patients in a PHC setting in Benin City , Nigeria . METHODS At baseline , the fasting blood sugar ( FBS ) , glycosylated hemoglobin ( HbA1c ) , body mass index ( BMI ) and blood pressure ( BP ) of r and omly selected 170 diabetic patients in a primary health care centre were evaluated . This was followed-up with intervention by the pharmacists through counselling on lifestyle modification , self-medication and drug adherence on monthly basis for three consecutive months after which the FBS , HbA1c , BMI and BP were re-evaluated . RESULTS indicated significant reduction in BMI , HbA1c and FBS from 27.1 + /- 4.2 kg/m2 , 8.1 + /- 3.0 % and 10.0 + /- 4.2 mmol/l to 23.5 + /- 3.5 kg/m2 , 7.1 + /- 1.8 % and 8.5 + /- 2.1 mmol/l , respectively ( p diabetic patients in PHC setting s can significantly improve the quality of life provided to these patients and hence reduce mortality result ing from the disease . Recruitment of reasonable number of pharmacists should always be considered in health policies for PHC setting s in developing countries",
"The increasing prevalence of diabetes and obesity , growing health disparities , and shortage of bilingual and culturally trained health care professionals underscore the role of trained community health workers ( CHWs ) to provide economically sustainable and culturally relevant services . This prospect i ve r and omized design evaluated the relative effectiveness of a CHW intervention among Hispanic persons with newly diagnosed type 2 diabetes , as compared with usual clinic practice in three inner-city health centers . In sum , 189 Hispanic patients newly diagnosed with type 2 diabetes were r and omly assigned to one of three 6-month diabetes management approaches — CHW , case management , and st and ard provider care— and assessed for diabetes-related health measures and clinical indicators at baseline and postintervention . Participants in the CHW group achieved greater improvements than did the controls in program measures : health status , emergency department utilization , dietary habits , physical activity , and medication adherence . They also had 2.9 times greater odds of decreasing body mass index",
"Purpose An initial pilot program demonstrated promising results in improvements in glycosylated hemoglobin ( HbA1c ) , low-density lipoprotein cholesterol ( LDL-C ) , and systolic blood pressure ( SBP ) and prompted us to test these findings in a controlled trial . The purpose of the Diabetes-focused , Algorithm-directed care , Midlevel practitioner – administered , Electronically coached , Treatment ( DAMET-2 ) program clinical trial was to investigate the benefits of a novel program for disseminating guidance in the treatment of diabetes from a central specialist clinic to primary care centers with access to midlevel provider services . Data sources DAMET-2 included st and ardized treatment algorithms and education disseminated through computer-assisted and traditional methods associated with distance medicine . Two primary care practice s were selected and subjects with diagnosed type 2 diabetes ≥6 months , ≥18 years of age with one or more cardiovascular risk factors ( identified by chart review ) were eligible for inclusion . Midlevel practitioners for subjects in the experimental group ( N= 34 ) received training in American Diabetes Association treatment algorithms , had telephone consultations at 2- to 4-week intervals and bimonthly visits with diabetes specialists , and received treatment guidance within 24 h from remote diabetes specialists . Weekly diabetes clinics were made available to subjects in the experimental group . After 12 months , the last available subject data were extracted from the subjects ' charts and compared to 12-month chart data from a control group ( N= 101 ) that did not receive additional study services . Conclusions Mean HbA1c values decreased from baseline by 0.46 % in the active treatment group versus 0.06 % in the control group ; however , reductions in HbA1c did not achieve statistical significance potentially because of the small sample size of the experimental group . Mean SBP values were significantly reduced in both groups ; however , LDL-C was only significantly reduced in the control group , where more aggressive use of statins may have had an effect . Implication s for practice Despite the inconsistencies in risk factor reduction from the pilot program , the DAMET-2 program provided insights regarding the importance of electronic records and provider notifications , patient adherence , prioritization of provider re sources by risk factor level among patients , and access to self-management education",
"Background Health outcomes for Indigenous Australians with diabetes in remote areas remain poor , including high rates of avoidable complications which could be reduced with better primary level care . We aim ed to evaluate the effectiveness of a community-based health-worker led case management approach to the care of Indigenous adults with poorly controlled type 2 diabetes in primary care services in remote northern Australia . Methods Two hundred and thirteen adults with poorly controlled diabetes ( HbA1c > 8.5 % ) and significant comorbidities in 12 remote communities were r and omly assigned by service cluster to receive chronic care co-ordination from a community-based health worker supported by a clinical outreach team , or to a waitlist control group which received usual care . Results At baseline , mean age of participants was 47.9 years , 62.4 % were female , half were Aboriginal and half identified as Torres Strait Isl and er , 67 % had less than 12 years of education , 39 % were smokers , median income was $ 18,200 and 47 % were unemployed . Mean HbA1c was 10.7 % ( 93 mmol/mol ) and BMI 32.5 . At follow-up after 18 months , HbA1c reduction was significantly greater in the intervention group ( −1.0 % vs −0.2 % , SE ( diff ) = 0.2 , p = 0.02 ) . There were no significant differences between the groups for blood pressure , lipid profile , BMI or renal function . Intervention group participants were more likely to receive nutrition and dental services according to scheduled care plans . Smoking rates were unchanged . Conclusions A culturally safe , community level health-worker led model of diabetes care for high risk patients can be effective in improving diabetes control in remote Indigenous Australian communities where there is poor access to mainstream services . This approach can be effective in other remote setting s , but requires longer term evaluation to capture accrued benefits .Trial registration ANZCTR 12610000812099 , Registered 29 September 2010",
"AIMS AND OBJECTIVES To determine whether the management of type 2 diabetes mellitus in a primary care setting can be safely transferred to practice nurses . BACKGROUND Because of the increasing prevalence of type 2 diabetes mellitus and the burden of caring for individual patients , the dem and type 2 diabetes mellitus patients place on primary health care re sources has become overwhelming . DESIGN R and omised controlled trial . METHODS The patients in the intervention group were cared for by practice nurses who treated glucose levels , blood pressure and lipid profile according to a specified protocol . The control group received conventional care from a general practitioner . The primary outcome measure was the mean decrease seen in glycated haemoglobin ( HbA1c ) levels at the end of the follow-up period ( 14 months ) . RESULTS A total of 230 patients was r and omised with 206 completing the study . The between-group differences with respect to reduction in HbA1c , blood pressure and lipid profile were not significant . Blood pressure decreased significantly in both groups ; 7.4/3.2 mm Hg in the intervention group and 5.6/1.0 mm Hg in the control group . In both groups , more patients met the target values goals for lipid profile compared to baseline . In the intervention group , there was some deterioration in the health-related quality of life and an increase in diabetes-related symptoms . Patients being treated by a practice nurse were more satisfied with their treatment than those being treated by a general practitioner . CONCLUSION Practice nurses achieved results , which were comparable to those achieved by a general practitioner with respect to clinical parameters with better patient satisfaction . RELEVANCE TO CLINICAL PRACTICE This study shows that diabetes management in primary care can be safely transferred to practice nurses",
"The aim of this study was to examine whether motivating patients to gain expertise and closely follow their risk parameters will attenuate the course of microvascular and cardiovascular sequelae of diabetes . A r and omized , prospect i ve study was conducted of 165 patients who had type 2 diabetes , hypertension , and hyperlipidemia and were referred for consultation to a diabetes clinic in an academic hospital . Patients were r and omly allocated to st and ard consultation ( SC ) or to a patient participation ( PP ) program . Both groups were followed by their primary care physicians . The mean follow-up was 7.7 yr . The SC group attended eight annual consultations . The PP patients initiated on average one additional consultation per year . There were 80 cardiovascular events ( eight deaths ) in the SC group versus 47 events ( five deaths ) in the PP group ( P = 0.001 ) . The relative risk ( RR ) over 8 yr for a cardiovascular event in the intervention ( PP ) versus the control ( SC ) group was 0.65 ( 95 % confidence interval , 0.89 to 0.41 ) . There were 17 and eight cases of stroke in the SC and PP groups , respectively ( P = 0.05 ) . RR for stroke was 0.47 ( 95 % confidence interval , 0.85 to 0.32 ) . In the SC group , 14 patients developed overt nephropathy ( four ESRD ) versus seven ( one ESRD ) in the PP group ( P = 0.05 ) . Throughout the study period , BP , LDL cholesterol , and hemoglobin A1c were significantly lower in the PP than in the SC patients . Well informed and motivated patients were more successful in obtaining and maintaining good control of their risk factors , result ing in reduced cardiovascular risk and slower progression of microvascular disease",
"AIMS To evaluate patient outcomes for a novel integrated primary /specialist model of community care for complex Type 2 diabetes mellitus management compared with outcomes for usual care at a tertiary hospital for diabetes out patients . METHODS This was a prospect i ve open controlled trial performed in a primary and tertiary care setting in Australia . A total of 330 patients with Type 2 diabetes aged > 18 years were allocated to an intervention ( n=185 ) or usual care group ( n=145 ) . The intervention arm was a community-based model of care led by a general practitioner with advanced skills and an endocrinologist partnership . Usual care was provided via the hospital diabetes outpatient department . The primary end point was HbA(1c ) concentration at 12 months . Secondary end points included serum lipids and blood pressure . RESULTS The mean change in HbA1c concentration in the intervention group was -9 mmol/mol ( -0.8 % ) at 12 months and in the usual care group it was -2 mmol/mol ( -0.2 % ) ( 95 % CI -5,1 ) . The percentage of patients in the intervention group achieving the HbA(1c ) target of ≤53 mmol/mol ( 7 % ) increased from 21 to 42 % ( P significant improvements in blood pressure and total cholesterol compared with those in the usual care group . The percentage of patients achieving clinical targets was greater in the intervention group for the combined target of HbA(1c ) concentration , blood pressure and LDL cholesterol . CONCLUSIONS A community-based , integrated model of complex diabetes care , delivered by general practitioners with advanced skills , produced clinical and process benefits compared with a tertiary diabetes outpatient clinic",
"Objective To evaluate the effectiveness of a structured group education programme on biomedical , psychosocial , and lifestyle measures in people with newly diagnosed type 2 diabetes . Design Multicentre cluster r and omised controlled trial in primary care with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 824 adults ( 55 % men , mean age 59.5 years ) . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures Haemoglobin A1c levels , blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , and emotional impact of diabetes at baseline and up to 12 months . Main results Haemoglobin A1c levels at 12 months had decreased by 1.49 % in the intervention group compared with 1.21 % in the control group . After adjusting for baseline and cluster , the difference was not significant : 0.05 % ( 95 % confidence interval −0.10 % to 0.20 % ) . The intervention group showed a greater weight loss : −2.98 kg ( 95 % confidence interval −3.54 to −2.41 ) compared with 1.86 kg ( −2.44 to −1.28 ) , P=0.027 at 12 months . The odds of not smoking were 3.56 ( 95 % confidence interval 1.11 to 11.45 ) , P=0.033 higher in the intervention group at 12 months . The intervention group showed significantly greater changes in illness belief scores ( P=0.001 ) ; directions of change were positive indicating greater underst and ing of diabetes . The intervention group had a lower depression score at 12 months : mean difference was −0.50 ( 95 % confidence interval −0.96 to −0.04 ) ; P=0.032 . A positive association was found between change in perceived personal responsibility and weight loss at 12 months ( β=0.12 ; P=0.008 ) . Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes result ed in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A1c levels up to 12 months after diagnosis . Trial registration Current Controlled Trials IS RCT N17844016",
"ABSTRACT Background Several trials have demonstrated the efficacy of nurse telephone case management for diabetes ( DM ) and hypertension ( HTN ) in academic or vertically integrated systems . Little is known about the real-world potency of these interventions . Objective To assess the effectiveness of nurse behavioral management of DM and HTN in community practice s among patients with both diseases . Design The study was design ed as a patient-level r and omized controlled trial . Participants Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practice s. Subjects were required to have inadequately controlled DM ( hemoglobin A1c [ A1c ] ≥ 7.5 % ) but could have well-controlled HTN . Interventions All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years , for a total of 12 calls . Intervention patients received tailored DM- and HTN- focused behavioral content ; control patients received non-tailored , non-interactive information regarding health issues unrelated to DM and HTN ( e.g. , skin cancer prevention).Main Outcomes and Measures Systolic blood pressure ( SBP ) and A1c were co- primary outcomes , measured at 6 , 12 , and 24 months ; 24 months was the primary time point . Results Three hundred seventy-seven subjects were enrolled ; 193 were r and omized to intervention , 184 to control . Subjects were 55 % female and 50 % white ; the mean baseline A1c was 9.1 % ( SD = 1 % ) and mean SBP was 142 mmHg ( SD = 20 ) . Eighty-two percent of scheduled interviews were conducted ; 69 % of intervention patients and 70 % of control patients reached the 24-month time point . Expressing model estimated differences as ( intervention – control ) , at 24 months , intervention patients had similar A1c [ diff = 0.1 % , 95 % CI ( −0.3 , 0.5 ) , p = 0.51 ] and SBP [ diff = −0.9 mmH g , 95 % CI ( −5.4 , 3.5 ) , p = 0.68 ] values compared to control patients . Likewise , DBP ( diff = 0.4 mmHg , p = 0.76 ) , weight ( diff = 0.3 kg , p = 0.80 ) , and physical activity levels ( diff = 153 MET-min/week , p = 0.41 ) were similar between control and intervention patients . Results were also similar at the 6- and 12-month time points . Conclusions In nine community fee-for-service practice s , telephonic nurse case management did not lead to improvement in A1c or SBP . Gains seen in telephonic behavioral self-management interventions in optimal setting s may not translate to the wider range of primary care setting",
"Objective To assess the effectiveness of a coach-led motivational interviewing ( MI ) intervention in improving glycaemic control , as well as clinical , psychosocial and self-care outcomes of individuals with type 2 diabetes mellitus ( T2DM ) compared with usual care . Design Pragmatic cluster r and omised controlled trial ( RCT ) . Setting Community Health Stations ( CHSs ) in Fengtai district , Beijing , China . Participants Of the 41 r and omised CHSs ( 21 intervention and 20 control ) , 21 intervention CHSs ( 372 participants ) and 18 control CHSs ( 296 participants ) started participation . Intervention Intervention participants received telephone and face-to-face MI health coaching in addition to usual care from their CHS . Control participants received usual care only . Medical fees were waived for both groups . Outcome measures Outcomes were assessed at baseline , 6 and 12 months . Primary outcome measure was glycated haemoglobin ( HbA1c ) . Secondary outcomes included a suite of anthropometric , blood pressure ( BP ) , fasting blood , psychosocial and self-care measures . Results At 12 months , no differential treatment effect was found for HbA1c ( adjusted difference 0.02 , 95 % CI −0.40 to 0.44 , p=0.929 ) , with both treatment and control groups showing significant improvements . However , two secondary outcomes : psychological distress ( adjusted difference −2.38 , 95 % CI −4.64 to −0.12 , p=0.039 ) and systolic BP ( adjusted difference −3.57 , 95 % CI −6.08 to −1.05 , p=0.005 ) were robust outcomes consistent with significant differential treatment effects , as supported in sensitivity analyses . Interestingly , in addition to HbA1c , both groups displayed significant improvements in triglycerides , LDL cholesterol and HDL cholesterol . Conclusions In line with the current Chinese primary healthcare reform , this study is the first large-scale cluster RCT to be implemented within real-world CHSs in China , specifically addressing T2DM . Although a differential treatment effect was not observed for HbA1c , numerous outcomes ( including HbA1c ) improved in both groups , supporting the establishment of regular , free clinical health checks for people with T2DM in China . Trial registration number IS RCT N01010526 ; Pre- results",
"BACKGROUND This study was done to determine the efficacy and ease of administration of education/behavior modification classes , provided by a nurse and a dietitian in a primary care clinic for improving control of type 2 diabetes mellitus . METHODS Patients were divided r and omly into two groups . Eighteen patients completed 6 months of structured , office-based classes , and 20 similar patients served as control subjects . All were patients of the same group practice and had their usual office visits . Glycemic control , lipid levels , body weight , knowledge about diabetes , medication requirements , and symptoms were monitored during the 6 months , with follow-up at 12 months . RESULTS At the end of 6 months , the intervention group had significant reductions in mean fasting blood glucose , glycosylated hemoglobin , total cholesterol , and low-density lipoprotein cholesterol ( LDL-C ) values . Their mean body weight was significantly reduced at 12 months , and their knowledge of diabetes was improved . Control patients had significant improvement only in glycosylated hemoglobin and body weight at 6 months . Minimal physician time was required . CONCLUSION The education/behavior modification program was clinical ly worthwhile , and it was easy to administer",
"BACKGROUND : There is limited information from r and omized controlled studies about the influence of pharmacist interventions on diabetes control . OBJECTIVE : To evaluate the effect of a pharmacist intervention on improving diabetes control ; secondary endpoints were medication appropriateness and self-reported adherence . METHODS : A r and omized , controlled , multi-clinic trial was conducted in the University of Washington Medicine Neighborhood Clinics . Seventy-seven subjects , ⩾18 years old with a hemoglobin ( Hb ) A1c ⩾9 % at baseline and taking at least one oral diabetes medication , were r and omized to receive a pharmacist intervention ( n = 43 ) or usual care ( n = 34 ) for 6 months followed by a 6-month usual-care observation period for both groups . Subjects met with a clinical pharmacist to establish and initiate a diabetes care plan followed by weekly visits or telephone calls to facilitate diabetes management and adherence . HbA1c , medication appropriateness , and self-reported adherence were assessed at baseline , 6 months , and 12 months . RESULTS : The mean HbA1c did not differ between groups over the 12-month period ( p = 0.61 ) . A reduction in HbA1c was noted for both groups over time compared with baseline ( p = 0.001 ) ; however , control subjects relied more heavily on provider visits . Medication appropriateness was not improved for diabetes medications ( p = 0.65 ) . Self-reported adherence was not significantly improved by the intervention . CONCLUSIONS : This pharmacist intervention did not significantly improve diabetes control , but did allow for similar HbA1c control with fewer physician visits . Medication appropriateness and self-reported adherence compared with usual care in individuals with poorly controlled diabetes were not changed",
"BACKGROUND This study investigated the status of diabetes control and management in patients treated in a primary healthcare setting and compared the results with data previously obtained for secondary /tertiary care patients in Taiwan . METHODS This study was conducted at 51 primary healthcare stations r and omly selected isl and -wide in Taiwan in 2001 . A total of 1302 type 2 diabetes patients who had been followed-up for more than 1 year were included . Blood was collected for central ized HbA1c assay . The remaining data and information were collected by review of medical records and patient interview . RESULTS Compared with the results of a previous study on patients treated in a secondary /tertiary care setting , a significantly smaller percentage of primary care patients were receiving insulin therapy . Primary care patients also had a shorter duration of diabetes , a higher HbA1c level , better blood pressure control and a lower prevalence of complications . The proportion of patients achieving optimal control of glycemia and blood pressure was low . Patients aged had a significantly shorter duration of diabetes , poorer diabetes control and better blood pressure control than elderly patients aged > or = 65 years . Primary care patients aged > or = 65 years had a significantly higher frequency of stroke than those aged elderly group of secondary /tertiary care patients had a significantly higher frequency of coronary heart disease and stroke . Duration of diabetes and hypertension were the leading risk factors for complications in diabetes patients treated in both primary and secondary /tertiary care setting s. CONCLUSION Diabetes control was poorer in primary care than in secondary /tertiary care patients , but control of blood pressure was better in primary care patients . The shorter duration of diabetes and better control of blood pressure in primary care patients and in patients aged < 65 years compared with their elderly counterparts might be related to a lower prevalence of complications",
"AIMS /HYPOTHESIS JEVIN ( Jena 's St. Vincent Trial ) is a prospect i ve , 10 year follow-up , population -based survey of all insulin treated patients with type 1 and type 2 diabetes mellitus aged 16 to 60 years and living in the city of Jena ( 100,000 inhabitants ) , Thuringia , Germany . It aims to show the effects of implementation of the St. Vincent Declaration and to evaluate the effect of recent changes in the health care system and new treatment strategies . PATIENTS AND METHODS 190 patients ( 83 % of the target population ) , 244 patients ( 90 % ) and 261 patients ( 90 % ) were studied in 1989/90 , 1994/95 and 1999/2000 , respectively . RESULTS Up to 1994/95 , the HbA1c of patients with type 1 diabetes mellitus increased ( 1994/95 : 8.50+/-1.80 % versus 1989/90 : 7.83+/-1.60 % , p=0.002 ) . For patients with type 2 diabetes mellitus , it remained constant ( 9.01+/-2.06 % versus 9.17+/-1.60 % , n. s. ) . During the period from 1994/95 to 1999/2000 , there was a substantial improvement in the relative HbA1c of both , patients with type 1 ( 7.62+/-1.55 % , p incidence of acute and the prevalence of long-term complications remained constant . CONCLUSIONS Results of the population -based , prospect i ve trial to optimise patients ' quality of diabetic control suggest : For patients with insulin treated type 2 diabetes mellitus , excellent treatment can be available by primary care physicians interested , educated and highly engaged in diabetes therapy . Moreover , structured diabetes therapy consisting of treatment and teaching programmes , regular self-monitoring , patients ' insulin dose adjustment and patients ' empowerment , should be offered to all patients with diabetes mellitus",
"BACKGROUND Re source barriers complicate diabetes care management . Support from peers may help patients manage their diabetes . OBJECTIVE To compare a reciprocal peer-support ( RPS ) program with nurse care management ( NCM ) . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00320112 ) SETTING 2 U.S. Department of Veterans Affairs health care facilities . PATIENTS 244 men with hemoglobin A(1c ) ( HbA(1c ) ) levels greater than 7.5 % during the previous 6 months . MEASUREMENTS The primary outcome was 6-month change in HbA(1c ) level . Secondary outcomes were changes in insulin therapy ; blood pressure ; and patient reports of medication adherence , diabetes-related support , and emotional distress . INTERVENTION Patients in the RPS group attended an initial group session to set diabetes-related behavioral goals , receive peer communication skills training , and be paired with another age-matched peer patient . Peers were encouraged to talk weekly using a telephone platform that recorded call occurrence and provided reminders to promote peer contact . These patients could also participate in optional group sessions at 1 , 3 , and 6 months . Patients in the NCM group attended a 1.5-hour educational session and were assigned to a nurse care manager . RESULTS Of the 244 patients enrolled , 216 ( 89 % ) completed the HbA(1c ) assessment s and 231 ( 95 % ) completed the survey assessment s at 6 months . Mean HbA(1c ) level decreased from 8.02 % to 7.73 % ( change , -0.29 % ) in the RPS group and increased from 7.93 % to 8.22 % ( change , 0.29 % ) in the NCM group . The difference in HbA(1c ) change between groups was 0.58 % ( P = 0.004 ) . Among patients with a baseline HbA(1c ) level greater than 8.0 % , those in the RPS group had a mean decrease of 0.88 % , compared with a 0.07 % decrease among those in the NCM group ( between-group difference , 0.81 % ; P insulin therapy , compared with 1 patient in the NCM group ( P = 0.020 ) . Groups did not differ in blood pressure , self-reported medication adherence , or diabetes-specific distress , but the RPS group reported improvement in diabetes social support . LIMITATION The study included only male veterans and lasted only 6 months . CONCLUSION Reciprocal peer support holds promise as a method for diabetes care management",
"AIM To assess the effectiveness of the Diabetes Project in Davao City , Philippines , regarding diabetes care access , diabetes management and cardiovascular risk factors . The project was developed in accordance with the Chronic Care Model ( CCM ) framework . METHODS A non-r and omized cross-sectional survey was conducted in nine intervention and five control Barangays ( villages ) . People with diabetes aged ≥20 years were interviewed using a structured question naire ; height , weight , waist circumference , and blood pressure were measured ; HbA1c was tested with a NSGP-certified point-of-care device . Logistic regression models were used to compare the two groups . RESULTS The intervention group ( n=503 ) scored better than the controls ( n=136 ) on the following ( OR , 95 % CI ) : percentage of patients taking metformin ( 1.5 , 1.0 - 2.2 ) ; and in the last 12 months : laboratory test for fasting blood sugar ( 1.6 , 1.1 - 2.3 ) , HbA1c ( 6.0 , 2.4 - 15.1 ) , lipid profile ( 1.7 , 1.1 - 2.5 ) , nutritionist visit ( 1.6 , 1.0 - 2.5 ) and therapeutic education session ( 2.7 , 1.8 - 4.0 ) . Glycemic control ( HbA1c for number of visits , and levels of other cardiovascular risk factors . CONCLUSIONS Our findings support the effectiveness of implementing the CCM framework in a low-to-middle income country on glycemic control and diabetes management ",
"OBJECTIVES To demonstrate that pharmacists working with physicians and other providers in an ambulatory care setting can improve glucose , blood pressure , and lipid control for patients with type 2 diabetes and to report patient adherence to screening and general preventive measures . DESIGN Prospect i ve , r and omized , clinical practice study . SETTING Burlington , MA , between January 2001 and August 2003 . PATIENTS 164 patients patients with type 2 diabetes older than 18 years with glycosylated hemoglobin ( A1C ) greater than 8 % . INTERVENTION Pharmacist-patient clinic visits included obtaining a comprehensive medication review ; performing targeted physical assessment ; ordering laboratory tests ; review ing , modifying , and monitoring patients ' medication therapy and providing detailed counseling on all therapies ; facilitating self-monitoring of blood glucose ; and providing reinforcement of dietary guidelines and exercise . MAIN OUTCOME MEASURE Effect of clinical pharmacists working with physicians in an ambulatory setting on health measures ( e.g. , A1C , blood pressure , cholesterol ) of patients with diabetes . RESULTS Baseline characteristics were similar between the two groups . After 1 year , significant improvements occurred for A1C and low-density lipoprotein ( LDL ) cholesterol in the intervention group compared with the control group ( A1C , 7.7 % vs. 8.4 % ; LDL , 93.7 vs. 105.1 mg/dL ; P Systolic blood pressure improved for all study patients without a difference between the two groups . Diastolic blood pressure improved significantly in the intervention group compared with the control group ( 73.4 mm Hg vs. 77.6 mm Hg , P retinopathy , neuropathy , and microalbuminuria than control patients ( P < 0.05 ) . CONCLUSION For all indices measured , this study demonstrated that collaborative diabetes management with a clinical pharmacist can improve overall care",
"OBJECTIVE To study differences in diabetes-related parameters in type 2 diabetic patients treated with the support of a Diabetes Service compared to conventional general practice care . DESIGN Parallel clinical trial with r and omisation at practice level . SETTING Fifteen general practice s. PATIENTS Type 2 diabetic patients , aged MAIN OUTCOME MEASURES Level of glycated haemoglobin ( HbA1c ) . RESULTS 246 patients entered the study . Final mean HbA1c of all evaluable patients allocated to the intervention ( n = 84 ) was 7.1+/-1.2 % , vs 7.5+/-1.8 % in the controls ( n = 140 ) ( p = 0.06 ) . Patients who were initially poorly controlled ( Fasting Blood Glucose > 10 mmol/l ) had a significantly lower final HbA1c if they were in an intervention practice ( p=0.001 ) . Fewer patients in intervention practice s were referred to hospital specialists ( 1 vs 14 ) . CONCLUSIONS Support by the Dutch Diabetes Service did not significantly influence glycated haemoglobin . The subgroup of initially poorly controlled patients developed a significantly lower HbA1c in intervention practice s ( supported by a Diabetes Service ) than in control practice ",
"BACKGROUND Cardiovascular disease is the main cause of morbidity and mortality in patients with type 2 diabetes mellitus ( DM ) . Intervention on cardiovascular risk factors ( CVRF ) is essential to obtain clinical results reducing the excess of cardiovascular risk ( CVR ) in these patients . METHODS The objective of this study was to describe the association of type 2 DM with modifiable cardiovascular risk factors and the degree of control of these in a population of type 2 diabetics in attendance in primary care clinics , and also to establish prospect ively whether an integral and multifactorial intervention on uncontrolled cardiovascular risk factors , carried out in conditions of routine clinical practice by applying an open protocol , could significantly reduce the estimated CVR according to the Framingham scale . The proposed intervention included both actions aim ed at modifying habits , and pharmacologic intervention to achieve an optimum level of control in accordance with international recommendations for the objectives and treatment for type 2 diabetes . RESULTS A total of 3466 patients with a mean age of 58 + /- 7.5 years were studied and followed-up for 1 year . Of these , 90.4 % of patients had high blood pressure ; 60.1 % of men and 32.7 % of women presented CVR > 20 % in 10 years according to the Framingham scale by categories . Intervention at 1 year of follow-up had achieved statistically significant reductions in blood pressure , glycated hemoglobin , and lipid levels , but not of patients ' body weight . After 1 year of follow-up , 29 % of males and 24 % of women with a high CVR ( > 20 % ) at the start of the study presented reduced risk levels . CONCLUSION The results of the study demonstrate that an integrated and multifactorial intervention in type 2 diabetic patients can achieve clinical ly significant reductions in CVR . However , conducted in effective conditions , it is not able to achieve optimum levels of control in spite of the initial proposal , possibly due to some degree of inertia in routine clinical practice",
"OBJECTIVE : To determine the impact of clinical pharmacists involved in direct patient care on the glycemic control of patients with type 2 diabetes mellitus . DESIGN : Eligible patients included those with type 2 diabetes who received insulin or were initiated on insulin therapy by the pharmacists and were willing to perform self-monitoring of blood glucose . The pharmacists provided diabetes education , medication counseling , monitoring , and insulin initiation and /or adjustments . All initial patient interactions with the pharmacists were face-to-face . Thereafter , patient – pharmacist interactions were either face-to-face or telephone contacts . SETTING : Two primary care clinics in a university-affiliated Veterans Affairs Medical Center . PARTICIPANTS : Study subjects were patients with type 2 diabetes who were referred to the pharmacists by their primary care providers for better glycemic control . OUTCOME MEASURES : Primary outcome variables were changes from baseline in glycosylated hemoglobin , fasting blood glucose , and r and om blood glucose measurements . Secondary outcomes were the number and severity of symptomatic episodes of hypoglycemia , and the number of emergency room visits or hospitalizations related to diabetes . Twenty-three veterans aged 65 ± 9.4 years completed the study . Fifteen ( 65 % ) patients were initiated on insulin by the pharmacists ; 8 ( 35 % ) were already using insulin . Patients were followed for a mean ± SD of 27 ± 10 weeks . Glycosylated hemoglobin , fasting blood glucose concentrations , and r and om blood glucose concentrations significantly decreased from baseline by 2.2 % ( p = 0.00004 ) , 65 mg/dL ( p respectively . Symptomatic hypoglycemic episodes occurred in 35 % of patients . None of these episodes required physician intervention . CONCLUSIONS : This study demonstrates that pharmacists working as members of interdisciplinary primary care teams can positively impact glycemic control in patients with type 2 diabetes requiring insulin",
"Background : Public insurance for testing supplies for self-monitoring of blood glucose is highly variable across Canada . We sought to determine if insured patients were more likely than uninsured patients to use self-monitoring and whether they had better glycemic control . Methods : We used baseline survey and laboratory data from patients enrolled in a r and omized controlled trial examining the effect of paying for testing supplies on glycemic control . We recruited patients through community pharmacies in Alberta and Saskatchewan from Nov. 2001 to June 2003 . To avoid concerns regarding differences in provincial coverage of self-monitoring and medications , we report the analysis of Alberta patients only . Results : Among our sample of 405 patients , 41 % had private or public insurance coverage for self-monitoring testing supplies . Patients with insurance had significantly lower hemoglobin A1c concentrations than those without insurance coverage ( 7.1 % v. 7.4 % , p = 0.03 ) . Patients with insurance were younger , had a higher income , were less likely to have a high school education and were less likely to be married or living with a partner . In multivariate analyses that controlled for these and other potential confounders , lack of insurance coverage for self-monitoring testing supplies was still significantly associated with higher hemoglobin A1c concentrations ( adjusted difference 0.5 % , p = 0.006 ) . Interpretation : Patients without insurance for self-monitoring test strips had poorer glycemic control",
"Purpose The purpose of this study was to assess whether providing medication adherence information with or without motivational interviewing improves diabetes and lipid control . Methods Study participants were adult members of a health system in southeast Michigan , were using both oral diabetes and lipid-lowering medications , and had glycated hemoglobin ( A1C ) or low-density lipoprotein cholesterol ( LDL-C ) levels not at goal . Participants were r and omly assigned to receive usual care ( UC ) , n = 567 ; have medication adherence information ( AI ) provided to their physician , n = 569 ; or have AI and receive motivational interviewing ( MI ) though trained staff ( AI + MI ) , n = 556 . Primary outcomes were A1C and LDL-C levels at 18 months post r and omization . Results Primary outcomes were not significantly different between patients in the AI or AI + MI study arms when compared with UC . Similarly , neither oral diabetes nor lipid-lowering medication adherence was significantly different between groups . Patient participation in the AI + MI arm was low and limit the interpretation of the study results , but post hoc analysis of the AI + MI study arm showed that the number of MI sessions received was positively associated with only oral diabetes medication adherence . Conclusion Neither AI nor MI significantly improved diabetes and lipid control when compared with UC . Moreover , patient participation appeared to be a particular barrier for MI",
"Value-based insurance design ( VBID ) initiatives have been associated with modest improvements in adherence based on evaluations of administrative cl aims data . The objective of this prospect i ve cohort study was to report the patient-centered outcomes of a VBID program that eliminated co-payments for diabetes-related medications and supplies for employees and dependents with diabetes at a large health system . The authors compared self-reported values of medication adherence , cost-related nonadherence , health status , and out-of-pocket health care costs for patients before and 1 year after program implementation . Clinical metrics and satisfaction with the program also are reported . In all , 188 patients completed the follow-up evaluation . Overall , patients reported a significant reduction in monthly out-of-pocket costs ( P cost-related nonadherence from 41 % to 17.5 % ( P Self-reported medication adherence increased for hyperglycemic medications ( P=0.011 ) , but there were no apparent changes in glycemic control . Overall , 89 % of participants agreed that the program helped them take better care of their diabetes . The authors found that a VBID program for employees and dependents with diabetes was associated with self-reported reductions in cost-related nonadherence and improvements in medication adherence . Importantly , the program was associated with high levels of satisfaction among participants and strongly perceived by participants to facilitate medication utilization and self-management for diabetes . These findings suggest that VBID programs can accomplish the anticipated goals for medication utilization and are highly regarded by participants . Patient-centered outcomes should be included in VBID evaluations to allow decision makers to determine the true impact of VBID programs on participants"
] | 41163a80-06ff-11f0-808a-c43d1ab1c353 |
OBJECTIVE The aim of this study was to review the current corpus of human studies to determine the association of various doses and duration s of fructose consumption on metabolic syndrome . METHODS We search ed human studies in PubMed , Scopus , Ovid , ISI Web of Science , Cochrane library , and Google Scholar data bases . We search ed for the following keywords in each paper : metabolic syndrome x , insulin resistance , blood glucose , blood sugar , fasting blood sugar , triglycerides , lipoproteins , HDL , cholesterol , LDL , blood pressure , mean arterial pressure , systolic blood pressure , diastolic blood pressure , hypertens * , waist circumference , and fructose , sucrose , high-fructose corn syrup , or sugar . RESULTS Overall , 3102 articles were gathered . We excluded studies on natural fructose content of foods , non- clinical trials , and trials in which fructose was recommended exclusively as sucrose or high-fructose corn syrup . Overall , 3069 articles were excluded . After review by independent review ers , 15 studies were included in the meta- analysis . Fructose consumption was positively associated with increased fasting blood sugar ( FBS ; summary mean difference , 0.307 ; 95 % confidence interval [ CI ] , 0.149 - 0.465 ; P = 0.002 ) , elevated triglycerides ( TG ; 0.275 ; 95 % CI , 0.014 - 0.408 ; P = 0.002 ) ; and elevated systolic blood pressure ( SBP ; 0.297 ; 95 % CI , 0.144 - 0.451 ; P = 0.002 ) . The corresponding figure was inverse for high-density lipoprotein ( HDL ) cholesterol ( -0.267 ; 95 % CI , -0.406 to -0.128 ; P = 0.001 ) . Significant heterogeneity existed between studies , except for FBS . After excluding studies that led to the highest effect on the heterogeneity test , the association between fructose consumption and TG , SBP , and HDL became non-significant . The results did not show any evidence of publication bias . No missing studies were identified with the trim- and -fill method . CONCLUSION Fructose consumption from industrialized foods has significant effects on most components of metabolic syndrome | [
"We have studied whether the sucrose-induced reduction of insulin sensitivity and cellular insulin binding in normal man is related to the fructose or the glucose moiety . Seven young healthy subjects were fed their usual diets plus 1000 kcal extra glucose per day and eight young healthy subjects were fed their usual diets with addition of 1000 kcal extra fructose per day . The dietary regimens continued for 1 week . Before change of diet there were no statistically significant differences between body weight and fasting plasma concentrations of glucose , insulin , and ketone bodies in the two groups studied . High-glucose feeding caused no significant changes in insulin binding or insulin sensitivity whereas high-fructose feeding was accompanied by a significant reduction both of insulin binding ( P less than 0.05 ) and insulin sensitivity ( P less than 0.05 ) . The changes in insulin binding and insulin sensitivity correlated linearly ( r = 0.52 , P less than 0.01 ) . We conclude that fructose seems to be responsible for the impaired insulin binding and insulin sensitivity induced by sucrose",
" Twelve carbohydrate-sensitive men selected due to their abnormally high insulin responses to a sucrose load and 12 men with normal insulin responses were fed diets containing 0 , 7.5 , and 15 % fructose for 5 wk each in a cross-over design . The diets contained 43 % total carbohydrate , 42 % fat , and 15 % protein . Initial fasting total cholesterol and low-density lipoprotein cholesterol were higher in the hyperinsulinemic men than in the controls . Diastolic blood pressure was not affected by diet , but systolic blood pressure was slightly higher after the men consumed the 0 % fructose diet . Free fatty acids were not different . Total plasma cholesterol and low-density lipoprotein cholesterol were higher after the men consumed 7.5 and 15 % fructose than when they consumed the 0 % fructose diet . Plasma triglyceride increased significantly as fructose in the diets of the hyperinsulinemics increased , but was not affected in the controls . These changes in blood lipids are associated with heart disease",
"BACKGROUND About 9 % of average dietary energy intake in the United States comes from fructose . Such a high consumption raises concern about the metabolic effects of this sugar . OBJECTIVE The objective of this study was to determine the effect of dietary fructose on plasma lipids . DESIGN The study was conducted in the General Clinical Research Center at Fairview-University of Minnesota Medical Center . The participants were 24 healthy adult volunteers ( 12 men and 12 women ; 6 of each sex were aged /=40 y ) . All subjects received 2 isoenergetic study diets assigned by using a r and omized , balanced crossover design . One diet provided 17 % of energy as fructose . The other diet was sweetened with glucose and was nearly devoid of fructose . Each diet was fed for 6 wk . Both diets were composed of common foods and contained nearly identical amounts of carbohydrate , protein , fat , fiber , cholesterol , and saturated , monounsaturated , and polyunsaturated fatty acids . All meals were prepared in the metabolic kitchen of the General Clinical Research Center . RESULTS The responses to the study diets differed by sex . In men , the fructose diet produced significantly higher fasting , postpr and ial , and daylong plasma triacylglycerol concentrations than did the glucose diet . The daylong plasma triacylglycerol concentration after 6 wk of the fructose diet was 32 % greater in men than the corresponding concentration during the glucose diet ( P : fructose diet had no significant effect on fasting or postpr and ial plasma triacylglycerol concentrations in women . The fructose diet also had no persistent effect on fasting plasma cholesterol , HDL cholesterol , or LDL cholesterol in either men or women . CONCLUSIONS Dietary fructose was associated with increased fasting and postpr and ial plasma triacylglycerol concentrations in men . Diets high in added fructose may be undesirable , particularly for men . Glucose may be a suitable replacement sugar",
"Background / Objectives : The results of short-term studies in humans suggest that , compared with glucose , acute consumption of fructose leads to increased postpr and ial energy expenditure and carbohydrate oxidation and decreased postpr and ial fat oxidation . The objective of this study was to determine the potential effects of increased fructose consumption compared with isocaloric glucose consumption on substrate utilization and energy expenditure following sustained consumption and under energy-balanced conditions . Subjects/ Methods : As part of a parallel arm study , overweight/obese male and female subjects , 40–72 years , consumed glucose- or fructose-sweetened beverages providing 25 % of energy requirements for 10 weeks . Energy expenditure and substrate utilization were assessed using indirect calorimetry at baseline and during the 10th week of intervention . Results : Consumption of fructose , but not glucose , led to significant decreases of net postpr and ial fat oxidation and significant increases of net postpr and ial carbohydrate oxidation ( P . Resting energy expenditure ( REE ) decreased significantly from baseline values in subjects consuming fructose ( P=0.031 ) but not in those consuming glucose . Conclusions : Increased consumption of fructose for 10 weeks leads to marked changes of postpr and ial substrate utilization including a significant reduction of net fat oxidation . In addition , we report that REE is reduced compared with baseline values in subjects consuming fructose-sweetened beverages for 10 weeks",
"OBJECTIVE In normal adults , a small ( catalytic ) dose of fructose administered with glucose decreases the glycemic response to a glucose load , especially in those with the poorest glucose tolerance . We hypothesized that an acute catalytic dose of fructose would also improve glucose tolerance in individuals with type 2 diabetes . RESEARCH DESIGN AND METHODS Five adults with type 2 diabetes underwent an oral glucose tolerance test ( OGTT ) on two separate occasions , at least 1 week apart . Each OGTT consisted of 75 g glucose with or without the addition of 7.5 g fructose ( OGTT + F or OGTT - F ) , in r and om order . Arterialized blood sample s were collected from a heated dorsal h and vein twice before ingestion of the carbohydrate and every 15 min for 3 h afterward . RESULTS The area under the curve ( AUC ) of the plasma glucose response was reduced by fructose administration in all subjects ; the mean AUC during the OGTT + F was 14 % less than that during the OGTT - F ( P insulin AUC was decreased 21 % with fructose administration ( P = 0.2 ) . Plasma glucagon concentrations declined similarly during OGTT - F and OGTT + F. The incremental AUC of the blood lactate response during the OGTT - F was approximately 50 % of that observed during the OGTT + F ( P nonesterified fatty acid nor triglyceride concentrations differed between the two OGTTs . CONCLUSIONS Low-dose fructose improves the glycemic response to an oral glucose load in adults with type 2 diabetes , and this effect is not a result of stimulation of insulin secretion",
"Previous studies indicate that leptin secretion is regulated by insulin-mediated glucose metabolism . Because fructose , unlike glucose , does not stimulate insulin secretion , we hypothesized that meals high in fructose would result in lower leptin concentrations than meals containing the same amount of glucose . Blood sample s were collected every 30 - 60 min for 24 h from 12 normal-weight women on 2 r and omized days during which the subjects consumed three meals containing 55 , 30 , and 15 % of total kilocalories as carbohydrate , fat , and protein , respectively , with 30 % of kilocalories as either a fructose-sweetened [ high fructose ( HFr ) ] or glucose-sweetened [ high glucose ( HGl ) ] beverage . Meals were isocaloric in the two treatments . Postpr and ial glycemic excursions were reduced by 66 + /- 12 % , and insulin responses were 65 + /- 5 % lower ( both P area under the curve for leptin during the first 12 h ( -33 + /- 7 % ; P diurnal amplitude ( peak - nadir ) ( 24 + /- 6 % ; P levels of the orexigenic gastroenteric hormone , ghrelin , were suppressed by approximately 30 % 1 - 2 h after ingestion of each HGl meal ( P suppression of ghrelin was significantly less pronounced after HFr meals ( P elevation of plasma triglycerides compared with the HGl day ( P circulating insulin and leptin and increased ghrelin concentrations , as demonstrated in this study , could lead to increased caloric intake and ultimately contribute to weight gain and obesity during chronic consumption of diets high in fructose",
"Consumption of simple carbohydrates has markedly increased over the past decades , and may be involved in the increased prevalence in metabolic diseases . Whether an increased intake of fructose is specifically related to a dysregulation of glucose and lipid metabolism remains controversial . We therefore compared the effects of hypercaloric diets enriched with fructose ( HFrD ) or glucose ( HGlcD ) in healthy men . Eleven subjects were studied in a r and omised order after 7 d of the following diets : ( 1 ) weight maintenance , control diet ; ( 2 ) HFrD ( 3.5 g fructose/kg fat-free mass ( ffm ) per d , + 35 % energy intake ) ; ( 3 ) HGlcD ( 3.5 g glucose/kg ffm per d , + 35 % energy intake ) . Fasting hepatic glucose output ( HGO ) was measured with 6,6 - 2H2-glucose . Intrahepatocellular lipids ( IHCL ) and intramyocellular lipids ( IMCL ) were measured by 1H magnetic resonance spectroscopy . Both fructose and glucose increased fasting VLDL-TAG ( HFrD : + 59 % , P IHCL ( HFrD : + 52 % , P HGO increased after both diets ( HFrD : + 5 % , P fasting glycaemia , insulin and alanine aminotransferase concentrations . IMCL increased significantly only after the HGlcD ( HFrD : + 24 % , NS ; HGlcD : + 59 % , P IHCL and VLDL-TAG were not different between hypercaloric HFrD and HGlcD , but were increased compared to values observed with a weight maintenance diet . However , glucose led to a higher increase in IMCL than fructose",
"OBJECTIVE Fructose has been implicated in obesity , partly due to lack of insulin-mediated leptin stimulation and ghrelin suppression . Most work has examined effects of pure fructose , rather than high-fructose corn syrup ( HFCS ) , the most commonly consumed form of fructose . This study examined effects of beverages sweetened with HFCS or sucrose ( Suc ) , when consumed with mixed meals , on blood glucose , insulin , leptin , ghrelin , and appetite . METHODS Thirty lean women were studied on two r and omized 2-d visits during which HFCS- and Suc-sweetened beverages were consumed as 30 % of energy on isocaloric diets during day 1 while blood was sample d. On day 2 , food was eaten ad libitum . Subjects rated appetite at design ated times throughout visits . RESULTS No significant differences between the two sweeteners were seen in fasting plasma glucose , insulin , leptin , and ghrelin ( P > 0.05 ) . The within-day variation in all four items was not different between the two visits ( P > 0.05 ) . Net areas under the curve were similar for glucose , insulin , and leptin ( P > 0.05 ) . There were no differences in energy or macronutrient intake on day 2 . The only appetite variable that differed between sweeteners was desire to eat , which had a higher area under the curve the day after Suc compared with HFCS . CONCLUSION These short-term results suggest that , when fructose is consumed in the form of HFCS , the measured metabolic responses do not differ from Suc in lean women . Further research is required to examine appetite responses and to determine if these findings hold true for obese individuals , males , or longer periods",
"An increasing amount of fructose in the diet is suggested to play a causal role in the pathogenesis of the metabolic syndrome , type 2 diabetes and fatty liver . Our aim was to investigate and compare the effects of very high fructose and very high glucose in hyperenergetic diets on glucose and lipid metabolism and on fat depots in healthy humans . We conducted an exploratory , prospect i ve , r and omised , single-blinded , intervention trial . Participants in addition to a balanced weight-maintaining diet received 150 g of fructose or glucose/d for 4 weeks . Insulin sensitivity was estimated from oral glucose tolerance tests . Visceral and subcutaneous abdominal fat was determined with MRI . Liver fat and intramyocellular lipids of the tibialis anterior muscle were measured with (1)H magnetic resonance spectroscopy . A total of twenty healthy subjects ( fructose group n 10 and glucose group n 10 ; twelve males and eight females ) completed the study . They had a mean age of 30·5 ( SEM 2·0 ) years and a mean BMI of 25·9 ( SEM 0·5 ) kg/m(2 ) . Insulin sensitivity appeared to decrease both in the fructose and glucose groups . TAG markedly increased in the fructose group . No strong alterations or treatment effects were found for liver fat , visceral fat , subcutaneous abdominal fat and intramyocellular lipids of the tibialis anterior muscle . In conclusion , the effects of very high fructose and very high glucose in hyperenergetic diets on glucose metabolism and body fat composition were not different in the healthy participants of the present study . However , elevation of plasma TAG seemed to be fructose-specific",
" Using a crossover design , eight healthy volunteers r and omly received physiologic amounts ( ⅓ of each subject 's total carbohydrate intake ) of either fructose or sucrose as the primary source of simple sugar , incorporated into isocaloric diets comprised of typical American foods . After 7 and 14 days of consuming either of the two sugars , no change occurred in fasting glucose or insulin levels . In addition , total triglyceride , totalcholesterol , low-density-lipoprotein ( LDL ) cholesterol , and high-density-lipoprotein ( HDL ) cholesterol concentrations were unaltered . Since our study used conventional foods in normal eating patterns rather than contrived formulas or excessive amounts of simple sugar , our data indicate that there is no difference between sucrose or fructose on various lipid components or glucose and fasting insulin levels in the “ real world ” innormal subjects"
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Objective To conduct a systematic review of the literature on the longevity of routine dental restorations in permanent posterior teeth , and to identify and examine factors influencing its variability . Method Accepted guidelines were followed . An advisory group oversaw the project . Simple Class I and Class II amalgam , composite resin , glass ionomer and cast gold restorations were covered . Comprehensive search ing of electronic data bases , h and - search ing , and location of ' grey ' literature , generated 124 research reports . Those considered relevant were assessed for validity and quality according to agreed criteria . The analysis was descriptive . Results Eight of 58 relevant research reports were categorised , according to agreed criteria , as being of satisfactory validity and quality . They suggested that 50 % of all restorations last 10 to 20 years , although both higher and lower median survival times were reported . The findings were supported by the totality of studies review ed . However , variability was substantial . Restoration type , material s , the patient , the operator , the practice environment and type of care system appeared to influence longevity . Conclusions Many studies were imperfect in design . Those considered to be the most appropriate for analysis were too limited to undertake a formal statistical exploration . Therefore there remains a need for definitive r and omised controlled trials of restoration longevity , of sound design and adequate power , employing st and ardised assessment s and appropriate methods of analysis | [
" This paper reports the 5-year findings of a multi clinical ( n = 11 ) trial of a posterior composite restorative . The overall findings , based on data collected from 649 ( 68 per cent ) of the 958 restorations originally included in the study , indicate that the material evaluated satisfies established clinical requirements for posterior composites over periods of up to 5 years . Deviations in the reporting of certain elements of the data appear to have been related to local variations in method",
"Three restorative material s used for cervical erosion /abrasion lesions were evaluated clinical ly after 10 years . Thirty adult patients with at least four cervical lesions received one restoration of each of Ketac-Fil , finished immediately , Ketac-Fil , finished after a delay , Chelon-FIl ( all glass-ionomer cements ) , and Cervident ( a resin composite ) . Restorations were placed without any tooth preparations . Eighteen patients returned for their 10-year examinations . Two experienced examiners provided the periodic evaluations . Complete retention at 10 years was 83 % for Ketac-Fil , finished immediately ; 78 % for Ketac-Fil , finished after a delay ; 67 % for Chelon-Fil ; and 17 % for Cervident . All three glass-ionomer restorative material s exhibited statistically significantly greater retention that did Cervident . When a noninvasive procedure is desired , glass-ionomer material s are the restorative material of choice for abrasion/erosion lesions because of their long-term retention values",
" In a cross-sectional survey the age of restorations in situ was recorded in three patient groups . Group A were r and omly examined regular attenders , group B were irregular attenders r and omly chosen from patient treatment records , and in group C the age of posterior gold and composite resin restorations was recorded in selected regular attenders . The study material included 8310 restorations in group A , 1281 in group B , and 500 restorations in group C. The three material s amalgam , composite , and gold accounted for more than 90 % of all restorations . In group A 3.3 % of the restorations were scheduled for replacement . The most prevalent reasons for replacement were secondary caries , bulk fractures of the restoration , and tooth fractures . The median age of the failed restorations was fairly similar to the median age of the acceptable restorations in situ among the regular patients ( group A ) . The data indicate median ages of 20 years for gold restorations , 12 - 14 years for amalgam restorations , and 7 - 8 years for composite resin restorations . The restoration ages were influenced by the type and size of the restoration , the restorative material used , and possibly also the intra-oral location of the restorations",
"The purpose of this clinical study was to evaluate the factor of the setting rate/Eames working time on fracture at the margins of amalgams . One batch of a high-copper amalgam was modified to obtain two setting rates , one fast and one slow setting . Two dentists originally placed 134 amalgam restorations in 23 patients . Both dentists used a rubber dam throughout the restorative procedure and prepared cavities as conservatively as possible . The amalgams were condensed by h and and carved with sharp instruments . At 1 year 124 restorations and at 2 years 115 restorations were evaluated for fracture at the margins . Results indicated that there was no significant clinical difference between a slow- and fast- setting alloy , nor was there a difference between the operators",
"The purpose of the study was to estimate the influence of different clinical variables on the replacement rate of class-II amalgam restorations in permanent teeth . The study included 210 patients who had 468 restorations placed by 7 Sc and inavian dentists . The observation periods varied between 7 and 10 years . At the time of the last recording 188 restorations remained intact in 88 patients , whereas 68 restorations in 53 patients had been replaced . Eighty-six patients with 212 restorations had dropped out of the study . The most prevalent criteria for replacement were secondary caries ( n = 30 ) and restoration bulk fractures ( n = 24 ) . Chi-square analyses of the relationship between the prevalence of replacements and the clinical variables indicated effects of the operator and the patients ' age and caries activity ( p less than 0.001 ) . Similar results were observed when the functional time of the restorations was related to the clinical variables and analyzed by ANOVA and MCA analyses and by survival analyses using logrank and Wilcoxon tests ( p less than 0.001 ) . The survival analyses using the Lee-Desu statistic D showed in addition a slight difference between the restorations in the lower premolars and upper and lower molars . There were no differences in the clinical performance between four non-gamma-2 alloys and one conventional alloy . Furthermore , no differences were noted between the survival rates of MC , DO , and MOD restorations . In a Cox regression model the strongest effects on the estimated survival rates were associated with the patients ' age and caries activity covariates ( global chi-square = 23.5 , df = 2 , p less than 0.001 ) , whereas the effects of the operator and the other clinical variables were insignificant",
" OBJECTIVE This clinical trial aim ed at study ing the long-term performance in routine clinical practice of saucer-shaped Class II resin composite restorations . METHOD AND MATERIAL S Fifty-one preparations were completed and filled with either of two light-cured posterior composites by seven dentists of the Public Dental Service . The restorations were evaluated annually , using the US Public Health Service criteria , bitewing radiographs , and dies based on replica impressions . At the final evaluation , the recall rate was 100 % . RESULTS After a mean of 7.2 + /- 1.3 years of service ( censored maximum of 9.6 years ) , 70 % of the restorations were acceptable for continued use . Caries and technical deficiencies were the main causes of failure . CONCLUSION The saucer configuration , by respecting and utilizing inherent properties of the resin composites , spares sound dentin and is preferable to the box preparation",
" A group of 71 patients was examined to determine the longevity of restorations placed at the University of North Carolina School of Dentistry . Patients with an overall restorations failure rate of equal to or greater than 40 per 1000 restoration-yr were categorized as having a \" high failure rate \" and those below that were considered \" low failure rate \" . An investigation was made to determine statistical differences between these two groups of patients using survival analysis and various statistical indices . Time of exposure and age of patients for both groups were similar . High rate patients had a greater number of anterior restorations and anterior teeth restored . In addition , the number of restorations per tooth was significantly greater in anterior and posterior teeth of the high failure rate group . No single variable was found to account for the differences in the failure rates in the two groups of patients . A prospect i ve study is needed in order to examine possible causes for restoration failures",
"PURPOSE This paper reports the 5-year performance of the restorations of the high-copper content dental amalgam alloys included in the worldwide programme of clinical trials of Occlusin , including unique data on wear . METHODS The methods employed are common to those previously reported for the multi clinical evaluation of Occlusin . Analysis of the data is limited to simple statistical procedures . RESULTS The findings lend support to existing knowledge concerning the favourable performance of restorations of high-copper content dental amalgam alloys , notably in relation to restorations in moderate- to large-sized Class II preparations in permanent molar teeth . Analysis of the data sheds new light on the influences of variables , including type of tooth restored , size and class of restoration and the presence or absence of occlusal contact(s ) on performance . CONCLUSION Conclusions are drawn regarding ways in which protocol s for future evaluations of the type reported should be exp and ed , and , together with suggestions for further work , it is concluded that this paper is a timely reminder of the value of existing dental amalgam alloys ",
" After 14 years , 40 patients from an in vitro/in vivo study of 12 amalgam alloys were evaluated . All these patients had been attending private practitioners over the past 10 years , and the clinical evaluation revealed that 320 restorations were intact and 47 ( 12.8 % ) had been lost . The majority ( 75.0 % ) of the lost restorations were lost to crown placement or the replacement with another amalgam restoration . The six high-copper alloys exhibited better clinical performance , in both loss rate and fracture at the margins , than did traditional low-copper material s. Fracture at the margins was a better predictor of the loss of a restoration than were mechanical properties",
"In this study 96 teeth of 12 patients were restored with either the conventional alloy Premix , the blended non-gamma 2 amalgam Dispersalloy , or one of the spherical alloys Sybraloy and Tytin . To ascertain an objective comparison of the clinical performance of these alloys , two different alloys were used in each of at least two dental arch quadrants in the same patient and consequently were placed in the same oral environment . Clinical performance of the restorations was evaluated by macrophotography and scanning electron microphotography of replicas made after placement and 2 , 3 , and 5 years thereafter . St and ard criteria were used for the evaluation of anatomic form , surface condition , and marginal adaptation of the fillings . In addition , the filling-enamel interface was assessed from the microphotographs . The three high-copper alloys performed better clinical ly than the conventional alloy , and the spherical alloys had the best qualifications . In addition to visual examination and photographic evaluation of restorations , the micrometric assessment of replica photographs from the scanning electron microscope may render clinical trials of amalgam alloys measurable and less subjective",
"A clinical trial comparing the efficacy of an occlusal amalgam restoration with a minimal composite restoration and fissure sealant in the management of occlusal caries in young patients has been performed . One hundred and fifty pairs of restorations were placed in 103 patients and assessed during the 5-year follow-up period . Nineteen restorations failed during this period : 11 amalgam and 8 minimal composite . There was some deterioration in anatomical form and marginal integrity of the remaining amalgam restorations . Of the remaining minimal composites , seven suffered clinical ly detectable wear and a further five had some marginal staining . Forty-nine of the minimal composites needed to have repairs to the fissure sealant . The amalgam restorations occupied , on average , 25 % of the occlusal surface of the tooth , compared with 5 % for the minimal composite resin . The results after a 5-year follow-up showed no significant difference in median survival times between the amalgam and the minimal composite"
] | 41163b0c-06ff-11f0-808a-c43d1ab1c353 |
QUESTION What is the effectiveness of strategies to increase the implementation of physiotherapy clinical guidelines ? DESIGN Systematic review . PARTICIPANTS Physiotherapists treating any type of patients . INTERVENTION Single or multiple strategies to increase the implementation of physiotherapy clinical guidelines . OUTCOME MEASURES Professional practice , patient health , and cost of care . RESULTS Five papers reporting three cluster-r and omised trials evaluated whether multifaceted strategies based on educational meetings increased the implementation of low back pain guidelines ( 2 trials ) or whiplash guidelines ( 1 trial ) . Educational meetings were effective in increasing adherence to the following recommendations of low back pain guidelines : limiting the number of sessions ( RD 0.13 , 95 % CI 0.03 to 0.23 ) , using active intervention ( RD 0.13 , 95 % CI 0.05 to 0.21 ) , giving adequate information ( RD 0.05 , 95 % CI 0.00 to 0.11 ) , increasing activity level ( RD 0.16 , 95 % CI 0.02 to 0.30 ) , changing attitudes/beliefs about pain ( RD 0.13 , 95 % CI 0.01 to 0.24 ) . Educational meetings were effective in increasing adherence to the following recommendations of whiplash guidelines : reassuring the patient ( RD 0.40 , 95 % CI 0.07 to 0.74 ) , advising the patient to act as usual ( RD 0.48 , 95 % CI 0.15 to 0.80 ) , using functional outcome measures ( RD 0.62 , 95 % CI 0.32 to 0.92 ) . There was no evidence that patient health was improved or that the cost of care was reduced . CONCLUSION This review shows that multifaceted interventions based on educational meetings to increase implementation of clinical guidelines may improve some outcomes of professional practice but do not improve patient health or reduce cost of care . These findings are comparable with results among other health professions | [
"Evidence -based practice involves the use of evidence from systematic review s and r and omised controlled trials , but the extent of this evidence in physiotherapy has not previously been surveyed . The aim of this survey is to describe the quantity and quality of r and omised controlled trials and the quantity of systematic review s relevant to physiotherapy . The Physiotherapy Evidence Data base ( PEDro ) was search ed . The quality of trials was assessed with the PEDro scale . The search identified a total of 2,376 r and omised controlled trials and 332 systematic review s. The first trial was published in 1955 and the first review was published in 1982 . Since that time , the number of trials and review s has grown exponentially . The mean PEDro quality score has increased from 2.8 in trials published between 1955 and 1959 to 5.0 for trials published between 1995 and 1999 . There is a substantial body of evidence about the effects of physiotherapy . However , there remains scope for improvements in the quality of the conduct and reporting of clinical trials",
"Objectives : To evaluate the effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain . Design : A cluster r and omised controlled trial comparing an active strategy with st and ard dissemination . Setting : Primary care physiotherapy practice s. Participants : 113 physiotherapists were r and omly allocated to receive the guidelines by mail ( control group ) or to receive an additional active strategy ( intervention group ) which consisted of a multifaceted programme including education , discussion , role playing , feedback , and reminders . Main outcome measures : Adherence to the guidelines was measured by means of individual patients ’ forms recording the treatment completed by the physiotherapist . The forms were assessed using an algorithm based on the number of treatment sessions , treatment goals , interventions , and patient education . Results : Physiotherapists in the intervention group more often correctly limited the number of treatment sessions for patients with a normal course of back pain ( OR 2.39 ; 95 % CI 1.12 to 5.12 ) , more often set functional treatment goals ( OR 1.99 ; 95 % CI 1.06 to 3.72 ) , more often used mainly active interventions ( OR 2.79 ; 95 % CI 1.19 to 6.55 ) , and more often gave adequate patient education ( OR 3.59 ; 95 % CI 1.35 to 9.55 ) . They also adhered more to all four criteria ( OR 2.05 ; 95 % CI 1.15 to 3.65 ) . Conclusions : The active strategy moderately improved adherence to the guidelines . Active strategies are recommended to implement the clinical guidelines on physiotherapy for low back pain",
"BACKGROUND AND PURPOSE An active strategy was developed for the implementation of the clinical guidelines on physical therapy for patients with low back pain . The effect of this strategy on patients ' physical functioning , coping strategy , and beliefs regarding their low back pain was studied . SUBJECTS One hundred thirteen primary care physical therapists treated a total of 500 patients . METHODS The physical therapists were r and omly assigned to 1 of 2 groups . The control group received the guidelines by mail ( st and ard passive method of dissemination ) . The intervention group , in contrast , received an additional active training strategy consisting of 2 sessions with education , group discussion , role playing , feedback , and reminders . Patients with low back pain , treated by the participating therapists , completed question naires on physical functioning , pain , sick leave , coping , and beliefs . RESULTS Physical functioning and pain in the 2 groups improved substantially in the first 12 weeks . Multilevel longitudinal analysis showed no differences between the 2 groups on any outcome measure during follow-up . DISCUSSION AND CONCLUSION The authors found no additional benefit to applying an active strategy to implement the physical therapy guidelines for patients with low back pain . Active implementation strategies are not recommended if patient outcomes are to be improved",
"Background Clinical guidelines are considered important instruments to improve quality in health care . In physiotherapy , insight in adherence to guidelines is limited . Knowledge of adherence is important to identify barriers and to enhance implementation . Purpose of this study is to investigate the ability to adherence to recommendations of the guideline Acute ankle injury , and to identify patient characteristics that determine adherence to the guideline . Methods Twenty-two physiotherapists collected data of 174 patients in a prospect i ve cohort study , in which the course of treatment was systematic ally registered . Indicators were used to investigate adherence to recommendations . Patient characteristics were used to identify prognostic factors that may determine adherence to the guideline . Correlation between patient characteristics and adherence to outcome -indicators ( treatment sessions , functioning of patient , accomplished goals ) was calculated using univariate logistic regression . To calculate explained variance of combined patient characteristics , multivariate analysis was performed . Results Adherence to individual recommendations varied from 71 % to 100 % . In 99 patients ( 57 % ) the physiotherapists showed adherence to all indicators . Adherence to preset maximum of six treatment sessions for patients with severe ankle injury was 81 % ( 132 patients ) .The odds to receive more than six sessions were statistically significant for three patient characteristics : females ( OR:3.89 ; 95%CI : 1.41–10.72 ) , recurrent sprain ( OR : 6.90 ; 95%CI : 2.34 – 20.37 ) , co-morbidity ( OR : 25.92 ; 95 % CI : 6.79 – 98.93 ) . All factors together explained 40 % of the variance . Inclusion of physiotherapist characteristics in the regression model showed that work-experience reduced the odds to receive more than six sessions ( OR : 0.2 ; 95%CI : 0.06 – 0.77 ) , and increased explained variance to 45 % . Conclusion Adherence to the clinical guideline Acute ankle sprain showed that the guideline is applicable in daily practice . Adherence to the guideline , even in a group of physiotherapists familiar with the guideline , showed possibilities for improvement . The necessity to exceed the expected number of treatment sessions may be explained by co-morbidity and recurrent sprains . It is not clear why female patients were treated with more sessions . Experience of the physiotherapist reduced the number of treatment sessions . Quality indicators may be used for audit and feedback as part of the implementation strategy",
"QUESTION Are implementation strategies involving education any more effective than mere dissemination of clinical practice guidelines in changing physiotherapy practice and reducing patient disability after acute whiplash ? DESIGN Cluster-r and omised trial . PARTICIPANTS Twenty-seven physiotherapists from different private physiotherapy clinics and the 103 patients ( 4 dropouts ) who presented to them with acute whiplash . INTERVENTION The implementation group of physiotherapists underwent education by opinion leaders about whiplash guidelines and the dissemination group had the guidelines mailed to them . OUTCOME MEASURES The primary outcome was patient disability , measured using the Functional Rating Index , collected on admission to the trial and at 1.5 , 3 , 6 and 12 months . Physiotherapist knowledge about the guidelines was measured using a custom-made question naire . Physiotherapist practice and cost of care were measured by audit of patient notes . RESULTS There were no significant differences between groups for any of the patient outcomes at any time . The implementation patients had 0.6 points ( 95 % CI -7.8 to 6.6 ) less disability than the dissemination patients at 12 months ; 44 % more physiotherapists in the implementation group reported that they prescribed two out of the five guideline -recommended treatments ; and 32 % more physiotherapists actually prescribed them . The cost of care for patients in the implementation group was $ 255 ( 95 % CI -1505 to 996 ) less than for patients in the dissemination group . CONCLUSION Although the active implementation program increased guideline -consistent practice , patient outcomes and cost of care were not affected",
"Background Low back pain ( LBP ) is a common and costly problem . Initiatives design ed to assist practitioner and patient decisions about appropriate healthcare for LBP include printed evidence -based clinical guidelines . The three professional groups of chiropractic , osteopathy and musculoskeletal physiotherapy in the UK share common ground with their approaches to managing LBP and are amongst those targeted by LBP guidelines . Even so , many seem unaware that such guidelines exist . Furthermore , the behaviour of at least some of these practitioners differs from that recommended in these guidelines .Few r and omised controlled trials evaluating printed information as an intervention to change practitioner behaviour have utilised a no-intervention control . All these trials have used a cluster design and most have method ological flaws . None specifically focus upon practitioner behaviour towards LBP patients . Studies that have investigated other strategies to change practitioner behaviour with LBP patients have produced conflicting results . Although numerous LBP guidelines have been developed worldwide , there is a paucity of data on whether their dissemination actually changes practitioner behaviour . Primarily because of its low unit cost , sending printed information to large numbers of practitioners is an attractive dissemination and implementation strategy . The effect size of such a strategy , at an individual practitioner level , is likely to be small . However , if large numbers of practitioners are targeted , this strategy might achieve meaningful changes at a population level . Methods The primary aim of this prospect i ve , pragmatic r and omised controlled trial is to test the short-term effectiveness ( six-months following intervention ) of a directly-posted information package on the reported clinical behaviour ( primary outcome ) , attitudes and beliefs of UK chiropractors , osteopaths and musculoskeletal physiotherapists . We sought to r and omly allocate a combined sample of 1,800 consenting practitioners to receive either the information package ( intervention arm ) or no information above that gained during normal practice ( control arm ) . We collected question naire data at baseline and six-months post-intervention . The analysis of the primary outcome will assess between-arm differences of proportions of responses to questions on recommendations about activity , work and bed-rest , that fall within categories previously defined by an expert consensus exercise as either ' guideline -consistent ' and ' guideline -inconsistent '",
"QUESTION What is the compliance with guidelines for acute ankle sprain for physiotherapists ? DESIGN Survey of r and om sample of physiotherapists . PARTICIPANTS 400 physiotherapists working in extramural health care in the Netherl and s. OUTCOME MEASURES Questions covered attitude towards guidelines in general , familiarity with the guidelines for acute ankle sprain , compliance with the guidelines , advantages and disadvantages of the guidelines , and factors relating to compliance with the guidelines . RESULTS The majority of the physiotherapists were familiar with the content of the guidelines to some degree and 66%applied it to more than half of their patients with acute ankle sprain . The recommendations to determine both the prognosis and the necessity of treatment by using the function score were the least followed . Some physiotherapists thought the function score was not completely clear , which may have been a barrier for implementation . Factors relating positively to compliance were a positive attitude towards guidelines in general , and having colleagues who implemented the guidelines for acute ankle sprain . CONCLUSION Although compliance with the guidelines for acute ankle sprain was fair/moderate , compliance may be enhanced by improving clarity of the function score , including it in the short version and improving the attitude of physiotherapists towards guidelines in general",
"RATIONALE The concept of evidence -based medicine is important in providing efficient health care . The process uses research findings as the basis for clinical decision making . Evidence -based practice helps optimize current health care and enables the practitioners to be suitably accountable for the interventions they provide . Little work has been undertaken to examine how allied health professionals change their clinical practice in light of the latest evidence . The use of opinion leaders to disseminate new evidence around the management of low back pain into practice has been proposed . AIMS The aim of this study was to investigate if physiotherapists ' clinical management of patients with low back pain would change following an evidence -based education package , which utilized local opinion leaders and delivered the best evidence . METHOD Thirty musculoskeletal physiotherapists from a Community Trust in North Staffordshire were cluster r and omized by location of work , to two groups . The intervention group received an evidence -based programme on the management of low back pain , including advice regarding increasing activity levels and return to normal activity and challenging patients ' fears and beliefs about their pain . The control group received a st and ard in-service training package on the management of common knee pathologies . The physiotherapists ' clinical management of patients with low back pain was measured prior to training and 6 months post training . Outcome measures were based on physiotherapists completing ' discharge summary ' question naires , which included information relating to the use and importance of therapies for treating their low back pain patients . RESULTS There were few significant differences in treatment options between the intervention and control groups post training . Whilst there was some indication that physiotherapists were already utilizing aspects of psychosocial management for patients with low back pain , there was little change in what physiotherapists perceived to be important to patient recovery and actual clinical practice following the intervention . CONCLUSIONS Psychosocial factors have been identified as an important factor in the recovery of patients with low back pain . This project incorporated the latest evidence on the management of low back pain and utilized the theory of opinion leaders to disseminate this evidence into clinical practice . Whilst there were some limitations in the overall size of the study , the results help to give an insight into the challenges faced by the health care system and research ers alike to ensure quality evidence is actually utilized by practitioners for the benefits of patient care",
"Study Design . Data were derived from a r and omized controlled trial on the ( cost- ) effectiveness of the implementation of the clinical guidelines on physiotherapy for low back pain in primary care . Objectives . To describe the course of low back pain in patients who are referred to physiotherapy , to identify clinical ly important prognostic factors on different outcomes , and to evaluate the influence of different statistical techniques in developing a prognostic model . Summary of Background Data . Several studies have aim ed to identify prognostic factors for low back pain in primary care . These studies focused on different outcome measures and used various statistical techniques . Methods . Primary outcomes were perceived recovery , improvement in pain , improvement in functioning , and presence of disabling low back pain at 3 and 12 months follow-up . Multivariate logistic regression analyses were performed for each outcome variable . Two cut-off points were used to determine significance with respect to the univariate analysis , and two selection methods were used to build the final multivariate models . The result ing prognostic models were compared . Results . A total of 500 patients were included . Pain and disability reduced considerably in the first 3 months , but further reduction was only modest . Prognostic factors varied for different outcomes , but the duration of the current episode was included in all models generated . Varying the statistical techniques also result ed in a different prognostic model with some change to the amount of variance explained . Conclusions . A substantial proportion of patients still experienced some pain and disability at 12 months follow-up . The most stable predictor of prognosis in low back pain was the duration of the current episode . The choice of statistical method influenced the final model ; however , changes in the explained variance were small"
] | 41163b52-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Many physiotherapists underuse evidence -based practice guidelines or recommendations when treating patients with musculoskeletal disorders , yet synthesis of knowledge translation interventions used within the field of physiotherapy fails to offer clear conclusions to guide the implementation of clinical practice guidelines . OBJECTIVES To evaluate the effectiveness of various knowledge translation interventions used to implement changes in the practice of current physiotherapists treating common musculoskeletal issues . DATA SOURCES A computerized literature search of MEDLINE , CINHAL and ProQuest of systematic review s ( from inception until May 2016 ) and primary research studies ( from January 2010 until June 2016 ) . STUDY SELECTION AND ELIGIBILITY CRITERIA Eligibility criteria specified articles evaluating interventions for translating knowledge into physiotherapy practice . DATA EXTRACTION AND DATA SYNTHESIS Two review ers independently screened the titles and abstract s , review ed full-text articles , performed data extraction , and performed quality assessment . Of a total of 13014 articles located and titles and abstract s screened , 34 studies met the inclusion criteria , including three overlapping publications , result ing in 31 individual studies . RESULTS Knowledge translation interventions appear to have result ed in a positive change in physiotherapist beliefs , attitudes , skills and guideline awareness . However , no consistent improvement in clinical practice , patient and economic outcomes were observed . LIMITATIONS The studies included had small sample sizes and low method ological quality . The heterogeneity of the studies was not conducive to pooling the data . CONCLUSIONS AND IMPLICATION OF KEY FINDINGS The intensity and type of knowledge translation intervention seem to have an effect on practice change . More research targeting financial , organizational and regulatory knowledge translation interventions is needed | [
"Background Clinical practice guidelines ( CPGs ) are not readily implemented in clinical practice . One of the impeding factors is that physical therapists do not hold realistic perceptions of their adherence to CPGs . Peer assessment ( PA ) is an implementation strategy that aims at improving guideline adherence by enhancing reflective practice , awareness of professional performance , and attainment of personal goals . Objective The purpose of this study was to compare the effectiveness of PA with the usual case discussion ( CD ) strategy on adherence to CPGs for physical therapist management of upper extremity complaints . Design A single-masked , cluster-r and omized controlled trial with pretest-posttest design was conducted . Intervention Twenty communities of practice ( n=149 physical therapists ) were r and omly assigned to groups receiving PA or CD , with both interventions consisting of 4 sessions over 6 months . Both PA and CD groups worked on identical clinical cases relevant to the guidelines . Peer assessment focused on individual performance observed and evaluated by peers ; CD focused on discussion . Outcomes Guideline adherence was measured with clinical vignettes , reflective practice was measured with the Self-Reflection and Insight Scale ( SRIS ) , awareness of performance was measured via the correlation between perceived and assessed improvement , and attainment of personal goals was measured with written commitments to change . Results The PA groups improved more on guideline adherence compared with the CD groups ( effect=22.52 ; 95 % confidence interval [ 95 % CI]=2.38 , 42.66 ; P=.03 ) . The SRIS scores did not differ between PA and CD groups . Awareness of performance was greater for the PA groups ( r=.36 ) than for the CD groups ( r=.08 ) ( effect=14.73 ; 95 % CI=2.78 , 26.68 ; P=.01 ) . The PA strategy was more effective than the CD strategy in attaining personal goals ( effect=0.50 ; 95 % CI=0.04 , 0.96 ; P=.03 ) . Limitations Limited validity of clinical vignettes as a proxy measure of clinical practice was a limitation of the study . Conclusions Peer assessment was more effective than CD in improving adherence to CPGs . Personal feedback may have contributed to its effectiveness . Future research should address the role of the group coach",
"Background Psychosocial prognostic factors are important in the development of chronic pain , but treatment providers often lack knowledge and skills to assess and address these risk factors . Objective The aim of this study was to examine the effects on outcomes ( pain and disability ) in patients of a course about psychosocial prognostic factors for physical therapists . Design This study was a r and omized , controlled trial . Setting The setting was primary care practice . Participants Forty-two primary care physical therapists attended an 8-day university course ( over 8 weeks ) aim ed at identifying and addressing psychosocial risk factors . Intervention The physical therapists were r and omly assigned to either the course or a waiting list . They treated consecutive patients with acute and subacute musculoskeletal pain both before and after the course . Measurements We measured physical therapists ' attitudes and beliefs about psychosocial factors , knowledge , and skills before and after the course . We measured patients ' pain , disability , catastrophizing , and mood at the start of treatment and at a 6-month follow-up . Methods The physical therapists were r and omly assigned to either the course or a waiting list . They treated consecutive patients with acute and subacute musculoskeletal pain both before and after the course . Results Pain and disability outcomes in all patients of physical therapists who had participated in the course or in patients at risk of developing long-term disability who had higher levels of catastrophizing or depression were not significantly different from those outcomes in patients of physical therapists who had not participated in the course . Pain and disability outcomes in patients with a low risk of developing long-term disability— and pain outcomes in patients with a high risk of developing long-term disability — were not dependent upon whether the attitudes and beliefs of their physical therapists changed during the course . However , disability outcomes in patients with a high risk of developing long-term disability may have been influenced by whether the attitudes and beliefs of their physical therapists changed . Limitations A limitation of this study was that actual practice behavior was not measured . Conclusions An 8-day university course for physical therapists did not improve outcomes in a group of patients as a whole or in patients with a risk of developing long-term disability . However , patients who had a risk of developing long-term disability and had higher levels of catastrophizing or depression may have shown greater reductions in disability if the attitudes and beliefs of their physical therapists changed during the course",
"OBJECTIVE To provide access to professional development opportunities for health care professionals , especially in rural Australian regions , consistent with recommendations in the Australian National Pain Strategy and state government policy . DESIGN AND SETTING A preliminary prospect i ve , single-cohort study design , which aligned health policy with evidence -informed clinical practice , evaluated the implementation and effectiveness of an interprofessional , health care provider pain education program ( hPEP ) for management of nonspecific low back pain ( nsLBP ) in rural Western Australia . INTERVENTION The 6.5-hour hPEP intervention was delivered to 60 care providers ( caseload nsLBP 19.8 % ± 22.5 ) at four rural WA regions . OUTCOME MEASURES Outcomes were recorded at baseline and 2 months post-intervention regarding attitudes , beliefs ( modified Health Care Providers Pain and Impairment Relationship Scale [ HC-PAIRS ] ) , Back Pain Beliefs Question naire [ BBQ ] ) , and self-reported evidence -based clinical practice ( knowledge and skills regarding nsLBP , rated on a 5-point Likert scale with 1 = nil and 5 = excellent ) . RESULTS hPEP was feasible to implement . At 2 months post-hPEP , responders ' ( response rate 53 % ) improved evidence -based beliefs were indicated by HC-PAIRS scores : baseline mean ( SD ) [ 43.2 ( 9.3 ) ] ; mean difference ( 95 % CI ) [ -5.9 ( -8.6 to -3.1 ) ] ; and BBQ baseline [ 34.3 ( 6.8 ) ] ; mean difference [ 2.1 ( 0.5 to 3.6 ) ] . Positive shifts were observed for all measures of clinical knowledge and skills ( P increased assistance with planning lifestyle changes ( P advice on self-management ( P = 0.010 ) , and for decreased referrals for spinal imaging ( P = 0.03 ) . CONCLUSIONS This policy-into- practice educational program is feasible to implement in rural Western Australia ( WA ) . While preliminary data are encouraging , a further r and omized controlled trial is recommended",
"Objectives : To evaluate the effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain . Design : A cluster r and omised controlled trial comparing an active strategy with st and ard dissemination . Setting : Primary care physiotherapy practice s. Participants : 113 physiotherapists were r and omly allocated to receive the guidelines by mail ( control group ) or to receive an additional active strategy ( intervention group ) which consisted of a multifaceted programme including education , discussion , role playing , feedback , and reminders . Main outcome measures : Adherence to the guidelines was measured by means of individual patients ’ forms recording the treatment completed by the physiotherapist . The forms were assessed using an algorithm based on the number of treatment sessions , treatment goals , interventions , and patient education . Results : Physiotherapists in the intervention group more often correctly limited the number of treatment sessions for patients with a normal course of back pain ( OR 2.39 ; 95 % CI 1.12 to 5.12 ) , more often set functional treatment goals ( OR 1.99 ; 95 % CI 1.06 to 3.72 ) , more often used mainly active interventions ( OR 2.79 ; 95 % CI 1.19 to 6.55 ) , and more often gave adequate patient education ( OR 3.59 ; 95 % CI 1.35 to 9.55 ) . They also adhered more to all four criteria ( OR 2.05 ; 95 % CI 1.15 to 3.65 ) . Conclusions : The active strategy moderately improved adherence to the guidelines . Active strategies are recommended to implement the clinical guidelines on physiotherapy for low back pain",
"BACKGROUND AND PURPOSE An active strategy was developed for the implementation of the clinical guidelines on physical therapy for patients with low back pain . The effect of this strategy on patients ' physical functioning , coping strategy , and beliefs regarding their low back pain was studied . SUBJECTS One hundred thirteen primary care physical therapists treated a total of 500 patients . METHODS The physical therapists were r and omly assigned to 1 of 2 groups . The control group received the guidelines by mail ( st and ard passive method of dissemination ) . The intervention group , in contrast , received an additional active training strategy consisting of 2 sessions with education , group discussion , role playing , feedback , and reminders . Patients with low back pain , treated by the participating therapists , completed question naires on physical functioning , pain , sick leave , coping , and beliefs . RESULTS Physical functioning and pain in the 2 groups improved substantially in the first 12 weeks . Multilevel longitudinal analysis showed no differences between the 2 groups on any outcome measure during follow-up . DISCUSSION AND CONCLUSION The authors found no additional benefit to applying an active strategy to implement the physical therapy guidelines for patients with low back pain . Active implementation strategies are not recommended if patient outcomes are to be improved",
"OBJECTIVE Our purpose was to measure the agreement , reliability , construct validity , and feasibility of a measurement tool to assess systematic review s ( AMSTAR ) . STUDY DESIGN AND SETTING We r and omly selected 30 systematic review s from a data base . Each was assessed by two review ers using : ( 1 ) the enhanced quality assessment question naire ( Overview of Quality Assessment Question naire [ OQAQ ] ) ; ( 2 ) Sacks ' instrument ; and ( 3 ) our newly developed measurement tool ( AMSTAR ) . We report on reliability ( interobserver kappas of the 11 AMSTAR items ) , intraclass correlation coefficients ( ICCs ) of the sum scores , construct validity ( ICCs of the sum scores of AMSTAR compared with those of other instruments ) , and completion times . RESULTS The interrater agreement of the individual items of AMSTAR was substantial with a mean kappa of 0.70 ( 95 % confidence interval [ CI ] : 0.57 , 0.83 ) ( range : 0.38 - 1.0 ) . Kappas recorded for the other instruments were 0.63 ( 95 % CI : 0.38 , 0.78 ) for enhanced OQAQ and 0.40 ( 95 % CI : 0.29 , 0.50 ) for the Sacks ' instrument . The ICC of the total score for AMSTAR was 0.84 ( 95 % CI : 0.65 , 0.92 ) compared with 0.91 ( 95 % CI : 0.82 , 0.96 ) for OQAQ and 0.86 ( 95 % CI : 0.71 , 0.94 ) for the Sacks ' instrument . AMSTAR proved easy to apply , each review taking about 15 minutes to complete . CONCLUSIONS AMSTAR has good agreement , reliability , construct validity , and feasibility . These findings need confirmation by a broader range of assessors and a more diverse range of review",
"Background Clinical practice guidelines are important for transmitting research findings into practice and facilitating the application of evidence -based practice ( EBP ) . There is a paucity of knowledge about the impact of guideline implementation strategies in primary care physical therapy . The aim of this study was to evaluate the effect of a guideline implementation intervention in primary care physical therapy in western Sweden . Methods An implementation strategy based on theory and current evidence was developed . A tailored , multi-component implementation intervention , addressing earlier identified determinants , was carried out in three areas comprising 28 physical therapy practice s including 277 physical therapists ( PTs ) ( intervention group ) . In two adjacent areas , 171 PTs at 32 practice s received no intervention ( control group ) . The core component of the intervention was an implementation seminar with group discussion s. Among other components were a website and email reminders . Data were collected at baseline and follow-up with a web-based question naire . Primary outcomes were the self-reported awareness of , knowledge of , access to , and use of guidelines . Secondary outcomes were self-reported attitudes toward EBP and guidelines . Analyses were performed using Pearson ’s χ2 test and approximative z-test . Results 168 PTs ( 60.6 % ) in the intervention group and 88 PTs ( 51.5 % ) in the control group responded to the follow-up question naire . 186/277 PTs ( 67.1 % ) participated in the implementation seminars , of which 97 ( 52.2 % ) responded . The proportions of PTs reporting awareness of ( absolute difference in change 20.6 % , p = 0.023 ) , knowledge where to find ( 20.4 % , p = 0.007 ) , access to ( 21.7 % , p frequent use of ( 9.5 % , NS ) guidelines increased more in the intervention group than in the control group . The proportion of PTs reporting frequent guideline use after participation in the implementation seminar was 15.2 % ( p = 0.043 ) higher than the proportion in the control group . A higher proportion considered EBP helpful in decision making ( p = 0.018 ) . There were no other significant differences in secondary outcomes . Conclusions A tailored , theory- and evidence -informed , multi-component intervention for the implementation of clinical practice guidelines had a modest , positive effect on awareness of , knowledge of , access to , and use of guidelines , among PTs in primary care in western Sweden . In general , attitudes to EBP and guidelines were not affected",
"Systematic review s provide the best evidence on the effectiveness of healthcare interventions including quality improvement strategies . The methods of systematic review of individual patient r and omised trials of healthcare interventions are well developed . We discuss method ological and practice issues that need to be considered when undertaking systematic review s of quality improvement strategies including developing a review protocol , identifying and screening evidence sources , quality assessment and data abstract ion , analytical methods , reporting systematic review s , and appraising systematic review s. This paper builds on our experiences within the Cochrane Effective Practice and Organisation of Care ( EPOC ) review group",
"Background Clinical practice guidelines are considered important instruments to improve quality of care . However , success is dependent on adherence , which may be improved using peer assessment , a strategy in which professionals assess performance of their peers in a simulated setting . Objective The aim of this study was to determine whether peer assessment is more effective than case-based discussion s to improve knowledge and guideline -consistent clinical reasoning in the Dutch physical therapy guideline for low back pain ( LBP ) . Design A cluster r and omized controlled trial was conducted . Setting and Participants Ten communities of practice ( CoPs ) of physical therapists were cluster r and omized ( N=90 ) : 6 CoPs in the peer- assessment group ( n=49 ) and 4 CoPs in the case-based discussion group ( control group ) ( n=41 ) . Intervention Both groups participated in 4 educational sessions and used clinical patient cases . The peer- assessment group reflected on performed LBP management in different roles . The control group used structured discussion s. Measurements Outcomes were assessed at baseline and at 6 months . The primary outcome measure was knowledge and guideline -consistent reasoning , measured with 12 performance indicators using 4 vignettes with specific guideline -related patient profiles . For each participant , the total score was calculated by adding up the percentage scores ( 0–100 ) per vignette , divided by 4 . The secondary outcome measure was reflective practice , as measured by the Self-Reflection and Insight Scale ( 20–100 ) . Results Vignettes were completed by 78 participants ( 87 % ) . Multilevel analysis showed an increase in guideline -consistent clinical reasoning of 8.4 % in the peer- assessment group , whereas the control group showed a decline of 0.1 % ( estimated group difference=8.7 % , 95 % confidence interval=3.9 to 13.4 ) . No group differences were found on self-reflection . Limitations The small sample size , a short-term follow-up , and the use of vignettes as a proxy for behavior were limitations of the study . Conclusions Peer assessment leads to an increase in knowledge and guideline -consistent clinical reasoning",
"QUESTION Are implementation strategies involving education any more effective than mere dissemination of clinical practice guidelines in changing physiotherapy practice and reducing patient disability after acute whiplash ? DESIGN Cluster-r and omised trial . PARTICIPANTS Twenty-seven physiotherapists from different private physiotherapy clinics and the 103 patients ( 4 dropouts ) who presented to them with acute whiplash . INTERVENTION The implementation group of physiotherapists underwent education by opinion leaders about whiplash guidelines and the dissemination group had the guidelines mailed to them . OUTCOME MEASURES The primary outcome was patient disability , measured using the Functional Rating Index , collected on admission to the trial and at 1.5 , 3 , 6 and 12 months . Physiotherapist knowledge about the guidelines was measured using a custom-made question naire . Physiotherapist practice and cost of care were measured by audit of patient notes . RESULTS There were no significant differences between groups for any of the patient outcomes at any time . The implementation patients had 0.6 points ( 95 % CI -7.8 to 6.6 ) less disability than the dissemination patients at 12 months ; 44 % more physiotherapists in the implementation group reported that they prescribed two out of the five guideline -recommended treatments ; and 32 % more physiotherapists actually prescribed them . The cost of care for patients in the implementation group was $ 255 ( 95 % CI -1505 to 996 ) less than for patients in the dissemination group . CONCLUSION Although the active implementation program increased guideline -consistent practice , patient outcomes and cost of care were not affected",
"Background Guideline adherence in physical therapy is far from optimal , which has consequences for the effectiveness and efficiency of physical therapy care . Programmes to enhance guideline adherence have , so far , been relatively ineffective . We systematic ally developed a theory-based Quality Improvement in Physical Therapy ( QUIP ) programme aim ed at the individual performance level ( practicing physiotherapists ; PTs ) and the practice organization level ( practice quality manager ; PQM ) . The aim of the study was to pilot test the multilevel QUIP programme ’s effectiveness and the fidelity , acceptability and feasibility of its implementation . Methods A one-group , pre-test , post-test pilot study ( N = 8 practice s ; N = 32 PTs , 8 of whom were also PQMs ) done between September and December 2009 . Guideline adherence was measured using clinical vignettes that addressed 12 quality indicators reflecting the guidelines ’ main recommendations . Determinants of adherence were measured using quantitative methods ( question naires ) . Delivery of the programme and management changes were assessed using qualitative methods ( observations , group interviews , and document analyses ) . Changes in adherence and determinants were tested in the paired sample s T-tests and expressed in effect sizes ( Cohen ’s d ) . Results Overall adherence did not change ( 3.1 % ; p = .138 ) . Adherence to three quality indicators improved ( 8 % , 24 % , 43 % ; .000 ≤ p ≤ .023 ) . Adherence to one quality indicator decreased ( −15.7 % ; p = .004 ) . Scores on various determinants of individual performance improved and favourable changes at practice organizational level were observed . Improvements were associated with the programme ’s multilevel approach , collective goal setting , and the application of self-regulation ; unfavourable findings with programme deficits . The one-group pre-test post-test design limits the internal validity of the study , the self-selected sample its external validity . Conclusions The QUIP programme has the potential to change physical therapy practice but needs considerable revision to induce the ongoing quality improvement process that is required to optimize overall guideline adherence . To assess its value , the programme needs to be tested in a r and omized controlled trial",
"The aim of this study is to assess the reported quality of r and omized controlled trials ( RCTs ) on the effectiveness of neglect rehabilitation using a st and ardized scale . A search of seven electronic data bases was carried out . Selected articles were scored using the PEDro scale and classified as high or low quality study both with the original cut off of 6 and a modified cut off of 5 . A linear regression analysis between year of publication and quality rate was used to test whether the quality of the studies improved with time . A total of 18 RCTs were selected . Six articles ( 33.3 % ) and 10 articles ( 55.56 % ) were classified as having high quality when the original cut off or the modified cut off of the PEDro scale were used , respectively . Analysis shows no time-related changes in PEDro scores . The results show that reported quality is moderate for RCTs in neglect rehabilitation",
"RATIONALE The concept of evidence -based practice ( EBP ) encourages health care professionals to provide the most effective health care , and to be accountable for the interventions they provide . Little work has been undertaken to examine how practically allied health professionals ' encompass EBP and how they perceptive and underst and the concept of EBP . The use of opinion leaders to disseminate new evidence into practice , and thereby encourage the behaviour of health care professionals has been proposed . AIMS The aims of this study were to investigate physiotherapists ' attitudes towards EBP and to examine change in their attitudes following an education package , which utilized local opinion leaders . METHOD Thirty musculoskeletal physiotherapists from a Community Trust in North Staffordshire were cluster r and omized by location of work to two groups . The intervention group received an evidence -based programme on aspects of EBP including literature search ing and critical appraisal . The attention control group received a st and ard in-service training package on the management of common knee pathologies . The physiotherapists ' attitudes towards EBP were measured at baseline ( before r and omization ) and at 3 and 6 months follow-up . RESULTS Physiotherapists reported that they primarily relied on ' courses ' and ' in-service training ' for informing their clinical practice . Most agreed that clinical practice should be based on the best available evidence and that they would change their clinical practice if evidence suggested they should do so . However , many of the physiotherapists reported difficulty in reading journals and could not identify opinion leaders in key areas . In terms of clinical practice , literature , journals and research were ascribed low priority throughout . Differences in attitudes between the intervention and control groups were observed in relation to management support for EBP at 3 and 6 months follow-up . CONCLUSIONS In this study , physiotherapists appeared to be in favour of the idea of EBP , yet they remained reluctant to change their practice . Opinion leaders were not easily identifiable by physiotherapists , suggesting that this method alone may not be an effective method of changing attitudes in clinical practice . The process of changing attitudes in the clinical environment is a complex issue worthy of further research",
"Study Design . R and omized controlled trial . Objective . To investigate the effect of a printed information package on the low back pain (LBP)-related beliefs and reported behavior of musculoskeletal practitioners ( chiropractors , osteopaths , and musculoskeletal physiotherapists ) across the United Kingdom . Summary of Background Data . A substantial proportion of musculoskeletal practitioners in United Kingdom does not follow current LBP guideline recommendations . Methods . In total , 1758 practitioners were r and omly allocated to either of the 2 study arms . One arm was posted a printed information package containing guideline recommendations for the management of LBP ( n = 876 ) and the other received no intervention ( n = 882 ) . The primary outcome measure consisted of 3 “ quality indicators ” ( activity , work , and bed-rest ) relating to a vignette of a patient with LBP , in which responses were dichotomized into either “ guideline -inconsistent ” or “ guideline -consistent . ” The secondary outcome was the practitioners ' LBP-related beliefs , measured using the Health Care Providers Pain and Impairment Relationship Scale . Outcomes were measured at baseline and at 6 months . Results . Follow-up at 6 months was 89 % . The changes in reported behavior on the quality indicators were as follows : activity , odds ratio ( OR ) 1.29 ( 95 % confidence interval , 1.03–1.61 ) and number needed to be treated ( NNT ) , 19 ( 15–28 ) ; work , OR 1.35 ( 1.07–1.70 ) and NNT 19 ( 14–29 ) ; and bed-rest , OR 1.31 ( 0.97–1.76 ) and NNT 47 ( 33–103 ) . The composite NNT for a change from guideline -inconsistent to guideline -consistent behavior on at least 1 of the 3 quality indicators was 10 ( 9–14 ) . LBP-related beliefs were significantly improved in those who were sent the information package ( P = 0.002 ) , but only to a small degree ( mean difference , 0.884 scale points ; 95 % confidence interval , 0.319–1.448 ) . Conclusion . Printed educational material can shift LBP-related beliefs and reported behaviors of musculoskeletal practitioners , toward practice that is more in line with guideline recommendations",
"Abstract Purpose : To determine the effectiveness of an interactive educational intervention on a physiotherapy guideline for hip and knee osteoarthritis . Method : Physiotherapists were r and omly allocated to a 3-h interactive educational course with the collaboration of three patient partners or no intervention . Assessment s comprised question naires on adherence ( score range 0–24 ) , knowledge ( score range 0–76 ) , and barriers to use the guideline ( score range 0–80 ) . Assessment s were conducted 1 week before the interactive course ( T0 ) immediately after ( T1 ) , and 3 months thereafter ( T2 ) . Change scores were compared between the groups by means of Mann – Whitney U tests and linear mixed models . Results : 284 of 4328 eligible PTs ( 7 % ) were included . The intervention ( n = 133 ) was significantly more effective than no intervention ( n = 151 ) concerning self-reported adherence and knowledge with mean differences in change scores ( 95 % CI ) at T1 and T2 being 1.4 ( 0.7–2.0 ) and 0.9 ( 0.2–1.7 ) for adherence and 6.8 ( 4.5–9.1 ) and 3.9 ( 1.7–6.2 ) for knowledge , ( all p values the barrier score increased at T1 and decreased at T2 , with a significantly larger increase at T1 and decrease at T2 in the intervention group ( mean differences 3.1 ( 1.8–4.4 ) and 3.3 ( 0.5–6.1 ) , respectively . Conclusions : A short interactive educational course with patient participation on a PT guideline on hip and knee osteoarthritis showed a small to moderate positive effect on self-reported guideline adherence and knowledge , whereas for perceived barriers an advantage was only seen on the longer term . Implication s for Rehabilitation Continuing professional development is important and effective , it works very well when patients are engaged in the process , and hence it is supportive overall of enhancing clinical practice . Interactive education can reduce barriers in guideline usage in daily practice",
"BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from \" fair \" to \" substantial , \" and the reliability of the total PEDro score was \" fair \" to \" good .",
"AIM The aim of this study is to examine the effects of an 8-day university-based training course , aim ed at identifying and addressing psychosocial prognostic factors during physiotherapy treatment , in shifting therapists towards a more biopsychosocial orientation as measured by changes in beliefs/attitudes , knowledge , skills and behaviour . METHOD We combined a r and omized controlled trail with a pre-post design . Forty-two physiotherapists applied for a university-accredited training course design ed to enhance knowledge and management of psychosocial factors in their practice with patients suffering from musculoskeletal pain . The course participants were r and omized either to receiving the course or to a waiting list for training . Attitudes and beliefs towards , and knowledge of psychosocial factors , patient vignettes and a video of an imaginary patient were tested before and after training . The patients of the course participants were asked to fill out a question naire with background questions at treatment start . The patients also received a question naire about the physical therapists ' behaviour and patient satisfaction 6 weeks after treatment start . RESULTS The results show that physical therapists ' attitudes and believes became more biopsychosocially and less biomedically orientated , they were less convinced that pain justifies disability and limitation of activities , and their knowledge and skills on psychosocial risk factors increased after a university-accredited training course . Yet despite these changes their patients perceived their practice behaviour before and after the course as similar and were equally satisfied with their treatment and treatment result . CONCLUSION A course , which enhanced biopsychosocial attitudes and beliefs , as well as increased such knowledge and skills did not change the way patients perceived their physical therapists . A future question is whether it improves patient outcome",
"Background and Purpose : Physical therapists often attend continuing education ( CE ) courses to improve their overall clinical performance and patient outcomes . However , evidence suggests that CE courses may not improve the outcomes for patients receiving physical therapy for the management of neck pain . The purpose of this study was to investigate the effectiveness of an ongoing educational intervention for improving the outcomes for patients with neck pain . Participants : The study participants were 19 physical therapists who attended a 2-day CE course focusing on the management of neck pain . All patients treated by the therapists in this study completed the Neck Disability Index ( NDI ) and a pain rating scale at the initial examination and at their final visit . Methods : Therapists from 11 clinics were invited to attend a 2-day CE course on the management of neck pain . After the CE course , the therapists were r and omly assigned to receive either ongoing education consisting of small group sessions and an educational outreach session or no further education . Clinical outcomes achieved by therapists who received ongoing education and therapists who did not were compared for both pretraining and posttraining periods . The effects of receiving ongoing education were examined by use of linear mixed-model analyses with time period and group as fixed factors ; improvements in disability and pain as dependent variables ; and age , sex , and the patient 's initial NDI and pain rating scores as covariates . Results : Patients treated by therapists who received ongoing education experienced significantly greater reductions in disability during the study period ( pretraining to posttraining ) than those treated by therapists who did not receive ongoing training ( mean difference=4.2 points ; 95 % confidence interval [CI]=0.69 , 7.7 ) . Changes in pain did not differ for patients treated by the 2 groups of therapists during the study period ( mean difference=0.47 point ; 95 % CI=−0.11 , 1.0 ) . Therapists in the ongoing education group also used fewer visits during the posttraining period ( mean difference=1.5 visits ; 95 % CI=0.81 , 2.3 ) . Discussion and Conclusion : The results of this study demonstrated that ongoing education for the management of neck pain was beneficial in reducing disability for patients with neck pain while reducing the number of physical therapy visits . However , changes in pain did not differ for patients treated by the 2 groups of therapists . Although it appears that a typical CE course does not improve the overall outcomes for patients treated by therapists attending that course , more research is needed to evaluate other educational strategies to determine the most clinical ly effective and cost-effective interventions",
"RATIONALE The concept of evidence -based medicine is important in providing efficient health care . The process uses research findings as the basis for clinical decision making . Evidence -based practice helps optimize current health care and enables the practitioners to be suitably accountable for the interventions they provide . Little work has been undertaken to examine how allied health professionals change their clinical practice in light of the latest evidence . The use of opinion leaders to disseminate new evidence around the management of low back pain into practice has been proposed . AIMS The aim of this study was to investigate if physiotherapists ' clinical management of patients with low back pain would change following an evidence -based education package , which utilized local opinion leaders and delivered the best evidence . METHOD Thirty musculoskeletal physiotherapists from a Community Trust in North Staffordshire were cluster r and omized by location of work , to two groups . The intervention group received an evidence -based programme on the management of low back pain , including advice regarding increasing activity levels and return to normal activity and challenging patients ' fears and beliefs about their pain . The control group received a st and ard in-service training package on the management of common knee pathologies . The physiotherapists ' clinical management of patients with low back pain was measured prior to training and 6 months post training . Outcome measures were based on physiotherapists completing ' discharge summary ' question naires , which included information relating to the use and importance of therapies for treating their low back pain patients . RESULTS There were few significant differences in treatment options between the intervention and control groups post training . Whilst there was some indication that physiotherapists were already utilizing aspects of psychosocial management for patients with low back pain , there was little change in what physiotherapists perceived to be important to patient recovery and actual clinical practice following the intervention . CONCLUSIONS Psychosocial factors have been identified as an important factor in the recovery of patients with low back pain . This project incorporated the latest evidence on the management of low back pain and utilized the theory of opinion leaders to disseminate this evidence into clinical practice . Whilst there were some limitations in the overall size of the study , the results help to give an insight into the challenges faced by the health care system and research ers alike to ensure quality evidence is actually utilized by practitioners for the benefits of patient care",
"OBJECTIVE To examine the effects of communication skills training on physiotherapists ' supportive behavior during clinical practice . DESIGN R and omized trial . SETTING Hospital outpatient physiotherapy clinics . PARTICIPANTS Physiotherapists ( N=24 ) and patients ( N=24 ) with chronic low back pain . INTERVENTIONS Two hospital clinics were r and omly assigned to the intervention arm . Physiotherapists ( n=12 ) received 8 hours of communication skills training focused on supporting patients ' psychological needs . Physiotherapists ( n=12 ) from 2 other hospital clinics formed a waitlist control arm . MAIN OUTCOME MEASURES Verbal communication between each physiotherapist and a patient was recorded on an audiotape , and independent , blinded raters used the Health Care Climate Question naire to assess physiotherapists ' needs-supportive behavior ( primary outcome ) . RESULTS Independent raters ' Health Care Climate Question naire scores favored the intervention arm ( Cohen 's d=2.27 ; P<.01 ) . CONCLUSIONS Compared with controls , independent ratings demonstrated that physiotherapists who completed the Communication style and exercise compliance in physiotherapy training were found to provide greater support for patients ' needs in a single assessed session . Long-term maintenance of this needs-supportive behavior should be examined",
"The seven articles in this issue , and the accompanying meta- analysis in Health Psychology Review [ McEachan , R.R.C. , Conner , M. , Taylor , N. , & Lawton , R.J. ( 2011 ) . Prospect i ve prediction of health-related behaviors with the theory of planned behavior : A meta- analysis . Health Psychology Review , 5 , 97–144 ] , illustrate the wide application of the theory of planned behaviour [ Ajzen , I. ( 1991 ) . The theory of planned behavior . Organizational Behavior and Human Decision Processes , 50 , 179–211 ] in the health domain . In this editorial , Ajzen reflects on some of the issues raised by the different authors . Among the topics addressed are the nature of intentions and the limits of predictive validity ; rationality , affect and emotions ; past behaviour and habit ; the prototype/willingness model ; and the role of such background factors as the big five personality traits and social comparison tendency",
"Background The effectiveness of risk stratification for low back pain ( LBP ) management has not been demonstrated in outpatient physical therapy setting s. Objective The purpose s of this study were : ( 1 ) to assess implementation of a stratified care approach for LBP management by evaluating short-term treatment effects and ( 2 ) to determine feasibility of conducting a larger-scale study . Design This was a 2-phase , preliminary study . Methods In phase 1 , clinicians were r and omly assigned to receive st and ard ( n=6 ) or stratified care ( n=6 ) training . Stratified care training included 8 hours of content focusing on psychologically informed practice . Changes in LBP attitudes and beliefs were assessed using the Pain Attitudes and Beliefs Scale for Physiotherapists ( PABS-PT ) and the Health Care Providers Pain and Impairment Relationship Scale ( HC-PAIRS ) . In phase 2 , clinicians receiving the stratified care training were instructed to incorporate those strategies in their practice and 4-week patient outcomes were collected using a numerical pain rating scale ( NPRS ) , and the Oswestry Disability Index ( ODI ) . Study feasibility was assessed to identify potential barriers for completion of a larger-scale study . Results In phase 1 , minimal changes were observed for PABS-PT and HC-PAIRS scores for st and ard care clinicians ( Cohen d=0.00–0.28 ) . Decreased biomedical ( −4.5±2.5 points , d=1.08 ) and increased biopsychosocial ( + 5.5±2.0 points , d=2.86 ) treatment orientations were observed for stratified care clinicians , with these changes sustained 6 months later on the PABS-PT . In phase 2 , patients receiving stratified care ( n=67 ) had greater between-group improvements in NPRS ( 0.8 points ; 95 % confidence interval=0.1 , 1.5 ; d=0.40 ) and ODI ( 8.9 % points ; 95 % confidence interval=4.1 , 13.6 ; d=0.76 ) scores compared with patients receiving st and ard physical therapy care ( n=33 ) . Limitations In phase 2 , treatment was not r and omly assigned , and therapist adherence to treatment recommendations was not monitored . This study was not adequately powered to conduct subgroup analyses . Conclusions In physical therapy setting s , biomedical orientation can be modified , and risk-stratified care for LBP can be effectively implemented . Findings from this study can be used for planning of larger studies"
] | 41163b8e-06ff-11f0-808a-c43d1ab1c353 |
Recurrent low back pain ( recurrent LBP ) is a common condition , however , it is unclear if uniform definitions are used in studies investigating the prevalence and management of this condition . The aim of this systematic review was to identify how recurrent LBP is defined in the literature . A literature search was performed on MEDLINE , EMBASE , CINAHL , AMED , and PEDro . Studies were considered eligible if they investigated a cohort of subjects with recurrent LBP or if they were measuring the prevalence of recurrent LBP . Two independent review ers assessed inclusion of studies and extracted definitions of recurrent LBP . Forty-three studies met the inclusion criteria . The majority of studies ( 63 % ) gave an explicit definition of recurrent LBP ; however , the definitions varied greatly and only three definitions for recurrent LBP were used by more than one study . The most common feature given as part of the definition was the frequency of previous episodes of low back pain . Only 8 % ( 3/36 ) of studies used previously recommended definitions for recurrent LBP . Large variation exists in definitions of recurrent LBP used in the literature , making interpretation of prevalence rates and treatment outcomes very difficult . Achieving consensus among experts in this area is required | [
"Objective To determine the effectiveness of lessons in the Alex and er technique , massage therapy , and advice from a doctor to take exercise ( exercise prescription ) along with nurse delivered behavioural counselling for patients with chronic or recurrent back pain . Design Factorial r and omised trial . Setting 64 general practice s in Engl and . Participants 579 patients with chronic or recurrent low back pain ; 144 were r and omised to normal care , 147 to massage , 144 to six Alex and er technique lessons , and 144 to 24 Alex and er technique lessons ; half of each of these groups were r and omised to exercise prescription . Interventions Normal care ( control ) , six sessions of massage , six or 24 lessons on the Alex and er technique , and prescription for exercise from a doctor with nurse delivered behavioural counselling . Main outcome measures Rol and Morris disability score ( number of activities impaired by pain ) and number of days in pain . Results Exercise and lessons in the Alex and er technique , but not massage , remained effective at one year ( compared with control Rol and disability score 8.1 : massage −0.58 , 95 % confidence interval −1.94 to 0.77 , six lessons −1.40 , −2.77 to −0.03 , 24 lessons −3.4 , −4.76 to −2.03 , and exercise −1.29 , −2.25 to −0.34 ) . Exercise after six lessons achieved 72 % of the effect of 24 lessons alone ( Rol and disability score −2.98 and −4.14 , respectively ) . Number of days with back pain in the past four weeks was lower after lessons ( compared with control median 21 days : 24 lessons −18 , six lessons −10 , massage −7 ) and quality of life improved significantly . No significant harms were reported . Conclusions One to one lessons in the Alex and er technique from registered teachers have long term benefits for patients with chronic back pain . Six lessons followed by exercise prescription were nearly as effective as 24 lessons . Trial registration National Research Register N0028108728 . How does the Alex and er Technique work ? What are the authors findings about the clinical and cost effectiveness of the treatment ? Watch this video to find out ( 12 mins ) .",
"BACKGROUND Chronic low-back pain is a significant public health problem for which few therapies are supported by predictable outcomes . In this report , practice activities and 1-month outcomes data are presented for 93 chiropractic patients and 45 medical patients with chronic , recurrent low-back pain . DESIGN A prospect i ve , observational , community-based feasibility study involving chiropractors and family medicine physicians . SETTING Forty private chiropractic clinics , the outpatient clinic of the Department of Family Medicine at Oregon Health Sciences University , and 5 other Portl and area family medicine clinics . OUTCOMES MEASURES The main outcome measures were pain severity , functional disability , sensory and affective pain quality at 1 month , and patient satisfaction assessed at 7 to 10 days and at 1 month . RESULTS Although differences were noted in age , sex , education , and employment , the patients were closely matched at baseline with respect to frequency , severity , and type of low-back pain and the psychosocial dimensions of general health . The treatment of choice for chiropractors was spinal manipulation and physical therapy modalities ; for medical physicians antiinflammatory agents were most frequently used . Chiropractic patients averaged 4 visits , and medical patients averaged 1 visit . On average , chiropractic patients showed improvement across all outcomes : 31 % change in pain severity , 29 % in functional disability , 36 % in sensory pain quality , and 57 % in affective pain quality . Medical patients showed minimal improvement in pain severity ( 6 % ) and functional disability ( 1 % ) and showed deterioration in the sensory ( 29 % ) and affective ( 26 % ) dimensions of pain quality . Satisfaction scores were higher for chiropractic patients . Outcomes for medical patients were heavily dependent on psychosocial status at baseline . CONCLUSION Patients with chronic low-back pain treated by chiropractors show greater improvement and satisfaction at 1 month than patients treated by family physicians . Non clinical factors may play an important role in patient progress . Findings from the Health Re sources and Services Administration-funded project will include a report on the influence of practice activities , including more frequent visits by chiropractic patients , on the clinical course of low-back pain and patient outcomes . ( J Manipulative Physiol Ther 2000;23:239 - 45 )",
"OBJECTIVES This study aim ed at determining the prognostic factors related to the recurrence of low-back pain and future sickness absence due to low-back pain . METHODS Data were used from a prospect i ve cohort study in a working population with a 3-year follow-up period . They were collected with annual question naires . A generalized estimating equation model was used to study the relation between pain characteristics , individual characteristics , and work-related factors and the recurrence of low-back pain or sickness absence due to low-back pain in the following year . Adjustments were made for potential confounders . RESULTS All the pain characteristics [ odds ratios ( OR ) varying from 1.4 to 2.4 ] , flexion and rotation of the upper part of the body [ OR 1.6 , 95 % confidence interval ( 95 % CI ) 1.1 - 2.5 ] , low decision authority ( OR 1.6 , 95 % CI 1.0 - 2.6 ) , and low job satisfaction ( OR 1.5 , 95 % CI 1.0 - 2.3 ) , increased the risk of recurrent low-back pain . High disability due to low-back pain ( OR 2.6 , 95 % CI 1.2 - 5.7 ) , low co-worker support ( OR 4.1 , 95 % CI 1.6 - 10.5 ) , and low job satisfaction ( OR 2.4 , 95 % CI 1.3 - 4.5 ) were predictors of sickness absence due to low-back pain . Lifting weights did not influence the risk of recurrences or sick leave . CONCLUSIONS According to this study , high disability due to low-back pain is a prognostic factor for recurrent low-back pain and future sickness absence due to low-back pain . In addition , the following work-related factors predict a poor prognosis of low-back pain : flexion or rotation of the trunk , low job satisfaction , low decision authority , and low social support",
"Study Design . Recruitment phase of a r and omized clinical trial . Objectives . To review the published literature on the use of the distress risk assessment method in different back pain population s and healthcare setting s and compare results with those obtained from the current trial . Summary of Background . Psychological distress in low back pain is commonplace , and distress increases the relative risk of poor outcome with physical treatment alone . The Distress and Risk Assessment Method is a tool for use in the clinical setting to assist in the identification of distress and clinical decision-making . Methods . The Distress Risk Assessment Method and Rol and Morris Disability Question naire were used to assess eligibility of patients with recurrent low back pain for recruitment into a r and omized clinical trial examining different physical therapy approaches . Results . In total , 221 patients were assessed , result ing in 212 correctly complete question naires . Of those 212 , 71 ( 33 % ) showed evidence of marked distress ( 41 depressed and 30 somatic ) . Functional disability , measured using the Rol and Morris Disability Question naire , was higher for the distressed group ( mean 14.1 , SD 4.8 , range 3–23 ) than the nondistressed group ( mean 8.0 , SD 5.1 , range 0–21 ) . Distress and anxiety measured using the distress risk assessment method were correlated to self-reported back-related functional disability . Conclusions . Distress associated with low back pain is common with one third of patients referred for physical therapy at the units studied exhibiting a level of distress that increased their relative risk of poor outcome by 3 to 4 times . Clinical ly , screening this group of patients may help indicate when liaison with other professionals is appropriate and possibly identify those patients who may be too distressed to respond to physical therapy intervention alone",
"& NA ; The purpose of the present study was to determine whether patients with recurrent low back pain display a different pattern of mood fluctuations across days than matched healthy controls and whether these mood states are related to pain occurrence and /or magnitude using a prospect i ve design . The questions addressed are whether mood states prior to a pain episode are associated with the episode or whether mood relates to pain as a secondary reaction . Similarly , the relationship between mood state recorded prior to , during or following pain and magnitude of pain experienced was investigated . Thirty‐three ambulatory chronic low pack pain patients and an equivalent group of asymptomatic controls matched for age , sex , socioeconomic status , and reported activity level monitored mood state ( anxiety , tension , depression , anger , vigor , fatigue , confusion ) and pain before breakfast , at 4 p.m. and at bedtime for 14 consecutive days . Groups were successfully matched . Analyses revealed significantly higher levels of tension , anxiety and fatigue and lower levels of vigor in the pain cases . No mood state was predictive of pain onset but fatigue was associated with pain 24 h following pain , indicating fatigue as secondary to pain . While mood state recorded prior to or following pain was unable to predict magnitude of pain , fatigue was associated with the level of pain experienced during the pain episode itself . The findings reveal a pattern of anxiety , tension and fatigue where fatigue is associated with increased pain during the pain episode and is increased 24 h following pain . This fatigue‐pain relationship is superimposed upon a continuous elevation of anxiety and tension . These findings suggest the importance of pain management efforts directed at decreasing patients ' fatigue levels , and increasing functional endurance while simultaneously reducing anxiety . The results also question the role of negative mood states in the initiation or exacerbation of pain and highlights the influence of physical mood states such as fatigue on pain in low back pain",
"Study Design . A prospect i ve cohort study . Objective . To study the relationship of sleep disturbances with severe back disorders leading to hospitalization . Summary of Background Data . Sleep disturbances are associated with persistent pain syndromes , but little is known about their relationship with back disorders . Methods . The first hospital admission for back disorders from 1973 to 2000 was studied in a cohort of metal industry workers ( n = 902 ) . The occurrence of sleep disturbances at baseline was categorized as : none ; 1 type ( either difficulties in falling asleep/waking up at night or nightmares ) ; or both types . Cox proportional hazards regression was used to estimate the time between the assessment of risk factors and first hospital admission for back disorders . Results . Those individuals who had 1 type of sleep disturbance had a 2.1-fold ( 95 % confidence interval 1.1−3.8 ) risk of back-related hospitalization , and those with both types of disturbance a 2.4-fold ( 1.2−4.6 ) risk , compared with those with no sleep disturbances . The hazard ratios were 2.1 ; 1.0−4.6 and 2.9 ; 1.2−7.1 , respectively , when patients with chronic back disease or recurrent back symptoms at baseline were excluded from the analyses . Conclusion . These findings suggest that sleep disturbances are predictive of hospitalization for back disorders . The mechanism underlying this association warrants further study",
"Study Design . A r and omized clinical trial with 1-year and 3-year telephone question naire follow-ups . Objective . To report a specific exercise intervention ’s long-term effects on recurrence rates in acute , first-episode low back pain patients . Summary of Background Data . The pain and disability associated with an initial episode of acute low back pain ( LBP ) is known to resolve spontaneously in the short-term in the majority of cases . However , the recurrence rate is high , and recurrent disabling episodes remain one of the most costly problems in LBP . A deficit in the multifidus muscle has been identified in acute LBP patients , and does not resolve spontaneously on resolution of painful symptoms and resumption of normal activity . Any relation between this deficit and recurrence rate was investigated in the long-term . Methods . Thirty-nine patients with acute , first-episode LBP were medically managed and r and omly allocated to either a control group or specific exercise group . Medical management included advice and use of medications . Intervention consisted of exercises aim ed at rehabilitating the multifidus in cocontraction with the transversus abdominis muscle . One year and three years after treatment , telephone question naires were conducted with patients . Results . Question naire results revealed that patients from the specific exercise group experienced fewer recurrences of LBP than patients from the control group . One year after treatment , specific exercise group recurrence was 30 % , and control group recurrence was 84 % ( P specific exercise group recurrence was 35 % , and control group recurrence was 75 % ( P specific exercise therapy in addition to medical management and resumption of normal activity may be more effective in reducing low back pain recurrences than medical management and normal activity alone",
"Effective pain relief and patient tolerance and acceptance are essential in outpatient management of mild to moderate pain of acute low back strain . This study evaluated the efficacy , tolerability , and acceptability of diflunisal and acetaminophen with codeine in patients with mild to moderate pain after an initial or recurrent acute low back strain . Both drugs demonstrated equipotent analgesic efficacy ; however , diflunisal was superior to acetaminophen with codeine for patient tolerability and acceptability . The results demonstrated that the study drugs were effective in treating mild to moderate pain caused by acute low back strain in an ambulatory care setting",
"OBJECTIVES To investigate the course of low back pain ( LBP ) in a general population over 5 years . DESIGN Prospect i ve population -based survey by postal question naires in 1991 , 1992 , and 1996 . SETTING The municipal of Ebeltoft , Denmark . SUBJECTS Two thous and people aged 30 to 50 years , representative of the Danish population . Main outcome measure Number of days with low back pain during the past year . RESULTS One thous and three hundred seventy were recruited of whom 813 ( 59 % ) were followed to 5 years . The responders could be divided into 3 groups with regard to LBP : no pain , short-term pain , and long-lasting/recurring pain . More than one third of people who experienced LBP in the previous year did so for > 30 days . Forty percent of people with LBP > 30 days at baseline remained in that group 1 and 5 years later , and 9 % with LBP > 30 days in year 0 were pain free in year 5 . People with LBP in year 0 were 4 times more likely to have LBP in year 1 , and 2 times more likely to be affected in year 5 . CONCLUSIONS Low back pain should not be considered transient and therefore neglected , since the condition rarely seems to be self-limiting but merely presents with periodic attacks and temporary remissions . On the other h and , chronicity as defined solely by the duration of symptoms should not be considered chronic",
"STUDY DESIGN A prospect i ve , r and omized , controlled trial with a stratification block design in which a Mensendieck exercise program was compared with the experience of a control group . OBJECTIVE To evaluate the effect of a Mensendieck program on the incidence of recurrent episodes of low back pain in patients with a history of the condition who currently are working . SUMMARY OF BACKGROUND DATA One episode of low back pain increases the risk of further episodes of the condition . The Mensendieck approach combines education and exercise . This approach has been used for many years in Sc and inavia and the Netherl and s. However , the effects on low back pain have not been evaluated previously in a r and omized , controlled trial . METHODS A total of 77 men and women , mean age 39.6 years ( range , 21.2 - 49.8 years ) , who had finished treatment for a low back pain episode , were stratified according to incidence of low back pain episodes and symptoms of sciatica over the preceding 3 years . The patients were assigned at r and om to either the Mensendieck program or a control group . The Mensendieck group received 20 group sessions of exercises and ergonomic education in 13 weeks . At 5- and 12-month follow-up examinations , the patients were assessed for recurrence of low back pain , days of sick leave , low back pain , and functional scores . RESULTS After 12 months , there was a significant reduction in recurrent low back pain episodes in the Mensendieck group compared with the control group ( P days of sick leave because of low back pain in the Mensendieck group , but no significant differences between the groups . There was reduction in pain and improvement in function in both groups , with no significant differences between the groups . CONCLUSIONS A secondary prophylaxis Mensendieck exercise program of 20 group sessions significantly reduced the incidence of low back pain recurrences in a population with history of the condition . However , there were no differences between the groups with regard to days of sick leave , low back pain , and function",
"Study Design . Prospect i ve cohort study . Objective . To identify the determinants for improvement in pain , functional limitations , and quality of life in low back pain ( LBP ) patients , and to evaluate whether return to work ( RTW ) can be predicted by these factors and associated improvement in health-related aspects . Summary of Background Data . It is unclear to what extent prognostic factors for the course of LBP and consequent functional limitations are similar to prognostic factors for RTW . Methods . A total of 103 LBP patients on sickness absence for 3 to 12 weeks filled out three question naires : at inclusion , and after 3 and 6 months . Information on the duration of sickness absence was gathered from occupational health services . Results . Different personal characteristics determined pain , functional limitations , and quality of life at baseline . These dimensions all improved over time , significantly during the first 3 months . Working at 3 months had a positive impact on all three dimensions . In the multivariate model , RTW was positively associated with male gender and recurrent LBP , whereas it was negatively associated with the level of functional limitations at baseline . Conclusion . Except for male gender , the primary determinants for improvement in pain , functional limitations , and quality of life were not associated with RTW . Although there is a large coherence in the improvement in the outcome measures , RTW seems primarily determined by the level of experienced functional limitations",
"& NA ; Association of health locus of control beliefs ( HLC ) and psychological distress ( GHQ‐12 ) with short‐term outcome of low‐back pain ( LBP ) rehabilitation was studied in patients with chronic or recurrent LBP ( n = 459 ; aged 35–54 years ; 63 % men ) . These patients were r and omly assigned to 3 study groups , namely the inpatient , the outpatient and the control group . The results showed a significant decrease in disability due to LBP in the 2 treated groups ; in addition , the accomplishment and frequency of back exercises was significantly better in the treated groups . HLC beliefs were associated with a successful outcome ; those patients with stronger internal beliefs had gained more from the treatment , had learned their exercises better and had done the exercises more frequently during the follow‐up period . Symptoms of psychological distress were significantly associated with poorer accomplishment of back exercises",
"Many clinical trials on chiropractic management of low back pain have neglected to include specific forms of care . This study compared two well-defined treatment protocol s. The objective was to compare the outcome of flexion – distraction ( FD ) procedures performed by chiropractors with an active trunk exercise protocol ( ATEP ) performed by physical therapists . A r and omized clinical trial study design was used . Subjects , 18 years of age and older , with a primary complaint of low back pain ( > 3 months ) were recruited . A 100 mm visual analogue scale ( VAS ) for perceived pain , the Rol and Morris ( RM ) Question naire for low back function , and the SF-36 for overall health status served as primary outcome measures . Subjects were r and omly allocated to receive either FD or ATEP . The FD intervention consisted of the application of flexion and traction applied to specific regions in the low back , with the aid of a specially design ed manipulation table . The ATEP intervention included stabilizing and flexibility exercises , the use of modalities , and cardiovascular training . A total of 235 subjects met the inclusion /exclusion criteria and signed the informed consent . Of these , 123 were r and omly allocated to FD and 112 to the ATEP . Study patients perceived significantly less pain and better function after intervention , regardless of which group they were allocated to ( P flexion – distraction group had significantly greater relief from pain than those allocated to the exercise program ( P=0.01 ) . Subgroup analysis indicated that subjects categorized as chronic , with moderate to severe symptoms , improved most with the flexion – distraction protocol . Subjects categorized with recurrent pain and moderate to severe symptoms improved most with the exercise program . Patients with radiculopathy did significantly better with FD . There were no significant differences between groups on the Rol and Morris and SF-36 outcome measures . Overall , flexion – distraction provided more pain relief than active exercise ; however , these results varied based on stratification of patients with and without radiculopathy and with and without recurrent symptoms . The subgroup analysis provides a possible explanation for contrasting results among r and omized clinical trials of chronic low back pain treatments and these results also provide guidance for future work in the treatment of chronic low back pain",
"STUDY DESIGN A prospect i ve 9-year follow-up study involving r and omized matched subgroups of 15-year-old schoolchildren with or without low back pain at baseline . OBJECTIVES To evaluate the long-term persistence of initially reported recurrent low back pain , and to examine the significance of abnormalities found in magnetic resonance imaging of lumbar discs in individuals 15 and 18 years of age as possible contributors to persistently recurrent low back pain . SUMMARY OF BACKGROUND DATA In surveys among children and teenagers during the past few years , as many as half of all children in a community report a history of low back pain . The current results , in accordance with previous findings , indicate that there is a subgroup of adolescents with more chronic symptoms which , in the authors ' opinion , deserves more attention . Disc disease accompanying low back pain is a key issue both in research and clinical practice . The significance of early degenerative findings in the lumbar discs is not known . METHODS In the survey of 14-year-olds ( n = 1503 ) , a subgroup ( 7.8 % ) with recurrent low back pain was found . A r and om sample of individuals with recurrent low back pain ( n = 40 ) and an equal number of completely asymptomatic control subjects were selected for a comparative study . The selected groups were examined by magnetic resonance imaging at 15 and 18 years of age . The participation rate of youth at 14 , 18 , and 23 years of age for all three question naires was 82 % ( 29 boys and 33 girls ) . Imaging data were interpreted by two blinded radiologists experienced in low-field-strength magnetic resonance imaging . In calculations of relative risks , the participants reporting recurrent low back pain in all phases of the study were compared with participants who had no persistently recurrent pain . RESULTS Eleven participants ( 35 % ) in the original group with low back pain persistently reported recurrent pain . In 15-year-old participants with disc degeneration , the relative risk of reporting recurrent low back pain up to the age of 23 years was 16 ( 95 % confidence interval 2.2 - 118 ) compared with those having no disc degeneration . In addition , disc protrusion and Scheuermann-type changes at 15 years contributed to the risk of persistently recurrent low back pain . CONCLUSIONS The authors ' earlier findings already favored the hypothesis of a causal relation between the early evolution of a degenerative process of lower lumbar discs and recurrent low back pain in the near future . The current results further strengthen this hypothesis , indicating that individuals with disc degeneration soon after the phase of rapid physical growth not only have an increased risk of recurrent low back pain at this age , but also a long-term risk of recurrent pain up to early adulthood",
"Study Design . Prospect i ve , r and omized trial . Objectives . To compare the McKenzie method of treatment of acute low back pain with patient education in “ mini back school ” after 5 years ; the 1-year results have already been published . Summary of Background Data . The 5-year results after the initial treatment are presented in this study of 89 subjects . Included in the study were 22 women and 67 men with an average age of 39.6 ± 10.5 years ( range 22–66 years ) . Methods . Sixty-two subjects ( 70 % ) were interviewed by telephone , while the remaining 27 subjects ( 30 % ) were examined and interviewed personally . Information of sick leave was obtained from the Swedish National Health Insurance Office . Results . The results showed that subjects who received treatment according to the McKenzie principle 5 years earlier had significantly less recurrences of pain and fewer were on sick leave compared with the subjects who received education in mini back school . The other variables did not show any statistically significant differences . Conclusions . The difference between the two treatments was much less after 5 years compared with the 1-year results",
"AIM Physical therapy efficacy in the treatment of low back pain ( LBP ) has been widely debated and is far from achieving high levels of evidence . Hydroelectrophoresis ( Hydrofor ) is a novel method of driving drugs through the dermal tissue , which has been proposed for muscle pain treatment . Aim of this r and omised placebo-controlled study was to ascertain the efficacy of Hydrofor treatment on acute relapsing episodes of pain in chronic LBP subjects . METHODS Eighteen under-50 adults ( M/F : 7/11 ; age 35+/-8 years ) suffering from chronic LBP were enrolled within 3 to 4 days of back pain relapse . After a complete clinical and functional assessment patients were r and omly divided into 2 equal groups . Group A received 3 Hydrofor applications of a mixture containing both NSAIDs and muscle relaxants , whereas Group B received 3 Hydrofor applications of a drug-free solution . Afterwards , both groups performed the same rehabilitation treatment consisting of 7 group sessions of st and ard physiotherapy , including stretching , range of motion and extension exercises . The Oswestry disability index ( ODI ) , the Million instrument scale and a visual analogue scale ( VAS ) were chosen as outcome measures and applied at baseline , after Hydrofor/placebo applications , after completion of rehabilitation sessions and , at last , 2 months later . The two-way Friedman test was used to analyse within-group ( time effect ) and between-group ( time x group effect ) differences . RESULTS All subjects declared a significant pain reduction since the first Hydrofor application . Pain evolution overlapped in the 2 groups until the 3rd session , after which Group A significantly diverged from Group B , as they affirmed a greater symptom reduction than controls ( time x group effect : VAS : F = 7.4 , p Pain-related disability showed a greater reduction in Group A than B immediately after Hydrofor application ( time x group effect : ODI : F=3.9 p Hydrofor treatment relieves relapsing LBP and could be recommended to active adults as a safe technique shortening the time needed to achieve functional restoration",
"BACKGROUND Surveys with a main focus on back pain tend to isolate the complaint from possibly concomitant pains , other symptoms and disorders . Severe chronic back pain is assumed here to imply more than pain in the back . PARTICIPANTS AND METHODS We report results from a two stage survey conducted in 1998 - 2000 . The initial postal question naire addressed all 10,000 actively employed blue collar workers from a regional pension fund ( L and esversicherungsanstalt Schleswig-Holstein ) aged 40 - 54 and residing in or around Luebeck/Germany ( 68 % males ) . Subjects reporting severe and disabling back pain were invited to a socio-medical examination . The response and participation rates were 58 % and 65 % respectively . Non-response and non-participation seem to result in minor though opposite , effects . RESULTS The prevalence of current back pain ( back pain of any severity within the past 7 days ) is high ( 68 % ; including 16 % with severe , disabling back pain ) despite the preponderance of males and a probable healthy worker effect . 82 % of subjects participating in the second round reported recurrent or persisting back pain on the day of examination , in the majority with a chronic fluctuating and overall deteriorating course pattern . 18 % reported no current back pain and hence gave prospect i ve ( and additionally retrospective ) evidence of an episodic-intermittent course of the disorder . The former group showed significantly more pains , bodily complaints , dysfunctional cognitions , emotional distress and concomitant disorders . 35 % of them indicated back pain as their dominant health problem ; 49 % identified back pain and another disorder as dominant , and 16 % reported other prominent health problems . More than 70 % of \" other \" disorders originated from the musculoskeletal system often involving the extremities . SUMMARY AND CONCLUSION Back pain is very common among blue collar workers . Severe disabling back pain is usually associated with numerous other pains , bodily complaints , disorders , and indicators of psychological distress ( \" amplified back pain \" ) . However , even amplified back pain is not always the sole or dominant health problem . Assessing the degree of \" amplification \" seems helpful in splitting a previously homogeneous group of severely affected back pain sufferers-with possible prognostic and therapeutic consequences",
"BACKGROUND Determination of the mode of action of new exercise techniques in different back pain population s is lacking . The effectiveness of supplementing an exercise programme with stabilisation exercises concerning physiological and functional parameters in non-specific back pain patients is unknown . METHODS R and omised controlled trial , comparing a general trunk muscle endurance exercise approach enhanced with specific muscle stabilisation exercises ( S&G group ) with a general exercise approach only ( G group ) . 55 patients with recurrent back pain were r and omised in S&G group ( n=29 ) and G group ( n=26 ) . Both groups received an 8-week exercise intervention and written advice . Paraspinal muscle strength and electromyographic fatigue of the erector spinae and multifidus were measured . Additionally , 3 functional speed tests were assessed . Outcomes were collected pre- and post-intervention . FINDINGS No differences were detected for any of the paraspinal fatigue characteristics either within or between groups , apart from a significant decrease in normalised median frequency slope of the erector spinae for the G group . Paraspinal muscle strength and all functional tests have demonstrated significant within-group improvements for both groups , without any between-group differences . INTERPRETATION An 8-week stabilisation exercise-enhanced approach presented equal benefits to a general endurance-based exercise programme for patients with recurrent non-specific back pain . A slightly steeper slope for the erector spinae in the G group was the only electromyographic fatigue alteration noted . Concomitant strength improvement probably reflects neural input changes rather than histochemical muscle changes . Physical exercise alone and not the exercise type was the key determinant for improvement in this patient group",
"& NA ; Given the dem and for interventions that may prevent the development of persistent musculoskeletal pain problems , we investigated the effects of a cognitive‐behavioral program in a group of non‐ patients with neck or back pain symptoms . Two hundred and fifty‐three people selected from a population study were invited to participate . These people had experienced four or more episodes of relatively intense spinal pain during the past year but had not been out of work more than 30 days . Participants were r and omly assigned to either a cognitive‐behavioral group intervention or a treatment as usual comparison group . The experimental group received a st and ardized six‐session program , provided by a trained therapist according to a manual . A significant overall analysis at the 1‐year follow‐up showed that the cognitive‐behavioral group produced better results on 26 of the 33 outcome variables . Group comparisons indicated that the cognitive‐behavioral group , relative to the comparison group , had significantly better results with regard to fear‐avoidance beliefs , number of pain‐free days , as well as the key variable of sick leave . Participation in the cognitive behavioral group reduced the risk for long‐term sick leave during the follow‐up by threefold . Thus , despite the strong natural recovery rate for back pain , the cognitive‐behavioral intervention produced a significant preventive effect with regard to disability",
"OBJECTIVE The purpose was to examine whether or not participation in an e-mail discussion group would affect use of selected complementary and alternative medicine ( CAM ) modalities during an Internet-based , 1-year r and omized , controlled trial on back pain management . METHODS Intervention subjects ( n = 190 ) participated in a closed , moderated e-mail discussion group ; control subjects ( n = 231 ) received usual care . At 1 year , we compared CAM use over the previous 6-month period during which intervention subjects had had interactive discussion s about them . Differences in CAM use between groups were compared using Chi-square and t-tests . RESULTS Subjects did not differ statistically between groups ( p > 0.05 ) . They were Caucasian ( approximately 91 % ) , male ( approximately 60 % ) , in their mid-40s , well educated , had approximately 13 years back pain duration , a disability level approximately 10 ( Rol and -Morris scale : 0 - 23 ; 23 = worst ) , and > 80 % had used the Internet for greater than a year before the r and omized trial . During the study period , only small proportions in either group had initiated use of glucosamine ( 13 % versus 8 % ) , chiropractic services ( 5 % versus 4 % ) , acupuncture ( 3 % , both ) , yoga ( 6 % versus 4 % ) , or magnets ( 6 % , both ) . CONCLUSION Results suggest that participation in interactive discussion s over the Internet about these CAM modalities may not affect their use",
"OBJECTIVES This 1-year prospect i ve study aim ed at assessing the association between some psychosocial job characteristics and back-related functional limitations . METHODS The participants were 849 workers who sought medical consultation for nonspecific back pain in primary care setting s of the Quebec City area . Information on job decision latitude , psychological dem and s , and social support at work was collected during a telephone interview conducted after the medical consultation . Back-related functional limitations were measured at baseline and 1 year later with the Rol and -Morris Disability Question naire . The analyses were stratified by gender . Social support at work and the type of back pain were considered potential effect modifiers . Several potential confounders were also considered in the multiple regression analyses that were conducted to isolate the effect of the job psychological dem and s and decision latitude on the 1-year level of back-related functional limitations . RESULTS A modest difference in the 1-year Rol and -Morris average scores was found only among the women and only for the association between job decision latitude with back-related functional limitations , according to the level of social support at work . This difference was of limited clinical significance . Analyses by type of back pain showed , however , a clinical ly significant association between the combination of high psychological dem and s and low decision latitude and back-related functional limitations only for subjects with persistent pain . CONCLUSIONS Job psychological dem and s and decision latitude have little influence on the 1-year evolution of back-related functional limitations for one-time and recurrent back-pain problems . However , our results suggest that this association could be important for workers with persistent pain",
"The purpose of this study was to compare the effect of the McKenzie method of treatment with patient education in “ mini back school ” in patients with acute low-back pain . The study included 100 patients , 23 women and 77 men with the average age 34.4 ± 9.7 ( range 18 - 61 ) years . The study included only those who were employed . The patients were r and omly allocated to two groups , one group receiving treatment according to the McKenzie technique and the other group receiving education in a “ mini back school . ” Assessment s were made after 3 weeks by an independent observer and after 52 weeks they were seen by one of the authors . Patients were assessed on seven variables : return to work , sick-leave during the initial episode , sick-leave during recurrences , recurrences of pain during the year of observation , patients ' ability to self-help , pain and movement . Although the effect of attention placebo can not be ruled out , the results demonstrated that the McKenzie method of treatment for patients with acute low-back pain was superior for five out of seven variables studied . The only variables that did not show any statistically significant differences were sick-leave during recurring episodes of pain and patients ' ability to self-help",
"BACKGROUND AND PURPOSE Exercise and education is a common physiotherapy approach in the prevention of low back pain . A Mensendieck exercise programme consisting of exercises and ergonomical education has , in a previous study , been shown to be effective in preventing recurrent low back pain during one-year follow-up . The purpose of the present study was to evaluate the long-term effect of the Mensendieck exercise programme on people with recurrent episodes of low back pain who , when entering the study , had finished treatment for their last episode of low back pain . METHOD A r and omized controlled clinical trial in which 41 women and 36 men were allocated to either a Mensendieck or control group . The Mensendieck subjects received 20 group sessions of exercises and ergonomical education over 13 weeks . The control subjects were not offered any prophylactic therapy , but were free to receive treatment or exercises . Outcome measures were the number of recurrences of low back pain , sick leave , low back function and general functional status . RESULTS At three-year follow-up , 11 subjects had been lost to the study . Survival analysis showed a significant reduction ( p = 0.02 ) in subjects experiencing recurrent low back pain in the Mensendieck group compared to the control group . Significant improvements in pain and function scores were reported in both groups . There was no significant difference between the groups in pain , function or sick leave . CONCLUSION A Mensendieck exercise programme seems efficient in reducing recurrent episodes of low back pain at three-year follow-up , but it did not influence sick leave , pain or function scores",
"Context Lumbar supports are commonly used to prevent low back pain , but evidence on their effectiveness is lacking . Contribution This trial assigned 360 home care workers with a history of low back pain to a short course on healthy work habits , with or without worker-directed use of a lumbar support . Over 12 months , participants assigned to lumbar support had a similar number of sick days but fewer days with low back pain than did those assigned to the course only . Implication Adding lumbar supports to instruction on healthy work habits may decrease low back pain recurrence , but not absenteeism , among workers with previous low back pain . The Editors Low back pain is a common problem that results in high medical expenses , work absenteeism , and disability ( 1 ) . The reported 1-year prevalence ranges from 15 % to 40 % in a general population ( 2 ) and from 44 % to 72 % among home care workers ( 3 , 4 ) . Various ergonomic aids are marketed for the prevention of low back pain . Workers frequently use lumbar supports to prevent back pain ( 5 ) , but the effectiveness of such supports remains unclear . Recent systematic review s of the sparse evidence on lumbar supports ( 6 , 7 ) concluded that no evidence exists for the effectiveness of lumbar supports in the primary prevention of low back pain in the workplace , but 2 of the 4 included r and omized , controlled trials ( 8 , 9 ) reported that lumbar supports might be effective in workers with a history of low back pain ( secondary prevention ) . However , these findings were derived from subgroup analyses , and evidence from direct research on secondary prevention was not available . In cohort studies , a history of low back pain proved to be a strong predictor for the incidence of new episodes of low back pain ( 1012 ) . Home care workers with a history of low back pain may therefore be well suited to secondary preventive measures . In a previous uncontrolled feasibility study , we found that home care workers who had frequent episodes of low back pain reported adherence rates of 61 % to 81 % with lumbar supports and a 45 % decrease in pain intensity when using lumbar supports ( 13 ) . We design ed the current trial to evaluate the effectiveness of adding worker-directed use of lumbar supports to a short course on healthy working methods to reduce low back pain and work absenteeism among home care workers with a history of low back pain . Methods Design Our r and omized , controlled trial included 2 groups . The control group received a short refresher course on healthy working methods provided by their employer at the start of their employment ( Appendix ) ; primary and secondary care for the management of low back pain was available as usual ( 14 ) . The intervention group received a lumbar support in addition to usual care . The intervention and data collection continued for 12 months after enrollment . The Medical Ethical Committee of the Erasmus University Medical Center , Rotterdam , the Netherl and s , approved the study . Participants All participants were recruited from employees of a large home care organization in Rotterdam . During staff meetings , all present team members completed a brief survey about study inclusion criteria that was distributed and collected by the team managers . We included persons who performed medical care or domestic tasks as a home care worker , were experiencing low back pain symptoms at the time of inquiry or had experienced 2 or more episodes ( on 2 consecutive days ) of low back pain symptoms in the 12 months before the inquiry , did not have specific low back pain ( for example , due to rheumatoid arthritis or vertebral fractures ) , and were not pregnant at the start of the study . Because of a possible association between lumbar supports and increased blood pressure and heart rate , we excluded workers receiving medical treatment for high blood pressure ( 15 ) . Employees who met the inclusion criteria received detailed information about the trial , and those who agreed to participate provided written consent . R and omization In the Netherl and s , home care workers provide 1 of 8 functions , each of which requires different skills and tasks . To ensure a balance in workload and working conditions between the 2 study groups , we stratified r and omization by these 8 functions . We also stratified r and omization by low back pain experience at baseline ( current pain vs. past pain ) . The r and omization process used a computer-generated r and om-number table with 16 strata ( 2 low back pain by 8 workplace functions ) , arranged in blocks of 8 within each stratum . After baseline measurements were completed , colleagues who were not otherwise involved in the study and who were blinded to participants ' baseline characteristics used the r and om-number table to allocate each participant to 1 of the study groups . Intervention All participants in the intervention group were instructed to wear the lumbar supports on working days on which they had or expected they might develop low back pain . Participants could select 1 of 4 types of lumbar supports , supplied by Bauerfeind B.V. , Haarlem , the Netherl and s. LumboTrain and LumboTrain Lady are individually adjustable , hook- and -loop fastening , fully elastic supports that are available in 5 sizes for men or women . LumboLoc and LordoLoc are more structured supports , with integrated stays in the back , that have individually adjustable hook- and -loop fastenings and are available in 6 sizes . Participants chose the lumbar support on the basis of fit and wearing comfort , and they were not given advice to direct their choice from among the 4 available supports . When measured by the research er for the lumbar support , the participants were advised to wear the support for a few days in a row , regardless of low back pain , in order to become accustomed to it . The expected duration of wearability of the lumbar supports was 1 year . The costs of the lumbar supports were 75 for LumboTrain and LumboTrain Lady , 56 for LumboLoc , and 50 for LordoLoc . Outcome Measures Our primary outcome measures were the number of days that participants reported low back pain per month and the number of calendar days of sick leave that participants took during the 12-month intervention . Secondary outcome measures were the average severity of low back pain in the previous week , rated on a scale of 0 to 10 ( 16 ) , and functional status in the previous week , measured by using a Dutch translation of the Quebec Back Pain Disability Scale ( on which 0 corresponds to no disablement and 100 corresponds to fully disabled ) ( 17 , 18 ) . Participants used a calendar to record the days per month on which they experienced low back pain . The intervention group was also asked to record on the calendar whether they had worn the lumbar support ; thus , the calendars also served as a monitor for adherence to therapy . The calendars were collected for review after 1 , 3 , 6 , 9 , and 12 months . The number of calendar days of sick leave was derived from the staff register and was provided by the home care organization at the end of the study ; this information covered 15 months , from 3 months before the start of the study until the end of the intervention . We could gather only general data on sick leave because employees are not obliged to specify their illness for the employer when they report themselves ill , and registration by a company doctor starts from 6 consecutive weeks of sick leave . We collected information on self-reported , low back painrelated sick leave ; however , this was not a predetermined outcome , and the results should be interpreted cautiously . We administered a question naire at baseline to obtain information on the secondary outcome measures and demographic characteristics ; history of low back pain ; job characteristics ( among others , the Job Content Question naire , Dutch translation [ 19 ] ) ; and other possible confounders , such as additional work ( hours per week and type ) , preference for study group assignment , confidence in pain reduction with use of the lumbar support ( scale of 0 to 10 ) , and confidence in improved functioning ( scale of 0 to 10 ) . Follow-up question naires were administered at 3 , 6 , 9 , and 12 months to measure the secondary outcomes . In the intervention group , these question naires also measured the general satisfaction with the lumbar support ( scale of 0 to 10 ) , several items on comfort of wearing ( 5-point Likert scale ) , and adherence to use of the lumbar support ( 7-point Likert scale ) . We recorded spontaneously reported side events and asked participants about side effects in the question naires . Statistical Analysis We estimated that with a power of 80 % , a significance level of 0.05 , and an SD of 20 days , we would need 140 participants in each study group to demonstrate a difference of 7 days of low back pain per year or sick leave per year between the 2 groups . To prevent inadequate power because of participant withdrawal or low adherence to therapy , we sought to enroll 400 home health care workers . We used a longitudinal marginal model with generalized estimating equation estimates to analyze the data , according to intention-to-treat principles . For the primary outcomes ( number of days of low back pain and number of days of sick leave ) , we used a negative-binomial count data model with a log-link and an exchangeable correlation structure . Covariates ( history of low back pain , body mass index , additional work , and pregnancy during follow-up ) were added to the model separately and were used in the final model if they statistically significantly contributed to the model ( P < 0.05 ) . The scale scores of the secondary outcomes were analyzed by using a normal distributed model and an exchangeable correlation structure . To investigate model misspecification and the effect of missing data , we performed sensitivity analyses in which we used various structures for the working correlation to estimate the models and used multiple imputation techniques to analyze 5 imputed data sets for missing data ( 20 ) . For all analyses , we used SAS ,",
"The purpose of the present study was to investigate the long-term effect of the Active Back School programme on minimizing recurrences of episodes of low back pain . Forty-three subjects were r and omly allocated to the Active Back School group and 38 to the control group . There were no significant differences between the groups with regard to baseline characteristics . The Active Back School programme comprised 20 lessons each divided into a 20-min theoretical and a 40-min exercise part during a 13-week period . Nine participants ( 11 % ) dropped out during the study period . Recurrence of new low back pain episodes was significantly less ( p = 0.04 ) , and the time from inclusion to the first new low back pain episode was significantly on the side of the Active Back School group ( p duration of sick leave was found to be significantly shorter ( p Active Back School group compared to the control group . The Active Back School reduced the recurrence and severity of new low back pain episodes at 36 months ' follow-up",
"OBJECTIVE To explore the relationship between type of initial care as well as the likelihood of recurrence and consequent care seeking behavior . RESEARCH DESIGN Prospect i ve observational cohort recruited from 208 r and omly selected North Carolina practice s. Cohort study examined the recurrence of low back pain among patients free of back pain 3 months after their index visit to a practitioner for that problem . The following four practitioner strata were examined : primary care providers , chiropractors , orthopedic surgeons , and practitioners in a group model HMO . Patients were interviewed by telephone at 6 and 22 months after the initial visit . MAIN OUTCOME MEASURES Rates of disabling and non-disabling low back pain ; functional status using the Rol and back disability scale ; and care seeking . RESULTS Rates of recurrence were substantial ; functionally disabling recurrence rates varied between 8 % and 14 % between 3 to 6 months , and 20 % to 35 % between 6 to 22 months . Differences in rates among practitioner strata were statistically significant only between 6 to 22 months with higher recurrence rates for HMO patients . Functional status , number of bed days , and time off work were very similar among the practitioner strata . Care seeking , however , was greater among those patients who had initially seen a chiropractor for their back pain . Patients with recurrence saw the same practitioner type they had seen for the index episode 88 % of the time . Satisfaction was slightly greater for patients who saw chiropractors when compared with patients seeing allopathic physicians . CONCLUSIONS The recurrence of low back pain is common . Severe disability is rare . Patients who had sought care from chiropractors are more likely to return for recurrences than patients who had initially sought care from MDs",
"OBJECTIVE To investigate the recovery pattern in chiropractic patients being treated for long-lasting or recurrent low back pain ; in particular , to identify the minimum number of required treatments and the minimum number of days from the beginning of treatment to the occurrence of improvement . DESIGN Prospect i ve , uncontrolled multicenter study . SETTING Private practice . PARTICIPANTS Each of 19 selected Norwegian chiropractors provided 10 consecutive patients ; each of the latter fulfilled a set of criteria ( low back pain , a present episode longer than 2 weeks in duration , a total of more than 4 weeks of low back pain in the preceding year , no chiropractic treatment during the preceding 6 months , and suitability for manipulation ) . Response Rate : Data were collected on 164 patients ( 86 % of the optimal study sample ) , 6 of whom were excluded . This left 158 patients for the analyses . MAIN OUTCOME MEASURES Information on low back pain status was collected on each visit ( maximum , 12 visits ) through use of both a 10-point numeric pain rating scale and a global improvement scale ( for the question \" Do you feel that you have improved since you began receiving chiropractic treatment ? , \" 5 answers were possible , ranging from \" Yes , definite improvement \" to \" No , I am worse now than when the treatment started \" ) . With respect to the numeric pain rating scale , \" improvement \" was defined as the point at which the score reached 2 for the first time or , if the initial score was 2 , the point at which the score reached 1 for the first time . With respect to the global improvement scale , \" improvement \" was defined as the point at which the patient first answered \" Yes , definite improvement . \" RESULTS Approximately 50 % of patients reported that they had \" improved \" at the 4th visit and within 2 weeks . After this time , fewer new cases of \" improvement \" occurred for every visit or day since the first treatment . At the 12th visit ( earlier if treatment was concluded before the 12th visit ) , approximately 75 % of the patients reported that \" improvement \" had occurred . CONCLUSION There is a large group of chiropractic patients with relatively long-lasting or recurrent low back pain who report \" improvement \" early in the course of treatment",
"A systematic review of r and omised controlled trials was undertaken to evaluate the effectiveness of workplace interventions to prevent low back pain . Potential trials were located by a computerised search supplemented with citation tracking . The method ological quality of the trials was assessed on 11 criteria and the level of evidence for each intervention was determined , based upon the amount , consistency and quality of evidence from the trials . The review located 13 trials that were generally of moderate quality . The trials suggest that work place exercise is effective , braces and education are ineffective , and workplace modification plus education is of unknown value in preventing low back pain",
"BACKGROUND AND PURPOSE The purpose of this r and omized controlled trial was to examine the usefulness of the addition of specific stabilization exercises to a general back and abdominal muscle exercise approach for patients with subacute or chronic nonspecific back pain by comparing a specific muscle stabilization-enhanced general exercise approach with a general exercise-only approach . SUBJECTS Fifty-five patients with recurrent , nonspecific back pain ( stabilization-enhanced exercise group : n=29 , general exercise-only group : n=26 ) and no clinical signs suggesting spinal instability were recruited . METHODS Both groups received an 8-week exercise intervention and written advice ( The Back Book ) . Outcome was based on self-reported pain ( Short-Form McGill Pain Question naire ) , disability ( Rol and -Morris Disability Question naire ) , and cognitive status ( Pain Self-Efficacy Question naire , Tampa Scale of Kinesiophobia , Pain Locus of Control Scale ) measured immediately before and after intervention and 3 months after the end of the intervention period . RESULTS Outcome measures for both groups improved . Furthermore , self-reported disability improved more in the general exercise-only group immediately after intervention but not at the 3-month follow-up . There were generally no differences between the 2 exercise approaches for any of the other outcomes . DISCUSSION AND CONCLUSION A general exercise program reduced disability in the short term to a greater extent than a stabilization-enhanced exercise approach in patients with recurrent nonspecific low back pain . Stabilization exercises do not appear to provide additional benefit to patients with subacute or chronic low back pain who have no clinical signs suggesting the presence of spinal instability",
"This study evaluated the efficacy of an exercise programme as an intervention for recurrent non-specific low-back pain ( NLSBP ) in adolescents . A r and omized controlled trial was conducted with an experimental group ( n = 27 , age 14.6 years ) who participated in an 8-week exercise programme and a matched control group ( n = 27 , age 14.6 years ) who continued normal daily activities . All participants suffered from recurrent NSLBP . Pre and post intervention measures of NSLBP status ( pain severity and consequences ) and daily inactivity ( time spent sitting , PC time , TV time ) were reported in one week diaries . Two-way mixed ANOVA ( independent variables : pre/post and experimental/control ) was conducted for each dependent variable , significance was set at P severity of pain , number of occasions missing sport due to NSLBP and amount of sport participated in . In each case the experimental group benefited from the exercise programme . In contrast , no significant interaction effects were observed for physical inactivity , both groups spent a similar amount of time sitting , watching TV and using a PC pre- and post- intervention . It was concluded that an exercise programme acted as an effective short-term treatment strategy for NSLBP in adolescents . Further evaluation is required to assess the long-term effectiveness",
"Study Design . Pragmatic , multicentered r and omized controlled trial , with 12-month follow-up . Objective . To evaluate the effect of adding specific spinal stabilization exercises to conventional physiotherapy for patients with recurrent low back pain ( LBP ) in the United Kingdom . Summary of Background Data . Spinal stabilization exercises are a popular form of physiotherapy management for LBP , and previous small-scale studies on specific LBP subgroups have identified improvement in outcomes as a result . Methods . A total of 97 patients ( 18–60 years old ) with recurrent LBP were recruited . Stratified r and omization was undertaken into 2 groups : “ conventional , ” physiotherapy consisting of general active exercise and manual therapy ; and conventional physiotherapy plus specific spinal stabilization exercises . Stratifying variables used were laterality of symptoms , duration of symptoms , and Rol and Morris Disability Question naire score at baseline . Both groups received The Back Book , by Rol and et al. Back-specific functional disability ( Rol and Morris Disability Question naire ) at 12 months was the primary outcome . Pain , quality of life , and psychologic measures were also collected at 6 and 12 months . Analysis was by intention to treat . Results . A total of 68 patients ( 70 % ) provided 12-month follow-up data . Both groups showed improved physical functioning , reduced pain intensity , and an improvement in the physical component of quality of life . Mean change in physical functioning , measured by the Rol and Morris Disability Question naire , was −5.1 ( 95 % confidence interval −6.3 to −3.9 ) for the specific spinal stabilization exercises group and −5.4 ( 95 % confidence interval −6.5 to −4.2 ) for the conventional physiotherapy group . No statistically significant differences between the 2 groups were shown for any of the outcomes measured , at any time . Conclusions . Patients with LBP had improvement with both treatment packages to a similar degree . There was no additional benefit of adding specific spinal stabilization exercises to a conventional physiotherapy package for patients with recurrent LBP",
"The purpose of this study was to evaluate the efficacy of a specific 8-week exercise rehabilitation program as an intervention to treat recurrent nonspecific low back pain in adolescents . A r and omized controlled trial involving 54 adolescents ( 14.6 + /- 0.6 years ) who suffered from recurrent nonspecific low back pain participated in either the exercise rehabilitation program or a control condition . Pre- and postintervention measures of low back pain status and biological risk indicators were taken . Two-way mixed ANOVA was conducted and significance was set at p exercise rehabilitation group for perceived severity of pain ( effect size 1.47 ) and number of occasions missing physical activity ( effect size 0.99 ) . Significant improvement in the exercise rehabilitation group for sit- and -reach performance , hip range of motion , lumbar sagittal mobility ( modified Schöber ) , and number of sit-ups in 60 s were also identified . In conclusion , the specific exercise program appeared to provide positive benefits for adolescents suffering from recurrent nonspecific low back pain . Further evaluation is required to evaluate the effectiveness of the exercise rehabilitation program in relation to other interventions and to assess the long-term effectiveness"
] | 41163bca-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Dysmenorrhoea is the occurrence of painful menstrual cramps of uterine origin and is a very common gynaecological complaint . Medical therapy for dysmenorrhoea includes oral contraceptive pills ( OCP ) and nonsteroidal anti-inflammatory drugs ( NSAIDS ) which both act by suppressing prostagl and in levels . While these treatments are very successful there is still a 20 - 25 % failure rate and surgery has been an option for cases of dysmenorrhoea that fail to respond to medical therapy . Uterine nerve ablation ( UNA ) and presacral neurectomy ( PSN ) are two surgical treatments that have become increasingly utilised in recent years . These procedures both interrupt the majority of the cervical sensory nerve fibres , thus diminishing uterine pain . Uncontrolled studies have supported the use of these procedures for primary dysmenorrhoea however both operations only partially interrupt some of the cervical sensory nerve fibres in the pelvic area ; therefore dysmenorrhoea associated with additional pelvic pathology may not always benefit from this type of surgery . OBJECTIVES To assess the effectiveness of surgical interruption of pelvic nerve pathways as treatment for primary and secondary dysmenorrhoea , and to determine the most effective surgical treatment . SEARCH STRATEGY Electronic search es of the Cochrane Menstrual Disorders and Subfertility Group Register of controlled trials , MEDLINE , and EMBASE were performed to identify relevant r and omised controlled trials ( RCTs ) . Attempts were also made to identify trials from citation lists of review articles and h and search ing . In most cases , the first or corresponding author of each included trial was contacted for additional information . SELECTION CRITERIA The inclusion criteria were r and omised comparisons of surgical techniques of interruption of the pelvic nerve pathways ( both open and laparoscopic procedures ) for the treatment of primary and secondary dysmenorrhoea . The main outcome measures were pain relief and adverse effects . DATA COLLECTION AND ANALYSIS Seven RCTs were identified that fulfilled the inclusion criteria for this review . One trial ( Sutton 1994 ) was excluded because another treatment was given in combination with destruction of pelvic nerve pathways and the effects of these two treatments could not be separated . Of the remaining six trials , three were included in the meta- analysis ( Chen 1996 , C and iani 1992 , Lichten 1987 ) . The results of the other three trials ( Dover 1999 , Tjaden 1990 , Vercellini 1997 ) were included in the text of the review for discussion because the data were not available in a form that allowed them to be combined in a meta- analysis . MAIN RESULTS For the treatment of primary dysmenorrhoea there is some evidence of the effectiveness of uterine nerve ablation ( UNA ) when compared to a control of no treatment . The comparison between UNA with presacral neurectomy ( PSN ) for primary dysmenorrhoea showed no significant difference in pain relief in the short term , however long term PSN was shown to be significantly more effective . For the treatment of secondary dysmenorrhoea the identified RCTs addressed only endometriosis . The treatment of UNA combined with surgical treatment of endometrial implants versus surgical treatment of endometriosis alone showed that the addition of UNA did not aid pain relief . For PSN combined with endometriosis treatment versus endometriosis treatment alone there was also no overall difference in pain relief , although the data suggests a significant difference in relief of midline abdominal pain . Adverse events were significantly more common for presacral neurectomy , however the majority were complications such as constipation , which may spontaneously improve . REVIEW ER 'S CONCLUSIONS There is insufficient evidence to recommend the use of nerve interruption in the management of dysmenorrhoea , regardless of cause . Future RCTs should be undertaken | [
"STUDY OBJECTIVE To assess the effectiveness of laparoscopic uterine nerve ablation ( LUNA ) in women with dysmenorrhea caused by uterine myomas treated by laparoscopic bipolar coagulation of uterine vessels ( LBCUV ) . DESIGN Prospect i ve , r and omized , longitudinal study ( Canadian Task Force classification II-1 ) . SETTING Private practice , university-affiliated hospital . PATIENTS Eighty-five women with uterine leiomyomas and associated dysmenorrhea . INTERVENTION Laparoscopic bipolar coagulation of uterine vessels with or without LUNA . MEASUREMENTS AND MAIN RESULTS Of 85 patients who entered the study , 41 were assigned to undergo LBCUV-LUNA ( group A ) , which was successful in 40 ( 97.6 % ) . In 44 women assigned to have LBCUV only ( group B ) , 43 ( 97.7 % ) underwent successful surgery . Eighty women completed 1- , 3- , and 6-month follow-up ( 38 group A , 42 group B ) . The groups did not differ significantly in age , history of abdominopelvic surgery , intraperitoneal adhesions , endometriosis , concomitant surgery , and operating time . Seven ( 18.4 % ) of 38 women in group A and 12 ( 28.6 % ) of 42 in group B experienced lower abdominal pain postoperatively . Acceptable pain was defined as a score of zero or 1 : 31 and 30 women in groups A and B reported scores of zero ; 3 and 2 reported scores of 1 ; 4 and 8 reported scores of 2 ; zero and 2 reported scores of 3 ; and no patients reported scores of 4 . The frequency and severity of postoperative pain were less in group A than in group B ( both p efficacy of both methods was almost equal in shrinking the uterus and dominant myoma , and in improving menorrhagia and bulk-related symptoms . Dysmenorrhea improvement was 84.2 % and 61.9 % in groups A and B at 3 months and 92.1 % and 73.8 % at 6 months , respectively . This was more significant in group A than in group B ( p LUNA may decrease postoperative ischemic pain and improve dysmenorrhea associated with uterine myomas treated by LBCUV",
"Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form",
"OBJECTIVE To assess the efficacy of laser laparoscopic surgery in the treatment of pain associated with minimal , mild , and moderate endometriosis . DESIGN A prospect i ve , r and omized , double-blind , and controlled clinical study . SETTING Royal Surrey County Hospital , Guildford , United Kingdom , a referral center for the laser laparoscopic treatment of endometriosis . PATIENTS Sixty-three patients with pain ( dysmenorrhoea , pelvic pain , or dyspareunia ) and minimal to moderate endometriosis . INTERVENTIONS The patients were r and omized at the time of laparoscopy to laser ablation of endometriotic deposits and laparoscopic uterine nerve ablation or expectant management . Pain symptoms were recorded subjectively and by visual analogue scale . The women were unaware of the treatment allocated as was the nurse who assessed them at 3 and 6 months after surgery . MAIN OUTCOME MEASURE Improvement or resolution of pain symptoms assessed subjectively and by visual analogue score . RESULTS Laser laparoscopy results in statistically significant pain relief compared with expectant management at 6 months after surgery . Sixty-two and a half percent of the lasered patients reported improvement or resolution of symptoms compared with 22.6 % in the expectant group . Results were poorest for minimal disease and , if patients with mild and moderate disease only are included , 73.7 % of patients achieved pain relief . There were no operative or laser complications . CONCLUSIONS Laser laparoscopy is a safe , simple , and effective treatment in alleviating pain symptoms in women with stages I , II , and III endometriosis",
"With approximately 25 % of dysmenorrheic patients reporting no improvement with nonsteroidal anti-inflammatory drugs , a study was devised to evaluate the effectiveness of a laparoscopic technique for the interruption of the uterosacral nerves . In a double-blind study of 21 patients with primary dysmenorrhea , 81 % ( 9 of 11 ) reported significant relief from menstrual pain after the surgery . Performed as an outpatient procedure , laparoscopic uterine nerve ablation may alleviate dysmenorrheic complaints when other modalities have failed . Half the treated women reported continued relief of menstrual pain at 12 months . These results suggest that uterosacral nerve interruption may prove an effective alternative treatment for this menstrual disorder",
"OBJECTIVE To assess the longer term efficacy of laparoscopic laser surgery in the treatment of painful pelvic endometriosis and to observe the natural history of the disease at second-look laparoscopy in a control group . DESIGN One-year follow-up of a prospect i ve , r and omized , double-blind controlled trial . SETTING A referral center for the laparoscopic laser treatment of endometriosis . PATIENT(S ) Sixty-three patients with pelvic pain and minimal to moderate endometriosis . INTERVENTION(S ) After the 6-month follow-up visit , the r and omization code was broken , and follow-up was continued to 1 year . Symptomatic patients were offered second-look laser laparoscopy . MAIN OUTCOME MEASURE(S ) Continued symptom relief at 1 year after treatment and findings at second-look laparoscopy in symptomatic controls . RESULT ( S ) Symptom relief continued at 1 year in 90 % of those who initially responded . All symptomatic controls had a second-look procedure , with 7 ( 29 % ) showing disease progression , 7 ( 29 % ) showing disease regression , and 10 ( 42 % ) having static disease . CONCLUSION ( S ) The benefits of laser laparoscopy for painful pelvic endometriosis are continued in the majority of patients at 1 year . Untreated painful endometriosis will progress or remain static in the majority of patients but will spontaneously improve in others",
"OBJECTIVE Our objective was to evaluate the efficacy of presacral neurectomy combined with conservative surgery for the treatment of pelvic pain associated with endometriosis . STUDY DESIGN In a r and omized , controlled study performed in a tertiary institution 71 patients with moderate or severe endometriosis and midline dysmenorrhea were r and omly assigned to conservative surgery alone ( n = 36 ) or conservative surgery and presacral neurectomy ( n = 35 ) . Main outcome measures were relief of dysmenorrhea , pelvic pain , and deep dyspareunia after surgery according to a multidimensional and an analog pain scale . RESULTS Presacral neurectomy markedly reduced the midline component of menstrual pain , but no statistically significant differences were observed between the two groups in the frequency and severity of dysmenorrhea , pelvic pain , and dyspareunia in the long-term follow-up . After presacral neurectomy , constipation developed or worsened in 13 patients and urinary urgency occurred in three and a painless first stage of labor in two . CONCLUSION Presacral neurectomy should be combined with conservative surgery for endometriosis only in selected cases",
"OBJECTIVE To compare laparoscopic presacral neurectomy and laparoscopic uterine nerve ablation for primary dysmenorrhea . STUDY DESIGN Sixty-eight patients with primary dysmenorrhea and a poor response to medical treatment were r and omized into two groups . One group ( 33 patients ) had laparoscopic presacral neurectomy ( LPSN ) and the other group ( 35 patients ) , laparoscopic uterine nerve ablation ( LUNA ) . RESULTS There were no complications , and all the patients left the hospital within 24 hours after surgery . The efficacy of both surgical methods was almost equal ( 87.9 % vs. 82.9 % ) at the 3-month postoperative follow-up visit , but the efficacy of LPSN was significantly better than that of LUNA ( 81.8 % vs 51.4 % ) at the 12-month visit . CONCLUSION LPSN is a valid option for treating primary dysmenorrhea",
"The present study was undertaken to evaluate prospect ively the efficacy of presacral neurectomy for the treatment of midline dysmenorrhea . All patients had moderate to severe dysmenorrhea and stage III-IV endometriosis . Of the patients undergoing presacral neurectomy ( N=17 ) , only two had a recurrence of pain . The remainder of the patients undergoing presacral neurectomy remain pain-free at 42 months of follow-up . Of the patients undergoing resection of endometriosis but not presacral neurectomy ( N=9 ) , none received relief of midline pain . Relief of lateral pain , back pain , and dyspareunia was variable in both groups . Our findings corroborate previous retrospective studies showing that presacral neurectomy is highly effective in the treatment of dysmenorrhea . We speculate that the most common reasons for failure of presacral neurectomy are inappropriate selection of patients and incomplete resection of the presacral nerve"
] | 41163c1a-06ff-11f0-808a-c43d1ab1c353 |
Introduction : Acne scarring is a very common problem , which can be extensive , and may lead to significant psychosocial morbidity . Multiple types of treatments are used to ameliorate atrophic scars with varying degrees of success . This paper provides an overview of the various energy-based modalities that are commonly employed against acne scarring . Objectives and methods : A comprehensive literature search of papers published since 2008 was performed in order to determine the efficacy and adverse reactions of commonly used energy-based treatments against post-acne scarring . Results : A total of 59 relevant articles were identified covering a multitude of different devices . Discussion : Ablative lasers seem to achieve the highest degree of efficacy , albeit this is associated with significant pain and downtime , and the risk for long-term pigmentary changes . Non-ablative fractional photothermolysis ( FP ) has a much safer profile but can not achieve as good cosmetic results . The efficacies of fractional radiofrequency microneedling and radiofrequency are slightly inferior to that of FP but offer an even safer adverse profile . Little evidence is available on the remaining devices , with larger studies required in order to reach more solid conclusions . Conclusion : Multiple devices have been used with varying levels of efficacy and very different safety profiles . There is an overall lack of high- quality evidence about the effects of different interventions . Furthermore , no st and ardised scale is available for acne scarring , leading to variability in evaluation and interpretation of data in different studies | [
"BACKGROUND Many methods have been proposed for the treatment of acne scars , with variable cosmetic results . Nonablative skin resurfacing is one method that has been proposed . Because of a need for more noticeable clinical improvements , the ablative fractional laser was recently introduced . OBJECTIVE To reduce complications and improve the results of ablative fractional laser resurfacing by combining this treatment of acne scars with nonablative lasers . METHODS A series of 20 patients ( skin phototypes IV – V ) with atrophic facial acne scars were r and omly divided into two groups that received three successive monthly treatments with an ablative fractional laser using high ( group A ) and low ( group B ) energy on one facial half and an ablative fractional laser with low energy plus a nonablative resurfacing laser on the other facial half . Patients were evaluated using digital photography at each treatment visit and at 3 months postoperatively . Clinical assessment scores were determined at each treatment session and follow‐up visit . RESULTS Although the use of the ablative fractional laser with high energy result ed in an improvement in patients ' acne scars , the combination of ablative fractional laser resurfacing and nonablative laser resurfacing yielded the best results , as assessed in photographs as well as by the overall appearance of the acne scars . With the combination method , fewer complications were observed . The authors have indicated no significant interest with commercial supporters",
"Bipolar fractional radiofrequency ( FRF ) device was firstly FDA -approved for treating atrophic acne scar in 2008 through the process of dermal coagulation and minimal epidermal ablation . The average energy at 60 mJ/pin was widely used to treat atrophic acne scars . However , the higher energy was delivered , the deeper ablation and coagulation were found . At present , the new generation of a device with bipolar FRF technology with electrode-pin tip was developed to maximize ability to deliver energy up to 100 mJ/pin . The objective of the study was to explore and compare the efficacy of utilizing high energy ( 100 mJ/pin ) and moderate energy ( 60 mJ/pin ) of bipolar fractional radiofrequency in treatment of atrophic acne scar in Asians . This is a split-face , double-blinded , r and omized control trial , pilot study by using parallel group design technique . Thirty healthy subjects with Fitzpatrick skin phototype III-IV diagnosed as atrophic acne scares were enrolled . All subjects received four monthly sessions of bipolar FRF treatment . Left and right facial sides of individual patients were r and omly assigned for different energy ( high energy at 100 mJ/pin versus moderate energy at 60 mJ/pin ) . Acne scars improvement was blinded grade d by dermatologist using global acne scarring score ( GASS ) which was subjectively evaluated at baseline , 1- , 3- , and 6-month follow-up . Objective scar analysis was also done using UVA-light video camera to measure scar volume , skin smoothness , and wrinkle at baseline , 3- , and 6-month follow-up after the last treatment . Side effects including pain , erythema , swelling , and crusting were also recorded . Thirty subjects completed the study with full 4-treatment course . The mean GASS of high energy side and moderate energy side was significantly reduced at 1- , 3- , and 6-month follow-up visits . At 1 month follow-visit , high energy side demonstrated significant improvement compared with moderate energy side ( p = 0.03 ) . Postinflammatory hyperpigmentation ( PIH ) developed in 21/120 sessions in high energy side ( 17.5 % ) and 16/120 sessions in moderate energy side ( 13.3 % ) . Pain score and the duration of erythema after treatments were significant higher on the side that was treated with high energy . Bipolar FRF device was safe and effective in the treatment of atrophic acne scars in Asians . High energy setting demonstrated significant higher efficacy at 1 month follow-visit . However , the efficacy of both energy setting s was comparable at 3- and 6-month follow-up . In addition , side effects were significantly more intense on the side treated with high energy",
"BACKGROUND The efficacy and safety of nonablative fractional laser for acne scars treatment has been described in several studies . Recently , microneedling treatment has been showing promising results with lower costs , quick healing time , and low risk of postinflammatory hyperpigmentation ( PIH ) . OBJECTIVE To compare the effectiveness and safety of nonablative fractional erbium laser 1,340 nm and microneedling for the treatment of facial atrophic acne scars . METHODS Forty-six patients with atrophic facial acne scars were r and omized to microneedling and laser groups , receiving 3 sessions performed monthly . Two blinded dermatologists applied the vali date d “ Quantitative Global Grading System for Postacne Scarring ” scale , before , 2 months , and 6 months after the treatment . Side effects were recorded at each follow-up visit and patient 's satisfaction was evaluated . RESULTS Both groups showed a significant improvement , and there was no statistically significant difference between results of both therapies ( p = .264 ) . The erythema after each session was longer in the laser group and 13.6 % subjects experienced PIH . No PIH was observed in the microneedling group . CONCLUSION This study shows that both nonablative fractional laser 1,340 nm and microneedling are comparable and effective in the treatment of atrophic acne scars . Microneedling is well tolerated , with fewer side effects and lower down time",
"BACKGROUND Current treatments for acne scars and enlarged facial pores have shown limited efficacy . OBJECTIVE To evaluate the efficacy and safety of the fractional photothermolysis system ( FPS ) with dynamic operating mode on acne scars and enlarged pores . MATERIAL S AND METHODS Twelve patients with mild to moderate atrophic acne scars and enlarged pores were included in this study . Three sessions of FPS treatment were performed for acne scars and facial pores monthly . Two blinded dermatologists who compared before and after photos based on a quartile grading scale conducted objective clinical assessment s of acne scar– and facial pore – treated areas . We took a biopsy immediately after one treatment with the laser from one of the authors to assess the histologic effects of the laser on facial pores . RESULTS Follow-up results at 4 months after the last treatment revealed that , of the 12 patients , for acne scars , five demonstrated clinical improvements of 51 % to 75 % and three demonstrated improvements of 76 % to 100 % , and for facial pores , five demonstrated moderate clinical improvements of 26 % to 50 % and three demonstrated improvements of 76 % to 100 % . Side effects , including pain , post-treatment erythema , and edema , were resolved within 1 week . CONCLUSION We suggest that the FPS may provide a new treatment algorithm in some cases with acne scars and enlarged pores . Considering the lack of placebo-controlled , split-face design of our study , optimized , prospect i ve studies should be conducted to fully assess the efficacy of FPS with dynamic operating mode",
"BACKGROUND Nonablative laser is gaining popularity because of the low risk of complications , especially in patients with darker skin . OBJECTIVE To compare the efficacy and safety of a long‐pulse neodymium‐doped yttrium aluminium garnet ( Nd : YAG ) laser and a combined 585/1,064‐nm laser for the treatment of acne scars . MATERIAL S AND METHODS Nineteen patients with mild to moderate atrophic acne scars received four long‐pulse Nd : YAG laser or combined 585/1,064‐nm laser treatment sessions at fortnightly intervals . Treatments were administered r and omly in a split‐face manner . RESULTS Acne scars showed mild to moderate improvement , with significant Echelle d'évaluation clinique des cicatrices d'acné ( ECCA ) score reductions , after both treatments . Although intermodality differences were not significant , combined 585/1,064‐nm laser was more effective for deep boxcar scars . In patients with combined 585/1,064‐nm laser‐treated sides that improved more than long‐pulse Nd : YAG laser‐treated sides , ECCA scores were significantly lower for combined 585/1,064‐nm laser treatment . Histologic evaluations revealed significantly greater collagen deposition , although there was no significant difference between the two modalities . Patient satisfaction scores concurred with physicians ' evaluations . CONCLUSION Both lasers ameliorated acne scarring with minimal downtime . In light of this finding , optimal outcomes might be achieved when laser treatment types are chosen after considering individual scar type and response . The authors have indicated no significant interest with commercial supporters",
"Fractional photothermolysis has been shown to improve various types of scarring , including atrophic acne scars . The aim of the present authors was to assess the efficacy and safety of the nonablative fractional photothermolysis in the treatment of moderate and severe acne scars . Eighty-seven patients with moderate or severe acne scarring were treated with six sessions with a 1540-nm Erbium glass fiber laser at 3-week intervals . Six months after the final session , 7/87 ( 8 % ) patients showed a moderate improvement , whereas 80/87 ( 92 % ) patients had a marked improvement . In a subset of patients , the present authors also applied in vivo reflectance confocal microscopy to highlight the relevant microscopic changes . Hence , early and late posttreatment findings , most importantly the replacement of a coarser collagen with a new one , similar to the collagen seen in healthy skin , were observed . In accordance to previous studies , the present authors conclude that nonablative fractional photothermolysis is a safe and effective treatment for moderate or severe acne scarring",
"BACKGROUND AND OBJECTIVES Acne scarring is a common and difficult to treat condition . The plasma skin regeneration ( PSR ) system is a novel device that causes delayed ablation of the epidermis and controlled thermal modification to the underlying dermis . PSR has previously been shown to be a safe and effective treatment for facial rhytides and benign skin lesions . In this study , we investigated the safety and efficacy of single-treatment , high-energy , double-pass PSR for the treatment of acne scarring . STUDY DESIGN / MATERIAL S AND METHODS Ten patients with acne scarring and Fitzpatrick skin types I-III were included in the study . All patients underwent a single PSR treatment with two high-energy passes ( 3.5 - 4.0 J ) . Treatments were performed in an outpatient clinic setting . Nine patients completed 6 months of follow-up . Improvement was determined by patient question naires and physician evaluation of digital photographs taken prior to treatment and at 3 and 6 months post-treatment . RESULTS On average , patients reported 34 % improvement in their acne scarring at 3 months and 33 % improvement at 6 months . Blinded physician ratings of patient photos demonstrated 19 % improvement at 3 months and 34 % at 6 months . Re-epithelialization was complete by 4 - 6 days after treatment , and no serious adverse events were encountered . CONCLUSION PSR appears to provide a safe and effective single treatment , minimal downtime alternative for the treatment of acne scarring . Additional studies are warranted to further demonstrate the safety and efficacy of this device",
"Fractional microneedling radiofrequency ( FMR ) is one of the promising methods in acne treatment . Moreover , bipolar radiofrequency ( BR ) generates heat thereby which induces neocollagenosis . FMR may have the potential to be a safe and effective treatment for the patients both with acne and acne scar . This study was performed to compare the efficacy and safety of FMR and BR in acne and acne scar treatment . Furthermore , mechanism of the FMR treatment was investigated through skin tissues obtained from subjects . Twenty subjects with mild-to-moderate acne and acne scars were treated in a split-face manner with FMR and BR . Two sessions of treatment was done 4 weeks apart in a total 12-week prospect i ve single-blind , r and omized clinical trial . Clinical assessment and sebum measurement were carried out for the evaluation of efficacy and safety . Skin tissues were acquired for investigation of molecular changes . FMR was more effective for acne scar especially in icepick and boxcar scar compared to BR . Both inflammatory and non-inflammatory acne lesions decreased by 80 and 65 % in the FMR-treated side at the final visit of 12 weeks , respectively . FMR treatment result ed in significant reduction of sebum excretion . Both treatments showed no severe adverse effects other than erythema . The FMR showed superior efficacy in acne and acne scar compared with BR . Increased expression of TGFβ and collagen I and decreased expression of NF-κB , IL-8 are suggested to involve in the improvement of acne scar and acne lesion by FMR",
"Background : Despite the many advances , scarring , particularly acne or pimple scarring , does not have a satisfactory treatment . A new armamentarium in this field is this recently devised matrix-tunable radiofrequency technology , which utilizes radiofrequency emission in the treatment of acne scars . Aims : To evaluate the efficiency of the new matrix-tunable radiofrequency technology in patients with acne scars of varying sizes . Setting s and Design : A prospect i ve study of 30 r and omly selected patients with acne scars was carried out . Material and Methods : Thirty healthy patients with different types of acne scars – ice pick , box and rolling type – were r and omly selected . The scars were either shallow or deep , varied in size from 2 to 20 mm and ranged in number from 10 to 50 . These patients were first treated with broad-spectrum antibiotics and local exfoliating agents ( topical tretinoin 0.025 % ) and then subjected to matrix-tunable radiofrequency technology . Each scar was treated at intervals of 1 month . A maximum of four such sittings were carried out . Patients were followed-up every 15 days . Results were noted at the end of 2 months and 6 months . Improvement was assessed by using the visual analog scale ( VAS ) at 2 months and 6 months , and results were noted in terms of percentage improvement of the whole face by calculating an average of percentage improvement on the basis of interviews of the patient and his/her accompanying relatives . The visual analog scaling was performed by means of high-resolution digital photographs taken at the baseline and at each subsequent visit . Results : The VAS improvement in scars ranged from 10 to 50 % at the end of 2 months to 20 to 70 % at the end of 6 months . Of the 30 patients of acne scars , the cosmetic result was excellent ( > 60 % improvement ) in four , good ( 35–60 % improvement ) in 18 and moderate to poor ( reported burning sensation and a mild sunburn-like sensation for about 1 h after treatment . The patients reported a pinkish tone for 2–3 days . Importantly , with the help of some slight make up , all the 30 patients could return to work the following day . Conclusion : Matrix-tunable radiofrequency technology is a safe and economically viable option for the dermatologists for the treatment of acne scars , because of the effective results coupled with a low downtime",
"BACKGROUND Treatment of acne scars with ablative fractional CO2 laser appears to be an effective and well-tolerated treatment . However , so far the influence of treatment interval has not been evaluated . OBJECTIVE To evaluate whether treatment of acne scars with fractional CO2 laser resurfacing at 1-month interval achieves better results with no difference in the occurrence of adverse effects , than treatment given at 3-months interval . METHODS Patients ( n = 13 ) with symmetrical atrophic acne scars on right and left sides of the mid-face and lower-face were r and omized to two fractional CO2 laser treatments at 1-month versus 3-month intervals . Blinded on-site evaluations were performed 1 and 6 months after the last treatment on 10-point scales . Endpoints were scar atrophy , patient satisfaction , and adverse effects . RESULTS Pre-operatively , acne scars were moderately atrophic ( 5.86 ± 1.87 ) . After treatment acne scars appeared with less atrophy on both treated sides 1 month postoperatively ( 1-month interval 1.96 ± 1.23 , P improvement of scar atrophy at any time postoperatively ( P = 0.81 ) . Patients were moderately and equally satisfied with the treatment result on facial sides ( P = 0.93 ) . Postoperative adverse effects were minor and not influenced by the treatment interval . CONCLUSIONS Fractional CO2 laser resurfacing improves atrophic acne scars and a treatment interval of either 1-month or 3-months does not seem to influence the improvement of scar atrophy nor the occurrence of postoperative adverse effects ",
"BACKGROUND Although effective as a monotherapy for the treatment of inflammatory acne , the 1,450-nm diode laser is associated with considerable pain at higher fluences . MATERIAL S AND METHODS Eleven subjects were treated with a 1,450-nm diode laser in a split-face bilateral paired acne study . One-half of the face received a single-pass consisting of stacked double pulses . The other side received a double-pass treatment of single pulses . Setting s were 11 J/cm2 or lower as tolerated with appropriate dynamic cooling device ( range 25–35 ) . RESULTS The mean pain rating was 5.33 on a 0 to 10 scale on the stacked – pulse treatment side and 5.12 on the double-pass side . Blinded reduction in mean acne lesion counts were 57.6 % and 49.8 % reduction , respectively . An overall acne scar improvement was seen in 83 % of subjects with acne scarring . Transient hyperpigmentation occurred in two patients on the stacked pulse side and completely resolved without sequelae . CONCLUSIONS The pulsed 1,450-nm diode laser can be used at lower fluences that elicit less discomfort yet effectively improve inflammatory acne . Stacking pulses appears to render a slightly higher efficacy than the multipass technique . Single-pulse , multiple-pass treatments may have a lower risk of cryogen-induced transient hyperpigmentation compared to st and ard high fluence techniques",
"BACKGROUND Non-ablative 1550-nm erbium-doped fractional photothermolysis systems ( FPS ) and 10 600-nm carbon dioxide fractional laser systems ( CO(2 ) FS ) have been effectively used to treat scars . OBJECTIVE We compared the efficacy and safety of single-session treatments of FPS and CO(2 ) FS for acne scars through a r and omized , split-face , evaluator-blinded study . METHODS Eight patients with acne scars were enrolled in this study . Half of each subject 's face was treated with FPS and the other half was treated with CO(2 ) FS . We used a quartile grading scale for evaluations . RESULTS At 3 months after the treatment , the mean grade of improvement based on clinical assessment was 2.0 + /- 0.5 for FPS and 2.5 + /- 0.8 for CO(2 ) FS . On each side treated by FPS and CO(2 ) FS , the mean duration of post-therapy crusting and scaling was 2.3 and 7.4 days respectively and that of post-therapy erythema was 7.5 and 11.5 days respectively . The mean VAS pain score was 3.9 + /- 2.0 with the FPS and 7.0 + /- 2.0 with the CO(2 ) FS . CONCLUSION We demonstrated the efficacy and safety of single-session acne scar treatment using FPS and CO(2 ) FS in East Asian patients . We believe that our study could be used as an essential reference when choosing laser modalities for scar treatment",
"BACKGROUND No studies have compared fractional microplasma radio frequency ( RF ) technology with the carbon dioxide fractional laser system ( CO2 FS ) in the treatment of atrophic acne scars in the same patient . OBJECTIVE To compare the efficacy and safety of fractional microplasma RF with CO2 FS in the treatment of atrophic acne scars . METHODS AND MATERIAL S Thirty‐three Asian patients received three sessions of a r and omized split‐face treatment of fractional microplasma RF or CO2 FS . RESULTS Both modalities had a roughly equivalent effect . Échelle d'Évaluation Clinique Des Cicatrices d'Acné scores were significantly lower after fractional microplasma RF ( from 51.1 ± 14.2 to 22.3 ± 8.6 , 56.4 % improvement ) and CO2 FS ( from 48.8 ± 15.1 to 19.9 ± 7.9 , 59.2 % improvement ) treatments . There was no statistically significant difference between the two therapies . Twelve subjects ( 36.4 % ) experienced postinflammatory hyperpigmentation ( PIH ) after 30 of 99 treatment sessions ( 30.3 % ) on the CO2 FS side and no PIH was observed on the fractional microplasma RF sides . CONCLUSION Both modalities have good effects on treating atrophic scars . PIH was not seen with the fractional microplasma RF , which might make it a better choice for patients with darker skin",
"BACKGROUND The therapeutic approach to the treatment of acne scars and photoaging varies according to the type of lesion . Traditional carbon dioxide ( CO2 ) laser is associated with long healing times , persistent erythema , and high risk of post‐inflammatory hyperpigmentation . Fractional laser technology , which involves the application of microscopic beams of pixilated light inducing focal zones of tissue injury surrounded by normal tissue , is currently used for the treatment of acne scars and photoaging . OBJECTIVE To compare the results obtained using CO2 fractional laser with those obtained using CO2 fractional laser plus radiofrequency for the treatment of atrophic acne scars and photoaging by means of clinical evaluation and confocal laser . MATERIAL S AND METHODS Ten patients with photoaging and acne scars underwent a single treatment using both technologies . Investigators and patients evaluated the clinical effect of the treatments using digital photographs , dermatoscopy , and in vivo reflectance confocal microscopy before and immediately , 1 week , and 3 months after treatment . RESULTS AND CONCLUSION Our results underlined the high efficacy of combining CO2 laser and radiofrequency , producing better results with fewer sessions , lower risks , and fewer side effects ",
"BACKGROUND Few studies have examined the role of fractional lasers in individual acne scars ( ice‐pick , box car , rolling ) using objective assessment tools in darkly pigmented skin . OBJECTIVE To evaluate the effect of 1,540‐nm fractional lasers on individual acne scars . METHODS and MATERIAL S A prospect i ve interventional study was conducted in 35 patients using a 1,540‐nm fractional laser . Six sessions were performed with four passes per session and a dose varying from 70 to 100 mJ to maximize the DWR . A self‐devised objective assessment tool with dose setting s to optimize the depth‐to‐width ratio ( DWR ) and a visual analog scale ( VAS ) were used to count individual atrophic scars . Final results were assessed 6 months after final laser treatment . RESULTS Acne scar reduction efficiency was used to vali date the improvement of individual scars , a meaningful difference was considered as 51 % or greater improvement . The boxcar scars ( 52.9 % ) responded better than the rolling ( 43.1 % ) and ice‐pick scars ( 25.9 % ) , with statistically significant improvement ( p sessions . Overall VAS scores revealed significant improvement ( p an erbium‐doped glass laser was found to improve atrophic acne scars , markedly so for boxcar and rolling scars . The VAS score overestimated improvement because of its subjective nature",
"BACKGROUND AND OBJECTIVE Acne scarring is a common complication of acne but no effective single treatment modality has been developed . To compare the efficacy of 1,550 nm Er : Glass fractional laser and chemical reconstruction of skin scar ( CROSS ) method in the treatment of acne scars . STUDY DESIGN / MATERIAL S AND METHODS A split-face trial was conducted in 20 patients ( 10 rolling , 10 icepick types ) with acne scars . One side was treated with the 1,550 nm Er : Glass fractional laser three times with a 6-week interval . And the other side was treated with CROSS method two times every 12 weeks . RESULTS Significant improvement was observed in both sides of the face . In rolling type , the objective and subjective improvement rates were significantly higher in the sides treated with laser than CROSS method . However , in icepick type , there were no statistically significant differences between the two treatment sides . In the laser sides , grade s of pain were significantly higher than that of treated with CROSS method . However , downtimes and lasting days of erythema were significantly longer in the sides treated with CROSS method . CONCLUSION A 1,550 nm Er : Glass fractional laser and CROSS method are both well-tolerated and effective treatment options in the acne scars . However , there was a relatively small difference between the two treatment modalities . Therefore , dermatologists should consider the acne scar type to select the treatment options . Lasers Surg . Med . 41:545 - 549 , 2009 . ( c ) 2009 Wiley-Liss ,",
"BACKGROUND The 1550 nm Er : Glass fractional laser is widely used for the treatment of atrophic acne scar . A novel fractional radiofrequency microneedle device has recently emerged as an alternative for treating acne scars . OBJECTIVES To evaluate the clinical efficacy and safety of a Er : Glass fractional laser and fractional radiofrequency microneedle device in the treatment of facial atrophic acne scars and to assess the difference between the treatment modalities depending on facial compartment . METHODS A total of 40 patients were equally r and omized into two groups . Each group of 20 patients received three treatments at 4-week interval using Er : Glass fractional laser or fractional radiofrequency microneedle device . RESULTS Scar severity scores ( ECCA grading scale ) improved by a mean of 25.0 % and 18.6 % in groups A and B , respectively ( both P side effects . CONCLUSION Atrophic acne scars improved in both groups without significant side effects . Additionally , the fractional laser was a more effective treatment option for acne scars , but the fractional radiofrequency microneedle device offered good adherence and short downtime",
"BACKGROUND Ablative resurfacing lasers are effective for treatment of acne scars , but they have a high risk of complications . Fractional lasers have less severe side effects but more moderate efficacy than ablative devices . Studies were performed in individuals with Fitzpatrick skin type I to VI . OBJECTIVE To determine the efficacy and safety of an erbium 1,550‐nm fractional laser in the treatment of facial acne scars in Fitzpatrick skin types IV to VI . METHODS We conducted a prospect i ve , single‐blind , r and omized trial in patients with acne scars ( n=15 ) , skin type IV to VI , with a 1,550‐nm erbium fractionated laser . Patients were divided into two groups ; one was treated with 10 mJ and the other with 40 mJ. Five monthly laser sessions were performed . A patient question naire was distributed . RESULTS There was a significant improvement in the acne scarring and overall appearance ( p No significant difference was found between 10 and 40 mJ. Patients were highly satisfied with their results . Significant postinflammatory hyperpigmentation was seen ; pain was significantly higher in darker skin . CONCLUSIONS Fractional photothermolysis is effective for the treatment of acne scars , but practition‐ers should be aware of the higher incidence of pain and postinflammatory hyperpigmentation in individuals with skin types IV to VI . The study was funded by Reliant Technologies , Inc. , which participated in the study design . Galderma ( Ft . Worth , TX ) provided Tri‐luma cream and GlaxoSmithKline ( Research Triangle Park , NC ) provided valacyclovir ( Valtrex )",
"Background : There have been no well-controlled studies evaluating the efficacy of combining 1540 nm nonablative fractional laser with percutaneous collagen induction ( PCI ) and trichloroacetic acid ( TCA ) 20 % in the treatment of atrophic acne scars . Objective : We hypothesized that combined alternating sessions of both modalities would show better results than each individual modality . Methods and material s : Thirty-nine patients with post acne atrophic scars were included in this study . Patients were r and omly equally divided into three groups ; group 1 was subjected to six sessions of PCI combined with TCA 20 % in the same session , group 2 was subjected to six sessions of 1540 nm fractional laser and group 3 was subjected to combined alternating sessions of the previously mentioned two modalities . Results : Scar severity scores improved by a mean of 59.79 % ( 95 % CI 47.38–72.21 ) ( p the degree of improvement was statistically significant when comparing the three groups using ANOVA test ( p = 0.004 ) . Conclusion : The current work recommends combining 1540 nm nonablative fractional laser in alternation with PCI and TCA 20 % in the treatment of atrophic acne scars",
"BACKGROUND AND OBJECTIVE To determine the efficacy and safety of a new method for treating acne scarring over a short-term period of 2 months and a long-term period of 6 months . MATERIAL S AND METHODS Six faces and 13 shoulders or backs for a total of 19 patients were treated , all of which displayed varying degrees of acne scarring , from moderate to severe . A newly developed high-power unipolar fractional ablative radiofrequency technology was used ( iPixel ™ RF , Alma Lasers , Caesarea , Israel ) , with acoustic pressure ultrasound guided dermal injection of the PixelTreat Scars preparation ( Alma Lasers ) , through RF Pixel fractionated microchannels . All patients underwent four treatment sessions at 3-week intervals . RESULTS Significant improvement was observed in scarring , both on the face ( P percentage of fading on total scarring was 57 % on the face and 49 % on the back and shoulders ; after 6 months , the percentage increased to 62 % on the face , and 58 % on the back and shoulders , respectively . Patients reported to be Somewhat Satisfied ( 16 % ) , Satisfied ( 53 % ) , and Very Satisfied ( 31 % ) . No unexpected side effects to the ablation and no hypersensitive reactions to PixelTreat Scars were observed . CONCLUSION The bimodal procedure is safe and effective in reducing acne scarring . This represents a new therapeutic alternative of great interest , to be used either as a monotherapy , or in combination with other treatments",
"BACKGROUND Non-ablative methods have been attempted in treating atrophic facial scars , but the histologic findings do not always coincide with the clinical results and patient satisfaction . OBJECTIVE To study the effects and safety of the Nd : YAG laser for treating atrophic facial scars . MATERIAL AND METHODS Twelve subjects ( skin phototypes II-V ) with mild to moderate atrophic facial acne scars received five monthly treatments with 1,064 nm Nd : YAG laser and were photographed before , in the middle of , and 6 months after the last treatment . Histologic evaluations were performed on skin biopsies obtained before treatment and 1 month after the last session . Collagen quantification per area , before and after the treatment , was performed by morphometry , with computerized image analysis . Patient satisfaction and clinical condition were assessed using st and ard grading scales . RESULTS Mild to moderate clinical improvement was observed in most patients . Photographic assessment of scars found visible cosmetic improvement in eleven patients . All patients were satisfied . There were statistically significant collagen increases in the dermis following the treatment . Side effects were limited to mild transient erythema and increased skin sensitivity after the procedure . CONCLUSIONS The 1,064 nm Nd : YAG laser is a safe and effective nonablative method for improving atrophic scars , even in darker skin",
"IMPORTANCE Fractional laser technology is routinely used in the treatment of acne scarring , with thermal injury result ing in collagen synthesis and remodeling . Use of a picosecond pulse duration with a diffractive lens array may be a new technologic advancement in the treatment of acne scarring . OBJECTIVE To investigate the safety and efficacy of a 755-nm alex and rite picosecond pulse duration laser with diffractive lens array for the treatment of facial acne scarring . DESIGN , SETTING , AND PARTICIPANTS This single-center , prospect i ve study performed in a private practice with a dedicated research department included patients with clinical ly diagnosed scarring secondary to inflammatory or cystic acne . INTERVENTIONS Patients received 6 treatments with a 755-nm picosecond laser with a spot size of 6 mm , fluence of 0.71 J/cm2 , repetition rate of 5 Hz , and pulse width of 750 picoseconds in combination with a diffractive lens array , allowing for greater surface area and pattern density per pulse . MAIN OUTCOMES AND MEASURES The pain and satisfaction scores for overall appearance and texture were recorded . Masked assessment of clinical photographs and analysis of 3-dimensional volumetric data were performed . Biopsy specimens were obtained for independent histologic evaluation by 2 investigators at baseline and at 3 months after last treatment . RESULTS Fifteen women and 5 men ( mean age , 44 years ; age range , 27 - 61 years ) with Fitzpatrick skin types I through V and facial acne scarring were enrolled . The mean pain score was 2.83 of 10 . Patients were satisfied to extremely satisfied with improvement in appearance and texture at their final treatment and follow-up visits . The masked assessment scores of 17 patients were 1.5 of 3 and 1.4 of 3 at 1 and 3 months , respectively ( a score of 0 indicates 0%-25 % improvement and a score of 3 indicates > 75 % improvement ) . A 3-dimensional analysis revealed a mean 24.3 % improvement in scar volume , maintained at 1 ( 24.0 % ) and 3 ( 27.2 % ) months after treatment . Histologic analysis revealed elongation and increased density of elastic fibers , with an increase in dermal collagen and mucin . CONCLUSIONS AND RELEVANCE Treatment of facial acne scars with a diffractive lens array and 755-nm picosecond laser produced improvement in appearance and texture at 3 months after the last treatment , with objective findings similar to those published for a series of fractional ablative laser treatments . Histologic findings suggest that improvement in scarring from this treatment goes beyond remodeling of collagen",
"OBJECTIVE This study evaluated the safety and efficacy of sublative fractional bipolar radiofrequency and bipolar radio frequency combined with diode laser for the treatment of both superficial and deep acne scars in patients with skin types II to V. DESIGN Prospect i ve , single-center study . Subjects received up to five treatments with sublative fractional bipolar radiofrequency and bipolar radiofrequency combined with diode laser . Treatments were directed to at least two facial ( forehead , perioral , cheeks ) and /or neck areas with acne scars at four-week intervals . Treatment parameters on each subject were based on skin type and on skin responses to test spots on the target area just before treatment . SETTING Physician office . PARTICIPANTS Subjects ( n=20 , aged 40.7±10.5 years [ mean ± SD ] , skin types II-V ) with acne scars and without acne lesions enrolled in this prospect i ve study . MEASUREMENTS RESULTS were evaluated just before each treatment and at four and 12 weeks after the final treatment using the Goodman Scar Scale , a quantitative method of evaluating scars that attempts to reduce grading subjectivity , as well as by patient satisfaction . RESULTS Acne scars improved significantly one month after three treatments and improvement persisted for at least 12 weeks after the fifth treatment . Improvement was not affected by skin type . Adverse effects were limited to transient erythema and edema . CONCLUSION The combination of diode laser and bipolar radiofrequency energy device in addition to fractionated sublative radiofrequency is a safe and statistically significantly effective combined modality for the treatment of both superficial and deep acne scars in patients with skin types II to V with minimal downtime and no significant side effects",
"BACKGROUND AND OBJECTIVES Ablative fractional resurfacing ( AFR ) is a new modality for photorejuvenation and acne scars which combines carbon dioxide ( CO₂ ) laser ablation with fractional photothermolysis . The objective is to evaluate the efficacy and side effects of a new fractional CO₂ ablative device ( Fraxel Re : pair ) for skin rejuvenation and acne scars in Asians . MATERIAL S AND METHODS Nine patients underwent one full-face treatment . The energy levels ranged from 30 - 70 mJ with coverage between 30 % and 45 % . Improvement in skin texture , laxity , wrinkles , enlarged pores , overall pigmentation irregularity , and adverse effects were assessed up to 6 months post-treatment . St and ardized photographs using the Canfield Visia CR system ® were assessed by two independent observers . Subjective improvement was assessed by patient question naires . RESULTS Nine Chinese patients ( skin types III and IV , mean age 44.8 ) were included . Statistically significant improvements were seen for skin texture , skin laxity , wrinkles , enlarged pores , and acne scars . The post-inflammatory hyperpigmentation rate was 55.5 % and 11.1 % at 1 and 6 months post-treatment , respectively . Eighty-six percent of patients were overall satisfied to very satisfied with the treatment . CONCLUSION Ablative fractional CO₂ laser resurfacing was overall safe and effective for skin rejuvenation and acne scars in Asians . However , in view of the high post-inflammatory rate and the statistically significant but only mild to moderate improvement after a single treatment as observed in this study , there is a need to review the current role of fractional ablative CO₂ laser treatment as compared to fractional non-ablative for skin rejuvenation and acne scar treatment in Asians",
"Several treatment modalities are used for the treatment of acne scars with variable results . Recent studies showed that fractional radiofrequency may be an effective treatment modality for acne scars . The objective of this study was to assess the efficacy , safety , tolerability and patient satisfaction of fractional bipolar radiofrequency ( RF ) , the eTwo ™ system ( Syneron C and ela Ltd. , Yokneam , Israel ) for treating acne scars . Twelve patients with moderate to severe acne scars received 3–5 treatments with the Sublative fractionated bipolar RF applicator of the eTwo device at 1‐month intervals . Patients were evaluated clinical ly and photographically at each visit and 3 months after the final treatment . Very good improvement ( at least one scale ) was seen after completing the five treatments . The patient satisfaction survey ( Global Aesthetic Improvement Scale scores ) revealed that half ( 6 out of 12 ) of the patients reported to be satisfied with treatment results , while the other half reported to be very satisfied . Beyond the expected erythema and minimal scab formation in the treated areas , which was mild and transient , none of the participants reported any adverse events . The data presented here support the high efficacy and safety of fractionated bipolar RF for the aesthetic improvement of moderate to severe acne scars",
"Background : A number of treatments for reducing the appearance of acne scars are available , but general guidelines for optimizing acne scar treatment do not exist . The aim of this study was to compare the clinical effectiveness and side effects of fractional carbon dioxide ( CO2 ) laser resurfacing combined with punch elevation with fractional CO2 laser resurfacing alone in the treatment of atrophic acne scars . Material s and Methods : Forty-two Iranian subjects ( age range 18–55 ) with Fitzpatrick skin types III to IV and moderate to severe atrophic acne scars on both cheeks received r and omized split-face treatments : One side received fractional CO2 laser treatment and the other received one session of punch elevation combined with two sessions of laser fractional CO2 laser treatment , separated by an interval of 1 month . Two dermatologists independently evaluated improvement in acne scars 4 and 16 weeks after the last treatment . Side effects were also recorded after each treatment . Results : The mean ± SD age of patients was 23.4 ± 2.6 years . Clinical improvement of facial acne scarring was assessed by two dermatologists blinded to treatment conditions . No significant difference in evaluation was observed 1 month after treatment ( P = 0.56 ) . Their evaluation found that fractional CO2 laser treatment combined with punch elevation had greater efficacy than that with fractional CO2 laser treatment alone , assessed 4 months after treatment ( P = 0.02 ) . Among all side effects , coagulated crust formation and pruritus at day 3 after fractional CO2 laser treatment was significant on both treatment sides ( P of fractional laser skin resurfacing with punch elevation offers a safe and effective approach for the treatment of acne scarring",
"BACKGROUND There is a paucity of studies investigating laser resurfacing in Fitzpatrick skin phototypes ( SPT ) IV to VI . OBJECTIVE To assess the efficacy and safety of fractional nonablative laser resurfacing in the treatment of acne scarring in patients with SPT IV to VI . METHODS AND MATERIAL S The authors conducted a r and omized , investigator-blinded and rater-blinded , split-face comparative study of adults with SPT IV to VI and facial acne scars treated with 2 different density setting s and the same fluence . RESULTS Quantitative global scarring grading system ( QGSGS ) scores were significantly improved from baseline at 16 and 24 weeks ( p = .0277 ) . Improvements in QGSGS scores after higher and lower density treatments were statistically similar ( p = .96 ) . The live-blinded dermatologist , the blinded dermatologist photoraters , and the patients rated scars as being significantly more improved by visual analog scale at weeks 16 and 24 compared with baseline ( p mild or moderate hyperpigmentation as an investigator observed site reaction . CONCLUSION The nonablative 1550-nm fractional laser is safe and efficacious in treating acne scaring in Fitzpatrick skin types IV to VI . Self-limited postinflammatory hyperpigmentation was a common occurrence , especially with higher treatment densities",
"The efficacy of nonablative fractional laser resurfacing of acne scars has been described in case reports and uncontrolled trials . The present study is the first r and omized controlled trial in this field . The aim of this study was to examine the efficacy and adverse effects of 1,540-nm nonablative fractional laser treatment of acne scars . Ten patients with acne scars were included . Two intraindividual areas of similar size and appearance within contralateral anatomical regions were r and omized to ( 1 ) 3-monthly laser treatments with a StarLux 1,540-nm fractional h and piece , and ( 2 ) no treatment . Blinded on-site clinical evaluations were performed before treatment , and at 4 and 12 weeks after the final treatment . End-points were overall change in scar texture ( from score 0 , even texture , to 10 , worst possible scarring ) , adverse effects , change in skin colour ( from score 0 , absent , to 10 , worst possible ) , and patient satisfaction ( from score 0 , no satisfaction , to 10 , best imaginable satisfaction ) . Before treatment , scars were moderately atrophic and uneven in texture on both treated and untreated sides ( median score 6.5 , interquartile range 4.5–8 ; P=1 ) . After treatment , laser-treated scars appeared more even and smooth than untreated control areas ( 4.5 , 2–6.5 , versus 6.5 , 4.5–8 , P=0.0156 , at 4 weeks ; 4.5 , 2.5–6.5 , versus 6.5 , 4.5–8 , at 12 weeks ; P=0.0313 ) . Patients were satisfied with the treatment ( 5.5 , 1–7 , after 12 weeks ) and five of the ten patients evaluated their acne scars as moderately or significantly improved . No differences were found in skin redness or pigmentation between before and after treatment . Patients experienced moderate pain , erythema , oedema , bullae , and crusts . No adverse effects were seen in untreated control areas . The nonablative 1,540-nm fractional laser improves acne scars with a minimum of adverse effects",
"BACKGROUND A proposal has recently been made regarding the potential adjuvant use of platelet‐rich plasma ( PRP ) with fractional carbon dioxide laser ( FCL ) for the correction of acne scars . OBJECTIVE To compare the efficacy and safety of two administration modes of autologous PRP ( intradermal injection ( ID ) and topical application ) after FCL with that of FCL alone in the treatment of atrophic acne scars . PATIENTS AND METHODS Thirty patients were r and omly divided into two groups . Both underwent split‐face therapy . Group 1 was administered FCL followed by ID PRP on one side and FCL followed by ID saline on the other . In group 2 , one cheek was treated with FCL followed by ID PRP , and the other received FCL followed by topical PRP . Each patient received 3 monthly sessions . The final assessment took place at 6 months . RESULTS Combined PRP‐ and FCL‐treated areas had a significantly better response ( p = .03 ) , fewer side effects , and shorter downtime ( p = .02 ) than FCL‐treated areas , but there were no significant differences in ID‐ and topical PRP – treated areas in degree of response and downtime ( p = .10 ) ; topically treated areas had significantly lower pain scores . CONCLUSION The current study introduces the combination of topical PRP and FCL as an effective , safe modality in the treatment of atrophic acne scars with shorter downtime than FCL alone and better tolerability than FCL combined with ID PRP",
"Abstract Background : Pinpoint irradiation technique CO2 LASER and Chemical Reconstruction Of Skin Scars ( CROSS ) are effective treatments for atrophic acne scars as fractional photothermolysis . Objective : This study was design ed to prospect ively compare the use of a pinpoint irradiation technique versus TCA CROSS in treating ice pick acne scars . Methods : Thirty-two patients with ice pick acne scars were included in this open , label pilot study . Pinpoint irradiation technique by CO2 LASER and TCA CROSS were applied for the study and control group , respectively . Twenty-eight patients with ice pick acne scars were included in this open , label pilot study . They were r and omly assigned to two groups : the first group ( 14 patients ) received pinpoint irradiation by CO2 LASER as a study group , and the second group ( 14 patients ) received TCA CROSS as a control group . In both treatments , there were four sessions at 3-week interval , and 3 months of follow up . Results : There were statistically significant difference in acne scar severity index and qualitative scarring grading system in the improvement results between the study and control groups ( p by CO2 LASER is safe and more effective than TCA CROSS technique . Clinical improvement was achieved in all 14 patients without dramatic adverse effects"
] | 41163c60-06ff-11f0-808a-c43d1ab1c353 |
The avoidance model in patients with knee and hip osteoarthritis ( OA ) hypothesizes that pain and psychological distress lead to avoidance of activities , and thereby to muscle weakness and activity limitations . This paper systematic ally review s the scientific evidence for the validity of this avoidance model . A qualitative data synthesis was used to identify levels of evidence . Sixty studies were included . In knee OA , strong evidence was found that avoidance of activities is associated with activity limitations via muscle weakness ( mediation by muscle weakness ) , strong evidence was found for an association between muscle weakness and activity limitations , and weak evidence was found that pain and psychological distress are associated with muscle weakness via avoidance of activities ( mediation by avoidance ) . In hip OA , weak evidence was found for mediation by muscle weakness ; and strong evidence was found for an association between muscle weakness and activity limitations . More research is needed on the consecutive associations between pain or psychological distress , avoidance of activities and muscle weakness , and to confirm causal relationships | [
"Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items",
"OBJECTIVE To determine the effect of quadriceps strength in individuals with knee osteoarthritis ( OA ) on loss of cartilage at the tibiofemoral and patellofemoral joints ( assessed by magnetic resonance imaging [ MRI ] ) and on knee pain and function . METHODS We studied 265 subjects ( 154 men and 111 women , mean+/-SD age 67+/-9 years ) who met the American College of Rheumatology criteria for symptomatic knee OA and who were participating in a prospect i ve , 30-month natural history study of knee OA . Quadriceps strength was measured at baseline , isokinetically , during concentric knee extension . MRI of the knee at baseline and at 15 and 30 months was used to assess cartilage loss at the tibiofemoral and patellofemoral joints , with medial and lateral compartments assessed separately . At baseline and at followup visits , knee pain was assessed using a visual analog scale , and physical function was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index . RESULTS There was no association between quadriceps strength and cartilage loss at the tibiofemoral joint . Results were similar in malaligned knees . However , greater quadriceps strength was protective against cartilage loss at the lateral compartment of the patellofemoral joint ( for highest versus lowest tertile of strength , odds ratio 0.4 [ 95 % confidence interval 0.2 , 0.9 ] ) . Those with greater quadriceps strength had less knee pain and better physical function over followup ( P cartilage loss at the tibiofemoral joint , including in malaligned knees . We report for the first time that greater quadriceps strength protected against cartilage loss at the lateral compartment of the patellofemoral joint , a finding that requires confirmation . Subjects with greater quadriceps strength also had less knee pain and better physical function over followup",
"OBJECTIVES To investigate the effect of 12 weeks of strength training in combination with a nonsteroidal anti-inflammatory drug ( NSAID ) , glucosamine , or placebo on muscle cross-sectional area ( CSA ) , strength ( primary outcome parameters ) , and function , power , pain , and satellite cell number ( secondary outcome parameters ) in patients with knee osteoarthritis ( OA ) . DESIGN Double-blinded , r and omized controlled trial . SETTING Hospital . PARTICIPANTS Patients ( N=36 ; 20 women , 16 men ; age range , 50 - 70y ) with bilateral tibiofemoral knee OA . A total of 181 patients were approached , and 145 were excluded . INTERVENTIONS Patients were r and omly assigned to treatment with the NSAID ibuprofen ( n=12 ) , glucosamine ( n=12 ) , or placebo ( n=12 ) during 12 weeks of quadriceps muscle strength training . MAIN OUTCOME MEASURES Muscle CSA and strength . RESULTS No differences between groups were observed in gains in muscle CSA . Training combined with ibuprofen increased maximal isometric strength by an additional .22Nm/kg ( 95 % confidence interval [ CI ] , .01-.42 ; P=.04 ) , maximal eccentric muscle strength by .38Nm/kg ( 95 % CI , .05-.70 ; P=.02 ) , and eccentric muscle work by .27J/kg ( 95 % CI , .01-.53 ; P=.04 ) in comparison with placebo . Training combined with glucosamine increased maximal concentric muscle work by an additional .24J/kg versus placebo ( 95 % CI , .06-.42 ; P=.01 ) . CONCLUSIONS In patients with knee OA , NSAID or glucosamine administration during a 12-week strength-training program did not improve muscle mass gain , but improved maximal muscle strength gain in comparison with treatment with placebo . However , we do not find that the benefits are large enough to justify taking NSAIDs or glucosamine",
"OBJECTIVES To examine the objective physical function of the lower extremities , to measure the properties of quadriceps femoris muscle ( QFM ) , and to assess subjective disabilities in men with knee osteoarthritis ( OA ) and to compare the results with those obtained from age- and sex-matched control subjects . DESIGN Cross-sectional study . SETTING Rehabilitation clinic in a university hospital . PARTICIPANTS Male volunteers ( n=54 ) ( age range , 50 - 69y ) with knee OA and r and omly selected healthy , age- and sex-matched control subjects ( n=53 ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Physical function evaluated with a test battery including the QFM composition measurement , the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , and the R AND 36-Item Short-Form Health Survey , version 1.0 . RESULTS Knee OA patients had 13 % to 26 % poorer ( P range , .050-.001 ) physical function and muscle strength compared with the controls . There were also significant differences in QFM composition . WOMAC ( P range , .050-.001 ) and muscle strength ( P passive knee motion , knee extension strength , and WOMAC were related to the severity of the disease ( P patients with knee OA exhibited impaired physical function and muscle strength and QFM composition compared with healthy controls . The severity of radiographic knee OA clearly had adverse effects on functional ability at the later stages of the disease . The results highlight the effect of QFM strength on physical function as well as the importance of patient 's subjective and objective physical function when deciding on knee OA treatment policy",
"OBJECTIVE To evaluate the effects of isokinetic exercise versus a program of patient education on pain and function in older persons with knee osteoarthritis . DESIGN A r and omized , comparative clinical trial , with interventions lasting 8 weeks and evaluations of 12 weeks . SETTING An outpatient Veterans Affairs Medical Center clinic and an affiliated university hospital . PATIENTS One hundred thirteen men and women between 50 and 80 years old with diagnosed osteoarthritis of the knee ; 98 completed the entire assigned treatment . INTERVENTION Patients received either a regimen of isokinetic exercise of the quadriceps muscle three times weekly over 8 weeks or a series of 4 discussion s and lectures led by health care professionals . MAIN OUTCOME MEASURES Variables studied for change were isokinetic and isometric quadriceps strength , pain and function determined by categorical and visual analog scales , and overall status using physician and patient global evaluations by the Arthritis Impact Scale , version 2 , Western Ontario McMaster 's Arthritis Index , and Medical Outcome Study Short Form 36 . RESULTS Both treatment groups showed significant strength gains ( p pain scores for more of the variables measured than those receiving education . Both groups had positive functional outcomes and slightly improved measures of overall status . CONCLUSIONS Isokinetic exercise is an effective and well-tolerated treatment for knee osteoarthritis , but a much less costly education program also showed some benefits",
"BACKGROUND Valid outcome measurement tools are required to reliably demonstrate the effectiveness and clinical outcomes of lower-extremity arthroplasty . Having ascertained a lack of a practical and valid measure of the change in actual daily physical activity that occurs prior to and following lower-limb arthroplasty , we developed and vali date d a lower-extremity activity scale . METHODS The eighteen-level self-administered scale was developed with the aid of content experts to ensure face validity . Validity and reliability were assessed with the use of ( 1 ) pedometer measurements of seventy subjects over seven days ; ( 2 ) next-of-kin proxy measurements of the activity levels of ninety patients before they underwent lower-limb arthroplasty ; and ( 3 ) application , and correlation with the Western Ontario and McMaster Universities Osteoarthritis Index scores , in a prospect i ve seventeen-center clinical study of 297 consecutive patients undergoing revision total knee arthroplasty . In this latter study , demographic and comorbidity data were also collected . Univariate and bivariate correlations were performed , and a multivariate structured equation modeling approach was used to further test responsiveness , reliability , and validity of the lower-extremity activity scale . RESULTS Pedometer readings correlated with the activity levels derived with the lower-extremity activity scale ( r = 0.79 ) . Of note was the finding that age , weight , and body mass index did not correlate well with the average number of steps per day ( r = -0.32 , -0.32 , and -0.25 , respectively ) . A significant correlation was found between the lower-extremity activity scores recorded by the patients and those reported by their next of kin ( Pearson correlation , r = 0.715 ; p = 0.0001 ) and between the initial lower-extremity activity scores and two-week-retest scores ( intraclass correlation = 0.9147 ; p lower-extremity activity scale was responsive , accurately reflecting changes in the patient 's condition between baseline and the time of follow-up ( p activity scale was established by correlations with the function scores ( r = -0.301 , p pain scores ( r = -0.241 , p diminished activity in patients who had more difficulty in functioning and a greater number of comorbidities . CONCLUSIONS We developed a lower-extremity activity scale and vali date d that it was an effective instrument for the assessment of patients ' actual activity levels . It is easy to apply and interpret , and it is valid and ready for use in the clinical setting . This scale will allow more accurate analysis and prediction of outcomes . Consequently , it will become a useful , practical adjunct to objective clinical decision-making and intervention for patients undergoing arthroplasty",
"OBJECTIVE To test the effects of a high intensity home-based progressive strength training program on the clinical signs and symptoms of osteoarthritis ( OA ) of the knee . METHODS Forty-six community dwelling patients , aged 55 years or older with knee pain and radiographic evidence of knee OA , were r and omized to a 4 month home based progressive strength training program or a nutrition education program ( attention control ) . Thirty-eight patients completed the trial with an adherence of 84 % to the intervention and 65 % to the attention control . The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index pain and physical function subscales . Secondary outcomes included clinical knee examination , muscle strength , physical performance measures , and question naires to measure quality of life variables . RESULTS Patients in the strength training group who completed the trial had a 71 % improvement in knee extension strength in the leg reported as most painful versus a 3 % improvement in the control group ( p self-reported pain improved by 36 % and physical function by 38 % in the strength training group versus 11 and 21 % , respectively , in the control group ( p = 0.01 for between group comparison ) . In addition , those patients in the strength training group who completed the trial had a 43 % mean reduction in pain ( p = 0.01 vs controls ) , a 44 % mean improvement in self-reported physical function ( p physical performance , quality of life , and self-efficacy when compared to the control group . CONCLUSION High intensity , home based strength training can produce substantial improvements in strength , pain , physical function and quality of life in patients with knee OA",
"Our objective was to investigate whether behavioral grade d activity ( BGA ) has particular benefit in specific subgroups of osteoarthritis ( OA ) patients . Two hundred participants with OA of hip or knee , or both ( clinical American College of Rheumatology , ACR , criteria ) participated in a r and omized clinical trial on the efficacy of BGA compared to treatment according to the Dutch physiotherapy guideline ( usual care ; UC ) . Changes in pain ( Visual Analog Scale , VAS ) , physical functioning ( Western Ontario and McMaster Universities Osteoarthritis Index , WOMAC , and McMaster Toronto Arthritis Question naire , MACTAR ) , and patient global assessment were compared for specific subgroups . Subgroups were assigned by the median split method and were analyzed using analysis of covariance . Beneficial effects of BGA were found for patients with a relatively low level of physical functioning ( p?0.03 ) . Furthermore , beneficial effects of BGA in patients with a low level of internal locus of control were marginally significant ( p = .05 ) . Patients with a relatively low level of physical functioning benefit more from BGA compared to UC . Compared to UC , BGA is the preferred treatment option in patients with a low level of physical functioning",
"OBJECTIVES To identify the determinants of self-report mobility measures in people with knee osteoarthritis ( OA ) and to compare self-report measures with physical performance . DESIGN Cross-sectional , prospect i ve . SETTING Motor performance laboratory and human mobility research center . PARTICIPANTS A convenient sample of 54 participants with medial compartment knee OA ( 32 women , 22 men ; age 68.3+/-8.7y ; range , 50 - 87y ) . Three participants were excluded because of the presence of lateral knee OA on radiographs . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Self-reports were recorded by using the Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) and the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) . Performance measures included the six-minute walk test ( 6MWT ) , Timed Up & Go ( TUG ) test , and a st and ardized stair-climbing task ( STR ) . RESULTS Stepwise linear regression analysis identified models that included pain , quadriceps and hamstrings strength , and depression to explain 62 % to 73 % of the variance in scores on the physical functioning subscale of the WOMAC and the SF-36 . These self-report measures had a moderate relation ( r range , .46-.64 ) with performance measures ( 6MWT , TUG , STR ) . CONCLUSIONS Self-report measures were strongly related to pain ; physical performance measures were strongly related to self-efficacy . Regression models showed that self-report scores reflect pain , knee strength , and depression . The relation between self-report and performance measures was moderate , suggesting that these examine different aspects of mobility",
"Objective : To determine the additional prognostic value of clinical history , physical examination and x-ray findings to a previously derived simple generic model ( age , body mass index , anxiety and pain severity ) in a cohort of older adults with knee pain . Methods : Prospect i ve cohort study in community-dwelling adults in North Staffordshire . 621 participants ( aged ⩾50 years ) reporting knee pain who attended a research clinic at recruitment and were followed up by postal question naire at 18 months . Poor functional outcome was measured by the Physical Functioning Scale of the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) at 18-month follow-up defined in 60 % of participants . Results : Three clinical history variables ( bilateral knee pain , duration of morning stiffness and inactivity gelling ) were independently associated with poor outcome . The addition of the “ clinical history ” model to the “ generic ” model led to a statistical improvement in model fit ( likelihood ratio ( LR ) = 24.84 , p = 0.001 ) . Two physical examination variables ( knee tender point count and single-leg balance ) were independently associated with poor outcome but did not lead to a significant improvement when added to the “ clinical history and generic ” model ( LR = 6.34 , p = 0.50 ) . Functional outcome was significantly associated with severity of knee radiographic osteoarthritis ( OA ) , but did not lead to any improvement in fit when added to the “ generic , clinical history and physical examination ” model ( LR = 1.86 , p = 0.39 ) . Conclusions : Clinical history , physical examination and severity of radiographic knee OA are of limited value over generic factors when trying to predict which older adults with knee pain will experience progressive or persistent functional difficulties"
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BACKGROUND The patient with diabetes has many different learning needs relating to diet , monitoring , and treatments . In many health care systems specialist nurses provide much of these needs , usually aim ing to empower patients to self-manage their diabetes . The present review aims to assess the effects of the involvement of specialist nurse care on outcomes for people with diabetes , compared to usual care in hospital clinics or primary care with no input from specialist nurses . OBJECTIVES To assess the effects of diabetes specialist nurses / nurse case manager in diabetes on the metabolic control of patients with type 1 and type 2 diabetes mellitus . SEARCH STRATEGY We carried out a comprehensive search of data bases including the Cochrane Library , MEDLINE and EMBASE to identify trials . Bibliographies of relevant papers were search ed , and h and search ing of relevant publications was undertaken to identify additional trials ( Date of last search November 2002 ) . SELECTION CRITERIA R and omised controlled trials and controlled clinical trials of the effects of a specialist nurse practitioner on short and long term diabetic outcomes were included in the review . DATA COLLECTION AND ANALYSIS Three investigators performed data extraction and quality scoring independently ; any discrepancies were resolved by consensus . MAIN RESULTS Six trials including 1382 participants followed for six to 12 months were included . Two trials were in adolescents . Due to substantial heterogeneity between trials a meta- analysis was not performed . Glycated haemoglobin ( HbA1c ) in the intervention groups was not found to be significantly different from the control groups over a 12 month follow up period . One study demonstrated a significant reduction in HbA1c in the presence of the diabetes specialist nurse/nurse case manager at 6 months . Significant differences in episodes of hypoglycaemia and hyperglycaemia between intervention and control groups were found in one trial . Where reported , emergency admissions and quality of life were not found to be significantly different between groups . No information was found regarding BMI , mortality , long term diabetic complications , adverse effects , or costs . REVIEW ER 'S CONCLUSIONS The presence of a diabetes specialist nurse / nurse case manager may improve patients ' diabetic control over short time periods , but from currently available trials the effects over longer periods of time are not evident . There were no significant differences overall in hypoglycaemic episodes , hyperglycaemic incidents , or hospital admissions . Quality of life was not shown to be affected by input from a diabetes specialist nurse/nurse case manager | [
"BACKGROUND Diabetic patients taking insulin often have suboptimal glucose control , and st and ard methods of health care delivery are ineffective in improving such control . This study was undertaken to determine if insulin adjustment according to advice provided by telephone by a diabetes nurse educator could lead to better glucose control , as indicated by level of glycated hemoglobin ( HbA1c ) . METHODS The authors conducted a prospect i ve r and omized trial involving 46 insulin-requiring diabetic patients who had poor glucose control ( HbA1c of 0.085 or more ) . Eligible patients were those already taking insulin and receiving endocrinologist-directed care through a diabetes centre and whose most recent HbA1c level was 0.085 or higher . The patients were r and omly assigned to receive st and ard care or to have regular telephone contact with a diabetes nurse educator for advice about adjustment of insulin therapy . RESULTS At baseline there was no statistically significant difference between the 2 groups in terms of HbA1c level ( mean [ and st and ard deviation ] for st and ard-care group 0.094 [ 0.008 ] and for intervention group 0.096 [ 0.010 ] ) , age , sex , type or duration of diabetes , duration of insulin therapy or complications . After 6 months , the mean HbA1c level in the st and ard-care group was 0.089 ( 0.010 ) , which was not significantly different from the mean level at baseline . However , the mean HbA1c level in the intervention group had fallen to 0.078 ( 0.008 ) , which was significantly lower than both the level at baseline for that group ( p Insulin adjustment according to advice from a diabetes nurse educator is an effective method of improving glucose control in insulin-requiring diabetic patients",
"OBJECTIVE To investigate whether monitoring and discussing psychological well-being in out patients with diabetes improves mood , glycemic control , and the patient 's evaluation of the quality of diabetes care . RESEARCH DESIGN AND METHODS This study was a r and omized controlled trial of 461 out patients with diabetes who were r and omly assigned to st and ard care or to the monitoring condition . In the latter group , the diabetes nurse specialist assessed and discussed psychological well-being with the patient ( with an interval of 6 months ) in addition to st and ard care . The computerized Well-being Question naire was used for this purpose . Primary outcomes were mood , HbA(1c ) , and the patient 's evaluation of the quality of diabetes care at 1-year follow-up . The number of referrals to the psychologist was analyzed as a secondary outcome . Intention-to-treat analysis was used . RESULTS The monitoring group reported better mood compared with the st and ard care group , as indicated by significantly lower negative well-being and significantly higher levels of energy , higher general well-being , better mental health , and a more positive evaluation of the quality of the emotional support received from the diabetes nurse . The two groups did not differ for HbA(1c ) or in their overall evaluation of the quality of diabetes care . In the monitoring condition , significantly more subjects were referred to the psychologist . CONCLUSIONS Monitoring and discussing psychological well-being as part of routine diabetes outpatient care had favorable effects on the mood of patients but did not affect their HbA(1c ) . Our results support the recommendation to monitor psychological well-being in patients with diabetes",
"The aim of the present study was to examine the effect of participation in a support group on self-assessed quality of life . Based on an initial self-report assessment of quality of life 25 people were allocated to 5 groups comprising 4 - 6 participants ( intervention group ) and 36 controls . The support groups met fort-nightly for 6 months and were facilitated by the investigator and a diabetic nurse specialist . Group processes were aim ed at alleviating distress and improve satisfaction with life and included installation of hope , imparting information and group cohesiveness . Both the intervention and control group completed the quality of life measure at the end of 6 months . There were no significant differences between the intervention and control group on background characteristics or quality of life pre-test scores . No significant differences were found between the intervention and control group on difference in pre and post-test scores , indicating that support group participation did not effect self-assessed quality of life . This finding may be due to method ological issues i.e. selection , sample size and the instrument used , the implementation of the intervention and /or the concept of quality of life as an outcome variable",
"PURPOSE The purpose of this study was to evaluate an intensive diabetes foot education program for veterans at high risk for foot ulcer . METHODS We invited 100 consecutive patients with diabetes from a Department of Veterans Affairs Medical Center clinic who were insensate to the Semmes-Weinstein 5.07 monofilament to participate in a foot care education program . Two sessions were conducted by a nurse diabetes educator 3 months apart . Multiple educational approaches were used to teach patients foot self-examination , foot washing , proper footwear , and encouragement in enlisting proper physician foot care . Knowledge and satisfaction with care was measured before and after each visit . RESULTS The 34 patients who attended both education sessions improved their foot care knowledge over the course of the program . After the second session , the mean improvement over baseline was 14 % . These patients also reported improved satisfaction with foot care ; mean improvement was 33 % . CONCLUSIONS An intensive education program improved the foot care knowledge and behavior of high-risk patients . Those who adhered to a foot care education program were more satisfied with their foot care than prior to the program . Ways to improve accessibility of education sessions must be explored",
"OBJECTIVE Hospitalized patients with diabetes have a prolonged length of stay in the hospital . We conducted a controlled prospect i ve r and omized feasibility study of the effects of a diabetes team ( a diabetes nurse educator and an endocrinologist ) on the length of stay and other outcomes of hospitalization in these patients . RESEARCH DESIGN AND METHODS A total of 179 hospitalized patients with diabetes were r and omly assigned to receive usual care supplemented with ( 85 patients ) or without ( 94 control patients ) a diabetes team intervention . Outcome measures included the length of stay , blood glucose control , and rates of readmission . RESULTS For the primary diagnosis of diabetes , the median length of stay was 5.5 days ( 95 % CI 4 - 8 days ) for patients who received diabetes team intervention and 7.5 days ( 5–11 days ) for the control patients ( NS ) . For the secondary diagnosis of diabetes , the median length of stay was 10.0 days ( 8–13 days ) in the intervention group and 10.5 days ( 8–13 days ) in the control group ( NS ) . One month after the team intervention was initiated , 75 % of patients in the intervention group were in good glycemic control , compared with 46 % in the control group . Readmissions at 3 months after discharge included 13 ( 15 % ) patients from the intervention group and 30 ( 32 % ) patients in the control group ( P = 0.01 ) . CONCLUSIONS R and omized controlled prospect i ve trials of clinical interventions in hospitalized patients with diabetes are feasible . Diabetes team intervention appears to reduce the hospital length of stay and to improve glycemic control . Team intervention significantly reduces the rate of recurrent hospitalization",
"This paper describes the development and evaluation of a computer-aided learning ( CAL ) program . The program was tested in a trial that involved 36 people with diabetes ; 20 received CAL lessons in diabetes management and 16 attended conventional diabetes classes conducted by diabetes educators . When measurements taken before and three months after the education were compared , both groups showed significant improvement in their knowledge ; the blood glucose levels of the CAL group were significantly lower but those of the conventional education group were higher . This means that the CAL program was as effective as conventional education in imparting knowledge but it was more likely to motivate people to control their glucose levels . The CAL program allows diabetes educators to spend less time on education in basic knowledge and to concentrate more on motivational and social factors that are important determinants of patient compliance . It can also benefit people with diabetes whose access to health professionals and /or conventional diabetes education is restricted",
"AIMS To evaluate the effectiveness and cost implication s of a hospital diabetes specialist nursing service . METHODS We conducted a prospect i ve , open , r and omized , controlled trial of st and ard in-patient care for adults with diabetes , with and without the intervention of a diabetes specialist nursing ( DSN ) service . The setting was a single UK university hospital . SUBJECTS were unselected patients referred to the hospital DSN service . Primary outcome measures were length of hospital stay and patterns of readmission ( frequency and time to first readmission ) . Secondary outcome measures were subjects ' diabetes-related quality of life , diabetes knowledge score , satisfaction with treatment , and GP and community care contacts following discharge . Costs were estimated from the hospital and published sources . RESULTS Median length of stay was lower in the intervention group ( 11.0 vs. 8.0 days , P Readmission rates were the same in the two groups ( 25 % ) , and mean time to readmission was similar in the two groups , although slightly less in the control group ( 278 vs. 283 days , P = 0.80 ) . The cost per patient for nursing input was 38.94 pounds sterling . However , when the reduced length of stay was accounted for , the intervention produced a mean cost per admission of 436 ponds sterling lower than that of the control group ( P = 0.19 ) . Patients in the intervention group were more knowledgeable regarding their diabetes and more satisfied with their care . CONCLUSIONS Diabetes specialist nurses are potentially cost saving by reducing hospital length of stay ( LOS ) . There was no evidence of an adverse effect of reduced LOS on re-admissions , use of community re sources , or patient perception of quality of care",
"OBJECTIVE We evaluated automated telephone disease management ( ATDM ) with telephone nurse follow-up as a strategy for improving diabetes treatment processes and outcomes in Department of Veterans Affairs ( VA ) clinics . We also compared the results with those of a prior ATDM trial conducted in a county health care system . RESEARCH DESIGN AND METHODS A total of 272 VA patients with diabetes using hypoglycemic medications were r and omized . During the 1-year study period , intervention patients received biweekly ATDM health assessment and self-care education calls , and a nurse educator followed up with patients based on their ATDM assessment reports . Telephone surveys were used to measure patients ' self-care , symptoms , and satisfaction with care . Outpatient service use was evaluated using electronic data bases and self-reports , and glycemic control was measured by HbA1c and serum glucose testing . RESULTS At 12 months , intervention patients reported more frequent glucose self-monitoring and foot inspections than patients receiving usual care and were more likely to be seen in podiatry and diabetes specialty clinics . Intervention patients also were more likely than control patients to have had a cholesterol test . Among patients with baseline HbA1c levels > or = 8 % , mean end-point values were lower among intervention patients than control patients ( 8.7 vs. 9.2 % , respectively ; P = 0.04 ) . Among intervention and control patients with baseline values > or = 9 % , mean end-point values were 9.1 and 10.2 % , respectively ( P = 0.04 ) . At follow-up , intervention patients reported fewer symptoms of poor glycemic control than control patients and greater satisfaction with their health care . CONCLUSIONS This intervention improved the quality of VA diabetes care . Intervention effects for most end points replicated findings from the prior county clinic trial , although intervention-control differences in the current study were smaller because of the relatively good self-care and health status among the current study 's enrollees",
"In patients with non-insulin-dependent diabetes mellitus ( NIDDM ) , the influence of knowledge about their disease on the treatment and control of the disease is not clear . We evaluated the efficacy of educational group meetings with NIDDM patients on improving their knowledge of the disease and on disease management . Fifty-one NIDDM patients were r and omly assigned to either intervention or control groups . The intervention group participated in courses of three weekly lessons presented by a physician , nurse , and dietitian once every 4 mo . The intervention and control groups were also followed once every 2 mo in the clinic by the same staff . Medical treatment remained unchanged during the study . After a 12-mo follow-up of the intervention group , no significant improvement in their knowledge of diabetes could be demonstrated . However , mean fasting and postpr and ial blood glucose levels and HbA1c improved significantly in comparison with the control goup . The same tendency was evident with the weight and lipoprotein profile . We conclude that educational group therapy can improve diabetes control in patients with NIDDM",
"OBJECTIVE To assess the quality of r and omization from reports of trials in a sample of specialist journals , and to compare those results with a similar assessment from a sample of general medical journals . DESIGN Evaluation of all 206 reports of parallel-group r and omized trials published in the 1990 and 1991 volumes of four journals of obstetrics and gynecology and of 81 reports of trials published during 1987 in four general medical journals . RESULTS Of the reports published in the specialist and in the general medical journals , only 32 % and 48 % , respectively , reported having used an adequate method to generate r and om numbers ; only 23 % and 26 % , respectively , contained information showing that steps had been taken to conceal assignment until the point of treatment allocation ; and merely 9 % and 15 % , respectively , described adequate methods of both sequence generation and allocation concealment . In those reports of trials that had apparently used unrestricted r and omization , the differences in sample sizes between treatment and control groups were much smaller than would be expected by chance , and that feature was more marked in the specialist journals . In reports of trials in which hypothesis tests had been used to compare baseline characteristics , only 2 % of tests reported in specialist journals and 4 % of tests reported in general journals were statistically significant , lower than the expected rate of 5 % . CONCLUSIONS Generating unbiased comparison groups requires proper r and omization , yet the reports in these specialist and general journals usually provided inadequate or unacceptable information . Additional analyses suggest that nonr and om manipulation of comparison groups and selective reporting of baseline comparisons may have occurred",
"OBJECTIVE To evaluate the effectiveness of a cluster visit model led by a diabetes nurse educator for delivering outpatient care management to adult patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS This study involved a r and omized controlled trial among patients of Kaiser Permanente 's Pleasanton , CA , center who were aged 16 - 75 years and had either poor glycemic control ( HbA1c > 8.5 % ) or no HbA1c test performed during the previous year . Intervention subjects received multidisciplinary outpatient diabetes care management delivered by a diabetes nurse educator , a psychologist , a nutritionist , and a pharmacist in cluster visit setting s of 10 - 18 patients /month for 6 months . Outcomes included change ( from baseline ) in HbA1c levels ; self-reported changes in self-care practice s , self-efficacy , and satisfaction ; and utilization of inpatient and outpatient health care . RESULTS After the intervention , HbA1c levels declined by 1.3 % in the intervention subjects versus 0.2 % in the control subjects ( P self-care practice s and several measures of self-efficacy improved significantly in the intervention group . Satisfaction with the program was high . Both hospital ( P = 0.04 ) and outpatient ( P adults with diabetes improved glycemic control , self-efficacy , and patient satisfaction and result ed in a reduction in health care utilization after the program",
"AIM The aim of our study was to describe investigate and association between improved glycaemic control on quality of life ( QoL ) during 1 year of treatment in a sample of 94 Type 2 diabetic patients referred for insulin therapy to an outpatient department ( OPD ) . Treatment was aim ed at achieving acceptable glycaemic control by means of maximizing oral therapy , if necessary switching over to insulin therapy , and information and education provided by a diabetes specialist nurse and dietitian . METHODS QoL was measured using a disease-specific ( Diabetes Health Profile ( DHP ) ) and a generic question naire ( R AND -36 ) . After 1 year the medical examination and QoL measurements were repeated . The association between 1-year changes in QoL and achievement of good metabolic control ( final glycosylated haemoglobin ( HbA1c ) mean HbA1c was reduced from 10.4 % to 7.8 % . Also QoL improved in the total group . Patients who achieved good glycaemic control after 1 year ( 61 % ) improved in a similar manner as the others . Patients switched over to insulin ( 65 % ) improved in a similar manner as the others , but at the final examination they experienced more problems with social functioning and pain . Patients with hyperglycaemic complaints at baseline ( 49 % ) improved more in QoL than those without , especially in physical functioning , vitality and health change , but at the final examination still scored lower on a majority of the DHP and R AND -36 dimensions . CONCLUSION Symptoms of hyperglycaemia predict the strength of an association between improvements of glycaemic control and",
"OBJECTIVE We evaluated the impact of automated telephone disease management ( ATDM ) calls with telephone nurse follow-up as a strategy for improving outcomes such as mental health , self-efficacy , satisfaction with care , and health-related quality of life ( HRQL ) among low-income patients with diabetes mellitus . RESEARCH DESIGN This was a r and omized , controlled trial . SUBJECTS Two hundred forty-eight primarily English- and Spanish-speaking adults with diabetes enrolled at the time of visits to a county health care system . INTERVENTION In addition to usual care , intervention patients received biweekly ATDM calls with telephone follow-up by a diabetes nurse educator . Patients used the ATDM calls to report information about their health and self-care and to access self-care education . The nurse used patients ' ATDM reports to allocate her time according to their needs . MEASURES Patient-centered outcomes were measured at 12 months via telephone interview . RESULTS Compared with patients receiving usual care , intervention patients at follow-up reported fewer symptoms of depression ( P = 0.023 ) , greater self-efficacy to conduct self-care activities ( P = 0.006 ) , and fewer days in bed because of illness ( P = 0.026 ) . Among English-speaking patients , those receiving the intervention reported greater satisfaction with their health care overall and with the technical quality of the services they received , their choice of providers and continuity of care , their communication with providers , and the quality of their health outcomes ( all P Intervention and control patients had roughly equivalent scores for established measures of anxiety , diabetes-specific HRQL , and general HRQL . CONCLUSIONS This intervention had several positive effects on patient-centered outcomes of care but no measurable effects on anxiety or HRQL",
"The effect of patient education on diabetic control in insulin-treated diabetic adults was studied in 77 subjects r and omized into two groups : intensive patient education ( group A ) and control ( group B ) . The subjects in group A received intensive patient instruction , both individually and in small groups , from a team of physicians , teaching nurses , and a dietitian . The patients in group B received a short instruction course consisting mainly of printed material . A highly significant improvement in diabetic control was observed in both groups immediately after the education programs , with gradual return to the original level during the following 3–6 mo . No difference was observed between the two groups in any of the measured parameters during the 18-mo investigation . Factors related to good control during the study included the length of school education , the quality of the control at the beginning of the study , and the high degree of self-confidence and lack of signs of anxiety in the psychological tests . The results demonstrate that the effects of educational programs are of limited value if they do not lead to permanent changes in attitudes and motivation , which are critical factors affecting long-term diabetic control",
"AIM OF THE STUDY Assessment of effects on quality of care , in terms of patient outcomes , when tasks in the care for out patients with stable type 2 diabetes are transferred from internist to nurse specialist and from outpatient clinic to general practice . BACKGROUND For the management of chronic diseases with a high prevalence and requiring current monitoring , it is suggested that substitution of care may be an appropriate solution to safeguard high quality care . DESIGN AND METHODS A 12-month nonequivalent control group design was used . General practitioners ( GPs ) referring diabetes patients to the University Hospital Maastricht were asked to choose for the traditional model or the nurse specialist model . Informed consent was obtained from patients with stable diabetes type 2 attending these practice s. All patients received care according to the model chosen by their GP . Identified outcomes were : clinical status , health status , self-care behaviour , knowledge of diabetes , patient satisfaction , and consultation with care-providers . RESULTS In the control group ( n=47 ) no patients were treated with oral hypoglycaemic agents ( OHA ) only . The control group was compared with an intervention subgroup ( n=52 ) also without patients receiving OHA only . Clinical data were available for all patients . Patients without complete data from question naires had better mean concentration of HbA1c than patients with complete data ( P=0.004 ) . The traditional care model and the nurse specialist model achieved equal outcomes , while glycaemic control of patients in the nurse specialist model improved ( from 8.6 % to 8.3 % ) but deteriorated in the traditional model ( from 8.6 % to 8.8 % ; P-value between groups=0.001 ) . CONCLUSIONS The model with nurse specialists taking on roles and tasks beyond those traditionally regarded as their remit as well as new ones , is effective for the care of stable diabetic out patients",
"OBJECTIVE This study was undertaken to determine the health and cost effects of using home care to treat newly diagnosed Type I diabetic children rather than traditional inpatient hospital care . There had been no well- design ed evaluations of home care for such children , and very few for children with other health conditions . METHODS Sixty-three children seen at the Montreal Children 's Hospital were r and omly assigned at diagnosis to home care or traditional inpatient care . The children in the former group were discharged once their metabolic condition stabilized ; insulin adjustments and teaching were done in their homes by a trained nurse . The children in the latter group remained hospitalized for insulin adjustments and teaching . All were followed for 24 months . The cost effects were estimated using hospital and parental data . RESULTS Social costs were only $ 48 higher with home care . It had little effect on social costs , because the increased costs of health care services with home care ( $ 768 ) were largely offset by parental cost savings ( $ 720 ) . Home care improved the children 's metabolic outcomes without adversely affecting their psychosocial outcomes . CONCLUSIONS Using home care to reduce hospital stays for children with newly diagnosed Type I diabetes improved the children 's health outcomes without significantly increasing social costs",
"It has been suggested that much effort expended in teaching diabetic diets is ineffective and wasteful . We have tested a different system by r and omly allocating 75 newly diagnosed obese Type 2 diabetic patients to usual ‘ unstructured ’ clinic care or to group education by diabetes specialist nurses and a dietitian . Patients allocated to group education attended five 90‐min group sessions during the first 6 months . Six months after diagnosis they had lost more weight ( median ( 95 % CI ) , 7 ( 5.5–9 ) vs 2 ( 1–5 ) kg , p were better controlled ( HbA1 : 7.5 ( 7.0–8.1 ) vs 9.5 ( 8.7–10.4 ) % , p the difference in weight loss was less ( 5.5 ( 4–6.5 ) vs 3 ( 2–4 ) kg , p had a fasting blood glucose less than 7.0 mmol l−1",
"The purpose of this study was to evaluate the effrcacy of using a telecommunication system to assist in the outpatient management of pediatric patients with insulin- dependent diabetes . Metabolic control , patients ' psychosocial status , family functioning , perceived quality of life , patterns of parental/child responsibility for daily diabetes maintenance , and nursing time-on-task were evaluated . One hundred six pediatric patients ( mean age= 13.3 years ) were r and omly assigned to an experimental or control outpatient clinic for 1 year . Experimental subjects transmitted self-monitoring blood glucose data by modem to the hospital every 2 weeks . Transmitted data were review ed by nurse practitioners who telephoned subjects to discuss regimen adjustments . Control subjects received st and ard care with regimen adjustments made by physicians . There were no significant between-group differences for metabolic control , rates of hospitalization or emergency-room visits , psychological status , general family functioning , quality of life , or parent-child responsibility . A significant decrease was noted in nursing time-on-task for experimental subjects",
"Background . Newly diagnosed insulin-dependent diabetic children are most often admitted to hospital for education and insulin management and subsequently followed in outpatient clinics or office setting s. However , most could be managed at home , given adequate family and health care team support and subsequent follow-up facilitated by home-based nursing intervention . We conducted a r and omized trial of clinical , psychosocial , and cost effects of home-based management in a 2-year follow-up study of newly diagnosed diabetic children . Methods . Sixty three patients were r and omly assigned to traditional hospitalization and outpatient follow-up ( hospital-based group ) or home management ( home-based group ) . Treatment differences between the two groups consisted of duration of initial hospital stay , site and timing of initial teaching , and nature and extent of subsequent nursing follow-up . Metabolic control was assessed by means of quarterly glycosylated hemoglobin measurements for 24 months and then at 36 months . Diabetes-related adverse events , knowledge of diabetes , adherence to the diabetes regimen , psychosocial impact , and social ( total ) costs incurred were assessed for 24 months . Findings . Glycosylated hemoglobin concentrations were significantly lower in the home-based group at 12 to 24 months and at 36 months . Both groups had comparable numbers of diabetes-related adverse events . There were no significant group differences in psychosocial impact . Parents in the home-based group spent significantly fewer hours on diabetes care and incurred significantly lower out-of-pocket expenses during the 1st month . Health care sector costs were significantly higher . Hospital costs were $ 889 higher , and government costs $ 890 higher per child . Social ( total ) costs were only $ 48 higher per case ( NS ) with home care when parents ' time was valued at $ 11.88 per hour . Interpretation . Home-based management for newly diagnosed diabetic children can result in better metabolic control and similar psychosocial outcomes compared with traditional hospital- and clinic-based care without notable effects on social ( total ) costs",
"AIMS To ascertain the effect of routine review by a diabetes nurse advisor on length of stay for medical and surgical in patients with diabetes . METHODS In patients with diabetes were identified prospect ively from January 1997 until December 1998 ( 792 in 1997 and 819 in 1998 ) . A new post of diabetes nurse advisor was introduced in January 1998 to optimize diabetes management . Length of stay was calculated retrospectively from hospital computer records . RESULTS Median length of stay in 1997 was 11 days in medicine and 8 days in surgery . In 1998 , the nurse advisor made 1936 visits to 819 patients ; median length of stay fell to 8 days in medicine and 5 days in surgery ( P Bed occupancy by patients with diabetes fell from 6.8 to 4.0 % . Mean length of stay across the hospital remained unchanged . CONCLUSIONS The introduction of a ward-based diabetes nurse advisor was associated with significant reductions in length of stay in in patients with diabetes . Since this study was not a r and omized study , other factors may have contributed to this change . However , the consistency of the reduction across specialities suggests the post itself had an important effect",
"OBJECTIVE To determine whether a 6-month home-based intervention program in adolescents with poorly controlled diabetes improves metabolic control and whether benefits are maintained after the intervention . RESEARCH DESIGN AND METHODS Adolescents with a mean HbA1c of > 9.0 % over the preceding 12 months received either routine care in a diabetes clinic and an ambulatory intervention for 6 months ( n = 37 ) or routine care only ( n = 32 ) . A diabetes educator provided monthly home visits and weekly phone contact to educate and support the adolescents in setting goals for insulin adjustment , blood glucose monitoring , and target blood glucose range . There was no systematic change in the frequency of insulin injections . After the intervention , there was a 12-month follow-up when the intervention and control groups both received only routine care . Outcome measures were HbA1c and Diabetes Knowledge Assessment ( DKN ) . RESULTS During the intervention , mean HbA1c fell ( baseline : 11.1 + /- 1.3 % , 6 months : 9.7 + /- 1.6 % ; P = 0.0001 ) and mean knowledge scores increased ( P = 0.0001 ) in the intervention group but not in control subjects . However , this improvement in HbA1c and increase in knowledge was not maintained in the intervention group at 12- and 18-month follow-up assessment s. Parents ' knowledge scores also improved significantly from baseline levels in the intervention group at 6 and 12 months ( P = 0.001 , P = 0.005 , respectively ) . CONCLUSIONS An ambulatory program improves metabolic control and knowledge in adolescents with poorly controlled type 1 diabetes ; however , it is effective only while the intervention is maintained",
"OBJECTIVE To describe the methods used to implement intensive and conventional therapies in the Diabetes Control and Complications Trial ( DCCT ) and the metabolic results that occurred with the different treatment regimens . RESEARCH DESIGN AND METHODS The DCCT was a controlled clinical trial that demonstrated the beneficial effect of intensive therapy on the long-term complications of insulin-dependent diabetes mellitus ( IDDM ) . A total of 1,441 volunteers with IDDM , aged 13–39 , from 29 centers in the U.S. and Canada , were r and omly assigned to conventional or intensive diabetes therapy . Intensive therapy , which used multiple daily injections ( MDI ) of insulin ( ≥3 injections/day ) or continuous subcutaneous insulin infusion ( CSI1 ) , was implemented by a team that included diabetes nurses , dietitians , behavioral experts , and diabetologists . Volunteers in the intensive treatment group could use MDI or CSII , based on patient and clinic preference , and could switch between therapies over the course of the study . The volunteers were followed for a mean of 6.5 years ( range 3–9 years ) . RESULTS A detailed analysis of implementation of the two treatments indicates that intensive and conventional treatment subjects adhered to their respective insulin injection regimens > 97 % of the time . Adherence to other elements of intensive treatment was similarly high and result ed in median HbAlc values between 6.7 and 7.2 , compared with 8.7–9.2 with conventional therapy , over the course of the study . Severe hypoglycemia occurred three times more often in intensively treated subjects . Although subjects on intensive treatment were not r and omly assigned to MDI or CSII , we compared those subjects who used either of these methods for > 90 % of the study time . CSIIy-treated patients maintained a mean HbAlc of 6.8 vs. 7.0 in MDI-treated subjects during the trial ( P ) . The frequency of hypoglycemia with coma and seizure and diabetic ketoacidosis was modestly higher with CSII than with MDI . CONCLUSIONS Intensive therapy was implemented successfully in the DCCT . The detailed description herein will serve to facilitate translation of the DCCT results to the clinical setting",
"Eighty consecutive newly diagnosed non-insulin-dependent diabetic patients were r and omly allocated into two groups to compare two different patient education regimens . One group received individual dietary instructions by a nurse and the other a short , written leaflet given by a doctor . The principal aim of the dietary instructions was weight reduction . A significant weight loss and improvement in the control of diabetes occurred in both groups , and these changes were similar in the two groups . At the end of one year 's follow-up , however , only 25 % of the patients were satisfactorily controlled ( fasting blood glucose less than or equal to 6.0 mmol/l ) . The degree of weight loss correlated only weakly with the improvement in the metabolic control . The degree of obesity and insulin secretion capacity as measured at the beginning of the study did not predict the improvement of glycaemic control during the study . At the end of the study a significant improvement was observed in serum lipids of patients with good control ( fasting blood glucose less than or equal to 6.0 mmol/l ) or weight loss ( greater than 5 kg ) . In conclusion , both brief , written and individual dietary instructions induced a significant weight loss as well as improved glucose and lipid metabolism in newly diagnosed non-insulin-dependent diabetic patients , but satisfactory metabolic control was achieved only in a minority of the patients",
"OBJECTIVE To examine baseline renal screening practice s and the effect of nurse case management of patients with diabetes in a group model health maintenance organization ( HMO ) . RESEARCH DESIGN AND METHODS We performed both 1-year retrospective and 1-year prospect i ve studies of renal assessment practice s and ACE inhibitor usage in a cohort of 133 diabetic patients enrolled in a r and omized controlled trial of a diabetes nurse case management program in a group model HMO . In accordance with American Diabetes Association recommendations , urine dipstick and quantitative protein and microalbuminuria testing rates were calculated . RESULTS At baseline , 77 % of patients were screened for proteinuria with dipsticks or had quantitative urine testing . Of patients with negative dipstick findings , 30 % had appropriate quantitative protein or microalbumin follow-up at baseline . Baseline ACE inhibitor usage was associated with decreased follow-up testing ( relative risk = 0.47 ) . Nurse case management was associated with increased quantitative protein or or microalbumin testing and increased follow-up testing ( relative risk = 1.65 and 1.60 , respectively ) . CONCLUSIONS We found a higher degree of adherence to recommendations for renal testing than has been reported previously . Nurse case management intervention further increased renal screening rates . The inverse association between ACE inhibitor usage and microalbumin testing highlights a potentially ambiguous area of current clinical pathways",
"BACKGROUND This study was done to determine the efficacy and ease of administration of education/behavior modification classes , provided by a nurse and a dietitian in a primary care clinic for improving control of type 2 diabetes mellitus . METHODS Patients were divided r and omly into two groups . Eighteen patients completed 6 months of structured , office-based classes , and 20 similar patients served as control subjects . All were patients of the same group practice and had their usual office visits . Glycemic control , lipid levels , body weight , knowledge about diabetes , medication requirements , and symptoms were monitored during the 6 months , with follow-up at 12 months . RESULTS At the end of 6 months , the intervention group had significant reductions in mean fasting blood glucose , glycosylated hemoglobin , total cholesterol , and low-density lipoprotein cholesterol ( LDL-C ) values . Their mean body weight was significantly reduced at 12 months , and their knowledge of diabetes was improved . Control patients had significant improvement only in glycosylated hemoglobin and body weight at 6 months . Minimal physician time was required . CONCLUSION The education/behavior modification program was clinical ly worthwhile , and it was easy to administer",
"The Diabetes Control and Complications Trial ( DCCT ) and the Kumamoto study [ 1 , 2 ] showed that near-normal glycemic control reduces the development and progression of microvascular and neuropathic complications by approximately 50 % in type 1 and type 2 diabetes mellitus . Additional analyses [ 3 - 5 ] indicate that therapy to achieve near normalization of blood glucose levels is cost-effective compared with other treatments . Thus , the American Diabetes Association has recommended that all persons with diabetes attempt to achieve near normalization of blood glucose levels [ 6 ] . This recommendation is not routinely followed in medical practice . In a 1989 national survey of physician practice behaviors in the United States , 64 % of physicians agreed that achieving target HbA1c values is very important but only 18 % reported that they ordered HbA1c tests every 2 to 3 months for patients with type 1 diabetes [ 7 ] . Although 98 % agreed that patient education improves glucose control , only 55 % reported that they routinely used a dietitian or a diabetes educator in patient care . Studies indicate that bringing clinical practice into line with scientific knowledge can be difficult . Methods used to achieve diabetes control in clinical trials are re source intensive . The American Diabetes Association currently recommends that patients with diabetes see their primary care physicians two to four times per year . Data from the National Health Interview Survey , a nationally representative survey [ 8 ] , indicate that most patients with diabetes are seen by nonspecialists and that 69 % of physician visits last less than 15 minutes . Algorithms for diabetes care exist but may be complex and difficult for physicians to follow , given patient load , diversity of patients seen , lack of information systems , and time constraints . Simple , low-cost methods of translating guidelines into clinical care are required . One solution may be to make greater use of personnel other than physicians . Nurse case management was an integral part of intensive therapy in the DCCT and has proven to be effective in reducing smoking and cholesterol levels after acute myocardial infa rct ion [ 3 , 9 ] . A nonr and omized study [ 10 ] of more than 700 patients with diabetes in a health maintenance organization suggests that nurse case management may be effective in improving metabolic control . Other studies [ 11 , 12 ] show a strong association between algorithm-directed nurse interventions and improved glycemic control . To our knowledge , no r and omized , controlled clinical trial of nurse case management in diabetes has yet been published . In a 12-month r and omized , controlled trial , we compared a nurse case management model of diabetes care with usual diabetes management in a primary care setting . Methods Patients Our study was approved by the institutional review board of the Prudential Center for Health Care Research , and all patients gave written informed consent . Participants were recruited from two of the largest clinics within the Jacksonville Health Care Group , which is the largest provider of primary care services for the Prudential HealthCare HMO plan of Jacksonville , Florida . The Jacksonville Health Care Group is a group of 43 primary care physicians who provide care in eight clinics to more than 75 000 Prudential HealthCare plan members . Potential study participants were identified through a data base used to support quality -improvement activities . Prudential HealthCare HMO members who had diabetes were included in the data base if they had visited a physician for diabetes ( International Classification of Diseases , 9th Revision , codes 250.0 to 250.9 ) , had had a hospital cl aim processed for diabetes , had been seen by the utilization management nurse , or had been referred to an ophthalmologist for a diabetic retinal examination . This data base is up date d regularly . A list with each member 's name , address , telephone number , medical record number , member identification number , age , sex , physician , and clinic was generated by merging the data from the data base with enrollment information . In addition , a list of members who may have had diabetes was created by using pharmacy data . Adult members with diabetes who were potential study participants each received a recruitment call and were invited to schedule an appointment with a research assistant to discuss participation in the study . We made a total of 14 calls at different times and on different days before coding a member as unavailable . After consent was given and the eligibility assessment was completed , baseline information was obtained and an HbA1c test was ordered if the result of one given within the previous 60 days was not available . Patients were ineligible for the study if they had a recent HbA1c value less than 7.0 % ; had uncontrolled hypertension ( blood pressure > 180/110 mm Hg ) ; had unstable angina ( class 4 ) ; had had a myocardial infa rct ion in the past 3 months ; had had two or more episodes of seizures ; had alcoholism or drug abuse documented in the chart ; had late-stage complications of diabetes or other chronic conditions , such as severe immunodeficiency or cirrhosis ; were pregnant or were planning to become pregnant in the next 12 months ; or were unable to perform self-management . Patients were r and omly assigned in blocks to either the nurse case management ( intervention ) group or the usual care group . R and omization was based on a 1:1 allocation ratio and a block size of three . Each block contained six patients , three in each study group . This r and omization scheme ensured that the desired allocation ratio-one intervention patient to one usual care patient-was maintained after sequential enrollment of every sixth patient . Outcome Measures Change in HbA1c value was the primary outcome measure . Decreased HbA1c values correlate directly with reduced risk for diabetes-related microvascular and neuropathic complications in type 1 and type 2 diabetes [ 1 , 3 ] . We also assessed health-related quality of life by using four generic questions developed by the Centers for Disease Control and Prevention for the Behavioral Risk Factor Surveillance System ( BRFSS ) [ 13 , 14 ] . These questions evaluate key conceptual domains of health-related quality of life : 1 ) patient-perceived general health status , 2 ) patient-perceived physical dysfunction during the previous 30 days , 3 ) patient-perceived mental dysfunction during the previous 30 days , and 4 ) patient-perceived functional incapacity during the previous 30 days for either mental or physical reasons . The BRFSS quality -of-life measures have been vali date d in a national sample of adults in the United States [ 15 ] . Patient-perceived health was found to be a good proxy indicator for chronic disease conditions . The other three domains further characterize general health functioning and quality of life [ 15 ] . In this analysis , we report findings related to the patient-perceived general health status domain . Intervention and Follow-up The nurse case manager was a registered nurse and a certified diabetes educator . She was trained to follow a set of detailed management algorithms under the direction of a board-certified family medicine physician and an endocrinologist who were responsible for all diabetes management decisions for patients in the intervention group but were not primary care providers for these patients . The algorithms were specific for type of diabetes and were developed by a multidisciplinary team on which endocrinology , family medicine , nursing , pharmacy , health services research , and epidemiology were represented . The algorithms progressively moved a patient toward improvement of glycemic control through adjustments in medication , meal planning , and reinforcement of exercise ( Figure 1 ) . Figure 1 . Algorithm for management of type 2 diabetes mellitus . Patients assigned to receive nurse case management met with the nurse for an initial assessment , were instructed about a blood glucose monitoring schedule , and returned for a follow-up visit 2 weeks later . The initial visit with the nurse averaged 45 minutes . At the 2-week follow-up visit , the nurse review ed the patient 's blood glucose log ; explained the algorithm step to which the patient had been assigned ; and used this information as the baseline for subsequent medication adjustments , meal planning , and exercise reinforcement . Patients receiving nurse case management were also referred to a 5-week , 12-hour diabetes education program that included individual counseling by a dietitian , individual counseling by an exercise therapist , and group diabetes education classes . Subsequent in-person follow-up visits occurred quarterly . Patients in the nurse case management group who were taking insulin received weekly follow-up telephone calls . After the nurse review ed the blood glucose log and discussed glucose values with the patient , medication regimens were adjusted as needed and meal planning and exercise were reinforced . Patients treated with oral agents or diet and exercise received follow-up telephone calls every 2 weeks . The nurse case manager met at least biweekly with the family medicine physician and the endocrinologist to review patient progress , medication adjustments , and other issues related to diabetes care . All medication adjustments or changes were communicated to the patients ' regular primary care physicians . Patients assigned to receive usual care were given blood glucose meters and strips , were encouraged to discuss enrollment in the diabetes education class with their physicians if they had not done so in the past year , and continued to receive diabetes care and follow-up from their primary care physicians . The 5-week diabetes education program is a st and ard , free-of-charge benefit for all HMO members with diabetes . All Jacksonville Health Care Group primary care physicians participate in an annual diabetes care seminar and undergo regular peer review of their adherence to published diabetes care st and ards . Tests to",
"OBJECTIVE This study compared the effect of cognitive analytic therapy ( CAT ) , a focused time-limited psychotherapy , and diabetes specialist nurse education ( DSNE ) in a controlled trial of 26 chronically poorly controlled adult type I patients . RESEARCH DESIGN AND METHODS Patients were r and omized to either 16 sessions of CAT ( treatment ) or 14–18 sessions of DSNE ( control ) . Pre- and post-treatment blood glucose control ( HbA1 ) , interpersonal difficulties , and diabetes knowledge were measured before and up to 9 months after treatment was completed . RESULTS Although HbA1 levels improved in the DSNE group , at the end of treatment ( mean fall 1.2 % , P = 0.004 ) this was not maintained ; so by the 9-month follow-up , the overall net fall was limited to 0.9 % ( P = 0.03 vs. entry value ) . There were no significant improvements in interpersonal difficulties in DSNE subjects at any retest point ( P > 0.05 ) . In contrast , glycemic control and interpersonal difficulties both improved after CAT . In contrast to DSNE , this improvement continued so that at the 9-month follow-up visit , the changes were significant ( mean fall in HbA1 = 2 % , P = 0.002 and P = 0.03 for the Inventory of Interpersonal Problems [ IIP ] scores ) . CONCLUSIONS These results suggest that although there is no statistical difference between CAT and DSNE , the effects of CAT produce a more prolonged effect on glycemic control . If psychological difficulties underlying problems with self-care in a type I population are addressed , then improvements in diabetes control are likely to continue",
"PURPOSE We sought to evaluate the effect of automated telephone assessment and self-care education calls with nurse follow-up on the management of diabetes . SUBJECTS AND METHODS We enrolled 280 English- or Spanish-speaking adults with diabetes who were using hypoglycemic medications and who were treated in a county health care system . Patients were r and omly assigned to usual care or to receive an intervention that consisted of usual care plus bi-weekly automated assessment and self-care education calls with telephone follow-up by a nurse educator . Outcomes measured at 12 months included survey-reported self-care , perceived glycemic control , and symptoms , as well as glycosylated hemoglobin ( Hb A1c ) and serum glucose levels . RESULTS We collected follow-up data for 89 % of enrollees ( 248 patients ) . Compared with usual care patients , intervention patients reported more frequent glucose monitoring , foot inspection , and weight monitoring , and fewer problems with medication adherence ( all P -0.03 ) . Follow-up Hb A , , levels were 0.3 % lower in the intervention group ( P = 0.1 ) , and about twice as many intervention patients had Hb A1c levels within the normal range ( P = 0.04 ) . Serum glucose levels were 41 mg/dL lower among intervention patients than usual care patients ( P = 0.002 ) . Intervention patients also reported better glycemic control ( P = 0.005 ) and fewer diabetic symptoms ( P symptoms of hyperglycemia and hypoglycemia . CONCLUSIONS Automated calls with telephone nurse follow-up may be an effective strategy for improving self-care behavior and glycemic control , and for decreasing symptoms among vulnerable patients with diabetes",
"The effectiveness of an enhanced preparation intervention was compared with the staiidard preparation intervention for accuracy in overnight urine specimen collection s. The sample consisted of 179 individuals with type I insulin-dependent diabetes mellitus ( IDDM ) . Subjects were assigned r and omly to an enhanced or st and ard preparation group . The enhanced preparation included written instructions , a reminder to post instructions in the bathroom , a toilet seat cover with a reminder to save urine , and a nurse-initiated telephone call to review the instnlctions . The st and ard preparation included written instructions and a telephone number to call with any questions . For subjects without previous collection experience , significantly fewer inaccurate collection s were reported in the enhanced preparation group than in the st and ard group ( x2 = 4.61 , P collection accuracy between enhanced and st and ard groups for subjects with collection experience ( x 2 = .4598 , P>.05 )",
"The purpose of this study was to evaluate the efficacy and feasibility of a newly developed diabetes patient education program consisting of a three-day hospitalization and a six-month follow-up by telephone counseling for patients with mild type 2 diabetes or impaired glucose tolerance ( IGT ) by a r and omized controlled trial ( RCT ) method . Fifty-two patients with mild type 2 diabetes or IGT ( HbAlc were r and omly assigned to either an intervention group or a control group . The current care was continued for the control group and the new education program was provided in addition to the current care for the intervention group . Changes in weight , blood glucose in a 75g-oral glucose tolerance test ( 75g-OGTT ) , and HbAlc were measured in June 1997 as baseline data and again in Dec. 1997 . Scores for knowledge of diabetes , dietary habits , physical activity , health practice index , diabetes quality of life ( DQOL ) , and self-efficacy were also obtained . After six months , the intervention group showed a statistically significant weight loss and blood glucose reduction in the 75g-OGTT test , but the control group did not . A significant improvement in lifestyle was observed in the intervention group , especially in terms of dietary habits and physical activity . The knowledge test scores increased in both groups . There were no significant differences in HbAlc , DQOL , or self-efficacy between the two groups . The results of this study show that the combination of a three-day hospitalization and a six-month follow-up by telephone counseling is effective in metabolic control and improvement of lifestyle for patients with mild type 2 diabetes or IGT . The reasons for the effectiveness were considered to be that l)changes in lifestyle were based on autonomous decision-making ; 2)regular , consistent counseling was provided by the nurse in charge of each patient ; 3)extended follow-up is more effective than initial education in preventing a rebound of weight or metabolic control",
"Home health nurses provided individualized instruction in diabetes self-care within the home environment of 393 diabetic individuals . Each subject was r and omly assigned to either the intervention ( those receiving home teaching ) or control ( those not receiving home teaching ) group . At 6 mo postenrollment , intervention subjects showed significantly greater self-care knowledge and skills than control subjects , although the actual differences between the two groups in terms of self-care skills were probably too small to have any practical meaning . The primary objective of the study , which was the reduction of the number of preventable diabetes-related hospitalizations ( ketoacidosis , ketotic coma , nonketotic coma , insulin reaction , and diabetes out of control ) , was not achieved ; no differences between the groups were noted after 12 mo of follow-up . Similarly , length of hospital stay , foot problems , emergency room and physician visits , and sick days were roughly equivalent in both groups during the follow-up year . These results suggest that , in the absence of concurrent changes in the health-care delivery system and strategies for influencing attitudes toward self-care , education alone is ineffective",
"This study tested the hypothesis that follow-up intervention ( by telephone calls and home visit ) affects compliance in patients with non-insulin-dependent diabetes mellitus ( NIDDM ) . Sixty NIDDM patients were r and omly assigned to two groups — a control group , which received the st and ard protocol ( 3-day educational program and a review session 1 month after the program ) ; and an intervention group , which received the st and ard protocol as well as a series offour telephone calls and one home visit by a registered nurse over a 3-month period . Compliance to prescribed regimens was determined by analyzing three sets of data : changes in pre- to post study glycosylated hemoglobin ( HbA1c ) values ; changes in pre- to post study weight ; and frequency with which self-monitoring of blood glucose ( SMBG ) was practice d. Results showed that SMBG practice was significantly better for the intervention group . No significant differences were seen in post study HbA 1c values and weight changes between the two groups . Follow-up inter vention by telephone calls and home visit can enhance patient compliance to certain aspects of the prescribed diabetes management plan",
"Given that 14 million Americans have diabetes [ 1 ] , the common complications of this disorder , such as foot ulcers and lower extremity amputations , are of major concern to the medical community . Approximately 20 % of all diabetic patients hospitalized in the United States are admitted because of foot complications [ 2 , 3 ] . Furthermore , about 50 % of all nontraumatic amputations in the United States are done in patients with diabetes [ 1 , 4 ] . This proportion equates to about 55 000 amputations a year [ 1 ] or 59.7 amputations for every 10 000 persons with diabetes [ 5 ] . Patients who undergo an amputation are at greater risk for a second similar procedure on either the same or the other leg [ 6 , 7 ] . Yet , it has been estimated that about one half of the amputations in patients with diabetes , or about one fourth of the total amputations done in the United States , are preventable [ 1 , 4 ] . Recently , the focus has been on preventive strategies that minimize foot damage in diabetic patients and thereby reduce the rates of ulcers and amputations . These preventive strategies are based on two observations : first , that simple efforts on the part of the health care provider or patient can reduce the likelihood of subsequent amputation due to diabetes-associated foot disease [ 8 ] ; and second , that many of these simple procedures are not being systematic ally applied by health care providers or patients [ 9 ] . For example , studies indicate that physicians infrequently examine the feet of patients with diabetes [ 9 , 10 ] . Also , most patients with diabetes do not engage in simple foot-care assessment s to identify lesions requiring early treatment [ 11 ] . Preventive strategies are not systematic ally applied for several reasons : First , patients may not be aware of foot-care procedures or how to do them , or they may not believe that such procedures can make a difference ; second , podiatry and orthopedics services that could assist in foot salvage in diabetic patients may not be available ; and , finally , the health care system may make it difficult for patients or health care providers to examine the feet of patients with diabetes [ 10 ] . Several uncontrolled studies found that implementation of improved foot-care programs can significantly reduce lower extremity complications in patients with diabetes ; these studies showed a 44 % to 85 % reduction in the rate of lower extremity amputations [ 4 , 12 - 14 ] . A recent casecontrol study also supports the implementation of preventive strategies , such as foot care , use of protective footwear , and aggressive treatment of foot infection by patients or health care providers , to decrease the risk for lower extremity amputation [ 15 ] . The intervention in our study was design ed to reduce the prevalence of risk factors for lower extremity amputations in patients with noninsulin-dependent diabetes and involved the three major elements of a prevention program : the patient , health care providers , and the health care system . Specifically , we did a r and omized , controlled trial to determine whether a comprehensive foot-care intervention could improve patients ' knowledge and performance of appropriate foot care ; increase the number of referrals to specialty clinics such as the podiatry clinic ; increase the frequency of foot examinations by health care providers and the documentation of risk factors in the medical record ; and improve short-term patient outcomes such as skin and nail conditions known to be risk factors for ulcers and amputations . Methods Setting Our study , the design of which is summarized in Figure 1 , was done from April 1989 to March 1991 in the academic general medicine practice of the Regenstrief Health Center in Indianapolis , Indiana [ 16 ] . The practice is subdivided into four primary care teams ( labeled A , B , C , and D ) , each with its own nursing and clerical staff . Each team sees patients for eight half-day sessions per week , with each session staffed by one or two faculty internists and two to four housestaff . Teams A and C were r and omly assigned to the intervention group ; teams B and D were assigned to the control group . Previous studies in which this method of r and omization was used have shown no baseline interteam differences in patient characteristics and physician practice behavior and no effect of the team on the study outcome [ 16 - 19 ] . Figure 1 . Summary of the study design . Patient Identification and Recruitment The computerized Regenstrief Medical Record System [ 20 ] was used to identify approximately 3000 patients with noninsulin-dependent diabetes , as well as the date and time of their next appointment . Only patients with noninsulin-dependent diabetes who were seen at least two times in the preceding year by the same provider were included in the study . Additional criteria for inclusion were as follows : an age greater than 40 years ; a diagnosis of diabetes after 30 years of age ; a diagnosis of diabetes based on National Diabetes Data Group criteria [ 21 ] or the presence of disease requiring medication for the control of hyperglycemia ; an intention to obtain care at the general medicine practice for the next 2 years ; and a body weight that was either ideal or heavier than ideal . Exclusion criteria included pregnancy ; major psychiatric illness , including dementia ; terminal illness likely to cause death within 1 year ; renal failure ( serum creatinine > 440 mol/L ) ; previous bilateral amputations above or below the knee ; or an inability to provide any self-care . Patients of investigators involved in the protocol were also excluded from the study . Of the 728 eligible patients , 244 refused to participate , 89 enrolled in the study but failed to keep their appointments for assessment , and 395 were assessed by trained nurse-clinicians . Of the 395 patients assessed , 352 ( 89 % ) completed the study ; 43 patients ( 11 % ) did not complete the study for the following reasons : death ( 11 patients ) ; change of residence ( 15 patients ) ; illness ( 6 patients ) ; transportation problems ( 3 patients ) ; and miscellaneous reasons ( 8 patients ) . Patient Assessment Sample s for determining fasting plasma glucose , cholesterol , triglyceride , high-density lipoprotein , hemoglobin A1C , and C-peptide levels were obtained from enrolled patients and immediately transported to a certified laboratory for analysis . Patients gave a history and had a physical examination at study entry and approximately 1 year later ( mean , 11.8 1.5 months ) . These examinations focused on risk factors for amputation and were administered by two trained nurse-clinicians who were blinded to the patients ' experimental conditions . Foot-related data derived from the history and physical examination included the patient 's self-reported foot-care behaviors ; the quality of the patient 's examination of his or her feet ; the severity of any foot lesions ; and the presence of musculoskeletal abnormalities , dermatologic conditions , peripheral vascular disease , and peripheral neuropathy ( the neuropathy assessment included quantitative measures of pressure and temperature sensation ) . Patients were question ed about their regular foot-care routine and were asked to show how they examined their feet . During this self-examination , nurse-clinicians observed whether patients ' scrutinized the toenails , the soles of the feet , and the area between toes . Musculoskeletal and dermatologic abnormalities were assessed using st and ard definitions of findings such as callus , hammer toe , and Charcot foot [ 3 , 22 ] . The nurse-clinicians palpated the dorsalis pedis , posterior tibial , and femoral pulses bilaterally in their assessment for peripheral vascular disease . If a pulse was absent at any one of the six sites palpated , the assessment was considered abnormal . Foot lesions were rated for severity using the Seattle Wound Classification System [ 23 ] , which ranges from a grade of 1.1 ( absence of lesions ) to a grade of 10 ( entire foot or leg is gangrenous ) . In our study , a foot lesion was defined as any wound , with or without functional interruption of the protective cutaneous barrier , ranging from a superficial scratch to an ulcer involving the epidermis . A serious foot lesion was defined by a severity grade of at least 1.3 , which indicates a minor , nonulcerated lesion with clinical evidence of healing sufficient to close previous interruption of the cutaneous barrier [ 23 ] or a blister . Pressure and temperature sensations were measured using the 5.07-log ( 0.1 mg)-force Semmes-Weinstein monofilament and the thermal sensitivity testing apparatus , according to st and ard techniques [ 24 - 26 ] . Thermal sensitivity was considered abnormal if the patient had a value greater than 2 st and ard deviations from the mean value for a group of healthy persons without diabetes ( warm > 2.04 C ; cool > 1.58 C ) . Practice Patterns of Health Care Providers Immediately after each scheduled visit , study patients had a structured interview [ 10 ] with a research assistant , who asked about foot self-examination and foot-care education given by health care providers ( the primary care physician or nursing personnel ) . In addition , a chart audit was conducted by a nurse-clinician who was blinded to the patients ' experimental condition . Information abstract ed from the medical record included the physician 's documentation of the findings from the history and physical examination ; any referral to podiatry , orthopedics , or vascular surgery clinics ; and diagnostic-test ordering related to the evaluation and treatment of diabetes-associated foot problems . Intervention The intervention cohort was exposed to several risk-reduction strategies . The nurse-clinicians conducted the patient education session with one to four patients , covering appropriate foot-care behaviors and footwear , using a commercially available slide and audiotape presentation [ 27 ] and pamphlets [ 28 ] . Behavioral contracts regarding desired foot-care behaviors were negotiated with each patient . Follow-up was done by telephone 2 weeks after the education sessions to remind patients",
"OBJECTIVE To examine whether a telephone-delivered intervention ( TDI ) , design ed to improve glycemie control in patients with non-insulin-dependent diabetes mellitus ( N1DDM ) , improved coronary risk factors in high-risk patients . RESEARCH DESIGN AND METHODS This r and omized controlled trial involved 275 veterans with N1DDM followed in a general medical clinic . Intervention ( TDI ) patients were telephoned at least monthly by a nurse . Calls emphasized compliance with the medical regimen ( diet , medications , and exercise ) , encouraged behavioral changes , and facilitated referrals to a dietitian or smoking cessation clinic . Control patients received no such calls . Baseline and 12-month follow-up measurements included fasting lipid profiles , weight , smoking status ( self-reported ; cessation verified by measurement of exhaled CO ) , adherence to diet and exercise ( self-reported ) , appointments , and medications ( hospital computerized data base ) . RESULTS After 12 months , equal numbers of obese patients in the two groups reported adhering to a diabetic diet and exercising , although more obese TDI patients had seen a dietitian ( 30 vs. 7 % , P = 0.003 ) . Weight loss was not seen in either group ( —0.9 ± 5.3 vs. —0.1 ± 3.6 kg , P = 0.202 ) . Hyperlipidemic TDI patients were more likely to see a dietitian ( 31 vs. 6 % , P = 0.003 ) and receive lipid-lowering medications ( 22 vs. 9 % , P = 0.096 ) , but serum cholesterol reduction was similar between groups ( –11.7 ± 33.4 vs. –4.3 ± 32.7 mg/dl , P = 0.270 ) ; comparable results were seen for high-density lipoprotein , low-density lipoprotein , and triglyceride levels . More TDI group smokers reported quitting ( 26 vs. 0 % , P = 0.033 ) , but the difference was not significant for CO-verified abstention ( 10 vs. 0 % , P = 0.231 ) . CONCLUSIONS The TDI improved self-reported adherence to regimens that might reduce coronary risk , but had little effect on objective measures of risk",
"PURPOSE this study was conducted to determine whether recommendations from the Diabetes Control and Complications Trial ( DCCT ) could be implemented in a large pediatric population using a diabetes clinical nurse specialist program coordinator dedicated to intensive management . METHODS Patients ' charts were review ed to examine HbAic levels from before the results of the DCCT were published and again 1 year after the recommendations were implemented . Patients who met the following criteria ( N=124 ) were enrolled : type 1 diabetes , less than 18 years old , followed at Yale for 1 year prior to the results of the DCCT and 1 year after , and HbA1c level recorded in the medical chart . RESULTS HbA1c levels were significantly lower 1 year after implementing the DCCT protocol ; 3 years later these same patients improved even further as evidence d by another decrease in HbAlC levels . The patients were taking more insulin ( more Ultralente and regular insulin and less NPH ) and had an increased number of injections at both the 1-year and 3-year follow-up points . CONCLUSIONS The DCCT protocol can be implemented in a large population of pediatric patients with the help of a nurse who is dedicated and available to the patients for ongoing adjustments and provides creative ways to overcome the barriers to achieving normoglycemia",
"Effective control of diabetes is known to delay or prevent the end-organ complications of this disease . Can telemedicine improve a patient 's ability to self-manage diabetes ? Twenty-eight patients entered a study comparing home telemedicine consultation with st and ard outpatient care . A nurse case manager contacted the telemedicine group once a week under the direction of a primary care physician , who contacted the telemedicine group once a month . Laboratory studies and total body weight were measured at the beginning and at the end of the 3-month study . The hemoglobin A1c ( HbA1c ) and total body weight improved significantly in the intervention ( telemedicine ) group , as shown by a 16 % reduction in mean HbA1c level ( from 9.5 to 8.2 % ) and a 4 % mean weight reduction ( from 214.3 to 206.7 pounds ) . Based on our experience , we present a functionally based telemedicine classification system to improve the application of electronic medicine in future studies",
"CONTEXT Studies have suggested that the quality of primary care delivered by nurse practitioners is equal to that of physicians . However , these studies did not measure nurse practitioner practice s that had the same degree of independence as the comparison physician practice s , nor did previous studies provide direct comparison of outcomes for patients with nurse practitioner or physician providers . OBJECTIVE To compare outcomes for patients r and omly assigned to nurse practitioners or physicians for primary care follow-up and ongoing care after an emergency department or urgent care visit . DESIGN R and omized trial conducted between August 1995 and October 1997 , with patient interviews at 6 months after initial appointment and health services utilization data recorded at 6 months and 1 year after initial appointment . SETTING Four community-based primary care clinics ( 17 physicians ) and 1 primary care clinic ( 7 nurse practitioners ) at an urban academic medical center . PATIENTS Of 3397 adults originally screened , 1316 patients ( mean age , 45.9 years ; 76.8 % female ; 90.3 % Hispanic ) who had no regular source of care and kept their initial primary care appointment were enrolled and r and omized with either a nurse practitioner ( n = 806 ) or physician ( n = 510 ) . MAIN OUTCOME MEASURES Patient satisfaction after initial appointment ( based on 15-item question naire ) ; health status ( Medical Outcomes Study Short-Form 36 ) , satisfaction , and physiologic test results 6 months later ; and service utilization ( obtained from computer records ) for 1 year after initial appointment , compared by type of provider . RESULTS No significant differences were found in patients ' health status ( nurse practitioners vs physicians ) at 6 months ( P = .92 ) . Physiologic test results for patients with diabetes ( P = .82 ) or asthma ( P = .77 ) were not different . For patients with hypertension , the diastolic value was statistically significantly lower for nurse practitioner patients ( 82 vs 85 mm Hg ; P = .04 ) . No significant differences were found in health services utilization after either 6 months or 1 year . There were no differences in satisfaction ratings following the initial appointment ( P = .88 for overall satisfaction ) . Satisfaction ratings at 6 months differed for 1 of 4 dimensions measured ( provider attributes ) , with physicians rated higher ( 4.2 vs 4.1 on a scale where 5 = excellent ; P = .05 ) . CONCLUSIONS In an ambulatory care situation in which patients were r and omly assigned to either nurse practitioners or physicians , and where nurse practitioners had the same authority , responsibilities , productivity and administrative requirements , and patient population as primary care physicians , patients ' outcomes were comparable",
"This study assessed the impact of an inpatient diabetes education program on : 1 ) staff nurses ' and patients ' knowledge about diabetes , 2 ) hospital length of stay , and 3 ) patients ' glycemic control . Over the course of 1 year , a certified diabetes educator up date d nursing staff about diabetes care and education and coordinated a diabetes education program on two experimental medical units . Length of stay of insuliti-requiritig patients with diabetes and their diabetes knowledge and glycemic control were compared with two control medical units that received no structured diabetes education program . Results showed a significant difference in length of stay and patient knowledge between experimental and control units . Three conditions commonly associated with diabetes ( diabetic ketoacidosis , osteomyelitis , foot ulcer ) did not account for this difference in length of stay . There was no significant difference between the groups in glycemic control following discharge . While all groups showed improvement in their glycosylated hemoglobin values , only the change in the values of the total population and the control groups was significant . The findings suggest that a Certified Diabetes Educator can decrease length of stay in the hospital setting",
"The purpose of this study was to determine the feasibility of providing a diabetes patient education and group-support intervention that was directed by a Mexican-American clinical nurse specialist ( CNS ) , dietitian , and community worker ; consistent with national st and ards ; and design ed for the Mexican-American culture . In a rural Texas-Mexico border community , subjects with diabetes were r and omly selected to participate in the intervention , and a family member of each subject participated as a support person . The intervention involved 8 weeks of educational sessions with instruction on nutrition , blobd glucose self-monitoring , exercise , and other diabetes self-management topics , and provided group support . Group discussion was facilitated using a series of Spanish- language videotapes that had been developed and previously tested in the target Mexican-American community . Results suggested statistically significant improvements in diabetes knowledge , fasting blood sugar levels , and glycosylated hemoglobin levels . The study documented the feasibility and potential benefits of the intervention",
"This study aim ed to determine if patients can set their own educational priorities accurately and if the impact of diabetes education on knowledge differed between patients who did and did not set their own priorities . Forty patients referred for individual education were r and omly assigned to one of two groups . Prior to education with a diabetes specialist nurse ( DSN ) patients ranked 10 diabetes care topics in order of perceived importance and relevance to their needs and completed a knowledge question naire . Group 1 set their own priorities and the DSN directed education according to the patients stated priorities . In Group 2 the DSN set the educational priorities without seeing the patients priority list . The priority ranking by the two groups of the 10 topics and their pre-education knowledge score were not significantly different . Post-education knowledge scores improved equally and significantly in both groups ( Group 1 from 23 to 87 % ; Group 2 from 21 to 79 % ) ; P knowledge scores for the top three priorities were significantly higher than for the three lowest ranked topics . Knowledge is neither dependent on , nor a good discriminator of , patient-selected priorities . There may be reasons why it is important for patients to set their own priorities , but education directed solely at those priorities may leave knowledge deficits which could compromise diabetes care",
"OBJECTIVE To determine the effect of a bicultural community health worker ( CHW ) on completion of diabetes education in an inner-city Hispanic patient population and to evaluate the impact of completion of the education program on patient knowledge , self-care behaviors , and glycemic control . RESEARCH DESIGN AND METHODS Patients were r and omized into CHW intervention and non-CHW intervention groups . All patients received individualized , comprehensive diabetes education from a certified diabetes nurse educator after baseline demographic information , diabetes knowledge , diabetes self-care practice s , and glycohemoglobin levels were assessed . Rates of education program completion were determined . Diabetes knowledge , self-care practice s , and glycohemoglobin levels were reassessed at program completion and at a later postprogram follow-up medical appointment and compared to baseline . Logistic regression analysis and the Mantel-Haenszel χ2 statistic were used to determine the effect of the CHW assignment on program completion . Analyses of covariance were performed with end-of-treatment behavior scores , knowledge scores , and glycohemoglobin levels as outcome variables , controlling for baseline values and testing for the effect of CHW assignment . RESULTS Of 64 patients enrolled in the study , 40 ( 63 % ) completed and 24 ( 37 % ) dropped out before completing the diabetes education program . Of the patients having CHW intervention , 80 % completed the education program , compared with 47 % of patients without CHW intervention ( P = 0.01 ) . “ Dropouts ” were younger ( age 47.5 ± 12.5 years [ mean ± SD ] ) compared with patients who completed the program ( 55.9 ± 9.9 years ) ( P = 0.004 ) . Dropout status showed no significant relationship to educational level achieved or literacy level . For the program “ completers , ” knowledge levels and selected self-care practice s significantly improved , and glycohemoglobin levels improved from a baseline level of 11.7 % to 9.9 % at program completion ( P = 0.004 ) and 9.5 % at the postprogram follow-up ( P program completion , controlling for financial status and language spoken , was extremely robust ( P = 0.007 ) . The effect of the CHW on knowledge , self-care behavior , or glycohemoglobin outcome variables was not statistically significant . CONCLUSIONS These findings suggest that intervention with a bicultural CHW improved rates of completion of a diabetes education program in an inner-city Hispanic patient population irrespective of literacy or educational levels attained . Our data further suggests that completion of individualized diabetes educational strategies leads to improved patient knowledge , self-care behaviors , and glycemic control"
] | 41163ce2-06ff-11f0-808a-c43d1ab1c353 |
BACKGROUND Total hip arthroplasty ( THA ) is one of the most common orthopaedic operations performed worldwide . Painful osteoarthritis of the hip is the primary indication for THA . Following THA , people have conventionally been provided with equipment , such as raised toilet seats and chairs , and educated to avoid activities that could cause the hip joint to be in a position of flexion over 90 degrees , or adduction or rotation past the midline . These aspects of occupational therapy have been advocated to reduce the risks of prosthesis dislocation . However , the appropriateness of these recommendations has been question ed . OBJECTIVES To assess the effects of provision of assistive devices , education on hip pre caution s , environmental modifications and training in activities of daily living ( ADL ) and extended ADL ( EADL ) for people undergoing THA . SEARCH METHODS We search ed MEDLINE ( 1946 to April 2016 ) , EMBASE ( 1947 to April 2016 ) , the Cochrane Library including CENTRAL ( Issue 4 of 12 , 2016 ) , Data base of Review s of Effects ( DARE ) , Health Technology Assessment ( HTA ) , Economic Evaluations Data base ( EED ) , CINAHL , PEDro and CIRRIE from inception to April 2016 . In addition we checked Controlled Clinical Trials , Clinical trials.gov , the National Institutes of Health Trial Registry , the World Health Organization International Clinical Trials Registry Platform ( WHO ICTRP ) and the OpenGrey data base from inception to April 2016 . SELECTION CRITERIA We included r and omised controlled trials ( RCTs ) , quasi- RCTs and cluster- RCTs that evaluated the effectiveness of the provision of assistive devices , education on hip pre caution s , environmental modifications , or training in ADL and EADL for people undergoing THA . The main outcomes of interest were pain , function , health-related quality of life ( HRQOL ) , global assessment of treatment success , reoperation rate , hip dislocation and adverse events . DATA COLLECTION AND ANALYSIS We used st and ard method ological procedures recognised by Cochrane . We conducted a systematic literature search using several data bases and contacted corresponding authors , appraised the evidence using the Cochrane risk of bias tool , analysed the data using a narrative analysis approach ( as it was not possible to conduct a meta- analysis due to heterogeneity in interventions ) , and interpreted all outcomes using the GRADE approach . MAIN RESULTS We included three trials with a total of 492 participants who had received 530 THA . The evidence presented with a high risk of performance , detection and reporting bias . One study ( 81 participants ) compared outcomes for participants r and omised to the provision of hip pre caution s , equipment and functional restrictions versus no provision of hip pre caution s , equipment or functional restrictions . Due to the quality of evidence being very low , we are uncertain if the provision of hip pre caution s , equipment and functional restrictions improved function measured using the Harris Hip Score at 12 month follow-up , or health-related quality of life ( HRQOL ) measured by the Short Form-12 at four week follow-up , compared to not providing this . There were no incidences of hip dislocation or adverse events in either group during the initial 12 postoperative months . The study did not measure pain score , global assessment of treatment success or total adverse events . One study ( 265 participants ; 303 THAs ) evaluated the provision of hip pre caution s with versus without the prescription of postoperative equipment and restrictions to functional activities . Due to the quality of evidence being very low , we are uncertain if perceived satisfaction in the rate of recovery differed in people who were not prescribed postoperative equipment and restrictions ( 135/151 satisfied ) compared to those prescribed equipment and restrictions ( 113/152 ) ( risk ratio ( RR ) 0.83 , 95 % confidence interval ( CI ) 0.75 to 0.93 ; 265 participants , one trial ; number needed to treat for an additional beneficial outcome ( NNTB ) = 7 ) . Due to the low quality evidence , we are uncertain if the incidence of hip dislocation differed between participants provided with hip pre caution s with ( 1/152 ) compared to without providing equipment or restrictions post-THA ( 0/151 ) ( RR 2.98 , 95 % CI 0.12 to 72.59 ) . The study did not measure pain , function , HRQOL , re-operation rates or total adverse events . One study ( 146 participants ) investigated the provision of an enhanced postoperative education and rehabilitation service on hospital discharge to promote functional ADL versus a conventional rehabilitation intervention in the community . This study was of very low quality evidence . We were uncertain if the provision of enhanced postoperative education and rehabilitation improved function at six months follow-up , when assessed using the Objective and Subjective Functional Capability Index ( 146 participants , one trial ; P > 0.05 ; no numerical results provided ) compared to conventional rehabilitation . The study did not measure pain score , HRQOL , global assessment of treatment success , hip dislocation , re-operation rate or total adverse events . AUTHORS ' CONCLUSIONS Very low quality evidence is available from single trials , thus we are uncertain if hip pre caution s with or without the addition of equipment and functional restrictions are effective in preventing dislocation and improving outcomes after THA . There is also insufficient evidence to support or refute the adoption of a postoperative community rehabilitation programme consisting of functional reintegration and education compared to conventional rehabilitation strategies based on functional outcomes .Further high- quality trials are warranted to assess the outcomes of different occupational therapy interventions both in the short and longer-term for those who undergo THA . An assessment of the impact of such interventions on pain and restriction on personal ADL , EADL and instrumental ADL is needed , and also of functional integration-type interventions rather than just hip pre caution s , equipment and restrictions | [
"This prospect i ve , r and omized study compares functional outcomes between a novel support device ( Secure Tracks ™ ) and a st and ard walker following unilateral total knee replacement . Thirty patients were r and omized for the study ; 15 walker patients ( 70.7±6.4 yrs ) and 15 Secure Track patients ( 68.2±6.7 yrs ) ( p=0.31 ) . Total distance walked during all therapy sessions was nearly two times greater in the Secure Track ( 2,332 ft ) than with the walker ( 1,241 ft)(p=.053 ) . This trend began on the day of surgery ( 275 ft vs. 176 ft , p greater amount of time up and ambulating with the therapists in all sessions ( .006.30 ) . At the first clinical follow-up , patients that had walked in the Secure Track completed the timed up and go test ( TUG ) , a predictor of fall risk , 3 seconds faster than the st and ard rehabilitation group ( 9.6 vs. 12.9 seconds , p demonstrated significantly greater pain relief following the TUG test ( p=.005 ) . This study demonstrates that the choice of support device can increase patient ambulation following surgery , which will in turn improve functional outcomes and pain relief",
"Benefits of a direct anterior approach ( DAA ) versus a posterior-lateral ( PA ) approach to THA were assessed in a single-surgeon , IRB-approved , prospect i ve , r and omized clinical study . Subjects ( 43 DAA and 44 PA ) were evaluated at 6 weeks , and 3 , 6 and 12 months . The primary end point was ability to climb stairs normally and walk unlimited at each time point . Secondary end points included assessment by several outcome instruments . DAA subjects performed better during the immediate post-operative period ; they had lower VAS pain scores on the first post-operative day , more subjects climbing stairs normally and walking unlimited at 6 weeks , and higher HOOS Symptoms scores at 3 months . There were no significant differences between groups at later time points . Findings confirm previous reports of benefits of DAA versus PA in early post-operative phases",
"Purpose : Total hip arthroplasty ( THA ) is a common and effective treatment of hip osteoarthritis . Activity restrictions known as hip pre caution s are widely practice d in rehabilitation post THA , aim ing to foster healing and prevent hip dislocation . The focused clinical question was : Does the application of hip pre caution s in patients post THA versus unrestricted activities significantly decrease the risk of prosthetic dislocation ? Methods : A comprehensive literature search was conducted for r and omized controlled trials or cohort studies with a comparative group and minimum 6 months follow-up , with dislocation as an end point . Retrieved titles were assessed independently by 2 review ers for inclusion and underwent st and ardized data extraction . Results : Title search produced 80 potentially relevant articles . Five articles were retrieved for data extraction of which 2 met a prior eligibility criteria . No eligible studies were found that concerned posterior approaches to hip arthroplasty , so the results of this review concern only anterolateral approaches . Neither included study showed any benefit of hip pre caution s in preventing dislocation . Conclusion : The rate of dislocation after anterolateral THA is low and is not improved by hip pre caution s. Hip pre caution s are associated with a slower return to activities , significant expense , and decreased patient satisfaction . Existing studies risk being compromised by a type II error , but a definitive study may be prohibitively large and expensive",
"Tian W , DeJong G , Munin MC , Smout R : Patterns of rehabilitation after hip arthroplasty and the association with outcomes : An episode of care view . Objectives : To examine the patterns of rehabilitation after elective and nonelective hip arthroplasty and its association with outcomes over an episode of postacute care . Design : Data were obtained from a multisite prospect i ve observational cohort study and its companion follow-up study . Patterns of care were measured by the combination of setting s of care where hip arthroplasty patients received rehabilitation therapy . Main outcome measure was motor portion of the functional independence measure . Results : Approximately 90 % of hip arthroplasty patients received rehabilitation care from more than one setting . Eight patterns of care were identified in the follow-up period . Patterns of subsequent care were driven more by initial setting than by etiology . Nonelective hip arthroplasty patients had lower motor functional independence measure scores and used more rehabilitation services than did elective hip arthroplasty patients . Patterns of care were modest factors ( accounted for only 7 % of variance ) in predicting patient motor functional independence measure over an episode of postacute care . Conclusions : Etiology of hip arthroplasty is associated with amounts of rehabilitation care used and outcomes . After the initial postacute rehabilitation setting , patients continued to receive considerable amounts of therapy in various setting s. It is important to look beyond a single setting of care to an entire episode of care when examining clinical outcomes",
"The aim of this study was to investigate whether pre-operative , sensorimotor training results in improved physical function , quality of life , sensorimotor function and reduced disability in total hip replacement patients . 80 subjects awaiting total hip replacement at a Swiss hospital were recruited for this r and omised controlled trial . The intervention group participated in a pre-operative home exercise sensorimotor training programme ; the control group received no therapy . Primary outcome measure was physical function , secondary outcome measures were quality of life , disability and sensorimotor function . Outcomes were measured using generic and disease-specific question naires as well as objective ly assessed balance ability . Measurements were taken one day before surgery and 10 days , 4 and 12 months after surgery . The intervention showed improved quality of life and sensorimotor function before surgery . These effects were lost following surgery . The intervention group experienced more disability at 4 months than the control group . At one year follow-up group-membership influenced quality of life scores depending on the measurement-time-point . It can be concluded that no useful effect was identified for a pre-operative sensory-motor training-programme . The psychological aspects following total hip replacement need to be considered in order to facilitate coping-strategies , reduce unrealistic expectations and increase satisfaction",
"We have developed a 12-item question naire for patients having a total knee replacement ( TKR ) . We made a prospect i ve study of 117 patients before operation and at follow-up six months later , asking them to complete the new question naire and the form SF36 . Some also filled in the Stanford Health Assessment Question naire ( HAQ ) . An orthopaedic surgeon completed the American Knee Society ( AKS ) clinical score . The single score derived from the new question naire had high internal consistency , and its reproducibility , examined by test-retest reliability , was found to be satisfactory . Its validity was established by obtaining significant correlations in the expected direction with the AKS scores and the relevant parts of the SF36 and HAQ . Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at follow-up . We also compared change in scores with the patients ' retrospective judgement of change in their condition . The effect size for the new question naire compared favourably with those for the relevant parts of the SF36 . The change scores for the new knee question naire were significantly greater ( p new question naire provides a measure of outcome for TKR that is short , practical , reliable , valid and sensitive to clinical ly important changes over time",
"Background Total hip arthroplasty ( THA ) is a very common procedure in orthopedic surgery . In the Netherl and s , 25,642 primary THAs were performed in 2013 . Postoperative hip dislocation is one of the major complications and has been reported in 0.5 to 10.6 % of patients after primary THA.Several reports regarding the use of an anterolateral surgical approach have shown that a non-restriction or reduced restriction protocol does not increase the dislocation rate . For the posterolateral surgical approach it has been suggested that patient restrictions might be unnecessary but the amount of available literature is scarce . As such , r and omized controlled trials aim ed at investigating restrictions following THA using a posterior approach are strongly recommended . The aim of this prospect i ve r and omized controlled trial is to investigate the non-inferiority hypothesis concerning the early dislocation rate after THA in patients with and without the use of a reduced restriction protocol . Methods / Design After providing informed consent a group of 456 patients with symptomatic coxarthrosis will be r and omized to receive a THA either with care as usual , i.e. receiving postoperative restrictions including the advice to sleep in a supine position for the first 8 weeks postoperatively , or reduced restrictions with no recommendations regarding the position during sleeping . Primary outcome measure will be the percentage of early dislocations within the first 8 weeks after THA . Secondary outcome measures will be patient satisfaction , time to functional recovery , quality of sleep and patient ’s self-reported compliance with postoperative instructions . Discussion To our knowledge this will be the first r and omized controlled trial that compares a reduced restriction protocol with a restricted protocol following THA using a posterolateral surgical approach . Our hypothesis is that a reduced restriction protocol following THA with use of a posterolateral surgical approach has no influence on the early dislocation rate compared to a restricted protocol . Instead , embracing a reduced restriction protocol might even contribute to a higher quality of sleep , thereby facilitating a faster uptake and return to daily functions in patients after THA.Trial registration Clinical Trials.gov NCT02107248 , registration date 3 April 2014",
"The goal of the current study was to investigate whether preoperative rehabilitation advice reinforced by a patient information booklet can aid recovery after total hip arthroplasty in terms of pain , function , satisfaction , and quality of life . Thirty-five patients awaiting primary total hip arthroplasty were recruited into this study and r and omly allocated before admission to receive either the st and ard pathway of care or the rehabilitation program and booklet . All patients showed increases in function and psychological variables with time . The preoperative class and booklet , however , seemed to have the greatest impact on length of hospital stay , reducing the hospital stay by 3 days , and therapy input required , significantly influencing the cost of the procedure ( the rehabilitation class led to a cost saving of 587 British pounds ; approximately 810 dollars , per patient ) . In addition , patients attending the class reported higher levels of satisfaction ( 99 % satisfied in the preoperative rehabilitation class compared with 80 % in the control group 3 months postoperatively ) and had more realistic expectations of surgery",
"OBJECTIVE To characterize rehabilitation services for patients with knee and hip replacement in 3 types of postacute facilities in the U.S. DESIGN Multi-site prospect i ve observational cohort study . SETTING Eight freest and ing skilled nursing facilities ( SNFs ) , 1 hospital-based SNF , and 11 inpatient rehabilitation facilities ( IRFs ) . PARTICIPANTS Patients ( N=2158 ) with knee or hip replacement . INTERVENTIONS No new interventions . MAIN OUTCOME MEASURES Length of stay ( LOS ) , amount and intensity of physical therapy ( PT ) and occupational therapy ( OT ) , types of therapy activities . RESULTS Average LOS was about 15 days for freest and ing SNF patients , and 9 to 10 days for hospital-based SNF and IRF patients . Freest and ing SNFs and IRFs provide about the same number of hours of PT and OT ; the hospital-based SNF provided 27 % fewer hours . Freest and ing SNFs and the hospital-based SNF provided fewer hours a day than did IRFs . Joint replacement patients across all 3 types of facilities spent , on average , 70 % to 75 % of their PT time in just 2 activities -- exercise and gait and spent 56 % to 66 % of their OT time in 3 activities -- exercise , functional mobility , and dressing lower body . CONCLUSIONS Both freest and ing SNFs and IRFs provided similar amounts of PT with a similar emphasis on exercise and gait activities . IRFs , however , provided more OT than freest and ing SNFs . IRFs had shorter LOSs and more intensive therapy services than freest and ing SNFs . Study freest and ing SNFs exhibited greater variation in LOS and intensity of therapy than IRFs",
"Objective : To assess the feasibility of a pre-operative occupational therapy intervention for patients undergoing primary total hip replacement . Design : Single blinded feasibility r and omised controlled trial , with data collection prior to the intervention , and at 4 , 12 , and 26 weeks following surgery . Setting : Recruitment from two NHS orthopaedic outpatient centres in the West Midl and s , UK . Subjects : Patients awaiting primary total hip replacement due to osteoarthritis were recruited . Following pre-operative assessment , patients were individually r and omised to intervention or control by a computer-generated block r and omisation algorithm stratified by age and centre . Interventions : The intervention group received a pre-surgery home visit by an occupational therapist who discussed expectations , assessed home safety , and provided appropriate adaptive equipment . The control group received treatment as usual . Outcomes : The study assessed the feasibility of recruitment procedures , delivery of the intervention , appropriateness of outcome measures and data collection methods . Health related quality of life and re source use were recorded at 4 , 12 and 26 weeks . Results : Forty-four participants were recruited , 21 were r and omised to the occupational therapy intervention and 23 to usual care . Analysis of 26 week data included 18 participants in the intervention group and 21 in the control . The intervention was delivered successfully with no withdrawals or crossovers ; 5/44 were lost to follow-up with further missing data for participation and re source use . Conclusions : The feasibility study provided the information required to conduct a definitive trial . Burden of assessment would need to be addressed . A total of 219 patients would be required in an efficacy trial",
"Within the context of a double blind r and omized controlled parallel trial of 2 nonsteroidal antiinflammatory drugs , we vali date d WOMAC , a new multidimensional , self-administered health status instrument for patients with osteoarthritis of the hip or knee . The pain , stiffness and physical function subscales fulfil conventional criteria for face , content and construct validity , reliability , responsiveness and relative efficiency . WOMAC is a disease-specific purpose built high performance instrument for evaluative research in osteoarthritis clinical trials",
"Total hip replacement ( THR ) is a common and costly procedure . The number of THR is expected to increase over the coming years . Two pathways of postoperative treatment were compared in a r and omized study . Fifty patients from two hospitals were r and omized into a study group ( SG ) of 27 patients receiving preoperative and postoperative education programs , as well as home visits from an outpatient team . A control group ( CG ) of 23 patients received “ conventional ” rehabilitation augmented by a stay at a rehabilitation center if needed . All costs for the two groups both in hospitals and after discharge were collected and analyzed . On average total costs for the SG were $ 8,550 and $ 11,952 for the CG , a 28 % cost reduction . Total inpatient costs were $ 5,225 for the SG and $ 6,515 for the CG . In a regression analysis the group difference is statistically significant . Adjusting for changes in the Oxford Hip Score gives effective costs ( C/E ) . The ratio of the SGs C/E to the CGs is 0.60 . That is a cost-effectiveness gain of 40 % . A shorter hospital stay augmented with better preoperative education and home treatment appears to be more effective and costs less than the traditional in hospital pathway of treatment",
"UNLABELLED To assess the effectiveness of an environmental falls prevention intervention delivered by qualified occupational therapists or unqualified trained assessors . DESIGN A pilot three-armed r and omized controlled trial . SETTING Airedale National Health Service Trust catchment , North and West Yorkshire , Engl and . PARTICIPANTS Two hundred thirty-eight community-dwelling adults aged 70 and older with a history of falls in the previous year . INTERVENTION Assessment and modification of the home environment of people at greater risk of falls . MEASUREMENTS Fear of falling was the primary outcome measure , and an analysis of covariance was conducted on the area under the curve at 12 months . As a secondary outcome , falls were analysed using negative binomial regression . Quality of life and independence in activities of daily living ( ADLs ) were also measured . RESULTS The intervention had no effect on fear of falling ( P=.63 ) . The occupational therapy group had significantly fewer falls than controls 12 months after the assessment ( incidence rate ratio (IRR)=0.54 , 95 % confidence interval (CI)=0.36 - 0.83 , P=.005 ) . There was no significant effect on falls in the trained assessor group ( IRR=0.78 , 95 % CI=0.51 - 1.21 , P=.34 ) . CONCLUSION Environmental assessment had no effect on fear of falling . Environmental assessment prescribed by an occupational therapist significantly reduced the number of falls in high-risk individuals whereas that prescribed by a trained assessor did not . Further research in other setting s is needed to confirm this , to explore the mechanisms , and to estimate cost-effectiveness",
"This paper reports the results of a study evaluating the effects of an experimental program on post-hospital adjustment of early discharged patients after total hip arthroplasties . This experimental program consisted of patient teaching by means of a pamphlet and videotape , and regular home visits by a community health nurse . A significant difference was found between the experimental and control patients in perceived preparedness for discharge and post-hospital exercise compliance . The early discharged experimental patients demonstrated post-hospital objective and subjective functional capabilities equal to those of the control patients . This study is seen to have implication s for nursing service and nursing education",
"BACKGROUND It is currently unknown whether functional restrictions following total hip arthroplasty can reduce the prevalence of early postoperative dislocation . Our hypothesis was that dislocation was more likely to occur in patients who were not placed on these restrictions . METHODS We performed a prospect i ve , r and omized study to evaluate the role of postoperative functional restrictions on the prevalence of dislocation following uncemented total hip arthroplasty through an anterolateral approach . Of the 630 eligible consecutive patients , 265 patients ( 303 hips ) consented to be r and omized into one of two groups ( the \" restricted \" group or the \" unrestricted \" group ) . The patients in both groups were asked to limit the range of motion of the hip to for the first six weeks after the procedure . The patients in the restricted group were instructed to comply with additional hip pre caution s during the first six weeks postoperatively . Specifically , these patients were managed with the placement of an abduction pillow in the operating room before bed transfer and used pillows to maintain abduction while in bed ; used elevated toilet seats and elevated chairs in the hospital , in the rehabilitation facility , and at home ; and were prevented from sleeping on the side , from driving , and from being a passenger in an automobile . All patients were followed for a minimum of six months postoperatively . RESULTS There was one dislocation in the entire cohort ( prevalence , 0.33 % ) . This dislocation occurred in a patient in the restricted group during transfer from the operating table to a bed with an abduction pillow in place . Patients in the unrestricted group were found to return to side-sleeping sooner ( p ride in automobiles more often ( p drive automobiles more often ( p return to work sooner ( p higher level of satisfaction with the pace of their recovery ( p additional expenditure of approximately $ 655 per patient in the restricted group . CONCLUSIONS Total hip arthroplasty through an anterolateral approach is likely to be associated with a low dislocation rate . Removal of several restrictions did not increase the prevalence of dislocation following primary hip arthroplasty at our institution . However , it did promote substantially lower costs and was associated with a higher level of patient satisfaction as patients achieved a faster return to daily functions in the early postoperative period",
"BACKGROUND Improvements in surgical techniques and increase of femoral head size might have changed the rationale for movement restrictions after total hip replacement ( THR ) . AIM To evaluate the influence of movement restrictions and assistive devices on rehabilitation after fast track THR . DESIGN Non-r and omized , controlled study . SETTING Inpatient . POPULATION 365 consecutively included THR patients . METHODS Patients included the 3 initial month of the study underwent rehabilitation with restrictions in hip movement and a st and ard package of assistive devices ( restricted group ) . This group was compared to patients included the following 3 months with less restricted hip movement and use of assistive devices according to individual needs ( unrestricted group ) . Question naires on function , pain , quality of life ( HOOS ) , anxiety ( HADS ) , working status and patient satisfaction were completed before THR , 3 and 6 weeks after . RESULTS The HOOS function score at the 3 measurement times was ( mean ± SD ) ; unrestricted group : 46 ± 17 - 76 ± 9 - 83 ± 14 compared to restricted group : 43 ± 16 - 81 ± 14 - 83 ± 13 . Changes over time was significantly higher in the restricted group ( P=0.004 ) . Return to work 6 weeks after THR for the unrestricted group compared to restricted group was : 53 % versus 32 % ( P=0.045 ) . No significant differences between groups in pain , symptoms , quality of life , anxiety/depression , hip dislocations and patient satisfaction . CONCLUSION This study showed slightly slower recovery in patient-reported function after reduction in movement restrictions and use of assistive devices , but the difference was eliminated after 6 weeks . Reduced movement restrictions did not affect the other patient-reported outcomes and led to earlier return to work . CLINICAL REHABILITATION IMPACT It is possible to reduce movement restrictions and use of assistive devices considerably . More research on safety issues is needed to eluci date the effect of unrestricted rehabilitation on hip dislocation",
"OBJECTIVE To explore clinical effects of comprehensive rehabilitation therapy for function restore of hip joint after minimally invasive total hip arthroplasty . METHODS From March 2006 to February 2008 , 100 patients were r and omly divided into the treatment group and the control group . Fifty patients in the treatment group , including 21 males and 29 females , ranging in age from 56 to 78 years , with an average of ( 67.2 + /- 11.0 ) years . Fifty patients in the control group , including 26 males and 24 females , ranging in age from 54 to 79 years , with an average of ( 65.5 + /- 11.5 ) years . The course of disease of the two groups were 10 to 15 years . The comprehensive rehabilitations such as joint range of motion , the activities of daily living and restoring muscle strength were performed step-by-step in the treatment group under the guidance of the therapist at the 2nd day after hip arthroplasty . Above rehabilitations were not performed in the control group . The postoperative functional recovery of hip joint , the Harris scores and X-ray were analyzed and compared between the two groups . RESULTS All the patients were followed and the duration averaged 13 months ( 12 to 14 months ) . The therapeutic effects of the two groups had statistical differences , Zc = 12.72 , P Harris score was ( 94.50 + /- 29.87 ) , 32 patients got an excellent result , 12 good , 4 poor and 2 bad . While in the control group , above data were ( 63.50 + /- 19.97 ) , 12 , 15 , 7 and 16 respectively . The therapeutic effects of treatment group were better than those of control group . The X-ray showed that there were no hip prosthesis loosening , femoral neck fractures and other complications . CONCLUSION The early comprehensive rehabilitation after minimally invasive total hip replacement is the key to decrease postoperative complications and to decide the success or failure of surgery",
"We developed a 12-item question naire for completion by patients having total hip replacement ( THR ) . A prospect i ve study of 220 patients was undertaken before operation and at follow-up six months later . Each completed the new question naire as well as the SF36 , and some the Arthritis Impact Measurement Scales ( AIMS ) . An orthopaedic surgeon assessed the Charnley hip score . The single score derived from the question naire had a high internal consistency . Reproducibility was examined by test-retest reliability and was found to be satisfactory . The validity of the question naire was established by obtaining significant correlation in the expected direction with the Charnley scores and relevant scales of the SF36 and the AIMS . Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at the follow-up . The st and ardised effect size for the new question naire compared favourably with that for the SF36 and the AIMS . The new question naire provides a measure of outcome for THR which is short , practical , reliable , valid and sensitive to clinical ly important changes",
"Currently , many rehabilitation protocol s for total hip replacements ( THRs ) include activity restrictions to prevent postoperative dislocation . There is increasing dem and for more efficient and safe rehabilitation protocol s. This r and omized prospect i ve study evaluates the need for hip restrictions following a modified anterolateral procedure . From 2004 to 2008 , 81 patients seeking elective THRs were r and omly assigned into a st and ard rehabilitation group or an early rehabilitation group . The st and ard group included restrictions to avoid hip flexion > 90 degrees and avoidance of riding in a car for the first postoperative month . The early group had no flexion or car riding restrictions . Forty-three patients were in the st and ard group and 38 patients were in the early group . There were no significant demographic differences between the 2 groups . All patients completed the Short Form 12- question Health Survey and Harris Hip Score preoperatively and at 4 weeks , 1 month , 3 months , and 1 year postoperatively . The time-points at which the patient first drove and ambulated with a cane , without a cane , and without a limp were also collected . No incidents of dislocation occurred . Patients in the early group were faster to ambulate with only a cane ( P=.03 ) , without a cane ( P without a limp ( P=.003 ) . They also drove earlier ( P=.02 ) . Pace of recovery was the only significant difference between the 2 groups . The early rehabilitation protocol increases the pace of recovery compared to a pathway with hip pre caution s without increasing complications"
] | 41163d28-06ff-11f0-808a-c43d1ab1c353 |
PURPOSE To up date American Society of Clinical Oncology/American Society of Hematology recommendations for use of erythropoiesis-stimulating agents ( ESAs ) in patients with cancer . METHODS An Up date Committee review ed data published between January 2007 and January 2010 . MEDLINE and the Cochrane Library were search ed . RESULTS The literature search yielded one new individual patient data analysis and four literature -based meta-analyses , two systematic review s , and 13 publications reporting new results from r and omized controlled trials not included in prior or new review s. RECOMMENDATIONS For patients undergoing myelosuppressive chemotherapy who have a hemoglobin ( Hb ) level less than 10 g/dL , the Up date Committee recommends that clinicians discuss potential harms ( eg , thromboembolism , shorter survival ) and benefits ( eg , decreased transfusions ) of ESAs and compare these with potential harms ( eg , serious infections , immune-mediated adverse reactions ) and benefits ( eg , rapid Hb improvement ) of RBC transfusions . Individual preferences for assumed risk should contribute to shared decisions on managing chemotherapy-induced anemia . The Committee caution s against ESA use under other circumstances . If used , ESAs should be administered at the lowest dose possible and should increase Hb to the lowest concentration possible to avoid transfusions . Available evidence does not identify Hb levels ≥ 10 g/dL either as thresholds for initiating treatment or as targets for ESA therapy . Starting doses and dose modifications after response or nonresponse should follow US Food and Drug Administration-approved labeling . ESAs should be discontinued after 6 to 8 weeks in nonresponders . ESAs should be avoided in patients with cancer not receiving concurrent chemotherapy , except for those with lower risk myelodysplastic syndromes . Caution should be exercised when using ESAs with chemotherapeutic agents in diseases associated with increased risk of thromboembolic complications . Table 1 lists detailed recommendations | [
"Chronic anemia of cancer can be corrected in approximately 50 % of the cases by treatment with recombinant human erythropoietin ( rHuEPO ) . Early prediction of responsiveness would avoid the emotional and financial burden of ineffective medical intervention . Eighty patients with chronic anemia of cancer undergoing treatment with rHuEPO ( 150 U/kg , 3 times per week by subcutaneous injection ; after 6 weeks without response , 300 U/kg ) participated in this study . Response was defined as a gain of at least 2 g/dL hemoglobin ( Hb ) within 12 weeks . Multivariate discriminant analysis and logistic regression analysis of response were performed on routine blood tests ; serum levels of EPO , iron , ferritin , transferrin , and its receptor ; World Health Organization ( WHO ) performance status ; various cytokines ; neopterin ; stem cell factor ; C-reactive protein ; and alpha 1-antitrypsin . At baseline , none of these factors showed sufficient prognostic power . The following predictive algorithm was developed : ( 1 ) If after 2 weeks of therapy both the serum EPO level is > or = 100 mU/mL and Hb concentration has not increased by at least 0.5 g/dL , unresponsiveness of the patient is very likely ( predictive power , 93 % ) ; otherwise , response may be predicted with an accuracy of 80 % . ( 2 ) If both the serum level of EPO is less than 100 mU/mL and Hb concentration has increased by > or = 0.5 g/dL , response is highly probable ( predictive power , 95 % ) . ( 3 ) Alternatively , a serum ferritin level of > or = 400 ng/mL after 2 weeks of rHuEPO therapy strongly indicates unresponsiveness ( predictive power , 88 % ) , whereas a level less than 400 ng/mL suggests response in 3 of 4 patients",
"Inflammatory cytokines are important predictors of cardiovascular mortality especially in patients with chronic kidney disease . Here we explored the relationship of anemia and epoetin treatment to inflammatory cytokine levels in patients with chronic kidney disease . One hundred non-dialysis patients with chronic kidney disease over 18 years of age were evenly split into anemic and non-anemic cohorts . Of the 50 anemic patients , 23 were receiving erythropoiesis stimulating agents treatments . Levels of tumor necrosis factor (TNF)-alpha were found to be significantly higher and serum albumin was significantly lower with trends towards higher interleukin (IL)-6 and IL-8 in anemic compared to non-anemic patients . Further analysis by multiple logistic regression found that anemic patients treated with erythropoiesis stimulating agents had significantly higher odds for the upper two quartiles for IL-6 , IL-8 and TNF-alpha compared to non-anemic patients . Our study found that the anemia of chronic kidney disease was associated with up regulation of TNF-alpha , and possibly IL-6 and IL-8 along with increased levels of these proinflammatory cytokines in patients treated with epoetin",
"Previous phase I-II clinical trials have shown that recombinant human erythropoietin ( rHuEpo ) can ameliorate anemia in a portion of patients with multiple myeloma ( MM ) and non-Hodgkin 's lymphoma ( NHL ) . Therefore , we performed a r and omized controlled multicenter study to define the optimal initial dosage and to identify predictors of response to rHuEpo . A total of 146 patients who had hemoglobin ( Hb ) levels entered this trial . Patients were r and omized to receive 1,000 U ( n = 31 ) , 2,000 U ( n = 29 ) , 5,000 U ( n = 31 ) , or 10,000 U ( n = 26 ) of rHuEpo daily subcutaneously for 8 weeks or to receive no therapy ( n = 29 ) . Of the patients , 84 suffered from MM and 62 from low- to intermediate- grade NHL , including chronic lymphocytic leukemia ; 116 of 146 ( 79 % ) received chemotherapy during the study . The mean baseline Hb level was 9.4 + /- 1.0 g/dL. The median serum Epo level was 32 mU/mL , and endogenous Epo production was found to be defective in 77 % of the patients , as judged by a value for the ratio of observed-to-predicted serum Epo levels ( O/P ratio ) of efficacy . The median average increase in Hb levels per week was 0.04 g/dL in the control group and -0.04 ( P = .57 ) , 0.22 ( P = .05 ) , 0.43 ( P = .01 ) , and 0.58 ( P = .0001 ) g/dL in the 1,000 U , 2,000 U , 5,000 U , and 10,000 U groups , respectively ( P values versus control ) . The probability of response ( delta Hb > or = 2 g/dL ) increased steadily and , after 8 weeks , reached 31 % ( 2,000 U ) , 61 % ( 5,000 U ) , and 62 % ( 10,000 U ) , respectively . Regression analysis using Cox 's proportional hazard model and classification and regression tree analysis showed that serum Epo levels and the O/P ratio were the most important factors predicting response in patients receiving 5,000 or 10,000 U. Approximately three quarters of patients presenting with Epo levels inappropriately low for the degree of anemia responded to rHuEpo , whereas only one quarter of those with adequate Epo levels did so . Classification and regression tree analysis also showed that doses of 2,000 U daily were effective in patients with an average platelet count greater than 150 x 10(9)/L. About 50 % of these patients are expected to respond to rHuEpo . Thus , rHuEpo was safe and effective in ameliorating the anemia of MM and NHL patients who showed defective endogenous Epo production . From a practical point of view , we conclude that the decision to use rHuEpo in an individual anemic patient with MM or NHL should be based on serum Epo levels , whereas the choice of the initial dosage should be based on residual marrow function",
"This phase 3 prospect i ve r and omized trial evaluated the efficacy and long-term safety of erythropoietin ( EPO ) with or without granulocyte colony-stimulating factor plus supportive care ( SC ; n = 53 ) versus SC alone ( n = 57 ) for the treatment of anemic patients with lower-risk myelodysplastic syndromes . The response rates in the EPO versus SC alone arms were 36 % versus 9.6 % , respectively , at the initial treatment step , 47 % in the EPO arm , including subsequent steps . Responding patients had significantly lower serum EPO levels ( 45 % vs 5 % responses for levels or = 200 mU/mL ) and improvement in multiple quality -of-life domains . With prolonged follow-up ( median , 5.8 years ) , no differences were found in overall survival of patients in the EPO versus SC arms ( median , 3.1 vs 2.6 years ) or in the incidence of transformation to acute myeloid leukemia ( 7.5 % and 10.5 % patients , respectively ) . Increased survival was demonstrated for erythroid responders versus nonresponders ( median , 5.5 vs 2.3 years ) . Flow cytometric analysis showed that the percentage of P-glycoprotein(+ ) CD34(+ ) marrow blasts was positively correlated with longer overall survival . In comparison with SC alone , patients receiving EPO with or without granulocyte colony-stimulating factor plus SC had improved erythroid responses , similar survival , and incidence of acute myeloid leukemia transformation",
"Health-related quality of life ( HrQOL ) assessment s are gaining importance as outcome measures in cancer clinical trials . A recently published clinical trial reported statistically significant ( P HrQOL scores following the administration of recombinant human erythropoietin ( r-HuEPO , epoetin alfa ) versus placebo to anaemic cancer patients who received non-platinum chemotherapy . This study employed five cancer-specific HrQOL instruments . Hb and HrQOL data from this trial were analysed to estimate the minimally important difference ( MID ) in HrQOL measures that could be interpreted as clinical ly meaningful , with Hb level selected as the best external st and ard . Patients were assigned to two groups : improved ( Hb increases of > /=1 g/dL ) or stable ( change in Hb of-1 g/dL to HrQOL in the improved group versus the stable group . By this analysis , the differences in HrQOL scores between the epoetin alfa group and the placebo group were clinical ly important for all Hb-sensitive , cancer-specific HrQOL evaluations . Linear regression analyses performed to provide estimates of the MID for specific values of Hb change confirmed that the differences in HrQOL scores between patient groups were clinical ly significant . These analyses were repeated using a data set from a separate clinical trial , which further supported the conclusion that observed HrQOL changes demonstrated in the multicentre , double-blind study were clinical ly important . These methods provide one means for interpreting the clinical relevance of changes in HrQOL evaluated in clinical trials",
"PURPOSE To exp and on our experience with the combination of paclitaxel , fluorouracil , hydroxyurea , and twice daily irradiation ( T-FHX ) and to assess the impact of weekly administration of erythropoietin ( r-HuEpo ) on transfusion requirements , we conducted a Phase II multi-institutional trial with a simplified 1-h paclitaxel infusion schedule and r and omized patients to receive weekly doses of r-HuEpo . PATIENTS AND METHODS A total of 90 patients with locally advanced head and neck cancers ( stage IV , 96 % ; N(2)/N(3 ) , 66 % ) were treated on a regimen of 1-h infusion of paclitaxel ( 100 mg/m(2)/day , day 1 ) , 120-h infusion of 5-fluorouracil ( 600 mg/m(2)/day , days 0 - 5 ) ; hydroxyurea 500 mg p.o . every 12 h for 11 doses ; and radiation 150cGy bid , days 1 - 5 of each 14-day cycle repeated for five cycles over 10 weeks ( 7200 - 7500 cGy ) . Before initiating therapy , patients were r and omized to receive r-HuEpo 40,000 IU s.c . once weekly . RESULTS At median follow-up of 40 months , 3-year progression-free survival is 62 % , locoregional control is 84 % , and systemic control is 79 % . Overall survival is 59 % . Anemia , leucopenia , dermatitis , and mucositis were the most frequent grade 3 or 4 toxicities . Patients r and omized to erythropoietin experienced less grade 2/3 anemia ( 52 versus 77 % ; P = 0.02 ) , but transfusion requirements were not significantly different . CONCLUSIONS T-FHX is an active and tolerable regimen inducing local tumor control and promising survival with organ preservation in high-risk patients . One h infusion of paclitaxel simplified the regimen without compromising efficacy . Addition of erythropoietin does not reduce the need for transfusion with this nonplatinum-containing regimen . T-FHX should be advanced to a r and omized trial and compared with a cisplatin-based concomitant regimen",
"Despite the prevalence of anemia in cancer , recombinant erythropoietin ( Epo ) has declined in use because of recent Phase III trials showing more rapid cancer progression and reduced survival in subjects r and omized to Epo . Since Epo receptor ( EpoR ) , Jak2 , and Hsp70 are well-characterized mediators of Epo signaling in erythroid cells , we hypothesized that Epo might be especially harmful in patients whose tumors express high levels of these effectors . Because of the insensitivity of immunohistochemistry for detecting low level EpoR protein , we developed assays to measure levels of EpoR , Jak2 and Hsp70 mRNA in formalin-fixed paraffin-embedded ( FFPE ) tumors . We tested 23 archival breast tumors as well as 136 archival head and neck cancers from ENHANCE , a Phase III trial of 351 patients r and omized to Epo versus placebo concomitant with radiotherapy following complete resection , partial resection , or no resection of tumor . EpoR , Jak2 , and Hsp70 mRNA levels varied > 30-fold , > 12-fold , and > 13-fold across the breast cancers , and > 30-fold , > 40-fold , and > 30-fold across the head and neck cancers , respectively . Locoregional progression-free survival ( LPFS ) did not differ among patients whose head and neck cancers expressed above- versus below-median levels of EpoR , Jak2 or Hsp70 , except in the subgroup of patients with unresected tumors ( n = 28 ) , where above-median EpoR , above-median Jak2 , and below-median Hsp70 mRNA levels were all associated with significantly poorer LPFS . Our results provide a framework for exploring the relationship between Epo , cancer progression , and survival using archival tumors from other Phase III clinical trials",
"Background Several studies have shown that darbepoetin alfa , an erythropoiesis-stimulating agent ( ESA ) , can reduce transfusions and increase hemoglobin ( Hb ) levels in patients with chemotherapy-induced anemia ( CIA ) . Recent safety concerns , however , have prompted changes to ESA product information . In the European Union and United States , ESA therapy initiation for CIA is now recommended at a Hb level ≤10 g/dL. The present exploratory analysis examined how ESA initiation at this Hb level may impact patient care . Methods Data from a phase 3 r and omized trial were retrospectively reanalyzed . CIA patients with nonmyeloid malignancies were r and omized 1:1 to 500 mcg darbepoetin alfa every three weeks ( Q3W ) or 2.25 mcg/kg darbepoetin alfa weekly ( QW ) for 15 weeks . A previously published report from this trial showed Q3W dosing was non-inferior to QW dosing for reducing transfusions from week 5 to end-of-the-treatment period ( EOTP ) . In the present analysis , outcomes were reanalyzed by baseline Hb included transfusion rates , Hb outcomes , and safety profiles . Results This study reanalyzed 351 and 354 patients who initiated ESA therapy at a baseline Hb of 10 g/dL or ≥10 g/dL , respectively . From week 5 to EOTP , the estimated Kaplan-Meier transfusion incidence ( Q3W vs QW ) was lower in the ≥10 g/dL baseline-Hb group ( 14 % vs 21 % ) compared with the a mean Hb ≥11 g/dL. The Kaplan-Meier estimate of percentage of patients ( Q3W vs QW ) who achieved Hb ≥11 g/dL from week 1 to EOTP was 90 % vs 85 % in the ≥10 g/dL baseline-Hb group and 54 % vs 57 % in the maintained mean Hb levels and had similar safety profiles , though more patients in the ≥10 g/dL baseline-Hb group reached the threshold Hb of ≥13 g/dL. Conclusion In this exploratory analysis , darbepoetin alfa Q3W and QW raised Hb levels and maintained mean Hb at transfusions and faster anemia correction . Additional studies should prospect ively evaluate the relationship between Hb levels at ESA initiation and outcomes .Trial Registration Clinical Trials.gov Identifier NCT00118638",
"Anemia result ing from cancer or its treatment is an important clinical problem increasingly treated with the recombinant hematopoietic growth factor erythropoietin . To address uncertainties regarding indications and efficacy , the American Society of Clinical Oncology and the American Society of Hematology developed an evidence -based clinical practice guideline for the use of epoetin in patients with cancer . The guideline panel found good evidence to recommend use of epoetin as a treatment option for patients with chemotherapy-associated anemia with a hemoglobin ( Hgb ) concentration below 10 g/dL. Use of epoetin for patients with less severe anemia ( Hgb level below 12 g/dL but never below 10 g/dL ) should be determined by clinical circumstances . Good evidence from clinical trials supports the use of subcutaneous epoetin thrice weekly ( 150 U/kg ) for a minimum of 4 weeks . Less strong evidence supports an alternative weekly ( 40 000 U/wk ) dosing regimen , based on common clinical practice . With either administration schedule , dose escalation should be considered for those not responding to the initial dose . In the absence of response , continuing epoetin beyond 6 - 8 weeks does not appear to be beneficial . Epoetin should be titrated once the hemoglobin concentration reaches 12 g/dL. Evidence from one r and omized controlled trial supports use of epoetin for patients with anemia associated with low-risk myelodysplasia not receiving chemotherapy ; however , there are no published high- quality studies to support its use for anemia in other hematologic malignancies in the absence of chemotherapy . Therefore , for anemic patients with hematologic malignancies it is recommended that physicians initiate conventional therapy and observe hematologic response before considering use of epoetin",
"PURPOSE To investigate the effect of recombinant human erythropoietin ( epoetin beta ) on anemia , transfusion need , and quality of life ( QOL ) in severely anemic patients with low- grade non-Hodgkin 's lymphoma ( NHL ) , chronic lymphocytic leukemia ( CLL ) , or multiple myeloma ( MM ) . PATIENTS AND METHODS Transfusion-dependent patients with NHL ( n = 106 ) , CLL ( n = 126 ) , or MM ( n = 117 ) and a low serum erythropoietin concentration were r and omized to receive epoetin beta 150 IU/kg or placebo subcutaneously three times a week for 16 weeks . Primary efficacy criteria were transfusion-free and transfusion- and severe anemia-free survival ( hemoglobin [ Hb ] > 8.5 g/dL ) between weeks 5 to 16 . Response was defined as an increase in Hb > or = 2 g/dL with elimination of transfusion need . QOL was assessed by the Functional Assessment of Cancer Therapy scale . RESULTS Transfusion-free ( P = .0012 ) survival and transfusion- and severe anemia-free survival ( P = .0001 ) were significantly greater in the epoetin beta group versus placebo ( Wald chi(2 ) test ) , giving a relative risk reduction of 43 % and 51 % , respectively . The response rate was 67 % and 27 % in the epoetin beta versus the placebo group , respectively ( P QOL significantly improved in the epoetin beta group compared with placebo ( P Hb concentration ( > or = 2 g/dL ) . A target Hb that could be generally recommended could not be identified . CONCLUSION Many severely anemic and transfusion-dependent patients with advanced MM , NHL , and CLL and a low performance status benefited from epoetin therapy , with elimination of severe anemia and transfusion need , and improvement in QOL",
"BACKGROUND In the United States , darbepoetin alfa ( Aranesp ) is often used to treat patients with chemotherapy-induced anemia using weekly or every-2-week administration schedules . In Europe , darbepoetin alfa is used either weekly or in every-3-week dosing . The every-3-week schedule can be synchronized with many chemotherapy regimens , result ing in fewer visits and reducing burden to patients , but the safety and efficacy of this regimen have not been clear . METHODS A r and omized , double-blind , double-dummy , active-controlled phase 3 trial was performed in 110 European centers . Eligible patients ( age > or = 18 years ) were anemic ( hemoglobin level Patients were r and omly assigned 1:1 to darbepoetin alfa treatment every 3 weeks ( 500-microg dose ) or weekly ( 2.25-microg/kg ) for 15 weeks . We compared red blood cell transfusion incidence among the two arms from week 5 to the end of the treatment phase using a noninferiority study design . Noninferiority was determined if the upper limit of the 95 % confidence interval ( CI ) for the difference in blood transfusions between groups , calculated using Kaplan-Meier methods , did not exceed 12.5 % , a margin based on previous placebo-controlled studies . RESULTS A total of 705 patients were r and omly assigned , and 672 remained in the study at week 5 . Fewer patients in the every-3-week arm than in the weekly arm received blood transfusions from week 5 to the end of the treatment phase ( unadjusted Kaplan-Meier estimates = 23 % versus 30 % , difference = -6.8 % ; 95 % CI = -13.6 to 0.1 ) . Percentages of patients achieving the target hemoglobin level ( > or = 11 g/dL , consistent with evidence -based practice guidelines ) were 84 % ( every 3 weeks ) and 77 % ( weekly ) . The frequency of cardiovascular/thromboembolic adverse events was 8 % in both groups , and safety was comparable . CONCLUSIONS Patients with chemotherapy-induced anemia can safely and effectively be treated with 500 microg of darbepoetin alfa every 3 weeks",
"PURPOSE To determine whether weekly epoetin alfa could improve hemoglobin ( HgB ) levels , reduce RBC transfusions , and improve quality of life ( QOL ) in patients with advanced cancer and with anemia after receiving myelosuppressive chemotherapy . PATIENTS AND METHODS This double-blind , placebo-controlled study r and omly assigned patients to placebo or epoetin alfa ( Ortho Biotech , Bridgewater , NJ ) 40,000 U subcutaneous weekly for 16 weeks . QOL , HgB , and RBC transfusions were measured pretreatment and monthly . RESULTS The study accrued 344 patients ; 330 were assessable for efficacy and 305 were assessable for QOL . Placebo-treated patients had a mean increase in HgB of 0.9 g/dL ( range , -3.8 to + 5.3 ) compared with 2.8 g/dL ( range , -2.2 to + 7.5 ) for epoetin-treated patients ( P placebo-treated patients achieved a > or = 2 g/dL HgB increase compared with 72.7 % of epoetin-treated patients ( P incidence of RBC transfusion for placebo and epoetin treatment arms was 39.6 % and 25.3 % ( P = .005 ) , respectively . The placebo group received 256 units of RBCs compared with 127 units in the epoetin group ( P incidence of toxicity in the groups was similar . Changes in the average QOL scores from baseline to the end of the study were similar in the two groups ( P = not significant ) . The HgB responders ( irrespective of treatment arm ) had a mean change in Functional Assessment of Cancer Therapy ( FACT ) fatigue score from a baseline of + 5.1 compared with -2.1 for the nonresponders ( P = .006 ) . CONCLUSION Epoetin alfa significantly improved HgB and reduced transfusions in this patient population . These results support the use of weekly epoetin alfa as an ameliorative agent for cancer-related anemia",
"PURPOSE The efficacy and safety of darbepoetin alpha ( DA ) for treating patients with active cancer and anemia not receiving or planning to receive cytotoxic chemotherapy or myelosuppressive radiotherapy was evaluated . PATIENTS AND METHODS Patients with active cancer and anemia not receiving or planning to receive chemotherapy or radiotherapy were enrolled onto a phase III , multicenter , r and omized , placebo-controlled study and administered placebo or DA 6.75 microg/kg every 4 weeks ( Q4W ) for up to 16 weeks with a 2-year follow-up for survival . Patients who completed 16 weeks of treatment could receive the same treatment as r and omized Q4W for an additional 16 weeks . The primary end point was all occurrences of transfusions from weeks 5 through 17 ; safety end points included incidence of adverse events and survival . RESULTS The incidence of transfusions between weeks 5 and 17 was lower in the DA group but was not statistically significantly different from that of placebo . DA was associated with an increased incidence of cardiovascular and thromboembolic events and more deaths during the initial 16-week treatment period . Long-term survival data demonstrated statistically significantly poorer survival in patients treated with DA versus placebo ( P = .022 ) . This effect varied by baseline covariates including , sex , tumor type , and geographic region ; statistical significance diminished ( P = .12 ) when the analysis was adjusted for baseline imbalances or known prognostic factors . CONCLUSION DA was not associated with a statistically significant reduction in transfusions . Shorter survival was observed in the DA arm ; thus , this study does not support the use of erythropoiesis-stimulating agents in this subset of patients with anemia of cancer",
"The myelodysplastic syndromes ( MDSs ) are heterogeneous with respect to clinical characteristics , pathologic features , and cytogenetic abnormalities . This heterogeneity is a challenge for evaluating response to treatment . Therapeutic trials in MDS have used various criteria to assess results , making cross- study comparisons problematic . In 2000 , an International Working Group ( IWG ) proposed st and ardized response criteria for evaluating clinical ly significant responses in MDS . These criteria included measures of alteration in the natural history of disease , hematologic improvement , cytogenetic response , and improvement in health-related quality of life . The relevance of the response criteria has now been vali date d prospect ively in MDS clinical trials , and they have gained acceptance in research studies and in clinical practice . Because limitations of the IWG criteria have surfaced , based on practical and reported experience , some modifications were warranted . In this report , we present recommendations for revisions of some of the initial criteria",
"PURPOSE To determine whether maintaining HGB levels > or = 12.0 g/dL with recombinant human erythropoietin ( R-HUEPO ) compared to \" st and ard \" treatment ( transfusion for HGB progression-free survival ( PFS ) , overall survival ( OS ) and local control ( LC ) in women receiving concurrent weekly cisplatin and radiation ( CT/RT ) for carcinoma of the cervix . In addition , to determine whether platinum-DNA adducts were associated with clinical characteristics or outcome . METHODS Patients with stage IIB-IVA cervical cancer and HGB were r and omly assigned to CT/RT+/-R-HUEPO ( 40,000 units s.c . weekly ) . R-HUEPO was stopped if HGB > 14.0 g/dL. Endpoints were PFS , OS and LC . Platinum-DNA adducts were quantified using immunocytochemistry assay in buccal cells . RESULTS Between 08/01 and 09/03 , 109 of 114 patients accrued were eligible . Fifty-two received CT/RT and 57 CT/RT+R-HUEPO . The study closed prematurely , with less than 25 % of the planned accrual , due to potential concerns for thromboembolic event ( TE ) with R-HUEPO . Median follow-up was 37 months ( range 9.8 - 50.4 months ) . PFS and OS at 3 years should be 65 % and 75 % for CT/RT and 58 % and 61 % for CT/RT+R-HUEPO , respectively . TE occurred in 4/52 receiving CT/RT and 11/57 with CT/RT+R-HUEPO , not all considered treatment related . No deaths occurred from TE . High-platinum adducts were associated with inferior PFS and LC . CONCLUSION TE is common in cervical cancer patients receiving CT/RT . Difference in TE rate between the two treatments was not statistically significant . The impact of maintaining HGB level > 12.0 g/dL on PFS , OS and LC remains undetermined",
"OBJECTIVE The efficacy and safety of weekly administration of epoetin beta ( EPO ) for chemotherapy-induced anemia ( CIA ) patients was evaluated . METHODS One hundred and twenty-two patients with lung cancer or malignant lymphoma undergoing chemotherapy were r and omized to the EPO 36 000 IU group or the placebo group . Hematological response and red blood cell ( RBC ) transfusion requirement were assessed . Quality of life ( QOL ) was assessed using the Functional Assessment of Cancer Therapy-Anemia ( FACT-An ) question naire . RESULTS Mean change in hemoglobin level with EPO increased significantly over placebo ( 1.4 + /- 1.9 g/dl versus -0.8 + /- 1.5 g/dl ; P change in hemoglobin level > or = 2.0 g/dl was higher for EPO than those for placebo ( P proportion of RBC transfusion or hemoglobin level EPO than those for placebo ( P = 0.046 ) . The changes in the FACT-An total Fatigue Subscale Score ( FSS ) were less deteriorated with EPO than those with placebo . Progressive disease ( PD ) did not influence the change in hemoglobin level but there was less decrease in FSS in non-PD patients . No significant differences in adverse events were observed . Thrombovascular events and pure red cell aplasia related to EPO were not observed . Retrospective analysis of survival showing the hazard ratio of EPO to placebo was 0.94 . CONCLUSION Weekly administration of EPO 36 000 IU significantly increased hemoglobin level and ameliorated the decline of QOL in CIA patients over the 8-week administration period",
"In myelodysplastic syndromes ( MDS ) , anemia responds to recombinant human erythropoietin ( rHuEPO ) alone and in combination with recombinant human granulocyte-colony-stimulating factor ( rHuGCSF ) in 10 % to 20 % and in 35 % to 40 % of patients , respectively . We r and omly divided 60 patients with low- grade anemic MDS and serum EPO levels lower than 500 IU/L ( 500 mU/mL ) into 2 groups : rHuEPO + rHuG-CSF ( arm A ) and supportive care ( arm B ) . After 12 weeks , those who had erythroid responses were given rHuEPO alone for 40 additional weeks . They were also given rHuG-CSF if they had relapses . A response was considered major if the hemoglobin ( Hb ) level was 115 g/L ( 11.5 g/dL ) or higher and minor Hb increase was 15 g/L ( 1.5 g/dL ) or more or if it remained stable without transfusion . Ten of 24 patients responded in arm A , and 0 of 26 responded in arm B ( P = .01 ) . Eight patients in arm A continued rHuEPO therapy alone , and 6 had relapses . Responses were always restored when rHuG-CSF was reintroduced . Mean direct costs per patient were 26,723 euros ( arm A ) and 8,746 euros ( arm B ) . Quality of life was assessed with a Functional Assessment of Cancer Therapy-Anemia ( FACT-An ) scale . Similar percentages of patients from both arms showed significant clinical improvement . rHuEPO plus rHuG-CSF led to responses in 41.7 % of MDS patients . This treatment was expensive . No effect on quality of life was demonstrated",
"A recent study in dogs suggested that erythropoietin ( EPO ) not only promotes the synthesis of increased numbers of reticulated platelets but that these newly produced platelets are hyperreactive compared with controls . Because of the increasing use of EPO in the perioperative setting , we characterized the effects of EPO on platelet reactivity in healthy human volunteers . In a r and omized , controlled trial , we studied the effects of EPO on platelet reactivity , thrombopoiesis , and endothelial activation in circumstances similar to those of autologous blood donation . Thirty healthy male volunteers received placebo or EPO ( 100 or 500 U/kg of body weight given intravenously ) three times a week for 2 weeks and underwent phlebotomy on days 8 and 15 . Thrombin receptor-activating peptide induced expression of P-selectin , and CD63 increased 2- to 3-fold during EPO treatment . The enhanced platelet reactivity was also reflected by a 50 % increase in soluble P-selectin in plasma . Plasma E-selectin levels increased in a dose-dependent fashion by more than 100 % during EPO treatment , indicating substantial activation of endothelial cells . A 10 % to 20 % increase in platelet counts was observed in both EPO groups on day 5 . In the placebo group , platelets increased only several days after the first phlebotomy . The increase in platelet counts was not reflected by changes in the amounts of reticulated platelets or circulating progenitor cells . In summary , we found that EPO markedly enhances endothelial activation and platelet reactivity , which may adversely affect patients at cardiovascular risk . However , the increased platelet reactivity could be exploited in patients with platelet dysfunction . ( Blood . 2000;95:2983 - 2989",
"Background : Cervical cancer , in women , is the second most common cancer world wide , next to breast cancer . During the treatment of carcinoma cervix , anemia is selectively frequent and its origin is complex combining hemorrhage , iron deprivation , inflammatory reactions and infection . The objective of this study is to evaluate the role of epoetin in correction of anemia and on treatment outcomes in patients with advanced cervical cancer receiving concurrent chemoradiotherapy . Results : A total of 120 patients were enrolled in the study of which 60 patients were r and omized to receive epoetin beta in the treatment arm and 60 patients were in control arm where epoetin beta was not given . Total two and three patients absconded during treatment from treatment and control arm respectively ; therefore total evaluable patients were 115 . Mean Hb at baseline in the control arm was 10.70 + /- 0.62 g/dl and 10.45 + /- 0.43 g/dl in the treatment arm ( p = NS ) . At the end of treatment mean Hb increased by 1.55 g/dl in patients receiving epoetin beta ( p blood transfusion in patients receiving epoetin beta ( p energy level , activity level and overall quality of life in the treatment arm ( p overall survival ( p > 0.05 ) , or disease free survival ( p > 0.05 ) between the two study arms . Adverse events were well matched between the two study arms . No Thromboembolic events associated with epoetin beta was observed in our study . Material and methods : Total 120 , stage IIB to IIIB cervical cancer patients , aged 18 - 70 years with 9.50 - 12.50 g/dl baseline Hb value who were to receive radiotherapy together with cisplatin were r and omized to receive either epoetin beta 10,000 IU thrice weekly and oral iron starting 10 - 15 days before their 5-week course of whole pelvic irradiation and weekly cisplatin ( treatment arm ) or st and ard supportive care ( control arm ) , where epoetin beta was not given . Blood transfusion was given in patients of both the arms if hemoglobin was = 10 g/dl . Conclusions : Treatment with epoetin beta safely and effectively corrects anemia in patients with advanced cervical cancer receiving chemoradiotherapy and is not associated with adverse effects on response rate , overall survival , disease free survival and chemoradiotherapy related acute and late toxicities",
"Summary . This phase 3 , r and omized , double‐blind , placebo‐controlled study was design ed to evaluate the efficacy and safety of darbepoetin alfa in anaemic patients with lymphoproliferative malignancies . Patients ( n = 344 ) with lymphoma or myeloma received darbepoetin alfa 2·25 μg/kg or placebo s.c . , once weekly for 12 weeks . The percentage of patients achieving a haemoglobin response was significantly higher in the darbepoetin alfa group ( 60 % ) than in the placebo group ( 18 % ) ( P increased responsiveness was observed in patients with lower baseline erythropoietin levels . Darbepoetin alfa also result ed in higher mean changes in haemoglobin than placebo from baseline to the last value during the treatment phase ( 1·80 g/dl vs 0·19 g/dl ) and after 12 weeks of treatment ( 2·66 g/dl vs 0·69 g/dl ) . A significantly lower percentage of patients in the darbepoetin alfa group received red blood cell transfusions than in the placebo group ( P efficacy of darbepoetin alfa was consistent for patients with lymphoma or myeloma . Improvements in quality of life were also observed with darbepoetin alfa . The overall safety profile of darbepoetin alfa was consistent with that expected for this patient population . Darbepoetin alfa significantly increased haemoglobin and reduced red blood cell transfusions in patients with lymphoproliferative malignancies receiving chemotherapy ",
"Trials of anemia correction in chronic kidney disease have found either no benefit or detrimental outcomes of higher targets . We did a secondary analysis of patients with chronic kidney disease enrolled in the Correction of Hemoglobin in the Outcomes in Renal Insufficiency trial to measure the potential for competing benefit and harm from achieved hemoglobin and epoetin dose trials . In the 4 month analysis , significantly more patients in the high-hemoglobin compared to the low-hemoglobin arm were unable to achieve target hemoglobin and required high-dose epoetin-alpha . In unadjusted analyses , the inability to achieve a target hemoglobin and high-dose epoetin-alpha were each significantly associated with increased risk of a primary endpoint ( death , myocardial infa rct ion , congestive heart failure or stroke ) . In adjusted models , high-dose epoetin-alpha was associated with a significant increased hazard of a primary endpoint but the risk associated with r and omization to the high hemoglobin arm did not suggest a possible mediating effect of higher target via dose . Similar results were seen in the 9 month analysis . Our study demonstrates that patients achieving their target had better outcomes than those who did not ; and among subjects who achieved their r and omized target , no increased risk associated with the higher hemoglobin goal was detected . Prospect i ve studies are needed to confirm this relationship and determine safe dosing algorithms for patients unable to achieve target hemoglobin",
"BACKGROUND Anaemia is associated with poor cancer control , particularly in patients undergoing radiotherapy . We investigated whether anaemia correction with epoetin beta could improve outcome of curative radiotherapy among patients with head and neck cancer . METHODS We did a multicentre , double-blind , r and omised , placebo-controlled trial in 351 patients ( haemoglobin curative radiotherapy at 60 Gy for completely ( R0 ) and histologically incomplete ( R1 ) resected disease , or 70 Gy for macroscopically incompletely resected ( R2 ) advanced disease ( T3 , T4 , or nodal involvement ) or for primary definitive treatment . All patients were assigned to subcutaneous placebo ( n=171 ) or epoetin beta 300 IU/kg ( n=180 ) three times weekly , from 10 - 14 days before and continuing throughout radiotherapy . The primary endpoint was locoregional progression-free survival . We assessed also time to locoregional progression and survival . Analysis was by intention to treat . FINDINGS 148 ( 82 % ) patients given epoetin beta achieved haemoglobin concentrations higher than 140 g/L ( women ) or 150 g/L ( men ) compared with 26 ( 15 % ) given placebo . However , locoregional progression-free survival was poorer with epoetin beta than with placebo ( adjusted relative risk 1.62 [ 95 % CI 1.22 - 2.14 ] ; p=0.0008 ) . For locoregional progression the relative risk was 1.69 ( 1.16 - 2.47 , p=0.007 ) and for survival was 1.39 ( 1.05 - 1.84 , p=0.02 ) . INTERPRETATION Epoetin beta corrects anaemia but does not improve cancer control or survival . Disease control might even be impaired . Patients receiving curative cancer treatment and given erythropoietin should be studied in carefully controlled trials",
"Anaemia is common in patients receiving chemotherapy , causing symptoms that have a major impact on quality of life ( QoL ) . Epoetin beta rapidly increases haemoglobin ( Hb ) levels and improves QoL in anaemic patients with a variety of tumours . This was a r and omized , double-blind , parallel-group , dose-finding study assessing the efficacy and safety of once-weekly epoetin beta in patients with solid tumours receiving chemotherapy . Adult patients with anaemia ( Hb to receive epoetin beta 30,000 IU or 20,000 IU once weekly for 12 weeks . All patients received oral iron supplementation . Haemoglobin levels , transfusion need and QoL [ Functional Assessment of Cancer Therapy-fatigue ( FACT-F ) subscale score ] were assessed at regular intervals . Fifty patients were r and omized ; 30 patients received epoetin beta 30,000 IU once weekly and 20 received 20,000 IU once weekly . Mean ( + /- SD ) increase in Hb from baseline to week 12 was 1.75 + /- 2.15 g/dL in the 30,000 IU group ( P = 0.008 vs. baseline ) and 1.04 + /- 1.75 g/dL in the 20,000 IU group ( non-significant ) . Haemoglobin response ( increase in Hb > or=2 g/dL from baseline ) was observed in 78.3 % of patients receiving epoetin beta 30,000 IU and 66.7 % receiving epoetin beta 20,000 IU . Improvements in FACT-F subscale score were significantly ( P Hb level . Transfusion use was low during the study in both groups . Both epoetin beta regiments were well tolerated and there were no dose-dependent adverse events . Epoetin beta 30,000 IU once weekly is an effective and well-tolerated treatment of anaemia in patients with solid tumours",
"Introduction : This study evaluated the safety/efficacy of once-weekly ( QW ) epoetin alfa measured by quality of life ( QOL ) , hemoglobin ( Hb ) , transfusion incidence , tumor response , and survival in patients with chemotherapy-naïve , advanced non-small cell lung cancer ( NSCLC ) . Methods : Stage IIIB/IV NSCLC patients with Hb ≥11 to to subcutaneously receive 40,000 U of epoetin alfa QW at chemotherapy initiation ( immediate ) or no epoetin alfa unless Hb decreased to ≤10 g/dl ( delayed ) . The primary efficacy variable was change in QOL for immediate versus delayed intervention . Target accrual was 320 patients . Results : The study was terminated early because of slow accrual ; of 216 patients enrolled , 211 were evaluable for efficacy . Hb was maintained in the immediate group , but it decreased in the delayed group ( 12.9 versus 11.6 g/dl final values , respectively ) . Numerically , fewer immediate patients required transfusions versus delayed patients . Mean QOL scores , modestly declining in both groups from baseline to final measurement , were not significantly different between groups . Tumor response and median overall survival were similar between groups . Epoetin alfa was well tolerated , with a similar thrombovascular event rate between groups . Conclusion : Epoetin alfa in subcutaneous doses of 40,000 U QW , given immediately at chemotherapy initiation for advanced NSCLC , was well tolerated , and it effectively maintained Hb , leading to a reduced transfusion incidence versus delayed epoetin alfa . Overall QOL scores were higher than typical in this population , decreasing slightly during treatment in both groups . Overall survival was similar between groups , with no evidence of a negative effect by early epoetin alfa intervention",
"This r and omized , controlled trial evaluated the effect of darbepoetin alfa on hospitalization days , transfusion requirements , hemoglobin levels , and fatigue in patients with anemia of cancer ( AOC ) . Eligible patients were anemic ( hemoglobin or=18 years old , and had not received chemotherapy or radiotherapy within 4 weeks of study screening . Patients were r and omized 4:1 to receive darbepoetin alfa , 3.0 microg/kg every 2 weeks ( Q2W ) ( n = 226 ) , or observation only for 12 weeks ( n = 59 ) , followed by an optional 9 weeks of darbepoetin alfa , 3.0 microg/kg Q2W . Endpoints were compared between the two treatment arms at week 13 . A planned interim analysis indicated that assumptions regarding hospitalization in the study design were incorrect , so the study was terminated early . Therefore , results for the primary endpoint should be interpreted cautiously . The hospitalization rate was similar ( 0.5 days ) for both the darbepoetin alfa and observation groups ( p = .73 ) . Transfusion incidence ( weeks 5 - 12 ) was significantly lower for darbepoetin alfa patients ( 8 % ) than for observation patients ( 22 % ) ( p = .0092 ) . By week 13 , hemoglobin increased by 2.1 g/dl in patients receiving darbepoetin alfa , compared with 0.1 g/dl in the observation group p Hemoglobin improvements were paralleled by an increase in Functional Assessment of Cancer Therapy-Fatigue score ( mean change in score at week 13 : darbepoetin alfa , 6.0 ; observation , 2.2 ; p Darbepoetin alfa Q2W can significantly improve hemoglobin levels and reduce transfusion requirements in patients with AOC , result ing in significant improvements in health-related quality of life",
"8064 Background : Darbepoetin alfa ( DA , Aranesp ® ) administered Q3W is effective for the treatment of CIA ( Kotasek et al , 2003 ) . NCCN guidelines recommend initiating erythropoietic therapy when hemoglobin ( Hb ) is DA to maintain Hb ≥ 10 g/dL in mildly anemic pts ( early intervention ) and pts who become moderately to severely anemic before treatment ( late intervention ) . METHODS Pts with baseline Hb ≥ 10.5 and ≤ 12 g/dL were r and omized 1:1 to early ( DA 300 mcg Q3W ) or late intervention ( treated if Hb ≤ 10 g/dL with DA 300 mcg Q3W ) groups for up to 23 weeks . The primary endpoint was the percentage of pts in each group with a Hb drop below 10 g/dL. Patient-reported outcomes included the FACT-Fatigue subscale . Proportion endpoints were calculated using Kaplan-Meier ( KM ) methods . RESULTS The study is fully enrolled with 204 pts . Data through week 17 for 201 evaluable pts ( 99 early and 102 late ) were analyzed . Mean ( SD ) baseline Hb for early pts was 11.1 ( 0.7 ) g/dL and 11.2 ( 0.6 ) g/dL for late pts . There was a significant ( P the K-M proportion ( 95 % CL ) of pts with a Hb drop maintained average Hb within the NCCN target range while late pts required DA after a median ( 95 % CL ) of 4.5 ( 3 , 6 ) weeks after r and omization . Thus , late pts achieved the NCCN target range after an average of 2 DA doses . The KM proportion ( 95 % CL ) for transfusions was lower for early pts ( 14 % ; 7 , 20 ) compared with late pts ( 22 % ; 13 , 30 ) . Early pts also performed better on the FACT-Fatigue . CONCLUSIONS These results suggest that DA 300 mcg Q3W is well tolerated and effective in achieving and maintaining Hb levels at a target level of 11 - 12 g/dL. In addition , early intervention results in fewer transfusions and greater symptom improvement compared with late intervention . The availability of a Q3W schedule for erythropoietic therapy can simplify the management of anemia and provide benefits for CIA pts and their caregivers . [ Table : see text ]",
"PURPOSE This r and omized , double-blind , placebo-controlled clinical trial assessed the effects of epoetin alfa on transfusion requirements , hematopoietic parameters , quality of life ( QOL ) , and safety in anemic cancer patients receiving nonplatinum chemotherapy . The study also explored a possible relationship between increased hemoglobin and survival . PATIENTS AND METHODS Three hundred seventy-five patients with solid or nonmyeloid hematologic malignancies and hemoglobin levels or = 1.5 g/dL per cycle since starting chemotherapy , were r and omized 2:1 to epoetin alfa 150 to 300 IU/kg ( n = 251 ) or placebo ( n = 124 ) three times per week subcutaneously for 12 to 24 weeks . The primary end point was proportion of patients transfused ; secondary end points were change in hemoglobin and QOL . The protocol was amended before unblinding to prospect ively collect and assess survival data 12 months after the last patient completed the study . RESULTS Epoetin alfa , compared with placebo , significantly decreased transfusion requirements ( P = .0057 ) and increased hemoglobin ( P cancer- and anemia-specific QOL domains , including energy level , ability to do daily activities , and fatigue , was significantly ( P survival as an end point , Kaplan-Meier estimates showed a trend in overall survival favoring epoetin alfa ( P = .13 , log-rank test ) , and Cox regression analysis showed an estimated hazards ratio of 1.309 ( P = .052 ) favoring epoetin alfa . Adverse events were comparable between groups . CONCLUSION Epoetin alfa safely and effectively ameliorates anemia and significantly improves QOL in cancer patients receiving nonplatinum chemotherapy . Encouraging results regarding increased survival warrant another trial design ed to confirm these findings",
"PURPOSE A placebo-controlled , double-blind , r and omized , phase III study was conducted in patients with extensive-stage small-cell lung cancer receiving first-line platinum-containing chemotherapy to determine if increasing or maintaining hemoglobin concentration with darbepoetin alpha could increase patient survival . PATIENTS AND METHODS Darbepoetin alpha ( 300 microg ) or placebo was administered once per week for 4 weeks then every 3 weeks for up to six cycles of chemotherapy ( carboplatin plus etoposide or cisplatin plus etoposide ) plus 3 weeks after the last dose of chemotherapy . Patients with disease progression were observed until death or until all patients completed their end-of- study visit and 496 deaths had occurred . The two co primary end points were change in hemoglobin concentration from baseline to the end of the chemotherapy period and overall survival ; statistical testing of survival was done if change in hemoglobin was significant at P The study enrolled 600 patients . Patients ' hemoglobin levels dropped due to the myelosuppressive chemotherapy ; however , treatment with darbepoetin alpha maintained hemoglobin levels significantly higher than placebo ( P overall survival between the treatment groups ( hazard ratio [ HR ] , 0.93 ; 95 % CI , 0.78 to 1.11 ; P = .431 ) . As expected , darbepoetin alpha was associated with a higher incidence of thromboembolic events ( darbepoetin alpha , 9 % ; placebo , 5 % ) . The transfusion risk was lower in the darbepoetin versus placebo group ( HR , 0.40 ; 95 % CI , 0.29 to 0.55 ) . CONCLUSION The results of this study did not demonstrate improved survival after treatment with darbepoetin alpha ; however , they reinforce the benefit of erythropoiesis-stimulating agents in reducing transfusions and their neutral impact on survival in patients with chemotherapy-induced anemia",
"ABSTRACT Objective : Darbepoetin alfa is effective in treating chemotherapy-induced anemia ( CIA ) . Administration of subcutaneous darbepoetin alfa every 3 weeks ( Q3W ) could simplify treatment through synchronization with common Q3W chemotherapy regimens . We report results from a multicenter , r and omized , double-blind , placebo-controlled , phase 3 trial evaluating the efficacy and safety of fixed-dose Q3W darbepoetin alfa in patients with a wide variety of tumor types who experienced CIA . Research design and methods : Patients aged ≥ 18 years with anemia ( hemoglobin to receive darbepoetin alfa 300 μg ( n = 193 ) or placebo ( n = 193 ) subcutaneously Q3W from weeks 1 to 13 in this 16-week study . Doses could be adjusted per prespecified rules . Main outcome measures : The primary endpoint was the proportion of patients who received ≥1 red blood cell ( RBC ) transfusion between week 5 and the end of the treatment period ( EOTP ) . The study also analyzed the proportions of patients achieving a hemoglobin concentration ≥11 g/dL and subsequently maintaining hemoglobin levels above 11 g/dL , and the change in hemoglobin concentration over time . Results : The proportion of patients requiring RBC transfusions between week 5 and EOTP was significantly lower in the darbepoetin alfa-treated group than in the placebo-treated group ( 24 vs. 41 % of patients , a 16.3 % difference , p arms in quality -of-life measures . Cardiovascular/thromboembolic adverse events were uncommon and were not associated with increases in hemoglobin levels . Study limitations suggest caution in the interpretation of these results : transfusions , the primary endpoint , were recommended but not required if hemoglobin concentrations were ≤8.0 g/dL , and protocol deviations ( primarily dosing errors ) occurred in approximately one-half of the patients in both treatment groups . Conclusions : In this study , fixed-dose Q3W darbepoetin alfa appeared to be well-tolerated and effective for the treatment of CIA . Trial registration : Clinical Trials.gov identifier : NCT00110955",
"PURPOSE To determine whether the addition of recombinant human erythropoietin ( Epo ) could improve the outcomes of anemic patients receiving definitive radiotherapy for squamous cell carcinoma of the head and neck ( SCCHN ) . METHODS AND MATERIAL S Eligible patients had SCCHN , with a plan for continuous-course definitive radiotherapy ( 66 - 72 Gy ) with or without chemotherapy . Patients with Stage III or IV SCCHN were required to undergo concurrent chemoradiotherapy and /or accelerated fractionation radiotherapy . Preradiotherapy hemoglobin was required to be between 9.0 g/dL and 13.5 g/dL ( 12.5 g/dL for women ) . Patients r and omized to Epo received 40,000 U once weekly , starting 7 - 10 days before start of radiotherapy . RESULTS A total of 148 patients were enrolled ; 141 were evaluable . Median pretreatment hemoglobin was 12.1 g/dL. Hemoglobin levels at 4 weeks rose by an average of 1.66 g/dL in the Epo arm , compared with an average 0.24 g/dL decrease in the control arm ( p = 0.0001 ) . Median follow-up was 2.5 years ( 3.1 years for surviving patients ) . There was no statistically significant difference in the primary endpoint of local-regional failure ( LRF ) rate between the treatment arms . The 3-year LRF rate was 36 % for control and 44 % for Epo ( p = 0.56 ) . There were also no significant differences in local-regional progression-free survival ( LRPFS ) , patterns of failure , overall survival , or toxicity . The 3-year LRPFS rate was 52 % for control and 47 % for Epo . The overall survival rate was 57 % and 56 % , respectively . CONCLUSIONS The addition of Epo to definitive radiotherapy for SCCHN did not improve outcomes . The study was not specifically design ed to detect a potential negative association between Epo and tumor progression/survival",
"The optimal hemoglobin concentration at which to initiate erythropoietic therapy for chemotherapy-induced anemia ( CIA ) is not well defined . This r and omized , open-label , multicenter study evaluated the ability of darbepoetin alfa ( 300 microg every 3 weeks ) to maintain hemoglobin levels > or = 10 g/dl in patients with CIA ( hemoglobin > or = 10.5 g/dl and to an immediate-intervention group ( received darbepoetin alfa immediately ) or observation group ( received darbepoetin alfa if hemoglobin fell to 201 evaluable patients , there was a significant difference between the two groups in the Kaplan-Meier proportion of patients with a hemoglobin decrease to Sixty-four patients in the observation group received darbepoetin alfa ( delayed-intervention subgroup ) . The Kaplan-Meier proportion of patients who received transfusions was lower in the immediate-intervention group than in the delayed-intervention subgroup ( 14 % versus 31 % for the test period ; 17 % versus 36 % over the whole study ) . The target hemoglobin level ( > or = 11 g/dl ) was achieved by a higher percentage of patients ( crude percentage ) in less time in the immediate-intervention group ( 94 % in 2 weeks ) than in the delayed-intervention subgroup ( 73 % in 6 weeks ) ; hemoglobin endpoints for the delayed-intervention subgroup were calculated from recalibrated study week 1 ( the date patients first received darbepoetin alfa ) . For both groups , a higher mean change in hemoglobin from baseline led to a greater improvement in Functional Assessment of Cancer Therapy-Fatigue scores . In conclusion , immediate intervention result ed in a significantly lower proportion of patients who experienced a decline in hemoglobin , lower requirement for transfusions , and greater proportion of patients achieving and maintaining the target hemoglobin level",
"Abstract . Objective : To compare the pharmacokinetics , pharmacodynamics , and tolerance of epoetin alfa administered subcutaneously ( s.c . ) once weekly ( q.w . ) and three times weekly ( t.i.w . ) . Methods : An open-label , r and omized , parallel- design study was conducted in 36 healthy adults with hemoglobin ( Hb ) levels of 11.7–14.0 g/dl for women and 13.0–14.8 g/dl for men . Subjects were r and omized to epoetin alfa 150 IU/kg s.c . t.i.w . or 40,000 IU s.c . q.w . for 4 weeks . Serum erythropoietin concentrations were measured using a vali date d enzyme-linked immunosorbent assay ( ELISA ) . Pharmacokinetic parameters [ peak serum concentration ( Cmax ) , mean predose trough concentration ( Cmin ) , time to Cmax ( tmax ) , clearance after s.c . administration ( CL/F ) , area under the plasma concentration – time curve ( AUC ) , and terminal elimination half-life ( t1/2 ) ] were calculated using model-independent methods . Mean changes from baseline and AUC of percentage reticulocytes , Hb , and total red blood cell ( RBC ) concentrations over the 1-month study period were calculated . Results : The Cmax values for serum epoetin alfa q.w . were six times and AUC(0–168 ) values three times that of the t.i.w . regimen . Time profiles of changes in percentage reticulocytes , Hb , and total RBC over 1 month were similar between regimens . The rate of increase in Hb was similar for the two groups , and both groups exhibited a 3.1-g/dl increase in mean Hb levels from baseline through day 29 . Changes in ferritin levels were generally similar between groups and reflected expected use of iron stores for Hb production . Epoetin alfa administered t.i.w . or q.w . was well tolerated and no serious adverse events occurred . Conclusion : The pharmacodynamic responses were equivalent between groups despite expected differences in total erythropoietin exposure . These results indicate that the epoetin alfa 150 IU/kg t.i.w . and 40,000 IU q.w . regimens can be considered clinical ly equivalent",
"BACKGROUND Erythropoietin corrects and prevents anemia and decreases the need for red blood cell ( RBC ) transfusions ; its impact on quality of life ( QOL ) of cancer patients receiving chemotherapy is not clear . PATIENTS AND METHODS 399 patients with solid tumors and Hb level of to receive or not 10,000 IU epoetin-alpha thrice weekly . QOL was measured by the Functional Assessment of Cancer Therapy-Anemia ( FACT-An ) scale and various subscales at baseline , at two months and at the end of the study . RESULTS Changes in the average QOL scores were similar in the two groups . The improvement in Hb levels was significantly higher for the epoetin-alpha group , with a decrease in transfusion requirements compared to the control group . CONCLUSION Epoetin-alpha does not improve QOL of patients with solid tumors receiving chemotherapy as assessed using FACT-An scale and various subscales , despite improving Hb levels and reducing transfusion requirements",
"Recombinant human erythropoietin ( r-HuEPO ) was administered in two phases to 12 patients with chronic renal insufficiency ( creatinine clearances of 0.17–0.51 ml/second [ 10–30 ml/minute ] ) and uremic anemia . In addition to the routine tests done as part of a multicenter clinical trial , our patients had serial red cell mass measurements , quantitation of bone marrow stem cells , and marrow cytogenetic analysis . During the first eight weeks ( acute phase ) , an equal number of patients was r and omized to placebo or one of three doses of r-HuEPO ( 50 , 100 or 150 unit/kg intravenously three times weekly ) . All three patients receiving 150 unit/kg responded by increasing their packed cell volume ( PCV ) to the normal range within eight weeks . There were lesser responses in PCV at the two lower doses of r-HuEPO and no response in the placebo group . The 51Cr red cell mass also increased significantly in a dose-related manner in patients receiving r-HuEPO but did not change in the placebo group . Marrow studies revealed increases in erythroid , megakaryocyte , and granulocyte-monocyte progenitor cells in those patients on r-HuEPO , but no mutagenic effects were seen . Subsequently , ten patients received open label r-HuEPO . During this maintenance phase , all ten achieved or maintained a normal PCV . Several adverse events occurred , but none were definitely linked to r-HuEPO . Recombinant human erythropoietin is an effective and potent treatment of anemia caused by renal failure",
"PURPOSE This r and omized , double-blind , placebo-controlled trial ( N93 - 004 ) evaluated the effects of epoetin alfa on tumor response to chemotherapy and survival in patients with small-cell lung cancer ( SCLC ) . PATIENTS AND METHODS Adult patients with hemoglobin received epoetin alfa 150 U/kg or placebo subcutaneously 3 times weekly until 3 weeks after completion of chemotherapy . Survival was assessed for 3 years . The primary end point was the proportion of patients with complete or partial response after three chemotherapy cycles . RESULTS The trial was terminated prematurely after 224 of a projected 400 patients were accrued . Baseline characteristics were similar between groups . Epoetin alfa and placebo patients ( n = 109 and n = 115 , respectively ) had mean baseline hemoglobin of 12.8 g/dL and 13.0 g/dL , respectively . Overall tumor response was similar between the epoetin alfa and placebo groups after three chemotherapy cycles ( 72 % and 67 % , respectively ; 95 % CI of difference , -6 % to 18 % ) and after completion of chemotherapy ( 60 % and 56 % , respectively ; 95 % CI of difference , -9 % to 17 % ) . Epoetin alfa and placebo groups had similar median overall survival ( 10.5 and 10.4 months , respectively ) and overall mortality ( 91.7 % and 87.8 % , respectively ; hazard ratio , 1.172 ; 95 % CI , 0.887 to 1.549 ; P = .264 ) . Hemoglobin was maintained in the prechemotherapy range in epoetin alfa patients , but decreased substantially in placebo patients . Fewer epoetin alfa patients than placebo patients required transfusion . CONCLUSION These results suggest that in newly diagnosed patients with SCLC epoetin alfa does not affect tumor response to chemotherapy or survival . However , the early trial closure makes these conclusions preliminary",
" Chemotherapy‐related anemia is prevalent among patients with hematologic malignancies . A r and omized , open‐label , multicenter trial of early versus late epoetin alfa in this population was conducted , focusing on quality of life ( QOL ) ",
"One hundred twenty-one anemic , transfusion-dependent patients with multiple myeloma ( MM ) or low- grade non-Hodgkin 's lymphoma ( NHL ) were r and omly allocated to receive ( a ) recombinant human erythropoietin ( rhEPO ) 10,000 U/d subcutaneously 7 days a week ( fixed dose group ) ( n = 38 ) , or ( b ) rhEPO 2,000 U/d subcutaneously for 8 weeks followed by step-wise escalation of the rhEPO dose ( titration group ) ( n = 44 ) , or ( c ) no rhEPO therapy ( control group ) ( n = 39 ) . The total treatment period was 24 weeks . There were no differences between the three groups with regard to baseline clinical , demographic , or health status measures . The cumulative response frequency , defined as elimination of the transfusion need in combination with an increase in the hemoglobin concentration by > 20 g/L , was 60 % in both rhEPO treatment groups and 24 % in the control group ( P = .01 and .02 , respectively , log rank test ) . For patients in the titration group the response rate on the first dose level ( 2,000 U/d ) was only 14 % . Cox 's univariate regression analysis revealed that an inadequately low endogenous erythropoietin concentration in relation to the degree of anemia and a baseline platelet concentration > or = 100 x 10(9)/L were significant predictors for response to rhEPO therapy ( P Multivariate regression analysis showed that relative erythropoietin concentration was the most important factor and the platelet count had no additional influence on response . Treatment with rhEPO was well tolerated . We conclude that treatment with rhEPO may be indicated in anemic MM and NHL patients with a relative erythropoietin deficiency . An initial dose of 5,000 U/d subcutaneously may be recommended",
"PURPOSE Previous trials have suggested a quality -of-life ( QOL ) improvement for anemic cancer patients treated with erythropoietin , but few used QOL as the primary outcome . We design ed a trial to investigate the effects of epoetin alfa therapy on the QOL of anemic patients with advanced non-small-cell carcinoma of the lung ( NSCLC ) . PATIENTS AND METHODS A multicenter , r and omized , double-blind , placebo-controlled trial was conducted . The proposed sample size was 300 patients . Eligible patients were required to have NSCLC unsuitable for curative therapy and baseline hemoglobin ( Hgb ) levels less than 121 g/L. Patients were assigned to 12 weekly injections of subcutaneous epoetin alpha or placebo , targeting Hgb levels between 120 and 140 g/L. The primary outcome was the difference in the change in Functional Assessment of Cancer Therapy-Anemia scores between baseline and 12 weeks . RESULTS Reports of thrombotic events in other epoetin trials prompted an unplanned safety analysis after 70 patients had been r and omly assigned ( 33 to the active arm and 37 to the placebo arm ) . This revealed a significant difference in the median survival in favor of the patients on the placebo arm of the trial ( 63 v 129 days ; hazard ratio , 1.84 ; P = .04 ) . The Steering Committee closed the trial . Patient numbers compromised the interpretation of the QOL analysis , but a positive Hgb response was noted with epoetin alfa treatment . CONCLUSION An unplanned safety analysis suggested decreased overall survival in patients with advanced NSCLC treated with epoetin alfa . Although infrequent , other similar reports highlight the need for ongoing trials evaluating erythropoietin receptor agonists to ensure that overall survival is monitored closely",
"INTRODUCTION ADVANCED CANCER is frequently associated with significant anaemia which may be worsened by the administration of chemotherapy with myelotoxic agents such as methotrexate or nephrotoxic agents such as cisplatin . Although anaemia in cancer patients may be multifactorial in origin , it is often categorised as the anaemia of chronic disease ( ACD ) [ 1,2 ] . ACD is characterised by erythroid hypoplasia of the bone marrow , a modest decrease in red cell survival , decreased bone marrow reutilization of iron , and inappropriately low erythropoietin levels for the degree of anaemia [ 2 ] . Consistent with this A C D model , i napp rop r i a t e ly low se rum erythropoietin levels for the degree of anaemia have recently been documented in cancer patients [ 3 ] . The symptomato logy of anaemia may con t r ibu t e substantially to the overall lack of well-being that cancer patients frequently experience during their disease process . The t ransfusions often required for pal l ia t ion of these symptoms carry significant risks . There is an estimated 20 % probability of some associated adverse effect including fever , chills , rash , urticaria and exposure to hepatitis [ 4 ] . The scope of this problem is substantial when one considers that the annual transfusion estimate for this patient group in the U.S.A. alone is one million units of red blood cells/whole blood [ 5 ] . The observation that , at any given haemoglobin level , serum erythropoiet in levels tend to be lower in cancer patients than in iron deficiency patients [ 3 ] suggests that anaemia in cancer is at least partially due to a relative deficiency of e ry thropoie t in . In c o n j u n c t i o n with this observation , recent work demonstrating both the eft]caw and safety of recombinant human erythropoietin ( r-HuEPO ) in increasing haematocrit in anaemic patients with chronic renal failure [ 6,7 ] and in anaemic , zidovudine (AZT)-treated HIVinfected patients [ 8 ] offers the possibility that exogenous erythropoietin may also be an effective treatment for anaemia in cancer patients . To test this possibility , we conducted a series of double-blind , placebo-controlled trials using r-HuEPO in anaemic cancer patients in three different patient population s to examine the safety of r-HuEPO treatment , and its impact on haematocrit , t ransfusion requi rements and quality of life . The three populat ions were : pat ients receiving no chemotherapy , pa t i en t s rece iv ing cyclic n o n c i s p l a t i n c o n t a i n i n g chemothe rapy and pa t ients receiving cyclic c isp la t incontaining chemotherapy",
"BACKGROUND The influence of two regimens of erythropoetin beta on haemoglobin level , quality of life ( QoL ) and side-effects in patients with gynaecological malignancies was assessed . PATIENTS AND METHODS A total of 119 patients during chemotherapy were r and omised to either st and ard therapy with 10,000 IU erythropoetin beta three times a week ( group A ) or 20,000 IU twice a week ( group B ) . Haemoglobin level and QoL were measured . Characteristics of the study population were analysed with descriptive statistical methods . Analysis of variance for repeated measurements was performed with haemoglobin level as dependent variable , and time and study arms as factors . RESULTS The rise in haemoglobin levels and QoL improvement were significant , without any difference between study arms . Adverse events were similar , except significantly more thromboembolic events in group B ( 0 vs. 8 events ; p = 0.003 ) . CONCLUSION Our results show similar improvements in haemoglobin level and QoL , but raise the question whether less frequent dosing regimes may result in increased rates of thromboembolic events",
"BACKGROUND High doses of human recombinant erythropoietin ( rHuEPO ) to achieve hemoglobin levels greater than 13 g/dL in patients with chronic kidney disease appear to be associated with increased mortality . STUDY DESIGN We conducted logistic regression and survival analyses in a retrospective cohort of long-term hemodialysis patients to examine the hypothesis that the induced iron depletion with result ant relative thrombocytosis may be a possible contributor to the link between the high rHuEPO dose-associated hemoglobin level of 13 g/dL or greater and mortality . SETTING & PARTICIPANTS The national data base of a large dialysis organization ( DaVita ) with 40,787 long-term hemodialysis patients during July to December 2001 and their survival up to July 2004 were examined . PREDICTORS Hemoglobin level , platelet count , and administered rHuEPO dose during each calendar quarter . OUTCOMES & OTHER MEASUREMENTS Case-mix-adjusted 3-year all-cause mortality and measures of iron stores , including serum ferritin and iron saturation ratio . RESULTS Higher platelet count was associated with lower iron stores and greater prescribed rHuEPO dose . Compared with a hemoglobin level of 12 to 13 g/dL , a hemoglobin level of 13 g/dL or greater was associated with increased mortality in the presence of relative thrombocytosis , ie , platelet count of 300,000/microL or greater ( case-mix-adjusted death-rate ratio , 1.21 ; 95 % confidence limits , 1.02 to 1.44 ; P = 0.03 ) as opposed to the absence of relative thrombocytosis ( death-rate ratio , 1.04 ; 95 % confidence limits , 0.98 to 1.08 ; P = 0.1 ) . A prescribed rHuEPO dose greater than 20,000 U/wk was associated with a greater likelihood of iron depletion ( iron saturation ratio relative thrombocytosis ( case-mix-adjusted odds ratio , 2.53 ; 95 % confidence limits , 2.37 to 2.69 ; and 1.36 ; 95 % confidence limits , 1.30 to 1.42 , respectively ; P mortality during 3 years ( death-rate ratio , 1.59 ; 95 % confidence limits , 1.54 to 1.65 ; P rHuEPO doses to achieve hemoglobin levels of 13 g/dL or greater in long-term hemodialysis patients . R and omized trials are needed to test these observational associations",
"BACKGROUND Patients with advanced cancer frequently experience clinical ly significant anemia , which is often exacerbated by myelosuppressive chemotherapy . Consistent with the anemia of chronic disease , studies have documented serum erythropoietin levels that are inappropriately low for the degree of anemia in cancer patients . Myelosuppressive chemotherapy impairs erythropoiesis , which may not fully recover between treatment cycles . Recombinant human erythropoietin ( rHuEPO ) has been used safely and effectively to treat anemia in AIDS patients receiving zidovudine ( AZT ) and in patients with chronic renal failure . PURPOSE This study was design ed to evaluate the clinical role of rHuEPO in reducing symptomatic anemia in patients with advanced cancer who were receiving myelosuppressive chemotherapy ( excluding cisplatin ) . METHODS We studied 153 anemic cancer patients receiving cyclic combination chemotherapy in a prospect i ve multicenter , double-blind , placebo-controlled trial . The patients were r and omly assigned to receive either rHuEPO ( 150 U/kg ) or placebo subcutaneously three times a week for a maximum of 12 weeks or until the hematocrit level increased to 38%-40 % . If the hematocrit reached this target level before 12 weeks , the rHuEPO dose could be reduced to maintain the hematocrit at that level for the duration of the study . Response to rHuEPO therapy was assessed by measuring changes in hematocrit level , transfusion requirements , and quality of life . Quality -of-life assessment was based on patients ' responses to question naires before and after the courses of therapy . RESULTS The increase in hematocrit in the rHuEPO-treated group compared with hematocrit in the placebo-treated group was statistically significant ( P = .0001 ) as measured by percentage point of change from baseline to final evaluation , by an increase in hematocrit level of six percentage points or more unrelated to transfusion , and by a rise in hematocrit level to 38 % or more unrelated to transfusion . There was a trend toward the reduction in mean units of blood transfused per patient during months 2 and 3 of therapy combined in rHuEPO-treated patients compared with placebo-treated patients ( 0.91 U versus 1.65 U ; P = .056 ) . In addition , rHuEPO-treated patients experienced a statistically significant improvement in energy level and ability to perform daily activities ( P toxic effects except for increased incidence of diaphoresis ( P diarrhea ( P = .05 ) in the rHuEPO-treated group . CONCLUSIONS We conclude that rHuEPO is safe and effective for reversing anemia related to advanced cancer or to chemotherapy for cancer",
"PURPOSE To evaluate the effect of epoetin alfa on local disease-free survival ( DFS ) , overall survival ( OS ) , and cancer treatment-related anemia and fatigue in patients with head and neck cancer receiving radical radiotherapy with curative intent . PATIENTS AND METHODS Patients ( N = 301 ) with hemoglobin ( Hb ) less than 15 g/dL were r and omly assigned in a ratio of 1:1 to receive radiotherapy plus epoetin alfa ( 10,000 U subcutaneously [ SC ] three times weekly if baseline Hb was or = 12.5 g/dL ) or radiotherapy alone . Hb levels were monitored weekly . The primary end point was local DFS , defined as the time from r and om assignment to local disease recurrence or death . Secondary efficacy end points included OS , local tumor response , and local tumor control . Patients were followed at 1 , 4 , 8 , and 12 weeks postradiotherapy and annually for 5 years . Cancer treatment-related anemia and fatigue were evaluated with the Functional Assessment of Cancer Therapy-Anemia and Functional Assessment of Cancer Therapy-Head and Neck . Adverse events were recorded up to 12 weeks postradiotherapy . RESULTS Hb levels increased from baseline with epoetin alfa . The median duration of local DFS was not statistically different between groups ( observation , 35.42 months ; epoetin alfa , 31.47 months ; hazard ratio , 1.04 ; 95 % CI , 0.77 to 1.41 ) . Groups did not significantly differ in DFS , OS , tumor outcomes , or cancer treatment-related anemia or fatigue . No new or unexpected adverse events were observed . CONCLUSION Addition of epoetin alfa to radical radiotherapy did not affect survival , tumor outcomes , anemia , or fatigue positively or negatively in patients with head and neck cancer",
"This study compared the effects of early intervention with st and ard use of epoetin alfa on haemoglobin ( Hb ) levels and transfusion requirements in cancer patients receiving chemotherapy . Patients with Hb>10 and were r and omised 1:1 to epoetin alfa ( 40,000 IU , subcutaneously , once weekly ) , initiated within 7d of the start of the first on- study chemotherapy cycle ( defined as early intervention ) versus epoetin alfa when Hb Increases in Hb values were significantly higher with early intervention compared to st and ard therapy from week 6 to 10 ( P percentage of patients receiving blood transfusions was similar in both groups , the amount of blood transfused was almost twice as high in the st and ard epoetin alfa group ( n.s . ) . Early intervention with epoetin alfa was well tolerated and overall survival did not differ significantly between groups . Initiation of epoetin alfa at the onset of chemotherapy and Hb Hb levels significantly versus st and ard therapy",
"PURPOSE Recent reports suggest that cancer control may worsen if erythropoietin is administered . We investigated whether erythropoietin receptor expression on cancer cells may correlate with this unexpected finding . PATIENTS AND METHODS Cancer tissue from patients with advanced carcinoma of the head and neck ( T3 , T4 , or nodal involvement ) and scheduled for radiotherapy was assayed retrospectively for erythropoietin receptor expression by immunohistochemistry . Patients were anemic and r and omized to receive epoetin beta ( 300 U/kg ) or placebo under double-blind conditions , given three times weekly starting 10 to 14 days before and continuing throughout radiotherapy . We administered 60 Gy following complete resection or 64 Gy subsequent to microscopically incomplete resection ; 70 Gy were given following macroscopically incomplete resection or for definitive radiotherapy alone . We determined if the effect of epoetin beta on locoregional progression-free survival was correlated with the expression of erythropoietin receptors on cancer cells using a Cox proportional hazards regression model . RESULTS We studied 154 of 157 r and omly assigned patients ; 104 sample s were positive , and 50 were negative for receptor expression . Locoregional progression-free survival was substantially poorer if epoetin beta was administered to patients positive for receptor expression compared with placebo ( adjusted relative risk , 2.07 ; 95 % CI , 1.27 to 3.36 ; P outcome in receptor-negative patients ( adjusted relative risk , 0.94 ; 95 % CI , 0.47 to 1.90 ; P = .86 ) . The difference in treatment associated relative risks ( 2.07 v 0.94 ) was borderline statistically significant ( P = .08 ) . CONCLUSION Erythropoietin might adversely affect prognosis of head and neck cancer patients if cancer cells express erythropoietin receptors",
"BACKGROUND Epoetin-alpha initiated once weekly , followed by once-every-3-weeks maintenance , was effective and well tolerated for chemotherapy-induced anemia . This study evaluated a starting dose of epoetin-alpha 120,000 U once every 3 weeks for chemotherapy-induced anemia using early and late initiation regimens . METHODS Patients with baseline hemoglobin 11.0 - 12.0 g/dL were r and omly assigned to early intervention with immediate epoetin-alpha ( n = 68 ) or to st and ard intervention with epoetin-alpha when hemoglobin decreased to A third group of patients with baseline hemoglobin epoetin-alpha was initiated immediately . The primary endpoint was mean proportion of hemoglobin values within the target range ( 11.0 - 13.0 g/dL ) among r and omized patients . RESULTS The mean proportion of hemoglobin values in range through week 16 was 60 % in each r and omized group . Mean hemoglobin by week showed similar increases over the study . Blood transfusions were administered in 9 % , 8 % , and 24 % of patients in the early , st and ard , and nonr and omized groups . Mean epoetin-alpha doses were similar between treatment groups . Dose reductions and withholds were more common in the early intervention group . Adverse events ( eg , diarrhea , fatigue , nausea ) were consistent with the safety profile for epoetin-alpha . Clinical ly relevant thrombotic vascular events ( regardless of relationship to study treatment ) were reported for 9 % , 12 % , and 12 % of patients in the early , st and ard , and nonr and omized groups . CONCLUSIONS Early and st and ard intervention with epoetin-alpha , administered once every 3 weeks , increased and maintained hemoglobin levels within 11.0 - 13.0 g/dL in patients with chemotherapy-induced anemia",
"BACKGROUND Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease . Although darbepoetin alfa can effectively increase hemoglobin levels , its effect on clinical outcomes in these patients has not been adequately tested . METHODS In this study involving 4038 patients with diabetes , chronic kidney disease , and anemia , we r and omly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo , with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter . The primary end points were the composite outcomes of death or a cardiovascular event ( nonfatal myocardial infa rct ion , congestive heart failure , stroke , or hospitalization for myocardial ischemia ) and of death or end-stage renal disease . RESULTS Death or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo ( hazard ratio for darbepoetin alfa vs. placebo , 1.05 ; 95 % confidence interval [ CI ] , 0.94 to 1.17 ; P=0.41 ) . Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo ( hazard ratio , 1.06 ; 95 % CI , 0.95 to 1.19 ; P=0.29 ) . Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo ( hazard ratio , 1.92 ; 95 % CI , 1.38 to 2.68 ; P patient-reported fatigue in the darbepoetin alfa group as compared with the placebo group . CONCLUSIONS The use of darbepoetin alfa in patients with diabetes , chronic kidney disease , and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes ( either death or a cardiovascular event or death or a renal event ) and was associated with an increased risk of stroke . For many persons involved in clinical decision making , this risk will outweigh the potential benefits . ( Clinical Trials.gov number , NCT00093015 .",
"PURPOSE The concomitant use of intravenous ( IV ) iron as a supplement to erythropoiesis-stimulating agents in patients with chemotherapy-induced anemia is controversial . This study was design ed to evaluate the efficacy and safety of darbepoetin alpha given with IV iron versus with local st and ard practice ( oral iron or no iron ) . PATIENTS AND METHODS In this multicenter , r and omized , open-label , phase III study , 396 patients with nonmyeloid malignancies and hemoglobin ( Hb ) less than 11 g/dL received darbepoetin alpha 500 microg with ( n = 200 ) or without ( n = 196 ) IV iron once every 3 weeks ( Q3W ) for 16 weeks . RESULTS The hematopoietic response rate ( proportion of patients achieving Hb > or= 12 g/dL or Hb increase of > or= 2 g/dL from baseline ) was significantly higher in the IV iron group : 86 % versus 73 % in the st and ard practice group ( difference of 13 % [ 95 % CI , 3 % to 23 % ] ; P = .011 ) . Fewer RBC transfusions ( week 5 to the end of the treatment period ) occurred in the IV iron group : 9 % versus 20 % in the st and ard practice group ( difference of -11 % [ 95 % CI , -18 % to -3 % ] ; P = .005 ) . Both treatments were well tolerated with no notable differences in adverse events . Serious adverse events related to iron occurred in 3 % of patients in the IV iron group and were mostly gastrointestinal in nature . CONCLUSION Addition of IV iron to darbepoetin alpha Q3W in patients with chemotherapy-induced anemia was well tolerated , result ing in an improved hematopoietic response rate and lower incidence of transfusions compared with darbepoetin alpha alone"
] | 41163d64-06ff-11f0-808a-c43d1ab1c353 |
Although regular physical activity ( PA ) is a cornerstone of treatment for type 2 diabetes ( T2D ) , most adults with T2D are sedentary . R and omized controlled trials ( RCTs ) have proven the effectiveness of PA behavioral interventions for adults with T2D but have rarely been conducted in healthcare setting s. We sought to identify PA interventions that are effective and practical to implement in clinical practice setting s. Our first aim was to use the valid Pragmatic-Explanatory Continuum Indicator Summary 2 ( PRECIS-2 ) tool to assess the potential for future implementation of PA interventions in clinical practice setting s. Our second aim was to identify interventions that effectively increased PA and glycemic control among the interventions in the top tertile of PRECIS-2 scores . We search ed PubMed MEDLINE from January 1980 through May 2015 for RCTs of behavioral PA interventions coordinated by clinical practice s for patients with T2D . Dual investigators assessed pragmatism by PRECIS-2 scores , and study effectiveness was extracted from original RCT publications . The PRECIS-2 scores of the 46 behavioral interventions ( n = 13,575 participants ) ranged from 3.0 to 4.8 , where 5 is the most pragmatic score . In the most pragmatic tertile of interventions ( n = 16 ) by PRECIS-2 scores , 30.8 and 31.3 % of interventions improved PA outcomes and hemoglobin A1c , respectively . A minority of published evidence -based PA interventions for adults with T2D were both effective and pragmatic for clinical implementation . These should be tested for dissemination using implementation trial design | [
"Background Many studies have reported significant behavioral impact of physical activity interventions . However , few have examined changes in potential mediators of change preceding behavioral changes , result ing in a lack of information concerning how the intervention worked . Our purpose was to examine mediation effects of changes in psychosocial variables on changes in physical activity in type 2 diabetes patients . Methods Ninety-two patients ( 62 ± 9 years , 30 , 0 ± 2.5 kg/m2 , 69 % males ) participated in a r and omized controlled trial . The 24-week intervention was based on social-cognitive constructs and consisted of a face-to-face session , telephone follow-ups , and the use of a pedometer . Social-cognitive variables and physical activity ( device-based and self-reported ) were collected at baseline , after the 24-week intervention and at one year post-baseline . PA was measured by pedometer , accelerometer and question naire . Results Post-intervention physical activity changes were mediated by coping with relapse , changes in social norm , and social modeling from family members ( p ≤ 0.05 ) . One-year physical activity changes were mediated by coping with relapse , changes in social support from family and self-efficacy towards physical activity barriers ( p ≤ 0.05 ) Conclusions For patients with type 2 diabetes , initiatives to increase their physical activity could usefully focus on strategies for resuming regular patterns of activity , on engaging family social support and on building confidence about dealing with actual and perceived barriers to activity . Trial Registration NCT00903500 , Clinical Trials.gov",
"BACKGROUND Our objective was to test the effect of physicians providing brief health lifestyle counseling to patients with type 2 diabetes mellitus during usual care visits . METHODS We conducted a r and omized controlled trial of a 12-month intervention at 2 large community health centers , enrolling 310 patients with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 25 or greater . In the intervention group , self-management goals for nutrition and physical activity were set using a tailored computer program . Goals were then review ed at each clinic visit by physicians . The control group received only printed health education material s. The main outcome measures included change in physical activity and body weight . RESULTS In the intervention group , recommended levels of physical activity increased from 26 % at baseline to 53 % at 12 months ( P < .001 ) compared with controls ( 30 % to 37 % ; P= .27 ) , and 32 % of patients in the intervention group lost 6 or more pounds at 12 months compared with 18.9 % of controls ( odds ratio , 2.2 ; P= .006 ) . CONCLUSION A brief intervention to increase the dialogue between patients and health care providers about behavioral goals can lead to increased physical activity and weight loss",
"Background The International Diabetes Attitudes , Wishes , and Needs ( DAWN ) programmes have shown the existence of a critical gap in self management support and access to the support system . This study aims to evaluate the effectiveness of the diabetes mellitus ( DM ) self management programme , with partnership between general practice and social work , on clinical outcomes , patient self efficacy and lifestyle behaviours . Methods In this is single blind r and omised controlled trial , subjects were recruited from patients attending general outpatient clinics in the Hospital Authority New Territory East Cluster of Hong Kong . 157 subjects meeting the inclusion criteria completed the study and were r and omly assigned to the experimental or control group . The experimental group underwent the six sessions of weekly DM self management course with emphasis on self efficacy and participatory approach . The outcome measurements included HbA1c concentration , DM self efficacy scale , dietary behaviours , body mass index ( BMI ) , and waist : hip ratio . Results Baseline assessment observed no significant differences between experimental and control groups for the variables related to outcomes . For the experimental group , the proportion of subjects with normal HbA1c increased from 4.5 % ( 3/66 ) at baseline to 28.6 % ( 19/66 ) at week 28 ( p DM self efficacy scale and BMI among the experimental group with significant interaction . Dietary behaviours also improved significantly in the experimental group . Conclusion The DM care model with partnership between general practice and social work demonstrated better diabetic control with improvement of self efficacy and minimisation of risk behaviours . Trial registration Current Controlled Trials IS RCT N78882965",
"Abstract Objective . To study the effectiveness of a comprehensive diabetes programme in general practice that integrates patient-centred lifestyle counselling into structured diabetes care . Design and setting . Cluster r and omised trial in general practice s. Intervention . Nurse-led structured diabetes care with a protocol , record keeping , reminders , and feedback , plus training in motivational interviewing and agenda setting . Subjects . Primary care nurses in 58 general practice s and their 940 type 2 diabetes patients with an HbA1c concentration above 7 % , and a body mass index ( BMI ) above 25 kg/m2 . Main outcome measures . HbA1c , diet , and physical activity ( medical records and patient question naires ) . Results . Multilevel linear and logistic regression analyses adjusted for baseline outcomes showed that despite active nurse participation in the intervention , the comprehensive programme was no more effective than usual care after 14 months , as shown by HbA1c levels ( difference between groups = 0.13 ; CI 20.8–0.35 ) and diet ( fat ( difference between groups = 0.19 ; CI 20.82–1.21 ) ; vegetables ( difference between groups = 0.10 ; CI-0.21–0.41 ) ; fruit ( difference between groups = 20.02 ; CI 20.26–0.22 ) ) , and physical activity ( difference between groups = 21.15 ; CI 212.26–9.97 ) , or any of the other measures of clinical parameters , patient 's readiness to change , or quality of life . Conclusion . A comprehensive programme that integrated lifestyle counselling based on motivational interviewing principles integrated into structured diabetes care did not alter HbA1c or the lifestyle related to diet and physical activity . We thus question the impact of motivational interviewing in terms of its ability to improve routine diabetes care in general practice",
"Background The prevalence of type 2 diabetes is rising worldwide , as has been the global mean fasting plasma glucose level . This study aim ed to evaluate the effectiveness of a structured individual-based lifestyle education ( SILE ) program to reduce the hemoglobin A1c ( HbA1c ) level in type 2 diabetes patients delivered by registered dietitians in primary care clinical setting s. Methods This was a 6-month prospect i ve cluster r and omized controlled trial in a primary care setting with r and omization at the practice level . Twenty general practitioners in 20 clinics in Kanagawa prefecture , Japan , were involved . 193 adults ( 51 % men , mean age 61.3 years ) with type 2 diabetes and HbA1c ≥6.5 % who received treatment in medical clinics were the participants . A SILE program was implemented through 4 sessions with trained registered dietitians during the 6-month study period . Results were compared with those of a control group who received usual care . The primary endpoint was the change in HbA1c levels at 6 months from baseline . Secondary endpoints were the changes at 6 months from baseline in fasting plasma glucose , lipid profile , blood pressure , BMI , energy , and nutrient intakes ( whole day and each meal ) . Intention-to-treat analysis was conducted . Mixed-effects linear models were used to examine the effects of the treatment . Results The mean change at 6 months from baseline in HbA1c was a 0.7 % decrease in the intervention group ( n = 100 ) and a 0.2 % decrease in the control group ( n = 93 ) ( difference −0.5 % , 95%CI : -0.2 % to −0.8 % , p = 0.004 ) . After adjusting for baseline values and other factors , the difference was still significant ( p = 0.003 ~ 0.011 ) . The intervention group had a significantly greater decrease in mean energy intake at dinner compared with the control group and a greater increase in mean vegetable intake for the whole day , breakfast , and lunch as shown in crude and adjusted models . A tendency toward improvement was observed in the other secondary endpoints but the improvement was not statistically significant . These results were confirmed by several sensitivity analyses . Conclusions The SILE program that was provided in primary care setting s for patients with type 2 diabetes result ed in greater improvement in HbA1c levels than usual diabetes care and education . Trial registration",
"OBJECTIVE To determine whether a culturally appropriate clinic- and community-based intervention for African-American women with type 2 diabetes will increase moderate-intensity physical activity ( PA ) . RESEARCH DESIGN AND METHODS In this r and omized controlled trial conducted at seven practice s in central North Carolina , 200 African-American women , > or = 40 years of age with type 2 diabetes , were r and omized to one of three treatment conditions : clinic and community ( group A ) , clinic only ( group B ) , or minimal intervention ( group C ) . The clinic-based intervention ( groups A and B ) consisted of four monthly visits with a nutritionist who provided counseling to enhance PA and dietary intake that was tailored to baseline practice s and attitudes ; the community-based intervention ( group A ) consisted of three group sessions and 12 monthly phone calls from a peer counselor and was design ed to provide social support and reinforce behavior change goals ; and the minimal intervention ( group C ) consisted of educational pamphlets mailed to participants . The primary study outcome was the comparison of PA levels between groups assessed at 6 and 12 months by accelerometer , which was worn while awake for 7 days . RESULTS Totals of 175 ( 88 % ) and 167 ( 84 % ) participants completed PA assessment at 6 and 12 months , respectively . For comparison of PA , the P value for overall group effect was 0.014 . Comparing group A with C , the difference in the average adjusted mean for PA was 44.1 kcal/day ( 95 % CI 13.1 - 75.1 , P = 0.0055 ) . Comparing group B with C , the difference in the average adjusted mean was 33.1 kcal/day ( 95 % CI 3.3 - 62.8 , P = 0.029 ) . The intervention was acceptable to participants : 88 % were very satisfied with clinic-based counseling to enhance PA , and 86 % indicated that the peer counselor 's role in the program was important . CONCLUSIONS The intervention was associated with a modest enhancement of PA and was acceptable to participants",
"Aims /hypothesisThe aim of the study was to clarify whether a therapeutic intervention focused on lifestyle modification affected the incidence of vascular complications in patients with established diabetes . Methods A total of 2,033 eligible Japanese men and women aged 40–70 years with type 2 diabetes from 59 institutes were r and omised to a conventional treatment group ( CON ) , which continued to receive the usual care , and a lifestyle intervention group ( INT ) , which received education on lifestyle modification regarding dietary habits , physical activities and adherence to treatment by telephone counselling and at each outpatient clinic visit , in addition to the usual care . R and omisation and open-label allocation were done by a central computer system . Primary analysis regarding measurements of control status and occurrence of macro- and microvascular complications was based on 1,304 participants followed for an 8 year period . Results Although status of control of most classic cardiovascular risk factors , including body weight , glycaemia , serum lipids and BP , did not differ between groups during the study period , the incidence of stroke in the INT group ( 5.48/1,000 patient-years ) was significantly lower than in the CON group ( 9.52/1,000 patient-years ) by Kaplan – Meier analysis ( p = 0.02 by logrank test ) and by multivariate Cox analysis ( HR 0.62 , 95 % CI 0.39–0.98 , p = 0.04 ) . The incidence of CHD , retinopathy and nephropathy did not differ significantly between groups . Lipoprotein(a ) was another significant independent risk factor for stroke . Conclusions /interpretationThese findings suggest that lifestyle modification had limited effects on most typical control variables , but did have a significant effect on stroke incidence in patients with established type 2 diabetes . Clinical Trial Registration : UMIN-CTR C000000222 Funding : The Ministry of Health , Labour and Welfare ,",
"BACKGROUND Despite an increase in overweight and obesity similar to the civilian population , there have been few r and omized controlled trials examining behavioral weight management interventions in the military setting s. PURPOSE This paper describes the design , intervention development and analysis plan of the Fit Blue study , a r and omized controlled behavioral weight loss trial taking place in the United States Air Force . DESIGN This study compares two adapted versions of the efficacious Look AHEAD Intensive Lifestyle Intervention ( ILI ) , a counselor-initiated condition and a self-paced condition . Also described are the unique steps required when conducting military-based health promotion research and adaptations made to the Look AHEAD intervention to accommo date the military environment . CONCLUSIONS To our knowledge , this is the first translation of the Look AHEAD ILI in the military setting and one of the first translations of the ILI in general . If successful , this intervention could be disseminated to the entire U.S. Military as this project is design ed to overcome the barriers and utilize the facilitators for weight loss that are unique to a military population . Programs vali date d in military population s can have a major public health impact given that with 1.4 million active duty personnel , the Department of Defense is the nation 's largest employer . However , while this intervention is design ed for a military population and there are unique aspects of the military that may enhance weight loss interventions , the diversity of the study population should help inform obesity efforts in both civilian and military setting",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"The increasing prevalence of diabetes and obesity , growing health disparities , and shortage of bilingual and culturally trained health care professionals underscore the role of trained community health workers ( CHWs ) to provide economically sustainable and culturally relevant services . This prospect i ve r and omized design evaluated the relative effectiveness of a CHW intervention among Hispanic persons with newly diagnosed type 2 diabetes , as compared with usual clinic practice in three inner-city health centers . In sum , 189 Hispanic patients newly diagnosed with type 2 diabetes were r and omly assigned to one of three 6-month diabetes management approaches — CHW , case management , and st and ard provider care— and assessed for diabetes-related health measures and clinical indicators at baseline and postintervention . Participants in the CHW group achieved greater improvements than did the controls in program measures : health status , emergency department utilization , dietary habits , physical activity , and medication adherence . They also had 2.9 times greater odds of decreasing body mass index",
"Despite the numerous benefits of physical activity for patients with diabetes , most healthcare providers in busy clinical setting s rarely find time to counsel their patients about it . A Web-based program for healthcare providers can be used as an effective counseling tool , when strategies are outlined for specific stages of readiness for physical activity . Seventy-three adults with type 2 diabetes were r and omly assigned to Web-based intervention , printed- material intervention , or usual care . After 12 weeks , the effects of the interventions on physical activity , fasting blood sugar , and glycosylated hemoglobin were evaluated . Both Web-based and printed material intervention , compared with usual care , were effective in increasing physical activity ( P fasting blood sugar ( P glycosylated hemoglobin ( P printed material intervention and usual care , but not between web-based and printed material intervention . The findings of this study support the value of Web-based and printed material interventions in healthcare counseling . With increasing Web access , the effectiveness of Web-based programs offered directly to patients needs to be tested",
"BACKGROUND Group education for patients with suboptimally controlled diabetes has not been rigorously studied . METHODS A total of 623 adults from Minnesota and New Mexico with type 2 diabetes and glycosylated hemoglobin ( HbA(1c ) ) concentrations of 7 % or higher were r and omized to ( 1 ) group education ( using the US Diabetes Conversation Map program ) , ( 2 ) individual education , or ( 3 ) usual care ( UC ; ie , no assigned education ) . Both education methods covered content as needed to meet national st and ards for diabetes self-management education and were delivered through accredited programs from 2008 to 2009 . General linear mixed-model methods assessed patient-level changes between treatment groups in mean HbA(1c ) levels from baseline to follow-up at 6.8 months . Secondary outcomes included mean change in general health status ( Medical Outcomes Study 12-Item Short Form Health Survey [ SF-12 ] ) , Problem Areas in Diabetes ( PAID ) , Diabetes Self-Efficacy ( DES-SF ) , Recommended Food Score ( RFS ) , and Physical Activity ( PA , min/wk ) . RESULTS Mean HbA(1c ) concentration decreased in all groups but significantly more with individual ( -0.51 % ) than group education ( -0.27 % ) ( P = .01 ) and UC ( -0.24 % ) ( P = .01 ) . The proportion of subjects with follow-up HbA(1c ) concentration lower than 7 % was greater for individual education ( 21.2 % ) than for group ( 13.9 % ) and UC ( 12.8 % ) ( P = .03 ) . Compared with UC , individual education ( but not group ) improved SF-12 physical component score ( + 1.88 ) ( P = .04 ) , PA ( + 42.95 min/wk ) ( P = .03 ) , and RFS ( + 0.63 ) ( P = .05 ) . Compared with group education , individual education reduced PAID ( -3.62 ) ( P = .02 ) and increased self-efficacy ( + 0.1 ) ( P = .04 ) . CONCLUSIONS Individual education for patients with established suboptimally controlled diabetes result ed in better glucose control outcomes than did group education using Conversation Maps . There was also a trend toward better psychosocial and behavioral outcomes with individual education . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00652509",
"Background Physical inactivity is a major public health problem . The It ’s LiFe ! monitoring and feedback tool embedded in the Self-Management Support Program ( SSP ) is an attempt to stimulate physical activity in people with chronic obstructive pulmonary disease or type 2 diabetes treated in primary care . Objective Our aim was to evaluate whether the SSP combined with the use of the monitoring and feedback tool leads to more physical activity compared to usual care and to evaluate the additional effect of using this tool on top of the SSP . Methods This was a three-armed cluster r and omised controlled trial . Twenty four family practice s were r and omly assigned to one of three groups in which participants received the tool + SSP ( group 1 ) , the SSP ( group 2 ) , or care as usual ( group 3 ) . The primary outcome measure was minutes of physical activity per day . The secondary outcomes were general and exercise self-efficacy and quality of life . Outcomes were measured at baseline after the intervention ( 4 - 6 months ) , and 3 months thereafter . Results The group that received the entire intervention ( tool + SSP ) showed more physical activity directly after the intervention than Group 3 ( mean difference 11.73 , 95 % CI 6.21 - 17.25 ; P combination of counseling with the tool proved an effective way to stimulate physical activity . Counseling without the tool was not effective . Future research about the cost-effectiveness and application under more tailored conditions and in other target groups is recommended . Trial Registration Clinical Trials.gov : NCT01867970 , https:// clinical trials.gov/ct2/show/NCT01867970 ( archived by WebCite at http://www.webcitation.org/6a2qR5BSr )",
"Objective To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years . Design Three year follow-up of a multicentre cluster r and omised controlled trial in primary care , with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 731 of the 824 participants included in the original trial were eligible for follow-up . Biomedical data were collected on 604 ( 82.6 % ) and question naire data on 513 ( 70.1 % ) participants . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures The primary outcome was glycated haemoglobin ( HbA1c ) levels . The secondary outcomes were blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , emotional impact of diabetes , and drug use at three years . Results HbA1c levels at three years had decreased in both groups . After adjusting for baseline and cluster the difference was not significant ( difference −0.02 , 95 % confidence interval −0.22 to 0.17 ) . The groups did not differ for the other biomedical and lifestyle outcomes and drug use . The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years ( P life did not differ at three years . Conclusion A single programme for people with newly diagnosed type 2 diabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs . Trial registration Current Controlled Trials IS RCT N17844016",
"AIM Patient education that enhances one 's self-management ability is of utmost importance for improving patient outcomes in chronic diseases . We developed a 12 month self-management education program for type 2 diabetes , based on a previous 6 month program , and examined its efficacy . METHODS A r and omized controlled trial was carried out on out patients with type 2 diabetes from two hospitals who met the criteria and gave consent to participate . They were r and omly divided into an intervention group that followed the program and a control group that followed usual clinical practise . The intervention group received based on the program 's textbook and biweekly telephone calls from a nurse educator throughout the 12 months . RESULTS Of the 50 participants in the intervention group and the 25 participants in the control group , 42 and 23 , respectively , completed the program ( a completion rate of 84.0 % ) . The body weight , HbA1c , self-efficacy , dietary and exercise stages , quality of life , diastolic blood pressure , and total cholesterol level were significant by two-way repeated- measures anova . As for changes over time within the groups , only the intervention group showed significant differences by Friedman 's test . The complication prevention behaviors showed a high implementation rate in the intervention group . The overall evaluation of this program by the participants was very high and , therefore , they highly recognized the need for this type of program . CONCLUSIONS Self-management education works successfully in relation to patients ' behavior modification skills , degree of goal attainment , and self-efficacy , consequently improving their health outcomes",
"OBJECTIVE Despite the importance of self-management support ( SMS ) , few studies have compared SMS interventions , involved diverse population s , or entailed implementation in safety net setting s. We examined the effects of two SMS strategies across outcomes corresponding to the Chronic Care Model . RESEARCH DESIGN AND METHODS A total of 339 out patients with poorly controlled diabetes from county-run clinics were enrolled in a three-arm trial . Participants , more than half of whom spoke limited English , were uninsured , and /or had less than a high school education , were r and omly assigned to usual care , interactive weekly automated telephone self-management support with nurse follow-up ( ATSM ) , or monthly group medical visits with physician and health educator facilitation ( GMV ) . We measured 1-year changes in structure ( Patient Assessment of Chronic Illness Care [ PACIC ] ) , communication processes ( Interpersonal Processes of Care [ IPC ] ) , and outcomes ( behavioral , functional , and metabolic ) . RESULTS Compared with the usual care group , the ATSM and GMV groups showed improvements in PACIC , with effect sizes of 0.48 and 0.50 , respectively ( P improvements in IPC ( effect sizes 0.40 vs. usual care and 0.25 vs. GMV , P improvements in self-management behavior versus the usual care arm ( P fewer bed days per month than the usual care group ( −1.7 days , P = 0.05 ) and the GMV group ( −2.3 days , P less interference with daily activities than the usual care group ( odds ratio 0.37 , P = 0.02 ) . We observed no differences in A1C change . CONCLUSIONS Patient-centered SMS improves certain aspects of diabetes care and positively influences self-management behavior . ATSM seems to be a more effective communication vehicle than GMV in improving behavior and quality of life",
"OBJECTIVE There is enough evidence that physical activity is an effective therapeutic tool in the management of type 2 diabetes . The present study was design ed to vali date a counseling strategy that could be used by physicians in their daily outpatient practice to promote the adoption and maintenance of physical activity by type 2 diabetic subjects . RESEARCH DESIGN AND METHODS The long-term ( 2-year ) efficacy of the behavioral approach ( n = 182 ) was compared with usual care treatment ( n = 158 ) in two matched , r and omized groups of patients with type 2 diabetes who had been referred to our Outpatient Diabetes Center . The outcome of the intervention was consistent patient achievement of an energy expenditure of > 10 metabolic equivalents (METs)-h/week through voluntary physical activity . RESULTS After 2 years , 69 % of the patients in the intervention group ( 27.1 + /- 2.0 METs x h/week ) and 18 % of the control group ( 4.1 + /- 0.8 METs x h/week ) achieved the target ( P BMI ( intervention group 28.9 + /- 0.2 versus control group 30.4 + /- 0.3 kg/m(2 ) ) and HbA(1c ) ( intervention group 7.0 + /- 0.1 versus control group 7.6 + /- 0.1 % ) . CONCLUSIONS This r and omized , controlled study shows that physicians can motivate most patients with type 2 diabetes to exercise long-term and emphasizes the value of individual behavioral approaches in daily practice",
"Aims In 2011 , we demonstrated that an individualized health management system employing advanced medical information technology , design ated ubiquitous (u)-healthcare , was helpful in achieving glycemic control without hypoglycemia in patients with diabetes . Following this , we generated a new multidisciplinary u-healthcare system by upgrading our clinical decision support system ( CDSS ) rule engine and integrating a physical activity-monitoring device and dietary feedback into a comprehensive package . Methods In a r and omized , controlled clinical trial , patients with type 2 diabetes aged over 60 years were assigned r and omly to a self-monitored blood glucose ( SMBG ) group ( N = 50 ) or u-healthcare group ( N = 50 ) for 6 months . The primary endpoint was the proportion of patients achieving glycated hemoglobin ( HbA1c ) were also investigated . The u-healthcare group was educated to use a specially design ed glucometer and an activity monitor that automatically transferred test results to a hospital-based server . An automated CDSS rule engine generated and sent patient-specific messages about glucose , diet , and physical activity to their mobile phones and a Web site . Results After 6 months of follow-up , the HbA1c level was significantly decreased in the u-healthcare group [ 8.0 ± 0.7 % ( 64.2 ± 8.8 mmol/mol ) to 7.3 ± 0.9 % ( 56.7 ± 9.9 mmol/mol ) ] compared with the SMBG group [ 8.1 ± 0.8 % ( 64.9 ± 9.1 mmol/mol ) to 7.9 ± 1.2 % ( 63.2 ± 12.3 mmol/mol ) ] ( P . The proportion of patients with HbA1c was greater in the u-healthcare group ( 26 % ) than in the SMBG group ( 12 % ; P decreased and lipid profiles improved in the u-healthcare group but not in the SMBG group . Conclusion This u-healthcare service provided effective management for older patients with type 2 diabetes ( Clinical Trial . Gov : NCT01137058 )",
"Background Diabetes outcomes are worse for underserved patients from certain ethnic/racial minority population s. Telephonic disease management is a cost-effective strategy to deliver self-management services and possibly improve diabetes outcomes for such patients . Objective We conducted a trial to test the effectiveness of a supplemental telephonic disease management program compared to usual care alone for patients with diabetes cared for in a community health center . Design R and omized controlled trial . Participants All patients had type 2 diabetes , and the majority was Hispanic or African American . Most were urban-dwelling with low socioeconomic status , and nearly all had Medicaid or were uninsured . Measurements Clinical measures included glycemic control , blood pressure , lipid levels , and body mass index . Vali date d surveys were used to measure dietary habits and physical activity . Results A total of 146 patients were r and omized to the intervention and 149 to the control group . Depressive symptoms were highly prevalent in both groups . Using an intention to treat analysis , there were no significant differences in the primary outcome ( HbA1c ) between the intervention and control groups at 12 months . There were also no significant differences for secondary clinical or behavioral outcome measures including BMI , systolic or diastolic blood pressure , LDL cholesterol , smoking , or intake of fruits and vegetables , or physical activity . Conclusions A clinic-based telephonic disease management support for underserved patients with diabetes did not improve clinical or behavioral outcomes at 1 year as compared to patients receiving usual care alone",
"CMAJ • MAY 12 , 2009 • 180(10 ) © 2009 Canadian Medical Association or its licensors E47 R and omized trials have traditionally been broadly categorized as either an effectiveness trial or an efficacy trial , although we prefer the terms “ pragmatic ” and “ explanatory . ” Schwartz and Lellouch described these 2 approaches toward clinical trials in 1967 . These authors coined the term “ pragmatic ” to describe trials that help users choose between options for care , and “ explanatory ” to describe trials that test causal research hypotheses ( i.e. , that a given intervention causes a particular benefit ) . We take the view that , in general , pragmatic trials are primarily design ed to determine the effects of an intervention under the usual conditions in which it will be applied , whereas explanatory trials are primarily design ed to determine the effects of an intervention under ideal circumstances . Thus , these terms refer to a trial ’s purpose and , in turn , structure . The degree to which this purpose is met depends on decisions about how the trial is design ed and , ultimately , conducted . Very few trials are purely pragmatic or explanatory . For example , in an otherwise explanatory trial , there may be some aspect of the intervention that is beyond the investigator ’s control . Similarly , the act of conducting an otherwise pragmatic trial may impose some control result ing in the setting being not quite usual . For example , the very act of collecting data required for a trial that would not otherwise be collected in usual practice could be a sufficient trigger to modify participant behaviour in unanticipated ways . Further , several aspects of a trial are relevant , relating to choices of trial participants , health care practitioners , interventions , adherence to protocol and analysis . Thus , we are left with a multidimensional continuum rather than a dichotomy , and a particular trial may display varying levels of pragmatism across these dimensions . In this article , we describe an effort to develop a tool to assess and display the position of any given trial within the pragmatic – explanatory continuum . The primary aim of this tool is to help trialists assess the degree to which design decisions align with the trial ’s stated purpose ( decision-making v. explanation ) . Our tool differs , therefore , from that of Gartlehner and associates in that it is intended to inform trial design rather than provide a method of classifying trials for the purpose of systematic review s. It can , however , also be used by research funders , ethics committees , trial registers and journal editors to make the same assessment , provided trialists declare their intended purpose and adequately report their design decisions . Hence , reporting of pragmatic trials is addressed elsewhere",
"Background Pedometer-based physical activity programs have been typically delivered in a group format by a behavioral expert . An alternative strategy that builds on existing interactions is delivery through individual consultation by a general practitioner ( GP ) . These two delivery strategies have not been directly compared . Purpose To compare effectiveness of a 12-week physical activity ( PA ) intervention for type 2 diabetes patients delivered by a trained GP via an individual consultation or as group delivery by a behavioral expert . MethodS ixty-seven primary care participants ( mean age = 67.4 years , 70 % male ) from three Belgian general practice s were r and omized into three different treatment arms : ( 1 ) individual consultation ( n = 22 ) with three PA contacts with the patient 's GP ; ( 2 ) group counseling ( n = 21 ) with three PA group sessions delivered by a behavioral expert ; and ( 3 ) a control arm ( n = 24 ) receiving no intervention . Participant inclusion criteria were ≤80 years ; 25–35 kg/m² ; ≤12 % HbA1c and reporting no PA limitations . Outcome measures were pedometer-determined steps/day , self-reported PA , and health parameters ( weight , body mass index , waist circumference , total cholesterol , fasting glucose , and HbA1c ) . Results Group counseling participants increased 1,706 steps/day over baseline significantly ( p ≤ 0.05 ) more than other treatment arms . Moreover , they increased their self-reported PA ( + 82 min/day ) , while control arm participants showed a decrease in PA ( p ≤ 0.05 ) . Participants of the individual consultation had a decrease in waist circumference ( −1.4 cm ) and HbA1c ( −0.32 % ) and a lower increase in total cholesterol ( + 7.2 mg/dl ) compared to the other treatment arms ( all p ≤ 0.05 ) . Conclusion Group counseling in type 2 diabetes patients improved PA , whereas individual consultations had an impact on some health outcomes on the short-term",
"This study examines the effectiveness of a brief self-management intervention to support patients recently diagnosed with type-2 diabetes to achieve sustained improvements in their self-care behaviours . Based on proactive coping , the intervention emphasizes the crucial role of anticipation and planning in maintaining self-care behaviours . In a r and omised controlled trial among recent screen-detected patients , participants who received the intervention were compared with usual-care controls , examining changes in proximal outcomes ( intentions , self-efficacy and proactive coping ) , self-care behaviour ( diet , physical activity and medication ) and weight over time ( 0 , 3 and 12 months ) . Subsequently , the contribution of proactive coping in predicting maintenance of behavioural change was analysed using stepwise hierarchical regression analyses , controlling for baseline self-care behaviour , patient characteristics , and intentions and self-efficacy as measured after the course . The intervention was effective in improving proximal outcomes and behaviour with regard to diet and physical activity , result ing in significant weight loss at 12 months . Furthermore , proactive coping was a better predictor of long-term self-management than either intentions or self-efficacy . Proactive coping thus offers new insights into behavioural maintenance theory and can be used to develop effective self-management interventions ",
"Objective To evaluate the effectiveness of a structured group education programme on biomedical , psychosocial , and lifestyle measures in people with newly diagnosed type 2 diabetes . Design Multicentre cluster r and omised controlled trial in primary care with r and omisation at practice level . Setting 207 general practice s in 13 primary care sites in the United Kingdom . Participants 824 adults ( 55 % men , mean age 59.5 years ) . Intervention A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care . Main outcome measures Haemoglobin A1c levels , blood pressure , weight , blood lipid levels , smoking status , physical activity , quality of life , beliefs about illness , depression , and emotional impact of diabetes at baseline and up to 12 months . Main results Haemoglobin A1c levels at 12 months had decreased by 1.49 % in the intervention group compared with 1.21 % in the control group . After adjusting for baseline and cluster , the difference was not significant : 0.05 % ( 95 % confidence interval −0.10 % to 0.20 % ) . The intervention group showed a greater weight loss : −2.98 kg ( 95 % confidence interval −3.54 to −2.41 ) compared with 1.86 kg ( −2.44 to −1.28 ) , P=0.027 at 12 months . The odds of not smoking were 3.56 ( 95 % confidence interval 1.11 to 11.45 ) , P=0.033 higher in the intervention group at 12 months . The intervention group showed significantly greater changes in illness belief scores ( P=0.001 ) ; directions of change were positive indicating greater underst and ing of diabetes . The intervention group had a lower depression score at 12 months : mean difference was −0.50 ( 95 % confidence interval −0.96 to −0.04 ) ; P=0.032 . A positive association was found between change in perceived personal responsibility and weight loss at 12 months ( β=0.12 ; P=0.008 ) . Conclusion A structured group education programme for patients with newly diagnosed type 2 diabetes result ed in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A1c levels up to 12 months after diagnosis . Trial registration Current Controlled Trials IS RCT N17844016",
"ABSTRACT Background Several trials have demonstrated the efficacy of nurse telephone case management for diabetes ( DM ) and hypertension ( HTN ) in academic or vertically integrated systems . Little is known about the real-world potency of these interventions . Objective To assess the effectiveness of nurse behavioral management of DM and HTN in community practice s among patients with both diseases . Design The study was design ed as a patient-level r and omized controlled trial . Participants Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practice s. Subjects were required to have inadequately controlled DM ( hemoglobin A1c [ A1c ] ≥ 7.5 % ) but could have well-controlled HTN . Interventions All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years , for a total of 12 calls . Intervention patients received tailored DM- and HTN- focused behavioral content ; control patients received non-tailored , non-interactive information regarding health issues unrelated to DM and HTN ( e.g. , skin cancer prevention).Main Outcomes and Measures Systolic blood pressure ( SBP ) and A1c were co- primary outcomes , measured at 6 , 12 , and 24 months ; 24 months was the primary time point . Results Three hundred seventy-seven subjects were enrolled ; 193 were r and omized to intervention , 184 to control . Subjects were 55 % female and 50 % white ; the mean baseline A1c was 9.1 % ( SD = 1 % ) and mean SBP was 142 mmHg ( SD = 20 ) . Eighty-two percent of scheduled interviews were conducted ; 69 % of intervention patients and 70 % of control patients reached the 24-month time point . Expressing model estimated differences as ( intervention – control ) , at 24 months , intervention patients had similar A1c [ diff = 0.1 % , 95 % CI ( −0.3 , 0.5 ) , p = 0.51 ] and SBP [ diff = −0.9 mmH g , 95 % CI ( −5.4 , 3.5 ) , p = 0.68 ] values compared to control patients . Likewise , DBP ( diff = 0.4 mmHg , p = 0.76 ) , weight ( diff = 0.3 kg , p = 0.80 ) , and physical activity levels ( diff = 153 MET-min/week , p = 0.41 ) were similar between control and intervention patients . Results were also similar at the 6- and 12-month time points . Conclusions In nine community fee-for-service practice s , telephonic nurse case management did not lead to improvement in A1c or SBP . Gains seen in telephonic behavioral self-management interventions in optimal setting s may not translate to the wider range of primary care setting",
"BACKGROUND In type 2 diabetes mellitus the aetiology of long-term complications is multifactorial . We carried out a r and omised trial of stepwise intensive treatment or st and ard treatment of risk factors in patients with microalbuminuria . METHODS In this open , parallel trial patients were allocated st and ard treatment ( n=80 ) or intensive treatment ( n=80 ) . St and ard treatment followed Danish guidelines . Intensive treatment was a stepwise implementation of behaviour modification , pharmacological therapy targeting hyperglycaemia , hypertension , dyslipidaemia , and microalbuminuria . The primary endpoint was the development of nephropathy ( median albumin excretion rate > 300 mg per 24 h in at least one of the two-yearly examinations ) . Secondary endpoints were the incidence or progression of diabetic retinopathy and neuropathy . FINDINGS The mean age was 55.1 years ( SD 7.2 ) and patients were followed up for 3.8 years ( 0.3 ) . Patients in the intensive group had significantly lower rates of progression to nephropathy ( odds ratio 0.27 [ 95 % CI 0 - 10 - 0.75 ] ) , progression of retinopathy ( 0.45 [ 0.21 - 0.95 ] ) , and progression of autonomic neuropathy ( 0.32 [ 0.12 - 0.78 ] ) than those in the st and ard group . INTERPRETATION Intensified multifactorial intervention in patients with type 2 diabetes and microalbuminuria slows progression to nephropathy , and progression of retinopathy and autonomic neuropathy . However , further studies are needed to establish the effect of intensified multifactorial treatment on macrovascular complications and mortality",
"OBJECTIVES To compare the effectiveness of group ( GE ) and individual ( IE ) health education in type-2 diabetes patients , and identify the improvement in knowledge , metabolic control and risk factors . DESIGN R and omised clinical trial . SETTING Primary care . Participants . 68 patients with type-2 diabetes , diagnosed 6 months before the start of the study and who had not received GE . Patients aged over 75 , those with sensory , psychological and /or physical deficiencies and those not monitored in primary care were excluded ( alpha=0.05 ; beta=0.2 ) . Interventions . Patients were selected according to the inclusion criteria and allocated at r and om to the IE ( n=33 ) or GE ( n=35 ) group . Individual and group lessons were given at the same time for a year . The contents were evaluated with a vali date d , self-administered test . MAIN MEASUREMENTS General , demographic variables , analyses , blood pressure , the Body Mass Index ( BMI ) , the presence of cardiovascular risk factors , diabetes-related complications and therapeutic variables were all measured . RESULTS The two kinds of education showed no significant differences from each other . The two groups improved the level of knowledge ( P HbA1c ( P HDL-C ( P BMI ( P=0.001 ) and systolic pressure ( P=0.004 ) , and increased their use of reactive strips ( P=0.02 ) . CONCLUSIONS Health education on diabetes improved knowledge of the disease , metabolic control and cardiovascular risk factors . The two educational methods evaluated were equally effective",
"OBJECTIVE This study evaluated the efficacy of a nurse-care management system design ed to improve outcomes in patients with complicated diabetes . RESEARCH DESIGN AND METHODS In this r and omized controlled trial that took place at Kaiser Permanente Medical Center in Santa Clara , CA , 169 patients with longst and ing diabetes , one or more major medical comorbid conditions , and HbA(lc ) > 10 % received a special intervention ( n = 84 ) or usual medical care ( n = 85 ) for 1 year . Patients met with a nurse-care manager to establish individual outcome goals , attended group sessions once a week for up to 4 weeks , and received telephone calls to manage medications and self-care activities . HbA(lc ) , LDL , HDL , and total cholesterol , triglycerides , fasting glucose , systolic and diastolic blood pressure , BMI , and psychosocial factors were measured at baseline and 1 year later . Annualized physician visits were determined for the year before and during the study . RESULTS At 1 year , the mean reductions in HbA(lc ) , total cholesterol , and LDL cholesterol were significantly greater for the intervention group compared with the usual care group . Significantly more patients in the intervention group met the goals for HbA(1c ) ( psychosocial variables or in physician visits . CONCLUSIONS A nurse-care management program can significantly improve some medical outcomes in patients with complicated diabetes without increasing physician visits",
"BACKGROUND Diabetes mellitus ( DM ) group clinics can effectively control hypertension , but data to support glycemic control are equivocal . This study evaluated the comparative effectiveness of 2 DM group clinic interventions on glycosylated hemoglobin ( HbA(1c ) ) levels in primary care . METHODS Eighty-seven participants were recruited from a DM registry of a single regional Veterans Affairs medical center to participate in an open , r and omized comparative effectiveness study . Two primary care-based DM group interventions of 3 months ' duration were compared . Empowering Patients in Care ( EPIC ) was a clinician-led , patient-centered group clinic consisting of 4 sessions on setting self-management action plans ( diet , exercise , home monitoring , medications , etc ) and communicating about progress with action plans . The comparison intervention consisted of group education sessions with a DM educator and dietician followed by an additional visit with one 's primary care provider . Hemoglobin A(1c ) levels were compared after intervention and at the 1-year follow-up . RESULTS Participants in the EPIC intervention had significantly greater improvements in HbA(1c ) levels immediately following the active intervention ( 8.86%-8.04 % vs 8.74%-8.70 % of total hemoglobin ; mean [ SD ] between-group difference 0.67 % [ 1.3 % ] ; P=.03 ) , and these differences persisted at the 1 year follow-up ( 0.59 % [ 1.4 % ] , P=.05 ) . A repeated- measures analysis using all study time points found a significant time-by-treatment interaction effect on HbA(1c ) levels favoring the EPIC intervention ( F(2,85)=3.55 ; P=.03 ) . The effect of the time-by-treatment interaction seems to be partially mediated by DM self-efficacy ( F(1,85)=10.39 ; P=.002 ) . CONCLUSION Primary care-based DM group clinics that include structured goal - setting approaches to self-management can significantly improve HbA(1c ) levels after intervention and maintain improvements for 1 year . Trial Registration clinical trials.gov Identifier : NCT00481286",
"AIMS To estimate the efficacy of a self-monitoring-based disease management strategy in patients with Type 2 diabetes treated with oral agent monotherapy . METHODS This was an open-label , r and omized , pilot study , primarily led by diabetes nurses . Patients were r and omly allocated to either a self-monitoring-based disease management strategy or usual care ( ratio 3:1 ) and followed up for 6 months . Education was centred on how to modify lifestyle according self-monitoring readings . Self-monitoring of blood glucose results were discussed during monthly telephone contact . The primary endpoint was mean change in HbA(1c ) levels , estimated with an ANOVA for repeated measures . All analyses were intention to treat . RESULTS Three diabetic clinics recruited 62 patients , of whom five were lost to follow-up . At baseline , both groups had a mean HbA(1c ) value of 7.9 % ± 0.6 % ( 63 ± 6 mmol/mol ) . After 6 months , mean HbA(1c ) reduction was 1.2 ± 0.1 % ( -13 ± 1 mmol/mol ) in the intervention group and 0.7 ± 0.2 (-8 ± 2 mmol/mol ) in the control group , with an absolute mean difference between groups of -0.5 % ( 95 % CI -0.9 to -0.0 % ; P = 0.04 ) ( -5 mmol/mol , 95 % CI -10 to 0 ) . At study end , 61.9 % of patients in the intervention group and 20.0 % in the control group reached the target level of HbA(1c ) ( P = 0.005 ) . Body weight reduction was significantly greater in the intervention group than in the control group ( between-group absolute mean difference : -3.99 kg ; 95 % CI -7.26 to -0.73 ; P = 0.02 ) . Therapy changes were more frequent in the control group . CONCLUSIONS A self-monitoring disease management strategy , primarily led by diabetes nurses and allowing a timely and efficient use of self-monitoring readings , is able to improve metabolic control , primarily through lifestyle modifications leading to weight loss",
"Non-insulin-dependent diabetes mellitus ( NIDDM ) is preceded by impaired glucose tolerance ( IGT ) lasting for years before manifesting as overt hyperglycaemia . Both genetic and environmental factors contribute to the development of IGT and NIDDM . Obesity , physical inactivity and high-fat diet have been found to predict IGT and NIDDM . Therefore , a diet and exercise intervention from diagnosis of NIDDM could improve the treatment outcome and prognosis of patients with NIDDM . Furthermore , because subjects with IGT are at increased risk for diabetes and atherosclerotic vascular disease , it is reasonable to assume that in terms of reducing the incidence and longterm consequences of NIDDM an intervention at this phase is more effective than in overt diabetes . Although the nonpharmacological approach is generally accepted as the first-line treatment of NIDDM its efficacy has often been question ed . Therefore , it is important to carry out long-term controlled studies to find out to what extent lifestyle modification could improve the metabolic control and level of major cardiovascular risk factors known to be associated with poor outcome in NIDDM . This kind of study also gave relevant experience in planning studies aim ing at primary prevention of NIDDM . One-year dietary and exercise intervention on newly diagnosed NIDDM patients in Kuopio , Finl and result ed in a better metabolic control and a moderate reduction in cardiovascular risk factors as compared to the conventional treatment group . After the second year of follow-up only 12.5 % in the intervention group were receiving oral antidiabetic drugs vs. 34.8 % in the conventional treatment group . Weight reduction and a reduced use of saturated fats appeared to be the main determinants of successful treatment results . Good aerobic capacity was associated with an increase in HDL cholesterol . A multicentre primary prevention study on IGT patients is continuing in Finl and applying the same principles of intervention as used in the study on newly diagnosed NIDDM patients . Pilot results show that glucose tolerance can be improved by lifestyle changes",
"OBJECTIVE A trial was performed to establish whether our group care model for lifestyle intervention in type 2 diabetes can be exported to other clinics . RESEARCH DESIGN AND METHODS This study was a 4-year , two-armed , multicenter controlled trial in 13 hospital-based diabetes clinics in Italy ( current controlled trials no. IS RCT N19509463 ) . A total of 815 non – insulin-treated patients aged were r and omized to either group or individual care . RESULTS After 4 years , patients in group care had lower A1C , total cholesterol , LDL cholesterol , triglycerides , systolic and diastolic blood pressure , BMI , and serum creatinine and higher HDL cholesterol ( P prescriptions . Health behaviors , quality of life , and knowledge of diabetes had become better in group care patients than in control subjects ( P < 0.001 , for all ) . CONCLUSIONS The favorable clinical , cognitive , and psychological outcomes of group care can be reproduced in different clinical setting",
"BACKGROUND Glycemic goals ( hemoglobin A1c patients with type 2 diabetes despite the availability of many effective treatments and the documented benefits of glycemic control in the reduction of long-term microvascular and macrovascular complications . Several studies have established the important positive effects of pharmacist-led management on achieving glycemic control and other clinical outcomes in patients with diabetes . Diabetes prevalence and mortality are increasing rapidly in Jordan . Nevertheless , clinical pharmacists in Jordan do not typically provide pharmaceutical care ; instead , the principal responsibilities of pharmacists in Jordan are dispensing and marketing of medical products to physicians . OBJECTIVE To assess the primary clinical outcome of glycemic control ( A1c ) and secondary outcomes , including blood pressure , lipid values , self-reported medication adherence , and self-care activities for patients with type 2 diabetes in an outpatient diabetes clinic r and omly assigned to either usual care or a pharmacist-led pharmaceutical care intervention program . METHODS Patients with type 2 diabetes attending an outpatient diabetes clinic of a large teaching hospital were recruited over a 4-month period from January through April 2011 and r and omly assigned to intervention and usual care groups using the Minim software technique . The intervention group at baseline received face-to-face objective -directed education from a clinical pharmacist about type 2 diabetes , prescription medications , and necessary lifestyle changes , followed by 8 weekly telephone follow-up calls to discuss and review the prescribed treatment plan and to resolve any patient concerns . The primary outcome measure was glycemic control ( A1c ) , and secondary measures included systolic and diastolic blood pressure , complete lipid profile ( i.e. , total cholesterol , low-density lipoprotein cholesterol [ LDL-C ] , high-density lipoprotein cholesterol [ HDL-C ] , serum triglycerides ) , and self-reported medication adherence ( 4-item Morisky Scale ) and self-care activities ( Summary of Diabetes Self-Care Activities question naire ) . Data were collected at baseline and at 6 months follow-up . Changes from baseline to follow-up were calculated for biomarker values , and between-group differences in the change amounts were tested using the t test for independent sample s. A P value of usual care had baseline and 6-month follow-up values . Compared with baseline values , patients in the intervention group had a mean reduction of 0.8 % in A1c versus a mean increase of 0.1 % from baseline in the usual care group ( P = 0.019 ) . The intervention group compared with the usual care group had small but statistically significant improvements in the secondary measures of fasting blood glucose , systolic and diastolic blood pressure , total cholesterol , LDL-C , serum triglycerides , self-reported medication adherence , and self-care activities . Between-group differences in changes in the secondary measures of HDL-C and body mass index were not significant . CONCLUSIONS Patients with type 2 diabetes who received pharmacist-led pharmaceutical care in an outpatient diabetes clinic experienced reduction in A1c at 6 months compared with essentially no change in the usual care group . Six of 8 secondary biomarkers were improved in the intervention group compared with usual care",
"We examine whether one-to-one lifestyle counseling for non-insulin-treated diabetic out patients by a Certified Expert Nurse ( CEN ) can improve patients ' health outcomes . Participants were r and omly assigned to a 1-year lifestyle intervention ( n=67 ) or to a usual care group ( n=67 ) . Main outcome measures were changes from baseline in : HbA(1C ) and score of health related quality of life scales ( SF-36 and Problem Areas in Diabetes Scale ) . Cognitive/behavioral modification for 1 year and satisfaction in CEN counseling was also measured by self-produced items . We found no significant differences in HbA(1C ) , BMI , blood pressure , serum lipids , or health related quality of life over 1 year between the two groups . Patients in the intervention group , however , showed modest but more favorable modification of cognition ( p=0.004 ) and behavior ( p attrition rate ( 9 % ) , more frequent hospital visit ( 12+/-2 times versus 11+/-3 times ; p=0.03 ) and high degree of satisfaction ( 95 % ) in the intervention group indicate feasibility of the monthly CEN counseling in the outpatient setting s of Japanese hospitals . Future research should confirm the long-term effectiveness of the CEN counseling on clinical outcomes and the cost effectiveness of a possibly time-consuming intervention",
"BACKGROUND Adults with type 2 diabetes mellitus often have limitations in mobility that increase with age . An intensive lifestyle intervention that produces weight loss and improves fitness could slow the loss of mobility in such patients . METHODS We r and omly assigned 5145 overweight or obese adults between the ages of 45 and 74 years with type 2 diabetes to either an intensive lifestyle intervention or a diabetes support- and -education program ; 5016 participants contributed data . We used hidden Markov models to characterize disability states and mixed-effects ordinal logistic regression to estimate the probability of functional decline . The primary outcome was self-reported limitation in mobility , with annual assessment s for 4 years . RESULTS At year 4 , among 2514 adults in the lifestyle-intervention group , 517 ( 20.6 % ) had severe disability and 969 ( 38.5 % ) had good mobility ; the numbers among 2502 participants in the support group were 656 ( 26.2 % ) and 798 ( 31.9 % ) , respectively . The lifestyle-intervention group had a relative reduction of 48 % in the risk of loss of mobility , as compared with the support group ( odds ratio , 0.52 ; 95 % confidence interval , 0.44 to 0.63 ; P weight loss and improved fitness ( as assessed on treadmill testing ) were significant mediators of this effect ( P frequency of musculoskeletal symptoms at year 1 . CONCLUSIONS Weight loss and improved fitness slowed the decline in mobility in overweight adults with type 2 diabetes . ( Funded by the Department of Health and Human Services and others ; Clinical Trials.gov number , NCT00017953 . )",
"Objectives : Physical activity ( PA ) has the potential to improve outcomes in both arthritis and diabetes , but these conditions are rarely examined together . Our objective was to explore whether persons with arthritis alone or those with both arthritis and diabetes could improve amounts of PA with a home-based counselling intervention . Methods : As part of the Veterans LIFE ( Learning to Improve Fitness and Function in Elders ) Study , veterans aged 70–92 were r and omized to usual care or a 12-month PA counselling programme . Arthritis and diabetes were assessed by self-report . Mixed models were used to compare trajectories for minutes of endurance and strength training PA for persons with no arthritis ( n = 85 ) , arthritis ( n = 178 ) , and arthritis plus diabetes ( n = 84 ) . Results : Recipients of PA counselling increased minutes of PA per week independent of disease status ( treatment arm by time interaction p ; endurance training time p = 0.0006 and strength training time p Although PA was lower at each wave among persons with arthritis , and even more so among persons with arthritis plus diabetes , the presence of these conditions did not significantly influence response to the intervention ( arthritis/diabetes group × time interactions p > 0.05 for both outcomes ) as each group experienced a nearly twofold or greater increase in PA . Conclusions : A home-based PA intervention was effective in increasing minutes of weekly moderate intensity endurance and strength training PA in older veterans , even among those with arthritis or arthritis plus diabetes . This programme may serve as a useful model to improve outcomes in older persons with these pervasive diseases"
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Background The purpose of this systematic review was to examine the relationships between sedentary behaviour ( SB ) and health indicators in children aged 0 to 4 years , and to determine what doses of SB ( i.e. , duration , patterns [ frequency , interruptions ] , and type ) were associated with health indicators . Methods Online data bases were search ed for peer- review ed studies that met the a priori inclusion criteria : population ( apparently healthy , 1 month to 4.99 years ) , intervention/exposure and comparator ( duration s , patterns , and types of SB ) , and outcome /health indicator ( critical : adiposity , motor development , psychosocial health , cognitive development ; important : bone and skeletal health , cardiometabolic health , fitness , risks/harm ) . The quality of the evidence was assessed by study design and outcome using the Grading of Recommendations Assessment , Development and Evaluation ( GRADE ) framework . Results Due to heterogeneity , meta-analyses were not possible ; instead , narrative syntheses were conducted , structured around the health indicator and type of SB . A total of 96 studies were included ( 195,430 participants from 33 countries ) . Study design s were : r and omized controlled trial ( n = 1 ) , case-control ( n = 3 ) , longitudinal ( n = 25 ) , longitudinal with additional cross-sectional analyses ( n = 5 ) , and cross-sectional ( n = 62 ) . Evidence quality ranged from “ very low ” to “ moderate ” . Associations between objective ly measured total sedentary time and indicators of adiposity and motor development were predominantly None . Associations between screen time and indicators of adiposity , motor or cognitive development , and psychosocial health were primarily unfavourable or None . Associations between reading/storytelling and indicators of cognitive development were favourable or None . Associations between time spent seated ( e.g. , in car seats or strollers ) or in the supine position , and indicators of adiposity and motor development , were primarily unfavourable or None . Data were scarce for other outcomes . Conclusions These findings continue to support the importance of minimizing screen time for disease prevention and health promotion in the early years , but also highlight the potential cognitive benefits of interactive non-screen-based sedentary behaviours such as reading and storytelling . Additional high- quality research using valid and reliable measures is needed to more definitively establish the relationships between duration s , patterns , and types of SB and health indicators , and to provide insight into the appropriate dose of SB for optimal health in the early years | [
"OBJECTIVE To determine the television- , DVD- , and video-viewing habits of children younger than 2 years . DESIGN A telephone survey of 1009 parents of children aged 2 to 24 months . SETTING Parents in Minnesota and Washington state were surveyed . PARTICIPANTS A r and om sample of parents of children born in the previous 2 years was drawn from birth certificate records . Households in which English was not spoken were excluded , as were children with major disabilities . MAIN OUTCOME MEASURE The amount of regular television and DVD/video viewing by content , reasons for viewing , and frequency of parent-child coviewing . RESULTS By 3 months of age , about 40 % of children regularly watched television , DVDs , or videos . By 24 months , this proportion rose to 90 % . The median age at which regular media exposure was introduced was 9 months . Among those who watched , the average viewing time per day rose from 1 hour per day for children younger than 12 months to more than 1.5 hours per day by 24 months . Parents watched with their children more than half of the time . Parents gave education , entertainment , and babysitting as major reasons for media exposure in their children younger than 2 years . CONCLUSIONS Parents should be urged to make educated choices about their children 's media exposure . Parental hopes for the educational potential of television can be supported by encouraging those parents who are already allowing screen time to watch with their children",
"OBJECTIVE To test the hypothesis that audible television is associated with decreased parent and child interactions . DESIGN Prospect i ve , population -based observational study . SETTING Community . PARTICIPANTS Three hundred twenty-nine 2- to 48-month-old children . MAIN EXPOSURES Audible television . Children wore a digital recorder on r and om days for up to 24 months . A software program incorporating automatic speech- identification technology processed the recorded file to analyze the sounds the children were exposed to and the sounds they made . Conditional linear regression was used to determine the association between audible television and the outcomes of interest . OUTCOME MEASURES Adult word counts , child vocalizations , and child conversational turns . RESULTS Each hour of audible television was associated with significant reductions in age-adjusted z scores for child vocalizations ( linear regression coefficient , -0.26 ; 95 % confidence interval [ CI ] , -0.29 to -0.22 ) , vocalization duration ( linear regression coefficient , -0.24 ; 95 % CI , -0.27 to -0.20 ) , and conversational turns ( linear regression coefficient , -0.22 ; 95 % CI , -0.25 to -0.19 ) . There were also significant reductions in adult female ( linear regression coefficient , -636 ; 95 % CI , -812 to -460 ) and adult male ( linear regression coefficient , -134 ; 95 % CI , -263 to -5 ) word count . CONCLUSIONS Audible television is associated with decreased exposure to discernible human adult speech and decreased child vocalizations . These results may explain the association between infant television exposure and delayed language development",
"Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results",
"Objective : To examine risk factors for rapid weight gain between 3 and 5 years of age . Design : Nationally representative prospect i ve cohort study . Participants : A total of 11 653 preschool children participating in the UK Millennium Cohort Study , with anthropometry at 3 and 5 years . Measurements : Weight gain z-scores were calculated from 3 to 5 years . Children in the top quarter of this distribution were classified as gaining weight rapidly . A total of 26 biological and early life , social , psychological , behavioural and environmental risk factors were examined . Results : Among the participants , 13 % of normal weight , 63 % of overweight and 88 % of obese 5-year olds had experienced rapid weight gain since 3 years of age . Six biological and early life factors and two social factors were found to be significantly associated with this growth pattern . In a mutually adjusted model , children were more likely to gain weight rapidly if they had a higher body mass index at age 3 ( adjusted odds ratio : 1.27 , 95 % confidence interval : 1.23–1.32 ) , if they were of Bangladeshi ( adjusted odds ratio : 1.88 , 95 % confidence interval : 1.27–2.79 ) or black ( adjusted odds ratio : 1.47 , 95 % confidence interval : 1.07–2.02 ) ethnicity , if their mother was overweight ( adjusted odds ratio : 1.32 , 95 % confidence interval : 1.15–1.51 ) or had been overweight before pregnancy ( adjusted odds ratio : 1.56 , 95 % confidence interval : 1.36–1.79 ) , if their father was overweight ( adjusted odds ratio : 1.56 , 95 % confidence interval : 1.34–1.81 ) or if their mother smoked during pregnancy ( adjusted odds ratio:1.23 , 95 % confidence interval : 1.09–1.38 ) . Children were also more likely to gain weight rapidly if others smoked in the same room ( adjusted odds ratio : 1.31 , 95 % confidence interval : 1.16–1.49 ) or if they were a lone child in the household ( adjusted odds ratio : 1.14 , 95 % confidence interval : 1.01–1.30 ) . Conclusions : Factors operating during pregnancy and early life increase the risk of rapid weight gain in young children ; thus , signalling the importance of obesity prevention programmes before and during pregnancy and for children at an early age . In particular , these programmes should address parental weight status and smoking habits , both modifiable risk factors ",
"IMPORTANCE Identifying associations between preschool-aged children 's electronic media use and their later well-being is essential to supporting positive long-term outcomes . OBJECTIVE To investigate possible dose-response associations of young children 's electronic media use with their later well-being . DESIGN , SETTING , AND PARTICIPANTS The IDEFICS ( Identification and Prevention of Dietary- and Lifestyle-Induced Health Effects in Children and Infants ) study is a prospect i ve cohort study with an intervention component . Data were collected at baseline from September 1 , 2007 , through June 30 , 2008 , and at follow-up from September 1 , 2009 , through May 31 , 2010 , in 8 European countries participating in the IDEFICS study . This investigation is based on 3604 children aged 2 to 6 years who participated in the longitudinal component of the IDEFICS study only and not in the intervention . EXPOSURE Early childhood electronic media use . MAIN OUTCOMES AND MEASURES The following 6 indicators of well-being from 2 vali date d instruments were used as outcomes at follow-up : Peer problems and Emotional problems subscales from the Strengths and Difficulties Question naire and Emotional well-being , Self-esteem , Family functioning , and Social networks subscales from the KINDLR ( Question naire for Measuring Health-Related Quality of Life in Children and Adolescents-Revised Version ) . Each scale was dichotomized to identify those children at risk for poorer outcomes . Indicators of electronic media use ( weekday and weekend television and electronic game [e-game]/computer use ) from baseline were used as predictors . RESULTS Associations varied between boys and girls ; however , associations suggested that increased levels of electronic media use predicted poorer well-being outcomes . Television viewing on weekdays or weekends was more consistently associated with poorer outcomes than e-game/computer use . Across associations , the likelihood of adverse outcomes in children ranged from a 1.2- to 2.0-fold increase for emotional problems and poorer family functioning for each additional hour of television viewing or e-game/computer use depending on the outcome examined . CONCLUSIONS AND RELEVANCE Higher levels of early childhood electronic media use are associated with children being at risk for poorer outcomes with some indicators of well-being . Further research is required to identify potential mechanisms",
"Background / Objectives : This longitudinal study describes the relationship between young children ’s screen time , dietary habits and anthropometric measures . The hypothesis was that television viewing and other screen activities at baseline result in increased consumption of sugar-sweetened beverages ( SSB ) and increased BMI , BMI z-score and waist to height ratio ( WHtR ) two years later . A second hypothesis was that SSB consumption mediates the association between the screen activities and changes in the anthropometric measures .Subjects/ Methods : The study is a part of the prospect i ve cohort study IDEFICS ( “ Identification and prevention of dietary and lifestyle-induced health effects in children and infants ” ) , investigating diet , lifestyle and social determinants of obesity in 2 to 9-year-olds in eight European countries ( baseline n=16 225 , two-year follow-up ; n=11 038 ) . Anthropometry was objective ly measured , and behaviours were parent-reported . Results : The main hypothesis was supported , but the second hypothesis was not confirmed . The odds ratio of being in the highest quintile of % change in WHtR was 1.26 ( 95 % CI : 1.17–1.36 ) and in BMI 1.22 ( 95 % CI : 1.13–1.31 ) , for each hour per day watching television . The odds ratio of having increased SSB consumption was 1.19 ( 95 % CI : 1.09–1.29 ) for each hour per day watching TV . The associations for total screen time were slightly weaker . Conclusions : The results indicate substantial effects of TV viewing and other screen activities for young children , both on their consumption of sugary drinks and on an increase in BMI and central obesity . Our findings suggest that television viewing seems to have a stronger effect on food habits and anthropometry than other screen activities in this age group",
"Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more",
"Abstract Objective To identify risk factors in early life ( up to 3 years of age ) for obesity in children in the United Kingdom . Design Prospect i ve cohort study . Setting Avon longitudinal study of parents and children , United Kingdom . Participants 8234 children in cohort aged 7 years and a sub sample of 909 children ( children in focus ) with data on additional early growth related risk factors for obesity . Main outcome measures Obesity at age 7 years , defined as a body mass index 3 95th centile relative to reference data for the UK population in 1990 . Results Eight of 25 putative risk factors were associated with a risk of obesity in the final models : parental obesity ( both parents : adjusted odds ratio , 10.44 , 95 % confidence interval 5.11 to 21.32 ) , very early ( by 43 months ) body mass index or adiposity rebound ( 15.00 , 5.32 to 42.30 ) , more than eight hours spent watching television per week at age 3 years ( 1.55 , 1.13 to 2.12 ) , catch-up growth ( 2.60 , 1.09 to 6.16 ) , st and ard deviation score for weight at age 8 months ( 3.13 , 1.43 to 6.85 ) and 18 months ( 2.65 , 1.25 to 5.59 ) ; weight gain in first year ( 1.06 , 1.02 to 1.10 per 100 g increase ) ; birth weight , per 100 g ( 1.05 , 1.03 to 1.07 ) ; and short ( 10.5 hours ) sleep duration at age 3 years ( 1.45 , 1.10 to 1.89 ) . Conclusion Eight factors in early life are associated with an increased risk of obesity in childhood ",
"Background Previous research has suggested that television ( TV ) viewing may be associated with increased behavioral and emotional problems in children . However , there are few prospect i ve studies targeted for its association with outcomes of children under 3 years old . The purpose of this study was to exam the association between children ’s early TV exposure at ages 18 and 30 months and the behavioral and emotional outcomes at age 30 months . Methods We analyzed data collected prospect ively in the Japan Children ’s Study . TV exposure was assessed by mothers ’ report at infant ages of 18 and 30 months . The outcomes were assessed using the Strengths and Difficulties Question naire ( SDQ ) . Analysis of Covariance was used to estimate the effect of TV exposure on behavioral and emotional outcomes . Results The percentage of children who watched TV 4 hours or more per day was 29.4 % at age 18 months , 24.5 % at age 30 months , and 21 % at both ages . Hyperactivity – inattention at age 30 months was positively associated with TV exposure at age 18 months , whereas prosocial behavior was negatively associated with hours of exposure even after adjustment . However , there were no significant differences in SDQ subscales according to daily hours of TV viewing at age 30 months . Conclusions Daily TV exposure at age 18 months was associated with hyperactivity – inattention and prosocial behavior at age 30 months . However , the directly casual relation was not proved in the present study . Additional research considering the TV program content and exposure timing are needed to investigate the causal relation between TV viewing and behavioral outcome",
"OBJECTIVE . To examine the extent to which infant television viewing is associated with language and visual motor skills at 3 years of age . MEASURES . We studied 872 children who were participants in Project Viva , a prospect i ve cohort . The design used was a longitudinal survey , and the setting was a multisite group practice in Massachusetts . At 6 months , 1 year , and 2 years , mothers reported the number of hours their children watched television in a 24-hour period , from which we derived a weighted average of daily television viewing . We used multivariable regression analyses to predict the independent associations of television viewing between birth and 2 years with Peabody Picture Vocabulary Test III and Wide-Range Assessment of Visual Motor Abilities scores at 3 years of age . RESULTS . Mean daily television viewing in infancy ( birth to 2 years ) was 1.2 ( SD : 0.9 ) hours , less than has been found in other studies of this age group . Mean Peabody Picture Vocabulary Test III score at age 3 was 104.8 ( SD : 14.2 ) ; mean st and ardized total Wide-Range Assessment of Visual Motor Abilities score at age 3 was 102.6 ( SD : 11.2 ) . After adjusting for maternal age , income , education , Peabody Picture Vocabulary Test III score , marital status , and parity , and child 's age , gender , birth weight for gestational age , breastfeeding duration , race/ethnicity , primary language , and average daily sleep duration , we found that each additional hour of television viewing in infancy was not associated with Peabody Picture Vocabulary Test III or total st and ardized Wide-Range Assessment of Visual Motor Abilities scores at age 3 . CONCLUSION . Television viewing in infancy does not seem to be associated with language or visual motor skills at 3 years of age",
"Background Over the last decades , a decline in motor skills and in physical activity and an increase in obesity has been observed in children . However , there is a lack of data in young children . We tested if differences in motor skills and in physical activity according to weight or gender were already present in 2- to 4-year-old children . Methods Fifty-eight child care centers in the French part of Switzerl and were r and omly selected for the Youp'là bouge study . Motor skills were assessed by an obstacle course including 5 motor skills , derived from the Zurich Neuromotor Assessment test . Physical activity was measured with accelerometers ( GT1 M , Actigraph , Florida , USA ) using age-adapted cut-offs . Weight status was assessed using the International Obesity Task Force criteria ( healthy weight vs overweight ) for body mass index ( BMI ) . Results Of the 529 children ( 49 % girls , 3.4 ± 0.6 years , BMI 16.2 ± 1.2 kg/m2 ) , 13 % were overweight . There were no significant weight status-related differences in the single skills of the obstacle course , but there was a trend ( p = 0.059 ) for a lower performance of overweight children in the overall motor skills score . No significant weight status-related differences in child care-based physical activity were observed . No gender-related differences were found in the overall motor skills score , but boys performed better than girls in 2 of the 5 motor skills ( p ≤ 0.04 ) . Total physical activity as well as time spent in moderate-vigorous and in vigorous activity during child care were 12 - 25 % higher and sedentary activity 5 % lower in boys compared to girls ( all p in global motor skills . However , in accordance to data in older children , child care-based physical activity was higher in boys compared to girls . These results are important to consider when establishing physical activity recommendations or targeting health promotion interventions in young children",
"OBJECTIVE To estimate the influence of early childhood television exposure on fourth- grade academic , psychosocial , and lifestyle characteristics . DESIGN Prospect i ve longitudinal study . SETTING Institut de la Statistique du Québec , Québec , Canada . PARTICIPANTS A total of 1314 ( of 2120 ) children . Main Exposure Parent-reported data on weekly hours of television exposure at 29 and 53 months of age . We conducted a series of ordinary least-squares regressions in which children 's academic , psychosocial , and lifestyle characteristics are linearly regressed on early and preschool television exposure . OUTCOME MEASURES Parent and teacher reports of academic , psychosocial , and health behaviors and body mass index measurements ( calculated as weight in kilograms divided by height in meters squared ) at 10 years of age . RESULTS Adjusting for preexisting individual and family factors , every additional hour of television exposure at 29 months corresponded to 7 % and 6 % unit decreases in classroom engagement ( 95 % confidence interval [ CI ] , -0.02 to -0.004 ) and math achievement ( 95 % CI , -0.03 to 0.01 ) , respectively ; 10 % unit increases in victimization by classmates ( 95 % CI , 0.01 to 0.05 ) ; 13 % unit decreases in time spent doing weekend physical activity ( 95 % CI , 0.81 to 2.25 ) ; 9 % unit decreases in activities involving physical effort ( 95 % CI , -0.04 to 0.00 ) ; higher consumption scores for soft drinks and snacks by 9 % and 10 % ( 95 % CI , 0.00 to 0.04 and 95 % CI , 0.00 to 0.02 ) , respectively ; and 5 % unit increases in body mass index ( 95 % CI , 0.01 to 0.05 ) . Preschool increments in exposure also made a unique contribution to developmental risk . CONCLUSIONS The long-term risks associated with higher levels of early exposure may chart developmental pathways toward unhealthy dispositions in adolescence . A population -level underst and ing of such risks remains essential for promoting child development",
"INTRODUCTION Speech development in preschool children should be consistent with a child 's overall development . However , disorders of speech in childhood are not uncommon . OBJECTIVE The purpose of the study was to determine the impact of demographic and socio-economic conditions on the prevalence of speech disorders in preschool children in Bitola . METHODS The study is observational and prospect i ve with two years duration . During the period from May 2009 to June 2011 , 1607 children aged 3 and 5 years , who came for regular examinations , were observed . The following research methods were applied : pediatric examination , psychological testing ( Test of Chuturik ) , interviews with parents and a question naire for behavior of children ( Child Behavior Checklist - CBCL ) . RESULTS 1,607 children were analyzed , 772 aged three years , 835 aged five years , 51.65 % male and 49.35 % female . The prevalence of speech disorders was 37.65 % . Statistical analysis showed that these disorders were more frequent in three years old children , males living in rural areas and in larger families . They did not have their own rooms at home , they were using mobile phones and were spending many hours per day watching television , ( p significant speech disorders , ( p preschool children in Bitola have a high prevalence . Because of their influence on later cognitive development of children , the process requires cooperation among parents , children , speech and the audiologist with the significant role in prevention , early detection and treatment",
"Background : Using a large population -based sample , this study aims to verify whether televiewing at 29 mo , a common early childhood pastime , is prospect ively associated with school readiness at 65 mo . Methods : Participants are a prospect i ve longitudinal cohort of 991 girls and 1,006 boys from the Quebec Longitudinal Study of Child Development with parent-reported data on weekly hours of televiewing at 29 mo of age . We conducted a series of ordinary least-squares regressions in which children ’s scores on direct child assessment s of vocabulary , mathematical knowledge , and motor skills , as well as kindergarten teacher reports of socioemotional functioning , were linearly regressed on early televiewing . Results : Every SD increase ( 1.2 h ) in daily televiewing at 29 mo predicted decreases in receptive vocabulary , number knowledge scores , classroom engagement , and gross motor locomotion scores , as well as increases in the frequency of victimization by classmates . Conclusion : Increases in total time watching television at 29 mo were associated with subsequent decreases in vocabulary and math skills , classroom engagement ( which is largely determined by attention skills ) , victimization by classmates , and physical prowess at kindergarten . These prospect i ve associations , independent of key potential confounders , suggest the need for better parental awareness and compliance with existing viewing recommendations put forth by the American Academy of Pediatrics ( AAP )",
"OBJECTIVE : To prospect ively examine the relation between television watching and body fat change in children from preschool to early adolescence . METHODS : In a longitudinal study , 106 children were enrolled during preschool years ( mean age 4.0 y ) and followed into early adolescence ( mean age 11.1 y ) . Parents completed an annual question naire on the child 's television and video habits . Body mass index ( BMI ) , triceps skinfolds , and sum of five skinfolds were recorded yearly at annual clinic visits . Longitudinal statistical analyses were carried out using mixed modeling procedures to control for potential confounding by a number of factors . RESULTS : Television watching was an independent predictor of the change in the child 's BMI , triceps , and sum of five skinfolds throughout childhood . Its effect was only slightly attenuated by controlling for the baseline body fat , level of physical activity ( as measured repeatedly by Caltrac accelerometer ) , percent of calories from fat , total calorie intake , or the parents ' BMI or education . By age 11 , children who watched 3.0 h or more of television per day had a mean sum of skinfolds of 106.2 mm , compared with a mean sum of skinfolds of 76.5 mm for those who watched less than 1.75 h per day ( P=0.007 ) . Furthermore , the adverse effect of television viewing was worse for those children who were also sedentary or had a higher-fat diet . CONCLUSIONS : Children who watched the most television during childhood had the greatest increase in body fat over time . Healthy lifestyle education design ed to prevent obesity and its consequences should target television-watching habits of children",
"OBJECTIVE To report dietary intake and physical activity among preschool-aged children living in rural American Indian communities before participation in a family-based healthy lifestyle intervention and to compare data to current age-specific recommendations . SUBJECTS/ DESIGN One hundred thirty-five preschool-aged children , living in rural American Indian communities , provided diet and physical activity data before participating in a 2-year r and omized healthy lifestyle intervention . Three 24-hour dietary recalls assessed nutrient and food and added sugar intake , which were compared to the National Academy of Science 's Dietary Reference Intakes , the US Department of Agriculture 's MyPyramid , and American Heart Association recommendations . Time watching television and moderate plus vigorous activity was compared to MyPyramid and American Academy of Pediatrics recommendations . STATISTICAL ANALYSIS Nutrient , food group , added sugar intake , and time watching television and in moderate or vigorous activity were compared to recommendations by computing the percent of recommendations met . Nonparametric tests identified differences in diet and physical activity among age groups and normal and overweight children ( body mass index or = 85th percentile ) . RESULTS Average nutrient intakes met recommendations whereas food group intakes did not . Mean fruit and vegetable intakes for 2- to 3-year-olds were 0.36 c/day fruit and 0.45 c/day vegetables and , for 4- to 5-year-olds , 0.33 c/day fruit and 0.48 c/day vegetables . Both age groups reported consuming more than 50 g added sugar , exceeding the recommendation of 16 g. Overweight vs normal weight children reported significantly more sweetened beverage intake ( 8.0+/-0.10 vs 5.28+/-0.08 oz/day , P watching television 2.0 hours/day and significant differences were observed for total television viewing and nonviewing time between overweight and normal weight children ( 8.52+/-0.6 vs 6.54+/-0.6 hours/day , P 20 minutes/day of moderate or vigorous activity . CONCLUSIONS Overall , children in this sample did not meet MyPyramid recommendations for fruits or vegetables and exceed added sugar intake recommendations . Television viewing time and time when the television was on in the home was highly prevalent along with low levels of moderate or vigorous activity . The Healthy Children Strong Families intervention we studied has potential for improving nutrition and physical activity among preschool-aged children living in rural American Indian communities",
"Background : Using a birth cohort , this study aim ed to verify whether televiewing at 29 months , a common early childhood pastime , is prospect ively associated with self-reported victimization at age 12 . Methods : Participants are 991 girls and 1006 boys from the Quebec Longitudinal Study of Child Development . The main predictor comprised parent-reported daily televiewing by their children at 29 months . In the sixth grade , children reported how often they experienced victimization by classmates in the past year . The authors conducted multivariate linear regression , in which child self-reports of victimization were linearly regressed on early televiewing and potential confounders . Results : Every SD unit increase ( 0.88 hours ) in daily televiewing at 29 months predicted an 11 % SD unit increase in self-reported peer victimization by sixth grade classmates ( unst and ardized B = .031 , p Daily televiewing time at 29 months was associated with a subsequent increased risk of victimization by classmates at the end of sixth grade , a period which represents a critical developmental transition to middle school . Youth who experience peer victimization are at an increased risk of long-term mental health issues , such as depression , underachievement , and low self-esteem . This prospect i ve association , across a 10-year period , suggests the need for better parental awareness , acknowledgement , and compliance with existing recommendations put forth by the American Academy of Pediatrics",
"OBJECTIVE We sought to determine early life factors that predict body mass index ( BMI ) and overweight/obesity of children aged 2 years . METHODS A longitudinal and prospect i ve analysis was conducted with 330 first-time mothers and their newborns . Children 's weight and length were measured at 2 years . Main factors of interest included reported infant feeding practice s , children 's fruit/vegetable consumption , and television ( TV ) time . Maternal demographic data , weight and height , and smoking status were collected by face-to-face interview at baseline . Multiple linear and logistic regression models were run to determine factors that predicted BMI or overweight/obesity of children aged 2 years , respectively . RESULTS At age 2 years , 242 remained in the study ( retention rate 73 % ) . Mean ( SD ) BMI of children was 16.87 kg/m(2 ) ( 1.62 ) , with 14 % classified as overweight/obese . Factors predicting lower child BMI were longer breastfeeding duration , less TV viewing time , and lower child 's birth weight as well as maternal healthy prepregnancy weight status . Factors predicting children 's overweight/obesity status were shorter breastfeeding duration , earlier introduction of solid food , and maternal overweight or obesity . CONCLUSIONS At 2 years of age , longer breastfeeding duration was associated with lower BMI , while greater TV viewing time was associated with higher BMI , after adjusting for other factors . Early introduction of solids and maternal overweight or obesity were independently associated with overweight or obesity",
"OBJECTIVE To determine whether the amount , type , and patterns of television viewing predict the onset or the persistence of externalizing problems in preschool children . DESIGN Longitudinal study of a prospect i ve population -based cohort in the Netherl and s. SETTING Parents reported time of television exposure and type of programs watched by children . Externalizing problems were assessed using the Child Behavior Checklist at 18 and 36 months . PARTICIPANTS A population -based sample of 3913 children . MAIN EXPOSURE Television viewing time , content , and patterns of exposure ( at 24 and 36 months ) in children with and without preexisting problems to assess the incidence and persistence of externalizing problems . MAIN OUTCOME MEASURES Externalizing problems at 36 months . RESULTS Program content and time of television exposure assessed at 24 months did not predict the incidence of externalizing problems at 36 months ( odds ratio , 2.24 ; 95 % CI , 0.97 - 5.18 ) . However , the patterns of exposure over time reflecting high levels of television viewing were associated with the incidence of externalizing problems ( odds ratio , 2.00 ; 95 % CI , 1.07 - 3.75 ) and the persistence of the preexisting externalizing problems ( 2.59 ; 1.03 - 6.55 ) . CONCLUSIONS Our study showed that high television exposure increases the risk of the incidence and the persistence of externalizing problems in preschool children",
"Alarm about the increasing prevalence of childhood obesity has focussed attention on individual lifestyle behaviours that may contribute to unhealthy weight . More distal predictors such as maternal employment may also be implicated since working mothers have less time to supervise children 's daily activities . The research reported here used two waves of data from the Longitudinal Study of Australian Children to investigate whether mothers ' hours in paid work shape young children 's television viewing , snacking and physical activity , and through those lifestyle behaviours , children 's weight at ages 4 - 5 years and 6 - 7 years . At both ages , children 's lifestyle behaviours were interrelated and associated with weight status . Cross-sectional analysis confirmed small , direct associations between longer hours of maternal employment and child weight at age 4 - 5 years , but not with child 's weight measured two years later . In both the cross-sectional and prospect i ve analyses , the children of mothers who worked part-time watched less television and were less likely to be overweight than children of mothers who were not employed or who worked full-time . While associations were small , they remained significant after adjustment for maternal weight , household income and other factors . The combination of direct and indirect relationships between mothers ' work hours and the weight status of their young children provides additional support to calls for family-friendly work policies as an important means for promoting healthy family lifestyles and early childhood wellbeing",
"OBJECTIVE To assess the prevalence of overweight among Chinese preschool children and to explore risk factors of childhood obesity focusing on parental characteristics , feeding practice and lifestyle . METHODS Data on 930 families with 2- to 6-year-old children in five kindergartens were obtained in a cross sectional study . Families were r and omly selected from two of all six urban districts in Beijing , China . Information on parental characteristics , dietary habits , lifestyle habits , and feeding practice was collected by parental self-report question naires . The children 's stature and weight were measured in light clothing and without shoes . Overweight and obesity were defined according to international cut-off values , as proposed by the International Obesity Task Force . Multivariate regression analysis was used to explore risk factors of child overweight . RESULTS The overall prevalence of overweight and obesity was 10.7 % and 4.2 % , respectively , and increased with age . The prevalence of child overweight was 14.1 % and 7.5 % in obese and non-obese families , respectively . Significant associations were observed between child and parent characteristics for overweight , frequency of eating in restaurant , television hours , and hours of physical activity . Child overweight was associated with parental overweight ( Odds Ratio [ OR ] 2.43 , 95 % CI 0.78 , 6.59 ) , low maternal education level ( OR 2.22 , 95 % CI 1.39 , 3.55 ) , food restriction ( OR 2.68 , 95 % CI 1.64 , 4.29 ) , and television watching > 2h/d ( OR 1.56 , 95 % CI 1.17 , 2.09 ) , after adjusting for sex , age , family income and kindergarten ( for cluster study design ) . CONCLUSIONS Overweight prevalence among Chinese preschool children in Beijing is comparable to some European countries . Prevention strategies should include identified lifestyle risk factors",
"This article introduces the approach of GRADE to rating quality of evidence . GRADE specifies four categories-high , moderate , low , and very low-that are applied to a body of evidence , not to individual studies . In the context of a systematic review , quality reflects our confidence that the estimates of the effect are correct . In the context of recommendations , quality reflects our confidence that the effect estimates are adequate to support a particular recommendation . R and omized trials begin as high- quality evidence , observational studies as low quality . \" Quality \" as used in GRADE means more than risk of bias and so may also be compromised by imprecision , inconsistency , indirectness of study results , and publication bias . In addition , several factors can increase our confidence in an estimate of effect . GRADE provides a systematic approach for considering and reporting each of these factors . GRADE separates the process of assessing quality of evidence from the process of making recommendations . Judgments about the strength of a recommendation depend on more than just the quality of evidence",
"The main objective of this study was to test an explanatory model predicting preschool girls ' and boys ' body weight from certain child variables ( food intake , sedentary behaviors , and eating habits ) , as well as family variables ( interaction during mealtime and level of family financial re sources allocated to meeting children 's eating needs ) . A r and omized stratified sub sample of parents was selected from a larger study ( Quebec Longitudinal Study of Child Development , QLSCD-1998 - 2002 ) , with a breakdown of 581 girls and 611 boys of 4 years of age . Children 's skin fold ratio , weight , height , and Body Mass Index ( BMI ) were recorded . Question naires were administered to parents ( usually the mother ) . Using structural equation modeling ( SEM ) separately for girls and boys , the family environment model of healthy weight development was tested . Results yielded a good fit of the model for both genders . For boys , significant predictors of body weight in the model were family food insecurity and conflicts during mealtime . Healthy eating was predicted by food insecurity , mealtime conflicts , and sedentary behaviors . Mealtime conflicts predicted sedentary behaviors . For girls , none of the variables predicted body weight , however food insecurity predicted less healthy eating . These results outline the importance of prevention and intervention within families with young children",
"BACKGROUND . The American Academy of Pediatrics recommends children ≥2 years of age limit daily media exposure to ≤1 to 2 hours and not have a television set in children 's bedrooms . However , there are limited prospect i ve studies to address how timing of media exposure influences children 's health . OBJECTIVE . Our goal was to examine relations among children 's early , concurrent , and sustained television exposure and behavioral and social skills outcomes at 5.5 years . METHODS . We analyzed data collected prospect ively from the Healthy Steps for Young Children national evaluation . Television exposure was defined as > 2 hours of daily use ( at 30–33 months and 5.5 years ) and television in child 's bedroom ( at 5.5 years ) . At 5.5 years , outcomes were assessed by using the Child Behavior Checklist and social skills using the Social Skills Rating System . Linear regression was used to estimate the effect of television exposure on behavioral and social skills outcomes . RESULTS . Sixteen percent of parents reported that their child watched > 2 hours of television daily at 30 to 33 months only , 15 % reported > 2 hours of television daily at 5.5 years only , and 20 % reported > 2 hours of television daily at both times . Forty-one percent of the children had televisions in their bedrooms at 5.5 years . In adjusted analyses , sustained television viewing was associated with behavioral outcomes . Concurrent television exposure was associated with fewer social skills . For children with heavy television viewing only in early childhood , there was no consistent relation with behavioral or social skills outcomes . Having a television in the bedroom was associated with sleep problems and less emotional reactivity at 5.5 years but was not associated with social skills . CONCLUSIONS . Sustained exposure is a risk factor for behavioral problems , whereas early exposure that is subsequently reduced presents no additional risk . For social skills , concurrent exposure was more important than sustained or early exposure . Considering the timing of media exposure is vital for underst and ing the consequences of early experiences and informing prevention strategies",
"OBJECTIVE To examine associations of child television ( TV ) exposure and household TV use with aggressive behavior among 3-year-old children while controlling for demographic characteristics and risk and protective factors for aggression . DESIGN The Fragile Families and Child Wellbeing Study , a prospect i ve cohort study . SETTING Data collected at home and by telephone from parents of children born from 1998 to 2000 from 20 cities . PARTICIPANTS Mothers who completed a 36-month in-home survey and met inclusion criteria ( n = 3128 ) . MAIN EXPOSURE Direct child TV exposure and household TV use were the primary explanatory variables . Additional risk factors included neighborhood disorder and maternal factors like depression . OUTCOME MEASURES Childhood aggression was assessed with the Child Behavior Checklist/2 - 3 . Multivariate linear regression models were used to examine associations between TV measures , additional risk factors , and childhood aggression . RESULTS Children who were spanked in the past month ( beta = 1.24 , P depression ( beta = 0.92 , P parenting stress ( beta = 0.16 , P aggressive behavior . Direct child TV exposure ( beta = 0.16 , P household TV use ( beta = 0.09 , P childhood aggression , even when controlling for other factors . CONCLUSIONS Three-year-old children exposed to more TV , both directly and indirectly , are at increased risk for exhibiting aggressive behavior . Further research is essential to determine whether pediatric recommendations concerning TV and children should include limits for general household TV use",
"BACKGROUND Screen time , defined as time spent watching television , DVDs , or videos or playing computer or video games , has been related to serious health consequences in children , such as impaired language acquisition , violent behaviour , tobacco smoking and obesity . Our aim was to determine if a simple intervention aim ed at preschool-aged children , applied at the health maintenance visits , in the primary care setting , would be effective in reducing screen time . METHODS We used a two group r and omized controlled trial design . Two- to 6-year-old children and their parents were r and omly assigned to receive an intervention to reduce their screen time , BMI and parental report of aggressive behaviour . At the end of the intervention we made home visits at 2 , 6 and 9 months and the parents completed question naire . RESULTS Parents in the intervention group reported less screen time and less aggressive behaviour than those in the control group but there were no differences in BMI z scores . CONCLUSIONS This study shows that a preschool-based intervention can lead to reductions in young children 's television/video viewing"
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Background Physical activity reduces the risk of noncommunicable diseases and is therefore an essential component of a healthy lifestyle . Regular engagement in physical activity can produce immediate and long term health benefits . However , physical activity levels are not as high as might be expected . For example , according to the global World Health Organization ( WHO ) 2017 statistics , more than 80 % of the world ’s adolescents are insufficiently physically active . In response to this problem , physical activity programs have become popular , with step counts commonly used to measure program performance . Analysing step count data and the statistical modeling of this data is therefore important for evaluating individual and program performance . This study review s the statistical methods that are used to model and evaluate physical activity programs , using step counts . Methods Adhering to PRISMA guidelines , this review systematic ally search ed for relevant journal articles which were published between January 2000 and August 2017 in any of three data bases ( PubMed , PsycINFO and Web of Science ) . Only the journal articles which used a statistical model in analysing step counts for a healthy sample of participants , enrolled in an intervention involving physical exercise or a physical activity program , were included in this study . In these programs the activities considered were natural elements of everyday life rather than special activity interventions . Results This systematic review was able to identify 78 unique articles describing statistical models for analysing step counts obtained through physical activity programs . General linear models and generalized linear models were the most popular methods used followed by multilevel models , while structural equation modeling was only used for measuring the personal and psychological factors related to step counts . Surprisingly no use was made of time series analysis for analysing step count data . The review also suggested several strategies for the personalisation of physical activity programs . Conclusions Overall , it appears that the physical activity levels of people involved in such programs vary across individuals depending on psychosocial , demographic , weather and climatic factors . Statistical models can provide a better underst and ing of the impact of these factors , allowing for the provision of more personalised physical activity programs , which are expected to produce better immediate and long-term outcomes for participants . It is hoped that this review will identify the statistical methods which are most suitable for this purpose | [
"The aim of this study was to investigate the association between volume and frequency of moderate-intensity PA and step-based recommendations and individual body composition variables . Our cohort included 167 healthy ambulatory women ( mean age 62.8 ± 4.8 years ; body mass index [ BMI ] 27.3 ± 4.2 kg/m(2 ) ) who carried out daily activities while wearing the ActiGraph GT1 M accelerometer over a seven day period . Measurements of BMI , body fat mass index ( BFMI ) , fat-free mass index ( FFMI ) , waist-hip ratio ( WHR ) and visceral fat area ( VFA ) were obtained by the InBody 720 multifrequency bioelectrical impedance analysis ( MFBIA ) device . The significant relationship ( r(s)=0.66 ; p day . Moderate PA ( r(2)=0.03 - 0.06 ) and steps per day ( r(2)=0.05 - 0.20 ) were significantly associated with observed body composition parameters . Women spending > 300 min/week in moderate PA showed significantly lower values of BFMI ( p=0.02 ) than those who spent 150 - 300 min/week . Carrying out moderate PA for 30 min 5 days a week was significantly associated with lower BMI ( p=0.04 ; η(2)=0.02 ) , BFMI ( p=0.02 ; η(2)=0.03 ) and VFA ( p=0.03 ; η(2)=0.03 ) . In addition , higher amounts of daily steps were significantly associated with lower BMI ( p=0.00 ; η(2)=0.16 ) , BFMI ( p=0.00 ; η(2)=0.21 ) , VFA ( p=0.00 ; η(2)=0.20 ) and WHR ( p=0.00 ; η(2)=0.13 ) . A clear association was found between the generally recommended PA guidelines and body composition variables for the women examined in this study . However , the concept of 10,000 steps/day appears to be the strongest predictor of health-related body composition values",
"Background Recent systematic review s have suggested that pedometers may be effective motivational tools to promote walking . However , studies tend to be of a relatively short duration , with small clinical based sample s. Further research is required to demonstrate their effectiveness in adequately powered , community based studies . Objective Using a r and omized controlled trial design , this study assessed the impact of a 12-week graduated pedometer-based walking intervention on daily step-counts , self-reported physical activity and health outcomes in a Scottish community sample not meeting current physical activity recommendations . MethodS ixty-three women and 16 men ( 49.2 years ± 8.8 ) were r and omly assigned to either an intervention ( physical activity consultation and 12-week pedometer-based walking program ) or control ( no action ) group . Measures for step-counts , 7-day physical activity recall , affect , quality of life ( n = 79 ) , body mass , BMI , % body fat , waist and hip circumference ( n = 76 ) , systolic/diastolic blood pressure , total cholesterol and HDL cholesterol ( n = 66 ) were taken at baseline and week 12 . Analyses were performed on an intention to treat basis using 2-way mixed factorial analyses of variance for parametric data and Mann Whitney and Wilcoxon tests for non-parametric data . Results Significant increases were found in the intervention group for step-counts ( p time spent in leisure walking ( p = .02 ) and positive affect ( p = .027 ) . Significant decreases were found in this group for time spent in weekday ( p = .003 ) , weekend ( p = .001 ) and total sitting ( p = .001 ) with no corresponding changes in the control group . No significant changes in any other health outcomes were found in either group . In comparison with the control group at week 12 , the intervention group reported a significantly greater number of minutes spent in leisure time ( p = .008 ) , occupational ( p = .045 ) and total walking ( p = .03 ) , and significantly fewer minutes in time spent in weekend ( p = .003 ) and total sitting ( p = .022 ) . Conclusion A pedometer-based walking program , incorporating a physical activity consultation , is effective in promoting walking and improving positive affect over 12 weeks in community based individuals . The discussion examines possible explanations for the lack of significant changes in health outcomes . Continued follow-up of this study will examine adherence to the intervention and possible result ing effects on health outcomes",
"Background Pedometers provide a simple , cost effective means of motivating individuals to increase walking yet few studies have considered if short term changes in walking behaviour can be maintained in the long-term . The role of physical activity consultations in such interventions is unclear . The purpose of this study was to assess the sustainability of pedometer-based interventions and empirically examine the role of physical activity consultations using long-term results of a community-based walking study . Methods 79 low active Scottish men and women ( 63 women and 16 men ) from the Walking for Wellbeing in the West intervention study were r and omly assigned to receive either : Group 1 ; pedometer-based walking programme plus physical activity consultations or Group 2 ; pedometer-based walking programme and minimal advice . Step counts ( Omron HJ-109E Step-O-Meter pedometer ) , 7 day recall of physical activity ( IPAQ long ) , mood ( PANAS ) and quality of life ( EuroQol EQ-5D ) were assessed pre-intervention and 12 , 24 and 48 weeks after receiving the intervention . Body mass , body mass index and waist and hip circumference were assessed pre-intervention and 12 and 24 weeks after receiving the intervention . Analyses were performed on an intention to treat basis ( baseline value carried forward for missing data ) using mixed-factorial ANOVAs and follow-up t-tests . Results A significant main effect of time ( p step-counts attributable to significant increases in steps/day between : pre-intervention ( M = 6941 , SD = 3047 ) and 12 weeks ( M = 9327 , SD = 4136 ) , t(78 ) = - 6.52 , p variables of self-reported physical activity , mood and quality of life and are discussed . No other significant effects in health related outcomes were found . Conclusion Both interventions successfully increased and maintained step counts over 12 months . Physical activity consultations may encourage individuals to be active in other ways beyond walking and to reduce sitting time . Trial Registration NumberCurrent Controlled Trials Ltd IS RCT",
"Background Engaging in regular physical activity ( PA ) is critical for health , and adopting a consistent PA routine early in life is associated with greater PA over the lifespan . College women with weight concerns are at risk for weight gain , which may be prevented with regular PA . However , little is known about changes in PA engagement in this at-risk group . Purpose Using an outcome expectancy framework , this study used a prospect i ve longitudinal design to examine changes in PA during the first 2 years of college . We tested for concurrent and prospect i ve within-person relations between body satisfaction/perceived eating behavior and PA to determine when weight-concerned college women may increase or decrease PA . Methods Women who reported weight concerns at the start of college ( n = 294 ) completed five assessment s over 2 years , including measured weight , body/eating experiences , and 4 days of pedometer steps ( per assessment ) . Multilevel models addressed the result ing nested data structure ( days within assessment s within participants ) . Results Over 2 years , within-person change accounted for 65 % of PA variability ( ICC = 0.35 ) . PA was greatest at ( and subsequent to ) times when body satisfaction was lower , and when disinhibited eating and hedonic hunger were higher , than an individual ’s average ( ps college women show greater PA after negative eating and weight experiences . As these experiences change over time , health promotion efforts should help college women identify alternative , positive motivators for PA , which could facilitate consistent PA engagement",
"We investigated the relationship between walking levels and the local neighbourhood physical environment during the Walking for Wellbeing in the West ( WWW ) r and omised pedometer-based community intervention . Walking activity was recorded as step counts at baseline ( n = 76 ) , and at 3 months ( n = 57 ) , 6 months ( n = 54 ) , and 12 months ( n = 45 ) post-intervention . Objective physical environment data were obtained from GIS data sets and street surveys conducted using the SWAT audit tool . Sixty-nine environment variables were reduced to eight environment factors using principal axis factoring , and the relationship between environment factors and ( i ) step counts , and ( ii ) the change in step counts relative to baseline , was examined using hierarchical multiple linear regression , controlling for age , gender , income , and deprivation . Five environment factors were significant predictors of step counts , but none were significant predictors of the change in step counts relative to baseline . None of the demographic variables included in the analysis were significant predictors at any stage of the study . Total variance explained by the environment ranged from 6 % ( P walking levels during the WWW intervention , and to have contributed to the maintenance of walking levels post-intervention",
"Background Despite its health benefits , physical inactivity is pervasive , particularly among those living in lower-income urban communities . In such setting s , neighborhood safety may impact willingness to be regularly physically active . We examined the association of perceived neighborhood safety with pedometer-determined physical activity and physical activity self-efficacy . Methods and Findings Participants were 1,180 predominantly racial/ethnic minority adults recruited from 12 urban low-income housing complexes in metropolitan Boston . Participants completed a 5-d pedometer data - collection protocol and self-reported their perceptions of neighborhood safety and self-efficacy ( i.e. , confidence in the ability to be physically active ) . Gender-stratified bivariate and multivariable r and om effects models were estimated to account for within-site clustering . Most participants reported feeling safe during the day , while just over one-third ( 36 % ) felt safe at night . We found no association between daytime safety reports and physical activity among both men and women . There was also no association between night-time safety reports and physical activity among men ( p = 0.23 ) but women who reported feeling unsafe ( versus safe ) at night showed significantly fewer steps per day ( 4,302 versus 5,178 , p = 0.01 ) . Perceiving one 's neighborhood as unsafe during the day was associated with significantly lower odds of having high physical activity self-efficacy among both men ( OR 0.40 , p = 0.01 ) and women ( OR 0.68 , p = 0.02 ) . Conclusions Residing in a neighborhood that is perceived to be unsafe at night is a barrier to regular physical activity among individuals , especially women , living in urban low-income housing . Feeling unsafe may also diminish confidence in the ability to be more physically active . Both of these factors may limit the effectiveness of physical activity promotion strategies delivered in similar setting",
"A three-wave prospect i ve design was used to assess a model of motivation guided by self-determination theory ( Ryan & Deci , 2008 ) spanning the context s of school physical education ( PE ) and exercise . The outcome variables examined were health-related quality of life ( HRQoL ) , physical self-concept ( PSC ) , and 4 days of objective ly assessed estimates of activity . Secondary school students ( n = 494 ) completed question naires at three separate time points and were familiarized with how to use a sealed pedometer . Results of structural equation modeling supported a model in which perceptions of autonomy support from a PE teacher positively predicted PE-related need satisfaction ( autonomy , competence , and relatedness ) . Competence predicted PSC , whereas relatedness predicted HRQoL. Autonomy and competence positively predicted autonomous motivation toward PE , which in turn positively predicted autonomous motivation toward exercise ( i.e. , 4-day pedometer step count ) . Autonomous motivation toward exercise positively predicted step count , HRQoL , and PSC . Results of multi sample structural equation modeling supported gender invariance . Suggestions for future work are discussed",
"Background This study examines associations between pedometer-determined steps/day and parent-reported child 's Body Mass Index ( BMI ) and time typically spent watching television between school and dinner . Methods Young people ( aged 5 - 19 years ) were recruited through their parents by r and om digit dialling and mailed a data collection package . Information on height and weight and time spent watching television between school and dinner on a typical school day was collected from parents . In total , 5949 boys and 5709 girls reported daily steps . BMI was categorized as overweight or obese using Cole 's cut points . Participants wore pedometers for 7 days and logged daily steps . The odds of being overweight and obese by steps/day and parent-reported time spent television watching were estimated using logistic regression for complex sample s. Results Girls had a lower median steps/day ( 10682 versus 11059 for boys ) and also a narrower variation in steps/day ( interquartile range , 4410 versus 5309 for boys ) . 11 % of children aged 5 - 19 years were classified as obese ; 17 % of boys and girls were overweight . Both boys and girls watched , on average , television between school and dinner on school days . Adjusting for child 's age and sex and parental education , the odds of a child being obese decreased by 20 % for every extra 3000 steps/day and increased by 21 % for every 30 minutes of television watching . There was no association of being overweight with steps/day , however the odds of being overweight increased by 8 % for every 30 minutes of additional time spent watching television between school and dinner on a typical school day . Discussion Television viewing is the more prominent factor in terms of predicting overweight , and it contributes to obesity , but steps/day attenuates the association between television viewing and obesity , and therefore can be considered protective against obesity . In addition to replacing opportunities for active alternative behaviours , exposure to television might also impact body weight by promoting excess energy intake . Conclusions In this large nationally representative sample , pedometer-determined steps/day was associated with reduced odds of being obese ( but not overweight ) whereas each parent-reported hour spent watching television between school and dinner increased the odds of both overweight and obesity",
"Purpose : To ( 1 ) compare the effects of two worksite-based walking interventions on employee participation rates ; ( 2 ) compare average daily step counts between conditions , and ; ( 3 ) examine the effects of increases in average daily step counts on biometric and psychologic outcomes . Design : We conducted a cluster-r and omized trial in which six employer groups were r and omly selected and r and omly assigned to condition . Setting : Four manufacturing worksites and two office-based worksite served as the setting . Subjects : A total of 474 employees from six employer groups were included . Intervention : A st and ard walking program was compared to an enhanced program that included incentives , feedback , competitive challenges , and monthly wellness workshops . Measures : Walking was measured by self-reported daily step counts . Survey measures and biometric screenings were administered at baseline and 3 , 6 , and 9 months after baseline . Analysis : Analysis used linear mixed models with repeated measures . Results : During 9 months , participants in the enhanced condition averaged 726 more steps per day compared with those in the st and ard condition ( p in average daily steps was associated with significant weight loss for both men ( −3.8 lbs . ) and women ( −2.1 lbs . ) , and reductions in body mass index ( −0.41 men , −0.31 women ) . Higher step counts were also associated with improvements in mood , having more energy , and higher ratings of overall health . Conclusions : An enhanced walking program significantly increases participation rates and daily step counts , which were associated with weight loss and reductions in body mass index ",
"Background This study focuses on the comparison of weekday/weekend parent-child behavioural patterns ( step count ( SC ) and screen time ( ST ) ) and answers the question of whether achieving the recommendations for daily SC ( 10,000 ) in parents also helps their preschool children achieve the recommended daily SC ( 11,500 ) . Methods The participants ( 278 parents aged 30–45 and their 194 children aged 4–7 ) were r and omly recruited from 10 Czech public kindergartens . The participants recorded SC ( pedometer Yamax Digiwalker SW-200 ) and ST duration ( proxy-report ) for seven consecutive days ( ≥8 h/day ) during September – October 2014 and April – May 2015 . Differences between weekdays/weekends SC or ST were tested using a paired t-test . The odds of achieving the recommended daily SC for children were estimated using general logistic regression separately for weekdays and weekends . Results Only the mothers were found to have a significantly lower SC at weekends than on weekdays . All of the participants showed significantly more ST at weekends than on weekdays ( daughters : 78.6 vs. 45.7 min/day , p achieve daily SC recommendation if a ) the SC on weekdays during the daily routine in kindergarten exceeded the median of kindergarten SC or b ) at weekends if their mother ( OR : 9.67 , 95 % CI : 3.57–26.23 ) exceeded 10,000 steps a day . Conclusions Especially at weekends , preschoolers have higher odds of meeting the recommended 11,500 steps per day when their mother reaches 10,000 steps per day and this is independent of the amount of parents ’ ST . Moreover , physical activity in kindergarten helps preschool children meet the 11,500 recommended steps per day on weekdays . Therefore , interventions to promote physical activity in preschoolers should focus on kindergartens and encourage involvement of their families",
"Background Interventions design ed to increase workplace physical activity may not automatically reduce high volumes of sitting , a behaviour independently linked to chronic diseases such as obesity and type II diabetes . This study compared the impact two different walking strategies had on step counts and reported sitting times . Methods Participants were white-collar university employees ( n = 179 ; age 41.3 ± 10.1 years ; 141 women ) , who volunteered and undertook a st and ardised ten-week intervention at three sites . Pre-intervention step counts ( Yamax SW-200 ) and self-reported sitting times were measured over five consecutive workdays . Using pre-intervention step counts , employees at each site were r and omly allocated to a control group ( n = 60 ; maintain normal behaviour ) , a route-based walking group ( n = 60 ; at least 10 minutes sustained walking each workday ) or an incidental walking group ( n = 59 ; walking in workday tasks ) . Workday step counts and reported sitting times were re-assessed at the beginning , mid- and endpoint of intervention and group mean± SD steps/day and reported sitting times for pre-intervention and intervention measurement points compared using a mixed factorial ANOVA ; paired sample -t-tests were used for follow-up , simple effect analyses . Results A significant interactive effect ( F = 3.5 ; p counts . Daily steps for controls decreased over the intervention period ( -391 steps/day ) and increased for route ( 968 steps/day ; t = 3.9 , p for reported sitting times , but average values did decrease relative to the control ( routes group = 7 minutes/day ; incidental group = 15 minutes/day ) . Reductions were most evident for the incidental group in the first week of intervention , where reported sitting decreased by an average of 21 minutes/day ( t = 1.9 ; p increased physical activity in white-collar employees . Our data suggests that workplace walking , particularly through incidental movement , also has the potential to decrease employee sitting times , but there is a need for on-going research using concurrent and objective measures of sitting , st and ing and walking",
"Objective : Confirmation and quantification of observed differences in goal -directed walking behavior . Design : Single-blind , split-half r and omized trial . Setting : Small rural university , Pennsylvania , United States . Subjects : A total of 94 able-bodied subjects ( self-selected volunteer students , faculty and staff of a small university ) were r and omly assigned walking goals , and 53 completed the study . Interventions : Incentivized pedometer-monitored program requiring recording the step-count for 56-days into a custom-made website providing daily feedback . Main outcome measures : Steps logged per day . Results : During the first half of the study , the 5000 and 10,000 step group logged significantly different steps 7500 and 9000 , respectively ( P > 0.05 ) . During the second half of the study , the 5000 and 10,000 step groups logged 7000 and 8600 steps , respectively ( significance P > 0.05 ) . The group switched from 5000 to →10,000 steps logged , 7900 steps for the first half and 9500 steps for the second half ( significance P > 0.05 ) . The group switched from 10,000 to 5000 steps logged 9700 steps for the first half and 9000 steps for the second half , which was significant ( p > 0.05 ) . Conclusions : Levels of walking behavior are influenced by the goals assigned . Subjects with high goals walk more than those with low goals , even if they do not meet the assigned goal . Reducing goals from a high to low level can reduce walking behavior ",
"OBJECTIVES Given the importance of optimizing physical activity in adolescents , the purpose of this study was to examine the effect of activity mode , environment , and semester on step counts/minute and MVPA during daily middle-school physical education ( PE ) . DESIGN A prospect i ve and observational research design . METHODS Participants included 232 students ( Mean age=13.3±0.4 years ) recruited from the seventh and eighth grade s from one public middle-school in the U.S. Activity modes were employed across the school year including motor skills , games , and fitness activities located in indoor and outdoor environments . Step counts/minute and MVPA were monitored across 132 PE lessons during Fall and Spring semesters using NL-1000 piezoelectric pedometers . A three-way Multivariate Analysis of Covariance ( MANCOVA ) was employed to examine the effect of activity mode ( skill games vs. fitness ) , environment ( indoors vs. outdoors ) , and semester ( Fall vs. Spring ) on student step counts/minute and MVPA . MANCOVA was followed by separate ANCOVA tests . RESULTS MANCOVA yielded a statistically significant three-way interaction ( Wilks ' Λ=0.98 F(2 , 1153)=8.9 , P that physical activity was higher during outdoor fitness activities in the Fall compared to indoor motor skills in the Spring for step counts/minute ( Mean difference=27.0 steps/minute , P ) and MVPA ( Mean difference=7.8min , P indoor motor skill games in the Spring",
"OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity",
"PURPOSE The objective of this study was to evaluate the impact of a school-based intervention ( Program X ) incorporating pedometers and e-mail support on physical activity , sedentary behavior , and healthy eating in adolescents . METHODS A r and omized control trial was used to evaluate the impact of the Program X intervention . Six schools ( N = 124 participants ; mean age 14.1 + /- .8 years ) were r and omized to intervention or control conditions for the 6-month study period . Objective ly recorded physical activity ( mean steps/day ) , self-reported sedentary behavior , and dietary habits were measured at baseline and at 6-month follow-up and intervention effects were assessed using repeated- measures analysis of variance and chi(2 ) tests . RESULTS Participants in the intervention group increased their step counts by 956 + /- 4107 steps/day ( boys ) and 999 + /- 1999 ( girls ) . Repeated- measures analysis of variance revealed significant group-by-time interactions for boys ( F = 7.4 , p = .01 , d = .80 ) and girls ( F = 29.6 , p number of energy-dense/low-nutrient snacks consumed by boys ( chi(2 ) = 4.0 , p = .043 ) and increased the number of fruit serves among girls ( chi(2 ) = 4.8 , p = .028 ) . The intervention did not have a statistically significant effect on sedentary behavior . CONCLUSION A school-based intervention incorporating physical activity monitoring using pedometers and e-mail support was successful in promoting physical activity and selected healthy eating behaviors in adolescent boys and girls",
"Aims : To examine the development in pedometer-determined physical activity from 2007–2008 to 2011–2012 in the adult Danish population . Methods : The study population comprised two r and om sample s of 18–75-year-old individuals who took part in cross-sectional studies in 2007–2008 ( n=224 ) and 2011–2012 ( n=1515 ) . Pedometer data ( sealed Yamax SW 200 ) were obtained for seven consecutive days . Data for 1624 participants ( 48.2 % men ) were included in the analysis . An overall step-defined activity level was examined based on a graduated step index ( sedentary , low active , somewhat active , active , highly active ) . The pedometer-determined outcomes were analysed using regression models . Results : A borderline significant decline ( p=0.077 ) from 8788 to 8341 steps/day ( −446 ( 95 % confidence intervals −50 , 943 ) ) was found between 2007–2008 and 2011–2012 . Furthermore , a 23.7 % ( 95 % confidence intervals −41.7 % , −0.1 % ) lower overall step-defined activity level was observed in 2011–2012 compared to 2007–2008 . These changes were primarily due to a reduced level of activity among women . The proportion of individuals taking ⩾10,000 steps/day decreased non-significantly from 34.8 % to 29.3 % , whereas the proportion taking the physical activity level among Danish adults . The reduction was due to a shift in the population distribution from higher to lower levels of activity . If this shift is true , it is worrying from a public health perspective . Our study result needs , however , to be confirmed by other population studies",
"OBJECTIVE To assess whether the \" 10,000 Steps Ghent \" intervention had any effect on self-reported sitting time . METHODS A multi- strategy community-based intervention was implemented in 2005 to promote physical activity ( PA ) to adults living in Ghent , Belgium . In 2005 , 648 r and omly selected participants ( aged 25 to 75 ) from the intervention community Ghent and 592 from a comparison community , completed the International Physical Activity Question naire ( IPAQ ) and a pedometer log . Of these , 440 intervention participants and 426 comparison participants completed the follow-up measurements in 2006 . RESULTS A decrease of 12 min in total daily sitting time was found in the intervention community , compared with an increase of 18 min/day in the comparison community ( F=9.5 , p=0.002 ) . The effect was seen for both weekday ( p=0.044 ) and weekend day ( p sitting times . In the intervention community , total daily sitting time decreased more in the participants who increased their step counts ( -18 min/day ; t=2.5 ; p=0.012 ) , than in those who did not ( no change ; t=0.8 , ns ) . CONCLUSIONS After 1 year of intervention , total , weekday , and weekend day sitting times were reduced in the intervention community , while sitting time increased in the comparison community",
"Background Following publication of the PRISMA statement , the UK Centre for Review s and Dissemination ( CRD ) at the University of York in Engl and began to develop an international prospect i ve register of systematic review s with health-related outcomes . The objectives were to reduce unplanned duplication of review s and provide transparency in the review process , with the aim of minimizing reporting bias . Methods An international advisory group was formed and a consultation undertaken to establish the key items necessary for inclusion in the register and to gather views on various aspects of functionality . This article describes the development of the register , now called PROSPERO , and the process of registration . Results PROSPERO offers free registration and free public access to a unique prospect i ve register of systematic review s across all areas of health from all around the world . The dedicated web-based interface is electronically search able and available to all prospect i ve registrants . At the moment , inclusion in PROSPERO is restricted to systematic review s of the effects of interventions and strategies to prevent , diagnose , treat , and monitor health conditions , for which there is a health-related outcome .Ideally , registration should take place before the research ers have started formal screening against inclusion criteria but review s are eligible as long as they have not progressed beyond the point of completing data extraction .The required data set captures the key attributes of review design as well as the administrative details necessary for registration .Su bmi tted registration forms are checked against the scope for inclusion in PROSPERO and for clarity of content before being made publicly available on the register , rejected , or returned to the applicant for clarification . The public records include an audit trail of major changes to planned methods , details of when the review has been completed , and links to result ing publications when provided by the authors . Conclusions There has been international support and an enthusiastic response to the principle of prospect i ve registration of protocol s for systematic review s and to the development of PROSPERO .In October 2011 , PROSPERO contained 200 records of systematic review s being undertaken in 26 countries around the world on a diverse range of interventions",
"OBJECTIVE Using a r and omised control trial design , this study assessed the impact of two walking interventions , on the work day step counts and health of UK academic and administrative , university employees . METHOD A convenience sample of 58 women ( age 42+/-10 years ) and 6 men ( age 40+/-11 years ) completed baseline and intervention measures for step counts , % body fat , waist circumference and systolic/diastolic blood pressure , during a ten-week period ( October to December , 2005 ) . Before intervention , baseline step counts ( five working days ) were used to r and omly allocate participants to a control ( maintain normal behaviour , n=22 ) and two treatment groups ( \" walking routes \" , n=21 ; \" walking in tasks \" , n=21 ) . Intervention effects were evaluated by calculating differences between pre-intervention and intervention data . A one-way ANOVA analysed significant differences between groups . RESULTS A significant intervention effect ( p step counts , with mean differences indicating a decrease in steps for the control group ( -767 steps/day ) and increases in the \" walking routes \" ( + 926 steps/day ) and \" walking in tasks \" ( + 997 steps/day ) groups . Small , non-significant changes were found in % body fat , waist circumference and blood pressure . CONCLUSIONS Findings have implication s for work-based physical activity promotion and the development of walking interventions within the completion of work-based tasks",
"Background Physical activity ( PA ) is important for controlling childhood obesity , but a comprehensive PA model for school-aged children is lacking . Objectives Guided by the youth PA promotion ( YPAP ) model , this study estimated the direct and indirect effects of self-efficacy , enjoyment , parental influence , and environment on self-reported PA and pedometer steps . A secondary purpose was to explore the association between self-reported PA and pedometer steps . Methods An observational and prospect i ve study was conducted among 133 children , aged 8–11 years old , from 10 elementary schools with afterschool programs in a Midwestern U.S. school district from August through October 2013 . PA was assessed by a 7-day recall scale and pedometers . Other variables were assessed by vali date d question naires . Results Approximately 65 ( 49 % ) children were overweight or obese — only 17 ( 13 % ) met national PA recommendations — and body mass index z-score was negatively correlated with pedometer steps ( r = −.18 p = .04 ) . A path analysis showed that self-efficacy had a direct effect on self-reported PA and pedometer steps , enjoyment had only a direct effect on self-reported PA , and parental influence had a direct effect on pedometer steps and an indirect effect on self-reported PA through self-efficacy and enjoyment . The association between self-reported PA and pedometer steps was not significant . Discussion Because this study only partially supports the YPAP model , studies with a larger sample size and longitudinal design are essential to further examine this model . The nonsignificant relationship of self-reported PA with pedometer steps may be due to the systematic error result ing from a common method artifact of self-report . Given the importance of parental influence , enjoyment , and self-efficacy , targeting these three determinants in future interventions to increase PA among children is recommended",
"Little is known about the effectiveness of school-based health promotion on physical activity inequalities among children from low-income areas . This study compared the two-year change in physical activity among 10 - 11 year-old children attending schools with and without health promotion programs by activity level , body weight status , and socioeconomic background s to assess whether health promotion programs reduce or exacerbate health inequalities . This was a quasi-experimental trial of a Comprehensive School Health ( CSH ) program implemented in schools located in socioeconomically disadvantaged neighbourhoods in Edmonton , Alberta , Canada . In the spring of 2009 and 2011 , pedometer ( 7 full days ) and demographic data were collected from cross-sectional sample s of grade five children from 10 intervention and 20 comparison schools . Socioeconomic status was determined from parent self-report . Low-active , active , and high-active children were defined according to step-count tertiles . Multilevel linear regression methods adjusted for potential confounders were used to assess the relative inequity in physical activity and were compared between groups and over-time . In 2009 , a greater proportion of students in the intervention schools were overweight ( 38 % vs. 31 % p = 0.03 ) and were less active ( 10,827 vs. 12,265 steps/day p relative difference in step-counts between intervention and comparison schools reduced from -15.5 % to 0 % among low-active students , from -13.4 % to 0 % among active students , and from -15.1 % to -2.7 % among high-active students . The relative difference between intervention and comparison schools reduced from -11.1 % to -1.6 % among normal weight students , from -16.8 % to -1.4 % among overweight students , and was balanced across socioeconomic subgroups . These findings demonstrate that CSH programs implemented in socioeconomically disadvantaged neighbourhoods reduced inequalities in physical activity . Investments in school-based health promotion are a viable , promising , and important approach to improve physical activity and prevent childhood obesity , and may also reduce inequalities in health",
"OBJECTIVE To investigate the suitability of N-of-1 r and omized controlled trials ( RCTs ) as a means of testing the effectiveness of behavior change techniques based on self-regulation theory ( goal setting and self-monitoring ) for promoting walking in healthy adult volunteers . METHOD A series of N-of-1 RCTs in 10 normal and overweight adults ages 19 - 67 ( M = 36.9 years ) . We r and omly allocated 60 days within each individual to text message-prompted daily goal - setting and /or self-monitoring interventions in accordance with a 2 ( step-count goal prompt vs. alternative goal prompt ) × 2 ( self-monitoring : open vs. blinded Omron-HJ-113-E pedometer ) factorial design . Aggregated data were analyzed using r and om intercept multilevel models . Single cases were analyzed individually . The primary outcome was daily pedometer step counts over 60 days . RESULTS Single-case analyses showed that 4 participants significantly increased walking : 2 on self-monitoring days and 2 on goal - setting days , compared with control days . Six participants did not benefit from the interventions . In aggregated analyses , mean step counts were higher on goal - setting days ( 8,499.9 vs. 7,956.3 ) and on self-monitoring days ( 8,630.3 vs. 7,825.9 ) . Multilevel analyses showed a significant effect of the self-monitoring condition ( p = .01 ) , the goal - setting condition approached significance ( p = .08 ) , and there was a small linear increase in walking over time ( p = .03 ) . CONCLUSION N-of-1 r and omized trials are a suitable means to test behavioral interventions in individual participants",
"OBJECTIVE Although several studies have examined the effect of accumulated bouts on health outcomes , the impact of recommending short bouts on activity-related behavior in health promotion efforts has received minimal investigation . METHOD During this 5-week study in 2007 - 2008 , 43 university employees ( 8 male , 35 female ) in the Southeastern United States were r and omly assigned to a group recommended to achieve ( a ) 10,000 steps ( 10 K ) , ( b ) 30-minutes ( 30 min ) of continuous physical activity , or ( c ) 30-minutes of activity in bouts of at least 10 minutes ( bouts ) . RESULTS AND CONCLUSIONS Repeated measures ANOVA revealed that the 10 K group showed the largest increase in step counts whereas the bouts group showed the smallest change over the intervention period , p=0.01 . Condition differences were most pronounced on days in which participants met their activity recommendation . Accelerometer results revealed that the 10 K ( d=1.1 ) and 30 min groups ( d=0.89 ) showed large increases in minutes of moderate to vigorous activity ( MVPA ) , whereas the bouts group showed minimal change ( d=0.11 ) . Although activity recommendations did not differentially affect self-efficacy , participants from all conditions showed decreased self-efficacy across the intervention ( p=0.02 ) , highlighting the need to develop strategies to increase self-efficacy in activity promotion efforts",
"Using a r and omised controlled trial design , this feasibility study assessed the impact of two walking interventions on quality of life ( QoL ) and job performance of Catalan university employees . A convenience sample of 70 employees completed baseline and intervention measures of step counts ( Yamax SW 200 pedometer ) , wellbeing ( SF-12 question naire ) and work performance ( Work Limitations Question naire ) over 9 weeks . Before intervention , baseline step counts ( five working days ) were used to r and omly allocate participants to a control ( n = 26 ) , “ walking routes ” ( n = 19 ) and “ walking while working ” ( n = 25 ) groups . Intervention effects were evaluated by calculating differences between pre-intervention and intervention data . One-way ANOVA was used to examine differences between groups . No significant group differences were found for changes in work-day step counts , QoL or work performance . When data from the two intervention groups were pooled ( n = 44 ) there was a significant increase in step counts ( + 659 steps/day ; n = 12 ; p 10,000 steps/day ; n = 21 ) and no change in those categorised as ` Moderately Active ' ( 7500—9999 , n = 11 ) . The ` Sedentary — Low activity ' group showed consistently greater improvements in QoL and work performance scores than the Moderate and Active groups . Initially low active participants showed the greatest increase in step counts and improved QoL and work productivity profiles . These data indicate the potential for improving QoL and job productivity through workplace walking in inactive Catalan employees",
"BACKGROUND Urban elementary schools in minority communities with high obesity prevalence may have limited re sources for physical education ( PE ) to achieve daily activity recommendations . Little is known whether integrating physical activity ( PA ) into classrooms can increase activity levels of students attending such schools . METHODS We conducted a cluster r and omized , controlled trial among kindergarten and first- grade students from four Bronx , New York , schools to determine feasibility and impact of a classroom-based intervention on students ' PA levels . Students in two intervention schools received the Children 's Hospital at Montefiore Joining Academics and Movement ( CHAM JAM ) , an audio CD consisting of 10-minute , education-focused aerobic activities led by teachers three times a day . PA was objective ly measured by pedometer . Each subject wore a sealed pedometer during the 6-hour school day for 5 consecutive days at baseline ( Time 1 ) and 8 weeks postintervention ( Time 2 ) . Hierarchical linear models were fit to evaluate differences in mean number of steps between the two groups . RESULTS A total of 988 students participated ( intervention group , n=500 ; control group , n=488 ) . There was no significant difference at baseline between the two groups on mean number of steps ( 2581 [ st and ard deviation ( SD ) , 1284 ] vs. 2476 [ SD , 1180 ] ; P=0.71 ) . Eight weeks post-CHAM JAM , intervention group students took significantly greater mean number of steps than controls ( 2839 [ SD , 1262 ] vs. 2545 [ SD , 1153 ] ; P=0.0048 ) after adjusting for baseline number of steps and other covariates ( grade , gender , recess , and PE class ) . CHAM JAM was equally effective in gender , grade level , and BMI subgroups . CONCLUSIONS CHAM JAM significantly increased school-based PA among kindergarten and first- grade students in inner-city schools . This approach holds promise as a cost-effective means to integrate the physical and cognitive benefits of PA into high-risk schools",
"BACKGROUND Although previous studies have reported physical activity and its sociodemographic determinants using self-report measures , there have been few studies using pedometers . PURPOSE To ascertain pedometer-determined physical activity and its sociodemographic determinants among community residents living in four Japanese cities . METHODS A cross-sectional mail survey was conducted from February 2007 to January 2008 with a sample of 4000 residents ( aged 20 - 69 years and 50 % male ) who were r and omly selected from the registry of residential addresses . Complete responses for both question naire and pedometer were obtained from 790 residents ( 48.3±13.7 years , 46.7 % male ) . Associations of 11 sociodemographic variables with steps per day were examined using multiple logistic regression analyses . Data were analyzed in 2010 . RESULTS Men averaged 8763±3497 steps/day and women averaged 8242±3277 steps/day . Further , 29.0 % of men and 27.8 % of women walked ≥10,000 steps/day . City of residence , good self-rated health , low educational attainment , and not owning a car were associated with taking ≥10,000 steps/day in men , whereas employed status and dog ownership were associated with walking ≥10,000 steps/day in women . CONCLUSIONS The results contribute to underst and ing of step-defined physical activity and its sociodemographic determinants . A diversity of step counts by sociodemographic variables clarifies specific population s among Japanese who are in need of intervention to promote physical activity "
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OBJECTIVE Although benzodiazepines ( BZDs ) are commonly used in the treatment of posttraumatic stress disorder ( PTSD ) , no systematic review or meta- analysis has specifically examined this treatment . The goal of this study was to analyze and summarize evidence concerning the efficacy of BZDs in treating PTSD . METHODS The review protocol was undertaken according to the principles recommended by the Preferred Reporting Items for Systematic Review s and Meta-Analyses ( PRISMA ) statement and is registered with the PROSPERO international prospect i ve register of systematic review s ( http://www.crd.york.ac.uk/ PROSPERO , registration number CRD42014009318 ) . Two authors independently conducted a search of all relevant articles using multiple electronic data bases and independently abstract ed information from studies measuring PTSD outcomes in patients using BZDs . Eighteen clinical trials and observational studies were identified , with a total of 5236 participants . Outcomes were assessed using qualitative and quantitative syntheses , including meta- analysis . RESULTS BZDs are ineffective for PTSD treatment and prevention , and risks associated with their use tend to outweigh potential short-term benefits . In addition to adverse effects in general population s , BZDs are associated with specific problems in patients with PTSD : worse overall severity , significantly increased risk of developing PTSD with use after recent trauma , worse psychotherapy outcomes , aggression , depression , and substance use . Potential biopsychosocial explanations for these results are proposed based on studies that have investigated BZDs , PTSD , and relevant animal models . CONCLUSIONS The results of this systematic review suggest that BZDs should be considered relatively contraindicated for patients with PTSD or recent trauma . Evidence -based treatments for PTSD should be favored over BZDs | [
"BACKGROUND In light of clinical reports suggesting that early benzodiazepine administration interferes with long-term recovery from traumatic stress , a prospect i ve animal model for PTSD was employed to assess the short- and long-term effects of a brief course of alprazolam following stress exposure . METHOD Animals exposed to stress were treated either 1 h or 7 days later with alprazolam or vehicle for 3-days . Outcome measures included behavior in the elevated plus-maze ( EPM ) and acoustic startle response ( ASR ) tests 30 days after initial exposure and freezing behavior upon exposure to a trauma-cue on day 31 . One group was repeatedly exposed to the triggering trauma shortly before and after treatment and assessed as above . Circulating corticosterone levels were assessed 4 h after initiation of alprazolam and post-treatment . Pre-set cut-off behavioral criteria classified exposed animals according to their EPM and ASR response-patterns into ' extreme ' , ' minimal , ' or ' partial ' behavioral response for analysis of prevalence rates . RESULTS Immediate alprazolam treatment was effective in alleviating anxiety at day 4 . No observable anxiolytic effects remained at day 30 . Immediate alprazolam also result ed in significantly greater freezing response to trauma-cue exposure and in extreme responses to double-exposure . Corticosterone levels were significantly suppressed by alprazolam during treatment and rebounded after cessation . CONCLUSION A brief course of alprazolam in the immediate aftermath of stress-exposure is associated with less favorable responses to additional stress-exposure later on . Alprazolam was associated with a significant attenuation of the HPA-response , suggesting a possible link between initial HPA-axis response disruption and the subsequent unfavorable outcomes",
"Veterans with posttraumatic stress disorder ( PTSD ) and substance abuse may abuse benzodiazepines and develop violent dyscontrol when using them . A total of 370 veterans were compared by substance abuse diagnosis ( 50 % ) , benzodiazepine use ( 36 % ) , and their interaction on 1-year outcomes after inpatient discharge . Substance abusers were less likely to be prescribed benzodiazepines ( 26 % vs. 45 % ) . No outcome showed a differential worsening by substance abuse or benzodiazepines , although some baseline differences were noted . Outpatient health care utilization was lower in benzodiazepine users ( 47 vs. 33 visits ) . Among PTSD patients with comorbid substance abuse , benzodiazepine treatment was not associated with adverse effects on outcome , but it may reduce health care utilization",
"Objectives : To investigate if light sedation favorably affects subsequent patient mental health compared with deep sedation . Symptoms of posttraumatic stress disorder are common in patients after they have undergone prolonged mechanical ventilation and are associated with sedation depth . Design : R and omized , open-label , controlled trial . Setting : Single tertiary care center . Patients : Adult patients requiring mechanical ventilation . Interventions : Patients were r and omized to receive either light ( patient awake and cooperative ) or deep sedation ( patient asleep , awakening upon physical stimulation ) . Measurements and Main Results : Self-reported measures of posttraumatic stress disorder , anxiety , and depression were collected at intensive care unit discharge and 4 wks later . The primary outcomes were symptoms of posttraumatic stress disorder , anxiety , and depression 4 wks after intensive care unit discharge . A total of 137 patients were assigned to either the light ( n = 69 ) or the deep sedation ( n = 68 ) group . Seven patients withdrew consent and one patient was r and omized in error , leaving 129 patients ( n = 65 in light sedation and n = 64 in deep sedation ) available for analysis . At the 4-wk follow-up , patients in the deep sedation group tended to have more posttraumatic stress disorder symptoms ( p = .07 ) ; the deep sedation group had more trouble remembering the event ( 37 % vs. 14 % ; p = .02 ) and more disturbing memories of the intensive care unit ( 18 % vs. 4 % ; p = .05 ) . Patients in the light sedation group had an average one day less being ventilated and 1.5 fewer days in the intensive care unit . There were no differences between the two groups in the occurrence of anxiety and depression , and also no difference in mortality or in the incidence of adverse events . Conclusions : These data suggest that a strategy of light sedation affords benefits with regard to reduction of intensive care unit stay and duration of ventilation without negatively affecting subsequent patient mental health or patient safety",
"Objective Easy triggering of trauma-related episodic memory fragments caused by perceptual cues is tied to strong perceptual priming in the implicit memory system . And among benzodiazepines , only lorazepam has been consistently reported to have an atypical suppression effect on perceptual priming processes . The aim of this study was to investigate the effects of single doses of lorazepam , diazepam , and a placebo on intrusive memories after exposure to a distressing videotape and to explore whether the anti-intrusive effect of lorazepam is acquired as a result of the suppression of perceptual but not conceptual priming processes . Methods Under prospect i ve , r and omized , and double-blind conditions , we compared the anti-intrusion effect of a single dose of lorazepam ( n=22 ) with that of diazepam ( n=22 ) and a placebo ( n=21 ) in young healthy Korean college students following exposure to a traumatic videotape . Results We present the first finding for an anti-intrusion effect of lorazepam . One day after the medication , lorazepam , rather than diazepam or the placebo , significantly reduced the extent of intrusion and data -driven processing of the traumatic information . There were no differences among the three conditions in state anxiety , depression , and an arousal scale throughout the experiment . Conclusion Results from this study suggest the possibility of lorazepam as a c and i date anti-intrusion drug , as well as the cautious use of diazepam in the treatment of PTSD patients . The anti-intrusive effect of lorazepam is directly related to its atypical inhibitory effect on implicit perceptual priming processes . The present study provides support for the enhanced perceptual priming hypothesis of PTSD",
"OBJECTIVE The authors examined the effectiveness of virtual reality exposure augmented with D-cycloserine or alprazolam , compared with placebo , in reducing posttraumatic stress disorder ( PTSD ) due to military trauma . METHOD After an introductory session , five sessions of virtual reality exposure were augmented with D-cycloserine ( 50 mg ) or alprazolam ( 0.25 mg ) in a double-blind , placebo-controlled r and omized clinical trial for 156 Iraq and Afghanistan war veterans with PTSD . RESULTS PTSD symptoms significantly improved from pre- to posttreatment across all conditions and were maintained at 3 , 6 , and 12 months . There were no overall differences in symptoms between D-cycloserine and placebo at any time . Alprazolam and placebo differed significantly on the Clinician-Administered PTSD Scale score at posttreatment and PTSD diagnosis at 3 months posttreatment ; the alprazolam group showed a higher rate of PTSD ( 82.8 % ) than the placebo group ( 47.8 % ) . Between-session extinction learning was a treatment-specific enhancer of outcome for the D-cycloserine group only . At posttreatment , the D-cycloserine group had the lowest cortisol reactivity and smallest startle response during virtual reality scenes . CONCLUSIONS A six-session virtual reality treatment was associated with reduction in PTSD diagnoses and symptoms in Iraq and Afghanistan veterans , although there was no control condition for the virtual reality exposure . There was no advantage of D-cycloserine for PTSD symptoms in primary analyses . In secondary analyses , alprazolam impaired recovery and D-cycloserine enhanced virtual reality outcome in patients who demonstrated within-session learning . D-cycloserine augmentation reduced cortisol and startle reactivity more than did alprazolam or placebo , findings that are consistent with those in the animal literature",
"Introduction Post-traumatic stress disorder ( PTSD ) has been identified in a significant portion of intensive care unit ( ICU ) survivors . We sought to identify factors associated with PTSD symptoms in patients following critical illness requiring mechanical ventilation . Methods Forty-three patients who were mechanically ventilated in the medical and coronary ICUs of a university-based medical center were prospect ively followed during their ICU admission for delirium with the Confusion Assessment Method for the ICU . Additionally , demographic data were obtained and severity of illness was measured with the APACHE II ( Acute Physiology and Chronic Health Evaluation II ) score . Six months after discharge , patients were screened for PTSD symptoms by means of the Post-Traumatic Stress Syndrome 10- Questions Inventory ( PTSS-10 ) . Multiple linear regression was used to assess the association of potential risk factors with PTSS-10 scores . Results At follow-up , six ( 14 % ) patients had high levels of PTSD symptoms . On multivariable analysis , women had higher PTSS-10 scores than men by a margin of 7.36 points ( 95 % confidence interval [ CI ] 1.62 to 13.11 ; p = 0.02 ) . Also , high levels of PTSD symptoms were less likely to occur in older patients , with symptoms declining after age 50 ( p = 0.04 ) . Finally , although causation can not be assumed , the total dose of lorazepam received during the ICU stay was associated with PTSD symptoms ; for every 10-mg increase in cumulative lorazepam dose , PTSS-10 score increased by 0.39 ( 95 % CI 0.17 to 0.61 ; p = 0.04 ) . No significant relationship was noted between severity of illness and PTSD symptoms or duration of delirium and PTSD symptoms . Conclusion High levels of PTSD symptoms occurred in 14 % of patients six months following critical illness necessitating mechanical ventilation , and these symptoms were most likely to occur in female patients and those receiving high doses of lorazepam . High levels of PTSD symptoms were less likely to occur in older patients",
"The authors report a r and om-assignment , double-blind crossover trial comparing alprazolam and placebo in posttraumatic stress disorder ( PTSD ) . Ten patients fulfilling DSM-III criteria for PTSD completed 5 weeks of treatment on each agent . Improvement in anxiety symptoms was significantly greater during alprazolam treatment but modest in extent . Symptoms specific to PTSD were not significantly altered . The impact of nonspecific symptomatic effects on the outcome of drug trials in PTSD is considered",
"Objective This prospect i ve observational study was design ed to explore the relationships between post-traumatic stress disorder ( PTSD ) , patients ' memories of the intensive care unit ( ICU ) and sedation practice s. Design Prospect i ve multi-centre follow-up study out to 3 months after ICU discharge . Setting Two district general hospitals and three teaching hospitals across Europe . Patients and participants Two hundred and thirty-eight recovering , post-ventilated ICU patients . Interventions None . Measurements and results Assessment of patients ' memories of ICU was undertaken at 1–2 weeks post ICU discharge . Patients ' psychological recovery was assessed by examining the level of PTSD-related symptoms and rate of PTSD by 3 months post ICU . The rate of defined PTSD was 9.2 % , ranging from 3.2 % to 14.8 % in the different study ICUs . Independent of case mix and illness severity , the factors found to be related to the development of PTSD were recall of delusional memories , prolonged sedation , and physical restraint with no sedation . Conclusion The development of PTSD following critical illness is associated with a number of different precipitating factors that are in part related to how patients are cared for within intensive care . This study raises the hypothesis that the impact of care within the ICU has an impact on subsequent psychological morbidity and therefore must be assessed in future studies looking at the way patients are se date d in the ICU and how physical restraint is used",
"OBJECTIVE Evidence from pre clinical and clinical studies suggests a role for alterations in the benzodiazepine/GABAA receptor complex in stress and anxiety . Flumazenil is a relatively pure benzodiazepine/GABAA antagonist with limited intrinsic activity . In panic disorder patients , but not healthy controls , flumazenil has been demonstrated to provoke panic attacks . METHOD Vietnam combat veterans with PTSD ( n = 14 ) received 90-second intravenous infusions of flumazenil 2 mg or placebo in a double-blind , crossover study design . PTSD symptomology was assessed using the PTSD Symptom Scale , and anxiety symptoms were measured with visual analogue rating scales . RESULTS There was no significant difference in PTSD and anxiety symptoms between administration of flumazenil and placebo . CONCLUSION Flumazenil administration does not produce an increase in anxiety and PTSD symptoms in patients with PTSD . This suggests that PTSD and panic disorder are dissimilar in terms of benzodiazepine/GABAA system function",
"OBJECTIVE Benzodiazepines , other anxiolytics , or sedative hypnotics are prescribed for 30%-50 % of posttraumatic stress disorder ( PTSD ) patients . Prior data and theory suggest that these medications may inhibit response to exposure therapy , one of the most effective PTSD treatments . The present post hoc study reanalyzed results from a psychotherapy trial to assess whether benzodiazepine use was associated with reduced response to exposure therapy . METHOD Between August 2002 and October 2005 , 283 female veterans and soldiers meeting DSM-IV criteria for PTSD were r and omly assigned to 10 weekly 90-minute sessions of either prolonged exposure ( n = 140 ) or present-centered psychotherapy ( n = 143 ) . Benzodiazepine use ( n = 57 ) or non-use ( n = 226 ) at intake was not r and omly assigned . Multilevel modeling was used to assess the effects of benzodiazepine status , psychotherapy condition , and their interaction on changes on the Clinician-Administered PTSD Scale and the PTSD Checklist during the treatment and 6-month follow-up periods . RESULTS Consistent with prior reports from these data , prolonged exposure psychotherapy produced greater reductions per week in PTSD symptoms than did present-centered psychotherapy ( b = -0.48 , P = .02 ) . Patients prescribed benzodiazepines did not have weaker response to prolonged exposure , but demonstrated poorer posttreatment maintenance of gains from present-centered psychotherapy ( b = -0.78 , P Prolonged exposure is a sufficiently robust treatment that patients who are taking benzodiazepines can benefit from it . It is unclear whether benzodiazepine use or other patient factors accounted for benzodiazepine recipients ' poorer maintenance of gains in present-centered psychotherapy . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00032617",
"BACKGROUND : Clonazepam is widely used for the treatment of posttraumatic stress disorder (PTSD)—related sleep disturbances despite very limited published data supporting its use for this indication . OBJECTIVE : We conducted a pilot-controlled trial to provide more data on this clinical practice and lay the foundation for more definitive studies . METHODS : The study was design ed as a r and omized , single-blind ( ie , patient only ) , placebo-controlled , crossover clinical trial involving administration of clonazepam 1 mg at bedtime for one week followed by 2 mg at bedtime for one week . The following week served as a washout period before the alternate treatment was begun . Patients completed sleep diaries each morning upon awakening throughout the study . Parameters included quantity of sleep , quality of sleep , frequency and intensity of difficulty falling or staying asleep , and frequency and intensity of recurrent distressing dreams . RESULTS : Six patients with combat-related PTSD participated in the study . There were no statistically significant differences between clonazepam and placebo for any measure , although clonazepam therapy result ed in mild to moderate numeric improvements in difficulty falling or staying asleep . Adverse effects of clonazepam were generally mild and essentially indiscernible from those attributed to placebo . Only one patient elected to receive further treatment with clonazepam at the conclusion of the trial . CONCLUSIONS : Clonazepam therapy was largely ineffective in improving sleep disturbances , particularly nightmares , associated with combat-related PTSD . The small sample size was a significant limitation of this study , but the prospect i ve design and single-blind , placebo-control parameters were strengths . Further studies are needed to further define the role of this widespread clinical practice",
"BACKGROUND Most types of psychotropic drugs have been tried in the treatment of chronic posttraumatic stress disorder ( PTSD ) , but have yielded limited results . Theory and retrospective research predict that early treatment may be more efficacious . Specifically , high-potency benzodiazepines have been recommended for the treatment of acute responses to trauma and for prevention of PTSD . This study prospect ively evaluates the effect of early administration of benzodiazepines on the course of PTSD and PTSD symptoms . METHOD Thirteen trauma survivors ( the benzodiazepine group ) were treated within 6.7 + /- 5.8 days after the trauma ( range , 2 - 18 ) with either clonazepam ( N = 10 , 2.7 + /- 0.8 mg/day ) or alprazolam ( N = 3 , 2.5 mg/day ) . Thirteen other trauma survivors , pair-matched with subjects in the active treatment group for gender and symptom severity in the first week after the trauma , constitute the control group . Both groups were reevaluated 1 and 6 months after the trauma for PTSD symptoms ( Horowitz Impact of Event Scale ; Mississippi Rating Scale for Combat-Related PTSD-civilian trauma version ) , PTSD status ( Clinician Administered PTSD Scale ) , state anxiety , depression , and resting heart rate . RESULTS Subjects in the benzodiazepine group did not differ from controls in 1-month and 6-month PTSD and anxiety scores . Repeated measures ANOVA showed no group or group-by-time effect on psychometric measures . A trend toward group-by-time interaction in resting heart rate was noted ( progressive decrease in the benzodiazepine group ) . Nine benzodiazepine subjects and 3 controls met PTSD diagnostic criteria 6 months after the trauma . CONCLUSION Contrary to expectations , the early administration of benzodiazepines to trauma survivors with high levels of initial distress did not have a salient beneficial effect on the course of their illness , while reducing physiologic expression of arousal"
] | 41163e68-06ff-11f0-808a-c43d1ab1c353 |
A systematic review was conducted to determine the extent to which an economic case has been made in high-income countries for investment in interventions to promote mental health and well-being . We focused on areas of interest to the Data Prev project : early years and parenting interventions , actions set in schools and workplaces and measures targeted at older people . Economic evaluations had to have some focus on promotion of mental health and well-being and /or primary prevention of poor mental health through health-related means . Studies preventing exacerbations in existing mental health problems were excluded , with the exception of support for parents with mental health problems , which might indirectly affect the mental health of their children . Overall 47 studies were identified . There was considerable variability in their quality , with a variety of outcome measures and different perspectives : societal , public purse , employer or health system used , making policy comparisons difficult . Caution must therefore be exercised in interpreting results , but the case for investment in parenting and health visitor-related programmes appears most strong , especially when impacts beyond the health sector are taken into account . In the workplace an economic return on investment in a number of comprehensive workplace health promotion programmes and stress management projects ( largely in the USA ) was reported , while group-based exercise and psychosocial interventions are of potential benefit to older people . Many gaps remain ; a key first step would be to make more use of the existence evidence base on effectiveness and model mid- to long-term costs and benefits of action in different context s and setting | [
"OBJECTIVES To evaluate the cost-effectiveness of a 9-month preventive occupational therapy ( OT ) program in the Well-Elderly Study : a r and omized trial in independent-living older adults that found significant health , function , and quality of life benefits attributable to preventive OT . DESIGN A r and omized trial . SETTING Two government-subsidized apartment complexes . PARTICIPANTS One hundred sixty-three culturally diverse volunteers aged 60 and older . INTERVENTION An OT group , a social activity group ( active control ) , and a nontreatment group ( passive control ) . MEASUREMENTS Use of healthcare services was determined by telephone interview during and after the treatment phase . A conversion algorithm was applied to the R AND 36-item Short Form Health Survey to derive a preference-based health-related quality of life index , quality -adjusted life years ( QALYs ) , and the incremental cost-effectiveness ratio for preventive OT relative to the combined control group . RESULTS Costs for the 9-month OT program averaged $ 548 per subject . Postintervention healthcare costs were lower for the OT group ( $ 967 ) than for the active control group ( $ 1,726 ) , the passive control group ( $ 3,334 ) , or a combination of the control groups ( $ 2,593 ) . The quality of life index showed a 4.5 % QALY differential ( OT vs combined control ) , P cost per QALY estimates for the OT group was $ 10,666 ( 95 % confidence interval = $ 6,747-$25,430 ) . For the passive and active control groups , the corresponding costs per QALY were $ 13,784 and $ 7,820 , respectively . CONCLUSION In this study , preventive OT demonstrated cost-effectiveness in conjunction with a trend toward decreased medical expenditures",
"Background Workplace mental health promotion ( WMHP ) aims to prevent and effectively manage the social and economic costs of common mental illnesses such as depression . The mental health of managers and employees within small-medium enterprises ( SMEs ) is a neglected sector in occupational health research and practice , despite the fact that this sector is the most common work setting in most economies . The availability and propensity of SME staff to attend face-to-face training/therapy or workshop style interventions often seen in corporate or public sector work setting s is a widely recognised problem . The ' Business in Mind ' program employs a DVD mode of delivery that is convenient for SME managers , particularly those operating in regional and remote areas where internet delivery may not be optimal . The objective of the intervention program is to improve the mental health of SME managers , and examine whether employees of managers ' whose mental health improves , report positive change in their psychosocial work environment . The mechanisms via which we aim to improve managers ' mental health are through the development of their psychological capital ( a higher order construct comprised of hope , self efficacy , resilience and optimism ) and their skills and capacities for coping with work stress . Methods / Design The effectiveness of two versions of the program ( self administered and telephone facilitated ) will be assessed using a r and omised trial with an active control condition ( psychoeducation only ) . We aim to recruit a minimum of 249 managers and a sample of their employees . This design allows for 83 managers per group , as power analyses showed that this number would allow for attrition of 20 % and still enable detection of an effect size of 0.5 . The intervention will be implemented over a three month period and postal surveys will assess managers and employees in each group at baseline , intervention completion , and at 6 month follow up . The intervention groups ( managers only ) will also be assessed at 12 and 24 month follow-up to examine maintenance of effects . Primary outcomes are managers ' levels of psychological capital ( hope , resilience , self-efficacy and optimism ) , coping strategies , anxiety and depression symptoms , self-reported health , job satisfaction and job tension . Secondary outcomes are participating managers subordinates ' perceptions of manager support , relational justice , emotional climate and job tension . In order to provide an economic evaluation of the intervention , both employees and manager rates of absenteeism and presenteeism will also be assessed . Discussion The intervention being trialled is expected to improve both primary and secondary outcomes . If proven efficacious , the intervention could be disseminated to reach a much larger proportion of the business community . Trial registration Current controlled trials IS RCT N",
"Background Depression in older adults is a serious health problem with a poor prognosis . There is a need for indicated preventive psychological interventions for older adults , that show to be promising in preventing depressive disorders . Methods / design This manuscript describes the design of a study evaluating ' Looking for Meaning ' , a newly developed prevention course for older adults with depressive symptoms , based on life- review . Both clinical and economic effectiveness are evaluated in a pragmatic r and omized controlled trial . The control condition of this 12-session preventive intervention is a 20-minute video movie . The primary outcome is symptoms of depression at post-treatment and follow-up ( 6 months after post-treatment ) . Secondary outcomes are symptoms of anxiety , satisfaction with life , mastery , reminiscence styles , quality of life , and health care costs . An additional result of this study is the insight into the working elements of the course , provided by the qualitative study . The qualitative data , mainly based on 20 open-ended interviews with participants , are to be analyzed with an emphasis on newly emerging insight . Discussion This study will add to the existing scientific knowledge in several ways , especially by also including an economic evaluation and a qualitative study to gain insight into the working mechanisms of the course , both rather new in the field of life review . Positive results of this study will make an evidence -based intervention to improve public health among older people available . Trial registration Current Controlled Trials Ltd , IS RCT",
"OBJECTIVES : To evaluate the effectiveness of a home visiting program on health-related measures in a population of older people with poor health status . DESIGN : R and omized , clinical trial . SETTING : Community-dwelling citizens in the Netherl and s. PARTICIPANTS : Three hundred thirty people aged 70 to 84 r and omly assigned to an intervention group ( n=160 ) or a control group ( n=170 ) . INTERVENTION : Eight home visits , lasting 1 hour or more , with telephone follow-up , over an 18-month period , conducted by experienced home nurses under supervision of a public health nurse ; key elements of the ( systematic ) visits were assessment of health problems and risks , advice , and referral to professional and community services . MEASUREMENTS : Self-rated health , functional status , quality of life , and changes in self-reported problems . RESULTS : No differences were found between the intervention and control group in these and other outcome measures at the end of the intervention",
"Abstract Objectives : To establish the relative cost effectiveness of postnatal support in the community in addition to the usual care provided by community midwives . Design : R and omised controlled trial with six month follow up . Setting : Recruitment in a university teaching hospital and care provided in women 's homes . Participants : 623 postnatal women allocated at r and om to intervention ( 311 ) or control ( 312 ) group . Intervention : Up to 10 home visits in the first postnatal month of up to three hours duration by a community postnatal support worker . Main outcome measure : General health status as measured by the SF-36 and risk of postnatal depression . Breast feeding rates , satisfaction with care , use of services , and personal costs . Results : At six weeks there was no significant improvement in health status among the women in the intervention group . At six weeks the mean total NHS costs were £ 635 for the intervention group and £ 456 for the control group ( P=0.001 ) . At six months figures were £ 815 and £ 639 ( P=0.001 ) . There were no differences between the groups in use of social services or personal costs . The women in the intervention group were very satisfied with the support worker visits . Conclusions : There was no health benefit of additional home visits by community postnatal support workers compared with traditional community midwifery visiting as measured by the SF-36 . There were no savings to the NHS over six months after the introduction of the community postnatal support worker service",
"Study objective : To evaluate the effect of two forms of postnatal social support for disadvantaged inner city mothers on maternal and child health outcomes . Design : R and omised controlled trial with economic and process evaluations and follow up at 12 and 18 months . The two intervention groups received either the offer of a year of monthly supportive listening home visits by a support health visitor ( SHV ) , or a year of support from community groups providing drop in sessions , home visiting and /or telephone support ( CGS ) . Each was compared with a control group that received st and ard health visitor services . Setting : Two disadvantaged boroughs of London , United Kingdom . Participants : 731 women from culturally diverse background s with infants . Main results : At 12 and 18 months , there was little impact for either intervention on the main outcomes : child injury ( SHV : relative risk 0.99 ; 95 % confidence intervals 0.68 to 1.45 , CGS : 0.91 ; 0.61 to1.36 ) , maternal smoking ( SHV : 0.86 ; 0.62 to 1.19 , CGS : 0.97 ; 0.72 to 1.33 ) or maternal depression ( SHV : 0.86 ; 0.62 to1.19 , CGS : 0.93 ; 0.69 to 1.27 ) . SHV women had different patterns of health service use ( with fewer taking their children to the GP ) and had less anxious experiences of motherhood than control women . User satisfaction with the SHV intervention was high . Uptake of the CGS intervention was low : 19 % , compared with 94 % for the SHV intervention . Conclusions : There was no evidence of impact on the primary outcomes of either intervention among this culturally diverse population . The SHV intervention was associated with improvement in some of the secondary outcomes",
"Background : The impact of depression on the workplace has been widely observed in studies examining absenteeism and reduced productivity during days at work . However , there is little scientific evidence about whether depression interventions are cost-beneficial to employers . Objective : We construct a cost – benefit analysis of depression treatment under different workplace assumptions better reflecting the nature of employment . Research Design : Data from a r and omized controlled trial in which employed primary care patients with depression were treated in practice s r and omly assigned to an enhanced treatment intervention or usual care were used to construct a cost – benefit model from an employer perspective under different assumptions regarding employment . Subjects : A national sample of 198 workers employed in a range of positions by companies was studied . Measures : Benefits included self-reported productivity and absenteeism ; costs included intervention and treatment costs . Net benefit was calculated under different scenarios and return on investment ( ROI ) is derived . Results : Enhanced depression treatment result ed in an average net benefit to the employer of $ 30 per participating worker in Year 1 of the intervention and $ 257 per participating worker in Year 2 , for an estimated ROI during the 2-year period of 302 % . ROI increased in firms that rely on team production , hire more costly substitute labor , or realize penalties for output shortfalls . ROI decreased in firms that have a large fraction of employees with dependent coverage and experience high turnover rates . Results also are sensitive to how subjectively reported productivity is valued . Conclusion : Many employers will receive a potentially significant ROI from depression treatment models that improve absenteeism and productivity at work",
"Childhood psychological conditions including depression and substance abuse are a growing concern among American children , but their long-term economic costs are unknown . This paper uses unique data from the US Panel Study of Income Dynamics ( PSID ) following groups of siblings and their parents for up to 40 years prospect ively collecting information on education , income , work , and marriage . Following siblings offers an opportunity to control for unobserved family and neighborhood effects . A retrospective child health history design ed by the author was placed into the 2007 PSID wave measuring whether respondents had any of 14 childhood physical illnesses or suffered from depression , substance abuse , or other psychological conditions . Large effects are found on the ability of affected children to work and earn as adults . Educational accomplishments are diminished , and adult family incomes are reduced by 20 % or $ 10,400 per year with $ 18,000 less family household assets . Lost income is partly a consequence of seven fewer weeks worked per year . There is also an 11 % point lower probability of being married . Controlling for physical childhood diseases shows that these effects are not due to the co-existence of psychological and physical diseases , and estimates controlling for within-sibling differences demonstrate that these effects are not due to unobserved common family differences . The long-term economic damages of childhood psychological problems are large-a lifetime cost in lost family income of approximately $ 300,000 , and total lifetime economic cost for all those affected of 2.1 trillion dollars",
"Objective To investigate the cost effectiveness of a parenting programme . Design An incremental cost effectiveness analysis alongside a pragmatic r and omised controlled trial of the effectiveness of a group parenting programme delivered through Sure Start in the community . Setting Sure Start areas in north and mid Wales . Participants Parents of 116 children aged 36 - 59 months ( 87 % of the clinical sample ) at risk of developing conduct disorders defined by scoring over the clinical cut off on the Eyberg child behaviour inventory ) . Children were identified by health visitors and recruited by the research team . Intervention The Webster-Stratton Incredible Years basic parenting programme or a six month waiting list control . Main outcome measure Incremental cost per unit of improvement on the intensity score of the Eyberg child behaviour inventory . Results The bootstrapped incremental cost effectiveness ratio point estimate was � 73 ( € 109 , $ 142 ) per one point improvement on the intensity score ( 95 % confidence interval � 42 to � 140 ) . It would cost � 5486 ( € 8190 , $ 10 666 ) to bring the child with the highest intensity score to below the clinical cut-off point and � 1344 ( € 2006 , $ 2618 ) to bring the average child in the intervention group within the non- clinical limits on the intensity score ( below 127 ) . For a ceiling ratio of � 100 ( € 149 , $ 194 ) per point increase in intensity score , there is an 83.9 % chance of the intervention being cost effective . The mean cost per child attending the parenting group was � 1934 ( € 2887 , $ 3760 ) for eight children and � 1289 ( € 1924 , $ 2506 ) for 12 children , including initial costs and material s for training group leaders . When we categorised the sample into relatively mild , moderate , and severe behaviour groups based on intensity scores at baseline the intervention seemed more cost effective in those with the highest risk of developing conduct disorder . Conclusion This parenting programme improves child behaviour as measured by the intensity score of the Eyberg child behaviour inventory at a relatively low cost and was cost effective compared with the waiting list control . This parenting programme involves modest costs and demonstrates strong clinical effect , suggesting it would represent good value for money for public spending",
"BACKGROUND Parenting programs have been shown to work when delivered to motivated ethnic majority parents in demonstration projects , but comparatively little is known about their impact when delivered to high-risk , multi-ethnic population s by routine local services . METHODS The Primary Age Learning Skills ( PALS ) trial was a r and omized controlled trial of an evidence -based parenting-group program that targeted the parent-child relationship and child literacy . Parents of 174 children were selected from a population of 672 5- and 6-year-olds attending four primary schools in a high-risk , ethnically diverse , inner-city area . Eighty-eight children were allocated to the Incredible Years preventive program plus a shortened six-week version of the SPOKES literacy program , delivered by local services ; 86 to usual community services ; 152/174 ( 87 % ) of families were successfully followed up . Parent-child relationship quality and child behavior were measured using direct observation and parent interview ; child reading was assessed psychometrically . RESULTS Two-thirds ( 58/89 ) of those offered the parenting program attended at least one session , with similar enrollment rates across the Black African , African-Caribbean , White-British and Other ethnic groups . Mean attendance was four relationship-building sessions and one literacy-development session . Satisfaction question naires were completed by 43/58 starters ; 93 % said they were well or extremely satisfied , with equally high rates across ethnic groups . At follow-up after one year , those allocated to the intervention showed significant improvements in the parent-child relationship on observation and at interview compared to controls ; effects were similar across all ethnic groups . However , child behavior problems and reading did not improve . The cost was £ 1,343 ( $ 2,100 ) per child . CONCLUSIONS Programs can be organized to be engaging and effective in improving parenting among high-risk , multi-ethnic communities , which is of considerable value . To also be cost-effective in achieving child changes may require a set-up that enables parents to attend more sessions and /or an exclusive focus on children with clinical ly significant behavior problems",
"CONTEXT Home-visitation services have been promoted as a means of improving maternal and child health and functioning . However , long-term effects have not been examined . OBJECTIVE To examine the long-term effects of a program of prenatal and early childhood home visitation by nurses on women 's life course and child abuse and neglect . DESIGN R and omized trial . SETTING Semirural community in New York . PARTICIPANTS Of 400 consecutive pregnant women with no previous live births enrolled , 324 participated in a follow-up study when their children were 15 years old . INTERVENTION Families received a mean of 9 home visits during pregnancy and 23 home visits from the child 's birth through the second birthday . DATA SOURCES AND MEASURES : Women 's use of welfare and number of subsequent children were based on self-report ; their arrests and convictions were based on self-report and archived data from New York State . Verified reports of child abuse and neglect were abstract ed from state records . MAIN RESULTS During the 15-year period after the birth of their first child , in contrast to women in the comparison group , women who were visited by nurses during pregnancy and infancy were identified as perpetrators of child abuse and neglect in 0.29 vs 0.54 verified reports ( P women who were unmarried and from households of low socioeconomic status at initial enrollment , in contrast to those in the comparison group , nurse-visited women had 1.3 vs 1.6 subsequent births ( P=.02 ) , 65 vs 37 months between the birth of the first and a second child ( P=.001 ) , 60 vs 90 months ' receiving Aid to Families With Dependent Children ( P=.005 ) , 0.41 vs 0.73 behavioral impairments due to use of alcohol and other drugs ( P=.03 ) , 0.18 vs 0.58 arrests by self-report ( P arrests disclosed by New York State records ( P prenatal and early childhood home visitation by nurses can reduce the number of subsequent pregnancies , the use of welfare , child abuse and neglect , and criminal behavior on the part of low-income , unmarried mothers for up to 15 years after the birth of the first child",
"Background Despite a growing underst and ing of the effectiveness of bereavement interventions and the groups that benefit most from them , we know little about the cost-effectiveness of bereavement interventions . Methods We conducted a cost-utility analysis alongside a r and omized clinical trial on a visiting service for older widowed individuals ( n = 110 ) versus care as usual ( CAU ; n = 106 ) . The visiting service is a selective bereavement intervention that offers social support to lonely widows and widowers by a trained volunteer . Participants were contacted 6–9 months post-loss . Eleven percent of all contacted persons responded and eight percent participated in the trial . The primary outcome measure was quality adjusted life years ( QALYs ) gained ( assessed with the EQ-5D ) , which is a generic measure of health status . Costs were calculated from a societal perspective excluding costs arising from productivity losses . Using the bootstrap method , we obtained the incremental cost utility ratio ( ICUR ) , projected these on a cost-utility plane and presented as an acceptability curve . Results Overall , the experimental group demonstrated slightly better results against slightly higher costs . Whether the visiting service is acceptable depends on the willingness to pay : at a willingness to pay equal to zero per QALY gained , the visiting service has a probability of 31 % of being acceptable ; beyond € 20,000 , the visiting service has a probability of 70 % of being more acceptable than CAU . ConclusionS elective bereavement interventions like the visiting service will not produce large benefits from the health economic point of view , when targeted towards the entire population of all widowed individuals . We recommend that in depth analyses are conducted to identify who benefits most from this kind of interventions , and in what subgroups the incremental cost-utility is best . In the future bereavement interventions are then best directed to these groups . Trial registration Controlled trials IS RCT",
"OBJECTIVE To examine the long-term effects of an intervention combining teacher training , parent education , and social competence training for children during the elementary grade s on adolescent health-risk behaviors at age 18 years . DESIGN Nonr and omized controlled trial with follow-up 6 years after intervention . SETTING Public elementary schools serving high-crime areas in Seattle , Wash. PARTICIPANTS Of the fifth- grade students enrolled in participating schools , 643 ( 76 % ) were given written parental consent for the longitudinal study and 598 ( 93 % ) were followed up and interviewed at age 18 years . INTERVENTIONS A full intervention provided in grade s 1 through 6 of 5 days of in-service training for teachers each intervention year , developmentally appropriate parenting classes offered to parents when children were in grade s 1 through 3 and 5 through 6 , and developmentally adjusted social competence training for children in grade s 1 and 6 . A late intervention , provided in grade s 5 and 6 only , paralleled the full intervention at these grade s. MAIN OUTCOME MEASURES Self-reported violent and nonviolent crime , substance use , sexual activity , pregnancy , bonding to school , school achievement , grade repetition and school dropout , suspension and /or expulsion , and school misbehavior ; delinquency charges from court records ; grade point average ; California Achievement Test scores : and disciplinary action reports from school records . RESULTS Fewer students receiving full intervention than control students reported violent delinquent acts ( 48.3 % vs 59.7 % ; P=.04 ) , heavy drinking ( 15.4 % vs 25.6 % ; P=.04 ) , sexual intercourse ( 72.1 % vs 83.0 % ; P=.02 ) , having multiple sex partners ( 49.7 % vs 61.5 % ; P=.04 ) , and pregnancy or causing pregnancy ( 17.1 % vs 26.4 % ; P=.06 ) by age 18 years . The full intervention student group reported more commitment ( P=.03 ) and attachment ( P=.006 ) to school , better academic achievement ( P=.01 ) , and less school misbehavior ( P=.02 ) than control students . Late intervention in grade s 5 and 6 only did not significantly affect health-risk behaviors in adolescence . CONCLUSIONS A package of interventions with teachers , parents , and children provided throughout the elementary grade s can have enduring effects in reducing violent behavior , heavy drinking , and sexual intercourse by age 18 years among multiethnic urban children . Results are consistent with the theoretical model guiding the intervention and support efforts to reduce health-risk behaviors through universal interventions in selected communities or schools serving high-crime neighborhoods",
"OBJECTIVE To examine the effectiveness of home visiting by paraprofessionals and by nurses as separate means of improving maternal and child health when both types of visitors are trained in a program model that has demonstrated effectiveness when delivered by nurses . METHODS A r and omized , controlled trial was conducted in public- and private-care setting s in Denver , Colorado . One thous and one hundred seventy-eight consecutive pregnant women with no previous live births who were eligible for Medicaid or who had no private health insurance were invited to participate . Seven hundred thirty-five women were r and omized to control , paraprofessional , or nurse conditions . Nurses completed an average of 6.5 home visits during pregnancy and 21 visits from birth to the children 's second birthdays . Paraprofessionals completed an average of 6.3 home visits during pregnancy and 16 visits from birth to the children 's second birthdays . The main outcomes consisted of changes in women 's urine cotinine over the course of pregnancy ; women 's use of ancillary services during pregnancy ; subsequent pregnancies and births , educational achievement , workforce participation , and use of welfare ; mother-infant responsive interaction ; families ' home environments ; infants ' emotional vulnerability in response to fear stimuli and low emotional vitality in response to joy and anger stimuli ; and children 's language and mental development , temperament , and behavioral problems . RESULTS Paraprofessional-visited mother-child pairs in which the mother had low psychological re sources interacted with one another more responsively than their control-group counterparts ( 99.45 vs 97.54 st and ard score points ) . There were no other statistically significant paraprofessional effects . In contrast to their control-group counterparts , nurse-visited smokers had greater reductions in cotinine levels from intake to the end of pregnancy ( 259.0 vs 12.32 ng/mL ) ; by the study child 's second birthday , women visited by nurses had fewer subsequent pregnancies ( 29 % vs 41 % ) and births ( 12 % vs 19 % ) ; they delayed subsequent pregnancies for longer intervals ; and during the second year after the birth of their first child , they worked more than women in the control group ( 6.83 vs 5.65 months ) . Nurse-visited mother-child pairs interacted with one another more responsively than those in the control group ( 100.31 vs 98.99 st and ard score points ) . At 6 months of age , nurse-visited infants , in contrast to their control-group counterparts , were less likely to exhibit emotional vulnerability in response to fear stimuli ( 16 % vs 25 % ) and nurse-visited infants born to women with low psychological re sources were less likely to exhibit low emotional vitality in response to joy and anger stimuli ( 24 % vs 40 % and 13 % vs 33 % ) . At 21 months , nurse-visited children born to women with low psychological re sources were less likely to exhibit language delays ( 7 % vs 18 % ) ; and at 24 months , they exhibited superior mental development ( 90.18 vs 86.20 Mental Development Index scores ) than their control-group counterparts . There were no statistically significant program effects for the nurses on women 's use of ancillary prenatal services , educational achievement , use of welfare , or their children 's temperament or behavior problems . For most outcomes on which either visitor produced significant effects , the paraprofessionals typically had effects that were about half the size of those produced by nurses . CONCLUSIONS When trained in a model program of prenatal and infancy home visiting , paraprofessionals produced small effects that rarely achieved statistical or clinical significance ; the absence of statistical significance for some outcomes is probably attributable to limited statistical power to detect small effects . Nurses produced significant effects on a wide range of maternal and child outcomes",
"Background Preventive interventions are developed for children of parents with mental and substance use disorders ( COPMI ) , because these children have a higher risk of developing a psychological or behavioral disorder in the future . Mental health and substance use disorders contribute significantly to the global burden of disease . Although the exact number of parents with a mental illness is unclear , the subject of mentally ill parents is gaining attention . Moreover there is a lack of interventions for COPMI-children , as well of ( cost- ) effectiveness studies evaluating COPMI interventions . Innovative interventions such as e-health provide a new field for exploration . There is no knowledge about the opportunities for using the internet to prevent problems in children at risk . In the current study we will focus on the ( cost- ) effectiveness of an online health prevention program for COPMI-children . Methods / Design We design ed a r and omized controlled trial to examine the ( cost- ) effectiveness of the Kopstoring intervention . Kopstoring is an online intervention for COPMI-children to strengthen their coping skills and prevent behavioral and psychological problems . We will compare the Kopstoring intervention with ( waiting list ) care as usual . This trial will be conducted entirely over the internet . An economic evaluation , from a societal perspective will be conducted , to examine the trial 's cost-effectiveness . Power calculations show that 214 participants are needed , aged 16 - 25 . Possible participants will be recruited via media announcements and banners on the internet . After screening and completing informed consent procedures , participants will be r and omized . The main outcome is internalizing and externalizing symptoms as measured by the Youth Self Report . For the economic evaluation , healthcare costs and costs outside the healthcare sector will be measured at the same time as the clinical measures , at baseline , 3 , 6 and 9 months . An extended measure for the intervention group will be provided at 12 months , to examine the long-term effects . In addition , a process evaluation will be conducted . Discussion Recent developments , such as international conferences and policy discussion s , show the pressing need to study the ( cost- ) effectiveness of interventions for vulnerable groups of children . This study will shed light on the ( cost- ) effectiveness of an online preventive intervention . Trial registration",
"OBJECTIVE To examine the long-term effects of the Seattle Social Development Project intervention in promoting positive adult functioning and preventing mental health problems , crime , and substance use ( including tobacco , alcohol , and other drugs ) at 21 years of age . DESIGN This nonr and omized controlled trial followed up participants to 21 years of age , 9 years after the intervention ended . We compared the following 3 intervention conditions : a full 6-year intervention ( grade s 1 through 6 ) ; a late 2-year intervention ( grade s 5 and 6 only ) ; and a no-treatment control condition . SETTING Eighteen public elementary schools serving diverse neighborhoods , including high-crime neighborhoods , of Seattle , Wash. PARTICIPANTS A sex-balanced , multiethnic sample of 605 participants across the 3 conditions who completed interviews at 21 years of age ( 94 % of the original sample in these conditions ) . INTERVENTIONS Teacher training in classroom instruction and management , child social and emotional skill development , and parent training . MAIN OUTCOME MEASURES Self-reports of functioning in school and work , emotional and mental health , and crime and substance use at 21 years of age and official court records . RESULTS Broad significant effects on functioning in school and work and on emotional and mental health were found . Fewer significant effects on crime and substance use were found at 21 years of age . Most outcomes had a consistent dose effect , with the strongest effects in subjects in the full-intervention group and effects in the late-intervention group between those in the full-intervention and control groups . CONCLUSIONS A theory-guided preventive intervention that strengthened teaching and parenting practice s and taught children interpersonal skills during the elementary grade s had wide-ranging beneficial effects on functioning in early adulthood",
"Background Sub-optimal parenting is a common risk factor for a wide range of negative health , social and educational outcomes . Most parenting programmes have been developed in the USA in the context of delinquency prevention for targeted or indicated groups and the main theoretical underpinning for these programmes is behaviour management . The Family Links Nurturing Programme ( FLNP ) focuses on family relationships as well as behaviour management and is offered on a universal basis . As a result it may be better placed to improve health and educational outcomes . Developed in the UK voluntary sector , FLNP is popular with practitioners , has impressed policy makers throughout the UK , has been found to be effective in before/after and qualitative studies , but lacks a r and omised controlled trial ( RCT ) evidence base . Methods / Design A multi-centre , investigator blind , r and omised controlled trial of the FLNP with a target sample of 288 south Wales families who have a child aged 2 - 4 yrs living in or near to Flying Start/Sure Start areas . Changes in parenting , parent child relations and parent and child wellbeing are assessed with vali date d measures immediately and at 6 months post intervention . Economic components include cost consequences and cost utility analyses based on parental ranking of states of quality of life . Attendance and completion rates and fidelity to the FLNP course delivery are assessed . A nested qualitative study will assess reasons for participation and non-participation and the perceived value of the programme to families . By the end of May 2010 , 287 families have been recruited into the trial across four areas of south Wales . Recruitment has not met the planned timescales with barriers including professional anxiety about families entering the control arm of the trial , family concern about video and audio recording , programme facilitator concern about the recording of FLNP sessions for fidelity purpose s and delays due to the new UK research governance procedures . Discussion Whilst there are strong theoretical arguments to support universal provision of parenting programmes , few universal programmes have been subjected to r and omised controlled trials . In this paper we describe a RCT protocol with quantitative and qualitative outcome measures and an economic evaluation design ed to provide clear evidence with regard to effectiveness and costs . We describe challenges implementing the protocol and how we are addressing these . Trial Registration Current Controlled Trials IS RCT",
"BACKGROUND Sickness absence often occurs in patients with emotional distress or minor mental disorders . In several European countries , these patients are over-represented among those receiving illness benefits , and interventions are needed . The aim of this study was to evaluate the cost-effectiveness of an intervention conducted by social workers , design ed to reduce sick leave duration in patients absent from work owing to emotional distress or minor mental disorders . METHODS In this R and omized Controlled Trial , patients were recruited by GPs . The intervention group ( N = 98 ) received an activating , structured treatment by social workers , the control group ( N = 96 ) received routine GP care . Sick leave duration , clinical symptoms , and medical consumption ( consumption of medical staffs ' time as well as consumption of drugs ) were measured at baseline and 3 , 6 , and 18 months later . RESULTS Neither for sick leave duration nor for clinical improvement over time were significant differences found between the groups . Also the associated costs were not significantly lower in the intervention group . CONCLUSIONS Compared with usual GP care , the activating social work intervention was not superior in reducing sick leave duration , improving clinical symptoms , and decreasing medical consumption . It was also not cost-effective compared with GP routine care in the treatment of minor mental disorders . Therefore , further implementation of the intervention is not justified . Potentially , programmes aim ed at reducing sick leave duration in patients with minor mental disorders carried out closer to the workplace ( e.g. by occupational physicians ) are more successful than programmes in primary care",
"Objective : To assess the cost effectiveness of a community based exercise programme as a population wide public health intervention for older adults . Design : Pragmatic , cluster r and omised community intervention trial . Setting : 12 general practice s in Sheffield ; four r and omly selected as intervention population s , and eight as control population s. Participants : All those aged 65 and over in the least active four fifths of the population responding to a baseline survey . There were 2283 eligible participants from intervention practice s and 4137 from control practice s. Intervention : Eligible subjects were invited to free locally held exercise classes , made available for two years . Main outcome measures : All cause and exercise related cause specific mortality and hospital service use at two years , and health status assessed at baseline , one , and two years using the SF-36 . A cost utility analysis was also undertaken . Results : Twenty six per cent of the eligible intervention practice population attended one or more exercise sessions . There were no significant differences in mortality rates , survival times , or admissions . After adjusting for baseline characteristics , patients in intervention practice s had a lower decline in health status , although this reached significance only for the energy dimension and two composite scores ( p incremental average QALY gain of 0.011 per person in the intervention population result ed in an incremental cost per QALY ratio of € 17 174 ( 95 % CI = € 8300 to € 87 120 ) . Conclusions : Despite a low level of adherence to the exercise programme , there were significant gains in health related quality of life . The programme was more cost effective than many existing medical interventions , and would be practical for primary care commissioning agencies to implement",
"Background Conduct problems are common , disabling and costly . The prognosis for children with conduct problems is poor , with outcomes in adulthood including criminal behaviour , alcoholism , drug abuse , domestic violence , child abuse and a range of psychiatric disorders . There has been a rapid expansion of group based parent-training programmes for the treatment of children with conduct problems in a number of countries over the past 10 years . Existing review s of parent training have method ological limitations such as inclusion of non-r and omised studies , the absence of investigation for heterogeneity prior to meta- analysis or failure to report confidence intervals . The objective of the current study was to systematic ally review r and omised controlled trials of parenting programmes for the treatment of children with conduct problems . Methods St and ard systematic review methods were followed including duplicate inclusion decisions , data extraction and quality assessment . Twenty electronic data bases from the fields of medicine , psychology , social science and education were comprehensively search ed for RCTs and systematic review s to February 2006 . Inclusion criteria were : r and omised controlled trial ; of structured , repeatable parenting programmes ; for parents/carers of children up to the age of 18 with a conduct problem ; and at least one measure of child behaviour . Meta- analysis and qualitative synthesis were used to summarise included studies . Results 57 RCTs were included . Studies were small with an average group size of 21 . Meta-analyses using both parent ( SMD -0.67 ; 95 % CI : -0.91 , -0.42 ) and independent ( SMD -0.44 ; 95 % CI : -0.66 , -0.23 ) reports of outcome showed significant differences favouring the intervention group . There was insufficient evidence to determine the relative effectiveness of different approaches to delivering parenting programmes . Conclusion Parenting programmes are an effective treatment for children with conduct problems . The relative effectiveness of different parenting programmes requires further research",
"Background Dementia is a major public health problem with enormous costs to society and major consequences for both patients and their relatives . Family members of persons with dementia provide much of the care for older adults with dementia in the community . Caring for a demented relative is not easy and fraught with emotional strain , distress , and physical exhaustion . Family caregivers of dementia patients have an extremely high risk developing affective disorders such as major depression and anxiety disorder . Family meetings appear to be among the most powerful psychosocial interventions to reduce depression in caregivers . An American l and mark study reported substantial beneficial effects of a multifaceted intervention where family meetings had a central place on depression in family caregivers as well as on delay of institutionalization of patients . These effects were not replicated in other countries yet . We perform the first trial comparing only structured family meetings with significant others versus usual care among primary family caregivers of community dwelling demented patients and measure the effectiveness on both depression and anxiety in the primary caregiver , both on disorder and symptom levels . Methods / design In this r and omized controlled trial effectiveness as well as cost-effectiveness of family meetings is evaluated . The intervention group receives four family meetings with family and close friends of the primary family caregiver of a community dwelling patient with a clinical diagnosis of dementia . Dyads of patients and their primary caregiver are followed up to one year after baseline assessment . The main outcome measures are the incidence of anxiety and depressive disorders assessed with the Mini-International Neuropsychiatric Interview ( MINI ) and the severity of anxiety and depressive symptoms in caregivers is measured by vali date d self report instruments : the Centre for Epidemiologic Studies Depression Scale ( CES-D ) for depression and the anxiety scales of the Hospital Anxiety and Depression scales ( HADS ) for anxiety . The economic evaluation is performed from a societal perspective . Discussion By evaluating the effectiveness of only structured family meetings organized in the Netherl and s , this study will contribute to the existing literature about the value of psychosocial interventions for dementia caregivers . Trial registration Dutch Trial Registry IS RCT",
"OBJECTIVE Research demonstrates that interventions targeting multiple setting s within a child 's life are more effective in treating or preventing conduct disorder . One such program is the Incredible Years Series , which comprises three treatment components , each focused on a different context and type of daily social interaction that a child encounters . This article explores the cost-effectiveness of stacking multiple intervention components versus delivering single intervention components . METHOD The data involved 459 children , ages 3 to 8 , who participated in clinical trials of the Incredible Years Series . Children r and omized to one of six treatment conditions received one or more of the three following program components : a child-based program , a parent training program , and a teacher-based program instructing teachers in classroom management and in the delivery of a classroom-based social skills curriculum . RESULTS Per-child treatment costs and child behavior outcomes ( observer and teacher reported ) were used to generate cost-effectiveness acceptability curves ; results suggest that stacking intervention components is likely cost-effective , at least for willingness to pay above $ 3,000 per child treated . CONCLUSIONS Economic data may be used to compare competing intervention formats . In the case of this program , providing multiple intervention components was cost-effective",
"A significant percentage of children with disruptive behavior disorders do not receive mental health assistance . Utilization is lowest among groups whose children are at greatest risk . To increase the availability , accessibility , and cost efficacy of parent training programs , this prospect i ve r and omized trial compared a large group community-based parent training program to a clinic-based individual parent training ( PT ) programs . All families of junior kindergartners in the Hamilton public and separate school boards were sent a checklist regarding problems at home . Those returning question naires above the 90th percentile were block r and omly assigned to : ( 1 ) a 12-week clinic-based individual parent training ( Clinic/Individual ) , ( 2 ) a 12-week community-based large group parent training ( Community/Group ) , or ( 3 ) a waiting list control condition . Immigrant families , those using English as a second language , and parents of children with severe behaviour problems were significantly more likely to enroll in Community/Groups than Clinic/Individual PT . Parents in Community/Groups reported greater improvements in behaviour problems at home and better maintenance of these gains at 6-month follow-up . A cost analysis showed that , with groups of 18 families , Community/Groups are more than six times as cost effective as Clinic/Individual programs",
"Objectives : To evaluate the effectiveness and cost effectiveness of an intensive home visiting programme in improving outcomes for vulnerable families . Design : Multicentre r and omised controlled trial in which eligible women were allocated to receive home visiting ( n = 67 ) or st and ard services ( n = 64 ) . Incremental cost analysis . Setting : 40 general practitioner practice s across 2 counties in the UK . Participants : 131 vulnerable pregnant women . Intervention : Selected health visitors were trained in the Family Partnership Model to provide a weekly home visiting service from 6 months antenatally to 12 months postnatally . Main outcome measures : Mother – child interaction , maternal psychological health attitudes and behaviour , infant functioning and development , and risk of neglect or abuse . Results : At 12 months , differences favouring the home-visited group were observed on an independent assessment of maternal sensitivity ( p and infant cooperativeness ( p subject of child protection proceedings , or being removed from the home , and one death in the control group were found . The mean incremental cost per infant of the home visiting intervention was £ 3246 ( bootstrapped 95 % CI for the difference £ 1645–4803 ) . Conclusion : This intervention may have the potential to improve parenting and increase the identification of infants at risk of abuse and neglect in vulnerable families . Further investigation is needed , along with long-term follow-up to assess possible sleeper effects",
"Objective The purpose of this study was to determine if a novel workplace stress management program , delivered either face-to-face or by self-help , would reduce illness and health services utilization among participants . Methods Five hundred one volunteers were r and omly allocated to one of three groups : full intervention , which received assessment and personalized self- study feedback and was offered six face-to-face , small-group sessions ; partial intervention , a self-help group that received assessment and personalized feedback by mail ; and a wait-list control group . All participants completed question naires for stress , anxiety , and coping at the start of the study and 6 and 12 months later . Health reports were completed at 0 , 3 , 6 , 9 , and 12 months . A sub sample of subjects who subscribed to a single health maintenance organization provided objective ly recorded doctor visit data across the study year . Results All three groups reported significant improvement in their stress , anxiety , and coping across the year . Full intervention participants showed a more rapid reduction in negative responses to stress than did participants from the other groups . Full-intervention subjects also reported fewer days of illness than subjects in the other groups . Objective ly measured physician visits showed a large ( 34 % ) reduction in healthcare utilization for full intervention subjects in the HMO sub sample . Conclusions These results indicated that a work-site program that focuses on stress , anxiety , and coping measurement along with small-group educational intervention can significantly reduce illness and healthcare utilization",
"A completed series of reports on a r and omized trial ( N=400 ) indicated that , in contrast to comparison services , prenatal and infancy nurse home visitation improved a wide range of maternal and child health outcomes among poor , unmarried , and teenaged women bearing first children in a semirural county in upstate New York . Eighty-nine percent of the sample was white , and all analyses focused on this group . In this article , an analysis of the net cost of the home-visitation program from the perspective of government spending is presented . The average per-family cost of the program in 1980 dollars was $ 3,246 for the sample as a whole , and $ 3,133 for low-income families . Treatment differences in government expenditures for Aid to Families with Dependent Children , Food Stamps , Medicaid , and Child Protective Services , minus tax revenues due to maternal employment ( also expressed in 1980 dollars ) , were conceived as government savings . By the time the children were 4 years of age , government savings were $ 1,772 ( 95 % confidence interval [ CI ] : -$557 , $ 4,102 ) for the sample as a whole , and $ 3,498 ( 95 % CI : $ 569 , $ 6,427 ) for low-income families . Within 2 years after the program ended , after discounting , the net cost of the program ( program costs minus savings ) for the sample as a whole was $ 1,582 per family . For low-income families , the cost of the program was recovered with a dividend of $ 180 per family",
"Objectives : To determine whether a community-delivered intervention targeting infant sleep problems improves infant sleep and maternal well-being and to report the costs of this approach to the healthcare system . Design : Cluster r and omised trial . Setting : 49 Maternal and Child Health ( MCH ) centres ( clusters ) in Melbourne , Australia . Participants : 328 mothers reporting an infant sleep problem at 7 months recruited during October – November 2003 . Intervention : Behavioural strategies delivered over individual structured MCH consultations versus usual care . Main outcome measures : Maternal report of infant sleep problem , depression symptoms ( Edinburgh Postnatal Depression Scale ( EPDS ) ) , and SF-12 mental and physical health scores when infants were 10 and 12 months old . Costs included MCH sleep consultations , other healthcare services and intervention costs . Results : Prevalence of infant sleep problems was lower in the intervention than control group at 10 months ( 56 % vs 68 % ; adjusted OR 0.58 ( 95 % CI : 0.36 to 0.94 ) ) and 12 months ( 39 % vs 55 % ; adjusted OR 0.50 ( 0.31 to 0.80 ) ) . EPDS scores indicated less depression at 10 months ( adjusted mean difference −1.4 ( −2.3 to −0.4 ) and 12 months ( −1.7 ( −2.6 to −0.7 ) ) . SF-12 mental health scores indicated better health at 10 months ( adjusted mean difference 3.7 ( 1.5 to 5.8 ) ) and 12 months ( 3.9 ( 1.8 to 6.1 ) ) . Total mean costs including intervention design , delivery and use of non-MCH nurse services were £ 96.93 and £ 116.79 per intervention and control family , respectively . Conclusions : Implementing this sleep intervention may lead to health gains for infants and mothers and re source savings for the healthcare system . Trial registration : Current Controlled Trial Registry , number IS RCT N48752250 ( registered November 2004 )",
"BACKGROUND Home visiting programs have been developed to improve the functional abilities of older people and subsequently to reduce the use of institutional care services . The results of trials have been inconsistent and their cost-effectiveness uncertain . Home visits for a high-risk population rather than the general population seems a promising approach . We therefore studied the effects of a home visiting program for older people with poor health . This article describes the effects on health care use and associated cost . METHODS We conducted a r and omized clinical trial among 330 community-dwelling citizens , aged 70 - 84 years , in the Netherl and s. Participants in the intervention group ( n = 160 ) received eight home visits by a trained home nurse over an 18-month period ; a multidimensional geriatric assessment of problems was included . The main outcomes are : admissions to hospital , nursing home , and home for older persons ; contacts with medical specialists , general practitioners , and paramedics ; and hours of home care help . The data on health care use were mostly obtained from computerized data bases of various medical administration offices ; the follow-up period was 24 months . RESULTS Inpatient and outpatient health care use was similar for both groups , with the exception of a higher distribution of aids and in-home modifications in favor of the intervention group . No differences were found between the intervention and control group in health care cost . CONCLUSION The home visiting program did not appear to have any effect on the health care use of older people with poor health and had a low chance of being cost-effective . We conclude that these visits are probably not beneficial for such persons within the health care setting in the Netherl and s or comparable setting s in other Western countries",
"BACKGROUND Loneliness is a distressing feeling of a lack of satisfying human relationships . It is associated with poor quality of life , impaired health , and increased mortality among older individuals . The study aim was to determine the effects of new psychosocial group rehabilitation on the subjective health , use and costs of health services , and mortality of lonely older individuals . METHODS This r and omized , controlled trial was performed in seven day care centers . A total of 235 older people ( > 74 years ) suffering from loneliness participated . Intervention was implemented in 15 groups ( each with 7 - 8 participants and 2 professional group leaders ) meeting for 3 months altogether 12 times . Group intervention aim ed to empower elderly people , and to promote their peer support and social integration . Intervention was based on the effects of closed-group dynamics . The groups had the following activities according to the participants ' interests : ( a ) therapeutic writing and group psychotherapy , ( b ) group exercise and discussion s , and ( c ) art activities . Group leaders received thorough training and tutoring . Subjective health , use and costs of health services , and mortality were measured . RESULTS At 2 years , survival was 97 % in the intervention group ( 95 % confidence interval [ CI ] , 91 - 99 ) and 90 % in the control group ( 95 % CI , 85 - 95 ) ( p = .047 ) . The intervention group showed a significant improvement in subjective health , thus result ing in significantly lower health care costs during the follow-up : the difference between the groups was -943 euro/person per y ( 95 % CI -1955 to -127 ; p = .039 ) . CONCLUSIONS Psychosocial group rehabilitation was associated with lower mortality and less use of health services",
"OBJECTIVES To investigate outcomes for postnatal women attributed to special training for health visitors ( HVs ) in systematic ally identifying postnatal depression and delivering psychologically informed interventions , and to establish the cost-effectiveness of the intervention . DESIGN A pragmatic r and omised cluster trial with clusters allocated to experimental HV training arms or control , with an 18-month follow-up . SETTING GP practice s in the former Trent Regional Health Authority . PARTICIPANTS Women registered with participating GP practice s who became 36 weeks pregnant during the recruitment phase of the trial , had a live baby and were on a collaborating HV 's caseload for 4 months postnatally . INTERVENTION HV training in the assessment of postnatal women , combined with either cognitive behavioural approach ( CBA ) or person-centred approach ( PCA ) sessions for eligible women , plus the option of a selective serotonin reuptake inhibitor if indicated . MAIN OUTCOME MEASURES The primary outcome was the proportion of at-risk women with a 6-month Edinburgh Postnatal Depression Scale ( EPDS ) score > or = 12 . The primary comparison was between at-risk women in the combined clusters r and omised to HV training and women in practice s r and omised to provide HV usual care . The secondary comparison was to determine any differences between the proportions of women with a 6-month EPDS score > or = 12 in the CBA and PCA groups . RESULTS HVs in 101 clusters in 29 primary care trusts collaborated in the study . From 7649 eligible women 4084 ( 53.4 % ) consented to take part : 17.3 % ( 595/3449 ) of women who returned a 6-week question naire had a 6-week EPDS score > or = 12 and were at-risk women ; 70.3 % ( 418/595 ) of at-risk women had a 6-month EPDS score available . In total , 45.6 % ( 67/147 ) of control group ( CG ) at-risk women had a 6-month EPDS score > or = 12 versus 33.9 % ( 93/271 ) of intervention group ( IG ) women ( p = 0.036 ) . A total of 32.9 % ( 46/140 ) of at-risk women in the CBA group versus 35.1 % ( 46/131 ) in the PCA group had a 6-month EPDS score > or = 12 ( p = 0.74 ) . The CG mean 6-month EPDS score for at-risk women was 11.3 ( SD 5.8 ) versus 9.2 ( SD 5.4 ) for the IG ( p = 0.002 ) and this remained statistically significant after adjusting for 6-week variables ( p = 0.001 ) . In total , 16.4 % ( 150/914 ) of all women in the CG had a 6-month EPDS score > or = 12 compared with 11.7 % ( 205/1745 ) in the IG ( p = 0.003 ) . The CG mean 6-month EPDS score for all women was 6.4 ( SD 5.2 ) compared with 5.5 ( SD 4.7 ) for the IG ( p cost-effective at funding levels used by the National Institute for Health and Clinical Excellence . CONCLUSIONS HV training was effective compared with HV usual care in reducing the proportion of at-risk women with a 6-month EPDS score > or = 12 , with a wide confidence interval for the estimated intervention effect , suggesting that the true treatment effect may be small . The effect remained for 1 year . The economic evaluation demonstrated that the HV intervention was highly likely to be cost-effective compared with the control . There was no difference in outcomes between the CBA and the PCA groups",
"OBJECTIVES This study reports the cost-effectiveness of a preventive intervention , consisting of counseling and specific support for the mother-infant relationship , targeted at women at high risk of developing postnatal depression . METHODS A prospect i ve economic evaluation was conducted alongside a pragmatic r and omized controlled trial in which women considered at high risk of developing postnatal depression were allocated r and omly to the preventive intervention ( n = 74 ) or to routine primary care ( n = 77 ) . The primary outcome measure was the duration of postnatal depression experienced during the first 18 months postpartum . Data on health and social care use by women and their infants up to 18 months postpartum were collected , using a combination of prospect i ve diaries and face-to-face interviews , and then were combined with unit costs ( pound , year 2000 prices ) to obtain a net cost per mother-infant dyad . The nonparametric bootstrap method was used to present cost-effectiveness acceptability curves and net benefit statistics at alternative willingness to pay thresholds held by decision makers for preventing 1 month of postnatal depression . RESULTS Women in the preventive intervention group were depressed for an average of 2.21 months ( 9.57 weeks ) during the study period , whereas women in the routine primary care group were depressed for an average of 2.70 months ( 11.71 weeks ) . The mean health and social care costs were estimated at pounds sterling 2,396.9 per mother-infant dyad in the preventive intervention group and pounds sterling 2,277.5 per mother-infant dyad in the routine primary care group , providing a mean cost difference of pounds sterling 119.5 ( bootstrap 95 percent confidence interval [ CI ] , -535.4 , 784.9 ) . At a willingness to pay threshold of pounds sterling 1,000 per month of postnatal depression avoided , the probability that the preventive intervention is cost-effective is .71 and the mean net benefit is pounds sterling 383.4 ( bootstrap 95 percent CI , - pounds sterling 863.3- pounds sterling 1,581.5 ) . CONCLUSIONS The preventive intervention is likely to be cost-effective even at relatively low willingness to pay thresholds for preventing 1 month of postnatal depression during the first 18 months postpartum . Given the negative impact of postnatal depression on later child development , further research is required that investigates the longer-term cost-effectiveness of the preventive intervention in high risk women",
"BACKGROUND Antisocial behavior is enormously costly to the youth involved , their families , victims , taxpayers and other members of society . These costs are generated by school failure , delinquency and involvement in the juvenile justice system , drug use , health services and other services . For prevention programs to be cost effective , they must reduce these costly behaviors and outcomes . AIM The Fast Track intervention is a 10-year , multi-component prevention program targeting antisocial behavior . The intervention identified children at school entry and provided intervention services over a 10-year period . This study examined the intervention 's impact on outcomes affecting societal costs using data through late adolescence . METHODOLOGY The intervention is being evaluated through a multi-cohort , multi-site , multi-year r and omized control trial of program participants and comparable children and youth in similar schools , and that study provides the data for these analyses . Schools within four sites ( Durham , NC ; Nashville , TN ; Seattle , WA ; and rural central Pennsylvania ) were selected as high-risk based on crime and poverty statistics of the neighborhoods they served . Within each site , schools were divided into multiple sets matched for demographics ( size , percentage free/reduced lunch , ethnic composition ) ; one set within each pair was r and omly assigned to the intervention and one to the control condition . Within participating schools , high-risk children were identified using a multiple-gating procedure . For each of three annual cohorts , all kindergarteners ( 9,594 total ) in 54 schools were screened for classroom conduct problems by teachers . Those children scoring in the top 40 % within cohort and site were then solicited for the next stage of screening for home behavior problems by the parents , and 91 % agreed ( n = 3,274 ) . The teacher and parent screening scores were then st and ardized within site and combined into a sum score . These summed scores represented a total severity-of-risk screen score . Children were selected for inclusion into the study based on this screen score , moving from the highest score downward until desired sample sizes were reached within sites , cohorts , and conditions . RESULTS AND DISCUSSION The intervention lacked both the breadth and depth of effects on costly outcomes to demonstrate cost-effectiveness or even effectiveness . LIMITATIONS The outcomes examined here reflect effects observed during measurement windows that are not complete for every outcome . Data are lacking on some potential outcomes , such as the use of mental health services before year 7 . CONCLUSION AND IMPLICATION S The most intensive psychosocial intervention ever fielded did not produce meaningful and consistent effects on costly outcomes . The lack of effects through high school suggests that the intervention will not become cost-effective as participants progress through adulthood . FUTURE RESEARCH Future research should consider alternative approaches to prevention youth violence",
"BACKGROUND There is an urgent need for the development of cost-effective preventive strategies to reduce the onset of mental disorders . AIMS To establish the cost-effectiveness of a stepped care preventive intervention for depression and anxiety disorders in older people at high risk of these conditions , compared with routine primary care . METHOD An economic evaluation was conducted alongside a pragmatic r and omised controlled trial ( IS RCT N26474556 ) . Consenting individuals presenting with subthreshold levels of depressive or anxiety symptoms were r and omly assigned to a preventive stepped care programme ( n = 86 ) or to routine primary care ( n = 84 ) . RESULTS The intervention was successful in halving the incidence rate of depression and anxiety at euro563 ( pound412 ) per recipient and euro4367 ( pound3196 ) per disorder-free year gained , compared with routine primary care . The latter would represent good value for money if the willingness to pay for a disorder-free year is at least euro5000 . CONCLUSIONS The prevention programme generated depression- and anxiety-free survival years in the older population at affordable cost",
"OBJECTIVES To determine whether increased postnatal support could influence maternal and child health outcomes . DESIGN This was a r and omised controlled trial comparing maternal and child health outcomes for women offered either of the support interventions with those for control women receiving st and ard services only . Outcome data were collected through question naires distributed 12 and 18 months postr and omisation . Process data were also collected . There was also an integral economic evaluation . SETTING AND PARTICIPANTS Women living in deprived enumeration districts in selected London boroughs were eligible for the trial if they gave birth between 1 January and 30 September 1999 . RESULTS The 731 participants were found to be well matched in terms of socio-economic characteristics and health and support variables ( 14 % of the participants were non-English speaking ) . Response rates at the two follow-up points were 90 % and 82 % . At both points there were no differences that could not be attributed to chance on the primary outcomes of maternal depression , child injury or maternal smoking . At the first follow-up , there was reduced use of general practitioners by support health visitor ( SHV ) children , but increased use of NHS health visitors and social workers by mothers . At the second follow-up , both community group support ( CGS ) and SHV mothers had less use of midwifery services ( fewer were pregnant ) , and SHV mothers were less worried about their child 's health and development . Uptake of the CGS intervention was low : 19 % , compared with 94 % for the SHV intervention . Satisfaction with the intervention among women in the SHV group was high . Based on the assumptions and conditions of the costing methods , the economic evaluation found no net economic cost or benefit of choosing either of the two interventions . CONCLUSIONS There was no evidence of impact on the primary outcomes of either intervention . The SHV intervention was popular with women , and was associated with improvement in some of the secondary outcomes . This suggests that greater emphasis on the social support role of health visitors could improve some measures of family well-being . Possible areas for future research include a systematic review of social support and its effect on health ; developing and testing other postnatal models of support that match more closely the age of the baby and the changing patterns of mothers ' needs ; evaluating other strategies for mobilising ' non-professional ' support ; developing and testing more culturally specific support interventions ; developing more culturally appropriate st and ardised measures of health outcomes ; providing longer term follow-up of social support interventions ; and exploring the role of social support on the delay in subsequent pregnancy",
"OBJECTIVES This study examined whether interventions aim ed at aggressive/disruptive classroom behavior and poor academic achievement would reduce the incidence of initiation of smoking . METHODS An epidemiologically based , universal r and omized preventive trial involved 2311 children in 2 classroom-based preventive interventions or controls . Each intervention was directed at 1 of the aforementioned 2 antecedents over first and second grade s in 19 urban schools . RESULTS Smoking initiation was reduced in both cohorts for boys assigned to the behavioral intervention . CONCLUSIONS Targeting early risk antecedents such as aggressive behavior appears to be an important smoking prevention strategy",
"AIM This paper reports a study evaluating the comparative effects and costs of a proactive nursing health promotion intervention in addition to usual home care for older people compared with usual home care services alone . BACKGROUND An ageing population , budget constraints and technological advances in many countries have increased the pressure on home care re sources . The result is a shift in nursing services from health promotion to meet the more pressing need for postacute care . For frail older people with long-term needs , these changes combine to create a fragmented system of health service delivery , characterized by providing nursing on dem and rather than proactively . METHODS A two-armed , single-blind , r and omized controlled trial was carried out with older people > or = 75 years and eligible for personal support services through a home care programme in Ontario , Canada . Participants were r and omly allocated either to usual home care ( control ) or to a nursing ( experimental ) group . In addition to usual home care , the nursing group received a health assessment combined with regular home visits or telephone contacts , health education about management of illness , coordination of community services , and use of empowerment strategies to enhance independence . The data were collected in 2001 - 2002 . RESULTS Of the 288 older people who were r and omly allocated at baseline , 242 ( 84 % ) completed the study ( 120 nursing group ; 122 control group ) . Proactively providing older people with nursing health promotion , compared with providing nursing services on-dem and , result ed in better mental health functioning ( P = 0.009 ) , a reduction in depression ( P = 0.009 ) , and enhanced perceptions of social support ( P = 0.009 ) at no additional cost from a societal perspective . CONCLUSIONS Home based nursing health promotion , proactively provided to frail older people with chronic health needs , enhances quality of life while not increasing the overall costs of health care . The results underscore the need to re-invest in nursing services for health promotion for older clients receiving home care ",
"BACKGROUND Recent review s have shown that home visiting programmes that address parenting have the potential to improve long term health and social outcomes for children . However there are few studies exploring the cost-effectiveness of such interventions . The objective of this study was to evaluate the cost-effectiveness of an intensive home visiting programme directed at vulnerable families during the antenatal and postnatal periods . METHODS The design was an economic evaluation alongside a multicentre r and omized controlled trial , in which 131 eligible women were r and omly allocated to receive 18 months of intensive home visiting ( n=67 ) or st and ard services ( n=64 ) . Due to the public health nature of the intervention a cost-effectiveness analysis was undertaken from a societal perspective . RESULTS The mean ' societal costs ' in the control and intervention arms were 3874 pounds and 7120 pounds , respectively , a difference of 3246 pounds ( p mean ' health service only ' costs were 3324 pounds and 5685 pounds respectively , a difference of 2361 pounds ( p maternal sensitivity and infant cooperativeness there was also a non-significant increase in the likelihood of the intervention group infants being removed from the home due to abuse and neglect . These incremental benefits were delivered at an incremental societal cost of 3246 pounds per woman . CONCLUSIONS The results of the study provide evidence to suggest that , within the context of regular home visits , specially trained home visitors can increase maternal sensitivity and infant cooperativeness and are better able to identify infants in need of removal from the home for child protection . The extent to which these benefits are ' worth ' the societal cost of 3246 pounds per woman however is a matter of judgment",
"OBJECTIVES To determine whether a social support intervention ( access to an employed befriending facilitator in addition to usual care ) is effective compared with usual care alone . Also to document direct and indirect costs , and establish incremental cost-effectiveness . DESIGN The Befriending and Costs of Caring ( BECCA ) trial was a cost-effectiveness r and omised controlled trial . Data on well-being and re source use were collected through interviews with participants at baseline and at 6 , 15 and 24 months . SETTING This research was carried out in the English counties of Norfolk and Suffolk , and the London Borough of Havering . It was a community-based study . PARTICIPANTS Participants were family carers who were cohabiting with , or providing at least 20 hours ' care per week for , a community-dwelling relative with a primary progressive dementia . INTERVENTIONS The intervention was ' access to a befriender facilitator ' ( BF ) . BFs , based with charitable/voluntary-sector organisations , were responsible for local befriending schemes , including recruitment , screening , training and ongoing support of befriending volunteers , and for matching carers with befrienders . The role of befrienders was to provide emotional support for carers . The target duration for befriending relationships was 6 months or more . MAIN OUTCOME MEASURES Depression was measured by the Hospital Anxiety and Depression Scale ( HADS ) at 15 months postr and omisation . The health-related quality of life scale EQ-5D ( EuroQol 5 Dimensions ) was used to derive utilities for the calculation of quality -adjusted life-years ( QALYs ) . RESULTS A total of 236 carers were r and omised into the trial ( 116 intervention ; 120 control ) . At final follow-up , 190 carers ( 93 intervention ; 97 control ) were still involved in the trial ( 19 % attrition ) . There was no evidence of effectiveness or cost-effectiveness from the primary analyses on the intention-to-treat population . The mean incremental cost per incremental QALY gained was in excess of 100,000 pounds , with only a 42.2 % probability of being below 30,000 pounds per QALY gained . Where care-recipient QALYs were included , mean incremental cost per incremental QALY gained was 26,848 pounds , with a 51.4 % probability of being below 30,000 pounds per QALY gained . Only 60 carers ( 52 % ) took up the offer of being matched with a trained lay befriender , and of these only 37 ( 32 % ) were befriended for 6 months or more . A subgroup analysis of controls versus those befriended for 6 months or more found a reduction in HADS-depression scores that approached statistical significance ( 95 % CI -0.09 to 2.84 ) . CONCLUSIONS ' Access to a befriender facilitator ' is neither an effective nor a cost-effective intervention in the support of carers of people with dementia , although there is a suggestion of cost-effectiveness for the care dyad ( carer and care recipient ) . In common with many services for carers of people with dementia , uptake of befriending services was not high . However , the small number of carers who engaged with befrienders for 6 months or more reported a reduction in scores on HADS depression that approached statistical significance compared with controls ( 95 % CI -0.09 to 2.84 ) . While providing only weak evidence of any beneficial effect , further research into befriending interventions for carers is warranted",
"Objectives The aim of the study was to evaluate the effectiveness of two brief preventive stress reduction programs — a cognitive focused program and a combined intervention of physical exercise and relaxation — on sickness absence in stressed and non-stressed employees working in various jobs in a telecom company . Methods The study was design ed as an a priori r and omized trial and the follow-up period for sickness absence was 1 year . Sickness absence data of 242 employees were analyzed with respect to spells of sickness ( frequency , incidence rate ) , days ( length , duration ) and time between intervention and first subsequent absent spell . Results For stressed employees this study suggests that the illness burden represented by absenteeism is not affected by the interventions . There is no substantial difference in effectiveness between the cognitive and physical interventions . However , in comparison with the physical intervention the cognitive intervention decreases the period between the intervention and the first recurrence of a sick leave period with 144 days ( marginal significant ) . Conclusion The illness burden represented by absenteeism is effected in detail but not substantially by the interventions",
"BACKGROUND Infant attachment security is a protective factor for future mental health , and may be promoted by individual interventions . Given service dem and s , it is important to determine if a group-based intervention for parents could be used to enhance infant attachment security . METHODS In a r and omized trial involving 76 mothers , an 8-session attachment group called ' Right from the Start ' ( RFTS ) was compared to home visiting ( treatment as usual ) . RESULTS Intention-to-treat analyses indicated no significant differences between RFTS and home visiting , with both groups showing small improvements in infant attachment security and maternal sensitivity . RFTS cost significantly less and was more cost effective than home visiting , and was not significantly different in terms of participation ratings , client satisfaction , or follow-up service requests . There was differential compliance for the two interventions , with 89 % and 58 % attending 4 or more sessions of home visiting and RFTS , respectively . Secondary analyses considering non-attenders as a separate ( nonr and omized ) group indicated a significant advantage for those who attended RFTS on pre-test/post-test maternal sensitivity change scores ( d = .52 ) and pre-test/6-month follow-up infant attachment security changes scores ( d = .55 ) . CONCLUSIONS RFTS is as effective as home visiting in improving infant attachment security and maternal sensitivity . The effect sizes for RFTS were comparable to those of individual attachment interventions in this relatively inexpensive , community-based group intervention"
] | 41163eae-06ff-11f0-808a-c43d1ab1c353 |
Objective : Pharmacological treatment is considered indispensable to major depressive disorder . In spite of this , a significant number of patients do not respond adequately to treatment based only on medication , presenting high relapse and recurrence rates . Therefore , psychosocial interventions , such as psychoeducation , have been increasingly recognized as an essential component in the treatment of depression , associated with pharmacological strategies . Thus , the aim of the present systematic review was to evaluate the effectiveness of psychoeducation for patients with unipolar depression , analyzing the evidence from the literature . Method : Search es were undertaken from April to October 2012 in LILACS , PsycINFO , PubMed , SCOPUS and ISI Web of Knowledge with keywords including ‘ psychoeducation ’ , ‘ psychoeducational intervention ’ and ‘ depression ’ , with no restriction regarding publishing date s. Results : Fifteen studies were included in the review , 13 of which evaluated the effectiveness of psychoeducation for patients with depression : 10 papers evaluated in-person psychoeducation approaches and three papers evaluated long-distance approaches . In addition to these 13 papers , one evaluated psychoeducational interventions for patients ’ families and patients ’ responses and another evaluated psychoeducational interventions for patients ’ families and families ’ responses . Findings suggest that increased knowledge about depression and its treatment is associated with better prognosis in depression , as well as with the reduction of the psychosocial burden for the family . Conclusions : Psychoeducation is a psychosocial treatment that has been well documented as an adjunct to pharmacological therapy . However , there are only a few studies regarding its effectiveness on adult patients with major depressive disorder . Although the publications in this area are still very limited , the articles selected in this review suggest that psychoeducation is effective in improving the clinical course , treatment adherence , and psychosocial functioning of depressive patients | [
"BACKGROUND Depression is associated with immense suffering and costs , and many patients receive inadequate care , often because of the limited availability of treatment . Web-based treatments may play an increasingly important role in closing this gap between dem and and supply . We developed the integrative , Web-based program Deprexis , which covers therapeutic approaches such as behavioral activation , cognitive restructuring , mindfulness/acceptance exercises , and social skills training . OBJECTIVE To evaluate the effectiveness of the Web-based intervention in a r and omized controlled trial . METHODS There were 396 adults recruited via Internet depression forums in Germany , and they were r and omly assigned in an 80:20 weighted r and omization sequence to either 9 weeks of immediate-program-access as an add-on to treatment-as-usual ( N = 320 ) , or to a 9-week delayed-access plus treatment-as-usual condition ( N = 76 ) . At pre- and post-treatment and 6-month follow-up , we measured depression ( Beck Depression Inventory ) as the primary outcome measure and social functioning ( Work and Social Adjustment Scale ) as the secondary outcome measure . Complete analyses and intention-to-treat analyses were performed . RESULTS Of 396 participants , 216 ( 55 % ) completed the post-measurement 9 weeks later . Available case analyses revealed a significant reduction in depression severity ( BDI ) , Cohen 's d = .64 ( CI 95 % = 0.33 - 0.94 ) , and significant improvement in social functioning ( WSA ) , Cohen 's d = .64 , 95 % ( CI 95 % = 0.33 - 0.95 ) . These improvements were maintained at 6-month follow-up . Intention-to-treat analyses confirmed significant effects on depression and social functioning improvements ( BDI : Cohen 's d = .30 , CI 95 % = 0.05 - 0.55 ; WSA : Cohen 's d = .36 , CI 95 % = 0.10 - 0.61 ) . Moreover , a much higher percentage of patients in the intervention group experienced a significant reduction of depression symptoms ( BDI : odds ratio [ OR ] = 6.8 , CI 95 % = 2.90 - 18.19 ) and recovered more often ( OR = 17.3 , 95 % CI 2.3 - 130 ) . More than 80 % of the users felt subjectively that the program had been helpful . CONCLUSIONS This integrative , Web-based intervention was effective in reducing symptoms of depression and in improving social functioning . Findings suggest that the program could serve as an adjunctive or st and -alone treatment tool for patients suffering from symptoms of depression",
"Objective This report evaluates the effects of a depression relapse prevention program on disability outcomes among patients treated for depression at high risk for relapse . Material s and Methods Primary care patients initiating antidepressant treatment for depression were assessed 6 to 8 weeks after the initial prescription . Patients responding to initial treatment but at high risk for relapse were r and omized to usual care or a relapse prevention intervention ( N = 386 ) . The 12-month relapse prevention program included systematic patient education , two psycho-educational visits with a depression prevention specialist , shared decision-making regarding maintenance pharmacotherapy , and ongoing monitoring of medication adherence and depressive symptoms via telephone and mail . Disability outcomes were assessed via blinded telephone assessment s at 3 , 6 , 9 , and 12 months using SF-36 and Sheehan Disability scales . Results Usual care patients and relapse prevention program patients had high rates of use of maintenance pharmacotherapy . Both relapse prevention and usual care patients showed improved functioning over the 12-month follow-up period . One of the three disability measures ( the SF-36 Social Function scale ) showed a significant intervention effect because of continuing improvement at 9 and 12 month follow-up , whereas the Sheehan Disability Scale showed a nonsignificant trend toward greater improvements in disability among relapse prevention patients than among usual care controls . Conclusions Moderate effects of a relapse prevention intervention on depressive symptoms were associated with modest and variable effects on disability outcomes . Inconsistent effects of the intervention for disability outcomes may be because of the high rates of maintenance pharmacotherapy among usual care patients , relatively mild levels of depressive symptoms among both intervention and control patients at baseline , the absence of a specific relapse prevention effect of the intervention , and the result ant modest differences in depressive symptoms between intervention and control patients in this trial",
"Family psychoeducational programs are efficacious adjuncts to pharmacotherapy for patients with schizophrenic and bipolar disorders , but little is known about what these programs change about families . The authors assessed changes in face-to-face interactional behavior over 1 year among families of bipolar patients who received a 9-month family-focused psychoeducational therapy ( FFT ; n = 22 ) or crisis management with naturalistic follow-up ( CMNF ; n = 22 ) , both administered with maintenance pharmacotherapy . Members of families who received FFT showed more positive nonverbal interactional behavior during a 1-year posttreatment problem-solving assessment than families who received CMNF , although no corresponding decreases were seen in negative interactional behaviors . The positive effect of family treatment on patients ' symptom trajectories over 1 year was partially mediated by increases in patients ' positive nonverbal interactional behaviors during this same interval",
"This clinical project compares the relative impact of two types of multiple family groups on psychiatric in patients and their families . Forty patients with a diagnosis of affective disorder , and their family members , were r and omly assigned to a traditional multiple family group with a process orientation that emphasized support , destigmatization , and self-help about common problems ; or to a psychoeducational multiple family group that emphasized the provision of information about the patient 's illness and methods of coping with it effectively . Both groups , which met for four hours on a Saturday afternoon , were an integral part of an ongoing inpatient program specializing in the treatment of affective disorders . Pre- and post- measures were obtained regarding family and patient knowledge about affective disorders , level of personal distress , attitudes about the illness , and dyadic adjustment . In addition , both patients and family members were asked to rate their satisfaction with the group experience . A number of differences in knowledge , attitude and dyadic adjustment were found in the participants of both groups immediately following their respective group sessions , but there were only a few statistically significant differences between the two groups . Those who attended the psychoeducational session , however , reported significantly more satisfaction with the experience",
"BACKGROUND Depression is a remitting but recurring disease . However , there is a paucity of prospect ively recorded data on the course of depression after recovery . METHOD A multi-centre prospect i ve serial follow-up study of an inception cohort of hitherto untreated unipolar major depression ( N = 95 ) for 6 years . We report the time to recurrence after recovery from the index depressive episode and their predictors . RESULTS The cumulative probability of remaining well without subthreshold symptoms was 57 % ( 95 % CI , 46 to 68 % ) at 1 year , 47 % ( 95 % CI , 36 to 58 % ) at 2 years and 35 % ( 95 % CI , 23 to 47 % ) at 5 years . The same without full relapse was 79 % ( 95 % CI , 70 to 88 % ) at 1 year , 70 % ( 95 % CI , 60 to 80 % ) at 2 years and 58 % ( 95 % CI , 46 to 70 % ) at 5 years . The median duration of well-interval from the end of the index episode to the beginning of the subthreshold episode was 19 - 0 months ( 95 % CI , 2 - 4 to 35 - 7 ) , and that to the end of the full episode was over 6 years . Residual symptoms at time of recovery predicted earlier recurrence . CONCLUSIONS The median length of the well-interval was much longer than previously reported in studies employing similar definitions but dealing with a more severe spectrum of patients . However , the sobering fact remains that less than half of the patients can expect to remain virtually symptom-free for 2 years or more after recovery from the depressive episode",
"The relative benefit of adding a structured psychoeducational intervention to st and ard medication treatment for married patients with bipolar disorder and their spouses was assessed . Patients were r and omly assigned to receive either medication management or medication management plus a marital intervention with their spouses for an 11-month period . Patients ' symptoms , functioning , and adherence to their medication regimens were measured at study entry and at 11 months . Significant effects favoring the combined treatments were observed for overall patient functioning but not for symptom levels . The marital intervention was associated with improved medication adherence . Combined psychosocial and medication treatment does not affect patients ' symptom levels beyond the effects of medication alone , but it does result in significant incremental gains in overall patient functioning",
"Abstract Objective To evaluate the efficacy of two internet interventions for community-dwelling individuals with symptoms of depression — a psychoeducation website offering information about depression and an interactive website offering cognitive behaviour therapy . Design R and omised controlled trial . Setting Internet users in the community , in Canberra , Australia . Participants 525 individuals with increased depressive symptoms recruited by survey and r and omly allocated to a website offering information about depression ( n = 166 ) or a cognitive behaviour therapy website ( n = 182 ) , or a control intervention using an attention placebo ( n = 178 ) . Main outcome measures Change in depression , dysfunctional thoughts ; knowledge of medical , psychological , and lifestyle treatments ; and knowledge of cognitive behaviour therapy . Results Intention to treat analyses indicated that information about depression and interventions that used cognitive behaviour therapy and were delivered via the internet were more effective than a credible control intervention in reducing symptoms of depression in a community sample . For the intervention that delivered cognitive behaviour therapy the reduction in score on the depression scale of the Center for Epidemiologic Studies was 3.2 ( 95 % confidence interval 0.9 to 5.4 ) . For the “ depression literacy ” site ( BluePages ) , the reduction was 3.0 ( 95 % confidence interval 0.6 to 5.2 ) . Cognitive behaviour therapy ( MoodGYM ) reduced dysfunctional thinking and increased knowledge of cognitive behaviour therapy . Depression literacy ( BluePages ) significantly improved participants ' underst and ing of effective evidence based treatments for depression ( P cognitive behaviour therapy and psychoeducation delivered via the internet are effective in reducing symptoms of depression",
"Background Coping with Depression Course ( CWD ) has shown to be effective in the treatment of depression . However , there are very few r and omized controlled trials on unipolar depression in adults Aims To test the effect of a modified CWD on unipolar depression in a r and omized controlled trial design in adults . Methods Participants were recruited through mass media , tested by BDI and clinical interview , and r and omized into intervention group ( N = 81 ) and control group ( N = 74 ) . The program was mainly conducted by nurses with background in psychiatry and primary health care , and the intervention encompassed 8 weekly sessions of 2 1/2 hours , with 3 booster sessions . Results By \" intention-to-treat \" analysis a statistically significant effect on depressive symptoms at follow up at 6 months was found , and the level of symptoms was sustained after 12 months . Conclusion The study shows that the intervention is effective in the treatment of unipolar depression , and suitable for specialized psychiatric services as well as primary health care",
"In a waiting-list controlled study on a multi-family psycho-educational intervention in bipolar disorder , key relatives in the treatment group showed a significant change from high to low levels of expressed emotion ( EE ) compared with the control group . In addition , patients with low-EE key relatives had a significantly lower number of hospital admissions compared with those living with high-EE key relatives . The multi-family groups were well received by the participants , and there were only a few drop-outs",
"Objective . Evaluate the incremental cost-effectiveness of a depression relapse prevention program in primary care Material s and Methods . Primary care patients initiating antidepressant treatment completed a st and ardized telephone assessment 6–8 weeks later . Those recovered from the current episode but at high risk for relapse ( based on history of recurrent depression or dysthymia ) were offered r and omization to usual care or a relapse prevention intervention . The intervention included systematic patient education , two psychoeducational visits with a depression prevention specialist , shared decision-making regarding maintenance pharmacotherapy , and telephone and mail monitoring of medication adherence and depressive symptoms . Outcomes in both groups were assessed via blinded telephone assessment s at 3 , 6 , 9 , and 12 months and health plan cl aims and accounting data . Results . Intervention patients experienced 13.9 additional depression-free days during a 12-month period ( 95 % CI , −1.5 to 29.3 ) . Incremental costs of the intervention were $ 273 ( 95 % CI , $ 102 to $ 418 ) for depression treatment costs only and $ 160 ( 95 % CI , −$173 to $ 512 ) for total outpatient costs . Incremental cost-effectiveness ratio was $ 24 per depression-free day ( 95 % CI , −$59 to $ 496 ) for depression treatment costs only and $ 14 per depression-free day ( 95 % CI , −$35 to $ 248 ) for total outpatient costs . Conclusions . A program to prevent depression relapse in primary care yields modest increases in days free of depression and modest increases in treatment costs . These modest differences reflect high rates of treatment in usual care . Along with other recent studies , these findings suggest that improved care of depression in primary care is a prudent investment of health care re sources",
"Abstract Objectives : To determine the acceptability of two psychological interventions for depressed adults in the community and their effect on caseness , symptoms , and subjective function . Design : A pragmatic multicentre r and omised controlled trial , stratified by centre . Setting : Nine urban and rural communities in Finl and , Republic of Irel and , Norway , Spain , and the United Kingdom . Participants : 452 participants aged 18 to 65 , identified through a community survey with depressive or adjustment disorders according to the international classification of diseases , 10th revision or Diagnostic and Statistical Manual of Mental Disorders , fourth edition . Interventions : Six individual sessions of problem solving treatment ( n=128 ) , eight group sessions of the course on prevention of depression ( n=108 ) , and controls ( n=189 ) . Main outcome measures : Completion rates for each intervention , diagnosis of depression , and depressive symptoms and subjective function . Results : 63 % of participants assigned to problem solving and 44 % assigned to prevention of depression completed their intervention . The proportion of problem solving participants depressed at six months was 17 % less than that for controls , giving a number needed to treat of 6 ; the mean difference in Beck depression inventory score was −2.63 ( 95 % confidence interval −4.95 to −0.32 ) , and there were significant improvements in SF-36 scores . For depression prevention , the difference in proportions of depressed participants was 14 % ( number needed to treat of 7 ) ; the mean difference in Beck depression inventory score was −1.50 ( −4.16 to 1.17 ) , and there were significant improvements in SF-36 scores . Such differences were not observed at 12 months . Neither specific diagnosis nor treatment with antidepressants affected outcome . Conclusions : When offered to adults with depressive disorders in the community , problem solving treatment was more acceptable than the course on prevention of depression . Both interventions reduced caseness and improved subjective function",
"BACKGROUND Failure to respond to antidepressant medication represents a major clinical problem . Few therapeutic interventions have been shown to benefit such individuals . METHOD Patients attended a 12-session psychoeducational programme over a period of 10 weeks , with follow-up at 26 weeks . The main outcome measures were the self-report Beck Depression Inventory ( BDI-II ) , the Global Severity Index ( GSI ) of the Brief Symptom Inventory ( BSI ) and the EuroQol 5D . RESULTS Baseline assessment s confirmed substantial chronicity and treatment resistance , high symptom burden and poor quality of life in the study cohort . Twenty-six week follow-up data were obtained from 34 % of cohort . Completion of the course was associated with clinical ly significant changes in symptom burden . Sustained remission was achieved by 35 % of completers . LIMITATIONS We did not characterise the cohort using structured clinical interview and did not collect structured , objective ratings of mental health status . There was no control group . There was a high attrition rate and caution must be exercised in interpreting results . CONCLUSIONS For a proportion of patients with chronic depressive episodes that have not responded to antidepressant treatments , the \" Coping with Depression \" psychoeducational group may confer sustained and meaningful benefit . Controlled studies are warranted",
"The benefit of single-family treatment ( SFT ) in addition to short educational sessions ( SES ) consisting of multiple-family treatment was investigated . The study design was a r and omized controlled study . Subjects were 30 patients suffering from schizophrenia with at least one of their family members showing high expressed emotion ( EE ) in the Camberwell Family Interview . After the SES , the patients were r and omly allocated to two groups : those who received routine individual outpatient treatment and those who received additional SFT and routine treatment . The two groups were followed for 9 months after discharge , and the relapse risks were compared . The relapse risk was lower in the SES+SFT group than in the SES group ( 23.1 % vs. 35.3 % ) . However , the difference was not significant . When high-EE families were classified into those with many critical comments ( high-CC ) or a high score of emotional overinvolvement ( high-EOI ) , the relapse risk was 0 % in the patients living with a high-CC family not only in the SES+SFT group but also in SES group . In the patients living with a high-EOI family , the relapse risk was lower in the SES+SFT group than in the SES group ( 42.9 % vs. 60.0 % ) . These findings suggest that high-EE families should receive at least SES , and additional SFT should be given to families with specific needs",
"This study examined the efficacy of a psychoeducational approach in treating unipolar depression . The vehicle of treatment was a course in \" Coping with Depression . \" An explicit educational experience , the course addressed several specific target behaviors ( social skills , thinking , pleasant activities , and relaxation ) as well as more general components hypothesized to be critical to successful cognitive-behavioral therapy for depression . Sixty-three individuals who met Research Diagnostic Criteria ( RDC ) for unipolar depression were r and omly assigned to one of four conditions : class , individual tutoring , minimal contact , or delayed treatment control . Participants in the immediate treatment conditions were assessed pre- and posttreatment and at 1- and 6-month follow-up sessions ; the delayed treatment group was assessed prior to and following an 8-week waiting period . Results indicated clinical improvement by all of the active treatment conditions compared to the delayed treatment condition . Differences between active treatment conditions were small , and some differences between high and low responders to treatment were found . Results are discussed in terms of their implication s for future clinical use of this approach . Stimulated by recent theoretical developments , there has been an impressive proliferation of interventions and approaches for the psychological treatment of unipolar depression . Treatments derived from cognitive positions have been aim ed at depressive thought processes ( e.g. , Beck , Rush , Shaw , & Emery , 1979 ; Fuchs & Rehm , 1977 ) , whereas those derived from behavioral positions have been aim ed at the improvement of social skills ( Hersen , Bellack , & Himmelhoch , 1980 ; Sanchez , Lewinsohn , & Larson , 1980 ; Zeiss , 1977 ) , at increasing pleasant activities and time management relaxation skills ( Lewinsohn , 1977 ) , and at more general problemsolving skills ( McLean & Hakstian , 1979 ) .",
"BACKGROUND Despite high rates of relapse and recurrence , few primary care patients with recurrent or chronic depression are receiving continuation and maintenance-phase treatment . We hypothesized that a relapse prevention intervention would improve adherence to antidepressant medication and improve depression outcomes in high-risk patients compared with usual primary care . METHODS Three hundred eighty-six patients with recurrent major depression or dysthymia who had largely recovered after 8 weeks of antidepressant treatment by their primary care physicians were r and omized to a relapse prevention program ( n = 194 ) or usual primary care ( n = 192 ) . Patients in the intervention group received 2 primary care visits with a depression specialist and 3 telephone visits over a 1-year period aim ed at enhancing adherence to antidepressant medication , recognition of prodromal symptoms , monitoring of symptoms , and development of a written relapse prevention plan . Follow-up assessment s were completed at 3 , 6 , 9 , and 12 months by a telephone survey team blinded to r and omization status . RESULTS Those in the intervention group had significantly greater adherence to adequate dosage of antidepressant medication for 90 days or more within the first and second 6-month periods and were significantly more likely to refill medication prescriptions during the 12-month follow-up compared with usual care controls . Intervention patients had significantly fewer depressive symptoms , but not fewer episodes of relapse/recurrence over the 12-month follow-up period . CONCLUSIONS A relapse prevention program targeted to primary care patients with a high risk of relapse/recurrence who had largely recovered after antidepressant treatment significantly improved antidepressant adherence and depressive symptom outcomes",
"BACKGROUND Studies on individual psychotherapy indicate that some interventions may reduce the number of recurrences in bipolar patients . However , there has been a lack of structured , well- design ed , blinded , controlled studies demonstrating the efficacy of group psychoeducation to prevent recurrences in patients with bipolar I and II disorder . METHODS One hundred twenty bipolar I and II out patients in remission ( Young Mania Rating Scale score st and ard pharmacologic treatment , were included in a controlled trial . Subjects were matched for age and sex and r and omized to receive , in addition to st and ard psychiatric care , 21 sessions of group psychoeducation or 21 sessions of nonstructured group meetings . Subjects were assessed monthly during the 21-week treatment period and throughout the 2-year follow-up . RESULTS Group psychoeducation significantly reduced the number of relapsed patients and the number of recurrences per patient , and increased the time to depressive , manic , hypomanic , and mixed recurrences . The number and length of hospitalizations per patient were also lower in patients who received psychoeducation . CONCLUSION Group psychoeducation is an efficacious intervention to prevent recurrence in pharmacologically treated patients with bipolar I and II disorder",
"This r and omized pilot study investigated the effects of meditation with yoga ( and psychoeducation ) versus group therapy with hypnosis ( and psychoeducation ) versus psychoeducation alone on diagnostic status and symptom levels among 46 individuals with long-term depressive disorders . Results indicate that significantly more meditation group participants experienced a remission than did controls at 9-month follow-up . Eight hypnosis group participants also experienced a remission , but the difference from controls was not statistically significant . Three control participants , but no meditation or hypnosis participants , developed a new depressive episode during the study , though this difference did not reach statistical significance in any case . Although all groups reported some reduction in symptom levels , they did not differ significantly in that outcome . Overall , these results suggest that these two interventions show promise for treating low- to moderate-level depression"
] | 41163eea-06ff-11f0-808a-c43d1ab1c353 |
Objective : To determine in a systematic review , whether interventions for infant development that involve parents , improve neurodevelopment at 12 months corrected age or older . Study Design : R and omized trials were identified where an infant intervention was aim ed to improve development and involved parents of preterms ; and long-term neurodevelopment using st and ardized tests at 12 months ( or longer ) was reported . Result : Identified studies ( n=25 ) used a variety of interventions including parent education , infant stimulation , home visits or individualized developmental care . Meta- analysis at 12 months ( N=2198 infants ) found significantly higher mental ( N=2198 ) and physical ( N=1319 ) performance scores favoring the intervention group . At 24 months , the mental ( N=1490 ) performance scores were improved , but physical ( N=1025 ) performance scores were not statistically significant . The improvement in neurodevelopmental outcome was not sustained at 36 months ( N=961 ) and 5 years ( N=1017 ) . Conclusion : Positive clinical ly meaningful effects ( > 5 points ) are seen to an age of 36 months , but are no longer present at 5 years | [
"Background . Based on the general bonding hypothesis , it is suggested that kangaroo mother care ( KMC ) creates a climate in the family whereby parents become prone to sensitive caregiving . The general hypothesis is that skin-to-skin contact in the KMC group will build up a positive perception in the mothers and a state of readiness to detect and respond to infant 's cues . Method . The r and omized controlled trial was conducted on a set of 488 infants weighing KMC group and 242 in the traditional care ( TC ) group . The design allows precise observation of the timing and duration of mother – infant contact , and takes into account the infant 's health status at birth and the socioeconomic status of the parents . Bonding Assessment . Two series of outcomes are assessed as manifestations of a mother 's attachment behavior . The first is the mother 's feelings and perceptions of her premature birth experience , including her sense of competence , feelings of worry and stress , and perception of social support . The second outcome is derived from observations of the mother and child 's responsivity to each other during breastfeeding at 41 weeks of gestational age . Interventions . KMC has three components . The first is the kangaroo position . Once the premature infant has adapted to extrauterine life and is able to breastfeed , he is positioned on the mother 's chest , in a upright position , with direct skin-to-skin contact . The second component is kangaroo nutrition . Although breastfeeding is the prime source of nutrition , infants also may receive preterm formula whenever necessary and vitamin supplements . The third component is the clinical control ; infants are monitored on a regular basis , daily until they are gaining at least 20 g per day . Afterward , weekly clinic visits are scheduled until term , which constitutes the ambulatory minimal neonatal care . In the TC group , infants are kept in incubators until they are able to self-regulate their temperature and are thriving ( ie , have an appropriate weight gain ) . Infants are discharged according to current hospital practice , usually not before their weight is ∼1700 g. Afterward , as with the KMC group , weekly clinic visits are scheduled until term . Results . We observed a change in the mothers ' perception of her child , attributable to the skin-to-skin contact in the kangaroo-carrying position . This effect is related to a subjective “ bonding effect ” that may be understood readily by the empowering nature of the KMC intervention . Moreover , in stressful situations when the infant has to remain in the hospital longer , mothers practicing KMC feel more competent than do mothers in the TC group . This is what we call a resilience effect . In these stressful situations we also found a negative effect on the feelings of received support of mothers practicing KMC . We interpret this as an isolation effect . To thwart this deleterious effect , we would suggest adding social support as an integral component of KMC . The observations of the mothers ' sensitive behavior did not show a definite bonding effect , but rather a resilience effect . This is attributable to the KMC intervention ; mothers practicing KMC were more responsive to an at-risk infant whose development has been threatened by a longer hospital stay . Otherwise , we observed that the mothers ( in both the KMC group and the TC group ) had behavioral patterns that were adapted to the child 's at-risk health status and to the precarious condition of some premature infants requiring intensive care . We conclude that the infant 's health status may be a more prominent factor in explaining a mother 's more sensitive behavior , which overshadows the kangaroo-carrying effect . Conclusion . These results suggest that KMC should be promoted actively and that mothers should be encouraged to use it as soon as possible during the intensive care period up to the 40 weeks of gestational age . Thus , KMC should be viewed as a means of humanizing the process of giving birth in a context of prematurity . This finding confirms the conclusions of the 1996 Trieste workshop suggesting that KMC should be promoted both in hospitals and after early discharge",
"Abstract This study aims at assessing the effects of an early occupational therapy intervention on the cognitive development and the development of attachment patterns in ELBW infants . The intervention , given weekly at home from six months to 12 months , aim ed at supporting parent-child interaction and enhancing motor control and coordination . The study population consisted of 100 ELBW infants matched in pairs in accordance to their pre-perinatal risk scores and allocated successively to intervention or non-intervention groups . Cognitive development was assessed with the Bayley Scales at age two and with the WPPSI at age four . Attachment to primary caregiver was assessed with the Preschool Assessment of Attachment ( PAA ) . Cognitive performance was within age norms in both groups at both ages . Intervention did not show any effect on cognitive performance at the age of two years . At the age of four years , cognitive level was overall , and most notably for verbal performance , higher in the intervention group than in the control group . There was an over-representation of the so-called atypical attachment patterns ( those not fitting the normative A , B , or C categories ) in the control group . The results are discussed in terms of finding more global ways to support the development of at risk pre-term children",
"A recent federal law has exp and ed the eligibility for multidisciplinary evaluation and assessment of infants suspected of developmental delay . At the same time , modern neonatal care has increased infant survival . These two developments have created a need for family education regarding the need for health and developmental intervention , as well as counseling to maintain family participation in these services . This study compares the education and counseling services of a hospital-based case management team with the traditional discharge and follow-up services of a neonatal intensive care unit ( NICU ) . Subjects were the 10 % most medically severe infants discharged from a neonatal intensive care unit over a 16-month period . Preliminary data suggests a significantly greater number of families accessed community-based , coordinated , comprehensive health and developmental services when they received case management services . The data suggest that hospital professionals generally refer the most medically severe 3 % of this group for services under a traditional model . However , the additional 7 % referred under the transition model showed greater developmental benefits from the services during the first 6 months of life . These data support current federal initiatives for early intervention services which are family-centered , community-based and coordinated",
"This prospect i ve longitudinal study was design ed to evaluate the effects of a multidisciplinary infant development program ( IDP ) on the mental and physical development of low birth weight infants ( less than 1,800 g ) . Infants in the neonatal intensive care were r and omly assigned to the IDP or to traditional care ( control group ) . IDP infants received developmental interventions in the hospital and at home through the first 2 years of life . Counseling and parenting education were provided to their parents during this same period . The control group received all the postnatal care and referrals customarily given in traditional care . Both IDP and control infants were enrolled in an independent follow-up program , which used the Bayley Scales of Infant Development in a blind evaluation design . The IDP group had a significantly lower incidence of developmental delay ( P less than .05 ) and scored significantly higher than the control group ( P less than .05 ) on mean mental and physical indices at 12 and 24 months of adjusted age",
"CONTEXT Most studies of the long-term effects of early childhood educational interventions are of demonstration programs rather than large-scale public programs . Previous studies of one of the oldest federally funded preschool programs have reported positive effects on school performance , but effects on educational attainment and crime are unknown . OBJECTIVE To determine the long-term effectiveness of a federal center-based preschool and school-based intervention program for urban low-income children . DESIGN , SETTING , AND PARTICIPANTS Fifteen-year follow-up of a nonr and omized , matched-group cohort of 1539 low-income , mostly black children born in 1980 and enrolled in alternative early childhood programs in 25 sites in Chicago , Ill. INTERVENTIONS The Chicago Child-Parent Center ( CPC ) Program ( n = 989 children ) provides comprehensive education , family , and health services and includes half-day preschool at ages 3 to 4 years , half- or full-day kindergarten , and school-age services in linked elementary schools at ages 6 to 9 years . The comparison group ( n = 550 ) consisted of children who participated in alternative early childhood programs ( full-day kindergarten ) : 374 in the preschool comparison group from 5 r and omly selected schools plus 2 others that provided full-day kindergarten and additional instructional re sources and 176 who attended full-day kindergartens in 6 CPCs without preschool participation . MAIN OUTCOME MEASURES Rates of high school completion and school dropout by age 20 years , juvenile arrests for violent and nonviolent offenses , and grade retention and special education placement by age 18 years . RESULTS Relative to the preschool comparison group and adjusted for several covariates , children who participated in the preschool intervention for 1 or 2 years had a higher rate of high school completion ( 49.7 % vs 38.5 % ; P = .01 ) ; more years of completed education ( 10.6 vs 10.2 ; P = .03 ) ; and lower rates of juvenile arrest ( 16.9 % vs 25.1 % ; P = .003 ) , violent arrests ( 9.0 % vs 15.3 % ; P = .002 ) , and school dropout ( 46.7 % vs 55.0 % ; P = .047 ) . Both preschool and school-age participation were significantly associated with lower rates of grade retention and special education services . The effects of preschool participation on educational attainment were greater for boys than girls , especially in reducing school dropout rates ( P = .03 ) . Relative to less extensive participation , children with extended program participation from preschool through second or third grade also experienced lower rates of grade retention ( 21.9 % vs 32.3 % ; P = .001 ) and special education ( 13.5 % vs 20.7 % ; P = .004 ) . CONCLUSIONS Participation in an established early childhood intervention for low-income children was associated with better educational and social outcomes up to age 20 years . These findings are among the strongest evidence that established programs administered through public schools can promote children 's long-term success",
"BACKGROUND AND OBJECTIVE Care based on the Newborn Individualized Developmental Care and Assessment Program ( NIDCAP ) has been reported to exert a positive impact on the development of prematurely born infants . The aim of the present investigation was to determine the effect of such care on the 1-year development of infants born with a gestational age of less than 32 weeks . METHODS All surviving infants ( 11 in the NIDCAP group and 9 in the control group ) were assessed employing the Bayley Scales of Infant Development at 1 year of corrected age . RESULTS The Mental Developmental Index ( MDI ) of children who had received care according to NIDCAP was higher [ 88 ( 72 - 114 ) ] [ median ( range ) ] than the corresponding value for the control children [ 78 ( 50 - 82 ) ] ( p=0.01 ) . The odds ratio for being alive with an MDI>80 was 14 ( 95 % CI ; 1.4 - 141.5 ) in favour of the intervention group . However , the Psychomotor Developmental Indices ( PDI ) were not significantly different [ 85 ( 61 - 108 ) and 69 ( 50 - 114 ) , respectively ] ( p=0.23 ) . CONCLUSION Our findings indicate that care based on the NIDCAP might have a positive impact on the cognitive development of infants born very prematurely",
"At a corrected age of 3 months , 80 low birth-weight infants were assigned to normal or at-risk groups on the basis of a neurodevelopmental assessment scale . Both groups were further divided into intervention and non-intervention sub-groups ( 20 infants in each ) . Intervention consisted of monthly hospital-based neurodevelopmental therapy in addition to a home exercise programme . Infants were re-assessed by a physiotherapist at 6 , 9 , and 12 months , and were tested at 12 months by an independent psychologist blinded for infant group . Mean birthweight and gestational age were similar for normal and at-risk groups . At-risk infants had higher mean neurodevelopmental scores throughout the study period and lower 1-year development quotients ( DQ ) than normals . In neither normal nor at-risk groups did neurodevelopmental therapy alter the pattern of development or the outcome",
"Effects of high participation in the Infant Health and Development Program ( IHDP ) , an 8-site r and omized trial that targeted low-birth-weight ( LBW ) premature infants ( N=1,082 ) , were estimated . Children in the treatment group were offered high- quality center-based care in their 2nd and 3rd years of life ( full-day care , 50 weeks per year ) . High-dosage effects were estimated with a new methodology that found a matched comparison group within the follow-up group for those with high participation rates ; these estimates were compared with traditional intention-to-treat ( ITT ) estimates . At age 8 , effects on the Wechsler Intelligence Scale for Children Full and Verbal scales for children who attended > 400 days ranged from 7 to 10 points . For the heavier LBW infants ( 2,001 - 2,500 g ) , the effects were about 14 points for > 400 days ; for the lighter LBW infants ( substantially higher than corresponding ITT effects . Similar but smaller effects were found for children who attended > 350 days",
"Aims : To test the effectiveness of a home based developmental education intervention in improving outcome at 5 years for very preterm infants . Methods : The Avon Premature Infant Project ( APIP ) is a r and omised controlled trial in which the parents of 284 babies born developmental education programme , a social support intervention , or st and ard care . A term reference population was also recruited . This study reports outcomes at 5 years ( mean age 58 months 15 days ) for 187 ( 66 % ) of these children without disability . Outcomes were assessed using the British Ability Scales II for cognitive development , the Movement ABC for motor impairment , and the Child Behavior Checklist for behavioural problems . Results : Preterm infants showed poorer cognitive performance than their term peers . Mean ( SD ) general conceptual ability ( GCA ) scores were : Portage 99.2 ( 15.7 ) ; parent adviser 100.3 ( 14.8 ) ; preterm control 101.1 ( 15.0 ) ; term reference 107.2 ( 13.4 ) . There were no significant differences between preterm groups in GCA scores indicating no effect of either intervention . Similarly , there was no significant effect of intervention on behavioural or motor outcomes . Further analyses , in which outcome data were adjusted for social factors , did not reveal any differences between the three preterm groups or by subgroups classified by a range of perinatal variables . Conclusion : The small advantage shown at 2 years of age is no longer detectable at 5 years . These results question the effectiveness of early intervention in enhancing cognitive , behavioural , and motor function at 5 years",
"OBJECTIVE . To assess whether improvements in cognitive and behavioral development seen in preschool educational programs persist , we compared those in a multisite r and omized trial of such a program over the first 3 years of life ( INT ) to those with follow-up only ( FUO ) at 18 months of age . METHODS . This was a prospect i ve follow-up of the Infant Health and Development Program at 8 sites heterogeneous for sociodemographic characteristics . Originally 985 children were r and omized to the INT ( n = 377 ) or FUO ( n = 608 ) groups within 2 birth weight strata : heavier low birth weight ( HLBW ; 2001–2499 g ) and lighter low birth weight ( LLBW ; ≤2000 g ) . Primary outcome measures were the Peabody Picture Vocabulary Test ( PPVT-III ) , reading and mathematics subscales of the Woodcock-Johnson Tests of Achievement , youth self-report on the Total Behavior Problem Index , and high-risk behaviors on the Youth Risk Behavior Surveillance System ( YRBSS ) . Secondary outcomes included Weschler full-scale IQ , caregiver report on the Total Behavior Problem Index , and caregiver and youth self-reported physical health using the Medical Outcome Study measure . Assessors were masked as to study status . RESULTS . We assessed 636 youths at 18 years ( 64.6 % of the 985 , 72 % of whom had not died or refused at prior assessment s ) . After adjusting for cohort attrition , differences favoring the INT group were seen on the Woodcock-Johnson Tests of Achievement in math ( 5.1 points ) , YRBSS ( −0.7 points ) , and the PPVT-III ( 3.8 points ) in the HLBW youth . In the LLBW youth , the Woodcock-Johnson Tests of Achievement in reading was higher in the FUO than INT group ( 4.2 ) . CONCLUSIONS . The findings in the HLBW INT group provide support for preschool education to make long-term changes in a diverse group of children who are at developmental risk . The lack of observable benefit in the LLBW group raises questions about the biological and educational factors that foster or inhibit sustained effects of early educational intervention",
"To determine the safety , efficacy , and cost savings of early hospital discharge of very-low-birth-weight infants ( less than or equal to 1500 g ) , we r and omly assigned infants to one of two groups . Infants in the control group ( n = 40 ) were discharged according to routine nursery criteria , which included a weight of about 2200 g. Those in the early-discharge group ( n = 39 ) were discharged before they reached this weight if they met a st and ard set of conditions . For families of infants in the early-discharge group , instruction , counseling , home visits , and daily on-call availability of a hospital-based nurse specialist for 18 months were provided . Infants in the early-discharge group were discharged a mean of 11 days earlier , weighed 200 g less , and were two weeks younger at discharge than control infants . The mean hospital charge for the early-discharge group was 27 percent less than that for the control group ( $ 47,520 vs. $ 64,940 ; P less than 0.01 ) , and the mean physician 's charge was 22 percent less ( $ 5,933 vs. $ 7,649 ; P less than 0.01 ) . The mean cost of the home follow-up care in the early-discharge group was $ 576 , yielding a net saving of $ 18,560 for each infant . The two groups did not differ in the numbers of rehospitalizations and acute care visits , or in measures of physical and mental growth . We conclude that early discharge of very-low-birth-weight infants , with follow-up care in the home by a nurse specialist , is safe and cost effective",
"OBJECTIVE The Neonatal Individualized Developmental Care Program ( NIDCAP ) for very low birth weight ( VLBW ) preterm infants has been suggested by Als et al to improve several medical outcome variables such as time on ventilator , time to nipple feed , the duration of hospital stay , better behavioral performance on Assessment of Preterm Infants ' Behavior ( APIB ) , and improved neurodevelopmental outcomes . We have tested the hypothesis of whether the infants who had received NIDCAP would show advanced sleep-wake pattern , behavioral , and neurodevelopmental outcome . METHODS Thirty-five VLBW infants were r and omly assigned to receive NIDCAP or routine infant care . The goals for NIDCAP intervention were to enhance comfort and stability and to reduce stress and agitation for the preterm infants by : a ) altering the environment by decreasing excess light and noise in the neonatal intensive care unit ( NICU ) and by using covers over the incubators and cribs ; b ) use of positioning aids such as boundary supports , nests , and buntings to promote a balance of flexion and extension postures ; c ) modification of direct h and s-on caregiving to maximize preparation of infants for , tolerance of , and facilitation of recovery from interventions ; d ) promotion of self-regulatory behaviors such as holding on , grasping , and sucking ; e ) attention to the readiness for and the ability to take oral feedings ; and f ) involving parents in the care of their infants as much as possible . The infants ' sleep was recorded at 36 weeks postconceptional age ( PCA ) and at 3 months corrected age ( CA ) using the Motility Monitoring System ( MMS ) , an automated , nonintrusive procedure for determining sleep state from movement and respiration patterns . Behavioral and developmental outcome was assessed by the Neurobehavioral Assessment of the Preterm Infant ( NAPI ) at 36 weeks PCA , the APIB at 42 weeks PCA , and by the Bayley Scales of Infant Development ( BSID ) at 4 , 12 , and 24 months CA . RESULTS Sleep developmental measures at 3 months CA showed a clear developmental change compared with 36 weeks PCA . These include : increased amount of quiet sleep , reduced active sleep and indeterminate sleep , decreased arousal , and transitions during sleep . Longest sleep period at night showed a clear developmental effect ( increased ) when comparing nighttime sleep pattern of infants at 3 months with those at 36 weeks of age . Day-night rhythm of sleep-wake increased significantly from 36 weeks PCA to 3 months CA . However , neither of these sleep developmental changes showed any significant effects of NIDCAP intervention . Although all APIB measures showed better organized behavior in NIDCAP patients , neither NAPI nor Bayley showed any developmental advantages for the intervention group . The neurodevelopmental outcome measured by the Bayley at 4 , 12 , and 24 months CA showed 64 % of the NIDCAP intervention group at the lowest possible score compared with 33 % of the control group . These findings could not be explained by the occurrence of intraventricular hemorrhage or the socioeconomic status of the parents , which showed no significant group effect . CONCLUSION The results of this study , including measures of sleep maturation and neurodevelopmental outcome up to 2 years of age did not demonstrate that the NIDCAP intervention results in increased maturity or development . Buehler et al ( Pediatrics . 1995;96:923 - 932 ) have reported that premature infants ( N = 12 ; mean gestational age 32 weeks , mean birth weight 1700 g ) who received developmental care compared with a similar group of infants who received routine care showed better organized behavioral performance on an APIB assessment at 42 weeks PCA . None of the medical outcome measures were significantly different in this study . Although our APIB results are in agreement , the results of the NAPI , the Bayley and sleep measures do not show an increase in neurodevelopmental maturation . In the earlier report by Als et al ( Journal of the American Medical",
"A r and omized controlled trial was carried out for 1 y in three tertiary and teaching hospitals , in Addis Ababa ( Ethiopia ) , Yogyakarta ( Indonesia ) and Merida ( Mexico ) , to study the effectiveness , feasibility , acceptability and cost of kangaroo mother care ( KMC ) when compared to conventional methods of care ( CMC ) . About 29 % of 649 low birthweight infants ( LBWI ; 1000‐1999 g ) died before eligibility . Of the survivors , 38 % were excluded for various reasons , 149 were r and omly assigned to KMC ( almost exclusive skin‐to‐skin care after stabilization ) , and 136 to CMC ( warm room or incubator care ) . There were three deaths in each group and no difference in the incidence of severe disease . Hypothermia was significantly less common in KMC infants in Merida ( 13.5 vs 31.5 episodes/100 infants/d ) and overall ( 10.8 vs 14.6 ) . Exclusive breastfeeding at discharge was more common in KMC infants in Merida ( 80 % vs 16 % ) and overall ( 88 % vs 70 % ) . KMC infants had a higher mean daily weight gain ( 21.3 g vs 17.7 g ) and were discharged earlier ( 13.4 vs 16.3 d after enrolment ) . KMC was considered feasible and presented advantages over CMC in terms of maintenance of equipment . Mothers expressed a clear preference for KMC and health workers found it safe and convenient . KMC was cheaper than CMC in terms of salaries ( US$ 11 788 vs US$ 29 888 ) and other running costs ( US$ 7501 vs US$ 9876 ) . This study confirms that hospital KMC for stabilized LBWI 1000‐1999 g is at least as effective and safe as CMC , and shows that it is feasible in different setting s , acceptable to mothers of different cultures , and less expensive . Where exclusive breastfeeding is uncommon among LBWI , KMC may bring about an increase in its prevalence and duration , with consequent benefits for health and growth . For hospitals in low‐income countries KMC may represent an appropriate use of scarce re sources",
"OBJECTIVE To investigate the effects of early experience on brain function and structure . METHODS A r and omized clinical trial tested the neurodevelopmental effectiveness of the Newborn Individualized Developmental Care and Assessment Program ( NIDCAP ) . Thirty preterm infants , 28 to 33 weeks ' gestational age ( GA ) at birth and free of known developmental risk factors , participated in the trial . NIDCAP was initiated within 72 hours of intensive care unit admission and continued to the age of 2 weeks , corrected for prematurity . Control ( 14 ) and experimental ( 16 ) infants were assessed at 2 weeks ' and 9 months ' corrected age on health status , growth , and neurobehavior , and at 2 weeks ' corrected age additionally on electroencephalogram spectral coherence , magnetic resonance diffusion tensor imaging , and measurements of transverse relaxation time . RESULTS The groups were medically and demographically comparable before as well as after the treatment . However , the experimental group showed significantly better neurobehavioral functioning , increased coherence between frontal and a broad spectrum of mainly occipital brain regions , and higher relative anisotropy in left internal capsule , with a trend for right internal capsule and frontal white matter . Transverse relaxation time showed no difference . Behavioral function was improved also at 9 months ' corrected age . The relationship among the 3 neurodevelopmental domains was significant . The results indicated consistently better function and more mature fiber structure for experimental infants compared with their controls . CONCLUSIONS This is the first in vivo evidence of enhanced brain function and structure due to the NIDCAP . The study demonstrates that quality of experience before term may influence brain development significantly",
"CONTEXT Few studies document how parents adapt to the experience of a very low-birth-weight ( VLBW ; despite societal concerns about the ethics and justification of intensive care for these infants . OBJECTIVE To determine the degree and type of stress experienced over time by mothers whose infants vary in degree of prematurity and medical and developmental risk . DESIGN Longitudinal prospect i ve follow-up study of a cohort of mothers of high- and low-risk VLBW and term infants from birth to 3 years . SETTING All level III neonatal intensive care units from a large midwestern metropolitan region . PARTICIPANTS Mothers and infants prospect ively and consecutively enrolled in a longitudinal study between 1989 and 1991 . High-risk VLBW infants were diagnosed as having bronchopulmonary dysplasia , and comparison groups were low-risk VLBW infants without bronchopulmonary dysplasia and term infants ( > 36 weeks , > 2500 g ) . MAIN OUTCOME MEASURES St and ardized , normative self-report measures of maternal psychological distress , parenting stress , family impact , and life stressors . RESULTS Mothers of VLBW infants ( high risk , n = 122 ; low risk , n = 84 ) had more psychological distress than mothers of term infants ( n=123 ) at 1 month ( 13 % vs 1 % ; P = .003 ) . At 2 years , mothers of low-risk VLBW infants did not differ from term mothers , while mothers of high-risk infants continued to report psychological distress . By 3 years , mothers of high-risk VLBW children did not differ from mothers of term children in distress symptoms , while parenting stress remained greater . Severity of maternal depression was related to lower child developmental outcomes in both VLBW groups . CONCLUSIONS The impact of VLBW birth varies with child medical risk status , age , and developmental outcome . Follow-up programs should incorporate psychological screening and support services for mothers of VLBW infants in the immediate postnatal period , with monitoring of mothers of high-risk VLBW infants",
"Mothers of low-birthweight babies born at the Medical Center Hospital of Vermont during a 21-month period were r and omly assigned to experimental ( N = 34 ) and control ( N = 40 ) groups . Forty-one normal-birthweight controls were also recruited . Experimental mothers received an 11-session intervention program which emphasized maternal sensitivity and responsiveness to infant social signals . This paper analyzes the impact of the program , by 6 months , on maternal adaptation and psychopathology , and on infant cognitive development and temperament",
"CONTEXT Despite more than 2 decades of outcomes research after very preterm birth , clinicians remain uncertain about the extent to which neonatal morbidities predict poor long-term outcomes of extremely low-birth-weight ( ELBW ) infants . OBJECTIVE To determine the individual and combined prognostic effects of bronchopulmonary dysplasia ( BPD ) , ultrasonographic signs of brain injury , and severe retinopathy of prematurity ( ROP ) on 18-month outcomes of ELBW infants . DESIGN Inception cohort assembled for the Trial of Indomethacin Prophylaxis in Preterms ( TIPP ) . SETTING AND PARTICIPANTS A total of 910 infants with birth weights of 500 to 999 g who were admitted to 1 of 32 neonatal intensive care units in Canada , the United States , Australia , New Zeal and , and Hong Kong between 1996 and 1998 and who survived to a postmenstrual age of 36 weeks . MAIN OUTCOME MEASURES Combined end point of death or survival to 18 months with 1 or more of cerebral palsy , cognitive delay , severe hearing loss , and bilateral blindness . RESULTS Each of the neonatal morbidities was similarly and independently correlated with a poor 18-month outcome . Odds ratios were 2.4 ( 95 % confidence interval [ CI ] , 1.8 - 3.2 ) for BPD , 3.7 ( 95 % CI , 2.6 - 5.3 ) for brain injury , and 3.1 ( 95 % CI , 1.9 - 5.0 ) for severe ROP . In children who were free of BPD , brain injury , and severe ROP the rate of poor long-term outcomes was 18 % ( 95 % CI , 14%-22 % ) . Corresponding rates with any 1 , any 2 , and all 3 neonatal morbidities were 42 % ( 95 % CI , 37%-47 % ) , 62 % ( 95 % CI , 53%-70 % ) , and 88 % ( 64%-99 % ) , respectively . CONCLUSION In ELBW infants who survive to a postmenstrual age of 36 weeks , a simple count of 3 common neonatal morbidities strongly predicts the risk of later death or neurosensory impairment",
"OBJECTIVE To examine long-term outcomes in families of children with very low birth weights ( in relation to the extent of low birth weight and neonatal medical risk . DESIGN Concurrent/cohort prospect i ve study . SETTING Regional follow-up program . PARTICIPANTS Families of 60 children of school age with birth weights less than 750 g , 55 with birth weights between 750 and 1499 g , and 49 normal birth weight full-term controls . MAIN OUTCOME MEASURES Parent ratings of psychological distress , family function , and child-related stress . RESULTS Families with children with birth weights less than 750 g experienced greater stress than did families of controls ( born at full term ) , and families who were sociodemographically advantaged experienced greater stress than did those who were disadvantaged . Higher neonatal medical risk also predicted a more negative impact on the family , but only in advantaged families . Regression analyses suggested that adverse family outcomes were mediated by ongoing problems in child functioning . CONCLUSIONS Families of children with birth weights less than 750 g experience more long-term adversity than families of full-term children . Family sequelae are also present for children with very low birth weight at high neonatal medical risk . Ongoing child health and behavior problems may be the major source of these sequelae , and sociodemographic status is an important consideration in identifying family adversity . Although many families appear unaffected , results support the need to monitor family outcomes and develop interventions for both the child and family",
"The outcome of an early intervention program for low-birthweight ( LBW ) infants was examined in this study . The intervention consisted of 11 sessions , beginning during the final week of hospitalization and extending into the home over a 3-month period . The program aim ed to facilitate maternal adjustment to the care of a LBW infant , and , indirectly , to enhance the child 's development . Neonates weighing less than 2,200 grams and under 37 weeks gestational age were r and omly assigned to experimental or control conditions . A full-term , normal birthweight ( NBW ) group served as a second control . 6-month analyses of dyads who completed all assessment s over a 4-year period ( N 's = 25 LBW experimental , 29 LBW control , and 28 NBW infant-mother dyads ) showed that the experimental group mothers reported significantly greater self-confidence and satisfaction with mothering , as well as more favorable perception of infant temperament than LBW control group mothers . A progressive divergence between the LBW experimental and LBW control children on cognitive scores culminated in significant group differences on the McCarthy GCI at ages 36 and 48 months , when the LBW experimental group caught up to the NBW group . Possible explanations for the observed delay in the emergence of intervention effects on cognitive development and the mediating role of favorable mother-infant transactional patterns are discussed in light of recent evidence from the literature",
"OBJECTIVE To investigate the effectiveness of individualized developmental care in reducing medical and neurodevelopmental sequelae for very low-birth-weight infants . DESIGN R and omized controlled trial . SETTING Newborn intensive care unit . PATIENTS Thirty-eight singleton preterm infants , free of known congenital abnormalities , weighing less than 1250 g , born before 30 weeks ' gestation , mechanically ventilated within 3 hours of delivery and for more than 24 hours in the first 48 hours , r and omly assigned to a control or an experimental group . INTERVENTION Caregiving by nurses specifically trained in individualized developmental care ; observation and documentation of the infants ' behavior within 12 hours of admission , and subsequently every 10th day ; developmental care recommendations and ongoing clinical support for the nurses and parents based on regular observation of the infant by developmental specialists ; and the availability of special caregiving accessories . MAIN OUTCOME MEASURES Medical outcome , including average daily weight gain ; number of days the infant required mechanical ventilation , oxygen , gavage tube feeding , and hospitalization ; severity of retinopathy of prematurity , bronchopulmonary dysplasia , pneumothorax , and intraventricular hemorrhage ; pediatric complications ; age at discharge ; and hospital charges . Neurodevelopmental outcome , including Assessment of Preterm Infants ' Behavior scale and quantified electroencephalography ( 2 weeks after due date ) ; and Bayley Scales of Infant Development and Kangaroo Box Paradigm ( 9 months after due date ) . RESULTS The infants in the experimental group had a significantly shorter duration of mechanical ventilation and supplemental oxygen support ; earlier oral feeding ; reduced incidence of intraventricular hemorrhage , pneumothorax , and severe bronchopulmonary dysplasia ; improved daily weight gain ; shorter hospital stays ; younger ages at hospital discharge ; and reduced hospital charges compared with the infants in the control group . At 2 weeks after their due date s , these infants also showed improved autonomic regulation , motor system functioning , self-regulatory abilities , and visual evoked potential measures ; and at 9 months , they had improved Bayley Mental and Psychomotor Developmental Index scores , as well as Kangaroo Box Paradigm scores . CONCLUSION Very low-birth-weight preterm infants may benefit from individualized developmental care in the neonatal intensive care unit in terms of medical and neurodevelopmental outcome",
"AIM To test the effectiveness of a home based developmental education programme in very preterm children . METHODS A r and omised controlled trial was conducted of developmental or social support intervention , started at discharge for up to 2 years , in 309 consecutive survivors of 32 weeks gestation or less , born to mothers resident in greater Bristol between December 1990 and July 1993 . Home visits were made by research nurses trained in either Portage ( a developmental education programme ) or in nondirectional counselling ( parent adviser scheme ) . Interventions were also provided to appropriate primary care and community support for disability . Griffiths Mental Development Scales were used to assess outcome at 2 years . RESULTS Mean ( SEM ) Griffiths quotients ( GQ ) were : Portage 96.8 ( 1.6 ) ; parent adviser 95.9 ( 1.6 ) ; preterm control 92.9 ( 2.0 ) . Despite r and omisation , social variables significantly confounded these results . Using linear regression analysis , intervention was associated with improved scores : Portage : + 4.3 GQ points ( 95 % CI 1.6 to 7.0 ) ; parent adviser : + 3.4 GQ points ( 1.4 to 6.1 ) . The effect of Portage was greatest in those children with birthweights developmental benefit from long term family support after preterm birth . Secondary analysis controlling for the presence of adverse social markers showed similar small advantage for both intervention groups . In the smallest infants and those with brain injuries , a structured developmental programme may offer advantage over social support intervention",
"The Infant Health and Development Program is an eight-site clinical trial design ed to evaluate the efficacy of a comprehensive early intervention in reducing the developmental and health problems of low-birth-weight ( less than or equal to 2500 g ) premature ( less than or equal to 37 weeks ) infants . Nine hundred eighty-five infants , stratified by site and weight ( less than or equal to 2000 g or 2001 to 2500 g ) , were r and omly assigned to receive an educational curriculum focused on child development , as well as family support and pediatric follow-up , or only pediatric follow-up . At corrected age 36 months , the intervention group had significantly higher mean IQ scores than the follow-up group ( mean difference in the heavier group was 13.2 and in the lighter group 6.6 ) , significantly fewer maternally reported behavior problems , and a small , but statistically significant , increase in maternally reported minor illnesses for the lighter-birth-weight group only , with no difference in serious health conditions",
"Background and Objective . Family-centered developmentally supportive care of very low birth weight infants , provided by the Newborn Individualized Developmental Care and Assessment Program ( NIDCAP ) has been reported to have positive medical and economic impacts . Our aim was to investigate its effect on need of ventilatory assistance , growth , and hospitalization in a Swedish setting . Methods . Preterm infants born between September 1994 and April 1997 with a gestational age NIDCAP ( n = 12 ) or conventional care ( n = 13 ) . The 2 groups were comparable ( median [ range ] ) with respect to birth weight ( 1083 [ 630–1411 ] vs 840[636–1939 g ] ) , head circumference ( 24.0 [ 22.3–26.5 ] vs 24.0 [ 21.1–30.0 cm ] ) , gestational age ( 27.6 [ 24.0–28.7 ] vs 26.1 [ 23.9–30.3 ] weeks ) , female/male ratio ( 3/9 vs 9/8 ) and Clinical Risk Index for Babies ( 4.0 [ 0–11 ] vs 6.0 [ 2–15 ] ) . The infants in the intervention group were cared for in a separate room by a group of specially trained nurses . Formal weekly observations of these infants starting within 3 days after birth and continuing until 36 weeks postconception were used to develop individualized care plans . These plans provided recommendations as to how care might be attuned to the current developmental stage of the infant and how the family might be supported and stimulated to participate in this care . The treatment of the 2 groups was in all other respects identical . Results . The duration of mechanical ventilation ( median [ range ] was 2.8 [ 0–36.7 ] days in the intervention group vs 4.8 [ .1–29.8 ] days ; not significant [ NS ] ) among the controls and continuous positive airway pressure was applied for 26.1 ( 6.9–52.0 ) vs 43.9 ( 5.0–65.1 ) days . Supplementary oxygen was withdrawn at 33.0 ( 29.3–35.7 ) vs 38.1 ( 33.1–44.9 ) weeks of postconceptional age ( PCA ) . The weight gain up to 35 weeks of PCA was 13.0 ( 6.7–21.0 ) vs 9.8 ( 6.8–16.6 ) g/day ( NS ) . The head growth up to 35 weeks of PCA was .73 ( .56–1.3 ) vs .63 ( .56-.77 ) cm/week ( NS ) . The age of the infant at discharge was 38.3 ( 36.1–57.7 ) vs 41.0 ( 36.9–48.4 ) weeks of PCA ( NS ) . Conclusions . NIDCAP does not seem to have detrimental effects on Swedish very low birth weight infants in comparison with conventional care . Indeed , NIDCAP might even be advantageous",
"OBJECTIVE To assess the effectiveness and safety of Kangaroo Mother Care ( KMC ) for infants of low birth weight . METHODS An open , r and omized , controlled trial of a Colombian social security referral hospital was conducted . A total of 1084 consecutive infants who were born at KMC and 364 to \" traditional \" care . Information on vital status was available for 693 infants ( 93 % ) at 12 months of corrected age . KMC consisted of skin-to-skin contact on the mother 's chest 24 hours/day , nearly exclusive breastfeeding , and early discharge , with close ambulatory monitoring . Control infants remained in incubators until the usual discharge criteria were met . Both groups were followed at term and at 3 , 6 , 9 , and 12 months of corrected age . The main outcomes measured were morbidity , mortality , growth , development , breastfeeding , hospital stay , and sequelae . RESULTS Baseline variables were evenly distributed , except for weight at recruitment ( KMC : 1678 g ; control participants : 1713 g ) . The risk for death was lower among infants who were given KMC , although the difference was not significant ( KMC : 11 [ 3.1 % ] of 339 ; control participants : 19 [ 5.5 % ] of 324 ; relative risk : 0.57 ; 95 % confidence interval : 0.17 - 1.18 ) . The growth index of head circumference was statistically significantly greater in the group given KMC , but the developmental indices of the 2 groups were similar . Infants who weighed KMC spent less time in the hospital than those who were given st and ard care . The number of infections was similar in the 2 groups , but the severity was less among infants who received KMC . More of these infants were breastfed until 3 months of corrected age . CONCLUSION These results support earlier findings of the beneficial effects of KMC on mortality and growth . Use of this technique would humanize the practice of neonatology , promote breastfeeding , and shorten the neonatal hospital stay without compromising survival , growth , or development",
"It has been proposed that the developmentally supportive care of very‐low‐birthweight ( VLBW ) infants provided by the Newborn Individualized Developmental Care and Assessment Program ( NIDCAP ) can improve the infants ' opportunities for rest and sleep . The aim of the present study was to determine whether quiet sleep ( QS ) in VLBW infants is affected by NIDCAP care . Twentytwo infants with a gestational age of NIDCAP ( n= 11 ) or conventional care ( n= 11 ) . These two groups were comparable ( mean ( SD ) ) with respect to birthweight ( 1021 ( 240 ) vs 913 ( 362 ) g , respectively ) and gestational age ( 27.1 ( 1.7 ) vs 26.4 ( 1.8 ) wk ) . The infants in the NIDCAP group were cared for in a separate room by a group of specially trained nurses and subjected to weekly NIDCAP observations until they reached a postconceptional age ( PCA ) of 36 wk . Quiet sleep ( QS ) was assessed from 24‐h amplitude‐integrated EEGs recorded at 32 and 36 wk of PCA . The percentage of time [ mean ( SD ) ] spent in QS at 32 wk of PCA was 33.5 ( 2.6 ) % for the NIDCAP group and 33.3 (6.9)% for the control infants ( ns ) . At 36 wk , the corresponding values were 24.5 (3.2)% and 25.7 (4.7)% , respectively ( ns ) . The number of QS periods/24 h decreased equally in both groups in association with maturation : from 24.6 ( 3.3 ) to 16.8 ( 1.8 ) and from 25.0 ( 5.8 ) to 17.5 ( 3.3 ) , at 32 wk , and 36 wk of PCA , respectively ( NS )",
"ABSTRACT . We investigated the effects of a 1 -year home intervention on premature infants with low ( were block r and omly assigned to a control or to one of two treatment groups . One treatment group focused on the development of the infant ; the other treatment group focused on the parent-infant interaction . The low birth weight infants obtained significantly lower Bayley mental and motor scores , and were more passive and less intense than the higher birth weight infants . However , the low birth weight infants and their parents were more responsive to the home intervention than were the higher birth weight infants , as demonstrated by changes in the Bayley mental scores and the Home Observation for Measurement of the Environment ( HOME ) inventory . These findings exemplify the reciprocal relationship between the child 's characteristics and parental responding . The importance of selecting the most high-risk premature infants for early home intervention is outlined",
"The effects of nursery-based intervention with healthy , prematurely born babies and their socially disadvantaged mothers were evaluated . Mother-infant dyads were r and omly assigned to one of three intervention groups : In group one , the babies received special stimulation design ed to make them more active contributors to the interactions with their mothers ; in group two , mothers received special training to help them become more responsive to cues from their babies ; in group three , infants received stimulation and mothers received training . In addition , a fourth group of preterm babies who received regular hospital care served as a comparison group to assess the short-term effects of the stimulation program . Outcome measures design ed to evaluate various aspects of mother-infant interaction and infant development failed to reflect any effects of the interventions , either at the time the babies were discharged from the hospital or one year later . We attribute the lack of positive findings to the fact that the mothers faced numerous crises in their social environments . We conclude , therefore , that nothing short of massive social change is likely to result in measurable effects",
"OBJECTIVE To evaluate the persistence of effects on health and development at age 5 years of the Infant Health and Development Program , an early childhood intervention that was provided to low-birth-weight ( LBW ) premature infants from neonatal discharge through age 3 years . DESIGN R and omized , controlled , multicenter trial , stratified by two LBW groups : lighter ( Eight socioeconomically heterogeneous clinical sites . PARTICIPANTS Of 985 eligible infants weighing 2500 g or less and at 37 weeks ' or less gestational age , 377 infants were r and omly assigned to the intervention group and 608 to the follow-up only group . About two thirds of the infants in each group were in the lighter LBW stratum , and one third were in the heavier LBW stratum . INTERVENTION The intervention group received home visits ( from neonatal discharge through age 3 years ) as well as center-based schooling ( from 1 to 3 years of age ) . Children in both groups received pediatric surveillance . MAIN OUTCOME MEASURES Cognitive development , behavioral competence , and health status . RESULTS At age 5 years , the intervention group had full-scale IQ scores similar to children in the follow-up only group . However , in the heavier LBW stratum , children in the intervention group had higher full-scale IQ scores ( 3.7 points higher ; P = .03 ) and higher verbal IQ scores ( 4.2 points higher ; P = .02 ) . No significant differences between intervention and follow-up only groups in cognitive measures at age 5 years were noted in the lighter LBW infants . The intervention and follow-up groups were similar in behavior and health measures regardless of LBW stratum . CONCLUSION The early childhood intervention provided in the first 3 years of life had effects on heavier LBW premature infants ' IQ and verbal performance at age 5 years that were not observed for lighter LBW premature infants . The intervention did not affect health or behavior at age 5 years in either LBW stratum",
"The purpose of this pilot study was to evaluate the effectiveness of a parent-focused intervention program ( COPE ) on infant cognitive development and maternal coping . A r and omized clinical trial was conducted with 42 mothers of low-birth-weight ( LBW ) premature infants hospitalized in a neonatal intensive care unit ( NICU ) , with follow-up at 3 months ' and 6 months ' corrected ages . COPE mothers received the four-phase educational-behavioral program that began 2 - 4 days postbirth and continued through 1 week following discharge from the NICU . Comparison mothers received audiotaped information during the same four time frames . Results indicated that COPE infants had significantly higher mental development scores at a 3 months ' corrected age ( M = 100.3 ) than did the comparison infants ( M = 93.9 ) , and this difference widened at 6 months ' corrected age , with COPE infants scoring 14 points higher . COPE mothers were significantly less stressed by the NICU sights and sounds and had significantly stronger beliefs about what behaviors and characteristics to expect from their premature infants . Findings from this study support the need for further testing of early NICU interventions with parents to determine their effectiveness on parental coping and infant developmental outcomes",
"Many preterm infants cared for in incubators do not experience Kangaroo Care ( KC ) , skin-to-skin contact with their mothers , due to fear of body heat loss when being held outside the incubator . A r and omized clinical trial of 16 KC and 13 control infants using a pretest-test-posttest design of three consecutive interfeeding intervals of 2.5 to 3.0 h duration each was conducted over 1 day . Infant abdominal and toe temperatures were measured in and out of the incubator ; maternal breast temperature was measured during KC . Repeated measures ANOVA showed no change in abdominal temperature across all periods and between groups . Toe temperatures were significantly higher during KC than incubator periods , and maternal breast temperature met each infant ’s neutral thermal zone requirements within 5 min of onset of KC . Preterm infants similar to those studied here will maintain body warmth with up to 3 h of KC",
"Thirty healthy preterm infants were r and omly assigned either to a control group or to one of two experimental groups . The mothers of the first experimental group were present during an administration of the Brazelton Neonatal Behavioral Assessment Scale and were asked to complete the Mother 's Assessment of the Behavior of Her Infant Scale ( MABI ) at birth and weekly for four weeks after the discharge of their infants . The mothers of the second experimental group were not present during the administration of the Brazelton scale , but were asked to complete the MABI scale at birth and weekly for the first month after discharge . The mothers of the control infants did not observe administration of the Brazelton scale or complete the MABI scale , but were asked to complete a question naire on the developmental milestones of their infants . At 1 , 4 , and 12 months of age these infants were visited in their homes by teams of research ers blind to the hypothesis of the study and to the group assignment of the infants . The results at 1 month demonstrated that the experimental groups performed more optimally on the Brazelton scale interactive process items . These infants also received superior ratings on the video-taped feeding and face-to-face play sequences . At 4 months the experimental group infants showed better fine motor-adaptive abilities on the Denver Developmental Screening Test than did the control group . In addition , the face-to-face interaction ratings of the two experimental groups were significantly better that were those of the control group . The Bayley Scales of Infant Development were administered when the infants were 12 months corrected age . The infants of the experimental groups received significantly higher scores on the Mental Development Scale . This study suggests that teaching mothers the amazing skills of their newborns on the Brazelton and MABI scales may facilitate early interactions which , in turn , may contribute to early cognitive development",
"AIM Care based on the Newborn Individualized Developmental Care and Assessment Program ( NIDCAP ) has been reported to exert a positive impact on the development of prematurely born infants . The aim of the present investigation was to determine the effect of such care on the development at preschool age of children born with a gestational age of less than 32 wk . METHODS All surviving infants in a r and omised controlled trial with infants born at a postmenstrual age less than 32 wk ( 11 in the NIDCAP group and 15 in the control group ) were examined at 66.3 ( 6.0 ) mo corrected for prematurity [ mean ( SD ) ] . In the assessment we employed the Wechsler Preschool and Primary Scale of Intelligence-Revised ( WPPSI-R ) for cognition , Movement Assessment Battery for Children ( Movement ABC ) for motor function , subtests of the NEPSY test battery for attention and distractibility , and the WHO definitions of impairment , disability and h and icap . Exact binary logistic regression was employed . RESULTS There were no significant differences between the intervention group in Full-Scale IQ 93.4 ( 14.2 ) [ mean ( SD ) ] versus the control group 89.6 ( 27.2 ) , Verbal IQ 93.6 ( 16.4 ) versus 93.7 ( 26.8 ) or Performance IQ 94.3 ( 14.7 ) versus 86.3 ( 24.8 ) . In the NIDCAP group 8/13 ( 62 % ) survived without disability and for the children with conventional care this ratio was 7/19 ( 37 % ) . The corresponding ratios for surviving without mental retardation were 10/13 ( 77 % ) and 11/19 ( 58 % ) , and for surviving without attention deficits 10/13 ( 77 % ) and 10/19 ( 53 % ) . Overall , the differences were not statistically significant , although the odds ratio for surviving with normal behaviour was statistical significant after correcting for group imbalances in gestational age , gender , growth retardation and educational level of the parents . CONCLUSION Our trial suggests a positive impact by NIDCAP on behaviour at preschool age in a sample of infants born very prematurely . However , due to problems of recruitment less than half of the anticipated subjects were included in the study , which implies a low power and calls for caution in interpreting our findings . Larger trials in different cultural context s are warranted",
"OBJECTIVE To determine the effect of an early intervention programme ( EIP ) on low birthweight infants with cerebral injuries . METHODS Subjects were 23 high-risk low birthweight infants ( periventricular leukomalacia 15 , intraventricular haemorrhage 5 , both 3 ) receiving care in the neonatal intensive care unit ( NICU ) at Nagasaki University Hospital . Subjects were r and omly assigned to the EIP group ( n = 12 ) or the control group ( n = 11 ) . Participants in the EIP group received a Neonatal Behavioral Assessment scale (NBAS)-based intervention combined with developmental support design ed to enhance the infants ' development and the quality of the parent-infant relationship . The control group received routine medical nursing care without the EIP . The EIP began prior to discharge from the NICU and lasted until 6 months of corrected age . All children were examined on the NBAS preintervention and again at 44 weeks postconceptional age . Maternal anxiety status ( STAI ) and maternal feelings of confidence in dealing with her baby ( LCC ) were measured pre and postintervention . Mental and motor development was assessed postintervention using the Bayley Scale of Infant Development . RESULTS Orientation and State Regulation of infant behavioural profiles , the STAI and LCC scores significantly improved in the EIP group ( mean difference ( 95 % CI ) : Orientation 0.7 ( 0.4 , 1.1 ) , State Regulation 0.9 ( 0.3 , 1.5 ) , STAI -5.5 ( - 9.1 , -1.9 , LCC 5.3 ( 4.2 , 6.5 ) ) , but not in the control group . Bayley mental developmental index ( MDI ) score in the EIP group was higher than in the control group , but there was no significant difference between the two groups ( mean difference ( 95 % CI ) : MDI 8.5 ( - 0.8 , 17.8 ) , PDI 6.7 ( - 1.9 , 15.4 ) ) . CONCLUSION The EIP has beneficial effects on neonatal neurobehavioural development and maternal mental health of low birthweight infants with cerebral injuries . This evidence suggests that short-term changes in maternal mental health and infant neurobehaviour promoted by an EIP may serve to initiate a positive interaction between parents and infants",
"BACKGROUND Several studies report increased minor neurodevelopment dysfunctions in children born very low birth weight ( VLBW ) . Usefulness of preventive early intervention programs to improve neurodevelopment outcome of VLBW infants is still under investigation . AIMS To evaluate the effects of an early post-discharge developmental mother-child intervention program on neurodevelopment outcome at 36 months in VLBW infants . STUDY DESIGN Prospect i ve study . SUBJECTS 36 VLBW infants ( [ mean ( S.D. ) ] birthweight=864 g ( 204 g ) ; gestational age=27.9 weeks ( 2.4 weeks ) ) , consecutively born January-August 2001 , r and omized in intervention and control groups . OUTCOME MEASURES Neurodevelopment assessment at 36 months of chronological age with use of the Griffiths Mental Development Scale and related subscales . RESULTS At 36 months of chronological age , as compared to controls , children in intervention group exhibited higher scores in personal-social subscales ( [ mean (S.D.)]=101.4 ( 9.3 ) vs. 92.9 ( 12.1 ) , P=0.02 ) , eye-h and coordination ( 92.7 ( 4.5 ) vs. 87.1 ( 9.9 ) , P=0.041 ) , practical reasoning ( 98.6 ( 8.2 ) vs. 89.4 ( 10.1 ) , P=0.01 ) . Development Scale were 97.6 ( 5.5 ) and 92.4 ( 9.9 ) , respectively , in intervention and control groups ( P=0.074 ) . CONCLUSIONS Early post-discharge developmental mother-child intervention program may have a positive effect on later neurodevelopment outcome of VLBW children",
"BACKGROUND Prolonged hospitalization of low birth weight infants increases the risk of medical and psychosocial complications . The feasibility of earlier discharge with community-based follow-up of infants of , without the use of home apnea monitors , was investigated . METHODS One hundred infants of to either an intervention or control group . Intervention infants were discharged when readiness criteria were met . Based on assessed need , intervention group families received public health nursing and homemaker services for up to 8 weeks . Control infants were discharged to their homes at the discretion of the attending physician . All infants were assessed blindly at age 1 year with the Bayley and Home Observation for Measurement of the Environment ( HOME ) scales . RESULTS There were no group differences in baseline infants ' characteristics or in neonatal complications . Infants in the intervention group were discharged from the hospital at an earlier postconceptional age ( mean + /- SD 36.6 + /- 1.5 weeks vs 37.3 + /- 1.6 weeks ; P Median length of hospital stay ( 23 days vs 31.5 days ) and mean weight at the time of discharge ( 2200 + /- 288 g vs 2275 + /- 301 g ) were lower , but not significantly , for infants in the intervention group . A secondary analysis by birth weight strata ( hospital stay and weight at discharge were realized in infants of 1501 through 2000 g birth weight . The persistence of apneic episodes and need for electronic monitoring prevented earlier discharge of infants of deaths and no group differences in rehospitalization rates , use of ambulatory services , or Bayley scores . Intervention families had significantly higher 1-year HOME scores . Minimum cost of hospital care was $ 873 per day , while the total cost of community-based services averaged $ 626 per infant . CONCLUSIONS A significant reduction in average length of hospital stay was achieved for infants of 1501 through 2000 g birth weight . Earlier discharge of infants weighing apneic episodes and feeding difficulties . A community-based program design ed to provide individualized support and education for families of low birth weight infants was cost-effective and had a positive influence on the home environment",
"OBJECTIVE To compare school performance at age 10 years in a cohort of extremely preterm children and term control subjects and to examine the impact of family composition and stability on performance . STUDY DESIGN Prospect i ve , longitudinal follow-up from birth to 10 years of age of a regional cohort of children born at 24 to 31 weeks of gestational age and sociodemographically matched term control subjects . Family composition , extent of parental care giving , and family moves were tracked sequentially . At 10 years , academic achievement and school performance were ascertained for 118 of 125 ( 94 % ) preterm survivors and 119 of 125 ( 95 % ) term children . RESULTS Term children were more likely to demonstrate optimal school outcome ( appropriate grade level without additional classroom assistance ) than were preterm children ( odds ratio 3.4 , 95 % CI 1.9 - 6.0 ) . Medical complications related to prematurity had little impact on school outcome . Among preterm children , optimal school outcome was significantly associated with increased parental education , child rearing by 2 parents ( regardless of marital status ) , and stability in family composition and geographic residence over 10 years . These environmental influences were less pronounced among term control subjects . CONCLUSION Although preterm children performed less well in school than term children , family factors were stronger predictors of school performance than were perinatal complications",
"OBJECTIVE To evaluate the effect of early intervention on the intellectual development of the premature infants . METHODS Premature infants at gestational age of 28 - 36.9 weeks were r and omly divided into two groups : intervention and conventional care groups . Normal newborn infants during the same period were included in the control group ( routine care ) . Up to March 1996 , 156 cases were over the age 1.5 - 2 years ( corrected age ) , 52 in the intervention group , 51 in the conventional care group and 53 in the normal control group . Parents were taught to carry out the 0 - 2 year intervention program , which included motor , cognitive , speech development and social behavior . Every three months , height , weight and head circumference were measured . At the age of one and a half and two years , all infants in the three groups received infant development tests of Child Development Center of China ( CDCC ) scale . The examiner did not know which infant had received intervention . RESULTS There was no significant difference in biological factors among the two premature groups and in cultural and social factors among the three groups . Intelligence tests at the age of one and a half and two years showed that the average mental development index ( MDI ) in the intervention group was 13.8 and 14.6 higher than those in the conventional care group and the differences were significant . The psychomotor development index ( PDI ) was 5.2 and 4.7 higher but the differences were not significant . The MDI and PDI in the intervention group and normal control were quite close , but at two years , the MDI and PDI in the intervention group were 5.7 and 7.3 higher than those in the normal control and the differences were significant ( P MDI in conventional care group at one and a half and two years of age were 11.5 and 8.9 lower . The difference was very significant . There were four cases of mental retardation , whose mental development index ( MDI ) was less then 70 in the conventional care group , but none in the intervention group . CONCLUSIONS Early intervention can promote intellectual development of the premature infants and may be beneficial to the prevention of mental retardation . Early and intensive intervention can produce better results . Bringing parent 's initiative into full play through deepening their underst and ing of the importance of early intervention is the key to success",
"OBJECTIVE To describe the mental and emotional well-being of children born at different birth weights assessed at school age and to identify neonatal , intervening health , and sociodemographic and environmental factors associated with mental and emotional well-being . METHODS To address this issue , we used a prospect i ve cohort study involving two previously studied cohorts , which were recontacted at 8 to 10 years of age to provide a multisite sample of 247 children weighing 1000 g or less at birth , 364 weighing 1001 to 1500 g , 724 weighing 1501 to 2500 g , and 533 weighing more than 2500 g. Maternal reports were obtained on three st and ardized measures of mental and emotional well-being ( the R and General Well-being Scale , the Behavior Problem Index , and the Harter Scale of Child Competence ) and on intervening health , sociodemographic , and environmental variables . Neonatal variables were derived from records at birth . Statistical techniques included analysis of variance and ordinary least squares multiple regression . RESULTS Lower birth weight children did not differ on the General Well-being Scale but were more likely to have behavior problems and to be considered less competent . Other important correlates of mental and emotional well-being included childhood illness , maternal mental health , home environment score , and exposure to household cigarette smoking . CONCLUSION Although lower birth weight children have poorer mental and emotional well-being , a substantial portion of this adverse outcome reflects modifiable environmental factors",
"We investigated the effects of a year-long home intervention with a sample of preterm infants r and omly assigned to 1 of 3 groups : a developmental intervention , a parent-infant intervention , and a no-treatment control group . A full-term no-treatment control was also used . Both intervention approaches focused on the parent-child unit , providing training for parents to improve observational skills , emotional support , and information about community re sources . However , whereas specific tasks to facilitate the child 's development were provided in the developmental intervention group , the quality of the parent-infant interaction was the target for treatment in the other group . All infants were assessed at 4 , 8 , 12 , and 16 months of age corrected for prematurity . The results suggest that although both intervention approaches were effective in modifying some aspects of the home environment and , to a lesser degree , in improving infants ' cognitive development , the parent-infant interaction approach seemed to have the greater impact . These findings confirm previous observations regarding the cognitive development of preterm and full-term infants during the first 18 months of life and demonstrate changes in behavior and behavior styles in both pre- and full-term infants as they become older",
" Twenty-four low birth weight children who had received an experimental intervention ( LBWE ) during the neonatal period , 31 control children who had received no treatment ( LBWC ) , and 36 normal birth weight children were compared . The intervention involved seven hospital sessions and four home sessions in which a nurse helped mothers adapt to their LBW babies . At age 9 , LBWE children scored significantly higher than LBWC children on the Kaufman Mental Processing Composite , Sequential , Simultaneous , Achievement , Arithmetic , and Riddles scales , after statistical adjustments for socioeconomic status . The LBWE children had also advanced more rapidly in school than had LBWC children . Parent ( Child Behavior Checklist ) and teacher ( Teacher 's Report Form ) ratings of school functioning were more favorable for LBWE than LBWC children , with especially strong effects on Teacher 's Report Form scores for academic performance and the attention problems syndrome . At age 9 , LBWE children were not significantly inferior to normal birth weight children on any measure . These results bear out a progressive divergence between the LBWE and LBWC children that first became statistically significant in cognitive scores at age 3 . The findings suggest that the intervention prevented cognitive lags among LBW children and that this eventually had a favorable effect on academic achievement , behavior , and advancement in school . The progression from no significant differences between LBWE and LBWC children on early cognitive and achievement scores to significant and pervasive differences in later functioning argues for long-term follow-up periods to evaluate properly the power of behavioral interventions to compensate for biological risks",
"Thirty-seven infants with severe central nervous system injury or extreme prematurity were r and omly assigned to a multisensory ( auditory-tactile-visual-vestibular ) intervention or control group . Intervention began in the hospital at 33 weeks ' postconceptional age and continued twice daily in the home until 2 months ' corrected age . Mother-infant interactions during feedings were videotaped , and the Bayley Scales of Infant Development were administered . Control mothers stimulated their infants more during feeding , but these significant differences dissipated by 4 months . The presence of periventricular leukomalacia was associated with significantly poorer mental development , regardless of group assignment . Experimental infants tended to exhibit better motor and mental performance and had 23 % fewer cerebral palsy diagnoses at 1 year , but these trends were not statistically significant . The type of brain injury was more important in determining 1-year developmental outcome than type of postnatal experience , suggesting that periventricular leukomalacia presents a major challenge for infant development . ( J Child Neurol 2001;16:493 - 498 )",
"Purpose : To determine the safety and effects on healthy preterm infants of three continuous hours of kangaroo care ( KC ) compared to st and ard NICU care by measuring cardiorespiratory and thermal responses . Design : R and omized controlled trial — pretest-test-posttest control group design . Sample : Twenty-four healthy preterm infants ( 33–35 weeks gestation at birth ) nearing discharge . Eleven of the infants received KC ; 13 received st and ard NICU care . Main Outcome Variables : Heart rate , respiratory rate , oxygen saturation , and abdominal skin temperature were manually recorded every minute . Apnea , bradycardia , periodic breathing , and regular breathing were captured continuously on a pneumocardiogram printout . Three consecutive interfeeding intervals ( three hours each ) on one day constituted the pretest , test , and posttest periods . Results : Mean cardiorespiratory and temperature outcomes remained within clinical ly acceptable ranges during KC . Apnea , bradycardia , and periodic breathing were absent during KC . Regular breathing increased for infants receiving KC compared to infants receiving st and ard NICU care",
"OBJECTIVE . Beneficial effects of breast milk on cognitive skills and behavior ratings have been demonstrated previously in term and very low birth weight infants . Extremely low birth weight infants are known to be at increased risk for developmental and behavior morbidities . The benefits of breast milk that is ingested in the NICU by extremely low birth weight infants on development and behavior have not been evaluated previously . METHODS . Nutrition data including enteral and parenteral feeds were collected prospect ively , and follow-up assessment s of 1035 extremely low birth weight infants at 18 months ’ corrected age were completed at 15 sites that were participants in the National Institute of Child Health and Human Development Neonatal Research Network Glutamine Trial between October 14 , 1999 , and June 25 , 2001 . Total volume of breast milk feeds ( mL/kg per day ) during hospitalization was calculated . Neonatal characteristics and morbidities , interim history , and neurodevelopmental and growth outcomes at 18 to 22 months ’ corrected age were assessed . RESULTS . There were 775 ( 74.9 % ) infants in the breast milk and 260 ( 25.1 % ) infants in the no breast milk group . Infants in the breast milk group were similar to those in the no breast milk group in every neonatal characteristic and morbidity , including number of days of hospitalization . Mean age of first day of breast milk for the breast milk infants was 9.3 ± 9 days . Infants in the breast milk group began to ingest non – breast milk formula later ( 22.8 vs 7.3 days ) compared with the non – breast milk group . Age at achieving full enteral feeds was similar between the breast milk and non – breast milk groups ( 29.0 ± 18 vs 27.4 ± 15 ) . Energy intakes of 107.5 kg/day and 105.9 kg/day during the hospitalization did not differ between the breast milk and non – breast milk groups , respectively . At discharge , 30.6 % of infants in the breast milk group still were receiving breast milk . Mothers in the breast milk group were significantly more likely to be white ( 42 % vs 27 % ) , be married ( 50 % vs 30 % ) , have a college degree ( 22 % vs 6 % ) , and have private health insurance ( 34 % vs 18 % ) compared with the no breast milk group . Mothers who were black , had a low household income ( ≤$20000 ) , or had higher parity were less likely to provide breast milk feeds . The analysis of outcomes between the any human milk and no human milk groups were adjusted for maternal age , maternal education , marital status , race/ethnicity , and the other st and ard covariates . Children in the breast milk group were more likely to have a Bayley Mental Development Index ≥85 , higher mean Bayley Psychomotor Development Index , and higher Bayley Behavior Rating Scale percentile scores for orientation/engagement , motor regulation , and total score . There were no differences in the rates of moderate to severe cerebral palsy or blindness or hearing impairment between the 2 study groups . There were no differences in the mean weight ( 10.4 kg vs 10.4 kg ) , length ( 80.5 cm vs 80.5 cm ) , or head circumference ( 46.8 cm vs 46.6 cm ) for the breast milk and no breast milk groups , respectively , at 18 months . Multivariate analyses , adjusting for confounders , confirmed a significant independent association of breast milk on all 4 primary outcomes : the mean Bayley ( Mental Development Index , Psychomotor Development Index , Behavior Rating Scale , and incidence of rehospitalization ) . For every 10-mL/kg per day increase in breast milk ingestion , the Mental Development Index increased by 0.53 points , the Psychomotor Development Index increased by 0.63 points , the Behavior Rating Scale percentile score increased by 0.82 points , and the likelihood of rehospitalization decreased by 6 % . In an effort to identify a threshold effect of breast milk on Bayley Mental Development Index and Psychomotor Development Index scores and Behavior Rating Scale percentile scores , the mean volume of breast milk per kilogram per day during the hospitalization was calculated , and infants in the breast milk group were divided into quintiles of breast milk ingestion adjusted for confounders . Overall , the differences across the feeding quintiles of Mental Development Index and Psychomotor Development Index were significant . There was a 14.0 % difference in Behavior Rating Scale scores between the lowest and highest quintiles . For the outcomes ( Mental Development Index , Psychomotor Development Index , Behavior Rating Scale , and Rehospitalization , only the values for the > 80th percentile quintile of breast milk feeding were significantly different from the no breast milk values . In our adjusted regression analyses , every 10 mL/kg per day breast milk contributed 0.53 points to the Bayley Mental Development Index ; therefore , the impact of breast milk ingestion during the hospitalization for infants in the highest quintile ( 110 mL/kg per day ) on the Bayley Mental Development Index would be 10 × 0.53 , or 5.3 points . CONCLUSIONS . An increase of 5 points potentially would optimize outcomes and decrease costs by decreasing the number of very low birth weight children who require special education services . The societal implication s of a 5-point potential difference ( one third of an SD ) in IQ are substantial . The potential long-term benefit of receiving breast milk in the NICU for extremely low birth weight infants may be to optimize cognitive potential and reduce the need for early intervention and special education services"
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BACKGROUND With the advancement in information technology and mobile internet , digital health interventions ( DHIs ) are improving the care of cardiovascular diseases ( CVDs ) . The impact of DHIs on cost-effective management of CVDs has been examined using the decision analytic model-based health technology assessment approach . OBJECTIVE The aim of this study was to perform a systematic review of the decision analytic model-based studies evaluating the cost-effectiveness of DHIs on the management of CVDs . METHODS A literature review was conducted in Medline , Embase , Cumulative Index to Nursing and Allied Health Literature Complete , PsycINFO , Scopus , Web of Science , Center for Review and Dissemination , and Institute for IEEE Xplore between 2001 and 2018 . Studies were included if the following criteria were met : ( 1 ) English articles , ( 2 ) DHIs that promoted or delivered clinical interventions and had an impact on patients ' cardiovascular conditions , ( 3 ) studies that were modeling works with health economic outcomes of DHIs for CVDs , ( 4 ) studies that had a comparative group for assessment , and ( 5 ) full economic evaluations including a cost-effectiveness analysis , cost-utility analysis , cost-benefit analysis , and cost-consequence analysis . The primary outcome collected was the cost-effectiveness of the DHIs , presented by incremental cost per additional quality -adjusted life year ( QALY ) . The quality of each included study was evaluated using the Consoli date d Health Economic Evaluation Reporting St and ards . RESULTS A total of 14 studies met the defined criteria and were included in the review . Among the included studies , heart failure ( 7/14 , 50 % ) and stroke ( 4/14 , 29 % ) were two of the most frequent CVDs that were managed by DHIs . A total of 9 ( 64 % ) studies were published between 2015 and 2018 and 5 ( 36 % ) published between 2011 and 2014 . The time horizon was ≤1 year in 3 studies ( 21 % ) , > 1 year in 10 studies ( 71 % ) , and 1 study ( 7 % ) did not declare the time frame . The types of devices or technologies used to deliver the health interventions were short message service ( 1/14 , 7 % ) , telephone support ( 1/14 , 7 % ) , mobile app ( 1/14 , 7 % ) , video conferencing system ( 5/14 , 36 % ) , digital transmission of physiologic data ( telemonitoring ; 5/14 , 36 % ) , and wearable medical device ( 1/14 , 7 % ) . The DHIs gained higher QALYs with cost saving in 43 % ( 6/14 ) of studies and gained QALYs at a higher cost at acceptable incremental cost-effectiveness ratio ( ICER ) in 57 % ( 8/14 ) of studies . The studies were classified as excellent ( 0/14 , 0 % ) , good ( 9/14 , 64 % ) , moderate ( 4/14 , 29 % ) , and low ( 1/14 , 7 % ) quality . CONCLUSIONS This study is the first systematic review of decision analytic model-based cost-effectiveness analyses of DHIs in the management of CVDs . Most of the identified studies were published recently , and the majority of the studies were good quality cost-effectiveness analyses with an adequate duration of time frame . All the included studies found the DHIs to be cost-effective | [
"Abstract Aims Haemodynamic‐guided heart failure ( HF ) management effectively reduces decompensation events and need for hospitalizations . The economic benefit of clinical improvement requires further study . Methods and results An estimate of the cost‐effectiveness of haemodynamic‐guided HF management was made based on observations published in the r and omized , prospect i ve single‐blinded CHAMPION trial . A comprehensive analysis was performed including healthcare utilization event rates , survival , and quality of life demonstrated in the r and omized portion of the trial ( 18 months ) . Markov modelling with Monte Carlo simulation was used to approximate comprehensive costs and quality ‐adjusted life years ( QALYs ) from a payer perspective . Unit costs were estimated using the Truven Health MarketScan data base from April 2008 to March 2013 . Over a 5‐year horizon , patients in the Treatment group had average QALYs of 2.56 with a total cost of US$ 56 974 ; patients in the Control group had QALYs of 2.16 with a total cost of US$ 52 149 . The incremental cost‐effectiveness ratio ( ICER ) was US$ 12 262 per QALY . Using comprehensive cost modelling , including all anticipated costs of HF and non‐HF hospitalizations , physician visits , prescription drugs , long‐term care , and outpatient hospital visits over 5 years , the Treatment group had a total cost of US$ 212 004 and the Control group had a total cost of US$ 200 360 . The ICER was US$ 29 593 per QALY . Conclusions St and ard economic modelling suggests that pulmonary artery pressure‐guided management of HF using the CardioMEMS ™ HF System is cost‐effective from the US‐payer perspective . This analysis provides the background for further modelling in specific country healthcare systems and cost structures",
"Objective To estimate the cost-effectiveness of Tobacco , Exercise and Diet Messages ( TEXT ME ) , a text message-based intervention that provides advice , motivation , information and support to improve health-related behaviours . Methods A lifetime Markov model was used to estimate major vascular events ( myocardial infa rct ions and strokes ) avoided , quality -adjusted life years ( QALYs ) gained , costs to the health system and the incremental cost per QALY gained . The model was informed by data from a r and omised controlled trial of TEXT ME , with evidence from systematic review s and meta-analyses used to estimate the effects of changes in risk factors on the risk of major vascular events . Expected costs and health outcomes were estimated with uncertainty surrounding these characterised using probabilistic sensitivity analysis and a number of scenario analyses . Results For a target population of 50 000 patients with documented coronary heart disease , the intervention is expected to lead to 563 fewer myocardial infa rct ions , 361 fewer strokes and 1143 additional QALYs . TEXT ME is expected to lead to an overall saving of $ 10.56 million for the health system over the patients ’ lifetimes . The intervention can therefore be considered cost-saving and health-improving . Neither parameter nor structural uncertainty had a significant impact on the conclusion that TEXT ME is cost-effective . Conclusions The provision of TEXT ME is predicted to lead to better health outcomes and an overall saving in costs for the health system . Trial registration number anzctr.org.au identifier : ACTRN12611000161921"
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PURPOSE To review systematic ally the literature on fall risk factors for young patients affected by neurological disorders . METHOD A systematic search of all primary research -based literature on risk factors for falls or fall characteristics in young adults ( mean age was conducted using 11 data bases . Studies that focused on fall risk screening tools , fear of falling or interventions for fall prevention were excluded . Two review ers independently agreed on eligibility and method ological quality and extracted data . RESULTS Twenty-three final studies were selected , including 21 observational studies ; one r and omised controlled trial and one qualitative study . An average of 50.2 % of the 2776 total participants experienced at least one fall . Among the multiple risk factors studied , a reduced performance in balance and gait was consistently associated with falls , while the contribution of single physical and cognitive impairments was variable in different population s. Walking aids , wheelchair characteristics and environmental hazards are significant environmental risk factors . The heterogeneity of the assessment tools used to measure risk factors limited comparison across studies . CONCLUSION Falling is a common problem among young patients affected by neurological disorders , although the risk of falling for a specific individual is difficult to predict and the risk of a severe fall-related injury has not yet been established . IMPLICATION S FOR REHABILITATION Young patients with impaired gait and balance or medium to severe motor disability appear to be at increased risk of falling . Patients who are relatively independent and still participating in challenging activities have an increased exposure to fall-risk . Walking aids , wheelchair characteristics and environmental hazards are significant environmental risk factors . These risk factors should be monitored closely in the young neurological population to help prevent falls | [
"Study design : A prospect i ve study . Objectives : To evaluate the changes of functional abilities , incidences of complications and falls of patients with spinal cord injury ( SCI ) 6 months after discharge . Setting : A major tertiary referral hospital , Thail and . Methods : Forty-four patients with SCI completed the study . Their average age and post-injury time were 45.23±13.78 years and 51.52±47.87 months respectively . Functional abilities of the subjects were measured by using the Spinal Cord Independence Measure II ( SCIM II ) . Incidences of complications and falls were prospect ively assessed every month by using a question naire . Results : After 6 months , the SCIM II scores of subjects showed a slight decrease ( 58.60±21.22–58.37±22.06 scores ) . The significant decrement was illustrated in self-care and mobility scores of subjects with chronic motor incomplete SCI ( P medical complication ( range 1–5 times ) which 11 of them had to re-admit for 3–30 days . Twenty-four subjects sustained at least one fall in 6 months ( range 1–24 times ) which one subject had metatarsal bone fracture after fall . Conclusion : The functional ability of subjects with SCI , particularly those with chronic motor incomplete SCI , significantly decreased after discharge . The subjects also encountered a high risk of complications and falls that might associate with the decrement of functional ability . The findings confirmed important roles of community rehabilitation after discharge",
"Elderly individuals with AD are more susceptible to falls , which might be associated with decrements in their executive functions and balance , among other things . We aim ed to analyze the effects of a program of dual task physical activity on falls , executive functions and balance of elderly individuals with AD . We studied 21 elderly with probable AD , allocated to two groups : the training group ( TG ) , with 10 elderly who participated in a program of dual task physical activity ; and the control group ( CG ) , with 11 elderly who were not engaged in regular practice of physical activity . The Clock Drawing Test ( CDT ) and the Frontal Assessment Battery ( FAB ) were used in the assessment of the executive functions , while the Berg Balance Scale ( BBS ) and the Timed Up- and -Go (TUG)-test evaluated balance . The number of falls was obtained by means of a question naire . We observed a better performance of the TG as regards balance and executive functions . Moreover , the lower the number of steps in the TUG scale , the higher the scores in the CDT , and in the FAB . The practice of regular physical activity with dual task seems to have contributed to the maintenance and improvement of the motor and cognitive functions of the elderly with AD",
"We conducted a retrospective case-control study of falls over a four year period on a 30 bed neurorehabilitation unit at the Burke Rehabilitation Hospital to characterize the nature of falls and identify factors associated with falling . The most common diagnoses treated on the unit were traumatic spinal cord injury , brain injury , and multiple sclerosis ; stroke patients are treated on another service . Falls represented 72 percent of all incident reports made to the Nursing Office during the study period . One hundred seventeen ( 117 ) falls occurred in 82 patients during a time when the unit census was 28,622 patient days , yielding a rate of 1,439 falls per 1,000 patient years . One hundred fourteen ( 114 ) patients admitted with no history of falling during the same period were selected r and omly for comparison . Most falls were associated with no injury ( n = 96 ) or minor injury ( n = 18 ) . The most significant injuries occurred in three cases with lacerations requiring sutures . Falls occurred with greatest frequency during the first and fourth quartiles of the hospital stay , during the evening and while bed transfers were being performed . No association between falling and patient age , sex , diagnosis , number of medications , use of sedating medications , presence of motor , visual or cognitive impairment or orthostatic hypotension was evident . An increased risk of falling was associated with physician orders for Posey restraints . The implication of these findings for falls prevention programs is discussed",
"OBJECTIVE To identify measures of balance , gait , and strength that predict falls in women with multiple sclerosis ( MS ) . DESIGN This prospect i ve study followed participants for 1 year . SETTING University research laboratories . PARTICIPANTS A convenience sample of women with MS ( N=99 ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Balance was assessed with the limits of stability ( LOS ) test and the Sensory Organization Test . Peak force , torque , and power of knee flexors and extensors as well as hip abductors and adductors were also measured . Temporal-spatial parameters of gait were measured by an instrumented walkway system . For 1 year after baseline assessment s , the participants reported their falls . Participants were then classified based on the number of reported falls for use in logistic regression models to predict either people with at least 1 fall or people with at least 2 falls ( recurrent fallers ) . RESULTS A total of 159 falls were reported by 48 % of the participants . Exp and ed Disability Status Scale scores , leaning forward to the LOS , and st and ing sway within a visually referenced surround significantly predicted people with at least 1 fall as well as recurrent fallers . Stance-phase asymmetries and base-of-support width during gait , as well as the force and power produced during leg extension or flexion additionally predicted recurrent fallers . The models ' overall predictive accuracy ranged from 69 % to 85 % . CONCLUSIONS This prospect i ve study confirmed the prevalence and multifactorial nature of falls in this MS sample . In addition to advancing disease status , impaired forward LOS and visually dependent sway ( as well as gait asymmetries and leg flexor-extensor weakness for recurrent fallers ) predict future falls in women with MS",
"Objective : To investigate accidental falls and near fall incidents in people with multiple sclerosis with respect to clinical variables and the predictive values of four tests . Design : A longitudinal , multi-centred cohort study with prospect ively collected falls . Procedures : Self-reported incidents during the three months following a st and ardized test procedure . Subjects : Seventy-six people with multiple sclerosis and an Exp and ed Disability Status Scale score between 3.5 and 6.0 . Main outcome measures : Berg Balance Scale , Timed Up and Go cognitive , Four Square Step Test ( FSST ) and 12-item Multiple Sclerosis Walking Scale . Results : Forty-eight people ( 63 % ) registered 270 falls . Most falls occurred indoors during activities of daily life . We found a correlation of rs=0.57 between near falls and falls , and of rs = 0.82 between registered and retrospectively recalled falls . Fallers and non-fallers differed significantly regarding Exp and ed Disability Status Score ( odds ratio ( OR ) 1.99 , 95 % confidence interval ( CI ) 1.22 ; 3.40 ) , spasticity ( OR 1.14 , CI 1.02 ; 1.31 ) , proprioception ( OR 2.50 , CI 1.36 ; 5.12 ) and use of walking aids ( OR 2.27 , CI 1.23 ; 4.37 ) . Reported use of walking aids both indoors and outdoors increased the odds of falling fivefold while disturbed proprioception increased the odds 2.5—15.6 times depending on severity . The odds of falling were doubled for each degree of increased Exp and ed Disability Status Score and more than doubled for each degree of increased spasticity . The Berg Balance Scale , use of walking aids and Timed Up and Go cognitive best identified fallers ( 73—94 % ) and proprioception , Exp and ed Disability Status Score , 12-item Multiple Sclerosis Walking Scale and Four Square Step Test best identified non-fallers ( 75—93 % ) . Conclusions : In clinical practice , looking at the use of walking aids , investigating proprioception and spasticity , rating Exp and ed Disability Status Score and using Berg Balance Scale or Timed Up and Go cognitive all contribute when identifying fallers",
"Background There is a lack of information concerning the relation between objective measures of gait and balance and fall history in persons with MS ( PwMS ) . This investigation assessed the relation between demographic , clinical , mobility and balance metrics and falls history in persons with multiple sclerosis ( MS ) . Methods 52 ambulatory persons with MS ( PwMS ) participated in the investigation . All persons provided demographic information including fall history over the last 12 months . Disease status was assessed with Exp and ed Disability Status Scale ( EDSS ) . Walking speed , coordination , endurance and postural control were quantified with a multidimensional mobility battery . Results Over 51 % of the participants fell in the previous year with 79 % of these people being suffering recurrent falls . Overall , fallers were older , had a greater prevalence of assistive devices use , worse disability , decreased walking endurance , and greater postural sway velocity with eyes closed compared to non-fallers . Additionally , fallers had greater impairment in cerebellar , sensory , pyramidal , and bladder/bowel subscales of the EDSS . Conclusions The current observations suggest that PwMS who are older , more disabled , utilize an assistive device , have decreased walking coordination and endurance and have diminished balance have fallen in the previous year . This suggests that individuals who meet these criteria need to be carefully monitored for future falls . Future research is needed to determine a prospect i ve model of falls specific to PwMS . Additionally , the utility of interventions aim ed at reducing falls and fall risk in PwMS needs to be established",
"BACKGROUND Cognition influences gait and balance in elderly people . Executive functions seem to play a key role in this mechanism . Previous studies used only a single test to probe executive functions , and outcome measures were restricted to gait variables . We extend this prior work by examining the association between two different executive functions and measures of both gait and balance , with and without two different cognitive dual tasks . METHODS This is a cross-sectional study with r and omly selected community-living elderly people . Executive functions were tested with the Trail Making Test Parts A and B and the Stroop Color Word Test ; memory with Cambridge Neuropsychological Test Automated Battery ( CANTAB ) subtests . Patients walked without and with two dual tasks ( subtracting serial sevens and animal naming ) . Main outcomes focused on gait ( velocity , stride length , and stride time variability ) , measured on an electronic walkway , and balance , measured as trunk movements during walking . Associations were assessed with multiple regression models . RESULTS One hundred elderly people , with a mean age 80.6 years ( range 75 - 93 years ) participated . Both dual tasks decreased gait velocity and increased variability and trunk sway . Executive functions were associated with only stride length variability and mediolateral trunk sway during performance of animal naming as the dual task . Memory was not associated with the gait and balance variables . CONCLUSIONS In community-living elderly people , executive functions are associated with gait and balance impairment during a challenging dual-task condition that also depends on executive integrity . Next steps will be to explore the value of executive functions in defining fall-risk profiles and in fall-prevention interventions for frail patients",
"Abstract Background / Objective : To determine factors associated with falls among a sample of ambulatory individuals with incomplete spinal cord injury ( SCI ) . Study Design : Cross-sectional mail survey . Methods : A survey instrument of participant characteristics and fall-related variables was developed using relevant items from existing measures and was mailed to 221 individuals with incomplete SCI , who were identified from records of a large specialty hospital in the southeastern United States . Of the 221 prospect i ve participants , 119 completed the question naire ( 54 % ) . Multivariable logistic regression models were used to determine factors that were independently associated with having had a fall in the past year . Results : After adjusting for covariates , having fallen in the past year was significantly ( P greater numbers of medical conditions ( odds ratio [ OR ] = 1.3 ; 95 % confidence interval [ Cl ] = 1.0 - 1.7 ) , having arthritis ( OR = 3.4 , 95 % Cl = 1.2 - 9.6 ) , experiencing dizziness ( OR = 5.6 , 95 % Cl = 1.1 - 27.7 ) , greater numbers of days with poor physical health ( OR = 1.1 ; 95 % Cl = 1.0 - 1.3 ) , and the restriction of community activities because of fear of falling ( OR = 1.5 , 95 % Cl = 1.1 - 2.1 ) . The multivariable models also showed that the odds of having fallen were significantly lower among those with better current perceived physical health ( OR = 0.5 ; 95 % Cl = 0.3 - 0.9 ) , those with better perceived health compared to a year ago ( OR = 0.4 ; 95 % Cl = 0.2 - 0.8 ) , individuals who exercised more frequently ( OR = 0.2 ; 95 % Cl = 0.1 - 0.7 ) , and those who used a walker ( OR = 0.3 ; 95 % CI = 0.1 - 0.9 ) . Conclusions : Results suggest that interventions that address exercise frequency , walker use , and dizziness have promise for reducing falls for individuals with incomplete SCI",
"OBJECTIVES ( 1 ) To determine the incidence of wheelchair falls and fall-related injuries in persons with spinal cord injury ( SCI ) living in the community . ( 2 ) To predict wheelchair-related falls and associated injuries from specific parameters including characteristics of the wheelchair user , wheelchair type and features , health care practice s , wheelchair activities , and physical environment . DESIGN This prospect i ve cohort study followed participants monthly over 1 year ; data were collected through surveys , interviews , performance testing , observation , and medical records . SETTING Three Veterans ' Administration hospitals . PARTICIPANTS Convenience sample of community-dwelling persons with SCI who used a wheelchair as their primary means of mobility ( N=702 ) . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Self-reports of wheelchair falls and fall-related injuries , Wheelchair User Characteristics Survey , Health Status Checklist , Health-Related Behaviors , Zuckerman Sensation Seeking Scale , Wheelchair and Equipment-Related Behaviors , Wheelchair Characteristics , Wheelchair Skills Test , and Physical Environment Assessment . RESULTS Of the 659 subjects who completed the study , 204 participants ( 31 % ) reported 553 fall events , and 95 subjects ( 14 % ) were injured as a result of wheelchair falls . A logistic regression model for predicting wheelchair falls identified 6 significant risk factors : pain in previous 2 months , alcohol abuse , greater motor function , history of previous fall , fewer SCI years , and shorter length of wheelchair . Eighty-two percent of the variance for wheelchair fall events was explained by these 6 variables . A logistic regression model for predicting injurious falls identified 4 significant risk factors : pain in previous 2 months , greater motor function , history of previous fall , and inaccessible home entrance . These 4 factors were able to explain 81 % of the variance for injurious falls . CONCLUSIONS This is the first study to determine the incidence of wheelchair-related falls in community-dwelling people with SCI who use a wheelchair . Results indicate the incidence of falls was 31 % and injurious falls was 14 % . Those at greatest risk can be predicted from some readily available information regarding their clinical status , wheelchair features , and home environment",
"There are few functionally meaningful clinical measures used to guide management of patients with ALS . Falls are common , can be debilitating , and result in increased health care costs . We assessed the performance and ability to predict falls of the Timed Up and Go ( TUG ) test , which quantifies walking ability , in a prospect i ve longitudinal study . Thirty‐one patients underwent six monthly TUG , ALSFRS‐R , forced vital capacity , muscle testing ( MMT ) and quality of life assessment s. Linear and generalized linear mixed effects models assessed the associations among variables and ability to predict falls . The increase in TUG time was linear over six months , and TUG time was negatively associated with ALSFRS‐R ( p⩽0.001 ) and MMT scores ( p⩽0.001 ) . The TUG test was the only variable that was associated with the chance of falling ( p = 0.024 ) ; patients with TUG times of 14 s had a 10 % chance of falling during the study . In conclusion , TUG performance declined linearly in this longitudinal study , was correlated with st and ard outcome measures , and predicted falls . The TUG test can guide management of patients with ALS ; a time of 14 s can be used to prompt the recommendation for mobility aids to prevent falls",
"Background . Persons with spinal cord injury who are able to walk are at risk for falls . Objective . The objectives were to investigate if the Berg Balance Scale ( BBS ) can discriminate those with a propensity to fall ; to determine whether the BBS is associated with mobility measures , fear of falling , and muscle strength ; and to assess interobserver reliability . Methods . The measurement tools used were the BBS , the Spinal Cord Independence Measure , the Falls Efficacy Scale ( FES-I ) , the Walking Index for Spinal Cord Injury , the 10-m walk test , and the st and ard neurological classification including motor scores ( MS ) . Falls were recorded retrospectively for the previous month and prospect ively for the subsequent 4 months . To determine interobserver reliability , BBS performance was videotaped and analyzed by additional physical therapists . Associations between BBS and the number of falls , measures of mobility , FES-I , and MS were calculated using Spearman correlations . The interobserver reliability was quantified using Kendall ’s coefficient of concordance and intraclass correlation coefficients ( ICCs ) . Results . Forty-two participants were included of whom 26 sustained 1 or more falls . BBS performance correlated with measures of mobility , FES-I , and MS ( rs = -.83 to .93 ; P number of falls ( rs = -.17 ; P = .28 ) . The interobserver reliability was excellent , both for single items ( .84-.98 , P BBS proved to be reliable and to relate well with other mobility measures , fear of falling , and muscle strength . However , it was unable discriminate between people who did fall and people who did not fall",
"Background . Quantitative posturography has been reported as a reliable tool to measure balance in people with multiple sclerosis ( MS ) . However , data on its diagnostic accuracy in predicting the occurrence of falls are lacking . Objective . To determine sensitivity , specificity , predictive values , and accuracy of posturography in detecting falls in MS subjects over a 3-month follow-up period . Methods . One hundred consecutive patients with MS were tested by the Berg Balance Scale ( BBS ) and by static posturography on a monoaxial platform . Participants recorded the occurrence of accidental falls for the next 3 months . Abnormal cutoff values for static st and ing balance measures were set at 2 st and ard deviations above the mean values obtained from 50 healthy controls ( HC ) . The diagnostic accuracy of the BBS and static posturography was analyzed with respect to the prospect ively collected data on the occurrence of falls . Results . Posturometric measures in participants with MS were significantly worse than in HC ( all P values center of pressure ( COP ) path with open eyes condition had substantial test – retest reliability . Static posturography was more sensitive ( 88 % vs 37 % ) and accurate ( 75 % vs 63 % ) , but slightly less specific ( 67 % vs 81 % ) , than the BBS in predicting accidental falls . A logistic regression analysis revealed that the worse the COP path , the greater the risk for accidental falls ( odds ratio = 1.08 ; P people with MS who are at risk of accidental falls",
"Falls are common in patients with Huntington 's disease , but the incidence , falling circumstances and contributing factors have never been examined . We recorded falls in 45 early to midstage Huntington 's disease patients , both retrospectively ( 12 months ) and prospect ively ( 3 months ) . Fall rates were related to relevant baseline measures , including the Unified Huntington 's Disease Rating Scale ( UHDRS ) and quantitative measures of balance ( using angular velocity sensors ) and gait ( using a pressure-sensitive walkway ) . Balance and gait measures were compared between patients and 27 healthy age-matched controls . Twenty-seven patients ( 60 % ) reported two or more falls in the previous year and were classified as fallers . During prospect i ve follow-up 40 % reported at least one fall . A high proportion of falls ( 72.5 % ) caused minor injuries . Compared to nonfallers , fallers showed significantly higher scores for chorea , bradykinesia and aggression , as well as lower cognitive scores . Compared to controls , Huntington patients had a decreased gait velocity ( 1.15 m/s versus 1.45 m/s , P decreased stride length ( 1.29 m versus 1.52 m , P stride length variability and a significantly greater trunk sway in medio-lateral direction compared to nonfallers . We conclude that falls are common in Huntington 's disease . Contributing factors include a combination of \" motor \" deficits ( mainly gait bradykinesia , stride variability and chorea , leading to excessive trunk sway ) , as well as cognitive decline and perhaps behavioral changes . These factors should be considered as future targets for therapies that aim to reduce falls in Huntington 's disease"
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Objectives To assess the overall effect of vitamin D supplementation on risk of acute respiratory tract infection , and to identify factors modifying this effect . Design Systematic review and meta‐ analysis of individual participant data ( IPD ) from r and omised controlled trials . Data sources Medline , Embase , the Cochrane Central Register of Controlled Trials , Web of Science , Clinical Trials.gov , and the International St and ard R and omised Controlled Trials Number registry from inception to December 2015 . Eligibility criteria for study selection R and omised , double blind , placebo controlled trials of supplementation with vitamin D3 or vitamin D2 of any duration were eligible for inclusion if they had been approved by a research ethics committee and if data on incidence of acute respiratory tract infection were collected prospect ively and prespecified as an efficacy outcome . Results 25 eligible r and omised controlled trials ( total 11 321 participants , aged 0 to 95 years ) were identified . IPD were obtained for 10 933 ( 96.6 % ) participants . Vitamin D supplementation reduced the risk of acute respiratory tract infection among all participants ( adjusted odds ratio 0.88 , 95 % confidence interval 0.81 to 0.96 ; P for heterogeneity , protective effects were seen in those receiving daily or weekly vitamin D without additional bolus doses ( adjusted odds ratio 0.81 , 0.72 to 0.91 ) but not in those receiving one or more bolus doses ( adjusted odds ratio 0.97 , 0.86 to 1.10 ; P for interaction=0.05 ) . Among those receiving daily or weekly vitamin D , protective effects were stronger in those with baseline 25‐hydroxyvitamin D levels ) . Vitamin D did not influence the proportion of participants experiencing at least one serious adverse event ( adjusted odds ratio 0.98 , 0.80 to 1.20 , P=0.83 ) . The body of evidence contributing to these analyses was assessed as being of high quality . Conclusions Vitamin D supplementation was safe and it protected against acute respiratory tract infection overall . Patients who were very vitamin D deficient and those not receiving bolus doses experienced the most benefit . Systematic review registration PROSPERO CRD42014013953 | [
"BACKGROUND Low serum 25-hydroxyvitamin D ( 25-[OH]D ) levels have been associated with lower FEV(1 ) , impaired immunologic control , and increased airway inflammation . Because many patients with chronic obstructive pulmonary disease ( COPD ) have vitamin D deficiency , effects of vitamin D supplementation may extend beyond preventing osteoporosis . OBJECTIVE To explore whether supplementation with high doses of vitamin D could reduce the incidence of COPD exacerbations . DESIGN R and omized , single-center , double-blind , placebo-controlled trial . ( Clinical Trials.gov registration number : NCT00666367 ) SETTING University Hospitals Leuven , Leuven , Belgium . PATIENTS 182 patients with moderate to very severe COPD and a history of recent exacerbations . INTERVENTION 100,000 IU of vitamin D supplementation or placebo every 4 weeks for 1 year . MEASUREMENTS The primary outcome was time to first exacerbation . Secondary outcomes were exacerbation rate , time to first hospitalization , time to second exacerbation , FEV(1 ) , quality of life , and death . RESULTS Mean serum 25-(OH)D levels increased significantly in the vitamin D group compared with the placebo group ( mean between-group difference , 30 ng/mL [ 95 % CI , 27 to 33 ng/mL ] ; P median time to first exacerbation did not significantly differ between the groups ( hazard ratio , 1.1 [ CI , 0.82 to 1.56 ] ; P = 0.41 ) , nor did exacerbation rates , FEV(1 ) , hospitalization , quality of life , and death . However , a post hoc analysis in 30 participants with severe vitamin D deficiency ( serum 25-[OH]D levels exacerbations in the vitamin D group ( rate ratio , 0.57 [ CI , 0.33 to 0.98 ] ; P = 0.042 ) . LIMITATION This was a single-center study with a small sample size . CONCLUSION High-dose vitamin D supplementation in a sample of patients with COPD did not reduce the incidence of exacerbations . In participants with severe vitamin D deficiency at baseline , supplementation may reduce exacerbations . PRIMARY FUNDING SOURCE Applied Biomedical Research Program , Agency for Innovation by Science and Technology ( IWT-TBM )",
"RATIONALE Restoration of vitamin D sufficiency may reduce asthma exacerbations , events that are often associated with respiratory tract infections and cold symptoms . OBJECTIVES To determine whether vitamin D supplementation reduces cold symptom occurrence and severity in adults with mild to moderate asthma and vitamin D insufficiency . METHODS Colds were assessed in the AsthmaNet VIDA ( Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness ) trial , in which 408 adult patients were r and omized to receive placebo or cholecalciferol ( 100,000 IU load plus 4,000 IU/d ) for 28 weeks as add-on therapy . The primary outcome was cold symptom severity , which was assessed using daily scores on the 21-item Wisconsin Upper Respiratory Symptom Survey . MEASUREMENTS AND MAIN RESULTS A total of 203 participants experienced at least one cold . Despite achieving 25-hydroxyvitamin D levels of 41.9 ng/ml ( 95 % confidence interval [ CI ] , 40.1 - 43.7 ng/ml ) by 12 weeks , vitamin D supplementation had no effect on the primary outcome : the average peak WURSS-21 scores ( 62.0 [ 95 % CI , 55.1 - 68.9 ; placebo ] and 58.7 [ 95 % CI , 52.4 - 65.0 ; vitamin D ] ; P = 0.39 ) . The rate of colds did not differ between groups ( rate ratio [ RR ] , 1.2 ; 95 % CI , 0.9 - 1.5 ) ; however , among African Americans , those receiving vitamin D versus placebo had an increased rate of colds ( RR , 1.7 ; 95 % CI , 1.1 - 2.7 ; P = 0.02 ) . This was also observed in a responder analysis of all subjects achieving vitamin D sufficiency , regardless of treatment assignment ( RR , 1.4 ; 95 % CI , 1.1 - 1.7 ; P = 0.009 ) . CONCLUSIONS Our findings in patients with mild to moderate asthma undergoing an inhaled corticosteroid dose reduction do not support the use of vitamin D supplementation for the purpose of reducing cold severity or frequency",
"Objective To investigate whether vitamin D supplementation can decrease the mortality and morbidity of low birthweight infants in low income countries . Design R and omised controlled trial . Setting Large government hospital in New Delhi , India . Participants 2079 low birthweight infants born at term ( > 37 weeks ’ gestation ) . Main outcome measures Primary outcome was admission to hospital or death during the first six months of life . Main secondary outcome was growth . Interventions Weekly vitamin D supplements for six months at a dose of one recommended nutrient intake per day ( 35 µg/week ) . Infants were visited weekly at home for observed supplementation and were brought to the clinic monthly for clinical examination and anthropometric measurements . Results Between group differences were not significant for death or hospital admissions ( 92 among 1039 infants in the vitamin D group v 99 among 1040 infants in the placebo group ; adjusted rate ratio 0.93 , 95 % confidence interval 0.68 to 1.29 ; P=0.68 ) , or referral to the outpatient clinic for moderate morbidity . Vitamin D supplementation result ed in better vitamin D status as assessed by plasma calcidiol levels at six months . In adjusted analyses , vitamin D treatment significantly increased st and ard deviation ( z ) scores at six months for weight , length , and arm circumference and decreased the proportion of children with stunted growth ( length for age z score ≤2 ) or with arm circumference z scores of 2 or less . Conclusion A weekly dose of vitamin D result ed in better vitamin D status and benefited the classic vitamin D function of bone growth but did not decrease the incidence of severe morbidity or death among young low birthweight infants . Trial registration Clinical Trials.gov NCT00415402",
"Background Low serum levels of 25-hydroxyvitamin D3 are associated with an increased risk of respiratory tract infections ( RTIs ) . Clinical trials with vitamin D3 against various infections have been carried out but data are so far not conclusive . Thus , there is a need for additional r and omised controlled trials of effects of vitamin D3 on infections . Objective To investigate if supplementation with vitamin D3 could reduce infectious symptoms and antibiotic consumption among patients with antibody deficiency or frequent RTIs . Design A double-blind r and omised controlled trial . Setting Karolinska University Hospital , Huddinge . Participants 140 patients with antibody deficiency ( selective IgA subclass deficiency , IgG subclass deficiency , common variable immune disorder ) and patients with increased susceptibility to RTIs ( > 4 bacterial RTIs/year ) but without immunological diagnosis . Intervention Vitamin D3 ( 4000 IU ) or placebo was given daily for 1 year . Primary and secondary outcome measures The primary endpoint was an infectious score based on five parameters : symptoms from respiratory tract , ears and sinuses , malaise and antibiotic consumption . Secondary endpoints were serum levels of 25-hydroxyvitamin D3 , microbiological findings and levels of antimicrobial peptides ( LL-37 , HNP1–3 ) in nasal fluid . Results The overall infectious score was significantly reduced for patients allocated to the vitamin D group ( 202 points ) compared with the placebo group ( 249 points ; adjusted relative score 0.771 , 95 % CI 0.604 to 0.985 , p=0.04 ) . Limitations A single study centre , small sample size and a selected group of patients . The sample size calculation was performed using p=0.02 as the significance level whereas the primary and secondary endpoints were analysed using the conventional p=0.05 as the significance level . Conclusions Supplementation with vitamin D3 may reduce disease burden in patients with frequent RTIs",
"OBJECTIVE : Observational studies suggest that serum levels of 25-hydroxyvitamin D ( 25[OH]D ) are inversely associated with acute respiratory infections ( ARIs ) . We hypothesized that vitamin D supplementation of children with vitamin D deficiency would lower the risk of ARIs . METHODS : By using cluster r and omization , classrooms of 744 Mongolian schoolchildren were r and omly assigned to different treatments in winter ( January – March ) . This analysis focused on a subset of 247 children who were assigned to daily ingestion of unfortified regular milk ( control ; n = 104 ) or milk fortified with 300 IU of vitamin D3 ( n = 143 ) . This comparison was double-blinded . The primary outcome was the number of parent-reported ARIs over the past 3 months . RESULTS : At baseline , the median serum 25(OH)D level was 7 ng/mL ( interquartile range : 5–10 ng/mL ) . At the end of the trial , follow-up was 99 % ( n = 244 ) , and the median 25(OH)D levels of children in the control versus vitamin D groups was significantly different ( 7 vs 19 ng/mL ; P receiving vitamin D reported significantly fewer ARIs during the study period ( mean : 0.80 vs 0.45 ; P = .047 ) , with a rate ratio of 0.52 ( 95 % confidence interval : 0.31–0.89 ) . Adjusting for age , gender , and history of wheezing , vitamin D continued to halve the risk of ARI ( rate ratio : 0.50 [ 95 % confidence interval : 0.28–0.88 ] ) . Similar results were found among children either below or above the median 25(OH)D level at baseline ( rate ratio : 0.41 vs 0.57 ; Pinteraction = .27 ) . CONCLUSIONS : Vitamin D supplementation significantly reduced the risk of ARIs in winter among Mongolian children with vitamin D deficiency",
"OBJECTIVES To determine the efficacy and safety of high-dose vitamin D supplementation for prevention of acute respiratory infection ( ARI ) in older long-term care residents . DESIGN R and omized controlled trial investigating high-dose vs st and ard-dose vitamin D from 2010 to 2014 . SETTING Colorado long-term care facilities . PARTICIPANTS Long-term care residents aged 60 and older ( n = 107 ) . INTERVENTION The high-dose group received monthly supplement of vitamin D3 100,000 IU , the st and ard-dose group received a monthly placebo ( for participants taking 400 - 1,000 IU/d as part of usual care ) or a monthly supplement of 12,000 IU of vitamin D3 ( for participants taking incidence of ARI during the 12-month intervention . Secondary outcomes were falls and fractures , 25-hydroxyvitamin D levels , hypercalcemia , and kidney stones . RESULTS Participants ( 55 high dose , 52 st and ard dose ) were r and omized and included in the final analysis . The high-dose group had 0.67 ARIs per person-year and the st and ard-dose group had 1.11 ( incidence rate ratio ( IRR ) = 0.60 , 95 % confidence interval ( CI ) = 0.38 - 0.94 , P = .02 ) . Falls were more common in the high-dose group ( 1.47 per person-year vs 0.63 in st and ard-dose group ; IRR = 2.33 , 95 % CI = 1.49 - 3.63 , P Fractures were uncommon and similar in both groups ( high dose 0.10 vs st and ard dose 0.19 per person-year ; P = .31 ) . Mean trough 25-hydroxyvitamin D levels during the trial were 32 . ng/mL in the high-dose group and 25.1 ng/mL in the st and ard-dose group . There was no hypercalcemia or kidney stones in either group . CONCLUSION Monthly high-dose vitamin D3 supplementation reduced the incidence of ARI in older long-term care residents but was associated with a higher rate of falls without an increase in fractures ",
"BACKGROUND To our knowledge , no rigorously design ed clinical trials have evaluated the relation between vitamin D and physician-diagnosed seasonal influenza . OBJECTIVE We investigated the effect of vitamin D supplements on the incidence of seasonal influenza A in schoolchildren . DESIGN From December 2008 through March 2009 , we conducted a r and omized , double-blind , placebo-controlled trial comparing vitamin D(3 ) supplements ( 1200 IU/d ) with placebo in schoolchildren . The primary outcome was the incidence of influenza A , diagnosed with influenza antigen testing with a nasopharyngeal swab specimen . RESULTS Influenza A occurred in 18 of 167 ( 10.8 % ) children in the vitamin D(3 ) group compared with 31 of 167 ( 18.6 % ) children in the placebo group [ relative risk ( RR ) , 0.58 ; 95 % CI : 0.34 , 0.99 ; P = 0.04 ] . The reduction in influenza A was more prominent in children who had not been taking other vitamin D supplements ( RR : 0.36 ; 95 % CI : 0.17 , 0.79 ; P = 0.006 ) and who started nursery school after age 3 y ( RR : 0.36 ; 95 % CI : 0.17 , 0.78 ; P = 0.005 ) . In children with a previous diagnosis of asthma , asthma attacks as a secondary outcome occurred in 2 children receiving vitamin D(3 ) compared with 12 children receiving placebo ( RR : 0.17 ; 95 % CI : 0.04 , 0.73 ; P = 0.006 ) . CONCLUSION This study suggests that vitamin D(3 ) supplementation during the winter may reduce the incidence of influenza A , especially in specific subgroups of schoolchildren . This trial was registered at https://center.umin.ac.jp as UMIN000001373",
"Objectives Since vitamin D insufficiency is common worldwide in people with HIV , we explored safety and efficacy of high dose cholecalciferol ( D₃ ) in Botswana , and evaluated potential modifiers of serum 25 hydroxy vitamin D change ( Δ25D ) . Design Prospect i ve r and omized double-blind 12-week pilot trial of subjects ages 5.0–50.9 years . Methods Sixty subjects r and omized within five age groups to either 4000 or 7000IU per day of D₃ and evaluated for vitamin D , parathyroid hormone , HIV , safety and growth status . Efficacy was defined as serum 25 hydroxy vitamin D ( 25D ) ≥32ng/mL , and safety as no simultaneous elevation of serum calcium and 25D . Also assessed were HIV plasma viral RNA viral load ( VL ) , CD4 % , anti-retroviral therapy ( ART ) regime , and height-adjusted ( HAZ ) , weight-adjusted ( WAZ ) and Body Mass Index ( BMI Z ) Z scores . Results Subjects were 50 % male , age ( mean±SD ) 19.5±11.8 years , CD4 % 31.8±10.4 , with baseline VL log₁₀ range of 1.4 ) in 22 % . From baseline to 12 weeks , 25D increased from 36±9ng/ml to 56±18ng/ml ( p respectively ( p = 0.02 ) . Δ25D was similar by dose . No subjects had simultaneously increased serum calcium and 25D . WAZ and BMI Z improved by 12 weeks ( p increased and VL decreased in the 7000IU/d group ( p Younger ( 5–13y ) and older ( 30–50y ) subjects had greater Δ25D than those 14–29y ( 26±17 and 28±12 vs. 11±11ng/ml , respectively , p≤0.001 ) . Δ25D was higher with efavirenz or nevirapine compared to protease inhibitor based treatment ( 22±12 , 27±17 , vs. 13±10 , respectively , p≤0.03 ) . Conclusions In a pilot study in Botswana , 12-week high dose D₃ supplementation was safe and improved vitamin D , growth and HIV status ; age and ART regimen were significant effect modifiers . Trial Registration Clinical Trials.gov",
"CONTEXT Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures ; however , adherence to daily supplementation is typically poor . OBJECTIVE To determine whether a single annual dose of 500,000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture . DESIGN , SETTING , AND PARTICIPANTS A double-blind , placebo-controlled trial of 2256 community-dwelling women , aged 70 years or older , considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were r and omly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years . The study concluded in 2008 . INTERVENTION 500,000 IU of cholecalciferol or placebo . MAIN OUTCOME MEASURES Falls and fractures were ascertained using monthly calendars ; details were confirmed by telephone interview . Fractures were radiologically confirmed . In a sub study , 137 r and omly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels . RESULTS Women in the cholecalciferol ( vitamin D ) group had 171 fractures vs 135 in the placebo group ; 837 women in the vitamin D group fell 2892 times ( rate , 83.4 per 100 person-years ) while 769 women in the placebo group fell 2512 times ( rate , 72.7 per 100 person-years ; incidence rate ratio [ RR ] , 1.15 ; 95 % confidence interval [ CI ] , 1.02 - 1.30 ; P = .03 ) . The incidence RR for fracture in the vitamin D group was 1.26 ( 95 % CI , 1.00 - 1.59 ; P = .047 ) vs the placebo group ( rates per 100 person-years , 4.9 vitamin D vs 3.9 placebo ) . A temporal pattern was observed in a post hoc analysis of falls . The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months ( test for homogeneity ; P = .02 ) . In the sub study , the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3 % of the sub study participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group , 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L , were approximately 90 nmol/L at 3 months , and remained higher than the placebo group 12 months after dosing . CONCLUSION Among older community-dwelling women , annual oral administration of high-dose cholecalciferol result ed in an increased risk of falls and fractures . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12605000658617 ; is rct n.org Identifier : IS RCT N83409867",
"Background We undertook a 2X2 factorial , r and omized controlled trial ( RCT ) to assess whether vitamin D3 supplementation ( 10,000 international units per week ) versus placebo and gargling versus no gargling could prevent viral , clinical upper respiratory tract infection ( URTI ) in university students . Methods We r and omized 600 students into 4 treatment arms : 1 ) vitamin D3 and gargling , 2 ) placebo and gargling , 3 ) vitamin D3 and no gargling , and 4 ) placebo and no gargling . Students completed weekly electronic surveys and su bmi tted self-collected mid-turbinate nasal flocked swabs during September and October in 2010 or 2011 . Symptomatic students also completed an electronic symptom diary . The primary and secondary outcomes were the occurrence of symptomatic clinical URTI and laboratory confirmed URTI respectively . Results Of 600 participants , 471 ( 78.5 % ) completed all surveys while 43 ( 7.2 % ) completed none ; 150 ( 25.0 % ) reported clinical URTI . Seventy participants ( 23.3 % ) r and omized to vitamin D3 reported clinical URTI compared to 80 ( 26.7 % ) r and omized to placebo ( RR:0.79 , CI95:0.61 - 1.03 , p = 0.09 ) . Eighty-five participants ( 28.3 % ) r and omized to gargling reported clinical URTI compared to 65 participants ( 21.7 % ) r and omized to the no gargling arm ( RR:1.3 , CI95:0.92 - 1.57 , p = 0.19 ) . Laboratory testing identified 70 infections ( 46.7 per 100 URTIs ) . Vitamin D3 treatment was associated with a significantly lower risk for laboratory confirmed URTI ( RR : 0.54 , CI95:0.34 - 0.84 , p = 0.007 ) and with a significantly lower mean viral load measured as log10 viral copies/mL ( mean difference : -0.89 , CI95 : -1.7 , -0.06 , p = 0.04 ) . Fewer students assigned to gargling experienced laboratory confirmed URTI , however this was not statistically significant ( RR:0.82 , CI95:0.53 - 1.26 , p = 0.36 ) . Conclusions These results suggest that vitamin D3 is a promising intervention for the prevention of URTI . Vitamin D3 significantly reduced the risk of laboratory confirmed URTI and may reduce the risk of clinical infections . Trial registration Clinical Trials Registration : NCT01158560",
"Background Declining serum concentrations of 25-hydroxyvitamin D seen in the fall and winter as distance increases from the equator may be a factor in the seasonal increased prevalence of influenza and other viral infections . This study was done to determine if serum 25-hydroxyvitamin D concentrations correlated with the incidence of acute viral respiratory tract infections . Methodology / Findings In this prospect i ve cohort study serial monthly concentrations of 25-hydroxyvitamin D were measured over the fall and winter 2009–2010 in 198 healthy adults , blinded to the nature of the substance being measured . The participants were evaluated for the development of any acute respiratory tract infections by investigators blinded to the 25-hydroxyvitamin D concentrations . The incidence of infection in participants with different concentrations of vitamin D was determined . One hundred ninety-five ( 98.5 % ) of the enrolled participants completed the study . Light skin pigmentation , lean body mass , and supplementation with vitamin D were found to correlate with higher concentrations of 25-hydroxyvitamin D. Concentrations of 38 ng/ml or more were associated with a significant ( p developing acute respiratory tract infections and with a marked reduction in the percentages of days ill . Conclusions / Significance Maintenance of a 25-hydroxyvitamin D serum concentration of 38 ng/ml or higher should significantly reduce the incidence of acute viral respiratory tract infections and the burden of illness caused thereby , at least during the fall and winter in temperate zones . The findings of the present study provide direction for and call for future interventional studies examining the efficacy of vitamin D supplementation in reducing the incidence and severity of specific viral infections , including influenza , in the general population and in sub population s with lower 25-hydroxyvitamin D concentrations , such as pregnant women , dark skinned individuals , and the obese",
"Summary Background Vitamin D has a role in regulating immune function , and its deficiency is a suggested risk factor for childhood pneumonia . Our aim was to assess whether oral supplementation of vitamin D3 ( cholecalciferol ) will reduce the incidence and severity of pneumonia in a high-risk infant population . Methods We did a r and omised placebo-controlled trial to compare oral 100 000 IU ( 2·5 mg ) vitamin D3 with placebo given to children aged 1–11 months in Kabul , Afghanistan . R and omisation was by use of a computer-generated list . Vitamin D or placebo was given by fieldworkers once every 3 months for 18 months . Children presenting at the study hospital with signs of pneumonia had their diagnosis confirmed radiographically . Our primary outcome was the first or only episode of radiologically confirmed pneumonia . Our analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00548379 . Findings 1524 children were assigned to receive vitamin D3 and 1522 placebo . There was no significant difference between the incidence of first or only pneumonia between the vitamin D ( 0·145 per child per year , 95 % CI 0·129–0·164 ) and the placebo group ( 0.137 , 0·121–0·155 ) ; the incidence rate ratio was 1·06 ( 95 % CI 0·89–1·27 ) . From 652 children during five separate periods of testing serum calcifediol , only one child in each of two testing periods had results greater than 375 nmol/L in the intervention group — a toxic level . Interpretations Quarterly bolus doses of oral vitamin D3 supplementation to infants are not an effective intervention to reduce the incidence of pneumonia in infants in this setting . Funding Wellcome Trust and British Council",
"OBJECTIVES To determine whether ( i ) supplementation of oral 100,000 iu of vitamin D(3 ) ( cholecalciferol ) along with antibiotics will reduce the duration of illness in children with pneumonia ; ( ii ) supplementation will reduce the risk of repeat episodes . METHODS Double-blind individually r and omised placebo-controlled trial in an inner-city hospital in Kabul , of 453 children aged 1 - 36 months , diagnosed with non-severe or severe pneumonia at the outpatient clinic . Children with rickets , other concurrent severe diseases , very severe pneumonia or wheeze , were excluded . Children were given vitamin D(3 ) or placebo drops additional to routine pneumonia treatment . RESULTS Two hundred and twenty-four children received vitamin D(3 ; ) and 229 received placebo . There was no significant difference in the mean number of days to recovery between the vitamin D(3 ) ( 4.74 days ; SD 2.22 ) and placebo arms ( 4.98 days ; SD 2.89 ; P = 0.17 ) . The risk of a repeat episode of pneumonia within 90 days of supplementation was lower in the intervention ( 92/204 ; 45 % ) than the placebo group [ 122/211 ; ( 58 % ; relative risk 0.78 ; 95 % CI 0.64 , 0.94 ; P = 0.01 ] . Children in the vitamin D(3 ) group survived longer without experiencing a repeat episode ( 72 days vs. 59 days ; HR 0.71 ; 95 % CI 0.53 - 0.95 ; P = 0.02 ) . CONCLUSION A single high-dose oral vitamin D(3 ) supplementation to young children along with antibiotic treatment for pneumonia could reduce the occurrence of repeat episodes of pneumonia",
"BACKGROUND Recent studies suggest a role for vitamin D in innate immunity , including the prevention of respiratory tract infections ( RTIs ) . We hypothesize that serum 25-hydroxyvitamin D ( 25[OH]D ) levels are inversely associated with self-reported recent upper RTI ( URTI ) . METHODS We performed a secondary analysis of the Third National Health and Nutrition Examination Survey , a probability survey of the US population conducted between 1988 and 1994 . We examined the association between 25(OH)D level and recent URTI in 18 883 participants 12 years and older . The analysis adjusted for demographics and clinical factors ( season , body mass index , smoking history , asthma , and chronic obstructive pulmonary disease ) . RESULTS The median serum 25(OH)D level was 29 ng/mL ( to convert to nanomoles per liter , multiply by 2.496 ) ( interquartile range , 21 - 37 ng/mL ) , and 19 % ( 95 % confidence interval [ CI ] , 18%-20 % ) of participants reported a recent URTI . Recent URTI was reported by 24 % of participants with 25(OH)D levels less than 10 ng/mL , by 20 % with levels of 10 to less than 30 ng/mL , and by 17 % with levels of 30 ng/mL or more ( P 25(OH)D levels were independently associated with recent URTI ( compared with 25[OH]D levels of > or = 30 ng/mL : odds ratio [ OR ] , 1.36 ; 95 % CI , 1.01 - 1.84 for 25(OH)D level and URTI seemed to be stronger in individuals with asthma and chronic obstructive pulmonary disease ( OR , 5.67 and 2.26 , respectively ) . CONCLUSIONS Serum 25(OH)D levels are inversely associated with recent URTI . This association may be stronger in those with respiratory tract diseases . R and omized controlled trials are warranted to explore the effects of vitamin D supplementation on RTI",
"BACKGROUND Patients with chronic obstructive pulmonary disease ( COPD ) often have vitamin D deficiency , which is associated with increased susceptibility to upper respiratory infection-a major precipitant of exacerbation . Multicentre trials of vitamin D supplementation for prevention of exacerbation and upper respiratory infection in patients with COPD are lacking . We therefore investigated whether vitamin D3 ( colecalciferol ) supplementation would reduce the incidence of moderate or severe COPD exacerbations and upper respiratory infections . METHODS We did a r and omised , double-blind , placebo-controlled trial of vitamin D3 supplementation in adults with COPD in 60 general practice s and four Acute National Health Service Trust clinics in London , UK . Patients were allocated to receive six 2-monthly oral doses of 3 mg vitamin D3 or placebo over 1 year in a 1:1 ratio using computer-generated permuted block r and omisation . Participants and study staff were masked to treatment assignment . Co primary outcomes were time to first moderate or severe exacerbation and first upper respiratory infection . Analysis was by intention to treat . A prespecified subgroup analysis was done to assess whether effects of the intervention on the co primary outcomes were modified by baseline vitamin D status . This trial is registered with Clinical Trials.gov , number NCT00977873 . FINDINGS 240 patients were r and omly allocated to the vitamin D3 group ( n=122 ) and placebo group ( n=118 ) . Vitamin D3 compared with placebo did not affect time to first moderate or severe exacerbation ( adjusted hazard ratio 0·86 , 95 % CI 0·60 - 1·24 , p=0·42 ) or time to first upper respiratory infection ( 0·95 , 0·69 - 1·31 , p=0·75 ) . Prespecified subgroup analysis showed that vitamin D3 was protective against moderate or severe exacerbation in participants with baseline serum 25-hydroxyvitamin D concentrations of less than 50 nmol/L ( 0·57 , 0·35 - 0·92 , p=0·021 ) , but not in those with baseline 25-hydroxyvitamin D levels of at least 50 nmol/L ( 1·45 , 0·81 - 2·62 , p=0·21 ; p=0·021 for interaction between allocation and baseline serum 25-hydroxyvitamin D status ) . Baseline vitamin D status did not modify the effect of the intervention on risk of upper respiratory infection ( pinteraction=0·41 ) . INTERPRETATION Vitamin D3 supplementation protected against moderate or severe exacerbation , but not upper respiratory infection , in patients with COPD with baseline 25-hydroxyvitamin D levels of less than 50 nmol/L. Our findings suggest that correction of vitamin D deficiency in patients with COPD reduces the risk of moderate or severe exacerbation . FUNDING UK National Institute for Health Research",
"Rationale Asthma exacerbations are commonly precipitated by viral upper respiratory infections ( URIs ) . Vitamin D insufficiency associates with susceptibility to URI in patients with asthma . Trials of vitamin D in adults with asthma with incidence of exacerbation and URI as primary outcome are lacking . Objective To conduct a r and omised controlled trial of vitamin D3 supplementation for the prevention of asthma exacerbation and URI ( co primary outcomes ) . Measurements and methods 250 adults with asthma in London , UK were allocated to receive six 2-monthly oral doses of 3 mg vitamin D3 ( n=125 ) or placebo ( n=125 ) over 1 year . Secondary outcomes included asthma control test and St George 's Respiratory Question naire scores , fractional exhaled nitric oxide and concentrations of inflammatory markers in induced sputum . Subgroup analyses were performed to determine whether effects of supplementation were modified by baseline vitamin D status or genotype for 34 single nucleotide polymorphisms in 11 vitamin D pathway genes . Main results 206/250 participants ( 82 % ) were vitamin D insufficient at baseline . Vitamin D3 did not influence time to first severe exacerbation ( adjusted HR 1.02 , 95 % CI 0.69 to 1.53 , p=0.91 ) or first URI ( adjusted HR 0.87 , 95 % CI 0.64 to 1.16 , p=0.34 ) . No clinical ly important effect of vitamin D3 was seen on any of the secondary outcomes listed above . The influence of vitamin D3 on co primary outcomes was not modified by baseline vitamin D status or genotype . Conclusions Bolus-dose vitamin D3 supplementation did not influence time to exacerbation or URI in a population of adults with asthma with a high prevalence of baseline vitamin D insufficiency . Trial registration number NCT00978315 ( Clinical Trials.gov )",
"Background : The aim of this study was to evaluate whether a deficit in vitamin D ( VD ) is associated with an increased risk of recurrent acute otitis media ( AOM ) and whether VD supplementation is effective in reducing the number of AOM episodes in otitis-prone children . Methods : A total of 116 children with a history of recurrent AOM ( ≥3 episodes in preceding 6 months or ≥4 episodes in preceding 12 months ) were prospect ively and blindly r and omized to receive oral VD 1000 IU/d or placebo for 4 months . Episodes of AOM were monitored for 6 months . Results : Fifty-eight children received placebo and 58 with similar characteristics were treated with VD . The number of children experiencing ≥1 AOM episode during the study period was significantly lower in the treatment group ( 26 versus 38 ; P = 0.03 ) . There was a marked difference in the number of children who developed uncomplicated AOM ( P children with ≥1 episode of spontaneous otorrhea . The likelihood of AOM was significantly reduced in the patients whose serum VD concentrations were ≥30 ng/mL. Conclusions : VD hypovitaminosis is common in children with recurrent AOM and associated with an increase in the occurrence of AOM when serum 25(OH)D levels are administration of VD in a dosage of 1000 IU/d restores serum values of ≥30 ng/mL in most cases and is associated with a significant reduction in the risk of uncomplicated AOM",
"CONTEXT Observational studies have reported an inverse association between serum 25-hydroxyvitamin D ( 25-OHD ) levels and incidence of upper respiratory tract infections ( URTIs ) . However , results of clinical trials of vitamin D supplementation have been inconclusive . OBJECTIVE To determine the effect of vitamin D supplementation on incidence and severity of URTIs in healthy adults . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial conducted among 322 healthy adults between February 2010 and November 2011 in Christchurch , New Zeal and . INTERVENTION Participants were r and omly assigned to receive an initial dose of 200,000 IU oral vitamin D3 , then 200,000 IU 1 month later , then 100,000 IU monthly ( n = 161 ) , or placebo administered in an identical dosing regimen ( n = 161 ) , for a total of 18 months . MAIN OUTCOME MEASURES The primary end point was number of URTI episodes . Secondary end points were duration of URTI episodes , severity of URTI episodes , and number of days of missed work due to URTI episodes . RESULTS The mean baseline 25-OHD level of participants was 29 ( SD , 9 ) ng/mL. Vitamin D supplementation result ed in an increase in serum 25-OHD levels that was maintained at greater than 48 ng/mL throughout the study . There were 593 URTI episodes in the vitamin D group and 611 in the placebo group , with no statistically significant differences in the number of URTIs per participant ( mean , 3.7 per person in the vitamin D group and 3.8 per person in the placebo group ; risk ratio , 0.97 ; 95 % CI , 0.85 - 1.11 ) , number of days of missed work as a result of URTIs ( mean , 0.76 days in each group ; risk ratio , 1.03 ; 95 % CI , 0.81 - 1.30 ) , duration of symptoms per episode ( mean , 12 days in each group ; risk ratio , 0.96 ; 95 % CI , 0.73 - 1.25 ) , or severity of URTI episodes . These findings remained unchanged when the analysis was repeated by season and by baseline 25-OHD levels . CONCLUSION In this trial , monthly administration of 100,000 IU of vitamin D did not reduce the incidence or severity of URTIs in healthy adults . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN12609000486224",
"CONTEXT AND OBJECTIVE Suboptimal vitamin D status can be corrected by vitamin D supplementation , but individual responses to supplementation vary . We aim ed to examine genetic and nongenetic determinants of change in serum 25-hydroxyvitamin D ( 25(OH)D ) after supplementation . DESIGN AND PARTICIPANTS We used data from a pilot r and omized controlled trial in which 644 adults aged 60 to 84 years were r and omly assigned to monthly doses of placebo , 30 000 IU , or 60 000 IU vitamin D3 for 12 months . Baseline characteristics were obtained from a self-administered question naire . Eighty-eight single-nucleotide polymorphisms ( SNPs ) in 41 c and i date genes were genotyped using Sequenom MassArray technology . Serum 25(OH)D levels before and after the intervention were measured using the Diasorin Liaison platform immunoassay . We used linear regression models to examine associations between genetic and nongenetic factors and change in serum 25(OH)D levels . RESULTS Supplement dose and baseline 25(OH)D level explained 24 % of the variability in response to supplementation . Body mass index , self-reported health status , and ambient UV radiation made a small additional contribution . SNPs in CYP2R1 , IRF4 , MC1R , CYP27B1 , VDR , TYRP1 , MCM6 , and HERC2 were associated with change in 25(OH)D level , although only CYP2R1 was significant after adjustment for multiple testing . Models including SNPs explained a similar proportion of variability in response to supplementation as models that included personal and environmental factors . CONCLUSION Stepwise regression analyses suggest that genetic variability may be associated with response to supplementation , perhaps suggesting that some people might need higher doses to reach optimal 25(OH)D levels or that there is variability in the physiologically normal level of",
"BACKGROUND Observational data suggested that supplementation with vitamin D could reduce risk of infection , but trial data are inconsistent . OBJECTIVE We aim ed to examine the effect of oral vitamin D supplementation on antibiotic use . DESIGN We conducted a post hoc analysis of data from pilot D-Health , which is a r and omized trial carried out in a general community setting between October 2010 and February 2012 . A total of 644 Australian residents aged 60 - 84 y were r and omly assigned to receive monthly doses of a placebo ( n = 214 ) or 30,000 ( n = 215 ) or 60,000 ( n = 215 ) IU oral cholecalciferol for ≤12 mo . Antibiotics prescribed during the intervention period were ascertained by linkage with pharmacy records through the national health insurance scheme ( Medicare Australia ) . RESULTS People who were r and omly assigned 60,000 IU cholecalciferol had nonsignificant 28 % lower risk of having antibiotics prescribed at least once than did people in the placebo group ( RR : 0.72 ; 95 % CI : 0.48 , 1.07 ) . In analyses stratified by age , in subjects aged ≥70 y , there was a significant reduction in antibiotic use in the high-dose vitamin D compared with placebo groups ( RR : 0.53 ; 95 % CI : 0.32 , 0.90 ) , whereas there was no effect in participants aged lower risk of infection , particularly in older adults . The trial was registered at the Australian New Zeal and Clinical Trials Registry ( anzctr.org.au ) as ACTRN12609001063202",
"In a prior r and omized trial , we found that the incidence of influenza A was less in the vitamin D3 group than among those on placebo , but the total incidence of either influenza A or B did not differ between groups . In this trial , the incidence of influenza A or B was less in the vitamin D3 group than in the placebo group only during the first half of the study . To eluci date whether vitamin D3 has preventive actions against influenza A , we conducted another trial during the 2009 p and emic of the H1N1 subtype of influenza A. Students ( n = 247 ) of a Japanese high school were r and omly assigned to receive vitamin D3 supplements ( n = 148 ; 2000 IU per day ) or a placebo ( n = 99 ) in a double-blind study for 2 months . The primary outcome was incidence of influenza A diagnosed by a rapid influenza diagnostic test by medical doctors . Influenza A was equally likely in the vitamin D3 group ( 20/148 : 13.5 % ) compared with the placebo group ( 12/99 : 12.1 % ) . By post hoc analysis , influenza A occurred significantly less in the vitamin D3 group ( 2/148 : 1.4 % ) compared with the placebo group ( 8/99 : 8.1 % ) ( risk ratio , 0.17 ; 95 % confidence interval , 0.04 to 0.77 ; P = 0.009 ) in the first month . However , during the second month , the vitamin D3 group experienced more events and effectively caught up with the placebo group . Vitamin D3 supplementation did not lower the overall incidence of influenza A during the 2009 H1N1 p and emic . A post hoc analysis suggests that the initial benefit during the first month of treatment was lost during the second month",
"Vitamin D has been shown to be an important immune system regulator . Vitamin D insufficiency during winter may cause increased susceptibility to upper respiratory tract infections ( URIs ) . To determine whether vitamin D supplementation during the winter season prevents or decreases URI symptoms , 162 adults were r and omized to receive 50 microg vitamin D3 ( 2000 IU ) daily or matching placebo for 12 weeks . A bi-weekly question naire was used to record the incidence and severity of URI symptoms . There was no difference in the incidence of URIs between the vitamin D and placebo groups ( 48 URIs vs. 50 URIs , respectively , P=0.57 ) . There was no difference in the duration or severity of URI symptoms between the vitamin D and placebo groups [ 5.4+/-4.8 days vs. 5.3+/-3.1 days , respectively , P=0.86 ( 95 % CI for the difference in duration -1.8 to 2.1 ) ] . The mean 25-hydroxyvitamin D level at baseline was similar in both groups ( 64.3+/-25.4 nmol/l in the vitamin D group ; 63.0+/-25.8 nmol/l in the placebo group ; n.s . ) . After 12 weeks , 25-hydroxyvitamin D levels increased significantly to 88.5+/-23.2 nmol/l in the vitamin D group , whereas there was no change in vitamin D levels in the placebo group . There was no benefit of vitamin D3 supplementation in decreasing the incidence or severity of symptomatic URIs during winter . Further studies are needed to determine the role of vitamin D in infection",
"Observational studies identified associations between vitamin D insufficiency ( serum 25(OH)D risk of upper respiratory infection ( URI ) . Swimmers are highly prone to URIs , which might hinder their performance . The aim of this study was to examine if vitamin D3 supplementation reduces URI burden in vitamin D-insufficient swimmers . Fifty-five competitive adolescent swimmers with vitamin D insufficiency were r and omized to receive vitamin D3 ( 2,000IU·d-1 ) or placebo for 12 winter weeks . A URI symptom question naire was completed weekly . Serum 25(OH)D concentrations were measured by radio-immunoassay before and after supplementation . We used linear regression to examine the relation between the change in 25(OH)D concentrations during the trial , and the duration and severity of URIs . There were no between-group differences in the frequency , severity , or duration of URIs . Exploratory analyses revealed that in the placebo group only , the change in 25(OH)D concentrations during the trial was highly associated with the duration of URIs ( r = -0.90,p the severity of URIs ( r = -0.65,p = .043 ) . The between-group differences for duration were highly significant . Vitamin D3 supplementation in adolescent swimmers with vitamin D insufficiency did not reduce URI burden . However , larger decreases in serum 25(OH)D concentrations were associated with significantly longer and more severe URI episodes",
"In our prior r and omized trial on preventing influenza , asthma attacks as a secondary outcome occurred less often in the vitamin D group than in the placebo group . We aim ed to clarify whether low‐dose , short‐term vitamin D supplementation , in addition to st and ard treatments , improves control of childhood asthma",
"BACKGROUND R and omized controlled trials testing the association between vitamin D status and upper respiratory tract infection ( URTI ) have given mixed results . During a multicenter , r and omized controlled trial of colorectal adenoma chemoprevention , we tested whether 1000 IU/day vitamin D(3 ) supplementation reduced winter episodes and duration of URTI and its composite syndromes , influenza-like illness ( ILI ; fever and ≥2 of sore throat , cough , muscle ache , or headache ) and colds ( no fever , and ≥2 of runny nose , nasal congestion , sneezing , sore throat , cough , swollen or tender neck gl and s ) . METHODS The 2259 trial participants were aged 45 - 75 , in good health , had a history of colorectal adenoma , and had a serum 25-hydroxyvitamin D level ≥12 ng/mL. They were r and omized to vitamin D(3 ) ( 1000 IU/day ) , calcium ( 1200 mg/day ) , both , or placebo . Of these , 759 participants completed daily symptom diaries . Secondary data included semiannual surveys of all participants . RESULTS Among those who completed symptom diaries , supplementation did not significantly reduce winter episodes of URTI ( rate ratio [ RR ] , 0.93 ; 95 % confidence interval [ CI ] , .79 - 1.09 ) including colds ( RR , 0.93 ; 95 % CI , .78 - 1.10 ) or ILI ( RR , 0.95 ; 95 % CI , .62 - 1.46 ) , nor did it reduce winter days of illness ( RR , 1.13 ; 95 % CI , .90 - 1.43 ) . There was no significant benefit according to adherence , influenza vaccination , body mass index , or baseline vitamin D status . Semiannual surveys of all participants ( N = 2228 ) identified no benefit of supplementation on ILI ( odds ratio [ OR ] , 1.14 ; 95 % CI , .84 - 1.54 ) or colds ( OR , 1.03 ; 95 % CI , .87 - 1.23 ) . CONCLUSIONS Supplementation with 1000 IU/day vitamin D(3 ) did not significantly reduce the incidence or duration of URTI in adults with a baseline serum 25-hydroxyvitamin D level ≥12"
] | 41163fee-06ff-11f0-808a-c43d1ab1c353 |
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