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OBJECTIVE This article aims to provide the first systematic review of enhanced recovery after surgery ( ERAS ) programs for esophagectomy and generate guidelines . BACKGROUND ERAS programs use multimodal approaches to reduce complications and accelerate recovery . Although ERAS is well established in colorectal surgery , experience after esophagectomy has been minimal . However , esophagectomy remains an extremely high-risk operation , commonly performed in patients with significant comorbidities . Consequently , ERAS may have a significant role to play in improving outcomes . No guidelines or review s have been published in esophagectomy . METHODS We undertook a systematic review of the PubMed , EMBASE , and the Cochrane data bases in July 2012 . The literature was search ed for descriptions of ERAS in esophagectomy . Components of successful ERAS programs were determined , and when not directly available for esophagectomy , extrapolation from related evidence was made . Grade d recommendations for each component were then generated . RESULTS Six retrospective studies have assessed ERAS for esophagectomy , demonstrating favorable morbidity , mortality , and length of stay . Method ological quality is , however , low . Overall , there is little direct evidence for components of ERAS , with much derived from nonesophageal thoracoabdominal surgery . CONCLUSIONS ERAS in principle seems logical and safe for esophagectomy . However , the underlying evidence is poor and lacking . Despite this , a number of recommendations for practice and research can be made
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"CONTEXT Postoperative enteral nutrition is thought to reduce complications and speed recovery after pancreatic resection . There is little evidence on the best route for delivery of enteral nutrition . Currently we use percutaneous transperitoneal jejunostomy or percutaneous transperitoneal gastrojejunostomy , or the nasojejunal route to deliver enteral nutrition , according to surgeon preference . OBJECTIVE To compare morbidity , efficiency , and safety of these three routes for enteral nutrition following pancreaticoduodenectomy . PATIENTS Data were obtained from a prospect ively maintained data base , for all patients undergoing pancreatic resection between January 2007 and June 2008 . One-hundred pancreatic resected patients underwent enteral nutrition : 93 had Whipple 's operations and 7 had total pancreatectomies . INTERVENTION Enteral nutrition was delivered by agreed protocol , starting within 24 h of operation and increasing over 2 - 3 days to meet full nutritional requirement . RESULTS Delivery route of enteral nutrition was : percutaneous transperitoneal jejunostomy in 25 ( 25 % ) , percutaneous transperitoneal gastrojejunostomy in 32 ( 32 % ) and nasojejunal in 43 ( 43 % ) . The incidence of catheter-related complications was higher in percutaneous techniques : 24 % in percutaneous transperitoneal jejunostomy and 34 % in percutaneous transperitoneal gastrojejunostomy as compared to nasojejunal technique ( 12 % ) . Median time to complete establishment of oral intake was 14 , 14 and 10 days in percutaneous transperitoneal jejunostomy , percutaneous transperitoneal gastrojejunostomy , and nasojejunal groups , respectively . Nasojejunal tubes were removed at median 11 days ( mean 11.5 days ) compared to 5 - 6 weeks for percutaneous transperitoneal jejunostomy and percutaneous transperitoneal gastrojejunostomy . Commonest catheter-related complication in the percutaneous transperitoneal jejunostomy and percutaneous transperitoneal gastrojejunostomy was blockage ( n=6 ; 10.5 % ) , followed by pain after removal of feeding tube at 5 - 6 weeks ( n=5 ; 8.8 % ) , whereas in the nasojejunal group it was blockage ( n=3 ; 7.0 % ) , followed by displacement ( n=2 ; 4.7 % ) . Two patients died postoperatively in this cohort , however , there were no catheter-related mortalities . CONCLUSION Enteral nutrition following pancreatic resection can be delivered in different ways . Nasojejunal feeding was associated with fewest and less serious complications . On current evidence surgeon preference is a reasonable way to decide enteral nutrition but a r and omized controlled trial is needed to address this issue",
"Introduction Several studies have shown that goal -directed hemodynamic and fluid optimization may result in improved outcome . However , the methods used were either invasive or had other limitations . The aim of this study was to perform intraoperative goal -directed therapy with a minimally invasive , easy to use device ( FloTrac/Vigileo ) , and to evaluate possible improvements in patient outcome determined by the duration of hospital stay and the incidence of complications compared to a st and ard management protocol . Methods In this r and omized , controlled trial 60 high-risk patients scheduled for major abdominal surgery were included . Patients were allocated into either an enhanced hemodynamic monitoring group using a cardiac index based intraoperative optimization protocol ( FloTrac/Vigileo device , GDT-group , n = 30 ) or a st and ard management group ( Control-group , n = 30 ) , based on st and ard monitoring data . Results The median duration of hospital stay was significantly reduced in the GDT-group with 15 ( 12 - 17.75 ) days versus 19 ( 14 - 23.5 ) days ( P = 0.006 ) and fewer patients developed complications than in the Control-group [ 6 patients ( 20 % ) versus 15 patients ( 50 % ) , P = 0.03 ] . The total number of complications was reduced in the GDT-group ( 17 versus 49 complications , P = 0.001 ) . Conclusions In high-risk patients undergoing major abdominal surgery , implementation of an intraoperative goal -directed hemodynamic optimization protocol using the FloTrac/Vigileo device was associated with a reduced length of hospital stay and a lower incidence of complications compared to a st and ard management protocol .Trial Registration Clinical trial registration information : Unique identifier :",
"CONTEXT Postoperative pulmonary complications ( PPCs ) after coronary artery bypass graft ( CABG ) surgery are a major source of morbidity and mortality , and increase length of hospital stay and re source utilization . The prehospitalization period before CABG surgery may be used to improve a patient 's pulmonary condition . The efficacy of preoperative inspiratory muscle training ( IMT ) in reducing the incidence of PPCs in high-risk patients undergoing CABG surgery has not yet been determined . OBJECTIVE To evaluate the prophylactic efficacy of preoperative IMT on the incidence of PPCs in high-risk patients scheduled for elective CABG surgery . DESIGN , SETTING , AND PATIENTS A single-blind , r and omized clinical trial conducted at the University Medical Center Utrecht , Utrecht , the Netherl and s , with enrollment between July 2002 and August 2005 . Of 655 patients referred for elective CABG surgery , 299 ( 45.6 % ) met criteria for high risk of developing PPCs , of whom 279 were enrolled and followed up until discharge from hospital . INTERVENTION Patients were r and omly assigned to receive either preoperative IMT ( n = 140 ) or usual care ( n = 139 ) . Both groups received the same postoperative physical therapy . MAIN OUTCOME MEASURES Incidence of PPCs , especially pneumonia , and duration of postoperative hospitalization . RESULTS Both groups were comparable at baseline . After CABG surgery , PPCs were present in 25 ( 18.0 % ) of 139 patients in the IMT group and 48 ( 35.0 % ) of 137 patients in the usual care group ( odds ratio [ OR ] , 0.52 ; 95 % confidence interval [ 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 ) . Median duration of postoperative hospitalization was 7 days ( range , 5 - 41 days ) in the IMT group vs 8 days ( range , 6 - 70 days ) in the usual care group by Mann-Whitney U statistic ( z = -2.42 ; P = .02 ) . CONCLUSION Preoperative IMT reduced the incidence of PPCs and duration of postoperative hospitalization in patients at high risk of developing a pulmonary complication undergoing CABG surgery . TRIAL REGISTRATION is rct n.org Identifier : IS RCT N17691887",
"Background : The aim of this study was to compare the efficacy , safety and achievement of the target hemoglobin level ( Hb ≥10 g/dl ) in patients with preoperative anemia due to menorrhagia who received intravenous iron sucrose compared with oral iron protein succinylate for anemia management . Methods : Seventy-six patients with Hb levels to receive either intravenous iron sucrose ( based on the calculated total iron deficit divided into 2 ampoule infusions intravenously 3 times a week , beginning 3 weeks before surgery ) or oral iron ( 80 mg/day of oral iron protein succinylate daily ) . Results : The intravenous iron group had higher increases in Hb ( 3.0 vs. 0.8 g/dl ; p ) and ferritin levels ( 170.1 vs. 4.1 μg/l ; p Achieving the target Hb was also higher in the intravenous iron group than in the oral iron group ( 76.7 vs. 11.5 % ; p There were tolerable adverse events in both groups . Conclusion : Preoperative intravenous iron sucrose administration is more effective than oral iron and is as safe as oral iron therapy in the correction of preoperative anemia due to menorrhagia",
"OBJECTIVE To compare surgical results and complications in the immediate postoperative course between the use of a single drain and two-drain post-anatomical pulmonary resections . PATIENTS AND METHODS Between January 2004 and September 2005 , 143 patients were scheduled for pulmonary lobectomy or bilobectomy for non-small cell lung cancer ( NSCLC ) in our department . Pneumonectomies , wedge resection , and nonresectable thoracotomies were excluded from the study . Hundred and nineteen patients were enrolled in this study . Clinical and surgical variables were collected prospect ively . Lobectomy or bilobectomy and systematic mediastinal node dissection were performed in all cases . The patients were r and omly assigned to receive single ( group A ) or two ( group B ) drains , independent of any preoperative or intraoperative variables . Group A consisted of 60 patients who had one single drain sited in the mid-position and group B consisted of 59 patients who had two classical drains ( apical and basal ) . There were no surgical , oncological , or physiological differences between the groups ( p = NS ) . RESULTS There were no statistically significant differences detected between the groups in relation to postsurgical morbidity or mortality and other issues studied , except in analgesia requirements ( group A less than group B , p subcutaneous emphysema , new drains needed , residual pleural effusion , or residual space ( p>0.05 ) . CONCLUSIONS In our study , we did not find significant differences between the use of one or two drains after lobectomy or bilobectomy in relation to early postoperative outcome . However , the use of only one drain is more economical and is less painful for patients , without any additional adverse consequences",
"Purpose Stoma formation is a well-known cause for delayed discharge following colorectal surgery . This has been addressed by the enhanced recovery programme ( ERP ) preoperatively through stoma counselling sessions . These aim to promote independent stoma management post-operatively , thus expediting hospital discharge . We compared the numbers of patients with prolonged hospital stay secondary to delayed independent stoma management prior to and following the introduction of an enhanced recovery programme with preoperative stoma education . Methods Data collection on patients undergoing anterior resection with the formation of a loop ileostomy was carried out retrospectively prior to ERP ( January 2006 to August 2008 ) and prospect ively following the introduction of ERP ( September 2008 to October 2010 ) . Comparisons were made in patients with prolonged hospital stay ( defined as hospital stay of more than 5 days ) secondary to stoma management . Results Two hundred forty patients underwent elective anterior resection with the formation of a loop ileostomy , 120 prior ERP and 120 post-ERP . Average length of hospital stay was 14 days before ERP introduction , with a range of 7–25 days . The mean length of stay amongst the ERP patients was 8 days ( p = 0.17 ) , ranging from 3 to 17 days . Twenty-one patients in the pre-ERP group ( 17.5 % ) experienced postponed hospital discharge due to a delay in independent stoma management , compared to one patient experiencing such a delay after the introduction of ERP ( 0.8 % , p Delayed discharge secondary to independent stoma management can be significantly reduced with preoperative stoma management teaching as part of an enhanced recovery programme",
"Background : The oesophagectomy procedure includes the formation of a gastric tube to re‐establish the continuity of the gastrointestinal tract . The effect of thoracic epidural analgesia ( TEA ) on gastric mucosal blood flow ( GMBF ) remains unknown in clinical practice . The aim of this prospect i ve observational study was to assess the microcirculatory changes induced by TEA in the early post‐operative course",
"BACKGROUND Enteral nutrition ( EN ) is now used more frequently than total parenteral nutrition ( TPN ) for nutritional support after resection for esophageal cancer . But consensus regarding which type of nutrition should be used does not exist . We studied the effect of TPN and EN on patients ' nutritional status and immune function in the immediate postoperative period after esophageal cancer resection . METHODS We enrolled 30 patients ( 27 men and 3 women ) who underwent subtotal esophagectomy . The patients were r and omly assigned to TPN or EN group . Either TPN or EN was begun on postoperative day 1 . On postoperative days 1 , 3 , and 7 , three endpoints were measured : albumin , C-reactive protein , and Th1/Th2 balance . RESULTS All patients completed the study . Anastomotic leaks occurred in 6 patients in the TPN group and 7 patients in the EN group . Albumin , Th1/Th2 balance , and C-reactive protein did not differ between the groups . Th1/Th2 balance was not different regardless of the preoperative treatment or complications . CONCLUSIONS No differences in immune function , nutritional state , or inflammatory response were seen between patients supported with TPN and those supported with EN . The results of our study suggest that perioperative nutritional support can be safely performed either with TPN or EN",
"BACKGROUND Although current opinion favours the use of enteral over parenteral nutrition , the clinical benefits of early postoperative nutrition in patients undergoing elective surgery have never been clearly shown . We aim ed to test the hypothesis that postoperative enteral nutrition is better ( fewer postoperative complications ) than parenteral nutrition containing similar energy and nitrogen amounts ( 112 kJ kg(-1 ) day(-1 ) and 1.4 g aminoacid kg(-1 ) day(-1 ) ) . METHODS We did a r and omised multicentre clinical trial in patients with gastrointestinal cancer who were malnourished and c and i date s for major elective surgery . 159 patients were assigned to enteral nutrition and 158 to parenteral nutrition . The primary endpoint was the occurrence of postoperative complications , and secondary endpoints were length of postoperative hospital stay , adverse effects , and treatment crossover . Analysis was by intention to treat . FINDINGS Postoperative complications occurred in 54 ( 34 % ) patients fed enterally versus 78 ( 49 % ) fed parenterally ( relative risk 0.69 , 95 % CI 0.53 - 0.90 , p=0.005 ) . Length of postoperative stay was 13.4 days and 15.0 days in the enteral nutrition and parenteral nutrition groups , respectively ( p=0.009 ) . Adverse effects occurred in 56 ( 35 % ) patients fed enterally versus 22 ( 14 % ) patients fed parenterally ( 2.50 , 1.61 - 3.86 , p 14 ( 9 % ) patients on enteral nutrition had to switch to parenteral nutrition , whereas none of those fed parenterally crossed over to enteral feeding . INTERPRETATION We conclude that early enteral nutrition significantly reduces the complication rate and duration of postoperative stay compared with parenteral nutrition , although parenteral nutrition is better tolerated than enteral nutrition",
"Background Esophageal resection ( ER ) remains the st and ard therapy for early esophageal cancer ; however , because of concerns regarding high levels of morbidity and mortality reported in analyses of national data bases , many patients are relegated to less effective endoscopic or chemotherapeutic approaches . Methods All patients undergoing esophagectomy by a single surgeon for cancer or high- grade dysplasia between 05/91–05/06 were prospect ively entered into an IRB-approved data base . All aspects of work-up and treatment were guided by an evolving st and ardized perioperative clinical pathway . Results Three hundred forty consecutive patients , mean age of 64 ( 33–90 ) , underwent ER for Barrett ’s esophagus ( 17 ) or invasive cancer stages I-87 , II-133 , III-94 , IV-9 . One hundred thirty-nine ( 41 % ) had neoadjuvant therapy . Sixty-three percent were American Society of Anesthesiologists class III or IV , and five different operative approaches were used . Patient were managed intraoperatively with a “ fluid restriction ” protocol . Mean intraoperative blood loss was 230 cc . 99.5 % of patients were extubated immediately , and mean ICU and hospital stays were 2.25 ( 1–30 ) and 11.5 ( 6–49 ) days , respectively . Postoperative analgesia was managed with patient-controlled epidural analgesia in 98.5 % , and 86 % were mobilized on day 1 after surgery . Complications occurred in 153 patients ( 45 % ) , most commonly atrial dysrhythmia ( 13 % ) , and postoperative delirium ( 11 % ) . Anastomotic leaks occurred in 13 patients ( 3.8 % ) . Mortality occurred in one patient ( 0.3 % ) . No significant differences were seen in length of stay , operative time , blood loss , or complications in patients receiving neoadjuvant therapy . For stages I , II , and III , patients between 1998–2004 Kaplan – Meier 5-year cumulative survival was 92.4 , 57.1 , and 34.5 % , respectively . Conclusions Surgical treatment of esophageal cancer can be done with moderate morbidity and very low mortality , and the expectation of improved levels of survival , especially in early-stage patients . St and ardized perioperative clinical pathways can provide the infrastructure for the treatment of these patients and should include increased efforts to minimize blood loss and transfusions , improve postoperative pain control and extubation rates , and facilitate early mobilization and discharge . ER , as sole therapy or in combination with radiation/chemotherapy , should remain the st and ard of care in patients with early and locoregional esophageal cancer",
"Introduction Several studies have shown that maximizing stroke volume ( or increasing it until a plateau is reached ) by volume loading during high-risk surgery may improve post-operative outcome . This goal could be achieved simply by minimizing the variation in arterial pulse pressure ( ΔPP ) induced by mechanical ventilation . We tested this hypothesis in a prospect i ve , r and omized , single-centre study . The primary endpoint was the length of postoperative stay in hospital . Methods Thirty-three patients undergoing high-risk surgery were r and omized either to a control group ( group C , n = 16 ) or to an intervention group ( group I , n = 17 ) . In group I , ΔPP was continuously monitored during surgery by a multiparameter bedside monitor and minimized to 10 % or less by volume loading . Results Both groups were comparable in terms of demographic data , American Society of Anesthesiology score , type , and duration of surgery . During surgery , group I received more fluid than group C ( 4,618 ± 1,557 versus 1,694 ± 705 ml ( mean ± SD ) , P and ΔPP decreased from 22 ± 75 to 9 ± 1 % ( P The median duration of postoperative stay in hospital ( 7 versus 17 days , P The number of postoperative complications per patient ( 1.4 ± 2.1 versus 3.9 ± 2.8 , P the median duration of mechanical ventilation ( 1 versus 5 days , P and stay in the intensive care unit ( 3 versus 9 days , P improves postoperative outcome and decreases the length of stay in hospital . Trial registration",
"BACKGROUND Operative procedures on the pleural space are usually managed by chest tube drainage . Timing for removing the tube is empirically established , with wide variation among surgeons . Our objective was to evaluate the effectiveness and safety of establishing a volume of 200 mL/d of uninfected drainage as a threshold for removal of chest tube , as compared with more frequently used volumes of 100 and 150 mL/d . STUDY DESIGN A prospect i ve r and omized study was performed in a single institution . Patients ( n = 139 ) su bmi tting to pleural drainage after surgical procedures were r and omized to one of three groups , defined by the planned timing of chest tube removal ( depending on the threshold volume per day of pleural fluid drained ) : G-100 ( 91 consecutive patients had chest tubes removed when drainage was less than 200 mL/d ( G-val , prospect i ve validation group ) . All patients had similar discharge and 60-day followup . Drainage time , hospital stay , and reaccumulation rate were registered . RESULTS Drainage time ( median days : 3.5 for G-100 , 3 for G-150 , 3 for G-200 , 3 for G-val ) and hospital stay ( median days : 4 for G-100 , 3 for G-150 , 3 for G-200 , 3 for G-val ) were not statistically different among groups . Radiologic reaccumulation rates were 9.1 % for G-100 , 13.1 % for G-150 , 5.4 % for G-200 , and 10.9 % for G-val , and the thoracenteses rates were 2.3 % , 0.8 % , 2.7 % , and 3.3 % , respectively , with no major differences among groups ( G-100 versus G-150 versus G-200 ; G-200 versus G-val ) . CONCLUSIONS Increasing the threshold of daily drainage to 200 mL before removing the chest tube did not markedly affect drainage , hospitalization time , or overall costs , nor did it increase the likelihood of major pleural fluid reaccumulation . This volume ( 200 mL/d ) could be recommended for chest tube withdrawal decision for uninfected pleural fluid with no evidence of air leaks",
"Introduction Surgeons routinely use nasogastric ( NG ) tubes in most esophageal resection surgeries . Considering the numerous complications caused by using the tube and the uncertainty about its usefulness and the scarcity of studies conducted on the subject , particularly in patients with esophageal cancer , the necessity of using the tube in these types of cases is investigated in the present study . Methods In this clinical trial , patients with esophageal cancer were r and omized into groups with NG tube and without NG tube after surgery ; the latter were prescribed Metoclopramide , as well . The variables recorded for each patient included the first day of gas passage , defecation and bowel sounds ( BSs ) auscultation , as well as the duration of postoperative hospitalization , nausea and vomiting , abdominal distension , pulmonary complications , wound complications , anastomosis leak , and the need for placing/replacing the NG tube . Results The incidence of anastomosis leak was significantly higher in the NG-tube group ( 6 vs. 0 ; P = 0.016 ) . Other complications were not different in the two groups . The mean time of gas passage , defecation , BS auscultation , and the duration of postoperative hospitalization did not have meaningful differences in the two groups . The need for placing/replacing the NG tube was the same for both groups . Conclusions The routine application of NG tubes after surgery is not recommended for all patients . We suggest that NG tubes should be used according to the specific problems of each patient",
"BACKGROUND Perioperative epidural analgesia provides continuous pain control and may have advantages over parenteral opiate administration . This study assessed the impact of epidural analgesia on quality of life ( QOL ) of patients undergoing major surgery . METHODS Sixty patients undergoing thoracic or thoraco-abdominal surgery were studied prospect ively . Patients were r and omly assigned to receive either thoracic epidural analgesia or patient-controlled i.v . opiate analgesia ( PCA ) after operation . Visual analogue pain and sedation scores were recorded for the period of the study . QOL health surveys at 24 h ( SF-8 acute form ) and at 1 week ( SF-36 ) were recorded . Results were examined by uni- and multivariate analyses corrected for the effect of multiple comparisons . RESULTS Mean pain scores were significantly lower in the epidural group at most time points . Physical and mental scores in the epidural group were significantly better than the PCA group for both SF-8 and SF-36 QOL health surveys ( P QOL and delivers better analgesia compared with PCA in patients undergoing major thoraco-abdominal surgery",
"BACKGROUND Patients undergoing oesophageal surgery have a high risk for post-operative complications including pulmonary infections . Recently , physical therapy has shifted from the post-operative to the pre-operative phase to diminish post-operative complications and to shorten hospital stay . The purpose of this pilot study was to investigate the feasibility and initial effectiveness of pre-operative inspiratory muscle training ( IMT ) on the incidence of pneumonia in patients undergoing oesophagectomy . METHODS A pragmatic non-r and omized controlled trial was conducted among all patients who underwent an oesophagectomy between January 2009 and February 2010 . Patients in the intervention group received IMT prior to surgery . Feasibility was assessed on the basis of the occurrence of adverse effects during testing or training and patient satisfaction . Initial effectiveness on respiratory function was evaluated by maximal inspiratory pressure ( MIP ) and endurance , the incidence of post-operative pneumonia and length of hospital stay . RESULTS Eighty-three patients were included , of which 44 received pre-operative IMT . No adverse effects were observed . IMT was well tolerated and appreciated . In the intervention group , the median MIP and endurance improved significantly after IMT by 32 % and 41 % , respectively ( p incidence of post-operative pneumonia and the length of hospital stay were comparable for the intervention and the conventional care groups ( pneumonia , 25 % vs. 23 % [ p = 0.84 ] ; hospitalization , 13.5 vs. 12 days [ p = 0.08 ] ) . CONCLUSIONS Pre-operative IMT is feasible in patients with oesophageal carcinoma and significantly improves respiratory muscle function . This , however , did not result in a reduction of post-operative pneumonia in patients undergoing oesophagectomy",
"Background : Post‐operative insulin resistance and hyperglycaemia are associated with an impaired outcome after surgery . Pre‐operative oral carbohydrate loading ( CHO ) reduces post‐operative insulin resistance with a reduced risk of hyperglycaemia during post‐operative nutrition . Insulin‐resistant diabetic patients have not been given CHO because the effects on pre‐operative glycaemia and gastric emptying are unknown",
"Abstract : Background : Despite importance of chest tube insertion in chest trauma , there is no general agreement on the level of daily volume drainage from chest tube . This study was conducted to compare the effectiveness and safety of chest tube removal at the levels of 150 ml/day and 200 ml/day . Methods : Eligible patients ( 138 ) who needed replacement of chest tube ( because of trauma or malignancy ) were r and omized into two groups ; control ( removal of chest tube when drainage reached to 150 ml/day ) and trial ( removal of chest tube at the level of 200 ml/day ) . All patients received st and ard care during hospital admission and a follow-up visit after 7days of discharge from hospital . Patients were then compared in terms of major clinical outcomes using chisquared and t-test . Results : From the total of 138 patients , 70 and 68 patients were r and omized to control ( G150 ) and trial ( G200 ) group , respectively . Baseline characteristics were comparable between the two groups . Although the trial group had a shorter mean for length of hospital stay ( LOS ) ( 4.1 compared to 4.8 , p=0.04 ) , their differences in drainage time did not reach to the level of statistical significance ( p=0.1 ) . Analysis of data showed no statistically significant differences between the rate of radiological reaccumulation , thoracentesis and decrease in pulmonary sounds ( auscultatory ) , one week after discharge from hospital . Conclusions : Compared to a daily volume drainage of 150 ml , removal of chest tube when there is 200 ml/day is safe and will even result in a shorter hospital stay . This in turn leads to a lower cost",
"OBJECTIVE The aim of this study was to assess the immediate influence of chest tube removal on chest pain and forced expiratory volume in 1 s ( FEV1 ) after pulmonary resection . METHODS Prospect i ve longitudinal investigation on 104 consecutive patients ( 53 wedge/segmentectomies and 51 lobectomies ; 69 muscle and nerve-sparing lateral thoracotomy and 35 video-assisted thoracoscopic surgery ( VATS ) ) . Post-operative chest pain was controlled in all patients by a st and ardized combination of oral and intravenous non-opioid analgesics . All patients had one chest tube ( 24 French ) . Static and dynamic ( after forced expiratory effort ) pain and FEV1 were assessed before and 1 h after the chest tube removal by the same operator . No additional analgesics were administered before or after the chest tube removal . The pain level was assessed by the numeric pain scale [ range : 0 ( no pain)-10 ( excruciating pain ) ] . FEV1 was assessed by a portable spirometer . Bronchodilators were not used in these patients . Pre- and post-removal measurements were compared by the Wilcoxon signed rank test . RESULTS The average pre-removal static and dynamic pain scores were 2.6 and 4.1 , respectively . The static and dynamic pain scores decreased by 42 and 41 % , respectively , after the tube removal ( P average FEV1 before the chest tube removal was 1.5 l or 53 % of the predicted value and increased by 13 % after the tube removal ( P = 0.0004 ) . In total , 56 and 78 % of patients reported static and dynamic pain scores improvement and 67 % showed an FEV1 improvement after the chest tube removal . Similar results were observed in patients operated on through VATS or thoracotomy . Compared with patients whose chest tube was removed later , those who had their chest tube removed before post operative day 3 ( POD3 ) , showed a greater reduction in the static pain score ( 41 vs. 31 % , P = 0.05 ) and greater improvement in FEV1 ( 18 vs. 0.01 % , P = 0.02 ) . CONCLUSIONS The removal of a chest tube reduces pain and improves ventilatory function , independent of surgical access and particularly in the early post-operative phase . A fast track chest tube removal policy may favour patients ' recovery",
"Background . Goal -directed fluid therapy ( GDT ) guided by functional parameters of preload , such as stroke volume variation ( SVV ) , seems to optimize hemodynamics and possibly improves clinical outcome . However , this strategy is believed to be rather fluid aggressive , and , furthermore , during surgery requiring thoracotomy , the ability of SVV to predict volume responsiveness has raised some controversy . So far it is not known whether GDT is associated with pulmonary fluid overload and a deleterious reduction in pulmonary function in thoracic surgery requiring one-lung-ventilation ( OLV ) . Therefore , we assessed the perioperative course of extravascular lung water index ( EVLWI ) and paO2/FiO2-ratio during and after thoracic surgery requiring lateral thoracotomy and OLV to evaluate the hypothesis that fluid therapy guided by SVV results in pulmonary fluid overload . Methods . A total of 27 patients ( group T ) were enrolled in this prospect i ve study with 11 patients undergoing lung surgery ( group L ) and 16 patients undergoing esophagectomy ( group E ) . Goal -directed fluid management was guided by SVV ( SVV EVLWI was measured at all predefined steps . The paO2/FiO2-ratio was determined at each point during mechanical ventilation ( group L : BL-OLVterm15 ; group E : BL-24postop ) . Results . In all patients ( group T ) , there was no significant change ( P > 0.05 ) in EVLWI during the observation period ( BL : 7.8 ± 2.5 , 24postop : 8.1 ± 2.4 mL/kg ) . A subgroup analysis for group L and group E also did not reveal significant changes of EVLWI . The paO2/FiO2-ratio decreased significantly during the observation period ( group L : BL : 462 ± 140 , OLVterm15 : 338 ± 112 mmHg ; group E : BL : 389 ± 101 , 24postop : 303 ± 74 mmHg ) but remained > 300 mmHg except during OLV . Conclusions . SVV-guided fluid management in thoracic surgery requiring lateral thoracotomy and one-lung ventilation does not result in pulmonary fluid overload . Although oxygenation was reduced , pulmonary function remained within a clinical ly acceptable range",
"OBJECTIVE Patients undergoing esophagectomy are typically nutritionally depleted and can not establish oral feeding for up to a week after surgery . We have investigated the routine use of enteral feeding via a naso-jejunal tube . METHODS Forty consecutive patients undergoing a transthoracic esophagectomy for cancer were r and omised to receive enteral feeding or intravenous crystalloid fluids after surgery . Nutritional indices were obtained prior to surgery and on the 7th post-operative day . RESULTS There were no post-operative deaths . Non-fatal complications occurred in 10 patients , without difference in morbidity between the two groups . Lean body mass did not change in either group over the study period . No differences in any other parameters were identified between the two groups . CONCLUSION Enteral feeding via a naso-jejunal tube is safe and well tolerated after esophagectomy . It is a simple method of providing nutritional support prior to the re- introduction of oral feeding . However it provides no measurable benefit over intravenous hydration only for patients undergoing routine esophagectomy",
"UNLABELLED The reliability of preemptive analgesia is controversial . Its effectiveness may vary among anatomical areas or surgical types . We evaluated preemptive analgesia by epidural morphine in six surgery types in a r and omized , double-blind manner . Pain intensity was rated using a visual analog scale , a verbal report , and a measurement of postsurgical morphine consumption . Preemptive analgesia was effective in limb surgery and mastectomy , but ineffective for gastrectomy , hysterectomy , herniorrhaphy , and appendectomy . Relief of postsurgical pain in hemiorrhaphy was more rapid than that in the other surgery types . Preemptive analgesia was effective in limb surgery and mastectomy , but not in surgeries involving laparotomy , regardless of whether the surgery was major ( gastrectomy and hysterectomy ) or minor ( herniorrhaphy and appendectomy ) . These results suggest that viscero-peritoneal nociception is involved in postsurgical pain . The abdominal viscera and peritoneum are innervated both heterosegmentally ( in duplicate or triplicate by the vagus and /or phrenic nerves ) and segmentally ( by the spinal nerves ) . Therefore , supraspinal and /or cervical spinal neurons might be sensitized , despite the blockade of the segmental nerves with epidural morphine . The rapid retreat of the pain after hemiorrhaphy suggests that central sensitization remits soon after minor surgery , but that in appendicitis , it may be protracted by additional noxious stimuli , such as infection . IMPLICATION S Epidural preemptive analgesia was reliably effective in limb and breast surgeries but ineffective in abdominal surgery , suggesting involvement of the brainstem and cervical spinal cord via the vagus and phlenic nerves",
"Introduction Goal -directed therapy ( GDT ) has been shown to improve outcome when commenced before surgery . This requires pre-operative admission to the intensive care unit ( ICU ) . In cardiac surgery , GDT has proved effective when commenced after surgery . The aim of this study was to evaluate the effect of post-operative GDT on the incidence of complications and duration of hospital stay in patients undergoing general surgery . Methods This was a r and omised controlled trial with concealed allocation . High-risk general surgical patients were allocated to post-operative GDT to attain an oxygen delivery index of 600 ml min-1 m-2 or to conventional management . Cardiac output was measured by lithium indicator dilution and pulse power analysis . Patients were followed up for 60 days . Results Sixty-two patients were r and omised to GDT and 60 patients to control treatment . The GDT group received more intravenous colloid ( 1,907 SD ± 878 ml versus 1,204 SD ± 898 ml ; p dopexamine ( 55 patients ( 89 % ) versus 1 patient ( 2 % ) ; p Fewer GDT patients developed complications ( 27 patients ( 44 % ) versus 41 patients ( 68 % ) ; p = 0.003 , relative risk 0.63 ; 95 % confidence intervals 0.46 to 0.87 ) . The number of complications per patient was also reduced ( 0.7 SD ± 0.9 per patient versus 1.5 SD ± 1.5 per patient ; p = 0.002 ) . The median duration of hospital stay in the GDT group was significantly reduced ( 11 days ( IQR 7 to 15 ) versus 14 days ( IQR 11 to 27 ) ; p = 0.001 ) . There was no significant difference in mortality ( seven patients ( 11.3 % ) versus nine patients ( 15 % ) ; p = 0.59 ) . Conclusion Post-operative GDT is associated with reductions in post-operative complications and duration of hospital stay . The beneficial effects of GDT may be achieved while avoiding the difficulties of pre-operative ICU admission",
" This study evaluates the efficiency and safety of two methods of chest drainage after uncomplicated oesophagectomy",
"OBJECTIVE Thoracoabdominal esophagectomy is a major surgical procedure that carries significant postoperative morbidity and mortality . Because the choice of analgesic technique may influence outcome , the impact of thoracic epidural or intravenous analgesia was investigated after esophagectomy . DESIGN Prospect i ve observational study during January 1996 until January 2002 . SETTING University hospital . PARTICIPANTS All patients undergoing thoracoabdominal esophagectomy during the 6-year period . INTERVENTIONS Patients were prospect ively monitored during a 6-year period . Duration of surgery , intraoperative blood loss , fluid administration , postoperative intubation time , intensive care unit ( ICU ) stay , pain relief and related side effects , postoperative complications , hospital stay , and in-hospital and long-term mortality were compared in relation with the analgesic technique . MEASUREMENTS AND MAIN RESULT Thoracic epidural analgesia with bupivacaine/morphine was used in 166 patients , and intravenous morphine analgesia was used in 35 patients . Postoperative intubation time and ICU stay were similar in both groups . Patients with epidural analgesia experienced less pain . Sedation , respiratory depression , hallucinations , and confusion were more common in the intravenous morphine group . Postoperative weight did not differ between the groups , despite fluid replacement that was higher in the epidural group during the first 24 hours . The in-hospital mortality rate was 0.5 % . CONCLUSIONS No differences in morbidity/mortality rates depending on analgesic treatment were observed in patients undergoing thoracoabdominal esophagectomy . Thoracic epidural analgesia provided better pain relief with fewer opioid-related side effects than intravenous morphine analgesia . However , postoperative epidural analgesia was associated with more technical difficulties",
"BACKGROUND The optimal management of the pylorus during esophagogastrectomy is unknown . Pyloromyotomy and pyloroplasty cause early edema and risk long-term bile reflux ; however , the lack of pyloric drainage might risk early aspiration . METHODS We performed a retrospective study with a prospect i ve data base on patients with esophageal cancer or high- grade dysplasia who underwent Ivor-Lewis esophagogastrectomy . All had one surgeon and similar stomach tubularization , h and -sewn anastomoses , nasogastric tube duration , and postoperative prokinetic agents . Outcomes of postoperative gastric emptying , aspiration , and swallowing symptoms were compared . RESULTS Between January 1997 and June 2008 , there were 221 patients . Seventy-one patients had a pyloromyotomy , and gastric emptying judged on postoperative day 4 was delayed in 93 % ( 52 % had any morbidity and 14 % had respiratory morbidity ) . Fifty-four patients had no drainage procedure , and gastric emptying was delayed in 96 % ( 59 % had any morbidity and 22 % had respiratory morbidity ) . Twenty-eight patients underwent pyloroplasty , and 96 % had delayed gastric emptying ( 50 % had any morbidity and 32 % had respiratory morbidity ) . Sixty-eight patients had botulinum toxin injection into the pylorus . Gastric emptying was delayed in only 59 % ( P = .002 , 44 % had any morbidity and 13 % had respiratory morbidity ) . Hospital length of stay ( P = .015 ) and operative times ( P = .037 ) were shorter in the botulinum toxin group . Follow-up ( mean , 40 months ) showed symptoms of biliary reflux to be lowest in the botulinum toxin group ( P = .024 ) . CONCLUSION Injection of the pylorus with botulinum toxin at the time of esophagogastrectomy is safe and decreases operative time when compared with pyloroplasty or pyloromyotomy . In addition , it can improve early gastric emptying , decrease respiratory complications , shorten hospital stay , and reduce late bile reflux . A prospect i ve multi-institutional r and omized trial is needed",
"BACKGROUND Epidural analgesia is widely used for efficient pain relief after major surgery . However , it may cause urinary retention , leading to delayed removal of bladder catheters with prolonged patient discomfort . Using a specific regimen in patient controlled epidural analgesia ( PCEA ) , we examined the optimal duration of urinary catheterization in patients undergoing major thoracic surgery . METHODS Seventy-eight patients scheduled for elective thoracotomy were prospect ively r and omized into two groups : Group 1 , removal of the transurethral catheter on the first postoperative day ( n = 38 ) ; Group 2 , removal of the catheter after discontinuation of PCEA ( n = 40 ) . The PCEA regimen was a mixture containing low-dose morphine , bupivacaine and neostigmine and was given for 3 days after surgery in all subjects . Micturition problems , pain scores assessed by the visual analog scale ( VAS ) , and side effects were evaluated during and after PCEA treatment . RESULTS The average duration of urinary drainage after surgery was 30.2 + or - 5.1 hours and 78.5 + or - 7.3 hours in Groups 1 and 2 , respectively . After removal of the bladder catheter , no patient in either group required re-catheterization for urinary retention or encountered catheter-related infection . VAS scores were significantly lower in Group 1 at rest and at 24 , 36 and 48 hours after cessation of PCEA . VAS scores were significantly higher in Group 2 patients , possibly due to catheter-induced pain related to prolonged catheterization . CONCLUSION Routine continuous bladder catheterization may not necessarily be required after thoracotomy in patients with ongoing continuous thoracic epidural analgesia",
"OBJECTIVE To evaluate audiotape-recorded consultations at which a new diagnosis of oesophageal or gastric cancer was given to patients with reference to information retention , psychological outcome and socio-economic deprivation . METHODS Fifty-eight patients were r and omised to receive audiotaped consultations or not . Thirty-one patients received tapes ( 12 oesophageal and 19 gastric cancers ) and were compared with 27 control patients ( 12 oesophageal and 15 gastric cancers ) . All patients were re-interviewed and completed a hospital anxiety and depression ( HAD ) question naire . Socio-economic deprivation scores were calculated using National Indices of Multiple Deprivation . RESULTS Patients r and omised to receive tapes were more likely to retain information ( 31 patients ) than control patients ( 18 patients , p=0.001 ) . Median ( range ) HAD scores were similar in both groups of patients [ HAD A tape 6 ( 0 - 21 ) vs. no tape 5 ( 2 - 14 ) , HAD D tape 3 ( 0 - 23 ) vs. 4 ( 0 - 10 ) , respectively ] . Deprivation correlated significantly with higher HAD A scores in control patients ( p=0.039 ) but was not associated with information retention ( p=0.667 ) . CONCLUSION Taped consultations were associated with significantly better information retention without adverse psychological outcomes . Providing an audiotape may reduce the effect of socio-economic deprivation on patient anxiety . PRACTICE IMPLICATION S Audiotaping , or its equivalent , would be a valuable tool in the multidisciplinary approach to cancers of the upper gastrointestinal tract",
"Background Colorectal cancer patients are often anemic before surgery , and this leads to an increased requirement for allogeneic blood transfusion . This may result in transfusion-induced immunosuppression , which in turn leads to increased morbidity and possibly an increased rate of tumor relapse . We investigated the possible benefits of perioperative epoetin alfa administration in anemic patients to correct hemoglobin levels and reduce transfusion needs . Methods A total of 223 colorectal cancer patients with anemia scheduled for surgery were r and omized to a group that received epoetin alfa 150 or 300 IU/kg/day subcutaneously for 12 days ( day -10 to + 1 ) or to a control group . All received iron ( 200 mg/day by mouth ) for 10 days before surgery . Hemoglobin levels , hematocrit , and the number of blood units transfused were recorded . Results A total of 204 patients were eligible for analysis . Mean hemoglobin levels and hematocrit were significantly higher in the 300 IU/kg group than in the control group , both 1 day before surgery ( hemoglobin , P = .008 ; hematocrit , P = .0005 ) and 1 day after surgery ( hemoglobin , P = .011 ; hematocrit , P = .0008 ) . Blood loss during and after surgery was similar in all groups . Patients who received epoetin alfa 300 IU/kg required significantly fewer perioperative transfusion units than control patients ( .81 vs. 1.32 ; P = .016 ) and significantly fewer postoperative units ( .87 vs. 1.33 ; P = .023 ) . There were no significant differences in the number of units in the 150 IU/kg group . Conclusions Preoperative epoetin alfa ( 300 IU/day ) increases hemoglobin levels and hematocrit in colorectal surgery patients . These effects are associated with a reduced need for perioperative and postoperative transfusions",
"Background and Objectives Postoperative urinary retention may occur in between 10 % and 60 % of patients after major surgery . Continuous lumbar epidural analgesia , in contrast to thoracic epidural analgesia , may inhibit urinary bladder function . Postoperative urinary drainage has been common in patients with continuous epidural analgesia , despite the lack of scientific evidence for its indication after thoracic epidural analgesia . This study describes 100 patients who underwent elective colonic resection with 48 hours of continuous thoracic epidural analgesia and only 24 hours of urinary drainage . Methods This is a prospect i ve , uncontrolled study with well-defined general anesthesia , postoperative analgesia , and nursing care programs in patients with a planned 2-day hospital stay , urinary catheter removal on the first postoperative morning , and epidural catheter removal on the second postoperative morning . Follow-up in the outpatient clinic was on days 8 and 30 . Results Nine patients needed bladder recatheterization , 8 as a single procedure and 1 patient a second recatheterization with removal on day 7 . This patient had urinary infection on day 10 and was readmitted for 5 days because of urosepsis and , subsequently , for cystitis and left-sided epididymitis . Three patients had uncomplicated urinary infection . No patients had urological complaints at 30 days follow-up ( 95 % confidence limit , 0 % to 3.6 % ) . Conclusion The low incidence of urinary retention ( 9 % ) and urinary infection ( 4 % ) suggests that routine bladder catheterization beyond postoperative day 1 may not be necessary in patients with ongoing continuous low-dose thoracic epidural analgesia",
"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",
"OBJECTIVE To compare postoperative pain relief and pulmonary function in patients after thoracoabdominal esophagectomy treated by continuing perioperative thoracic epidural anesthesia or changing to parenteral opioids . DESIGN Prospect i ve , r and omized study . SETTING University teaching hospital . PARTICIPANTS Thirty-three patients undergoing thoracoabdominal esophagectomy . INTERVENTIONS General anesthesia was combined with thoracic epidural anesthesia during surgery . The patients either continued with thoracic epidural analgesia ( n = 18 ) or were switched to patient-controlled analgesia with intravenous morphine ( n = 15 ) for 5 postoperative days . Pain scores were estimated twice daily , at rest and after mobilization . Peak expiratory flow , forced expiratory volume , and vital capacity were measured the day before surgery , postoperative day 2 , and postoperative day 6 . Adverse events and complications were recorded . MEASUREMENTS AND MAIN RESULTS At rest , there were no differences in pain relief between the groups . Pain scores at mobilization showed a significantly lower value in the epidural group ( p pulmonary function , which decreased on postoperative day 2 , but was improved on postoperative day 6 . CONCLUSION Continuation of intraoperative thoracic epidural anesthesia for 5 postoperative days provides better pain relief at mobilization compared with a switch to patient-controlled analgesia with intravenous morphine . There was no intergroup difference in the impact on measures of pulmonary function",
"BACKGROUND We commonly use needle catheter jejunostomy ( NCJ ) for early enteral feeding in selected patients . Review of our approach was prompted by the suggestion that enteral feeding represents a \" stress test \" for the bowel and may be associated with a high complication rate . MATERIAL S AND METHODS We review ed patients with NCJ inserted over the past 16 years by prospect i ve data base , chart review , and conference minutes , with emphasis on complications . RESULTS During the conduct of 28,121 laparotomies , 2,022 NCJs inserted in 1,938 patients ( 7.2 % ) result ed in 34 NCJ-related complications in 29 patients ( 1.5 % ) The most common complication was premature loss of the catheter from occlusion or dislodgment ( n = 15 ; 0.74 % ) , and the most serious was bowel necrosis ( n = 3 ; 0.15 % ) . CONCLUSIONS Needle catheter jejunostomy may be inserted and used with a low complication rate . Most complications were preventable through greater attention to detail and better monitoring of physical examination of patients with marginal gut function",
"AIM Recent evidence suggests that the provision of energy-containing fluids is safe and may impact positively on markers of recovery . The aims of this study were to assess the tolerance of preoperative carbohydrate fluid administration and to determine its effect on postoperative metabolic and clinical responses . METHODS Patients admitted to the Royal Infirmary of Edinburgh for major , elective abdominal surgery were recruited to this double-blind , r and omised study and received either a placebo drink or carbohydrate ( 12.6g/100ml ) drink ( CHOD ) . Patients consumed 800 ml of their drink on the evening before surgery and 400 ml on the day of surgery 2 - 3 h before the induction of anaesthesia . Nutritional status was determined using body mass index ( BMI ) and upper arm anthropometry ; all measurements were taken preoperatively , postoperatively and at discharge . Blood glucose and insulin concentrations were also measured preoperatively and on the first post operative day . Length of hospital stay ( LOS ) and postoperative complications were recorded . RESULTS Seventy-two patients were recruited and 65 ( 34 male:31 female ) completed this study . Thirty-four patients were r and omised to receive the placebo drink ( control group ) and 31 patients to receive the carbohydrate drink ( CHOD group ) . Groups were well-matched in terms of gender and age . There were no differences between the two groups at baseline for BMI ( control : -25.1+/-1.7 kg/m2 ; CHOD -25.2+/-1.2 kg/m2 ) , upper arm anthropometry or surgical procedure . At discharge loss of muscle mass ( arm muscle circumference ) was significantly greater in the control group when compared with the CHOD group ( control : -1.1+/-0.15 cm ; CHOD : -0.5+/-0.16 cm ; P Baseline insulin ( control : 20.7+/-4.9 mU/l ; CHOD : 24.6+/-6.2 mU/l ) and glucose ( control : 6.0+/-1.4 mmol/l ; CHOD 5.7+/-1.4 mmol/l ) were comparable in the two groups and did not differ postoperatively . No complications were recorded as a result of preoperative fluid consumption . Postoperative morbidity occurred in six patients from each group . Median LOS in the control group was 10 days ( IQR=6 ) , and 8 days ( IQR=4 ) in the CHOD group . CONCLUSION Preoperative consumption of carbohydrate-containing fluids is safe . Provision of a carbohydrate energy source prior to surgery may attenuate depletion of muscle mass after surgery . Further studies are required to determine if this preservation of muscle mass is reflected in improved function and reduced rehabilitation time",
"OBJECTIVES We prospect ively analyzed the association between drainage volume and development of complications to clarify the safety of early removal of chest tube after thoracoscopic lobectomy . METHODS Between November 2001 and October 2007 , 136 patients with suspected or histologically documented lung cancer were enrolled . Patients with no air leak and increased drainage underwent removal of the chest tube on the day after thoracoscopic lobectomy independent of the drainage volume . Patients were classified into three groups as tertiles according to the drainage volume . Demographic and perioperative variables were compared among the three groups . Age-sex adjusted odds ratios of the clinical variables associated with development of complications were estimated . In addition , the odds ratios of the drainage volume for development of complications were estimated after adjusting for potentially important factors . RESULTS One hundred patients underwent early removal of the chest tube . Almost all demographic and perioperative variables showed no differences among the three groups ( 0 - 289 mL , n = 33 ; 290 - 399 mL , n = 33 ; and > or=400 mL , n = 34 ) . Tumors in a lower lobe , preoperative stage II or higher , 5 or more anatomic segments resected , and advanced disease were all factors that were associated with higher odds ratios for complications . The drainage volume was not associated with an increased morbidity , even after adjusting for these factors . CONCLUSIONS Early removal of chest tube on the day after thoracoscopic lobectomy , independently of the drainage volume , appears to be safe in well-selected patients",
"Abstract This study was conducted to determine the effects of immediate enteral nutrition ( EN ) on nutritional status , immunological competence , and the suppression of excessive inflammatory responses in patients following esophageal cancer surgery . Twenty-four patients who underwent the same elective operation for thoracic esophageal carcinoma were r and omized into an immediate enteral nutrition ( IEN ) group who received EN from postoperative day ( POD ) 1 and a parenteral nutrition ( PAN ) group . Both groups received comparable volumes and calories on the same POD . Laboratory studies were carried out preoperatively and on PODs 1–7 . Other nutritional and immunological assessment s were repeated on PODs 1 and 7 . Plasma concentrations of nitrate and nitrite were also measured . All of the patients in the IEN group tolerated enteral feeding well . There were no significant differences in the results of nutritional assessment s , lymphocyte function , or plasma nitrate and nitrite levels between the two groups . The IEN group showed a significantly earlier recovery of the total lymphocyte count . The serum levels of total bilirubin and C-reactive protein were significantly attenuated in the IEN group . These results indicate that immediate EN may have beneficial effects on immunological competence and the suppression of excessive inflammatory responses in patients following esophagectomy . Patients undergoing radical esophageal surgery who are subjected to severe surgical stress might benefit the most from early EN",
"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",
"BACKGROUND Surgical resection is regarded as the only curative option for resectable oesophageal cancer , but pulmonary complications occurring in more than half of patients after open oesophagectomy are a great concern . We assessed whether minimally invasive oesophagectomy reduces morbidity compared with open oesophagectomy . METHODS We did a multicentre , open-label , r and omised controlled trial at five study centres in three countries between June 1 , 2009 , and March 31 , 2011 . Patients aged 18 - 75 years with resectable cancer of the oesophagus or gastro-oesophageal junction were r and omly assigned via a computer-generated r and omisation sequence to receive either open transthoracic or minimally invasive transthoracic oesophagectomy . R and omisation was stratified by centre . Patients , and investigators undertaking interventions , assessing outcomes , and analysing data , were not masked to group assignment . The primary outcome was pulmonary infection within the first 2 weeks after surgery and during the whole stay in hospital . Analysis was by intention to treat . This trial is registered with the Netherl and s Trial Register , NTR TC 2452 . FINDINGS We r and omly assigned 56 patients to the open oesophagectomy group and 59 to the minimally invasive oesophagectomy group . 16 ( 29 % ) patients in the open oesophagectomy group had pulmonary infection in the first 2 weeks compared with five ( 9 % ) in the minimally invasive group ( relative risk [ RR ] 0·30 , 95 % CI 0·12 - 0·76 ; p=0·005 ) . 19 ( 34 % ) patients in the open oesophagectomy group had pulmonary infection in-hospital compared with seven ( 12 % ) in the minimally invasive group ( 0·35 , 0·16 - 0·78 ; p=0·005 ) . For in-hospital mortality , one patient in the open oesophagectomy group died from anastomotic leakage and two in the minimally invasive group from aspiration and mediastinitis after anastomotic leakage . INTERPRETATION These findings provide evidence for the short-term benefits of minimally invasive oesophagectomy for patients with resectable oesophageal cancer . FUNDING Digestive Surgery Foundation of the Unit of Digestive Surgery of the VU University Medical Centre",
"BACKGROUND There appears to be an emerging consensus that early postoperative nutritional support benefits the high-risk patient by decreasing septic morbidity , maintaining immunocompetence and improving wound healing . Enteral nutrition via a feeding jejunostomy has been associated with serious complications , with a reported mortality rate as high as 10 % , while total parenteral nutrition has also been associated with a wide variety of complications . METHODS Ninety-seven patients undergoing oesophagectomy or gastrectomy underwent pre-operative nutritional assessment and were r and omized to receive either total parenteral nutrition ( 47 patients ) or enteral nutrition ( 50 patients ) . RESULTS There was no significant difference in the number of catheter-related complications between the two groups , but 9 ( 45 % ) patients in the total parenteral nutrition group had major morbidity ( potentially fatal in two patients ) requiring active intervention . CONCLUSIONS This study demonstrates enteral nutrition to be safe and associated with mainly reversible minor complications . It is probable that immediate postoperative enteral feeding conserves the gut 's integrity . Whether this leads to a reduction in postoperative septic complications has not been demonstrated by this study although there appears to be a trend in this direction , supporting the concept of enteral feeding as ' primary therapy ' . This can be safely , simply and economically achieved using a feeding jejunostomy placed at the time of surgery",
"OBJECTIVE Many patients have their hospital discharge delayed because their chest tube drainage is too high , despite the fact that there are no data to support the commonly used 250 mL/day threshold . METHODS A retrospective cohort study was conducted with a prospect i ve data base and prospect i ve algorithm from one surgeon . All patients underwent elective pulmonary resection . The last chest tube was removed if there was no air leak and nonchylous drainage of 450 mL/day or less . RESULTS The study comprised 8608 operations and 2077 patients who underwent an elective ( nonpneumonectomy ) pulmonary resection via thoracotomy by one general thoracic surgeon over a 10-year period . Eighty-nine patients went home with a chest tube owing to air leak . The remaining 1988 patients were discharged without a chest tube . Types of pulmonary resection were wedge resection in 729 patients , segmentectomy in 214 , lobectomy in 1104 , and bilobectomy in 30 . The median day of discharge was postoperative day 4 . One hundred one ( 5 % ) were readmitted to the hospital within 60 days of discharge . The most common reason for readmission was dehydration and fatigue . Only 11 ( 0.55 % ) had readmissions owing to recurrent symptomatic effusion and most were treated with video-assisted thoracoscopy . Follow-up was 100 % at 4 weeks and 93 % at 8 weeks . CONCLUSIONS Chest tubes can be removed with up to 450 mL/day of nonchylous drainage after pulmonary resection , and perhaps a higher volume could be accepted . Readmission owing to a recurrent effusion is exceedingly uncommon , and the practice of leaving the tube in longer for drainage less than 450 mL/day is unsupported in the literature",
"Objective This study seeks to evaluate the level of anxiety , recall , and comprehension of the provided information in patients undergoing esophageal and gastrointestinal surgery . Methods Sixty-one patients without cognitive disorders entered a prospect i ve study design ed to assess the effect of a surgical informed consent process . The written informed consent was administered to all patients and was supported by a verbal explanation and a schematic drawing of the operation . The State Trait Anxiety Inventory test was used to assess state anxiety and tract anxiety . The test was repeated after the informed consent process . A disease-specific feedback question naire was subsequently administered to assess the actual comprehension of the provided information . Results A significant decrease of the state anxiety scores was documented in most patients ( p elderly ( p = 0.021 ) and in those who used Internet as a previous source of information ( p = 0.032 ) . The mean correct exact answer rate on the disease-specific question naire was 76 % ( IQ range 66.7–85 % ) . No statistically significant relationship was found between the rate of correct answers and the state anxiety scores . Conclusions An exhaustive surgical informed consent process was effective in providing comprehension and decreasing anxiety in patients who are c and i date s to minimally invasive esophageal and gastrointestinal surgical procedures",
"BACKGROUND The provision of perioperative immune modulating enteral feeds after major surgery may result in reduced infective complications , but meta-analyses have not demonstrated a survival advantage . The aim of this study was to determine whether early postoperative immune modulating jejunostomy feeding results in reduced infective complications in patients undergoing resectional surgery for upper gastrointestinal cancer . METHODS A total of 120 patients undergoing resection for cancers of the pancreas , oesophagus and stomach were r and omized in a double-blind manner to receive jejunostomy feeding with an immune modulating diet ( Stresson-Group A ) or an isonitrogenous , isocaloric feed ( 1250 Calories and 75 g protein/l -- Nutrison High Protein-Group B ) for 10 - 15 days . Feeding was commenced 4h postoperatively and continued for 20 h/day . The target volume ( ml/h ) was 25 on day 0 , 50 on day 1 , and 75 thereafter . Outcome measures included complications , hospital stay and mortality . RESULTS A total of 108 patients ( 54 in each group ) were analysed . Feed delivery , although less than targeted , was similar in both groups . There were 6 ( 11 % ) deaths in each group . Median ( IQR ) postoperative hospital stay was 14.5 ( 12 - 23 ) days in Group A and 17.5 ( 13 - 23 ) days in Group B ( P=0.48 ) . A total of 24 ( 44 % ) patients in each group had infective complications ( P=1.0 ) . A total of 21 ( 39 % ) patients in Group A and 28 ( 52 % ) in Group B had non-infective complications ( P=0.18 ) . Jejunostomy-related complications occurred in 26 ( 48 % ) patients in Group A and 30 ( 56 % ) in Group B ( P=0.3 ) . CONCLUSION Early postoperative feeding with an immune modulating diet conferred no outcome advantage when compared with a st and ard feed",
"Feeding jejunostomy is frequently performed in patients undergoing oesophageal surgery , but can lead to serious complications . This prospect i ve r and omized trial compared the efficacy and complications of feeding jejunostomy with those of nasoduodenal tube feeding in oesophageal surgery",
"Purpose : Water-soluble contrast swallow ( CS ) is usually performed before refeeding for anastomosis assessment after esophagectomy with intrathoracic anastomosis but the sensitivity of CS is low . Another diagnostic approach is based on analysis of computed tomography ( CT ) scan with oral contrast and of CT mediastinal air images . We undertook to compare them prospect ively . Methods : Ninety-seven patients with an esophageal carcinoma operated by intrathoracic anastomosis were included prospect ively in a study based on a CT scan at postoperative day 3 ( without oral and intravenous contrast ) and CT scan and CS at day 7 . CT scan analysis consisted of assessing contrast and air leakage . In case of doubt , an endoscopy was done . Results : A diagnosis of anastomotic leak was made in 13 patients ( 13.4 % ) , in 2 cases before day 7 and in 3 beyond day 7 . At day 3 , 94 CT scans were performed , but the diagnostic value was poor . In 95 patients with both CS and CT scan at day 7 , CS disclosed a leak in 5 of 11 , and CT scan was abnormal in 8 of 11 . Leakage of contrast and /or presence of mediastinal gas had the best negative predictive value ( 95.8 % ) . Endoscopy was done in 16 patients with only mediastinal gas at day 7 CT scan . It disclosed a normal anastomosis in 11 , fibrin deposits in 4 , and a leak in 1 . Conclusions : In comparison with CS only , CT at day 7 improves the sensitivity and negative predictive value for diagnosing an anastomotic leak . In case of doubt endoscopy is advisable . This approach provides an accurate assessment of the anastomosis before refeeding",
"Objective To investigate the effect of recombinant human erythropoietin ( r-HuEPO ) administration on perioperative hemoglobin concentrations and on the number of blood transfusions in patients undergoing surgery for gastrointestinal tract malignancies . Summary Background Data Erythropoietin has been shown to improve the yield of autologously predonated blood and to reduce the subsequent requirements for homologous blood transfusions in cancer patients . Methods In this double-blind placebo-controlled study , 31 cancer patients received subcutaneous r-HuEPO in a dose of 300 IU/kg body weight plus 100 mg iron intravenously ( study group ) and 32 patients received placebo medication and iron ( control group ) . All patients received the medications daily for at least 7 days before and 7 days after the operation . Results Patients who received erythropoietin received significantly fewer transfusions intraoperatively and postoperatively . Postoperatively , the study group had significantly higher hematocrit , hemoglobin , and reticulocyte count values compared to the control group . The use of erythropoietin was also associated with a reduced number of postoperative complications and improved 1-year survival . Conclusions Patients with gastrointestinal tract cancer and mild anemia benefit from perioperative erythropoietin administration in terms of stimulated erythropoiesis , reduction in the number of blood transfusions , and a favorable outcome ",
"BACKGROUND Anastomotic leaks are a major complication of oesophagogastric surgery . We compare contrast swallow fluoroscopy , computed tomography ( CT ) with oral contrast and endoscopy in identifying anastomotic leaks following oesophagogastric surgery . METHODS A prospect i ve trial of 38 patients undergoing oesophagogastric resection was undertaken with informed consent and institutional review board ( ethics committee ) approval . Patients underwent all three investigations ( over 24 hours ) 1 week postoperatively . RESULTS Eight ( 21 % ) had clinical ly apparent leaks . Three pseudo-leaks were suggested on contrast swallow but were confirmed normal on CT and endoscopy . Contrast swallow and CT missed one anastomotic leak each . Endoscopy identified anastomotic defects in three patients , in whom CT and contrast swallow were either normal or conflicting . CONCLUSIONS Routine tests of anastomotic integrity are unnecessary . When clinical ly suspected , contrast swallow or CT with oral contrast will identify most leaks . Endoscopy is useful in cases where there are incongruous results",
"BACKGROUND : Gastric tube necrosis is a major cause of anastomotic leak after esophagectomy . A correlation has been shown between reduced flux at the anastomotic end of the gastric tube and anastomotic leaks . METHODS : We prospect ively studied the effect of intraoperative thoracic epidural bupivacaine and subsequent adrenaline infusion on hemodynamics and flux in the gastric tube . RESULTS : Administering the epidural bolus significantly decreased flux at the anastomotic end of the gastric tube ( P Gastric flux was returned to baseline by an adrenaline infusion . CONCLUSIONS : The administration of a thoracic epidural bolus may decrease flux at the anastomotic end of the gastric tube",
"INTRODUCTION Allogeneic blood transfusion confers a risk to the recipient . Recent trials in colorectal surgery have shown that the most significant factors predicting blood transfusion are pre-operative haemoglobin , operative blood loss and presence of a transfusion protocol . We report a r and omised , controlled trial of oral ferrous sulphate 200 mg TDS for 2 weeks ' pre-operatively versus no iron therapy . PATIENTS AND METHODS Patients diagnosed with colorectal cancer were recruited from out-patient clinic and haematological parameters assessed . R and omisation was co-ordinated via a telephone r and omisation centre . RESULTS Of the 49 patients recruited , 45 underwent colorectal resection . There were no differences between those patients not receiving iron ( n = 23 ) and the iron-supplemented group ( n = 22 ) for haemoglobin at recruitment , operative blood loss , operation duration or length of hospital stay . At admission to hospital , the iron-supplemented group had a higher haemoglobin than the non-iron treated group ( mean haemoglobin concentration 13.1 g/dl [ range , 9.6 - 17 g/dl ] versus 11.8 g/dl [ range , 7.8 - 14.7 g/dl ] ; P = 0.040 ; 95 % CI 0.26 - 0.97 ) and were less likely to require operative blood transfusion ( mean 0 U [ range , 0 - 4 U ] versus 2 U [ range , 0 - 11 U ] transfused ; P = 0.031 ; 95 % CI 0.13 - 2.59 ) . This represented a cost reduction of 66 % ( 47 U of blood = pound4700 versus oral FeSO(4 ) at pound30 + 15 U blood at pound1500 ) . At admission , ferritin in the iron-treated group had risen significantly from 40 microg/l ( range , 15 - 222 microg/l ) to 73 microg/l ( range , 27 - 386 microg/l ; P = 0.0036 ; 95 % CI 46.53 - 10.57 ) . CONCLUSIONS Oral ferrous sulphate given pre-operatively in patients undergoing colorectal surgery offers a simple , inexpensive method of reducing blood transfusions",
"AIM Assessing the impact of chest tube removal timing following a coronary artery bypass grafting surgery on the clinical outcome . METHODS Eighty-three consecutive patients were r and omly assigned to either have the chest tube removed 24 hours ( Group A ) or 48 hours ( Group B ) postoperatively . Chest tubes were removed on the condition that drainage was less than 100 cc for the last 8 hours . Pre- and postoperative data were analyzed . RESULTS The following preoperative and intraoperative risk factors were more prevalent among Group A patients : previous MI ( 60.5 % vs 40.7 % , p = 0.11 ) , previous CVA ( 9.1 % vs 0 % , p = 0.11 ) , hypertension ( 72.7 % vs 55.6 % , p = 0.14 ) , pump time ( 111.6 min vs 96.8 min , p = 0.07 ) , and cross-clamp time ( 73.8 min vs 64.4 min , p = 0.07 ) . Postoperatively , there was a lower dem and for analgesics in Group A ( 2.1 times for 12 hours at 36 hours vs 3.6 p = 0.09 ) , lower white blood cell count ( 10,947 at 48 hours vs 11,576 , p = 0.39 ) a higher oxygen saturation ( 91.9 % at 48 hours vs 88.9 % , p = 0.07 ) , higher expiratory volumes ( 594 mL at 36 hours vs 514 mL p = 0.08 ) and earlier mobilization ( 23 % walking at 48 hours vs 4 % , p = 0.01 ) . Pleural effusion and atelectasis were less frequent in Group A in both chest X-rays ( 66 % vs 73 % , p = 0.6 and 64 % vs 75 % , p = 0.47 , respectively ) and CT scans ( 19 % vs 41 % , p = 0.1 and 84 % vs 96 % , p = 0.42 , respectively ) . There was no difference between the two groups in the prevalence of serous wound discharge and the length of hospital stay and there were no reported cases of pneumonia throughout the study . CONCLUSION In cases where no excessive drainage accumulates , early removal of the chest tubes was found to be a policy that improves the postoperative outcome and decreases the need for supportive treatment such as analgetics , physiotherapy , nurse care , and oxygen . This policy did not involve significant residual effusions",
"BACKGROUND Postoperative organ failures commonly occur after major abdominal surgery , increasing the utilization of re sources and costs of care . Tissue hypoxia is a key trigger of organ dysfunction . A therapeutic strategy design ed to detect and reverse tissue hypoxia , as diagnosed by an increase of oxygen extraction ( O2ER ) over a predefined threshold , could decrease the incidence of organ failures . The primary aim of this study was to compare the number of patients with postoperative organ failure and length of hospital stay between those r and omized to conventional vs a protocol ized strategy design ed to maintain O2ER nine hospitals in Italy . One hundred thirty-five high-risk patients scheduled for major abdominal surgery were r and omized in two groups . All patients were managed to achieve st and ard goals : mean arterial pressure > 80 mm Hg and urinary output > 0.5 mL/kg/h . The patients of the \" protocol group \" ( group A ) were also managed to keep O2ER organ failure ( n = 8 , 11.8 % ) than in group B ( n = 20 , 29.8 % ) [ p total number of organ failures was lower in group A than in group B ( 27 failures vs 9 failures , p Length of hospital stay was significantly lower in the protocol group than in the control group ( 11.3 + /- 3.8 days vs 13.4 + /- 6.1 days , p Hospital mortality was similar in both groups . CONCLUSIONS Early treatment directed to maintain O2ER at organ failures and hospital stay of high-risk surgical patients . Clinical trials.gov reference No. NCT00254150",
"Background : Nutritional condition is one of the factors determining postoperative outcome in esophageal surgery . This study explored the relation between preoperative nutritional status and postoperative infectious complications . Methods : From a prospect i ve data base , 400 patients who underwent esophageal resection for malignancy were selected . Preoperative nutritional status was assessed by body mass index , prognostic nutritional index ( PNI ) , nutritional risk index ( NRI ) and weight loss . The association between nutritional parameters and postoperative complications and mortality , gender , age and hospitalization was assessed . Results : PNI and NRI differed between the patients with and without postoperative infectious complications ( p = 0.031 and p = 0.009 , respectively ) . However , receiver operating characteristic curves showed that PNI and NRI have a low predictive value for such complications . Also , no associations were found between nutritional parameters and in-hospital mortality . Although mean nutritional parameters were significantly lower , i.e. worse , in patients with neoadjuvant treatment as compared to no such treatment , the incidence of complications did not significantly differ between these treatment groups . Although PNI and NRI correlated negatively with age , no association was found between age and infectious complications . Multivariate analysis of various factors showed the male gender to be the only significant risk factor for development of infectious complications . Discussion : Preoperative nutritional status established by PNI , NRI , body mass index and weight loss has limited value in predicting complications following esophageal resection",
"A carbohydrate‐rich drink ( CHO ) has been shown to reduce preoperative discomfort . It was hypothesized that it may also reduce postoperative nausea and vomiting ( PONV ) ",
"OBJECTIVE The authors set out to determine whether immediate enteral feeding minimizes early postoperative decreases in h and grip and respiratory muscle strength . SUMMARY BACKGROUND DATA Muscle strength decreases considerably after major surgical procedures . Enteral feeding has been shown to restore strength rapidly in other clinical setting s. METHODS A r and omized , controlled , nonblinded clinical trial was conducted in patients undergoing esophagectomy or pancreatoduodenectomy who received immediate postoperative enteral feeding via jejunostomy ( fed , n = 13 ) , or no enteral feeding during the first 6 postoperative days ( unfed , n = 15 ) . H and grip strength , vital capacity , forced expiratory volume in one second ( FEV1 ) , and maximal inspiratory pressure ( MIP ) were measured before surgery and on postoperative days 2 , 4 , and 6 . Fatigue and vigor were evaluated before surgery and on postoperative day 6 . Mobility was assessed daily after surgery using a st and ardized descriptive scale . Postoperative urine biochemistry was evaluated in daily 24-hour collection s. RESULTS Postoperative vital capacity ( p FEV1 ( p = 0.07 ) were consistently lower ( 18%-29 % ) in the fed group than in the unfed group , whereas grip strength and maximal inspiratory pressure were not significantly different . Postoperative mobility also was lower in the fed patients ( p Fatigue increased and vigor decreased after surgery ( both p Intensive care unit and postoperative hospital stay did not differ between groups . CONCLUSIONS Immediate postoperative jejunal feeding was associated with impaired respiratory mechanics and postoperative mobility and did not influence the loss of muscle strength or the increase in fatigue , which occurred after major surgery . Immediate postoperative enteral feeding should not be routine in well-nourished patients at low risk of nutrition-related complications",
"PURPOSE This prospect i ve , nonr and omized study evaluates the effectiveness of epoetin alfa to maintain the hemoglobin levels at 12 to 14 g/dL ( optimal range for tumor oxygenation ) during chemoradiation for Stage III esophageal cancer and its impact on overall survival ( OS ) , metastatic-free survival ( MFS ) , and locoregional control ( LC ) . METHODS AND MATERIAL S Ninety-six patients were included . Forty-two patients received epoetin alfa ( 150 IU/kg , 3 times a week ) during radiotherapy , which was started at hemoglobin less than 13 g/dL and stopped at 14 g/dL or higher . Hemoglobin levels were measured weekly during RT . RESULTS Both groups were balanced for age , sex , performance status , tumor length/location , histology , grading , T-stage/N-stage , chemotherapy , treatment schedule , and hemoglobin before RT . Median change of hemoglobin was + 0.3 g/dL/wk with epoetin alfa and -0.5 g/dL/wk without epoetin alfa . At least 60 % of hemoglobin levels were 12 to 14 g/dL in 64 % and 17 % of the patients , respectively ( p epoetin alfa had better OS ( 32 % vs. 8 % at 2 years , p = 0.009 ) and LC ( 67 % vs. 15 % at 2 years , p = 0.001 ) . MFS was not significantly different ( 42 % vs. 18 % at 2 years , p = 0.09 ) . CONCLUSIONS The findings suggest that epoetin alfa when used to maintain the hemoglobin levels at 12 to 14 g/dL can improve OS and LC of Stage III esophageal cancer patients",
"INTRODUCTION Pre-operative anaemia is well recognised in patients presenting with colorectal cancer ( CRC ) . While the benefits of long-term FeSO4 supplementation on Fe deficiency anaemia are well established , it is not known if short-course supplementation ( 2 - 3 weeks ) impacts significantly on pre-operative haemoglobin ( Hb ) levels . This study examines the impact of short-term , oral FeSO4 supplementation on patients undergoing surgery for CRC . PATIENTS AND METHODS All patients with CRC presenting to a single surgeon were included . At diagnosis , baseline Hb and blood film were checked on all patients who then received 200 mg tds of FeSO4 . Haemoglobin was rechecked pre-operatively and daily postoperatively . Patients requiring pre-operative blood transfusions were excluded from analysis . RESULTS Between 1 January 2004 and 31 December 2006 , 117 patients were identified , 14 of whom were excluded . Patients received a median of 39 days ' treatment with FeSO4 . Fifty-eight ( 56.3 % ) patients were anaemic at presentation gaining a mean of 1.73 g/dl ( P short-course FeSO4 supplementation . Right-sided tumours ( lower mean Hb at presentation ; P=0.008 ) responded more to FeSO4 when compared to left-sided tumours ( P in Hb was unrelated to pathological stage . The transfusion rate for all curative resections was 0.69 units/patient . For the historical cohort ( patients undergoing curative resection between 1 January 2001 and 31 December 2003 ) , the mean transfusion rate fell from 1.69 units/patient . CONCLUSIONS Routine short-course supplementation with iron offers improved pre-operative Hb prior to surgery in CRC , especially in right-sided lesions and those with presenting anaemia",
"INTRODUCTION The aim of this pilot study was to assess the effect of pre-operative inspiratory muscle training ( IMT ) on respiratory variables in patients undergoing major abdominal surgery . PATIENTS AND METHODS Respiratory muscle strength ( maximum inspiratory [ MIP ] and expiratory [ MEP ] mouth pressure ) and pulmonary functions were measured at least 2 weeks before surgery in 80 patients awaiting major abdominal surgery . Patients were then allocated r and omly to one of four groups ( Group A , control ; Group B , deep breathing exercises ; Group C , incentive spirometry ; Group D , specific IMT ) . Patients in groups B , C and D were asked to train twice daily , each session lasting 15 min , for at least 2 weeks up to the day before surgery . Outcome measurements were made immediately pre-operatively and postoperatively . RESULTS In groups A , B and C , MIP did not increase from baseline to pre-operative assessment s. In group D , MIP increased from 51.5 cmH(2)O ( median ) pre-training to 68.5 cmH(2)O ( median ) post-training pre-operatively ( P MIP from baseline ( P postoperative MIP was seen in group D ( P = 0.36 ) . CONCLUSIONS Pre-operative specific IMT improves MIP pre-operatively and preserves it postoperatively . Further studies are required to establish if this is associated with reduced pulmonary complications",
"Cancer of the esophagus is often diagnosed at a late stage and is related to severe morbidity and a low 5-year survival rate . Previous studies have reported low health-related quality of life and high suicide rates for these patients . The occurrence of psychiatric morbidity and thus the potential need for psychological support may vary over time after diagnosis . This has not been adequately studied in patients with newly diagnosed cancer of the esophagus or gastro-esophageal junction . The present study therefore aim ed to prospect ively evaluate the prevalence of psychiatric morbidity in 94 consecutive patients ( median age 66 , range 45 - 88 years ) with all stages of disease . Psychiatric morbidity was evaluated with the Hospital Anxiety and Depression Scale ( HADS ) question naire at inclusion and 1 , 2 , 3 , 6 and 12 months later . At inclusion , 42 % of the patients had HADS scores indicating possible or probable anxiety disorder and /or depression . At all follow-ups except at 3 months , proportions of patients with possible/probable anxiety disorder were significantly lower than at inclusion . Among patients with a duration of tumor-specific symptoms exceeding 6 months pre-diagnosis , larger proportions of patients with a possible/probable anxiety disorder were found at the 1- and 6-month follow ups . The prevalence of possible/probable depression was greater among patients treated with a palliative intent than among those with a curative intent at inclusion . Patients who died during the study period scored worse for depression compared to the survivors . Apart from this , the proportion of patients with possible/probable psychiatric morbidity ( anxiety and /or depression ) was relatively stable over time and was unrelated to patient characteristics or clinical background , including the treatment regime . In conclusion , psychiatric morbidity is common among esophageal cancer patients , both at inclusion and over time , regardless of the cancer therapy given . The findings stress the importance of monitoring the patients ' mental health and of offering adequate psychological care when needed",
"BACKGROUND In a previous study we showed that many patients with esophagogastric adenocarcinoma experience anemia during neoadjuvant chemotherapy . We now investigated the role of erythropoietin in managing anemia during neoadjuvant chemotherapy . METHODS Patients with esophagogastric adenocarcinoma who experienced anemia ( hemoglobin neoadjuvant treatment received erythropoietin 10,000 IE subcutaneously three times a week . Primary outcomes were the response to erythropoietin , safety , the need for allogeneic red blood cell transfusion , and the rate of postoperative complications . RESULTS Between April 2003 and December 2004 , 24 patients ( median age , 62 years ) were enrolled . The mean hemoglobin level before chemotherapy was 12.5 g/dL and the mean hemoglobin level before patients received erythropoietin was 11.5 g/dL. One year after involvement in the trial , 4 of 17 analyzable patients were still anemic ( hemoglobin level erythropoietin , and 16 ( 73 % ) responded . We could observe a significant increase in hemoglobin concentrations under therapy with erythropoietin to 12.6 g/dL ( p allogeneic transfusions ; the rate of postoperative complications was 16 % . There were no erythropoietin-related adverse events . CONCLUSIONS Treatment with erythropoietin is effective and well tolerated in patients with esophagogastric adenocarcinoma who experience anemia during neoadjuvant chemotherapy",
"Objective : The aim of this trial was to investigate whether a routine of allowing normal food at will increases morbidity after major upper gastrointestinal ( GI ) surgery . Summary Background Data : Nil-by-mouth with enteral tube feeding is widely practice d for several days after major upper GI surgery . After other abdominal operations , normal food at will has been shown to be safe and to improve gut function . Methods : Patients were r and omly assigned to a routine of nil-by-mouth and enteral tube feeding by needle-catheter jejunostomy ( ETF group ) or normal food at will from the first day after major upper GI surgery . Primary end point was rate of major complications and death . Secondary outcomes were minor complications and adverse events , bowel function , and length of stay . All patients were invited to a follow-up at 8 weeks after discharge from the hospital . Results : Four hundred fifty-three patients who underwent major open upper GI surgery in 5 centers were enrolled between 2001 and 2006 . Four hundred forty-seven patients were correctly r and omized . Of 227 patients 76 ( 33.5 % ) had major complications in the ETF group compared with 62 ( 28.2 % ) of 220 patients allowed normal food at will ( P = 0.26 , 95 % CI for the difference in rate from −3.3 to 13.9 ) . In the ETF group , 36 ( 15.9 % ) patients were reoperated compared with 29 ( 13.2 % ) in the group allowed normal food at will ( P = 0.50 ) and 30-day mortality was 10 ( 4.4 % ) of 227 and 11 ( 5.0 % ) of 220 patients , respectively ( P = 0.83 ) . Time to resumed bowel function was significantly in favor of allowing normal food at will ( P = 0.01 ) , as were the total number of major complications , length of stay , and rate of postdischarge complications . Conclusions : Allowing patients to eat normal food at will from the first day after major upper GI surgery does not increase morbidity compared with traditional care with nil-by-mouth and enteral feeding",
"BACKGROUND We investigated whether supplementation of enteral nutrition ( EN ) with omega-3 polyunsaturated acids ( PUFAs ) affected platelet aggregation , coagulation activity , and inflammatory response in the early stages after esophageal cancer surgery . METHODS Twenty-eight patients with esophageal cancer who underwent the same surgical procedure were selected for this study . All patients received EN , which was started immediately after the operation and was increased to a maximum volume of 1500 ml/day by the third postoperative day ( POD ) . Eleven patients received a conventional EN formula ( Ensure Liquid ) , while the remaining 17 patients received a different formula rich in omega-3 PUFAs ( Racol [ RAC ] ) . Several markers of coagulation and fibrinolysis were determined in POD 2 , while the concentrations of interleukin (IL)-6 , IL-8 , 6-keto-PGF1alpha and thromboxane B2 were determined on PODs 1 , 3 , and 5 . RESULTS A total of 27 patients completed the study , 11 in the Ensure Liquid group and 16 in the RAC group . Administration of RAC significantly inhibited the postoperative decrease in platelet count . The level of D-dimer was attenuated significantly in the RAC group . Plasma IL-8 levels were decreased significantly in the RAC group on PODs 1 and 3 . The anti-inflammatory effects of omega-3 PUFAs were confirmed by the clinical findings of lower body temperature . The plasma concentration of 6-keto-PFG1alpha also tended to decrease in the RAC group with a significant difference on POD 5 . CONCLUSIONS Early EN with a large amount of omega-3 PUFAs in reduced platelet aggregation , coagulation activity , and cytokine production . All these effects would be expected to be beneficial in patients following esophageal cancer surgery . The clinical significance of the changes in eicosanoid production remains to be established",
"Background and Objectives : It is common practice to catheterize the bladder in the presence of epidural analgesia and to leave the bladder catheter in situ to avoid postoperative urinary retention . However , bladder catheterization carries the risk for urinary tract infection ( UTI ) . The objective of this r and omized control trial was to assess whether the incidence of UTI will differ among patients receiving st and ard care and patients who have the bladder catheterization discontinued on the morning after surgery with the epidural still functioning . Methods : Patients at low risk for postoperative urinary retention , scheduled for thoracic and abdominal surgery and receiving continuous thoracic epidural analgesia , were r and omized on the morning after surgery to 2 groups : in the early removal group ( n = 105 ) , the bladder catheter was removed on the same morning after surgery , whereas in the st and ard group ( SG ) ( n = 110 ) , the bladder catheter was removed when epidural analgesia was discontinued ( 3 - 5 days ) . Urinary bladder volume was assessed by ultrasound . Primary and secondary outcomes were the incidence of UTI and rate of recatheterization . Results : Two hundred fifteen patients were r and omized . There were 17 UTI cases in total , with 15 ( 14 % ) in the SG and 2 ( 2 % ) in the early removal group ( P = 0.004 ) . The incidence of recatheterizations was not different between the 2 groups ( P = 0.09 ) and did not correlate with the site of epidural insertion . When matched for the types of surgery , the duration of hospital stay was longer in the patients who contracted UTI ( P = 0.004 ) . There were more patients older than 65 years in the SG . Conclusions : Leaving the bladder catheter as long as the epidural analgesia is maintained results in a higher incidence of UTI and prolonged hospital stay . Removal of the bladder catheter on the morning after surgery does not lead to higher rate of catheterizations",
"Background Morphine and ketamine may prevent central sensitization during surgery and result in preemptive analgesia . The reliability of preemptive analgesia , however , is controversial . Methods Gastrectomy patients were given preemptive analgesia consisting of epidural morphine , intravenous low-dose ketamine , and combinations of these in a r and omized , double-blind manner . Postsurgical pain intensity was rated by a visual analog scale , a categoric pain evaluation , and cumulative morphine consumption . Results Preemptive analgesia by epidural morphine and by intravenous low-dose ketamine were significantly effective but not definitive . With epidural morphine , a significant reduction in visual analog scale scores at rest was observed at 24 and 48 h , and morphine consumption was significantly lower at 6 and 12 h , compared with control values . With intravenous ketamine , visual analog scale scores at rest and morphine consumption were significantly lower at 6 , 12 , 24 , and 48 h than those in control subjects . The combination of epidural morphine and intravenous ketamine provided definitive preemptive analgesia : Visual analog scale scores at rest and morphine consumption were significantly the lowest at 6 , 12 , 24 , and 48 h , and the visual analog scale score during movement and the categoric pain score also were significantly the lowest among the groups . Conclusion The results suggest that for definitive preemptive analgesia , blockade of opioid and N-methyl-d-aspartate receptors is necessary for upper abdominal surgery such as gastrectomy ; singly , either treatment provided significant , but not definitive , postsurgical pain relief . Epidural morphine may affect the spinal cord segmentally , whereas intravenous ketamine may block brain stem sensitization via the vagus nerve during upper abdominal surgery",
"PURPOSE Enhanced recovery pathways ( ERP ) decrease morbidity and duration of stay after colorectal surgery . There is little information about their role in complex procedures , such as esophagectomy . The purpose of this study was to determine the impact of an ERP on duration of stay , complications , and readmissions after esophagectomy . METHODS Patients undergoing esophagectomy for cancer or high- grade dysplasia from June 2009 to December 2011 were identified from a prospect ively maintained data base . Beginning in June 2010 , all patients were enrolled in a 7-day multidisciplinary ERP including written patient education with daily treatment plan , indications for intensive care admission , early structured mobilization , and diet and drain management . Short-term ( 30-day ) outcomes were compared for patients undergoing esophagectomy pre- and post-pathway . Data are expressed as median values [ interquartile range ] . RESULTS We identified 106 patients ; 47 underwent esophagectomy before ERP implementation and 59 after . Patients were similar with respect to age , gender , diagnosis , and operative time . Hospital stay was shorter in the ERP group ( 8 [ 7 - 17 ] vs 10 [ 9 - 17 ] days ; P = .01 ) . There were no differences in rates of complications ( 59 % vs 62 % ) or readmissions ( 6 % vs 5 % ) . CONCLUSION Implementation of a multidisciplinary ERP for esophagectomy was associated with decreased duration of stay , without an increase in complications or readmissions",
"Background Protocol s for enhanced recovery provide comprehensive and evidence -based guidelines for best perioperative care . Protocol implementation may reduce complication rates and enhance functional recovery and , as a result of this , also reduce length-of-stay in hospital . There is no comprehensive framework available for pancreaticoduodenectomy . Methods An international working group constructed within the Enhanced Recovery After Surgery ( ERAS ® ) Society constructed a comprehensive and evidence -based framework for best perioperative care for pancreaticoduodenectomy patients . Data were retrieved from st and ard data bases and personal archives . Evidence and recommendations were classified according to the GRADE system and reached through consensus in the group . The quality of evidence was rated “ high ” , “ moderate ” , “ low ” or “ very low ” . Recommendations were grade d as “ strong ” or “ weak ” . Results Comprehensive guidelines are presented . Available evidence is summarised and recommendations given for 27 care items . The quality of evidence varies substantially and further research is needed for many issues to improve the strength of evidence and grade of recommendations . Conclusions The present evidence -based guidelines provide the necessary platform upon which to base a unified protocol for perioperative care for pancreaticoduodenectomy . A unified protocol allows for comparison between centres and across national borders . It facilitates multi-institutional prospect i ve cohort registries and adequately powered r and omised trials"
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Background We summarize the existing evidence on the potential benefit of oral anticoagulation ( OAC ) in intracerebral hemorrhage ( ICH ) survivors with nonvalvular atrial fibrillation ( NVAF ) . Methods Systematic review of the literature to address the following issues : ( 1 ) prevalence of NVAF in ICH survivors , ( 2 ) current prescription of OAC , ( 3 ) factors associated with resumption of OAC , ( 4 ) risk of ischemic stroke ( IS ) and recurrent ICH , and ( 5 ) ideal timing for restarting OAC in ICH survivors with NVAF . Results After screening 547 articles , 26 were included in the review . Only 3 focused specifically on patients with ICH as primary event , NVAF as indication for OAC , and recurrent ICH and IS as primary endpoints . In addition , 19 letters to the editor/ review s/editorials/experts ' surveys/experts ' opinion were used for discussion purpose s. Conclusions NVAF is highly prevalent among ICH survivors . The risks of IS , recurrent ICH , and mortality are heightened in this group . Most published data show a net benefit in terms of IS prevention and mortality when anticoagulation is restarted . However , those studies are observational and mostly retrospective , therefore selection bias may play a major role in the results observed in these cohorts . Only r and omized controlled trials , either pragmatic or explanatory , can provide more conclusive answers for this important clinical question
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"Background There is a marked lack of evidence on the optimal prevention of ischaemic stroke and other thromboembolic events in patients with non-valvular atrial fibrillation and a recent intracerebral haemorrhage during treatment with oral anticoagulation . These patients are currently treated with oral anticoagulants , antiplatelet drugs , or no antithrombotic treatment , depending on personal and institutional preferences . Compared with warfarin , the direct oral anticoagulant apixaban reduces the risk of stroke or systemic embolism , intracranial haemorrhage , and case fatality in patients with atrial fibrillation . Compared with aspirin , apixaban reduces the risk of stroke or systemic embolism in patients with atrial fibrillation , and has a similar risk of intracerebral haemorrhage . Novel oral anticoagulants have not been evaluated in patients with atrial fibrillation and a recent intracerebral haemorrhage . To inform a phase III trial , the phase II Apixaban versus Antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intraCerebral HaEmorrhage in patients with Atrial Fibrillation ( APACHE-AF ) trial aims to obtain estimates of the rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a recent anticoagulation-associated intracerebral haemorrhage treated with apixaban and in those in whom oral anticoagulation is avoided . Methods / Design APACHE-AF is a phase II , multicentre , open-label , parallel-group , r and omised clinical trial with masked outcome assessment . One hundred adults with a history of atrial fibrillation and a recent intracerebral haemorrhage during treatment with anticoagulation in whom clinical equipoise exists on the optimal stroke prevention strategy will be enrolled in 14 hospitals in The Netherl and s . These patients will be r and omly assigned in a 1:1 ratio to either apixaban or to avoiding oral anticoagulation . Patients in the control group may be treated with antiplatelet drugs at the discretion of the treating physician . The primary outcome is the composite of vascular death or non-fatal stroke during follow-up . We aim to include 100 patients in 2.5 years . All patients will be followed-up for the duration of the study , but at least for 1 year . Recruitment commenced in September 2014 and is ongoing . This trial is funded by the Dutch Heart Foundation ( 2012 T077 ) and ZonMW (015008048).Trial registration NTR4526 ( 16 April 2014 )",
"BACKGROUND Percutaneous left atrial appendage closure ( LAAC ) may be considered in patients with atrial fibrillation and contraindication for long-term anticoagulation . This study aim ed to assess the safety and efficacy of LAAC followed by single antiplatelet therapy in patients with atrial fibrillation and previous spontaneous intracerebral hemorrhage ( ICH ) . METHODS In this explorative , prospect i ve , single-center study , consecutive patients who underwent LAAC because of previous spontaneous ICH over a period of 4 years were analyzed . Risks of ischemic strokes and hemorrhagic complications were estimated using the CHA2DS2-VASc and HAS-BLED scores , respectively . Single antiplatelet therapy was given for at least 6 months post implantation . Clinical follow-up included cardiological evaluations at 1 , 3 , 6 , and 12 months , and neurological evaluations at 3 and 12 months . RESULTS A total of 46 patients underwent LAAC with a mean follow-up of 12 ± 7 months . The observed annual rate of ischemic stroke was 4.35 % compared with an expected rate of 7.23 % according to the mean risk of the population based on CHA2DS2-VASc score , which translated into a 40 % risk reduction . The observed annual rate of major bleeding was 4.35 % compared with an expected rate of 8.05 % according to the mean risk of the population based on HAS-BLED score , which translated into a 46 % risk reduction . CONCLUSIONS LAAC followed by single antiplatelet therapy is feasible as an alternative to oral anticoagulation in high-risk patients with previous ICH , with an acceptable periprocedural risk . Longer follow-up in a larger number of patients will be needed to establish the effectiveness of LAAC relative to direct oral anticoagulants",
"Background : For patients who survive intracerebral haemorrhage ( ICH ) during treatment with oral anticoagulation ( OAC ) , the balance between the benefits and risks of restarting OAC is unclear . The decision to restart OAC or to start antiplatelet therapy in these patients therefore poses a dilemma for all physicians involved . We assessed the long-term outcome of patients who did or did not restart antithrombotic therapy after OAC-associated ICH . Methods : We conducted a retrospective follow-up study of all patients discharged from our institution after OAC-associated ICH over a 10-year period . Data on the use of OAC or platelet inhibitors and the occurrence of vascular events during follow-up were assessed through question naires and patient files . The primary outcome was recurrent fatal or non-fatal stroke . Secondary outcomes were the occurrence of other haemorrhagic , thrombotic or thromboembolic events . With patients without antithrombotic treatment as reference , we calculated incidence ratios with corresponding 95 % confidence intervals ( CI ) for treatment with OAC and for treatment with antiplatelet therapy . Results : We included 38 patients , of whom 21 ( 55 % ) died during a mean follow-up of 3.5 years . The medication regime changed frequently during follow-up , illustrated by the fact that two thirds of the patients who had resumed OAC within 2 months of ICH terminated this at later points in time . Two recurrent strokes occurred during 35.4 patient-years without antithrombotic medication , 7 during 63.8 patient-years on antiplatelet medication ( incidence ratio 1.9 ; 95 % CI , 0.4 - 9.4 ) , and 3 during 19.5 patient-years on OAC ( incidence ratio 2.7 ; 95 % CI , 0.5 - 16.3 ) . There was only 1 recurrent ICH , which occurred during treatment with OAC . Conclusion : In this observational study , no significant difference in the primary outcome measure was found between the treatment groups , but there was a tendency towards a higher long-term risk of any stroke in patients who resumed OAC or started antiplatelet therapy . However , based on these results it is difficult to draw any concrete conclusions or make any strong recommendations . A r and omized trial to assess the optimal long-term strategy after OAC-related ICH is warranted . Based on the point estimates of our study , such a trial should involve at least 300 patient-years of follow-up",
"BACKGROUND While warfarin-related intracranial hemorrhage ( ICH ) occurs in 0.25%-1.1 % patients per year , little is known about the practice and outcomes of anticoagulant reinitiation . METHODS We studied a cohort of consecutive patients with warfarin-related ICH ( intracerebral or subarachnoid ) admitted to 13 stroke centres in the Registry of the Canadian Stroke Network between July 2003 and March 2008 . We examined patterns of warfarin reinitiation and variables associated with 30-day and 1-year outcomes . RESULTS Among the 284 patients studied ( mean age 74 ± 12 years ) , warfarin was restarted in-hospital in 91 patients ( 32 % ) . Factors associated with restarting warfarin were lower stroke severity ( adjusted odds ratio [ aOR ] 2.07 , 95 % confidence interval [ CI ] ; 1.20 - 3.57 , P = 0.009 ) or presence of valve prosthesis ( aOR 3.07 , 95 % CI ; 1.29 - 7.27 , P = 0.011 ) . Mortality rates were not higher in those who restarted warfarin in-hospital : 31.9 % vs 54.4 % ( 30-day , P and bleeding was not increased . Multivariable predictors of mortality included initial international normalized ratio > 3.0 ( aOR , 3.28 [ 30-day , P ) , greater stroke severity ( aOR , 6.04 [ 30-day ] and 4.22 [ 1-year ] ; both P ) , and intraventricular hemorrhage ( aOR , 2.19 [ 30-day ; P = 0.03 ] and 2.04 [ 1-year ; P = 0.04 ] ) . In selected patients who reinitiated warfarin , there was no increase in 30-day ( aOR , 0.49 ; P = 0.03 ) or 1-year mortality ( aOR , 0.79 ; P = 0.43 ) . CONCLUSIONS In selected patients at high thrombosis risk , reinitiation of warfarin after ICH did not confer increased mortality or bleeding events",
"BACKGROUND Warfarin sodium is highly effective for prevention of embolic stroke , particularly in nonvalvular atrial fibrillation , but its expected benefit can be offset by risk of intracerebral hemorrhage ( ICH ) . We studied the determinants of ICH outcome to quantify the independent effect of warfarin . METHODS Consecutive patients with supratentorial ICH treated in a tertiary care hospital with a neurointensive care unit were prospect ively identified during a 7-year period , and data on hemorrhage location , clinical characteristics , and warfarin use were collected . Independent predictors of 3-month mortality were determined using multiple logistic regression analysis . RESULTS Of 435 consecutive patients aged 55 years or older , 102 ( 23.4 % ) were taking warfarin at the time of ICH . Three-month mortality was 25.8 % for those not taking warfarin and 52.0 % for those taking warfarin . Independent predictors of death were warfarin use ( odds ratio [ OR ] , 2.2 ; 95 % confidence interval [ CI ] , 1.3 - 3.8 ) , age 70 years or older ( OR , 2.4 ; 95 % CI , 1.4 - 4.0 ) , and presence of diabetes mellitus ( OR , 1.8 ; 95 % CI , 1.0 - 3.3 ) . Although 68.0 % of all warfarin-related hemorrhages occurred at an international normalized ratio ( INR ) of 3.0 or less , increasing degrees of anticoagulation were strongly associated with increasing risk of death compared with no warfarin use . CONCLUSIONS Patients taking warfarin had a doubling in the rate of intracerebral hemorrhage mortality in a dose-dependent manner . The data suggest that careful control of the INR , already known to limit the risk of warfarin-related ICH , may also limit its severity",
"OBJECTIVES The purpose of this study was to assess the safety and efficacy of left atrial appendage ( LAA ) closure in nonvalvular atrial fibrillation ( AF ) patients ineligible for warfarin therapy . BACKGROUND The PROTECT AF ( Watchman Left Atrial Appendage System for Embolic Protection in Patients With Atrial Fibrillation ) trial demonstrated that LAA closure with the Watchman device ( Boston Scientific , Natick , Massachusetts ) was noninferior to warfarin therapy . However , the PROTECT AF trial only included patients who were c and i date s for warfarin , and even patients r and omly assigned to the LAA closure arm received concomitant warfarin for 6 weeks after Watchman implantation . METHODS A multicenter , prospect i ve , nonr and omized study was conducted of LAA closure with the Watchman device in 150 patients with nonvalvular AF and CHADS₂ ( congestive heart failure , hypertension , age ≥75 years , diabetes mellitus , and prior stroke or transient ischemic attack ) score ≥1 , who were considered ineligible for warfarin . The primary efficacy endpoint was the combined events of ischemic stroke , hemorrhagic stroke , systemic embolism , and cardiovascular/unexplained death . RESULTS The mean CHADS₂ score and CHA₂DS₂-VASc ( CHADS₂ score plus 2 points for age ≥75 years and 1 point for vascular disease , age 65 to 74 years , or female sex ) score were 2.8 ± 1.2 and 4.4 ± 1.7 , respectively . History of hemorrhagic/bleeding tendencies ( 93 % ) was the most common reason for warfarin in eligibility . Mean duration of follow-up was 14.4 ± 8.6 months . Serious procedure- or device-related safety events occurred in 8.7 % of patients ( 13 of 150 patients ) . All-cause stroke or systemic embolism occurred in 4 patients ( 2.3 % per year ) : ischemic stroke in 3 patients ( 1.7 % per year ) and hemorrhagic stroke in 1 patient ( 0.6 % per year ) . This ischemic stroke rate was less than that expected ( 7.3 % per year ) based on the CHADS₂ scores of the patient cohort . CONCLUSIONS LAA closure with the Watchman device can be safely performed without a warfarin transition , and is a reasonable alternative to consider for patients at high risk for stroke but with contraindications to systemic oral anticoagulation . ( ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology [ ASAP ] ; NCT00851578 )",
"OBJECTIVE To search out independent prognostic factors , including preictal variables for outcome of spontaneous intracerebral hemorrhage . DESIGN Prospect i ve follow-up study . PATIENTS One hundred fifty-six consecutive patients ( 96 men and 60 women ) aged 16 to 60 years admitted as emergencies after bleeding . MAIN OUTCOME MEASURES Potential risk factors ( baseline characteristics , health habits , and clinical variables ) for death and impaired outcome were studied prospect ively up to 1 year after hemorrhage . RESULTS One year after hemorrhage , 64 patients ( 41 % ) were independent and 34 patients ( 22 % ) were dependent in the activities of daily living ; 58 patients ( 37 % ) had died . Risk of death was predicted , after adjustment for sex , age , hypertension , and body mass index , by clinical condition at admission according to the Glasgow Coma Scale ( P Risk of poor outcome ( dependent state or death ) was predicted , after adjustment for sex , hypertension , body mass index , cigarette smoking , presence of intraventricular hemorrhage , and surgery , significantly by the Glasgow Coma Scale ( P presence of subcortical hematoma ( OR , 0.04 ; 95 % CI , 0.01 to 0.27 ; P volume of hematoma ( P = .03 ) ; age ( P = .004 ) ; amount of alcohol consumed within 1 week before hemorrhage ( P = .03 ) ; and presence of cerebellar hematoma ( OR , 0.13 ; 95 % CI , 0.02 to 0.95 ; P = .04 ) . Significant independent predictors of impaired outcome ( assessed with the Glasgow Outcome Scale ) were the Glasgow Coma Scale ( P presence of subcortical hematoma ( OR , 0.26 ; 95 % CI , 0.10 to 0.67 ; P = .006 ) ; alcohol intake within 1 week ( P = .002 ) ; and presence of cerebellar ( OR , 0.16 ; 95 % CI , 0.04 to 0.60 ; P = .008 ) , intraventricular ( OR , 2.74 ; 95 % CI , 1.19 to 6.28 ; P = .02 ) , or cau date hemorrhage ( OR , 0.13 ; 95 % CI , 0.02 to 0.77 ; P = .03 ) . The mean erythrocyte corpuscular volume was directly associated with an impaired outcome ( P < .05 ) . CONCLUSION In addition to severity and location of the hemorrhage , the age of the patient and the amount of alcohol consumed within 1 week seem to be independent determinants of outcome after intracerebral hemorrhage",
"Background : Survivors of intracerebral hemorrhage are at risk for recurrent intracerebral hemorrhage and ischemic cardiovascular and cerebrovascular disease . Objective : To determine whether antiplatelet therapy increases the risk of recurrent intracerebral hemorrhage . Methods : The authors review ed data from consecutive survivors of primary intracerebral hemorrhage enrolled in a single-center prospect i ve cohort study . Survivors were followed by telephone interview ; recurrent intracerebral hemorrhage and post – index antiplatelet agent use and duration were recorded . Cox proportional hazards models was used with antiplatelet agent exposure as a time-dependent variable to assess the effect of antiplatelet agent use on recurrent intracerebral hemorrhage , stratified by lobar and deep hemispheric location . Results : Recurrent intracerebral hemorrhage was more common in survivors of lobar hemorrhage compared with survivors of deep hemorrhage ( cumulative 2-year rate 22 % vs 4 % ; p = 0.007 ) . Antiplatelet agents were prescribed in 22 % of intracerebral hemorrhage survivors ( 27/127 lobar , 19/80 deep hemispheric ) , most commonly for prevention of ischemic heart disease . Antiplatelet agent use was not associated with intracerebral hemorrhage recurrence in survivors of either lobar hemorrhage ( hazard ratio [ HR ] 0.8 , 95 % CI 0.3 to 2.3 , p = 0.73 ) or of deep hemorrhage ( HR 1.2 , 95 % CI 0.1 to 14.3 , p = 0.88 ) . Conclusion : Antiplatelet agent use is relatively common following intracerebral hemorrhage but did not appear to be associated with a large increased risk of intracerebral hemorrhage recurrence in this observational study",
"BACKGROUND Recurrent lobar intracerebral hemorrhage is the hallmark of cerebral amyloid angiopathy . The factors that predispose patients to early recurrence of lobar hemorrhage are unknown . One c and i date is the apolipoprotein E gene , since both the epsilon2 and the epsilon4 alleles of apolipoprotein E appear to be associated with the severity of amyloid angiopathy . METHODS We performed a prospect i ve , longitudinal study of consecutive elderly patients who survived a lobar intracerebral hemorrhage . The patients were followed for recurrent hemorrhagic stroke by interviews at six-month intervals and review s of medical records and computed tomographic scans . RESULTS Nineteen of 71 enrolled patients had recurrent hemorrhages during a mean follow-up period of 23.9+/-14.8 months , yielding a 2-year cumulative rate of recurrence of 21 percent . The apolipoprotein E genotype was significantly associated with the risk of recurrence . Carriers of the epsilon2 or epsilon4 allele had a two-year rate of recurrence of 28 percent , as compared with only 10 percent for patients with the common apolipoprotein E epsilon3/epsilon3 genotype ( risk ratio , 3.8 ; 95 percent confidence interval , 1.2 to 11.6 ; P=0.01 ) . Early recurrence occurred in eight patients , four of whom had the uncommon epsilon2/epsilon4 genotype . Also at increased risk for recurrence were patients with a history of hemorrhagic stroke before entry into the study ( two-year recurrence , 61 percent ; risk ratio , 6.4 ; 95 percent confidence interval , 2.2 to 18.5 ; P apolipoprotein E genotype can identify patients with lobar intracerebral hemorrhage who are at highest risk for early recurrence . This finding makes possible both the provision of prognostic information to patients with lobar hemorrhage and a method of targeting and assessing potential strategies for prevention",
"Background and Purpose — Whether intracerebral hemorrhage ( ICH ) survivors should restart antithrombotic drugs is unknown . We analyzed the frequency of restarting antithrombotic drugs in ICH survivors who had taken prophylactic antithrombotic drugs in atrial fibrillation or after thromboembolic disease in 5 cohorts and explored factors associated with doing so . Methods — We compared the characteristics and proportions of patients taking antithrombotic drugs at ICH onset and discharge in 4 hospital-based cohorts ( Lille , France , n=542 ; Utrecht , The Netherl and s , n=389 ; multicenter Clinical Relevance of Microbleeds in Stroke-2 ( CROMIS-2 ) ICH , United Kingdom , n=667 ; and Amsterdam , The Netherl and s , n=403 ) and 1 community-based study ( Lothian , Scotl and , n=137 ) , using bivariate analyses . We sought characteristics associated with restarting using bivariate and multivariable logistic regression analyses . Results — A total of 942 ( 44 % ) patients with ICH took antithrombotic drugs at hospital admission ( no difference between cohorts ) . Antithrombotic drugs were restarted in 96 ( 20 % ) of the 469 survivors who had taken antithrombotic drugs for secondary prevention or atrial fibrillation , but this proportion differed when stratified by the cohort of origin ( Lille , 18 % ; Utrecht , 45 % ; Lothian , 15 % ; CROMIS-2 ICH , 11 % ; Amsterdam , 20 % ; P of antithrombotic drug pre-ICH ( 14 % in patients with previous antiplatelet drugs versus 26 % in patients with previous vitamin K antagonists and 41 % in patients with both drugs ; P antithrombotic drugs . Conclusions — The variation in clinical practice and lack of consistent associations with restarting antithrombotic drugs after ICH reflect current knowledge and support the need for r and omized controlled trials to resolve this dilemma",
"SUMMARY BACKGROUND Patients who present with central nervous system ( CNS ) hemorrhage while on anticoagulation ( AC ) for thromboembolic ( TE ) risk factors are a challenge to manage . OBJECTIVE We sought to inform decisions surrounding the timing and intensity of AC resumption by performing a systematic review . METHODS Three review ers screened publications from Medline and EMBASE and extracted data . Hemorrhagic and TE adverse events that occurred subsequent to the index hemorrhage were recorded , as was their timing relative to presentation and covariates that might influence their occurrence . RESULTS Data were extracted from 63 publications detailing 492 patients ; 7.7 % of patients experienced hemorrhagic complications and 6.1 % experienced TE complications . Hemorrhagic complications were more common within 72 h of presentation while TE complications were more common thereafter . Patients restarted on AC after 72 h were significantly more likely to have a TE complication ( P = 0.006 ) and those restarted before 72 h were more likely to hemorrhage ( P = 0.0727 ) . Factors associated with re-hemorrhage included younger age , traumatic cause , subdural hematomas and failure to reverse AC . TE complications were more common in younger patients and those with spinal hemorrhage , multiple hemorrhages , and non-traumatic causes of the index hemorrhage . Re-initiation of AC at a lower intensity also significantly increased the risk of TE complications . INTERPRETATION Our results suggest that it may be prudent to re-initiate AC earlier than previously thought , with the timing and intensity modified based on predictors of TE and hemorrhagic complications . These findings must be explored in a prospect i ve study because of limitations inherent to the analyzed studies",
"AIMS The impact of some risk factors for stroke and bleeding , and the value of stroke and bleeding risk scores , in atrial fibrillation ( AF ) , has been debated , as clinical trial cohorts have not adequately tested these . Our objective was to investigate risk factors for stroke and bleeding in AF , and application of the new CHA(2)DS(2)-VASc and HAS-BLED schemes for stroke and bleeding risk assessment s , respectively . METHODS AND RESULTS We used the Swedish Atrial Fibrillation cohort study , a nationwide cohort study of 182 678 subjects with a diagnosis of AF at any Swedish hospital between 1 July 2005 and 31 December 2008 , who were prospect ively followed for an average of 1.5 years ( 260 000 years at risk ) . With the use of the National Swedish Drug Registry , all patients who used an oral anticoagulant anytime during follow-up were identified . Most of the analyses were made on a subset of 90 490 patients who never used anticoagulants . Risk factors for stroke , the composite thromboembolism endpoint ( stroke , TIA , or systemic embolism ) , and bleeding , and the performance of published stroke and bleeding risk stratification schemes were investigated . On multivariable analysis , significant associations were found between the following ' new ' risk factors and thromboembolic events ; peripheral artery disease [ hazard ratio ( HR ) 1.22 ( 95 % CI 1.12 - 1.32 ) ] , ' vascular disease ' [ HR 1.14 ( 1.06 - 1.23 ) ] , prior myocardial infa rct ion [ HR 1.09 ( 1.03 - 1.15 ) ] , and female gender [ HR 1.17 ( 1.11 - 1.22 ) ] . Previous embolic events , intracranial haemorrhage ( ICH ) , hypertension , diabetes , and renal failure were other independent predictors of the composite thromboembolism endpoint , while thyroid disease ( or hyperthyroidism ) was not an independent stroke risk factor . C-statistics for the composite thromboembolic endpoint with the CHADS(2 ) and CHA(2)DS(2)-VASc schemes were 0.66 ( 0.65 - 0.66 ) and 0.67 ( 0.67 - 0.68 ) , respectively . On multivariable analysis , age , prior ischaemic stroke or thromboembolism , prior major bleeding events , and hypertension were significant predictors of ICH and major bleeding . Heart failure , diabetes , renal failure , liver disease , anaemia or platelet/coagulation defect , alcohol abuse , and cancer were other significant predictors for major bleeding , but not ICH . The ability for predicting ICH and major bleeding with both bleeding risk schemes ( HEMORR(2)HAGES , HAS-BLED ) were similar , with c-statistics of ~0.6 . CONCLUSION Several independent risk factors ( prior ICH , myocardial infa rct ion , vascular disease , and renal failure ) predict ischaemic stroke and /or the composite thromboembolism endpoint in AF , but thyroid disease ( or hyperthyroidism ) was not an independent risk factor for stroke . There is a better performance for CHA(2)DS(2)-VASc over CHADS(2 ) schemes for the composite thromboembolism endpoint . While both tested bleeding risk schemes have similar predictive value , the HAS-BLED score has the advantage of simplicity",
"IMPORTANCE Although use of oral anticoagulants ( OACs ) is increasing , there is a substantial lack of data on how to treat OAC-associated intracerebral hemorrhage ( ICH ) . OBJECTIVE To assess the association of anticoagulation reversal and blood pressure ( BP ) with hematoma enlargement and the effects of OAC resumption . DESIGN , SETTING , AND PARTICIPANTS Retrospective cohort study at 19 German tertiary care centers ( 2006 - 2012 ) including 1176 individuals for analysis of long-term functional outcome , 853 for analysis of hematoma enlargement , and 719 for analysis of OAC resumption . EXPOSURES Reversal of anticoagulation during acute phase , systolic BP at 4 hours , and reinitiation of OAC for long-term treatment . MAIN OUTCOMES AND MEASURES Frequency of hematoma enlargement in relation to international normalized ratio ( INR ) and BP . Incidence analysis of ischemic and hemorrhagic events with or without OAC resumption . Factors associated with favorable ( modified Rankin Scale score , 0 - 3 ) vs unfavorable functional outcome . RESULTS Hemorrhage enlargement occurred in 307 of 853 patients ( 36.0 % ) . Reduced rates of hematoma enlargement were associated with reversal of INR levels INR reversal systolic BP of lower rates of hematoma enlargement ( 35/193 [ 18.1 % ] vs 220/498 [ 44.2 % ] not achieving these values ; OR , 0.28 ; 95 % CI , 0.19 - 0.42 ; P ) and lower rates of in-hospital mortality ( 26/193 [ 13.5 % ] vs 103/498 [ 20.7 % ] ; OR , 0.60 ; 95 % CI , 0.37 - 0.95 ; P = .03 ) . OAC was resumed in 172 of 719 survivors ( 23.9 % ) . OAC resumption showed fewer ischemic complications ( OAC : 9/172 [ 5.2 % ] vs no OAC : 82/547 [ 15.0 % ] ; P hemorrhagic complications ( OAC : 14/172 [ 8.1 % ] vs no OAC : 36/547 [ 6.6 % ] ; P = .48 ) . Propensity-matched survival analysis in patients with atrial fibrillation who restarted OAC showed a decreased HR of 0.258 ( 95 % CI , 0.125 - 0.534 ; P long-term mortality . Functional long-term outcome was unfavorable in 786 of 1083 patients ( 72.6 % ) . CONCLUSIONS AND RELEVANCE Among patients with OAC-associated ICH , reversal of INR hematoma enlargement , and resumption of OAC therapy was associated with lower risk of ischemic events . These findings require replication and assessment in prospect i ve studies . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01829581",
"Objective : To evaluate the safety and feasibility of percutaneous left atrial appendage occlusion ( LAAO ) in patients with atrial fibrillation ( AF ) and previous intracranial hemorrhage ( ICH ) . Methods : In an explorative , prospect i ve , single-center , observational study , LAAO was performed in patients with previous ICH and AF using the Amplatzer Cardiac Plug device . Risks of ischemic strokes and hemorrhagic complications were estimated using the CHA2DS2Vasc score and the HAS-BLED score . Before and 1 , 6 , 12 , and 24 months after the procedure , clinical status and complications were recorded . Major complications were predefined as periprocedural stroke , death , pericardial effusion , and device embolism . Results : LAAO was performed in 20 patients . Based on CHA2DS2Vasc score ( mean 4.5 ± 1.4 ) and HAS-BLED score ( mean 4.7 ± 1.0 ) , annual risks of stroke and hemorrhagic complications were 4.0%–6.7 % and 8.7%–12.5 % , respectively . No patient had a procedure-related complication . Minor postprocedural complications were observed in 4/20 patients ( 2 inguinal hematoma , 1 self-limiting asystole , and 1 thrombus formation on device ) . No ischemic or hemorrhagic stroke occurred during a mean follow-up of 13.6 ± 8.2 months . Conclusions : In this first study of LAAO in patients with previous ICH , LAAO appears feasible and safe . A larger , controlled trial is needed to assess the efficacy and safety of the procedure compared to other preventive measures . Classification of evidence : This study provides Class III evidence that in patients with a history of previous ICH and AF , percutaneous LAAO is safe and feasible"
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4117203a-06ff-11f0-808a-c43d1ab1c353
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Strengths assessment s focus on the individual 's talents , abilities , re sources , and strengths . No systematic review of strengths assessment s for use within mental health population s has been published . The aims of this study were to describe and evaluate strengths assessment s for use within mental health services . A systematic review identified 12 strengths assessment s ( 5 quantitative , 7 qualitative ) . The Strengths Assessment Worksheet ( SAW ) was the most widely utilized and evaluated qualitative assessment . Psychometric properties of the assessment s were assessed against set quality criteria . Data on psychometric properties were available for 4 measures . The Client Assessment of Strengths , Interests and Goals ( CASIG ) had the strongest psychometric evidence . The SAW and CASIG assessment s can be tentatively recommended within clinical practice , although the evidence for all strengths assessment s is currently limited . To describe the content of the strengths assessment , the items used to operationalize the concept of strengths in each assessment were extracted and themed . Twenty-four themes were identified and organized into 3 overarching categories : individual factors , environmental factors , and interpersonal factors . These categories form the basis of an empirically based definition of strengths that could be used as a conceptual foundation for new clinical assessment
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"Three methods of accounting for case manager effects in tests of the efficacy of mental health services are explored . These methods include ( a ) treating the case manager as a fixed factor , ( b ) treating the case manager as a r and om factor , and ( c ) examining service effects within the case manager . They are demonstrated with data from a nationally known case management program serving individuals with serious and persistent mental illness . Specifically , 3 conceptually distinct types of services provided or brokered by case managers are identified : habilitation-rehabilitation , community support , and traditional psychiatric services . The effectiveness of each in improving clients ' adjustment is then examined with multiple regression adjustment strategies and each of the 3 methods to account for case manager effects . The results provide strong support for effects attributable to case managers and some support for the efficacy of habilitation-rehabilitation and community support services beyond the effects of traditional psychiatric services",
"Positive psychology has flourished in the last 5 years . The authors review recent developments in the field , including books , meetings , courses , and conferences . They also discuss the newly created classification of character strengths and virtues , a positive complement to the various editions of the Diagnostic and Statistical Manual of Mental Disorders ( e. g. , American Psychiatric Association , 1994 ) , and present some cross-cultural findings that suggest a surprising ubiquity of strengths and virtues . Finally , the authors focus on psychological interventions that increase individual happiness . In a 6-group , r and om-assignment , placebo-controlled Internet study , the authors tested 5 purported happiness interventions and 1 plausible control exercise . They found that 3 of the interventions lastingly increased happiness and decreased depressive symptoms . Positive interventions can supplement traditional interventions that relieve suffering and may someday be the practical legacy of positive psychology",
"The purpose of this study was to determine theeffect on client outcomes produced by training casemanagers in a strengths model of case management . Outcomes of interest included client 's quality of life , vocation/education , residential living , hospitalization rate , hospital days , and symptoms . Italso compared the results obtained by the strengthsmodel with results of a generalist model . Case managers at the experimental site were trained in thestrengths model . Those at the control site received notraining . Data were collected at both sites prior totraining and three months later . Improvement in quality of life , symptoms , and vocational/educational outcomes were found in the experimental group . Quality of life and vocational/educational outcomes were betterin the experimental group than in the control group",
"We examined the effect of a case management intervention on drug treatment entry among injection drug users ( IDUs ) with and without comorbid antisocial personality disorder ( ASPD ) . Injection drug users attending the Baltimore Needle Exchange Program who sought and were granted referrals to opioid agonist treatment were r and omized to receive a strengths-based case management intervention or passive referral . Of 162 IDUs , 22.8 % met the DSM-IV criteria for ASPD . Compared to those without ASPD , IDUs with comorbid ASPD who spent 25 or more minutes with their case manager prior to their treatment entry date were 3.51 times more likely to enter treatment than those receiving less than 5 min , adjusting for intervention status , race , and treatment site ( 95 % confidence interval 1.04–11.89 ) . Providing case management services to IDUs with comorbid ASPD may facilitate treatment entry and reduce the negative consequences of drug abuse",
"BACKGROUND Routine use of st and ardised outcome measures is not universal . AIMS To evaluate the effectiveness of st and ardised outcome assessment . METHOD A r and omised controlled trial , involving 160 representative adult mental health patients and paired staff ( IS RCT N16971059 ) . The intervention group ( n=101 ) ( a ) completed monthly postal question naires assessing needs , quality of life , mental health problem severity and therapeutic alliance , and ( b ) received 3-monthly feedback . The control group ( n=59 ) received treatment as usual . RESULTS The intervention did not improve primary outcomes of patient-rated unmet need and of quality of life . Other subjective secondary outcome measures were also not improved . The intervention reduced psychiatric inpatient days ( 3.5 v.16.4 mean days , bootstrapped 95 % CI1.6 - 25.7 ) , and hence service use costs were 2586 UK pounds ( 95 % CI 102 - 5391 ) less for intervention-group patients . Net benefit analysis indicated that the intervention was cost-effective . CONCLUSIONS Routine use of outcome measures as implemented in this study did not improve subjective outcomes , but was associated with reduced psychiatric inpatient admissions",
"Conclusions The results of the present evaluation strongly support the essential need for formal case management in providing community support for individuals with serious mental illness . When compared to a control condition in which consumers received CMHC-wide support from therapists , day treatment personnel , and residential staff , the Strengths case management program was considerably more effective in achieving three specific community support goals : increasing consumer personal incomes , providing needed social support , and maintaining consumer physical health . Surprisingly , the case management program was also found to be effective in achieving a goal that is usually not targeted by case management : consumers in the case management group improved in therapist-assessed psychiatric symptomatology more than control group consumers . Since the control and the case management groups had comparable increases in attendance at primary therapy and medication management over the study period , we conclude that the case management program was directly responsible for the improvements in psychiatric symptoms within its caseload . Whether these improvements in mood and cognitive processing are attributable to co-occuring improvements in quality of life variables ( i.e. , social support or personal income ) or whether psychiatric improvement is more directly attributable to case managerin vivo counseling must be decided by future research .While formal Strengths case management appears to be efficacious as a community support— and perhaps as a psychiatric rehabilitation — intervention , a formal program of case management does not appear to be essential to CMHC preparation for Medicaid capitated financing . The Valley Mental Health case management program significantly increased consumers ' residential autonomy and attendance at primary therapy , but improvements on these two Medicaid-related variables were nearly matched within the control group through the efforts of other program staff . Taken as a whole , the study findings demonstrate that a formal case management program can work effectively in league with other CMHC programs to achieve specific managed care-related administrative goals , but that these delineated administrative goals can also be attained through a CMHC-wide mobilization of dedicated front-line staff",
"The Strengths model of team case management was assessed relative to an existing high quality psychosocial rehabilitation program that informally provided many services typical of case management ( e.g. , service linkage , monitoring , and consumer advocacy ) . The experimental evaluation triangulated consumer and family member responses with mental health professional reports and consumer records of hospitalization and crisis center contacts . An analysis of data from these four sources revealed that one year after full program implementation , consumers who received case management in conjunction with psychosocial rehabilitation functioned at a higher level of competency and experienced significantly lower psychiatric symptomatology than consumers who received only psychosocial rehabilitation . Implication s for the successful integration of case management into an existing community support program are discussed"
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41172076-06ff-11f0-808a-c43d1ab1c353
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CONTEXT : Early intensive behavioral and developmental interventions for young children with autism spectrum disorders ( ASDs ) may enhance developmental outcomes . OBJECTIVE : To systematic ally review evidence regarding such interventions for children aged 12 and younger with ASDs . METHODS : We search ed Medline , PsycINFO , and ERIC ( Education Re sources Information Center ) from 2000 to May 2010 . Two review ers independently assessed studies against predetermined inclusion /exclusion criteria . Two review ers independently extracted data regarding participant and intervention characteristics , assessment techniques , and outcomes and assigned overall quality and strength-of- evidence ratings using predetermined criteria . RESULTS : Thirty-four unique studies met inclusion criteria . Seventeen studies were case series ; 2 were r and omized controlled trials . We rated 1 study as good quality , 10 as fair quality , and 23 as poor quality . The strength of the evidence overall ranged from insufficient to low . Studies of University of California Los Angeles/Lovaas – based interventions and variants reported clinical ly significant gains in language and cognitive skills in some children , as did 1 r and omized controlled trial of an early intensive developmental intervention approach ( the Early Start Denver Model ) . Specific parent-training approaches yielded gains in short-term language function and some challenging behaviors . Data suggest that subgroups of children displayed more prominent gains across studies , but participant characteristics associated with greater gains are not well understood . CONCLUSIONS : Studies of Lovaas-based approaches and early intensive behavioral intervention variants and the Early Start Denver Model result ed in some improvements in cognitive performance , language skills , and adaptive behavior skills in some young children with ASDs , although the literature is limited by method ologic concerns
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"This study extends findings on the effects of intensive applied behavior analytic treatment for children with autism who began treatment at a mean age of 5.5 years . The behavioral treatment group ( n = 13 , 8 boys ) was compared to an eclectic treatment group ( n = 12 , 11 boys ) . Assignment to groups was made independently based on the availability of qualified supervisors . Both behavioral and eclectic treatment took place in public kindergartens and elementary schools for typically developing children . At a mean age of 8 years , 2 months , the behavioral treatment group showed larger increases in IQ and adaptive functioning than did the eclectic group . The behavioral treatment group also displayed fewer aberrant behaviors and social problems at follow-up . Results suggest that behavioral treatment was effective for children with autism in the study",
"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",
"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",
"This study was design ed to evaluate 1 year of intensive treatment for 4- to 7-year-old children with autism . An independent clinician assigned children to either behavioral treatment ( n = 13 ) or eclectic treatment ( n = 12 ) . Assignment was based on availability of personnel to supervise treatment and was not influenced by child characteristics or family preference . The two treatment groups received similar amounts of treatment ( M = 28.52 hours per week at the child ’s school ) . Children in the behavioral treatment group made significantly larger gains on st and ardized tests than did children in the eclectic treatment group . Results suggest that some 4- to 7-year-olds may make large gains with intensive behavioral treatment , that such treatment can be successfully implemented in school setting s , and that specific aspects of behavioral treatment ( not just its intensity ) may account for favorable outcomes",
" An intervention group ( n=23 ) of preschool children with autism was identified on the basis of parent preference for early intensive behavioral intervention and a comparison group ( n=21 ) identified as receiving treatment as usual . Prospect i ve assessment was undertaken before treatment , after 1 year of treatment , and again after 2 years . Groups did not differ on assessment s at baseline but after 2 years , robust differences favoring intensive behavioral intervention were observed on measures of intelligence , language , daily living skills , positive social behavior , and a statistical measure of best outcome for individual children . Measures of parental well-being , obtained at the same three time points , produced no evidence that behavioral intervention created increased problems for either mothers or fathers of children receiving it",
"ABSTRACT . Although previous studies have shown favorable results with early intensive behavioral treatment ( EIBT ) for children with autism , it remains important to replicate these findings , particularly in community setting s. The authors conducted a 3-year prospect i ve outcome study that compared 2 groups : ( 1 ) 21 children who received 35 to 40 hours per week of EIBT from a community agency that replicated Lovaas ' model of EIBT and ( 2 ) 21 age- and IQ-matched children in special education classes at local public schools . A quasi-experimental design was used , with assignment to groups based on parental preference . Assessment s were conducted by independent examiners for IQ ( Bayley Scales of Infant Development or Wechsler Preschool and Primary Scales of Intelligence ) , language ( Reynell Developmental Language Scales ) , nonverbal skill ( Merrill-Palmer Scale of Mental Tests ) , and adaptive behavior ( Vinel and Adaptive Behavior Scales ) . Analyses of covariance , with baseline scores as covariates and Year 1 - 3 assessment s as repeated measures , revealed that , with treatment , the EIBT group obtained significantly higher IQ ( F = 5.21 , p = .03 ) and adaptive behavior scores ( F = 7.84 , p = .01 ) than did the comparison group . No difference between groups was found in either language comprehension ( F = 3.82 , p = .06 ) or nonverbal skill . Six of the 21 EIBT children were fully included into regular education without assistance at Year 3 , and 11 others were included with support ; in contrast , only 1 comparison child was placed primarily in regular education . Although the study was limited by the nonr and om assignment to groups , it does provide evidence that EIBT can be successfully implemented in a community setting",
"OBJECTIVE To evaluate a training course for parents , design ed to help them underst and autism spectrum disorder and to facilitate social communication with their young child . STUDY DESIGN Controlled trial for 51 children aged 24 to 48 months , whose parents received either immediate intervention or delayed access to the course . Outcome was measured 7 months after recruitment in parents ' use of facilitative strategies , stress , adaptation to the child ; and in children 's vocabulary size , behavior problems , and social communication skills . RESULTS Taking into account scores at recruitment , child 's level of ability , diagnostic grouping , and the interval between assessment s , a significant advantage was found for the intervention group in parents ' observed use of facilitative strategies and in children 's vocabulary size . CONCLUSIONS The training course is well received by parents and has a measurable effect on both parents ' and children 's communication skills",
"The acquisition of social communication skills is a major challenge faced by children with autism . This pilot study investigated the effects of the Stronger Families Project , a social-pragmatic intervention , on the communication and symbolic abilities of 16 children aged 2–4 years with autism . St and ardized measures of the child 's communication and symbolic behaviour were conducted by independent observers at a university clinic pre and post-intervention , and parents were interviewed to determine the impact of variables such as maternal stress and competence on the child 's social communication . Changes in some communication and symbolic behaviours occurred following the Stronger Families Project intervention according to parent report . However , improvements based on ratings by independent observers were not significant . Results are discussed in relation to the assessment of changes in the social communication and symbolic play of children with autism following intervention using clinical observation and parent report",
"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",
"UNLABELLED The relations between cognition and autism severity , head size and intervention outcome , were examined . Change in cognitive level with intervention was measured in children with autism and compared to children with developmental disabilities ( DD ) . Eighty-one children ( mean age 25.9 months ) with autism ( n=44 ) and DD ( n=37 ) were assessed at pre- and post 1 year of intervention . Cognitive abilities and autism severity were measured by st and ardized tests . Three pre-intervention cognitive level groups : normal ( IQ>90 ) , borderline ( 70 impaired ( 50 autism symptoms than the borderline and the normal cognitive groups . However , following intervention the groups did not differ in the change in core autism symptoms . IQ scores increased significantly more in the autism group than in the DD group . IQ improvements correlated significantly with reduction in autism symptoms and mostly in stereotyped behaviors . CONCLUSIONS Cognitive ability in autism is associated with autism severity . Two distinct subtypes based on cognitive level are identified . However , baseline cognitive level can not predict the progress rate in autism symptoms with intervention . Improvement of social-communicative behaviors and the intensive intervention are related to significant cognitive increments in autism"
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Introduction We mapped available evidence on performance measurement and management ( PMM ) strategies in primary healthcare ( PHC ) systems of low-income and middle-income countries ( LMICs ) . Widely used , their effectiveness remains inconclusive . This evidence gap map characterises existing research and evidence gaps . Methods Systematic mapping of performance measurement and management research in LMICs from 2000 to mid-2018 ; literature search es of seven academic data bases and institutional repositories of impact evaluations and systematic review s. Using a combination of manual screening and machine learning , four review ers appraised 38 088 titles and abstract s , and extracted meta data from 137 impact evaluations and 18 systematic review s that met the inclusion criteria . The result ing visual representation of the evidence base was uploaded to a web-based platform . Results Since 2000 , the number of studies has increased ; the first systematic review s were completed in 2010 . Two-thirds of the studies were conducted in sub-Saharan Africa and South Asia . R and omised controlled trials were the most frequently used study design . The evidence is concentrated in two types of PMM strategies : implementation strategies ( in-service training , continuing education , supervision ) and performance-based financing . Major gaps exist in accountability arrangements particularly the use of audit and feedback . The least studied types of outcomes were unintended effects , harm and social equity . Conclusions The evidence is clustered around interventions that are unlikely to achieve transformational change in health outcomes . The gaps identified suggest that routinely used PMM strategies are implemented without sufficient knowledge of their effects . Future efforts at re design ing PHC systems need to be informed by evidence on the most effective approaches for using PMM strategies
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"Background Inappropriate use and overuse of antibiotics is a serious concern in the treatment of upper respiratory tract infections ( URTIs ) , especially in developing countries . In recent decades , information disclosure and public reporting ( PR ) has become an instrument for encouraging good practice in healthcare . This study evaluated the impact of PR on antibiotic prescribing for URTIs in a sample of primary care institutions in China . Methods A matched-pair cluster-r and omized trial was undertaken in QJ city , with 20 primary care institutions participating in the trial . Participating institutions were matched into pairs before being r and omly assigned into a control and an intervention group . Prescription statistics were disclosed to patients , health authorities , and health workers monthly within the intervention group , starting from October 2013 . Outpatient prescriptions for URTIs were collected from both groups before ( 1st March to 31st May , 2013 ) and after the intervention ( 1st March to 31st May , 2014 ) . A total of 34,815 URTI prescriptions were included in a difference-in-difference analysis using multivariate linear or logistic regression models , controlling for patient attributes as well as institutional characteristics . Results Overall , 90 % URTI prescriptions required antibiotics and 21 % required combined use of antibiotics . More than 77 % of URTI prescriptions required intravenous ( IV ) injection or infusion of drugs . PR result ed in a 9 percentage point ( 95 % CI -17 to -1 ) reduction in the use of oral antibiotics ( adjusted RR = 39 % , P = 0.027 ) , while the use of injectable antibiotics remained unchanged . PR led to a 7 percentage point reduction ( 95 % CI -14 to 0 ; adjusted RR = 36 % ) in combined use of antibiotics ( P = 0.049 ) , which was largely driven by a significant reduction in male patients ( -7.5 % , 95 % CI -14 to -1 , P = 0.03 ) . The intervention had little impact on the use of IV injections or infusions , or the total prescription expenditure . Conclusions The results suggest that PR could improve prescribing practice s in terms of reducing oral antibiotics and combined use of antibiotics ; however , the impacts were limited . We suggest that PR would probably be enhanced by provider payment reform , management and training for providers , and health education for patients",
"Maternal health services continue to favour the wealthiest in lower and middle income countries . Debate about the potential of performance-based financing ( PBF ) to address these disparities continues . As PBF is adopted by countries , it is critical to underst and the equity effects for maternal services . The aim of this study is to examine the effects of PBF on equity in maternal health service use when no specific provisions target the poorest in the population . In Rw and a , PBF was design ed to increase health service use , which was universally low . Paired districts were r and omly assigned to intervention and control for PBF implementation . Using Rw and a 's Demographic Health Survey data from 2005 ( pre-intervention ) and 2007 - 8 ( post-intervention ) , a cluster-level panel data set of 7899 women 15 - 49 years of age from intervention ( 4477 ) and control districts ( 3422 ) was created . The impact of PBF on reported use of facility deliveries , antenatal care ( ANC ) and modern contraceptive use was estimated using a difference-in-differences model with community fixed effects . Interaction terms between wealth quintiles and PBF were estimated to identify the differential effect of PBF among poorer women . The probability of a facility delivery increased by 10 percentage points in the intervention when compared with the control districts ( P = 0.014 ) , while no significant effects were noted for ANC visits or modern contraceptive use . Service use increased for intervention and control population s and across all wealth quintiles from 2005 to 2007 , with no evidence that PBF was a pro-poor or a pro-rich strategy . Insurance remained a positive predictor of service use . This research suggests that if service use is uniformly low then a PBF programme that incentivizes select services , such as facility deliveries , may improve service use overall . However , if the equity gap is extreme , then a PBF programme without equity targets will do little to alleviate disparities",
"Background Malaria continues to be a prominent global public health challenge . This study tested the effectiveness of two service delivery models for reducing the malaria burden , e.g. supportive supervision of community health workers ( CHW ) and community mobilization in promoting appropriate health-seeking behaviour for febrile illnesses in Odisha , India . Methods The study population comprised 120 villages from two purposively chosen malaria-endemic districts , with 40 villages r and omly assigned to each of the two treatment arms , one with both supportive supervision and community mobilization and one with community mobilization alone , as well as an observational control arm . Outcome measures included changes in the utilization of bed nets and timely care-seeking for fever from a trained provider compared to the control group . Analysis was by intention-to-treat . Results Significant improvements were observed in the reported utilization of bed nets in both intervention arms ( 84.5 % in arm A and 82.4 % in arm B versus 78.6 % in the control arm ; p overall rates of treatment-seeking were equal across study arms , treatment-seeking from a CHW was higher in both intervention arms ( 28 % ; p = 0.005 and 27.6 % ; p = 0.007 ) than in the control arm ( 19.2 % ) . Fever cases were significantly more likely to visit a CHW and receive a timely diagnosis of fever in the combined interventions arm than in the control arm ( 82.1 % vs. 67.1 % ; p = 0.025 ) . Care-seeking from trained providers also increased with a substitution away from untrained providers . Further , fever cases from the combined interventions arm ( 60.6 % ; p = 0.004 ) and the community mobilization arm ( 59.3 % ; p = 0.012 ) were more likely to have received treatment from a skilled provider within 24 hours than fever cases from the control arm ( 50.1 % ) . In particular , women from the combined interventions arm were more likely to have received timely treatment from a skilled provider ( 61.6 % vs. 47.2 % ; p = 0.028 ) . Conclusion A community-based intervention combining the supportive supervision of community health workers with intensive community mobilization and can be effective in improving care-seeking and preventive behaviour and may be used to strengthen the national malaria control programme",
"High antibiotic prescribing and antimicrobial resistance in patients attending primary care have been reported in South America . Very few interventions targeting general practitioners ( GPs ) to decrease inappropriate antibiotic prescribing have been investigated in this region . This study assessed the effectiveness of online feedback on reducing antibiotic prescribing in patients with suspected respiratory tract infections ( RTIs ) attending primary care . The aim was to reduce antibiotic prescribing in patients with acute bronchitis and acute otitis media . Both are RTIs for which antibiotics have a very limited effect . A cluster r and omized two-arm control trial was implemented . Healthcare centres from Bolivia , Argentina , Paraguay and Uruguay participating in the quality improvement program HAPPY AUDIT were r and omly allocated to either intervention or control group . During ten consecutive weeks , GPs in the intervention group received evidence -based online feedback on the management of suspected RTIs . In patients with acute bronchitis , the intervention reduced the antibiotic prescribing rate from 71.6 % to 56 % ( control group from 61.2 % to 52 % ) . In patients with acute otitis media , the intervention reduced the antibiotic prescribing from 94.8 % to 86.2 % ( no change in the control group ) . In all RTIs , the intervention reduced antibiotic prescribing rate from 37.4 % to 28.1 % ( control group from 29 % to 27.2 % ) . Online evidence -based feedback is effective for reducing antibiotic prescribing in patients with RTIs attending primary care in South America",
"Background and objectives Many clinical management guidelines for chronic diseases have been published , but they have not been put into practice by busy clinicians at primary care levels . This study evaluates the implementation of national guidelines incorporated within a structured diabetes and hypertension clinical record ( SR ) in Cape Town in a r and omised controlled trial ( RCT ) . Methods Eighteen public sector community health centres ( CHC ) were r and omly selected and allocated as intervention or control CHC . At each clinic , 25 patients with diabetes and 35 patients with hypertension were enrolled at baseline . Question naires were completed , blood sample s were collected , blood pressure ( BP ) and anthropometric measures were taken and patient records were audited . SR with clinical guideline prompts were introduced at the intervention clinics after training doctors in their use and suggestions to incorporate them in regular patient records . Contact was maintained during the year of intervention with the clinic staff . A follow-up survey was conducted 1 year later to assess BP and HbA1c , and the patient records were examined to ascertain the extent of use of the SR in the intervention clinics . In-depth interviews were conducted with doctors and nurses to record their response to the intervention . Results The intervention evaluated in this RCT had no impact on either diabetes or hypertension control . In the intervention clinics , less than 60 % of the patient folders contained the SR and when present was seldom used . Although the staff were well disposed to the research team , their workload prohibited them from undertaking a true evaluation of the SR , and overall they did not perceive the SR as supporting their current process of patient care . Conclusions No benefit to diabetes of hypertension care by introducing and availability of the staff in the use of the SR was shown in this RCT . The process measures suggest that the SR was not widely used by the healthcare provided in the primary care clinics",
"Background : Studies regarding the effectiveness of CME programmes on physicians ’ behaviour and communication skills showed inconsistent results . Few r and omized controlled trials have been conducted in Asia . Methods : To evaluate the effectiveness of a 4 2-hour education programme to improve GP interviewing behaviours , 16 general practitioners were r and omized to the intervention and control groups , respectively . Physicians assigned to the intervention group received 8 hours of training emphasizing interviewing behaviours in the diagnosis and treatment of depression and generalized anxiety disorders ( GDS ) . Those assigned to the control group did not receive any training until the completion of study . St and ardized patients were used to evaluate the performance of physicians . Two consultations before and after enrolling in the education programme were videotaped . Independent evaluations of consultations were made by a trained clinical psychologist and a social worker blinded to the study status of physicians . The rating schedule for the videotapes was based on the tasks listed on the Calgary Cambridge Observation Guide . Results : The change of score between the intervention and control physicians was significantly different in ‘ active listening and facilitating patients ’ response ’ ( p = 0.011 ) with the intervention physicians having improvement of score . For ‘ non-verbals ’ , ‘ underst and ing patient 's perspective ’ and ‘ negotiating mutual plan of action ’ , positive change of score in the intervention physicians were seen when compared to that of the control , although the difference did not reach statistical significance ( p = 0.06 , p = 0.05 , p = 0.06 , respectively ) . However , for ‘ opening ’ , ‘ structuring the consultation ’ , ‘ explanation and planning ’ and ‘ closure ’ , there were no statistical significant differences between control and intervention group . Conclusions : Our results showed that only certain communication skills , such as active listening and facilitating patient 's response , can be taught in the management of depression and generalized anxiety disorder ( GAD ) in Chinese primary care physicians",
"Background : Retention in care is critical for improving HIV-infected maternal outcomes and reducing vertical transmission . Health systems ' interventions such as continuous quality improvement ( CQI ) may support health services to address factors that affect the delivery of HIV-related care and thereby influence rates of retention-in-care . Methodology : We evaluated the effect of a CQI intervention on retention-in-care at 6 months postpartum of pregnant women and mothers living with HIV who had been started on lifelong antiretroviral treatment . Thirty-two health care facilities were r and omized to either implement the intervention or not . We considered women fully retained in care when they attended the 6-month postpartum visit and did not miss any previous scheduled visit by more than 30 days . Results : Five hundred eleven women living with HIV attending antenatal clinics at 26 facilities were included in the analysis . Median age at enrolment was 27 years and gestational age was 20 weeks . Seventy-one percent of women were seen at 6-month postpartum irrespective of missing any scheduled visit . However , 43 % of women were fully retained at 6-month postpartum and did not miss any scheduled visit based on our stringent study definition of retention . There was no significant difference in retention at 6 months between the intervention and control arms [ 44 % vs. 41 % , relative risk : 1.08 ; 95 % confidence interval ( CI ) : 0.78 to 1.49 ] . Initiation of ARV prophylaxis among infants within 72 hours was not different by study arm ( 66.0 % vs. 74.7 % , relative risk = 0.95 ; 95 % CI : 0.84 to 1.07 ) but rates of early infant testing at 4–6 weeks were higher in intervention sites ( 48.8 % vs. 25.3 % , adjusted relative risk : 1.76 ; 95 % CI : 1.27 to 2.42 ) . Conclusions : CQI as implemented in this study did not differ across study arms in the rates of retention . Several intervention design or implementation issues or other context ual constraints may explain the absence of effect",
"Delivering health care to mystery patients Many families in developing countries do not have access to medical doctors and instead receive health care from informal providers . Das et al. used “ mystery ” patients ( trained actors ) to test whether a 9-month training program improved the quality of care delivered by informal providers in West Bengal ( see the Perspective by Powell-Jackson ) . The patients did not identify themselves to the providers and were not told which providers had participated in the training program . The results of this blinded assessment showed that medical doctors delivered better care than informal providers but that the training program closed much of the gap . Science , this issue p. 80 ; see also p. 34 Training helped informal providers deliver better care for angina , diarrhea , and asthma . [ Also see Perspective by Powell-Jackson ] INTRODUCTION In rural India , health care providers without formal medical training and self-declared “ doctors ” are sought for up to 75 % of primary care visits . The frequent use of such informal providers , despite legal prohibitions on their practice s , in part reflects the absence of trained medical professionals in rural locations . For example , in the majority of villages in the Indian states of Rajasthan , Madhya Pradesh , and West Bengal , informal providers are the only proximate source of health care . RATIONALE The status of informal providers in the complex Indian health system is the subject of a highly charged debate among policy-makers and the medical establishment . The official view of the establishment is that fully trained providers are the only legitimate source of health care , and training informal providers legitimizes an illegal activity and worsens population health outcomes . In contrast , given the lack of availability of trained providers and the fact that informal providers are tightly linked with the communities that they serve , others believe that training can serve as a stopgap measure to improve health care in t and em with better regulation and reform of the public health care system . However , despite the policy interest and important ramifications for the country , there is little evidence regarding the benefits ( or lack thereof ) of training informal providers . We report on the impact of a multitopic training program for informal providers in the Indian state of West Bengal that provided 72 sessions of training over 9 months . We used a r and omized controlled trial design , together with visits by unannounced st and ardized patients ( “ mystery clients ” ) , to measure the extent to which training could improve the clinical practice of informal providers over the range of conditions that they face . The conditions presented by st and ardized patients were blinded from program implementers . Therefore , we view the evaluation of this multitopic training program as a measure of impact on primary care in general . St and ardized patient data are accompanied by data from day-long clinical observations , providing a comprehensive picture of provider practice . Our study also benchmarks the impact of training against the performance of doctors in public primary health centers serving the same region . Lastly , it explores whether the training affected patient dem and for informal providers . RESULTS Mean attendance at each training session was 56 % [ 95 % confidence interval ( CI ) : 51 , 62 % ] , with no contamination from the control group . Using st and ardized patient data , we find that providers allocated to the training group were 4.1 ( 1.7 , 6.5 ) percentage points , or 15.2 % , more likely to adhere to condition-specific checklists than those in the control group . The training increased rates of correct case management by 7.9 ( 0.4 , 15.5 ) percentage points , or 14.2 % , and patient caseload by 0.8 to 1.8 ( 0.13 , 3.57 ) patients per day , or 7.6 to 17.0 % . Data from clinical observations show similar patterns . Although correct case management among doctors in public clinics was 14.7 ( –0.1 , 30.4 ) percentage points , or 28.3 % , higher than among untrained informal providers , the training program reduced this gap by half for providers with mean attendance and reduced the gap almost entirely for providers who completed the full course . However , the training had no effect on the use of unnecessary medicines and antibiotics , although both training- and control-group informal providers prescribed 18.8 ( 7.7 , 28.9 ) percentage points , or 28.2 % , fewer unnecessary antibiotics than public-sector providers . CONCLUSION Training informal providers increased correct case management rates but did not reduce the use of unnecessary medicines or antibiotics . At the same time , training did not lead informal providers to violate rules with greater frequency or worsen their clinical practice , both of which are concerns that have been raised by representatives of the Indian Medical Association . Our findings thus suggest that multitopic medical training may offer an effective short-run strategy to improved health care provision and complement critical investments in the quality of public care . Informal health care providers are the backbone of India ’s primary health care system . In rural India , up to 75 % of primary care visits are to informal providers . We evaluated a training program for these informal providers by using a r and omized controlled design . In our sample of 200 villages in West Bengal , there are 30 informal providers for every public-sector doctor . Health care providers without formal medical qualifications provide more than 70 % of all primary care in rural India . Training these informal providers may be one way to improve the quality of care where few alternatives exist . We report on a r and omized controlled trial assessing a program that provided 72 sessions of training over 9 months to 152 informal providers ( out of 304 ) . Using st and ardized patients ( “ mystery clients ” ) , we assessed clinical practice for three different conditions to which both providers and trainers were blinded during the intervention , representative of the range of conditions that these providers normally diagnose and treat . Training increased correct case management by 7.9 percentage points ( 14.2 % ) but did not affect the use of unnecessary medicines and antibiotics . At a program cost of $ 175 per trainee , our results suggest that multitopic medical training offers an effective short-run strategy to improve health care",
"Background Maternal , perinatal and neonatal mortality remains high in low-income countries . We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi . Methods We evaluated a rural participatory women ’s group community intervention ( CI ) and a quality improvement intervention at health centres ( FI ) via a two-by-two factorial cluster r and omized controlled trial . Consenting pregnant women were followed-up to 2 months after birth using key informants . Primary outcomes were maternal , perinatal and neonatal mortality . Clusters were health centre catchment areas assigned using stratified computer-generated r and omization . Following exclusions , including non-birthing facilities , 61 clusters were analysed : control ( 17 clusters , 4912 births ) , FI ( 15 , 5335 ) , CI ( 15 , 5080 ) and FI + CI ( 14 , 5249 ) . This trial was registered as International St and ard R and omised Controlled Trial [ IS RCT N18073903 ] . Outcomes for 14 576 and 20 576 births were recorded during baseline ( June 2007–September 2008 ) and intervention ( October 2008–December 2010 ) periods . Results For control , FI , CI and FI + CI clusters neonatal mortality rates were 34.0 , 28.3 , 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2 , 55.1 , 48.0 and 48.4 per 1000 births , during the intervention period . Adjusting for clustering and stratification , the neonatal mortality rate was 22 % lower in FI + CI than control clusters ( OR = 0.78 , 95 % CI 0.60–1.01 ) , and the perinatal mortality rate was 16 % lower in CI clusters ( OR = 0.84 , 95 % CI 0.72–0.97 ) . We did not observe any intervention effects on maternal mortality . Conclusions Despite implementation problems , a combined community and facility approach using participatory women ’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi",
"Background Nutrition training can boost competence of health workers to improve children ’s feeding practice s. In this way , child undernutrition can be ameliorated in general population s. However , evidence is lacking on efficacy of such interventions among Human Immunodeficiency Virus (HIV)-positive children . We aim ed to examine the efficacy of a nutrition training intervention to improve midlevel providers ’ ( MLPs ) nutrition knowledge and feeding practice s and the nutrition statuses of HIV-positive children in Tanga , Tanzania . Methods This cluster-r and omized controlled trial was conducted in 16 out of 32 care and treatment centers ( CTCs ) in Tanga . Eight CTCs were assigned to the intervention arm and a total of 16 MLPs received nutrition training and provided nutrition counseling and care to caregivers of HIV-positive children . A total of 776 pairs of HIV-positive children and their caregivers were recruited , of whom 397 were in the intervention arm . Data were analyzed using instrumental variable r and om effects regression with panel data to examine the efficacy of the intervention on nutrition status through feeding practice s. Results Mean nutrition knowledge scores were higher post-training compared to pre-training among MLPs ( 37.1 vs. 23.5 , p mean increment weight gain of 300 g was also observed at follow-up compared to baseline among children of the intervention arm . Feeding frequency and dietary diversity improved following the intervention and a 6 months follow-up ( p of feeding frequency and dietary diversity were associated with a 0.15-unit and a 0.16-unit respectively decrease in the child underweight ( p Conclusions Nutrition training improved nutrition knowledge among MLPs caring for HIV-positive children attending CTCs in Tanga , Tanzania . Caregivers ’ feeding practice s also improved , which in turn led to a modest weight gain among HIV-positive children . To sustain weight gain , efforts should be made to also improve households ’ food security and caregivers ’ education in addition to inservice nutrition trainings . The protocol was registered on 15/02/2013 , before the recruitment at IS RCT N trial registry with the trial registration number : IS RCT N65346364",
"Complementary feeding practice s are often inadequate in developing countries , result ing in a significant nutritional decline between 6 and 18 mo of age . We assessed the effectiveness of an educational intervention to promote adequate complementary feeding practice s that would be feasible to sustain with existing re sources . The study was a cluster r and omized controlled trial in communities in the state of Haryana in India . We developed the intervention through formative research . Eight communities were pair matched on their baseline characteristics ; one of each pair was r and omly assigned to receive the intervention and the other to no specific feeding intervention . Health and nutrition workers in the intervention communities were trained to counsel on locally developed feeding recommendations . Newborns were enrolled in all of the communities ( 552 in the intervention and 473 in the control ) and followed up every 3 mo to the age of 18 mo . The main outcome measures were weights and lengths at 6 , 9 , 12 , and 18 mo and complementary feeding practice s at 9 and 18 mo . All analyses were by intent to treat . In the overall analyses , there was a small but significant effect on length gain in the intervention group ( difference in means 0.32 cm , 95 % CI , 0.03 , 0.61 ) . The effect was greater in the subgroup of male infants ( difference in mean length gain 0.51 cm , 95 % CI 0.03 , 0.98 ) . Weight gain was not affected . Energy intakes from complementary foods overall were significantly higher in the intervention group children at 9 mo ( mean + /- SD : 1556 + /- 1109 vs. 1025 + /- 866 kJ ; P growth is limited . Factors that limit physical growth in such setting s must be better understood to plan more effective nutrition programs",
"In China , health care providers have traditionally been paid fee-for-service and overprescribing and high out-of-pocket spending are common . In this study , township health centers in two counties were assigned almost r and omly to two groups : in one , fee-for-service was replaced by a global capitated budget ; in the other , by a mix of global capitated budget and pay-for-performance . Performance captured inter alia \" irrational \" drug prescribing ; 20 percent of the global capitated budget was withheld each quarter , points were deducted for failure to meet targets , and some of the withheld budget was returned in line with the points deducted . Outcomes included appropriate prescribing and prescription cost , data on which were obtained by digitizing prescriptions from a month just before the reform and from the same month a year later . Impacts were assessed via multivariate differences-in-differences with township health center fixed effects . To reduce bias from non-r and omness in assignment , the sample was trimmed by coarsened exact matching . Pay-for-performance reduced inappropriate prescribing significantly and substantially in the county where the initial level was above the penalty threshold , but end-line rates were still appreciable ; no effects were seen in the county where initial levels were around or below the threshold , or on out-of-pocket spending in either county",
"Background Health worker compliance with established best- practice clinical and public health guidelines may be enhanced by customized checklists of care and clinical decision support driven by point-of-care data entry into an electronic health registry . The public health system of Palestine is currently implementing a national electronic registry ( eRegistry ) for maternal and child health . This trial is embedded in the national implementation and aims to assess the effectiveness of the eRegistry ’s interactive checklists and clinical decision support , compared with the existing paper based records , on improving the quality of care for pregnant women . Methods This two-arm cluster r and omized controlled trial is conducted in the West Bank , Palestine , and includes 120 clusters ( primary healthcare clinics ) with an average annual enrollment of 60 pregnancies . The intervention tool is the eRegistry ’s interactive checklists and clinical decision support implemented within the District Health Information System 2 ( DHIS2 ) Tracker software , developed and customized for the Palestinian context . The primary outcomes reflect the processes of essential interventions , namely timely and appropriate screening and management of : 1 ) anemia in pregnancy ; 2 ) hypertension in pregnancy ; 3 ) abnormal fetal growth ; 4 ) and diabetes mellitus in pregnancy . The composite primary health outcome encompasses five conditions representing risk for the mother or baby that could have been detected or prevented by high- quality antenatal care : moderate or severe anemia at admission for labor ; severe hypertension at admission for labor ; malpresentation at delivery undetected during pregnancy ; small for gestational age baby at delivery undetected during pregnancy ; and large for gestational age baby at delivery . Primary analysis at the individual level taking the design effect of the clustering into account will be performed as intention-to-treat . Discussion This trial , embedded in the national implementation of the eRegistry in Palestine , allows the assessment of process and health outcomes in a large-scale pragmatic setting . Findings will inform the use of interactive checklists and clinical decision support driven by point-of-care data entry into an eRegistry as a health systems-strengthening approach . Trial registration IS RCT N trial registration number , IS RCT N18008445 . Registered on 6 April 2017",
"Background Newborn health is a key issue in addressing the survival of children under five years old , particularly in low and middle income countries , and the evidence base for newborn health interventions continues to evolve . Over the last decade , maternal and under five-year-old mortality and morbidity rates have been successfully reduced in Cambodia , but newborn health has lagged behind . Evidence suggests that an important proportion of newborn mortality both globally and in Cambodia is attributable to infections and sepsis . While initiatives are being implemented to address some causes of newborn illness ( related to pre-term birth and asphyxia ) , a country-level approach to reducing infections has not been formulated . The Newborn Infection Control and Care Initiative ( NICCI ) is a community and health facility linked intervention to improve health outcomes for newborns . Methods / Design The present study applies a cluster r and omized trial , using a stepped wedge design , to assess the impact of a package intervention on newborn health . The intervention components include addressing infection control in the perinatal period in health facilities , promoting infection prevention and control practice s in health center and home environments , and improving the timeliness of referrals for newborns with suspected infections to appropriate health facilities , by linking families to the medical system through a network of community based volunteers who will make home visits to families in the first week of a newborn ’s life . Discussion The NICCI trial is design ed to complement and enhance the Cambodian Ministry of Health strategies and objectives for maternal and newborn care . Results of the study will help to inform policy and the possible scale-up of newborn health interventions in the country . Trial registration This trial was registered with Clinical trials.gov ( identifier : NCT02271737 ) on 5 October 2014",
"Background Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries . These differences have been related to poor access to and poor quality of obstetric and neonatal care . Methods This trial tested the hypothesis that teams of health care providers , administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations . In seven geographic areas in five low-income and one middle-income country , most with high perinatal mortality rates and substantial numbers of home deliveries , we performed a cluster r and omized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport , community birth attendant training in problem recognition , and facility staff training in the management of obstetric and neonatal emergencies . The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Results Despite extensive effort in all sites in each of the three intervention areas , no differences emerged in the primary or any secondary outcome between the intervention and control clusters . In both groups , the mean perinatal mortality was 40.1/1,000 births ( P = 0.9996 ) . Neither were there differences between the two groups in outcomes in the last six months of the project , in the year following intervention cessation , nor in the clusters that best implemented the intervention . Conclusions This cluster r and omized comprehensive , large-scale , multi-sector intervention did not result in detectable impact on the proposed outcomes . While this does not negate the importance of these interventions , we expect that achieving improvement in pregnancy outcomes in these setting s will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial , and without them provider training and community mobilization will not be sufficient . Our results highlight the critical importance of evaluating outcomes in r and omized trials , as interventions that should be effective may not be . Trial registration Clinical Trials.gov",
"Background Pneumonia is a leading cause of death among children under five years of age . The Integrated Management of Childhood Illness strategy can improve the quality of care for pneumonia and other common illnesses in developing countries , but adherence to these guidelines could be improved . We evaluated an intervention in Benin to support health worker adherence to the guidelines after training , focusing on pneumonia case management . Methods We conducted a r and omized trial . After a health facility survey in 1999 to assess health care quality before Integrated Management of Childhood Illness training , health workers received training plus either study supports ( job aids , non-financial incentives and supervision of workers and supervisors ) or \" usual \" supports . Follow-up surveys were conducted in 2001 , 2002 and 2004 . Outcomes were indicators of health care quality for Integrated Management-defined pneumonia . Further analyses included a graphical pathway analysis and multivariable logistic regression modelling to identify factors influencing case-management quality . Results We observed 301 consultations of children with non-severe pneumonia that were performed by 128 health workers in 88 public and private health facilities . Although outcomes improved in both intervention and control groups , we found no statistically significant difference between groups . However , training proceeded slowly , and low- quality care from untrained health workers diluted intervention effects . Per- protocol analyses suggested that health workers with training plus study supports performed better than those with training plus usual supports ( 20.4 and 19.2 percentage-point improvements for recommended treatment [ p = 0.08 ] and \" recommended or adequate \" treatment [ p = 0.01 ] , respectively ) . Both groups tended to perform better than untrained health workers . Analyses of treatment errors revealed that incomplete assessment and difficulties processing clinical findings led to missed pneumonia diagnoses , and missed diagnoses led to inadequate treatment . Increased supervision frequency was associated with better care ( odds ratio for recommended treatment = 2.1 [ 95 % confidence interval : 1.1 - 3.9 ] per additional supervisory visit ) . Conclusion Integrated Management of Childhood Illness training was useful , but insufficient , to achieve high- quality pneumonia case management . Our study supports led to additional improvements , although large gaps in performance still remained . A simple graphical pathway analysis can identify specific , common errors that health workers make in the case-management process ; this information could be used to target quality improvement activities , such as supervision ( Clinical Trials.gov number NCT00510679 )",
"Optimizing quality of care for malaria and other febrile illnesses is a complex challenge of major public health importance . To evaluate the impact of an intervention aim ing to improve malaria case management on the health of community children , a cluster-r and omized trial was conducted from 2010–2013 in Tororo , Ug and a , where malaria transmission is high . Twenty public health centers were included ; 10 were r and omized in a 1:1 ratio to intervention or control . Households within 2 km of health centers provided the sampling frame for the evaluation . The PRIME intervention included training in fever case management using malaria rapid diagnostic tests ( mRDTs ) , patient-centered services , and health center management ; plus provision of mRDTs and artemether – lumefantrine . Cross-sectional community surveys were conducted at baseline and endline ( N = 8,766 ) , and a cohort of children was followed for approximately 18 months ( N = 992 ) . The primary outcome was prevalence of anemia ( hemoglobin children under 5 years of age in the final community survey . The intervention was delivered successfully ; however , no differences in prevalence of anemia or parasitemia were observed between the study arms in the final community survey or the cohort . In the final survey , prevalence of anemia in children under 5 years of age was 62.5 % in the intervention versus 63.1 % in control ( adjusted risk ratio = 1.01 ; 95 % confidence interval = 0.91–1.13 ; P = 0.82 ) . The PRIME intervention , focusing on training and commodities , did not produce the expected health benefits in community children in Tororo . This challenges common assumptions that improving quality of care and access to malaria diagnostics will yield health gains",
"Objective To evaluate the Indian Integrated Management of Neonatal and Childhood Illness ( IMNCI ) programme , which integrates improved treatment of illness for children with home visits for newborn care , to inform its scale-up . Design Cluster r and omised trial . Setting 18 clusters ( population 1.1 million ) in Haryana , India . Participants 29 667 births in intervention clusters and 30 813 in control clusters . Intervention Community health workers were trained to conduct postnatal home visits and women ’s group meetings ; physicians , nurses , and community health workers were trained to treat or refer sick newborns and children ; supply of drugs and supervision were strengthened . Main outcome measures Neonatal and infant mortality ; newborn care practice s. Results The infant mortality rate ( adjusted hazard ratio 0.85 , 95 % confidence interval 0.77 to 0.94 ) and the neonatal mortality rate beyond the first 24 hours ( adjusted hazard ratio 0.86 , 0.79 to 0.95 ) were significantly lower in the intervention clusters than in control clusters . The adjusted hazard ratio for neonatal mortality rate was 0.91 ( 0.80 to 1.03 ) . A significant interaction was found between the place of birth and the effect of the intervention for all mortality outcomes except post-neonatal mortality rate . The neonatal mortality rate was significantly lower in the intervention clusters in the subgroup born at home ( adjusted hazard ratio 0.80 , 0.68 to 0.93 ) but not in the subgroup born in a health facility ( 1.06 , 0.91 to1.23 ) ( P value for interaction=0.001 ) . Optimal newborn care practice s were significantly more common in the intervention clusters . Conclusions Implementation of the IMNCI result ed in substantial improvement in infant survival and in neonatal survival in those born at home . The IMNCI should be a part of India ’s strategy to achieve the millennium development goal on child survival . Trial registration Clinical trials NCT00474981 ; ICMR Clinical Trial Registry CTRI/2009/091/000715",
"Background Adolescent-friendly policies aim to tailor HIV services for adolescents and young adults aged 10–24 years ( AYA ) to promote health outcomes and improve retention in HIV care and treatment . However , few interventions focus on improving healthcare worker ( HCW ) competencies and skills for provision of high- quality adolescent care . St and ardized patients ( SPs ) are trained actors who work with HCWs in mock clinical encounters to improve clinical assessment , communication , and empathy skills . This stepped-wedge r and omized controlled trial will evaluate a clinical training intervention utilizing SPs to improve HCW skills in caring for HIV-positive AYA , result ing in increased retention in care . Methods / design The trial will utilize a stepped-wedge design to evaluate a training intervention using SPs to train HCWs in assessment , communication , and empathy skills for AYA HIV care . We will recruit 24 clinics in Kenya with an active electronic medical record ( EMR ) system and at least 40 adolescents enrolled in HIV care per site . Stratified r and omization by county will be used to assign clinics to one of four waves – time periods when they receive the intervention – with each wave including six clinics . From each clinic , up to 10 HCWs will participate in the training intervention . SP training includes didactic sessions in adolescent health , current guidelines , communication skills , and motivational interviewing techniques . HCW participants will rotate through seven st and ardized SP scenarios , followed by SP feedback , group debriefing , and remote expert evaluation . AYA outcomes will be assessed using routine clinic data . The primary outcome is AYA retention in HIV care , defined as returning for first follow-up visit within 6 months of presenting to care , or returning for a first follow-up visit after re-engagement in care in AYA with a previous history of being lost to follow-up . Secondary outcomes include HCW competency scores , AYA satisfaction with care , and AYA clinical outcomes including CD4 and viral load . Additional analyses will determine cost-effectiveness of the intervention . Discussion This trial will contribute valuable information to HIV programs in Kenya and other low-re source setting s , providing a potentially scalable strategy to improve quality of care and retention in critical HIV services in this population .Trial registration Clinical Trials.gov , ID : NCT02928900 . Registered 26 August 2016",
"Background Nearly 3 million people in re source -poor countries receive antiretrovirals for the treatment of HIV/AIDS , yet millions more require treatment . Key barriers to treatment scale up are shortages of trained health care workers , and challenges integrating HIV/AIDS care with primary care . The research PALM PLUS ( Practical Approach to Lung Health and HIV/AIDS in Malawi ) is an intervention design ed to simplify and integrate existing Malawian national guidelines into a single , simple , user-friendly guideline for mid-level health care workers . Training utilizes a peer-to-peer educational outreach approach . Research is being undertaken to evaluate this intervention to generate evidence that will guide future decision-making for consideration of roll out in Malawi . The research consists of a cluster r and omized trial in 30 public health centres in Zomba District that measures the effect of the intervention on staff satisfaction and retention , quality of patient care , and costs through quantitative , qualitative and health economics methods . Results and outcomes In the first phase of qualitative inquiry respondents from intervention sites demonstrated in-depth knowledge of PALM PLUS compared to those from control sites . Participants in intervention sites felt that the PALM PLUS tool empowered them to provide better health services to patients . Interim staff retention data shows that there were , on average , 3 to 4 staff departing from the control and intervention sites per month . Additional qualitative , quantitative and economic analyses are planned . The partnershipDignitas International and the Knowledge Translation Unit at the University of Cape Town Lung Institute have led the adaptation and development of the PALM PLUS intervention , using experience gained through the implementation of the South African precursor , PALSA PLUS . The Malawian partners , REACH Trust and the Research Unit at the Ministry of Health , have led the qualitative and economic evaluations . Dignitas and Ministry of Health have facilitated interaction with implementers and policy-makers . Challenges and successesThis initiative is an example of South-South knowledge translation between South Africa and Malawi , mediated by a Canadian academic-NGO hybrid . Our success in developing and rolling out PALM PLUS in Malawi suggests that it is possible to adapt and implement this intervention for use in other re source -limited setting ",
"IN THE EARLY 1890S , DR WILLIAM HALSTED DEVELOPED radical mastectomy for breast cancer . Surgeons performed the Halsted procedure for more than 80 years even though there was little systematic evidence for its success . Then a new breed of scholars subjected the procedure to formal methods of evaluation unknown to Halsted . The methods —r and omized controlled trials ( RCTs ) principal among them — led to a surprise : radical mastectomy had no advantage over simpler forms of treatment . This is but 1 example of the hard-won victory of evidence over belief in medicine . The pioneers of the formal evaluation of medical practice s raised questions that traditional practitioners did not welcome . But in time , formal evaluation prevailed . The pioneers developed a hierarchy of evidentiary rigor relating the design of a study to the confidence that could be placed in the findings , from the lowly , nearly valueless anecdote to the royalty of evidence , the RCT . Concurrently , a similar story of hard-won learning unfolded in the so-called quality movement . Scholars illuminated the scale and types of defects in the processes of care and the outcomes , including high rates of unscientific care , inappropriate care , geographic variations in practice , latent disagreements among specialists , and oftenunrecognized medical injury to patients . Like the pioneers of evidence -based medicine , students of medical quality were at first largely ignored , but no longer . In 1999 and 2001 , the Institute of Medicine published 2 l and mark reports on the evidence for quality failures and called urgently for re design of care systems to achieve improvements . The story could end here happily with 2 great streams of endeavor merging into a framework for conjoint action : improving clinical evidence and improving the process of care . Instead , the 2 endeavors are often in unhappy tension . Neither disputes that progress toward health care ’s main goal , the relief of illness and pain , requires research of many kinds : basic , clinical , systems , epidemiologic . The disagreement centers on epistemology — ways to get at “ truth ” and how those ways should vary depending on the knowledge sought . Individuals most involved in day-to-day improvement work fear that if “ evidence ” is too narrowly defined and the approach to gathering evidence too severely constrained , progress may be the victim . For example , the RCT is a powerful , perhaps unequaled , research design to explore the efficacy of conceptually neat components of clinical practice —tests , drugs , and procedures . For other crucially important learning purpose s , however , it serves less well . Recent controversies about the evaluation of rapid response teams provide a case in point . These controversies show the importance of adjusting research methods to fit research questions . Although only 10 % to 15 % of in patients resuscitated outside intensive care units survive to hospital discharge , early warning signs are present in a large percentage of patients who ultimately experience cardiac arrest . Rapid response team systems bring expert clinicians to the bedsides of deteriorating patients before arrest occurs . In the mid 1990s , based largely on reports from Australian investigators , the Institute for Healthcare Improvement and others began introducing the concept to willing hospitals . Local experience strongly suggested that these systems often , although not always , were associated with improved outcomes , including reduced anxiety among nursing staff ; increased interdisciplinary teamwork ; decreased cardiac arrests outside of intensive care units ; and , in some cases , declines in mortality . The evidence base took a turn in June 2005 with the publication of the Medical Early Response Intervention and Therapy ( MERIT ) Study , a cluster r and omized prospect i ve trial that cl aim ed to find no beneficial effect of these teams on several primary outcomes . Controversy has continued since then regarding the scientific evidence for rapid response systems . In fact , the MERIT trial was not negative ; it was inconclusive . The study team encountered an array of serious problems in execution , common in social science . For example , although the study ’s power calculation assumed a baseline rate of 30 events per 1000 admissions , the actual rate proved to be fewer than 7 events per 1000 admissions ; thus , the study was ef fect ively underpowered by 500 % . Crosscontamination abounded ; some control hospitals implemented rapid response protocol s , and several study",
"Objective To develop and test a distance-learning programme to improve the quality and efficiency of family planning services in Guatemala . Methods The setting was rural family planning services in Guatemala . The study design was quasi-experimental with one intervention and one control group and with pre- and post-intervention measures . Two staff members from each of 20 r and omly selected health districts were trained as leaders of the training programme . In turn , the 40 trainers trained a total of 240 service providers , under the supervision of four health area facilitators . The results were compared with 20 r and omly selected control health districts . The intervention was a distance-learning programme including 40 in-class hours followed by 120 inservice practice hours spread over a 4-month period . Distinctively , the programme used a cascade approach to training , intensive supervision , and close monitoring and evaluation . Patient flow analysis was used to determine number of contacts , waiting times , and the interaction time between service providers and clients . Consultation observations were used to assess the quality and completeness of reproductive health information and services received by clients . Results The intervention showed a positive impact on reducing the number of contacts before the consultation and client waiting times . More complete services and better quality services were provided at intervention clinics . Some , but not all , of the study objectives were attained . The long-term impact of the intervention is as yet unknown . Conclusion Distance-learning programmes are an effective methodology for training health professionals in rural areas",
"Hypertension control rates are unacceptably low in China . The present study demonstrates if a customized , guideline -oriented training program can cost-effectively improve hypertension management in primary healthcare . Four typical community health centers in Beijing were selected and r and omized to intervention or control ( one urban and one rural each ) . A sample of 140 patients with hypertension and blood pressure uncontrolled was recruited from each center . Primary healthcare providers in intervention centers provided management to the recruited patients for 1 year after receiving training with customized hypertension management guidelines , and primary healthcare providers in control provided with usual care . Intention-to-treat analysis showed that hypertension control ( systolic blood pressure ( SBP ) diastolic blood pressure ( DBP ) Mean reductions of SBP and DBP were significantly larger in interventions . The intervention was cost-saving , with an average incremental cost-saving of US$ 20.3 per patient in urban sites and $ 7.0 per patient in rural sites . Corresponding results from per- protocol analysis were very similar . The customized , guideline -oriented hypertension management program in primary healthcare in China effectively improved blood pressure control and was cost-saving",
"Background Globally , almost 4 million newborns die during the first 4 weeks of life every year . By increased use of evidence -based knowledge in the healthcare system a large proportion of these neonatal deaths could be prevented . But there is a severe lack of knowledge on effective methods for successful implementation of evidence into practice , particularly in low- and middle-income countries . Recent studies have demonstrated promising results with increased survival among both mothers and newborns using community-based approaches . In Vietnam evidence -based guidelines on reproductive health were launched in 2003 and revised in 2009 . The overall objective of the current project is to evaluate if a facilitation intervention on the community level , with a problem-solving approach involving local representatives if the healthcare system and the community , results in improvements of neonatal health and survival . Methods / Design The study , which has been given the acronym NeoKIP ( Neonatal Health - Knowledge Into Practice ) , took place in 8 districts composed by 90 communes in a province in northern Vietnam , where neonatal mortality rate was 24/1000 in 2005 . A cluster r and omised design was used , allocating clusters , as defined as a commune and its correponding Commune Health Center ( CHC ) to either intervention or control arm . The facilitation intervention targeted staff at healthcare centres and key persons in the communes . The facilitator role was performed by lay women ( Women 's Union representatives ) using quality improvement techniques to initiate and sustain improvement processes targeting identified problem areas . The intervention has been running over 3 years and data were collected on the facilitation process , healthcare staff knowledge in neonatal care and their behaviour in clinical practice , and reproductive and perinatal health indicators . Primary outcome is neonatal mortality . Discussion The intervention is participatory and dynamic , focused on developing a learning process and a problem-solving cycle . The study recognises the vital role of the local community as actors in improving their own and their newborns ' health , and applies a bottom-up approach where change will be accomplished by an increasing awareness at and dem and from grass root level . By utilising the existing healthcare structure this intervention may , if proven successful , be well suited for scaling up . Trial registration Current Controlled Trials IS RCT",
"Malnutrition is common among children aged 6–24 months in developing countries . It increases the risk of mortality . Interventions to improve infant-feeding hold the promise of reducing malnutrition among these children . A study in Brazil has shown the success of training in communication and counselling skills among health workers in improving the nutritional status of young children . Questions were raised whether the method used in the study in Brazil would also be effective when applied in other countries . The aim of the present study was to reduce growth faltering in young children through proper nutrition-promotion techniques . The objective of the study was to determine the efficacy of training health workers in nutrition counselling in enhancing their communication skills and performance , improving feeding practice s , and reducing growth faltering in children aged 6–24 months . A cluster-r and omized controlled trial was carried out . The method used in this study was a replica of the method in a similar study in Pelotas , Brazil . Forty health centres were paired , and one centre of each pair was r and omly allocated to the intervention group , and the other to the control group . The Integrated Management of Childhood Illness ( IMCI ) module—‘Counsel the mother'—was used for training health workers in the health centres in the intervention group . Data from 36 paired health centres and 375 mothers and their children aged 6–24 months recruited from these health centres following consultation with health workers were included in analysis . Independent observers , masked to the intervention status , examined the performance of health workers within the first month after training . Mother-child pairs were visited at home within two weeks , 45 days , and 180 days after recruitment . Information was recorded on the feeding practice s , recall of the recommendations of health workers , and sociodemographic variables at these home-visits . Weight and length of the child were measured at each contact . The communication skills and consultation performance of health workers were significantly better in the intervention group than in the control group . The mothers ' recall of the recommendation of health workers and reported infant-feeding practice s were also significantly better in the intervention group than in the control group , even 180 days after the recruitment consultation . Growth faltering was less in the intervention group , with the largest effect observed among children in the age-group of 12 + months . These results indicate that training in IMCI feeding counselling can enhance the communication skills and performance of health workers . Improved feeding practice s of counselled mothers can , in turn , reduce growth faltering in their children",
"Background Diarrhoea and pneumonia contribute 30 % of deaths in children under 5 in Pakistan . Pakistan ’s Lady Health Workers Programme ( LHW-P ) covers about 60 % of the population but has had little impact in reducing morbidity and mortality related to these major childhood killers . An external evaluation of the LHW-P suggests that lack of supportive supervision of LHWs by lady health supervisors ( LHSs ) is a key determinant of this problem . Project NIGRAAN aims to improve knowledge and skills of LHWs and community caregivers through supervisory strategies employed by LHSs . Ultimately , community case management ( CCM ) of childhood pneumonia and diarrhoea will improve . Methods / Design NIGRAAN is a cluster-r and omised trial in District Badin , Pakistan . There are approximately 1100 LHWs supervised by 36 LHSs in Badin . For this study , each LHS serves as a cluster . All LHSs working permanently in Badin who regularly conduct and report field visits are eligible . Thirty-four LHSs have been allocated to either intervention or control arms in a ratio of 1:1 through computer-generated simple r and omisation technique . Five LHWs from each LHSs are also r and omly picked . All 34 LHSs and 170 LHWs will be actively monitored . The intervention consists of training to build LHS knowledge and skills , clinical mentorship and written feedback to LHWs . Pre- and post-intervention assessment s of LHSs , LHWs and community caregivers will be conducted via focus group discussion s , in-depth interviews , knowledge assessment question naires , skill assessment scorecards and household surveys . Primary outcome is improvement in CCM practice s of childhood diarrhoea and pneumonia and will be assessed at the cluster level . Discussion NIGRAAN takes a novel approach to implementation research and explores whether training of LHSs in supervisory skills results in improving the CCM practice s of childhood diarrhoea and pneumonia . No significant harm to participants is anticipated . The enablers and barriers towards improved CCM would provide recommendations to policymakers for scale up of this intervention nationally and regionally . Trial registration NIGRAAN is registered with the ‘ Australian New Zeal and Clinical Trials Registry ’ . Registration Number :",
"Background In developing countries like Malawi , further investigation is rare after patients with chronic cough test negative for tuberculosis . Chronic airways disease has presentations that overlap with tuberculosis . However , chronic airways disease is often unrecognised due to a lack of diagnostic services . Within developing countries , referral systems at primary health care level are weak and patients turn to unskilled informal health providers to seek health care . Delayed diagnosis and treatment of these diseases facilitates increased severity and tuberculosis transmission . The World Health Organisation developed the Practical Approach to Lung Health strategy which has been shown to improve the management of both tuberculosis and chronic airways disease . The guidelines address the need for integrated guidelines for tuberculosis and chronic airways disease . Engaging with informal health providers has been shown to be effective in improving health services uptake . However , it is not known whether engaging community informal health providers would have a positive impact in the implementation of the Practical Approach to Lung Health strategy . We will use a cluster r and omised controlled trial to determine the effect of using the two interventions to improve case detection and treatment of patients with tuberculosis and chronic airways disease . Methods A three-arm cluster r and omised trial design will be used . A primary health centre catchment population will form a cluster , which will be r and omly allocated to one of the arms . The first arm personnel will receive the Practical Approach to Lung Health strategy intervention . In addition to this strategy , the second arm personnel will receive training of informal health providers . The third arm is the control . The effect of interventions will be evaluated by community surveys . Data regarding the diagnosis and management of chronic cough will be gathered from primary health centres . Discussion This trial seeks to determine the effect of Informal Health Provider and Practical Approach to Lung Health interventions on the detection and management of chronic airways disease and tuberculosis at primary care level in Malawi . Trial registration The unique identification number for the registry is PACTR201411000910192 – 21 November",
"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",
"Background In many healthcare systems , client satisfaction has been considered as an important indicator of primary healthcare quality . Hence communication education might be leading to better quality of family planning services and higher client satisfaction . This study aim ed to evaluate to what extent the communication skills training program could improve client satisfaction . Methods This was a r and omized controlled trial undertaken in health centers of Mashhad University Medical Sciences , Mashhad , Iran from July to September 2004 . Eligible participants were from two population targets , including healthcare providers and their clients . All 35 health centers were r and omly divided into intervention ( n = 17 ) and control groups ( n = 18 ) . The healthcare providers were working in intervention centers ( n = 24 ) not in control centers ( n = 27 ) received an additional communication skills training program in spite of routine education . Data regarding communication knowledge , attitude , and skills from healthcare providers and the satisfaction rate from the their clients ( n = 47 client for each group ) were collected at two time points . Results This study showed that communication knowledge and skills of health workers improved significantly in the intervention group ( P of client satisfaction was significantly improved in the intervention group after 1 month follow-up ( p communication skills training program is an effective intervention and may improve the satisfaction rate of clients",
"Background Feeding practice s and child undernutrition can be improved when trained health workers provide proper nutrition counseling to caregivers . However , this important management component is difficult to achieve in countries where trained health workers are limited ; Tanzania is no exception . In rural and semi-urban areas , mid-level providers ( MLPs ) are left to manage diseases such as HIV/AIDS.Training health workers in nutrition has been shown to be an effective intervention among HIV-negative children elsewhere , but no studies have been conducted among HIV-positive children . Furthermore , in Tanzania and other countries with MLPs , no evidence currently exists demonstrating an improvement in nutrition among children who receive health services given by MLPs . This study thus aims to examine the efficacy of nutrition training of MLPs on feeding practice s and the nutrition status of HIV-positive children in Tanga , Tanzania . Methods / Design We will conduct a cluster r and omized controlled trial in care and treatment centers ( CTCs ) in Tanga , Tanzania . The CTCs will be the unit of r and omization . We will select 16 CTCs out of 32 for this study , of which we will r and omly assign 8 to the intervention arm and 8 to the control arm by coin flipping . From the selected CTCs we will attempt to recruit a total of 800 HIV-positive children aged 6 months to 14 years , half of whom will be receiving care and /or treatment in the CTCs of the intervention arm , and the other half of whom will be receiving care and /or treatment in the CTCs of the control arm ( 400 children in each condition).We will provide nutrition training to MLPs of the CTCs selected for the intervention arm . In this intervention , we will use the World Health Organization guidelines on nutrition training of health workers for HIV-positive children aged 6 months to 14 years . The trained MLPs will then provide tailored nutrition counseling to caregivers of children being treated at the 8 CTCs of the intervention arm . We will measure nutrition status and child feeding practice s monthly for a total of six months . Conclusions Results of this trial will help exp and ing undernutrition interventions among HIV-positive children in Tanzania and other countries . Trial registration Current Controlled Trials : IS RCT N65346364",
"Background In low-income countries , only about a third of Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome ( HIV/AIDS ) patients eligible for anti-retroviral treatment currently receive it . Providing de central ized treatment close to where patients live is crucial to a faster scale up , however , a key obstacle is limited health system capacity due to a shortage of trained health-care workers and challenges of integrating HIV/AIDS care with other primary care services ( e.g. tuberculosis , malaria , respiratory conditions ) . This study will test an adapted primary care health care worker training and guideline intervention , Practical Approach to Lung Health and HIV/AIDS Malawi ( PALM PLUS ) , on staff retention and satisfaction , and quality of patient care . Methods / Design A cluster-r and omized trial design is being used to compare usual care with a st and ardized clinical guideline and training intervention , PALM PLUS . The intervention targets middle-cadre health care workers ( nurses , clinical officers , medical assistants ) in 30 rural primary care health centres in a single district in Malawi . PALM PLUS is an integrated , symptom-based and user-friendly guideline consistent with Malawian national treatment protocol s. Training is st and ardized and based on an educational outreach approach . Trainers will be front-line peer healthcare workers trained to provide outreach training and support to their fellow front-line healthcare workers during focused ( 1 - 2 hours ) , intermittent , interactive sessions on-site in health centers . Primary outcomes are health care worker retention and satisfaction . Secondary outcomes are clinical outcomes measured at the health centre level for HIV/AIDS , tuberculosis , prevention-of-mother-to-child-transmission of HIV and other primary care conditions . Effect sizes and 95 % confidence intervals for outcomes will be presented . Assessment of outcomes will occur at 1 year post- implementation . Discussion The PALM PLUS trial aims to address a key problem : strengthening middle-cadre health care workers to support the broader scale up of HIV/AIDS services and their integration into primary care . The trial will test whether the PALM PLUS intervention improves staff satisfaction and retention , as well as the quality of patient care , when compared to usual practice .Trial Registration Current controlled Trials : IS RCT",
"Background Antenatal care ( ANC ) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses , and indirectly through the detection of women at increased risk of delivery complications . The potential benefits of quality antenatal care services are most significant in low-re source countries where morbidity and mortality levels among women of reproductive age and neonates are higher . WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal , perinatal and neonatal outcomes . The aim of this study is to determine the effect of an intervention design ed to increase the use of the package of evidence -based services included in the WHO ANC model in Mozambique . The primary hypothesis is that the intervention will increase the use of evidence -based practice s during ANC visits in comparison to the st and ard dissemination channels currently used in the country . Methods This is a demonstration project to be developed through a facility-based cluster r and omized controlled trial with a stepped wedge design . The intervention was tailored , based on formative research findings , to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers . The intervention includes four components : the provision of kits with all necessary medicines and laboratory supplies for ANC ( medical and non-medical equipment ) , a storage system , a tracking system , and training sessions for health care providers . Ten clinics were selected and will start receiving the intervention in a r and om order . Outcomes will be computed at each time point when a new clinic starts the intervention . The primary outcomes are the delivery of selected health care practice s to women attending the first ANC visit , and secondary outcomes are the delivery of selected health care practice s to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practice s. This demonstration project is pragmatic in orientation and will be conducted under routine conditions . Discussion There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-re source countries . This can only be accomplished by the engagement of the country ’s health stakeholders at all levels . This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels : policy , organizational and health care delivery levels . The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in ‘ habits ’ will contribute to obtaining reliable health indicators , not only related to research issues , but also to health care outcomes derived from the new health care model . At policy level , the results of this study may suggest a need for revision of the supply chain management system . Given that supply chain management is a major challenge for many low-re source countries , we envisage that important lessons on how to improve the supply chain in Mozambique and other similar setting s , will be drawn from this study .Trial registration Pan African Clinical Trial Registry data base . Identification number : PACTR201306000550192",
"Background The effects of two interventions , Integrated Management of Infectious Disease ( IMID ) training program and On-Site Support ( OSS ) , were tested on 23 facility performance indicators for emergency triage assessment and treatment ( ETAT ) , malaria , pneumonia , tuberculosis , and HIV . Methods The trial was implemented in 36 primary care facilities in Ug and a. From April 2010 , two mid-level practitioners per facility participated in IMID training . Eighteen of 36 facilities were r and omly assigned to Arm A , and received OSS in 2010 ( nine monthly two-day sessions ) ; 18 facilities assigned to Arm B did not receive OSS in 2010 . Data were collected from Nov 2009 to Dec 2010 using a revised Ministry of Health outpatient medical form and nine registers . We analyzed the effect of IMID training alone by measuring changes before and during IMID training in Arm B , the combined effect of IMID training and OSS by measuring changes in Arm A , and the incremental effect of OSS by comparing changes across Arms A and B. Results IMID training was associated with statistically significant improvement in three indicators : out patients triaged ( adjusted relative risks ( aRR ) = 1.29 , 99%CI = 1.01,1.64 ) , emergency and priority patients admitted , detained , or referred ( aRR = 1.59 , 99%CI = 1.04,2.44 ) , and pneumonia suspects assessed ( aRR = 2.31 , 99%CI = 1.50,3.55 ) . IMID training and OSS combined was associated with improvements in six indicators : three ETAT indicators ( out patients triaged ( aRR = 2.03 , 99%CI = 1.13,3.64 ) , emergency and priority patients admitted , detained or referred ( aRR = 3.03 , 99%CI = 1.40,6.56 ) , and emergency patients receiving at least one appropriate treatment ( aRR = 1.77 , 99%CI = 1.10,2.84 ) ) ; two malaria indicators ( malaria cases receiving appropriate antimalarial ( aRR = 1.50 , 99%CI = 1.04,2.17 ) , and patients with negative malaria test results prescribed antimalarial ( aRR = 0.67 , 99%CI = 0.46,0.97 ) ) ; and enrollment in HIV care ( aRR = 1.58 , 99%CI = 1.32,1.89 ) . OSS was associated with incremental improvement in emergency patients receiving at least one appropriate treatment ( adjusted ratio of RR = 1.84,99%CI = 1.09,3.12 ) . Conclusion The trial showed that the OSS intervention significantly improved performance in one of 23 facility indicators",
"Ensuring the availability of essential drugs and using them appropriately are crucial if limited re sources for health care are to be used optimally . While training of health workers throughout Zimbabwe in drug management ( including stock management and rational drug use ) result ed in significant improvements in a variety of drug use indicators , these achievements could not be sustained , and a new strategy was introduced based on the supervision of primary health care providers . This was launched in 1995 with a training course in supervisory skills for district pharmacy staff . In order to evaluate the impact of the supervision and the effectiveness of the training programme , adherence to st and ard treatment guidelines ( STG ) and stock management protocol s was evaluated in a r and omized controlled trial . The study compared three different groups of health facilities : those that received supervision for either use of STG ( n = 23 ) or stock management ( n = 21 ) - each facility acting as control for the other area of supervision - and a comparison group of facilities which received no supervision ( n = 18 ) . On-the-spot supervision by a specially trained pharmacy staff , based around identified deficiencies , took place at the start of the study and 3 months later . The evaluation compared performance on a variety of drug management indicators at baseline and 6 - 8 months after the second supervisory visit . The results of the study showed that , following supervision , overall stock management improved significantly when compared with the control and comparison groups . Similar improvements were demonstrated for adherence to STG , although the effect was confounded by other interventions . The study also showed that supervision has a positive effect on improving performance in areas other than those supervised , and demonstrated that pharmacy technicians with limited clinical skills can be trained to influence primary health care workers to positively improve prescribing practice s. Allocating re sources to supervision is likely to result in improved performance of health workers with regard to the rational use of essential drugs , result ing in improved efficiency and effectiveness",
"Background The public reporting of health outcomes has become one of the most popular topics and is accepted as a quality improvement method in the healthcare field . However , little research has been conducted on the transparency mechanism , and results are mixed with regard to the evaluation of the effect of public reporting on quality improvement . The objectives of this trial are to investigate the transparency mechanism and to evaluate the effect of public reporting on prescription at the level of individual participants . Methods / Design This study involves a cluster r and omized controlled trial conducted in 20 primary -care facilities ( clusters ) . Eligible clusters are those facilities with excellent hospital information systems and that have agreed to participate in the trial . The 20 clusters are matched into 10 pairs according to Technique for Order Preference by Similarity to Ideal Solution score . As the unit of r and omization , each pair of facilities is assigned at r and om to a control or an intervention group through coin flipping . Prescribed ranking information is publicly reported in the intervention group . The public material s include the posters of individuals and of facilities , the ranking lists of general practitioners , and brochures of patients , which are up date d monthly . The intervention began on 13th November 2013 and lasted for one year . Specifically , participants are surveyed at five points in time ( baseline , quarterly following the intervention ) through question naires , interviews , and observations . These participants include an average of 600 patients , 300 general practitioners , 15 directors , and 6 health bureau administrators . The primary outcomes are the transparency mechanism model and the changes in medicine-prescribe . Subsequently , the modifications in the transparency mechanism constructs are evaluated . The outcomes are measured at the individual participant level , and the professional who analyzes the data is blind to the r and omization status . Discussion This study protocol outlines a design that aims to examine the transparency mechanism and to evaluate the effect of public reporting on prescription . The research design is significant in the field of public policy . Furthermore , this study intends to fill the gap of the investigation of the transparency mechanism and the evaluation of public reporting on prescription",
"SETTING Public sector primary care clinics in Free State Province , South Africa . OBJECTIVES To investigate the effects of on-site in-service clinical skills training for nurse practitioners on tuberculosis ( TB ) treatment outcomes in the same clinics . DESIGN Analysis of TB programme data from clinics taking part in two consecutive r and omised trials of educational outreach aim ed at improving respiratory and human immunodeficiency virus/acquired immune-deficiency syndrome care based on the Practical Approach to Lung Health . We compared treatment outcomes between control and intervention clinics among all patients diagnosed with TB during either trial . RESULTS During the two trials , participating clinics treated 4187 and 2333 TB patients , respectively . Neither intervention was associated with better outcomes overall . However , among retreatment patients , cure or completion rates in intervention clinics were significantly higher during the second trial ( OR 1.78 , 95%CI 1.13 - 2.76 ) . Patients in clinics that had received both interventions had higher cure or completion rates ( OR 1.99 , 95%CI 1.53 - 2.58 ) and lower default rates ( OR 0.25 , 95%CI 0.097 - 0.63 ) than patients in clinics that had received neither intervention . CONCLUSION Although not primarily focused on TB treatment , the interventions appeared to improve successful treatment completion rates among TB retreatment cases . Integrated care programmes support attainment of important TB programme goals",
"Objective A major problem with inappropriate use of antibiotics is the emergence of resistance . Thus , cost-effective interventional strategies are required to improve their use . This study aim ed to evaluate the effect of multifaceted interventions on prescribing practice s of antibiotics in health centers of Khartoum State , Sudan . Methods Twenty health centers were r and omly assigned to receive : ( 1 ) no intervention ; ( 2 ) audit and feedback ; ( 3 ) audit and feedback + seminar ; or ( 4 ) audit and feedback + academic detailing . A total of 1,800 patient encounters , 30 from each health center , were r and omly collected . The total number of encounters with antibiotics prescribed were determined in each health center and they were evaluated with regard to antibiotic choice , dose and duration of therapy before the study and at 1 and 3 months post-intervention . Results In comparison to the control group , the prescriber targeted interventions involving audit and feedback , together with academic detailing ( 4 ) , reduced the mean number of encounters with an antibiotic prescribed by 6.3 and 7.7 ( p mean number of encounters with an inappropriate antibiotic with respect to diagnosis , doses and / or duration of therapy was reduced by 5.3 and 5.9 ( p For audit and feedback together with seminars ( 3 ) and for audit and feedback alone ( 2 ) , the corresponding reductions were 5.3 , 7.1 , 4.4 and 5.1 ( p0.05 ) , respectively . Conclusion Inappropriate prescribing patterns of antibiotics in health centers of Khartoum State , Sudan , are alarmingly high . Multifaceted interventions involving audit and feedback combined with either academic detailing or seminars appear more effective in changing prescribing practice s of antibiotics than audit and feedback alone",
"OBJECTIVES To assess the effect of Integrated Management of Childhood Illness ( IMCI ) relative to routine care on the quality and efficiency of providing care for sick children in first-level health facilities in Tanzania , and to disseminate the results for use in health sector decision-making . DESIGN Non-r and omized controlled trial to compare child health care quality and economic costs in two intervention ( > 90 % of health care workers trained in IMCI ) and two comparison districts in rural Tanzania . PARTICIPANTS For quality measures , all sick children presenting for care at r and om sample s of first-level health facilities ; for costs , all national , district , facility and household costs associated with child health care , taking a societal perspective . RESULTS IMCI training is associated with significantly better child health care in facilities at no additional cost to districts . The cost per child visit managed correctly was lower in IMCI than in routine care setting s : $ 4.02 versus $ 25.70 , respectively , in 1999 US dollars and after st and ardization for variations in population size . CONCLUSION IMCI improved the quality and efficiency of child health care relative to routine child health care in the study districts . Previous study results indicated that the introduction of IMCI in these Tanzanian districts was associated with mortality levels that were 13 % lower than in comparison districts . We can therefore conclude that IMCI is also more cost-effective than routine care for improving child health outcomes . The dissemination strategy for these results led to adoption of IMCI for nationwide implementation within 12 months of study completion",
"The objective of this study was to estimate the caries impact of providing training in infant feeding guidelines to workers at Brazilian public primary care clinics . In a cluster-r and omized controlled trial ( n = 20 clinics ) , health care workers either were trained in guidelines for infant nutrition , stressing healthful complementary feeding , or were assigned to a ‘ usual practice s ’ control , which allowed for maternal counseling at practitioner discretion . Training occurred once ; the amount of counseling provided to mothers was not assessed . Eligible pregnant women were enrolled to follow health outcomes in their children . Early childhood caries ( ECC ) was measured at age three years ( n = 458 children ) . The overall reductions in ECC ( relative risk , 0.92 ; 95%CI , 0.75 , 1.12 ) and severe ECC ( RR , 0.87 ; 95%CI , 0.64 , 1.19 ) were not statistically significant . There was a protective effect among mothers who remained exclusively at the same health center ( S-ECC RR , 0.68 ; 95%CI , 0.47 , 0.99 ) and among those naming the health center as their principal source of feeding advice ( S-ECC RR , 0.53 ; 95%CI , 0.29 , 0.97 ) . Health care worker training did not yield a statistically significant reduction in caries overall , although caries was reduced among children of mothers more connected to their health centers ( Clinical Trials.gov NCT00635453 )",
"BACKGROUND Of the 3.7 million neonatal deaths and 3.3 million stillbirths each year , 98 % occur in developing countries . An evaluation of community-based interventions design ed to reduce the number of these deaths is needed . METHODS With the use of a train-the-trainer model , local instructors trained birth attendants from rural communities in six countries ( Argentina , Democratic Republic of Congo , Guatemala , India , Pakistan , and Zambia ) in the World Health Organization Essential Newborn Care course ( which focuses on routine neonatal care , resuscitation , thermoregulation , breast-feeding , \" kangaroo \" [ skin-to-skin ] care , care of the small baby , and common illnesses ) and ( except in Argentina ) in a modified version of the American Academy of Pediatrics Neonatal Resuscitation Program ( which teaches basic resuscitation in depth ) . The Essential Newborn Care intervention was assessed among 57,643 infants with the use of a before- and -after design . The Neonatal Resuscitation Program intervention was assessed as a cluster-r and omized , controlled trial involving 62,366 infants . The primary outcome was neonatal death in the first 7 days after birth . RESULTS The 7-day follow-up rate was 99.2 % . After birth attendants were trained in the Essential Newborn Care course , there was no significant reduction from baseline in the rate of neonatal death from all causes in the 7 days after birth ( relative risk with training , 0.99 ; 95 % confidence interval [ CI ] , 0.81 to 1.22 ) or in the rate of perinatal death ; there was a significant reduction in the rate of stillbirth ( relative risk with training , 0.69 ; 95 % CI , 0.54 to 0.88 ; P=0.003 ) . In clusters of births in which attendants had been r and omly assigned to receive training in the Neonatal Resuscitation Program , as compared with control clusters , there was no reduction in the rates of neonatal death in the 7 days after birth , stillbirth , or perinatal death . CONCLUSIONS The rate of neonatal death in the 7 days after birth did not decrease after the introduction of Essential Newborn Care training of community-based birth attendants , although the rate of stillbirths was reduced . Subsequent training in the Neonatal Resuscitation Program did not significantly reduce the mortality rates . ( Clinical Trials.gov number , NCT00136708 .",
"Summary Background Although the effectiveness of community mobilisation and promotive care delivered by community health workers in reducing perinatal and neonatal mortality is well established , evidence in support of home-based neonatal resuscitation and infection management is mixed . We assessed the effectiveness of adding training in neonatal bag and mask resuscitation and oral antibiotic therapy for suspected neonatal infections to a basic preventive and promotive interventions package delivered by public sector community-based lady health workers ( LHWs ) in rural Pakistan . Methods We did a cluster-r and omised controlled trial in two subdistricts of Naushahro Feroze in rural Sindh , Pakistan , between April 15 , 2009 , and Dec 10 , 2012 . LHWs , trained in basic newborn resuscitation and in recognition and treatment ( with oral amoxicillin ) of suspected neonatal respiratory infections , were linked with traditional birth attendants and encouraged to attend home births . Control clusters received routine care through the existing national programme . The primary outcome was all-cause neonatal mortality . Independent data collection teams recorded data for all pregnancies and their outcomes , morbidity , mortality , and household practice s related to maternal and newborn care . Findings Of the 27 r and omised clusters with functional LHW programmes , 13 were allocated to the intervention group ( n=242 749 ) and 14 to the control group ( n=256 985 ) . In the intervention group , LHWs did 80 % of the planned community mobilisation sessions , but were able to attend only 1184 ( 14 % ) of 8425 deliveries and 4318 ( 25 % ) of 17 288 neonatal visits within 72 h of birth ( p The neonatal mortality rate was 42 deaths per 1000 livebirths in intervention clusters compared with 55 per 1000 in the control group ( risk ratio 0·80 , 95 % CI 0·68–0·93 ; p=0·005 ) . Interpretation The reduction in neonatal mortality in intervention clusters occurred against a background of improvements in domiciliary practice s for maternal and newborn care . However , the poor reach of LHWs in accessing newborn infants at birth and in the early postnatal period underscores the limitations of tasking community health workers in public sector programmes working in similar circumstances with such complex interventions . Such community-based interventions in health systems should be accompanied by concerted efforts to improve quality of care in facilities and referral systems . Funding Saving Newborn Lives , Save the Children USA",
"BACKGROUND WHO and UNICEF launched the Integrated Management of Childhood Illness ( IMCI ) strategy in the mid-1990s to reduce deaths from diarrhoea , pneumonia , malaria , measles , and malnutrition in children younger than 5 years . We assessed the effect of IMCI on health and nutrition of children younger than 5 years in Bangladesh . METHODS In this cluster r and omised trial , 20 first-level government health facilities in the Matlab subdistrict of Bangladesh and their catchment areas ( total population about 350 000 ) were paired and r and omly assigned to either IMCI ( intervention ; ten clusters ) or usual services ( comparison ; ten clusters ) . All three components of IMCI-health-worker training , health-systems improvements , and family and community activities-were implemented beginning in February , 2002 . Assessment included household and health facility surveys tracking intermediate outputs and outcomes , and nutrition and mortality changes in intervention and comparison areas . Primary endpoint was mortality in children aged between 7 days and 59 months . Analysis was by intention to treat . This study is registered , number IS RCT N52793850 . FINDINGS The yearly rate of mortality reduction in children younger than 5 years ( excluding deaths in first week of life ) was similar in IMCI and comparison areas ( 8.6%vs 7.8 % ) . In the last 2 years of the study , the mortality rate was 13.4 % lower in IMCI than in comparison areas ( 95 % CI -14.2 to 34.3 ) , corresponding to 4.2 fewer deaths per 1000 livebirths ( 95 % CI -4.1 to 12.4 ; p=0.30 ) . Implementation of IMCI led to improved health-worker skills , health-system support , and family and community practice s , translating into increased care-seeking for illnesses . In IMCI areas , more children younger than 6 months were exclusively breastfed ( 76%vs 65 % , difference of differences 10.1 % , 95 % CI 2.65 - 17.62 ) , and prevalence of stunting in children aged 24 - 59 months decreased more rapidly ( difference of differences -7.33 , 95 % CI -13.83 to -0.83 ) than in comparison areas . INTERPRETATION IMCI was associated with positive changes in all input , output , and outcome indicators , including increased exclusive breastfeeding and decreased stunting . However , IMCI implementation had no effect on mortality within the timeframe of the assessment . FUNDING Bill & Melinda Gates Foundation , WHO 's Department of Child and Adolescent Health and Development , and US Agency for International Development",
"In rural Bangladesh , most births take place at home . There is little evidence regarding the influence of traditional birth attendants ( TBAs ) or community volunteers ( CVs ) on early infant feeding practice s. We conducted a pragmatic cluster r and omized controlled trial in Panchagarh District to examine the effects of training and post-training supervision of TBAs/CVs on early breastfeeding practice s. Nine unions were r and omized into three groups of three unions . We compared outcomes between mothers in a control group ( CG ) , those living in unions where TBAs/CVs had received a 5-day training in early feeding practice s ( TG ) and those living in unions where TBAs/CVs were both trained and supervised ( SG ) . A total of 1182 mothers of infants aged 0 - 6 months were interviewed at baseline . After 6 months of intervention , an endline survey was conducted on a different sample of 1148 mothers of infants aged 0 - 6 months in the same areas . In both intervention areas , TBAs/CVs made regular home visits and attended births whenever possible . Rates of early initiation of breastfeeding , avoidance of prelacteal feeds and exclusive breastfeeding were compared between groups using cluster-controlled mixed model logistic regression . At endline , both intervention groups had significantly higher proportions of mothers who reported early initiation of breastfeeding ( CG : 88 % , TG : 96 % , SG : 96 % ) and avoidance of prelacteal feeds ( CG : 48 % , TG : 80 % , SG : 88 % ) compared with the control group ; there were no significant differences between the two intervention groups . The endline rates of reported exclusive breastfeeding were not significantly different among groups ( CG : 67 % , TG : 76 % , SG : 83 % )",
"QUALITY PROBLEM Research in Kenya in the mid-1990s suggested poor quality family planning services and limited access to services . Clinical guidelines for family planning and reproductive health were published in 1991 and up date d in 1997 , but never widely distributed . CHOICE OF SOLUTION Managers and trainers chose intensive , district-level training workshops to disseminate guidelines and up date health workers on guideline content and best practice s. INTERVENTION Training workshops were held in 41 districts in 1999 . Trainees were instructed to up date their untrained co-workers afterwards . As a reinforcement , providers in r and omly selected areas received a ' cascade training package ' of instructional material s and training tips . Providers in 15 r and omly selected clinics also received ' supportive supervision ' visits as a second reinforcement . EVALUATION METHODOLOGY A cluster-r and omized experiment in 72 clinics assessed the overall impact of the training and the marginal benefits of the two reinforcing activities . Research ers and trainers created several dozen indicators of provider knowledge , attitudes , beliefs and practice s. Binomial and multivariate analyses were used to compare changes over time in indicators and in aggregated summary scores . Data from patient interviews were analysed to corroborate provider practice self-reports . Cost data were collected for an economic evaluation . RESULTS Post-test data collected in 2000 showed that quality of care and access increased after the intervention . The cascade training package showed less impact than supportive supervision , but the former was more cost-effective . LESSONS LEARNED Service delivery guidelines , when properly disseminated , can improve family planning practice s in sub-Saharan Africa",
"BACKGROUND China 's national health policy classifies depression as a chronic disease that should be managed in primary care setting s. In some high-income countries use of chronic disease management principles and primary care-based collaborative-care models have improved outcomes for late-life depression ; however , this approach has not yet been tested in China . We aim ed to assess whether use of a collaborative-care depression care management ( DCM ) intervention could improve outcomes for Chinese adults with depression aged 60 years and older . METHODS Between Jan 17 , 2011 , [ corrected ] and Nov 30 , 2013 , we did a cluster-r and omised trial in patients from primary care centre clinics in Shangcheng district of Hangzhou city in eastern China . We r and omly assigned ( 1:1 ) clinics to either DCM ( involving training for physicians in use of treatment guidelines , training for primary care nurses to function as care managers , and consultation with psychiatrists as support ) or to give enhanced care as usual to all eligible patients aged 60 years and older with major depressive disorder . Clinics were chosen r and omly for inclusion from all primary care clinics in the district by computer algorithm and then r and omly allocated depression care interventions remotely by computer algorithm . Physicians , study personnel , and patients were not masked to clinic assignment . Our primary outcome was difference in Hamilton Depression Rating Scale ( HAMD ) score using data for clusters at baseline and 3 , 6 , and 12 month follow-up in a mixed-effects model of the intention-to-treat population . We originally aim ed to analyse outcomes at 24 months , however the difference between groups at 12 months was large and funding was insufficient to continue to 24 months , therefore we decided to end the trial at 12 months . This trial is registered with Clinical Trials.gov , number NCT01287494 . FINDINGS Of 34 primary care clinics in Shangcheng district , 16 were r and omly chosen . We r and omly assigned eight clinics to the DCM intervention ( 164 patients enrolled ) and eight primary care clinics to enhanced care as usual ( 162 patients ) . There were no major differences in baseline demographic and clinical variables between the groups of patients for each intervention . Over the 12 months , patients in clinics assigned to DCM had a significantly greater reduction in HAMD score than did those in practice s assigned to enhanced care as usual ( estimated between group difference -6·5 [ 95 % CI -7·1 to -5·9 ] ; Cohen 's d 0·8 [ 95 % CI 0·8 - 0·9 ] ; p change in HAMD total score was 0·07 ( 95 % CI 0·06 - 0·08 ) . There were no study -related adverse events in either group . INTERPRETATION Clinical outcomes of Chinese adults older than 60 years who had major depression were improved when their primary care clinic used DCM . Primary care-based collaborative management of depression is promising to address this pressing public health need in China . FUNDING National Institutes of Health , Program for New Century Excellent Talents in Universities of China , Ministry of Education , China",
"OBJECTIVES We evaluated an intervention to support health workers after training in Integrated Management of Childhood Illness ( IMCI ) , a strategy that can improve outcomes for children in developing countries by encouraging workers ' use of evidence -based guidelines for managing the leading causes of child mortality . METHODS We conducted a r and omized trial in Benin . We administered a survey in 1999 to assess health care quality before IMCI training . Health workers then received training plus either study supports ( job aids , nonfinancial incentives , and supervision of workers and supervisors ) or usual supports . Follow-up surveys conducted in 2001 to 2004 assessed recommended treatment , recommended or adequate treatment , and an index of overall guideline adherence . RESULTS We analyzed 1244 consultations . Performance improved in both intervention and control groups , with no significant differences between groups . However , training proceeded slowly , and low- quality care from health workers without IMCI training diluted intervention effects . Per- protocol analyses revealed that workers with IMCI training plus study supports provided better care than did those with training plus usual supports ( 27.3 percentage-point difference for recommended treatment ; P IMCI training was useful but insufficient . Relatively inexpensive supports can lead to additional improvements",
"OBJECTIVES To assess the impact of Practical Approach to Lung Health ( PAL ) guidelines on prescription behaviour and the total cost of prescription for patients with asthma , chronic obstructive pulmonary disease and pneumonia . METHODS Pre- and post-intervention comparison in a cluster r and omized trial of primary care facilities . Seven health posts and 33 subhealth posts in Nepal were stratified by type and r and omized into intervention and control groups . Health workers from the intervention facilities received 5 days training on the adapted PAL guidelines and their use . To collect prescription details , we used carbon-copy prescription pads in both groups . To measure the impact of PAL guidelines we used the World Health Organization 's rational use of drug indicators and drug cost indicators , in a multivariate regression analysis . RESULTS The PAL guidelines led to fewer prescriptions of multiple drugs and to more prescriptions of generic and essential drugs . The guidelines also lowered average prescription cost and wastage by disease except for chronic obstructive pulmonary disease although not to a statistically significant degree . Similarly , the prescription of antibiotics and adherence to guidelines improved , albeit not statistically significant . CONCLUSION There is evidence that the implementation of PAL guidelines promotes rational use of drugs for some respiratory diseases . The expected health effects of PAL guidelines should be compared with their implementation costs before continuing training on lung health , and strategies put in place to sustain the effects",
"We outline CONSORT-Equity 2017 reporting st and ards , an extension to the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement that aims to improve the reporting of intervention effects in r and omised trials where health equity is relevant . Health inequities are unfair differences in health that can be avoided by reasonable action . We defined a r and omised trial where health equity is relevant as one that assesses effects on health equity by evaluating an intervention focused on people experiencing social disadvantage or by exploring the difference in the effect of the intervention between two groups ( or as a gradient across more than two groups ) experiencing different levels of social disadvantage , or both . We held a consensus meeting with diverse potential users from high , middle , and low income countries , including knowledge users such as patients and method ologists . We discussed evidence for each proposed extension item from empirical studies , review s , key informant interviews , and an online survey , aim ing to improve clarity of reporting without imposing undue burden on authors . The new guidance contains equity extensions to 16 items from CONSORT 2010 plus one new item on research ethics reporting , with examples of good practice and a brief explanation and elaboration for each . Widespread uptake of this guidance for the reporting of trials where health equity is relevant will make it easier for decision makers to find and use evidence from r and omised trials to reduce unfair inequalities in health",
"Background Effective , scalable strategies to improve maternal , fetal , and newborn health and reduce preventable morbidity and mortality are urgently needed in low- and middle-income countries . Building on the successes of previous checklist-based programs , the World Health Organization ( WHO ) and partners led the development of the Safe Childbirth Checklist ( SCC ) , a 28-item list of evidence -based practice s linked with improved maternal and newborn outcomes . Pilot-testing of the Checklist in Southern India demonstrated dramatic improvements in adherence by health workers to essential childbirth-related practice s ( EBPs ) . The BetterBirth Trial seeks to measure the effectiveness of SCC impact on EBPs , deaths , and complications at a larger scale . Methods / design This matched-pair , cluster-r and omized controlled , adaptive trial will be conducted in 120 facilities across 24 districts in Uttar Pradesh , India . Study sites , identified according to predefined eligibility criteria , were matched by measured covariates before r and omization . The intervention , the SCC embedded in a quality improvement program , consists of leadership engagement , a 2-day educational launch of the SCC , and support through placement of a trained peer “ coach ” to provide supportive supervision and real-time data feedback over an 8-month period with decreasing intensity . A facility-based childbirth quality coordinator is trained and supported to drive sustained behavior change after the BetterBirth team leaves the facility . Study participants are birth attendants and women and their newborns who present to the study facilities for childbirth at 60 intervention and 60 control sites . The primary outcome is a composite measure including maternal death , maternal severe morbidity , stillbirth , and newborn death , occurring within 7 days after birth . The sample size ( n = 171,964 ) was calculated to detect a 15 % reduction in the primary outcome . Adherence by health workers to EBPs will be measured in a subset of births ( n = 6000).The trial will be conducted in close collaboration with key partners including the Governments of India and Uttar Pradesh , the World Health Organization , an expert Scientific Advisory Committee , an experienced local implementing organization ( Population Services International , PSI ) , and frontline facility leaders and workers . Discussion If effective , the WHO Safe Childbirth Checklist program could be a powerful health facility-strengthening intervention to improve quality of care and reduce preventable harm to women and newborns , with millions of potential beneficiaries . Trial registration BetterBirth Study Protocol date d : 13 February 2014 ; Clinical Trials.gov : NCT02148952 ; Universal Trial Number : U1111 - 1131 - 5647"
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This systematic review and meta- analysis of intervention studies aims to evaluate the effect of preoperative and /or post-operative support for adults who elect bariatric surgery delivered by a multidisciplinary team ( MDT ) on post-operative body composition , mental health , co-morbidities , quality of life , and side effects . Six electronic data bases were search ed . Revman and GRADE were used to assess confidence in pooled effects . Included interventions ( N = 1533 participants in total ) focused on lifestyle counselling ( n = 4 studies ) , psychology ( n = 4 studies ) , or exercise ( n = 10 studies ) ; comparator groups were less intensive usual care . Intensive MDT interventions increased post-operative weight loss ( SMD : -0.94 ; 95 % CI : -1.27 to -0.61 ) if delivered post-operatively . Preoperative and post-operative intensive interventions improved symptoms of depression and anxiety , quality of life , diastolic blood pressure , and resting heart rate but not lipids or glycaemic measures . Whilst usual MDT care is important preoperatively , this review conditionally recommends intensive MDT interventions for enhanced post-operative weight loss if delivered in the post-operative period , led by any health professional , based on moderate evidence . This review also conditionally recommends preoperative and /or post-operative lifestyle , nutrition , or psychology counselling and /or physical activity for improved mental and physical health . Further r and omized controlled trials are required , which aim to specifically evaluate the best use of MDT re sources
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"BACKGROUND Bariatric surgery is a powerful treatment of severe obesity . During the past several years , a greater appreciation for the need for multidisciplinary care to optimize outcomes has developed , and a number of studies have been started to examine the role of postoperative interventions used in combination with surgery . The purpose of the present study was to investigate the hypothesis that the provision of postoperative dietary counseling , delivered by a registered dietitian , would lead to greater weight loss and more positive improvements in dietary intake and eating behavior compared with st and ard postoperative care . The study was performed at an academic medical center . METHODS Eighty-four individuals who underwent bariatric surgery were r and omly assigned to receive either dietary counseling or st and ard postoperative care for the first 4 months after surgery . The participants completed measures of macronutrient intake and eating behavior at baseline and 2 , 4 , 6 , 12 , 18 , and 24 months after surgery . RESULTS The patients who received dietary counseling achieved greater weight loss than those who received st and ard postoperative care that did not involve this counseling , although this difference did not reach statistical significance . Patients in the dietary counseling arm did report significant changes in several eating behaviors believed to be important to successful long-term weight maintenance . CONCLUSION The results of our pilot study provide some support for the efficacy of early postoperative dietary counseling to improve outcomes after bariatric surgery",
"ABSTRACT The purpose of this study was to examine the effect of a 12-week resistance training programme on fat-free mass ( FFM ) , muscle cross-sectional area , muscular strength and muscle quality in women who underwent Roux-en-Y gastric bypass surgery . Participants were 16 women ( mean age = 44.9 ± 10.2 years ) from bariatric surgical groups who were r and omly assigned into either a control or an intervention group . Air displacement plethysmography measured FFM and magnetic resonance imaging measured quadriceps muscle cross-sectional area and whole thigh muscle cross-sectional area . Muscular strength and quality was assessed using an estimated 1-Repetition Maximum assessment . All measurements were collected twice , at baseline and at a 12-week follow-up . There were significantly greater improvements in leg press strength ( mean differences = 55.4 % , P ) , leg extension strength ( mean differences = 18.0 % , P = 0.014 , Cohen ’s d = 0.86 ) and leg press muscle quality ( mean differences = 54.5 % , P the resistance training programme . The resistance training intervention significantly improved muscular strength and quality ; however , it did not illicit changes in FFM or muscle cross-sectional area in women who underwent Roux-en-Y gastric bypass surgery",
"OBJECTIVE Bariatric surgery results in significant weight loss and reduces cardiovascular morbidity . However , a large variation in postsurgery weight loss is seen . Physical activity promotes weight loss in nonsurgically treated subjects with obesity . The aim of this study was to investigate the effects of 6 months of supervised physical training following Roux-en-Y gastric bypass surgery ( RYGB ) on body weight and cardiovascular risk markers . METHODS Sixty participants eligible for RYGB were included . Six months post surgery , the participants were r and omly assigned to either twice-weekly supervised physical training sessions in a fitness center ( INT ) or a control group ( CON ) for 26 weeks . Before surgery and 6 , 12 , and 24 months after surgery , the participants underwent an examination program that included anthropometric measurements , blood pressure , heart rate , blood sample s , and an abdominal computed tomography scan . RESULTS RYGB significantly reduced body weight and improved cardiovascular risk markers ( all P physical training intervention result ed in a 4.2-kg ( CI : -0.2 to -8.3 kg ) lower body weight in INT compared with CON at the study end ( P = 0.042 ) . The high-density lipoprotein concentration was significantly higher in INT than in CON at the termination of the intervention , but this was not maintained at the 24-months examination . CONCLUSIONS Physical training following RYGB improves weight loss and cardiovascular health",
" Higher preoperative physical activity ( PA ) strongly predicts higher post-operative PA in bariatric surgery ( BS ) patients , providing rationale for preoperative PA interventions ( PAIs ) . However , whether PAI-related increases can be maintained post-operatively has not been examined . This study compared PA changes across pre- ( baseline , post-intervention ) and post-operative ( 6-month follow up ) periods in participants r and omized to 6 weeks of preoperative PAI or st and ard care control ( SC ) . Of 75 participants initially r and omized , 36 ( PAI n=22 ; SC n=14 ) underwent BS . Changes in daily bout-related ( ⩾10-min bouts ) moderate-to-vigorous PA ( MVPA ) and steps were assessed via the SenseWear Armb and monitor . PAI received weekly counseling to increase walking exercise . Retention ( 86 % ) at post-operative follow up was similar between groups . Intent-to-treat analyses showed that PAI vs SC had greater increases across time ( baseline , post-intervention , follow up ) in bout-related MVPA minutes/day ( 4.3±5.1 , 26.3±21.3 , 28.7±26.3 vs 10.4±22.9 , 11.4±16.0 , 18.5±28.2 ; P=0.013 ) and steps/day ( 5163±2901 , 7950±3286 , 7870±3936 vs 5163±2901 , 5601±3368 , 5087±2603 ; P ) . PAI differed from SC on bout-related MVPA at post-intervention ( P=0.016 ; d=0.91 ) , but not follow up ( P=0.15 ; d=0.41 ) , and steps at post-intervention ( P=0.031 ; d=0.78 ) and follow up ( P=0.024 ; d=0.84 ) . PAI participants maintained preoperative PA increases post-operatively . Findings support preoperative PAIs and research to test whether PA changes can be sustained and influence surgical outcomes beyond the initial post-operative period",
"Importance Bariatric surgery is a life-changing treatment for patients with severe obesity , but little is known about its association with interpersonal relationships . Objectives To investigate if relationship status is altered after bariatric surgery . Design , Setting , and Participants Changes in relationship status after bariatric surgery were examined in 2 cohorts : ( 1 ) the prospect i ve Swedish Obese Subjects ( SOS ) study , which recruited patients undergoing bariatric surgery from September 1 , 1987 , to January 31 , 2001 , and compared their care with usual nonsurgical care in matched obese control participants ; and ( 2 ) participants from the Sc and inavian Obesity Surgery Registry ( SOReg ) , a prospect i ve , electronically captured register that recruited patients from January 2007 through December 2012 and selected comparator participants from the general population matched on age , sex , and place of residence . Data was collected in surgical departments and primary health care centers in Sweden . The current analysis includes data collected up until July 2015 ( SOS ) and December 2012 ( SOReg ) . Data analysis was completed from June 2016 to December 2017 . Main Outcomes and Measures In the SOS study , information on relationship status was obtained from question naires . In the SOReg and general population cohort , information on marriage and divorce was obtained from the Swedish Total Population Registry . Results The SOS study included 1958 patients who had bariatric surgery ( of whom 1389 [ 70.9 % ] were female ) and 1912 matched obese controls ( of whom 1354 [ 70.8 % ] were female ) and had a median ( range ) follow-up of 10 ( 0.5 - 20 ) years . The SOReg cohort included 29 234 patients who had gastric bypass surgery ( of whom 22 131 [ 75.6 % ] were female ) and 283 748 comparators from the general population ( of whom 214 342 [ 75.5 % ] were female ) , and had a median ( range ) follow-up of 2.9 ( 0.003 - 7.0 ) years . In the SOS study , the surgical patients received gastric b and ing ( n = 368 ; 18.8 % ) , vertical b and ed gastroplasty ( n = 1331 ; 68.0 % ) , or gastric bypass ( n = 259 ; 13.2 % ) ; controls received usual obesity care . In SOReg , all 29 234 surgical participants received gastric bypass surgery . In the SOS study , bariatric surgery was associated with increased incidence of divorce/separation compared with controls for those in a relationship ( adjusted hazard ratio [ aHR ] = 1.28 ; 95 % CI , 1.03 - 1.60 ; P = .03 ) and increased incidence of marriage or new relationship ( aHR = 2.03 ; 95 % CI , 1.52 - 2.71 ; P gastric bypass was associated with increased incidence of divorce compared with married control participants ( aHR = 1.41 ; 95 % CI , 1.33 - 1.49 ; P incidence of marriage in those who were unmarried at baseline ( aHR = 1.35 ; 95 % CI , 1.28 - 1.42 ; P changes in relationship status were more common in those with larger weight loss . Conclusions and Relevance In addition to its association with obesity comorbidities , bariatric surgery – induced weight loss is also associated with changes in relationship status",
"Background We have previously reported on the benefits of Pre-Surgical Exercise Training ( PreSET ) on physical fitness and social interactions in subjects awaiting bariatric surgery ( BS ) . However , data are needed to know whether these benefits are maintained post-BS . Objectives The purpose of this paper was to evaluate the effect of PreSET on physical activity ( PA ) level , physical fitness , PA barriers , and quality of life ( QoL ) 1 year ( 1-Y ) after BS . Methods Of the 30 participants r and omized into two groups ( PreSET and usual care ) , 25 were included in the final analysis . One year after BS , time spent in different PA intensities and number of steps were assessed with an accelerometer . Before BS and until 1-Y after BS , physical fitness was assessed with symptom-limited cardiac exercise test , 6-min walk test ( 6MWT ) , and sit-to-st and , half-squat , and arm curl tests . QoL , PA barriers , and PA level were evaluated with question naires . Results The number of steps ( 7460 vs 4287 ) and time spent in light ( 3.2 vs 2.2 h/day ) and moderate ( 0.6 vs 0.3 h/day ) PA were higher in the PreSET group 1-Y after BS . The changes in 6MWT heart cost ( 1.3 vs 0.6 m/beats/min ) , half-squat test ( 38.8 vs 10.3 s ) , and BMI ( − 16.8 vs − 13.5 kg/m2 ) were significantly greater in the PreSET group compared to those in the usual care group . No other significant difference between groups was observed . Conclusion The addition of the PreSET to individual lifestyle counseling seems effective to improve PA level and submaximal physical fitness 1-Y after BS . Studies with larger cohorts are now required to confirm these results .The trial was registered at clinical trials.gov ( NCT01452230 )",
"BACKGROUND AND AIMS Obesity and physical inactivity are both associated with low- grade inflammation and endothelial dysfunction . Bariatric surgery improves markers of inflammation and endothelial function , but it is unknown if physical training after bariatric surgery can improve these markers even further . Therefore , we aim ed to investigate the effects of Roux-en-Y gastric bypass ( RYGB ) followed by physical training on markers of low- grade inflammation and endothelial function . METHODS Sixty patients approved for RYGB underwent examinations pre-surgery , 6 , 12 , and 24 months post-surgery . Six months post-surgery , they were r and omized 1:1 to an intervention group or a control group . The interventions consisted of two weekly sessions of supervised moderate intensity physical training for a period of 26 weeks . Fasting blood sample s were analyzed for concentrations of interleukin 6 ( IL-6 ) , C-reactive protein ( CRP ) , intercellular adhesion molecule 1 ( ICAM-1 ) , tissue-type plasminogen activator antigen ( t-PA : Ag ) and von Willebr and factor ( vWF ) . RESULTS RYGB markedly improved markers of inflammation ( IL-6 , CRP ) ( p endothelial function ( ICAM-1 , t-PA : Ag , vWF ) ( p changes in weight or BMI and the changes in markers of inflammation and endothelial function , except that the change in vWF was found to be inversely correlated with the changes in weight and BMI . We observed no effects of supervised physical training on markers on inflammation or endothelial function ( p>0.1 for all ) . CONCLUSIONS RYGB causes substantial and sustained favorable effects on markers of inflammation and endothelial function . Supervised physical training after RYGB did not cause additional improvements",
"BACKGROUND The Bari-Active trial found that a physical activity ( PA ) intervention ( PAI ) , versus st and ard presurgical care control ( SC ) , produced significant increases in daily bout-related moderate-to-vigorous PA ( MVPA , in≥10-min bouts ) preoperatively . The present study examined whether PAI also produces superior improvements in psychological and /or motivational processes that may be important for PA adoption . OBJECTIVES Compare PAI and SC on baseline to postintervention changes in PA-related enjoyment , self-efficacy , and motivations , and examine whether greater bout-related MVPA changes are associated with greater improvements in these variables . SETTING University hospital , United States . METHODS Participants ( 87 % female ; body mass index = 45.0±6.5 kg/m(2 ) ) were r and omly assigned to 6 weeks of PAI ( n = 40 ) or SC ( n = 35 ) . PAI received weekly counseling sessions to increase daily walking exercise . At baseline and postintervention , both groups completed 7-day objective PA monitoring and question naires to evaluate changes in bout-related MVPA and PA enjoyment , self-efficacy , and motivation . RESULTS Retention was 84 % at postintervention . Intent-to-treat analyses showed that PAI on average reported more favorable changes than SC in PA enjoyment , self-efficacy , amotivation ( i.e. , lack of PA motivation ) , and identified and intrinsic regulations ( i.e. , more autonomous PA motivations ; P , changes in bout-related MVPA and psychological/motivational variables were unrelated . CONCLUSION PAI produced greater improvements in PA-related enjoyment , self-efficacy , and motivations than SC . The lack of association between objective ly measured PA changes and psychological/motivational processes highlights the need for future research to identify which processes are most important for PA adoption and maintenance in bariatric surgery patients , and to determine whether the method used to measure PA affects the pattern of association",
"Objective : To compare bariatric surgery versus intensive medical weight management ( MWM ) in patients with type 2 diabetes mellitus ( T2DM ) who do not meet current National Institutes of Health criteria for bariatric surgery and to assess whether the soluble form of receptor for advanced glycation end products ( sRAGE ) is a biomarker to identify patients most likely to benefit from surgery . Background : There are few studies comparing surgery to MWM for patients with T2DM and BMI less than 35 . Methods : Fifty-seven patients with T2DM and BMI 30 to 35 , who otherwise met the criteria for bariatric surgery were r and omized to MWM versus surgery ( bypass , sleeve or b and , based on patient preference ) . The primary outcomes assessed at 6 months were change in homeostatic model of insulin resistance ( HOMA-IR ) and diabetes remission . Secondary outcomes included changes in HbA1c , weight , and sRAGE . Results : The surgery group had improved HOMA-IR ( −4.6 vs + 1.6 ; P = 0.0004 ) and higher diabetes remission ( 65 % vs 0 % , P lower HbA1c ( 6.2 vs 7.8 , P = 0.002 ) , lower fasting glucose ( 99.5 vs 157 ; P = 0.0068 ) , and fewer T2DM medication requirements ( 20 % vs 88 % ; P lost more weight ( 7 . vs 1.0 BMI decrease , P baseline sRAGE was associated with better weight loss outcomes ( r = −0.641 ; P = 0.046 ) . There were no mortalities . Conclusions : Surgery was very effective short-term in patients with T2DM and BMI 30 to 35 . Baseline sRAGE may predict patients most likely to benefit from surgery . These findings need to be confirmed with larger studies . Clinical Trials.gov ID :",
"Background Many insurance payors m and ate that bariatric surgery c and i date s undergo a medically supervised weight management ( MSWM ) program as a prerequisite for surgery . However , there is little evidence to support this requirement . We evaluated in a r and omized controlled trial the hypothesis that participation in a MSWM program does not predict outcomes after laparoscopic adjustable gastric b and ing ( LAGB ) in a publicly insured population . Methods This pilot r and omized trial was conducted in a large academic urban public hospital . Patients who met NIH consensus criteria for bariatric surgery and whose insurance did not require a m and atory 6-month MSWM program were r and omized to a MSWM program with monthly visits over 6 months ( individual or group ) or usual care for 6 months and then followed for bariatric surgery outcomes postoperatively . Demographics , weight , and patient behavior scores , including patient adherence , eating behavior , patient activation , and physical activity , were collected at baseline and at 6 months ( immediately preoperatively and postoperatively ) . Results A total of 55 patients were enrolled in the study with complete follow-up on 23 patients . Participants r and omized to a MSWM program attended an average of 2 sessions preoperatively . The majority of participants were female and non-Caucasian , mean age was 46 years , average income was less than $ 20,000/year , and most had Medicaid as their primary insurer , consistent with the demographics of the hospital ’s bariatric surgery program . Data analysis included both intention-to-treat and completers ’ analyses . No significant differences in weight loss and most patient behaviors were found between the two groups postoperatively , suggesting that participation in a MSWM program did not improve weight loss outcomes for LAGB . Participation in a MSWM program did appear to have a positive effect on physical activity postoperatively . Conclusion MSWM does not appear to confer additional benefit as compared to the st and ard preoperative bariatric surgery protocol in terms of weight loss and most behavioral outcomes after LAGB in our patient population",
"Background A certain weight gain occurs after obesity surgery compared to the lower weight usually observed between 18 and 24 months postsurgery . The objective of this study was to evaluate weight regain in patients su bmi tted to gastric bypass over a 5-year follow-up period . Material s and Methods A longitudinal prospect i ve study was conducted on 782 obese patients of both genders . Only patients with at least 2 years of surgery were included . The percentage of excess body mass index ( BMI ) loss at 24 , 36 , 48 , and 60 months postsurgery was compared to the measurements obtained at 18 months after surgery . Surgical therapeutic failure was also evaluated . Results Percent excess BMI loss was significant up to 18 months postsurgery ( p Percent BMI loss was no longer significant after 24 months , and weight regain became significant within 48 months after surgery ( p weight regain , a mean 8 % increase was observed within 60 months compared to the lowest weight obtained at 18 months after surgery . The percentage of surgical failure was higher in the superobese group at all times studied , reaching 18.8 % at 48 months after surgery . Conclusion Weight regain was observed within 24 months after surgery in approximately 50 % of patients . Both weight regain and surgical failure were higher in the superobese group . Studies in regard to metabolic and hormonal mechanisms underlying weight regain might eluci date the causes of this finding",
"Objective . To examine whether cognitive behavioral therapy ( CBT ) alleviates dysfunctional eating ( DE ) patterns and symptoms of anxiety and depression in morbidly obese patients planned for bariatric surgery . Design and Methods . A total of 98 ( 68 females ) patients with a mean ( SD ) age of 43 ( 10 ) years and BMI 43.5 ( 4.9 ) kg/m2 were r and omly assigned to a CBT-group or a control group receiving usual care ( i.e. , nutritional support and education ) . The CBT-group received ten weekly intervention sessions . DE , anxiety , and depression were assessed by the TFEQ R-21 and HADS , respectively . Results . Compared with controls , the CBT- patients showed significantly less DE , affective symptoms , and a larger weight loss at follow-up . The effect sizes were large ( DE-cognitive restraint , g = −.92 , P ≤ .001 ; DE-uncontrolled eating , g = −.90 , P ≤ .001 ) , moderate ( HADS-depression , g = −.73 , P ≤ .001 ; DE-emotional eating , g = −.67 , P ≤ .001 ; HADS-anxiety , g = −.62 , P = .003 ) , and low ( BMI , g = −.24 , P = .004 ) . Conclusion . This study supports the use of CBT in helping patients preparing for bariatric surgery to reduce DE and to improve mental health . This clinical trial is registered with NCT01403558",
"BACKGROUND The risk of cardiovascular disease is reduced by bariatric surgery , but it is unknown if exercise after bariatric surgery reduces this risk even further . OBJECTIVE To investigate if Roux-en-Y-gastric bypass ( RYGB ) and supervised physical training after RYGB improve cardiovascular disease risk markers within coagulation activation , fibrin clot properties , and fibrinolysis . SETTING Bariatric center , Hospital of Southwest Jutl and , Denmark . METHODS Sixty obese patients underwent RYGB and 6 months after RYGB were r and omized to 26 weeks of physical training or a control group . Biomarkers within coagulation activation , fibrin clot properties , and fibrinolysis were measured presurgery , and 6 , 12 , and 24 months postsurgery . RESULTS Six months after RYGB , the endogenous thrombin potential decreased from 1744 ( 1603 - 2003 ) to 1416 ( 1276 - 1582 ) nM × min ( P ) . Alterations in fibrin clot properties result ed in an increased clot lysis from 23.8 % ( 16.1%-38.9 % ) to 40.3 % ( 28.5%-59.35 ; P ) . Furthermore , fibrinogen was reduced from 12.6 ( 11.1 - 14.7 ) to 11.5 ( 9.90 - 13.3 ) µM ( P was reduced from 40.5 ( 28.4 - 49.4 ) to 24.4 ( 15.4 - 32.7 ) ng/mL ( P increased fibrinolytic activity from 58.0 ( 36.0 - 75.5 ) to 88.0 ( 66.0 - 132.0 ) IU/mL compared with 52.5 ( 30.0 - 80.0 ) to 64.0 ( 49.0 - 100.0 ) IU/mL in controls ( P reduced plasminogen activator inhibitor antigen from 23.5 ( 16.7 - 35.4 ) to 18.1 ( 14.3 - 25.4 ) ng/mL compared with 24.4 ( 13.9 - 28.7 ) to 24.2 ( 14.1 - 29.6 ) ng/mL in controls ( P effects of physical training were observed on markers of coagulation activation and fibrin clot properties . CONCLUSION We observed favorable long-term reductions in markers of thrombin generation , improved fibrin clot properties , and increases in fibrinolysis after RYGB . Supervised physical training after RYGB further increased fibrinolysis",
"Background The purpose of the present study is to evaluate the impact of a health psychology-led bariatric rehabilitation service ( BRS ) on patient weight loss following bariatric surgery at 1 year . Methods A single-site open-r and omised parallel group control trial based at St. Richard ’s Hospital in Chichester in the UK . Patients ( n = 162 ) were recruited immediately prior to Roux-en-Y gastric bypass and r and omly allocated to receive either treatment as usual ( n = 80 ) or the BRS ( n = 82 ) . The BRS involved three 50-min one-to-one sessions with a health psychologist and provided information , support and mentoring pre and post surgery addressing psychological issues such as dietary control , self esteem , coping and emotional eating . Weight loss was assessed at 1 year . The key outcome variable was BMI and change in BMI . Results Follow-up weight was available for 145 patients . Intention-to-treat analysis ( n = 162 ) using last measured weights showed that mean change in BMI by 1 year post surgery was −16.49 . There was no significant difference between the two groups ( control group = −16.37 , 95 % CI = 15.15–17.57 ; intervention = −16.6 , 95 % CI = 15.42–17.81 ; ηp2 = 0.001 ) . Similarly , explanatory analysis ( n = 145 ) showed a mean change in BMI of −17.17 . The difference between the two groups was not significant ( control group = −16.9 , 95 % CI = 15.78–18.18 ; intervention = −17.35 , 95 % CI = 18.5–16.16 ; ηp2 = 0.001 ) . Conclusions Psychological support pre and post bariatric surgery had no impact on weight loss as measured by BMI and change in BMI by 1 year . It is argued that psychological support should be targeted to patients who start to demonstrate weight regain at a later stage . Trial registration : Clinical Trials.gov NCT01264120",
"Background To examine whether a preoperative cognitive behavioural therapy ( CBT ) intervention exceeds usual care in the improvements of dysfunctional eating behaviours , mood , affective symptoms and body weight 1 year after bariatric surgery . Methods This is a 1-year follow-up of a single centre parallel-group r and omised controlled trial ( http:// clinical trials.gov/ct2/show/NCT01403558 ) . A total of 80 ( 55 females ) patients mean ( SD ) age 44 ( 10 ) years were included . The intervention group received 10 weeks of CBT prior to bariatric surgery , and the control group received nutritional support and education . Both groups were assessed at baseline ( T0 ) , post CBT intervention/preoperatively ( T1 ) , and 1 year postoperatively ( T2 ) . Using a mixed modelling statistical approach , we examined if the CBT group improved more across time than the control group . Results Our hypothesis was not supported as both groups had comparable improvements in all outcomes except for anxiety symptoms . Body weight declined by 30.2 % ( 37.3 kg ) in the CBT group and by 31.2 % ( 40.0 kg ) in the control group from baseline to follow-up , p = 0.82.There were statistically significant reductions in anxiety and depression symptoms in the CBT group between T0 and T1 and between T1 and T2 for depression only . However , in the control group , the anxiety score did not change significantly . The CBT group showed an earlier onset of improvements in all eating behaviours and affective symptoms than the control group . Conclusion The 10-week CBT intervention showed beneficial effects preoperatively , but the non-significant group differences postoperatively indicate a genuine effect of surgery",
"Background Bariatric surgery is currently the most effective form of obesity management for those whose BMI is greater than 40 ( or 35 with co morbidities ) . A minority of patients , however , either do not show the desired loss of excess weight or show weight regain by follow up . Research highlights some of the reasons for this variability , most of which centres on the absence of any psychological support with patients describing how although surgery fixes their body , psychological issues relating to dietary control , self esteem , coping and emotional eating remain neglected . The present study aims to evaluate the impact of a health psychology led bariatric rehabilitation service ( BRS ) on patient health outcomes . The bariatric rehabilitation service will provide information , support and mentoring pre and post surgery and will address psychological issues such as dietary control , self esteem , coping and emotional eating . The package reflects the rehabilitation services now common place for patients post heart attack and stroke which have been shown to improve patient health outcomes . Methods / Design The study is a r and omised control trial and patients will be allocated to receive either usual care or the bariatric rehabilitation service pre and post bariatric surgery . Follow up measures of weight loss and psychological issues will be taken at baseline ( 2 weeks preoperatively ) , 3 , 6 and 12 months postoperatively . The contents of the bariatric service and the follow up measures are based on previous pilot work and have been developed further by the research team working closely with two patient support groups ( BOSPA & WLSinfo ) . This study will take place in St Richard 's Hospital in Chichester in the UK . Discussion It is predicted that a bariatric rehabilitation service will improve weight loss following surgery and will also facilitate changes in other psychological variables such as quality of life , dietary control , self esteem , coping and emotional eating . This also has cost implication s for the NHS and other healthcare providers as improved effectiveness of bariatric surgery reduces the health costs of obese patients in the longer term . Trial registration Clinical Trials.gov NCT01264120",
"OBJECTIVE To document preoperative outcomes of a behavioral lifestyle intervention delivered to patients prior to bariatric surgery in comparison to treatment as usual ( insurance-m and ated physician supervised diet ) . DESIGN AND METHODS After completing a baseline assessment , c and i date s for surgery were r and omized to a 6-month , evidence -informed , manualized lifestyle intervention ( LIFESTYLE , n = 121 ) or to preoperative care as usual ( USUAL CARE , n = 119 ) . At 6 months , 187 participants remained c and i date s for bariatric surgery and were included in the analyses . RESULTS LIFESTYLE participants lost significantly more weight than those receiving USUAL CARE [ 8.3 ± 7.8 kg vs. 3.3 ± 5.5 kg , F(1,183 ) = 23.6 , P logistic regression modeling indicated that LIFESTYLE patients were significantly more likely to lose at least 5 % of initial body weight than those in USUAL CARE [ OR ( 95 % CI ) = 2.94 ( 1.253 , 6.903 ) ] , as were participants who were heavier [ OR ( 95 % CI ) = 1.07 ( 1.001 - 1.14 ) for each unit increase in BMI ] or with larger improvements in eating behaviors [ OR ( 95 % CI ) = 1.1 ( 1.049 , 1.145 ) for each unit increase on the Eating Behavior Inventory ) . CONCLUSIONS A behavioral lifestyle intervention for severely overweight individuals leads to clinical ly significant weight loss prior to bariatric surgery . Post-surgery follow-up will allow us to examine the impact of the preoperative intervention on postoperative outcomes",
"Background Although obesity surgery is currently the most effective method for achieving weight loss , not all patients lose the desired amount of weight and some show weight regain . Previous research shows that successful weight loss may be associated with the amount of investment the patient feels that they have made in their operation . For example , those who feel that it has taken more time and effort to organise , has cost more money , has been more disruptive to their lives and has caused pain are more likely to lose weight after their operation . Therefore , it seems as if the greater the sense of investment , the greater the motivation to make the operation a success . The present study aims to build on these findings by encouraging weight loss surgery patients to focus on the investment they have made , thus making their investment more salient to them and a means to improve weight loss outcomes . Methods The study involves an open r and omised parallel group control trial with patients allocated either to the control or investment intervention group . Using third party blinded r and omization , half the patients will be asked to rate and describe the investment they have made in their operation just before surgery then 3 and 6 months after surgery . All patients will record their weight , beliefs about food , intentions to change and actual eating and exercise behaviour at baseline then 3 , 6 and 12 months follow up . Patients will be recruited from the bariatric surgery pre- assessment clinic at University College Hospital , London . The primary outcome is to explore the impact of the investment based intervention on patient ’s weight and BMI , with secondary outcomes of patients ’ beliefs about foods , behavioural intentions and diet and exercise behaviours . Discussion It is predicted that the investment intervention will improve excess weight loss post-surgery , together with beliefs about food , intentions to change and actual change in diet and exercise behaviour . This has cost implication s for the NHS and other healthcare providers as improved effectiveness of bariatric surgery reduces the health costs of obese patients in the longer term and this simple , easy to administer and low cost intervention could become routine practice for bariatric patients .Trial registration Clinical Trials.gov identifier NCT02045628 ; December 2 , 2013",
"Both Roux-en-Y gastric bypass ( RYGB ) surgery and exercise can improve insulin sensitivity in individuals with severe obesity . However , the impact of RYGB with or without exercise on skeletal muscle mitochondria , intramyocellular lipids , and insulin sensitivity index ( SI ) is unknown . We conducted a r and omized exercise trial in patients ( n = 101 ) who underwent RYGB surgery and completed either a 6-month moderate exercise ( EX ) or a health education control ( CON ) intervention . SI was determined by intravenous glucose tolerance test . Mitochondrial respiration and intramyocellular triglyceride , sphingolipid , and diacylglycerol content were measured in vastus lateralis biopsy specimens . We found that EX provided additional improvements in SI and that only EX improved cardiorespiratory fitness , mitochondrial respiration and enzyme activities , and cardiolipin profile with no change in mitochondrial content . Muscle triglycerides were reduced in type I fibers in CON , and sphingolipids decreased in both groups , with EX showing a further reduction in a number of ceramide species . In conclusion , exercise superimposed on bariatric surgery – induced weight loss enhances mitochondrial respiration , induces cardiolipin remodeling , reduces specific sphingolipids , and provides additional improvements in insulin sensitivity",
"BACKGROUND Preoperative bariatric patients can follow very low calorie diets ( VLCD ) , reducing surgical risks . However , possible advantages of a liquid diet over one of normal consistency are controversial . This study investigated the effect of a liquid VLCD compared with one of normal consistency considering visceral fat ( VF ) loss and metabolic profile in preoperative clinical ly severe obese patients . METHODS This was a r and omized , open-labeled , controlled clinical trial . Patients were divided into 2 groups : liquid diet and normal diet . Data were collected at baseline and 7 and 14 days after intervention . Information gathered was analyzed for loss of weight and VF , biochemical data , anthropometric data , and energy intake . RESULTS Fifty-seven patients consumed the liquid diet and 47 consumed the normal consistency diet . The liquid diet group lost significantly more weight ( P VF ( P VF loss and surgical time among the liquid diet group ( r2=-.1302 , P=.001 ) . Additionally , there was a positive correlation between the percentage of excess weight loss and ketonuria ( P=.0070 ) . No between-group difference occurred regarding calorie intake . CONCLUSION Patients that consumed a liquid diet presented a positive effect on reducing VF and greater weight loss than the normal diet group . Both VLCDs presented benefits offering a protective effect during the preoperative stage",
"Objective Roux-en-Y gastric bypass(RYGB ) can cause profound weight loss and improve overall cardiometabolic risk factors . Exercise ( EX ) training following RYGB can provide additional improvements in insulin sensitivity(SI ) and cardiorespiratory fitness . However , it remains unknown if a specific amount of EX post-RYGB is required to achieve additional benefits . Methods We performed a post-hoc analysis of participants who were r and omized into either a 6-month structured EX program or a health education control ( CON ) . EX(N=56 ) were divided into tertiles according to the amount of weekly exercise performed , compared to CON(N=42 ) : Low-EX=54±8 ; Middle-EX=129±4 ; High-EX=286±40 minutes per week . Results The High-EX lost a significantly greater amount of body weight , total fat mass and abdominal deep subcutaneous abdominal fat compared to CON(p ) . SI improved to a greater extent in both the Middle-EX and High-EX compared to CON(p ) . Physical fitness ( VO2max ) significantly improved in the High-EX(+9.3±4.2 % ) compared to CON(−6.0±2.4%)(p respiration was significantly higher in the High-EX compared to CON . Conclusion A modest volume of structured exercise provides additional improvements in insulin sensitivity following RYGB , but higher volumes of exercise are required to induce additional weight loss , changes in body composition and improvements in cardiorespiratory fitness and skeletal muscle mitochondrial capacity",
"OBJECTIVE To evaluate the effect of 2 post-bariatric support interventions on depressive symptoms of Hispanic Americans treated with gastric bypass for morbid or severe obesity . DESIGN / SETTING Prospect i ve r and omized , controlled trial conducted in a laparoscopic institution . PARTICIPANTS / INTERVENTIONS During the Phase 1 clinical trial ( from preoperative evaluation to 6 months after surgery ) , all participants received st and ard care . During Phase 2 ( 6 - 12 months after surgery ) , participants were r and omly assigned to receive either st and ard care ( n = 72 ) or comprehensive support ( n = 72 ) . Comprehensive group participants received 6 educational sessions focused on behavior change strategies and motivation with nutrition counseling . MAIN OUTCOME MEASURES Depression scores and weight change over time . ANALYSIS Independent sample s t tests and regression analysis assessed relationships among depression scores and excess weight loss . RESULTS Participants receiving behavioral-motivational intervention scored significantly lower on Beck 's Depression Inventory question naire scores than those receiving st and ard care . For those with depressive symptoms at r and omization , 24 % of participants who received the comprehensive intervention reported no depressive symptoms at 12 months after surgery , compared with 6 % of those who received st and ard care ( P depressive mood improvement was significantly and positively associated with excess weight loss and attendance at educational sessions ( P post-bariatric comprehensive behavioral-motivational nutrition education for decreasing risk for depression and improving weight loss",
"BACKGROUND Prior evidence indicates that predictors of weight loss outcomes after gastric bypass surgery fall within 5 domains : 1 ) presurgical factors , 2 ) postsurgical psychosocial variables ( e.g. , support group attendance ) , 3 ) postsurgical eating patterns , 4 ) postsurgical physical activity , and 5 ) follow-up at postsurgical clinic . However , little data exist on which specific behavioral predictors are most associated with successful outcomes ( e.g.,≥ 50 % excess weight loss ) when considering the 5 domains simultaneously . The objective of this study was to specify the behavioral variables , and their respective cutoff points , most associated with successful weight loss outcomes . METHODS Signal detection analysis evaluated associations between 84 pre- and postsurgical behavioral variables ( within the 5 domains ) and successful weight loss at ≥ 1 year in 274 postgastric bypass surgery patients . RESULTS Successful weight loss was highest ( 92.6 % ) among those reporting dietary adherence of>3 on a 9-point scale ( median = 5 ) who grazed no more than once-per-day . Among participants reporting dietary adherence success rates more than doubled when highest lifetime body mass index was . Success rates also doubled for participants with dietary adherence = 3 if attending support groups . No variables from the physical activity or postsurgical follow-up domains were significant , nor were years since surgery . The overall model 's sensitivity = .62 , specificity = .92 . CONCLUSIONS To our knowledge , this is the first study to simultaneously consider the relative contribution of behavioral variables within 5 domains and offer clinicians an assessment algorithm identifying cut-off points for behaviors most associated with successful postsurgical weight loss . Such data may inform prospect i ve study design s and postsurgical interventions",
"BACKGROUND Studies on the impact of presurgery weight loss and lifestyle preparation on outcomes following bariatric surgery are needed . OBJECTIVE To evaluate whether a presurgery behavioral lifestyle intervention improves weight loss through a 24-month postsurgery period . SETTING Bariatric Center of Excellence at a large , urban medical center . METHODS C and i date s for bariatric surgery were r and omized to a 6-month behavioral lifestyle intervention or to 6 months of usual presurgical care . The lifestyle intervention consisted of 8 weekly face-to-face sessions , followed by 16 weeks of face-to-face and telephone sessions before surgery ; the intervention also included 3 monthly telephone contacts after surgery . Assessment s were conducted 6 , 12 , and 24 months after surgery . RESULTS Participants who underwent surgery ( n = 143 ) were 90.2 % female and 86.7 % White . Average age was 44.9 years , and average body mass index was 47.5 kg/m(2 ) at study enrollment . At follow-up , 131 ( 91.6 % ) , 126 ( 88.1 % ) , 117 ( 81.8 % ) patients participated in the 6- , 12- , and 24-month assessment s , respectively . Percent weight loss from study enrollment to 6 and 12 months after surgery was comparable for both groups , but at 24 months after surgery , the lifestyle group had significantly smaller percent weight loss compared with the usual care group ( 26.5 % versus 29.5 % , respectively , P = .02 ) . CONCLUSIONS Presurgery lifestyle intervention did not improve weight loss at 24 months after surgery . The findings from this study raise questions about the utility and timing of adjunctive lifestyle interventions for bariatric surgery patients",
"Background Obesity is a major public health concern on a global scale . Bariatric surgery is among the treatment options , result ing in significant and sustainable weight loss as well as amelioration of comorbidities . The purpose of this study was to evaluate whether a 12-week aerobic exercise program positively impacts heart rate variability ( HRV ) and functional capacity after gastric bypass surgery ( GBS ) in a female cohort . Methods Of the 52 patients initially recruited , 21 were r and omized to a training group ( TG ) or control group and successfully completed the study . Patients were tested on two occasions : 1 week before GBS and 4 months after GBS . Anthropometric variables , body composition , record of heart rate and R-R intervals , and 6-min walk test ( 6MWT ) were assessed at both time points . The TG underwent an aerobic exercise training program on a treadmill ( 1-h session , totaling 36 sessions over 12 weeks ) . Results The main findings from this study were : ( 1 ) only the TG demonstrated a significant increase ( p indexes of heart rate variability ( HRV ) after 12 weeks of aerobic exercise training and ( 2 ) only the TG demonstrated a significant increase ( p 6MWT distance and decrease in diastolic blood pressure after aerobic exercise training . Conclusions We conclude that 12 weeks of aerobic exercise training improves cardiac autonomic modulation and functional capacity 4 months after GBS",
"OBJECTIVE To assess if attendance to a preoperative counseling program improved weight loss or adherence to treatment guidelines in patients who underwent bariatric surgery . METHODS One-hundred-forty-one patients were included in the study . Sixty-nine percent chose to participate in the counseling groups . They were r and omized to a Treatment group and a Control group . Thirty-one percent chose not to participate in the counseling . However , they gave their consent to assessment before and after surgery ( Reference group ) . RESULTS One year after bariatric surgery , 88 % had a weight loss of ≥ 50 % EWL , 37 % reported more than 30 min of physical activity daily , 74 % had 5 - 7 meals daily , and 87 % took recommended vitamins . There were no differences in weight loss , eating habits , or physical exercise between the Treatment group , the Control group and the Reference group one year after surgery . CONCLUSION Preoperative group counseling did not increase treatment adherence to recommended life-style changes . PRACTICE IMPLICATION S In accordance with findings in the present study , it is not reasonable to offer a preoperative counseling program for all patients undergoing bariatric surgery . Further research should focus on developing and evaluating programs for postsurgical follow-up , and identifying patients that are in need for more comprehensive treatment programs",
"OBJECTIVE To test the effectiveness of two levels of physical activity interventions before and up to 6½ months after bariatric surgery . METHODS Before surgery , individuals completed submaximal exercise testing on a treadmill . After r and om assignment to st and ard care , pedometer use , or exercise counseling plus pedometer , participants wore an accelerometer for approximately 2 weeks and returned it to the bariatric center before surgery and 2 , 4 , and 6 months postoperatively . RESULTS Individuals in exercise counseling plus pedometer had higher steps per day and bout minutes of exercise per week than st and ard care and pedometer use over the course of the study . There were no group differences related to exercise tolerance ; however , all groups made significant improvement . There was no statistically significant change in sedentary or light activity nor was there a difference between groups . CONCLUSIONS Exercise counseling using pedometers increases physical activity from the perioperative period to 6½ months after surgery , but providing pedometers without professional feedback may not be more effective than st and ard bariatric surgery treatments . Rapid weight loss increases exercise tolerance and may mask the fitness improvements achieved through a modest physical activity intervention during the first 6 months after bariatric surgery",
"OBJECTIVE To examine the impact of a pre-bariatric surgery physical activity intervention ( PAI ) , design ed to increase bout-related ( ≥10 min ) moderate to vigorous PA ( MVPA ) , on health-related quality of life ( HRQoL ) . METHODS Analyses included 75 adult participants ( 86.7 % female ; BMI = 45.0 ± 6.5 kg m(-2 ) ) who were r and omly assigned to 6 weeks of PAI ( n = 40 ) or st and ard pre-surgical care ( SC ; n = 35 ) . PAI received 6 individual weekly counseling sessions to increase walking exercise . Participants wore an objective PA monitor for 7 days and completed the SF-36 Health Survey at baseline and post-intervention to evaluate bout-related MVPA and HRQoL changes , respectively . RESULTS PAI increased bout-related MVPA from baseline to post-intervention ( 4.4 ± 5.5 to 21.0 ± 21.4 min day(-1 ) ) versus no change ( 7.9 ± 16.6 to 7.6 ± 11.5 min day(-1 ) ) for SC ( P = 0.001 ) . PAI reported greater improvements than SC on all SF-36 physical and mental scales ( P except role-emotional . In PAI , better baseline scores on the physical function and general health scales predicted greater bout-related MVPA increases ( P on the physical function , bodily pain , and general health scales ( P Increasing PA preoperatively improves physical and mental HRQoL in bariatric surgery c and i date s. Future studies should examine whether this effect improves surgical safety , weight loss outcomes , and postoperative",
"BACKGROUND This study examines whether performance of bout-related physical activity ( PA ) during morning hours is related to greater overall bout-related PA increases within a preoperative PA intervention for bariatric surgery ( BS ) patients . METHODS Participants with severe obesity ( n = 33 ; mean age = 45.6 ± 9.6 years ; BMI = 45.7 ± 7.0 kg/m2 ) seeking BS were r and omized to and completed 6 weeks of preoperative PA counseling ( retention = 82.5 % ) . Participants were encouraged to walk daily at a moderate intensity in bouts ≥ 10 minutes during morning hours to overcome time-related obstacles and establish a PA habit . Timing and amount of bout-related moderate-to-vigorous PA ( MVPA ) was assessed via objective monitor at pre- and postintervention . RESULTS Greater proportion of bout-related MVPA performed during morning hours ( 4:00 AM-12:00 PM ) at postintervention was associated with larger total increases in bout-related MVPA minutes/day ( β = .40 , P = .03 ) . At postintervention , a greater proportion of participants whose longest MVPA bouts occurred during morning hours ( n = 11 ) achieved the public health guideline ( ie , ≥150 bout-related MVPA minutes/week ) versus those whose longest MVPA bouts occurred during nonmorning hours ( n = 19 ; 63.6 % vs. 26.3 % , P = .04 ) . CONCLUSIONS Intervention-related increases in PA tended to be greatest when PA was performed in the morning . Morning exercise may be a viable strategy for promoting habitual PA in inactive BS patients",
"Obesity and physical inactivity are major health problems . Roux‐en‐Y gastric bypass ( RYGB ) surgery results in significant weight loss and reduces obesity‐related morbidity and mortality . Physical activity lowers the risk of cardiovascular disease and premature death . The aims of this study were to eluci date the effects of RYGB followed by 6 months of supervised physical training on physical capacity . In a r and omized controlled trial , 60 participants eligible for RYGB were r and omized 6 months post‐surgery to either two weekly physical training sessions for 26 weeks ( INT ) or a control group ( CON ) . Aerobic capacity ( VO2max ) , muscle strength ( MS ) of the shoulder and hip and physical function were measured pre‐surgery and 6 , 12 and 24 months post‐surgery . RYGB per se decreased MS in all tested muscle groups , had no effects on VO2max but improved physical function . After the intervention , INT had a significant 0.33 L min−1 increase in VO2max compared to CON ( 95 % CI : 0.07–0.57 , P = 0.013 ) . Furthermore , MS in the hip adductor increased significantly with 13 N ( 95 % CI : 3.6–22.4 , P = 0.007 ) and a between‐group difference was found in the Stair Climb Test ( 0.46 repetitions [ 95 % CI : 0.02–0.91 , P = 0.042 ] ) . The effects were not maintained at follow‐up . Supervised physical training following RYGB improved VO2max , hip MS and physical function , but the positive effects were not maintained at follow‐up . While activities of daily life may become easier as a result of RYGB , the observed extensive post‐operative loss of MS requires more attention to increase the patient 's physical capacity prospect ively",
"BACKGROUND As morbid obesity increasingly affects Hispanic Americans , the incidence of bariatric procedures among this population is rising . Despite this , prospect i ve research on the effects of comprehensive postoperative education-centered interventions on weight loss and physical activity focused on Hispanic Americans is lacking . OBJECTIVE To examine whether a comprehensive nutrition education and behavior modification intervention improves weight loss and physical activity in Hispanic Americans with obesity following Roux-en-Y gastric bypass surgery ( RYGB ) . METHODS A prospect i ve r and omized-controlled trial was conducted between November 2008 and April 2010 . At 6 months following RYGB , 144 Hispanic Americans with obesity were r and omly assigned to a comprehensive nutrition and lifestyle educational intervention ( n=72 ) or a noncomprehensive approach ( comparison group n=72 ) . Those in the comprehensive group received education sessions every other week for 6 weeks in small groups and frequent contact with a registered dietitian . Those in the comparison group received brief , printed healthy lifestyle guidelines . Patients were reassessed at 12 months following surgery . Main outcome measures were excess weight loss and physical activity changes over time . Statistical analyses used t test , ? ( 2 ) test , Wilcoxon signed rank , Mann-Whitney U test , and intent-to-treat analysis , significance P RESULTS Participants ( mean age 44.5 ± 13.5 years ) were mainly Cuban-born women ( 83.3 % ) . Mean preoperative excess weight and body mass index ( calculated as kg/m(2 ) ) were 72.20 ± 27.81 kg and 49.26 ± 9.06 , respectively . At 12 months following surgery , both groups lost weight significantly , but comprehensive group participants experienced greater excess weight loss ( 80 % vs 64 % from preoperative excess weight ; P and greater body mass index reduction ( 6.48 ± 4.37 vs 3.63 ± 3.41 ; P involved in physical activity ( + 14 min/wk vs ? 4 min/wk ; P participants . Mean protein intake was significantly lower in the comparison group than that in the comprehensive group ( P effective weight reduction in Hispanic Americans following RYGB"
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INTRODUCTION It is not known if statins will improve symptoms in patients with established erectile dysfunction ( ED ) . AIM We carried out a systematic review and meta- analysis to assess the effect of statins on ED . METHODS A literature review was performed to identify all published r and omized double-blind , placebo-controlled trials of statins for the treatment of ED . The search included the following data bases : MEDLINE , Embase , and the Cochrane Controlled Trials Register . The reference lists of the retrieved studies were also investigated . A systematic review and meta- analysis were conducted . MAIN OUTCOME MEASURES Six publications involving a total of 462 patients were used in the analysis , including three r and omized controlled trials ( RCTs ) that compared statins with placebo and three RCTs that compared statins plus sildenafil with placebo plus sildenafil . RESULTS For the comparison of statins ( + /- sildenafil ) with placebo ( + /- sildenafil ) , the mean International Index of Erectile Function ( IIEF-5 ) ( the st and ardized mean difference [ SMD ] = 3.23 , 95 % confidence interval [ CI ] = -1.65 to 4.80 , P statins ( + /- sildenafil ) showed statistically significantly greater improvements in the mean IIEF-5 compared with placebo ( + /- sildenafil ) . For the comparison of statins with placebo , the mean IIEF-5 ( SMD = 2.13 , 95 % CI = -1.46 to 5.73 , P = 0.24 ) indicated that there was no significant difference in erectile function between the statins and placebo . For the comparison of statins plus sildenafil with placebo plus sildenafil , the mean IIEF-5 ( SMD = 3.60 , 95 % CI = 2.64 to 4.56 , P IIEF domain ( SMD = 4.88 , 95%CI = 3.01 to 6.74 , P global efficacy question ( odds ratio = 6.44 , 95 % CI = 2.92 to 14.23 , P placebo plus sildenafil , statins plus sildenafil clearly improved erectile function . CONCLUSIONS This meta- analysis indicates that statins ( + /- sildenafil ) may improve ED compared with placebo ( + /- sildenafil )
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"Cigarette smoking impairs endothelial function . Hydroxymethylglutaryl ( HMG ) CoA reductase inhibitors ( statins ) may favorably affect endothelial function via nonlipid mechanisms . We tested the hypothesis that statins would improve endothelial function independent of changes in lipids in cigarette smokers . Twenty normocholesterolemic cigarette smokers and 20 matched healthy control subjects were r and omized to atorvastatin 40 mg daily or placebo for 4 weeks , washed out for 4 weeks , and then crossed-over to the other treatment . Baseline low-density lipoprotein ( LDL ) levels were similar in smokers and healthy subjects , 103±22 versus 95±27 mg/dL , respectively ( P = NS ) and were reduced similarly in smokers and control subjects by atorvastatin , to 55±30 and 58±20 mg/dL , respectively ( P = NS ) . Vascular ultrasonography was used to determine brachial artery , flow-mediated , endothelium-dependent , and nitroglycerin-mediated , endothelium-independent vasodilation . To eluci date potential molecular mechanisms that may account for changes in endothelial function , skin biopsy specimens were assayed for eNOS mRNA , eNOS activity , and nitrotyrosine . Endothelium-dependent vasodilation was less in smokers than nonsmoking control subjects during placebo treatment , 8.0±0.6 % versus 12.1±1.1 % , ( P=0.003 ) . Atorvastatin increased endothelium-dependent vasodilation in smokers to 10.5±1.3 % ( P=0.017 versus placebo ) but did not change endothelium-dependent vasodilation in control subjects ( to 11.0±0.8 % , P = NS ) . Endothelium-independent vasodilation did not differ between groups during placebo treatment and was not significantly affected by atorvastatin . Multivariate analysis did not demonstrate any association between baseline lipid levels or the change in lipid levels and endothelium-dependent vasodilation . Cutaneous nitrotyrosine levels and skin microvessel eNOS mRNA , but not ENOS activity , were increased in smokers compared with controls but unaffected by atorvastatin treatment . Atorvastatin restores endothelium-dependent vasodilation in normocholesterolemic cigarette smokers independent of changes in lipids . These results are consistent with a lipid-independent vascular benefit of statins but could not be explained by changes in eNOS message and tissue oxidative stress . These findings implicate a potential role for statin therapy to restore endothelial function and thereby investigate vascular disease in cigarette smokers",
"Phosphodiesterase-5 ( PDE-5 ) inhibitors are an effective therapy for the majority of men with erectile dysfunction ( ED ) . However , many men with ED still report a suboptimal or partial response even after an adequate trial of oral PDE-5 therapy . Since ED is associated with impaired vascular function and both atorvastatin and quinapril have been previously shown to improve vascular function , we examined the effects of adjunctive treatment with these medications in men with vasculogenic ED who were suboptimal responders to 100 mg of sildenafil . Men with ED and suboptimal response to sildenafil were r and omly assigned to 3 months of treatment with atorvastatin 40 mg ( n = 12 ) , quinapril 10 mg ( n = 10 ) , or placebo ( n = 13 ) , along with continued adjunctive sildenafil use . Measured variables included : International Index of Erectile Function ( IIEF ) question naire , brachial artery flow-mediated dilation ( FMD ) , endothelium-independent dilation ( EID ) via nitroglycerin , penile Doppler blood flow , blood pressure ( BP ) , lipids , and C-reactive protein ( CRP ) . Compared to placebo , quinapril ( p symptoms of ED as measured by the IIEF-5 question naire . There was a trend toward a significant improvement in IIEF-5 with atorvastatin . Similarly , quinapril significantly improved the IIEF ED Domain ( p peripheral and penile vascular parameters were unchanged with drug therapy as compared to placebo . In conclusion , treatment with quinapril , in combination with sildenafil , improved ED in men with suboptimal response to sildenafil alone . Atorvastatin demonstrated a trend toward improved ED in this group",
"INTRODUCTION Although penile blood flow ( PBF ) has been recommended as an additional diagnostic test in identifying erectile dysfunction ( ED ) patients at risk for latent cardiovascular disease , no study has ever assessed the possible association of PBF and the relational component of sexual function with incident major cardiovascular events ( MACE ) . AIM The aim of this study is to investigate whether severity of ED , PBF , and other factors related to a couple 's relationship predict incident MACE . METHODS A consecutive series of 1,687 patients was studied . Different clinical , biochemical , and instrumental ( penile flow at color Doppler ultrasound ) parameters were evaluated . MAIN OUTCOME MEASURES Information on MACE was obtained through the City of Florence Registry Office . RESULTS During a mean follow-up of 4.3 + /- 2.6 years , 139 MACE , 15 of which were fatal , were observed . Cox regression analysis , after adjustment for age and Chronic Disease Score , showed that severe ED predicted MACE ( hazard ratio [ HR ] 1.75 ; 95 % confidence interval 1.10 - 2.78 ; P risk of MACE ( HR = 2.67 [ 1.42 - 5.04 ] and 1.57 [ 1.01 - 2.47 ] , respectively , for flaccid [ sexual interest in the partner and low sexual interest in the patient proved to have a protective effect against MACE . CONCLUSIONS The investigation of male sexuality , and in particular PBF , and sexual desire , could provide insights not only into present cardiovascular status but also into prospect i ve risk",
"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",
"PURPOSE We estimated the incidence of erectile dysfunction in men 40 to 69 years old at study entry during an average 8.8-year followup , and determined how risk varied with age , socioeconomic status and medical conditions . MATERIAL S AND METHODS Data from a r and omly sample d population based longitudinal study of Massachusetts men were analyzed . A total of 1,709 men completed the baseline interview during 1987 to 1989 and 1,156 survivors completed followup from 1995 to 1997 . The analysis sample consisted of 847 men without erectile dysfunction at baseline and with complete followup information . Erectile dysfunction was assessed by discriminant analysis of 13 questions from a self-administered sexual function question naire and a single global self-rating question . RESULTS The crude incidence rate for erectile dysfunction was 25.9 cases per 1,000 man-years ( 95 % confidence interval [ CI ] 22.5 to 29.9 ) . The annual incidence rate increased with each decade of age and was 12.4 cases per 1,000 man-years ( 95 % CI 9.0 to 16.9 ) , 29.8 ( 24.0 to 37.0 ) and 46.4 ( 36.9 to 58.4 ) for men 40 to 49 , 50 to 59 and 60 to 69 years old , respectively . The age adjusted risk of erectile dysfunction was higher for men with lower education , diabetes , heart disease and hypertension . Population projections for men 40 to 69 years old suggest that 17,781 new cases of erectile dysfunction in Massachusetts and 617,715 in the United States ( white males only ) are expected annually . CONCLUSIONS Although prevalence estimates and cross-sectional correlates of erectile dysfunction have recently been established , incidence estimates were lacking . Incidence is necessary to assess risk , and plan treatment and prevention strategies . The risk of erectile dysfunction was about 26 cases per 1,000 men annually , and increased with age , lower education , diabetes , heart disease and hypertension",
"BACKGROUND Erectile dysfunction ( ED ) may be one manifestation of a generalized vascular disorder characterized by endothelial dysfunction . Statin drugs may improve endothelial function , even before altering the lipid profile . OBJECTIVE We sought to determine whether the addition of a statin with sildenafil would improve ED in men who initially responded poorly to sildenafil . METHODS Men with moderate-to-severe ED despite an adequate sildenafil trial were enrolled in this r and omized , double-blind , placebo-controlled pilot study . ED was defined using a vali date d self-administered question naire as a score of International Index of Erectile Function ( erectile function domain score range of 6 - 30 ) . Improvement in ED score with sildenafil was reassessed at 6 and 12 weeks of treatment with atorvastatin ( 80 mg daily ) or matching placebo . RESULTS Twelve men ( mean age 58 + /- 13 years ) with a mean domain score of 8.2 + /- 6.9 and a mean duration of ED of 3.7 years were enrolled in the study . Treatment with atorvastatin decreased mean low-density lipoprotein cholesterol by 43 % and result ed in an improvement with sildenafil in domain score of 7.8 ( P = 0.036 ) ; an effect was apparent by 6 weeks . The increase in domain score in placebo patients was not statistically significant . CONCLUSIONS Treatment with atorvastatin improved sexual function and the response to oral sildenafil in men who did not initially respond to treatment with sildenafil . The results of this pilot study support the hypothesis that vascular endothelial dysfunction contributes to ED in sildenafil nonresponders and deserves further testing in a large clinical trial",
"The aim of the study is to evaluate the effect of simvastatin in erectile dysfunction ( ED ) secondary to endothelial dysfunction . This study is a double-blind , r and omized , placebo-controlled , clinical trial in patients with ED and endothelial dysfunction . Patients were r and omized to receive 20 mg simvastatin ( n=21 ) or placebo ( n=20 ) daily for 6 months and subsequently 10 mg of vardenafil on dem and for 4 weeks . Serum cholesterol , hormone profile , ultrasensitive C-reactive protein , the International Index of Erectile Dysfunction ( IIEF ) and the ED Index of Treatment Satisfaction were evaluated . There was a significant reduction in serum cholesterol in the treatment group . The hormonal profile remained unaltered . There was no difference in the IIEF between the groups at follow-up , although , at the beginning , 26 % of the patients of both groups presented with mild ED and 74 % with moderate-to-severe ED ; at the end of the 7th month , all patients from the simvastatin group progressed to mild ED , compared with only 83 % in the placebo group . There was no statistically significant difference in penile erection after intake of simvastatin or placebo . This study does not support the use of simvastatin as erectogenic medication . Further studies are necessary to verify if simvastatin has any beneficial effect on ED",
"PURPOSE We prospect ively investigated whether postoperative statin use would contribute to earlier recovery of erectile function in men who underwent bilateral nerve sparing radical retropubic prostatectomy for clinical ly localized prostate cancer . MATERIAL S AND METHODS A total of 50 potent men without hypercholesterolemia undergoing bilateral nerve sparing radical retropubic prostatectomy for clinical ly localized prostate cancer were prospect ively r and omized into 2 equal groups . Group 1 patients were instructed to ingest only 50 mg sildenafil per day if needed following hospital discharge after radical retropubic prostatectomy . Group 2 patients were prescribed atorvastatin at a dose of 10 mg daily from postoperative days 1 to 90 and they were also instructed to ingest sildenafil , as in group 1 . Patient status regarding potency and adverse events were assessed 6 months after surgery . RESULTS The 2 groups demonstrated no significant differences regarding various baseline factors , including International Index of Erectile Function-5 scores . Group 2 had a significantly higher postoperative International Index of Erectile Function-5 score than group 1 at 6 months postoperatively ( p = 0.003 ) . Meanwhile , as judged by a preset definition , the incidence of potent patients 6 months after prostatectomy was 26.1 % in group 1 and 55 % in group 2 ( p = 0.068 ) . Also , 17.4 % and 40 % of the men reported achieving intercourse by vaginal penetration without a phosphodiesterase 5 inhibitor in groups 1 and 2 , respectively ( p = 0.172 ) . No serious adverse events associated with medication were reported . CONCLUSIONS Postoperative treatment with atorvastatin in men who report normal erectile function preoperatively may contribute to earlier recovery of erectile function after nerve sparing radical retropubic prostatectomy",
"Despite the initial enthusiasm , the significant number of patients in whom sildenafil is contraindicated or ineffective is a major challenge to all urologists . Our aim was to determine the safety and efficacy of adjunctive atorvastatin in restoring normal erectile function in hypercholesterolemic ( low-density lipoprotein ( LDL ) cholesterol > 120 mg per 100 ml ) sildenafil nonresponders . The study comprised 131 men with ED not responding to sildenafil citrate . They were r and omized either to 40 mg atorvastatin daily ( n=66 , group 1 ) or matching placebo ( n=65 , group 2 ) for 12 weeks while they were taking on-dem and 100 mg sildenafil . Erectile function was subjectively assessed using the 5-item version of the International Index of Erectile Function ( IIEF-5 ) question naire and response to the global efficacy question ( GEQ ) . Serum biochemical and lipid profile ( total cholesterol , triglycerides , LDL cholesterol and high-density lipoprotein cholesterol ) analyses were performed at baseline and repeated at post-treatment weeks 6 and 12 . Compared with the placebo group ( 59 patients , mean age±s.d . 61.9±6.1 , mean years ED 3.9±1.8 ) , the atorvastatin group ( 59 patients , mean age±s.d . 63.9±6.9 , mean years ED 3.7±1.6 ) had significantly greater improvements in all IIEF-5 questions ( P=0.01 ) and GEQ ( P=0.001 ) . Subgroup analyses did reveal trends in the atorvastatin group to indicate that a change in the IIEF-5 score is affected by age , severity of ED and baseline serum levels of LDL . Patients with moderate ( r=0.28 , P=0.01 ) and severe ( r=0.20 , P=0.01 ) ED had better positive response rates to adjunctive atorvastatin than patients with mild to moderate ED . None of the patients taking atorvastatin achieved a response of 5 to the IIEF-5 questions and none of the patients regained normal erectile function as defined by the IIEF-5 score > 21 . Subjects experienced a statistically significant but modest improvement in erectile function . Further investigation is needed to test the usefulness of long-term atorvastatin administration to restore erectile function in sildenafil nonresponders"
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41172166-06ff-11f0-808a-c43d1ab1c353
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Objectives : Research on labor pain currently uses st and ard scores such as numerical scales as clinical outcomes , but no clear guidelines for such an assessment have appeared since a review published in 1998 . We aim ed to describe and estimate the quality of the methods used to assess and analyze such outcomes in a systematic review of 215 comparative studies published since then in 27 influential journals . Methods : In addition to a complete description , we created for each study a composite “ analysis quality score ” ( AQS ) on the basis of the methods of both measurement of pain/analgesia , and statistical analysis . AQS was tested against various factors , including a “ design quality score ” ( DQS ) , created to estimate method ological quality ( regardless of the analysis of pain intensity ) . Results : Both the AQS and its “ measurement ” component increased with the year of publication , as well as the DQS . The impact factor correlated only with the statistical component of the AQS , and with the DQS . However , the mean AQS and DQS were , respectively , at 43 % and 75 % of their maximal possible value , and these 2 scores were not correlated . The intensity of labor pain ( or pain relief ) was the primary outcome in 19 % of the studies . Although most of the studies actually used numerical scales , the methods of analysis were heterogeneous . When a cutoff point was determined to define analgesia , this was most often 30 % of the maximal value . Discussion : This review points out the need for a better st and ardization of the methods in this field of research
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[
"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",
"Summary A greater variability in a patient 's baseline 7‐day pain rating diary predicts an increased likelihood of placebo group response without affecting the active medication group response . ABSTRACT The degree of variability in the patient baseline 7‐day diary of pain ratings has been hypothesized to have a potential effect on the assay sensitivity of r and omized clinical trials of pain therapies . To address this issue , we obtained clinical trial data from the Food and Drug Administration ( FDA ) through the Analgesic , Anesthetic , and Addiction Clinical Trial Translations , Innovations , Opportunities , and Networks ( ACTTION ) public – private partnership , and harmonized patient level data from 12 clinical trials ( 4 gabapentin and 8 pregabalin ) in postherpetic neuralgia ( PHN ) and painful diabetic peripheral neuropathy ( DPN ) . Models were developed using exploratory logistic regression to examine the interaction between available baseline factors and treatment ( placebo vs active medication ) in predicting patient response to therapy ( ie , > 30 % improvement ) . Our analysis demonstrated an increased likelihood of response in the placebo‐treated group for patients with a higher st and ard deviation in the baseline 7‐day diary without affecting the likelihood of a response in the active medication – treated group , confirming our hypothesis . In addition , there was a small but significant age‐by‐treatment interaction in the PHN model , and small weight‐by‐treatment interaction in the DPN model . The patient 's sex , baseline pain level , and the study protocol had an effect only on the likelihood of response overall . Our results suggest the possibility that , at least in some disease processes , excluding patients with a highly variable baseline 7‐day diary has the potential to improve the assay sensitivity of these analgesic clinical trials , although reductions of external validity must be considered when increasing the homogeneity of the investigated sample",
"OBJECTIVE The goals of this study were to examine agreement and estimate differences in sensitivity between pain assessment scales . DESIGN Multiple simultaneous pain assessment s by patients in acute pain after oral surgery were used to compare a four-category verbal rating scale ( VRS-4 ) and an 11-point numeric rating scale ( NRS-11 ) with a 100-mm visual analog scale ( VAS ) . The sensitivity of the scales ( i.e. , their ability [ power ] to detect differences between treatments ) was compared in a simulation model by sampling from true pairs of observations using varying treatment differences of predetermined size . RESULTS There was considerable variability in VAS scores within each VRS-4 or NRS-11 category both between patients and for repeated measures from the same patient . Simulation experiments showed that the VAS was systematic ally more powerful than the VRS-4 in all simulations performed . The sensitivity of the VAS and NRS-11 was approximately equal . CONCLUSIONS In this acute pain model , the VRS-4 was less sensitive than the VAS . The simulation results demonstrated similar sensitivity of the NRS-11 and VAS when comparing acute postoperative pain intensity . The choice between the VAS and NRS-11 can thus be based on subjective preferences",
"BACKGROUND Assessment s of labour pain focus on pain intensity , not on duration . We aim ed to assess the importance labouring women apply to pain intensity and duration before labour and post-delivery . METHODS Forty healthy women scheduled for labour induction were enrolled in this institutional review board-approved , prospect i ve cohort study . Participants completed a pain preference question naire before active labour and within 24-h of delivery . The question naire consisted of seven stem questions that evaluated preference for pain intensity or duration . The pain preference ratio was determined by dividing the percentage of women who preferred reduced pain intensity for longer duration by that of those who preferred greater pain intensity for shorter duration ( estimate of the odds ) . The overall hypothetical pain burden was determined by multiplying intensity by time . All questions presented the same overall hypothetical pain burden . RESULTS Pain preference question naire scores demonstrated preference for low intensity pain for a longer duration rather than higher intensity for a shorter duration , both pre-labour ( P pain intensity over pain duration ) . This preference for pain duration over intensity was greater post-delivery compared with before labour ( P=0.03 ) . There was a significant correlation ( r=0.83 ; P=0.04 ) between the pain preference ratio vs overall hypothetical pain burden before labour but not after delivery ( r=0.28 ; P=0.59 ) . CONCLUSIONS In this preliminary labour assessment , women preferred lower pain intensity at the cost of longer pain duration . This suggests that pain intensity is the primary driver of hypothetical pain burden-a preference reinforced post-delivery",
"The effects of two different concentrations of epidural levobupivacaine were compared when used to provide analgesia for labour . Primiparous women in spontaneous uncomplicated labour were enrolled in a prospect i ve , r and omised and partially double‐blinded study . The study solutions were either 0.568 mg.ml−1 levobupivacaine ( low concentration group ) or 1.136 mg.ml−1 levobupivacaine ( high concentration group ) , with sufentanil 0.45 μg.ml−1 added to both solutions . Epidural analgesia was initiated with 20 ml of the study solution , followed by a st and ardised algorithm of top‐up bolus injections . Epidural analgesia was then continued by self‐administered boluses of 5‐ml plus a continuous infusion of 5 ml.h−1 . Analgesia was found to be more efficacious in the high‐concentration group . The dose of levobupivacaine administered was higher and sometimes overstepping recommended limits in the high concentration group , but with no observed increase in side‐effects . The choice between these two concentrations may still be made according to the patient ’s and the practitioner ’s preferences . The effects of an intermediate concentration should be studied in the future",
"A verbal numeric 0–10 rating scale ( NRS ) is widely used to evaluate pain in research studies , but its usefulness to the clinician is not well established . In this study , we define desire for additional analgesic medication as a clinical ly relevant outcome in research studies about pain and compare it with the results of the NRS . A post hoc analysis of three studies that we previously conducted concerning labor epidural analgesia was performed . In all three studies , a verbal NRS score was obtained before and 15 min after labor epidural analgesia . At 15 min , the woman was also asked if she wanted more pain medication . We found that very few patients ( 2 % ) with a NRS score of 0–1 wanted more medication . When the NRS score was 2 or 3 , 51 % of the patients wanted more medication , and when the NRS score was > 3 , almost all patients ( 93 % ) wanted more medication . Grouping the final NRS scores into 3 categories ( 0 or 1 , 2 or 3 , and > 3 ) is more useful to the clinician than using individual NRS scores . IMPLICATION S : This study demonstrated that unless the score of the verbal numeric 0–10 rating scale ( NRS ) is 0 or 1 , most women want more analgesic medication for labor epidural analgesia . Additionally , we found that grouping the NRS values into 3 categories for analysis ( 0 or 1 , 2 or 3 , and > 3 ) is more useful to the clinician than using the full spectrum of NRS scores",
"Background The visual analog scale is widely used in research studies , but its connection with clinical experience outside the research setting and the best way to administer the VAS forms are not well established . This study defines changes in dosing of intravenous patient-controlled analgesia as a clinical ly relevant outcome and compares it with VAS measures of postoperative pain . Methods Visual analog scale measurements were obtained from 150 patients on the morning after intraabdominal surgery . On the same afternoon , 50 of the patients provided a VAS score on the same form used in the morning , 50 on a new form , and 50 were not asked for a second VAS measurement . Results Visual analog scale values and changes in value were similar for patients who were given a new VAS form in the afternoon and those who used the form that showed the morning value . The proportions of patients requesting additional analgesia were 4 , 43 , and 80 % , corresponding to afternoon VAS scores of 30 or less , 31–70 , and greater than 70 , respectively . Change from morning VAS score had no apparent influence on patient-controlled analgesic dosing for patients with afternoon values of 30 or less or greater than 70 , but changes in VAS scores of at least 10 did discriminate among patients whose afternoon values were between 31 and 70 . Conclusions When pain is an outcome measure in research studies , grouping final VAS scores into a small number of categories provides greater clinical relevance for comparisons than using the full spectrum of measured values or changes in value . Seeing an earlier VAS form has no apparent influence on later values",
"Summary St and ard tests using individual patient slopes for linear data sets and averaged measures for others are highly sensitive in detecting treatment effects . ABSTRACT Because acute procedural pain tends to increase with procedure time , assessment s of pain management strategies must take that time relationship into account . Statistical time‐course analyses are , however , complex and require large patient numbers to detect differences . The current study evaluated the abilities of various single and simple composite measures such as averaged pain or individual patient pain slopes to detect treatment effects . Secondary analyses were performed with the data from 3 prospect i ve r and omized clinical trials that assessed the effect of a self‐hypnotic relaxation intervention on procedural pain , measured every 10–15 minutes during vascular/renal interventions , breast biopsies , and tumor embolizations . Single point‐in‐time and maximal pain comparisons were poor in detecting treatment effects . Linear data sets of individual patient slopes yielded the same qualitative results as the more complex repeated measures analyses , allowing the use of st and ard statistical approaches ( eg , Kruskal‐Wallis ) , and promising analyses of smaller subgroups , which otherwise would be underpowered . With nonlinear data , a simple averaged score was highly sensitive in detecting differences . Use of these 2 workable and relatively simple approaches may be a first step towards facilitating the development of data sets that could enable meta‐analyses of data from acute pain trials "
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411721ac-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To assess the health benefits of outdoor walking groups . DESIGN Systematic review and meta- analysis of walking group interventions examining differences in commonly used physiological , psychological and well-being outcomes between baseline and intervention end . DATA SOURCES Seven electronic data bases , clinical trial registers , grey literature and reference lists in English language up to November 2013 . ELIGIBILITY CRITERIA Adults , group walking outdoors with outcomes directly attributable to the walking intervention . RESULTS Forty-two studies were identified involving 1843 participants . There is evidence that walking groups have wide-ranging health benefits . Meta- analysis showed statistically significant reductions in mean difference for systolic blood pressure -3.72 mm Hg ( -5.28 to -2.17 ) and diastolic blood pressure -3.14 mm Hg ( -4.15 to -2.13 ) ; resting heart rate -2.88 bpm ( -4.13 to -1.64 ) ; body fat -1.31 % ( -2.10 to -0.52 ) , body mass index -0.71 kg/m(2 ) ( -1.19 to -0.23 ) , total cholesterol -0.11 mmol/L ( -0.22 to -0.01 ) and statistically significant mean increases in VO(2max ) of 2.66 mL/kg/min ( 1.67 - 3.65 ) , the SF-36 ( physical functioning ) score 6.02 ( 0.51 to 11.53 ) and a 6 min walk time of 79.6 m ( 53.37 - 105.84 ) . A st and ardised mean difference showed a reduction in depression scores with an effect size of -0.67 ( -0.97 to -0.38 ) . The evidence was less clear for other outcomes such as waist circumference fasting glucose , SF-36 ( mental health ) and serum lipids such as high-density lipids . There were no notable adverse side effects reported in any of the studies . CONCLUSIONS Walking groups are effective and safe with good adherence and wide-ranging health benefits . They could be a promising intervention as an adjunct to other healthcare or as a proactive health-promoting activity
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[
"Background : Few studies have considered the neighborhood as a context in which to examine the physical activity and quality of life relationship . Purpose : The goal of this study was to evaluate the effects of a neighborhood walking program on quality of life among older adults . It was design ed as a r and omized trial involving a multilevel design with neighborhoods corresponding to primary sampling units and residents to secondary units . Methods : Five hundred eighty-two communitydwelling senior residents ( 65 years of age or older ) in neighborhoods in the northeast metropolitan area of Portl and , Oregon , were recruited through telephone , direct mail , and referrals . The walking intervention was delivered at the neighborhood level . Neighborhoods ( N = 56 ) were r and omly assigned to a 6-month , 3 times per week , leader-led walking group activity ( n = 28 ) or an information-only control group ( n = 28 ) . Primary outcome measures included SF-12 ( Physical , Mental summary scores ) and life satisfaction ( SWLS ) ; the secondary outcome measure was neighborhood walking activity , assessed at baseline , 3 months , and 6 months of the study period . Results : Compared to the control neighborhoods , results from multilevel , longitudinal analyses indicated significant improvements in the primary outcomes of SF-12 Physical ( p SF-12 Mental ( p ( p of walking activity ( p neighborhood-based walking program of low to moderate intensity is feasible and beneficial for promoting quality of life among senior residents at a community level",
"Abstract Introduction Fibromyalgia ( FM ) is characterized by chronic pain . Impaired growth hormone responses and reduced serum insulin-like growth factor 1 ( IGF-1 ) are common in FM . The aim was to examine changes in serum IGF-1 , cerebrospinal fluid ( CSF ) , neuropeptides , and cytokines during aerobic exercise in FM patients . Methods In total , 49 patients ( median age , 52 years ) with FM were included in the study . They were r and omized to either the moderate- to high-intensity Nordic Walking ( NW ) program ( n = 26 ) or the supervised low-intensity walking ( LIW ) program ( n = 23 ) . Patients participated in blood tests before and after 15 weeks of aerobic exercise . Changes in serum levels of free IGF-1 , pain rating on a 0- to 100-mm scale , pain threshold , and 6-minute walk test ( 6MWT ) were examined . CSF , neuropeptides , matrix metalloproteinase 3 ( MMP-3 ) , and inflammatory cytokines were determined . Nonparametric tests were used for group comparisons and correlation analyses . Results Serum free IGF-1 levels did not change during 15 weeks of exercise between the two groups , although the 6MWT significantly improved in the NW group ( p = 0.033 ) when compared with LIW . Pain did not significantly change in any of the groups , but tended to decrease ( p = 0.052 ) over time in the total group . A tendency toward a correlation was noted between baseline IGF-1 and a decrease of pain in response to exercise ( r = 0.278 ; p = 0.059 ) . When adjusted for age , this tendency disappeared . The change in serum free IGF-1 correlated positively with an alteration in CSF substance P ( SP ) levels ( rs= 0.495 ; p = 0.072 ) , neuropeptide Y ( NPY ) ( rs = 0.802 ; p = 0.001 ) , and pain threshold ( rs = 0.276 ; p = 0.058 ) . Differing CSF SP levels correlated positively to a change in pain threshold ( rs= 0.600 ; p = 0.023 ) , whereas the shift in CSF MMP-3 inversely correlated with an altered pain threshold ( rs= -0.569 ; p = 0.034 ) . Conclusions The baseline level of serum free IGF-1 did not change during high or low intensity of aerobic exercise . Changes in IGF-1 correlated positively with a variation in CSF SP , NPY , and pain threshold . These data indicate a beneficial role of IGF-1 during exercise in FM.Trial registration : Clinical Trials.gov NCT00643006",
"Objectives To examine the effect of walking and vitamin B supplementation on quality -of-life ( QoL ) in community-dwelling adults with mild cognitive impairment . Methods One year , double-blind , placebo-controlled trial . Participants were r and omized to : ( 1 ) twice-weekly , group-based , moderate-intensity walking program ( n = 77 ) or a light-intensity placebo activity program ( n = 75 ) ; and ( 2 ) daily vitamin B pills containing 5 mg folic acid , 0.4 mg B12 , 50 mg B6 ( n = 78 ) or placebo pills ( n = 74 ) . QoL was measured at baseline , after six and 12 months using the population -specific Dementia Quality -of-Life ( D-QoL ) to assess overall QoL and the generic Short-Form 12 mental and physical component scales ( SF12-MCS and SF12-PCS ) to assess health-related QoL. Results Baseline levels of QoL were relatively high . Modified intention-to-treat analyses revealed no positive main intervention effect of walking or vitamin supplementation . In both men and women , ratings of D-QoL-belonging and D-QoL-positive affect subscales improved with 0.003 ( P = 0.04 ) and 0.002 points ( P = 0.06 ) with each percent increase in attendance to the walking program . Only in men , SF12-MCS increased with 0.03 points with each percent increase in attendance ( P = 0.08 ) . ConclusionS everal small but significant improvements in QoL were observed with increasing attendance to the walking program . No effect of vitamin B supplementation was observed . Trial Registration International St and ard R and omized Controlled Trial Number Register , 19227688 , http://www.controlled-trials.com/is rct",
"Introduction The objective of this study was to investigate the effects of moderate-to-high intensity Nordic walking ( NW ) on functional capacity and pain in fibromyalgia ( FM ) . Methods A total of 67 women with FM were recruited to the study and r and omized either to moderate-to-high intensity Nordic Walking ( n = 34 , age 48 ± 7.8 years ) or to a control group engaging in supervised low-intensity walking ( LIW , n = 33 , age 50 ± 7.6 years ) . Primary outcomes were the six-minute walk test ( 6MWT ) and the Fibromyalgia Impact Question naire Pain scale ( FIQ Pain ) . Secondary outcomes were : exercise heart rate in a submaximal ergometer bicycle test , the FIQ Physical ( activity limitations ) and the FIQ total score . Results A total of 58 patients completed the post-test . Significantly greater improvement in the 6MWT was found in the NW group ( P = 0.009 ) , as compared with the LIW group . No between-group difference was found for the FIQ Pain ( P = 0.626 ) . A significantly larger decrease in exercise heart rate ( P = 0.020 ) and significantly improved scores on the FIQ Physical ( P = 0.027 ) were found in the NW group as compared with the LIW group . No between-group difference was found for the change in the FIQ total . The effect sizes were moderate for the above mentioned outcomes . Conclusions Moderate-to-high intensity aerobic exercise by means of Nordic walking twice a week for 15 weeks was found to be a feasible mode of exercise , result ing in improved functional capacity and a decreased level of activity limitations . Pain severity did not change over time during the exercise period . Trial registration Clinical trials.gov identifier NCT00643006",
"Objective : To examine the effects of aerobic exercise or vitamin B supplementation on cognitive function in older adults with mild cognitive impairment ( MCI ) . Design : R and omised placebo-controlled trial . Setting : General community . Participants : Community-dwelling adults aged 70–80 with MCI . Interventions : The 152 participants were r and omly assigned to two interventions : ( 1 ) a twice-weekly , group-based , moderate-intensity walking programme ( WP , n = 77 ) or a low-intensity placebo activity programme ( n = 75 ) for one year ; and ( 2 ) daily vitamin pill containing 5 mg folic acid , 0.4 mg vitamin B-12 , 50 mg vitamin B-6 ( FA/B12/B6 , n = 78 ) or placebo pill ( n = 74 ) for one year . Outcome measures : Cognitive function , measured with neuropsychological tests at baseline and after six and 12 months . Results : Median session attendance at the exercise programmes ( 25th–75th percentile ) was 63 % ( 2%–81 % ) and median compliance with taking pills ( 25th–75th percentile ) was 100 % ( 99%–100 % ) . Gender was an effect modifier . Intention-to-treat analysis revealed no main intervention effect for either intervention . In women in the WP , attention ( Stroop combination task ) improved by 0.3 seconds ( p = 0.04 ) and memory ( auditory verbal learning test ) by 0.04 words ( p = 0.06 ) with each percentage increase in session attendance . In men attending at least 75 % of the sessions , the WP improved memory ( β 1.5 ( 95 % CI : 0.1 to 3.0 ) words ) . Conclusion : The walking programme and /or FA/B12/B6 supplementation were not effective in improving cognition within one year . The walking programme , however , was efficacious in improving memory in men and memory and attention in women with better adherence . Trial registration : International St and ard R and omised Controlled Trial Number Register , 19227688 , http://www.controlled-trials.com/is rct",
"Study objective : To compare health walks , a community based lay-led walking scheme versus advice only on physical activity and cardiovascular health status in middle aged adults . Design : R and omised controlled trial with one year follow up . Physical activity was measured by question naire . Other measures included attitudes to exercise , body mass index , cholesterol , aerobic capacity , and blood pressure . Setting : Primary care and community . Participants : 260 men and women aged 40–70 years , taking less than 120 minutes of moderate intensity activity per week . Main results : Seventy three per cent of people completed the trial . Of these , the proportion increasing their activity above 120 minutes of moderate intensity activity per week was 22.6 % in the advice only and 35.7 % in the health walks group at 12 months ( between group difference = 13 % ( 95 % CI 0.003 % to 25.9 % ) p=0.05 ) . Intention to treat analysis , using the last known value for missing cases , demonstrated smaller differences between the groups ( between group difference = 6 % ( 95 % CI −5 % to 16.4 % ) ) with the trend in favour of health walks . There were improvements in the total time spent and number of occasions of moderate intensity activity , and aerobic capacity , but no statistically significant differences between the groups . Other cardiovascular risk factors remained unchanged . Conclusions : There were no significant between group differences in self reported physical activity at 12 month follow up when the analysis was by intention to treat . In people who completed the trial , health walks was more effective than giving advice only in increasing moderate intensity activity above 120 minutes per week ",
"To evaluate the effects of a revised 6‐week walking program for adults with arthritis , Walk With Ease ( WWE ) , delivered in 2 formats , instructor‐led group or self‐directed",
"OBJECTIVES To evaluate and compare the effectiveness and cost-effectiveness of a leisure centre-based exercise programme , an instructor-led walking programme and advice-only in patients referred for exercise by their GPs . DESIGN A single-centre , parallel-group , r and omised controlled trial , consisting of three arms , with the primary comparison at 6 months . SETTING Assessment s were carried out at Copthall Leisure Centre in Barnet , an outer London borough , and exercise programmes conducted there and at three other leisure centres and a variety of locations suitable for supervised walking throughout the borough . PARTICIPANTS Participants were aged between 40 and 74 years , not currently physically active and with at least one cardiovascular risk factor . INTERVENTIONS The 943 patients who agreed to participate in the trial were assessed in cohorts and r and omised to one of the following three arms : a 10-week programme of supervised exercise classes , two to three times a week in a local leisure centre ; a 10-week instructor-led walking programme , two to three times a week ; an advice-only control group who received tailored advice and information on physical activity including information on local exercise facilities . After 6 months the control group were rer and omised to one of the other trial arms . Assessment s took place before r and omisation , at 10 weeks ( in a r and om 50 % sub sample of participants ) , 6 months and 1 year in the leisure centre and walking arms . The control participants were similarly assessed up to 6 months and then reassessed at the same intervals as those initially r and omised to the leisure centre and walking groups . MAIN OUTCOME MEASURES The primary outcome measures were changes in self-reported exercise behaviour , blood pressure , total cholesterol and lipid subfractions . Secondary outcomes included changes in anthropometry , cardiorespiratory fitness , flexibility , strength and power , self-reported lifestyle behaviour , general and psychological health status , quality of life and health service usage . The costs of providing and making use of the service were quantified for economic evaluation . RESULTS There was a net increase in the proportion of participants achieving at least 150 minutes per week of at least moderate activity in the sport/leisure and walking categories in all three study groups : at 6 months , the net increases were 13.8 % in the leisure centre group , 11.1 % in the walking group and 7.5 % in the advice-only group . There were significant reductions in systolic and diastolic blood pressure in all groups at each assessment point compared with baseline . There were also significant and sustained improvements in cardiorespiratory fitness and leg extensor power , and small reductions in total and low-density lipoprotein cholesterol in all groups , but there were no consistent differences between the groups for any parameter over time . All three groups showed improvement in anxiety and mental well-being scores 6 months after the beginning of the trial . Leisure centre and walking groups maintained this improvement at 1 year . There were no differences between groups . Costs to the participants amounted to pound 100 for the leisure centre scheme and pound 84 for the walking scheme , while provider costs were pound 186 and pound 92 , respectively . Changes in overall Short Form 36 scores were small and advice only appeared the most cost-effective intervention . CONCLUSIONS The results of this trial suggest that referral for tailored advice , supported by written material s , including details of locally available facilities , supplemented by detailed assessment s may be effective in increasing physical activity . The inclusion of supervised exercise classes or walks as a formal component of the scheme may not be more effective than the provision of information about their availability . On cost-effectiveness grounds , assessment and advice alone from an exercise specialist may be appropriate to initiate action in the first instance . Subsidised schemes may be best concentrated on patients at higher absolute risk , or with specific conditions for which particular programmes may be beneficial . Walking appears to be as effective as leisure centre classes and is cheaper . Efforts should be directed towards maintenance of increased activity , with proven measures such as telephone support . Further research should include an up date d meta- analysis of published exercise interventions using the st and ardised mean difference approach",
"Objective Swimming is often recommended in the prevention and treatment of hypertension . Few studies have investigated the effect of swimming training on blood pressure ( BP ) . Our objective was to evaluate 6 months of supervised moderate swimming or walking on BP in previously sedentary , normotensive , older women . Design Women aged 50–70 years ( n = 116 ) were r and omly assigned to a supervised 6-month swimming or walking programme . They were further r and omized to receive usual care or a behavioural intervention package . Methods Exercise comprised 3 sessions/week with a warm-up , cool down , and 30-min of moderate intensity walking or swimming . BP was recorded for 20 min supine , and 5 min st and ing . Assessment s were made at 0 and 6 months . Results At baseline , mean supine BP ( ± SD ) was 115.7 ± 1.3/66.8 ± 0.7 mmHg . Swimming improved swim distance by 78.1 m ( 29.3 % ) [ 95 % confidence interval ( CI ) ; 66.7 , 89.4 ] and walk time by 0.58 min ( 3.8 % ) ( 0.41 , 0.74 ) . Walking decreased walk time by 1.0 min ( 6.5 % ) ( 0.81 , 1.19 ) . After adjustment for initial BP , age , hypertension treatment status and change in weight , swimming increased supine and st and ing systolic BP relative to walking by 4.4 mmHg ( 1.2 , 7.5 ) ( P = 0.008 ) and 6.0 mmHg ( 2.6 , 9.5 ) ( P = 0.001 ) , respectively . Supine and st and ing diastolic BP increased by 1.4 mmHg ( −0.14 , 3.0 ) ( P = 0.07 ) and 1.8 mmHg ( −0.02 , 3.5 ) ( P = 0.05 ) , respectively . Conclusion Relative to moderately paced walking , regular swimming significantly elevates BP in previously sedentary , normotensive , older women . This finding may have important implication s for exercise prescription in older subjects",
"Symptoms of Parkinson 's disease ( PD ) progress despite optimized medical treatment . The present study investigated the effects of a flexibility and relaxation programme , walking , and Nordic walking ( NW ) on walking speed , stride length , stride length variability , Parkinson-specific disability ( UPDRS ) , and health-related quality of life ( PDQ 39 ) . 90 PD patients were r and omly allocated to the 3 treatment groups . Patients participated in a 6-month study with 3 exercise sessions per week , each lasting 70 min . Assessment after completion of the training showed that pain was reduced in all groups , and balance and health-related quality of life were improved . Furthermore , walking , and Nordic walking improved stride length , gait variability , maximal walking speed , exercise capacity at submaximal level , and PD disease-specific disability on the UPDRS in addition . Nordic walking was superior to the flexibility and relaxation programme and walking in improving postural stability , stride length , gait pattern and gait variability . No significant injuries occurred during the training . All patients of the Nordic walking group continued Nordic walking after completing the study",
"Background Osteoarthritis ( OA ) is the most common joint disorder in the world , as it is appears to be prevalent among 80 % of individuals over the age of 75 . Although physical activities such as walking have been scientifically proven to improve physical function and arthritic symptoms , individuals with OA tend to adopt a sedentary lifestyle . There is therefore a need to improve knowledge translation in order to influence individuals to adopt effective self-management interventions , such as an adapted walking program . Methods A single-blind , r and omized control trial was conducted . Subjects ( n = 222 ) were r and omized to one of three knowledge translation groups : 1 ) Walking and Behavioural intervention ( WB ) ( 18 males , 57 females ) which included the supervised community-based aerobic walking program combined with a behavioural intervention and an educational pamphlet on the benefits of walking ; 2 ) Walking intervention ( W ) ( 24 males , 57 females ) wherein participants only received the supervised community-based aerobic walking program intervention and the educational pamphlet ; 3 ) Self-directed control ( C ) ( 32 males , 52 females ) wherein participants only received the educational pamphlet . One-way analyses of variance were used to test for differences in quality of life , adherence , confidence , and clinical outcomes among the study groups at each 3 month assessment during the 12-month intervention period and 6-month follow-up period . Results The clinical and quality of life outcomes improved among participants in each of the three comparative groups . However , there were few statistically significant differences observed for quality of life and clinical outcomes at long-term measurements at 12-months end of intervention and at 6- months post intervention ( 18-month follow-up ) . Outcome results varied among the three groups . Conclusion The three groups were equivalent when determining the effectiveness of knowledge uptake and improvements in quality of life and other clinical outcomes . OA can be managed through the implementation of a proven effective walking program in existing community-based walking clubs . Trial registration Current Controlled Trials",
"OBJECTIVE To evaluate the impact of an exercise program organized into supervised walking groups in subjects with type 2 diabetes . RESEARCH DESIGN AND METHODS Fifty-nine diabetic subjects were r and omized to a control group receiving st and ard lifestyle recommendations or an intervention group assigned to three supervised walking sessions per week and counseling . Changes in metabolic features , weight , 6-min walk test , prescription of antidiabetic medications , and overall physical activity were assessed . RESULTS Functional capacity and overall physical activity were higher in the intervention group , whereas metabolic changes were not different between groups after 4 months . However , in subjects who attended at least 50 % of scheduled walking sessions , changes in A1C and fasting glucose were greater than in control subjects . Discontinuation or reduction of antidiabetic drugs occurred in 33 % of these patients versus 5 % of control subjects ( P Supervised walking may be beneficial in diabetic subjects , but metabolic improvement requires adequate compliance",
"BACKGROUND Physical activity has demonstrated efficacy in depression and anxiety , but its potential in the management of bipolar disorder is yet unexplored . This study is a pilot investigation into the effectiveness of an adjunctive walking program in the acute treatment of bipolar disorder . METHODS This is a retrospective cohort study of all patients admitted over a 24-month period to a private psychiatric unit with a primary diagnosis of bipolar disorder ( ICD-10 ) . All patients were invited to participate voluntarily in a walking group during their admissions . Those who reliably attended the walking group ( participants ) were compared against those who did not attend ( non- participants ) , using the clinician-rated Clinical Global Impression Severity ( CGI-S ) and Improvement ( CGI-I ) scales and the self-reported 21-item Depression Anxiety Stress Scales ( DASS ) as primary outcome measures . RESULTS There were 24 admissions for participants and 74 admissions for non- participants . The two groups did not differ significantly in patient demographics or admission CGI and DASS measures , except for a lower DASS Stress subscore for participants ( p=0.049 ) . At discharge , the inter-group differences in CGI measures remained non-significant , but participants had significantly lower scores than non- participants for DASS ( p=0.005 ) and all its subscales ( Depression p=0.048 , Anxiety p=0.002 , Stress p=0.01 ) . LIMITATIONS Method ological limitations include a retrospective design , small sample size , lack of r and omisation or control , and indirect measure of manic symptoms . CONCLUSIONS The results of this trial provide preliminary support for a therapeutic role of physical activity in bipolar disorder , and warrant further investigation with r and omised controlled trials",
"In order to assess the effects of regular walking on metabolic control and cardiovascular risk factors in type 2 diabetes 26 patients from one primary care clinic , aged 60.0+/-7.3 years , participated in a walking program during 4 months . Prescribed exercise was walking for 45 - 60 min three times weekly . A control group of 26 patients from a neighboring primary care clinic , aged 59.3+/-6.2 years , received no exercise instructions . Thus , r and omization was not performed . There were no improvements of blood pressure , body mass index , physical fitness , glycated hemoglobin A1c , fasting plasma glucose or insulin by intention-to-treat analysis . Seventeen patients in the intervention group increased their physical activity and improved systolic blood pressure ; -7.6 mmHg ( -15 to -0.2 ) , diastolic blood pressure ; -4.3 mmHg ( -7.4 to -1.2 ) , body mass index ; -0.6 kg/m2 ( -1.1 to -0.1 ) and total plasma cholesterol ; -0.6 mmol/l ( -0.9 to -0.3 ) , ( mean difference , with 95 % CI ) . We could observe no effects on glucose metabolism in either group . Our results suggest that an increase of regular physical activity equivalent to 45 min of walking 3 days/week may suffice to improve systolic and diastolic blood pressure , lipid metabolism and BMI in patients with type 2 diabetes",
"The purpose of the research project was to examine the effects of exercise , social support and depression on postnatal women who reported experiencing postnatal depression . A 12-week r and omized , controlled trial was conducted investigating the effects of an exercise intervention group ( a pram-walking programme for mothers and their babies ) compared to a social support group ( non-structured sessions , similar to a playgroup ) . Participants in both groups had given birth in the past 12 months . Pretest data of physical fitness and structured question naires were compared to post-test effects . The primary outcomes were to reduce the depressive symptomatology and improve fitness levels of participants in the pram-walking group . Secondary outcomes were to improve the social support levels of the participants in both groups and explore women 's views about the programmes . It was hypothesized that the pram-walking group participants would improve their feelings of depression and fitness levels compared to the social support group , but that both groups would improve their perceived levels of social support . The results showed that mothers in the pram-walking intervention group improved their fitness levels and reduced their level of depressive symptomatology significantly more than the social support group . There were no significant changes to social support levels for both groups . Therefore , a direct association between improvement in fitness was related to improvement in depression for the pram-walking group . However , it is also suggested that other factors in combination with improvements in fitness influenced improvements in depression levels . It is recommended that pram-walking programmes for mothers with postnatal depression be implemented as pilot research into existing available services",
"OBJECTIVES To estimate the impact of small reductions in the population distribution of diastolic blood pressure ( DBP ) , such as those potentially achievable by population -wide lifestyle modification , on incidence of coronary heart disease ( CHD ) and stroke . DESIGN Published data from the Framingham Heart Study , a longitudinal cohort study , and from the National Health and Nutrition Examination Survey II , a national population survey , were used to examine the impact of a population -wide strategy aim ed at reducing DBP by an average of 2 mm Hg in a population including normotensive subjects . SETTING / PARTICIPANTS White men and women aged 35 to 64 years in the United States . MAIN OUTCOME MEASURES Incidence of CHD and stroke , including transient ischemic attacks ( TIAs ) . RESULTS Data from overviews of observational studies and r and omized trials suggest that a 2-mm Hg reduction in DBP would result in a 17 % decrease in the prevalence of hypertension as well as a 6 % reduction in the risk of CHD and a 15 % reduction in risk of stroke and TIAs . From an application of these results to US white men and women aged 35 to 64 years , it is estimated that a successful population intervention alone could reduce CHD incidence more than could medical treatment for all those with a DBP of 95 mm Hg or higher . It could prevent 84 % of the number prevented by medical treatment for all those with a DBP of 90 mm Hg or higher . For stroke ( including TIAs ) , a population -wide 2-mm Hg reduction could prevent 93 % of events prevented by medical treatment for those with a DBP of 95 mm Hg or higher and 69 % of events for treatment for those with a DBP of 90 mm Hg or higher . A combination strategy of both a population reduction in DBP and targeted medical intervention is most effective and could double or triple the impact of medical treatment alone . Adding a population -based intervention to existing levels of hypertension treatment could prevent an estimated additional 67,000 CHD events ( 6 % ) and 34,000 stroke and TIA events ( 13 % ) annually among all those aged 35 to 64 years in the United States . CONCLUSIONS A small reduction of 2 mm Hg in DBP in the mean of the population distribution , in addition to medical treatment , could have a great public health impact on the number of CHD and stroke events prevented . Whether such DBP reductions can be achieved in the population through lifestyle interventions , in particular through sodium reduction , depends on the results of ongoing primary prevention trials as well as the cooperation of the food industry , government agencies , and health education professionals",
"Few controlled studies describe the psychological effects of a walking program on non clinical , premenopausal women . This experiment measured the effects of an 8–wk . walking program on female volunteers ( N = 27 ) age 29 to 50 years ( M = 37.4 ) r and omly assigned to a supervised walking group vs a nonwalking group . A repeated- measures , multivariate design was used to analyze blood pressure , resting heart rate , timed mile walk , and scores on self-esteem , depression , and attributional style . The walking group showed significant improvement in the timed mile walk , diastolic blood pressure , and rated self-esteem",
"BACKGROUND Information is lacking about the physiological and psychosocial effects of exercise among very old persons . AIM To investigate the effect of a twice-weekly , six-month progressive walking programme on 38 healthy women in their ninth decade , for evidence of the benefits of exercise . METHODS Aerobic fitness , blood pressure , skinfold thickness and habitual activity patterns were studied in a r and omised controlled trial . Women were chosen , as this is a group of increasing demographic importance for which studies are lacking . RESULTS The training group and control group were not significantly different at baseline . However , after six months of progressive exercise the training group showed lower resting ( p working ( p heart rates compared with non-exercising controls . ANCOVA analyses indicated higher scores for the training group compared with the control group for Maximum Current Activity and Normative Impairment Index ( both p Morale also significantly improved within the training group ( p very old women and the positive impact a low frequency , progressive exercise programme can have on cardiorespiratory fitness and daily living activity patterns . Such improvements are likely to be indicative of an enhanced outlook for independence",
"BACKGROUND Over the last 10 years ' exercise referral schemes ' have been popular even though the evidence for effectiveness of any one-to-one intervention in primary care is deficient . We report the results of a primary care based one-to-one intervention that compared the effect of two communication styles with a no-intervention control group on self-reported physical activity at 12 months . METHODS In all , 1658 middle-aged men and women were r and omly assigned to 30 minutes of brief negotiation or direct advice in primary care or a no-intervention control group . The main outcome was self-reported physical activity at 12 months . Secondary outcome measures included change in blood pressure and body mass index . RESULTS Intention-to-treat analysis revealed no significant differences in physical activity between groups . Brief negotiation group participants who completed the study increased their physical activity significantly more than controls . There was no change in body mass index in any group . The brief negotiation group produced a greater reduction in diastolic blood pressure than direct advice . CONCLUSION If patients whose health may benefit from increased physical activity seek advice in primary care , 20 - 30 minutes of brief negotiation to increase physical activity is probably more effective than similar attempts to persuade or coerce . However , blanket physical activity promotion in primary care is not effective . The most effective way of increasing physical activity in primary care has yet to be determined",
"The purpose of this study was to evaluate and compare the effectiveness of muscle-strengthening exercises ( MS ) and a walking program ( WA ) in reducing pain in patients with fibromyalgia . Ninety women , 30–55 years of age , diagnosed with fibromyalgia according to the American College of Rheumatology 1990 criteria , were r and omized into 3 groups : WA Group , MS Group , and control group . Pain ( visual analog scale ) was evaluated as the primary outcome . Physical functioning ( Fibromyalgia Impact Question naire , FIQ ) , health-related quality of life ( Short-Form 36 Health Survey , SF-36 ) , and use of medication were evaluated as secondary outcomes . Assessment s were performed at baseline , 8 , 16 , and 28 weeks . Intention-to-treat and efficacy analyses were conducted . Sixty-eight patients completed the treatment protocol . All 3 groups showed improvement after the 16-week treatment compared to baseline . At the 28-week follow-up , pain reduction was similar for the WA and MS groups ( P = 0.39 ) , but different from the control group ( P = 0.01 ) . At the end of the treatment , 80 % of subjects in the control group took pain medication , but only 46.7 % in the WA and 41.4 % in the MS groups . Mean FIQ total scores were lower for the WA and MS groups ( P = 0.96 ) compared with the control group ( P the WA and MS groups reported higher scores ( better health status ) than controls in almost all SF-36 subscales . MS was as effective as WA in reducing pain regarding all study variables ; however , symptoms management during the follow-up period was more efficient in the WA group",
"OBJECTIVE We studied whether the quantity and quality of walking necessary to decrease the risk of cardiovascular disease among women differed substantially from that required to improve cardiorespiratory fitness . DESIGN A r and omized , controlled , dose-response clinical trial with a follow-up of 24 weeks . SETTING A private , nonprofit biomedical research facility . PARTICIPANTS One hundred two sedentary premenopausal women , 20 to 40 years of age , were r and omized to one of four treatment groups ; 59 completed the study ( 16 aerobic walkers [ 8.0-km/h group ] , 12 brisk walkers [ 6.4-km/h group ] , 18 strollers [ 4.8-km/h group ] , and 13 sedentary controls ) . Eighty-one percent were white , 17 % black , and 2 % Hispanic . INTERVENTION Intervention groups walked 4.8 km per day , 5 days per week at 8.0 km/h , 6.4 km/h , or 4.8 km/h on a tartan-surfaced , 1.6-km track for 24 weeks . MAIN OUTCOME MEASURES Fitness ( determined by maximal oxygen uptake ) and cardiovascular risk factors ( determined by resting blood pressure and serum lipid and lipoprotein levels ) . RESULTS As compared with controls , maximal oxygen uptake increased significantly ( P less than .0001 ) and in a dose-response manner ( aerobic walkers greater than brisk walkers greater than strollers ) . In contrast , high-density lipoprotein cholesterol concentrations were not dose related and increased significantly ( P less than .05 ) and to the same extent among women who experienced considerable improvements in their physical fitness ( 8.0-km/h group , + 0.08 mmol/L ) and those who had only minimal improvements in fitness ( 4.8-km/h group , + 0.08 mmol/L ) . High-density lipoprotein cholesterol also increased among the 6.4-km/h group , but did not attain statistical significance ( + 0.06 mmol/L ; P = .06 ) . Dietary patterns revealed no significant differences among groups . CONCLUSION Thus , we conclude that vigorous exercise is not necessary for women to obtain meaningful improvements in their lipoprotein profile . Walking at intensities that do not have a major impact on cardiorespiratory fitness may nonetheless produce equally favorable changes in the cardiovascular risk profile",
"Few prospect i ve studies have been conducted with women to examine the effects of walking on body composition and serum lipid profiles . Overweight women were r and omly assigned to either an exercise EX ( no. 18 ) or a nonexercise NEX ( no. 18 ) group . The EX group participated in five 45 min sessions/week of brisk walking at 62 + /- 2 % VO2max for 15 weeks . Statistical analysis ( 2 x 3 repeated measures ANOVA ) revealed that the pattern of change in total body weight [ F(2.68 ) = 6.65 , p = 0.002 ] but not body fat percentage , was significantly different between EX and NEX groups ; NEX subjects had a 1.6 + /- 0.5 kg gain in contrast to no change in EX subjects . The pattern of change in serum triglycerides , total cholesterol , and LDL-C was not significantly different between groups . The interaction statistic for HDL-C , however , was significant [ Pillais Trace ( 2.33 ) = 3.73 , p = 0.035 ] with HDL-C tending to rise in the NEX group in contrast to a small decrease in the EX group . Change in kilocalorie intake was positively correlated with change in HDL-C , total cholesterol , and body weight . Change in body weight also correlated positively with change in HDL-C. Our findings suggest that moderate exercise training alone may not be a sufficient stimulus to affect body composition and serum lipid profiles favorably in overweight women",
"Purpose : To describe the population in terms of risk for disability and compare the effects of a walking intervention and nutrition education intervention on risk modification and functional performance in lower socioeconomic older adults using a r and omized controlled study . Methods : Twenty‐six community‐dwelling older adults aged 60 and older were r and omly assigned to a 16‐week walking exercise group or a nutrition education control group . Peak aerobic capacity and physical function were measured at baseline and post intervention . Physical function was measured using the Medical Outcomes Study Short Form Health Survey Physical Function subscale , Short Physical Performance Battery , Physical Performance Test , and Continuous Scale Physical Functional Performance 10 item test ( CS‐PFP10 ) . Results : Eighty‐five percent of the participants were at risk for pre clinical disability of which 50 % were at risk for moderate disability . The walking exercise group significantly improved in peak aerobic capacity ( 18.9 % ) , physical function ( 25 % ) using the CS‐PFP10 compared to the control group . Conclusion : These findings highlight the importance of physical activity and indicate that walking , a simple exercise that can be done without specialized exercise leader or equipment can significantly increase peak aerobic capacity and physical function in just 4 months"
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Background The aim of this study was to systematic ally review the content validity and measurement properties of all physical function ( PF ) scales which are currently vali date d for use with patients with rheumatoid arthritis ( RA ) . Methods Systematic literature search es were performed in the Scopus and PubMed data bases to identify articles on the development or psychometric evaluation of PF scales for patients with RA . The content validity of included scales was evaluated by linking their items to the International Classification of Functioning Disability and Health ( ICF ) . Furthermore , available evidence of the reliability , validity , responsiveness , and interpretability of the included scales was rated according to published quality criteria . Results The search identified 26 question naires with PF scales . Ten question naires were rated to have adequate content validity . Construct validity , internal consistency , test-retest reliability and responsiveness was rated favourably for respectively 15 , 11 , 5 , and 6 of the investigated scales . Information about the absolute measurement error and minimal important change scores were rarely reported . Conclusion Based on this literature review , the disease-specificHAQ and the generic SF-36 can currently be most confidently recommended to measure PF in RA for most research purpose s. The HAQ , however , was frequently associated with considerable ceiling effects while the SF-36 has limited content coverage . Alternative scales that might be better suited for specific research purpose s are identified along with future directions for research
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"Health status measures are conceptually relevant to the assessment of clinical outcome in the rheumatic diseases , but their ability to detect meaningful changes in health has not been clearly demonstrated . This report describes the performance of a self-administered health status question naire in a r and omized , double-blind , 21-week comparison of placebo , oral gold , and injectable gold in rheumatoid arthritis patients . Outcome was assessed by st and ard clinical measures , including joint count , grip strength , and laboratory tests , and by the Arthritis Impact Measurement Scales , a reliable and valid health status measure that assesses physical disability , psychological status , and pain . Data from the clinical and health status measures produced highly similar conclusions : injectable and oral gold are more effective than placebo for rheumatoid arthritis , and injections are slightly more effective than oral gold . The health status measure was thus quite sensitive to clinical ly meaningful drug-induced improvements . These findings provide justification for the further application of health status measures to clinical trials of chronic disease",
"OBJECTIVE To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology ( ACR ) and the Outcome Measures in Clinical Trials ( OMERACT ) conference committee to be used in clinical trials of rheumatoid arthritis ( RA ) . METHODS Utilizing data from a multicenter r and omized double-blind clinical trial of low-dose cyclosporine and placebo in RA , we estimated the relative efficiency ( RE ) of measures to detect a treatment effect ( relative to tender joint count , which was assigned a value of 1 ) . Four pain measures ( 10-cm visual analog scale [ VAS ] , 5-point categorical scale , Health Assessment Question naire [ HAQ ] pain index , Arthritis Impact Measurement Scales [ AIMS ] pain score ) and 3 quality -of-life measures ( Problem Elicitation Technique [ PET ] , HAQ , AIMS ) were compared . RESULTS Physician and patient global measures were the most responsive instruments , although neither was statistically superior to tender joint count . Swollen joint count , grip strength , pain measured on a 10-cm VAS , and functional status as measured by the PET and HAQ were all of intermediate responsiveness . Morning stiffness , 5-point pain scale , and erythrocyte sedimentation rate were the least responsive instruments . CONCLUSION This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT",
"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",
"Observational and longitudinal observational studies ( LOS ) provide essential information about the course and outcome of rheumatic disorders that can not be provided by r and omized controlled trials , and they constitute the major clinical scientific communication in rheumatology . There has been no consensus as to the full and appropriate content of LOS . This report defines a core set of domains and reporting requirements for LOS . At the 1998 OMERACT IV Conference a consensus process evaluated the literature of rheumatology in light of the constructs , variables , and outcomes of rheumatology by using introductory lectures , nominal groups , and plenary sessions . The result of this process was to identify 5 \" core \" domains that should be included in every LOS : Health Status , Disease Process , Damage , Mortality , and Toxicity/Adverse Reactions . Two additional domains , Work Disability and Costs , were recognized as important , but need not be used in all LOS . Eleven subdomains were identified that divided the domains into convenient clinical and conceptual units . A set of reporting requirements was also determined . The core recommendations , which follow on the WHO ICIDH-2 outline , are not disease-specific ; the substitution of different \" disease process \" and \" damage \" measures make them suitable for many rheumatic disorders . The core set is intended to serve as a core for LOS in almost all rheumatic conditions",
"OBJECTIVE Validation of responsiveness and discriminative power of the World Health Organisation/International League of Associations for Rheumatology ( WHO/ILAR ) core set , the American College of Rheumatology ( ACR ) , and European League for Rheumatology ( EULAR ) criteria for improvement/response , and other single and combined measures ( indices ) in a trial in patients with early rheumatoid arthritis ( RA ) . METHODS Ranking of measures by response ( st and ardised response means and effect sizes ) and between-group discrimination ( unpaired ttest and χ2 values ) at two time points in the COBRA study . This study included 155 patients with early RA r and omly allocated to two treatment groups with distinct levels of expected response : combined treatment , high response ; sulfasalazine treatment , moderate response . RESULTS At week 16 , st and ardised response means of core set measures ranged between 0.8 and 3.5 for combined treatment and between 0.4 and 1.2 for sulfasalazine treatment ( 95 % confidence interval ±0.25 ) . Performance of patient oriented measures ( for example , pain , global assessment ) was best when the questions were focused on the disease . The most responsive single measure was the patient 's assessment of change in disease activity , at 3.5 . Patient utility , a generic health status measure , was moderately ( rating scale ) to poorly ( st and ard gamble ) responsive . Response means of most indices ( combined measures ) exceeded 2.0 , the simple count of core set measures improved by 20 % was most responsive at 4.1 . Discrimination performance yielded similar but not identical results : best discrimination between treatment groups was achieved by the EULAR response and ACR improvement criteria ( at 20 % and other percentage levels ) , the pooled index , and the disease activity score ( DAS ) , but also by the Health Assessment Question naire ( HAQ ) and grip strength . CONCLUSIONS Responsiveness and discrimination between levels of response are not identical concepts , and need separate study . The WHO/ILAR core set comprises responsive measures that discriminate well between different levels of response in early RA . However , the performance of patient oriented measures is highly dependent on their format . The excellent performance of indices such as the ACR improvement and EULAR response criteria confirms that they are the preferred primary end point in RA clinical trials",
"OBJECTIVE To assess the performance of the Barthel Index ( BI ) in patients with rheumatoid arthritis ( RA ) in the acute care hospital , as compared to the Stanford Health Assessment Question naire ( HAQ ) and the Hannover Functional Question naire ( Funktionsfragebogen Hannover , FFbH ) . METHODS A prospect i ve study of 97 patients with RA admitted to an acute rheumatology hospital with new onset or acute flare of RA . Patients were required to self-complete the BI , the HAQ , and the FFbH. Disease activity was measured using the Disease Activity Score ( DAS28 ) . RESULTS Seventy-eight percent of patients were female , average age was 61.5 ( SD 12.5 ) years , and 72.2 % were rheumatoid factor-positive . The median HAQ was 1.29 ( range 0 - 3 ) , median FFbH was 50 % ( 6 - 100 % ) , and median BI was 95 ( 0 - 100 ) , and distribution was highly skewed . All measures of physical functioning were significantly correlated with each other and with the DAS28 ; however , the BI discriminated poorly between low and high disease activity . CONCLUSION The BI is not a useful instrument to assess physical functioning in patients with acute symptoms of RA , but may have a role in assessing patients with comorbidities and in assessing nursing care needs in the acute care hospital",
"Objectives For the measurement of patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields",
"As an alternative to the calculation of change scores for health status question naires used in clinical trials or longitudinal studies , transitional questions have been developed for patients to assess changes directly themselves . Here the original Health Assessment Question naire ( HAQ ) is compared with a modified version of the HAQ ( MHAQ ) which contains transition questions used at follow up . These , together with a set of st and ard rheumatological tests , were all completed by 100 patients with rheumatoid arthritis on two occasions , three months apart . Change scores were calculated for the HAQ and for the clinical measures and compared with the MHAQ . The results were strikingly in favour of encouraging patients to assess their own degree of change through the use of transition questions in the MHAQ",
"OBJECTIVE To define clinical ly meaningful changes in 2 widely used health-related quality of life ( HQL ) instruments in studies of patients with rheumatoid arthritis ( RA ) . METHODS Patients with RA ( n = 693 ) who were enrolled in 2 double-blind , placebo-controlled clinical trials completed the Short Form 36 ( SF-36 ) modified health survey and the Health Assessment Question naire ( HAQ ) disability index at baseline and 6-week followup assessment s. Data on 5 RA severity measures were also collected at baseline and at 6 weeks ( patient and physician global assessment s , joint swelling and tenderness counts , and global pain assessment ) . Comparison of changes in the SF-36 scales and HAQ scores was made between groups of patients known to differ in the level of change on each RA severity measure . RESULTS With few exceptions , changes in the SF-36 and HAQ scores were different between patients who differed in the level of change on each RA severity measure . Changes in the SF-36 and HAQ scores were more strongly related to changes in the patient and physician global assessment s and patient pain assessment than to changes in the joint swelling and tenderness counts . CONCLUSION Based on these results , minimally important changes in the SF-36 scales and HAQ disability scores were determined , which will be useful in interpreting HQL results in clinical trials",
"We present data from two studies which clarify the relationship between the responsiveness and validity of instruments design ed to measure health status in clinical trials . In a controlled trial of long vs short duration adjuvant chemotherapy for women with Stage II breast cancer , the Breast Cancer Chemotherapy Question naire ( BCQ ) proved valid as a measure of subjective health status and was able to distinguish long vs short arms . Well vali date d measures of physical and emotional function developed by the R and Corporation were unable to distinguish between the two groups . The Eastern Co-operative Oncology Group Criteria ( ECOG ) distinguished the two groups , but failed criteria of clinical sensibility as a measure of subjective health status . In a study of patients with Crohn 's disease and ulcerative colitis , the Inflammatory Bowel Disease Question naire ( IBDQ ) showed small intrasubject variability over time . Gobal ratings of change showed moderate to high correlations with changes in IBDQ score , and patients who reported overall improvement or deterioration showed large changes in IBDQ score . Each of these findings support , in different ways , the reproducibility , validity , and responsiveness of the question naire . While the same data can at times bear on both validity and responsiveness , when assessing evaluative instruments it is useful to make a conceptual distinction between the two",
"OBJECTIVE To examine correlations between clinical improvement as defined by the American College of Rheumatology ( ACR ) responder analysis and clinical improvement as determined by 4 function and /or health-related quality of life measures , and to estimate the sensitivity and relative efficiency of these measures compared with changes in the tender joint count in patients with rheumatoid arthritis ( RA ) . METHODS A 52-week , multicenter , double-blind controlled trial was conducted to compare treatment with leflunomide ( n = 182 ) , methotrexate ( n = 180 ) , or placebo ( n = 118 ) in patients with active RA . ACR response rates and improvement in scores on the Health Assessment Question naire ( HAQ ) , Problem Elicitation Technique ( PET ) , and Medical Outcomes Survey Short Form 36 ( SF-36 ) were compared in 438 of the patients . RESULTS In comparing leflunomide with placebo , the patient global assessment , HAQ disability index , and SF-36 bodily pain scale were most responsive to treatment group differences . The modified HAQ ( M-HAQ ) , PET Top 5 , SF-36 physical component score , physician global assessment , pain intensity scale , and SF-36 physical functioning scale were more responsive to treatment group differences than was the tender joint count . In comparing methotrexate with placebo , the patient and physician global assessment s were most responsive . These 2 measures , as well as the pain intensity scale and the C-reactive protein level , were more responsive to treatment group differences than was the tender joint count , while the SF-36 mental health component score was least responsive . A close correlation between changes in the M-HAQ and HAQ scores indicated that the M-HAQ was similarly responsive to change over time . Improvements in the PET , SF-36 physical component score , bodily pain , and physical functioning scales correlated with the ACR responder status . CONCLUSION Both disease-specific and generic measures of function and health-related quality of life detect improvements in RA patients . Using both types of measures for evaluating therapies will identify discernible changes that are important to patients , and will facilitate comparisons across different disease states",
"This study examined the validity and reliability of full and short versions of the Arthritis Impact Measurement Scales ( AIMS ) . One hundred fifty-five patients with Rheumatoid Arthritis followed at a University Hospital Rheumatology Clinic completed the full AIMS at baseline , 6 months , 12 months , and 18 months . After reducing the 45-item AIMS to 22 , alpha reliabilities and test-retest correlations showed that , with the exception of test-retest correlations for mobility at 6 months and for pain at 12 and 18 months , the full and short scales were comparably reliable . Convergent validity correlations with theoretically related scales were also comparable . However , some of the short scales did not detect the same differences over time that the full scales did . Specifically , the short mobility , pain , anxiety , and depression scales were not as sensitive to change as the full scales . Except for these four scales , the short version appears to be a viable alternative for use by health professionals and research ers",
"To assess the sensitivity of the Arthritis Impact Measurement Scales ( AIMS ) , we analyzed data from 3 clinical trials . One trial involving 255 patients with rheumatoid arthritis ( RA ) was a 12-week , r and omized controlled trail of diclofenac , naproxen , and aspirin . Two trials were open-label studies of 24 weeks duration that included 165 RA and 355 osteoarthritis ( OA ) patients , all of whom were treated with diclofenac . In addition to the AIMS , tender joint count , morning stiffness , and erythrocyte sedimentation rate were used as outcome measures in the trials . The AIMS results showed substantial improvements in Physical Function , Psychological Status , and Pain , as well as in overall Arthritis Impact . These improvements were detected by the time of the initial outcome assessment at 4 weeks or 8 weeks , and were detected in patients with either OA or RA . These AIMS results closely parallel improvements shown by traditional clinical measures , and demonstrate that the AIMS health status measure is sensitive to improvements in OA as well as in RA . The AIMS also detects responses produced by therapy with nonsteroidal antiinflammatory drugs ( NSAIDs ) , and these improvements can be demonstrated in as short a treatment time as 4 weeks . These findings confirm the utility of the AIMS for assessing outcome in rheumatic disease studies , and they have implication s for the design of future clinical trials of NSAIDs",
"OBJECTIVE To vali date a translated and culturally adapted version of the Arthritis Impact Measurement Scale ( AIMS ) 2 in primary care patients with osteoarthritis ( OA ) of the hip and knee . METHOD The AIMS 2 was translated into German and culturally adapted . The question naire then was administered to 220 primary care patients with OA of the knee or hip . Two hundred and nine question naires were returned and analysed . Test-retest reliability was tested in 50 r and omly selected patients , of those 42 completed the question naire after 2 weeks for a second time . RESULTS Item-scale correlations were reasonably good as well as the discriminative power of separate scales . The assessment of internal consistency reliability also revealed satisfactory values ; Cronbach 's alpha was 0.77 or higher for all scales . The test-retest reliability , estimated in an intraclass correlation coefficient ( ICC ) , exceeded 0.90 , except the \" social activities \" scale ( 0.87 ) . Since only patients with OA of the lower limb were enrolled , substantial floor effects occurred in the \" arm function \" ( 28.2 % ) and the \" h and and finger function \" scale ( 29.2 % ) . The principal factor analysis confirmed the postulated three-factor structure with a physical , physiological and social dimension , explaining 48.5 % , 13.9 % and 6.8 % of the variation , respectively . External validity was assessed by calculating correlations to the Western Ontario and MacMaster ( WOMAC ) osteoarthritis question naire a pain visual analogue scale ( VAS ) and the Kellgren score as well as to disease duration . Spearman 's \" R \" achieved satisfactory values for the corresponding WOMAC scales and the pain-VAS . Correlations with disease duration as well as with the radiological grading were low . CONCLUSION The GERMAN- AIMS 2 is a reliable and valid instrument to assess the quality of life ( QoL ) in primary care patients suffering from OA",
"Twenty-eight instruments measuring pain , clinical , functional , and global characteristics were administered to 303 patients in a six-month r and omized clinical trial of auranofin and placebo in the treatment of patients with rheumatoid arthritis . The instruments were compared with respect to their responsiveness in detecting a treatment effect , the time involved in administering the instrument , the need for the presence of an interviewer , and ease of administration . The instruments ' ability to detect a treatment effect was the deciding characteristic in the clinical , pain , and global categories in choosing the preferred instrument . The counts of tender and swollen joints were found to be the most responsive clinical measures , the 10-cm pain line was the most responsive and the fastest to administer of the pain instruments , and the categorical self- assessment of arthritis was the most responsive global measure . In the functional ability category , the Health Assessment Question naire ( HAQ ) , the Keitel Functional Assessment , and the Quality of Well-Being ( QWB ) Question naire were equally responsive . The HAQ was the shortest and the only self-administered question naire . The QWB has had the most extensive validation work but was a complex instrument requiring intensive interviewer training . The Keitel was the most time-consuming instrument , but had the advantage of high interobserver agreement . The design of future trials can be guided by the information obtained in this study on their relative efficiencies and ease of use",
"OBJECTIVE To assess the psychometric characteristics of the original 33-item Cedars-Sinai Health-Related Quality of Life in Rheumatoid Arthritis Question naire ( O-CSHQ-RA ) and 11-item CSHQ-RA Short Form ( SF ) using a representative population of patients with rheumatoid arthritis ( RA ) from 55 sites across the United States . METHODS Data were from a 24-week multicenter , open-label , single-arm study of 312 RA patients receiving anakinra . Cronbach 's alpha coefficient was used to indicate the internal consistency . Test-retest reliability was assessed by establishing the intraclass correlation coefficient ( ICC ) for screening and baseline visit responses . Convergent validity was tested with the Pearson correlation coefficient . Analysis of variance was performed to determine discriminant validity . A Wilcoxon signed-rank test and analysis of covariance were used to assess the responsiveness . A discriminant function was generated to determine the clinical ly meaningful change . RESULTS Test-retest reliability was demonstrated for both versions of the CSHQ-RA , with ICC ranging from 0.82 to 0.94 . Cronbach 's alpha coefficients were > or = 0.9 , indicating good internal consistency . Pearson correlations between health-related quality of life instruments and CSHQ-RA measures ranged from -0.33 to -0.73 and 0.39 to 0.76 , demonstrating good convergent validity . Scores on both versions of the CSHQ-RA differed significantly ( p disability as measured by the Stanford Health Assessment Question naire . Both instruments were responsive to differences in patient health as measured by the general health question ( p CSHQ-RA and the 11-item CSHQ-RA SF when tested in a representative patient population"
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41172224-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND We sought to examine the efficacy and safety of 2 PCSK9 ( proprotein convertase subtilisin/kexin type 9 ) inhibitors : alirocumab and evolocumab . METHODS AND RESULTS We performed a systematic review and meta- analysis of r and omized controlled trials comparing treatment with and without PCSK9 inhibitors ; 35 r and omized controlled trials comprising 45 539 patients ( mean follow-up : 85.5 weeks ) were included . Mean age was 61.0±2.8 years , and mean baseline low-density lipoprotein cholesterol was 106±22 mg/dL. Compared with no PCSK9 inhibitor therapy , treatment with a PCSK9 inhibitor was associated with a lower rate of myocardial infa rct ion ( 2.3 % versus 3.6 % ; odds ratio [ OR ] : 0.72 [ 95 % confidence interval ( CI ) , 0.64 - 0.81 ] ; P ) , stroke ( 1.0 % versus 1.4 % ; OR : 0.80 [ 95 % CI , 0.67 - 0.96 ] ; P=0.02 ) , and coronary revascularization ( 4.2 % versus 5.8 % ; OR : 0.78 [ 95 % CI , 0.71 - 0.86 ] ; P observed in all-cause mortality ( OR : 0.71 [ 95 % CI , 0.47 - 1.09 ] ; P=0.12 ) or cardiovascular mortality ( OR : 1.01 [ 95 % CI , 0.85 - 1.19 ] ; P=0.95 ) . A significant association was observed between higher baseline low-density lipoprotein cholesterol and benefit in all-cause mortality ( P=0.038 ) . No significant change was observed in neurocognitive adverse events ( OR : 1.12 [ 95 % CI , 0.88 - 1.42 ] ; P=0.37 ) , myalgia ( OR : 0.95 [ 95 % CI , 0.75 - 1.20 ] ; P=0.65 ) , new onset or worsening of preexisting diabetes mellitus ( OR : 1.05 [ 95 % CI , 0.95 - 1.17 ] ; P=0.32 ) , and increase in levels of creatine kinase ( OR : 0.84 [ 95 % CI , 0.70 - 1.01 ] ; P=0.06 ) or alanine or aspartate aminotransferase ( OR : 0.96 [ 95 % CI , 0.82 - 1.12 ] ; P=0.61 ) . CONCLUSIONS Treatment with a PCSK9 inhibitor is well tolerated and improves cardiovascular outcomes . Although no overall benefit was noted in all-cause or cardiovascular mortality , such benefit may be achievable in patients with higher baseline low-density lipoprotein cholesterol
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"BACKGROUND The ODYSSEY COMBO I study ( http:// clinical trials.gov/show/NCT01644175 ) evaluated efficacy and safety of alirocumab as add-on therapy to stable maximally tolerated daily statin with or without other lipid-lowering therapy in high cardiovascular risk patients with suboptimally controlled hypercholesterolemia . METHODS This multicenter , phase 3 , r and omized ( 2:1 alirocumab vs placebo ) , double-blind , 52-week trial enrolled 316 patients with established coronary heart disease or coronary heart disease risk equivalents and hypercholesterolemia . Alirocumab ( 75 mg every 2 weeks [ Q2W ] ) or placebo Q2W was self-administered subcutaneously via 1 mL prefilled pen . The alirocumab dose was increased to 150 mg Q2W ( also 1 mL ) at week 12 if week 8 low-density lipoprotein cholesterol ( LDL-C ) was ≥70 mg/dL. The primary efficacy end point was percent change in LDL-C from baseline to week 24 ( intention-to-treat analysis ) . RESULTS At week 24 , estimated mean ( 95 % CI ) changes in LDL-C from baseline were -48.2 % ( -52.0 % to -44.4 % ) and -2.3 % ( -7.6 % to 3.1 % ) for alirocumab and placebo , respectively , an estimated mean ( 95 % CI ) difference of -45.9 % ( -52.5 % to -39.3 % ) ( P % alirocumab versus 9 % placebo patients at week 24 . At week 12 , 83.2 % of evaluable alirocumab-treated patients remained on 75-mg Q2W . Treatment-emergent adverse events were comparable between groups . CONCLUSIONS Alirocumab treatment achieved a significantly greater reduction in LDL-C and allowed a greater proportion of patients to achieve LDL-C goals , versus placebo after 24 weeks in high cardiovascular risk patients with suboptimally controlled hypercholesterolemia at baseline despite receiving maximally tolerated statin with or without other lipid-lowering therapy . The frequency of treatment-emergent adverse events and study medication discontinuations were generally comparable between treatment groups",
"Aims To compare the efficacy [ low-density lipoprotein cholesterol ( LDL-C ) lowering ] and safety of alirocumab , a fully human monoclonal antibody to proprotein convertase subtilisin/kexin 9 , compared with ezetimibe , as add-on therapy to maximally tolerated statin therapy in high cardiovascular risk patients with inadequately controlled hypercholesterolaemia . Methods and results COMBO II is a double-blind , double-dummy , active-controlled , parallel-group , 104-week study of alirocumab vs. ezetimibe . Patients ( n = 720 ) with high cardiovascular risk and elevated LDL-C despite maximal doses of statins were enrolled ( August 2012–May 2013 ) . This pre-specified analysis was conducted after the last patient completed 52 weeks . Patients were r and omized to subcutaneous alirocumab 75 mg every 2 weeks ( plus oral placebo ) or oral ezetimibe 10 mg daily ( plus subcutaneous placebo ) on a background of statin therapy . At Week 24 , mean ± SE reductions in LDL-C from baseline were 50.6 ± 1.4 % for alirocumab vs. 20.7 ± 1.9 % for ezetimibe ( difference 29.8 ± 2.3 % ; P % of alirocumab and 45.6 % of ezetimibe patients achieved LDL-C LDL-C at Week 24 was 1.3 ± 0.04 mmol/L with alirocumab and 2.1 ± 0.05 mmol/L with ezetimibe , and were maintained to Week 52 . Alirocumab was generally well tolerated , with no evidence of an excess of treatment-emergent adverse events . Conclusion In patients at high cardiovascular risk with inadequately controlled LDL-C , alirocumab achieved significantly greater reductions in LDL-C compared with ezetimibe , with a similar safety profile . Trial registration clinical trials.gov Identifier : NCT01644188",
"Aim To evaluate the effect of alirocumab on frequency of st and ard apheresis treatments [ weekly or every 2 weeks ( Q2W ) ] in heterozygous familial hypercholesterolaemia ( HeFH ) . Methods and results ODYSSEY ESCAPE ( NCT02326220 ) was a double-blind study in 62 HeFH patients undergoing regular weekly or Q2W lipoprotein apheresis . Patients were r and omly assigned ( 2:1 , respectively ) to receive alirocumab 150 mg ( n = 41 ) or placebo ( n = 21 ) Q2W subcutaneously for 18 weeks . From day 1 to week 6 , apheresis rate was fixed according to the patient ’s established schedule ; from weeks 7 to 18 , apheresis rate was adjusted based on the patient ’s low-density lipoprotein cholesterol ( LDL-C ) response in a blinded fashion . Apheresis was not performed when the LDL-C value was ≥30 % lower than the baseline ( pre-apheresis ) value . The primary efficacy endpoint was the rate of apheresis treatments over 12 weeks ( weeks 7–18 ) , st and ardized to number of planned treatments . In the alirocumab group the least square ( LS ) mean ± SE ( 95 % confidence interval [ CI ] ) per cent change in pre-apheresis LDL-C from baseline at week 6 was −53.7 ± 2.3 ( −58.2 to − 49.2 ) compared with 1.6 ± 3.1 ( –4.7 to 7.9 ) in the placebo group . The primary efficacy endpoint showed statistically significant benefit in favour of alirocumab ( Hodges – Lehmann median estimate of treatment difference : 0.75 ; 95 % CI 0.67–0.83 ; P , alirocumab-treated patients had a 0.75 ( 75 % ) additional reduction in the st and ardized rate of apheresis treatments vs. placebo-treated patients . During this period , 63.4 % of patients on alirocumab avoided all and 92.7 % avoided at least half of the apheresis treatments . Adverse event rates were similar ( 75.6 % of patients on alirocumab vs. 76.2 % on placebo ) . Conclusions Lipoprotein apheresis was discontinued in 63.4 % of patients on alirocumab who were previously undergoing regular apheresis , and the rate was at least halved in 92.7 % of patients . Alirocumab was generally safe and well tolerated",
"Purpose Even with statins and other lipid-lowering therapy ( LLT ) , many patients with heterozygous familial hypercholesterolemia ( heFH ) continue to have elevated low-density lipoprotein cholesterol ( LDL-C ) levels . ODYSSEY HIGH FH ( NCT01617655 ) assessed the efficacy and safety of alirocumab , a proprotein convertase subtilisin/kexin type 9 monoclonal antibody , versus placebo in patients with heFH and LDL-C ≥ 160 mg/dl despite maximally tolerated statin ± other LLT . Methods Patients were r and omized to subcutaneous alirocumab 150 mg or placebo every 2 weeks ( Q2W ) for 78 weeks . The primary endpoint was percent change in LDL-C from baseline to week 24 . Results Mean baseline LDL-C levels were 196.3 mg/dl in the alirocumab ( n = 71 ) and 201.0 mg/dl in the placebo groups ( n = 35 ) . Significant mean ( st and ard error [ SE ] ) reductions in LDL-C from baseline to week 24 were observed with alirocumab ( −45.7 [ 3.5 ] % ) versus placebo ( −6.6 [ 4.9 ] % ) , a difference of −39.1 ( 6.0 ) % ( P were reduced from baseline by 90.8 ( 6.7 ) mg/dl with alirocumab at week 24 , with reductions maintained to week 78 . Treatment-emergent adverse events were generally comparable between groups . Injection-site reactions were more frequent in the alirocumab group ( 8.3 % ) versus placebo ( 5.7 % ) ; most were mild in severity and did not result in study medication discontinuation . Conclusions In patients with heFH and very high LDL-C baseline levels despite maximally tolerated statin ± other LLT , alirocumab 150 mg Q2W demonstrated significant reductions in LDL-C levels with 41 % of patients achieving predefined LDL-C goals . Alirocumab was generally well tolerated",
"Bococizumab is a humanized monoclonal antibody binding proprotein convertase subtilisin/kexin type 9 , which may be a potential therapeutic option for reducing low-density lipoprotein cholesterol ( LDL-C ) levels in patients with hypercholesterolemia . In this 24-week , multicenter , double-blind , placebo-controlled , dose-ranging study ( NCT01592240 ) , subjects with LDL-C levels≥80 mg/dl on stable statin therapy were r and omized to Q14 days subcutaneous placebo or bococizumab 50 , 100 , or 150 mg or Q28 days subcutaneous placebo or bococizumab 200 or 300 mg . Doses of bococizumab were reduced if LDL-C levels persistently decreased to ≤25 mg/dl . The primary end point was the absolute change in LDL-C levels from baseline to week 12 after placebo or bococizumab administration . Continuation of bococizumab administration through to week 24 enabled the collection of safety data over an extended period . Of the 354 subjects r and omized , 351 received treatment ( placebo [ n=100 ] or bococizumab [ n=251 ] ) . The most efficacious bococizumab doses were 150 mg Q14 days and 300 mg Q28 days . Compared with placebo , bococizumab 150 mg Q14 days reduced LDL-C at week 12 by 53.4 mg/dl and bococizumab 300 mg Q28 days reduced LDL-C by 44.9 mg/dl ; this was despite dose reductions in 32.5 % and 34.2 % of subjects at week 10 or 8 , respectively . Pharmacokinetic/pharmacodynamic model-based simulation assuming no dose reductions predicted that bococizumab would lower LDL-C levels by 72.2 and 55.4 mg/dl , respectively . Adverse events were similar across placebo and bococizumab groups . Few subjects ( n=7 ; 2 % ) discontinued treatment because of treatment-related adverse events . In conclusion , bococizumab significantly reduced LDL-C across all doses despite dose reductions in many subjects . Model-based simulations predicted greater LDL-C reduction in the absence of bococizumab dose reduction . The Q14 days regimen is being evaluated in phase 3 clinical trials",
"BACKGROUND Efficacy and safety of alirocumab were compared with ezetimibe in hypercholesterolemic patients at moderate cardiovascular risk not receiving statins or other lipid-lowering therapy . METHODS In a Phase 3 , r and omized , double-blind , double-dummy study ( NCT01644474 ) , patients ( low-density lipoprotein cholesterol [ LDL-C ] 100 - 190 mg/dL , 10-year risk of fatal cardiovascular events ≥ 1%- were r and omized to ezetimibe 10mg/day ( n=51 ) or alirocumab 75 mg subcutaneously ( via 1-mL autoinjector ) every 2 weeks ( Q2W ) ( n=52 ) , with dose up-titrated to 150 mg Q2W ( also 1 mL ) at week 12 if week 8 LDL-C was ≥ 70 mg/dL. Primary endpoint was mean LDL-C % change from baseline to 24 weeks , analyzed using all available data ( intent-to-treat approach , ITT ) . Analyses using on-treatment LDL-C values were also conducted . RESULTS Mean ( SD ) baseline LDL-C levels were 141.1 ( 27.1 ) mg/dL ( alirocumab ) and 138.3 ( 24.5 ) mg/dL ( ezetimibe ) . The 24-week treatment period was completed by 85 % of alirocumab and 86 % of ezetimibe patients . Least squares mean ( SE ) LDL-C reductions were 47 (3)% with alirocumab versus 16 (3)% with ezetimibe ( ITT ; p , alirocumab 75 mg Q2W reduced LDL-C by 53 (2)% ( on-treatment ) . Injection site reactions were infrequent ( CONCLUSIONS Alirocumab demonstrated significantly greater LDL-C lowering versus ezetimibe after 24 weeks with the lower 75 mg Q2W dose sufficient to provide ≥ 50 % LDL-C reduction in the majority of the patients . Adverse events were comparable between groups",
"BACKGROUND AND AIMS In previous phase III studies , the PCSK9 monoclonal antibody alirocumab was administered at doses of 75 or 150 mg every 2 weeks ( Q2W ) . CHOICE I ( NCT01926782 ) evaluated 300 mg every 4 weeks ( Q4W ) in patients on either maximally tolerated statin or no statin , both ± other lipid-lowering therapies . METHODS CHOICE I included patients with hypercholesterolemia at moderate-to-very-high cardiovascular risk . Patients were r and omized to alirocumab 300 mg Q4W , 75 mg Q2W ( calibrator arm ) , or placebo for 48 weeks , with dose adjustment for either alirocumab arm to 150 mg Q2W at Week ( W ) 12 if at W8 LDL-C levels were > 70/100 mg/dL ( 1.8/2.6 mmol/L ) depending on cardiovascular risk or LDL-C reduction was percent LDL-C change from baseline to W24 , and to time-averaged LDL-C over W21 - 24 . RESULTS Approximately two-thirds of r and omized patients were receiving statins . At W12 , 14.7 % ( no statin ) and 19.3 % ( statin ) of patients receiving alirocumab 300 mg Q4W required dose adjustment . At W24 , significant LDL-C reductions from baseline were observed with alirocumab 300 mg Q4W : mean differences were -52.7 % ( no statin ; placebo : -0.3 % ) and -58.8 % ( statin ; placebo : -0.1 % ) . Average LDL-C reductions from baseline to W21 - 24 were also significantly greater with alirocumab 300 mg Q4W vs. placebo in patients not receiving ( -56.9 % vs. -1.6 % ) and receiving statin ( -65.8 % vs. -0.8 % ) . Treatment-emergent adverse event rates ranged from 61.1 to 75.0 % ( placebo ) and 71.5 to 78.1 % ( alirocumab 300 mg Q4W ) . CONCLUSIONS Alirocumab 300 mg Q4W is a viable additional treatment option in patients requiring LDL-C-lowering ",
"Aims Statins have modest adverse effects on glycaemic control . Alirocumab , a proprotein convertase subtilisin/kexin type 9 inhibitor , lowers low-density lipoprotein cholesterol . This study assessed the effects of alirocumab on new-onset diabetes and pre-diabetes incidence in individuals without diabetes at baseline . Methods and results Pooled analysis of 10 ODYSSEY Phase 3 trials ( n = 4974 ) of 24–104 weeks duration . Six trials ( n = 4211 ) were ≥52 weeks in length . Most patients received background maximally tolerated statin . Alirocumab effect on the rate of diabetes-related treatment-emergent adverse events ( TEAEs ) , and /or fasting plasma glucose ( FPG ) and glycated haemoglobin A1C ( HbA1C ) was measured at baseline and every 12–24 weeks . Transition to diabetes analysis combined TEAE and FPG/HbA1C laboratory data . At baseline , 30.7 % of individuals had diabetes and were excluded from the current analysis . The remaining 3448 individuals without diabetes had pre-diabetes ( 39.6 % ) or were normoglycaemic ( 29.7 % ) . The hazard ratio ( HR ; 95 % confidence interval ) for diabetes-related TEAEs in alirocumab was 0.64 ( 0.36–1.14 ) vs. placebo and 0.55 ( 0.22–1.41 ) vs. ezetimibe . The HR associated for transition from pre-diabetes to new-onset diabetes for alirocumab was 0.90 ( 0.63–1.29 ) vs. placebo and 1.10 ( 0.57–2.12 ) vs. ezetimibe . Mean change in FPG/HbA1C over time showed no difference between treatment groups in patients without diabetes . Conclusions There was no evidence of an effect of alirocumab on transition to new-onset diabetes in 3448 individuals without diabetes at baseline with a follow-up period of 6–18 months , compared to either placebo or ezetimibe . Longer follow-up with larger number of individuals is needed to conclusively rule out an effect",
"Background Evidence -based r and omized clinical trials have shown significant benefit of statin treatment with regard to cardiovascular disease . In anticipation of the National Cholesterol Education Program Adult Treatment Panel IV guidelines , we wanted to assess the current state of lipid goal attainment in the high-risk secondary prevention population in the United States . The objectives of the study were to estimate the proportion of high-risk patients treated with statin monotherapy who achieved Adult Treatment Panel III – recommended low-density lipoprotein cholesterol ( LDL-C ) goals ( 3 data sources : electronic medical records ( 2003–September 2010 ) , administrative cl aims data ( 2003–2010 ) , and National Health and Nutrition Examination Survey data ( 2007–2008 ) . High-risk patients ( ≥18 years of age ) were defined as those with a history of coronary heart disease or coronary heart disease risk equivalent who had the latest complete lipid panel measurement and had been treated with statin monotherapy for > 90 days at the time of the lipid panel . Cardiovascular disease , coronary heart disease , and coronary heart disease risk equivalents were defined on the basis of availability , specific to each data source . Across the 3 data sources , 20 % to 26 % of high-risk patients treated with statin monotherapy for > 90 days had LDL-C attaining both LDL-C goals and non – high-density lipoprotein cholesterol goals were quantitatively smaller ( 13.5 % to 19.0 % and 46 % to 70 % ) . Conclusions Across the 3 data sources , there was consistency in the proportion of high-risk patients treated with statin monotherapy who were at LDL-C goal . A significant number of these statin-treated patients had additional dyslipidemias",
"BACKGROUND YUKAWA is a 12-week , r and omized , double-blind , placebo-controlled , phase 2 study evaluating the efficacy and safety of evolocumab ( AMG 145 ) in statin-treated Japanese patients at high cardiovascular risk . METHODS AND RESULTS 310 eligible patients receiving stable statin ( ±ezetimibe ) therapy were r and omized to 1 of 6 treatments : placebo every 2 weeks ( Q2W ) or monthly ( QM ) , evolocumab 70 mg or 140 mg Q2W , or evolocumab 280 mg or 420 mg QM . The primary endpoint was the percentage change from baseline in low-density lipoprotein cholesterol ( LDL-C ) measured by preparative ultracentrifugation ( UC ) . Secondary endpoints included percentage changes in other lipid parameters and the proportion of patients with LDL-C Mean ( SD ) age was 62 ( 10 ) years ; 37 % were female ; and the mean ( SD ) baseline LDL-C was 3.7 ( 0.5 ) mmol/L ( by UC ) . Mean ( SE ) changes vs. placebo in LDL-C were greatest in the high-dose groups : -68.6 ( 3.0 ) % and -63.9 ( 3.2 ) % with 140 mg Q2W and 420 mg QM dosing , respectively . Up to 96 % of evolocumab-treated patients achieved LDL-C mmol/L. Adverse events ( AEs ) were more frequent in evolocumab ( 51 % ) vs. placebo ( 38 % ) patients ; 4 patients taking evolocumab discontinued treatment because of an AE . There were no significant differences in AE rates based on dose or dose frequency . CONCLUSIONS In Japanese patients at high cardiovascular risk with hypercholesterolemia on stable statin therapy , evolocumab significantly reduced LDL-C and was well tolerated during this 12-week study",
"Aims To assess long-term ( 78 weeks ) alirocumab treatment in patients with heterozygous familial hypercholesterolaemia ( HeFH ) and inadequate LDL-C control on maximally tolerated lipid-lowering therapy ( LLT ) . Methods and results In two r and omized , double-blind studies ( ODYSSEY FH I , n = 486 ; FH II , n = 249 ) , patients were r and omized 2 : 1 to alirocumab 75 mg or placebo every 2 weeks ( Q2W ) . Alirocumab dose was increased at Week 12 to 150 mg Q2W if Week 8 LDL-C was ≥1.8 mmol/L ( 70 mg/dL ) . Primary endpoint ( both studies ) was percentage change in calculated LDL-C from baseline to Week 24 . Mean LDL-C levels decreased from 3.7 mmol/L ( 144.7 mg/dL ) at baseline to 1.8 mmol/L ( 71.3 mg/dL ; −57.9 % vs. placebo ) at Week 24 in patients r and omized to alirocumab in FH I and from 3.5 mmol/L ( 134.6 mg/dL ) to 1.8 mmol/L ( 67.7 mg/dL ; −51.4 % vs. placebo ) in FH II ( P 78 . LDL-C respectively . Adverse events result ed in discontinuation in 3.4 % of alirocumab-treated patients in FH I ( vs. 6.1 % placebo ) and 3.6 % ( vs. 1.2 % ) in FH II . Rate of injection site reactions in alirocumab-treated patients was 12.4 % in FH I and 11.4 % in FH II ( vs. 11.0 and 7.4 % with placebo ) . Conclusion In patients with HeFH and inadequate LDL-C control at baseline despite maximally tolerated statin ± other LLT , alirocumab treatment result ed in significant LDL-C lowering and greater achievement of LDL-C target levels and was well tolerated . Clinical trial registration Cinicaltrials.gov ( identifiers : NCT01623115 ; NCT01709500 )",
"CONTEXT Despite current st and ard of care , many patients at high risk of cardiovascular disease ( CVD ) still have elevated low-density lipoprotein cholesterol ( LDL-C ) levels . Alirocumab is a fully human monoclonal antibody inhibitor of proprotein convertase subtilisin/kexin type 9 . OBJECTIVE The objective of the study was to compare the LDL-C-lowering efficacy of adding alirocumab vs other common lipid-lowering strategies . DESIGN , PATIENTS , AND INTERVENTIONS Patients ( n = 355 ) with very high CVD risk and LDL-C levels of 70 mg/dL or greater or high CVD risk and LDL-C of 100 mg/dL or greater on baseline atorvastatin 20 or 40 mg were r and omized to one of the following : 1 ) add-on alirocumab 75 mg every 2 weeks ( Q2W ) sc ; 2 ) add-on ezetimibe 10 mg/d ; 3 ) double atorvastatin dose ; or 4 ) for atorvastatin 40 mg regimen only , switch to rosuvastatin 40 mg . For patients not achieving protocol -defined LDL-C goals , the alirocumab dose was increased ( blinded ) at week 12 to 150 mg Q2W . MAIN OUTCOME MEASURE The primary end point was percentage change in calculated LDL-C from baseline to 24 weeks ( intent to treat ) . RESULTS Among atorvastatin 20 and 40 mg regimens , respectively , add-on alirocumab reduced LDL-C levels by 44.1 % and 54.0 % ( P ezetimibe , 20.5 % and 22.6 % ; doubling of atorvastatin dose , 5.0 % and 4.8 % ; and switching atorvastatin 40 mg to rosuvastatin 40 mg , 21.4 % . Most alirocumab-treated patients ( 87.2 % and 84.6 % ) achieved their LDL-C goals . Most alirocumab-treated patients ( 86 % ) maintained their 75-mg Q2W regimen . Treatment-emergent adverse events occurred in 65.4 % of alirocumab patients vs 64.4 % ezetimibe and 63.8 % double atorvastatin/switch to rosuvastatin ( data were pooled ) . CONCLUSIONS Adding alirocumab to atorvastatin provided significantly greater LDL-C reductions vs adding ezetimibe , doubling atorvastatin dose , or switching to rosuvastatin and enabled greater LDL-C goal achievement",
"Summary Background Lowering of LDL cholesterol reduces major vascular events , but whether more intensive therapy safely produces extra benefits is uncertain . We aim ed to establish efficacy and safety of more intensive statin treatment in patients at high cardiovascular risk . Methods We undertook a double-blind r and omised trial in 12 064 men and women aged 18–80 years with a history of myocardial infa rct ion . Participants were either currently on or had clear indication for statin therapy , and had a total cholesterol concentration of at least 3·5 mmol/L if already on a statin or 4·5 mmol/L if not . R and omisation to either 80 mg or 20 mg simvastatin daily was done central ly using a minimisation algorithm . Participants were assessed at 2 , 4 , 8 , and 12 months after r and omisation and then every 6 months until final follow-up . The primary endpoint was major vascular events , defined as coronary death , myocardial infa rct ion , stroke , or arterial revascularisation . Analysis was by intention to treat . This study is registered , number IS RCT N74348595 . Findings 6031 participants were allocated 80 mg simvastatin daily , and 6033 allocated 20 mg simvastatin daily . During a mean follow-up of 6·7 ( SD 1·5 ) years , allocation to 80 mg simvastatin produced an average 0·35 ( SE 0·01 ) mmol/L greater reduction in LDL cholesterol compared with allocation to 20 mg . Major vascular events occurred in 1477 ( 24·5 % ) participants allocated 80 mg simvastatin versus 1553 ( 25·7 % ) of those allocated 20 mg , corresponding to a 6 % proportional reduction ( risk ratio 0·94 , 95 % CI 0·88–1·01 ; p=0·10 ) . There were no apparent differences in numbers of haemorrhagic strokes ( 24 [ 0·4 % ] vs 25 [ 0·4 % ] ) or deaths attributed to vascular ( 565 [ 9·4 % ] vs 572 [ 9·5 % ] ) or non-vascular ( 399 [ 6·6 % ] vs 398 [ 6·6 % ] ) causes . Compared with two ( 0·03 % ) cases of myopathy in patients taking 20 mg simvastatin daily , there were 53 ( 0·9 % ) cases in the 80 mg group . Interpretation The 6 % ( SE 3·5 % ) reduction in major vascular events with a further 0·35 mmol/L reduction in LDL cholesterol in our trial is consistent with previous trials . Myopathy was increased with 80 mg simvastatin daily , but intensive lowering of LDL cholesterol can be achieved safely with other regimens . Funding Merck ; The Clinical Trial Service Unit also receives funding from the UK Medical Research Council and the British Heart Foundation",
"BACKGROUND Inhibition of proprotein convertase subtilisin/kexin type 9 serine protease ( PCSK9 ) result ed in large reductions of low-density lipoprotein cholesterol ( LDL-C ) in phase 1 trials . We assessed the efficacy and safety of various doses and dosing intervals of REGN727 , a monoclonal antibody to PCSK9 , added to statins , to further lower LDL-C in patients with heterozygous familial hypercholesterolaemia . METHODS This multicentre , r and omised , placebo-controlled phase 2 trial was done at 16 lipid clinics in the USA and Canada . Between Jan 18 , 2011 , and Nov 7 , 2011 , we enrolled adults with heterozygous familial hypercholesterolaemia and LDL-C concentrations of 2·6 mmol/L or higher on stable diet and statin dose , with or without ezetimibe . Patients were r and omly assigned to receive REGN727 150 mg , 200 mg , or 300 mg every 4 weeks , or 150 mg every 2 weeks , or placebo every 2 weeks ( ratio 1:1:1:1:1 ) . R and omisation was stratified by concomitant use of ezetimibe at baseline . Investigators , study staff , and patients were masked to treatment group . Blinding was maintained by administration of placebo alternating with REGN727 for the groups of 4 week dosing . The primary endpoint was mean percent reduction in LDL-C from baseline at week 12 and was analysed in the modified intention-to-treat population with an analysis of covariance ( ANCOVA ) model with treatment group . This trial is registered in Clinical Trials.gov , number NCT 01266876 . FINDINGS 77 patients were r and omly assigned to study groups ( 15 - 16 patients per group ) and all were analysed . Least-squares ( LS ) mean LDL-C reduction from baseline to week 12 was 28·9 % ( SE 5·08 ) for 150 mg every 4 weeks ( p=0·0113 ) , 31·54 % ( 4·91 ) for 200 mg every 4 weeks ( p=0·0035 ) , 42·53 % ( 5·09 ) for 300 mg every 4 weeks ( p ) with placebo . One serious adverse event was reported with placebo and none with REGN727 . No increases of more than three times the upper limit of normal were reported for hepatic transaminases or creatinine kinase . The most common adverse event was injection-site reaction with one patient in the group of 300 mg REGN727 terminating treatment . INTERPRETATION REGN727 was well tolerated and achieved substantial further LDL-C reduction in patients with heterozygous familial hypercholesterolaemia and elevated LDL-C treated with high-dose statins , with or without ezetimibe . REGN727 has the potential to provide optimum control of LDL-C in patients with this disorder . FUNDING Sanofi US and Regeneron Pharmaceuticals Incorporated",
"BACKGROUND Alirocumab , a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 ( PCSK9 ) , has been shown to reduce low-density lipoprotein ( LDL ) cholesterol levels in patients who are receiving statin therapy . Larger and longer-term studies are needed to establish safety and efficacy . METHODS We conducted a r and omized trial involving 2341 patients at high risk for cardiovascular events who had LDL cholesterol levels of 70 mg per deciliter ( 1.8 mmol per liter ) or more and were receiving treatment with statins at the maximum tolerated dose ( the highest dose associated with an acceptable side-effect profile ) , with or without other lipid-lowering therapy . Patients were r and omly assigned in a 2:1 ratio to receive alirocumab ( 150 mg ) or placebo as a 1-ml subcutaneous injection every 2 weeks for 78 weeks . The primary efficacy end point was the percentage change in calculated LDL cholesterol level from baseline to week 24 . RESULTS At week 24 , the difference between the alirocumab and placebo groups in the mean percentage change from baseline in calculated LDL cholesterol level was -62 percentage points ( P alirocumab group , as compared with the placebo group , had higher rates of injection-site reactions ( 5.9 % vs. 4.2 % ) , myalgia ( 5.4 % vs. 2.9 % ) , neurocognitive events ( 1.2 % vs. 0.5 % ) , and ophthalmologic events ( 2.9 % vs. 1.9 % ) . In a post hoc analysis , the rate of major adverse cardiovascular events ( death from coronary heart disease , nonfatal myocardial infa rct ion , fatal or nonfatal ischemic stroke , or unstable angina requiring hospitalization ) was lower with alirocumab than with placebo ( 1.7 % vs. 3.3 % ; hazard ratio , 0.52 ; 95 % confidence interval , 0.31 to 0.90 ; nominal P=0.02 ) . CONCLUSIONS Over a period of 78 weeks , alirocumab , when added to statin therapy at the maximum tolerated dose , significantly reduced LDL cholesterol levels . In a post hoc analysis , there was evidence of a reduction in the rate of cardiovascular events with alirocumab . ( Funded by Sanofi and Regeneron Pharmaceuticals ; ODYSSEY LONG TERM Clinical Trials.gov number , NCT01507831 . )",
"BACKGROUND Statin intolerance limits many patients from achieving optimal low-density lipoprotein cholesterol ( LDL-C ) concentrations . Current options for such patients include using a lower but tolerated dose of a statin and adding or switching to ezetimibe or other non-statin therapies . METHODS ODYSSEY ALTERNATIVE ( NCT01709513 ) compared alirocumab with ezetimibe in patients at moderate to high cardiovascular risk with statin intolerance ( unable to tolerate ≥2 statins , including one at the lowest approved starting dose ) due to muscle symptoms . A placebo run-in and statin rechallenge arm were included in an attempt to confirm intolerance . Patients ( n = 361 ) received single-blind subcutaneous ( SC ) and oral placebo for 4 weeks during placebo run-in . Patients reporting muscle-related symptoms during the run-in were to be withdrawn . Continuing patients were r and omized ( 2:2:1 ) to double-blind alirocumab 75 mg SC every 2 weeks ( Q2W ; plus oral placebo ) , ezetimibe 10 mg/d ( plus SC placebo Q2W ) , or atorvastatin 20 mg/d ( rechallenge ; plus SC placebo Q2W ) for 24 weeks . Alirocumab dose was increased to 150 mg Q2W at week 12 depending on week 8 LDL-C values . Primary end point was percent change in LDL-C from baseline to week 24 ( intent-to-treat ) for alirocumab vs ezetimibe . RESULTS Baseline mean ( st and ard deviation ) LDL-C was 191.3 ( 69.3 ) mg/dL ( 5.0 [ 1.8 ] mmol/L ) . Alirocumab reduced mean ( st and ard error ) LDL-C by 45.0 % ( 2.2 % ) vs 14.6 % ( 2.2 % ) with ezetimibe ( mean difference 30.4 % [ 3.1 % ] , P .0001 ) . Skeletal muscle-related events were less frequent with alirocumab vs atorvastatin ( hazard ratio 0.61 , 95 % confidence interval 0.38 - 0.99 , P = .042 ) . CONCLUSIONS Alirocumab produced greater LDL-C reductions than ezetimibe in statin-intolerant patients , with fewer skeletal-muscle adverse events vs atorvastatin ",
"CONTEXT An estimated 10 % to 20 % of patients can not tolerate statins or adequate doses to achieve treatment goals . Plasma proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) binds to low-density lipoprotein ( LDL ) receptors , promoting their degradation and increasing LDL cholesterol levels . In phase 1 studies , a human monoclonal antibody to PCSK9 , AMG145 , was well tolerated and reduced LDL cholesterol levels . OBJECTIVE To assess the efficacy and tolerability of AMG145 in patients with statin intolerance due to muscle-related side effects . DESIGN , SETTING , AND PATIENTS A 12-week , r and omized , double-blind , placebo- and ezetimibe-controlled , dose-ranging study conducted between July 2011 and May 2012 in statin-intolerant adult patients at 33 international sites . INTERVENTION Patients were r and omized equally to 1 of 5 groups : AMG145 alone at doses of 280 mg , 350 mg , or 420 mg ; AMG145 at 420 mg plus 10 mg of ezetimibe ; or 10 mg of ezetimibe plus placebo . AMG145 or placebo was administered subcutaneously every 4 weeks . MAIN OUTCOME MEASURES The primary end point was percentage change from baseline to week 12 in ultracentrifugation-measured LDL cholesterol . Other end points included measures of safety and tolerability of different doses of AMG145 and AMG145 plus ezetimibe . RESULTS Of 236 patients screened , 160 were r and omized ( mean age , 62 years ; 64 % female ; mean baseline LDL cholesterol , 193 mg/dL ) ; all patients had intolerance to 1 or more statins because of muscle-related events . At week 12 , mean changes in LDL cholesterol levels were -67 mg/dL ( -41 % ; 95 % CI , -49 % to -33 % ) for the AMG145 , 280-mg , group ; -70 mg/dL ( -43 % ; 95 % CI , -51 % to -35 % ) for the 350-mg group ; -91 mg/dL ( -51 % ; 95 % CI , -59 % to -43 % ) for the 420-mg group ; and -110 mg/dL ( -63 % ; 95 % CI , -71 % to -55 % ) for the 420-mg/ezetimibe group compared with -14 mg/dL ( -15 % ; 95 % CI , -23 % to -7.0 % ) for the placebo/ezetimibe group ( P serious adverse events were reported with AMG145 ( coronary artery disease , acute pancreatitis , hip fracture , syncope ) . Myalgia was the most common treatment-emergent adverse event during the study , occurring in 5 patients ( 15.6 % ) in the 280-mg group ( n = 32 ) ; 1 patient ( 3.2 % ) in the 350-mg group ( n = 31 ) , 1 patient ( 3.1 % ) in the 420-mg group ( n = 32 ) , 6 patients ( 20.0 % ) receiving 420-mg AMG145/ezetimibe , and 1 patient ( 3.1 % ) receiving placebo/ezetimibe . CONCLUSION In this phase 2 study in statin-intolerant patients , subcutaneous administration of a monoclonal antibody to PCSK9 significantly reduced LDL cholesterol levels and was associated with short-term tolerability . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01375764",
"PURPOSE Animal research and cross-sectional studies suggest that serum lipid concentrations may influence cognitive function , mood , and behavior , but few clinical trials have studied these effects . SUBJECTS AND METHODS In this double-blind investigation , 209 generally healthy adults with a serum low-density-lipoprotein ( LDL ) cholesterol level of 160 mg/dL or higher were r and omly assigned to 6-month treatment with lovastatin ( 20 mg ) or placebo . Assessment s of neuropsychological performance , depression , hostility , and quality of life were conducted at baseline and at the end of the treatment period . Summary effect sizes were estimated as z scores on a st and ard deviation ( SD ) scale . RESULTS Placebo-treated subjects improved between baseline and posttreatment periods on neuropsychological tests in all five performance domains , consistent with the effects of practice on test performance ( all P lovastatin improved only on tests of memory recall ( P = 0.03 ) . Comparisons of the changes in performance between placebo- and lovastatin-treated subjects revealed small , but statistically significant , differences for tests of attention ( z score = 0.18 ; 95 % confidence interval ( CI ) , 0.06 to 0.31 ; P = 0.005 ) and psychomotor speed ( z score = 0.17 ; 95 % CI , 0.05 to 0.28 ; P = 0 . 004 ) that were consistent with greater improvement in the placebo group . Psychological well-being , as measured several ways , was not affected by lovastatin . CONCLUSION Treatment of hypercholesterolemia with lovastatin did not cause psychological distress or substantially alter cognitive function . Treatment did result in small performance decrements on neuropsychological tests of attention and psychomotor speed , the clinical importance of which is uncertain",
"BACKGROUND Statin therapy reduces low-density lipoprotein ( LDL ) cholesterol levels and the risk of cardiovascular events , but whether the addition of ezetimibe , a nonstatin drug that reduces intestinal cholesterol absorption , can reduce the rate of cardiovascular events further is not known . METHODS We conducted a double-blind , r and omized trial involving 18,144 patients who had been hospitalized for an acute coronary syndrome within the preceding 10 days and had LDL cholesterol levels of 50 to 100 mg per deciliter ( 1.3 to 2.6 mmol per liter ) if they were receiving lipid-lowering therapy or 50 to 125 mg per deciliter ( 1.3 to 3.2 mmol per liter ) if they were not receiving lipid-lowering therapy . The combination of simvastatin ( 40 mg ) and ezetimibe ( 10 mg ) ( simvastatin-ezetimibe ) was compared with simvastatin ( 40 mg ) and placebo ( simvastatin monotherapy ) . The primary end point was a composite of cardiovascular death , nonfatal myocardial infa rct ion , unstable angina requiring rehospitalization , coronary revascularization ( ≥30 days after r and omization ) , or nonfatal stroke . The median follow-up was 6 years . RESULTS The median time-weighted average LDL cholesterol level during the study was 53.7 mg per deciliter ( 1.4 mmol per liter ) in the simvastatin-ezetimibe group , as compared with 69.5 mg per deciliter ( 1.8 mmol per liter ) in the simvastatin-monotherapy group ( P The Kaplan-Meier event rate for the primary end point at 7 years was 32.7 % in the simvastatin-ezetimibe group , as compared with 34.7 % in the simvastatin-monotherapy group ( absolute risk difference , 2.0 percentage points ; hazard ratio , 0.936 ; 95 % confidence interval , 0.89 to 0.99 ; P=0.016 ) . Rates of prespecified muscle , gallbladder , and hepatic adverse effects and cancer were similar in the two groups . CONCLUSIONS When added to statin therapy , ezetimibe result ed in incremental lowering of LDL cholesterol levels and improved cardiovascular outcomes . Moreover , lowering LDL cholesterol to levels below previous targets provided additional benefit . ( Funded by Merck ; IMPROVE-IT Clinical Trials.gov number , NCT00202878 . )",
"Background — Cardiovascular events occur among statin-treated patients , albeit at lower rates . Risk factors for this “ residual risk ” have not been studied comprehensively . We aim ed to identify determinants of this risk above and beyond lipid-related risk factors . Methods and Results — A total of 9251 coronary patients with low-density lipoprotein cholesterol atorvastatin 10 or 80 mg/d in the Treating to New Targets ( TNT ) study had complete on-treatment 1-year lipid data . Median follow-up was 4.9 years . The primary end point was major cardiovascular events ( n=729 ) : coronary death , nonfatal myocardial infa rct ion , resuscitation after cardiac arrest , or fatal or nonfatal stroke . Multivariable determinants of increased risk were older age ( adjusted hazard ratio [ aHR ] , 1.13 per 1 SD [ 8.8 years ] ; 95 % confidence interval [ CI ] , 1.04–1.23 ) , increased body mass index ( aHR , 1.09 ; 95 % CI , 1.02–1.17 per 4.5 kg/m2 ) , male sex ( aHR , 1.33 ; 95 % CI , 1.07–1.65 ) , hypertension ( aHR , 1.38 ; 95 % CI , 1.17–1.63 ) , diabetes mellitus ( aHR , 1.33 ; 95 % CI , 1.11–1.60 ) , baseline apolipoprotein B ( aHR , 1.19 ; 95 % CI , 1.11–1.28 per 19 mg/dL ) , and blood urea nitrogen ( aHR , 1.10 ; 95 % CI , 1.03–1.17 per 4.9 mg/dL ) , in addition to current smoking , prior cardiovascular disease , and calcium channel blocker use . Determinants of decreased risk were high-dose statin ( aHR , 0.82 ; 95 % CI , 0.70–0.94 ) , aspirin use ( aHR , 0.67 ; 95 % CI , 0.56–0.81 ) , and baseline apolipoprotein A-I ( aHR , 0.91 ; 95 % CI , 0.84–0.99 per 25 mg/dL ) . On-treatment 1-year lipids or apolipoproteins were not additionally associated with risk in multivariable models . Known baseline variables performed moderately well in discriminating future cases from noncases ( Harrell c index=0.679 ) . Conclusions — Determinants of residual risk in statin-treated secondary prevention patients included lipid-related and nonlipid factors such as baseline apolipoproteins , increased body mass index , smoking , hypertension , and diabetes mellitus . A multifaceted prevention approach should be underscored to address this risk . Clinical Trial Registration — URL : http:// clinical trials.gov . Unique identifier : NCT00327691",
"Observational studies have given conflicting results about the effect of statins in preventing dementia and cognitive decline . Moreover , observational studies are subject to prescription bias , making it hard to draw definite conclusions from them . R and omized controlled trials are therefore the preferred study design to investigate the association between statins and cognition . Here we present detailed cognitive outcomes from the r and omized placebo-controlled PROspect i ve Study of Pravastatin in the Elderly at Risk ( PROSPER ) . Cognitive function was assessed repeatedly in all 5,804 PROSPER participants at six different time points during the study using four neuropsychological performance tests . After a mean follow-up period of 42 months , no difference in cognitive decline at any of the cognitive domains was found in subjects treated with pravastatin compared to placebo ( all p > 0.05 ) . Pravastatin treatment in old age did not affect cognitive decline during a 3 year follow-up period . Employing statin therapy in the elderly in an attempt to prevent cognitive decline therefore seems to be futile",
"IMPORTANCE In phase 2 studies , evolocumab , a fully human monoclonal antibody to PCSK9 , reduced LDL-C levels in patients receiving statin therapy . OBJECTIVE To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate- vs high-intensity statin . DESIGN , SETTING , AND PATIENTS Phase 3 , 12-week , r and omized , double-blind , placebo- and ezetimibe-controlled study conducted between January and December of 2013 in patients with primary hypercholesterolemia and mixed dyslipidemia at 198 sites in 17 countries . INTERVENTIONS Patients ( n = 2067 ) were r and omized to 1 of 24 treatment groups in 2 steps . Patients were initially r and omized to a daily , moderate-intensity ( atorvastatin [ 10 mg ] , simvastatin [ 40 mg ] , or rosuvastatin [ 5 mg ] ) or high-intensity ( atorvastatin [ 80 mg ] , rosuvastatin [ 40 mg ] ) statin . After a 4-week lipid-stabilization period , patients ( n = 1899 ) were r and omized to compare evolocumab ( 140 mg every 2 weeks or 420 mg monthly ) with placebo ( every 2 weeks or monthly ) or ezetimibe ( 10 mg or placebo daily ; atorvastatin patients only ) when added to statin therapies . MAIN OUTCOMES AND MEASURES Percent change from baseline in low-density lipoprotein cholesterol ( LDL-C ) level at the mean of weeks 10 and 12 and at week 12 . RESULTS Evolocumab reduced LDL-C levels by 66 % ( 95 % CI , 58 % to 73 % ) to 75 % ( 95 % CI , 65 % to 84 % ) ( every 2 weeks ) and by 63 % ( 95 % CI , 54 % to 71 % ) to 75 % ( 95 % CI , 67 % to 83 % ) ( monthly ) vs placebo at the mean of weeks 10 and 12 in the moderate- and high-intensity statin-treated groups ; the LDL-C reductions at week 12 were comparable . For moderate-intensity statin groups , evolocumab every 2 weeks reduced LDL-C from a baseline mean of 115 to 124 mg/dL to an on-treatment mean of 39 to 49 mg/dL ; monthly evolocumab reduced LDL-C from a baseline mean of 123 to 126 mg/dL to an on-treatment mean of 43 to 48 mg/dL. For high-intensity statin groups , evolocumab every 2 weeks reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 35 to 38 mg/dL ; monthly evolocumab reduced LDL-C from a baseline mean of 89 to 94 mg/dL to an on-treatment mean of 33 to 35 mg/dL. Adverse events were reported in 36 % , 40 % , and 39 % of evolocumab- , ezetimibe- , and placebo-treated patients , respectively . The most common adverse events in evolocumab-treated patients were back pain , arthralgia , headache , muscle spasms , and pain in extremity ( all patients with primary hypercholesterolemia and mixed dyslipidemia , evolocumab added to moderate- or high-intensity statin therapy result ed in additional LDL-C lowering . Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01763866",
"BACKGROUND Pharmacologic inhibitors of proprotein convertase subtilisin-kexin type 9 ( PCSK9 ) are being evaluated in clinical trials for the treatment of cardiovascular disease . The effect of lowering low-density lipoprotein ( LDL ) cholesterol levels by inhibiting PCSK9 on the risk of cardiovascular events or diabetes is unknown . METHODS We used genetic scores consisting of independently inherited variants in the genes encoding PCSK9 and 3-hydroxy-3-methylglutaryl-coenzyme A reductase ( HMGCR ; the target of statins ) as instruments to r and omly assign 112,772 participants from 14 studies , with 14,120 cardiovascular events and 10,635 cases of diabetes , to groups according to the number of LDL cholesterol-lowering alleles that they had inherited . We compared the effects of lower LDL cholesterol levels that were mediated by variants in PCSK9 , HMGCR , or both on the risk of cardiovascular events and the risk of diabetes . RESULTS Variants in PCSK9 and HMGCR were associated with nearly identical protective effects on the risk of cardiovascular events per decrease of 10 mg per deciliter ( 0.26 mmol per liter ) in the LDL cholesterol level : odds ratio for cardiovascular events , 0.81 ( 95 % confidence interval [ CI ] , 0.74 to 0.89 ) for PCSK9 and 0.81 ( 95 % CI , 0.72 to 0.90 ) for HMGCR . Variants in these two genes were also associated with very similar effects on the risk of diabetes : odds ratio for each 10 mg per deciliter decrease in LDL cholesterol , 1.11 ( 95 % CI , 1.04 to 1.19 ) for PCSK9 and 1.13 ( 95 % CI , 1.06 to 1.20 ) for HMGCR . The increased risk of diabetes was limited to persons with impaired fasting glucose levels for both scores and was lower in magnitude than the protective effect against cardiovascular events . When present together , PCSK9 and HMGCR variants had additive effects on the risk of both cardiovascular events and diabetes . CONCLUSIONS In this study , variants in PCSK9 had approximately the same effect as variants in HMGCR on the risk of cardiovascular events and diabetes per unit decrease in the LDL cholesterol level . The effects of these variants were independent and additive . ( Funded by the Medical Research Council and the National Heart , Lung , and Blood Institute . )",
"Background The PCSK9 antibody alirocumab ( 75 mg every 2 weeks ; Q2W ) as monotherapy reduced low‐density lipoprotein‐cholesterol ( LDL‐C ) levels by 47 % . Because the option of a monthly dosing regimen is convenient , ODYSSEY CHOICE II evaluated alirocumab 150 mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin ( majority with statin‐associated muscle symptoms ) , receiving treatment with fenofibrate , ezetimibe , or diet alone . Methods and Results Patients were r and omly assigned to placebo , alirocumab 150 mg Q4W or 75 mg Q2W ( calibrator arm ) , with dose adjustment to 150 mg Q2W at week ( W ) 12 if W8 predefined LDL‐C target levels were not met . The primary efficacy endpoint was LDL‐C percentage change from baseline to W24 . Mean baseline LDL‐C levels were 163.9 mg/dL ( alirocumab 150 mg Q4W , n=59 ) , 154.5 mg/dL ( alirocumab 75 mg Q2W , n=116 ) , and 158.5 mg/dL ( placebo , n=58 ) . In the alirocumab 150 mg Q4W and 75 mg Q2W groups ( 49.1 % and 36.0 % of patients received dose adjustment , respectively ) , least‐squares mean LDL‐C changes from baseline to W24 were −51.7 % and −53.5 % , respectively ( placebo [ + 4.7 % ] ; both groups P of alirocumab‐treated patients achieved their LDL‐C targets at W24 . Treatment‐emergent adverse events occurred in 77.6 % ( alirocumab 150 mg Q4W ) , 73.0 % ( alirocumab 75 mg Q2W ) , and 63.8 % ( placebo ) of patients , with injection‐site reactions among the most common treatment‐emergent adverse events . Conclusions Alirocumab 150 mg Q4W can be considered in patients not on statin with inadequately controlled hypercholesterolemia as a convenient option for lowering LDL‐C. Clinical Trial Registration URL : http://www . clinical trials.gov . Unique identifier : NCT02023879",
"BACKGROUND Evolocumab , a monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , significantly reduced low-density lipoprotein ( LDL ) cholesterol levels in phase 2 studies . We conducted a phase 3 trial to evaluate the safety and efficacy of 52 weeks of treatment with evolocumab . METHODS We stratified patients with hyperlipidemia according to the risk categories outlined by the Adult Treatment Panel III of the National Cholesterol Education Program . On the basis of this classification , patients were started on background lipid-lowering therapy with diet alone or diet plus atorvastatin at a dose of 10 mg daily , atorvastatin at a dose of 80 mg daily , or atorvastatin at a dose of 80 mg daily plus ezetimibe at a dose of 10 mg daily , for a run-in period of 4 to 12 weeks . Patients with an LDL cholesterol level of 75 mg per deciliter ( 1.9 mmol per liter ) or higher were then r and omly assigned in a 2:1 ratio to receive either evolocumab ( 420 mg ) or placebo every 4 weeks . The primary end point was the percent change from baseline in LDL cholesterol , as measured by means of ultracentrifugation , at week 52 . RESULTS Among the 901 patients included in the primary analysis , the overall least-squares mean ( ±SE ) reduction in LDL cholesterol from baseline in the evolocumab group , taking into account the change in the placebo group , was 57.0±2.1 % ( P atorvastatin , and 48.5±5.2 % among those who received a combination of 80 mg of atorvastatin and 10 mg of ezetimibe ( P comparisons ) . Evolocumab treatment also significantly reduced levels of apolipoprotein B , non-high-density lipoprotein cholesterol , lipoprotein(a ) , and triglycerides . The most common adverse events were nasopharyngitis , upper respiratory tract infection , influenza , and back pain . CONCLUSIONS At 52 weeks , evolocumab added to diet alone , to low-dose atorvastatin , or to high-dose atorvastatin with or without ezetimibe significantly reduced LDL cholesterol levels in patients with a range of cardiovascular risks . ( Funded by Amgen ; DESCARTES Clinical Trials.gov number , NCT01516879 . )",
"BACKGROUND Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) increases serum LDL-cholesterol ( LDL-C ) concentrations . We assessed the effects of AMG 145 , a human monoclonal antibody against PCSK9 , in patients with hypercholesterolaemia in the absence of concurrent lipid-lowering treatment . METHODS In a phase 2 trial done at 52 centres in Europe , the USA , Canada , and Australia , patients ( aged 18 - 75 years ) with serum LDL-C concentrations of 2·6 mmol/L or greater but less than 4·9 mmol/L were r and omly assigned equally through an interactive voice response system to subcutaneous injections of AMG 145 70 mg , 105 mg , or 140 mg , or placebo every 2 weeks ; subcutaneous AMG 145 280 mg , 350 mg , or 420 mg or placebo every 4 weeks ; or oral ezetimibe 10 mg/day . The primary endpoint was percentage change from baseline in LDL-C concentration at week 12 . Analysis was by modified intention to treat . Study personnel and patients were masked to treatment assignment of AMG 145 or placebo . Ezetimibe assignment was open label . This trial is registered with Clinical Trials.gov , number NCT01375777 . FINDINGS 406 patients were assigned to AMG 145 70 mg ( n=45 ) , 105 mg ( n=46 ) , or 140 mg ( n=45 ) every 2 weeks ; AMG 145 280 mg ( n=45 ) , 350 mg ( n=45 ) , or 420 mg ( n=45 ) every 4 weeks ; placebo every 2 weeks ( n=45 ) or every 4 weeks ( n=45 ) ; or ezetimibe ( n=45 ) . AMG 145 significantly reduced LDL-C concentrations in all dose groups ( mean baseline LDL-C concentration 3·7 mmol/L [ SD 0·6 ] ; changes from baseline with every 2 weeks AMG 145 70 mg -41·0 % [ 95 % CI -46·2 to -35·8 ] ; 105 mg -43·9 % [ -49·0 to -38·7 ] ; 140 mg -50·9 % [ -56·2 to -45·7 ] ; every 4 weeks AMG 145 280 mg -39·0 % [ -44·1 to -34·0 ] ; 350 mg -43·2 % [ -48·3 to -38·1 ] ; 420 mg -48·0 % [ -53·1 to -42·9 ] ; placebo every 2 weeks -3·7 % [ -9·0 to 1·6 ] ; placebo every 4 weeks 4·5 % [ -0·7 to 9·8 ] ; and ezetimibe -14·7 % [ -18·6 to -10·8 ] ; p placebo or ezetimibe ) . Treatment-emergent adverse events occurred in 136 ( 50 % ) of 271 patients in the AMG 145 groups , 41 ( 46 % ) of 90 patients in the placebo groups , and 26 ( 58 % ) of 45 patients in the ezetimibe group ; no deaths or serious treatment-related adverse events were reported . INTERPRETATION The results of our study support the further assessment of AMG 145 in long-term studies with larger and more diverse population s including patients with documented statin intolerance . FUNDING Amgen",
"Statins are the accepted st and ard for lowering low‐density lipoprotein cholesterol ( LDL‐C ) . However , 5 % to 10 % of statin‐treated patients report intolerance , mostly due to muscle‐related adverse effects . Challenges exist to objective identification of statin‐intolerant patients . Evolocumab is a monoclonal antibody that binds proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , result ing in marked LDL‐C reduction . We report the design of Goal Achievement After Utilizing an Anti‐PCSK9 Antibody in Statin‐Intolerant Subjects 3 ( GAUSS‐3 ) , a phase 3 , multicenter , r and omized , double‐blind , ezetimibe‐controlled study to compare effectiveness of 24 weeks of evolocumab 420 mg monthly vs ezetimibe 10 mg daily in hypercholesterolemic patients unable to tolerate an effective statin dose . The study incorporates a novel atorvastatin‐controlled , double‐blind , crossover phase to objective ly identify statin intolerance . Eligible patients had LDL‐C above the National Cholesterol Education Project Adult Treatment Panel III target level for the appropriate coronary heart disease risk category and were unable to tolerate ≥3 statins or 2 statins ( one of which was atorvastatin ≤10 mg/d ) or had a history of marked creatine kinase elevation accompanied by muscle symptoms while on 1 statin . This trial has 2 co‐ primary endpoints : mean percent change from baseline in LDL‐C at weeks 22 and 24 and percent change from baseline in LDL‐C at week 24 . Key secondary efficacy endpoints include change from baseline in LDL‐C , percent of patients attaining LDL‐C and percent change from baseline in total cholesterol , non – high‐density lipoprotein cholesterol , and apolipoprotein B. Recruitment of 511 patients was completed on November 28 , 2014",
"BACKGROUND The ODYSSEY Japan study was design ed to demonstrate the reduction in low-density lipoprotein cholesterol ( LDL-C ) by alirocumab as add-on to existing lipid-lowering therapy in Japanese patients with heterozygous familial hypercholesterolemia ( heFH ) or non-FH at high cardiovascular risk who require additional pharmacological management to achieve their LDL-C treatment goal ( METHODS AND RESULTS This r and omized , double-blind , parallel-group , 52-week study was conducted in Japan . Patients ( n=216 ) with heFH , non-FH at high cardiovascular risk with coronary disease , or classified as category III were enrolled . The prespecified safety analysis was done after the last patient completed 52 weeks . Patients were r and omized ( 2:1 , alirocumab : placebo ) with stratification for heFH to s.c . alirocumab ( 75 mg every 2 weeks [ Q2 W ] with increase to 150 mg if week 8 LDL-C ≥2.6/3.1 mmol/L ) or placebo for 52 weeks plus stable statin therapy . At week 24 , mean±SE change in LDL-C from baseline was -62.5±1.3 % in the alirocumab group and 1.6±1.8 % in the placebo group ( difference , -64.1±2.2 % ; P ( alirocumab , -62.5±1.4 % ; placebo , -3.6±1.9 % ) . No patterns were evident between treatment groups for adverse events at 52 weeks . CONCLUSIONS In high-risk Japanese patients with hypercholesterolemia on stable statin therapy , alirocumab markedly reduced LDL-C vs. placebo and was well tolerated over 52 weeks . ( Circ J 2016 ; 80 : 1980 - 1987 )",
"PURPOSE In our initial study of the potential effects of cholesterol-lowering interventions on cognitive functioning , treatment with lovastatin as compared with placebo caused performance decrements on several neuropsychological tests , whereas scores on other tests were unaffected . The current study was design ed to confirm and extend those findings . METHODS The study comprised 308 hypercholesterolemic adults between 35 and 70 years of age . Employing a r and omized double-blind design , we assigned participants to daily treatment with placebo , 10 mg of simvastatin , or 40 mg of simvastatin for 6 months . A neuropsychological test battery was administered to assess cognitive functioning at baseline and at the end of the treatment period . RESULTS A total of 283 subjects completed the study : 94 subjects on placebo , 96 taking 10 mg of simvastatin , and 93 taking 40 mg of simvastatin . Compared with placebo , decremental effects of simvastatin treatment were found on tests previously observed to be sensitive to statins ( P = 0.008 ; difference in summary z scores = 0.18 ; 95 % confidence interval [ CI ] : 0.07 to 0.29 ) and on tests not previously administered ( P = 0.04 ; difference in summary z scores = 0.17 ; 95 % CI : 0.05 to 0.29 ) , but not on tests previously observed to be insensitive to statins ( P = 0.84 ; difference in summary z scores = 0.02 ; 95 % CI : -0.07 to 0.10 ) . For the three tests specifically affected by simvastatin , effects on cognitive performance were small , manifest only as failure to improve during the 6 months of treatment ( compared with placebo ) , and were confounded by baseline differences on one test . CONCLUSION This study provides partial support for minor decrements in cognitive functioning with statins . Whether such effects have any long-term sequelae or occur with other cholesterol-lowering interventions is not known",
"OBJECTIVE To compare lipid-lowering efficacy of adding alirocumab to rosuvastatin versus other treatment strategies ( NCT01730053 ) . METHODS Patients receiving baseline rosuvastatin regimens ( 10 or 20 mg ) were r and omized to : add-on alirocumab 75 mg every-2-weeks ( Q2W ) ( 1-mL subcutaneous injection via pre-filled pen ) ; add-on ezetimibe 10 mg/day ; or double-dose rosuvastatin . Patients had cardiovascular disease ( CVD ) and low-density lipoprotein cholesterol ( LDL-C ) ≥70 mg/dL ( 1.8 mmol/L ) or CVD risk factors and LDL-C ≥100 mg/dL ( 2.6 mmol/L ) . In the alirocumab group , dose was blindly increased at Week 12 to 150 mg Q2W ( also 1-mL volume ) in patients not achieving their LDL-C target . Primary endpoint was percent change in calculated LDL-C from baseline to 24 weeks ( intent-to-treat ) . RESULTS 305 patients were r and omized . In the baseline rosuvastatin 10 mg group , significantly greater LDL-C reductions were observed with add-on alirocumab ( -50.6 % ) versus ezetimibe ( -14.4 % ; p baseline rosuvastatin 20 mg group , LDL-C reduction with add-on alirocumab was -36.3 % compared with -11.0 % with ezetimibe and -15.9 % with double-dose rosuvastatin ( p = 0.0136 and 0.0453 , respectively ; pre-specified threshold for significance p % alirocumab patients were maintained on 75 mg Q2W . Of alirocumab-treated patients , 84.9 % and 66.7 % in the baseline rosuvastatin 10 and 20 mg groups , respectively , achieved risk-based LDL-C targets . Treatment-emergent adverse events occurred in 56.3 % of alirocumab patients versus 53.5 % ezetimibe and 67.3 % double-dose rosuvastatin ( pooled data ) . CONCLUSIONS The addition of alirocumab to rosuvastatin provided incremental LDL-C lowering versus adding ezetimibe or doubling the rosuvastatin dose",
"Evolocumab ( AMG 145 ) , a fully human monoclonal antibody against PCSK9 , significantly reduced low-density lipoprotein cholesterol ( LDL-C ) levels in phase 2 and 3 studies . This phase 3 study evaluated the efficacy and safety of evolocumab plus atorvastatin in Japanese patients with hyperlipidemia or mixed dyslipidemia and high cardiovascular risk . Patients were r and omized to atorvastatin 5 or 20 mg/day for 4 weeks . Subsequently , patients underwent second r and omization to evolocumab 140 mg biweekly ( Q2W ) or 420 mg monthly ( QM ) or placebo Q2W or QM . Co primary end points were % change from baseline in LDL-C at week 12 and mean of weeks 10 and 12 . Secondary end points included change and % change in other lipids and proportion of patients reaching LDL-C 70 mg/dl . Adverse events and laboratory values were recorded . Four hundred four patients were r and omized to study drug . At baseline , the mean ( SD ) age was 61 ( 10 ) years ( placebo ) and 62 ( 11 ) years ( evolocumab ) ; 39 % and 40 % were women ; 14 % and 12 % had cerebrovascular or peripheral arterial disease ; and 51 % and 47 % had diabetes . At entry , mean ( SD ) calculated LDL-C was 128 ( 23 ) mg/dL ; after stabilization on atorvastatin 5 and 20 mg/day , baseline LDL-C levels were 118 ( 35 ) and 94 ( 24 ) mg/dL , respectively . Mean LDL-C reductions at week 12 for evolocumab versus placebo ranged from 67 % to 76 % . No imbalances were observed in adverse events between treatment groups . Efficacy and safety for Q2W or QM evolocumab dosing were similar . In conclusion , in high-risk Japanese patients receiving stable statin therapy , evolocumab markedly reduced LDL-C and was well tolerated",
"OBJECTIVES The primary objective of this study was to evaluate the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy of 5 SAR236553/REGN727 ( SAR236553 ) dosing regimens versus placebo at week 12 in patients with LDL-C ≥100 mg/dl on stable atorvastatin therapy . Secondary objectives included evaluation of effects on other lipid parameters and the attainment of LDL-C treatment goals of SAR236553 is a fully human monoclonal antibody to PCSK9 . METHODS This double-blind , parallel-group , placebo-controlled trial r and omized 183 patients with LDL-C ≥100 mg/dl ( 2.59 mmol/l ) on stable-dose atorvastatin 10 , 20 , or 40 mg for ≥6 weeks to : subcutaneous placebo every 2 weeks ( Q2W ) ; SAR236553 50 , 100 , or 150 mg Q2W ; or SAR236553 200 or 300 mg every 4 weeks ( Q4W ) , alternating with placebo for a total treatment period of 12 weeks . RESULTS SAR236553 demonstrated a clear dose-response relationship with respect to percentage LDL-C lowering for both Q2W and Q4W administration : 40 % , 64 % , and 72 % with 50 , 100 , and 150 mg Q2W , respectively , and 43 % and 48 % with 200 and 300 mg Q4W . LDL-C reduction with placebo at week 12 was 5 % . SAR236553 also substantially reduced non-high-density lipoprotein cholesterol , apolipoprotein B , and lipoprotein(a ) . SAR236553 was generally well tolerated . One patient on SAR236553 experienced a serious adverse event of leukocytoclastic vasculitis . CONCLUSIONS When added to atorvastatin , PCSK9 inhibition with SAR236553 further reduces LDL-C by 40 % to 72 % . These additional reductions are both dose- and dosing frequency-dependent . ( Efficacy and Safety Evaluation of SAR236553 [ REGN727 ] in Patients With Primary Hypercholesterolemia and LDL-cholesterol on Stable Atorvastatin Therapy ; NCT01288443 )",
"BACKGROUND In view of evidence that statin therapy increases risk of diabetes , the balance of benefit and risk of these drugs in primary prevention has become controversial . We undertook an analysis of participants from the JUPITER trial to address the balance of vascular benefits and diabetes hazard of statin use . METHODS In the r and omised , double-blind JUPITER trial , 17,603 men and women without previous cardiovascular disease or diabetes were r and omly assigned to rosuvastatin 20 mg or placebo and followed up for up to 5 years for the primary endpoint ( myocardial infa rct ion , stroke , admission to hospital for unstable angina , arterial revascularisation , or cardiovascular death ) and the protocol -prespecified secondary endpoints of venous thromboembolism , all-cause mortality , and incident physician-reported diabetes . In this analysis , participants were stratified on the basis of having none or at least one of four major risk factors for developing diabetes : metabolic syndrome , impaired fasting glucose , body-mass index 30 kg/m(2 ) or higher , or glycated haemoglobin A(1c ) greater than 6 % . The trial is registered at Clinical Trials.gov , NCT00239681 . FINDINGS Trial participants with one or more major diabetes risk factor ( n=11,508 ) were at higher risk of developing diabetes than were those without a major risk factor ( n=6095 ) . In individuals with one or more risk factors , statin allocation was associated with a 39 % reduction in the primary endpoint ( hazard ratio [ HR ] 0·61 , 95 % CI 0·47 - 0·79 , p=0·0001 ) , a 36 % reduction in venous thromboembolism ( 0·64 , 0·39 - 1·06 , p=0·08 ) , a 17 % reduction in total mortality ( 0·83 , 0·64 - 1·07 , p=0·15 ) , and a 28 % increase in diabetes ( 1·28 , 1·07 - 1·54 , p=0·01 ) . Thus , for those with diabetes risk factors , a total of 134 vascular events or deaths were avoided for every 54 new cases of diabetes diagnosed . For trial participants with no major diabetes risk factors , statin allocation was associated with a 52 % reduction in the primary endpoint ( HR 0·48 , 95 % CI 0·33 - 0·68 , p=0·0001 ) , a 53 % reduction in venous thromboembolism ( 0·47 , 0·21 - 1·03 , p=0·05 ) , a 22 % reduction in total mortality ( 0·78 , 0·59 - 1·03 , p=0·08 ) , and no increase in diabetes ( 0·99 , 0·45 - 2·21 , p=0·99 ) . For such individuals , a total of 86 vascular events or deaths were avoided with no new cases of diabetes diagnosed . In analysis limited to the 486 participants who developed diabetes during follow-up ( 270 on rosuvastatin vs 216 on placebo ; HR 1·25 , 95 % CI 1·05 - 1·49 , p=0·01 ) , the point estimate of cardiovascular risk reduction associated with statin therapy ( HR 0·63 , 95 % CI 0·25 - 1·60 ) was consistent with that for the trial as a whole ( 0·56 , 0·46 - 0·69 ) . By comparison with placebo , statins accelerated the average time to diagnosis of diabetes by 5·4 weeks ( 84·3 [ SD 47·8 ] weeks on rosuvastatin vs 89·7 [ 50·4 ] weeks on placebo ) . INTERPRETATION In the JUPITER primary prevention trial , the cardiovascular and mortality benefits of statin therapy exceed the diabetes hazard , including in participants at high risk of developing diabetes . FUNDING AstraZeneca",
"OBJECTIVES The aim of this study was to compare biweekly and monthly evolocumab with placebo and oral ezetimibe in patients with hypercholesterolemia in a phase III trial . BACKGROUND Evolocumab , a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , significantly reduced LDL-C in phase II trials . METHODS Patients 18 to 80 years of age with fasting low-density lipoprotein cholesterol ( LDL-C ) ≥100 and ( 1:1:1:1:2:2 ) to oral placebo and subcutaneous ( SC ) placebo biweekly ; oral placebo and SC placebo monthly ; ezetimibe and SC placebo biweekly ; ezetimibe and SC placebo monthly ; oral placebo and evolocumab 140 mg biweekly ; or oral placebo and evolocumab 420 mg monthly . RESULTS A total of 614 patients were r and omized and administered doses . Evolocumab treatment reduced LDL-C from baseline , on average , by 55 % to 57 % more than placebo and 38 % to 40 % more than ezetimibe ( p comparisons ) . Evolocumab treatment also favorably altered other lipoprotein levels . Treatment-emergent adverse events ( AEs ) , muscle-related AEs , and laboratory abnormalities were comparable across treatment groups . CONCLUSIONS In the largest monotherapy trial using a PCSK9 inhibitor to date , evolocumab yielded significant LDL-C reductions compared with placebo or ezetimibe and was well tolerated in patients with hypercholesterolemia . ( Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 [ MENDEL-2 ] ; NCT01763827 )",
"BACKGROUND Heterozygous familial hypercholesterolaemia is characterised by low cellular uptake of LDL cholesterol , increased plasma LDL cholesterol concentrations , and premature cardiovascular disease . Despite intensive statin therapy , with or without ezetimibe , many patients are unable to achieve recommended target levels of LDL cholesterol . We investigated the effect of PCSK9 inhibition with evolocumab ( AMG 145 ) on LDL cholesterol in patients with this disorder . METHODS This multicentre , r and omised , double-blind , placebo-controlled trial was undertaken at 39 sites ( most of which were specialised lipid clinics , mainly attached to academic institutions ) in Australia , Asia , Europe , New Zeal and , North America , and South Africa between Feb 7 and Dec 19 , 2013 . 331 eligible patients ( 18 - 80 years of age ) , who met clinical criteria for heterozygous familial hypercholesterolaemia and were on stable lipid-lowering therapy for at least 4 weeks , with a fasting LDL cholesterol concentration of 2·6 mmol/L or higher , were r and omly allocated in a 2:2:1:1 ratio to receive subcutaneous evolocumab 140 mg every 2 weeks , evolocumab 420 mg monthly , or subcutaneous placebo every 2 weeks or monthly for 12 weeks . R and omisation was computer generated by the study sponsor , implemented by a computerised voice interactive system , and stratified by LDL cholesterol concentration at screening ( higher or lower than 4·1 mmol/L ) and by baseline ezetimibe use ( yes/no ) . Patients , study personnel , investigators , and Amgen study staff were masked to treatment assignments within dosing frequency groups . The co primary endpoints were percentage change from baseline in LDL cholesterol at week 12 and at the mean of weeks 10 and 12 , analysed by intention-to-treat . This trial is registered with Clinical Trials.gov , number NCT01763918 . FINDINGS Of 415 screened patients , 331 were eligible and were r and omly assigned to the four treatment groups : evolocumab 140 mg every 2 weeks ( n=111 ) , evolocumab 420 mg monthly ( n=110 ) , placebo every 2 weeks ( n=55 ) , or placebo monthly ( n=55 ) . 329 patients received at least one dose of study drug . Compared with placebo , evolocumab at both dosing schedules led to a significant reduction in mean LDL cholesterol at week 12 ( every-2-weeks dose : 59·2 % reduction [ 95 % CI 53·4 - 65·1 ] , monthly dose : 61·3 % reduction [ 53·6 - 69·0 ] ; both p ] ; both p ) . Evolocumab was well tolerated , with rates of adverse events similar to placebo . The most common adverse events occurring more frequently in the evolocumab-treated patients than in the placebo groups were nasopharyngitis ( in 19 patients [ 9 % ] vs five [ 5 % ] in the placebo group ) and muscle-related adverse events ( ten patients [ 5 % ] vs 1 [ 1 % ] ) . INTERPRETATION In patients with heterozygous familial hypercholesterolaemia , evolocumab administered either 140 mg every 2 weeks or 420 mg monthly was well tolerated and yielded similar and rapid 60 % reductions in LDL cholesterol compared with placebo . FUNDING Amgen",
"BACKGROUND Homozygous familial hypercholesterolaemia is a rare , serious disorder caused by very low or absent plasma clearance of LDL , substantially raised LDL cholesterol , and accelerated development of cardiovascular disease . Conventional lipid-lowering treatments are modestly effective . Evolocumab , a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , reduced LDL cholesterol by 16 % in a pilot study . We now report results with evolocumab in a r and omised , double-blind , placebo-controlled phase 3 trial . METHODS This r and omised , double-blind , placebo-controlled phase 3 trial was undertaken at 17 sites in ten countries in North America , Europe , the Middle East , and South Africa . 50 eligible patients ( aged ≥12 years ) with homozygous familial hypercholesterolaemia , on stable lipid-regulating therapy for at least 4 weeks , and not receiving lipoprotein apheresis , were r and omly allocated by a computer-generated r and omisation sequence in a 2:1 ratio to receive subcutaneous evolocumab 420 mg or placebo every 4 weeks for 12 weeks . R and omisation was stratified by LDL cholesterol at screening ( computerised interactive voice-response system . Patients , study personnel , and the funder were masked to treatment and to the efficacy results by the central laboratory not returning LDL cholesterol or any lipid results to the clinical sites after the baseline visit . The primary endpoint was percentage change in ultracentrifugation LDL cholesterol from baseline at week 12 compared with placebo , analysed by intention-to-treat . This trial is registered with Clinical Trials.gov , number NCT01588496 . FINDINGS Of the 50 eligible patients r and omly assigned to the two treatment groups , 49 actually received the study drug and completed the study ( 16 in the placebo group and 33 in the evolocumab group ) . Compared with placebo , evolocumab significantly reduced ultracentrifugation LDL cholesterol at 12 weeks by 30·9 % ( 95 % CI -43·9 % to -18·0 % ; p events occurred in ten ( 63 % ) of 16 patients in the placebo group and 12 ( 36 % ) of 33 in the evolocumab group . No serious clinical or laboratory adverse events occurred , and no anti-evolocumab antibody development was detected during the study . INTERPRETATION In patients with homozygous familial hypercholesterolaemia receiving stable background lipid-lowering treatment and not on apheresis , evolocumab 420 mg administered every 4 weeks was well tolerated and significantly reduced LDL cholesterol compared with placebo . FUNDING Amgen",
"We assessed the safety and tolerability of ascending single doses of alirocumab in healthy Japanese subjects and evaluated the effect of alirocumab at 3 doses ( 50 , 75 , 150 mg ) on low-density lipoprotein cholesterol ( LDL-C ) reduction in patients with primary hypercholesterolemia on atorvastatin . A r and omized , single ascending-dose study of alirocumab ( 100 , 150 , 250 , or 300 mg ) or placebo ( 3:1 ratio ) , administered subcutaneously , was conducted in 32 healthy Japanese men . The phase 2 , r and omized , double-blind , placebo-controlled , parallel-group study was performed in patients with primary hypercholesterolemia ( defined as calculated LDL-C ≥100 mg/dl [ 2.6 mmol/l ] ) who were on a stable dose of atorvastatin ( 5 to 20 mg ) . Patients were r and omized to alirocumab ( 50 , 75 , or 150 mg ) or placebo ( in single 1.0-ml injection volumes ) administered every 2 weeks ( Q2W ) for 12 weeks ; the primary outcome was the mean percent change in calculated LDL-C from baseline to week 12 . Single subcutaneous administration of alirocumab in healthy subjects was well tolerated over 15 weeks and result ed in highest mean percent reductions in LDL-C from baseline of approximately 40 % to 60 % . In the multiple-dose study , least-square mean ( SE ) changes in calculated LDL-C concentrations from baseline to week 12 were -54.8 % ( 3.1 % ) for alirocumab 50 mg , -62.3 % ( 3.1 % ) for alirocumab 75 mg , and -71.7 % ( 3.1 % ) for alirocumab 150 mg , with a least-square mean ( SE ) difference versus placebo of -52.2 % ( 4.3 % ) , -59.6 % ( 4.3 % ) , and -69.1 % ( 4.3 % ) , respectively ( all p conclusion , alirocumab was well tolerated and significantly reduced LDL-C concentrations in Japanese patients with primary hypercholesterolemia on atorvastatin",
"Importance Reducing levels of low-density lipoprotein cholesterol ( LDL-C ) with intensive statin therapy reduces progression of coronary atherosclerosis in proportion to achieved LDL-C levels . Proprotein convertase subtilisin kexin type 9 ( PCSK9 ) inhibitors produce incremental LDL-C lowering in statin-treated patients ; however , the effects of these drugs on coronary atherosclerosis have not been evaluated . Objective To determine the effects of PCSK9 inhibition with evolocumab on progression of coronary atherosclerosis in statin-treated patients . Design , Setting , and Participants The GLAGOV multicenter , double-blind , placebo-controlled , r and omized clinical trial ( enrollment May 3 , 2013 , to January 12 , 2015 ) conducted at 197 academic and community hospitals in North America , Europe , South America , Asia , Australia , and South Africa and enrolling 968 patients presenting for coronary angiography . Interventions Participants with angiographic coronary disease were r and omized to receive monthly evolocumab ( 420 mg ) ( n = 484 ) or placebo ( n = 484 ) via subcutaneous injection for 76 weeks , in addition to statins . Main Outcomes and Measures The primary efficacy measure was the nominal change in percent atheroma volume ( PAV ) from baseline to week 78 , measured by serial intravascular ultrasonography ( IVUS ) imaging . Secondary efficacy measures were nominal change in normalized total atheroma volume ( TAV ) and percentage of patients demonstrating plaque regression . Safety and tolerability were also evaluated . Results Among the 968 treated patients ( mean age , 59.8 years [ SD , 9.2 ] ; 269 [ 27.8 % ] women ; mean LDL-C level , 92.5 mg/dL [ SD , 27.2 ] ) , 846 had evaluable imaging at follow-up . Compared with placebo , the evolocumab group achieved lower mean , time-weighted LDL-C levels ( 93.0 vs 36.6 mg/dL ; difference , -56.5 mg/dL [ 95 % CI , -59.7 to -53.4 ] ; P PAV , increased 0.05 % with placebo and decreased 0.95 % with evolocumab ( difference , -1.0 % [ 95 % CI , -1.8 % to -0.64 % ] ; P evolocumab ( difference , -4.9 mm3 [ 95 % CI , -7.3 to -2.5 ] ; P . Evolocumab induced plaque regression in a greater percentage of patients than placebo ( 64.3 % vs 47.3 % ; difference , 17.0 % [ 95 % CI , 10.4 % to 23.6 % ] ; P patients with angiographic coronary disease treated with statins , addition of evolocumab , compared with placebo , result ed in a greater decrease in PAV after 76 weeks of treatment . Further studies are needed to assess the effects of PCSK9 inhibition on clinical outcomes . Trial Registration clinical trials.gov Identifier : NCT01813422",
"BACKGROUND Serum proprotein convertase subtilisin/kexin 9 ( PCSK9 ) binds to low-density lipoprotein ( LDL ) receptors , increasing the degradation of LDL receptors and reducing the rate at which LDL cholesterol is removed from the circulation . REGN727/SAR236553 ( design ated here as SAR236553 ) , a fully human PCSK9 monoclonal antibody , increases the recycling of LDL receptors and reduces LDL cholesterol levels . METHODS We performed a phase 2 , multicenter , double-blind , placebo-controlled trial involving 92 patients who had LDL cholesterol levels of 100 mg per deciliter ( 2.6 mmol per liter ) or higher after treatment with 10 mg of atorvastatin for at least 7 weeks . Patients were r and omly assigned to receive 8 weeks of treatment with 80 mg of atorvastatin daily plus SAR236553 once every 2 weeks , 10 mg of atorvastatin daily plus SAR236553 once every 2 weeks , or 80 mg of atorvastatin daily plus placebo once every 2 weeks and were followed for an additional 8 weeks after treatment . RESULTS The least-squares mean ( ±SE ) percent reduction from baseline in LDL cholesterol was 73.2±3.5 with 80 mg of atorvastatin plus SAR236553 , as compared with 17.3±3.5 with 80 mg of atorvastatin plus placebo ( P mg of atorvastatin plus SAR236553 . All the patients who received SAR236553 , as compared with 52 % of those who received 80 mg of atorvastatin plus placebo , attained an LDL cholesterol level of less than 100 mg per deciliter , and at least 90 % of the patients who received SAR236553 , as compared with 17 % who received 80 mg of atorvastatin plus placebo , attained LDL cholesterol levels of less than 70 mg per deciliter ( 1.8 mmol per liter ) . CONCLUSIONS In a r and omized trial involving patients with primary hypercholesterolemia , adding SAR236553 to either 10 mg of atorvastatin or 80 mg of atorvastatin result ed in a significantly greater reduction in LDL cholesterol than that attained with 80 mg of atorvastatin alone . ( Funded by Sanofi and Regeneron Pharmaceuticals ; Clinical Trials.gov number , NCT01288469 . )",
"BACKGROUND Following acute coronary syndrome ( ACS ) , the risk for future cardiovascular events is high and is related to levels of low-density lipoprotein cholesterol ( LDL-C ) even within the setting of intensive statin treatment . Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) regulates LDL receptor expression and circulating levels of LDL-C. Antibodies to PCSK9 can produce substantial and sustained reductions of LDL-C. The ODYSSEY Outcomes trial tests the hypothesis that treatment with alirocumab , a fully human monoclonal antibody to PCSK9 , improves cardiovascular outcomes after ACS . DESIGN This Phase 3 study will r and omize approximately 18,000 patients to receive biweekly injections of alirocumab ( 75 - 150 mg ) or matching placebo beginning 1 to 12 months after an index hospitalization for acute myocardial infa rct ion or unstable angina . Qualifying patients are treated with atorvastatin 40 or 80 mg daily , rosuvastatin 20 or 40 mg daily , or the maximum tolerated and approved dose of one of these agents and fulfill one of the following criteria : LDL-C ≥ 70 mg/dL , non-high-density lipoprotein cholesterol ≥ 100 mg/dL , or apolipoprotein B ≥ 80 mg/dL. The primary efficacy measure is time to first occurrence of coronary heart disease death , acute myocardial infa rct ion , hospitalization for unstable angina , or ischemic stroke . The trial is expected to continue until 1613 primary end point events have occurred with minimum follow-up of at least 2 years , providing 90 % power to detect a 15 % hazard reduction . Adverse events of special interest include allergic events and injection site reactions . Interim analyses are planned when approximately 50 % and 75 % of the targeted number of primary end points have occurred . SUMMARY ODYSSEY Outcomes will determine whether the addition of the PCSK9 antibody alirocumab to intensive statin therapy reduces cardiovascular morbidity and mortality after ACS",
"OBJECTIVES This study sought to evaluate the efficacy and safety of subcutaneous evolocumab compared with oral ezetimibe in hypercholesterolemic patients who are unable to tolerate effective statin doses . BACKGROUND Statin intolerance , which is predominantly due to muscle-related side effects , is reported in up to 10 % to 20 % of patients . Evolocumab , a fully human monoclonal antibody to proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) , demonstrated marked reductions in plasma low-density lipoprotein cholesterol ( LDL-C ) in a phase 2 study in statin-intolerant patients . METHODS The GAUSS-2 ( Goal Achievement after Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects ) trial was a 12-week , double-blind study of r and omized patients ( 2:2:1:1 ) to evolocumab 140 mg every two weeks ( Q2W ) or evolocumab 420 mg once monthly ( QM ) both with daily oral placebo or subcutaneous placebo Q2W or QM both with daily oral ezetimibe 10 mg . Co- primary endpoints were percent change from baseline in LDL-C at the mean of weeks 10 and 12 , and at week 12 . RESULTS Three hundred seven patients ( age 62 ± 10 years ; LDL-C 193 ± 59 mg/dl ) were r and omized . Evolocumab reduced LDL-C from baseline by 53 % to 56 % , corresponding to treatment differences versus ezetimibe of 37 % to 39 % ( p occurred in 12 % of evolocumab-treated patients and 23 % of ezetimibe-treated patients . Treatment-emergent adverse events and laboratory abnormalities were comparable across treatment groups . CONCLUSIONS Robust efficacy combined with favorable tolerability makes evolocumab a promising therapy for addressing the largely unmet clinical need in high-risk patients with elevated cholesterol who are statin intolerant . ( Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2 ; NCT01763905 )",
"Background — Despite statin treatment , many patients with heterozygous familial hypercholesterolemia do not reach desired low-density lipoprotein cholesterol ( LDL-C ) targets . AMG 145 , a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) serine protease , demonstrated significant reductions in LDL-C in phase 1 studies . This phase 2 , multicenter , double-blind , r and omized , placebo-controlled , dose-ranging study evaluated the efficacy and safety of AMG 145 in heterozygous familial hypercholesterolemia patients . Methods and Results — Patients with heterozygous familial hypercholesterolemia diagnosed by Simon Broome criteria with LDL-C ≥2.6 mmol/L ( 100 mg/dL ) despite statin therapy with or without ezetimibe were r and omized 1:1:1 to AMG 145 350 mg , AMG 145 420 mg , or placebo-administered subcutaneously every 4 weeks . The primary end point was percentage change from baseline in LDL-C at week 12 . Of 168 patients r and omized , 167 received investigational product and were included in the full analysis set ( mean [ SD ] age , 50 [ 13 ] years ; 47 % female ; 89 % white ; mean [ SD ] baseline LDL-C , 4.0 [ 1.1 ] mmol/L ( 156 [ 42 ] mg/dL ) ) . At week 12 , LDL-C reduction measured by preparative ultracentrifugation ( least squares mean [ st and ard error ( SE ) ] ) was 43 (3)% and 55 (3)% with AMG 145 350 mg and 420 mg , respectively , compared with 1 (3)% increase with placebo ( P ) . Serious adverse events ( not considered treatment-related ) occurred in 2 patients on AMG 145 . Conclusions — AMG 145 administered every 4 weeks yielded rapid and substantial reductions in LDL-C in heterozygous familial hypercholesterolemia patients despite intensive statin use , with or without ezetimibe , with minimal adverse events and good tolerability . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT01375751",
"BACKGROUND LDL cholesterol ( LDL-C ) is a well established risk factor for cardiovascular disease . Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) binds LDL receptors , targeting them for degradation . We therefore assessed the efficacy , safety , and tolerability of AMG 145 , a human monoclonal IgG2 antibody against PCSK9 , in stable patients with hypercholesterolemia on a statin . METHODS In a phase 2 , dose-ranging study done in 78 centres in the USA , Canada , Denmark , Hungary , and Czech Republic , patients ( aged 18 - 80 years ) with LDL-C greater than 2·2 mmol/L on a stable dose of statin ( with or without ezetimibe ) , were r and omly assigned equally , through an interactive voice response system , to subcutaneous injections of AMG 145 70 mg , 105 mg , or 140 mg , or matching placebo every 2 weeks ; or subcutaneous injections of AMG 145 280 mg , 350 mg , or 420 mg , or matching placebo every 4 weeks . Everyone was masked to treatment assignment within the every 2 weeks and every 4 weeks schedules . The primary endpoint was the percentage change in LDL-C concentration from baseline after 12 weeks . Analysis was by modified intention to treat . This study is registered with Clinical Trials.gov , number NCT01380730 . FINDINGS 631 patients with hypercholesterolaemia were r and omly assigned to AMG 145 70 mg ( n=79 ) , 105 mg ( n=79 ) , or 140 mg ( n=78 ) , or matching placebo ( n=78 ) every 2 weeks ; or AMG 145 280 mg ( n=79 ) , 350 mg ( n=79 ) , and 420 mg ( n=80 ) , and matching placebo ( n=79 ) every 4 weeks . At the end of the dosing interval at week 12 , the mean LDL-C concentrations were reduced generally dose dependently by AMG 145 every 2 weeks ( ranging from 41·8 % to 66·1 % ; p and AMG 145 every 4 weeks ( ranging from 41·8 % to 50·3 % ; p occurred . The frequencies of treatment-related adverse events were similar in the AMG 145 and placebo groups ( 39 [ 8 % ] of 474 vs 11 [ 7 % ] of 155 ) ; none of these events were severe or life-threatening . INTERPRETATION The results suggest that PCSK9 inhibition could be a new model in lipid management . Inhibition of PCSK9 warrants assessment in phase 3 clinical trials . FUNDING Amgen"
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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 . Method : Sixty-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 = Published : 5 September 2008 International Journal of Behavioral Nutrition and Physical Activity 2008 , 5:44 doi:10.1186/1479 - 5868 - 5 - 44 Received : 18 January 2008 Accepted : 5 September 2008 This article is available from : http://www.ijbnpa.org/content/5/1/44 © 2008 Baker et al ; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0 ) , which permits unrestricted use , distribution , and reproduction in any medium , provided the original work is properly cited . International Journal of Behavioral Nutrition and Physical Activity 2008 , 5:44
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"Background Scotl and has a policy aim ed at increasing physical activity levels in the population , but evidence on how to achieve this is still developing . Studies that focus on encouraging real world participants to start physical activity in their setting s are needed . The Walking for Well-being in the West study was design ed to assess the effectiveness of a pedometer-based walking programme in combination with physical activity consultation . The study was multi-disciplinary and based in the community . Walking for Well-being in the West investigated whether Scottish men and women , who were not achieving the current physical activity recommendation , increased and maintained walking behaviour over a 12 month period . This paper outlines the rationale and design of this innovative and pragmatic study . Methods Participants were r and omised into two groups : Group 1 : Intervention ( pedometer-based walking programme combined with a series of physical activity consultations ) ; Group 2 : Waiting list control for 12 weeks ( followed by minimal pedometer-based intervention ) . Physical activity ( primary outcome ) was measured using pedometer step counts ( 7 day ) and the International Physical Activity Question naire ( long version ) . Psychological processes were measured using question naires relating to the Transtheoretical Model of Behaviour Change , mood ( Positive and Negative Affect Schedule ) and quality of life ( Euroqol EQ-5D instrument ) . Physiological measures included anthropometric and metabolic outcomes . Environmental influences were assessed subjectively ( Neighbourhood Quality of Life Survey ) and objective ly ( neighbourhood audit tool and GIS mapping ) . The qualitative evaluation employed observation , semi-structured interviews and focus groups . A supplementary study undertook an economic evaluation . Discussion Data analysis is on-going . Walking for Well-being in the West will demonstrate if a pedometer based walking programme , in combination with physical activity consultation results in a sustainable increase in walking behaviour in this sample of Scottish adults over a 12 month period . The study will examine the complex relationships between behavioural change , health consequences and the role of the environment , in conjunction with the cost effectiveness of this approach and a detailed insight into the participants ' experiences of the intervention . Trial registration Current Controlled Trials IS RCT",
"Aims /hypothesisThe aim of this study was to investigate the effectiveness of physical activity counselling in promoting physical activity in people with Type 2 diabetes and to evaluate result ant physiological and biochemical effects . Methods A total of 70 inactive people with Type 2 diabetes were given st and ard exercise information and r and omised to receive physical activity counselling ( n=35 , experimental ) or not ( n=35 , control ) . Physical activity consultations were delivered at baseline and after 6 months , with follow-up phone calls after 1 , 3 , 6 and 9 months . Changes from baseline after 6 and 12 months were assessed for physical activity ( 7-day recall and accelerometer ) , for physiological characteristics ( body mass index and blood pressure ) and for biochemical variables ( HbA1c , lipid profile , fibrinogen , tissue plasminogen activator and microalbuminuria ) . Results Significant differences between groups were recorded for physical activity after 6 and 12 months ( p levels of physical activity from baseline to 6 months ( p0.05 ) . In the control group , accelerometer counts per week decreased from baseline to 12 months ( p=0.03 ) . Between-group differences ( p HbA1c ( experimental : 0.26 % decrease ; control : 0.15 % increase ) , for systolic blood pressure ( experimental : 7.7 mm Hg decrease ; control : 5.6 mm Hg increase ) and for fibrinogen ( experimental : 0.28 mmol/l decrease ; control : 1.43 mmol/l increase ) from baseline to 6 months , and for total cholesterol ( experimental : 0.33 mmol/l decrease ; control : 0.04 mmol/l increase ) from baseline to 12 months ( p activity counselling was effective in promoting physical activity in people with Type 2 diabetes . The counselling improved glycaemic control as well as the status of cardiovascular risk factors in these patients",
"Background : Few studies have considered the neighborhood as a context in which to examine the physical activity and quality of life relationship . Purpose : The goal of this study was to evaluate the effects of a neighborhood walking program on quality of life among older adults . It was design ed as a r and omized trial involving a multilevel design with neighborhoods corresponding to primary sampling units and residents to secondary units . Methods : Five hundred eighty-two communitydwelling senior residents ( 65 years of age or older ) in neighborhoods in the northeast metropolitan area of Portl and , Oregon , were recruited through telephone , direct mail , and referrals . The walking intervention was delivered at the neighborhood level . Neighborhoods ( N = 56 ) were r and omly assigned to a 6-month , 3 times per week , leader-led walking group activity ( n = 28 ) or an information-only control group ( n = 28 ) . Primary outcome measures included SF-12 ( Physical , Mental summary scores ) and life satisfaction ( SWLS ) ; the secondary outcome measure was neighborhood walking activity , assessed at baseline , 3 months , and 6 months of the study period . Results : Compared to the control neighborhoods , results from multilevel , longitudinal analyses indicated significant improvements in the primary outcomes of SF-12 Physical ( p SF-12 Mental ( p ( p of walking activity ( p neighborhood-based walking program of low to moderate intensity is feasible and beneficial for promoting quality of life among senior residents at a community level",
"Introduction The health benefits of regular cardiovascular exercise are well-known . Such exercise , however , has traditionally been defined as vigorous physical activity , such as jogging , swimming , or aerobic dance . Exercise of moderate intensity also promotes health , and many U.S. adults may be experiencing the health benefits of exercise through lifestyle activities of moderate intensity , such as yard work , housework , or walking for transportation . Until recently , public health surveillance systems have not included assessment s of this type of physical activity , focusing on exercise of vigorous intensity . We used an enhanced surveillance tool to describe the prevalence and amount of both moderate-intensity and vigorous-intensity physical activity among U.S. adults . Methods We analyzed data from the 2001 Behavioral Risk Factor Surveillance System , a state-based , r and om-digit – dialed telephone survey administered to U.S. adults aged 18 years and older ( n = 82,834 men and 120,286 women ) . Physical activity behavior was assessed using questions design ed to quantify the frequency of participation in moderate- or vigorous-intensity physical activities performed during leisure time or for household chores and transportation . Results Overall , 45 % of adults ( 48 % of men and 43 % of women ) were active at recommended levels during nonworking hours ( at least 30 minutes five or more days per week in moderate-intensity activities , equivalent to brisk walking , or at least 20 minutes three or more days per week in vigorous activities , equivalent to running , heavy yard work , or aerobic dance ) . Less than 16 % of adults ( 15 % of men and 17 % of women ) reported no moderate or vigorous activity in a usual week . Conclusion Integrating surveillance of lifestyle activities into national systems is possible , and doing so may provide a more accurate representation of the prevalence of recommended levels of physical activity . These results , however , suggest that the majority of U.S. adults are not active at levels associated with the promotion and maintenance of health",
"PURPOSE The aim of this study was to quantify pedometer-determined steps per day associated with 50 , 100 , and 150 % of the current public health recommendation for weekly physical activity in sedentary postmenopausal women . METHODS A sample of 111 women from the DREW ( Dose Response to Exercise in Women ) study provided data . We r and omly assigned women into one of three exercise groups expending 4 , 8 , or 12 kcal(-1).kg(-1).wk(-1 ) ( KKW ) . Participants exercised alternately on a treadmill and recumbent cycle ergometer for a 6-month training period . Only treadmill sessions done with zero grade , at slow to moderate speeds ( 48 - 97 m.min(-1 ) ) were used in this analysis . We controlled intensity at a HR equivalent to 50 % of VO(2peak ) . Participants wore pedometers at baseline and throughout the study to assess their free-living physical activity ( steps.d(-1 ) ) RESULTS Baseline averages were exercise training , free-living step counts remained Average speeds and distances per exercise session were 2.7 + /- 0.4 mph , 1.2 + /- 0.2 miles ( 4 KKW ) , 2.6 + /- 0.4 mph , 2.2 + /- 0.4 miles ( 8 KKW ) , and 2.8 + /- 0.3 mph , 2.7 + /- 0.4 miles ( 12 KKW ) . This yielded 2771 ( 4 KKW ) , 5457 ( 8 KKW ) , and 6534 ( 12 KKW ) steps per exercise session 3 - 4 d.wk(-1 ) . CONCLUSIONS Initially sedentary postmenopausal women can meet 50 % ( 4 KKW ) , 100 % ( 8 KKW ) , and 150 % ( 12 KKW ) of the current public health recommendation of weekly physical activity through planned moderate-intensity walking , accumulating an average of about 2800 ( 50 % ) , 5500 ( 100 % ) , and 6500 steps.d(-1 ) ( 150 % ) 3 - 4 d.wk(-1 )",
"OBJECTIVE : To conduct a r and omised trial of a physical activity ( PA ) intervention , The First Step Program ( FSP ) for adults with type II diabetes . DESIGN : A 16-week intervention study and 24-week follow-up assessment . PARTICIPANTS : A total of 47 overweight/obese , sedentary individuals ( age=52.7±5.2 y ; BMI = 33.3±5.6 kg/m2 ) recruited through a diabetes education centre . MEASUREMENTS : Primary outcome : daily PA assessed by pedometer ( steps/day ) . Secondary outcomes : anthropometric measures ( weight , BMI , waist girth , hip girth ) ; indicators of cardiovascular health ( resting heart rate and blood pressure ) ; glycemic control ( fasting glucose , insulin , HbA1c , glucose concentration 120 min postglucose load ) ; plasma lipid status ( total cholesterol , HDL cholesterol , LDL cholesterol , and triglycerides ) . RESULTS : Relative to the CONTROL group , FSP participants increased their PA > 3000 steps/day ( approximately 30 min/day ) during the intervention ( P decreased ( approximately 2–3 cm ) , but did not differ significantly between groups . Significant changes did not emerge for any of the other variables . CONCLUSIONS : The FSP is a practical intervention that elicits an immediate and profound change in walking behaviour . Such change is an important ‘ first step ’ towards increasing the volume and /or intensity of PA necessary to improve long-term health outcomes in this largely sedentary and overweight or obese population . Relapse by 24 weeks indicates that other strategies such as booster sessions are needed to maintain lifestyle change . Further research must determine realistic and responsive health outcomes for this population that are achievable through practical , real-world programming",
"OBJECTIVE to examine the effects and feasibility of educating and empowering older people with ischaemic heart disease using trained senior lay health mentors . DESIGN r and omised controlled trial with blinded evaluation . SETTING Falkirk and District Royal Infirmary . PARTICIPANTS in patients and out patients aged 60 or over attending secondary care with a diagnosis of angina or acute myocardial infa rct ion . Three-hundred and nineteen entered and 289 completed exit assessment s. The intervention group took part in mentoring groups for 1 year , meeting monthly for 2 hours , each led by two trained lay health mentors in addition to st and ard care . MAIN OUTCOME MEASURES primary outcome measures were changes in coronary risk factors , medication usage and actual use of secondary care health services . Secondary outcomes were total and cardiovascular events ; changes in medication compliance , non-medical support requirement , health status and psychological functioning , and social inclusion . RESULTS there were significant improvements in a reported current exercise score ( mean + 0.33 , + 0.02 to + 0.52 ) , in the average time spent walking per week by 72 minutes ( + 1 to + 137 minutes ) , and in the SF36 Physical Functioning Score ( + 6.1 , + 2.4 to + 9.5 ) . There was a 1.0 % reduction in total fat ( 95 % CI -3.0 % to -0.6 % ) and a 0.6 % reduction in saturated fat ( 95 % CI -1.5 % to -0.03 % ) . The intervention group showed reduced outpatient attendance for coronary heart disease ( -0.25 appointments , -0.61 to -0.08 ) . Attendance rates were high . Socio-economic grouping did not affect participation . CONCLUSIONS Lay Health Mentoring is feasible , practical and inclusive , positively influencing diet , physical activity , and health re source utilisation in older subjects with ischaemic heart disease without causing harm",
"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",
"OBJECTIVE To evaluate effect of exercise consultation on physical activity and result ant physiological and biochemical variables at 6 months in people with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 70 inactive people with type 2 diabetes were given st and ard exercise information and were r and omized to receive an exercise consultation ( n = 35 ) or not ( n = 35 ) . Exercise consultation , based on the transtheoretical model , combines motivational theory and cognitive behavioral strategies into an individualized intervention to promote physical activity . Changes from baseline to 6 months were assessed in 1 ) physical activity ( 7-day recall , accelerometer , cardiorespiratory fitness , stage , and processes of change ) , 2 ) physiological variables ( blood pressure and BMI ) , and 3 ) biochemical variables ( HbA(1c ) , lipid profile , and fibrinogen ) . RESULTS Between-group differences were recorded for the change in minutes of moderate activity ( P activity counts ( P activity counts per week and minutes of moderate activity per week ( P total exercise duration and peak gradient ( P HbA(1c ) ( P = 0.02 ) , systolic BP ( P = 0.02 ) , and fibrinogen ( P = 0.03 ) . CONCLUSIONS Exercise consultation increased physical activity and improved glycemic control and cardiovascular risk factors in people with type 2 diabetes",
"OBJECTIVE 1 . To demonstrate that combining pedometer use with cognitive and behavioral support material s has a positive effect on physical activity ( PA ) and attitudes towards pedometer use . 2 . To investigate how familiar the study sample is with pedometers and the ' 10,000 steps/day ' recommendation . METHODS From a r and om sample , drawn from the phone book , 304 volunteered ( 18 - 75 year ) to complete a question naire about familiarity with pedometers and the ' 10,000 steps/day ' recommendation . A sample of 103 participants agreed to wear a pedometer for 3 weeks , and was r and omly assigned to a condition with cognitive and behavioral support material s ( n=51 ) or without these material s ( n=52 ) . Participants completed the International Physical Activity Question naire before and after 21 days of pedometer use and an additional question naire on the attitudes towards pedometer use . RESULTS More than 58 % had never heard of a pedometer . In both conditions , walking ( F=10 , p=0.002 ) , moderate PA ( F=11 , p=0.001 ) , and vigorous PA ( F=14 , p interaction effects could be found . Significantly more participants in the condition with support material s had a positive attitude towards pedometer use . CONCLUSION Wearing a pedometer , with or without support material s , may increase PA . In our study , cognitive and behavioral support material s only affected attitudes towards pedometer use . PRACTICE IMPLICATION S More research is needed to investigate the effect of combining pedometer use with support material s on a longer time base and in less motivated people",
"This study reports an investigation of the effect of participating in moderate exercise ( three 40-min sessions of brisk walking a week for 6 months ) on mood state in 177 sedentary , mildly hypertensive volunteers . Mood was assessed by the Profile of Mood States , Bipolar Form ( POMS-BI ) , and no significant differences were found between control and exercise groups . The intervention group increased its exercise output more than the control group , but there was also a significant increase in exercise done by the control group . We conclude that exercise has no major effect on mood in hypertensive volunteers",
"BACKGROUND Pedometers have been identified as a potential motivational aid for increasing physical activity , but their efficacy has not been demonstrated in a community-based , non clinical sample . DESIGN A r and omized controlled trial was conducted from August to December 2005 . Analysis was completed in June 2006 . SETTING / PARTICIPANTS Inactive adults aged 30 - 65 years ( n=369 ) recruited from the community . INTERVENTION Comparison of a theoretically based self-help walking program ( WP ) and weekly diaries ( sent by mail ) ; the same walking program with a pedometer ( WPP ) ( also by mail ) ; and a no-treatment control group ( C ) . MEASURES Change in self-reported leisure time in any sports/recreation in the last 3 months , and all- purpose walking ( APW ) for exercise , recreation , and travel , and other moderate , vigorous physical activity in the last week . Proportions meeting physical activity recommendations ( equal to or greater than 150 minutes and equal to or greater than five sessions/week(-1 ) ) were determined . RESULTS A 3-month follow-up interview was conducted with 314 ( 85 % ) participants . Intention-to-treat analyses indicated significance within-group increases of APW and leisure-time walking ( LTW ) , but mean and median sessions and minutes changes were greatest in the WPP group . There were no significant between-group differences in regular LTW ( walked equal to or greater than 5 sessions/week(-1 ) for at least 30 minutes/session ) , but the WPP group increased significantly participation in other sports/recreations and was more likely than the control group to meet physical activity recommendations by all leisure-time physical activity ( adjusted odds ratio=2.40 , 95 % CI=1.17 - 4.93 ) , by APW ( adjusted odds ratio=1.75 95 % CI=0.92 - 3.34 ) and all physical activity ( adjusted odds ratio=1.59 95 % CI=0.92 - 2.79 ) in the last week . CONCLUSIONS Pedometers enhanced the effects of the self-help walking program . This low-cost intervention should be tested for sustainability",
"OBJECTIVES To determine whether a home-based pedometer-driven walking program with arthritis self-management education ( Walk + ) would increase physical activity , muscle strength , and functional performance in older adults with osteoarthritis ( OA ) of the knee as opposed to arthritis self-management education alone ( EDU ) . DESIGN A r and omized two-by-three ( group-by-time ) design with participants assigned to Walk + ( n = 17 , mean age + /- st and ard deviation = 69.6 + /- 6.7 ) or EDU ( n = 17 , age = 70.8 + /- 4.7 ) . SETTING Community located in the Baltimore-Washington area . PARTICIPANTS Thirty-four community-dwelling adults , aged 60 and older with symptomatic knee OA and self-reported functional impairment . INTERVENTIONS Both groups received 12 hours of the Arthritis Self-Management program over 12 weeks and were followed for an additional 12 weeks . In addition , the Walk + group received individualized instruction in the use of a pedometer , with the goal of increasing their step count by 30 % of their baseline step count . MEASUREMENTS The outcome measures were physical activity ( daily step counts and total activity vector magnitude as measured by a pedometer and Tritrac-R3D accelerometer ) , quadriceps femoris strength ( isometric peak torque ) , and functional performance tasks ( 100-foot walk-turn-walk , timed stair climb , timed chair rise , and pain status ) . RESULTS Daily steps walked showed a significant group-by-time interaction ( P = .04 ) after controlling for age . From baseline to completion of training , a 23 % increase in daily steps occurred in the Walk + group and a 15 % decrease in the EDU group . Although steps increased in the Walk + group , total activity vector magnitude was maintained , suggesting a more efficient gait . The Walk + group became quicker than the EDU group in the normal-pace walk-turn-walk ( P = .04 ) . An isometric strength gain of 21 % postintervention was seen in the Walk + group , compared with a loss of 3.5 % in the EDU group . CONCLUSION In older adults with symptomatic knee OA , Walk + appears to increase walking , with improvements in muscle strength and walking performance . The use of a home-based pedometer-driven program to increase physical activity , strength , and function in this population warrants further research",
"PURPOSE ( a ) To establish pedometer steps/min intensity categories ( i.e. , light , moderate , hard , very hard ) for adults under controlled conditions , and ( b ) use these cut-points to ascertain the number of steps expected in 30 minutes of moderate intensity activity . METHODS 25 men and 25 women , ages 18 - 39 years , performed 6-min exercise bouts at 3 treadmill speeds ( 4.8 , 6.4 , and 9.7 km/hr ) . Yamax SW-200 pedometers indicated steps , and steady-state VO2 was recorded . METs were calculated by dividing steady-state VO2 by 3.5 ml x kg(-1 ) x min(-1 ) . Linear regression was used to quantify the relationships between steps/min and METs across all speeds . Ten participants ( 5 M , 5 F ) were r and omly selected from the original 50 and constituted a holdout sample for cross-validation purpose s ( i.e , comparing actual and predicted METs ; paired t-test ) . RESULTS The regression equation for males was : METs = -7.065 + ( 0.105 x steps/min ) r2 = 0.803 . For females it was : METs = -8.805 + ( 0.110 x steps/min ) r2 = 0.830 . Cross-validation was confirmed . CONCLUSIONS Pedometer cut-points corresponding to minimal moderate intensity walking were 96 steps/min in men and 107 steps/min in women , or roughly 100 steps/min for both . This translates to approximately 3,000 steps in 30 min of moderate-intensity ambulatory activity for both genders",
"BACKGROUND Physical activity ( PA ) has been shown to benefit glucose tolerance . Walking is a convenient low-impact mode of PA and is reported to be the most commonly performed activity for those with diabetes . The purpose of this study was to determine whether a recommendation to accumulate 10,000 steps/day for 8 weeks was effective at improving glucose tolerance in overweight , inactive women . METHODS Eighteen women ( 53.3 + /- 7.0 years old , 35.0 + /- 5.1 kg/m(2 ) ) with a family history of type 2 diabetes completed a 4-week control period followed by an 8-week walking program with no changes in diet . The walking program provided a goal of accumulating at least 10,000 steps/day , monitored by a pedometer . RESULTS During the control period , participants walked 4972 steps/day . During the intervention period , the participants increased their accumulated steps/day by 85 % to 9213 , which result ed in beneficial changes in 2-h postload glucose levels ( P AUC(glucose ) ( P = 0.025 ) , systolic blood pressure ( P diastolic blood pressure ( P = 0.002 ) . There were no changes in body mass , body fat percentage , and waist circumference during the walking intervention . CONCLUSIONS The 10,000 steps/day recommendation result ed in improved glucose tolerance and a reduction in systolic and diastolic blood pressure in overweight women at risk for type 2 diabetes . This demonstrates that activity can be accumulated throughout the day and does not have to result in weight loss to benefit this population",
"Voluntary employees ( N = 155 ) from nine different companies were screened by question naire for the study . They were r and omized into three study groups : counseling ( n = 52 ) , counseling + fitness testing ( n = 51 ) and control group ( n = 52 ) . The counseling was based on a goal -oriented conversation session for each participant and three follow-up appointments with an occupational nurse over a period of 1 year . The fitness tests were adapted from the UKK Health-related Fitness Test Battery . The outcome measures were the changes in the amount of leisure-time physical activity ( LTPA ) assessed by diary , pedometer and question naire at baseline and at 6 and 12 month follow-up visits . As a result , no statistically significant differences were detected between the three groups at either of the follow-up visits . It seemed , thus , that the two PA counseling methods implemented had no direct mid- or long-term effects on the LTPA of voluntary employees with no specific disease-related indication to increase LTPA",
"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",
"Because of their frequent encounters with sedentary patients , family physicians are poised to be on the forefront of the medical community 's response to physical inactivity . The purpose of this pilot study was to examine whether the addition of a pedometer to brief physician counseling could help patients increase their ambulatory activity . Ninety four participants recruited from a family medicine clinic were r and omly assigned to 2 groups . Both groups received a brief physician endorsement of regular physical activity , a h and out on the benefits of an active lifestyle , and 3 follow-up phone calls from a health educator . In addition , the intervention group received a pedometer and was instructed to record their steps daily over the 9-week study period . Measurements were taken for self-reported walking , walking stage-of-change , walking self-efficacy , and pedometer steps ( intervention group only ) . Among completers , mean daily step counts in the pedometer group rose from 6779 at baseline to 8855 at study end . Average individual improvement was 41 % over the study period . Both groups significantly increased blocks walked per day , stair climbing versus using the elevator , days per week walking > or = 30 minutes , and walking for fun/leisure . The frequency of walking short trips improved significantly more in the pedometer group relative to the comparison group . The results of this pilot study highlight the need for further research on the use of pedometers as a motivational tool in the context of medical encounters with inactive patients ",
"Recent physical activity recommendations call for activities that are of moderate intensity and can be performed intermittently during the day , such as walking . These proclamations were based partly on the assumption that moderate activities are generally more enjoyable than physically dem and ing ones , and they are , therefore , also more likely to be continued over the long haul . However , little is actually known about the affective outcomes of short bouts of walking and extant findings are equivocal . Four experimental studies examined the affective responses associated with short ( 10- to 15-min ) bouts of walking using a dimensional conceptual model of affect , namely , the circumplex . Results consistently showed that walking was associated with shifts toward increased activation and more positive affective valence . Recovery from walking for 10–15 min was associated with a return toward calmness and relaxation . This pattern was robust across different self-report measures of the circumplex affective dimensions , across ecological setting s ( field and laboratory ) , across time , and across sample",
"PURPOSE Walking is the most common leisure-time physical activity ( LTPA ) among U.S. adults . The purpose of this study was to estimate the prevalence of walking for physical activity and the proportion of walkers who met current public health physical activity recommendations . METHODS We analyzed data from the 1998 Behavioral Risk Factor Surveillance System , a collection of state-based , r and om-digit-dialed telephone surveys of adults . Physical activity measures included the type , frequency , and duration of the two LTPAs in which respondents engaged most often during the previous month . We calculated the prevalence of walking and the prevalence of three physical activity patterns defined by combinations of walking duration and frequency . We also examined the effect on these patterns of participating in a second LTPA . RESULTS In 1998 , an estimated 38.6 % of U.S. adults walked for physical activity . Among walkers , 21.3 % walked a minimum of 30 min five or more times per week . This approximates compliance with current physical activity recommendations . Compliance increased to 34.5 % when the criteria were relaxed to include at least 150 min of walking per week accumulated over three or more occasions . Relaxing the criteria further to include a minimum of 150 min.wk(-1 ) regardless of frequency produced only a small increase in compliance ( 37.6 % ) . However , compliance with each of these three activity patterns approximately doubled when a second LTPA was taken into account . CONCLUSIONS Less than 40 % of walkers complied through walking with even our most liberal physical activity pattern ( > or = 150 min.wk(-1 ) regardless of frequency ) . For walkers to meet current public health recommendations , many need to walk more frequently and /or to engage in additional physical activities",
"OBJECTIVE To evaluate a telephone counseling intervention that was design ed to help sedentary women begin and maintain a walking program . METHODS Females ( N = 197 ) were r and omly assigned to either an intervention , attention control , or no-attention control group . Assessment s were made at baseline and 6 months . RESULTS Women in the intervention group reported more time walked each day than did control women ( P women as well as for different income groups . CONCLUSION Overall , a counseling intervention via telephone appears to be a good way to help women begin a walking program",
"The main aim of this study was to assess the effects of a fitness assessment and exercise consultation on physical activity over 1 year in non-regularly active participants drawn from a socially and economically deprived community . Of 3000 people invited to volunteer for either intervention , 225 fitness assessment volunteers were r and omly assigned to an experimental or control group ; 145 exercise consultation volunteers were similarly assigned . Physical activity was measured at baseline , 4 weeks , 3 months ( plus an intervention re-test ) , 6 months and 1 year . Analysis of variance and follow-up Bonferroni analysis showed that , for those not regularly active at baseline , physical activity increased significantly to 4 weeks , was maintained to 6 months but had fallen by 1 year . Only those receiving an exercise consultation significantly increased their physical activity after 1 year . Compared with fitness assessment s , chi-square analysis showed that significantly more non-regularly active participants volunteered for an exercise consultation and those receiving an exercise consultation had significantly better long-term study adherence than those receiving a fitness assessment . The study also showed that , contrary to popular opinion , those in a socially and economically deprived community are not ' hard to reach ' and respond well to physical activity interventions",
"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",
"OBJECTIVE To investigate the link between a reduction in blood pressure ( BP ) and daily exercise . DESIGN Cross-sectional and longitudinal clinical intervention study with exercise education . SUBJECTS 43 overweight Japanese men aged 32 - 59 years ( BMI , 29.0+/-2.3 kg/m2 ) at baseline . Among the participants , a r and omly selected 23 overweight men ( BMI , 28.5+/-1.7 ) were further enrolled into the 10 months exercise program . MEASUREMENTS BP was measured every week and steps per day were also recorded every day throughout the observation period . Fat distribution was evaluated by visceral fat ( V ) and subcutaneous fat ( S ) areas measured with computed tomography ( CT ) scanning at umbilical level , at before , 5 months and after intervention . Anthropometric parameters were also measured at same point . Aerobic exercise level , muscle strength , flexibility and calorie intake and insulin resistance ( HOMA index ) were investigated at before and after the study . RESULTS In a cross sectional analysis , systolic BP ( SBP ) and diastolic BP ( DBP ) were significantly correlated with body composition . In a second longitudinal analysis , SBP was significantly reduced at 2 months and DBP was also reduced at 3 months , and almost maintained until the end of the observation period . Increasing daily walking was observed in 3 months and maintained until 10 months . Body composition , aerobic exercise level , muscle strength , flexibility and insulin resistance were significantly improved . There was positive correlation between DeltaDBP and Deltavisceral fat area ( 1 - 5 , 5 - 10 , 1 - 10 months ) . By stepwise multiple regression analysis , only Deltavisceral fat area was independently related to DeltaDBP at a significant level ( 1 - 10 months : DeltaDBP=-0.608 + 0.105Deltavisceral fat area , r2=0.227 , P=0.0334 ) . CONCLUSION The present study indicated daily exercise lowers BP and visceral fat area is the critical factor for BP change",
"BACKGROUND Although exercise parameters such as intensity and format have been shown to influence exercise participation rates and physiological outcomes in the short term , few data are available evaluating their longer-term effects . The study objective was to determine the 2-year effects of differing intensities and formats of endurance exercise on exercise participation rates , fitness , and plasma HDL cholesterol levels among healthy older adults . METHODS AND RESULTS Higher-intensity , group-based exercise training ; higher-intensity , home-based exercise ; and lower-intensity , home-based exercise were compared in a 2-year r and omized trial . Participants were 149 men and 120 postmenopausal women 50 to 65 years of age who were sedentary and free of cardiovascular disease . Recruitment was achieved through a r and om digit-dial community telephone survey and media promotion . All exercise occurred in community setting s. For higher-intensity exercise training , three 40-minute endurance training sessions per week were prescribed at 73 % to 88 % of peak treadmill heart rate . For lower-intensity exercise , five 30-minute endurance training sessions per week were prescribed at 60 % to 73 % of peak treadmill heart rate . Treadmill exercise performance , lipoprotein levels and other heart disease risk factors , and exercise adherence were evaluated at baseline and across the 2-year period . Treadmill exercise test performance improved for all three training conditions during year 1 and was successfully maintained during year 2 , particularly for subjects in the higher-intensity , home-based condition . Subjects in that condition also showed the greatest year 2 exercise adherence rates ( P HDL cholesterol were observed during year 1 , by the end of year 2 subjects in the two home-based training conditions showed small but significant HDL cholesterol increases over baseline ( P HDL cholesterol were associated with decreases in waist-to-hip ratio in both men and women ( P HDL cholesterol levels , the time frame needed to achieve HDL cholesterol change ( 2 years ) may be longer than that reported previously for younger population s. Frequency of participation may be particularly important for achieving such changes . Supervised home-based exercise regimens represent a safe , attractive alternative for achieving sustained participation",
"BACKGROUND Inactivity is a leading contributor to chronic health problems . Here , we examined the effects of a pedometer-based physical activity intervention ( Prince Edward Isl and -First Step Program , PEI-FSP ) on activity and specific health indices in 106 sedentary workers . METHODS Participants were recruited from five workplaces where most jobs were moderately-highly sedentary . Using subjects as their own control , physical activity ( pedometer-determined steps per day ) was compared before and after a 12-week intervention . Changes in body mass index ( BMI ) , waist girth , resting heart rate , and blood pressure were evaluated . RESULTS The PEI-FSP was completed by 59 % of participants . Steps per day increased from 7,029 + /- 3,100 ( SD ) at baseline to a plateau of 10,480 + /- 3,224 steps/day by 3.96 + /- 3.28 weeks of the intervention . The amount that participants were able to increase their steps per day was not related to their baseline BMI . On average , participants experienced significant decreases in BMI , waist girth , and resting heart rate . Reductions in waist girth and heart rate were significantly related to the increase in steps per day . In contrast , reductions in BMI were predicted by the initial steps per day . CONCLUSIONS The PEI-FSP increased physical activity in a sedentary population . Importantly , those with a higher BMI at baseline achieved relatively similar increases in their physical activity as participants with a lower BMI"
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BACKGROUND Although serum 25-hydroxyvitamin D [ 25(OH)D ] is the currently accepted vitamin D status marker of choice , use of other biomarkers or functional endpoints have been suggested . OBJECTIVE The objective was to systematic ally review the effectiveness of 25(OH)D , parathyroid hormone ( PTH ) , bone turnover markers , bone mineral density ( BMD ) , and calcium absorption as biomarkers of vitamin D status . DESIGN Methods included a structured search on Ovid MEDLINE , EMBASE ( Ovid ) , and Cochrane CENTRAL ; rigorous inclusion /exclusion criteria ; data extraction ; quality assessment ; meta- analysis ; and meta-regression . RESULTS Thirty-six vitamin D supplementation r and omized controlled trials ( RCTs ) and 4 before-after studies were included . Vitamin D supplementation significantly raised circulating 25(OH)D in all but one RCT , but the response was highly heterogeneous [ weighted mean difference ( WMD ) : 34.1 nmol/L ; 95 % CI : 28.9 , 39.2 ; 32 RCTs ; I2 = 97 % ) . Vitamin D supplementation ( without calcium ) significantly lowered circulating PTH ( WMD : -0.29 pmol/L ; 95 % CI : -0.56 , -0.02 ; 11 RCTs ; I2 = 29 % ) , but this was not apparent in the presence of calcium supplementation . There was a suggestion that whole-body or lumbar spine BMD may be a useful biomarker in older people but not in adolescents . Bone turnover markers were not useful biomarkers of vitamin D status , but 4 before-after studies suggested that intestinal calcium absorption may respond to vitamin D status . CONCLUSIONS This systematic review confirmed that circulating 25(OH)D is a robust and reliable marker of vitamin D status . Further research is needed to clarify which population subgroups show responses of PTH , BMD , and /or calcium absorption in response to changes in vitamin D status
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"Objective : To assess the vitamin D status of healthy young people living in Northern Irel and and the effect of vitamin D supplementation on vitamin D status and bone turnover . Design : Double-blinded r and omised controlled intervention study . Setting : University of Ulster , Coleraine , Northern Irel and .Subjects : In total , 30 apparently healthy students ( 15 male and 15 female subjects ) , aged 18–27 years , were recruited from the university , with 27 completing the intervention . Interventions : Subjects were r and omly assigned , to receive either 15 μg ( 600 IU ) vitamin D3 and 1500 mg calcium/day ( vitamin D group ) , or 1500 mg calcium/day ( control group ) for 8 weeks between January and March . Vitamin D status , bone turnover markers , serum calcium and parathyroid hormone concentrations were measured at baseline and post intervention . Results : At baseline , vitamin D status was low in both the vitamin D group ( 47.9 ( s.d . 16.0 ) ) and the control group ( 55.5 ( s.d . 18.6 ) nmol/l 25(OH)D ) . Post intervention vitamin D status was significantly higher in the vitamin D-treated group ( 86.5 ( s.d . 24.5 ) ) compared to the control group ( 48.3 ( s.d . 16.8 ) nmol/l ) ( P supplementation on bone turnover markers or PTH concentrations . Conclusions : This study suggests that young adults in Northern Irel and do not consume an adequate daily dietary intake of vitamin D to maintain plasma vitamin D concentrations in the wintertime . A daily supplement of 15 μg vitamin D3 significantly increased vitamin D status in these individuals to levels of sufficiency . Achievement of an optimum vitamin D status among young adults may have future positive health implication",
"The necessity and safety of an oral calcium ( Ca ) and vitamin D regimen was evaluated in a population of 66 independently living and 73 institutionalized elderly women over an 11-week winter period . The members of both groups were r and omly assigned into trial and control groups . Serum Ca , creatinine , and calcidiol levels were measured before and after the trial . The regimen consisted of 1.558 g of Ca and 45 micrograms ( equal to 1,800 IU ) of vitamin D administered daily in addition to the normal diet . The controls received no treatment . A majority of the elderly subjects living independently had ensured their Ca , and a quarter of them also their vitamin D intake on their own initiative . The mean serum calcidiol concentration before the trial was 24.1 nmol/L in the institutionalized and 38.5 nmol/L in the elderly subjects living independently ( P less than .001 ) . After the trial , serum calcidiol was 10.4 nmol/L in the institutionalized control subjects and had decreased ( P less than .001 ) in both control groups , but increased ( P less than .001 ) in both treatment groups . The safety indicators , serum Ca , creatinine , and calcidiol , did not indicate any group or individual side effect",
"Background : Calcium absorption is generally considered to be impaired under conditions of vitamin D deficiency , but the vitamin D status that fully normalizes absorption is not known for humans . Objective : To quantify calcium absorption at two levels of vitamin D repletion , using pharmacokinetic methods and commercially marketed calcium supplements . Design : Two experiments performed in the spring of the year , one year apart . In the first , in which participants were pretreated with 25-hydroxyvitamin D ( 25OHD ) , mean serum 25OHD concentration was 86.5 nmol/L ; and in the other , with no pretreatment , mean serum concentration was 50.2 nmol/L. Participants received 500 mg oral calcium loads as a part of a st and ard low calcium breakfast . A low calcium lunch was provided at mid-day . Blood was obtained fasting and at frequent intervals for 10 to 12 hours thereafter . Methods : Relative calcium absorption at the two 25OHD concentrations was estimated from the area under the curve ( AUC ) for the load-induced increment in serum total calcium . Results : AUC9 ( ± SEM ) , was 3.63 mg hr/dL ± 0.234 in participants pretreated with 25OHD and 2.20 ± 0.240 in those not pretreated ( P brief , absorption was 65 % higher at serum 25OHD levels averaging 86.5 nmol/L than at levels averaging 50 nmol/L ( both values within the nominal reference range for this analyte ) . Conclusions : Despite the fact that the mean serum 25OHD level in the experiment without supplementation was within the current reference ranges , calcium absorptive performance at 50 nmol/L was significantly reduced relative to that at a mean 25OHD level of 86 nmol/L. Thus , individuals with serum 25-hydroxyvitamin D levels at the low end of the current reference ranges may not be getting the full benefit from their calcium intake . We conclude that the lower end of the current reference range is set too low",
"BACKGROUND Numerous observational studies have found supplemental calcium and vitamin D to be associated with reduced risk of common cancers . However , interventional studies to test this effect are lacking . OBJECTIVE The purpose of this analysis was to determine the efficacy of calcium alone and calcium plus vitamin D in reducing incident cancer risk of all types . DESIGN This was a 4-y , population -based , double-blind , r and omized placebo-controlled trial . The primary outcome was fracture incidence , and the principal secondary outcome was cancer incidence . The subjects were 1179 community-dwelling women r and omly selected from the population of healthy postmenopausal women aged > 55 y in a 9-county rural area of Nebraska centered at latitude 41.4 degrees N. Subjects were r and omly assigned to receive 1400 - 1500 mg supplemental calcium/d alone ( Ca-only ) , supplemental calcium plus 1100 IU vitamin D3/d ( Ca + D ) , or placebo . RESULTS When analyzed by intention to treat , cancer incidence was lower in the Ca + D women than in the placebo control subjects ( P unadjusted relative risks ( RR ) of incident cancer in the Ca + D and Ca-only groups were 0.402 ( P = 0.01 ) and 0.532 ( P = 0.06 ) , respectively . When analysis was confined to cancers diagnosed after the first 12 mo , RR for the Ca + D group fell to 0.232 ( CI : 0.09 , 0.60 ; P treatment and serum 25-hydroxyvitamin D concentrations were significant , independent predictors of cancer risk . CONCLUSIONS Improving calcium and vitamin D nutritional status substantially reduces all-cancer risk in postmenopausal women . This trial was registered at clinical trials.gov as NCT00352170",
"Abstract : Supplementation of elderly institutionalized women with vitamin D and calcium decreased hip fractures and increased hip bone mineral density . Quantitative ultrasound ( QUS ) measurements can be performed in nursing homes , and easily repeated for follow-up . However , the effect of the correction of vitamin D deficiency on QUS parameters is not known . Therefore , 248 institutionalized women aged 62–98 years were included in a 2-year open controlled study . They were r and omized into a treated group ( n = 124 ) , receiving 440 IU of vitamin D3 combined with 500 mg calcium ( 1250 mg calcium carbonate , Novartis ) twice daily , and a control group ( n = 124 ) . One hundred and three women ( 42 % ) , aged 84.5 ± 7.5 years , completed the study : 50 in the treated group , 53 in the controls . QUS of the calcaneus , which measures BUA ( broadb and ultrasound attenuation ) and SOS ( speed of sound ) , and biochemical analysis were performed before and after 1 and 2 years of treatment . Only the results of the women with a complete follow-up were taken into account . Both groups had low initial mean serum 25-hydroxyvitamin D levels ( 11.9 ± 1.2 and 11.7 ± 1.2 mg/l ; normal range 6.4–40.2 mg/l ) and normal mean serum parathyroid hormone ( PTH ) levels ( 43.1 ± 3.2 and 44.6 ± 3.5 ng/l ; normal range 10–70 ng/l , normal mean 31.8 ± 2.3 ng/l ) . The treatment led to a correction of the metabolic disturbances , with an increase in 25-hydroxyvitamin D by 123 % ( p50.01 ) and a decrease in PTH by 18 % ( p50.05 ) and of alkaline phosphatase by 15 % ( p50.01 ) . In the controls there was a worsening of the hypovitaminosis D , with a decrease of 25-hydroxyvitamin D by 51 % ( p50.01 ) and an increase in PTH by 51 % ( p50.01 ) , while the serum calcium level decreased by only 2 % ( p5 0.01 ) . After 2 years of treatment BUA increased significantly by 1.6 % in the treated group ( p50.05 ) , and decreased by 2.3 % in the controls ( p50.01 ) . Therefore , the difference in BUA between the treated subjects and the controls ( 3.9 % ) was significant after 2 years ( p50.01 ) . However , SOS decreased by the same amount in both groups ( approximately 0.5 % ) . In conclusion , BUA , but not SOS , reflected the positive effect on bone of supplementation with calcium and vitamin D3 in a population of elderly institutionalized women",
"BACKGROUND The cholecalciferol inputs required to achieve or maintain any given serum 25-hydroxycholecalciferol concentration are not known , particularly within ranges comparable to the probable physiologic supply of the vitamin . OBJECTIVES The objectives were to establish the quantitative relation between steady state cholecalciferol input and the result ing serum 25-hydroxycholecalciferol concentration and to estimate the proportion of the daily requirement during winter that is met by cholecalciferol reserves in body tissue stores . DESIGN Cholecalciferol was administered daily in controlled oral doses labeled at 0 , 25 , 125 , and 250 micro g cholecalciferol for approximately 20 wk during the winter to 67 men living in Omaha ( 41.2 degrees N latitude ) . The time course of serum 25-hydroxycholecalciferol concentration was measured at intervals over the course of treatment . RESULTS From a mean baseline value of 70.3 nmol/L , equilibrium concentrations of serum 25-hydroxycholecalciferol changed during the winter months in direct proportion to the dose , with a slope of approximately 0.70 nmol/L for each additional 1 micro g cholecalciferol input . The calculated oral input required to sustain the serum 25-hydroxycholecalciferol concentration present before the study ( ie , in the autumn ) was 12.5 micro g ( 500 IU)/d , whereas the total amount from all sources ( supplement , food , tissue stores ) needed to sustain the starting 25-hydroxycholecalciferol concentration was estimated at approximately 96 micro g ( approximately 3800 IU)/d . By difference , the tissue stores provided approximately 78 - 82 micro g/d . CONCLUSIONS Healthy men seem to use 3000 - 5000 IU cholecalciferol/d , apparently meeting > 80 % of their winter cholecalciferol need with cutaneously synthesized accumulations from solar sources during the preceding summer months . Current recommended vitamin D inputs are inadequate to maintain serum 25-hydroxycholecalciferol concentration in the absence of substantial cutaneous production of vitamin",
"BACKGROUND Little is known about the relative effectiveness of calcium supplementation from food or pills with or without vitamin D supplementation for bone mass accrual during the rapid growth period . OBJECTIVE The purpose was to examine the effects of both food-based and pill supplements of calcium and vitamin D on bone mass and body composition in girls aged 10 - 12 y. DESIGN This placebo-controlled intervention trial r and omly assigned 195 healthy girls at Tanner stage I-II , aged 10 - 12 y , with dietary calcium intakes 1 of 4 groups : calcium ( 1000 mg ) + vitamin D3 ( 200 IU ) , calcium ( 1000 mg ) , cheese ( 1000 mg calcium ) , and placebo . Primary outcomes were bone indexes of the hip , spine , and whole body by dual-energy X-ray absorptiometry and of the radius and tibia by peripheral quantitative computed tomography . RESULTS With the use of intention-to-treat or efficacy analysis , calcium supplementation with cheese result ed in a higher percentage change in cortical thickness of the tibia than did placebo , calcium , or calcium + vitamin D treatment ( P = 0.01 , 0.038 , and 0.004 , respectively ) and in higher whole-body bone mineral density than did placebo treatment ( P = 0.044 ) when compliance was > 50 % . With the use of a hierarchical linear model with r and om effects to control for growth velocity , these differences disappeared . CONCLUSIONS Increasing calcium intake by consuming cheese appears to be more beneficial for cortical bone mass accrual than the consumption of tablets containing a similar amount of calcium . Diverse patterns of growth velocity may mask the efficacy of supplementation in a short-term trial of children transiting through puberty",
"The effect of small calcium and vitamin D supplements on mineral metabolism in normal persons is unclear . To investigate the biochemical response to these medications , we administered 1000 mg Ca and 25 micrograms cholecalciferol per day or a placebo to 92 normal men for 1 y. The Ca and cholecalciferol were tolerated well . 25-Hydroxycholecalciferol [ 25-(OH)D ] and 24,25-dihydroxycholecalciferol [ 24,25-(OH)2D ] levels rose in treated subjects ; there was no definite change in 1,25-(OH)2D concentrations . The average difference in 25-(OH)D levels between treated and untreated subjects was 30 nmol/L at 1 y. Fasting serum Ca , alkaline phosphatase , creatinine , and parathyroid hormone levels and the fasting urinary excretion of Ca , phosphorus and cAMP , were not affected . However , 24-h urinary Ca excretion was higher in the supplemented group ( 3.5 + /- 1.9 vs 4.7 + /- 1.7 mmol/d , p = 0.006 ) . Serum P concentrations were slightly higher in the supplemented group at 1 y. In normal men small calcium and cholecalciferol supplements are safe , provide adequate vitamin D nutrition and apparently increase net gastrointestinal Ca absorption",
"Vitamin D metabolism in elderly individuals can be compromised by several mechanisms . We previously described reduced concentrations of 1,25-dihydroxyvitamin D [ 1,25(OH)2D ] in 30 % of elderly nursing home residents . The present study assesses the effect of vitamin D supplementation on 25-hydroxyvitamin D [ 25(OH)D ] and 1,25(OH)2D . We performed a double-blind study in which 30 elderly nursing home residents were r and omly given either 50 micrograms vitamin D or a placebo daily for 6 wk . Vitamin D metabolites , immunometrically assayed parathyroid hormone ( IRMA-PTH ) , ionized calcium , and bone Gla hormone ( BGP ) were measured in serum at baseline and biweekly for 6 wk . Serum 25(OH)D concentrations increased significantly ( P less than 0.0001 ) over the 6 wk in the treatment group but were unchanged in the placebo group . Serum 1,25(OH)2D , ionized calcium , BGP , and PTH were not significantly altered by the supplement . We conclude that vitamin D supplementation results in an increase in circulating 25(OH)D but not 1,25(OH)2D ; however , the long-term effect on bone mineral metabolism remains unclear",
"In all species tested , except humans , biological differences between vitamins D2 and D3 are accepted as fact . To test the presumption of equivalence in humans , we compared the ability of equal molar quantities of vitamin D2 or D3 to increase serum 25-hydroxyvitamin D [ 25(OH)D ] , the measure of vitamin D nutrition . Subjects took 260 nmol ( approximately 4000 IU ) vitamin D2 ( n=17 ) or vitamin D3 ( n=55 ) daily for 14 d. 25(OH)D was assayed with a method that detects both the vitamin D2 and D3 forms . With vitamin D3 , mean ( + /-SD ) serum 25(OH)D increased from 41.3+/-17.7 nmol/L before to 64.6+/-17.2 nmol/L after treatment . With vitamin D2 , the 25(OH)D concentration went from 43.7+/-17.7 nmol/L before to 57.4+/-13.0 nmol/L after . The increase in 25(OH)D with vitamin D3 was 23.3+/-15.7 nmol/L , or 1.7 times the increase obtained with vitamin D2 ( 13.7+/-11.4 nmol/L ; P=0.03 ) . There was an inverse relation between the increase in 25(OH)D and the initial 25(OH)D concentration . The lowest 2 tertiles for basal 25(OH)D showed larger increases in 25(OH)D : 30.6 and 25.5 nmol/L , respectively , for the first and second tertiles . In the highest tertile [ 25(OH)D > 49 nmol/L ] the mean increase in 25(OH)D was 13.3 nmol/L ( P vitamin D3 shown here may seem small , it is more than what others have shown for 25(OH)D increases when comparing 2-fold differences in vitamin D3 dose . The assumption that vitamins D2 and D3 have equal nutritional value is probably wrong and should be reconsidered",
"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",
"ABSTRACT . Fifty‐one healthy prepubertal schoolchildren were followed for 13 months in a double blind study . Twenty‐four of them were supplemented with 400 IU of vitamin D2 5–7 times weekly , while 27 received a placebo . The children were examined in winter both at the beginning and at the end of the study , and in the middle of the study in autumn . Mean 25‐hydroxyvitamin D levels in the supplemented group were significantly higher than those in the placebo group both in autumn and in winter , when the study ended . The vitamin D supplementation did not , however , affect other vitamin D metabolites , serum calcium , albumin , inorganic phosphorus , parathyroid hormone concentrations or alkaline phosphatase activity . Moreover , the supplementation caused no alterations in the weight or height gain or bone mineral content of the distal radius of the children , and thus sub clinical rickets could not be shown",
"OBJECTIVES To determine the effect of four vitamin D supplement doses on falls risk in elderly nursing home residents . DESIGN Secondary data analysis of a previously conducted r and omized clinical trial . SETTING Seven hundred twenty-five-bed long-term care facility . PARTICIPANTS One hundred twenty-four nursing home residents ( average age 89 ) . INTERVENTION Participants were r and omly assigned to receive one of four vitamin D supplement doses ( 200 IU , 400 IU , 600 IU , or 800 IU ) or placebo daily for 5 months . MEASUREMENTS Number of fallers and number of falls assessed using facility incident tracking data base . RESULTS Over the 5-month study period , the proportion of participants with falls was 44 % in the placebo group ( 11/25 ) , 58 % ( 15/26 ) in the 200 IU group , 60 % ( 15/25 ) in the 400 IU group , 60 % ( 15/25 ) in the 600 IU group , and 20 % ( 5/23 ) in the 800 IU group . Participants in the 800 IU group had a 72 % lower adjusted-incidence rate ratio of falls than those taking placebo over the 5 months ( rate ratio=0.28 ; 95 % confidence interval=0.11 - 0.75 ) . No significant differences were observed for the adjusted fall rates compared to placebo in any of the other supplement groups . CONCLUSION Nursing home residents in the highest vitamin D group ( 800 IU ) had a lower number of fallers and a lower incidence rate of falls over 5 months than those taking lower doses . Adequate vitamin D supplementation in elderly nursing home residents could reduce the number of falls experienced by this high falls risk group",
"Abstract . Calcium malabsorption is common in the elderly and may contribute to the development of age‐related bone loss . To investigate its cause , we have measured radio‐calcium absorption , plasma 25‐hydroxyvitamin D , 1,25‐dihydroxyvitamin D and parathyroid hormone in forty‐eight elderly women with a normal plasma creatinine . Calcium malabsorption was associated with low 25‐hydroxyvitamin D concentrations and was corrected by increasing these into the normal range by treatment with oral 25‐hydroxyvitamin D3 . Treatment also increased 1,25‐dihydroxyvitamin D , and decreased parathyroid hormone concentrations ",
"UNLABELLED Dietary supplementation with vitamin K(1 ) , with vitamin D(3 ) and calcium or their combination , was examined in healthy older women during a 2-year , double-blind , placebo-controlled trial . Combined vitamin K with vitamin D plus calcium was associated with a modest but significant increase in BMC at the ultradistal radius but not at other sites in the hip or radius . INTRODUCTION The putative beneficial role of high dietary vitamin K(1 ) ( phylloquinone ) on BMD and the possibility of interactive benefits with vitamin D were studied in a 2-year double-blind , placebo-controlled trial in healthy Scottish women > or = 60 years of age . MATERIAL S AND METHODS Healthy , nonosteoporotic women ( n = 244 ) were r and omized to receive either ( 1 ) placebo , ( 2 ) 200 microg/day vitamin K(1 ) , ( 3 ) 10 microg ( 400 IU ) vitamin D(3 ) plus 1000 mg calcium/day , or ( 4 ) combined vitamins K(1 ) and D(3 ) plus calcium . Baseline and 6-month measurements included DXA bone mineral scans of the hip and wrist , markers of bone turnover , and vitamin status . Supplementation effects were tested using multivariate general linear modeling , with full adjustment for baseline and potential confounding variables . RESULTS Significant bone mineral loss was seen only at the mid-distal radius but with no significant difference between groups . However , women who took combined vitamin K and vitamin D plus calcium showed a significant and sustained increase in both BMD and BMC at the site of the ultradistal radius . Serum status indicators responded significantly to respective supplementation with vitamins K and D. Over 2 years , serum vitamin K(1 ) increased by 157 % ( p percentage of undercarboxylated osteocalcin ( % GluOC ) decreased by 51 % ( p serum 25-hydroxyvitamin D [ 25(OH)D ] increased by 17 % ( p PTH decreased by 11 % ( p = 0.049 ) . CONCLUSIONS These results provide evidence of a modest synergy in healthy older women from nutritionally relevant intakes of vitamin K(1 ) together with supplements of calcium plus moderate vitamin D(3 ) to enhance BMC at the ultradistal radius , a site consisting of principally trabecular bone . The substantial increase in gamma-carboxylation of osteocalcin by vitamin K may have long-term benefits and is potentially achievable by increased dietary intakes of vitamin K rather than by supplementation",
"UNLABELLED Bone metabolism follows a seasonal pattern with high bone turnover and bone loss during the winter . In a r and omized , open-label 2-year sequential follow-up study of 55 healthy adults , we found that supplementation with oral vitamin D3 and calcium during winter abolished seasonal changes in calciotropic hormones and markers of bone turnover and led to an increase in BMD . Supplementation with oral vitamin D3 and calcium during the winter months seems to counteract the effects of seasonal changes in vitamin D and thus may be beneficial as a primary prevention strategy for age-related bone loss . INTRODUCTION Bone metabolism follows a seasonal pattern characterized by high bone turnover and bone loss during winter . We investigated whether wintertime supplementation with oral vitamin D3 and calcium had beneficial effects on the circannual changes in bone turnover and bone mass . MATERIAL S AND METHODS This prospect i ve study comprised an initial observation period of 12 months ( \" year 1 \" ) , followed by an intervention during parts of year 2 . Fifty-five healthy subjects living in southwestern Germany ( latitude , 49.5 degrees N ) were r and omized into two groups : 30 subjects were assigned to the treatment group and received oral cholecalciferol ( 500 IU/day ) and calcium ( 500 mg/day ) during the winter months of year 2 ( October-April ) , while 25 subjects assigned to the control group obtained no supplements . Primary endpoints were changes in calciotropic hormones [ serum 25(OH)D , 1,25(OH)2D , and parathyroid hormone ] , markers of bone formation ( serum bone-specific alkaline phosphatase ) and of bone resorption ( urinary pyridinoline and deoxypyridinoline ) , and changes in lumbar spine and femoral neck BMD . RESULTS Forty-three subjects completed the study . During year 1 , calciotropic hormones , markers of bone turnover , and BMD varied by season in both groups . During the winter months of year 1 , bone turnover was significantly accelerated , and lumbar spine and femoral BMD declined by 0.3 - 0.9 % . In year 2 , seasonal changes in calciotropic hormones and markers of bone turnover were either reversed or abolished in the intervention group while unchanged in the control cohort . In the subjects receiving oral vitamin D3 and calcium , lumbar and femoral BMD increased significantly ( lumbar spine : + 0.8 % , p = 0.04 versus year 1 ; femoral neck : + 0.1 % , p = 0.05 versus year 1 ) , whereas controls continued to lose bone ( intervention group versus control group : lumbar spine , p = 0.03 ; femoral neck , p = 0.05 ) . CONCLUSIONS Supplementation with oral vitamin D3 and calcium during winter prevents seasonal changes in bone turnover and bone loss in healthy adults . It seems conceivable that annually recurring cycles of low vitamin D and mild secondary hyperparathyroidism during the winter months contributes , at least in part and over many years , to age-related bone loss . Supplementation with low-dose oral vitamin D3 and calcium during winter may be an efficient and inexpensive strategy for the primary prevention of bone loss in northern latitudes",
"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",
"UNLABELLED The effect of vitamin D supplementation on bone mineral augmentation in 212 adolescent girls with adequate calcium intake was studied in a r and omized placebo-controlled setting . Bone mineral augmentation determined by DXA increased with supplementation both in the femur and the lumbar vertebrae in a dose-responsive manner . Supplementation decreased the urinary excretion of resorption markers , but had no impact on formation markers . INTRODUCTION Adequate vitamin D intake protects the elderly against osteoporosis , but there exists no indisputable evidence that vitamin D supplementation would benefit bone mineral augmentation . The aim of this 1-year study was to determine in a r and omized double-blinded trial the effect of 5 and 10 microg vitamin D3 supplementation on bone mineral augmentation in adolescent girls with adequate dietary calcium intake . MATERIAL S AND METHODS Altogether , 228 girls ( mean age , 11.4 + /- 0.4 years ) participated . Their BMC was measured by DXA from the femur and lumbar spine . Serum 25-hydroxyvitamin D [ S-25(OH)D ] , intact PTH ( S-iPTH ) , osteocalcin ( S-OC ) , and urinary pyridinoline ( U-Pyr ) and deoxypyridinoline ( U-Dpyr ) were measured . Statistical analysis was performed both with the intention-to-treat ( IT ) and compliance-based ( CB ) method . RESULTS In the CB analysis , vitamin D supplementation increased femoral BMC augmentation by 14.3 % with 5 microg and by 17.2 % with 10 microg compared with the placebo group ( ANCOVA , p = 0.012 ) . A dose-response effect was observed in the vertebrae ( ANCOVA , p = 0.039 ) , although only with the highest dose . The mean concentration of S-25(OH)D increased ( p S-iPTH or S-OC , but it decreased U-DPyr ( p = 0.042 ) . CONCLUSIONS Bone mineral augmentation in the femur was 14.3 % and 17.2 % higher in the groups receiving 5 and 10 microg of vitamin D , respectively , compared with the placebo group , but only 10 mug increased lumbar spine BMC augmentation significantly . Vitamin D supplementation decreased the concentration of bone resorption markers , but had no impact on bone formation markers , thus explaining increased bone mineral augmentation . However , the positive effects were noted with the CB method but not with IT",
"BACKGROUND A recent meta- analysis found that cholecalciferol ( vitamin D ) should reduce falls by more than 20 % . However , little is known about whether supplemental cholecalciferol plus calcium citrate malate will lower the long-term risk of falling in men , active older individuals , and older individuals with higher 25-hydroxyvitamin D levels . METHODS We studied the effect of 3-year supplementation with cholecalciferol-calcium on the risk of falling at least once in 199 men and 246 women 65 years or older and living at home . Individuals received 700 IU of cholecalciferol plus 500 mg of calcium citrate malate per day or placebo in a r and omized double-blind manner . Subjects were classified as less physically active if physical activity was below the median level . Low 25-hydroxyvitamin D levels were classified as those below 32 ng/mL ( fall . Mean + /- SD baseline 25-hydroxyvitamin D levels were 26.6 + /- 12.7 ng/mL ( 66.4 + /- 31.7 nmol/L ) in women and 33.2 + /- 14.2 ng/mL ( 82.9 + /- 34.9 ) in men . Cholecalciferol-calcium significantly reduced the odds of falling in women ( odds ratio [ OR ] , 0.54 ; 95 % confidence interval [ CI ] , 0.30 - 0.97 ) , but not in men ( OR , 0.93 ; 95 % CI , 0.50 - 1.72 ) . Fall reduction was most pronounced in less active women ( OR , 0.35 ; 95 % CI , 0.15 - 0.81 ) . Baseline 25-hydroxyvitamin D level did not modulate the treatment effect . CONCLUSIONS Long-term dietary cholecalciferol-calcium supplementation reduces the odds of falling in ambulatory older women by 46 % , and especially in less active women by 65 % . Supplementation had a neutral effect in men independent of their physical activity level",
"Specific receptors for vitamin D have been identified in human muscle tissue . Cross-sectional studies show that elderly persons with higher vitamin D serum levels have increased muscle strength and a lower number of falls . We hypothesized that vitamin D and calcium supplementation would improve musculoskeletal function and decrease falls . In a double-blind r and omized controlled trial , we studied 122 elderly women ( mean age , 85.3 years ; range , 63 - 99 years ) in long-stay geriatric care . Participants received 1200 mg calcium plus 800 IU cholecalciferol ( Cal+D-group ; n = 62 ) or 1200 mg calcium ( Cal-group ; n = 60 ) per day over a 12-week treatment period . The number of falls per person ( 0 , 1 , 2 - 5 , 6 - 7 , > 7 falls ) was compared between the treatment groups . In an intention to treat analysis , a Poisson regression model was used to compare falls after controlling for age , number of falls in a 6-week pretreatment period , and baseline 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D serum concentrations . Among fallers in the treatment period , crude excessive fall rate ( treatment - pretreatment falls ) was compared between treatment groups . Change in musculoskeletal function ( summed score of knee flexor and extensor strength , grip strength , and the timed up&go test ) was measured as a secondary outcome . Among subjects in the Cal+D-group , there were significant increases in median serum 25-hydroxyvitamin D ( + 71 % ) and 1,25-dihydroxyvitamin D ( + 8 % ) . Before treatment , mean observed number of falls per person per week was 0.059 in the Cal+D-group and 0.056 in the Cal-group . In the 12-week treatment period , mean number of falls per person per week was 0.034 in the Cal+D-group and 0.076 in the Cal-group . After adjustment , Cal+D-treatment accounted for a 49 % reduction of falls ( 95 % CI , 14 - 71 % ; p crude average number of excessive falls was significantly higher in the Cal-group ( p = 0.045 ) . Musculoskeletal function improved significantly in the Cal+D-group ( p = 0.0094 ) . A single intervention with vitamin D plus calcium over a 3-month period reduced the risk of falling by 49 % compared with calcium alone . Over this short-term intervention , recurrent fallers seem to benefit most by the treatment . The impact of vitamin D on falls might be explained by the observed improvement in musculoskeletal function",
"The long term effects of hormone replacement therapy ( HRT ) and vitamin D3 ( Vit D ) on bone mineral density ( BMD ) were studied . A total of 464 nonosteoporotic early postmenopausal women from the Kuopio Osteoporosis Study ( n = 13100 ) were r and omized to four groups : 1 ) HRT ( sequential combination of 2 mg estradiol valerate and 1 mg cyproterone acetate , 2 ) Vit D3 ( 300 and 100 IU/day during the fifth year ) , 3 ) HRT and Vit D combined , and 4 ) placebo . Lumbar ( L2-L4 ) and femoral neck BMD were determined by dual x-ray absorptiometry ( DXA ) at baseline and after 2.5 and 5 yr of treatment . Intention to treat analysis ( n = 464 ) showed that after 5 yr , lumbar BMD remained unchanged in the HRT and HRT plus Vit D groups [ + 0.2 % ( P = 0.658 ) and + 0.9 % ( P = 0.117 ) , respectively ] , whereas lumbar BMD decreased by 4.6 % in the Vit D group and by 4.5 % in the placebo group ( P loss of femoral neck BMD was less in the HRT ( -1.4 % ; P = 0.005 ) and HRT plus Vit D ( -1.3 % ; P = 0.003 ) groups than in the Vit D and placebo groups ( -4.3 % ; P 370 women who complied with the 5-yr treatment , the effect was more pronounced : lumbar BMD had increased by 1.5 % in the HRT ( P = 0.009 ) and by 1.8 % in the HRT plus Vit D group ( P = 0.005 ) , with a plateau after 2.5 yr , whereas lumbar BMD had decreased in both the Vit D and placebo groups ( 4.6 % and 4.7 % ; P Femoral neck BMD decreased again less in the HRT ( -0.4 % ) and HRT plus Vit D ( -0.6 % ) groups than in the Vit D and placebo groups ( -4.4 % in both ) . This study confirms the positive long term effect of HRT on BMD also seen in intention to treat analysis . The data suggest that low dose vitamin D3 supplementation does not prevent bone loss in healthy , nonosteoporotic , early postmenopausal women , and it confers no benefit additional to that of HRT alone ",
"OBJECTIVES To study the effects of vitamin D supplementation in healthier population s of men . DESIGN : R and omized , controlled trial . SETTING General clinical research center . PARTICIPANTS Sixty-five healthy , community-dwelling men ( mean age+/-st and ard deviation=76+/-4 , range 65 - 87 ) . INTERVENTION Cholecalciferol ( 1,000 IU/d ) or placebo supplementation for 6 months ; all received 500 mg supplemental calcium . MEASUREMENTS Upper and lower extremity muscle strength and power , physical performance and activity , health perception , calcium and vitamin D intake , and biochemical assessment , including 25-hydroxyvitamin D ( 25OHD ) , parathyroid hormone ( PTH ) , and ionized calcium levels . RESULTS The levels of 25OHD increased and PTH decreased in the cholecalciferol group , whereas there were no significant changes in the control group ( P Baseline 25OHD levels correlated with baseline single-leg stance time and physical activity score . Baseline PTH levels correlated with baseline 8-foot walk time and physical activity score . No significant difference in strength , power , physical performance , or health perception was found between groups . CONCLUSION The 25OHD or PTH levels correlated with physical activity and physical performance in older , community-dwelling men with normal 25OHD status . Vitamin D supplementation increased 25OHD levels and decreased PTH levels but did not increase muscle strength or improve physical performance or health perception in this group of healthy , older men . Further investigations of the effects of vitamin D supplementation should focus on individuals with low levels of vitamin",
" Eighteen term , healthy , appropriate for gestational age , breast-fed infants were studied in a double-blind prospect i ve study to determine whether or not supplemental vitamin D affected bone mineralization . All patients were from a single , private pediatric practice . Nine infants were r and omly assigned to a vitamin D supplement of 400 IU/day and nine infants to a placebo . By 12 weeks of age , infants receiving placebo had a significant decrease in bone mineralization and in serum 25-hydroxyvitamin D concentrations compared to the vitamin D-supplemented group . It is not known whether or not the increased BMC at 12 weeks of age in vitamin D-supplemented breast-fed infants is of ultimate value . Supplemental vitamin D may be necessary for optimal bone mineralization in term breast-fed infants . A longer follow-up study and additional analyses are required to make conclusive statements",
"BACKGROUND We conducted a r and omized , placebo-controlled , double-blind trial to test the hypothesis that vitamin D(3 ) supplementation would prevent bone loss in calcium-replete , African American postmenopausal women . METHODS Two hundred eight healthy black postmenopausal women , 50 to 75 years of age , were assigned to receive either placebo or 20 microg/d ( 800 IU ) of vitamin D(3 ) . Calcium supplements were provided to ensure a total calcium intake of 1200 to 1500 mg/d . After 2 years , the vitamin D(3 ) dose was increased to 50 microg/d ( 2000 IU ) in the active group , and the study continued for an additional year . Bone mineral density ( BMD ) was measured every 6 months . Markers of bone turnover , vitamin D metabolites , and parathyroid hormone ( PTH ) levels were measured in serum . RESULTS There were no significant differences in BMD between the active and control groups throughout the study . There was also no relationship between serum 25-hydroxyvitamin D levels attained and rates of bone loss . There was an increase in BMD of the total body , hip , and radius at 1 year in both groups . Over the 3 years , BMD declined at these sites by 0.26 % to 0.55 % per year . The BMD of the lumbar spine increased slightly in the placebo and active groups . There were no persistent changes in serum PTH levels or the markers of bone turnover , although there was a transient decline in PTH in both groups at 3 months . No significant adverse events were attributed to vitamin D supplementation . CONCLUSIONS There was no observed effect of vitamin D(3 ) supplementation on bone loss or bone turnover markers in calcium-replete , postmenopausal African American women . Further studies are needed to determine if these findings are applicable to women of other ethnic groups",
"To examine the relation of the vitamin D status and the remaining estrogen activity with bone turnover and bone mineral density ( BMD ) in elderly women , BMD was measured at both hips using dual-energy X-ray absorptiometry and at the distal radius using single photon absorptiometry , in 330 healthy women aged 70 and over . Vitamin D metabolites , sex hormone binding globulin ( SHBG ) , PTH(1 - 84 ) , osteocalcin , alkaline phosphatase , and hydroxyproline and calcium excretion in 2 h fasting urine were measured . Multiple linear regression was used to adjust for potential confounders . In 65 % of the women , serum 25(OH)D was below 30 nmol/l . Only values below a threshold for 25(OH)D were negatively related to serum PTH(1 - 84 ) ( p = 0.02 , threshold at 25 nmol/l ) and to osteocalcin levels ( p = 0.04 , threshold at 30 nmol/l ) . BMD of the femoral neck and trochanter was positively related to serum 25(OH)D ( left neck p = 0.001 ) with thresholds at 30 nmol/l whereas the distal radius was not ( p = 0.32 ) . Serum PTH was negatively related to BMD at all measurement sites ( all p Serum SHBG , an inverse measure of estrogen activity , was positively related to osteocalcin levels ( p = 0.004 ) and the urinary hydroxyproline/creatinine ratio ( p = 0.002 ) and negatively related to the BMD of the trochanter ( left trochanter p = 0.02 ) and the distal radius ( p = 0.001 ) . We conclude that in elderly women , serum 25(OH)D levels below 30 nmol/l are associated with secondary hyperparathyroidism and increased bone turnover . SHBG is positively related to bone turnover . ( ABSTRACT TRUNCATED AT 250 WORDS",
"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",
"CONTEXT Two reports suggested that vitamin D2 is less effective than vitamin D3 in maintaining vitamin D status . OBJECTIVE Our objective was to determine whether vitamin D2 was less effective than vitamin D3 in maintaining serum 25-hydroxyvitamin D levels or increased the catabolism of 25-hydroxyvitamin D3 . SUBJECTS AND DESIGN This was a r and omized , placebo-controlled , double-blinded study of healthy adults ages 18 - 84 yr who received placebo , 1000 IU vitamin D3 , 1000 IU vitamin D2 , or 500 IU vitamin D2 plus 500 IU vitamin D3 daily for 11 wk at the end of the winter . RESULTS Sixty percent of the healthy adults were vitamin D deficient at the start of the study . The circulating levels of 25-hydroxyvitamin D ( mean+/-sd ) increased to the same extent in the groups that received 1000 IU daily as vitamin D2 ( baseline 16.9+/-10.5 ng/ml ; 11 wk 26.8+/-9.6 ng/ml ) , vitamin D3 ( baseline 19.6+/-11.1 ng/ml ; 11 wk 28.9+/-11.0 ng/ml ) , or a combination of 500 IU vitamin D2 and 500 IU vitamin D3 ( baseline 20.2+/-10.4 ng/ml ; 11 wk 28.4+/-7.7 ng/ml ) . The 25-hydroxyvitamin D3 levels did not change in the group that received 1000 IU vitamin D2 daily . The 1000 IU dose of vitamin D2 or vitamin D3 did not raise 25-hydroxyvitamin D levels in vitamin D-deficient subjects above 30 ng/ml . CONCLUSION A 1000 IU dose of vitamin D2 daily was as effective as 1000 IU vitamin D3 in maintaining serum 25-hydroxyvitamin D levels and did not negatively influence serum 25-hydroxyvitamin D3 levels . Therefore , vitamin D2 is equally as effective as vitamin D3 in maintaining 25-hydroxyvitamin D status",
"BACKGROUND Elderly people who have a fracture are at high risk of another . Vitamin D and calcium supplements are often recommended for fracture prevention . We aim ed to assess whether vitamin D3 and calcium , either alone or in combination , were effective in prevention of secondary fractures . METHODS In a factorial- design trial , 5292 people aged 70 years or older ( 4481 [ 85 % ] of whom were women ) who were mobile before developing a low-trauma fracture were r and omly assigned 800 IU daily oral vitamin D3 , 1000 mg calcium , oral vitamin D3 ( 800 IU per day ) combined with calcium ( 1000 mg per day ) , or placebo . Participants who were recruited in 21 UK hospitals were followed up for between 24 months and 62 months . Analysis was by intention-to-treat and the primary outcome was new low-energy fractures . FINDINGS 698 ( 13 % ) of 5292 participants had a new low-trauma fracture , 183 ( 26 % ) of which were of the hip . The incidence of new , low-trauma fractures did not differ significantly between participants allocated calcium and those who were not ( 331 [ 12.6 % ] of 2617 vs 367 [ 13.7 % ] of 2675 ; hazard ratio ( HR ) 0.94 [ 95 % CI 0.81 - 1.09 ] ) ; between participants allocated vitamin D3 and those who were not ( 353 [ 13.3 % ] of 2649 vs 345 [ 13.1 % ] of 2643 ; 1.02 [ 0.88 - 1.19 ] ) ; or between those allocated combination treatment and those assigned placebo ( 165 [ 12.6 % ] of 1306 vs 179 [ 13.4 % ] of 1332 ; HR for interaction term 1.01 [ 0.75 - 1.36 ] ) . The groups did not differ in the incidence of all-new fractures , fractures confirmed by radiography , hip fractures , death , number of falls , or quality of life . By 24 months , 2886 ( 54.5 % ) of 5292 were still taking tablets , 451 ( 8.5 % ) had died , 58 ( 1.1 % ) had withdrawn , and 1897 ( 35.8 % ) had stopped taking tablets but were still providing data for at least the main outcomes . Compliance with tablets containing calcium was significantly lower ( difference : 9.4 % [ 95 % CI 6.6 - 12.2 ] ) , partly because of gastrointestinal symptoms . However , potentially serious adverse events were rare and did not differ between groups . INTERPRETATION The findings do not support routine oral supplementation with calcium and vitamin D3 , either alone or in combination , for the prevention of further fractures in previously mobile elderly people",
"Objectives : This study was conducted to determine whether there are age differences in the plasma parent vitamin D and 25-hydroxyvitamin D ( 25OHD ) responses to eight weeks of supplementation with 20 μg/day of vitamin D3 . Methods : Twenty-five healthy young men ( age 18–35 ) and 25 healthy older men ( 62–79 ) were r and omly assigned to supplementation with 20 μg/day of vitamin D3 or to no intervention and followed for eight weeks . Plasma vitamin D3 was measured by high performance liquid chromatography and 25OHD was measured by competitive protein binding . Results : Both young and old men in the supplemented group had pronounced , rapid and similar increases in plasma vitamin D3 , whereas vitamin D3 concentrations were stable in the control group . By the end of the eight-week adaptation period , plasma vitamin D3 of young and old men had increased by 4.3 and 6.2 nmol/L respectively . In the supplemented group , mean 25OHD concentrations of both the young and old men increased during the study , and the magnitude of the change after eight weeks was nearly identical in the two age groups ( 22.5 and 22.1 nmol/L in the young and the old men , respectively ) . In the control group there was a modest decrease in 25OHD of both the young and old men . Conclusions : There appears to be no age-related impairment among men in the absorption or metabolism of 20 μg/day of vitamin D3 taken orally for at least eight weeks",
"The aim of this study was to determine whether early changes in bone markers could predict long-term response in bone mineral density ( BMD ) after calcium ( 500 mg ) and vitamin D ( 400 IU ) supplementation twice daily in ambulatory elderly women with vitamin D insufficiency ( 25-hydroxyvitamin D , to receive either the supplementation ( n = 95 ) or a placebo ( n = 97 ) in a double-blind , controlled clinical trial for 1 yr . In comparison with the placebo group , supplementation significantly increased BMD , normalized 25-hydroxyvitamin D and significantly decreased intact PTH and bone remodeling markers . The initial values of telopeptide cross-links were correlated with improvement in total body BMD [ urinary N-telopeptides ( NTX ) , r = 0.38 ; C-telopeptides ( CTX ) , r = 0.32 ; serum CTX , r = 0.28 ] , and the 3-month changes in the same markers were correlated with improvement in total body ( urinary N-telopeptides , r = -0.29 ; serum CTX , r = -0.26 ) and vertebral BMD ( CTX , r = -0.26 ; all P BMD in elderly women with vitamin D insufficiency receiving calcium and vitamin D supplementation",
"Background : Vitamin D insufficiency poses a problem in many parts of the world , the elderly being an especially vulnerable group . This insufficiency results from an inadequate amount of sunshine and a low dietary intake of vitamin D. Typically , insufficiency is accompanied with high intact parathyroid hormone , ( S-iPTH ) concentrations . Aims of the Study : We studied how serum 25-hydroxy vitamin D ( S-25-OHD ) concentrations respond to different doses of vitamin D3 supplementation . Secondly to determine the smallest efficient dose to maintain serum 25-OHD concentration above the insufficiency level . We also studied which dose would be efficient in decreasing S-iPTH concentration in these subjects . Subjects and Methods : Forty-nine 65- to 85-year-old women participated . The women were r and omly assigned into one of four groups receiving 0 ( placebo ) , 5 , 10 or 20 μg of vitamin D3 daily for 12 weeks . Fasting morning blood was drawn at the beginning of the study , and thereafter every second week . Calciotropic variables were assessed from serum and urine sample s. Results : The S-25-OHD concentration increased significantly ( p Equilibrium in S-25-OHD concentration was reached in all groups after 6 weeks of supplementation at 57.7 ( 8.9 ) nmol/L , 59.9 ( 8.9 ) nmol/L and 70.9 ( 8.9 ) nmol/L in the groups with increasing vitamin D supplementation . The dose-response to supplementation decreased with increasing vitamin D status at baseline , r = −0.513 , p = 0.002 . S-iPTH tended to decrease in those with highest dose response to supplementation . Conclusions : A clear dose response was noted in S-25-OHD to different doses of vitamin D3 . The recommended dietary intake of 15 μg is adequate to maintain the S-25-OHD concentration around 40–55 nmol/L during winter , but if the optimal S-25-OHD is higher than that even higher vitamin D intakes are needed . Interestingly , subjects with lower vitamin D status at baseline responded more efficiently to supplementation than those with more adequate status",
"BACKGROUND Knowledge gaps have contributed to considerable variation among international dietary recommendations for vitamin D. OBJECTIVE We aim ed to establish the distribution of dietary vitamin D required to maintain serum 25-hydroxyvitamin D [ 25(OH)D ] concentrations above several proposed cutoffs ( ie , 25 , 37.5 , 50 , and 80 nmol/L ) during wintertime after adjustment for the effect of summer sunshine exposure and diet . DESIGN A r and omized , placebo-controlled , double-blind 22-wk intervention study was conducted in men and women aged 20 - 40 y ( n = 238 ) by using different supplemental doses ( 0 , 5 , 10 , and 15 microg/d ) of vitamin D(3 ) throughout the winter . Serum 25(OH)D concentrations were measured by using enzyme-linked immunoassay at baseline ( October 2006 ) and endpoint ( March 2007 ) . RESULTS There were clear dose-related increments ( P serum 25(OH)D with increasing supplemental vitamin D(3 ) . The slope of the relation between vitamin D intake and serum 25(OH)D was 1.96 nmol x L(-1 ) x microg(-1 ) intake . The vitamin D intake that maintained serum 25(OH)D concentrations of > 25 nmol/L in 97.5 % of the sample was 8.7 microg/d . This intake ranged from 7.2 microg/d in those who enjoyed sunshine exposure , 8.8 microg/d in those who sometimes had sun exposure , and 12.3 microg/d in those who avoided sunshine . Vitamin D intakes required to maintain serum 25(OH)D concentrations of > 37.5 , > 50 , and > 80 nmol/L in 97.5 % of the sample were 19.9 , 28.0 , and 41.1 microg/d , respectively . CONCLUSION The range of vitamin D intakes required to ensure maintenance of wintertime vitamin D status [ as defined by incremental cutoffs of serum 25(OH)D ] in the vast majority ( > 97.5 % ) of 20 - 40-y-old adults , considering a variety of sun exposure preferences , is between 7.2 and 41.1 microg/d"
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INTRODUCTION The increasing prevalence of type 2 diabetes mellitus ( T2DM ) presents a significant burden on affected individuals and healthcare systems internationally . There is , however , no agreed vali date d measure to infer diabetes severity from electronic health records ( EHRs ) . We aim to quantify T2DM severity and vali date it using clinical adverse outcomes . METHODS AND ANALYSIS Primary care data from the Clinical Practice Research Data link , linked hospitalisation and mortality records between April 2007 and March 2017 for patients with T2DM in Engl and will be used to develop a clinical algorithm to grade T2DM severity . The EHR-based algorithm will incorporate main risk factors ( severity domains ) for adverse outcomes to stratify T2DM cohorts by baseline and longitudinal severity scores . Provisionally , T2DM severity domains , identified through a systematic review and expert opinion , are : diabetes duration , glycated haemoglobin , microvascular complications , comorbidities and coprescribed treatments . Severity scores will be developed by two approaches : ( 1 ) calculating a count score of severity domains ; ( 2 ) through hierarchical stratification of complications . Regression models estimates will be used to calculate domains weights . Survival analyses for the association between weighted severity scores and future outcomes -cardiovascular events , hospitalisation ( diabetes-related , cardiovascular ) and mortality ( diabetes-related , cardiovascular , all-cause mortality)-will be performed as statistical validation . The proposed EHR-based approach will quantify the T2DM severity for primary care performance management and inform the methodology for measuring severity of other primary care-managed chronic conditions . We anticipate that the developed algorithm will be a practical tool for practitioners , aid clinical management decision-making , inform stratified medicine , support future clinical trials and contribute to more effective service planning and policy-making . ETHICS AND DISSEMINATION The study protocol was approved by the Independent Scientific Advisory Committee . Some data were presented at the National Institute for Health Research School for Primary Care Research Showcase , September 2017 , Oxford , UK and the Diabetes UK Professional Conference March 2018 , London , UK . The study findings will be disseminated in relevant academic conferences and peer- review ed journals
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"Objectives The Italian project MATRICE aim ed to assess how well cases of type 2 diabetes ( T2DM ) , hypertension , ischaemic heart disease ( IHD ) and heart failure ( HF ) and their levels of severity can be automatically extracted from the Health Search /CSD Longitudinal Patient Data base ( HSD ) . From the medical records of the general practitioners ( GP ) who volunteered to participate , cases were extracted by algorithms based on diagnosis codes , keywords , drug prescriptions and results of diagnostic tests . A r and om sample of identified cases was vali date d by interviewing their GPs . Setting HSD is a data base of primary care medical records . A panel of 12 GPs participated in this validation study . Participants 300 patients were sample d for each disease , except for HF , where 243 patients were assessed . Outcome measures The positive predictive value ( PPV ) was assessed for the presence/absence of each condition against the GP 's response to the question naire , and Cohen 's κ was calculated for agreement on the severity level . Results The PPV was 100 % ( 99 % to 100 % ) for T2DM and hypertension , 98 % ( 96 % to 100 % ) for IHD and 55 % ( 49 % to 61 % ) for HF . Cohen 's kappa for agreement on the severity level was 0.70 for T2DM and 0.69 for hypertension and IHD . Conclusions This study shows that individuals with T2DM , hypertension or IHD can be validly identified in HSD by automated identification algorithms . Automatic queries for levels of severity of the same diseases compare well with the corresponding clinical definitions , but some misclassification occurs . For HF , further research is needed to refine the current algorithm",
"This Diabcare-Asia project was initiated to study the status of diabetes care and prevalence of diabetic complications in Asia and this study was done to evaluate the above in primary private healthcare in Malaysia . A total of 49 private clinics participated in this study from which a total of 438 patients were included and analysed . The majority of patients ( 96.5 % ) had type 2 diabetes mellitus and 81.4 % had BMI > or = 23 kg/m2 . Only 12.0 % of the patients had their HbA1c measured in the preceding 12 months . As for glycaemic control only 20 % of the patients had HbA1c lipid levels , only 12.3 % of the patients had total cholesterol HDL-cholesterol > 1.2 mmol/L and 49.8 % had triglycerides lipid lowering therapy . As for blood pressure , 55.9 % of the patients had systolic pressure > or = 140 mmHg and 40.9 % had diastolic pressure > or = 90 mmHg . However , only 32.4 % of the patients were on antihypertensive medication . Only 37.4 % of the patients admitted to adhering to diabetic diet regularly and 32.0 % exercised regularly . As for glucose monitoring only 6.9 % of the patients did home blood glucose monitoring and 6.2 % did home urine glucose . There was also a high complication rate with the commonest being neuropathy ( 30.1 % ) followed by background retinopthy ( 23.5 % ) , albuminuria ( 22.9 % ) and microalbuminuria ( 20.4 % ) . In conclusion , the majority of diabetic patients treated at the primary care level were not satisfactorily controlled and this was associated with a high prevalence of complications . There is an urgent need to educate both patients and health care personnel on the importance of achieving the clinical targets and greater effort must be made to achieve these targets",
"OBJECTIVES To investigate prospect ively the incidence , certain predictors and outcomes of type 2 diabetes ( DM ) , as well as to determine its prevalence cross-sectionally , in a representative sample of Turkish men and women . METHODS Prospect i ve evaluation of 3401 male and female participants ( aged 48.2 + /-12 years ) . Follow-up constituted 19,050 person-years . Individuals with DM were diagnosed with criteria of the American Diabetes Association . Fatal and nonfatal coronary heart disease ( CHD ) was identified by clinical findings and Minnesota coding of resting electrocardiograms . Cut-points of > or = 95 cm in males and > or = 91 cm in females were selected for abdominal obesity . For prospect i ve evaluations , cases with DM or CHD were excluded . RESULTS Prevalence of DM in Turkish adults was estimated as 2.89 million ( 11.0 % of the population aged > or = 35 years ) . Over a mean follow-up of 5.9 years , incident DM developed in 223 subjects , yielding an incidence per 1000 person-years of 11.0 in women and 12.4 in men . This corresponded to a 300,000 annual incidence . Following risk parameter levels but not HDL-cholesterol were significantly elevated at baseline in subjects developing DM compared to those without : age ( 5 years ) , waist girth ( 7 cm ) , blood pressure ( 12/6 mmHg ) , apolipoprotein B ( 7 mg/dl ) , total cholesterol ( 14 mg/dl ) , and fasting triglycerides ( only in women , 52 mg/dl ) . Abdominal obesity ( RR 2.61 [ 95%CI 1.87 ; 3.63 ] ) and age in both genders , hypertension ( RR 1.81 [ 95%CI 1.10 ; 2.98 ] ) and low HDL-cholesterol in men alone were significant independent predictors of DM . Diabetes mellitus was a significant and independent predictor of fatal and nonfatal CHD , with a RR of 1.81 ( 95%CI 1.19 ; 2.75 ) , after adjustment for sex , age , hypertension , waist circumference , serum total cholesterol and smoking status . CONCLUSIONS The annual incidence of DM in Turkey rises very rapidly , currently st and s at 300,000 , and , hence , its prevalence also rises correspondingly . Insulin resistance appears to be a weak determinant of DM in Turkish women while abdominal obesity is the main determinant . Multivariately adjusted DM is a significant independent predictor of fatal and nonfatal CHD . These observations emphasize that measures to reverse or stop the \" epidemic \" of abdominal obesity are severely required",
"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",
"BACKGROUND Education leads to better health-related decisions and protective behaviors , being especially important for patients with chronic conditions . Self-management education programs have been shown to be beneficial for patients with different chronic conditions and to have a higher impact on health outcomes than does didactic education . OBJECTIVE To investigate improvements in glycemic control ( measured by glycated hemoglobin A1c ) in patients with type 2 diabetes mellitus . METHODS Our comparative trial involved one group of patients receiving patient-centered education and another receiving didactic education . We dealt with selection bias issues , estimated the different impact of both programs , and vali date d our analysis using quantile regression techniques . RESULTS We found evidence of better mean glycemic control in patients receiving the patient-centered program , which engaged better patients . Nevertheless , that differential impact is nonmonotonic . Patients initially at the healthy range at the patient-centered program maintained their condition better . Patients close to , but not within , the healthy range benefited equally from attending either program . Patients with very high glycemic level benefited significantly more from attending the patient-centered program . Finally , patients with the worst initial glycemic control ( far from the healthy range ) improved equally their diabetic condition , regardless of which program they attended . CONCLUSIONS Different patients are sensitive to different categories of education programs . The optimal , cost-effective design of preventative programs for patients with chronic conditions needs to account for the different impact in different \" patient categories . \" This implies stratifying patients and providing the appropriate preventative education program , or looking for alternative policy implementations for unresponsive patients who have the most severe condition and are the most costly"
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41172314-06ff-11f0-808a-c43d1ab1c353
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Background Overactive bladder (OAB)/ storage lower urinary tract symptoms ( LUTS ) have a high prevalence affecting up to 90 % of men over 80 years . The role of sufficient therapies appears crucial . In the present review , we analyzed the mechanism of action of tolterodine extended-release ( ER ) with the aim to clarify its efficacy and safety profile , as compared to other active treatments of OAB/storage LUTS . Methods A wide Medline search was performed including the combination of following words : “ LUTS ” , “ BPH ” , “ OAB ” , “ antimuscarinic ” , “ tolterodine ” , “ tolterodine ER ” . IPSS , IPSS storage sub-score and IPSS QoL ( International Prostate Symptom Score ) were the vali date d efficacy outcomes . In addition , the numbers of urgency episodes/24 h , urgency incontinence episodes/24 h , incontinence episodes/24 h and pad use were considered . We also evaluated the most common adverse events ( AEs ) reported for tolterodine ER . Results Of 128 retrieved articles , 109 were excluded . The efficacy and tolerability of tolterodine ER Vs . tolterodine IR have been evaluated in a multicenter , double-blind , r and omized placebo controlled study in 1529 patients with OAB . A 71 % mean reduction in urgency incontinence episodes was found in the tolterodine ER group compared to a 60 % reduction in the tolterodine IR ( p clinical efficacy of α-blocker/tolterodine combination therapy . In patients with large prostates ( prostate volume > 29 cc ) only the combination therapy significantly reduced 24-h voiding frequency ( 2.8 vs. 1.7 with tamsulosin , 1.4 with tolterodine , or 1.6 with placebo ) . A recent meta- analysis evaluating tolterodine in comparison with other antimuscarinic drugs demonstrated that tolterodine ER was significantly more effective than placebo in reducing micturition/24 h , urinary leakage episodes/24 h , urgency episodes/24 h , and urgency incontinence episodes/24 h. With regard to adverse events , tolterodine ER was associated with a good adverse event profile result ing in the third most favorable antimuscarinic . Antimuscarinic drugs are the mainstay of pharmacological therapy for OAB / storage LUTS ; several studies have demonstrated that tolterodine ER is an effective and well tolerated formulation of this class of treatment . Conclusion Tolterodine ER result ed effective in reducing frequency urgency and nocturia and urinary leakage in male patients with OAB/storage LUTS . Dry mouth and constipation are the most frequently reported adverse events
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"The aim of this study was to determine the pharmacokinetics , pharmacodynamics , and safety of tolterodine following single oral and intravenous doses in healthy volunteers . A secondary aim was to identify major urinary metabolites and determine mass balance . Single oral doses of 0.2 , 0.4 , 0.8 , 1.6 , 3.2 , 6.4 , and 12.8 mg of tolterodine ( as the tartrate salt ) were given to 17 healthy male volunteers . Two intravenous doses ( 0.64 and 1.28 mg ) were administered to 8 of the volunteers and mass balance was studied after a single oral dose of 5 mg (14C)-tolterodine in 6 subjects . Tolterodine was rapidly absorbed following oral administration ( time to peak serum concentration 0.9 + /- 0.4 h ) . The absolute bioavailability was highly variable , ranging from 10 to 70 % . The volume of distribution at steady-state ranged from 0.9 to 1.6 l/kg and systemic clearance ranged from 0.23 to 0.52 l/h/kg , which result ed in a terminal half-life of 2 - 3 h. Tolterodine exhibited high first-pass metabolism and 2 hepatic metabolic pathways were identified : oxidation and dealkylation . Independent of route of administration , excretion of radioactivity into urine and feces was 77 + /- 4.0 % and 17 + /- 3.5 % , respectively . Tolterodine decreased stimulated salivation after 3.2 mg , increased heart rate after 6.4 mg , and nearpoint of vision after 12.8 mg . Six of 8 subjects reported micturition difficulties after a dose of 12.8 mg . The lack of a direct relationship between tolterodine serum concentrations and effects on stimulated salivation suggested the presence of pharmacologically active metabolite(s )",
"To determine whether cytochrome P450 2D6 ( CYP2D6 ) is involved in the metabolism of tolterodine by investigating potential differences in pharmacokinetics and pharmacodynamics ( heart rate , accommodation , and salivation ) of tolterodine and its 5‐hydroxymethyl metabolite between poor metabolizers and extensive metabolizers of debrisoquin ( INN , debrisoquine )",
"OBJECTIVES To evaluate the efficacy and tolerability of a new extended-release ( ER ) , once-daily , capsule formulation of tolterodine , relative to placebo and the existing immediate-release ( IR ) , twice-daily , tablet formulation , for treatment of the overactive bladder . METHODS This was a double-blind , multicenter , r and omized , placebo-controlled trial . One thous and five hundred twenty-nine patients ( 81 % women ) with urinary frequency ( eight or more micturitions every 24 hours ) and urge incontinence ( five or more episodes per week ) were r and omized to oral therapy with tolterodine ER 4 mg once daily ( n = 507 ) , tolterodine IR 2 mg twice daily ( n = 514 ) , or placebo ( n = 508 ) for 12 weeks . Efficacy was assessed at the end of the treatment period on the basis of the micturition diary variables . Tolerability and safety were assessed by evaluating the adverse events , electrocardiogram parameters , laboratory values , and treatment withdrawals . RESULTS Tolterodine ER 4 mg once daily ( P = 0.0001 ) and tolterodine IR 2 mg twice daily ( P = 0.0005 ) both significantly reduced the mean number of urge incontinence episodes per week compared with placebo . The median reduction in these episodes as a percentage of the baseline values was 71 % for tolterodine ER , 60 % for tolterodine IR , and 33 % for placebo . The ER formulation was 18 % more effective than the IR formulation ( P tolterodine was also associated with statistically significant improvements in all other micturition diary variables compared with placebo . For both formulations , the mean decreases in micturition frequency ( P pad usage ( P mean volume voided per micturition increased ( P = 0.0001 ) . The rate of dry mouth ( of any severity ) was 23 % for tolterodine ER , 30 % for tolterodine IR , and 8 % for placebo . The overall dry mouth rate for patients taking tolterodine ER was 23 % lower than for tolterodine IR ( P of severe dry mouth in the ER group was only 1.8 % . The rates of withdrawal were comparable for the two active groups and the placebo group . No safety concerns were noted . CONCLUSIONS Tolterodine ER 4 mg once daily is effective and well tolerated in the treatment of overactive bladder with no safety concerns . Tolterodine ER demonstrated an improved efficacy for reducing urge incontinence episodes and a lower frequency of dry mouth compared with the existing IR twice-daily formulation",
"OBJECTIVE To compare the efficacy and tolerability of extended-release formulations of oxybutynin chloride and tolterodine tartrate in women with overactive bladder . PATIENTS AND METHODS The OPERA ( Overactive bladder : Performance of Extended Release Agents ) trial was a r and omized , double-blind , active-control study performed at 71 US study centers from November 21 , 2000 , to October 18,2001 . Extended-release formulations of oxybutynin at 10 mg/d or tolterodine at 4 mg/d were given for 12 weeks to women with 21 to 60 urge urinary incontinence ( UUI ) episodes per week and an average of 10 or more voids per 24 hours . Episodes of UUI ( primary end point ) , total ( urge and nonurge ) incontinence , and micturition were recorded in 24-hour urinary diaries at baseline and at weeks 2 , 4 , 8 , and 12 and compared . Adverse events were also evaluated . RESULTS Improvements in weekly UUI episodes were similar for the 790 women who received extended-release formulations of oxybutynin ( n = 391 ) or tolterodine ( n = 399 ) . Oxybutynin was significantly more effective than tolterodine in reducing micturition frequency ( P = .003 ) , and 23.0 % of women taking oxybutynin reported no episodes of urinary incontinence compared with 16.8 % of women taking tolterodine ( P = .03 ) . Dry mouth , usually mild , was more common with oxybutynin ( P = .02 ) . Adverse events were generally mild and occurred at low rates , with both groups having similar discontinuation of treatment due to adverse events . CONCLUSIONS Reductions in weekly UUI and total incontinence episodes were similar with extended-release formulations of oxybutynin and tolterodine . In the oxybutynin group , micturition frequency was significantly lower , and the percentage of women reporting no urinary incontinence episodes was significantly higher compared with the tolterodine group . Dry mouth was more common with oxybutynin , but tolerability was otherwise comparable , including adverse events involving the central nervous system",
"OBJECTIVES To summarize the efficacy and safety of tolterodine from the pooled data of four multicenter , r and omized , double-blind , placebo-controlled , dose-ranging , parallel-group Phase II studies in patients with urodynamically proved overactive bladder ( detrusor instability or detrusor hyperreflexia ) and to analyze the concentration-effect relation . METHODS After a 1-week run-in period to establish baseline values , 319 patients were r and omized to receive placebo or tolterodine 0.5 , 1 , 2 , or 4 mg twice daily . Micturition diary and urodynamic variables and subjective urinary symptoms were assessed after 2 weeks of treatment . Patients were classified as \" extensive \" or \" poor \" metabolizers of tolterodine on the basis of serum levels of tolterodine . RESULTS A per- protocol analysis of efficacy in 262 patients showed dose-related improvements in micturition diary and urodynamic variables . A dosage of 4 mg twice daily was , however , associated with an increase in residual urinary volume . The incidence of adverse events ( mainly mild or moderate antimuscarinic effects ) was comparable between placebo and tolterodine dosages of 2 mg twice daily . No serious drug-related adverse events were observed , and tolterodine had no clinical ly significant impact on electrocardiographic or laboratory findings . Changes in urodynamic variables were found to be related to the sum of unbound serum concentrations of tolterodine and its major active 5-hydroxymethyl metabolite . In poor and extensive metabolizers of tolterodine , exposure to the sum of these active moieties was similar , and the efficacy and safety profiles were comparable . CONCLUSIONS The results of this pooled data analysis indicate that tolterodine offers an effective treatment for patients with urinary symptoms attributable to overactive bladder . The optimal dosage is 1 to 2 mg twice daily , irrespective of metabolic phenotype",
"Objective To determine the multiple dose pharmacokinetics of a new extended release ( ER ) capsule formulation of tolterodine , compared with the existing immediate release ( IR ) tablet , in healthy volunteers . Design Nonblind , r and omised , 2-way crossover trial . Participants 19 healthy volunteers ( 7 females , 12 males ) , mean age 33 years ( range 18 to 55 years ) . Prior to the study , all volunteers were classified as either extensive or poor metabolisers by cytochrome P450 2D6 genotyping . Methods Volunteers received tolterodine ER 4 mg once daily or tolterodine IR 2 mg twice daily for 6 days ( all doses given as the L-tartrate salt ) . A washout period of 7 days separated the 2 treatments . Serum concentrations of tolterodine , its active 5-hydroxymethyl metabolite ( 5-HM ) and the active moiety ( extensive metabolisers : sum of unbound tolterodine + 5-HM ; poor metabolisers : unbound tolterodine ) were measured for up to 48 hours post-dose on day 6 ( steady state ) . Tolerability was also determined . Results 17 volunteers ( 13 extensive metabolisers , 4 poor metabolisers ) completed the study and were evaluable for both treatment periods . The 90 % confidence interval for the geometric mean ratio of area under the serum concentration-time curve to 24 hours ( AUC24 ) of the active moiety , for all volunteers combined , indicated equivalence for the 2 formulations . Pooled analysis also demonstrated that the peak serum concentration ( Cmax ) of the active moiety following administration of tolterodine ER was around 75 % of that observed for the IR tablet , whereas the trough concentration was around 1.5-fold higher . Overall , the pharmacokinetics of tolterodine ( irrespective of genotype ) and 5-HM ( extensive metabolisers only ) were consistent with sustained drug release over 24 hours . Tolterodine ER was well tolerated . Conclusions The new once daily ER formulation of tolterodine 4 mg shows pharmacokinetic equivalence ( AUC24 ) to the existing IR tablet given at a dose of 2 mg twice daily . Findings of lower Cmax for tolterodine ER may explain the significantly lower rate of dry mouth subsequently observed in patients with overactive bladder",
"Antimuscarinics , used commonly to treat overactive bladder , may differ in their potential to increase heart rate via effects on cardiac muscarinic M2 receptors . This prospect i ve , 3-way crossover , r and omized , double-blind study assessed the heart rate effects of 7 days ' exposure to a nonselective M2/M3 receptor blocker ( tolterodine ; 4 mg/d ) , a highly selective M3 receptor blocker ( darifenacin ; 15 mg/d ) , and placebo in 162 healthy participants ≥50 years . Heart rate was measured by 24-hour Holter monitoring . Tolterodine significantly increased heart rate versus darifenacin and heart rate versus placebo , while darifenacin did not affect heart rate versus placebo . The proportion of participants with an increase in mean heart rate per 24 hours of ≥5 beats per minute was higher with tolterodine than with darifenacin ( P = .0004 ) or with placebo ( P = .0114 ) but did not differ between darifenacin and placebo . The results show that antimuscarinics exert differential effects on heart rate depending on their muscarinic receptor profile . This should be considered when selecting a treatment",
"CONTEXT Men with overactive bladder and other lower urinary tract symptoms may not respond to monotherapy with antimuscarinic agents or alpha-receptor antagonists . OBJECTIVE To evaluate the efficacy and safety of tolterodine extended release ( ER ) , tamsulosin , or both in men who met research criteria for both overactive bladder and benign prostatic hyperplasia . DESIGN , SETTING , AND PARTICIPANTS R and omized , double-blind , placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and , an International Prostate Symptom Score quality -of-life ( QOL ) item score of 3 or higher , a self-rated bladder condition of at least moderate bother , and a bladder diary documenting micturition frequency ( > or=8 micturitions per 24 hours ) and urgency ( > or=3 episodes per 24 hours ) , with or without urgency urinary incontinence . Patients were recruited between November 2004 and February 2006 , and the study was completed May 2006 . INTERVENTIONS Patients were r and omly assigned to receive placebo ( n = 222 ) , 4 mg of tolterodine ER ( n = 217 ) , 0.4 mg of tamsulosin ( n = 215 ) , or both tolterodine ER plus tamsulosin ( n = 225 ) for 12 weeks . MAIN OUTCOME MEASURES Patient perception of treatment benefit , bladder diary variables , International Prostate Symptom Scores , and safety and tolerability were assessed . RESULTS A total of 172 men ( 80 % ) receiving tolterodine ER plus tamsulosin reported treatment benefit by week 12 compared with 132 patients ( 62 % ) receiving placebo ( P tolterodine ER ( P=.48 vs placebo ) . Patients receiving tolterodine ER plus tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence ( -0.88 vs -0.31 , P=.005 ) , urgency episodes without incontinence ( -3.33 vs -2.54 , P=.03 ) , micturitions per 24 hours ( -2.54 vs -1.41 , P micturitions per night ( -0.59 vs -0.39 , P.02 ) . Patients receiving tolterodine ER plus tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score ( -8.02 vs placebo , -6.19 , P=.003 ) and QOL item ( -1.61 vs -1.17 , P=.003 ) . All interventions were well tolerated . The incidence of acute urinary retention requiring catheterization was low ( tolterodine ER plus tamsulosin , 0.4 % ; tolterodine ER , 0.5 % ; tamsulosin , 0 % ; and placebo , 0 % ) . CONCLUSIONS These results suggest that treatment with tolterodine ER plus tamsulosin for 12 weeks provides benefit for men with moderate to severe lower urinary tract symptoms including overactive bladder . Clinical Trials Registration clinical trials.gov Identifier : NCT00147654",
"OBJECTIVE To compare the efficacy and tolerability of tolterodine with that of oxybutynin in patients with an overactive bladder . PATIENTS AND METHODS A r and omized , double-blind , placebo-controlled , parallel group , multinational phase-III study was conducted in urology and gynaecology clinics in the UK , Republic of Irel and and Sweden . The study enrolled 293 patients with urodynamically confirmed bladder overactivity , increased frequency of micturition ( > or = micturitions/24 h ) and symptoms of urgency and /or urge incontinence ( > or = 1 episode/24 h ) . Patients received either tolterodine ( 2 mg twice daily ) or oxybutynin ( 5 mg three times daily ) or placebo . Doses could be reduced , to prevent withdrawal , to 1 mg or 2.5 mg , respectively . The main outcome measures were the mean change from baseline in frequency of micturition/24 h , the number of incontinent episodes/24 h and volume voided per micturition . RESULTS After 12 weeks ' treatment , the mean frequency of micturition decreased by 21 % and 19.5 % in those receiving tolterodine ( n = 118 ) and oxybutynin ( n = 118 ) , respectively , and by 10.5 % in those on placebo ( n = 57 ) . Among those with urge incontinence at baseline ( 75 % of patients ) , the mean number of incontinent episodes decreased by 47 % , 71 % and 19 % , respectively , in those receiving tolterodine , oxybutynin and placebo . The effect of tolterodine and oxybutynin on these two micturition variables was statistically equivalent . There was also a comparable increase in mean volume voided per micturition in the tolterodine ( 27 % ) and oxybutynin groups ( 31 % ) , compared with 7 % in the placebo group . Dry mouth was the most common adverse event and was reported with greater frequency and intensity among patients receiving oxybutynin than among those receiving either tolterodine or placebo . In the oxybutynin group , more patients also withdrew because of adverse events and a greater proportion required dose reduction as a result of adverse events . Despite dose reduction , the frequency of adverse events and the intensity of dry mouth remained higher among those receiving oxybutynin ( 2.5 mg three times daily ) than in patients who remained on tolterodine 2 mg twice daily . CONCLUSION Tolterodine 2 mg twice daily is effective and well tolerated in the treatment of bladder overactivity . Tolterodine was better tolerated than oxybutynin , particularly with respect to the frequency and intensity of dry mouth , but had comparable clinical efficacy . The superior tolerability of tolterodine therefore allows more patients to remain on effective therapy than the current most commonly prescribed agent for the treatment of the overactive bladder",
"OBJECTIVE To determine the efficacy , tolerability , and safety of fesoterodine in subjects with overactive bladder ( OAB ) . METHODS This was a multicentre , r and omised , double-blind , placebo- and active-controlled trial with tolterodine extended release ( ER ) to assess the efficacy and safety of fesoterodine . Eligible subjects ( > or = 18 yr ) with increased micturition frequency and urgency and /or urgency urinary incontinence ( UUI ) were r and omised to placebo , fesoterodine 4 mg , fesoterodine 8 mg , or tolterodine ER 4 mg for 12 wk . The primary efficacy variable was a change from baseline to week 12 in micturitions per 24 h. Co- primary end points included change from baseline to week 12 in UUI episodes per 24 h and Treatment Response ( \" yes \" or \" no , \" based on four-point treatment benefit scale ) . Secondary efficacy variables included mean volume voided per micturition , continent days per week , and number of urgency episodes . RESULTS At the end of treatment , subjects taking fesoterodine 4 and 8 mg had significant ( p placebo in the primary , co- primary , and most secondary efficacy variables . Tolterodine ER ( active control ) also provided significantly greater improvement than placebo for most efficacy variables , confirming the sensitivity of the study design . A more pronounced effect was observed with fesoterodine 8 mg at most end points . CONCLUSIONS Both doses of fesoterodine were significantly better than placebo in improving the symptoms of OAB and produced a significantly greater Treatment Response versus placebo . Efficacy was more pronounced with fesoterodine 8 mg compared with the other treatments . Active treatments were well tolerated",
"OBJECTIVE To investigate the clinical safety and efficacy of two dosages of tolterodine in older patients with symptoms attributable to overactive bladder . DESIGN R and omized , double-blind , placebo-controlled , parallel-group , multinational , phase III study . SETTING Incontinence , older care , urological , and urogynecological clinics in the United Kingdom , France , and the Republic of Irel and . PARTICIPANTS One hundred and seventy-seven older patients ( age > or = 65 years ) with symptoms of urinary urgency , increased frequency of micturition ( > or = 8 micturitions/24 hours ) , and /or urge incontinence ( > or = 1 episode/24 hours ) . INTERVENTION Tolterodine 1 mg or 2 mg twice daily ( bid ) , or placebo , for 4 weeks . MEASUREMENTS Safety and tolerability were evaluated through spontaneously reported adverse events , electrocardiogram , and blood pressure measurements . Efficacy was assessed using micturition diary variables : mean change from baseline in frequency of micturition and number of incontinence episodes/24 hours . RESULTS The mean age of the patient population was 75 years . Overall , > or = 87 % of patients completed the study . Neither dosage of tolterodine was associated with serious drug-related adverse events during the study . No cardiac arrythmogenic events were noted . Dry mouth ( mild to moderate intensity ) was the most common adverse event in both the placebo and tolterodine treatment groups . Three percent of patients in the tolterodine 2 mg bid group discontinued treatment because of dry mouth , compared with 2 % of placebo-treated patients . Compared with placebo , statistically significant decreases in micturition frequency were apparent in both tolterodine treatment groups . Furthermore , patients treated with tolterodine 2 mg bid had statistically significant decreases in urge incontinence episodes/24 hours and increases in volume voided per micturition compared with placebo . CONCLUSION Tolterodine ( taken for 4 weeks ) is safe and shows efficacy , particularly at a dosage of 2 mg bid , in the treatment of older patients with urinary symptoms attributable to overactive bladder",
"BACKGROUND Some men receiving alpha-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder ( OAB ) . OBJECTIVE To evaluate the efficacy of tolterodine extended release ( ER ) in men on alpha-blocker therapy . DESIGN , SETTING , AND PARTICIPANTS This double-blind trial included men aged > or = 40 yr with frequency , urgency , and at least moderate problems reported on the Patient Perception of Bladder Condition ( PPBC ) , despite being on a stable dose of alpha-blocker for > or = 1 mo . INTERVENTIONS Subjects were r and omized to tolterodine ER 4 mg per day or placebo for 12 wk while continuing their prescribed alpha-blocker therapy . MEASUREMENTS At baseline and week 12 , subjects completed the PPBC , International Prostate Symptom Score ( IPSS ) , Overactive Bladder Question naire ( OAB-q ) , and 5-d bladder diaries using the five-point Urinary Sensation Scale ( USS ) . Frequency-urgency sum was defined as the sum of USS ratings for all micturitions . RESULTS AND LIMITATIONS PPBC improvement from baseline to week 12 was reported by 63.6 % and 61.6 % of subjects receiving tolterodine ER plus alpha-blocker and placebo plus alpha-blocker , respectively ; this treatment difference , which was the primary end point , was not statistically significant ( p>0.6699 ) . At week 12 , subjects receiving tolterodine ER plus alpha-blocker had significantly greater improvements versus placebo plus alpha-blocker in 24-h micturitions ( -1.8 vs -1.2 ; p=0.0079 ) and daytime micturitions ( -1.3 vs -0.8 ; p=0.0123 ) ; 24-h urgency episodes ( -2.9 vs -1.8 ; p=0.0010 ) , daytime urgency episodes ( -2.2 vs -1.4 ; p=0.0017 ) , and nocturnal urgency episodes ( -0.5 vs -0.3 ; p=0.0378 ) ; frequency-urgency sum ( -7.8 vs -5.1 ; p=0.0065 ) ; IPSS storage subscale ( -2.6 vs -2.1 ; p=0.0370 ) ; and OAB-q symptom bother scale ( -17.9 vs -14.4 ; p=0.0086 ) and coping domain ( 15.4 vs 12.4 ; p=0.0491 ) . Acute urinary retention requiring catheterization occurred in residual volume or maximum urinary flow rate . CONCLUSIONS Men with bothersome OAB symptoms despite continued alpha-blocker therapy showed significantly greater improvements in diary variables , IPSS Storage scores , and symptom bother when receiving additional tolterodine ER versus placebo plus alpha-blocker",
"OBJECTIVE Estimate the prevalence of urinary incontinence ( UI ) , overactive bladder ( OAB ) , and other lower urinary tract symptoms ( LUTS ) among men and women in five countries using the 2002 International Continence Society ( ICS ) definitions . METHODS This population -based , cross-sectional survey was conducted between April and December 2005 in Canada , Germany , Italy , Sweden , and the United Kingdom using computer-assisted telephone interviews . A r and om sample of men and women aged > /= 18 yr residing in the five countries and who were representative of the general population s in these countries was selected . Using 2002 ICS definitions , the prevalence estimates of storage , voiding , and postmicturition LUTS were calculated . Data were stratified by country , age cohort , and gender . RESULTS A total of 19,165 individuals agreed to participate ; 64.3 % reported at least one LUTS . Nocturia was the most prevalent LUTS ( men , 48.6 % ; women , 54.5 % ) . The prevalence of storage LUTS ( men , 51.3 % ; women , 59.2 % ) was greater than that for voiding ( men , 25.7 % ; women , 19.5 % ) and postmicturition ( men , 16.9 % ; women , 14.2 % ) symptoms combined . The overall prevalence of OAB was 11.8 % ; rates were similar in men and women and increased with age . OAB was more prevalent than all types of UI combined ( 9.4 % ) . CONCLUSIONS The EPIC study is the largest population -based survey to assess prevalence rates of OAB , UI , and other LUTS in five countries . To date , this is the first study to evaluate these symptoms simultaneously using the 2002 ICS definitions . The results indicate that these symptoms are highly prevalent in the countries surveyed",
"PURPOSE We evaluate the effect of tolterodine combined with tamsulosin on quality of life in patients with bladder outlet obstruction and concomitant detrusor instability . MATERIAL S AND METHODS The study included 50 consecutive patients with urodynamically proven mild or moderate bladder outlet obstruction and concomitant detrusor instability . All patients were initially treated with 0.4 mg . tamsulosin orally once a day . A week later the patients were r and omly allocated into group 1 - 25 who continued treatment with tamsulosin only and , group 2 - 25 who also received 2 mg . tolterodine orally twice daily . Reevaluation with a quality of life question naire and urodynamic study was performed after 3 months . RESULTS Two patients from group 2 stopped tolterodine while 1 patient from each group stopped tamsulosin because of hypotension . Analysis revealed statistically significant improvement in quality of life scores only in group 2 patients ( mean score 525.0 and 628.4 before and after treatment , respectively , 2-sided t test p = 0.0003 ) . A significant difference was noted in both groups after treatment for maximum flow rate and volume at first contraction . Additionally , in group 2 , a statistically significant difference was observed for maximum detrusor pressure and maximum unstable contraction pressure after treatment . CONCLUSIONS Combination treatment with an alpha-blocker ( tamsulosin ) plus an anticholinergic ( tolterodine ) improves quality of life in patients with bladder outlet obstruction and concomitant detrusor instability . Interestingly , no acute urinary retention was observed and tolterodine did not affect the quality of urine flow or residual urine volume . The proposed combination appears to be an effective and relatively safe treatment option in patients with bladder outlet obstruction and detrusor instability",
"OBJECTIVE To compare two new generation antimuscarinics at their recommended doses for treatment of overactive bladder syndrome ( OAB ) . METHODS A prospect i ve , double blind , double-dummy , two-arm , parallel-group , 12-week study was conducted to compare the efficacy and safety of solifenacin 5 or 10 mg and tolterodine extended release ( ER ) 4 mg once daily in OAB patients . After 4 weeks of treatment patients had the option to request a dose increase but were dummied throughout as approved product labelling only allowed an increase for those on solifenacin . RESULTS Solifenacin , with a flexible dosing regimen , showed greater efficacy to tolterodine in decreasing urgency episodes , incontinence , urge incontinence and pad usage and increasing the volume voided per micturition . More solifenacin treated patients became continent and reported improvements in perception of bladder condition assessment s. The majority of side effects were mild to moderate in nature , and discontinuations were comparable and low in both groups . CONCLUSIONS Solifenacin , with a flexible dosing regimen , was found to be superior to tolterodine ER with respect to the majority of the efficacy variables",
"PURPOSE Many patients with overactive bladder discontinue pharmacotherapy due to suboptimal efficacy or side effects . Mirabegron , a β3-adrenoceptor agonist , may offer an effective and well tolerated alternative treatment for overactive bladder . MATERIAL S AND METHODS A r and omized , double-blind , placebo controlled trial was conducted in the United States and Canada . After a 2-week placebo run-in period , adults with overactive bladder symptoms for 3 or more months were r and omized 1:1:1 to receive placebo , 50 or 100 mg mirabegron once daily for 12 weeks . Efficacy data were collected via patient completed diaries and quality of life assessment s. Co- primary efficacy end points were changes from baseline to final visit in mean number of incontinence episodes per 24 hours and micturitions per 24 hours . Key secondary micturition and incontinence end points were also evaluated . Safety assessment s included treatment emergent adverse events , laboratory assessment s , vital signs , electrocardiograms and post-void residual volume . RESULTS Compared to placebo , 50 and 100 mg mirabegron groups demonstrated statistically significantly greater mean decreases ( 95 % CI ) from baseline for incontinence episodes ( -1.13 [ -1.35 , -0.91 ] , -1.47 [ -1.69 , -1.25 ] and -1.63 [ -1.86 , -1.40 ] ) and micturitions ( -1.05 [ -1.31 , -0.79 ] , -1.66 [ -1.92 , -1.40 ] and -1.75 [ -2.01 , -1.48 ] ) per 24 hours ( p both mirabegron doses vs placebo . The incidence of frequently reported treatment emergent adverse events ( hypertension , urinary tract infection , headache , nasopharyngitis ) was similar in the mirabegron and placebo groups . Dry mouth was reported for 1.5 % , 0.5 % and 2.1 % of patients in the placebo , 50 and 100 mg mirabegron groups , respectively . CONCLUSIONS Once daily mirabegron in a 50 or 100 mg dose is an effective treatment for overactive bladder symptoms with a low occurrence of side effects"
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41172350-06ff-11f0-808a-c43d1ab1c353
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Background / Aims : Treatment adherence is a major problem in numerous medical conditions , and is a particular challenge in patients with Alzheimer 's disease ( AD ) . Methods : This non- systematic review summarises the current literature on factors that affect adherence to cholinesterase inhibitors , the mainstay of AD treatment . Articles listed on PubMed and published during the last 10 years were included . Results : Intentional factors affecting adherence include patient , caregiver and prescriber beliefs about therapies and the disease itself . Unintentional factors include tolerability , physical limitations of the patient and caregiver burden . Interventions aim ing to improve adherence include educational programmes and new drug delivery methods . Conclusion : Due to the high level of caregiver involvement in the care of patients with AD , strategies that address caregiver concerns may improve adherence
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[
"Mild cognitive impairment ( MCI ) and cognitive impairment , no dementia ( CIND ) might be the optimum stage at which to intervene with preventative therapies . This article review s recent work on the possible treatment and presents evidence ‐based recommendations approved at the meeting of the Third Consensus Conference on the Diagnosis and Treatment of Dementia held in Montreal in March , 2006 . A number of promising nonpharmacologic interventions have been examined . Associations exist with both cognitive and physical activity that suggest that both of these , together or separately , can delay progression to dementia . Similarly , case control studies as well as prospect i ve long‐term studies suggest a number of low toxicity interventions and supplements that might significantly impact on MCI progression ; folate , B6 , and B12 to lower homocysteine levels , omega‐fatty acids , and anti‐oxidants ( fruit juices or red wine ) are good examples . In selected genotypes such as individuals with APOE e4 , therapy with donepezil might slow progression . The concern , however , is that none of these therapies ( including cholinesterase inhibitors ) have demonstrated a clinical ly meaningful effect with r and omized , placebo‐controlled studies . Just as r and omized controlled studies have failed to support primary prevention of dementia by using estrogen or nonsteroidal anti‐inflammatory drugs ( NSAIDs ) , there exists the possibility that well‐ design ed r and omized controlled trials might fail to definitively demonstrate putative or promising mild cognitive impairment interventions . Pharmacologic interventions and nonpharmacologic therapies , while tantalizing , are currently for the most part insufficiently proven to allow serious consideration by physicians . Recommendation were supported for a general “ healthy lifestyle ” including physical exercise , healthy nutrition , smoking cessation , and mental stimulation . Close monitoring and treatment of vascular risk factors are justified and were also supported",
"This study used performance tests to assess the cognitive , visual and physical abilities related to taking medicines in the elderly population . The study population consisted of the Swedish Panel Study of Living Conditions of the Oldest Old ( SWEOLD II ) , a nationally representative interview survey . SWEOLD II is a r and om sample of all community-based and institutionalized persons aged 77 + in Sweden . Five tests related to medication management were administered in the direct interviews ( n=492 ) : h and function ( opening bottle ) , vision ( reading label ) , and medication competence ( comprehension and calculation ) . Results showed that 9.4 % could not read instructions on a medicine container and 14.6 % had difficulty opening a plastic flip-top medicine bottle . The three cognitive tests related to taking medicine result ed in 30.7 , 47.4 and 20.1 % errors . Combining all the tests revealed that 66.3 % of the sample had at least one limitation of capacity related to taking medicine . There were no significant gender differences . Among those people who did not pass all the tests , 31.8 % lived alone with no home-help . Taking medicines is a complex task and a large proportion of the Swedish elderly population has cognitive , visual or physical limitations that may hinder their ability to take medicines accurately . Awareness of these limitations is essential to concordance",
"BACKGROUND Alzheimer 's disease is fast becoming a major public health concern with serious economic consequences . The cholinesterase inhibitors ( CEIs ) offer some benefit in the symptomatic treatment of the disease . This study aims to investigate the effect of CEIs on three clinical ly relevant domains ( rapid cognitive decline , institutionalization , and weight loss ) in patients with Alzheimer 's disease . METHODS A prospect i ve observational study was performed in which a population of 455 Alzheimer 's disease patients were recruited and followed up for at least 1 year between 1994 and 2002 . Patients were reevaluated at 6 monthly intervals using st and ardized neurocognitive and geriatric evaluations in addition to complete clinical examination , st and ard para clinical investigations , and recording of treatment received . RESULTS The risk of rapid cognitive deterioration was significantly decreased in patients taking CEIs for at least 1 year compared to untreated patients ( odds ratio [OR]=0.56 , 95 % confidence interval [ CI ] , 0.34 - 0.93 ; p=.025 ) . The potential benefit of CEI use was also found on institutionalization ( OR=0.2 , 95 % CI , 0.08 - 0.48 ; p weight loss ( OR=0.56 , 95 % CI , 0.32 - 0.97 ; p=.039 ) after 1 year of follow-up . CONCLUSION The special interest of this study is that all patients were recruited and followed in the same center with the same management care plan and the same medical team . This follow-up offers us a unique opportunity to compare the 1-year evolution of the disease in clinical practice before and after the marketing of CEIs and allows us to demonstrate a clinical ly significant improvement in patient outcome over time",
"Introduction Management of patients with Alzheimer ’s Disease ( AD ) can exert a substantial burden upon caregivers . As new modes of treatment administration are developed , it is important to assess caregiver satisfaction and preference in a st and ardized manner . This study describes the development of the Alzheimer ’s Disease Caregiver Preference Question naire ( ADCPQ ) to assess AD caregivers ’ satisfaction with and preference for patch or capsule treatments in AD patients . Methods Twenty-five published articles ( 1987 - 2002 ) were review ed to identify potential ADCPQ domains . Three caregiver focus groups ( n=24 ) were conducted to develop a first draft of the question naire . After evaluating the acceptance of ADCPQ to caregivers through in-depth interviews ( n=10 ) , its psychometric properties were assessed using data from 986 patients enrolled in a multicenter , r and omized , double-blind , four-arm , placebo- and active-controlled , 24-week trial . Results Focus groups indicated that caregivers expressed dissatisfaction with current AD treatment routines including limitations related to : efficacy , administration schedule , number of pills , adherence to treatment , side effects , and taking pills . In-depth interviews with caregivers found the ADCPQ to be comprehensible with an acceptable layout . The result ant ADCPQ comprises three modules : A ) baseline , 11 items assessing treatment expectations ; B ) week 8 , 33 items on satisfaction and preferences with treatment options ; C ) week 24 , 10 items assessing overall opinions of treatment options . Missing data per item was low ( ≤0.3 % ) and domain internal consistency reliability was good ( 0.71–0.91 ) . Preference items were also valid when evaluating concordance and discordance between convenience and satisfaction patch and capsule domain scores . Conclusion AD treatment puts a significant strain on caregivers . New modes of treatment delivery may be less burdensome to caregivers , thereby increasing satisfaction and potential treatment adherence . The ADCPQ was well accepted by AD caregivers and its domains demonstrated satisfactory psychometric properties . The ADCPQ is a useful tool to underst and caregiver preferences for patch versus oral therapies in AD",
"Alzheimer disease ( AD ) has a significant impact on caregivers . Administering and managing medications is one of their many daily tasks . More effective modes of drug administration may benefit patient and caregiver , and may improve compliance . A prospect i ve outcome of the IDEAL ( Investigation of TransDermal Exelon in ALzheimer ’s disease ) trial was to evaluate caregiver preference for rivastigmine patches compared with capsules . The 24-week , r and omized , double-blind , double-dummy , placebo- and active-controlled IDEAL trial investigated once-daily rivastigmine patches vs twice-daily capsules in moderate AD patients . Caregivers rated patch adhesion throughout . The AD Caregiver Preference Question naire ( ADCPQ ) assessed patch vs capsule from caregivers ’ perspective , based on expectations , preferences , and satisfaction with treatment . A total of 1,059 caregivers completed the ADCPQ while their respective patients were on study drug . More than 70 % of caregivers preferred the patch to capsules overall . The patch was preferred to capsules with respect to ease of use ( p ease of following the schedule ( p satisfaction overall ( p less interference with daily life ( p caregivers of AD patients preferred patches to capsules for drug delivery . Preference for the patch may indicate reduced caregiver stress , substantiated by greater satisfaction and less interference with daily life . These benefits may lead to improved compliance ",
"BACKGROUND older people experience more chronic medical conditions than younger people , take more prescription medicines and are more likely to suffer from cognitive or memory problems . Older people are more susceptible to the adverse effects of medicines , which may reduce their quality of life or lead to hospitalisation or death . OBJECTIVE this study aims to identify medicine-taking practice s amongst community-dwelling people aged > or = 75 years in New Zeal and . METHODS this study was carried out in an urban setting in Dunedin ( population 120,000 ) , New Zeal and . Interviews of a r and om sample of people from the electoral roll using a structured question naire were conducted . Subjects were community-dwelling people aged > or = 75 years taking one or more prescription medicines . From a r and om sample of 810 people extracted from the electoral roll intended to recruit 300 participants , 524 people met the study criteria and were invited to participate . People living in a rest home or hospital , not contactable by telephone , or now deceased , were excluded . Responses were analysed , medicines categorised by the Anatomical Therapeutic Chemical classification and adherence classed as high , medium and low using a modified four-item Morisky Medication Adherence Scale . Univariate and multivariate linear and logistic regression was applied to combinations of variables . RESULTS in total , 316 interviews were undertaken ; a 61 % response rate . Participants were 75 - 79 ( 35 % ) , 80 - 84 ( 40 % ) and > 85 years ( 25 % ) ; New Zeal and European/European ( 84 % ) , ' New Zeal and ers ' ( 14 % ) or Maori ( 2 % ) ; and 141 ( 45 % ) lived alone . Almost half ( 49 % ) regularly saw a specialist and a third ( 34 % ) had been admitted to hospital in the past 12 months . Participants used a median of seven prescription medicines ( range 1 - 19 ) and one non-prescription medicine ( 0 - 14 ) . The majority ( 58 % ) believed medicines are effective and had systems/routines ( 92 % ) for remembering to take them . Doses tended to be missed following a change in routine , e.g. holiday . Men were more likely to report ' trouble remembering ' than women ( odds ratio = 1.86 , 95 % confidence interval 1.10 - 3.14 ; P = 0.020 ) . Seventy-five percent of people had high or medium adherence scores and 25 % , low scores . Common problems were reading and underst and ing labels ( 9 and 4 % , respectively ) and leaflets ( 12 % , 6 % ) , and difficulty swallowing solid dose forms ( 14 % ) . Only 6 % had problems paying for their medicines . Around 17 % wanted to know more about their medicines , and some people were confused about their medicines following hospital discharge . CONCLUSION overall , community-dwelling people aged > or = 75 years in this study appeared to manage their medicines well and found them affordable . Nevertheless , there is a need to improve labelling , leaflets and education on medicines , particularly at hospital discharge",
"BACKGROUND Family caregivers comprise a critical component in the care of Alzheimer 's disease ( AD ) patients . Among their many tasks , caregivers are responsible for administering and managing medications . Effective interventions incorporate the needs of both the AD patient and the caregiver , and underst and ing treatment preferences may maximize intervention effectiveness . Transdermal patches may offer advantages over conventional oral formulations . METHODS A 24-week r and omized controlled trial compared the rivastigmine patch to the rivastigmine capsule and placebo in patients with probable AD . At baseline and Weeks 8 and 24 , the AD Caregiver Preference Question naire ( ADCPQ ) was used to evaluate caregiver expectations , preferences and satisfaction with treatment . Double-dummy treatment blinding ensured that caregiver preference for the patch or capsule was not confounded by perceptions of efficacy or tolerability . Reasons for preference were also elicited . The analytic sample included caregivers who completed the ADCPQ at Weeks 8 and /or 24 . RESULTS One thous and and fifty-nine caregivers completed the ADCPQ . More than 70 % of caregivers preferred the rivastigmine patch to the capsule . The patch was significantly preferred to the capsule with respect to ease of following the schedule and ease of use . Caregivers indicated greater satisfaction overall , greater satisfaction with administration , and less interference with daily life with the patch versus the capsule ( all p Caregivers of AD patients preferred the patch to the capsule for drug delivery . Preference for the rivastigmine patch could potentially lead to improved compliance and improved clinical benefits"
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4117238c-06ff-11f0-808a-c43d1ab1c353
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This study aims to review the obesity literature in order to assess the impact of bariatric surgery on quality of life and the between- study variation by examining the st and ardized mean magnitude of effect in change in the levels of quality of life . The following data bases EMBASE , PubMed , PsycINFO , CINAHL , the Cochrane Library and Web of Science were systematic ally search ed for studies examining change in quality of life in adults receiving bariatric surgery for obesity . Seventy-two studies were included with a total of 9,433 participants treated for obesity with bariatric surgery . The average impact of bariatric surgery on quality of life corresponded to an effect size of 0.88 ( 95 % CI : 0.80 - 0.96 ) , indicating that bariatric surgery has a significant positive influence on quality of life in general . The impact varied considerably across studies with bariatric surgery showing a significantly greater positive influence on physical quality of life compared to mental quality of life . Bariatric surgery is effective in improving quality of life , especially when looking at physical well-being . Greater focus on the psychological well-being of the person undergoing surgery for obesity may lead to a better post-surgery prognosis for more people
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"OBJECTIVE US general population norms for mail administration of the Medical Outcomes Study 36-Item Short Form Version 2 ( SF-36v2 ) were established in 1998 . This article reports SF-36v2 telephone-administered norms collected in 2005 - 2006 for adults aged 35 - 89 years . STUDY DESIGN AND SETTING The SF-36v2 was administered to 3,844 adults in the National Health Measurement Study ( NHMS ) , a r and om-digit dial telephone survey . Scale scores and physical and mental component summary ( PCS and MCS ) scores were computed . RESULTS When compared with 1998 norms ( mean=50.00 , st and ard deviation [SD]=10.00 ) , SF-36v2 scores for the 2005 - 2006 general population tended to be higher : physical functioning ( mean=50.68 , SD=14.48 ) ; role limitations due to physical health problems ( mean=49.47 , SD=14.71 ) ; bodily pain ( mean=50.66 , SD=16.28 ) ; general health perceptions ( mean=50.10 , SD=16.87 ) ; vitality ( mean=53.71 , SD=15.35 ) ; social functioning ( mean=51.37 , SD=13.93 ) ; role limitations due to emotional problems ( mean=51.44 , SD=13.93 ) ; mental health ( mean=54.27 , SD=13.28 ) ; PCS ( mean=49.22 , SD=15.13 ) ; MCS ( mean=53.78 , SD=13.14 ) . PCS and MCS factor scoring coefficients were similar to those previously reported for the 1998 norms . SF-36v2 norms for telephone administration were created . CONCLUSION The higher scores for NHMS data are likely due to the effect of telephone administration . The 2005 - 2006 norms can be used as a reference to interpret scale and component summary scores for telephone-administered surveys with the SF-36v2",
"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 We analyzed the health-related quality of life ( HRQOL ) and its determinants in the first year after laparoscopic adjustable gastric b and ing ( LAGB ) . The setting was 10 Italian public and private bariatric surgery centers . METHODS Data collected in an ongoing , prospect i ve , 3-year multicenter Italian study on the changes in HRQOL after LAGB were used . HRQOL was investigated using the Medical Outcomes Study Short-Form 36 question naire . Hunger , satiety , and the self-perceived effects of LAGB were recorded . RESULTS A total of 334 patients were enrolled . The follow-up rate was 92.2 % . The percentage of excess weight loss was 39.6 % ± 25.8 % , with very few side effects or complications . Hunger in the morning ( 0 - 10 scale ) was 4.5 ± 2.7 before surgery and 3.8 ± 2.4 after 1 year ( P .001 ) . Satiety after a meal ( 0 - 10 scale ) was 7.1 ± 2.7 before surgery and 8.2 ± 1.9 at 1 year ( P The self-perceived effect of LAGB on caloric intake ( 0 - 10 scale ) was 8.4 ± 1.9 after 1 year . The scores for the 8 Medical Outcomes Study Short-Form 36 subscales were significantly improved after surgery . The physical component summary score was 52.6 ± 11.9 at baseline and 79.1 ± 15.6 after 1 year ( P .001 ) . The corresponding mental component summary scores were 52.2 ± 12.3 and 76.5 ± 17.2 ( P improvement was independently associated with a low initial physical component summary ( P ( P = .002 ) , a high percentage of excess weight loss ( P = .013 ) , and a high self-perceived effect of the LAGB ( P = .026 ) . Greater mental component summary improvement was associated with a low initial mental component summary ( P ( P ( P = .004 ) , and a high percentage of excess weight loss ( P = .012 ) . CONCLUSIONS Significant improvements in HRQOL were observed in the first year after LAGB . A poor baseline HRQOL , a high efficacy of the b and ing in eating control , and better weight loss might influence HRQOL changes",
"Quality of life improves after bariatric surgery . However , long-term results and the influence of reoperations are not well known . A prospect i ve quality of life assessment before , 1 and 7 years after laparoscopic adjustable gastric b and ing ( LAGB ) and vertical b and ed gastroplasty ( VBG ) was performed in order to determine the influence of reoperations during follow-up . One hundred patients were included in the study . Fifty patients underwent VBG and 50 LAGB . Patients completed the quality of life question naires prior to surgery and two times during follow-up . Health-related quality of life ( HRQoL ) question naires included the Nottingham Health Profile I and II and the Sickness Impact Profile 68 . Follow-up was 84 % with a mean duration of 84 months ( 7 years ) . During follow-up , 65 % of VBG patients underwent conversion to Roux-en-Y gastric bypass while 44 % of LAGB patients underwent a reoperation or conversion . One year after the procedure , nearly all quality -of-life parameters significantly improved . After 7 years , the Nottingham Health Profile (NHP)-I domain “ physical ability ” , the NHP-II and the SIP-68 domains “ mobility control ” , “ social behavior ” , and “ mobility range ” were still significantly improved in both groups . The domains “ emotional reaction ” , “ social isolation ” ( NHP-I ) , and “ emotional stability ” ( SIP-68 ) remained significantly improved in the VBG group while this was true for the domain “ energy level ” ( NHP-I ) in the LAGB group . Both the type of procedure and reoperations during follow-up were not of significant influence on the HRQoL results . Weight loss and decrease in comorbidities were the only significant factors influencing quality of life . Restrictive bariatric surgery improves quality of life . Although results are most impressive 1 year after surgery , the improvement remains significant after long-term follow-up . Postoperative quality of life is mainly dependent on weight loss and decrease in comorbidities and not on the type of procedure or surgical complications",
"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",
"The study objectives were to assess 2-year changes in health-related quality of life ( HRQL ) after gastric bypass in patients with severe obesity and to analyze HRQL improvements in relation to weight loss after bariatric surgery . This was a prospect i ve intervention study with consecutive patients referred to two bariatric surgical units in the Basque Country . We used both generic ( Short Form Health Survey , SF-36 and EuroQol , EQ-5D ) , and specific question naires ( Moorehead-Ardelt , MA II and Obesity-related Problems Scale , OP ) . Effect sizes and receiver operating characteristic ( ROC ) curves were calculated to assess the change in quality of life . Spearman ’s correlation coefficient was calculated to assess whether there was an association between changes in body mass index ( BMI ) and HRQL . Of 82 patients who underwent surgery , 79 were followed-up for 2 years . Mean weight loss was 37 % of body weight ( 49 kg ) and BMI fell from 50.6 to 31.8 . The initial problems and final improvements were greater in the physical dimensions . Considerable benefits were observed in assessment s with all the instruments used . However , the changes in weight/ BMI and HRQL were not linear . The comparison with general population showed a similar profile in SF-36 dimensions after surgery . Severely obese patients have lower perceived health across all dimensions of quality of life . Moreover , the impact on functioning is so important that severe obesity can be described as a cause of disability that disappears 2 years after surgical treatment . ROC curves indicate that most of the HRQL measures are poor predictors of change in terms of reduction in body weight or BMI",
"Background Obesity is a risk factor for female pelvic floor disorders . The study objective was to determine whether there was a difference in the subjective reporting of pelvic symptoms before and after bariatric surgery . Methods This was a prospect i ve cohort study of female patients that underwent bariatric surgery . Patients completed a demographic question naire , the Pelvic Floor Distress Inventory-20 ( PFDI-20 ) , and the Pelvic Floor Impact Question naire-7 ( PFIQ-7 ) before surgery and at 6 and 12 months following surgery . Body mass index ( BMI ) was compared between time points using Student ’s t tests ( P Symptom and impact on quality of life prevalence were compared using McNemar ’s test and question naire scores were compared using the Wilcoxon matched pairs test ( P 63 patients had completed the study . Even with significant weight loss ( BMI , 43.7 kg/m2 to BMI , 29 kg/m2 ; P pelvic floor symptom impact on quality of life did significantly decrease after surgery ( 56 % to 30 % ; P = 0.004 ) . Baseline PFDI-20 and PFIQ-7 scores were low ; however , there was still a significant reduction in PFDI-20 and PFIQ-7 scores after surgery ( P pelvic floor symptoms did not vary greatly after surgery ; however , significant weight reduction did improve the degree of bother and quality of life related to these symptoms",
"Background The purpose of the present study is to evaluate the impact of a health psychology-led bariatric rehabilitation service ( BRS ) on patient weight loss following bariatric surgery at 1 year . Methods A single-site open-r and omised parallel group control trial based at St. Richard ’s Hospital in Chichester in the UK . Patients ( n = 162 ) were recruited immediately prior to Roux-en-Y gastric bypass and r and omly allocated to receive either treatment as usual ( n = 80 ) or the BRS ( n = 82 ) . The BRS involved three 50-min one-to-one sessions with a health psychologist and provided information , support and mentoring pre and post surgery addressing psychological issues such as dietary control , self esteem , coping and emotional eating . Weight loss was assessed at 1 year . The key outcome variable was BMI and change in BMI . Results Follow-up weight was available for 145 patients . Intention-to-treat analysis ( n = 162 ) using last measured weights showed that mean change in BMI by 1 year post surgery was −16.49 . There was no significant difference between the two groups ( control group = −16.37 , 95 % CI = 15.15–17.57 ; intervention = −16.6 , 95 % CI = 15.42–17.81 ; ηp2 = 0.001 ) . Similarly , explanatory analysis ( n = 145 ) showed a mean change in BMI of −17.17 . The difference between the two groups was not significant ( control group = −16.9 , 95 % CI = 15.78–18.18 ; intervention = −17.35 , 95 % CI = 18.5–16.16 ; ηp2 = 0.001 ) . Conclusions Psychological support pre and post bariatric surgery had no impact on weight loss as measured by BMI and change in BMI by 1 year . It is argued that psychological support should be targeted to patients who start to demonstrate weight regain at a later stage . Trial registration : Clinical Trials.gov NCT01264120",
"The study objective was to ascertain outcomes with the Swedish adjustable gastric b and ( SAGB ) on an intention-to-treat basis in multiple centers across the French social health insurance system . SAGB results at 3-year follow-up are reported . The noncomparative , observational , prospect i ve , consecutive cohort study design sought a 500-patient minimum recruitment geographically representative of continental France . Safety ( adverse events [ AEs ] , device-related morbidity , and mortality ) and effectiveness ( change in body mass index [ BMI , kilograms per square meter ] , percentage excess weight loss , comorbidities , quality of life [ QoL ] ) were assessed . Adjustable gastric b and survival was calculated . Thirty-one surgeons in 28 multidisciplinary teams/sites enrolled patients between September 2 , 2007 and April 30 , 2008 . SAGB was successfully implanted in 517 patients : 88.0 % female ; mean age , 37.5 years ; obesity duration , 15.3 years ( baseline : mean BMI , 41.0 ; comorbidities , 773 in 74.3 % of patients ; Bariatric Analysis and Reporting Outcome System ( BAROS ) , 1.4 ; EuroQoL 5-Dimensions ( EQ-5D ) , 0.61 ; EuroQoL – visual analog scale ( EQ – VAS ) , 52.3 ) . At 3 years : BMI , 32.2 ( mean change , −9.0 ; p excess weight loss , 47.4 % ; comorbidities , 161 in 27.2 % ; BAROS , 3.6 ( + 2.2 , p ) ; EQ – VAS , 73.4 ( + 21.4 , p ) . SAGB-induced weight loss was associated with substantially improved QoL. One death occurred and was unrelated to the treatment . No AE was reported in 68.3 % of patients , and no confirmed device-related AE in 77.0 % . Overall AE rate was 0.19 per patient year . Device retention was 87.0 % . Analysis of patients lost to follow-up showed a nonsignificant effect on overall study results . In a prospect i ve , consecutive cohort , “ real-world ” , nationwide study , the Swedish Adjustable Gastric B and was found safe and effective at 3-year follow-up",
"Background Bariatric surgery is currently the most effective form of obesity management for those whose BMI is greater than 40 ( or 35 with co morbidities ) . A minority of patients , however , either do not show the desired loss of excess weight or show weight regain by follow up . Research highlights some of the reasons for this variability , most of which centres on the absence of any psychological support with patients describing how although surgery fixes their body , psychological issues relating to dietary control , self esteem , coping and emotional eating remain neglected . The present study aims to evaluate the impact of a health psychology led bariatric rehabilitation service ( BRS ) on patient health outcomes . The bariatric rehabilitation service will provide information , support and mentoring pre and post surgery and will address psychological issues such as dietary control , self esteem , coping and emotional eating . The package reflects the rehabilitation services now common place for patients post heart attack and stroke which have been shown to improve patient health outcomes . Methods / Design The study is a r and omised control trial and patients will be allocated to receive either usual care or the bariatric rehabilitation service pre and post bariatric surgery . Follow up measures of weight loss and psychological issues will be taken at baseline ( 2 weeks preoperatively ) , 3 , 6 and 12 months postoperatively . The contents of the bariatric service and the follow up measures are based on previous pilot work and have been developed further by the research team working closely with two patient support groups ( BOSPA & WLSinfo ) . This study will take place in St Richard 's Hospital in Chichester in the UK . Discussion It is predicted that a bariatric rehabilitation service will improve weight loss following surgery and will also facilitate changes in other psychological variables such as quality of life , dietary control , self esteem , coping and emotional eating . This also has cost implication s for the NHS and other healthcare providers as improved effectiveness of bariatric surgery reduces the health costs of obese patients in the longer term . Trial registration Clinical Trials.gov NCT01264120",
"Background There is little robust evidence relating to changes in health related quality of life ( HRQL ) in morbidly obese patients following a multidisciplinary non-surgical weight loss program or laparoscopic Roux-en-Y Gastric Bypass ( RYGB ) . The aim of the present study was to describe and compare changes in five dimensions of HRQL in morbidly obese subjects . In addition , we wanted to assess the clinical relevance of the changes in HRQL between and within these two groups after one year . We hypothesized that RYGB would be associated with larger improvements in HRQL than a part residential intensive lifestyle-intervention program ( ILI ) with morbidly obese subjects . Methods A total of 139 morbidly obese patients chose treatment with RYGB ( n=76 ) or ILI ( n=63 ) . The ILI comprised four stays ( seven weeks ) at a specialized rehabilitation center over one year . The daily schedule was divided between physical activity , psychosocially-oriented interventions , and motivational approaches . No special diet or weight-loss drugs were prescribed . The participants completed three HRQL- question naires before treatment and 1 year thereafter . Both linear regression and ANCOVA were used to analyze differences between weight loss and treatment for five dimensions of HRQL ( physical , mental , emotional , symptoms and symptom distress ) controlling for baseline HRQL , age , age of onset of obesity , BMI , and physical activity . Clinical relevance was assessed by effect size ( ES ) where ES.80 as large . Results The adjusted between group mean difference ( 95 % CI ) was 8.6 ( 4.6,12.6 ) points ( ES=.83 ) for the physical dimension , 5.4 ( 1.5–9.3 ) points ( ES=.50 ) for the mental dimension , 25.2 ( 15.0–35.4 ) points ( ES=1.06 ) for the emotional dimension , 8.7 ( 1.8–15.4 ) points ( ES=.37 ) for the measured symptom distress , and 2.5 for ( .6,4.5 ) fewer symptoms ( ES=.56 ) , all in favor of RYGB . Within-group changes in HRQOL in the RYGB group were large for all dimensions of HRQL . Within the ILI group , changes in the emotional dimension , symptom reduction and symptom distress were moderate . Linear regression analyses of weight loss on HRQL change showed a st and ardized beta-coefficient of –.430 ( p the physical dimension , –.288 ( p=.004 ) on the mental dimension , –.432 ( p the emotional dimension , .287 ( p=.008 ) on number of symptoms , and .274 ( p=.009 ) on reduction of symptom pressure . Conclusions Morbidly obese participants undergoing RYGB and ILI had improved HRQL after 1 year . The weaker response of ILI on HRQL , compared to RYGB , may be explained by the difference in weight loss following the two treatments . Trial registration Clinical Trials.gov number",
"BACKGROUND Gastric restrictive surgery induces a marked change in eating behavior . However , the relationship between preoperative and postoperative eating behavior and weight loss outcome has received limited attention . OBJECTIVE This study assessed a range of eating behaviors before and 1 year after laparoscopic adjustable gastric b and ing ( LAGB ) and explored the nature and extent of change in eating patterns , their clinical associates , and impact on weight loss . METHODS AND PROCEDURES A 12-month observational study assessed presurgical and postsurgical binge eating disorder ( BED ) , uncontrolled eating , night eating syndrome ( NES ) , grazing , nutrient intake and eating-related behaviors , and markers of psychological distress . A total of 129 subjects ( 26 male and 103 female , mean age 45.2 + /- 11.5 and BMI 44.3 + /- 6.8 ) participated in this study . RESULTS Presurgical BED , uncontrolled eating , and NES occurred in 14 % , 31 % , and 17.1 % of subjects , which reduced after surgery to 3.1 % , 22.5 % , and 7.8 % , respectively ( P = 0.05 for all ) . Grazing was prevalent before ( 26.3 % ) and after surgery ( 38.0 % ) . Preoperative BED most frequently became grazers ( P = 0.029 ) . The average percentage weight loss ( % WL ) was 20.8 + /- 8.5 % ; range -0.67 to 50.0 % and percentage of excess weight loss ( % EWL ) 50.0 + /- 20.7 % ; range -1.44 to 106.9 % ( P Uncontrolled eating and grazing after surgery showed high overlap and were associated with poorer % WL ( P = 0.008 and P distress . DISCUSSION Consistent with recent studies , uncontrolled eating and grazing were identified as two high-risk eating patterns after surgery . Clearer characterization of favorable and unfavorable postsurgical eating behaviors , reliable methods to assess their presence , and empirically tested postsurgical intervention strategies are required to optimize weight loss outcomes and facilitate psychological well-being in at-risk groups",
"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",
"OBJECTIVE : To examine the effects of weight loss on health-related quality of life ( HRQL ) in subjects with severe obesity . DESIGN : Controlled clinical trial of the outcomes of surgical vs conventional weight reduction treatment . SUBJECTS : The first 487 surgical cases and their conventionally treated , matched controls were followed for two years in the Swedish Obese Subjects ( SOS ) intervention study . MEASUREMENTS : A battery of generic and study -specific self- assessment instruments or subscales was used to characterize HRQL in the severely obese ( BMI ) ≥34 kg/m2 for males and BMI ≥38 kg/m2 for females ) . Measures of general health perceptions ( general health rating index ; current health ) , mental well-being ( mood adjective check list ; pleasantness , activation and calmness ) , mood disorders ( hospital anxiety and depression scale ; anxiety and depression ) and social interaction ( sickness impact profile ) , were supplemented by obesity-specific modules on obesity-related psychosocial problems and eating behavior ( three-factor eating question naire ; restrained eating , disinhibition and perceived hunger ) . Assessment s were conducted prior to treatment and repeated after 6 , 12 and 24 months . RESULTS : Poor HRQL before intervention was dramatically improved after gastric restriction surgery , while only minor fluctuations in HRQL scores were observed in the conventionally treated controls . Peak values were observed in the surgical group at 6 or 12 months after intervention with a slight to moderate decrease at the two-year follow-up . The positive changes in HRQL after two years were related to the magnitude of weight loss , that is , the greater the weight reduction , the greater the HRQL improvements . Eating behavior improved accordingly . CONCLUSION : Quality of life in the severely obese is improved by substantial weight loss . Most patients benefit from weight reduction surgery , while HRQL in surgical patients with minor reduction in overweight is less positive . Further research is needed to determine outcome predictors of the surgical management of severe obesity and to ensure that HRQL improvements are maintained",
"To evaluate influence of laparoscopic gastric b and ing ( LGB ) on quality of life ( QOL ) in patients with morbid obesity . Laparoscopic adjustable gastric b and ing is a popular bariatric operation in Europe . The objectives of surgical therapy in patients with morbid obesity are reduction of body weight , and a positive influence on the obesity-related comorbidity as well the concomitant psychologic and social restrictions of these patients . In a prospect i ve clinical trial , development of the individual patient QOL was analyzed , after LGB in patients with morbid obesity . From October 1999 to January 2001 , 152 patients [ 119 women , 33 men , mean age 38.4 y ( range 24 to 62 ) , mean body mass index 44.3 ( range 38 to 63 ) ] underwent evaluation for LGB according the following protocol : history of obesity ; concise counseling of patients and relative on nonsurgical treatment alternatives , risk of surgery , psychologic testing , question naire for eating habits , necessity of lifestyle change after surgery ; medical evaluation including endocrinologic and nutritionist work-up , upper GI endoscopy , evaluation of QOL using the Gastro Intestinal Quality of Life Index ( GIQLI ) . Decision for surgery was a multidisciplinay consensus . This group was follow-up at least 2 years , focusing on weight loss and QOL . Mean operative time was 82 minutes ; mean hospital stay was 2.3 days and the mean follow-up period was 34 months . The BMI dropped from 44.3 to 29.6 kg/m2 and all comorbid conditions improved markedly : diabetes melitus resolved in 71 % of the patients , hypertension in 33 % , and sleep apnea in 90 % . However , 26 patients ( 17 % ) had late complications requiring reoperation . Preoperative global GIQLI score was 95 ( range 56 to 140 ) , significant different of the healthy volonteers score ( 120 ) ( 70 to 140 ) P weight loss ( percentage loss of overweight and BMI ) , the global score of the group increased to 100 at 3 months , 104 at 6 , 111 at 1 year to reach 119 at 2 years which is no significant different of healthy patients . Analyzing the subscale , physical condition , emotional status , and social integration increased significantly ( P global Giqli score is not modified . Patients who have required successfull revisional surgery for late complications ( 6.5 % ) have an excellent QOL outcome that are not different from the whole group . Together with a satisfactory reduction of the excess overweight , laparoscopic gastric b and ing may lead in a carefully selected population of patients with morbid obesity to a significant improvment of patient QOL , in at least 2 years follow-up",
"Background Laparoscopic sleeve gastrectomy ( LSG ) is a promising procedure for the surgical treatment of morbid obesity . We report our 2-year experience with LSG and specifically evaluate the importance of staple-line protection to prevent leakage after the laparoscopic procedure . Methods One hundred eighteen consecutive patients with BMI > 30 who underwent LSG from January 2006 to February 2009 were included in our study . There were 88 women and 30 men with a mean age of 33.2 ± 9.6 years and a mean BMI of 38.0 ± 6.4 kg/m2 . The first 40 patients ( group 1 ) underwent the operation without any reinforcement procedure and the other 78 patients received reinforcement of the staple-line ( group 2 ) . Data including demographics , hospital stay , blood loss , operative time , complications , excess weight loss percentage ( EWL% ) , and gastrointestinal quality of life index ( GIQLI ) were collected prospect ively for evaluation . Results The overall mean operative time was 118.5 ± 37.0 min , mean blood loss was 56.8 ± 56.7 ml , mean hospital stay was 5 ± 3 days . The mean EWL% at 12 and 24 months was 81.5 and 76.0 % , respectively . The overall leakage rate was 3.39 % ( 4/118 ) . All leakage occurred in group 1 patients , with a leakage rate of 10 % ( 4/40 ) . Mean preoperative GIQLI was 98.7 , and the postoperative GIQLI were 116.4 , 115 , 112.4 , and 97.6 at 3 , 6 , 12 , and 24 months , respectively . Conclusions LSG is an effective obesity treatment to achieve significant weight loss after 24 months . Staple-line reinforcement is strongly recommended for laparoscopic sleeve gastrectomy to decrease complications",
"Objectives : This prospect i ve , r and omized trial compared the safety and effectiveness of laparoscopic Roux-en-Y gastric bypass ( LRYGBP ) and laparoscopic mini-gastric bypass ( LMGBP ) in the treatment of morbid obesity . Summary Background Data : LRYGBP has been the gold st and ard for the treatment of morbid obesity . While LMGBP has been reported to be a simple and effective treatment , data from a r and omized trial are lacking . Methods : Eighty patients who met the NIH criteria were recruited and r and omized to receive either LRYGBP ( n = 40 ) or LMGBP ( n = 40 ) . The minimum postoperative follow-up was 2 years ( mean , 31.3 months ) . Perioperative data were assessed . Late complication , excess weight loss , BMI , quality of life , and comorbidities were determined . Changes in quality of life were assessed using the Gastro-Intestinal Quality of Life Index ( GIQLI ) . Results : There was one conversion ( 2.5 % ) in the LRYGBP group . Operation time was shorter in LMGBP group ( 205 versus 148 , P no mortality in each group . The operative morbidity rate was higher in the LRYGBP group ( 20 % versus 7.5 % , P late complications rate was the same in the 2 groups ( 7.5 % ) with no reoperation . The percentage of excess weight loss was 58.7 % and 60.0 % at 1 and 2 years , respectively , in the LPYGBP group , and 64.9 % and 64.4 % in the LMGBP group . The residual excess weight LMGBP group ( P obesity-related clinical parameters and complete resolution of metabolic syndrome in both groups were noted . Both gastrointestinal quality of life increased significantly without any significant difference between the groups . Conclusion : Both LRYGBP and LMGBP are effective for morbid obesity with similar results for resolution of metabolic syndrome and improvement of quality of life . LMGBP is a simpler and safer procedure that has no disadvantage compared with LRYGBP at 2 years of follow-up",
"Background : Laparoscopic vertical b and ed gastroplasty ( LVBG ) is a safe and effective treatment for morbid obesity . Previous studies disclosed a significant improvement in the health-related quality of life after substantial weight loss following VBG . Data regarding the specific gastrointestinal quality of life following LVBG is lacking . Material s and Methods : 223 patients who underwent LVBG for morbid obesity were studied prospect ively . Quality of life was measured by the Gastrointestinal Quality of life Index ( GIQLI ) , a 36- item question naire before surgery , and at 6 months , 1 year and 2 years after surgery . The question naire is divided into 5 domains , and the maximum score is 144 . Results : After LVBG , weight loss has been good . Mean BMI decreased from 43.2 to 31.3 after 2 years . Co-morbidities were eliminated in 71 % . 84.3 % of patients were satisfied with the results . However , the score of GIQLI remained similar before and after surgery . Preoperative score was 106.2±19 points . The score became 116.6±9 , 106.8±21 , and 108.5±20 at 6 months , 1 year and 2 years after surgery respectively . The patients had improvement in 3 domains of the question naire ( social function , physical status and psychological emotions ) but decreased in domains of core symptoms and disease-specific items . Conclusion : Although LVBG was effective in reduction of weight and resolution of co-morbidities in morbidly obese patients , the specific gastrointestinal quality of life did not improve . Many patients developed some specific gastrointestinal symptoms in order to obtain weight reduction",
"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",
"Background : Laparoscopic adjustable gastric b and ing ( LAGB ) is a safe and effective method for the treatment of obesity . The most common problem after LAGB has been the occurrence of prolapse ( slippage ) of the stomach through the b and . It has been proposed that the pars flaccida ( PF ) pathway ( dissection from the base of the right crus , along the left crus to the angle of His ) is less likely to be associated with prolapse than the traditional perigastric ( PG ) pathway ( dissection between the lesser curvature of stomach and lesser omentum , across the apex of the lesser sac , to the angle of His ) . We have tested this hypothesis using a r and omized controlled trial format . Methods : We have performed a r and omized controlled trial to compare the outcomes after LAGB using PF and PG pathways . 202 patients ( mean age 40 years , mean weight 123 kg , mean BMI 45 ) were r and omly allocated to the PF or PG pathway and followed for 2 years . Results : At 24 months , there have been 16 revisional procedures for prolapse , 4 in the PF group ( all anterior prolapse ) and 15 in the PG group ( 12 posterior and 3 anterior ) . This difference is significant ( P mean % excess weight lost was 53 % for the PF group and 46 % for the PG group . There was equally significant improvements in the metabolic syndrome in both groups ( 59 % preoperatively and 19 % at 2 years ) . All 8 paired domain scores of the SF-36 measures of quality of life were improved significantly in both group ( P substantial weight loss , improved health and improved quality of life and is significantly less likely to be associated with prolapse ( slippage ) . It is recommended as the primary dissection pathway",
"OBJECTIVE : To examine changes in the prevalence and severity of urinary incontinence ( UI ) and fecal incontinence in morbidly obese women undergoing laparoscopic weight loss surgery . METHODS : In a prospect i ve cohort study , 101 women ( aged 20–55 years ) with body mass index ( BMI ) of 40 or more underwent laparoscopic Roux-en-Y gastric bypass and were followed to 6 and 12 months . Presence , severity , and effect of UI were assessed using the Medical , Epidemiological , and Social Aspects of Aging Question naire , Urogenital Distress Inventory , and Incontinence Impact Question naire . Fecal incontinence was assessed by self-report of anal leakage . RESULTS : Mean BMI decreased from 48.9±7.2 presurgery to 35.3±6.5 at 6 months and 30.2±5.7 at 12 months postsurgery . Prevalence of UI decreased from 66.7 % presurgery to 41.0 % at 6 months and 37.0 % at 12 months ( P ) . Reduction in prevalence of UI was significantly associated with decreases in BMI ( P=.01 ) . Among incontinent women who lost 18 or more BMI points , 71 % regained urinary continence at 12 months . Medical , Epidemiological , and Social Aspects of Aging Question naire urge and stress scores decreased ( both P did scores on the Urogenital Distress Inventory ( P Incontinence Impact Question naire ( P . Prevalence of fecal incontinence ( solid or liquid stool ) decreased from 19.4 % to 9.1 % at 6 months and 8.6 % at 12 months ( P=.018 ; 95 % CI 2.1–19.4 % ) . CONCLUSION : Prevalence of UI and fecal incontinence decreased after bariatric surgery . Magnitude of weight loss was associated with reduction in UI prevalence , strengthening the inference that improvements are attributable to weight loss . LEVEL OF EVIDENCE :",
"Background : Vertical b and ed gastroplasty ( VBG ) and gastric bypass ( GBP ) are the two bariatric procedures recommended by NIH consensus conference . Recent advancement in laparoscopic ( L ) techniques has made LVBG and LGBP alternatives for the conventional open approach . Methods : From December 2000 to February 2002 , 80 patients ( 24 men and 56 women ; mean age 32 years , range 18 - 57 ) with morbid obesity ( mean BMI 43.2 kg/m2 , range 36 - 59.8 ) were enrolled in a prospect i ve trial and r and omly assigned to LVBG or LGBP . Changes in quality of life were assessed using the Gastro-intestinal quality of life index ( GIQLI ) . Results : The conversion rate was zero for LVBG and 2.5 % ( 1/40 ) for LGBP . There has been no mortality . Surgical time was significantly longer for LGBP ( 209 minvs 126 min for LVBG , P hospital stay was 3.5 days for the LVBG vs 5.7 days for LGBP ( P Postoperative analgesic usage was also less for LVBG patients ( mean dose 1.4 vs 2.4 , P Early complication rate was higher in the LGBP group ( 17.8 % vs 2.5 % , P anastomotic leakage ( 5 % ) . Late complications consisted of upper GI bleeding , stenosis and others observed in 4 LGBP patients ( 10 % ) and 2 LVBG patients ( 5 % ) . Mean follow-up was 20 months ( range 18 to 30 ) . BMI fell significantly in both groups , with significant improvement of obesity-related co-morbidities . LGBP had significantly better excess weight loss than LVBG ( 62.9 % vs 55.4 % at 1 year and 71.4 % vs 53.1 % at 2 years ) , as well as lower BMI than LVBG ( 29.6 vs 31.1 at 1 year and 28.5 vs 31.9 at 2 years ) . There was no difference in the reduction of obesity-related laboratory abnormalities at 1 year except a lower hemoglobin in LGBP ( 11.8 vs 13.8 , P Preoperative GIQLI scores were similar between the groups ; however , at 1 year , LGBP patients had better GIOLI scores than LVBG patients ( 121 vs 106 , P LVBG had improvement in physical condition , social function and emotional conditioning but deterioration in GI symptoms which result ed in no increase in total GIQLI score . Conclusion : LGBP was a time-consuming dem and ing technique with a higher early complication rate compared with LVBG . Although both operations result ed in significant weight reduction and decrease in obesity-related co-morbidities , LGBP had a trend of greater weight loss and significantly better GIQLI than LVBG at the cost of a significant long-term trace element deficiency state . Each patient should be individualized for the operations according to the patient 's decision",
"Background Gastric b and ing remains a common procedure worldwide . Improving health-related quality of life ( HRQOL ) has become a major goal in the treatment of patients with chronic diseases , yet there are few comprehensive data regarding the effect of gastric b and ing on HRQOL . The aim of this study was to evaluate the impact of laparoscopic gastric b and ing on HRQOL with particular regard to change over time . Methods The 262 consecutive patients included between May 2005 and September 2006 in a French multicenter prospect i ve study design ed to assess the safety and efficacy of a gastric b and were asked to complete the SF36 question naire preoperatively and each 6 months during 3 years . The HRQOL scores were compared with community norms , and their longitudinal change was assessed using cross-sectional analysis and mixed-effects linear modeling ( individual growth model ) . Results One hundred sixty-four patients ( 63 % ) provided a preoperative and at least one postoperative SF-36 question naire from 12 to 36 months and form the basis of the present study . In all dimensions , the scores of HRQOL were significantly impaired preoperatively and were significantly improved at 3 years . The increase in HRQOL scores was most marked during the first postoperative months ; it continued more slowly after 6 months and stabilized after 1 year . The improvement in HRQOL was associated with the decrease in BMI , in all dimensions . Conclusion Gastric b and ing results in a significant improvement in HRQOL . A return to normal can be expected at 1 year and persists at 3 years . The postoperative improvement in HRQOL is strongly related to weight loss",
"The intragastric balloon is a temporary treatment for obese patients . Fluid-filled devices have shown efficacy and safety , and are widely used . Recently , although there are no comparative studies between them , an air-filled balloon , Heliosphere ® bag , has been proposed . Prospect i ve , double-blind study in 33 patients with morbid and type 2 obesity : 23 female , 43.9 ± 10 years , 120.3 ± 17 kg , and body mass index ( BMI ) of 44.2 ± 5 kg/m2 , placing 18 gastric balloons filled with 960 cm3 of air ( Heliosphere ® bag ) or 15 balloons filled with 700 ml of saline ( Bioenterics-BIB ® ) . Both balloons were placed with conscious sedation and removed under general anesthesia 6 months later . Intravenous drugs were given to control symptoms for 48 h. Patients were sent home on a 1000-kcal diet , multivitamin supplements , and oral proton pump inhibitors , and were followed monthly . Complications , symptoms , weight , and quality of life evaluated by the Gastrointestinal Quality of Life Index ( GIQLI ) scale were recorded . At 6 months , mean weight loss ( 12.8 ± 8 vs 14.1 ± 8 kg ) , BMI loss ( 4.6 ± 3 vs 5.5 ± 3 kg/m2 ) and percent excess weight loss ( 27 ± 16 vs.30.2 ± 17 ) showed no significant differences between both groups . At removal , two Heliosphere ® bags were not found in the stomach , and four patients required extraction of the balloon by rigid esophagoscopy or surgery ( p = 0.02 ) . Tolerance was good in both groups , but early removal occurred in three BIB ® ( 20 % ) due to vomits and dehydration . The GIQLI total scores remained unchanged . Both balloons achieve a significant weight loss with good tolerance in obese patients . Nevertheless , Heliosphere ® bag has severe technical problems that need to be solved before recommending it",
"CONTEXT Extreme obesity is associated with health and cardiovascular disease risks . Although gastric bypass surgery induces rapid weight loss and ameliorates many of these risks in the short term , long-term outcomes are uncertain . OBJECTIVE To examine the association of Roux-en-Y gastric bypass ( RYGB ) surgery with weight loss , diabetes mellitus , and other health risks 6 years after surgery . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve Utah-based study conducted between July 2000 and June 2011 of 1156 severely obese ( body mass index [ BMI ] ≥ 35 ) participants aged 18 to 72 years ( 82 % women ; mean BMI , 45.9 ; 95 % CI , 31.2 - 60.6 ) who sought and received RYGB surgery ( n = 418 ) , sought but did not have surgery ( n = 417 ; control group 1 ) , or who were r and omly selected from a population -based sample not seeking weight loss surgery ( n = 321 ; control group 2 ) . MAIN OUTCOME MEASURES Weight loss , diabetes , hypertension , dyslipidemia , and health-related quality of life were compared between participants having RYGB surgery and control participants using propensity score adjustment . RESULTS Six years after surgery , patients who received RYGB surgery ( with 92.6 % follow-up ) lost 27.7 % ( 95 % CI , 26.6%-28.9 % ) of their initial body weight compared with 0.2 % ( 95 % CI , -1.1 % to 1.4 % ) gain in control group 1 and 0 % ( 95 % CI , -1.2 % to 1.2 % ) in control group 2 . Weight loss maintenance was superior in patients who received RYGB surgery , with 94 % ( 95 % CI , 92%-96 % ) and 76 % ( 95 % CI , 72%-81 % ) of patients receiving RYGB surgery maintaining at least 20 % weight loss 2 and 6 years after surgery , respectively . Diabetes remission rates 6 years after surgery were 62 % ( 95 % CI , 49%-75 % ) in the RYGB surgery group , 8 % ( 95 % CI , 0%-16 % ) in control group 1 , and 6 % ( 95 % CI , 0%-13 % ) in control group 2 , with remission odds ratios ( ORs ) of 16.5 ( 95 % CI , 4.7 - 57.6 ; P incidence of diabetes throughout the course of the study was reduced after RYGB surgery ( 2 % ; 95 % CI , 0%-4 % ; vs 17 % ; 95 % CI , 10%-24 % ; OR , 0.11 ; 95 % CI , 0.04 - 0.34 compared with control group 1 and 15 % ; 95 % CI , 9%-21 % ; OR , 0.21 ; 95 % CI , 0.06 - 0.67 compared with control group 2 ; both P bariatric surgery-related hospitalizations were 33 ( 7.9 % ) , 13 ( 3.9 % ) , and 6 ( 2.0 % ) for the RYGB surgery group and 2 control groups , respectively . CONCLUSION Among severely obese patients , compared with nonsurgical control patients , the use of RYGB surgery was associated with higher rates of diabetes remission and lower risk of cardiovascular and other health outcomes over 6 years",
"Few studies have investigated changes in health-related quality of life ( HRQOL ) in surgical patients who have undergone a laparoscopic sleeve gastrectomy . Prospect i ve data were obtained from 78 consecutive patients undergoing laparoscopic sleeve gastrectomy ( LSG ; mean age , 42.4 years ; mean body weight , 131 kg ; mean body mass index ( BMI ) , 47 kg/m2 ( 24.4 % of superobese patients ) ) . Two HRQOL question naires were administered preoperatively and 12 months postsurgery : the generic Medical Outcomes Study Short Form-36 and the weight-specific IWQOL-Lite question naire . Excess weight loss at 12 months was 57.18 % . No mortality was recorded . HRQOL scores revealed a significant improvement in all areas of both question naires . However , changes in HRQOL were not associated consistently with amount of weight loss . Laparoscopic sleeve gastrectomy is an effective and safe procedure , with positive changes in health-related quality of life as well as weight reduction . A fruitful area for future research is the investigation of long-term changes in HRQOL after LSG",
"In a prospect i ve study of 188 patients with morbid obesity , the time-dependent changes in the quality of life of individual patients were analyzed following laparoscopic gastric b and ing ( LGB ) . These 188 patients ( 148 females and 40 males ; age 19 to 59 years ; body mass index 33 to 72 kg/m(2 ) ) underwent evaluation of the LGB according to a strict protocol that included psychological testing using st and ardized instruments , detailed medical evaluation , upper gastrointestinal function studies , and evaluation of quality of life using the Gastrointestinal Quality of Life Index ( GIQLI ) . Following this evaluation , 73 patients ( 57 females and 16 males ; age 37 years [ range 19 to 59 years ] ; body mass index 48 kg/m(2 ) [ range 37 to 72 kg/m(2 ) ] ) underwent LGB and were followed up for 2 years focusing on weight loss , postoperative morbidity , weight-related comorbidity , and quality of life . The results demonstrate that LGB is well able to allow for a significant loss of excess weight and a significant improvement in patients ' quality of life , both after a rather short period of time after surgery and at a continuous rate throughout the follow-up . The price for this success that was found in approximately 90 % of patients is a complication rate of 38 % ; 85 % of these patients , almost one third of all patients , must undergo some type of revision surgery . However , once the complications are resolved , these patients achieve the same level of weight loss and improvement in quality of life as patients with an uncomplicated postoperative course",
"Morbid obesity is associated with excessive daytime sleepiness and reduced health-related quality of life . We prospect ively evaluated the pre- and postoperative responses of bariatric surgery recipients with the Epworth Sleepiness Scale ( ESS ) and the Short Form-12 . Participants ( n = 223 ; 79 % women ) with a mean body mass index ( BMI ) and ESS of 44.8 ± 7.9 kg/m2 and 7.9 ± 4.5 , respectively , received a vertical gastrectomy ( 76 % ) or Roux-en-Y gastric bypass ( 12 % ) . Preoperatively , 30 % of patients complained of excessive daytime sleepiness ( ESS > 10 ) . Patients with preoperative excessive daytime sleepiness were more obese ( p = 0.002 ) , had higher fasting glucose levels ( p = 0.02 ) , more likely to have a diagnosis of sleep-disordered breathing ( p report snoring ( p lower health-related quality of life measures particularly physical function ( p ) , depression ( p = 0.006 ) , and sexual satisfaction ( p = 0.04 ) than non-sleepy patients . At 12-months postoperatively , most patients experienced a significant reduction in BMI ( 28.6 ± 5.5 kg/m2 , p ) and excessive daytime sleepiness ( mean ESS 5.3 ± 3.3 , p the ESS at 12-months post-operatively had greater improvements in physical function ( p = 0.009 ) and snoring ( p = 0.010 ) and were more likely still using positive airway pressure therapy ( p = 0.032 ) than patients without a clinical ly relevant improvement . Statistically and clinical ly significant improvements in all health-related quality of life measures were noted at 24 months . Bariatric surgery is associated with dramatic weight loss and improvements in physical functioning and daytime sleepiness ",
"Bariatric surgery ameliorates obesity‐associated diseases , result ing in psychological and social benefits . Long‐term studies of its effects on quality of life ( QOL ) assessed with well established instruments are lacking . This prospect i ve study investigated the long‐term effects of gastric b and ing on health‐related QOL using an obesity‐specific vali date d measure",
"Background : Laparoscopic adjustable gastric b and ing ( LAGB ) is a safe and effective treatment for morbid obesity . Previous studies in Western countries disclosed a significant improvement in co-morbidities and health-related quality of life . Data from Asia and regarding the specific GI quality of life following LAGB are lacking . Methods : From May 2002 to May 2005 , 107 consecutive patients – 48 men and 59 women , with mean age 31.4 years ( range 17 - 57 years ) with morbid obesity ( mean weight 115.8 kg , range 81 - 174 kg ; mean BMI 41.3 kg/m2 , range 32.0 - 59.8 kg/m2 ) underwent LAGB in a prospect i ve trial . All b and s were placed via the pars flaccida technique . Quality of life was measured by the Gastrointestinal Quality of Life Index ( GIQLI ) , a 36item question naire before LAGB , and at 3 , 6 , 12 and 24 months after surgery . Results : All procedures were performed laparoscopically with no conversions . There was neither intra-operative complications nor major postoperative complications . Minor complications occurred in 3 patients ( 2.8 % ) ; all were transient stoma obstruction . At follow-up , only one b and ( 0.94 % ) was removed at 3 months postoperatively because of the patient 's intolerance . No gastric slippage occurred . 4 patients ( 3.7 % ) had tubing problems and required revision surgery for port adjustment . Mean BMI decreased from 41.3 to 33.1 after 2 years . Percent excess BMI loss averaged 48.1 % at 2 years ( range 6.7 - 139.2 ) . All co-morbidities were eliminated significantly . 80 % of patients were satisfied with the results at 2 years . However , the GIQLI score remained similar before and after surgery . Preoperative score was 110.8 + 15 points . The score became 116.2 + 13 , 114.7 + 13 , 108.5 + 14 and 107.2 + 17 at 3 , 6 , 12 and 24 months . The patients had improvement in 3 domains of general health ( social , physical and emotional functions ) , but decrease in the domain of symptoms . Conclusion : Although LAGB was successful in weight loss and resolution of co-morbidities in morbidly obese patients , the GIQLI did not improve . This feature will be the major disadvantage of LAGB",
"BACKGROUND Morbid obesity results in multiple comorbidities and an increased mortality rate . The National Institutes of Health has stated that surgery is the most effective long-term therapy ; therefore , we evaluated a laparoscopically implantable adjustable gastric b and . METHODS We review ed 2 multicenter prospect i ve , open-label , single-arm surgical trials -- trial A ( 3 years ) and trial B ( 1 year)--with ongoing safety follow-up . These trials were conducted in United States community and university hospitals ( trial A = 8 sites and trial B = 12 sites ) . Trial A comprised 292 subjects ( mean + /- SD preoperative weight : 133 kg + /- 24.4 ) , and trial B comprised 193 subjects ( 129 kg + /- 20.8 ) . Intervention included placement of a constrictive , adjustable b and around the upper stomach to limit food intake and induce weight loss . Main outcome measures were the primary efficacy end point of weight loss . Secondary end-points were change in quality -of-life , safety parameters , and complications , including b and slippage , reoperation , and device explantation . RESULTS In the 2 trials , 485 devices were implanted ( 92 % laparoscopically ) , and no deaths occurred . Of the patients in trial A , 206 ( 70.5 % ) completed the 3-year follow-up , and 142 ( 73.6 % ) of patients in trial B completed the 1-year follow-up . Weight-loss results , using the last value carried forward , for all 292 patients in trial A and all 193 patients in trial B demonstrated a change in mean body mass index ( kg/m2 ) + /- SD from 47.4 + /- 7.0 to 39.0 + /- 7.3 in trial A and from 46.7 + /- 7.8 to 38.4 + /- 7.6 in trial B subjects at 1 year ( P percentage of initial body weight lost at 1 year was 17.7 % + /- 9.4 % for trial A subjects and 18.2 % + /- 8.9 % for trial B subjects , whereas the 3-year total for trial A subjects was 18.3 % + /- 13.1 % . At 1 year , 76 % of patients in trial A and 66 % of patients in trial B had complications , mostly related to upper gastrointestinal symptoms . By 9 years after surgery , 33 % ( 96 of 292 ) of trial A subjects had their devices explanted because of complications or inadequate weight loss . CONCLUSIONS These first-generation implantable adjustable gastric b and results suggest that this is a viable bariatric surgery therapeutic option for the treatment of obesity",
"OBJECTIVE This study examined the clinical significance of loss of control ( LOC ) over eating in bariatric surgery patients over 24 months of prospect i ve , multiwave follow-ups . METHOD Three hundred sixty-one gastric bypass surgery patients completed a battery of assessment s before surgery and at 6 , 12 , and 24 months following surgery . In addition to weight loss and LOC over eating , the assessment s targeted eating disorder psychopathology , depression levels , and quality of life . The study was conducted between January 2002 and February 2008 . RESULTS Prior to surgery , 61 % of patients reported general LOC ; postsurgery , 31 % reported LOC at 6-month follow-up , 36 % reported LOC at 12-month follow-up , and 39 % reported LOC at 24-month follow-up . Preoperative LOC did not predict postoperative outcomes . In contrast , mixed models analyses revealed that postsurgery LOC was predictive of weight loss outcomes : patients with LOC postsurgery lost significantly less weight at 12-month ( 34.6 % vs 37.2 % BMI loss ) and 24-month ( 35.8 % vs 39.1 % BMI loss ) postsurgery follow-ups . Postsurgery LOC also significantly predicted eating disorder psychopathology , depression , and quality of life at 12- and 24-month postsurgery follow-ups . CONCLUSIONS Preoperative LOC does not appear to be a negative prognostic indicator for postsurgical outcomes . Postoperative LOC , however , significantly predicts poorer postsurgical weight loss and psychosocial outcomes at 12 and 24 months following surgery . Since LOC following bariatric surgery significantly predicts attenuated postsurgical improvements , it may signal a need for clinical attention",
"Background / Aims : Improving health-related quality of life ( HRQoL ) along with decreasing obesity-related morbidity is one of the cornerstones of bariatric surgery . The aim of the study was to investigate how losing weight influences the HRQoL 1 year after gastric bypass and whether HRQoL prior to surgery predicts the amount of weight loss 1 year after gastric bypass . Methods : One hundred and thirty-nine obese women [ median ( range ) : age 45 years ( 20–71 ) , BMI 44 ( 29–88 ) ] admitted for gastric bypass were selected prospect ively and completed the Nottingham Health Profile ( NHP ) quality of life question naire before and 1 year after surgery . Results : Weight loss 1 year after gastric bypass was significant [ –37 kg ( 9–74 ) , p improvement of quality of life [ NHP total score before surgery 62 ( 39–76 ) and after surgery 20 ( 7–65 ) , p HRQoL improves dramatically 1 year after gastric bypass . This HRQoL improvement is not influenced by the amount of weight loss , but rather by the BMI achieved at that time",
"OBJECTIVE The goal of this study was to examine the safety and effectiveness of the LAP-B AND System for patients with 30 - 39.9 BMI and associated comorbidities . DESIGN AND METHODS In this prospect i ve , multicenter , interventional cohort study , subjects with a BMI between 30 and 39.9 who had failed prior weight loss attempts were recruited from 7 surgical centers . The primary effectiveness endpoint required that > 40 % of subjects achieve ≥30 % excess weight loss ( EWL ) at 1 year . Secondary endpoints included assessment of comorbidities and quality -of-life . RESULTS Of 149 subjects , 90.6 % were female , with mean BMI of 35.3 kg/m2 . At 1 year , 84.6 % of subjects achieved ≥30 % EWL ( P ) . Baseline comorbidities improved at 1 year for 64.4 % with dyslipidemia , 59.6 % with hypertension , and 85.7 % with diabetes . Quality -of-life ( IWQOL-Lite ) also improved ( P with an increase in IWQOL-Lite by 7.1 points and a decrease in triglycerides by 13.7 mg/dL , fasting glucose by 3.5 mg/dL , and systolic blood pressure by 3.3 mmHg . Most adverse events were mild to moderate and resolved without sequelae within 1 month . Five subjects ( 3.4 % ) had explantations . CONCLUSION LAGB is safe and effective for people with 30 - 39.9 BMI , with weight loss and comorbidity improvement through at least 2 years",
"Background The aggressive pursuit of weight loss in the elderly remains a controversial objective . In this series of 113 patients over 60 years of age who underwent laparoscopic gastric b and ing surgery , we report on complications , co-morbidity change , quality -of-life improvement and changes in medication use over a median follow-up period of 25.5 months . Methods A prospect ively kept data base was review ed from January 1999 to September 2008 identifying patients over 60 who underwent gastric b and ing surgery . Baseline and follow-up SF-36 ® survey scores were compared longitudinally . Co-morbidity change and medication use were assessed by question naire and electronic record review . Results Major complications were experienced by 7.1 % over the follow-up period with a re-operation rate of 15.0 % . Excess BMI loss was 44.1 % after 5 years and combined mean SF-36 ® quality -of-life scores ( out of 100 ) improved 22.1 points , achieving parity with age-matched norms for the general population . Diabetes improved in 74.2 % with hypertension , hyperlipidaemia and depression improving in 57.1 , 51.1 and 35.9 % of cases . A significant drop in medication use was not seen , and cancer was responsible for three deaths over the follow-up period . No surgical mortality was incurred . Conclusion Laparoscopic gastric b and ing can markedly improve quality of life for morbidly obese over 60s . Health gains are significant , but medication use is not substantially altered . Gastric b and ing is an ideal weight loss operation for this age group due to its safety and efficacy , and the primary goal should be quality -of-life improvement "
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BACKGROUND AND AIMS The effect of statin therapy on plasma adiponectin levels has not been conclusively studied . Therefore , we aim ed to evaluate this effect through a systematic review and meta- analysis of available r and omized controlled trials ( RCTs ) . METHODS Quantitative data synthesis was performed using a r and om-effects model with weighted mean difference ( WMD ) and 95 % confidence interval ( CI ) as summary statistics . RESULTS In 30 studies ( 43 study arms ) with 2953 participants , a significant increase in plasma adiponectin levels was observed after statin therapy ( WMD : 0.57 μg/mL , 95 % CI : 0.18 , 0.95 , p = 0.004 ) . In subgroup analysis , atorvastatin , simvastatin , rosuvastatin , pravastatin and pitavastatin were found to change plasma adiponectin concentrations by 0.70 μg/mL ( 95 % CI : -0.26 , 1.65 ) , 0.50 μg/mL ( 95 % CI : -0.44 , 1.45 ) , -0.70 μg/mL ( 95 % CI : -1.08 , -0.33 ) , 0.62 μg/mL ( 95 % CI : -0.12 , 1.35 ) , and 0.51 μg/mL ( 95 % CI : 0.30 , 0.72 ) , respectively . With respect to duration of treatment , there was a significant increase in the subset of trials lasting ≥12 weeks ( WMD : 0.88 μg/mL , 95 % CI : 0.19 , 1.57 , p = 0.012 ) but not in the subset of statin-induced elevation of plasma adiponectin and changes in plasma low density lipoprotein cholesterol levels ( slope : 0.04 ; 95 % CI : 0.01 , 0.06 ; p = 0.002 ) . CONCLUSIONS The meta- analysis showed a significant increase in plasma adiponectin levels following statin therapy . Although statins are known to increase the risk for new onset diabetes mellitus , our data might suggest that the mechanism for this is unlikely to be due to a reduction in adiponectin expression
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"We investigated the effect of pioglitazone in comparison with and in combination with simvastatin on insulin resistance , plasma adiponectin , postpr and ial plasma glucose , insulin , and intact proinsulin levels in a nondiabetic population at cardiovascular risk . One hundred twenty-five nondiabetic patients at cardiovascular risk were r and omized to pioglitazone ( PIO ) , pioglitazone and simvastatin ( PIO/SIM ) , or simvastatin ( SIM ) treatments . Blood sample s were taken for the measurement of adiponectin and lipid levels . In addition , an oral glucose load with the measurements of glucose , insulin , and intact proinsulin levels was performed . Adiponectin levels increased from 14.0+/-8.2 to 27.6+/-14.5 microg/mL ( P adiponectin levels from 15.5+/-12.7 to 11.6+/-7.0 microg/mL ( P fasting intact proinsulin levels remained unchanged , the increase in postpr and ial intact proinsulin levels could be reduced from 29.5+/-21.4 to 22.1+/-17.5 pmol/L ( P Lipid parameters improved during SIM treatment but not during PIO treatment . Combined treatment with PIO/SIM was superior in improving overall cardiovascular risk profile than every single drug",
"Background —Biological mechanisms underlying statin and angiotensin II type 1 receptor blocker therapies differ . Therefore , we compared vascular and metabolic responses to these therapies either alone or in combination in hypercholesterolemic , hypertensive patients . Methods and Results —This was a r and omized , double-blind , placebo-controlled crossover trial with 3 treatment arms ( each 2 months ) and 2 washout periods ( each 2 months ) . Forty-seven hypertensive , hypercholesterolemic patients were given simvastatin 20 mg and placebo , simvastatin 20 mg and losartan 100 mg , or losartan 100 mg and placebo daily during each 2-month treatment period . Losartan alone or combined therapy significantly reduced blood pressure compared with simvastatin alone . Compared with losartan alone , simvastatin alone or combined therapy significantly changed lipoproteins . All 3 treatment arms significantly improved flow-mediated dilator response to hyperemia and decreased plasma malondialdehyde and monocyte chemoattractant protein-1 levels relative to baseline measurements . However , these parameters were changed to a greater extent with combined therapy compared with simvastatin or losartan alone ( both P Combined therapy or losartan alone significantly increased plasma adiponectin levels and insulin sensitivity ( determined by QUICKI ) relative to baseline measurements . These changes were significantly greater than in the group treated with simvastatin alone ( P losartan improves endothelial function and reduces inflammatory markers to a greater extent than monotherapy with either drug in hypercholesterolemic , hypertensive patients",
"OBJECTIVES Statins and fibrates alter lipids , apolipoproteins and inflammatory markers in persons without HIV . The objective of this study was to evaluate changes in lipoproteins , apolipoproteins and other markers of inflammation with the use of pravastatin and fenofibrate . DESIGN Evaluation of participants in ACTG A5087 , a r and omized trial of pravastatin 40 mg/day or fenofibrate 200 mg/day for the treatment of dyslipidemia . Participants that failed single-agent therapy at week 12 were given the combination . METHODS Participants with available specimens were tested for apolipoproteins A1 and B , adiponectin , plasminogen-activator inhibitor type 1 ( PAI-1 ) , P-selectin , and high-sensitivity C-reactive protein ( hs-CRP ) . RESULTS 74 participants ( 37 per r and omized arm ) received either pravastatin or fenofibrate for 12 weeks with 60 receiving combination treatment from weeks 12 - 48 . There were no significant changes in hs-CRP , PAI-1 , and P-selectin . From baseline to week 12 , the median Apo B levels (-8 mg/dL , P=0.01 for fenofibrate and -27 mg/dL , P pravastatin ) and ApoB/A1 ratios ( -0.16 , P median adiponectin ( -1 ng/dL , P Apo B ( -22 mg/dL , P Apo B/A1 ratios ( -0.2 , P Apo A1 ( 9.5 mg/dL , P=0.01 ) levels increased . CONCLUSION Treatment with pravastatin or fenofibrate improves the atherogenic lipid profile within the first 12 weeks and is sustained through 48 weeks with combination therapy . Adiponectin levels decrease with lipid-lowering therapy . However , markers of inflammation and platelet activation were not appreciably changed suggesting that the biologic properties of these agents differ in persons with HIV infection",
"OBJECTIVES We investigated whether atorvastatin might decrease insulin sensitivity and increase ambient glycemia in hypercholesterolemic patients . BACKGROUND Clinical trials suggest that some statin treatments might increase the incidence of diabetes despite reductions in low-density lipoprotein ( LDL ) cholesterol and improvement in endothelial dysfunction . METHODS A r and omized , single-blind , placebo-controlled parallel study was conducted in 44 patients taking placebo and in 42 , 44 , 43 , and 40 patients given daily atorvastatin 10 , 20 , 40 , and 80 mg , respectively , during a 2-month treatment period . RESULTS Atorvastatin 10 , 20 , 40 , and 80 mg significantly reduced LDL cholesterol ( 39 % , 47 % , 52 % , and 56 % , respectively ) and apolipoprotein B levels ( 33 % , 37 % , 42 % , and 46 % , respectively ) after 2 months of therapy when compared with either baseline ( all p fasting plasma insulin ( mean changes : 25 % , 42 % , 31 % , and 45 % , respectively ) and glycated hemoglobin levels ( 2 % , 5 % , 5 % , and 5 % , respectively ) when compared with either baseline ( all p insulin sensitivity ( 1 % , 3 % , 3 % , and 4 % , respectively ) when compared with either baseline ( p = 0.312 , p = 0.008 , p fasting insulin and glycated hemoglobin levels consistent with insulin resistance and increased ambient glycemia in hypercholesterolemic patients . ( Effects of Atorvastatin on Adiponectin Levels and Insulin Sensitivity In Hypercholesterolemic Patients ; NCT00745836 )",
"Little is known about the effect of exercise training on the expression of adiponectin receptor genes in peripheral blood mononuclear cells ( P BMC s ) . In this study , we investigated the effects of aerobic training on the expression of AdipoR1 and AidpoR2 mRNAs in P BMC s , whole body insulin sensitivity , and circulating adiponectins in men . Thirty young men were r and omly assigned to either a control ( n=15 ) or an exercise ( n=15 ) group . Subjects assigned to the exercise group underwent a 12-week jogging and /or running programme on a motor-driven treadmill at an intensity of 60%-75 % of the age-based maximum heart rate with duration of 40 minutes per session and a frequency of 5 days per week . Two-way mixed ANOVA with repeated measures was used to test any significant time-by-group interaction effects for the measured variables at p=0.05 . We found significant time-by-group interaction effects for waist circumference ( p=0.001 ) , VO2max ( p fasting insulin ( p=0.016 ) , homeostasis model assessment for insulin resistance ( HOMA-IR ) ( p=0.010 ) , area under the curve ( AUC ) for insulin response during the 75-g oral glucose tolerance test ( p=0.002 ) , high-molecular weight ( HMW ) adiponectin ( p=0.016 ) , and the P BMC mRNA levels of AdipoR1 ( p AdipoR2 ( p=0.001 ) . The exercise group had significantly increased mRNA levels of AdipoR1 and AdipoR2 in P BMC s , along with increased whole body insulin sensitivity and HMW adiponectin , decreased waist circumference , and increased VO2max compared with the control group . In summary , the current findings suggest that exercise training modulates the expression of AdipoR1 and AdipoR2 mRNAs in P BMC s , implying that manipulation of the expression of these genes could be a potential surrogate for lifestyle intervention-mediated improvements of whole body insulin sensitivity and glucose homeostasis",
"Reduction of serum cholesterol levels with statin therapy decreases the risk of coronary heart disease . Inhibition of HMG-CoA reductase by statin results in decreased synthesis of cholesterol and other products downstream of mevalonate , which may produce adverse effects in statin therapy . We studied the reductions of serum ubiquinol-10 and ubiquinone-10 levels in hypercholesterolemic patients treated with atorvastatin . Fourteen patients were treated with 10 mg/day of atorvastatin , and serum lipid , ubiquinol-10 and ubiquinone-10 levels were measured before and after 8 weeks of treatment . Serum total cholesterol and LDL-cholesterol levels decreased significantly . All patients showed definite reductions of serum ubiquinol-10 and ubiquinone-10 levels , and mean levels of serum ubiquinol-10 and ubiquinone-10 levels decreased significantly from 0.81 + /- 0.21 to 0.46 + /- 0.10 microg/ml ( p Percent reductions of ubiquinol-10 and those of total cholesterol showed a positive correlation ( r = 0.627 , p = 0.0165 ) . As atorvastatin reduces serum ubiquinol-10 as well as serum cholesterol levels in all patients , it is imperative that physicians are forewarned about the risks associated with ubiquinol-10 depletion",
"OBJECTIVE Pravastatin has been reported to elevate circulating adiponectin levels in patients with various insulin resistant state , hypertension , coronary artery disease , and hypercholesterolemia . This study aim ed to evaluate whether pravastatin increase serum total and high molecular weight adiponectin levels and improve insulin sensitivity in female patients with type 2 diabetes mellitus and hypercholesterolemia . PATIENTS AND DESIGN This study was design ed as a multicenter , double-blind , placebo-controlled , factorial r and omized trial ( placebo and pravastatin at 20 or 40 mg per day ) . A total of 73 female patients with type 2 diabetes and hypercholesterolemia were enrolled . Changes in total and high molecular weight ( HMW ) serum adiponectin levels , the ratio of HMW adiponectin to total adiponectin , insulin sensitivity measured by homeostasis model assessment of insulin resistance ( HOMA-IR ) and lipid profiles were evaluated after 16 weeks in each group . RESULTS Total cholesterol and low-density lipoprotein ( LDL ) cholesterol levels were significantly reduced after 16 weeks in the pravastatin 20 mg and 40 mg treatment groups compared with the placebo group ( P = 0.008 and P = 0.004 , respectively ) . However , there were no significant differences between the 20 mg and 40 mg pravastatin treatment groups in terms of total adiponectin and HMW adiponectin serum levels , as well as insulin sensitivity ( P = 0.348 and P = 0.991 ) . CONCLUSIONS In female patients with type 2 diabetes and hypercholesterolemia , 16 weeks pravastatin therapy did not affect on serum total adiponectin or HMW adiponectin levels",
"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",
"Pravastatin increases the plasma adiponectin level . We examined whether this is a statins ' class effect or specific to pravastatin . Of 50 patients undergoing cardiac surgery for coronary artery disease ( CAD , n = 36 ) and valvular heart disease ( VHD , n = 14 ) , 23 with CAD and serum LDL-cholesterol level > 100 mg/dL were r and omized to pravastatin at 10 mg/day ( PRAVA , n = 12 ) or rosuvastatin at 2.5 mg/day ( ROSUVA , n = 11 ) for 2 months , and the other 13 with CAD and LDL-cholesterol ≤100 mg/dL were not treated with statin ( Non-statin , n = 13 ) . Patients with VHD did not have CAD and were not treated with statin . Blood was sample d at baseline and surgery . Visceral ( VIS ) and subcutaneous ( SC ) adipose tissues were harvested during surgery . At baseline , the plasma adiponectin level was low in patients with CAD compared with that of patients with VHD . At surgery , adiponectin level in PRAVA was increased to the level in VHD , whereas those in ROSUVA and Non-statin were unchanged . VIS contents and gene expressions of adiponectin in PRAVA and VHD were similar to each other and were both higher than those in Non-statin and ROSUVA . SC content and gene expression of adiponectin were similar among 4 groups . Protein carbonyl ( PC ) level , an indicator of oxidative stress , in VIS was lower in PRAVA and VHD than in ROSUVA and Non-statin . There was a negative correlation between the plasma adiponectin and VIS PC levels ( r = -0.41 , P 0.05 ) . Thus , pravastatin increases adiponectin generation , whereas rosuvastatin does not",
"BACKGROUND The effect of statins on insulin resistance is controversial and poorly studied in nondiabetic subjects . In addition , the effect of statins on leptin and adiponectin has never been studied . METHODS Forty healthy nondiabetic volunteers ( 22 men and 18 women ) aged 28 to 72 were r and omized either to placebo or pravastatin 40 mg daily for a 12-week period . Insulin resistance , assessed using the Quantitative Insulin Sensitivity Check Index ( QUICKI ) , as well as serum leptin and adiponectin levels , was measured at baseline and at the end of therapy . RESULTS Pravastatin treatment decreased total cholesterol , low-density lipoprotein cholesterol , and triglycerides levels by 24 % , 32 % , and 14 % , respectively ( P glucose and insulin levels , the ( QUICKI ) index , and adiponectin and leptin levels . When stratification was performed according to QUICKI index or sex , no significant differences were observed in the prevalues and postvalues of leptin , adiponectin , or QUICKI index in the pravastatin group . Adiponectin , leptin , and QUICKI index were statistically higher in women than in men ( P Adiponectin was negatively correlated with body mass index ( BMI ; r = -0.39 , P QUICKI index ( r = 0.54 , P high-density lipoprotein cholesterol ( r = 0.50 , P adiponectin and QUICKI index remained significant after adjustment for sex and BMI ( P = .005 and P = .007 , respectively ) . Leptin was only related to BMI ( r = 0.57 , P leptin ( P pravastatin 40 mg/d does not change the QUICKI index and leptin and adiponectin levels in healthy volunteers . In addition , our results emphasize the importance of sex and BMI in the determination of both adiponectin and leptin . Adiponectin was also related to QUICKI index , whereas this relation was not found with leptin",
"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",
"OBJECTIVE Diabetes , a major health problem worldwide , increases the risk of cardiovascular disease and its associated mortality : The Long-Term Intervention with Pravastatin in Ischemic Disease ( LIPID ) trial showed that cholesterol-lowering treatment with pravastatin reduced mortality and coronary heart disease ( CHD ) events in 9014 patients aged 31 - 75 years with CHD and total cholesterol 4.0 - 7.0 mmol/l . We measured the effects of pravastatin therapy , 40 mg/day over 6.0 years , on the risk of CHD death or nonfatal myocardial infa rct ion and other cardiovascular outcomes in 1,077 LIPID patients with diabetes and 940 patients with impaired fasting glucose ( IFG ) . RESULTS In patients allocated to placebo , the risk of a major CHD event was 61 % higher in patients with diabetes and 23 % higher in the IFG group than in patients with normal fasting glucose , and the risk of any cardiovascular event was 37 % higher in the diabetic group and 19 % higher in the IFG group . Pravastatin therapy reduced the risk of a major CHD event overall from 15.9 to 12.3 % ( relative risk reduction [ RRR ] 24 % , P Pravastatin reduced the risk of any cardiovascular event from 52.7 to 45.2 % ( 21 % , P Pravastatin reduced the risk of stroke from 9.9 to 6.3 % in the diabetic group ( RRR 39 % , CI 7 - 61 % , P = 0.02 ) and from 5.4 to 3.4 % in the IFG group ( RRR 42 % , CI -9 to 69 % , P = 0.09 ) . Pravastatin did not reduce the incidence of diabetes . Over 6 years , pravastatin therapy prevented one major CHD event ( CHD death or nonfatal myocardial infa rct ion ) in 23 patients with IFG and 18 patients with diabetes . A meta- analysis of other major trials confirmed the high absolute risks of diabetes and IFG and the absolute benefits of statin therapy in these patients . CONCLUSIONS Cholesterol-lowering treatment with pravastatin therapy prevents cardiovascular events , including stroke , in patients with diabetes or IFG and established CHD",
"OBJECTIVE Concerns regarding worsening insulin sensitivity associated with statin treatment have recently emerged . Therefore the aim of this study was to assess and compare the effects of 90-day monotherapies with fenofibrate and atorvastatin , as well as combined therapy , on fasting plasma glucose , insulin resistance index , adipokines ( leptin , resistin , adiponectin ) and levels of proinflammatory cytokines ( TNF-α , IL-6 ) in patients with impaired fasting glucose ( IFG ) and mixed hyperlipidemia . MATERIAL S AND METHODS 67 patients were r and omly assigned to four treatment arms : monotherapy with atorvastatin , monotherapy with fenofibrate , combined therapy ( fenofibrate and torvastatin ) or therapeutic lifestyle change . The study lasted for 90 days . All participants received counseling regarding proper diet and physical activity . RESULTS Compared to the control subjects , prediabetic patients exhibited elevated plasma levels of leptin , resistin , TNF-α and IL-6 , and a lower plasma level of adiponectin . All therapeutic interventions result ed in significant alterations in the lipid profile . Insulin resistance index ( HOMA-IR ) was reduced after treatment with fenofibrate . The effect of atorvastatin on insulin resistance was comparable to therapeutic lifestyle change alone . Therapy with hypolipidemic drugs caused increases in adiponectin levels and decreases in leptin and resistin . An additive effect of the combined treatment on plasma IL-6 level was also observed . CONCLUSIONS Fenofibrate-based treatment was associated with improved insulin sensitivity . Atorvastatin did not cause a deterioration in insulin sensitivity . Hypolipidemic therapies result ed in significant changes in the proinflammatory cytokine network as well as in adipokine levels . At the end of the study the measured parameters nearly resembled those of the healthy subjects",
"Abstract Aims : Statin treatment may impair glucose homeostasis and increase the risk of new-onset diabetes mellitus , although this may depend on the statin , dose and patient population . We evaluated the effects of pitavastatin 4 mg/day on glucose homeostasis in patients with metabolic syndrome in the CAPITAIN trial . Findings were vali date d in a subset of patients enrolled in PREVAIL-US . Methods : Participants with a well defined metabolic syndrome phenotype were recruited to CAPITAIN to reduce the influence of confounding factors . Validation and comparison data sets were selected comprising phenotypically similar subsets of individuals enrolled in PREVAIL-US and treated with pitavastatin or pravastatin , respectively . Mean change from baseline in parameters of glucose homeostasis ( fasting plasma glucose [ FPG ] , glycated hemoglobin [ HbA1c ] , insulin , quantitative insulin-sensitivity check index [ QUICKI ] and homeostasis model of assessment –insulin resistance [ HOMA-IR ] ) and plasma lipid profile were assessed at 6 months ( CAPITAIN ) and 3 months ( PREVAIL-US ) after initiating treatment . Results : In CAPITAIN ( n = 12 ) , no significant differences from baseline in HbA1c , insulin , HOMA-IR and QUICKI were observed at day 180 in patients treated with pitavastatin . A small ( 4 % ) increase in FPG from baseline to day 180 ( P glycemic parameters were observed at day 84 ( all comparisons P > 0.05 ) . Similar results were observed for pravastatin in the comparison data set ( n = 14 ) . Conclusions : Other than a small change in FPG in the CAPITAIN study , neutral effects of pitavastatin on glucose homeostasis were observed in two cohorts of patients with metabolic syndrome , independent of its efficacy in reducing levels of atherogenic lipoproteins . The small number of patients and relatively short follow-up period represent limitations of the study . Nevertheless , these data suggest that statin-induced diabetogenesis may not represent a class effect",
"OBJECTIVE Although previous studies suggest that treatment of dyslipidemia with statins reduces mortality and morbidity that are associated with cardiovascular disease , only a few studies have examined the efficacy of statins on atherosclerotic status in patients with chronic kidney disease ( CKD ) . MATERIAL S AND METHODS A 12-month , prospect i ve , r and omized study was design ed to assess the efficacy of rosuvastatin in reducing circulating atherosclerotic parameters and renal function in patients with CKD . Thirty-eight patients with CKD and LDL cholesterol levels > or = 100 mg/dL were r and omly assigned to receive 2.5 mg/dL rosuvastatin ( group A , n=22 ) or nonrosuavastatin therapy ( group B , n=16 ) . Lipid profile , estimated glomerular filtration rate ( eGFR ) , high sensitivity C-reactive protein ( hs-CRP ) , and intima-media thickness ( IMT ) were measured before and 12 months after rosuvastatin was added to the treatment . RESULTS Total cholesterol , low-density lipoprotein cholesterol , remnant-like particle-cholesterol and triglycerides were significantly reduced only in patients who received rosuvastatin . These parameters remained unchanged in patients who were not treated with rosuvastatin . eGFR was significantly increased from 50.7+/-18.7 mL/min/1.73 m(2 ) to 53.3+/-20.1 mL/min/1.73 m(2 ) and a significant reduction of U-P was detected in group A patients ( 0.17+/-0.29 vs. 0.13+/-0.3 g/day ; p rosuvastatin treatment significantly reduced hs-CRP ( p=0.0054 ) . Moreover , maximal IMT at the baseline ( 1.89+/-0.98 mm ) decreased significantly to 1.75+/-0.87 mm at 12 months ( p=0.0231 ) . CONCLUSION Rosuvastatin treatment , in addition to its beneficial effect on cholesterol levels , reduced maximal IMT and modified the inflammatory state of these patients"
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41172404-06ff-11f0-808a-c43d1ab1c353
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Pycnogenol is a st and ardized extract from the bark of the French maritime pine . The aim of the present systematic review and meta- analysis was to clarify the effect of Pycnogenol supplementation on C-reactive protein ( CRP ) concentration . To identify eligible studies in order to find clinical trials which examined the effect of Pycnogenol supplementation on the level of CRP in adult participants , PubMed , Scopus , and Google Scholar were systematic ally search ed until December 2017 . Mean of CRP was collected to estimate the effect size of the supplementation . Potential sources of heterogeneity were explored by subgroup analysis . Five trials including 324 participants were included in this meta- analysis . Pooled effect size showed significant effect of Pycnogenol supplementation on CRP ( -1.22 mg/dL , 95 % confidence interval , -2.43 , -0.003 ; I2 = 99 % , pheterogeneity of Pycnogenol , heterogeneity was attenuated in > 150 mg/d category ( I2 = 0.0 % , p = 0.42 ) . There was significant difference between-subgroup heterogeneity ( p publication bias for CRP ( p = 0.27 , Begg 's test and p = 0.62 , Egger 's test ) was seen . Present systematic review and meta- analysis suggested Pycnogenol consumption can decrease the level of CRP and have anti-inflammatory effect . So , Pycnogenol as an anti-inflammatory agent might be a priority in interventions . Further studies with large-scale and better design are needed to confirm this result
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" Pycnogenol ® ( PYC ) , an extract of French maritime pine bark ( Pinus pinaster ) , is a potent antioxidant with potential health benefits . Its bioavailabilty has previously been shown by urinary excretion studies of constituents and metabolites of PYC . The aim of this study was to test the effect of PYC supplementation on measures of oxidative stress and the lipid profile in humans . Twenty-five healthy subjects received PYC ( 150 mg/d ) for 6 wk . Fasting blood was collected at baseline , after 3 and 6 wk of supplementation , and again after a 4-wk washout period . After 6 wk of supplementation with PYC , a significant increase in plasma polyphenol levels was detectable , which was reversed after the 4-wk washout phase . The antioxidant effect of PYC was demonstrated by a significant increase in oxygen radical absorbance capacity ( ORAC ) in plasma throughout the supplementation period ( P The ORAC value returned to baseline after the 4-wk washout period . Moreover , in addition to its antioxidant effects , PYC significantly reduced LDL-cholesterol levels and increased HDL-cholesterol levels in plasma of two-thirds of the subjects . While the LDL changes reversed during washout , the HDL increase did not . There was no significant difference in LDL oxidizability or plasma lipid peroxides following PYC supplementation . Hence , following oral supplementation in humans , PYC significantly increases antioxidant capacity of plasma , as determined by ORAC , and exerts favorable effects on the lipid profile",
"BACKGROUND Although modifiable cardiovascular disease risk factors are common , some patients eschew conventional drug treatments in favor of natural alternatives . Pine bark extract , a dietary supplement source of antioxidant oligomeric proanthocyanidin complexes , has multiple putative cardiovascular benefits . Studies published to date about the supplement have notable method ological limitations . METHODS We r and omized 130 individuals with increased cardiovascular disease risk to take 200 mg of a water-based extract of pine bark ( n = 64 ; Toyo-FVG , Toyo Bio-Pharma , Torrance , California ; Shinyaku Co , Ltd , Saga , Japan ; also marketed as Flavagenol in Japan ) or placebo ( n = 66 ) once per day . Blood pressure , our primary outcome , and other cardiovascular disease risk factors were measured at baseline and at 6 and 12 weeks . Statistical analyses were conducted using regression models . RESULTS Baseline characteristics did not differ between the study groups . Over the 12-week intervention , the sum of systolic and diastolic blood pressures decreased by 1.0 mm Hg ( 95 % confidence interval , -4.2 to 2.1 mm Hg ) in the pine bark extract-treated group and by 1.9 mm Hg ( -5.5 to 1.7 mm Hg ) in the placebo group ( P = .87 ) . Other outcomes were likewise not significantly different , including body mass index , lipid panel measures , liver transaminase test results , lipoprotein cholesterol particle size , and levels of insulin , lipoprotein(a ) , fasting glucose , and high-sensitivity C-reactive protein . There were no subgroups for whom intake of pine bark extract affected cardiovascular disease risk factors . CONCLUSIONS This pine bark extract ( at a dosage of 200 mg/d ) was safe but was not associated with improvement in cardiovascular disease risk factors . Although variations among participants , dosages , and chemical preparations could contribute to different findings compared with past studies , our results are consistent with a general failure of antioxidants to demonstrate cardiovascular benefits . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00425945",
"AIMS Extracts from pine tree bark containing a variety of flavonoids have been used in traditional medicine . Pycnogenol is a proprietary bark extract of the French maritime pine tree ( Pinus pinaster ssp . atlantica ) that exerts antioxidative , anti-inflammatory , and anti-platelet effects . However , the effects of Pycnogenol on endothelial dysfunction , a precursor of atherosclerosis and cardiovascular events , remain still elusive . METHODS AND RESULTS Twenty-three patients with coronary artery disease ( CAD ) completed this r and omized , double-blind , placebo-controlled cross-over study . Patients received Pycnogenol ( 200 mg/day ) for 8 weeks followed by placebo or vice versa on top of st and ard cardiovascular therapy . Between the two treatment periods , a 2-week washout period was scheduled . At baseline and after each treatment period , endothelial function , non-invasively assessed by flow-mediated dilatation ( FMD ) of the brachial artery using high-resolution ultrasound , biomarkers of oxidative stress and inflammation , platelet adhesion , and 24 h blood pressure monitoring were evaluated . In CAD patients , Pycnogenol treatment was associated with an improvement of FMD from 5.3 ± 2.6 to 7.0 ± 3.1 ( P observed with placebo ( 5.4 ± 2.4 to 4.7 ± 2.0 ; P = 0.051 ) . This difference between study groups was significant [ estimated treatment effect 2.75 ; 95 % confidence interval ( CI ) : 1.75 , 3.75 , P 0.0001 ] . 15-F(2t)-Isoprostane , an index of oxidative stress , significantly decreased from 0.71 ± 0.09 to 0.66 ± 0.13 after Pycnogenol treatment , while no change was observed in the placebo group ( mean difference 0.06 pg/mL with an associated 95 % CI ( 0.01 , 0.11 ) , P = 0.012 ] . Inflammation markers , platelet adhesion , and blood pressure did not change after treatment with Pycnogenol or placebo . CONCLUSION This study provides the first evidence that the antioxidant Pycnogenol improves endothelial function in patients with CAD by reducing oxidative stress",
"CONTEXT A prior national survey documented the high prevalence and costs of alternative medicine use in the United States in 1990 . OBJECTIVE To document trends in alternative medicine use in the United States between 1990 and 1997 . DESIGN Nationally representative r and om household telephone surveys using comparable key questions were conducted in 1991 and 1997 measuring utilization in 1990 and 1997 , respectively . PARTICIPANTS A total of 1539 adults in 1991 and 2055 in 1997 . MAIN OUTCOMES MEASURES Prevalence , estimated costs , and disclosure of alternative therapies to physicians . RESULTS Use of at least 1 of 16 alternative therapies during the previous year increased from 33.8 % in 1990 to 42.1 % in 1997 ( P herbal medicine , massage , megavitamins , self-help groups , folk remedies , energy healing , and homeopathy . The probability of users visiting an alternative medicine practitioner increased from 36.3 % to 46.3 % ( P = .002 ) . In both surveys alternative therapies were used most frequently for chronic conditions , including back problems , anxiety , depression , and headaches . There was no significant change in disclosure rates between the 2 survey years ; 39.8 % of alternative therapies were disclosed to physicians in 1990 vs 38.5 % in 1997 . The percentage of users paying entirely out-of-pocket for services provided by alternative medicine practitioners did not change significantly between 1990 ( 64.0 % ) and 1997 ( 58.3 % ) ( P=.36 ) . Extrapolations to the US population suggest a 47.3 % increase in total visits to alternative medicine practitioners , from 427 million in 1990 to 629 million in 1997 , thereby exceeding total visits to all US primary care physicians . An estimated 15 million adults in 1997 took prescription medications concurrently with herbal remedies and /or high-dose vitamins ( 18.4 % of all prescription users ) . Estimated expenditures for alternative medicine professional services increased 45.2 % between 1990 and 1997 and were conservatively estimated at $ 21.2 billion in 1997 , with at least $ 12.2 billion paid out-of-pocket . This exceeds the 1997 out-of-pocket expenditures for all US hospitalizations . Total 1997 out-of-pocket expenditures relating to alternative therapies were conservatively estimated at $ 27.0 billion , which is comparable with the projected 1997 out-of-pocket expenditures for all US physician services . CONCLUSIONS Alternative medicine use and expenditures increased substantially between 1990 and 1997 , attributable primarily to an increase in the proportion of the population seeking alternative therapies , rather than increased visits per patient ",
"There is evidence from several studies that supplementation with French maritime pine bark extract ( Pycnogenol ) improves inflammatory symptoms in vivo . However , the molecular pharmacological basis for the observed effects has not been fully uncovered yet . Direct inhibitory effects of plant extracts or components upon cyclooxygenase ( COX ) activity have been repeatedly reported , but the question remained whether sufficiently high in vivo concentrations of bioactive compounds could be achieved in humans . The purpose of the present study was to determine a possible inhibition of the enzymatic activity of COX-1 and COX-2 by serum sample s of human volunteers after intake of French maritime pine bark extract . This methodology considered that the serum sample s would contain any bioavailable active principle . Therefore , we obtained blood sample s before and after 5 days administration of 200 mg Pycnogenol to five healthy humans . The plasma moderately inhibited both COX-1 and COX-2 activities ex vivo . In a second approach , 10 volunteers received a single dose of 300 mg Pycnogenol . Only 30 min after ingestion of the pine bark extract the serum sample s induced a statistically significant increase in the inhibition of both COX-1 ( P COX-2 ( P rapid bioavailability of bioeffective compounds after oral intake of the extract . Thus , we provide evidence that Pycnogenol exerts effects by inhibition of eicosanoid generating enzymes which is consistent with reported clinical anti-inflammatory and platelet inhibitory effects in vivo . The next challenge is to identify the active principle(s ) that are rapidly bioavailable in human plasma",
"BACKGROUND The aim of the study was the evaluation of the efficacy of Pycnogenol ® in peri-menopausal women in controlling homocysteine and C-reactive protein ( CRP ) levels , borderline cardiovascular risk factors , oxidative stress ( OS ) and symptoms associated to menopausal transition ( MT ) . METHODS Pycnogenol ® , 100mg/day , was used as a supplement for 8 weeks by a group of 35 women . A comparable group of 35 women with identical cardiovascular risk factors was included as the control group . All women were instructed to participate in a best management plan of menopause . RESULTS The two groups were comparable . All women completed the eight weeks study . Only minor deviations from the best management plan were observed . At inclusion , both groups were similar in respect to risk factors . Supplementation with Pycnogenol ® decreased the slightly elevated cholesterol and triglycerides after 8 weeks ( P the fasting glucose levels were normalized ( P borderline increased blood pressure was reduced to normal values at 8 weeks ( P ) . Plasma free radicals dropped significantly by 22 % ( P decreased sharply by 43 % and 60 % , respectively ( P menopausal symptoms , scored by The Menopausal Symptoms Question naire 34 , improved significantly following supplementation with Pycnogenol ® . The supplementation was well tolerated . CONCLUSIONS The supplementation with Pycnogenol ® improved the quality of life of perimenopausal women and normalized a series of cardiovascular risk factors , especially factors connected to cardiovascular events , as homocysteine and CRP",
"This study evaluated the effects of Pycnogenol as an adjunct to angiotensin-converting enzyme (ACE)-inhibitor ramipril treatment of hypertensive patients presenting with early signs of renal function problems . One group of 26 patients was medicated with 10 mg ramipril per day only ; a second group of 29 patients took Pycnogenol in addition to the ACE inhibitor over a period of 6 months . At trial end , a lowered systolic and diastolic blood pressure was found in both groups , with a significant further reduction of diastolic pressure in the group given Pycnogenol in addition to ramipril . The major aim of this study was the investigation of kidney-protective effects of Pycnogenol . Urinary albumin decreased from 87 ± 23 to 64 ± 16 mg/d with ramipril only . Additional Pycnogenol lowered albumin significantly better from 91 ± 25 to 39 ± 13 mg/day ( P groups , serum creatinine was lowered ; however , only in the combination treatment group did the effect reached statistical significance . In both groups , CRP levels decreased from 2.1 to 1.8 with ramipril and from 2.2 to 1.1 with the ramipril — Pycnogenol combination ; the latter reached statistical significance . Kidney cortical flow velocity was investigated by Doppler color duplex ultrasonography . Both systolic and diastolic flow velocities increased significantly after 6 months medication with ramipril . The addition of Pycnogenol to the regimen statistically significantly further enhanced kidney cortical flow velocities , by 8 % for diastolic flow and 12 % for systolic flow , relative to values found for the group taking ramipril only . The protective effects of Pycnogenol for initial kidney damage found in this study warrant further research with a larger number of patients and over a longer period of time"
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4117244a-06ff-11f0-808a-c43d1ab1c353
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Despite intensive efforts to underst and the extent to which skeletal muscle mitochondrial capacity changes in older humans , the answer to this important question remains unclear . To determine what the preponderance of evidence from in vivo studies suggests , we conducted a systematic review and meta- analysis of the effects of age on muscle oxidative capacity as measured noninvasively by magnetic resonance spectroscopy . A secondary aim was to examine potential moderators contributing to differences in results across studies , including muscle group , physical activity status , and sex . C and i date papers were identified from PubMed search es ( n = 3561 papers ) and the reference lists of relevant papers . St and ardized effects ( Hedges ' g ) were calculated for age and each moderator using data from the 22 studies that met the inclusion criteria ( n = 28 effects ) . Effects were coded as positive when older ( age , ≥55 years ) adults had higher muscle oxidative capacity than younger ( age , 20 - 45 years ) adults . The overall effect of age on oxidative capacity was positive ( g = 0.171 , p oxidative capacity in old . Notably , there was significant heterogeneity in this result ( Q = 245.8 , p . Muscle group , physical activity , and sex were all significant moderators of oxidative capacity ( p ≤ 0.029 ) . This analysis indicates that the current body of literature does not support a de facto decrease of in vivo muscle oxidative capacity in old age . The heterogeneity of study results and identification of significant moderators provide clarity regarding apparent discrepancies in the literature , and indicate the importance of accounting for these variables when examining purported age-related differences in muscle oxidative capacity
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"Despite distinct differences between walking and running , the two types of human locomotion are likely to be controlled by shared pattern-generating networks . However , the differences between their kinematics and kinetics imply that corresponding muscle activations may also be quite different . We examined the differences between walking and running by recording kinematics and electromyographic ( EMG ) activity in 32 ipsilateral limb and trunk muscles during human locomotion , and compared the effects of speed ( 3 - 12 km/h ) and gait . We found that the timing of muscle activation was accounted for by five basic temporal activation components during running as we previously found for walking . Each component was loaded on similar sets of leg muscles in both gaits but generally on different sets of upper trunk and shoulder muscles . The major difference between walking and running was that one temporal component , occurring during stance , was shifted to an earlier phase in the step cycle during running . These muscle activation differences between gaits did not simply depend on locomotion speed as shown by recordings during each gait over the same range of speeds ( 5 - 9 km/h ) . The results are consistent with an organization of locomotion motor programs having two parts , one that organizes muscle activation during swing and another during stance and the transition to swing . The timing shift between walking and running reflects therefore the difference in the relative duration of the stance phase in the two gaits",
"This study determined the decline in oxidative capacity per volume of human vastus lateralis muscle between nine adult ( mean age 38.8 years ) and 40 elderly ( mean age 68.8 years ) human subjects ( age range 25 - 80 years ) . We based our oxidative capacity estimates on the kinetics of changes in creatine phosphate content ( [ PCr ] ) during recovery from exercise as measured by (31)P magnetic resonance ( MR ) spectroscopy . A matched muscle biopsy sample permitted determination of mitochondrial volume density and the contribution of the loss of mitochondrial content to the decline in oxidative capacity with age . The maximal oxidative phosphorylation rate or oxidative capacity was estimated from the PCr recovery rate constant ( k(PCr ) ) and the [ PCr ] in accordance with a simple electrical circuit model of mitochondrial respiratory control . Oxidative capacity was 50 % lower in the elderly vs. the adult group ( 0.61 + /- 0.04 vs. 1.16 + /- 0.147 mM ATP s(-1 ) ) . Mitochondrial volume density was significantly lower in elderly compared with adult muscle ( 2.9 + /- 0.15 vs. 3.6 + /- 0.11 % ) . In addition , the oxidative capacity per mitochondrial volume ( 0.22 + /- 0.042 vs. 0.32 + /- 0.015 mM ATP ( s % ) ( -1 ) ) was reduced in elderly vs. adult subjects . This study showed that elderly subjects had nearly 50 % lower oxidative capacity per volume of muscle than adult subjects . The cellular basis of this drop was a reduction in mitochondrial content , as well as a lower oxidative capacity of the mitochondria with age",
"Using (31)P magnetic resonance spectroscopy , creatine kinase ( CK ) reaction kinetics was assessed in the forearm flexor digitorum profundus muscle of healthy young ( n = 11 , age 34.7 + /- 5 yr ) and older ( n = 20 , age 73.5 + /- 8 yr ) subjects at rest , intermittent exercise at 20 % maximum voluntary contraction ( MVC ) , and 40 % MVC . Exercise result ed in a significant increase in the average ratio of inorganic phosphate ( P(i ) ) to phosphocreatine ( PCr ) from resting values of 0.073 + /- 0.031 ( young ) and 0.082 + /- 0.037 ( older ) to 0 . 268 + /- 0.140 ( young , P 40 % MVC , intracellular pH decreased significantly , from resting values of 7.08 + /- 0.08 ( young ) and 7.08 + /- 0.11 ( older ) to 6.84 + /- 0.19 ( young , P Average values of the pseudo-first-order reaction rate k((PCr-->ATP ) ) at rest were 0.07 + /- 0.04 s(-1 ) in the young and 0.07 + /- 0.03 s(-1 ) in the older group . At both exercise levels , the reaction rate constant increased compared with the resting value , but only the difference between the resting value and the 20 % MVC value , which showed an 86 % higher reaction rate constant in both groups , reached statistical significance ( P reaction rate constant between the young and older groups was observed at either exercise level . As with k((PCr-->ATP ) ) , the average phosphorus flux through the CK reaction increased during exercise at 20 % MVC ( P < 0.05 in the older group ) but decreased toward resting values at 40 % MVC in both groups . The data in our study suggest that normal aging does not significantly affect the metabolic processes associated with the CK reaction",
"BACKGROUND The decline in muscle mass ( sarcopenia ) with aging may be related to a decline in mitochondrial function . However , investigators have yet to reach a consensus as to whether a decline in mitochondrial function can be attenuated by physical activity has yet to reach a consensus . METHODS Using dynamic 31PMRS to measure mitochondrial function , we measured baseline Phosphocreatine ( PCr ) , inorganic phosphate ( Pi ) , phosphodiester ( PDE ) , [ ADP ] , pH and recovery times ( t(1/2 ) ) for PCr and [ ADP ] following exercise , in 45 older ( 73+/-4 years , SD ) , and 20 younger subjects ( 25+/-4 years , SD ) who were matched for body mass across high and low activity levels and within age and sex groupings . RESULTS Baseline PCr , and Pi , were lower , and PDE higher in the older subjects compared to younger subjects ( all P t(1/2)(ADP ) was longer in older subjects ( P t(1/2)(PCr ) was longer than high activity groups . Higher PDE levels were positively correlated with longer t(1/2)(PCr ) in the older low activity females ( both P mitochondrial function declines with age in healthy , exercising elderly adults and that the decline appears to be influenced by the level of physical activity"
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41172486-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To compare surgical versus medical treatment of type 2 diabetes mellitus ( T2DM ) remission and comorbidities in patients with a body mass index ( BMI ) less than 35 kg/m2 . BACKGROUND Obesity surgery can achieve remission of T2DM and its comorbidities . Metabolic surgery has been proposed as a treatment option for diabetic patients with BMI less than 35 kg/m2 but the efficacy of metabolic surgery has not been conclusively determined . METHODS A systematic literature search identified r and omized ( RCT ) and nonr and omized comparative observational clinical studies ( OCS ) evaluating surgical versus medical T2DM treatment in patients with BMI less than 35 kg/m2 . The primary outcome was T2DM remission . Additional analyses comprised glycemic control , BMI , HbA1c level , remission of comorbidities , and safety . R and om effects meta-analyses were calculated and presented as weighted odds ratio ( OR ) or mean difference ( MD ) with 95 % confidence intervals ( 95 % CI ) . RESULTS Five RCTs and 6 OCSs ( 706 total T2DM patients ) were included . Follow-up ranged from 12 to 36 months . Metabolic surgery was associated with a higher T2DM remission rate ( OR : 14.1 , 95 % CI : 6.7 - 29.9 , P higher rate of glycemic control ( OR : 8.0 , 95 % CI : 4.2 - 15.2 , P lower HbA1c level ( MD : -1.4 % , 95 % CI -1.9 % to -0.9 % , P treatment . BMI ( MD -5.5 kg/m2 , 95 % CI : -6.7 to -4.3 kg/m2 , P rate of arterial hypertension ( OR : 0.25 , 95 % CI : 0.12 - 0.50 , P dyslipidemia ( OR : 0.21 , 95 % CI : 0.10 - 0.44 , P Metabolic surgery is superior to medical treatment for short-term remission of T2DM and comorbidities . Further RCTs should address the long-term effects on T2DM complications and mortality
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[
"Abbreviations ACCORD Action to Control Cardiovascular Risk in Diabetes ADVANCE Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified-Release Controlled Evaluation AGI α-Glucosidase inhibitor CAD Coronary artery disease CKD Chronic kidney disease CVD Cardiovascular disease DPP-4 Dipeptidyl peptidase IV GIP Glucose-dependent insulinotropic peptide GLP-1 Glucagon-like peptide 1 NPH Neutral protamine Hagedorn TZD Thiazolidinedione UKPDS UK Prospect i ve Diabetes Study VADT Veterans Affairs Diabetes",
"Background Most morbidly obese patients who undergo gastric bypass experience rapid remission of type 2 diabetes mellitus ( T2DM ) but the response in non-morbidly obese patients is not clear . This trial prospect ively assessed the effect of diabetes remission , glucose metabolism , and the serial changes of insulin secretion after gastric bypass in inadequately controlled T2DM patients with a BMI of 23–35 kg/m2 . Methods A total of 62 consecutive patients with T2DM and a BMI of 23–35 kg/m2 underwent gastric bypass . Data were prospect ively collected before surgery and 1 , 4 , 12 , 26 , and 52 weeks and 2 years after surgery . Insulin secretion was measured by insulinogenic index and area under the curve ( AUC ) during a st and ard oral glucose tolerance test ( OGTT ) . Remission of type 2 diabetes was defined as fasting glucose level 62 patients , 24 were men and 38 were women ( age 43.1 ± 10.8 years ) . Their preoperative characteristics were as follows : BMI 30.1 ± 3.3 kg/m2 , waist circumference 99.6 ± 9.6 cm , C-peptide 3.1 ± 1.4 ng/ml , and duration of T2DM 5.4 ± 5.1 years . The mean BMI decreased postoperatively to 22.6 ± 2.3 kg/m2 in 1 year and 23.0 ± 2.7 kg/m2 in 2 years . The mean HbA1c decreased from 9.7 ± 1.9 % to 5.8 ± 0.5 % in 1 year and 5.9 ± 0.5 % in 2 years . Complete remission of T2DM was achieved in 57 % in 1 year and 55 % in 2 years after surgery . Before surgery , the OGTT test showed a blunted insulin secretion pattern with an insulinogenic index of 0.1 ± 0.2 and AUC of 2,324 ± 1,015 μIU min/ml . In 1 week after surgery , the insulinogenic index increased to 0.16 and AUC decreased to 1,366 μIU min/ml along with a rapid drop of insulin resistance . The insulinogenic index and AUC gradually increased to 0.27 and 3,220 , respectively , 1 year after surgery and remained stable up to 2 years with a very low insulin resistance . Conclusions Laparoscopic gastric bypass facilitates immediate improvement in the glucose metabolism of inadequately controlled non-severe obese T2DM patients , and the benefit is sustained up to 2 years after surgery . The benefit is regulated by the decrease in insulin resistance , increase in early insulin response , and total insulin secretion to glucose load",
"IMPORTANCE Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus . OBJECTIVE To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass ( RYGB ) surgery compared with an intensive diabetes medical and weight management ( Weight Achievement and Intensive Treatment [ Why WAIT ] ) program for type 2 diabetes . DESIGN , SETTING , AND PARTICIPANTS A 1-year pragmatic r and omized clinical trial was conducted in an academic medical institution . Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study ; their body mass index was 30 to 42 ( calculated as weight in kilograms divided by height in meters squared ) and hemoglobin A1c ( HbA1c ) was greater than or equal to 6.5 % . All participants were receiving antihyperglycemic medications . INTERVENTIONS RYGB ( n = 19 ) or Why WAIT ( n = 19 ) including 12 weekly multidisciplinary group lifestyle , medical , and educational sessions with monthly follow-up thereafter . MAIN OUTCOMES AND MEASURES Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA1c less than 6.5 % , measures of cardiometabolic health , and patient-reported outcomes . RESULTS At 1 year , the proportion of patients achieving HbA1c below 6.5 % and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT ( 58 % vs 16 % , respectively ; P = .03 ) . Other outcomes , including HbA1c , weight , waist circumference , fat mass , lean mass , blood pressure , and triglyceride levels , decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT . Improvement in cardiovascular risk scores was greater in the surgical group . At baseline the participants exhibited moderately low self-reported quality -of-life scores reflected by Short Form-36 total , physical health , and mental health , as well as high Impact of Weight on Quality of Life-Lite and Problem Areas in Diabetes health status scores . At 1 year , improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups . The Impact of Weight on Quality of Life-Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT . CONCLUSIONS AND RELEVANCE In obese patients with type 2 diabetes , RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management , with emergent differences over 1 year . Both treatments improve general quality -of-life measures , but RYGB provides greater improvement in the effect of weight on quality of life . These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger r and omized trials are performed . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01073020",
"Background Type 2 diabetes mellitus ( T2DM ) is a disease with high prevalence , associated with severe co-morbidities as well as being a huge burden on public health . It is known that glycemic control decreases long-term morbidity and mortality . The current st and ard therapy for T2DM is medical treatment . Several r and omized controlled trials ( RCTs ) performed in obese patients showed remission of T2DM after bariatric surgery . Recent RCTs have shown bariatric procedures to produce a similar effect in non-morbidly and non-severely obese , insulin-dependent T2DM patients suggesting procedures currently used in bariatric surgery as new therapeutical approach in patients with T2DM . This study aims at investigating whether Roux-en-Y gastric bypass ( RYGB ) is an efficient treatment for non-severely obese T2DM patients in terms of preventing long-term complications and mortality . Methods The DiaSurg 2 trial is a multicenter , open r and omized controlled trial comparing RYGB including st and ardized medical treatment if needed to exclusive st and ardized medical treatment of T2DM ( control group ) . The primary endpoint is a composite time-to-event endpoint ( cardiovascular death , myocardial infa rct ion , coronary bypass , percutaneous coronary intervention , non-fatal stroke , amputation , surgery for peripheral atherosclerotic artery disease ) , with a follow-up period of 8 years . Insulin-dependent T2DM patients aged between 30 and 65 years will be included and r and omly assigned to one of the two groups . The experimental group will receive RYGB and , if needed , st and ardized medical care , whereas the control group will receive exclusive st and ardized medical care , both according to the national treatment guidelines for T2DM . Statistical analysis is based on Cox proportional hazards regression for the intention-to-treat population . Assuming a loss to follow-up rate of 20 % , 200 patients will be r and omly allocated to the comparison groups . A total sample size of n = 400 is sufficient to ensure 80 % power in a two-tailed significance test at alpha = 5 % . Discussion The DiaSurg2 trial will yield long-term data ( 8 years ) on diabetes-associated morbidity and mortality in patients with insulin-dependent T2DM receiving either RYGB or st and ardized medical care . Trial registration The trial protocol has been registered in the German Clinical Trials Register DRKS00004550",
"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",
"AIMS The aim of this study was to evaluate the effect of laparoscopic Roux-en-Y gastric bypass ( RYGB ) surgery compared with usual care with and without Exenatide therapy in obese people with type 2 diabetes mellitus ( T2DM ) and hypertension . METHODS 108 obese T2DM with hypertension were enrolled and r and omly allocated to usual care ( group A ) , usual care plus Exenatide ( group B ) , and RYGB surgery ( group C ) . Demographic characteristics , metabolic parameters and cardiac structure/function along with inflammatory cytokines were measured and compared before and after 12 months . RESULTS At 12 months , diabetes remission had occurred in no patients in groups A and B versus 90 % in group C , and there was a significant decrease in requirement of antihypertensive drugs in group C compared with groups A and B ( P ( body mass index , hemoglobin A1c , homeostasis model assessment of insulin resistance , lipids ) , inflammation index ( high sensitivity C-reactive protein , tumor necrosis factor-α , high molecular weight adiponectin ) and cardiac structure ( left ventricular mass index ) were significantly improved in groups B and C , but patients in group C had the greatest degree of improvement ( P CONCLUSION RYGB surgery improves a number of parameters including cardiovascular function in obese hypertensive people with T2DM . This is likely to be due to , at least in part , an improvement in the abnormal metabolic panel and to reduced inflammation",
"Objective : Surprisingly , 40 % to 95 % of patients with type 2 diabetes mellitus ( T2DM ) show early remission of hyperglycemia after obesity surgery . It is unknown to what extent other diabetes-associated comorbidities such as distal peripheral neuropathy ( DPN ) might be influenced by obesity surgery . This pilot study aim ed at providing further evidence for the impact of Roux-en-Y gastric bypass ( RYGB ) on both glycemic control and DPN in nonseverely obese patients with insulin-dependent T2DM . Methods : In the present prospect i ve cohort study , 20 patients with long-st and ing , insulin-dependent T2DM and a body mass index ( BMI ) between 25 and 35 kg/m2 underwent laparoscopic RYGB . Body mass index , glycosylated hemoglobin ( HbA1c ) , and DPN [ quantified by the Neuropathy Symptom Score ( NSS ) and the Neuropathy Deficit Score ( NDS ) ] were investigated . Results : Six months after surgery , the preoperative BMI of 32.8 ± 2.1 kg/m2 ( mean ± st and ard deviation ) dropped to 25.6 ± 2.5 kg/m2 ( P 0.001 ) . Preoperative HbA1c levels decreased from 8.5 ± 1.2 % to 7.1 ± 1.2 % ( P normalized HbA1c level lower than 6.2 % . Of 12 patients with documented DPN , the median NSS was 8 ( range , 0–10 ) preoperatively and 0 ( range , 0–9 ) postoperatively ( P = 0.004 ) , with 8 patients scoring an NSS of 0 . The median NDS was 6 ( range , 2–8 ) preoperatively and 4 ( range , 0–8 ) postoperatively ( P = 0.027 ) , with 1 patient scoring an NDS of 0 . All patients had an improvement or normalization in either 1 or both scores . Conclusions : As expected , BMI and HbA1c levels improved significantly after RYGB . More interestingly , neuropathy scores , such as NSS and NDS , improved significantly early after surgery . Symptomatic neuropathy was completely reversible in 67 % of the patients . These findings add further evidence to the fact that RYGB might be a valuable treatment option not only for improving glycemic control but also for reducing diabetes-associated comorbidities , such as DPN . This points to a complex metabolic effect of RYGB that exceeds glucose normalization . However , the results still need to be confirmed in controlled trials",
"The efficacy of Roux-en-Y gastric bypass ( RYGB ) to control type 2 diabetes mellitus ( T2DM ) has been demonstrated in morbidly obese patients . Surgical procedures primarily focused on T2DM control in patients with body mass index ( BMI ) remission of T2DM . However , only few reports have evaluated the safety and efficacy of RYGB in this group of patients . The aim of this study is to assess the safety and efficacy of RYGB in TD2 M patients with BMI laparoscopic RYGB were included . Safety of the procedure was evaluated according to mortality , need of reoperation/conversion , and complication rates . Metabolic parameters were evaluated at baseline and 6 , 12 , and 24 months after surgery . Thirty patients were included . Seventeen ( 56.6 % ) were women . Age , BMI , and duration of diabetes were 48 ± 9 years , 33.7 ± 1.2 kg/m2 , 4 ± 2.9 years , respectively . No mortality was observed . No conversion/reoperation was needed . Average length of stay was 3.2 ± 0.9 days . Early and late postoperative complications were observed in five ( 16.6 % ) and five ( 16.6 % ) patients , respectively . Twelve months after surgery , remission was observed in 25 of 30 patients ( 83.3 % ) . After 2 years , remission was achieved in 13 of 20 patients ( 65 % ) , and hemoglobin A1c decreased from 8.1 ± 1.8 % to 5.9 ± 1.1 % and homeostasis model assessment of insulin resistance from 5.7 ± 3.2 to 1.9 ± 0.8 after 12 months . RYGB is a safe and effective procedure to induce T2DM remission in otherwise not eligible patients for bariatric surgery . Evidence from prospect i ve studies is needed to vali date this approach",
"IMPORTANCE Many questions remain unanswered about the role of bariatric surgery for people with type 2 diabetes mellitus ( T2DM ) . OBJECTIVE To determine feasibility of a r and omized clinical trial ( RCT ) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating T2DM in participants with grade s I and II obesity . DESIGN , SETTING , AND PARTICIPANTS A 12-month , 3-arm RCT at a single center including 69 participants aged 25 to 55 years with a body mass index ( calculated as weight in kilograms divided by height in meters squared ) of 30 to 40 and T2DM . INTERVENTIONS Roux-en-Y gastric bypass ( RYGB ) , laparoscopic adjustable gastric b and ing ( LAGB ) , and an intensive lifestyle weight loss intervention ( LWLI ) . MAIN OUTCOMES AND MEASURES Primary outcomes in the intention-to-treat cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control . RESULTS Of 667 potential participants who underwent screening , 69 ( 10.3 % ) were r and omized . Among the r and omized participants , 30 ( 43 % ) had grade I obesity , and 56 ( 81 % ) were women . Mean ( SD ) age was 47.3 ( 6.4 ) years and hemoglobin A1c level , 7.9 % ( 2.0 % ) . After r and omization , 7 participants ( 10 % ) refused to undergo their allocated intervention ( 3 RYGB , 1 LAGB , and 3 LWLI ) , and 1 RYGB participant was excluded for current smoking . Twenty participants underwent RYGB ; 21 , LAGB ; and 20 , LWLI , with 12-month retention rates of 90 % , 86 % , and 70 % , respectively . In the intention-to-treat cohort with multiple imputation for missing data , RYGB participants had the greatest mean weight loss from baseline ( 27.0 % ; 95 % CI , 30.8 - 23.3 ) compared with LAGB ( 17.3 % ; 95 % CI , 21.1 - 13.5 ) and LWLI ( 10.2 % ; 95 % CI , 14.8 - 5.61 ) ( P Partial and complete remission of T2DM were 50 % and 17 % , respectively , in the RYGB group and 27 % and 23 % , respectively , in the LAGB group ( P remission in the LWLI group . Significant reductions in use of antidiabetics occurred in both surgical groups . No deaths were noted . The 3 serious adverse events included 1 ulcer treated medically in the RYGB group and 2 rehospitalizations for dehydration in the LAGB group . CONCLUSIONS AND RELEVANCE This study highlights several potential challenges to successful completion of a larger RCT for treatment of T2DM and obesity in patients with a body mass index of 30 to 40 , including the difficulties associated with recruiting and r and omizing patients to surgical vs nonsurgical interventions . Preliminary results show that RYGB was the most effective treatment , followed by LAGB for weight loss and T2DM outcomes at 1 year . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01047735",
"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 Bariatric surgery improves glycaemia in obese people with type 2 diabetes , but its effects are uncertain in overweight people with this disease . We aim ed to identify whether laparoscopic adjustable gastric b and surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese . METHODS We did an open-label , parallel-group , r and omised controlled trial between Nov 1 , 2009 , and June 30 , 2013 , at one centre in Melbourne , Australia . Patients aged 18 - 65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were r and omly assigned ( 1:1 ) , by computer-generated r and om sequence , to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric b and surgery or multidisciplinary diabetes care alone . The primary outcome was diabetes remission 2 years after r and omisation , defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose , at least two days after stopping glucose-lowering drugs . Analysis was by intention to treat . This trial is registered with the Australian New Zeal and Clinical Trials Registry , number ACTRN12609000286246 . FINDINGS 51 patients were r and omised to the multidisciplinary care plus gastric b and group ( n=25 ) or the multidisciplinary care only group ( n=26 ) , of whom 23 participants and 25 participants , respectively , completed follow-up to 2 years . 12 ( 52 % ) participants in the multidisciplinary care plus gastric b and group and two ( 8 % ) participants in the multidisciplinary care only group achieved diabetes remission ( difference in proportions 0.44 , 95 % CI 0.17 - 0.71 ; p=0.0012 ) . One ( 4 % ) participant in the gastric b and group needed revisional surgery and four others ( 17 % ) had a total of five episodes of food intolerance due to excessive adjustment of the b and . INTERPRETATION When added to multidisciplinary care , laparoscopic adjustable gastric b and surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile . Laparoscopic adjustable gastric b and surgery is a reasonable treatment option for this population . FUNDING Monash University Centre for Obesity Research and Education and Allergan",
"BACKGROUND In short-term r and omized trials ( duration , 1 to 2 years ) , bariatric surgery has been associated with improvement in type 2 diabetes mellitus . METHODS We assessed outcomes 3 years after the r and omization of 150 obese patients with uncontrolled type 2 diabetes to receive either intensive medical therapy alone or intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy . The primary end point was a glycated hemoglobin level of 6.0 % or less . RESULTS The mean ( ±SD ) age of the patients at baseline was 48±8 years , 68 % were women , the mean baseline glycated hemoglobin level was 9.3±1.5 % , and the mean baseline body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 36.0±3.5 . A total of 91 % of the patients completed 36 months of follow-up . At 3 years , the criterion for the primary end point was met by 5 % of the patients in the medical-therapy group , as compared with 38 % of those in the gastric-bypass group ( P The use of glucose-lowering medications , including insulin , was lower in the surgical groups than in the medical-therapy group . Patients in the surgical groups had greater mean percentage reductions in weight from baseline , with reductions of 24.5±9.1 % in the gastric-bypass group and 21.1±8.9 % in the sleeve-gastrectomy group , as compared with a reduction of 4.2±8.3 % in the medical-therapy group ( P for both comparisons ) . Quality -of-life measures were significantly better in the two surgical groups than in the medical-therapy group . There were no major late surgical complications . CONCLUSIONS Among obese patients with uncontrolled type 2 diabetes , 3 years of intensive medical therapy plus bariatric surgery result ed in glycemic control in significantly more patients than did medical therapy alone . Analyses of secondary end points , including body weight , use of glucose-lowering medications , and quality of life , also showed favorable results at 3 years in the surgical groups , as compared with the group receiving medical therapy alone . ( Funded by Ethicon and others ; STAMPEDE Clinical Trials.gov number , NCT00432809 . )"
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411724c2-06ff-11f0-808a-c43d1ab1c353
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It is commonly assumed that a person identifying that they are ' overweight ' is an important prerequisite to successful weight management . However , there has been no systematic evaluation of evidence supporting this proposition . The aim of the present research was to systematic ally review evidence on the relationship between perceived overweight and ( i ) weight loss attempts , ( ii ) weight control strategies ( healthy and unhealthy ) , ( iii ) weight-related behaviours ( physical activity and eating habits ) , ( iv ) disordered eating and ( v ) weight change . We synthesized evidence from 78 eligible studies and evaluated evidence linking perceived overweight with outcome variables separately according to the gender , age and objective weight status of study participants . Results indicated that perceived overweight was associated with an increased likelihood of attempting weight loss and with healthy and unhealthy weight control strategies in some participant groups . However , perceived overweight was not reliably associated with physical activity or healthy eating and was associated with greater disordered eating in some groups . Rather than being associated with improved weight management , there was consistent evidence that perceived overweight was predictive of increased weight gain over time . Individuals who perceive their weight status as overweight are more likely to report attempting weight loss but over time gain more weight
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"Background : Obesity is a well-known cause of cardiovascular disease burden and premature death , but effects on depressive symptoms remain equivocal . Depressive symptoms may be more common among the obese individuals who perceive themselves as overweight , rather than those who perceive themselves as having an acceptable weight . Our aim was to determine whether weight status and weight perceptions are independently associated with psychological distress . Methods : We conducted a cross-sectional study using data from the Australian National Health Survey 2004–2005 ( N=17 253 ) . All variables were collected by self-report . Adjusted multinomial logistic regression analysis was conducted to generate prevalence odds ratios with 95 % confidence intervals ( 95 % CI ) for medium ( Kessler Psychological Distress Scale ( K10 ) scores of 20–29 ) and high ( K10 scores of 30–50 ) psychological distress ( compared with K10 scores of 10–19 as the reference ) associated with weight status ( st and ard body mass index ( BMI ) cutoffs for underweight , overweight and obesity vs normal weight ) , weight perception ( perceived underweight and overweight vs acceptable weight ) and weight misperception ( incorrect with BMI vs correct with BMI ) adjusting for numerous important covariates . Results : Overweight and underweight perception increased the odds of medium ( 40 and 50 % ) and high ( 50 and 120 % ) psychological distress , whereas weight status and weight misperception were not associated with psychological distress in adjusted analysis . Gender , alcohol consumed per week and post-school education were not significant covariates ( at P medium and high psychological distress prevalence and effects appear to be uniform for men and women . Well- design ed prospect i ve studies are still needed to determine whether weight perceptions cause psychological distress , and if so , whether symptoms are significantly reduced following effective intervention",
"OBJECTIVE To estimate the prevalence of abnormal eating attitudes among Greek adolescents and identify possible risk factors associated with these attitudes . DESIGN Cross-sectional , school-based study . SETTING Six r and omly selected schools in Patras , southern Greece . PARTICIPANTS The study population consisted of 540 Greek students aged 13 - 18 years , and the response rate was 97 % . MAIN OUTCOME MEASURE The dependent variable was scores on the Eating Attitudes Test-26 , with scores > or = 20 indicating abnormal eating attitudes . ANALYSIS Bivariate analysis included independent Student t test , chi-square test , and Fisher 's exact test . Multivariate logistic regression analysis was applied for the identification of the predictive factors , which were associated independently with abnormal eating attitudes . A 2-sided P value of less than .05 was considered statistically significant . RESULTS The prevalence of abnormal eating attitudes was 16.7 % . Multivariate logistic regression analysis demonstrated that females , urban residents , and those with a body mass index outside normal range , a perception of being overweight , body dissatisfaction , and a family member on a diet were independently related to abnormal eating attitudes . CONCLUSIONS AND IMPLICATION S The results indicate that a proportion of Greek adolescents report abnormal eating attitudes and suggest that multiple factors contribute to the development of these attitudes . These findings are useful for further research into this topic and would be valuable in design ing preventive interventions",
"Background There exists a dearth of prospect i ve adolescent eating disorder studies with sample s that are large enough to detect small or medium sized effects for risk factors , that are generalizable to the broader population , and that follow adolescents long enough to fully capture the period of development when the risk of eating disorder symptoms occurring is highest . As a result , the purpose of this study was to examine psychosocial risk factors for purging for weight control in a nationally representative sample of adolescents . Data were extracted from the restricted-use data sets of the National Longitudinal Study of Adolescent Health ( Waves I-III ) , selecting females with valid demographic and purging information ( N = 5,670 ) . Results The prevalence of purging was 0.88 % at Wave II and 0.56 % at Wave III . In multivariable multinomial logistic regressions , purging at Wave II was predicted by parental poverty and low levels of self-esteem at Wave I ; purging at Wave III was predicted by body mass index and the frequency of delinquent behaviors at Wave I. Conclusions Individuals with high body mass index , individuals with low self-esteem , and individuals in families experiencing economic hardship appear specifically at risk for the development of purging behaviors in later years and may benefit from more targeted prevention efforts",
"Background / Objective : The purpose of this study was to examine the longitudinal effects of body size over- and underestimation and other psychosocial factors on the risk for onset of overweight ( OW ) or obesity ( OB ) 1 year later among US adolescents . Subjects/ Methods : Participants with non-missing height and weight were drawn from the first two waves of the National Longitudinal Study of Adolescent to Adult Health ( n=13 568 ) . Multinomial logistic regressions were conducted to assess longitudinal risk factors for OW and OB onset , controlling for baseline weight status , age , race/ethnicity , parent education and family structure . Analyses were stratified by sex . Results : Compared with accurate body size perception , body size overestimation increased the relative risk ( RR ) of OW onset among women and men ( RR=3.34 , confidence interval (CI)=2.39–4.68 ; RR=6.01 , CI=4.09–8.83 , respectively , P the RR of OW onset among women and men ( RR= 0.08 , CI=0.03–0.20 ; RR=0.13 , CI=0.06–0.27 , respectively ) and OB onset ( RR=0.05 , CI=0.02–0.14 ; RR=0.19 , CI=0.08–0.47 , respectively , P Dieting , extreme weight loss behaviors and skipping breakfast at Wave 1 increased the risk of OB onset by Wave 2 . Conclusions : Contrary to a common assumption , body size underestimation did not increase , but in fact decreased , the RR for the onset of OW and of OB among adolescents using a prospect i ve longitudinal design . However , body size overestimation predicted onset of OW 1 year later . Body size self-concept and other psychosocial factors have an important role in risk for OW and for OB among both males and females during adolescence",
"BackgroudThe purpose of this study was to describe actual measured weight and perceived weight and to explore associations with depressive , anxiety symptoms in school adolescents in China . Methods A sample of 1144 Chinese adolescents was r and omly selected from four schools in Wuhan , China , including 665 boys and 479 girls with ages ranging between 10 and 17 years . Actual measured weight and height and perceived weight status were compared to anxiety and depressive symptoms measured using the revised Self-Rating Anxiety Scale and Children 's Depression Inventory . A general linear model was used to compare differences in psychological symptoms among the teenagers with different measured and perceived weights . Results When compared with st and ardized weight tables ( WHO age- and gender-specific body mass index ( BMI ) cutoffs ( 2007 reference ) ) , girls were more likely to misperceive themselves as overweight , whereas more boys misclassified their weight status as underweight . The adolescents who perceived themselves as overweight were more likely to experience depressive and anxiety symptoms ( except girls ) than those who perceived themselves as normal and /or underweight . However , no significant association was found between depressive and anxiety symptoms actual measured weight status . Conclusions Perceived weight status , but not the actual weight status , was associated with psychological symptoms ",
"OBJECTIVE To examine the association between perceived overweight in adolescents and the development of overweight or obesity later in life . METHODS This paper uses data from a prospect i ve , two-wave cohort study . Participants are 2445 adolescents 11 - 17years of age who reported perceived weight at baseline and also had height and weight measured at baseline and at follow-up six years later sample d from managed care groups in a large metropolitan area . RESULTS Youths who perceived themselves as overweight at baseline were approximately 2.5 times as likely to be overweight or obese six years later compared to youths who perceived themselves as average weight ( OR=2.45 , 95 % CI=1.77 - 3.39 ) , after adjusting for weight status at baseline , demographic characteristics , major depression , physical activity and dieting behaviors . Those who perceived themselves as skinny were less likely to be overweight or obese later ( OR=0.36 , 95 % CI=0.27 - 0.49 ) . CONCLUSIONS Perceived overweight was associated with overweight or obesity later in life . This relationship was not fully explained by extreme weight control behaviors or major depression . Further research is needed to explore the mechanism involved",
"OBJECTIVES This study aim ed to investigate the association between body-weight ( BW ) perception , weight preoccupation and behaviour , including weight control practice s and compulsive over-eating episodes , across gender and actual BW classes . DESIGN This study used a cross-sectional observational study . PARTICIPANTS A large , nationally representative sample of 6404 ninth- grade French adolescents was r and omly selected from schools throughout France . METHODS Weight and height were measured , and BW preoccupation , BW control practice s and compulsive over-eating were self-reported using st and ardized question naires . RESULTS Nearly one-third of adolescents misperceived their BW . Misperception was more frequent among girls than boys ( 42.2 % vs. 27.3 % , P Underestimation of BW among overweight adolescents , like BW overestimation among underweight adolescents , was associated with less preoccupation with weight and fewer weight control practice s than accurate perception of BW . Normal weight adolescents who overestimated their BW were more likely to declare weight preoccupations ( ORa = 8.66 [ 6.67 - 11.25 ] ) , dieting ( ORa = 4.81 [ 3.68 - 6.27 ] ) and recurrent compulsive over-eating episodes ( ORa = 2.36 [ 1.72 - 3.23 ] ) compared with their counterparts who correctly estimated their BW . CONCLUSION Our study underlines the role of these associations in each category of actual BW ( underweight , normal weight and overweight ) in a large national sample",
"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",
"OBJECTIVES We examined whether factors associated with attempting to lose weight in a hospital-based employee workforce varied by race/ethnicity . METHODS We conducted a cross-sectional survey in 6 hospitals in a health system in central Massachusetts . The stratified r and om sample included 813 employees ; men and and non-White employees were over sample d. The primary outcome measure was current evidence -based weight loss attempts . RESULTS Factors positively associated with attempting to lose weight among non-Hispanic Blacks included self-perceived overweight , female sex , higher education , physician recommendation to lose weight , and having a chronic medical condition . Among Hispanics , body mass index and self-perceived overweight were associated with attempts to lose weight , while working full time and second or third shift were associated with lower likelihood of weight loss attempts . Among non-Hispanic Whites , self-perceived overweight , female sex , higher education , and physician recommendation to lose weight were positively associated with attempting to lose weight , while working full time and working third shift were negatively associated . CONCLUSIONS Rates of overweight and obesity were high among hospital employees . Findings suggest that factors associated with attempting to lose weight vary across racial and ethnic groups . Workplace-based interventions for weight control should include strategies tailored to these differences",
"Adolescence obesity and depression are increasingly prevalent and are associated with various health complications . The aim of this study was to examine the association between weight status ( normal weight , overweight , and obese ) and depressive symptoms in adolescents and to explore the probable mediators , including overweight perception , greater weight concern , and dietary restraint . During the period October 2010 to January 2011 , we recruited 869 adolescents ( 47 % girls ; median age , 15.7 years ) from four r and omly selected high schools in Taipei city . The students were stratified into normal weight , overweight , or obese groups according to age- and gender-specific body mass index st and ards . Depressive symptoms were defined in students with a score of 29 or greater on the Center for Epidemiologic Studies Depression Scale . Overall , weight status was significantly associated with depressive symptoms ( P = 0.02 ) . Weight status was strongly associated with perceived overweight , greater weight concern , and dietary restraint . Those three variables were also associated with depressive symptoms . The association between overweight and depressive symptoms ( odds ratio , 2.23 ; 95 % confidence interval , 1.30–3.82 ) became weaker after controlling for perceived overweight , greater weight concern , and dietary restraint . The association between weight status and depressive symptoms in adolescents was partly mediated by perceived overweight , greater weight concern , and dietary restraint . Further prospect i ve cohort studies are needed to explore the association between weight status and depressive symptoms ",
"OBJECTIVE The objective of the study is to examine the relationship between weight-control behaviors and self-reported sociodemographic characteristics , weight status , and perception of body weight in a large , representative sample of adolescents in the West Bank and Gaza Strip territories of Palestine . METHOD Self-report measures of sociodemographic characteristics , body weight perception , height and weight , and weight-control behaviors were completed by 8,885 male and female students aged 12 - 18 years from 405 r and omly selected schools as part of the 2003/2004 Palestinian Health Behavior in School-aged Children Study ( HBSC ) . RESULTS In both genders , dieting to lose weight was common among adolescents and significantly higher among overweight than among underweight or normal weight adolescents . Extreme weight-control behaviors ( vomiting , diet pills , or laxatives ) and smoking were more common among boys than girls , and extreme weight-control behaviors were particularly common among underweight boys . Older adolescents were less likely than younger adolescents to engage in weight-control behaviors . Perception of body weight as too fat was an influential factor in following an unhealthy diet to lose weight . DISCUSSION Practice s to control weight , particularly extreme and unhealthy weight-control behaviors , are common among adolescents in the Palestinian territories . These findings suggest the need to design appropriate prevention and early intervention programs for adolescents in Palestine",
"Identifying oneself as being overweight may be associated with adverse health outcomes , yet prospect i ve tests of this possibility are lacking . Over 7 years , we examined associations between perceptions of being overweight and subsequent health in a sample of 3,582 U.S. adults . Perceiving oneself as being overweight predicted longitudinal declines in subjective health ( d = −0.22 , p increases in depressive symptoms ( d = 0.09 , p raised levels of physiological dysregulation ( d = 0.24 , p body mass index to contribute to unhealthy profiles of physiological functioning and impaired health over time . These findings underscore the importance of evaluating whether weight-feedback interventions may have unforeseen adverse consequences",
"Background / Objective : Weight misperception is common among adolescents with obesity , but it is not known whether weight perception is related to future weight gain . The objective of the study was to examine the prospect i ve association between accurate weight perception versus weight misperception and weight change among youth who are overweight or obese . Subjects/ Methods : Using a sub sample of The National Longitudinal Study of Adolescent to Adult Health Wave II cohort , we used linear regression modeling ( adjusted for age , baseline body mass index ( BMI ) , parental education , household percent federal poverty level , depression , race and ethnicity ) to examine the prospect i ve association between weight misperception ( that is , perceiving oneself to be under or normal weight ) among 2738 overweight and obese youth and subsequent BMI change from Wave II ( 1996 ) to Wave IV ( 2008–2009 ) . Mean age at baseline ( Wave II ) was 15.9 ( 0.1 ) . Results : Fifty-seven percent of males and 80 % of females accurately perceived themselves as overweight . In fully adjusted models , weight misperception was associated with less BMI gain among youth who were overweight and obese . Specifically , youth who perceived themselves to be at a healthy weight had lower BMI gains ( males : β= −1.43 , 95 % confidence interval (CI)=(−2.26 , −0.60 ) , P=0.001 ; females : β= −1.35 , 95 % CI=(−2.59 , −0.11 ) , P=0.035 ) from Wave II to IV relative to those who accurately perceived themselves as overweight or obese . Conclusions : Contrary to commonly held assumptions , weight misperception among a non- clinical sample of youth who were overweight or obese predicted lower future weight gain . Efficacy of efforts to correct weight misperception should be rigorously examined to assess for both intended and unintended consequences",
"OBJECTIVE With increasing frequency , health promotion messages advocating physical activity are cl aim ing weight loss as a benefit . However , messages promoting physical activity as a weight loss strategy may have limited effectiveness and cross-cultural relevance . We recently found self-perceived overweight to be a more robust correlate of sedentary behavior than BMI in Los Angeles County adults . In this study , we examined ethnic and sex differences in overweight self-perception and their association with sedentariness in this sample . RESEARCH METHODS AND PROCEDURES We conducted bivariate and multivariate analyses of cross-sectional survey data from a representative sample of Los Angeles County adults . RESULTS Women were more likely to perceive themselves to be overweight than men overall ( 73.2 % of overweight/non-obese and 24.1 % of average weight women vs. 44.5 % of overweight/non-obese and 5.6 % of average weight men ) and within each ethnic group . African-Americans were least likely ( 41.3 % of overweight/non-obese African-Americans self-identified as overweight ) and whites were most likely to consider themselves overweight ( 60.6 % of overweight/non-obese whites self-identified as overweight ) . Overweight ( vs. average weight ) self-perception was correlated with sedentariness among average weight adults ( 45.3 % vs. 33.0 % , p whites ( 41.9 % vs. 29.7 % , p = 0.0012 ) , and African-Americans and Latinos ( 41.6 % vs. 33.9 % , p = 0.005 ) . DISCUSSION These data suggest that our society 's emphasis on weight loss rather than lifestyle change may inadvertently discourage physical activity adoption/maintenance among non-obese individuals . However , further research is needed , particularly from prospect i ve cohort and intervention studies , to eluci date the relationship between overweight self-perception and healthy lifestyle change",
"Abstract Objective : To determine if inaccurate body weight perception predicts unhealthy weight management strategies and to determine the extent to which inaccurate body weight perception is associated with depressive symptoms among US college students . Participants : R and omly selected male and female college students in the United States ( N = 97,357 ) . Methods : Data were from the 2006 National College Health Assessment . Analyses were conducted on students ’ body weight perceptions , weight loss strategies , and feelings of depression . Results : Females with an inflated body weight perception were significantly more likely to engage in unhealthy weight management strategies and report depressive symptoms than were females with an accurate body weight perception . Conclusions : College women are concerned with weight and will take action to lose weight . Colleges may need to focus more on interventions targeting both diet and physical activity while also promoting positive body image",
"OBJECTIVE Examine bidirectional associations between weight perception and weight change over time among adults . METHODS Data are from adult employees ( N = 623 ) across 12 U.S. public high schools participating in a cluster-r and omized multilevel weight gain prevention intervention . Data were collected at baseline , 12 months , and 24 months . Perceived weight status ( very/somewhat underweight , just right , somewhat overweight , very overweight ) were obtained via self-administered surveys . Weight ( kg ) was measured by trained staff . Change in weight was calculated as the difference between baseline weight and weight at each follow-up time point . Structural equation models were used to assess bidirectional associations of perceived weight status and change in weight over time . Models were adjusted for study condition , gender , age , race/ethnicity , education level , and previous time point . RESULTS The sample was 65 % female with a mean age of 44.6 ( SD = 11.3 ) . Nearly two thirds of the sample consisted of people with overweight ( 38.8 % ) or obesity ( 27.3 % ) . Structural equation models indicated that baseline weight predicted subsequent perceived weight status ( β = 0.26 ; P baseline perceived weight status did not predict subsequent change in weight , adjusting for previous time point and covariates . CONCLUSIONS Results do not support bidirectional causality between weight perception and weight change in an adult sample"
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Purpose The purpose of the study is to determine the effectiveness of semi-active and active robotic hip and knee arthroplasty on post-operative patient-reported outcomes of function , pain , quality of life and satisfaction with surgery . Methods PubMed , Medline , Embase and CENTRAL were search ed . Included were comparative studies investigating the effectiveness of semi-active or active robotic hip or knee arthroplasty compared to any other surgical intervention on function , pain , quality of life and satisfaction with surgery . Risk of bias and the strength of the evidence were assessed using the Downs and Black tool and the GRADE system , respectively . Relative risks , mean differences and 95 % CI were calculated using r and om-effects models . Results Fourteen studies involving 1342 patients were included . All studies compared robotic to conventional surgery , with active robotic surgery evaluated in total hip or knee arthroplasty and semi-active robotic surgery in total hip or unicompartmental knee arthroplasty . Most studies presented some risk of bias , and the strength of evidence was rated as low to very low quality . R and om-effects meta-analyses showed that post-operative functional outcomes were comparable between active robotic and conventional total hip and knee arthroplasty at the short- , medium- and long-term follow-up . No significant difference in pain , quality of life and satisfaction with surgery were reported in individual studies . Conclusions This systematic and meta-analyses indicates that functional outcomes for patients undergoing active robotic total hip and knee arthroplasty were comparable to conventional surgery . Whether semi-active or active robotic hip or knee arthroplasty is effective in improving post-operative pain , quality of life and satisfaction with surgery is unclear . PROSPERO Registration Number : CRD42017059932
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"This study was aim ed to compare robotic-assisted implantation of a total knee arthroplasty with conventional manual implantation . We controlled , r and omized , and review ed 72 patients for total knee arthroplasty assigned to undergo either conventional manual implantation ( excluding navigation-assisted implantation cases ) of a Zimmer LPS prosthesis ( Zimmer , Warsaw , Ind ) ( 30 patients : group 1 ) or robotic-assisted implantation of such a prosthesis ( 32 patients : group 2 ) . The femoral flexion angle ( gamma angle ) and tibial angle ( delta angle ) in the lateral x-ray of group 1 were 4.19 + /- 3.28 degrees and 89.7 + /- 1.7 degrees , and those of group 2 were 0.17 + /- 0.65 degrees and 85.5 + /- 0.92 degrees . The major complications were from improper small skin incision during a constraint attempt of minimally invasive surgery and during bulk fixation frame pins insertion . Robotic-assisted technology had definite advantages in terms of preoperative planning , accuracy of the intraoperative procedure , and postoperative follow-up , especially in the femoral flexion angle ( gamma angle ) and tibial flexion angle ( delta angle ) in the lateral x-ray , and in the femoral flexion angle ( alpha angle ) in the anteroposterior x-ray . But a disadvantage was the high complication rate in early stage",
"Background The benefits of robotic techniques for implanting femoral components during THA are still controversial . Questions / Purpose sThe purpose of this study was to prospect ively compare the results and complications of robotic-assisted and h and -rasping stem implantation techniques . Method The minimum followup was 5 years ( mean , 67 months ; range , 60–85 months ) . One hundred forty-six primary THAs on 130 patients were included in this study . Robot-assisted primary THA was performed on 75 hips and a h and -rasping technique was used on 71 hips . Results At 2 and 3 years postoperatively , the Japanese Orthopaedic Association ( JOA ) clinical score was slightly better in the robotic-assisted group . At 5 years followup , however , the differences were not significant . Postoperative limb lengths of the robotic-milling group had significantly less variance than the h and -rasping group . At 2 years postoperatively , there was significantly more stress shielding of the proximal femur in the h and -rasping group ; this difference was more significant 5 years postoperatively . Conclusions Substantially more precise implant positioning seems to have led to less variance in limb-length ine quality and less stress shielding of the proximal femur 5 years postoperatively . Level of Evidence Level II , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"The ROBODOC ® system was design ed to address potential human errors in performing cementless total hip replacement . The system consists of a preoperative planning computer workstation ( called ORTHODOC ) and a five-axis robotic arm with a high speed milling device as an end effector . The combined experience of the United States Food and Drug Administration multicenter trial and the German postmarket use of the system are reported . The United States study is controlled and r and omized with 136 hip replacements performed at three centers ( 65 ROBODOC ® and 62 control ) . Followup was 1 year on 127 hip replacements and 2 years on 93 hip replacements . No differences were found in the Harris hip scores or the Short Form Health Survey outcomes question naire . Length of stay also was not different , but the surgical time and blood loss were greater in the ROBODOC ® group . This was attributed to a learning curve at each center . Radiographs were evaluated by an independent bone radiologist and showed statistically better fit and positioning of the femoral component in the ROBODOC ® group . Complications were not different , except for three cases of intraoperative femoral fracture in the control group and none in the ROBODOC ® group . The German study reports on 858 patients , 42 with bilateral hip replacements and this includes 30 revision cases for a total of 900 hip replacements . The Harris hip score rose from 43.7 to 91.5 . In these cases the surgical time declined quickly from 240 minutes for the first case to 90 minutes . No intraoperative femoral fractures occurred in 900 cases . Other complications were comparable with total hip replacements performed using conventional techniques . The ROBODOC ® system is thought to be safe and effective in producing radiographically superior implant fit and positioning while eliminating femoral fractures",
"AIM Robotic assisted total hip arthroplasty remains controversial , since wider exposure of the proximal femur and placement of the leg in maximal hip adduction and external rotation using a rigid leg-holder apparatus may impair significantly the hip abductors . Consequently , it is the purpose of this study to analyse and report both clinical outcome and hip abductor function following robotic assisted versus conventional total hip arthroplasty . MATERIAL AND METHODS 36 robotic-assisted ( CASPAR , Orto-Maquet , Rastatt , Germany ) and 35 conventional cementless total hip arthroplasties were followed on average for 18 months regarding incidence of complications , Harris hip score , the scoring system according to Merle d'Aubigné and Postel , hip abductor function ( using a spring-balance ) , and incidence of Trendelenburg 's sign ( according to the Kuhfuss-classification ) . Statistical analysis was performed in case of continuous data using the t test and the Mann-Whitney test , respectively , and in case of categorical data using Fisher 's exact test and the chi-squared test , respectively . The level of significance was set as p Average duration of surgery ( CASPAR : 100.6 min ; conventional : 51.5 min ; p average loss of haemoglobin ( CASPAR : 4.5 mg/dL ; conventional : 3.3 mg/dL ; p = 0.0002 ) differed significantly , whereas the incidence of complications ( CASPAR : two dislocations , one sciatic paresis , one deep infection ; conventional : one dislocation , two fissures ) , revision rate ( CASPAR : 5.6 % ; conventional : 2.9 % ) , and incidence of heterotopic ossifications ( CASPAR : 30.6 % ; conventional : 17.1 % ) was comparable following both procedures ( p > 0.05 ) . Improvement of the Harris hip score also was comparable in both groups ( CASPAR : 40.9 to 86.1 points ; conventional : 39.5 to 88.0 points ; p = 0.21 ) , whereas improvement of the score according to Merle d'Aubigné and Postel was significantly greater following the manual procedure ( CASPAR : 10.1 to 16.0 points ; conventional : 8.3 to 16.6 points ; p regarding hip abductor function ( CASPAR : 76.1 % ; conventional : 93.8 % of the contralateral hip ; p incidence of Trendelenburg 's sign ( CASPAR : 61.1 % ; conventional : 25.7 % ; p = 0.0014 ) . CONCLUSION The significant functional impairment following robotic assisted THA should be taken critically into consideration prior to initiating such procedure",
"Purpose Despite reduction in radiological outliers in previous r and omized trials comparing robotic-assisted versus conventional total knee arthroplasty ( TKA ) , no differences in short-term functional outcomes were observed . The aim of this study was to determine whether there was improvement in functional outcomes and quality -of-life ( QoL ) measures between robotic-assisted and conventional TKA . Methods All 60 knees ( 31 robotic-assisted ; 29 conventional ) from a previous r and omized trial were available for analysis . Differences in range of motion , Knee Society ( KSS ) knee and function scores , Oxford Knee scores ( OKS ) , SF-36 subscale and summative ( physical PCS/mental component scores MCS ) were analysed . In addition , patient satisfaction , fulfilment of expectations and the proportion attaining a minimum clinical ly important difference ( MCID ) in KSS , OKS and SF-36 were studied . Results Both robotic-assisted and conventional TKA displayed significant improvements in majority of the functional outcome scores at 2 years . Despite having a higher rate of complications , the robotic-assisted group displayed a trend towards higher scores in SF-36 QoL measures , with significant differences in SF-36 vitality ( p = 0.03 ) , role emotional ( p = 0.02 ) and a larger proportion of patients achieving SF-36 vitality MCID ( 48.4 vs 13.8 % , p = 0.009 ) . No significant differences in KSS , OKS or satisfaction/expectation rates were noted . ConclusionS ubtle improvements in patient QoL measures were observed in robotic-assisted TKA when compared to conventional TKA . This finding suggests that QoL measures may be more sensitive and clinical ly important than surgeon-driven objective scores in detecting subtle functional improvements in robotic-assisted TKA patients .Level of evidence II",
"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",
"Background Several studies have shown mechanical alignment influences the outcome of TKA . Robotic systems have been developed to improve the precision and accuracy of achieving component position and mechanical alignment . Questions / purpose sWe determined whether robotic-assisted implantation for TKA ( 1 ) improved clinical outcome ; ( 2 ) improved mechanical axis alignment and implant inclination in the coronal and sagittal planes ; ( 3 ) improved the balance ( flexion and extension gaps ) ; and ( 4 ) reduced complications , postoperative drainage , and operative time when compared to conventionally implanted TKA over an intermediate-term ( minimum 3-year ) followup period . Methods We prospect ively r and omized 100 patients who underwent unilateral TKA into one of two groups : 50 using a robotic-assisted procedure and 50 using conventional manual techniques . Outcome variables considered were postoperative ROM , WOMAC scores , Hospital for Special Surgery ( HSS ) knee scores , mechanical axis alignment , flexion/extension gap balance , complications , postoperative drainage , and operative time . Minimum followup was 41 months ( mean , 65 months ; range , 41–81 months ) . Results There were no differences in postoperative ROM , WOMAC scores , and HSS knee scores . The robotic-assisted group result ed in no mechanical axis outliers ( > ± 3 ° from neutral ) compared to 24 % in the conventional group . There were fewer robotic-assisted knees where the flexion gap exceeded the extension gap by 2 mm . The robotic-assisted procedures took an average of 25 minutes longer than the conventional procedures but had less postoperative blood drainage . There were no differences in complications between groups . Conclusions Robotic-assisted TKA appears to reduce the number of mechanical axis alignment outliers and improve the ability to achieve flexion-extension gap balance , without any differences in clinical scores or complications when compared to conventional manual techniques . Level of Evidence Level I , therapeutic study . See Instructions for Authors for a complete description of levels of evidence",
"Background : The aim of this study was to vali date the Knee Society Clinical Rating System ( knee and function scores ) and to compare its responsiveness with that of the Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) and the Medical Outcomes Study Short Form-36 ( SF-36 ) . Methods : Patients were recruited as part of a prospect i ve observational study of the outcomes of primary total knee arthroplasty for the treatment of osteoarthritis in four centers in the United States , six centers in the United Kingdom , and two centers in Australia . Independent research assistants at each site collected the Knee Society clinical data . The WOMAC , SF-36 , patient satisfaction , and demographic data were obtained with self-administered question naires . Results : A total of 862 eligible patients were recruited , and complete preoperative and twelve-month data were available for 697 ( 80.9 % ) of them . The mean age was seventy years ( range , thirty-eight to ninety years ) , and the majority of the patients ( 58.9 % ) were women . Low correlations were found among the items of both the knee and the function score at both assessment times . The Knee Society pain and function scores had moderate-to-strong correlations with the corresponding pain and function domains of the WOMAC and SF-36 ( r = 0.31 to 0.72 ) . Measurement of the st and ardized response mean showed the Knee Society knee score to be more responsive ( st and ardized response mean , 2.2 ) than the WOMAC ( st and ardized response means , 2.0 for pain and 1.4 for function ) and the SF-36 ( st and ardized response means , 1.0 for bodily pain and 1.1 for physical functioning ) . The Knee Society function score was the least responsive measure ( st and ardized response mean , 0.8 ) . Correlation of changes in scores at twelve months with patient reports of satisfaction and improvement in health status showed the WOMAC and SF-36 to be more responsive than the Knee Society scores . Conclusions : There is a poor correlation among the items of the Knee Society Clinical Rating System , but the rating system has adequate convergent construct validity . The WOMAC and SF-36 are more responsive measures of outcome of total knee arthroplasty . As they are less labor-intensive for research ers to use and as use of these instruments removes observer bias from the study design , they are preferable for knee arthroplasty outcome studies",
"BACKGROUND Robotic-assisted total hip replacement has become a common method of implantation , especially in Europe . It frequently has been postulated that robotic reaming would result in an improved clinical outcome due to the better fit of the prosthesis , but that has never been demonstrated in a prospect i ve study , to our knowledge . The purpose of this study was to compare robotic-assisted implantation of a total hip replacement with conventional manual implantation . METHODS One hundred and fifty-four patients scheduled for total hip replacement were r and omly assigned to undergo either conventional manual implantation of an S-ROM prosthesis ( eighty patients ) or robotic-assisted implantation of such a prosthesis ( seventy-four patients ) . The five-axis ROBODOC was used for the robotic-assisted procedures . Preoperatively as well as at three , six , twelve , and twenty-four months after surgery , the scores according to the Harris and Merle d'Aubigné systems and the Mayo clinical score were determined . Radiographs made at these intervals were analyzed for evidence of loosening , prosthetic alignment , and heterotopic ossification . RESULTS Thirteen ( 18 % ) of the seventy-four attempted robotic implantations had to be converted to manual implantations as a result of failure of the system . The duration of the robotic procedures was longer than that of the manual procedures ( mean and st and ard deviation,107.1 + /- 29.1 compared with 82.4 + /- 23.4 minutes , p Limb-length e quality ( mean discrepancy , 0.18 + /- 0.30 compared with 0.96 + /- 0.93 cm , p varus-valgus orientation of the stem ( mean angle between the femur and the shaft of the prosthesis , 0.34 degrees + /- 0.67 degrees compared with 0.84 degrees + /- 1.23 degrees , p robotic procedures . At six months , slightly more heterotopic ossification was seen in the group treated with robotic implantation . The group treated with robotic implantation had a better Mayo clinical score at six and twelve months and a better Harris score at twelve months ; however , by twenty-four months , no difference was found between the groups with regard to any of the three scores . Dislocation was more frequent in the group treated with robotic implantation : it occurred in eleven of the sixty-one patients in that group compared with three of eighty in the other group ( p . Recurrent dislocation and pronounced limping were indications for revision surgery in eight of the sixty-one patients treated with robotic implantation compared with none of the seventy-eight ( excluding two with revision for infection ) treated with manual insertion ( p Rupture of the gluteus medius tendon was observed during all of the revision operations . CONCLUSIONS The robotic-assisted technology had advantages in terms of preoperative planning and the accuracy of the intraoperative procedure . Disadvantages were the high revision rate ; the amount of muscle damage , which we believe was responsible for the higher dislocation rate ; and the longer duration of surgery . This technology must be further developed before its widespread usage can be justified",
"BACKGROUND Recently , two topical issues in total hip arthroplasty ( THA ) have been robot-assisted surgery and use of a short stem . The purpose of this study was to evaluate the effects of robotic milling on the accuracy of short femoral stem positioning and on the short-term clinical outcome in THA using a prospect i ve , r and omized design . METHODS We r and omized 54 patients into two groups , either robotic milling group or manual rasping group . The patients were assessed clinical ly and radiographically at 8 weeks , 5 months , 12 months , and 24 months . RESULTS Robotic milling group had a significantly longer operation time , requiring on average 8.9 min for registration and 11.2 min for milling . On the other h and , robotic milling group showed superior results in terms of stem alignment and leg length e quality . Two intraoperative femoral fractures occurred only in manual rasping group . Harris hip scores and WOMAC scores at 24 months postoperatively were similar in both groups . No complications including stem loosening , infection , nerve palsy , or dislocation were encountered in either group during the follow-up period . CONCLUSIONS The present study suggested that robot-assisted short stem THA could increase the accuracy of stem alignment , improve leg length e quality , and help reduce the risk of intraoperative femoral fracture as compared with manual rasping . However , the clinical outcome scores did not differ between the two groups at the time of short-term follow-up . Long-term follow-up is needed to determine whether there will be a long-term clinical relevance of robot-assisted implantation of short femoral stems in THA"
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4117253a-06ff-11f0-808a-c43d1ab1c353
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Modern TKR prostheses are design ed to restore healthy kinematics including high flexion . Kneeling is a dem and ing high-flexion activity . There have been many studies of kneeling kinematics using a plethora of implant design s but no comprehensive comparisons . Visualisation of contact patterns allows for quantification and comparison of knee kinematics . The aim of this systematic review was to determine whether there are any differences in the kinematics of kneeling as a function of TKR design . A search of the published literature identified 26 articles which were assessed for method ologic quality using the MINORS instrument . Contact patterns for different implant design s were compared at 90 ° and maximal flexion using quality -effects meta- analysis models . Twenty-five different implants using six design s were reported . Most of the included studies had small- sample sizes , were non-consecutive , and did not have a direct comparison group . Only posterior-stabilised fixed-bearing and cruciate-retaining fixed-bearing design s had data for more than 200 participants . Meta-analyses revealed that bicruciate-stabilised fixed-bearing design s appeared to achieve more flexion and the cruciate-retaining rotating-platform design achieved the least , but both included single studies only . All design s demonstrated posterior – femoral translation and external rotation in kneeling , but posterior-stabilised design s were more posterior at maximal flexion when compared to cruciate retaining . However , the heterogeneity of the mean estimates was substantial , and therefore , firm conclusions about relative behaviour can not be drawn . The high heterogeneity may be due to a combination of variability in the kneeling activity and variations in implant geometry within each design category . There remains a need for a high- quality prospect i ve comparative studies to directly compare design s using a common method . Systematic review and meta- analysis Level
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[
"The goal of this prospect i ve , r and omized , blinded trial was to determine if ligament balancing techniques for rotating platform TKA affect postoperative knee kinematics . Sixteen patients with unilateral rotating platform TKA consented to participate in this institutional review board approved study . Eight patients were r and omly selected to receive ligament balancing with an instrumented joint spreader device and eight patients received ligament balancing using fixed thickness spacer blocks . A single plane shape matching technique was used for kinematic analysis of static deep knee flexion and dynamic stair activities . There were no differences in knee kinematics between groups during static deep flexion activities . The spreader group demonstrated kinematics more similar to the normal knee during the ascending phase of the dynamic stair activity . Knee kinematics in static knee flexion were unaffected by ligament balancing technique , while knees balanced with the spreader demonstrated a medial pivot motion pattern during stair ascent . This medial pivot motion pattern may improve long-term results by more closely replicating normal knee kinematics",
"Purpose Tibiofemoral contact kinematics or knee implant motions have a direct influence on patient function and implant longevity and should be evaluated for any new alignment technique such as kinematically aligned total knee arthroplasty ( TKA ) . Edge loading of the tibial liner and external rotation ( reverse of normal ) and adduction of the tibial component on the femoral component are undesirable contact kinematics that should be minimized . Accordingly , this study determined whether the overall prevalence of undesirable contact kinematics during st and ing , mid kneeling near 90 degrees and full kneeling with kinematically aligned TKA are minimal and not different between groups of consecutive patients treated by different surgeons . Methods Three surgeons were asked to perform cemented , kinematically aligned TKA with patient-specific guides in a consecutive series of patients with their preferred cruciate-retaining ( CR ) implant . In vivo tibiofemoral contact positions were obtained using a 3- to 2-dimensional image registration technique in 69 subjects ( Vanguard CR – TKA N = 22 , and Triathlon CR – TKA N = 47 ) . Results Anterior or posterior edge loading of the tibial liner was not observed . The overall prevalence of external rotation of the tibial component on the femoral component of 6 % was low and not different between surgeons ( n.s . ) . The overall prevalence of adduction of the tibial component on the femoral component of 4 % was low and not different between surgeons ( n.s . ) . Conclusions Kinematically aligned TKA minimized the undesirable contact kinematics of edge loading of the tibial liner , and external rotation and adduction of the tibial component on the femoral component during st and ing and kneeling , which suggests an optimistic prognosis for durable long-term function . Level of evidence III",
"Background Kneeling is one of the activities sought by patients after total knee arthroplasty ( TKA ) . This study investigated the six degrees of freedom ( DOF ) kinematics and three-dimensional ( 3D ) contact during weight-bearing kneeling . Methods A total of 16 South Korean female patients ( 22 knees ) after posteriorly stabilized ( PS ) TKA ( LPS-Flex ) were r and omly recruited and had the same surgeon . The patients were imaged using a dual fluoroscopic technique while they kneeled from initial to maximum flexion . The acquired images and 3D models were then used to recreate the in vivo pose of the components . Contact was determined by locating the surface intersections in the tibiofemoral and cam/post ( between the femoral cam and tibial post ) articular compartments . Results Patients flexed , on average , from 107.3 ° to 128.0 ° during the kneeling activity . Changes in kinematics included 1.0 mm of proximal , 0.9 mm of medial , and 7.6 mm of posterior translation and 1.7 ° of varus rotation ( P difference in internal tibial rotation was not detected . Articular contact moved posteriorly by 5.9 mm and 6.4 mm in the medial and lateral compartments , respectively . Contact also moved medially by 3.2 mm and 5.8 mm in the medial and lateral compartments . A decrease in articular contact was observed in both condyles , and lateral condylar lift-off increased with flexion ( P = 0.0001 ) . More than 80 % of the patients demonstrated cam/post engagement , which always occurred in the distal portion of the post . Conclusions In this patient cohort , the knee joint was constrained during the weight-bearing activity such that femoral subluxation and dislocation were not observed . Furthermore , posterior cam/post engagement occurred only in the distal portion of the tibial post , which may improve the longevity of the post . The tibiofemoral and cam/post articular contact data presented in this study further suggest that kneeling may be performed by patients after clinical ly successful PS TKA who feel comfortable with the activity and are free of pain",
"BACKGROUND The reasons why surgeons prefer a particular total knee replacement ( TKR ) to other viable options with lower cost or lower revision risk remain uncertain . This study examined the concept of surgeon 's preference in TKR ; including the self-assigned utility of their preferred prosthesis , reasons to alter usual preference and barriers to permanently changing preference . METHODS Using a multinational electronic survey , 347 TKR performing orthopedic surgeons were studied using anonymous m and atory responses , mutually exclusive closed options , multiple responses blocking , automatic stem r and omization , Likert scale weighting , and an absence of neutral options . RESULTS The highest rated of the 17 attributes were \" reproducibility of outcome , \" \" best functional outcome , \" and \" better kinematics . \" The lowest rated were a \" key-opinion leader or mentor uses it \" and \" new or innovative . \" \" Lowest revision risk \" ranked 10th , with 19.9 % of surgeons stating it did not influence their preference . Cost did not influence 52.1 % of surgeons and 33.7 % agreed that their institution or system limited their preference . Surgeon 's demographics and preferred prosthesis or technique altered some attribute ratings including surgical volume , country of practice , type of preferred implant ; however , revision risk rating was not altered by any factor . Cost considerations altered rating of barriers to technique change . CONCLUSION Underst and ing why surgeons prefer certain TKR prostheses or techniques to other viable alternatives is vital to reduce unwarranted variation . This study suggests that the self-assigned reasons driving surgeon 's preferences , reasons for preference alteration , and barriers to change are multifactorial , diverse , and complex , with revision risk not being the highest rated attribute",
"BACKGROUND Posterior-cruciate ligament retaining total knee arthroplasty design s have long been used with excellent clinical success , but often have shown kinematics and flexion performance that are significantly different from the natural knee . The purpose of this study was to compare deep-flexion knee kinematics in patients with two types of posterior-cruciate ligament retaining total knee arthroplasty . METHODS One group received a traditional curved symmetric articular configuration , and one group received a design incorporating a lateral compartment which constrains the lateral condyle to the antero-posterior center of the tibial plateau in extension , but allows translation in flexion -- roughly approximating the role of the anterior cruciate ligament . In vivo kinematics were analyzed using three-dimensional model registration and plain radiographs of kneeling and squatting activities in 20 knees in 18 patients . FINDINGS Knees with the anterior cruciate ligament substituting design exhibited greater flexion , femoral antero-posterior translation and tibial internal rotation . INTERPRETATION Geometric features intended to improve knee flexion , including greater antero-posterior stability , a more posterior tibial sulcus , and reshaped femoral condyles , do provide measurable and significant differences in deep-flexion knee kinematics",
"Patient expectations and their fulfilment are an important factor in determining patient-reported outcome and satisfaction of hip ( THR ) and knee replacement ( TKR ) . The aim of this prospect i ve cohort study was to examine the expectations of patients undergoing THR and TKR , and to identify differences in expectations , predictors of high expectations and the relationship between the fulfilment of expectations and patient-reported outcome measures . During the study period , patients who underwent 346 THRs and 323 TKRs completed an expectation question naire , Oxford score and Short-Form 12 ( SF-12 ) score pre-operatively . At one year post-operatively , the Oxford score , SF-12 , patient satisfaction and expectation fulfilment were assessed . Univariable and multivariable analysis were performed . Improvements in mobility and daytime pain were the most important expectations in both groups . Expectation level did not differ between THR and TKR . Poor Oxford score , younger age and male gender significantly predicted high pre-operative expectations ( p level of pre-operative expectation was not significantly associated with the fulfilment of expectations or outcome . THR better met the expectations identified as important by patients . TKR failed to meet expectations of kneeling , squatting and stair climbing . High fulfilment of expectation in both THR and TKR was significantly predicted by young age , greater improvements in Oxford score and high pre-operative mental health scores . The fulfilment of expectations was highly correlated with satisfaction",
"Background : Because of specific method ological difficulties in conducting r and omized trials , surgical research remains dependent predominantly on observational or non‐r and omized studies . Few vali date d instruments are available to determine the method ological quality of such studies either from the reader 's perspective or for the purpose of meta‐ analysis . The aim of the present study was to develop and vali date such an instrument",
"BACKGROUND Articular geometry of knee implant has a competing impact on kinematics and contact mechanics of total knee arthroplasty ( TKA ) such that geometry with lower contact pressure will impose more constraints on knee kinematics . The geometric parameters that may cause this competing effect have not been well understood . This study aim ed to quantify the underlying relationships between implant geometry as input and its performance metrics as output . METHODS Parametric dimensions of a fixed-bearing cruciate retaining implant were r and omized to generate a number of perturbed implant geometries . Performance metrics ( i.e. , maximum contact pressure , anterior-posterior range of motion [ A-P ROM ] and internal-external range of motion [ I-E ROM ] ) of each r and omized design were calculated using finite element analysis . The relative contributions of individual geometric variables to the performance metrics were then determined in terms of sensitivity indices ( SI ) . RESULTS The femoral and tibial distal or posterior radii and femoral frontal radius are the key parameters . In the sagittal plane , distal curvature of the femoral and tibial influenced both contact pressure , i.e. , SI=0.57 ; SI=0.65 , and A-P ROM , i.e. , SI=0.58 ; SI=0.6 , respectively . However , posterior curvature of the femoral and tibial implants had a smaller impact on the contact pressure , i.e. , SI=0.31 ; SI=0.23 and a higher impact on the I-E ROM , i.e. , SI=0.72 ; SI=0.58 . It is noteworthy that in the frontal plane , frontal radius of the femoral implant impacted both contact pressure ( SI=0.38 ) and I-E ROM ( SI=0.35 ) . CONCLUSION Findings of this study highlighted how changes in the conformity of the femoral and tibial can impact the performance metrics"
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41172576-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Frailty is a geriatric syndrome characterized by the clinical presentation of identifiable physical alterations and decreased physiological reserve . The assessment of frailty syndrome has been recently related with post-surgical outcomes and overall mortality in older individuals . DESIGN AND DATA SOURCES We performed search es in Pubmed , Embase , Scopus , SCIELO and IME ( Spanish medical index ) data bases from their start date s to February 2014 for original papers about the identification of the relationship between frailty and pre-operative risk evaluation in people aged 65 and over . REVIEW METHODS We followed criteria of systematic PRISMA guidelines . Two independent review ers extracted descriptive information on frailty criteria and outcomes from the selected papers : of the 77 articles retrieved from the search es , 32 met the study inclusion criteria . RESULTS Severity of frailty syndrome significantly correlated with post-surgical mortality rates and with many although not all post-surgical complications . These relationships emerge in different type of surgical procedures and patients ' features . The comparison of diagnostic tools to assess frailty in pre-operative risk evaluation are very few and to date , no recommendation can be made about the best scale to measure it . CONCLUSION Assessment of frailty syndrome should be added in the pre-operative risk assessment in older individuals
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"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 Selecting elderly persons who need geriatric interventions and making accurate treatment decisions are recurring challenges in geriatrics . Chronological age , although often used , does not seem to be the best selection criterion . Instead , the concept of frailty , which indicates several concurrent losses in re sources , can be used . METHODS The predictive values of chronological age and frailty were investigated in a large community sample of persons aged 65 years and older , r and omly drawn from the register of six municipalities in the northern regions of the Netherl and s ( 45 % of the original addressees ) . The participants ' generative capacity to sustain well-being ( i.e. , self-management abilities ) was used as the main outcome measure . RESULTS When using chronological age instead of frailty , both too many and too few persons were selected . Furthermore , frailty related more strongly ( with beta values ranging from -.25 to -.39 ) to a decline in the participants ' self-management abilities than did chronological age ( with beta values ranging from -.06 to -.14 ) . Chronological age added very little to the explained variances of all outcomes once frailty was included . CONCLUSIONS Using frailty as the criterion to select older persons at risk for interventions may be better than selecting persons based only on their chronological age",
"BACKGROUND The decision as to whether a patient can tolerate surgery is often subjective and can misjudge a patient 's true physiologic state . The concept of frailty is an important assessment tool in the geriatric medical population , but has only recently gained attention in surgical patients . Frailty potentially represents a measureable phenotype , which , if quantified with a st and ardized protocol , could reliably estimate the risk of adverse surgical outcomes . STUDY DESIGN Frailty was prospect ively evaluated in the clinic setting in patients consenting for major general , oncologic , and urologic procedures . Evaluation included an established assessment tool ( Hopkins Frailty Score ) , self-administered question naires , clinical assessment of performance status , and biochemical measures . Primary outcome was 30-day postoperative complications . RESULTS There were 189 patients evaluated : 117 from urology , 52 from surgical oncology , and 20 from general surgery clinics . Mean age was 62 years , 59.8 % were male , and 71.4 % were Caucasian . Patients who scored intermediately frail or frail on the Hopkins Frailty Score were more likely to experience postoperative complications ( odds ratio [ OR ] 2.07 , 95 % CI 1.05 to 4.08 , p = 0.036 ) . Of all other preoperative assessment tools , only higher hemoglobin ( p = 0.033 ) had a significant association and was protective for 30-day complications . CONCLUSIONS The aggregate score of patients as \" intermediately frail or frail \" on the Hopkins Frailty Score was predictive of a patient experiencing a postoperative complication . This preoperative assessment tool may prove beneficial when weighing the risks and benefits of surgery , allowing objective data to guide surgical decision-making and patient counseling",
"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 Preoperative risk assessment is important yet inexact in older patients because physiologic reserves are difficult to measure . Frailty is thought to estimate physiologic reserves , although its use has not been evaluated in surgical patients . We design ed a study to determine if frailty predicts surgical complications and enhances current perioperative risk models . STUDY DESIGN We prospect ively measured frailty in 594 patients ( age 65 years or older ) presenting to a university hospital for elective surgery between July 2005 and July 2006 . Frailty was classified using a vali date d scale ( 0 to 5 ) that included weakness , weight loss , exhaustion , low physical activity , and slowed walking speed . Patients scoring 4 to 5 were classified as frail , 2 to 3 were intermediately frail , and 0 to 1 were nonfrail . Main outcomes measures were 30-day surgical complications , length of stay , and discharge disposition . Multiple logistic regression ( complications and discharge ) and negative binomial regression ( length of stay ) were done to analyze frailty and postoperative outcomes associations . RESULTS Preoperative frailty was associated with an increased risk for postoperative complications ( intermediately frail : odds ratio [ OR ] 2.06 ; 95 % CI 1.18 - 3.60 ; frail : OR 2.54 ; 95 % CI 1.12 - 5.77 ) , length of stay ( intermediately frail : incidence rate ratio 1.49 ; 95 % CI 1.24 - 1.80 ; frail : incidence rate ratio 1.69 ; 95 % CI 1.28 - 2.23 ) , and discharge to a skilled or assisted-living facility after previously living at home ( intermediately frail : OR 3.16 ; 95 % CI 1.0 - 9.99 ; frail : OR 20.48 ; 95 % CI 5.54 - 75.68 ) . Frailty improved predictive power ( p risk index ( ie , American Society of Anesthesiologists , Lee , and Eagle scores ) . CONCLUSIONS Frailty independently predicts postoperative complications , length of stay , and discharge to a skilled or assisted-living facility in older surgical patients and enhances conventional risk models . Assessing frailty using a st and ardized definition can help patients and physicians make more informed decisions",
"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",
"OBJECTIVES To determine the independent prognostic effect of seven potential frailty criteria , including five from the Fried phenotype , on several adverse outcomes . DESIGN Prospect i ve cohort study . SETTING Greater New Haven , Connecticut . PARTICIPANTS Seven hundred fifty-four initially nondisabled , community-living persons aged 70 and older . MEASUREMENTS An assessment of seven potential frailty criteria ( slow gait speed , low physical activity , weight loss , exhaustion , weakness , cognitive impairment , and depressive symptoms ) was completed at baseline and every 18 months for 72 months . Participants were followed with monthly telephone interviews for up to 96 months to determine the occurrence of chronic disability , long-term nursing home ( NH ) stays , injurious falls , and death . RESULTS In analyses adjusted for age , sex , race , education , number of chronic conditions , and the presence of the other potential frailty criteria , three of the five Fried criteria ( slow gait speed , low physical activity , and weight loss ) were independently associated with chronic disability , long-term NH stays , and death . Slow gait speed was the strongest predictor of chronic disability ( hazard ratio (HR)=2.97 , 95 % confidence interval (CI)=2.32 - 3.80 ) and long-term NH stay ( HR=3.86 , 95 % CI=2.23 - 6.67 ) and was the only significant predictor of injurious falls ( HR=2.19 , 95 % CI=1.33 - 3.60 ) . Cognitive impairment was also associated with chronic disability ( HR=1.82 , 95 % CI=1.40 - 2.38 ) , long-term NH stay ( HR=2.64 , 95 % CI=1.75 - 3.99 ) , and death ( HR=1.54 , 95 % CI=1.13 - 2.10 ) , and the magnitude of these associations was comparable with that of weight loss . CONCLUSION The results of this study provide strong evidence to support the use of slow gait speed , low physical activity , weight loss , and cognitive impairment as key indicators of frailty while raising concerns about the value of self-reported exhaustion and muscle weakness",
"OBJECTIVE To develop and vali date a new st and ardized confusion assessment method ( CAM ) that enables nonpsychiatric clinicians to detect delirium quickly in high-risk setting s. DESIGN Prospect i ve validation study . SETTING Conducted in general medicine wards and in an outpatient geriatric assessment center at Yale University ( site 1 ) and in general medicine wards at the University of Chicago ( site 2 ) . PATIENTS The study included 56 subjects , ranging in age from 65 to 98 years . At site 1 , 10 patients with and 20 without delirium participated ; at site 2 , 16 patients with and 10 without delirium participated . MEASUREMENTS AND MAIN RESULTS An expert panel developed the CAM through a consensus building process . The CAM instrument , which can be completed in less than 5 minutes , consists of nine operationalized criteria from the Diagnostic and Statistical Manual of Mental Disorders ( DSM-III-R ) . An a priori hypothesis was established for the diagnostic value of four criteria : acute onset and fluctuating course , inattention , disorganized thinking , and altered level of consciousness . The CAM algorithm for diagnosis of delirium required the presence of both the first and the second criteria and of either the third or the fourth criterion . At both sites , the diagnoses made by the CAM were concurrently vali date d against the diagnoses made by psychiatrists . At sites 1 and 2 values for sensitivity were 100 % and 94 % , respectively ; values for specificity were 95 % and 90 % ; values for positive predictive accuracy were 91 % and 94 % ; and values for negative predictive accuracy were 100 % and 90 % . The CAM algorithm had the highest predictive accuracy for all possible combinations of the nine features of delirium . The CAM was shown to have convergent agreement with four other mental status tests , including the Mini-Mental State Examination . The interobserver reliability of the CAM was high ( kappa = 0.81 - 1.0 ) . CONCLUSIONS The CAM is sensitive , specific , reliable , and easy to use for identification of delirium",
"OBJECTIVES To construct and vali date a frailty index ( FI ) that is clinical ly sensible and practical for geriatricians by basing it on a routinely used comprehensive geriatric assessment ( CGA ) instrument . DESIGN Secondary analysis of a 3-month r and omized , controlled trial of a specialized mobile geriatric assessment team . SETTING Rural Nova Scotia . Participants were seen in their homes . PARTICIPANTS Frail older adults , of whom 92 were in the intervention group and 77 in the control group . MEASUREMENTS A st and ard CGA form that accounts for impairment , disability , and comorbidity burden was scored and summed as a frailty index ( FI-CGA ) . The FI-GCA was stratified to describe three levels of frailty . Patients were followed for up to 12 months to determine how well the index predicted adverse outcomes ( institutionalization or mortality , whichever came first ) . RESULTS The three levels of frailty were mild ( FI-CGA 0 - 7 ) , moderate ( FI-CGA 7 - 13 ) , and severe ( FI-CGA>13 ) . Demographic and social traits were similar across groups , but greater frailty was associated with worse function ( r=0.55 ) and mental status ( r=0.33 ) . Those with moderate and severe frailty had a greater risk of adverse outcomes than those with mild frailty ( unadjusted hazard ratio=1.9 and 5.5 , respectively ) . There was no difference between frailty groups in mean 3-month goal -attainment scaling scores . Intrarater reliability was 0.95 . CONCLUSION The FI-CGA is a valid , reliable , and sensible clinical measure of frailty that permits risk stratification of future adverse outcomes",
"Introduction Following trauma and systemic inflammatory response syndrome ( SIRS ) , the typical response is an elevation of the total complete blood count ( CBC ) and a reduction of the lymphocyte count . This leukocytosis typically returns to normal within 48 hours . The persistence of a leukocytosis following trauma is associated with adverse outcomes . Although lymphocyte anergy and dysfunction following trauma is associated with increased risk for infection and sepsis , there is a paucity of data regarding the impact of a persistence of a low lymphocyte count in trauma patients . Methods This is a retrospective review of prospect ively collected data from trauma patients collected over the 5 years of September 2003 to September 2008 . Patients were included if the injury severity score ( ISS ) was > /=15 , and they survived at least 3 days . Demographic data , mechanism and injury severity score , mortality , and length of stay were collected from the medical record . Laboratory values for the first 4 hospital days were collected . Leukocyte , neutrophil and lymphocyte counts were extracted from the daily complete blood count ( CBC ) . Patients were then grouped based on response ( elevation/depression ) of each component of the CBC , and their return , or failure thereof , to normal . Proportional hazards regression with time-varying covariates as well as Kaplan-Meier curves were used to predict risk of death , time to death and time to healthy discharge based on fluctuations of the individual components of the CBC . Results There were 2448 patients admitted over the 5 years included in the analysis . When adjusting for age , gender and ISS the relative risk of death was elevated with a persistent leukocytosis ( 2.501 ( 95 % CI = 1.477 - 4.235 ) ) or failure to normalize lymphopenia ( 1.639 ( 95 % CI = 10.17 - 2.643 ) ) within the first 4 days following admission . Similar results were seen when Kaplan-Meier curves were created . Persistent lymphopenia was associated with shortest time to death . Paradoxically in survivors persistent lymphopenia was associated with the shortest time to discharge . Conclusions Persistently abnormal CBC responses are associated with a higher mortality following trauma . This is the first report noting that a failure to normalize lymphopenia in severely injured patients is associated with significantly higher mortality",
"BACKGROUND The National Veterans Affairs Surgical Risk Study was design ed to collect reliable , valid data on patient risk and outcomes for major surgery in the Veterans Health Administration and to report comparative risk-adjusted postoperative mortality and morbidity rates for surgical services in the Veterans Health Administration . STUDY DESIGN This was a cohort study conducted at 44 Veterans Affairs Medical Centers closely affiliated with university medical centers . Included were 87,078 major noncardiac operations performed under general , spinal , or epidural anesthesia between October 1 , 1991 , and December 31 , 1993 . The main outcomes measures in this report are 21 postoperative adverse events ( morbidities ) occurring within 30 days after the index procedure . Multivariable logistic regression risk-adjustment models for all operations and for eight surgical subspecialties were developed . RESULTS Patient risk factors predictive of postoperative morbidity included serum albumin level , American Society of Anesthesia class , the complexity of the operation , and 17 other preoperative risk variables . Wide variation in the unadjusted rates of one or more postoperative morbidities for all operations was observed across the 44 hospitals ( 7.4 - 28.4 % ) . Risk-adjusted observed-to-expected ratios ranged from 0.49 to 1.46 . The Spearman rank order correlation between the ranking of the hospitals based on unadjusted morbidity rates and risk-adjusted observed-to-expected ratios for all operations was 0.87 . There was little or no correlation between the rank order of the hospitals by risk-adjusted morbidity and risk-adjusted mortality . CONCLUSIONS The Department of Veterans Affairs has successfully implemented a system for the prospect i ve collection and comparative reporting of postoperative mortality and morbidity rates after major noncardiac operations . Risk adjustment had only a modest effect on the rank order of the hospitals",
"BACKGROUND The use of surgical outcome in the comparative assessment of the quality of surgical care is predicted on the development of proper models that adjust for the severity of the preoperative risk factors of the patient . The National Veterans Administration Surgical Risk Study was design ed to collect reliable , valid data about patient risk and outcome for major surgery in the Veterans Health Administration ( VHA ) and to report comparative risk-adjusted surgical morbidity and mortality rates for surgical services in VHA . This study describes the rationale and methods used in the Risk Study and reports on the frequency distribution of the data elements that will be used in the development of risk-adjusted reporting of surgical outcome . STUDY DESIGN This study was a prospect i ve observational study in which dedicated nurses collected preoperative , intraoperative , and outcome data on patients undergoing noncardiac operations using general , spinal , and epidural anesthesia in 44 Veterans Administration Medical Centers . Outcome measures included all cause mortality within the 30 days after the index procedure and 21 major morbidities . RESULTS Eighty-three thous and nine hundred fifty-eight cases meeting inclusion criteria were entered in the study between October 1 , 1991 and December 31 , 1993 . Ninety-seven percent of patients were men , with a mean age of 60.1 + /- 13.6 ( st and ard deviation ) years . The most common preoperative risk factors were smoking ( 40.7 percent ) and hypertension ( 36.1 percent ) . Of the patients , 84.6 percent had one or more risk factors . The most common procedures were transurethral resection of the prostate gl and ( 6.7 percent ) , total knee replacement ( 3.1 percent ) , thromboendarterectomy ( 2.4 percent ) , partial colectomy ( 2.2 percent ) , and total hip replacement ( 2 percent ) . The unadjusted mortality rate was 3.1 percent at 30 days . The most common postoperative morbidities were pneumonia ( 3.6 percent ) , urinary tract infection ( 3.5 percent ) , and failure to wean from the ventilator at 48 hours postoperatively ( 3.2 percent ) . Seventeen percent of the patients have one or more major complications . CONCLUSIONS The Veterans Health Administration has successfully implemented an outcome reporting system for major surgery that prospect ively collects patient risk and outcome information reliably and validly . Risk adjustment models and comparative hospital-specific rates of risk-adjusted outcomes are currently being developed",
"OBJECTIVE Risk scores have become an important tool in patient assessment , as age , severity of heart disease , and comorbidity in patients undergoing heart surgery have considerably increased . Various risk scores have been developed to predict mortality after heart surgery . However , there are significant differences between scores with regard to score design and the initial patient population on which score development was based . It was the purpose of our study to compare six commonly used risk scores with regard to their validity in our patient population . METHODS Between September 1 , 1998 and February 28 , 1999 , all adult patients undergoing heart surgery with cardiopulmonary bypass in our institution were preoperatively scored using the initial Parsonnet , Clevel and Clinic , French , Euro , Pons , and Ontario Province Risk ( OPR ) scores . Postoperatively , we registered 30-day mortality , use of mechanical assist devices , renal failure requiring hemodialysis or hemofiltration , stroke , myocardial infa rct ion , and duration of ventilation and intensive care stay . Score validity was assessed by calculating the area under the ROC curve . Odds ratios were calculated to investigate the predictive relevance of risk factors . RESULTS Follow-up was able to be completed in 504 prospect ively scored patients . Receiver operating characteristics ( ROC ) curve analysis for mortality showed the best predictive value for the Euro score . Predictive values for morbidity were considerably lower than predictive values for mortality in all of the investigated score systems . For most risk factors , odds ratios for mortality were substantially different from ratios for morbidity . CONCLUSIONS Among the investigated scores , the Euro score yielded the highest predictive value in our patient population . For most risk factors , predictive values for morbidity were substantially different from predictive values for mortality . Therefore , development of specific morbidity risk scores may improve prediction of outcome and hospital cost . Due to the heterogeneity of morbidity events , future score systems may have to generate separate predictions for mortality and major morbidity events",
"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",
"OBJECTIVE To examine the association between the outcomes of a pre-operative comprehensive geriatric assessment ( CGA ) and the risk of severe post-operative complications in elderly patients electively operated for colorectal cancer . METHODS One hundred seventy-eight consecutive patients ≥ 70 years electively operated for all stages of colorectal cancer were prospect ively examined . A pre-operative CGA was performed , and patients were categorized as fit , intermediate , or frail . The main outcome measure was severe complications within 30 days of surgery . RESULTS Twenty-one patients ( 12 % ) were categorized as fit , 81 ( 46 % ) as intermediate , and 76 ( 43 % ) as frail . Eighty-three patients experienced severe complications , including three deaths ; 7/21 ( 33 % ) of fit patients , 29/81 ( 36 % ) of intermediate patients and 47/76 ( 62 % ) of frail patients ( p=0.002 ) . Increasing age and ASA classification were not associated with complications in this series . CONCLUSION CGA can identify frail patients who have a significantly increased risk of severe complications after elective surgery for colorectal cancer",
"BACKGROUND The role of nutritional status in the disablement process is still unclear . The objective of this study was to assess whether low concentrations of nutrients predict the development and course of disability . METHODS Longitudinal study including community-dwelling women 65 years or older enrolled in the Women 's Health and Aging Study I. In total , 643 women were assessed prospect ively at 6-month intervals from 1992 to 1995 . RESULTS Incidence rates of disability in activities of daily living ( ADLs ) during 3 years of follow-up . Incidence rates in the lowest quartile of each selected nutrient were compared with those in the upper quartiles . The hazard ratios were estimated from Cox models adjusted for potential confounders . Women in the lowest quartile of serum concentrations of vitamin B(6 ) ( hazard ratio [ HR ] , 1.31 ; 95 % confidence interval [ CI ] , 1.03 - 1.67 ) , vitamin B(12 ) ( HR , 1.40 ; 95 % CI , 1.12 - 1.74 ) , and selenium ( HR , 1.38 ; 95 % CI , 1.12 - 1.71 ) had significantly higher risk of disability in ADLs during 3 years of follow-up compared with women in the upper 3 quartiles . CONCLUSIONS Low serum concentrations of vitamins B(6 ) and B(12 ) and selenium predict subsequent disability in ADLs in older women living in the community . Nutritional status is one of the key factors to be considered in the development of strategies aim ed at preventing or delaying the disablement process",
"BACKGROUND The National Veterans Affairs Surgical Risk Study was design ed to collect reliable , valid data on patient risk and outcomes for major surgery in the Veterans Health Administration and to report comparative risk-adjusted postoperative mortality rates for surgical services in Veterans Health Administration . STUDY DESIGN This cohort study was conducted in 44 Veterans Affairs Medical Centers . Included were 87,078 major noncardiac operations performed under general , spinal , or epidural anesthesia between October 1 , 1991 , and December 31 , 1993 . The main outcomes measure was all-cause mortality within 30 days after the index procedure . Multivariable logistic regression risk-adjustment models for all operations and for eight surgical subspecialties were developed . Risk-adjusted surgical mortality rates were expressed as observed-to-expected ratios and were compared with unadjusted 30-day postoperative mortality rates . RESULTS Patient risk factors predictive of postoperative mortality included serum albumin level , American Society of Anesthesia class , emergency operation , and 31 additional preoperative variables . Considerable variability in unadjusted mortality rates for all operations was observed across the 44 hospitals ( 1.2 - 5.4 % ) . After risk adjustment , observed-to-expected ratios ranged from 0.49 to 1.53 . Rank order correlation of the hospitals by unadjusted and risk-adjusted mortality rates for all operations was 0.64 . Ninety-three percent of the hospitals changed rank after risk adjustment , 50 % by more than 5 and 25 % by more than 10 . CONCLUSIONS The Department of Veterans Affairs has successfully implemented a system for the prospect i ve collection and comparative reporting of risk-adjusted postoperative mortality rates after major noncardiac operations . Risk adjustment had an appreciable impact on the rank ordering of the hospitals and provided a means for monitoring and potentially improving the quality of surgical care",
"IMPORTANCE The increasing number of elderly and comorbid patients undergoing surgical procedures raises interest in better identifying patients at increased risk of morbidity and mortality , independent of age . Frailty has been identified as a predictor of surgical complications . OBJECTIVE To establish the implication s of frailty as a predictor of morbidity and mortality in inpatient otolaryngologic operations . DESIGN Retrospective review of medical records . SETTING National Surgical Quality Improvement Program ( NSQIP ) participating hospitals . PATIENTS NSQIP participant use files were used to identify 6727 in patients who underwent operations performed by surgeons specializing in otolaryngology between 2005 and 2010 . The study sample was 50.3 % male and 10.2 % African American , with a mean ( range ) age of 54.7 ( 16 - 90 ) years . MAIN OUTCOMES AND MEASURES A previously described modified frailty index ( mFI ) was calculated on the basis of NSQIP variables . The effect of increasing frailty on morbidity and mortality was evaluated using univariate analysis . Multivariate logistic regression was used to compare mFI with age , ASA , and wound classification . RESULTS The mean ( range ) mFI was 0.07 ( 0 - 0.73 ) . As the mFI increased from 0 ( no frailty-associated variables ) to 0.45 ( 5 of 11 ) or higher , mortality risk increased from 0.2 % to 11.9 % . The risk of Clavien-Dindo grade IV complications increased from 1.2 % to 26.2 % . The risk of all complications increased from 9.5 % to 40.5 % . All results were significant at P mortality or serious complication , mFI became the dominant significant predictor . CONCLUSIONS AND RELEVANCE The mFI is significantly associated with morbidity and mortality in this retrospective survey . Additional study with prospect i ve analysis and external validation is needed . The mFI may provide an improved underst and ing of preoperative risk , which would facilitate perioperative optimization , risk stratification , and counseling related to outcomes",
"The ability to predict outcomes following a kidney transplant is limited by the complex physiologic decline of kidney failure , a latent factor that is difficult to capture using conventional comorbidity assessment . The frailty phenotype is a recently described inflammatory state of increased vulnerability to stressors result ing from decreased physiologic reserve and dysregulation of multiple physiologic systems . We hypothesized that frailty would be associated with delayed graft function , based on putative associations between inflammatory cytokines and graft dysfunction . We prospect ively measured frailty in 183 kidney transplant recipients between December 2008 and April 2010 . Independent associations between frailty and delayed graft function were analyzed using modified Poisson regression . Preoperative frailty was independently associated with a 1.94-fold increased risk for delayed graft function ( 95 % CI , 1.13 - 3.36 ; P = .02 ) . The assessment of frailty may provide further insights into the pathophysiology of allograft dysfunction and may improve our ability to preoperatively risk-stratify kidney transplant recipients",
"Background Individuals ≥80 years of age represent an increasing proportion of colon cancer diagnoses . Selecting these patients for elective surgery is challenging because of diminished overall health , functional decline , and limited data to guide decisions . The objective was to identify overall health measures that are predictive of poor survival after elective surgery in these oldest-old colon cancer patients . Methods Medicare beneficiaries ≥80 years who underwent elective colectomy for stage I – III colon cancer from 1992–2005 were identified from the Surveillance , Epidemiology and End Results (SEER)-Medicare data base . Kaplan – Meier survival analysis determined 90-day and 1-year overall survival . Multivariable logistic regression assessed factors associated with short-term postoperative survival . Results Overall survival for the 12,979 oldest-old patients undergoing elective colectomy for colon cancer was 93.4 and 85.7 % , at 90 days and 1 year . Older age , male gender , frailty , increased hospitalizations in prior year , and dementia were most strongly associated with decreased survival . In addition , AJCC stage III ( vs stage I ) disease and widowed ( vs married ) were highly associated with decreased survival at 1 year . Although only 4.4 % of patients were considered frail , this had the strongest association with mortality , with an odds ratio of 8.4 ( 95 % confidence interval , 6.4–11.1 ) . Conclusions Although most oldest-old colon cancer patients do well after elective colectomy , a significant proportion ( 6.6 % ) die by postoperative day 90 and frailty is the strongest predictor . The ability to identify frailty through billing cl aims is intriguing and suggests the potential to prospect ively identify , through the electronic medical record , patients at highest risk of decreased survival ",
"Background Frailty is a phenotype characterized by complex and challenging medical problems and higher susceptibility to adverse health outcomes . It can be derived at by a multidimensional process known as comprehensive geriatric assessment ( CGA ) , which assesses the functional reserves of the elderly . In this study we report for the first time on a prospect i ve evaluation of the association between CGA and postoperative complications after elective laparoscopic cholecystectomy for biliary disease . Methods Fifty-seven patients older than 65 years who were to undergo elective laparoscopic cholecystectomy for uncomplicated biliary disease were prospect ively examined . Preoperative CGA was performed and the patients were categorized as fit or frail . The main outcome of the study was the rate of any postoperative complication within 30 days of surgery . Results There were 29 women ( 50.9 % ) and the median ( interquartile range ) age of the cohort was 73 ( 8.8 ) years . Thirty-two patients ( 56.1 % ) were categorized as frail and 25 ( 43.9 % ) as fit . The overall incidence of postoperative complications was 23.7 % , most of which were grade I and II ( 18.8 % ) . Frail patients , according to the CGA assessment , experienced a significantly higher incidence of postoperative complications compared to their fit counterparts ( 84.6 vs. 15.4 % , p = 0.023 ) . Frail patients experienced a significantly higher frequency of prolonged ( more than 2 days ) postoperative hospital stay compared with their fit counterparts ( p = 0.023 ) . Conclusions Preoperative CGA may predict postoperative complications and prolonged postoperative hospital stay of elderly patients who undergo elective laparoscopic cholecystectomy . Larger-scale studies independently assessing this association are warranted",
"Objective : To prospect ively evaluate the additional value of geriatric assessment ( GA ) for predicting surgical outcomes in a cohort of older patients undergoing a pancreaticoduodenectomy ( PD ) for pancreatic tumors . Background : Older patients are less often referred for possible PD . St and ard preoperative assessment s may underestimate the likelihood of significant adverse outcomes . The prospect i ve utility of vali date d GA has not been studied in this group . Methods : PD-eligible patients were enrolled in a prospect i ve outcome study . St and ard preoperative assessment s were recorded . Elements of vali date d GA were also measured , including components of Fried 's model of frailty , the Vulnerable Elders Survey ( VES-13 ) , and the Short Physical Performance Battery ( SPPB ) . All postoperative adverse events were recorded , systematic ally review ed , and grade d using the Clavien-Dindo system by a surgeon blinded to the GA results . Multivariate regression analyses were conducted . Results : Seventy-six older patients underwent a PD . Significant unrecognized vulnerability was identified at the baseline : Fried 's “ exhaustion ” ( 37.3 % ) , SPPB 3 ( 15.4 % ) . Within 30 days of PD , 46 % experienced a severe complication ( Clavien-Dindo grade ≥III ) . In regression analyses controlling for age , the body mass index , the American Society of Anesthesiologists score , and comorbidity burden , Fried 's “ exhaustion ” predicted major complications [ odds ratio ( OR ) = 4.06 ; P = 0.01 ] , longer hospital stays ( & bgr ; = 0.27 ; P = 0.02 ) , and surgical intensive care unit admissions ( OR = 4.30 ; P = 0.01 ) . Both SPPB ( OR = 0.61 ; P = 0.04 ) and older age predicted discharge to a rehabilitation facility ( OR = 1.1 ; P lower likelihood of hospital readmission ( OR = 0.94 ; P = 0.02 ) . Conclusions : Controlling for st and ard preoperative assessment s , worse scores on GA prospect ively and independently predicted important adverse outcomes . Geriatric assessment may help identify older patients at high risk for complications from PD",
"BACKGROUND The clinical syndrome of frailty identified through the assessment of weight loss , gait speed , grip strength , physical activity , and physical exhaustion has been used to identify patients with reduced reserves . We hypothesized that frailty is useful in predicting adverse outcomes in optimized elective elderly colorectal surgery patients . METHODS A prospect i ve study was conducted at 2 centers ( Singapore and Japan ) . All patients over 75 years of age undergoing colorectal resection were assessed for the presence of the syndrome of frailty . All these patients had already had their comorbidities optimized for surgery . The outcome measure was postoperative major complications ( defined as Clavien-Dindo type II and above complications ) . RESULTS Eighty-three patients were studied from February 2008 to April 2010 . The mean age was 81.5 years ( range 75 - 93 years ) . The mean comorbidity index was 3.37 ( range 0 - 11 ) . Twenty-six ( 31.3 % ) patients were an American Society of Anesthesiologists ( ASA ) score of 3 and above . Chi-square analysis revealed that the odds ratio of postoperative major complications was 4.083 ( 95 % confidence interval , 1.433 - 11.638 ) when the patient satisfied the criteria for frailty . Albumin ASA > 3 , comorbidity index > 5 , and Physiologic and Operative Severity Score for the enUmeration of Mortality and Morbidity ( POSSUM ) scores were not predictive of postoperative major complications . CONCLUSIONS Preliminary findings show that frailty is a potent adjunctive tool of predicting postoperative morbidity . Frailty can be used to identify elderly patients needing further optimization before major surgery"
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Different early intervention programs , developed predominantly in the US , for preschool aged children with autism spectrum disorders ( ASD ) have been published . Several systematic review articles including a German Health Technology Assessment on behavioural and skill-based early interventions in children with ASD reported insufficient evidence and a substantial problem of generalisability to the German context . In Germany , approx . 2–5 h early intervention is supported by social services . Here , we report the results of a 1 year pre – post pilot study on a developmentally based social pragmatic approach , the Frankfurt Early Intervention program FFIP . In FFIP , individual 2:1 , behaviourally and developmentally based therapy with the child is combined with parent training and training of kindergarten teachers . Treatment frequency is 2 h/week . Outcome measures were the Vinel and Adaptive Behaviour Scales II ( VABS ) , mental age and the ADOS severity score . Improvements after 1 year were observed for the VABS socialisation scale and the mental age quotient/IQ ( medium effect sizes ) . Results are comparable with several other studies with a similar or slightly higher therapeutic intensity implementing comparable or different early intervention methods or programs . Compared to most high-intensity programs ( 30–40 h/week ) , lower cognitive gains were observed . Results have to be replicated and assessed by a r and omized-controlled study before any final conclusions can be drawn
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"This study reports results of a r and omized controlled trial aim ed at joint attention ( JA ) and symbolic play ( SP ) in preschool children with autism , with prediction to language outcome 12 months later . Participants were 58 children ( 46 boys ) with autism between 3 and 4 years of age . Children were r and omized to a JA intervention , an SP intervention , or control group . Interventions were conducted 30 min daily for 5 - 6 weeks . Assessment s of JA skills , SP skills , mother-child interactions , and language development were collected at 4 time points : pre- and postintervention and 6 and 12 months postintervention by independent testers . Results indicate that expressive language gains were greater for both treatment groups compared with the control group , and results could not be explained by differences in other interventions in which children participated . For children beginning treatment with the lowest language levels , the JA intervention improved language outcome significantly more than did the SP or control interventions . These findings suggest clinical ly significant benefits of actively treating JA and SP skills in young children with autism",
"BACKGROUND Few studies have looked at the very long-term outcome of individuals with autism who were diagnosed in childhood . METHODS A longitudinal , prospect i ve , community-based follow-up study of adults who had received the diagnosis of autism ( classic and atypical ) in childhood ( n = 105 ) was conducted . A structured interview ( the Diagnostic Interview for Social and COmmunication disorders -- the DISCO ) was used in order to evaluate symptoms and symptom patterns 13 - 22 years after original diagnosis . Childhood measures , including IQ-level at time of childhood diagnosis and communicative speech registered before age 5 years , were studied in relation to the presence of autism symptoms at follow-up . RESULTS The classical and atypical autism groups were fairly homogeneously impaired in terms of symptoms in the social interaction category whereas other common childhood autism symptoms , including maladaptive and stereotyped behaviours , were more variable in the study group at follow-up . Odd responses to sensory stimuli were still extremely common . Speech before 5 years of age , IQ , gender , diagnosed medical disorder and onset of epilepsy before 5 years were variables that correlated to outcome on the DISCO algorithm for autistic spectrum disorders ( Wing & Gould , 1979 ) concerning style and quality of social interaction , communication style and pattern of self-chosen activities . CONCLUSIONS Social interaction problems were still present in the vast majority of adults with autism/atypical autism , but behavioural impairments were much more variable in adulthood . Almost all cases were reported to show persistent perceptual problems . Certain childhood measures were found to prospect ively predict adult social interaction style , communication type , and pattern of self-chosen activities , which still met diagnostic criteria for autism/atypical autism in adulthood",
"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",
"Early intervention has been reported to improve outcome in children with autism spectrum disorders ( ASDs ) . Several studies in the field have been r and omized controlled trials ( RCTs ) . The aim of this study was to assess ASD outcome in a large naturalistic study . Two hundred and eight children , aged 20 - 54 months , with a clinical diagnosis of ASD were given intervention and monitored prospect ively in a naturalistic fashion over a period of 2 years . The toddlers were considered representative of all but the most severely multiple disabled preschool children with ASD in Stockholm county . They fell into three cognitive subgroups : one with learning disability , one with developmental delay , and one with normal intellectual functioning . Data on intervention type and intensity were gathered prospect ively in a systematic fashion . Intervention was classified into intensive applied behaviour analysis ( ABA ) and non-intensive , targeted interventions , also based on ABA principles . Children were comprehensively assessed by a research team before the onset of intervention , and then , again , 2 years later . Change in Vinel and adaptive behaviour scales composite scores from intake ( T1 ) to leaving the study ( T2 ) was set as the primary outcome variable . The research team remained blind to the type and intensity of interventions provided . One hundred and ninety-eight ( 95 % ) of the original sample s stayed in the study throughout the whole 2-year period and 192 children had a complete Vinel and composite score results both at T1 and T2 . Vinel and composite scores increased over the 2-year period . This increase was accounted for by the subgroup with normal cognitive functioning . There was no significant difference between the intensive and non-intensive groups . Individual variation was considerable , but no child in the study was \" problem-free \" at follow-up . Our data do not support that children with ASD generally benefit more from the most intensive ABA intervention programs than from less intensive interventions or targeted interventions based on ABA",
"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",
"This study evaluated the effectiveness of low intensity behavioral treatment ( on average 6.5h per week ) supplementing preschool services in 3 - 6-year-old children with autism spectrum disorder and severe to mild intellectual disability . Treatment was implemented in preschools ( i.e. , daycare centers ) and a discrete trial teaching approach was used . Twelve children in the treatment group were compared to 22 children receiving regular intervention . At pre-treatment , both groups did not differ on chronological age , developmental age , diagnosis and level of adaptive skills . Eight months into treatment , children receiving behavioral treatment displayed significantly higher developmental ages and made more gains in adaptive skills than children from the control group . No significant differences between groups were found on autistic symptom severity and emotional and behavioral problems",
"BACKGROUND This prospect i ve study compared outcome for pre-school children with autism spectrum disorders ( ASD ) receiving autism-specific nursery provision or home-based Early Intensive Behavioural Interventions ( EIBI ) in a community setting . METHODS Forty-four 23- to 53-month-old children with ASD participated ( 28 in EIBI home-based programmes ; 16 in autism-specific nurseries ) . Cognitive , language , play , adaptive behaviour skills and severity of autism were assessed at intake and 2 years later . RESULTS Both groups showed improvements in age equivalent scores but st and ard scores changed little over time . At follow-up , there were no significant group differences in cognitive ability , language , play or severity of autism . The only difference approaching significance ( p = .06 ) , in favour of the EIBI group , was for Vinel and Daily Living Skills st and ard scores . However , there were large individual differences in progress , with intake IQ and language level best predicting overall progress . CONCLUSIONS Home-based EIBI , as implemented in the community , and autism-specific nursery provision produced comparable outcomes after two years of intervention",
"This study was design ed to evaluate 1 year of intensive treatment for 4- to 7-year-old children with autism . An independent clinician assigned children to either behavioral treatment ( n = 13 ) or eclectic treatment ( n = 12 ) . Assignment was based on availability of personnel to supervise treatment and was not influenced by child characteristics or family preference . The two treatment groups received similar amounts of treatment ( M = 28.52 hours per week at the child ’s school ) . Children in the behavioral treatment group made significantly larger gains on st and ardized tests than did children in the eclectic treatment group . Results suggest that some 4- to 7-year-olds may make large gains with intensive behavioral treatment , that such treatment can be successfully implemented in school setting s , and that specific aspects of behavioral treatment ( not just its intensity ) may account for favorable outcomes",
"ABSTRACT . Although previous studies have shown favorable results with early intensive behavioral treatment ( EIBT ) for children with autism , it remains important to replicate these findings , particularly in community setting s. The authors conducted a 3-year prospect i ve outcome study that compared 2 groups : ( 1 ) 21 children who received 35 to 40 hours per week of EIBT from a community agency that replicated Lovaas ' model of EIBT and ( 2 ) 21 age- and IQ-matched children in special education classes at local public schools . A quasi-experimental design was used , with assignment to groups based on parental preference . Assessment s were conducted by independent examiners for IQ ( Bayley Scales of Infant Development or Wechsler Preschool and Primary Scales of Intelligence ) , language ( Reynell Developmental Language Scales ) , nonverbal skill ( Merrill-Palmer Scale of Mental Tests ) , and adaptive behavior ( Vinel and Adaptive Behavior Scales ) . Analyses of covariance , with baseline scores as covariates and Year 1 - 3 assessment s as repeated measures , revealed that , with treatment , the EIBT group obtained significantly higher IQ ( F = 5.21 , p = .03 ) and adaptive behavior scores ( F = 7.84 , p = .01 ) than did the comparison group . No difference between groups was found in either language comprehension ( F = 3.82 , p = .06 ) or nonverbal skill . Six of the 21 EIBT children were fully included into regular education without assistance at Year 3 , and 11 others were included with support ; in contrast , only 1 comparison child was placed primarily in regular education . Although the study was limited by the nonr and om assignment to groups , it does provide evidence that EIBT can be successfully implemented in a community setting",
"This r and omized controlled trial compared results obtained after 12 months of nonintensive parent training plus care-as-usual and care-as-usual alone . The training focused on stimulating joint attention and language skills and was based on the intervention described by Drew et al. ( Eur Child Adolesc Psychiatr 11:266–272 , 2002 ) . Seventy-five toddlers with autism spectrum disorder ( 65 autism , 10 PDD-NOS , mean age = 34.4 months , SD = 6.2 ) were enrolled . Analyses were conducted on a final sample of 67 children ( lost to follow-up = 8) . No significant intervention effects were found for any of the primary ( language ) , secondary ( global clinical improvement ) , or mediating ( child engagement , early precursors of social communication , or parental skills ) outcome variables , suggesting that the ‘ Focus parent training ’ was not of additional value to the more general care-as-usual",
"This article evaluates the effectiveness of a developmentally based early intervention programme . Two groups of children were compared , a treatment group and a no-treatment control group . St and ardized assessment s were administered before and after the intervention period by an independent clinician . Pre-treatment comparisons revealed that the control group had a significantly higher pre-treatment IQ ; but the two groups were comparable for age , mental age , socioeconomic status and number of hours of non-experimental therapy . Results demonstrated that children in the treatment group improved significantly more than those in the control group on measures of joint attention , social interaction , imitation , daily living skills , motor skills and an adaptive behaviour composite . A measure of requesting behaviour fell short of statistical significance . The total stress index reduced for treatment group parents and increased for the control group parents ( but not significantly ) . The results of the study are considered to support the efficacy of this treatment approach",
"Data from Norway were analyzed to evaluate early behavioral intervention for children with intellectual disabilities . The intervention group ( n = 11 ) received approximately 10 hours per week of behavioral intervention ; the eclectic comparison group ( n = 14 ) received treatment as usual . After 1 year , changes in intelligence and adaptive behavior scores were statistically significant in favor of the behavioral intervention group ( effect sizes of 1.13 for Intelligence quotient ( IQ ) change and .95 for change in adaptive behavior composite ) . Approximately 64 % of the children in the behavioral intervention group met objective criteria for reliable change in IQ , whereas 14 % in the eclectic comparison group did so . These results suggest that children with intellectual disability may profit from behavioral intervention typically provided for children with autism"
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BACKGROUND It is uncertain whether multiple health behaviour change ( MHBC ) interventions are effective for the primary prevention of cardiovascular disease ( CVD ) in primary care . A systematic review and a meta- analysis were performed to evaluate the effectiveness of MHBC interventions on CVD risk and CVD risk factors ; the study also evaluated associations of theoretical frameworks and intervention components with intervention effectiveness . METHODS The search included r and omised controlled trials of MHBC interventions aim ed at reducing CVD risk in primary prevention population up to 2017 . Theoretical frameworks and intervention components were evaluated using st and ardised methods . Meta- analysis with stratification and meta-regression were used to evaluate intervention effects . RESULTS We identified 31 trials ( 36 484 participants ) with a minimum duration of 12 months follow-up . Pooled net change in systolic blood pressure ( 16 trials ) was -1.86 ( 95 % CI -3.17 to -0.55 ; p=0.01 ) mm Hg ; diastolic blood pressure ( 15 trials ) , -1.53 ( -2.43 to -0.62 ; p=0.001 ) mm Hg ; body mass index ( 14 trials ) , -0.13 ( -0.26 to -0.01 ; p=0.04 ) kg/m2 ; serum total cholesterol ( 14 trials ) , -0.13 ( -0.19 to -0.07 ; p intervention outcomes . No association was observed between intervention intensity ( number of sessions and intervention duration ) and intervention outcomes . There was significant heterogeneity for some risk factor analyses , leading to uncertain validity of some pooled net changes . CONCLUSIONS MHBC interventions delivered to CVD-free participants in primary care did not appear to have quantitatively important effects on CVD risk factors . Better reporting of interventions ' rationale , content and delivery is essential to underst and ing their effectiveness
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"The prevalence of type 2 diabetes is continuously increasing . This chronic metabolic disorder is difficult to treat and imposes a considerable economic burden on the healthcare system . In view of the fact that type 2 diabetes is primarily caused by behavioral factors , effective preventive strategies are urgently needed . We examined the effects of a holistic lifestyle intervention on clinical and laboratory parameters as well as on the long-term diabetes risk in patients at risk to develop diabetes . We conducted a r and omized controlled trial in a primary care setting in Hannover , Germany , with 83 patients diagnosed as (pre)diabetic or at risk for diabetes . CHIP Germany is a 40-hour coaching lifestyle intervention program for the primary and secondary prevention of type 2 diabetes and cardiovascular diseases . The intervention included a comprehensive nutrition and health educational program based on the American CHIP approach . The primary outcome parameter was the body mass index ( BMI ) . Secondary outcome parameters included body weight , blood pressure , fasting glucose , HbA1c , blood lipids , and the FINDRISK score , which assesses long-term diabetes risk . At the final measurement after 12 months , in the intervention group the BMI was reduced by 1.4 versus 0.2 kg/m2 in controls ( p = .119 ) . The mean sustained weight loss after 12 months was −4.1 kg in the intervention group versus −0.8 kg in controls . Furthermore , we found a trend toward a stronger reduction in blood pressure , fasting glucose , and HbA1c as well as an improved FINDRISK score in the intervention group , compared to controls . Although failing to reach statistical significance at the final assessment , this comprehensive lifestyle intervention showed a noticeable reduction in several cardiometabolic risk factors which may facilitate the prevention of diabetes",
"Background Treatment goals for cardiovascular risk management are generally not achieved . Specialized practice nurses are increasingly facilitating the work of general practitioners and self-monitoring devices have been developed as counseling aid . The aim of this study was to compare st and ard treatment supported by self-monitoring with st and ard treatment without self-monitoring , both conducted by practice nurses , on cardiovascular risk and separate risk factors . Methods Men aged 50–75 years and women aged 55–75 years without a history of cardiovascular disease or diabetes , but with a SCORE 10-year risk of cardiovascular mortality ≥5 % and at least one treatable risk factor ( smoking , hypertension , lack of physical activity or overweight ) , were r and omized into two groups . The control group received st and ard treatment according to guidelines , the intervention group additionally received pro-active counseling and self-monitoring ( pedometer , weighing scale and / or blood pressure device ) . After one year treatment effect on 179 participants was analyzed . Results SCORE risk assessment decreased 1.6 % ( 95 % CI 1.0–2.2 ) for the control group and 1.8 % ( 1.2–2.4 ) for the intervention group , difference between groups was .2 % ( −.6–1.1 ) . Most risk factors tended to improve in both groups . The number of visits was higher and visits took more time in the intervention group ( 4.9 ( SD2.2 ) vs. 2.6 ( SD1.5 ) visits p groups cardiovascular risk decreased significantly after one year of treatment by practice nurses . No additional effect of basing the pro-active counseling on self-monitoring was found , despite the extra time investment . Trial registration trialregister.nl",
"Background Intensive lifestyle interventions in well-controlled setting s are effective in lowering the risk of chronic diseases such as type 2 diabetes ( T2DM ) and cardiovascular diseases ( CVD ) , but there are still no effective lifestyle interventions for everyday practice . In the Hoorn Prevention Study we aim ed to assess the effectiveness of a primary care based lifestyle intervention to reduce the estimated risk of developing T2DM and for CVD mortality , and to motivate changes in lifestyle behaviors . Methods The Hoorn Prevention Study is a parallel group r and omized controlled trial , implemented in the region of West-Friesl and , the Netherl and s. 622 adults with ≥10 % estimated risk of T2DM and /or CVD mortality were r and omly assigned and monitored over a period of 12 months . The intervention group ( n=314 ) received a theory-based lifestyle intervention based on an innovative combination of motivational interviewing and problem solving treatment , provided by trained practice nurses in 12 general practice s. The control group ( n=308 ) received existing health brochures . Primary outcomes was the estimated diabetes risk according to the formula of the Atherosclerosis Risk In Communities ( ARIC ) Study , and the estimated risk for CVD mortality according to the Systematic COronary Risk Evaluation ( SCORE ) formula . Secondary outcomes included lifestyle behavior ( diet , physical activity and smoking ) . The research assistants , the principal investigator and the general practitioners were blinded to group assignment . Linear and logistic regression analysis was applied to examine the between-group differences in each outcome measure , adjusted for baseline values . Results 536 ( 86.2 % ) of the 622 participants ( age 43.5 years ) completed the 6-month follow-up , and 502 ( 81.2 % ) completed the 12-month follow-up . The mean baseline T2DM risk was 18.9 % ( SD 8.2 ) and the mean CVD mortality risk was 3.8 % ( SD 3.0 ) . The intervention group participated in a median of 2 sessions . Intention-to-treat analyses showed no significant differences in outcomes between the two groups at 6 or 12-months follow-up . Conclusions The lifestyle intervention was not more effective than health brochures in reducing risk scores for T2DM and CVD or improving lifestyle behavior in an at-risk population .Trial registration Current Controlled Trials : IS RCT",
"OBJECTIVE To evaluate a simple cardiovascular risk management package for assessing and managing cardiovascular risk using hypertension as an entry point in primary care facilities in low-re source setting s. METHODS Two geographically distant regions in two countries ( China and Nigeria ) were selected and 10 pairs of primary care facilities in each region were r and omly selected and matched . Regions were then r and omly assigned to a control group , which received usual care , or to an intervention group , which applied the cardiovascular risk management package . Each facility enrolled 60 consecutive patients with hypertension . Intervention sites educated patients about risk factors at baseline and initiated treatment with hydrochlorothiazide at 4 months in patients at medium risk of a cardiovascular event , according to a st and ardized treatment algorithm . Systolic blood pressure change from baseline to 12 months was the primary outcome measure . FINDINGS The study included 2397 patients with baseline hypertension : 1191 in 20 intervention facilities and 1206 in 20 control facilities . Systolic and diastolic blood pressure decreased more in intervention patients than in controls . However , at 12 months more than half of patients still had uncontrolled hypertension ( systolic blood pressure > 140 mmHg and /or diastolic blood pressure > 90 mmHg ) . Behavioural risk factors had improved among intervention patients in Nigeria but not in China . Only about 2 % of hypertensive patients required referral to the next level of care . CONCLUSION Even in low-re source setting s , hypertensive patients can be effectively assessed and managed in primary care facilities",
"OBJECTIVE To measure the change in cardiovascular risk factors achievable in families over one year by a cardiovascular screening and lifestyle intervention in general practice . DESIGN R and omised controlled trial in 26 general practice s in 13 towns in Britain . SUBJECTS 12,472 men aged 40 - 59 and their partners ( 7460 men and 5012 women ) identified by household . INTERVENTION Nurse led programme using a family centred approach with follow up according to degree of risk . MAIN OUTCOME MEASURES After one year the pairs of practice s were compared for differences in ( a ) total coronary ( Dundee ) risk score and ( b ) cigarette smoking , weight , blood pressure , and r and om blood cholesterol and glucose concentrations . RESULTS In men the overall reduction in coronary risk score was 16 % ( 95 % confidence interval 11 % to 21 % ) in the intervention practice s at one year . This was partitioned between systolic pressure ( 7 % ) , smoking ( 5 % ) , and cholesterol concentration ( 4 % ) . The reduction for women was similar . For both sexes reported cigarette smoking at one year was lower by about 4 % , systolic pressure by 7 mm Hg , diastolic pressure by 3 mm Hg , weight by 1 kg , and cholesterol concentration by 0.1 mmol/l , but there was no shift in glucose concentration . Weight , blood pressure , and cholesterol concentration showed the greatest difference at the top of the distribution . If maintained long term the differences in risk factors achieved would mean only a 12 % reduction in risk of coronary events . CONCLUSIONS As most general practice s are not using such an intensive programme the changes in coronary risk factors achieved by the voluntary health promotion package for primary care are likely to be even smaller . The government 's screening policy can not be justified by these results",
"Background Successfully transferring the findings of expensive and tightly controlled programmes of intensive lifestyle modification to the primary care setting is necessary if such knowledge is to be of clinical utility . The objective of this study was to test whether intensive lifestyle modification , shown previously in tightly-controlled clinical trials to be efficacious for diabetes risk-reduction among high-risk individuals , can reduce cardiovascular risk factor levels in the primary care setting . Methodology / Principal Findings The Swedish Björknäs study was a r and omized controlled trial conducted from 2003 to 2006 with follow-up on cardiovascular risk factors at 3 , 12 , 24 and 36 months . A total of 151 middle-aged men and women at moderate- to high-risk of cardiovascular disease from northern Sweden were r and omly assigned to either an intensive lifestyle intervention ( n = 75 ) or control ( n = 76 ) group . The intervention was based broadly on the protocol of the Diabetes Prevention Program . The three-month intervention period was administered in the primary care setting and consisted of supervised exercise sessions and diet counselling , followed by regular group meetings during three years . The control group was given general advice about diet and exercise and received st and ard clinical care . Outcomes were changes in anthropometrics , aerobic fitness , self-reported physical activity , blood pressure , and metabolic traits . At 36 months post-r and omisation , intensive lifestyle modification reduced waist circumference ( −2.2 cm : p = 0.001 ) , waist-hip ratio ( −0.02 : p ) , systolic blood pressure ( −4.9 mmHg : p = 0.036 ) , and diastolic blood pressure ( −1.6 mmHg : p = 0.005 ) , and improved aerobic fitness ( 5 % ; p = 0.038 ) . Changes in lipid or glucose values did not differ statistically between groups . At 36 months , self-reported time spent exercising and total physical activity had increased more in the intervention group than in the control group ( p intensive lifestyle modification undertaken in the primary health care setting can favourably influence cardiovascular risk-factor profiles in high-risk individuals . Trial Registration Clinical Trials.gov",
"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",
"While most intervention studies on coronary heart disease have focused on the high-risk person only , the present study used the family as the unit of intervention . In the study 1373 high-risk men , ages 30 - 54 years , were identified on the basis of high total cholesterol ( TC ) and /or low relative high-density lipoprotein cholesterol ( HDL-C ) ( HDL-C/TC ) following the 1979/1980 survey in Tromsø . The men and their families were r and omly allocated to a control or intervention condition . The intervention families were given advice on diet , smoking , and exercise . At rescreening in 1986/1987 , significantly lower risk factor levels were found in both the intervention men and their spouses compared with those in the control group . For children , the differences were small and mostly nonsignificant . Men , spouses , and children in the intervention group reported more favorable dietary habits than those in the control group . No differences were found in smoking or leisure time physical activity",
"Abstract Objective : To determine the effectiveness of health checks , performed by nurses in primary care , in reducing risk factors for cardiovascular disease and cancer . Design : R and omised controlled trial . Setting : Five urban general practice s in Bedfordshire . Subjects : 2205 men and women who were r and omly allocated a first health check in 1989 - 90 and a re-examination in 1992 - 3 ( the intervention group ) ; 1916 men and women who were r and omly allocated an initial health check in 1992 - 3 ( the control group ) . All subjects were aged 35 - 64 at recruitment in 1989 . Main outcome measures : Serum total cholesterol concentration , blood pressure , body mass index , and smoking prevalence ( with biochemical validation of cessation ) ; self reported dietary , exercise , and alcohol habits . Results : Mean serum total cholesterol was 3.1 % lower in the intervention group than controls ( difference 0.19 mmol/l ( 95 % confidence interval 0.12 to 0.26 ) ; in women it was 4.5 % lower ( P Self reported saturated fat intake was also significantly lower in the intervention group . Systolic and diastolic blood pressures and body mass index were respectively 1.9 % , 1.9 % , and 1.4 % lower in the intervention group ( P cholesterol concentration > /=8 mmol/l , but no significant differences in the number with diastolic blood pressure > /=100 mm Hg or body mass index > /=30 kg/m2 . There was no significant difference between the two groups in prevalence of smoking or excessive alcohol use . Annual rechecks were no more effective than a single recheck at three years , but health checks led to a significant increase in visits to the nurse according to patients ' degree of cardiovascular risk . Conclusions : The benefits of health checks were sustained over three years . The main effects were to promote dietary change and reduce cholesterol concentrations ; small differences in blood pressure may have been attributable to accommodation to measurement . The benefits of systematic health promotion in primary care are real , but must be weighed against the costs in relation to other priorities . Key messages Key messages There is little effect on smoking or alcohol use , and more targeted approaches to modifying these behaviours may be appropriate Systematic implementation of health checks might lead to a reduction in risk of myocardial infa rct ion among those who attend of about 5 - 15 % ; men , who are at higher risk , show less change than women Health checks consume substantial re sources , and their effect is attenuated by non-attendance The benefits of health promotion through primary care must be weighed against their costs and in relation to other",
"Background There is overwhelming evidence that behavioural factors influence health , but their combined impact on the general population is less well documented . We aim ed to quantify the potential combined impact of four health behaviours on mortality in men and women living in the general community . Methods and Findings We examined the prospect i ve relationship between lifestyle and mortality in a prospect i ve population study of 20,244 men and women aged 45–79 y with no known cardiovascular disease or cancer at baseline survey in 1993–1997 , living in the general community in the United Kingdom , and followed up to 2006 . Participants scored one point for each health behaviour : current non-smoking , not physically inactive , moderate alcohol intake ( 1–14 units a week ) and plasma vitamin C > 50 mmol/l indicating fruit and vegetable intake of at least five servings a day , for a total score ranging from zero to four . After an average 11 y follow-up , the age- , sex- , body mass– , and social class – adjusted relative risks ( 95 % confidence intervals ) for all-cause mortality(1,987 deaths ) for men and women who had three , two , one , and zero compared to four health behaviours were respectively , 1.39 ( 1.21–1.60 ) , 1.95 ( 1.70–-2.25 ) , 2.52 ( 2.13–3.00 ) , and 4.04 ( 2.95–5.54 ) p The mortality risk for those with four compared to zero health behaviours was equivalent to being 14 y younger in chronological age . Conclusions Four health behaviours combined predict a 4-fold difference in total mortality in men and women , with an estimated impact equivalent to 14 y in chronological age",
"Background Intensive diet and physical activity interventions have been found to reduce cardiovascular disease ( CVD ) risk , but are re source intensive . The American Heart Association recently recommended motivational interviewing ( MI ) as an effective approach for low-intensity interventions to promote health-related outcomes such as weight loss . However , there is limited research evaluating the long-term effectiveness of MI-based interventions on health-related outcomes associated with CVD risk . The current research evaluated the effectiveness of a six-month low-intensity MI intervention in a UK primary -care setting in maintaining reductions in CVD risk factors at12 months post-intervention . Methods Primary -care patients were r and omised to an intervention group that received st and ard exercise and nutrition information plus up to five face-to-face MI sessions , delivered by a physical activity specialist and registered dietician over a 6-month period , or to a minimal intervention comparison group that received the st and ard information only . Follow-up measures of behavioural ( vigorous and moderate physical activity , walking , physical activity stage-of-change , fruit and vegetable intake , and dietary fat intake ) and biomedical ( weight , body mass index [ BMI ] , blood pressure , cholesterol ) outcomes were taken immediately post-intervention and at a 12-month follow-up occasion . Results Intent-to-treat analyses revealed significant differences between groups for walking and cholesterol . Obese and hypercholesterolemic patients at baseline exhibited significant improvements in BMI and cholesterol respectively among those allocated to the intervention group compared to the comparison group . Post-intervention improvements in other health-related outcomes including blood pressure , weight , and BMI were not maintained . Conclusions The present study suggests that a low-intensity MI counselling intervention is effective in bringing about long-term changes in some , but not all , health-related outcomes ( walking , cholesterol levels ) associated with CVD risk . The intervention was particularly effective for patients with elevated levels of CVD risk factors at baseline . Based on these findings future interventions should be conducted in a primary care setting and target patients with high risk of CVD . Future research should investigate how the long-term gains in health-related outcomes brought about by the MI-counselling intervention in the current study could be extended to a wider range of health outcomes",
"Background The optimal intensity and duration of the intervention to achieve sustained risk reduction in patients at high and very high cardiovascular ( CV ) risk still need to be established . The aim of this study was to evaluate the impact of general practitioner ’s ( GP ’s ) systematic and planned intervention on total CV risk reduction and a change in individual CV risk factors . Material / Methods This was a cluster-r and omized trial ( IS RCT N31857696 ) including 64 practice s and 3245 patients aged ≥40 . The participating GPs and their examinees were r and omized into an intervention or to a control group ( st and ard care ) . Intervention group practitioners followed up their examinees during 1 , 3 , 6 , 12 , and 18 months . The main outcome measures were change in proportion of patients with low , moderate , high , and very high CV risk , and change in individual CV risk factors from the first to the second registration . Results The proportion of patients with very high CV risk was lower in the intervention group , the same as of patients with high blood pressure , total and LDL cholesterol , and increased intake of alcohol . The mean systolic ( −1.49 mmHg ) and diastolic ( −1.57 mmHg ) blood pressure , triglycerides ( −0.18 mmol/L ) , body mass index ( −0.22 ) , and waist ( −0.4 cm ) and hip circumference ( −1.08 cm ) was reduced significantly in the intervention group . There was no additional impact in the intervention group of other tested CV risk factors . Conclusions Systematic and planned GP ’s intervention in CVD prevention reduces the number of patients with very high total CV risk and influences a change in lifestyle habits",
"OBJECTIVES We evaluated a theory-based lifestyle intervention targeting physical activity and dietary fat intake among African American women at high risk for cardiovascular disease . METHODS The Heart Healthy and Ethnically Relevant Lifestyle trial ( 2005 - 2008 ) r and omly assigned 266 low-income African American women aged 35 years and older who were patients of South Carolina community health care centers into comprehensive or st and ard care interventions . Comprehensive participants received st and ard care ( stage-matched provider counseling and assisted goal setting ) plus 12 months of telephone counseling and tailored newsletters . Primary outcomes were 6- and 12-month self-reported physical activity and dietary fat intake . RESULTS Comprehensive participants were more likely than were st and ard care participants to decrease total physical activity ( odds ratio [ OR ] = 3.13 ; 95 % confidence interval [ CI ] = 1.18 , 8.25 ) and increase leisure-time physical activity ( OR = 3.82 ; 95 % CI = 1.41 , 10.3 ) at 6 months ( no 12-month differences ) . Mean reductions in Dietary Risk Assessment score occurred in both groups but were greater among comprehensive participants than among st and ard care participants ( 6 months , -8.50 vs -5.34 ; 12 months , -7.16 vs -3.37 ; P leisure-time physical activity and dietary fat intake , highlighting a replicable model to help primary care providers implement lifestyle counseling",
"OBJECTIVE Insulin resistance and hyperinsulinaemia are , in some prospect i ve studies , linked to an increased cardiovascular risk , at least in men . We tested the hypothesis that hyperinsulinaemia may be reduced by non-pharmacological methods independently of other cardiovascular risk factors . DESIGN In a non-pharmacological intervention study for 1 year three groups of subjects ( hypertensives as well as normotensives ) were selected after stratification for insulin level at baseline . Half of the hyperinsulinaemic subjects were r and omly assigned to active intervention with physical exercise and dietary regulation ( HI-A group ) , the other half were followed passively during the study period ( HI-P group ) . Normo-insulinaemics and hypo(low)-insulinaemics also underwent active intervention ( NI-A and LI-A groups , respectively ) . SETTING Primary health care in Sweden . RESULTS During the 1-year follow-up subjects in the HI-A group reduced their weight , waist : hip ratio and systolic and diastolic blood pressure , as well as their low : high-density lipoprotein (LDL : HDL)-cholesterol ratio . Glucose levels before and during an oral glucose tolerance test did not change . However , plasma insulin and plasma-C-peptide decreased both in the fasting state and after 1 and 2 h of oral glucose tolerance testing . This decrease was independent of the previously mentioned reduction in weight , waist : hip ratio , blood pressure and LDL : HDL-cholesterol ratio . No reduction in insulin levels was seen in the HI-P , NI-A or LI-A groups , but in the HI-P group there was a slight decrease in fasting plasma-C-peptide levels . In the HI-A group dietary improvements were observed during the study period , with a reduction in energy intake , fat consumption and cholesterol intake . Fibre intake was increased . No major changes were seen in the HI-P group . CONCLUSIONS We conclude that in hypertensive and normotensive subjects with hyperinsulinaemia insulin levels can be reduced by active non-pharmacological treatment for 1 year without altering glucose tolerance . This shows that insulin resistance may be lowered by non-pharmacological treatment , which may be of considerable importance , and not only for hypertensives",
"Background : Preventive guidelines on cardiovascular risk management recommend lifestyle changes . Support for lifestyle changes may be a useful task for practice nurses , but the effect of such interventions in primary prevention is not clear . We examined the effect of involving patients in nurse-led cardiovascular risk management on lifestyle adherence and cardiovascular risk . Methods : We performed a cluster r and omized controlled trial in 25 practice s that included 615 patients . The intervention consisted of nurse-led cardiovascular risk management , including risk assessment , risk communication , a decision aid and adapted motivational interviewing . The control group received a minimal nurse-led intervention . The self-reported outcome measures at one year were smoking , alcohol use , diet and physical activity . Nurses assessed 10-year cardiovascular mortality risk after one year . Results : There were no significant differences between the intervention groups . The effect of the intervention on the consumption of vegetables and physical activity was small , and some differences were only significant for subgroups . The effects of the intervention on the intake of fat , fruit and alcohol and smoking were not significant . We found no effect between the groups for cardiovascular 10-year risk . Interpretation : Nurse-led risk communication , use of a decision aid and adapted motivational interviewing did not lead to relevant differences between the groups in terms of lifestyle changes or cardiovascular risk , despite significant within-group differences",
"OBJECTIVE To evaluate the additional benefit of \" intensive \" health care advice through six group sessions , compared with the advice usually offered to subjects with multiple risk factors for cardiovascular disease . DESIGN Prospect i ve , r and omised controlled clinical study lasting 18 months . SETTING 681 subjects aged 30 - 59 years , with at least two cardiovascular risk factors in addition to moderately high lipid concentrations : total cholesterol > or = 6.5 mmol/l on three occasions , triglycerides 4.0 . Most ( 577 ) of the subjects were men . MAIN OUTCOME MEASURE Percentage reduction in total cholesterol concentration ( target 15 % ) ; quantification of the differences between the two types of health care advice ( intensive v usual ) for the Framingham cardiovascular risk and for individual risk factors . RESULTS In the group receiving intensive health care advice total cholesterol concentration decreased by 0.15 mmol/l more ( 95 % confidence interval 0.04 to 0.26 ) than in the group receiving usual advice . The overall Framingham risk dropped by 0.068 more ( 0.014 to 0.095 ) in the group receiving intensive advice , and most of the risk factors showed a greater change in a favourable direction in this group than in the group receiving usual advice , but the differences were seldom significant . The results from question naires completed at the group sessions showed that the subjects improved their lifestyle and diet . CONCLUSION Limited additional benefit was gained from being in the group receiving the intensive health care advice . It is difficult to make an important impact on cardiovascular risk in primary care by using only the practice staff . Better methods of communicating the messages need to be devised",
"R and omized clinical trials of cardiac rehabilitation following myocardial infa rct ion have typically demonstrated a lower mortality in treated patients , but with a statistically significant reduction in only one trial . To overcome the problem of not being able to detect small but clinical ly important benefits in mortality in r and omized clinical trials of exercise and risk factor rehabilitation after myocardial infa rct ion with small numbers of patients , we carried out a meta- analysis on the combined results of ten r and omized clinical trials that included 4347 patients ( control , 2145 patients ; rehabilitation , 2202 patients ) . The pooled odds ratios of 0.76 ( 95 % confidence intervals , 0.63 to 0.92 ) for all-cause death and of 0.75 ( 95 % confidence intervals , 0.62 to 0.93 ) for cardiovascular death were significantly lower in the rehabilitation group than in the control group , with no significant difference for nonfatal recurrent myocardial infa rct ion . These results suggest that , for appropriately selected patients , comprehensive cardiac rehabilitation has a beneficial effect on mortality but not on nonfatal recurrent myocardial infa rct ion",
"BACKGROUND Diet is an essential part of the nonpharmacological management of hypertension . The aim of this study was to investigate in a primary health care setting the effect of intensified diet counseling on the diet of hypertensive subjects . METHODS A total of 715 free-living subjects , ages 25 - 74 years , with systolic blood pressure 140 - 179 mm Hg and /or diastolic blood pressure 90 - 109 mm Hg and /or drug treatment for hypertension participated in an open r and omized trial with a 2-year follow-up at health centers in eastern Finl and . The intervention group ( n = 360 ) was advised to reduce their total fat , saturated fat , and salt intake and to increase monounsaturated and polyunsaturated fat intake as well as to reduce weight and to use alcohol in moderation if at all . The usual care group ( n = 355 ) continued with their usual primary health care . The subjects filled out a 4-day food record , and 24-h urine sample s were collected at baseline and at 1- and 2-year examinations . RESULTS The 2-year net changes ( change in intervention minus change occurring in usual care group ) in total fat intake [ -2.7 E% ( 95 % CI -4.0 , -1.6 ; P saturated fatty acid intake [ -1.7 E% ( 95 % CI -2.3 , -1.1 ; P body weight [ -1.4 kg ( 95 % CI -2.0 , -0.8 ; P daily sodium intake was significant , -9 mmol ( 95 % CI -17 , -2 ; P = 0.021 ) , but the 24-h urinary sodium excretion showed no difference between the study groups . CONCLUSION The intensified diet counseling in primary health care result ed in dietary changes interpreted as being of benefit in the long-term treatment of hypertension and prevention of atherosclerotic vascular diseases",
"Abstract Objective : To measure the effect of behaviourally oriented counselling in general practice on healthy behaviour and biological risk factors in patients at increased risk of coronary heart disease . Design : Cluster r and omised controlled trial . Participants : 883 men and women selected for the presence of one or more modifiable risk factors : regular cigarette smoking , high serum cholesterol concentration ( 6.5 - 9.0 mmol/l ) , and high body mass index ( 25 - 35 ) combined with low physical activity . Intervention : Brief behavioural counselling , on the basis of the stage of change model , carried out by practice nurses to reduce smoking and dietary fat intake and to increase regular physical activity . Main outcome measures : Question naire measures of diet , exercise , and smoking habits , and blood pressure , serum total cholesterol concentration , weight , body mass index , and smoking cessation ( with biochemical validation ) at 4 and 12 months . Results : Favourable differences were recorded in the intervention group for dietary fat intake , regular exercise , and cigarettes smoked per day at 4 and 12 months . Systolic blood pressure was reduced to a greater extent in the intervention group at 4 but not at 12 months No differences were found between groups in changes in total serum cholesterol concentration , weight , body mass index , diastolic pressure , or smoking cessation . Conclusions : Brief behavioural counselling by practice nurses led to improvements in healthy behaviour . More extended counselling to help patients sustain and build on behaviour changes may be required before differences in biological risk factors emerge",
"OBJECTIVES 1 . To compare a patient-centred , self-directive intervention with conventional care ; 2 . To evaluate longitudinal within-group changes of coronary heart disease risk . METHODS Risk factor changes were evaluated in 110 men with high coronary heart disease risk attending a one year intervention study in general practice . The 22 participating general practice centres were r and omly allocated to follow either a patient-centred , self-directive intervention or a conventional approach . RESULTS No significant between-group differences were found in any single risk factor or in the combined risk of coronary heart disease . The improvement of total risk from screening time to conclusion of the study corresponded with changes of relative risks of CHD to 0.64 ( 95 % CI : 0.54 - 0.77 ) and 0.65 ( 0.54 - 0.77 ) in the patient-centred , self-directive and the conventional care group respectively ( p < 0.0001 in both groups ) . CONCLUSION Everyday general practice clinical work seems as efficacious as a specific intervention method based on currently advocated behaviour change principles",
"Objective To evaluate the performance of the QRISK2 - 2011 score for predicting the 10 year risk of cardiovascular disease in an independent UK cohort of patients from general practice and to compare it with earlier versions of the model and a National Institute for Health and Clinical Excellence version of the Framingham equation . Design Prospect i ve cohort study to vali date a cardiovascular risk score with routinely collected data between June 1994 and June 2008 . Setting 364 practice s from the United Kingdom contributing to The Health Improvement Network ( THIN ) data base . Participants Two million patients aged 30 to 84 years ( 11.8 million person years ) with 93 564 cardiovascular events . Main outcome measure First diagnosis of cardiovascular disease ( myocardial infa rct ion , angina , coronary heart disease , stroke , and transient ischaemic attack ) recorded in general practice records . Results Results from this independent and external validation of QRISK2 - 2011 indicate good performance data when compared with the NICE version of the Framingham equation . QRISK2 - 2011 had better ability to identify those at high risk of developing cardiovascular disease than did the NICE Framingham equation . QRISK2 - 2011 is well calibrated , with reasonable agreement between observed and predicted outcomes , whereas the NICE Framingham equation seems to consistently over-predict risk in men by about 5 % and shows poor calibration in women . Conclusions QRISK2 - 2011 seems to be a useful model , with good discriminative and calibration properties when compared with the NICE version of the Framingham equation . Furthermore , based on current high risk thresholds , concerns exist on the clinical usefulness of the NICE version of the Framingham equation for identifying women at high risk of developing cardiovascular disease . At current thresholds the NICE version of the Framingham equation has no clinical benefit in either men or women",
"Many published papers include large numbers of significance tests . These may be difficult to interpret because if we go on testing long enough we will inevitably find something which is “ significant . ” We must beware of attaching too much importance to a lone significant result among a mass of non-significant ones . It may be the one in 20 which we expect by chance alone . Lee et al simulated a clinical trial of the treatment of coronary artery disease by allocating 1073 patient records from past cases into two “ treatment ” groups at r and om.1 They then analysed the outcome as if it were a genuine trial of two treatments . The analysis was quite detailed and thorough . As we would expect , it failed to show any significant difference in survival between those patients allocated to the two treatments . Patients were then subdivided by two variables which affect prognosis , the number of diseased coronary vessels and whether the left ventricular contraction pattern was normal or abnormal . A significant difference in survival between the two “ treatment ” groups was found in those patients with three diseased vessels ( the maximum ) and abnormal ventricular contraction . As this would be the subset of patients with the worst prognosis , the finding would be easy to account for by saying that the superior “ treatment ”",
"OBJECTIVE To evaluate the impact of a low-cost nutritional intervention in changing the lifestyle of adults . DESIGN R and omised clinical trial . SETTING Primary health-care centre in São José do Rio Preto , São Paulo State , Brazil . SUBJECTS We r and omly assigned 104 adults ( 83 women and 21 men aged 30 - 65 years , body mass index 24 - 35 kg m(-2 ) , non-diabetic ) into two groups : nutrition counselling and control . Each subject in the intervention group received three individualised nutritional counselling sessions during the first 6 months aim ed at increasing intakes of fruits , vegetables and olive oil , reducing saturated fat and improving physical activity . Body composition , biochemical indicators and lifestyle were assessed at baseline and at 6 months and 1 year in both groups . RESULTS After 6 months of follow-up , body weight , waist circumference , diastolic blood pressure , fasting blood glucose , total and low-density lipoprotein cholesterol , total and saturated fat , and dietary energy and cholesterol levels showed a more significant decrease among subjects in the intervention group than in the control group ( P reduced intake of saturated fat and increased intakes of fruits , vegetables , fibre and olive oil ( P low-cost nutritional intervention programme improved serum lipids profile and weight control , and appeared to be feasible for use at a primary health-care centre in a developing country ",
"Objective To assess whether non- clinical staff can effectively manage people at high risk of cardiovascular disease using digital health technologies . Design Pragmatic , multicentre , r and omised controlled trial . Setting 42 general practice s in three areas of Engl and . Participants Between 3 December 2012 and 23 July 2013 we recruited 641 adults aged 40 to 74 years with a 10 year cardiovascular disease risk of 20 % or more , no previous cardiovascular event , at least one modifiable risk factor ( systolic blood pressure ≥140 mm Hg , body mass index ≥30 , current smoker ) , and access to a telephone , the internet , and email . Participants were individually allocated to intervention ( n=325 ) or control ( n=316 ) groups using automated r and omisation stratified by site , minimised by practice and baseline risk score . Interventions Intervention was the Healthlines service ( alongside usual care ) , comprising regular telephone calls from trained lay health advisors following scripts generated by interactive software . Advisors facilitated self management by supporting participants to use online re sources to reduce risk factors , and sought to optimise drug use , improve treatment adherence , and encourage healthier lifestyles . The control group comprised usual care alone . Main outcome measures The primary outcome was the proportion of participants responding to treatment , defined as maintaining or reducing their cardiovascular risk after 12 months . Outcomes were collected six and 12 months after r and omisation and analysed masked . Participants were not masked . Results 50 % ( 148/295 ) of participants in the intervention group responded to treatment compared with 43 % ( 124/291 ) in the control group ( adjusted odds ratio 1.3 , 95 % confidence interval 1.0 to 1.9 ; number needed to treat=13 ) ; a difference possibly due to chance ( P=0.08 ) . The intervention was associated with reductions in blood pressure ( difference in mean systolic −2.7 mm Hg ( 95 % confidence interval −4.7 to −0.6 mm Hg ) , mean diastolic −2.8 ( −4.0 to −1.6 mm Hg ) ; weight −1.0 kg ( −1.8 to −0.3 kg ) , and body mass index −0.4 ( −0.6 to −0.1 ) but not cholesterol −0.1 ( −0.2 to 0.0 ) , smoking status ( adjusted odds ratio 0.4 , 0.2 to 1.0 ) , or overall cardiovascular risk as a continuous measure ( −0.4 , −1.2 to 0.3 ) ) . The intervention was associated with improvements in diet , physical activity , drug adherence , and satisfaction with access to care , treatment received , and care coordination . One serious related adverse event occurred , when a participant was admitted to hospital with low blood pressure . Conclusions This evidence based telehealth approach was associated with small clinical benefits for a minority of people with high cardiovascular risk , and there was no overall improvement in average risk . The Healthlines service was , however , associated with improvements in some risk behaviours , and in perceptions of support and access to care . Trial registration Current Controlled Trials IS RCT N 27508731",
"R and omised controlled trials are widely accepted as the most reliable method of determining effectiveness , but most trials have evaluated the effects of a single intervention such as a drug . Recognition is increasing that other , non-pharmacological interventions should also be rigorously evaluated.1 - 3 This paper examines the design and execution of research required to address the additional problems result ing from evaluation of complex interventions —that is , those “ made up of various interconnecting parts.”4 The issues dealt with are discussed in a longer Medical Research Council paper ( www.mrc.ac.uk/complex_packages.html ) . We focus on r and omised trials but believe that this approach could be adapted to other design s when they are more appropriate . # # # # Summary points Complex interventions are those that include several components The evaluation of complex interventions is difficult because of problems of developing , identifying , documenting , and reproducing the intervention A phased approach to the development and evaluation of complex interventions is proposed to help research ers define clearly where they are in the research process Evaluation of complex interventions requires use of qualitative and quantitative evidence There are specific difficulties in defining , developing , documenting , and reproducing complex interventions that are subject to more variation than a drug . A typical example would be the design of a trial to evaluate the benefits of specialist stroke units . Such a trial would have to consider the expertise of various health professionals as well as investigations , drugs , treatment guidelines , and arrangements for discharge and follow up . Stroke units may also vary in terms of organisation , management , and skill mix . The active components of the stroke unit may be difficult to specify , making it difficult to replicate the intervention . The box gives other examples of complex interventions . # # # # Examples of complex interventions Service delivery and organisation : Stroke units Hospital at home Interventions directed at health professionals ' behaviour : Strategies for implementing guidelines Computerised decision support Community interventions : Community",
"BACKGROUND This study describes a general- practice -based high-risk cardiovascular prevention approach in Maastricht , The Netherl and s ( 1999 - 2003 ) . The intervention consisted of a complete registration of risk factors , optimization of medical treatment and health counseling on high fat consumption , smoking and physical inactivity . METHODS Behavioral effects were assessed in a trial , r and omization by practice and usual care as control . Vali date d question naires were completed by 1300 patients at baseline , 1174 after 4 months ( 90.3 % ) and 1046 ( 80.5 % ) after 18 months . RESULTS After 4 months , intention-to-treat analyses revealed a decrease in saturated fat intake of 1.3 points ( scale ranging from 7 to 30 points , p=0.000 ) . This was partly sustained after 18 months ( -0.5 points , p=0.014 ) . After 18 months , obese intervention patients were more likely to be sufficiently physically active than their control counterparts ( OR=1.90 , p=0.023 ) . No intervention effects were found for smoking . CONCLUSION Given the multiple factor and multiple component high-risk approach , the intervention had modest effects on only some of the behavioral risk factors addressed . Process data showed that the registration of risk factors and the optimization of medical treatment were only partly implemented , that the health counseling component could be further improved and that the intervention could benefit from additional health promoting strategies"
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BACKGROUND A wide array of instruments are available for non-invasive thoracic kyphosis measurement . Guidelines for selecting outcome measures for use in clinical and research practice recommend that properties such as validity and reliability are considered . This systematic review reports on the reliability and validity of non-invasive methods for measuring thoracic kyphosis . METHODS A systematic search of 11 electronic data bases located studies assessing reliability and /or validity of non-invasive thoracic kyphosis measurement techniques . Two independent review ers used a critical appraisal tool to assess the quality of retrieved studies . Data was extracted by the primary review er . The results were synthesized qualitatively using a level of evidence approach . RESULTS 27 studies satisfied the eligibility criteria and were included in the review . The reliability , validity and both reliability and validity were investigated by sixteen , two and nine studies respectively . 17/27 studies were deemed to be of high quality . In total , 15 methods of thoracic kyphosis were evaluated in retrieved studies . All investigated methods showed high ( ICC ≥ .7 ) to very high ( ICC ≥ .9 ) levels of reliability . The validity of the methods ranged from low to very high . CONCLUSION The strongest levels of evidence for reliability exists in support of the Debrunner kyphometer , Spinal Mouse and Flexicurve index , and for validity supports the arcometer and Flexicurve index . Further reliability and validity studies are required to strengthen the level of evidence for the remaining methods of measurement . This should be addressed by future research
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"Study Design . A reliability study was performed using repeated r and om measurements involving three observers , 26 subjects and three instruments . Objectives . To determine the most reliable , cost‐effective , noninvasive , and clinical ly feasible method of measuring spinal kyphosis . Summary of Background Data . The most clinical ly useful , noninvasive and reliable method of measuring postural deformity in spinal osteoporosis ( kyphosis ) remains unqualified . Despite traditional use of costly , invasive roentgenographs for the evaluation of spinal kyphosis , the reliability of this method remains question able . Methods . Twenty‐six postmenopausal women with known bone mineral density and a diagnosis of osteoporosis were recruited from the Osteoporosis Program at Women 's College Hospital , Toronto , Canada . Noninvasive measurements of thoracic kyphosis were obtained by three trained examiners using the DeBrunner 's kyphometer and the flexicurve ruler . The intrarater and interrater reliability of and between each method was compared , using roentgenographic films obtained in the sagittal plane . Spinal posture was classified according to the method of Itoi ( 1990 ) . Statistical computations were performed using SAS statistical software . Results . Consistent measurements were obtained with the DeBrunner 's kyphometer and the flexicurve ruler by each observer , according to the results of critical two‐way analysis of variance ( Intraclass Correlation Coefficient 2,1 ) . Measurements in two subgroups , healthy backs ( n = 11 ) and rounded backs ( n= 13 ) , showed consistent use of each noninvasive instrument with some examiner preference for specific tools . There was marginally better intrarater and interrater reliability using the DeBrunner 's kyphometer compared with that obtained with the flexicurve ruler . Two‐way analysis of variance ( Intraclass Correlation Coefficient 2,1 ) of collapsed data showed no significant difference in the reliability of the kyphometer , flexicurve ruler , or roentgenographs in the measurement of thoracic kyphosis . Conclusions . The flexicurve ruler and DeBrunner 's kyphometer had the closest agreement in the measurement of spinal kyphosis . The kyphometer demonstrated the least variation in intrarater and interrater reliability when compared with the flexicurve ruler and roentgenographs . The flexicurve ruler permits qualitative assessment of posture , however , and is the most costeffective instrument . The results of this study challenge the traditional belief that roentgenographic analysis is the best method for evaluating spinal kyphosis . The DeBrunner 's kyphometer and flexible ruler may represent viable , cost‐effective and noninvasive alternatives to roentgenographic evaluation of spinal kyphosis",
"The Debrunner kyphometer is an accepted tool for detecting and evaluating thoracic kyphosis . This prospect i ve study was conducted to create a mathematical formula that provides , with high approximation , the roentgenographic angle of thoracic kyphosis ( T4-T12 ) using only the kyphometer . Several clinical ( kyphometer value , age , and sex ) and radiographic ( Cobb angle [ T4-T12 ] ) parameters from 90 consecutively screened adolescents ( 44 male and 46 female ) were correlated using simple and multiple linear regression analyses . The reliability of measurement using the Debrunner kyphometer was high . The kyphometer value was strongly correlated with the roentgenographically measured thoracic Cobb angle ( simple linear regression analysis ; probability range , 0.0026 to 0.0002 ) . There was no correlation between age or sex and thoracic kyphosis . The predicted kyphosis angle using the kyphometer and the mathematic formula was 44.66 degrees + /- 2.68 degrees , ( range 27 to 62 degrees ) , and the real roentgenographic kyphosis angle was 47.5 degrees + /- 3.53 degrees , ( range , 24 to 70 degrees ) . The kyphometer and formula were more reliable and accurate when kyphosis less than 50 degrees was measured . In this study , the authors constructed a mathematical formula that accurately provides the roentgenographic T4-T12 kyphosis angle in adolescents using only the Debrunner kyphometer with a deviation of less than 3 degrees . The authors recommend that all physicians engaged in kyphosis screening programs use the kyphometer combined with the recently constructed simple mathematic formula . This method will reduce the cost of school screening programs , overdiagnoses , and unnecessary exposure of adolescents to irradiation",
"Background Clinical sagittal plane assessment of the thoracic kyphosis angle is considered an essential component of the postural examination of patients presenting with upper body pain syndromes . Cervical headaches and conditions involving the shoulder , such as subacromial pain syndrome , have all been associated with an increase in the thoracic kyphosis . Concomitantly a decrease in the thoracic kyphosis as a result of a stretching and strengthening rehabilitation programme is believed to be associated with a reduction in symptoms and pain and improvement in function . Clinicians generally measure the sagittal plane kyphosis angle visually . There is no certainty that this method is reliable or is capable of measuring angular changes over time or in response to intervention . As such a simple and reliable clinical method of measuring the thoracic kyphosis would enable clinicians to record this information . The aim of this investigation was to determine the intra-tester reliability of measuring the thoracic kyphosis angle using a clinical method Methods Measurements were made in 45 subjects with and 45 subjects without upper body symptoms . Measurements were made with the subjects in relaxed st and ing . Two gravity dependent inclinometers were used to measure the kyphosis . The first was placed over the region of the 1st and 2nd thoracic spinous processes . The other , over the region of the 12th thoracic and 1st lumbar spinous processes . The angle produced by each inclinometer was measured 3 times in succession . Each set of 3 measurements was made on two occasions ( separated by a minimum of 30 minutes and additional data collection involving 46 further measurements of posture and movement on the same and an additional subject before the thoracic kyphosis measurements were re-measured ) by one rater . The reliability of the measurements was analyzed using 2-way ANOVA intraclass correlation coefficients ( ICC ) , 95 % confidence intervals ( CI ) and st and ard error of measurement ( SEM ) for precision , for a single measurement [ ICC(single ) ] and the average of 3 measures [ ICC(average ) ] . The assessor remained ' blinded ' to data input and the measurements were staggered to reduce examiner bias . Results The measurement of the thoracic kyphosis as used in this investigation was found to have excellent intra-rater reliability for both subjects with and without symptoms . The ICC(single ) results for the subjects without symptoms were , .95 ; ( 95 % CI .91-.97 ) . The corresponding ICC(average ) results were ; .97 ; ( 95 % CI .95-.99 ) . The results for the subjects with symptoms were ; 93 ; ( 95 % CI .88-.96 ) , for ICC(single ) and for ICC(average ) ; .97 ; ( 95 % CI .94-.98 ) . The SEM results for subjects without and with symptoms were 1.0 ° and 1.7 ° , respectively . Conclusions The findings of this immediate test-retest reliability study suggest that the clinical measurement of the thoracic kyphosis using gravity dependent inclinometers demonstrates excellent intra-rater reliability . Additional research is required to determine the inter-rater reliability of this method .Trial registration National Research Register :",
"There is an increasing awareness of the risks and dangers of exposure to radiation associated with repeated radiographic assessment of spinal curvature and spinal movements . As such , attempts are continuously being made to develop skin-surface devices for use in examining the progression and response to treatment of various spinal disorders . However , the reliability and validity of measurements recorded with such devices must be established before they can be recommended for use in the research or clinical environment . The aim of this study was to examine the reliability of measurements using a newly developed skin-surface device , the Spinal Mouse . Twenty healthy volunteers ( mean age 41±12 years , nine males , 11 females ) took part . On 2 separate days , spinal curvature was measured with the Spinal Mouse during st and ing , full flexion , and full extension ( each three times by each of two examiners ) . Paired t-tests , intraclass correlation coefficients ( ICC ) , and st and ard errors of measurement ( SEM ) with 95 % confidence intervals were used to characterise between-day and interexaminer reliability for : st and ing sacral angle , lumbar lordosis , thoracic kyphosis , and ranges of motion ( flexion , extension ) of the thoracic spine , lumbar spine , hips , and trunk . The between-day reliability for segmental ranges of flexion was also determined for each motion segment from T1 - 2 to L5-S1 . The majority of parameters measured for the ‘ global regions ’ ( thoracic , lumbar , or hips ) showed good between-day reliability . Depending on the parameter of interest , between-day ICCs ranged from 0.67 to 0.92 for examiner 1 ( average 0.82 ) and 0.57 to 0.95 for examiner 2 ( average 0.83 ) ; for 70 % of the parameters measured , the ICCs were greater than 0.8 and generally highest for the lumbar spine and whole trunk measures . For lumbar spine range of flexion , the SEM was approximately 3 ° . The ICCs were also good for the interexaminer comparisons , ranging from 0.62 to 0.93 on day 1 ( average 0.81 ) and 0.70 to 0.94 on day 2 ( average 0.86 ) , although small systematic differences were sometimes observed in their mean values . The latter were still evident even if both examiners used the same skin markings . For segmental ranges of flexion , the ICCs varied between vertebral levels but overall were lower than for the global measures ( average for all levels in all analyses , ICC 0.6 ) . For each examiner , the average between-day SEM over all vertebral levels was approximately 2 ° . For ‘ global ’ regions of the spine , the Spinal Mouse delivered consistently reliable values for st and ing curvatures and ranges of motion which compared well with those reported in the literature . This suggests that the device can be reliably implemented for in vivo studies of the sagittal profile and range of motion of the spine . As might be expected for the smaller angles being measured , the segmental ranges of flexion showed lower reliability . Their usefulness with regard to the interpretation of individual results and the detection of ‘ real change ’ on an individual basis thus remains question able . Nonetheless , the group mean values showed few between-day differences , suggesting that the device may still be of use in providing clinical ly interesting data on segmental motion when examining groups of individuals with a given spinal pathology or undergoing some type of intervention",
"ObjectiveS everal measures can quantify thoracic kyphosis from radiographs , yet their suitability for people with osteoporosis remains uncertain . The aim of this study was to examine the validity and reliability of the vertebral centroid and Cobb angles in people with osteoporosis . Design and patients Lateral radiographs of the thoracic spine were captured in 31 elderly women with osteoporosis . Thoracic kyphosis was measured globally ( T1–T12 ) and regionally ( T4–T9 ) using Cobb and vertebral centroid angles . Multisegmental curvature was also measured by fitting polynomial functions to the thoracic curvature profile . Canonical and Pearson correlations were used to examine correspondence ; agreement between measures was examined with linear regression . Results Moderate to high intra- and inter-rater reliability was achieved ( SEM = 0.9–4.0 ° ) . Concurrent validity of the simple measures was established against multisegmental curvature ( r = 0.88–0.98 ) . Strong association was observed between the Cobb and centroid angles globally ( r = 0.84 ) and regionally ( r = 0.83 ) . Correspondence between measures was moderate for the Cobb method r = 0.72 ) , yet stronger for the centroid method ( r = 0.80 ) . The Cobb angle was 20 % greater for regional measures due to the influence of endplate tilt . Conclusions Regional Cobb and centroid angles are valid and reliable measures of thoracic kyphosis in people with osteoporosis . However , the Cobb angle is biased by endplate tilt , suggesting that the centroid angle is more appropriate for this population",
"We report the development and validation of an osteoporosis-targeted quality of life question naire to measure the impact of the disease in the general population . From multiple focus groups with women with osteoporosis , healthy women at risk for osteoporosis , spouses and relatives of women with osteoporosis , and health care providers , we identified over 300 potential items related to the disease . A lengthy question naire incorporated these items and was administered to a second large study cohort of 222 women with clinical osteoporosis ( history of fracture , significant height loss , and /or kyphosis ) ; 101 women with known low bone mineral density levels that would categorize them as osteoporotic but who had not yet shown obvious physical manifestations of the disease ; and 142 women with other conditions ( such as arthritis , cancer , depression ) expected to also have an impact on quality of life . Final items from among the original 300 were chosen for their demonstrated relationship with osteoporosis as measured by clinical manifestations and low bone density and with quality of life measured by a st and ard generic question naire , the SF-36 . The final question naire contains 26 scored items in three domains-physical activity , adaptations , and fears- and six nonscored questions relating to osteoporotic changes and diagnosis . This instrument is unique among osteoporosis-targeted question naires in that it attempts to measure the total impact of the disease on quality of life within a population at a single point in time",
"A considerable number of instruments have been described for noninvasive measurements of the sagittal configuration and mobility of the thoracolumbar spine . With Debrunner 's kyphometer , it is possible to obtain this information in approximately 1 minute in a clinical setting . A minor modification of the kyphometer to increase its range of measurement of lumbar extension is described . Repeatability of measurements with the instrument was studied on 31 healthy individuals in a r and omized cross-over model . In another study , ten individuals were examined ten times each by the same investigator within 3 weeks . These studies showed good reproducibility for measurements with the kyphometer . The importance of st and ardized instructions for measurement procedures is emphasized . The statistical approach to repeatability of measurements is discussed",
"Location of spinal levels by palpation is an essential part of physiotherapy assessment and treatment of spinal musculoskeletal conditions . This study aim ed to ( i ) investigate the reproducibility and repeatability of three groups of physiotherapists in locating three r and omly selected spinal levels by palpation , ( ii ) explore whether these groups were palpating similar points at each level , and ( iii ) investigate whether there were differences in palpation across the spinal levels tested . Reproducibility was estimated using a convenience sample of 30 physiotherapists : 13 undergraduate students , 10 clinicians , and seven manual therapists ( MTs ) . Repeatability was investigated using six physiotherapists ( two students , two clinicians and two MTs ) . Each therapist palpated the spinous processes ( C5 , T6 , L5 ) once for reproducibility , and 10 times for repeatability , on each asymptomatic model . The skin overlying the spinal levels was marked with an invisible pen . Using an ultra-violet light , marks were transcribed onto transparent plastic strips for analysis , and the distances were measured with an electronic caliper . Repeated measures analyses of variance ( ANOVA ) indicated poor reproducibility across therapists at all spinal levels ( F=18.43 , P=0.001 ) , but good repeatability within therapists ( F=2.09 , P=0.161 ) . Students produced different mean locations of their palpatory marks from the other two groups in two spinal levels . Clinicians and MTs were more reproducible than students , and located similar levels . Palpation of L5 spinous process presented the most difficulty , for all groups . Further research is needed to compare different methods of palpation and explore whether reproducibility can be improved",
"PURPOSE The purpose of this study was to investigate the reliability of photogrammetry in the measurement of the postural deviations in individuals with idiopathic scoliosis . METHODS Twenty participants with scoliosis ( 17 women and three men ) , with a mean age of 23.1 ± 9 yrs , were photographed from the posterior and lateral views . The postural aspects were measured with CorelDRAW software . RESULTS High inter-rater and test-retest reliability indices were found . It was observed that with more severity of scoliosis , greater were the variations between the thoracic kyphosis and lumbar lordosis measures obtained by the same examiner from the left lateral view photographs . A greater body mass index ( BMI ) was associated with greater variability of the trunk rotation measures obtained by two independent examiners from the right , lateral view ( r = 0.656 ; p = 0.002 ) . The severity of scoliosis was also associated with greater inter-rater variability measures of trunk rotation obtained from the left , lateral view ( r = 0.483 ; p = 0.036 ) . CONCLUSIONS Photogrammetry demonstrated to be a reliable method for the measurement of postural deviations from the posterior and lateral views of individuals with idiopathic scoliosis and could be complementarily employed for the assessment procedures , which could reduce the number of X-rays used for the follow-up assessment s of these individuals"
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41172666-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Children and adolescents with congenital heart disease often have alterations in their exercise capacity that can be evaluated by various functional testing . OBJECTIVE To evaluate the functional capacity of children and adolescents with congenital heart disease ( CHD ) with systematic review and meta-analyses . METHODS The review included observational studies , data from the first evaluation of r and omized clinical trials or observational follow-up periods after clinical trials which evaluated functional capacity by cardiopulmonary exercise test , stress testing , six-minute walk test or step test , in children and adolescents with CHD , aged between six and 18 years , and comparisons with healthy controls in the same age group . The quantitative assessment was performed by meta- analysis , by comparing the maximal oxygen consumption ( VO2max ) of children and adolescents with CHD and respective control groups . RESULTS Twenty-five of 2.683 studies identified in the search met the inclusion criteria . The VO2max measurement showed that patients with CHD have a decrease of 9.31 ml/Kg/min ( 95 % CI . -12.48 to -6.13 ; I2 , 94.3 % , P for heterogeneity maximum heart rate ( HR ) reached during cardiopulmonary test and stress testing , retrieved from 18 studies , showed a HR value of -15.14 bpm ( 95 % CI . -20.97 to -9.31 ; I2 , 94.3 % , P for heterogeneity Children and adolescents with CHD have lower VO2max and HR compared to controls
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[
"This study was conducted to determine whether submaximal cardiovascular responses at a given rate of work are different in children and adults , and , if different , what mechanisms are involved and whether the differences are exercise-modality dependent . A total of 24 children , 7 to 9 yr old , and 24 adults , 18 to 26 yr old ( 12 males and 12 females in each group ) , participated in both submaximal and maximal exercise tests on both the treadmill and cycle ergometer . With the use of regression analysis , it was determined that cardiac output ( Q ) was significantly lower ( P Q in the children was compensated for by a significantly higher ( P arterial-mixed venous O2 difference to achieve the same or similar VO2 . Furthermore , heart rate and total peripheral resistance were higher and stroke volume was lower in the children vs. in the adult groups on both exercise modalities . Stroke volume at a given rate of work was closely related to left ventricular mass , with correlation coefficients ranging from r = 0.89 - 0.92 and r = 0.88 - 0.93 in the males and females , respectively . It was concluded that submaximal cardiovascular responses are different in children and adults and that these differences are related to smaller hearts and a smaller absolute amount of muscle doing a given rate of work in the children . The differences were not exercise-modality dependent",
"Background —Elevated neurohumoral activity and an abnormal cardiopulmonary response to exercise are well-established characteristics in patients after the Fontan operation . However , there have been few studies addressing cardiac autonomic nervous activity ( CANA ) in these patients . Methods and Results —We evaluated CANA in 63 post-Fontan patients and 44 controls . Cardiac parasympathetic nervous activity ( PSNA ) was estimated by heart rate ( HR ) changes after cholinergic blockade , HR variability , and arterial baroreflex sensitivity . Cardiac sympathetic nervous activity was estimated by the heart to mediastinum [123I]metaiodobenzylguanidine activity ratio ( H/M ) and the HR increase ( & Dgr;HR ) after isoproterenol infusion ( & bgr ; ) . & Dgr;HR and peak oxygen uptake ( & OV0312;o2 ) were measured by exercise test . There was no difference in & bgr ; between the Fontan group and controls . PSNA and H/M were markedly lower than in controls ( P PSNA and & bgr ; were related to & Dgr;HR ( P & OV0312;o2 was not correlated with & Dgr;HR . Neither PSNA nor H/M was associated with clinical features , including hemodynamics , type of repair , number of surgical procedures , age at Fontan operation , or follow-up period , and administration of an angiotensin-converting enzyme inhibitor did not improve the impaired CANA in these patients . Conclusions —After the Fontan procedure , postsynaptic & bgr;-sensitivity is maintained and is important in & Dgr;HR during exercise as is PSNA , although & Dgr;HR does not determine exercise capacity . The lack of a relationship between CANA and clinical features implies that , in addition to surgical damage , the Fontan circulation per se may impair CANA . Angiotensin-converting enzyme inhibitor administration does not change this abnormality",
"Aim : This prospect i ve follow‐up study investigated long‐term exercise capacity at a mean age of 10 y after neonatal arterial switch operation for transposition of the great arteries in a large group of homogeneous unselected children . Methods : 56 asymptomatic children , aged 7.9–14.3 y ( 10.5 ± 1.6 , mean ± SD ) , were examined with respect to exercise tolerance , electrocardiographic ( ECG ) response and activity of biochemical markers for myocardial injury . The protocol included st and ard electrocardiography , M‐mode and two‐dimensional echocardiography at rest , a Bruce walking treadmill test to voluntary exhaustion , and determination of cardiac troponin I and T , creatine kinase and myoglobin from venous blood sample s at rest and 4 h after exercise . Heart rate , blood‐pressure response to exercise stress and endurance time were compared with published results of age‐matched normal children . Results : 54 patients ( 96.4 % ) had normal exercise capacity ; a reduction in 2 patients was not due to cardiac disease . Heart rate and systolic blood pressure rose significantly between rest and peak exercise and did not differ from normal controls , whereas diastolic blood pressure was lower . ECG remained normal at rest and on exercise in 54 children ( 96.4 % ) . Serum values of cardiac troponin I and T , creatine kinase and myoglobin were normal at rest and after exercise in all patients",
"OBJECTIVE --To determine the effects of residual pulmonary regurgitation on exercise tolerance after complete repair of tetralogy of Fallot . DESIGN -- Prospect i ve study of symptom free patients more than five years after complete repair . Grade d exercise performance was measured with st and ard Bruce protocol . Maximal oxygen uptake and ventilatory anaerobic threshold were measured by respiratory mass spectrometry . Measurement of pulmonary regurgitant fraction was from pressure-volume loops constructed from measurements of right ventricular volume obtained from biplane angiograms and simultaneous pressures measured with a micromanometer . SETTING --Tertiary referral centre . PATIENTS --16 patients were studied . Two patients had been excluded because of residual cardiac lesions or inadequate data from cardiac catheterisation . Four were later excluded because they failed to reach a respiratory quotient of greater than 1.0 during grade d exercise . RESULTS --There was a significant negative correlation between the degree of residual regurgitation and both total duration of exercise and maximal heart rate achieved . Maximal heart rate and total duration of exercise were significantly lower in the patients than in normal controls . Patients with an abnormal maximal oxygen uptake ( less than 85 % of the predicted normal value ) had significantly greater residual pulmonary regurgitation than those in whom oxygen uptake was normal . CONCLUSIONS --Impaired exercise capacity after complete repair of tetralogy of Fallot is directly related to the degree of residual pulmonary regurgitation . These data should be taken into account when deciding the optimal timing and nature of corrective surgery",
"Abstract The purpose of the present study was to measure oxygen uptake $ $ ( \\dot VO_2 ) $ $ at the ventilatory threshold ( VT ) in patients with congenital heart disease using a progressive exercise protocol on a treadmill and to evaluate the validity and feasibility of this procedure . Eight control subjects and seventeen patients performed a maximal exercise test with breath-by-breath measurement of ventilation and gas exchange variables . VT(VE ) was determined by the change in the ventilatory equivalent for $ $ \\dot VO_2 $ $ and carbon dioxide output , VT(V-sl ) by the V-slope method , and the lactate threshold ( LT ) by the change in blood lactate concentration ; these parameters were determined in 100 % , 88 % , and 96 % of subjects , respectively . The interobserver error among three evaluators was not significant , and LT was correlated with each VT ( r=0.97 , 0.92;p=0.0001 ) and with peak $ $ \\dot VO_2 $ $ ( r=0.91;p=0.0001 ) . The VTs were correlated with each other when expressed as milliliter per minute and milliliters per kilogram per minute . It was concluded that a progressive exercise protocol on a treadmill was a feasible procedure for determining the VTs in most individuals and that VTs were valid , useful parameters for evaluating submaximal exercise tolerance in patients with congenital heart disease",
"Markedly increased pulmonary blood flow because of a relevant atrial septal defect ( ASD ) leads to impaired cardiopulmonary function during maximum exercise in adults . No comparative preoperative and postoperative data are available on the short‐term effects of shunt closure on cardiorespiratory function at peak exercise in children . Pulmonary function testing at rest and cardiopulmonary exercise testing together with haemodynamic assessment was done prospect ively in children with an ASD preoperatively and again after full recovery at 3–4 mo postoperatively and compared with a matched normal population . Sixteen children , aged 6.8–16.1 y , with a defect of 8–23 mm ( median 15 mm ) and a pulmonary/systemic flow ratio of 1.5–3.5 ( median 2.2 ) were tested and compared with 15 healthy children . Preoperatively , baseline pulmonary function parameters and exercise capacity were no different from normals . At peak exercise , patients with a shunt had increased pulmonary resistance , especially of the distal airways ( p= 0.04 ) , with a significantly larger proportion of children having a paradoxical increase in total airway resistance during exercise ( p ) . Maximum serum lactate at peak exercise was elevated ( p , maximum oxygen uptake was impaired ( p= 0.03 ) and remained so at repeat evaluation postoperatively . The same observation was made for chronotropic response to exercise",
"This study assessed the exercise tolerance and the cardiorespiratory responses to a training program by the six-minute walk test ( 6'WT ) in children with congenital heart disease ( CHD ) . Seventeen cardiac and 14 healthy children performed maximal cardiopulmonary exercise test ( CPET ) and 6'WT . Reliability of 6'WT was assessed in all subjects ( test-retest ) by Bl and -Altman plots . Cardiac subjects were r and omly divided in training ( T-CHD ) and control groups ( C-CHD ) . T-CHD underwent an individualized training exercise at the ventilatory threshold ( VT ) intensity during 12 weeks . We found that the 6'WT is a reliable and reproducible test . CHD children walked a lower distance than healthy children before training ( 472.5 + /- 18.1 vs. 548.8 + /- 7.7 m , respectively , p power output , oxygen uptake ( V.O ( 2 ) ) , and heart rate ( HR ) at the maximum and the VT levels , were significantly lower in patients ( p walking distance ( WD ) was shown in T-CHD ( 529.6 + /- 15.3 vs. 467.7 + /- 17.1 m , p power output , VO2 , HR , and V.E increased slightly ( 6 to 10 % , p > 0.05 ) at peak exercise and significantly at ventilatory threshold level ( p WD and VO2max as well as VO2 at VT were founded ( p < 0.05 ) . We concluded that the 6'WT is a useful and reliable tool in the assessment and follow-up of functional capacity during rehabilitation program in children with CHD"
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411726a2-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND The Outcome Measures in Rheumatology ( OMERACT ) initiative developed a core outcome set ( COS ) of domains to assess effectiveness of interventions for knee osteoarthritis . These domains ( pain , physical function , patient global assessment , imaging at 1 year ) should be assessed in every trial to make research evidence meaningful and comparable . We systematic ally evaluated and critically appraised the use of measurement instruments and outcome domains in prospect i ve studies evaluating patients with knee osteoarthritis undergoing total knee arthroplasty ( TKA ) and assessed their accordance with the OMERACT COS . METHODS Literature search was performed until August 26 , 2014 , in Medline and Embase . Clinical trials and prospect i ve observational studies with ≥50 participants and a follow-up of ≥1 year were included . We collected general study characteristics , comprehensive information on measurement instruments , and corresponding domains used . RESULTS This systematic review identified low accordance of used outcome domains with the OMERACT COS of domains published in 1997 . Only 4 of 100 included studies included all recommended core domains . Pain ( 85 % of studies ) and physical function ( 86 % ) were assessed frequently , whereas patient global assessment ( 21 % ) and joint imaging ( ≥1 year ; 27 % ) were rarely assessed . There was substantial heterogeneity in the use of measurement instruments ( n = 111 ) investigating TKA . CONCLUSION More efforts are required to implement the existing COS . In addition , a more consistent use of adequate measurement instruments is important to make research evidence on TKA more relevant , better comparable , and thus more useful for guideline developers and clinical decision makers
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"BACKGROUND An important factor in the functional results after total knee arthroplasty is the achieved maximal flexion . The main purpose of this study was to compare the maximal knee flexion one year after surgery in patients who received either the bicruciate substituting knee system or the conventional posterior stabilized system . METHODS In a prospect i ve r and omized controlled trial , 124 patients presenting with osteoarthritis received the bicruciate substituting or the conventional posterior stabilized prosthesis . The primary outcome was the maximum flexion angle at one year postoperatively on a lateral radiograph made with the supine patient using manual force to bend the knee . Secondary outcomes were active flexion ( lying and st and ing ) , the Knee Society Score , the Patella Scoring System score , the University of California Los Angeles score , the number and type of adverse device effects , and visual analog scale satisfaction up to two years postoperatively . The outcome measures of both groups were compared using one-sided t tests and non-parametric alternatives , with a significance level of p in maximal flexion on radiographs and in active flexion at baseline . The median maximal flexion on radiographs was 127 ° ( range , 83 ° to 150 ° ) for the bicruciate substituting group and 125 ° ( range , 74 ° to 145 ° ) for the conventional posterior stabilized group . The two groups showed comparable two-year results with respect to the Knee Society Score , the Patella Scoring System , the University of California Los Angeles score , and visual analog scale satisfaction . In the bicruciate substituting group , forty-one adverse device effects in twenty-six patients were reported , including three total system revisions and fourteen manipulations under anesthesia , compared with the conventional posterior stabilized group , in which sixteen adverse device effects were observed in thirteen patients , including six manipulations under anesthesia ( p = 0.012 ) . CONCLUSIONS Patients who receive a bicruciate substituting system compared with those who receive a conventional posterior stabilized system have comparable knee flexion characteristics and clinical and functional outcomes but more complications by two years after total knee arthroplasty . LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence",
"Purpose The presence of anterior knee pain remains one of the major complaints following total knee arthroplasty ( TKA ) . Since the introduction of the mobile TKA , many studies have been performed and only a few show a slight advantage for the mobile . In our short-term follow-up study , we found less anterior knee pain in the posterior stabilized mobile knees compared to the posterior stabilized knees . The concept of self-alignment and the results from our short-term study led us to form the hypothesis that the posterior stabilized mobile knee leads to a lower incidence of anterior knee pain compared to the posterior stabilized fixed knee . This study was design ed to see whether this difference remains after 7.9 years in the follow-up . A secondary line of enquiry was to see whether one was superior to the other regarding pain , function , quality of life and survival . Methods This current report is a 6–10-year ( median 7.9 years ) follow-up study of the remaining 69 patients with a cemented three-component TKA for osteoarthritis in a prospect i ve , r and omized , double-blinded clinical trial . Results In the posterior stabilized group , five of the 40 knees ( 13 % ) versus five of the 29 posterior stabilized mobile group ( 17 % ) experienced anterior knee pain . No differences were observed with regard to ROM , VAS , Oxford 12-item knee question naire , SF-36 , HSS patella , Kujala or the AKSS score . Patients with anterior knee pain reported more pain , lower levels of the AKSS , HSS patella and the Kujala scores than the patients without anterior knee pain . Conclusion In the current clinical practice , the appearance of anterior knee pain persists as a problem ; simply changing to a mobile bearing does not seem to be the solution . The posterior stabilized mobile total knee did not sustain the advantage of less anterior knee pain , compared with the posterior stabilized fixed total knee arthroplasty . Level of evidence Therapeutic study , Level II",
"Background Kinematically aligned TKA restores function by aligning the femoral and tibial components to the normal or prearthritic joint lines of the knee . However , aligning the components to the joint lines of the normal knee also aligns the tibial component in varus , creating concern that varus alignment might result in poor function and early catastrophic failure . Questions / Purpose sWe therefore determined whether function and the incidence of catastrophic failure were different when the tibial component , knee , and limb alignment were in a specified normal range , varus outlier , or valgus outlier . Methods We prospect ively followed all 198 patients ( 214 knees ) who underwent TKAs between February and October 2008 . We treated each knee in this cohort of patients with a kinematically aligned , cruciate-retaining prosthesis implanted using patient-specific guides . From a long-leg scanogram , we measured and categorized alignment of the tibial component as in range ( ≤ 0 ° ) or a varus outlier ( > 0 ° ) , alignment of the knee as in range ( between −2.5 ° to −7.4 ° valgus ) or a varus ( > −2.5 ° ) or valgus ( 3 ° ) or valgus ( Oxford Knee Score and WOMAC ™ score , and reported catastrophic failure as the incidence of revision attributable to loosening , wear , and instability of the femoral or tibial components . The minimum followup was 31 months ( mean , 38 months ; range , 31–43 months ) . Results The mean Oxford Knee Score of 43 and WOMAC ™ score of 92 were similar between the three alignment categories . The incidence of catastrophic failure in each alignment category was zero . Conclusions Kinematically aligned TKA restores function without catastrophic failure regardless of the alignment category . Because 75 % of patients had their tibial component categorized as a varus outlier and also had high function and a zero incidence of catastrophic failure , the concern that kinematic alignment compromises function and places the components at a high risk for catastrophic failure is unfounded and should be of interest to surgeons committed to cutting the tibia perpendicular to the mechanical axis of the tibia . Level of Evidence Level IV , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"Introduction The Genesis II knee system incorporates 3 ° of external rotation into the femoral component and the femoral component is implanted in neutral rotation to the femur . The purpose of this study was to compare patellar tracking of the Genesis II knee system with that of the Vanguard knee system , in which the femoral component is routinely implanted in a 3 ° externally rotated position to the posterior condylar axis ( PCA ) of the femur . Material s and methods One hundred consecutive knees scheduled to undergo total knee arthroplasty ( TKA ) were enrolled . Fifty knees underwent TKA with the posterior-stabilized ( PS ) Genesis II prosthesis and 50 knees underwent TKA with the PS Vanguard prosthesis . Rotation of the femoral component was calculated by measuring the acute angle between the transepicondylar axis ( TEA ) and the PCA on axial computed tomography ( CT ) images . The postoperative patellar tilt and displacement were compared between groups . The range of motion and Knee Society scores were also compared . Results Forty-eight knees in each group were followed up for 2 years . There was no difference in the angle between the PCA and the TEA on postoperative CT scans between the two design s. There was also no difference in patellar tracking between groups . Both the Genesis II and Vanguard knee systems showed good clinical results at 2 years postoperatively . Conclusion The patellar tracking of the Genesis II prosthesis was comparable to that of the Vanguard prosthesis . Level of evidence Prospect i ve cohort study , Level II",
"A total knee arthroplasty can be completed using two techniques ; measured resection or gap balancing . A prospect i ve blinded r and omized controlled trial was completed with 103 patients r and omized to measured resection ( n = 52 ) or gap balancing ( n = 51 ) . Primary outcome measure was femoral component rotation . Secondary outcome measures were joint-line change , gap symmetry and function and quality -of-life outcomes . Gap balancing result ed in a significantly raised joint-line compared to measured resection . Gap symmetry was significantly better using gap balancing . Functional outcomes and quality -of-life were not significantly different at 24 months . Using computer navigation , gap balancing significantly raises the joint-line in order to improve gap symmetry . This does not result in a clinical difference in function or quality of life at 24 months",
"Objectives The aim of this study was to identify threshold values in the pre- and post-operative Oxford knee score ( OKS ) , and change in the score for differing levels of patient satisfaction with their total knee replacement ( TKR ) . Methods We prospect ively collected pre-operative and 1-year post-operative OKS for 2392 patients undergoing a TKR . Patient satisfaction was categorically assessed , according to whether they were : very satisfied , satisfied , neutral , and unsatisfied . Receiver operating characteristic curve analysis was used to identify thresholds in the OKS score that identified each level of patient satisfaction . Results The post-operative OKS was the most accurate predictor of the level of patient satisfaction ( area under the curve = 0.86 ) . Very satisfied patients had a threshold value in the post-operative OKS of ≥36 , which decreased to ≥27 points for satisfied patients , and further still to ≤25 for unsatisfied patients . Conclusion The threshold values , we have identified for the different levels of satisfaction using the post-operative OKS , which is the most accurate predictor , can be used to predict level of patient satisfaction and give quantification of the OKS",
"Background We sought to determine whether socio-economic status ( SES ) is an independent predictor of outcome following total knee ( TKR ) and hip ( THR ) replacement in Australians . Methods In this prospect i ve cohort study , we included patients undergoing TKR and THR in a public hospital in whom baseline and 12-month follow-up data were available . SES was determined using the Australian Bureau of Statistics ‘ Index of Relative Advantage and Disadvantage ’ . Other independent variables included patients ’ demographics , comorbidities and procedure-related variables . Outcome measures were the International Knee Society Score and Harris Hip Score pain and function subscales , and the Short Form Health Survey ( SF-12 ) physical and mental component scores . Results Among 1,016 patients undergoing TKR and 835 patients undergoing THR , in multiple regression analysis , SES score was not independently associated with pain and functional outcomes . Female sex , older age , being a non-English speaker , higher body mass index and presence of comorbidities were associated with greater post-operative pain and poorer functional outcomes following arthroplasty . Better baseline function , physical and mental health , and lower baseline level of pain were associated with better outcomes at 12 months . In univariate analysis , for TKR , the improvement in SF-12 mental health score post arthroplasty was greater in patients of lower SES ( 3.8 ± 12.9 versus 1.5 ± 12.2 , p = 0.008 ) , with a statistically significant inverse association between SES score and post-operative SF-12 mental health score in linear regression analysis ( coefficient−0.28 , 95 % CI : −0.52 to −0.04 , p = 0.02 ) . Conclusions When adjustments are made for other covariates , SES is not an independent predictor of pain and functional outcome following large joint arthroplasty in Australian patients . However , relative to baseline , patients in lower socioeconomic groups are likely to have greater mental health benefits with TKR than more privileged patients . Large joint arthroplasty should be made accessible to patients of all SES",
"Introduction The surgical wound of total knee arthroplasty ( TKA ) needs continuous flexion and extension movement . Silicone gel treatment is widely used to treat hypertrophic scars and keloids since it is easily applied and prevents scar pain and itching . The aim of this study was to evaluate the clinical efficacy and safety of silicone gel applied to surgical scars of TKA on postoperative scar pain and pruritus . Material s and methods One hundred TKAs were r and omized into a silicone gel group ( silicone gel was applied to the wound after stitch-out for 1 month ) or a placebo group . The postoperative scar pain and pruritus were evaluated with the use of a visual analog scale ( VAS ) at postoperative 3 months , 6 months and 1 year . Scar assessment was done using the Vancouver scar scale by evaluating scar pigmentation , vascularity , pliability , and height . Results Although silicone gel group showed better pigmentation and height scales than placebo group ( P postoperative scar pain and pruritus VAS scores between the groups ( P > 0.05 ) . Conclusions Application of silicone gel had no beneficial effects on scar pain and itching relief during the early postoperative period of TKA.Level of evidence I-R and omized Controlled",
"Core outcome sets are becoming a burgeoning area of clinical epidemiology research . There are varying definitions and terminologies used , but the agreed elements of a core outcome set are captured in the following definition : an agreed st and ardized set of outcome domains with at least one instrument in each domain that should be measured and reported , as a minimum , for use in primary r and omized/ observational studies and systematic review s , addressing effectiveness questions in health or health care . The OMERACT ( Outcome Measures in Rheumatology ) group has been developing these since 1992 [ 1 ] ; interest has recently increased with the attention given to selective reporting by groups such as CONSORT , PRISMA , Clinical Trials.gov [ 2 ] , the alltrials initiative ( http://www . alltrials.net/ ) , plus the need for agreement on a parsimonious list of patient important outcomes for systematic review s and guidelines championed by the Cochrane Collaboration . The Cochrane Collaboration Systematic Review s now have moved the key table of results [ the Summary of Findings table ( http://h and book.cochrane.org/ ) ] from the back of the review to the front pagedthis permits only up to seven patient-important outcomes that should include both benefits and harms . Systematic review s of interventions by different groups within the Cochrane Collaboration ( declaration of interest : PT coleads one of these groupsdthe Cochrane Musculoskeletal Review Group ) for the same condition , such as fibromyalgia or osteoarthritis , currently present a wide range of different outcomes in these summary of findings tables that patient , clinician , policymaker , and reader have indicated are just too confusing . In contrast , this has been addressed successfully in rheumatoid arthritis where the OMERACT core outcome set or a derivative has been adopted by international agencies with a result ing increase in their adoption in the primary studies [ 3,4 ] . The GRADE recommendations likewise have formalized a process , whereby they identify the critical patient-important outcomes . The Core Outcome Measures in Effectiveness Trials ( COMET ) [ 5 ] initiative [ http://www.comet-initiative.org/ ] has taken this to the next level providing a home for discourse between over 100 groups around the world across all subject areas ; meetings have been held in Europe and North America for information exchange between core set developers across different disciplines . Annual COMET meetings are held that provide an important forum for clinical epidemiologists to meet core set development research ers from other disciplines and with the other",
"In this prospect i ve multicenter study we included subjects younger than 60 years of age and scheduled for primary total knee arthroplasty ( TKA ) . The study assessed patients ' overall satisfaction , fulfillment of preoperative expectations , the effect on socioeconomic parameters , and quality of sexual life . Question naires including Oxford Knee Score ( OKS ) and SF-36 were evaluated preoperatively and 3 , 6 , and 12 months postoperatively . OKS and SF-36 showed significant improvements . However , patient satisfaction and fulfillment of personal expectations did not reflect these scores . Overall , TKA did not affect the patients ' socioeconomic status , and overall , patients did not experience impairment of sexual life , but decreased frequency and negative affection of sexual practice should be anticipated . Alternative outcome measurements of TKA surgery not focusing on implants and surgical techniques shed new light on important consequences of arthroplasty surgery",
"Certain recreational , cultural , occupational , and religious practice s may require knee flexion exceeding typical daily living activity needs . Some total knee prostheses mechanically accommo date high flexion to help meet such dem and s , e.g. , the Vanguard knee ( Biomet , Inc. , Warsaw , IN ) which can mechanically achieve 140 ° -145 ° . This multicenter , prospect i ve clinical study of 957 Vanguard knees ( 865 patients ) examined mid-term outcomes . The Kaplan-Meier survivorship estimate was 97.8 % ( 95 % CI : 96.5 - 98.7 % ) at 7.0 years . For patients with ≥ 2-year follow-up ( n=627 ) , mean peak flexion increased from 116.8 ° to 124.8 ° ( P 105 ° , the mean increases were 27.8 ° , 22.0 ° , and 3.6 ° , respectively . Mean Knee Society Knee and Function scores increased from 45.9 and 45.5 points to 92.0 and 73.8 points , respectively ( P<0.001 )",
"BACKGROUND The superiority of mobile-bearing total knee arthroplasty implants over fixed-bearing implants , or vice versa , is still debated . METHODS A series of patients with similar clinical and radiographic characteristics were treated consecutively with 100 fixed-bearing followed by 100 rotating-platform implants . Patients underwent prospect i ve clinical and radiographic evaluation . RESULTS The mean duration of follow-up was 116 months ( range , sixty-one to 144 months ) . Clinical , radiographic , and implant survival outcomes were compared . No significant differences between the mobile-bearing and fixed-bearing groups were found with respect to the clinical outcome or cumulative implant survival at the time of the latest follow-up . Three of the fixed-bearing implants and one of the rotating-platform implants had required revision surgery . CONCLUSIONS No differences between mobile-bearing and fixed-bearing design s were demonstrated at a mean of 116 months of follow-up",
"BACKGROUND We present a prospect i ve , r and omised , multi-surgeon , controlled trial comparing minimally invasive ( MIS ) and st and ard approach total knee arthroplasty ( TKA ) . METHODS Participants underwent unilateral TKA . Patients were r and omised to Bristol , quadriceps sparing MIS or st and ard medial parapatellar approaches . Length of stay with secondary outcome measures including knee range of movement , Oxford Knee Score ( OKS ) , Western Ontario and McMaster Universities Arthritis Index ( WOMAC ) and American Knee Society Score ( KSS ) up to 2 years . Radiographic and post operative assessment was blinded . RESULTS 86 patients ( 92 knees ) participated in the study . Mean operative time between MIS and control groups was 95.5 ( 95 % CI 90.0 - 101.0 ) and 94.8 ( 95 % CI 88.2 - 101.4 ) minutes respectively . Mean readiness for discharge was shorter in the MIS group 4.5±1.5 ( 95 % CI , 4.1 - 4.9 ) days versus 5.9±2.7 ( 95 % CI , 5.1 - 6.7 ) days amongst controls ( p=0.004 ) . Patients in the MIS group had fewer complications ( p=0.003 ) . One patient developed a deep vein thrombosis ( DVT ) and one required revision surgery , both in the control group . 83 patients completed follow up to 2 years ( 40 MIS , 43 controls ) . Range of movement and other outcome measures improved up to 1 year post-operatively with no statistically significant differences between MIS and controls . We found no evidence of radiographic loosening in either group at the 2 year follow up . CONCLUSIONS MIS offers reduced length of stay and fewer complications for patients following TKR without evidence of component mal-alignment . Our findings of fewer systemic complications in MIS TKR patients warrant further future study . LEVEL OF EVIDENCE Level 1",
"Satisfaction with care is important to both patients and to those who pay for it . The Net Promoter Score ( NPS ) , widely used in the service industries , has been introduced into the NHS as the ' friends and family test ' ; an overarching measure of patient satisfaction . It assesses the likelihood of the patient recommending the healthcare received to another , and is seen as a discriminator of healthcare performance . We prospect ively assessed 6186 individuals undergoing primary lower limb joint replacement at a single university hospital to determine the Net Promoter Score for joint replacements and to evaluate which factors contributed to the response . Achieving pain relief ( odds ratio ( OR ) 2.13 , confidence interval ( CI ) 1.83 to 2.49 ) , the meeting of pre-operative expectation ( OR 2.57 , CI 2.24 to 2.97 ) , and the hospital experience ( OR 2.33 , CI 2.03 to 2.68 ) are the domains that explain whether a patient would recommend joint replacement services . These three factors , combined with the type of surgery undertaken ( OR 2.31 , CI 1.68 to 3.17 ) , drove a predictive model that was able to explain 95 % of the variation in the patient 's recommendation response . Though intuitively similar , this ' recommendation ' metric was found to be material ly different to satisfaction responses . The difference between THR ( NPS 71 ) and TKR ( NPS 49 ) suggests that no overarching score for a department should be used without an adjustment for case mix . However , the Net Promoter Score does measure a further important dimension to our existing metrics : the patient experience of healthcare delivery",
"We r and omized 126 consecutive patients undergoing primary total knee arthroplasty into group 1 : patella denervation ( n = 63 ) and group 2 : no patella denervation ( n = 63 ) . Assessment was performed preoperatively and at 3 , 12 and 24 months post-operatively . Average follow-up of patients was 26.5 months for denervation group and 26.3 months for no denervation group ( P = 0.84 ) . Pain scores for anterior knee pain were significantly better in the denervation group at 3 months but not at 12 and 24 months . Patient satisfaction was higher in the denervation group . Flexion range was higher in the denervation group at 3 , 12 and 24 months review ( P < 0.01 ) . There were , however , no statistically significant differences with other vali date d knee scores",
"We investigated whether a postulated biomechanical advantage conferred to the extensor mechanism by a change in knee implant design was detectable in patients by direct physical testing . 212 TKA patients were enrolled in a double blind r and omized controlled trial to receive either a traditional implant or one which incorporated new design features . Extensor mechanism power output and physical performance on a battery of timed functional activities was assessed pre-operatively and then at 6 , 26 , and 52 weeks post-operatively . Significantly enhanced power output was observed in both groups post-arthroplasty ; however , the new design implant group demonstrated a greater change in power output than the traditional implant group . Posthoc testing of between group differences highlighted greater improvement at all post-operative assessment s. At 52 weeks , patients receiving the implant with the postulated biomechanical advantage achieved 116 % of the power output of their contralateral limb , whereas patients with the traditional design achieved 90 % . No between group difference was detected in the patient 's time to complete functional tasks . Thus , patients receiving a knee implant of a modern design ( theoretically able to confer a mechanical advantage to the extensor mechanism ) were found to generate significantly greater extensor power than those receiving a traditional implant without the postulated mechanical advantage",
"Purpose Patient-based and psychological factors do influence outcome in patients undergoing total knee arthroplasty ( TKA ) . The purpose was to investigate if preoperative psychological factors influence the subjective and objective outcomes 6 weeks , 4 months and 1 year after TKA . Our hypothesis was that there is a significant influence of psychological factors on clinical outcome scores before and after TKA . Methods A prospect i ve , longitudinal , single-cohort study investigating the correlation of depression , control beliefs , anxiety and a variety of other psychological factors with outcomes of patients undergoing TKA was performed . A total of 104 consecutive patients were investigated preoperatively using the Beck`s depression inventory , the State-Trait Anxiety Index , the question naire for assessment of control beliefs and the SCL-90R inventory . The Knee Society Clinical Rating System ( KSS ) and the WOMAC were used . Analysis of TKA position was performed on radiographs according to Ewald et al. Correlation of psychological variables with outcomes was performed ( p Self-efficacy did not influence clinical scores . More depressed patients showed higher pre- and postoperative WOMAC scores , but no difference in amelioration . KSS scores were not influenced . Patients with higher State and Trait Anxiety Indexes had higher WOMAC and lower KSS scores before and after the operation , but most significant correlations were SCL-90 dimensions had significant correlations with pre- and postoperative clinical scores , but not with their amelioration . The SCL-90 subscore for somatization and the overall SCL-90 significantly correlated with the WOMAC , KSS before and after TKA . Conclusions Depression , anxiety , a tendency to somatize and psychological distress were identified as significant predictors for poorer clinical outcomes before and /or after TKA . St and ardized preoperative screening and subsequent treatment should become part of the preoperative work-up in orthopaedic practice .Level of evidence Prognostic prospect i ve , Level",
"The superiority between posterior-stabilized mobile-bearing and fixed-bearing design s still remains controversial . Fifty-six consecutive patients undergoing primary , unilateral knee arthroplasty for osteoarthritis were r and omly assigned to receive either a mobile-bearing ( 29 patients ) or fixed-bearing ( 27 patients ) prosthesis . We report the results at 4 to 6.5 years ( mean , 5.5 ) follow-up . The Knee Society knee scores , pain scores , functional scores and Oxford knee scores were not statistically different ( P > 0.05 ) between the two groups . Mean postoperative range-of-motion of mobile-bearing knees was significantly greater than that of fixed-bearing knees ( 127º versus 111º , P = 0.011 ) . 72 % of patients could sit cross legged , 48 % could sit on the floor , and 17 % could squat . Kaplan-Meier survival rate was 100 % . No spin-out of mobile bearing was observed . The radiological analysis showed no osteolysis or implant loosening ",
"BACKGROUND CONTEXT It is well accepted that total hip and knee arthroplasty ( THA/TKA ) for osteoarthritis ( OA ) is associated with reliable and sustained improvements in postoperative health-related quality of life ( HRQoL ) . Although several studies have demonstrated comparable outcomes with THA/TKA after surgical intervention for lumbar spinal stenosis ( LSS ) , the sustainability of the outcome after LSS surgery compared with THA/TKA remains uncertain . PURPOSE The primary purpose of this study is to assess whether improvements in HRQoL after surgical management of focal lumbar spinal stenosis ( FLSS ) with or without spondylolisthesis are sustainable over the long term compared with that of THA/TKA for OA . STUDY DESIGN Single-center , retrospective , longitudinal matched cohort study of prospect ively collected outcomes , with a minimum of 5-year follow-up ( FU ) . PATIENT SAMPLE Patients who had primary one- to two-level spinal decompression with or without instrumented fusion for FLSS and THA/TKA for primary OA . OUTCOME MEASURES Postoperative change from baseline to last FU in Short-Form 36 physical component summary ( PCS ) and mental component summary ( MCS ) scores among groups was used as the primary outcome measure . METHODS An age , sex-matched inception cohort of primary one- to two-level spinal decompression with or without instrumented fusion for FLSS ( n=99 ) was compared with a cohort of primary THA ( n=99 ) and TKA ( n=99 ) for OA and followed for a minimum of 5 years . Linear regression was used for the primary analysis . RESULTS Mean ( percent ) FUs in months were 80.5 + 16.04 ( 79 % ) , 94.6 + 16.62 ( 92 % ) , and 80.6 + 16.84 ( 85 % ) for the FLSS , THA , and TKA cohorts , respectively , with a range of 5 to 10 years for all three cohorts . The number of patients who have undergone revision including those lost to FU for the FLSS , THA , and TKA cohorts were n=20 ( 20.2 % , same site [ n=7 ] and adjacent segment [ n=13 ] ) requiring 27 operations , n=3 ( 3 % , same site ) requiring 5 operations , and n=8 ( 8.1 % , same site ) requiring 12 operations , respectively ( p average time to first revision was 56/65/43 months , respectively . Mean postoperative PCS ( p MCS ( p scores improved significantly and were durable for all groups at the last FU . The mean changes from baseline PCS/MCS scores to last FU were 8.5/6.4 , 12.3/7.0 , and 8.3/4.9 for FLSS , THA , and TKA , respectively . Adjusting for baseline age , sex , body mass index , PCS score , and MCS score , there was a strong trend in favor of greater sustained change in the PCS score of THA over FLSS ( p=.07 ) and TKA ( p=.08 ) . No difference was noted for change in PCS score between FLSS and TKA ( p=.95 ) . No differences were noted for change in MCS score among all three cohorts ( p>.1 ) . CONCLUSIONS Significant improvements in HRQoL after surgical treatment of FLSS with or without spondylolisthesis and hip and knee OA are sustained for a mean of 7 to 8 years , with a minimum of 5-year FU . Despite a higher revision rate , patients undergoing surgery for FLSS can expect a comparable long-term average improvement in HRQoL from baseline compared with their peers undergoing TKA and to a lesser extent THA",
"Background As life expectancy of patients increases , more elderly patients are undergoing primary total hip arthroplasty ( THA ) and total knee arthroplasty ( TKA ) . There is a general perception of increased risk of complications in elderly patients . Our objective was to analyse the incidence of in-hospital medical and surgical complications following THA and TKA in octogenarian and nonagenarians . Material s and methods This was a prospect i ve review of 202 consecutive patients aged more than 80 years who underwent total hip and total knee arthroplasty ( 101 THA , 101 TKA ) over an 18-month period . In this single-centre observational study , collected data included patient demographics , American Society of Anethesiologists ( ASA ) grade , length of hospital stay and peri-operative medical and surgical complications during their hospital stay . Results Median age of patients was 83 years . Median ASA grade was 3 . Mean length of hospital stay was 7.5 days . There were 14 major systemic complications in the THA group and 13 in the TKA group . While 1 major local complication occurred in each group , there were 6 minor local complications in THA and 7 in the TKA group . All the complications occurred within 5 post-operative days . There was no in-hospital mortality . Conclusion In our study , we found that the incidence of peri-operative medical and surgical complications is higher in those over 80 years , compared to the published literature in patients of all age groups undergoing THA and TKA . Awareness of a higher incidence of major systemic complications should alert the treating surgeon to carry out comprehensive peri-operative management in this subset of patients , which could lead to better outcomes",
"Abstract Purpose Type II valgus knees are defined by medial collateral ligament laxity . This paper studies the results of posterior stabilized ( PS ) and cruciate retaining ( CR ) knee implants in type II valgus knees . Methods From 1999 to 2009 , there were 100 type II valgus knees in 95 patients eligible for study ( 63 PS , 37 CR ) . Patients had prospect ively collected clinical data up to 2 years after surgery . Results At 24 months after surgery , the CR group had reduced range of motion ( PS : median 126.0 ° , CR : median 114 ° ; n.s . ) and a marginally but statistically significant increased valgus alignment ( PS : median 5 ° , CR : median 6 ° ; p = 0.011 ) . Despite this , both groups produced equal and marked improvements in SF-36 , function score and knee score of the Knee Society score , and Oxford knee score . Conclusions Overall , both PS and CR implants performed equally well in type II valgus knees at 24 months post-operatively . Further longer-term studies would be warranted to assess for late instability . Level of evidence Retrospective , Level III",
"We assessed the effect of mental disability on the outcome of total knee replacement ( TKR ) and investigated whether mental health improves post-operatively . Outcome data were prospect ively recorded over a three-year period for 962 patients undergoing primary TKR for osteoarthritis . Pre-operative and one year Short-Form (SF)-12 scores and Oxford knee scores ( OKS ) were obtained . The mental component of the SF-12 was stratified into four groups according to level of mental disability ( none ≥ 50 , mild 40 to 49 , moderate 30 to 39 , severe mental disability had a significantly greater subjective physical disability according to the SF-12 ( p = 0.06 ) and OKS ( p The improvement in the disease-specific score ( OKS ) was not affected by a patient 's mental health ( p = 0.33 ) . In contrast , patients with mental disability had less of an improvement in their global physical health ( SF-12 ) ( p 0.001 ) . However , patients with any degree of mental disability had a significant improvement in their mental health post-operatively ( p 0.001 ) . Despite a similar improvement in their disease-specific scores and improvement in their mental health , patients with mental disability were significantly more likely to be dissatisfied with their TKR at one year ( p = 0.001 ) . Patients with poor mental health do benefit from improvements in their mental health and knee function after TKR , but also have a higher rate of dissatisfaction",
"Background Surgical treatment of osteoarthritis with total knee arthroplasty ( TKA ) usually takes place in a complete bloodless field using a tourniquet . However , doing the surgery without a tourniquet may reduce muscle damage , post-surgery pain and led to improved functional rehabilitation and mobilization . Methods / Design A prospect i ve , blinded , parallel-group , controlled superiority trial , with balanced r and omization [ 1:1 ] . Patients aged 50 or older eligible for primary TKA for osteoarthritis will be consecutively recruited from Department of Orthopedic Surgery and Traumatology , Odense University Hospital , Denmark . A total of 80 patients will be r and omly allocated to TKA with or without tourniquet application providing 40 patients for each of the two treatment arms . The tourniquet assisted TKA group will have an automatic , micro-processor-based pneumatic tourniquet inflated around the thigh during surgery . The non-tourniquet assisted TKA group will have surgery performed without application of a tourniquet . The primary aim is to compare tourniquet assisted to non-tourniquet assisted TKA on patient-reported physical function ( KOOS-ADL ) . The secondary aim is to compare post-surgery pain , function in sports and recreation , quality of life , and performance-based physical function . The explorative outcomes include ; use of pain medication , single-fiber muscle damage , and changes in mechanical muscle function . The primary endpoint will be at 3-months following surgical treatment , and the time-point for analysis of the primary outcome . However , follow-up will continue up to 1 year , and provide medium-term results . The treatment effect ( difference in KOOS-ADL ) will be analyzed using a r and om effects regression model , crude and adjusted results will be reported , if needed . Analyses will be based on the intention-to-treat ( ITT ) . Subsequent per- protocol analysis may be necessary in the event of a substantial number of patients ( > 15 % ) being lost during follow-up . The number needed to treat ( NNT ) for a positive effect of treatment ( > 10 points on KOOS-ADL ) will be reported . Discussion This is the first r and omized clinical trial comparing the efficacy of tourniquet assisted TKA on patient-reported physical function supported by a range of performance-based secondary outcome measures . As such it will provide high quality evidence that may help determine whether tourniquet should be used in future TKA procedures in patients with osteoarthritis of the knee . Trial registration Clinical TrialsNCT01891266",
"Background and purpose — Tourniquet application is still a common practice in total knee arthroplasty ( TKA ) surgery despite being associated with several adverse effects . We evaluated the effects of tourniquet use on functional and clinical outcome and on knee range of motion ( ROM ) . Patients and methods — 70 patients who underwent TKA were r and omized into a tourniquet group ( n = 35 ) and a non-tourniquet group ( n = 35 ) . All operations were performed by the same surgeon and follow-up was for 1 year . Primary outcomes were functional and clinical outcomes , as evaluated by KOOS and knee ROM . Secondary outcomes were intraoperative blood loss , surgical time and visibility , postoperative pain , analgesic consumption , and transfusion requirements . Results — Patients in the non-tourniquet group showed a better outcome in all KOOS subscores and better early knee ROM from surgery to week 8 . No difference was detected at the 6- and 12-month follow-ups . Postoperative pain and analgesic consumption were less when a tourniquet was not used . Surgical time and visibility were similar between groups . Intraoperative blood loss was greater when not using a tourniquet , but no postoperative transfusions were required . Interpretation— This study shows that TKA without the use of a tourniquet results in faster recovery in terms of better functional outcome and improved knee ROM . Furthermore , reduced pain and analgesic use were registered and no intraoperative difficulties were encountered",
"Background To characterize whether medical comorbidities , depression and anxiety predict patient-reported functional improvement after total knee arthroplasty ( TKA ) . Methods We analyzed the prospect ively collected data from the Mayo Clinic Total Joint Registry for patients who underwent primary or revision TKA between 1993–2005 . Using multivariable-adjusted logistic regression analyses , we examined whether medical comorbidities , depression and anxiety were associated with patient-reported subjective improvement in knee function 2- or 5-years after primary or revision TKA . Odds ratios ( OR ) , along with 95 % confidence intervals ( CI ) and p-value are presented . Results We studied 7,139 primary TKAs at 2- and 4,234 at 5-years ; and , 1,533 revision TKAs at 2-years and 881 at 5-years . In multivariable-adjusted analyses , we found that depression was associated with significantly lower odds of 0.5 ( 95 % confidence interval [ CI ] : 0.3 to 0.9 ; p = 0.02 ) of ‘ much better ’ knee functional status ( relative to same or worse status ) 2 years after primary TKA . Higher Deyo-Charlson index was significantly associated with lower odds of 0.5 ( 95 % CI : 0.2 to 1.0 ; p = 0.05 ) of ‘ much better ’ knee functional status after revision TKA for every 5-point increase in score . Conclusions Depression in primary TKA and higher medical comorbidity in revision TKA cohorts were associated with suboptimal improvement in index knee function . It remains to be seen whether strategies focused at optimization of medical comorbidities and depression pre- and peri-operatively may help to improve TKA outcomes . Study limitations include non-response bias and the use of diagnostic codes , which may be associated with under-diagnosis of conditions",
"We investigated the proportion of orthopaedic procedures supported by evidence from r and omised controlled trials comparing operative procedures to a non-operative alternative . Orthopaedic procedures conducted in 2009 , 2010 and 2011 across three metropolitan teaching hospitals were identified , grouped and ranked according to frequency . Search es of the Cochrane Central Register of Controlled Trials ( CENTRAL ) , the Cochrane Data base of Systematic Review s ( CDSR ) and the Data base of Abstract s of Review s of Effects ( DARE ) were performed to identify RCTs evaluating the most commonly performed orthopaedic procedures . Included studies were categorised as “ supportive ” or “ not supportive ” of operative treatment . A risk of bias analysis was conducted for included studies using the Cochrane Collaboration 's Risk of Bias tool . A total of 9,392 orthopaedic procedures were performed across the index period . 94.6 % ( 8886 procedures ) of the total volume , representing the 32 most common operative procedure categories , were used for this analysis . Of the 83 included RCTs , 22.9 % ( 19/83 ) were classified as supportive of operative intervention . 36.9 % ( 3279/8886 ) of the total volume of procedures performed were supported by at least one RCT showing surgery to be superior to a non-operative alternative . 19.6 % ( 1743/8886 ) of the total volume of procedures performed were supported by at least one low risk of bias RCT showing surgery to be superior to a non-operative alternative . The level of RCT support for common orthopaedic procedures compares unfavourably with other fields of medicine",
"Summary Objective The aim of this study was to compare the responsiveness of various patient-reported outcome measures ( PROMs ) and clinician-reported outcomes following total knee arthroplasty ( TKA ) over a 2-year period . Methods Data were collected in a prospect i ve cohort study of primary TKA . Patients who had completed Forgotten Joint Score-12 ( FJS-12 ) , Western Ontario and McMaster Universities ( WOMAC ) osteoarthritis ( OA ) index , EQ-5D , Knee Society Score and range of movement ( ROM ) assessment were included . Five time points were assessed : pre-operative , 2 months , 6 months , 1 year and 2 years post-operative . Results Data from 98 TKAs were available for analysis . Largest effect sizes ( ES ) for change from pre-operative to 2-month follow-up were observed for the Knee Society Score ( KSS ) Knee score ( 1.70 ) and WOMAC Total ( −1.50 ) . For the period from 6 months to 1 year the largest ES for change were shown by the FJS-12 ( 0.99 ) and the KSS Function Score ( 0.88 ) . The EQ-5D showed the strongest ceiling effect at 1-year follow-up with 84.4 % of patients scoring the maximum score . ES for the time from 1- to 2-year follow-up were largest for the FJS-12 ( 0.50 ) . All other outcome measures showed ES equal or below 0.30 . Conclusion Outcome measures differ considerably in responsiveness , especially beyond one year post-operatively . Joint-specific outcome measures are more responsive than clinician-reported or generic health outcome tools . The FJS-12 was the most responsive of the tools assessed ; suggesting that joint awareness may be a more discerning measure of patient outcome than traditional PROMs",
"Background — Attempts to relate patellar cartilage involvement to anterior knee pain ( AKP ) have yielded conflicting results . We determined whether the condition of the cartilage of the patella at the time of knee replacement , as assessed by the OARSI score , correlates with postsurgical AKP . Patients and methods — We prospect ively studied 100 patients undergoing knee arthroplasty . At surgery , we photographed and biopsied the articular surface of the patella , leaving the patella unresurfaced . Following determination of the microscopic grade of the patellar cartilage lesion and the stage by analyzing the intraoperative photographs , we calculated the OARSI score . We interviewed the patients 1 year after knee arthroplasty using the HSS patella score for diagnosis of AKP . Results — 57 of 95 patients examined had AKP . The average OARSI score of painless patients was 13 ( 6–20 ) and that of patients with AKP was 15 ( 6–20 ) ( p = 0.04 ) . Patients with OARSI scores of 13–24 had 50 % higher risk of AKP ( prevalence ratio = 1.5 , 95 % CI : 1.0–2.3 ) than patients with OARSI scores of 0–12 . Interpretation — The depth and extent of the cartilage lesion of the knee-cap should be considered when deciding between the various options for treatment of the patella during knee replacement",
"OBJECTIVE The aim of this study was to develop and vali date a user friendly performance based knee outcome score for use in active patients undergoing TKA surgery . DESIGN We prospect ively studied a cohort of 50 subjects without any knee symptoms , and 50 patients who underwent TKA for osteoarthritis ( OA ) . The patients were assessed pre- and postoperatively . SF-36 and WOMAC were concurrently administered for comparison . Patients completed seven physical tasks of the finalised outcome instrument which were objective ly assessed and scored . RESULTS The mean functional score was 31.7 in the normal subjects . The mean functional score improved postoperatively from 10.0 to 17.7 ( P TKA group . Our results confirm that the performance based score has a high test-retest reliability ( intra-class correlation coefficient ( ICC ) of 0.89 ) , internal consistency ( Cronbach 's alpha 0.84 ) and construct validity showing expected correlations with relevant components of the WOMAC and SF-36 scores . The responsiveness as measured by the effect size compared favourably with the same relevant components of the SF-36 and WOMAC . CONCLUSIONS Our performance based knee function score is a reliable dimension specific tool to detect change in musculoskeletal function after TKA . It complements existing self-reported outcome tools in facilitating a comprehensive assessment of patients following TKA",
"Purpose Preoperative range of motion ( ROM ) is the most important variable to determine final flexion after total knee arthroplasty ( TKA ) . The purpose of this study was to determine whether a preoperative home exercise program could improve ROM in the arthritic knee and whether this influenced ROM and functional recovery following primary TKA . Methods During the period between 2005 and 2006 , one hundred and twenty-two patients with gonarthrosis were included in a prospect i ve study and r and omly allocated to either the control or the treatment group . The sixty-one subjects in the treatment group underwent a 6-week home-based exercise program before TKA surgery . All one hundred and twenty-two patients were assessed before and after this exercise intervention . Postoperative assessment s were at 6 weeks , 6 months and 1 year . Each evaluation included knee ROM and the Knee Society Clinical Rating System . Length of hospital stay and postoperative duration before achieving 90 ° of knee flexion were also recorded . Results Exercise program improves knee motion in the presence of gonarthrosis . After TKA , the patients in the exercise group achieved 90 ° of knee flexion faster and had a shorter hospital stay . There is no prolonged effect on knee motion or patient function between 6 weeks and 1 year postoperatively . Conclusion Preoperative exercise of the arthritic knee facilitates immediate postoperative recovery following primary TKA.Levels of evidence Therapeutic study , Level",
"Purpose The posterior condylar offset ( PCO ) and the tibiofemoral contact point ( CP ) have been reported as important factors that can influence range of motion and clinical outcome after total knee arthroplasty . A mobile-bearing knee implant with an anterior posterior gliding insert would in theory be more sensitive for changes in PCO and CP . For this reason , we analysed the PCO and CP and the relation with outcome and range of motion in 132 patients from a prospect ively documented cohort in this type of implant . Methods The prosthesis used was a posterior cruciate retaining AP gliding mobile-bearing total knee replacement ( SAL II Sulzer Medica , Switzerl and ) . In 132 knees , the pre- and postoperative PCO and postoperative CP were evaluated . Measurements were made on X-rays of the knee taken in approximately 90 ° of flexion and with less than 3-mm rotation of the femur condyles . The outcome parameters , range of motion ( ROM ) and the knee society score ( KSS ) , for each knee were determined preoperatively and at 5-year follow-up . Results The mean KSS improved from 91 to 161 at 5-year follow-up ( p the mean ROM from 102 to 108 ( p The mean PCO difference ( postoperative PCO – preoperative PCO ) was—0.05 mm ( SD 2.15 ) . The CP was on average 53.9 % ( SD 5.5 % ) . ROM was different between the 3 PCO groups ( p = 0.05 ) : patients with 3 or more mm decrease in PCO had the best postoperative ROM ( p = 0.047 ) . There was no statistical difference between the postoperative ROM between patients with a stable PCO and those with an increased PCO . There was no correlation between the difference in PCO and the difference in ROM ; RPearson = −0.056 . There was no difference in postoperative ROM or postoperative total KSS between CP 60 % : p = 0.22 , p = 0.99 , for ROM and KSS , respectively . Scatter plots showed uniform clouds of values : increase or decrease in PCO and CP had no significant influence on ROM or KSS . Conclusion The hypotheses that a stable PCO and a more natural CP increase postoperative ROM and improve clinical outcome could not be confirmed . On the contrary , a decreased PCO seemed to improve knee flexion . Furthermore , a relationship between PCO and CP could not be found . Level of evidence Prospect i ve cohort study , Level II",
"Purpose Mobile-bearing knee replacements were introduced as an alternative to their fixed-bearing counterparts . Movement of the polyethylene insert relative to the tibial tray has been shown to decrease contact stresses , wear and polyethylene-induced osteolysis . The aim of this study is to compare outcomes between mobile and fixed-bearing surfaces of the Rotaglide+ total knee prosthesis . Methods A prospect i ve , partially r and omised twin cohort study of 149 Rotaglide+ total knee arthroplasties performed in one unit between September 2000 and January 2005 , was carried out . The patients were allocated to a mobile or fixed bearing . The patients were assessed using a pain visual analogue score ( VAS ) , the American Knee Surgeons Score ( AKSS ) the range of movement , the Oxford Knee Score ( OKS ) and walking time . Seventy-five patients had mobile-bearing surfaces , and 74 had fixed bearings . Results At 5-year follow – up , there was no significant difference between the fixed- and mobile-bearing implants with respect to range of movement [ 104.7(SD 17.0 ) vs. 103.6(SD 15.7 ) degrees ] ; AKSS [ 146.6(SD 23.9 ) vs. 144.1(SD 32.4 ) ] ; VAS [ 3.3(SD 1.2 ) vs. 3.4(SD 1.3 ) ] ; OKS [ 30.8(SD 9.7 ) vs. 29.6(SD 10.9 ) ] , respectively . Conclusion This study is the first of its kind to outline the medium-term ( ≥5 years ) outcomes in Rotaglide+ total knee replacements . Its findings reinforce previous research which has shown no discernible difference in clinical outcomes between the 2 groups . Level of evidence II",
"We have previously reported the short-term radiological results of a r and omised controlled trial comparing kinematically aligned total knee replacement ( TKR ) and mechanically aligned TKR , along with early pain and function scores . In this study we report the two-year clinical results from this trial . A total of 88 patients ( 88 knees ) were r and omly allocated to undergo either kinematically aligned TKR using patient-specific guides , or mechanically aligned TKR using conventional instruments . They were analysed on an intention-to-treat basis . The patients and the clinical evaluator were blinded to the method of alignment . At a minimum of two years , all outcomes were better for the kinematically aligned group , as determined by the mean Oxford knee score ( 40 ( 15 to 48 ) versus 33 ( 13 to 48 ) ; p = 0.005 ) , the mean Western Ontario McMaster Universities Arthritis index ( WOMAC ) ( 15 ( 0 to 63 ) versus 26 ( 0 to 73 ) ; p = 0.005 ) , mean combined Knee Society score ( 160 ( 93 to 200 ) versus 137 ( 64 to 200 ) ; p= 0.005 ) and mean flexion of 121 ° ( 100 to 150 ) versus 113 ° ( 80 to 130 ) ( p = 0.002 ) . The odds ratio of having a pain-free knee at two years with the kinematically aligned technique ( Oxford and WOMAC pain scores ) was 3.2 ( p = 0.020 ) and 4.9 ( p = 0.001 ) , respectively , compared with the mechanically aligned technique . Patients in the kinematically aligned group walked a mean of 50 feet further in hospital prior to discharge compared with the mechanically aligned group ( p = 0.044 ) . In this study , the use of a kinematic alignment technique performed with patient-specific guides provided better pain relief and restored better function and range of movement than the mechanical alignment technique performed with conventional instruments",
"Purpose The purpose of this prospect i ve , r and omised study was to evaluate long-term clinical results , radiographic findings , complications and revision and survivorship rates in patients simultaneous , cemented and cementless total knee arthroplasties ( TKAs ) in the same patients . Methods Bilateral , sequential , simultaneous TKAs were performed in 80 patients ( 160 knees ) . There were 63 women and 17 men with a mean age of 54.3 years ( range 49–55 ) , who received a cementless prosthesis in one knee and a cemented prosthesis in the other . The mean follow-up was 16.6 years ( range 16–17 ) . Results At final review , the mean Knee Society ( KS ) knee scores ( 95.8 versus 96.9 ) , Western Ontario and McMaster Universities ( WOMAC ) osteoarthritis ( OA ) index ( 25.4 versus 25.9 ) , range of motion ( ROM ) ( 125 ° versus 128 ° ) , patient satisfaction ( 8.1 versus 8.3 ) and radiological results were similar in both groups . Femoral component survival rate was 100 % in both groups at 17 years ; at 17 years , the cemented tibial component survival rate was 100 % and the cementless tibial component 98.7 % . No osteolysis was identified in either group . Conclusion Long-term results of both cementless and cemented TKAs were encouraging in patients with OA who were However , we found no evidence to prove the superiority of cementless over cemented TKAs",
"Total knee arthroplasty ( TKA ) is a cost-effective procedure used to treat degenerative knee disease with excellent long-term outcomes . However , TKA has not always result ed in excellent functional and patient satisfaction outcomes , partly due to the use of prostheses that did not reproduce natural knee kinematics . Due to a paucity of reports on single-radius design s , the authors evaluated the clinical and patient-reported outcomes of primary TKA in patients who had received a single-radius prosthesis . A total of 287 TKAs from 7 centers were prospect ively evaluated . Mean follow-up was 5 years , with each patient undergoing year re-evaluation . Kaplan-Meier implant survivorship was 99.7 % at a final follow-up of 7 years . The total reoperation rate was 1.4 % . Clinical outcomes demonstrated significant improvements in Knee Society , Short Form 36 , and activity scores at a mean follow-up of 5 years . The authors believe that various features of this prosthesis may have contributed to these excellent outcomes . Further longer-term studies are necessary to better evaluate these outcomes",
"The aim of this study was to explore the application value of the lower limbs robot-assisted training system for post-total knee replacement ( TKR ) gait rehabilitation . A total of 60 patients with osteoarthritis of the knee were equally r and omized into the traditional and robot-assisted rehabilitation training groups within 1 week after TKR . All patients received 2-week training . Scores of hospital for special surgery ( HSS ) , knee kinesthesia grade s , knee proprioception grade s , functional ambulation ( FAC ) scores , Berg balance scores , 10-m sitting – st and ing time , and 6-min walking distances were compared between the groups . The HSS score , Berg score , 10-m sitting – st and ing time , and 6-min walking distance of the robot-assisted training group were significantly higher than the control group ( P Its knee kinesthesia grade , knee proprioception grade , and FAC score were better than the control group but not significantly ( P > 0.05 ) . Lower limbs robot-assisted rehabilitation training improves post-TKR patients ’ knee proprioception and stability more effectively compared with the traditional method . It improves patients ’ gait and symptoms , increases their walking speed , and prolongs their walking distances , which benefit their return to family and society",
"Lower extremity osteoarthritis with concomitant low-back pain ( LBP ) may obscure a clinician 's ability to properly evaluate the status of hip or knee osteoarthritis and subsequent total joint arthroplasty ( TJA ) c and idacy . A prospect i ve cohort study was conducted to determine prevalence and severity of preoperative LBP among TJA patients , and the effect of TJA on alleviating LBP . Preoperative moderate to worst imaginable LBP pain on the Oswestry Disability Index ( ODI ) was significantly higher among hips compared to knees ( 28.8 % vs. 16.1 % , P ODI improvement from preoperative to one-year postoperative . TJA c and i date s with considerable preoperative LBP should be counselled that TJA outcome may be impaired by the coexistence of spine disease , and that residual spine pain may continue following otherwise successful TJA",
"OBJECTIVE To study the association between weight gain and the risk of knee replacement ( KR ) due to primary osteoarthritis ( OA ) , and to evaluate whether the association differs by age . DESIGN 225,908 individuals from national health screenings with repeated measurements of height and weight were followed prospect ively with respect to KR identified by linkage to the Norwegian Arthroplasty Register . Cox proportional hazard regression was used to calculate sex-specific relative risks ( RR ) of KR according to change in Body Mass Index ( BMI ) and weight , corresponding analyses were done for age categories at first screening . RESULTS During 12 years of follow up , 1591 participants received a KR due to primary OA . Men in the highest quarter of yearly change in BMI had a RR of 1.5 ( 95 % confidence interval ( CI ) 1.1 - 1.9 ) of having a KR compared to those in the lowest quarter . For women the corresponding RR was 2.4 ( 95 % CI 2.1 - 2.7 ) . Men under the age of 20 at the first screening had a 26 % increased risk for KR per 5 kg weight gain , for women the corresponding increase was 43 % . At older age the association became weaker , and in the oldest it was lost . CONCLUSIONS Weight gain increases the risk for later KR both in men and women . The impact of weight gain is strongest in the young , at older age the association is weak or absent . Our study suggests that future OA may be prevented by weight control and that preventive measures should start at an early age",
"BACKGROUND Patellar mobilization technique during total knee arthroplasty has been debated , with some suggesting that lateral retraction , rather than eversion , of the patella may be beneficial . We hypothesized that patients with knees surgically exposed using patellar lateral retraction would have comparable outcomes with patients with knees surgically exposed using patellar eversion . METHODS After an a priori power analysis , 120 patients with degenerative arthrosis were prospect ively enrolled and were r and omized to one of two patellar exposure techniques during the primary total knee arthroplasty : lateral retraction or eversion . The primary outcome measure was one-year , dynamometer-measured quadriceps strength . The secondary outcome measures evaluated during hospital stay included the ability to straight-leg raise , visual analog scale in pain , walking distance , and length of stay . The secondary outcome measures that were evaluated preoperatively and through a one-year follow-up included the Short Form-36 Physical Component Summary and Mental Component Summary scores , range of motion , quadriceps strength , and radiographic rate of patella baja and tilt . RESULTS A mixed-model analysis of variance showed no significant differences between the two groups in the one-year outcome measures . At one year postoperatively , quadriceps strength was not different between groups ( p = 0.77 ) , and the range of motion significantly improved ( p groups . The Short Form-36 Physical Component Summary score and Mental Component Summary score significantly improved ( p the Physical Component Summary score and p = 0.71 for the Mental Component Summary score ) , and the scores were not different at one year after surgery . There were no significant differences between groups in the change in frequency of the radiographic patella baja ( p = 0.99 ) or the radiographic patellar tilt ( p = 0.77 ) from before surgery to one year after surgery . CONCLUSIONS Lateral retraction of the patella did not lead to superior postoperative results compared with eversion of the patella during total knee arthroplasty as evaluated using our primary outcome measure of one-year , dynamometer-measured quadriceps strength or our secondary outcome measures . LEVEL OF- EVIDENCE Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence",
"OBJECTIVE To provide new data on minimally clinical important difference ( MCID ) and percentages of responders on pain and functional dimensions of Western Ontario and McMaster Osteoarthritis Index ( WOMAC ) in patients who have undergone total knee replacement ( TKR ) . METHODS 1-year prospect i ve multicentre study with two different cohorts . Consecutive patients on the waiting list were recruited . There were 415 and 497 patients included . Pain and function were collected by the reverse scoring option of the WOMAC ( 0 - 100 , worst to best ) . Transition items ( five point scale ) were collected at 1-year and MCID was calculated through mean change in patients somewhat better , Receiver Operating Characteristic ( ROC ) and two other questions about satisfaction . Analysis was performed in the whole sample and by tertiles of baseline severity . Likewise were calculated the percentages of patients who attained cut-off values . RESULTS Global MCID for pain were about 30 in both cohorts and 32 for . By ROC these values were about 20 and 24 respectively . According to the other two transitional questions these values were for pain 27 and 20 for function . By tertiles the worst the baseline score the higher the cut-off values . Percentage of responders does not change when comparing responders to the global MCID with their own tertile MCID and were about 61 % for pain and 50 % for function . CONCLUSION Due to the wide variations , MCID estimates should be calculated and used according to the baseline severity score",
"Objective . To define pain and physical function cutpoints that would , coupled with structural severity , define a surrogate measure of “ need for joint replacement surgery , ” for use as an outcome measure for potential structure-modifying interventions for osteoarthritis ( OA ) . Methods . New scores were developed for pain and physical function in knee and hip OA . A cross-sectional international study in 1909 patients was conducted to define data -driven cutpoints corresponding to the orthopedic surgeons ’ indication for joint replacement . A post hoc analysis of 8 r and omized clinical trials ( 1379 patients ) evaluated the prevalence and validity of cutpoints , among patients with symptomatic hip/knee OA . Results . In the international cross-sectional study , there was substantial overlap in symptom levels between patients with and patients without indication for joint replacement ; indeed , it was not possible to determine cutpoints for pain and function defining this indication . The post hoc analysis of trial data showed that the prevalence of cases that combined radiological progression , high level of pain , and high degree of function impairment was low ( 2%–12 % ) . The most discriminatory cutpoint to define an indication for joint replacement was found to be [ pain ( 0–100 ) + physical function ( 0–100 ) > 80 ] . Conclusion . These results do not support a specific level of pain or function that defines an indication for joint replacement . However , a tentative cutpoint for pain and physical function levels is proposed for further evaluation . Potentially , this symptom level , coupled with radiographic progression , could be used to define “ nonresponders ” to disease-modifying drugs in OA clinical trials",
"In the absence of patellar resurfacing , we have previously shown that the use of electrocautery around the margin of the patella improved the one-year clinical outcome of total knee replacement ( TKR ) . In this prospect i ve r and omised study we compared the mean 3.7 year ( 1.1 to 4.2 ) clinical outcomes of 300 TKRs performed with and without electrocautery of the patellar rim : this is an up date of a previous report . The overall prevalence of anterior knee pain was 32 % ( 95 % confidence intervals [ CI ] 26 to 39 ) , and 26 % ( 95 % CI 18 to 35 ) in the intervention group compared with 38 % ( 95 % CI 29 to 48 ) in the control group ( chi-squared test ; p = 0.06 ) . The overall prevalence of anterior knee pain remained unchanged between the one-year and 3.7 year follow-up ( chi-squared test ; p = 0.12 ) . The mean total Western Ontario McMasters Universities Osteoarthritis Indices and the American Knee Society knee and function scores at 3.7 years ' follow-up were similar in the intervention and control groups ( repeated measures analysis of variance p = 0.43 , p = 0.09 and p = 0.59 , respectively ) . There were no complications . A total of ten patients ( intervention group three , control group seven ) required secondary patellar resurfacing after the first year . Our study suggests that the improved clinical outcome with electrocautery denervation compared with no electrocautery is not maintained at a mean of 3.7 years ' follow-up",
"Mobile-bearing unicompartmental knee replacements ( UKRs ) with a flat tibial plateau have not performed well in the lateral compartment , owing to a high dislocation rate . This led to the development of the Domed Lateral Oxford UKR ( Domed OUKR ) with a biconcave bearing . The aim of this study was to assess the survival and clinical outcomes of the Domed OUKR in a large patient cohort in the medium term . We prospect ively evaluated 265 consecutive knees with isolated disease of the lateral compartment and a mean age at surgery of 64 years ( 32 to 90 ) . At a mean follow-up of four years ( sd 2.2 , ( 0.5 to 8.3 ) ) the mean Oxford knee score was 40 out of 48 ( sd 7.4 ) . A total of 12 knees ( 4.5 % ) [ corrected ] had re-operations , of which four ( 1.5 % ) were for dislocation . All dislocations occurred in the first two years . Two ( 0.8 % ) were secondary to significant trauma that result ed in ruptured ligaments , and two ( 0.8 % ) were spontaneous . In four patients ( 1.5 % ) the UKR was converted to a primary TKR . Survival at eight years , with failure defined as any revision , was 92.1 % ( 95 % confidence interval 81.3 to 100 ) . The Domed Lateral OUKR gives good clinical outcomes , low re-operation and revision rates and a low dislocation rate in patients with isolated lateral compartmental disease , in the h and s of the design er surgeons",
"Abstract Purpose Mobile bearing ( MB ) knee prostheses were design ed to improve the performances of the total knee arthroplasties ( TKA ) . The clinical superiority of MB prosthesis compared to its fixed bearing counterpart has remained elusive . This study prospect ively evaluates the cumulative survivorship , clinical , radiographic results , and complications of a large series of MB TKAs in relation to patient age , sex , severity of arthritis , and patellar resurfacing . Methods This study evaluates the 5- to 10-year cumulative survival rate of the NexGen ® LPS MB . Between 2000 and 2005 , we performed a consecutive series of 332 MB , posterior-stabilized TKA in 249 patients ( mean age 71.2 years , SD 6.9 ) . The implants were clinical ly evaluated with the Hospital Special Surgery Knee Score ( HSS-KS ) and radiographically with the Knee Society Roentgenographic Evaluation System ( KS-RES ) . The mean follow-up was 76.3 months ( minimum 5 years ) . Results The HSS-KS improved from 55 pre-operatively to 86 at the end of follow-up . According to the KS-RES , the implants were anatomically aligned and progressive radiolucent lines appeared in four knees ( 1.2 % ) . The patella was selectively resurfaced in 162 of 332 knees . Patients with the patella resurfaced had better clinical results compared to those not resurfaced , but there was no difference in terms of survival . The cumulative survival rate was 98.4 % at 10 years ( Kaplan – Meier ’s analysis ) . Conclusions This MB implant provided reliable and durable clinical results with a survivorship of over 98 % at 10 years , in unselected patients regardless of age , sex , severity of disease , and patellar treatment . Level of evidence Therapeutic study , retrospective study ( data collected prospect ively ) , case series with no comparison group , Level IV",
"Objectives : Ketamine and nefopam has been documented to decrease pain intensity and improve rehabilitation after total knee arthroplasty ( TKA ) . We conducted a follow-up study of a previously r and omized clinical trial to determine the prevalence and risk factors of chronic pain 1 year after TKA and to assess the role of perioperative administration of ketamine and nefopam . Material s and Methods : The original r and omized , double-blind trial evaluated postoperative pain in 75 patients scheduled for TKA who received either a 48-hour infusion of ketamine or nefopam compared with placebo . The current study has evaluated patients at 6 and 12 months for the presence of chronic pain defined as a visual analogue scale ≥40 mm during a stair-climbing test . Other outcomes were incidence of neuropathic pain evaluated ( DN4 score ) , active flexion of the knee , and functional outcome ( KOOS-PS score ) . Results : A total of 69 patients completed the trial . The prevalence of chronic pain at 12 months was 17.4 % ( 95 % confidence interval [ CI ] , 10.2%-27.9 % ) without difference between the ketamine ( 12.5 % ) , nefopam ( 13.7 % ) , and placebo groups ( 26.1 % ) . Prevalence of neuropathic pain was 10.2 % ( 95 % CI , 3%-17.3 % ) . Ketamine reduced DN4 scores ( P=0.02 ) , increased knee flexion ( P=0.0007 ) , and KOOS-PS scores ( P compared with placebo . A visual analogue scale score ≥60 mm in the postoperative period was the only risk factor associated with the occurrence of chronic pain ( odds ratio 4.54 ; 95 % CI , 1.17 - 17.67 ) . Discussion : After TKA , the intensity of postoperative pain is a risk factor of chronic pain on movement . Intraoperative ketamine seems to improve long-term results of rehabilitation in this setting",
"The purpose of this study was to compare the short-term changes in quality of life for patients younger than 80 years with those 80 years and older undergoing total knee arthroplasty ( TKA ) . It was hypothesized that patients 80 years and older had a similar quality of life after TKA compared with those younger than 80 years . All consecutive patients undergoing primary TKA were enrolled in this prospect i ve , comparative , prognostic ( level I evidence ) study and were stratified into 2 groups based on their age ( younger than 80 years and 80 years and older ) . Data on quality of life assessed using the Short Form 36 health survey were obtained preoperatively and 1 year postoperatively ( short-term follow-up ) and were compared between groups . A total of 328 ( 83.89 % ) patients younger than 80 years ( mean age , 70.7 years ) and 63 ( 16.11 % ) patients 80 years and older ( mean age , 82.1 years ) were included . No significant differences in preoperative quality of life were observed between groups . Postoperative physical function , vitality , social function , and physical component summary were lower in patients 80 years and older . Older patients had a lower difference between pre- and postoperative values in Short Form 36 physical function and role-emotional scores . Patients 80 years and older had a similar improvement in quality of life 1 year after TKA compared with patients younger than 80 years . Therefore , changes in quality of life justify TKA as a treatment option for elderly patients with end-stage knee osteoarthritis",
"OBJECTIVE To study patient-level improvements in pain and limitations of key activities of daily living ( ADLs ) after primary or revision total knee arthroplasty ( TKA ) . METHODS We analysed prospect ively collected data from the Mayo Clinic Total Joint Registry for improvements in index knee pain severity and limitations in three key ADLs ( walking , climbing stairs and rising from a chair ) from pre-operative to 2 and 5 years post-TKA . RESULTS The primary TKA cohort consisted of 7229 responders pre-operatively , 7139 at 2 years and 4234 at 5 years post-operatively . The revision TKA cohort consisted of 1206 responders pre-operatively , 1533 at 2 years and 881 at 5 years post-operatively . In the primary TKA cohort , important pain reduction to mild or no knee pain at 2 years was reported by 92 % with moderate pre-operative pain and 93 % with severe pre-operative pain ; respective proportions were 91 % and 91 % at 5 years follow-up . For revision TKA , respective proportions were 71 % and 66 % at 2 years and 68 % and 74 % at 5 years . Three per cent with no/mild pre-operative overall limitation and 19 % with moderate/severe pre-operative overall limitation had moderate/severe overall activity limitation 2 years post-operatively ; at 5 years the respective proportions were 4 % and 22 % . Respective proportions for revision TKA were up to 3 % and 32 % at 2 years and 4 % and 34 % at 5 years . CONCLUSION Our study provides comprehensive data for patient-level improvements in pain and key ADLs . These data can be used to inform patients pre-operatively of expected outcomes , based on pre-operative status , which may further help patients set realistic goals for improvements after TKA",
"Improvement in knee flexion is a major expectation for many patients undergoing total knee arthroplasty ( TKA ) . One hundred and twenty two patients were r and omized to receive a cruciate-retaining st and ard or high-flexion TKA . Range of motion ( ROM ) and functional outcomes were assessed . The high flexion implants had a greater intraoperative ROM than st and ard implants . The mean flexion preoperatively , intraoperatively and at the one year follow-up was 107.4 ° , 123.0 ° and 108.9 ° in the st and ard group and 109.9 ° , 129.1 ° and 109.7 ° in the high-flexion TKA group . These differences were not significant preoperatively and at follow-up , but intraoperatively ( P preoperative knee flexion was the only significant factor influencing knee flexion at follow-up . No differences in the Knee Society Score or SF 36 were observed",
" We prospect ively followed 171 patients who underwent bilateral unicompartmental knee replacement ( UKR ) over a period of two years . Of these , 124 ( 72.5 % ) underwent a simultaneous bilateral procedure and 47 ( 27.5 % ) underwent a staged procedure . The mean cumulative operating time and length of hospital stay were both shorter in the simultaneous group , by 22.5 minutes ( p mean reduction in haemoglobin level post-operatively was greater by 0.15 g/dl in the simultaneous group ( p = 0.023 ) , but this did not translate into a significant increase in the number of patients requiring blood transfusion ( p = 1.000 ) . The mean hospital cost was lower by $ 8892 in the simultaneous group ( p significant difference in the rate of complications between the groups , and at two-year follow-up there was no difference in the outcomes between the two groups . We conclude that simultaneous bilateral UKR can be recommended as an appropriate treatment for patients with bilateral medial compartment osteoarthritis of the knee",
"BACKGROUND A number of trials have shown improved radiological alignment following total knee arthroplasty using computer-assisted surgery ( CAS ) compared with conventional surgery . Few studies , however , have looked at functional outcomes . METHODS We prospect ively studied a cohort of 107 patients that underwent TKA by a single surgeon . Patients were r and omised into 3 groups : computer-assisted surgery for both the femur and the tibia , intramedullary guides for both the femur and the tibia , and an intramedullary guide for the femur and an extramedullary guide for the tibia . Patients were followed-up post-operatively with the Short Form Health Survey ( SF-12 ) and Oxford Knee Score ( OKS ) question naires . RESULTS At a median follow-up of 46 months ( range 30 - 69 months ) , there was a trend towards higher OKS results in the CAS group , with a mean score of 40.6 in the CAS group compared to 37.6 in the extramedullary group and 36.8 in the intramedullary group . The difference seen in the OKS between CAS and the conventional groups had a significant unadjusted p-value ( 0.024 ) , and approached significance when adjusted for age and sex ( 0.054 ) . There was a significant improvement in the OKS when the mechanical axis was within ±3 ° of neutral , versus those outside this range ( median of 41.0 compared to 38.3 , p=0.045 ) . DISCUSSION This study shows that clinical ly significant differences are being seen in functional scores of patients treated with CAS versus conventional guides , at medium-term follow up . Our findings reinforce the tenet that a coronal mechanical axis of within 3 ° of neutral equates to significantly better functional outcomes ",
"BACKGROUND There is conflicting evidence as to whether diabetes mellitus influences the functional outcome and patient satisfaction after a total knee replacement ( TKR ) . The aim of this study was to assess the effect of diabetes upon the Oxford knee score ( OKS ) , short form (SF)-12 , and patient satisfaction after TKR . METHODS Prospect i ve pre- and post-operative ( one year ) OKS and SF-12 scores for 2389 patients undergoing primary TKR were compiled , of which 275 ( 12 % ) patients suffered with diabetes . Patient satisfaction was assessed at one year . RESULTS Patients with diabetes were more likely to have a greater level of comorbidity ( p pre-operative OKS and SF-12 score ( p0.41 ) independent predictor of post-operative OKS or the SF-12 physical score on multivariable analysis . Although , factors more prevalent within the diabetic cohort ( heart disease , vascular disease , liver disease , anaemia , depression , back pain , worse pre-operative OKS and SF-12 score ) were found to be independent predictors of post-operative OKS and SF-12 physical score . Interestingly , diabetes was associated with a significantly greater improvement in mental wellbeing ( SF-12 mental component ) , which was confirmed on multivariable analysis . Patient satisfaction was not influenced by a concomitant diagnosis of diabetes ( p=0.57 ) . CONCLUSION The outcome of TKR as assessed by the OKS , SF-12 , and overall patient satisfaction rates are not influenced by diabetes per se , although factors more prevalent within this population result in a worse post-operative outcome . LEVEL OF EVIDENCE prospect i ve cohort study , level III",
"BACKGROUND Zirconium total knee arthroplasties theoretically have a low incidence of failure as they are low friction , hard wearing and hypoallergenic . We report the five year survival of 213 Profix zirconium total knee arthroplasties with a conforming all polyethylene tibial component . METHODS Data was collected prospect ively and multiple strict end points were used . SF12 and WOMAC scores were recorded pre-operatively , at three months , at twelve months , at 3 years and at 5 years . RESULTS Eight patients died and six were \" lost to follow-up \" . The remaining 199 knees were followed up for five years . The mean WOMAC score improved from 56 to 35 and the mean SF12 physical component score improved from 28 to 34 . The five year survival for failure due to implant related reasons was 99.5 % ( 95 % CI 97.4 - 100 ) . This was due to one tibial component becoming loose aseptically in year zero . CONCLUSIONS Our results demonstrate that the Profix zirconium total knee arthroplasty has a low medium term failure rate comparable to the best implants . Further research is needed to establish if the beneficial properties of zirconium improve long term implant survival",
"High flexion prostheses have been introduced to achieve high flexion and improve clinical outcomes . Controversy exists in the literature regarding outcomes of high flexion vs. st and ard implants . This multicenter study compares outcomes in patients receiving a high flexion prosthesis vs. st and ard prosthesis . 278 high flexion and st and ard knee prostheses were used . Patients were followed for two years and evaluated prospect ively . The mean HSS was 87.3 for the st and ard group and 88.9 for the flexion group . At two-year follow up the st and ard prosthesis group had mean flexion of 121 ° and the high flexion group had mean flexion 120 ° . No knee had aseptic loosening , infection , or osteolysis . At two-year follow up , there were no significant differences in range of motion , clinical outcome , or radiographic evaluation . Pre-operative motion and functional status have greater impact on clinical outcome than implant alone",
"We performed a r and omised controlled trial comparing computer-assisted surgery ( CAS ) with conventional surgery ( CONV ) in total knee replacement ( TKR ) . Between 2009 and 2011 a total of 192 patients with a mean age of 68 years ( 55 to 85 ) with osteoarthritis or arthritic disease of the knee were recruited from four Norwegian hospitals . At three months follow-up , functional results were marginally better for the CAS group . Mean differences ( MD ) in favour of CAS were found for the Knee Society function score ( MD : 5.9 , 95 % confidence interval ( CI ) 0.3 to 11.4 , p = 0.039 ) , the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) subscales for ' pain ' ( MD : 7.7 , 95 % CI 1.7 to 13.6 , p = 0.012 ) , ' sports ' ( MD : 13.5 , 95 % CI 5.6 to 21.4 , p = 0.001 ) and ' quality of life ' ( MD : 7.2 , 95 % CI 0.1 to 14.3 , p = 0.046 ) . At one-year follow-up , differences favouring CAS were found for KOOS ' sports ' ( MD : 11.0 , 95 % CI 3.0 to 19.0 , p = 0.007 ) and KOOS ' symptoms ' ( MD : 6.7 , 95 % CI 0.5 to 13.0 , p = 0.035 ) . The use of CAS result ed in fewer outliers in frontal alignment ( > 3 ° malalignment ) , both for the entire TKR ( 37.9 % vs. 17.9 % , p = 0.042 ) and for the tibial component separately ( 28.4 % vs 6.3 % , p = 0.002 ) . Tibial slope was better achieved with CAS ( 58.9 % vs. 26.3 % , p was 20 minutes longer with CAS . In conclusion , functional results were , statistically , marginally in favour of CAS . Also , CAS was more predictable than CONV for mechanical alignment and positioning of the prosthesis . However , the long-term outcomes must be further investigated",
"Background Modular tibial trays have been utilized in TKA for more than 20 years . However , concerns have been raised about modular implants and it is unclear whether these devices are durable in the long term . Questions / purpose sWe determined ( 1 ) survival , ( 2 ) relationship of age and polyethylene thickness with revision , ( 3 ) function , and ( 4 ) radiographic lucencies and osteolysis in patients having a single TKA implant at 20-year followup . Methods We prospect ively followed 75 patients implanted with 101 Press-Fit Condylar ® ( Johnson and Johnson Professional , Inc , Raynham , MA , USA ) posterior cruciate-retaining TKAs ( with modular tibial trays ) between 1988 and 1991 . At 20 years , 59 patients were deceased . We clinical ly evaluated the living 16 patients ( 22 knees ) and contacted the relatives of all deceased patients to confirm implant status . We clinical ly assessed 14 of the 16 patients with the Knee Society score , WOMAC , and UCLA and Tegner activity level scores . Radiographically , we determined lucencies , component migration , and osteolysis . We performed survival analysis including all original patients . Minimum followup was 20 years ( mean , 20.6 years ; range , 20–21.8 years ) . Results Six reoperations were performed in five patients ( 6 % rate of revision ) over the 20-year followup . All revisions were related to polyethylene wear and occurred at least 10 years after the primary procedure . Survivorship with revision for any reason as the end point was 91 % ( 95 % CI , 0.83–0.97 ) at 20 years . Average Knee Society clinical and functional scores were 90 ( range , 60–100 ) and 59 ( range , 30–87 ) , respectively . Conclusions Our data demonstrate the durability of this posterior cruciate-retaining TKA design . The data provide a st and ard for newer design s and newer bearing surface material s at comparable followup . Level of Evidence Level IV , therapeutic study . See Instructions for Authors for a complete description of levels of evidence",
"BACKGROUND A subset of patients with total hip arthroplasty ( THA ) or total knee arthroplasty ( TKA ) has suboptimal postoperative results in terms of Patient Reported Outcomes ( PROs ) , and psychological factors could contribute to these suboptimal results . OBJECTIVES To examine the prevalence of anxiety and depressive symptoms in patients undergoing primary THA or TKA preoperatively and postoperatively , and the relationship between preoperative anxiety and depressive symptoms on PROs of THA and TKA . DESIGN In this prospect i ve study patients were measured preoperatively , and 3 and 12 months postoperatively . Patients filled in the Hospital Anxiety and Depression Scale , Knee injury and Osteoarthritis Outcome Score ( KOOS ) or Hip disability and Osteoarthritis Outcome Score ( HOOS ) and a satisfaction question naire . RESULTS Data were obtained from 149 hip and 133 knee patients . The prevalence of anxiety symptoms decreased significantly from 27.9 % to 10.8 % 12 months postoperatively in hip patients , and from 20.3 % to 14.8 % in knee patients . Depressive symptoms decreased significantly from 33.6 % to 12.1 % 12 months postoperatively in hip patients , and from 22.7 % to 11.7 % in knee patients . In hip and knee patients , preoperative depressive symptoms predicted smaller changes in different HOOS or KOOS subscales and patients were less satisfied 12 months postoperatively . CONCLUSIONS Preoperatively , the prevalence of anxiety and depressive symptoms was high . At 3 and 12 months postoperatively , the prevalence of anxiety and depressive symptoms was decreased in both hip and knee patients . However , patients with preoperative anxiety and depressive symptoms had worse PROs 3 and 12 months after THA and TKA and were less satisfied than patients without anxiety or depressive symptoms",
"Extramedullary ( EM ) tibial alignment guides have demonstrated a limited degree of accuracy in total knee arthroplasty ( TKA ) . The purpose of this study was to compare the tibial component alignment obtained using a portable , accelerometer-based navigation device versus EM alignment guides . One hundred patients were enrolled in this prospect i ve , r and omized controlled study to receive a TKA using either the navigation device , or an EM guide . St and ing AP hip-to-ankle and lateral knee-to-ankle radiographs were obtained at the first , postoperative visit . 95.7 % of tibial components in the navigation cohort were within 2 ° of perpendicular to the tibial mechanical axis , versus 68.1 % in the EM cohort ( P outliers in tibial component alignment compared to conventional , EM alignment guides in TKA",
"BACKGROUND The purpose of this paper was to document the incidence of leg length changes after revision total knee arthroplasty ( TKA ) and its effect on clinical outcome . METHODS Leg length difference ( LLD ) was prospect ively measured in 85 patients using digital st and ing full leg radiography before and after revision TKA . Additionally the patient 's subjective perception of LLD was assessed postoperatively . Linear regression models were used to study the correlation between each of these parameters and the clinical outcome after 1 year . Clinical outcome was evaluated by means of the Knee Society Score ( KSS ) . RESULTS Revision TKA result ed on average in an increased leg length of 5.3 mm . Sixty-five legs ( 76 % ) were lengthened with the procedure , 17 ( 20 % ) were shortened and three ( 4 % ) remained of identical length . Increased leg length after revision was positively correlated with clinical outcome at 3 months ( Spearman r=0.22 , p=0.044 ) and 1 year ( Spearman r=0.26 , p=0.027 ) . The evidence for this correlation remained after correction for age , gender and diagnosis ( p=0.012 ) . The most important contributors to improved clinical outcome scores were improved pain score ( Spearman r=0.19 , p=0.09 ) and increased stability ( Spearman r=0.13 , p=0.24 ) , rather than range of motion ( Spearman r=-0.02 , p=0.85 ) . CONCLUSIONS The results from our work indicate that revision TKA tends to lengthen the leg by approximately 5 mm . Contrary to what might be expected , leg lengthening after revision TKA is correlated with improved clinical outcome . LEVEL OF EVIDENCE Level 2b",
"Purpose The aim of this study was to identify the minimal clinical ly important difference ( MCID ) in the Oxford knee score ( OKS ) and Short Form ( SF- ) 12 score after total knee arthroplasty ( TKA ) . Methods Prospect i ve pre-operative and 1 year post-operative OKS and SF-12 scores for 505 patients undergoing a primary TKA for osteoarthritis were collected during a one-year period . Patient satisfaction with their ( 1 ) patient relief and ( 2 ) functional outcome was used as the anchor questions . Their response to each question was recorded using a 5-point Likert scale : excellent , very well , well , fair , and poor . Simple linear regression was used to calculate the MCID for improvement in the OKS and physical component of the SF-12 score according to the level of patient satisfaction with their pain relief and function . Results The OKS improved by 15.5 ( 95 % CI 14.7–16.4 ) points and the SF-12 physical component score improved by 10.1 ( 95 % CI 9.1–11.2 ) points for the study cohort . The level of patient satisfaction with their pain relief and function correlated with the improvement in the OKS ( r = 0.56 ; p physical component of the SF-12 score ( r = 0.51 ; p MCID for the OKS was 5.0 ( 95 % CI 4.4–5.5 ) and 4.3 ( 95 % CI 3.8–4.8 ) points and for the physical component of the SF-12 , it was 4.5 ( 95 % CI 3.9–5.2 ) and 4.8 ( 95 % CI 4.2–5.4 ) points for pain relief and function , respectively . Conclusion The MCID identified for the OKS and SF-12 physical component score after TKA is the best available estimate and can be used to power studies and ensure that a statistical difference is also recognised by a patient . Level of evidence Retrospective diagnostic study , Level III",
"BACKGROUND The use of antibiotic-loaded cement is believed to prevent infection in primary total knee arthroplasty , but there is a lack of r and omized studies to support this concept . The aim of this study was to evaluate the use of an antibiotic-loaded cement to reduce the infection rate in primary total knee arthroplasty . METHODS This is a prospect i ve r and omized study with 2948 cemented total knee arthroplasties , in which bone cement without antibiotic was used in 1465 knees ( the control group ) and a bone cement loaded with erythromycin and colistin was used in 1483 knees ( the study group ) . All patients received the same systemic prophylactic antibiotics . The patients were followed for a minimum of twelve months . The rate of infection was analyzed according to the criteria of the Centers for Disease Control and Prevention . RESULTS The rate of deep infection ( 1.4 % in the control group and 1.35 % in the study group ; p = 0.96 ) and the rate of superficial infection ( 1.2 % and 1.8 % , respectively ; p = 0.53 ) were similar in both groups . The factors related to a higher rate of deep infection in a multivariate analysis were male sex and an operating time of > 125 minutes . CONCLUSIONS The use of erythromycin and colistin-loaded bone cement in total knee arthroplasty did not lead to a decrease in the rate of infection when systemic prophylactic antibiotics were used , a finding that suggests that the use of antibiotic-loaded bone cement would not be indicated in the general population . Further research is needed to assess whether its use is recommended for patients with a higher risk of infection",
" From March 2006 to August 2008 , 93 subjects ( 186 knees ) underwent simultaneous bilateral total knee arthroplasty performed by eight surgeons at North American centers . This r and omized study was conducted to determine whether non-weight-bearing passive flexion was superior for knees receiving a posterior stabilized high flexion device compared to a posterior stabilized st and ard device in the contra-lateral knee . Weight-bearing single leg active flexion was one secondary endpoint . Follow-up compliance was 92.5 % . Results show small , but significant superiority in the motion metrics for the high flexion device compared to the st and ard device 12 months after surgery , especially for a subgroup of patients with pre-operative flexion less than 120 ° in both knees . Thus , the ideal c and i date for the high flexion device may be one with lesser pre-operative flexion ",
"Background Preoperative psychologic distress is considered to be a risk factor for clinical dissatisfaction stemming from persistent pain and physical limitations after elective orthopaedic procedures such as lower-extremity arthroplasty . However , the degree to which psychologic distress , specifically in the form of anxiety and depression , influences surgical results has been poorly characterized . Questions / purpose sWe analyzed the effect of preoperative psychologic distress on changes in pain , function , and quality of life 1 year after elective TKA . Methods In this prospect i ve cohort study , we assessed patients who underwent TKAs in 2009 and 2010 . Before surgery , patients completed the Folstein Mini Mental Test , the Hospital Anxiety and Depression Scale ( HAD ) , The Knee Society Score © , the WOMAC quality -of-life question naire , and the VAS for pain . The patients were divided into two groups based on the degree of psychologic distress on the HAD Scale , and the groups were compared in terms of the above-listed clinical outcomes tools 1 year after surgery using multivariate linear models . Two hundred sixty-three patients met the inclusion criteria , and 202 ( 77 % ) completed the study protocol . Results The presence of preoperative psychologic distress did not influence 1-year postoperative pain assessment ( average reduction in pain , 40.33 ; 95 % CI , 36.9–43.8 ; p = 0.18 ) . The only factor influencing change in pain experienced by patients was the preoperative pain recorded ( R2 = 0.31 ; β = −0.82 ; p poorer outcomes in function ( R2 = 0.16 ; β = −5.62 ; p = 0.001 ) and quality of life ( R2 = 0.09 ; β = −0.46 ; p 1-year outcomes for function and quality of life in patients undergoing TKA . Interventions design ed to reduce psychologic distress may be indicated for patients to undergo this type of surgery , and incorporation of these data into discussion s with patients may facilitate informed and shared decision making regarding the surgical treatment of knee osteoarthritis . Level of Evidence Level II , therapeutic study . See the Instructions for Authors for a complete description of levels of evidence",
"We have compared the time to recovery of isokinetic quadriceps strength after total knee replacement ( TKR ) using three different lengths of incision in the quadriceps . We prospect ively r and omised 60 patients into one of the three groups according to the length of incision in the quadriceps above the upper border of the patella ( 2 cm , 4 cm or 6 cm ) . The strength of the knees was measured pre-operatively and every month post-operatively until the peak quadriceps torque returned to its pre-operative level . There was no significant difference in the mean operating time , blood loss , hospital stay , alignment or pre-operative isokinetic quadriceps strength between the three groups . Using the Kaplan-Meier method , group A had a similar mean recovery time to group B ( 2.0 ± 0.2 vs 2.5 ± 0.2 months , p = 0.176 ) . Group C required a significantly longer recovery time ( 3.4 ± 0.3 months ) than the other groups ( p the mean Oxford knee scores one year post-operatively between the groups . We conclude that an incision of up to 4 cm in the quadriceps does not delay the recovery of its isokinetic strength after TKR",
"There is a growing recognition that insufficient attention has been paid to the selection of the outcomes to measure in clinical trials and clinical audit . Outcomes need to be relevant to patients , clinicians , purchasers and policy-makers if the findings of research are to influence practice and future research . In addition , st and ardization of outcomes is needed to combine data from different studies to allow evidence synthesis and to compare data sets . Inconsistent choice of outcome measures means that many meta-analyses are unable to include data from all the relevant studies . For example , the five most accessed Cochrane review s in 2009 , together with the top cited review in that year , all described inconsistencies in the outcomes reported in eligible trials . A call for the st and ardization of outcomes is a regular conclusion of systematic review s. Furthermore , outcome reporting bias , defined as the bias arising from selecting outcomes for publication based on the results , affects many r and omized trials and ‘ is an under-recognized problem that affects the conclusions in a substantial proportion of Cochrane review s ’ . That bias is likely to affect systematic review s more widely as well as affecting individual studies when considered on their own . Similar problems occur with clinical audit , highlighting the importance of establishing national audits that use and report the same outcomes for all participants . All these issues could be addressed with the development and application of agreed st and ardized sets of outcomes that have been termed ‘ core outcome sets ’ . These should be measured and reported , as a minimum , in all relevant clinical trials and national clinical audits for a specific condition . Adopting a core outcome set does not imply that a particular study , review or audit should be restricted to only those outcomes . Rather , the expectation is that , as a minimum , core outcomes will always be collected and reported to allow the results of trials to be compared , contrasted and combined as appropriate . The adoption of core outcomes would have implication s across all areas of research in health and health care , reduce heterogeneity between trials , and lead to research that is more likely to have measured relevant outcomes . Importantly , they would enhance the value of evidence synthesis by reducing the risk of outcome reporting bias and ensuring that all trials contribute usable information . In addition , they will increase the efficiency and value of research . An important rationale for core outcome sets is that outcomes currently reported for trials do not consistently reflect endpoints that are meaningful for patients . Examples exist where trials failed to include all outcomes important to patients and where involvement of patients has identified an outcome that might not have been considered by practitioners on their own . Despite increasing recognition of the importance of incorporating patients ’ opinions , their involvement has been limited . Recent regulatory guidance in the USA requires documented evidence of patient input during the development of instruments to measure patient reported outcomes ( PROs ) . However , measurement of PROs in clinical trials is hampered by the multiplicity and heterogeneity of tools currently available . Many generic , disease and domain-specific instruments have been developed and vali date d , each containing multiple scales and items . As a result , synthesis of PRO data from trials is difficult and review s aim ing to summarize treatment effect according to PROs may fail . There is synergy between the development of core outcome sets for trials and work to select up to seven outcomes that are important to patients for inclusion in Summary of Findings tables in systematic review s. Developed by the GRADE group ( http://www . grade workinggroup.org ) , Cochrane review s have featured such tables since 2008 , and they play a key role in presenting research in guidelines , such as those produced by the World Health Organization ( WHO ) . The development of core outcome sets needs to be accelerated and undertaken in ways that maximize efficiency . The COMET ( Core Outcome Measures in Effectiveness Trials , http://www.comet-initiative.org ) Initiative in the UK brings together research ers interested in the development and application of core outcome sets . These include key participants in a collaboration of research ers in rheumatology who have done the most notable work to date in this area . The COMET Initiative was launched in January 2010 , with a second meeting in July 2011 . Attendees included trialists , systematic review ers , patients , clinicians , journal editors , research funders , policy-makers , people responsible for trials registries and regulators . Data on individual studies , both published and ongoing , are being included in a free , publically available internet-based re source . This will be up date d periodically , to minimize the risk of duplication . Seventy-eight published or ongoing studies have already been entered into the repository . In addition , published review s of outcomes used in clinical trials or studies examining patients ’ views , will be entered",
"BACKGROUND Fixed bearing ( FB ) total knee replacement is a well established technique against which new techniques must be compared . Mobile bearing ( MB ) prostheses , in theory , reduce polyethylene wear but the literature is yet to provide evidence that they are superior in terms of function or long-term survivorship . In addition there has been no comparison of patella resurfacing on the outcome of either design . The aims of this r and omised prospect i ve study were firstly to determine whether a mobile bearing prosthesis produced better clinical outcome and range of motion at two year follow-up and secondly to assess the effect of patella resurfacing on the outcomes of both types of bearing design . METHODS Three hundred fifty-two patients were r and omised into receiving either a PFC Sigma © cruciate sacrificing total knee arthroplasty either with a mobile bearing or a fixed bearing , with a sub-r and omisation to either patella resurfacing or patella retention . All patients participated with st and ard clinical outcome measures and had their range of motion measured both pre-operatively and at follow-up . RESULTS The mobile bearing TKR design had no impact on range of motion ; Oxford Knee Score and American Knee Society knee and function scores when compared to its fixed bearing equivalent . CONCLUSIONS At two year follow-up there was no difference between the PFC Sigma © fixed and mobile bearing design s. With no clinical difference between the cohorts , we can not recommend one design over the other . Long term benefits , particularly with regards to polyethylene wear , may yet be demonstrated . Level of evidence --1B",
"OBJECTIVES To define Patient Acceptable Symptom State ( PASS ) thresholds for the Oxford hip score ( OHS ) and Oxford knee score ( OKS ) at mid-term follow-up . METHODS In a prospect i ve multicentre cohort study , OHS and OKS were collected at a mean follow-up of three years ( 1.5 to 6.0 ) , combined with a numeric rating scale ( NRS ) for satisfaction and an external validation question assessing the patient 's willingness to undergo surgery again . A total of 550 patients underwent total hip replacement ( THR ) and 367 underwent total knee replacement ( TKR ) . RESULTS Receiver operating characteristic ( ROC ) curves identified a PASS threshold of 42 for the OHS after THR and 37 for the OKS after TKR . THR patients with an OHS ≥ 42 and TKR patients with an OKS ≥ 37 had a higher NRS for satisfaction and a greater likelihood of being willing to undergo surgery again . CONCLUSIONS PASS thresholds appear larger at mid-term follow-up than at six months after surgery . With- out external validation , we would advise against using these PASS thresholds as absolute thresholds in defining whether or not a patient has attained an acceptable symptom state after THR or TKR . Cite this article : Bone Joint Res 2014;3:7 - 13",
"It is not clear whether indicating TKA-surgery is advisable in depressed patients . A prospect i ve cohort of 716 patients undergoing TKA was design ed . SF36 , KSS , WOMAC and VAS plus 2 satisfaction questions were evaluated . There were 2 groups : 200 patients were depressed and 516 were not . Preoperative/postoperative results show better scores for non-depressed patients on almost every sub-scale . Nevertheless , net change results ( improvement ) were quite similar : 65.74 improvement in depressed-KSS and 74.58 in non-depressed ( P=0.049 ) ; 8.93 net change in depressed-Physical Composite Score and 11.84 in non-depressed ( P=0.003 ) ; 2.38 in depressed-Mental Composite Score and -0.61 in non-depressed ( P=0.024 ) . Depressed patients obtained great improvement from preoperative at one-year follow-up and even greater than non-depressed patients in some domains . Moreover , satisfaction was similar . Therefore , TKA can be recommended to depressed patients",
"A prospect i ve matched cohort study was performed to compare outcomes of cementless total knee arthroplasties between 171 knees in obese patients ( BMI ≥ 30 ) and 171 non-obese patients ( BMI Mean follow-up was 7 years . There were no significant differences in overall functional outcomes or components alignment . In the obese group , there were 14 perioperative complications , 9 revisions , and 5 other patients were considered clinical failures , whereas in the non-obese group there were 3 , 5 , and 7 , respectively . There were no significant differences between obese class I-II and class III ( morbid ) subgroups . The obese and non-obese groups had similar implant survivorship at 7 years . Although TKA outcome in obese was satisfactory , these patients should be informed of the perioperative risks , and advised to lose weight prior to surgery",
"Ethnic cultural dem and s of the patient have encouraged surgeons to use high-flexion design s. It has been speculated that these high-flexion design s may produce higher incidence of patellofemoral complications over conventional design s. We wish to report 5- to 7-year follow-up of this design with special emphasis on patellofemoral outcomes . We performed a prospect i ve study involving 159 patients who underwent computer-assisted simultaneous bilateral total knee arthroplasty ( TKA ) with high-flexion design . Patients were evaluated clinical ly using Knee Society score ( KSS ) , Western Ontario and McMaster University Osteoarthritis ( WOMAC ) score , and Hospital for Special Surgery patella score with a minimum follow-up period of 5 years . At last follow-up , mean scores were KSS ( 88.7 ) , WOMAC ( 48.5 ) , and HSS ( 86.7 ) . All the scores improved postoperatively . Average preoperative range of motion was 108 degrees , which improved to 132 degrees postoperatively . There was no evidence of loosening or spin out in our study . Our study shows that TKA done using high-flexion rotating platform design results in near normal patellofemoral tracking patterns with improvement in function . The level of evidence of the study is IV",
"PURPOSE In a prospect i ve study we evaluated outcomes of total knee arthroplasty ( TKA ) procedures in 62 patients with a follow up of 12 months to test our hypothesis that high-flexion CR ( cruciate retaining ) TKA provides a better range of motion and better outcome than st and ard CR design in Central European patients with their special problems and dem and s. METHODS Patients were r and omly divided into two groups ( high flex vs. st and ard ) . The outcome was determined by measuring maximum knee flexion and using the KS-score and the SF-36 score . RESULTS After 12 months ability to flex the knee significantly improved in both groups to 115 ° ( SD 11 ) in the high flex group versus 119 ° ( SD 12 ) in the st and ard group . There was no difference between the design s regarding maximum flexion ( p = 0.78 ) . Overall clinical rating scores significantly improved in both groups , but there was no difference between groups at one year after surgery ( p ( KSS ) = 0.7 and p ( SF-36 ) = 0.63 ) . KS-score values improved from 25 points to 89 points for st and ard TKAs and from 20 points to 90 points for high flex TKAs . SF-36-score \" Physical Functioning \" values improved from 33 points to 66 points for st and ard TKAs and from 27 points to 63 points for high flex TKAs . CONCLUSION Our results confirm known good results of the procedure and suggest that the benefit of high flex knee design s is similar to st and ard knee design s one year after index surgery . Further studies are required to evaluate long-term results of both design",
"This study assessed the effect of concomitant back pain on the Oxford knee score ( OKS ) , Short-Form (SF)-12 and patient satisfaction after total knee replacement ( TKR ) . It involved a prospect ively compiled data base of demographics and outcome scores for 2392 patients undergoing primary TKR , of whom 829 patients ( 35 % ) reported back pain . Compared with those patients without back pain , those with back pain were more likely to be female ( odds ratio ( OR ) 1.5 ( 95 % confidence interval ( CI ) 1.3 to 1.8 ) ) , have a greater level of comorbidity , a worse pre-operative OKS ( 2.3 points ( 95 % CI 1.7 to 3.0 ) ) and worse SF-12 physical ( 2.0 points ( 95 % CI 1.4 to 2.6 ) ) and mental ( 3.3 points ( 95 % CI 2.3 to 4.3 ) ) components . One year post-operatively , those with back pain had significantly worse outcome scores than those without with a mean difference in the OKS of 5 points ( 95 % CI 3.8 to 5.4 ) , in the SF-12 physical component of 6 points ( 95 % CI 5.4 to 7.1 ) and in the mental component of 4 points ( 95 % CI 3.1 to 4.9 ) . Patients with back pain were less likely to be satisfied ( OR 0.62 , 95 % CI 0.5 to 0.78 ) . After adjusting for confounding variables , concomitant back pain was an independent predictor of a worse post-operative OKS , and of dissatisfaction . Clinicians should be aware that patients suffering concomitant back pain pre-operatively are at an increased risk of being dissatisfied post-operatively",
"There is conflicting evidence about the merits of mobile bearings in total knee replacement , partly because most r and omised controlled trials ( RCTs ) have not been adequately powered . We report the results of a multicentre RCT of mobile versus fixed bearings . This was part of the knee arthroplasty trial ( KAT ) , where 539 patients were r and omly allocated to mobile or fixed bearings and analysed on an intention-to-treat basis . The primary outcome measure was the Oxford Knee Score ( OKS ) plus secondary measures including Short Form-12 , EuroQol EQ-5D , costs , cost-effectiveness and need for further surgery . There was no significant difference between the groups pre-operatively : mean OKS was 17.18 ( sd 7.60 ) in the mobile-bearing group and 16.49 ( sd 7.40 ) in the fixed-bearing group . At five years mean OKS was 33.19 ( sd 16.68 ) and 33.65 ( sd 9.68 ) , respectively . There was no significant difference between trial groups in OKS at five years ( -1.12 ( 95 % confidence interval -2.77 to 0.52 ) or any of the other outcome measures . Furthermore , there was no significant difference in the proportion of patients with knee-related re-operations or in total costs . In this appropriately powered RCT , over the first five years after total knee replacement functional outcomes , re-operation rates and healthcare costs appear to be the same irrespective of whether a mobile or fixed bearing is used",
"Background The infrapatellar fat pad is one of the structures that obscures exposure in minimally invasive total knee arthroplasty ( MIS TKA ) . Most MIS TKA surgeons ( and many surgeons who use other approaches as well ) excise the fat pad for better exposure of the knee . There is still controversy about the result of fat pad excision on patella baja , pain , and function . Questions / purpose sIn the setting of a r and omized controlled trial , we sought to determine whether infrapatellar fat pad excision during MIS TKA causes ( 1 ) patellar tendon shortening ( as measured by patella baja ) ; ( 2 ) increased anterior knee pain ; ( 3 ) decreases in the Knee Society Score or functional subscore ; or ( 4 ) more patella-related complications . Methods We r and omized 90 patients undergoing MIS TKA at one institution into two groups . In one group , 45 patients underwent MIS TKA with complete infrapatellar fat pad excision and in the other group , 45 patients received MIS TKA without infrapatellar fat pad excision . The patella was selectively resurfaced in these patients ; there was no difference between the groups in terms of the percentage of patients whose patellae were resurfaced . We measured patellar tendon shortening , knee flexion , anterior knee pain , Knee Society Score ( KSS ) , functional subscore , and patellar complications at preoperative and postoperative periods of 6 weeks , 3 months , 6 months , and 1 year ; complete followup data were available on 86 % of patients ( 77 of 90 ) who were enrolled . Results At the final followup , no significant differences were observed in patellar tendon shortening , KSS , functional subscore , or knee flexion in either group . However , patients with their infrapatellar fat pad excised experienced more anterior knee pain ( 8.3 % versus 0 % ; p = 0.03 ; 95 % confidence interval , −0.007 to 0.174 ) at the end of the study . No patellar complications were found in either group . Conclusions Infrapatellar fat pad excision in MIS TKA result ed in an increasing small percentage of patients with anterior knee pain after surgery . Surgeons should keep the fat pad if excellent exposure can be achieved but resect it if needed to improve exposure during TKA.Level of Evidence Level I , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence"
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CONTEXT International guidelines do not make any specific recommendations on Serenoa repens ( SeR ) for the treatment of male lower urinary tract symptoms ( LUTS ) secondary to benign prostatic enlargement ( BPE ) , due to product heterogeneity and method ological limitations of the published trials and meta-analyses . OBJECTIVE We aim ed to compare the clinical efficacy of hexanic extract of SeR ( HESr ) versus non-HESr ( nHESr ) versus placebo versus alpha-blockers ( ABs ) in patients affected by LUTS secondary to BPE through a network meta- analysis method . EVIDENCE ACQUISITION The search was conducted until December 31 , 2018 using Medline , Scopus , and Web of Science data bases without restriction . We included r and omized controlled trials ( RCTs ) with at least one comparison between SeR , ABs , or placebo for the treatment of LUTS/BPE . Outcomes of the study were the mean change in the International Prostate Symptom Score ( IPSS ) and peak flow ( PF ) . This systematic review has been registered on PROSPERO ( CRD42018084360 ) . EVIDENCE SYNTHESIS In total , 2115 articles were identified . After the global assessment , 22 RCTs matched with the inclusion criteria , including 8564 patients . For IPSS , the mean efficacies against placebo were + 0.48 and -1.69 for HESr and nHESr , respectively , at 3 mo ; 0.59 for nHESr at 6 mo ; and -1.31 and -3.30 for nHESr and HESr , respectively , at 12 mo . For PF , the mean efficacies against placebo were + 0.53 and + 2.82 for HESr and nHESr , respectively , at 3 mo ; + 1.85 for nHESr at 6 mo ; and + 4.05 and + 5.52 for HESr and nHESr , respectively , at 12 mo . Based on the surface under the cumulative ranking curve rankograms , terazosin showed the highest score ( 99.6 % ) , while alfuzosin , tamsulosin , silodosin , HESr , and nHESr showed scores of 53.7 % , 42.3 % , 68.5 % , 36.7 % , and 47.3 % , respectively . CONCLUSIONS In this network meta- analysis , we demonstrated that SeR did not show clinical ly meaningful improvement in LUTS and PF . PATIENT SUMMARY In the present study , we found no clinical ly meaningful improvement of Serenoa repens for the treatment of lower urinary tract symptoms/benign prostatic enlargement . The analysis showed that the benefit over placebo was minimal and may not justify its clinical use before higher level of evidence will be available
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"To compare in a r and omised , open‐label , non‐inferiority clinical study , the efficacy and tolerability of Serenoa repens ( SeR ) + selenium ( Se ) + lycopene ( Ly ) ( SeR‐Se‐Ly ) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms ( LUTS )",
"OBJECTIVES To assess the effects of saw palmetto on urinary symptoms , sexual function , and urinary flow rate in men with lower urinary tract symptoms using a double-blind , r and omized , placebo-controlled trial . METHODS The eligible patients were 45 years of age or older and had an International Prostate Symptom Score of 8 or greater . After a 1-month placebo run-in period , 85 men were r and omized to receive saw palmetto or placebo for 6 months . Patients were evaluated using the International Prostate Symptom Score , a sexual function question naire , and by measurement of the urinary flow rate . RESULTS The mean symptom score decreased from 16.7 to 12.3 in the saw palmetto group compared with 15.8 to 13.6 in the placebo group ( P = 0.038 ) . The quality -of-life score improved to a greater degree in the saw palmetto group , but this difference was not statistically significant . No change occurred in the sexual function question naire results in either group . The peak flow rate increased by 1.0 mL/s and 1.4 mL/s in the saw palmetto and placebo groups , respectively ( P = 0.73 ) . CONCLUSIONS Saw palmetto led to a statistically significant improvement in urinary symptoms in men with lower urinary tract symptoms compared with placebo . Saw palmetto had no measurable effect on the urinary flow rates . The mechanism by which saw palmetto improves urinary symptoms remains unknown",
"PURPOSE We tested the effects of a saw palmetto herbal blend in men with symptomatic benign prostatic hyperplasia ( BPH ) via a r and omized , placebo controlled trial . MATERIAL S AND METHODS We r and omized 44 men 45 to 80 years old with symptomatic BPH into a trial of a saw palmetto herbal blend versus placebo . End points included routine clinical measures ( symptom score , uroflowmetry and post-void residual urine volume ) , blood chemistry studies ( prostate specific antigen , sex hormones and multiphasic analysis ) , prostate volumetrics by magnetic resonance imaging , and prostate biopsy for zonal tissue morphometry and semiquantitative histology studies . RESULTS Saw palmetto herbal blend and placebo groups had improved clinical parameters with a slight advantage in the saw palmetto group ( not statistically significant ) . Neither prostate specific antigen nor prostate volume changed from baseline . Prostate epithelial contraction was noted , especially in the transition zone , where percent epithelium decreased from 17.8 % at baseline to 10.7 % after 6 months of saw palmetto herbal blend ( p percent of atrophic gl and s increased from 25 . 2 % to 40.9 % after treatment with saw palmetto herbal blend ( p apoptosis , cellular proliferation , angiogenesis , growth factors or and rogen receptor expression . We noted no adverse effects of saw palmetto herbal blend . When the study was no longer blinded , 41 men elected to continue therapy in an open label extension . CONCLUSIONS Saw palmetto herbal blend appears to be a safe , highly desirable option for men with moderately symptomatic BPH . The secondary outcome measures of clinical effect in our study were only slightly better for saw palmetto herbal blend than placebo ( not statistically significant ) . However , saw palmetto herbal blend therapy was associated with epithelial contraction , especially in the transition zone ( p < 0.01 ) , indicating a possible mechanism of action underlying the clinical significance detected in other studies",
"OBJECTIVES To present the results of a pooled analysis of three double-blind , placebo-controlled studies of doxazosin in benign prostatic hyperplasia ( BPH ) . Heterogeneous symptom and bother score data collected using different symptom indices were transformed to enable a comparison of the data and to conduct a pooled , in-depth analysis . METHODS Urinary flow rates , and symptom and bother score data were shown by analysis of covariance methods to give consistent estimates of the efficacy of doxazosin across different studies , thus confirming the validity of pooling the results . Prior to analysis , symptom and bother score data were transformed so that all scales started from zero ( least symptoms or bother ) and were expressed as a percentage of the maximum score . RESULTS Doxazosin produced a significantly greater improvement than placebo in peak urinary flow rate ( P = 0.0017 ) , symptom severity ( P bother caused by symptoms ( P doxazosin treatment by those with more severe symptoms at baseline ( P = 0.0001 ) . Stratification by age showed that age did not affect the capacity to benefit from treatment . Analysis of the pooled peak flow-rate data showed that doxazosin produced a consistently greater increase in flow compared with placebo . Doxazosin was well tolerated , with 10 % of patients having withdrawn due to adverse events versus 4 % with placebo ( P Doxazosin is well tolerated and effective in the treatment of BPH . Pooling of data has enabled more extensive and robust conclusions to be drawn than was possible for each one of the individual three studies",
"BACKGROUND / AIM It has been observed that a large number of patients with low urinary tract symptoms due to benign prostatic hyperplasia ( LUTS/BPH ) ) has been treated with a combination of tamsulosin ( TAM ) + Serenoa repens ( SR ) ( TAM + SR ) . The aim of this study was to compare a combination TAM + SR with TAM and SR alone , to see if there was any difference in efficacy and tolerance of each in patients with LUTS/BPH . METHODS In this prospect i ve study patients had to have prostate volume ( PV ) International Prostate Symptom Score ( IPSS ) of 7 - 18 , Quality of Life score ( QoLs ) > 3 , a maximal flow rate ( Qmax ) of 5 - 15 mL/s , with post voiding residual volume ( PVR ) TAM ( 0.4 mg ) was administered once a day , SR ( 320 mg ) daily or SR ( 320 mg ) + TAM ( 0.4 mg ) daily for a median period of 6 months . RESULTS A total of 297 patients were recruited , whereas 265 patients were fully available : 87 into the group TAM , 97 into the group SR and 81 into the group TAM + SR . There was no statistically significant difference between the treatment groups in the sense of demographic and other baseline parameters . No difference was found among the 3 treatment groups , neither in the major endpoint of the study in the sense of a change between baseline and final evaluation in total IPSS , obstructive and irritative subscores , improvement of QoLs , increase in Qmax , nor for the second endpoint including diminution of PV , PSA and PVR . During the treatment period 20 ( 23 % ) of the patients managed with TAM and 17 ( 21 % ) with TAM + SR had drug- treated with related adverse reactions . No adverse effect was detected in the group SR . CONCLUSION Treatment of BPH by both SR and TAM seems to be efficacious alone . None of them had superiority over another and , additionally , a combined therapy ( TAM + SR ) does not provide extra benefits . Furthermore , SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS/BPH",
"Background Chronic prostatic inflammation ( CPI ) could be a cause of symptomatic or complicated benign prostatic hyperplasia ( BPH ) . In previous in vitro and in vivo studies , Hexanic Extract of Serenoa repens ( HESr ) namely Permixon ® has demonstrated potent anti‐inflammatory properties . With the aim to provide new insight onto HESr anti‐inflammatory properties in human we explore its effect on CPI biomarkers in men with lower urinary tract symptoms ( LUTS ) related to BPH using a non‐invasive method and investigate links between biomarkers and clinical symptoms . Methods An international , r and omized , double‐blind , parallel‐group , tamsulosin‐controlled study was carried out in 206 men with BPH‐related LUTS . Patients received oral daily HESr 320 mg or tamsulosin 0.4 mg during 3 months . The first urine stream after digital rectal examination ( DRE ) was collected at Day 1 and Day 90 and mRNA was extracted from prostatic epithelial cells desquaming in the lumen of the gl and s and seminal plasma fluid after DRE . mRNA quantification of the 29 most significant published inflammation markers in BPH and protein detection in urine was performed . Results At D90 , a decrease in mean gene expression was observed for 65.4 % of the markers detected in the HESr group versus 46.2 % in the tamsulosin group . In the 15 most frequently expressed genes , this difference was higher ( 80 % vs. 33 % respectively ) . Three proteins ( MCP‐1/CCL2 , IP‐10/CXCL10 , and MIF ) were detected . At D90 , a decrease in the number of patients who expressed MCP‐1/CCL2 and IP‐10/CXCL10 was observed only in the HESr group . Moreover , MIF expression was significantly reduced by HESr compared with tamsulosin ( P = 0.007 ) . Finally , in contrast to tamsulosin , the subgroup of patients treated by HESr and who over expressed MIF at baseline , had a higher response to the International Prostate Symptom Score ( I‐PSS ) than those who did not over express this protein ( mean I‐PSS change : −6.4 vs. −4.5 respectively ) . As the study is exploratory , results should be confirmed in a powered clinical study . Conclusions These results showed for the first time at clinical level the anti‐inflammatory properties of HESr , already indicated in BPH‐related LUTS . Thus , HESr could be of interest to prevent unfavourable evolution in patients with CPI . Prostate 75:1857–1867 , 2015 . © 2015 The Authors . The Prostate Published by Wiley Periodicals ,",
"This study was to investigate the role of complementary and alternative medicine in the prevention and treatment of benign prostatic hyperplasia . For this purpose , a r and omized , double-blind , placebo-controlled trial was performed over 12 months on 47 benign prostatic hyperplasia patients with average age of 53.3 years and international prostate symptom score over 8 . Subjects received either sweet potato starch ( group A , placebo , 320 mg/day ) , pumpkin seed oil ( group B , 320 mg/day ) , saw palmetto oil ( group C , 320 mg/day ) or pumpkin seed oil plus saw palmetto oil ( group D , each 320 mg/day ) . International prostate symptom score , quality of life , serum prostate specific antigen , prostate volume and maximal urinary flow rate were measured . In groups B , C and D , the international prostate symptom score were reduced by 3 months . Quality of life score was improved after 6 months in group D , while those of groups B and C were improved after 3 months , compared to the baseline value . Serum prostate specific antigen was reduced only in group D after 3 months , but no difference was observed in prostate volume in all treatment groups . Maximal urinary flow rate were gradually improved in groups B and C , with statistical significance after 6 months in group B and after 12 months in group C. None of the parameters were significantly improved by combined treatment with pumpkin seed oil and saw palmetto oil . From these results , it is suggested that administrations of pumpkin seed oil and saw palmetto oil are clinical ly safe and may be effective as complementary and alternative medicine treatments for benign prostatic hyperplasia",
"Introduction Increasing attention has been focused on the use of phytotherapeutic agents to alleviate the symptoms of benign prostatic hyperplasia ( BPH ) in recent times . The best described and studied phytotherapeutic agent is Serenoa repens ( SR ) . Material s and methods This prospect i ve study was design ed to have 3 arms including SR 320 mg per day ( N = 20 ) , Tamsulosin ( TAM ) 0.4 mg per day ( N = 20 ) and SR + TAM ( N = 20 ) to reveal the superiority or equivalence between these treatment regimens in BPH . Results The groups were not statistically different with regard to increase in maximal urinary flow rate ( Qmax ) and decrease in International Prostate Symptom Score ( I-PSS ) ( P > 0.05 ) . No adverse effect was detected in SR therapy group . Conclusion Treatment of BPH by both SR and TAM seems to be effective alone . None of them had superiority to another and additionally , combined therapy ( SR + TAM ) does not provide extra benefits . Furthermore SR is a well-tolerated agent that can be used alternatively in the treatment of LUTS due to BPH",
"PURPOSE We determined the effect of Prostataplex in men with lower urinary tract symptoms associated with benign prostatic hyperplasia . MATERIAL S AND METHODS A total of 92 Chinese men between 49 and 75 years old with lower urinary tract symptoms were r and omly assigned in this double-blind , placebo controlled trial . The 46 patients in the intervention group were given 2 Prostataplex soft gels daily for 12 weeks , while the 46 in the control group were given 2 placebo soft gels for the same time . RESULTS The treated and control groups appeared to have more than a 95 % compliance rate , as judged by counting the remaining pills in the bottle collected at the end of trial months 1 to 3 . After 12 weeks of intervention the mean + /- SD maximum urinary flow rate was significantly higher in the treatment group than in the control group ( 14.07 + /- 2.56 vs 11.74 + /- 1.23 ml per second , p relative urinary resistance was significantly lower in the treatment group than in the control group ( 2.35 + /- 0.83 vs 3.02 + /- 1.18 , p = 0.002 ) . While there was no significant difference in mean prostate volume or International Prostate Symptom Score between the 2 groups , 18 of 46 patients ( 39.1 % ) in the treatment group showed an International Prostate Symptom Score improvement ( decrease of 3 or greater ) after intervention , whereas only 1 of 46 ( 2.2 % ) in the control group showed an International Prostate Symptom Score improvement ( chi-square test p Prostataplex may have short-term effects in improving symptoms and objective measures in Chinese men with lower urinary tract symptoms associated with benign prostatic hyperplasia",
"The up date d 2003 American Urological Association ( AUA ) Guidelines for the treatment of benign prostatic hyperplasia ( BPH ) are the culmination of an exhaustive effort predicated on scientifically accepted methods of review ing the medical literature . In this second publication of the guidelines , a multidisciplinary panel review ed a new meta- analysis of outcome data from the BPH literature from before and after 1994 . The major differences between the 2 guidelines are the changes in our underst and ing of the biology of the prostate and the introduction of new therapies . The vast majority of r and omized controlled trials , particularly with respect to minimally invasive therapies and progression of BPH , were performed after the release of the 1994 guidelines . Also , the most recent AUA panel carefully review ed unpublished data to make the guidelines as timely as possible . Studies that were subsequently published included those on the value of combination medical therapy for BPH . The panel agreed on up date d recommendations for the treatment of moderate-to-severe lower urinary tract symptoms associated with BPH , and diagnostic algorithms were revised . The durability and utility of the present guidelines should exceed that of its predecessor",
" BACKGROUND Phytotherapy has been used to treat patients with lower urinary tract symptoms ( LUTS ) . We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens ( SeR ) , Lycopene ( Ly ) , and Selenium ( Se ) + tamsulosin versus single therapies . METHODS PROCOMB trial ( IS RCT N78639965 ) was a r and omized double-blinded , double-dummy multicenter study of 225 patients between 55 and 80 years old , PSA ≤ 4 ng/ml , IPSS ≥12 , prostate volume ≤60 cc , Qmax ≤15 ml/sec , postvoid residual urine ( PVR ) A ( SeR-Se-Ly ) , group B ( tamsulosin 0.4 mg ) , group C ( SeR-Se-Ly + tamsulosin 0.4 mg ) . The primary endpoints of the study were the reduction of IPSS , PVR , and increase of Qmax in group C versus monotherapy groups . RESULTS The decrease for combination therapy was significantly greater versus group A ( P PVR from baseline to 6 months . A greater decrease in IPSS was observed for Group C versus group A ( P increase in Qmax versus group B ( P the changes of IPSS and Qmax were greater for Group C versus monotherapies ( each comparison for IPSS ( each comparison P CONCLUSION SeR-Se-Ly + tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS",
"This section contains papers from Japan , Austria , the UK , and joint papers from France , Denmark , Switzerl and , Australia and the USA . A wide variety of lower urinary tract topics is covered , from BPH to overactive bladder and urodynamic stress incontinence",
"To evaluate the efficacy and safety of two doses ( 10 and 15 mg ) of alfuzosin once daily and tamsulosin ( 0.4 mg ) once daily , compared with placebo , in men with benign prostatic hyperplasia ( BPH )",
"OBJECTIVES To examine the efficacy and safety of tadalafil in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia . METHODS Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were r and omized to once-daily placebo ( n=154 ) , tadalafil 2.5 mg ( n=151 ) , tadalafil 5.0 mg ( n=155 ) or tamsulosin 0.2 mg ( active control , n=152 ) for 12 weeks . RESULTS Total International Prostate Symptom Score least-squares mean changes from baseline to end-point significantly improved with tadalafil 2.5 mg ( -4.8 , P=0.003 ) and 5 mg ( -4.7 , P=0.004 ) versus placebo ( -3.0 ) . Significant improvement in the International Prostate Symptom Score versus placebo was observed earlier ( week 2 ) for tadalafil 5.0 mg than for tadalafil 2.5 mg ( week 8) . Significant improvements ( P tadalafil groups versus placebo were observed for the International Prostate Symptom Score voiding subscore , International Prostate Symptom Score Quality of Life , and for Patient and Clinician Global Impressions of Improvement . Significant improvements versus placebo were observed in the International Prostate Symptom Score storage subscore for tadalafil 5.0 mg ( -1.7 , P=0.021 ) , but not tadalafil 2.5 mg ( -1.5 , P=0.072 ) . No significant improvements in benign prostatic hyperplasia Impact Index or improvements in peak urinary flow rates were observed with tadalafil 2.5 mg or 5.0 mg versus placebo . Tamsulosin treatment result ed in significant improvements versus placebo across all efficacy parameters , except for peak urinary flow rates . Safety results were consistent with the known tadalafil and tamsulosin safety profiles . CONCLUSIONS Tadalafil once daily represents an effective and well tolerated medical treatment for Asian men presenting with lower urinary tract symptoms suggestive of benign prostatic hyperplasia",
"OBJECTIVES To assess the efficacy and safety , and determine the optimal dosage , of a once-daily ( OD ) formulation of the clinical ly uroselective alpha(1)-blocker , alfuzosin , in patients with lower urinary tract symptoms and symptomatic benign prostatic hyperplasia . METHODS Five hundred thirty-six patients were r and omized to receive alfuzosin ( 10 mg OD or 15 mg OD ) , without initial dose titration , or placebo in a 3-month double-blind trial conducted in North America . The primary efficacy criteria were improvement in symptoms ( International Prostate Symptom Score ) and peak urinary flow rate . RESULTS Alfuzosin was significantly more effective than placebo in improving the symptoms and peak urinary flow rate from the first follow-up visit ( day 28 ) . The mean change in the International Prostate Symptom Score from baseline at endpoint was -3.6 and -3.4 with alfuzosin 10 mg and 15 mg , respectively , compared with -1.6 with placebo ( alfuzosin 10 mg versus placebo , P = 0.001 ; alfuzosin 15 mg versus placebo , P = 0.004 ) . The median increase in the peak urinary flow rate was + 1.1 mL/s and + 1.0 mL/s with alfuzosin 10 mg and 15 mg , respectively , compared with 0.0 mL/s with placebo ( P = 0.0006 versus placebo for both dose groups ) . The patients ' quality of life also significantly improved with both alfuzosin doses . Overall , alfuzosin at both doses was well tolerated . The incidence of orthostatic hypotension as determined by systematic blood pressure measurements with both doses of alfuzosin was similar to placebo . No clinical ly relevant ejaculation disorders were observed with alfuzosin . CONCLUSIONS Alfuzosin 10 mg OD , administered without dose titration , provides effective relief from the symptoms of benign prostatic hyperplasia with no additional benefit from a 15-mg dose . It is well tolerated from a cardiovascular viewpoint and is not associated with abnormal ejaculation",
"OBJECTIVES To evaluate the efficacy and safety of two once-daily doses of tamsulosin , the first selective alpha1A-antagonist studied in clinical trials . METHODS Patients with benign prostatic hyperplasia ( BPH ) were r and omized to receive either tamsulosin ( 0.4 and 0.8 mg/day ) or placebo ( n = 756 ) . Primary efficacy parameters were improvement in the total American Urological Association ( AUA ) symptom score and peak urinary flow ( Qmax ) . Secondary efficacy parameters were improvement in measurements at individual double-blind visits corresponding to the primary efficacy parameters ; percentage of patients with a 3-mL/s increase in Qmax ; total AUA irritative , obstructive , and bother scores ; individual AUA symptom scores ; total , irritative , obstructive , and individual Boyarsky symptom scores ; average urinary flow rate and other uroflowmetric parameters ; and investigator 's global assessment . RESULTS Statistically significant improvements in all efficacy parameters were observed in tamsulosin-treated compared with placebo-treated patients . Additionally , the 0.4-mg/day dose demonstrated a rapid onset of action ( 4 to 8 hours ) based on Qmax after the first dose of double-blind medication . A review of the safety parameters demonstrated excellent tolerance at 1 week after the initial 0.4-mg/day dose and continued tolerance during the additional 12 weeks of 0.4- and 0.8-mg/day dosing . The incidence of positive orthostatic test results in the tamsulosin groups was comparable to that observed in the placebo group . Adverse events were comparable in the 0.4-mg/day tamsulosin and placebo groups and were somewhat higher in the 0.8-mg/day tamsulosin group . CONCLUSIONS Tamsulosin was effective , safe , and well tolerated in the target BPH population at both the 0.4- and 0.8-mg/day dose levels , without the blood pressure-lowering effects typical of nonselective alpha-adrenergic antagonists",
"BACKGROUND Men with benign prostatic hyperplasia can be treated with alpha 1-adrenergic-antagonist drugs that relax prostatic smooth muscle or with drugs that inhibit 5 alpha-reductase and therefore reduce tissue and rogen concentrations . However , the effects of the two types of drugs have not been compared . METHODS We compared the safety and efficacy of placebo , terazosin ( 10 mg daily ) , finasteride ( 5 mg daily ) , and the combination of both drugs in 1229 men with benign prostatic hyperplasia . American Urological Association symptom scores and peak urinary-flow rates were determined at base line and periodically for one year . RESULTS The mean changes from base line in the symptom scores in the placebo , finasteride , terazosin , and combination-therapy groups at one year were decreases of 2.6 , 3.2 , 6.1 , and 6.2 points , respectively ( P placebo ) . The mean changes at one year in the peak urinary-flow rates were increases of 1.4 , 1.6 , 2.7 , and 3.2 ml per second , respectively ( P terazosin and combination therapy with finasteride and with placebo ) . Finasteride had no more effect on either measure than placebo . In the placebo group , 1.6 percent of the men discontinued the study because of adverse effects , as did 4.8 to 7.8 percent of the men in the other three groups . CONCLUSIONS In men with benign prostatic hyperplasia , terazosin was effective therapy , whereas finasteride was not , and the combination of terazosin and finasteride was no more effective than terazosin alone",
"OBJECTIVES To assess the efficacy and safety of a new prolonged release formulation of the uroselective alpha(1)-blocker alfuzosin for a once-daily dosing regimen in patients with lower urinary tract symptoms ( LUTS ) suggestive of symptomatic benign prostatic hyperplasia ( BPH ) . METHODS After a 1-month run-in period , 447 patients were r and omly allocated in a double-blind placebo-controlled study to receive alfuzosin 10 mg once daily ( n = 143 ) , alfuzosin 2.5 mg thrice daily ( n = 150 ) or placebo ( n = 154 ) for 3 months . At inclusion , 46 % of the r and omised population had concomitant cardiovascular disease and 30 % received an antihypertensive treatment . Uroflowmetry was performed close to trough plasma concentration of alfuzosin once daily to demonstrate the 24-hour coverage with this formulation . RESULTS Both alfuzosin formulations significantly improved urinary symptoms versus placebo assessed using the International Prostate Symptom Score ( alfuzosin 10 mg once daily : -6.9 ; alfuzosin 2.5 mg thrice daily : -6.4 ; placebo : -4.9 , p = 0.005 ) . Peak flow rate increased significantly with alfuzosin 10 mg once daily ( + 2.3 ml/s , p = 0.03 vs. placebo ) and with alfuzosin 2.5 mg thrice daily ( + 3.2ml/s , p tolerated in comparison with placebo . In addition , vasodilatory adverse events appeared to be less frequent with the once daily than the thrice daily formulation ( 6.3 vs. 9.4 % , respectively ) . No first-day effect was reported with alfuzosin once daily and the effect on blood pressure did not differ from those observed in placebo , both in normotensive and hypertensive patients . No specific sexual dysfunction including ejaculation disorder was reported in the alfuzosin 10 mg once-daily group . CONCLUSION The new once-daily formulation of alfuzosin administered at a dose of 10 mg daily is an effective 24-hour treatment of LUTS associated with BPH . Alfuzosin is as effective as the immediate formulation and shows a better cardiovascular safety . The better safety profile enables the same dose to be used in all patients , providing the patients with the benefits of a once-daily administration",
"BACKGROUND Silodosin is a new selective therapy with a high pharmacologic selectivity for the α(1A)-adrenoreceptor . OBJECTIVE Our aim was to test silodosin 's superiority to placebo and noninferiority to tamsulosin and discuss the findings in the context of a comprehensive literature review of the new compound silodosin . DESIGN , SETTING , AND PARTICIPANTS We conducted a multicenter double-blind , placebo- and active-controlled parallel group study . A total of 1228 men ≥50 yr of age with an International Prostate Symptom Score ( IPSS ) ≥13 and a urine maximum flow rate ( Q(max ) ) > 4 and ≤15 ml/s were selected at 72 sites in 11 European countries . The patients were entered into a 2-wk wash-out and a 4-wk placebo run-in period . A total of 955 patients were r and omized ( 2:2:1 ) to silodosin 8 mg ( n=381 ) , tamsulosin 0.4 mg ( n=384 ) , or placebo ( n=190 ) once daily for 12 wk . MEASUREMENTS We calculated the change from baseline in IPSS total score ( primary ) , storage and voiding subscores , quality of life ( QoL ) due to urinary symptoms , and Q(max ) . Responders were defined on the basis of IPSS and Q(max ) by a decrease of ≥25 % and an increase of ≥30 % from baseline , respectively . RESULTS AND LIMITATIONS The change from baseline in the IPSS total score with silodosin and tamsulosin was significantly superior to that with placebo ( p with silodosin and -2.0 ( 95 % CI,-2.9 , -1.1 ) with tamsulosin . Responder rates according to total IPSS were significantly higher ( p superior to placebo in the IPSS storage and voiding subscore analyses , as well as in QoL due to urinary symptoms . Of note , only silodosin significantly reduced nocturia versus placebo ( the change from baseline was -0.9 , -0.8 , and -0.7 for silodosin , tamsulosin , and placebo , respectively ; p=0.013 for silodosin vs placebo ) . An increase in Q(max ) was observed in all groups . The adjusted mean change from baseline to end point was 3.77 ml/s for silodosin , 3.53 ml/s for tamsulosin , and 2.93 ml/s for placebo , but the change for silodosin and tamsulosin was not statistically significant versus placebo because of a particularly high placebo response ( silodosin vs placebo : p=0.089 ; tamsulosin vs placebo : p=0.221 ) . At end point , the percentage of responders by Q(max ) was 46.6 % , 46.5 % , and 40.5 % in the silodosin , tamsulosin , and placebo treatment groups , respectively . This difference was not statistically significantly ( p=0.155 silodosin vs placebo and p=0.141 tamsulosin vs placebo ) . Active treatments were well tolerated , and discontinuation rates due to adverse events were low in all groups ( 2.1 % , 1.0 % , and 1.6 % with silodosin , tamsulosin , and placebo , respectively ) . The most frequent adverse event with silodosin was a reduced or absent ejaculation during orgasm ( 14 % ) , a reversible effect as a consequence of the potent and selective α(1A)-adrenoreceptor antagonism of the drug . The incidence was higher than that observed with tamsulosin ( 2 % ) ; however , only 1.3 % of silodosin-treated patients discontinued treatment due to this adverse event . CONCLUSIONS Silodosin is an effective and well-tolerated treatment for the relief of both voiding and storage symptoms in patients with lower urinary tract symptoms suggestive of bladder outlet obstruction thought to be associated with benign prostatic hyperplasia . Its overall efficacy is not inferior to tamsulosin . Only silodosin showed a significant effect on nocturia over placebo . TRIAL REGISTRATION Clinical Trials.gov Identifier NCT00359905",
"CONTEXT Saw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia ( BPH ) ; however , recent clinical trials have question ed their efficacy , at least at st and ard doses ( 320 mg/d ) . OBJECTIVE To determine the effect of saw palmetto extract ( Serenoa repens , from saw palmetto berries ) at up to 3 times the st and ard dose on lower urinary tract symptoms attributed to BPH . DESIGN , SETTING , AND PARTICIPANTS A double-blind , multicenter , placebo-controlled r and omized trial at 11 North American clinical sites conducted between June 5 , 2008 , and October 10 , 2010 , of 369 men aged 45 years or older , with a peak urinary flow rate of at least 4 mL/s , an American Urological Association Symptom Index ( AUASI ) score of between 8 and 24 at 2 screening visits , and no exclusions . INTERVENTIONS One , 2 , and then 3 doses ( 320 mg/d ) of saw palmetto extract or placebo , with dose increases at 24 and 48 weeks . MAIN OUTCOME MEASURES Difference in AUASI score between baseline and 72 weeks . Secondary outcomes included measures of urinary bother , nocturia , peak uroflow , postvoid residual volume , prostate-specific antigen level , participants ' global assessment s , and indices of sexual function , continence , sleep quality , and prostatitis symptoms . RESULTS Between baseline and 72 weeks , mean AUASI scores decreased from 14.42 to 12.22 points ( -2.20 points ; 95 % CI , -3.04 to -1.36 ) [corrected]with saw palmetto extract and from 14.69 to 11.70 points ( -2.99 points ; 95 % CI , -3.81 to -2.17 ) with placebo . The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo ( upper bound of the 1-sided 95 % CI most favorable to saw palmetto extract was 1.77 points , 1-sided P = .91 ) . Saw palmetto extract was no more effective than placebo for any secondary outcome . No clearly attributable adverse effects were identified . CONCLUSION Increasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00603304"
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41172724-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE To assess the efficacy of probiotic therapies on body weight and BMI using a meta- analysis of r and omized , controlled trials . METHODS Twenty studies with 25 trials ( 1931 participants with age over 18 years ) were included . The pooled WMD was calculated by r and om effects model . RESULTS Probiotic consumption significantly reduced body weight by 0.59 kg ( 95 % CI , 0.30 - 0.87 ) and BMI by 0.49 kg/m(2 ) ( 95 % CI , 0.24 - 0.74 ) . A greater reduction in BMI was found with multiple species of probiotics . Subgroup analysis of trials with intervention duration ≥8 weeks found a more significant reduction in BMI . Limiting analysis to trials with a baseline BMI ≥25 kg/m(2 ) showed a greater reduction in BMI . CONCLUSION Consuming probiotics could reduce body weight and BMI , with a potentially greater effect when multiple species of probiotics were consumed , the duration of intervention was ≥8 weeks , or the objects were overweight
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"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 short-chain fatty acids formed in the human colon by the bacterial fermentation of fiber may have an antiinflammatory effect , may reduce insulin production , and may improve lipid metabolism . We previously showed in hypercholesterolemic patients that supplementation with the probiotic bacteria Lactobacillus plantarum 299v significantly lowers concentrations of LDL cholesterol and fibrinogen . OBJECTIVE We determined the influence of a functional food product containing L. plantarum 299v on lipid profiles , inflammatory markers , and monocyte function in heavy smokers . DESIGN Thirty-six healthy volunteers ( 18 women and 18 men ) aged 35 - 45 y participated in a controlled , r and omized , double-blind trial . The experimental group drank 400 mL/d of a rose-hip drink containing L. plantarum 299v ( 5 x 10(7 ) colony-forming units/mL ) ; the control group consumed the same volume of product without bacteria . The experiment lasted 6 wk and entailed no changes in lifestyle . RESULTS Significant decreases in systolic blood pressure ( P leptin ( P fibrinogen ( P F(2)-isoprostanes ( 37 % ) and interleukin 6 ( 42 % ) were also noted in the experimental group in comparison with baseline . Monocytes isolated from subjects treated with L. plantarum showed significantly reduced adhesion ( P L. plantarum administration leads to a reduction in cardiovascular disease risk factors and could be useful as a protective agent in the primary prevention of atherosclerosis in smokers",
"A placebo-controlled study was conducted to test the effect of Calpis ( Calpis Food Industry Co , Ltd , Tokyo , Japan ) sour milk , i.e. , a milk fermented with a starter containing Lactobacillus helveticus and Saccharomyces cerevisiae , on the blood pressure of 30 elderly hypertensive patients , most of whom were taking antihypertensive medication . Subjects were r and omly assigned to two groups . One group ingested daily 95 mL of the sour milk for 8 wk , and the other group ingested the same amount of artificially acidified milk as a placebo for 8 wk . In the sour-milk group , systolic blood pressure decreased significantly 4 and 8 wk after ingestion , by 9.4 + /- 3.6 mm Hg ( mean+/- SE , P diastolic blood pressure also decreased significantly , by 6.9 + /- 2.2 mm Hg ( P blood pressure were observed in the placebo group . The decrease in systolic and diastolic blood pressure in the sour-milk group tended to be greater than in the placebo group . No marked changes were observed in other indexes , including pulse rate , body weight , and blood serum variables in both groups",
"BACKGROUND & AIMS Radical radiation therapy is commonly used for treatment of pelvic cancer . Up to 80 % of patients receiving radiotherapy will develop acute radiation induced diarrhea . The primary aim of this r and omized double blind controlled trial is to evaluate the effect of the probiotic Bifilact ( ® ) on moderate and severe treatment-induced diarrhea during pelvic radiation . METHODS Patients with pelvic cancers were treated between 2006 and 2010 at L'Hôtel-Dieu de Québec , University Health Center . Some patients had surgery before pelvic radiotherapy and some received chemotherapy . A total of 246 Patients were r and omized between a placebo and either of two regiments of double strain Bifilact ( ® ) probiotics ( Lactobacillus acidophilus LAC-361 and Bifidobacterium longum BB-536 ) : a st and ard dose twice a day ( 1.3 billion CFU ) or a high dose three times a day ( 10 billion CFU ) . Patients were trained to record their digestive symptoms daily with a st and ardized scale and they met a registered dietician and radiation oncologist every week during treatment . The main analysis compared time to first appearance of grade ≥2 - 3 - 4 diarrhea using Kaplan-Meier curves as measured by proportion of patients without moderate and severe diarrhea . RESULTS 229 patients were analyzed . The difference between the groups for overall grade 2 - 3 - 4 diarrhea was not statistically significant ( p = 0.13 ) . However at 60 days , the proportion of patients without moderate and severe diarrhea in the st and ard dose group ( 35 % ) was more than twice as high as that of the placebo group ( 17 % ) with a hazard ratio of 0.69 ( p = 0.04 ) . In patients who had surgery , the st and ard probiotics dose group had a better proportion of patients without very severe diarrhea than the placebo group , respectively 97 % and 74 % ( p = 0.03 ) . In all groups , the average number of bowel movements per day during treatment was less than 3 soft stools ( p = 0.80 ) and the median abdominal pain less than 1 based on the National Cancer Institute scale ( p = 0.23 ) . CONCLUSION St and ard dose of Bifilact ( ® ) may reduce radiation induced grade 2 - 3 - 4 diarrhea at the end of the treatment of patients with pelvic cancer . In patients operated on before RT , a st and ard dose of probiotics may reduce radiation induced grade 4 diarrhea . Nutritional interventions by a registered dietician seemed to reduce global digestive symptoms . TRIAL REGISTRATION clinical trials.gov . Identifier NCT01839721",
"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 : Non-alcoholic steatohepatitis ( NASH ) is a clinicopathological entity that is being recognized more frequently in recent years . This study aim ed to evaluate the effects of Metformin , with and without a probiotic supplement on liver aminotransferases in patients with NASH . Methods : Sixty four patients 18 - 75 years with NASH confirmed by biopsy and histological assessment were enrolled to study . Patients were r and omized to one of the following treatments for 6 months : Group I , probiotic ( Protexin two tablets per day ) plus Metformin 500 mg two tablets per day ( Met/Pro ) , or group II , Metformin 500 mg two tablets per day plus two placebo tablet ( Met/P ) . After 6 month alanine aminotransferase ( ALT ) , aspartate aminotransferase , and ultrasound grading of NASH were assessed . Results : In group I , serum alanine aminotransferase ( ALT : 133.7 ± 70 vs. 45.2 ± 32.5 ; P 0.00 ) , and aspartate aminotransferase activity ( AST : 123.1 ± 72 vs. 44.2 ± 33.9 ; P and ultrasound grading of NASH ( P while serum alanine aminotransferase ( ALT ) was not significantly reduced ( 118.4 ± 67.9 vs. 112.5 ± 68.7 ; P ( AST : 125.3 ± 71 vs. 113.4 ± 71 ; P did fall significantly ( P fell significantly in both groups . Conclusions : Probiotic combination with Metformin improves liver aminotransferases better than metformin alone in patients with NASH",
"BACKGROUND Sulfonylurea drugs have been the only oral therapy available for patients with non-insulin-dependent diabetes mellitus ( NIDDM ) in the United States . Recently , however , metformin has been approved for the treatment of NIDDM . METHODS We performed two large , r and omized , parallel-group , double-blind , controlled studies in which metformin or another treatment was given for 29 weeks to moderately obese patients with NIDDM whose diabetes was inadequately controlled by diet ( protocol 1 : metformin vs. placebo ; 289 patients ) , or diet plus glyburide ( protocol 2 : metformin and glyburide vs. metformin vs. glyburide ; 632 patients ) . To determine efficacy we measured plasma glucose ( while the patients were fasting and after the oral administration of glucose ) , lactate , lipids , insulin , and glycosylated hemoglobin before , during , and at the end of the study . RESULTS In protocol 1 , at the end of the study the 143 patients in the metformin group , as compared with the 146 patients in the placebo group , had lower mean ( + /- SE ) fasting plasma glucose concentrations ( 189 + /- 5 vs. 244 + /- 6 mg per deciliter [ 10.6 + /- 0.3 vs. 13.7 + /- 0.3 mmol per liter ] , P glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8.6 + /- 0.2 percent , P 213 patients given metformin and glyburide , as compared with the 210 patients treated with glyburide alone , had lower mean fasting plasma glucose concentrations ( 187 + /- 4 vs. 261 + /- 4 mg per deciliter [ 10.5 + /- 0.2 vs. 14.6 + /- 0.2 mmol per liter ] , P glycosylated hemoglobin values ( 7.1 + /- 0.1 percent vs. 8.7 + /- 0.1 percent , P metformin alone was similar to that of glyburide alone . Eighteen percent of the patients given metformin and glyburide had symptoms compatible with hypoglycemia , as compared with 3 percent in the glyburide group and 2 percent in the metformin group . In both protocol s the patients given metformin had statistically significant decreases in plasma total and low-density lipoprotein cholesterol and triglyceride concentrations , whereas the values in the respective control groups did not change . There were no significant changes in fasting plasma lactate concentrations in any of the groups . CONCLUSIONS Metformin monotherapy and combination therapy with metformin and sulfonylurea are well tolerated and improve glycemic control and lipid concentrations in patients with NIDDM whose diabetes is poorly controlled with diet or sulfonylurea therapy alone",
"Abstract Throughout life , there is an aging of the immune system that causes impairment of its defense capability . Prevention or delay of this deterioration is considered crucial to maintain general health and increase longevity . We evaluated whether dietary supplementation with Lactobacillus delbrueckii subsp . bulgaricus 8481 could enhance the immune response in the elderly . This multi-center , double-blind , and placebo controlled study enrolled 61 elderly volunteers who were r and omly assigned to receive either placebo or probiotics . Each capsule of probiotics contained at least 3 × 107 L. delbrueckii subsp . bulgaricus 8481 . Individuals in the study were administered three capsules per day for 6 months . Blood sample s were obtained at baseline ( time 0 ) , end of month 3 , and month 6 . We characterized cell sub population s , measured cytokines by flow cytometry , quantified T cell receptor excision circle ( TREC ) by real-time PCR ( RT-PCR ) , and determined human β-defensin-2 ( hBD-2 ) concentrations and human cytomegalovirus ( CMV ) titers by enzyme-linked immunosorbent assay ( ELISA ) . Elderly responded to the intake of probiotic with an increase in the percentage of NK cells , an improvement in the parameters defining the immune risk profile ( IRP ) , and an increase in the T cell subsets that are less differentiated . The probiotic group also showed decreased concentrations of the pro-inflammatory cytokine IL-8 but increased antimicrobial peptide hBD-2 . These effects disappeared within 6 months of stopping the probiotic intake . Immunomodulation induced by L. delbrueckii subsp . bulgaricus 8481 could favor the maintenance of an adequate immune response , mainly by slowing the aging of the T cell sub population s and increasing the number of immature T cells which are potential responders to new antigens",
"Background / Objectives : In spite of the much evidence for the beneficial effects of probiotics , their anti-obesity effects have not been well examined . We evaluated the effects of the probiotic Lactobacillus gasseri SBT2055 ( LG2055 ) on abdominal adiposity , body weight and other body measures in adults with obese tendencies . Subjects/ Methods : We conducted a multicenter , double-blind , r and omized , placebo-controlled intervention trial . Subjects ( n=87 ) with higher body mass index ( BMI ) ( 24.2–30.7 kg/m2 ) and abdominal visceral fat area ( 81.2–178.5 cm2 ) were r and omly assigned to receive either fermented milk ( FM ) containing LG2055 ( active FM ; n=43 ) or FM without LG2055 ( control FM ; n=44 ) , and were asked to consume 200 g/day of FM for 12 weeks . Abdominal fat area was determined by computed tomography . Results : In the active FM group , abdominal visceral and subcutaneous fat areas significantly ( P respectively . Body weight and other measures also decreased significantly ( P : body weight , 1.4 % ( −1.1 ( −1.5 , −0.7 ) kg ) ; BMI , 1.5 % ( −0.4 ( −0.5 , −0.2 ) kg/m2 ) ; waist , 1.8 % ( −1.7 ( −2.1 , −1.4 ) cm ) ; hip , 1.5 % ( −1.5 ( −1.8 , −1.1 ) cm ) . In the control group , by contrast , none of these parameters decreased significantly . High-molecular weight adiponectin in serum increased significantly ( P on abdominal adiposity , body weight and other measures , suggesting its beneficial influence on metabolic disorders",
"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",
"Background The global p and emic of obesity has become a disastrous public health issue that needs urgent attention . Previous studies have concentrated in high-income urban setting s and few cover low-income rural setting s especially nomadic residents in mountain areas . This study focused on low-income rural and nomadic minority people residing in China ’s far west and investigated their prevalence and ethnic differences of obesity . Methods A question naire-based survey and physical examination of 8,036 individuals were conducted during 2009–2010 , using stratified cluster r and om sampling method in nomadic Kazakhs and rural Uyghur residents ( ≥18 years old ) in 18 villages , Xinjiang , China , about 4,407 km away from capital Beijing . Obesity was defined by BMI and WC . Results The overall prevalence of general and abdominal obesity in Kazakh adults were 18.3 % and 60.0 % , respectively and in Uyghur , 7.6 % and 54.5 % , respectively . Female ’s prevalence of obesity was higher than male ’s for general obesity ( 45–54 age group in Uyghur , P = 0.041 ) and abdominal obesity ( ≥55 years in Kazakhs , P55∼ = 0.010 , P65∼ = 0.001 ; and ≥18 years in Uyghurs , P prevalence of obesity was higher than Uyghur ’s ( general obesity : ≥35 years , P The prevalence of obesity increased after 18 years old and subsequently decreased after 55 years old . Meat consumption , older age , and female gender had a higher risk of obesity in these two minorities . Conclusions Both general and abdominal obesity were common in rural ethnic Kazakhs and Uyghurs . The prevalence rates were different in these two minorities depending on ethnicity , gender , and age . Kazakhs , females and elderly people may be prioritized in prevention of obesity in western China . Because of cost-effectiveness in measuring BMI and WC , we recommend that BMI and WC be integrated into local preventive policies in public health toward screening obesity and related diseases in low-income rural minorities",
"Introduction : The role of inflammatory cytokines in diabetes and its complications has been shown in some studies . The purpose of this study was to compare the effect of probiotic and conventional yogurt on inflammatory markers in patients with type 2 diabetes . Methods : Forty-four patients with type 2 diabetes were participated in this r and omized , double-blind controlled clinical trial and assigned to two intervention and control groups . The subjects in the intervention group consumed 300 g/d probiotic yogurt and subjects in the control group consumed 300 g/d conventional yogurt for 8 weeks . Anthropometric indices , dietary intakes , and serum levels of glucose , HbA1c , IL-6 , TNF-α and hs-CRP were evaluated at the beginning and end of the intervention . Results : For anthropometric indices and dietary intakes , no significant differences were seen within and between groups post intervention ( p > 0.05 ) . The consumption of probiotic yogurt caused significant decrease in HbA1c and TNF-α levels ( p= 0.032 and p= 0.040 , respectively ) in the intervention group . Conclusion : It is suggested that probiotic yogurt may be used as an alternative prevention approach and treatment method to control diabetic complications ",
"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",
"Background The prevalence of back pain is constantly increasing and a public health problem of high priority . In Austria there is a lack of empirical evidence for the development of back pain and its related factors . The present study aims to investigate trends in the prevalence of back pain across different sub population s ( sex , age , obesity ) . Methods A secondary data analysis based on five nationally representative cross-sectional health surveys ( 1973–2007 ) was carried out . Face-to-face interviews were conducted in private homes in Austria . Subjects aged 20 years and older were included in the study sample ( n = 178,818 ) . Obesity was defined as BMI ≥30 kg/m2 and adjusted for self-report bias . Back pain was measured as the self-reported presence of the disorder . Results The age-st and ardized prevalence of back pain was 32.9 % in 2007 ; it was higher among women than men ( p the prevalence of back pain was + 19.4 % . Among all sub population s the prevalence steadily increased . Obese men showed the highest increase of and the greatest risk for back pain . Conclusion These results help to underst and the development of back pain in Austria and can be used to plan controlled promotion programs . Further monitoring is recommended in order to control risk groups and plan target group-specific prevention strategies . In Austria particular emphasis should be on obese individuals . We recommend conducting prospect i ve studies to confirm our results and investigate causal relationships",
"Probiotic organisms have shown promise in treating diseases . Previously , we have reported on the efficacy of microencapsulated Lactobacillus reuteri NCIMB 30242 in a yogurt formulation at lowering serum cholesterol levels in otherwise healthy hypercholesterolemic adults . This study investigates the safety and toxicology of oral ingestion of microencapsulated L. reuteri NCIMB 30242 in a yogurt formulation . A r and omized group of 120 subjects received a dose of 5 × 10(10 ) CFU microencapsulated L. reuteri NCIMB 30242 in yogurt ( n=59 ) or placebo yogurt ( n=61 ) twice/day for 6 weeks . Clinical chemistry and hematological parameters of safety were analyzed . Fecal sample s were collected at these time points for the analysis of deconjugated bile acids . The frequency , duration and intensity of adverse events ( AEs ) and clinical significance of safety parameters were recorded for both groups . No clinical ly significant differences between the probiotic yogurt and placebo yogurt treated groups were detected in either the blood clinical chemistry or hematology results and there was no significant increase in fecal deconjugated bile acids ( P>0.05 ) between treated and control groups . The frequency and intensity of AEs was similar in the two groups . These results demonstrate the safe use of this formulation in food",
"OBJECTIVE To investigate the effects of probiotics on blood glucose levels and clinical outcomes in patients suffering from severe craniocerebral trauma . METHODS A prospect i ve r and omized control study was conducted . Fifty-two severe craniocerebral trauma patients admitted to intensive care unit ( ICU ) were r and omized into experimental or control group ( each n=26 ) . All patients received conventional treatment according to Guidelines for the Clinical Management of Traumatic Brain Injury and enteral nutrition within 24 - 48 hours after admission through nasogastric tube . In addition , the experimental group received 1 × 10(9 ) bacteria of viable probiotics ( Golden Bifid , 3.5 g for 3 times per day ) per day for 21 days . The fasting blood glucose levels were determined in the morning before intervention and on day 4 , 8 , 15 , 21 after intervention . Amount of insulin used during hospitalization , Glasgow coma scale ( GCS ) scores , length of ICU stay , and 28-day mortality rate were studied . RESULTS There was no difference in term of the blood glucose levels between two groups before intervention . On day 8 and 15 after intervention , significantly lower levels of fasting blood glucose were observed in the experimental group compared with those of the control group ( 8 days : 6.6±1.2 mmol/L vs. 8.0±2.7 mmol/L , t=-2.500 , P=0.017 ; 15 days : 6.1±1.4 mmol/L vs. 7.2±2.2 mmol/L , t=-2.269 , P=0.028 ) . There were significantly less patients treated with insulin or shorter days of insulin therapy in experimental group than in control group [ 19.2 % ( 5/26 ) vs. 46.2 % ( 12/26 ) , χ(2)=4.282 , P=0.039 ; 1.6±0.9 vs. 4.3±3.1 , t=-2.698 , P=0.017 ] . The length of ICU stay was significantly shorter in the experimental group than that of control group ( 6.8±3.8 days vs. 10.7±7.3 days , t=-2.123 , P=0.034 ) . No significant differences were found about the GCS scores ( before intervention : 6.3±1.0 vs. 6.4±1.0 , t=-0.408 , P=0.685 ; 21 days after intervention : 10.1±4.0 vs. 9.6±4.3 , t=0.435 , P=0.665 ) and 28-day mortality rate [ 11.5 % ( 3/26 ) vs. 19.2 % ( 5/26 ) , χ(2)=0.148 , P=0.701 ] between experimental group and control group . CONCLUSIONS Probiotics could facilitate blood glucose control in patients with severe craniocerebral injury . The underlying mechanisms and its long-term efficacy in this category of patients , however , need to be further investigated",
"Objective : To investigate the effect of a probiotic milk product containing the culture CAUSIDO ® and of two alternative products on risk factors for cardiovascular disease in overweight and obese subjects . Design : An 8 week r and omized , double-blind , placebo- and compliance-controlled , parallel study .Subjects : Seventy healthy , weight-stable , overweight and obese ( 25.0 , were r and omly assigned into five groups . Intervention : Four groups consumed 450 ml fermented milk products ( yoghurt ) daily . Group 1 : a yoghurt fermented with two strains of Streptococcus thermophilus and two strains of Lactobacillus acidophilus ( StLa ) . Group 2 : a placebo yoghurt fermented with delta-acid-lactone ( PY ) . Group 3 : a yoghurt fermented with two strains of Streptococcus thermophilus and one strain of Lactobacillus rhamnosus ( StLr ) . Group 4 : a yoghurt fermented with one strain of Enterococcus faecium and two strains of Streptococcus thermophilus ( CAUSIDO ® culture ) , GAIO ® ( G ) . The dietary composition of the yoghurt was otherwise similar . The fifth group was given two placebo pills ( PP ) daily . Results : When comparing all five treatment groups , unadjusted for changes in body weight , no statistical effects were observed in week 8 in the G-group on low density lipoproteins (LDL)-cholesterol ( P=0.29 ) . After adjustment for small changes in body weight , LDL-cholesterol decreased by 8.4 % ( 0.26±0.10 mmol/l ; P weeks , systolic blood pressure was significantly more reduced in the StLa and G-group compared to StLr . No other differences were found . Conclusion : The CAUSIDO ® culture reduced LDL-cholesterol and increased fibrinogen in the overweight subjects at a 450 ml consumption daily for 8 weeks . The effect on LDL-cholesterol confirms previous studies . An immunostimulation by one of the strains in the product might explain the effect on fibrinogen in the G-group . Sponsorship : MD Foods A/S , Denmark . European Journal of Clinical Nutrition ( 2000 ) 54 ,",
"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",
"This r and omized , placebo-controlled , double blind , parallel dose-response study investigated the impact of 4-week commercial yoghurt consumption supplemented with Bifidobacterium animalis subsp . lactis ( BB-12 ) and Lactobacillus acidophilus ( LA-5 ) on fecal bacterial counts of healthy adults . Fifty-eight volunteers were r and omly assigned to three different groups : 1 . placebo ( no probiotic , no starter and no green tea extract ) ; 2 . Yoptimal ( 10(9)cfu/100 g of BB-12 and LA-5 and 40 mg of green tea extract ) and 3 . Yoptimal-10 ( 10(10)cfu/100 g of BB-12 , 10(9)cfu/100 g of LA-5 and 40 mg of green tea extract ) . These yoghurt products also contained Lactobacillus delbrueckii subsp . bulgaricus ( 10(7)cfu/100 g ) and Streptococcus thermophilus ( 10(10)cfu/100 g ) . The quantitative PCR ( qPCR ) results showed that there were significant increases ( P=0.02 ) in bifidobacteria counts with the Yoptimal treatment as compared to baseline . The fecal numbers of B. animalis subsp . lactis and LA-5 significantly increased in the two probiotic treatments compared to the placebo treatment . Viable counts of fecal lactobacilli were significantly higher ( P=0.05 ) and those of enterococci were significantly lower ( P=0.04 ) after the intervention when compared to placebo . No significant difference was observed between treatments in volunteers ' weight , waist girth , blood pressure , fasting plasma triglyceride and HDL-C concentrations , as well as cholesterol/HDL-cholesterol ratio . However , a significant increase in plasma cholesterol levels was observed in the placebo group ( P=0.0018 ) but the levels remained stable in the two probiotic yoghurt groups . These results show that probiotic strains supplemented in the form of yoghurt remain active during gut transit and are associated with an increase in beneficial bacteria and a reduction in potentially pathogenic bacteria . This trial was registered at clinical trials.gov as NCT00730626",
"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",
"Urogenital infections afflict an estimated one billion people each year . The size of this problem and the increased prevalence of multi-drug resistant pathogens make it imperative that alternative remedies be found . A r and omized , placebo-controlled trial of 64 healthy women given daily oral capsules of Lactobacillus rhamnosus GR-1 and Lactobacillus fermentum RC-14 for 60 days showed no adverse effects . Microscopy analysis showed restoration from asymptomatic bacterial vaginosis microflora to a normal lactobacilli colonized microflora in 37 % women during lactobacilli treatment compared to 13 % on placebo ( P=0.02 ) . Lactobacilli were detected in more women in the lactobacilli-treated group than in the placebo group at 28 day ( P=0.08 ) and 60 day ( P=0.05 ) test points . Culture findings confirmed a significant increase in vaginal lactobacilli at day 28 and 60 , a significant depletion in yeast at day 28 and a significant reduction in coliforms at day 28 , 60 and 90 for lactobacilli-treated subjects versus controls . The combination of probiotic L. rhamnosus GR-1 and L. fermentum RC-14 is not only safe for daily use in healthy women , but it can reduce colonization of the vagina by potential pathogenic bacteria and yeast",
"Objective : To confirm the results of an earlier study showing premenopausal equol excretors to have hormone profiles associated with reduced breast cancer risk , and to investigate whether equol excretion status and plasma hormone concentrations can be influenced by consumption of probiotics . Design : A r and omized , single-blinded , placebo-controlled , parallel-arm trial . Subjects : In all , 34 of the initially enrolled 37 subjects completed all requirements . Intervention : All subjects were followed for two full menstrual cycles and the first seven days of a third cycle . During menstrual cycle 1 , plasma concentrations of estradiol ( E2 ) , estrone ( E1 ) , estrone-sulfate ( E1-S ) , testosterone ( T ) , and rostenedione ( A ) , dehydroepi and rosterone-sulfate ( DHEA-S ) , and sex-hormone-binding globulin ( SHBG ) were measured on cycle day 2 , 3 , or 4 , and urinary equol measured on day 7 after a 4-day soy challenge . Subjects then received either probiotic capsules ( containing Lactobacillus acidophilus and Bifidobacterium longum ) or placebo capsules through day 7 of menstrual cycle 3 , at which time both the plasma hormone concentrations and the post-soy challenge urinary equol measurements were repeated . Results : During menstrual cycle 1 , equol excretors and non-excretors were not significantly different with respect to subject characteristics , diet , or hormone concentrations . Significant inverse correlations were found between E2 and body mass index ( BMI ) ( P=0.02 ) , SHBG and BMI ( P=0.01 ) , DHEA-S and dietary fiber ( P=0.04 ) , and A and protein : carbohydrate ratio ( P=0.02 ) . Probiotic consumption failed to significantly alter equol excretor status or hormone concentrations during menstrual cycle 3 , although there were trends towards decreased concentrations of T ( P=0.14 ) and SHBG ( P=0.10 ) in the probiotic group . Conclusions : We were unable to verify a previously reported finding of premenopausal equol excretors having plasma hormone concentrations different from those of nonexcretors . Furthermore , a 2-month intervention with probiotic capsules did not significantly alter equol excretion or plasma hormone concentrations",
"Probiotics are believed to have interaction with immune cells through sustained effects on gene expression of different cytokines and transcription factors . The present r and omized doubled-blind controlled clinical trial was performed recruiting 75 individuals with BMI 25 - 35 , who were r and omly assigned to the following three groups : Group 1 ( n = 25 ) who consumed regular yogurt as part of a low calorie diet [ RLCD ] , group 2 ( n = 25 ) who received probiotic yogurt with a LCD [ PLCD ] and group 3 ( n = 25 ) who consumed probiotic yogurt without LCD [ PWLCD ] for 8 week . Participants in PLCD and PWLCD groups received 200 g/day yogurt containing Lactobacillus acidophilus La5 , Bifidobacterium Bb12 , and lactobacillus casei DN001 10(8 ) cfu/gr . The expression of the FOXP3 , T-bet , GATA3 , TNF-α , IFN-γ , TGF-β , and ROR-γt in P BMC s genes were assessed , before and after intervention . In three groups , ROR-γt expression was reduced ( P = 0.007 ) and FOXP3 was increased ( P The expression of TNFα , TGFβ , and GATA3 genes did not change among all groups after intervention . Interestingly , the expression of T-bet gene , which was significantly decreased in PLCD and PWLCD groups ( P whereas gene expression of IFN-γ decreased in all three groups . Our results suggest that weight loss diet and probiotic yogurt had synergistic effects on T-cell subset specific gene expression in peripheral blood mononuclear cells among overweight and obese individuals",
"Consumption of fermented milk ( FM ) containing a probiotic , Lactobacillus gasseri SBT2055 ( LG2055 ) , previously showed a reduction in abdominal adiposity in a r and omised controlled trial ( RCT ) using FM with 10(8 ) colony-forming units ( cfu ) of LG2055/g . However , whether the effectiveness is observed at lower concentrations , the recommended minimum or intermediate levels of probiotics ( 10(6 ) or 10(7 ) cfu/g , respectively ) , remains to be examined . A multi-centre , double-blind , parallel-group RCT was conducted using 210 healthy Japanese adults with large visceral fat areas ( 80·2 - 187·8 cm(2 ) ) . They were balanced for their baseline characteristics and r and omly assigned to three groups receiving FM containing 10(7 ) , 10(6 ) or 0 ( control ) cfu LG2055/g of FM , and were asked to consume 200 g FM/d for 12 weeks . Abdominal visceral fat areas , which were determined by computed tomography , at week 12 , changed from baseline by an average of -8·5 % ( 95 % CI -11·9 , -5·1 ; P measures including BMI , waist and hip circumferences , and body fat mass were also significantly decreased from baseline at week 12 in both groups ; interestingly , the cessation of taking FM for 4 weeks attenuated these effects . In the control group , none of these parameters significantly decreased from baseline . These findings demonstrate that consumption of LG2055 at doses as low as the order of 10(8 ) cfu/d exhibited a significant lowering effect on abdominal adiposity , and suggest that constant consumption might be needed to maintain the effect"
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41172760-06ff-11f0-808a-c43d1ab1c353
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Background Patient-specific cutting blocks have been touted as a more efficient and reliable means of achieving neutral mechanical alignment during TKA with the proposed downstream effect of improved clinical outcomes . However , it is not clear to what degree published studies support these assumptions . Questions / purpose sWe asked : ( 1 ) Do patient-specific cutting blocks achieve neutral mechanical alignment more reliably during TKA when compared with conventional methods ? ( 2 ) Does patient-specific instrumentation ( PSI ) provide financial benefit through improved surgical efficiency ? ( 3 ) Does the use of patient-specific cutting blocks translate to improved clinical results after TKA when compared with conventional instrumentation ? Methods We performed a systematic review in accordance with Cochrane guidelines of controlled studies ( prospect i ve and retrospective ) in MEDLINE ® and EMBASE ® with respect to patient-specific cutting blocks and their effect on alignment , cost , operative time , clinical outcome scores , complications , and survivorship . Sixteen studies ( Level I – III on the levels of evidence rubric ) were identified and used in addressing the first question , 13 ( Level I – III ) for the second question , and two ( Level III ) for the third question . Qualitative assessment of the selected Level I studies was performed using the modified Jadad score ; Level II and III studies were rated based on the Newcastle-Ottawa scoring system . Results The majority of studies did not show an improvement in overall limb alignment when PSI was compared with st and ard instrumentation . Mixed results were seen across studies with regard to the prevalence of alignment outliers when PSI was compared with conventional cutting blocks with some studies demonstrating no difference , some showing an improvement with PSI , and a single study showing worse results with PSI . The studies demonstrated mixed results regarding the influence of PSI on operative times . Decreased operative times were not uniformly observed , and when noted , they were found to be of minimal clinical or financial significance . PSI did reliably reduce the number of instrument trays required for processing perioperatively . The accuracy of the preoperative plan , generated by the PSI manufacturers , was found lacking , often leading to multiple intraoperative changes , thereby disrupting the flow of the operation and negatively impacting efficiency . Limited data exist with regard to the effect of PSI on postoperative function , improvement in pain , and patient satisfaction . Neither of the two studies we identified provided strong evidence to support an advantage favoring the use of PSI . No identified studies addressed survivorship of components placed with PSI compared with those placed with st and ard instrumentation . Conclusions PSI for TKA has not reliably demonstrated improvement of postoperative limb or component alignment when compared with st and ard instrumentation . Although decisive evidence exists to support that PSI requires fewer surgical trays , PSI has not clearly been shown to improve overall surgical efficiency or the cost-effectiveness of TKA . Mid- and long-term data regarding PSI ’s effect on functional outcomes and component survivorship do not exist and short-term data are scarce . Limited available literature does not clearly support any improvement of postoperative pain , activity , function , or ROM when PSI is compared with traditional instrumentation
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[
"Purpose To compare the femoral and tibial components rotational alignment in total knee arthroplasty ( TKA ) performed either with conventional or with patient-specific instrumentation . Methods Forty-five patients underwent primary TKA and were prospect ively r and omized into two groups : 22 patients into the conventional instrumentation group ( group A ) and 23 patients into the Signature ™ patient-specific instrumentation group ( group B ) . All patients underwent computed tomography of the operated knee in the first week after surgery to measure the components rotation . Results The femoral component rotation was 0.0 ° ( −0.25 , 1.0 ) in group A , and 0.0 ° ( 0.0 , 1.0 ) in group B. The tibial component rotation was −16.0 ° ( −18.5 , 11.8 ) in group A , and −16.0 ° ( −19.0 , −14.0 ) in group B. There were no significant differences between the two groups in tibial and femoral components rotation . The difference between the tibial component rotation and the neutral tibial rotation was similar in both groups [ 2.0 ° ( −0.5 , 6.3 ) in group A and 2.0 ° ( −1.0 , 4.0 ) in group B ] , but the dispersion around the median was different between the two groups . The amplitude of the difference between tibial rotation and neutral position was 27 ° ( −13 , 14 ) in group A and 9 ° ( −3 , 6 ) in group B. Conclusions There is a smaller chance of internal malrotation of the tibial component with the Signature ™ patient-specific instrumentation system , with less dispersion and amplitude of the tibial component rotation around the neutral position . Level of evidence II",
"Abstract Purpose It was our hypothesis that patient-specific instrumentation ( PSI ) can improve the accuracy of the rotational alignment in TKA based on the concept of the system and on the potential to clearly identify pre-operatively during planning the classical anatomical l and marks that serve as references to set-up the rotation both for the femur and tibia . Material s and methods In this prospect i ve comparative r and omized study , 40 patients ( 20 in each group ) operated in our institution between September 2012 and January 2013 by the 2 senior authors were included . R and omization of patients into one of the two groups was done by the Hospital Informatics Department with the use of a systematic sampling method . All patients received the same cemented high-flex mobile bearing TKA . In the PSI group , implant position was compared to the planed position using previously vali date d dedicated software . The position of the implants ( frontal and sagittal ) was compared in the 2 groups on st and ard X-rays , and the rotational position was analysed on post-operative CT-scan . Results 90 % of the patients add tibial rotation where the variations were much higher . Mean HKA was 179 ° ( 171–185 ) in the PSI group with 4 outliers ( 2 varus : 171 ° and 172 ° :184 ° and 185 ° ) and 178.3 ° with 2 outliers ( 171 ° and 176 ° ) in the control group . No difference was observed between the two groups concerning the frontal and sagittal position of the implants on the ML and AP X-rays . No significant difference of femoral rotation was observed between the two groups with a mean of 0.4 ° in the PSI group and 0.2 ° in the control group ( p : n.s ) . Mean tibial rotation was 8 ° of internal rotation in the PSI group and 15 ° of internal rotation in the st and ard group ( p : n.s ) . Conclusion Based on our results , we were unable to confirm our hypothesis as PSI can not improve rotation in TKA . More work needs to be done to more clearly define the place of PSI in TKA , to keep on improving the accuracy of the system and to better define the individual targets in TKA in terms of frontal , sagittal and rotational positioning of the implant for each patient . Level of evidence Prospect i ve comparative r and omized study , Level II",
"Background Patient-specific instrumentation potentially improves surgical precision and decreases operative time in total knee arthroplasty ( TKA ) but there is little supporting data to confirm this presumption . Questions / purpose sWe asked whether patient-specific instrumentation would require infrequent intraoperative changes to replicate a single surgeon ’s preferences during TKA and whether patient-specific instrumentation guides would fit securely . Methods We prospect ively evaluated the plan and surgery in 60 patients treated with 66 TKAs performed with patient-specific instrumentation and recorded any changes . A subset of six postoperative radiographic changes to the femoral and tibial components ( implant size , coronal and sagittal alignment ) was analyzed to determine if surgeon intervention was beneficial . Each guide was evaluated to determine fit . We compared patient demographics and implant sizing in the patient-specific instrumentation group with a control group in which traditional instrumentation was used . Results We recorded 161 intraoperative changes in 66 knee arthroplasties ( 2.4 changes/knee ) performed with patient-specific instrumentation . The predetermined implant size was changed intraoperatively in 77 % of femurs and 53 % of tibias . We identified a subset of 95 intraoperative changes that could be radiographically evaluated to determine if our changes were an improvement or detriment to reaching goal alignment . Eighty-two of the 95 changes ( 86 % ) made by the surgeon were an improvement to the recommended alignment or size of patient-specific instrumentation . The guide did not fit securely on eight femurs ( 12 % ) and three tibias ( 5 % ) . Tourniquet time and blood loss were not improved with patient-specific instrumentation . Conclusions We caution surgeons against blind acceptance of patient-specific instrumentation technology without supportive data .Level of Evidence Level III , therapeutic study . See Guidelines for Authors for a complete description of levels of evidence",
"Abstract Purpose The introduction of patient-specific instruments ( PSI ) for guiding bone cuts could increase the incidence of malalignment in primary total knee arthroplasty . The purpose of this study was to assess the agreement between one type of patient-specific instrumentation ( Zimmer PSI ) and the pre-operative plan with respect to bone cuts and component alignment during TKR using imageless computer navigation . Methods A consecutive series of 30 femoral and tibial guides were assessed in-theatre by the same surgeon using computer navigation . Following surgical exposure , the PSI cutting guides were placed on the joint surface and alignment assessed using the navigation tracker . The difference between in-theatre data and the pre-operative plan was recorded and analysed . Results The error between in-theatre measurements and pre-operative plan for the femoral and tibial components exceeded 3 ° for 3 and 17 % of the sample , respectively , while the error for total coronal alignment exceeded 3 ° for 27 % of the sample . Conclusion The present results indicate that alignment with Zimmer PSI cutting blocks , assessed by imageless navigation , does not match the pre-operative plan in a proportion of cases . To prevent unnecessary increases in the incidence of malalignment in primary TKR , it is recommended that these devices should not be used without objective verification of alignment , either in real-time or with post-operative imaging . Further work is required to identify the source of discrepancies and vali date these devices prior to routine use . Level of evidence II",
"The primary purpose of this prospect i ve , r and omized study was to determine if patient-specific instrumentation ( PSI ) for total knee arthroplasty ( TKA ) shortened surgical time . Secondarily the number of instrument trays and alignment were also compared to cases performed with traditional instrumentation ( TI ) . Fifty-two cases ( 26 per group ) were r and omized and videotaped to measure the length of surgery , as well as each individual surgical step . Component alignment and mechanical axis was measured radiographically for each patient . Total surgical time was over 4 minutes shorter for patients in the TI group ( 57.4 minutes vs. 61.8 minutes ; P instrument trays were used in the TI group ( 7.3 vs. 2.5 ; P difference in mechanical alignment between groups on postoperative long alignment radiographs ( P=0.77 ) . In conclusion , PSI did not shorten surgical time or improve alignment compared with TI in this prospect i ve , r and omized trial , but did reduce the required number of trays",
"Magnetic resonance imaging ( MRI ) or computed tomography-based patient-specific instrumentation ( PSI ) may allow for reliable alignment and fewer outliers when compared with conventionally instrumented total knee arthroplasty ( TKA ) . However , some authors have suggested that frequent intraoperative surgeon-directed changes may still be required . This study evaluated the accuracy of PSI to predict component sizing and alignment during TKA . A total of 84 patients ( 89 knees ) who underwent a TKA using a PSI system were evaluated . An MRI-based preoperative plan of every knee was provided and approved by the surgeons . This demonstrated the proposed prosthetic component alignment , as well as the femoral , tibial , and bearing insert component size and position . Intraoperative changes to these components were prospect ively recorded and compared with the computerized preoperative plan . Major changes were defined as any changes in femoral or tibial resection , size , and position of the components . Minor changes were defined as any change in the size of the polyethylene bearing insert . The preoperative plan was able to correctly predict the size of the implanted tibial and femoral component in 93 and 95.5 % of the cases , respectively . Thirteen major intraoperative changes were made . In one knee , the proposed femoral resection was not acceptable ( because of the presence of significant amount of osteophytes ) and was ab and oned in favor of a manual extramedullary guide . In another patient , the proposed femoral and tibial components were upsized . In two other patients , the femoral components were downsized , in four patients , the tibial components were downsized , and in another patient , it was upsized . There were also 16 minor changes , which included 2-mm upsizing of the polyethylene liner in 13 knees and 4-mm upsizing in 3 knees . Surgical experience is necessary to recognize improper component size , incorrect surgical resection , or nonideal alignment when performing TKA using PSI . The authors believe that the design and manufacture of PSI combined with a comprehensive templating result ed in excellent intraoperative concordance of the preoperative plan at the default setting s with minimal changes",
"Abstract Purpose The aim of this study was to investigate the post-operative radiological outcomes of patient-specific instrumentation ( PSI ) surgery versus conventional total knee arthroplasty ( TKA ) . Methods Sixty patients scheduled for a primary TKA were prospect ively divided into PSI or conventional technique . Coronal and sagittal radiographic long limb films were taken post-operatively . The accepted values for normal alignment were 180 ° ± 3 ° for hip-knee-ankle angle ; 90 ° ± 3 ° for coronal femoral component angle or coronal tibia component angle ; 0 ° to 3 ° flexion for sagittal femoral component angle and 0 ° to 7 ° posterior slope for sagittal tibia component angle . Results For hip-knee-ankle angle , there were 21 % more outliers in the PSI group compared to the conventional group ( p = 0.045 ) . Most of these outliers had valgus deformity in the PSI group and varus deformity in the conventional group ( p = 0.045 ) . For implant placement , there was no difference in the proportion of outliers between the two groups . There was also no difference in the duration of surgery . Conclusions This study showed that PSI surgery is associated with a larger proportion of outliers for lower limb alignment . PSI surgery as an alternative to conventional TKA is not advisable . Level of evidence II",
"Purpose The aim of this study is to evaluate the accuracy of a patient-specific instrumentation ( PSI ) as assessed by the intraoperative use of knee navigation software during the surgical procedure . Methods Fifteen patients with primary gonarthrosis were selected for unilateral total knee arthroplasty . The first three patients were excluded from this study , as they were considered to be a warm up to set-up the procedure . All patients were operated on with a cemented posterior-stabilised prosthesis cruciate ligament-sacrificing by the same surgeon using the patient matched cutting jigs . The size of the implant , level of resection , and alignment in the coronal and sagittal planes were evaluated . An unsatisfactory result was considered an error ≥2 ° in both planes for each component as a possible error of 4 ° could result in aggravation . Results On the coronal plane the mean deviation of the tibial guide from the ideal alignment was 1.2 ± 1.5 ( range 0–5 ° ) and in the sagittal plane was 3.8 ± 2.4 ( range 0–7.5 ° ) . On the coronal plane the mean deviation of the femoral guide from the ideal alignment was 1.2 ± 0.6 and in the sagittal was 3.7 ± 2 . Conclusion On the basis of this preliminary experience the PSI system based only on data acquisition with A-P radiograms and RMN can not be defined as accurate . In cases of the use of the custom made cutting jigs it is recommended to perform an accurate control of the alignment before making the cuts , for any step of the procedure . Level of evidence II",
"The purpose of the current prospect i ve , r and omized study was to compare the value of a new mechanically aligned patient-matched instrument system for total knee arthroplasty ( TKA ) ( Visionaire ; Smith & Nephew , Inc , Memphis , Tenn ) ( VIS ) to that of st and ard TKA surgical instrumentation ( STD ) . Twenty-nine primary TKA patients were enrolled and completed surgery ( 15 VIS and 14 STD ) . Postoperatively , mechanical alignment was significantly closer to neutral zero in the VIS group ( 1.7 ° vs 2.8 ° ; P = .03 ) . Furthermore , the VIS group demonstrated significant reductions in duration of hospital stay , operative time , incision length , and number of used instrument trays ( P < .05 ) . Although additional research is underway to confirm these preliminary results , this evidence suggests that patient-matched instrumentation may support repeatable improvements in surgical accuracy and hospital efficiency",
"Abstract Purpose The purpose of the study was to evaluate the accuracy of the planning of the patient-specific pin guides in total knee arthroplasty ( TKA ) . This planning was performed primarily by a technician of the company and offered to the surgeon . All parameters of the implantation can either be modified or accepted by the surgeon . The hypothesis was that the plan needs preoperative intervention by the surgeon . Methods A prospect i ve study in 50 patients was carried out . All patients received the same posterior-stabilised implant with patient-specific instrumentation . All surgical parameters ( coronal , sagittal , rotational alignment , femoral and tibial resection levels and implant sizes ) were checked by the orthopaedic surgeon and changed if necessary . Results Preoperatively , the femoral size was changed in 8 patients ( 16 % ) , the femoral flexion in 23 patients ( 46 % ) , the femoral shift in 34 patients ( 68 % ) , the tibial size in 24 patients ( 48 % ) and the tibial rotation in all patients . The epicondylar axis was accepted in 47 patients ( 94 % ) in the technician plan . Mean planning time was 8 ± 4 min . Intraoperatively , the femoral anterior – posterior size was in 50 patients ( 100 % ) the same as in the surgeon and in 42 patients ( 84 % ) the same as in the technician plan ( p = 0.003 ) . The tibial component implanted was in 42 patients ( 84 % ) the same as in the surgeon and in 19 patients ( 38 % ) the same as in the technician plan ( p A femoral distal recut was necessary in 31 patients ( 62 % ) and a change of the tibial proximal cut in 17 patients ( 34 % ) during surgery . Intraoperatively , no changes of the femoral and tibial alignment , the femoral anterior – posterior size , the femoral flexion , the femoral shift , the femoral and tibial rotation were necessary . Postoperatively , the coronal mechanical overall axis was within ±3 ° in 47 patients ( 94 % ) with a maximum deviation of 5.6 ° . Conclusions Significant changes of the technician plan were necessary to get an accurate preoperative plan . Intraoperative changes were significant less compared to the surgeon than to the technician plan . No major changes ( alignment , femoral anterior – posterior size and rotation ) of the surgeon plan were necessary . Surgeons using patient-specific pin guides in TKA may verify the default plan provided by the technician . A blind reply on the technician plan may be not recommended . Level of evidence Therapeutic study , Level III",
"Patient specific cutting guides generated by preoperative Magnetic Resonance Imaging ( MRI ) of the patient 's extremity have been proposed as a method of improving the consistency of Total Knee Arthroplasty ( TKA ) alignment and adding efficiency to the operative procedure . The cost of this option was evaluated by quantifying the savings from decreased operative time and instrument processing costs compared to the additional cost of the MRI and the guide . Coronal plane alignment was measured in an unselected consecutive series of 200 TKAs , 100 with st and ard instrumentation and 100 with custom cutting guides . While the cutting guides had significantly lower total operative time and instrument processing time , the estimated $ 322 savings was overwhelmed by the $ 1,500 additional cost of the MRI and the cutting guide . All measures of coronal plane alignment were equivalent between the two groups . The data does not currently support the proposition that patient specific guides add value to TKA",
"Patient-specific cutting guides ( PSCGs ) are design ed to improve the accuracy of alignment of total knee replacement ( TKR ) . We compared the accuracy of limb alignment and component positioning after TKR performed using PSCGs or conventional instrumentation . A total of 80 patients were r and omised to undergo TKR with either of the different forms of instrumentation , and radiological outcomes and peri-operative factors such as operating time were assessed . No significant difference was observed between the groups in terms of tibiofemoral angle or femoral component alignment . Although the tibial component in the PSCGs group was measurably closer to neutral alignment than in the conventional group , the size of the difference was very small ( 89.8 ° ( sd 1.2 ) vs 90.5 ° ( sd 1.6 ) ; p = 0.030 ) . This new technology slightly shortened the bone-cutting time by a mean of 3.6 minutes ( p and the operating time by a mean 5.1 minutes ( p = 0.019 ) , without tangible differences in post-operative blood loss ( p = 0.528 ) or need for blood transfusion ( p = 0.789 ) . This study demonstrated that both PSCGs and conventional instrumentation restore limb alignment and place the components with the similar accuracy . The minimal advantages of PSCGs in terms of consistency of alignment or operative time are unlikely to be clinical ly relevant"
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411727a6-06ff-11f0-808a-c43d1ab1c353
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Purpose This systematic review was performed to summarize published experience using low density lipoprotein particle number ( LDL-P ) to monitor the efficacy of lipid-lowering pharmacotherapies . Methods Studies were identified from a literature search of MEDLINE ( January 1 , 2000 – June 30 , 2012 ) ; and abstract search es of select conferences . All accepted studies reported mean ( or median ) nuclear magnetic resonance (NMR)-based LDL-P values for at least 10 subjects receiving lipid lowering pharmacotherapy . Results Search es revealed 36 studies ( with 61 treatment arms ) in which LDL-P measurements were reported pre- and post-treatment . Most studies also reported changes in low-density lipoprotein cholesterol ( LDL-C ) , but fewer studies reported changes in apolipoprotein B (apoB)(n = 20 ) and non-HDL-C ( n = 28 ) . Treatments included statins ( 22 arms/15 studies ) , fibrates ( 7 arms/7 studies ) , niacin ( 7 arms/6 studies ) , bile acid sequestrants ( 5 arms/2 studies ) , an anti-apoB oligonucleotide ( 2 arms/2 studies ) , combination therapies ( 8 arms/6 studies ) , anti-diabetics ( 5 arms/4 studies ) , and , other treatments ( 5 arms/2 studies ) . Lipid-lowering pharmacotherapy result ed in reductions in mean LDL-P in all but two studies . In several statin studies , the percent reductions in LDL-P were smaller than reductions in LDL-C , comparable changes were reported when LDL-P and apoB , were reported . Conclusions Study -level data from this systemic review establish that different lipid lowering agents can lead to discordance between LDL-P and LDL-C , therefore , basing LDL-lowering therapy only on the achievement of cholesterol goals may result in a treatment gap . Therefore , the use of LDL-P for monitoring lipid-lowering therapy , particularly for statins , can provide a more accurate assessment of residual cardiovascular risk
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[
"This double-blind , r and omized crossover study investigated the effects of 6 weeks of treatment with prescription omega-3-acid ethyl esters ( POM3 , 4 g/day ) versus placebo ( soy oil ) on low-density lipoprotein cholesterol ( LDL-C ) and other aspects of the fasting lipid profile in 31 men and women with primary , isolated hypercholesterolemia ( LDL-C 130 - 220 mg/dL and triglycerides less than 150 mg/dL while free of lipid-altering therapies ) . Mean ± st and ard error of the mean baseline concentrations of total cholesterol , LDL-C , high-density lipoprotein cholesterol ( HDL-C ) , very-low-density lipoprotein cholesterol , and triglycerides were 229 ± 3 , 146 ± 3 , 60 ± 2 , 23 ± 2 , and 113 ± 8 mg/dL , respectively . POM3 produced a modest increase from baseline in LDL-C ( 3.4 % ) versus the placebo response ( -0.7 % , P = 0.010 ) . Significant changes ( P ( placebo-corrected ) were observed for very-low-density lipoprotein cholesterol ( -18.8 % ) , triglycerides ( -18.7 % ) , and HDL-C ( 3.3 % ) . Nuclear magnetic resonance-determined very-low-density lipoprotein particle concentration and size and HDL particle concentration decreased significantly more with POM3 versus placebo , whereas LDL and HDL particle sizes increased significantly more with POM3 versus placebo . Total cholesterol , non-HDL-C , apolipoproteins A1 and B , and LDL particle concentration responses did not differ between treatments . These results did not confirm the hypothesis that POM3 treatment would lower LDL-C in primary , isolated hypercholesterolemia . Effects on other variables were consistent with prior results in mixed dyslipidemia",
"Background — Nuclear magnetic resonance ( NMR ) spectroscopy measures the number and size of lipoprotein particles instead of their cholesterol or triglyceride content , but its clinical utility is uncertain . Methods and Results — Baseline lipoproteins were measured by NMR in 27 673 initially healthy women followed up for incident cardiovascular disease ( n=1015 ) over an 11-year period . After adjustment for nonlipid risk factors , hazard ratios and 95 % confidence intervals for the top versus the bottom quintile of NMR-measured lipoprotein particle concentration ( measured in particles per liter ) were 2.51 ( 1.91 to 3.30 ) for low-density lipoprotein ( LDLNMR ) , 0.91 ( 0.75 to 1.12 ) for high-density lipoprotein ( HDLNMR ) , 1.71 ( 1.38 to 2.12 ) for very low – density lipoprotein ( VLDLNMR ) , and 2.25 ( 1.80 to 2.81 ) for the LDLNMR/HDLNMR ratio . Similarly adjusted results for NMR-measured lipoprotein particle size ( measured in nanometers ) were 0.64 ( 0.52 to 0.79 ) for LDLNMR size , 0.65 ( 0.51 to 0.81 ) for HDLNMR size , and 1.37 ( 1.10 to 1.70 ) for VLDLNMR size . Hazard ratios for NMR measures were comparable but not superior to st and ard lipids ( total cholesterol 2.08 [ 1.63 to 2.67 ] , LDL cholesterol 1.74 [ 1.40 to 2.16 ] , HDL cholesterol 0.52 [ 0.42 to 0.64 ] , triglycerides 2.58 [ 1.95 to 3.41 ] , non-HDL cholesterol 2.52 [ 1.95 to 3.25 ] , total/HDL cholesterol ratio 2.82 [ 2.23 to 3.58 ] ) and apolipoproteins ( B100 2.57 [ 1.98 to 3.33 ] , A-1 0.63 [ 0.52 to 0.77 ] , and B100/A-1 ratio 2.79 [ 2.21 to 3.54 ] ) . Essentially no reclassification improvement was found with the addition of the LDLNMR particle concentration or apolipoprotein B100 to a model that already included the total/HDL cholesterol ratio and nonlipid risk factors ( net reclassification index 0 % and 1.9 % , respectively ) , nor did the addition of either variable result in a statistically significant improvement in the c-index . Conclusions — In this prospect i ve study of healthy women , cardiovascular disease risk prediction associated with lipoprotein profiles evaluated by NMR was comparable but not superior to that of st and ard lipids or apolipoproteins",
"Background — Changes in conventional lipid risk factors with gemfibrozil treatment only partially explain the reductions in coronary heart disease ( CHD ) events experienced by men in the Veterans Affairs High-Density Lipoprotein Intervention Trial ( VA-HIT ) . We examined whether measurement of low-density lipoprotein ( LDL ) and high-density lipoprotein ( HDL ) particle subclasses provides additional information relative to CHD risk reduction . Methods and Results — This is a prospect i ve nested case-control study of 364 men with a new CHD event ( nonfatal myocardial infa rct ion or cardiac death ) during a 5.1-year ( median ) follow-up and 697 age-matched controls . Nuclear magnetic resonance ( NMR ) spectroscopy was used to quantify levels of LDL and HDL particle subclasses and mean particle sizes in plasma obtained at baseline and after 7 months of treatment with gemfibrozil or placebo . Odds ratios for a 1-SD increment of each lipoprotein variable were calculated with adjusted logistic regression models . Gemfibrozil treatment increased LDL size and lowered numbers of LDL particles ( −5 % ) while raising numbers of HDL particles ( 10 % ) and small HDL subclass particles ( 21 % ) . Concentrations of these LDL and HDL particles achieved with gemfibrozil were significant , independent predictors of new CHD events . For total LDL and HDL particles , odds ratios predicting CHD benefit were 1.28 ( 95 % CI , 1.12 to 1.47 ) and 0.71 ( 95 % CI , 0.61 to 0.81 ) , respectively . Mean LDL and HDL particle sizes were not associated with CHD events . Conclusions — The effects of gemfibrozil on NMR-measured LDL and HDL particle subclasses , which are not reflected by conventional lipoprotein cholesterol measures , help to explain the demonstrated benefit of this therapy in patients with low HDL cholesterol",
"BACKGROUND Icosapent ethyl ( IPE ; formerly AMR101 ) is a high-purity prescription form of eicosapentaenoic acid ethyl ester . In the MARINE study we evaluated the efficacy and safety of IPE in patients with very high triglycerides ( TG ; ≥500 mg/dL ) and previously demonstrated significant reductions in TG levels with no significant increases in low-density lipoprotein ( LDL ) cholesterol levels . OBJECTIVES In this follow-up , exploratory analysis , we report the effects of IPE on lipoprotein particle concentration and size . METHODS MARINE was a phase 3 , multicenter , placebo-controlled , r and omized , double-blind , 12-week study . Hypertriglyceridemic patients ( N = 229 ) were r and omized to three treatment groups : IPE 4 g/day , IPE 2 g/day , or placebo . Lipoprotein particle concentrations and sizes were measured by nuclear magnetic resonance spectroscopy . RESULTS Compared with placebo , IPE 4 g/day significantly reduced median concentrations of large very-low-density lipoprotein ( VLDL ; -27.9 % ; P = .0211 ) , total LDL ( -16.3 % ; P = .0006 ) , small LDL ( -25.6 % ; P and total high-density lipoprotein ( HDL ; -7.4 % ; P = .0063 ) particles and reduced VLDL particle size ( -8.6 % ; P = .0017 ) . In this patient population with TG ≥500 mg/dL , IPE did not significantly change the overall sizes of LDL or HDL particles . CONCLUSION IPE 4 g/day significantly reduced large VLDL , total LDL , small LDL , and total HDL particle concentrations and VLDL particle size in patients with TG ≥500 mg/dL. Changes in VLDL particle concentration and size reflect the TG-lowering effects of eicosapentaenoic acid . The reduction in LDL particle concentration with IPE is novel among ω-3 therapies and is consistent with the previously reported reduction in apolipoprotein B and lack of LDL-C increase with IPE in patients with very high TG levels . CLINICAL TRIAL REGISTRATION NUMBER NCT01047683",
"BACKGROUND To assess the lipid-lowering effects and safety of atorvastatin and niacin in patients with combined hyperlipidemia or isolated hypertriglyceridemia . METHODS We performed a r and omized , open-label , parallel- design , active-controlled , study in eight centers in the United States . We enrolled 108 patients with total cholesterol ( TC ) of > or = 200 mg/dL , serum triglycerides ( TG ) > or = 200 and or = 110 mg/dL. Patients were r and omly assigned to receive atorvastatin 10 mg once daily ( n=55 ) or immediate-release niacin 1 g three times daily for 12 weeks ( n=53 ) . Patients were stratified based on low-density lipoprotein cholesterol ( LDL-C ) : Patients with LDL-C > or = 135 mg/dL were considered to have combined hyperlipidemia and patients with LDL-C percent change from baseline in LDL-C. Other lipid levels were evaluated as secondary parameters . RESULTS Atorvastatin reduced LDL-C 30 % and TC 26 % from baseline , and increased high-density lipoprotein cholesterol ( HDL-C ) 4 % . Total TG were reduced 17 % . Niacin reduced LDL-C 2 % , TC 7 % , increased HDL-C 25 % , and reduced total TG 29 % from baseline . There was a significant difference in LDL-C reduction , the primary efficacy parameter , between the two treatment groups ( P HDL-C ( P tolerated than niacin . CONCLUSION Atorvastatin may allow patients with combined hyperlipidemia to be treated with monotherapy and offers an efficacious and well-tolerated alternative to niacin for the treatment of patients with isolated hypertriglyceridemia",
"Aims A r and omized , double-blind , placebo-controlled study was conducted to investigate the safety and efficacy of mipomersen , an apolipoprotein B-100 ( apoB ) synthesis inhibitor , in patients who are statin intolerant and at high risk for cardiovascular disease ( CVD ) . Methods and results Thirty-three subjects , not receiving statin therapy because of statin intolerance , received a weekly subcutaneous dose of 200 mg mipomersen or placebo ( 2:1 r and omization ) for 26 weeks . The primary endpoint was per cent change in LDL cholesterol ( LDL-c ) from the baseline to Week 28 . The other efficacy endpoints were per cent change in apoB and lipoprotein a [ Lp(a ) ] . Safety was determined using the incidence of treatment-emergent adverse events ( AEs ) and clinical laboratory evaluations . After 26 weeks of mipomersen administration , LDL-c was reduced by 47 ± 18 % ( P placebo ) . apoB and Lp(a ) were also significantly reduced by 46 and 27 % , respectively ( P Four mipomersen ( 19 % ) and two placebo subjects ( 17 % ) discontinued dosing prematurely due to AEs . Persistent liver transaminase increases ≥3 × the upper limit of normal were observed in seven ( 33 % ) subjects assigned to mipomersen . In selected subjects , liver fat content was assessed , during and after treatment , using magnetic resonance spectroscopy . Liver fat content in these patients ranged from 0.8 to 47.3 % . Liver needle biopsy was performed in two of these subjects , confirming hepatic steatosis with minimal inflammation or fibrosis . Conclusion The present data suggest that mipomersen is a potential therapeutic option in statin-intolerant patients at high risk for CVD . The long-term follow-up of liver safety is required . Clinical Trial Registration : Clinical Trials.gov identifier :",
"Lipoprotein subclass analyses may facilitate coronary heart disease ( CHD ) risk stratification and provide insight into the cardioprotective benefits of statins ( 3-hydroxymethylglutaryl-coenzyme A reductase inhibitors ) . This study evaluated the influence of pravastatin on lipoprotein subclass profiles to determine whether subjects with predominantly large LDL ( LDL size > 20.5 nm ) or small LDL ( LDL size differ in responsiveness to drug treatment . Frozen plasma specimens were analyzed from a subset of participants in the Pravastatin Limitation of Atherosclerosis in the Coronaries ( PLAC-I ) trial at baseline and after treatment for 6 months with pravastatin ( n=154 ) or placebo ( n=138 ) . Lipids were measured by st and ard chemical methods and lipoprotein subclasses by nuclear magnetic resonance ( NMR ) spectroscopy . Pravastatin-induced changes in lipid levels were similar in subjects with large or small LDL at baseline . Levels of the most abundant LDL subclass were preferentially lowered by pravastatin , result ing in an increase in average LDL size for those with a predominance of small LDL . High-risk CHD subjects with small LDL particles gain at least as much pharmacological benefit from pravastatin as those with large LDL , as evidence d by reductions in the numbers of total and small LDL particles , and increases in average LDL and HDL particle size",
"Background —Nuclear magnetic resonance ( NMR ) offers an alternative , spectroscopic means of quantifying LDL and of measuring LDL particle size . Methods and Results —We conducted a prospect i ve nested case-control study among healthy middle-aged women to assess LDL particle size ( NMR ) and concentration ( NMR ) as risk factors for future myocardial infa rct ion , stroke , or death of coronary heart disease . Median baseline levels of LDL particle concentration ( NMR ) were higher ( 1597 vs 1404 nmol/L;P = 0.0001 ) and LDL particle size ( NMR ) was lower ( 21.5 vs 21.8 nm;P = 0.046 ) among women who subsequently had cardiovascular events ( n=130 ) than among those who did not ( n= 130 ) . Of these 2 factors , LDL particle concentration ( NMR ) was the stronger predictor ( relative risk for the highest compared with the lowest quartile=4.17 , 95 % CI 1.96–8.87 ) . This compared with a relative risk of 3.11 ( 95 % CI 1.55–6.26 ) for the ratio of total cholesterol to HDL cholesterol and a relative risk of 5.91 ( 95 % CI 2.65–13.15 ) for C-reactive protein . The areas under the receiver operating characteristic curves for LDL particle concentration ( NMR ) , total cholesterol to HDL cholesterol ratio , and C-reactive protein were 0.64 , 0.64 , and 0.66 , respectively . LDL particle concentration ( NMR ) correlated with several traditionally assessed lipid and nonlipid risk factors , and thus adjustment for these tended to attenuate the magnitude of association between LDL particle concentration ( NMR ) and risk . Conclusions —In this cohort , LDL particle concentration measured by NMR spectroscopy was a predictor of future cardiovascular risk . However , the magnitude of predictive value of LDL particle concentration ( NMR ) was not substantively different from that of the total cholesterol to HDL cholesterol ratio and was less than that of C-reactive protein",
"Lipoprotein subclass measurements may enhance the prediction of coronary artery disease ( CAD ) risk , but clinical application of such information has been hindered by the relatively laborious and time-consuming nature of laboratory measurement methods . In this study , lipoprotein subclass analyses were performed on frozen plasma sample s from 241 participants in the Pravastatin Limitation of Atherosclerosis in the Coronary arteries Trial using an automated nuclear magnetic resonance technique . The objective was to determine if levels of these subclasses provided additional information on the progression of CAD , based on the change in the minimum lumen diameter , over a 3-year period . After adjustment for race , sex , age , treatment group , baseline lumen diameter , and chemically measured levels of triglycerides , low-density lipoprotein ( LDL ) cholesterol , and high-density lipoprotein ( HDL ) cholesterol , on-trial predictors ( p elevated LDL particle number , and levels of small LDL and small HDL . Within treatment groups , CAD progression was most strongly related to the LDL particle number ( placebo ) and levels of small HDL ( pravastatin ) . In logistic regression models that adjusted for chemically determined lipid levels and other covariates , a small LDL level > or = 30 mg/dl ( median ) was associated with a ninefold increased risk of CAD progression ( p < 0.01 ) in the placebo group . These results indicate that levels of various lipoprotein subclasses may provide useful information on CAD risk even if levels of traditional risk factors are known",
"BACKGROUND Although recommended as initial therapy for patients with dyslipidemia who are taking human immunodeficiency virus protease inhibitors ( HIV PIs ) , the effects of pravastatin on lipoproteins and arterial reactivity have not been eluci date d. The purpose of this study was to determine the effects of pravastatin on lipoprotein subfractions and endothelial function in patients with dyslipidemia who are receiving HIV PIs . METHODS This was a placebo-controlled , double-blind , crossover study comparing pravastatin ( 40 mg ) to placebo in 20 patients who were taking HIV PIs . Lipoprotein subfractions were measured with nuclear magnetic resonance spectroscopic analysis . Flow-mediated vasodilation ( FMD ) of the brachial artery was evaluated with high-resolution ultrasound scanning . RESULTS At baseline , subjects had an increased concentration of low-density lipoprotein ( LDL ) particles ( 1756 + /- 180 nmol/L ) , which tended to be small ( 19.9 + /- 0.2 nm ) , a low concentration of large high-density lipoproteins ( HDL ; 0.94 + /- 0.07 mmol/L ) , and an increased concentration of large very low-density lipoproteins ( VLDL ; 1.90 + /- 0.58 mmol/L ) . FMD was impaired ( 4.5 % + /- 1.1 % ) . Compared with placebo , pravastatin result ed in a 20.8 % reduction in LDL particles ( P = .030 ) , a 26.7 % reduction in small LDL ( P = .100 ) , and a 44.9 % reduction in small VLDL ( P = .023 ) . Total and non-HDL cholesterol levels decreased by 18.3 % ( P FMD tended to increase in patients receiving pravastatin ( 0.7 % + /- 0.6 % ) ; however , the difference between treatment phases was not statistically significant ( P = .080 ) . CONCLUSIONS This is the first double-blind , placebo-controlled study of the effects of statin therapy on lipids , lipoprotein subfractions , and endothelial function in patients taking HIV PIs . Pravastatin reduced concentrations of atherogenic lipoproteins , particularly those most associated with future coronary events",
"BACKGROUND Although LDL-cholesterol ( LDL-C ) remains the target of cholesterol-lowering therapy , high levels of LDL particle numbers better differentiate cardiovascular risk than LDL-C concentrations . Colesevelam HCl , a novel bile acid sequestrant , has also been shown to reduce mean LDL-C by 18 % with the maximum dose . The effect of colesevelam HCl on LDL particle number and particle size has not been previously published . LDL particle number and particle size were measured by NMR spectroscopy . METHODS In this multi-center , double-blind , placebo-controlled study , 149 patients with moderate hypercholesterolemia ( LDL-C > 160 mg/dL [ 4.14 mmol/L ] ; triglycerides were r and omized to colesevelam HCl ( 1.5 - 3.75 g/d ) or placebo for 6 weeks . RESULTS Colesevelam HCl reduced LDL particle number by 6.8 % at a dosage of 3.0 g/d ( P = 0.031 ) , and 13.7 % ( P = 0.0002 ) at a dosage of 3.75 g/d . Baseline levels of triglycerides or LDL size did not influence changes in LDL particle number . Further , mean LDL particle size increased with colesevelam HCl 3.75 g/d ( 1.1 % increase versus baseline , P patients with moderate hypercholesterolemia , treatment with colesevelam HCl at the recommended starting dose of 3.75 g/d lowered LDL particle number , and increased mean LDL particle size",
"4The aim of this study was to evaluate changes in lipid profiles in patients with type 2 diabetes after treatment conversion from rosiglitazone to pioglitazone while maintaining stable statin and other lipid-altering therapies . A total of 305 patients were enrolled in this open-label study . Patients had been taking stable dosages of rosiglitazone and statins for > 90 days . At baseline , patients discontinued rosiglitazone and started pioglitazone 30 mg/day , but continued statins and other lipid-altering therapies . The primary end point was change from baseline in fasting triglyceride levels . At 17 weeks after treatment conversion , patients had significant reductions in triglycerides ( -15.2 % ) , total cholesterol ( -9.0 % ) , and low-density lipoprotein ( LDL ) particle concentration ( -189 nmol/L ) , and increases in LDL cholesterol ( + 2.2 % ) , high-density lipoprotein ( HDL ) cholesterol ( + 1.8 % ) , and LDL particle diameter ( + 0.23 nm ) . In conclusion , after treatment conversion from rosiglitazone to pioglitazone while maintaining stable statin therapy , patients with type 2 diabetes had marked improvements in lipid profiles along with stable glycaemic control",
"This study was conducted to determine the efficacy of atorvastatin and niacin on lipoprotein subfractions in patients with atherogenic dyslipidemia . This was a multicenter , r and omized , open-label , parallel- design study of patients with total cholesterol > 200 mg/dl , triglycerides between 200 and 800 mg/dl , and apolipoprotein B > 110 mg/dl . Patients were r and omly assigned to atorvastatin 10 mg or immediate release niacin 3,000 mg daily for 12 weeks following a low-fat diet stabilization period . Lipoprotein subclasses were measured by nuclear magnetic resonance spectroscopy . Atorvastatin and niacin both significantly reduced the concentrations of very low-density lipoprotein ( VLDL ) particles ( -31 % and -29 % , respectively ) and small low-density lipoprotein ( LDL ) particles ( -44 % and -35 % , respectively ) . Niacin increased the concentration of large LDL ( + 75 % ) . Atrovastatin reduced the number of LDL particles more than niacin ( 31 % vs 14 % ) . In patients with atherogenic dyslipidemia , both drugs had important effects on lipoprotein subfractions , which contributed to a reduction in coronary heart disease risk . The drugs equally reduced VLDL subclass levels . Niacin shifted the LDL subclass distribution toward the larger particles , more effectively converted patients from LDL phenotype B to phenotype A , and increased levels of the larger and perhaps more cardioprotective high-density lipoprotein particles . In contrast , atorvastatin preferentially lowered the concentration of small LDL particles without increasing levels of large LDL , and more effectively , reduced LDL particle numbers . Atorvastatin had a preferred LDL effect , whereas niacin had a preferred high-density lipoprotein effect",
"BACKGROUND Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) increases serum LDL-cholesterol ( LDL-C ) concentrations . We assessed the effects of AMG 145 , a human monoclonal antibody against PCSK9 , in patients with hypercholesterolaemia in the absence of concurrent lipid-lowering treatment . METHODS In a phase 2 trial done at 52 centres in Europe , the USA , Canada , and Australia , patients ( aged 18 - 75 years ) with serum LDL-C concentrations of 2·6 mmol/L or greater but less than 4·9 mmol/L were r and omly assigned equally through an interactive voice response system to subcutaneous injections of AMG 145 70 mg , 105 mg , or 140 mg , or placebo every 2 weeks ; subcutaneous AMG 145 280 mg , 350 mg , or 420 mg or placebo every 4 weeks ; or oral ezetimibe 10 mg/day . The primary endpoint was percentage change from baseline in LDL-C concentration at week 12 . Analysis was by modified intention to treat . Study personnel and patients were masked to treatment assignment of AMG 145 or placebo . Ezetimibe assignment was open label . This trial is registered with Clinical Trials.gov , number NCT01375777 . FINDINGS 406 patients were assigned to AMG 145 70 mg ( n=45 ) , 105 mg ( n=46 ) , or 140 mg ( n=45 ) every 2 weeks ; AMG 145 280 mg ( n=45 ) , 350 mg ( n=45 ) , or 420 mg ( n=45 ) every 4 weeks ; placebo every 2 weeks ( n=45 ) or every 4 weeks ( n=45 ) ; or ezetimibe ( n=45 ) . AMG 145 significantly reduced LDL-C concentrations in all dose groups ( mean baseline LDL-C concentration 3·7 mmol/L [ SD 0·6 ] ; changes from baseline with every 2 weeks AMG 145 70 mg -41·0 % [ 95 % CI -46·2 to -35·8 ] ; 105 mg -43·9 % [ -49·0 to -38·7 ] ; 140 mg -50·9 % [ -56·2 to -45·7 ] ; every 4 weeks AMG 145 280 mg -39·0 % [ -44·1 to -34·0 ] ; 350 mg -43·2 % [ -48·3 to -38·1 ] ; 420 mg -48·0 % [ -53·1 to -42·9 ] ; placebo every 2 weeks -3·7 % [ -9·0 to 1·6 ] ; placebo every 4 weeks 4·5 % [ -0·7 to 9·8 ] ; and ezetimibe -14·7 % [ -18·6 to -10·8 ] ; p placebo or ezetimibe ) . Treatment-emergent adverse events occurred in 136 ( 50 % ) of 271 patients in the AMG 145 groups , 41 ( 46 % ) of 90 patients in the placebo groups , and 26 ( 58 % ) of 45 patients in the ezetimibe group ; no deaths or serious treatment-related adverse events were reported . INTERPRETATION The results of our study support the further assessment of AMG 145 in long-term studies with larger and more diverse population s including patients with documented statin intolerance . FUNDING Amgen",
"Twenty subjects with mixed hyperlipidemia participated in a 3-arm crossover trial to evaluate the effectiveness of high-dose simvastatin as monotherapy . Significant reductions were observed in atherogenic lipids and lipoproteins . The highest dose of simvastatin also result ed in significant increases in high-density lipoprotein cholesterol ( 21 % ) with a comparable increase in large , protective high-density lipoprotein particles",
"The effects of atorvastatin at 20 , 40 , and 80 mg/day on plasma lipoprotein subspecies were examined in a r and omized , placebo-controlled fashion over 36 weeks in 97 patients with coronary heart disease ( CHD ) with low-density lipoprotein ( LDL ) cholesterol levels of > 130 mg/dl and compared directly with the effects of fluvastatin ( n = 28 ) , pravastatin ( n = 22 ) , lovastatin ( n = 24 ) , and simvastatin ( n = 25 ) . The effects of placebo and 40 mg/day of each statin were also examined in subjects with CHD with subjects in the fasting state and in the fed state 4 hours after a meal rich in saturated fat and cholesterol and compared with results in age- and gender-matched control subjects . At all doses tested in the fasting and fed states , atorvastatin was significantly ( p lowering LDL cholesterol and non-high-density lipoprotein ( HDL ) cholesterol than all other statins , and significantly ( p simvastatin , in lowering triglyceride and remnant lipoprotein ( RLP ) cholesterol . At 40 mg/day in the fasting state , atorvastatin was significantly ( p lovastatin and simvastatin , in lowering cholesterol levels in small LDL , and was significantly ( p simvastatin , in increasing cholesterol in large HDL and in lowering LDL particle numbers . Our data indicate that atorvastatin was the most effective statin tested in lowering cholesterol in LDL , non-HDL , and RLP in the fasting and fed states , and getting patients with CHD to established goals , with fluvastatin , pravastatin , lovastatin , and simvastatin having about 33 % , 50 % , 60 % , and 85 % of the efficacy of atorvastatin , respectively , at the same dose in the same patients",
"Fibrates reduce triglycerides ( TG ) and increase HDL-cholesterol levels , but there was no report showing plaque regression by fibrates . Using MRI , we investigated the effects of bezafibrate on aortic plaques in 22 dyslipidemic patients . All patients were asked to receive 400 mg bezafibrate , but 8 who declined to have bezafibrate became the control group . Changes in vessel wall area ( VWA ) and lumen area ( LA ) from baseline to 1-year were evaluated . Bezafibrate reduced TG ( -55 % ) and increased HDL-cholesterol levels ( + 29 % ) . Bezafibrate reduced HDL size and increased LDL size . In thoracic plaques , bezafibrate reduced VWA ( -6 % , P bezafibrate ( + 5 % ) . In abdominal plaques , bezafibrate reduced VWA ( -8 % , P LA increase ( + 3 % , P VWA progressed without bezafibrate ( + 6 % ) . VWA changes in thoracic and abdominal plaques correlated with TG reduction and HDL-cholesterol increase . Notably , VWA change in only abdominal plaques correlated with HDL size reduction and LDL size increase . Thus , bezafibrate induced plaque regression in thoracic and abdominal aortas with marked TG reduction and HDL-cholesterol increase , but the processes of plaque regression and vascular remodeling may differ between thoracic and abdominal aortas . However , because our study was not a controlled , r and omized trial , further study is needed",
"BACKGROUND The importance of the number of circulating low-density lipoprotein ( LDL ) cholesterol particles , in addition to total LDL level , has been increasingly recognized . The effects of extended-release niacin ( ERN ) on LDL particle numbers have not been studied . OBJECTIVE To evaluate ERN 's effects on LDL particle numbers . METHODS Fifty-four patients with stable coronary artery disease ( CAD ) and well-controlled LDL levels were r and omly assigned to 3 months of ERN ( 1 g/day ) or placebo in addition to their baseline medications . Lipoprotein particle number was analyzed by proton nuclear magnetic resonance spectroscopy at baseline and after 3 months . RESULTS Compared to baseline , the addition of ERN had no significant effect on total LDL cholesterol levels ; however , ERN decreased the number of medium and small LDL particles ( P number of medium and small LDL particles compared to placebo-treated patients ( P ERN raised HDL cholesterol levels by 2.7 % , significantly increased the number of large HDL particles ( P number of small HDL particles ( P = .027 ) compared to placebo . There were no significant changes in lipid values or particle numbers in the placebo-treated patients . In patients with stable coronary artery disease and well-controlled LDL cholesterol levels , ERN reduced the number of circulating particles of the more atherogenic subtypes of LDL , despite having no effect on total LDL cholesterol levels . ERN also favorably altered the number of HDL particles . CONCLUSION ERN-induced alterations in lipoprotein particle numbers may contribute to its anti-atherosclerotic effects , and these effects may not be evident from the st and ard lipid profile",
"Hypertriglyceridemia is often associated with small dense low density lipoprotein ( LDL ) , elevated remnants , and decreased high density lipoprotein (HDL)-cholesterol ( C ) , which comprise the dyslipidemic triad . The objective of this study was to investigate the effect of fenofibrate on the lipoprotein subfraction profile and inflammation markers in hypertriglyceridemic men . Twenty hypertriglyceridemic men were administered fenofibrate , 200 mg daily , for 8 weeks . Lipoprotein subclasses were measured by nuclear magnetic resonance ( NMR ) spectroscopy . Inflammation markers including C-reactive protein ( CRP ) , interleukin-6 ( IL-6 ) , and monocyte chemotactic protein-1 ( MCP-1 ) were also determined . Fenofibrate lowered triglyceride ( TG ) by 58 % and increased HDL-C by 18 % . NMR analysis revealed that very low density lipoprotein ( VLDL ) , particularly large VLDL , intermediate density lipoprotein ( IDL ) , and small LDL , were significantly decreased , and LDL distribution shifted towards the larger particles . HDL distribution was altered ; there was an increase in small HDL and a decrease in large HDL , result ing in a significant decrease in HDL particle size , from 9.1 to 8.9 nm , as well as a 27 % increase in HDL particle number . Among inflammation markers , CRP was significantly decreased by 42 % . In conclusion , fenofibrate effectively improves atherogenic dyslipidemia by reducing remnants and small LDL , as well as by increasing HDL particles . These effects , together with the favorable effect on inflammation , might provide a clinical benefit in hypertriglyceridemic subjects",
"BACKGROUND Dyslipidaemia is very common in patients with HIV infection , but current therapies are often suboptimal . Since niacin may cause insulin resistance and hepatotoxicity , it has generally been avoided in this setting . METHODS Non-diabetic male subjects ( n=33 ) who had well-controlled HIV infection on antiretroviral therapy , fasting triglycerides > or = 2.26 mmol/l and non-high density lipoprotein cholesterol ( non-HDL-C ) > or = 4.66 mmol/l received escalating doses of extended-release niacin ( ERN ) up to 2,000 mg nightly for up to 44 weeks . RESULTS Fourteen subjects ( 42 % ) had pre-diabetes at entry . Twenty-three subjects ( 70 % ) received the maximum dose , eight ( 24 % ) received 1,500 mg . Niacin was well-tolerated . Only four subjects ( 12 % ) discontinued study treatment . There were small increases in fasting glycaemia and insulin resistance estimated by the homeostasis model assessment , but insulin resistance measures from the 2-h oral glucose tolerance test only transiently worsened . No subject developed persistent fasting hyperglycaemia ; one had persistently elevated 2-h glucose > 11.1 mmol/l . There were no significant changes in serum transaminases or uric acid . At week 48 , the median change in fasting lipid levels in mmol/l ( interquartile range ) were : total cholesterol -0.21 ( -1.35 , -0.05 ) , HDL-C + 0.013 ( -0.03,+0.28 ) , non-HDL-C -0.49 ( -1.37,+0.08 ) and triglycerides -1.73 ( -3.68 , -0.72 ) . Favourable changes in large HDL and large very low density lipoprotein particle concentration were observed by nuclear magnetic resonance spectroscopy . CONCLUSIONS ERN in doses up to 2,000 mg daily was safe , well-tolerated and efficacious in HIV-infected subjects with atherogenic dyslipidaemia . Increases in glycaemia and insulin resistance tended to be transient",
"The effect of statin therapy on subclasses of LDL , VLDL and HDL lipoproteins is unclear . We compared changes in serum lipids , apolipoproteins and nuclear magnetic resonance ( NMR ) spectroscopy measured lipoprotein subclass concentration and average particle size over a minimum 6 months treatment period of atorvastatin 10 mg vs. placebo in 122 men and women . All subjects had type 2 diabetes and a modest dyslipidaemia ( mean LDL-cholesterol 3.2 mmol/l and median triglycerides 1.8 mmol/l ) and had a previous myocardial infa rct ion . Compared with placebo , atorvastatin therapy was associated with a greater decrease in medium VLDL ( median within person change -13.4 vs. -5.9 nmol/l , P small VLDL ( median change -17.8 vs. -8.1 nmol/l , P=0.002 ) , large LDL ( mean within person change -167.9 vs. -48.6 nmol/l , P medium LDL ( median within person change -101.8 vs. -22.3 nmol/l , P=0.017 ) . Atorvastatin therapy was also associated with a greater increase in large HDL than placebo ( median change 1.40 vs. 0.80 micromol/l , P=0.02 ) and there was little change in small HDL so that average HDL particle size increased significantly with atorvastatin ( P=0.04 ) . In addition to reducing levels of ( enzymatically measured ) triglyceride , LDL-cholesterol and apolipoprotein B in diabetic patients , atorvastatin significantly reduces NMR measured medium and small VLDL and large and medium LDL , and increases large HDL",
"BACKGROUND : Lowering low-density lipoprotein cholesterol ( LDL-C ) with statins reduces atherosclerosis . LDL and high-density lipoprotein ( HDL ) are commonly measured by their cholesterol content , but non-HDL cholesterol , LDL particle number ( LDL-P ) , or total apolipoprotein B ( apoB ) may better predict cardiovascular risk . Few studies have examined relations among lipoprotein levels and composition before and after interventions to lower LDL-C and non-HDL-C. OBJECTIVE : To measure changes in carotid artery intimal media thickness ( CIMT ) and lipid concentration and composition during 36 months of statin therapy . METHODS : Analyses were conducted on 418 diabetic individuals , with complete data and no prior cardiovascular events , who were r and omized to aggressive ( AG ) versus st and ard ( STD ) treatment for LDL-C , non-HDL-C , and systolic blood pressure ( SBP ) as part of the Stop Atherosclerosis in Native Diabetics Study ( S AND S ) . RESULTS : The AG group achieved average LDL-C and non-HDL-C of 71mg/dL and 100mg/dL and a decrease in CIMT . No significant interactions were observed between treatment effect and initial levels of LDL-C , non-HDL-C , HDL-C , triglycerides , apoB , or LDL-P. Decreases in LDL-C ( p non-HDL-C ( p Changes in apoB and LDL-P showed borderline correlations with CIMT regression ( p=.07 and p=.09 ) . CONCLUSIONS : In diabetic adults with no prior cardiovascular events , treatment to current targets for lipids and SBP reduces atherosclerosis progression and when more aggressive targets are met , atherosclerosis regresses . The aggressive targets for LDL-C and non-HDL-C appeared to be the main determinants of CIMT regression and were more predictive of this outcome than changes in LDL-P or",
"BACKGROUND A potentially atherogenic lipid profile often found in patients with type 2 diabetes mellitus ( T2DM ) includes increased concentrations of small , low-density lipoprotein ( LDL ) and intermediate-density lipoprotein ( IDL ) and decreased concentration of medium/large high-density lipoprotein ( HDL ) particles . Extended-release niacin/laropiprant ( ERN/LRPT ) lowers LDL-cholesterol ( LDL-C ) and triglycerides ( TG ) , and raises HDL cholesterol ( HDL-C ) levels with attenuation of niacin-induced flushing . METHODS Plasma HDL , LDL , IDL , very-low-density lipoprotein ( VLDL ) , and chylomicron particle concentration and size at were evaluated at baseline and week 12 using nuclear magnetic resonance ( NMR ) . The data were acquired from a r and omized , multicenter , double-blind , placebo-controlled study including 796 patients with T2DM treated with either 1 tablet of ERN 1 gram/LRPT 20 mg or matching placebo daily , increased after 4 weeks to 2 tablets daily . RESULTS ERN/LRPT significantly ( P≤0.001 for all ) reduced LDL-C 17.9 % and TG 23.1 % , and increased HDL-C levels 23.2 % . Compared to placebo , ERN/LRPT decreased LDL , IDL , VLDL , and chylomicron particle concentrations [ median concentration of smallest LDL particles decreased 16.6 % , 95 % confidence interval ( CI ) -22.3 , -10.9 , whereas the largest LDL particles decreased 11.0 % , 95 % CI -18.7 , -3.2 , and total VLDL/chylomicron mean plasma particle concentration decreased 34.7 % , 95 % CI -41.3 , -28.1 ] . Compared to placebo , ERN/LRPT shifted the distribution of HDL particle diameter from smaller to larger ( median concentration of the largest HDL particles increased 32.7 % ( 95 % CI 25.30 , 40.58 ) , whereas concentration of the smallest HDL particles decreased 8.2 % ( 95 % CI -11.29 , -5.06 ) . CONCLUSIONS Compared with placebo in patients with T2DM , ERN/LRPT shifted the lipoprotein profile toward a potentially less atherogenic pattern with reduced atherogenic LDL and IDL particle concentrations , and increased large HDL plasma particle concentrations . ( Clinical Trials.gov : NCT00485758 )",
"OBJECTIVE We compared the effects of diet/exercise induce weight loss versus pioglitazone on lipoprotein particle characteristics in non-diabetic , insulin resistant adults to determine whether the responses and potential mechanisms for improvement are similar between these two insulin sensitizing regimens . METHODS AND RESULTS Thirty-seven obese , insulin resistant volunteers were r and omized to 19 weeks of either pioglitazone or diet/exercise treatment . Insulin sensitivity ( Si ) by IVGTT and lipoprotein subclass particle profiles by NMR was measured . Only diet/exercise lowered TG ( -40+/-11 mg/dL ) , total ( -29+/-4 mg/dL ) and LDL cholesterol ( -20+/-4 mg/dL ; all p diet/exercise and pioglitazone improved Si ( p total LDL particles ( -227+/-40 and -149+/-21 nmol/L , respectively , both p small LDL particles ( -242+/-58 and -226+/-36 , respectively , both p Large LDL particle concentrations increased with both treatments . LDL particle subclasses changes correlated with changes in Si only in the diet/exercise group . CONCLUSION In obese , insulin resistant non-diabetic adults , pioglitazone improved LDL particle characteristics in a manner similar to diet/exercise without changing TG , diabetic control , total or LDL cholesterol . This effect could have implication s for atherosclerotic risk",
"The efficacy of extended-release niacin ( niacin ER ) on lipoprotein subclasses was evaluated in patients with primary hypercholesterolemia using a proton nuclear magnetic resonance method . Paired plasma sample s collected at baseline and after 12 weeks ' treatment with niacin ER 1,000 ( n = 21 ) or 2,000 ( n = 20 ) mg/day or placebo ( n = 19 ) were available for 60 eligible patients from a previous multicenter , r and omized , controlled trial . Niacin ER increased high-density lipoprotein ( HDL ) cholesterol and decreased low-density lipoprotein ( LDL ) cholesterol and very low-density lipoprotein triglycerides in a dose-dependent manner relative to placebo . Niacin ER increased large HDL particles ( H5 and H4 , corresponding to the HDL(2ab ) fraction ) without having a net effect on small HDL particles ( H3 , H2 , and H1 , corresponding to the HDL(3abc ) fraction ) . It also decreased smaller , denser LDL particles ( L1 and L2 ) and increased the larger , more buoyant L3 subclass . The inhibitory effect of niacin ER on very low-density lipoprotein was evident on the larger particles ( V6 , V5 , V4 , and V3 subclasses ) rather than the smaller ones ( V2 and V1 ) . The results show that niacin ER produces a beneficial effect on lipoprotein subclasses , specifically decreasing the more atherogenic small , dense LDL particles and enhancing the cardioprotective large HDL particles",
"BACKGROUND Niacin has multiple lipoprotein effects that may provide cardiovascular benefit when added to statin monotherapy . METHODS In this r and omized , placebo-controlled trial ( n = 75 ) of magnetic resonance imaging of carotid atherosclerosis , we performed a secondary comparison of combination niacin-statin ( simvastatin 20 mg/Niacin-ER 2 G [ S20/N ] ) to monotherapy with moderate ( 20 mg [ S20 ] ) and high-dose ( 80 mg [ S80 ] ) simvastatin on lipids , apolipoproteins ( apo ) , low density lipoprotein ( LDL ) and high density lipoprotein ( HDL ) particle subclasses , and inflammatory markers . RESULTS At baseline , average age was 71 , 72 % were male , 62.5 % used statins , and average LDL-cholesterol was 111 mg/dL. At 12 months , S20/N , compared to S80 , significantly reduced apoB ( -36.6 % vs -11.9 % ; P = .05 ) and lipoprotein(a ) ( -18 % vs + 3.5 % ; P = .001 ) and had at least an equivalent effect on LDL-cholesterol ( -39.3 % vs -24.3 % ; P = .24 ) . The combination reduced the proportion of subjects with atherogenic LDL pattern-B ( 50 % to 11.5 % ) compared to S80 ( 56 % to 56 % ) ( P = .01 ) . Despite increases in plasma free fatty acids ( + 62.4 % ; F = 5.65 , P = .005 vs S20 and S80 ) , plasma triglycerides ( -29.4 % ; F = 6.88 , P = .002 vs S20 and S80 ) , and very-low-density lipoprotein ( -44.2 % ; F = 7.94 , P HDL-cholesterol levels ( + 18.1 % ) as compared to S20 ( 0 % ) and S80 ( + 5.9 % ) ( P HDL particle size ( + 4.6 % ; P = .01 vs both statin arms ) . CONCLUSIONS We demonstrate that full-dose niacin/moderate-dose simvastatin combination has sustained benefits on atherogenic apoB lipoproteins , at least comparable to high-dose simvastatin , while also raising HDL-cholesterol . Results of large clinical trials will inform whether niacin-statin combinations reduce cardiovascular disease events",
"OBJECTIVE To evaluate the efficacy and safety of initial combination therapy with metformin plus colesevelam in patients with early type 2 diabetes . METHODS In this 16-week , r and omized , double-blind , placebo-controlled study , adults with type 2 diabetes ( hemoglobin A1c [ A1C ] values of 6.5 % to 10.0 % ) and hypercholesterolemia ( low-density lipoprotein cholesterol [ LDL-C ] levels > or = 100 mg/dL ) were r and omly assigned ( 1:1 ) to colesevelam ( 3.75 g/d ) or placebo in combination with open-label metformin ( 850 mg/d ; uptitrated at week 2 to 1,700 mg/d ) . The primary efficacy evaluation was change in A1C from baseline to study end ( week 16 with last observation carried forward ) . RESULTS In total , 286 patients were r and omized : metformin/colesevelam ( n = 145 ) or metformin/placebo ( n = 141 ) . Mean A1C was reduced by 1.1 % with metformin/colesevelam ( from 7.8 % at baseline to 6.6 % at study end ) and by 0.8 % with metformin/placebo ( from 7.5 % to 6.7 % ) , result ing in a treatment difference of -0.3 % at study end ( P = .0035 ) . In addition , metformin/colesevelam significantly reduced LDL-C ( -16.3 % ) , total cholesterol ( -6.1 % ) , non-high-density lipoprotein cholesterol ( -8.3 % ) , apolipoprotein B ( -8.0 % ) , and high-sensitivity C-reactive protein ( -17 % ) and increased apolipoprotein A-I ( + 4.4 % ) and triglycerides ( + 18.6 % ) versus metformin/placebo ( P metformin/colesevelam versus metformin/placebo , respectively , were as follows : A1C LDL-C Safety and tolerability were similar between the treatment groups . CONCLUSION Metformin plus colesevelam may be a valid option for initial therapy to achieve glycemic and lipid goals safely in early type 2 diabetes",
"BACKGROUND The bile acid sequestrant colesevelam has been shown to significantly reduce low-density lipoprotein particle concentration ( LDL-P ) in adults with primary hyperlipidemia or type 2 diabetes mellitus ( T2DM ) . OBJECTIVE To assess the effect of initial combination therapy with metformin plus colesevelam on lipoprotein particles in patients with T2DM ( secondary efficacy variables ) . METHODS This 16-week , r and omized , double-blind , placebo-controlled study enrolled drug-naïve adults with T2DM , glycated hemoglobin 6.5%-10.0 % , low-density lipoprotein cholesterol ( LDL-C ) ≥100 mg/dL , and triglycerides Patients were r and omized 1:1 to either open-label metformin ( titrated to 1700 mg/day ) plus double-blind colesevelam 3.75 g/day or open-label metformin plus double-blind placebo . RESULTS In total , 286 patients were r and omized ( metformin plus colesevelam [ n = 145 ] ; metformin plus placebo [ n = 141 ] ) . Compared with metformin plus placebo , the combination of metformin plus colesevelam significantly reduced LDL-C ( mean treatment difference : -16.3 % ) , total cholesterol ( -6.1 % ) , non-high-density lipoprotein cholesterol ( -8.3 % ) , and apolipoprotein ( apo ) B ( -8.0 % ) and significantly increased triglycerides ( median treatment difference : 18.6 % ) and apoA-I ( mean treatment difference : 4.4 % ; all P ) . Metformin plus colesevelam significantly reduced total LDL-P ( mean treatment difference : absolute change -186 nmol/L [ percent change -11.7 % ] ; both P to a reduction in small LDL-P , and increased total very-low-density lipoprotein particle concentration ( mean treatment difference : absolute change 6 nmol/L ; P = .03 [ percent change 8.3 % ; P = .06 ] ) and total high-density lipoprotein particle concentration ( 1.0 μmol/L ; P = .03 [ 4.5 % ; P = .01 ] ) versus metformin plus placebo . CONCLUSION Initial combination therapy with metformin plus colesevelam improved the atherogenic lipoprotein profile of patients with early T2DM by significantly reducing LDL-P. Clinical Trials.gov identifier : NCT00570739"
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Background : The aim of the study was a systematic review of studies evaluating psychotherapeutic treatment approaches in anorexia nervosa and to compare their efficacy . Weight gain was chosen as the primary outcome criterion . We also aim ed to compare treatment effects according to service level ( inpatient vs. outpatient ) and age group ( adolescents vs. adults ) . Methods : The data bases PubMed , Cochrane Library , Web of Science , Cinahl , and PsychInfo were used for a systematic literature search ( until Feb 2017 ) . Search terms were adapted for data base , combining versions of the search terms anorexia , treat*/therap * and controlled trial . Studies were selected using pre-defined in- and exclusion criteria . Data were extracted by two independent coders using piloted forms . Network-meta-analyses were conducted on all RCTs . For a comparison of service levels and age groups , st and ard mean change ( SMC ) statistics were used and naturalistic , non-r and omized studies included . Results : Eighteen RCTs ( trials on adults : 622 participants ; trials on adolescents : 625 participants ) were included in the network meta- analysis . SMC analyses were conducted with 38 studies ( 1,164 participants ) . While family-based approaches dominate interventions for adolescents , individual psychotherapy dominates in adults . There was no superiority of a specific approach . Weight gains were more rapid in adolescents and inpatient treatment . Conclusions : Several specialized psychotherapeutic interventions have been developed and can be recommended for AN . However , adult and adolescent patients should be distinguished , as groups differ in terms of treatment approaches considered suitable as well as treatment response . Future trials should replicate previous findings and be multi-center trials with large sample sizes to allow for subgroup analyses . Patient assessment should include variables that can be considered relevant moderators of treatment outcome . It is desirable to explore adaptive treatment strategies for subgroups of patients with AN . Identifying and addressing maintaining factors in AN remains a major challenge
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"IMPORTANCE Anorexia nervosa ( AN ) is a serious disorder with high rates of morbidity and mortality . Family-based treatment ( FBT ) is an evidence -based therapy for adolescent AN , but less than half of those who receive this approach recover . Hence , it is important to identify other approaches to prevent the development of the chronic form of AN for which there is no known evidence -based treatment . OBJECTIVE To compare FBT with systemic family therapy ( SyFT ) for the treatment of adolescent-onset AN . DESIGN , SETTING , AND PARTICIPANTS Research in Anorexia Nervosa ( RIAN ) is a 2-group ( FBT and SyFT ) r and omized trial conducted between September 2005 and April 2012 . Interviewers were blinded to the treatment condition . A total of 564 adolescents receiving care at 6 outpatient clinics experienced in the treatment of AN were screened . Of these , 262 adolescents did not meet the inclusion criteria and 138 declined to participate ; hence , 164 adolescents ( aged 12 - 18 years ) of both sexes meeting the criteria for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , AN ( except for amenorrhea ) were enrolled . Three participants were withdrawn from FBT and 7 were withdrawn from SyFT after serious adverse events occurred . INTERVENTIONS Two manualized family therapies with 16 one-hour sessions during 9 months . Family-based therapy focuses on the facilitation of weight gain , whereas SyFT addresses general family processes . MAIN OUTCOMES AND MEASURES The primary outcomes were percentage of ideal body weight ( IBW ) and remission ( ≥95 % of IBW ) . The a priori hypothesis was that FBT would result in faster weight gain early in treatment and at the end of treatment ( EOT ) . RESULTS There were no statistically significant differences between treatment groups for the primary outcome , for eating disorder symptoms or comorbid psychiatric disorders at the EOT or follow-up . Remission rates included FBT , 33.1 % at the EOT and 40.7 % at follow-up and SyFT , 25.3 % and 39.0 % , respectively . Family-based therapy led to significantly faster weight gain early in treatment , significantly fewer days in the hospital , and lower treatment costs per patient in remission at the EOT ( FBT , $ 8963 ; SyFT , $ 18 005 ) . An exploratory moderator analysis found that SyFT led to greater weight gain than did FBT for participants with more severe obsessive-compulsive symptoms . CONCLUSIONS AND RELEVANCE The findings of this study suggest that FBT is the preferred treatment for adolescent AN because it is not significantly different from SyFT and leads to similar outcomes at a lower cost than SyFT . Adolescents with more severe obsessive-compulsive symptoms may receive more benefits with SyFT . TRIAL REGISTRATION clinical trials.gov Identifier NCT00610753",
"BACKGROUND Habits are behavioral routines that are automatic and frequent , relatively independent of any desired outcome , and have potent antecedent cues . Among individuals with anorexia nervosa ( AN ) , behaviors that promote the starved state appear habitual , and this is the foundation of a recent neurobiological model of AN . In this proof-of-concept study , we tested the habit model of AN by examining the impact of an intervention focused on antecedent cues for eating disorder routines . METHODS The primary intervention target was habit strength ; we also measured clinical impact via eating disorder psychopathology and actual eating . Twenty-two hospitalized patients with AN were r and omly assigned to 12 sessions of either Supportive Psychotherapy or a behavioral intervention aim ed at cues for maladaptive behavioral routines , Regulating Emotions and Changing Habits ( REaCH ) . RESULTS Covarying for baseline , REaCH was associated with a significantly lower Self-Report Habit Index ( SRHI ) score and significantly lower Eating Disorder Examination- Question naire ( EDE-Q ) global score at the end-of-treatment . The end-of-treatment effect size for SRHI was d = 1.28 , for EDE-Q was d = 0.81 , and for caloric intake was d = 1.16 . CONCLUSIONS REaCH changed habit strength of maladaptive routines more than an active control therapy , and targeting habit strength yielded improvement in clinical ly meaningful measures . These findings support a habit-based model of AN , and suggest habit strength as a mechanism-based target for intervention",
"OBJECTIVE Anorexia nervosa ( AN ) is a severe illness with high rates of relapse . Exposure and Response Prevention for AN ( AN-EXRP ) is a new approach that specifically addresses maladaptive eating behavior by targeting eating-related fear and anxiety . The aim of this study was to evaluate AN-EXRP as an adjunctive strategy to improve eating behavior during weight restoration , at a pivotal moment when treatment goals shift toward relapse prevention . METHOD A r and omized controlled trial was conducted to compare AN-EXRP with a comparison condition , Cognitive Remediation Therapy ( CRT ) . Hospitalized patients with AN ( n = 32 ) who had achieved weight restoration to a BMI > 18.5 kg/m(2 ) received 12 sessions of either AN-EXRP or CRT . Outcome was assessed by change in caloric intake in an objective assessment of eating behavior . RESULTS The average test meal caloric intake of participants who received AN-EXRP increased from 352 ± 263 kcal at baseline to 401 ± 215 kcal post-treatment , while that of participants who received CRT decreased from 501 ± 232 kcal at baseline to 424 ± 221 kcal post-treatment [ t(28 ) = 2.5 , p = .02 ] . Improvement in intake was significantly associated with improvement in eating-related anxiety ( Spearman 's ρ = 0.40 , p = .03 ) . DISCUSSION These data demonstrate that AN-EXRP , compared to a credible comparison intervention , is associated with better caloric intake in a laboratory meal over time in AN . Additional studies are required to determine whether incorporation of these techniques into a longer treatment program leads to enduring and clinical ly significant change",
"This study aim ed to determine predictors of BMI and recovery for out patients with anorexia nervosa ( AN ) . Patients were participants of the ANTOP ( Anorexia Nervosa Treatment of Out- Patients ) trial and r and omized to focal psychodynamic therapy ( FPT ) , enhanced cognitive behavior therapy ( CBT-E ) , or optimized treatment as usual ( TAU-O ) . N=169 patients participated in the one-year follow-up ( T4 ) . Outcomes were the BMI and global outcome ( recovery/partial syndrome/full syndrome ) at T4 . We examined the following baseline variables as possible predictors : age , BMI , duration of illness , subtype of AN , various axis I diagnoses , quality of life , self-esteem , and psychological characteristics relevant to AN . Linear and logistic regression analyses were conducted to identify the predictors of the BMI and global outcome . The strongest positive predictor for BMI and recovery at T4 was a higher baseline BMI of the patients . Negative predictors for BMI and recovery were a duration of illness > 6 years and a lifetime depression diagnosis at baseline . Additionally , higher bodily pain was significantly associated with a lower BMI and self-esteem was a positive predictor for recovery at T4 . A higher baseline BMI and shorter illness duration led to a better outcome . Further research is necessary to investigate whether or not AN patients with lifetime depression , higher bodily pain , and lower self-esteem may benefit from specific treatment approaches",
"BACKGROUND Very limited evidence is available on how to treat adults with anorexia nervosa and treatment outcomes are poor . Novel treatment approaches are urgently needed . AIMS To evaluate the efficacy and acceptability of a novel psychological therapy for anorexia nervosa ( Maudsley Model of Anorexia Nervosa Treatment for Adults , MANTRA ) compared with specialist supportive clinical management ( SSCM ) in a r and omised controlled trial . METHOD Seventy-two adult out- patients with anorexia nervosa or eating disorder not otherwise specified were recruited from a specialist eating disorder service in the UK . Participants were r and omly allocated to 20 once weekly sessions of MANTRA or SSCM and optional additional sessions depending on severity and clinical need ( trial registration : IS RCT N62920529 ) . The primary outcomes were body mass index , weight and global score on the Eating Disorders Examination at end of treatment ( 6 months ) and follow-up ( 12 months ) . Secondary outcomes included : depression , anxiety and clinical impairment ; neuropsychological outcomes ; recovery rates ; and additional service utilisation . RESULTS At baseline , patients r and omised to MANTRA were significantly less likely to be in a partner relationship than those receiving SSCM ( 3/34 v. 10/36 ; P of eating disorder and other outcomes , with no differences between groups . Strictly defined recovery rates were low . However , MANTRA patients were significantly more likely to require additional in-patient or day-care treatment than those receiving SSCM ( 7/34 v. 0/37 ; P = 0.004 ) . CONCLUSIONS Adults with anorexia nervosa are a difficult to treat group . The imbalance between groups in partner relationships may explain differences in service utilisation favouring SSCM . This study confirms SSCM as a useful treatment for out- patients with anorexia nervosa . The novel treatment , MANTRA , design ed for this patient group may need adaptations to fully exploit its potential",
"BACKGROUND In-patient treatment ( IP ) is the treatment setting of choice for moderately-to-severely ill adolescents with anorexia nervosa , but it is costly , and the risks of relapse and readmissions are high . Day patient treatment ( DP ) is less expensive and might avoid problems of relapse and readmission by easing the transition from hospital to home . We investigated the safety and efficacy of DP after short inpatient care compared with continued IP . METHODS For this multicentre , r and omised , open-label , non-inferiority trial , we enrolled female patients ( aged 11 - 18 years ) with anorexia nervosa from six centres in Germany . Patients were eligible if they had a body-mass index ( BMI ) below the tenth percentile and it was their first admission to hospital for anorexia nervosa . We used a computer-generated r and omisation sequence to r and omly assign patients to continued IP or DP after 3 weeks of inpatient care ( 1:1 ; stratified for age and BMI at admission ) . The treatment programme and treatment intensity in both study groups were identical . The primary outcome was the increase in BMI between the time of admission and a 12-month follow-up adjusted for age and duration of illness ( non-inferiority margin of 0·75 kg/m(2 ) ) . Analysis was done by modified intention to treat . This trial is registered with the International St and ard R and omised Controlled Trial Number Register , number IS RCT N67783402 , and the Deutsches Register Klinischer Studien , number DRKS00000101 . FINDINGS Between Feb 2 , 2007 , to April 27 , 2010 , we screened 660 patients for eligibility , 172 of whom we r and omly allocated to treatment : 85 to IP and 87 to DP . DP was non-inferior to IP with respect to the primary outcome , BMI at the 12-month follow-up ( mean difference 0·46 kg/m(2 ) in favour of DP ( 95 % CI , -0·11 to 1·02 ; pnon-inferiority ) . The number of treatment-related serious adverse events was similar in both study groups ( eight in the IP group , seven in the DP group ) . Three serious adverse events in the IP group and two in the DP group were related to suicidal ideation ; one patient in the DP attempted suicide 3 months after she was discharged . INTERPRETATION DP after short inpatient care in adolescent patients with non-chronic anorexia nervosa seems no less effective than IP for weight restoration and maintenance during the first year after admission . Thus , DP might be a safe and less costly alternative to IP . Our results justify the broad implementation of this approach . FUNDING German Ministry for Education and Research",
"Background Considerable progress has been made in recent years in developing effective treatments for child and adolescent anorexia nervosa , with a general consensus in the field that eating disorders focussed family therapy ( often referred to as Maudsley Family Therapy or Family Based Treatment ) currently offers the most promising outcomes . Nevertheless , a significant number do not respond well and additional treatment developments are needed to improve outcomes . Multifamily therapy is a promising treatment that has attracted considerable interest and we report the results of the first r and omised controlled trial of multifamily therapy for adolescent anorexia nervosa . Methods The study was a pragmatic multicentre r and omised controlled superiority trial comparing two outpatient eating disorder focussed family interventions - multifamily therapy ( MFT-AN ) and single family therapy ( FT-AN ) . A total of 169 adolescents with a DSM-IV diagnosis of anorexia nervosa or eating disorder not otherwise specified ( restricting type ) were r and omised to the two treatments using computer generated blocks of r and om sizes to ensure balanced numbers in the trial arms . Independent assessors , blind to the allocation , completed evaluations at baseline , 3 months , 12 months ( end of treatment ) and 18 months . Results Both treatment groups showed clinical ly significant improvements with just under 60 % achieving a good or intermediate outcome ( on the Morgan-Russell scales ) at the end of treatment in the FT-AN group and more than 75 % in the MFT-AN group - a statistically significant benefit in favour of the multifamily intervention ( OR = 2.55 95 % ; CI 1.17 , 5.52 ; p = 0.019 ) . At follow-up ( 18 months post baseline ) there was relatively little change compared to end of treatment although the difference in primary outcome between the treatments was no longer statistically significant . Clinical ly significant gains in weight were accompanied by improvements in mood and eating disorder psychopathology . Approximately half the patients in FT-AN and nearly 60 % of those in MFT-AN had started menstruating . Conclusions This study confirms previous research findings demonstrating the effectiveness of eating disorder focused family therapy and highlights the additional benefits of bringing together groups of families that maximises the use of family re sources and mutual support leading to improved outcomes .Trial Registration Current Controlled Trials IS RCT N11275465 ; Registered 29 January 2007 ( retrospectively registered",
"BACKGROUND Currently , without systematic evidence , psychotherapy for anorexia nervosa in adults draws on psychodynamic , cognitive and systemic theories . AIMS To assess effectiveness of specific psychotherapies in out-patient management of adult patients with anorexia nervosa . METHOD Eighty-four patients were r and omised to four treatments : three specific psychotherapies - ( a ) a year of focal psychoanalytic psychotherapy ; ( b ) 7 months of cognitive-analytic therapy ( CAT ) ; ( c ) family therapy for 1 year - and ( d ) low contact , ' routine ' treatment for 1 year ( control ) . RESULTS At 1 year , there was symptomatic improvement in the whole group of patients . This improvement was modest , several patients being significantly undernourished at follow-up . Psychoanalytic psychotherapy and family therapy were significantly superior to the control treatment ; CAT tended to show benefits . CONCLUSIONS Psychoanalytic and family therapy are of specific value in the out-patient treatment of adult patients with anorexia",
"Background Individual , family and service level characteristics and outcomes are described for adult and adolescent patients receiving specialist inpatient or day patient treatment for anorexia nervosa ( AN ) . Potential predictors of treatment outcome are explored . Method Admission and discharge data were collected from patients admitted at 14 UK hospital treatment units for AN over a period of three years ( adult units N = 12 ; adolescent N = 2 ) ( patients N = 177 ) . Results One hundred and seventy-seven patients with a severe and enduring illness with wide functional impairment took part in the study . Following inpatient care , physical improvement was moderate/good with a large increase in BMI , although most patients continued to have a clinical level of eating disorder symptoms at discharge . The potentially modifiable predictors of outcome included confidence to change , social functioning and carer expressed emotion and control . Conclusions Overall , the response to inpatient treatment was modest particularly in the group with a severe enduring form of illness . Adolescents had a better response . Although inpatient treatment produces an improvement in physical health there was less improvement in other eating disorder and mood symptoms . As predicted by the carer interpersonal maintenance model , carer behaviour may influence the response to inpatient care , as may improved social functioning and confidence to change",
"OBJECTIVE There have been few r and omized clinical trials ( RCTs ) for adolescents with anorexia nervosa ( AN ) . Most of these posit that involving all family members in treatment supports favorable outcomes . However , at least 2 RCTs suggest that separate parent and adolescent sessions may be just as effective as conjoint treatment . This study compared the relative efficacy of family-based treatment ( FBT ) and parent-focused treatment ( PFT ) . In PFT , the therapist meets with the parents only , while a nurse monitors the patient . METHOD Participants ( N = 107 ) aged 12 to 18 years and meeting DSM 4(th)Edition criteria for AN or partial AN were r and omized to either FBT or PFT . Participants were assessed at baseline , end of treatment ( EOT ) , and at 6 and 12 months posttreatment . Treatments comprised 18 outpatient sessions over 6 months . The primary outcome was remission , defined as ≥95 % of median body mass index and Eating Disorder Examination Global Score within 1 SD of community norms . RESULTS Remission was higher in PFT than in FBT at EOT ( 43 % versus 22 % ; p = .016 , odds ratio [ OR ] = 3.03 , 95 % CI = 1.23 - 7.46 ) , but did not differ statistically at 6-month ( PFT 39 % versus FBT 22 % ; p = .053 , OR = 2.48 , CI = 0.989 - 6.22 ) , or 12-month ( PFT 37 % versus FBT 29 % ; p = .444 , OR = 1.39 , 95 % CI = 0.60 - 3.21 ) follow-up . Several treatment effect moderators of primary outcome were identified . CONCLUSION At EOT , PFT was more efficacious than FBT in bringing about remission in adolescents with AN . However , differences in remission rates between PFT and FBT at follow-up were not statistically significant . CLINICAL TRIAL REGISTRATION INFORMATION A R and omised Controlled Trial of Two Forms of Family-Based Treatment and the Effect on Percent Ideal Body Weight and Eating Disorders Symptoms in Adolescent Anorexia Nervosa ; http://www.anzctr.org.au/ ; ACTRN12610000216011",
"Anorexia nervosa is difficult to treat and no treatment is supported by robust evidence . As it is uncommon , it has been recommended that new treatments should undergo extensive preliminary testing before being evaluated in r and omized controlled trials . The aim of the present study was to establish the immediate and longer-term outcome following “ enhanced ” cognitive behaviour therapy ( CBT-E ) . Ninety-nine adult patients with marked anorexia nervosa ( body mass index ≤ 17.5 ) were recruited from consecutive referrals to clinics in the UK and Italy . Each was offered 40 sessions of CBT-E over 40 weeks with no concurrent treatment . Sixty-four percent of the patients were able to complete this outpatient treatment and in these patients there was a substantial increase in weight ( 7.47 kg , SD 4.93 ) and BMI ( 2.77 , SD 1.81 ) . Eating disorder features also improved markedly . Over the 60-week follow-up period there was little deterioration despite minimal additional treatment . These findings provide strong preliminary support for this use of CBT-E and justify its further evaluation in r and omized controlled trials . As CBT-E has already been established as a treatment for bulimia nervosa and eating disorder not otherwise specified , the findings also confirm that CBT-E is transdiagnostic in its scope",
"Background : The aim of this study was to compare the immediate and longer-term effects of two cognitive behaviour therapy programmes for hospitalized patients with anorexia nervosa , one focused exclusively on the patients ' eating disorder features and the other focused also on mood intolerance , clinical perfectionism , core low self-esteem or interpersonal difficulties . Both programmes were derived from enhanced cognitive behaviour therapy ( CBT-E ) for eating disorders . Methods : Eighty consecutive patients with severe anorexia nervosa were r and omized to the two inpatient CBT-E programmes , both of which involved 20 weeks of treatment ( 13 weeks as an inpatient and 7 as a day patient ) . The patients were then followed up over 12 months . The assessment s were made blind to treatment condition . Results : Eighty-one percent of the eligible patients accepted inpatient CBT-E , of whom 90 % completed the 20 weeks of treatment . The patients in both programmes showed significant improvements in weight , eating disorder and general psychopathology . Deterioration after discharge did occur but it was not marked and it was restricted to the first 6 months . There were no statistically significant differences between the effects of the two programmes . Conclusions : These findings suggest that both versions of inpatient CBT-E are well accepted by these severely ill patients and might be a viable and promising treatment for severe anorexia nervosa . There appears to be no benefit from using the more complex form of the treatment",
"Background Families express a need for information to support people with severe anorexia nervosa . Aims To examine the impact of the addition of a skills training intervention for caregivers ( Experienced Caregivers Helping Others , ECHO ) to st and ard care . Method Patients over the age of 12 ( mean age 26 years , duration 72 months illness ) with a primary diagnosis of anorexia nervosa and their caregivers were recruited from 15 in-patient services in the UK . Families were r and omised to ECHO ( a book , DVDs and five coaching sessions per caregiver ) or treatment as usual . Patient ( n=178 ) and caregiver ( n=268 ) outcomes were measured at discharge and 6 and 12 months after discharge . Results Patients with caregivers in the ECHO group had reduced eating disorder psychopathology ( EDE-Q ) and improved quality of life ( WHO-Quol ; both effects small ) and reduced in-patient bed days ( 7–12 months post-discharge ) . Caregivers in the ECHO group had reduced burden ( Eating Disorder Symptom Impact Scale , EDSIS ) , expressed emotion ( Family Question naire , FQ ) and time spent caregiving at 6 months but these effects were diminished at 12 months . Conclusions Small but sustained improvements in symptoms and bed use are seen in the intervention group . Moreover , caregivers were less burdened and spent less time providing care . Caregivers had most benefit at 6 months suggesting that booster sessions , perhaps jointly with the patients , may be needed to maintain the effect . Sharing skills and information with caregivers may be an effective way to improve outcomes . This r and omised controlled trial ( RCT ) was registered with Current Controlled Trials IS RCT N06149665 . Declaration of interest J.T. is a co-author of the book used in the ECHO intervention and receives royalties . Copyright and usage © The Royal College of Psychiatrists 2015 . This is an open access article distributed under the terms of the Creative Commons Non-Commercial , No Derivatives ( CC BY-NC-ND ) licence",
"Research on treatments in anorexia nervosa ( AN ) is scarce . Although most of the therapeutic programs used in ‘ real world practice ’ in AN treatment resort to multidisciplinary approaches , they have rarely been evaluated . Objective To compare two multidimensional post-hospitalization out patients treatment programs for adolescents with severe AN : Treatment as Usual ( TAU ) versus this treatment plus family therapy ( TAU+FT ) . Method Sixty female AN adolescents , aged 13 to 19 years , were included in a r and omized parallel controlled trial conducted from 1999 to 2002 for the recruitment , and until 2004 for the 18 months follow-up . Allocation to one of the two treatment groups ( 30 in each arm ) was r and omised . The TAU program included sessions for the patient alone as well as sessions with a psychiatrist for the patient and her parents . The TAU+FT program was identical to the usual one but also included family therapy sessions targeting intra-familial dynamics , but not eating disorder symptoms . The main Outcome Measure was the Morgan and Russell outcome category ( Good or Intermediate versus Poor outcome ) . Secondary outcome indicators included AN symptoms or their consequences ( eating symptoms , body mass index , amenorrhea , number of hospitalizations in the course of follow-up , social adjustment ) . The evaluators , but not participants , were blind to r and omization . Results At 18 months follow-up , we found a significant group effect for the Morgan and Russell outcome category in favor of the program with family therapy ( Intention-to-treat : TAU+FT : 12/30 ( 40 % ) ; TAU : 5/29 ( 17.2 % ) p = 0.05 ; Per Protocol analysis : respectively 12/26 ( 46.2 % ) ; 4/27 ( 14.8 % ) , p = 0.01 ) . Similar group effects were observed in terms of achievement of a healthy weight ( i.e. , BMI ≥10th percentile ) and menstrual status . Conclusions Adding family therapy sessions , focusing on intra-familial dynamics rather than eating symptomatology , to a multidimensional program improves treatment effectiveness in girls with severe AN . Trial Registration Controlled-trials.com IS RCT",
"BACKGROUND There are no evidence -based treatments for severe and enduring anorexia nervosa ( SE-AN ) . This study evaluated the relative efficacy of cognitive behavioral therapy ( CBT-AN ) and specialist supportive clinical management ( SSCM ) for adults with SE-AN . METHOD Sixty-three participants with a diagnosis of AN , who had at least a 7-year illness history , were treated in a multi-site r and omized controlled trial ( RCT ) . During 30 out-patient visits spread over 8 months , they received either CBT-AN or SSCM , both modified for SE-AN . Participants were assessed at baseline , end of treatment ( EOT ) , and at 6- and 12-month post-treatment follow-ups . The main outcome measures were quality of life , mood disorder symptoms and social adjustment . Weight , eating disorder ( ED ) psychopathology , motivation for change and health-care burden were secondary outcomes . RESULTS Thirty-one participants were r and omized to CBT-AN and 32 to SSCM with a retention rate of 85 % achieved at the end of the study . At EOT and follow-up , both groups showed significant improvement . There were no differences between treatment groups at EOT . At the 6-month follow-up , CBT-AN participants had higher scores on the Weissman Social Adjustment Scale ( WSAS ; p = 0.038 ) and at 12 months they had lower Eating Disorder Examination ( EDE ) global scores ( p = 0.004 ) and higher readiness for recovery ( p = 0.013 ) compared to SSCM . CONCLUSIONS Patients with SE-AN can make meaningful improvements with both therapies . Both treatments were acceptable and high retention rates at follow-up were achieved . Between-group differences at follow-up were consistent with the nature of the treatments given",
"BACKGROUND Previous research has found that many patients with anorexia nervosa ( AN ) are unable to maintain normal weight after weight restoration . The objective of this study was to identify variables that predicted successful weight maintenance among weight-restored AN patients . METHOD Ninety-three patients with AN treated at two sites ( Toronto and New York ) through in-patient or partial hospitalization achieved a minimally normal weight and were then r and omly assigned to receive fluoxetine or placebo along with cognitive behavioral therapy ( CBT ) for 1 year . Clinical , demographic and psychometric variables were assessed after weight restoration prior to r and omization and putative predictors of successful weight maintenance at 6 and 12 months were examined . RESULTS The most powerful predictors of weight maintenance at 6 and 12 months following weight restoration were pre-r and omization body mass index ( BMI ) and the rate of weight loss in the first 28 days following r and omization . Higher BMI and lower rate of weight loss were associated with greater likelihood of maintaining a normal BMI at 6 and 12 months . An additional predictor of weight maintenance was site ; patients in Toronto fared better than those in New York . CONCLUSIONS This study found that the best predictors of weight maintenance in weight-restored AN patients over 6 and 12 months were the level of weight restoration at the conclusion of acute treatment and the avoidance of weight loss immediately following intensive treatment . These results suggest that outcome might be improved by achieving a higher BMI during structured treatment programs and on preventing weight loss immediately following discharge from such programs",
"BACKGROUND Previous neuroimaging studies have demonstrated abnormalities in visual body image processing in anorexia and bulimia nervosa , possibly underlying body image disturbance in these disorders . Although cognitive behavioural interventions have been shown to be successful in improving body image disturbance in eating disorders , no r and omized controlled study has yet analysed treatment-induced changes in neuronal correlates of visual body image processing . METHOD Altogether , 32 females with eating disorders were r and omly assigned either to a manualized cognitive behavioural body image therapy consisting of 10 group sessions , or to a waiting list control condition . Using functional magnetic resonance imaging , brain responses to viewing photographs of one 's own and another female 's body taken from 16 st and ardized perspectives while participants were wearing a uniform bikini were acquired before and after the intervention and the waiting time , respectively . RESULTS Data indicate a general blood oxygen level dependent signal enhancement in response to looking at photographs of one 's own body from pre- to post-treatment , whereas exclusively in the control group activation decreases from pre- to post-waiting time were observed . Focused activation increases from pre- to post-treatment were found in the left middle temporal gyrus covering the coordinates of the extrastriate body area and in bilateral frontal structures including the middle frontal gyrus . CONCLUSIONS Results point to a more intense neuronal processing of one 's own body after the cognitive behavioural body image therapy in cortical regions that are responsible for the visual processing of the human body and for self-awareness",
"CONTEXT Evidence -based treatment trials for adolescents with anorexia nervosa are few . OBJECTIVE To evaluate the relative efficacy of family-based treatment ( FBT ) and adolescent-focused individual therapy ( AFT ) for adolescents with anorexia nervosa in full remission . DESIGN R and omized controlled trial . SETTING Stanford University and The University of Chicago ( April 2005 until March 2009 ) . PARTICIPANTS One hundred twenty-one participants , aged 12 through 18 years , with DSM-IV diagnosis of anorexia nervosa excluding the amenorrhea requirement . Intervention Twenty-four outpatient hours of treatment over 12 months of FBT or AFT . Participants were assessed at baseline , end of treatment ( EOT ) , and 6 months ' and 12 months ' follow-up posttreatment . MAIN OUTCOME MEASURES Full remission from anorexia nervosa defined as normal weight ( ≥95 % of expected for sex , age , and height ) and mean global Eating Disorder Examination score within 1 SD of published means . Secondary outcome measures included partial remission rates ( > 85 % of expected weight for height plus those who were in full remission ) and changes in body mass index percentile and eating-related psychopathology . RESULTS There were no differences in full remission between treatments at EOT . However , at both the 6- and 12-month follow-up , FBT was significantly superior to AFT on this measure . Family-based treatment was significantly superior for partial remission at EOT but not at follow-up . In addition , body mass index percentile at EOT was significantly superior for FBT , but this effect was not found at follow-up . Participants in FBT also had greater changes in Eating Disorder Examination score at EOT than those in AFT , but there were no differences at follow-up . CONCLUSION Although both treatments led to considerable improvement and were similarly effective in producing full remission at EOT , FBT was more effective in facilitating full remission at both follow-up points . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00149786",
"OBJECTIVE There are limited data supporting specific treatments for adults with anorexia nervosa ( AN ) . R and omized clinical trials ( RCTs ) for adults with AN are characterized by high attrition limiting the feasibility of conducting and interpreting existing studies . High dropout rates may be related to the inflexible and obsessional cognitive style of patients with AN . This study evaluated the feasibility of using cognitive remediation therapy ( CRT ) to reduce attrition in RCTs for AN . METHOD Forty-six participants ( mean age of 22.7 years and mean duration of AN of 6.4 years ) were r and omized to receive eight sessions of either CRT or cognitive behavioral therapy ( CBT ) over 2 months followed by 16 sessions of CBT for 4 months . RESULTS During the 2-month CRT vs. CBT treatment , rates of attrition were lower in CRT ( 13 % ) compared with that of CBT ( 33 % ) . There were greater improvements in cognitive inefficiencies in the CRT compared with that of the CBT group at the end of 2 months . There were no differences in other outcomes . DISCUSSION These results suggest that CRT is acceptable and feasible for use in RCTs for outpatient treatment of AN . CRT may reduce attrition in the short term . Adequately powered future studies are needed to examine CRT as an outpatient treatment for AN",
"Background : Individuals with eating disorders show deficits in neuropsychological functioning which might preexist and underlie the etiology of the eating disorders and influence relapse . Deficits in cognitive flexibility , i.e. set-shifting and central coherence , might perpetuate the symptoms . Cognitive remediation therapy ( CRT ) was developed to improve cognitive flexibility , thereby increasing the likelihood of improved outcome . The focus of CRT is on how patients think , rather than on what patients think . The present study investigated the effectiveness of CRT for patients with a severe or enduring eating disorder by means of a r and omized controlled trial comparing intensive treatment as usual ( TAU ) to CRT plus TAU . Methods : Eighty-two patients were r and omly assigned to CRT plus TAU ( n = 41 ) or TAU alone ( n = 41 ) . Outcome measures were set-shifting , central coherence , eating disorder and general psychopathology , motivation , quality of life and self-esteem . Assessment s were performed at baseline ( n = 82 ) and after 6 weeks ( T1 ; n = 75 ) and 6 months ( T2 ; n = 67 ) . Data were analyzed by means of linear mixed model analyses . Results : Patients who received CRT in addition to TAU improved significantly more with regard to eating disorder-related quality of life at the end of treatment ( T1 ) and eating disorder psychopathology at follow-up ( T2 ) , compared to those who received TAU only . Moreover , moderator analyses revealed that patients with poor baseline set-shifting abilities benefited more from CRT than patients with no deficits in set-shifting abilities at baseline ; the quality of life of the former group was higher than that of the latter at follow-up . Conclusions : CRT seems to be promising in enhancing the effectiveness of concurrent treatment",
"This paper reports the results of a r and omised treatment trial of two forms of outpatient family intervention for anorexia nervosa . Forty adolescent patients with anorexia nervosa were r and omly assigned to \" conjoint family therapy \" ( CFT ) or to \" separated family therapy \" ( SFT ) using a stratified design controlling for levels of critical comments using the Expressed Emotion index . The design required therapists to undertake both forms of treatment and the distinctiveness of the two therapies was ensured by separate supervisors conducting live supervision of the treatments . Measures were undertaken on admission to the study , at 3 months , at 6 months and at the end of treatment . Considerable improvement in nutritional and psychological state occurred across both treatment groups . On global measure of outcome , the two forms of therapy were associated with equivalent end of treatment results . However , for those patients with high levels of maternal criticism towards the patient , the SFT was shown to be superior to the CFT . When individual status measures were explored , there were further differences between the treatments . Symptomatic change was more marked in the SFT whereas there was considerably more psychological change in the CFT group . There were significant changes in family measures of Expressed Emotion . Critical comments between parents and patient were significantly reduced and that between parents was also diminished . Warmth between parents increased",
"OBJECTIVE Adolescents with Anorexia Nervosa ( AN ) , treated with family-based treatment ( FBT ) who fail to gain 2.3 kg by the fourth week of treatment have a 40 - 50 % lower chance of recovery than those who do . Because of the high risk of developing enduring AN , improving outcomes in this group of poor responders is essential . This study examines the feasibility and effects of a novel adaptive treatment ( i.e. , Intensive Parental Coaching-IPC ) aim ed at enhancing parental self-efficacy related to re-feeding skills in poor early responders to FBT . METHOD 45 adolescents ( 12 - 18 years of age ) meeting DSM TR IV criteria for AN were r and omized in an unbalanced design ( 10 to st and ard FBT ; 35 to the adaptive arm ) . Attrition , suitability , expectancy rates , weight change , and psychopathology were compared between groups . OUTCOMES There were no differences in rates of attrition , suitability , expectancy ratings , or most clinical outcomes between r and omized groups . However , the group of poor early responders that received IPC achieved full weight restoration ( > 95 % of expected mean BMI ) by EOT at similar rates as those who had responded early . CONCLUSIONS The results of this study suggest that it is feasible to use an adaptive design to study the treatment effect of IPC for those who do not gain adequate weight by session 4 of FBT . The results also suggest that using IPC for poor early responders significantly improves weight recovery rates to levels comparable to those who respond early . A sufficiently powered study is needed to confirm these promising findings",
"BACKGROUND Little is known about the outcome of involving families in the treatment of adults with anorexia nervosa . Carers of people with anorexia nervosa experience significant levels of distress . This may contribute to unhelpful behaviours which maintain the illness . AIMS To evaluate the effectiveness and acceptability of family workshops with educational and skills-based components as compared to individual family work . METHOD An exploratory r and omised controlled trial of two forms of family intervention was conducted for in patients with anorexia nervosa ( n = 48 ) and their family members on a specialised unit for adults . RESULTS In both groups , there was an improvement in patients ' BMI and a reduction in carers ' distress . There were no differences between groups . CONCLUSION Preliminary findings suggest that workshop-based intervention with two families might be as effective as an individually focused family intervention . This may offer a more cost-effective intervention for this treatment-resistant group",
"OBJECTIVE Few r and omized , controlled trials have examined the efficacy of treatments for anorexia nervosa . Cognitive behavior therapy and interpersonal psychotherapy are effective in a related disorder , bulimia nervosa . There are theoretical and treatment indications for these therapies in anorexia nervosa . METHOD Fifty-six women with anorexia nervosa diagnosed by using strict and lenient weight criteria were r and omly assigned to three treatments . Two were specialized psychotherapies ( cognitive behavior therapy and interpersonal psychotherapy ) , and one was a control treatment combining clinical management and supportive psychotherapy ( nonspecific supportive clinical management ) . Therapy consisted of 20 sessions over a minimum of 20 weeks . RESULTS For the total study group ( intent-to-treat group ) , there were significant differences among therapies in the primary global outcome measure . Nonspecific supportive clinical management was superior to interpersonal psychotherapy , while cognitive behavior therapy was intermediate , neither worse than nonspecific supportive clinical management nor better than interpersonal psychotherapy . For the women completing therapy , nonspecific supportive clinical management was superior to the two specialized therapies . CONCLUSIONS The finding that nonspecific supportive clinical management was superior to more specialized psychotherapies was opposite to the primary hypothesis and challenges assumptions about the effective ingredients of successful treatments for anorexia nervosa",
"BACKGROUND There is a lack of evidence pointing to the efficacy of any specific psychotherapy for adults with anorexia nervosa ( AN ) . The aim of this study was to compare three psychological treatments for AN : Specialist Supportive Clinical Management , Maudsley Model Anorexia Nervosa Treatment for Adults and Enhanced Cognitive Behavioural Therapy . METHOD A multi-centre r and omised controlled trial was conducted with outcomes assessed at pre- , mid- and post-treatment , and 6- and 12-month follow-up by research ers blind to treatment allocation . All analyses were intention-to-treat . One hundred and twenty individuals meeting diagnostic criteria for AN were recruited from outpatient treatment setting s in three Australian cities and offered 25 - 40 sessions over a 10-month period . Primary outcomes were body mass index ( BMI ) and eating disorder psychopathology . Secondary outcomes included depression , anxiety , stress and psychosocial impairment . RESULTS Treatment was completed by 60 % of participants and 52.5 % of the total sample completed 12-month follow-up . Completion rates did not differ between treatments . There were no significant differences between treatments on continuous outcomes ; all result ed in clinical ly significant improvements in BMI , eating disorder psychopathology , general psychopathology and psychosocial impairment that were maintained over follow-up . There were no significant differences between treatments with regard to the achievement of a healthy weight ( mean = 50 % ) or remission ( mean = 28.3 % ) at 12-month follow-up . CONCLUSION The findings add to the evidence base for these three psychological treatments for adults with AN , but the results underscore the need for continued efforts to improve outpatient treatments for this disorder . Trial Registration Australian New Zeal and Clinical Trials Registry ( ACTRN 12611000725965 )",
"Ninety patients with severe anorexia nervosa fulfilling DSM-III-R criteria were assessed in depth in terms of their family developmental psychopathology and then r and omly allocated to either one of three treatment groups or to no treatment . In three treatment regimes , a behavioural approach to diet and weight gain was coupled with individual and family psychotherapy directed at the adolescent maturational problems . All three treatment regimes were highly significantly effective at one year in terms of weight gain , return of menstruation , and aspects of social and sexual adjustment . Body weights above those at pubertal onset were achieved for the group mean maximum and one-year follow-up weights for all three treatment groups but not the control group",
"BACKGROUND Treatment guidelines identify few adequately powered trials to guide recommendations for anorexia nervosa . AIMS To evaluate the effectiveness of three readily available National Health Service treatments for adolescents ( aged 12 - 18 years ) with anorexia nervosa . METHOD Multicentre r and omised controlled trial of 167 young people comparing in-patient , specialist out-patient and general child and adolescent mental health service ( CAMHS ) treatment . RESULTS Each group made considerable progress at 1 year , with further improvement by 2 years . Full recovery rates were poor ( 33 % at 2 years , 27 % still with anorexia nervosa ) . Adherence to in-patient treatment was only 50 % . Neither in-patient nor specialist out-patient therapy demonstrated advantages over general CAMHS treatment by intention to treat , although some CAMHS out- patients were subsequently admitted on clinical grounds . In-patient treatment ( r and omised or after out-patient transfer ) predicted poor outcomes . CONCLUSIONS First-line in-patient psychiatric treatment does not provide advantages over out-patient management . Out-patient treatment failures do very poorly on transfer to in-patient facilities",
"BACKGROUND Psychotherapy is the treatment of choice for patients with anorexia nervosa , although evidence of efficacy is weak . The Anorexia Nervosa Treatment of Out Patients ( ANTOP ) study aim ed to assess the efficacy and safety of two manual-based outpatient treatments for anorexia nervosa -- focal psychodynamic therapy and enhanced cognitive behaviour therapy -- versus optimised treatment as usual . METHODS The ANTOP study is a multicentre , r and omised controlled efficacy trial in adults with anorexia nervosa . We recruited patients from ten university hospitals in Germany . Participants were r and omly allocated to 10 months of treatment with either focal psychodynamic therapy , enhanced cognitive behaviour therapy , or optimised treatment as usual ( including outpatient psychotherapy and structured care from a family doctor ) . The primary outcome was weight gain , measured as increased body-mass index ( BMI ) at the end of treatment . A key secondary outcome was rate of recovery ( based on a combination of weight gain and eating disorder-specific psychopathology ) . Analysis was by intention to treat . This trial is registered at http://is rct n.org , number IS RCT N72809357 . FINDINGS Of 727 adults screened for inclusion , 242 underwent r and omisation : 80 to focal psychodynamic therapy , 80 to enhanced cognitive behaviour therapy , and 82 to optimised treatment as usual . At the end of treatment , 54 patients ( 22 % ) were lost to follow-up , and at 12-month follow-up a total of 73 ( 30 % ) had dropped out . At the end of treatment , BMI had increased in all study groups ( focal psychodynamic therapy 0·73 kg/m(2 ) , enhanced cognitive behaviour therapy 0·93 kg/m(2 ) , optimised treatment as usual 0·69 kg/m(2 ) ) ; no differences were noted between groups ( mean difference between focal psychodynamic therapy and enhanced cognitive behaviour therapy -0·45 , 95 % CI -0·96 to 0·07 ; focal psychodynamic therapy vs optimised treatment as usual -0·14 , -0·68 to 0·39 ; enhanced cognitive behaviour therapy vs optimised treatment as usual -0·30 , -0·22 to 0·83 ) . At 12-month follow-up , the mean gain in BMI had risen further ( 1·64 kg/m(2 ) , 1·30 kg/m(2 ) , and 1·22 kg/m(2 ) , respectively ) , but no differences between groups were recorded ( 0·10 , -0·56 to 0·76 ; 0·25 , -0·45 to 0·95 ; 0·15 , -0·54 to 0·83 , respectively ) . No serious adverse events attributable to weight loss or trial participation were recorded . INTERPRETATION Optimised treatment as usual , combining psychotherapy and structured care from a family doctor , should be regarded as solid baseline treatment for adult out patients with anorexia nervosa . Focal psychodynamic therapy proved advantageous in terms of recovery at 12-month follow-up , and enhanced cognitive behaviour therapy was more effective with respect to speed of weight gain and improvements in eating disorder psychopathology . Long-term outcome data will be helpful to further adapt and improve these novel manual-based treatment approaches . FUNDING German Federal Ministry of Education and Research ( Bundesministerium für Bildung und Forschung , BMBF ) , German Eating Disorders Diagnostic and Treatment Network ( EDNET )",
"OBJECTIVE Inefficient cognitive flexibility is considered a neurocognitive trait marker involved in the development and maintenance of anorexia nervosa ( AN ) . Cognitive Remediation Therapy ( CRT ) is a specific treatment targeting this cognitive style . The aim of this study was to investigate the feasibility and efficacy ( by estimating the effect size ) of specifically tailored CRT for AN , compared to non-specific cognitive training . METHOD A prospect i ve , r and omized controlled , superiority pilot trial was conducted . Forty women with AN receiving treatment as usual ( TAU ) were r and omized to receive either CRT or non-specific neurocognitive therapy ( NNT ) as an add-on . Both conditions comprised 30 sessions of computer-assisted ( 21 sessions ) and face-to-face ( 9 sessions ) training over a 3-week period . CRT focused specifically on cognitive flexibility . NNT was comprised of tasks design ed to improve attention and memory . The primary outcome was performance on a neuropsychological post-treatment assessment of cognitive set-shifting . RESULTS Data available from 25 treatment completers were analyzed . Participants in the CRT condition outperformed participants in the NNT condition in cognitive set-shifting at the end of the treatment ( p = 0.027 ; between-groups effect size d = 0.62 ) . Participants in both conditions showed high treatment acceptance . DISCUSSION This study confirms the feasibility of CRT for AN , and provides a first estimate of the effect size that can be achieved using CRT for AN . Furthermore , the present findings corroborate that neurocognitive training for AN should be tailored to the specific cognitive inefficiencies of this patient group",
"Thirty out- patients with severe anorexia nervosa were r and omly allocated to either 12 sessions of dietary advice or 12 sessions of combined individual and family psychotherapy . At one-year follow-up both groups showed significant overall improvement , and the dietary advice group showed significant weight gain . A similar mean weight gain for the psychotherapy patients did not reach statistical significance , but this group made significant improvements in sexual and social adjustment",
"There is a dearth of literature evaluating day patient treatment for eating disorders based upon the targeted goals of treatment , to conclude that day patient programmes are effective . This study aim ed to explore the effectiveness of an innovative day patient programme by examining whether the seven key treatment goals improved across treatment and were maintained 3 months after discharge . Of the 58 participants who completed measures assessing BMI , eating disorder cognitions , behaviours , core beliefs , readiness to change , quality of life and perpetuating factors at admission , discharge and follow-up , 44 completed the day programme with 14 non-completers . The results demonstrated that all seven treatment goals improved across treatment and the improvements were maintained or further improved at 3 month follow-up . The results are discussed in context of the published day patient programme literature with implication s for future research to maximise optimal treatment outcomes from day patient treatment",
"Abstract Research on the effects of progress feedback and clinician problem-solving tools on patient outcome has been limited to a few clinical problems and setting s ( Shimokawa , Lambert , & Smart , 2010 ) . Although these interventions work well in outpatient setting s their effects so far have not been investigated with eating-disordered patients or in inpatient care . In this study , the effect of providing feedback interventions was investigated in a r and omized clinical trial involving 133 females diagnosed with anorexia nervosa , bulimia nervosa , or eating disorders not otherwise specified . Comparisons were made between the outcomes of patients r and omly assigned to either treatment-as-usual ( TAU ) or an experimental condition ( Fb ) within therapists ( the same therapists provided both treatments ) . Patients in the Fb condition more frequently experienced clinical ly significant change than those who had TAU ( 52.95 % vs. 28.6 % ) . Similar trends were noted within diagnostic groups . In terms of pre to post change in mental health functioning , large effect sizes favored Fb over TAU . Patients ' BMI improved substantially in both TAU and the feedback condition . The effects of feedback were consistent with past research on these approaches although the effect size was smaller in this study . Suggestions for further research are delineated",
"The aim of this study was to compare two forms of outpatient treatment , educational behavioural treatment and cognitive analytical therapy for adult anorexia nervosa . Thirty patients were r and omly allocated to the two treatments . At one year , the group had gained 6.8 kg , 19/30 ( 63 % ) had a good or intermediate recovery in terms of nutritional outcome . The group given cognitive analytical treatment reported significantly greater subjective improvement but there were no differences in other outcome parameters . In conclusion outpatient treatment of adult onset anorexia nervosa leads to an improvement in two thirds of cases . Larger studies will be needed to determine the most effective form of treatment in this group",
"Behavioral family systems therapy ( BFST ) was compared with ego-oriented individual therapy ( EOIT ) in a controlled , r and om-assignment investigation involving 22 young adolescents with anorexia nervosa . Each adolescent and her parents received approximately 16 months of outpatient therapy along with a common medical and dietary regimen . BFST emphasized parental control over eating and weight gain , coupled with cognitive restructuring and problem-solving communication training . EOIT emphasized building ego strength , adolescent autonomy , and insight into the emotional blocks to eating . BFST produced greater change on body-mass index than did EOIT , but both treatments produced comparable improvements on eating attitudes , body shape dissatisfaction , interoceptive awareness , depression/internalizing psychopathology , and eating-related family conflict . The implication s of these results for the clinician who treats adolescents with anorexia nervosa are discussed . J Dev Behav Pediatr 15:111–116 , 1994 . Index terms : anorexia nervosa , adolescents , family therapy , individual therapy",
"Technological advancements allow new approaches to psychotherapy via electronic media . The eating disorder literature currently contains no studies on internet intervention in anorexia nervosa ( AN ) . This study presents a RCT on an internet-based relapse prevention program ( RP ) over nine months after inpatient treatment for AN . The sample comprised 258 women , r and omized to the RP or treatment as usual ( TAU ) . Expert- and self-ratings were evaluated by intent-to-treat analyses . Concerning age , age at onset and comorbidity , both groups were comparable at r and omization . During the RP , the intervention group gained weight while the TAU group had minimal weight loss . RP completers gained significantly more body weight than patients in the TAU condition . Group-by-time comparisons for eating-related cognitions and behaviors and general psychopathology showed a significantly more favorable course in the RP program for \" sexual anxieties \" and \" bulimic symptoms \" ( interview ) , and \" maturity fears \" and \" social insecurity \" ( EDI-2 ) . General psychopathology showed no significant group-by-time interaction . Important factors for successful relapse prevention were adherence to the intervention protocol and increased spontaneity . Considering the unfavorable course and chronicity of anorexia nervosa ( AN ) , internet-based relapse prevention in AN following inpatient treatment appears a promising approach . Future internet-based programs may be further improved and enhanced",
"OBJECTIVE Long-term follow-up studies documenting maintenance of treatment effects are few in adolescent anorexia nervosa ( AN ) . This exploratory study reports relapse from full remission and attainment of remission during a 4-year open follow-up period using a convenience sample of a subgroup of 65 % ( n = 79 ) from an original cohort of 121 participants who completed a r and omized clinical trial comparing family-based therapy ( FBT ) and adolescent-focused individual therapy ( AFT ) . METHOD Follow-up assessment s were completed up to 4 years posttreatment ( average , 3.26 years ) . Available participants completed the Eating Disorder Examination as well as self-report measures of self-esteem and depression at 2 to 4 years posttreatment . RESULTS Two participants ( 6.1 % ) relapsed ( FBT : n = 1 , 4.5 % ; AFT : n = 1 , 9.1 % ) , on average 1.98 years ( SD = 0.14 years ) after remission was achieved at 1-year follow-up . Ten new participants ( 22.7 % ) achieved remission ( FBT : n = 1 , 5.9 % ; AFT : n = 9 , 33.3 % ) . Mean time to remission for this group was 2.01 years ( SD = 0.82 years ) from 1-year follow-up . There were no differences based on treatment group assignment in either relapse from full remission or new remission during long-term follow-up . Other psychopathology was stable over time . CONCLUSION There were few changes in the clinical presentation of participants who were assessed at long-term follow-up . These data suggest that outcomes are generally stable posttreatment regardless of treatment type once remission is achieved . Clinical trial registration information-Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa ; http://www . clinical trials.gov/ ; NCT00149786",
"BACKGROUND This study aims to assess changes in core eating disorder psychopathology ( Eating Attitudes Test , EAT ; Eating Disorders Inventory-2 , EDI-2 ) , depression ( Hamilton Rating Scale , HRSD ; Beck Depression Inventory , BDI ) and general psychopathology ( MMPI-2 ) after inpatient treatment and one-year follow-up among patients diagnosed with anorexia . METHODS Thirty-two patients were treated for anorexia nervosa on an inpatient unit , and were assessed before and after treatment . The inpatient milieu was design ed to use cognitive therapy as the primary therapeutic intervention , along with weight restoration . RESULTS At discharge , all patients displayed significant change in core eating disorder psychopathology in their depressive symptoms , as well as in general aspects of psychopathology . At one-year follow-up , changes in some areas of core eating disorder psychopathology and depressive symptoms continued to be significantly different than from admissions . CONCLUSIONS The combination of CBT and weight restoration can significantly reduce eating disorder symptoms , depression , and general psychopathology during hospitalization , with some sustained benefit over a one year period . Future research is needed to identify the effect of CBT on anorexia nervosa during a wide variety of treatment setting s. Also , research must focus on the influence of outpatient treatment in the outcome of anorexia nervosa",
"OBJECTIVE Findings of a r and omized trial of an identity intervention programme ( IIP ) design ed to build new positive self-schemas that are separate from other conceptions of the self in memory as the means to promote improved health in women diagnosed with eating disorders are reported . METHOD After baseline data collection , women with anorexia nervosa or bulimia nervosa were r and omly assigned to IIP ( n = 34 ) or supportive psychotherapy ( SPI ) ( n = 35 ) and followed at 1 , 6 , and 12 months post-intervention . RESULTS The IIP and supportive psychotherapy were equally effective in reducing eating disorder symptoms at 1 month post-intervention , and changes were stable through the 12-month follow-up period . The IIP tended to be more effective in fostering development of positive self-schemas , and the increase was stable over time . Regardless of baseline level , an increase in the number of positive self-schemas between pre-intervention and 1-month post-intervention predicted a decrease in desire for thinness and an increase in psychological well-being and functional health over the same period . DISCUSSION A cognitive behavioural intervention that focuses on increasing the number of positive self-schemas may be central to improving emotional health in women with anorexia nervosa and bulimia nervosa",
"OBJECTIVE Anorexia nervosa ( AN ) in adults has poor outcomes , and treatment evidence is limited . This study evaluated the efficacy and acceptability of a novel , targeted psychological therapy for AN ( Maudsley Model of Anorexia Nervosa Treatment for Adults ; MANTRA ) compared with Specialist Supportive Clinical Management ( SSCM ) . METHOD One hundred forty-two out patients with broadly defined AN ( body mass index [ BMI ] ≤ 18.5 kg/m² ) were r and omly allocated to receive 20 to 30 weekly sessions ( depending on clinical severity ) plus add-ons ( 4 follow-up sessions , optional sessions with dietician and with carers ) of MANTRA ( n = 72 ) or SSCM ( n = 70 ) . Assessment s were administered blind to treatment condition at baseline , 6 months , and 12 months after r and omization . The primary outcome was BMI at 12 months . Secondary outcomes included eating disorders symptomatology , other psychopathology , neuro-cognitive and social cognition , and acceptability . Additional service utilization was also assessed . Outcomes were analyzed using linear mixed models . RESULTS Both treatments result ed in significant improvements in BMI and reductions in eating disorders symptomatology , distress levels , and clinical impairment over time , with no statistically significant difference between groups at either 6 or 12 months . Improvements in neuro-cognitive and social-cognitive measures over time were less consistent . One SSCM patient died . Compared with SSCM , MANTRA patients rated their treatment as significantly more acceptable and credible at 12 months . There was no significant difference between groups in additional service consumption . CONCLUSIONS Both treatments appear to have value as first-line outpatient interventions for patients with broadly defined AN . Longer term outcomes remain to be evaluated"
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BACKGROUND Musculoskeletal disorders are the most common cause of disability in many industrial countries . Recurrent and chronic pain accounts for a substantial portion of workers ' absenteeism . Neck pain seems to be more prominent in the general population than previously known . OBJECTIVES To determine the effectiveness of workplace interventions ( WIs ) in adult workers with neck pain . SEARCH STRATEGY We search ed : CENTRAL ( The Cochrane Library 2009 , issue 3 ) , and MEDLINE , EMBASE , CINAHL , PsycINFO , ISI Web of Science , OTseeker , PEDro to July 2009 , with no language limitations ; screened reference lists ; and contacted experts in the field . SELECTION CRITERIA We included r and omised controlled trials ( RCT ) , in which at least 50 % of the participants had neck pain at baseline and received interventions conducted at the workplace . DATA COLLECTION AND ANALYSIS Two review authors independently extracted data and assessed risk of bias . Authors were contacted for missing information . Since the interventions varied to a large extend , International Classification of Functioning , Disability and Health ( ICF ) terminology was used to classify the intervention components . This heterogeneity restricted pooling of data to only one meta- analysis of two studies . MAIN RESULTS We identified 1995 references and included10 RCTs ( 2745 workers ) . Two studies were assessed with low risk of bias . Most trials ( N = 8) examined office workers . Few workers were sick-listed . Thus , WIs were seldom design ed to improve return-to-work . Overall , there was low quality evidence that showed no significant differences between WIs and no intervention for pain prevalence or severity . If present , significant results in favour of WIs were not sustained across follow-up times . There was moderate quality evidence ( 1 study , 415 workers ) that a four-component WI was significantly more effective in reducing sick leave in the intermediate-term ( OR 0.56 , 95 % CI 0.33 to 0.95 ) , but not in the short- ( OR 0.83 , 95 % CI 0.52 to 1.34 ) or long-term ( OR 1.28 , 95 % CI 0.73 to 2.26 ) . These findings might be because only a small proportion of the workers were sick-listed . AUTHORS ' CONCLUSIONS Overall , this review found low quality evidence that neither supported nor refuted the benefits of any specific WI for pain relief and moderate quality evidence that a multiple-component intervention reduced sickness absence in the intermediate-term , which was not sustained over time . Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate . There is an urgent need for high quality RCTs with well design ed WIs
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"The total costs for patients who are sick-listed due to back and neck problems have not previously been determined prospect ively on an individual basis . This study aim ed to determine the total cost to a society , based on individually assessed costs of health services and loss of production in people who are sick-listed 28 days or more for back or neck problems . Detailed data on individuals ’ health-care consumption due to back or neck problems was collected through prospect ively entered diaries and question naires , after 4 weeks , 3 months , 1 and 2 years , in a consecutively selected cohort of 1,822 employed persons aged between 18 and 59 years . Costs for health care and production losses due to work absenteeism were determined individually and combined to render total costs to society . The costs for all medical services during the 2-year study were 6.9 % of total costs for back and neck problems . The single most expensive medical service was surgery . Transferred to a national level , annual total costs for back and neck problems corresponded to 1 % of GNP . In conclusion , direct health-service costs were a small fraction of the total costs , consequently indirect costs offer the greatest potential for savings",
"STUDY DESIGN Systematic review and best evidence synthesis . OBJECTIVES To describe the prevalence and incidence of neck pain and disability in workers ; to identify risk factors for neck pain in workers ; to propose an etiological diagram ; and to make recommendations for future research . SUMMARY OF BACKGROUND DATA Previous review s of the etiology of neck pain in workers relied on cross-sectional evidence . Recently published cohorts and r and omized trials warrant a re- analysis of this body of research . METHODS We systematic ally search ed Medline for literature published from 1980 - 2006 . Retrieved articles were review ed for relevance . Relevant articles were critically appraised . Articles judged to have adequate internal validity were included in our best evidence synthesis . RESULTS One hundred and nine papers on the burden and determinants of neck pain in workers were scientifically admissible . The annual prevalence of neck pain varied from 27.1 % in Norway to 47.8 % in Québec , Canada . Each year , between 11 % and 14.1 % of workers were limited in their activities because of neck pain . Risk factors associated with neck pain in workers include age , previous musculoskeletal pain , high quantitative job dem and s , low social support at work , job insecurity , low physical capacity , poor computer workstation design and work posture , sedentary work position , repetitive work and precision work . We found preliminary evidence that gender , occupation , headaches , emotional problems , smoking , poor job satisfaction , awkward work postures , poor physical work environment , and workers ' ethnicity may be associated with neck pain . There is evidence that interventions aim ed at modifying workstations and worker posture are not effective in reducing the incidence of neck pain in workers . CONCLUSION Neck disorders are a significant source of pain and activity limitations in workers . Most neck pain results from complex relationships between individual and workplace risk factors . No prevention strategies have been shown to reduce the incidence of neck pain in workers",
"Study Design . A single‐blinded , r and omized treatment study with a follow‐up period of 6 months . Objective . To study the long‐term consequences of whiplash neck sprain injuries in patients treated with two different regimes during the first 14 days after the car accident . Patients in the first group were encouraged to act as usual , i.e. , continue to engage in their normal , pre‐injury activities ; that group was compared with another group of patients who were given time off from work and who were immobilized using a soft neck collar . The end point of the comparison was the evaluation of subjective symptoms 6 months after the accident . Summary of Background Data . Few r and omized treatment studies have been performed to evaluate the clinical outcome for patients with neck sprain . Method . Patients who participated in the study were recruited from the Emergency Clinic at the University Hospital in Trondheim , Norway . The study group included 201 patients ( 47 % of the study group ) with neck sprain that result ed from a car accident . Neck and shoulder movements and subjective symptoms , which were assessed using several different measurements , were assessed during the follow‐up period . Results . There was a significant reduction of symptoms from the time of intake to 24 weeks after the treatment period in both groups . There was a significantly better outcome for the act‐as‐usual group in terms of subjective symptoms , including pain localization , pain during daily activities , neck stiffness , memory , and concentration , and in terms of visual analog scale measurements of neck pain and headache . Conclusions . The outcome was better for patients who were encouraged to continue engaging in their normal , pre‐injury activities as usual than for patients who took sick leave from work and who were immobilized during the first 14 days after the neck sprain injury",
"Introduction It has been suggested that treatments may be more effective when they are matched to patient characteristics . This study aim ed at investigating potential prognostic factors for clinical ly relevant improvement in symptom intensity and symptom-related disability among employees with symptoms in the neck/shoulder area , receiving either ergonomics counseling or such counseling in combination with myofeedback training . Methods A r and omized controlled study was performed among female computer users aged 45 or older ( n = 36 ) . A clinical examination and a question naire survey were performed before inclusion in the study . Symptom intensity and disability was assessed using question naires before the start of the interventions ( baseline ) and at follow-ups directly after the end of the interventions ( T0 ) and after 3 ( T3 ) and 6 ( T6 ) months . Logistic regression analyses were performed in order to assess prognostic factors for clinical ly relevant improvement in symptom intensity and disability . Results Improvement in symptom intensity was consistently predicted by symptom intensity at baseline . Diagnosis and stress-induced lack of muscular rest were prognostic factors for improvement in symptom intensity at short term follow-up . Baseline disability and passive coping consistently served as prognostic factors for outcome in disability . Few substantial differences were found between the interventions in terms of prognostic factors . Conclusions Myofeedback training in combination with ergonomics counseling seem to be an especially beneficial tool for secondary prevention among employees with moderate levels of symptom intensity and symptom-related disability , who respond to work-related stress by increased/sustained muscle activation , and who tend to employ passive coping to deal with their neck/shoulder symptoms",
"Former studies have question ed the quality and effectiveness of multidisciplinary rehabilitation for working-age adults with fibromyalgia and chronic widespread pain ( CWP ) . High- quality trials are needed , and return to work should also be included as an outcome variable . This r and omized study evaluated the return-to-work outcome of an extensive and a light multidisciplinary treatment program combining cognitive strategies and exercise versus treatment-as-usual initiated by a general practitioner , for CWP patients . The patients ( n=208 ) , on sick leave for 3 months on average , were r and omized to the extensive program including group sessions , a light and more individual program , and to treatment-as-usual . The number of days absent from work and full return to work were used as an outcome , and follow-up lasted 54 months after the programs ended . The regression analysis showed that the extensive program was associated with significantly fewer days absent from work among women . For women , the mean effect of extensive treatment versus treatment-as-usual on total number of days absent from work was estimated to -206.95 days . Among men , the light program was associated with significantly more days absent from work compared to treatment-as-usual . Both among men and women , independent of type of treatment , patients with poorer health ( poor prognosis ) were absent from work more days than patients with good prognosis . In our sample , higher age significantly increased the number of days absent from work , but only for women . The extensive outpatient multidisciplinary treatment program was effective in returning women to work",
"Background : Call centre work with computers is associated with increased rates of upper body pain and musculoskeletal disorders . Methods : This one year , r and omised controlled intervention trial evaluated the effects of a wide forearm support surface and a trackball on upper body pain severity and incident musculoskeletal disorders among 182 call centre operators at a large healthcare company . Participants were r and omised to receive ( 1 ) ergonomics training only , ( 2 ) training plus a trackball , ( 3 ) training plus a forearm support , or ( 4 ) training plus a trackball and forearm support . Outcome measures were weekly pain severity scores and diagnosis of incident musculoskeletal disorder in the upper extremities or the neck/shoulder region based on physical examination performed by a physician blinded to intervention . Analyses using Cox proportional hazard models and linear regression models adjusted for demographic factors , baseline pain levels , and psychosocial job factors . Results : Post-intervention , 63 participants were diagnosed with one or more incident musculoskeletal disorders . Hazard rate ratios showed a protective effect of the armboard for neck/shoulder disorders ( HR = 0.49 , 95 % CI 0.24 to 0.97 ) after adjusting for baseline pain levels and demographic and psychosocial factors . The armboard also significantly reduced neck/shoulder pain ( p = 0.01 ) and right upper extremity pain ( p = 0.002 ) in comparison to the control group . A return-on-investment model predicted a full return of armboard and installation costs within 10.6 months . Conclusion : Providing a large forearm support combined with ergonomic training is an effective intervention to prevent upper body musculoskeletal disorders and reduce upper body pain associated with computer work among call centre employees",
"Background This is a r and omized clinical trial ( RCT ) to investigate the efficacy of a job placement and support program design ed for workers with musculoskeletal injuries and having difficulties in resuming the work role . The program was planned to help injured workers to successfully return to work ( RTW ) by overcoming the difficulties and problems during the process of job seeking and sustaining a job using a case management approach . Methodology A total of 66 injured workers were recruited and r and omly assigned into the job placement and support group ( PS group ) or the self-placement group ( SP group ) . A three-week job placement and support program was given to subjects in the PS group while subjects in the control group ( SP group ) were only given advice on job placement at a workers ’ health center . The PS program was comprised of an individual interview , vocational counseling , job preparation training , and assisted placement using the case management approach . The Chinese Lam Assessment of Stages of Employment Readiness ( C-LASER ) , the Chinese State Trait and Anxiety Inventory ( C-STAI ) , and the SF-36 were the outcome measures for the two groups before and after the training program to observe the changes in subjects ’ work readiness status , emotional status and their health related quality of life pre- and post-training program . The rate of return to work was measured for both groups of subjects after the training program . Results The results indicated that the rate of success in RTW ( 73 % ) was significantly higher in the job placement ( PS ) group than that of the self-placement ( SP ) group ( 51.6 % ) with P C-STAI ( P ( P The job placement ( PS ) program appeared to have enhanced the employability of injured workers . Workers who participated in the program also showed higher levels of work readiness and emotional status in coping with their work injuries",
"The effects of two different prevention programmes on : ( 1 ) reported neck , shoulder and back pain , ( 2 ) perceived physical exertion at work and perceived work-related psychosocial factors , were evaluated by question naires after 12 and 18 months . Female nursing aides and assistant nurses ( n = 282 ) working in the home-care services , were r and omly assigned to one of three groups for : ( 1 ) individually design ed physical training programme , ( 2 ) work-place stress management , ( 3 ) control group . Results revealed no significant differences between the three groups . However , improvements in low back pain were registered within both intervention groups for up to 18 months . Perceived physical exertion at work was reduced in the physical training group . Improvements in neck and shoulder pain did not differ within the three groups . Dissatisfaction with work-related , psychosocial factors was generally increased in all groups . As the aetiology of neck , shoulder and back disorders is multifactorial , a combination of the two intervention programmes might be preferable and should be further studied",
"Background Neck and upper limb symptoms are frequently reported by computer workers . Work style interventions are most commonly used to reduce work-related neck and upper limb symptoms but lifestyle physical activity interventions are becoming more popular to enhance workers health and reduce work-related symptoms . A combined approach targeting work style and lifestyle physical activity seems promising , but little is known on the effectiveness of such combined interventions . Methods / design The RSI@Work study is a r and omised controlled trial that aims to assess the added value of a lifestyle physical activity intervention in addition to a work style intervention to reduce neck and upper limb symptoms in computer workers . Computer workers from seven Dutch companies with frequent or long-term neck and upper limb symptoms in the preceding six months and /or the last two weeks are r and omised into three groups : ( 1 ) work style group , ( 2 ) work style and physical activity group , or ( 3 ) control group . The work style intervention consists of six group meetings in a six month period that take place at the workplace , during work time , and under the supervision of a specially trained counsellor . The goal of this intervention is to stimulate workplace adjustment and to improve body posture , the number and quality of breaks and coping behaviour with regard to high work dem and s. In the combined ( work style and physical activity ) intervention the additional goal is to increase moderate to heavy physical activity . The control group receives usual care . Primary outcome measures are degree of recovery , pain intensity , disability , number of days with neck and upper limb symptoms , and number of months without neck and upper limb symptoms . Outcome measures will be assessed at baseline and six and 12 months after r and omisation . Cost-effectiveness of the group meetings will be assessed using an employer 's perspective . Discussion This study will be one of the first to assess the added value of a lifestyle physical activity intervention in addition to a work style intervention in reducing neck and upper limb symptoms of computer workers . The results of the study are expected in 2007",
"Background Low back pain remains a costly quality -of-life-related health problem . Microdiscectomy is often the surgical procedure of choice for a symptomatic , single-level , lumbar disc herniation in younger and middle-aged adults . The question of whether a post-microdiscectomy exercise program enhances function , quality of life , and disability status has not been systematic ally explored . Thus , the overall purpose of this study is to assess immediate and long-term outcomes of an exercise program , developed at University of Southern California ( USC ) , targeting the trunk and lower extremities ( USC Spine Exercise Program ) for persons who have undergone a single-level microdiscectomy for the first time . Methods / design One hundred individuals between the ages of 18 and 60 who consent to undergo lumbar microdiscectomy will be recruited to participate in this study . Subjects will be r and omly assigned to one of two groups : 1 ) one session of back care education , or 2 ) a back care education session followed by the 12-week USC Spine Exercise Program . The outcome examiners ( evaluators ) , as well as the data managers , will be blinded to group allocation . Education will consist of a one-hour \" one-on-one \" session with the intervention therapist , guided by an educational booklet specifically design ed for post-microdiscectomy care . This session will occur four to six weeks after surgery . The USC Spine Exercise Program consists of two parts : back extensor strength and endurance , and mat and upright therapeutic exercises . This exercise program is goal -oriented , performance-based , and periodized . It will begin two to three days after the education session , and will occur three times a week for 12 weeks . Primary outcome measures include the Oswestry Disability Question naire , Rol and -Morris Disability Question naire , SF-36 ® quality of life assessment , Subjective Quality of Life Scale , 50-foot Walk , Repeated Sit-to-St and , and a modified Sorensen test . The outcome measures in the study will be assessed before and after the 12-week post-surgical intervention program . Long-term follow up assessment s will occur every six months beginning one year after surgery and ending five years after surgery . Immediate and long-term effects will be assessed using repeated measures multivariate analysis of variance ( MANOVA ) . If significant interactions are found , one-way ANOVAs will be performed followed by post-hoc testing to determine statistically significant pairwise comparisons . Discussion We have presented the rationale and design for a r and omized controlled trial evaluating the effectiveness of a treatment regimen for people who have undergone a single-level lumbar microdiscectomy",
"Background Persisting neck pain is common in society . It has been reported that the prevalence of neck pain in office workers is much higher than in the general population . The costs to the worker , employer and society associated with work-related neck pain are known to be considerable and are escalating . The factors that place office workers at greater risk of developing neck pain are not understood . The aim of this study is to investigate the incidence and risk factors of work-related neck pain in Australian office workers . Methods / design We will conduct a prospect i ve cohort study . A cohort of office workers without neck pain will be followed over a 12 month period , after baseline measurement of potential risk factors . The categories of risk factors being evaluated are physical ( cervical spine posture , range of movement , muscle endurance and exercise frequency ) , demographic ( age , sex ) , work environment ( sitting duration , frequency of breaks ) and psychosocial ( psychological distress and psychosocial work factors ) . Cox regression analysis will be used to identify risk factors associated with work-related neck pain , and will be expressed as hazard ratios with 95 % confidence intervals . The data will also enable the incidence of neck pain in this population to be estimated . Discussion In addition to clarifying the magnitude of this occupational health problem these data could inform policy in workplaces and provide the basis for primary prevention of neck pain in office workers , targeting the identified risk factors",
"Objective : To investigate the effects of ambulant myofeedback training including ergonomic counselling ( Mfb ) and ergonomic counselling alone ( EC ) , on work-related neck-shoulder pain and disability . Methods : Seventy-nine female computer workers reporting neck-shoulder complaints were r and omly assigned to Mfb or EC and received four weeks of intervention . Pain intensity in neck , shoulders , and upper back , and pain disability , were measured at baseline , immediately after intervention , and at three and six months follow-up . Results : Pain intensity and disability had significantly decreased immediately after four weeks Mfb or EC , and the effects remained at follow up . No differences were observed between the Mfb and EC group for outcome and subjects in both intervention groups showed comparable chances for improvement in pain intensity and disability . Conclusions : Pain intensity and disability significantly reduced after both interventions and this effect remained at follow-up . No differences were observed between the two intervention groups",
"OBJECTIVES This study evaluated the effects on work-related neck and upper-limb disorders among computer workers stimulated ( by a software program ) to take regular breaks and perform physical exercises . Possible effects on sick leave and productivity were studied as well . A r and omized controlled design was used with cluster r and omization . Altogether 268 computer workers with complaints in the neck or an upper limb from 22 office locations were r and omized into a control group , one intervention group stimulated to take extra breaks and one intervention group stimulated to perform exercises during the extra breaks during an 8-weekperiod . Question naires were administered before and after the intervention , and questions were generated by the software during the intervention period . Computer usage was recorded online . RESULTS The data on self-reported recovery suggested a favorable effect ; more subjects in the intervention groups than in the control group reported recovery ( 55 % versus 34 % ) from their complaints and fewer reported deterioration ( 4 % versus 20 % ) . However , a comparison between the reported pre- and postintervention scores on the severity and frequency of the complaints showed no significant differences in the change among the three groups . No effects on sick leave were observed . The subjects in the intervention groups showed higher productivity . CONCLUSIONS The use of a software program stimulating workers to take regular breaks contributes to perceived recovery from neck or upper-limb complaints . There seems to be no additional effects from performing physical exercises during these breaks",
"Objective To evaluate the cost effectiveness , cost utility , and cost-benefit of an integrated care programme compared with usual care for sick listed patients with chronic low back pain . Design Economic evaluation alongside a r and omised controlled trial with 12 months ’ follow-up . Setting Primary care ( 10 physiotherapy practice s , one occupational health service , one occupational therapy practice ) and secondary care ( five hospitals ) in the Netherl and s , 2005 - 9 . Participants 134 adults aged 18 - 65 sick listed because of chronic low back pain : 66 were r and omised to integrated care and 68 to usual care . Interventions Integrated care consisted of a workplace intervention based on participatory ergonomics , with involvement of a supervisor , and a grade d activity programme based on cognitive behavioural principles . Usual care was provided by general practitioners and occupational physicians according to Dutch guidelines . Main outcome measures The primary outcome was duration until sustainable return to work . The secondary outcome was quality adjusted life years ( QALYs ) , measured using EuroQol . Results Total costs in the integrated care group ( £ 13 165 , SD £ 13 600 ) were significantly lower than in the usual care group ( £ 18 475 , SD £ 13 616 ) . Cost effectiveness planes and acceptability curves showed that integrated care was cost effective compared with usual care for return to work and QALYs gained . The cost-benefit analyses showed that every £ 1 invested in integrated care would return an estimated £ 26 . The net societal benefit of integrated care compared with usual care was £ 5744 . Conclusions Implementation of an integrated care programme for patients sick listed with chronic low back pain has a large potential to significantly reduce societal costs , increase effectiveness of care , improve quality of life , and improve function on a broad scale . Integrated care therefore has large gains for patients and society as well as for employers",
"Introduction The goal of this study was to assess the effectiveness of a group-based interactive work style intervention in improving work style behavior . Methods Computer workers with neck and upper limb symptoms were r and omised into the work style group ( WS , N = 152 ) , the work style and physical activity group ( WSPA , N = 156 ) , or the usual care group ( N = 158 ) . Both intervention groups received the same work style intervention but the WSPA group also received a lifestyle physical activity intervention . Participants from the intervention groups attended six group meetings which focused on behavioral change with regard to body posture and workstation adjustment , breaks , and coping with high work dem and s in order to reduce work stress . Stage of change , breaks and exercise behavior , and stress outcomes were assessed by question naire at baseline ( T0 ) and after 6 ( T1 ) and 12 months ( T2 ) . Body posture and workstation adjustment were assessed by observation and by question naire at T0 , T1 , and T2 . Multilevel analyses were used to study differences in work style behavior between study groups . Results The work style intervention was effective in improving stage of change with regard to body posture , workstation adjustment , and the use of sufficient breaks during computer work . These findings were confirmed by higher self-reported use of breaks and exercise reminder software and less working hours without breaks . However , self-reported changes in body posture and workstation adjustment were less consistent . The work style intervention was ineffective in changing stress outcomes . Conclusion A group-based work style intervention seems to be effective in improving some elements of work style behavior . Future studies should investigate the effectiveness of work style interventions on all dimensions of the Feuerstein work style model",
"Abstract This study assessed the effectiveness of a single intervention targeting work style and a combined intervention targeting work style and physical activity on the recovery from neck and upper limb symptoms . Computer workers with frequent or long‐term neck and upper limb symptoms were r and omised into the work style group ( WS , n = 152 ) , work style and physical activity group ( WSPA , n = 156 ) , or usual care group ( n = 158 ) . The WS and WSPA group attended six group meetings . All meetings focused on behavioural change with regard to body posture , workplace adjustment , breaks and coping with high work dem and s ( WS and WSPA group ) and physical activity ( WSPA group ) . Pain , disability at work , days with symptoms and months without symptoms were measured at baseline and after 6 ( T1 ) and 12 months ( T2 ) . Self‐reported recovery was assessed at T1/T2 . Both interventions were ineffective in improving recovery . The work style intervention but not the combined intervention was effective in reducing all pain measures . These effects were present in the neck/shoulder , not in the arm/wrist/h and . For the neck/shoulder , the work style intervention group also showed an increased recovery‐rate . Total physical activity increased in all study groups but no differences between groups were observed . To conclude , a group‐based work style intervention focused on behavioural change was effective in improving recovery from neck/shoulder symptoms and reducing pain on the long‐term . The combined intervention was ineffective in increasing total physical activity . Therefore we can not draw conclusions on the effect of increasing physical activity on the recovery from neck and upper limb symptoms",
"The aim of this study was to determine the effect of a tactile feedback signal on hovering behaviour , productivity , usability and comfort after 1 week of using an experimental mouse . In a r and omized controlled trial , a regular computer mouse was compared to a new developed mouse with a tactile , vibrating feedback signal to prevent unnecessary hovering above the computer mouse . According to this study , participants do decrease their hovering behaviour when using a mouse with tactile feedback . Furthermore , the mouse with tactile feedback did not influence productivity . Usability was rated somewhat mixed . The use of a mouse with a tactile vibrating feedback signal seems promising for preventing neck , shoulder and arm complaints . Further research is needed to study long-term effects on ( prevention of ) neck , shoulder and arm complaints and development of learning effects",
"Study Design . A 3-year prospect i ve cohort study among 1334 workers was conducted . Objective . To determine whether the work-related psychosocial factors of quantitative job dem and s , conflicting job dem and s , skill discretion , decision authority , supervisor support , coworker support , and job security are risk factors for neck pain . Summary of Background Data . Among the various risk factors for neck pain , work-related psychosocial factors play a major role . Previous studies on risk factors for neck pain often had a cross-sectional design , and did not take both physical and psychosocial factors into account . Methods . At baseline , data on work-related psychosocial factors were collected by means of a question naire . During the 3-year follow-up period , data on the occurrence of neck pain were collected by means of postal question naires . Individuals without neck pain at baseline were selected for the analyses . Cox regression analysis was applied to examine the relation between the work-related psychosocial factors and the cumulative incidence of neck pain . Adjustments were made for various physical factors and individual characteristics . Results . The analysis included 977 patients . Altogether , 141 workers ( 14.4 % ) reported that they had experienced neck pain at least once during the 3-year follow-up period . The relation of neck pain to high quantitative job dem and s ( relative risk [ RR ] , 2.14 ; 95 % confidence interval [ CI ] , 1.28–3.58 ) and low coworker support ( RR , 2.43 ; 95 % CI , 1.11–5.29 ) was statistically significant . An increased risk was found for low decision authority in relation to neck pain ( RR , 1.60 ; 95 % CI , 0.74–3.45 ) , but this relation was not statistically significant . Conclusions . High quantitative job dem and s and low coworker support are independent risk factors for neck pain . There are indications that another risk factor for neck pain is low decision authority",
"Using a computer keyboard with the forearms unsupported has been proposed as a causal factor for neck/shoulder and arm/h and diagnoses . Recent laboratory and field studies have demonstrated that forearm support might be preferable to working in the traditional \" floating \" posture . The aim of this study was to determine whether providing forearm support when using a normal computer workstation would decrease musculoskeletal discomfort in intensive computer users in a call centre . A r and omised controlled study ( n = 59 ) , of 6 weeks duration was conducted . Thirty participants ( Group 1 ) were allocated to forearm support using the desk surface with the remainder ( Group 2 ) acting as a control group . At 6 weeks , the control group was also set up with forearm support . Both groups were then monitored for another 6 weeks . Question naires were used at 1 , 6 and 12 weeks to obtain information about discomfort , workstation setup , working posture and comfort . Nine participants ( Group 1 n = 6 , Group 2 n = 3 ) withdrew within a week of commencing forearm support either due to discomfort or difficulty in maintaining the posture . At 6 weeks , the group using forearm support generated significantly fewer reports of discomfort in the neck and back , although the difference between the groups was not statistically significant . At 12 weeks , there were fewer reports of neck , back and wrist discomfort when preintervention discomfort was compared with post intervention discomfort . These findings indicate that for the majority of users , forearm support may be preferable to the \" floating \" posture implicit in current guidelines for computer workstation setup",
"The purpose of this study was to describe , and analyse the effect of an intervention on , the biomechanical workload in the neck and shoulder region of female hairdressers . Arm elevation was measured by inclinometers and muscular load of m. trapezius by electromyography . The intervention comprised working technique recommendations , e.g. to work with less elevated arms and more relaxed muscles . The subjects were r and omised between two different intensity levels of the intervention , one with written information only and the other with additional personal follow-up . The effect of the intervention was evaluated after 1 - 2 months . The hairdressers worked with their arms elevated 60 degrees or more for approximately 13 % of the total working time and 16 % during the specific hairdressing tasks . The intervention group including personal follow-up instructions had a reduction in workload from 4.0 % to 2.5 % of hairdressing time with highly elevated right upper arm , i.e. above 90 degrees . No effect was detected on muscular load or neck and shoulder symptoms after the intervention",
"Computer operators at two work sites ( n = 73 , n = 19 ) were prompted to take three 30-s and one 3-min break from computer work each hour in addition to conventional rest breaks . Some operators were asked to perform stretching exercises during the short breaks . Mood state and musculoskeletal discomfort were assessed at each work site over a 2- or 3-week baseline period and a 4- or 6-week treatment period , respectively . Operator productivity measures were obtained from company records . Operators complied with about half of the added breaks but favoured 3-min breaks over 30-s breaks . No improvement in productivity or well-being was found at the larger work site . At the smaller work site , productivity , eye , leg and foot comfort all improved when the short breaks included stretching exercises . These results provide evidence that frequent short breaks from continuous computer-mediated work can benefit worker productivity and well-being when the breaks integrate with task dem and",
"Objectives : To examine the efficacy of a participatory ergonomics intervention in preventing musculoskeletal disorders among kitchen workers . Participatory ergonomics is commonly recommended to reduce musculoskeletal disorders , but evidence for its effectiveness is sparse . Methods : A cluster r and omised controlled trial among the 504 workers of 119 kitchens in Finl and was conducted during 2002–2005 . Kitchens were r and omised to an intervention ( n = 59 ) and control ( n = 60 ) group . The duration of the intervention that guided the workers to identify strenuous work tasks and to seek solutions for decreasing physical and mental workload , was 11 to 14 months . In total , 402 ergonomic changes were implemented . The main outcome measures were the occurrence of and trouble caused by musculoskeletal pain in seven anatomical sites , local fatigue after work , and sick leave due to musculoskeletal disorders . Individual level data were collected by a question naire at baseline and every 3 months during the intervention and 1-year follow-up period . All response rates exceeded 92 % . Results : No systematic differences in any outcome variable were found between the intervention and control groups during the intervention or during the 1-year follow-up . Conclusions : The intervention did not reduce perceived physical work load and no evidence was found for the efficacy of the intervention in preventing musculoskeletal disorders among kitchen workers . It may be that a more comprehensive re design of work organisation and processes is needed , taking more account of workers ’ physical and mental re sources",
"Objective : To determine the effectiveness and cost-effectiveness of a return-to-work outpatient multidisciplinary treatment programme for sick-listed workers with non-specific upper extremity musculoskeletal complaints . Methods : A r and omized controlled trial with a 1-year follow-up was carried out . Thirty-eight subjects were allocated to multidisciplinary treatment ( intervention , n=23 ) , or to usual care provided by occupational health services ( n=15 ) . The intervention consisted of psychological and physical sessions provided by a medical specialist , a psychologist , a physiotherapist and an occupational therapist . It aims at reconditioning , “ de-medicalizing ” , unrestrained moving and return-to-work . The intervention process was evaluated on compliance to the protocol and the effectiveness of its components . The individual outcome variable was the severity of complaints . The societal outcomes included return-to-work and costs . Measurements were performed at baseline and after 2 , 6 and 12 months . Mixed model analyses were used for analysis . Results : The intervention achieves its aims : physical disabilities ( P=0.039 ) , kinesiophobia ( P physical functioning ( P=0.016 ) improved significantly as compared to usual care . In addition , the intervention was significantly more effective in reducing the severity of complaints than usual care . The intervention was equally effective compared to usual care in terms of return-to-work ( 86 % in the intervention group vs. 73 % in the usual care group ) . The extra total costs and the extra gains in terms of return-to-work were not significantly higher for the intervention as compared to usual care after 12 months . Conclusion : Multidisciplinary treatment affects individuals positively , but shows no significant difference in ( cost- ) effectiveness on the societal level as compared to usual care",
"OBJECTIVES This study evaluated the effect of an ergonomic training program on workstation changes and on the prevalence of musculoskeletal disorders among video display unit ( VDU ) users at a large university . METHODS A pretest-posttest design with a reference group was used with r and om allocation of administrative and geographic units . In each group , the measurements involved direct observation of the workstations , a self-administered question naire , and a physical examination . The measurements were performed 2 weeks before and 6 months after the training in parallel in both groups . The study population was composed of 627 workers ( 81 % of those eligible ) . RESULTS The prevalence of all 3 of the postural stressors evaluated decreased in the experimental group after the training . In the reference group , 2 of the 3 stressors decreased in frequency but to a less extent . Some of these beneficial changes were more frequent in workers under 40 years of age . The prevalence of musculoskeletal disorders decreased among the workers under 40 years of age in the experimental group , from 29 % to 13 % determined by question naire and from 19 % to 3 % determined by physical examination . In other groups , there was no significant change in the prevalence of musculoskeletal disorders . CONCLUSIONS Improvements in postural stressors occurred more frequently in the experimental group , and these beneficial changes tended to be more frequent in workers under 40 years of age . Improvements in musculoskeletal disorders occurred in the experimental group among the workers under 40 years of age",
"& NA ; The aim of the present study was to evaluate the long‐term outcome of a behavioural medicine rehabilitation programme and the outcome of its two main components , compared to a ‘ treatment‐as‐usual ’ control group . The study employed a 4 × 5 repeated‐ measures design with four groups and five assessment periods during a 3‐year follow‐up . The group studied consisted of blue‐collar and service/care workers on sick leave , identified in a nationwide health insurance scheme in Sweden . After inclusion , the subjects were r and omised to one of the four conditions : behaviour‐oriented physiotherapy ( PT ) , cognitive behavioural therapy ( CBT ) , behavioural medicine rehabilitation consisting of PT+CBT ( BM ) and a ‘ treatment‐as‐usual ’ control group ( CG ) . Outcome variables were sick leave , early retirement and health‐related quality of life . A cost‐effectiveness analysis , comparing the programmes , was made . The results showed , consistently , the full‐time behavioural medicine programme being superior to the three other conditions . The strongest effect was found on females . Regarding sick leave , the mean difference in the per‐ protocol analysis between the BM programme and the control group was 201 days , thus reducing sick leave by about two‐thirds of a working year . Rehabilitating women has a substantial impact on costs for production losses , whereas rehabilitating men seem to be effortless with no significant effect on either health or costs . In conclusion , a full‐time behavioural medicine programme is a cost‐effective method for improving health and increasing return to work in women working in blue‐collar or service/care occupations and suffering from back/neck pain",
"Study Design . A population cohort study to determine the 1-year persistence of neck pain . Objectives . The aim of this study was to determine the persistence of neck pain over a 12-month period among the general adult population and to explore socio-demographic , health-related , occupational , physical , and lifestyle factors that might be linked to such persistence . Summary of Background Data . Musculoskeletal clinicians report that neck patients frequently return to consult for recurring episodes of pain . However , the persistent nature of neck pain has been less research ed than other common chronic pain syndromes . Methods . First , to identify a cohort of current neck pain sufferers , a baseline cross-sectional survey was conducted in a general population of 7,669 adults , 18 to 75 years of age , registered with two primary care practice s in South Manchester , UK . The second phase was a follow-up survey , 12 months later , to determine the 1-year persistence of neck pain among those who had reported neck pain at baseline . Persistence of neck pain was compared across groups of responders stratified by potential prognostic factors measured at baseline . “ Persistent ” neck pain was defined according to shading within the region of the neck on a blank body mannequin . The term “ persistent ” neck pain could therefore reflect chronic , recurrent , or continuous pain . Results . There were 1,359 neck pain responders in the baseline survey , and these subjects formed the study population for the prospect i ve study . At follow-up , 786 ( 58 % ) subjects responded , of whom 48 % reported having neck pain lasting for more than 1 day , during the previous month . Significant baseline characteristics , which independently predicted persistent neck pain , were age ( odds ratio [ OR ] = 3.4 ) , being off work at the time of the baseline survey ( OR = 1.6 ) , comorbid low back pain ( OR = 1.6 ) , and cycling as a regular activity ( OR = 2.4 ) . Conclusion . Among the general population , neck pain persists at 12 months in around half of those who report neck pain at the start of the period . An increased risk of persistent neck pain was associated with age 45 to 59 years and low back pain , and also with cycling . The linkwith psychological distress and the absence of a link with occupational factors compares with other previous findings for common musculoskeletal syndromes in the community",
"& NA ; In general , r and omized controlled studies concerning return to work have failed to demonstrate significant treatment effects for long‐lasting musculoskeletal pain , and most treatments examined have not been economically beneficial . Individuals ( n=654 ) sick‐listed for at least 8 weeks with musculoskeletal pain , selected from the Norwegian m and atory sickness insurance system and volunteering to participate , were categorized into three groups differing in a prognosis score ( good , medium , poor ) for return to work , based on a brief , st and ardized screening of psychological and physiotherapy findings . They were then r and omly assigned to three outpatient treatments with three different levels of intensity ( ordinary treatment , light multidisciplinary , and extensive multidisciplinary treatment ) . The evaluation was based on 14 months follow‐up data on return to work collected from social security records . The patients with good prognosis for return to work do equally well with ordinary treatment as with the two more intensive treatments . The patients with medium prognosis benefit equally from the two multidisciplinary treatments . The patients with poor prognosis receiving extensive multidisciplinary treatment returned to work at a higher rate than patients with poor prognosis receiving ordinary treatment , 55 vs. 37 % ( P . Multidisciplinary treatment is effective concerning return to work , when given to patients who are most likely to benefit from that treatment . Measures of pain or quality of life are not included in this study . The cost – benefit analysis of the economic returns of the light multidisciplinary and the extensive multidisciplinary treatment programs yields a positive net present social value of the treatment . A simple , st and ardized , screening instrument including only psychological and physiotherapeutic observations may be a useful clinical tool for allocating patients with musculoskeletal pain to the right level of treatment",
"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",
"Objectives : To identify risk factors for new episodes of sick leave due to neck or back pain . Methods : This prospect i ve study comprised an industrial population of 2187 employees who were followed up at 18 months and 3 years after a comprehensive baseline measurement . The potential risk factors comprised physical and psychosocial work factors , health-related and pain-related characteristics and lifestyle and demographic factors . The response rate at both follow-ups was close to 73 % . Results : At the 18-month follow-up , 151 participants reported at least one episode of sick-listing due to neck or back pain during the previous year . Risk factors assessed at baseline for sick leave due to neck or back pain at the follow-up were blue-collar work , back pain one or several times during the previous year , 1–99 days of cumulative sickness absence during the previous year ( all causes except neck or back pain ) , uncertainty of one ’s own working ability in 2 years ’ time and the experience of few positive challenges at work . After 3 years , 127 participants reported at least one episode of sick leave due to back or neck pain during the year previous to follow-up . The risk factors for this pain-related sick leave were blue-collar work , several earlier episodes of neck pain , no everyday physical activities during leisure time ( cleaning , gardening and so on ) , lower physical functioning and , for blue-collar workers separately , repetitive work procedures . Conclusion : The most consistent risk factors for new episodes of sick leave due to neck or back pain found during both the follow-ups were blue-collar work and several earlier episodes of neck or back pain assessed at baseline . Preventive efforts to decrease sick leave due to neck or back pain may include measures to increase the occurrence of positive challenges at work and to minimise repetitive work procedures . An evidence -based secondary prevention of neck and back pain including advice to stay active is also warranted",
"We evaluated a participatory ergonomic intervention process applied in 59 municipal kitchens . In groups of three to five kitchens , the workers participated in eight workshops , and generated and evaluated solutions to optimize musculoskeletal load in their work . An ergonomist initiated and supported the process . By the end , 402 changes were implemented . Evaluative data were collected using research diaries , question naires , and focus group interviews . The intervention model proved feasible and the participatory approach was mostly experienced as motivating . The workers ' knowledge and awareness of ergonomics increased , which improved their ability to tackle ergonomic problems by themselves . The changes in ergonomics were perceived to decrease physical load and improve musculoskeletal health . As hindering factors for implementation , lack of time and motivation , and insufficient financial re sources were mentioned . In addition , the workers expressed a wish for more support from the management , technical staff , and ergonomists",
"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 : The present study sought to determine whether job insecurity is associated with personality traits and beliefs . In addition , it was tested whether aspects of personality confounded the relationships between job insecurity and health , or moderated this association . Methods : At the first data collection , 5163 persons participated , and at the second data collection , 1946 persons of a r and om sample participated . Data were obtained from Oslo Health Study . Results : The job insecurity aspect concerning confidence in having a good job in 2 years was more strongly related to the health variables , and particularly with mental distress , compared with other aspects of job insecurity . Type-A behavior predicted an increase in upper back pain ( & bgr ; 0.07 ) , while optimism predicted a change in lower back pain ( & bgr ; −0.07 ) . Conclusions : Job insecurity is associated with health ; this association is strongest for mental distress and self-reported health , and weaker for back-pain",
"OBJECTIVE The purpose of this study was to evaluate the effectiveness of an active ergonomics training ( AET ) program in computer users . Two constructs from the social-cognitive theory were adopted to provide a more comprehensive assessment of the proximal markers of behavior change . METHOD Eighty-seven symptomatic and asymptomatic employees who worked at a computer for a minimum of 10 hours per week took part in a prospect i ve r and omized controlled study . Subjects participated in a six-hour training intervention at their workplace . Key elements of the AET intervention were skill development in workstation analysis , active participation , and implementation of multiple prevention strategies . RESULTS After receiving AET , risk factor exposure was significantly reduced for participants at higher risk [ F(1,82 ) = 6.42 , p knowledge [ F(1,74 ) = 8.39 , p self-efficacy [ F(1,73 ) = 6.95 , p outcome expectations [ F(1,75 ) = 8.75 , p AET intervention had significantly less upper back pain intensity ( z = -2.03 , p pain frequency ( z = -2.70 , p pain duration ( z = -3.25 , p work postures , work practice s , risk factor exposure , and pain",
"OBJECTIVES This study evaluated the effect of an intensive ergonomic approach and education on workstation changes and musculoskeletal disorders among workers who used a video display unit ( VDU ) . METHODS A r and omized controlled design was used . The subjects ( N=124 ) were allocated into three groups ( intensive ergonomics , ergonomic education , reference ) using stratified r and om sampling . The evaluation involved question naires , a diary of discomfort , measurements of workload , and an ergonomic rating of the workstations . The assessment s were made 2 weeks before the intervention and after 2 and 10 months of follow-up . RESULTS The intensive and training groups showed less musculoskeletal discomfort than the reference group after 2 months of follow-up . Positive effects on discomfort were seen primarily for the shoulder , neck , and upper back areas . No significant differences were found for the strain levels or prevalence of pain . After the intervention the ergonomic level was distinctly higher in the intensive ergonomic group than in the education or reference group . CONCLUSIONS Both the intensive ergonomics approach and education in ergonomics help reduce discomfort in VDU work . In attempts to improve the physical ergonomics of VDU workstations , the best result will be achieved with cooperative planning in which both workers and practitioners are actively involved",
"The effects of a downward-tilting ( DT ) keyboard tray on wrist posture , seated posture and self-assessed musculoskeletal discomfort were investigated in a field experiment . Thirty-eight professional office workers were studied . A pretest assessed how they typed using either a conventional keyboard on a desk or on an articulating keyboard tray , and with or without wrist rests . Workers were r and omly allocated to a control ( n = 15 ) or test group ( n = 23 ) that used their existing keyboard in a DT system . A post-test was conducted 3 weeks later . Results showed no significant changes in wrist posture , seated posture or reports of musculoskeletal discomfort for the control group , and approximately 50 % of typing wrist movements put the h and in a neutral zone . There were significant improvements in wrist posture , seated posture and upper body musculoskeletal discomfort for the test group using the DT system . Over 80 % of typing wrist movements put the h and into a neutral zone with the DT arrangement . Reactions to using a conventional keyboard on a DT system were positive",
"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",
"Introduction In Denmark , the magnitude and impact of work disability on the individual worker and society has prompted the development of a new “ coordinated and tailored work rehabilitation ” ( CTWR ) approach . The aim of this study was to compare the effects of CTWR with conventional case management ( CCM ) on return-to-work of workers on sick leave due to musculoskeletal disorders ( MSDs ) . Methods The study was a r and omized controlled trial with economic evaluation undertaken with workers on sick leave for 4–12 weeks due to MSDs . CTWR consists of a work disability screening by an interdisciplinary team followed by the collaborative development of a RTW plan . The primary outcome variable was registered cumulative sickness absence hours during 12 months follow-up . Secondary outcomes were work status as well as pain intensity and functional disability , measured at baseline , 3 and 12 months follow-up . The economic evaluation ( intervention costs , productivity loss , and health care utilization costs ) was based on administrative data derived from national registries . Results For the time intervals 0–6 months , 6–12 months , and the entire follow-up period , the number of sickness absence hours was significantly lower in the CTWR group as compared to the control group . The total costs saved in CTWR participants compared to controls were estimated at US $ 1,366 per person at 6 months follow-up and US $ 10,666 per person at 12 months follow-up . Conclusions Workers on sick leave for 4–12 weeks due to MSD who underwent “ CTWR ” by an interdisciplinary team had fewer sickness absence hours than controls . The economic evaluation showed that — in terms of productivity loss — CTWR seems to be cost saving for the society",
"This paper review s the ergonomic and psychosocial factors that affect musculoskeletal disorders at the workstation . First is a model of a physiological assessment protocol that incorporated SEMG monitoring while working at the computer . Next is a study that showed that participants lack awareness of their muscle tension as compared to the actual SEMG levels . The final study illustrated how an intervention program can reduce RSI symptoms , decrease respiration rate , and lower SEMG activity . Recommendations include suggestions that successful safety and prevention programs need multiple components and that participants should to be trained to control physiological responses with respiration and SEMG biofeedback . All participants should master these physiological skills just as they learn how to use the computer",
"The effect of \" neck school \" on neck and shoulder disorders was studied in medical secretaries . A neck school reinforced with compliance enhancing measures ( group B ) was compared with a traditional neck school ( group A ) and a control group ( group C ) . The results show that ergonomical knowledge was good even before the secretaries attended the neck schools and that compliance was significantly higher for group B. When comparisons were made within groups some improvements on neck and shoulder fatigue and pain were noted , particularly for group B. When workload was controlled no significant group differences were found . No differences were noted for range of neck motion , or sick leave in any group . Our conclusion is that neck schools , despite good compliance , appear to be of limited clinical value for prevention of neck and shoulder disorders"
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BACKGROUND The introduction of enteral feeds for very preterm ( less than 32 weeks ' gestation ) or very low birth weight ( VLBW ; less than 1500 g ) infants is often delayed for several days or longer after birth due to concern that early introduction may not be tolerated and may increase the risk of necrotising enterocolitis ( NEC ) . However , delaying enteral feeding could diminish the functional adaptation of the gastrointestinal tract and prolong the need for parenteral nutrition with its attendant infectious and metabolic risks . OBJECTIVES To determine the effect of delayed introduction of progressive enteral feeds on the incidence of NEC , mortality and other morbidities in very preterm or VLBW infants . SEARCH METHODS We search ed the Cochrane Central Register of Controlled Trials ( CENTRAL , 2014 , Issue 8) , MEDLINE ( 1966 to September 2014 ) , EMBASE ( 1980 to September 2014 ) , CINAHL ( 1982 to September 2014 ) , conference proceedings and previous review s. SELECTION CRITERIA We included r and omised or quasi-r and omised controlled trials that assessed the effect of delayed ( more than four days after birth ) versus earlier introduction of progressive enteral feeds on the incidence of NEC , mortality and other morbidities in very preterm or VLBW infants . DATA COLLECTION AND ANALYSIS Two review authors independently assessed trial eligibility and risk of bias and undertook data extraction . We analysed the treatment effects in the individual trials and reported the risk ratio ( RR ) and risk difference for dichotomous data and mean difference for continuous data , with respective 95 % confidence intervals ( CI ) . We used a fixed-effect model in meta-analyses and explored the potential causes of heterogeneity in sensitivity analyses . MAIN RESULTS We identified nine r and omised controlled trials in which 1106 infants participated . Few participants were extremely preterm ( less 28 weeks ' gestation ) or extremely low birth weight ( less than 1000 g ) . The trials defined delayed introduction of progressive enteral feeds as later than four to seven days after birth and early introduction as four days or less after birth . Meta-analyses did not detect statistically significant effects on the risk of NEC ( typical RR 0.93 , 95 % CI 0.64 to 1.34 ; 8 trials ; 1092 infants ) or all-cause mortality ( typical RR 1.18 , 95 % CI 0.75 to 1.88 ; 7 trials ; 967 infants ) . Four of the trials restricted participation to growth-restricted infants with Doppler ultrasound evidence of abnormal fetal circulatory distribution or flow . Planned subgroup analyses of these trials found no statistically significant effects on the risk of NEC or all-cause mortality . Infants who had delayed introduction of enteral feeds took longer to establish full enteral feeding ( reported median differences two to four days ) . AUTHORS ' CONCLUSIONS The evidence available from r and omised controlled trials suggested that delaying the introduction of progressive enteral feeds beyond four days after birth did not reduce the risk of developing NEC in very preterm or VLBW infants , including growth-restricted infants . Delaying the introduction of progressive enteral feeds result ed in a few days ' delay in establishing full enteral feeds but the clinical importance of this effect was unclear . The applicability of these findings to extremely preterm or extremely low birth weight was uncertain . Further r and omised controlled trials in this population may be warranted
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"Fifty nine infants of birthweight less than 1500 g were allocated alternately to initial total parenteral nutrition or to transpyloric feeding . Mortality was similar between the two groups . Ten of the 29 infants in the transpyloric group failed to establish full enteral nutrition during the first week of life . No beneficial effects on growth were shown in infants receiving parenteral nutrition . Acquired bacterial infection was higher in the parenteral group and associated with morbidity and mortality . Conjugated hyperbilirubinaemia occurred only in the parenterally fed infants . The incidence of necrotising enterocolitis was higher in the transpyloric group . Parenteral nutrition does not confer any appreciable benefit and because of greater complexity and higher risk of complications should be reserved for those infants in whom enteral feeding is impossible",
"BACKGROUND : Growth-restricted preterm infants are at increased risk of developing necrotizing enterocolitis ( NEC ) and initiation of enteral feeding is frequently delayed . There is no evidence that this delay is beneficial and it might further compromise nutrition and growth . METHODS : Infants with gestation below 35 weeks , birth weight below the 10th centile , and abnormal antenatal umbilical artery Doppler waveforms were r and omly allocated to commence enteral feeds “ early , ” on day 2 after birth , or “ late , ” on day 6 . Gradual increase in feeds was guided by a “ feeding prescription ” with rate of increase the same for both groups . Primary outcomes were time to achieve full enteral feeding sustained for 72 hours and NEC . RESULTS : Four hundred four infants were r and omly assigned from 54 hospitals in the United Kingdom and Irel and ( 202 to each group ) . Median gestation was 31 weeks . Full , sustained , enteral feeding was achieved at an earlier age in the early group : median age was 18 days compared with 21 days ( hazard ratio : 1.36 [ 95 % confidence interval : 1.11–1.67 ] ) . There was no evidence of a difference in the incidence of NEC : 18 % in the early group and 15 % in the late group ( relative risk : 1.2 [ 95 % confidence interval : 0.77–1.87 ] ) . Early feeding result ed in shorter duration of parenteral nutrition and high-dependency care , lower incidence of cholestatic jaundice , and improved SD score for weight at discharge . CONCLUSIONS : Early introduction of enteral feeds in growth-restricted preterm infants results in earlier achievement of full enteral feeding and does not appear to increase the risk of NEC",
"Background Pregnancies complicated by abnormal umbilical artery Doppler blood flow patterns often result in the baby being born both preterm and growth-restricted . These babies are at high risk of milk intolerance and necrotising enterocolitis , as well as post-natal growth failure , and there is no clinical consensus about how best to feed them . Policies of both early milk feeding and late milk feeding are widely used . This r and omised controlled trial aims to determine whether a policy of early initiation of milk feeds is beneficial compared with late initiation . Optimising neonatal feeding for this group of babies may have long-term health implication s and if either of these policies is shown to be beneficial it can be immediately adopted into clinical practice . Methods and Design Babies with gestational age below 35 weeks , and with birth weight below 10th centile for gestational age , will be r and omly allocated to an \" early \" or \" late \" enteral feeding regimen , commencing milk feeds on day 2 and day 6 after birth , respectively . Feeds will be gradually increased over 9 - 13 days ( depending on gestational age ) using a schedule derived from those used in hospitals in the Eastern and South Western Regions of Engl and , based on surveys of feeding practice . Primary outcome measures are time to establish full enteral feeding and necrotising enterocolitis ; secondary outcomes include sepsis and growth . The target sample size is 400 babies . This sample size is large enough to detect a clinical ly meaningful difference of 3 days in time to establish full enteral feeds between the two feeding policies , with 90 % power and a 5 % 2-sided significance level . Initial recruitment period was 24 months , subsequently extended to 38 months . Discussion There is limited evidence from r and omised controlled trials on which to base decisions regarding feeding policy in high risk preterm infants . This multicentre trial will help to guide clinical practice and may also provide pointers for future research .Trial registration Current Controlled Trials IS RCT N :",
"BACKGROUND Evidence -based practice guidelines for aggressive nutritional intervention by using parenteral amino acids ( AAs ) and minimal enteral feeding ( MEF ) as early as the first day of life have not been tested for benefits to bone mass . OBJECTIVE We investigated whether early introduction of parenteral AAs and MEF improves growth and bone mass achieved by term age in infants born prematurely . DESIGN Twenty-seven infants who were were r and omly assigned by using a 2 x 2 design to treatment of either 1 g AAs/kg within the first 24 h or 12 mL MEF x kg(-1 ) x d(-1 ) within the first 72 h of life . Nutrition and growth were documented during hospitalization , and bone mineral content ( BMC ) of lumbar spine 1 - 4 , femur , and whole body was measured at term age . Biomarkers of bone metabolism were measured at weeks 1 , 3 , and 5 and at discharge . Statistical analysis was conducted by using 2 x 2 analysis of variance for intent to treat and for infants receiving protocol nutrition . RESULTS Over the first 14 d of life , a main effect of early AAs elevated total intake of protein , and a main effect of early MEF was a higher frequency of MEF volumes exceeding > 12 mL x kg(-1 ) x d(-1 ) . Main effects on growth were not evident . An interaction effect was observed for osteocalcin whereby early AAs or MEF alone elevated osteocalcin . A main effect of early MEF yielded higher BMC of spine and femur . CONCLUSION Early aggressive nutrition support with MEF enhances BMC in premature infants , but early MEF or AAs do not improve growth",
"INTRODUCTION The development of necrotizing enterocolitis is a common and serious risk to newborns . It is caused by splanchnic bed vasoconstriction that can produce intestinal necrosis . The role of onset time , type and , speed enhancements of The factors of enteral feeding related with necrotizing enterocolitis genesis such as feeding onset , type and frequency are not well understood . OBJECTIVE The incidence of necrotizing enterocolitis and mortality among infants will be compared in infants whose enteral feeding was initiated 48 hours after birth to those whose feeding began on day 5 postpartum . MATERIAL S AND METHODS A controlled clinical trial was conducted among 239 newborns weighing between 750 - 1,500 g and a gestation age of 27 - 32 weeks of gestational age . The infants were r and omly assigned to two groups--135 to an early feeding regime and 104 to delayed feeding . Breast milk or formula milk was used . Feeding was begun with one ml every six hours , progressing to three hour intervals and 20 ml/kg daily . This was increased to 150 ml/kg-d if the infant condition remained stable and it manifested no oral intolerance . RESULTS In the early feeding group , 14 ( 10;4 % ) necrotizing enterocolitis cases occurred , and in the late feeding group , 9 ( 8.7 % ) occurred ( RR= 1.22 , 95 % CI 0.49 - 3.20 , p= 0.65 ) . Five children died in early feeding group ( 3.7 % , 95 % CI 1.4 - 8.9 ) and eight in late feeding group ( 7.7 % , 95 % CI 3.6 - 15.0 , RR=0.46 , 95 % CI 0.12 - 1,60 , p= 0.18 ) . CONCLUSION Early enteral feeding in preterm newborns does not increase the risk of necrotizing enterocolitis or mortality among them ; however it represents nutritional advantages for these infants",
"We studied the effect of early ( delayed ( > or = 6 days ) initiation of minimal enteral feeding ( MEF ) on the incidence of necrotizing enterocolitis ( NEC ) and feeding intolerance in preterm infants with intrauterine growth restriction ( IUGR ) and abnormal antenatal Doppler results . We performed a r and omized , nonblinded pilot trial of infants receiving early or delayed MEF in addition to parenteral feeding within 48 hours of life . Demographic data , maternal preeclampsia , antenatal steroid exposure , Doppler studies , as well as cases of NEC and feeding intolerance were all recorded . Of the 84 infants enrolled , 81 completed the study : 40 received early ( median age : 2 days , range : 1 to 5 days ) and 41 delayed ( median age : 7 days , range : 6 to 14 days ) MEF . The incidence of NEC and feeding intolerance was not significantly different between groups ( p = 0.353 and p = 0.533 , respectively ) . Birth weight was an independent risk factor for NEC in both groups . Early MEF of preterm infants with IUGR and abnormal antenatal Doppler results may not have a significant effect on the incidence of NEC or feeding intolerance . Furthermore , birth weight seems to be an independent risk factor for the development of NEC , irrespectively of the timing of MEF introduction",
"Objective To describe feeding and gastrointestinal outcomes in growth-restricted infants and to determine the rate of feed advancement which they tolerate . Design Analysis of prospect ively collected data from a r and omised feeding trial , the Abnormal Doppler Enteral Prescription Trial ( ADEPT ) . Setting 54 neonatal units in the UK and Irel and . Participants 404 preterm , growth-restricted infants with abnormal antenatal Doppler studies from ADEPT . 83 infants . Interventions In ADEPT , infants were r and omised to start milk ‘ early ’ on day 2 after birth , or ‘ late ’ on day 6 . Subsequent feed advancement followed a regimen , which should have achieved full feeds by day 16 in the early and day 20 in the late group . Main outcome measures Full feeds were achieved later in infants 0.3 to 0.5 ) . The incidence of necrotising enterocolitis was also higher in this group ; 32/83 ( 39 % ) compared to 32/312 ( 10 % ) in those ≥29 weeks ( RR 3.7 , 95 % CI 2.4 to 5.7 ) . Infants tolerated very little milk for the first 10 days of life and reached full feeds 9 days later than predicted from the trial regimen . Conclusions Growth-restricted infants born with abnormal antenatal Doppler failed to tolerate even the careful feeding regimen of ADEPT . A slower advancement of feeds may be required for these infants . Trial registration number IS RCT N87351483",
"OBJECTIVES : Infants who develop encephalopathy after perinatal asphyxia have an increased risk of death and adverse neurologic outcome . Conflicting results exist concerning outcome in healthy infants with metabolic acidosis at birth . The aim of the current study was to evaluate whether metabolic acidosis at birth in term infants who appear healthy is associated with long-term developmental abnormalities . METHODS : From a population -based cohort ( 14 687 deliveries ) , 78 infants were prospect ively identified as having metabolic acidosis ( umbilical artery pH 12.0 mmol/L ) . Two matched controls per case were selected . The child health and school health care records were scrutinized for developmental abnormalities . RESULTS : Outcome measures at 6.5 years of age for 227 of 234 children ( 97 % ) were obtained . No differences were found concerning neurologic or behavioral problems in need of referral action or neurodevelopmental diagnosis in comparison of control children with acidotic children who had appeared healthy at birth , ie , had not required special neonatal care or had no signs of encephalopathy . CONCLUSIONS : Infants born with cord metabolic acidosis and who appear well do not have an increased risk for neurologic or behavioral problems in need of referral actions or special teaching approaches at the age of 6.5 years",
"Background : The interrelations between early enteral feeding , necrotising enterocolitis ( NEC ) , and nosocomial sepsis ( NS ) remain unclear . Objective : To evaluate the effect of age at the introduction of enteral feeding on the incidence of NS and NEC in very low birthweight ( VLBW Methods : Data were collected on the pattern of enteral feeding and perinatal and neonatal morbidity on all VLBW infants born in one centre during 1995–2001 . Enteral feeding was compared between infants with and without NS and /or NEC . Results : The study sample included 385 infants . Of these , 163 ( 42 % ) developed NS and 35 ( 9 % ) developed NEC . Enteral feeding was started at a significantly earlier mean ( SD ) age in infants who did not develop nosocomial sepsis ( 2.8 ( 2.6 ) v 4.8 ( 3.7 ) days , p = 0.0001 ) . Enteral feeding was introduced at the same age in babies who did or did not develop NEC ( 3.1 ( 2 ) v 3.7 ( 3 ) days , p = 0.28 ) . Over the study period , the mean annual age at the start of enteral feeding fell consistently , and this correlated with the mean annual incidence of NS ( r2 = 0.891 , p = 0.007 ) . Multiple logistic regression analysis showed age at start of enteral feeding , respiratory distress syndrome , and birth weight to be the most significant predictors of risk of NS ( p = 0.0005 , p = 0.024 , p = 0.011 ) . Conclusions : Early enteral feeding was associated with a reduced risk of NS but no change in the risk of NEC in VLBW infants . These findings support the use of early enteral feeding in this high risk population , but this needs to be confirmed in a large r and omised controlled trial",
"AIMS To improve energy intake in sick very low birthweight ( VLBW ) infants ; to decrease growth problems , lessen pulmonary morbidity , shorten hospital stay , and avoid possible feeding related morbidity . Morbidity in VLBW infants thought to be associated with parenteral and enteral feeding includes bronchopulmonary dysplasia , necrotising enterocolitis , septicaemia , cholestasis and osteopenia of prematurity . METHODS A prospect i ve r and omised controlled trial ( RCT ) comparing two types of nutritional intervention was performed involving 125 sick VLBW infants in the setting of a regional neonatal intensive care unit . Babies were r and omly allocated to either an aggressive nutritional regimen ( group A ) or a control group ( group B ) . Babies in group B received a conservative nutritional regimen while group A received a package of more aggressive parenteral and enteral nutrition . Statistical analysis was done using Student’st test , the Mann-Whitney U test , the χ2 test and logistic regression . RESULTS There was an excess of sicker babies in group A , as measured by initial disease severity ( P mean total energy intakes were significantly higher ( P Survival and the incidences of bronchopulmonary dysplasia , septicaemia , cholestasis , osteopenia and necrotising enterocolitis were similar in both groups . Growth in early life and at discharge from hospital was significantly better in babies in group A. There were no decreases in pulmonary morbidity or hospital stay . CONCLUSION Nutritional intake in sick VLBW infants can be improved without increasing the risk of adverse clinical or metabolic sequelae . Improved nutritional intake result ed in better growth , both in the early neonatal period and at hospital discharge , but did not decrease pulmonary morbidity or shorten hospital stay",
"To begin to determine the optimal time for initiating enteral feedings , 34 sick , very low birth weight infants were prospect ively selected from all neonates of less than 1,500 g ( N = 116 ) and r and omly divided into two groups . Infants were fed either on day 1 ( early ) or 7 ( late ) of life , according to a feeding protocol which included parenteral nutrition and a scheduled progression from sterile water to 2.5 % dextrose , half-strength , and finally full-strength formula over seven days . The incidence of necrotizing enterocolitis and subsequent hospital course were compared . Initiating enteral feedings on day 1 did not significantly increase the incidence of necrotizing enterocolitis , produce a clustering of cases , or induce an earlier onset of necrotizing enterocolitis . The overall incidence of necrotizing enterocolitis in sick , very low birth weight neonates was 29 % ( 5/17 ) and 35 % ( 6/17 ) in the early and late groups , respectively , compared with 4.2 % ( 2/47 ) in minimally sick , very low birth weight neonates . No significant differences between groups were seen in obstetrical complications , birth weight , gestational age , Apgar scores , presence of patent ductus arteriosus or intraventricular hemorrhage , use of umbilical catheterization , and respiratory or oxygen requirements . Infants fed enterally from day 1 did show a significantly higher energy and protein intake during the second week of life . These data show that providing dilute , early enteral calories does not adversely affect the incidence of necrotizing enterocolitis",
"AIM Pregnancies complicated by abnormal antenatal Doppler blood flow often result in the preterm delivery of a growth restricted baby . These babies have a high risk of milk intolerance and necrotising enterocolitis ( 1 ) , and introduction of milk feeds is frequently delayed . Our aim was to determine the effect of early or late introduction on success of achieving full milk feeds and on adverse outcomes including NEC . METHODS Eligible babies with birthweight below 10th centile and gestation below 34 + 6 weeks , born after abnormal antenatal Dopplers , were r and omised between 20 and 48 hours to either early ( 24 - 48 hours ) or late ( 120 - 144 hours ) introduction of milk feeds . Babies with major congenital anomaly , in-utero transfusion , multi-organ failure or need for inotropes were excluded . Feed volumes and rate of increase were st and ardised , and were the same for both groups . Daily feed logs were kept . RESULTS 404 babies were r and omised from 56 units in U.K. and Irel and ( 202 in each group ) . There were no important differences between groups at r and omisation . CONCLUSION growth restricted preterm infants born after absent or reversed end-diastolic flow in the umbilical artery who are fed from the second day after birth achieve full feeds faster than those commencing feeds on day six . No difference was been seen in the incidence of NEC , in preliminary analysis . Final data analysis is currently being completed and will be presented at the conference",
"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",
"OBJECTIVE To compare the effects of continuous versus intermittent feeding on gastrointestinal tolerance and growth in very low birth weight ( VLBW ) infants . STUDY DESIGN In a r and omized , controlled trial conducted at 3 neonatal units , 70 premature infants with a gestational age 24 to 29 weeks and birth weight were assigned to 1 of 3 feeding methods : continuous nasogastric feeding , intermittent nasogastric feeding , or intermittent orogastric feeding . Feeding was initiated within 30 hours of birth . Daily enteral and parenteral volumes , caloric and protein intakes , growth , enteral intolerance , and clinical complications were recorded . Cox regression analysis was used to determine primary outcome , the time to achieve full enteral feeding . RESULTS The continuously fed infants achieved full enteral feeding significantly faster than the intermittently fed infants ( hazard ratio [ HR ] = 1.86 ; 95 % confidence interval [ CI ] = 1.07 to 3.22 ) . In stratified analysis according to birth weight , the improvement was even more pronounced in the smallest infants , those with birth weight Growth rate was significantly faster in the continuously fed infants ( P = .002 ) . CONCLUSION In VLBW infants , continuous feeding seems to be better than intermittent feeding with regard to gastrointestinal tolerance and growth",
"In a prospect i ve multicentre study on 926 preterm infants formally assigned to their early diet , necrotising enterocolitis developed in 51 ( 5.5 % ) . Mortality was 26 % in stringently confirmed cases . In exclusively formula-fed babies confirmed disease was 6 - 10 times more common than in those fed breast milk alone and 3 times more common than in those who received formula plus breast milk . Pasteurised donor milk seemed to be as protective as raw maternal milk . Among babies born at more than 30 weeks ' gestation confirmed necrotising enterocolitis was rare in those whose diet included breast milk ; it was 20 times more common in those fed formula only . Other risk factors included very low gestational age , respiratory disease , umbilical artery catheterisation , and polycythaemia . In formula-fed but not breast-milk-fed infants , delayed enteral feeding was associated with a lower frequency of necrotising enterocolitis . With the fall in the use of breast milk in British neonatal units , exclusive formula feeding could account for an estimated 500 extra cases of necrotising enterocolitis each year . About 100 of these infants would die",
"Background and Objectives : Controversy exists regarding the optimal enteral feeding regimen of very low birth weight infants ( VLBW ) . Rapid advancement of enteral feeding has been associated with an increased rate of necrotizing enterocolitis . In contrast , delaying enteral feeding may have unfavorable effects on nutrition , growth , and neurodevelopment . The aim is to compare the short-term outcomes of VLBW infants in tertiary care centers according to their enteral feeding advancement . Patients and Methods : We prospect ively studied the influence of center-specific enteral feeding advancement in 1430 VLBW infants recruited from 13 tertiary neonatal intensive care units in Germany on short-term outcome parameters . The centers were post hoc stratified to “ rapid advancement to full enteral feeds ” ( median duration of advancement to full enteral feeds ≤12.5 days ; 6 centers ) , that is , rapid advancement ( RA ) , or “ slow advancement to full enteral feeds ” ( median duration of advancement to full enteral feeds > 12.5 days ; 7 centers ) , that is , slow advancement ( SA ) . Results : VLBW infants born in centers with SA ( n = 713 ) had a significantly higher rate of sepsis compared with VLBW infants born in centers with RA ( n = 717 ) , which was particularly evident for late-onset sepsis ( 14.0 % vs 20.4 % ; P = 0.002 ) . Furthermore , more central venous lines ( 48.6 % vs 31.1 % , P on short-term outcomes such as nosocomial sepsis . Large , multicenter , prospect i ve trials are required to further eluci date the optimal feeding strategy for VLBW infants",
"OBJECTIVE To examine the effect of initiating very early feeding on time-to-reach full feeding in stable , small for gestational age ( SGA ) preterm infants . METHOD Preterm infants with gestational age below 37 weeks and birth weight below the 10(th ) percentile were r and omly allocated to a very early ( within 24 hours of birth ) feeding regimen or delayed ( after 24 hours of birth ) feeding . All infants had in utero evidence of absent or reverse diastolic flow . Infants unable to start early feeding were excluded . Time-to-reach full feeding , feeding progression , and related morbidity were compared . Electrogastrography ( EGG ) was used to measure pre- and postpr and ial gastric motility on the second and seventh day after feeding initiation . RESULTS Sixty infants were included in the study , 30 in each group . Infants included in the very early feeding regimen achieved full enteral feeding sooner than controls ( 98±80 - 157 vs. 172±123 - 261 hours of age , respectively ; p= 0.004 ) and were discharged home earlier ( p=0.04 ) . No necrotizing enterocolitis ( NEC ) was documented in both study groups . Gastric motility was improved at day seven after feeding initiation in both study groups , with no difference between groups . CONCLUSIONS Stable SGA preterm infants on a very early feeding regimen achieved full enteral feeding and were discharged home significantly earlier than those on a delayed regimen , with no excess morbidity",
"Background : Most preterm infants who develop necrotising enterocolitis ( NEC ) have received enteral feeds . Uncertainty exists about which aspects of the feeding regimen affect the risk of NEC . Aim : To examine associations between various enteral feeding practice s and the development of NEC in preterm infants . Methods : Multicentre case – control study . 53 preterm infants with NEC were enrolled together with a gestational age frequency-matched control without NEC from a r and omly selected neonatal unit . Clinical and feeding data were extracted and compared between the groups . Results : Significantly fewer cases than controls had received human breast milk ( 75 % vs 91 % ; OR 0.32 , 95 % CI 0.11 to 0.98 ) . The day on which enteral feeding was started did not differ significantly ( mean ( SD ) days after birth : cases 2.9 ( 2.8 ) and controls 2.8 ( 1.8 ) ) . The mean ( SD ) duration of trophic feeding ( fully fed significantly earlier than controls ( mean ( SD ) days after birth : cases 9.9 ( 4.2 ) and controls 14.3 ( 9.8 ) ; MD −4.4 , 95 % CI −7.3 to −1.5 ) . Conclusions : These data suggest that the duration of trophic feeding and rate of advancement of feed volumes may be modifiable risk factors for NEC in preterm infants . Further r and omised controlled trials are warranted to assess the effect of different rates of feed advancement on the incidence of NEC , as well as other outcomes",
"OBJECTIVE To evaluate the role of middle cerebral artery Doppler in small fetuses during the late third trimester . DESIGN Prospect i ve observational study of structurally normal fetuses with an estimated fetal weight Perinatal outcome was determined using a structured data sheet sent to each referring obstetrician . SUBJECTS Structurally normal fetuses at 35 or more weeks of gestation referred during a 2-year period to the fetal growth clinic of a regional fetal medicine unit in North London . Fetuses with aneuploidy and /or major structural abnormalities were excluded . METHODS Umbilical artery and middle cerebral artery ( MCA ) Doppler waveforms were recorded and considered abnormal if above 95th or below 5th percentiles , respectively . Amniotic fluid was considered reduced if the maximum vertical cord-free pool was head circumference (HC)/abdominal circumference ( AC ) ratio was considered abnormal if > 95th percentile for gestation . Fetal growth , amniotic fluid , biophysical profile score and umbilical artery Doppler were used to advise the referring obstetrician about fetal well-being and he/she independently decided both the timing and mode of delivery . RESULTS Forty-seven fetuses fulfilled the entry criteria . Thirty-four ( 72 % ) demonstrated normal umbilical artery Doppler waveforms . Sixteen ( 34 % ) demonstrated middle cerebral artery redistribution , of which nine ( 56 % ) had normal umbilical artery Doppler waveforms . MCA blood flow redistribution was associated with an increased incidence of cesarean delivery and need for neonatal admission . Of all gray-scale parameters , an elevated HC/AC ratio has the strongest association with MCA blood flow redistribution ( 15/16 vs. 1/31 ; P small fetuses in the late third trimester . Redistribution may occur in the presence of normal umbilical artery Doppler and should be suspected when the HC/AC ratio is elevated",
"To explore the possibility that the intestinal motor response to feeding is intact even in infants with immature fasting patterns , we performed low-compliance , continuous-infusion manometry in 13 term and 23 preterm infants during the first postnatal week . Babies were fed a st and ard formula intraduodenally at 4 ml/kg/2 hr by infusion pump . Small bowel motility responded to feeding ; fasting patterns were replaced with long periods of persistent activity . During the infusion of formula , there was no significant difference in motor activity between preterm and term infants . Four characteristics of motor activity changed with feeding : motility index , the number of pressure peaks per 30-minute period , mean amplitude of pressure peaks , and duration of periods of quiescence . The number of pressure peaks per 30-minute period was the most sensitive index of the motor response to feeding , and it was used to characterize the fed pattern response . The start and duration of the fed response were similar in both groups of infants . Thus , despite the presence of immaturity in fasting patterns , the intestine of the preterm infant responds appropriately to feeding . These data help explain why preterm infants usually tolerate antral feedings , and support their use",
"A controlled prospect i ve study was undertaken of 62 high-risk low-birth-weight infants to evaluate the effect of expressed human milk on the prevention of infection . One half received EHM and the remaining half were administered the nursery formula . There was no statistically significant difference in the predisposing factors in the two groups . Infections , however , were much fewer in babies who received EHM (",
"BACKGROUND Data on enteral feeding management of premature infants are limited and often not the subject of r and omized clinical trials . Several small studies suggest benefits from the early initiation of feeding , but do not assess the combined effects of time of initiation of feeding , tube-feeding method , and type of milk used . Either singly or in combination , these treatments may affect growth , bone mineralization , biochemical measures of nutritional status , and feeding tolerance , and , ultimately , the duration of hospitalization . METHODS A total of 171 premature infants , stratified by gestational age ( 26 to 30 weeks ) and diet ( human milk or preterm formula ) were assigned r and omly among four treatment combinations in a balanced two-way design comparing the presence or absence of gastrointestinal ( GI ) priming for 10 days and continuous infusion versus intermittent bolus tube-feeding . RESULTS The major outcome , time required for infants to attain full oral feeding , was similar among treatments . GI priming was not associated with any measured adverse effect and was associated with better calcium and phosphorus retention , higher serum calcium and alkaline phosphatase activity , and shorter intestinal transit times . The bolus tube-feeding method was associated with significantly less feeding intolerance and greater rate of weight gain than the continuous method . In addition , the greater the quantity of human milk fed , the lower the morbidity . CONCLUSIONS Early GI priming with human milk , using the bolus tube-feeding method , may provide the best advantage for the premature infant",
"OBJECTIVE The objective of this prospect i ve , r and omized clinical trial was to test the hypothesis that there is no difference in the frequency of feeding problems and necrotizing enterocolitis between a group of premature infants who received early enteral feedings while low umbilical artery catheters ( LUACs ) were in place , and a late group who were not fed until 24 hours after removal of LUACs . PATIENTS AND METHODS Twenty-nine premature infants ( born at 28.5 + /- 3.0 SD weeks of gestational age ) who were in stable condition received early enteral feedings at a median of 2 days while a LUAC was in place ; 31 infants ( born at 28.6 + /- 2.7 SD weeks of gestational age ) received late enteral feedings at a median of 5 days of age , 24 hours after the removal of the LUAC . Feeding complications and interventions and nutritional characteristics were recorded prospect ively . RESULTS There were no differences in the baseline perinatal characteristics of the two groups . The incidence of gastric residua and the incidence of abdominal distention were the same in both groups . The early feeding group had significantly fewer percutaneous central venous catheters , evaluations for sepsis , and episodes of receiving nothing by mouth while a gastric suction tube was in place . Infants in the early group received parenteral alimentation-lipid emulsion infusions for a median of 13 days versus 30 days for the late-fed group ( p = 0.0028 by Wilcoxon test ) . There were two cases of necrotizing enterocolitis in the early group versus four cases in the late group . CONCLUSIONS Premature infants in stable condition who receive enteral feedings while LUACs are in place do not have an increased incidence of feeding problems compared with infants who do not receive enteral feedings until 24 hours after removal of LUACs"
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PURPOSE To summarize measurement instruments used to evaluate activity limitations and participation restrictions in patients with chronic fatigue syndrome ( CFS ) and review the psychometric properties of these instruments . METHOD General information of all included measurement instruments was extracted . The method ological quality was evaluated using the COSMIN checklist . Results of the measurement properties were rated based on the quality criteria of Terwee et al. Finally , overall quality was defined per psychometric property and measurement instrument by use of the quality criteria by Schellingerhout et al. RESULTS A total of 68 articles were identified of which eight evaluated the psychometric properties of a measurement instrument assessing activity limitations and participation restrictions . One disease-specific and 37 generic measurement instruments were found . Limited evidence was found for the psychometric properties and clinical usability of these instruments . However , the CFS-activities and participation question naire ( APQ ) is a disease-specific instrument with moderate content and construct validity . CONCLUSION The psychometric properties of the review ed measurement instruments to evaluate activity limitations and participation restrictions are not sufficiently evaluated . Future research is needed to evaluate the psychometric properties of the measurement instruments , including the other properties of the CFS-APQ . If it is necessary to use a measurement instrument , the CFS-APQ is recommended . IMPLICATION S FOR REHABILITATION Chronic fatigue syndrome ( CFS ) . Chronic fatigue syndrome causes activity limitations and participation restrictions in one or more areas of life . St and ardized , reliable and valid measurement instruments are necessary to identify these limitations and restrictions . Currently , no measurement instrument is sufficiently evaluated with persons with CFS . If a measurement instrument is needed to identify activity limitations and participation restrictions with persons with CFS , it is recommended to use the CFS-APQ in clinical practice and scientific research
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"Abstract Objective : To assess the efficacy of an educational intervention explaining symptoms to encourage grade d exercise in patients with chronic fatigue syndrome . Design : R and omised controlled trial . Setting : Chronic fatigue clinic and infectious diseases outpatient clinic . Subjects : 148 consecutively referred patients fulfilling Oxford criteria for chronic fatigue syndrome . Interventions : Patients r and omised to the control group received st and ardised medical care . Patients r and omised to intervention received two individual treatment sessions and two telephone follow up calls , supported by a comprehensive educational pack , describing the role of disrupted physiological regulation in fatigue symptoms and encouraging home based grade d exercise . The minimum intervention group had no further treatment , but the telephone intervention group received an additional seven follow up calls and the maximum intervention group an additional seven face to face sessions over four months . Main outcome measure : A score of 25 or an increase of 10 on the SF-36 physical functioning subscale ( range 10 to 30 ) 12 months after r and omisation . Results : 21 patients dropped out , mainly from the intervention groups . Intention to treat analysis showed 79 ( 69 % ) of patients in the intervention groups achieved a satisfactory outcome in physical functioning compared with two ( 6 % ) of controls , who received st and ardised medical care ( P observed in fatigue , sleep , disability , and mood . No significant differences were found between the three intervention groups . Conclusions : Treatment incorporating evidence based physiological explanations for symptoms was effective in encouraging self managed grade d exercise . This result ed in substantial improvement compared with st and ardised medical care",
"Background Scant research has adequately addressed the impact of chronic fatigue syndrome on patients ' daily activities and quality of life . Enumerating specific problems related to quality of life in chronic fatigue syndrome patients can help us to better underst and and manage this illness . This study addresses issues of functional status in persons with chronic fatigue syndrome and other fatiguing illnesses in a population based sample , which can be generalized to all persons with chronic fatigue . Methods We conducted a r and om telephone survey in Wichita , Kansas to identify persons with chronic fatigue syndrome and other fatiguing illnesses . Respondents reporting severe fatigue of at least 1 month 's duration and r and omly selected non-fatigued respondents were asked to participate in a detailed telephone interview . Participants were asked about symptoms , medical and psychiatric illnesses , and about physical , social , and recreational functioning . Those meeting the 1994 chronic fatigue syndrome case definition , as determined on the basis of their telephone responses , were invited for clinical evaluation to confirm a diagnosis of chronic fatigue syndrome . For this analysis , we evaluated unemployment due to fatigue , number of hours per week spent on work , chores , and other activities ( currently and prior to the onset of fatigue ) , and energy level . Results There was no difference between persons with chronic fatigue syndrome and persons with a chronic fatigue syndrome-like illness that could be explained by a medical or psychiatric condition for any of the outcomes we measured except for unemployment due to fatigue ( 15 % vs. 40 % , P Persons with chronic fatigue syndrome and other fatiguing illnesses had substantially less energy and spent less time on hobbies , schooling , or volunteer work than did non-fatigued controls ( P Persons with chronic fatigue syndrome are as impaired as persons whose fatigue could be explained by a medical or psychiatric condition , and they have less energy than non-fatigued controls",
"OBJECTIVES This study aim ed to examine the associations between bodily pain , pain catastrophizing , depression , activity limitations /participation restrictions , employment status , and exercise performance in female patients with chronic fatigue syndrome ( CFS ) who experience widespread pain . DESIGN Cross-sectional observational study . SETTING A university-based clinic . PATIENTS Thirty-six female CFS patients who experienced widespread pain . OUTCOME MEASURES Patients filled in the Medical Outcomes Short-Form 36 Health Status Survey , the Chronic Fatigue Syndrome Activities and Participation Question naire , the Beck Depression Inventory , and the Pain Catastrophizing Scale , and underwent a maximal exercise stress test with continuous monitoring of electrocardiographic and ventilatory parameters . RESULTS Pain catastrophizing was related to bodily pain ( r = -0.70 ) , depression ( r = 0.55 ) , activity limitations /participation restrictions ( r = 0.68 ) , various aspects of quality of life ( r varied between -0.51 and -0.64 ) , and exercise capacity ( r varied between -0.41 and -0.61 ) . Based on hierarchical multiple regression analysis , pain catastrophizing accounted for 41 % of the variance in bodily pain in female CFS patients who experience chronic widespread musculoskeletal pain . Among the three subscale scores of the Pain Catastrophizing Scale , helplessness and rumination rather than magnification were strongly related to bodily pain . Neither pain catastrophizing nor depression was related to employment status . CONCLUSIONS These data provide evidence favoring a significant association between pain catastrophizing , bodily pain , exercise performance , and self-reported disability in female patients with CFS who experience widespread pain . Further prospect i ve longitudinal study ing of these variables is required",
"Abstract The effect of therapists in psychotherapy is a much debated topic , with a number of studies showing therapist variance being large while other studies show little or no variability in outcomes due to therapists . The aim of this study was to investigate therapist effects in a well-defined sample of patients and therapists from an outpatient service which specializes in providing cognitive behaviour therapy ( CBT ) for patients with chronic fatigue syndrome ( CFS ) . Therapy was provided in a highly specialized clinical setting for CFS and was delivered by qualified CBT therapists with at least 2 years experience with this client group . Three hundred and seventy-four patients with CFS and 12 cognitive behavioural psychotherapists took part . Therapist effects on the primary outcomes of fatigue and disability were investigated with multilevel r and om effects models and variance component analysis . Different models were computed and compared . Results showed a reduction in fatigue and disability scores after therapy . Variance explained by therapists , when demographic covariates were accounted for , was 0 % for fatigue and under 2 % for disability . A number of important factors may have played a significant role in minimizing therapist effects in our study . These are : specialist setting , single centre , patients with the same primary diagnosis , therapists of the same orientation and training , shared environment and supervision . Future studies may stress the importance of these factors in the investigation of the therapist effect in psychotherapy",
"Abstract Objective : To evaluate the acceptability and efficacy of adding cognitive behaviour therapy to the medical care of patients presenting with the chronic fatigue syndrome . Design : R and omised controlled trial with final assessment at 12 months . Setting : An infectious diseases outpatient clinic . Subjects : 60 consecutively referred patients meeting consensus criteria for the chronic fatigue syndrome . Interventions : Medical care comprised assessment , advice , and follow up in general practice . Patients who received cognitive behaviour therapy were offered 16 individual weekly sessions in addition to their medical care . Main outcome measures : The proportions of patients ( a ) who achieved normal daily functioning ( Karnofsky score 80 or more ) and ( b ) who achieved a clinical ly significant improvement in functioning ( change in Karnofsky score 10 points or more ) by 12 months after r and omisation . Results : Only two eligible patients refused to participate . All r and omised patients completed treatment . An intention to treat analysis showed that 73 % ( 22/30 ) of recipients of cognitive behaviour therapy achieved a satisfactory outcome as compared with 27 % ( 8/30 ) of patients who were given only medical care ( difference 47 percentage points ; 95 % confidence interval 24 to 69 ) . Similar differences were observed in subsidiary outcome measures . The improvement in disability among patients given cognitive behaviour therapy continued after completion of therapy . Illness beliefs and coping behaviour previously associated with a poor outcome changed more with cognitive behaviour therapy than with medical care alone . Conclusion : Adding cognitive behaviour therapy to the medical care of patients with the chronic fatigue syndrome is acceptable to patients and leads to a sustained reduction in functional impairment . Key messages Key messages There is no generally accepted form of treatment New findings show that patients referred to hospital for the chronic fatigue syndrome have a better outcome if they are given a course of cognitive behaviour therapy than if they receive only basic medical care Clinical improvement with cognitive behaviour therapy may be slow but often continues after treatment has ended Cognitive behaviour therapy should be considered as an option for patients presenting with the chronic fatigue",
"Objectives For the measurement of patient-reported outcomes , such as ( health-related ) quality of life , often many measurement instruments exist that intend to measure the same construct . To facilitate instrument selection , our aim was to develop a highly sensitive search filter for finding studies on measurement properties of measurement instruments in PubMed and a more precise search filter that needs less abstract s to be screened , but at a higher risk of missing relevant studies . Methods A r and om sample of 10,000 PubMed records ( 01 - 01 - 1990 to 31 - 12 - 2006 ) was used as a gold st and ard . Studies on measurement properties were identified using an exclusion filter and h and search ing . Search terms were selected from the relevant records in the gold st and ard as well as from 100 systematic review s of measurement properties and combined based on sensitivity and precision . The performance of the filters was tested in the gold st and ard as well as in two validation sets , by calculating sensitivity , precision , specificity , and number needed to read . Results We identified 116 studies on measurement properties in the gold st and ard . The sensitive search filter was able to retrieve 113 of these 116 studies ( sensitivity 97.4 % , precision 4.4 % ) . The precise search filter had a sensitivity of 93.1 % and a precision of 9.4 % . Both filters performed very well in the validation sets . Conclusion The use of these search filters will contribute to evidence -based selection of measurement instruments in all medical fields",
"Given the lack of evidence in support of pacing self-management for patients with chronic fatigue syndrome ( CFS ) , we examined whether physical behavior and health status of patients with CFS would improve in response to a pacing self-management program . We performed an observational study of pacing self-management in seven CFS patients using a single-case study design . Stages A1 and A2 ( 7-day assessment periods ) of the A1-B-A2 design corresponded to the baseline and posttreatment measurements of physical behavior ( real-time activity monitoring ) and health status ( self-reported measures ) , respectively . Stage B ( 3 weeks of treatment ) consisted of three individual treatment sessions of pacing self-management . When comparing pre- versus posttreatment data , we found that the patients ' ability to perform daily activities and the severity of their symptom complexes were improved ( p = 0.043 ) . Concentration difficulties , mood swings , muscle weakness , and intolerance to bright light improved as well . A statistically significant decrease in the mean time spent doing light activity ( physical activity was spread throughout the day was not . We found that 3 weeks of pacing self-management was accompanied by a modest improvement in symptom severity and daily functioning . The outcome of the present study calls for a r and omized controlled clinical trial to examine the effectiveness of pacing self-management for people with CFS",
"BACKGROUND Disability is a defining feature of chronic conditions , and it is an increasingly used measure of therapy effectiveness . The Work and Social Adjustment Scale ( WSAS ) is a simple and clear measure of disability . Although the scale is widely used , no study has yet investigated its psychometric properties in patients with chronic fatigue syndrome ( CFS ) . METHODS Data from two sample s of patients were used , one from a multicenter r and omized controlled clinical trial of treatments for CFS ( n = 639 ) and the other from a clinic that specializes in CFS ( n=384 ) . All patients completed the WSAS as well as other measures . RESULTS Internal consistency and the Spearman-Brown split-half coefficient values indicated that the scale is reliable . CFS patients who had comorbid diagnoses of depression , anxiety or fibromyalgia had higher WSAS scores . High levels of disability were associated with high number of physical symptoms , severe fatigue , depression , anxiety , poor sleep quality and poor physical fitness , with correlation coefficients ranging between 0.41 and 0.11 . Lower scores on the WSAS were modestly associated with better physical functioning as well as higher levels of physical capacity as assessed by a walking test . Sensitivity to change was evaluated in a subgroup of patients who had undergone a course of cognitive behavioral therapy . Disability significantly decreased after therapy and remained stable at follow-ups . CONCLUSION The WSAS is a reliable and valid assessment tool for disability in patients with CFS",
"Objective : To evaluate the outcome of a multidisciplinary treatment programme for patients with chronic fatigue syndrome , including health-related quality of life ( HRQoL ) and psychosocial variables , and exercise capacity measures . Design : A six-month prospect i ve outcome study . Setting : University outpatient rehabilitation clinic ; group setting . Subjects : One hundred and sixteen women fulfilling chronic fatigue syndrome criteria . Interventions : Cognitive behaviourally and grade d exercise-based strategies ; emphasis on adaptive lifestyle changes . Measures : Short Form General Health Survey ( SF-36 ) ; Symptom Checklist ( SCL-90 ) ; Causal Attribution List ( CAL ) ; Self-Efficacy Scale ( SE ) ; maximum progressive bicycle ergometer test with respiratory gas analysis ; and isokinetic leg strength test , before and after treatment . Results : The total group significantly improved on nearly all reported HRQoL/ psychosocial variables . Changes in exercise capacity measures were rather modest and did not correlate or only weakly correlated with HRQoL/psychosocial variables . Subgroup analyses indicated that less fit patients improved significantly more on exercise capacity measures than their more fit counterparts . Patients who were fitter at baseline scored better on pretreatment HRQoL/psychosocial variables , but both subgroups improved similarly on these variables . Conclusions : Health-related quality of life and psychosocial functioning in patients with chronic fatigue syndrome improves after a six-month cognitive behaviourally and grade d exercise-based multidisciplinary treatment programme . Increase in exercise capacity measures is not a necessary condition for reported improvements , except for less fit patients",
"Objective : In an attempt to examine whether impairments in cardiorespiratory fitness are associated with daily functioning in patients with chronic fatigue syndrome ( CFS ) , this study addresses the correlations between exercise capacity and activity limitations /participation restrictions . Design : Prospect i ve observational study . Setting : An outpatient tertiary care , chronic fatigue clinic at the Vrije Universiteit Brussel ( VUB ) , Belgium . Subjects : Seventy-seven patients fulfilling the 1994 Centers for Disease Control and Prevention ( CDC ) case definition for CFS . Interventions : All patients filled in the Chronic Fatigue Syndrome Activities and Participation Question naire ( CFS-APQ ) and performed a maximal exercise stress test on a bicycle ergometer . Heart rate was monitored continuously by use of an electrocardiograph . Metabolic and ventilatory parameters were measured through spirometry . Results : A statistically significant correlation between the score obtained with the CFS-APQ and the body weight-adjusted peak oxygen uptake ( Spearman rho = -0.32 ; p = 0.005 ) , functional aerobic impairment ( rho = 0.33 ; p = 0.004 ) , workload/body weight ( rho = -0.30 ; p = 0.009 ) , exercise duration ( rho = -0.30 ; p = 0.008 ) , and the percentage of target heart rate achieved ( rho = -0.33 ; p = 0.004 ) was observed . The correlations between the remaining exercise capacity parameters and the scores obtained with the CFS-APQ all indicated a trend towards association ( 0.01 patients with CFS . The observed correlations lack strength to predict activity limitations / participation restriction based on exercise capacity parameters . Disability evaluation in CFS should therefore encompass both exercise capacity testing and measurements at the activity/participation dimension",
"Objective : It was hypothesized that the use of exercise limits prevents symptom increases and worsening of their health status following a walking exercise in people with chronic fatigue syndrome . Design : An uncontrolled clinical trial ( semi-experimental design ) . Setting : Outpatient clinic of a university department . Subjects : Twenty-four patients with chronic fatigue syndrome . Interventions : Subjects undertook a walking test with the two concurrent exercise limits . Each subject walked at an intensity where the maximum heart rate was determined by heart rate corresponding to the respiratory exchange ratio = 1.0 derived from a previous submaximal exercise test and for a duration calculated from how long each patient felt they were able to walk . Main outcome measures : The Short Form 36 Health Survey or SF-36 , the Chronic Fatigue Syndrome Symptom List , and the Chronic Fatigue Syndrome — Activities and Participation Question naire were filled in prior to , immediately after and 24 hours after exercise . Results : The fatigue increase observed immediately post-exercise ( P= 0.006 ) returned to pre-exercise levels 24 hours post-exercise . The increase in pain observed immediately post-exercise was retained at 24 hours post-exercise ( P=0.03 ) . Fourteen of the 24 subjects experienced a clinical ly meaningful change in bodily pain ( change of SF-36 bodily pain score ≥10 ) ; 6 indicated that the exercise bout had slightly worsened their health status , and 2 had a clinical ly meaningful decrease in vitality ( change of SF-36 vitality score ≥20 ) . There was no change in activity limitations /participation restrictions . Conclusion : It was shown that the use of exercise limits ( limiting both the intensity and duration of exercise ) prevents important health status changes following a walking exercise in people with chronic fatigue syndrome , but was unable to prevent short-term symptom increases",
"BACKGROUND Chronic fatigue syndrome ( CFS ) is a condition that may be associated with substantial disability . The Medical Outcomes Study Short-Form General Health Survey ( SF-36 ) is an instrument that has been widely used in outpatient population s to determine functional status . Our objectives were to describe the usefulness of the SF-36 in CFS patients and to determine if subscale scores could distinguish patients with CFS from subjects with unexplained chronic fatigue ( CF ) , major depression ( MD ) , or acute infectious mononucleosis ( AIM ) , and from healthy control subjects ( HC ) . An additional goal was to ascertain if subscale scores correlated with the signs and symptoms of CFS or the presence of psychiatric disorders and fibromyalgia . DESIGN Prospect ively collected case series . SETTING Patients with CFS and CF were seen in a university-based referral clinic and had undergone a complete medical and psychiatric evaluation . Other study subjects were recruited from the community to participate in research studies . PARTICIPANTS The study included 185 patients with CFS , 246 with CF , 111 with AIM , and 25 with MD . There were 99 HC subjects . MEASURES The SF-36 and a structured psychiatric interview were used . The SF-36 contains 8 subscales : physical , emotional , social , and role functioning , body pain , mental health , vitality , and general health- and a structured psychiatric interview . RESULTS Performance characteristics ( internal reliability coefficients , convergent validity ) of the SF-36 were excellent . A strikingly consistent pattern was found for the physical functioning , role functioning , social functioning , general health , and body pain subscales , with the lowest scores in CFS patients , intermediate scores in AIM patients , and the highest scores in the HC subjects . The CFS patients had significantly lower scores than patients with CF alone on the physical functioning ( P role functioning ( P body pain ( P emotional functioning and mental health scores were worst among those with MD . The presence of fibromyalgia , being unemployed , and increasing fatigue severity all were associated with additional functional limitations across multiple functional domains , with increasing fatigue appearing to have the greatest effect . CONCLUSIONS The SF-36 is useful in assessing functional status in patients with fatiguing illnesses . Patients with CFS and CF have marked impairment of their functional status . The severity and pattern of impairment as documented by the SF-36 distinguishes patients with CFS and CF from those with MD and AIM , and from HC , but does not discriminate between CF and CFS",
"Chronic fatigue syndrome ( CFS ) produces physical and neurocognitive disability that significantly affects health-related quality of life ( HRQL ) . Multidisciplinary treatment combining grade d exercise therapy ( GET ) cognitive behavioural therapy ( CBT ) and pharmacological treatment has shown only short-term improvements . To compare the effects on HRQL of ( 1 ) multidisciplinary treatment combining CBT , GET , and pharmacological treatment , and ( 2 ) usual treatment ( exercise counselling and pharmacological treatment ) at 12 months of follow-up . Prospect i ve , r and omized controlled trial with a follow-up of 12 months after the end of treatment . Patients consecutively diagnosed with CFS ( Fukuda criteria ) were r and omly assigned to intervention ( n = 60 ) or usual treatment ( n = 60 ) groups . HRQL was assessed at baseline and 12 months by the Medical Outcomes Study Short-Form question naire ( SF-36 ) . Secondary outcomes included functional capacity for activities of daily living measured by the Stanford Health Assessment Question naire ( HAQ ) and comorbidities . At baseline , the two groups were similar , except for lower SF-36 emotional role scores in the intervention group . At 12 months , the intervention did not improve HRQL scores , with worse SF-36 physical function and bodily pain scores in the intervention group . Multidisciplinary treatment was not superior to usual treatment at 12 months in terms of HRQL . The possible benefits of GET as part of multidisciplinary treatment for CFS should be assessed on an individual patient basis",
"Background : It has been argued that perceived functional incapacity might be a primary characteristic of chronic fatigue syndrome ( CFS ) and could be explained by physical symptoms . If so , it could be expected to be closely associated with physical , but not psychological symptoms . The study tests this hypothesis . Sampling and Methods : The sample consisted of 73 patients , with a diagnosis of CFS according to the Oxford criteria , r and omly selected from clinics in the Departments of Immunology and Psychiatry at St. Bartholomew ’s Hospital , London . The degree of fatigue experienced by patients was assessed using the Chalder Fatigue Question naire and a visual analogue scale . Self-rated instruments were used to measure physical and social functioning , quality of life , and physical and psychological symptoms . Results : Principal-component analysis of all scale scores revealed 2 distinct components , explaining 53 % of the total variance . One component was characterized by psychological symptoms and generic quality of life indicators , whilst the other component was made up of physical symptoms , social and physical functioning and indicators of fatigue . Conclusions : The findings suggest that perceived functional incapacity is a primary characteristic of CFS , which is manifested and /or explained by physical symptoms",
"OBJECTIVE Changes in physical activity are thought to play an important role in maintaining symptoms in chronic fatigue syndrome ( CFS ) . The aim of this study was to describe intraindividual physical activity patterns in more detail and to identify pervasively passive patients . METHODS With help of a movement-sensing device , physical activity levels were registered continuously over a 12-day period in 277 CFS patients . Within this registration period , the 10 largest activity peaks were computed . The intensity and duration of these activity peaks and their subsequent rest periods were described and compared to those of 47 healthy controls . In addition , the patients ' 12 daily activity scores were used to identify patients who were characterised by low levels of physical activity throughout the registration period . RESULTS The CFS sample had less intense and shorter activity peaks , while the average rest periods that followed these peaks lasted longer . Approximately one-fourth of the CFS sample differed distinctly from the control group and was labelled as pervasively passive . CONCLUSION The measurements and classification of actual physical activity levels were found to reduce heterogeneity in the CFS population and therefore could provide the opportunity to optimise behavioural intervention protocol s for CFS",
"The relationship of sleep complaints to mood , fatigue , disability , and lifestyle was examined in 69 chronic fatigue syndrome ( CFS ) patients without psychiatric disorder , 58 CFS patients with psychiatric disorder , 38 psychiatric out- patients with chronic depressive disorders , and 45 healthy controls . The groups were matched for age and gender . There were few differences between the prevalence or nature of sleep complaints of CFS patients with or without current DSM-IIIR depression , anxiety or somatization disorder . CFS patients reported significantly more naps and waking by pain , a similar prevalence of difficulties in maintaining sleep , and significantly less difficulty getting off to sleep compared to depressed patients . Sleep continuity complaints preceded fatigue in only 20 % of CFS patients , but there was a strong association between relapse and sleep disturbance . Certain types of sleep disorder were associated with increased disability or fatigue in CFS patients . Disrupted sleep appears to complicate the course of CFS . For the most part , sleep complaints are either attributable to the lifestyle of CFS patients or seem inherent to the underlying condition of CFS . They are generally unrelated to depression or anxiety in CFS",
"The study aim ed to 1 ) examine the point prevalence of asynchronous breathing in chronic fatigue syndrome ( CFS ) patients ; 2 ) examine whether CFS patients with an asynchronous breathing pattern present with diminished lung function in comparison with CFS patients with a synchronous breathing pattern ; and 3 ) examine whether one session of breathing retraining in CFS patients with an asynchronous breathing pattern is able to improve lung function . Twenty patients fulfilling the diagnostic criteria for CFS were recruited for participation in a pilot controlled clinical trial with repeated measures . Patients presenting with an asynchronous breathing pattern were given 20–30 minutes of breathing retraining . Patients presenting with a synchronous breathing pattern entered the control group and received no intervention . Of the 20 enrolled patients with CFS , 15 presented with a synchronous breathing pattern and the remaining 5 patients ( 25 % ) with an asynchronous breathing pattern . Baseline comparison revealed no group differences in demographic features , symptom severity , respiratory muscle strength , or pulmonary function testing data ( spirometry ) . In comparison to no treatment , the session of breathing retraining result ed in an acute ( immediately postintervention ) decrease in respiratory rate ( p increase in tidal volume ( p respiratory variables responded to the session of breathing retraining . In conclusion , the present study provides preliminary evidence supportive of an asynchronous breathing pattern in a subgroup of CFS patients , and breathing retraining might be useful for improving tidal volume and respiratory rate in CFS patients presenting with an asynchronous breathing motion",
"OBJECTIVE In this r and omized noninferiority study , the effectiveness and efficiency of stepped care for chronic fatigue syndrome ( CFS ) was compared to care as usual . Stepped care was formed by guided self-instruction , followed by cognitive behavior therapy ( CBT ) if the patient desired it . Care as usual encompassed CBT after a waiting period . METHOD A total of 171 CFS patients were r and omly allocated to stepped care or care as usual . Patients in both conditions were assessed 3 times : at baseline , after guided self-instruction or the waiting period , and after CBT . The primary outcome variables were fatigue severity ( Checklist Individual Strength ) and disabilities ( Sickness Impact Profile and Medical Outcomes Survey Short Form-36 ) . RESULTS An intention to treat analysis showed that stepped care ( N = 84 ) for CFS is noninferior to care as usual ( N = 85 ) . Both conditions were equivalent in reducing fatigue severity , reducing disabilities , and increasing physical functioning . The treatment results of both conditions were in accordance with those of previous r and omized controlled trials testing the effectiveness of CBT for CFS . The total therapist time needed to treat a patient was significantly less in the stepped care condition . CONCLUSIONS Stepped care is as effective as CBT and is more time efficient for the therapist",
"OBJECTIVE To test the efficacy of a grade d aerobic exercise programme in the chronic fatigue syndrome . DESIGN R and omised controlled trial with control treatment crossover after the first follow up examination . SETTING Chronic fatigue clinic in a general hospital department of psychiatry . SUBJECTS 66 patients with the chronic fatigue syndrome who had neither a psychiatric disorder nor appreciable sleep disturbance . INTERVENTIONS R and om allocation to 12 weeks of either grade d aerobic exercise or flexibility exercises and relaxation therapy . Patients who completed the flexibility programme were invited to cross over to the exercise programme afterwards . MAIN OUTCOME MEASURE The self rated clinical global impression change score , \" very much better \" or \" much better \" being considered as clinical ly important . RESULTS Four patients receiving exercise and three receiving flexibility treatment dropped out before completion . 15 of 29 patients rated themselves as better after completing exercise treatment compared with eight of 30 patients who completed flexibility treatment . Analysis by intention to treat gave similar results ( 17/33 v 9/33 patients better ) . Fatigue , functional capacity , and fitness were significantly better after exercise than after flexibility treatment . 12 of 22 patients who crossed over to exercise after flexibility treatment rated themselves as better after completing exercise treatment 32 of 47 patients rated themselves as better three months after completing supervised exercise treatment 35 of 47 patients rated themselves as better one year after completing supervised exercise treatment . CONCLUSION These findings support the use of appropriately prescribed grade d aerobic exercise in the management of patients with the chronic fatigue syndrome",
"BACKGROUND Cognitive behaviour therapy ( CBT ) for chronic fatigue syndrome ( CFS ) is an effective but intensive treatment , requiring trained therapists . A minimal intervention based on CBT for CFS , guided self-instruction , was shown to be an effective treatment when delivered in a tertiary treatment centre . Implementing this intervention in a community-based mental health centre ( MHC ) will increase the treatment capacity for CFS patients . This study evaluated the effectiveness of guided self-instruction for CFS implemented in an MHC , delivered by nurses . METHOD One hundred and twenty-three patients were r and omly assigned to either guided self-instruction ( n=62 ) or a waiting list ( n=61 ) . R and omization was computer generated , with allocation by numbered sealed envelopes . Group allocation was open to all those involved . Patients fulfilled US Centers for Disease Control and Prevention ( CDC ) criteria for CFS . Primary outcome variables were fatigue severity and physical and social functioning , measured with the Checklist Individual Strength ( CIS ) and the Medical Outcomes Survey Short Form-36 ( SF-36 ) respectively . RESULTS After 6 months , patients who followed guided self-instruction reported a significantly larger decrease in fatigue compared to the waiting list [ mean difference -8.1 , 95 % confidence interval ( CI ) -3.8 to -12.4 , controlled effect size 0.70 ] . There was no significant difference in physical and social functioning . However , post-hoc analyses showed a significant decrease in fatigue and physical disabilities following the intervention in a subgroup of patients with physical disabilities at baseline ( SF-36 physical functioning ⩽70 ) . CONCLUSIONS Implementation of guided self-instruction in a community-based MHC was partially successful . The minimal intervention can be effectively implemented for CFS patients with physical impairments",
"OBJECTIVES To test the hypothesis that group cognitive behavioural therapy ( CBT ) will produce an effective and cost-effective management strategy for patients in primary care with chronic fatigue syndrome/myalgic encephalopathy ( CFS/ME ) . DESIGN A double-blind , r and omised controlled trial was adopted with three arms . Outcomes were assessed at baseline and 6 and 12 months after first assessment and results were analysed on an intention-to-treat basis . SETTING A health psychology department for the management of chronic illness in a general hospital in Bristol , UK . PARTICIPANTS Adults with a diagnosis of CFS/ME referred by their GP . INTERVENTIONS The three interventions were group CBT incorporating grade d activity scheduling , education and support group ( EAS ) and st and ard medical care ( SMC ) . OUTCOME MEASURES The primary outcome measure was the Short Form with 36 Items ( SF-36 ) physical and mental health summary scales . Other outcome measures included the Chalder fatigue scale , Hospital Anxiety and Depression Scale , General Health Question naire , physical function ( shuttles walked , walking speed and perceived fatigue ) , health utilities index and cognitive function ( mood , recall and reaction times ) . RESULTS A total of 153 patients were recruited to the trial and 52 were r and omised to receive CBT , 50 to EAS and 51 to SMC . Twelve patients failed to attend for the 12-month follow-up and 19 patients attended one follow-up , but not both . The sample was found to be representative of the patient group and the characteristics of the three groups were similar at baseline . Three outcome measures , SF-36 mental health score , Chalder fatigue scale and walking speed , showed statistically significant differences between the groups . Patients in the CBT group had significantly higher mental health scores [ difference + 4.35 , 95 % confidence interval ( CI ) + 0.72 to + 7.97 , p = 0.019 ] , less fatigue ( difference -2.61 , 95 % CI -4.92 to -0.30 , p = 0.027 ) and were able to walk faster ( difference + 2.83 shuttles , 95 % CI + 1.12 to + 5.53 , p = 0.0013 ) than patients in the SMC group . CBT patients also walked faster and were less fatigued than those r and omised to EAS ( walking speed : difference + 1.77 , 95 % CI + 0.025 to + 3.51 , p = 0.047 ; fatigue : difference -3.16 , 95 % CI -5.59 to -0.74 , p = 0.011 ) . Overall , no other statistically significant difference across the groups was found , although for many measures a trend towards an improved outcome with CBT was seen . Except for walking speed , which , on average , increased by + 0.87 shuttles ( 95 % CI + 0.09 to + 1.65 , p = 0.029 ) between the 6- and 12-month follow-ups , the scores were similar at 6 and 12 months . At baseline , 30 % of patients had an SF-36 physical score within the normal range and 52 % had an SF-36 mental health score in the normal range . At 12 months , the physical score was in the normal range for 46 % of the CBT group , 26 % of the EAS group and 44 % of SMC patients . For mental health score the percentages were CBT 74 % , EAS 67 % and SMC 70 % . Of the CBT group , 32 % showed at least a 15 % increase in physical function and 64 % achieved a similar improvement in their mental health . For the EAS and SMC groups , this improvement in physical and mental health was achieved for 40 and 60 % ( EAS ) and 49 and 53 % ( SMC ) , respectively . The cost-effectiveness of the intervention proved very difficult to assess and did not yield reliable conclusions . CONCLUSIONS Group CBT did not achieve the expected change in the primary outcome measure as a significant number did not achieve scores within the normal range post-intervention . The treatment did not return a significant number of subjects to within the normal range on this domain ; however , significant improvements were evident in some areas . Group CBT was effective in treating symptoms of fatigue , mood and physical fitness in CFS/ME . It was found to be as effective as trials using individual therapy in these domains . However , it did not bring about improvement in cognitive function or quality of life . There was also evidence of improvement in the EAS group , which indicates that there is limited value in the non-specific effects of therapy . Further research is needed to develop better outcome measures , assessment s of the broader costs of the illness and a clearer picture of the characteristics best fitted to this type of intervention",
"OBJECTIVES To investigate aspects of the validity of the total scores of the Tampa Scale for Kinesiophobia ( TSK ) , Dutch Version , which was modified to make it an appropriate question naire for the assessment of kinesiophobia ( fear of movement ) in chronic fatigue syndrome ( CFS ) patients ( the Dutch TSK-CFS ) , and , using this assessment tool , to examine the associations between kinesiophobia , exercise capacity , and activity limitations and participation restrictions in patients with CFS . DESIGN Prospect i ve observational studies . SETTING An outpatient fatigue clinic . PARTICIPANTS In the first study , 40 patients fulfilling the 1994 US Centers for Disease Control and Prevention ( CDC ) criteria for CFS were enrolled . The sample of the second study consisted of 51 CDC-defined patients with CSF . INTERVENTIONS Not applicable . Main outcome measures Study 1 : Subjects completed a set of question naires ; the Utrechtse Coping List ( UCL ) , the Dutch TSK-CFS , and the Dutch Baecke Question naire of Habitual Physical Activity . Study 2 : All patients completed 2 question naires ( Chronic Fatigue Syndrome Activities and Participation Question naire [ CFS-APQ ] , Dutch TSK-CFS ) and performed a maximal exercise stress test on a bicycle ergometer . The heart rate was monitored continuously by use of an electrocardiograph . Metabolic and ventilatory parameters were measured through spirometry . RESULTS Study 1 : The Cronbach alpha coefficient for the individual item scores on the TSK-CFS was .80 . The total scores on the Dutch TSK-CFS showed a statistically significant correlation with both the avoidance/abide subscale of the UCL ( Spearman rho=.35 , P=.029 ) and the total score of the Baecke Question naire ( rho=-.45 , P=.004 ) . Study 2 : The total scores on the Dutch TSK-CFS showed a statistically significant correlation with the total scores on the CFS-APQ ( rho=.39 , P=.004 ) . No statistically significant associations were observed between the exercise capacity parameters and the total scores on the Dutch TSK-CFS . CONCLUSIONS These results provide evidence for the internal consistency and the convergent and congruent validity of the scores obtained by use of the Dutch TSK-CFS . Kinesiophobia appears to be associated with activity limitations /participation restrictions but not with exercise capacity in patients with CFS"
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To the Editor : The same patient outcome data from clinical trial results , when presented as absolute or relative changes , may appear different in magnitude . Recommendations are to report both absolute and relative , or at least baseline , data from which to calculate absolute values [ 1 , 2 ] . A systematic review of efficacy trials demonstrated that only relative values were reported in most study abstract s ( 88 % ) and the main text ( 75 % ) [ 3 ] . To inform clinical practice , outcome improvements , whether relative or absolute , must be statistically significant and clinical ly meaningful . A minimal clinical ly important difference ( MCID ) should inform sample size calculations for clinical trials . Two main methods identify an MCID ( distribution and anchor-based methods ) ; ideally used together to interpret one in the context of the other [ 4 ] . The distribution method is a statistical calculation based on the baseline variability of the measure in the population studied . This gives an effect size ( change after intervention divided by st and ard deviation of baseline scores ) , the magnitude of which relates to a small , moderate or large clinical effect [ 5 ] . Thus the distribution method can only be used to calculate an absolute MCID as there is no st and ard deviation of baseline score for a relative measure . The anchor-based method relates the change in
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"The role of inhaled corticosteroids in the management of chronic obstructive pulmonary disease ( COPD ) remains controversial . The purpose of this study was to evaluate whether sputum eosinophilia ( defined as eosinophils ≥3 % ) predicts clinical benefit from inhaled corticosteroid treatment in patients with smoking-related clinical ly stable moderate-to-severe COPD . Forty consecutive patients with effort dyspnoea ( mean age 67 yrs ; 52 pack-yr smoking history ; post-bronchodilator forced expiratory volume in one second ( FEV1 ) Subjects were treated with inhaled placebo followed by inhaled budesonide ( Pulmicort Turbuhaler ® 1,600 µg·day−1 ) , each given for 4 weeks . While the treatment was single-blind ( subject level ) , sputum cell counts before and after treatment interventions were double-blind , thus removing bias . Outcome variables included spirometry , quality -of-life assessment and 6-min walk test . Sputum eosinophilia was present in 38 % of subjects . In these , budesonide treatment normalised the eosinophil counts and , in comparison to placebo treatment , result ed in clinical ly significant improvement in the dyspnoea domain of the disease-specific chronic respiratory question naire ( 0.8 versus 0.3 ) and a small but statistically significant improvement in post-bronchodilator spirometry ( FEV1 100 mL versus 0 mL ; p , sputum eosinophilia predicts short-term clinical benefit from high-dose inhaled corticosteroid treatment in patients with stable moderate-to-severe chronic obstructive pulmonary disease",
"& NA ; Pain intensity is frequently measured on an 11‐point pain intensity numerical rating scale ( PI‐NRS ) , where 0=no pain and 10=worst possible pain . However , it is difficult to interpret the clinical importance of changes from baseline on this scale ( such as a 1‐ or 2‐point change ) . To date , there are no data driven estimates for clinical ly important differences in pain intensity scales used for chronic pain studies . We have estimated a clinical ly important difference on this scale by relating it to global assessment s of change in multiple studies of chronic pain . Data on 2724 subjects from 10 recently completed placebo‐controlled clinical trials of pregabalin in diabetic neuropathy , postherpetic neuralgia , chronic low back pain , fibromyalgia , and osteoarthritis were used . The studies had similar design s and measurement instruments , including the PI‐NRS , collected in a daily diary , and the st and ard seven‐point patient global impression of change ( PGIC ) , collected at the endpoint . The changes in the PI‐NRS from baseline to the endpoint were compared to the PGIC for each subject . Categories of ‘ much improved ’ and ‘ very much improved ’ were used as determinants of a clinical ly important difference and the relationship to the PI‐NRS was explored using graphs , box plots , and sensitivity/specificity analyses . A consistent relationship between the change in PI‐NRS and the PGIC was demonstrated regardless of study , disease type , age , sex , study result , or treatment group . On average , a reduction of approximately two points or a reduction of approximately 30 % in the PI‐NRS represented a clinical ly important difference . The relationship between percent change and the PGIC was also consistent regardless of baseline pain , while higher baseline scores required larger raw changes to represent a clinical ly important difference . The application of these results to future studies may provide a st and ard definition of clinical ly important improvement in clinical trials of chronic pain therapies . Use of a st and ard outcome across chronic pain studies would greatly enhance the comparability , validity , and clinical applicability of these studies",
"RATIONALE Exacerbations of chronic obstructive pulmonary disease ( COPD ) and responses to treatment are heterogeneous . OBJECTIVES Investigate the usefulness of blood eosinophils to direct corticosteroid therapy during exacerbations . METHODS Subjects with COPD exacerbations were entered into a r and omized biomarker-directed double-blind corticosteroid versus st and ard therapy study . Subjects in the st and ard arm received prednisolone for 2 weeks , whereas in the biomarker-directed arm , prednisolone or matching placebo was given according to the blood eosinophil count biomarker . Both study groups received antibiotics . Blood eosinophils were measured in the biomarker-directed and st and ard therapy arms to define biomarker-positive and -negative exacerbations ( blood eosinophil count > and ≤ 2 % , respectively ) . The primary outcome was to determine noninferiority in health status using the chronic respiratory question naire ( CRQ ) and in the proportion of exacerbations associated with a treatment failure between subjects allocated to the biomarker-directed and st and ard therapy arms . MEASUREMENTS AND MAIN RESULTS There were 86 and 80 exacerbations in the biomarker-directed and st and ard treatment groups , respectively . In the biomarker-directed group , 49 % of the exacerbations were not treated with prednisolone . CRQ improvement after treatment in the st and ard and biomarker-directed therapy groups was similar ( 0.8 vs. 1.1 ; mean difference , 0.3 ; 95 % confidence interval , 0.0 - 0.6 ; P = 0.05 ) . There was a greater improvement in CRQ in biomarker-negative exacerbations given placebo compared with those given prednisolone ( mean difference , 0.45 ; 95 % confidence interval , 0.01 - 0.90 ; P = 0.04 ) . In biomarker-negative exacerbations , treatment failures occurred in 15 % given prednisolone and 2 % of those given placebo ( P = 0.04 ) . CONCLUSIONS The peripheral blood eosinophil count is a promising biomarker to direct corticosteroid therapy during COPD exacerbations , but larger studies are required",
"Abstract Objective To determine the efficacy of oral morphine in relieving the sensation of breathlessness in patients in whom the underlying aetiology is maximally treated . Design R and omised , double blind , placebo controlled crossover study . Setting Four outpatient clinics at a hospital in South Australia . Participants 48 participants who had not previously been treated with opioids ( mean age 76 , SD 5 ) with predominantly chronic obstructive pulmonary disease ( 42 , 88 % ) were r and omised to four days of 20 mg oral morphine with sustained release followed by four days of identically formulated placebo , or vice versa . Laxatives were provided as needed . Main outcome measures Dyspnoea in the morning and evening as shown on a 100 mm visual analogue scale , quality of sleep , wellbeing , performance on physical exertion , and side effects as measured at the end of the four day treatment period . Results 38 participants completed the study ; three withdrew because of definite and two because of possible side effects of morphine ( nausea , vomiting , and sedation ) . Participants reported significantly different dyspnoea scores when treated with morphine : an improvement of 6.6 mm ( 95 % confidence interval 1.6 mm to 11.6 mm ) in the morning and of 9.5 mm ( 3.0 mm to 16.1 mm ) in the evening ( P = 0.011 and P = 0.006 , respectively ) . During the period in which they were taking morphine participants also reported better sleep ( P = 0.039 ) . More participants reported distressing constipation while taking morphine ( 9 v 1 , P = 0.021 ) in spite of using laxatives . All other side effects were not significantly worse with morphine , although the study was not powered to address side effects . Conclusions Sustained release , oral morphine at low dosage provides significant symptomatic improvement in refractory dyspnoea in the community setting",
"Background There is a need for biomarkers to better characterise individuals with COPD and to aid with the development of therapeutic interventions . A panel of putative blood biomarkers was assessed in a subgroup of the Evaluation of COPD Longitudinally to Identify Surrogate Endpoints ( ECLIPSE ) cohort . Methods Thirty-four blood biomarkers were assessed in 201 subjects with COPD , 37 ex-smoker controls with normal lung function and 37 healthy non-smokers selected from the ECLIPSE cohort . Biomarker repeatability was assessed using baseline and 3-month sample s. Intergroup comparisons were made using analysis of variance , repeatability was assessed through Bl and -Altman plots , and correlations between biomarkers and clinical characteristics were assessed using Spearman correlation coefficients . Results Fifteen biomarkers were significantly different in individuals with COPD when compared to former or non-smoker controls . Some biomarkers , including tumor necrosis factor-α and interferon-γ , were measurable in only a minority of subjects whilst others such as C-reactive protein showed wide variability over the 3-month replication period . Fibrinogen was the most repeatable biomarker and exhibited a weak correlation with 6-minute walk distance , exacerbation rate , BODE index and MRC dyspnoea score in COPD subjects . 33 % ( 66/201 ) of the COPD subjects reported at least 1 exacerbation over the 3 month study with 18 % ( 36/201 ) reporting the exacerbation within 30 days of the 3-month visit . CRP , fibrinogen interleukin-6 and surfactant protein-D were significantly elevated in those COPD subjects with exacerbations within 30 days of the 3-month visit compared with those individuals that did not exacerbate or whose exacerbations had resolved . Conclusions Only a few of the biomarkers assessed may be useful in diagnosis or management of COPD where the diagnosis is based on airflow obstruction ( GOLD ) . Further analysis of more promising biomarkers may reveal utility in subsets of patients . Fibrinogen in particular has emerged as a potentially useful biomarker from this cohort and requires further investigation . Trial Registration SCO104960 , clinical trials.gov identifier",
"CONTEXT Clinical ly important differences in chronic refractory breathlessness are ill defined but important in clinical practice and trial design . OBJECTIVES To estimate the clinical relevance of differences in breathlessness intensity using distribution and patient anchor methods . METHODS This was a retrospective data analysis from 213 data sets from four clinical trials for refractory breathlessness . Linear regression was used to explore the relationship between study effect size and change in breathlessness score ( 0 - 100 mm visual analogue scale ) and to estimate the change in score equivalent to small , moderate , and large effect sizes . Pooled individual blinded patient preference data from three r and omized controlled trials were analyzed . The difference between the mean change in Day 4 minus baseline scores between preferred and non-preferred arms was calculated . RESULTS There was a strong relationship between change in score and effect size ( P = 0.001 ; R(2 ) = 0.98 ) . Values for small , moderate , and large effects were -5.5 , -11.3 , and -18.2 mm . The participant preference change in score was -9 mm ( 95 % CI , -15.8 , -2.1 ) ( P = 0.008 ) . CONCLUSION This larger data set supports a clinical ly important difference of 10 mm . Studies should be powered to detect this difference",
"AIMS To assess the effect of oral opioids vs. placebo on breathlessness in patients with chronic heart failure ( CHF ) . METHODS AND RESULTS Oral morphine ( Oramorph ) , oral oxycodone ( Oxynorm ) , and placebo were studied in an outpatient setting . Once r and omized , participants received all three interventions in a controlled double-blind crossover trial for 4 days each , with a 3-day washout between interventions . Patients known to the Hull and East Yorkshire Academic Cardiology department with CHF ( New York Heart Association Grade III-IV ) were invited to participate . Participants were eligible if they were on st and ard medical therapy with angiotensin-converting enzyme inhibitors/angiotensin receptor blockers , and diuretics . Participant-rated change in 11-point numerical rating scale ( NRS ) ( average over previous 24 h ) breathlessness severity score from baseline ( Day 1 ) to Day 4 of treatment was the primary outcome measure . The study was powered to detect a one-point change in severity . Thirty-nine patients were r and omized and 35 completed all three study arms . Breathlessness severity was reduced from baseline with all three interventions . There was no statistically significant difference between active intervention and placebo or between the two types of opioid for the primary endpoint [ -1.37 in NRS score for placebo group vs. -0.41 in morphine group ( P = 0.13 ) and -1.29 for oxycodone group ( P = 0.90 ) ] . The response to treatment was not affected by aetiology , severity of CHF , or concurrent drug therapy . Opioid administration did not cause detrimental changes in clinical observations and was well tolerated . CONCLUSION We demonstrated no benefit over placebo for the relief of breathlessness with short-term low-dose oral opioids for CHF patients . Trial registered prior to the recruitment of the first participant with Current Controlled Trials ( www.controlled-trials.com ; Trial number IS RCT N 85268059 )",
"Evidence suggests that eosinophilic airway inflammation is important in the pathogenesis of severe chronic obstructive pulmonary disease ( COPD ) exacerbations . The present authors tested the hypothesis that a management strategy that aims to reduce sputum eosinophil counts is associated with a reduction in exacerbations of COPD . A total of 82 patients with COPD were r and omised into two groups . One group was treated according to traditional guidelines ( British Thoracic Society ( BTS ) group ) and the other ( sputum group ) was treated with the additional aim of minimising eosinophilic airway inflammation , assessed using the induced sputum eosinophil count . The primary outcome was exacerbations , which were categorised as mild , moderate or severe . The frequency of severe exacerbations per patient per year was 0.5 and 0.2 in the BTS and sputum groups , respectively ( mean reduction 62 % ) . The majority of this benefit was confined to patients with eosinophilic airway inflammation . There was no difference in the frequency of mild and moderate exacerbations . The average daily dose of inhaled or oral corticosteroids during the trial did not differ between the groups . Out of 42 patients in the sputum group , 17 required regular oral corticosteroids to minimise eosinophilic airway inflammation . A management strategy that aims to minimise eosinophilic airway inflammation , as well as symptoms , is associated with a reduction in severe exacerbations of chronic obstructive pulmonary disease",
"BACKGROUND Some patients with chronic obstructive pulmonary disease ( COPD ) respond to corticosteroid therapy . Whether these patients have different airway pathology from other COPD patients is unclear . We tested the hypothesis that response to prednisolone is related to the presence of eosinophilic airway inflammation . METHODS We did a r and omised , double-blind , crossover trial . Patients who had COPD treated with bronchodilators only were assigned placebo and 30 mg prednisolone daily for 2 weeks each , in a r and om order , separated by a 4-week washout period . Before and after each treatment period , we assessed patients with spirometry , symptom scores , the chronic respiratory disease question naire ( CRQ ) , incremental shuttle walk test , and induced sputum . Analysis was done by intention to treat . FINDINGS 83 patients were recruited , of whom 67 were r and omised . The geometric mean sputum eosinophil count fell significantly after prednisolone ( from 2.4 % to 0.4 % ; mean difference six-fold [ 95 % CI 3.1 - 11.4 ] ) but not after placebo . Other sputum cell counts did not change . After stratification into tertiles by baseline eosinophil count , postbronchodilator forced expiratory volume in 1 s ( FEV1 ) and total scores on the CRQ improved progressively after prednisolone from the lowest to the highest eosinophilic tertile , compared with placebo . The mean change in postbronchodilator FEV1 , total CRQ score , and shuttle walk distance with prednisolone compared with placebo in the highest tertile was 0.19 L ( 0.06 - 0.32 ) , 0.62 ( 0.31 - 0.93 ) , and 20 m ( 5 - 35 ) , respectively . INTERPRETATION Our findings suggest that eosinophilic airway inflammation contributes to airflow obstruction and symptoms in some patients with COPD and that the short-term effects of prednisolone are due to modification of this feature of the inflammatory response . The possibility that sputum eosinophilia identifies a subgroup of patients who particularly respond to long-term treatment with inhaled corticosteroids should be investigated",
"Chronic heart failure ( CHF ) patients can experience significant breathlessness despite maximum medication for their heart failure . Morphine has long been used to relieve symptoms in acute failure , but there is little evidence about this potentially useful palliative therapy in CHF",
"CONTEXT R and omized controlled trials can answer questions of efficacy , but long-term pharmacovigilance studies generate complementary safety data . OBJECTIVES Level I evidence supports short-term efficacy of opioids in reducing chronic refractory dyspnea . This study aim ed to determine the minimum effective once-daily dose of sustained-release morphine , and whether net clinical benefits are sustained safely . METHODS In a Phase II dose increment study , 10 mg daily of sustained-release morphine was administered , and increased in nonresponders by 10 mg daily each week to a maximum of 30 mg daily . The participant was withdrawn if there were unacceptable side effects or no response to maximum dose . If participants had a 10 % improvement in dyspnea over their own baseline , they joined a long-term Phase IV effectiveness/safety study at that dose . Complying with Strengthening the Reporting of Observational Studies in Epidemiology ( STROBE ) guidelines , response and side effects are described , with demographic and clinical characteristics of responders . RESULTS Eighty-three participants ( 53 males , mean age 75 years , 54 % with chronic obstructive pulmonary disease ) provided more than 30 patient-years of data . Fifty-two participants derived ≥ 10 % benefit ( on average 35 % improvement over baseline ) , giving a response rate of 62 % ( number needed to treat of 1.6 : number needed to harm 4.6 ) ; for 70 % , this dose was 10mg/24h . Benefit was maintained at three months for 28 ( 33 % ) people . Ranking of breathlessness was reduced significantly ( P but constipation increased ( P episodes of respiratory depression or hospitalizations as a result of the sustained-release morphine . Overall , one in three people continued to derive benefit at three months . CONCLUSION Ten milligrams of sustained-release oral morphine once daily is safe and effective for most people who respond",
"CONTEXT Dyspnea is a disabling distressing symptom that is common in advanced disease affecting millions of people worldwide . Current palliative strategies are partially effective in managing this symptom ; facial cooling has been shown to reduce the sensation of breathlessness when induced in volunteers but has not been formally investigated in dyspnea associated with disease . OBJECTIVE The objective of this study was to investigate whether a h and held fan reduces the sensation of breathlessness in such patients , enhancing palliative approaches . METHODS The effectiveness of a h and held fan ( blowing air across the nose and mouth ) in reducing the sensation of breathlessness was assessed in patients with advanced disease . Fifty participants were r and omized to use a h and held fan for five minutes directed to their face or leg first and then crossed over to the other treatment . The primary outcome measure was a decrease of greater than 1 cm in breathlessness recorded on a 10 cm visual analog scale ( VAS ) . RESULTS There was a significant difference in the VAS scores between the two treatments , with a reduction in breathlessness when the fan was directed to the face ( P=0.003 ) . CONCLUSION This study supports the hypothesis that a h and held fan directed to the face reduces the sensation of breathlessness . The fan was acceptable to participants : it is inexpensive , portable , enhances self-efficacy , and available internationally . It should be recommended as part of a palliative management strategy for reducing breathlessness associated with advanced disease",
"A reliable predictor of benefit from corticosteroid treatment in patients with chronic airflow limitation is needed . In a single-blind , sequential crossover trial of placebo and prednisone ( 30 mg/day ) treatment , with each given for 2 wk , we investigated whether an increased proportion of sputum eosinophils ( > = 3 % ) predicts a beneficial effect of prednisone in smokers with severe obstructive bronchitis . Patients were seen before and after each treatment . Clinical measurements were made blind to the laboratory findings and vice-versa . Eighteen of 20 patients completed the study . Eight had sputum eosinophilia and similar clinical and physiologic characteristics to those of 10 patients without a finding of sputum eosinophilia . Only in patients with sputum eosinophilia did prednisone , as compared with placebo , produce a statistically significant and clinical ly important mean effect on effort dyspnea of 0.8 ( 95 % confidence interval [ CI ] : 0.3 to 1.2 ) , p = 0.008 , and in quality of life of 1.96 ( 95 % CI : 0.5 to 3.3 ) , p = 0.01 , associated with a small improvement in FEV1 of 0.11 L ( 95 % CI : - 0.04 to 0.23 L ) , p = 0.05 . In these patients , prednisone also produced a significant decline in the median sputum eosinophil percentage , from 9.7 % to 0.5 % ( p = 0.002 ) , eosinophil cationic protein ( ECP ) , from 6 , 000 microgram/L to 1,140 microgram/L ( p smokers with severe airflow limitation , sputum eosinophilia predicts a beneficial effect of prednisone treatment . Improvement in FEV1 , after prednisone treatment in this population , is small , and may not be appreciated in clinical practice"
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Background and Aims Ezetimibe reduces plasma low-density lipoprotein cholesterol ( LDL-C ) levels by up to 20 % . However , its effect on plasma lipoprotein(a ) [ Lp(a ) ] concentrations in patients with primary hypercholesterolemia has not been defined . Objective Therefore , we performed a systematic review and meta- analysis to assess this effect based on the available r and omized controlled trials ( RCTs ) . Methods We search ed the PubMed and SCOPUS data bases from inception until 28 February 2017 to identify RCTs that investigated the effect of ezetimibe monotherapy on plasma Lp(a ) concentrations in patients with primary hypercholesterolemia . We pooled mean percentage changes in plasma Lp(a ) concentrations as a mean difference ( MD ) with a 95 % confidence interval ( CI ) . Results Seven RCTs with 2337 patients met the selection criteria and were included in the analysis . Overall pooled analysis suggested that ezetimibe 10 mg significantly reduced plasma Lp(a ) concentrations in patients with primary hypercholesterolemia by − 7.06 % ( 95 % CI − 11.95 to − 2.18 ; p = 0.005 ) compared with placebo . No significant heterogeneity was observed ( χ2 = 5.34 ; p = 0.5 ) . Excluding one study from the analysis result ed in insignificant differences between the two groups ( p = 0.2 ) . Meta-regression did not find a significant association between the mean percentage changes in Lp(a ) and other potential moderator variables , which included the mean percentage changes of LDL-C concentrations ( p = 0.06 ) and baseline Lp(a ) mean values ( p = 0.46 ) . Conclusions Ezetimibe monotherapy ( 10 mg/day ) showed a small ( 7.06 % ) but statistically significant reduction in the plasma levels of Lp(a ) in patients with primary hypercholesterolemia . According to current literature , this magnitude of reduction seems to have no clinical relevance . However , further studies are warranted to clarify the mechanism mediating this effect of ezetimibe and to investigate its efficacy in combination with other drugs that have shown promise in lowering Lp(a ) levels
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"Elevated lipoprotein(a ) [ Lp(a ) ] is independently associated with increased cardiovascular risk . However , treatment options for elevated Lp(a ) are limited . Alirocumab , a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 , reduced low-density lipoprotein cholesterol ( LDL-C ) by up to 62 % from baseline in phase 3 studies , with adverse event rates similar between alirocumab and controls . We evaluated the effect of alirocumab on serum Lp(a ) using pooled data from the phase 3 ODYSSEY program : 4,915 patients with hypercholesterolemia from 10 phase 3 studies were included . Eight studies evaluated alirocumab 75 mg every 2 weeks ( Q2W ) , with possible increase to 150 mg Q2W at week 12 depending on LDL-C at week 8 ( 75/150 mg Q2W ) ; the other 2 studies evaluated alirocumab 150-mg Q2W from the outset . Comparators were placebo or ezetimibe . Eight studies were conducted on a background of statins , and 2 studies were carried out with no statins . Alirocumab was associated with significant reductions in Lp(a ) , regardless of starting dose and use of concomitant statins . At week 24 , reductions from baseline were 23 % to 27 % with alirocumab 75/150-mg Q2W and 29 % with alirocumab 150-mg Q2W ( all comparisons p Lp(a ) reductions with alirocumab were independent of race , gender , presence of familial hypercholesterolemia , baseline Lp(a ) , and LDL-C concentrations , or use of statins . In conclusion , in addition to marked reduction in LDL-C , alirocumab leads to a significant and sustained lowering of Lp(a )",
"Background Ezetimibe , as a cholesterol absorption inhibitor , has been shown protecting against atherosclerosis when combined with statin . However , side by side comparison has not been made to evaluate the beneficial effects of ezetimibe alone versus statin . Herein , the study aim ed to test whether ezetimibe alone would exhibit similar effects as statin and the combination therapy would be necessary in a moderate lesion size . Methods and Results ApoE-/- male mice that were fed a saturated-fat supplemented diet were r and omly assigned to different therapeutic regimens : vehicle , ezetimibe alone ( 10 mg/kg/day ) , atorvastatin ( 20 mg/kg/day ) or combination of ezetimibe and atorvastatin through the drinking water . On 28 days , mice were sacrificed and aorta and sera were collected to analyze the atherosclerotic lesion and blood lipid and cholesterol levels . As a result , ezetimibe alone exerted similar protective effects on atherosclerotic lesion sizes as atorvastatin , which was mediated by lowering serum cholesterol concentrations , inhibiting macrophage accumulation in the lesions and reducing circulatory inflammatory cytokines , such as monocyte chemoattractant protein ( MCP-1 ) and tumor necrosis factor ( TNF-α ) . In contrast to ezetimibe administration , atorvastatin alone attenuated atherosclerotic lesion which is dependent on its anti-inflammation effects . There were no significance differences in lesion areas and serum concentrations of cholesterol , oxidized LDL and inflammatory cytokines between combination therapy and monotherapy ( either ezetimibe or atorvastatin ) . There were significant correlations between the lesion areas and serum concentrations of cholesterol , MCP-1 and TNF-α , respectively . However , there were no significant correlations between the lesion areas and serum concentrations of TGF-β1 and oxLDL . Conclusions Ezetimibe alone played the same protection against a moderate atherosclerotic lesion as atorvastatin , which was associated with lowering serum cholesterol , decreasing circulating inflammatory cytokines , and inhibiting macrophage accumulation in the lesions",
"Ezetimibe , a cholesterol absorption inhibitor , can be combined with statins to lower LDL-cholesterol . We evaluated additional ezetimibe ( 10 mg/day ) in a placebo-controlled , double blind , r and omized cross-over study in 20 patients ( age 56+/-9 years , m : f 10:10 , BMI 27.5+/-4.0 kg/m(2 ) ) suffering from severe hypercholesterolemia and CHD who were treated by statins and regular LDL-apheresis . Lipoproteins ( cholesterol , triglycerides , LDL-cholesterol , HDL-cholesterol , VLDL-cholesterol , VLDL-triglycerides , lipoprotein(a ) ) were determined twice ( before and during ezetimibe/placebo , each given for 5 weeks ) , dietary behaviour was analyzed once ( 3-days- protocol ) during each treatment period . During ezetimibe the mean ( + /-S.D. ) preapheresis LDL-cholesterol concentration decreased from 159+/-26 mg/dl ( 4.11+/-0.67 mmol/l ) to 133+/-28 mg/dl ( 3.44+/-0.72 mmol/l ) ( -16+/-11 % , P postapheresis LDL-cholesterol from 51+/-9 mg/dl ( 1.32+/-0.23 mmol/l ) to 43+/-8 mg/dl ( 1.11+/-0.21 mmol/l ) ( -14+/-25 % , P placebo . Mean VLDL-cholesterol fell by 18+/-71 % ( P ezetimibe and was not significantly changed by placebo ( + 19+/-70 % ) . Furthermore , during ezetimibe less plasma volume was treated ( 3725+/-1560 versus 3870+/-1549 ml , P Ezetimibe had no effect on pre- and postapheresis triglyceride , HDL-cholesterol and lipoprotein(a ) levels . The effect of ezetimibe was independent of the statin dose . Dietary behaviour did not change and no side effects were observed . Thus , in patients with severe LDL-hypercholesterolemia and CHD the addition of ezetimibe to intensive lipid lowering therapy ( statins and LDL-apheresis ) result ed in a further , clinical ly significant decrease of LDL-cholesterol",
"Background —Despite the established efficacy of statins , many patients do not achieve recommended LDL cholesterol ( LDL-C ) goals . Contributing factors may be inadequate dosing , increased risk for adverse effects with high-dose monotherapy , and increased potential for intolerance and adverse effects with combinations of available agents . Methods and Results —In a double-blind study , 628 patients with baseline LDL-C 145 to 250 mg/dL and triglycerides ≤350 mg/dL were r and omly assigned to receive 1 of the following for 12 weeks : ezetimibe ( 10 mg/d ) ; atorvastatin ( 10 , 20 , 40 , or 80 mg/d ) ; ezetimibe ( 10 mg ) plus atorvastatin ( 10 , 20 , 40 , or 80 mg/d ) ; or placebo . The primary efficacy end point was percentage reduction in LDL-C for pooled ezetimibe plus atorvastatin versus pooled atorvastatin treatment groups . Ezetimibe plus atorvastatin significantly improved LDL-C , HDL cholesterol ( HDL-C ) , triglycerides , total cholesterol : HDL-C , and high-sensitivity C-reactive protein ( hs-CRP ) compared with atorvastatin alone ( P of ezetimibe provided a significant additional 12 % LDL-C reduction , 3 % HDL-C increase , 8 % triglyceride reduction , and 10 % hs-CRP reduction versus atorvastatin alone . Ezetimibe plus atorvastatin provided LDL-C reductions of 50 % to 60 % , triglyceride reductions of 30 % to 40 % , and HDL-C increases of 5 % to 9 % , depending on atorvastatin dose . LDL-C reductions with ezetimibe plus 10 mg atorvastatin ( 50 % ) and 80 mg atorvastatin alone ( 51 % ) were similar . Conclusions —Ezetimibe plus atorvastatin was well tolerated , with a safety profile similar to atorvastatin alone and to placebo . When coadministered with atorvastatin , ezetimibe provided significant incremental reductions in LDL-C and triglycerides and increases in HDL-C. Coadministration of ezetimibe and atorvastatin offers a well-tolerated and highly efficacious new treatment option for patients with hypercholesterolemia",
"International guidelines recommend lower target cholesterol levels and treatment of low high-density lipoprotein cholesterol ( HDL-C ) and elevated triglycerides for patients at moderately high to high coronary heart disease ( CHD ) risk . Combination therapy is often required to achieve multiple lipid treatment goals , and > or = 50 % reduction in low-density lipoprotein cholesterol ( LDL-C ) is needed in some patients to achieve aggressive LDL-C targets . In this context , we evaluated comparative effects on lipid levels of combination therapy at low to moderate doses with a statin plus extended-release niacin ( niacin ER ) , a statin plus ezetimibe , and a highly potent statin alone . This was an open-label , multicenter , 12-week study in 292 patients ( 50 % women ) who qualified for drug therapy based on number of CHD risk factors . Patients were r and omized to four parallel arms , titrated from low to moderate or high doses : atorvastatin/niacin ER , rosuvastatin/niacin ER , simvastatin/ezetimibe , or rosuvastatin alone . Baseline mean values were , for LDL-C 197 mg/dL ( 5.1 mmol/L ) , HDL-C 49 mg/dL ( 1.3 mmol/L ) , triglycerides 168 mg/dL ( 1.9 mmol/L ) . There were no significant differences among treatment groups in the change from baseline in LDL-C at pre-specified timepoints during treatment . All groups lowered LDL-C by approximately 50 % or more ( range -49 to -57 % ) , achieving mean levels of 82 - 98 mg/dL ( 2.1 - 2.5 mmol/L ) . Changes in non-HDL-C ( range -46 to -55 % ) mirrored those for LDL-C and did not differ among treatment groups . Statin/niacin ER combination regimens also increased HDL-C and large HDL ( HDL2 ) and lowered triglycerides and lipoprotein ( a ) significantly more than other regimens . No drug-related myopathy or hepatotoxicity was observed . In this study , low to moderate dose combination therapy with a statin and niacin ER provided broad control of lipids and lipoproteins independently associated with CHD",
"BACKGROUND Ezetimibe ( SCH 58235 ) is a novel cholesterol absorption inhibitor that selectively and potently blocks intestinal absorption of dietary and biliary cholesterol . OBJECTIVE Data from 2 multicenter , placebo-controlled , double-blind , r and omized , parallel-group , 12-week studies of ezetimibe were pooled to evaluate the drug 's effect on lipid parameters in patients with primary hypercholesterolemia . METHODS After dietary stabilization ( National Cholesterol Education Program Step I diet or a stricter diet ) , washout of lipid-altering drugs , and a 6-week placebo lead-in period , patients with baseline plasma low-density lipoprotein cholesterol ( LDL-C ) levels > or = 130 and were r and omized to receive either ezetimibe 0.25 , 1 , 5 , or 10 mg , or placebo administered once daily before the morning meal in study A ( dose-response study ) or ezetimibe 5 or 10 mg or placebo administered once daily before the morning meal or at bedtime in study B ( dose-regimen study ) . RESULTS A total of 432 patients were included in this pooled analysis , 243 in study A and 189 in study B. The 5- and 10-mg doses of ezetimibe significantly reduced LDL-C levels by 15.7 % and 18.5 % , respectively ( P high-density lipoprotein cholesterol ( hDL-C ) levels by 2.9 % and 3.5 % , respectively ( P plasma TG levels was observed ( P = NS ) . With the 10-mg dose of ezetimibe , 67.8 % of patients achieved > or = 15 % reduction in plasma LDL-C levels , and 22.0 % achieved > or = 25 % reduction . With the 5-mg dose , 54.0 % of patients achieved > or = 15 % reduction in plasma LDL-C levels , and 15.3 % achieved > or = 25 % reduction . The decrease in plasma LDL-C levels was significantly greater with ezetimibe 10 mg compared with ezetimibe 5 mg ( P Ezetimibe was well tolerated , with an adverse event profile similar to that of placebo . CONCLUSIONS In these two 12-week studies , ezetimibe significantly decreased plasma LDL-C levels and increased plasma HDL-C levels , with a tolerability profile similar to that of placebo",
"To assess the effects of anacetrapib added to statin ± other lipid-modifying therapies in patients with hypercholesterolemia and not at their low-density lipoprotein cholesterol ( LDL-C ) goal ( as per National Cholesterol Education Program Adult Treatment Panel III [ NCEP ATP III ] guidelines ) and in those with low high-density lipoprotein cholesterol ( HDL-C ) . Patients on a stable dose of moderate/high-intensity statin ± other lipid-modifying therapies with LDL-C ≥70 , ≥100 , ≥130 , or ≥160 mg/dl for very high , high , moderate , and low coronary heart disease risk , respectively , or at LDL-C goal with HDL-C ≤40 mg/dl , were r and omized 1:1:1 , stratified by background therapy use , to anacetrapib 100 mg ( n = 153 ) , anacetrapib 25 mg ( n = 152 ) , or placebo ( n = 154 ) for 24 weeks , followed by a 12-week off-drug reversal phase . The primary end points were percent change from baseline in LDL-C ( beta-quantification method ) and HDL-C , as well as the safety profile of anacetrapib . Both doses of anacetrapib reduced LDL-C , non-HDL-C , apolipoprotein ( Apo ) B , and lipoprotein a and increased HDL-C and Apo AI versus placebo ( p the anacetrapib 25 mg , 100 mg , and placebo groups in the proportions of discontinuations due to drug-related adverse events ( 0.7 % , 1.3 % vs 1.3 % ) or in abnormalities in liver enzymes ( 0 % , 0 % vs 0.7 % ) , creatine kinase elevations overall ( 0 % , 0.7 % vs 0 % ) or with muscle symptoms ( none seen ) , blood pressure , electrolytes , or adjudicated cardiovascular events ( 0.7 % , 0.7 % vs 1.3 % ) . In conclusion , treatment with anacetrapib result ed in substantial reductions in LDL-C and increases in HDL-C and was generally well tolerated ",
"OBJECTIVES The purpose of this study was to assess the efficacy and safety of ezetimibe administered with simvastatin in patients with primary hypercholesterolemia . BACKGROUND Despite the availability of statins , many patients do not achieve lipid targets . Combination therapy with lipid-lowering agents that act via a complementary pathway may allow additional patients to achieve recommended cholesterol goals . METHODS After dietary stabilization , a 2- to 12-week washout period , and a 4-week , single-blind , placebo lead-in period , patients with baseline low-density lipoprotein cholesterol ( LDL-C ) > or = 145 mg/dl to to one of the following 10 groups administered daily for 12 consecutive weeks : ezetimibe 10 mg ; simvastatin 10 , 20 , 40 , or 80 mg ; ezetimibe 10 mg plus simvastatin 10 , 20 , 40 , or 80 mg ; or placebo . The primary efficacy variable was percentage reduction from baseline to end point in direct LDL-C for the pooled ezetimibe plus simvastatin groups versus pooled simvastatin groups . RESULTS Ezetimibe plus simvastatin significantly improved LDL-C ( p high-density lipoprotein cholesterol ( HDL-C ) ( p = 0.03 ) , and TG ( p Ezetimibe plus simvastatin ( pooled doses ) provided an incremental 13.8 % LDL-C reduction , 2.4 % HDL-C increase , and 7.5 % TG reduction compared with pooled simvastatin alone . Coadministration of ezetimibe and simvastatin provided LDL-C reductions of 44 % to 57 % , TG reductions of 20 % to 28 % , and HDL-C increases of 8 % to 11 % , depending on the simvastatin dose . Ezetimibe 10 mg plus simvastatin 10 mg and simvastatin 80 mg alone each provided a 44 % LDL-C reduction . The coadministration of ezetimibe with simvastatin was well tolerated , with a safety profile similar to those of simvastatin and of placebo . CONCLUSIONS When coadministered with simvastatin , ezetimibe provided significant incremental reductions in LDL-C and TG , as well as increases in HDL-C. Coadministration of ezetimibe with simvastatin was well tolerated and comparable to statin alone",
"AIM Ezetimibe is a novel cholesterol absorption inhibitor that reduces the level of low-density lipoprotein (LDL)-cholesterol ( C ) . The effects of ezetimibe on remnant-like particle (RLP)-C , lipoprotein ( a ) [ Lp(a ) ] , and oxidized LDL ( Ox-LDL ) levels have not been examined . METHODS Fifty patients with dyslipidemia were treated with 10 mg/day of ezetimibe . At baseline and 12 weeks after treatment with ezetimibe , we measured the levels of RLP-C , Lp(a ) , Ox-LDL , and high-sensitivity C-reactive protein ( hs-CRP ) . RESULTS The mean levels of total cholesterol ( TC ) , LDL-C , triglycerides ( TG ) , and apolipoprotein ( apo ) B , respectively , showed a significant decrease from 229+/-39 to 191+/-37 mg/dL ( -16 % , p mean level of RLP-C and median level of hs-CRP also decreased signifi-cantly from 6.8+/-4.0 to 4.8+/-2.5 mg/dL ( -21 % , p median level of Lp(a ) decreased significantly from 14 to 10 mg/dL ( -29 % , p ezetimibe monotherapy . CONCLUSIONS Ezetimibe was effective for reducing the levels of TC , LDL-C , TG , and RLP-C. Ezeti-mibe could be a potential therapeutic option for decreasing the Lp(a ) level",
"The efficacy and safety of ezetimibe , a new cholesterol absorption inhibitor , was evaluated in this r and omized , double-blind , placebo-controlled trial of 892 patients with primary hypercholesterolemia . After > or = 2 weeks on the National Cholesterol Education Program ( NCEP ) Step I or a stricter diet and a 4- to 8-week single-blind placebo lead-in , patients with low-density lipoprotein ( LDL ) cholesterol 130 to 250 mg/dl and triglycerides were r and omized 3:1 to receive ezetimibe 10 mg or placebo orally each morning for 12 weeks . The primary efficacy end point was the percent reduction in direct plasma LDL cholesterol from baseline to end point . A total of 434 men and 458 women ( ages 18 to 85 years ) received r and omized treatment ( 666 ezetimibe 10 mg , 226 placebo ) . Demographics and baseline characteristics were similar between treatment groups . Ezetimibe significantly reduced direct LDL cholesterol by a mean of 16.9 % , compared with an increase of 0.4 % with placebo ( p ezetimibe was generally consistent across all subgroups , regardless of risk-factor status , gender , age , race , or baseline lipid profile . Ezetimibe effects on LDL cholesterol occurred early ( 2 weeks ) and persisted throughout the 12-week treatment period . Compared with placebo , ezetimibe 10 mg also significantly improved calculated LDL cholesterol , apolipoprotein B , total cholesterol , triglycerides , high-density lipoprotein ( HDL ) cholesterol , and HDL(3 ) cholesterol ( p Ezetimibe was well tolerated . There were no differences in laboratory or clinical safety parameters , or gastrointestinal , liver , or muscle side effects from that of placebo . Ezetimibe 10 mg/day is well tolerated , reduces LDL cholesterol approximately 17 % , and improves other key lipid parameters",
"OBJECTIVE To compare the efficacy and safety of 10 mg of ezetimibe coadministered with simvastatin with the safety and efficacy of simvastatin monotherapy for patients with hypercholesterolemia . PATIENTS AND METHODS This multicenter double-blind , placebo-controlled , factorial study enrolled 887 patients with hypercholesterolemia ( low-density lipoprotein cholesterol [ LDL-C ] , 145 - 250 mg/dL ; triglycerides , Patients were r and omized to 1 of 10 treatments -- placebo , ezetimibe at 10 mg/d , simvastatin at 10 , 20 , 40 , or 80 mg/d , or simvastatin at 10 , 20 , 40 , or 80 mg/d plus ezetimibe at 10 mg/d for 12 weeks . The study began March 13 , 2001 , and ended January 8 , 2002 . The primary efficacy end point was the mean percent change in LDL-C levels from baseline to study end point ( last available postbaseline LDL-C measurement ) for the pooled ezetimibe/simvastatin group vs the pooled simvastatin monotherapy group . RESULTS Coadministration of ezetimibe/simvastatin was significantly ( P simvastatin alone in reducing LDL-C levels for the pooled ezetimibe/simvastatin vs pooled simvastatin analysis and at each specific dose comparison . The decrease in LDL-C levels with coadministration of ezetimibe and the lowest dose of simvastatin , 10 mg , was similar to the decrease with the maximum dose of simvastatin , 80 mg . A significantly ( P ezetimibe/simvastatin group achieved target LDL-C levels compared with those in the monotherapy group . Treatment with ezetimibe/simvastatin also led to greater reductions in total cholesterol , triglyceride , non-high-density lipoprotein cholesterol , and apolipoprotein B levels compared with simvastatin alone ; both treatments increased high-density lipoprotein cholesterol levels similarly . The safety and tolerability profiles for the ezetimibe/simvastatin and monotherapy groups were similar . CONCLUSION Through dual inhibition of cholesterol absorption and synthesis , coadministration of ezetimibe/simvastatin offers a highly efficacious and well-tolerated lipid-lowering strategy for treating patients with primary hypercholesterolemia",
"ABSTRACT Objective : To investigate the efficacy of the cholesterol absorption inhibitor ezetimibe in patients with refractory familial hyperlipidaemia or intolerant to statin therapy . Methods : This prospect i ve study assessed the safety and efficacy of ezetimibe in 200 patients with refractory familial hyperlipidaemias not achieving a low-density-lipoprotein ( LDL ) cholesterol Results : Ezetimibe monotherapy result ed in 7 % and 11 % reductions in LDL-cholesterol and apolipoprotein B respectively . Ezetimibe-statin combination therapy reduced LDL-cholesterol by an additional 11 ± 27 % and apolipoprotein B by 11 ( + 79 to –18)% . There was a similar response between various sub-groups but a wide variation within groups with the greatest effect seen in patients under-responding to statins . The number of patients achieving the LDL‐C target of 3 mmol/L rose from 5.5 % to 18 % . Non-significant effects included a 5 ( + 78 to –470)% reduction in triglycerides , 8 ± 36 % increment in HDL‐cholesterol , 21 ( + 35 to –82)% reduction in C-reactive protein and a 1 ( + 20 to –50)% increase in alanine transaminase . No effects were seen on creatinine , creatine kinase , or insulin resistance . Fourteen patients ( 7 % ) discontinued ezetimibe : seven due to gastrointestinal side-effects , one patient developed an ezetimibe-induced hypercholesterolaemia ( × 1.5 ) , one developed ezetimibe-induced hypertriglyceridaemia ( × 7 ) and five discontinued for other reasons . Conclusion : Ezetimibe is a useful addition to statins in patients with familial hyperlipidaemias but shows a highly variable response profile",
"This multicenter , r and omized , double-blind , placebo-controlled clinical study assessed the efficacy and safety of ezetimibe administered with lovastatin in primary hypercholesterolemia . After dietary stabilization , a 2- to 12-week washout period , and a 4-week single-blind placebo lead-in period , 548 patients with low-density lipoprotein ( LDL ) cholesterol > or = 145 mg/dl ( 3.75 mmol/L ) and of the following , administered daily for 12 weeks : ezetimibe 10 mg ; lovastatin 10 , 20 , or 40 mg ; ezetimibe 10 mg plus lovastatin 10 , 20 , or 40 mg ; or placebo . The primary efficacy variable was percentage decrease in direct LDL cholesterol from baseline to end point for pooled ezetimibe plus lovastatin versus pooled lovastatin alone . Ezetimibe plus lovastatin significantly improved concentrations of LDL cholesterol , high-density lipoprotein ( HDL ) cholesterol , and triglycerides compared with lovastatin alone ( p ezetimibe provided an incremental 14 % LDL cholesterol decrease , a 5 % HDL cholesterol increase , and a 10 % decrease in triglycerides compared with pooled lovastatin alone . Ezetimibe plus lovastatin provided mean LDL cholesterol decreases of 33 % to 45 % , median triglyceride decreases of 19 % to 27 % , and mean HDL cholesterol increases of 8 % to 9 % , depending on the statin dose . The coadministration of ezetimibe 10 mg plus the starting dose of lovastatin ( 10 mg ) provided comparable efficacy to high-dose lovastatin ( 40 mg ) across the lipid profile ( LDL cholesterol , HDL cholesterol , and triglycerides ) . Ezetimibe plus lovastatin was well tolerated , with a safety profile similar to both lovastatin alone and placebo . The coadministration of ezetimibe and lovastatin may offer a new treatment option in lipid management of patients with hypercholesterolemia",
"OBJECTIVE Dyslipidemia is a risk factor for not only cardiovascular diseases ( CVD ) , but also chronic kidney disease ( CKD ) . Ezetimibe , a cholesterol absorption inhibitor , lowers cholesterol levels by inhibiting both extrinsic and intrinsic cholesterol absorption via the gastrointestinal duct . However , very few studies have examined its efficacy and safety for patients with dyslipidemia complicated with CKD . METHODS Thirty-seven dyslipidemic patients ( low density lipoprotein cholesterol ( LDL-C ) levels ≥120 mg/dL ) complicated with CKD were given ezetimibe ( 10 mg/day ) for twenty-four weeks . The efficacy and safety of the therapy , including the anti-atherosclerotic and renal protective effects , were then examined . RESULTS Significant decreases were observed in the levels of LDL-C ( 158.9 ± 26.9 mg/dL→123.0 ± 31.8 mg/dL ; p ) , remnant-like lipoprotein cholesterol ( 9.3 ± 5.3 mg/dL→7.3 ± 3.8 mg/dL ; p lipoprotein ( a ) ( 22.0 ± 16.1 mg/dL→16.4 ± 11.0 mg/dL ; p The estimated glomerular filtration rate did not change , but the urine protein to creatinine ratio decreased significantly ( 1,107.3 ± 1,454.2 mg/gCre→732.1 ± 1,237.8 mg/gCre ; p in the carotid intima media thickness , but the brachial-ankle pulse wave velocity decreased significantly ( 1,770.4 ± 590.3 cm/sec→1,702.5 ± 519.9 cm/sec ; p ) . No adverse events were observed . CONCLUSION Ezetimibe can be safely administered even to patients with CKD . The results of this study indicate that ezetimibe may provide some renal protection and suppress the complications of CVD in CKD patients",
"BACKGROUND Elevated lipoprotein(a ) ( Lp[a ] ) is a highly prevalent ( around 20 % of people ) genetic risk factor for cardiovascular disease and calcific aortic valve stenosis , but no approved specific therapy exists to substantially lower Lp(a ) concentrations . We aim ed to assess the efficacy , safety , and tolerability of two unique antisense oligonucleotides design ed to lower Lp(a ) concentrations . METHODS We did two r and omised , double-blind , placebo-controlled trials . In a phase 2 trial ( done in 13 study centres in Canada , the Netherl and s , Germany , Denmark , and the UK ) , we assessed the effect of IONIS-APO(a)Rx , an oligonucleotide targeting apolipoprotein(a ) . Participants with elevated Lp(a ) concentrations ( 125 - 437 nmol/L in cohort A ; ≥438 nmol/L in cohort B ) were r and omly assigned ( in a 1:1 ratio in cohort A and in a 4:1 ratio in cohort B ) with an interactive response system to escalating-dose subcutaneous IONIS-APO(a)Rx ( 100 mg , 200 mg , and then 300 mg , once a week for 4 weeks each ) or injections of saline placebo , once a week , for 12 weeks . Primary endpoints were mean percentage change in fasting plasma Lp(a ) concentration at day 85 or 99 in the per- protocol population ( participants who received more than six doses of study drug ) and safety and tolerability in the safety population . In a phase 1/2a first-in-man trial , we assessed the effect of IONIS-APO(a)-LRx , a lig and -conjugated antisense oligonucleotide design ed to be highly and selectively taken up by hepatocytes , at the BioPharma Services phase 1 unit ( Toronto , ON , Canada ) . Healthy volunteers ( Lp[a ] ≥75 nmol/L ) were r and omly assigned to receive a single dose of 10 - 120 mg IONIS-APO(a)LRx subcutaneously in an ascending-dose design or placebo ( in a 3:1 ratio ; single-ascending-dose phase ) , or multiple doses of 10 mg , 20 mg , or 40 mg IONIS-APO(a)LRx subcutaneously in an ascending-dose design or placebo ( in an 8:2 ratio ) at day 1 , 3 , 5 , 8 , 15 , and 22 ( multiple-ascending-dose phase ) . Primary endpoints were mean percentage change in fasting plasma Lp(a ) concentration , safety , and tolerability at day 30 in the single-ascending-dose phase and day 36 in the multiple-ascending-dose phase in participants who were r and omised and received at least one dose of study drug . In both trials , the r and omised allocation sequence was generated by Ionis Biometrics or external vendor with a permuted-block r and omisation method . Participants , investigators , sponsor personnel , and clinical research organisation staff who analysed the data were all masked to the treatment assignments . Both trials are registered with Clinical Trials.gov , numbers NCT02160899 and NCT02414594 . FINDINGS From June 25 , 2014 , to Nov 18 , 2015 , we enrolled 64 participants to the phase 2 trial ( 51 in cohort A and 13 in cohort B ) . 35 were r and omly assigned to IONIS-APO(a)Rx and 29 to placebo . At day 85/99 , participants assigned to IONIS-APO(a)Rx had mean Lp(a ) reductions of 66·8 % ( SD 20·6 ) in cohort A and 71·6 % ( 13·0 ) in cohort B ( both p From April 15 , 2015 , to Jan 11 , 2016 , we enrolled 58 healthy volunteers to the phase 1/2a trial of IONIS-APO(a)-LRx . Of 28 participants in the single-ascending-dose phase , three were r and omly assigned to 10 mg , three to 20 mg , three to 40 mg , six to 80 mg , six to 120 mg , and seven to placebo . Of 30 participants in the multiple-ascending-dose phase , eight were r and omly assigned to 10 mg , eight to 20 mg , eight to 40 mg , and six to placebo . Significant dose-dependent reductions in mean Lp(a ) concentrations were noted in all single-dose IONIS-APO(a)-LRx groups at day 30 . In the multidose groups , IONIS-APO(a)-LRx result ed in mean reductions in Lp(a ) of 66 % ( SD 21·8 ) in the 10 mg group , 80 % ( SD 13·7 % ) in the 20 mg group , and 92 % ( 6·5 ) in the 40 mg group ( p=0·0007 for all vs placebo ) at day 36 . Both antisense oligonucleotides were safe . There were two serious adverse events ( myocardial infa rct ions ) in the IONIS-APO(a)Rx phase 2 trial , one in the IONIS-APO(a)Rx and one in the placebo group , but neither were thought to be treatment related . 12 % of injections with IONIS-APO(a)Rx were associated with injection-site reactions . IONIS-APO(a)-LRx was associated with no injection-site reactions . INTERPRETATION IONIS-APO(a)-LRx is a novel , tolerable , potent therapy to reduce Lp(a ) concentrations . IONIS-APO(a)-LRx might mitigate Lp(a)-mediated cardiovascular risk and is being developed for patients with elevated Lp(a ) concentrations with existing cardiovascular disease or calcific aortic valve stenosis . FUNDING Ionis Pharmaceuticals",
"AIMS To evaluate the efficacy and safety of ezetimibe 10 mg administered with pravastatin in patients with primary hypercholesterolemia . METHODS AND RESULTS After dietary stabilization , 2 - 12 week screening/washout period , and 4-week , single-blind , placebo lead-in period , 538 patients with baseline LDL-C > or = 3.8 to were r and omized to one of eight possible treatments administered daily for 12 weeks : ezetimibe 10 mg ; pravastatin 10 , 20 , or 40 mg ; ezetimibe 10 mg plus pravastatin 10 , 20 , or 40 mg ; or placebo . The primary efficacy endpoint was percent reduction in LDL-C from baseline to study endpoint for ezetimibe 10 mg plus pravastatin ( pooled doses ) compared to pravastatin alone ( pooled doses ) and ezetimibe alone . The combined use of ezetimibe and pravastatin result ed in significant incremental reductions in LDL-C and TG compared to pooled pravastatin alone ( p LDL-C by 34 - 41 % , TG by 21 - 23 % , and increased HDL-C by 7.8 - 8.4 % , depending on the dose of pravastatin . The combined regimen was well tolerated , with a safety profile similar to pravastatin alone and placebo . CONCLUSIONS When coadministered with pravastatin , ezetimibe provided significant incremental reductions in LDL-C and TG and was well tolerated with a safety profile similar to pravastatin alone",
"BACKGROUND Oxidized phospholipids ( OxPL ) on apolipoprotein B-100 ( OxPL-apoB ) reflect the biological activity of lipoprotein(a ) ( Lp[a ] ) and predict cardiovascular disease events . However , studies with statins and low-fat diets show increases in OxPL-apoB and Lp(a ) . OBJECTIVE This study evaluated changes in OxPL-apoB and Lp(a ) with extended-release niacin ( N ) , ezetimibe/simvastatin ( E/S ) and combination E/S/N. A systematic literature review of previously published trials , measuring both OxPL-apoB and Lp(a ) after therapeutic interventions , was also performed . METHODS OxPL-apoB and Lp(a ) were measured in 591 patients at baseline and 24 weeks after therapy with N , E/S , or E/S/N in a previously completed r and omized trial of hypercholesterolemic patients . The literature review included 12 trials and 3896 patients evaluating statins , low-fat diets , antisense to apolipoprotein(a ) and lipid apheresis . RESULTS Niacin decreased OxPL-apoB levels ( median [ interquartile range ] ; 3.5 [ 2.2 - 9.2 ] nM to 3.1 [ 1.8 - 7.2 ] nM , P Lp(a ) ( 10.9 [ 4.6 - 38.4 ] to 9.3 [ 3.1 - 32.9 ] mg/dL , P OxPL-apoB ( 3.5 [ 2.1 - 7.8 ] to 4.9 [ 3.0 - 11.1 ] nM , P Lp(a ) ( 11.5 [ 6.1 - 36.4 ] to 14.9 [ 6.6 - 54.6 ] mg/dL , P statins and diet demonstrated 23.8 % and 21.3 % mean increases in OxPL-apoB and 10.6 % and 19.4 % increases in Lp(a ) , respectively . However 44.1 % and 52.0 % decreases in OxPL-apoB and Lp(a ) , respectively , were present with Lp(a)-lowering therapies . CONCLUSIONS This study demonstrates differential changes in OxPL-apoB and Lp(a ) with various lipid-lowering approaches . These changes in OxPL-apoB and Lp(a ) may provide insights into the results and interpretation of recent cardiovascular disease outcomes trials"
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urgical site infections ( SSIs ) continue to cause significant patient harm despite many advances in Sinfection prevention . The negative effects of SSIs on morbidity , mortality , and the cost of care has kept SSI reduction a top priority for health care organizations worldwide . A 2011 systematic review found that approximately 55 % of SSIs in the United States may be preventable by using evidence -based guidelines . Each SSI is associated with approximately 7 to 11 additional postoperative hospital days , and patients with an SSI have a 2 to 11 times higher risk of death compared with surgical patients without an SSI . In addition , 77 % of deaths in patients with SSIs are directly attributable to the SSI . From the patient ’s perspective , an infection delays healing , can increase time away from work or family , and can cause additional pain and complications ( eg , sepsis , long-term disabilities , death ) . Evidence -based strategies to reduce SSIs have been available for years and must be implemented in more health care facilities
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"BACKGROUND Nasal carriers of Staphylococcus aureus are at increased risk for health care-associated infections with this organism . Decolonization of nasal and extranasal sites on hospital admission may reduce this risk . METHODS In a r and omized , double-blind , placebo-controlled , multicenter trial , we assessed whether rapid identification of S. aureus nasal carriers by means of a real-time polymerase-chain-reaction ( PCR ) assay , followed by treatment with mupirocin nasal ointment and chlorhexidine soap , reduces the risk of hospital-associated S. aureus infection . RESULTS From October 2005 through June 2007 , a total of 6771 patients were screened on admission . A total of 1270 nasal swabs from 1251 patients were positive for S. aureus . We enrolled 917 of these patients in the intention-to-treat analysis , of whom 808 ( 88.1 % ) underwent a surgical procedure . All the S. aureus strains identified on PCR assay were susceptible to methicillin and mupirocin . The rate of S. aureus infection was 3.4 % ( 17 of 504 patients ) in the mupirocin-chlorhexidine group , as compared with 7.7 % ( 32 of 413 patients ) in the placebo group ( relative risk of infection , 0.42 ; 95 % confidence interval [ CI ] , 0.23 to 0.75 ) . The effect of mupirocin-chlorhexidine treatment was most pronounced for deep surgical-site infections ( relative risk , 0.21 ; 95 % CI , 0.07 to 0.62 ) . There was no significant difference in all-cause in-hospital mortality between the two groups . The time to the onset of nosocomial infection was shorter in the placebo group than in the mupirocin-chlorhexidine group ( P=0.005 ) . CONCLUSIONS The number of surgical-site S. aureus infections acquired in the hospital can be reduced by rapid screening and decolonizing of nasal carriers of S. aureus on admission . ( Current Controlled Trials number , IS RCT N56186788 .",
"HYPOTHESIS Deep infection after shoulder surgery is a rare but devastating problem . This study tested the hypothesis that the home application of a 2 % chlorhexidine gluconate cloth before shoulder surgery would be more efficacious than a st and ard shower of soap and water at decreasing the preoperative cutaneous levels of pathogenic bacteria on the shoulder . MATERIAL S AND METHODS This r and omized , prospect i ve study evaluated 100 consecutive patients undergoing shoulder surgery . Patients were r and omly assigned to use 2 % chlorhexidine gluconate-impregnated cloths ( treatment group ) or to shower with soap and water before surgery ( control group ) . Cutaneous cultures were taken from the patients ' shoulders in the preoperative holding area . Patients were monitored for 2 months postoperatively for clinical signs of infection . RESULTS In the treatment group vs the control group , the overall positive culture rate was 66 % vs 94 % ( P = .0008 ) , and the positive culture rate for coagulase-negative Staphylococcus was 30 % vs 70 % ( P = .0001 ) . The positive culture rate for Propionibacterium acnes was 46 % in the treatment group vs 58 % in the control group ( P = .32 ) . No infections occurred in any patients at a minimum of 2-months after surgery . DISCUSSION The use of the 2 % chlorhexidine cloth was effective at decreasing overall bacterial culture rates before shoulder surgery and was particularly effective at decreasing the quantity of coagulase-negative Staphylococcus , a known causative agent of postoperative shoulder infections . CONCLUSION Use of chlorhexidine impregnated cloths prior to shoulder surgery may be a useful adjunct to presently used infection prevention strategies",
"INTRODUCTION Mupirocin applied to the anterior nares four times daily usually eliminates Staphylococcus aureus , including methicillin resistant , within 48 hours . Prophylactic intranasal mupirocin is safe , inexpensive and effective in reducing the overall sternal wound infection after open-heart surgery . This study was design ed to determine whether decreasing nasal bacterial colonization by applying mupirocin intra nasally decreases mediastinal , sternal , pulmonary and cutaneous infections after open-heart surgery . MATERIAL & METHODS After institutional approval and informed consent , 392 patients were included in a r and omized , prospect i ve study . Nasal cultures were taken for all patients before surgery . Patients were divided in two groups : Group I ( n = 190 ) receiving mupirocin in the anterior nares 4 times daily for 48 hours before surgery ; Group II ( n = 202 ) was the control group . Patients were followed for a month after surgery . All mediastinal , sternal , pulmonary and cutaneous infections were documented and treated with appropriate antibiotics . A Student test for quantitative data and a chi2 test for qualitative data were used for statistical analysis . p two groups had the same demographic characteristics and risk factors . Nasal carriage of Staphylococcus was 36.2 % in the two groups . Neither mediastinitis nor sternitis were noticed in any of the two groups . There was no statistical difference between the groups according to the frequency of the cutaneous infections ( Group I : 19/190 - Group II : 13/202 ) and pneumonia ( Group I : 7/190 - Group II : 13/202 ) . In patients who had nasal carriage of Staphylococcus , nasal decontamination has not shown a statistical difference of cutaneous infections of the lower limbs nor pneumonia . Although nasal decontamination reduced the incidence of sternal wound infection ( Gr I 0/190 - Gr II 4/202 ; p = 0.017 ) . Staphylococcus aureus , in the control group , induced more cutaneous infections ( 30.8 % vs 11.7 % ; p = 0.048 ) . CONCLUSION The usage of mupirocin for nasal decontamination before open-heart surgery reduces the incidence of the sternal wound infection , and does not seem to affect the frequency of cutaneous infections of the lower limbs nor pneumonia after this surgery",
"Background An antimicrobial dressing containing ionic silver was found effective in reducing surgical-site infection in a preliminary study of colorectal cancer elective surgery . We decided to test this finding in a r and omized , double-blind trial . Methods Adults undergoing elective colorectal cancer surgery at two university-affiliated hospitals were r and omly assigned to have the surgical incision dressed with Aquacel ® Ag Hydrofiber dressing or a common dressing . To blind the patient and the nursing and medical staff to the nature of the dressing used , scrub nurses covered Aquacel ® Ag Hydrofiber with a common wound dressing in the experimental arm , whereas a double common dressing was applied to patients of control group . The primary end-point of the study was the occurrence of any surgical-site infection within 30 days of surgery . Results A total of 112 patients ( 58 in the experimental arm and 54 in the control group ) qualified for primary end-point analysis . The characteristics of the patient population and their surgical procedures were similar . The overall rate of surgical-site infection was lower in the experimental group ( 11.1 % center 1 , 17.5 % center 2 ; overall 15.5 % ) than in controls ( 14.3 % center 1 , 24.2 % center 2 , overall 20.4 % ) , but the observed difference was not statistically significant ( P = 0.451 ) , even with respect to surgical-site infection grade 1 ( superficial ) versus grade s 2 and 3 , or grade 1 and 2 versus grade 3 . Conclusions This r and omized trial did not confirm a statistically significant superiority of Aquacel ® Ag Hydrofiber dressing in reducing surgical-site infection after elective colorectal cancer surgery . Trial registration Clinical trials.gov :",
"PURPOSE In this study an examination was done of the effects of the American Society of PeriAnesthesia Nurses ( ASPAN ) Evidence -Based Clinical Practice Guidelines on body temperature , shivering , thermal discomfort , and time to achieve normothermia in patients undergoing total knee replacement arthroplasty ( TKRA ) under spinal anesthesia . METHODS This study was an experimental study with a r and omized controlled trial design . Participants ( n=60 ) were patients who underwent TKRA between December 2011 and March 2012 . Experimental group ( n=30 ) received active and passive warming measures as described in the ASPAN 's guidelines . Control group ( n=30 ) received traditional care . Body temperature , shivering , thermal discomfort , time to achieve normothermia were measured in both groups at 30 minute intervals . RESULTS Experimental group had slightly higher body temperature compared to control group ( p=.002 ) . Thermal discomfort was higher in the experimental group before surgery but higher in the control group after surgery ( p=.034 ) . It decreased after surgery ( p=.041 ) in both groups . Time to achieve normothermia was shorter in the experimental group ( p=.010 ) . CONCLUSION ASPAN 's guidelines provide guidance on measuring patient body temperature at regular intervals and on individualized and differentiated hypothermia management which can be very useful in nursing care , particularly in protecting patient safety and improving quality of nursing ",
"BACKGROUND Several pre- and intraoperative factors have been associated with incisional surgical site infection ( SSI ) , but little is known about the influence of postoperative wound care and especially , the use of different dressings on incisional SSI . The aim of this study was to compare 3 methods of wound dressings ( conventional dressing , silver-containing dressing , and mupirocin ointment dressing ) for their ability to prevent SSI , as measured by SSI rates , in patients with colorectal cancer undergoing elective open surgery . STUDY DESIGN A prospect i ve , r and omized study was performed . Inclusion criteria were diagnosis of colorectal neoplasms and plans to undergo elective surgery with curative aims . Patients were r and omized using a 1:1:1 allocation into 3 groups : patients receiving an ionic silver-containing dressing ( ISD ) ( group 1 ) , a mupirocin ointment application ( MOA ) ( group 2 ) , and a conventional dressing ( group 3 or st and ard dressing ) . The primary outcomes variable was occurrence of incisional SSI . Follow-up was 30 days postoperatively . RESULTS A total of 147 patients were included , 49 in each group . Incisional SSI occurred in 9 patients ( 18.4 % ) in the ISD group , 2 ( 4.1 % ) in the MOA group , and 10 ( 20.4 % ) in the st and ard dressing group ( p = 0.028 ) . Adjusting for multiple comparisons , there were no significant differences between ISD and st and ard dressing groups ; a significant difference was observed between ISD and MOA ( relative risk [ RR ] 4.5 ; 95 % CI ( 1.1 to 19.8 ) ; p = 0.046 ) and between the st and ard group and the MOA group ( RR 5 ; 95 % CI ( 1.2 to 21.7 ) ; p = 0.031 ) . CONCLUSIONS Topical application of mupirocin ointment achieves better results for the prevention of SSI than ionic silver-containing dressing or st and ard dressing in patients undergoing elective open colorectal surgery",
"BACKGROUND Treatment of Staphylococcus aureus colonization before surgery reduces risk of surgical site infection ( SSI ) . The regimen of nasal mupirocin ointment and topical chlorhexidine gluconate is effective , but cost and patient compliance may be a barrier . Nasal povidone-iodine solution may provide an alternative to mupirocin . METHODS We conducted an investigator-initiated , open-label , r and omized trial comparing SSI after arthroplasty or spine fusion in patients receiving topical chlorhexidine wipes in combination with either twice daily application of nasal mupirocin ointment during the 5 days before surgery or 2 applications of povidone-iodine solution into each nostril within 2 hours of surgical incision . The primary study end point was deep SSI within the 3 months after surgery . RESULTS In the modified intent-to-treat analysis , a deep SSI developed after 14 of 855 surgical procedures in the mupirocin group and 6 of 842 surgical procedures in the povidone-iodine group ( P = .1 ) ; S. aureus deep SSI developed after 5 surgical procedures in the mupirocin group and 1 surgical procedure in the povidone-iodine group ( P = .2 ) . In the per protocol analysis , S. aureus deep SSI developed in 5 of 763 surgical procedures in the mupirocin group and 0 of 776 surgical procedures in the povidone-iodine group ( P = .03 ) . CONCLUSIONS Nasal povidone-iodine may be considered as an alternative to mupirocin in a multifaceted approach to reduce SSI . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT01313182",
"PURPOSE We defined the relevant skin flora during genitourinary prosthetic surgery , evaluated the safety of chlorhexidine-alcohol for use on the male genitalia and compared chlorhexidine-alcohol to povidone-iodine in decreasing the rate of positive bacterial skin cultures at the surgical skin site before prosthetic device implantation . MATERIAL S AND METHODS In this single institution , prospect i ve , r and omized , controlled study we evaluated 100 consecutive patients undergoing initial genitourinary prosthetic implantation . Patients were r and omized to a st and ard skin preparation with povidone-iodine or chlorhexidine-alcohol . Skin cultures were obtained from the surgical site before and after skin preparation . RESULTS A total of 100 patients were r and omized , with 50 in each arm . Pre-preparation cultures were positive in 79 % of the patients . Post-preparation cultures were positive in 8 % in the chlorhexidine-alcohol group compared to 32 % in the povidone-iodine group ( p = 0.0091 ) . Coagulase-negative staphylococci were the most commonly isolated organisms in post-preparation cultures in the povidone-iodine group ( 13 of 16 patients ) as opposed to propionibacterium in the chlorhexidine-alcohol group ( 3 of 4 patients ) . Clinical complications requiring additional operations or device removal occurred in 6 patients ( 6 % ) with no significant difference between the 2 groups . No urethral or genital skin complications occurred in either group . CONCLUSIONS Chlorhexidine-alcohol was superior to povidone-iodine in eradicating skin flora at the surgical skin site before genitourinary prosthetic implantation . There does not appear to be any increased risk of urethral or genital skin irritation with the use of chlorhexidine compared to povidone-iodine . Chlorhexidine-alcohol appears to be the optimal agent for skin preparation before genitourinary prosthetic procedures",
"OBJECTIVE To compare the effects of different skin preparation solutions on surgical-site infection rates . DESIGN Three skin preparations were compared by means of a sequential implementation design . Each agent was adopted as the preferred modality for a 6-month period for all general surgery cases . Period 1 used a povidone-iodine scrub-paint combination ( Betadine ) with an isopropyl alcohol application between these steps , period 2 used 2 % chlorhexidine and 70 % isopropyl alcohol ( ChloraPrep ) , and period 3 used iodine povacrylex in isopropyl alcohol ( DuraPrep ) . Surgical-site infections were tracked for 30 days as part of ongoing data collection for the National Surgical Quality Improvement Project initiative . The primary outcome was the overall rate of surgical-site infection by 6-month period performed in an intent-to-treat manner . SETTING Single large academic medical center . PATIENTS All adult general surgery patients . RESULTS The study comprised 3,209 operations . The lowest infection rate was seen in period 3 , with iodine povacrylex in isopropyl alcohol as the preferred preparation method ( 3.9 % , compared with 6.4 % for period 1 and 7.1 % for period 2 ; P = .002 ) . In subgroup analysis , no difference in outcomes was seen between patients prepared with povidone-iodine scrub-paint and those prepared with iodine povacrylex in isopropyl alcohol , but patients in both these groups had significantly lower surgical-site infection rates , compared with rates for patients prepared with 2 % chlorhexidine and 70 % isopropyl alcohol ( 4.8 % vs 8.2 % ; P = .001 ) . CONCLUSIONS Skin preparation solution is an important factor in the prevention of surgical-site infections . Iodophor-based compounds may be superior to chlorhexidine for this purpose in general surgery patients",
"BACKGROUND Deep infection following shoulder surgery is a rare but devastating problem . The use of an effective skin-preparation solution may be an important step in preventing infection . The purpose s of the present study were to examine the native bacteria around the shoulder and to determine the efficacy of three different surgical skin-preparation solutions on the eradication of bacteria from the shoulder . METHODS A prospect i ve study was undertaken to evaluate 150 consecutive patients undergoing shoulder surgery at one institution . Each shoulder was prepared with one of three r and omly selected solutions : ChloraPrep ( 2 % chlorhexidine gluconate and 70 % isopropyl alcohol ) , DuraPrep ( 0.7 % iodophor and 74 % isopropyl alcohol ) , or povidone-iodine scrub and paint ( 0.75 % iodine scrub and 1.0 % iodine paint ) . Aerobic and anaerobic cultures were obtained prior to skin preparation for the first twenty patients , to determine the native bacteria around the shoulder , and following skin preparation for all patients . RESULTS Coagulase-negative Staphylococcus and Propionibacterium acnes were the most commonly isolated organisms prior to skin preparation . The overall rate of positive cultures was 31 % in the povidone-iodine group , 19 % in the DuraPrep group , and 7 % in the ChloraPrep group . The positive culture rate for the ChloraPrep group was lower than that for the povidone-iodine group ( p ChloraPrep and DuraPrep were more effective than povidone-iodine in eliminating coagulase-negative Staphylococcus from the shoulder region ( p eliminate Propionibacterium acnes from the shoulder region . No infections occurred in any of the patients treated in this study at a minimum of ten months of follow-up . CONCLUSIONS ChloraPrep is more effective than DuraPrep and povidone-iodine at eliminating overall bacteria from the shoulder region . Both ChloraPrep and DuraPrep are more effective than povidone-iodine at eliminating coagulase-negative Staphylococcus from the shoulder",
"OBJECTIVE The optimal treatment of hyperglycemia in general surgical patients with type 2 diabetes mellitus is not known . RESEARCH DESIGN AND METHODS This r and omized multicenter trial compared the safety and efficacy of a basal-bolus insulin regimen with glargine once daily and glulisine before meals ( n = 104 ) to sliding scale regular insulin ( SSI ) four times daily ( n = 107 ) in patients with type 2 diabetes mellitus undergoing general surgery . Outcomes included differences in daily blood glucose ( BG ) and a composite of postoperative complications including wound infection , pneumonia , bacteremia , and respiratory and acute renal failure . RESULTS The mean daily glucose concentration after the 1st day of basal-bolus insulin and SSI was 145 ± 32 mg/dL and 172 ± 47 mg/dL , respectively ( P 0.01 ) . Glucose readings with basal-bolus as compared with SSI in the composite outcome [ 24.3 and 8.6 % ; odds ratio 3.39 ( 95 % CI 1.50–7.65 ) ; P = 0.003 ] . Glucose 70 mg/dL was reported in 23.1 % of patients in the basal-bolus group and 4.7 % in the SSI group ( P of BG with glargine once daily plus glulisine before meals improved glycemic control and reduced hospital complications compared with SSI in general surgery patients . Our study indicates that a basal-bolus insulin regimen is preferred over SSI in the hospital management of general surgery patients with type 2 diabetes"
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41172990-06ff-11f0-808a-c43d1ab1c353
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Background : Stainless steel crowns ( SSCs ) are unique coronal restorative material s used commonly in the management of primary teeth with extensive caries . Aim : The aim of this study was to perform a systematic review to evaluate the retentive strength of luting cements for SSCs . Material s and Methods : Two review ers performed a data base search of the studies published from 2004 till date . The inclusion criteria were papers published in the English language and in vitro studies on retentive strength of SSC on primary molars . All potentially relevant studies were identified by the title and the abstract . After the full-text analysis , the selected studies were included in the systematic review . Results : Sixteen nonduplicated studies were found . However , after review ing the articles , only seven were included . Risk bias was assessed . Out of seven studies included in the systematic review , five studies presented medium risk of bias and two studies showed high risk of bias . Conclusion : Within the limitations of this study , thein vitro literature seems to suggest that the use of self-adhesive resin cements shows higher retentive strength , followed by resin-modified glass-ionomer cement ( RM-GIC ) and conventional GIC . However , RM-GIC can be a preferred luting agent due to its clinical advantages over resin cements . Thus , it can be concluded that choice of cement will depend on individual patient needs and clinical situation
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"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 %",
"Two alternative methods of restoring primary teeth that had multisurface lesions were examined in a clinical longitudinal study . In a paired comparison , stainless steel crowns proved far superior to multisurface amalgam restorations with respect to both lifespan and replacement rate . Stainless steel crowns are not only more acceptable to the patient and more cost effective , but also more acceptable to the dentist because of the comparatively simple procedures involved in restoring even severely affected primary molars",
"Aims To prospect ively report on the survival of resin-modified glass ionomer cement ( RMGIC ) , photac-fil and pre-formed stainless steel crown ( SSC ) restorations in primary molar teeth placed over a seven-year period in a specialist paediatric dental practice under private contract of remuneration . Method All primary molar restorations placed by a specialist paediatric dentist over a seven-year period were review ed and the outcome results recorded . Data were recorded at review visits until June 30 , 2003 . Data recorded included Class I restorations , Class II restorations and SSC . The Class II cavities were either mesial or distal , with or without buccal/palatal extensions . If both proximal surfaces were decayed or if after cavity preparation the result ant outline form was significantly larger than the minimal classical form , RMGIC was not used ; an SSC was placed instead . Stainless steel crown preparation followed conventional guidelines . The crowns were cemented with reinforced zinc oxide and eugenol ( Kalzinol ) . The status was recorded as satisfactory restoration , tooth exfoliated , tooth extracted for orthodontic reasons with the date of extraction , or needing replacement . If replaced then the reason for replacement was also recorded . Results A total of 544 Class I RMGICs , 962 Class II RMGICs , and 1,010 SSCs were placed . At the last review of each restoration , 98.3 % of Class I , 97.3 % of Class II RMGICs and 97.0 % of SSCs were either satisfactory or withdrawn intact . Conclusion Under the conditions of private specialist practice -based study SSCs continued to prove very successful for the restoration of larger cavities and for pulp-treated primary molar teeth . For the smaller cavities RMGIC were also very successful",
"The present study evaluated and compared the retentive strength of three luting cements . A total of forty five freshly extracted human primary molars were used in this study . The teeth were prepared to receive stainless steel crowns . They were then r and omly divided into three groups , of fifteen teeth each , so as to receive the three different luting cements : conventional glass ionomer resin modified glass ionomer and adhesive resin . The teeth were then stored in artificial saliva for twenty four hours . The retentive strength of the crowns was determined by using a specially design ed Instron Universal Testing Machine ( Model 1011 ) . The data was statistically analyzed using ANOVA to evaluate retentive strength for each cement and Tukey test for pair wise comparison . It was concluded that retentive strength of adhesive resin cement and resin modified glass ionomer cement was significantly higher than that of the conventional glass ionomer cement",
"OBJECTIVES This study compares the probabilities of survival and modes of failure of cast full-coverage crowns bonded with five cements when subjected to tensile pull-off testing . METHODS Five groups of 25 sound human premolar teeth were prepared for full-coverage crowns , impressions recorded and customized castings fabricated in Ni-Cr-Mb bonding alloy . The cements tested were zinc phosphate , a h and -mixed and capsulated conventional glass-ionomer cement , a resin-modified glass-ionomer cement and a resin composite luting cement . The cemented crowns were stored in water at 37 degrees C for 24 h prior to application of a tensile pull-off force at a strain rate of 10 mm/min . The loads at failure were ranked and modelled by derived Weibull functions each describing the probability of a given specimen failing under a given load . Non-parametric statistical analysis was also applied to the results . RESULTS There were no significant differences between the loads at failure of zinc phosphate cement , the h and -mixed or the capsulated glass-ionomer cements . The resin-modified glass-ionomer cement and the resin composite cement failed at significantly higher loads than the other three cements , but were not significantly different from each other . The Weibull modulus ranking for each cement from highest to lowest was resin composite = zinc phosphate , resin-modified glass-ionomer , h and -mixed conventional glass-ionomer and capsulated conventional glass-ionomer cement . SIGNIFICANCE Weibull analysis allows dentists to compare the probability of survival of a crown bonded with different cements at a chosen load giving an indication of cement reliability",
"This study was conducted on 30 extracted human primary molars to assess the retentive strengths of zinc phosphate , polycarboxylate and glass ionomer cements . The teeth were embedded in resin blocks and were r and omly divided into 3 groups of 10 each . The occlusal surfaces of all teeth were reduced uniformly by 1.0 to 1.5 mm . All mesial , distal undercuts were removed and sharp angles rounded . This was followed by cementing pretrimmed and precontoured stainless steel crowns on each tooth with h and pressure and storing in artificial saliva at 37 degrees C for 24 hours . Retentive strength was tested using Instron Universal Testing Machine . The load was applied starting from a zero reading and gradually increased until the cemented stainless steel crowns showed signs of movement and then the readings were recorded . It was found that retentive strengths of zinc phosphate and glass ionomer cements were statistically better ( P polycarboxylate cement . Negligible difference ( 0 . 59 kg/cm2 ) was however observed between zinc phosphate and glass ionomer cements",
"The two cements were of comparable performance",
"PURPOSE The first purpose of this study was to compare the retentive values of zinc phosphate and Panavia F resin cements when used for luting cast dowel and cores . The second purpose was to determine whether the use of a lubricant when making the resin pattern for a custom dowel and core would have an effect on the final retention of dowels cemented with either zinc phosphate or Panavia F cements . METHODS AND MATERIAL S Sixty-three caries-free extracted single-rooted human teeth were r and omly divided into three groups of 21 . Root canal preparations were st and ardized for all 63 teeth . Clinical protocol s for fabricating and cementing dowel and core restorations were examined , comparing zinc phosphate and Panavia F resin cements . Direct dowel patterns were fabricated using the Para Post system and cast in a noble metal alloy . Group I dowel spaces were lubricated with GC lubricant prior to dowel pattern fabrication and cleaned with Cavidry solvent before cementing the cast dowel and core with zinc phosphate cement . Group II dowel spaces were rinsed with water only prior to dowel pattern fabrication . The dowels and cores in this group were cemented with Panavia F resin cement . Group III dowel spaces were lubricated with GC lubricant prior to dowel pattern fabrication ; the dowel spaces were cleaned with Cavidry solvent before the cast dowel and cores were cemented with Panavia F cement . The tensile force necessary to remove the cast dowel and cores was determined using a universal testing machine . Results were statistically analyzed using one-way ANOVA and Tukey 's HSD test . RESULTS The dowels and cores in Group I had significantly higher retentive values than either of the two Panavia F groups ( p retentive values ( p > 0.05 ) was found between dowels luted with either of the lubricating agents in the Panavia F groups . CONCLUSIONS Zinc phosphate cement had higher retentive values when cementing cast dowel and cores than Panavia F. The type of lubricant used for the resin dowel fabrication ( water or GC lubricant that was removed with a solvent ) had no effect on the retention of cast dowels cemented with Panavia"
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411729cc-06ff-11f0-808a-c43d1ab1c353
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Different adipokines secreted from adipose tissue , exert a range of physiological effects . The aim of present systematic review and meta- analysis was to critically investigate the consequence of bariatric surgery on circulating adipokines , that is , adiponectin , leptin , visfatin , resistin , plasminogen activator inhibitor , and chemerin . After systematic ally checking the following electronic data bases : ISI web of Science , Scopus and PubMed without limitation in time and language up to February 2019 , a pool based on a r and om effect model was established . Eighty-five eligible studies were entered for quantitative analysis . Our meta- analysis revealed that circulating adiponectin increased significantly after bariatric surgery [ St and ardized mean difference (SMD)=1.401 , 95 % CI : 1.101 , 1.701 , p leptin ( SMD=-2.178 , 95 % CI : -2.433 , -1.923 , p chemerin ( -50.238 ng/ml 95 % CI : -85.708 , -14.768 , p serum visfatin ( 2.05 ng/ml , 95 % CI : -5.07 , 9.17 , p=0.573 ) and resistin ( -2.080 ng/ml , 95 % CI : -5.352 , 1.192 , p=0.21 ) were unchanged . In conclusion , bariatric surgery is associated with a reduction in specific adipokines including leptin , chemerin , and PAI-1 , whereas adiponectin is raised , adaptations that could be indicative of improved fat mass and function
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"Objective : Adipokines are signaling and mediator proteins secreted from adipose tissue . A novel adipokine , visfatin , was reported as a protein which was mainly expressed in visceral adipose tissue . Controversial results have been shown regarding the changes of adipokines following weight reduction . So we investigated the effects of weight reduction on serum concentrations of adiponectin and visfatin in morbidly obese subjects . Methods : 35 severely obese patients ( 26 females and 9 males ) , aged 15 - 58 years , were studied . Anthropometric parameters and biochemical parameters as well as adiponectin and visfatin were analyzed before and 6 weeks after weight reduction . Results : Anthropometric indices decreased significantly . Blood levels of low-density lipoprotein cholesterol , high-density lipoprotein cholesterol , and triglyceride were reduced significantly . The reduction of visfatin and the elevation of adiponectin were significant as well . However , other parameters like fasting glucose and insulin did not change . Moreover , we could not find any significant correlation between the change of serum visfatin and that of adiponectin . Conclusions : 6-week weight reduction after bariatric surgery result ed in decreased serum visfatin and increased adiponectin levels . However , we can not find any significant correlation between changes of adiponectin , visfatin , BMI , waist circumference , and insulin resistance . Further studies with different design are suggested to clarify these associations",
"ABSTRACT Background : The aim of this study was to examine the relationship between weight loss and resistin , apelin , chemerin , and visfatin after laparoscopic adjustable gastric b and ing ( LAGB ) . Methods : The study group consisted of 19 patients who were operated on for morbid obesity ( BMI : 48.7 ± 6.6 kg/m2 ) , and 22 healthy , normal-weight ( BMI : 22.9 ± 2.5 kg/m2 ) subjects formed the control group . We obtained blood sample s from the study subjects at three different times : before undergoing surgery and at one month and 6 months after surgery . Blood was obtained once from the control group . Results : Significant weight loss was achieved at one and 6 months after surgery . Plasma levels of apelin , resistin , chemerin , and visfatin were higher in morbidly obese patients compared with the control group . Obesity-related peptides decreased one month and 6 months after surgery . Conclusions : Elevated plasma resistin , apelin , chemerin , and visfatin levels in morbidly obese patients are gradually reduced after weight loss . According to these findings , LAGB surgery is found to be an important and efficient means for morbidly obese patients both to lose weight and to develop a better metabolic risk profile in a short time period",
"Background Obesity is associated with a chronic low- grade inflammatory state , insulin resistance , and endothelial dysfunction , all of which contribute to increased risk of cardiovascular disease . We hypothesized that gastric bypass would produce rapid improvements in endothelial function , reduce inflammation , and lead to a decrease in cardiovascular risk . Methods We performed a prospect i ve study of morbidly obese patients who underwent laparoscopic Roux-en-Y gastric bypass ( RYGB ) . Clinical data , biochemical markers of inflammation , and parameters indicative of cardiovascular risk were collected preoperatively and at 3 and 6 months postoperatively . Metabolic and inflammatory mediators that were quantified included C-reactive protein , fibrinogen , PAI-1 , IL-6 , IL-10 , IL-1Ra , adiponectin , leptin , triglycerides , total cholesterol , HDL , LDL , glucose , insulin , and HbA1c . Brachial artery reactivity testing ( BART ) was performed to assess peripheral arterial endothelial function , and Framingham cardiovascular risk score ( FRS ) was calculated on all study participants pre- and postoperatively . Results Fifteen patients ( 11 female ) were enrolled ( age = 49.2 ± 10.4 years ; BMI = 48.1 ± 5.3 kg/m2 ) . Six months post RYGB , mean BMI decreased to 35.4 ± 4.5 , corresponding to 51.7 % excess weight loss ( P 0.001 ) . Mean waist circumference decreased significantly from 132 cm at baseline to 110 cm at 3 months ( P = 0.003 ) and 107 cm at 6 months ( P weight loss led to significant improvements in clinical parameters indicative of cardiovascular disease or risk , including brachial artery diameter , endothelial independent vasodilation , and FRS . Favorable improvements in the proinflammatory markers CRP ( P = 0.01 ) and leptin ( P = 0.005 ) , the anti-inflammatory mediator adiponectin ( P = 0.002 ) , and insulin sensitivity ( HOMA-IR , P = 0.007 ) were evident at 3 months . At 6 months , improvements in CRP , leptin , and fasting insulin were maintained and fibrinogen levels also decreased ( P = 0.047 ) . Adiponectin continued to increase at 6 months ( P = 0.004 ) . Conclusion Gastric bypass is associated with early reversal of endothelial dysfunction , a more favorable inflammatory milieu , and , most importantly , a reduction in cardiovascular risk",
"Weight reduction after gastric bypass surgery has been attributed to a decrease of the orexigenic peptide ghrelin , which may be regulated by insulin and leptin . This study examined effects of long-term weight loss after laparoscopical adjustable gastric b and ing on plasma ghrelin and leptin concentrations and their relationship with insulin action . Severely obese patients ( 15 women , three men , 36 + /- 12 yr ) underwent clinical examinations every 3 months and modified oral glucose tolerance tests to assess parameters of insulin sensitivity and secretion every 6 months . After surgery , body mass index fell from 45.3 + /- 5.3 to 37.2 + /- 5.3 and 33.6 + /- 5.5 kg/m(2 ) at 6 and 12 months , respectively ( P plasma glucose , insulin , insulin resistance , waist circumference , and blood pressure . Plasma leptin decreased from 27.6 + /- 9.5 to 17.7 + /- 9.8 ( P = 0.0005 ) and 12.7 + /- 5.1 ng/ml ( P Plasma ghrelin was comparable before and at 6 months ( 234 + /- 53 ; 232 + /- 53 pmol/liter ) but increased at 12 months ( 261 + /- 72 pmol/liter ; P = 0.05 vs. 6 months ) . At 6 and 12 months , ghrelin levels correlated negatively with fasting plasma insulin levels and hepatic insulin extraction but not with body mass or insulin action . In conclusion , prolonged weight loss results in a rise of fasting ghrelin concentrations that correlates with fasting insulin concentrations but not improvement of insulin sensitivity",
"The purpose of present study was to investigate plasma adiponectin response to acute exercise in highly trained male rowers . Ten rowers performed a maximal 6,000-m rowing ergometer test [ mean performance time ≈20 min ; 1,200.8 ( 29.9 ) s ] , and venous blood sample s were obtained before , immediately after and after 30 min of recovery . In addition to adiponectin concentration , leptin , insulin , growth hormone and glucose values were measured . Adiponectin was not changed immediately after the exercise when uncorrected for plasma volume changes ( −8.1 % ; P>0.05 ) . However , adiponectin was decreased immediately after the exercise when adjusted for plasma volume changes ( −11.3 % ; P ) . Adiponectin was significantly increased above the resting value after the first 30 min of recovery ( uncorrected for plasma volume , + 19.3 % ; corrected for plasma volume , + 20.0 % ) . No changes occurred in plasma leptin and insulin concentrations with exercise ( uncorrected for plasma volume changes ) . While growth hormone and glucose values were significantly increased and decreased to the pre-exercise level immediately after the exercise and after the first 30 min of recovery , respectively ( uncorrected for plasma volume changes ) , no differences in the responses to exercise were observed in these measured blood parameters when adjusting for plasma volume changes . There were no relationships between plasma adiponectin and other measured blood parameters before and after the exercise , nor were changes in adiponectin related to changes in other measured blood biochemical values after the exercise . These results suggest that plasma adiponectin is altered as a result of maximal acute exercise in highly trained athletes",
"Purpose Bariatric surgery ( BS ) promotes carotid intima-media thickness ( C-IMT ) regression as early as 6 months post-surgery . To verify whether C-IMT regression occurs even earlier , we aim ed at the effect of Roux-en-Y gastric bypass ( RYGBP ) and biliopancreatic diversion ( BPD ) on C-IMT 1–2 months and 12 months post-surgery . Subjects/ Methods Prospect i ve trial . BS was performed on 109 patients either with ( RYGBP = 42 ; BDP = 40 ) or without type 2 diabetes ( RYGBP = 27 ) . Healthy volunteers served as control group . Follow-up : baseline , 1–2 months , 12 months post-surgery . Endpoints : changes ( ∆ ) in C-IMT , weight , body mass index , fat mass , waist and neck circumferences , blood pressure , HbA1c , glucose , insulin , insulin sensitivity [ HOMA-IR ; OGIS , from meal tolerance test ] , lipids , C-reactive protein , leptin , adiponectin , MCP-1 . Results All surgery subgroups had similar levels of ∆-C-IMT . C-IMT in the pooled surgery group reduced from [ mean ( 95 % confidence interval ) ] 0.81 ( 0.77–0.84 ) mm to 0.66 ( 0.63–0.69 ) mm , p . ∆-C-IMT 1–2 months and 12 months post-surgery correlated to baseline C-IMT , and with ∆-leptin at 1–2 months , but not at 12 months post-surgery . In linear regression analysis , ∆-leptin and baseline C-IMT were predictors of ∆-C-IMT 1–2 months post-surgery . Conclusions A remarkable C-IMT regression occurred as early as 1–2 months after BS in obese patients either with or without type 2 diabetes , which was associated to the early reduction in leptin , ( at least partially ) independent of weight loss . Whether this is a causative or correlative association needs further investigation",
"Introduction Hypoglycemia is a known adverse event following gastric bypass . The incidence of hypoglycemia after laparoscopic sleeve gastrectomy ( LSG ) is still under investigation . The aim of our study was to verify the presence of oral glucose tolerance test (OGTT)-related hypoglycemia after LSG and to identify any baseline predictors of its occurrence . Methods We analyzed 197 consecutive non-diabetic morbid obese patients that underwent LSG . All patients were studied before and 12 months after LSG . Evaluation included anthropometric parameters , 3-h OGTT for blood glucose ( BG ) , insulin and c-peptide , lipid profile , interleukin-6 ( IL-6 ) , tumor necrosis factor alpha ( TNF-α ) , highly sensitive C-reactive protein ( hsCRP ) , and leptin . Hypoglycemia was defined as BG ≤ 2.7 mmol/l . Results After surgery , 180 patients completed the OGTT . Eleven patients did not complete the test for gastric intolerance , and in six patients , the test was stopped earlier for the onset of severe symptomatic hypoglycemia . Of the patients , 61/186 ( 32.8 % ) had at least one OGTT-related hypoglycemia . The highest frequency of hypoglycemic events occurred 150′ after glucose load ( 20.2 % ) . At baseline , patients with hypoglycemic events after surgery ( Hypo ) were younger ( 40 ± 11 vs 46 ± 10 years ; p ± 5.7 vs 48.4 ± 7.9 kg/m2 ; p worse lipid profile as compared to patients without hypoglycemic events ( N-Hypo ) . Moreover , after LSG , Hypo patients compared with N-Hypo presented a higher weight loss ( % E BMI L 80 ± 20 vs 62 ± 21 % ; p age , low fasting glucose , and high triglyceride levels before LSG were independent predictors of hypoglycemia development after surgery ( r2 = 0.131 ) . Conclusion These findings confirm the high incidence of post-pr and ial hypoglycemia 1 year after LSG . Hypoglycemia is more frequent in younger patients with lower fasting glucose and higher triglyceride levels before surgery",
"Abstract Background We have previously shown that a Palaeolithic diet consisting of the typical food groups that our ancestors ate during the Palaeolithic era , improves cardiovascular disease risk factors and glucose control compared to the currently recommended diabetes diet in patients with type 2 diabetes . To eluci date the mechanisms behind these effects , we evaluated fasting plasma concentrations of glucagon , insulin , incretins , ghrelin , C-peptide and adipokines from the same study . Methods In a r and omised , open-label , cross-over study , 13 patients with type 2 diabetes were r and omly assigned to eat a Palaeolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts , or a diabetes diet design ed in accordance with current diabetes dietary guidelines during two consecutive 3-month periods . The patients were recruited from primary health-care units and included three women and 10 men [ age ( mean ± SD ) 64 ± 6 years ; BMI 30 ± 7 kg/m2 ; diabetes duration 8 ± 5 years ; glycated haemoglobin 6.6 ± 0.6 % ( 57.3 ± 6 mmol/mol ) ] with unaltered diabetes treatment and stable body weight for 3 months prior to the start of the study . Outcome variables included fasting plasma concentrations of leptin , adiponectin , adipsin , visfatin , resistin , glucagon , insulin , C-peptide , glucose-dependent insulinotropic polypeptide , glucagon-like peptide-1 and ghrelin . Dietary intake was evaluated by use of 4-day weighed food records . Results Seven participants started with the Palaeolithic diet and six with the diabetes diet . The Palaeolithic diet result ed in a large effect size ( Cohen ’s d = −1.26 ) at lowering fasting plasma leptin levels compared to the diabetes diet [ mean difference ( 95 % CI ) , −2.3 ( −5.1 to 0.4 ) ng/ml , p = 0.023 ] . No statistically significant differences between the diets for the other variables , analysed in this study , were observed . Conclusions Over a 3-month study period , a Palaeolithic diet result ed in reduced fasting plasma leptin levels , but did not change fasting levels of insulin , C-peptide , glucagon , incretins , ghrelin and adipokines compared to the currently recommended diabetes diet . Trial registration : Clinical Trials.gov",
"The relationship between insulin action and control of the adipocyte-derived factor adiponectin was studied in age- and weight-matched obese individuals with type 2 diabetes failing sulfonylurea therapy . After initial metabolic characterization , subjects were r and omized to troglitazone or metformin treatment groups ; all subjects received glyburide ( 10 mg BID ) as well . Treatment was continued for 3 months . The extent of glycemic control after treatment was similar in both groups . However , the increase in maximal insulin-stimulated glucose disposal rate was greater following troglitazone therapy ( + 44 % ) compared with metformin treatment ( + 20 % ) . Troglitazone treatment increased serum adiponectin levels nearly threefold . There was no change in serum adiponectin with metformin treatment . A positive correlation was found between increases in whole-body glucose disposal rates and serum adiponectin levels after troglitazone ; no such relationship was seen with metformin . The adiponectin protein content of subcutaneous abdominal adipocytes was increased following troglitazone treatment and unchanged after metformin . Adiponectin release from adipocytes was also augmented with troglitazone treatment . Adiponectin was present in adipocytes and plasma in several multimeric forms ; a trimer was the major form secreted from adipocytes . These results indicate that increases in adiponectin content and secretion are associated with improved insulin action but are not directly related to glycemic control . Modulation of adipocyte function , including upregulation of adiponectin synthesis and secretion , may be an important mechanism by which thiazolidinediones influence insulin action",
"Background The relative contribution of anthropometric , hormonal , and metabolic changes after bariatric surgery ( BS ) on sexual function ( SF ) in severely obese subjects is not well established . Methods Prospect i ve observational case series study of 39 men undergoing BS . SF was assessed by means of the international index of erectile function ( IIEF ) before and at 1 year after surgery . At the same time points , anthropometric ( body mass index , waist circumference ) , hormonal ( testosterone , sex hormone binding globulin , estradiol , gonadotropins , inhibin B , prolactin , leptin ) , and metabolic parameters ( insulin sensitivity , C-reactive protein , lipid profile , hemoglobin A1c , presence of hypertension or sleep apnea ) were assessed . Results BS was associated with marked weight loss ( 77.18 % excess weight loss ) , improved IIEF score ( baseline : 54.85 ± 16.59 , 1 year : 61.21 ± 14.10 ; p gonadal function ( testosterone : baseline 256.36 ± 120.98 , 1 year : 508.01 ± 161.90 ; p improved metabolic profile . However , on multivariate regression analysis whereas changes in body mass index ( beta : −0.677 , p = 0.001 ) , and baseline IIEF score ( beta : −0.397 , p = 0.023 ) , were independent predictors of the changes in the IIEF score at 1 year after surgery , changes in hormonal and metabolic factors were not . Variables in the model accounted for 66 % of the postsurgical variation in the IIEF score . Similar results were found when the different IIEF-sexual domains were evaluated , except for intercourse satisfaction for which no independent predictor was identified . Conclusions Weight loss ’s beneficial effects on SF occurring after BS are beyond the parallel improvement in gonadal and metabolic profiles",
"OBJECTIVE Adiponectin is the most abundant protein secreted by adipose tissue and is inversely associated with adiposity and insulin resistance . The aim of this study was to evaluate the hypothesis that marked weight loss , induced by gastric bypass surgery ( GBS ) , would increase adiponectin gene expression in both upper and lower subcutaneous body fat and increase plasma adiponectin concentration . RESEARCH METHODS AND PROCEDURES Adiponectin subcutaneous abdominal and femoral adipose tissue gene expression , determined by using quantitative reverse transcriptase-polymerase chain reaction , and adiponectin plasma concentrations , determined by using enzyme-linked immunosorbent assay , were evaluated in six extremely obese women ( BMI = 57.1 + /- 4.1 kg/m2 ) before and 1 year after GBS . RESULTS After GBS , subjects lost 36 + /- 5 % of their initial body weight and showed increased insulin sensitivity , manifested by a marked decrease in homeostasis model assessment of insulin resistance from 10.7 + /- 4.1 to 1.4 + /- 0.3 ( p Adiponectin gene expression increased 8- to 15-fold in subcutaneous abdominal and femoral adipose tissues ( p Plasma adiponectin concentrations increased from 5.2 + /- 0.9 to 8.4 + /- 1.2 mug/mL ( p < 0.05 ) . DISCUSSION These data show that marked weight loss induced by GBS increases adiponectin gene expression in both upper- and lower-body subcutaneous fat . The increase in adipose tissue adiponectin production result ed in an increase in plasma adiponectin concentrations , which likely contributed to the decrease in insulin resistance observed after weight loss",
"The impact of energy economy on body weight loss was investigated in 20 obese women , su bmi tted to Roux-en-Y gastric bypass . Resting energy expenditure ( REE ) , substrate oxidation rates , plasma glucose , free fatty acid , and insulin and leptin levels were measured before and 3 , 6 , and 12 months after surgery . Predicted REE was obtained from linear regression analysis of REE and fat free mass , in a group of 85 women , whose body mass index ranged between 20 and 60 kg/m(2 ) . The deviation from predicted REE , calculated as area under the curve ( AUC ) over the 12-month period for each patient , was considered as the expression of energy economy . Energy economy AUC was significantly ( P : weight lost during 12 months after surgery . Energy intake , calculated from self-reported food consumption , was also expressed as AUC . Energy intake AUC showed a significant ( P : weight loss . Lipid oxidation rate , also calculated as AUC , significantly correlated , negatively , with energy economy ( P : energy intake ( P : Preoperative leptin values were significantly ( P : Roux-en-Y gastric bypass , energy economy hampers the weight loss process , probably through a low fat oxidation rate",
"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 Increased visceral adipose tissue ( VAT ) is thought to be a risk factor for cardiovascular and metabolic diseases . There are only limited data on whether VAT loss after laparoscopic gastric b and ing surgery ( LGBS ) is related to risk factor reduction . This study determined whether improvements in risk markers , in particular insulin resistance , were related to VAT reduction at 6 months after LGBS ( T2 ) . Methods Thirty-four LGBS patients and 17 normal weight controls underwent initial and T2 testing . Fasting venous blood sample s were taken to evaluate glucose , insulin , hemoglobin A1c , lipids , C-reactive protein ( CRP ) , and hormone profiles . Insulin resistance was estimated using the homeostasis model assessment ( HOMA ) index . VAT was measured using CT techniques . Data were analyzed using repeated measures ANOVA and regression analysis . Results Results at T2 showed that patients had significant improvements in body composition , HOMA , and hemoglobin A1c . There were also reductions in plasma renin activity and leptin , and increases in ghrelin and GLP-1 . Reductions in VAT were significantly correlated with reductions in insulin , HOMA , and glucose . While high density lipoprotein cholesterol , triglycerides , CRP , and the apolipoprotein A1/B ratio were also improved , VAT reduction was significantly correlated only with an increased apolipoprotein A1/B ratio . Conclusion These data indicate that 6 months after LGBS there were significant improvements in many cardiovascular and metabolic risk markers . However , VAT reduction was most strongly associated with reductions in insulin resistance . Body weight loss was not associated with markers of improved insulin sensitivity",
"OBJECTIVE Soluble leptin receptor ( sOB-R ) represents the main binding site for leptin in human blood . The aim of this study was to investigate the relationship between leptin and soluble leptin receptor and the bound/free ratio after pronounced weight reduction . RESEARCH METHODS AND PROCEDURES A total of 18 morbidly obese women participated in this prospect i ve study . Subjects were examined for fat mass , leptin , and sOB-R concentrations before and 1 year after Swedish adjustable gastric b and ing . RESULTS Anthropomorphic measures displayed a significant reduction of body mass index [ ( 42.9 + /- 5.6 to 32.9 + /- 6.0 kg/m(2 ) ( mean + /- SD ) ] . Fat mass decreased from 56.3 + /- 9.0 to 33.9 + /- 12.5 kg . Plasma leptin concentration decreased from 44.6 + /- 18.0 to 20.0 + /- 13.1 ng/mL ( p sOB-R levels increased from 11.1 + /- 3.6 to 16.6 + /- 6.0 U/mL after weight-reducing surgery . Thus , the sOB-R bound fraction of leptin increased from 7 % to 33 % . DISCUSSION This work demonstrates a relationship between weight loss , leptin , and sOB-R concentrations in vivo . During weight loss , leptin levels decreased , whereas sOB-R levels and the receptor bound fraction of leptin increased . Thus , sOB-R may negatively regulate free leptin",
"BACKGROUND We investigated the biochemical and inflammatory parameters as well as biomarkers of oxidative stress in morbidly obese patients before and after bariatric surgery and clinical treatment . METHODS This study was conducted using 60 individuals ( 10 men and 50 women ) distributed into 3 groups : the control group , 20 non-diabetic obese patients given clinical treatment , the bariatric group , 20 non-diabetic obese patients given a Roux-en-Y bypass gastroplasty , and the bariatric diabetic group , 20 diabetic obese patients given a Roux-en-Y bypass gastroplasty . Measurements were made before and 1 , 3 , 6 , and 12months after surgery and clinical treatment . RESULTS We showed a significant decrease in body weight , body mass index ( BMI ) and waist circumference , accompanied by a decrease in the lipid profile and glucose and glycated hemoglobin concentrations in the groups that received bariatric surgery . The concentrations of lipid peroxidation , carbonyl protein and NPSH , as well as superoxide dismutase ( SOD ) and catalase ( CAT ) activity , significantly decreased in both groups after surgery . The concentrations of inteleukin-6 , inteleukin-1 , TNF-α and resistin were also significantly lower , while adiponectin concentrations significantly increased 12months after bariatric surgery . No significant alterations were observed in the biochemical , inflammatory or oxidative parameters of the control group . CONCLUSIONS Our findings demonstrate a decrease in body mass and a subsequent improvement in biochemical , metabolic and anthropometric parameters in patients given bariatric surgery . This may contribute to the reduction of oxidative damage in these patients and consequently a reduction in the risk of the development and progression of multiple co-morbidities associated with obesity",
"OBJECTIVE To analyze the relationship between visceral fat accumulation and resting energy expenditure in obese women and to evaluate the effects of a severe weight loss both on energy expenditure and on fat distribution . DESIGN Twelve premenopausal women , aged 19 - 50 years , undergoing adjustable silicone gastric b and ing ( ASGB ) for morbid obesity participated at the study . The patients were evaluated twice . The baseline evaluation was performed immediately before surgery . After surgery , a diet specifically developed for patients su bmi tted to gastric restriction ( 2.5 MJ/day ) was given to the patients . The second evaluation was performed 6 months after surgery . MEASUREMENTS Resting metabolic rate ( RMR ) was determined by indirect calorimetry . Total fat area ( TFA ) , visceral fat area ( VFA ) and subcutaneous fat area ( SFA ) were measured by abdominal computed tomography . Fat mass ( FM ) and fat free mass ( FFM ) were derived by bioelectrical impedance analysis . RESULTS At baseline , RMR was positively related to VFA ( r = 0.60 , P weight loss of 24.4 + /- 9.0 kg . This weight reduction was mainly due to a loss of FM ( 68.5 + /- 10.8 vs 48.5 + /- 9.2 kg , P FFM was only slightly reduced ( 52.6 + /- 4.0 vs 47.9 + /- 4.6 kg , P BMI reduction was positively related to the baseline BMI and FM values ( r = 0.61 , P BMI reduction and the baseline variables of fat distribution , nor between the BMI reduction and the basal RMR . Weight loss was accompanied by modifications of fat distribution . In particular , the reduction of VFA after surgery was strictly related to the VFA values at baseline ( r = 0.91 , P Weight loss induced a significant reduction of RMR ( 7.96 + /- 1.77 vs 6.57 + /- 6.90 MJ/day ; P the RMR observed with weight loss was significantly related to the FFM loss ( r = 0.63 , P RMR was analyzed by multiple regression analysis . In this model , both FFM and visceral fat changes result ed independently related to the RMR . CONCLUSIONS ( 1 ) visceral fat accumulation was a significant predictor of RMR in the very obese woman ; ( 2 ) visceral obese women lost more visceral fat than subcutaneous ones ; ( 3 ) the reduction of the RMR observed during weight loss could partly be explained by a reduction of visceral fat mass",
"Cardiovascular disease remains the leading cause of death in women . Both obesity and diabetes mellitus are important independent risk factors for the development of cardiovascular disease . Obesity is the leading risk factor for type 2 diabetes . The Centers for Disease Control and Prevention report that 32 % of white and 53 % of black women are obese . Women with a body mass index ( BMI ) of 30 kg/m2 have a 28 times greater risk of developing diabetes than do women of normal weight . The risk of diabetes is 93 times greater if the BMI is 35 kg/m2.1 The presence of diabetes can increase a woman 's risk of heart disease 2-fold . In addition , the presence of diabetes overshadows the protective effects of the premenopausal state . In 2007 , 11.5 million of all women over the age of 20 ( 10.2 % ) had diabetes , and rates were slightly higher in ethnic minority groups : 10.4 % in Hispanic women and 11.8 % in non-Hispanic black women.2 The national prevalence rates of diabetes have increased in parallel with the rates of obesity ( Fig. 1 ) . Fig. 1 Age-adjusted percentage of U.S. adults who were obese or who had a diagnosis of diabetes mellitus . Screening Screening for obesity and diabetes is the 1st step to treatment and often reveals individuals who are at risk for but do not yet have overt disease . The United States Preventive Services Task Force ( USPSTF ) recommends that all adults be screened for obesity . Obesity signifies excess adipose tissue . The most widely used method for screening is determination of the BMI . The BMI is weight in kilograms divided by height in meters squared ( BMI = kg/m2 ) ( Table I ) . Most electronic medical records automatically calculate BMI if height and weight are entered . There are also many smart-phone applications and online calculators that can calculate BMI ( for example , http://www.nhlbisupport.com/ bmi ) . Other screening tools include waist circumference and the waist-to-hip ratio . In women , a waist circumference > 35 in ( 88 cm ) or a waist-to-hip ratio > 0.7 indicates excess visceral fat and increased risk for disease . TABLE I. Body Mass Index ( BMI ) Classification Recommendations for screening for diabetes vary by guideline author . The USPSTF recommends screening asymptomatic patients who have blood pressures > 135/80 mmHg . The American Diabetes Association ( ADA ) recommends that individuals who are ≥18 years of age and have a BMI ≥25 kg/m2 and 1 additional risk factor for diabetes should be screened annually ( Table II).3 Individuals over the age of 45 without risk factors should be screened every 3 years . In January 2010 , the ADA released new recommendations for the use of hemoglobin A1C as a screening tool . An A1C greater than 6.5 % indicates diabetes . In addition , the results of screening tests for diabetes can identify individuals with “ prediabetes ” who have a markedly increased risk of developing overt disease.3 TABLE II . American Diabetes Association Recommendations on Screening for Type 2 Diabetes3 Non-Pharmaceutical Treatment Lifestyle-treatment options for diabetes mellitus and excess weight are similar , and 2 recent studies 4,5 have demonstrated the critical components for treating pre-diabetes and diabetes through weight loss , using caloric restriction and physical activity . The 1st study was the Diabetes Prevention Program.4 The purpose of the study was to identify individuals who were at risk for developing diabetes because of elevated fasting plasma glucose or impaired glucose tolerance levels that were not yet in the diagnostic range , in order to determine if metformin or an intensive lifestyle intervention could delay or prevent the onset of diabetes . More than 3,000 individuals with prediabetes were r and omized to receive placebo , metformin , or a 16-session lifestyle-modification program . The intensive lifestyle program set a goal of 7 % weight loss and 150 min/wk of moderate physical activity . Fifty percent of the lifestyle-intervention group lost 7 % of their body weight . The 3-year incidence of diabetes in the metformin group was 31 % lower than that in the placebo group . The incidence was 58 % lower in the lifestyle group than in the placebo group.4 The clinical implication s of this study are that we should 1 ) identify individuals with pre-diabetes and 2 ) recommend lifestyle modifications that result in a 7 % weight loss and include 150 min/wk of moderate physical activity . The 2nd study that examined lifestyle treatment of diabetes and obesity is the Look AHEAD Trial . The purpose of the study was to determine the effect of intentional weight loss on cardiovascular risk factors in individuals with diabetes . Approximately 5,100 individuals with type 2 diabetes and an elevated BMI were r and omized . Study conditions specified a 36-session intensive lifestyle intervention with the option of using partial meal replacements for caloric restriction or 4 sessions of st and ard diabetes support and education ( DSE ) . At 1 year , 55 % of the intensive-lifestyle-intervention group achieved 7 % weight loss . Hemoglobin A1C , systolic and diastolic blood pressure , and lipids improved significantly more in the intensive-lifestyle group than in the DSE group.5 The clinical implication of this study is that intentional weight loss of at least 7 % can improve the cardiovascular risk profile of patients with type 2 diabetes . Conclusions Excess weight affects two thirds of the U.S. adult population and increases risk for cardiovascular disease and diabetes . All patients should be screened for obesity and most should be screened for pre-diabetes and diabetes . The best treatment for diabetes is prevention . Prevention of diabetes can be accomplished through a 7 % weight loss through intensive lifestyle interventions that include caloric reduction and approximately 30 min of daily moderate physical activity . Practitioners will have access to these evidence -based programs soon . The Centers for Disease Control and Prevention are promoting community-based diabetes prevention programs throughout the country",
"OBJECTIVE Biliopancreatic diversion ( BPD ) restores normal glucose tolerance in a few weeks in morbid obese subjects with type 2 diabetes , improving insulin sensitivity . However , there is less known about the effects of BPD on insulin secretion . We tested the early effects of BPD on insulin secretion in obese subjects with and without type 2 diabetes . METHODS AND PROCEDURES Twenty-one consecutive morbid obese subjects , 9 with type 2 diabetes ( T2DM ) and 12 with normal fasting glucose ( NFG ) were evaluated , just before and 1 month after BPD , by measuring body weight ( BW ) , glucose , adipocitokines , homeostasis model assessment of insulin resistance ( HOMA-IR ) , acute insulin response ( AIR ) to e.v . glucose and the insulinogenic index adjusted for insulin resistance ( [DeltaI5/DeltaG5]/HOMA-IR ) . RESULTS Preoperatively , those with T2DM differed from those with NFG in showing higher levels of fasting glucose , reduced AIR ( 57.9 + /- 29.5 vs. 644.9 + /- 143.1 pmol/l , P adjusted insulinogenic index ( 1.0 + /- 0.5 vs. 17.6 + /- 3.9 1/mmol(2 ) , P BW was reduced ( by approximately 11 % ) , but all subjects were still severely obese ; HOMA-IR and leptin decreased significanlty , while high-molecular weight ( HMW ) adiponectin and adjusted insulinogenic index increased . In the T2DM group , fasting glucose returned to non-diabetic values . AIR did not change in the NFG group , while in the T2DM group it showed a significant increase ( from 58.0 + /- 29.5 to 273.8 + /- 47.2 pmol/l , P AIR percentage variation from baseline was significantly related to changes in fasting glucose ( r = 0.70 , P = 0.02 ) , suggesting an important relationship exists between impaired AIR and hyperglycaemia . DISCUSSION BPD is able to restore AIR in T2DM even just 1 month after surgery . AIR restoration is associated with normalization of fasting glucose concentrations",
"CONTEXT The insulin-mimetic adipocytokine visfatin has been linked to obesity . The influence of weight loss on plasma visfatin concentrations in obese subjects is unknown yet . OBJECTIVES In this study we investigated whether plasma visfatin concentrations are altered by weight loss in patients with obesity . DESIGN AND PATIENTS In a prospect i ve study , fasting plasma visfatin , leptin , and adiponectin concentrations were measured before and 6 months after gastric b and ing in 31 morbidly obese patients aged 40 + /- 11 yr with a body mass index ( BMI ) of 46 + /- 5 kg/m(2 ) . Fourteen healthy subjects aged 29 + /- 5 yr with a BMI less than 25 kg/m(2 ) served as controls . RESULTS Visfatin plasma concentrations were markedly elevated in obese subjects ( 0.037 + /- 0.008 microg/ml ) , compared with controls ( 0.001 + /- 0.000 microg/ml , P b and ing reduced BMI to 40 + /- 5 kg/m(2 ) , visfatin to 19.2 + /- 10.9 ng/ml , and leptin from 39.0 + /- 12.4 to 29.7 + /- 10.0 ng/ml and increased adiponectin from 0.015 + /- 0.007 to 0.017 + /- 0.007 microg/ml ( all P Insulin sensitivity as estimated by the homeostasis model assessment insulin resistance index was unchanged from 5.8 + /- 3.1 to 4.6 + /- 1.9 ( P = 0.13 ) , but individual changes of insulin resistance and visfatin were significantly associated ( P plasma visfatin concentrations in morbidly obese subjects are reduced after weight loss . This may be related to changes in insulin resistance over time",
"BACKGROUND Grade D evidence supports a daily protein intake ( DPI ) of > 60 g/d after Roux-en-Y gastric bypass . However , the physiologic effects of this recommendation have yet to be eluci date d. The primary aim of the present study was to assess the effects of DPI after laparoscopic Roux-en-Y gastric bypass on weight loss , leptin levels , and albumin levels . The setting was a 617-acute inpatient bed university-affiliated teaching hospital . METHODS The data from 427 consecutive bariatric surgery patients were prospect ively collected from December 2007 to April 2011 . The data were analyzed using Pearson 's correlation , the chi-square test , the paired t test , analysis of covariance , and hierarchical linear regression analysis . RESULTS Of the 427 patients , 167 ( 39.1 % ) had complete data at 3 , 6 , and 12 months of follow-up and were used for the present analysis . Of the 427 patients , 140 ( 83.8 % ) were women with a mean age and preoperative body mass index ( BMI ) of 42.7 ± 11 years and 47.3 ± 8.1 kg/m(2 ) , respectively . Of the 427 patients , 71.3 % were compliant with a DPI of ≥1 g/kg/d at 12 months postoperatively . The patients had a mean percentage of excess weight loss of 74.9 % ± 16.7 % and a mean BMI of 29.4 ± 5.4 kg/m2 at 12 months . When controlling for the preoperative BMI , carbohydrate violations , and exercise increase , DPI was associated with a greater percentage of excess weight loss ( P = .001 ) , BMI change ( P .0001 ) , and percentage of lean mass ( P = .003 ) , and a lower percentage of body fat ( P after laparoscopic Roux-en-Y gastric bypass is feasible and might result in the benefits of increased weight loss , a decreased percentage of body fat , and improved percentage of lean mass",
"Introduction Morbid obesity and obstructive sleep apnea ( OSA ) interact at an inflammatory level . Bariatric surgery reduces inflammatory responses associated with obesity . Heme oxygenase-1 ( HO-1 ) is an enzyme with anti-inflammatory properties , which might be increased in morbid obesity or OSA . We studied morbidly obese patients with OSA to determine : ( a ) HO-1 plasma concentrations according to OSA severity and their relationship with insulin resistance and inflammation and ( b ) the impact of bariatric surgery on HO-1 and parameters of insulin resistance and inflammation . Material and Methods We analyzed the homeostasis model insulin resistance index ( HOMA ) and plasma concentrations of HO-1 , tumor necrosis factor alpha , interleukin-6 , interleukin-1-beta , C reactive protein ( CRP ) , and adiponectin according to polysomnography findings in 66 morbidly obese patients before bariatric surgery and 12 months after surgery . Results Before surgery , HO-1 plasma concentrations were similar in three groups of patients with mild , moderate , and severe OSA , and correlated with HOMA ( r = 0.27 , p = 0.02 ) . Twelve months after surgery , low- grade inflammation and insulin resistance had decreased in all the groups , but HO-1 plasma concentration had decreased only in the severe OSA group ( p = 0.02 ) . In this group , the reduction in HO-1 correlated with a reduction in CRP concentrations ( r = 0.43 , p = 0.04 ) and with improved HOMA score ( r = 0.37 , p = 0.03 ) . Conclusions Bariatric surgery decreases HO-1 concentrations in morbid obesity with severe OSA , and this decrease is associated with decreases in insulin resistance and in inflammation"
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41172a08-06ff-11f0-808a-c43d1ab1c353
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Purpose To critically appraise and compare the measurement properties of the original versions of neck-specific question naires . Methods Bibliographic data bases were search ed for articles concerning the development or evaluation of the measurement properties of an original version of a self-reported question naire , evaluating pain and /or disability , which was specifically developed or adapted for patients with neck pain . The method ological quality of the selected studies and the results of the measurement properties were critically appraised and rated using a checklist , specifically design ed for evaluating studies on measurement properties . Results The search strategy result ed in a total of 3,641 unique hits , of which 25 articles , evaluating 8 different question naires , were included in our study . The Neck Disability Index is the most frequently evaluated question naire and shows positive results for internal consistency , content validity , structural validity , hypothesis testing , and responsiveness , but a negative result for reliability . The other question naires show positive results , but the evidence for each measurement property is mostly limited , and at least 50 % of the information on measurement properties per question naire is lacking . Conclusions Our findings imply that studies of high method ological quality are needed to properly assess the measurement properties of the currently available question naires . Until high quality studies are available , we recommend using these question naires with caution . There is no need for the development of new neck-specific question naires until the current question naires have been adequately assessed
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[
"Background The COSMIN checklist is a tool for evaluating the method ological quality of studies on measurement properties of health-related patient-reported outcomes . The aim of this study is to determine the inter-rater agreement and reliability of each item score of the COSMIN checklist ( n = 114 ) . Methods 75 articles evaluating measurement properties were r and omly selected from the bibliographic data base compiled by the Patient-Reported Outcome Measurement Group , Oxford , UK . Raters were asked to assess the method ological quality of three articles , using the COSMIN checklist . In a one-way design , percentage agreement and intraclass kappa coefficients or quadratic-weighted kappa coefficients were calculated for each item . Results 88 raters participated . Of the 75 selected articles , 26 articles were rated by four to six participants , and 49 by two or three participants . Overall , percentage agreement was appropriate ( 68 % was above 80 % agreement ) , and the kappa coefficients for the COSMIN items were low ( 61 % was below 0.40 , 6 % was above 0.75 ) . Reasons for low inter-rater agreement were need for subjective judgement , and accustom to different st and ards , terminology and definitions . Conclusions Results indicated that raters often choose the same response option , but that it is difficult on item level to distinguish between articles . When using the COSMIN checklist in a systematic review , we recommend getting some training and experience , completing it by two independent raters , and reaching consensus on one final rating . Instructions for using the checklist are improved",
"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",
"OBJECTIVE This study compares the sensitivity to change of the Neck Disability Index ( NDI ) and the Neck Bournemouth Question naire ( NBQ ) in patients with chronic uncomplicated neck pain . METHODS This prospect i ve longitudinal study was completed in an outpatient physical therapy clinic . Subjects , with uncomplicated neck pain ( no concurrent shoulder pain or nerve root symptoms ) for more than a 3-month duration , participated in a 4-week course of therapy that included moist heat , neck exercises , and either mobilization or massage . Outcome measures included st and ardized response means ( sensitivity to change ) , Cronbach alpha ( internal consistency ) , and 2-way Spearman correlations between the 2 question naires and between a pain Visual Analog Scale and each question naire ( convergent validity ) . RESULTS Mean ( SD ) score change of the NDI was 6.22 ( 5.12 ) , and of the NBQ , 14.00 ( 11.99 ) . St and ardized response means were 1.21 and 1.17 , respectively . Both question naires were more sensitive to change than the pain Visual Analog Scale ( 0.68 ) . There was moderate correlation between the change scores of all 3 outcome tools ( Spearman 0.46 - 0.57 ) . The NBQ had higher internal consistency than the NDI . CONCLUSIONS The NDI and the NBQ performed comparably in this group of patients with chronic uncomplicated neck pain . Both are sensitive to change and would be efficient outcome tools in studies of chronic neck pain . Both had acceptable internal consistency and are appropriate for use as single- outcome scales",
"OBJECTIVE Develop and test a short-form comprehensive outcome measure for back pain . DESIGN Prospect i ve longitudinal study of 3 consecutive cohorts of back pain patients . SETTING Anglo-European College of Chiropractic outpatient clinic and several field chiropractic practice s. METHOD Domains judged important in the back pain model and responsive to clinical change were identified from the literature . Items were scored on an 11-point numerical rating scale . The instrument was psychometrically tested by use of those tests relevant to an evaluative measure . RESULTS Seven dimensions of the back pain model were included in the question naire . Having established face validity , the instrument was shown to demonstrate high internal consistency ( Cronbach 's alpha = 0.9 ) and good test-retest reliability ( ICC = 0.95 ) . All items were retained on the basis that they contributed to the overall score ( item-corrected total score correlations ) and to the instrument 's responsiveness to clinical change ( item change-corrected total change score correlations ) . The instrument demonstrated acceptable construct and longitudinal construct validity with established external measures . The effect size of the instrument was high ( 1.29 ) and comparable with established measures . CONCLUSION A reliable , valid , and responsive instrument has been developed for use in back pain patients . It is practical for use in investigations of both the efficacy and effectiveness of back pain treatments",
"PURPOSE Report the test-retest reliability , construct validity , minimum clinical ly important difference ( MCID ) , and minimal detectable change ( MDC ) for the Neck Disability Index ( NDI ) . STUDY DESIGN / SETTING Cohort study of patients presenting to outpatient physical therapy clinics . PATIENT SAMPLE Ninety-one subjects with a primary complaint of neck pain , with or without concomitant upper extremity ( UE ) symptoms , who were participants in a r and omized clinical trial . OUTCOME MEASURES NDI and the 15-point Global Rating of Change ( GRC ) self-report measures . METHODS All subjects completed the NDI at baseline and at a 3-week follow-up . Additionally , subjects completed the GRC scale , which was used to dichotomize patients into improved or stable groups . Changes in the NDI were used to assess test-retest reliability , construct validity , MCID , and MDC . RESULTS Test-retest reliability was moderate for the NDI ( intraclass correlation coefficient , 0.64 ; 95 % confidence interval , 0.19 - 0.84 ) . For the NDI , the MCID was 7.5 points and the MDC was 10.2 points . CONCLUSIONS The NDI appears to demonstrate adequate responsiveness based on statistical reference criteria when used in a sample that approximates the high percentage of patients with neck pain and concomitant UE referred symptoms . Because the MCID is within the bounds of measurement error , a 10-point change ( the MDC ) should be used as the MCID",
"Study Design . Prospect i ve , single-cohort study . Objective . To determine the relative sensitivity of a range of outcome measures used in evaluating treatment interventions in patients with neck pain and the magnitude of change scores on the neck Bournemouth Question naire and the cutoff score on the Patients ’ Global Impression of Change scale associated with clinical ly significant improvement . Summary of Background Data . Traditionally , evaluation of treatment interventions using subjective outcome measures has been based on the statistical significance of the difference between group mean values . To be clinical ly meaningful , however , information is required from sensitive outcome measures on the proportion of patients undergoing a clinical ly important improvement and from this , the number needed to treat for a single patient to benefit . Methods . Patients with nonspecific neck pain from a number of treatment centers completed a battery of self-report question naires , including the Bournemouth Question naire , before and after chiropractic treatment . After treatment , patients also completed a retrospective analysis of their overall improvement since the start of treatment ( Patients ’ Global Impression of Change ) . The a priori definition of clinical ly significant improvement was defined as a Reliable Change Index on the Bournemouth Question naire of > 1.96 . Results . The best cutoffs with a balance between the highest sensitivity and highest specificity in detecting clinical improvement were a score of 2 or less on the Patients ’ Global Impression of Change ( 11-point Numerical Rating Scale : 0 = much better , 5 = no change , and 10 = much worse ) and a raw change score of three or more points on each of the seven 11-point Numerical Rating Scale subscales of the Bournemouth Question naire . For the total score of the Bournemouth Question naire , raw change scores of 13 or more points , percentage change scores of 36 % or more , and individual effect sizes of 1.0 or more were all associated with clinical ly significant improvement . The sensitivity of the Bournemouth Question naire in terms of its effect size was comparable with that of pain intensity scales and the Neck Disability Index . Conclusions . The present findings will assist in the choice of outcome measures in trials on neck pain . The study also illustrates a method ologic framework for interpreting change scores in terms of clinical improvement , facilitating the process of making sense of research data in the clinical setting",
"Study Design . Patients enrolled in a r and omized controlled trial were asked to complete various question naires , which were then compared to establish validity for a new neck pain question naire . Objectives . To vali date a new and brief outcome measure for use with patients with mechanical neck pain . Summary of Background Data . Neck pain is a very common problem and one that clinicians will be required to treat with some regularity . In today ’s climate of evidence -based practice and the need to quantify and justify clinical intervention , a quick and easy method to evaluate progress is required . Such a measure has already been produced for those experiencing back pain , but as yet , there is no such measure for neck pain and this needs to be addressed . Methods . The back pain measure was adapted to enable its use with patients with neck pain . Repeatability was assessed by using a 1-week test/retest on 104 patients who were enrolled in a neck pain trial . Validity was assessed by comparing the new question naire against other already well vali date d measures ( i.e. , the Neck Disability Index and a Visual Analogue Scale for pain ) with 133 patients . Results . The test/retest showed excellent repeatability with high intraclass correlations and P validity , giving close agreement to the other comparison measures . Conclusion . The short Core Neck Pain Question naire has been demonstrated to be repeatable and valid as a brief outcome measure for use with patients with mechanical neck pain",
"OBJECTIVE To modify an existing outcome measure ( Bournemouth Question naire [ BQ ] ) for use in patients with nonspecific neck pain and test its psychometric properties . DESIGN Prospect i ve longitudinal study in which the question naire was administered on 3 occasions ( pretreatment , retest , and posttreatment ) . SETTING Anglo-European College of Chiropractic outpatient clinic and 8 field chiropractic practice s. METHOD Seven core items relating to the biopsychosocial model of pain were included in the original question naire ( back BQ ) . The wording of one of these items ( disability in activities of daily living ) was modified to include activities likely to be affected by neck pain . Testing of the neck BQ was carried out in 102 patients with nonspecific neck pain . RESULTS The instrument demonstrated high internal consistency on 3 administrations ( Cronbach 's alpha = 0.87 , 0.91 , 0.92 ) . All 7 items were retained on the basis that they each significantly contributed to the total score ( item-corrected total score correlations > 0.43 ) and to the instrument 's responsiveness to clinical change ( item change-corrected total change score correlations > 0.42 ) . The instrument was reliable in test-retest administrations in stable subjects ( ICC = 0.65 ) . The instrument demonstrated acceptable construct validity and longitudinal construct validity with established external measures . The treatment effect size of the instrument was found to be high ( 1.67 ) . CONCLUSION The neck BQ covers the salient dimensions of the biopsychosocial model of pain , is quick and easy to complete , and has been shown to be reliable , valid , and responsive to clinical ly significant change in patients with nonspecific neck pain . Its use as an outcome measure in clinical trials and outcomes research is recommended",
"Objectives To estimate the sensitivity to change and internal consistency of the Northwick Park Neck Pain Question naire ( NPQ ) and derive its minimal clinical ly important difference ( MCID ) . Methods Data on 311 participants in a r and omized controlled trial of physical therapy for neck pain were analyzed , between baseline and 6-month follow-up . Cronbach α was used to estimate internal consistency . Three methods of evaluating the NPQ 's sensitivity to change were used ; Cohen 's effect size , st and ardized response mean , and Guyatt 's responsiveness statistic . The smallest change on the NPQ that can be construed as clinical ly important ( the MCID ) was obtained by ( 1 ) comparing values derived from different methods that account for the measurement error of the question naire with improvements in other neck pain-specific measures , and then ( 2 ) examining the impact of the addition of an independent measure ( “ anchor ” ) relating to participants ' subjective rating of improvement . Results Cronbach α was 0.79 for the whole scale . Using all participants , Cohen 's d was 0.78 , st and ardized response mean was 0.71 , and Guyatt 's responsiveness statistic was 0.93 . Using only participants who stated they had improved , the estimates were 1.35 , 1.27 , 1.45 , respectively . The MCID for the NPQ was determined as a 25 % reduction in score from baseline together with a patient 's global rating of their neck pain of at least “ better . ” Conclusions These results show high internal consistency and sensitivity to change for the NPQ , and provide an MCID that allows participants with varying levels of severity to demonstrate improvement",
"A method is described for evaluating the progress of patients with back pain . Various symptoms were scored on analogue scales and spinal motion was measured by various techniques . These data were integrated to make subjective and objective indices respectively . Reasonable reproducibility of the measurements was obtained . This technique was used to eluci date the role of the lumbar support in surgical corsets in relief of back pain . Sufferers from back pain were r and omly allocated to corsets with and without lumbar supports . There was significant improvement in those with a support compared with those without . On the other h and objective changes measured with the corset removed did not differ between the 2 groups . This study indicates that the spinal support in a lumbosacral corset makes a significant contribution towards the relief of symptoms"
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41172a44-06ff-11f0-808a-c43d1ab1c353
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Purpose The objective of this systematic review is to compare results concerning the properties of adhesion , roughness , and hardness of dental liners obtained in the last ten years . Methods Search es on the data bases LILACS , PubMed / Medline , Web of Science , and Cochrane Data base of Systematic Review s were supplemented with manual search es conducted between February and April of 2018 . The inclusion criteria included experimental in vitro and in vivo , clinical , and laboratory studies on resilient and /or hard liners , assessment of hardness , roughness , and /or adhesion to the denture base , and physical/mechanical changes result ing from the disinfection process and changes in liners ' composition or application . Results A total of 406 articles were identified and , from those , 44 are discussed . Twenty-four studies examined the bond strength , 13 surface roughness , and 19 the hardness . Of these 44 studies , 12 evaluated more than one property . Different substances were used in the attempt to improve adhesion . Considering roughness and hardness , the benefits of sealants have been tested , and the changes result ing from antimicrobial agents ' incorporation have been assessed . Conclusion Adhesion to the prosthesis base is improved with surface treatments . Rough surfaces and changes in hardness compromise the material 's serviceability
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[
"OBJECTIVE This study evaluated colour stability , hardness and roughness of soft denture liners after immersion in various cleansers . MATERIAL S AND METHODS Thirty specimens ( 14 mm × 4 mm ) of Elite Soft Relining ( ES ) and Mucopren Soft ( MS ) were r and omly immersed in distilled water at 37 ° C , sodium hypochlorite 1 % , and an experimental Ricinus communis solution ( RC ) for 7 , 15 and 183 continuous days . RESULTS anova ( p presented a higher increase in hardness than ES . After T7 , MS underwent an increase in roughness ( μ = 0.09 ± 0.80 ) ; ES underwent a decrease ( μ = -0.08 ± 0.16 ) . RC caused the smallest variation in roughness . After T15 , both material s presented an increase in roughness . After T183 , ES ( μ = -0.30 ± 0.48 ) presented a higher roughness variation than MS ( μ = -0.07 ± 0.32 ) . Hypochlorite caused an increase in roughness ( μ = 0.02 ± 0.19 ) . CONCLUSION After all periods ES presented higher colour alteration than MS ; highest colour alteration was caused by hypochlorite . Both material s were more stable after immersion in RC",
"PURPOSE This r and omized clinical trial assessed how surface roughness ( Ra ) in resilient liners was affected by soft tissue health conditions and time-related aspects in patients with complete dentures . METHODS Specimens of acrylic resin ( control ) and denture liners ( silicone-based or acrylic resin-based ) were inserted into the dentures of patients with and without denture stomatitis ( n = 30 ) . Ra was evaluated before denture insertion and after 7 , 14 , and 21 days of prosthesis wearing . Data were analyzed using three-way analysis of variance and Student-Newman-Keuls test . RESULTS Patients with stomatitis showed a higher Ra ( P rougher surfaces after 14 days of clinical service , irrespective of the soft tissue health condition . CONCLUSION Ra of the tested denture liners was increased in patients with denture stomatitis . It is presumed that a longer wearing period will result in rougher surfaces",
"OBJECTIVE The aim of the present study was to evaluate the clinical performance of four denture soft liners up to 12 months . MATERIAL S AND METHODS Thirty-three edentulous patients who experienced difficulties when using hard denture bases because of changes in denture-supporting tissues were accepted for the study and r and omly received Molloplast B , GC Reline Soft , Silagum Comfort , or Mollosil Plus relines . Performance of the material s was evaluated using nine criteria at 3 , 6 , and 12 months : physical integrity , surface detail , adhesion , color , odor , plaque accumulation , resilience , hygiene , and mucosal condition . A four-point categorized scale ( 1=poor , 2=fair , 3=good , 4=excellent ) was used . Unscheduled maintenance events and the presence of fungal colonization were also recorded . RESULTS The percentage of patients available at 3 , 6 , and 12 months were 91 % , 91 % , and 66 % . Main reasons for dropouts and discontinuation were fractured dentures and patient dissatisfaction . At 6 months , 96 % of the performance scores were good or excellent and the largest changes were observed for physical integrity , surface detail , color , and fungal colonization . Fungal colonization was the most commonly observed problem and was the only reason of failure at 12 months . CONCLUSIONS The clinical performance of all soft liners was slightly impaired over the 12-month observation . Except for cases showing extensive fungal colonization , the observed changes in clinical performance did not necessitate remaking of the dentures . Mollosil Plus showed a performance comparable to that of Molloplast B , and the other material s had slightly lower performance especially in terms of fungal colonization",
"OBJECTIVES This r and omised clinical trial assessed how biofilm development and composition is affected by time and denture material type in denture wearers with and without denture stomatitis . METHODS Specimens of acrylic resin ( control ) and denture liners ( silicone-based or acrylic resin based , depending on the experimental phase ) were inserted into the surface intaglio of 30 denture wearers . Biofilm was formed in two phases of 21 days , and counts of viable micro-organisms in the accumulating biofilm were determined after 7 , 14 and 21 days of biofilm formation . Data were analysed by three-way ANOVA followed by Tukey test to assess differences among health condition ( healthy or with denture stomatitis ) , material s and time point . RESULTS Non-albicans C and ida species counts were higher in diseased patients with silicone-based denture liners ( p=0.01 ) . Denture stomatitis patients showed higher mutans streptococci counts after 7 days ( p=0.0041 ) . CONCLUSIONS Longer biofilm formation time periods did not result in differences on biofilm composition . The denture liners evaluated in this study accumulate greater amount of biofilm , and therefore their use should be carefully planned . CLINICAL SIGNIFICANCE The silicone-based denture liner tested should be used cautiously in patients with denture stomatitis as it showed increased non-albicans species counts , known to be difficult to treat"
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41172a8a-06ff-11f0-808a-c43d1ab1c353
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INTRODUCTION Erectile dysfunction ( ED ) is an increasing health problem that dem and s effective treatment . There is evidence that phosphodiesterase-5 inhibitors ( PDE5-Is ) and psychological intervention ( PI ) are effective treatment options ; however , little is known about their comparative efficacy and the efficacy of combined treatments . AIM The aim of this systematic review and meta- analysis is to evaluate the comparative efficacy of PI , PDE5-Is , and their combination in the treatment of ED . MAIN OUTCOME MEASURES Primary outcome was ED symptoms , and secondary outcome was sexual satisfaction of the patient . METHODS A systematic literature search was conducted in order to identify relevant articles published between 1998 and 2012 . We included r and omized controlled trials and controlled trials comparing PI with PDE5-I treatment or one of them against a combination of both . RESULTS Eight studies with a total number of 562 patients were included in the meta- analysis . The results of the included studies are inconclusive , though they show a trend towards a larger effect of combined treatment compared with PI or PDE5-I treatment alone . The meta- analysis found that , overall , combined treatment was more efficacious for ED symptoms than PDE5-I treatment or PI alone . Combined treatment was more efficacious than PDE5-I use alone on sexual satisfaction . No differences were found between PDE5-Is and PI as st and -alone treatments . None of the moderators ( treatment duration , method ological quality , or research er allegiance ) altered the effects . CONCLUSIONS The combination of PI and PDE5-Is is a promising strategy for a favorable outcome in ED and can be considered as a first-choice option for ED patients . Stronger RCTs are required to confirm this initial finding
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[
"We investigated the effect of adding a psychoeducational intervention to oral sildenafil ( PsychoedPlusMed ) in the treatment of erectile dysfunction ( ED ) . Overall treatment satisfaction , as measured by the Erectile Dysfunction Inventory of Treatment Satisfaction ( EDITS ; Althof & Seftel , 1995 ) , was significantly higher in the PsychoedPlusMed patients than in the sildenafil-only patients at 12 weeks and at 24 weeks . PsychoedPlusMed participants reported higher satisfaction with treatment onset , treatment duration , and sexual confidence . PsychoePlusMed participants also reported an increase in communication about sex with their partner . A brief psychoeducational intervention can improve treatment satisfaction with sildenafil therapy for ED",
"INTRODUCTION Sexual satisfaction is linked to life satisfaction , and erectile dysfunction ( ED ) may lead to an impaired quality of life ( QOL ) . AIM Our goal was to evaluate the QOL among Brazilian patients with ED , before and after three kinds of treatment . METHODS Men aged 25 - 55 years , with a diagnosis of psychogenic or mixed ED , according to the Classification of Mental and Behavioral Disorders of the International Classification of Diseases , 10th edition , and the St and ard Practice in Sexual Medicine , were r and omly assigned to three treatment groups : counseling , sildenafil , and sildenafil plus counseling . At baseline each group had 40 patients . Sildenafil was provided in 50 mg that could be adjusted to 100 mg . The patients could initially take one to two tablets per week and the entire treatment lasted for 3 months . Counseling was provided in group sessions that took place once a week . They were evaluated at baseline and after 3 months of treatment with the Male Sexual Quotient ( MSQ ) and the Sexual Health Inventory for Men ( SHIM ) . MAIN OUTCOME MEASURES The correlation between the patients ' MSQ score and scores on the SHIM . RESULTS One hundred seventeen patients were enrolled . The three groups were similar according to age , marital status , mean time of ED , and ED severity and etiology . At baseline , MSQ and SHIM total scores were not different among the three groups . MSQ scores increased from 41.2 + /- 15.3 , 38.7 + /- 18.0 , and 46.8 + /- 17.0 to 48.5 + /- 15.3 , 63.8 + /- 21.6 , and 70.0 + /- 17.3 after counseling , sildenafil , and sildenafil plus counseling , respectively ( P SHIM scores also increased significantly ( 9.6 + /- 4.1 , 9.7 + /- 4.1 , and 10.2 + /- 3.9 to 12.1 + /- 3.9 , 16.7 + /- 5.6 , and 17.7 + /- 4.5 after counseling , sildenafil , and sildenafil plus counseling , respectively ) ( P serious adverse events related to sildenafil , and no patient was withdrawn from the study because of an adverse event . CONCLUSIONS The three treatments were significantly efficient , and the best treatment was sildenafil associated with counseling",
"We admistered the International Index of Erectile Function ( IIEF ; Rosen et al. , 1997 ) question naire to 30 patients with psychogenic erectile dysfunction ( ED ) at baseline , immediately after treatment , and 3 months after treatment . We r and omized patients into three groups : group I , who had weekly sessions of time-limited theme-based group psychotherapy for 6 months and 50 mg sildenafil citrate orally on dem and ; group II , who had an intake of 50 mg sildenafl citrate orally on dem and for 6 months only ; and group III , who had weekly sessions of time-limited theme-based group psychotherapy for 6 months . We analyzed data ( 15-item IIEF ) for each group at three times during the study and compared by the data using analysis of variance ( ANOVA ) , followed by the Bonferroni multiple comparison test . We used Cochran 's Q-test for analysis between baseline and posttreatment stages of patients with remission of symptoms ( EF equal to or higher than 26 points ) . Group III had a mean score higher than group II , with the difference being statistically significant ( immediately after treatment , p = 0.033 ; at 3 months after treatment , p = 0.049 ; p improvement of erectile function domain score . However , significant differences from baseline were observed in groups I ( p = 0.0009 ) and III ( p = 0.0002 ) but not in group II ( p = 0.135 ) . The psychotherapy groups , I and III , had significantly higher scores compared with group II , in which patients were exclusively treated with sildenafil citrate . These findings suggest that time-limited theme-based group psychotherapy is an effective treatment for psychogenic ED",
"Erectile dysfunction ( ED ) is commonly associated with depressed mood and diminished quality of life ( QoL ) , but few studies have investigated the causal associations involved . Therefore , we evaluated the correlation between several measures of mood , QoL , and sexual function in a retrospective analysis of a sample of depressed men ( n=152 ) , with ED enrolled in a clinical trial of sildenafil citrate ( VIAGRA ® ) . Strong correlations were observed at baseline among measures of erectile function ( EF ) , mood , and overall QoL. Significant treatment effects were observed on all three domains , with significant interactions between changes in mood and QoL. Based on multiple regression and path analysis , a model was developed in which EF changes were associated with improved mood and quality of sexual life , which result ed in improved partner satisfaction , family life , and overall life satisfaction . These data suggest that QoL changes associated with ED therapy may be mediated by changes in sexual function , mood , and family relationships",
"Treatment options for managing erectile dysfunction ( ED ) include medical and psychological interventions . The present study examined the effectiveness of a drug-only vs. combined treatment approach on erectile function as well as other domains of sexual function and cognition , couple intimacy and adaptation , and treatment satisfaction . Couples with ED were r and omly assigned to either Viagra-only ( VO ) or Viagra plus sex therapy ( VST ) . Sexual and relationship variables were measured at specific time points . Despite limitations , study findings extend previous conclusions and provide empirical support for the effectiveness and satisfaction with the combined treatment approach for treating men with ED of mixed etiology",
"OBJECTIVES To develop Patient and Partner versions of a psychometrically sound question naire , the EDITS ( Erectile Dysfunction Inventory of Treatment Satisfaction ) , to assess satisfaction with medical treatments for erectile dysfunction . METHODS Treatment satisfaction differs from treatment efficacy as it focuses on a person 's subjective evaluation of treatment received . Twenty-nine items representing the domain of treatment satisfaction for men and 20 representing partner satisfaction were generated . Two independent sample s of 28 and 29 couples completed all items at two points in time . Spearman rank-order correlations were derived to assess test-retest reliability and couple coefficients of validity . Internal consistency coefficients were calculated for both Patient and Partner versions and a content validity panel was used to analyze content validity . RESULTS Only items that met all the following criteria were selected to comprise the final question naires : ( a ) range of response four or more out of five ; ( b ) test-retest reliability greater than 0.70 ; ( c ) ratings by at least 70 % of the content validity panel as belonging in and being important for the domain ; and ( d ) significant correlation between the subjects ' and partners ' responses . Eleven patient items met criteria and formed the Patient EDITS ; five partner items met criteria and formed the Partner EDITS . Scores on the two inventories were normally distributed with internal consistencies of 0.90 and 0.76 , respectively . Test-retest reliability for the Patient EDITS was 0.98 ; for the Partner EDITS , it was 0.83 . CONCLUSIONS Reliability and validity were well established , enabling the EDITSs to be used to assess satisfaction with treatment modalities for erectile dysfunction and to explore the impact of patient and partner satisfaction on treatment continuation",
"OBJECTIVES To discuss the therapeutic choices of erectile dysfunction ( ED ) and to improve the therapeutic efficacy for different ED cases . METHODS Two hundred and twenty-seven patients with ED were treated repectively with psychological treatment(31 cases ) , oral testosterone(30 cases ) , Viagra(121 cases ) , psychological treatment + Viagra ( 16 cases ) , intraurethral PGE1 ( 8 cases ) and intracavemous injection(21 cases ) . RESULTS Among those ED patients , 142 ( 62.6 % ) cases reported improved erections after they had undergone above-mentioned therapies . The improved patients include 12 cases(38.7 % ) with psychological treatment , 9 cases ( 30.0 % ) with oral testosterone , 91 cases ( 75.2 % ) with Viagra , 13 cases ( 81.3 % ) with psychological and Viagar , 2 cases ( 25.0 % ) with intraurethral PGE1 and 21 cases ( 71.4 % ) with intracavemous injection . CONCLUSIONS ED is a highly individualized disease , therapeutic choices of ED based on patient 's situation can benefit those patients",
"OBJECTIVE The aim of Phase II of the Men 's Attitudes to Life Events and Sexuality ( MALES ) Study is to explore PDE5 inhibitor treatment seeking among men with erectile dysfunction ( ED ) . METHODS Phase II of the MALES study involved 2,912 men , aged 20 - 75 years , from 8 countries ( U.S. , U.K. , Germany , France , Italy , Spain , Mexico , and Brazil ) , who reported ED . Participants were recruited from the MALES Phase I sample [ 1 ] and via booster methods ( e.g. , physician referral , street interception ) , and completed self-report question naires concerning the characteristics of their ED , their efforts to seek PDE5 inhibitor treatment for their sexual dysfunction , and attitudinal and referent influences that potentially affect treatment-seeking . Statistical analyses focus on identification of correlates of PDE5 inhibitor treatment seeking . RESULTS PDE5 inhibitor utilization is strongly associated with ED sufferers ' assessment of the severity of their sexual dysfunction , with their belief that medication for ED is dangerous , and with their perceptions of whether physicians , other professionals , and spouses or family members are supportive of their seeking treatment . ED sufferers who evaluate their sexual dysfunction as severe , who believe that medication for ED is not dangerous , and who perceive support for treatment seeking from referent others , are more likely to utilize PDE5 inhibitor treatment . CONCLUSION Findings indicate that perceived ED severity , beliefs about ED medication , and referent influences are strongly correlated with utilization of PDE5 inhibitor therapy . These findings aid our underst and ing of factors that may incline men with ED to seek-or to avoid-PDE5 inhibitor therapy for their sexual dysfunction , and provide a basis for clinical and educational interventions to assist men with ED to seek appropriate treatment",
"INTRODUCTION Men with psychogenic erectile dysfunction ( ED ) present a challenge to physicians . Treatment with pharmacological agents alone does not address the complexities of the causative or result ing psychological issues . AIM To evaluate the effectiveness of an integrative treatment protocol ( ITP ) with sildenafil and cognitive-behavior sex therapy ( CBST ) compared with sildenafil alone for men with psychogenic ED . MAIN OUTCOME MEASURES Change from baseline on the International Index of Erectile Function ( IIEF ) in the domains of erectile function and sexual satisfaction to demonstrate improved sexual functioning and confidence . METHODS Men with psychogenic ED and female partners were r and omized to receive either sildenafil alone or an ITP with sildenafil and CBST for the first 4 weeks . In the last 4 weeks , couples in the sildenafil group added CBST sessions to their regimen ; patients in the ITP group continued the combined therapy . The IIEF question naire was used to compare erectile function and overall satisfaction serially at pretreatment , 4 , and 8 weeks . Couples who met the success criteria in both domains after the first 4 weeks received no further treatment . RESULTS Fifty-three couples constituted the study population . After the first 4 weeks of sildenafil and ITP , 48 % of men met criteria for success on erectile function and 65.5 % for satisfaction compared to men on sildenafil alone with 29 % and 37.5 % success rates , respectively . After the last 4 weeks , integration of CBST with sildenafil result ed in a 58 % success rate for erectile function which was comparable to the 66 % rate for the initial drug/ITP group ; satisfaction rates for men were 45 % and 75 % , respectively . CONCLUSIONS CBST was shown to have a positive influence when used throughout the entire 8 weeks of the ITP or added to the sildenafil in the last 4 weeks . Although patients in both treatment regimens had significant improvements in the IIEF domain scores confirming efficacy of sildenafil , those in the CBST and drug regimen achieved higher rates of clinical success within the first 4 weeks of therapy",
"INTRODUCTION Sexual satisfaction is an important aspect of overall life satisfaction . The Male Sexual Quotient ( MSQ ) was design ed to provide a versatile , user-friendly instrument to measure various aspects of male sexual function and satisfaction . AIM Assess responses to the MSQ in men with sexual dysfunction ( SD ) . METHODS Items for inclusion in the MSQ were developed through interviewing 612 r and omly recruited men in São Paulo , Brazil , about factors considered to influence sexual quality of life . Validation of the MSQ was conducted in two phases in men with and without SD . MAIN OUTCOME MEASURE The correlation between patients ' total MSQ score and scores on the Sexual Health Inventory for Men ( SHIM ) . RESULTS The result ing MSQ question naire contains 10 items that address sexual function and satisfaction and is scored on a 100-point scale , with higher scores indicating greater sexual function and satisfaction with such function . Patients ' scores on the MSQ were positively correlated with scores on the SHIM ( r = 0.86 ; P MSQ item 8 , which assesses ejaculatory control , indicated that 46 % of patients may have premature ejaculation ( PE ) . The mean time for patients to complete the MSQ was 11 minutes . CONCLUSIONS The MSQ is a brief , comprehensive , and easily self-administered tool design ed to help men identify aspects of their sexual experience that could be improved through partner dialogue , physician consultation , and appropriate treatment . MSQ scores correlated well with SHIM scores , and scores were inversely related to the severity of erectile dysfunction or PE and other male SDs . These preliminary findings suggest that the MSQ possesses good convergent validity . Nearly half of men reported problems with ejaculatory control , indicating an association between PE and other SD . Further validation of the MSQ in a double-blind trial is needed . The MSQ may aid in decision making for the treatment of SD"
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Aims Cryoablation is a promising alternative technique to RF ablation for treating paroxysmal AF with encouraging results . However , data about the efficacy and safety comparison between cryoablation and RF ablation is still lacking . Methods and results We systematic ally search the PubMed , the Cochrane Library , MEDLINE and Google Scholar data bases , and finally identify 16 eligible studies including 7195 patients ( 2863 for cryoablation ; 4332 for RF ablation ) . Freedom from AF/atrial tachycardial replase is slightly higher in cryoablation than RF ablation during a median 12 months of follow-up , with no statistical significant ( RR : 1.05 , 95 % CI : 0.98 - 1.13 , P = 0.159 ) . In cryoablation , the procedure time is substantially shortened ( WMD : -27.66 , 95 % CI : -45.24 to - 10.08 , P = 0.002 ) , whereas the fluoroscopy time is identical to RF ablation ( WMD : -0.37 , 95 % CI : -2.78 to 2.04 , P = 0.763 ) . Procedure-related adverse events in cryoablation are parallel with that in RF ablation ( RR : 1.08 , 95 % CI : 0.86 - 1.35 , P = 0.159 ) . Conclusions Compared with RF ablation , cryoablation present a comparable long-term AF/atrial tachycardial-free survival and procedure-related adverse events . Meanwhile , cryoablation markedly shorten the procedure time , nonetheless , with negligible impact on the fluoroscopy time
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"Background —Radiofrequency ( RF ) catheter ablation is limited by thromboembolic complications . The objective of this study was to compare the incidence and characteristics of thrombi complicating RF and cryoenergy ablation , a novel technology for the catheter-based treatment of arrhythmias . Methods and Results —Ablation lesions ( n=197 ) were performed in 22 mongrel dogs at right atrial , right ventricular , and left ventricular sites preselected by a r and omized factorial design devised to compare RF ablation with cryocatheter configurations of varying sizes ( 7F and 9F ) , cooling rates ( −1 ° C/s , −5 ° C/s , and −20 ° C/s ) and target temperatures ( −55 ° C and −75 ° C ) . Animals were pretreated with acetylsalicylic acid and received intraprocedural intravenous unfractionated heparin . Seven days after ablation , the incidence of thrombus formation was significantly higher with RF than with cryoablation ( 75.8 % versus 30.1 % , P = 0.0005 ) . In a multiple regression model , RF energy remained an independent predictor of thrombus formation compared with cryoenergy ( OR , 5.6 ; 95 % CI , 1.7 , 18.1;P = 0.0042 ) . Thrombus volume was also significantly greater with RF than with cryoablation ( median , 2.8 versus 0.0 mm3;P ) . More voluminous thrombi were associated with larger RF lesions , but cryolesion dimensions were not predictive of thrombus size . Conclusions —RF energy is significantly more thrombogenic than cryoenergy , with a higher incidence of thrombus formation and larger thrombus volumes . The extent of hyperthermic tissue injury is positively correlated with thrombus bulk , whereas cryoenergy lesion size does not predict thrombus volume , most likely reflecting intact tissue ultrastructure with endothelial cell preservation",
"BACKGROUND Although radiofrequency ( RF ) ablation has long been the st and ard of care for atrial fibrillation ( AF ) ablation , cryoballoon technology has emerged as a feasible approach with promising results . Prospect i ve multicenter registry data referring to both ablation technologies in AF ablation are lacking so far . OBJECTIVE The purpose of this study was to report data from the German ablation registry with respect to efficacy and safety in pulmonary vein ablation with different energy sources for paroxysmal AF after 1-year follow-up . METHODS A total of 2306 patients with symptomatic paroxysmal AF from the German ablation registry were included in this analysis . The cohort was divided into two groups according to the ablation energy source used : cryoballoon and RF ablation . MACCE was defined as a combination of death , myocardial infa rct ion , or stroke . RESULTS AF recurrence rate after a single ablation procedure at 1 year follow-up was not significantly different between the two groups ( 45.8 % after cryoablation and 45.4 % after RF ablation , P = .87 ) . Also , the rate of patients without AF recurrence and free of antiarrhythmic drug at 12-month follow-up was similar ( cryoablation 44.2 % and RF 41.4 % , P = .25 ) . MACCE occurred with an incidence of 0.7 % within 500 days after cryoablation and 1.4 % after RF ablation ( P = .30 ) . Persistent phrenic nerve palsy was more common after cryoablation compared to RF ablation ( 1.1 % vs. 0.3 % , P AF recurrence rate at 1-year follow-up was similar in RF ablation compared to cryoablation , whereas the spectrum and relevance of complications were significantly different between the two ablation methods . This finding might influence the choice of ablation method offered to the individual paroxysmal AF patient",
"OBJECTIVES This study sought to assess the safety and effectiveness of a novel cryoballoon ablation technology design ed to achieve single-delivery pulmonary vein ( PV ) isolation . BACKGROUND St and ard radiofrequency ablation is effective in eliminating atrial fibrillation ( AF ) but requires multiple lesion delivery at the risk of significant complications . METHODS Patients with documented symptomatic paroxysmal AF and previously failed therapy with ≥ 1 membrane active antiarrhythmic drug underwent 2:1 r and omization to either cryoballoon ablation ( n = 163 ) or drug therapy ( n = 82 ) . A 90-day blanking period allowed for optimization of antiarrhythmic drug therapy and reablation if necessary . Effectiveness of the cryoablation procedure versus drug therapy was determined at 12 months . RESULTS Patients had highly symptomatic AF ( 78 % paroxysmal , 22 % early persistent ) and experienced failure of at least one antiarrhythmic drug . Cryoablation produced acute isolation of three or more PVs in 98.2 % and all four PVs in 97.6 % of patients . PVs isolation was achieved with the balloon catheter alone in 83 % . At 12 months , treatment success was 69.9 % ( 114 of 163 ) of cryoblation patients compared with 7.3 % of antiarrhythmic drug patients ( absolute difference , 62.6 % [ p recurrent , symptomatic AF , constituting drug treatment failure . There were 7 of the result ing 228 cryoablated patients ( 3.1 % ) with a > 75 % reduction in PV area during 12 months of follow-up . Twenty-nine of 259 procedures ( 11.2 % ) were associated with phrenic nerve palsy as determined by radiographic screening ; 25 of these had resolved by 12 months . Cryoablation patients had significantly improved symptoms at 12 months . CONCLUSIONS The STOP AF trial demonstrated that cryoballoon ablation is a safe and effective alternative to antiarrhythmic medication for the treatment of patients with symptomatic paroxysmal AF , for whom at least one antiarrhythmic drug has failed , with risks within accepted st and ards for ablation therapy . ( A Clinical Study of the A rct ic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [ Stop AF ] ; NCT00523978 )",
"OBJECTIVES The purpose of this study was to investigate long-term outcomes of freedom from atrial fibrillation ( AF ) after pulmonary vein ( PV ) isolation using cryoballoon ablation with balloon-size selection based on individual PV diameters . BACKGROUND Data are lacking on long-term outcomes from cryoablation and on the most effective balloon size . METHODS This was a prospect i ve observational study involving 605 consecutively enrolled patients with symptomatic paroxysmal AF ( n = 579 ) or persistent AF . Cryoballoon size was based on magnetic resonance imaging and /or conventional angiograms . Patients were followed up every 3 months during the first year after discharge and every 6 months in the second year . After 24 months , follow-up was on an outpatient basis with documented AF episodes recorded . RESULTS The PV isolation was achieved without touch-up in 91.1 % of patients , using the smaller balloon in 26.7 % , the larger balloon in 25.6 % , and both balloons in 47.7 % of patients . Follow-up data for > 12 months ( median 30 months ; interquartile range 18 to 48 months ) were available for 451 patients , 278 ( 61.6 % ) of whom were free of AF recurrence with no need for repeat procedures after the 3-month blanking period . Rates of freedom from AF after 1 , 2 , and 3 repeat procedures ( using cryoballoon or radiofrequency ablation with similar success rates ) were 74.9 % , 76.2 % , and 76.9 % , respectively . Use of the smaller balloons or both balloons produced the highest rates of long-term freedom from AF . Phrenic nerve palsy occurred in 12 patients ( 2 % ) , resolving within 3 to 9 months . CONCLUSIONS Rates of long-term freedom from AF after cryoballoon ablation are similar to those reported for radiofrequency ablation . A choice between balloons may improve outcomes",
"Background — There is a lack of data on the comparative efficacy and procedural safety of open irrigated radiofrequency ( RF ) and cryoballoon catheter ( CB ) ablation for pulmonary vein isolation in patients with paroxysmal atrial fibrillation . Methods and Results — In a prospect i ve , noninferiority study , 315 patients were r and omly assigned to RF ( n=159 ) or CB ( n=156 ) ablation . The primary end point was freedom from atrial arrhythmia with absence of persistent complications . Patients were largely comparable between groups with more vascular disease in the RF group ( 8.2 % versus 2.6 % for CB ; P=0.028 ) . The primary end point at 12 months was achieved by 70.7 % with RF and 73.6 % with CB ( multiple procedure success ) , including 31 redo procedures in each group ( 19.5 % of RF versus 19.9 % of CB ; P=0.933 ) . For the intention-to-treat population , noninferiority of CB was revealed for the predefined inferiority margin ( risk difference , 0.029 ; 95 % confidence interval , −0.074 to 0.132 ; P Rates at 6 months were 63.1 % and 64.1 % for the RF and CB groups ( single procedure success ) , and noninferiority was confirmed ( risk difference , 0.010 ; 95 % confidence interval , −0.097 to 0.116 ; P=0.002 ) . Periprocedural complications for the index procedure were more frequent in the CB group ( 5.0 % RF , 12.2 % CB ; P=0.022 ) with a significant difference in phrenic nerve palsies ( 0 % RF , 5.8 % CB ; P=0.002 ) . Conclusion — This large , prospect i ve , r and omized , controlled study demonstrates noninferiority of CB ablation versus RF ablation for treating patients with paroxysmal atrial fibrillation . Clinical Trial Registration — URL : http://www . clinical trials.gov . Unique identifier : NCT00774566",
"AIMS The second-generation cryoballoon ( CB2 ) with increased surface cooling has recently become available . The aim was to investigate the incidence and characteristics of phrenic nerve palsy ( PNP ) during pulmonary vein isolation ( PVI ) using the CB2 as compared with the first-generation balloon ( CB1 ) . METHODS AND RESULTS A total of 360 consecutive patients with atrial fibrillation underwent PVI with the CB1 ( 106 patients ) or the CB2 ( 254 patients ) . Right PN function was monitored by continuous stimulation and palpation during septal PV ablation . Persistent PNP ( present at discharge ) occurred in 2.8 and 1.9 % ( P = 0.63 ) of patients , transient PNP ( full recovery before discharge ) in 5.9 and 3.8 % ( P = 0.41 ) of patients in the CB2 and CB1 group , respectively . Phrenic nerve palsy during ablation at the right inferior PV was observed in 0 % ( CB1 ) and 4.3 % ( CB2 , P = 0.03 ) of patients . Using the CB2 , a trend of reduced incidence of persistent PNP over quartiles of consecutive patients was observed [ 4.8 % ( Q1 ) vs. 0 % ( Q4 ) ; P = 0.077 ] . At the culprit PV , PNP occurred after 3.5 ± 2.1 ( CB1 ) and 1.1 ± 0.4 applications ( CB2 ; P = 0.036 ) . Complete recovery of PN function occurred after 29 ± 11 ( CB1 ) and 259 ± 137 days ( CB2 ; P = 0.004 ) . CONCLUSIONS The rate of transient/persistent PNP associated with the use of the CB2 was 5.9 and 2.8 % , respectively . Time to restitution of PN function was longer using the CB2 ",
"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 Catheter ablation is an established treatment for atrial fibrillation ( AF ) . Cryoballoon ablation ( CBA ) has emerged as an alternative to radiofrequency ablation ( RFA ) . However , there are few data comparing these modalities for treatment of paroxysmal AF ( pAF ) in the U.S. POPULATION The purpose of this study was to compare procedural times , safety , and efficacy of CBA against RFA . METHODS A single-center prospect i ve cohort study evaluated patients who underwent catheter ablation for pAF using CBA or RFA between January 1 , 2010 and October 31 , 2013 . Patients with prior ablation and those without rhythm follow-up for at least 3 months were excluded . The primary end point was freedom from AF , atrial flutter , and atrial tachycardia ( FFAF ) > 30 seconds after a 3-month blanking period without requirement for antiarrhythmic drugs . We also compared rates of successful pulmonary vein isolation ( PVI ) , fluoroscopy and procedure times , and major complication rates . RESULTS A total of 201 patients were included ( CBA = 101 , RFA = 100 ) . The rate of successful PVI was 99.3 % in CBA versus 97.4 % in RFA ( P = 0.08 ) . Procedure times were shorter with CBA ( 192.9 ± 44.0 minutes vs 283.7 ± 78.0 minutes , P total fluoroscopy times ( 46.0 ± 22.4 minutes vs 73.0 ± 30.1 minutes , P 0.001 ) . Overall complication rates were equivalent ; however , fewer cardiac perforations occurred with CBA ( 0 % vs 4 % , P = 0.042 ) . The 1-year FFAF rates were 60.3 % for CBA and 61.1 % for RFA ( log rank P = 0.93 ) . CONCLUSION CBA was associated with equivalent 1-year FFAF rate as RFA for pAF . Procedure and fluoroscopy times were shorter for CBA and fewer cardiac perforations occurred",
"Background . There are little comparative data on catheter ablation of paroxysmal atrial fibrillation ( AF ) using the contact force radiofrequency ( CF-RF ) catheter versus the second-generation cryoballoon ( CB2 ) . Methods and results . This is a single center , retrospective , nonr and omized study of 98 patients with symptomatic , drug-refractory paroxysmal AF who underwent their first PVI ablation using either the CB2 ( n = 40 ) or CF-RF ( n = 58 ) . The mean age was 60 years with 63 % men , a mean LA size of 42 mm . The procedure duration ( 74 ± 17 versus 120 ± 49 minutes p CB2 group ; the fluoroscopy time ( 14 ± 17 versus 16 ± 5 minutes , p = 0.45 ) was similar . Complete PVI was achieved in 96 % of patients with RF-CF and 98 % with CB2 . Phrenic nerve palsies ( 2 transient and 1 persistent ) occurred exclusively in the CB2 group and 1 severe , nonlethal complication ( pericardial tamponade ) occurred in the CF-RF group . At 24-month follow-up , the success rate , defined as freedom from AF/atrial tachycardia ( AT ) after a single procedure without antiarrhythmic drug , was comparable in CF-RF group and CB2 group ( 65.5 % versus 67 % , resp . , log rank p = 0.54 ) . Conclusion . Both the CB2 and the RF-CF ablation appeared safe ; the success rate at 2 years was comparable between both technologies",
"INTRODUCTION Catheter ablation of paroxysmal AF using the Cryoballoon ( CRYO ) has yielded similar success rates to conventional wide encirclement using radiofrequency catheter ablation ( RFCA ) , but r and omized data are lacking . Pilot data suggested a high success rate with a combined approach ( COMBINED ) using wide encirclement with RFCA followed by 2 CRYO applications to each vein . We compared these 3 strategies in a r and omized controlled trial . METHODS AND RESULTS Patients undergoing first time paroxysmal AF ablation were r and omized to RFCA , CRYO , or COMBINED . Patients were followed up at 3 , 6 , and 12 months with 7 days of ambulatory ECG monitoring . Success was defined as freedom from arrhythmia without antiarrhythmic drugs after a single procedure . A total of 237 patients were r and omized . Success at 1 year was achieved in 47 % in the RFCA group , 67 % in the CRYO group , and 76 % in the COMBINED group ( P RFCA vs. CRYO , P Procedure time was 211 ( IQR 174 - 256 ) minutes for RFCA compared to 167 ( 136 - 202 ) minutes for CRYO and 278 ( 243 - 327 ) minutes for COMBINED ( P CRYO and results in a higher single procedure success rate than conventional point by point RFCA . The COMBINED approach was not superior to CRYO alone",
"Background — Contact force ( CF ) is a major determinant of lesion size and transmurality and has the potential to improve efficacy of atrial fibrillation ablation . This study sought to evaluate the safety and effectiveness of a novel irrigated radiofrequency ablation catheter that measures real-time CF in the treatment of patients with paroxysmal atrial fibrillation . Methods and Results — A total of 300 patients with symptomatic , drug-refractory , paroxysmal atrial fibrillation were enrolled in a prospect i ve , multicenter , r and omized , controlled trial and r and omized to radiofrequency ablation with either a novel CF-sensing catheter or a non-CF catheter ( control ) . The primary effectiveness end point consisted of acute electrical isolation of all pulmonary veins and freedom from recurrent symptomatic atrial arrhythmia off all antiarrhythmic drugs at 12 months . The primary safety end point included device-related serious adverse events . End points were powered to show noninferiority . All pulmonary veins were isolated in both groups . Effectiveness was achieved in 67.8 % and 69.4 % of subjects in the CF and control arms , respectively ( absolute difference , −1.6 % ; lower limit of 1-sided 95 % confidence interval , −10.7 % ; P=0.0073 for noninferiority ) . When the CF arm was stratified into optimal CF ( ≥90 % ablations with ≥10 g ) and nonoptimal CF groups , effectiveness was achieved in 75.9 % versus 58.1 % , respectively ( P=0.018 ) . The primary safety end point occurred in 1.97 % and 1.40 % of CF patients and control subjects , respectively ( absolute difference , 0.57 % ; upper limit of 1-sided 95 % confidence interval , 3.61 % ; P=0.0004 for noninferiority ) . Conclusions — The CF ablation catheter met the primary safety and effectiveness end points . Additionally , optimal CF was associated with improved effectiveness . Clinical Trial Registration — http://www . clinical trials.gov . Unique identifier : NCT01278953",
"AIMS In the setting of paroxysmal atrial fibrillation ( AF ) , there are no available data comparing the mid-term outcome of patients undergoing pulmonary vein isolation ( PVI ) catheter ablation using contact-force (CF)-guided radiofrequency ( RF ) vs. second-generation balloon cryotherapy . METHODS AND RESULTS Prospect i ve single-centre evaluation , carried out from March 2011 to February 2013 , comparing CF radiofrequency ( Thermocool ( ® ) SmartTouch ™ , Biosense Webster , Inc. ) ( CF group ) with cryoballoon ablation ( A rct ic Front Advance ™ 28 mm cryoballoon , Medtronic , Inc. ) ( CB group ) , in regards to procedural safety and efficacy , as well as recurrence at 12 months . Overall , 150 consecutive patients were enrolled ( 75 in each group ) . The characteristics of patients of both the groups were similar ( 61.2 ± 9.9 years , women 25.3 % , mean AF duration 4.1 ± 4.0 years , mean CHA2DS2-VASc score 1.4 ± 1.3 , mean HAS-BLED 1.4 ± 0.6 ) . Duration of the procedure was significantly lower in the CF group ( 110.7 ± 32.5 vs. 134.5 ± 48.3 min , P = 0.001 ) , with a lower duration of fluoroscopy ( 21.5 ± 8.5 vs. 25.3 ± 9.9 min , P = 0.017 ) and X-ray exposure ( 4748 ± 2411 cGy cm² vs. 7734 ± 5361 cGy cm² , P = 0.001 ) . In contrast , no significant difference was found regarding significant procedural complication ( 2.7 vs. 1.3 % in CF and CB groups , respectively ; P = 0.56 ) , and PVI was eventually achieved in all cases . At 12 months , AF recurrence occurred in 11 patients ( 14.7 % ) in the CB group and in 9 patients ( 12.0 % ) in the CF group ( HR = 1.20 95 % CI 0.50 - 2.90 ; log rank P = 0.682 ) . CONCLUSIONS Our preliminary findings suggest that CF-guided radiofrequency and cryotherapy present very similar performances in the setting of paroxysmal AF catheter ablation",
"BACKGROUND Results from r and omized trials design ed to compare cryoenergy with radiofrequency for pulmonary vein ( PV ) isolation are lacking . OBJECTIVE To compare the efficacy of a simplified strategy for PV cryoablation ( group C ) vs PV isolation with open-irrigated radiofrequency catheters ( group R ) . METHODS Fifty patients with paroxysmal atrial fibrillation ( AF ) and 4 independent PVs received a Reveal XT implantable cardiac monitor and were r and omized to group C or group R. In group C , PV ablation was done with a single A rct ic Front balloon ( 23 or 28 mm ) per patient and two 300-second applications per PV . No further applications were delivered to close residual conduction gaps . In group R , bidirectional PV conduction block was pursued with Lasso and Navistar ThermoCool catheters and the CARTO system . The primary end point was the proportion of patients remaining free from AF recurrences ≥2 minutes without taking antiarrhythmic drugs 12 months after ablation . RESULTS The primary end point was met by 12 ( 48 % ) patients in group C and 25 ( 68 % ) patients in group R ( odds ratio 0.43 ; P = .05 ) . This difference disappeared after adjustment for acute procedural outcome . In patients for whom all 4 PVs were blocked at the end of the procedure , there was no difference between group C and group R in the primary end point ( 67 % vs 68 % ; P = .94 ) . CONCLUSIONS The efficacy of the simplified strategy for PV cryoablation tested in this study is inferior to PV isolation using open-irrigated radiofrequency catheters with electrophysiological and electroanatomical guidance . Complete PV conduction block is critical to the success of AF ablation",
"Aim Cryoballoon ablation ( Cryoballoon ) has emerged as a new alternative for the treatment of symptomatic drug-refractory atrial fibrillation ( AF ) . Whether the results of Cryoballoon are more reproducible than those of radiofrequency ( RF ) ablation remains to be proved . Methods and results A total of 860 consecutive patients undergoing a first ablation procedure for paroxysmal AF ( 467 treated with RF and 393 treated with Cryoballoon ) were selected from a prospect i ve multicentre survey of AF ablation ( FrenchAF ) . Radiofrequency and Cryoballoon were compared regarding mid-term efficacy and safety . During a median follow-up of 14 months ( interquartile range 8–23 ) , patients treated with Cryoballoon displayed similar rates of freedom from atrial arrhythmia relapse in centres performing this technique ( 68–80 % at 18 months ) . However , in centres performing RF , a greater heterogeneity in procedural results was observed ( 46–79 % were free from atrial arrhythmia relapse at 18 months ) . On multivariate analysis , Cryoballoon ( HR = 0.47 , 95 % CI 0.35–0.65 , P AF ablation caseload ( HR = 0.87 per every 100 AF ablation procedures per year ; 95 % CI 0.80–0.96 , P = 0.003 ) were independent predictors of procedural success . However , on sensitivity analysis , according to the ablation method , annual AF ablation caseload predicted only sinus rhythm maintenance in the subgroup of patients treated with RF . Analysis of interoperator results with Cryoballoon and RF confirmed lower reproducibility of RF , but suggested that besides caseload , other operator-related factors may play a role . Conclusion Cryoballoon seems to be less operator-dependent and more reproducible than RF in the setting of paroxysmal AF ablation",
"BACKGROUND Current guidelines recommend pulmonary-vein isolation by means of catheter ablation as treatment for drug-refractory paroxysmal atrial fibrillation . Radiofrequency ablation is the most common method , and cryoballoon ablation is the second most frequently used technology . METHODS We conducted a multicenter , r and omized trial to determine whether cryoballoon ablation was noninferior to radiofrequency ablation in symptomatic patients with drug-refractory paroxysmal atrial fibrillation . The primary efficacy end point in a time-to-event analysis was the first documented clinical failure ( recurrence of atrial fibrillation , occurrence of atrial flutter or atrial tachycardia , use of antiarrhythmic drugs , or repeat ablation ) following a 90-day period after the index ablation . The noninferiority margin was prespecified as a hazard ratio of 1.43 . The primary safety end point was a composite of death , cerebrovascular events , or serious treatment-related adverse events . RESULTS A total of 762 patients underwent r and omization ( 378 assigned to cryoballoon ablation and 384 assigned to radiofrequency ablation ) . The mean duration of follow-up was 1.5 years . The primary efficacy end point occurred in 138 patients in the cryoballoon group and in 143 in the radiofrequency group ( 1-year Kaplan-Meier event rate estimates , 34.6 % and 35.9 % , respectively ; hazard ratio , 0.96 ; 95 % confidence interval [ CI ] , 0.76 to 1.22 ; P primary safety end point occurred in 40 patients in the cryoballoon group and in 51 patients in the radiofrequency group ( 1-year Kaplan-Meier event rate estimates , 10.2 % and 12.8 % , respectively ; hazard ratio , 0.78 ; 95 % CI , 0.52 to 1.18 ; P=0.24 ) . CONCLUSIONS In this r and omized trial , cryoballoon ablation was noninferior to radiofrequency ablation with respect to efficacy for the treatment of patients with drug-refractory paroxysmal atrial fibrillation , and there was no significant difference between the two methods with regard to overall safety . ( Funded by Medtronic ; FIRE AND ICE Clinical Trials.gov number , NCT01490814 . )",
"OBJECTIVES The purpose of this study was to investigate the efficacy safety of the novel cryoballoon device ( A rct ic Front , Cryocath , Quebec , Canada ) . BACKGROUND Antral pulmonary vein ( PV ) ablation with radiofrequency energy is widely used as a strategy for catheter ablation of paroxysmal atrial fibrillation ( PAF ) . A novel double lumen cryoballoon catheter was design ed for circumferential pulmonary vein isolation ( PVI ) with the cryoablation technique . METHODS We consecutively enrolled 346 patients with symptomatic , drug refractory paroxysmal ( n = 293 ) or persistent ( n = 53 ) atrial fibrillation ( AF ) . In all patients , PVI of all targeted PVs was the therapeutic aim . The primary end points of this nonr and omized study were : 1 ) acute isolation rate of targeted PV ; and 2 ) first electrocardiogram-documented recurrence of AF . The secondary end point was occurrence of PV stenosis or atrio-esophageal fistula . RESULTS The 1,360 of 1,403 PVs ( 97 % ) were targeted with balloons or balloons in combination with the use of Freezor Max ( Cryocath ) . We found that ablation with the cryoballoon result ed in maintenance of sinus rhythm in 74 % of patients with PAF and 42 % of patients with persistent AF . No PV narrowing occurred . The most frequent complication was right phrenic nerve palsy observed during cryoballoon ablation at the right superior PV . CONCLUSIONS Pulmonary vein isolation with a new cryoballoon technique is feasible . Sinus rhythm can be maintained in the majority of patients with PAF by circumferential PVI using a cryoballoon ablation system . Cryoablation was less effective in patients with persistent AF than in patients with PAF"
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41172b02-06ff-11f0-808a-c43d1ab1c353
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This review aims to assess by meta- analysis of r and omised controlled trials ( RCTs ) changes in pain and function when overweight patients with knee osteoarthritis ( OA ) achieve a weight loss . Systematic search es were performed and reference lists from the retrieved trials were search ed . RCTs were enclosed in the systematic review if they explicitly stated diagnosis of knee OA and reported a weight change as the only difference in intervention from the control group . Outcome Measures for Arthritis Clinical Trials III outcome variables were considered for analysis . Effect size ( ES ) was calculated using RevMan , and meta-regression analyses were performed using weighted estimates from the r and om effects analyses . Among 35 potential trials identified , four RCTs including five intervention/control groups met our inclusion criteria and provided data from 454 patients . Pooled ES for pain and physical disability were 0.20 ( 95 % CI 0 to 0.39 ) and 0.23 ( 0.04 to 0.42 ) at a weight reduction of 6.1 kg ( 4.7 to 7.6 kg ) . Meta-regression analysis showed that disability could be significantly improved when weight was reduced over 5.1 % , or at the rate of > 0.24 % reduction per week . Clinical efficacy on pain reduction was present , although not predictable after weight loss . Meta-regression analysis indicated that physical disability of patients with knee OA and overweight diminished after a moderate weight reduction regime . The analysis supported that a weight loss of > 5 % should be achieved within a 20-week period -- that is , 0.25 % per week
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"OBJECTIVE To evaluate the effect of weight reduction on the rehabilitation of patients with knee osteoarthritis and obesity . METHODS A total of 126 patients with bilateral knee osteoarthritis and obesity were classified into 3 groups by their stages of osteoarthritis . Each group was divided into subgroups a , b , and c. The subjects in subgroup a received weight reduction treatment , those in subgroup b received weight reduction and electrotherapy modalities , and those in subgroup c received electrotherapy modalities to relieve pain . RESULTS Pain reduction , weight reduction , ambulation speed , and changes of Lequesne 's index were greater in patients in subgroups a and b than in subgroup c after treatment . Although the last pain scores in subgroup b were less than those in subgroup a , as measured by a visual analog scale ( VAS ) , there was no significant difference between their functional status . Significant pain relief ( VAS acceptable functional status ( Lequesne 's index < 7 ) were indicated when weight reduction was more than 15 % and 12 % , respectively , of the initial body weight of the individual . CONCLUSION Weight reduction was found to be a practical adjuvant treatment in the rehabilitation of patients with knee osteoarthritis",
"This study examined the effects of dietary weight loss and exercise on the health-related quality of life ( HRQL ) of overweight and obese , older adults with knee osteoarthritis . A total of 316 older men and women with documented evidence of knee osteoarthritis were r and omly assigned to 1 of 4 18-month interventions : dietary weight loss , exercise , dietary weight loss and exercise , or healthy lifestyle control . Measures included the SF-36 Health Survey and satisfaction with body function and appearance . Results revealed that the combined diet and exercise intervention had the most consistent , positive effect on HRQL compared with the control group ; however , findings were restricted to measures of physical health or psychological outcomes that are related to the physical self",
"Practice guidelines are valid if “ they lead to the health gains and costs predicted for them.”1 When implemented , valid guidelines lead to changes in clinical practice and improvements in outcomes for patients .2 - 5 Invalid guidelines , however , may lead to the use of ineffective interventions that waste re sources , or even to harm . Guidelines must offer recommendations for both effective and efficient care , and these have not previously been available in the United Kingdom . We have reported the development and content of guidelines for primary care in the United Kingdom based explicitly on evidence of effectiveness.6 - 9 Here , we present the methods used to develop evidence based guidelines on the use in primary care of four important groups of drugs — angiotensin converting enzyme inhibitors in patients with heart failure , choice of antidepressants , non-steroidal anti-inflammatory drugs in patients with osteoarthritis , and aspirin as an antithrombotic agent.10 - 13 Abridged versions of the guidelines on angiotensin converting enzyme inhibitors , aspirin , and non-steroidal anti-inflammatory drugs will be published in subsequent articles.14 - 16 # # # # Summary points Guideline development groups defined important clinical questions , produced search criteria , and drew up protocol s for systematic review and , where appropriate , meta- analysis Medline and Embase were search ed for systematic review s and meta-analyses , r and omised trials , quality of life studies , and economic studies Meta- analysis was used extensively by the group to answer specific clinical questions Statements on evidence were categorised in relation to study design , reflecting their susceptibility to bias Strength of recommendations was grade d according to the category of evidence and its applicability , economic issues , values of the guideline group and society , and the groups ' awareness of practical issues Recommendations cease to apply in December 1999 , by which time relevant results that may affect recommendations may be known Guideline development groups comprised three broad classes of members — relevant healthcare professionals ( up to five general practitioners ( all with",
"OBJECTIVE To determine whether high exercise adherence improved physical function among older adults with knee osteoarthritis ( OA ) who were overweight or obese . METHODS Associations between exercise adherence , changes in 6-minute walking distance in meters , and self-reported disability ( Western Ontario and McMaster Universities Osteoarthritis Index function subscale ) after 6 and 18 months were examined among an Arthritis , Diet , and Activity Promotion Trial sub sample ( n = 134 ) using multiple linear regression models . RESULTS Higher exercise adherence was associated with greater improvements in 6-minute walking distance after 6 and 18 months and in disability after 6 months . Pain and body mass index ( BMI ) contributed , to some extent , to explaining the link between exercise adherence and changes in physical performance and self-reported disability . CONCLUSION Higher exercise adherence is associated with improved physical function in overweight and obese older adults with knee OA . This indicates that promoting adherence is clinical ly relevant when prescribing exercise regimens that also focus on decreasing pain and BMI",
"BACKGROUND Persistent , low- grade inflammation is an independent predictor of several chronic diseases and all-cause mortality . OBJECTIVE The intention of this study was to determine the independent and combined effects of diet-induced weight loss and exercise on markers of chronic inflammation . DESIGN Three hundred sixteen community-dwelling , older ( > or = 60 y ) , overweight or obese [ body mass index ( in kg/m2 ) > or = 28 ] , sedentary men and women with radiographic evidence of knee osteoarthritis were r and omly assigned to four 18-mo treatments : healthy lifestyle control , diet-induced weight loss , exercise , and diet plus exercise . The exercise intervention consisted of combined weight training and walking for 1 h 3 times/wk . The weight-loss intervention consisted of a weekly session with a registered dietitian to provide education and support for lowering energy intake . RESULTS The diet-induced weight-loss intervention result ed in significantly greater reductions in concentrations of C-reactive protein ( P = 0.01 ) , interleukin 6 ( P = 0.009 ) , and soluble tumor necrosis factor alpha receptor 1 ( P = 0.007 ) than did no weight-loss treatment . Changes in soluble tumor necrosis factor alpha receptor 1 but not in C-reactive protein or interleukin 6 correlated with changes in body weight . Exercise training did not have a significant effect on these inflammatory biomarkers , and there was no significant interaction between weight loss and exercise training . CONCLUSIONS These findings provide evidence from a r and omized controlled trial that a dietary intervention design ed to elicit weight loss reduces overall inflammation in older , obese persons . Additional studies are needed to assess the effects of different modes and intensities of exercise on inflammation",
"OBJECTIVE The Arthritis , Diet , and Activity Promotion Trial ( ADAPT ) was a r and omized , single-blind clinical trial lasting 18 months that was design ed to determine whether long-term exercise and dietary weight loss are more effective , either separately or in combination , than usual care in improving physical function , pain , and mobility in older overweight and obese adults with knee osteoarthritis ( OA ) . METHODS Three hundred sixteen community-dwelling overweight and obese adults ages 60 years and older , with a body mass index of > or = 28 kg/m(2 ) , knee pain , radiographic evidence of knee OA , and self-reported physical disability , were r and omized into healthy lifestyle ( control ) , diet only , exercise only , and diet plus exercise groups . The primary outcome was self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Secondary outcomes included weight loss , 6-minute walk distance , stair-climb time , WOMAC pain and stiffness scores , and joint space width . RESULTS Of the 316 r and omized participants , 252 ( 80 % ) completed the study . Adherence was as follows : for healthy lifestyle , 73 % ; for diet only , 72 % ; for exercise only , 60 % ; and for diet plus exercise , 64 % . In the diet plus exercise group , significant improvements in self-reported physical function ( P 6-minute walk distance ( P stair-climb time ( P knee pain ( P 6-minute walk distance ( P . The weight-loss groups lost significantly ( P body weight ( for diet , 4.9 % ; for diet plus exercise , 5.7 % ) than did the healthy lifestyle group ( 1.2 % ) . Finally , changes in joint space width were not different between the groups . CONCLUSION The combination of modest weight loss plus moderate exercise provides better overall improvements in self-reported measures of function and pain and in performance measures of mobility in older overweight and obese adults with knee OA compared with either intervention alone",
"Background Studies on exercise in knee osteoarthritis ( OA ) have focused on elderly subjects . Subjects in this study were middle-aged with symptomatic and definite radiographic knee osteoarthritis . The aim was to test the effects of a short-term , high-intensity exercise program on self-reported pain , function and quality of life . Methods Patients aged 36–65 , with OA grade III ( Kellgren & Lawrence ) were recruited . They had been referred for radiographic examination due to knee pain and had no history of major knee injury . They were r and omized to a twice weekly supervised one hour exercise intervention for six weeks , or to a non-intervention control group . Exercise was performed at ≥ 60 % of maximum heart rate ( HR max ) . The primary outcome measure was the Knee injury and Osteoarthritis Outcome Score ( KOOS ) . Follow-up occurred at 6 weeks and 6 months . Results Sixty-one subjects ( mean age 56 ( SD 6 ) , 51 % women , mean BMI 29.5 ( SD 4.8 ) ) were r and omly assigned to intervention ( n = 30 ) or control group ( n = 31 ) . No significant differences in the KOOS subscales assessing pain , other symptoms , or function in daily life or in sport and recreation were seen at any time point between exercisers and controls . In the exercise group , an improvement was seen at 6 weeks in the KOOS subscale quality of life compared to the control group ( mean change 4.0 vs. -0.7 , p = 0.05 ) . The difference between groups was still persistent at 6 months ( p = 0.02 ) . Conclusion A six-week high-intensive exercise program had no effect on pain or function in middle-aged patients with moderate to severe radiographic knee OA . Some effect was seen on quality of life in the exercise group compared to the control group",
"OBJECTIVE : To determine the effect of weight loss and exercise interventions on serum leptin and to investigate the relationship of physical function and osteoarthritis ( OA ) severity with serum leptin in older overweight and obese adults with knee OA . In addition , the study examined if serum leptin predicts weight loss . DESIGN : Longitudinal , controlled clinical trial of weight loss and exercise interventions .SUBJECTS : Community dwelling , older , overweight and obese adults ( n=316 ; > 60 years of age ; body mass index ≥28.0 kg m−2 ) with symptomatic knee OA and self-reported difficulty in performing selected physical activities were recruited . INTERVENTIONS : Participants were r and omized into one of four groups for the 18-month study duration : Healthy Lifestyle Controls , Dietary Weight Loss ( Diet ) , Exercise Training ( Exercise ) , and a combination of Dietary Weight Loss and Exercise Training ( Diet+Exercise ) . The weight loss goal for the two Diet groups was 5 % from baseline at 18 months . Participants in the Exercise groups were trained for 3 days week−1 , 60 min day−1 . MEASUREMENTS : Body weight , body mass index , serum leptin , physical function , and OA severity were measured at baseline , 6 months , and 18 months . RESULTS : Diet and Diet+Exercise groups lost 5.3 and 6.1 % of their weight , respectively , at 18 months with the Exercise group losing 2.9 % . There was a significant main effect of weight loss on serum leptin with a decrease in serum leptin averaged across the 6- and 18-month time points for the Diet and Diet+Exercise groups compared to the other two groups ( β=0.245 ; P for exercise training was observed . Serum leptin was related to self-reported physical function . In all participants , a mixed model analysis demonstrated that lower levels of baseline serum leptin predict larger weight loss ( β=−2.779 ; P=0.048 ) . CONCLUSION : Decreases in serum leptin may be one mechanism by which weight loss improves physical function and symptoms in OA patients",
"OBJECTIVE To determine whether a multimodal physiotherapy programme including taping , exercises , and massage is effective for knee osteoarthritis , and if benefits can be maintained with self management . METHODS R and omised , double blind , placebo controlled trial ; 140 community volunteers with knee osteoarthritis participated and 119 completed the trial . Physiotherapy and placebo interventions were applied by 10 physiotherapists in private practice s for 12 weeks . Physiotherapy included exercise , massage , taping , and mobilisation , followed by 12 weeks of self management . Placebo was sham ultrasound and light application of a non-therapeutic gel , followed by no treatment . Primary outcomes were pain measured by visual analogue scale and patient global change . Secondary measures included WOMAC , knee pain scale , SF-36 , assessment of quality of life index , quadriceps strength , and balance test . RESULTS Using an intention to treat analysis , physiotherapy and placebo groups showed similar pain reductions at 12 weeks : -2.2 cm ( 95 % CI , -2.6 to -1.7 ) and -2.0 cm ( -2.5 to -1.5 ) , respectively . At 24 weeks , pain remained reduced from baseline in both groups : -2.1 ( -2.6 to -1.6 ) and -1.6 ( -2.2 to -1.0 ) , respectively . Global improvement was reported by 70 % of physiotherapy participants ( 51/73 ) at 12 weeks and by 59 % ( 43/73 ) at 24 weeks . Similarly , global improvement was reported by 72 % of placebo participants ( 48/67 ) at 12 weeks and by 49 % ( 33/67 ) at 24 weeks ( all p>0.05 ) . CONCLUSIONS The physiotherapy programme tested in this trial was no more effective than regular contact with a therapist at reducing pain and disability",
"The objective of this study was to determine whether the Arthritis Self-Management Programme ( ASMP ) improves perceptions of control , health behaviours and health status , and changes use of health care re sources . The design was a pragmatic r and omized controlled study ; participants were allocated to ASMP ( Intervention Group ) or a 4-month waiting-list Control Group . The Intervention Group completed a 12-month follow-up . In total , 544 people with arthritis were recruited from the community--311 in the Intervention Group and 233 in the Control Group . Main outcome measures included : arthritis self-efficacy , health behaviours ( exercise , cognitive symptom management , diet and relaxation ) and health status ( pain , fatigue , anxiety , depression and positive affect ) . At 4 months follow-up , the ASMP had a significant effect on arthritis self-efficacy for other symptoms and pain subscales . Performance of a range of health behaviours ( cognitive symptom management , communication with physicians , dietary habit , exercise and relaxation ) was significantly greater among the Intervention Group . The Intervention Group were significantly less depressed and had greater positive mood . In addition , trends towards decreases on fatigue and anxiety were noted . Physical functioning , pain and GP visits remained stable at 4 months . A similar pattern of findings was found at 12 months follow-up for the Intervention Group . Furthermore , a significant improvement was found on pain and visits to GPs had decreased . Apart from a small improvement on physical functioning among the Intervention Group participants with osteoarthritis 12 months , all effects were independent of the type of arthritis . The findings suggest that the ASMP is effective in promoting improvements in perception of control , health behaviours and health status , when delivered in UK setting ",
"Background : The causal relationship between obesity and osteoarthritis ( OA ) of the knee is generally accepted . Weight loss has been shown to reduce the development of OA and improve the radiological parameters of existing disease . However , inducing weight reduction is difficult , and thus the number of patients studied has been small . We wished to determine the effects of surgically-induced weight loss on objective , radiological evidence of OA in the knee joint . Methods : 64 consecutive patients that were referred to the Bariatric Surgical Unit were enrolled in the study . The only exclusion criterion was the prior diagnosis of OA . Knee pain alone did not exclude patients from the study . The study was performed in a prospect i ve manner as a before-after trial . Radiographic data was evaluated by an independent radiologist not involved in the patient care or follow-up . Upright film of the knee was taken prior to surgery and 3 months following surgery . Minimal medial joint space width ( JSW ) was measured by a digital image computer . In addition , patients were clinical ly assessed using the American Knee Society Score ( AKSS ) at these times . Results : 59 of 64 patients were available for followup . BMI decreased from 43.4 to 36.9 ( P medial joint space increased from 4.6 mm to 5.25 mm ( P AKSS improved from 78.5 points ( perfect function = 100 points ) to 90.69 points ( P Surgically-induced weight loss is an effective , rapid and dependable means of reversing the radiological signs of early changes associated with OA",
"OBJECTIVE The purpose s of this pilot study were to determine if a combined dietary and exercise intervention would result in significant weight loss in older obese adults with knee osteoarthritis , and to compare the effects of exercise plus dietary therapy with exercise alone on gait , strength , knee pain , biomarkers of cartilage degradation , and physical function . DESIGN Single-blind , two-arm , r and omized clinical trial conducted for 24 weeks . SETTING A university health and exercise science center . PARTICIPANTS Twenty-four community-dwelling obese older adults aged > or = 60 years , body mass index > or = 28 , knee pain , radiographic evidence of knee osteoarthritis , and self-reported physical disability . INTERVENTION R and omization into two groups : exercise and diet ( E&D ) and exercise alone ( E ) . Exercise consisted of a combined weight training and walking program for 1 hour three times per week . The dietary intervention included weekly sessions with a nutritionist utilizing cognitive-behavior modification to change dietary habits to reach a group goal of an average weight loss of 15 lb ( 6.8 kg ) over 6 months . MEASUREMENTS All measurements were conducted at baseline and 3 and 6 months , except for synovial fluid analysis , which was obtained only at baseline and 6 months . In addition , weight was measured weekly in the E&D group . Physical disability and knee pain were measured by self-report and physical performance was measured using the 6-minute walk and stair climb tasks . Biomechanical testing included kinetic and kinematic analysis of gait and isokinetic strength testing . Synovial fluid was analyzed for levels of total proteoglycan , keratan sulfate , and interleukin-1 beta . RESULTS Twenty-one of the 24 participants completed the study , with one dropout in the E&D group and two in the E group . The E&D group lost a mean of 18.8 lb ( 8.5 kg ) at 6 months compared with 4.0 lb ( 1.8 kg ) in the E group ( P = .01 ) . Significant improvements were noted in both groups in self-reported disability and knee pain intensity and frequency as well as in physical performance measures . However , no statistical differences were found between the two groups at 6 months in knee pain scores or self-reported performance measures of physical function . There was no difference in knee strength between the groups , with both groups showing modest improvements from baseline to 6 months . At 6 months , the E&D group had a significantly greater loading rate ( P = .03 ) and maximum braking force ( P = .01 ) during gait . There were no significant between-group differences in the other biomechanical measures . Synovial fluid sample s were obtainable at both baseline and 6 months in eight participants ( four per group ) . The level of keratan sulfate decreased similarly in both groups from an average baseline of 96.8 + /- 37.1 to 71.5 + /- 23 ng/microg total proteoglycan . The level of IL-1 decreased from 25.3 + /- 9.8 at baseline to 8.3 + /- 6.1 pg/mL. The decrease in IL-1 correlated with the change in pain frequency ( r = -0.77 , P = .043 ) . CONCLUSIONS Weight loss can be achieved and sustained over a 6-month period in a cohort of older obese persons with osteoarthritis of the knee through a dietary and exercise intervention . Both exercise and combined weight loss and exercise regimens lead to improvements in pain , disability , and performance . Moreover , the trends in the biomechanical data suggest that exercise combined with diet may have an additional benefit in improved gait compared with exercise alone . A larger study is indicated to determine if weight loss provides additional benefits to exercise alone in this patient population",
"OBJECTIVE To examine changes in mobility-related self efficacy following exercise and dietary weight loss interventions in overweight and obese older adults with knee osteoarthritis ( OA ) , and to determine if self efficacy and pain mediate the effects of the interventions on mobility task performance . METHODS The Arthritis , Diet , and Activity Promotion Trial was an 18-month , single-blind , r and omized , controlled trial comparing the effects of exercise alone , dietary weight loss alone , a combination of exercise plus dietary weight loss , and a healthy lifestyle control intervention in the treatment of 316 overweight or obese older adults with symptomatic knee OA . Participants completed measures of stair-climb time and 6-minute walk distance , self efficacy for completing each mobility task , and self-reported pain at baseline , 6 months , and 18 months during the trial . RESULTS Mixed model analyses of covariance of baseline adjusted change in the outcomes demonstrated that the exercise + dietary weight loss intervention produced greater improvements in mobility-related self efficacy ( P = 0.0035 ) , stair climb ( P = 0.0249 ) and 6-minute walk performance ( P = 0.00031 ) , and pain ( P = 0.09 ) when compared with the healthy lifestyle control intervention . Mediation analyses revealed that self efficacy and pain served as partial mediators of the beneficial effect of exercise + dietary weight loss on stair-climb time . CONCLUSION Exercise + dietary weight loss results in improved mobility-related self efficacy ; changes in these task-specific control beliefs and self-reported pain serve as independent partial mediators of the beneficial effect of exercise + dietary weight loss on stair-climb performance",
"OBJECTIVE To determine the relationship between change in body mass and knee-joint moments and forces during walking in overweight and obese older adults with knee osteoarthritis ( OA ) following an 18-month clinical trial of diet and exercise . METHODS Data were obtained from 142 sedentary , overweight , and obese older adults with self-reported disability and radiographic evidence of knee OA who underwent 3-dimensional gait analysis . Gait kinetic outcome variables included peak knee-joint forces and peak internal knee-joint moments . Mixed regression models were created to predict followup kinetic values , using followup body mass as the primary explanatory variable . Baseline body mass was used as a covariate , and thus followup body mass was a surrogate measure for change in body mass ( i.e. , weight loss ) . RESULTS There was a significant direct association between followup body mass and peak followup values of compressive force ( P = 0.001 ) , result ant force ( P = 0.002 ) , abduction moment ( P = 0.03 ) , and medial rotation moment ( P = 0.02 ) . A weight reduction of 9.8 N ( 1 kg ) was associated with reductions of 40.6 N and 38.7 N in compressive and result ant forces , respectively . Thus , each weight-loss unit was associated with an approximately 4-unit reduction in knee-joint forces . In addition , a reduction in body weight of 9.8 N ( 1 kg ) was associated with a 1.4 % reduction ( 0.496 Nm ) in knee abduction moment . CONCLUSION Our results indicate that each pound of weight lost will result in a 4-fold reduction in the load exerted on the knee per step during daily activities . Accumulated over thous and s of steps per day , a reduction of this magnitude would appear to be clinical ly meaningful",
"OBJECTIVE We wanted to assess the effect of rapid diet-induced weight loss on the function of obese , knee osteoarthritis ( OA ) patients . METHODS Eighty patients with knee OA , 89 % women ( n=71 ) , were recruited . Mean ( SD ) body-mass index ( BMI ) was 35.9 ( 5.1 ) kg/m(2 ) and age 62.6 ( 11.1 ) years . Patients were r and omized to either a low-energy diet ( LED 3.4MJ/day ) , or a control diet ( 5MJ/day ) . The LED group had weekly dietary sessions , whereas the control group was given a booklet describing weight loss practice s. Changes in body weight and body composition were examined as independent predictors of changes in knee OA symptoms . Symptoms were monitored by the Western Ontario and McMaster Universities ' ( WOMAC ) OA index . RESULTS The LED and control group lost a mean ( SE ) of 11.1 (0.6)% and 4.3 (0.6)% , respectively , with a mean difference being 6.8 % ( 95 % confidence interval ( CI ) : 5.5 to 8.1 % ; P decrease in body fat percent was higher in the LED group , 2.2 % ( 1.5 to 3.0 % ; P total WOMAC index improved in the LED group ( P ' Number Needed to Treat ( NNT ) ' to ensure an improvement in WOMAC>/=50 % was 3.4 ( 2.1 to 8.8 ) patients . Changes in total WOMAC index were best predicted by the reduction of body fat percent , with a 9.4 % ( 4.8 to 13.9 % ) improvement in WOMAC for each percent of body fat reduced ( P=0.0005 ) . CONCLUSIONS In our patients with knee OA , a weight reduction of 10 % improved function by 28 % . LED might be of advantage to control diet because of the rapidity of weight loss and a more significant loss of body fat",
"BACKGROUND Obesity exacerbates the age-related decline in physical function and causes frailty in older persons . However , appropriate treatment for obese older persons is unknown . We evaluated the effects of weight loss and exercise therapy on physical function and body composition in obese older persons . METHODS We screened 40 obese older volunteers and eventually r and omized 27 frail obese older volunteers to treatment or control groups . Treatment consisted of 6 months of weekly behavioral therapy for weight loss in conjunction with exercise training 3 times per week . Physical function was evaluated with measurements of frailty ( Physical Performance Test , peak oxygen consumption , and Functional Status Question naire ) ; strength , gait , and balance tests ; body composition with dual-energy x-ray absorptiometry ; and quality of life using the Medical Outcomes Survey 36-Item Short-Form Health Survey . Results are reported as mean + /- SD . RESULTS Two subjects in the treatment group did not comply with the intervention , and 1 subject in the control group withdrew . Analyses included all 27 subjects originally r and omized to the treatment and control groups . The treatment group lost 8.4 % + /- 5.6 % of body weight , whereas weight did not change in the control group ( + 0.5 % + /- 2.8 % ; P fat mass decreased ( -6.6 + /- 3.4 vs + 1.7 + /- 4.1 kg ; P fat-free mass ( -1.2 + /- 2.1 vs -1.0 + /- 3.5 kg ; P = .75 ) in the treatment group . The Physical Performance Test score ( 2.6 + /- 2.5 vs 0.1 + /- 1.0 ; P = .001 ) , peak oxygen consumption ( 1.7 + /- 1.6 vs 0.3 + /- 1.1 mL/min per kilogram ; P = .02 ) , and Functional Status Question naire score ( 2.9 + /- 3.7 vs -0.2 + /- 3.9 ; P = .02 ) improved in treated subjects compared with control subjects . Treatment also improved strength , walking speed , obstacle course , 1-leg limb stance time , and health survey physical subscale scores ( all P in obese older adults . Trial Registration clinical trials.gov Identifier : NCT00146133",
"BACKGROUND Determinants of adherence to lifestyle regimens are ill understood . Attendance to intervention sessions is crucial for patients to acquire knowledge and skills regarding the core elements of an intervention . Therefore , we explored demographic , health-related , and social determinants of high and low attendance to diet and exercise sessions among overweight and obese patients with knee osteoarthritis ( > or = 60 years ; N = 206 ) . METHODS The Arthritis , Diet , and Activity Promotion Trial was an 18-month r and omized controlled trial on the effectiveness of dietary weight loss and exercise interventions . We conducted chi-square and t-tests , and logistic regression analyses on categories of short- and long-term attendance to intervention sessions . RESULTS Over the 18-month duration of the study , 60.7 % ( + /- 28.5 ) of diet sessions , and 53.2 % ( + /- 29.0 ) of exercise sessions were attended . Not being married , low social participation , and single intervention r and omization predicted high attendance to diet sessions during months 1 - 4 . Exercising at home , and single intervention r and omization predicted high attendance to exercise sessions during months 5 - 18 . High attendance to sessions early in the intervention was a significant determinant of high session attendance thereafter . CONCLUSIONS Offering people a choice where to exercise , and stimulating early intervention session attendance can be effective in improving long-term attendance to both interventions . Several determinants we found may be amenable to change to enhance intervention adherence of future r and omized controlled trials involving dietary weight loss and /or physical exercise",
"Osteoarthritis ( OA ) of the knee leads to restrictions of physical activity and ability to perform activities of daily living . Obesity is a risk factor for knee OA and it appears to exacerbate knee pain and disability . The Arthritis , Diet , and Activity Promotion Trial ( ADAPT ) was developed to test the efficacy of lifestyle behavioral changes on physical function , pain , and disability in obese , sedentary older adults with knee OA . This controlled trial r and omized 316 sedentary overweight and obese older adults in a two-by-two factorial design into one of four 18-month duration intervention groups : Healthy Lifestyle Control ; Dietary Weight Loss ; Structured Exercise ; or Combined Exercise and Dietary Weight Loss . The weight-loss goal for the diet groups was a 5 % loss at 18 months . The intervention was modeled from principles derived from the group dynamics literature and social cognitive theory . Exercise training consisted of aerobic and strength training for 60 minutes , three times per week in a group and home-based setting . The primary outcome measure was self-report of physical function using the Western Ontario and McMaster University Osteoarthritis Index . Other measurements included timed stair climb , distance walked in 6 minutes , strength , gait , knee pain , health-related quality of life , knee radiographs , body weight , dietary intake , and cost-effectiveness of the interventions . We report baseline data stratified by level of overweight and obesity focusing on self-reported physical function and physical performance tasks . The results from ADAPT will provide approaches clinicians should recommend for behavioral therapies that effectively reduce the incidence of disability associated with knee OA",
"Abstract Two hundred and twenty-eight Japanese women , aged 45–69 years , with osteoarthritis of the knee ( knee OA ) and a body mass index of greater than 26.4 self-selected one of the following interventions : ( 1 ) a nonsteroidal anti-inflammatory drug ( NSAID ) alone ( NA group ; n = 52 ) , ( 2 ) the NSAID with nonweight-bearing exercises ( NE ; n = 49 ) , ( 3 ) the NSAID combined with walking ( NW ; n = 35 ) , ( 4 ) an energy restriction diet plus the NSAID ( ND ; n = 29 ) , ( 5 ) the diet combined with the NSAID and strengthening exercises ( NDE ; n = 37 ) , or ( 6 ) the diet combined with the NSAID and walking ( NDW ; n = 26 ) . Body weight and lower extremity lean body mass ( L-LBM ) , assessed with segmental bioelectrical impedance , were measured at the outset and at 8 weeks in the six therapy groups . Interval changes in L-LBM and L-LBM per body weight ( L-LBM/weight ) were compared among the six groups at the conclusion . The Lequesne index can index of severity of osteoarthritis of the knee at the final assessment , compared with that at the initial assessment , was significantly decreased in the NE group , but not in the NW or the NA groups ( P = 0.023 ) . There was a significant increase in the L-LBM/weight in the NE group , but not in the NA or NW groups ( P = 0.002 between NE and NA ; P = 0.019 between NE and NW ) . There was a significant reduction in the Lequesne index in the NDE group in comparison with the ND and NDW groups ( P = 0.0001 between NDE and ND ; P = 0.0001 between NDE and NDW ) . There was a significant increase in L-LBM/weight in the NDE group , but not in the NDW or the ND groups ( P = 0.011 ) . Adjunctive therapy with nonweight-bearing lower extremity exercises appears to be more efficacious for prevention of lower extremity loss of muscle mass than adjunctive therapy with walking for obese women with knee OA",
"OBJECTIVE To examine the effect of weight changes between 20 and 50 years of age on the risk of severe knee osteoarthritis ( OA ) requiring arthroplasty . SUBJECTS AND METHODS Cases were 55 - 75 year old men and women ( n = 220 ) having had knee arthroplasty for primary osteoarthritis at the Kuopio University Hospital in 1992 - 93 . Controls ( n = 415 ) were r and omly selected from the population of Kuopio Province . Weight at the age of 20 , 30 , 40 , and 50 years was collected retrospectively with a postal question naire . RESULTS After adjustment for age , sex , history of physical workload , recreational physical activity , and previous knee injury , weight gain result ing to a shift from normal body mass index ( BMI 25 kg/m(2 ) ) was associated with a higher relative risk of knee OA requiring arthroplasty than persistent overweight from 20 - 50 years of age , compared with those with normal relative weight during the corresponding age period . The odds ratios ( OR ) were 3.07 ( 95 % confidence interval 1.87 to 5.05 ) for those with normal weight at the age of 20 years and overweight at two or three of the ages 30 , 40 or 50 years , 3.15 ( 1.85 to 5.36 ) for those with overweight from the age of 30 years , and 2.37 ( 1.21 to 4.62 ) for those with overweight from the age of 20 years , respectively . CONCLUSION In adult life , a shift from normal to overweight may carry a higher risk for knee OA requiring arthroplasty than does constant overweight"
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To systematic ally search for the availability of evidence for exercise impacting on sleep for people who have rheumatoid arthritis . Two review ers independently search ed seven electronic data bases , identified and extracted relevant studies by applying eligibility criteria . Sources of bias were assessed independently by two review ers using the Cochrane bias assessment tool for r and omized controlled trials ( RCTs ) and Newcastle – Ottawa Quality Assessment Scale for non- RCTs . Data were synthesized using a level of evidence approach . Meta-analyses were deemed to be inappropriate due to the heterogeneity of study design s , measurement tools and interventions . Five studies were included : one RCT ; two pilot RCTs and two sample s of convenience . A total of 262 people with RA were included . Interventions used were difficult to assess due to the heterogeneity of study design s and the inclusion of two using different types of yoga as an intervention . Different sleep outcome measures were used thus , it was not feasible to pool results . Studies had a high risk of bias . This review could find no consistent or conclusive evidence on whether exercise impacts on sleep in people who have rheumatoid arthritis , therefore no firm conclusions can be made . However , there is some indication that exercise may have positive benefits on sleep in people who have rheumatoid arthritis . Further studies with improved study design s , using subjective and objective measures , are needed
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"PURPOSE / OBJECTIVES To examine the relationships among fatigue and physical and mental quality of life ( QOL ) and different adjuvant chemotherapy regimens in patients with stage I-IIIA breast cancer prior to , during , and after treatment . DESIGN Longitudinal , descriptive design embedded in a r and omized , clinical trial . SETTING Outpatient oncology clinics in the midwestern United States . SAMPLE 196 postoperative women , mean age of 52 years , receiving anthracycline-based chemotherapy regimens : dose-dense taxane , dose-st and ard taxane , or dose-st and ard without taxane . METHODS The Piper Fatigue Scale and Medical Outcomes Study SF-36(R ) ( v.2 ) Survey were completed 48 hours prior to treatment 1 , at treatments 4 and 8 , and 30 days after the final treatment . MAIN RESEARCH VARIABLES Fatigue , adjuvant chemotherapy regimen , and QOL . FINDINGS Fatigue and mental QOL changed significantly over time for all regimens , but the patterns of change did not differ based on regimen . Physical QOL changed significantly over time for all regimens , and the pattern of change differed based on whether taxanes were received . Higher fatigue was correlated with lower physical and mental QOL prior to and 30 days after the final treatment , regardless of regimen . CONCLUSIONS Women who receive taxanes are at higher risk for lower physical QOL over time . Higher fatigue was associated with lower QOL regardless of the chemotherapy regimens . IMPLICATION S FOR NURSING Clinicians should screen patients for fatigue and assess for contributing factors at clinic visits . Methods to integrate evidence -based fatigue interventions into practice should be tested and outcomes evaluated",
"OBJECTIVES : Sleep disturbances are common in patients with gastroesophageal reflux disease ( GERD ) . This study examined the effects of esomeprazole on nighttime heartburn , GERD-related sleep disturbances , sleep quality , work productivity , and regular activities . METHODS : This multicenter , r and omized , double-blind , placebo-controlled trial included adults with GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn ( recorded by patient diary during screening ) . Patients received oral esomeprazole 40 mg ( n = 220 ) or 20 mg ( n = 226 ) or placebo ( n = 229 ) once daily for 4 wk . The primary outcome was relief of nighttime heartburn . Secondary outcomes included resolution of sleep disturbances , sleep quality measured by the Pittsburgh Sleep Quality Index ( PSQI ) question naire , and work productivity measured by the Work Productivity and Activity Impairment Question naire . RESULTS : Nighttime heartburn was relieved in 53.1 % ( 111/209 ) , 50.5 % ( 111/220 ) , and 12.7 % ( 28/221 ) of patients who received esomeprazole 40 mg , esomeprazole 20 mg , and placebo , respectively . Differences ( 95 % CI ) versus placebo were 40.5 % ( 32.4 % , 48.5 % ) and 37.8 % ( 29.9 % , 45.7 % ) and were highly significant ( p GERD-related sleep disturbances resolved in significantly more ( p PSQI global score changes from baseline ( p heartburn and GERD-related sleep disturbances and improved sleep quality and work productivity",
"Objective . Sleep disturbance and chronic fatigue are common in rheumatoid arthritis ( RA ) and contribute to disability , symptomatology , and healthcare use . It has long been recognized in other population s that exercise can improve sleep and diminish fatigue . The effect of exercise on sleep quality and fatigue in RA has not been evaluated . Methods . Ours is a r and omized controlled study in RA to determine the effect of an exercise program on sleep quality and fatigue . These were measured using the Pittsburgh Sleep Quality Index and the Fatigue Severity Scale . Patients were r and omized to either a 12-week , home-based exercise intervention or usual care . The exercise program consisted of specific exercises to target individual deficiencies identified using the Health Assessment Question naire ( HAQ ) with cardiovascular work as per the guidelines . The intervention group was evaluated on a 3-week basis . Full evaluation was carried out at baseline and at 12 weeks . Results . Forty patients were r and omized to the intervention with 38 controls . In the exercise intervention group , there was a statistically significant improvement in HAQ ( p = 0.00 ) , pain ( p = 0.05 ) , stiffness ( p = 0.05 ) , sleep quality ( p = 0.04 ) , and fatigue ( p = 0.04 ) . In our control group , there was a statistically significant improvement demonstrated in their overall perceptions of the benefits of exercise , but none of the other variables . Conclusion . Our study demonstrates that an exercise program result ed in significant improvement in sleep quality and fatigue . This is particularly interesting given the importance of fatigue as an outcome measure in RA and gives us yet another reason to prescribe exercise in this population",
"OBJECTIVE Exercise can improve sleep quality , but for whom and by what means remains unclear . We examined moderators and mediators of objective sleep improvements in a 12-month r and omized controlled trial among underactive midlife and older adults reporting mild/moderate sleep complaints . METHODS Participants ( N = 66 , 67 % women , 55 - 79 years ) were r and omized to moderate-intensity exercise or health education control . Putative moderators were gender , age , physical function , self-reported global sleep quality , and physical activity levels . Putative mediators were changes in BMI , depressive symptoms , and physical function at 6 months . Objective sleep outcomes measured by in-home polysomnography were percent time in Stage I sleep , percent time in Stage II sleep , and number of awakenings during the first third of sleep at 12 months . RESULTS Baseline physical function and sleep quality moderated changes in Stage I sleep ; individuals with higher initial physical function ( p = .01 ) and poorer sleep quality ( p = .03 ) had greater improvements . Baseline physical activity level moderated changes in Stage II sleep ( p = .04 ) and number of awakenings ( p = .01 ) ; more sedentary individuals had greater improvements . Decreased depressive symptoms ( CI:-1.57 to -0.02 ) mediated change in Stage I sleep . Decreased depressive symptoms ( CI:-0.75 to -0.01 ) , decreased BMI ( CI:-1.08 to -0.06 ) , and increased physical function ( CI : 0.01 to 0.72 ) mediated change in number of awakenings . CONCLUSIONS Initially less active individuals with higher initial physical function and poorer sleep quality improved the most . Affective , functional , and metabolic mediators specific to sleep architecture parameters were suggested . These results indicate strategies to more efficiently treat poor sleep through exercise in older adults",
"Patients with neurological diseases often suffer from sleep disturbances . Insomnia among adult brain tumor patients has usually been studied as part of quality -of-life studies , or some case reports on insomnia in these patients have been described . The authors aim ed to study insomnia in a prospect i ve study setting among patients with primary brain tumors and evaluate whether insomnia is related to tumor laterality . Entire study population consisted of 70 patients with a solitary primary supratentorial brain tumor treated surgically at the Clinic for Neurosurgery , Oulu University Hospital . The overall functional state of the patients was assessed by the Karnofsky Performance Scale , depression was measured by Beck Depression Inventory , and insomnia by Nottingham Health Profile . Repeated measurements were assessed before tumor operation as well as 3 months and one year after surgery . Prevalence of insomnia among patients with a primary brain tumor waiting for surgery was higher compared to general population , but level of insomnia significantly decreased as soon as 3 months after tumor operation . Patients with a bilateral primary brain tumor had significantly more often insomnia without comorbid depression compared to patients with a left or right tumor for up to one year after operation . The authors suggest that insomnia among patients with a bilateral brain tumor may not be associated with depression but have other biological background",
"OBJECTIVE To evaluate the basic 8-week People with Arthritis Can Exercise ( PACE ) program for improvements in primary ( symptoms , functioning , level of physical activity ) and secondary ( psychosocial ) outcomes . METHODS A total of 346 individuals with self-reported arthritis from 18 sites participated in a r and omized controlled trial of PACE . Outcomes were measured at baseline and 8 weeks . The intervention group completed self-reported assessment s at 3 and 6 months . Two-level multiple linear regression models were estimated to calculate adjusted outcome means in the intervention and control groups . A mixed-effects repeated- measures model was used to calculate adjusted means in the intervention group at 3 and 6 months . Both intent-to-treat ( ITT ) and as-treated ( AT ) analyses were conducted . RESULTS At 8 weeks , the intervention group had improvements in the following outcomes : 2 symptom outcomes ( pain , fatigue ) and 1 psychosocial outcome ( self-efficacy for managing arthritis ) in the ITT analyses ; 1 symptom outcome ( pain ) , 1 function outcome ( chair st and s ) , and 1 psychosocial outcome ( self-efficacy for arthritis management ) in the AT analyses . In addition , completers who attended > or=9 classes had improvements in 3 symptom outcomes ( pain , fatigue , stiffness ) , 2 function outcomes ( 10-pound lifts , chair st and s ) , and 1 psychosocial outcome ( self-efficacy for arthritis management ) at 8 weeks . Relative to baseline , PACE participants maintained significant improvements in symptoms at 6 months , but declined in function and self-efficacy for exercise . CONCLUSION If adults with arthritis attend a majority of PACE classes , they may expect improvements in symptoms , self-efficacy for arthritis management , and upper and lower extremity function . Achieving sustained improvement in outcomes may require continued participation in PACE",
"Background : Insomnia is a prevalent health complaint that is often difficult to evaluate reliably . There is an important need for brief and valid assessment tools to assist practitioners in the clinical evaluation of insomnia complaints . Objective : This paper reports on the clinical validation of the Insomnia Severity Index ( ISI ) as a brief screening measure of insomnia and as an outcome measure in treatment research . The psychometric properties ( internal consistency , concurrent validity , factor structure ) of the ISI were evaluated in two sample s of insomnia patients . Methods : The first study examined the internal consistency and concurrent validity of the ISI in 145 patients evaluated for insomnia at a sleep disorders clinic . Data from the ISI were compared to those of a sleep diary measure . In the second study , the concurrent validity of the ISI was evaluated in a sample of 78 older patients who participated in a r and omized-controlled trial of behavioral and pharmacological therapies for insomnia . Change scores on the ISI over time were compared with those obtained from sleep diaries and polysomnography . Comparisons were also made between ISI scores obtained from patients , significant others , and clinicians . Results : The results of Study 1 showed that the ISI has adequate internal consistency and is a reliable self-report measure to evaluate perceived sleep difficulties . The results from Study 2 also indicated that the ISI is a valid and sensitive measure to detect changes in perceived sleep difficulties with treatment . In addition , there is a close convergence between scores obtained from the ISI patient 's version and those from the clinician 's and significant other 's versions . Conclusions : The present findings indicate that the ISI is a reliable and valid instrument to quantify perceived insomnia severity . The ISI is likely to be a clinical ly useful tool as a screening device or as an outcome measure in insomnia treatment research",
"We examined individual responses to cognitive-behavior therapy for insomnia in 51 persons with chronic pain to determine the rate of clinical ly significant change and to identify predictors of successful treatment response . Outcome measures consisted of the Pittsburgh Sleep Quality Index ( PSQI ) and diary measures of sleep latency and sleep continuity . Using reliable change indices , 57 % of participants were statistically improved on the PSQI after 7 weeks of treatment , but only 18 % were considered fully recovered from their sleep problems . No demographic variables predicted treatment response but persons who reliably improved on the PSQI had a lower sleep self-efficacy at baseline . Improvers showed a significant increase in sleep self-efficacy ratings and a decrease in self-reported levels of distress and pain-related disability . These results suggest that patients with insomnia secondary to chronic medical conditions can be helped with cognitive-behavior therapy , although most individuals continue to have mild or subthreshold sleep problems at posttreatment",
"OBJECTIVE To investigate the generalizability of the results of a r and omized controlled trial on the effectiveness of long-term , high-intensity exercises in the rheumatoid arthritis patients in training ( RAPIT ) trial by comparing the characteristics of the participants with the non participants . METHODS Participants and non participants were mailed question naires on sociodemographic characteristics , health status , reasons not to participate , and attitudes toward intensive exercise . RESULTS The question naires from 892 ( 75 % ) non participants and 299 ( 97 % ) participants were collected . The non participants were slightly older , more often male , and had longer disease duration than the participants . The non participants perceived their disease as more serious , used fewer disease-modifying antirheumatic drugs , had a lower level of education , and a more negative attitude toward intensive exercise . CONCLUSION The results of the RAPIT trial might not be generalizable to the entire target population . To promote participation in long-term , high-intensity exercises , health professionals should more actively discuss the potential benefits of exercise with their RA patients while taking into consideration specific factors related to participation",
"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",
"Summary Pain and depression were related to sleep disturbance in rheumatoid arthritis . Depression partly mediated the relationship between pain and sleep . ABSTRACT The objective of this article is to assess the contribution of disease activity , pain , and psychological factors to self‐reported sleep disturbance in patients with rheumatoid arthritis ( RA ) , and to evaluate whether depression mediates the effects of pain on sleep disturbance . The sample included 106 patients with confirmed RA who participated in an assessment of their disease activity , pain , psychological functioning , and sleep disturbance during a baseline evaluation prior to participating in a prospect i ve study to help them manage their RA . Self‐ measures included the Rapid Assessment of Disease Activity in Rheumatology , the SF‐36 Pain Scale , the Helplessness and Internality Subscales of the Arthritis Helplessness Index , the Active and Passive Pain Coping Scales of the Pain Management Inventory , the Center for Epidemiological Studies Depression Scale , and the Pittsburgh Sleep Quality Index . Hierarchical multiple regression analysis confirmed that higher income , pain , internality , and depression contributed independently to higher sleep disturbance . A mediational analysis demonstrated that depression acted as a significant mechanism through which pain contributed to sleep disturbance . Cross‐sectional findings indicate that pain and depression play significant roles in self‐reported sleep disturbance among patients with RA . The data suggest the importance of interventions that target pain and depression to improve sleep in this medical condition",
"BACKGROUND This study , conducted between 1998 and 2001 and analyzed in 2002 and 2003 , was design ed to test ( 1 ) whether exercise is an efficacious treatment for mild to moderate major depressive disorder ( MDD ) , and ( 2 ) the dose-response relation of exercise and reduction in depressive symptoms . DESIGN The study was a r and omized 2x2 factorial design , plus placebo control . SETTING / PARTICIPANTS All exercise was performed in a supervised laboratory setting with adults ( n = 80 ) aged 20 to 45 years diagnosed with mild to moderate MDD . INTERVENTION Participants were r and omized to one of four aerobic exercise treatment groups that varied total energy expenditure ( 7.0 kcal/kg/week or 17.5 kcal/kg/week ) and frequency ( 3 days/week or 5 days/week ) or to exercise placebo control ( 3 days/week flexibility exercise ) . The 17.5-kcal/kg/week dose is consistent with public health recommendations for physical activity and was termed \" public health dose \" ( PHD ) . The 7.0-kcal/kg/week dose was termed \" low dose \" ( LD ) . MAIN OUTCOME MEASURES The primary outcome was the score on the 17-item Hamilton Rating Scale for Depression ( HRSD(17 ) ) . RESULTS The main effect of energy expenditure in reducing HRSD(17 ) scores at 12 weeks was significant . Adjusted mean HRSD(17 ) scores at 12 weeks were reduced 47 % from baseline for PHD , compared with 30 % for LD and 29 % for control . There was no main effect of exercise frequency at 12 weeks . CONCLUSIONS Aerobic exercise at a dose consistent with public health recommendations is an effective treatment for MDD of mild to moderate severity . A lower dose is comparable to placebo effect"
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BACKGROUND Hypertension is a major risk factor for the development of stroke . It is well known that lowering blood pressure decreases the risk of stroke in people with moderate to severe hypertension . However , the specific effects of calcium channel blockers ( CCBs ) against stroke in patients with hypertension as compared to no treatment and other antihypertensive drug classes are not known . METHODS AND FINDINGS This systematic review and meta- analysis of r and omized controlled trials ( RCTs ) evaluated CCBs effect on stroke in patients with hypertension in studies of CCBs versus placebo , angiotensin-converting-enzyme inhibitors ( ACEIs ) , β-adrenergic blockers , and diuretics . The PUBMED , MEDLINE , EMBASE , OVID , CNKI , MEDCH , and WANFANG data bases were search ed for trials published in English or Chinese during the period January 1 , 1996 to July 31 , 2012 . A total of 177 reports were collected , among them 31 RCTs with 273,543 participants ( including 130,466 experimental subjects and 143,077 controls ) met the inclusion criteria . In these trials a total of 9,550 stroke events ( 4,145 in experimental group and 5,405 in control group ) were reported . CCBs significantly decreased the incidence of stroke compared with placebo ( OR = 0.68 , 95 % CI 0.61 - 0.75 , p between CCBs and ACEIs ( OR = 0.92 , 95 % CI 0.8 - 1.02 , p = 0.12 ) or diuretics ( OR = 0.95 , 95 % CI 0.84 - 1.07 , p = 0.39 ) . CONCLUSION In a pooled analysis of data of 31 RCTs measuring the effect of CCBs on stroke , CCBs reduced stroke more than placebo and β-adrenergic blockers , but were not different than ACEIs and diuretics . More head to head RCTs are warranted
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"BACKGROUND Recent reports suggest that calcium-channel blockers may be harmful in patients with diabetes and hypertension . We previously reported that antihypertensive treatment with the calcium-channel blocker nitrendipine reduced the risk of cardiovascular events . In this post hoc analysis , we compared the outcome of treatment with nitrendipine in diabetic and nondiabetic patients . METHODS After stratification according to center , sex , and presence or absence of previous cardiovascular complications , 4695 patients ( age , > or = 60 years ) with systolic blood pressure of 160 to 219 mm Hg and diastolic pressure below 95 mm Hg were r and omly assigned to receive active treatment or placebo . Active treatment consisted of nitrendipine ( 10 to 40 mg per day ) with the possible addition or substitution of enalapril ( 5 to 20 mg per day ) or hydrochlorothiazide ( 12.5 to 25 mg per day ) or both , titrated to reduce the systolic blood pressure by at least 20 mm Hg and to less than 150 mm Hg . In the control group , matching placebo tablets were administered similarly . RESULTS At r and omization , 492 patients ( 10.5 percent ) had diabetes . After a median follow-up of two years , the systolic and diastolic blood pressures in the placebo and active-treatment groups differed by 8.6 and 3.9 mm Hg , respectively , among the diabetic patients . Among the 4203 patients without diabetes , systolic and diastolic pressures differed by 10.3 and 4.5 mm Hg , respectively , in the two groups . After adjustment for possible confounders , active treatment was found to have reduced overall mortality by 55 percent ( from 45.1 deaths per 1000 patients to 26.4 deaths per 1000 patients ) , mortality from cardiovascular disease by 76 percent , all cardiovascular events combined by 69 percent , fatal and nonfatal strokes by 73 percent , and all cardiac events combined by 63 percent in the group of patients with diabetes . Among the nondiabetic patients , active treatment decreased all cardiovascular events combined by 26 percent and fatal and nonfatal strokes by 38 percent . In the group of patients receiving active treatment , reductions in overall mortality , mortality from cardiovascular disease , and all cardiovascular events were significantly larger among the diabetic patients than among the nondiabetic patients ( P=0.04 , P=0.02 , and P=0.01 , respectively ) . CONCLUSIONS Nitrendipine-based antihypertensive therapy is particularly beneficial in older patients with diabetes and isolated systolic hypertension . Thus , our findings do not support the hypothesis that the use of long-acting calcium-channel blockers may be harmful in diabetic patients",
"Background and Purpose — In hypertensive stroke patients , for the same level of blood pressure control , eprosartan will be more effective than nitrendipine in reducing cerebrovascular and cardiovascular morbidity and mortality . Methods — A total of 1405 well-defined , high-risk hypertensives with cerebral event during the last 24 months ( proven by cerebral computed tomography scan or nuclear magnetic resonance ) were r and omized to eprosartan or nitrendipine ( mean follow-up 2.5 years ) . Primary end point was the composite of total mortality and all cardiovascular and cerebrovascular events , including all recurrent events . Results — R and omization was successful without significant differences in the baseline characteristics . Blood pressure was reduced to a comparable extent without any significant differences between the 2 groups during the whole study period ( 150.7/84 mm Hg and 152.0/87.2 mm Hg with eprosartan and nitrendipine therapy to 137.5/80.8 mm Hg and 136.0/80.2 mm Hg , respectively , confirmed by ambulatory blood pressure monitoring ) . Moreover , already after 3 months , normotensive mean values were achieved , and 75.5 % reached values eprosartan regimen and 77.7 % with the nitrendipine regimen . During follow-up , in total , 461 primary events occurred : 206 eprosartan and 255 nitrendipine ( incidence density ratio [ IDR ] , 0.79 ; 95 % CI , 0.66 to 0.96 ; P=0.014 ) . Cardiovascular events were : 77 eprosartan and 101 nitrendipine ( IDR , 0.75 ; 95 % CI , 0.55 to 1.02 ; P=0.06 ) ; cerebrovascular events : 102 eprosartan and 134 nitrendipine ( IDR , 0.75 ; 95 % CI , 0.58 to 0.97 ; P=0.03 ) . Conclusions — The Morbidity and Mortality After Stroke , Eprosartan Compared With Nitrendipine for Secondary Prevention ( MOSES ) study was the first to compare an angiotensin II type 1 receptor antagonist with a calcium antagonist in secondary stroke prevention . In these high-risk hypertensive stroke patients , an early normotensive and comparable blood pressure was achieved . The combined primary end point was significantly lower in the eprosartan group",
"OBJECTIVE To assess the effectiveness of nifedipine treatment in elderly hypertensives . METHODS A single-blind trial was conducted under the direction of the Shanghai Institute of Hypertension in 1632 subjects aged 60 - 79 years alternatively allocated to either nifedipine or placebo after a 4-week placebo run-in period between 1987 and 1990 with mean follow-up of 30 months . Clinical events and risk modification were analysed in collaboration with the University of Montreal . Seventy-four patients with severe hypertension were reallocated to active nifedipine treatment after placebo run-in . RESULTS Cox 's proportional hazards model accounting for covariates demonstrated a highly significant decrease in the probability of events : ' original treatment assignment ' analysis indicated that 77 events occurred in the placebo and 32 in the nifedipine group . Similar significance s were achieved with ' actual treatment ' or ' changes excluded ' ( excluding reallocated subjects ) analyses . A significant reduction in relative risk was observed for strokes and severe arrhythmia with an overall decrease from 1.0 to 0.41 ( 95 % confidence interval 0.27 - 0.61 ) . CONCLUSION Nifedipine treatment diminished the number of severe clinical outcomes in elderly hypertensives significantly",
"BACKGROUND Calcium antagonists are a first-line treatment for hypertension . The effectiveness of diltiazem , a non-dihydropyridine calcium antagonist , in reducing cardiovascular morbidity or mortality is unclear . We compared the effects of diltiazem with that of diuretics , beta-blockers , or both on cardiovascular morbidity and mortality in hypertensive patients . METHODS In a prospect i ve , r and omised , open , blinded endpoint study , we enrolled 10,881 patients , aged 50 - 74 years , at health centres in Norway and Sweden , who had diastolic blood pressure of 100 mm Hg or more . We r and omly assigned patients diltiazem , or diuretics , beta-blockers , or both . The combined primary endpoint was fatal and non-fatal stroke , myocardial infa rct ion , and other cardiovascular death . Analysis was done by intention to treat . FINDINGS Systolic and diastolic blood pressure were lowered effectively in the diltiazem and diuretic and beta-blocker groups ( reduction 20.3/18.7 vs 23.3/18.7 mm Hg ; difference in systolic reduction p Fatal and non-fatal stroke occurred in 159 patients in the diltiazem group and in 196 in the diuretic and beta-blocker group ( 6.4 vs 7.9 events per 1000 patient-years ; 0.80 [ 0.65 - 0.99 ] , p=0.04 ) and fatal and non-fatal myocardial infa rct ion in 183 and 157 patients ( 7.4 vs 6.3 events per 1000 patient-years ; 1.16 [ 0.94 - 1.44 ] , p=0.17 ) . INTERPRETATION Diltiazem was as effective as treatment based on diuretics , beta-blockers , or both in preventing the combined primary endpoint of all stroke , myocardial infa rct ion , and other cardiovascular death",
"CONTEXT Hypertensive patients are often given a calcium antagonist to reduce cardiovascular disease risk , but the benefit compared with other drug classes is controversial . OBJECTIVE To determine whether initial therapy with controlled-onset extended-release ( COER ) verapamil is equivalent to a physician 's choice of atenolol or hydrochlorothiazide in preventing cardiovascular disease . DESIGN , SETTING , AND PARTICIPANTS Double-blind , r and omized clinical trial conducted at 661 centers in 15 countries . A total of 16 602 participants diagnosed as having hypertension and who had 1 or more additional risk factors for cardiovascular disease were enrolled between September 1996 and December 1998 and followed up until December 31 , 2000 . After a mean of 3 years of follow-up , the sponsor closed the study before unblinding the results . INTERVENTION Initially , 8241 participants received 180 mg of COER verapamil and 8361 received either 50 mg of atenolol or 12.5 mg of hydrochlorothiazide . Other drugs ( eg , diuretic , beta-blocker , or an angiotensin-converting enzyme inhibitor ) could be added in specified sequence if needed . MAIN OUTCOME MEASURES First occurrence of stroke , myocardial infa rct ion , or cardiovascular disease-related death . RESULTS Systolic and diastolic blood pressure were reduced by 13.6 mm Hg and 7.8 mm Hg for participants assigned to the COER verapamil group and by 13.5 and 7.1 mm Hg for partcipants assigned to the atenolol or hydrochlorothiazide group . There were 364 primary cardiovascular disease-related events that occurred in the COER verapamil group vs 365 in atenolol or hydrochlorothiazide group ( hazard ratio [ HR ] , 1.02 ; 95 % confidence interval [ CI ] , 0.88 - 1.18 ; P = .77 ) . For fatal or nonfatal stroke , the HR was 1.15 ( 95 % CI , 0.90 - 1.48 ) ; for fatal or nonfatal myocardial infa rct ion , 0.82 ( 95 % CI , 0.65 - 1.03 ) ; and for cardiovascular disease-related death , 1.09 ( 95 % CI , 0.87 - 1.37 ) . The HR was 1.05 ( 95 % CI , 0.95 - 1.16 ) for any prespecified cardiovascular disease-related event and 1.08 ( 95 % CI , 0.93 - 1.26 ) for all-cause mortality . Nonstroke hemorrhage was more common with participants in the COER-verapamil group ( n = 118 ) compared with the atenolol or hydrochlorothiazide group ( n = 79 ) ( HR , 1.54 [ 95 % CI , 1.16 - 2.04 ] ; P = .003 ) . More cardiovascular disease-related events occurred between 6 AM and noon in both the COER verapamil ( 99/277 ) and atenolol or hydrochlorothiazide ( 88/274 ) groups ; HR , 1.15 ( 95 % CI , 0.86 - 1.53 ) . CONCLUSIONS The CONVINCE trial did not demonstrate equivalence of a COER verapamil-based antihypertensive regimen compared with a regimen beginning with a diuretic or beta-blocker . When considered in the context of other trials of calcium antagonists , these data indicate that the effectiveness of calcium-channel therapy in reducing cardiovascular disease is similar but not better than diuretic or beta-blocker treatment",
"OBJECTIVE ACE inhibitors and calcium antagonists may favorably affect serum lipids and glucose metabolism . The primary aim of the Fosinopril Versus Amlodipine Cardiovascular Events R and omized Trial ( FACET ) was to compare the effects of fosinopril and amlodipine on serum lipids and diabetes control in NIDDM patients with hypertension . Prospect ively defined cardiovascular events were assessed as secondary outcomes . RESEARCH DESIGN AND METHODS Inclusion criteria included a diagnosis of NIDDM and hypertension ( systolic blood pressure of > 140 mmHg or diastolic blood pressure of > 90 mmHg ) . Exclusion criteria included a history of coronary heart disease or stroke , serum creatinine > 1.5 mg/dl , albuminuria > 40 μg/min , and use of lipid-lowering drugs , aspirin , or antihypertensive agents other than beta-blockers or diuretics . A total of 380 hypertensive diabetics were r and omly assigned to open-label fosinopril ( 20 mg/day ) or amlodipine ( 10 mg/day ) and followed for up to 3.5 years . If blood pressure was not controlled , the other study drug was added . RESULTS Both treatments were effective in lowering blood pressure . At the end of followup , between the two groups there was no significant difference in total serum cholesterol , HDL cholesterol , HbA1c , fasting serum glucose , or plasma insulin . The patients receiving fosinopril had a significantly lower risk of the combined outcome of acute myocardial infa rct ion , stroke , or hospitalized angina than those receiving amlodipine ( 14/189 vs. 27/191 ; hazards ratio = 0.49 , 95 % CI = 0.26–0.95 ) . CONCLUSIONS Fosinopril and amlodipine had similar effects on biochemical measures , but the patients r and omized to fosinopril had a significantly lower risk of major vascular events , compared with the patients r and omized to amlodipine ",
"Background —Most cardiovascular events associated with hypertension are complications of atherosclerosis . Some antihypertensive agents influence experimental models of atherosclerosis through mechanisms independent of blood pressure lowering . Methods and Results —The European Lacidipine Study on Atherosclerosis ( ELSA ) was a r and omized , double-blind trial in 2334 patients with hypertension that compared the effects of a 4-year treatment based on either lacidipine or atenolol on an index of carotid atherosclerosis , the mean of the maximum intima-media thicknesses ( IMT ) in far walls of common carotids and bifurcations ( CBMmax ) . This index has been shown by epidemiological studies to be predictive of cardiovascular events . A significant ( P lacidipine was found compared with atenolol , with a treatment difference in 4-year CBMmax progression of −0.0227 mm ( intention-to-treat population ) and −0.0281 mm ( completers ) . The yearly IMT progression rate was 0.0145 mm/y in atenolol-treated and 0.0087 mm/y in lacidipine-treated patients ( completers , 40 % reduction;P = 0.0073 ) . Patients with plaque progression were significantly less common , and patients with plaque regression were significantly more common in the lacidipine group . Clinic blood pressure reductions were identical with both treatments , but 24-hour ambulatory systolic/diastolic blood pressure changes were greater with atenolol ( −10/−9 mm Hg ) than with lacidipine ( −7/−5 mm Hg ) . No significant difference between treatments was found in any cardiovascular events , although the relative risk for stroke , major cardiovascular events , and mortality showed a trend favoring lacidipine . Conclusion —The greater efficacy of lacidipine on carotid IMT progression and number of plaques per patient , despite a smaller ambulatory blood pressure reduction , indicates an antiatherosclerotic action of lacidipine independent of its antihypertensive action",
"BACKGROUND Calcium antagonists are widely prescribed for angina pectoris but their effect on clinical outcome is controversial . We aim ed to investigate the effect of the calcium antagonist nifedipine on long-term outcome in patients with stable angina pectoris . METHODS We r and omly assigned 3825 patients with treated stable symptomatic coronary disease to double-blind addition of nifedipine GITS ( gastrointestinal therapeutic system ) 60 mg once daily and 3840 to placebo . The primary endpoint was the combination of death , acute myocardial infa rct ion , refractory angina , new overt heart failure , debilitating stroke , and peripheral revascularisation . Mean follow-up was 4.9 years ( SD 1.1 ) . Analysis was by intention to treat . FINDINGS 310 patients allocated nifedipine died ( 1.64 per 100 patient-years ) compared with 291 people allocated placebo ( 1.53 per 100 patient-years ; hazard ratio 1.07 [ 95 % CI 0.91 - 1.25 ] , p=0.41 ) . Primary endpoint rates were 4.60 per 100 patient-years for nifedipine and 4.75 per 100 patient-years for placebo ( 0.97 [ 0.88 - 1.07 ] , p=0.54 ) . With nifedipine , rate of death and any cardiovascular event or procedure was 9.32 per 100 patient-years versus 10.50 per 100 patient-years for placebo ( 0.89 [ 0.83 - 0.95 ] , p=0.0012 ) . The difference was mainly attributable to a reduction in the need for coronary angiography and interventions in patients assigned nifedipine , despite an increase in peripheral revascularisation . Nifedipine had no effect on the rate of myocardial infa rct ion . INTERPRETATION Addition of nifedipine GITS to conventional treatment of angina pectoris has no effect on major cardiovascular event-free survival . Nifedipine GITS is safe and reduces the need for coronary angiography and interventions",
"BACKGROUND The efficacy of new antihypertensive drugs has been question ed . We compared the effects of conventional and newer antihypertensive drugs on cardiovascular mortality and morbidity in elderly patients . METHODS We did a prospect i ve , r and omised trial in 6614 patients aged 70 - 84 years with hypertension ( blood pressure > or = 180 mm Hg systolic , > or = 105 mm Hg diastolic , or both ) . Patients were r and omly assigned conventional antihypertensive drugs ( atenolol 50 mg , metoprolol 100 mg , pindolol 5 mg , or hydrochlorothiazide 25 mg plus amiloride 2.5 mg daily ) or newer drugs ( enalapril 10 mg or lisinopril 10 mg , or felodipine 2.5 mg or isradipine 2 - 5 mg daily ) . We assessed fatal stroke , fatal myocardial infa rct ion , and other fatal cardiovascular disease . Analysis was by intention to treat . FINDINGS Blood pressure was decreased similarly in all treatment groups . The primary combined endpoint of fatal stroke , fatal myocardial infa rct ion , and other fatal cardiovascular disease occurred in 221 of 2213 patients in the conventional drugs group ( 19.8 events per 1000 patient-years ) and in 438 of 4401 in the newer drugs group ( 19.8 per 1000 ; relative risk 0.99 [ 95 % CI 0.84 - 1.16 ] , p=0.89 ) . The combined endpoint of fatal and non-fatal stroke , fatal and non-fatal myocardial infa rct ion , and other cardiovascular mortality occurred in 460 patients taking conventional drugs and in 887 taking newer drugs ( 0.96 [ 0.86 - 1.08 ] , p=0.49 ) . INTERPRETATION Old and new antihypertensive drugs were similar in prevention of cardiovascular mortality or major events . Decrease in blood pressure was of major importance for the prevention of cardiovascular events",
"The NIsoldipine in COronary artery disease in LEuven ( NICOLE ) study investigates ( 1 ) whether nisoldipine , a dihydropyridine calcium antagonist , reduces the progression of minor coronary arterial lesions in the long term , and ( 2 ) whether it reduces the restenosis rate after successful percutaneous transluminal coronary angioplasty ( PTCA ) . The NICOLE study is a single-center , r and omized , double-blind trial in 826 patients , who underwent a successful PTCA . Nisoldipine 40 mg coat-core or placebo was started the morning after the procedure and continued for 3 years . All coronary arterial segments were measured on preprocedural angiogram and on the second follow-up angiogram at 3 years . On the first follow-up angiogram at 6 months only the dilated segments were measured . Although the study is still ongoing until the primary end point is reached , we report in this study the angiographic restenosis data as well as the clinical events observed at 6-month follow-up . The per- protocol population consisted of 646 patients . Restenosis , defined as a > or = 50 % loss of the initial gain ( National Heart , Lung , and Blood Institute criterion IV ) occurred in 49 % and 55 % of the 308 nisoldipine-treated and the 338 placebo-treated patients , respectively ( p = NS ) . At follow-up , the rates of death and myocardial infa rct ion were low and similar in both groups , but in the nisoldipine group , less patients required early coronary angiography ( 18 % vs 26 % , p = 0.006 ) and subsequent revascularization procedures ( 32 % vs 41 % , p = 0.057 ) . Thus , nisoldipine did not significantly reduce the angiographic restenosis rate after PTCA , but reduced the number of repeat revascularization procedures , which may be due to its antianginal action",
"Objective : Our aim was to compare the effect of lacidipine and chlorthalidone on cardiovascular outcome as a primary parameter and blood pressure as a secondary in elderly patients with isolated systolic hypertension in a prospect i ve study with an open design . Methods : 1882 males and females out patients ≥60 years were r and omly assigned to the administration of chlorthalidone 12.5 mg o.d . or lacidipine 4 mg o.d . Patients were recruited if sitting systolic blood pressure was ≥160 mmHg with a diastolic blood pressure equal or lower than 95 mmHg . Primary endpoint was a composite of cardiovascular and cerebrovascular events . Results : At r and omization mean systolic blood pressure was 178.1 mmHg in the lacidipine and 178.2 mmHg in the chlorthalidone group , the corresponding mean diastolic values being 86.9 and 86.8 mmHg . In both lacidipine and chlorthalidone groups treatment caused a significant ( p and marked systolic blood pressure reduction which was maintained throughout the treatment period with a significant ( p in diastolic blood pressure as well . At the end of treatment period ( median 32 months ) , the reduction was 36.8/8.1 mmHg ( systolic/diastolic ) in the chlorthalidone and 38.4/7.9 mmHg in the lacidipine group , the final on treatment blood pressures being 142.0/79.2 and 143.2/79.5 mmHg , respectively . Treatments were similarly effective in males and females and in age groups between 60 and 69 years ( n = 763 ) , 70 and 79 years ( n = 744 ) and ≥80 years ( n = 375 ) . Similar reductions were obtained in a subgroup of patients ( n = 209 ) followed in double-blind fashion for 1 year . The overall incidence of the primary endpoints was 9.3 % with no significant between-group difference . Total mortality was also similar between groups . Conclusions : In elderly patients with isolated systolic hypertension , administration of lacidipine or chlorthalidone markedly reduced systolic blood pressure with no difference in the incidence of cardiovascular events and total mortality",
"Context Previously published results of this r and omized , double-blind trial showed that high-risk patients with type 2 diabetic nephropathy had better renal protection if they were treated with irbesartan rather than amlodipine in addition to conventional antihypertensive therapy . Contribution These detailed analyses showed no differences in overall cardiovascular outcomes between patients given irbesartan or amlodipine . Fewer patients given irbesartan had heart failure and fewer patients given amlodipine had heart attacks . Caution s The trial had limited power to detect important differences between groups in mortality or strokes , and most patients received several antihypertensive agents . The Editors Patients with diabetes have an increased risk for cardiovascular complications and death ( 1 ) . Studies that analyzed the effects of inhibition of the reninangiotensin system on the risk for cardiovascular complications included a substantial number of patients with diabetes ( 2 - 5 ) or were done exclusively in patients with diabetes ( 6 - 8 ) . The meta- analysis of these studies ( 9 ) , the analysis of the diabetic cohorts in the Heart Outcomes Prevention Evaluation ( HOPE ) study ( 2 ) , and the Losartan Intervention for Endpoint Reduction in Hypertension ( LIFE ) trial ( 5 ) demonstrated that angiotensin-converting enzyme ( ACE ) inhibitors ( 2 , 9 ) and angiotensin-receptor blockers ( 5 ) had a statistically significant advantage over placebo or alternative agents in decreasing the risk for several cardiovascular events . These studies r and omly assigned few patients with renal involvement and overt proteinuria . Overt proteinuria occurred in fewer than 20 % of the 470 patients in the Appropriate Blood Pressure Control in Diabetes ( ABCD ) trial ( 6 ) , and only 11 % of the 1195 patients in the LIFE trial ( 5 ) . The Captopril Prevention Project ( CAPP ) ( 3 ) and the Swedish Trial in Old Patients with Hypertension-2 ( STOP Hypertension-2 ) ( 4 ) did not state the number of patients with diabetes and overt proteinuria . There were no such patients in the Fosinopril versus Amlodipine Cardiovascular Events Trial ( FACET ) ( 7 ) , and patients with dipstick-positive albuminuria were excluded from the HOPE trial ( 2 ) . Since proteinuria is an independent risk factor for cardiovascular disease ( 10 , 11 ) , the data obtained in the aforementioned trials can not be extrapolated to patients with type 2 diabetes and overt nephropathy . Trials performed in such patients have reported a blood pressureindependent effect of two different angiotensin-receptor blocker agents to protect against nephropathy ( 12 , 13 ) without a change in all-cause mortality . Apart from studies in heart failure , few cardiovascular data exist for receptor blockers compared with either placebo or calcium-channel blockers . We report on the analysis of the cardiovascular end points that were monitored as secondary end points in the Irbesartan Diabetic Nephropathy Trial ( IDNT ) ( 12 ) and assess whether an angiotensin II receptor blocker or a calcium-channel blocker alters the risk for cardiovascular events beyond those observed by blood pressure reduction alone without such agents . Methods Patients The IDNT was a r and omized , double-blind study on the effect of treatment with irbesartan or amlodipine compared with placebo in patients with type 2 diabetic nephropathy . The protocol of this study has been published ( 12 , 14 ) . Entry criteria required that patients be between 30 and 70 years of age and have type 2 diabetes mellitus and overt nephropathy , as evidence d by current treatment for hypertension or by a protein excretion rate of 900 mg/d or greater , serum creatinine level of 89 mol/L ( 1.0 mg/dL ) to 266 mol/L ( 3.0 mg/dL ) in women or of 106 mol/L ( 1.2 mg/dL ) to 266 mol/L ( 3.0 mg/dL ) in men , and baseline seated blood pressure greater than 135/85 mm Hg . The institutional review boards of each center approved the protocol . All patients gave written informed consent . Treatment and R and omization Patients were r and omly assigned central ly by computer to receive treatment with irbesartan , 300 mg/d ( Avapro , Bristol-Myers Squibb , Princeton , New Jersey ) ; amlodipine , 10 mg/d ( Norvasc , Pfizer , New York ) ; or matched placebo . To minimize any center effect , r and omization was blocked by center . All patients had blood pressure controlled to the same blood pressure goal of less than 135/85 mm Hg by using antihypertensive agents other than ACE inhibitors , angiotensin II receptor blocking agents , or calcium-channel blockers . For the analysis of cardiovascular end points , patients were followed to initiation of treatment for end-stage renal failure ( dialysis or renal transplantation ) , reaching a serum creatinine level of 530.4 mol/L ( 6.0 mg/dL ) or higher , death , or administrative censoring in December 2000 . Outcomes We prospect ively established cardiovascular outcomes , defined in the Appendix Table . Appendix Table . Classification for Fatal and Nonfatal Cardiovascular Events Ascertainment of Cardiovascular Events Information about hospitalizations and adverse events were screened at Bristol-Myers Squibb , Princeton , New Jersey , by trained , blinded clinical research associates to identify potential cardiovascular events . Investigators used study forms to report and characterize all cardiovascular outcomes . For all potential events , records , including laboratory values , electrocardiograms , and radiographic reports were obtained for clarification . Since myocardial infa rct ions may go unrecognized , a central electrocardiogram reading center was established at Brigham and Women 's Hospital , Boston , Massachusetts , where two cardiologists review ed every electrocardiogram . Electrocardiography was performed at baseline , 6 months , 12 months , and annually thereafter . A total of 5698 electrocardiograms were review ed at the center . When a new Q-wave infa rct ion was found , the cardiologists asked whether a clinical myocardial infa rct ion was reported . Even when myocardial infa rct ions were not clinical ly reported , these Q-wave infa rct ions were adjudicated as myocardial infa rct ions . Adjudication of Cardiovascular Events Investigators at each center reported cardiovascular events , defined in the Appendix Table . The information on all potential events was referred to one member of the Outcomes Confirmation and Classification Committee ( Appendix ) . If the committee member agreed with the judgment of the center investigator , their combined judgment was accepted . If the center investigator and the committee member differed , the case material was review ed by the membership of the committee , whose decision was accepted . Deaths were adjudicated by a Mortality Committee ( Appendix ) . Each death was review ed by two members of the committee and presented to the membership , whose decision was accepted as final . Statistical Analysis For graphical presentation ( Figure ) and overall testing for statistically significant differences among the three treatment groups , time to the first occurrence of either a specific cardiovascular outcome or one of the composite outcomes was analyzed by product-limit survival curves and the log-rank test ( 15 ) . We used proportional hazards modeling to determine hazard ratios . For the cardiovascular death outcome , which could occur only once , we used the st and ard proportional hazards model ( 16 ) , with treatment assignment as the only independent covariate . For other cardiovascular outcomes , which could occur more than once , we used the And ersonGill formulation of the proportional hazards model ( 17 ) , in which patients are considered at risk for the first event from r and omization to the first event , at risk for the second event from the day following the first event to the second event , and so forth , permitting use of all the data . In accordance with the method of Lee and colleagues ( 18 ) , we used a robust variance estimate that accounts for the possibility of correlation of risk for several events within a patient . We believed that occurrence of a first event of a given type increases the likelihood of a subsequent similar event . Therefore , both treatment assignment and a time-dependent covariate indicating whether the event was the first of its type or a subsequent event were included in these analyses . The time-dependent covariate was statistically significant in each case , confirming the above assumption . There was no statistically significant interaction between treatment and the time-dependent covariatethe effects of treatment assignment were similar for first and subsequent events and inclusion of the time-dependent covariate did not change either the estimates of the treatment effect or their statistical significance s. Figure . Time to first cardiovascular composite event as a function of treatment assignment . P Data management and computations were done by using SAS software for Windows , version 8 ( SAS Institute , Inc. , Cary , North Carolina ) , or S-Plus for Windows , version 6.0 ( Insightful Corp. , Seattle , Washington ) . Statistical tests were two sided . A P value of 0.05 or less , unadjusted for the multiple comparisons , was considered statistically significant . Role of the Funding Sources The funding sources were involved in the data collection but not in the analysis or interpretation or the decision to su bmi t the manuscript for publication . Results The baseline characteristics of the three groups are shown in Table 1 . A flow diagram of the study is shown in the Appendix Figure . Table 1 . Baseline Characteristics Appendix Figure . Flow diagram for the Irbesartan Diabetic Nephropathy Trial . Clinical Management During the study , the blood pressure decreased from the baseline values to 140/77 mm Hg in the irbesartan group , 141/77 mm Hg in the amlodipine group , and 144/80 mm Hg in the placebo group . Blood pressure in the two active treatment groups did not differ ; values in both groups were statistically significantly lower than in the placebo group ( P = 0.001 ) . The distribution of non study drugs used to achieve the target blood pressure was similar",
"Objective : To perform a subgroup analysis on those patients in STOP‐Hypertension‐2 who had isolated systolic hypertension . Design and methods : The STOP‐Hypertension‐2 study evaluated cardiovascular mortality and morbidity in elderly hypertensives comparing treatment with conventional drugs ( diuretics , beta‐blockers ) with that of newer ones [ angiotensin‐converting enzyme ( ACE ) inhibitors , calcium antagonists ] . In all , 6614 elderly patients with hypertension ( mean age 76.0 years , range 70–84 years at baseline ) were included in STOP‐Hypertension‐2 . In the present subgroup analysis of STOP‐Hypertension‐2 , isolated systolic hypertension was defined as systolic blood pressure at least 160 mmHg and diastolic blood pressure below 95 mmHg , in accordance with the Syst‐Eur and Syst‐China study criteria . In total , 2280 patients in STOP‐Hypertension‐2 met these criteria . In the study , patients were r and omized to one of three treatment groups : “ conventional ” antihypertensive therapy with beta‐blockers or diuretics ( atenolol 50 mg , metoprolol 100 mg , pindolol 5 mg , or fixed‐ratio hydrochlorothiazide 25 mg plus amiloride 2.5 mg daily ) ; ACE inhibitors ( enalapril 10 mg or lisinopril 10 mg daily ) ; or calcium antagonists ( felodipine 2.5 mg or isradipine 2.5 mg daily ) . Analysis was by intention to treat . Results : The blood pressure lowering effect in patients with systolic hypertension was similar with all three therapeutic regimens : 35/13 mmHg in the conventional group ( n = 717 ) , 34/12 mmHg in the ACE inhibitor group ( n = 724 ) , and 35/13 mmHg in the calcium antagonist group ( n = 708 ) . Prevention of cardiovascular mortality , the primary endpoint of the study , did not differ between the three treatment groups . All stroke events , i.e. fatal and non‐fatal stroke together , were significantly reduced by 25 % in the newer‐drugs group compared with the conventional group ( 95 % CI 0.58–0.97 ; p = 0.027 ) . This difference was attributable to reduction of non‐fatal stroke while fatal stroke events did not differ between groups . New cases of atrial fibrillation were significantly increased by 43 % ( 95 % CI 1.02–1.99 ; p = 0.037 ) on “ newer ” drugs compared with “ conventional ” therapy , mainly attributable to the calcium antagonists . There were no significant differences between the three treatment groups with respect to the risks of myocardial infa rct ion , sudden death or congestive heart failure . Conclusions : The analysis demonstrated that “ newer ” therapy ( ACE inhibitors/calcium antagonists ) was significantly better ( 25 % ) than “ conventional ” ( diuretics/beta‐blockers ) in preventing all stroke in elderly patients with isolated systolic hypertension",
"Objective To examine the effects of nifedipine GITS on clinical outcome in patients with concurrent stable angina and hypertension . Methods Data from the double-blind placebo-controlled ACTION trial was stratified for hypertension ( blood pressure ≥ 140/90 mmHg ) , at baseline . Results A total of 52 % of 7665 ACTION patients were hypertensive . Some 80 % were on a β blocker ; hypertensives were more often treated with other blood pressure-lowering drugs . Mean baseline blood pressure was 122/74 mmHg among normotensives and 151/85 mmHg among hypertensives . Follow-up blood pressures were reduced by nifedipine ( P respectively . Nifedipine GITS significantly ( P reduced the combined incidence of all-cause mortality , myocardial infa rct ion , refractory angina , heart failure , stroke and peripheral revascularization by 13 % in hypertensives only . Nifedipine significantly reduced the incidence of any stroke or transient ischemic attack by almost 30 % in both subgroups and the need for coronary angiography by 21 % in normotensives and 16 % in hypertensives . Among hypertensives , the incidence of new overt heart failure was significantly reduced by 38 % and of debilitating stroke by 33 % . Among normotensives , the need for coronary bypass grafting was significantly reduced by 32 % . Nifedipine did not affect all-cause death , cardiovascular death and myocardial infa rct ion in either normo- or hypertensives , but increased the need for peripheral revascularization . Conclusion The salutary effects of the addition of nifedipine GITS to the basic regimen of patients with concurrent stable symptomatic coronary artery disease and hypertension emphasize the need for blood pressure control",
"BACKGROUND The efficacy of antihypertensive drugs newer than diuretics and beta-blockers has not been established . We compared the effects of the calcium-channel blocker nifedipine once daily with the diuretic combination co-amilozide on cardiovascular mortality and morbidity in high-risk patients with hypertension . METHODS We did a prospect i ve , r and omised , double-blind trial in Europe and Israel in 6321 patients aged 55 - 80 years with hypertension ( blood pressure > or = 150/95 mm Hg , or > or = 160 mm Hg systolic ) . Patients had at least one additional cardiovascular risk factor . We r and omly assigned patients nifedipine 30 mg in a long-acting gastrointestinal-transport-system ( GITS ) formulation ( n=3157 ) , or co-amilozide ( hydrochlorothiazide 25 mg [ corrected ] plus amiloride 2.5 mg ; n=3164 ) . Dose titration was by dose doubling , and addition of atenolol 25 - 50 mg or enalapril 5 - 10 mg . The primary outcome was cardiovascular death , myocardial infa rct ion , heart failure , or stroke . Analysis was done by intention to treat . FINDINGS Primary outcomes occurred in 200 ( 6.3 % ) patients in the nifedipine group and in 182 ( 5.8 % ) in the co-amilozide group ( 18.2 vs 16.5 events per 1000 patient-years ; relative risk 1.10 [ 95 % CI 0.91 - 1.34 ] , p=0.35 ) . Overall mean blood pressure fell from 173/99 mm Hg ( SD 14/8 ) to 138/82 mm Hg ( 12/7 ) . There was an 8 % excess of withdrawals from the nifedipine group because of peripheral oedema ( 725 vs 518 , p serious adverse events were more frequent in the co-amilozide group ( 880 vs 796 , p=0.02 ) . Deaths were mainly non-vascular ( nifedipine 176 vs co-amilozide 172 ; p=0.81 ) . 80 % of the primary events occurred in patients receiving r and omised treatment ( 157 nifedipine , 147 co-amilozide , difference 0.33 % [ -0.7 to 1.4 ] ) . INTERPRETATION Nifedipine once daily and co-amilozide were equally effective in preventing overall cardiovascular or cerebrovascular complications . The choice of drug can be decided by tolerability and blood-pressure response rather than long-term safety or efficacy",
"Background It is unclear whether the carotid intima – media thickness can be influenced by antihypertensive treatment and whether some antihypertensive agents , such as calcium antagonists , may have a greater effect on this parameter than others , such as diuretics . The present paper reports the principal results of the ultrasound sub study of the r and omized , prospect i ve , controlled , Verapamil in Hypertension and Atherosclerosis Study ( VHAS ) . Design and methods In 498 hypertensive patients in eight Italian centres , r and omized to either verapamil ( 240 mg once a day ) or chlorthalidone ( 25 mg once a day ) , a B-mode ultrasound scan was performed according to a st and ardized procedure at baseline and after 3 , 12 , 24 , 36 and 48 months of treatment . The maximum intima – media thicknesses of the far walls of common , bifurcation and internal carotid arteries were measured bilaterally , and the following indices calculated : the mean thickness at the six measured sites , the mean thickness at the common and bifurcation sites and the single maximum thickness . The primary endpoint for treatment efficacy was the slope of the change over 4 years ( rate of change , mm/year ) , corrected by using the initial mean over the six sites ( baseline + 3 months ) as a covariate ( mm/year per mm ) . The patients were also classified into three strata according to their baseline single maximum thickness : those with normal carotid arteries ( single maximum ( 1 mm ) , those with thickened carotid arteries ( single maximum > 1 and ≤ 1.5 mm and those with carotid plaques ( single maximum > 1.5 mm ) . Results Among the 456 patients with satisfactory baseline ultrasound readings , 33 % were classified with normal carotid arteries , 27 % with thickened carotid arteries and 40 % with plaques . In the intention-to-treat population ( 377 patients with ultrasound measurements taken on at least three different occasions over a period of at least 2 years ) , the rate of change in the mean thickness at the six sites measured was rather small ( 0.015 mm/year ) , but significantly ( P the rate of change in the mean thickness at the six sites had a negative slope ( −0.059 mm/year per mm , P in the carotid intima – media thickness in unstratified patients were not different in those treated with verapamil or with chlorthalidone , when changes in the mean thickness of six sites were related to the initial value , the slope of this relationship was significantly different in the two treatment groups ( verapamil −0.082 versus chlorthalidone −0.037 mm/year per mm , P The blood pressure-lowering effect of the two r and omized treatments was similar . Taking fatal and nonfatal , major and minor cardiovascular events together , there were 19 events in the verapamil group and 35 in the chlorthalidone group , with a significantly ( P chlorthalidone ( P verapamil was more effective than the diuretic chlorthalidone in promoting regression of thicker carotid lesions . Changes in the carotid intima – media thickness were small in both groups , and the differences between the changes under the two treatments were consequently small , but the observation that these small differences in carotid wall changes were paralleled by differences in the incidence of cardiovascular events ( better intima – media thickness regression with verapamil paralleled by a lower cardiovascular event rate ) suggests that even small effects on carotid plaques may have clinical and prognostic relevance",
"OBJECTIVE To compare the rate of progression of mean maximum intimal-medial thickness ( IMT ) in carotid arteries , using quantitative B-mode ultrasound imaging , during antihypertensive therapy with isradipine vs hydrochlorothiazide . DESIGN R and omized , double-blind , positive-controlled trial . SETTING Nine medical center clinics . POPULATION A total of 883 patients with baseline mean + /- SD systolic and diastolic blood pressure ( SBP and DBP , respectively ) of 149.7 + /- 16.6 and 96.5 + /- 5.1 mm Hg , age of 58.5 + /- 8.5 years , and maximum IMT of 1.17 + /- 0.20 mm . INTERVENTIONS Twice daily doses of isradipine ( 2.5 - 5.0 mg ) or hydrochlorothiazide ( 12.5 - 25 mg ) . MAIN OUTCOME MEASURE ( PRIMARY END POINT ) : Rate of progression of mean maximum IMT in 12 carotid focal points over 3 years . RESULTS There was no difference in the rate of progression of mean maximum IMT between isradipine and hydrochlorothiazide over 3 years ( P=.68 ) . There was a higher incidence of major vascular events ( eg , myocardial infa rct ion , stroke , congestive heart failure , angina , and sudden death ) in isradipine ( n=25 ; 5.65 % ) vs hydrochlorothiazide ( n=14 ; 3.17 % ) ( P=.07 ) , and a significant increase in nonmajor vascular events and procedures ( eg , transient ischemic attack , dysrhythmia , aortic valve replacement , and femoral popliteal bypass graft ) in isradipine ( n=40 ; 9.05 % ) vs hydrochlorothiazide ( n=23 ; 5.22 % ) ( P=.02 ) . At 6 months , mean DBP decreased by 13.0 mm Hg in both groups , and mean SBP decreased by 19.5 mm Hg in hydrochlorothiazide and 16.0 mm Hg in isradipine ( P=.002 ) ; the difference in SBP between the 2 groups persisted throughout the study but did not explain the increased incidence of vascular events in patients treated with isradipine . CONCLUSION The rate of progression of mean maximum IMT in carotid arteries , the surrogate end point in this study , did not differ between the 2 treatment groups . The increased incidence of vascular events in patients receiving isradipine compared with hydrochlorothiazide is of concern and should be studied further",
"Background Isolated systolic hyprtension occurs in around 8 % of Chinese people aged 60 years or older . In 1988 , the Systolic Hypertension in China ( Syst-China ) Collaborative Group started to investigate whether active treatment could reduce the incidence of stroke and other cardiovascular complications in older patients with isolated systolic hypertension . Methods All patients were initially started on masked placebo . After stratification for centre , sex and previous cardiovascular complications , alternate patients ( n = 1253 ) were assigned nitrendipine at 10–40 mg daily , with the addition of captopril at 12.5–50.0 mg daily or hydrochlorothiazide at 12.5–50.0 mg daily , or both , if a sufficient blood pressure fall was not obtained . In the remaining 1141 control patients , matching placebos were administered similarly . Results At entry , sitting blood pressure averaged 170.5 mmHg systolic and 86.0 mmHg diastolic , age averaged 66.5 years and total serum cholesterol was 5.1 mmol/l . After 2 years of follow-up , sitting systolic and diastolic blood pressures had fallen by 10.9 mmHg and 1.9 mmHg in the placebo group and by 20.0 mmHg and 5.0 mmHg in the active treatment group . The intergroup differences were 9.1 mmHg systolic ( 95 % confidence interval 7.6–10.7 mmHg ) and 3.2 mmHg diastolic ( 95 % confidence interval 2.4–4.0 ) . Active treatment reduced total strokes by 38 % ( from 20.8 to 13.0 endpoints per 1000 patient-years , P = 0.01 ) , all-cause mortality by 39 % ( from 28.4 to 17.4 endpoints per 1000 patient-years , P = 0.003 ) , cardiovascular mortality by 39 % ( from 15.2 to 9.4 endpoints per 1000 patient-years , P = 0.03 ) , stroke mortality by 58 % ( from 6.9 to 2.9 endpoints per 1000 patient-years , P = 0.02 ) , and all fatal and nonfatal cardiovascular endpoints by 37 % ( from 33.3 to 21.4 endpoints per 1000 patient-years , P = 0.004 ) . Conclusions Antihypertensive treatment prevents stroke and other cardiovascular complications in older Chinese patients with isolated systolic hypertension . Treatment of 1000 Chinese patients for 5 years could prevent 55 deaths , 39 strokes or 59 major cardiovascular endpoints ",
"BACKGROUND Isolated systolic hypertension occurs in about 15 % of people aged 60 years or older . In 1989 , the European Working Party on High Blood Pressure in the Elderly investigated whether active treatment could reduce cardiovascular complications of isolated systolic hypertension . Fatal and non-fatal stroke combined was the primary endpoint . METHODS All patients ( > 60 years ) were initially started on masked placebo . At three run-in visits 1 month apart , their average sitting systolic blood pressure was 160 - 219 mm Hg with a diastolic blood pressure lower than 95 mm Hg . After stratification for centre , sex , and previous cardiovascular complications , 4695 patients were r and omly assigned to nitrendipine 10 - 40 mg daily , with the possible addition of enalapril 5 - 20 mg daily and hydrochlorothiazide 12.5 - 25.0 mg daily , or matching placebos . Patients withdrawing from double-blind treatment were still followed up . We compared occurrence of major endpoints by intention to treat . FINDINGS At a median of 2 years ' follow-up , sitting systolic and diastolic blood pressures had fallen by 13 mm Hg and 2 mm Hg in the placebo group ( n = 2297 ) and by 23 mm Hg and 7 mm Hg in the active treatment group ( n = 2398 ) . The between-group differences were systolic 10.1 mm Hg ( 95 % CI 8.8 - 11.4 ) and diastolic , 4.5 mm Hg ( 3.9 - 5.1 ) . Active treatment reduced the total rate of stroke from 13.7 to 7.9 endpoints per 1000 patient-years ( 42 % reduction ; p = 0.003 ) . Non-fatal stroke decreased by 44 % ( p = 0.007 ) . In the active treatment group , all fatal and non-fatal cardiac endpoints , including sudden death , declined by 26 % ( p = 0.03 ) . Non-fatal cardiac endpoints decreased by 33 % ( p = 0.03 ) and all fatal and non-fatal cardiovascular endpoints by 31 % ( p Cardiovascular mortality was slightly lower on active treatment ( -27 % , p = 0.07 ) , but all-cause mortality was not influenced ( -14 % ; p = 0.22 ) . INTERPRETATION Among elderly patients with isolated systolic hypertension , antihypertensive drug treatment starting with nitrendipine reduces the rate of cardiovascular complications . Treatment of 1000 patients for 5 years with this type of regimen may prevent 29 strokes or 53 major cardiovascular endpoints"
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41172d14-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES A systematic review was conducted to determine whether the etch- and -rinse or self-etching mode is the best protocol for dentin and enamel adhesion by universal adhesives . DATA This report followed the PRISMA Statement . A total of 10 articles were included in the meta- analysis . SOURCES Two review ers performed a literature search up to October 2014 in eight data bases : PubMed , Web of Science , Scopus , BBO , SciELO , LILACS , IBECS and The Cochrane Library . STUDY SELECTION In vitro studies evaluating the bond strength of universal adhesives to dentin and /or enamel by the etch- and -rinse and self-etch strategies were eligible to be selected . Statistical analyses were conducted using RevMan 5.1 ( The Cochrane Collaboration , Copenhagen , Denmark ) . A global comparison was performed with r and om-effects models at a significance level of p analysis of dentin micro-tensile bond strength showed no statistically significant difference between the etch- and -rinse and self-etch strategies for mild universal adhesives ( p≥0.05 ) . However , for the ultra-mild All-Bond Universal adhesive , the etch- and -rinse strategy was significantly different than the self-etch mode in terms of dentin micro-tensile bond strength , as well as in the global analysis of enamel micro-tensile and micro-shear bond strength ( p≤0.05 ) . CONCLUSIONS The enamel bond strength of universal adhesives is improved with prior phosphoric acid etching . However , this effect was not evident for dentin with the use of mild universal adhesives with the etch- and -rinse strategy . CLINICAL SIGNIFICANCE Selective enamel etching prior to the application of a mild universal adhesive is an advisable strategy for optimizing bonding
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"PURPOSE To compare microtensile bond strength ( μTBS ) and interfacial morphology of a new one-step multimode adhesive with a two-step self-etching adhesive and two etch- and -rinse adhesives systems on enamel . MATERIAL S AND METHODS Thirty human third molars were sectioned to obtain two enamel fragments . For μTBS , 48 enamel surfaces were ground using 600-grit SiC paper and r and omly assigned into 6 groups ( n = 8) : nonetched Scotchbond Universal [ SBU ] ; etched SBU [ SBU-et ] ; non-etched Clearfil SE Bond [ CSE ] ; etched CSE [ CSE-et ] ; Scotchbond Multi- PURPOSE [ SBMP ] ; Excite [ EX ] . The etched specimens were conditioned with 37 % phosphoric acid for 30 s , each adhesive system was applied according to manufacturers ' instructions , and composite resin blocks ( Filtek Supreme Plus , 3 M ESPE ) were incrementally built up . Specimens were sectioned into beams with a cross-sectional area of 0.8-mm2 and tested under tension ( 1 mm/min ) . The data were analyzed with oneway ANOVA and Fisher 's PLSD ( α = 0.05 ) . For interface analysis , two sample s from each group were embedded in epoxy resin , polished , and then observed using scanning electron microscopy ( SEM ) . RESULTS The μTBS values ( in MPa ) and the st and ard deviations were : SBU = 27.4 ( 8.5 ) ; SBU-et = 33.6 ( 9.3 ) ; CSE = 28.5 ( 8.3 ) ; CSE-et = 34.2 ( 9.0 ) ; SBMP = 30.4 ( 11.0 ) ; EX = 23.3 ( 8.2 ) . CSE-et and SBU-et presented the highest bond strength values , followed by SBMP , CSE , and SBU which did not differ significantly from each other . EX showed the statistically significantly lowest bond strength values . SEM images of interfaces from etched sample s showed long adhesive-resin tags penetrating into demineralized enamel . CONCLUSIONS Preliminary etching of enamel significantly increased bond strength for the new one-step multimode adhesive SBU and two-step self-etching adhesive CSE",
"OBJECTIVE To evaluate the microtensile bond strengths ( μTBS ) and nanoleakage ( NL ) of three universal or multi-mode adhesives , applied with increasing solvent evaporation times . METHODS One-hundred and forty caries-free extracted third molars were divided into 20 groups for bond strength testing , according to three factors : ( 1 ) Adhesive - All-Bond Universal ( ABU , Bisco , Inc. ) , Prime&Bond Elect ( PBE , Dentsply ) , and Scotchbond Universal Adhesive ( SBU , 3 M ESPE ) ; ( 2 ) Bonding strategy - self-etch ( SE ) or etch- and -rinse ( ER ) ; and ( 3 ) Adhesive solvent evaporation time - 5s , 15s , and 25s . Two extra groups were prepared with ABU because the respective manufacturer recommends a solvent evaporation time of 10s . After restorations were constructed , specimens were stored in water ( 37 ° C/24h ) . Resin-dentin beams ( 0.8mm(2 ) ) were tested at 0.5mm/min ( μTBS ) . For NL , forty extracted molars were r and omly assigned to each of the 20 groups . Dentin disks were restored , immersed in ammoniacal silver nitrate , sectioned and processed for evaluation under a FESEM in backscattered mode . Data from μTBS were analyzed using two-way ANOVA ( adhesive vs. drying time ) for each strategy , and Tukey 's test ( α=0.05 ) . NL data were computed with non-parametric tests ( Kruskal-Wallis and Mann-Whitney tests , α=0.05 ) . RESULTS Increasing solvent evaporation time from 5s to 25s result ed in statistically higher mean μTBS for all adhesives when used in ER mode . Regarding NL , ER result ed in greater NL than SE for each of the evaporation times regardless of the adhesive used . A solvent evaporation time of 25s result ed in the lowest NL for SBU-ER . SIGNIFICANCE Residual water and /or solvent may compromise the performance of universal adhesives , which may be improved with extended evaporation times",
"UNLABELLED The self-etch approach provides dentists with a generation of user-friendly and less technique-sensitive adhesives . Nevertheless , some concern has been raised regarding their bonding effectiveness to enamel , in particular when so-called ' mild ' self-etch adhesives are employed . OBJECTIVES The purpose of this study was to test the hypothesis that the two-step self-etch adhesive Clearfil SE Bond ( C-SE ; Kuraray , Osaka , Japan ) bonds equally effective to enamel/dentin either with or without prior etching with phosphoric acid . METHODS Bur-cut enamel/dentin surfaces prepared from human molars were partially split in two halves by cutting a shallow groove . One half was first etched with 40 % phosphoric acid ( K-etchant ) , while protecting the other half by holding a razor blade in the groove . Next , C-SE was applied strictly following the manufacturer 's instructions , after which the surface was built up using Z100 ( 3 M Espe ) . After 24-h water storage , micro-specimens were prepared with the interface circularly constricted using a Micro-Specimen Former , prior to micro-tensile bond strength ( MPa ) measurement . In addition , interfaces of C-SE with enamel/dentin prepared with and without beforeh and acid etching were examined by Feg-SEM and TEM . RESULTS Beforeh and etching significantly increased the bonding effectiveness of C-SE to enamel . A clearly more micro-retentive surface was revealed by TEM and Feg-SEM when enamel was etched . Phosphoric-acid etching prior to C-SE application on dentin significantly decreased the muTBS to dentin . TEM provided indications of a low- quality hybrid layer after beforeh and phosphoric-acid etching . CONCLUSION Using C-SE , additional etching with phosphoric acid to improve bonding effectiveness should be limited to enamel",
"This study examined the effect of phosphoric acid ( PA ) etching on the bond strength and acid-base resistant zone ( ABRZ ) formation of a two-step self-etching adhesive ( SEA ) system to enamel . An etch- and -rinse adhesive ( EAR ) system Single Bond ( SB ) and a two-step SEA system Clearfil SE Bond ( SE ) were used . Human teeth were r and omly divided into four groups according to different adhesive treatments : 1 ) SB ; 2 ) SE ; 3 ) 35 % PA etching→SE primer→SE adhesive ( PA/SEp+a ) ; ( 4 ) 35 % PA etching→SE adhesive ( PA/SEa ) . Microshear bond strength to enamel was measured and then statistically analyzed using one-way analysis of variance and the Tukey honestly significant difference test . The failure mode was recorded and analyzed by χ ( 2 ) test . The etching pattern of the enamel surface was observed with scanning electron microscope ( SEM ) . The bonded interface was exposed to a demineralizing solution ( pH=4.5 ) for 4.5 hours and then 5 % sodium hypochlorite with ultrasonication for 30 minutes . After argon-ion etching , the interfacial ultrastructure was observed using SEM . The microshear bond strength to enamel of the SE group was significantly lower ( p The ABRZ was detected in all the groups . In morphological observation , the ABRZ in the three PA-etched groups were obviously thicker compared with the SE group with an irregular wave-shaped edge",
"OBJECTIVE Bond strengths of composite resin to enamel using self-etch adhesive ( SEA ) Clearfil SE bond system on intact enamel and enamel pre-etched with phosphoric acid were compared . The objective was to determine if the pre-etching would increase the bond strengths of the SEA systems to intact enamel and to evaluate the effect of pre-etching on bond formation of self-etch adhesives on intact enamel . MATERIAL S AND METHOD Labial surfaces of 40 caries free permanent upper central and lateral incisors were cleaned , sectioned of their roots . All specimens were mounted on acrylic block and divided r and omly into four groups . In two groups the application of self-etch adhesive , Clearfil SE bond was carried as per manufacturer 's instructions , composite cylinders were built , whereas in the other two groups , 37 % phosphoric acid etching was done before the application of self-etching adhesives . Then the resin tags were analyzed using scanning electron microscope and shear bond strength was measured using Instron universal testing machine . RESULTS When phosphoric acid was used , there was significant increase in the depth of penetration of resin tags and in the Shear Bond Strength of composite to enamel . CONCLUSION The results indicate that out of both treatment groups , pre-etching the intact enamel with 37 % phosphoric acid result ed in formation of longer resin tags and higher depth of penetration of resin tags of the Clearfil SE bond , and attaining higher bond strength of the Clearfil SE bond to intact enamel",
"PURPOSE To evaluate the 18-month clinical performance of a multimode adhesive ( Scotchbond Universal Adhesive , SU , 3 M ESPE , St Paul , MN , USA ) in noncarious cervical lesions ( NCCLs ) using two evaluation criteria . MATERIAL S AND METHODS Thirty-nine patients participated in this study . Two-hundred restorations were assigned to four groups : ERm , etch- and -rinse + moist dentin ; ERd , etch- and -rinse + dry dentin ; Set , selective enamel etching ; and SE , self-etch . The composite resin , Filtek Supreme Ultra ( 3 M ESPE ) , was placed incrementally . The restorations were evaluated at baseline , and at 18 months , using both the World Dental Federation ( FDI ) and the United States Public Health Service ( USPHS ) criteria . Statistical analyses were performed using Friedman repeated- measures analysis of variance by rank and McNemar test for significance in each pair ( α=0.05 ) . RESULTS Five restorations ( SE : 3 ; Set : 1 ; and ERm : 1 ) were lost after 18 months ( p>0.05 for either criteria ) . Marginal staining occurred in four and 10 % of the restorations evaluated ( p>0.05 ) , respectively , for USPHS and FDI criteria . Nine restorations were scored as bravo for marginal adaptation using the USPHS criteria and 38 % , 40 % , 36 % , and 44 % for groups ERm , ERd , Set , and SE , respectively , when the FDI criteria were applied ( p>0.05 ) . However , when semiquantitative scores ( or SQUACE ) for marginal adaptation were used , SE result ed in a significantly greater number of restorations , with more than 30 % of the total length of the interface showing marginal discrepancy ( 28 % ) in comparison with the other groups ( 8 % , 6 % , and 8 % , respectively , for ERm , ERd , and Set ) . CONCLUSIONS The clinical retention of the multimode adhesive at 18 months does not depend on the bonding strategy . The only differences between strategies were found for the parameter marginal adaptation , for which the FDI criteria were more sensitive than the USPHS criteria",
"PURPOSE The aim of this study was to investigate the intra- and intertooth microtensile bond strength variability of two adhesive systems applied to dentin . MATERIAL S AND METHODS Twenty human third molars were ground to expose a flat dentin surface . Two adhesive systems ( Single Bond and One Step ) were applied according to the manufacturers ' instructions and composite resin crowns were constructed incrementally . After 24 h in distilled water at 37 degrees C , each tooth was longitudinally sectioned in both \" x \" and \" y \" directions under 300 rpm to obtain sticks with a cross-sectional area of 0.8 mm2 . The sticks from each tooth were tested at a crosshead speed of 0.5 mm/min . The fracture pattern of each stick was microscopically analyzed after debonding ( 400X ) . A mixed model with adhesive as a fixed variable , tooth as a r and om variable , and bonded area included as a covariate , was employed for the data treatment . In this model , all observations have the same variance , which is the sum of two components : the variance of the r and om effect ( intertooth ) and the variance of the errors ( intratooth ) . RESULTS The intratooth variability was greater than the intertooth variability . CONCLUSION The intratooth variability is higher than the intertooth variability . Sticks from the same tooth can not be considered as an experimental unit , since it does not fulfill all ANOVA requirements",
"BACKGROUND The author compared the clinical performance of a two-step self-etching adhesive system and a one-step self-etching adhesive system over one year . METHODS Thirty-five patients with noncarious cervical lesions were enrolled in the study . The author restored 163 lesions using a two-step ( Clearfil Protect Bond , Kuraray , Osaka , Japan ) or a one-step ( Xeno III , Dentsply/DeTrey , Konstanz , Germany ) self-etching adhesive system . Enamel margins were not beveled , and no mechanical retentions were placed . The author evaluted the restorations at baseline and at three , six , nine and 12 months after placement using modified Ryge criteria for color-matching ability , marginal discoloration , marginal adaptation , initial caries formation , anatomical form , postoperative sensitivity and retention loss . RESULTS The author assessed the changes in the parameters using the Cochran Q test and the McNemar test at a significance level of .05 . At one year , the retention rates for the restorations in the two-step group were 100 percent ; they were 96 percent for the restorations in the one-step group . Of the retained 75 restorations from the one-step group , two had marginal discoloration and slight anatomical form problems . In both groups , color-matching ability and postoperative sensitivity remained excellent . CONCLUSION The performance of both self-etching adhesive systems was excellent during this one-year clinical trial . However , the two-step system exhibited slightly better retention than the one-step system . CLINICAL IMPLICATION S The one- and two-step self-etching adhesive systems evaluated in this study provided excellent clinical retention in noncarious lesions without mechanical retention",
"OBJECTIVES The aim was to determine the effect of blood contamination and haemostatic agent application on the shear bond strength ( SBS ) of different adhesives to dentin . MATERIAL S AND METHODS Seventy-two extracted human molars were used in this study . Teeth were mounted acrylic in moulds . Mesial and distal surfaces were removed to obtain flat dentin surfaces ( n=144 ) and grinded with a 600 grit s and paper . The sample s were r and omly divided into three main groups ( N=48 ) based on the adhesive system and application procedures . GROUP 1 : No contamination ( control ) , GROUP 2 : Blood contamination , GROUP 3 : Blood Contamination+Haemostatic agent application . Each group was further divided into four subgroups : SUBGROUP I : Single Bond 2 ( etch- and -rinse ) Subgroup II : Clearfil SE Bond ( two-step self-etch ) Subgroup III : Single Bond Universal ( multimode , etch- and -rinse ) subgroup IV : Single Bond Universal ( multimode , all-in-one self-etch ) ( n=12 ) . Resin cylinders ( Filtek Z550 ) were bonded to the dentin surfaces according to the manufacturers ' instructions . A shear load was applied to the specimens using universal testing machine at a cross-head speed of 0.5 mm/min until failure . Data were analyzed statistically ( p mean SBS values ( p>0.05 ) . CONCLUSION When blood contamination is inevitable two step self- etching adhesive systems may be the choice of adhesive system in terms of shear bond strength",
"PURPOSE To investigate the effect of phosphoric acid etching prior to the application of self-etching primer on the adhesion of resin composite to tooth substrates . MATERIAL S AND METHODS Bovine teeth were r and omly divided in four groups of 20 sample s each . Tooth surface conditions were as follows : Group 1 : enamel ground with 600-grit SiC paper ; Group 2 : ground enamel was etched with 35 % phosphoric acid gel for 15 seconds , water-rinsed and completely dried ; Group 3 : ground dentin ; Group 4 : dentin etched using the same method as Group 2 . The sample s in each group were divided in two subgroups of 10 each . UniFil Bond ( UB ) and Clearfil SE Bond ( SE ) were applied as adhesive systems with self-etching primers , and a layer of resin composite ( AP-X ) was placed and light-cured for 40 seconds . The tensile bond strengths ( TBS ) were measured and the resin-tooth interfaces were observed with scanning electron microscopy . RESULTS The mean TBS values were 11.2 MPa ( Group 1-UB ) , 14.3 MPa ( Group 1-SE ) , 16.3 MPa ( Group 2-UB ) , 20.5 MPa ( Group 2-SE ) , 13.4 MPa ( Group 3-UB ) , 16.7 MPa ( Group 3-SE ) , 9.3 MPa ( Group 4-UB ) and 12.6 MPa ( Group 4-SE ) . Two-way ANOVA and Scheffe 's F test showed that the enamel etching significantly increased the TBS values but dentin etching significantly decreased the TBS values",
"The purpose of this study was to evaluate the influence of intrapulpal pressure and dentin depth on bond strengths of an etch- and -rinse and a self-etching bonding agent to dentin in vitro and in vivo . Twenty-four pairs of premolars were r and omly divided into four groups ( n = 6 ) according to the dentin bonding agent , Single Bond and Clearfil SE Bond , and intrapulpal pressure , None or positive . Each tooth of the pair was further design ated to be treated in vivo or in vitro . The intrapulpal pressure was controlled in vivo by the delivery of local anesthetics containing or not a vasoconstrictor , while in vitro , it was achieved by keeping the teeth under hydrostatic pressure . Class I cavities were prepared and the dentin bonding agents were applied followed by incremental resin restoration . For the teeth treated in vitro , the same restorative procedures were performed after a 6 month-storage period . Beams with 1 mm(2 ) cross-sectional area were prepared and microtensile tested . Clearfil SE Bond was not influenced by any of the variables of the study , while bond strengths produced in vitro were significantly higher for Single Bond . Overall , lower bond strengths were produced in deep dentin , which reached statistical significance when Single Bond was applied under physiological or simulated intrapulpal pressure . In conclusion , in vitro bonding may overestimate the immediate adhesive performance of more technique-sensitive dentin bonding systems . The impact of intrapulpal pressure on bond strength seems to be more adhesive dependent than dentin morphological characteristics related to depth",
"OBJECTIVES The purpose of this study was to evaluate the effects of load cycling on nanoleakage of occlusal flat surface or cervical restorations bonded with three self-etching priming systems and a single bottle system . METHODS The dentin bonding systems used in this study were Clearfil SE Bond , Unifil Bond , Prompt L-Pop and Single Bond . Flat occlusal dentin surfaces and cervical cavities from extracted human molars were bonded with one of the dentin bonding systems . After load cycling of 90N for 5000 cycles , sample s were immersed in a 50 % w/v solution of silver nitrate for 24h , and exposed to photodeveloping solution for 8h . Specimens were sectioned , mounted on stubs , carbon-coated and observed in a Field Emission-SEM using backscattered electron mode . One-way ANOVA was used for statistical analysis of the leakage scores . RESULTS FE-SEM images showed that sample s subjected to load cycling had leakage patterns similar to non-load-cycled sample s for all dentin bonding systems . Load cycling did not affect leakage lengths in any system . Prompt L-Pop had greater silver deposition and leakage score than the other systems . SIGNIFICANCE The dentin bonding systems tested were unable to prevent nanoleakage , and the extent of nanoleakage was not increased by load cycling",
"OBJECTIVES The aim of this study was to evaluate the bonding of four commercially available adhesive systems to ground and intact enamel surfaces . METHODS Extracted human teeth were used to measure the microtensile bond strength to enamel and a field-emission scanning electron microscopy ( FE-SEM ) was used to observe the bonded interface and the effect of the surface conditioning of each material . Intact buccal enamel surfaces were cleansed with tooth paste using a rotary dental brush , and the ground enamel surfaces were prepared by reducing approximately 0.5 mm from the buccal enamel surfaces using a high-speed diamond bur . One-Step ( OS , Bisco ) , Single Bond ( SB , 3 M ) , Clearfil Liner Bond II ( LBII , Kuraray ) , and Tokuso Mac Bond II ( MBII , Tokuso ) were evaluated for their ability to bond to enamel . RESULTS There was no significant difference in bond strengths between the material s when they were applied to ground enamel surfaces ( p > 0.05 ) . However , the bond strengths of the self-etching systems , LBII and MBII , had significantly lower bond strengths to intact enamel than the bonding systems OS and SB using phosphoric acid etching ( p penetration of bonding resin when applied to intact enamel surfaces . CONCLUSIONS Phosphoric acid etching produced good resin adhesion to ground and intact enamel . The self-etching/self-priming systems also produced good adhesion to ground enamel , but had lower bond strengths to intact enamel"
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41172d5a-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Circumferential pulmonary vein ablation ( CPVA ) has become common therapy for atrial fibrillation ( AF ) , but results of large r and omized controlled trials comparing this procedure with antiarrhythmic drug therapy ( ADT ) have not been published to date . We conducted a systematic literature review to assess whether CPVA is superior to ADT for the management of AF . METHODS We search ed PubMed , EMBASE , and the Cochrane Central Register of Controlled Trials for relevant r and omized controlled trials . Data were abstract ed to construct a 2 x 2 table for each trial . Recurrence of any atrial tachyarrhythmia ( AT ) was considered the primary end point of the trials . The estimate and confidence interval for the pooled risk ratio of AT recurrence-free survival in the CPVA group vs the ADT group were obtained using the r and om-effects model . RESULTS Four trials qualified for the meta- analysis . In total , 162 of 214 patients ( 75.7 % ) in the CPVA group had AT recurrence-free survival vs 41 of 218 patients ( 18.8 % ) in the ADT group . The r and om-effects pooled risk ratio for AT recurrence-free survival was 3.73 ( 95 % confidence interval , 2.47 - 5.63 ) . In addition , fewer adverse events were reported in the CPVA group compared with that in the ADT group . CONCLUSIONS We observed statistically significantly better AT recurrence-free survival with CPVA than with ADT . These results highlight the need for larger trials to determine the appropriate role for CPVA in the management of AF . Ongoing clinical trials may provide further guidance on these treatment options for AF
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[
"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 —Circumferential pulmonary vein ablation ( CPVA ) is effective in curing atrial fibrillation ( AF ) , but new-onset left atrial tachycardia ( AT ) is a potential complication . We evaluated whether a modified CPVA approach including additional ablation lines on posterior wall and the mitral isthmus would reduce the incidence of AT after PV ablation . Methods and Results —A total of 560 patients ( 291 men , 52 % ; age , 56.5±7.3 years ) entered the study ; 280 were r and omized to CPVA alone ( group 1 ) and 280 to modified CPVA ( group 2 ) . The primary end point was freedom from AT after the procedure . In group 1 , 28 patients ( 10 % ) experienced new-onset AT , and 41 ( 14.3 % ) experienced recurrent AF . In group 2 , 11 patients ( 3.9 % ) experienced AT , and 36 ( 12.9 % ) had recurrent AF . Group 1 was more likely to experience AT than group 2 ( P=0.005 ) . Freedom from AF after ablation was similar in both groups ( P=0.57 ) . Among those in group 1 , gap-related macroreentrant AT was documented in 23 of the 28 patients ( 82 % ) , and focal AT was found in 5 ( 18 % ) . In group 2 , gap-related macroreentrant AT was found in 8 of the 11 patients ( 73 % ) , and focal AT was seen in 3 ( 27 % ) . Two patients in group 1 and 1 patient in group 2 had both AT and AF . The strongest predictor of AT was the presence of gaps ( P —Modified CPVA is as effective as CPVA in preventing AF but is associated with a lower risk of developing incessant AT ",
"Background —Segmental ostial catheter ablation ( SOCA ) to isolate the pulmonary veins ( PVs ) and left atrial catheter ablation ( LACA ) to encircle the PVs both may eliminate paroxysmal atrial fibrillation ( PAF ) . The relative efficacy of these 2 techniques has not been directly compared . Methods and Results —Of 80 consecutive patients with symptomatic PAF ( age , 52±10 years ) , 40 patients underwent PV isolation by SOCA and 40 patients underwent LACA to encircle the PVs . During SOCA , ostial PV potentials recorded with a ring catheter were targeted . LACA was performed by encircling the left- and right-sided PVs 1 to 2 cm from the ostia and was guided by an electroanatomic mapping system ; ablation lines also were created in the mitral isthmus and posterior left atrium . The mean procedure and fluoroscopy times were 156±45 and 50±17 minutes for SOCA and 149±33 and 39±12 minutes for LACA , respectively . At 6 months , 67 % of patients who underwent SOCA and 88 % of patients who underwent LACA were free of symptomatic PAF when not taking antiarrhythmic drug therapy ( P = 0.02 ) . Among the variables of age , sex , duration and frequency of PAF , ejection fraction , left atrial size , structural heart disease , and the ablation technique , only an increased left atrial size and the SOCA technique were independent predictors of recurrent PAF . The only complication was left atrial flutter in a patient who underwent LACA . Conclusions —In patients undergoing catheter ablation for PAF , LACA to encircle the PVs is more effective than SOCA",
"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 We conducted a r and omized , controlled trial of circumferential pulmonary-vein ablation for the treatment of chronic atrial fibrillation . METHODS A total of 146 patients with a mean ( + /-SD ) age of 57+/-9 years who had chronic atrial fibrillation were r and omly assigned to receive amiodarone and undergo two cardioversions during the first three months alone ( the control group ) or in combination with circumferential pulmonary-vein ablation . Cardiac rhythm was assessed with daily telephonic transmissions for one year . The left atrial diameter and the severity of symptoms were assessed at 12 months . RESULTS Among the 77 patients assigned to undergo circumferential pulmonary-vein ablation , ablation was repeated because of recurrent atrial fibrillation in 26 percent of patients and atypical atrial flutter in 6 percent . An intention-to-treat analysis showed that 74 percent of patients in the ablation group and 58 percent of those in the control group were free of recurrent atrial fibrillation or flutter without antiarrhythmic-drug therapy at one year ( P=0.05 ) . Among the 69 patients in the control group , 53 ( 77 percent ) crossed over to undergo circumferential pulmonary-vein ablation for recurrent atrial fibrillation by one year and only 3 ( 4 percent ) were in sinus rhythm without antiarrhythmic-drug therapy or ablation . There were significant decreases in the left atrial diameter ( 12+/-11 percent , P symptom severity score ( 59+/-21 percent , P Sinus rhythm can be maintained long term in the majority of patients with chronic atrial fibrillation by means of circumferential pulmonary-vein ablation independently of the effects of antiarrhythmic-drug therapy , cardioversion , or both . The maintenance of sinus rhythm is associated with a significant decrease in both the severity of symptoms and the left atrial diameter",
"Background —The objective of this study was to assess the incidence and impact of asymptomatic arrhythmia in patients with highly symptomatic atrial fibrillation ( AF ) who qualified for radiofrequency ( RF ) catheter ablation . Methods and Results —In this prospect i ve study , 114 patients with at least 3 documented AF episodes together with corresponding symptoms and an ineffective trial of at least 1 antiarrhythmic drug were selected for RF ablation . With the use of CARTO , circumferential lesions around the pulmonary veins and linear lesions at the roof of the left atrium and along the left atrial isthmus were placed . A continuous , 7-day , Holter session was recorded before ablation , right after ablation , and after 3 , 6 , and 12 months of follow-up . During each 7-day Holter monitoring , the patients recorded quality and duration of any complaints by using a detailed symptom log . More than 70 000 hours of ECG recording were analyzed . In the 7-day Holter records before ablation , 92 of 114 patients ( 81 % ) had documented AF episodes . All episodes were symptomatic in 35 patients ( 38 % ) . In 52 patients ( 57 % ) , both symptomatic and asymptomatic episodes were recorded , whereas in 5 patients ( 5 % ) , all documented AF episodes were asymptomatic . After ablation , the percentage of patients with only asymptomatic AF recurrences increased to 37 % ( P asymptomatic AF . Conclusions —Even in patients presenting with highly symptomatic AF , asymptomatic episodes may occur and significantly increase after catheter ablation . A symptom-only – based follow-up would substantially overestimate the success rate . Objective measures such as long-term Holter monitoring are needed to identify asymptomatic AF recurrences after ablation",
"OBJECTIVES We tested the hypothesis that the response to flecainide infusion can identify patients with atrial fibrillation ( AF ) in whom the hybrid pharmacologic and ablation therapy reduces the recurrences of AF . BACKGROUND Infusion of class IC anti-arrhythmic drugs may promote transformation of AF into atrial flutter . Catheter ablation of atrial flutter has been demonstrated to be highly effective in preventing recurrences of atrial flutter . METHODS Seventy-one consecutive patients with paroxysmal or chronic AF , in whom flecainide infusion ( 2 mg/kg body weight , intravenously ) determined the transformation of AF into common atrial flutter ( positive response ) , were r and omized to receive one of the following treatments : oral pharmacologic treatment with flecainide ( group A , n = 23 ) ; the hybrid treatment ( catheter ablation of the inferior vena cava-tricuspid annulus isthmus , plus oral flecainide ) ( group B , n = 24 ) ; or catheter ablation of the isthmus only ( group C , n = 24 ) . Thirty-seven patients with a negative response to flecainide , who chose to be su bmi tted to the hybrid treatment , were selected as the control group ( group D ) . RESULTS During a mean follow-up period of 24 + /- 7.2 months , the recurrences of AF and atrial flutter in group B ( 42 % ) were significantly lower than those in group A ( 78 % , p recurrences of both AF and atrial flutter in patients with class IC atrial flutter . Moreover , the early response to flecainide is safe and reliable in identifying patients who may benefit from this therapy",
"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",
"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 )",
"BACKGROUND Maintenance of sinus rhythm is the main therapeutic goal in patients with atrial fibrillation . However , recurrences of atrial fibrillation and side effects of antiarrhythmic drugs offset the benefits of sinus rhythm . We hypothesized that ventricular rate control is not inferior to the maintenance of sinus rhythm for the treatment of atrial fibrillation . METHODS We r and omly assigned 522 patients who had persistent atrial fibrillation after a previous electrical cardioversion to receive treatment aim ed at rate control or rhythm control . Patients in the rate-control group received oral anticoagulant drugs and rate-slowing medication . Patients in the rhythm-control group underwent serial cardioversions and received antiarrhythmic drugs and oral anticoagulant drugs . The end point was a composite of death from cardiovascular causes , heart failure , thromboembolic complications , bleeding , implantation of a pacemaker , and severe adverse effects of drugs . RESULTS After a mean ( + /-SD ) of 2.3+/-0.6 years , 39 percent of the 266 patients in the rhythm-control group had sinus rhythm , as compared with 10 percent of the 256 patients in the rate-control group . The primary end point occurred in 44 patients ( 17.2 percent ) in the rate-control group and in 60 ( 22.6 percent ) in the rhythm-control group . The 90 percent ( two-sided ) upper boundary of the absolute difference in the primary end point was 0.4 percent ( the prespecified criterion for noninferiority was 10 percent or less ) . The distribution of the various components of the primary end point was similar in the rate-control and rhythm-control groups . CONCLUSIONS Rate control is not inferior to rhythm control for the prevention of death and morbidity from cardiovascular causes and may be appropriate therapy in patients with a recurrence of persistent atrial fibrillation after electrical cardioversion",
"OBJECTIVE The objective of this prespecified sub study of the AFFIRM study , in which no differences in survival or event rates were found in patients with atrial fibrillation ( AF ) r and omized to either rate control or rhythm control , was to test the None hypothesis that quality of life ( QoL ) is equal with rate- versus rhythm-control treatment strategies in AF . METHODS Fifty-six ( 25 % ) of AFFIRM sites were r and omly selected to recruit AFFIRM patients for the QoL sub study . Instruments used in the QoL assessment were ( 1 ) Perceived Health ; ( 2 ) the Cantril Ladder of Life ; ( 3 ) the Short Form 36 survey ; ( 4 ) the QoL Index ; and ( 5 ) the Symptom Checklist : Frequency and Severity . Data were collected at baseline , 2 months , 12 months , and annually ; data are reported through 4 years of follow-up . RESULTS Baseline characteristics of the AFFIRM QoL patients ( n = 716 ) were generally similar to those of the rest of AFFIRM patients . Quality -of-life scores were similar in rate- and rhythm-control assignment groups at all time points . Quality -of-life scores were similar whether the actual rhythm was sinus or AF . Scores increased from baseline to subsequent time points similarly for both groups ; these improvements were not additive over time . CONCLUSIONS Quality of life was comparable between rate- and rhythm-control treatment strategies . In addition , QoL was similar with sinus rhythm versus AF . Attempts to improve QoL by restoring sinus rhythm will usually be unsuccessful"
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41172d96-06ff-11f0-808a-c43d1ab1c353
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Vitamin D deficiency is common and there exists a huge gap between recommended dietary vitamin D intakes and the poor vitamin D supply in the general population . While vitamin D is important for musculoskeletal health , there are accumulating data suggesting that vitamin D may also be important for fertility , pregnancy outcomes and lactation . Significant changes in vitamin D metabolism during pregnancy such as increased production of the " active vitamin D hormone " calcitriol support the important role of vitamin D in this setting . Observational studies show that vitamin D deficiency is a risk marker for reduced fertility and various adverse pregnancy outcomes and is associated with a low vitamin D content of breast milk . Meta-analyses of r and omized controlled trials ( RCTs ) document that physiological vitamin D supplementation during pregnancy is safe and improves vitamin D and calcium status , thereby protecting skeletal health . Although certain RCTs and /or meta-analyses reported some other beneficial effects , it is still not clear whether vitamin D supplementation improves fertility or decreases the risk of adverse pregnancy outcomes such as low birth weight , pre-eclampsia and neonatal mortality , or reduces wheeze/asthma in the infants . Nevertheless , vitamin D supplementation in pregnant women is frequently required to achieve a sufficient vitamin D status as recommended by nutritional vitamin D guidelines . In this review , we provide an overview of systematic review s , meta-analyses and large trials reporting clinical data on the role of vitamin D for fertility , pregnancy and lactation
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"The German Nutrition Society raised in 2012 the recommended daily vitamin D intake from 200 to 800 international units ( IU ) to achieve 25-hydroxyvitamin D ( 25(OH)D ) levels of at least 50 nmol/L , even when endogenous vitamin D synthesis is minimal such as in winter . We aim ed to evaluate this recommendation in women of childbearing age . This is a single-center , r and omized , open trial conducted from 8 January to 9 May 2016 in Esslingen , Germany . We r and omized 201 apparently healthy women to receive for 8 weeks a daily multimicronutrient supplement containing either 200 IU ( n = 100 ) or 800 IU vitamin D3 ( n = 101 ) . Primary outcome measure was serum 25(OH)D. 196 participants completed the trial . Increases in 25(OH)D ( median with interquartile range ) from baseline to study end were 13.2 ( 5.9 to 20.7 ) nmol/L in the 200 IU group , and 35.8 ( 18.2 to 52.8 ) nmol/L in the 800 IU group ( p levels of ≥50 nmol/L were present in 70.4 % of the 200 IU group and in 99 % of the 800 IU group . Participants on hormonal contraceptives had higher baseline levels and a stronger increase in 25(OH)D. In conclusion , daily supplementation of 800 IU vitamin D3 during wintertime in Germany is sufficient to achieve a 25(OH)D level of at least 50 nmol/L in almost all women of childbearing age , whereas 200 IU are insufficient",
"Highlights • Pregnancy vitamin D and cord blood DNA methylation compared in 1416 infants.• Associations tested in two large prospect i ve cohort studies , MoBa and ALSPAC.• Similarly for offspring health outcomes and vitamin D , no convincing associations",
"Introduction Preeclampsia is a pregnancy-specific syndrome . One of the hypotheses concerning the etiology of preeclampsia is vitamin D deficiency during pregnancy . Method and Material s The present study is a r and omized controlled clinical trial which aims to determine the effect of vitamin D supplement on reducing the probability of recurrent preeclampsia . 72 patients were placed in control group while 70 patients were r and omized to the intervention group . The intervention group received a 50000 IU pearl vitamin D3 once every two weeks . The control group was administered placebo . Vitamin D or placebo was given until the 36th week of pregnancy . Results The patients in intervention group have significantly lower ( P value = 0.036 ) probability of preeclampsia than patients in the control group . The risk of preeclampsia for the control group was 1.94 times higher than that for the intervention group ( 95 % CI 1.02 , 3.71 ) . Conclusion The intended intervention ( i.e. , prescription of vitamin D ) has a protective effect against recurrent preeclampsia . Vitamin D supplementation therapy in pregnancy could help in reducing the incidence of gestational hypertension/preeclampsia . Registration This study has been registered in Iranian Registry of Clinical Trials ( I RCT ) site with ID number I RCT 2017010131695N1",
"Summary On September 29 , 2011 , acknowledged experts in the field of vitamin D , mainly European , were brought together in order to discuss the recent scientific advances in relation to vitamin D : the current requirements and associations with various health outcomes . In this article , the discussion s result ing from the meeting are summarized . Introduction Several groups at risk for developing vitamin D insufficiency have been identified . Accordingly , review s indicate that a significant percentage of the population worldwide have serum 25-hydroxyvitamin D levels below 50 nmol/l . In addition to the role of vitamin D in bone health , recent studies suggest that it may play a pivotal role in other systems , e.g. , the cardiovascular system , pancreas , muscle , immune system and brain . Most evidence , however , is obtained from observational studies and yet inconclusive . Methods To exchange and broaden knowledge on the requirements for vitamin D and its effect on various health outcomes , a workshop entitled “ Vitamin D Expert Meeting : Do we get enough ? ” , was organized . Results Despite low vitamin D levels worldwide , consensus on the definition of deficiency is not yet reached . In order to define cut-off points for vitamin D whilst taking into account extraskeletal health effects , r and omized controlled trials in these fields are warranted . The experts do emphasize that there is evidence to suggest an important role for vitamin D in the maintenance of optimal bone health at all ages and that vitamin D supplementation , in most studies co-administered with calcium , reduces fracture risk in the senior population . Conclusion To reach a serum 25-hydroxyvitamin D level of 50 nmol/l older adults aged ≥65 years are therefore recommended to meet a mean daily vitamin D intake of 20 μg ( 800 IU ) , which is best achieved with a supplement",
"Context : Available evidence shows an association of vitamin D with and rogen levels in men . However , results from preliminary r and omized controlled trials ( RCTs ) are conflicting . Objective : To evaluate whether vitamin D supplementation increases total testosterone ( TT ) levels in healthy men . Design : The Graz Vitamin D&TT‐ RCT is a single‐center , double‐blind , r and omized , placebo‐controlled trial conducted between December 2012 and January 2017 . Setting : Endocrine outpatient clinic at the Medical University of Graz , Austria . Participants : Ninety‐eight healthy men with TT levels ≥10.4 nmol/L and 25‐hydroxyvitamin D [ 25(OH)D ] levels Intervention : Subjects were r and omly assigned to receive 20,000 IU/wk of vitamin D3 ( n = 50 ) or placebo ( n = 50 ) for 12 weeks . Main Outcome Measures : Primary outcome was TT measured using mass spectrometry . Secondary outcomes were free testosterone , sex hormone‐binding globulin , estradiol , follicle‐stimulating hormone , and luteinizing hormone levels ; free and rogen index ; metabolic characteristics ; and body composition . Results : In healthy men [ mean values ± st and ard deviation : age , 39 years ( ±13 years ) ; 25(OH)D level , 53.3 nmol/L ( ±18.3 nmol/L ) ; TT , 19.1 nmol/L ( ±5.6 nmol/l ) ] , no significant treatment effect on TT was found ; however , there were significant effects on quantitative insulin sensitivity check index ( QUICKI ) and a trend toward decreased Matsuda index . In the treatment group , median ( interquartile range ) changes for TT , QUICKI , and Matsuda index were 0.5 nmol/L ( −0.63 to 0.63 nmol/L ; P = 0.497 ) , −0.02 ( −0.04 to 0.01 ; P = 0.034 ) , and −0.9 ( −3.2 to 0.8 ; P = 0.051 ) , respectively . Conclusion : Vitamin D treatment had no effect on TT levels in middle‐aged healthy men with normal baseline TT , but it significantly decreased QUICKI . Additional studies investigating vitamin D effects on TT and insulin sensitivity in healthy men are required",
"Context Results of animal models and cross-sectional cohort studies have suggested a beneficial role for vitamin D in male reproduction . Objective Determine the effect of vitamin D and calcium supplementation on semen quality in infertile men with serum 25-hydroxyvitamin-D ( 25OHD ) levels ≤50 nmol/L. Design A single-center , triple-blinded , r and omized clinical trial . Participants A total of 1427 infertile men were screened to include 330 ; 1002 men did not meet inclusion criteria and 95 did not wish to participate . Intervention The active group received cholecalciferol 300,000 IU initially , then 1400 IU cholecalciferol and 500 mg of calcium daily for 150 days ; the other group received placebo . Results Serum concentrations of 25OHD and 1,25-dihydroxyvitamin D3 were significantly higher in men in the treatment group compared with the placebo group . Vitamin D supplementation was not associated with changes in semen parameters , although spontaneous pregnancies tended to be higher in couples in which the man was in the treatment group [ 7.3 % vs 2.4 % , Δ5.0 % ( -0.6 % ; 10.5 % ) ] . Vitamin D treatment in a subgroup of oligozoospermic men increased the chance for a live birth compared with placebo [ 35.6 % vs 18.3 % , Δ17.3 % ( 1.6 % ; 32.9 % ) ] . Moreover , serum inhibin B levels were higher in men deficient in vitamin D who were r and omly assigned to receive high-dose vitamin D [ 193 pg/mL vs 143 pg/mL , Δ49 pg/mL ( 8 ; 91 pg/mL ) ] ; however , the increase in sperm concentration was not significantly higher than in the placebo group ( P = 0.07 ) . Conclusion High-dose vitamin D supplementation did not improve semen quality in vitamin D-insufficient infertile men . The positive impact of vitamin D supplementation on live birth rate and serum inhibin B in oligozoospermic and vitamin D-deficient men may be of clinical importance and warrant verification by others",
"Context : Single-nucleotide polymorphisms ( SNPs ) in genes related to vitamin D metabolism have been associated with serum 25-hydroxyvitamin D [ 25(OH)D ] concentration , but these relationships have not been examined following antenatal cholecalciferol supplementation . Objective : To determine whether SNPs in DHCR7 , CYP2R1 , CYP24A1 , and GC are associated with the response to gestational cholecalciferol supplementation . Design : Within-r and omization group analysis of the Maternal Vitamin D Osteoporosis Study trial of antenatal cholecalciferol supplementation . Setting : Hospital antenatal clinics . Participants : In total , 682 women of white ethnicity ( 351 placebo , 331 cholecalciferol ) were included . SNPs at rs12785878 ( DHCR7 ) , rs10741657 ( CYP2R1 ) , rs6013897 ( CYP24A1 ) , and rs2282679 ( GC ) were genotyped . Interventions : 1000 IU/d cholecalciferol from 14 weeks of gestation until delivery . Main Outcome Measure : 25(OH)D at r and omization and 34 weeks of gestation were measured in a single batch ( Liaison ; Diasorin , Dartford , UK ) . Associations between 25(OH)D and the SNPs were assessed by linear regression using an additive model [ β represents the change in 25(OH)D per additional common allele ] . Results : Only rs12785878 ( DHCR7 ) was associated with baseline 25(OH)D [ β = 3.1 nmol/L ; 95 % confidence interval ( CI ) , 1.0 to 5.2 nmol/L ; P with achieved 25(OH)D status following supplementation , whereas rs12785878 and rs6013897 ( CYP24A1 ) were not . Conclusions : Genetic variation in DHCR7 , which encodes 7-dehyrocholesterol reductase in the epidermal vitamin D bio synthesis pathway , appears to modify baseline 25(OH)D. In contrast , the response to antenatal cholecalciferol supplementation was associated with SNPs in CYP2R1 , which may alter 25-hydroxylase activity , and GC , which may affect vitamin D binding protein synthesis or metabolite affinity",
"BACKGROUND Vitamin D plays pivotal role in decidualization and implantation of the placenta . Recent research es have shown that low level of vitamin D3 \" 25-hydroxyvitamin D ( 25[OH]D ) \" in serum is a risk factor for pre-eclampsia . Latest evidence supports role of vitamin D3 deficiency treatment in reducing the risk of pre-eclampsia . The aim of this study is to determine the effect of antenatal supplementation of vitamin D3 on the risk of pre-eclampsia and to explore the dose effect in attaining the vitamin D3 normal level . METHOD An open labelled r and omized controlled study was conducted on 179 pregnant women presenting in King Fahad Medical City antenatal clinic from Oct 2012-Oct 2015 . Patients with age less than 20 years or more than 40 years , pregnancy with fetal anomalies , history of hypertension , pre-eclampsia , recurrent miscarriage , chronic renal or hepatic disease and malignancy were excluded from the study . Serum 25[OH]D was analysed during the first trimester ( between 6 and 12 weeks of pregnancy ) . Patients with vitamin D3 deficiency ( serum levels were included in the study and r and omized for vitamin D3 supplementation 400 IU ( Group 1 ) versus 4000 IU ( Group 2 ) . Both groups were compared for the prevalence of pre-eclampsia and dose effect on vitamin D level . RESULTS Of 179 gravidae enrolled , 164 completed the trial . Mean maternal 25[OH]D was significantly increased in group 2 from 16.3 ± 5 nmol/mL to 72.3 ± 30.9 nmol/mL compared with group 1 from 17.5 ± 6.7 nmol/mL to 35.3 ± 20.7 nmol/mL ( p > 0.0001 ) . The relative risk reduction ( RRR ) for attaining ≥75 nmol/L before delivery was significantly higher ( RRR 93.2 [ CI 79 - 98 ] when treated with 4000 IU . The total incidence of pre-eclampsia in the study population was 4.3 % . In comparison to group 1 , the group 2 reported fewer pre-eclampsia events during the study period ( 8.6 % versus 1.2 % ; p was lesser in the group 2 ( 9.6 % ) versus group 1 ( 22.2 % ) ; p = 0.027 . However , other obstetric outcomes were comparable between both groups . CONCLUSION Vitamin D supplementation in the deficient group reduces the risk of pre-eclampsia and IUGR in a dose dependant manner . However larger clinical trials are essential to investigate optimum dosage of vitamin D3 in this group",
"BACKGROUND Maternal vitamin D status has been associated with bone mass of offspring in many , but not all , observational studies . However , maternal vitamin D repletion during pregnancy has not yet been proven to improve offspring bone mass in a r and omised controlled trial . We aim ed to assess whether neonates born to mothers supplemented with vitamin D during pregnancy have greater whole-body bone mineral content ( BMC ) at birth than those of mothers who had not received supplementation . METHODS The Maternal Vitamin D Osteoporosis Study ( MAVIDOS ) was a multicentre , double-blind , r and omised , placebo-controlled trial that recruited pregnant women from three study sites in the UK ( Southampton , Oxford , and Sheffield ) . Eligible participants were older than 18 years , with a singleton pregnancy , gestation of less than 17 weeks , and a serum 25-hydroxyvitamin D ( 25[OH]D ) concentration of 25 - 100 nmol/L at 10 - 17 weeks ' gestation . P'articipants were r and omly assigned ( 1:1 ) , in r and omly permuted blocks of ten , to either cholecalciferol 1000 IU/day or matched placebo , taken orally , from 14 weeks ' gestation ( or as soon as possible before 17 weeks ' gestation if recruited later ) until delivery . Participants and the research team were masked to treatment allocation . The primary outcome was neonatal whole-body BMC , assessed within 2 weeks of birth by dual-energy x-ray absorptiometry ( DXA ) , analysed in all r and omly assigned neonates who had a usable DXA scan . Safety outcomes were assessed in all r and omly assigned participants . This trial is registered with the International St and ard R and omised Controlled Trial registry , IS RCT N 82927713 , and the European Clinical Trials Data base , EudraCT 2007 - 001716 - 23 . FINDINGS Between Oct 10 , 2008 , and Feb 11 , 2014 , we r and omly assigned 569 pregnant women to placebo and 565 to cholecalciferol 1000 IU/day . 370 ( 65 % ) neonates in the placebo group and 367 ( 65 % ) neonates in the cholecalciferol group had a usable DXA scan and were analysed for the primary endpoint . Neonatal whole-body BMC of infants born to mothers assigned to cholecalciferol 1000 IU/day did not significantly differ from that of infants born to mothers assigned to placebo ( 61·6 g [ 95 % CI 60·3 - 62·8 ] vs 60·5 g [ 59·3 - 61·7 ] , respectively ; p=0·21 ) . We noted no significant differences in safety outcomes , apart from a greater proportion of women in the placebo group with severe post-partum haemorrhage than those in the cholecalciferol group ( 96 [ 17 % ] of 569 mothers in the placebo group vs 65 [ 12 % ] of 565 mothers in the cholecalciferol group ; p=0·01 ) . No adverse events were deemed to be treatment related . INTERPRETATION Supplementation of women with cholecalciferol 1000 IU/day during pregnancy did not lead to increased offspring whole-body BMC compared with placebo , but did show that 1000 IU of cholecalciferol daily is sufficient to ensure that most pregnant women are vitamin D replete , and it is safe . These findings support current approaches to vitamin D supplementation in pregnancy . Results of the ongoing MAVIDOS childhood follow-up study are awaited . FUNDING Arthritis Research UK , Medical Research Council , Bupa Foundation , and National Institute for Health Research",
"Context Intake of hormonal contraceptives ( HC ) is associated with higher total 25-hydroxyvitamin D [ 25(OH)D ] concentrations , but the effect of HC on free 25(OH)D is unclear . Objective We investigated whether free 25(OH)D concentrations differ according to use of HC . Design This is a post hoc analysis of a r and omized open trial . Setting This study was conducted from 13 January to 9 May , 2016 , at a clinical research organization in Esslingen , Germany . Participants We included 201 apparently healthy women of childbearing age . Intervention Participants were r and omly assigned to receive a daily multimicronutrient supplement for 8 weeks ; the supplement contained 200 IU ( n = 100 ) or 800 IU ( n = 101 ) of vitamin D3 . Main Outcome Measures Primary outcome was the difference in free 25(OH)D between users and nonusers of HC . Results Overall , 176 participants [ median ( 25th to 75th percentiles ) age : 25 ( 22 to 29 ) years ] with available free 25(OH)D were included in the present analysis . At baseline , total 25(OH)D was significantly higher in users ( n = 110 ) than in nonusers ( n = 66 ) of HC [ 49.2 ( 33.4 to 63.4 ) vs 39.1 ( 23.8 to 52.5 ) nmol/L ; P free 25(OH)D [ 7.87 ( 6.50 to 10.11 ) vs 7.88 ( 6.35 to 10.12 ) pmol/L ; P = 0.923 ] . These results were confirmed after multimicronutrient supplementation and in subgroups according to treatment allocation . Conclusions Use of HC was associated with , on average , 26 % higher total 25(OH)D , whereas free 25(OH)D values did not differ according to use of HC . These findings are relevant for epidemiological studies , but the physiological implication s remain to be clarified",
"The need , safety , and effectiveness of vitamin D supplementation during pregnancy remain controversial . In this r and omized , controlled trial , women with a singleton pregnancy at 12 to 16 weeks ' gestation received 400 , 2000 , or 4000 IU of vitamin D(3 ) per day until delivery . The primary outcome was maternal/neonatal circulating 25-hydroxyvitamin D [ 25(OH)D ] concentration at delivery , with secondary outcomes of a 25(OH)D concentration of 80 nmol/L or greater achieved and the 25(OH)D concentration required to achieve maximal 1,25-dihydroxyvitamin D(3 ) [ 1,25(OH)(2)D(3 ) ] production . Of the 494 women enrolled , 350 women continued until delivery : Mean 25(OH)D concentrations by group at delivery and 1 month before delivery were significantly different ( p relative risk ( RR ) for achieving a concentration of 80 nmol/L or greater within 1 month of delivery was significantly different between the 2000- and the 400-IU groups ( RR = 1.52 , 95 % CI 1.24 - 1.86 ) , the 4000- and the 400-IU groups ( RR = 1.60 , 95 % CI 1.32 - 1.95 ) but not between the 4000- and . 2000-IU groups ( RR = 1.06 , 95 % CI 0.93 - 1.19 ) . Circulating 25(OH)D had a direct influence on circulating 1,25(OH)(2)D(3 ) concentrations throughout pregnancy ( p safety measure . Not a single adverse event was attributed to vitamin D supplementation or circulating 25(OH)D levels . It is concluded that vitamin D supplementation of 4000 IU/d for pregnant women is safe and most effective in achieving sufficiency in all women and their neonates regardless of race , whereas the current estimated average requirement is comparatively ineffective at achieving adequate circulating 25(OH)D concentrations , especially in African Americans",
"The early days of nutritional science were a heady time . Working out the metabolic roles and many benefits of specific nutrients was both exciting and clearly important . In more recent times , emphasis has shifted somewhat from metabolism to policy . In a sense , this represents a major victory for nutrition . Less than a century ago , E. V. McCollum had to struggle with the prevailing notion that food was primarily fuel . The idea that not eating something could make one sick was considered laughable . Now , it is taken for granted that the quality of what we eat is at least as important as the quantity , an underst and ing that leads naturally to the determining of nutrient intake requirements . It is not surprising , therefore , that 7 of the last 14 Atwater lectures dealt more or less explicitly with the issue of requirements . This one will be no exception to that pattern . In my McCollum lecture of 5 y ago ( 1 ) , I called attention to what I perceived as a broadening of the way deficiency disease might be conceptualized . The original nutrient deficiency diseases were all of short latency and involved discrete body systems and dysfunctions . Rickets , pellagra , and beriberi are good cases in point . And , while the working science has progressed far beyond these beginnings , these short latency diseases have remained the implicit model for much of our thinking about nutritional deficiency and , to a substantial extent , our determination of nutrient intake requirements . For example , in the first of the dietary reference intake books , that for bone-related nutrients ( 2 ) , the intake requirement for vitamin D was explicitly pegged solely to the prevention of rickets/osteomalacia . As is evident on a moment ’s reflection , short latency was a prerequisite for the discovery of a connection between nutrient intake and disease . Had the outcome of an inadequate intake not been discrete and not been manifested promptly , it is doubtful that we ever would have recognized the connection between cause and effect ( i.e. nutrient intake and health or disease ) . But the science has gone far beyond that point , and it seems that there is no inherent reason why inadequate intake of the same nutrients involved in short-latency diseases could not be producing long latency deficiency disease as well . Moreover , as is now generally recognized , nutrients act through multiple mechanisms , and low intakes might be expected to lead to disorders quite distinct from the disease originally connected with the nutrient . Vitamin D is a good case in point . Total body inputs closer to those that must have prevailed during hominid evolution are associated with reduced risk of disorders as varied as Type I diabetes , hypertension , osteoporosis , various cancers , multiple sclerosis , and periodontal disease , to name only some ( 3–24 ) . ( For several of these disorders there is now what is referred to as ‘ ‘ level I evidence , ’’ i.e. r and omized controlled trials , confirming what had been found both in observational studies and in extensive bench and small animal studies . ) This broadened scheme is illustrated graphically in Figure 1",
"OBJECTIVE To determine whether a single monthly supplement is as effective as a daily maternal supplement in increasing breast milk vitamin D to achieve vitamin D sufficiency in their infants . PATIENTS AND METHODS Forty mothers with exclusively breast-fed infants were r and omized to receive oral cholecalciferol ( vitamin D3 ) 5000 IU/d for 28 days or 150,000 IU once . Maternal serum , breast milk , and urine were collected on days 0 , 1 , 3 , 7 , 14 , and 28 ; infant serum was obtained on days 0 and 28 . Enrollment occurred between January 7 , 2011 , and July 29 , 2011 . RESULTS In mothers given daily cholecalciferol , concentrations of serum and breast milk cholecalciferol attained steady levels of 18 and 8 ng/mL , respectively , from day 3 through 28 . In mothers given the single dose , serum and breast milk cholecalciferol peaked at 160 and 40 ng/mL , respectively , at day 1 before rapidly declining . Maternal milk and serum cholecalciferol concentrations were related ( r=0.87 ) . Infant mean serum 25-hydroxyvitamin D concentration increased from 17±13 to 39±6 ng/mL in the single-dose group and from 16±12 to 39±12 ng/mL in the daily-dose group ( P=.88 ) . All infants achieved serum 25-hydroxyvitamin D concentrations of more than 20 ng/mL. CONCLUSION Either single-dose or daily-dose cholecalciferol supplementation of mothers provided breast milk concentrations that result in vitamin D sufficiency in breast-fed infants . CLINICAL TRIAL REGISTRATION clinical trials.gov NCT01240265",
"Introduction Maternal vitamin D status in pregnancy has been linked to many health outcomes in mother and offspring . A wealth of observational studies have reported on both obstetric outcomes and complications , including pre-eclampsia , gestational diabetes , mode and timing of delivery . Many foetal and childhood outcomes are also linked to vitamin D status , including measures of foetal size , body composition and skeletal mineralization , in addition to later childhood outcomes , such as asthma . Sources of data Synthesis of systematic and narrative review s. Areas of agreement and controversy The findings are generally inconsistent in most areas , and , at present , there is a lack of data from high- quality intervention studies to confirm a causal role for vitamin D in these outcomes . In most areas , the evidence tends towards maternal vitamin D being of overall benefit , but often does not reach statistical significance in meta-analyses . Growing points and areas timely for developing research The most conclusive evidence is in the role of maternal vitamin D supplementation in the prevention of neonatal hypocalcaemia ; as a consequence the UK department of health recommends that pregnant women take 400 IU vitamin D daily . High- quality r and omized placebo-controlled trials , such as the UK-based MAVIDOS trial , will inform the potential efficacy and safety of vitamin D supplementation in pregnancy across a variety of outcomes",
"Background Vitamin D deficiency has become a global health issue in pregnant women . This study aim ed to assess the adequacy of maternal vitamin D status by measuring maternal serum and breast milk 25-hydroxyvitamin D [ 25(OH)D ] levels and to determine the association between maternal serum and milk 25(OH)D levels . Methods Data was obtained from the Universiti Sains Malaysia Pregnancy Cohort Study . This study was conducted from April 2010 to December 2012 in the state of Kelantan , Malaysia . Blood sample s from pregnant women aged 19 to 40 years were drawn in the second and third trimesters of pregnancy , while breast milk sample s at delivery , 2 , 6 and 12 months postpartum were collected to analyze for 25(OH)D levels . A total of 102 pregnant women were included in the analysis . Results Vitamin D deficiency [ 25(OH)D . Multivitamin intakes during pregnancy were significantly associated with higher serum 25(OH)D levels in the second trimester ( β = 9.16 , p = 0.005 ) and the third trimester ( β = 13.65 , p = 0.003 ) . 25(OH)D levels in breast milk during the first year of lactation ranged from 1.01 to 1.26 nmol/L. Higher maternal serum 25(OH)D level in the second trimester of pregnancy was associated with an elevated level of 25(OH)D in breast milk at delivery ( β = 0.002 , p = 0.026 ) . Conclusions This study shows that high proportions of Malay pregnant women are at risk of vitamin D deficiency . Maternal vitamin D status in the second trimester of pregnancy was found to influence vitamin D level in breast milk at delivery",
"OBJECTIVE : Compare effectiveness of maternal vitamin D3 supplementation with 6400 IU per day alone to maternal and infant supplementation with 400 IU per day . METHODS : Exclusively lactating women living in Charleston , SC , or Rochester , NY , at 4 to 6 weeks postpartum were r and omized to either 400 , 2400 , or 6400 IU vitamin D3/day for 6 months . Breastfeeding infants in 400 IU group received oral 400 IU vitamin D3/day ; infants in 2400 and 6400 IU groups received 0 IU/day ( placebo ) . Vitamin D deficiency was defined as 25-hydroxy-vitamin D ( 25(OH)D ) Maternal serum vitamin D , 25(OH)D , calcium , and phosphorus concentrations and urinary calcium/creatinine ratios were measured at baseline then monthly , and infant blood parameters were measured at baseline and months 4 and 7 . RESULTS : Of the 334 mother-infant pairs in 400 IU and 6400 IU groups at enrollment , 216 ( 64.7 % ) were still breastfeeding at visit 1 ; 148 ( 44.3 % ) continued full breastfeeding to 4 months and 95 ( 28.4 % ) to 7 months . Vitamin D deficiency in breastfeeding infants was greatly affected by race . Compared with 400 IU vitamin D3 per day , 6400 IU/day safely and significantly increased maternal vitamin D and 25(OH)D from baseline ( P vitamin D supplementation with 6400 IU/day safely supplies breast milk with adequate vitamin D to satisfy her nursing infant ’s requirement and offers an alternate strategy to direct infant supplementation",
"BACKGROUND Human milk is typically low in vitamin D activity ( VDA ) . Whether the vitamin D content of breast milk at birth can be increased by supplementing the mother during pregnancy has not been reported to the best of our knowledge . OBJECTIVE We examined the effect of vitamin D supplementation during pregnancy on breast-milk VDA in the first 2 mo of lactation . DESIGN Breast-milk sample s were obtained from women who were enrolled in a r and omized , double-blinded , placebo-controlled trial of vitamin D supplementation during pregnancy . Pregnant women were enrolled at 27 wk of gestation and r and omly assigned to the following 3 groups : a placebo group , a group who received one dosage of daily oral vitamin D3 ( 1000 IU ) , or a group who received 2 dosages of daily oral vitamin D3 ( 2000 IU ) . Serum 25-hydroxyvitamin D [ 25(OH)D ] was measured at enrollment , at 36 wk of gestation , and in cord blood at birth . Study participants who were breastfeeding were invited to provide breast-milk sample s for VDA measurement [ concentration of vitamin D2 , vitamin D3 , 25(OH)D2 , and 25(OH)D3 ] at 2 wk and 2 mo postpartum . A linear mixed model was used to compare breast-milk VDA between the 3 study groups . RESULTS A total of 75 women provided breast-milk sample s ( 44 women provided breast-milk sample s at both 2 wk and 2 mo postpartum ) . The mean ( 95 % CI ) VDA at age 2 wk was 52 IU/L ( 12 , 217 IU/L ) in the placebo group , 51 IU/L ( 17 , 151 IU/L ) in the 1000-IU group , and 74 IU/L ( 25 , 221 IU/L ) in the 2000-IU group ; and at age 2 mo , the mean ( 95 % CI ) VDA was 45 IU/L ( 16 , 124 IU/L ) , 43 IU/L ( 18 , 103 IU/L ) , and 58 IU/L ( 15 , 224 IU/L ) , respectively . There was no significant interaction in VDA between the sample - collection time and treatment ( P = 0.61 ) , but there was a difference between lower- and higher-dosage treatment groups ( P = 0.04 ) . CONCLUSION Maternal vitamin D supplementation during pregnancy of 2000 IU/d ( compared with 1000 IU/d and with a placebo ) results in a higher VDA of breast milk ≥2 mo postpartum . This trial was registered at the Australian New Zeal and Clinical Trials Registry as ACTRN12610000483055",
"INTRODUCTION Mothers and infants are at high risk for inadequate vitamin D status . Mechanisms by which vitamin D may affect maternal and infant DNA methylation are poorly understood . OBJECTIVE This study quantified the effects of vitamin D3 supplementation on DNA methylation in pregnant and lactating women and their breastfed infants . MATERIAL S AND METHODS In this r and omized controlled pilot study , pregnant women received vitamin D3 400 international units ( IU ) ( n = 6 ; control ) or 3,800 IU ( n = 7 ; intervention ) daily from late second trimester through 4 - 6 weeks postpartum . Epigenome-wide DNA methylation was quantified in leukocytes collected from mothers at birth and mother-infant dyads at 4 - 6 weeks postpartum . RESULTS At birth , intervention group mothers showed DNA methylation gain and loss at 76 and 89 cytosine-guanine ( CpG ) dinucleotides , respectively , compared to controls . Postpartum , methylation gain was noted at 200 and loss at 102 CpGs . Associated gene clusters showed strongest biologic relevance for cell migration/motility and cellular membrane function at birth and cadherin signaling and immune function at postpartum . Breastfed 4 - 6-week-old infants of intervention mothers showed DNA methylation gain and loss in 217 and 213 CpGs , respectively , compared to controls . Genes showing differential methylation mapped most strongly to collagen metabolic processes and regulation of apoptosis . CONCLUSIONS Maternal vitamin D supplementation during pregnancy and lactation alters DNA methylation in mothers and breastfed infants . Additional work is needed to fully eluci date the short- and long-term biologic effects of vitamin D supplementation at varying doses , which could hold important implication s for establishing clinical recommendations for prenatal and offspring health promotion",
"This article summarizes the new 2011 report on dietary requirements for calcium and vitamin D from the Institute of Medicine ( IOM ) . An IOM Committee charged with determining the population needs for these nutrients in North America conducted a comprehensive review of the evidence for both skeletal and extraskeletal outcomes . The Committee concluded that available scientific evidence supports a key role of calcium and vitamin D in skeletal health , consistent with a cause- and -effect relationship and providing a sound basis for determination of intake requirements . For extraskeletal outcomes , including cancer , cardiovascular disease , diabetes , and autoimmune disorders , the evidence was inconsistent , inconclusive as to causality , and insufficient to inform nutritional requirements . R and omized clinical trial evidence for extraskeletal outcomes was limited and generally uninformative . Based on bone health , Recommended Dietary Allowances ( RDAs ; covering requirements of ≥97.5 % of the population ) for calcium range from 700 to 1300 mg/d for life-stage groups at least 1 yr of age . For vitamin D , RDAs of 600 IU/d for ages 1–70 yr and 800 IU/d for ages 71 yr and older , corresponding to a serum 25-hydroxyvitamin D level of at least 20 ng/ml ( 50 nmol/liter ) , meet the requirements of at least 97.5 % of the population . RDAs for vitamin D were derived based on conditions of minimal sun exposure due to wide variability in vitamin D synthesis from ultraviolet light and the risks of skin cancer . Higher values were not consistently associated with greater benefit , and for some outcomes U-shaped associations were observed , with risks at both low and high levels . The Committee concluded that the prevalence of vitamin D inadequacy in North America has been overestimated . Urgent research and clinical priorities were identified , including re assessment of laboratory ranges for 25-hydroxyvitamin D , to avoid problems of both undertreatment and overtreatment",
"Context Despite evidence on the association between hypovitaminosis D and adverse pregnancy outcomes and the positive impact of vitamin D supplementation , no evidence exists supporting a universal screening program in pregnancy as part of routine prenatal care . Objective We sought to determine the effectiveness of a prenatal screening program on optimizing 25-hydroxyvitamin D [ 25(OH)D ] levels and preventing pregnancy complications . Also , to identify a safe regimen , we compared several regimens in a subgroup of vitamin D-deficient pregnant women . Design Two cities of Masjed-Soleyman and Shushtar from Khuzestan province , Iran , were selected as the screening and nonscreening arms , respectively . Within the screening arm , a r and omized controlled trial was conducted on 800 pregnant women . Setting Health centers of Masjed-Soleyman and Shushtar cities . Patients or Participants Pregnant women aged 18 to 40 years . Intervention Women with moderate [ 25(OH)D , 10 to 20 ng/mL ] and severe [ 25(OH)D , were r and omly divided into four subgroups and received vitamin D3 ( D3 ) until delivery . Main Outcome Measure Maternal concentration of 25(OH)D at delivery and rate of pregnancy complications . Results After supplementation , only 2 % of the women in the nonscreening site met the sufficiency level ( > 20 ng/mL ) vs 53 % of the women in the screening site . Adverse pregnancy outcomes , including preeclampsia , gestational diabetes mellitus , and preterm delivery , were decreased by 60 % , 50 % , and 40 % , respectively , in the screening site . A D3 injection in addition to monthly 50,000 IU maintenance therapy contributed the most to achievement of sufficient levels at delivery . Conclusions A prenatal vitamin D screening and treatment program is an effective approach in detecting deficient women , improving 25(OH)D levels , and decreasing pregnancy adverse outcomes",
"ABSTRACT Background In the absence of dose-response data , Dietary Reference Values for vitamin D in nonpregnant adults are extended to pregnancy . Objective The aim was to estimate vitamin D intake needed to maintain maternal 25-hydroxyvitamin D [ 25(OH)D ] in late gestation at a concentration sufficient to prevent newborn 25(OH)D placebo-controlled trial in Cork , Irel and ( 51.9oN ) . A total of 144 white-skinned pregnant women were assigned to receive 0 , 10 ( 400 IU ) , or 20 ( 800 IU ) µg vitamin D3/d from ≤18 wk of gestation . Vitamin D metabolites at 14 , 24 , and 36 wk of gestation and in cord sera , including 25(OH)D3 , 3-epi-25(OH)D3 , 24,25(OH)2D3 , and 25(OH)D2 were quantified by liquid chromatography – t and em mass spectrometry . A curvilinear regression model predicted the total vitamin D intake ( from diet and antenatal supplements plus treatment dose ) that maintained maternal 25(OH)D in late gestation at a concentration sufficient to maintain cord 25(OH)D at ≥25–30 nmol/L. Results Mean ± SD baseline 25(OH)D was 54.9 ± 10.7 nmol/L. Total vitamin D intakes at the study endpoint ( 36 wk of gestation ) were 12.1 ± 8.0 , 21.9 ± 5.3 , and 33.7 ± 5.1 µg/d in the placebo and 10-µg and 20-µg vitamin D3 groups , respectively ; and 25(OH)D was 24.3 ± 5.8 and 29.2 ± 5.6 nmol/L higher in the 10- and 20-µg groups , respectively , compared with placebo ( P For maternal 25(OH)D concentrations ≥50 nmol/L , 95 % of cord sera were ≥30 nmol/L and 99 % were > 25 nmol/L. The estimated vitamin D intake required to maintain serum 25(OH)D at ≥50 nmol/L in 97.5 % of women was 28.9 µg/d . Conclusions Thirty micrograms of vitamin D per day safely maintained serum 25(OH)D concentrations at ≥50 nmol/L in almost all white-skinned women during pregnancy at a northern latitude , which kept 25(OH)D at > 25 nmol/L in 99 % and ≥30 nmol/L in 95 % of umbilical cord sera . This trial was registered at www . clinical trials.gov as NCT02506439",
"Abstract Objective To use mendelian r and omisation to investigate whether 25-hydroxyvitamin D concentration has a causal effect on gestational hypertension or pre-eclampsia . Design One and two sample mendelian r and omisation analyses . Setting Two European pregnancy cohorts ( Avon Longitudinal Study of Parents and Children , and Generation R Study ) , and two case-control studies ( subgroup nested within the Norwegian Mother and Child Cohort Study , and the UK Genetics of Pre-eclampsia Study ) . Participants 7389 women in a one sample mendelian r and omisation analysis ( 751 with gestational hypertension and 135 with pre-eclampsia ) , and 3388 pre-eclampsia cases and 6059 controls in a two sample mendelian r and omisation analysis . Exposures Single nucleotide polymorphisms in genes associated with vitamin D synthesis ( rs10741657 and rs12785878 ) and metabolism ( rs6013897 and rs2282679 ) were used as instrumental variables . Main outcome measures Gestational hypertension and pre-eclampsia defined according to the International Society for the Study of Hypertension in Pregnancy . Results In the conventional multivariable analysis , the relative risk for pre-eclampsia was 1.03 ( 95 % confidence interval 1.00 to 1.07 ) per 10 % decrease in 25-hydroxyvitamin D level , and 2.04 ( 1.02 to 4.07 ) for 25-hydroxyvitamin D levels gestational hypertension . The one sample mendelian r and omisation analysis using the total genetic risk score as an instrument did not provide strong evidence of a linear effect of 25-hydroxyvitamin D on the risk of gestational hypertension or pre-eclampsia : odds ratio 0.90 ( 95 % confidence interval 0.78 to 1.03 ) and 1.19 ( 0.92 to 1.52 ) per 10 % decrease , respectively . The two sample mendelian r and omisation estimate gave an odds ratio for pre-eclampsia of 0.98 ( 0.89 to 1.07 ) per 10 % decrease in 25-hydroxyvitamin D level , an odds ratio of 0.96 ( 0.80 to 1.15 ) per unit increase in the log(odds ) of 25-hydroxyvitamin D level gestational hypertension or pre-eclampsia . Future mendelian r and omisation studies with a larger number of women with pre-eclampsia or more genetic instruments that would increase the proportion of 25-hydroxyvitamin D levels explained by the instrument are needed",
"BACKGROUND Vitamin D deficiency during pregnancy is associated with adverse pregnancy outcomes , although the association between preconception vitamin D concentrations and livebirth is unknown . We aim ed to assess the association between preconception vitamin D and pregnancy outcomes among women with proven fecundity . METHODS We did a secondary analysis of a prospect i ve cohort from the block-r and omised , double-blind , placebo-controlled EAGeR trial . Women aged 18 - 40 years with one to two previous pregnancy losses were recruited from June 15 , 2007 , to July 15 , 2011 , at four clinical sites in the USA and followed up for up to six menstrual cycles while attempting pregnancy and throughout pregnancy if they conceived . Serum 25-hydroxyvitamin D was measured at baseline ( preconception ) and 8 weeks of gestation . Outcomes of interest included clinical pregnancy , time to pregnancy , pregnancy loss , and livebirths . Risk ratios ( RRs ) and 95 % CIs for livebirths , pregnancy , and pregnancy loss were estimated with weighted log-binomial regression . To assess time to pregnancy , we used discrete time Cox proportional hazards models to calculate fecundability odds ratios ( FORs ) with 95 % CIs . EAGeR is registered with Clinical Trials.gov , number NCT00467363 . FINDINGS 1191 women had available data on preconception 25-hydroxyvitamin D concentrations . 555 ( 47 % ) women were classified as having sufficient concentrations ( ≥75 nmol/L ) and 636 ( 53 % ) as having insufficient concentrations ( achieve clinical pregnancy ( adjusted RR 1·10 [ 1·01 - 1·20 ] ) and livebirth ( 1·15 [ 95 % CI 1·02 - 1·29 ] ) than were women with insufficient concentrations . Among women who achieved pregnancy , sufficient preconception 25-hydroxyvitamin D , but not that at 8 weeks of gestation , was associated with reduced risk of pregnancy loss ( preconception RR per 25 nmol/L 0·88 [ 95 % CI 0·77 - 0·99 ] ; 8 weeks of gestation 0·98 [ 0·95 - 1·01 ] ) . No association was observed with fecundability in women with sufficient versus those with insufficient preconception 25-hydroxyvitamin D concentrations ( adjusted FOR 1·13 [ 95 % CI 0·95 - 1·34 ] ) . INTERPRETATION Sufficient preconception 25-hydroxyvitamin D ( ≥75 nmol/L ) was associated with increased likelihood of pregnancy and livebirth . Increased vitamin D concentrations before conception , but not in early pregnancy , were associated with reduced pregnancy loss . FUNDING National Institutes of Health and Doris Duke Charitable Foundation"
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Objectives This meta- analysis aim ed to demonstrate the impact of preoperative exercise therapy on surgical outcomes in patients with lung cancer and COPD . Pulmonary function and muscle capacity were investigated to explore their potential links with outcome improvements after exercise . Methods Articles were search ed from PubMed , Embase , and the Cochrane Library with criteria of lung cancer patients with or without COPD , undergoing resection , and receiving preoperative exercise training . Key outcomes were analyzed using meta- analysis . Results Seven studies containing 404 participants were included . Patients receiving preoperative exercise training had a lower incidence of postoperative pulmonary complications ( PPCs ; OR 0.44 , 95 % CI 0.27 - 0.71 ) and shorter length of hospital stay ( st and ardized mean difference -4.23 days , 95 % CI -6.14 to -2.32 days ) . Exceptionally , pneumonia incidence remained unchanged . Patients with COPD could not obviously benefit from exercise training to reduce PPCs ( OR 0.44 , 95 % CI 0.18 - 1.08 ) , but still might achieve faster recovery . No significant difference in pulmonary function was observed between the two groups . However , 6MWD and VO2 peak were significantly improved after exercise training . Conclusion Preoperative exercise training may reduce PPCs for lung cancer patients . However , for patients with COPD undergoing lung cancer resection , the role of exercise is uncertain , due to limited data , which calls for more prospect i ve trials on this topic . Rehabilitation exercise strengthens muscle capacity , but does not improve impaired pulmonary function , which emphasizes the possible mechanism of the protocol design
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"OBJECTIVES Poor aerobic fitness is a potential modifiable risk factor for long-term survival and quality of life in patients with lung cancer . This r and omized trial evaluates the impact of adding rehabilitation ( Rehab ) with high-intensity interval training ( HIIT ) before lung cancer surgery to enhance cardiorespiratory fitness and improve long-term postoperative outcome . METHODS Patients with operable lung cancer were r and omly assigned to usual care ( UC , n = 77 ) or to intervention group ( Rehab , n = 74 ) that entailed HIIT that was implemented only preoperatively . Cardiopulmonary exercise testing ( CPET ) and pulmonary functional tests ( PFTs ) including forced vital capacity ( FVC ) , forced expiratory volume ( FEV 1 ) and carbon monoxide transfer factor ( KCO ) were performed before and 1 year after surgery . RESULTS During the preoperative waiting time ( median 25 days ) , Rehab patients participated to a median of 8 HIIT sessions ( interquartile [ IQ ] 25 - 75 % , 7 - 10 ) . At 1 year follow-up , 91 % UC patients and 93 % Rehab patients were still alive ( P = 0.506 ) . Pulmonary functional changes were non-significant and comparable in both groups ( FEV 1 mean -7.5 % , 95 % CI , -3.6 to -12.9 and in KCO mean 5.8 % 95 % CI 0.8 - 11.8 ) Compared with preoperative CPET results , both groups demonstrated similar reduction in peak oxygen uptake ( mean -12.2 % 95 % CI -4.8 to -18.2 ) and in peak work rate ( mean -11.1 % 95 % CI -4.2 to -17.4 ) . CONCLUSIONS Short-term preoperative rehabilitation with HIIT does not improve pulmonary function and aerobic capacity measured at 1 year after lung cancer resection . TRIAL REGISTRY Clinical Trials.gov ; No. NCT01258478 ; www . clinical trials.gov",
"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",
"Background The purpose of the PROLUCA study is to investigate the efficacy of preoperative and early postoperative rehabilitation in a non-hospital setting in patients with operable lung cancer with special focus on exercise . Methods Using a 2x2 factorial design with continuous effect endpoint ( Maximal Oxygen Uptake ( VO2peak ) ) , 380 patients with non-small cell lung cancer ( NSCLC ) stage I-IIIa referred for surgical resection will be r and omly assigned to one of four groups : ( 1 ) preoperative and early postoperative rehabilitation ( starting two weeks after surgery ) ; ( 2 ) preoperative and late postoperative rehabilitation ( starting six weeks after surgery ) ; ( 3 ) early postoperative rehabilitation alone ; ( 4 ) today ’s st and ard care which is postoperative rehabilitation initiated six weeks after surgery . The preoperative rehabilitation program consists of an individually design ed , 30-minute home-based exercise program performed daily . The postoperative rehabilitation program consists of a supervised group exercise program comprising cardiovascular and resistance training two-hour weekly for 12 weeks combined with individual counseling . The primary study endpoint is VO2peak and secondary endpoints include : Six-minute walk distance ( 6MWD ) , one-repetition-maximum ( 1RM ) , pulmonary function , patient-reported outcomes ( PROs ) on health-related quality of life ( HRQoL ) , symptoms and side effects of the cancer disease and the treatment of the disease , anxiety , depression , wellbeing , lifestyle , hospitalization time , sick leave , work status , postoperative complications ( up to 30 days after surgery ) and survival . Endpoints will be assessed at baseline , the day before surgery , pre-intervention , post-intervention , six months after surgery and one year after surgery . Discussion The results of the PROLUCA study may potentially contribute to the identification of the optimal perioperative rehabilitation for operable lung cancer patients focusing on exercise initiated immediately after diagnosis and rehabilitation shortly after surgery . Trial Registration",
"OBJECTIVE The purpose of this study was to investigate the impact of pulmonary rehabilitation on surgical morbidity and lung function in lung cancer patients with chronic obstructive pulmonary disease ( COPD ) . METHODS Prospect ively , 22 lung cancer patients with COPD who underwent lobectomy between 2000 and 2003 were enrolled for this study as a rehabilitation group ( Rehab . Group ) . The criteria of COPD were preoperative forced expiratory volume in 1 second (FEV1)/forced vital capacity ( FVC ) Preoperatively patients performed aggressive pulmonary exercise for two weeks and received chest physiotherapy postoperatively . As a historical control , 60 patients with lung cancer who fulfilled the same criteria but did not receive rehabilitation between 1995 and 1999 ( control group ) were entered in this study . RESULTS Patient background s were all equivalent between the two groups . However , FEV1 and FEV1/FVC were significantly lower in the Rehab . Group ( p Prolonged oxygen supplement and tracheostomy tended to be more frequent in the control group . The ratio of actual postoperative to predicted postoperative FEV1 was significantly better in the Rehab . Group ( p = 0.047 ) . Furthermore , postoperative hospital stay was significantly longer in the control group ( p = 0.0003 ) . CONCLUSION Despite lower FEV1 and FEV1/FVC in the Rehab . Group , postoperative pulmonary complications and long hospital stay could be effectively prevented and FEV1 was well preserved by rehabilitation and physiotherapy",
"Background Patients with advanced stage non-small cell lung cancer ( NSCLC ) or small cell lung cancer ( SCLC ) often experience multidimensional impairments , affecting quality of life during their course of disease . In lung cancer patients with operable disease , several studies have shown that exercise has a positive impact on quality of life and physical functioning . There is limited evidence regarding efficacy for advanced lung cancer patients undergoing palliative treatment . Therefore , the POSITIVE study aims to evaluate the benefit of a 24-week exercise intervention during palliative treatment in a r and omized controlled setting . Methods / design The POSITIVE study is a r and omized , controlled trial investigating the effects of a 24-week exercise intervention during palliative treatment on quality of life , physical performance and immune function in advanced , non-operable lung cancer patients . 250 patients will be recruited in the Clinic for Thoracic Diseases in Heidelberg , enrolment begun in November 2013 . Main inclusion criterion is histologically confirmed NSCLC ( stage IIIa , IIIb , IV ) or SCLC ( Limited Disease-SCLC , Extensive Disease-SCLC ) not amenable to surgery . Patients are r and omized into two groups . Both groups receive weekly care management phone calls ( CMPCs ) with the goal to assess symptoms and side effects . Additionally , one group receives a combined resistance and endurance training ( 3x/week ) . Primary endpoints are quality of life assessed by the Functional Assessment of Cancer Therapy for patients with lung cancer ( FACT-L , subcategory Physical Well-Being ) and General Fatigue measured by the Multidimensional Fatigue Inventory ( MFI-20 ) . Secondary endpoints are physical performance ( maximal voluntary isometric contraction , 6-min walk distance ) , psychosocial ( depression and anxiety ) and immunological parameters and overall survival . Discussion The aim of the POSITIVE trial is the evaluation of effects of a 24-week structured and guided exercise intervention during palliative treatment stages . Analysis of various outcomes ( such as quality of life , physical performance , self-efficacy , psychosocial and immunological parameters ) will contribute to a better underst and ing of the potential of exercise in advanced lung cancer patients . In contrast to other studies with advanced oncological patients the POSITIVE trial provides weekly phone calls to support patients both in the intervention and control group and to segregate the impact of physical activity on quality of life . Trial registration Clinical Trials.gov NCT02055508 ( Date : December 12 , 2013",
"BACKGROUND A predicted postoperative forced expiratory volume in 1 second ( FEV1 ) of less than 800 ml or 40 % of predicted is a common criterion for exclusion of patients from lung resection for cancer . Usually , the predicted postoperative lung function is calculated according to a formula based on the number of lung segments that will be resected . Incentive spirometry and specific inspiratory muscle training are two maneuvers that have been used to enhance lung expansion and inspiratory muscle strength in patients with chronic obstructive pulmonary disease and after lung operation . METHODS Thirty-two patients with chronic obstructive pulmonary disease who were c and i date s for lung resection were r and omized into two groups : 17 patients received specific inspiratory muscle training and incentive spirometry , 1 hour per day , six times a week , for 2 weeks before and 3 months after lung resection ( group A ) and 15 patients were assigned to the control group and received no training ( group B ) . RESULTS Inspiratory muscle strength increased significantly in the training group , both before and 3 months after the operation . In group B , the predicted postoperative FEV1 value consistently underestimated the actual postoperative FEV1 by approximately 70 ml in the lobectomy subgroup and by 110 ml in the pneumonectomy subgroup . In group A , the actual postoperative FEV1 was higher than the predicted postoperative FEV1 by 570 ml in the lobectomy subgroup and by 680 ml in the pneumonectomy subgroup of patients . CONCLUSIONS In patients undergoing lung resection the simple calculation of predicted postoperative FEV1 underestimates the actual postoperative FEV1 by a small fraction . Lung functions can be increased significantly when incentive spirometry and specific inspiratory muscle training are used before and after operation",
"Background Many patients with lung cancer are deconditioned with poor physical fitness . Lung resection reduces physical fitness further , impairing the patient 's ability to function in daily life . Methods We conducted a single-blind r and omised controlled trial of high-intensity endurance and strength training ( 60 min , three times a week , 20 weeks ) , starting 5–7 weeks after surgery . The control group received st and ard postoperative care . The primary outcome was the change in peak oxygen uptake measured directly during walking until exhaustion . Other outcomes included changes in pulmonary function , muscular strength by one-repetition maximum ( 1RM ) , total muscle mass measured by dual energy X-ray absorptiometry , daily physical functioning and quality of life ( QoL ) . Results The intention-to-treat analysis of the 61 r and omised patients showed that the exercise group had a greater increase in peak oxygen uptake ( 3.4 mL/kg/min between-group difference , p=0.002 ) , carbon monoxide transfer factor ( Tlco ) ( 5.2 % predicted , p=0.007 ) , 1RM leg press ( 29.5 kg , p chair st and ( 2.1 times p stair run ( 4.3 steps , p=0.002 ) and total muscle mass ( 1.36 kg , p=0.012 ) compared with the controls . The mean±SD QoL ( SF-36 ) physical component summary score was 51.8±5.5 and 43.3±11.3 ( p=0.006 ) , and the mental component summary score was 55.5±5.3 and 46.6±14.0 ( p=0.015 ) in the exercise and control groups , respectively . Conclusions In patients recently operated for lung cancer , high-intensity endurance and strength training was well tolerated and induced clinical ly significant improvements in peak oxygen uptake , Tlco , muscular strength , total muscle mass , functional fitness and QoL. This study may provide a basis for exercise therapy after lung cancer surgery . Trial registration number NCT01748981",
"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",
"OBJECTIVE To evaluate the effect of 4 weeks of pulmonary rehabilitation ( PR ) versus chest physical therapy ( CPT ) on the preoperative functional capacity and postoperative respiratory morbidity of patients undergoing lung cancer resection . DESIGN R and omized single-blinded study . SETTING A teaching hospital . PARTICIPANTS Patients undergoing lung cancer resection ( N=24 ) . INTERVENTIONS Patients were r and omly assigned to receive PR ( strength and endurance training ) versus CPT ( breathing exercises for lung expansion ) . Both groups received educational classes . MAIN OUTCOME MEASURES Functional parameters assessed before and after 4 weeks of PR or CPT ( phase 1 ) , and pulmonary complications assessed after lung cancer resection ( phase 2 ) . RESULTS Twelve patients were r and omly assigned to the PR arm and 12 to the CPT arm . Three patients in the CPT arm were not su bmi tted to lung resection because of inoperable cancer . During phase 1 evaluation , most functional parameters in the PR group improved from baseline to 1 month : forced vital capacity ( FVC ) ( 1.47L [ 1.27 - 2.33L ] vs 1.71L [ 1.65 - 2.80L ] , respectively ; P=.02 ) ; percentage of predicted FVC ( FVC% ; 62.5 % [ 49%-71 % ] vs 76 % [ 65%-79.7 % ] , respectively ; P 6-minute walk test ( 425.5±85.3 m vs 475±86.5 m , respectively ; P maximal inspiratory pressure ( 90±45.9cmH(2)O vs 117.5±36.5cmH(2)O , respectively ; P and maximal expiratory pressure ( 79.7±17.1cmH(2)O vs 92.9±21.4cmH(2)O , respectively ; P lower incidence of postoperative respiratory morbidity ( P=.01 ) , a shorter length of postoperative stay ( 12.2±3.6d vs 7.8±4.8d , respectively ; P=.04 ) , and required a chest tube for fewer days ( 7.4±2.6d vs 4.5±2.9d , respectively ; P=.03 ) compared with the CPT arm . CONCLUSIONS These findings suggest that 4 weeks of PR before lung cancer resection improves preoperative functional capacity and decreases the postoperative respiratory morbidity ",
"BACKGROUND We planned to investigate the effect of preoperative short period intensive physical therapy on lung functions , gas-exchange , and capacity of diffusion , and ventilation-perfusion distribution of patients with non-small cell lung cancer . METHODS Sixty patients with lung cancer , who were deemed operable , were r and omly allocated into two groups . Intensive physical therapy was performed in patients in the study group before operation . Both groups received routine physical therapy after operation . RESULTS There was no difference in pulmonary function tests between the two groups . Intensive physical therapy statistically significantly increased peripheral blood oxygen saturation . At least one complication was noted in 5 patients ( 16.7 % ) in the control group , and 2 ( 6.7 % ) , in the study group . However , there was no statistically significant difference ( p = 0,4 ) . The hospital stay has been found to be statistically significantly shortened by intensive physical therapy ( p Ventilation-perfusion distribution was found to be significantly effected by intensive physical therapy . The change was prominent in the the contralateral lung ( p Intensive physical therapy appeared to increase oxygen saturation , reduce hospital stay , and change the ventilation/perfusion distribution . It had a significant , positive effect on the exercise capacity of patients",
"BACKGROUND Pulmonary rehabilitation ( PR ) is proposed as an effective strategy to decrease surgical morbidity . However , appropriate rehabilitation plan , initiation time , and optimal duration of PR remain unclear . Lung cancer patients with chronic obstructive pulmonary disease ( COPD ) are considered high-risk population for postoperative pulmonary complications ( PPCs ) because of poor lung fitness and cardiopulmonary endurance . This study aims to assess the impact of a one-week , systematic and highly-intensive rehabilitation on surgical lung cancer patients with mild to moderate COPD . METHODS A r and omized controlled trial with 48 subjects was conducted ( 24 patients each for the intervention and groups ) . The intervention group received seven days of systematic , integrated and highly-intensive PR before surgical treatment , including : pharmacotherapy with atomizing terbutaline , pulmicort and infusion of ambroxol ; and physical rehabilitation with respiratory training and endurance training . The control group underwent st and ard preoperative care . RESULTS For the intervention group , the postoperative length of stay was shorter [ ( 6.17±2.91 ) d vs ( 8.08±2.21 ) d ; P=0.013 ] ; likewise for the duration of antibiotics use [ ( 3.61±2.53 ) d vs ( 5.36±3.12 ) d ; P=0.032 ] . No significant difference was found between the groups in total in-hospital cost [ ( 46,455.6±5,080.9 ) ¥ vs ( 45,536.0±4,195.8 ) ¥ , P=0.498 ] , medicine cost [ ( 7,760.3±2,366.0 ) vs ( 6,993.0±2,022.5 ) , P=0.223 ] , and material cost [ ( 21,155.5±10,512.1 ) ¥ vs ( 21,488.8±3,470.6 ) ¥ , P=0.883 ] . In the intervention group , peak expiratory flow [ ( 268.40±123.94 ) L/min vs ( 343.71±123.92 ) L/min ; P ] , 6-min walk distance ( 6-MWD ) [ ( 595.42±106.74 ) m vs ( 620.90±99.27 ) m ; P=0.004 ] , and energy consumption [ ( 59.93±10.61 ) kcal vs ( 61.03±10.47 ) kcal ; P=0.004 ] were statistically different after the seven-day exercise , compared with those on the first day . Finally , for the intervention group the incidence of PPCs ( 8.3 % , 2/24 vs 20.8 % , 5/24 , 20.8 % ; P=0.416 ) were lower . CONCLUSIONS The systematic and highly-intensive pulmonary rehabilitation combining abdominal respiration training , respiratory exercise with incentive spirometry , and aerobic exercise could improve the cardiorespiratory endurance of lung cancer patients with mild to moderate COPD . The proposed program may be a practicable preoperative strategy .",
"Complete surgical resection is the most effective curative treatment for lung cancer . However , many patients with lung cancer also have severe COPD which increases their risk of postoperative complications and their likelihood of being considered \" inoperable . \" Preoperative pulmonary rehabilitation ( PR ) has been proposed as an intervention to decrease surgical morbidity but there is no established protocol and no r and omized study has been published to date . We tested two preoperative PR interventions in patients undergoing lung cancer resection and with moderate-severe COPD in a r and omized single blinded design . Outcomes were length of hospital stay and postoperative complications . The first study tested 4 weeks of guideline -based PR vs. usual care : that study proved to be very difficult to recruit as patients and providers were reluctant to delay surgery . Nine patients were r and omized and no differences were found between arms . The second study tested ten preoperative PR sessions using a customized protocol with nonst and ard components ( exercise prescription based on self efficacy , inspiratory muscle training , and the practice of slow breathing ) ( n=10 ) vs. usual care ( n=9 ) . The PR arm had shorter length of hospital stay by 3 days ( p=0.058 ) , fewer prolonged chest tubes ( 11 % vs. 63 % , p=0.03 ) and fewer days needing a chest tube ( 8.8 vs. 4.3 days p=0.04 ) compared to the controlled arm . A ten-session preoperative PR intervention may improve post operative lung reexpansion evidence d by shorter chest tube times and decrease the length of hospital stay , a crude estimator of post operative morbidity and costs . Our results suggest the potential for short term preoperative pulmonary rehabilitation interventions in patients with moderate-severe COPD undergoing curative lung resection . 4 weeks of conventional preoperative PR seems non feasible",
"OBJECTIVES The frequency and success rates of lung transplant in patients with end-stage lung disease are increasing . In our study , we investigated the effects of preoperative pulmonary rehabilitation on pulmonary function , exercise capacity , and quality of life in patients who are c and i date s for lung transplant . MATERIAL S AND METHODS This prospect i ve study included 39 consecutive patients who were c and i date s for lung transplant . All patients underwent preoperative pulmonary rehabilitation for at least 3 weeks . RESULTS Our patient group included 25 male and 14 female patients with a mean age of 36 years ( range , 15 -68 y ) . Although no significant improvement was shown in the forced expiratory volume in 1 second after pulmonary rehabilitation , significant improvements were observed in the Modified Medical Research Council dyspnea scores ( P = .001 ) and 6-minute walk distance ( P = .001 ) . We also observed statistically significant improvements in the Short-Form 36 Quality of Life Question naire 's physical function ( P = .01 ) and emotional role ( P = .02 ) subparameters . We also found a significant improvement in the Beck Depression Inventory score ( P = .004 ) . There was no correlation between Beck Depression Inventory scores before and after rehabilitation and 6-minute walk distance , Short-Form 36 , and Modified Medical Research Council dyspnea scores . CONCLUSIONS Our results suggest that preoperative pulmonary rehabilitation improves exercise capacity , reduces the sensation of dyspnea and muscle strength loss , and has a positive effect on the psychologic state of patients who are c and i date s for lung transplant",
"Background : Postoperative respiratory complications often arise in lung cancer patients after lung resection , although these are often difficult to predict . We sought to identify reliable predictors of early-onset postoperative respiratory complications in lung cancer patients who had moderate-to-severe preoperative respiratory impairment . Methods : This was a prospect i ve observational study that included 107 consecutive lung cancer patients with forced expiratory volume in 1 s thoracotomy and lung resection . Preoperative functional assessment s included pulmonary function testing by spirometry , single breath diffusion capacity of lung for carbon monoxide , and cardiopulmonary exercise testing . Risk factors for early-onset postoperative respiratory complications that occurred within 30 days postoperatively were sought from among these pulmonary function testing and cardiopulmonary exercise testing results . Results : By multivariable logistic regression , peak oxygen uptake ( V′O2max% ; p the transcutaneous pulse oxygen saturation difference during load exercise ( ΔSPO2 % ; p probability of postoperative respiratory complications was P complication = e ( 2 . 58 − 0 . 08 V ′ O 2 max % + 0 . 56 Δ SP O 2 % ) / [ 1 + e ( 2 . 58 − 0 . 08 V ′ O 2 max % + 0 . 56 Δ SP O 2 % ) ] . Pcomplication ≥ 0.202 for postoperative respiratory complications had a sensitivity of 80.8 % and a specificity of 81.5 % . Conclusions : For lung cancer patients with forced expiratory volume in 1 s 60 % of predicted , in addition to common preoperative tests , V′O2max% and ΔSPO2 % may be an aid for predicting early-onset postoperative respiratory complications ",
"OBJECTIVES Peak VO2 , as measure of physical performance is central to a correct preoperative evaluation in patients with both non-small-cell lung cancer ( NSCLC ) and chronic obstructive pulmonary disease ( COPD ) because it is closely related both to operability criteria and the rate of postoperative complications . Strategies to improve peak VO2 , as a preoperative pulmonary rehabilitation programme ( PRP ) , should be considered favourably in these patients . In order to clarify the role of pulmonary rehabilitation , we have evaluated the effects of 3-week preoperative high-intensity training on physical performance and respiratory function in a group of patients with both NSCLC and COPD who underwent lobectomy . METHODS We studied 40 patients with both NSCLC and COPD , age Patients were r and omly divided into two groups ( R and S ) : Group R underwent an intensive preoperative PRP , while Group S underwent only lobectomy . We evaluated peak VO2 in all patients at Time 0 ( T0 ) , after PRP/before surgery in Group R/S ( T1 ) and 60 days after surgery , respectively , in both groups ( T2 ) . RESULTS There was no difference between groups in peak VO2 at T0 , while a significant difference was observed both at T1 and T2 . In Group R , peak VO2 improves significantly from T0 to T1 : 14.9 ± 2.3 - 17.8 ± 2.1 ml/kg/min ± st and ard deviation ( SD ) , P S peak VO2 did not change from T0 to T1 and significantly deteriorates from T1 to T2 : 14.5 ± 1.2 - 11.4 ± 1.2 ml/kg/min ± SD , P CONCLUSIONS PRP was a valid preoperative strategy to improve physical performance in patients with both NSCLC and COPD and this advantage was also maintained after surgery",
"AIMS AND OBJECTIVES To examine the effects of an early postoperative walking exercise programme on postlobectomy lung cancer patients . BACKGROUND Few interventional studies on the postoperative health status of lung cancer patients have considered the efficacy of programmes design ed to improve critical health variables . DESIGN A two-group quasi-experimental , longitudinal approach repeated four times examined participant data collected 12 - 18 hours prior to surgery and again at one , three and six months after surgery . METHODS We assigned the first 33 enrolled participants to the intervention group and the second 33 to the control group . The intervention was a daily supervised walking exercise programme consisting of 12 weeks of brisk walking exercise that began on the day following transfer to the regular ward along with weekly telephone calls until 12 weeks after discharge . Health status was measured using a structured question naire ( World Health Organization Quality of Life , brief version ) and clinical tests ( pulmonary function test and 6-minute walk test ) . We analysed data using general estimating equations , with p group pulmonary and physical functions were increasingly better over time than those of the control group , with no significant difference in quality of life between the two groups . Compared to the control group , the intervention group earned significantly better values for FVC% at postoperative month 3 and for FEV1 % at postoperative months 3 and 6 . Intervention group 6MWT scores were significantly better than those of the control group at postoperative months 1 , 3 and 6 . CONCLUSION This study demonstrated the benefits of an early postoperative walking exercise intervention for pulmonary and physical function in postlobectomy lung cancer patients . RELEVANCE TO CLINICAL PRACTICE The results may guide the design of appropriate interventions in the future . Clinical trials in other population s are needed to confirm the results of this study",
"Introduction . Surgical resection in patients with non – small cell lung cancer ( NSCLC ) may be associated with significant morbidity , functional limitations , and decreased quality of life . Objectives . The safety and feasibility of a preoperative and early postoperative rehabilitation program in patients operated for NSCLC was determined in a nonhospital setting , with focus on high-intensity interval exercise . Methods . Forty patients with biopsy-proven NSCLC stages I to IIIa referred for surgical resection at the Department of Cardiothoracic Surgery RT , Rigshospitalet , University of Copenhagen , were r and omly assigned to 1 of 4 groups ( 3 intervention groups and 1 control group ) . The preoperative intervention consisted of a home-based exercise program , while the postoperative exercise program comprised a supervised group exercise program involving resistance and high-intensity interval cardiorespiratory exercise 2 hours weekly for 12 weeks combined with individual counseling . The study endpoints were inclusion rate , adherence , and number of adverse events . Results . Forty patients ( of 124 screened ; 32 % ) were included and r and omized into the 4 groups . The postoperative exercise was completed by 73 % of the patients r and omized to this intervention . No adverse events were observed , indicating that the early postoperative exercise program is safe . The preoperative home-based exercise program was not feasible due to interfering diagnostic procedures and fast-track surgery that left only 1 to 2 weeks between diagnosis and surgery . Conclusion . The early postoperative exercise program for patients with NSCLC was safe and feasible , but in a fast-track set up , a preoperative home-based exercise program was not feasible for this population"
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Gastric cancer is the fifth malignancy and the third cause of cancer death worldwide , according to the global cancer statistics presented in 2018 . Its definition and staging have been revised in the eight edition of the AJCC/TNM classification , which took effect in 2018 . Novel molecular classifications for GC have been recently established and the process of translating these classifications into clinical practice is ongoing . The cornerstone of GC treatment is surgical , in a context of multimodal therapy . Surgical treatment is being st and ardized , and is evolving according to new anatomical concepts and to the recent technological developments . This is leading to a massive improvement in the use of mini-invasive techniques . Mini-invasive techniques aim to be equivalent to open surgery from an oncologic point of view , with better short-term outcomes . The persecution of better short-term outcomes also includes the optimization of the perioperative management , which is being implemented on large scale according to the enhanced recovery after surgery principles . In the era of precision medicine , multimodal treatment is also evolving . The long-time-awaited results of many trials investigating the role for preoperative and postoperative management have been published , changing the clinical practice . Novel investigations focused both on traditional chemotherapeutic regimens and targeted therapies are currently ongoing . Modern platforms increase the possibility for further st and ardization of the different treatments , promote the use of big data and open new possibilities for surgical learning . This systematic review in two parts assesses all the current up date s in GC treatment
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"BACKGROUND VEGFR-2 has a role in gastric cancer pathogenesis and progression . We assessed whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel . METHODS This r and omised , placebo-controlled , double-blind , phase 3 trial was done at 170 centres in 27 countries in North and South America , Europe , Asia , and Australia . Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline ) were r and omly assigned with a central ised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15 , plus paclitaxel 80 mg/m(2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle . A permuted block r and omisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used . The primary endpoint was overall survival . Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug . This trial is registered with Clinical Trials.gov , number NCT01170663 , and has been completed ; patients who are still receiving treatment are in the extension phase . FINDINGS Between Dec 23 , 2010 , and Sept 23 , 2012 , 665 patients were r and omly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel . Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median 9·6 months [ 95 % CI 8·5 - 10·8 ] vs 7·4 months [ 95 % CI 6·3 - 8·4 ] , hazard ratio 0·807 [ 95 % CI 0·678 - 0·962 ] ; p=0·017 ) . Grade 3 or higher adverse events that occurred in more than 5 % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel included neutropenia ( 133 [ 41 % ] of 327 vs 62 [ 19 % ] of 329 ) , leucopenia ( 57 [ 17 % ] vs 22 [ 7 % ] ) , hypertension ( 46 [ 14 % ] vs eight [ 2 % ] ) , fatigue ( 39 [ 12 % ] vs 18 [ 5 % ] ) , anaemia ( 30 [ 9 % ] vs 34 [ 10 % ] ) , and abdominal pain ( 20 [ 6 % ] vs 11 [ 3 % ] ) . The incidence of grade 3 or higher febrile neutropenia was low in both groups ( ten [ 3 % ] vs eight [ 2 % ] ) . INTERPRETATION The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new st and ard second-line treatment for patients with advanced gastric cancer . FUNDING Eli Lilly and Company",
"Purpose Many surgeons in Japan use 1-day nasogastric tube ( NGT ) decompression after gastrectomy as a st and ard procedure . This prospect i ve r and omized study aim ed to define whether 1-day NGT decompression is necessary after distal gastrectomy . Methods The subjects were 233 patients with gastric cancer , r and omized into two groups immediately after distal gastrectomy : one group received 1-day NGT decompression ( NGT group , n = 119 ) and the other did not ( no-NGT group , n = 114 ) . The primary outcome measure was postoperative surgery-related and respiratory complications , whereas secondary measures were the postoperative course to recovery and patient complaints . Results The incidence of surgery-related complications did not differ significantly between the NGT and no-NGT groups ( 21.0 and 19.2 % , respectively ; p = 0.87 ) . The rate of respiratory complications was 6.7 % in the NGT group and 7.0 % in the no-NGT group ( p > 0.99 ) . The time to passage of first flatus and the postoperative hospital stay did not differ between the groups . Twenty-five patients in the NGT group and none in the no-NGT group complained of nasopharyngeal discomfort ( p NGT , we believe that routine 1-day NGT decompression is unnecessary after distal gastrectomy",
"Adjuvant chemotherapy aims to eradicate residual micro-metastatic tumor cells existing at distant sites outside the surgical field . The current st and ard adjuvant chemotherapy is S-1 for 1 year or capecitabine plus oxaliplatin for 6 months after D2 gastrectomy . However , there are some rooms in the overall survival of Stage III . Neoadjuvant chemotherapy(NAC)is a promising approach that combines intensive chemotherapy with high compliance ; however , it is under development in Japan . Two JCOG phase II trials suggested that NAC was effective for bulky nodal disease . For scirrhous-type malignancy , a JCOG phase III trial is currently ongoing investigating the efficacy of a NAC regimen of S-1 plus CDDP . Another group is conducting 2 r and omized phase II trials to compare different regimens and courses of NAC . So far , 2 courses of S-1 plus CDDP or 3 courses of S-1 plus oxaliplatin can be recommended as c and i date s for the test arm of future phase III studies of NAC",
"PURPOSE We evaluated the activity of regorafenib , an oral multikinase inhibitor , in advanced gastric adenocarcinoma . PATIENTS AND METHODS We conducted an international ( Australia and New Zeal and , South Korea , and Canada ) r and omized phase II trial in which patients were r and omly assigned at a two-to-one ratio and stratified by lines of prior chemotherapy for advanced disease ( one v two ) and region . Eligible patients received best supportive care plus regorafenib 160 mg or matching placebo orally on days 1 to 21 of each 28-day cycle until disease progression or prohibitive adverse events occurred . The primary end point was progression-free survival ( PFS ) . Final analysis included data to December 31 , 2014 . RESULTS A total of 152 patients were r and omly assigned from November 7 , 2012 , to February 25 , 2014 , yielding 147 evaluable patients ( regorafenib , n = 97 ; placebo , n = 50 ) . Baseline characteristics were balanced . Median PFS significantly differed between groups ( regorafenib , 2.6 months ; 95 % CI , 1.8 to 3.1 and placebo , 0.9 months ; 95 % CI , 0.9 to 0.9 ; hazard ratio [ HR ] , 0.40 ; 95 % CI , 0.28 to 0.59 ; P of chemotherapy , peritoneal metastasis presence , number of metastatic sites , and plasma vascular endothelial growth factor A. A survival trend in favor of regorafenib was seen ( median , 5.8 months ; 95 % CI , 4.4 to 6.8 v 4.5 months ; 95 % CI , 3.4 to 5.2 ; HR , 0.74 ; P = .147 ) . Twenty-nine patients assigned to placebo received open-label regorafenib after disease progression . Regorafenib toxicity was similar to that previously reported . CONCLUSION In this phase II trial , regorafenib was effective in prolonging PFS in refractory advanced gastric adenocarcinoma . Regional differences were found , but regorafenib was effective in both regional groups . A phase III trial is planned",
"Background The feasibility of the use of the enhanced recovery after surgery ( ERAS ) protocol in patients with gastric cancer remains unclear . Methods This study was a single-center , prospect i ve r and omized trial involving patients with gastric cancer undergoing curative gastrectomy . The primary end point was the length of postoperative hospital stay . Secondary end points were the postoperative complication rate , admission costs , weight loss , and amount of physical activity . Results From July 2013 to June 2015 , we r and omized 148 patients into an ERAS protocol group ( n = 73 ) and a conventional protocol group ( n = 69 ) ; six patients withdrew from the study . The hospital stay was significantly shorter in the ERAS protocol group than in the conventional protocol group ( 9 days vs 10 days ; P = 0.037 ) . The ERAS protocol group had a significantly lower rate of postoperative complications of grade III or higher ( 4.1 % vs 15.4 % ; P = 0.042 ) and reduced costs of hospitalization ( JPY 1,462,766 vs JPY 1,493,930 ; P = 0.045 ) . The ratio of body weight to preoperative weight at 1 week and 1 month after the operation was higher in the ERAS protocol group ( 0.962 vs 0.957 , P = 0.020 , and 0.951 vs 0.937 , P = 0.021 , respectively ) . The ERAS protocol group recorded more physical activity in the first week after surgery . Conclusions The ERAS protocol is safe and efficient , and seems to improve the postoperative course of patients with gastric cancer",
"Background A dramatic increase in the incidence of the diffuse form of gastric adenocarcinomas and particularly signet ring cell carcinomas has been observed in Western countries . Evidence is accruing that signet ring cell carcinomas may have inherent chemo resistance leaving many clinicians unsure of the benefits of delaying surgery to pursue a neoadjuvant approach . Methods / design PRODIGE-19-FFCD1103-ADCI002 is a prospect i ve multicentre controlled r and omised phase II/III trial comparing current st and ard of care of perioperative chemotherapy ( 2x3 cycles of Epirubicin , cisplatin , 5-fluorouracil ) with a strategy of primary surgery followed by adjuvant chemotherapy ( 6 cycles of Epirubicin , cisplatin , 5-fluorouracil ) in patients with a stage IB-III gastric signet ring cell tumour . The principal objective of the phase II study ( 84 patients ) is to determine if the experimental arm ( primary surgery followed by adjuvant chemotherapy ) has sufficient interest in terms of percentage of living patients at 24 months to be evaluated in a phase III trial . If 7 or less patients in the experimental arm are alive at 24 months , phase III will not be initiated . The primary objective of phase III ( 230 additional patients ) is to demonstrate superiority of the experimental arm in terms of overall survival . Secondary endpoints include overall survival at 36 months , disease free survival at 24 and 36 months , R0 resection rates , treatment tolerance , postoperative mortality and morbidity evaluated by Clavien-Dindo severity index , the prognostic impact of positive peritoneal cytology and the assessment of quality of life . An ancillary study will assess the emotional and cognitive impact of surgery and perioperative chemotherapy for both the patient and their partner . Discussion As inherent chemo resistance of signet ring cell tumours and delay in definitive surgery may favour tumour progression we hypothesise that a policy of primary surgery followed by adjuvant chemotherapy will improve overall survival compared to a st and ard perioperative chemotherapeutic strategy . This r and omised phase II/III trial is the first dedicated to this histological subtype . Whilst the development of new biomarkers and targeted therapies are awaited , the results of this trial should further help in devising individualised protocol s of patient care in a tumour group whose diversity increasingly dem and s assessment of alternative strategies . Trial registration Clinical Trials.gov ,",
"Background While the incidence of esophageal and gastric cancers is increasing , the prognosis of these cancers remains bleak . Endoscopy and surgery are the st and ard treatments for localized tumors , but multimodal treatments , associated chemotherapy , targeted therapies , immunotherapy , radiotherapy , and surgery are needed for the vast majority of patients who present with locally advanced or metastatic disease at diagnosis . Although survival has improved , most patients still present with advanced disease at diagnosis . In addition , most patients exhibit a poor or incomplete response to treatment , experience early recurrence and have an impaired quality of life . Compared with several other cancers , the therapeutic approach is not personalized , and research is much less developed . It is , therefore , urgent to hasten the development of research protocol s , and consequently , develop a large , ambitious and innovative tool through which future scientific questions may be answered . This research must be patient-related so that rapid feedback to the bedside is achieved and should aim to identify clinical - , biological- and tumor-related factors that are associated with treatment resistance . Finally , this research should also seek to explain epidemiological and social facets of disease behavior . Methods The prospect i ve FREGAT data base , established by the French National Cancer Institute , is focused on adult patients with carcinomas of the esophagus and stomach and on whatever might be the tumor stage or therapeutic strategy . The data base includes epidemiological , clinical , and tumor characteristics data as well as follow-up , human and social sciences quality of life data , along with a tumor and serum bank . Discussion This innovative method of research will allow for the banking of millions of data for the development of excellent basic , translational and clinical research programs for esophageal and gastric cancer . This will ultimately improve general knowledge of these diseases , therapeutic strategies and patient survival . This data base was initially developed in France on a nationwide basis , but currently , the data base is available for worldwide contributions with respect to the input of patient data or the request for data for scientific projects . Trial registration The FREGAT data base has a dedicated website ( www.fregat- data base.org ) and is registered on the Clinical trials.gov site , number NCT 02526095 , since August 8 , 2015",
"BACKGROUND Docetaxel-based chemotherapy is effective in metastatic gastric and gastro-oesophageal junction adenocarcinoma , but has not yet been evaluated in the context of resectable patients . Here we report findings from the phase 2 part of the phase 2/3 FLOT4 trial , which compared histopathological regression in patients treated with a docetaxel-based triplet chemotherapy versus an anthracycline-based triplet chemotherapy before surgical resection . METHODS In this r and omised , open-label , phase 2/3 study , eligible participants were recruited from 28 German oncology centres . Patients with resectable gastric or gastro-oesophageal junction cancer who had clinical stage cT2 or higher , nodal positive ( cN+ ) disease , or both were r and omly assigned ( 1:1 ) to either three preoperative and three postoperative 3-week cycles of intravenous epirubicin 50 mg/m2 on day 1 , intravenous cisplatin 60 mg/m2 on day 1 , and either fluorouracil 200 mg/m2 as continuous intravenous infusion or capecitabine 1250 mg/m2 orally ( two doses of 625 mg/m2 per day ) on days 1 to 21 ( ECF/ECX group ) or four preoperative and four postoperative 2-week cycles of docetaxel 50 mg/m2 , intravenous oxaliplatin 85 mg/m2 , intravenous leucovorin 200 mg/m2 , and fluorouracil 2600 mg/m2 as a 24 h infusion , all on day 1 ( FLOT group ) . R and omisation was done central ly with an interactive web-response system based on a sequence generated with blocks ( block size 2 ) stratified by Eastern Cooperative Oncology Group performance status , location of primary tumour , age , and nodal status . No masking was done . Central assessment of pathological regression was done according to the Becker criteria . The primary endpoint was pathological complete regression ( tumour regression grade TRG1a ) and was analysed in the modified intention-to-treat population , defined as all patients who were r and omly assigned to treatment excluding patients who had surgery but did not provide resection specimens for central evaluation . The study ( including the phase 3 part ) has completed enrolment , but follow-up is ongoing and this is an interim analysis . The trial is registered with Clinical Trials.gov , number NCT01216644 . FINDINGS Between Aug 18 , 2010 , and Aug 10 , 2012 , 300 patients ( 152 patients in the ECF/ECX group ; 148 patients in the FLOT group ) were enrolled into the phase 2 part of the study , 265 of whom ( 137 in the ECF/ECX group ; 128 in the FLOT group ) were assessable on a modified intention-to-treat basis . 119 ( 93 % ) of 128 patients in the FLOT group and 126 ( 92 % ) of 137 patients in the ECF/ECX group were given all planned preoperative cycles of treatment . FLOT was associated with significantly higher proportions of patients achieving pathological complete regression than was ECF/ECX ( 20 [ 16 % ; 95 % CI 10 - 23 ] of 128 patients vs eight [ 6 % ; 3 - 11 ] of 137 patients ; p=0·02 ) . 44 ( 40 % ) of 111 patients in the ECF/ECX group and 30 ( 25 % ) of 119 patients in the FLOT group had at least one serious adverse event involving a perioperative medical or surgical complication . The most common non-surgical grade 3 - 4 adverse events were neutropenia ( 52 [ 38 % ] of 137 patients in the ECF/ECX group vs 67 [ 52 % ] of 128 patients in the FLOT group ) , leucopenia ( 28 [ 20 % ] vs 36 [ 28 % ] ) , nausea ( 23 [ 17 % ] vs 12 [ 9 % ] ) , infection ( 16 [ 12 % ] vs 15 [ 12 % ] ) , fatigue ( 19 [ 14 % ] vs 11 [ 9 % ] ) , and vomiting ( 13 [ 10 % ] vs four [ 3 % ] ) . INTERPRETATION Perioperative FLOT was active and feasible to administer , and might represent an option for patients with locally advanced , resectable gastric or gastro-eosophageal junction adenocarcinoma . FUNDING None",
"Background Neoadjuvant therapy is increasingly the st and ard of care in the management of locally advanced adenocarcinoma of the oesophagus and junction ( AEG ) . In r and omised controlled trials ( RCTs ) , the MAGIC regimen of pre- and postoperative chemotherapy , and the CROSS regimen of preoperative chemotherapy combined with radiation , were superior to surgery only in RCTs that included AEG but were not powered on this cohort . No completed RCT has directly compared neoadjuvant or perioperative chemotherapy and neoadjuvant chemoradiation . The Neo-AEGIS trial , uniquely powered on AEG , and including comprehensive modern staging , compares both these regimens . Methods This open label , multicentre , phase III RCT r and omises patients ( cT2 - 3 , N0 - 3 , M0 ) in a 1:1 fashion to receive CROSS protocol ( Carboplatin and Paclitaxel with concurrent radiotherapy , 41.4Gy/23Fr , over 5 weeks ) . The power calculation is a 10 % difference in favour of CROSS , powered at 80 % , two-sided alpha level of 0.05 , requiring 540 patients to be evaluable , 594 to be recruited if a 10 % dropout is included ( 297 in each group ) . The primary endpoint is overall survival , with a minimum 3-year follow up . Secondary endpoints include : disease free survival , recurrence rates , clinical and pathological response rates , toxicities of induction regimens , post-operative pathology and tumour regression grade , operative in-hospital complications , and health-related quality of life . The trial also affords opportunities for establishing a bio-re source of pre-treatment and resected tumour , and translational research . Discussion This RCT directly compares two established treatment regimens , and addresses whether radiation therapy positively impacts on overall survival compared with a st and ard perioperative chemotherapy regimen Sponsor : Irish Clinical Research Group (ICORG).Trial registration NCT01726452 . Protocol 10 - 14 . Date of registration 06/11/2012",
"Background Recent r and omized controlled trials comparing neoadjuvant chemoradiation plus surgery or perioperative chemotherapy plus surgery with surgery alone showed significant survival benefits for combined modality treatment of patients with localized esophageal adenocarcinoma . However , head-to-head comparisons of neoadjuvant chemoradiation and perioperative chemotherapy applying contemporary treatment protocol s are lacking . The present trial was initiated to obtain valid information whether neoadjuvant chemoradiation or perioperative chemotherapy yields better survival in the treatment of localized esophageal adenocarcinoma . Methods / design The ESOPEC trial is an investigator-initiated multicenter prospect i ve r and omized controlled two-arm trial , comparing the efficacy of neoadjuvant chemoradiation ( CROSS protocol : 41.4Gy plus carboplatin/paclitaxel ) followed by surgery versus perioperative chemotherapy and surgery ( FLOT protocol : 5-FU/leucovorin/oxaliplatin/docetaxel ) for the curative treatment of localized esophageal adenocarcinoma . Patients with cT1cN + cM0 and cT2 - 4acNxcM0 esophageal and junctional adenocarcinoma are eligible . The trial aims to include 438 participants who are central ly r and omized to one of the two treatment groups in a 1:1 ratio stratified by N-stage and study site . The primary endpoint of the trial is overall survival assessed with a minimum follow-up of 36 months . Secondary objectives are progression-free survival , recurrence-free survival , site of failure , postoperative morbidity and mortality , duration of hospitalization as well as quality of life . Discussion The ESOPEC trial compares perioperative chemotherapy according to the FLOT protocol to neoadjuvant chemoradiation according to the CROSS protocol in multimodal treatment of non-metastasized recectable adenocarcinoma of the esophagus and the gastroesophageal junction . The goal of the trial is identify the superior protocol with regard to patient survival , treatment morbidity and quality of life . Trial registration NCT02509286 ( July 22 , 2015",
"Background Artificial neural networks ( ANNs ) have been applied to many prediction and classification problems , and could also be used to develop a prediction model of survival outcomes for cancer patients . Objective The aim of this study is to develop a prediction model of survival outcomes for patients with gastric cancer using an ANN . Methods This study enrolled 1243 patients with stage IIA – IV gastric cancer who underwent D2 gastrectomy from January 2007 to June 2010 . We used a recurrent neural network ( RNN ) to make the survival recurrent network ( SRN ) , and patients were r and omly sorted into a training set ( 80 % ) and a test set ( 20 % ) . Fivefold cross-validation was performed with the training set , and the optimized model was evaluated with the test set . Receiver operating characteristic ( ROC ) curves and area under the curves ( AUCs ) were evaluated , and we compared the survival curves of the American Joint Committee on Cancer ( AJCC ) 8th stage groups with those of the groups classified by the SRN-predicted survival probability . Results The test data showed that the ROC AUC of the SRN was 0.81 at the fifth year . The SRN-predicted survival corresponded closely with the actual survival in the calibration curve , and the survival outcome could be more discriminately classified by using the SRN than by using the AJCC staging system . ConclusionS RN was a more powerful tool for predicting the survival rates of gastric cancer patients than conventional TNM staging , and may also provide a more flexible and exp and able method when compared with fixed prediction models such as nomograms",
"BACKGROUND Enhanced recovery programs have become an important focus of perioperative management . A few studies have demonstrated the efficacy of an enhanced recovery after surgery ( ERAS , which includes optimized pain control , restricted I.V. fluids , early initiation of postoperative oral feeding , and enforced mobilization ) protocol in patients undergoing radical gastrectomy . We investigated the feasibility and safety of laparoscopic radical gastrectomy within ERAS programs . METHODS In this single-center prospect i ve r and omized controlled trial conducted between September 2013 and August 2014 , 149 consecutive locally advanced gastric cancer patients ( T2 - 4 , any N , M0 ) diagnosed by the CT scanning were allocated to either ERAS group ( N = 73 ) or conventional pathway group ( N = 76 ) . The same surgical technique was used in both groups , that is , laparoscopic gastrectomy with D2 lymphadenectomy and R0 resection . Intergroup differences were evaluated for clinical parameters and C-reactive protein for testing tissue injury . RESULTS ERAS combined with laparoscopic gastrectomy was observed in our study . Recovery parameters such as time to return to normal diet ( days ) 1.90 ± 0.71 versus 3.52 ± 0.81 , P = .003 and time to the first defecation ( days ) 2.97 ± 1.23 versus 5.20 ± 1.81 , P = .015 were measured . The post hospital stay ( days ) in ERAS and the conventional care group were 6.38 ± 2.04 and 8.62 ± 2.87 , P terms of postoperative complications and C-reactive protein levels . One patient in the ERAS group was readmitted because of anastomotic leakage . No instances of deaths were reported during the 30-day follow-up period . CONCLUSION This study demonstrates the feasibility and safety of ERAS protocol in advanced gastric cancer patients undergoing laparoscopic radical gastrectomy and was associated with shorter duration of hospital stay . ( Clinical trials.gov Identifier No NCT02348229 )",
"BACKGROUND Both perioperative chemotherapy and postoperative chemoradiotherapy improve survival in patients with resectable gastric cancer from Europe and North America . To our knowledge , these treatment strategies have not been investigated in a head to head comparison . We aim ed to compare perioperative chemotherapy with preoperative chemotherapy and postoperative chemoradiotherapy in patients with resectable gastric adenocarcinoma . METHODS In this investigator-initiated , open-label , r and omised phase 3 trial , we enrolled patients aged 18 years or older who had stage IB- IVA resectable gastric or gastro-oesophageal adenocarcinoma ( as defined by the American Joint Committee on Cancer , sixth edition ) , with a WHO performance status of 0 or 1 , and adequate cardiac , bone marrow , liver , and kidney function . Patients were enrolled from 56 hospitals in the Netherl and s , Sweden , and Denmark , and were r and omly assigned ( 1:1 ) with a computerised minimisation programme with a r and om element to either perioperative chemotherapy ( chemotherapy group ) or preoperative chemotherapy with postoperative chemoradiotherapy ( chemoradiotherapy group ) . R and omisation was done before patients were given any preoperative chemotherapy treatment and was stratified by histological subtype , tumour localisation , and hospital . Patients and investigators were not masked to treatment allocation . Surgery consisted of a radical resection of the primary tumour and at least a D1 + lymph node dissection . Postoperative treatment started within 4 - 12 weeks after surgery . Chemotherapy consisted of three preoperative 21-day cycles and three postoperative cycles of intravenous epirubicin ( 50 mg/m2 on day 1 ) , cisplatin ( 60 mg/m2 on day 1 ) or oxaliplatin ( 130 mg/m2 on day 1 ) , and capecitabine ( 1000 mg/m2 orally as tablets twice daily for 14 days in combination with epirubicin and cisplatin , or 625 mg/m2 orally as tablets twice daily for 21 days in combination with epirubicin and oxaliplatin ) , received once every three weeks . Chemoradiotherapy consisted of 45 Gy in 25 fractions of 1·8 Gy , for 5 weeks , five daily fractions per week , combined with capecitabine ( 575 mg/m2 orally twice daily on radiotherapy days ) and cisplatin ( 20 mg/m2 intravenously on day 1 of each 5 weeks of radiation treatment ) . The primary endpoint was overall survival , analysed by intention-to-treat . The CRITICS trial is registered at Clinical Trials.gov , number NCT00407186 ; EudraCT , number 2006 - 004130 - 32 ; and CKTO , 2006 - 02 . FINDINGS Between Jan 11 , 2007 , and April 17 , 2015 , 788 patients were enrolled and r and omly assigned to chemotherapy ( n=393 ) or chemoradiotherapy ( n=395 ) . After preoperative chemotherapy , 372 ( 95 % ) of 393 patients in the chemotherapy group and 369 ( 93 % ) of 395 patients in the chemoradiotherapy group proceeded to surgery , with a potentially curative resection done in 310 ( 79 % ) of 393 patients in the chemotherapy group and 326 ( 83 % ) of 395 in the chemoradiotherapy group . Postoperatively , 233 ( 59 % ) of 393 patients started chemotherapy and 245 ( 62 % ) of 395 started chemoradiotherapy . At a median follow-up of 61·4 months ( IQR 43·3 - 82·8 ) , median overall survival was 43 months ( 95 % CI 31 - 57 ) in the chemotherapy group and 37 months ( 30 - 48 ) in the chemoradiotherapy group ( hazard ratio from stratified analysis 1·01 ( 95 % CI 0·84 - 1·22 ; p=0·90 ) . After preoperative chemotherapy , in the total safety population of 781 patients ( assessed together ) , there were 368 ( 47 % ) grade 3 adverse events ; 130 ( 17 % ) grade 4 adverse events , and 13 ( 2 % ) deaths . Causes of death during preoperative treatment were diarrhoea ( n=2 ) , dihydropyrimidine deficiency ( n=1 ) , sudden death ( n=1 ) , cardiovascular events ( n=8 ) , and functional bowel obstruction ( n=1 ) . During postoperative treatment , grade 3 and 4 adverse events occurred in 113 ( 48 % ) and 22 ( 9 % ) of 233 patients in the chemotherapy group , respectively , and in 101 ( 41 % ) and ten ( 4 % ) of 245 patients in the chemoradiotherapy group , respectively . Non-febrile neutropenia occurred more frequently during postoperative chemotherapy ( 79 [ 34 % ] of 233 ) than during postoperative chemoradiotherapy ( 11 [ 4 % ] of 245 ) . No deaths were observed during postoperative treatment . INTERPRETATION Postoperative chemoradiotherapy did not improve overall survival compared with postoperative chemotherapy in patients with resectable gastric cancer treated with adequate preoperative chemotherapy and surgery . In view of the poor postoperative patient compliance in both treatment groups , future studies should focus on optimising preoperative treatment strategies . FUNDING Dutch Cancer Society , Dutch Colorectal Cancer Group , and Hoffmann-La Roche",
"Purpose The aim of this phase II study was to perform neoadjuvant hyperthermic intraperitoneal chemoperfusion ( HIPEC ) via a minimally invasive approach without cytoreduction for patients with gastric cancer and positive peritoneal cytology or low-volume peritoneal carcinomatosis . Methods Patients with gastric or gastroesophageal adenocarcinoma and positive peritoneal cytology or radiologically occult peritoneal carcinomatosis after systemic chemotherapy received laparoscopic HIPEC with mitomycin C 30 mg and cisplatin 200 mg . Patients whose peritoneal disease resolved were offered gastrectomy . The primary endpoint was overall survival ( OS ) , with secondary endpoints of HIPEC complications and gastrectomy rate . Results We enrolled 19 patients ( 6 with positive peritoneal cytology only and 13 with peritoneal carcinomatosis ) and treated them with 38 laparoscopic HIPEC procedures . Patients had received a median of 8 cycles ( range 3–12 ) of systemic chemotherapy prior to enrollment . Fourteen patients were also treated with chemoradiotherapy before or between cycles of HIPEC . The complication rate for HIPEC was 11 % ( 4 of 38 procedures ) , the 30-day mortality rate was 0 % , and the median length of hospital stay after HIPEC was 3 days ( range 2–6 ) . Five patients went on to receive gastrectomy . The median follow-up was 18.9 months , the median OS from the date of diagnosis of metastatic disease was 30.2 months , and the median OS from the first laparoscopic HIPEC was 20.3 months . Conclusions Laparoscopic HIPEC was well tolerated , and an encouraging number of patients demonstrated an absence of peritoneal disease after HIPEC and were able to undergo gastrectomy . Comparative studies will be required to clarify survival benefits",
"Background We sought to determine the sites of recurrence and identify predicting factors for recurrence and survival in patients who underwent gastrectomy for adenocarcinoma at an institution where preoperative therapy is commonly used for advanced gastric cancer . Methods We collected clinicopathologic data and sites of recurrence from a prospect ively maintained data base of patients who underwent potentially curative resection of gastric or gastroesophageal adenocarcinoma at our institution in 1995–2014 , and we assessed associations between these characteristics and recurrence patterns and survival . Results We identified 488 patients who underwent R0 resection of localized gastric cancer . The median age was 63 years ( interquartile range 53–71 years ) , and 60 % were male . The most common T and N categories , per endoscopic ultrasonography , were T3 ( 58 % ) and N0 ( 61 % ) . Preoperative treatment was used in 61 % of patients . A total of 125 ( 26 % ) patients experienced recurrence during follow-up . Recurrences were locoregional in 19 patients ( 15 % ) , peritoneal in 61 ( 49 % ) , and nonperitoneal distant in 67 ( 54 % ) . The peritoneum also was the most common organ of recurrence ( 49 % ) , followed by the liver ( 21 % ) . The median time from primary resection to recurrence was 2.7 years for locoregional , 1.3 years for peritoneal , and 0.6 years for nonperitoneal distant recurrence ( p = 0.01 ) . Median overall survival was markedly shorter after peritoneal and nonperitoneal distant recurrences than after locoregional recurrences . Conclusions The peritoneum was a common site of recurrence after curative resection of gastric cancer and was associated with poor survival . Prophylactic treatment targeting the peritoneal cavity might improve survival of advanced gastric cancer",
"Background In Europe , gastric cancer remains diagnosed at advanced stage ( serosal and /or lymph node involvement ) . Despite curative management combining perioperative systemic chemotherapy and gastrectomy with D1-D2 lymph node dissection , 5-year survival rates of T3 and /or N + patients remain under 30 % . More than 50 % of recurrences are peritoneal and /or locoregional . The use of adjuvant hyperthermic intraperitoneal chemotherapy that eliminates free cancer cells that can be released into peritoneal cavity during the gastrectomy and prevents peritoneal carcinomatosis recurrences , was extensively evaluated by several r and omized trials conducted in Asia . Two meta- analysis reported that adjuvant hyperthermic intraperitoneal chemotherapy significantly reduces the peritoneal recurrences and significantly improves the overall survival . As it was previously done for the evaluation of the extension of lymph node dissection , it seems very important to vali date on European or caucasian patients the results observed in trials performed in Asia . Methods / design GASTRICHIP is a prospect i ve , open , r and omized multicenter phase III clinical study with two arms that aims to evaluate the effects of hyperthermic intraperitoneal chemotherapy with oxaliplatin on patients with gastric cancer involving the serosa and /or lymph node involvement and /or with positive cytology at peritoneal washing , treated with perioperative systemic chemotherapy and D1-D2 curative gastrectomy . Peroperatively , at the end of curative surgery , patients will be r and omized after preoperatively written consent has been given for participation . Primary endpoint will be overall survival from the date of surgery to the date of death or to the end of follow-up ( 5 years ) . Secondary endpoint will be 3- and 5-year recurrence-free survival , site of recurrence , morbidity , and quality of life . An ancillary study will compare the incidence of positive peritoneal cytology pre- and post-gastrectomy in two arms of the study , and assess its impact on 5-year survival . The number of patients to be r and omized was calculated to be 306.Trial registration EudraCT number : 2012 - 005748 - 12 , Clinical Trials.gov identifier : NCT01882933",
"Summary Background Peri-operative chemotherapy and surgery is a st and ard of care for patients with resectable oesophagogastric adenocarcinoma . Bevacizumab , a monoclonal antibody against VEGF , improves the proportion of patients responding to treatment in advanced gastric cancer . We aim ed to assess the safety and efficacy of adding bevacizumab to peri-operative chemotherapy in patients with resectable gastric , oesophagogastric junction , or lower oesophageal adenocarcinoma . Methods In this multicentre , r and omised , open-label phase 2–3 trial , we recruited patients aged 18 years and older with histologically proven , resectable oesophagogastric adenocarcinoma from 87 UK hospitals and cancer centres . We r and omly assigned patients 1:1 to receive peri-operative epirubicin , cisplatin , and capecitabine chemotherapy or chemotherapy plus bevacizumab , in addition to surgery . Patients in the control group ( chemotherapy alone ) received three pre-operative and three post-operative cycles of epirubicin , cisplatin , and capecitabine chemotherapy : 50 mg/m2 epirubicin and 60 mg/m2 cisplatin on day 1 and 1250 mg/m2 oral capecitabine on days 1–21 . Patients in the investigational group received the same treatment as the control group plus 7·5 mg/kg intravenous bevacizumab on day 1 of every cycle of chemotherapy and for six further doses once every 21 days following chemotherapy , as maintenance treatment . R and omisation was done by means of a telephone call to the Medical Research Council Clinical Trials Unit , where staff used a computer programme that implemented a minimisation algorithm with a r and om element to establish the allocation for the patient at the point of r and omisation . Patients were stratified by chemotherapy centre , site of tumour , and tumour stage . The primary outcome for the phase 3 stage of the trial was overall survival ( defined as the time from r and omisation until death from any cause ) , analysed in the intention-to-treat population . Here , we report the primary analysis results of the trial ; all patients have completed treatment and the required number of primary outcome events has been reached . This study is registered as an International St and ard R and omised Controlled Trial , number IS RCT N 46020948 , and with Clinical Trials.gov , number NCT00450203 . Findings Between Oct 31 , 2007 , and March 25 , 2014 , 1063 patients were enrolled and r and omly assigned to receive chemotherapy alone ( n=533 ) or chemotherapy plus bevacizumab ( n=530 ) . At the time of analysis , 508 deaths were recorded ( 248 in the chemotherapy alone group and 260 in the chemotherapy plus bevacizumab group ) . 3-year overall survival was 50·3 % ( 95 % CI 45·5–54·9 ) in the chemotherapy alone group and 48·1 % ( 43·2–52·7 ) in the chemotherapy plus bevacizumab group ( hazard ratio [ HR ] 1·08 , 95 % CI 0·91–1·29 ; p=0·36 ) . Apart from neutropenia no other toxic effects were reported at grade 3 or worse severity in more than 10 % of patients in either group . Wound healing complications were more prevalent in the bevacizumab group , occurring in 53 ( 12 % ) patients in this group compared with 33 ( 7 % ) patients in the chemotherapy alone group . In patients who underwent oesophagogastrectomy , post-operative anastomotic leak rates were higher in the chemotherapy plus bevacizumab group ( 23 [ 10 % ] of 233 in the chemotherapy alone group vs 52 [ 24 % ] of 220 in the chemotherapy plus bevacizumab group ) ; therefore , recruitment of patients with lower oesophageal or junctional tumours planned for an oesophagogastric resection was stopped towards the end of the trial . Serious adverse events for all patients included anastomotic leaks ( 30 events in chemotherapy alone group vs 69 in the chemotherapy plus bevacizumab group ) , and infections with normal neutrophil count ( 42 events vs 53 ) . Interpretation The results of this trial do not provide any evidence for the use of bevacizumab in combination with peri-operative epiribicin , cisplatin , and capecitabine chemotherapy for patients with resectable gastric , oesophagogastric junction , or lower oesophageal adenocarcinoma . Bevacizumab might also be associated with impaired wound healing . Funding Cancer Research UK , MRC Clinical Trials Unit at University College London , and F Hoffmann-La Roche Limited",
"BACKGROUND D2 gastrectomy is recommended in US and European guidelines , and is preferred in east Asia , for patients with resectable gastric cancer . Adjuvant chemotherapy improves patient outcomes after surgery , but the benefits after a D2 resection have not been extensively investigated in large-scale trials . We investigated the effect on disease-free survival of adjuvant chemotherapy with capecitabine plus oxaliplatin after D2 gastrectomy compared with D2 gastrectomy only in patients with stage II-IIIB gastric cancer . METHODS The capecitabine and oxaliplatin adjuvant study in stomach cancer ( CLASSIC ) study was an open-label , parallel-group , phase 3 , r and omised controlled trial undertaken in 37 centres in South Korea , China , and Taiwan . Patients with stage II-IIIB gastric cancer who had had curative D2 gastrectomy were r and omly assigned to receive adjuvant chemotherapy of eight 3-week cycles of oral capecitabine ( 1000 mg/m(2 ) twice daily on days 1 to 14 of each cycle ) plus intravenous oxaliplatin ( 130 mg/m(2 ) on day 1 of each cycle ) for 6 months or surgery only . Block r and omisation was done by a central interactive computerised system , stratified by country and disease stage . Patients , and investigators giving interventions , assessing outcomes , and analysing data were not masked . The primary endpoint was 3 year disease-free survival , analysed by intention to treat . This study reports a prespecified interim efficacy analysis , after which the trial was stopped after a recommendation by the data monitoring committee . The trial is registered at Clinical Trials.gov ( NCT00411229 ) . FINDINGS 1035 patients were r and omised ( 520 to receive chemotherapy and surgery , 515 surgery only ) . Median follow-up was 34·2 months ( 25·4 - 41·7 ) in the chemotherapy and surgery group and 34·3 months ( 25·6 - 41·9 ) in the surgery only group . 3 year disease-free survival was 74 % ( 95 % CI 69 - 79 ) in the chemotherapy and surgery group and 59 % ( 53 - 64 ) in the surgery only group ( hazard ratio 0·56 , 95 % CI 0·44 - 0·72 ; p were reported in 279 of 496 patients ( 56 % ) in the chemotherapy and surgery group and in 30 of 478 patients ( 6 % ) in the surgery only group . The most common adverse events in the intervention group were nausea ( n=326 ) , neutropenia ( n=300 ) , and decreased appetite ( n=294 ) . INTERPRETATION Adjuvant capecitabine plus oxaliplatin treatment after curative D2 gastrectomy should be considered as a treatment option for patients with operable gastric cancer . FUNDING F Hoffmann-La Roche and Sanofi-Aventis",
"Background The prognosis for stage 3 gastric cancer is not satisfactory , even with S-1 adjuvant chemotherapy . A r and omized phase II trial was conducted to compare two and four courses of neoadjuvant S-1/cisplatin ( SC ) and paclitaxel/cisplatin ( PC ) using a two-by-two factorial design for locally advanced gastric cancer . The primary endpoint was overall survival . We clarified the impact of these regimens on the secondary endpoints , including the clinical and pathological responses , chemotherapy-related toxicities , and surgical results . Methods Patients received S-1 ( 80 mg/m2 for 21 days with 1 week ’s rest)/cisplatin ( 60 mg/m2 at day 8) or paclitaxel/cisplatin ( 80 and 25 mg/m2 , respectively , on days 1 , 8 , and 15 with 1 week ’s rest ) as neoadjuvant chemotherapy . Results Eighty-three patients were assigned to arm A ( two courses of SC , n = 21 ) , arm B ( four courses of SC , n = 20 ) , arm C ( two courses of PC , n = 21 ) , and arm D ( four courses of PC , n = 21 ) . Pathological response rate was 43 % in arm A , 40 % in arm B , 29 % in arm C , and 38 % in arm D. Pathological complete response was only observed in arms B ( 10 % ) and D ( 10 % ) . Most bone marrow toxicities , nausea , vomiting , alopecia , and fatigue were slightly higher but acceptable in arms B and D. Grade 3/4 surgical morbidities were not commonly observed in all four arms . Conclusions Pathological complete response could be induced by four courses of neoadjuvant chemotherapy without a marked increase of toxicities , regardless of a SC or PC regimen",
"BACKGROUND Trastuzumab , a monoclonal antibody against human epidermal growth factor receptor 2 ( HER2 ; also known as ERBB2 ) , was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer . METHODS ToGA ( Trastuzumab for Gastric Cancer ) was an open-label , international , phase 3 , r and omised controlled trial undertaken in 122 centres in 24 countries . Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumours showed overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation . Participants were r and omly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous trastuzumab . Allocation was by block r and omisation stratified by Eastern Cooperative Oncology Group performance status , chemotherapy regimen , extent of disease , primary cancer site , and measurability of disease , implemented with a central interactive voice recognition system . The primary endpoint was overall survival in all r and omised patients who received study medication at least once . This trial is registered with Clinical Trials.gov , number NCT01041404 . FINDINGS 594 patients were r and omly assigned to study treatment ( trastuzumab plus chemotherapy , n=298 ; chemotherapy alone , n=296 ) , of whom 584 were included in the primary analysis ( n=294 ; n=290 ) . Median follow-up was 18.6 months ( IQR 11 - 25 ) in the trastuzumab plus chemotherapy group and 17.1 months ( 9 - 25 ) in the chemotherapy alone group . Median overall survival was 13.8 months ( 95 % CI 12 - 16 ) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months ( 10 - 13 ) in those assigned to chemotherapy alone ( hazard ratio 0.74 ; 95 % CI 0.60 - 0.91 ; p=0.0046 ) . The most common adverse events in both groups were nausea ( trastuzumab plus chemotherapy , 197 [ 67 % ] vs chemotherapy alone , 184 [ 63 % ] ) , vomiting ( 147 [ 50 % ] vs 134 [ 46 % ] ) , and neutropenia ( 157 [ 53 % ] vs 165 [ 57 % ] ) . Rates of overall grade 3 or 4 adverse events ( 201 [ 68 % ] vs 198 [ 68 % ] ) and cardiac adverse events ( 17 [ 6 % ] vs 18 [ 6 % ] ) did not differ between groups . INTERPRETATION Trastuzumab in combination with chemotherapy can be considered as a new st and ard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer . FUNDING F Hoffmann-La Roche",
"Background Postoperative chemoradiation and perioperative chemotherapy using epirubicin/cisplatin/5-fluorouracil ( ECF ) represent two st and ards of care for resectable gastric cancer . In the TOPGEAR ( Trial Of Preoperative therapy for Gastric and Esophagogastric junction AdenocaRcinoma ) trial , we hypothesized that adding preoperative chemoradiation to perioperative ECF will improve survival ; however , the safety and feasibility of preoperative chemoradiation have yet to be determined . Methods TOPGEAR is an international phase III trial in which patients with adenocarcinoma of the stomach were r and omized to perioperative ECF alone or with preoperative chemoradiation . The ECF-alone group received three preoperative cycles of ECF , while the chemoradiation group received two cycles of preoperative ECF followed by chemoradiation . Both groups received three postoperative cycles of ECF . A planned interim analysis of the first 120 patients was conducted , and was review ed by the Independent Data Safety Monitoring Committee to assess treatment compliance , toxicity/safety , and response rates . Results The proportion of patients who received all cycles of preoperative chemotherapy was 93 % ( ECF group ) and 98 % ( chemoradiation group ) , while 65 and 53 % , respectively , received all cycles of postoperative chemotherapy . Overall , 92 % of patients allocated to preoperative chemoradiation received this treatment . The proportion of patients proceeding to surgery was 90 % ( ECF group ) and 85 % ( chemoradiation group ) . Grade 3 or higher surgical complications occurred in 22 % of patients in both groups . Furthermore , grade 3 or higher gastrointestinal toxicity occurred in 32 % ( ECF group ) and 30 % ( chemoradiation group ) of patients , while hematologic toxicity occurred in 50 and 52 % of patients . Conclusions These results demonstrate that preoperative chemoradiation can be safely delivered to the vast majority of patients without a significant increase in treatment toxicity or surgical morbidity",
"Esophageal and gastric cancer is associated with a poor prognosis since many patients develop recurrent disease . Treatment requires specific expertise and a structured multidisciplinary approach . In the Netherl and s , this type of expertise is mainly found at the University Medical Centers ( UMCs ) and a few specialized nonacademic centers . Aim of this study is to implement a national infrastructure for research to gain more insight in the etiology and prognosis of esophageal and gastric cancer and to evaluate and improve the response on ( neoadjuvant ) treatment . Clinical data are collected in a prospect i ve data base , which is linked to the patients ' bio material . The collection and storage of bio material is performed according to st and ard operating procedures in all participating UMCs as established within the Parelsnoer Institute . The collected bio material consists of tumor biopsies , blood sample s , sample s of malignant and healthy tissue of the resected specimen and biopsies of recurrence . The collected material is stored in the local biobanks and is encoded to respect the privacy of the donors . After approval of the study was obtained from the Institutional Review Board , the first patient was included in October 2014 . The target aim is to include 300 patients annually . In conclusion , the eight UMCs of the Netherl and s collaborated to establish a nationwide data base of clinical information and bio material of patients with esophageal and gastric cancer . Due to the national coverage , a high number of patients are expected to be included . This will provide opportunity for future studies to gain more insight in the etiology , treatment and prognosis of esophageal and gastric cancer",
"BACKGROUND The role of bursectomy , in which the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon are dissected , has long been controversial for preventing peritoneal metastasis . We investigated the survival benefit of bursectomy in patients with resectable gastric cancer . METHODS This phase 3 , open-label , r and omised controlled trial was done at 57 hospitals in Japan . Patients aged 20 - 80 years who had cT3(SS)-cT4a(SE ) histologically proven gastric adenocarcinoma with an Eastern Cooperative Oncology Group performance status of 0 or 1 and body-mass index less than 30 kg/m2 and who did not have distant metastasis or bulky lymph nodes were r and omly assigned ( 1:1 ) during surgery to receive omentectomy alone ( non-bursectomy ) or bursectomy . R and omisation was done by telephone or website to the Japan Clinical Oncology Group Data Center and used a minimisation method with a r and om component to adjust for institution , cT status ( T3 vs T4a ) , and type of gastrectomy ( distal vs total ) . Both groups had total or distal gastrectomy with D2 lymphadenectomy . The primary endpoint was overall survival , analysed in the intention-to-treat population . The study is registered with UMIN-CTR , number UMIN000003688 . FINDINGS Between June 1 , 2010 , and March 30 , 2015 , 1503 patients were enrolled based on preoperative inclusion and exclusion criteria . Intraoperative inclusion and exclusion criteria were met in 1204 patients , of which 602 were allocated to the non-bursectomy group and 602 were allocated to the bursectomy group . At the planned second interim analysis on Sept 17 , 2016 , the JCOG Data and Safety Monitoring Committee independently review ed the results and recommended their early publication on the basis of futility because overall survival was lower in the bursectomy group than the non-bursectomy group , and because the predictive probability of overall survival being significantly higher in bursectomy than non-bursectomy patients at the final analysis was only 12·7 % . 5-year overall survival was 76·7 % ( 95 % CI 72·0 - 80·6 ) in the non-bursectomy group and 76·9 % ( 72·6 - 80·7 ) in the bursectomy group ( hazard ratio 1·05 , 95 % CI 0·81 - 1·37 , one-sided p=0·65 ) . 64 ( 11 % ) of 601 in the non-bursectomy group and 77 ( 13 % ) of 600 patients in the bursectomy group had grade 3 - 4 operative morbidity . Pancreatic fistula was significantly more common in the bursectomy group than in the non-bursectomy group ( 29 [ 5 % ] vs 15 [ 2 % ] ; p=0·032 ) . Six deaths occurred either in hospital or within 1 month of surgery : five in the non-bursectomy group and one in the bursectomy group . INTERPRETATION Bursectomy did not provide a survival advantage over non-bursectomy . D2 dissection with omentectomy alone should be done as a st and ard surgery for resectable cT3-T4a gastric cancer . FUNDING Japan Agency for Medical Research and Development , the Ministry of Health , Labour and Welfare of Japan , and the National Cancer Centre Research and Development Fund",
"Background Along with the marked increase in early gastric cancer ( EGC ) in the Eastern countries , there has been an effort to adopt the sentinel node concept in EGC to preserve gastric function and reduce the occurrence of postoperative complications . Based on promising results from a previous quality control study , this prospect i ve multicenter r and omized controlled phase III clinical trial aims to eluci date the oncologic safety of laparoscopic stomach-preserving surgery with sentinel basin dissection ( SBD ) compared to a st and ard laparoscopic gastrectomy . Methods / Design This trial is an investigator-initiated , open-label , multicenter r and omized controlled phase III trial with a non-inferiority design . Patients diagnosed with a single lesion of clinical stage T1N0M0 gastric adenocarcinoma , with a diameter of 3 cm or less are eligible for the present study . A total of 580 patients ( 290 per group ) will be r and omized to either laparoscopic stomach-preserving surgery with SBD or st and ard surgery . The primary end-point is 3-year disease-free survival ( DFS ) and the secondary endpoints include postoperative morbidity and mortality , quality of life , 5-year DFS , and overall survival . Qualified investigators who completed the prior quality control study are exclusively allowed to participate in this phase III clinical trial . Discussion The proposed trial is expected to verify whether laparoscopic stomach-preserving surgery with SBD achieves similar oncologic outcomes and improved quality of life compared to a st and ard gastrectomy in EGC patients .Trial registration This study was registered at the NIH Clinical Trial.gov data base ( NCT01804998 ) on March 4th , 2013",
"Purpose This multicenter , r and omized controlled study evaluates the safety of early oral feeding following gastrectomy , and its effect on the length of postoperative hospital stay . Methods The subjects of this study were patients who underwent distal gastrectomy ( DG ) or total gastrectomy ( TG ) for gastric cancer between January 2014 and December 2015 . Patients were r and omly assigned to the early oral feeding group ( intervention group ) or the conventional postoperative management group ( control group ) for each procedure . We evaluated the length of postoperative hospital stay and the incidence of postoperative complications in each group . Results No significant differences in length of postoperative stay were found between the intervention and control groups of the patients who underwent DG . The incidence of postoperative complications was significantly greater in the DG intervention group . In contrast , the length of postoperative stay was significantly shorter in the TG intervention group , although the TG group did not attain the established target sample size . Conclusion Early oral feeding did not shorten the postoperative hospital stay after DG . The higher incidence of postoperative complications precluded the unselected adoption of early oral feeding for DG patients . Further confirmative studies are required to definitively establish the potential benefits of early oral feeding for TG patients ",
"PURPOSE Previous studies have demonstrated a beneficial effect of intraperitoneally applied mitomycin bound to activated carbon particles ( M-CH ) in preventing intraabdominal recurrence following curative surgery for gastric cancer . The Austrian Working Group for Stomach Cancer , a subgroup of the Austrian Working Group for Surgical Oncology , initiated a multicentric phase III trial to evaluate the safety and efficacy of this treatment regimen . PATIENTS AND METHODS A total of 91 patients with a radically resected gastric cancer infiltrating the serosal surface were r and omly assigned to receive either 50 mg mitomycin bound to a solution of 375 mg carbo adsorbens intraperitoneally before closure of the abdominal wound ( n = 46 ) or served as a surgical control group ( n = 45 ) . Postoperative complications and recurrence-free and overall survival were evaluated to analyze the risks and benefits of this treatment . RESULTS After a median observation period of 597 days ( range , 72 to 1,096 ) , a significantly higher postoperative complication rate was observed in the M-CH group ( 35 % ) compared with the control group ( 16 % ) ( P mortality rate was also significantly elevated in the M-CH group ( 11 % v 2 % in the control group ) . Since analysis of overall and recurrence-free survival failed to show any beneficial effect of M-CH therapy , the protocol committee decided to stop further recruitment of patients onto this study . CONCLUSION Adjuvant intraperitoneal therapy of gastric cancer by mitomycin bound to activated carbon particles is associated with an increased rate of postoperative complications . However , no benefit for prognosis following radical resection of locally advanced tumors was observed in this multicenter phase III trial",
"Background Most studies showing a volume outcome effect in resection surgery for oesophago-gastric cancer were conducted before the central isation of clinical services . This study evaluated the relation between hospital- and surgeon volume and different risk-adjusted outcomes after oesophago-gastric ( OG ) cancer surgery in Engl and between 2011 and 2013 . Methods In data from the National Oesophago-Gastric Cancer Audit from the UK , multivariable r and om-effects logistic regression models were used to quantify the effect of surgeon and hospital volume on three outcomes : 30-day and 90-day mortality and anastomotic leakage . The models included patient risk factors to adjust for differences in case-mix among hospitals and surgeons . The between-cluster heterogeneity was estimated with the median odds ratio ( MOR ) . Results The study included patients treated at 42 hospitals and 329 surgeons . The median ( interquartile range ) of the annual hospital and surgeon volumes were 110 patients ( 82 to 137 ) and 13 patients ( 8 to 19 ) , respectively . The overall rates for 30-day and 90-day mortality were 2.3 % and 4.4 % respectively , and the anastomotic leakage was 6.3 % . Higher hospital volume was associated with lower 30-day mortality ( OR : 0.94 ; 95 % CI : 0.91–0.98 ) and lower anastomotic leakage rates ( OR : 0.96 ; 95 % CI : 0.93–0.98 ) but not 90-day mortality . Higher surgeon volume was only associated with lower anastomotic leakage rates ( OR : 0.81 ; 95 % CI : 0.72–0.92 ) . Hospital volume explained a part of the between-hospital variation in 30-day mortality whereas surgeon volume explained part of the between-hospital variation in anastomotic leakage . Conclusions In the setting of central ized O-G cancer surgery in Engl and , we could still observe an effect of volume on short-term outcomes . However , the effect is inconsistent , depending on the type of outcome measure under consideration , and much smaller than in previous studies . Efforts to central ise O-G cancer services further should carefully address the effects of both hospital and surgeon volume on the range of outcome measures that are relevant to patients",
"PURPOSE Surgical resection of gastric cancer has produced suboptimal survival despite multiple r and omized trials that used postoperative chemotherapy or more aggressive surgical procedures . We performed a r and omized phase III trial of postoperative radiochemotherapy in those at moderate risk of locoregional failure ( LRF ) following surgery . We originally reported results with 4-year median follow-up . This up date , with a more than 10-year median follow-up , presents data on failure patterns and second malignancies and explores selected subset analyses . PATIENTS AND METHODS In all , 559 patients with primaries ≥ T3 and /or node-positive gastric cancer were r and omly assigned to observation versus radiochemotherapy after R0 resection . Fluorouracil and leucovorin were administered before , during , and after radiotherapy . Radiotherapy was given to all LRF sites to a dose of 45 Gy . RESULTS Overall survival ( OS ) and relapse-free survival ( RFS ) data demonstrate continued strong benefit from postoperative radiochemotherapy . The hazard ratio ( HR ) for OS is 1.32 ( 95 % CI , 1.10 to 1.60 ; P = .0046 ) . The HR for RFS is 1.51 ( 95 % CI , 1.25 to 1.83 ; P Adjuvant radiochemotherapy produced substantial reduction in both overall relapse and locoregional relapse . Second malignancies were observed in 21 patients with radiotherapy versus eight with observation ( P = .21 ) . Subset analyses show robust treatment benefit in most subsets , with the exception of patients with diffuse histology who exhibited minimal nonsignificant treatment effect . CONCLUSION Intergroup 0116 ( INT-0116 ) demonstrates strong persistent benefit from adjuvant radiochemotherapy . Toxicities , including second malignancies , appear acceptable , given the magnitude of RFS and OS improvement . LRF reduction may account for the majority of overall relapse reduction . Adjuvant radiochemotherapy remains a rational st and ard therapy for curatively resected gastric cancer with primaries T3 or greater and /or positive nodes",
"Objective To determine the relative safety and efficacy of 3D laparoscopic gastrectomy and 2D laparoscopic surgery in patients with gastric cancer . Background There is still a lack of r and omized controlled trials regarding the safety and efficacy of 3D versus 2D laparoscopic surgery for gastric cancer . Methods A large‐scale , phase 3 , prospect i ve , r and omized controlled trial was conducted . ( Clinical Trials.gov number NCT02327481 ) . Results A total of 438 patients were r and omized ( 3D group : 219 cases ; 2D group : 219 cases ) between January 1 , 2015 , and April 1 , 2016 ; 19 patients were excluded . Finally , data from 419 patients were analyzed ( 3D group : 211 cases ; 2D group : 208 cases ) . There were no differences between the 2 groups regarding the operation time ( 3D versus 2D , 176 ± 35 min vs. 174 ± 33 min , P = .562 ) . The intraoperative blood loss in the 3D group was somewhat less than in the 2D group ( 61 ± 83 mL vs. 82 ± 119 mL , P = .045 ) . Further analysis suggested that the use of 3D laparoscopic surgery was a protective factor against excessive blood loss ( ≥200 mL ) . Conclusion 3D laparoscopic gastrectomy did not shorten the operation time compared with 2D laparoscopic gastrectomy , but provided the benefit of less intraoperative blood loss and a lesser occurrence of excessive bleeding than the conventional 2D laparoscopic gastrectomy ; the clinical value of the difference is limited",
"BACKGROUND Surgical resection of adenocarcinoma of the stomach is curative in less than 40 percent of cases . We investigated the effect of surgery plus postoperative ( adjuvant ) chemoradiotherapy on the survival of patients with resectable adenocarcinoma of the stomach or gastroesophageal junction . METHODS A total of 556 patients with resected adenocarcinoma of the stomach or gastroesophageal junction were r and omly assigned to surgery plus postoperative chemoradiotherapy or surgery alone . The adjuvant treatment consisted of 425 mg of fluorouracil per square meter of body-surface area per day , plus 20 mg of leucovorin per square meter per day , for five days , followed by 4500 cGy of radiation at 180 cGy per day , given five days per week for five weeks , with modified doses of fluorouracil and leucovorin on the first four and the last three days of radiotherapy . One month after the completion of radiotherapy , two five-day cycles of fluorouracil ( 425 mg per square meter per day ) plus leucovorin ( 20 mg per square meter per day ) were given one month apart . RESULTS The median overall survival in the surgery-only group was 27 months , as compared with 36 months in the chemoradiotherapy group ; the hazard ratio for death was 1.35 ( 95 percent confidence interval , 1.09 to 1.66 ; P=0.005 ) . The hazard ratio for relapse was 1.52 ( 95 percent confidence interval , 1.23 to 1.86 ; P died from toxic effects of the chemoradiotherapy ; grade 3 toxic effects occurred in 41 percent of the patients in the chemoradiotherapy group , and grade 4 toxic effects occurred in 32 percent . CONCLUSIONS Postoperative chemoradiotherapy should be considered for all patients at high risk for recurrence of adenocarcinoma of the stomach or gastroesophageal junction who have undergone curative resection",
"Background The effects of preoperative malnutrition and preoperative correction of hypoalbuminemia ( PCH ) on the short- and long-term outcomes in patients with gastric cancer are unclear . Objective This study aim ed to examine the effect of preoperative nutritional status on short- and long-term outcomes in patients who underwent radical gastrectomy , and also explored the role of PCH in malnourished patients with gastric cancer . Methods We prospect ively review ed data from patients with gastric cancer who were treated in our department between January 2009 and December 2014 . The effect of preoperative nutritional status on short- and long-term outcomes in patients who underwent radical gastrectomy was investigated , and we explored whether PCH could improve the short- and long-term outcomes of these patients . Results A total of 1976 patients were analyzed , including 412 patients in the malnourished group and 1564 in the well-nourished group . The overall incidence of complications in the malnourished group was significantly higher than the well-nourished group ( 21.4 vs. 15.5 % , p = 0.005 ) . Except for incision infection ( 3.2 vs. 1.6 % , p = 0.041 ) , there were no significant differences for other complications . In the malnourished group , 98 cases of preoperative hypoproteinemia were corrected ( PCH group ) , whereas 314 cases were not ( NPCH group ) . The incidence of incision infection in the PCH group was significantly lower than in the NPCH group ( 0 vs. 4.1 % , p = 0.041 ) . The median follow-up time was 39 months ( 1.0–88.0 months ) , and the 3-year overall survival ( OS ; 59.1 vs. 75 % , p 0.001 ) and disease-free survival ( DFS ; 54.8 vs. 72.5 % , p malnutrition was an independent prognostic factor for 3-year OS ( hazard ratio [ HR ] 1.211 , 95 % confidence interval [ CI ] 1.01–1.452 , p = 0.039 ) and DFS ( HR 1.168 , 95 % CI 1.013–1.398 , p = 0.043 ) . For the malnourished group with stage I gastric cancer , the PCH and NPCH groups showed no significant differences in 3-year OS ( 90.0 vs. 89.0 % , p = 0.227 ) or DFS ( 90.0 vs. 87.3 % , p = 0.363 ) ; however , for the malnourished group with stages II – III gastric cancer , the 3-year OS ( 69.9 vs. 47.6 % , p = 0.013 ) and DFS ( 55.4 vs. 43.6 % , p = 0.046 ) rates were significantly higher in the PCH group than in the NPCH group . Conclusions The incidence of incision infection was significantly higher in patients with malnutrition than in well-nourished patients . The 3-year OS and DFS rates were significantly lower in malnourished patients than in well-nourished patients . PCH may both reduce the incidence of incisional infection in patients with malnutrition and improve 3-year OS and DFS rates for malnourished patients with stages II – III gastric cancer ; however , to confirm our findings , further studies are warranted",
"A 3‐year prospect i ve study of the learning curve for D2 gastrectomy was carried out by one surgeon beginning to perform the operation independently after intensive specialist training . Some 38 patients were treated ; there were four postoperative deaths and 22 patients had complications . Postoperative morbidity decreased significantly with time ( rs= ‐0·38 , P = 0·02 , 95 per cent confidence interval ‐ 0·62 to ‐ 0·07 ) . The physiological component of POSSUM ( Physiological and Operative Severity Score for the enumeration of Mortality and morbidity ) was significantly lower in the third year ( median value 15 , 16 and 14 for years 1 , 2 and 3 , n = 31 , χ2 = 7·5 , 2 d.f . , P = 0·02 , Kruskal‐Wallis test ) , but the operative POSSUM scores and the number of lymph nodes found were not decreased ( median operative POSSUM score 19 , 18 and 21 , n = 31 , χ2 = 0·2 , 2 d.f . , P = 0·91 , Kruskal‐Wallis test ) . The results suggest a learning curve lasting about 18–24 months or 15 to 25 procedures before a plateau is reached . Improved results were associated with changes in case selection and operative tactics but not with reduced extent of lymphadenectomy . D2 gastrectomy should be restricted to specialist centres where adequate training and supervision can be provided during the learning curve",
"Deep learning using convolutional neural networks is an actively emerging field in histological image analysis . This study explores deep learning methods for computer-aided classification in H&E stained histopathological whole slide images of gastric carcinoma . An introductory convolutional neural network architecture is proposed for two computerized applications , namely , cancer classification based on immunohistochemical response and necrosis detection based on the existence of tumor necrosis in the tissue . Classification performance of the developed deep learning approach is quantitatively compared with traditional image analysis methods in digital histopathology requiring prior computation of h and crafted features , such as statistical measures using gray level co-occurrence matrix , Gabor filter-bank responses , LBP histograms , gray histograms , HSV histograms and RGB histograms , followed by r and om forest machine learning . Additionally , the widely known AlexNet deep convolutional framework is comparatively analyzed for the corresponding classification problems . The proposed convolutional neural network architecture reports favorable results , with an overall classification accuracy of 0.6990 for cancer classification and 0.8144 for necrosis detection ",
"Purpose Adjuvant chemotherapy trial of TS-1 for gastric cancer study demonstrated that postoperative S-1 chemotherapy for 1 year improved overall survival of locally advanced gastric cancer ( LAGC ) patients . The goals of this study were to evaluate the feasibility and efficacy of neoadjuvant docetaxel , oxaliplatin , and S-1 ( DOS ) chemotherapy followed by surgery and adjuvant S-1 chemotherapy . Methods In this single-center , open-label , phase II study , patients with potentially resectable adenocarcinoma of the stomach or gastroesophageal junction were eligible . For neoadjuvant chemotherapy , docetaxel 50 mg/m2 on day ( D ) 1 , oxaliplatin 100 mg/m2 on D1 , and S-1 40 mg/m2 bid orally on D1–14 were administrated every 3 weeks for three cycles . After DOS chemotherapy , gastrectomy was performed , and then , adjuvant S-1 40 mg/m2 bid was given on D1–28 every 6 weeks for 1 year . The primary endpoints were the proportion of patients who did not experience grade 3 or 4 toxicities ( except grade 3 neutropenia ) and R0 resection rates . Results A total of 41 patients were enrolled . All patients completed three planned cycles of neoadjuvant chemotherapy without disease progression . Eighteen patients ( 43.9 % ) did not experience any grade 3–4 toxicity ( except grade 3 neutropenia ) during the neoadjuvant chemotherapy . All patients underwent surgery , and R0 resection was achieved in 40 patients ( 97.6 % ) . Conclusion Neoadjuvant DOS chemotherapy could be performed safely with a high R0 resection rate in LAGC patients . A phase III trial is currently underway",
"BACKGROUND / AIMS Although the most frequent cause of death after curative resection of advanced gastric cancer is peritoneal recurrence , there was no effective therapy for the prevention of peritoneal recurrence . This r and omized trial sought to determine whether intraoperative chemohyperthermic peritoneal perfusion could eliminate microscopic residual disease and thereby improve survival of patients with advanced gastric cancer . METHODOLOGY One-hundred and thirty-nine patients with T2 - 4 gastric cancer underwent curative gastrectomy with extended lymphadenectomy . These patients were r and omly allocated into the following three groups . Patients in the CHPP group received surgery + chemohyperthermic peritoneal perfusion , and those in the CNPP group underwent surgery + chemonormothermic peritoneal perfusion . The third group was surgery alone group . In the CHPP and CNPP groups , peritoneal cavity was perfused with 6 - 8 liters of heated saline at , respectively , 42 - 43 degrees C and 37 degrees C with 30 mg of mitomycin C and 300 mg of cisplatin by a extracorporeal circulation machine . RESULTS Major operative complication occurred in 19 % ( 9/48 ) , 14 % ( 6/44 ) and 19 % ( 9/47 ) of the CHPP , CNPP and surgery alone group , respectively . Complication which uniquely developed after chemohyperthermic peritoneal perfusion was bowel perforation . Mortality rates of each group were 4 % ( 2/48 ) , 0 % ( 0/44 ) and 4 % ( 2/47 ) in the CHPP , CNPP and surgery alone group , respectively . Overall 5-year survival rates of CHPP , CNPP and surgery alone groups were 61 % , 43 % and 42 % , respectively . In a subset analysis , patients with gastric cancer having serosal invasion or lymph node metastasis have shown a statistically significant improvement in survival when treated with chemohyperthermic peritoneal perfusion . However , chemonormothermic peritoneal perfusion had no survival benefit . By analyzing with Cox proportional hazard model , chemohyperthermic peritoneal perfusion emerged as an independent prognostic factor for good survival . Surgery alone had three-fold higher risk of death than chemohyperthermic peritoneal perfusion . CONCLUSIONS Chemohyperthermic peritoneal perfusion had an efficiency for the prophylaxis of recurrence after curative resection of advanced gastric cancer , and is indicated for patients with tumor infiltrating beyond serosal layer and node positive tumor",
"BACKGROUND AND OBJECTIVES The role of radiation therapy in resectable gastric cancer is question able . To study the value of concentrated preoperative radiotherapy , a r and omized clinical trial had been carried out . METHODS From 1974 to 1978 , 152 patients were r and omized and underwent exploratory laparotomy ; in 50 patients curative surgery was not possible , while 102 patients satisfied protocol requirements and entered in the trial . Patients in the experimental group were treated with preoperative radiotherapy ( 20 Gy/5 days ) and subtotal or total gastrectomy . Patients in the control group underwent surgery alone . RESULTS Study showed acceptable tolerance of radiotherapy regime with no increase of postoperative mortality and morbidity . There was no significant difference in survival between the two treatment groups ( chi 2 = 0.349 , df = 1 , P = 0.555 ) . Subset analysis also failed to demonstrate significant survival advantages of the combined treatment ; however , some positive trends were seen in patients with locally advanced gastric cancer . CONCLUSIONS Concentrated preoperative radiotherapy in the dose of 20 Gy is safe and feasible , but seems to be insufficient to improve survival in gastric cancer patients . However , the results are promising in selected subgroups of patients , which encourages future trials with adjuvant radiation therapy ",
"Purpose Identification of the infrapyloric artery ( IPA ) type is a key component of pylorus-preserving gastrectomy . As the indocyanine green ( ICG ) fluorescence technique is known to help visualize blood vessels and flow during reconstruction , we speculated that this emerging technique would be helpful in identifying the IPA type . Material s and Methods From August 2015 to February 2016 , 20 patients who underwent robotic or laparoscopic gastrectomy were prospect ively enrolled . After intravenous injection of approximately 3 mL of ICG ( 2.5 mg/mL ) , a near-infrared fluorescence apparatus was applied . The identified shape of the IPA was confirmed by examining the actual anatomy following infrapyloric dissection . Results The mean interval time between ICG injection and visualization of the artery was 22.2 seconds ( range , 14–30 seconds ) , and the mean duration of the arterial phase was 16.1 seconds ( range , 9–30 seconds ) . The overall positive predictive value ( PPV ) of ICG fluorescence in identifying the IPA type was 80 % ( 16/20 ) . The IPA type was incorrectly predicted in four patients , all of whom were obese with a body mass index ( BMI ) of more than 25 kg/m2 . Conclusions Our preliminary results indicate that intraoperative vascular imaging using the ICG fluorescence technique may be helpful for robotic or laparoscopic pylorus-preserving gastrectomy",
"Squamous cell carcinoma of the anus ( SCCA ) is a rare cancer but its incidence is increasing throughout the world , and is particularly high in the human immunodeficiency virus positive ( HIVþ ) population . A multidisciplinary approach is m and atory ( involving radiation therapists , medical oncologists , surgeons , radiologists and pathologists ) . SCCA usually spreads in a loco-regional manner within and outside the anal canal . Lymph node involvement at diagnosis is observed in 30%e40 % of cases while systemic spread is uncommon with distant extrapelvic metastases recorded in 5%e8 % at onset , and rates of metastatic progression after primary treatment between 10 and 20 % . SCCA is strongly associated with human papilloma virus ( HPV , types 16e18 ) infection . The primary aim of treatment is to achieve cure with loco-regional control and preservation of anal function , with the best possible quality of life . Treatment dramatically differs from adenocarcinomas of the lower rectum . Combinations of 5FU-based chemoradiation and other cytotoxic agents ( mitomycin C ) have been established as the st and ard of care , leading to complete tumour regression in 80%e90 % of patients with locoregional failures in the region of 15 % . There is an accepted role for surgical salvage . Assessment and treatment should be carried out in specialised centres treating a high number of patients as early as possible in the clinical diagnosis . To date , the limited evidence from only 6 r and omised trials [ 1,2,3,4,5,6,7 ] , the rarity of the cancer , and the different behaviour/natural history depending on the predominant site of origin , ( the anal margin , anal canal or above the dentate line ) provide scanty direction for any individual oncologist . Here we aim to provide guidelines which can assist medical , radiation and surgical oncologists in the practical management of this unusual cancer . 2014 Elsevier Ltd. All rights reserved",
"BACKGROUND Initial results of the ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study ( CROSS ) comparing neoadjuvant chemoradiotherapy plus surgery versus surgery alone in patients with squamous cell carcinoma and adenocarcinoma of the oesophagus or oesophagogastric junction showed a significant increase in 5-year overall survival in favour of the neoadjuvant chemoradiotherapy plus surgery group after a median of 45 months ' follow-up . In this Article , we report the long-term results after a minimum follow-up of 5 years . METHODS Patients with clinical ly resectable , locally advanced cancer of the oesophagus or oesophagogastric junction ( clinical stage T1N1M0 or T2 - 3N0 - 1M0 , according to the TNM cancer staging system , sixth edition ) were r and omly assigned in a 1:1 ratio with permuted blocks of four or six to receive either weekly administration of five cycles of neoadjuvant chemoradiotherapy ( intravenous carboplatin [ AUC 2 mg/mL per min ] and intravenous paclitaxel [ 50 mg/m(2 ) of body-surface area ] for 23 days ) with concurrent radiotherapy ( 41·4 Gy , given in 23 fractions of 1·8 Gy on 5 days per week ) followed by surgery , or surgery alone . The primary endpoint was overall survival , analysed by intention-to-treat . No adverse event data were collected beyond those noted in the initial report of the trial . This trial is registered with the Netherl and s Trial Register , number NTR487 , and has been completed . FINDINGS Between March 30 , 2004 , and Dec 2 , 2008 , 368 patients from eight participating centres ( five academic centres and three large non-academic teaching hospitals ) in the Netherl and s were enrolled into this study and r and omly assigned to the two treatment groups : 180 to surgery plus neoadjuvant chemoradiotherapy and 188 to surgery alone . Two patients in the neoadjuvant chemoradiotherapy group withdrew consent , so a total of 366 patients were analysed ( 178 in the neoadjuvant chemoradiotherapy plus surgery group and 188 in the surgery alone group ) . Of 171 patients who received any neoadjuvant chemoradiotherapy in this group , 162 ( 95 % ) were able to complete the entire neoadjuvant chemoradiotherapy regimen . After a median follow-up for surviving patients of 84·1 months ( range 61·1 - 116·8 , IQR 70·7 - 96·6 ) , median overall survival was 48·6 months ( 95 % CI 32·1 - 65·1 ) in the neoadjuvant chemoradiotherapy plus surgery group and 24·0 months ( 14·2 - 33·7 ) in the surgery alone group ( HR 0·68 [ 95 % CI 0·53 - 0·88 ] ; log-rank p=0·003 ) . Median overall survival for patients with squamous cell carcinomas was 81·6 months ( 95 % CI 47·2 - 116·0 ) in the neoadjuvant chemoradiotherapy plus surgery group and 21·1 months ( 15·4 - 26·7 ) in the surgery alone group ( HR 0·48 [ 95 % CI 0·28 - 0·83 ] ; log-rank p=0·008 ) ; for patients with adenocarcinomas , it was 43·2 months ( 24·9 - 61·4 ) in the neoadjuvant chemoradiotherapy plus surgery group and 27·1 months ( 13·0 - 41·2 ) in the surgery alone group ( HR 0·73 [ 95 % CI 0·55 - 0·98 ] ; log-rank p=0·038 ) . INTERPRETATION Long-term follow-up confirms the overall survival benefits for neoadjuvant chemoradiotherapy when added to surgery in patients with resectable oesophageal or oesophagogastric junctional cancer . This improvement is clinical ly relevant for both squamous cell carcinoma and adenocarcinoma subtypes . Therefore , neoadjuvant chemoradiotherapy according to the CROSS trial followed by surgical resection should be regarded as a st and ard of care for patients with resectable locally advanced oesophageal or oesophagogastric junctional cancer . FUNDING Dutch Cancer Foundation ( KWF Kankerbestrijding )",
"PURPOSE The long-term survival probability of patients who undergo surgery for stage 3 and 4 gastric cancer is poor , predominantly due to metastatic spread of the tumor . Depending on the type of tumor histology , the pathway of metastases is mainly peritoneal or hepatic dissemination . Interruption of this mechanism may be possible by intraperitoneal chemotherapy ( IPT ) . PATIENTS AND METHODS In a prospect i ve r and omized trial of 67 patients undergoing surgery for stage 3 and 4 gastric cancer , 33 patients underwent adjuvant postoperative IPT with cisplatin , while 34 control subjects remained untreated . RESULTS Patients in the treatment group received a median of four IPT perfusions . Apart from frequent nausea , no adverse reactions or complications were noted . The median disease-free survival duration s were 12.7 months and 9.7 months in treated patients and controls , respectively ( P = .8 ) . After a median follow-up duration of 72 months , 54 patients ( 80 % ) had died of primary disease or related complications . The median survival duration for IPT patients was 17.3 months as compared with 16.0 months for controls ( P = .6 ) . Autopsies were performed on 12 ( 18 % ) of 54 patients who died , and showed tumor spread to the peritoneal cavity and /or to the liver , irrespective of the application of IPT . CONCLUSION IPT with cisplatin monotherapy does not improve survival probability after surgery for stage 3 and 4 gastric cancer . The reasons for ineffectiveness of IPT may be the choice of an unsuitable chemotherapeutic agent , an inefficient modus of application , or a lack of sufficient drug penetration into the serosa or peritoneal metastasis",
"The majority of advanced gastric carcinoma patients with serosal invasion die of peritoneal recurrence , even when a curative gastrectomy is performed , because peritoneal recurrence occurs due to intraperitoneal free tumor cells that detach from the serosal‐invaded focus . In an attempt to prevent peritoneal recurrence , intraperitoneal hyperthermic chemoperfusion ( IHCP ) treatment was combined with aggressive surgery",
"BACKGROUND A regimen of epirubicin , cisplatin , and infused fluorouracil ( ECF ) improves survival among patients with incurable locally advanced or metastatic gastric adenocarcinoma . We assessed whether the addition of a perioperative regimen of ECF to surgery improves outcomes among patients with potentially curable gastric cancer . METHODS We r and omly assigned patients with resectable adenocarcinoma of the stomach , esophagogastric junction , or lower esophagus to either perioperative chemotherapy and surgery ( 250 patients ) or surgery alone ( 253 patients ) . Chemotherapy consisted of three preoperative and three postoperative cycles of intravenous epirubicin ( 50 mg per square meter of body-surface area ) and cisplatin ( 60 mg per square meter ) on day 1 , and a continuous intravenous infusion of fluorouracil ( 200 mg per square meter per day ) for 21 days . The primary end point was overall survival . RESULTS ECF-related adverse effects were similar to those previously reported among patients with advanced gastric cancer . Rates of postoperative complications were similar in the perioperative-chemotherapy group and the surgery group ( 46 percent and 45 percent , respectively ) , as were the numbers of deaths within 30 days after surgery . The resected tumors were significantly smaller and less advanced in the perioperative-chemotherapy group . With a median follow-up of four years , 149 patients in the perioperative-chemotherapy group and 170 in the surgery group had died . As compared with the surgery group , the perioperative-chemotherapy group had a higher likelihood of overall survival ( hazard ratio for death , 0.75 ; 95 percent confidence interval , 0.60 to 0.93 ; P=0.009 ; five-year survival rate , 36 percent vs. 23 percent ) and of progression-free survival ( hazard ratio for progression , 0.66 ; 95 percent confidence interval , 0.53 to 0.81 ; P patients with operable gastric or lower esophageal adenocarcinomas , a perioperative regimen of ECF decreased tumor size and stage and significantly improved progression-free and overall survival . ( Current Controlled Trials number , IS RCT N93793971 [ controlled-trials.com ] . )",
"BACKGROUND Vascular endothelial growth factor ( VEGF ) and VEGF receptor-2 (VEGFR-2)-mediated signalling and angiogenesis can contribute to the pathogenesis and progression of gastric cancer . We aim ed to assess whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , prolonged survival in patients with advanced gastric cancer . METHODS We did an international , r and omised , double-blind , placebo-controlled , phase 3 trial between Oct 6 , 2009 , and Jan 26 , 2012 , at 119 centres in 29 countries in North America , Central and South America , Europe , Asia , Australia , and Africa . Patients aged 24 - 87 years with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression after first-line platinum-containing or fluoropyrimidine-containing chemotherapy were r and omly assigned ( 2:1 ) , via a central interactive voice-response system , to receive best supportive care plus either ramucirumab 8 mg/kg or placebo , intravenously once every 2 weeks . The study sponsor , participants , and investigators were masked to treatment assignment . The primary endpoint was overall survival . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00917384 . FINDINGS 355 patients were assigned to receive ramucirumab ( n=238 ) or placebo ( n=117 ) . Median overall survival was 5·2 months ( IQR 2·3 - 9·9 ) in patients in the ramucirumab group and 3·8 months ( 1·7 - 7·1 ) in those in the placebo group ( hazard ratio [ HR ] 0·776 , 95 % CI 0·603 - 0·998 ; p=0·047 ) . The survival benefit with ramucirumab remained unchanged after multivariable adjustment for other prognostic factors ( multivariable HR 0·774 , 0·605 - 0·991 ; p=0·042 ) . Rates of hypertension were higher in the ramucirumab group than in the placebo group ( 38 [ 16 % ] vs nine [ 8 % ] ) , whereas rates of other adverse events were mostly similar between groups ( 223 [ 94 % ] vs 101 [ 88 % ] ) . Five ( 2 % ) deaths in the ramucirumab group and two ( 2 % ) in the placebo group were considered to be related to study drug . INTERPRETATION Ramucirumab is the first biological treatment given as a single drug that has survival benefits in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma progressing after first-line chemotherapy . Our findings vali date VEGFR-2 signalling as an important therapeutic target in advanced gastric cancer . FUNDING ImClone Systems",
"PURPOSE After curative resection , the prognosis of gastroesophageal adenocarcinoma is poor . This phase III trial was design ed to evaluate the benefit in overall survival ( OS ) of perioperative fluorouracil plus cisplatin in resectable gastroesophageal adenocarcinoma . PATIENTS AND METHODS Overall , 224 patients with resectable adenocarcinoma of the lower esophagus , gastroesophageal junction ( GEJ ) , or stomach were r and omly assigned to either perioperative chemotherapy and surgery ( CS group ; n = 113 ) or surgery alone ( S group ; n = 111 ) . Chemotherapy consisted of two or three preoperative cycles of intravenous cisplatin ( 100 mg/m(2 ) ) on day 1 , and a continuous intravenous infusion of fluorouracil ( 800 mg/m(2)/d ) for 5 consecutive days ( days 1 to 5 ) every 28 days and three or four postoperative cycles of the same regimen . The primary end point was OS . RESULTS Compared with the S group , the CS group had a better OS ( 5-year rate 38 % v 24 % ; hazard ratio [ HR ] for death : 0.69 ; 95 % CI , 0.50 to 0.95 ; P = .02 ) ; and a better disease-free survival ( 5-year rate : 34 % v 19 % ; HR , 0.65 ; 95 % CI , 0.48 to 0.89 ; P = .003 ) . In the multivariable analysis , the favorable prognostic factors for survival were perioperative chemotherapy ( P = .01 ) and stomach tumor localization ( P Perioperative chemotherapy significantly improved the curative resection rate ( 84 % v 73 % ; P = .04 ) . Grade 3 to 4 toxicity occurred in 38 % of CS patients ( mainly neutropenia ) but postoperative morbidity was similar in the two groups . CONCLUSION In patients with resectable adenocarcinoma of the lower esophagus , GEJ , or stomach , perioperative chemotherapy using fluorouracil plus cisplatin significantly increased the curative resection rate , disease-free survival , and OS",
"PURPOSE The Adjuvant Chemoradiotherapy in Stomach Tumors ( ARTIST ) trial tested whether the addition of radiotherapy to adjuvant chemotherapy improved disease-free survival ( DFS ) in patients with D2-resected gastric cancer ( GC ) . PATIENTS AND METHODS Between November 2004 and April 2008 , 458 patients with GC who received gastrectomy with D2 lymph node dissection were r and omly assigned to either six cycles of adjuvant chemotherapy with capecitabine and cisplatin ( XP ) or to two cycles of XP followed by chemoradiotherapy and then two additional cycles of XP ( XPRT ) . This final up date contains the first publication of overall survival ( OS ) , together with up date d DFS and subset analyses . RESULTS With 7 years of follow-up , DFS remained similar between treatment arms ( hazard ratio [ HR ] , 0.740 ; 95 % CI , 0.520 to 1.050 ; P=.0922 ) . OS also was similar ( HR , 1.130 ; 95 % CI , 0.775 to 1.647 ; P=.5272 ) . The effect of the addition of radiotherapy on DFS and OS differed by Lauren classification ( interaction P=.04 for DFS ; interaction P=.03 for OS ) and lymph node ratio ( interaction P improved DFS in patients with node-positive disease and with intestinal-type GC . There was a similar trend for DFS and OS by stage of disease . CONCLUSION In D2-resected GC , both adjuvant chemotherapy and chemoradiotherapy are tolerated and equally beneficial in preventing relapse . Because results suggest a significant DFS effect of chemoradiotherapy in subsets of patients , the ARTIST 2 trial evaluating adjuvant chemotherapy and chemoradiotherapy in patients with node-positive , D2-resected GC is under way",
"Surgical resection is the only curative treatment for gastric cancer . Postoperative outcomes may be affected by the average or total number of surgeries carried out at an institution ( hospital volume ) or by a surgeon ( surgeon volume ) . Among seven large‐scale studies that each enrolled over 10 000 patients who underwent gastrectomy , six showed that higher hospital volume contributed to a lower mortality rate after gastrectomy . Surgeon volume was also reported by three of four studies that each included over 1000 patients to be a significant factor contributing to heterogeneity in mortality rates after gastrectomy . In contrast , most studies showed no relationship between hospital volume and postoperative morbidity . A significant long‐term relationship was demonstrated in four of nine studies that each included more than 1000 patients , but the other five studies showed negative results . A recent correlative study of r and omized phase III trials for gastric cancer surgeries showed a significant relationship between hospital volume and postoperative morbidity in one trial but not in another trial . There was no correlation between overall survival and either hospital or surgeon volume . In addition , another correlative study of a phase III trial of r and omized chemotherapy for unresectable or recurrent gastric cancer found that there was no correlation between hospital volume and overall survival , although there was a large degree of heterogeneity in median overall survival among participating institutions",
"BACKGROUND Advanced gastric cancer can respond to S-1 , an oral fluoropyrimidine . We tested S-1 as adjuvant chemotherapy in patients with curatively resected gastric cancer . METHODS Patients in Japan with stage II or III gastric cancer who underwent gastrectomy with extended ( D2 ) lymph-node dissection were r and omly assigned to undergo surgery followed by adjuvant therapy with S-1 or to undergo surgery only . In the S-1 group , administration of S-1 was started within 6 weeks after surgery and continued for 1 year . The treatment regimen consisted of 6-week cycles in which , in principle , 80 mg of oral S-1 per square meter of body-surface area per day was given for 4 weeks and no chemotherapy was given for the following 2 weeks . The primary end point was overall survival . RESULTS We r and omly assigned 529 patients to the S-1 group and 530 patients to the surgery-only group between October 2001 and December 2004 . The trial was stopped on the recommendation of the independent data and safety monitoring committee , because the first interim analysis , performed 1 year after enrollment was completed , showed that the S-1 group had a higher rate of overall survival than the surgery-only group ( P=0.002 ) . Analysis of follow-up data showed that the 3-year overall survival rate was 80.1 % in the S-1 group and 70.1 % in the surgery-only group . The hazard ratio for death in the S-1 group , as compared with the surgery-only group , was 0.68 ( 95 % confidence interval , 0.52 to 0.87 ; P=0.003 ) . Adverse events of grade 3 or grade 4 ( defined according to the Common Toxicity Criteria of the National Cancer Institute ) that were relatively common in the S-1 group were anorexia ( 6.0 % ) , nausea ( 3.7 % ) , and diarrhea ( 3.1 % ) . CONCLUSIONS S-1 is an effective adjuvant treatment for East Asian patients who have undergone a D2 dissection for locally advanced gastric cancer . ( Clinical Trials.gov number , NCT00152217 [ Clinical Trials.gov ] . )",
"BACKGROUND Patients with advanced gastric or gastro-oesophageal junction cancer refractory to , or intolerant of , two or more previous regimens of chemotherapy have a poor prognosis , and current guidelines do not recommend any specific treatments for these patients . We assessed the efficacy and safety of nivolumab , a fully human IgG4 monoclonal antibody inhibitor of programmed death-1 ( PD-1 ) , in patients with advanced gastric or gastro-oesophageal junction cancer who had been previously been treated with two or more chemotherapy regimens . METHODS In this r and omised , double-blind , placebo-controlled , phase 3 trial done at 49 clinical sites in Japan , South Korea , and Taiwan , eligible patients ( aged ≥20 years with unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer refractory to , or intolerant of , st and ard therapy [ including two or more previous chemotherapy regimens ] , with an Eastern Cooperative Oncology Group [ ECOG ] performance status of 0 - 1 , and naive to anti-PD-1 therapy or other therapeutic antibodies and pharmacotherapies for the regulation of T cells ) were recruited . Patients were r and omly assigned ( 2:1 ) using an interactive web response system to receive 3 mg/kg nivolumab or placebo intravenously every 2 weeks , stratified by country , ECOG performance status , and number of organs with metastases . Study treatment was continued until progressive disease per investigator assessment or onset of toxicities requiring permanent discontinuation . Patients and investigators were masked to group assignment . The primary endpoint was overall survival in the intention-to-treat population . Safety was analysed in all patients who received at least one dose of study treatment . This study is ongoing but not recruiting new patients , and is registered with Clinical Trials.gov , number NCT02267343 . FINDINGS Between Nov 4 , 2014 , and Feb 26 , 2016 , we r and omly assigned 493 patients to receive nivolumab ( n=330 ) or placebo ( n=163 ) . At the data cutoff ( Aug 13 , 2016 ) , median follow-up in surviving patients was 8·87 months ( IQR 6·57 - 12·37 ) in the nivolumab group and 8·59 months ( 5·65 - 11·37 ) in the placebo group . Median overall survival was 5·26 months ( 95 % CI 4·60 - 6·37 ) in the nivolumab group and 4·14 months ( 3·42 - 4·86 ) in the placebo group ( hazard ratio 0·63 , 95 % CI 0·51 - 0·78 ; p rates were 26·2 % ( 95 % CI 20·7 - 32·0 ) with nivolumab and 10·9 % ( 6·2 - 17·0 ) with placebo . Grade 3 or 4 treatment-related adverse events occurred in 34 ( 10 % ) of 330 patients who received nivolumab and seven ( 4 % ) of 161 patients who received placebo ; treatment-related adverse events led to death in five ( 2 % ) of 330 patients in the nivolumab group and two ( 1 % ) of 161 patients in the placebo group . No new safety signals were observed . INTERPRETATION In this phase 3 study , the survival benefits indicate that nivolumab might be a new treatment option for heavily pretreated patients with advanced gastric or gastro-oesophageal junction cancer . Ongoing trials that include non-Asian patients are investigating nivolumab for advanced gastric or gastro-oesophageal junction cancer in various setting s and earlier treatment lines . FUNDING Ono Pharmaceutical and Bristol-Myers Squibb",
"BACKGROUND Patients with advanced gastric or gastro-oesophageal junction cancer that progresses on chemotherapy have poor outcomes . We compared pembrolizumab with paclitaxel in patients with advanced gastric or gastro-oesophageal junction cancer that progressed on first-line chemotherapy with a platinum and fluoropyrimidine . METHODS This r and omised , open-label , phase 3 study was done at 148 medical centres in 30 countries . Eligible patients were r and omised ( 1:1 ) in blocks of four per stratum with an interactive voice-response and integrated web-response system to receive either pembrolizumab 200 mg every 3 weeks for up to 2 years or st and ard-dose paclitaxel . Primary endpoints were overall survival and progression-free survival in patients with a programmed cell death lig and 1 ( PD-L1 ) combined positive score ( CPS ) of 1 or higher . Safety was assessed in all patients , irrespective of CPS . The significance threshold for overall survival was p=0·0135 ( one-sided ) . This trial is registered at Clinical Trials.gov , number NCT02370498 . FINDINGS Between June 4 , 2015 , and July 26 , 2016 , 592 patients were enrolled . Of the 395 patients who had a PD-L1 CPS of 1 or higher , 196 patients were assigned to receive pembrolizumab and 199 patients were assigned to receive paclitaxel . As of Oct 26 , 2017 , 326 patients in the population with CPS of 1 or higher had died ( 151 [ 77 % ] of 196 patients in the pembrolizumab group and 175 [ 88 % ] of 199 patients in the paclitaxel group ) . Median overall survival was 9·1 months ( 95 % CI 6·2 - 10·7 ) with pembrolizumab and 8·3 months ( 7·6 - 9·0 ) with paclitaxel ( hazard ratio [ HR ] 0·82 , 95 % CI 0·66 - 1·03 ; one-sided p=0·0421 ) . Median progression-free survival was 1·5 months ( 95 % CI 1·4 - 2·0 ) with pembrolizumab and 4·1 months ( 3·1 - 4·2 ) with paclitaxel ( HR 1·27 , 95 % CI 1·03 - 1·57 ) . In the total population , grade 3 - 5 treatment-related adverse events occurred in 42 ( 14 % ) of the 294 patients treated with pembrolizumab and 96 ( 35 % ) of the 276 patients treated with paclitaxel . INTERPRETATION Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher . Pembrolizumab had a better safety profile than paclitaxel . Additional trials of pembrolizumab in gastric and gastro-oesophageal cancer are ongoing . FUNDING Merck Sharp & Dohme , a subsidiary of Merck &",
"Abstract Background The application of ERAS protocol has widely gained acceptance after gastrointestinal surgery . Well- design ed , r and omized , control trials are needed to evaluate fully its safety and efficacy in the field of gastric cancer . This study aims to compare the enhanced recovery after surgery ( ERAS ) protocol and the conventional perioperative care program after totally laparoscopic distal gastrectomy ( TLDG ) in gastric cancer . Methods Patients with gastric cancer indicated for TLDG were r and omly assigned to either the ERAS group or the conventional group . The ERAS protocol included short fasting time , fluid restriction , early oral feeding , immediate mobilization , and use of epidural patient-controlled analgesia . Primary endpoint was recovery time , which was defined with the criteria of tolerable diet , safe ambulation , no requirement of additional analgesics , and afebrile state . Hospital stay , pain score , complications , and readmission rate were secondary endpoints . Results A total of 97 patients who underwent TLDG from October 2012 to August 2014 were enrolled ( ERAS = 46 , conventional = 51 ) . The ERAS group had faster recovery time ( 111.6 ± 34.3 vs. 126.7 ± 30.7 h ; p = 0.026 ) and significantly less pain through postoperative days 1–4 . Possible hospital stay also was faster in the ERAS group ( 5.0 ± 1.9 vs. 5.7 ± 1.6 days , p = 0.038 ) , but there was no difference in actual hospital stay . No difference was found in complication , and there was no mortality or readmission in both groups . Conclusions ERAS is safe and enhances postoperative recovery after TLDG in gastric cancer . Trial Registration The trial was registered in Clinical Trials.gov ( NCT01938313 )",
"Background With improved short-term surgical outcomes , laparoscopic distal gastrectomy has rapidly gained popularity . However , the safety and feasibility of laparoscopic total gastrectomy ( LTG ) has not yet been proven due to the difficulty of the technique . This single-arm prospect i ve multi-center study was conducted to evaluate the use of LTG for clinical stage I gastric cancer . Methods Between October 2012 and January 2014 , 170 patients with pathologically proven , clinical stage I gastric adenocarcinoma located at the proximal stomach were enrolled . Twenty-two experienced surgeons from 19 institutions participated in this clinical trial . The primary end point was the incidence of postoperative morbidity and mortality at postoperative 30 days . The severity of postoperative complications was categorized according to Clavien – Dindo classification , and the incidence of postoperative morbidity and mortality was compared with that in a historical control . Results Of the enrolled patients , 160 met criteria for inclusion in the full analysis set . Postoperative morbidity and mortality rates reached 20.6 % ( 33/160 ) and 0.6 % ( 1/160 ) , respectively . Fifteen patients ( 9.4 % ) had grade III or higher complications , and three reoperations ( 1.9 % ) were performed . The incidence of morbidity after LTG in this trial did not significantly differ from that reported in a previous study for open total gastrectomy ( 18 % ) . Conclusions LTG performed by experienced surgeons showed acceptable postoperative morbidity and mortality for patients with clinical stage I gastric cancer",
"Background Although radical surgery remains the cornerstone of cure in resectable gastric cancer , survival remains poor . Current evidence -based (neo)adjuvant strategies have shown to improve outcome , including perioperative chemotherapy , postoperative chemoradiotherapy and postoperative chemotherapy . However , these regimens suffer from poor patient compliance , particularly in the postoperative phase of treatment . The CRITICS-II trial aims to optimize preoperative treatment by comparing three treatment regimens : ( 1 ) chemotherapy , ( 2 ) chemotherapy followed by chemoradiotherapy and ( 3 ) chemoradiotherapy . Methods In this multicentre phase II non-comparative study , patients with clinical stage IB-IIIC ( TNM 8th edition ) resectable gastric adenocarcinoma are r and omised between : ( 1 ) 4 cycles of docetaxel+oxaliplatin+capecitabine ( DOC ) , ( 2 ) 2 cycles of DOC followed by chemoradiotherapy ( 45Gy in combination with weekly paclitaxel and carboplatin ) or ( 3 ) chemoradiotherapy . Primary endpoint is event-free survival , 1 year after r and omisation ( events are local and /or regional recurrence or progression , distant recurrence , or death from any cause ) . Secondary endpoints include : toxicity , surgical outcomes , percentage radical ( R0 ) resections , pathological tumour response , disease recurrence , overall survival , and health related quality of life . Exploratory endpoints include translational studies on predictive and prognostic biomarkers . Discussion The aim of this study is to select the most promising among three preoperative treatment arms in patients with resectable gastric adenocarcinoma . This treatment regimen will subsequently be compared with the st and ard therapy in a phase III trial . Trial registration clinical trials.gov NCT02931890 ; registered 13 October 2016 . Date of first enrolment : 21 December 2017",
"Objective The st and ard treatment for patients with locally advanced gastric cancer has relied on perioperative radio-chemotherapy or chemotherapy and surgery . The aim of this study was to investigate the wealth of radiomics for pre-treatment computed tomography ( CT ) in the prediction of the pathological response of locally advanced gastric cancer with preoperative chemotherapy . Methods Thirty consecutive patients with CT-staged II/III gastric cancer receiving neoadjuvant chemotherapy were enrolled in this study between December 2014 and March 2017 . All patients underwent upper abdominal CT during the unenhanced , late arterial phase ( AP ) and portal venous phase ( PP ) before the administration of neoadjuvant chemotherapy . In total , 19,985 radiomics features were extracted in the AP and PP for each patient . Four methods were adopted during feature selection and eight methods were used in the process of building the classifier model . Thirty-two combinations of feature selection and classification methods were examined . Receiver operating characteristic ( ROC ) curves were used to evaluate the capability of each combination of feature selection and classification method to predict a non-good response ( non-GR ) based on tumor regression grade ( TRG ) . Results The mean area under the curve ( AUC ) ranged from 0.194 to 0.621 in the AP , and from 0.455 to 0.722 in the PP , according to different combinations of feature selection and the classification methods . There was only one cross-combination machine-learning method indicating a relatively higher AUC ( > 0.600 ) in the AP , while 12 cross-combination machine-learning methods presented relatively higher AUCs ( all > 0.600 ) in the PP . The feature selection method adopted by a filter based on linear discriminant analysis + classifier of r and om forest achieved a significantly prognostic performance in the PP ( AUC , 0.722±0.108 ; accuracy , 0.793 ; sensitivity , 0.636 ; specificity , 0.889 ; Z=2.039 ; P=0.041 ) . Conclusions It is possible to predict non-GR after neoadjuvant chemotherapy in locally advanced gastric cancers based on the radiomics of CT",
"Importance Fluorescent imaging with indocyanine green can be used to visualize lymphatics . Peritumoral injection of indocyanine green may allow for visualization of every draining lymph node from a primary lesion on near-infrared imaging . Objectives To evaluate the role of fluorescent lymphography using near-infrared imaging as an intraoperative tool for achieving complete lymph node dissection and compare the number of lymph nodes retrieved with the use of near-infrared imaging and the number of lymph nodes retrieved without the use of near-infrared imaging . Design , Setting , and Participants This prospect i ve single-arm study was conducted among 40 patients who underwent robotic gastrectomy between August 30 , 2013 , and July 21 , 2014 , at a single-center , tertiary referral teaching hospital . After propensity score matching , the results of these 40 patients were compared with the results of 40 historical control patients who underwent robotic gastrectomy without indocyanine green injection between January 1 , 2012 , and August 31 , 2013 . Statistical analysis was performed from January 1 , 2015 , to July 31 , 2016 . Interventions Robotic gastrectomy with systemic lymphadenectomy and retrieval of lymph nodes under near-infrared imaging after peritumoral injection of indocyanine green to the submucosal layer 1 day before surgery . Main Outcomes and Measures The primary outcome was the number of retrieved lymph nodes in each nodal station . Results Among the 40 patients in the study ( 19 women and 21 men ; mean [ SD ] age , 52.2 [ 11.7 ] years ) , no complications related to indocyanine green injection or near-infrared imaging were observed . On completion of the lymphadenectomy , the absence of fluorescent lymph nodes in the dissected area was confirmed . A mean ( SD ) total of 23.9 ( 9.0 ) fluorescent lymph nodes were recorded among a mean ( SD ) total of 48.9 ( 14.6 ) overall lymph nodes retrieved . The mean number of overall lymph nodes retrieved was larger in the near-infrared group than in the historical controls ( 48.9 vs 35.2 ; P number of lymph nodes retrieved at stations 2 , 6 , 7 , 8 , and 9 . In the near-infrared group , 5 patients exhibited lymph node metastases , and all metastatic lymph nodes were fluorescent . Conclusions and Relevance This study ’s findings suggest that fluorescent lymphography may be useful intraoperatively for identifying and retrieving all necessary lymph nodes for a complete and thorough lymphadenectomy",
"BACKGROUND Anastomotic leakage is a severe complication after gastric cancer surgery . Inadequate blood supply is regarded as an important risk factor . The aim of the study was to evaluate the feasibility and usefulness of intraoperative assessment of anastomotic vascular perfusion in gastric cancer surgery using near-infrared ( NIR ) camera imaging with indocyanine green (ICG)-enhanced fluorescence technique . MATERIAL S AND METHODS From March 2015 to 2016 , 30 patients undergoing laparoscopic gastrectomy for gastric cancer were prospect ively evaluated . After completing the anastomosis , 2.5 - 5.0 mg of ICG was injected via peripheral veins . All anastomoses and resection margins were investigated using NIR camera to assess anastomotic perfusion . The assessment was performed using the adopted perfusion score of fluorescence activity , which ranged from 1 to 5 ( 1 = no uptake , and 5 = iso-fluorescent to all other segments ) . RESULTS Twenty-six distal gastrectomy ( 20 gastroduodenostomies , 6 gastrojejunostomies ) , 3 total gastrectomies ( TG ) , and 1 pylorus-preserving gastrectomy were performed . The gap of visualization was 4.1 ± 3.2 minutes ( range , 2 - 15 ) after ICG injection . Twenty-three of 30 patients ( 76.7 % ) showed technically successful ICG visualization . Among gastroduodenostomies , the average scores for gastric and duodenal sides were 3.5 and 3.7 . Among gastrojejunostomies , the average scores for gastric , jejunal , and duodenal stump sides were 3.5 , 4.0 , and 3.8 ( jejunojejunostomy , 3.5 ) . Among TG , the average scores for esophagojejunostomy , duodenal stump , and jejunojejunostomy were 3.7 , 4.0 , 4.0 , and 4.7 . One case of leakage occurred in this study . Other complications included fluid collection and stenosis in 1 patient each . CONCLUSIONS This study showed intraoperative ICG angiography using NIR camera is feasible and provides imaging of anastomotic blood flow . Further studies are needed for practice",
"Importance Laparoscopic distal gastrectomy is gaining popularity over open distal gastrectomy for gastric cancer because of better early postoperative outcomes . However , to our knowledge , no studies have proved whether laparoscopic distal gastrectomy is oncologically equivalent to open distal gastrectomy . Objective To examine whether the long-term survival among patients with stage I gastric cancer undergoing laparoscopic distal gastrectomy is noninferior to that among patients undergoing open distal gastrectomy . Design The Korean Laparoendoscopic Gastrointestinal Surgery Study ( KLASS ) group , which includes 15 surgeons from 13 institutes , conducted a phase 3 , multicenter , open-label , noninferiority , prospect i ve r and omized clinical trial ( KLASS-01 ) of patients with histologically proven , preoperative clinical stage I gastric adenocarcinoma from January 5 , 2006 , to August 23 , 2010 . Survival and recurrence status of the patients was determined in December 2016 . Interventions Patients were r and omly assigned ( 1:1 ) to laparoscopic distal gastrectomy ( n = 705 ) or open distal gastrectomy ( n = 711 ) . Of these patients , 85 received a surgical approach opposite the one to which they were r and omized ( 63 r and omized to the open surgery group and 22 to the laparoscopic group ) . Main Outcomes and Measures Difference in 5-year overall survival between the laparoscopic and open distal gastrectomy groups . The noninferiority margin was prespecified as −5 % ( corresponding hazard ratio of 1.54 ) , with an assumed survival of 90 % after 5 years in the open surgery group . Results Among the 1416 patients ( mean [ SD ] age , 57.3 [ 11.1 ] years ; 940 [ 66.4 % ] male ) included in the study , the 5-year overall survival rates were 94.2 % in the laparoscopic group and 93.3 % in the open surgery group ( log-rank P = .64 ) . Intention-to-treat analysis confirmed the noninferiority of the laparoscopic approach compared with the open approach ( difference , 0.9 percentage points ; 1-sided 97.5 % CI , −1.6 to infinity ) . The 5-year cancer-specific survival rates were similar between the 2 groups ( 97.1 % in the laparoscopic group and 97.2 % in the open surgery group , log-rank P = .91 ; difference , −0.03 percentage points ; 1-sided 97.5 % CI , −1.8 to infinity ) . Per- protocol analysis results were consistent with the intention-to-treat results for overall and cancer-specific survival rates . Conclusions and Relevance The KLASS-01 trial revealed similar overall and cancer-specific survival rates between patients receiving laparoscopic and open distal gastrectomy . Laparoscopic distal gastrectomy is an oncologically safe alternative to open surgery for stage I gastric cancer . Trial Registration Clinical Trials.gov identifier :",
"BACKGROUND Surgical resection is the only curative treatment option for gastric cancer . Despite widespread adoption of multimodality perioperative treatment strategies , 5-year overall survival rates remain low . In patients with advanced gastric or gastroesophageal junction adenocarcinoma , pembrolizumab has demonstrated promising efficacy and manageable safety as monotherapy in previously treated patients and as first-line therapy in combination with cisplatin and 5-fluorouracil . Combining chemotherapy with pembrolizumab in the neoadjuvant/adjuvant setting may benefit patients with locally advanced , resectable disease . AIM To describe the design and rationale for the global , multicenter , r and omized , double-blind , Phase III KEYNOTE-585 study to evaluate the efficacy and safety of pembrolizumab plus chemotherapy compared with placebo plus chemotherapy as neoadjuvant/adjuvant treatment for localized gastric or gastroesophageal junction adenocarcinoma . Clinical Trials.gov : NCT03221426",
"Background The multicohort , phase II , nonr and omized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer . Results from cohorts 2 and 3 , evaluating first-line therapy , are presented . Methods Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma . Cohort 3 ( monotherapy ) had programmed death receptor 1 combined positive score ≥ 1 . Cohort 2 ( combination therapy ) received pembrolizumab 200 mg on day 1 , cisplatin 80 mg/m2 on day 1 ( up to 6 cycles ) , and 5-fluorouracil 800 mg/m2 on days 1–5 of each 3-week cycle ( or capecitabine 1000 mg/m2 twice daily in Japan ) . Primary end points were safety ( combination therapy ) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review , and safety ( monotherapy ) . Results In the combination therapy and monotherapy cohorts , 25 and 31 patients were enrolled ; median follow-up was 13.8 months ( range 1.8–24.1 ) and 17.5 months ( range 1.7–20.7 ) , respectively . In the combination therapy cohort , grade 3/4 treatment-related adverse events occurred in 19 patients ( 76.0 % ) ; none were fatal . In the monotherapy cohort , grade 3–5 treatment-related adverse events occurred in seven patients ( 22.6 % ) ; one death was attributed to a treatment-related adverse event ( pneumonitis ) . The objective response rate was 60.0 % [ 95 % confidence interval ( CI ) , 38.7–78.9 ] ( combination therapy ) and 25.8 % ( 95 % CI 11.9–44.6 ) ( monotherapy ) . Conclusions Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma . Clinical Trial Clinical Trials.gov",
"PURPOSE S-1 is a st and ard postoperative adjuvant chemotherapy for patients with stage II or III gastric cancer in Asia . Neoadjuvant or perioperative strategies dominate in Western countries , and docetaxel has recently shown significant survival benefits when combined with other st and ard regimens in advanced cancer and perioperative setting s. PATIENTS AND METHODS This r and omized phase III study was design ed to prove the superiority of postoperative S-1 plus docetaxel over S-1 alone for R0 resection of pathologic stage III gastric cancer . The sample size of 1,100 patients was necessary to detect a 7 % increase in 3-year relapse-free survival as the primary end point ( hazard ratio , 0.78 ; 2-sided α = .05 ; β = .2 ) . RESULTS The second interim analysis was conducted when the number of events reached 216 among 915 enrolled patients ( median follow-up , 12.5 months ) . Analysis demonstrated the superiority of S-1 plus docetaxel ( 66 % ) to S-1 ( 50 % ) for 3-year relapse-free survival ( hazard ratio , 0.632 ; 99.99 % CI , 0.400 to 0.998 ; stratified log-rank test , P of grade 3 or greater adverse events , particularly neutropenia and leukopenia , were higher in the S-1 plus docetaxel group , but all events were manageable . CONCLUSION Addition of docetaxel to S-1 is effective with few safety concerns in patients with stage III gastric cancer . The present findings may also be applicable in countries in which perioperative adjuvant chemotherapy or chemoradiation is not st and ard",
"BACKGROUND Docetaxel-based chemotherapy is effective in metastatic gastric and gastro-oesophageal junction adenocarcinoma . This study reports on the safety and efficacy of the docetaxel-based triplet FLOT ( fluorouracil plus leucovorin , oxaliplatin and docetaxel ) as a perioperative therapy for patients with locally advanced , resectable tumours . METHODS In this controlled , open-label , phase 2/3 trial , we r and omly assigned 716 patients with histologically-confirmed advanced clinical stage cT2 or higher or nodal positive stage ( cN+ ) , or both , resectable tumours , with no evidence of distant metastases , via central interactive web-based-response system , to receive either three pre-operative and three postoperative 3-week cycles of 50 mg/m2 epirubicin and 60 mg/m2 cisplatin on day 1 plus either 200 mg/m2 fluorouracil as continuous intravenous infusion or 1250 mg/m2 capecitabine orally on days 1 to 21 ( ECF/ECX ; control group ) or four preoperative and four postoperative 2-week cycles of 50 mg/m2 docetaxel , 85 mg/m2 oxaliplatin , 200 mg/m2 leucovorin and 2600 mg/m2 fluorouracil as 24-h infusion on day 1 ( FLOT ; experimental group ) . The primary outcome of the trial was overall survival ( superiority ) analysed in the intention-to-treat population . This trial is registered with Clinical Trials.gov , number NCT01216644 . FINDINGS Between Aug 8 , 2010 , and Feb 10 , 2015 , 716 patients were r and omly assigned to treatment in 38 German hospitals or with practice -based oncologists . 360 patients were assigned to ECF/ECX and 356 patients to FLOT . Overall survival was increased in the FLOT group compared with the ECF/ECX group ( hazard ratio [ HR ] 0·77 ; 95 % confidence interval [ CI ; 0.63 to 0·94 ] ; median overall survival , 50 months [ 38·33 to not reached ] vs 35 months [ 27·35 to 46·26 ] ) . The number of patients with related serious adverse events ( including those occurring during hospital stay for surgery ) was similar in the two groups ( 96 [ 27 % ] in the ECF/ECX group vs 97 [ 27 % ] in the FLOT group ) , as was the number of toxic deaths ( two [ both groups ) . Hospitalisation for toxicity occurred in 94 patients ( 26 % ) in the ECF/ECX group and 89 patients ( 25 % ) in the FLOT group . INTERPRETATION In locally advanced , resectable gastric or gastro-oesophageal junction adenocarcinoma , perioperative FLOT improved overall survival compared with perioperative ECF/ECX . FUNDING The German Cancer Aid ( Deutsche Krebshilfe ) , Sanofi-Aventis , Chugai , and Stiftung Leben mit Krebs Foundation",
"Background At present , palliative systemic chemotherapy is the st and ard treatment in the Netherl and s for gastric cancer patients with peritoneal dissemination . In contrast to lymphatic and haematogenous dissemination , peritoneal dissemination may be regarded as locoregional spread of disease . Administering cytotoxic drugs directly into the peritoneal cavity has an advantage over systemic chemotherapy since high concentrations can be delivered directly into the peritoneal cavity with limited systemic toxicity . The combination of a radical gastrectomy with cytoreductive surgery ( CRS ) and hyperthermic intraperitoneal chemotherapy ( HIPEC ) has shown promising results in patients with gastric cancer in Asia . However , the results obtained in Asian patients can not be extrapolated to Western patients .The aim of this study is to compare the overall survival between patients with gastric cancer with limited peritoneal dissemination and /or tumour positive peritoneal cytology treated with palliative systemic chemotherapy , and those treated with gastrectomy , CRS and HIPEC after neoadjuvant systemic chemotherapy . Methods In this multicentre r and omised controlled two-armed phase III trial , 106 patients will be r and omised ( 1:1 ) between palliative systemic chemotherapy only ( st and ard treatment ) and gastrectomy , CRS and HIPEC ( experimental treatment ) after 3–4 cycles of systemic chemotherapy . Patients with gastric cancer are eligible for inclusion if ( 1 ) the primary cT3-cT4 gastric tumour including regional lymph nodes is considered to be resectable , ( 2 ) limited peritoneal dissemination ( Peritoneal Cancer Index systemic chemotherapy was given ( prior to inclusion ) without disease progression . Discussion The PERISCOPE II study will determine whether gastric cancer patients with limited peritoneal dissemination and /or tumour positive peritoneal cytology treated with systemic chemotherapy , gastrectomy , CRS and HIPEC have a survival benefit over patients treated with palliative systemic chemotherapy only . Trial registration clinical trials.gov NCT03348150 ; registration date November 2017 ; first enrolment November 2017 ; expected end date December 2022 ; trial status : Ongoing",
"We determined the effects of enhanced recovery after surgery ( ERAS ) in patients undergoing radical surgery for gastric carcinoma . Sixty patients undergoing radical gastrectomy for gastric carcinoma in Lishui Hospital between March and October 2016 were r and omized to receive either ERAS ( 30 patients ) or conventional care ( 30 patients , controls ) . Clinical , economic , and laboratory indices were analyzed . ERAS patients showed faster recovery and shorter postoperative hospital stays than the controls ( P time to first flatus and defecation , time to removal of drainage tubes , time to resumption of oral feeding , time to postoperative mobilization , and postoperative complications ) were significantly better in ERAS patients than in controls . Duration of postoperative infusion was lower in ERAS patients than in controls ( P serum albumin and prealbumin were higher on postoperative day 7 , C-reactive protein was lower on postoperative days 3 and 7 , and neutrophil count was lower on postoperative day 3 compared to the values in controls ( P IgM levels were higher in ERAS patients on postoperative days 3 and 7 ( P IgG levels were higher on postoperative day 3 ( P Total T lymphocytes were higher in ERAS patients on postoperative day 3 , while helper T cells and CD4+/CD8 + ratio were higher on postoperative days 3 and 7 ( P gastric carcinoma patients , ERAS may reduce perioperative inflammation , improve immunity and postoperative nutrition , shorten hospitalization , and enhance rehabilitation",
"Importance Laparoscopic distal gastrectomy is accepted as a more effective approach to conventional open distal gastrectomy for early-stage gastric cancer . However , efficacy for locally advanced gastric cancer remains uncertain . Objective To compare 3-year disease-free survival for patients with locally advanced gastric cancer after laparoscopic distal gastrectomy or open distal gastrectomy . Design , Setting , and Patients The study was a noninferiority , open-label , r and omized clinical trial at 14 centers in China . A total of 1056 eligible patients with clinical stage T2 , T3 , or T4a gastric cancer without bulky nodes or distant metastases were enrolled from September 2012 to December 2014 . Final follow-up was on December 31 , 2017 . Interventions Participants were r and omized in a 1:1 ratio after stratification by site , age , cancer stage , and histology to undergo either laparoscopic distal gastrectomy ( n = 528 ) or open distal gastrectomy ( n = 528 ) with D2 lymphadenectomy . Main Outcomes and Measures The primary end point was 3-year disease-free survival with a noninferiority margin of -10 % to compare laparoscopic distal gastrectomy with open distal gastrectomy . Secondary end points of 3-year overall survival and recurrence patterns were tested for superiority . Results Among 1056 patients , 1039 ( 98.4 % ; mean age , 56.2 years ; 313 [ 30.1 % ] women ) had surgery ( laparoscopic distal gastrectomy [ n=519 ] vs open distal gastrectomy [ n=520 ] ) , and 999 ( 94.6 % ) completed the study . Three-year disease-free survival rate was 76.5 % in the laparoscopic distal gastrectomy group and 77.8 % in the open distal gastrectomy group , absolute difference of -1.3 % and a 1-sided 97.5 % CI of -6.5 % to ∞ , not crossing the prespecified noninferiority margin . Three-year overall survival rate ( laparoscopic distal gastrectomy vs open distal gastrectomy : 83.1 % vs 85.2 % ; adjusted hazard ratio , 1.19 ; 95 % CI , 0.87 to 1.64 ; P = .28 ) and cumulative incidence of recurrence over the 3-year period ( laparoscopic distal gastrectomy vs open distal gastrectomy : 18.8 % vs 16.5 % ; subhazard ratio , 1.15 ; 95 % CI , 0.86 to 1.54 ; P = .35 ) did not significantly differ between laparoscopic distal gastrectomy and open distal gastrectomy groups . Conclusions and Relevance Among patients with a preoperative clinical stage indicating locally advanced gastric cancer , laparoscopic distal gastrectomy , compared with open distal gastrectomy , did not result in inferior disease-free survival at 3 years . Trial Registration Clinical Trials.gov Identifier : NCT01609309",
"Objectives : The aim of this study is to explore the safety and feasibility of early oral feeding ( EOF ) on short-term postoperative outcomes . Trial design : A prospect i ve r and omized non-inferiority trial . Material s and methods : From August 27 , 2015 to March 31 , 2017 , 100 consecutive patients with gastric cancer in Xijing Hospital were recruited . Patients undergoing total laparoscopic radical gastrectomy ( TLRG ) received either EOF group or delayed oral feeding ( DOF group ) . The endpoints were anastomotic leakage , the recovery of bowel function , the postoperative complications and costs . The process of r and omization used a computer-generated sequence that was kept in a sealed envelope by a nurse that did not participate in the trial . None of the participants , administrators of interventions and those assessing outcomes was blinded . Results : Ultimately , 51 patients were in EOF group and 49 in DOF group , which both are comparable . The postoperative hospital stay in EOF group was significantly lower than DOF group ( 5.18±1.47 days vs 6.18±2.46 days , P=0.016 ) . Furthermore , there was a trend for a reduction in the time of first flatus ( 10.3 hrs ) and defecation ( 12.7 hrs ) in EOF group compared to DOF group , but it was not statistically significant . Meanwhile , there were no significant differences in postoperative complications between two groups . One patient in the EOF group developed a fistula in the surgical remnant , which was recorded as other leakages ; there was no difference between the two groups ( P=0.582 ) . Conclusion : EOF does not seem to be more harmful than DOF , and might significantly improve the short-term outcomes for patients receiving TLRG",
"Background To investigate the implication s of prophylactic intraoperative Hyperthermic Intraperitoneal Chemotherapy ( HIPEC ) with D2 radical gastrectomy for locally advanced Gastric Cancer ( AGC ) in a r and omized case control study . Method Eighty consecutive patients with locally AGC were r and omly separated into 2 groups : HIPEC group ( Curative Resection + intraoperative HIPEC with cisplatin 50 mg/m2 at 42.0 ± 1.0 ° C for 60 min ) and Control group ( Curative Resection only ) . Intraoperative and post-operative events , clinical recovery , morbidity and the disease-free survival ( DFS ) rates were closely monitored . Results Faster recovery of bowel function ( 43 ± 5 h vs 68 ± 7 , P and shorter postoperative stay ( 8d vs 14d , P the HIPEC group . Among the 40 HIPEC group patients , the highest intracranial temperature recorded during the procedure was 38.2 ° C but the patient made an eventless recovery . Mild renal dysfunction , hyperbilirubinemia and mild liver dysfunction were recorded in the HIPEC group but their incidences were found to be statistically insignificant when compared with the control group ( P > 0.05 ) . The 3 year DFS rate analysis showed that the prophylactic HIPEC group had a higher DFS rate ( 93 % vs 65 % , P = 0.0054 ) . The peritoneal recurrence rate was lower in the HIPEC group ( 3 % vs 23 % , P ) . Conclusion Prophylactic HIPEC with radical D2 Gastrectomy improves survival and peritoneal recurrence rates for AGC with favorable post-operative recovery at low and acceptable morbidity",
"BACKGROUND Upper gastrointestinal cancers ( including oesophageal cancer and gastric cancer ) are the most common cancers worldwide . Artificial intelligence platforms using deep learning algorithms have made remarkable progress in medical imaging but their application in upper gastrointestinal cancers has been limited . We aim ed to develop and vali date the Gastrointestinal Artificial Intelligence Diagnostic System ( GRAIDS ) for the diagnosis of upper gastrointestinal cancers through analysis of imaging data from clinical endoscopies . METHODS This multicentre , case-control , diagnostic study was done in six hospitals of different tiers ( ie , municipal , provincial , and national ) in China . The images of consecutive participants , aged 18 years or older , who had not had a previous endoscopy were retrieved from all participating hospitals . All patients with upper gastrointestinal cancer lesions ( including oesophageal cancer and gastric cancer ) that were histologically proven malignancies were eligible for this study . Only images with st and ard white light were deemed eligible . The images from Sun Yat-sen University Cancer Center were r and omly assigned ( 8:1:1 ) to the training and intrinsic verification data sets for developing GRAIDS , and the internal validation data set for evaluating the performance of GRAIDS . Its diagnostic performance was evaluated using an internal and prospect i ve validation set from Sun Yat-sen University Cancer Center ( a national hospital ) and additional external validation sets from five primary care hospitals . The performance of GRAIDS was also compared with endoscopists with three degrees of expertise : expert , competent , and trainee . The diagnostic accuracy , sensitivity , specificity , positive predictive value , and negative predictive value of GRAIDS and endoscopists for the identification of cancerous lesions were evaluated by calculating the 95 % CIs using the Clopper-Pearson method . FINDINGS 1 036 496 endoscopy images from 84 424 individuals were used to develop and test GRAIDS . The diagnostic accuracy in identifying upper gastrointestinal cancers was 0·955 ( 95 % CI 0·952 - 0·957 ) in the internal validation set , 0·927 ( 0·925 - 0·929 ) in the prospect i ve set , and ranged from 0·915 ( 0·913 - 0·917 ) to 0·977 ( 0·977 - 0·978 ) in the five external validation sets . GRAIDS achieved diagnostic sensitivity similar to that of the expert endoscopist ( 0·942 [ 95 % CI 0·924 - 0·957 ] vs 0·945 [ 0·927 - 0·959 ] ; p=0·692 ) and superior sensitivity compared with competent ( 0·858 [ 0·832 - 0·880 ] , p The positive predictive value was 0·814 ( 95 % CI 0·788 - 0·838 ) for GRAIDS , 0·932 ( 0·913 - 0·948 ) for the expert endoscopist , 0·974 ( 0·960 - 0·984 ) for the competent endoscopist , and 0·824 ( 0·795 - 0·850 ) for the trainee endoscopist . The negative predictive value was 0·978 ( 95 % CI 0·971 - 0·984 ) for GRAIDS , 0·980 ( 0·974 - 0·985 ) for the expert endoscopist , 0·951 ( 0·942 - 0·959 ) for the competent endoscopist , and 0·904 ( 0·893 - 0·916 ) for the trainee endoscopist . INTERPRETATION GRAIDS achieved high diagnostic accuracy in detecting upper gastrointestinal cancers , with sensitivity similar to that of expert endoscopists and was superior to that of non-expert endoscopists . This system could assist community-based hospitals in improving their effectiveness in upper gastrointestinal cancer diagnoses . FUNDING The National Key R&D Program of China , the Natural Science Foundation of Guangdong Province , the Science and Technology Program of Guangdong , the Science and Technology Program of Guangzhou , and the Fundamental Research Funds for the Central Universities",
"BACKGROUND The prognosis for stage III gastric cancer is unsatisfactory by D2 gastrectomy and S-1 adjuvant chemotherapy . Both S-1 plus cisplatin ( SC ) and paclitaxel plus cisplatin ( PC ) are promising regimens as neoadjuvant chemotherapy ; however , the optimal duration remains unclear . PATIENTS AND METHODS In this 2 × 2 r and omised phase II trial , stage III gastric cancer patients , those with a prognosis corresponding to stage III , and macroscopically resectable stage IV cases were r and omised to two or four courses of S-1 ( 80 mg/m(2 ) for 21 d with 1 week rest)/cisplatin ( 60 mg/m(2 ) at day 8) or PC ( 80 and 25 mg/m(2 ) , respectively , on days 1 , 8 , and 15 with 1 week rest ) as neoadjuvant chemotherapy . The primary end-point was the 3-year overall survival ( OS ) . RESULTS Between October 2009 and July 2011 , 83 patients received 2 courses of SC ( n=21 ) , 4 courses of SC ( n=20 ) , 2 courses of PC ( n=21 ) and 4 courses of PC ( n=21 ) . The 3-year OS was 60.9 % for SC and 64.3 % for PC and 64.3 % for the two courses and 61.0 % for the four courses . Subset analyses demonstrated no subgroup which showed any potential survival benefit by PC in comparison to SC or by four courses as in comparison to two courses . CONCLUSIONS Two courses of SC as neoadjuvant chemotherapy are recommended as a test arm of a future phase III study for patients with locally advanced gastric cancer . CLINICAL TRIAL NUMBER UMIN-000002595"
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After more than three decades of clinical trials testing various st and ard-dose chemotherapy regimens , the disease course of patients with multiple myeloma has not changed appreciably . Conventional chemotherapy can provide effective palliation but is not curative ( 1 ) . Case series have described encouraging results in patients with myeloma undergoing allogeneic or autologous bone marrow or peripheral blood stem-cell transplantation ( 2 ) . Other studies of transplantation , including r and omized trials , have been reported in the past 6 years ( 3 , 4 ) . To facilitate decisions about treatment options , practice guidelines have been developed for use by health care providers and consumers . In Ontario , Canada , cancer treatments and policies are led by a state-funded organization , Cancer Care Ontario . To help derive treatment options , Cancer Care Ontario has developed the Program in Evidence -Based Care , which includes the Practice Guidelines Initiative . Disease Site Groups ( DSGs ) , which comprise physicians , epidemiologists , and consumers , develop guidelines through a systematic process that involves assessment of evidence , consensus , and a validation process involving practitioners from across the province . Guideline topics are chosen through a prioritization process that includes the burden of illness , availability of evidence , perceived variation in practice , the potential to affect treatment decisions , and re source utilization . The Hematology DSG noted that the use of transplantation for patients with myeloma varied among practice s across the province . Variability in practice and emerging evidence of higher quality made this a priority topic for guideline development . To approach this topic , the DSG addressed the following questions : What is optimal st and ard-dose chemotherapy for patients with myeloma ? In terms of survival , is peripheral blood stem-cell or marrow transplantation better than conventional chemotherapy ? What is the relative efficacy of autologous versus allogeneic transplantation ? What specifics of the transplantation process can be recommended ? When should transplantation be performed ? Who should ( or should not ) receive a transplant ? Methods Overview of Guideline Development This guideline was developed by the Cancer Care Ontario Practice Guidelines Initiative ( CCOPGI ) using the methods of the Practice Guidelines Development Cycle ( 5 ) . Members of the CCOPGI 's Hematology DSG selected , review ed , and interpreted the evidence . This DSG comprises 25 members , including hematologists , medical and radiation oncologists , an epidemiologist , and 2 lay representatives . Several of the physician members have background training in epidemiology ; 8 hematologists regularly perform stem-cell transplantation in clinical practice . The DSG 's draft recommendations were circulated through a mailed survey to hematologists and medical or radiation oncologists in Ontario for feedback and involvement in a consensus process . Responses were used to guide the reformatting of the draft into the final guideline recommendations . The Practice Guidelines Co-ordinating Committee ( PGCC ) , which ensures consistency of guideline development across the DSGs of various tumor sites , approved the guideline . The CCOPGI has a st and ardized process to up date each guideline report ; the current guideline was up date d and review ed by the PGCC in October 2000 . Literature Search Strategy We search ed the MEDLINE , CANCERLIT , and Cochrane Library data bases for literature published from 1992 to December 1997 and subsequently up date d the search in October 1998 , June 1999 , and April 2000 . For the search es , we combined multiple myeloma ( as a Medical Subject Heading [ MeSH ] and text word ) with bone marrow transplantation ( MeSH and text word ) and drug therapy ( MeSH ) . Then , we combined these terms with the search terms for the following study design s : practice guidelines ; systematic review s or meta-analyses ; review s ; r and omized , controlled trials ; controlled clinical trials ; and comparative studies . In addition , we search ed the PubMed and Physician Data Query ( PDQ ) ( www.cancer.gov/ search / clinical _ trials/ ) data bases and review ed relevant conference proceedings ( American Society of Hematology , 1997 to 1999 , and American Society of Clinical Oncology , 1999 to 2000 ) , article bibliographies , and personal files . To address the issue of optimal chemotherapy , we performed an additional search of the same data bases using the term multiple myeloma ( MeSH ) combined with r and omized , controlled trials ( MeSH ) and the text word r and om in the title . Inclusion Criteria We selected study reports meeting one of the three following criteria : r and omized trial or meta- analysis of therapy for patients with myeloma that reported survival or quality -of-life outcomes ; nonr and omized comparative trial that addressed transplantation strategy , including a contemporaneous control group , and that reported survival or quality -of-life outcomes ; or economic evaluation that addressed transplantation strategy . Because of insufficient data on the specifics of the transplantation process and the patients who would be most likely to benefit from transplantation , we performed a second search , which identified data from noncomparative case-series studies . Data Extraction and Interpretative Summary Three members of the DSG , including an epidemiologist , determined eligibility of the articles and abstract s obtained from the literature search . The lead DSG member for this guideline extracted and summarized relevant data according to the guideline question addressed . The DSG members then review ed the summarized data and key articles . The DSG met formally three to four times annually ; at these meetings , the members method ologically assessed the articles , interpreted the data , and debated specific points in an attempt to reach a consensus . Synthesizing the Evidence Because all of the nine r and omized trials on transplantation addressed different questions , we did not statistically pool the data . DSG Consensus Process Through an iterative process that included debate at formal meetings and circulation of draft recommendations , we considered the implication s of the appraised data for each guideline question . With this process , attempts were made to reach consensus ; when this was impossible , minority opinions were recorded . Approval by each member of the DSG was required before circulation of the draft version for practitioner feedback and su bmi ssion of the final guideline to the PGCC . Practitioner Feedback To obtain practitioner feedback , we mailed a survey to 211 practitioners in Ontario ( 94 hematologists , 93 medical oncologists , and 24 radiation oncologists ) . The survey consisted of st and ardized items asking the practitioner to rate the quality of each draft guideline and to judge whether the draft recommendations should serve as a practice guideline . Written comments were invited . Follow-up reminders were sent at 2 weeks ( by postcard ) and 4 weeks ( entire package ) . After exclusion of 18 retired practitioners , 137 of 193 practitioners ( 71 % ) responded ; 90 of 137 respondents ( 66 % ) indicated that the guideline was relevant to their practice . Approval of the draft guideline was strong among these 90 practitioners : 91 % agreed or strongly agreed that the summary of the evidence was acceptable , 87 % agreed with the draft recommendations , and 81 % approved of the recommendations as a practice guideline . Thirty-nine respondents provided written comments ; these comments were , like the other responses , incorporated in the final guideline . Results Sixty-six reports met the criteria for inclusion and are categorized in Table 1 . In each section below , we describe the studies , summarize results , and describe the guideline development . Table 1 . Evidence Included in This Practice Guideline Report What Is Optimal St and ard-Dose Chemotherapy for Patients with Multiple Myeloma ? To properly compare transplantation with conventional chemotherapy , we must define optimal conventional chemotherapy . We identified 30 r and omized trials comparing therapies in previously untreated patients . Four meta-analyses ( 6 - 9 ) evaluated these data . The Myeloma Trialists ' Collaborative Group ( 7 ) compared combination chemotherapy with melphalan plus prednisone in a meta- analysis of 27 trials . Twenty of these trials supplied individual-patient data . No difference in survival was detected . The proportional reduction in the annual odds of death was 1.5 % in favor of combination chemotherapy ( 95 % CI , 8 % to 5 % ; P > 0.2 ) , with an odds ratio ( OR ) of 0.99 ( CI , 0.93 to 1.05 ) . An earlier literature -based meta- analysis ( 6 ) of 18 trials also failed to detect a survival difference between groups ( OR , 1.04 [ CI , 0.90 to 1.19 ] ; P > 0.2 ) . Two meta-analyses evaluated interferon for multiple myeloma . An overview of 24 r and omized trials published in abstract form ( 8) demonstrated that interferon improved recurrence-free survival by 6 months and improved 3-year overall survival by 4 % . Another meta- analysis ( 9 ) measured survival by a unique measure called the mean lifetime survival . This meta- analysis found no difference in survival rate between the group receiving interferon and the group not receiving interferon ( 3.9 vs. 3.4 years , respectively ; P = 0.095 ) . Guideline Recommendation Multiagent chemotherapy or melphalan plus prednisone is appropriate therapy for a control group in a comparison of transplantation versus st and ard-dose therapy . The addition of interferon is unlikely to influence outcomes in the control group . In Terms of Survival , Is Autologous Peripheral Blood Stem-Cell or Bone Marrow Transplantation Better than Conventional Chemotherapy ? We review ed two r and omized and three nonr and omized comparisons ( Table 2 ) . Attal and colleagues ( 3 ) r and omly assigned 200 previously untreated patients younger than 65 years of age with stage II or III ( 40 ) myeloma to conventional chemotherapy or to a strategy that included autologous bone marrow transplantation . Patients were r and omly
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"High-dose therapy has become a common treatment for myeloma . The objectives of this study were to estimate in a prospect i ve , population -based setting the impact on survival of high-dose therapy in newly diagnosed , symptomatic patients less than 60 years old and to compare the results with those of conventionally treated historic controls . The prospect i ve population comprised 348 patients . Of these , 274 were treated according to a specified intensive-therapy protocol ( Nordic Myeloma Study Group [ NMSG ] # 5/94 ) and constituted the intensive-therapy group . The historic population consisted of 313 patients identified from 5 previous population -based Nordic studies . Of these , 274 fulfilled the eligibility criteria for high-dose therapy stated in NMSG # 5/94 and constituted the control group . The expected numbers of patients in the prospect i ve population and the historic population were 450 and 410 , respectively , estimated from previously established data on the incidence in this population and the population base for each study . Survival was prolonged in the intensive-therapy group compared with the control group ( risk ratio for the control group 1.62 ; 95 % confidence interval 1.22 - 2.15 ; P = .001 ) . These groups represented more than 60 % of the expected number of patients . When survival for all the registered patients in the 2 population s was compared , representing more than 75 % of the expected number of patients , the advantage for the prospect i ve population persisted ( risk ratio for the historic population 1.46 ; 95 % confidence interval 1.14 - 1.86 ; P = . 002 ) . These results indicate that the introduction of high-dose therapy for newly diagnosed myeloma has result ed in prolonged survival for the total patient population aged less than 60 years . ( Blood . 2000 ; 95:7 - 11",
"Peripheral blood stem cells ( PBCs ) have recently been used to reconstitute hemopoiesis after myeloablative therapy [ 1 , 2 ] . The cells can be collected in patients who are in steady state , but several leukaphereses are needed [ 3 ] . Mobilization of progenitor cells from the bone marrow to the peripheral blood can be achieved with chemotherapy , alone or in combination with hemopoietic growth factors [ 4 - 6 ] , or with hemopoietic growth factors alone administered to patients in hematologic steady state [ 7 - 12 ] . Most studies have shown that the duration of granulocytopenia after autograft is shorter if PBC transplantation is used instead of bone marrow transplantation [ 13 , 14 ] . In 1992 , Sheridan and associates [ 12 ] found a significant reduction in the duration of thrombocytopenia after PBC and bone marrow transplantation compared with bone marrow transplantation alone . However , their study was not prospect i ve and did not include a group that received PBC transplantation alone . Moreover , preliminary reports [ 15 - 17 ] suggest that autologous PBC transplantation is less costly than bone marrow transplantation . Given these encouraging findings , in 1993 the French Federation of Cancer Centers began a r and omized , controlled trial in patients who were receiving high-dose chemotherapy for a solid tumor or lymphoma . The trial compared PBC transplantation with bone marrow transplantation with respect to hematologic recovery and costs . The results of this trial are presented here . Methods Patients Persons of any age and sex who had a solid tumor or lymphoma and were c and i date s for a first course of high-dose chemotherapy and autologous hematopoietic progenitor cell transplantation were eligible for inclusion . No grafts were collected from patients whose condition was newly diagnosed . Patients with a contraindication to cytapheresis or filgrastim , patients with a severe invasive infection , and patients who required an ex vivo purged autograft were ineligible . Written informed consent was required from all eligible adults and from the parents of eligible children . This protocol was approved by the Kremlin-Bicetre ethical committee , France . Interventions When a graft was planned for an eligible patient , the attending physician contacted the trial 's data manager by telephone . The manager used a computer software program to r and omly assign the eligible patient to receive either a PBC graft mobilized by filgrastim or a bone marrow graft . R and omization was stratified by center and , because of the particular hematotoxicity of busulfan and total-body irradiation , by the type of programmed conditioning regimen ( total-body irradiation and high-dose chemotherapy with or without busulfan ) . Stem cells were collected within 1 month after r and omization . Collection of Peripheral Blood Stem Cells and Bone Marrow The initial protocol included bone marrow harvest for rescue for all patients in the PBC group . However , because rescue was not used for the first 30 patients in this group , it was decided that bone marrow be harvested for rescue only when the product of leukapheresis was insufficient . Patients had to be in hematologic steady state before mobilization . Mobilization was done with 10 g of filgrastim per kg of body weight per day , administered subcutaneously over 6 consecutive days . The PBC grafts were collected by three cytaphereses done on days 5 , 6 , and 7 of filgrastim administration . The minimum hemoglobin level required before collection was 10 g/L in adults and 12 g/L in children . Three cell separators were used in the different centers : Spectra ( Cobe Laboratories , Lakewood , Colorado ) , CS 3000 ( Baxter Health Care Corp. , Deerfield , Michigan ) , or AS104 ( Fresenius AG , Bad Homburg , Germany ) . Given the wide variations between laboratories , collection of colony-forming unit granulocyte macrophages ( CFU-GM ) was classified as rich or poor or normal . In the main laboratory , the PBC graft was considered rich if it contained more than 30 104 CFU-GM/kg ; this threshold was adapted for use in the other laboratories . Bone marrow was collected from the iliac crests while patients were under general anesthesia , as described elsewhere [ 18 ] . The graft was considered rich if it contained more than 15 104 CFU-GM/kg . Conditioning Regimen and Transplantation The conditioning regimen consisted of high-dose chemotherapy with or without total-body irradiation , in accordance with current protocol s developed by national tumor committees for each type of cancer ( Table 1 ) . Transplantation was to be done 1 to 2 days after the end of the conditioning regimen . Table 1 . Principal Conditioning Regimens according to Diagnosis Filgrastim ( 5 micro g/kg per day ) was administered intravenously to all patients in both groups from day 1 after transplantation until granulocyte recovery ( to a granulocyte count > 1 109/L ) ( controlled twice at 48-hour intervals ) . Use of all other hemopoietic growth factors was prohibited throughout the trial . Data on the side effects of filgrastim were collected . Follow-up Daily surveillance began on the first day of hospitalization for high-dose chemotherapy and was continued throughout the hospital stay . All patients received right atrial catheters on admission and were isolated in laminar air-flow single rooms . They received parenteral nutrition and broad-spectrum antibiotics when indicated . Platelet infusions and erythrocyte concentrates were used to maintain a platelet count greater than 20 109/L and a hemoglobin level greater than 70 g/L. All blood products were irradiated with a dose of 25 Gy before transfusion . All extra hematologic complications were recorded [ 19 ] . After discharge , patients were checked monthly during the first 3 months and once every 3 months thereafter . Outcome Measures Clinical End Points The main clinical outcome measure was the duration of thrombocytopenia ( platelet count time between transplantation and the last platelet transfusion , the duration of thrombocytopenia ( platelet count ) , the duration of granulocytopenia ( granulocyte count , the number of febrile episodes ( a febrile episode was defined as a 12-hour period during which the body temperature was > 38 C ) , the duration of febrile granulocytopenia , and the duration of hospitalization . Costs Direct medical costs were estimated by measuring the physical quantities of capital and labor consumed by each patient . Monetary values were assigned to these quantities on the basis of average 1995 prices in French francs [ 20 ] . Costs were estimated from the date on which patients were admitted to the transplantation unit until discharge and were based on patients ' medical records . These costs included the room cost , the cost of filgrastim after transplantation , the cost of collection ( including the costs of filgrastim priming and cell cryopreservation ) , and other treatment-related costs ( such as those for drugs , laboratory tests , and transfusions ) . Given the inherent differences between hospital charges and real costs ( especially in the context of a publicly funded health care system , such as that in France ) , hospital charges were not used to assess room costs associated with stays in the transplantation unit . Two per diem real costs were calculated on the basis of the Institut Paoli Calmettes transplantation unit ( for adults ) and the Institut Gustave Roussy pediatric transplantation unit ( for children ) . The annual expenditure for consumable supplies , cost for personnel in the unit , and depreciation of equipment were evaluated to calculate these per diem costs for each stay in the transplantation unit . The step-down method was used to add overhead costs to these per diem costs [ 21 , 22 ] . An additional study was done on the basis of detailed observations made during 42 leukapheresis procedures and 141 bone marrow harvest procedures done between January 1992 and May 1993 at the Institut Paoli Calmettes to determine the average cost of the two collection procedures . These average costs were ultimately applied to the study patients . Statistical Analysis It was estimated [ 23 ] that at least 70 patients per group would be needed to show a minimal reduction of 10 days in the duration of thrombocytopenia in the PBC group ( one-tailed test , = 0.05 , = 0.10 ; duration of thrombocytopenia in the bone marrow group SD , 33 20 days ) . Analyses were done using the intention-to-treat principle . Differences between groups were evaluated by the chi-square test or the Fisher exact test for categorical variables and by the Student t-test or nonparametric test for continuous variables ( two-sided tests ) . All analyses of clinical end points were adjusted for center and type of conditioning regimen . In the life-table analysis , actuarial probabilities were estimated using the Kaplan-Meier method [ 24 ] . The curves carry 95 % CIs calculated according to the method of Rothman [ 25 ] . Survival curves were compared using the log-rank test [ 26 ] . Values are the mean SD unless otherwise indicated . Industry Support Laboratoire AMGEN ( Neuilly , France ) provided support for this study with an agreement that the report would be su bmi tted for publication regardless of the findings . One of the authors participated in developing the protocol s and is a Laboratoire AMGEN employee . Results A total of 148 patients were r and omly assigned to treatment in nine transplantation units between April 1993 and December 1994 . Fourteen patients ( 7 in each group ) had relapse after r and omization and were no longer eligible for high-dose chemotherapy , 2 patients ( both in the PBC group ) refused treatment , and collection could not be done in 3 patients ( 1 in the PBC group and 2 in the bone marrow group ) . Thus , the analysis presented here includes the 129 patients who received high-dose chemotherapy ( 64 in the PBC group and 65 in the bone marrow group ) . Table 2 shows the baseline characteristics of the two groups . High-dose chemotherapy was",
"Virtually no progress has been made during more than 2 decades of clinical trials for multiple myeloma ( MM ) involving st and ard therapy ( ST ) . Recent studies suggest that dose intensification requiring hematopoietic stem cell support results in higher complete response ( CR ) rates and extended disease control . \" Total Therapy \" ( TT ) consisting of noncross-resistant induction regimens , followed by a double autotransplant ( AT ) procedure , was administered to 123 untreated patients with symptomatic MM . Upon hematologic recovery , interferon ( IFN ) maintenance ( 3 million units [MU]/m2 subcutaneously thrice weekly ) was given until disease recurrence/progression . Results were compared with the outcome of untreated patients receiving ST according to Southwest Oncology Group ( SWOG ) trials . One hundred sixteen pair mates were selected from both TT and among 1,123 patients to match for the major prognostic features . TT induced CR in 40 % of all 123 patients ( intent-to-treat ) . By 12 months , 7 % had died , including 4 % from treatment-related complications . With a median follow-up of 31 months , median duration s of event-free survival ( EFS ) and overall survival ( OS ) are 49 and 62 + months , respectively . Abnormalities of chromosomes 11q and 13 were associated with inferior outcome , whereas CR within 6 months after induction was a favorable prognostic feature for both EFS and OS . In comparison to ST , TT induced higher PR rates ( 85 % v 52 % , P EFS ( 49 v 22 months , P = .0001 ) and OS ( 62 + v 48 months , P = .01 ) . Compared to ST , dose intensification with double AT markedly augments tumor cytoreduction , effecting not only higher CR rates but also significantly extending EFS and OS in previously untreated patients with MM",
"Results to date indicate that high-dose therapy ( HDT ) with autologous stem cell support improves survival of patients with symptomatic multiple myeloma ( MM ) . We performed a multicenter , sequential , r and omized trial design ed to assess the optimal timing of HDT and autotransplantation . Among 202 enrolled patients who were up to 56 years old , 185 were r and omly assigned to receive HDT and peripheral blood stem cell ( PBSC ) autotransplantation ( early HDT group , n = 91 ) or a conventional-dose chemotherapy ( CCT ) regimen ( late HDT group , n = 94 ) . In the late HDT group , HDT and transplantation were performed as rescue treament , in case of primary resistance to CCT or at relapse in responders . PBSC were collected before r and omization , after mobilization by chemotherapy , and , in the two groups , HDT was preceded by three or four treatments with vincristine , doxorubicin , and methylprednisolone . Data were analyzed on an intent-to-treat basis using a sequential design . Within a median follow-up of 58 months , estimated median overall survival ( OS ) was 64.6 months in the early HDT group and 64 months in the late group . Survival curves were not different ( P = .92 , log-rank test ) . Median event-free survival ( EFS ) was 39 months in the early HDT group whereas median time between r and omization and CCT failure was 13 months in the late group . Average time without symptoms , treatment , and treatment toxicity ( TWiSTT ) were 27.8 months ( 95 % confidence interval [ CI ] ; range , 23.8 to 31.8 ) and 22.3 months ( range , 16.0 to 28.6 ) in the two groups , respectively . HDT with PBSC transplantation obtained a median OS exceeding 5 years in young patients with symptomatic MM , whether performed early , as first-line therapy , or late , as rescue treatment . Early HDT may be preferred because it is associated with a shorter period of chemotherapy",
"We performed a multicenter comparative analysis of autologous peripheral blood stem cell transplantation ( PBSCT ) and allogeneic bone marrow transplantation ( alloBMT ) in multiple myeloma . Forty-eight consecutive patients received either PBSCT ( 24 patients ) or alloBMT ( 24 patients ) at one of three institutions in the study group . Preparatory regimens consisted of melphalan and total body irradiation ( TBI ) or melphalan alone in the PBSCT group . The alloBMT group received one of four regimens : cyclophosphamide and TBI ; cyclophosphamide , VP-16 and 1,3-bis(2-chloroethyl)-1-nitrosourea ( CVB ) ; busulfan and cyclophosphamide ( BU/CY ) and total marrow irradiation ( TMI ) ; or melphalan and TBI . Procedure-related mortality was 12.5 % for the PBSCT group and 25 % for the alloBMT group . With a median follow-up for survivors in the PBSCT and alloBMT groups of 11 months ( range , 4 - 46 ) and 15 months ( range , 2 - 84 months ) , respectively , there was no significant difference in median overall survival ( 33.5 versus 38.6 months , p = 0.7637 ) or event-free survival ( 16.7 versus 31 months , p = 0.8450 ) . There was , however , a plateau in survival at 40 % in the alloBMT group . No plateau in survival was seen in the PBSCT group . Clinical relapses occurred as late as 39 months posttransplant . Patients have survived up to 28 months postrelapse",
"BACKGROUND The median survival of patients with myeloma after conventional chemotherapy is three years or less . Promising results have been reported with high-dose therapy supported by autologous bone marrow transplantation . We conducted a r and omized study comparing conventional chemotherapy and high-dose therapy . METHODS Two hundred previously untreated patients under the age of 65 years who had myeloma were r and omly assigned at the time of diagnosis to receive either conventional chemotherapy or high-dose therapy and autologous bone marrow transplantation . RESULTS The response rate among the patients who received high-dose therapy was 81 percent ( including complete responses in 22 percent and very good partial responses in 16 percent ) , whereas it was 57 percent ( complete responses in 5 percent and very good partial responses in 9 percent ) in the group treated with conventional chemotherapy ( P probability of event-free survival for five years was 28 percent in the high-dose group and 10 percent in the conventional-dose group ( P = 0.01 ) ; the overall estimated rate of survival for five years was 52 percent in the high-dose group and 12 percent in the conventional-dose group ( P = 0.03 ) . Treatment-related mortality was similar in the two groups . CONCLUSIONS High-dose therapy combined with transplantation improves the response rate , eventfree survival , and overall survival in patients with myeloma",
"Interferon ( INF ) has been incorporated as part of maintenance therapy after high dose treatment in order to make remissions more durable . In this study we have compared peripheral blood stem cell transplant ( PBSCT ) versus autologous bone marrow transplant ( ABMT ) with respect to INF tolerance . Thirty nine PBSCT patients have been compared to 37 ABMT patients for INF tolerance . This is followed by a comparison of 15 PBSCT patients versus 21 ABMT patients for engraftment details , response and survival . INF was started at a median of 61 days in the PBSCT and 58 days in the ABMT patients ( P = NS ) . It was well tolerated in both groups without a significant difference in toxicity in the two arms . Engraftment was more rapid in the PBSCT patients with platelet recovery being significantly faster . Response and survival showed a favourable trend for ABMT patients though statistical significance was not reached and the cost of PBSCT was 12 % cheaper . We were thus able to conclude that PBSCT grafts were as durable and could tolerate INF just as well as ABMT . Engraftment was more rapid and the procedure of PBSCT was also cheaper . Further studies with a larger group of patients will be required before comments on the efficacy of treatment can be made",
"High‐dose chemotherapy ( melphalan ) with autologous marrow stem cell support ( AMSCS ) results in high response rates in multiple myeloma ( MM ) , with up to 50 % of patients achieving complete remission . However , these remissions are generally not durable . As the cytokine interferon alpha has been shown to prolong partial response following conventional chemotherapy , this trial was conducted to evaluate its role following high‐dose chemotherapy . 85 patients were r and omly assigned to maintenance treatment with interferon alpha , 3 × 106 units/m2 subcutaneously three times weekly until relapse or no further treatment following recovery from high‐dose chemotherapy ( melphalan 140–200 mg/m2 or busulphan 16 mg/kg ) combined with AMSCS . At 5.8 years following the accrual of the last patient in this trial , 38 patients had died , 17 in the interferon arm and 21 in the control arm . The median progression‐free survival ( PFS ) in the 42 patients r and omized to interferon alpha was 46 months versus 27 months in the controls . Both overall survival and PFS , which were highly significant at median follow‐up of 52 months , have now ceased to be significant , because most patients have ultimately succumbed to their disease . Interferon was tolerated by the majority of patients with very good compliance . Toxicity consisted mainly of flu‐like symptoms and malaise which were usually self‐limiting . The results of such a pilot study should be carefully interpreted and the benefits of interferon should be confirmed in larger multi‐centre studies in the setting of minimal residual disease following autologous transplantation"
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41172e90-06ff-11f0-808a-c43d1ab1c353
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Background Disability in Activities of Daily Living ( ADL ) is an adverse outcome of frailty that places a burden on frail elderly people , care providers and the care system . Knowing which physical frailty indicators predict ADL disability is useful in identifying elderly people who might benefit from an intervention that prevents disability or increases functioning in daily life . The objective of this study was to systematic ally review the literature on the predictive value of physical frailty indicators on ADL disability in community-dwelling elderly people . Methods A systematic search was performed in 3 data bases ( PubMed , CINAHL , EMBASE ) from January 1975 until April 2010 . Prospect i ve , longitudinal studies that assessed the predictive value of individual physical frailty indicators on ADL disability in community-dwelling elderly people aged 65 years and older were eligible for inclusion . Articles were review ed by two independent review ers who also assessed the quality of the included studies . Results After initial screening of 3081 titles , 360 abstract s were scrutinized , leaving 64 full text articles for final review . Eventually , 28 studies were included in the review . The method ological quality of these studies was rated by both review ers on a scale from 0 to 27 . All included studies were of high quality with a mean quality score of 22.5 ( SD 1.6 ) . Findings indicated that individual physical frailty indicators , such as weight loss , gait speed , grip strength , physical activity , balance , and lower extremity function are predictors of future ADL disability in community-dwelling elderly people . Conclusions This review shows that physical frailty indicators can predict ADL disability in community-dwelling elderly people . Slow gait speed and low physical activity/exercise seem to be the most powerful predictors followed by weight loss , lower extremity function , balance , muscle strength , and other indicators . These findings should be interpreted with caution because the data of the different studies could not be pooled due to large variations in operationalization of the indicators and ADL disability across the included studies . Nevertheless , our study suggests that monitoring physical frailty indicators in community-dwelling elderly people might be useful to identify elderly people who could benefit from disability prevention programs
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"Background and aims : Little is known about muscle strength as a predictor of disability among older Mexican Americans . The aim of this study was to examine the association between h and grip strength and 7-year incidence of ADL disability in older Mexican American men and women . Methods : A 7-year prospect i ve cohort study of 2493 non-institutionalized Mexican American men and women aged 65 or older residing in five south-western states . Maximal h and grip strength test , body mass index , cognitive function , activities of daily living , self-reports of medical conditions ( arthritis , diabetes , heart attack , stroke , cancer , hip fracture ) , and depressive symptoms were obtained . Results : In a Cox proportional regression analysis , there was a linear relationship between h and grip strength at baseline and risk of incident ADL disability over a 7-year follow-up . Among non-disabled men at baseline , the hazard ratio of any new ADL limitation was 1.90(95 % CI 1.14–3.17 ) for those in the lowest quartile , when compared with men in the highest h and grip strength quartile , after controlling for age , marital status , medical conditions , high depressive symptoms , MMSE score , and BMI at baseline . Among non-disabled women at baseline , the hazard ratio of any new ADL limitation was 2.28 ( 95 % CI 1.59–3.27 ) for those in the lowest quartile , when compared with women in the highest h and grip strength quartile . Conclusions : H and grip strength is an independent predictor of ADL disability among older Mexican American men and women . The h and grip strength test is an easy , reliable , valid , inexpensive method of screening to identify older adults at risk of disability",
"OBJECTIVES To determine the independent prognostic effect of seven potential frailty criteria , including five from the Fried phenotype , on several adverse outcomes . DESIGN Prospect i ve cohort study . SETTING Greater New Haven , Connecticut . PARTICIPANTS Seven hundred fifty-four initially nondisabled , community-living persons aged 70 and older . MEASUREMENTS An assessment of seven potential frailty criteria ( slow gait speed , low physical activity , weight loss , exhaustion , weakness , cognitive impairment , and depressive symptoms ) was completed at baseline and every 18 months for 72 months . Participants were followed with monthly telephone interviews for up to 96 months to determine the occurrence of chronic disability , long-term nursing home ( NH ) stays , injurious falls , and death . RESULTS In analyses adjusted for age , sex , race , education , number of chronic conditions , and the presence of the other potential frailty criteria , three of the five Fried criteria ( slow gait speed , low physical activity , and weight loss ) were independently associated with chronic disability , long-term NH stays , and death . Slow gait speed was the strongest predictor of chronic disability ( hazard ratio (HR)=2.97 , 95 % confidence interval (CI)=2.32 - 3.80 ) and long-term NH stay ( HR=3.86 , 95 % CI=2.23 - 6.67 ) and was the only significant predictor of injurious falls ( HR=2.19 , 95 % CI=1.33 - 3.60 ) . Cognitive impairment was also associated with chronic disability ( HR=1.82 , 95 % CI=1.40 - 2.38 ) , long-term NH stay ( HR=2.64 , 95 % CI=1.75 - 3.99 ) , and death ( HR=1.54 , 95 % CI=1.13 - 2.10 ) , and the magnitude of these associations was comparable with that of weight loss . CONCLUSION The results of this study provide strong evidence to support the use of slow gait speed , low physical activity , weight loss , and cognitive impairment as key indicators of frailty while raising concerns about the value of self-reported exhaustion and muscle weakness",
"OBJECTIVE To identify modifiable predictors of functional decline among community-residing older women and to derive and vali date a clinical prediction tool for functional decline based only on modifiable predictors . DESIGN A prospect i ve cohort study . SETTING Four geographic areas of the United States . PARTICIPANTS Community-residing women older than age 65 recruited from population -based listings between 1986 and 1988 ( n = 6632 ) . MEASUREMENTS Modifiable predictors were considered to be those that a clinician seeing an older patient for the first time could reasonably expect to change over a 4-year period : benzodiazepine use , depression , low exercise level , low social functioning , body-mass index , poor visual acuity , low bone mineral density , slow gait , and weak grip . Known predictors of functional decline unlikely to be amenable to intervention included age , education , medical comorbidity , cognitive function , smoking history , and presence of previous spine fracture . All variables were measured at baseline ; only modifiable predictors were c and i date s for the prediction tool . Functional decline was defined as loss of ability over the 4-year interval to perform one or more of five vigorous or eight basic daily activities . RESULTS Slow gait , short-acting benzodiazepine use , depression , low exercise level , and obesity were significant modifiable predictors of functional decline in both vigorous and basic activities . Weak grip predicted functional decline in vigorous activities , whereas long-acting benzodiazepine use and poor visual acuity predicted functional decline in basic activities . A prediction rule based on these eight modifiable predictors classified women in the derivation set into three risk groups for decline in vigorous activities ( 12 % , 25 % , and 39 % risk ) and two risk groups for decline in basic activities ( 2 % and 10 % risk ) . In the validation set , the probabilities of functional decline were nearly identical . CONCLUSIONS A substantial portion of the variation of functional decline can be attributed to risk factors amenable to intervention over the short term . Using eight modifiable predictors that can be identified in a single office visit , clinicians can identify older women at risk for functional decline",
"OBJECTIVE To examine the association between frailty status and incidence of disability among non-disabled older Mexican Americans . DESIGN A 10-year prospect i ve cohort study . SUBJECTS A total of 1645 non-institutionalized Mexican Americans aged 67 years and older from the Hispanic Established Population for the Epidemiological Study of the Elderly ( H-EPESE ) , who reported no limitation in activities of daily living at baseline . METHODS Frailty was defined as meeting 3 or more of the following components : ( i ) unintentional weight loss of > 2.26 kg ; ( ii ) weakness ( lowest 20 % in h and grip strength ) ; ( iii ) self-reported exhaustion ; ( iv ) slow walking speed ; and ( v ) low physical activity level . Socio-demographic factors , Mini Mental State Examination , medical conditions , body mass index , and self-reported activities of daily living were obtained . RESULTS Of the 1645 non-disabled subjects at baseline , 820 ( 50 % ) were not frail , 749 ( 45.7 % ) were pre-frail , and 71 ( 4.3 % ) were frail . The hazard ratio of activities of daily living disability at 10-year follow-up for pre-frail subjects was 1.32 ( 95 % confidence interval 1.10 - 1.58 ) and 2.42 ( 95 % confidence interval 70 - 3.46 ) for frail subjects compared with not frail subjects . This association remained statistically significant after controlling for potential confounding factors at baseline . CONCLUSION Pre-frail and frail status in older Mexican Americans was associated with an increased risk of activities of daily living disability over a 10-year period among non-disabled subjects",
"BACKGROUND To estimate the associations of weight dynamics with physical functioning and mortality in older adults . METHODS Longitudinal cohort study using prospect ively collected data on weight , physical function , and health status in four U.S. Communities in the Cardiovascular Health Study . Included were 3,278 participants ( 2,013 women and 541 African Americans ) , aged 65 or older at enrollment , who had at least five weight measurements . Weight was measured at annual clinic visits between 1992 and 1999 , and summary measures of mean weight , coefficient of variation , average annual weight change , and episodes of loss and gain ( cycling ) were calculated . Participants were followed from 1999 to 2006 for activities of daily living ( ADL ) difficulty , incident mobility limitations , and mortality . RESULTS Higher mean weight , weight variability , and weight cycling increased the risk of new onset of ADL difficulties and mobility limitations . After adjustment for risk factors , the hazard ratio ( 95 % confidence interval ) for weight cycling for incident ADL impairment was 1.28 ( 1.12 , 1.47 ) , similar to that for several comorbidities in our model , including cancer and diabetes . Lower weight , weight loss , higher variability , and weight cycling were all risk factors for mortality , after adjustment for demographic risk factors , height , self-report health status , and comorbidities . CONCLUSIONS Variations in weight are important indicators of future physical limitations and mortality in the elderly and may reflect difficulties in maintaining homeostasis throughout older ages . Monitoring the weight of an older person for fluctuations or episodes of both loss and gain is an important aspect of geriatric care",
"OBJECTIVES To estimate the incidence of chronic activities of daily living ( ADL ) disability and to analyze the sociodemographic , health status , adverse lifestyle , and leisure-time physical activity predictors for chronic ADL disability . DESIGN We recruited a cohort of community-dwelling older people in Taipei , Taiwan , who were not ADL disabled in August 1993 , and we followed them until August 1996 . SETTING S AND PARTICIPANTS The study subjects were 1321 community-dwelling people aged 65 years or older who were ADL intact at the initial interview in August 1993 . The study sample was a subset of a probability sample ( n = 1583 ) r and omly selected from household registration s in the four districts of the Taipei metropolitan area . MEASUREMENTS Baseline information regarding various factors potentially associated with the development of chronic ADL disability was assessed and collected at the beginning of the study . Study participants were assessed annually for ADL function by a structured home interview using a six-item scale . Participants who were unable to perform independently at least one of the six items -- eating , bathing , dressing , toileting , transfers , and walking inside the house -- for more than 3 months were considered chronically ADL disabled . Cox proportional hazard regression models were utilized to examine the independent effect of the potential predictors on risk of chronic ADL disability . RESULTS During the 3-year study period , 145 ( 11.0 % ) participants developed chronic ADL disability , 58 ( 4.4 % ) participants were lost to follow-up , and 83 ( 6.3 % ) participants died . Multiple hazard regression analysis showed that individuals aged 70 to 79 years or older than age 80 had increased risk of ADL disability ( relative risk : 2.05 ( 95 % confidence interval ( CI ) , 1.35 - 3.11 ) and 3.89 ( 95%CI , 2.33 - 6.50 ) , respectively ) compared with those participants younger than age 70 . Risk of chronic ADL disability was inversely associated with routine exercise ( RR = 0.52 ; 95 % CI , 0.39 - 0.68 ) . CONCLUSIONS Age is the most significant predictor of chronic ADL disability . Lack of routine exercise is also a significant predictor of ADL disability in older adults",
"OBJECTIVE to investigate and compare the predictive values of four physical performance measures for the onset of functional dependence in older Japanese people living at home . DESIGN a population -based prospect i ve cohort study . SETTING Nangai village , Akita Prefecture , Japan . METHODS out of the population aged 65 years and older living in Nangai ( n = 940 ) in 1992 , we measured h and grip-strength , one-leg st and ing , and usual and maximum walking speeds in 736 subjects who were independent in the five basic activities of daily living . Their functional status was assessed each year for the subsequent 6 years . The outcome event was the onset of functional dependence , defined as a new disability in one or more of the five basic activities of daily living , or death of a subject who had shown no disability at the previous follow-up . RESULTS even after controlling for age , sex and a number of chronic conditions , lower scores on each baseline performance measure showed increased risk for the onset of functional dependence . Maximum walking speed was most sensitive in predicting future dependence for those aged 65 - 74 years , while usual walking speed was most sensitive for people aged > or = 75 years . CONCLUSION walking speed was the best physical performance measure for predicting the onset of functional dependence in a Japanese rural older population",
"The aim of this study was to analyse in particular dependence in instrumental daily life activities ( I-ADLs ) and its association with physical impairments and functional limitations in the elderly . The study was based on cross-sectional data on 70-year-olds ( n = 602 ) and longitudinal data on subjects followed up to the age of 76 ( n = 371 ) . Persons dependent in ADL had lower values in maximum walking speed , grip strength , knee extensor strength , stair climbing capacity and in forward reach , compared with those who were independent in ADL . Walking speed in both women and men and sight impairment in men had the greatest influence on dependence in ADL . Possible critical levels for disability in ADL are discussed , as persons who developed dependence between 70 and 76 already had a lower capacity in walking speed and knee extensor strength at age 70 than persons who retained their independence in ADL ",
"PURPOSE To determine how often disability in essential activities of daily living develops insidiously , and to evaluate whether the likelihood of insidious disability differs on the basis of physical frailty . METHODS We conducted a prospect i ve study of 754 nondisabled , community-living persons aged 70 years or older . Participants were categorized according to the presence or absence of physical frailty , which was defined on the basis of gait speed . Participants were subsequently followed with monthly telephone interviews for 3 years to determine the occurrence of disability in bathing , dressing , walking , or transferring , and to ascertain exposure to precipitating events , which included acute hospital admissions and other illnesses , injuries , or problems leading to restricted activity . RESULTS For first episodes of disability , 73 ( 36 % ) of 203 developed insidiously among the 322 participants who were physically frail and 26 ( 18 % ) of 141 developed insidiously among the 432 participants who were not physically frail ( P insidious disability , with an adjusted odds ratio of 2.4 ( 95 % confidence interval : 1.4 to 4.1 ) . The likelihood that an episode of disability was insidious increased progressively , from 29 % of the 344 first episodes to 65 % of the 155 fourth or higher episodes ( P for trend Disability in essential activities of daily living often occurs insidiously , particularly among older persons who are physically frail or who have had prior episodes of disability",
"OBJECTIVES To verify if h and -grip performance in older men is a predictor of disability . DESIGN Population -based prospect i ve study . SETTING A sample from the Italian rural cohorts of the FINE study ( Finl and , Italy , Netherl and s Elderly ) , representative of the general population of elderly men surveyed in 1991 and 1995 . PARTICIPANTS 140 men aged 71 - 91 years who reported no disability in performing activities of daily living ( ADLs ) , instrumental activity of daily living ( IADLs ) and mobility activities at baseline examination and provided information on their functional status at follow-up 4 years later . MEASUREMENTS Disability was defined as needing help in performing ADLs , IADLs and mobility . H and -grip strength was evaluated at baseline by a mechanical dynamometer . RESULTS After adjusting for potential confounding variables , a lower concentration of high-density lipoprotein cholesterol was the only factor predicting disability in men aged 76 years or younger and only reduced h and -grip strength predicted incident disability in men 77 years or older . CONCLUSION Poor h and strength as measured by h and -grip is a predictor of disability in older people . The h and -grip test is an easy and inexpensive screening tool to identify elderly people at risk of disability",
"OBJECTIVES To examine predictors for functional decline in basic activities of daily living ( BADL ) as well as predictors for decline in instrumental activities of daily living ( IADL ) among nondisabled older Japanese people living in a community during a 3-year interval from 1992 to 1995 . DESIGN A prospect i ve cohort study . SETTING A community-based environment . PARTICIPANTS A total of 583 men and women aged 65 to 89 at baseline who were independent in both BADL and IADL . MEASUREMENTS Independent variables regarding various factors potentially associated with functional decline were obtained from an interview survey and medical examinations at baseline . Dependent variables were functional status in BADL and IADL obtained at the time of the 3-year follow-up . RESULTS During the 3-year follow-up , significant predictors for functional decline in BADL and only IADL decline included ( 1 ) age of > or = 75 , ( 2 ) less h and -grip strength , and ( 3 ) a history of hospitalization during the past 1 year . In addition , having poor intellectual activities and having poor social roles were identified as significant predictors for functional decline in only IADL during the 3-year follow-up . Furthermore , not having the habit of taking a walk was identified as a significant predictor of functional decline in BADL during the 3-year interval . CONCLUSION Having a high level h and -grip strength , good intellectual activities , and good social roles are strongly associated with remaining independence in IADL for the nondisabled Japanese persons aged > or = 65",
"OBJECTIVES To compare the validity of a parsimonious frailty index ( components : weight loss , inability to rise from a chair , and poor energy ( Study of Osteoporotic Fractures ( SOF ) index ) ) with that of the more complex Cardiovascular Health Study ( CHS ) index ( components : unintentional weight loss , low grip strength , poor energy , slowness , and low physical activity ) for prediction of adverse outcomes in older men . DESIGN Prospect i ve cohort study . SETTING Six U.S. centers . PARTICIPANTS Three thous and one hundred thirty-two men aged 67 and older . MEASUREMENTS Frailty status categorized as robust , intermediate stage , or frail using the SOF index and criteria similar to those used in CHS index . Falls were reported three times for 1 year . Disability ( > or=1 new impairments in performing instrumental activities of daily living ) ascertained at 1 year . Fractures and deaths ascertained during 3 years of follow-up . Analysis of area under the receiver operating characteristic curve ( AUC ) statistics compared for models containing the SOF index versus those containing the CHS index . RESULTS Greater evidence of frailty as defined by either index was associated with greater risk of adverse outcomes . Frail men had a higher age-adjusted risk of recurrent falls ( odds ratio (OR)=3.0 - 3.6 ) , disability ( OR=5.3 - 7.5 ) , nonspine fracture ( hazard ratio (HR)=2.2 - 2.3 ) , and death ( HR=2.5 - 3.5 ) ( P AUC comparisons revealed no differences between models with the SOF index and models with the CHS index in discriminating falls ( AUC=0.63 , P=.97 ) , disability ( AUC=0.68 , P=.86 ) , nonspine fracture ( AUC=0.63 , P=.90 ) , or death ( AUC=0.71 for model with SOF index and 0.72 for model with CHS index , P=.19 ) . CONCLUSION The simple SOF index predicts risk of falls , disability , fracture , and mortality in men as well as the more-complex CHS index",
"OBJECTIVES To identify factors associated with functional change in an older population and investigate interactions among selected potential risk factors . DESIGN A population -based prospect i ve cohort study . SETTING A r and om sample was selected from the Group Health Cooperative members in the Seattle area from 1994 to 1996 and followed biennially . PARTICIPANTS Two thous and five hundred eighty-one people aged 65 and older , cognitively intact at baseline . MEASUREMENTS Functional status was measured by activities of daily living , instrumental activities of daily living , and performance-based physical function testing . RESULTS The cohort status at the time of these analyses was : deceased , 391 ; withdrawn , 179 ; dementia , 152 ; and on study , 1,873 . The mean follow-up time was 3.4 years . Using linear regressions with Generalized Estimating Equation , selected medical conditions ( diabetes mellitus , hypertension , coronary heart disease , cerebrovascular disease ( CVD ) , osteoporosis , arthritis , and cancer ) , low cognitive function , depression , and smoking were associated with worse functional outcomes . Exercise and moderate alcohol use were associated with better functional outcomes . Over the follow-up period , coronary heart disease , CVD , and depression were associated with increased rates of functional decline . Exercise and moderate alcohol consumption were associated with decreased rates of functional decline . Significant interactions were observed between exercise and coronary heart disease , moderate alcohol use and CVD , and cognition and CVD . CONCLUSIONS Our study has identified not only risk factors associated with functional decline but also the interactions among these factors . These observations , along with other published research , add to the growing underst and ing of the underlying process of functional change and could provide a basis to design effective strategies to delay functional decline",
"OBJECTIVES To identify risk factors for five different subtypes of disability . DESIGN Prospect i ve cohort study . SETTING Greater New Haven , Connecticut . PARTICIPANTS Seven hundred fifty-four community-living residents aged 70 and older and initially nondisabled in four essential activities of daily living ( bathing , dressing , walking , and transferring ) . MEASUREMENTS C and i date risk factors were measured every 18 months for 90 months during comprehensive home-based assessment s. Disability was assessed during monthly telephone interviews for up to 108 months . In participants who were nondisabled at the start of an 18-month interval , incident episodes of five different disability subtypes were determined during the subsequent 18 months : transient , short-term , long-term , recurrent , and unstable . RESULTS The cumulative incidence rates per 100 person-intervals were 9.8 ( 95 % confidence interval (CI)=8.9 - 10.6 ) for transient disability , 3.8 ( 95 % CI=3.3 - 4.3 ) for short-term disability , 7.1 ( 95 % CI=6.4 - 7.8 ) for long-term disability , 4.7 ( 95 % CI=4.1 - 5.3 ) for recurrent disability , and 4.4 ( 95 % CI=3.9 - 5.0 ) for unstable disability . In a multivariate analysis , the Short Physical Performance Battery ( SPPB ) was associated with each of the five disability subtypes , with adjusted hazard ratios ranging from 1.10 for transient disability to 1.35 for long-term disability . The only other factors associated with short-term , long-term , and recurrent disability were stroke , visual impairment , and poor grip strength , respectively . Transient disability and unstable disability shared the same set of risk factors-depressive symptoms , stroke , and poor grip strength-in addition to the SPPB . CONCLUSION These results provide mixed evidence to support the distinct nature of the five disability subtypes",
"Objective : This article examines the association between frequency of going out of the house and health and functional status among older people . Method : A r and omly chosen cohort of ambulatory participants born in 1920 or 1921 from the Jerusalem Longitudinal Study underwent assessment s for health , functional , and psychosocial variables at ages 70 and 77 . Twelve-year mortality data were collected . Results : Women went out daily less than did men . Participants going out daily at age 70 reported significantly fewer new complaints at age 77 of musculoskeletal pain , sleep problems , urinary incontinence , and decline in activities of daily living ( ADLs ) . Logistic regression analysis indicated that not going out daily at age 70 was predictive of subsequent dependence in ADL , poor self-rated health , and urinary incontinence at age 77 . Discussion : Going out daily is beneficial among independent older people , correlating with reduced functional decline and improved health measures"
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Abstract Objective To review the evidence and provide recommendations on antibiotic prophylaxis for gynaecologic procedures . Outcomes Outcomes evaluated include need and effectiveness of antibiotics to prevent infections in gynaecologic procedures . Evidence Medline and The Cochrane Library were search ed for articles published between January 1978 and January 2011 on the topic of antibiotic prophylaxis in gynaecologic procedures . Results were restricted to systematic review s , r and omized control trials/ controlled clinical trials , and observational studies . Search es were up date d on a regular basis and incorporated in the guideline to June 2011 . Grey ( unpublished ) literature was identified through search ing the websites of health technology assessment and health technology assessment -related agencies , clinical practice guideline collection s , clinical trial registries , and national and international medical specialty societies . Values The quality of evidence obtained was rated using the criteria described in the Report of the Canadian Task Force on Preventative Health Care ( Table 1 ) . Benefits , harms , and costs Guideline implementation should result in a reduction of cost and related harm of administering antibiotics when not required and a reduction of infection and related morbidities when antibiotics have demonstrated a proven benefit . Recommendations 1 . All women undergoing an abdominal or vaginal hysterectomy should receive antibiotic prophylaxis . ( I-A ) 2 . All women undergoing laparoscopic hysterectomy or laparoscopically assisted vaginal hysterectomy should receive prophylactic antibiotics . ( III-B ) 3 . The choice of antibiotic for hysterectomy should be a single dose of a first-generation cephalosporin . If patients are allergic to cephalosporin , then clindamycin , erythromycin , or metronidazole should be used . ( I-A ) 4 . Prophylactic antibiotics should be administered 15 to 60 minutes prior to skin incision . No additional doses are recommended . ( I-A ) 5 . If an open abdominal procedure is lengthy ( e.g. , > 3 hours ) , or if the estimated blood loss is > 1500 mL , an additional dose of the prophylactic antibiotic may be given 3 to 4 hours after the initial dose . ( III-C ) 6 . Antibiotic prophylaxis is not recommended for laparoscopic procedures that involve no direct access from the abdominal cavity to the uterine cavity or vagina . ( l-E ) 7 . All women undergoing surgery for pelvic organ prolapse and /or stress urinary incontinence should receive a single dose of firstgeneration cephalosporin . ( III-B ) 8 . Antibiotic prophylaxis is not recommended for hysteroscopic surgery . ( II-2D ) 9 . All women undergoing an induced ( therapeutic ) surgical abortion should receive prophylactic antibiotics to reduce the risk of postabortal infection . ( I-A ) 10 . Prophylactic antibiotics are not suggested to reduce infectious morbidity following surgery for a missed or incomplete abortion . ( I-E ) 11 . Antibiotic prophylaxis is not recommended for insertion of an intrauterine device . ( I-E ) However , health care professionals could consider screening for sexually transmitted infections in high-risk population s. ( III-C ) 12 . There is insufficient evidence to support the use of antibiotic prophylaxis for an endometrial biopsy . ( III-L ) 13 . The best method to prevent infection after hysterosalpingography is unknown . Women with dilated tubes found at the time of hysterosalpingography are at highest risk , and prophylactic antibiotics ( e.g. , doxycycline ) should be given . ( II-3B ) 14 . Antibiotic prophylaxis is not recommended for urodynamic studies in women at low risk , unless the incidence of urinary tract infection post-urodynamics is > 10 % . ( 1-E ) 15 . In patients with morbid obesity ( BMI > 35 kg/m2 ) , doubling the antibiotic dose may be considered . ( III-B ) 16 Administration of antibiotics solely to prevent endocarditis is not recommended for patients who undergo a genitourinary procedure . ( III-E
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"BACKGROUND The purpose of this statement is to up date the recommendations by the American Heart Association ( AHA ) for the prevention of infective endocarditis that were last published in 1997 . METHODS AND RESULTS A writing group was appointed by the AHA for their expertise in prevention and treatment of infective endocarditis , with liaison members representing the American Dental Association , the Infectious Diseases Society of America , and the American Academy of Pediatrics . The writing group review ed input from national and international experts on infective endocarditis . The recommendations in this document reflect analyses of relevant literature regarding procedure-related bacteremia and infective endocarditis , in vitro susceptibility data of the most common microorganisms that cause infective endocarditis , results of prophylactic studies in animal models of experimental endocarditis , and retrospective and prospect i ve studies of prevention of infective endocarditis . MEDLINE data base search es from 1950 to 2006 were done for English- language papers using the following search terms : endocarditis , infective endocarditis , prophylaxis , prevention , antibiotic , antimicrobial , pathogens , organisms , dental , gastrointestinal , genitourinary , streptococcus , enterococcus , staphylococcus , respiratory , dental surgery , pathogenesis , vaccine , immunization , and bacteremia . The reference lists of the identified papers were also search ed . We also search ed the AHA online library . The American College of Cardiology/AHA classification of recommendations and levels of evidence for practice guidelines were used . The paper was subsequently review ed by outside experts not affiliated with the writing group and by the AHA Science Advisory and Coordinating Committee . CONCLUSIONS The major changes in the up date d recommendations include the following : ( 1 ) The Committee concluded that only an extremely small number of cases of infective endocarditis might be prevented by antibiotic prophylaxis for dental procedures even if such prophylactic therapy were 100 % effective . ( 2 ) Infective endocarditis prophylaxis for dental procedures is reasonable only for patients with underlying cardiac conditions associated with the highest risk of adverse outcome from infective endocarditis . ( 3 ) For patients with these underlying cardiac conditions , prophylaxis is reasonable for all dental procedures that involve manipulation of gingival tissue or the periapical region of teeth or perforation of the oral mucosa . ( 4 ) Prophylaxis is not recommended based solely on an increased lifetime risk of acquisition of infective endocarditis . ( 5 ) Administration of antibiotics solely to prevent endocarditis is not recommended for patients who undergo a genitourinary or gastrointestinal tract procedure . These changes are intended to define more clearly when infective endocarditis prophylaxis is or is not recommended and to provide more uniform and consistent global recommendations",
"Two consecutive open studies were performed of the efficacy of a prophylactic cefuroxime/metronidazole combination in abdominal hysterectomy . The first group received a 24-h regimen , the second group a single pre-operative dose . The incidence of post-operative wound infections and urinary tract infections were similar in both groups [ wound infections in 1/75 versus 2/84 patients ( NS ) , urinary tract infections 4/75 versus 3/84 patients ( NS ) , respectively , in the 24-h group and single-dose group ] . No significant differences in other parameters , such as pyrexia and duration of post-operative hospitalization , could be detected",
"OBJECTIVE The purpose of this study was to determine if antibiotic prophylaxis with nitrofurantoin monohydrate macrocrystals ( study drug ) after pelvic organ prolapse and /or urinary incontinence surgery with suprapubic catheterization ( SPC ) decreases urinary tract infection ( uti ) compared with placebo in a r and omized , double-blind , multicenter trial . STUDY DESIGN Six centers participated in this study . After a negative preoperative urine culture , history , surgical and postoperative course , urine culture and symptoms at SPC removal , and at 6 to 8 weeks postoperative , any other UTI and adherence were recorded . To demonstrate a 50 % decrease in the bacteruria rate from 20 % , with 80 % power and alpha of 0.05 , 438 patients were required . Data were evaluated with Student t test and Fisher exact test . RESULTS Of 449 patients enrolled , 211 r and omized to study drug , and 224 r and omized to placebo . No pre- or perioperative differences existed between groups ( all P>.05 ) . Antibiotic prophylaxis decreased positive urine cultures compared with placebo ( 46 % vs 61 % , P=.002 ) , symptomatic UTI at SPC removal ( 7.2 % vs 19.8 % , P=.001 ) , and any other symptomatic UTI 6 to 8 weeks postoperatively ( 18.9 % vs 32.6 % , P=.002 ) . Antibiotic prophylaxis did not decrease symptomatic UTI at the 6- to 8-week postoperative visit ( 1.8 % vs 5.4 % , P=.10 ) . CONCLUSION Antibiotic prophylaxis with nitrofurantoin monohydrate macrocrystals decreases UTI compared with placebo after pelvic organ prolapse and /or urinary incontinence surgery with suprapubic catheterization",
"BACKGROUND A history ( or lack thereof ) of penicillin allergy is known to be unreliable in predicting reactions on subsequent administration of the drug . This study tests the usefulness of four penicillin allergen skin tests in the prediction of IgE-mediated reactions subsequent to administration of penicillin . METHODS Eight centers cooperated in the National Institute of Allergy and Infectious Diseases trial of the predictive value of skin testing with major and minor penicillin derivatives . Hospitalized adults were tested with a major determinant ( octa-benzylpenicilloyl-ocytalysine ) and a minor determinant mixture and its components ( potassium benzylpenicillin , benzylpenicilloate , and benzylpenicilloyl-N-propylamine ) . Patients then received a therapeutic course of penicillin and were observed , for 48 hours , for adverse reactions compatible with an IgE-mediated immediate or accelerated allergy . RESULTS Among 726 history-positive patients , 566 with negative skin tests received penicillin and only seven ( 1.2 % ) had possibly IgE-mediated reactions . Among 600 history-negative patients , 568 with negative skin tests received penicillin and none had a reaction . Only nine of the 167 positive skin test reactors received a penicillin agent and then usually by cautious incremental dosing . Two ( 22 % ) of these nine patients had reactions compatible with IgE-mediated immediate or accelerated penicillin allergy ; both were positive to the two determinants . CONCLUSIONS These data corroborate previous data about the negative predictive value of negative skin tests to these material s. The reaction rate in skin test-positive patients was significantly higher than in those with negative skin tests , demonstrating the positive predictive value of positive tests to both major and minor determinants . The number of patients positive only to the major determinant or only to the minor determinant mix was too small to draw conclusions about the positive predictive value of either reagent alone",
"A r and omized double-blind prospect i ve study on the efficacy of single-dose antibiotic prophylaxis compared cefuroxime versus metronidazole versus the combination of both agents in vaginal hysterectomy . Overall antibiotic prophylaxis was effective in abscess prevention ( one abscess in 68 patients ) . In the metronidazole group a significantly higher grade of morbidity was observed : febrile morbidity 41 % versus 4 % in the two other groups ; bacteriuria 73 % versus 17 % in the cefuroxime group , versus 13 % in the combined group ; urinary tract infection 23 % , versus 0 % in the two other groups ; post-operative prescription of antibiotics 41 % , versus 0 % in the two other groups . Febrile morbidity and bacteriuria correlated positively withEscherichia coli and Proteus spp . These micro-organisms were recovered significantly more often from the vagina of patients in the metronidazole group . Cefuroxime was successful , metronidazole failed in the prevention of minor morbidity . We could not observe any effect from the addition of metronidazole to the cefuroxime prophylaxis",
"OBJECTIVE : Bacterial vaginosis ( BV ) is a known risk factor for postoperative infection following abdominal hysterectomy . Vaginal bacterial flora scored as intermediate has been shown to have the same risk of postoperative infection as BV . METHODS : Women undergoing total abdominal hysterectomy for benign diseases were open-r and omized according to Zelen to either treatment with metronidazole rectally for at least 4 days or no treatment . At the preoperative gynecological examination a vaginal smear was collected and Gram stained . Women with BV or intermediate flora were merged to one group called abnormal vaginal flora . RESULTS : In total 213 women were r and omized to treatment or no treatment . After exclusion of 71 women , 142 women were eligible for analysis . Among the 59 women diagnosed with abnormal vaginal flora there were no vaginal cuff infections in the treated arm , compared with 27 % in the ' no treatment ' arm ( p vaginal cuff infection rate from 9.5 to 2 % among the 83 women with lactobacilli flora . However , this difference was not statistically significant . Treatment had no effect on the rate of wound infections . Intention-to-treat analysis showed a significant reduction in vaginal cuff infections among women r and omized to treatment . CONCLUSION : Pre- and postoperative treatment for at least 4 days with metronidazole rectally reduces significantly vaginal cuff infection among women with abnormal vaginal flora",
"Objective : The purpose of this study was to investigate the efficacy of 200 mg of prophylactic doxycycline in preventing pelvic infection after curettage for spontaneous ( incomplete ) abortion . Methods : A r and omized , prospect i ve , double-blinded study was carried out involving 300 women with an incomplete abortion who were given either placebo or 200 mg of doxycycline orally 30–60 min prior to curettage . A hematocrit , WBC count , pregnancy test , syphilis serology , Neisseria gonorrhoeae culture , and Micro Trak ( monoclonal antibody test , Syba , San Jose , CA ) for Chlamydia trachomatis were performed . The patients were scheduled for follow-up 2 weeks later . Antibiotic administration for any reason as well as the postoperative infection rate in these women was assessed . Results : Eleven women were excluded from analysis , leaving 289 evaluable . N. gonorrhoeae was isolated from 6 ( 2 % ) women and C. trachomatis from 8 ( 3 % ) women , and the syphilis serology was serofast in 4 ( 1 % ) women . Endometritis complicated the procedure in 4 women who received placebo and in 1 woman who received doxycycline ( P = 0.22 ) . Conclusion : Prophylactic doxycycline is not effective in preventing pelvic infection after curettage for spontaneous ( incomplete ) abortion",
"Background . Bacterial vaginosis ( BV ) and intermediate flora is known risk‐factor for postoperative infection after surgical termination of pregnancy . Vaginal application of 2 % clindamycin cream is an efficacious treatment for BV , but it is not known whether preoperative administration of clindamycin cream might reduce the signs of post‐abortion infection after surgical termination of pregnancy",
"HYPOTHESIS Surgical site infections ( SSIs ) are a major contributor to patient injury , mortality , and health care costs . Despite evidence of effectiveness of antimicrobials to prevent SSIs , previous studies have demonstrated inappropriate timing , selection , and excess duration of administration of antimicrobial prophylaxis . We herein describe the use of antimicrobial prophylaxis for Medicare patients undergoing major surgery . DESIGN National retrospective cohort study with medical record review . SETTING Two thous and nine hundred sixty-five acute-care US hospitals . PATIENTS A systematic r and om sample of 34,133 Medicare in patients undergoing coronary artery bypass grafting ; other open-chest cardiac surgery ( excluding transplantation ) ; vascular surgery , including aneurysm repair , thromboendarterectomy , and vein bypass operations ; general abdominal colorectal surgery ; hip and knee total joint arthroplasty ( excluding revision surgery ) ; and abdominal and vaginal hysterectomy from January 1 through November 30 , 2001 . MAIN OUTCOME MEASURES The proportion of patients who had parenteral antimicrobial prophylaxis initiated within 1 hour before the surgical incision ; the proportion of patients who were given a prophylactic antimicrobial agent that was consistent with currently published guidelines ; and the proportion of patients whose antimicrobial prophylaxis was discontinued within 24 hours after surgery . RESULTS An antimicrobial dose was administered to 55.7 % ( 95 % confidence interval [ CI ] , 54.8%-56.6 % ) of patients within 1 hour before incision . Antimicrobial agents consistent with published guidelines were administered to 92.6 % ( 95 % CI , 92.3%-92.8 % ) of the patients . Antimicrobial prophylaxis was discontinued within 24 hours of surgery end time for only 40.7 % ( 95 % CI , 40.2%-41.2 % ) of patients . CONCLUSION Substantial opportunities exist to improve the use of prophylactic antimicrobials for patients undergoing major surgery",
"Objective To determine the prevalence of bacterial vaginosis in women undergoing first trimester suction termination of pregnancy and to evaluate the efficacy of metronidazole in reducing the risk of post abortal pelvic infection in women with bacterial vaginosis",
"BACKGROUND Asymptomatic bacteriuria is common in young women , but little is known about its pathogenesis , natural history , risk factors , and temporal association with symptomatic urinary tract infection . METHODS We prospect ively evaluated 796 sexually active , nonpregnant women from 18 through 40 years of age over a period of six months for the occurrence of asymptomatic bacteriuria ( defined as at least 10(5 ) colony-forming units of urinary tract pathogens per milliliter ) . The women were patients at either a university student health center or a health maintenance organization . Periodic urine cultures were taken , daily diaries were kept , and regularly scheduled interviews were performed . Escherichia coli strains were tested for hemolysin , the papG genotype , and the ribosomal RNA type . RESULTS The prevalence of asymptomatic bacteriuria ( the proportion of urine cultures with bacteriuria in asymptomatic women ) was 5 percent ( 95 percent confidence interval , 4 percent to 6 percent ) among women in the university group and 6 percent ( 95 percent confidence interval , 5 percent to 8 percent ) among women in the health-maintenance-organization group . Persistent asymptomatic bacteriuria with the same E. coli strain was rare . Symptomatic urinary tract infection developed within one week after 8 percent of occasions on which a culture showed asymptomatic bacteriuria , as compared with 1 percent of occasions when asymptomatic bacteriuria was not found ( P Asymptomatic bacteriuria was associated with the same risk factors as for symptomatic urinary tract infection , particularly the use of a diaphragm plus spermicide and sexual intercourse . CONCLUSIONS Asymptomatic bacteriuria in young women is common but rarely persists . It is a strong predictor of subsequent symptomatic urinary tract infection",
"Abstract A prospect i ve r and omized study was conducted at the Department of Obstetrics and Gynecology , University of Bari to compare two antimicrobial regimens , amoxicillin-clavulanic acid with cefazolin as ultra-short term prophylaxis in laparotomic gynecologic surgery . Patients were r and omly allocated to receive a single dose of amoxicillin-clavulanic acid ( 2.2 g ) [ Group A ] or cefazolin ( 2 g ) [ Group B ] 30 minutes before surgery . Each patient was assessed daily until discharge for fever and the presence of infection of the surgical wound , urinary tract and respiratory tract . In the amoxicillin-clavulanic acid ( Group A ) and cefazolin ( Group B ) groups , overall 258 and 253 patients , respectively were evaluable for prophylactic efficacy at hospital discharge . Infectious complications were infrequent in both arms . Febrile morbidity occurred in 16 ( 6.3 % ) and 21 ( 8.1 % ) patients respectively in the amoxicillinclavulanic acid and cefazolin groups . Wound infection and urinary tract infection were also higher but not significantly in the cefazolin group ( 0.8 % versus 0 % and 2.7 % versus 2.0 % respectively ) . There was no respiratory tract infection or septic death in either group . It is concluded that ultra-short term prophylaxis with both amoxicillin-clavulanic acid and cefazolin is safe and effective in elective laparotomic gynecologic surgery",
"A prospect i ve double-blind study was performed to evaluate the effect of prophylactic antibiotic treatment before induced abortion . Eight hundred consecutive women admitted for first-trimester abortion , without signs of genital infection or antibiotic use in the last three weeks , were included in the study . Doxycycline 400 mg or placebo was given as a single oral dose ten to 12 hours before vacuum aspiration . Ninety-one women ( 11.8 % ) returned to the hospital with suspected complications . Thirty-two of these women were diagnosed as having pelvic inflammatory disease , eight of whom ( 2.1 % ) had received doxycycline before the abortion and 24 of whom ( 6.2 % ) had received placebo , a statistically significant difference ( P risk of developing it again after an abortion",
"OBJECTIVE To assess the prevalence of infectious complications and the protective effect of prophylactic antibiotic treatment after diagnostic office hysteroscopy in asymptomatic , infertile patients with normal results from transvaginal sonography . DESIGN Recording of infectious complications after routine hysteroscopy in the context of a r and omized controlled trial ; pseudor and omized , center-specific application of antibiotic prophylaxis . SETTING Two tertiary infertility care units . PATIENT(S ) Six hundred thirty-one unselected , asymptomatic , infertile women who underwent routine , diagnostic hysteroscopy prior to a first in vitro fertilization ( IVF ) or intracytoplasmic sperm injection treatment . INTERVENTION(S ) Depending on the hospital and according to local protocol s , hysteroscopy was performed with or without antibiotic prophylaxis . MAIN OUTCOME MEASURE(S ) The prevalence of infectious complications after routine hysteroscopy . RESULT ( S ) Of the 631 women who underwent routine , diagnostic hysteroscopy , antibiotic prophylaxis was prescribed to 266 women , whereas 365 women underwent the procedure without prophylaxis . Only one infectious complication occurred ( 0.4 % ) in a patient who had not undergone therapeutic interventions and had taken antibiotic prophylaxis . This complication was successfully treated with antibiotics on an outpatient basis . CONCLUSION ( S ) Considering the extremely low risk of infectious complications and the lack of evidence , suggesting a beneficial effect of antibiotic prophylaxis , its use for routine , diagnostic office hysteroscopy should not be recommended",
"BACKGROUND R and omized , controlled trials have shown that prophylactic antibiotics are effective in preventing surgical-wound infections . However , it is uncertain how the timing of antibiotic administration affects the risk of surgical-wound infection in actual clinical practice . METHODS We prospect ively monitored the timing of antibiotic prophylaxis and studied the occurrence of surgical-wound infections in 2847 patients undergoing elective clean or \" clean-contaminated \" surgical procedures at a large community hospital . The administration of antibiotics 2 to 24 hours before the surgical incision was defined as early ; that during the 2 hours before the incision , as preoperative ; that during the 3 hours after the incision , as perioperative ; and that more than 3 but less than 24 hours after the incision , as postoperative . RESULTS Of the 1708 patients who received the prophylactic antibiotics preoperatively , 10 ( 0.6 percent ) subsequently had surgical-wound infections . Of the 282 patients who received the antibiotics perioperatively , 4 ( 1.4 percent ) had such infections ( P = 0.12 ; relative risk as compared with the preoperatively treated group , 2.4 ; 95 percent confidence interval , 0.9 to 7.9 ) . Of 488 patients who received the antibiotics postoperatively , 16 ( 3.3 percent ) had wound infections ( P less than 0.0001 ; relative risk , 5.8 ; 95 percent confidence interval , 2.6 to 12.3 ) . Finally , of 369 patients who had antibiotics administered early , 14 ( 3.8 percent ) had wound infections ( P less than 0.0001 ; relative risk , 6.7 ; 95 percent confidence interval , 2.9 to 14.7 ) . Stepwise logistic-regression analysis confirmed that the administration of antibiotics in the preoperative period was associated with the lowest risk of surgical-wound infection . CONCLUSIONS We conclude that in surgical practice there is considerable variation in the timing of prophylactic administration of antibiotics and that administration in the two hours before surgery reduces the risk of wound infection",
"OBJECTIVE To study the effect of prophylactic antibiotics on the incidence of bacteraemia following hysteroscopic surgery . DESIGN Prospect i ve r and omized study . SETTING Aberdeen Royal Infirmary . SUBJECTS One hundred and sixteen women about to undergo either endometrial laser ablation ( ELA ) or transcervical resection of the endometrium ( TCRE ) . INTERVENTION Fifty-five women were r and omised to receive 1.2 g of Augmentin ( co-amoxiclav ) i.v . at induction of anaesthesia . Sixty-one women received no antibiotic prophylaxis . Blood cultures were obtained at the end of the surgical procedure . RESULTS Incidence of bacteraemia in the non-antibiotic group ( 16 % ) was significantly higher than that in the antibiotic group ( 2 % ) ( 95 % confidence interval for difference from 5 % to 25 % ) . The majority of organisms were of dubious clinical significance and contamination could not be excluded in 7 cases out of 10 . CONCLUSION There is no convincing evidence that antibiotics are of value in this clinical setting",
"The prophylactic use of 300 mg doxycycline at the time of an abortion was evaluated in a r and omized controlled trial . In the group with negative chlamydia screening results , only two ( 0.4 % ) of 502 patients who received prophylactic treatment developed pelvic infection , compared with 15 ( 3.0 % ) of 497 patients who received placebos ( p = 0.001 ) . The same effectiveness was found in women with positive chlamydia screening results . Vomiting was the major side effect of the medication and could limit its use . A simulation of selective prophylaxis in women with negative chlamydia screening results showed that its selective use in patients with a history of gonorrhea or in Noneiparous women with multiple sex partners could be nearly two thirds as effective as general prophylaxis",
"In a double-blind controlled trial , the efficacy of prophylactic metronidazole in elective first trimester abortions was assessed . Of 119 r and omized women , 100 followed the protocol . Fifty-one women received 400 mg metronidazole one hour before and again four and eight hours after abortion ; 49 women received a placebo . In the placebo group 20.4 % contracted postabortal genital infection compared with 3.9 % in the metronidazole group ( P 25 women with a positive history of pelvic inflammatory disease , six contracted postabortal infection , which was a significantly increased frequency compared with women without previous episodes of pelvic inflammatory disease ( P frequency . The number of hospital days was not significantly lower in the prophylaxis group ( P>.05 ) . The total amount of metronidazole prescribed in the study group was significantly larger than in the placebo group ( P ampicillin/ pivampicillin prescribed in the placebo group was significantly larger ( P difference between the penicillin doses given in the treatment and placebo groups was not significant ( P>.1 ) . ( Obstet Gynecol 65:371 , 1985",
"To assess the efficacy of a single dose of ampicillin or cefazolin in preventing fever and infection after elective abdominal hysterectomy , we conducted a multicentre , r and omized , double-blind , controlled trial at Srinagarind Hospital , Faculty of Medicine , Khon Kaen University and Khon Kaen Regional Hospital . Three hundred and thirty patients scheduled for elective abdominal hysterectomy were r and omly allocated into either placebo , ampicillin or cefazolin groups . Patients received sterile water ( 3 mL ) or ampicillin ( 1 g ) or cefazolin ( 1 g ) intravenously according to r and om assignment 30 min before the operation . After the operation , all patients were assessed by blinded independent evaluators until discharged from the hospitals . Our main outcome measures were postoperative fever and infectious morbidity . We found that 321 patients ( 97.3 % of recruited patients ) were available for data analysis , 108 in placebo , 106 in ampicillin and 107 in cefazolin group . Febrile morbidity occurred in 13/108 ( 12.0 % ) , 14/106 ( 13.2 % ) and 12/107 ( 11.2 % ) of patients in the placebo , ampicillin and cefazolin groups , respectively . There was no statistically significant difference in febrile morbidity between the three groups . Infectious morbidity was found in 29/108 ( 26.9 % ) , 24/106 ( 22.6 % ) and 11/107 ( 10.3 % ) of patients in the placebo , ampicillin and cefazolin groups , respectively . There was a statistically significant difference between the placebo and cefazolin groups ( P = 0.002 ) . Between the placebo and ampicillin groups , the result was not significantly different ( P = 0.476 ) . There was a statistically significant difference between the cefazolin and ampicillin groups ( P = 0.015 ) . The common causes of infectious morbidity were urinary tract infection , vaginal cuff infection and surgical wound infection . We concluded that antibiotic prophylaxis by cefazolin should be recommended for elective total abdominal hysterectomy",
"Objective To determine whether prophylactic doxycycline at suction curettage for incomplete abortion decreases the rate of postoperative pelvic infection . Methods We r and omized 240 patients to receive intravenous doxycycline or placebo at curettage . Cervical specimens for gonorrhea and chlamydia were obtained preoperatively . Two weeks post-procedure , we evaluated all patients for infectious morbidity and repeated gonorrhea and chlamydia cultures . Statistical analysis used Mann-Whitney U test , McNemar test , or Fisher exact test , as appropriate . Results There were no statistically significant differences in age , parity , gestational age , history of sexually transmitted disease , pelvic inflammatory disease , or multiple sex partners between the doxycycline and placebo groups . Preoperative gonorrhea or chlamydia isolates were positive in five ( 4.2 % ) and six ( 5 % ) of 120 doxycycline patients and four ( 3.3 % ) and eight ( 6.6 % ) of 120 controls ( not significant ) . All preoperative gonorrhea isolates remained positive postoperatively . Seven ( 5.8 % ) controls had positive postoperative chlamydia isolates , as did one ( 0.8 % ) in the doxycycline group ( P = .06 ) . We diagnosed eight ( 6.6 % ) of 120 doxycycline patients and seven ( 5.8 % ) of 120 controls with infectious morbidity ( not significant ) . Conclusion In our population of patients with incomplete abortion , the prevalence of gonorrhea and chlamydia was low , and prophylactic doxycycline did not decrease the rate of postoperative febrile morbidity",
"The 2007 American Heart Association guidelines for the prevention of infective endocarditis have dramatically reduced both the types of eligible procedures and the types of eligible cardiac lesions that require prophylaxis . Antibiotic prophylaxis to prevent infective endocarditis is not indicated for any patient undergoing obstetric and /or gynaecological procedures , not even for patients with underlying cardiac lesions with the highest risk of developing complications from endocarditis . This sharp departure from previously published guidelines relies on the recognition that endocarditis is more likely to develop from \" r and omly occurring \" bacteremia ( e.g. , from brushing teeth ) than from invasive procedures and that antibiotic prophylaxis has not been proven to be effective . A short discussion on enterococcal infections associated to obstetric and gynaecological procedures and therapeutic implication s is presented"
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BACKGROUND Osteoarthritis is a leading cause of disability . Nonsurgical treatment is a key first step . PURPOSE Systematic literature review of physical therapy ( PT ) interventions for community-dwelling adults with knee osteoarthritis . DATA SOURCES MEDLINE , the Cochrane Library , the Physiotherapy Evidence Data base , Scirus , Allied and Complementary Medicine , and the Health and Psychosocial Instruments bibliography data base . STUDY SELECTION 193 r and omized , controlled trials ( RCTs ) published in English from 1970 to 29 February 2012 . DATA EXTRACTION Means of outcomes , PT interventions , and risk of bias were extracted to pool st and ardized mean differences . Disagreements between review ers abstract ing and checking data were resolved through discussion . DATA SYNTHESIS Meta-analyses of 84 RCTs provided evidence for 13 PT interventions on pain ( 58 RCTs ) , physical function ( 36 RCTs ) , and disability ( 29 RCTs ) . Meta-analyses provided low-strength evidence that aerobic ( 11 RCTs ) and aquatic ( 3 RCTs ) exercise improved disability and that aerobic exercise ( 19 RCTs ) , strengthening exercise ( 17 RCTs ) , and ultrasonography ( 6 RCTs ) reduced pain and improved function . Several individual RCTs demonstrated clinical ly important improvements in pain and disability with aerobic exercise . Other PT interventions demonstrated no sustained benefit . Individual RCTs showed similar benefits with aerobic , aquatic , and strengthening exercise . Adverse events were uncommon and did not deter participants from continuing treatment . LIMITATION Variability in PT interventions and outcomes measures hampered synthesis of evidence . CONCLUSION Low-strength evidence suggested that only a few PT interventions were effective . Future studies should compare combined PT interventions ( which is how PT is generally administered for pain associated with knee osteoarthritis ) . PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality
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"OBJECTIVE To evaluate the effect of weight reduction on the rehabilitation of patients with knee osteoarthritis and obesity . METHODS A total of 126 patients with bilateral knee osteoarthritis and obesity were classified into 3 groups by their stages of osteoarthritis . Each group was divided into subgroups a , b , and c. The subjects in subgroup a received weight reduction treatment , those in subgroup b received weight reduction and electrotherapy modalities , and those in subgroup c received electrotherapy modalities to relieve pain . RESULTS Pain reduction , weight reduction , ambulation speed , and changes of Lequesne 's index were greater in patients in subgroups a and b than in subgroup c after treatment . Although the last pain scores in subgroup b were less than those in subgroup a , as measured by a visual analog scale ( VAS ) , there was no significant difference between their functional status . Significant pain relief ( VAS acceptable functional status ( Lequesne 's index < 7 ) were indicated when weight reduction was more than 15 % and 12 % , respectively , of the initial body weight of the individual . CONCLUSION Weight reduction was found to be a practical adjuvant treatment in the rehabilitation of patients with knee osteoarthritis",
"We recruited 132 subjects with bilateral knee osteoarthritis ( Altman Grade II ) to compare the effects of different stretching techniques on the outcomes of isokinetic muscle strengthening exercises . Patients were r and omly divided into four groups ( I-IV ) . The patients in Group I received isokinetic muscular strengthening exercises , Group II received bilateral knee static stretching and isokinetic exercises , Group III received proprioceptive neuromuscular facilitation ( PNF ) stretching and isokinetic exercises , and Group IV acted as controls . Outcomes were measured by changes in Lequesne 's index , range of knee motion , visual analog pain scale , and peak muscle torques during knee flexion and extension . Patients in all the treated groups experienced significant reductions in knee pain and disability , and increased peak muscle torques after treatment and at follow-up . However , only patients in Groups II and III had significant improvements in range of motion and muscle strength gain during 60 degrees/second angular velocity peak torques . Group III demonstrated the greatest increase in muscle strength gain during 180 degrees/second angular velocity peak torques . In conclusion , stretching therapy could increase the effectiveness of isokinetic exercise in terms of functional improvement in patients with knee osteoarthritis . PNF techniques were more effective than static stretching",
"OBJECTIVE To compare the efficacy of aquatic exercise and a l and -based exercise programme vs control in patients with knee osteoarthritis . METHODS Primary outcome was change in pain , and in addition Knee Injury and Osteoarthritis Outcome Score question naire ( KOOS ) . St and ing balance and strength was also measured after and at 3-month follow-up . Seventy-nine patients ( 62 women ) , with a mean age of 68 years ( age range 40 - 89 years ) were r and omized to aquatic exercise ( n = 27 ) , l and -based exercise ( n = 25 ) or control ( n = 27 ) . RESULTS No effect was observed immediately after exercise cessation ( 8 weeks ) . At 3-month follow-up a reduction in pain was observed only in the l and -based exercise group compared with control ( -8.1 mm , ( 95 % confidence interval -15.4 to -0.4 ; p = 0.039 ) , but no differences between groups were observed for KOOS ; and no improvement following aquatic exercise . Eleven patients reported adverse events ( i.e. discomfort ) in l and -based exercise , while only 3 reported adverse events in the aquatic exercise . CONCLUSION Only l and -based exercise showed some improvement in pain and muscle strength compared with the control group , while no clinical benefits were detectable after aquatic exercise compared with the control group . However , aquatic exercise has significantly less adverse effects compared with a l and -based programme",
"This study examined the effects of dietary weight loss and exercise on the health-related quality of life ( HRQL ) of overweight and obese , older adults with knee osteoarthritis . A total of 316 older men and women with documented evidence of knee osteoarthritis were r and omly assigned to 1 of 4 18-month interventions : dietary weight loss , exercise , dietary weight loss and exercise , or healthy lifestyle control . Measures included the SF-36 Health Survey and satisfaction with body function and appearance . Results revealed that the combined diet and exercise intervention had the most consistent , positive effect on HRQL compared with the control group ; however , findings were restricted to measures of physical health or psychological outcomes that are related to the physical self",
"PURPOSE Individuals with osteoarthritis can experience difficulty walking and poor strength , possibly leading to falls and fractures . Exercise has been found to increase strength and bone mineral density . The purpose of this study was to determine the effects of 6 months of t'ai chi on knee muscle strength , bone mineral density , and fear of falling in older women with osteoarthritis . METHODS Eighty-two ( 82 ) women with osteoarthritis , recruited from outpatient clinics and community health centers , were r and omly assigned to either a t'ai chi group and took part in a t'ai chi program , or a control group . Of these , 30 subjects ( mean age = 63 years ) in the t'ai chi group and 35 ( mean age = 61 years ) in the control group completed post-test measures at 6 months . RESULTS After the 6-month study period , subjects in the t'ai chi program had significantly greater knee extensor endurance ( pre- to post-test mean increase = 36.4 W/kg , versus 1.1 W/kg for the controls ) , and significantly greater bone mineral density in the neck of the proximal femur ( mean change = 0.09 , versus -0.10 for the controls ) , Ward 's triangle ( mean change = 0.04 , versus -0.04 for the controls ) , and trochanter ( mean change = 0.07 , versus -0.05 for the controls ) than the controls . However , knee extensor and flexor strength did not differ significantly between the groups . The fear of falling during daily activities reduced significantly more in the t'ai chi group ( mean change = -2.40 , versus 0.66 for the controls ) . CONCLUSIONS T'ai chi increased knee extensor muscle endurance and bone mineral density in older women with osteoarthritis , and decreased their fear of falling during daily activities . Further study with long-term follow-up is needed to substantiate the role of t'ai chi exercise in the prevention of fall and its related fracture",
"OBJECTIVE To determine whether high exercise adherence improved physical function among older adults with knee osteoarthritis ( OA ) who were overweight or obese . METHODS Associations between exercise adherence , changes in 6-minute walking distance in meters , and self-reported disability ( Western Ontario and McMaster Universities Osteoarthritis Index function subscale ) after 6 and 18 months were examined among an Arthritis , Diet , and Activity Promotion Trial sub sample ( n = 134 ) using multiple linear regression models . RESULTS Higher exercise adherence was associated with greater improvements in 6-minute walking distance after 6 and 18 months and in disability after 6 months . Pain and body mass index ( BMI ) contributed , to some extent , to explaining the link between exercise adherence and changes in physical performance and self-reported disability . CONCLUSION Higher exercise adherence is associated with improved physical function in overweight and obese older adults with knee OA . This indicates that promoting adherence is clinical ly relevant when prescribing exercise regimens that also focus on decreasing pain and BMI",
"BACKGROUND Massage therapy is an attractive treatment option for osteoarthritis ( OA ) , but its efficacy is uncertain . We conducted a r and omized , controlled trial of massage therapy for OA of the knee . METHODS Sixty-eight adults with radiographically confirmed OA of the knee were assigned either to treatment ( twice-weekly sessions of st and ard Swedish massage in weeks 1 - 4 and once-weekly sessions in weeks 5 - 8 ) or to control ( delayed intervention ) . Primary outcomes were changes in the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain and functional scores and the visual analog scale of pain assessment . The sample provided 80 % statistical power to detect a 20-point difference between groups in the change from baseline on the WOMAC and visual analog scale , with a 2-tailed alpha of .05 . RESULTS The group receiving massage therapy demonstrated significant improvements in the mean ( SD ) WOMAC global scores ( -17.44 [ 23.61 ] mm ; P pain ( -18.36 [ 23.28 ] ; P stiffness ( -16.63 [ 28.82 ] mm ; P physical function domains ( -17.27 [ 24.36 ] mm ; P visual analog scale of pain assessment ( -19.38 [ 28.16 ] mm ; P range of motion in degrees ( 3.57 [ 13.61 ] ; P = .03 ) , and time to walk 50 ft ( 15 m ) in seconds ( -1.77 [ 2.73 ] ; P Massage therapy seems to be efficacious in the treatment of OA of the knee . Further study of cost effectiveness and duration of treatment effect is clearly warranted .",
"OBJECTIVE To assess the radiographic and symptomatic effects of treating patients with medial compartment osteoarthritis ( OA ) of the knee with laterally wedged insoles with subtalar strapping of varying elevations . DESIGN Prospect i ve quasi-experimental evaluation . SETTING Outpatient clinic in Japan . PARTICIPANTS Sixty-two women out patients with knee OA who were r and omized into 3 groups according to their birth date s and wedge elevation . INTERVENTIONS Participants wore laterally wedged insoles with subtalar strapping with elevations of 8 , 12 , or 16 mm for 2 weeks . MAIN OUTCOME MEASURES St and ing radiographs were used to analyze the femorotibial angle for each subject , both with and without their respective unilateral insoles . The remission scores of the Lequesne index of severity for knee OA were compared among the 3 groups at the conclusion . Participants were asked to report adverse effects on use of the insoles . RESULTS The 16-mm group ( n=21 ) showed a significantly greater valgus correction of the femorotibial angle than the 8-mm group ( n=20 ) ( P=.013 ) . The remission score was significantly improved in the 12-mm group ( n=21 ) compared with the 16-mm group ( P=.029 ) . Adverse effects were more common in the 16-mm group ( 9/21 , 42.8 % ) than in the 12-mm ( 3/21 , 14.3 % ) or 8-mm ( 2/20 , 10 % ) groups . CONCLUSIONS The degree of change in femorotibial angle with the insole with subtalar strapping was affected by the tilt of the lateral wedge . For constant routine use , the 8- or 12-mm elevation wedged insoles with subtalar strapping may be more comfortable and effective than the 16-mm elevation wedge",
"PURPOSE The purpose s of this study were to assess a ) the effectiveness of Masai Barefoot Technology ( MBT ) shoe in reducing knee pain in persons with knee osteoarthritis ( OA ) and ( b ) changes in balance , ankle and knee ROM , and ankle strength compared with a high-end walking shoe for 12 wk . METHODS The research design was a r and omized controlled trial ( 123 subjects , knee OA ) . Subjects were r and omized to a MBT ( N = 57 ) or a control shoe ( N = 66 ) . A Western Ontario and McMaster Universities ( WOMAC ) OA index , BMI , balance , active ROM , and ankle torque were quantified at week 0 , 3 , 6 , 9 , and 12 . Two- sample t-tests were done for between-group comparisons . RESULTS There was no significant difference between groups in total pain score . A significant reduction over the 12-wk period was found for both shoe conditions ( -42/500 or 25.6 % MBT , -46.2 or 27.1 % control ) . There was no significant group difference in pain during walking ( t = -1.09 , P = 0.28 ) . Pain during walking was significantly reduced by 5.2/100 mm in the MBT and 9.7/100 mm in the control group . Total pain showed a significant reduction for the MBT -27.4/500 ( -16.6 % ) and the control group -28.9/500 ( -17.0 % ) between baseline and week 3 . Between week 3 and 6 , there was a significant reduction for the MBT group only ( -27.2/500 or -20.0 % ) . There was a significant increase in the static balance between baseline and 12 wk in the MBT group only , although the difference between groups was not significant . DISCUSSION The results indicate that special shoe interventions can reduce pain in subjects with moderate knee OA",
"Objectives .To estimate cost and outcomes of the Arthritis Foundation aquatic exercise classes from the societal perspective . Design .R and omized trial of 20-week aquatic classes . Cost per quality -adjusted life year ( QALY ) gained was estimated using trial data . Sample size was based on 80 % power to reject the None hypothesis that the cost/QALY gained would not exceed $ 50,000 . Subjects and Methods . Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis to participate in aquatic classes . The Quality of Well-Being Scale ( QWB ) and Current Health Desirability Rating ( CHDR ) were used for economic evaluation , supplemented by the arthritis-specific Health Assessment Question naire ( HAQ ) , Center for Epidemiologic Studies -Depression Scale ( CES-D ) , and Perceived Quality of Life Scale ( PQOL ) collected at baseline and postclass . Outcome results applied to life expectancy tables were used to estimate QALYs . Use of health care facilities was assessed from diaries/ question naires and Medicare reimbursement rates used to estimate costs . Nonparametric bootstrap sampling of costs/QALY ratios established the 95 % CI around the estimates . Results .Aquatic exercisers reported equal ( QWB ) or better ( CHDR , HAQ , PQOL ) health-related quality of life compared with controls . Outcomes improved with regular class attendance . Costs/QALY gained discounted at 3 % were $ 205,186 using the QWB and $ 32,643 using the CHRD . Conclusion .Aquatic exercise exceeded $ 50,000 per QALY gained using the community-weighted outcome but fell below this arbitrary budget constraint when using the participant-weighted measure . Confidence intervals around these ratios suggested wide variability of cost effectiveness of aquatic exercise",
"OBJECTIVE The Arthritis , Diet , and Activity Promotion Trial ( ADAPT ) was a r and omized , single-blind clinical trial lasting 18 months that was design ed to determine whether long-term exercise and dietary weight loss are more effective , either separately or in combination , than usual care in improving physical function , pain , and mobility in older overweight and obese adults with knee osteoarthritis ( OA ) . METHODS Three hundred sixteen community-dwelling overweight and obese adults ages 60 years and older , with a body mass index of > or = 28 kg/m(2 ) , knee pain , radiographic evidence of knee OA , and self-reported physical disability , were r and omized into healthy lifestyle ( control ) , diet only , exercise only , and diet plus exercise groups . The primary outcome was self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Secondary outcomes included weight loss , 6-minute walk distance , stair-climb time , WOMAC pain and stiffness scores , and joint space width . RESULTS Of the 316 r and omized participants , 252 ( 80 % ) completed the study . Adherence was as follows : for healthy lifestyle , 73 % ; for diet only , 72 % ; for exercise only , 60 % ; and for diet plus exercise , 64 % . In the diet plus exercise group , significant improvements in self-reported physical function ( P 6-minute walk distance ( P stair-climb time ( P knee pain ( P 6-minute walk distance ( P . The weight-loss groups lost significantly ( P body weight ( for diet , 4.9 % ; for diet plus exercise , 5.7 % ) than did the healthy lifestyle group ( 1.2 % ) . Finally , changes in joint space width were not different between the groups . CONCLUSION The combination of modest weight loss plus moderate exercise provides better overall improvements in self-reported measures of function and pain and in performance measures of mobility in older overweight and obese adults with knee OA compared with either intervention alone",
"Background Studies on exercise in knee osteoarthritis ( OA ) have focused on elderly subjects . Subjects in this study were middle-aged with symptomatic and definite radiographic knee osteoarthritis . The aim was to test the effects of a short-term , high-intensity exercise program on self-reported pain , function and quality of life . Methods Patients aged 36–65 , with OA grade III ( Kellgren & Lawrence ) were recruited . They had been referred for radiographic examination due to knee pain and had no history of major knee injury . They were r and omized to a twice weekly supervised one hour exercise intervention for six weeks , or to a non-intervention control group . Exercise was performed at ≥ 60 % of maximum heart rate ( HR max ) . The primary outcome measure was the Knee injury and Osteoarthritis Outcome Score ( KOOS ) . Follow-up occurred at 6 weeks and 6 months . Results Sixty-one subjects ( mean age 56 ( SD 6 ) , 51 % women , mean BMI 29.5 ( SD 4.8 ) ) were r and omly assigned to intervention ( n = 30 ) or control group ( n = 31 ) . No significant differences in the KOOS subscales assessing pain , other symptoms , or function in daily life or in sport and recreation were seen at any time point between exercisers and controls . In the exercise group , an improvement was seen at 6 weeks in the KOOS subscale quality of life compared to the control group ( mean change 4.0 vs. -0.7 , p = 0.05 ) . The difference between groups was still persistent at 6 months ( p = 0.02 ) . Conclusion A six-week high-intensive exercise program had no effect on pain or function in middle-aged patients with moderate to severe radiographic knee OA . Some effect was seen on quality of life in the exercise group compared to the control group",
"The purpose of this study was to compare the effectiveness of transcutaneous nerve stimulation ( TENS ) , electroacupuncture ( EA ) , and ice massage with placebo treatment for the treatment of pain . Subjects ( n = 100 ) diagnosed with osteoarthritis ( OA ) of the knee were treated with these modalities . The parameters for evaluating the effectiveness of treatment include pain at rest , stiffness , 50 foot walking time , quadriceps muscle strength , and knee flexion degree . The results showed ( a ) that all three methods could be effective in decreasing not only pain but also the objective parameters in a short period of time ; and ( b ) that the treatment results in TENS , EA and ice massage were superior to placebo",
"Background The present study tests whether a combined treatment of acupuncture and transcutaneous electrical nerve stimulation ( TENS ) is more effective than acupuncture or TENS alone for treating knee osteoarthritis ( OA ) . Methods Thirty-two patients with knee OA were r and omly allocated to four groups . The acupuncture group ( ACP ) received only acupuncture treatment at selected acupoints for knee pain ; the TENS group ( TENS ) received only TENS treatment at pain areas ; the acupuncture and TENS group ( A&T ) received both acupuncture and TENS treatments ; the control group ( CT ) received topical poultice ( only when necessary ) . Each group received specific weekly treatment five times during the study . Outcome measures were pain intensity in a visual analogue scale ( VAS ) and knee function in terms of the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . Results The ACP , TENS and A&T groups reported lower VAS and WOMAC scores than the control group . Significant reduction in pain intensity ( P = 0.039 ) and significant improvement in knee function ( P = 0.008 ) were shown in the A&T group . Conclusion Combined acupuncture and TENS treatment was effective in pain relief and knee function improvement for the sample d patients suffering from knee OA",
"OBJECTIVE To compare the clinical effects of laterally wedged insoles and neutrally wedged insoles ( used as control ) in patients with medial femoro-tibial knee osteoarthritis ( OA ) . DESIGN 6-month prospect i ve r and omized controlled study . PATIENTS out patients with painful medial femoro-tibial knee OA . OUTCOME MEASURES patient 's overall assessment of disease activity ( 5 grade scale ) , WOMAC index subscales and concomitant treatments . STATISTICAL ANALYSIS Performed as an intention-to-treat analysis . Main criterion : improvement in the patient 's assessment of activity ( defined as a reduction of 1 grade or more at month 6 compared to baseline , and no intraarticular injection or lavage during the study ) . Secondary criteria for assessment : ( a ) improvement in the patient 's assessment of activity at months 1 and 3 compared to baseline , ( b ) improvement in the WOMAC subscales at months 1 , 3 and 6 , compared to baseline ( defined as an improvement of at least 30 % , and no intraarticular injection or lavage during the study ) and ( c ) concomitant therapies ( analgesics and NSAIDs ) . RESULTS The baseline characteristics of the 156 recruited patients ( 41 males , 115 females , mean age 64.8 years ) were not different in the two treatment groups . At months 1 , 3 and 6 the percentages of patients with improvement in assessment of disease activity , in WOMAC pain , joint stiffness , and physical functioning subscales were similar in the two groups . The number of days with NSAIDs intake during the previous 3 months was decreased at month 6 compared with baseline in the group furnished with laterally wedged insoles ( 14.1 days+/-28 vs 9.9 days+/-27 , P=0.04 , Wilcoxon paired test ) , while it remained unchanged in the other group ( 15.5 days+/-24 vs 15+/-28 , P=0.56 ) . Compliance and tolerance were satisfactory . Compliance was different between the two groups at month 6 , with a greater frequency of patients who wore insoles permanently in the laterally wedged insole group than in the other group ( 87.8 % vs 74.3%;P=0.032 ) . CONCLUSION This study failed to demonstrate a relevant short-term symptomatic effect of laterally-wedged insoles in medial femoro-tibial OA . However , the decrease in NSAIDs consumption together with better compliance in the treated group are in favor of a beneficial effect of laterally-wedged insoles in medial femoro-tibial OA",
"Background This study examined the effect of treatment with a novel biomechanical device on the level of pain and function in patients with knee OA . Methods Patients with bilateral knee OA were enrolled to active and control groups . Patients were evaluated at baseline , at 4 weeks and at the 8-week endpoint . A novel biomechanical device was individually calibrated to patients from the active group . Patients from the control group received an identical foot-worn platform without the biomechanical elements . Primary outcomes were the WOMAC Index and ALF assessment s. Results There were no baseline differences between the groups . At 8 weeks , the active group showed a mean improvement of 64.8 % on the WOMAC pain scale , a mean improvement of 62.7 % on the WOMAC function scale , and a mean improvement of 31.4 % on the ALF scale . The control group demonstrated no improvement in the above parameters . Significant differences were found between the active and control groups in all the parameters of assessment . Conclusions The biomechanical device and treatment methodology is effective in significantly reducing pain and improving function in knee OA patients .The study is registered at clinical trials.gov , identifier NCT00457132 , http://www . clinical",
"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",
"Objective : This investigation assessed preferences for , and effects of , 5 days of twice daily superficial heat , cold , or contrast therapy applied with a commercially available system permitting the circulation of water through a wrap-around garment , use of an electric heating pad , or rest for patients with level II – IV osteoarthritis ( OA ) of the knee . Methods : We employed a within subject , r and omized order design to study 34 patients receiving each treatment in 1-week blocks . A knee injury and osteoarthritis outcome score ( KOOS ) question naire and visual analog pain scale was completed at baseline , and twice each week . Treatment preferences were assessed in the last week of the study . Results : Treatment with the device set to warm was preferred by 48 % of subjects . Near equal preferences were observed for cold ( 24 % ) and contrast ( 24 % ) . Pain reduction and improvements in KOOS subscale measures were demonstrated for each treatment but responses were ( P water circulating garment system over a heating pad . Conclusions : We recommend that when superficial heat or cold is considered in the management of knee OA that patients experiment to identify the intervention that offers them the greatest relief and that contrast is a treatment option",
"Objectives To evaluate the effectiveness of two primary care strategies for delivering evidence based care to people aged 55 or over with knee pain : enhanced pharmacy review and community physiotherapy . Design Pragmatic multicentre r and omised clinical trial . Setting 15 general practice s in North Staffordshire . Participants 325 adults aged 55 years or over ( mean 68 years ) consulting with knee pain ; 297 ( 91 % ) reached six month follow-up . Interventions Enhanced pharmacy review ( pharmacological management in accordance with an algorithm ) ; community physiotherapy ( advice about activity and pacing and an individualised exercise programme ) ; control ( advice leaflet reinforced by telephone call ) . Main outcome measure Change in Western Ontario and McMaster Universities osteoarthritis index ( WOMAC ) at 3 , 6 , and 12 months . Results Mean baseline WOMAC pain score was 9.1 ( SD 3.7 ) , and mean baseline function score was 29.9 ( SD 12.8 ) . At three months , the mean reductions in pain scores were 0.41 ( SD 2.8 ) for control , 1.59 ( 3.2 ) for pharmacy , and 1.56 ( 3.4 ) for physiotherapy ; reductions in function scores were 0.80 ( 8.5 ) , 2.61 ( 9.8 ) , and 4.79 ( 10.8 ) . Compared with control , mean differences in change scores for physiotherapy were 1.15 ( 95 % confidence interval 0.2 to 2.1 ) for pain and 3.99 ( 1.2 to 6.8 ) for function ; those for pharmacy were 1.18 ( 0.3 to 2.1 ) for pain and 1.80 ( −0.8 to 4.5 ) for function . These differences were not sustained to six or 12 months . Significantly fewer participants in the physiotherapy group reported consulting their general practitioner for knee pain in the follow-up period , and use of non-steroidal anti-inflammatory drugs was lower in the physiotherapy and pharmacy groups than in the control group . Conclusions Evidence based care for older adults with knee pain , delivered by primary care physiotherapists and pharmacists , result ed in short term improvements in health outcomes , reduced use of non-steroidal anti-inflammatory drugs , and high patient satisfaction . Physiotherapy seemed to produce a shift in consultation behaviour away from the traditional general practitioner led model of care . Trial registration UK National Research Register N0286046917 ; Current Controlled Trials IS RCT N55376150",
"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",
"OBJECTIVE To assess the optimal duration of daily wear for a laterally wedged insole with subtalar strapping in subjects with medial compartment osteoarthritis of the knee ( knee OA ) . DESIGN The setting was an outpatient clinic . Eighty-one patients with knee OA were prospect ively r and omized according to birth date and to either 2 weeks of treatment with a lateral wedge with subtalar strapping for less than 5 h ( the short group ) , 5 - 10 h ( the medium group ) or greater than 10 h ( the long group ) each day , or to treatment with a subtalar strapping b and without lateral wedge ( the placebo group ) . St and ing radiographs were used to analyze the femorotibial angle for each subject , both with and without their respective orthotic device . The remission scores of Lequesne index were compared among the four groups at the conclusion . RESULTS The short ( n=21 ) , medium ( n=20 ) and long ( n=18 ) groups demonstrated a significant greater valgus correction of the femorotibial angle than the placebo group ( n=22 ) ( P remission score was significantly improved in the medium group compared to the placebo ( P=0.001 ) and long ( P=0.001 ) groups . CONCLUSIONS An optimal duration of insole with subtalar strapping wear for patients with varus deformity knee OA may be between 5 and 10 h each day",
"BACKGROUND The prevention of disability in activities of daily living ( ADL ) may prolong older persons ' autonomy ( older persons are defined in this study as those aged > or = 60 years ) . However , proved preventive strategies for ADL disability are lacking . A sedentary lifestyle is an important cause of disability . This study examines whether an exercise program can prevent ADL disability . METHODS A 2-center , r and omized , single-blind , controlled trial was conducted in which participants were assigned to an aerobic exercise program , a resistance exercise program , or an attention control group . Of the 439 community-dwelling persons aged 60 years or older with knee osteoarthritis originally recruited , the 250 participants initially free of ADL disability were used for this study . Incident ADL disability , defined as developing difficulty in transferring from a bed to a chair , eating , dressing , using the toilet , or bathing , was assessed quarterly during 18 months of follow-up . RESULTS The cumulative incidence of ADL disability was lower in the exercise groups ( 37.1 % ) than in the attention control group ( 52.5 % ) ( P = .02 ) . After adjustment for demographics and baseline physical function , the relative risk of incident ADL disability for assignment to exercise was 0.57 ( 95 % confidence interval , 0.38 - 0.85 ; P = .006 ) . Both exercise programs prevented ADL disability ; the relative risks were 0.60 ( 95 % confidence interval , 0.38 - 0.97 ; P = .04 ) for resistance exercise and 0.53 ( 95 % confidence interval , 0.33 - 0.85 ; P = .009 ) for aerobic exercise . The lowest ADL disability risks were found for participants with the highest compliance to exercise . CONCLUSIONS Aerobic and resistance exercise may reduce the incidence of ADL disability in older persons with knee osteoarthritis . Exercise may be an effective strategy for preventing ADL disability and , consequently , may prolong older persons ' autonomy",
"The aim of this study was to evaluate the effects of electrical stimulation program on pain , disability , and quadriceps strength in the patients with knee osteoarthritis . Fifty women diagnosed as knee osteoarthritis were r and omized into two groups as electrical stimulation and biofeedback-assisted isometric exercises . Both of the programs were performed 5 days a week , for a duration of 4 weeks . Outcome measures for pain were visual analogue scale pain score and Western Ontario McMaster osteoarthritis index ( WOMAC ) pain score . Disability and stiffness were assessed with WOMAC physical function and stiffness score . One repetition maximum ( RM ) and 10 RM were used for measuring quadriceps strength . In addition , 50 m walking time and 10 steps stairs climbing up-down time were evaluated . Both groups showed significant improvements in pain , physical function , and stiffness scores after the therapy . There were statistically significant improvements in 50 m walking time and 10 steps stairs climbing up-down time and 1 RM and 10 RM values indicating the improvement in muscle strength . In addition , there were no significant differences between the groups after the therapy . We conclude that electrical stimulation treatment was as effective as exercise in knee osteoarthritis and electrical stimulation treatment can be suggested especially for the patients who have difficulty in or contraindications to perform an exercise program",
"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",
"This paper reports the results of a study of the gait of 102 patients with osteoarthritis of the knee . Functional status was measured by a 6-min test of walking distance ; the stride characteristics associated with the walk test were assessed . Stride characteristics were measured by a Stride Analyzer . Patients were r and omized to an 8-week educational and walking program ( the intervention group ) or to a weekly telephone survey ( the control group ) . The intervention group patients had a 15 % increase in walking distance ( P stride length at free walking speeds ( P stride length at fast walking speeds ( P walking and educational program was effective in improving gait function in patients with osteoarthritis of the knee",
"Abstract Objectives To test the hypotheses that therapeutic taping of the knee improves pain and disability in patients with osteoarthritis of the knee and that benefits remain after stopping treatment . Design R and omised single blind controlled trial with three intervention arms ( therapeutic tape , control tape , and no tape ) of three weeks ' duration and three week follow up . Setting Outcome assessment was performed in a university based laboratory . Taping interventions were applied by eight physiotherapists in metropolitan private practice . Participants 87 patients with symptoms of knee osteoarthritis as defined by the American College of Rheumatology . Main outcome measures Primary outcome measure was pain as measured by visual analogue scale and participant perceived rating of change . Secondary measures of pain and disability included the Western Ontario and MacMaster Universities osteoarthritis index , knee pain scale , and the SF-36 . Results The therapeutic tape group reported a greater reduction in pain on all primary outcomes than either of the other two groups . A significant association was evident between intervention and change in pain at three weeks ( P=0.000 ) , with 73 % ( 21/29 ) of the therapeutic tape group reporting improvement compared with 49 % ( 14/29 ) of the control tape group and 10 % ( 3/29 ) of the no tape group . Significantly greater improvement in pain and disability was observed on most secondary outcomes in the therapeutic tape group compared with the no tape group . Benefits of therapeutic tape were maintained three weeks after stopping treatment . Conclusions Therapeutic knee taping is an efficacious treatment for the management of pain and disability in patients with knee osteoarthritis",
"OBJECTIVE To determine the minimal perceptible clinical improvement ( MPCI ) in patients with osteoarthritis ( OA ) with the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) question naire , and patient and investigator global assessment of disease status in r and omized clinical trials for treatment of OA . METHODS Subjects with OA of the knee or hip were r and omized to receive either rofecoxib 12.5 or 25 mg once daily , ibuprofen 800 mg 3 times daily , or placebo for 6 weeks . The WOMAC and global assessment s were completed at baseline and Weeks 2 , 4 , and 6 . A patient global assessment of response to therapy ( 0 to 4 scale ) was used to \" anchor \" the WOMAC scores . MPCI was defined as the difference in mean change from baseline in WOMAC ( 100 mm normalized visual analog scale , VAS ) between patients with 0 = \" None \" global response to therapy and patients with 1 = \" Poor \" global response to therapy . RESULTS MPCI was determined to be 9.7 , 9.3 , and 10.0 mm for the WOMAC pain , physical function and stiffness subscales , respectively , and 11.1 mm for WOMAC question 1 : Pain walking on a flat surface . The MPCI for the investigator was 0.4 with investigator assessment of disease status reported on a 0 to 4 Likert scale . Of note , the estimated MPCI for the WOMAC and investigator globals were similar irrespective of treatment , sex , age , or geographic region . CONCLUSION In this analysis , mean changes of roughly 9 to 12 mm ( 100 mm normalized VAS ) on WOMAC scales were perceptible changes to patients with hip and knee OA . A mean decrease of 0.4 in global disease status ( 0 to 4 Likert scale ) as assessed by the investigator corresponded to the patients ' MPCI . Underst and ing the minimal perceptible differences may permit a better assessment of the clinical relevance of therapeutic interventions in OA",
"Patients with knee osteoarthrosis are often referred for physiotherapy and many different types of treatment are given . The value of many of these treatments has been question ed . This study was intended to evaluate the effect of commonly used physiotherapy treatments in a training programme on patients with medial knee osteoarthrosis , scheduled for surgery . The results from this study also provide useful data for further evaluation of different physiotherapy treatments to this patient group . Thirty-four patients were r and omised to physiotherapy three times a week for 5 weeks and the other 34 received no treatment . The training programme is described in detail . The patients were evaluated by clinical examination , step test , gait analysis and isokinetic measurements of thigh muscle strength before and after treatment . The patients in the treatment group experienced a feeling of overall improvement in the knee and the ability to descend steps improved when compared to the control group . There were no significant differences in gait , range of motion or isokinetic measurements of muscle strength between the groups . We conclude that physiotherapy as given here made our patients feel better and their ability to descend stairs improved . These improvements are beneficial to the patients and support the positive effects of exercises and activity . Whilst the objective improvements were small , suggesting that this treatment may not be justified , patients in the treatment group believed that they were improved",
"OBJECTIVES To evaluate the effects of two knee taping techniques , therapeutic tape and neutral tape , on pain and observed disability in symptomatic generalized knee osteoarthritis ( OA ) . METHODS Using a within-subjects study design , 18 participants were tested under three conditions in r and om order : untaped , wearing therapeutic knee tape and wearing neutral knee tape . Outcome measures included assessment of pain during each of four activities ( using a visual analogue scale ) and assessment of observed disability ( walking speed , timed up and go test , and the step test ) . RESULTS Therapeutic tape significantly reduced pain on three of the four activities assessed , when compared with the neutral and untaped conditions ( P observed disability was detected in the step test ( P therapeutic tape . CONCLUSIONS Therapeutic knee tape is a simple , inexpensive strategy that increases the treatment options for therapists and patients in the conservative management of knee OA . Whilst effective in immediately reducing pain , it does not appear to have a significant immediate impact on observed disability associated with the disease . Therapeutic tape may be used as an adjunct to drug and exercise therapies , potentially augmenting the individual benefits of each",
"OBJECTIVE To determine whether a multimodal physiotherapy programme including taping , exercises , and massage is effective for knee osteoarthritis , and if benefits can be maintained with self management . METHODS R and omised , double blind , placebo controlled trial ; 140 community volunteers with knee osteoarthritis participated and 119 completed the trial . Physiotherapy and placebo interventions were applied by 10 physiotherapists in private practice s for 12 weeks . Physiotherapy included exercise , massage , taping , and mobilisation , followed by 12 weeks of self management . Placebo was sham ultrasound and light application of a non-therapeutic gel , followed by no treatment . Primary outcomes were pain measured by visual analogue scale and patient global change . Secondary measures included WOMAC , knee pain scale , SF-36 , assessment of quality of life index , quadriceps strength , and balance test . RESULTS Using an intention to treat analysis , physiotherapy and placebo groups showed similar pain reductions at 12 weeks : -2.2 cm ( 95 % CI , -2.6 to -1.7 ) and -2.0 cm ( -2.5 to -1.5 ) , respectively . At 24 weeks , pain remained reduced from baseline in both groups : -2.1 ( -2.6 to -1.6 ) and -1.6 ( -2.2 to -1.0 ) , respectively . Global improvement was reported by 70 % of physiotherapy participants ( 51/73 ) at 12 weeks and by 59 % ( 43/73 ) at 24 weeks . Similarly , global improvement was reported by 72 % of placebo participants ( 48/67 ) at 12 weeks and by 49 % ( 33/67 ) at 24 weeks ( all p>0.05 ) . CONCLUSIONS The physiotherapy programme tested in this trial was no more effective than regular contact with a therapist at reducing pain and disability",
"Abstract Objectives : To determine whether a home based exercise programme can improve outcomes in patients with knee pain . Design : Pragmatic , factorial r and omised controlled trial of two years ' duration . Setting : Two general practice s in Nottingham . Participants : 786 men and women aged—45 years with self reported knee pain . Interventions : Participants were r and omised to four groups to receive exercise therapy , monthly telephone contact , exercise therapy plus telephone contact , or no intervention . Patients in the no intervention and combined exercise and telephone groups were r and omised to receive or not receive a placebo health food tablet . Main outcome measures : Primary outcome was self reported score for knee pain on the Western Ontario and McMaster universities ( WOMAC ) osteoarthritis index at two years . Secondary outcomes included knee specific physical function and stiffness ( scored on WOMAC index ) , general physical function ( scored on SF-36 question naire ) , psychological outlook ( scored on hospital anxiety and depression scale ) , and isometric muscle strength . Results : 600 ( 76.3 % ) participants completed the study . At 24 months , highly significant reductions in knee pain were apparent for the pooled exercise groups compared with the non-exercise groups ( mean difference -0.82 , 95 % confidence interval -1.3 to -0.3 ) . Similar improvements were observed at 6 , 12 , and 18 months . Regular telephone contact alone did not reduce pain . The reduction in pain was greater the closer patients adhered to the exercise plan . Conclusions : A simple home based exercise programme can significantly reduce knee pain . The lack of improvement in patients who received only telephone contact suggests that improvements are not just due to psychosocial effects because of contact with the therapist",
"OBJECTIVE To determine whether hip abductor and adductor muscle strengthening reduces medial compartment knee load and improves symptoms in people with medial tibiofemoral OA and varus malalignment . METHODS In a r and omised controlled trial , 89 participants were r and omly allocated to a hip strengthening group or to a control group with no intervention . The strengthening group performed a physiotherapist-supervised home exercise program targeting the hip abductor and adductor muscles for 12 weeks . The primary outcome was the peak external knee adduction moment measured using three-dimensional gait analysis by a blinded assessor . Secondary outcomes included a pain numeric rating scale , Western Ontario and McMaster Universities Osteoarthritis Index , step test , stair climb test , maximum isometric strength of hip and quadriceps muscles and participant-perceived rating of overall change . Intention-to-treat analyses were performed using linear regression modelling adjusting for baseline outcomes and other characteristics . RESULTS The trial was completed by 76/89 participants ( 85 % ) . There was no significant between-group difference in change in the knee adduction moment [ mean difference ( 95 % confidence interval ( CI ) ) 0.134 ( -0.069 to 0.337 ) Nm/BW x HT% ] . All pain , physical function and muscle strength measures showed significantly greater improvement in the strengthening group ( all P<0.05 ) . The relative risk ( 95 % CI ) of participant-perceived overall improvement in the strengthening group compared to the control group was 20.02 ( 6.21 - 64.47 ) . CONCLUSIONS Although strengthening the hip muscles improved symptoms and function in this patient group , it did not affect medial knee load as measured by the knee adduction moment . Thus it is unlikely that hip muscle strengthening influences structural disease progression . TRIAL REGISTRATION ACTR12607000001493",
"OBJECTIVES To assess the feasibility and safety of using the health-promoting traditional Chinese exercise , known as Baduanjin , in treating knee osteoarthritis ( OA ) . SUBJECTS Twenty-eight ( 28 ) female patients who met the American College of Rheumatology criteria for osteoarthritis of the knee signed the informed consent and were r and omized into the Baduanjin group ( n=14 ) and the control group ( n=14 ) . Eleven ( 11 ) patients in the Baduanjin group and 10 patients in the control group completed the trial . INTERVENTION The Baduanjin group patients exercised following taped comm and s in the community entertainment room during 30-minute classes five times a week for 8 weeks , whereas the control group received no treatment . OUTCOME MEASURES Indicators that include knee pain , stiffness , physical disability , general health , quadriceps strength , and aerobic ability were measured using the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , the Medical Outcomes Study Short Form-36 ( SF-36 ) , the 6-Minute Walk Test ( 6-MWT ) , and the Isokinetic Strength of the Knee Extensors ( ISKE ) . RESULTS Compared with the control group , the participants in the Baduanjin group had statistically significant improvements in percentage changes of the WOMAC pain subscale ( -61.8+/-35.7 % versus 44.6+/-102.8 % ; p=0.006 ) , the WOMAC stiffness subscale ( -53.4+/-46.1 % versus 135.8+/-386.7 % ; p=0.029 ) , the WOMAC physical function subscale ( -7.4+/-81.9 % versus 140.5+/-151.9 % ; p=0.024 ) , 6-MWT ( 11.9+/-7.5 % versus 1.6+/-13.0 % ; p=0.036 ) , and Peak Torque of the ISKE ( 15.1+/-33.7 % versus -16.1+/-16.6 % ; p=0.016 ) . The SF-36 's General Health , Social Function , and Mental Health subscales had no significant changes between those in the Baduanjin and control groups . As such , no adverse events from treatment were reported . CONCLUSIONS This study suggested that the Baduanjin exercise provided a safe and feasible treatment option for patients with knee OA , as well as offered reductions in pain , stiffness , and disability , which helped improve the patients ' quadriceps strength and aerobic ability",
"Objective : To evaluate the effects of tai chi consisting of group and home-based sessions in elderly subjects with knee osteoarthritis . Design : A r and omized , controlled , single-blinded 12-week trial with stratification by age and sex , and six weeks of follow-up . Setting : General community . Participants : Forty-one adults ( 709 / 9.2 years ) with knee osteoarthritis . Interventions : The tai chi programme featured six weeks of group tai chi sessions , 40 min/session , three times a week , followed by another six weeks ( weeks 7 -12 ) of home-based tai chi training . Subjects were requested to discontinue tai chi training during a six-week follow-up detraining period ( weeks 13 - 18 ) . Subjects in the attention control group attended six weeks of health lectures following the same schedule as the group-based tai chi intervention ( weeks 0 -6 ) , followed by 12 weeks of no activity ( weeks 7 - 18 ) . Main outcome measures : Knee pain measured by visual analogue scale , knee range of motion and physical function measured by Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) were recorded at baseline and every three weeks throughout the 18-week study period . Data were analysed using a mixed model ANOVA . Results : The six weeks of group tai chi followed by another six weeks of home tai chi training showed significant improvements in mean overall knee pain ( P = 0.0078 ) , maximum knee pain ( P = 0.0035 ) and the WOMAC subscales of physical function ( P = 0.0075 ) and stiffness ( P = 0.0206 ) compared to the baseline . No significant change of any outcome measure was noted in the attention control group throughout the study . The tai chi group reported lower overall pain and better WOMAC physical function than the attention control group at weeks 9 and 12 . All improvements disappeared after detraining",
"OBJECTIVE To evaluate the effect of a brace intended to reduce load in patients with medial or lateral compartmental osteoarthritis ( OA ) and concurrent varus or valgus alignment , respectively . DESIGN This multi-centre r and omized controlled trial ( performed 2001 - 2003 ) studies the additive effect of a brace intended to reduce load in conservative treatment of unicompartmental OA of the knee . SETTING Orthopedic department of a university medical centre and of one general hospital . The follow-up was 12 months . PATIENTS 117 patients with unicompartmental OA of the knee . Intervention group ( n=60 ) comprising conservative treatment with additional brace treatment and a control group ( n=57 ) comprising conservative treatment alone . PRIMARY OUTCOME MEASURES Pain severity and knee function score . SECONDARY OUTCOME MEASURES Walking distance and quality of life . ANALYSIS Multiple linear regression models according to the intention-to-treat-principle were used to assess outcome differences for the entire group of patients . In addition , we performed explorative subgroup analyses on primary overall outcomes stratified for alignment , degree of OA , origin of OA , and age . RESULTS Although the primary outcome measures were improved in the intervention group in comparison with the controls at each assessment point , the differences reached only borderline significance . The reported walking distances at 3 months , 12 months and overall were significantly longer in the brace group ( P=0.03 , P=0.04 and P=0.02 , respectively ) . Subgroup analysis showed a better effect in the varus group , in patients with severe OA , in patients with secondary OA and in patients younger then 60 years . In total 25 patients in the brace group and 14 in the control group changed their initial treatment , mostly ( 74 % ) because of a lack of beneficial effect . CONCLUSIONS The results indicate that a brace intended to reduce load shows small effects in patients with unicompartmental OA . However , many patients do not adhere in the long run to this kind of conservative treatment",
"OBJECTIVE This 8 week r and omized , double blind clinical trial compared the effect of a combined home based progressive exercise program and treatment with the nonsteroidal medication oxaprozin to treatment with oxaprozin alone on pain and physical functioning in older community dwelling patients with unilateral knee osteoarthritis ( OA ) . METHODS Efficacy variables measured before and after 8 weeks included ( 1 ) pain using the Western Ontario McMaster ( WOMAC ) pain , physical disability , and stiffness subscales and a 10 point visual analog scale ( VAS ) before and after self-paced walking ( SPW ) and stepping ( SPS ) functional tasks ; ( 2 ) physical function using the time to complete a self-paced 40 m walk ( SPW ) and 20 cycles of 2 steps ( SPS ) : ( 3 ) physical activity level using the Physical Activity Scale for Elderly ( PASE ) ; ( 4 ) clinical measures of knee functioning ( range of motion ) . One hundred seventy-nine men and women ( mean age 74 + /- 6 yrs ) with radiographic evidence of mild/moderate medial compartment OA were r and omized to either a progressive home based knee exercise program ( n = 88 ) or a control program ( n = 89 ) . All patients were given oxaprozin 1,200 mg per os daily . RESULTS We observed significant reduction from baseline in activity related pain ( VAS ) ; and improvement in SPW and SPS test time , passive range of motion , and PASE after 8 weeks in both groups . These changes were significantly greater ( p progressive exercise program to nonsteroidal antiinflammatory therapy in patients with knee OA can improve measures of activity and activity related pain more than medication alone",
"Cetin N , Aytar A , Atalay A , Akman MN : Comparing hot pack , short-wave diathermy , ultrasound , and TENS on isokinetic strength , pain , and functional status of women with osteoarthritic knees : a single-blind , r and omized , controlled trial . Am J Phys Med Rehabil 2008;87:443–451 . Objective : To investigate the therapeutic effects of physical agents administered before isokinetic exercise in women with knee osteoarthritis . Design : One hundred patients with bilateral knee osteoarthritis were r and omized into five groups of 20 patients each : group 1 received short-wave diathermy + hot packs and isokinetic exercise ; group 2 received transcutaneous electrical nerve stimulation + hot packs and isokinetic exercise ; group 3 received ultrasound + hot packs and isokinetic exercise ; group 4 received hot packs and isokinetic exercise ; and group 5 served as controls and received only isokinetic exercise . Results : Pain and disability index scores were significantly reduced in each group . Patients in the study groups had significantly greater reductions in their visual analog scale scores and scores on the Lequesne index than did patients in the control group ( group 5 ) . They also showed greater increases than did controls in muscular strength at all angular velocities . In most parameters , improvements were greatest in groups 1 and 2 compared with groups 3 and 4 . Conclusions : Using physical agents before isokinetic exercises in women with knee osteoarthritis leads to augmented exercise performance , reduced pain , and improved function . Hot pack with a transcutaneous electrical nerve stimulator or short-wave diathermy has the best outcome",
"Objective : To evaluate the effects of Tai Chi Qigong training on the quality of life and physical function of patients with osteoarthritis of the knee . Design : A preliminary , single-blind , r and omized controlled trial . Setting : General community , performed at Hwaseong City Health Center . Participants : Forty-four elderly subjects ( mean age , 69.1 ± 5.4 years ) with knee osteoarthritis . Intervention : The patients were r and omized ( 2:1 ) to : ( 1 ) an eight-week Tai Chi Qigong training programme or ( 2 ) a waiting list control group . The programme involved eight weeks of group Tai Chi Qigong sessions , with 60 minutes per session twice a week . Main outcome measures : The primary outcome was quality of life measured with the Short Form 36 ( SF-36 ) at baseline and week 8 . Secondary outcomes included the Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) and 6-m walking time . Results : The training group had statistically significant improvements in the quality of life ( changes of SF-36 , Qigong versus control : 21.6 ± 16.8 versus 9.8 ± 13.6 , P and 6-m walking test ( change in walking time , Qigong versus control : —1.6 ± 1.7 versus —0.2 ± 0.8 s , P scores in the training group were markedly improved , although the differences were not statistically significant . Conclusions : Tai Chi Qigong training appears to have beneficial effects in terms of the quality of life and physical functioning of elderly subjects with knee osteoarthritis . However , more rigorous trials are needed to confirm the efficacy of this training for patients with osteoarthritis of the knee",
"This study examines and compares the effect of aerobic and resistance exercise on emotional and physical function among older persons with initially high or low depressive symptomatology . Data are from the Fitness , Arthritis and Seniors Trial , a trial among 439 persons 60 years or older with knee osteoarthritis r and omized to health education ( control ) , resistance exercise , or aerobic exercise groups . Depressive symptoms ( assessed by the Center for Epidemiologic Studies --Depression scale ) and physical function ( disability , walking speed , and pain ) were assessed at baseline and after 3 , 9 , and 18 months . Compared with results for the control group , aerobic exercise significantly lowered depressive symptoms over time . No such effect was observed for resistance exercise . The reduction in depressive symptoms with aerobic exercise was found both among the 98 participants with initially high depressive symptomatology and among the 340 participants with initially low depressive symptomatology and was the strongest for the most compliant persons . Aerobic and resistance exercise significantly reduced disability and pain and increased walking speed both , and to an equal extent , in persons with high depressive symptomatology and persons with low depressive symptomatology",
"Background Prescription of resistance training ( RT ) exercises is an essential aspect of management for knee osteoarthritis ( OA ) . However , whether patients with knee OA who are r and omly assigned to receive RT simply substitute RT for other modes of physical activity remains unclear . Objective The aim of this study was to determine the effect of a structured RT intervention on overall levels of moderate- and vigorous-intensity physical activity ( MVPA ) in patients with early-onset knee OA . The study compared patients with early-onset OA who participated in an RT program , those who participated in a self-management ( SM ) program , and those who participated in both RT and SM . Because participants r and omly assigned to receive the RT intervention may simply switch activity modes , result ing in little net effect , we assessed total MVPA in addition to tracking changes in strength ( force-generating capacity ) . Design and Intervention This study was a r and omized controlled trial comparing the effectiveness of SM alone , RT alone , and combined RT+SM on MVPA in patients with early OA of the knee . Setting The study was conducted on a university campus , with patient recruitment from the local community . Participants The participants in this study were 171 patients ( 74 % women , 26 % men ) with knee OA . They had a mean age of 55.1 ( SD=7.1 ) years , a mean body mass index of 27.6 ( SD=4.2 ) kg/m2 , and radiographic status of grade II OA ( and no higher ) in at least one knee , as defined by the Kellgren and Lawrence classification . They wore an accelerometer while awake ( X̄=14.2 [ SD=2.2 ] hours ) for 5 to 7 contiguous days ( X̄=6.8 [ SD=0.5 ] days ) at baseline and at 3 and 9 months of intervention . Results The participants engaged in MVPA a mean of 26.2 ( SD=19.3 ) minutes per day at baseline . Both groups significantly increased their MVPA from baseline to 3 months ( RT group by 18 % [ effect size (d)=0.26 ] ; SM group by 22 % [ effect size (d)=0.25 ] ) , but only the RT group sustained those changes at 9 months ( RT group maintained a 10 % increase [ effect size (d)=0.15 ] ; SM group maintained a 2 % increase [ effect size (d)=0.03 ] ) . A significant group × time interaction for MVPA indicated that the RT group maintained higher MVPA levels than the SM group . Limitations . Lack of direct measures of energy expenditure and physical function was a limitation of the study . Conclusions Patients with early-onset OA of the knee can engage in an RT program without sacrificing their overall MVPA levels . These results support the value of RT for management of knee OA",
"Background and Purpose : Muscle strength training is important for people with knee osteoarthritis ( OA ) . High-resistance exercise has been demonstrated to be more beneficial than low-resistance exercise for young subjects . The purpose of this study was to compare the effects of high- and low-resistance strength training in elderly subjects with knee OA . Subjects and Methods : One hundred two subjects were r and omly assigned to groups that received 8 weeks of high-resistance exercise ( HR group ) , 8 weeks of low-resistance exercise ( LR group ) , or no exercise ( control group ) . Pain , function , walking time , and muscle torque were examined before and after intervention . Results : Significant improvement for all measures was observed in both exercise groups . There was no significant difference in any measures between HR and LR groups . However , based on effect size between exercise and control groups , the HR group improved more than the LR group . Discussion and Conclusion : Both high- and low-resistance strength training significantly improved clinical effects in this study . The effects of high-resistance strength training appear to be larger than those of low-resistance strength training for people with mild to moderate knee OA , although the differences between the HR and LR groups were not statistically significant",
"OBJECTIVE To determine the effects of structured exercise programs on self-reported disability in older adults with knee osteoarthritis . SETTING AND DESIGN A r and omized , single-blind clinical trial lasting 18 months conducted at 2 academic medical centers . PARTICIPANTS A total of 439 community-dwelling adults , aged 60 years or older , with radiographically evident knee osteoarthritis , pain , and self-reported physical disability . INTERVENTIONS An aerobic exercise program , a resistance exercise program , and a health education program . MAIN OUTCOME MEASURES The primary outcome was self-reported disability score ( range , 1 - 5 ) . The secondary outcomes were knee pain score ( range , 1 - 6 ) , performance measures of physical function , x-ray score , aerobic capacity , and knee muscle strength . RESULTS A total of 365 ( 83 % ) participants completed the trial . Overall compliance with the exercise prescription was 68 % in the aerobic training group and 70 % in the resistance training group . Postr and omization , participants in the aerobic exercise group had a 10 % lower adjusted mean ( + /- SE ) score on the physical disability question naire ( 1.71 + /- 0.03 vs 1.90 + /- 0.04 units ; P knee pain question naire ( 2.1 + /- 0.05 vs 2.4 + /- 0.05 units ; P=.001 ) , and performed better ( mean [ + /- SE ] ) on the 6-minute walk test ( 1507 + /- 16 vs 1349 + /- 16 ft ; P time to climb and descend stairs ( 12.7 + /- 0.4 vs 13.9 + /- 0.4 seconds ; P=.05 ) , time to lift and carry 10 pounds ( 9.1 + /- 0.2 vs 10.0 + /- 0.1 seconds ; P time to get in and out of a car ( 8.7 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P resistance exercise group had an 8 % lower score on the physical disability question naire ( 1.74 + /- 0.04 vs 1.90 + /- 0.03 units ; P=.003 ) , 8 % lower pain score ( 2.2 + /- 0.06 vs 2.4 + /- 0.05 units ; P=.02 ) , greater distance on the 6-minute walk ( 1406 + /- 17 vs 1349 + /- 16 ft ; P=.02 ) , faster times on the lifting and carrying task ( 9.3 + /- 0.1 vs 10.0 + /- 0.16 seconds ; P=.001 ) , and the car task ( 9.0 + /- 0.3 vs 10.6 + /- 0.3 seconds ; P=.003 ) than the health education group . There were no differences in x-ray scores between either exercise group and the health education group . CONCLUSIONS Older disabled persons with osteoarthritis of the knee had modest improvements in measures of disability , physical performance , and pain from participating in either an aerobic or a resistance exercise program . These data suggest that exercise should be prescribed as part of the treatment for knee osteoarthritis",
"Background : According to a recent meta analysis study , there is strong evidence to support the view that transcutaneous electrical nerve stimulation ( TENS ) is an effective treatment for managing osteoarthritis ( OA ) knee pain . However , there is limited evidence showing its effectiveness in improving physical function . This study examined whether TENS alone can improve physical function in terms of range of knee motion and the Timed-Up- and -Go Test . Methods : Subjects were r and omly allocated into 2 groups receiving TENS at 100 Hz or a placebo TENS . Outcome measures included : 1 ) visual analog scale for measuring the intensity of the present pain , 2 ) Timed-Up- and -Go Test , and 3 ) range of knee motion ( ROM ) . Repeated- measures analysis of variance and Pearson correlation were used for data analyses . Results : By day 10 , TENS produced a significantly greater increase in maximum knee ROM than the placebo group ( P = 0.033 ) . TENS also significantly increased the pain-limited knee ROM across sessions , but the between-group difference was short of significance ( P = 0.067 ) . The decrease in time in performing the Timed-Up- and -Go Test was also not significantly different between the 2 groups . A moderate correlation was observed between the reduction in pain scores and the improvement in the Timed-Up- and -Go Test . Conclusions : Our findings suggested that TENS did improve some of the physical parameters but over 10 days was unable to produce significant improvement in functional performance among people with knee OA . A larger-scale study with the assessment of other functional outcomes may be required to clarify if TENS could improve function in people with knee OA . Also , exercise can be considered to be an important adjunct treatment to TENS to improve function significantly",
"OBJECTIVES To determine whether a home-based pedometer-driven walking program with arthritis self-management education ( Walk + ) would increase physical activity , muscle strength , and functional performance in older adults with osteoarthritis ( OA ) of the knee as opposed to arthritis self-management education alone ( EDU ) . DESIGN A r and omized two-by-three ( group-by-time ) design with participants assigned to Walk + ( n = 17 , mean age + /- st and ard deviation = 69.6 + /- 6.7 ) or EDU ( n = 17 , age = 70.8 + /- 4.7 ) . SETTING Community located in the Baltimore-Washington area . PARTICIPANTS Thirty-four community-dwelling adults , aged 60 and older with symptomatic knee OA and self-reported functional impairment . INTERVENTIONS Both groups received 12 hours of the Arthritis Self-Management program over 12 weeks and were followed for an additional 12 weeks . In addition , the Walk + group received individualized instruction in the use of a pedometer , with the goal of increasing their step count by 30 % of their baseline step count . MEASUREMENTS The outcome measures were physical activity ( daily step counts and total activity vector magnitude as measured by a pedometer and Tritrac-R3D accelerometer ) , quadriceps femoris strength ( isometric peak torque ) , and functional performance tasks ( 100-foot walk-turn-walk , timed stair climb , timed chair rise , and pain status ) . RESULTS Daily steps walked showed a significant group-by-time interaction ( P = .04 ) after controlling for age . From baseline to completion of training , a 23 % increase in daily steps occurred in the Walk + group and a 15 % decrease in the EDU group . Although steps increased in the Walk + group , total activity vector magnitude was maintained , suggesting a more efficient gait . The Walk + group became quicker than the EDU group in the normal-pace walk-turn-walk ( P = .04 ) . An isometric strength gain of 21 % postintervention was seen in the Walk + group , compared with a loss of 3.5 % in the EDU group . CONCLUSION In older adults with symptomatic knee OA , Walk + appears to increase walking , with improvements in muscle strength and walking performance . The use of a home-based pedometer-driven program to increase physical activity , strength , and function in this population warrants further research",
"OBJECTIVE This is a double blind study that examined the optimal stimulation frequency of transcutaneous electrical nerve stimulation in reducing pain due to knee osteoarthritis . SUBJECTS Thirty-four subjects were r and omly allocated into 4 groups receiving transcutaneous electrical nerve stimulation at either : ( i ) 2 Hz ; ( ii ) 100 Hz ; ( iii ) an alternating frequency of 2 Hz and 100 Hz ( 2/100 Hz ) ; or ( iv ) a placebo transcutaneous electrical nerve stimulation . METHODS Treatment was administered 5 days a week for 2 weeks . The outcome measures included : ( i ) a visual analogue scale ; ( ii ) a timed up- and -go test ; and ( iii ) a range of knee motion . RESULTS The 3 active transcutaneous electrical nerve stimulation groups ( 2 Hz , 100 Hz , 2/100 Hz ) , but not the placebo group , significantly reduced osteoarthritic knee pain across treatment sessions . However , no significant between-group difference was found . Similarly , the 3 active transcutaneous electrical nerve stimulation groups , but not the placebo group , produced significant reductions in the amount of time required to perform the timed up- and -go test , and an increase in the maximum passive knee range of motion . CONCLUSION Our findings suggested that 2 weeks of repeated applications of transcutaneous electrical nerve stimulation at 2 Hz , 100 Hz or 2/100 Hz produced similar treatment effects for people suffering from osteoarthritic knee",
"BACKGROUND AND PURPOSE Manual therapy and exercise have not previously been compared with a home exercise program for patients with osteoarthritis ( OA ) of the knee . The purpose of this study was to compare outcomes between a home-based physical therapy program and a clinical ly based physical therapy program . SUBJECTS One hundred thirty-four subjects with OA of the knee were r and omly assigned to a clinic treatment group ( n=66 ; 61 % female , 39 % male ; mean age [+/-SD]=64+/-10 years ) or a home exercise group ( n=68 , 71 % female , 29 % male ; mean age [+/-SD]=62+/-9 years ) . METHODS Subjects in the clinic treatment group received supervised exercise , individualized manual therapy , and a home exercise program over a 4-week period . Subjects in the home exercise group received the same home exercise program initially , reinforced at a clinic visit 2 weeks later . Measured outcomes were the distance walked in 6 minutes and the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) . RESULTS Both groups showed clinical ly and statistically significant improvements in 6-minute walk distances and WOMAC scores at 4 weeks ; improvements were still evident in both groups at 8 weeks . By 4 weeks , WOMAC scores had improved by 52 % in the clinic treatment group and by 26 % in the home exercise group . Average 6-minute walk distances had improved about 10 % in both groups . At 1 year , both groups were substantially and about equally improved over baseline measurements . Subjects in the clinic treatment group were less likely to be taking medications for their arthritis and were more satisfied with the overall outcome of their rehabilitative treatment compared with subjects in the home exercise group . DISCUSSION AND CONCLUSION Although both groups improved by 1 month , subjects in the clinic treatment group achieved about twice as much improvement in WOMAC scores than subjects who performed similar unsupervised exercises at home . Equivalent maintenance of improvements at 1 year was presumably due to both groups continuing the identical home exercise program . The results indicate that a home exercise program for patients with OA of the knee provides important benefit . Adding a small number of additional clinical visits for the application of manual therapy and supervised exercise adds greater symptomatic relief",
"PURPOSE To determine whether transcutaneous electrical nerve stimulation ( TENS ) and focal knee joint cooling will affect the quadriceps central activation ratio ( CAR ) in patients with tibiofemoral osteoarthritis . METHODS Thirty-three participants with diagnosed tibiofemoral osteoarthritis were r and omly allocated to the 45-min TENS treatment ( six males and four females , 56 + /- 10.1 yr , 174.11 + /- 10.78 cm , 89.34 + /- 21.3 kg ) , the 20-min focal knee joint cooling treatment ( six males and five females , 58 + /- 8.4 yr , 176.41 + /- 8.29 cm , 83.18 + /- 17.97 kg ) , or the control group ( five males and seven females , 54 + /- 9.9 yr , 166.37 + /- 13.07 cm , 92.14 + /- 25.37 kg ) . Volitional quadriceps activation , maximal voluntary isometric contraction , and subjective pain measurements were conducted at baseline and at 20 , 30 , and 45 min . The 20-min focal knee joint cooling intervention consisted of two 1.5-L ice bags to the anterior and posterior aspects of the knee . The TENS group received 45 min of a sensory , biphasic square wave stimulation ( 150-mus phase duration and 150 pps ) from four 2 x 2-inch electrodes positioned around the patella . RESULTS : TENS result ed in a significantly higher percent change in CAR scores compared with control at 20 min ( 6.4 + /- 4.8 vs -3.5 + /- 8 , P = 0.006 ) , 30 min ( 9.7 + /- 10.16 vs -1 + /- 7.9 , P = 0.025 ) , and 45 min ( 11.25 + /- 6.96 vs 0.81 + /- 9.4 , P = 0.029 ) . Focal knee joint cooling result ed in significantly higher percent change scores compared with the control group at 20 min ( 5.75 + /- 7.25 vs -3.5 + /- 8 , P = 0.009 ) and trended to be higher at 45 min ( 9.06 + /- 9.63 vs 0.81 + /- 9.4 , P = 0.098 ) . No significant differences in percent change for CAR were found between the TENS and the focal knee joint cooling group . CONCLUSIONS Both TENS and focal knee joint cooling increased the quadriceps CAR immediately after application in participants with tibiofemoral osteoarthritis",
"OBJECTIVE To compare the influence of concomitant heeled footwear when wearing a lateral wedged insole for medial compartment of osteoarthritis ( OA ) of the knee , between everyday walking shoes for outdoor use and socks or flat footwear without a heel for indoor use . DESIGN A total of 227 out patients were prospect ively r and omized and treated with a neutral wedged insole inserted into shoes ( placebo with shoes ; n=45 ) , a wedged insole inserted into shoes ( inserted insole with shoes ; n=45 ) , a sock-type ankle supporter with a wedged insole when wearing socks or flat footwear ( inserted insole without shoes ; n=46 ) , a subtalar strapped insole when wearing shoes ( strapped insole with shoes ; n=45 ) , and the strapped insole with socks or flat footwear ( strapped insole without shoes ; n=46 ) . The Lequesne index of knee OA at week 12 was compared with the baseline in each treatment group . RESULTS Twenty patients withdrew from the study , and the 207 patients who completed the 12-week study were evaluated . At the final assessment , participants wearing the inserted insole without shoes ( P=0.003 ) , the strapped insole with shoes ( P strapped insole without shoes ( P Lequesne index scores in comparison with their baseline assessment s. No significant differences were found in the placebo ( P=0.16 ) or the inserted insole with shoes ( P=0.2 ) groups . CONCLUSION Concomitant heeled footwear may decrease the efficacy of an inserted lateral wedged insole . The optimal usage of a lateral wedged insole for knee OA would be the combination with socks or flat footwear without heels",
"Purpose : The EQ-5D is a brief , multiattribute , preference-based health status measure . This article describes the development of a statistical model for generating US population -based EQ-5D preference weights . Methods : A multistage probability sample was selected from the US adult civilian noninstitutional population . Respondents valued 13 of 243 EQ-5D health states using the time trade-off ( TTO ) method . Data for 12 states were used in econometric modeling . The TTO valuations were linearly transformed to lie on the interval [ −1 , 1 ] . Methods were investigated to account for interaction effects caused by having problems in multiple EQ-5D dimensions . Several alternative model specifications ( eg , pooled least squares , r and om effects ) also were considered . A modified split- sample approach was used to evaluate the predictive accuracy of the models . All statistical analyses took into account the clustering and disproportionate selection probabilities inherent in our sampling design . Results : Our D1 model for the EQ-5D included ordinal terms to capture the effect of departures from perfect health as well as interaction effects . A r and om effects specification of the D1 model yielded a good fit for the observed TTO data , with an overall R2 of 0.38 , a mean absolute error of 0.025 , and 7 prediction errors exceeding 0.05 in absolute magnitude . Conclusions : The D1 model best predicts the values for observed health states . The result ing preference weight estimates represent a significant enhancement of the EQ-5D 's utility for health status assessment and economic analysis in the US",
"OBJECTIVE To examine whether the effects of 12 weeks of quadriceps strengthening on the knee adduction moment , pain , and function in people with medial knee osteoarthritis ( OA ) differ in those with and without varus malalignment . METHODS A single-blind , r and omized controlled trial of 107 community volunteers with medial knee OA was conducted . Participants were stratified according to knee malalignment ( more varus or more neutral ) and then r and omized into either a 12-week supervised home-based quadriceps strengthening group or a control group with no intervention . The primary outcome was the knee adduction moment , measured using 3-dimensional gait analysis . Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index scores ( measuring pain and physical function ) , step test score , stair climb test score , and maximum quadriceps isometric strength . Analyses of covariance were carried out based on intent-to-treat principles . RESULTS Quadriceps strengthening did not significantly alter the knee adduction moment in either the more malaligned or the more neutral group ( unadjusted knee adduction moment 0.12 and 0.05 % Nm/BWxHT , respectively ) . Function did not improve significantly following quadriceps strengthening in either alignment group , but there was a significant improvement in knee pain in the more neutrally aligned group ( P Quadriceps strengthening did not have any significant effect on the knee adduction moment in participants with either more varus or more neutral alignment . The benefits of quadriceps strengthening on pain were more evident in those with more neutral alignment . Knee alignment thus represents a local mechanical factor that can mediate symptomatic outcome from exercise interventions in knee OA",
"OBJECTIVE To examine changes in mobility-related self efficacy following exercise and dietary weight loss interventions in overweight and obese older adults with knee osteoarthritis ( OA ) , and to determine if self efficacy and pain mediate the effects of the interventions on mobility task performance . METHODS The Arthritis , Diet , and Activity Promotion Trial was an 18-month , single-blind , r and omized , controlled trial comparing the effects of exercise alone , dietary weight loss alone , a combination of exercise plus dietary weight loss , and a healthy lifestyle control intervention in the treatment of 316 overweight or obese older adults with symptomatic knee OA . Participants completed measures of stair-climb time and 6-minute walk distance , self efficacy for completing each mobility task , and self-reported pain at baseline , 6 months , and 18 months during the trial . RESULTS Mixed model analyses of covariance of baseline adjusted change in the outcomes demonstrated that the exercise + dietary weight loss intervention produced greater improvements in mobility-related self efficacy ( P = 0.0035 ) , stair climb ( P = 0.0249 ) and 6-minute walk performance ( P = 0.00031 ) , and pain ( P = 0.09 ) when compared with the healthy lifestyle control intervention . Mediation analyses revealed that self efficacy and pain served as partial mediators of the beneficial effect of exercise + dietary weight loss on stair-climb time . CONCLUSION Exercise + dietary weight loss results in improved mobility-related self efficacy ; changes in these task-specific control beliefs and self-reported pain serve as independent partial mediators of the beneficial effect of exercise + dietary weight loss on stair-climb performance",
"Objective : To investigate the effects of a sensorimotor training programme in osteoarthritic patients . Design : R and omized , single-blind , controlled trial . Setting : Kinesiology laboratory at School of Physical Therapy . Participants : A total of 60 patients were r and omly assigned to the training group and the control group . Only 29 patients ( training group , 15 ; control group , 14 ) completed the study . Intervention : The training group underwent a sensorimotor training programme using a sling suspension system complemented by a routine physical therapy . The control group underwent a routine physical therapy . Main measures : Active joint repositioning , functional testings , and self-reported function with the Western Ontario & McMaster Universities Arthritis Index before and after the eight-week intervention . Results : There were significant differences between the two groups with respect to the improvement in proprioception as measured by active joint repositioning ( the changes in the absolute error were 1.9± 1.7 ° , training group versus 0.1 ± 2.8 ° , control group ( P in self-reported functional difficulty ( 33.2 ±35.1 , training group versus 8.0± 10.2 , control group ; P Conclusion : A sensorimotor training using a sling suspension system improved the patients ' proprioception in the knee joints and their self-reported function . Thus , these exercises may serve as an exercise programme for patients with knee osteoarthritis",
"OBJECTIVE To evaluate the benefit of shortwave diathermy ( SWD ) supplemented to an exercise program for knee osteoarthritis ( OA ) in peri-/post-menopausal women . METHODS A double-blind r and omized placebo-controlled equivalence trial was conducted in a university hospital . Participants including 113 women aged 50 - 85 years with primary knee OA were instructed to do regular quadriceps exercise , and r and omized to control ( n=60 ) and treatment ( n=53 ) groups receiving sham SWD and therapeutic SWD , respectively . The treatment being evaluated was continuous SWD , 20 min/session , 3 sessions/week for 3 weeks . The outcomes including Thai Western Ontario and McMaster Universities OA ( WOMAC ) index , 100-m walking speed , stair ascent- and -descent time , global assessment , patient 's satisfaction , and adverse events were assessed at baseline and end of treatment . RESULTS At the end of treatment , both groups had trivial but statistical improvement in all outcomes . Intention-to-treat analysis showed no statistically significant difference between the two groups in all outcomes . Per protocol analysis demonstrated the equivalence in Thai WOMAC total score , as the 95 % confidence interval of difference ( -0.62 , 0.92 ) was within confidence limits of + /-1 cm . CONCLUSION The addition of SWD to an exercise program for knee OA in peri-/post-menopausal women is not superior to the exercise program alone",
"OBJECTIVE To evaluate the effectiveness of Tai Chi in the treatment of knee osteoarthritis ( OA ) symptoms . METHODS We conducted a prospect i ve , single-blind , r and omized controlled trial of 40 individuals with symptomatic tibiofemoral OA . Patients were r and omly assigned to 60 minutes of Tai Chi ( 10 modified forms from classic Yang style ) or attention control ( wellness education and stretching ) twice weekly for 12 weeks . The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain score at 12 weeks . Secondary outcomes included WOMAC function , patient and physician global assessment s , timed chair st and , depression index , self-efficacy scale , and quality of life . We repeated these assessment s at 24 and 48 weeks . Analyses were compared by intent-to-treat principles . RESULTS The 40 patients had a mean age of 65 years and a mean body mass index of 30.0 kg/m(2 ) . Compared with the controls , patients assigned to Tai Chi exhibited significantly greater improvement in WOMAC pain ( mean difference at 12 weeks -118.80 mm [ 95 % confidence interval ( 95 % CI ) -183.66 , -53.94 ; P = 0.0005 ] ) , WOMAC physical function ( -324.60 mm [ 95 % CI -513.98 , -135.22 ; P = 0.001 ] ) , patient global visual analog scale ( VAS ; -2.15 cm [ 95 % CI -3.82 , -0.49 ; P = 0.01 ] ) , physician global VAS ( -1.71 cm [ 95 % CI -2.75 , -0.66 ; P = 0.002 ] ) , chair st and time ( -10.88 seconds [ 95 % CI -15.91 , -5.84 ; P = 0.00005 ] ) , Center for Epidemiologic Studies Depression Scale ( -6.70 [ 95 % CI -11.63 , -1.77 ; P = 0.009 ] ) , self-efficacy score ( 0.71 [ 95 % CI 0.03 , 1.39 ; P = 0.04 ] ) , and Short Form 36 physical component summary ( 7.43 [ 95 % CI 2.50 , 12.36 ; P = 0.004 ] ) . No severe adverse events were observed . CONCLUSION Tai Chi reduces pain and improves physical function , self-efficacy , depression , and health-related quality of life for knee OA",
"Objective : To evaluate the cumulative effect of repeated transcutaneous electrical nerve stimulation ( TENS ) on chronic osteoarthritic ( OA ) knee pain over a four-week treatment period , comparing it to that of placebo stimulation and exercise training given alone or in combination with TENS . Design : Sixty-two patients , aged 50–75 , were stratified according to age , gender and body mass ratio before being r and omly assigned to four groups . Interventions : Patients received either ( 1 ) 60 minutes of TENS , ( 2 ) 60 minutes of placebo stimulation , ( 3 ) isometric exercise training , or ( 4 ) TENS and exercise ( TENS & Ex ) five days a week for four weeks . Main outcome measures : Visual analogue scale ( VAS ) was used to measure knee pain intensity before and after each treatment session over a four-week period , and at the four-week follow-up session . Results : Repeated measures ANOVA showed a significant cumulative reduction in the VAS scores across the four treatment sessions ( session 1 , 10 , 20 and the follow-up ) in the TENS group ( 45.9 % by session 20 , p placebo group ( 43.3 % by session 20 , p = 0.034 ) . However , linear regression of the daily recordings of the VAS indicated that the slope in the TENS group ( slope = -2.415 , r = 0.943 ) was similar to the exercise group ( slope = -2.625 , r = 0.935 ) , which were steeper than the other two groups . Note that the reduction of OA knee pain was maintained in the TENS group and the TENS & Ex group at the four-week follow-up session , but not in the other two groups . Conclusions : The four treatment protocol s did not show significant between-group difference over the study period . It was interesting to note that isometric exercise training of the quadriceps alone also reduced knee pain towards the end of the treatment period",
"OBJECTIVE To determine whether gains in functioning observed immediately following participation in an 8-week program of supervised fitness walking for patients with knee osteoarthritis were sustained at 1-year followup . METHODS Twenty-nine ( 61.1 % ) of 47 original intervention program patients and 23 ( 51.1 % ) of 45 original control patients were interviewed by telephone at 1-year followup . Patients completed the Arthritis Impact Measurement Scales physical activity , arthritis impact , pain , medication use , and general health perceptions subscales , as well as a separate visual analog pain scale and measures of perceived self-efficacy to cope with arthritis pain and other symptoms . RESULTS Adherence to walking was low , and there were no statistically significant differences between intervention and control patients at one year . CONCLUSIONS The failure of intervention patients to maintain regular walking result ed in loss of functional benefits that were observed at 8 weeks in the original study . Long-term adherence to walking is critical to maintenance of initial gains in functional outcomes",
"BACKGROUND The OARSI St and ing Committee for Clinical Trials Response Criteria Initiative had developed two sets of responder criteria to present the results of changes after treatment in three symptomatic domains ( pain , function , and patient 's global assessment ) as a single variable for clinical trials ( 1 ) . For each domain , a response was defined by both a relative and an absolute change , with different cut-offs with regard to the drug , the route of administration and the OA localization . OBJECTIVE To propose a simplified set of responder criteria with a similar cut-off , whatever the drug , the route or the OA localization . METHODS Data driven approach : ( 1 ) Two data bases were considered : the \" elaboration \" data base with which the formal OARSI sets of responder criteria were elaborated , and the \" revisit \" data base . ( 2 ) Six different scenarios were evaluated : The two formal OARSI sets of criteria ; Four proposed scenarios of simplified sets of criteria . Data from clinical r and omized blinded placebo controlled trials were used to evaluate the performances of the two formal scenarios with two different data bases ( \" elaboration \" versus \" revisit \" ) and those of the four proposed simplified scenarios within the \" revisit \" data base . The placebo effect , active effect , treatment effect , and the required sample arm size to obtain the placebo effect and the active treatment effect observed were the performances evaluated for each of the six scenarios . Experts ' opinion approach : Results were discussed among the participants of the OMERACT VI meeting , who voted to select the definite OMERACT-OARSI set of criteria ( one of the six evaluated scenarios ) . RESULTS Data driven approach : Fourteen trials totaling 1886 OA patients and fifteen studies involving 8164 OA patients were evaluated in the \" elaboration \" and the \" revisit \" data bases respectively . The variability of the performances observed in the \" revisit \" data base when using the different simplified scenarios was similar to that observed between the two data bases ( \" elaboration \" versus \" revisit \" ) when using the formal scenarios . The treatment effect and the required sample arm size were similar for each set of criteria . Experts ' opinion approach : According to the experts , these two previous performances were the most important of an optimal set of responder criteria . They chose the set of criteria considering both pain and function as evaluation domain and requiring an absolute change and a relative change from baseline to define a response , with similar cut-offs whatever the drug , the route of administration or the OA localization . CONCLUSION This data driven and experts ' opinion approach is the basis for proposing an optimal simplified set of responder criteria for OA clinical trials . Other studies , using other sets of OA patients , are required in order to further vali date this proposed OMERACT-OARSI set of criteria",
"This study was design ed to evaluate , by means of a r and omized controlled trial , the effects of a physical activity program incorporating aerobic , strength , and stretching exercises in individuals with osteoarthritis of the knee . We r and omly assigned 137 volunteers ages > /=50 to an experimental group or a control group . The experimental group participated in three 1-hour sessions of supervised exercises per week over a 3-month period . The control participants were instructed to continue their usual daily activities , and they attended 1-hour education sessions twice a month . The effectiveness of the program was evaluated using repeated measurements of parameters related to self-reported health status , physical capacity , and joint tenderness . After 3 months , significantly greater improvements were observed in the experimental group than the control group in terms of : arthritis pain ( p = 0.02 ) , ability to walk and bend ( p = 0.03 ) , aerobic capacity ( p hamstring and low back flexibility ( p = 0.003 ) , quadriceps and hamstring strength ( p perception of changes relating to osteoarthritis of the knee and general condition ( p isokinetic strength of the quadriceps ( all p 's > = = 0.05 ) , joint tenderness ( p = 0.18 ) , and health perception ( p = 0.7 ) . The overall results suggest that this program is effective for older persons with osteoarthritis of the knee and that it could contribute to maintaining their independence and improving their quality of life",
"OBJECTIVE To compare 16 weeks of isometric versus dynamic resistance training versus a control on knee pain and functioning among patients with knee osteoarthritis ( OA ) . DESIGN R and omized clinical trial . SETTING Outpatient setting . PARTICIPANTS A total of 102 volunteer subjects with OA of the knee r and omized to isometric ( n=32 ) and dynamic ( n=35 ) resistance training groups or a control ( n=35 ) . INTERVENTIONS Strength exercises for the legs , 3 times weekly for 16 weeks . Dynamic group : exercises across a functional range of motion ; isometric : exercises at discrete joint angles . MAIN OUTCOME MEASURES The time to descend and ascend a flight of 27 stairs and to get down and up off of the floor . Knee pain was assessed immediately after each functional task . The Western Ontario and McMaster Universities Osteoarthritis Index was used to assess perceived pain , stiffness , and functional ability . RESULTS In the isometric group , time to perform all 4 functional tasks decreased ( P time to descend and ascend stairs decreased by 13 % to 17 % . Both groups decreased knee pain while performing the functional tasks by 28 % to 58 % . Other measures of pain and functioning were significantly and favorably affected in the training groups . The improvements in the 2 training groups as a result of their respective therapies were not significantly different . The control group did not change over the duration of the study . CONCLUSION Dynamic or isometric resistance training improves functional ability and reduces knee joint pain of patients with knee OA",
"OBJECTIVE In uncontrolled studies , a lateral-wedge insole has reduced knee pain in patients with medial knee osteoarthritis ( OA ) . The aim of this study was to test the efficacy of this simple , low-cost intervention for pain in patients with medial knee OA . METHODS We conducted a double-blind , r and omized , crossover trial design ed to detect a small effect of treatment . Participants were at least 50 years of age and had medial joint space narrowing on posteroanterior semiflexed radiographs and scores indicating moderate pain for 2 of the 5 items on the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) pain scale . Participants were r and omized to receive a 5 degrees lateral-wedge insole or a neutral insole for 6 weeks . Following a 4-week washout period , participants crossed over to the other treatment for 6 weeks . Knee pain , the primary outcome , was assessed by the WOMAC pain scale ( visual analog scale version ) . Secondary outcomes included the WOMAC disability subscale , overall knee pain , 50-feet walk time , chair-st and time , and use of medications for knee pain . RESULTS Ninety patients were r and omized . The mean difference in pain between the 2 treatments was 13.8 points on the WOMAC pain scale ( 95 % confidence interval -3.9 , 31.4 [ P=0.13 ] ) . We observed similar small effects for the secondary outcomes . CONCLUSION The effect of treatment with a lateral-wedge insole for knee OA was neither statistically significant nor clinical ly important",
"STUDY DESIGN R and omized clinical trial . OBJECTIVE To investigate the clinical and functional efficacy of 2 different non-weight-bearing exercise regimens , proprioceptive training ( PrT ) versus strength training ( ST ) , for patients with knee osteoarthritis ( OA ) . BACKGROUND Both strength and proprioceptive training are important interventions for individuals with knee OA . The benefits of weight-bearing exercises are generally recognized in the clinical setting . However , exercising in a st and ing or weight-bearing position may aggravate symptoms in patients with knee OA . METHODS AND MEASURES One hundred eight patients were r and omly assigned to the PrT , ST , or no exercise ( control ) group for an 8-week intervention . Both the PrT and ST interventions consisted of non-weight-bearing exercises . Western Ontario and McMaster Universities Osteoarthritis Index-pain ( WOMAC-pain ) and -function scores , walking time on 3 different terrains , knee strength , and absolute knee reposition error were assessed before and after intervention . Data were analyzed using mixed-model ANOVAs . RESULTS Both PrT and ST significantly improved WOMAC-pain and -function score after intervention ( P WOMAC-function scores ( 17.2 points ) and for knee extension strength ( 10.3 - 14.9 Nm ) was greater than the minimally clinical ly important difference for these measurements . The PrT group demonstrated greater improvement in walking time on a spongy surface and knee reposition error than the other 2 groups . No improvements were apparent in the control group . CONCLUSION Both types of non-weight-bearing exercises ( PrT and ST ) significantly improved outcomes in this study . PrT led to greater improvements in proprioceptive function , while ST result ed in a greater increase in knee extensor muscle strength",
"& NA ; This study tested the separate and combined effects of spouse‐assisted pain coping skills training ( SA‐CST ) and exercise training ( ET ) in a sample of patients having persistent osteoarthritic knee pain . Seventy‐two married osteoarthritis ( OA ) patients with persistent knee pain and their spouses were r and omly assigned to : SA‐CST alone , SA‐CST plus ET , ET alone , or st and ard care ( SC ) . Patients in SA‐CST alone , together with their spouses , attended 12 weekly , 2‐h group sessions for training in pain coping and couples skills . Patients in SA‐CST+ET received spouse‐assisted coping skills training and attended 12‐weeks supervised ET . Patients in the ET alone condition received just an exercise program . Data analyses revealed : ( 1 ) physical fitness and strength : the SA‐CST+ET and ET alone groups had significant improvements in physical fitness compared to SA‐CST alone and patients in SA‐CST+ET and ET alone had significant improvements in leg flexion and extension compared to SA‐CST alone and SC , ( 2 ) pain coping : patients in SA‐CST+ET and SA‐CST alone groups had significant improvements in coping attempts compared to ET alone or SC and spouses in SA‐CST+ET rated their partners as showing significant improvements in coping attempts compared to ET alone or SC , and ( 3 ) self‐efficacy : patients in SA‐CST+ET reported significant improvements in self‐efficacy and their spouses rated them as showing significant improvements in self‐efficacy compared to ET alone or SC . Patients receiving SA‐CST+ET who showed increased self‐efficacy were more likely to have improvements in psychological disability . An intervention that combines spouse‐assisted coping skills training and exercise training can improve physical fitness , strength , pain coping , and self‐efficacy in patients suffering from pain due to osteoarthritis",
"OBJECTIVE To determine the feasibility of conducting a r and omized controlled trial assessing the effect of low-intensity pulsed ultrasound ( US ) therapy on cartilage repair in patients with mild to moderate knee osteoarthritis ( OA ) . DESIGN Pilot , double-blinded , r and omized placebo-controlled trial with 2-months follow-up . SETTING Rehabilitation research facility . PARTICIPANTS Adults ( N=27 ; ≥45y ) with grade s 1 or 2 of medial joint space narrowing ( Osteoarthritis Research Society International atlas ) due to knee OA were r and omly allocated to receive active ( n=14 ) or sham ( n=13 ) US therapy . Four participants withdrew for personal reasons . INTERVENTIONS Twenty-four sessions of active ( 20 % duty cycle , 1MHz , average temporal intensity : 0.2W/cm(2 ) , therapeutic dose : 112.5J/cm(2 ) ) or sham ( no sound-head crystal ) US therapy . MAIN OUTCOME MEASURES Success of recruitment and adherence rates were established by a priori criteria . Effect on cartilage repair was assessed by measuring cartilage volume and thickness and scoring cartilage injury , subchondral cyst formation , and bone marrow lesions on magnetic resonance images . RESULTS Patient recruitment and adherence rates were successful . No significant age-adjusted differences were seen between groups in the cartilage repair outcomes . Age-adjusted analyses , including only subjects who attended 20 sessions or more , showed an increase in medial tibia cartilage thickness in the active US therapy group ( 90μm ; 95 % confidence interval , 1 - 200 ; P=.05 ) . CONCLUSIONS Conducting a r and omized controlled trial to assess the effects of US therapy on the cartilage repair in people with mild to moderate knee OA is feasible . However , further pilot studies are needed to determine the optimal US dose and application parameters before design ing a full trial",
"OBJECTIVE The safety and effectiveness of pulsed electrical stimulation was evaluated for the treatment of osteoarthritis ( OA ) of the knee . METHODS A multicenter , double blind , r and omized , placebo controlled trial that enrolled 78 patients with OA of the knee incorporated 3 primary efficacy variables of patients ' pain , patients ' function , and physician global evaluation of patients ' condition , and 6 secondary variables that included duration of morning stiffness , range of motion , knee tenderness , joint swelling , joint circumference , and walking time . Measurements were recorded at baseline and during the 4 week treatment period . RESULTS Patients treated with the active devices showed significantly greater improvement than the placebo group for all primary efficacy variables in comparisons of mean change from baseline to the end of treatment ( p or = 50 % from baseline was demonstrated in at least one primary efficacy variable in 50 % of the active device group , in 2 variables in 32 % , and in all 3 variables in 24 % . In the placebo group improvement of > or = 50 % occurred in 36 % for one , 6 % for 2 , and 6 % for 3 variables . Mean morning stiffness decreased 20 min in the active device group and increased 2 min in the placebo group ( p tenderness , swelling , or walking time . CONCLUSION The improvements in clinical measures for pain and function found in this study suggest that pulsed electrical stimulation is effective for treating OA of the knee . Studies for longterm effects are warranted",
"OBJECTIVE The investigation aim ed at determining the effectiveness of pulsed electromagnetic fields ( PEMF ) in the treatment of osteoarthritis ( OA ) of the knee by conducting a r and omized , double-blind , placebo-controlled clinical trial . DESIGN The trial consisted of 2h daily treatment 5 days per week for 6 weeks in 83 patients with knee OA . Patient evaluations were done at baseline and after 2 and 6 weeks of treatment . A follow-up evaluation was done 6 weeks after treatment . Activities of daily living ( ADL ) , pain and stiffness were evaluated using the Western Ontario and McMaster Universities ( WOMAC ) question naire . RESULTS Within group analysis revealed a significant improvement in ADL , stiffness and pain in the PEMF-treated group at all evaluations . In the control group there was no effect on ADL after 2 weeks and a weak significance was seen after 6 and 12 weeks . Significant effects were seen on pain at all evaluations and on stiffness after 6 and 12 weeks . Between group analysis did not reveal significant improvements over time . Analysis of ADL score for the PEMF-treated group revealed a significant correlation between less improvement and increasing age . Analysis of patients using between group analysis revealed a significant improvement for stiffness on treated knee after 2 weeks , but this effect was not observed for ADL and pain . CONCLUSIONS Applying between group analysis we were unable to demonstrate a beneficial symptomatic effect of PEMF in the treatment of knee OA in all patients . However , in patients there is significant and beneficial effect of treatment related to stiffness",
"A r and omized double blind clinical trial was conducted to determine the effectiveness of ultrasound ( US ) therapy in knee osteoarthritis ( OA ) . Sixty-seven patients ( mean age 54.8 + /-7 ) were r and omized to receive either 1 MHz frequency or 1 watt/cm(2 ) power continuous ultrasound for 5 min ( n = 34 ) or sham US ( n = 33 ) as a placebo . Ten sessions of treatment were applied to the target knee of the patient . A blinded evaluation at baseline and after treatment was made . Primary outcome was pain on movement assessed by visual analog scale ( VAS ) . Secondary outcomes consisted of the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) scores and 50 meters walking time . Both groups showed significant improvements in knee pain on movement . In the treatment group , the improvement in VAS score was statistically and significantly higher ( p Pain reduction averaged 47.76 % in the treatment group ( p = 0.013 ) . Secondary outcomes improved in both groups but reached statistical significance only in the treatment group : p = 0.006 for the mean change in total WOMAC scores and p = 0.041 for 50 meters walking time . Results suggest that therapeutic US is safe and effective treatment modality in pain relief and improvement of functions in patients with knee OA",
"OBJECTIVE Quadriceps weakness is a risk factor for incident knee osteoarthritis ( OA ) . We describe a r and omized controlled trial of effects of lower-extremity strength training on incidence and progression of knee OA . METHODS A total of 221 older adults ( mean age 69 years ) were stratified by sex , presence of radiographic knee OA , and severity of knee pain , and were r and omized to strength training ( ST ) or range-of-motion ( ROM ) exercises . Subjects exercised 3 times per week ( twice at a fitness facility , once at home ) for 12 weeks , followed by transition to home-based exercise after 12 months . Assessment s of isokinetic lower-extremity strength and highly st and ardized knee radiographs were obtained at baseline and 30 months . RESULTS Subjects in both groups lost lower-extremity strength over 30 months ; however , the rate of loss was slower with ST than with ROM . Compared with ROM , ST decreased the mean rate of joint space narrowing ( JSN ) in osteoarthritic knees by 26 % ( P = not significant ) . However , the difference between ST and ROM groups with respect to frequency of knee OA progression in JSN consensus ratings was marginally significant ( 18 % versus 28 % ; P = 0.094 ) . In knees that were radiographically normal at baseline , JSN > 0.50 mm was more common in ST than in ROM ( 34 % versus 19 % ; P = 0.038 ) . Incident JSN was unrelated to exercise adherence or changes in quadriceps strength or knee pain . CONCLUSION The ST group retained more strength and exhibited less frequent progressive JSN over 30 months than the ROM group . The increase in incident JSN > 0.50 mm in ST is unexplained and requires confirmation",
"Background Several forms of conservative treatment have been the focus of many recent studies in knee osteoarthritis ( OA ) . Among these techniques , the application of pulsed shortwave ( PSW ) treatment has been widely used , but the optimal dose and application time have not been well established . Objective The purpose s of this study were : ( 1 ) evaluate the effect of PSW treatment in different doses and ( 2 ) to compare low-dose and high-dose PSW groups with control and placebo groups . Design This was a r and omized clinical trial . Setting The study was conducted in the physical therapy department of 2 large urban hospitals . Patients One hundred twenty-one women ( mean age=60 years , SD=9 ) with a diagnosis of knee OA participated in the study . Intervention and Measurements Participants were distributed r and omly into 4 groups : 35 participants did not receive any treatment ( control group ) , 23 received a placebo treatment , 32 received low-dose PSW treatment ( power of 14.5 W , treatment duration of 19 minutes , and total energy of 17 kJ ) , and 31 received high-dose PSW treatment ( power of 14.5 W , treatment duration of 38 minutes , and total energy of 33 kJ ) . An 11-point numerical pain rating scale and the Knee Osteoarthritis Outcome Score were used to assess pain and function in 3 stages : at initial evaluation ( pretreatment ) , immediately after treatment , and at 12-month follow-up . Results The 4 groups were homogeneous prior to treatment with respect to demographics , pain , and functional scale data . The results demonstrated the short-term effectiveness of the PSW at low and high doses in patients with knee OA . Both treatment groups showed a significant reduction in pain and improvement in function compared with the control and placebo groups ( effect size : range=20.0–23.4 for the low-dose PSW group and range=15.7–16.5 for the high-dose PSW group ) . There were no differences in results between PSW doses , although a low dose of PSW appeared to be more effective in the long term . Limitations These results were achieved without physical exercise , which could have positively influenced the results . Conclusions Pulsed shortwave treatment is an effective method for pain relief and improvement of function and quality of life in the short term in women with knee OA . On the basis of the results , application of PSW treatment is recommended in the female population with knee OA . However , conclusions regarding the 12-month follow-up should be analyzed carefully due to the high dropout rate",
"Osteoarthritis ( OA ) is a common chronic and progressive degenerative joint condition . A major consequence of knee OA is physical disability ; especially difficulty with activities requiring ambulation and transfer , which are necessary to maintain independence and a good quality of life . The purpose s of this study were to determine the efficacy of a muscle exercise program along with education about knee care , and investigate the clinical factors which influence its therapeutic efficacy . A prospect i ve study was carried out among elderly Thai people aged 60 years and over , living in an urban community of the Bangkok metropolitan area around Siriraj Hospital , between October 1997 and September 1999 . The number of elderly people with osteoarthritis of the knee was 392 ( male : female=86:306 ) with a mean age of 67.7+/-6 years . They were interviewed for demographic data and information about their symptoms . The range of the knee movement , quadriceps strength and the six-minute walking distance and a knee X-ray were evaluated . Group exercise was arranged twice a week for 8 weeks for the intervention group only . The results of the study revealed that the quadriceps strength in the intervention group had a tendency to increase and the walking distance was significantly improved especially in the first two months but there was a tendency to decline by the sixth and twelfth month after enrollment . On the other h and , there was no statistically significant difference of both important outcomes for the control group when assessed in the second month . The findings at the sixth and twelfth month after enrollment were that the quadriceps strength was slightly increased but the walking distance was decreased when compared with the initial assessment . An exercise frequency of 12 sessions in two months was sufficient to improve muscle strength and walking distance . Group exercise produces a significant improvement in strength and walking ability , especially in the first two months . Deterioration over time could be due to multiple factors , such as lack of regular exercise , lack of motivation , lack of family support or poor economic status , so we should encourage the elderly to exercise regularly",
"BACKGROUND Knee osteoarthritis is a highly prevalent condition with a significant socioeconomic burden to society . It is known to effect sufferers through pain , loss of function and changes in health related quality of life . Management typically involves pharmacologic and /or exercise based therapy approaches to reduce pain . Previous studies have shown multimodal treatment approaches incorporating manual therapy to be efficacious . The aim of this study is to determine if a manual therapy technique knee protocol can alter the self reported pain experienced by a group of chronic knee osteoarthritis sufferers in a r and omised controlled trial . METHODS 43 participants with a chronic , non-progressive history of osteoarthritic knee pain , aged between 47 and 70 years were r and omly allocated following a screening procedure to an intervention group ( n=26 ; 18 men and 8 women , mean age 56.5 years ) or a control group ( n=17 ; 11 men and 6 women , mean age 54.6 years ) . Participants were matched for present knee pain intensity measured on a visual analogue scale . The intervention consisted of the Macquarie Injury Management Group Knee Protocol whilst the control involved a non-forceful manual contact to the knee followed by interferential therapy set at zero . Participants received three treatments per week for two consecutive weeks with a follow up immediately after the final treatment . Post-treatment Participants completed 11 questions including present knee pain intensity and feedback regarding their response to treatment utilizing a visual analogue scale . Results were analysed using descriptive statistics . RESULTS Prior to the intervention , there was no significant differences in age or present knee pain intensity . Following treatment , the intervention group reported a significant decrease in the present pain severity ( mean 1.9 ) when compared to the control group ( mean 3.1 ) . Response to treatment questions indicated that compared to the control group , the intervention group felt the intervention had helped them ( intervention mean 7.0 ; control mean 3.4 ) , felt it decreased their knee symptoms such as crepitus ( intervention mean 6.0 ; control mean 3.4 ) and improved their knee mobility ( intervention mean 6.4 ; control mean 3.4 ) and their ability to perform general activities ( intervention mean 6.5 ; control mean 3.8 ) . Importantly the MIMG Knee Protocol intervention group reported no adverse reactions during treatment . CONCLUSIONS A short-term manual therapy knee protocol significantly reduced pain suffered by participants with osteoarthritic knee pain and result ed in improvements in self-reported knee function immediately after the end of the 2 week treatment period",
"Swank , AM , Kachelman , JB , Bibeau , W , Quesada , PM , Nyl and , J , Malkani , A , and Topp , RV . Prehabilitation before total knee arthroplasty increases strength and function in older adults with severe osteoarthritis . J Strength Cond Res 25(2 ) : 318 - 325 , 2011-Preparing for the stress of total knee arthroplasty ( TKA ) surgery by exercise training ( prehabilitation ) may improve strength and function before surgery and , if effective , has the potential to contribute to postoperative recovery . Subjects with severe osteoarthritis ( OA ) , pain intractable to medicine and scheduled for TKA were r and omized into a usual care ( UC ) group ( n = 36 ) or usual care and exercise ( UC + EX ) group ( n = 35 ) . The UC group maintained normal daily activities before their TKA . The UC + EX group performed a comprehensive prehabilitation program that included resistance training using b and s , flexibility , and step training at least 3 times per week for 4 - 8 weeks before their TKA in addition to UC . Leg strength ( isokinetic peak torque for knee extension and flexion ) and ability to perform functional tasks ( 6-minute walk , 30 second sit-to-st and repetitions , and the time to ascend and descend 2 flights of stairs ) were assessed before r and omization at baseline ( T1 ) and 1 week before the subject 's TKA ( T2 ) . Repeated- measures analysis of variance indicated a significant group by time interaction ( p 30-second sit-to-st and repetitions , time to ascend the first flight of stairs , and peak torque for knee extension in the surgical knee . Prehabilitation increased leg strength and the ability to perform functional tasks for UC + EX when compared to UC before TKA . Short term ( 4 - 8 weeks ) of prehabilitation was effective for increasing strength and function for individuals with severe OA . The program studied is easily transferred to a home environment , and clinicians working with this population should consider prehabilitation before TKA",
"Background : The aim of this study was to vali date the Knee Society Clinical Rating System ( knee and function scores ) and to compare its responsiveness with that of the Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) and the Medical Outcomes Study Short Form-36 ( SF-36 ) . Methods : Patients were recruited as part of a prospect i ve observational study of the outcomes of primary total knee arthroplasty for the treatment of osteoarthritis in four centers in the United States , six centers in the United Kingdom , and two centers in Australia . Independent research assistants at each site collected the Knee Society clinical data . The WOMAC , SF-36 , patient satisfaction , and demographic data were obtained with self-administered question naires . Results : A total of 862 eligible patients were recruited , and complete preoperative and twelve-month data were available for 697 ( 80.9 % ) of them . The mean age was seventy years ( range , thirty-eight to ninety years ) , and the majority of the patients ( 58.9 % ) were women . Low correlations were found among the items of both the knee and the function score at both assessment times . The Knee Society pain and function scores had moderate-to-strong correlations with the corresponding pain and function domains of the WOMAC and SF-36 ( r = 0.31 to 0.72 ) . Measurement of the st and ardized response mean showed the Knee Society knee score to be more responsive ( st and ardized response mean , 2.2 ) than the WOMAC ( st and ardized response means , 2.0 for pain and 1.4 for function ) and the SF-36 ( st and ardized response means , 1.0 for bodily pain and 1.1 for physical functioning ) . The Knee Society function score was the least responsive measure ( st and ardized response mean , 0.8 ) . Correlation of changes in scores at twelve months with patient reports of satisfaction and improvement in health status showed the WOMAC and SF-36 to be more responsive than the Knee Society scores . Conclusions : There is a poor correlation among the items of the Knee Society Clinical Rating System , but the rating system has adequate convergent construct validity . The WOMAC and SF-36 are more responsive measures of outcome of total knee arthroplasty . As they are less labor-intensive for research ers to use and as use of these instruments removes observer bias from the study design , they are preferable for knee arthroplasty outcome studies",
"The objective of this study was to examine the short- and long-term effects of a home-based , 12-week neuromuscular electrical stimulation ( NMES ) of the quadriceps femoris to decrease arthritis knee pain in older adults with osteoarthritis of the knee . The study sample ( N = 38 ) was r and omly assigned to the NMES treatment plus education group or the arthritis education-only group . Pain was measured in both groups with the McGill Pain Question naire ( MPQ ) at baseline , during the intervention at weeks 4 , 8 , 12 , and at follow-up and with the Arthritis Impact Measurement Scale 2-Pain Subscale ( AIMS 2-PS ) at baseline and week 12 . The NMES Pain Diary ( PD ) was completed 15 minutes before and after each stimulation session . There was a significant 22 % decline in pain 15 minutes after as compared with immediately before each NMES treatment ( p NMES intervention reduced arthritis knee pain 15 minutes after a NMES treatment",
"Objective : To examine the effects of pulsed short-wave diathermy ( PSWD ) , delivered at an intensity sufficient to induce a thermal sensation and at an athermal intensity , in comparison with a placebo short-wave diathermy treatment , on reported pain , stiffness and functional ability and on mobility performance of patients with osteoarthritis of the knee . Design : A placebo-controlled double-blind trial with sequential allocation of patients to different treatment groups . Setting : Outpatient physiotherapy department . Subjects : One hundred and three consecutive patients , mean age 73.7 ( 9 = 6.6 ) years with osteoarthritis of one or both knees for at least three months . Interventions : All participants received three 20-min-long treatments per week for three weeks . One group received PSWD with mean power of 18 W ( thermal effect ) , one group received PSWD with mean power of 1.8 W ( athermal effect ) , and one group received sham short-wave diathermy treatment . Patients were assessed before the initial treatment , immediately following the last treatment , and at a three-month follow-up . Main measures : Outcome measures included the WOMAC Osteoarthritis Index , which assessed reported pain , stiffness , and functional ability , and four measures of mobility performance : Timed Get Up and Go test ( TGUG ) , stair-climbing , stairdescending and a 3-min walk . Results : A difference across time was observed for the pain and stiffness categories of the WOMAC Osteoarthritis Index ( p pulsed short-wave diathermy , as it is utilized in clinical setting s , to be effective in the treatment of osteoarthritis of the knee",
"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",
"OBJECTIVE To evaluate the effects of pulsed shortwave on osteoarthritis of the knee . METHODS A double blinded , r and omised , controlled trial . Thirteen female and 14 male patients with radiographic evidence of knee osteoarthritis were r and omly allocated to either low dose ( 10 W ) , or high dose ( 20 W ) or placebo high frequency pulsed shortwave . Knee radioleucoscintigraphy was performed pre and post treatment as well as objective functional and subjective evaluations . RESULTS There were no significant differences between the groups in the pre and post treatment percentage change for radioleucoscintigraphy ( P > 0.05 ) . Functional and subjective measures also revealed no pre and post treatment differences between the groups ( P > 0.05 ) , except for improved knee range of motion in the placebo group ( P Joint inflammation in knee osteoarthritis , measured using radioleucoscintigraphy , was not altered significantly by pulsed shortwave , therefore this therapeutic modality has little or no anti-inflammatory effect on conditions such as osteoarthritis of the knee",
"In this study , we planned to investigate the effects of pulse electromagnetic field ( PEMF ) on pain relief and functional capacity of patients with knee osteoarthritis ( OA ) . Fifty-five patients with knee OA were included in a r and omized , placebo-controlled study . At the end of the therapy , there was statistically significant improvement in pain scores in both groups ( P significant difference was observed within the groups ( P > 0.05 ) . We observed statistically significant improvement in some of the subgroups of Lequesne index . These are morning stiffness and activities of daily living activities compared to placebo group . However , we could not observe statistically significant differences in total of the scale between two groups ( P > 0.05 ) . Applying between-group analysis , we were unable to demonstrate a beneficial symptomatic effect of PEMF in the treatment of knee OA in all patients . Further studies using different types of magnetic devices , treatment protocol s and patient population s are warranted to confirm the general efficacy of PEMF therapy in OA and other conditions",
"OBJECTIVE To identify changes in joint pain , stiffness , and functional ability in patients with knee osteoarthritis ( OA ) after use of a knee sleeve that prevents loss of body heat by the joint . METHODS Subjects with symptomatic knee OA ( n = 52 ) were r and omized to 2 treatment groups : verum sleeve ( specially fabricated to retain body heat ) or placebo sleeve ( st and ard cotton/elastane sleeve ) . Subjects wore the sleeve over the more painful OA knee for at least 12 hours daily for 4 weeks . Pain , stiffness , and functional impairment ( Western Ontario and McMaster Universities Osteoarthritis Index [ WOMAC ] ) in the index knee were measured at baseline and after 4 weeks of wear , after which sleeve use was discontinued . Telephone followup interviews were conducted 2 and 4 weeks later . RESULTS After 4 weeks of sleeve wear , subjects in the active treatment group reported a 16 % decrease in mean WOMAC pain score relative to baseline ( P = 0.001 ) . Those who wore the placebo sleeve reported a 9.7 % decrease from baseline ( P = 0.002 ) . The difference between treatment groups was not statistically significant ( P = 0.12 ) . However , it was found that the 12 subjects who believed correctly that they had received the verum sleeve reported a highly significant decrease in WOMAC pain score ( -27.5 % relative to baseline , P = 0.0001 ) . In comparison , subjects who received the verum sleeve but believed they had received the placebo sleeve exhibited only a marginally significant improvement in pain ( -13.0 % relative to baseline , P = 0.07 ) . In the placebo group , the modest improvement in pain scores appeared unrelated to the subject 's impression of the type of sleeve worn . CONCLUSION This pilot study was insufficiently powered to be a definitive trial of the heat-retaining sleeve . Given the magnitude of changes in knee pain in the active treatment group , heat retention merits further scientific investigation as a treatment modality for patients with knee OA",
"The aim was to assess the self-efficacy and health outcomes of an adopted Arthritis Self-Management Programme ( ASMP ) among osteoarthritic knee sufferers in Hong Kong at 1 year . An experimental study with 95 participants assigned r and omly to the intervention ( n=45 ) or control group ( n=50 ) . Seventy-seven ( 81.1 % ) participants joined at least one out of three follow-ups in the 12 month period . Participants in the intervention group received a 6-week ASMP with an added exercise component in two general clinics . Outcome measures included arthritis self-efficacy ( ASE ) and health outcomes including pain and fatigue rating , self-rated health , daily activities limitation and number of unplanned arthritis-related medical consultations . Mean change ( 12 months minus baseline ) and the effect size of the outcome measures were calculated by Mann – Whitney U test and nQuery Advisor 4.0 . At 12 months , there were significant reductions of current pain ( p=0.0001 ) , pain at night ( p=0.001 ) , pain during walking ( p=0.01 ) and number of unplanned arthritis-related medical consultations ( p=0.03 ) and a significant increase in ASE for pain ( p=0.01 ) and other symptoms ( p=0.02 ) and self-rated health ( p=0.04 ) among the intervention group but not for the control group . However , there were similarities in outcome measures of pain while switching from a sitting to a st and ing position , fatigue rating and physical functional limitation ( p=0.15 ; p=0.22 and p=0.91 , respectively ) for both groups . Our findings add to the evidence that the modified arthritis empowering programme improved perception of control of osteoarthritis and three health outcomes after 12 months of treatment",
"This r and omized , placebo-controlled , double-blind study was design ed to investigate the short-term efficacy of ultrasound therapy in 90 patients with knee osteoarthritis ( OA ) . Patients were r and omly assigned to three groups : group 1 received continuous ultrasound , group 2 received pulsed ultrasound , and group 3 received a ‘ sham ’ ( placebo ) ultrasound for 5 min each session . All treatments were applied once a day for 5 days a week for 2 weeks , i.e. a total treatment duration of 10 days . Compared with baseline , significant improvements were observed in the visual analogue scale pain scores and the Western Ontario and McMaster Universities osteoarthritis index ( WOMAC ) scores in all three groups . The reductions in pain and WOMAC scores were significantly higher in patients treated with pulsed ultrasound than in the placebo group . In conclusion , pulsed ultrasound therapy is a safe and effective treatment modality in patients with knee OA . Further research is required to investigate the long-term efficacy of pulsed ultrasound therapy in knee OA",
"OBJECTIVE To assess the effect of a lateral-wedge insole with elastic strapping of the subtalar joint on the femorotibial angle in patients with varus deformity of the knee . METHODS The efficacy of a wedged insole with subtalar straps and that of a traditional wedged insole shoe insert were compared . Sixty-six female out patients with knee osteoarthritis ( OA ) were r and omized ( according to birth date ) to be treated with either the strapped or the traditional inserted insole . St and ing radiographs with unilateral insole use were used to analyze the femorotibial angles for each patient . In both groups , the baseline and 6-month visual analog scale ( VAS ) scores for subjective knee pain and the Lequesne index scores for knee OA were compared . RESULTS The 61 patients who completed the 6-month study were evaluated . At baseline , there was no significant difference in the femorotibial angle ( P = 0.66 ) and the VAS score ( P = 0.75 ) between the 2 groups . At the 6-month assessment , the 29 subjects wearing the subtalar-strapped insole demonstrated a significantly decreased femorotibial angle ( P VAS scores ( P = 0.001 ) and Lequesne index scores ( P = 0.033 ) compared with their baseline assessment s. These significant differences were not observed in the 32 subjects assigned to the traditional shoe-inserted wedged insole . CONCLUSION These results suggest that an insole with a subtalar strap maintained the valgus correction of the femorotibial angle in patients with varus knee OA for 6 months , indicating longer-term clinical improvement with the strapped insert compared with the traditional insert",
"Background and aims : Physical exercise is associated with a lower risk of disability . The impact of comorbidity on the benefits from physical exercise has not been clearly investigated . Elders with comorbidity may benefit from physical exercise to preserve physical function . Methods : Data are from 435 participants with knee osteoarthritis aged ≥60 years enrolled in the Fitness and Arthritis in Seniors Trial ( FAST ) , who were r and omly assigned to 18-month health educational ( HE ) , weight training ( WT ) , or aerobic exercise ( AE ) interventions . Comorbidity was defined as the presence of osteoarthritis and ≥2 clinical conditions . Percent changes in the 6-minute walk test , self-reported disability and knee pain from baseline to 3- , 9- , and 18-month follow-up visits were analyzed according to comorbidity , using analysis of variance . Significance s were adjusted using the Bonferroni method . Results : Mean age of the sample was 68.7 years . In participants with comorbidity ( n=197 ) , those in the AE intervention showed significant improvement in walking speed , compared to WT and HE groups , since the beginning of follow-up . Subjects with comorbidity in AE and WT groups showed improvement of the disability score at the 3-month follow-up visit compared to those in the HE group . This improvement was maintained at the end of the follow-up by the only AE group compared to the HE one ( p=0.06 ) . In participants with comorbidity , the pain score was improved by the AE intervention . Conclusions : AE and WT interventions improve physical function in individuals with comorbidity . AE improves physical function and knee pain independently of the presence of comorbidity",
"OBJECTIVE To investigate the effects of integrated therapy on the functional status of patients with knee osteoarthritis ( OA ) . METHODS A total of 140 subjects with bilateral knee OA ( Altman grade II ) were r and omized sequentially into 4 groups ( groups I-IV ) . Group I received isokinetic exercises ; group II received isokinetic exercise and pulse ultrasound for periarticular soft tissue pain ; group III received isokinetic exercise , pulse ultrasound , and intraarticular hyaluronan therapy ; and group IV acted as the control group . The therapeutic effects of the interventions were evaluated by changes in Lequesne 's index , knee range of motion , peak muscle torques of knee flexion and extension , and ambulation speed after 8 weeks of treatment and at followup 1 year later . In addition , changes in visual analog scale pain and rates of attrition in each group were also recorded . RESULTS Patients in groups I-III exhibited increased muscle peak torques and significantly reduced pain and disability after treatment and at followup . Groups II and III showed significant improvements in range of motion and ambulation speed after treatment . Group III also showed the greatest increase in walking speed and decrease in disability after treatment and at followup . Both group II and group III had significant gains in muscular strength after treatment and at followup ; group III showed the greatest gains . CONCLUSION An integrated therapy deals with the extra- and intraarticular progressive pathologic changes , and kinesiologic management of OA is suggested for the management of knee OA",
"Abstract Objective : To test the hypothesis that medial taping of the patella reduces the symptoms of osteoarthritis of the knee when the patellofemoral joint is affected . Design : R and omised , single blind , crossover trial of three different forms of taping of the knee joint . Each tape ( medial , lateral , or neutral ) was applied for four days , with three days of no treatment between tape positions . Subjects : 14 patients with established , symptomatic osteoarthritis of the knee and both clinical and radiographic evidence of patellofemoral compartment disease . Main outcome measures : Daily visual analogue scale ratings for pain ; patients ' rating of change with each treatment ; and tape preference . Results - Medical taping of the patella was significantly better than the neutral or lateral taping for pain scores , symptom change , and patient preference . The medical tape result ed in a 25 % reduction in knee pain . Conclusion : Patella taping is a simple , safe , cheap way of providing short term pain relief in patients with osteoarthritis of the patellofemoral joint",
"Background and Purpose : This study was design ed to evaluate the effectiveness of hydrotherapy in subjects with osteoarthritis ( OA ) of the knee compared with subjects with OA of the knee who performed l and -based exercises . Subjects and Methods : Sixty-four subjects with OA of the knee were r and omly assigned to 1 of 2 groups that performed exercises for 18 weeks : a water-based exercise group and a l and -based exercise group . The outcome measures included a visual analog scale ( VAS ) for pain in the previous week , the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , pain during gait assessed by a VAS at rest and immediately following a 50-foot ( 15.24-m ) walk test ( 50FWT ) , walking time measured at fast and comfortable paces during the 50FWT , and the Lequesne Index . Measurements were recorded by a blinded investigator at baseline and at 9 and 18 weeks after initiating the intervention . Results : The 2 groups were homogenous regarding all parameters at baseline . Reductions in pain and improvements in WOMAC and Lequesne index scores were similar between groups . Pain before and after the 50FWT decreased significantly over time in both groups . However , the water-based exercise group experienced a significantly greater decrease in pain than the l and -based exercise group before and after the 50FWT at the week-18 follow-up . Discussion and Conclusion : Both water-based and l and -based exercises reduced knee pain and increased knee function in participants with OA of the knee . Hydrotherapy was superior to l and -based exercise in relieving pain before and after walking during the last follow-up . Water-based exercises are a suitable and effective alternative for the management of OA of the knee",
"Doi T , Akai M , Fujino K , Iwaya T , Kurosawa H , Hayashi K , Marui E : Effect of home exercise of quadriceps on knee osteoarthritis compared with nonsteroidal antiinflammatory drugs : a r and omized controlled trial . Am J Phys Med Rehabil 2008;87:258–269 . Objectives : To examine the effect of home-based exercise on knee osteoarthritis among Japanese in comparison with that of nonsteroidal antiinflammatory drugs ( NSAIDs ) . Design : An open-labeled , r and omized , controlled , multiclinic trial compared home-based quadriceps exercise with NSAIDs . Treatments were basically evaluated after 8 wks and compared with the baseline scores . Outcomes were evaluated with a set of psychometric measurements including the Western Ontario and McMaster Universities Arthritis Index ( WOMAC ) , 36-Item Short-Form Health Survey ( SF-36 ) , Japanese Knee Osteoarthritis Measure ( JKOM ) , and pain with the visual analog scale . Results : A total of 142 patients entered this trial to provide the baseline data . After 21 cases withdrew , the final number analyzed was 121 cases : 63 for the exercise group and 58 for the NSAIDs group . Between these two groups , there was no significant difference in gender , age , body height and weight , body mass index , or each score at baseline . The subjects in both groups showed improvements in all scores at the end of intervention . The difference in improvement rate of each score between the two groups was not statistically significant , though the mean rank score measured with JKOM in the exercise was slightly better than that of the NSAIDs . Conclusions : Home-based exercise using quadriceps strengthening improves knee osteoarthritis no less than NSAIDs",
"OBJECTIVE Two lateral wedged insoles were compared : one with , and the other without , subtalar strapping . METHODS Twenty-one patients ( age 58 - 83 , mean 72 ) with medial knee osteoarthritis ( OA ) were enrolled . Thirty-seven knees in the patients were divided into three groups based on the Kellgren and Lawrence OA grading system ; grade s 2 ( cases=20 ) , 3 ( cases=11 ) , and 4 ( cases=6 ) . The subjects were tested during walking barefoot and during walking with a silicon rubber lateral wedged insole with elevation of 10 mm attached to a barefoot . Gait analysis was performed on a 10 m walkway for each subject under three different walking conditions ; barefoot , wearing a conventional insole , and a subtalar strapping insole . Peak knee varus moment during gait was measured under each condition , and compared between the three conditions and between the OA grade s. RESULTS On the whole ( cases=37 ) , the peak varus moment was significantly reduced by wearing either of the insoles , compared to walking barefoot . The reduction was more obvious with the strapping insole ( -13 % , P conventional insole ( -8 % , P moments were significantly lower with the strapping insole , compared with the conventional insole ( P=0.0048 and 0.005 , respectively ) . However , no significant difference was detected in severe OA patients ( grade 4 ) between the two types of insoles ( P=0.4 ) . CONCLUSIONS Both lateral wedged insoles significantly reduced the peak medial compartment load during gait . The subtalar strapping insole had a greater effect than the conventional insole , particularly in patients with moderate medial knee OA",
"OBJECTIVE To compare the effects of concentric and coupled concentric-eccentric isokinetic resistance training on functional capacity and symptoms of patients with osteoarthrosis ( OA ) of both knees . DESIGN Repeated measures . SETTING A university exercise physiology laboratory . PARTICIPANTS Twenty-three volunteers , ages 41 to 75 years . Patients were r and omly assigned to 3 groups : concentric ( CON , n = 9 ) , concentric-eccentric ( CON-ECC , n = 8) , and nontreatment ( NONTX , n = 6 ) . INTERVENTIONS The CON group performed 12 concentric contractions of each knee extensor and flexor muscles ; the CON-ECC group performed 6 concentric and 6 eccentric contractions of each knee muscle group by using a spectrum of angular velocities ranging from 30 degrees/s to 180 degrees/s with 30 degrees/s intervals , for both sides , 3 days a week for 8 weeks . MAIN OUTCOME MEASURES Functional capacity ( rising from a chair , walking , stair climbing and descending ) and pain during rest and activities , peak torque , and cross-sectional area ( CSA ) of knee muscle groups of subjects were tested before and after training . RESULTS Both training groups showed marked decreases ( P pain scores and increases ( P functional capacity together with increases ( P peak torque and CSA of knee muscles . However , the NONTX group did not display these marked changes after the 8-week period . The results also indicated that concentric-eccentric training has a greater influence on functional capacity , especially stair climbing and descending , than that of concentric training when compared with NONTX group ; however , the improvements in pain measurements were better in the CON group compared with the CON-ECC group after the training . CONCLUSIONS The results suggest that with the isokinetic resistance training used in this study , it is possible to improve functional capacity and decrease pain in patients with OA of the knee . The results also showed that extensive training involving a high number of repetitions and eccentric contractions was safe , effective , and well tolerated for the patients with knee OA",
"BACKGROUND In clinical trials , at the group level , results are usually reported as mean and st and ard deviation of the change in score , which is not meaningful for most readers . OBJECTIVE To determine the minimal clinical ly important improvement ( MCII ) of pain , patient 's global assessment of disease activity , and functional impairment in patients with knee and hip osteoarthritis ( OA ) . METHODS A prospect i ve multicentre 4 week cohort study involving 1362 out patients with knee or hip OA was carried out . Data on assessment of pain and patient 's global assessment , measured on visual analogue scales , and functional impairment , measured on the Western Ontario McMaster Universities Osteoarthritis Index ( WOMAC ) function subscale , were collected at baseline and final visits . Patients assessed their response to treatment on a five point Likert scale at the final visit . An anchoring method based on the patient 's opinion was used . The MCII was estimated in a subgroup of 814 patients ( 603 with knee OA , 211 with hip OA ) . RESULTS For knee and hip OA , MCII for absolute ( and relative ) changes were , respectively , ( a ) -19.9 mm ( -40.8 % ) and -15.3 mm ( -32.0 % ) for pain ; ( b ) -18.3 mm ( -39.0 % ) and -15.2 mm ( -32.6 % ) for patient 's global assessment ; ( c ) -9.1 ( -26.0 % ) and -7.9 ( -21.1 % ) for WOMAC function subscale score . The MCII is affected by the initial degree of severity of the symptoms but not by age , disease duration , or sex . CONCLUSION Using criteria such as MCII in clinical trials would provide meaningful information which would help in interpreting the results by expressing them as a proportion of improved patients",
"Abstract Ten patients with pain due to osteoarthritis of the knee were treated in a double‐blind cross‐over study with two weeks of transcutaneous electrical nerve stimulation ( TENS ) and placebo . There was statistically significant pain relief by TENS and half of the patients chose to continue using TENS for pain control after the test month . However , at one year 's follow‐up , only two patients had sufficient benefit to continue using the device",
"OBJECTIVE To investigate the effects of ultrasound ( US ) in isokinetic muscle strengthening exercises on functional status of patients with knee osteoarthritis ( OA ) . DESIGN Effectiveness of isokinetic muscle strengthening exercises for treatment of periarticular soft tissue disorders was compared with and without pulsed and continuous US . SETTING Outpatient exercise program in a Taiwan medical university hospital . PARTICIPANTS One hundred twenty subjects with bilateral knee OA ( Altman grade II ) . INTERVENTION Subjects were r and omized sequentially into 1 of 4 groups . Group I received isokinetic muscular strengthening exercises , group II received isokinetic exercise and continuous US , group III received isokinetic exercise and pulsed US treatment , and group IV was the control group . MAIN OUTCOME MEASURES Therapeutic effects of isokinetic exercise were evaluated by changes in ambulation speed and the Lequesne index . In addition , changes in knee range of motion ( ROM ) , visual analog scale for pain , and muscle peak torques during knee flexion and extension were compared . Compliance in each group was recorded . RESULTS Each treated group had increased muscle peak torques and significantly reduced pain and disability after treatment and at follow-up . However , only patients in groups II and III had significant improvement in ROM and ambulation speed after treatment . Fewer participants in group III discontinued treatment due to knee pain during exercise . Patients in group III also showed the greatest increase in walking speed and decrease in disability after treatment and at follow-up . Gains in muscular strength in 60 degrees /s angular velocity peak torques were also noted in groups II and III . However , group III showed the greatest muscular strength gains with 180 degrees /s angular velocity peak torques after treatment and follow-up . CONCLUSIONS US treatment could increase the effectiveness of isokinetic exercise for functional improvement of knee OA , and pulsed ultrasound has a greater effect than continuous US",
"Decreases in muscular strength , endurance , and angular velocity have previously been demonstrated in the elderly . Osteoarthritis ( OA ) , especially of the knee , may cause further reductions in these parameters and lead to functional limitations . This study measured the effects of a quantitative progressive exercise muscle rehabilitation program ( QPE ) that was added to a physical therapy ( PT ) program . Forty subjects ( 20 men and 20 women ) with OA of the knees were r and omly selected from a group of volunteers ( N = 437 ) for the 3-month program . Measurements of strength , endurance , angular velocity , and the Jette Functional Status Index were determined before and after 1 , 2 , and 3 months of the program . The QPE program was composed of isometric , isotonic , isotonic with resistance , endurance , and speed contractions prescribed in a progressive sequence . Muscle strength ( 14 % and 29 % ) and endurance ( 38 % and 43 % ) increased significantly ( p walking time and the difficulty and pain experienced during functional activities",
"OBJECTIVE To determine whether home-based neuromuscular electrical stimulation ( NMES ) applied to the quadriceps femoris ( QF ) muscle increases strength , physical activity , and physical performance in older adults with knee osteoarthritis ( OA ) . METHODS Thirty-four adults ( > 60 yrs ) with radiographically confirmed symptomatic knee OA were r and omized to NMES plus education or education only ( EDU ) . The primary outcome was isometric QF peak torque ( PTIso ) , with secondary outcomes of daily step counts , total activity vector magnitude , 100-foot walk-turn-walk , timed stair climb , chair rise , and pain . The NMES group used a portable electrical muscle stimulator 3 days a week for unilateral QF training with incremental increases in the intensity of isometric contraction to 30 - 40 % of maximum over 12 weeks . Both groups received the 12-week Arthritis Self-Management course and were followed an additional 12 weeks . RESULTS The stimulated knee-extensor showed a 9.1 % increase in 120 degrees PTIso compared to a 7 % loss in the EDU group ( time x group interaction for 120 degrees PTIso ; p = 0.04 ) . The chair rise time decreased by 11 % in the NMES group , whereas the EDU group saw a 7 % reduction ( p = 0.01 , time ; p = 0.9 , group ) . Similarly , both groups improved their walk time by approximately 7 % ( p = 0.02 , time ; p = 0.61 group ) . Severity of pain reported following intervention did not differ between groups . CONCLUSION In older adults with knee OA , a home-based NMES protocol appears to be a promising therapy for increasing QF strength in adults with knee OA without exacerbating painful symptoms",
"OBJECTIVE To assess the effect of a program of supervised fitness walking and patient education on functional status , pain , and use of medication in patients with osteoarthritis of the knee . DESIGN An 8-week r and omized , controlled trial . SETTING Inpatient and outpatient services of an orthopedic hospital in an academic medical center . PATIENTS A total of 102 patients with a documented diagnosis of primary osteoarthritis of one or both knees participated in the study . Data were obtained on 47 of 51 intervention patients and 45 of 51 control patients . INTERVENTIONS An 8-week program of supervised fitness walking and patient education or st and ard routine medical care . MEASUREMENTS Patients were evaluated and outcomes assessed before and after the intervention using a 6-minute test of walking distance and scores on the physical activity , arthritis impact , pain , and medication subscales of the Arthritis Impact Measurement Scale ( AIMS ) . RESULTS Patients r and omly assigned to the walking program had a 70-meter increase in walking distance relative to their baseline assessment , which represents an improvement of 18.4 % ( 95 % Cl , 9.8 % to 27.0 % ) . In contrast , controls showed a 17-meter decrease in walking distance relative to their baseline assessment ( P less than 0.001 ) . Improvements in functional status as measured by the AIMS physical activity subscale were also observed in the walking group but not in the control group ( P less than 0.001 ) ; patients assigned to the walking program improved 39 % ( Cl , 15.6 % to 60.4 % ) . Although changes in scores on the arthritis impact subscale were similar in the two groups ( P = 0.093 ) , the walking group experienced a decrease in arthritis pain of 27 % ( Cl , 9.6 % to 41.4 % ) ( P = 0.003 ) . Medication use was less frequent in the walking group than in the control group at the post-test ( P = 0.08 ) . CONCLUSIONS A program of supervised fitness walking and patient education can improve functional status without worsening pain or exacerbating arthritis-related symptoms in patients with osteoarthritis of the knee",
"Objective : To examine if the addition of transcutaneous electrical nerve stimulation ( TENS ) to exercise training would produce better physical outcomes than TENS or exercise alone in people with knee osteoarthritis . Design : Sixty-two subjects were r and omly allocated to four groups . Interventions : Patients received either ( 1 ) TENS , ( 2 ) placebo stimulation , ( 3 ) exercise training , or ( 4 ) TENS and exercise training five days a week for four weeks . Main outcome measures : The isometric peak torque , spatiotemporal gait parameters and range of knee movement were assessed in treatment session1 , session10 and session20 and the four-week follow-up . Results : By session20 , the TENS and exercise group demonstrated an average of 26.6 % cumulative gain in the knee extensor peak torque for the different knee positions ( all p exercise group was greater than that found in the other three groups . The TENS and exercise group also tended to show greater cumulative increase in stride length ( 12.6 % , p-0.006 ) , walking cadence ( 9.3 % , p-0.098 ) and gait velocity ( 22.4 % , p-0.034 ) than the other groups . By session20 , it was the only group that produced a significant increase in the range of knee motion during walking ( 12.0%,p-0.000 ) . The TENS group and the exercise group both demonstrated some improvements in the above physical outcomes , but negligible change was found in the group receiving placebo stimulation ( all p > 0.05 ) . Conclusion : No significant difference was found among the four treatment protocol s , but the addition of TENS to exercise training tended to produce the best overall improvement in physical outcomes in people with knee osteoarthritis",
"OBJECTIVE This study investigated the benefits of the combination of interferential ( IF ) and patterned muscle stimulation in the treatment of osteoarthritis ( OA ) of the knee . DESIGN This was a multi-center , r and omized , single-blind , controlled study with an independent observer . The study r and omized 116 patients with OA of the knee to a test or control group . The test group received 15 min of IF stimulation followed by 20 min of patterned muscle stimulation . The control group received 35 min of low-current transcutaneous electrical nerve stimulation ( TENS ) . Both groups were treated for 8 weeks . Subjects completed question naires at baseline and after 2 , 4 and 8 weeks . Primary outcomes included the pain and physical function subscales of the Western Ontario MacMaster ( WOMAC ) OA Index and Visual Analog Scales ( VAS ) for pain and quality of life . RESULTS Compared to the control group , the test group showed reduced pain and increased function . The test group showed a greater decrease in the WOMAC pain subscale ( P=0.002 ) , function subscale ( P=0.003 ) and stiffness subscale ( P=0.004 ) . More than 70 % of the test group , compared to less than 50 % of the control group , had at least a 20 % reduction in the WOMAC pain subscale . When analyzing only patients who completed the study , the test group had a nominally significant greater decrease in overall pain VAS . No significant between-group differences were observed in incidence of adverse events . CONCLUSIONS In patients with OA of the knee , home-based patterned stimulation appears to be a promising therapy for relieving pain , decreasing stiffness , and increasing function",
"OBJECTIVE To explore the effects of noninvasive interactive neurostimulation used as an adjunct to usual care , on pain and other symptoms in adults with osteoarthritis of the knee . DESIGN R and omized , sham-controlled trial . SETTING A university in the southern United States . SUBJECTS Thirty-seven ( 37 ) adults with knee osteoarthritis ( based on American College of Rheumatology diagnostic criteria ) . INTERVENTIONS Seventeen ( 17 ) noninvasive interactive neurostimulation ( active or sham ) sessions over 8 weeks with a week 12 follow-up . OUTCOME MEASURES Eleven-point numeric rating scale for weekly pain ; Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) , patient global assessment , and Short-Form Health Survey ( SF-36 ) completed at baseline and weeks 4 , 8 , and 12 . RESULTS For the main outcome , pain , the differences between the groups over time did not reach statistical significance ( all p > 0.05 ) . However , a clinical ly important reduction in pain ( defined as a 2-point or 30 % reduction on an 11-point numeric rating scale ) was maintained at week 12 by the active noninvasive interactive neurostimulation group ( 2.17 points , 34.55 % reduction ) but not the sham group ( 1.63 , 26.04 % reduction ) . Pain improved over time in participants regardless of group membership ( numeric rating scale average pain , p = 0.002 ; numeric rating scale worst pain , p WOMAC pain , p WOMAC function , WOMAC stiffness , and WOMAC total score ( all p SF-36 Vitality scale , F ( 3 , 105 ) = 3.54 , p = 0.017 . In addition , the active device group improved on the patient global assessment from baseline to week 8 compared to the sham device group , F ( 1 , 35 ) = 4.025 , p = 0.053 . CONCLUSIONS In this pilot study , clinical ly important reductions in knee pain were maintained at week 12 in the active , but not the sham , noninvasive interactive neurostimulation group . Further study of this noninvasive therapy is warranted",
"OBJECTIVE To estimate minimal clinical ly important differences ( MCID ) of effects measured by the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) in patients with osteoarthritis ( OA ) of the lower extremities undergoing a comprehensive inpatient rehabilitation intervention . METHODS A prospect i ve cohort study assessed patients ' health by the WOMAC at baseline ( entry into the clinic ) and at the 3 month followup , and by a transition question naire asking about the change of \" health in general related to the OA joint \" during that time period . The WOMAC section score differences between the \" equal \" group and the \" slightly better \" and \" slightly worse \" groups result ed in the MCID for improvement and for worsening . RESULTS In total 192 patients were followed up . The MCID for improvement ranged from 0.80 to 1.01 points on the continuous WOMAC numerical rating scale from 0 to 10 , reflecting changes of 17 to 22 % of baseline scores . The MCID for worsening conditions ranged from 0.29 ( 6 % ) to 1.03 points ( 22 % ) . In the transition reply subjectively unchanged patients reported a \" pessimistic bias \" of 0.35 to 0.51 points , except for the stiffness section . Both MCID and pessimistic bias showed regression to the mean and baseline dependency . CONCLUSION The assessment of MCID using the transition method is a heuristic and valid strategy to detect particular rehabilitation effects in patients with OA of the lower extremities with the use of the WOMAC , and it is worth implementing . The size of the MCID and of the systematic bias is comparable to that assessed by other methods and in other therapeutic setting",
"OBJECTIVE Gait biomechanics ( knee adduction moment , center of pressure ) and static alignment were investigated to determine the mechanical effect of foot orthoses in people with medial compartment knee osteoarthritis . DESIGN Repeated measures design in which subjects were exposed to three conditions ( normal footwear , heel wedge and orthosis ) in r and om order . BACKGROUND The knee adduction moment is an indirect measure of medial compartment loading . It was hypothesized that the use of a 5 degrees valgus wedge and 5 degrees valgus modified orthosis would shift the center of pressure laterally during walking , thereby decreasing the adduction moment arm and the adduction moment . METHODS Peak knee adduction moment and center of pressure excursion were obtained in nine subjects with medial compartment knee OA during level walking using an optoelectric system and force plate . Static radiographs were taken in 12 subjects using precision radiographs . RESULTS There was no difference between conditions in static alignment , the peak adduction moment or excursion of the center of pressure in the medial-lateral direction . No relationship was found between the adduction moment and center of pressure excursion in the medial-lateral plane . The displacement of the center of pressure in the anterior-posterior direction , measured relative to the laboratory coordinate system , was decreased with the orthosis compared to the control condition ( P=0.036 ) and this measure was correlated with the adduction moment ( r=0.45 , P=0.019 ) . CONCLUSIONS The proposed mechanism was not supported by the findings . The reduction in the center of pressure excursion in the anterior-posterior direction suggests that foot positioning was altered , possibly to a toe-out position , while subjects wore the orthoses . Based on the current findings , we hypothesize that toe-out positioning may reduce medial joint load . RELEVANCE Knee Osteoarthritis is the most common cause of chronic disability amongst seniors . Developing inexpensive , non-invasive treatment strategies for this large population has potential to impact health care costs , quality of life and clinical outcomes",
"OBJECTIVE To discuss the concepts of the minimal clinical ly important difference ( MCID ) and the smallest detectable difference ( SDD ) and to examine their relation to required sample sizes for future studies using concrete data of the condition-specific Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) and the generic Medical Outcomes Study 36-Item Short Form ( SF-36 ) in patients with osteoarthritis of the lower extremities undergoing a comprehensive inpatient rehabilitation intervention . METHODS SDD and MCID were determined in a prospect i ve study of 122 patients before a comprehensive inpatient rehabilitation intervention and at the 3-month followup . MCID was assessed by the transition method . Required SDD and sample sizes were determined by applying normal approximation and taking into account the calculation of power . RESULTS In the WOMAC sections the SDD and MCID ranged from 0.51 to 1.33 points ( scale 0 to 10 ) , and in the SF-36 sections the SDD and MCID ranged from 2.0 to 7.8 points ( scale 0 to 100 ) . Both question naires showed 2 moderately responsive sections that led to required sample sizes of 40 to 325 per treatment arm for a clinical study with unpaired data or total for paired followup data . CONCLUSION In rehabilitation intervention , effects larger than 12 % of baseline score ( 6 % of maximal score ) can be attained and detected as MCID by the transition method in both the WOMAC and the SF-36 . Effects of this size lead to reasonable sample sizes for future studies lying below n = 300 . The same holds true for moderately responsive question naire sections with effect sizes higher than 0.25 . When design ing studies , assumed effects below the MCID may be detectable but are clinical ly meaningless",
"BACKGROUND Knee osteoarthritis ( OA ) is a painful condition causing disability and muscle weakness . Shortwave diathermy ( SWD ) is one of several physical therapy modalities and used predominantly as a pain reduction modality in the clinical practice . However , the efficacy of SWD in knee OA is still inconclusive . AIM The aim of this study was to determine if SWD increase the effectiveness of isokinetic exercise on pain , function , muscle strength , quality of life and depression in patients with OA . DESIGN This was a r and omised , controlled clinical trial . SETTING Inpatient Physiotherapy Department . POPULATION Forty women aged between 42 and 74 years , with a diagnosis of bilateral primary knee OA . METHODS Patients were sequentially r and omized into two groups . Group 1 ( N.=20 ) received SWD and isokinetic muscular strengthening exercises . Group 2 ( N.=20 ) served as control group and they received isokinetic exercises only . Both of the programs were performed three days a week , for a duration of four weeks , and a total of 12 sessions . Patients were assessed before treatment ( BT ) , after treatment ( AT ) , and at a three-month follow-up ( F ) . Outcome measures included visual analogue scale , Western Ontario and McMaster University Osteoarthritis Index , six minute walking distance , isokinetic muscle testing , Short Form 36 and Beck depression index . RESULTS The patients with OA in each group had significant improvements in pain , disability , depression , walking distance , muscle strength , and quality of life AT and F when compared with their initial status ( P0.05 ) except some isokinetic peak torque measurements ( F-BT scores of extension right 60 ° , 120 ° and flexion right 60 ° ) . CONCLUSION Use of SWD in addition to isokinetic exercise program seems to have no further significant effect in terms of pain , disability , walking distance , muscle strength , quality of life and depression in patients with knee OA . CLINICAL REHABILITATION IMPACT Considering the time and cost of combination therapy is now , the isokinetic exercise program , as it is efficient , may be preferable for the treatment of knee OA , alone",
"This study was design ed to determine whether an 8-week isokinetic muscle-strength-training program improved the functional health status of patients with osteoarthritis of the knee joint . Twenty volunteers with osteoarthritis of the knee joint were r and omly assigned to either an experimental ( n=10 ) or control ( n=10 ) group . The experimental group completed six sets of five maximal contractions three times per week for 8 weeks on a Cybex II dynamometer at 90 degrees per second . Both groups were pre- and posttest for extension and flexion strength of the right and left legs , the 50-foot walk time , range of motion at the knee joint , the Osteoarthritis Screening Index ( OASI ) , and the Arthritis Impact Measurement Scale ( AIMS ) . There was a significant decrease in pain and stiffness , and a significant increase in mobility . There was also a significant decline in arthritis activity in the experimental group as measured by the OASI and AIMS . The experimental group significantly increased in all strength measures , while the control group increased in only right leg flexion and left leg extension across the training period",
"This investigation examined predictors of compliance with exercise therapy in a clinical trial involving older adults with knee osteoarthritis ( OA ) . The study sample was partitioned into tertiles by level of compliance to determine its effect on several clinical outcome measures in the trial ( i.e. , knee pain , difficulty with activities of daily living , and performance-related disability ) . The participants ( N = 439 ) first completed all baseline assessment s and were then r and omly assigned to one of three treatment conditions : health education control , aerobic exercise , or resistance exercise . The two exercise treatments involved a 3-month center-based phase and a 15-month home-based phase . Variables in five categories ( i.e. , demographic , fitness , health-related quality of life , performance-related disability , and prior exercise behavior ) were entered as predictors of attendance and time spent exercising during each session for three different periods of time across the course of the study . Results of these analyses revealed that it was possible to explain more variance for time spent exercising ( approximately 40 % ) during the first 3 months than for attendance ( approximately 10 % ) . Furthermore , once participants completed the first 3 months of their training , prior behavior was the strongest predictor of exercise compliance . In most cases , the regression models accounted anywhere from 26 to 46 % of the variance in attendance or time spent exercising ( 7 of the 8 P values demographic , fitness , psychosocial , and disability-related measures did not predict compliance with any consistency across the various phases of the trial . Analysis of the dose-response data suggest that , in the use of aerobic exercise to deter disability in older people with knee OA , consideration should be given to prescribing frequent bouts of activity ( at least 3 times each week ) of moderate duration ( approximately 35 min )",
"OBJECTIVE To assess the efficacy of a lateral wedge insole with elastic strapping of the subtalar joint for conservative treatment of osteoarthritis ( OA ) of the knee . METHODS The efficacy of a novel insole with elastic subtalar strapping and a traditional shoe insert wedge insole was compared . Ninety female out patients with OA of the knee were treated with wedge insoles for 8 weeks . R and omization was performed according to birth date . St and ing radiographs with unilateral insole use were used to analyze the femorotibial and talar tilt angles for each patient with and without their respective insole . Visual analog scale ( VAS ) score for subjective knee pain at the final assessment was compared with that at baseline in both groups . RESULTS Participants wearing the elastically strapped insole ( n = 46 ) had significantly decreased femorotibial angle ( p 0.0001 ) and talar tilt angle ( p = 0.005 ) and significantly improved VAS pain score ( p = 0.045 ) in comparison with baseline assessment s. These significant differences were not found in the group with the inserted insole ( n = 44 ) . CONCLUSION The novel strapped insole leads to valgus angulation of the talus , result ing in correction of the femorotibial angle in patients with knee OA with varus deformity , and may have a therapeutic effect similar to that of high tibial osteotomy",
"A prospect i ve r and omized clinical trial was conducted on 162 patients of osteoarthritis of knee were included in the study . The patients were divided into two groups- Group A and Group B. The Group A was treated with shortwave diathermy , exercise , naproxen and activity modification and the Group B was treated with shortwave diathermy , exercise and naproxen . Improvement was found more in Group A than Group B after 4th week ( 95 % CI was -2.59 to 6.56 ) . Then it was found that the improvement was gradually increased in Group A than Group B and finally , it was found that there was highly significant improvement in Group A than Group B after 6th week ( 95 % CI was -3.45 to -0.70 ) . This study suggests that activity modification play an important role for the treatment of the patients with osteoarthritis of knee",
"OBJECTIVE To investigate whether weight-bearing ( WB ) exercise enhances functional capacity to a greater extent than nonweight-bearing ( NWB ) exercise in participants with knee osteoarthritis . DESIGN R and omized controlled trial . SETTING Kinesiology laboratory . PARTICIPANTS Participants ( N=106 ) were r and omly assigned to WB exercise , NWB exercise , or a control group ( no exercise ) . INTERVENTION WB exercise and NWB exercise groups underwent an 8-week knee extension-flexion exercise program . MAIN OUTCOME MEASURES Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) function scale , walking speed , muscle torque , and knee reposition error were assessed before and after intervention . RESULTS Equally significant improvements were apparent for all outcomes after WB exercise and NWB exercise , except for reposition error , for which improvement was greater in the WB exercise group . In contrast , there were no improvements in the control group . CONCLUSIONS Simple knee flexion and extension exercises ( WB and NWB ) performed over 8 weeks result ed in significant improvement in the WOMAC function scale and knee strength compared with the control group . NWB exercise alone may be sufficient enough to improve function and muscle strength . The additional benefit of WB exercise was improved position sense , which may enhance complex walking tasks ( walking on figure of 8 route and spongy surface )",
"Objective : To determine whether sensory transcutaneous electrical nerve stimulation ( TENS ) augmented with therapeutic exercise and worn for daily activities for four weeks would alter peak gait kinetics and kinematics , compared with placebo electrical stimulation and exercise , and exercise only . Design : R and omized controlled trial . Setting : Motion analysis laboratory . Subjects : Thirty-six participants with radiographically assessed knee osteoarthritis and volitional quadriceps activation below 90 % were r and omly assigned to electrical stimulation , placebo and comparison ( exercise-only ) groups . Interventions : Participants in all three groups completed a four-week quadriceps strengthening programme directed by an experienced rehabilitation clinician . Active electrical stimulation units and placebo units were worn in the electrical stimulation and placebo groups throughout the rehabilitation sessions as well as during all activities of daily living . Main measures : Peak external knee flexion moment and angle during stance phase were analysed at a comfortable walking speed before and after the intervention . Findings : Comfortable walking speed increased for all groups over time ( TENS 1.16 ± 0.15 versus 1.32 ± 0.16 m/s ; placebo 1.21 ± 0.34 versus 1.3 ± 0.24 m/s ; comparison 1.27 ± 0.18 versus 1.5 ± 0.14 m/s ) , yet no group differences in speed were found . No differences were found for peak flexion moment or angle between groups overtime . Conclusions : TENS in conjunction with therapeutic exercise does not seem to affect peak flexion moment and angle during stance over a four-week period in participants with tibiofemoral osteoarthritis"
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Introduction The Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity ( POSSUM ) model and its Portsmouth ( P-POSSUM ) and colorectal ( CR-POSSUM ) modifications are used extensively to predict and audit post-operative mortality and morbidity . This aim of this systematic review was to assess the predictive value of the POSSUM models in colorectal cancer surgery . Methods Major electronic data bases , including Medline , Embase , Cochrane Library and Pubmed were search ed for original studies published between 1991 and 2010 . Two independent review ers assessed each study against inclusion and exclusion criteria . All data was specific to colorectal cancer surgery . Predictive value was assessed by calculating observed to expected ( O/E ) ratios . Results Nineteen studies were included in final review . The mortality analysis included ten studies ( 4,799 patients ) on POSSUM , 17 studies ( 6,576 patients ) on P-POSSUM and 14 studies ( 5,230 patients ) on CR-POSSUM . Weighted O/E ratios for mortality were 0.31 ( CI 0.31–0.32 ) for POSSUM , 0.90 ( CI 0.88–0.92 ) for P-POSSUM and 0.64 ( CI 0.63–0.65 ) for CR-POSSUM . The morbidity analysis included four studies ( 768 patients ) on POSSUM with a weighted O/E ratio of 0.96 ( CI 0.94–0.98 ) . Conclusions P-POSSUM was the most accurate model for predicting post-operative mortality after colorectal cancer surgery . The original POSSUM model was accurate in predicting post-operative complications
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"Well-known and suitable instruments for surgical audit are the POSSUM and P-POSSUM scoring systems . But these scores have not been well vali date d across the countries . The objective of the present study was to assess the predictive value of scores for colorectal surgery in France . Patients operated on for colorectal malignant or diverticular diseases , whether electively or on emergency basis , within a 4-month period were included in a prospect i ve multicenter study conducted by the French Association for Surgery ( Association Française de Chirurgie , AFC ) . The main outcome measure was postoperative in-hospital mortality . Independent factors leading to death were assessed by multivariate logistic regression analysis ( AFC-index ) . The ratio of expected versus observed deaths was calculated , and the predictive value of the POSSUM and P-POSSUM scores were analyzed by the receiver operating characteristic ( ROC ) curve . A total of 1426 patients were included . The in-hospital death rate was 3.4 % . Four independent preoperative factors ( AFC-index ) have been found : emergency surgery , loss of more than 10 % of weight , neurological disease history , and age > 70 years . POSSUM had a poor predictive value ; it overestimated postoperative death in all cases . P-POSSUM had a good predictive value , except for elective surgery , where it overestimated postoperative death twofold . The predictive value of the AFC-index was also good . It had the same sensitivity and specificity as the P-POSSUM . POSSUM has not been vali date d in France in the field of colorectal surgery . P-POSSUM was as predictive as the AFC-index which is a simpler instrument based on four clinical parameters ( without any mathematical formulas )",
"PURPOSE : The Physiologic and Operative Severity Score for the enUmeration of Mortality and morbidity ( POSSUM ) , Portsmouth revision (p)-POSSUM , and colorectal (Cr)-POSSUM scoring systems were developed as audit tools for comparing outcomes in surgical and colorectal patients on the basis of operative risk assessment . The aim of this study was to evaluate the applicability of these systems to a cohort of colon cancer patients undergoing surgery in the United States . METHODS : POSSUM factors from 890 consecutive patients undergoing major surgical procedures for colon cancer in nine United States hospitals over a two-year period from January 2000 through December 2001 were prospect ively collected . The observed over the expected hospital mortality was compared by means of the POSSUM , p-POSSUM , and Cr-POSSUM scoring systems . The effect of missing data on the utility of this process for outcome assessment was assessed with three methods for data imputation . RESULTS : The number of resections per institution ranged from 13 to 437 . The observed mortality rate ranged from 0.8 percent to 15.4 percent among the institutions , with an overall operative mortality of 2.3 percent . The POSSUM , p-POSSUM , and Cr-POSSUM predicted mortality was 10.7 percent , 11.2 percent , and 4.9 percent , respectively . The POSSUM and p-POSSUM models overpredicted mortality in all institutions ( P observed over expected hospital mortality ratio of > 1 in three institutions . The calculations were unaffected by the various methods of inserting missing data . CONCLUSION : An apparent overprediction of mortality for colon cancer resection was evident with all three POSSUM variants . This implies that a calibration process is required for use of these variants in the United States health care system . Missing data may be treated as normal values without influencing outcome . The Cr-POSSUM appeared to be the most promising audit tool for colorectal cancer surgery ; however , it will require further refinement to provide process control graphs for identification of potential outliers and improvement in the quality of care in the United States",
"The Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity ( POSSUM ) is an objective and appropriate scoring system for risk‐adjusted comparative general surgical audit . This score was devised in the UK and has been used widely , but application of POSSUM to centres outside the UK has been limited , especially in developing countries . This prospect i ve study vali date d its application in a surgical practice with a different population and level of re sources",
"A 1‐year prospect i ve analysis was undertaken of all non‐day‐case general surgery in a district general hospital . Using the Physiological and Operative Severity Score for the en Umeration of Mortality and Morbidity ( POSSUM ) scoring system 3004 patients were assessed . From the predictions of mortality and morbidity so obtained , a quality measure , the ratio of observed to expected numbers of deaths and complications ( O : E ratio ) was determined for each surgeon , both overall and within specialty zones . The present study demonstrates the serious hazard in using ‘ raw ’ uncorrected mortality and morbidity statistics to compare surgeon performance . Mortality rates varied from 1·0 to 4·9 per cent whereas O : E ratios ranged from 0·83 to 1·06 ; morbidity rates varied from 5·3 to 12·6 per cent with O : E ratios 0·86‐1·02 . Great misunderst and ing may result from the publication of surgeon or hospital ‘ league tables ’ . The present study demonstrates a technique that might allow surgeon performance to be monitored adequately and accurately",
"BACKGROUND The Physiological and Operative Severity Score for Enumeration of Mortality and Morbidity ( POSSUM ) scoring system , derived from a heterogeneous population , has been used successfully as an audit tool , but it has appeared to over-predict mortality in low-risk groups for which an alternative system , the Portsmouth predictor equation for mortality ( P-POSSUM ) was design ed and used successfully . In this prospect i ve study , we compared these two equations in predicting death and tested their validity in predicting morbidity and mortality in patients undergoing emergency laparotomy in a tertiary hospital . METHODS Eighty-two patients who underwent emergency laparotomy were included in this study . Actual morbidity and mortality rates were compared with the predicted mortality and morbidity rates using both POSSUM and P-POSSUM equations by linear regression and exponential methods of analysis . RESULTS POSSUM equation significantly over-predicted both morbidity and mortality when linear regression analysis was used , but predicted well when exponential analysis was used . Prediction of mortality by P-POSSUM was good using both linear and exponential analyses , and exponential method was better than linear regression analysis . CONCLUSION P-POSSUM is a better equation than POSSUM in predicting mortality , and exponential method is better than linear regression analysis . Both equations are useful tools for risk-adjusted surgical audit of patients undergoing emergency laparotomy",
"BACKGROUND Postoperative morbidity and mortality from colorectal cancer varies widely across hospitals in the UK . We aim ed to assess whether a newly developed score from the Association of Coloproctology of Great Britain and Irel and ( ACPGBI ) could predict mortality from colorectal cancer surgery as accurately as the Physiology and Operative Severity Score for enUmeration of Mortality and morbidity ( POSSUM ) , Portsmouth POSSUM ( P-POSSUM ) , or the ColoRectal POSSUM ( CR-POSSUM ) . METHODS We analysed prospect ively 618 patients with histologically confirmed colorectal cancer who had surgery to remove primary tumours done by colorectal surgeons or non-colorectal surgeons in a 3-year period . We compared observed mortality with those predicted by the ACPGBI , POSSUM , P-POSSUM , and CR-POSSUM scoring systems using the Hosmer-Lemeshow test and Receiver Operating Characteristic ( ROC ) curve analysis . FINDINGS Between April 1 , 2002 , and May 31 , 2005 , 618 consecutive patients with colorectal cancer had surgery to remove primary tumours . Overall observed 30-day mortality over the 3 years was 10.2 % ( 95 % CI 8.0 - 12.9 ) . Overall predicted mortality ( mean score ) by use of POSSUM was 12.7 % ( 11.7 - 13.7 ) , by use of P-POSSUM was 4.4 % ( 3.4 - 5.4 ) , by use of CR-POSSUM was 9.6 % ( 8.6 - 10.6 ) , and by use of ACPGBI score was 8.1 % ( 7.3 - 8.8 ) . INTERPRETATION POSSUM overpredicted mortality , whereas P-POSSUM underpredicted mortality from colorectal-cancer surgery . CR-POSSUM was a more-accurate predictor of mortality in most analyses than was POSSUM and P-POSSUM . Although CR-POSSUM gave the closest prediction of overall mortality , analyses of subgroups of patients showed that ACPGBI score predicted overall mortality most accurately",
"Introduction POSSUM and its variants Portsmouth POSSUM ( P-POSSUM ) and Colorectal POSSUM ( CR-POSSUM ) equations were derived from a heterogeneous general surgical population , which have been used successfully to provide risk-adjusted operative mortality rates . CR-POSSUM utilises fewer parameters , allowing ease of use . The aim of this study was to predict the mortality outcome in colorectal surgery using these scoring systems compared to the observed mortality and to devise a new scoring system with improved accuracy . Methods The study was conducted prospect ively on all consecutive patients requiring elective and emergency colorectal surgery between April 2002 and May 2005 . The outcome parameter was defined as 30-day mortality . The observed mortality was compared with predicted mortality by the scoring systems . Hosmer and Lemeshow test was used to assess statistical accuracy of POSSUM . Results Eight hundred ninety-nine patients underwent colorectal surgery during the study period . There were 619 elective and 281 emergency patients . Observed 30-day mortality rate was 9 % , compared with predicted mortality rate of 13.5 % with POSSUM , 5 % with P-POSSUM and 9.5 % with CR-POSSUM . Conclusion POSSUM ’s mortality rate was overestimated , while P-POSSUM ’s mortality rate was underestimated . CR-POSSUM , the simplest system of all three , most accurately predicted mortality in our unit",
"BACKGROUND There is a need for an accurate measure of surgical outcomes so that hospitals and surgeons can be compared properly regardless of case mix . POSSUM ( Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity ) uses a physiological score and an operative severity score to calculate risks of mortality and morbidity . In a previous small study it was found that Portsmouth POSSUM ( P-POSSUM ; a modification of the POSSUM system ) provided a more accurate prediction of mortality . METHODS Some 10000 general surgical interventions ( excluding paediatric and day cases ) were studied prospect ively between August 1993 and November 1995 . The POSSUM mortality equation was applied to the full 10000 surgical episodes . The 10000 patients were arranged in chronological order and the first 2500 were used as a training set to produce the modified P-POSSUM predictor equation . This was then applied prospect ively to the remaining 7500 patients arranged chronologically in five groups of 1500 . RESULTS The original POSSUM logistic regression equation for mortality overpredicts the overall risk of death by more than twofold and the risk of death for patients at lowest risk ( 5 per cent or less ) by more than sevenfold . The P-POSSUM equation produced a very close fit with the observed in-hospital mortality . CONCLUSION P-POSSUM provides an accurate method for comparative surgical audit",
"OBJECTIVE The aim was to model vascular surgical outcome in a national study using POSSUM scoring . METHODS One hundred and twenty-one British and Irish surgeons completed data question naires on patients undergoing arterial surgery under their care ( mean 12 patients , range 1 - 49 ) in May/June 1998 . A total of 1480 completed data records were available for logistic regression analysis using P-POSSUM methodology . Information collected included all POSSUM data items plus other factors thought to have a significant bearing on patient outcome : \" extra items \" . The main outcome measures were death and major postoperative complications . The data were checked and inconsistent records were excluded . The remaining 1313 were divided into two sets for analysis . The first \" training \" set was used to obtain logistic regression models that were applied prospect ively to the second \" test \" data set . RESULTS using POSSUM data items alone , it was possible to predict both mortality and morbidity after vascular reconstruction using P-POSSUM analysis . The addition of the \" extra items \" found significant in regression analysis did not significantly improve the accuracy of prediction . It was possible to predict both mortality and morbidity derived from the preoperative physiology components of the POSSUM data items alone . CONCLUSION this study has shown that P-POSSUM methodology can be used to predict outcome after arterial surgery across a range of surgeons in different hospitals and could form the basis of a national outcome audit . It was also possible to obtain accurate models for both mortality and major morbidity from the POSSUM physiology scores alone",
"Purpose Scoring systems to predict mortality from surgery are important tools used to give information to the operator and patient and in the auditing of clinical practice . This study was design ed to vali date the recently developed the Colorectal Physiologic and Operative Severity Score for the Enumeration of Mortality and Morbidity ( CR-POSSUM ) scoring system in a single center for colorectal cancer surgery . We also analyzed whether albumin may have a role in the CR-POSSUM model . Methods We compared this model with two other scoring systems : POSSUM and Portsmouth-POSSUM ( P-POSSUM ) models . In-hospital mortality was used as the outcome , and Hosmer-Lemeshow statistic was used to determine goodness of fit . Results Complete data were collected prospect ively from 304 patients from 1990 to the present . The overall operative mortality was 6.5 percent . Observed to expected ratios were used to compare the scoring systems at a given predicted mortality . The overall observed to expected ratio was 1.25 for CR-POSSUM , 1.59 for P-POSSUM , and 3.37 for POSSUM . The CR-POSSUM model showed a good fit with the data ( Hosmer-Lemeshow statistic , 3.86 ; P = 0.795 ) and the area under the receiver operator curve was 0.74 . After correcting for factors used in the CR-POSSUM , logistic regression showed a significant correlation between albumin and mortality ( P = 0.016 ) . Conclusions We have shown that the CR-POSSUM model is an accurate predictor of outcome for major colorectal surgery . The POSSUM and P-POSSUM models over-predicted mortality . Albumin , which is not a factor included in these three systems , may be an important addition in improving the accuracy of the CR-POSSUM model",
"OBJECTIVE To develop and vali date a new Simplified Acute Physiology Score , the SAPS II , from a large sample of surgical and medical patients , and to provide a method to convert the score to a probability of hospital mortality . DESIGN AND SETTING The SAPS II and the probability of hospital mortality were developed and vali date d using data from consecutive admissions to 137 adult medical and /or surgical intensive care units in 12 countries . PATIENTS The 13,152 patients were r and omly divided into developmental ( 65 % ) and validation ( 35 % ) sample s. Patients younger than 18 years , burn patients , coronary care patients , and cardiac surgery patients were excluded . OUTCOME MEASURE Vital status at hospital discharge . RESULTS The SAPS II includes only 17 variables : 12 physiology variables , age , type of admission ( scheduled surgical , unscheduled surgical , or medical ) , and three underlying disease variables ( acquired immunodeficiency syndrome , metastatic cancer , and hematologic malignancy ) . Goodness-of-fit tests indicated that the model performed well in the developmental sample and vali date d well in an independent sample of patients ( P = .883 and P = .104 in the developmental and validation sample s , respectively ) . The area under the receiver operating characteristic curve was 0.88 in the developmental sample and 0.86 in the validation sample . CONCLUSION The SAPS II , based on a large international sample of patients , provides an estimate of the risk of death without having to specify a primary diagnosis . This is a starting point for future evaluation of the efficiency of intensive care units",
"POSSUM , a Physiological and Operative Severity Score for the enUmeration of Mortality and morbidity , is described . This system has been devised from both a retrospective and prospect i ve analysis and the present paper attempts to vali date it prospect ively . Logistic regression analysis yielded statistically significant equations for both mortality and morbidity ( P morbidity and mortality rates could be defined which could be of value in surgical audit . The scoring system produced assessment s for morbidity and mortality rates which did not significantly differ from observed rates",
"Comparison of outcome after colorectal resection among different surgeons is difficult . Crude rates of morbidity and mortality can be misleading because such rates make no allowance for differences in case mix and fitness of patients . AIM : The aim of this study was to compare outcome among five surgeons by means of the simple , well-vali date d scoring system POSSUM for risk-adjusted analysis . METHODS : A total of 438 patients were studied prospect ively . Each patient underwent colorectal resection by one of the five surgeons . Demographic details , operative procedure , and postoperative course were recorded , and physiologic and operative severity scores were determined . Risk of morbidity and mortality was calculated for each patient . RESULTS : Incidence of morbidity varied sharply among the five surgeons , from 13.6 to 30.6 percent , and the 30-day mortality varied from 4.5 to 6.9 percent . However , application of POSSUM to allow risk-adjusted analysis of the data demonstrated that the incidence of morbidity and mortality predicted by POSSUM based on patients physiologic and operative risks factors was very similar to the observed outcome for each surgeon . CONCLUSION : Direct comparison of individual surgeon 's performance based on crude rates of morbidity and mortality can be misleading . Risk-adjusted analysis allows more meaningful comparison",
"POSSUM and APACHE II scores from 117 consecutive admissions to a high‐dependency unit after major surgery were correlated with 30‐day morbidity and mortality rates . Thirteen patients ( II per cent ) died and 59 ( 50 per cent ) developed a postoperative complication . Receiveroperating characteristic curve analysis showed POSSUM to have good predictive value for mortality ( area under curve 0.75 ) and morbidity ( area under curve 0.82 ) . APACHE II scores had a significantly inferior predictive value for mortality ( area under curve 0.54 ) ( P POSSUM was superior to APACHE II in prediction of mortality in patients admitted to a high‐dependency unit after general surgery . Prediction of postoperative complications by POSSUM is accurate and may be useful for audit"
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Gastric cancer ( GC ) is the fifth malignancy and the third cause of cancer death worldwide , according to the global cancer statistics presented in 2018 . Its definition and staging have been revised in the eight edition of the AJCC/TNM classification , which took effect in 2018 . Novel molecular classifications for GC have been recently established and the process of translating these classifications into clinical practice is ongoing . The cornerstone of GC treatment is surgical , in a context of multimodal therapy . Surgical treatment is being st and ardized , and is evolving according to new anatomical concepts and to the recent technological developments . This is leading to a massive improvement in the use of mini-invasive techniques . Mini-invasive techniques aim to be equivalent to open surgery from an oncologic point of view , with better short-term outcomes . The persecution of better short-term outcomes also includes the optimization of the perioperative management , which is being implemented on large scale according to the enhanced recovery after surgery principles . In the era of precision medicine , multimodal treatment is also evolving . The long-time-awaited results of many trials investigating the role for preoperative and postoperative management have been published , changing the clinical practice . Novel investigations focused both on traditional chemotherapeutic regimens and targeted therapies are currently ongoing . Modern platforms increase the possibility for further st and ardization of the different treatments , promote the use of big data , and open new possibilities for surgical learning . This systematic review in two parts assesses all the current up date s in GC treatment
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"BACKGROUND VEGFR-2 has a role in gastric cancer pathogenesis and progression . We assessed whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel . METHODS This r and omised , placebo-controlled , double-blind , phase 3 trial was done at 170 centres in 27 countries in North and South America , Europe , Asia , and Australia . Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline ) were r and omly assigned with a central ised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15 , plus paclitaxel 80 mg/m(2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle . A permuted block r and omisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used . The primary endpoint was overall survival . Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug . This trial is registered with Clinical Trials.gov , number NCT01170663 , and has been completed ; patients who are still receiving treatment are in the extension phase . FINDINGS Between Dec 23 , 2010 , and Sept 23 , 2012 , 665 patients were r and omly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel . Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median 9·6 months [ 95 % CI 8·5 - 10·8 ] vs 7·4 months [ 95 % CI 6·3 - 8·4 ] , hazard ratio 0·807 [ 95 % CI 0·678 - 0·962 ] ; p=0·017 ) . Grade 3 or higher adverse events that occurred in more than 5 % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel included neutropenia ( 133 [ 41 % ] of 327 vs 62 [ 19 % ] of 329 ) , leucopenia ( 57 [ 17 % ] vs 22 [ 7 % ] ) , hypertension ( 46 [ 14 % ] vs eight [ 2 % ] ) , fatigue ( 39 [ 12 % ] vs 18 [ 5 % ] ) , anaemia ( 30 [ 9 % ] vs 34 [ 10 % ] ) , and abdominal pain ( 20 [ 6 % ] vs 11 [ 3 % ] ) . The incidence of grade 3 or higher febrile neutropenia was low in both groups ( ten [ 3 % ] vs eight [ 2 % ] ) . INTERPRETATION The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new st and ard second-line treatment for patients with advanced gastric cancer . FUNDING Eli Lilly and Company",
"Background sNo confirmatory r and omized controlled trials ( RCTs ) have evaluated the efficacy of laparoscopy-assisted distal gastrectomy ( LADG ) compared with open distal gastrectomy ( ODG ) . We performed an RCT to confirm that LADG is not inferior to ODG in efficacy . Methods We conducted a multi-institutional RCT . Eligibility criteria included histologically proven gastric adenocarcinoma in the middle or lower third of the stomach , clinical stage I tumor . Patients were preoperatively r and omized to ODG or LADG . This study is now in the follow-up stage . The primary endpoint is relapse-free survival ( RFS ) and the primary analysis is planned in 2018 . Here , we compared the surgical outcomes of the two groups . This trial was registered at the UMIN Clinical Trials Registry as UMIN000003319 . Results Between March 2010 and November 2013 , 921 patients ( LADG 462 , ODG 459 ) were enrolled from 33 institutions . Operative time was longer in LADG than in ODG ( median 278 vs. 194 min , p blood loss was smaller ( median 38 vs. 115 ml , p overall proportion with in-hospital grade 3–4 surgical complications ( 3.3 % : LADG , 3.7 % : ODG ) . The proportion of patients with elevated serum AST/ALT was higher in LADG than in ODG ( 16.4 vs. 5.3 % , p no operation-related death in either arm . Conclusions This trial confirmed that LADG was as safe as ODG in terms of adverse events and short-term clinical outcomes . LADG may be an alternative procedure in clinical IA/IB gastric cancer if the noninferiority of LADG in terms of RFS is confirmed",
"OBJECTIVE To determine the safety of laparoscopy-assisted distal gastrectomy ( LADG ) compared with open distal gastrectomy ( ODG ) in patients with clinical stage I gastric cancer in Korea . BACKGROUND There is still a lack of large-scale , multicenter r and omized trials regarding the safety of LADG . METHODS A large-scale , phase 3 , multicenter , prospect i ve r and omized controlled trial was conducted . The primary end point was 5-year overall survival . Morbidity within 30 postoperative days and surgical mortality were compared to evaluate the safety of LADG as a secondary end point RESULTS : A total of 1416 patients were r and omly assigned to the LADG group ( n = 705 ) or the ODG group ( n = 711 ) between February 1 , 2006 , and August 31 , 2010 , and 1384 patients were analyzed for modified intention-to-treat analysis ( ITT ) and 1256 were eligible for per protocol ( PP ) analysis ( 644 and 612 , respectively ) . In the PP analysis , 6 patients ( 0.9 % ) needed open conversion in the LADG group . The overall complication rate was significantly lower in the LADG group ( LADG vs ODG ; 13.0 % vs 19.9 % , P = 0.001 ) . In detail , the wound complication rate of the LADG group was significantly lower than that of the ODG group ( 3.1 % vs 7.7 % , P major intra-abdominal complication ( 7.6 % vs 10.3 % , P = 0.095 ) and mortality rates ( 0.6 % vs 0.3 % , P = 0.687 ) were similar between the 2 groups . Modified ITT analysis showed similar results with PP analysis . CONCLUSIONS LADG for patients with clinical stage I gastric cancer is safe and has a benefit of lower occurrence of wound complication compared with conventional ODG",
"Background A dramatic increase in the incidence of the diffuse form of gastric adenocarcinomas and particularly signet ring cell carcinomas has been observed in Western countries . Evidence is accruing that signet ring cell carcinomas may have inherent chemo resistance leaving many clinicians unsure of the benefits of delaying surgery to pursue a neoadjuvant approach . Methods / design PRODIGE-19-FFCD1103-ADCI002 is a prospect i ve multicentre controlled r and omised phase II/III trial comparing current st and ard of care of perioperative chemotherapy ( 2x3 cycles of Epirubicin , cisplatin , 5-fluorouracil ) with a strategy of primary surgery followed by adjuvant chemotherapy ( 6 cycles of Epirubicin , cisplatin , 5-fluorouracil ) in patients with a stage IB-III gastric signet ring cell tumour . The principal objective of the phase II study ( 84 patients ) is to determine if the experimental arm ( primary surgery followed by adjuvant chemotherapy ) has sufficient interest in terms of percentage of living patients at 24 months to be evaluated in a phase III trial . If 7 or less patients in the experimental arm are alive at 24 months , phase III will not be initiated . The primary objective of phase III ( 230 additional patients ) is to demonstrate superiority of the experimental arm in terms of overall survival . Secondary endpoints include overall survival at 36 months , disease free survival at 24 and 36 months , R0 resection rates , treatment tolerance , postoperative mortality and morbidity evaluated by Clavien-Dindo severity index , the prognostic impact of positive peritoneal cytology and the assessment of quality of life . An ancillary study will assess the emotional and cognitive impact of surgery and perioperative chemotherapy for both the patient and their partner . Discussion As inherent chemo resistance of signet ring cell tumours and delay in definitive surgery may favour tumour progression we hypothesise that a policy of primary surgery followed by adjuvant chemotherapy will improve overall survival compared to a st and ard perioperative chemotherapeutic strategy . This r and omised phase II/III trial is the first dedicated to this histological subtype . Whilst the development of new biomarkers and targeted therapies are awaited , the results of this trial should further help in devising individualised protocol s of patient care in a tumour group whose diversity increasingly dem and s assessment of alternative strategies . Trial registration Clinical Trials.gov ,",
"The following treatments show promise but are as yet to be established as st and ard . They should be prospect ively evaluated in appropriate clinical research setting s. Patient consent for investigational treatments should be sought and the rationale behind them given ( Refer to the Sect . 6 ‘ ‘ Commentary on investigational treatments ’ ’ for details ) . The following constitute investigational treatments : – Endoscopic submucosal dissection under exp and ed criteria – Laparoscopic gastrectomy – Local tumor resection – Neoadjuvant chemotherapy – Adjuvant chemotherapy using agents other than S-1 – Neoadjuvant chemoradiotherapy – Adjuvant chemoradiotherapy – Debulking surgery",
"Background The evidence regarding the long-term results of laparoscopic spleen-preserving splenic hilar lymphadenectomy ( LSPL ) has only been rarely reported . The aim of this study was to investigate the feasibility and oncologic efficacy of LSPL for locally advanced proximal gastric cancer . Methods From May 2007 to December 2012 , we prospect ively collected and retrospectively analyzed the data of 548 patients who underwent laparoscopic radical total gastrectomy due to proximal gastric cancer . The patients were grouped according to spleen-preserving splenic hilar lymphadenectomy ( 200 in the D2 group and 348 in the D2-group ) . The short- and long-term outcomes were compared between the two groups after propensity score matching . Results Before matching , TNM stages were significantly different between the D2 and D2-groups . After propensity score matching , the two groups were well balanced in clinicopathologic characteristics . After matching , the time for lymph node dissection was longer in the D2 group , but a greater number of lymph nodes were dissected ; the estimated blood loss , time to first flatus and duration of hospital stay were similar in the two groups . Furthermore , no significant differences in morbidity and mortality were found . Before matching , the 3-year overall survival ( OS ) and disease-free survival ( DFS ) rates of the D2 group were comparable with those of the D2-group ( 62.4 vs. 57.7 % , p = 0.076 ) . After matching , the 3-year OS remained comparable , but the D2 group showed significantly longer 3-year DFS ( 61.6 vs. 53.7 % , p = 0.034 ) . Stratified analysis showed that , in stage III patients , the D2 group had better 3-year DFS . Multivariate Cox regression showed that age ( p = 0.003 ) , operation ( p = 0.001 ) and pN stage ( p LSPL is a safe and feasible procedure , and patients with stage III proximal gastric cancer might obtain higher 3-year DFS rates ",
"Importance Mismatch repair ( MMR ) deficiency ( MMRD ) and microsatellite instability ( MSI ) are prognostic for survival in many cancers and for resistance to fluoropyrimidines in early colon cancer . However , the effect of MMRD and MSI in curatively resected gastric cancer treated with perioperative chemotherapy is unknown . Objective To examine the association among MMRD , MSI , and survival in patients with resectable gastroesophageal cancer r and omized to surgery alone or perioperative epirubicin , cisplatin , and fluorouracil chemotherapy in the Medical Research Council Adjuvant Gastric Infusional Chemotherapy ( MAGIC ) trial . Design , Setting , and Participants This secondary post hoc analysis of the MAGIC trial included participants who were treated with surgery alone or perioperative chemotherapy plus surgery for operable gastroesophageal cancer from July 1 , 1994 , through April 30 , 2002 . Tumor sections were assessed for expression of the MMR proteins mutL homologue 1 , mutS homologue 2 , mutS homologue 6 , and PMS1 homologue 2 . The association among MSI , MMRD , and survival was assessed . Main Outcomes and Measures Interaction between MMRD and MSI status and overall survival ( OS ) . Results Of the 503 study participants , MSI results were available for 303 patients ( 283 with microsatellite stability or low MSI [ median age , 62 years ; 219 males ( 77.4 % ) ] and 20 with high MSI [ median age , 66 years ; 14 males ( 70.0 % ) ] ) . A total of 254 patients had MSI and MMR results available . Patients treated with surgery alone who had high MSI or MMRD had a median OS that was not reached ( 95 % CI , 11.5 months to not reached ) compared with a median OS among those who had neither high MSI nor MMRD of 20.5 months ( 95 % CI , 16.7 - 27.8 months ; hazard ratio , 0.42 ; 95 % CI , 0.15 - 1.15 ; P = .09 ) . In contrast , patients treated with chemotherapy plus surgery who had either high MSI or MMRD had a median OS of 9.6 months ( 95 % CI , 0.1 - 22.5 months ) compared with a median OS among those who were neither high MSI nor MMRD of 19.5 months ( 95 % CI , 15.4 - 35.2 months ; hazard ratio , 2.18 ; 95 % CI , 1.08 - 4.42 ; P = .03 ) . Conclusions and Relevance In the MAGIC trial , MMRD and high MSI were associated with a positive prognostic effect in patients treated with surgery alone and a differentially negative prognostic effect in patients treated with chemotherapy . If independently vali date d , MSI or MMRD determined by preoperative biopsies could be used to select patients for perioperative chemotherapy",
"Background Insufficient attention is paid to the underlying tumor microenvironment ( TME ) evolution , that result ing in tumor heterogeneity and driving differences in cancer aggressiveness and treatment outcomes . The morphological evaluation of the proportion of the stroma at the most invasive part of primary tumor ( tumor-stromal ratio , TSR ) in cancer is gaining momentum as evidence strengthens for the clinical relevance . Methods Tissue sample s from the most invasive part of the primary gastric cancer ( GC ) of 494 patients were analyzed for their TSR , and a new TSNM ( tumor-stromal node metastasis ) staging system based on patho-biological behaviors was established and assessed . Results TSR is a new and strong independent prognostic factor for GC patients . The likelihood of tumor invasion is increased significantly for patients in the stromal-high subgroup compared to those in the stromal-low subgroup ( P = 0.011 ) . The discrimination ability of TSR was not less than the TNM staging system and was better in patients with stages I and II GC . We integrated the TSR parameter into the TNM staging system and proposed a new TSNM staging system creatively . There were three new subgroups ( IC , IIC , IIID ) . There were four major groups and 10 subgroups in the TSNM system . The difference in overall survival ( OS ) was statistically significant among all TSNM system ( P < 0.005 for all ) . Deep analyses revealed well predictive performance of the TSNM ( P < 0.001 ) . Conclusions This study confirms the TSR as a TME prognostic factor for GC . TSR is a c and i date TME parameter that could easily be implemented in routine pathology diagnostics , and the TSNM staging system has been established to optimize risk stratification for GC . The value of the TSNM staging system should be vali date d in further prospect i ve study",
"Background We sought to determine the sites of recurrence and identify predicting factors for recurrence and survival in patients who underwent gastrectomy for adenocarcinoma at an institution where preoperative therapy is commonly used for advanced gastric cancer . Methods We collected clinicopathologic data and sites of recurrence from a prospect ively maintained data base of patients who underwent potentially curative resection of gastric or gastroesophageal adenocarcinoma at our institution in 1995–2014 , and we assessed associations between these characteristics and recurrence patterns and survival . Results We identified 488 patients who underwent R0 resection of localized gastric cancer . The median age was 63 years ( interquartile range 53–71 years ) , and 60 % were male . The most common T and N categories , per endoscopic ultrasonography , were T3 ( 58 % ) and N0 ( 61 % ) . Preoperative treatment was used in 61 % of patients . A total of 125 ( 26 % ) patients experienced recurrence during follow-up . Recurrences were locoregional in 19 patients ( 15 % ) , peritoneal in 61 ( 49 % ) , and nonperitoneal distant in 67 ( 54 % ) . The peritoneum also was the most common organ of recurrence ( 49 % ) , followed by the liver ( 21 % ) . The median time from primary resection to recurrence was 2.7 years for locoregional , 1.3 years for peritoneal , and 0.6 years for nonperitoneal distant recurrence ( p = 0.01 ) . Median overall survival was markedly shorter after peritoneal and nonperitoneal distant recurrences than after locoregional recurrences . Conclusions The peritoneum was a common site of recurrence after curative resection of gastric cancer and was associated with poor survival . Prophylactic treatment targeting the peritoneal cavity might improve survival of advanced gastric cancer",
"Objective : To clarify the role of splenectomy in total gastrectomy for proximal gastric cancer . Background s : Splenectomy in total gastrectomy is associated with increased operative morbidity and mortality , but its survival benefit is unclear . Previous r and omized controlled trials were underpowered and inconclusive . Methods : We conducted a multiinstitutional r and omized controlled trial . Proximal gastric adenocarcinoma of T2 - 4/N0 - 2/M0 not invading the greater curvature was eligible . During the operation , surgeons confirmed that R0 resection was possible with negative lavage cytology , and patients were r and omly assigned to either splenectomy or spleen preservation . The primary endpoint was overall survival ( OS ) and the secondary endpoints were relapse-free survival , operative morbidity , operation time , and blood loss . The trial was design ed to confirm noninferiority of spleen preservation to splenectomy in OS with a noninferiority margin of the hazard ratio as 1.21 and 1-sided alpha of 5 % . Results : Between June 2002 and March 2009 , 505 patients ( 254 splenectomy , 251 spleen preservation ) were enrolled from 36 institutions . Splenectomy was associated with higher morbidity and larger blood loss , but the operation time was similar . The 5-year survivals were 75.1 % and 76.4 % in the splenectomy and spleen preservation groups , respectively . The hazard ratio was 0.88 ( 90.7 % , confidence interval 0.67–1.16 ) ( total gastrectomy for proximal gastric cancer that does not invade the greater curvature , splenectomy should be avoided as it increases operative morbidity without improving survival",
"BACKGROUND Trastuzumab , a monoclonal antibody against human epidermal growth factor receptor 2 ( HER2 ; also known as ERBB2 ) , was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer . METHODS ToGA ( Trastuzumab for Gastric Cancer ) was an open-label , international , phase 3 , r and omised controlled trial undertaken in 122 centres in 24 countries . Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumours showed overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation . Participants were r and omly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous trastuzumab . Allocation was by block r and omisation stratified by Eastern Cooperative Oncology Group performance status , chemotherapy regimen , extent of disease , primary cancer site , and measurability of disease , implemented with a central interactive voice recognition system . The primary endpoint was overall survival in all r and omised patients who received study medication at least once . This trial is registered with Clinical Trials.gov , number NCT01041404 . FINDINGS 594 patients were r and omly assigned to study treatment ( trastuzumab plus chemotherapy , n=298 ; chemotherapy alone , n=296 ) , of whom 584 were included in the primary analysis ( n=294 ; n=290 ) . Median follow-up was 18.6 months ( IQR 11 - 25 ) in the trastuzumab plus chemotherapy group and 17.1 months ( 9 - 25 ) in the chemotherapy alone group . Median overall survival was 13.8 months ( 95 % CI 12 - 16 ) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months ( 10 - 13 ) in those assigned to chemotherapy alone ( hazard ratio 0.74 ; 95 % CI 0.60 - 0.91 ; p=0.0046 ) . The most common adverse events in both groups were nausea ( trastuzumab plus chemotherapy , 197 [ 67 % ] vs chemotherapy alone , 184 [ 63 % ] ) , vomiting ( 147 [ 50 % ] vs 134 [ 46 % ] ) , and neutropenia ( 157 [ 53 % ] vs 165 [ 57 % ] ) . Rates of overall grade 3 or 4 adverse events ( 201 [ 68 % ] vs 198 [ 68 % ] ) and cardiac adverse events ( 17 [ 6 % ] vs 18 [ 6 % ] ) did not differ between groups . INTERPRETATION Trastuzumab in combination with chemotherapy can be considered as a new st and ard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer . FUNDING F Hoffmann-La Roche",
"Background For gastric cancer patients , surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment . Open gastrectomy has long been the preferred surgical approach worldwide . However , this procedure is associated with considerable morbidity . Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures , with similar oncologic outcomes . However , it remains unclear whether the results of these Asian studies can be extrapolated to the Western population . In this trial from the Netherl and s , patients with resectable gastric cancer will be r and omized to laparoscopic or open gastrectomy . Methods The study is a non-blinded , multicenter , prospect ively r and omized controlled superiority trial . Patients ( ≥18 years ) with histologically proven , surgically resectable ( cT1 - 4a , N0 - 3b , M0 ) gastric adenocarcinoma and European Clinical Oncology Group performance status 0 , 1 or 2 are eligible to participate in the study after obtaining informed consent . Patients ( n = 210 ) will be included in one of the ten participating Dutch centers and are r and omized to either laparoscopic or open gastrectomy . The primary outcome is postoperative hospital stay ( days ) . Secondary outcome parameters include postoperative morbidity and mortality , oncologic outcomes , readmissions , quality of life and cost-effectiveness . Discussion In this r and omized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer . It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay . Secondly , it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity , less readmissions , higher cost-effectiveness , better postoperative quality of life , but with similar mortality and oncologic outcomes , compared to open gastrectomy . The study started on 1 December 2014 . Inclusion and follow-up will take 3 and 5 years respectively . Short-term results will be analyzed and published after discharge of the last r and omized patient . Trial registration",
"Background Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases , such as less perioperative blood loss and faster patient recovery . It also maintains similar results with regard to tumor resection margins and oncological long-term survival . In gastric cancer the role of laparoscopic surgery remains unclear . Current recommended treatment for gastric cancer consists of radical resection of the stomach , with a free margin of 5 to 6 cm from the tumor , combined with a lymphadenectomy . The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care . Therefore , it is imperative that a novel surgical technique , such as minimally invasive total gastrectomy , should be non-inferior with regard to radicality of surgery and lymph node yield . Methods / Design The Surgical Techniques , Open versus Minimally invasive gastrectomy After CHemotherapy ( STOMACH ) study is a r and omized , clinical multicenter trial . All adult patients with primary carcinoma of the stomach , in which the tumor is considered surgically resectable ( T1 - 3 , N0 - 1 , M0 ) after neo-adjuvant chemotherapy , are eligible for inclusion and r and omization . The primary endpoint is quality of oncological resection , measured by radicality of surgery and number of retrieved lymph nodes . The pathologist is blinded towards patient allocation . Secondary outcomes include patient-reported outcomes measures ( PROMs ) regarding quality of life , postoperative complications and cost-effectiveness . Based on a non-inferiority model for lymph node yield , with an average lymph node yield of 20 , a non-inferiority margin of −4 and a 90 % power to detect non-inferiority , a total of 168 patients are to be included . Discussion The STOMACH trial is a prospect i ve , multicenter , parallel r and omized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy : the conventional ‘ open ’ approach or minimally invasive total gastrectomy . Trial registration This trial was registered on 28 April 2014 at Clinical trials.gov with the identifier NCT02130726",
"A panel review of histologic specimens was carried out as part of a multi-centre case-control study of gastric cancer ( GC ) and diet . Comparisons of diagnoses of 100 GCs by six pathologists revealed agreement in histologic classification for about 70 - 80 % of the cancers . Concordance was somewhat higher when using the Lauren rather than the Ming or World Health Organization classification systems . Histologic types from reading biopsy tissue agreed with those derived from surgical specimens for 65 - 75 % of the 100 tumours . Intra-observer agreement in histologic classification , assessed by repeat readings up to 3 years apart by one pathologist , was 95 % . The findings indicate that , although overall concordance was good , it is important to st and ardise diagnoses in multi-centre epidemiologic studies of GC by histologic type",
"Abstract Background The efficacy and safety outcomes of laparoscopy-assisted distal gastrectomy ( LADG ) with D2 lymph node dissection for locally advanced gastric cancer remain unclear . Therefore , we conducted a r and omized , controlled phase II trial to confirm the feasibility of LADG in terms of technical safety , and short-term surgical outcomes were investigated . Methods Eligibility criteria included pre-operatively diagnosed advanced gastric cancer that could be treated by distal gastrectomy with D2 lymph node dissection ; MP , SS , and SE without involvement of other organs ; and N0–2 and M0 . Patients aged 20–80 years were pre-operatively r and omized . Results In total , 180 patients were registered and r and omized to the open ( 89 patients ) and laparoscopic arms ( 91 patients ) . Among 91 patients in the laparoscopic arm , 86 underwent laparoscopic gastrectomy according to the study protocol . Regarding the primary endpoint of the phase II trial , the proportion of patients with either anastomotic leakage or pancreatic fistula was 4.7 % ( 4/86 ) . The grade 3 or higher morbidity rate , including systemic and local complications , was 5.8 % . Conversion to open surgery was required for 1 patient ( 1.2 % ) , without any intra-operative complication . The post-operative mortality rate was 0 , and no patient required readmission for surgical complications within 6 months after initial discharge . Conclusions The technical safety of LADG with D2 lymph node dissection for locally advanced gastric cancer was demonstrated . A phase III trial to confirm the non-inferiority of this procedure to open gastrectomy in terms of long-term outcomes is ongoing . Registered Number : UMIN 000003420 ( www.umin.ac.jp/ctr/ )",
"BACKGROUND The role of bursectomy , in which the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon are dissected , has long been controversial for preventing peritoneal metastasis . We investigated the survival benefit of bursectomy in patients with resectable gastric cancer . METHODS This phase 3 , open-label , r and omised controlled trial was done at 57 hospitals in Japan . Patients aged 20 - 80 years who had cT3(SS)-cT4a(SE ) histologically proven gastric adenocarcinoma with an Eastern Cooperative Oncology Group performance status of 0 or 1 and body-mass index less than 30 kg/m2 and who did not have distant metastasis or bulky lymph nodes were r and omly assigned ( 1:1 ) during surgery to receive omentectomy alone ( non-bursectomy ) or bursectomy . R and omisation was done by telephone or website to the Japan Clinical Oncology Group Data Center and used a minimisation method with a r and om component to adjust for institution , cT status ( T3 vs T4a ) , and type of gastrectomy ( distal vs total ) . Both groups had total or distal gastrectomy with D2 lymphadenectomy . The primary endpoint was overall survival , analysed in the intention-to-treat population . The study is registered with UMIN-CTR , number UMIN000003688 . FINDINGS Between June 1 , 2010 , and March 30 , 2015 , 1503 patients were enrolled based on preoperative inclusion and exclusion criteria . Intraoperative inclusion and exclusion criteria were met in 1204 patients , of which 602 were allocated to the non-bursectomy group and 602 were allocated to the bursectomy group . At the planned second interim analysis on Sept 17 , 2016 , the JCOG Data and Safety Monitoring Committee independently review ed the results and recommended their early publication on the basis of futility because overall survival was lower in the bursectomy group than the non-bursectomy group , and because the predictive probability of overall survival being significantly higher in bursectomy than non-bursectomy patients at the final analysis was only 12·7 % . 5-year overall survival was 76·7 % ( 95 % CI 72·0 - 80·6 ) in the non-bursectomy group and 76·9 % ( 72·6 - 80·7 ) in the bursectomy group ( hazard ratio 1·05 , 95 % CI 0·81 - 1·37 , one-sided p=0·65 ) . 64 ( 11 % ) of 601 in the non-bursectomy group and 77 ( 13 % ) of 600 patients in the bursectomy group had grade 3 - 4 operative morbidity . Pancreatic fistula was significantly more common in the bursectomy group than in the non-bursectomy group ( 29 [ 5 % ] vs 15 [ 2 % ] ; p=0·032 ) . Six deaths occurred either in hospital or within 1 month of surgery : five in the non-bursectomy group and one in the bursectomy group . INTERPRETATION Bursectomy did not provide a survival advantage over non-bursectomy . D2 dissection with omentectomy alone should be done as a st and ard surgery for resectable cT3-T4a gastric cancer . FUNDING Japan Agency for Medical Research and Development , the Ministry of Health , Labour and Welfare of Japan , and the National Cancer Centre Research and Development Fund",
"Aim The aim of this study was to determine the oncologic value of omentectomy in patients undergoing gastrectomy for gastric cancer . Methods All consecutive patients with gastric cancer that underwent gastrectomy with curative intent between April 2012 and August 2015 were prospect ively analyzed . The greater omentum was separately marked during operation and pathologically evaluated for the presence of omental lymph nodes and tumor deposits . Results In total , 50 patients were included . The greater omentum harbored lymph nodes in nine ( 18 % ) patients . The omental lymph nodes contained metastases in one ( 2 % ) patient , still free of disease after 20 months . Omental tumor deposits were found in four ( 8 % ) patients ; one died peritoneal carcinomatosa after 4 , 4 , and 8 months . Patients with omental tumor deposits had a significantly reduced 1-year disease-free survival compared to patients without tumor deposits ( 0 vs. 58.7 % , p = 0.003 ) . No predictive factors for omental tumor involvement could be identified . Conclusion Omental lymph node metastases or tumor deposits are present in 10 % of Western European patients undergoing gastrectomy for gastric cancer . Omentectomy has a prognostic and oncologic value in the curative treatment of patients with gastric cancer . As no predictive factors for omental tumor involvement could be identified , omentectomy should be the st and ard in gastrectomy for gastric cancer patients",
"PURPOSE The safety and efficacy of radical laparoscopic distal gastrectomy ( LG ) with D2 lymphadenectomy for the treatment of advanced gastric cancer ( AGC ) remain controversial . We conducted a r and omized controlled trial to compare laparoscopic and conventional open distal gastrectomy with D2 lymph node dissections for AGC . PATIENTS AND METHODS Between September 2012 and December 2014 , 1,056 patients with clinical stage T2 - 4aN0 - 3M0 gastric cancer were eligible for inclusion . They were r and omly assigned to either the LG with D2 lymphadenectomy group ( n = 528 ) or the open gastrectomy ( OG ) with D2 lymphadenectomy group ( n = 528 ) . Fifteen experienced surgeons from 14 institutions in China participated in the study . The morbidity and mortality within 30 days after surgery between the LG ( n = 519 ) and the OG ( n = 520 ) groups were compared on the basis of the modified intention-to-treat principle . Postoperative complications were stratified according to the Clavien-Dindo classification . RESULTS The compliance rates of D2 lymphadenectomy were similar between the LG and OG groups ( 99.4 % v 99.6 % ; P = .845 ) . The postoperative morbidity was 15.2 % in the LG group and 12.9 % in OG group with no significant difference ( difference , 2.3 % ; 95 % CI , -1.9 to 6.6 ; P = .285 ) . The mortality rate was 0.4 % for the LG group and zero for the OG group ( difference , 0.4 % ; 95 % CI , -0.4 to 1.4 ; P = .249 ) . The distribution of severity was similar between the two groups ( P = .314 ) . CONCLUSION Experienced surgeons can safely perform LG with D2 lymphadenectomy for AGC",
"PURPOSE Previous studies have demonstrated a beneficial effect of intraperitoneally applied mitomycin bound to activated carbon particles ( M-CH ) in preventing intraabdominal recurrence following curative surgery for gastric cancer . The Austrian Working Group for Stomach Cancer , a subgroup of the Austrian Working Group for Surgical Oncology , initiated a multicentric phase III trial to evaluate the safety and efficacy of this treatment regimen . PATIENTS AND METHODS A total of 91 patients with a radically resected gastric cancer infiltrating the serosal surface were r and omly assigned to receive either 50 mg mitomycin bound to a solution of 375 mg carbo adsorbens intraperitoneally before closure of the abdominal wound ( n = 46 ) or served as a surgical control group ( n = 45 ) . Postoperative complications and recurrence-free and overall survival were evaluated to analyze the risks and benefits of this treatment . RESULTS After a median observation period of 597 days ( range , 72 to 1,096 ) , a significantly higher postoperative complication rate was observed in the M-CH group ( 35 % ) compared with the control group ( 16 % ) ( P mortality rate was also significantly elevated in the M-CH group ( 11 % v 2 % in the control group ) . Since analysis of overall and recurrence-free survival failed to show any beneficial effect of M-CH therapy , the protocol committee decided to stop further recruitment of patients onto this study . CONCLUSION Adjuvant intraperitoneal therapy of gastric cancer by mitomycin bound to activated carbon particles is associated with an increased rate of postoperative complications . However , no benefit for prognosis following radical resection of locally advanced tumors was observed in this multicenter phase III trial",
"BACKGROUND Historical data and recent studies show that st and ardised extended ( D2 ) lymphadenectomy leads to better results than st and ardised limited ( D1 ) lymphadenectomy . Based on these findings , the Dutch D1D2 trial , a nationwide prospect ively r and omised clinical trial , was undertaken to compare D2 with D1 lymphadenectomy in patients with resectable primary adenocarcinoma of the stomach . The aim of the study was to assess the effect of D2 compared with D1 surgery on disease recurrence and survival in patients treated with curative intent . METHODS Between August , 1989 , and July , 1993 , patients were entered and r and omised at 80 participating hospitals by means of a telephone call to the central data centre of the trial . The sequence of r and omisation was in blocks of six with stratification for the participating centre . Eligibility criteria were a histologically proven adenocarcinoma of the stomach without evidence of distance metastasis , age younger than 85 years , and adequate physical condition for D1 or D2 lymphadenectomy . Patients were excluded if they had previous or coexisting cancer or had undergone gastrectomy for benign tumours . Strict quality control measures for pathological assessment were implemented and monitored . Analyses were by intention to treat . This study is registered with the NCI trial register , as DUT-KWF-CKVO-8905 , EU-90003 . FINDINGS A total of 1078 patients were entered in the study , of whom 996 were eligible . 711 patients underwent the r and omly assigned treatment with curative intent ( 380 in the D1 group and 331 in the D2 group ) and 285 had palliative treatment . Data were collected prospect ively and all patients were followed up for a median time of 15.2 years ( range 6.9 - 17.9 years ) . Analyses were done for the 711 patients treated with curative intent and were according to the allocated treatment group . Of the 711 patients , 174 ( 25 % ) were alive , all but one without recurrence . Overall 15-year survival was 21 % ( 82 patients ) for the D1 group and 29 % ( 92 patients ) for the D2 group ( p=0.34 ) . Gastric-cancer-related death rate was significantly higher in the D1 group ( 48 % , 182 patients ) compared with the D2 group ( 37 % , 123 patients ) , whereas death due to other diseases was similar in both groups . Local recurrence was 22 % ( 82 patients ) in the D1 group versus 12 % ( 40 patients ) in D2 , and regional recurrence was 19 % ( 73 patients ) in D1 versus 13 % ( 43 patients ) in D2 . Patients who had the D2 procedure had a significantly higher operative mortality rate than those who had D1 ( n=32 [ 10 % ] vs n=15 [ 4 % ] ; 95 % CI for the difference 2 - 9 ; p=0.004 ) , higher complication rate ( n=142 [ 43 % ] vs n=94 [ 25 % ] ; 11 - 25 ; p higher reoperation rate ( n=59 [ 18 % ] vs n=30 [ 8 % ] ; 5 - 15 ; p=0.00016 ) . INTERPRETATION After a median follow-up of 15 years , D2 lymphadenectomy is associated with lower locoregional recurrence and gastric-cancer-related death rates than D1 surgery . The D2 procedure was also associated with significantly higher postoperative mortality , morbidity , and reoperation rates . Because a safer , spleen-preserving D2 resection technique is currently available in high-volume centres , D2 lymphadenectomy is the recommended surgical approach for patients with resectable ( curable ) gastric cancer . FUNDING Dutch Health Insurance Funds Council and The Netherl and s Cancer Foundation",
"BACKGROUND Classic surgical treatment of upper third gastric carcinoma is based on an extended total gastrectomy , including splenectomy . The purpose of this study was to perform a prospect i ve r and omized clinical trial comparing the early and late results of total gastrectomy ( TG ) versus total gastrectomy plus splenectomy ( TGS ) . METHODS One hundred eighty-seven patients with gastric carcinoma were included . In all patients a D2 total gastrectomy was performed . During surgery they were r and omized to 1 of 2 operative options . They were monitored to their death or to 5 years later if they were alive . RESULTS Operative mortality was similar after both operations ( 3 % after TG and 4 % after TGS ) . Septic complications after surgery were higher after TGS compared with TG ( P Five-year survival rates were not statistically different between groups or in subset analysis according to stage of disease . CONCLUSIONS On the basis of the results of the present prospect i ve r and omized trial , splenectomy is not necessary in early stages of disease . A low operative mortality rate ( less than 3 % ) must be achieved to obtain good long-term results",
"BACKGROUND / AIMS Although the most frequent cause of death after curative resection of advanced gastric cancer is peritoneal recurrence , there was no effective therapy for the prevention of peritoneal recurrence . This r and omized trial sought to determine whether intraoperative chemohyperthermic peritoneal perfusion could eliminate microscopic residual disease and thereby improve survival of patients with advanced gastric cancer . METHODOLOGY One-hundred and thirty-nine patients with T2 - 4 gastric cancer underwent curative gastrectomy with extended lymphadenectomy . These patients were r and omly allocated into the following three groups . Patients in the CHPP group received surgery + chemohyperthermic peritoneal perfusion , and those in the CNPP group underwent surgery + chemonormothermic peritoneal perfusion . The third group was surgery alone group . In the CHPP and CNPP groups , peritoneal cavity was perfused with 6 - 8 liters of heated saline at , respectively , 42 - 43 degrees C and 37 degrees C with 30 mg of mitomycin C and 300 mg of cisplatin by a extracorporeal circulation machine . RESULTS Major operative complication occurred in 19 % ( 9/48 ) , 14 % ( 6/44 ) and 19 % ( 9/47 ) of the CHPP , CNPP and surgery alone group , respectively . Complication which uniquely developed after chemohyperthermic peritoneal perfusion was bowel perforation . Mortality rates of each group were 4 % ( 2/48 ) , 0 % ( 0/44 ) and 4 % ( 2/47 ) in the CHPP , CNPP and surgery alone group , respectively . Overall 5-year survival rates of CHPP , CNPP and surgery alone groups were 61 % , 43 % and 42 % , respectively . In a subset analysis , patients with gastric cancer having serosal invasion or lymph node metastasis have shown a statistically significant improvement in survival when treated with chemohyperthermic peritoneal perfusion . However , chemonormothermic peritoneal perfusion had no survival benefit . By analyzing with Cox proportional hazard model , chemohyperthermic peritoneal perfusion emerged as an independent prognostic factor for good survival . Surgery alone had three-fold higher risk of death than chemohyperthermic peritoneal perfusion . CONCLUSIONS Chemohyperthermic peritoneal perfusion had an efficiency for the prophylaxis of recurrence after curative resection of advanced gastric cancer , and is indicated for patients with tumor infiltrating beyond serosal layer and node positive tumor",
"BACKGROUND AND OBJECTIVES The role of radiation therapy in resectable gastric cancer is question able . To study the value of concentrated preoperative radiotherapy , a r and omized clinical trial had been carried out . METHODS From 1974 to 1978 , 152 patients were r and omized and underwent exploratory laparotomy ; in 50 patients curative surgery was not possible , while 102 patients satisfied protocol requirements and entered in the trial . Patients in the experimental group were treated with preoperative radiotherapy ( 20 Gy/5 days ) and subtotal or total gastrectomy . Patients in the control group underwent surgery alone . RESULTS Study showed acceptable tolerance of radiotherapy regime with no increase of postoperative mortality and morbidity . There was no significant difference in survival between the two treatment groups ( chi 2 = 0.349 , df = 1 , P = 0.555 ) . Subset analysis also failed to demonstrate significant survival advantages of the combined treatment ; however , some positive trends were seen in patients with locally advanced gastric cancer . CONCLUSIONS Concentrated preoperative radiotherapy in the dose of 20 Gy is safe and feasible , but seems to be insufficient to improve survival in gastric cancer patients . However , the results are promising in selected subgroups of patients , which encourages future trials with adjuvant radiation therapy ",
"PURPOSE The long-term survival probability of patients who undergo surgery for stage 3 and 4 gastric cancer is poor , predominantly due to metastatic spread of the tumor . Depending on the type of tumor histology , the pathway of metastases is mainly peritoneal or hepatic dissemination . Interruption of this mechanism may be possible by intraperitoneal chemotherapy ( IPT ) . PATIENTS AND METHODS In a prospect i ve r and omized trial of 67 patients undergoing surgery for stage 3 and 4 gastric cancer , 33 patients underwent adjuvant postoperative IPT with cisplatin , while 34 control subjects remained untreated . RESULTS Patients in the treatment group received a median of four IPT perfusions . Apart from frequent nausea , no adverse reactions or complications were noted . The median disease-free survival duration s were 12.7 months and 9.7 months in treated patients and controls , respectively ( P = .8 ) . After a median follow-up duration of 72 months , 54 patients ( 80 % ) had died of primary disease or related complications . The median survival duration for IPT patients was 17.3 months as compared with 16.0 months for controls ( P = .6 ) . Autopsies were performed on 12 ( 18 % ) of 54 patients who died , and showed tumor spread to the peritoneal cavity and /or to the liver , irrespective of the application of IPT . CONCLUSION IPT with cisplatin monotherapy does not improve survival probability after surgery for stage 3 and 4 gastric cancer . The reasons for ineffectiveness of IPT may be the choice of an unsuitable chemotherapeutic agent , an inefficient modus of application , or a lack of sufficient drug penetration into the serosa or peritoneal metastasis",
"The majority of advanced gastric carcinoma patients with serosal invasion die of peritoneal recurrence , even when a curative gastrectomy is performed , because peritoneal recurrence occurs due to intraperitoneal free tumor cells that detach from the serosal‐invaded focus . In an attempt to prevent peritoneal recurrence , intraperitoneal hyperthermic chemoperfusion ( IHCP ) treatment was combined with aggressive surgery",
"BACKGROUND Vascular endothelial growth factor ( VEGF ) and VEGF receptor-2 (VEGFR-2)-mediated signalling and angiogenesis can contribute to the pathogenesis and progression of gastric cancer . We aim ed to assess whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , prolonged survival in patients with advanced gastric cancer . METHODS We did an international , r and omised , double-blind , placebo-controlled , phase 3 trial between Oct 6 , 2009 , and Jan 26 , 2012 , at 119 centres in 29 countries in North America , Central and South America , Europe , Asia , Australia , and Africa . Patients aged 24 - 87 years with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression after first-line platinum-containing or fluoropyrimidine-containing chemotherapy were r and omly assigned ( 2:1 ) , via a central interactive voice-response system , to receive best supportive care plus either ramucirumab 8 mg/kg or placebo , intravenously once every 2 weeks . The study sponsor , participants , and investigators were masked to treatment assignment . The primary endpoint was overall survival . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00917384 . FINDINGS 355 patients were assigned to receive ramucirumab ( n=238 ) or placebo ( n=117 ) . Median overall survival was 5·2 months ( IQR 2·3 - 9·9 ) in patients in the ramucirumab group and 3·8 months ( 1·7 - 7·1 ) in those in the placebo group ( hazard ratio [ HR ] 0·776 , 95 % CI 0·603 - 0·998 ; p=0·047 ) . The survival benefit with ramucirumab remained unchanged after multivariable adjustment for other prognostic factors ( multivariable HR 0·774 , 0·605 - 0·991 ; p=0·042 ) . Rates of hypertension were higher in the ramucirumab group than in the placebo group ( 38 [ 16 % ] vs nine [ 8 % ] ) , whereas rates of other adverse events were mostly similar between groups ( 223 [ 94 % ] vs 101 [ 88 % ] ) . Five ( 2 % ) deaths in the ramucirumab group and two ( 2 % ) in the placebo group were considered to be related to study drug . INTERPRETATION Ramucirumab is the first biological treatment given as a single drug that has survival benefits in patients with advanced gastric or gastro-oesophageal junction adenocarcinoma progressing after first-line chemotherapy . Our findings vali date VEGFR-2 signalling as an important therapeutic target in advanced gastric cancer . FUNDING ImClone Systems",
"BACKGROUND Patients with advanced gastric or gastro-oesophageal junction cancer refractory to , or intolerant of , two or more previous regimens of chemotherapy have a poor prognosis , and current guidelines do not recommend any specific treatments for these patients . We assessed the efficacy and safety of nivolumab , a fully human IgG4 monoclonal antibody inhibitor of programmed death-1 ( PD-1 ) , in patients with advanced gastric or gastro-oesophageal junction cancer who had been previously been treated with two or more chemotherapy regimens . METHODS In this r and omised , double-blind , placebo-controlled , phase 3 trial done at 49 clinical sites in Japan , South Korea , and Taiwan , eligible patients ( aged ≥20 years with unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer refractory to , or intolerant of , st and ard therapy [ including two or more previous chemotherapy regimens ] , with an Eastern Cooperative Oncology Group [ ECOG ] performance status of 0 - 1 , and naive to anti-PD-1 therapy or other therapeutic antibodies and pharmacotherapies for the regulation of T cells ) were recruited . Patients were r and omly assigned ( 2:1 ) using an interactive web response system to receive 3 mg/kg nivolumab or placebo intravenously every 2 weeks , stratified by country , ECOG performance status , and number of organs with metastases . Study treatment was continued until progressive disease per investigator assessment or onset of toxicities requiring permanent discontinuation . Patients and investigators were masked to group assignment . The primary endpoint was overall survival in the intention-to-treat population . Safety was analysed in all patients who received at least one dose of study treatment . This study is ongoing but not recruiting new patients , and is registered with Clinical Trials.gov , number NCT02267343 . FINDINGS Between Nov 4 , 2014 , and Feb 26 , 2016 , we r and omly assigned 493 patients to receive nivolumab ( n=330 ) or placebo ( n=163 ) . At the data cutoff ( Aug 13 , 2016 ) , median follow-up in surviving patients was 8·87 months ( IQR 6·57 - 12·37 ) in the nivolumab group and 8·59 months ( 5·65 - 11·37 ) in the placebo group . Median overall survival was 5·26 months ( 95 % CI 4·60 - 6·37 ) in the nivolumab group and 4·14 months ( 3·42 - 4·86 ) in the placebo group ( hazard ratio 0·63 , 95 % CI 0·51 - 0·78 ; p rates were 26·2 % ( 95 % CI 20·7 - 32·0 ) with nivolumab and 10·9 % ( 6·2 - 17·0 ) with placebo . Grade 3 or 4 treatment-related adverse events occurred in 34 ( 10 % ) of 330 patients who received nivolumab and seven ( 4 % ) of 161 patients who received placebo ; treatment-related adverse events led to death in five ( 2 % ) of 330 patients in the nivolumab group and two ( 1 % ) of 161 patients in the placebo group . No new safety signals were observed . INTERPRETATION In this phase 3 study , the survival benefits indicate that nivolumab might be a new treatment option for heavily pretreated patients with advanced gastric or gastro-oesophageal junction cancer . Ongoing trials that include non-Asian patients are investigating nivolumab for advanced gastric or gastro-oesophageal junction cancer in various setting s and earlier treatment lines . FUNDING Ono Pharmaceutical and Bristol-Myers Squibb",
"BACKGROUND Patients with advanced gastric or gastro-oesophageal junction cancer that progresses on chemotherapy have poor outcomes . We compared pembrolizumab with paclitaxel in patients with advanced gastric or gastro-oesophageal junction cancer that progressed on first-line chemotherapy with a platinum and fluoropyrimidine . METHODS This r and omised , open-label , phase 3 study was done at 148 medical centres in 30 countries . Eligible patients were r and omised ( 1:1 ) in blocks of four per stratum with an interactive voice-response and integrated web-response system to receive either pembrolizumab 200 mg every 3 weeks for up to 2 years or st and ard-dose paclitaxel . Primary endpoints were overall survival and progression-free survival in patients with a programmed cell death lig and 1 ( PD-L1 ) combined positive score ( CPS ) of 1 or higher . Safety was assessed in all patients , irrespective of CPS . The significance threshold for overall survival was p=0·0135 ( one-sided ) . This trial is registered at Clinical Trials.gov , number NCT02370498 . FINDINGS Between June 4 , 2015 , and July 26 , 2016 , 592 patients were enrolled . Of the 395 patients who had a PD-L1 CPS of 1 or higher , 196 patients were assigned to receive pembrolizumab and 199 patients were assigned to receive paclitaxel . As of Oct 26 , 2017 , 326 patients in the population with CPS of 1 or higher had died ( 151 [ 77 % ] of 196 patients in the pembrolizumab group and 175 [ 88 % ] of 199 patients in the paclitaxel group ) . Median overall survival was 9·1 months ( 95 % CI 6·2 - 10·7 ) with pembrolizumab and 8·3 months ( 7·6 - 9·0 ) with paclitaxel ( hazard ratio [ HR ] 0·82 , 95 % CI 0·66 - 1·03 ; one-sided p=0·0421 ) . Median progression-free survival was 1·5 months ( 95 % CI 1·4 - 2·0 ) with pembrolizumab and 4·1 months ( 3·1 - 4·2 ) with paclitaxel ( HR 1·27 , 95 % CI 1·03 - 1·57 ) . In the total population , grade 3 - 5 treatment-related adverse events occurred in 42 ( 14 % ) of the 294 patients treated with pembrolizumab and 96 ( 35 % ) of the 276 patients treated with paclitaxel . INTERPRETATION Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher . Pembrolizumab had a better safety profile than paclitaxel . Additional trials of pembrolizumab in gastric and gastro-oesophageal cancer are ongoing . FUNDING Merck Sharp & Dohme , a subsidiary of Merck &",
"Background Laparoscopic gastrectomy ( LG ) has several benefits as a treatment of gastric cancer ( GC ) , including reduced pain , early recovery of intestinal function , and shorter hospital stay . LG still has several drawbacks , however , including limited range of movement , amplification of h and tremors , and inconvenient surgical positioning . Around the peripancreatic area , laparoscopic lymph node dissection , therefore , remains challenging ; postoperative pancreatic fistula occurs in around 4–7 % of patients undergoing LG . Robotic surgery , on the other h and , plays a role in ergonomics and offers several advantages , including 7 ° of wrist-like motion , less fatigue , tremor filtering , motion scaling , and three-dimensional vision . In our previous retrospective study , we compared the safety and feasibility of surgical outcomes of LG and robotic gastrectomy ( RG ) for patients with GC . In our previous results , in the LG group , intra-abdominal infectious complications were found in 11 % . In the RG group , however , none were found . Our RG procedure may be associated with decreased incidence of intra-abdominal infectious complications . Prospect i ve r and omized controlled trials ( RCTs ) comparing LG and RG are required , however . We begin an RCT to compare short-term surgical and long-term oncological outcomes of LG and RG for GC patients . Methods This is a r and omized , single-center clinical trial . All included patients are adults with primary carcinoma of the stomach , in whom the tumor is considered surgically resectable ( stages I – III ) . Included in this trial are 240 patients with GC . The primary endpoint is to assess the incidence of postoperative intra-abdominal infectious complications including pancreatic fistula , intra-abdominal abscess , and anastomotic leakage . Secondary endpoints include the incidence of any complications ( both related and unrelated to surgery ) , surgical results , postoperative course , and oncological outcomes . Discussion Although its short-term outcomes have been proven comparable to LG in comparative studies , use of RG remains restricted , partly due to the lack of informative RCTs pertaining to it . To evaluate the surgical and oncological outcomes of RG , we therefore undertake a prospect i ve RCT . The obtained results will be useful for reducing the restrictions and for adaptive expansion of RG for patients with GC.Trial registration University Hospital Medical Information Network Clinical Trials Registry , ID : UMIN000031536 . Registered on 1 March 2017",
"Background Although radical gastrectomy with D2 lymph node dissection has become the st and ard surgical approach for locally advanced gastric cancer , patients still have a poor prognosis after operation . Previously , we proposed laparoscopic distal gastrectomy ( D2 lymphadenectomy plus complete mesogastrium excision [ D2 + CME ] ) as an optimized surgical procedure for locally advanced gastric cancer . By dissection along the boundary of the mesogastrium , D2 + CME resected proximal segments of the dorsal mesogastrium completely with less blood loss , and it improved the short-term surgical outcome . However , the oncologic therapeutic effect of D2 + CME has not yet been confirmed . Methods / design A single-center , prospect i ve , parallel-group , r and omized controlled trial of laparoscopic distal gastrectomy with D2 + CME versus conventional D2 was conducted for patients with locally advanced gastric cancer at Tongji Hospital , Wuhan , China . In total , 336 patients who met the following eligibly criteria were included and were r and omized to receive either the D2 + CME or D2 procedure : ( 1 ) pathologically proven adenocarcinoma ; ( 2 ) 18 to 75 years old ; cT2–4 , N0–3 , M0 at preoperative evaluation ; ( 3 ) expected curative resection via laparoscopic distal gastrectomy ; ( 4 ) no history of other cancer , chemotherapy , or radiotherapy ; ( 5 ) no history of upper abdominal operation ; and ( 6 ) perioperative American Society of Anesthesiologists class I , II , or III . The primary endpoint is 3 years of disease-free survival . The secondary endpoints are overall survival , recurrence pattern , mortality , morbidity , postoperative recovery course , and other parameters . Discussion Previous studies have demonstrated the safety and feasibility of D2 + CME for locally advanced gastric cancer ; however , there is still a lack of evidence to support its therapeutic effect . Thus , we performed this r and omized trial to investigate whether D2 + CME can improve oncologic outcomes of patients with locally advanced gastric cancer . The findings from this trial may potentially optimize the surgical procedure and may improve the prognosis of patients with locally advanced gastric cancer . Trial registration Clinical Trials.gov , NCT01978444 . Registered on October 31 , 2013",
"Background With improved short-term surgical outcomes , laparoscopic distal gastrectomy has rapidly gained popularity . However , the safety and feasibility of laparoscopic total gastrectomy ( LTG ) has not yet been proven due to the difficulty of the technique . This single-arm prospect i ve multi-center study was conducted to evaluate the use of LTG for clinical stage I gastric cancer . Methods Between October 2012 and January 2014 , 170 patients with pathologically proven , clinical stage I gastric adenocarcinoma located at the proximal stomach were enrolled . Twenty-two experienced surgeons from 19 institutions participated in this clinical trial . The primary end point was the incidence of postoperative morbidity and mortality at postoperative 30 days . The severity of postoperative complications was categorized according to Clavien – Dindo classification , and the incidence of postoperative morbidity and mortality was compared with that in a historical control . Results Of the enrolled patients , 160 met criteria for inclusion in the full analysis set . Postoperative morbidity and mortality rates reached 20.6 % ( 33/160 ) and 0.6 % ( 1/160 ) , respectively . Fifteen patients ( 9.4 % ) had grade III or higher complications , and three reoperations ( 1.9 % ) were performed . The incidence of morbidity after LTG in this trial did not significantly differ from that reported in a previous study for open total gastrectomy ( 18 % ) . Conclusions LTG performed by experienced surgeons showed acceptable postoperative morbidity and mortality for patients with clinical stage I gastric cancer",
"Background The safety of laparoscopic total gastrectomy ( LTG ) for the treatment of gastric cancer remains lack of clinical evidence . The Chinese Laparoscopic Gastrointestinal Surgery Study ( CLASS ) Group recently launched a multicenter r and omized clinical trial ( CLASS02–01 ) to compare the safety of LTG for clinical stage I gastric cancer with the conventional open total gastrectomy ( OTG ) . Methods This CLASS02–01 trial is a prospect i ve , multicenter , r and omized , controlled , open , and non-inferiority trial . Two hundred patients who met the inclusion criteria and did not accord with the exclusion criteria will be r and omly divided into LTG group ( n = 100 ) and OTG group ( n = 100 ) . The primary purpose of this study is to evaluate the early operative morbidity and mortality of LTG compared with OTG for clinical stage I gastric adenocarcinoma . The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study . Discussion This CLASS02–01 trial is the first prospect i ve r and omized two-arm controlled study to determine the safety of LTG compared with OTG . Through this trial , we hope to show that experienced surgeons can safely perform LTG with lymphadenectomy for gastric cancer . Trial registration Clinical Trials.gov ID : NCT03007550 . December 30 , 2016",
"Purpose Clinical implication s of single patient classifier ( SPC ) and microsatellite instability ( MSI ) in stage II/III gastric cancer have been reported . We investigated SPC and the status of MSI and Epstein-Barr virus ( EBV ) as combinatory biomarkers to predict the prognosis and responsiveness of adjuvant chemotherapy for stage II/III gastric cancer . Material s and Methods Tumor specimens and clinical information were collected from patients enrolled in CLASSIC trial , a r and omized controlled study of capecitabine plus oxaliplatin-based adjuvant chemotherapy . The results of nine-gene based SPC assay were classified as prognostication ( SPC-prognosis ) and prediction of chemotherapy benefit ( SPC-prediction ) . Five quasimonomorphic mononucleotide markers were used to assess tumor MSI status . EBV-encoded small RNA in situ hybridization was performed to define EBV status . Results There were positive associations among SPC , MSI , and EBV statuses among 586 patients . In multivariate analysis of disease-free survival , SPC-prognosis [ hazard ratio ( HR ) : 1.879 ( 1.101–3.205 ) , 2.399 ( 1.415–4.067 ) , p=0.003 ] and MSI status ( HR : 0.363 , 95 % confidence interval : 0.161–0.820 , p=0.015 ) were independent prognostic factors along with age , Lauren classification , TNM stage , and chemotherapy . Patient survival of SPC-prognosis was well stratified regardless of EBV status and in microsatellite stable ( MSS ) group , but not in MSI-high group . Significant survival benefit from adjuvant chemotherapy was observed by SPC-Prediction in MSS and EBV-negative gastric cancer . Conclusion SPC , MSI , and EBV statuses could be used in combination to predict the prognosis and responsiveness of adjuvant chemotherapy for stage II/III gastric cancer",
"ABSTRACT Background : Traditionally , total omentectomy is performed along with gastric resection and extended lymphadenectomy in gastric cancer ( GC ) surgery . However , solid evidence s regarding its oncologic benefit is still scarce . Aim : To evaluate the incidence of metastatic omental lymph nodes ( LN ) in patients undergoing curative gastrectomy for GC , as well as its risk factors and patients ’ outcomes . Methods : All consecutive patients su bmi tted to D2/modified D2 gastrectomy due to gastric adenocarcinoma from March 2009 to April 2016 were retrospectively review ed from a prospect i ve collected data base . Results : Of 284 patients included , five ( 1.8 % ) patients had metastatic omental LN ( one : pT3N3bM0 ; two : pT4aN3bM0 ; one : pT4aN2M0 and one pT4bN3bM0 ) . Four of them deceased and one was under palliative chemotherapy due relapse . LN metastases in the greater omentum significantly correlated with tumor ’s size ( p=0.018 ) , N stage ( p clinical stage ( p=0.022 ) , venous invasion growth ( p=0.003 ) , recurrence ( p=0.006 ) , site of recurrence ( peritoneum : p=0.008 ; liver : p=0.023 ; ovary : p=0.035 ) and death ( p=0.008 ) . Conclusion : The incidence of metastatic omental LN of patients undergoing radical gastrectomy due to GC is extremely low . Total omentectomy may be avoided in tumors smaller than 5.25 cm and T1/T2 tumors . However , the presence of lymph node metastases in the greater omentum is associated with recurrence in the peritoneum , liver , ovary and death",
"Background sLaparoscopy-assisted distal gastrectomy ( LADG ) for gastric cancer is safe and feasible . In contrast , no prospect i ve study evaluating the safety and efficacy of laparoscopy-assisted total gastrectomy ( LATG ) or laparoscopy-assisted proximal gastrectomy ( LAPG ) has been completed . We conducted a single-arm confirmatory trial to evaluate the safety of LATG/LAPG for clinical stage I ( T1N0/T1N1/T2N0 ) proximal gastric cancer . Methods The extent of lymphadenectomy was selected based on the Japanese Gastric Cancer Treatment Guidelines . The mini-laparotomy incision was required to be ≤ 6 cm . The primary endpoint was the proportion of grade 2–4 ( CTCAE ver . 4.0 ) esophagojejunal anastomotic leakage . The planned sample size was 245 considering a threshold of 8 % and one-sided alpha of 2.5 % . Results Between April 2015 and February 2017 , 244 eligible patients were enrolled . LATG/LAPG was performed in 195/49 . The proportion of conversions was 1.7 % . Clinical T1N0/T1N1/T2N0 was 212/9/23 . The extents of lymphadenectomy were as follows : D1 + : 229 ; D2 : 15 . The median operation time was 309 min ( IQR 265–353 ) . The median blood loss was 30 ml ( IQR 10–86 ) . Grade 2–4 esophagojejunal anastomotic leakage was 2.5 % ( 6/244 ; 95 % CI 0.9–5.3 ) . The overall proportion of in-hospital grade 3–4 adverse events was 29 % ( 71/244 ) . The proportions of intraabdominal abscess and pancreatic fistula were 3.7 % and 2.0 % , respectively . There were no treatment-related deaths . Conclusions This trial confirmed the safety of LATG/LAPG . After the non-inferiority of LADG is confirmed in our phase III trial ( JCOG0912 ) , LATG/LAPG is expected to be established as one of the st and ard treatments for clinical stage I gastric cancer",
"Importance Laparoscopic distal gastrectomy is gaining popularity over open distal gastrectomy for gastric cancer because of better early postoperative outcomes . However , to our knowledge , no studies have proved whether laparoscopic distal gastrectomy is oncologically equivalent to open distal gastrectomy . Objective To examine whether the long-term survival among patients with stage I gastric cancer undergoing laparoscopic distal gastrectomy is noninferior to that among patients undergoing open distal gastrectomy . Design The Korean Laparoendoscopic Gastrointestinal Surgery Study ( KLASS ) group , which includes 15 surgeons from 13 institutes , conducted a phase 3 , multicenter , open-label , noninferiority , prospect i ve r and omized clinical trial ( KLASS-01 ) of patients with histologically proven , preoperative clinical stage I gastric adenocarcinoma from January 5 , 2006 , to August 23 , 2010 . Survival and recurrence status of the patients was determined in December 2016 . Interventions Patients were r and omly assigned ( 1:1 ) to laparoscopic distal gastrectomy ( n = 705 ) or open distal gastrectomy ( n = 711 ) . Of these patients , 85 received a surgical approach opposite the one to which they were r and omized ( 63 r and omized to the open surgery group and 22 to the laparoscopic group ) . Main Outcomes and Measures Difference in 5-year overall survival between the laparoscopic and open distal gastrectomy groups . The noninferiority margin was prespecified as −5 % ( corresponding hazard ratio of 1.54 ) , with an assumed survival of 90 % after 5 years in the open surgery group . Results Among the 1416 patients ( mean [ SD ] age , 57.3 [ 11.1 ] years ; 940 [ 66.4 % ] male ) included in the study , the 5-year overall survival rates were 94.2 % in the laparoscopic group and 93.3 % in the open surgery group ( log-rank P = .64 ) . Intention-to-treat analysis confirmed the noninferiority of the laparoscopic approach compared with the open approach ( difference , 0.9 percentage points ; 1-sided 97.5 % CI , −1.6 to infinity ) . The 5-year cancer-specific survival rates were similar between the 2 groups ( 97.1 % in the laparoscopic group and 97.2 % in the open surgery group , log-rank P = .91 ; difference , −0.03 percentage points ; 1-sided 97.5 % CI , −1.8 to infinity ) . Per- protocol analysis results were consistent with the intention-to-treat results for overall and cancer-specific survival rates . Conclusions and Relevance The KLASS-01 trial revealed similar overall and cancer-specific survival rates between patients receiving laparoscopic and open distal gastrectomy . Laparoscopic distal gastrectomy is an oncologically safe alternative to open surgery for stage I gastric cancer . Trial Registration Clinical Trials.gov identifier :",
"BACKGROUND Surgical resection is the only curative treatment option for gastric cancer . Despite widespread adoption of multimodality perioperative treatment strategies , 5-year overall survival rates remain low . In patients with advanced gastric or gastroesophageal junction adenocarcinoma , pembrolizumab has demonstrated promising efficacy and manageable safety as monotherapy in previously treated patients and as first-line therapy in combination with cisplatin and 5-fluorouracil . Combining chemotherapy with pembrolizumab in the neoadjuvant/adjuvant setting may benefit patients with locally advanced , resectable disease . AIM To describe the design and rationale for the global , multicenter , r and omized , double-blind , Phase III KEYNOTE-585 study to evaluate the efficacy and safety of pembrolizumab plus chemotherapy compared with placebo plus chemotherapy as neoadjuvant/adjuvant treatment for localized gastric or gastroesophageal junction adenocarcinoma . Clinical Trials.gov : NCT03221426",
"OBJECTIVE The aim of the study was to evaluate the short-term outcomes of KLASS-02- RCT , a multicenter r and omized controlled trial comparing laparoscopic distal gastrectomy ( LDG ) with D2 lymphadenectomy with open distal gastrectomy ( ODG ) . SUMMARY BACKGROUND DATA Although several benefits of laparoscopic gastric cancer surgery have been reported , strong evidence is still limited , especially in locally advanced gastric cancer which requires extensive lymph node dissection . METHODS Enrollment criteria included histologically confirmed cT2 - 4a and N0 - 1 gastric adenocarcinoma . Thirty-day morbidity , 90-day mortality , postoperative pain , and recovery were compared between LDG and ODG groups . RESULTS A total of 1050 patients were r and omly assigned to LDG ( n = 526 ) or ODG group ( n = 524 ) between November 2011 and April 2015 . After excluding patients who received bypass or no surgery , 1011 patients were analyzed as actual treatment group . Mean number of totally retrieved lymph nodes was similar in both groups ( LDG = 46.6 vs ODG = 47.4 , P = 0.451 ) . Early morbidity rate was significantly lower after LDG ( 16.6 % ) than after ODG ( 24.1 % ; P = 0.003 ) . Postoperative analgesics use and patients ' reported pain score were significantly lower after LDG . First day of flatus was earlier after LDG ( 3.5 vs 3.7 d , P = 0.025 ) and postoperative hospital stay was shorter in LDG group ( 8.1 vs 9.3 d , P = 0.005 ) . Ninety days ' mortality rate was similar in both groups ( LDG = 0.4 % vs ODG = 0.6 % , P = 0.682 ) . CONCLUSIONS Laparoscopic distal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer shows benefits in terms of lower complication rate , faster recovery , and less pain compared with open surgery",
"Importance Laparoscopic distal gastrectomy is accepted as a more effective approach to conventional open distal gastrectomy for early-stage gastric cancer . However , efficacy for locally advanced gastric cancer remains uncertain . Objective To compare 3-year disease-free survival for patients with locally advanced gastric cancer after laparoscopic distal gastrectomy or open distal gastrectomy . Design , Setting , and Patients The study was a noninferiority , open-label , r and omized clinical trial at 14 centers in China . A total of 1056 eligible patients with clinical stage T2 , T3 , or T4a gastric cancer without bulky nodes or distant metastases were enrolled from September 2012 to December 2014 . Final follow-up was on December 31 , 2017 . Interventions Participants were r and omized in a 1:1 ratio after stratification by site , age , cancer stage , and histology to undergo either laparoscopic distal gastrectomy ( n = 528 ) or open distal gastrectomy ( n = 528 ) with D2 lymphadenectomy . Main Outcomes and Measures The primary end point was 3-year disease-free survival with a noninferiority margin of -10 % to compare laparoscopic distal gastrectomy with open distal gastrectomy . Secondary end points of 3-year overall survival and recurrence patterns were tested for superiority . Results Among 1056 patients , 1039 ( 98.4 % ; mean age , 56.2 years ; 313 [ 30.1 % ] women ) had surgery ( laparoscopic distal gastrectomy [ n=519 ] vs open distal gastrectomy [ n=520 ] ) , and 999 ( 94.6 % ) completed the study . Three-year disease-free survival rate was 76.5 % in the laparoscopic distal gastrectomy group and 77.8 % in the open distal gastrectomy group , absolute difference of -1.3 % and a 1-sided 97.5 % CI of -6.5 % to ∞ , not crossing the prespecified noninferiority margin . Three-year overall survival rate ( laparoscopic distal gastrectomy vs open distal gastrectomy : 83.1 % vs 85.2 % ; adjusted hazard ratio , 1.19 ; 95 % CI , 0.87 to 1.64 ; P = .28 ) and cumulative incidence of recurrence over the 3-year period ( laparoscopic distal gastrectomy vs open distal gastrectomy : 18.8 % vs 16.5 % ; subhazard ratio , 1.15 ; 95 % CI , 0.86 to 1.54 ; P = .35 ) did not significantly differ between laparoscopic distal gastrectomy and open distal gastrectomy groups . Conclusions and Relevance Among patients with a preoperative clinical stage indicating locally advanced gastric cancer , laparoscopic distal gastrectomy , compared with open distal gastrectomy , did not result in inferior disease-free survival at 3 years . Trial Registration Clinical Trials.gov Identifier : NCT01609309",
"A phase II trial was started in Japan to evaluate the safety of laparoscopy-assisted distal gastrectomy ( LADG ) for clinical stage I gastric cancer . A total of 170 patients will be enrolled in this study by expert surgeons for laparoscopy from 16 institutions over 1 year . The primary endpoint is incidence of anastomotic leak and pancreatic fistula . The secondary endpoints are overall survival , relapse-free survival , proportion of completion of LADG , proportion of conversion from LADG to open gastrectomy , surgical morbidity and short-term clinical outcomes",
"Summary Controversy still exists on the optimal surgical resection for potentially curable gastric cancer . Much better long-term survival has been reported in retrospective/non-r and omized studies with D2 resections that involve a radical extended regional lymphadenectomy than with the st and ard D1 resections . In this paper we report the long-term survival of patients entered into a r and omized study , with follow-up to death or 3 years in 96 % of patients and a median follow-up of 6.5 years . In this prospect i ve trial D1 resection ( removal of regional perigastric nodes ) was compared with D2 resection ( extended lymphadenectomy to include level 1 and 2 regional nodes ) . Central r and omization followed a staging laparotomy . Out of 737 patients with histologically proven gastric adenocarcinoma registered , 337 patients were ineligible by staging laparotomy because of advanced disease and 400 were r and omized . The 5-year survival rates were 35 % for D1 resection and 33 % for D2 resection ( difference –2 % , 95 % CI = –12%–8 % ) . There was no difference in the overall 5-year survival between the two arms ( HR = 1.10 , 95 % CI 0.87–1.39 , where HR > 1 implies a survival benefit to D1 surgery ) . Survival based on death from gastric cancer as the event was similar in the D1 and D2 groups ( HR = 1.05 , 95 % CI 0.79–1.39 ) as was recurrence-free survival ( HR = 1.03 , 95 % CI 0.82–1.29 ) . In a multivariate analysis , clinical stages II and III , old age , male sex and removal of spleen and pancreas were independently associated with poor survival . These findings indicate that the classical Japanese D2 resection offers no survival advantage over D1 surgery . However , the possibility that D2 resection without pancreatico-splenectomy may be better than st and ard D1 resection can not be dismissed by the results of this trial"
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The presence of residues within the root canal after post-space preparation can influence the bond strength between resin cement and root dentin when using fiberglass posts ( FGPs ) . Currently , there is no consensus in the literature regarding what is the best solution for the removal of debris after post-space preparation . This systematic review involved " in vitro " studies to investigate if cleaning methods of the root canal after post-space preparation can increase the retention of FGPs evaluated by the push-out test . Search es were carried out in PubMed ( MEDLINE ) and Scopus data bases up to July2017 . English language studies published from 2007 to July 2017 were selected . 475 studies were found , and 9 were included in this review . Information from the 9 studies were collected regarding the number of sample s , storage method after extraction , root canal preparation , method of post-space preparation , endodontic sealer , resin cement , cleaning methods after post-space and presence of irrigant activation . Five studies presented the best results for the association of sodium hypochlorite ( NaOCl ) and ethylenediamine tetra-acetic acid ( EDTA ) , while in the other 4 studies , the solutions that showed improved retention of FGPs were photon-induced photoacoustic streaming ( PIPS ) , Qmix , Sikko and EDTA . The results showed heterogeneity in all comparisons due to a high variety of information about cleaning methods , different concentrations , application time , type of adhesive system and resin cements used . In conclusion , this review suggests that the use of NaOCl/EDTA results in the retention of FGPs and may thus be recommended as a post-space cleaning method influencing the luting procedure
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"OBJECTIVE The aim of this study was to evaluate the effect of five intracanal irrigants on bond strength of fiber posts cemented with newer self-adhesive resin cement . METHODS A total of 60 extracted , single-rooted human premolars , sectioned at 14 mm , were prepared with the ProTaper Universal system with a size F3 instrument and filled with an F3 master cone and AH Plus . The root canal filling was partially removed , leaving 4 mm of apical gutta-percha . Specimens were r and omly assigned to five groups ( n=12 ) , according to the solution used for dentin surface treatment before fiber post cementation , as follows : EDTA 17 % ( EDTA ) ; QMix ( QM ) ; SmearClear ( SC ) ; 2.5 % sodium hypochlorite ( NaOCl ) , and 0.9 % saline solution ( SS ) . Ultrasonic activation was performed ( three times , 20 seconds each ) , and root canals were dried with paper points . Fiber posts were cemented with RelyX U200 . In one specimen per group , rhodamine B dye was mixed with RelyX U200 to provide adequate fluorescence for confocal laser scanning microscopy ( CLSM ) assessment . Specimens were transversally sectioned and three slices were obtained , one for each root third . Next , a push-out test was performed . A stereomicroscope and CLSM were used to analyze the failure modes and to illustrate the pattern of infiltration of RelyX U200 into dentinal tubules , respectively . Bond strength means were calculated , and analysis of variance and Bonferroni tests were used for statistical analysis . RESULTS SS showed the highest mean bond strength values ( 11.5±5.3 ) , superior to QM ( 5.1±3.1 ) and SC ( 5.1±3.3 ) . NaOCl presented intermediary bond strength values ( 9.7±5.0 ) , similar to EDTA ( 7.7±2.9 ) and SS . QM and SC showed the lowest mean bond strength ( p were predominant ( 53.9 % ) . CONCLUSION SS and NaOCl associated with ultrasonic activation seem to be adequate solutions for root canal cleaning before fiber post cementation with self-adhesive resin cement , whereas chelating solutions , such as EDTA , QM , and SC , cause a decrease in bond strength ",
"AIM This study evaluated the effects of different root canal sealers on the bond strength of a fibreglass post cemented with self-adhesive resin cements . METHODOLOGY The root canals of 50 extracted maxillary single-rooted canine teeth were prepared with the crown-down technique and r and omly divided into five groups according to the sealer used : group 1 : control group , gutta-percha points only ( no sealer ) ; group 2 : AH Plus ( resin-based sealer ) ; group 3 : self-etch Epiphany ( resin-based sealer ) ; group 4 : Sealer 26 ( calcium hydroxide-based sealer ) ; and group 5 : Endomethasone ( zinc oxide eugenol-based sealer ) . The root canals were filled with gutta-percha , the cold lateral compaction technique , except for group 3 where Resilon was used . Post spaces were prepared , and fibreglass posts were cemented with the self-adhesive cement RelyX Unicem . Bonded specimens were sectioned into 1-mm-thick slabs , and a push-out test was performed in a universal machine . Failure modes were observed and classified into five types : ( i ) adhesive between the post and resin cement ; ( ii ) mixed , with resin cement covering 0 - 50 % of the post diameter ; ( iii ) mixed , with resin cement covering 50 - 100 % of the post surface ; ( iv ) adhesive between resin cement and root canal ; and ( v ) cohesive in dentine . Data of bond strength were su bmi tted to anova and Tukey test ( α = 0.05 ) . RESULTS No significant difference was detected between control group , AH Plus , Epiphany and Sealer 26 ( P > 0.05 ) . The Endomethasone group had significantly lower bond strength values than the other sealers ( P of mixed fractures and adhesive cement-dentine failure was verified in the eugenol-containing sealer group ; in the control group , the resin-based and calcium hydroxide-based sealer groups , the predominant mode of failure was the mixed type . CONCLUSION Endomethasone interfered negatively with the bond to root dentine ; however , AH Plus , Epiphany and Sealer 26 did not interfere in the bond strength of a fibreglass post cemented with self-adhesive resin cements",
"INTRODUCTION This study compared the influence of different irrigants with and without ultrasound or laser irradiation on the bond strength of glass fiber posts using a self-etching adhesive in a supplementary dentin pretreatment . METHODS Ninety bovine incisor roots were divided into 3 groups according to the irrigant tested : 2 % chlorhexidine ( CHX ) ( n = 30 ) ; 2.5 % sodium hypochlorite ( NaOCl ) ( n = 30 ) , and saline solution ( control ) ( n = 30 ) . Each group was r and omly divided into 3 subgroups according to the supplementary dentin pretreatment : ultrasound , Nd : YAG laser , and nonsupplemented ( control ) . A self-etching adhesive system ( Futurabond DC ; VOCO GmbH , Cuxhaven , Germany ) was used , and the glass fiber posts were cemented with dual-cure epoxy-based luting agent ( Bifix QM , VOCO GmbH ) . All roots were sectioned transversely , and the push-out test was performed . Failure mode analysis was also evaluated . RESULTS Bond strength decreased significantly after the use of 2.5 % NaOCl in all root thirds ( P CHX showed no difference in the mean bond strength value compared with saline solution ( P > .05 ) . The supplementary dentin pretreatment using the Nd : YAG laser or ultrasound did not improve the bond strength values for both NaOCl and CHX ( P > .05 ) . Moreover , the apical third exhibited the lowest mean bond strength values ( P failure mode was the mixed type . CONCLUSIONS Regardless of the irrigant used , the supplementary dentin pretreatment with ultrasound or laser irradiation showed no improvement in bond strength . Also , the use of NaOCl decreased the bond strength of glass fiber posts using a self-etching adhesive system , whereas CHX preserved it",
"AIM To assess ex vivo , the antibacterial effectiveness of photon-initiated photoacoustic streaming ( PIPS ) of irrigants using an Er : YAG laser equipped with a newly design ed , stripped and tapered tip in extracted teeth with infected root canals . METHODOLOGY One hundred and forty-eight single-rooted extracted teeth were prepared to a size 25 , 0.06 taper . The specimens were sterilized , and all teeth except ten ( negative control group ) were inoculated with Enterococcus faecalis and incubated in a CO(2 ) chamber at 37 ° C for 15 days in Eppendorf tubes filled with trypticase soy broth medium changed every 2 days . Infected teeth were then r and omly divided into four test groups ( n = 32 for each ) : pulsed erbium/YAG laser at nonablative setting s for 30 s with sterile bi-distilled water ( Group A ) or 5 % sodium hypochlorite ( NaOCl ) ( Group B ) ; without laser-activated sterile bi-distilled water irrigation for 30 s ( Group C ) or 5 % NaOCl irrigation for 30 s ( Group D ) ; the positive control group received no treatment in infected teeth ( n = 10 ) . Colony-forming units ( CFUs ) were counted from bacteriologic sample s taken before ( S1 ) and after treatment ( S2 ) . Data were analysed by Kruskal-Wallis and post hoc Dunn 's multiple comparison tests . RESULTS CFU counts were significantly lower in 5 % NaOCl groups with or without laser activation than in sterile bi-distilled water without laser activation group ( P greatest CFU reduction , which was significantly greater than that evident in bi-distilled water groups with or without laser activation ( P 5 % NaOCl groups with or without laser activation ( P > 0.05 ) . None of the four groups generated negative sample s predictably . CONCLUSIONS Under the conditions of this ex vivo study , there were no significant differences in bacterial reduction between the laser and NaOCl or NaOCl alone groups . [ Correction added after online publication , 18th April 2012 : The following statement has been deleted : ' Thus , the use of a laser did not improve microbial killing over and above use of NaOCI alone . ' ]",
"Abstract Objective . Intra-canal post systems are commonly used to restore root-filled teeth . Bond strengths of the posts can be affected by various surface treatments of the post or the dentin . The aim of this study was to evaluate the effects of dentin surface treatments including erbium-chromium ; yttrium-sc and ium-gallium-garnet ( Er , Cr : YSGG ) laser irradiation with different intensities on the push-out bond strength of the glass fiber posts to root dentin . Material s and methods . Forty single-rooted human maxillary incisors were filled and post spaces were prepared . After these procedures , the specimens were divided r and omly into four groups according to the dentin surface treatments , as follows : ( i ) untreated surface ( control ) , ( ii ) 1W Er , Cr : YSGG laser application , ( iii ) 2W Er , Cr : YSGG laser application and ( iv ) 3W Er , Cr : YSGG laser application . Then the posts were cemented into the root canals using dual-cured resin cement . Bonded specimens were cut into 1-mm-thick slices and push-out tests were performed using a universal testing device . All specimens were loaded until fracture and the failure modes were evaluated with a stereomicroscope at 32 × magnification . Representative specimens were analyzed by scanning electron microscopy . Data were analyzed using a one-way ANOVA , Tukey and Wilcoxon tests . Results . The bond strength values ranged from 3.22–4.68 MPa . There were no statistically significant differences among the groups , regardless of the different levels . The coronal and middle levels of the post space had significantly higher bond strength values compared with the apical level ( p Conclusion . Er , Cr : YSGG laser irradiation with different intensities did not increase the bond strength of the fiber posts to the root canal dentin walls",
"The study aim ed to evaluate the effect of various final irrigant activation protocol s on push-out bond strength of fiber post . Thirty-two single-rooted human maxillar central teeth were sectioned below the cementoenamel junction , instrumented and obturated . Post-space preparation was performed , and roots were r and omly divided into eight groups ( n = 4 ) according to the final irrigant activation protocol s ; distilled water was used as an irrigant in group 1 . The other groups were treated with 2.5 % NaOCl and 17 % EDTA . Conventional syringe irrigation ( CSI , no activation ) was used in group 2 . Irrigation solutions were activated using passive ultrasonic irrigation ( PUI , group 3 ) , EndoVac apical negative pressure ( ANP , group 4 ) , diode laser ( group 5 ) , neodymium : yttrium – aluminum-garnet ( Nd : YAG ) laser ( group 6 ) , erbium : yttrium – aluminum-garnet ( Er : YAG ) laser ( group 7 ) , and Er : YAG laser using with photon-induced photoacoustic streaming ( PIPS ™ ) technique ( group 8) . In all groups , fiber posts ( White Post DC , FGM ) were luted using Panavia F 2.0 ( Kuraray , Osaka , Japan ) . The specimens were transversally sectioned , and all slices from coronal and apical regions were subjected to push-out tests . The data were calculated as megapascals and analyzed by using two-way analysis of variance followed by post hoc Tukey honestly significant difference ( HSD ) tests . Removing the smear layer increased the bond strength to dentine when compared with the control group ( p highest bond strength was obtained in the PIPS laser-activated irrigation group ( p Coronal root region presented significantly higher bond strength than the apical region ( p laser-activated irrigation showed higher efficiency as a final irrigant activation protocol on push-out bond strength of fiber post",
"OBJECTIVE This study tested the hypothesis that the stress distribution and bond strength of glass posts to intraradicular dentin is influenced by the mechanical testing methodology . METHODS Thirty single rooted endodontically treated teeth were prepared for luting of tapered fiber-glass posts ( Reforpost , Angelus , Londrina , PR , Brazil ) with a conventional adhesive system and resin luting cement ( Adper Scotchbond Multi- purpose , Rely X ARC , 3 M ESPE , St. Paul , MN , USA ) . The teeth were r and omly divided ( n=10 per group ) into micro-push-out ( Mpo ) , hourglass- ( Mh ) and rectangular stick-shaped ( Ms ) microtensile testing groups before sectioning each root into five 1-mm-thick specimens . During specimen preparation for microTBS testing 46/50 stick and 4/50 hourglass specimens prematurely failed ; therefore , the Ms group could not be included in the mechanical testing . The remaining specimens were tested at 0.5 mm/min until bond failure . Stress distribution within each specimen type for the three mechanical test methods was analyzed by finite element analysis ( FEA ) . Qualitative analyses were carried out through Von Mises , XY and Sy criterion . RESULTS Mpo and Mh had a mean microTBS of 11.89+/-6.55 and 14.98+/-12.72 MPa , respectively , which was not significantly different ( p=0.1311 ) . The push-out test demonstrated a more homogenous stress distribution by FEA and less variability in mechanical testing . SIGNIFICANCE Therefore , the recommended testing method for determining the bond strength of glass posts to intraradicular dentin is by Mpo",
"STATEMENT OF PROBLEM Resin cements are widely used to cement intraradicular posts , but bond strength is significantly influenced by the technique and material used for cementation . PURPOSE The purpose of this study was to evaluate the bond strength of 3 self-adhesive cements used to cement intraradicular glass fiber posts . The cements all required different application and h and ling techniques . MATERIAL AND METHODS Forty-five human maxillary canines were selected and r and omly divided into 3 groups n= 15 by drawing lots : Group BIS - Biscem , Group BRE - Breeze , and Group MAX - Maxcem . Each group was divided into 3 subgroups according to application and h and ling techniques : Sub-group A - Automix/Point tip applicator , Sub-group L - H and mix/Lentulo , and Sub-group C - H and mix/Centrix . Cementation of the posts was performed according to the manufacturers ' instructions . The push-out test was performed with a crosshead speed of 0.5 mm/min , and bond strength was expressed in megapascals . The results were evaluated by 2-way ANOVA and the all pairwise multiple comparison procedures ( Tukey test ) ( α=.05 ) . RESULTS Breeze cement showed the highest average for the subgroups A , L , and C when compared to the Biscem cement and Maxcem Elite ( P h and ling techniques may influence the bond strength of different self-adhesive cements when used for intraradicular post cementation",
"Background : Fiber reinforced composite ( FRC ) posts are cemented with resin cements . It is reported that using resin cements in canals sealed with eugenol-containing sealers reduces the post retention . However , there is controversy on the subject . Aims : The aim was to investigate the influence of eugenol-containing sealers and the amount of dentin removal from root canal with different post diameters on retention of FRC posts . Setting s and Design : It was an in vitro study Material s and Methods : The roots of sixty teeth were cut with 14 mm distance from the apex and were instrumented to the working-length of 13 mm . The teeth were r and omly distributed into 2 groups ( n = 30 ) . Following storage in normal saline for 7 days , the sample s in both the groups were further divided into 3 subgroups ( n = 10 ) . Canals in the experimental subgroups ( I , II , III ) were obturated by gutta-percha and eugenol-containing sealer ; and in the control subgroups ( IV , V , VI ) without any sealer . After storage in normal saline for 7 days , the post space was prepared by # 3 , # 2 , and # 1 drills of DT Light-Post system . Post was cemented with Panavia-F2.0 resin-cement . A composite core was built for each sample . All sample s were thermo cycled for 1000 cycles . The sample s were tested for post retention with a mechanical testing machine . Statistical Analysis : Data were analyzed by two-way ANOVA and Tukey-HSD test . Results : There was not a significant difference in retention between FRC posts # 1 and # 2 ( P > 0.05 ) . Post # 3 was more retentive than posts # 1 and # 2 ( P ZOE sealer significantly reduced the retention of posts ( P = 0.024 ) , however , increasing post-space diameter significantly increased post retention in canals coated with ZOE sealer ( P = 0.002 ) . Conclusions : Eugenol-containing sealer reduced the retention of FRC posts cemented with resin cement . Removing more dentin from root-canals treated with eugenol-containing sealer for placing larger diameter posts caused an increase in post retention"
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BACKGROUND Fluoride released from glass ionomer cements ( GICs ) is capable of preventing caries lesions . However , the preventive effect in margins of occlusal and occlusoproximal restorations have not been proved . The aim of this study was to evaluate the ability of GIC to prevent caries lesions in margins of occlusal and occlusoproximal restorations in primary teeth compared with that of other restorative material s. TYPES OF STUDIES REVIEW ED The authors conducted a literature search in PubMed and MEDLINE to verify the clinical trials available on the outcome of caries lesions . The inclusion criteria were that the subject related to the scope of this systematic review , the study had a follow-up , and the study was not performed in specific groups . The authors performed all meta-analyses by considering the secondary caries rates for the restorations in clinical trials . RESULTS The search strategy identified 450 potentially relevant studies , and the authors included 8 of them in the review . The main reasons for exclusion were that the studies were not related to the scope of this review or were not longitudinal trials . The secondary caries rate of the occlusal restorations was not different among the restorative material s ( odds ratio , 1.2 ; 95 % confidence interval , 0.5 - 3.1 ) . For occlusoproximal analysis , GIC was associated significantly with better ability to prevent caries lesions ( odds ratio , 1.7 ; 95 % confidence interval , 1.2 - 2.5 ) . CONCLUSIONS AND PRACTICAL IMPLICATION S Because new caries lesions in the margins of restorations are the main reason for failure and replacement of restorations in primary teeth , it is important to know whether there is a benefit in using GICs in both occlusal and occlusoproximal cavities
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[
"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",
"BACKGROUND The authors clinical ly examined two restorative material s to evaluate their effectiveness in Class II restorations in primary molars and their ability to inhibit recurrent caries . METHODS Forty subjects , each in need of two Class II restorations in primary molars , took part in this study . Each patient received one Class II restoration of resin-modified glass ionomer cement and one of amalgam . The authors evaluated the restorations at six-month , one-year , two-year and three-year recall appointments . On exfoliation , teeth with experimental restorations were retrieved and microscopically examined for inhibition of demineralization at restoration margins . RESULTS The results of the clinical evaluation demonstrated no significant differences between the resin-modified glass ionomer cement restorations and the amalgam restorations ( P resin-modified glass ionomer cement had significantly less enamel demineralization at restoration margins than did amalgam ( P resin-modified glass ionomer cement functioned clinical ly as well as amalgam for Class II restorations in primary molars . However , the resin-modified glass ionomer exhibited significantly less enamel demineralization at restoration margins than did amalgam . CLINICAL IMPLICATION S Resin-modified glass ionomer cement restorative material functions well for Class II restorations in primary molars and exhibits less recurrent caries at restoration margins than does amalgam",
"OBJECTIVES To assess and compare the cumulative survival rate of amalgam and atraumatic restorative treatment ( ART ) restorations in primary molars over 3 years . METHODS 280 children aged 6 - 7 years old were enrolled in a cluster r and omized controlled clinical trial using a parallel group design covering two treatment groups : conventional restorative treatment with amalgam ( CRT ) and atraumatic restorative treatment ( ART ) using a high-viscosity glass-ionomer ( HVGIC ) Ketac Molar Easymix . Three pedodontists placed 750 restorations ( 364 amalgam and 386 ART in 126 and 154 children , respectively ) which were evaluated at 0.5 , 1 , 2 and 3 years . The proportional hazard rate regression model with frailty correction , ANOVA and Wald tests , and the Jackknife procedure were applied in analysing the data . RESULTS The cumulative survival rates over 3 years for all , single- and multiple-surface CRT/amalgam restorations ( 72.6 % , 93.4 % , 64.7 % , respectively ) were no different from those of comparable ART/HVGIC restorations ( 66.8 % ; 90.1 % and 56.4 % , respectively ) ( p=0.10 ) . Single-surface restorations had higher survival rates than multiple-surface restorations for the both treatment procedures ( p failed because of mechanical reasons ( 94.8 % ) than of secondary caries ( 5.2 % ) . No difference in reasons for restoration failures between all types of amalgam and ART/HVGIC restorations were observed ( p=0.24 ) . SIGNIFICANCE The high-viscosity glass-ionomer used in this study in conjunction with the ART is a viable option for restoring carious dentin lesions in single surfaces in vital primary molars",
"This in vitro study evaluated the bond strength of adhesive restorative material s to sound and eroded dentin . Thirty-six bovine incisors were embedded in acrylic resin and ground to obtain flat buccal dentin surfaces . Specimens were r and omly allocated in 2 groups : sound dentin ( immersion in artificial saliva ) and eroded dentin ( pH cycling model - 3 × / cola drink for 7 days ) . Specimens were then reassigned according to restorative material : glass ionomer cement ( KetacTM Molar Easy Mix ) , resin-modified glass ionomer cement ( VitremerTM ) or adhesive system with resin composite ( Adper Single Bond 2 + Filtek Z250 ) . Polyethylene tubes with an internal diameter of 0.76 mm were placed over the dentin and filled with the material . The microshear bond test was performed after 24 h of water storage at 37ºC. The failure mode was evaluated using a stereomicroscope ( 400 × ) . Bond strength data were analyzed with two-way ANOVA and Tukey 's post hoc tests ( α = 0.05 ) . Eroded dentin showed bond strength values similar to those for sound dentin for all material s. The adhesive system showed the highest bond strength values , regardless of the substrate ( p the adhesive/mixed failure prevailed . In conclusion , adhesive material s may be used in eroded dentin without jeopardizing the bonding quality . It is preferable to use an etch- and -rinse adhesive system because it shows the highest bond strength values compared with the glass ionomer cements tested",
"BACKGROUND Secondary caries or caries adjacent to restorations is the most frequent reason for replacement of dental restorations . Though , limited data is available on variables influencing the development of secondary caries in primary teeth . AIM To investigate risk factors for the development of secondary caries adjacent to direct composite restorations in primary teeth . DESIGN For this retrospective study , data of 2417 composite restorations , which were placed due to primary carious lesions , were considered . A total of 212 restorations failed due to secondary caries within a maximum observation period of 8 years . A control group was r and omly selected . Mann-Whitney U-test , binomial logistic regression with backward elimination and Cox regression with frailty model were performed ( P overall caries experience amounted to 6.3 dmft and 13.3 dmfs . 72.5 % of restorations failed within the first 2 years . Older children and children from families with a higher socio-economic status showed a lower risk for secondary caries . Further , the dentist and the adhesive had a significant influence on the longevity . Posterior restorations had a higher risk to fail in comparison with anterior restorations . CONCLUSIONS Within the limitation of this study , it is concluded that the development of secondary caries is influenced by several factors . Nevertheless , the secondary caries rate was found to be relatively low in this high-risk population",
"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",
"OBJECTIVE The aim of this in vitro study was to evaluate the interaction between two sources of fluoride ( restorative systems and dentifrices ) in inhibiting artificial root caries development . METHODS One hundred and eighty tooth segments were embedded in polyester resin , and s and ed flat . Cylindrical cavities 1.0mm-deep and 1.5mm-diameter were prepared in root dentin and r and omly restored by fluoride-containing restorative systems : Ketac-fil/Espe ( Ke ) , Fuji II LC/GC Corp ( Fj ) , F2000/3 M ( F2 ) , Surefil/Dentsply ( Su ) or a control : Filtek Z250/3 M ( Z2 ) . Ten experimental groups were made to test the association among the five restorative systems and two dentifrices : with F(- ) ( Sensodyne Baking Soda ) or without F(- ) ( Sensodyne Original ) ( n=18 ) . After surface polishing , a 1mm-wide margin around the restorations was demarcated and initial dentin surface Knoop microhardness values ( KHN(i ) ) were obtained . The specimens were su bmi tted to a pH-cycling model , and to applications of slurries of dentifrice . Afterwards the final dentin surface Knoop microhardness values ( KHN(f ) ) were measured . RESULTS The differences between KHN(i ) and KHN(f ) , and the covariate KHN(i ) were considered by the ANCOVA and Tukey 's test ( alpha=0.05 ) . The interaction between restorative system and dentifrice was statistically significant ( p=0.0026 ) . All restorative systems provided some protection against artificial caries challenge when associated with the fluoride-containing dentifrice treatment . The means ( st and ard deviation ) of reductions in Knoop hardness values for systems associated with the fluoride-containing dentifrice were : Ke : 40.0(1.02)(a ) , Fj : 41.9(1.02)(b ) , F2 : 43.3(1.04)(c ) , Su : 43.5(1.00)(c ) , Z2 : 44.0(1.02)(c ) ; and with the non-fluoride-containing dentifrice were : Ke : 42.9(1.02)(a ) , Fj : 44.7(1.01)(b ) , F2 : 45.2(1.09)(bc ) , Su : 46.0(0.99)(c ) , Z2 : 46.6(0.99)(c ) ( statistical differences were expressed by different letters ) . CONCLUSION The cariostatic effect shown by the fluoride-containing dentifrice could enhance that shown by Ketac-fil and Fuji II LC , and could mask that shown by F2000",
"PURPOSE The authors conducted a r and omized clinical trial to evaluate the survival rate of esthetic restorations in Class I and Class II beveled preparations in primary molars 24 months after placement . The None hypothesis was that there is no difference among survival rates of the restorative material s used . METHODS Forty-eight children ( mean age , 5 years 9 months ) received 141 restorations in beveled cavosurface margins in primary molars r and omly assigned by lottery method : 46 received treatment with Vitremer Tri-Cure Glass Ionomer System ( 3 M ESPE Dental Products , St. Paul , Minn. ) ( 33 Class I and 13 Class II restorations ) , 51 received treatment with Freedom ( SDI , Bayswater , Victoria , Australia ) ( 36 Class I and 15 Class II restorations ) ; 44 received treatment with TPH Spectrum ( Dentsply , Petropolis , Rio de Janeiro , Brazil ) ( 30 Class I and 14 Class II restorations ) . Two examiners whose technique had been calibrated ( weight kappa > 0.85 ) evaluated the restorations using modified U.S. Public Health Service criteria and Visible Plaque Index score at baseline and at 12 , 18 and 24 months . RESULTS After two years , the authors censored data for 17 restorations , considered 101 restorations to be clinical ly successful and deemed 23 restorations failed because of loss of marginal integrity , anatomical form discrepancies and secondary caries . For Class I and Class II restorations , the cumulative survival rates were higher than 80 percent and 55 percent , respectively , for all material s ( life table , Gehan-Wilcoxon Test , P > .05 ; P > .05 ) . CONCLUSIONS At the 24-month clinical recall , the authors found no differences among material s in Class I ( P > .05 ) or Class II beveled preparations ( P > .05 ) in primary molars , but all material s showed higher survival rates in Class I than in Class II 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",
"The purpose of this study was to compare the clinical efficacy of resin modified GIC with amalgam as a restorative material , in Class-II cavities of primary molars . Restorations were evaluated at four , eight , and twelve months for their marginal integrity , anatomic form and development of recurrent caries . When each parameter was considered separately , there was no difference in the success rate between the two groups , except development of recurrent caries significantly less ( p cumulative success rate at 12 month was found to be significantly higher ( p ( Fuji II LC ) group(83.1 % ) compared to amalgam(72 % )",
"Background : Although Atraumatic restorative treatment ( ART ) approach has been in existence for a while , the reasons for the poor performance of multisurface ART restorations are not very clear . Aim : The aim of this study is to investigate the effects of oral hygiene , residual caries and cervical marginal-gaps on survival of proximal ART restorations . Setting s : Two rural divisions in Kenya were selected for the study . Design : A r and omized clinical trial . Material and Methods : The 804 children in the study had their baseline- and 2-year dental plaque levels documented . Each child received one proximal restoration in a primary molar using ART approach , together with trained and pre-tested operators/assistants , three glass ionomer cements (GIC)-br and s and two tooth-isolation methods . The restorations were clinical ly evaluated soon after placement and after 2 years . Post-restorative bite-wing radiographs taken soon after restoration were also evaluated . Statistical analysis : Statistical Package for Social Sciences ( SPSS ) version 14 computer programme was used and results tested using Pearson 's correlation , Cox Proportional Hazards regression analysis and Multiple Logistic regression models tests . Results : At baseline and after 2 years , the mean cumulative survival and plaque index changed from 94.4 % to 30.8 % and 2.34 ( St and ard Deviation , or SD of 0.46 ) to 1.92 ( SD 2.1 ) respectively , with higher plaque indices associated with higher restoration failures . Of the 507 radiographs evaluated , 48 ( 9.5 % ) , 63 ( 12.4 % ) and 9 ( 1.8 % ) restorations had residual caries ( RC ) , cervical marginal-gaps ( CMG ) and both RC/CMG respectively . Survival of the restorations with RC/CMG was significantly lower ( p = 0.003 ) compared to those with RC or without RC . Conclusion : Low survival of proximal restorations in the study was associated with the presence of cervical marginal-gaps",
"Objective . To evaluate the clinical durability of flowable resin composite and resin-modified glass ionomer cement when used as class II restoratives in primary molars . Material and Methods . A total of 190 restorations were placed in 61 children , age in the range of 5–11 years . The restoratives , Tetric Flow , in combination with the adhesives , Excite or Prompt-L-Pop and Vitremer , were used in class II cavities in primary molars . An intra-individual study design was used and the restorations were evaluated by modified USPHS criteria over a 2-year period . Results . 146 of the restorations could be evaluated at 2 years . The cumulative failure rate was 10.6 % for Vitremer and 13.6 % for Tetric Flow . No statistically significant differences were found in failure rates between different material s or between bonding systems . The main cause of failure for Tetric Flow was secondary caries and for Vitremer wear and dissolution . Conclusions . Vitremer and Tetric Flow showed no significant difference concerning clinical durability at 2 years when used as class II restoratives in primary molars . Both material s demonstrated acceptable clinical results ",
"The aim of the present investigation was to study the prevalence of approximal caries lesions and fillings in posterior teeth at 15 years of age in a prospect ively followed Swedish population ( n = 568 ) , with special reference to their caries experience at the age of 3 years . Only approximal surfaces were recorded , since all children in the Community of Jönköping have had fissure sealing performed on all caries-free permanent molars . At 15 years of age , the mean number of approximal tooth surfaces with initial caries lesions ( Dia ) , manifest caries lesions and fillings ( DmFa ) and total caries experience and fillings ( Di + mFa ) – recorded on bitewing radiographs – was 2.78 , 0.45 and 3.23 , respectively . One third of the adolescents had no approximal caries or fillings ; the Dia constituted 86 % of the Di + mFa . Children with manifest caries at 3 years of age had a higher risk of developing approximal caries in their permanent teeth than caries-free children at the same age ( 41 vs. 17 % ) . Furthermore , children who were caries-free at 3 years of age were more likely to remain caries-free at 15 years of age compared to children with manifest caries ( 37 vs. 17 % ) . All these differences were statistically significant ( p early childhood caries experience ( developed before 3 years of age ) had a greater predictive value than late childhood caries experience ( developed between 3 and 6 years of age ) concerning approximal caries at 15 years of age",
"PURPOSE To evaluate the clinical performance of adhesive restorations of resin composite and resin-modified glass-ionomer cements in primary molars . METHODS This r and omized clinical trial included subjects ( 5 - 9 year-old children ) selected at two university centers ( UFRGS and UNIFRA ) . The sample consisted of 132 primary molars presenting active cavitated carious lesions ( with radiographic involvement of the inner half of the dentin ) , located on the occlusal and occlusal-proximal surface . The sample was r and omly divided into three groups , according to the restorative material : ( G1 ) universal restorative system ( Adper Single Bond 2 system and Filtek Z350 ) ; ( G2 ) : Resin-modified glass-ionomer cement ( Vitremer ) ; and ( G3 ) : Low shrink restorative system ( Filtek P90 ) . The restorations were clinical ly and radiographically followed every 6 months for up to 18 months using the USPHS modified criteria for clinical evaluation . Survival estimates for restoration longevity were evaluated using the Kaplan-Meier method . Log-rank test ( P success rate according to the type of the restorative material . RESULTS The type of restorative material used did not influence the longevity of the restorations . After clinical follow-up , there was no statistical difference in the rates of success for the three material s used to restore active cavitated carious lesions in primary molars . The survival rates for the follow-up were similar regarding the number of restored surfaces and the caries removal technique ( partial or complete ) . Mean estimated time of survival was 17.2 months ( 95 % CI : 16.7 - 17.7 ) . Estimated survival rates of the restorations were 100 % , 98 % , 88 % and 65 % at 1 , 6 , 12 and 18 months of clinical evaluations , respectively"
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41173048-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVE Home telemonitoring represents a patient management approach combining various information technologies for monitoring patients at distance . This study presents a systematic review of the nature and magnitude of outcomes associated with telemonitoring of four types of chronic illnesses : pulmonary conditions , diabetes , hypertension , and cardiovascular diseases . METHODS A comprehensive literature search was conducted on Medline and the Cochrane Library to identify relevant articles published between 1990 and 2006 . A total of 65 empirical studies were obtained ( 18 pulmonary conditions , 17 diabetes , 16 cardiac diseases , 14 hypertension ) mostly conducted in the United States and Europe . RESULTS The magnitude and significance of the telemonitoring effects on patients ' conditions ( e.g. , early detection of symptoms , decrease in blood pressure , adequate medication , reduced mortality ) still remain inconclusive for all four chronic illnesses . However , the results of this study suggest that regardless of their nationality , socioeconomic status , or age , patients comply with telemonitoring programs and the use of technologies . Importantly , the telemonitoring effects on clinical effectiveness outcomes ( e.g. , decrease in the emergency visits , hospital admissions , average hospital length of stay ) are more consistent in pulmonary and cardiac studies than diabetes and hypertension . Lastly , economic viability of telemonitoring was observed in very few studies and , in most cases , no in-depth cost-minimization analyses were performed . CONCLUSION Home telemonitoring of chronic diseases seems to be a promising patient management approach that produces accurate and reliable data , empowers patients , influences their attitudes and behaviors , and potentially improves their medical conditions . Future studies need to build evidence related to its clinical effects , cost effectiveness , impacts on services utilization , and acceptance by health care providers
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"BACKGROUND Heart failure treatment guidelines emphasize daily weight monitoring for patients with heart failure , but data to support this practice are lacking . Using a technology-based heart failure monitoring system , we determined whether daily reporting of weight and symptoms in patients with advanced heart failure would reduce rehospitalization and mortality rates despite aggressive guideline -driven heart failure care . METHODS This was a r and omized , controlled trial . Patients hospitalized with New York Heart Association class III or IV heart failure , with a left ventricular ejection fraction receive heart failure program care or heart failure program care plus the AlereNet system ( Alere Medical , Reno , Nev ) and followed-up for 6 months . The primary end point was 6-month hospital readmission rate . Secondary end points included mortality , heart failure hospitalization readmission rate , emergency room visitation rate , and quality of life . RESULTS Two hundred eighty patients from 16 heart failure centers across the United States were r and omized : 138 received the AlereNet system and 142 received st and ard care . Mean age was 59 + /- 15 years and 68 % were male . The population had very advanced heart failure , New York Heart Association class III ( 75 % ) or IV ( 25 % ) , as evidence d by serum norepinepherine levels , 6-minute walk distance and outcomes . No differences in hospitalization rates were observed . There was a 56.2 % reduction in mortality ( P patients with advanced heart failure . Despite no difference in the primary end point of rehospitalization rates , mortality was significantly reduced for patients r and omized to the AlereNet system without an increase in utilization , despite specialized and aggressive heart failure care in both groups",
"Education programs for intensive insulin therapy were found to be valuable in improving glycemic control , but , due to low prevalence of type 1 diabetes in children and adolescents , access to those programs varies considerably in rural areas . We report on a telemedical care program that overcomes geographical isolation of patients on intensive insulin therapy . Sixty-one children and adolescents under the age of 26 participated in a telemedical care program . They stored daily information on blood glucose , injected insulin , meals and exercise in a glucosemeter with electronic memory and transferred the data via modem go a remote diabetes center outside of the region . By individual telephone consultations from home , they review ed the data with a diabetologist at the diabetes center and adjusted their intensive insulin therapy in order to achieve predefined treatment goals . Patients were trained for 19 ( 6 - 48 ) weeks in the program and measured blood glucose 4.9 ( 1.7 - 4.9 ) times daily . Compared to the run-in-period , mean blood glucose had decreased ( 167 to 158 mg/dL , p st and ard deviation of blood glucose had decreased ( 81 to 70 mg/dL , p frequency of hypoglycemia had decreased ( 5.2 to 3.3 in 4 weeks , p = 0.01 ) at the end of the program . The proportion of blood glucose values within the target range ( 80 - 180 mg/dL ) had increased ( 47 - 55 % , p HbAlc was reduced by 0.4 % ( -3.8 to + 2.2 % , p care for intensive insulin therapy is safe , can improve glycemic control , and reduce the number of hypoglycemias in children and adolescents with type 1 diabetes",
"PURPOSE Self-monitoring of blood glucose has become routine practice in the management of diabetes mellitus . When all the data is complete , however , the amount of information to be taken into account when making therapeutic decisions becomes overwhelming not only for the patient but for the healthcare provider . Computers excel at processing large amounts of information quickly and impassively , which makes them potentially helpful for collating and communicating the data in a manner that facilitates decision-making by patient and healthcare provider . This should in turn improve control and help prevent acute and chronic complications . METHOD Using the Vista 350 telephone , we have developed a system that enables patients with diabetes to record home monitoring data to a central data base and receive feedback summaries . A small trial was conducted to determine if the Vista 350 telephone is an acceptable and feasible method to communicate the results of home monitoring of diabetes mellitus to a central data base and receive feedback summaries . A total of 35 volunteers with insulin-requiring diabetes mellitus in the London area were r and omly allocated to either use the Vista 350 phone for 6 months , or to a control group that continued to use traditional methods for recording home monitoring data . RESULTS 33 of the 35 patients enrolled completed the trial . All 16 patients who began using the phone continued to do so for 6 months confirming the feasibility of the system . Question naires completed at 3 and 6 months confirmed the Vista 350 telephone system to be acceptable to the subjects . The results will enable some minor modifications to be made to the telephone system before a larger definitive trial , design ed to determine the effect on diabetes control , is conducted later this year",
"No \" white coat \" effect contaminated the validity of measurements in 30 participants in a \" Telepress \" program , in which subscribers to a telecardiologic facility transtelephonically transmit their self-measured blood pressure values ",
"OBJECTIVES We sought to identify whether home telemonitoring ( HTM ) improves outcomes compared with nurse telephone support ( NTS ) and usual care ( UC ) for patients with heart failure who are at high risk of hospitalization or death . BACKGROUND Heart failure is associated with a high rate of hospitalization and poor prognosis . Telemonitoring could help implement and maintain effective therapy and detect worsening heart failure and its cause promptly to prevent medical crises . METHODS Patients with a recent admission for heart failure and left ventricular ejection fraction ( LVEF ) were assigned r and omly to HTM , NTS , or UC in a 2:2:1 ratio . HTM consisted of twice-daily patient self-measurement of weight , blood pressure , heart rate , and rhythm with automated devices linked to a cardiology center . The NTS consisted of specialist nurses who were available to patients by telephone . Primary care physicians delivered UC . The primary end point was days dead or hospitalized with NTS versus HTM at 240 days . RESULTS Of 426 patients r and omly assigned , 48 % were aged > 70 years , mean LVEF was 25 % ( SD , 8) and median plasma N-terminal pro-brain natriuretic peptide was 3,070 pg/ml ( interquartile range 1,285 to 6,749 pg/ml ) . During 240 days of follow-up , 19.5 % , 15.9 % , and 12.7 % of days were lost as the result of death or hospitalization for UC , NTS , and HTM , respectively ( no significant difference ) . The number of admissions and mortality were similar among patients r and omly assigned to NTS or HTM , but the mean duration of admissions was reduced by 6 days ( 95 % confidence interval 1 to 11 ) with HTM . Patients r and omly assigned to receive UC had higher one-year mortality ( 45 % ) than patients assigned to receive NTS ( 27 % ) or HTM ( 29 % ) ( p = 0.032 ) . CONCLUSIONS Further investigation and refinement of the application of HTM are warranted because it may be a valuable role for the management of selected patients with heart failure",
"OBJECTIVE To evaluate the effectiveness of at-home infrared temperature monitoring as a preventative tool in individuals at high risk for diabetes-related lower-extremity ulceration and amputation . RESEARCH DESIGN AND METHODS Eighty-five patients who fit diabetic foot risk category 2 or 3 ( neuropathy and foot deformity or previous history of ulceration or partial foot amputation ) were r and omized into a st and ard therapy group ( n = 41 ) or an enhanced therapy group ( n = 44 ) . St and ard therapy consisted of therapeutic footwear , diabetic foot education , and regular foot evaluation by a podiatrist . Enhanced therapy included the addition of a h and held infrared skin thermometer to measure temperatures on the sole of the foot in the morning and evening . Elevated temperatures ( > 4 degrees F compared with the opposite foot ) were considered to be \" at risk \" of ulceration due to inflammation at the site of measurement . When foot temperatures were elevated , subjects were instructed to reduce their activity and contact the study nurse . Study subjects were followed for 6 months . RESULTS The enhanced therapy group had significantly fewer diabetic foot complications ( enhanced therapy group 2 % vs. st and ard therapy group 20 % , P = 0.01 , odds ratio 10.3 , 95 % CI 1.2 - 85.3 ) . There were seven ulcers and two Charcot fractures among st and ard therapy patients and one ulcer in the enhanced therapy group . CONCLUSIONS These results suggest that at-home patient self-monitoring with daily foot temperatures may be an effective adjunctive tool to prevent foot complications in individuals at high risk for lower-extremity ulceration and amputation",
"BACKGROUND Outcomes related to chronic heart failure ( HF ) remain relatively poor , despite advances in pharmacological therapy and medical and nursing care . Experts agree that outpatient care may be among the factors that affect HF outcomes . We hypothesized that the method by which outpatient care is delivered may affect outcomes in this patient population . METHODS A prospect i ve , r and omized design was used to compare HF outcomes from 216 patients r and omized to 1 of 2 home health care delivery methods for 3 months after discharge . Care was delivered by the home nurse visit ( HNV ) or the nurse telemanagement ( NTM ) method . In the latter , patients used transtelephonic home monitoring devices to measure their weight , blood pressure , heart rate , and oxygen saturation . These data were transmitted daily to a secure Internet site . An advanced- practice nurse worked collaboratively with a cardiologist and subsequently treated patients via the telephone . Both delivery methods used the same HF-specific clinical guidelines to direct care . Outcomes include HF readmissions and length of stay , anxiety , depression , self-efficacy , and quality of life . Data were primarily tested using a 2-group analysis of variance ( ANOVA ) . We used a repeated- measures ANOVA to conduct preintervention-postintervention analyses . RESULTS After 3 months , patients in the NTM group ( n = 108 ; mean + /- SD age , 62.9 + /- 13.2 years ; 83 % African American ; 64 % female ) had fewer HF readmissions ( 13 vs 24 ; P lengths of stay ( 49.5 vs 105.0 days ; P HNV group ( n = 108 ; mean + /- SD age , 63.2 + /- 12.6 years ; 89 % African American ; 62 % female ) . Hospitalization charges at 3 months were less in the NTM group compared with the HNV group ( $ 65 023 vs $ 177 365 ; P cumulative readmission charges in the NTM group were also less ( $ 223 638 vs $ 500 343 [ P Quality of life was significantly improved for both groups when we compared postintervention and preintervention scores . CONCLUSION The adaptation of state-of-the-art computerized technology to closely monitor patients with HF with advanced- practice nurse care under the guidance of a cardiologist significantly improves HF management while reducing the cost of care",
"We assessed the utilization of health-care services and clinical outcomes in veterans with diabetes who were enrolled in two care coordination/home telehealth programmes . One group of patients was monitored weekly ( n = 197 ) , with more intensive evaluations , while the other was monitored daily ( n = 100 ) , but less intensively . Although patients in the two groups were fairly similar in demographic terms and in their clinical characteristics at baseline , they had different service utilization patterns during the 12-month pre-enrollment period . Over the 12-month study period , the proportion of one or more hospital admissions and number of bed days of care decreased in the daily monitoring group , and increased in the weekly monitoring group , more or less doubling in the former and being halved in the latter . Unscheduled primary care clinic visits were lower in the daily monitored group than in the weekly monitored group . The differences between the two groups were significant ( P < 0.01 ) . There were no significant differences between the groups in the clinical outcomes . Future research should employ r and omized controlled trial design s to determine if intensities of home monitoring lead to differences in service utilization and health outcomes",
"This is a controlled pilot study of twenty patients to see if heart failure management can be optimised in the community using telemedicine . The study seeks to examine the feasibility , acceptability and reliability of using telemedicine in this context . Heart failure is a common condition . It is an important cause of mortality and morbidity and has large cost implication s for the NHS . Most patients are managed in the UK in General Practice based on clinical assessment by the practitioner . Twenty patients with a mean age of 75.1 years and mean New York Heart Association grade of 1.75 were r and omised in to two equal groups ( telemonitoring and control ) and observed for a period of three months . All twenty patients had a Cardiologist assessment and quality of life measurement at the beginning and end of the study . Patients in the telemedicine group had their blood pressure , pulse and weight data collected daily and undertook a weekly video conference with the nurse . Control patients had their blood pressure , weight and pulse measured at six weekly intervals . The study has been extended for a further six months beyond its initial three-month observation period to see if the initial short term benefit in the telemedicine group is maintained",
"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",
"OBJECTIVE To assess whether modem access improves diabetes control in IDDM patients . RESEARCH DESIGN AND METHODS Forty-two patients participated in the study and were followed for 12 wk . The patients were r and omly divided into two groups at baseline , a modem group and a control group . There were no significant differences between HbA1c , r and om blood glucose , and weight between the groups at the beginning of the study . Patients were asked to perform five blood glucose determinations/day ( before breakfast , before lunch , afternoon [ 1500 ] , before dinner , and at bedtime ) twice/week . The modem group transferred their data over the phone once/week . The control group would bring in their results on their regular visits every 6 wk . Patients in the modem group were counseled every week over the telephone after transferring results to adjust insulin and food intake if necessary . RESULTS In the modem group , HbA1c improved from 0.106 to 0.092 ( 13.20 % ) . The control group improved from 0.112 to 0.102 ( 8.9 % ) . There was no significant change in weight , r and om blood glucose , or insulin . CONCLUSIONS The use of telephone modem-based patient-monitoring systems in diabetes clinical research seems to stimulate the patient to keep closer control of blood glucose levels . It might be especially useful in rural setting s , for which this study was design ed",
"We conducted a six-month prospect i ve interventional crossover study examining a computerized diabetes monitoring system ( DMS ) that conveyed dietary information . The objectives were to compare glycaemic control between intervention and control periods , and to assess patients ' acceptance of the DMS . Nineteen patients were r and omized into two groups , each using the DMS for three months and serving as the control group for another three months . The patients recorded information about their meal portions and blood glucose readings in a h and -held electronic diary . After transmitting the data to the DMS through a telephone modem , the patients received immediate feedback about the carbohydrate , protein and fat content of the meal , as well as the calorie content . A significant improvement in glycaemic control was achieved during intervention compared with control periods ( mean HbA1C reduction of 0.825 % ) . The DMS was also highly acceptable : 95 % patients found it easy to operate while 63 % found it useful . The DMS was thus a feasible model of telemedicine in diabetes care and a larger study is warranted to examine its cost-effectiveness",
"BACKGROUND Patients with chronic heart failure characteristically have multiple hospital admissions for symptom control , deleteriously affecting their quality of life and imposing a burden on national healthcare costs . We assessed the effect of a novel transtelephonic monitoring and follow-up program on the admission rate and length of hospital stay as well as changes in their subjectively rated quality of life of patients with chronic heart failure . METHODS This prospect i ve 1-year study was conducted on compliant subscribers to ' SHL ' , a telecardiological service with > 60,000 subscribers , who were admitted > or = 2 times during the previous year for recurrent pulmonary edema or deterioration in heart failure . Their heart rate , blood pressure and body weight measurements were now automatically transmitted daily to ' SHL\"s data bank and added to stored and up date d medical records . A question naire survey acquired information on their quality of life . RESULTS The study cohort included 118 patients , mean age 75 years ( range 49 - 89 years ) , 65 % males , a II-IV class functional capacity and a 25 % ( range 10 - 39 % ) mean ejection fraction . There was a 66 % reduction in the total hospitalization days ( from 1623 in the year preceding study entry to 558 during the study period , p quality of life . CONCLUSIONS Data are provided to demonstrate that a transtelephonic system allowing primary care at the patient 's home can significantly reduce hospitalization rate and length of stay and significantly enhance the quality of life of patients with chronic heart failure",
"Home monitoring by lung transplant recipients has been effective for early detection of clinical problems . This study used an electronic diary for home monitoring by lung transplant c and i date s to improve communication between c and i date s and the transplant team . C and i date s were r and omized into control ( 52 subjects following st and ard telephone reporting procedures ) and intervention ( 67 subjects using an electronic diary to record and transmit a range of health-related measures ) groups . Outcome measures were monitoring adherence and level of communication ( for monitor acceptability and utilization ) , hospital length of stay after transplantation and survival at 4 months ( for clinical effectiveness ) . Subjects used the diary without difficulty and with good adherence . Subjects and coordinator contacts were similar between groups ; intervention group subjects were positive regarding contact based on diary use . There were no significant differences in clinical outcomes between groups . Changing diary questions might improve the effectiveness of electronic monitoring for lung transplant c and i date",
"Objective To improve the analysis of self-monitoring of blood glucose ( SMBG ) and its communication between patients and physicians by a telematic transmission of computerized SMBG and to study the consequences of its use on glucose control of insulin-dependent diabetic ( IDDM ) patients . Research Design and Methods A prospect i ve r and omized crossover trial with two 3-mo periods , one with SMBG recorded on traditional booklets ( booklet period ) and another with computerized SMBG transmitted to a central data base through a telematic network ( telematic period ) , comprised the study . During the latter phase , patients could receive computerized SMBG analysis on individual terminals connected to the telephone network ( Minitel system ) . Blood glucose recordings and HbA1c were measured at inclusion and end of each period . Eleven pairs of IDDM patients on intensified insulin therapy were r and omized within each pair to start with the telematic period ( group A ) or the booklet period ( group B ) . Results Telematic transmissions were successful ( initial HbA1c was low ( 6.7 % ) , it declined during the telematic period ( Δ = -0.41 % ) compared with the booklet period ( Δ = + 0.37 % , P = 0.05 ) . The percentage of low ( correlated with HbA1c changes during the telematic period ( r = 0.714 , P= 0.0014 ) but not the booklet period . The patients favored the telematic tool to analyze SMBG . Conclusions Telematic transmission of SMBG is feasible . It can improve SMBG analysis and perhaps glucose control , therefore offering a new way of communication between diabetic patients and their physicians",
"BACKGROUND Experience from other fields of internal medicine shows that Internet-based technology can be used to monitor various diseases . The new technology h and les complex calculation programs easily , and it is a unique way of communicating . These advantages might be used in optimizing the treatment for asthmatic subjects because undertreatment is a common problem found in European asthmatic subjects . OBJECTIVE We sought to investigate the outcome of monitoring and treatment using a physician-managed online interactive asthma monitoring tool and to assess whether the outcome differs from that of monitoring and treatment in an outpatient respiratory clinic or in primary care . METHODS Three hundred asthmatic subjects were r and omized to 3 parallel groups in a 6-month prospect i ve study : ( 1 ) Internet-based monitoring ( n = 100 ) ; ( 2 ) specialist monitoring ( n = 100 ) ; and ( 3 ) general practitioner ( GP ) monitoring ( n = 100 ) . All the patients were examined on entry into the study and after 6 months of treatment . RESULTS The treatment and monitoring with the Internet-based management tool lead to significantly better improvement in the Internet group than in the other 2 groups regarding asthma symptoms ( Internet vs specialist : odds ratio of 2.64 , P = .002 ; Internet vs GP : odds ratio of 3.26 ; P quality of life ( Internet vs specialist : odds ratio of 2.21 , P = .03 ; Internet vs GP : odds ratio of 2.10 , P = .04 ) , lung function ( Internet vs specialist : odds ratio of 3.26 , P = .002 ; Internet vs GP : odds ratio of 4.86 , P airway responsiveness ( Internet vs GP : odds ratio of 3.06 , P = .02 ) . CONCLUSION When physicians and patients used an interactive Internet-based asthma monitoring tool , better asthma control was achieved",
"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",
"This study was conducted to evaluate the effect of automated telephone patient monitoring and counseling on patient adherence to antihypertensive medications and on blood pressure control . A r and omized controlled trial was conducted in 29 greater Boston communities . The study subjects were 267 patients recruited from community sites who were > or= 60 years of age , on antihypertensive medication , with a systolic blood pressure ( SBP ) of > or= 160 mm Hg and /or a diastolic blood pressure ( DBP ) of > or= 90 mm Hg . The study compared subjects who received usual medical care with those who used a computer-controlled telephone system in addition to their usual medical care during a period of 6 months . Weekly , subjects in the telephone group reported self-measured blood pressures , knowledge and adherence to antihypertensive medication regimens , and medication side-effects . This information was sent to their physicians regularly . The main study outcome measures were change in antihypertensive medication adherence , SBP and DBP during 6 months , satisfaction of patient users , perceived utility for physicians , and cost-effectiveness . The mean age of the study population was 76.0 years ; 77 % were women ; 11 % were black . Mean antihypertensive medication adherence improved 17.7 % for telephone system users and 11.7 % for controls ( P = .03 ) . Mean DBP decreased 5.2 mm Hg in users compared to 0.8 mm Hg in controls ( P = .02 ) . Among nonadherent subjects , mean DBP decreased 6.0 mm Hg for telephone users , but increased 2.8 mm Hg for controls ( P = .01 ) . For telephone system users , mean DBP decreased more if their medication adherence improved ( P = .03 ) . The majority of telephone system users were satisfied with the system . Most physicians integrated it into their practice s. The system was cost-effective , especially for nonadherent patient users . Therefore , weekly use of an automated telephone system improved medication adherence and blood pressure control in hypertension patients . This system can be used to monitor patients with hypertension or with other chronic diseases , and is likely to improve health outcomes and reduce health services utilization and costs",
"OBJECTIVE To determine whether automated measurement of blood pressure and pulse in a home setting can be easily accomplished by pregnant women with chronic hypertension . STUDY DESIGN In this prospect i ve investigation , seven women with chronic hypertension complicating pregnancy recorded their blood pressure at home twice a day . These data were offloaded once daily into a computer at a remote site , and a computerized printout of these data was received by the physician . RESULTS The patients participated in the study for 12.2 + /- 5.8 weeks ( range 4 to 18 weeks ) and were between 23 and 42 weeks ' gestation . Average mean arterial pressure in the home was 102 + /- 10 mm Hg , and average pulse was 81 + /- 11 beats per minute . In the clinic , the values were 112 + /- 13 mm Hg and 90 + /- 30 beats per minute ( p home blood pressure monitoring device was easy to use and correlated well with values recorded by health professionals for this limited number of subjects . It was particularly helpful to patients ( n = 5 ) who lived long distances ( more than 60 miles ) from the clinic and to women who needed adjustments of antihypertensive medication",
"Aim : To compare the accuracy of clinic blood pressure ( CBP ) and telemedical home blood pressure ( HBP ) measurement in the assessment of antihypertensive effect . Methods : 362 patients on antihypertensive medication performed HBP measurement ( 5 days , duplicate measurements , four times daily ) and ambulatory blood pressure ( ABP ) monitoring in r and om order . Main outcome measure was the agreement of CBP and HBP with daytime ABP . Results : CBP was much higher than ABP and average HBP ( p HBP over the course of the study , achieving the level of daytime ABP on the last 2 monitoring days . The correlation between CBP and ABP was weak ( systolic : r = 0.343 , diastolic r = 0.430 ) , whereas strong correlations existed between HBP and ABP ( systolic r = 0.804 , diastolic r = 0.776 ) . A progressive improvement in the strength of the correlation between average HBP of single days and ABP was obtained over the 5 monitoring days . The HBP readings taken in the afternoon showed a stronger correlation with ABP than the values measured in the morning , at noon and in the evening . Averaging more HBP readings taken on succeeding days result ed in a progressive improvement in the agreement with ABP with a further benefit when readings of day 1 were included . Conclusions : The accuracy of telemedical HBP measurement is substantially better than that of CBP . The results suggest , that HBP should be measured for 5 days , and afternoon measurements should be preferred in assessing control of hypertension",
"Patients with a diagnosis of heart failure , registered at the study practice , were recruited into the study . First , they had a cardiologist 's assessment . They were then r and omised into telemonitored patients who measured pulse , BP , weight and video consulted , and controls",
"BACKGROUND African Americans have a higher prevalence and greater severity of hypertension than do other minorities and whites . This fact is particularly problematic when one realizes that the rate of control and treatment of hypertension in the US population is getting worse rather than better . Alternative strategies to promote blood pressure control need to be tested . OBJECTIVES The purpose of this pilot study was to test the following hypothesis : Persons who participate in nurse-managed home telemonitoring ( HT ) plus usual care or who participate in nurse-managed community-based monitoring ( CBM ) plus usual care will have greater improvement in blood pressure from baseline to 3 months ' follow-up than will persons who receive usual care only . METHODS This study used a r and omized controlled design ; participants were r and omly assigned to 1 of 3 groups that were stratified by use or nonuse of antihypertension medication . One-way analysis of variance ( ANOVA ) and analysis of covariance ( ANCOVA ) controlling for age and body weight were used to determine changes in blood pressure from baseline to 3 months . The sample contained 26 African Americans with a mean age of 59 years . RESULTS Both the HT group and the CBM group had clinical ly and statistically significant ( P systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) at 3 months ' follow-up , with participants in the HT group demonstrating the greatest improvement ( HT : baseline SBP 148.8 + /- 13.8 , DBP 90.2 + /- 5.79 ; 3 months ' follow-up SBP 124.1 + /- 13.82 , DBP 75.58 + /- 11.4 ; CBM : baseline SBP 155.25 + /- 17.014 , DBP 89.42 + /- 10.95 ; 3 months ' follow-up SBP 142.3 + /- 12.1 , DBP 78.25 + /- 6.86 ) . There was little change in SBP or DBP at 3 months ' follow-up in the usual care only group . CONCLUSION These are important pilot results , which if replicated in a larger sample will significantly improve care for urban African Americans with hypertension",
"BACKGROUND Patients with insulin dependent diabetes require frequent advice if their metabolic control is not optimal . This study focuses on the fiscal and administrative aspects of telemanagement , which was used to establish a supervised autonomy of patients on intensified insulin therapy . METHODS A prospect i ve , r and omised trial with 43 patients on intensified insulin therapy was conducted . Travelling distance to the diabetes centre was 50 min one way ; all patients had undergone a diabetes education course with lessons in dose adaptation . Patients were r and omly assigned to telecare ( n=27 ) or conventional care ( n=16 ) . They used BG-meters with a storage capacity of 120 values ( Precision QID Abbott/Medisense ) and transmitted their data over a combined modem/interface via telephone line to the diabetes centre . Data were displayed and stored by a customised software ( Precision Link Plus , Abbott/Medisense ) . Advice for proper dose adjustment was given by telephone . RESULTS Average time needed for instruction in the telemedical system was 15 min . Data were transmitted every 1 - 3 weeks and a teleconsultation was performed by phone every 2 - 4 weeks , depending on the extent of specific problems . On average , personal visits in the control group were performed once a month . Physician 's time expenditure for telemanagement , compared to conventional advice was moderately higher ( 50 vs. 42 min per month ) . A substantial amount of time on the patients side could be saved through replacing personal communications by telephone contacts and data transmission reduction ( 96 vs. 163 min/month including data transmission time ) . Setting up an optimal telemanagement scenario , a cost analysis was carried out yielding savings of approximately 650 euro per year per patient . HbA(1c ) dropped significantly from 8.2 to 7.0 % after 8 months of observation , but there was no significant difference between the intervention and control groups . Major technical problems with the telematic system did not occur during the study . CONCLUSIONS Telemanagement of insulin-requiring diabetic patients is a cost and time saving procedure for the patients and results in metabolic control comparable to conventional outpatient management",
"Home peak expiratory flow ( PEF ) measurement is recommended by asthma guidelines . In a 16-week r and omized controlled study on 16 subjects with asthma ( 24.6 6.5 years old , asthma duration small ze , Cyrillic 6 months ) , we examined Global System for Mobile Communications ( GSM ) mobile telephone short-message service ( SMS ) as a novel means of telemedicine in PEF monitoring . All subjects received asthma education , self-management plan , and st and ard treatment . All measured PEF three times daily and kept a symptom diary . In the study group , therapy was adjusted weekly by an asthma specialist according to PEF values received daily from the patients . There was no significant difference between the groups in absolute PEF , but PEF variability was significantly smaller in the study group ( 16.12 + /- 6.93 % vs. 27.24 + /- 10.01 % , p = 0.049 ) . forced expiratory flow in 1 second ( FEV1 ; % predicted ) in the study group was slightly but significantly increased ( 81.25 + /- 17.31 vs. 77.63 + /- 14.80 , p = 0.014 ) and in the control group , unchanged ( 78.25 + /- 21.09 vs. 78.88 + /- 22.02 , p = 0.497 ) . Mean FEV1 was similar in the two groups both before and after the study . Controls had significantly higher scores for cough ( 1.85 + /- 0.43 vs. 1.42 + /- 0.28 , p night symptoms ( 1.22 + /- 0.23 vs. 0.85 + /- 0.32 , p daily consumption of inhaled medicine , forced vital capacity , or compliance . Per patient , per week , the additional cost of follow-up by SMS was Euros 1.67 ( equivalent to approximately $ 1.30 per 1 Euro ) , and SMS transmission required 11.5 minutes . Although a study group of 40 patients is needed for the follow-up study to achieve the power of 80 % within the 95 % confidence interval , we conclude that SMS is a convenient , reliable , affordable , and secure means of telemedicine that may improve asthma control when added to a written action plan and st and ard follow-up",
"Home monitoring of spirometry has been advocated in lung transplant recipients for the early detection of acute infection and rejection of the allograft . We have developed a user-friendly , Internet-based telemonitoring system providing direct transmission of home spirometry to the hospital . In this prospect i ve study , we assessed patient adherence with the monitoring , agreement between home and hospital spirometry , intrasubject coefficient of variation ( CV ) for FEV(1 ) and FEF(25 - 75 ) , and sensitivity of these variables for the detection of acute complications . Twenty-two bilateral-lung and heart-lung transplant recipients were followed for a median of 473 d ( range , 60 - 822 ) , during which 13,833 measurements were obtained . Patient compliance was 55 % for two measurements a day and 84 % for one measurement a day . Agreement between home and hospital spirometry was within 4 % for FEV(1 ) and 6 % for FEF(25 - 75 ) . Mean CV was 3.2 % for FEV(1 ) and 7.5 % for FEF(25 - 75 ) . Using transbronchial lung biopsy and /or bronchoalveolar lavage as gold st and ards , the sensitivity of home spirometry was 63 % , and 23 % of true positives were detected by changes in FEF(25 - 75 ) alone . We conclude that home monitoring of pulmonary function in lung transplant recipients via the Internet is feasible and provides very reproducible data ; yet it has only a mild sensitivity for the detection of acute allograft dysfunction",
"The adherence and disease-control outcomes associated with the use of an Internet-based store- and -forward video home telehealth system to manage asthma in children were studied . Pediatric patients with persistent asthma were provided with home computers and Internet access and monitored biweekly over the Internet . All patients were seen in the pediatric clinic at 0 , 2 , 6 , 12 , and 24 weeks . Half of the patients received asthma education in person and half via an interactive Web site . Adherence measures were assessed by therapeutic and diagnostic monitoring . Therapeutic monitoring included digital videos of patients using their controller medication inhaler . Diagnostic monitoring included an asthma symptom diary and a video of peak flow meter use . Videos were su bmi tted electronically twice a week by using in-home telemonitoring with store- and -forward technology . Feedback was provided electronically to each patient . Disease control was assessed by examining quality of life , utilization of services , rescue-therapy use , symptom control , satisfaction with home telemonitoring , and retention of asthma knowledge . Patients were r and omly assigned to an asthma education group ( Internet versus office ) , and the data were analyzed by comparing results for study days 0 - 90 and 91 - 180 . Ten children participated . A total of 321 videos of inhaler use and 309 videos of peak flow meter use were su bmi tted . Inhaler technique scores improved significantly in the second study period . Su bmi ssion of diagnostic monitoring videos and asthma diary entries decreased significantly . Peak flow values as a percentage of personal best values increased significantly . Overall , there was no change in quality of life reported by patients . However , the caregivers in the virtual-education group reported an increase in the patients ' quality -of-life survey scores . Emergency department visits and hospital admissions for asthma were avoided . Rescue therapy was infrequent . A high rate of satisfaction with home telemonitoring was reported . Internet-based , store- and -forward video assessment of children 's use of asthma medications and monitoring tools in their homes appeared effective and well accepted",
"At the end of a long week in the office , you sink back into your chair , reflecting on some of the more memorable patients you cared for and counseled . Through gentle history taking , you discovered that urinary incontinence is the underlying cause of an elderly patient 's increasing social isolation . During a careful physical examination , you detected bruising on the torso of a woman with chronic headaches and began to explore the longst and ing abusive relationship between the woman and her alcoholic partner . You discontinued procainamide therapy in a 72-year-old man who had asymptomatic premature ventricular contractions after myocardial infa rct ion . To prevent bleeding from esophageal varices , you started -blocker therapy in a woman with long-st and ing cryptogenic cirrhosis and portal hypertension . In couples ' therapy , discussing the future quality of life of a middle-aged gay man with human immunodeficiency virus infection , you journeyed through emotionally intense dialogue about advance directives . You presented the risk factors for major and minor bleeding to a 39-year-old woman who was considering warfarin therapy because of recently diagnosed atrial fibrillation and valvular heart disease . You listened to , made diagnoses for , treated , advised , and comforted many patients . Yet there were some hiccoughs in your practice along the way . You stumbled while debating the pros and cons of breast cancer screening with a healthy 48-year-old woman who has been staying current with information on the Internet . You question ed the merits of a personalized walking program suggested to you by a motivated 66-year-old man with severe claudication . Explaining that you wanted to review the best current evidence on these issues , you resolved to address your uncertainties before these patients made their next office visits , in a week 's time . Sighing deeply , you acknowledge that you have little time to read . You subscribe to three journals , which you browse months after they arrive-either when your journal stack becomes precariously high or when your guilt is sufficiently motivational . You sometimes find the conclusions of individual articles conflicting or confusing . You know that some of the decisions and suggestions you made this week , specifically your decisions about stopping procainamide therapy and starting -blocker therapy and your advice about bleeding risks from anticoagulant therapy , were based on the best current research evidence [ 1 - 3 ] . On the other h and , your patients ' inquiries about breast cancer screening and exercise treatment for claudication highlight your need for a concise , current , rigorous synthesis of the best available evidence on each of these topics : in brief , a systematic review [ 4 , 5 ] . Incorporating Research Evidence into Clinical Decision Making The foregoing scenario is familiar to practitioners . In a typical week , we encounter patients with diverse problems ; exercise numerous clinical , interpersonal , and technical skills ; and make many decisions . The factors that affect these decisions and their outcomes are complex . For instance , each patient has unique sociodemographic characteristics , cultural circumstances , and personal preferences . Each physician has unique knowledge , experiences , and values . Moreover , practitioners and their patients make decisions within the context of a rapidly changing health care system that influences the availability , accessibility , and cost of diagnostic tests and therapies [ 6 ] . Timely , useful evidence from the biomedical literature should be an integral component of clinical decision making . If one treatment has been shown to be better than another , we need to know , so that we can recommend the treatment to the appropriate patients . The worldwide effort to develop new tests and treatments , and to determine their usefulness , has never been stronger , and our patients and their families expect us to be fonts of the knowledge that results from this effort [ 7 ] . Unfortunately , it is easy for current best research evidence to pass us by [ 8 ] . We may lack the time , motivation , and basic skills needed to find , critically appraise , and synthesize information , all of which we must do if we are to integrate the results of original studies into our practice . Fortunately , several potent methods are emerging that can greatly enhance our ability to interpret and apply research evidence ; foremost among them is the systematic review . This article begins a series in Annals that will examine systematic review s in detail and explore their many applications . Systematic review s represent the best chance that most practitioners will have to underst and and accurately apply the key signals arising from the robust and increasingly productive search for solutions to medical problems . A properly conducted systematic review faithfully summarizes the evidence from all relevant studies on the topic of interest , and it does so concisely and transparently . What Is a Systematic Review ? Systematic review s are scientific investigations in themselves , with pre-planned methods and an assembly of original studies as their subjects . They synthesize the results of multiple primary investigations by using strategies that limit bias and r and om error [ 9 , 10 ] . These strategies include a comprehensive search of all potentially relevant articles and the use of explicit , reproducible criteria in the selection of articles for review . Primary research design s and study characteristics are appraised , data are synthesized , and results are interpreted . When the results of primary studies are summarized but not statistically combined , the review may be called a qualitative systematic review . A quantitative systematic review , or meta- analysis , is a systematic review that uses statistical methods to combine the results of two or more studies . The term overview is sometimes used to denote a systematic review , whether quantitative or qualitative . Summaries of research that lack explicit descriptions of systematic methods are often called narrative review s. Review articles are one type of integrative publication ; practice guidelines , economic evaluations , and clinical decision analyses are others . These other types of integrative articles often incorporate the results of systematic review s. For example , practice guidelines are systematic ally developed statements intended to assist practitioners and patients with decisions about appropriate health care for specific clinical circumstances [ 11 ] . Evidence -based practice guidelines are based on systematic review s of the literature , appropriately adapted to local circumstances and values . Economic evaluations compare both the costs and the consequences of different courses of action ; the knowledge of consequences that are considered in these evaluations is often generated by systematic review s of primary studies . Decision analyses quantify both the likelihood and the valuation of the expected outcomes associated with competing alternatives . Differences between Systematic and Narrative Review s All review s , narrative and systematic alike , are retrospective , observational research studies and are therefore subject to systematic and r and om error . Accordingly , the quality of a review - and thus its worth-depends on the extent to which scientific review methods have been used to minimize error and bias . This is the key feature that distinguishes traditional narrative review s from systematic review s ( Table 1 ) . If a review is prepared according to the steps outlined in the right column of Table 1 , it is more likely to be systematic and to provide unbiased conclusions . If review methods approximate those found in the middle column of Table 1 , the article is more likely to be a narrative review , and the conclusions are less likely to be based on an unbiased summary of all relevant evidence . Table 1 . Differences between Narrative Review s and Systematic Review s Systematic review s are generated to answer specific , often narrow , clinical questions in depth . These questions can be formulated explicitly according to four variables : a specific population and setting ( such as elderly out patients ) , the condition of interest ( for example , hypertension ) , an exposure to a test or treatment ( such as pharmacologic management ) , and one or more specific outcomes ( such as cardiovascular and cerebrovascular events and mortality ) [ 12 ] . Thus , an example of a well-formulated , clinical ly relevant question is , Does pharmacologic treatment of hypertension in the elderly prevent strokes and myocardial infa rct ions or delay death ? If the question that is driving the review is not clear from the title , abstract , or introduction , or if no methods section is included , the paper is more likely to be a narrative review than a systematic review [ 13 ] . Most narrative review articles deal with a broad range of issues related to a given topic rather than addressing a particular issue in depth [ 9 ] . For example , a narrative review on diabetes ( such as that which might be found in a textbook chapter ) might include sections on the physiology and pathophysiology of carbohydrate , lipid , and protein metabolism ; the epidemiology of and prognosis associated with diabetes ; diagnostic and screening approaches ; and preventive , therapeutic , rehabilitative , and palliative interventions . Thus , narrative review s may be most useful for obtaining a broad perspective on a topic ; they are less often useful in furnishing quantitative answers to specific clinical questions . Narrative review s are appropriate for describing the history or development of a problem and its management . Narrative review s may better describe cutting-edge developments if research is scant or preliminary or if studies are very limited by flawed design or execution [ 13 ] . They may be particularly useful for discussing data in light of underlying theory and context . Narrative review s can draw analogies and can conceptually integrate two independent fields of research , such as",
"Although the use of telecommunication systems in medicine has been increasing , few trials have assessed the efficacy of such technology for improving blood pressure in patients with essential hypertension ( 1 , 2 ) . Friedman and colleagues ( 1 ) found that when hypertensive patients used a telephone-linked computer system to report blood pressure , diastolic blood pressure decreased significantly . Bondmass and colleagues ( 2 ) also found a significant decrease in both diastolic and systolic blood pressure , although their trial lacked controls . In these studies and in other trials of home monitoring , self-report of blood pressure was the basic mechanism for transmission of information to physicians ( 1 - 8 ) . This may have consequences for patient care , since it has recently been shown that patients often erroneously report blood pressure , especially patients whose blood pressure is uncontrolled ( 9 ) . Johnson and colleagues ( 9 ) found that in approximately 20 % of instances , self-report of blood pressure differed from the electronic reading by more than 10 mm Hg . Another limitation of previous trials is accurate assessment of the outcome . In some studies , the outcome was determined by one or two blood pressure readings taken during an office visit or by a technician in the home setting ( 1 , 4 - 7 ) . Only one study of 31 patients used automatic ambulatory blood pressure monitoring ( ABPM ) to assess usual blood pressure at baseline and exit ( 3 ) . Twenty-fourhour ABPM recordings yield a more reliable assessment of usual blood pressure levels during the course of daily activities ( 10 ) . To improve on the previous studies , we design ed a r and omized , controlled trial that used 24-hour ABPM measurements at baseline and at exit to determine change in blood pressure more accurately . The intervention was a service provided to physicians that used electronic transmission of results and did not rely on self-report of blood pressure . Methods Study Protocol From May 1999 to April 2000 , five internists from the Department of Medicine at the State University of New York Upstate Medical University in Syracuse recruited patients from internal medicine outpatient practice s affiliated with the general medicine division . Out patients seen by these physicians were covered by private insurance plans or Medicare . Eligible patients were adults who had previously received a diagnosis of essential hypertension and were under evaluation for a change in antihypertensive therapy because of 1 ) elevated blood pressure [ systolic pressure 140 or diastolic pressure 90 mm Hg ] despite current antihypertensive therapy , 2 ) undesirable side effects of current antihypertensive medication , or 3 ) office systolic pressure of at least 180 mm Hg or diastolic pressure of at least 110 mm Hg with no current use of antihypertensive medication . For patients with diabetes mellitus , heart disease , stroke , nephropathy , peripheral arterial disease , or hypertensive retinopathy , an office systolic pressure of at least 130 mm Hg or an office diastolic pressure of at least 85 mm Hg was a criterion for eligibility . Patients who were younger than 18 years of age , were pregnant , had secondary hypertension , or did not have the mental or physical capacity to monitor blood pressure at home were excluded . All patients were informed of the study procedures , the risks and benefits of participation , confidentiality , rights , and personnel to contact for additional information . The institutional review board at Upstate Medical University approved the trial , and all patients gave written consent before participation . Patients received printed educational material s on nonpharmacologic approaches to blood pressure control from the National Heart , Lung , and Blood Institute ( 11 ) . These approaches included reducing weight , increasing physical activity , and changing diet if necessary . At baseline , height and weight were recorded at the clinic for all patients . Body mass index was calculated as kg/m2 . Printed information on the treatment of hypertension from the Sixth Report of the Joint National Committee on Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( National High Blood Pressure Education Program ) ( 12 ) was available at each clinical site as a reference for physicians and clinical staff . Study Group Assignment We conducted a r and omized trial with concurrent controls . The two study groups were home service and usual care . To ensure an equal number of patients in both study groups , we used a blocking procedure with r and om permuted blocks of varying size to reduce predictability . R and omization was stratified by the number of prescription medications patients were taking ( 0 to 2 or 3 ) at study entry , which served as a general indicator of morbidity . Sequentially numbered , sealed , opaque envelopes were used for assignment . The r and omization procedure was concealed to physicians and clinical research staff , but physicians , investigators , and patients were aware of group assignment when r and omization was complete . In addition , adherence to the protocol was monitored independently of the clinicians . A priori sample size was calculated to detect a mean ( SD ) difference in blood pressure of 3 5 mm Hg between the two study groups . This yielded 60 patients per group with 90 % power ( = 0.05 [ two-tailed ] ) . Intervention The intervention was a telecommunication service consisting of three components : automatic blood pressure recording at home , central processing , and electronic reports provided weekly to the primary physician and patient . We used a home blood pressure monitoring device that transmitted data over analog telephone lines ( Model 52500 , Welch Allyn , Inc. , Skaneateles Falls , New York ) and was vali date d according to the st and ards of the American National St and ard Institute , Inc. , and the Association for the Advancement of Medical Instrumentation ( 13 ) . The oscillometric device ( 16.26 cm 10.92 cm 6.6 cm ) had a digital display for blood pressure and pulse and used automatic pressurization and exhaust for cuff inflation and deflation . Patients were instructed to take their blood pressure three times in the morning before eating or drinking and three times in the evening before going to bed . After each reading , the device automatically dialed the Service and Support Center at Welch Allyn and transmitted the data . Patients were asked to conduct this routine at least three days each week for a minimum of 8 weeks and could take additional readings if they desired . A computer program was developed to display the results in a report form , which was then faxed to each patient 's physician . The report form contained information on the mean systolic pressure , mean diastolic pressure , and heart rate ( overall , morning , and evening ) . It also graphed the pressure by date and displayed individual readings in tabular form . Both physicians and patients received a report form each week , as well as a summary report form at the end of the trial . When physicians received report forms that indicated elevated pressure , they adjusted antihypertensive medications through a telephone call , an office visit , or both . At the time of the trial , the service cost $ 24.95 per month . Patients assigned to usual care were treated for hypertension according to the guidelines of the Joint National Committee on Prevention , Detection , and Treatment of High Blood Pressure ( 12 ) . Question naire Information Information about patients ' medical histories , past diagnoses of disease , and use of medications was obtained from question naires . The Baecke question naire of habitual physical activity was used to assess usual activity levels ( 14 ) . Subscales included a work index , a sports index , and a nonsports leisure index , as well as a total physical activity score . Dietary intake was estimated by using the Block screening question naire , which consists of two subscales : intake of highly saturated fatty foods and intake of fruit , vegetables , and high-fiber grains ( 15 ) . Questions about smoking and stress were taken from the previously vali date d Health Habits and History Question naire ( 16 ) . The study question naire was collected at the time of the second 24-hour ambulatory readings . Outcome Measures The primary end point was the change in mean arterial pressure during the trial ( baseline to exit ) for home service compared with usual care . A clinical research nurse ( the study manager ) fitted participants with a 24-hour ABPM device at baseline and at exit . The nurse gave the patients detailed instructions for using the device . The ABPM device automatically recorded blood pressure every half-hour from 7:00 a.m. to 11:00 p.m. and every hour from 11:00 p.m. to 7:00 a.m. Information from baseline and exit ABPM readings was given to physicians only after the patient exited the trial . All blood pressure measurements indicated in this report refer to these 24-hour readings . Means and SDs were recorded for systolic pressure , diastolic pressure , arterial pressure , and heart rate by using 24-hour ABPM . Mean arterial pressure was measured as ( diastolic pressure + 1/3 [ systolic pressure diastolic pressure ] ) . The ABPM device also recorded the percentage of readings above the desired target levels ( 140 mm Hg systolic or 90 mm Hg diastolic for patients without target organ damage ; 130 mm Hg systolic or 85 mm Hg diastolic for patients with target organ damage ) . Patients were scheduled to remain in the trial for a minimum of 8 weeks . During the sixth and seventh weeks , appointments were made to schedule second 24-hour ABPM sessions . For both the home service and usual care groups , the median time from baseline to exit was 11 weeks . The final patient receiving usual care exited at 20 weeks , and the final patient receiving home service exited at 28 weeks . Statistical Analysis All information was entered into an Excel data base ( Microsoft Corp. , Redmond , Washington ) and was manually rechecked for errors . Statistical analyses were conducted by using STATISTICA software (",
"OBJECTIVE To determine whether modem technology allows for effective management of type 1 diabetes when used in lieu of a clinic visit . RESEARCH DESIGN AND METHODS A total of 70 adolescent patients with diabetes were prospect ively r and omized to either a control group or a modem group . Control group patients continued the st and ard of care of quarterly clinic visits , and modem group patients were instructed to transmit blood glucose data every 2 weeks for 6 months instead of a usual quarterly clinic visit . Health care providers analyzed the data received by modem and contacted patients to discuss diabetes treatment changes . GHbA(1c ) levels were determined at 0 and 6 months , and the number of high and low blood glucose levels and adverse events were tracked . Clinic visit costs , patient expenses , and health care provider times were tracked for cost analysis for both groups . RESULTS A total of 63 patients ( 33 control , 30 modem ) completed the 6-month study . The GHbA(1c ) values significantly decreased in both groups , with no statistically significant difference between groups ( P = 0.96 ) . The occurrence of mild-to-moderate hypoglycemic events were similar in the two groups , and there were no severe hypoglycemic events . The average cost of care for a clinic visit was $ 305.00 , whereas the cost for 6 months of modem transmission was $ 163.00 . CONCLUSIONS This study shows that electronic transmission of blood glucose levels and other diabetes data every 2 weeks-in lieu of a clinic visit- results in a similar level of glucose control and incidence of acute diabetes complications when compared with current st and ard care",
"This project tested the importance of enhanced information transfer of home monitoring results to health care providers . The study tested whether computer-assisted communication of medical information between the chronic care patient and the physician can result in health care benefit . The information tools were constructed/adapted as a test of this hypothesis for diabetes mellitus . Patients connected a glucometer to an intelligent modem weekly for six to nine months . Graphical and mathematical tools extracted and emphasized the information content of the home monitoring data arriving at the central site . Data smoothing , trend analysis , and calculation of quality control statistics were incorporated into a graphical time series oriented report that was used by the health care provider during an outpatient visit . The integrated home monitoring system was tested on 20 patients with diabetes in a double cross-over design over a 15-month period . A significant improvement in serum glucose control as measured by glycated hemoglobin was shown in the study group , but not in the control group"
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The evidence on the association between baseline vitamin D status and risk of incident hypertension in general population s is limited and has not been reliably quantified . We conducted a systematic review and meta- analysis of published prospect i ve studies evaluating the associations of baseline vitamin D status ( circulating 25-hydroxyvitamin D [ 25(OH)D ] levels and dietary vitamin D intake ) with risk of hypertension . Eligible studies were identified in a literature search of MEDLINE , EMBASE , and Web of Science up to November 2012 . Pooled relative risks ( RRs ) with 95 % confidence intervals were calculated using r and om effects models . Generalized least-squares trend estimation was used to assess dose – response relationships . Of the 2,432 articles review ed for eligibility , eight unique prospect i ve cohorts with aggregate data on 283,537 non-overlapping participants and 55,816 incident hypertension cases were included . The RRs ( 95 % CIs ) for hypertension in a comparison of extreme thirds of baseline levels of vitamin D were 0.70 ( 0.58 , 0.86 ) for seven studies that measured blood 25(OH ) D levels and 1.00 ( 0.95 , 1.05 ) for four studies that assessed dietary vitamin D intake . The pooled RR of incident hypertension per 10 ng/mL increment in baseline 25(OH)D levels was 0.88 ( 0.81 , 0.97 ) in dose – response analysis . Evidence was lacking of heterogeneity among studies that measured blood 25(OH ) D levels and those that assessed dietary vitamin D status . Studies are needed to determine whether the association of vitamin D with hypertension represents a causal association and also to determine whether vitamin D therapy may be beneficial in the prevention or the treatment of hypertension
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"Background Mendelian r and omization ( MR ) studies use genetic variants mimicking the influence of a modifiable exposure to assess and quantify a causal association with an outcome , with an aim to avoid problems with confounding and reverse causality affecting other types of observational studies . Aim We evaluated genetic markers that index differences in 25-hydroxyvitamin D ( 25(OH)D ) as instruments for MR studies on vitamin D. Methods and Findings We used data from up-to 6,877 participants in the 1958 British birth cohort with information on genetic markers and 25(OH)D. As potential instruments , we selected 20 single nucleotide polymorphisms ( SNP ) which are located in the vitamin D metabolism pathway or affect skin pigmentation/tanning , including 4 SNPs from genome-wide association ( GWA ) meta-analyses on 25(OH)D. We analyzed SNP associations with 25(OH)D and evaluated the use of allele scores dividing genes to those affecting 25(OH)D synthesis ( DHCR7 , CYP2R1 ) and metabolism ( GC , CYP24A1 , CYP27B1 ) . In addition to the GWA SNPs , only two SNPs ( CYP27B1 , OCA2 ) showed evidence for association with 25(OH)D , with the OCA2 association abolished after lifestyle adjustment . Per allele differences varied between −0.02 and −0.08 nmol/L ( P≤0.02 for all ) , with a 6.1 nmol/L and a 10.2 nmol/L difference in 25(OH)D between individuals with highest compared lowest number of risk alleles in synthesis and metabolism allele scores , respectively . Individual SNPs but not allele scores showed associations with lifestyle factors . An exception was geographical region which was associated with synthesis score . Illustrative power calculations ( 80 % power , 5 % alpha ) suggest that approximately 80,000 participants are required to establish a causal effect of vitamin D on blood pressure using the synthesis allele score . Conclusions Combining SNPs into allele scores provides a more powerful instrument for MR analysis than a single SNP in isolation . Population stratification and the potential for pleiotropic effects need to be considered in MR studies on vitamin",
"Hydroxylation of 25(OH)D to 1,25-dihydroxyvitamin D and signaling through the vitamin D receptor occur in various tissues not traditionally involved in calcium homeostasis . Laboratory studies indicate that 1,25-dihydroxyvitamin D suppresses renin expression and vascular smooth muscle cell proliferation ; clinical studies demonstrate an inverse association between ultraviolet radiation , a surrogate marker for vitamin D synthesis , and blood pressure . We prospect ively studied the independent association between measured plasma 25-hydroxyvitamin D [ 25(OH)D ] levels and risk of incident hypertension and also the association between predicted plasma 25(OH)D levels and risk of incident hypertension . Two prospect i ve cohort studies including 613 men from the Health Professionals ’ Follow-Up Study and 1198 women from the Nurses ’ Health Study with measured 25(OH)D levels were followed for 4 to 8 years . In addition , 2 prospect i ve cohort studies including 38 388 men and 77 531 women with predicted 25(OH)D levels were followed for 16 to 18 years . During 4 years of follow-up , the multivariable relative risk of incident hypertension among men whose measured plasma 25(OH)D levels were relative risk of 2.67 ( 95 % CI : 1.05 to 6.79 ) . The pooled relative risk combining men and women with measured 25(OH)D levels using the r and om-effects model was 3.18 ( 95 % CI : 1.39 to 7.29 ) . Using predicted 25(OH)D levels in the larger cohorts , the multivariable relative risks comparing the lowest to highest deciles were 2.31 ( 95 % CI : 2.03 to 2.63 ) in men and 1.57 ( 95 % CI : 1.44 to 1.72 ) in women . Plasma 25(OH)D levels are inversely associated with risk of incident hypertension",
"Associations between modifiable exposures and disease seen in observational epidemiology are sometimes confounded and thus misleading , despite our best efforts to improve the design and analysis of studies . Mendelian r and omization-the r and om assortment of genes from parents to offspring that occurs during gamete formation and conception-provides one method for assessing the causal nature of some environmental exposures . The association between a disease and a polymorphism that mimics the biological link between a proposed exposure and disease is not generally susceptible to the reverse causation or confounding that may distort interpretations of conventional observational studies . Several examples where the phenotypic effects of polymorphisms are well documented provide encouraging evidence of the explanatory power of Mendelian r and omization and are described . The limitations of the approach include confounding by polymorphisms in linkage disequilibrium with the polymorphism under study , that polymorphisms may have several phenotypic effects associated with disease , the lack of suitable polymorphisms for study ing modifiable exposures of interest , and canalization-the buffering of the effects of genetic variation during development . Nevertheless , Mendelian r and omization provides new opportunities to test causality and demonstrates how investment in the human genome project may contribute to underst and ing and preventing the adverse effects on human health of modifiable exposures",
"BACKGROUND Vitamin D deficiency may be involved in the development of atherosclerosis and coronary heart disease in humans . METHODS We assessed prospect ively whether plasma 25-hydroxyvitamin D ( 25[OH]D ) concentrations are associated with risk of coronary heart disease . A nested case-control study was conducted in 18,225 men in the Health Professionals Follow-up Study ; the men were aged 40 to 75 years and were free of diagnosed cardiovascular disease at blood collection . The blood sample s were returned between April 1 , 1993 , and November 30 , 1999 ; 99 % were received between April 1 , 1993 , and November 30 , 1995 . During 10 years of follow-up , 454 men developed nonfatal myocardial infa rct ion or fatal coronary heart disease . Using risk set sampling , controls ( n = 900 ) were selected in a 2:1 ratio and matched for age , date of blood collection , and smoking status . RESULTS After adjustment for matched variables , men deficient in 25(OH)D ( risk for MI compared with those considered to be sufficient in 25(OH)D ( > or=30 ng/mL ) ( relative risk [ RR ] , 2.42 ; 95 % confidence interval [ CI ] , 1.53 - 3.84 ; P elevated risk relative to those with sufficient 25(OH)D levels ( 22.6 - 29.9 ng/mL : RR , 1.60 [ 95 % CI , 1.10 - 2.32 ] ; and 15.0 - 22.5 ng/mL : RR , 1.43 [ 95 % CI , 0.96 - 2.13 ] , respectively ) . CONCLUSION Low levels of 25(OH)D are associated with higher risk of myocardial infa rct ion in a grade d manner , even after controlling for factors known to be associated with coronary artery disease",
"Prospect i ve epidemiologic studies generally rely on 1 baseline biologic sample from participants for measurement of prediagnostic biomarkers , assuming that 1 measurement adequately represents the participant 's \" typical \" level . The body of work assessing the reproducibility of circulating serum 25-hydroxyvitamin D ( 25(OH)D ) levels over time focuses almost exclusively on population s of European descent , and data for vitamin D-binding protein ( VDBP ) are virtually nonexistent . Thus , the authors measured levels of serum 25(OH)D and VDBP twice in sample s collected between 2005 and 2008 from 225 participants ( 155 black , 70 white ) in the Southern Community Cohort Study . Reproducibility for 25(OH)D was uniformly high , with adjusted intraclass correlation coefficients ( ICCs ) of 0.84 ( 95 % confidence interval ( CI ) : 0.79 , 0.88 ) for blacks and 0.92 ( 95 % CI : 0.87 , 0.95 ) for whites , and there was substantial agreement for assignment of 25(OH)D quartile ( κ = 0.83 , 95 % CI : 0.78 , 0.87 ) and vitamin D adequacy status ( κ = 0.76 , 95 % CI : 0.69 , 0.83 ) . VDBP levels were highly stable over time , with adjusted ICCs of 0.97 ( 95 % CI : 0.96 , 0.98 ) for blacks and 0.96 ( 95 % CI : 0.93 , 0.97 ) for whites . These findings suggest that single , baseline 25(OH)D and VDBP serum measurements provide reasonably representative measures of these compounds for both white and black adults , demonstrating their utility as epidemiologic biomarkers in prospect i ve studies",
"Emerging evidence suggests an inverse relation between vitamin D and blood pressure . We examined the independent association between intake of vitamin D and the risk of incident hypertension among participants of 3 large and independent prospect i ve cohorts : Nurses Health Study I ( NHS I ; n=77 436 ) , NHS II ( n=93 803 ) , and Health Professionals ’ Follow-up Study ( HPFS ; n=38 074 ) . Relative risks and 95 % confidence intervals for incident hypertension were computed according to quintiles of vitamin D intake using Cox proportional hazards regression and adjusted for relevant covariates . Each cohort was followed for ≥8 years . Vitamin D intake was not associated with the risk of developing hypertension . The multivariable relative risk estimates for the highest compared with lowest quintile of intake were 0.98 ( 0.93 to 1.04 ) in NHS I , 1.13 ( 0.99 to 1.29 ) in NHS II , and 1.03 ( 0.93 to 1.15 ) in HPFS . When we compared participants who consumed ≥1600 to intake of vitamin D is not associated with a lower risk of incident hypertension ",
"Numerous cross-sectional studies demonstrate an inverse association between plasma 25-hydroxyvitamin D [ 25(OH)D ] and blood pressure or hypertension . Prospect i ve data , however , are limited . Among 1484 women aged 32 to 52 years who did not have hypertension at baseline , we prospect ively analyzed the association between plasma levels of 25(OH)D and the odds of incident hypertension using a nested case-control study design . We matched cases and controls on age , race , and month of blood collection and further adjusted for body mass index , physical activity , family history of hypertension , oral contraceptive use , and plasma levels of parathyroid hormone , calcium , phosphorous , creatinine , and uric acid . Median plasma 25(OH)D levels were lower in the cases ( 25.6 ng/mL ) than in the controls ( 27.3 ng/mL ; P incident hypertension of 1.66 ( 95 % CI : 1.11 to 2.48 ; P for trend=0.01 ) . Compared with women with sufficient levels , those with vitamin D deficiency ( Plasma 25(OH)D levels are inversely and independently associated with the risk of developing hypertension",
"Vitamin D receptors have been detected in vascular smooth muscle cells , and 1,25-dihydroxyvitamin D inhibits the renin mRNA expression . Epidemiological studies show an inverse relation between serum 25-hydoxyvitamin D levels and blood pressure , and low serum 25-hydoxyvitamin D levels are reported to be predictors of future development of hypertension . This may indicate an important role for vitamin D in blood pressure regulation . In the present study , 25-hydoxyvitamin D was measured in sera collected in 1994 from 4125 subjects who did not use blood pressure medication , and thereafter measurement was repeated in 2008 for 2385 of these subjects . In sera from 1994 there was a significant decrease in age , body mass index , and systolic blood pressure and a significant increase in physical activity score across increasing 25-hydoxyvitamin D quartiles . After adjusting for sex , age , body mass index , and physical activity , the difference in systolic blood pressure between the lowest and highest serum 25-hydoxyvitamin D quartiles was 3.6 mm Hg . After adjustment for confounders , serum 25-hydoxyvitamin D from 1994 did not predict future hypertension or increase in blood pressure , nor was there any significant association between change in serum 25-hydoxyvitamin D from 1994 to 2008 and change in blood pressure . Our results do not support a causal role for vitamin D in blood pressure regulation , and large r and omized clinical trials , preferably including subjects with hypertension and /or low serum 25-hydoxyvitamin D levels , are greatly needed to clarify whether vitamin D supplementation affects the blood pressure",
"Experimental and epidemiological studies suggest that calcium and vitamin D supplements may lower blood pressure . We examined the effect of calcium plus vitamin D supplementation on blood pressure and the incidence of hypertension in postmenopausal women . The Women 's Health Initiative Calcium/Vitamin D Trial r and omly assigned 36 282 postmenopausal women to receive 1000 mg of elemental calcium plus 400 IU of vitamin D3 daily or placebo in a double-blind fashion . Change in blood pressure and the incidence of hypertension were ascertained . Over a median follow-up time of 7 years , there was no significant difference in the mean change over time in systolic blood pressure ( 0.22 mm Hg ; 95 % CI : −0.05 to 0.49 mm Hg ) and diastolic blood pressure ( 0.11 mm Hg ; 95 % CI : −0.04 to 0.27 mm Hg ) between the active and placebo treatment groups . This None result was robust in analyses accounting for nonadherence to study pills and in baseline subgroups of interest , including black subjects and women with hypertension or high levels of blood pressure , with low intakes of calcium and vitamin D or low serum levels of vitamin D. In 17 122 nonhypertensive participants at baseline , the hazard ratio for incident hypertension associated with calcium/vitamin D treatment was 1.01 ( 95 % CI : 0.96 to 1.06 . ) In postmenopausal women , calcium plus vitamin D3 supplementation did not reduce either blood pressure or the risk of developing hypertension over 7 years of follow-up",
"A major problem in review ing the published results of different epidemiologic studies of the relation between a quantitative variable and the risk of disease is that the results are presented in many different ways . The purpose of this paper is to exemplify methods by which results expressed either as risks ( or rates ) according to quantlle groups of the quantitative variable or as results derived from a logistic regression analysis can be reexpressed in a uniform manner , as a mean difference in the quantitative variable between the cases of disease and the other subjects in the study . An important assumption of the methods is that the quantitative variable has an approximately normal distribution , and a way of investigating the appropriateness of this assumption is given . The methods can be applied to both prospect i ve and case-control studies and are exemplified by a number of studies of serum albumin concentrations and mortality . In some applications , these methods can be used as a precursor to formal meta- analysis , for example , when differential control of potential confounding factors is not a problem . At the least , the methods can be useful either in quantitatively review ing published studies before undertaking new research or in putting the results of a new study into the context of previously published ones",
"In r and omized trials , the effect of vitamin D supplementation on blood pressure has been equivocal , while most prospect i ve cohort studies have shown that the risk of incident hypertension is lower in people with higher levels of 25-hydroxyvitamin D ( 25(OH)D ) . The authors examined the association between levels of 25(OH)D and changes in blood pressure and incident hypertension in 4,863 postmenopausal women recruited into the Women 's Health Initiative between 1993 and 1998 . Over 7 years , there were no significant differences in the adjusted mean change in systolic or diastolic blood pressure by quartile of 25(OH)D. The covariate-adjusted risk of incident hypertension was slightly lower in the upper 3 quartiles of 25(OH)D compared with the lowest quartile , but this was statistically significant only in the third quartile ( hazard ratio = 0.67 , 95 % confidence interval : 0.46 , 0.96 ) . There was no significant linear or nonlinear trend in the risk of incident hypertension by untransformed or log-transformed continuous values of 25(OH)D. In postmenopausal women in this study , serum levels of 25(OH)D were not related to changes in blood pressure , and evidence for an association with lower risk of incident hypertension was weak",
"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 Short trials of calcium supplementation show that it reduces loss of bone density in postmenopausal women ; longer observational studies do not generally find a lower risk of hip fracture with higher-calcium diets . Fewer studies have focused on vitamin D in preventing postmenopausal osteoporosis or fractures . OBJECTIVE We assessed relations between postmenopausal hip fracture risk and calcium , vitamin D , and milk consumption . DESIGN In an 18-y prospect i ve analysis in 72 337 postmenopausal women , dietary intake and nutritional supplement use were assessed at baseline in 1980 and up date d several times during follow-up . We identified 603 incident hip fractures result ing from low or moderate trauma . Relative risks ( RRs ) from proportional hazards models were controlled for other dietary and nondietary factors . RESULTS Women consuming > or = 12.5 microg vitamin D/d from food plus supplements had a 37 % lower risk of hip fracture ( RR = 0.63 ; 95 % CI : 0.42 , 0.94 ) than did women consuming Total calcium intake was not associated with hip fracture risk ( RR = 0.96 ; 95 % CI : 0.68 , 1.34 for > or = 1200 compared with lower risk of hip fracture ( P for trend = 0.21 ) . CONCLUSIONS An adequate vitamin D intake is associated with a lower risk of osteoporotic hip fractures in postmenopausal women . Neither milk nor a high-calcium diet appears to reduce risk . Because women commonly consume less than the recommended intake of vitamin D , supplement use or dark fish consumption may be prudent",
"BACKGROUND Elevated circulating concentrations of proinflammatory cytokines may contribute to the pathogenesis of congestive heart failure ( CHF ) . In vitro studies suggest that vitamin D suppresses proinflammatory cytokines and increases antiinflammatory cytokines . OBJECTIVE We evaluated the effect of vitamin D supplementation on the survival rate and different biochemical variables in patients with CHF . DESIGN One hundred twenty-three patients r and omly received either 50 mug vitamin D(3)/d plus 500 mg Ca/d [ D(+ ) group ] or placebo plus 500 mg Ca/d [ D(- ) group ] for 9 mo . Biochemical variables were assessed at baseline and after 9 mo . The survival rate was calculated for a follow-up period of 15 mo . RESULTS Ninety-three patients completed the study . Significant treatment effects were observed on logarithmic-transformed serum concentrations of 25-hydroxyvitamin D ( P = 0.001 ) , parathyroid hormone ( P = 0.007 ) , tumor necrosis factor alpha ( P = 0.006 ) , and interleukin 10 ( P = 0.042 ) . 25-Hydroxyvitamin D increased by 26.8 ng/mL in the D(+ ) group but increased only by 3.6 ng/mL in the D(- ) group . Compared with baseline , parathyroid hormone was significantly lower and the antiinflammatory cytokine interleukin 10 was significantly higher in the D(+ ) group after 9 mo . The proinflammatory cytokine tumor necrosis factor alpha increased in the D(- ) group but remained constant in the D(+ ) group . The survival rate did not differ significantly between the study groups during the follow-up period . CONCLUSIONS Vitamin D(3 ) reduces the inflammatory milieu in CHF patients and might serve as a new antiinflammatory agent for the future treatment of the disease . Our data provide evidence for the involvement of an impaired vitamin D-parathyroid hormone axis in the progression of CHF",
"BACKGROUND Low 25-hydroxy-vitamin D ( 25(OH)D ) levels are inversely related to blood pressure ( BP ) and have been associated with incident hypertension . In people living at northern latitudes diminished cholecalciferol synthesis in the winter increases the risk of vitamin D deficiency . We wanted to test the hypothesis that daily cholecalciferol supplementation in the winter lowers BP in patients with hypertension . METHODS We investigated the effect of 75 µg ( 3,000 IU ) cholecalciferol per day in a r and omized , placebo-controlled , double-blind study in 130 hypertensive patients residing in Denmark ( 56º N ) . Ambulatory BP ( 24-h BP ) and arterial stiffness were measured before and after 20 weeks of treatment , that took place between October and March . RESULTS A total of 112 patients ( mean age 61 ± 10 ) with a baseline p-25(OH)D of 23 ± 10 ng/ml completed the study . Compared with placebo , a nonsignificant 3/1 mm Hg ( P = 0.26/0.18 ) reduction was found in 24-h BP . In patients with vitamin D insufficiency ( 92 ) , 24-h BP decreased by 4/3 mm Hg ( P = 0.05/0.01 ) . Central BP ( CBP ) estimated by applanation tonometry and calibrated with a st and ardized office BP was reduced by 7/2 mm Hg ( P = 0.007/0.15 ) vs. placebo . No differences in carotid-femoral pulse wave velocity ( PWV ) or central augmentation index ( AIx ) were found between treatment arms . CONCLUSIONS Cholecalciferol supplementation , by a dose that effectively increased vitamin D levels , did not reduce 24-h BP , although central systolic BP decreased significantly . In a post-hoc subgroup analysis of 92 subjects with baseline p-25(OH)D levels decreases in 24-h systolic and diastolic BP occurred during cholecalciferol supplementation ",
"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",
"There is epidemiologic evidence of a relationship between calcium deficiency and hypertension . The present study evaluated the effects of alphacalcidol , a synthetic analogue of active vitamin D , given to 29 patients with marginal , intermittent hypercalcaemia . Before therapy there was an inverse relationship between serum calcium levels and diastolic blood pressure ( p less than 0.02 ) . Treatment with 1 microgram alphacalcidol raised the serum calcium by 0.07 mmol/l during a 6-month , double-blind , placebo-controlled trial and caused a significant reduction of diastolic blood pressure by 9.2 mmHg compared with placebo ( p less than 0.01 ) . The study extends previous observations , in normocalcaemic subjects , of inverse relationships between serum calcium and blood pressure indicating a primary disturbance of calcium homeostasis in hypertension . The observation that a physiologic amount of active vitamin D has hypotensive effects agrees with such a concept and suggests a new principle for the treatment of hypertension",
"The effect of cholecalciferol and estrogen-norethindrone treatment on total cholesterol level , high-density lipoprotein cholesterol level , blood pressure , and body mass index was investigated in 74 postmenopausal women in a double-blind , r and omized trial . Blood pressure and body mass index did not change throughout the study . We demonstrated a decrease ( 11 % ) in serum cholesterol level after 1 year of treatment with estrogen-norethindrone . When this treatment was combined with cholecalciferol , a similar decrease ( 13 % ) was observed . The hypocholesterolemic effect was correlated to body mass index in a way that indicated the most pronounced decrease in lean women . The high-density lipoprotein cholesterol/total cholesterol fraction increased by 45 % after 1 year of estrogen-norethindrone treatment , while an increase of 25 % after 1 year was seen when cholecalciferol was added to the treatment . The latter increase was not different from a similar increase in the placebo group . The possible dyslipidemic effect of cholecalciferol , along with the risk of hypercalcemia , emphasizes the caution necessary in cholecalciferol treatment",
"Background Endothelial dysfunction has been proposed as the underlying cause of diabetic angiopathy that eventually leads to cardiovascular disease , the major cause of death in diabetes . We recently demonstrated the ameliorating effect of regular vitamin D intake on the glycemic status of patients with type 2 diabetes ( T2D ) . In this study , the effects of improvement of vitamin D status on glycemic status , lipid profile and endothelial biomarkers in T2D subjects were investigated . Methods Subjects with T2D were r and omly allocated to one of the two groups to receive either plain yogurt drink ( PYD ; containing 170 mg calcium and no vitamin D/250 mL , n1 = 50 ) or vitamin D3-fortified yogurt drink ( FYD ; containing 170 mg calcium and 500 IU/250 mL , n2 = 50 ) twice a day for 12 weeks . Anthropometric measures , glycemic status , lipid profile , body fat mass ( FM ) and endothelial biomarkers including serum endothelin-1 , E-selectin and matrix metalloproteinase (MMP)-9 were evaluated at the beginning and after the 12-week intervention period . Results The intervention result ed in a significant improvement in fasting glucose , the Quantitative Insulin Check Index ( QUICKI ) , glycated hemoglobin ( HbA1c ) , triacylglycerols , high-density lipoprotein cholesterol ( HDL-C ) , endothelin-1 , E-selectin and MMP-9 in FYD compared to PYD ( P of endothelin-1 , E-selectin and MMP-9 concentrations in FYD compared to PYD ( -0.35 ± 0.63 versus -0.03 ± 0.55 , P = 0.028 ; -3.8 ± 7.3 versus 0.95 ± 8.3 , P = 0.003 and -2.3 ± 3.7 versus 0.44 ± 7.1 ng/mL , respectively , P significant for endothelin-1 and MMP-9 ( P = 0.009 and P = 0.005 , respectively ) but disappeared for E-selectin ( P = 0.092 ) . On the contrary , after controlling for serum 25(OH)D , the differences disappeared for endothelin-1(P = 0.066 ) and MMP-9 ( P = 0.277 ) but still remained significant for E-selectin ( P = 0.011 ) . Conclusions Ameliorated vitamin D status was accompanied by improved glycemic status , lipid profile and endothelial biomarkers in T2D subjects . Our findings suggest both direct and indirect ameliorating effects of vitamin D on the endothelial biomarkers . Trial registration Clinical Trials.gov :",
"Disturbances of calcium or vitamin D metabolism have been suggested to be of pathogenetic importance both for hypertension and impaired glucose tolerance , two disorders that are commonly associated . In the present study 65 men , aged 61 - 65 years , with impaired glucose tolerance were enrolled in a prospect i ve , double-blind , placebo-controlled study over 12 weeks evaluating the effects of 0.75 microgram alphacalcidol , a synthetic analog to the active metabolite of vitamin D. In the 26 patients with blood pressure greater than or equal to 150/90 mmHg before treatment a significant reduction ( p less than 0.01 ) of both the systolic ( SBP ) and diastolic ( DBP ) blood pressure was found after therapy ( from 171/95 to 150/88 mmHg ) . The effect was additive to concomitant antihypertensive treatment and was correlated ( p = 0.03 ) to a reduction of serum levels of parathyroid hormone . Also in the whole group of patients given alphacalcidol blood pressure was moderately lowered from a mean of 152/87 + /- 22/10 ( SD ) to 143/84 + /- 17/8 mmHg . There were no relationships between the changes in body weight , blood glucose or insulin parameters and the changes in blood pressure during the trial . The findings are compatible with the concept that calcium metabolism influences blood pressure regulation and suggest that supplementation with a physiologic dose of active vitamin D could be beneficial for patients with high blood pressure",
"Vitamin D has been reported to lower blood pressure in vivo by regulating the renin-angiotensin system ; however , there are limited clinical studies to support this finding in humans . We investigated the effect of vitamin D treatment on hypertension in a three-arm r and omized placebo controlled pilot and feasibility study . We tested placebo with two forms of vitamin D : cholecalciferol ( vitamin D(3 ) ) and the active form of vitamin D , calcitriol . Subjects were recruited from the Atlanta Veterans Affairs Medical Center in Decatur , GA between April and August 2008 . Subjects received 200,000IU of vitamin D(3 ) ( n=3 ) weekly for 3 weeks or matching placebo ( n=3 ) weekly for 3 weeks ( n=3 ) or 0.5mug calcitriol ( n=2 ) taken twice daily for one week . Our primary endpoint was blood pressure measured by 24h ambulatory blood pressure monitor . Subjects receiving calcitriol experienced a 9 % decrease in mean systolic blood pressure ( SBP ) compared placebo ( p calcitriol therapy SBP returned to pre-treatment levels . There was no reduction in blood pressure in the placebo or vitamin D(3 ) groups . Results from this pilot study suggests that active vitamin D therapy may be an effective short-term intervention for reducing blood pressure and needs to be explored further in larger controlled studies",
"Molecular epidemiologic studies of vitamin D and risk of cancer and other health outcomes usually involve a single measurement of the biomarker 25-hydroxyvitamin D [ 25(OH)D ] in serum or plasma . However , the extent to which 25(OH)D concentration at a single time point is representative of an individual 's long-term vitamin D status is unclear . To address this question , we evaluated within-person variability in 25(OH)D concentrations across serum sample s collected at three time points over a 5-year period among 29 participants in the Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial . Blood collection took place year-round , although sample s for a given participant were collected in the same month each year . The within-person coefficient of variation and intraclass correlation coefficient were calculated using variance components estimated from r and om effects models . Spearman rank correlation coefficients were calculated to evaluate agreement between measurements at different collection times ( baseline , + 1 year , + 5 years ) . The within-subject coefficient of variation was 14.9 % [ 95 % confidence interval ( CI ) , 12.4 - 18.1 % ] and the intraclass correlation coefficient was 0.71 ( 95 % CI , 0.63 - 0.88 ) . Spearman rank correlation coefficients comparing baseline to + 1 year , + 1 year to + 5 years , and baseline to + 5 years were 0.65 ( 95 % CI , 0.37 - 0.82 ) , 0.61 ( 0.29 - 0.81 ) , and 0.53 ( 0.17 - 0.77 ) , respectively . Slightly stronger correlations were observed after restricting to non-Hispanic Caucasian subjects . These findings suggest that serum 25(OH)D concentration at a single time point may be a useful biomarker of long-term vitamin D status in population -based studies of various diseases . Cancer Epidemiol Biomarkers Prev ; 19(4 ) ; 927–31 . © 2010 AACR",
"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",
"BACKGROUND Results of several epidemiologic and clinical studies have suggested that there is an excess risk of hypertension and diabetes mellitus in persons with suboptimal intake of vitamin D. METHODS We examined the association between serum levels of 25-hydroxyvitamin D ( 25[OH]D ) and select cardiovascular disease risk factors in US adults . A secondary analysis was performed with data from the Third National Health and Nutrition Examination Survey , a national probability survey conducted by the National Center for Health Statistics between January 1 , 1988 , and December 31 , 1994 , with oversampling of persons 60 years and older , non-Hispanic black individuals , and Mexican American individuals . RESULTS There were 7186 male and 7902 female adults 20 years and older with available data in the Third National Health and Nutrition Examination Survey . The mean 25(OH)D level in the overall sample was 30 ng/mL ( 75 nmol/L ) . The 25(OH)D levels were lower in women , elderly persons ( > or=60 years ) , racial/ethnic minorities , and participants with obesity , hypertension , and diabetes mellitus . The adjusted prevalence of hypertension ( odds ratio [ OR ] , 1.30 ) , diabetes mellitus ( OR , 1.98 ) , obesity ( OR , 2.29 ) , and high serum triglyceride levels ( OR , 1.47 ) was significantly higher in the first than in the fourth quartile of serum 25(OH)D levels ( P Serum 25(OH)D levels are associated with important cardiovascular disease risk factors in US adults . Prospect i ve studies to assess a direct benefit of cholecalciferol ( vitamin D ) supplementation on cardiovascular disease risk factors are warranted",
"Background / Objectives : Some epidemiological and clinical studies have shown that increased dairy consumption or calcium and /or vitamin D supplementation can have a beneficial effect on blood pressure , and lipid and lipoprotein concentrations . The aim of this study was to assess the long-term effects of calcium-vitamin D3 fortified milk on blood pressure and lipid-lipoprotein concentrations in community-dwelling older men . Subjects/ Methods : This is a sub study of a 2-year r and omized controlled trial in which 167 men aged > 50 years were assigned to receive either 400 ml per day of reduced fat ( ∼1 % ) milk fortified with approximately 1000 mg of calcium and 800 IU of vitamin D3 or to a control group receiving no additional fortified milk . Weight , blood pressure , lipid and lipoprotein concentrations were measured every 6 months . Participants on lipid-lowering ( n=32 ) or antihypertensive medication ( n=39 ) were included , but those who commenced , increased or decreased their medication throughout the intervention were excluded ( n=27 ) . Results : In the 140 men included in this study ( milk , n=73 ; control , n=67 ) , there were no significant effects of the calcium-vitamin D3 fortified milk on weight , systolic or diastolic blood pressure , total cholesterol , high-density lipoprotein or low-density lipoprotein cholesterol or triglyceride concentrations at any time throughout the intervention . Similar results were observed after excluding men taking antihypertensive or lipid-lowering medication or limiting the analysis to those with baseline calcium intakes reduced-fat calcium-vitamin D3 fortified milk did not have a beneficial ( nor detrimental ) effect on blood pressure , lipid or lipoprotein concentrations in healthy community-dwelling older men",
"BACKGROUND Vitamin D has shown efficacy in the reduction of proteinuria in patients with chronic kidney disease . This study aim ed to determine the effect of calcitriol on urinary protein excretion in patients with immunoglobulin A ( IgA ) nephropathy . STUDY DESIGN Open-label , non-placebo-controlled , r and omized study . SETTING & PARTICIPANTS 50 patients with IgA nephropathy were enrolled . The main criterion for inclusion was urinary protein excretion > 0.8 g/d after renin-angiotensin system-inhibitor treatment for at least 3 months . INTERVENTION Patients were r and omly assigned ( 1:1 ) to receive 2 doses ( 0.5 μg ) of calcitriol per week or no treatment for 48 weeks . OUTCOMES The primary end point was to compare change in 24-hour urinary protein excretion from baseline to last measurement during treatment . MEASUREMENTS Every 8 weeks , there was measurement of 24-hour urinary protein excretion , serum calcium , serum phosphorus , serum creatinine , and intact parathyroid hormone . RESULTS Measurement of the primary end point showed changes in urinary protein excretion of + 21 % ( from 1.29 to 1.58 g/24 h ; 95 % CI , -9 % to + 52 % ) in the control group and -19 % ( from 1.60 to 1.30 g/24 h ; 95 % CI , -42 % to + 4 % ) in the calcitriol-treated group . There was a significant decrease in proteinuria in the calcitriol-treated group compared with the control group ( difference between groups , 41 % ; 95 % CI , 5%-79 % ; P = 0.03 ) . The secondary end point of achieving at least a 15 % decrease in proteinuria was attained by 7 of 24 ( 29 % ) controls and 17 of 26 ( 65 % ) of those treated with calcitriol ( P = 0.02 ) . No significant differences were observed in decrease in estimated glomerular filtration rate and change in blood pressure between the 2 groups . The incidence of recorded adverse events was similar between the 2 groups . LIMITATIONS Small and non-placebo-controlled study . CONCLUSIONS The addition of calcitriol to a renin-angiotensin system inhibitor result ed in a safe decrease in proteinuria in patients with IgA nephropathy",
"Patients with essential hypertension , in particular those with low plasma renin activity ( PRA ) , are reported to have lowered plasma-ionized calcium and elevated parathyroid hormone levels . In this study 1 microgram alphacalcidol ( 1 alpha-hydroxy-vitamin D3 ) was given in a double-blind , placebo-controlled fashion over four months to 39 subjects with mild to moderate hypertension . There was a significant rise in PRA in the treatment group when compared to placebo ( P less than .05 ) , but the mean blood pressure response was similar in the two groups . When the treatment group was divided according to pretreatment PRA it was , however , seen that subjects with low PRA displayed a reduction in diastolic blood pressure , whereas those with high PRA raised their blood pressure compared to placebo . Also subjects with low pretreatment values for plasma-ionized calcium and high levels of parathyroid hormone showed a reduction in diastolic blood pressure . This study supports the idea of a relationship between calcium metabolism and the renin-aldosterone system in essential hypertension and describes a beneficial effect of vitamin D supplementation on blood pressure in low-renin hypertension",
"Calcium supplementation is effective in reducing blood pressure in various states of hypertension , including pregnancy-induced hypertension and preeclampsia . In addition , calcitropic hormones are associated with blood pressure . The hypothesis is that short-term therapy with calcium and vitamin D(3 ) may improve blood pressure as well as secondary hyperparathyroidism more effectively than calcium monotherapy . The effects of 8 weeks of supplementation with vitamin D(3 ) ( cholecalciferol ) and calcium on blood pressure and biochemical measures of bone metabolism were studied . The sample consisted of 148 women ( mean + /- SD age , 74 + /- 1 yr ) with a 25-hydroxycholecalciferol ( 25OHD(3 ) ) level below 50 nmol/L. They received either 1200 mg calcium plus 800 IU vitamin D(3 ) or 1200 mg calcium/day . We measured intact PTH , 25OHD(3 ) , 1,25-dihydroxyvitamin D(3 ) , blood pressure , and heart rate before and after treatment . Compared with calcium , supplementation with vitamin D(3 ) and calcium result ed in an increase in serum 25OHD(3 ) of 72 % ( P serum PTH of 17 % ( P = 0.04 ) , a decrease in systolic blood pressure ( SBP ) of 9.3 % ( P = 0.02 ) , and a decrease in heart rate of 5.4 % ( P = 0.02 ) . Sixty subjects ( 81 % ) in the vitamin D(3 ) and calcium group compared with 35 ( 47 % ) subjects in the calcium group showed a decrease in SBP of 5 mm Hg or more ( P = 0.04 ) . No statistically significant difference was observed in the diastolic blood pressures of the calcium-treated and calcium- plus vitamin D(3)-treated groups ( P = 0.10 ) . Pearson coefficients of correlation between the change in PTH and the change in SBP were 0.49 ( P vitamin D(3 ) plus calcium group and 0.23 ( P calcium group . A short-term supplementation with vitamin D(3 ) and calcium is more effective in reducing SBP than calcium alone . Inadequate vitamin D(3 ) and calcium intake could play a contributory role in the pathogenesis and progression of hypertension and cardiovascular disease in elderly women",
"CONTEXT Vitamin D is associated with decreased cardiovascular-related morbidity and mortality , possibly by modifying cardiac structure and function , yet firm evidence for either remains lacking . OBJECTIVE To determine the effects of an active vitamin D compound , paricalcitol , on left ventricular mass over 48 weeks in patients with an estimated glomerular filtration rate of 15 to 60 mL/min/1.73 m(2 ) . DESIGN , SETTING , AND PARTICIPANTS Multinational , double-blind , r and omized placebo-controlled trial among 227 patients with chronic kidney disease , mild to moderate left ventricular hypertrophy , and preserved left ventricular ejection fraction , conducted in 11 countries from July 2008 through September 2010 . INTERVENTION Participants were r and omly assigned to receive oral paricalcitol , 2 μg/d ( n = 115 ) , or matching placebo ( n = 112 ) . MAIN OUTCOME MEASURES Change in left ventricular mass index over 48 weeks by cardiovascular magnetic resonance imaging . Secondary end points included echocardiographic changes in left ventricular diastolic function . RESULTS Treatment with paricalcitol reduced parathyroid hormone levels within 4 weeks and maintained levels within the normal range throughout the study duration . At 48 weeks , the change in left ventricular mass index did not differ between treatment groups ( paricalcitol group , 0.34 g/m(2.7 ) [ 95 % CI , -0.14 to 0.83 g/m(2.7 ) ] vs placebo group , -0.07 g/m(2.7 ) [ 95 % CI , -0.55 to 0.42 g/m(2.7 ) ] ) . Doppler measures of diastolic function including peak early diastolic lateral mitral annular tissue velocity ( paricalcitol group , -0.01 cm/s [ 95 % CI , -0.63 to 0.60 cm/s ] vs placebo group , -0.30 cm/s [ 95 % CI , -0.93 to 0.34 cm/s ] ) also did not differ . Episodes of hypercalcemia were more frequent in the paricalcitol group compared with the placebo group . CONCLUSION Forty-eight week therapy with paricalcitol did not alter left ventricular mass index or improve certain measures of diastolic dysfunction in patients with chronic kidney disease . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00497146",
"BACKGROUND We examined data from a cohort of Caucasian women for evidence of an association between serum vitamin D ( 25-hydroxyvitamin D ( 25(OH)D ) ) insufficiency and greater risk of systolic hypertension in the population -based longitudinal Michigan Bone Health and Metabolism Study ( MBHMS ) . METHODS The cohort includes 559 women aged 24 - 44 years in 1992 ; annual blood pressure ( BP ) measurements and data collection began in 1992 and is ongoing . A single-time serum 25(OH)D level was measured in 1993 . Using logistic regression , vitamin D insufficiency ( to systolic hypertension ( ≥140 mm Hg ) measures identified in 1993 and in 2007 . Further , the relationship between vitamin D at baseline and the trajectory of systolic BP across the ensuing 14 years was assessed using longitudinal mixed modeling . RESULTS Vitamin D insufficiency was not significantly associated with concurrent systolic hypertension in 1993 ( odds ratio ( OR ) 1.3 ; 95 % confidence interval ( CI ) ( 0.32 , 5.1 ) ) . However , vitamin D insufficiency was associated with increased risk of systolic hypertension in 2007 ( OR 3.0 ; 95 % CI ( 1.01 , 8.7 ) ) after adjusting for age , body fat percentage , antihypertensive medication use , and smoking . Baseline vitamin D status was not associated with rate of BP change over the 14-year period . CONCLUSIONS Consistent with previous animal and human studies , we found a single-time measure of vitamin D among young adult women was associated with systolic hypertension 14 years later . These prospect i ve results suggest the need for further study of the role vitamin D insufficiency in early adulthood as a risk factor in subsequent hypertension among women",
"BACKGROUND In cross-sectional studies , low serum levels of 25-hydroxyvitamin D are associated with higher prevalence of cardiovascular risk factors and disease . This study aim ed to determine whether endogenous 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D levels are related to all-cause and cardiovascular mortality . METHODS Prospect i ve cohort study of 3258 consecutive male and female patients ( mean [ SD ] age , 62 [ 10 ] years ) scheduled for coronary angiography at a single tertiary center . We formed quartiles according to 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D levels within each month of blood drawings . The main outcome measures were all-cause and cardiovascular deaths . RESULTS During a median follow-up period of 7.7 years , 737 patients ( 22.6 % ) died , including 463 deaths from cardiovascular causes . Multivariate-adjusted hazard ratios ( HRs ) for patients in the lower two 25-hydroxyvitamin D quartiles ( median , 7.6 and 13.3 ng/mL [ to convert 25-hydroxyvitamin D levels to nanomoles per liter , multiply by 2.496 ] ) were higher for all-cause mortality ( HR , 2.08 ; 95 % confidence interval [ CI ] , 1.60 - 2.70 ; and HR , 1.53 ; 95 % CI , 1.17 - 2.01 ; respectively ) and for cardiovascular mortality ( HR , 2.22 ; 95 % CI , 1.57 - 3.13 ; and HR , 1.82 ; 95 % CI , 1.29 - 2.58 ; respectively ) compared with patients in the highest 25-hydroxyvitamin D quartile ( median , 28.4 ng/mL ) . Similar results were obtained for patients in the lowest 1,25-dihydroxyvitamin D quartile . These effects were independent of coronary artery disease , physical activity level , Charlson Comorbidity Index , variables of mineral metabolism , and New York Heart Association functional class . Low 25-hydroxyvitamin D levels were significantly correlated with variables of inflammation ( C-reactive protein and interleukin 6 levels ) , oxidative burden ( serum phospholipid and glutathione levels ) , and cell adhesion ( vascular cell adhesion molecule 1 and intercellular adhesion molecule 1 levels ) . CONCLUSIONS Low 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D levels are independently associated with all-cause and cardiovascular mortality . A causal relationship has yet to be proved by intervention trials using vitamin",
"Patients with primary hyperparathyroidism ( HPT ) often have raised blood pressure but a simple cause- and -effect relationship has not been established . In 33 persons with probable primary HPT and mild hypercalcemia detected in a health survey , diastolic blood pressure ( DBP ) was significantly higher than among age- and sex-matched , normocalcemic , controls ( 89.4 + /- 9.8 ( SD ) v 85.2 + /- 8.9 mm Hg ; P less than 0.05 ) . Among the hypercalcemic individuals , DBP was , in a multivariate analysis , inversely related to the serum calcium and plasma-ionized calcium concentrations and to the serum levels of parathyroid hormone . A prospect i ve , placebo-controlled , double-blind , study evaluating the effects of active vitamin D , alphacalcidol , ( 1 microgram daily ) was carried out in the hypercalcemic patients over a six-month period . This treatment caused a slight further increase ( 0.05 mmol/L ) of both serum calcium and plasma-ionized calcium concentrations . At the same time there was a significant reduction of DBP with a mean of 6.7 mm Hg compared with placebo ( P less than 0.05 ) . The hypotensive action of the vitamin D compound was inversely related to the pretreatment serum levels of 1,25(OH)2D3 and additive to concomitant , unchanged , antihypertensive medications . The negative correlation between serum calcium and blood pressure is similar to that obtained in normocalcemic individuals and suggests that raised blood pressure , at least in the milder forms of primary HPT , is only independently associated with the disease . Active vitamin D , although it raises serum calcium , can lower blood pressure also in hypercalcemic patients as previously demonstrated in normocalcemic individuals",
"Data from laboratory studies , observational research , and /or secondary prevention trials suggest that vitamin D and marine omega-3 fatty acids may reduce risk for cancer or cardiovascular disease ( CVD ) , but primary prevention trials with adequate dosing in general population s ( i.e. , unselected for disease risk ) are lacking . The ongoing VITamin D and OmegA-3 TriaL ( VITAL ) is a large r and omized , double-blind , placebo-controlled , 2 x 2 factorial trial of vitamin D ( in the form of vitamin D(3 ) [ cholecalciferol ] , 2000 IU/day ) and marine omega-3 fatty acid ( Omacor fish oil , eicosapentaenoic acid [EPA]+docosahexaenoic acid [ DHA ] , 1g/day ) supplements in the primary prevention of cancer and CVD among a multi-ethnic population of 20,000 U.S. men aged ≥ 50 and women aged ≥ 55 . The mean treatment period will be 5 years . Baseline blood sample s will be collected in at least 16,000 participants , with follow-up blood collection in about 6000 participants . Yearly follow-up question naires will assess treatment compliance ( plasma biomarker measures will also assess compliance in a r and om sample of participants ) , use of non- study drugs or supplements , occurrence of endpoints , and cancer and vascular risk factors . Self-reported endpoints will be confirmed by medical record review by physicians blinded to treatment assignment , and deaths will be ascertained through national registries and other sources . Ancillary studies will investigate whether these agents affect risk for diabetes and glucose intolerance ; hypertension ; cognitive decline ; depression ; osteoporosis and fracture ; physical disability and falls ; asthma and other respiratory diseases ; infections ; and rheumatoid arthritis , systemic lupus erythematosus , thyroid diseases , and other autoimmune disorders",
"BACKGROUND Despite treatment with renin – angiotensin – aldosterone system ( RAAS ) inhibitors , patients with diabetes have increased risk of progressive renal failure that correlates with albuminuria . We aim ed to assess whether paricalcitol could be used to reduce albuminuria in patients with diabetic nephropathy . METHODS In this multinational , placebo-controlled , double-blind trial , we enrolled patients with type 2 diabetes and albuminuria who were receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers . Patients were assigned ( 1:1:1 ) by computer-generated r and omisation sequence to receive 24 weeks ’ treatment with placebo,1 μg/day paricalcitol , or 2 μg/day paricalcitol . The primary endpoint was the percentage change in geometric mean urinary albumin-to-creatinine ratio ( UACR ) from baseline to last measurement during treatment for the combined paricalcitol groups versus the placebo group . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00421733 . FINDINGS Between February , 2007 , and October , 2008 , 281 patients were enrolled and assigned to receive placebo(n=93 ) , 1 μg paricalcitol ( n=93 ) , or 2 μg paricalcitol ( n=95 ) ; 88 patients on placebo , 92 on 1 μg paricalcitol , and 92 on2 μg paricalcitol received at least one dose of study drug , and had UACR data at baseline and at least one timepoint during treatment , and so were included in the primary analysis . Change in UACR was : –3 % ( from 61 to 60 mg/mmol;95 % CI –16 to 13 ) in the placebo group ; –16 % ( from 62 to 51 mg/mmol ; –24 to –9 ) in the combined paricalcitol groups , with a between-group difference versus placebo of –15 % ( 95 % CI –28 to 1 ; p=0.071 ) ; –14 % ( from 63 to 54 mg/mmol ; –24 to –1 ) in the 1 μg paricalcitol group , with a between-group difference versus placebo of –11%(95 % CI –27 to 8 ; p=0.23 ) ; and –20 % ( from 61 to 49 mg/mmol ; –30 to –8 ) in the 2 μg paricalcitol group , with a between-group difference versus placebo of –18 % ( 95 % CI –32 to 0 ; p=0.053 ) . Patients on 2 μg paricalcitol showed a nearly , sustained reduction in UACR , ranging from –18 % to –28 % ( p=0.014 vs placebo ) . Incidence of hypercalcaemia , adverse events , and serious adverse events was similar between groups receiving paricalcitol versus placebo . INTERPRETATION Addition of 2 μg/day paricalcitol to RAAS inhibition safely lowers residual albuminuria in patients with diabetic nephropathy , and could be a novel approach to lower residual renal risk in diabetes . FUNDING Abbott",
"In a double-blind , r and omized , placebo-controlled , crossover trial , 23 middle-aged patients with mild to moderate essential hypertension were given an oral calcium supplement ( 1 g/day ) for 8 weeks . At the end of this period , eight patients continued with this treatment for an additional 2 weeks but were also given 0.5 micrograms/day of 1,25-(OH)2 vitamin D3 . In the 21 patients who completed the study , arterial pressure during the calcium-supplemented phase was almost identical to that of the placebo phase . In eight patients , mean arterial pressure ( MAP ) had changed by greater than 5 mmHg at the end of the calcium-supplemented period , compared with the end of the placebo phase ( six patients showed an increase in MAP and two a decrease ) . Changes in arterial pressure were unrelated to age , plasma ionized calcium , parathyroid hormone ( PTH ) , plasma renin activity ( PRA ) , plasma aldosterone , 24-h urinary calcium , sodium and potassium and were only weakly related to body weight . In the eight patients who continued with the treatment of calcium plus 1,25-(OH)2 vitamin D3 after the 8-week study period , arterial pressure changed very little and not significantly . These results do not support the suggestion that calcium supplements lower arterial pressure in middle-aged subjects with mild to moderate essential hypertension",
"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 )",
"AIMS To test whether a single large dose of vitamin D2 can improve endothelial function in patients with Type 2 diabetes mellitus and low serum 25-hydroxyvitamin D levels . METHODS Double-blind , parallel group , placebo-controlled r and omized trial . A single dose of 100,000 IU vitamin D2 or placebo was administered to patients with Type 2 diabetes over the winter , when levels of circulating 25-hydroxyvitamin D were likely to be lowest . Patients were enrolled if their baseline 25-hydroxyvitamin D level was Endothelial function and blood pressure were measured and fasting blood sample s were taken at baseline and 8 weeks after administration of vitamin D. RESULTS Forty-nine per cent of subjects screened had 25-hydroxyvitamin D levels Vitamin D supplementation increased 25-hydroxyvitamin D levels by 15.3 nmol/l relative to placebo and significantly improved flow mediated vasodilatation ( FMD ) of the brachial artery by 2.3 % . The improvement in FMD remained significant after adjusting for changes in blood pressure . Vitamin D supplementation significantly decreased systolic blood pressure by 14 mmHg compared with placebo ; this did not correlate with change in FMD . CONCLUSIONS Vitamin D insufficiency is common in patients with Type 2 diabetes during winter in Scotl and . A single large dose of oral vitamin D2 improves endothelial function in patients with Type 2 diabetes and vitamin D insufficiency",
"Vitamin D recently has been proposed to play an important role in a broad range of organ functions , including cardiovascular ( CV ) health ; however , the CV evidence -base is limited . We prospect ively analyzed a large electronic medical records data base to determine the prevalence of vitamin D deficiency and the relation of vitamin D levels to prevalent and incident CV risk factors and diseases , including mortality . The data base contained 41,504 patient records with at least one measured vitamin D level . The prevalence of vitamin D deficiency ( ≤30 ng/ml ) was 63.6 % , with only minor differences by gender or age . Vitamin D deficiency was associated with highly significant ( p prevalence of diabetes , hypertension , hyperlipidemia , and peripheral vascular disease . Also , those without risk factors but with severe deficiency had an increased likelihood of developing diabetes , hypertension , and hyperlipidemia . The vitamin D levels were also highly associated with coronary artery disease , myocardial infa rct ion , heart failure , and stroke ( all p with incident death , heart failure , coronary artery disease/myocardial infa rct ion ( all p stroke ( p = 0.003 ) , and their composite ( p vitamin D deficiency in the general healthcare population and an association between vitamin D levels and prevalent and incident CV risk factors and outcomes . These observations lend strong support to the hypothesis that vitamin D might play a primary role in CV risk factors and disease . Given the ease of vitamin D measurement and replacement , prospect i ve studies of vitamin D supplementation to prevent and treat CV disease are urgently needed",
"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",
"BACKGROUND Vitamin D insufficiency was shown to be associated with adverse musculoskeletal and nonskeletal outcomes in numerous observational studies . However , some studies did not control for confounding factors such as age or seasonal variation of 25-hydroxyvitamin D [ 25(OH)D ] . OBJECTIVE We sought to determine the effect of vitamin D status on health outcomes . DESIGN Healthy community-dwelling women ( n = 1471 ) with a mean age of 74 y were followed in a 5-y trial of calcium supplementation . 25(OH)D was measured at baseline in all women . Skeletal and nonskeletal outcomes were evaluated according to seasonally adjusted vitamin D status at baseline . RESULTS Fifty percent of women had a seasonally adjusted 25(OH)D concentration or = 50 nmol/L. Women with a seasonally adjusted 25(OH)D concentration incidence of stroke and cardiovascular events that did not persist after adjustment for between-group differences in age or comorbidities . Women with a seasonally adjusted 25(OH)D concentration adverse consequences for any musculoskeletal outcome , including fracture , falls , bone density , or grip strength or any nonskeletal outcomes , including death , myocardial infa rct ion , cancer , heart failure , diabetes , or adverse changes in blood pressure , weight , body composition , cholesterol , or glucose . CONCLUSIONS Vitamin D insufficiency is more common in older , frailer women . Community-dwelling older women with a seasonally adjusted 25(OH)D concentration placebo-controlled trials are needed to determine whether vitamin D supplementation in individuals with vitamin D insufficiency influences health outcomes . This trial was registered at www.anzctr.org.au as ACTRN 012605000242628"
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BACKGROUND Painful Bladder Syndrome/Interstitial Cystitis ( PBS/IC ) occurs predominantly in women . It is a poorly-understood condition with symptoms of bladder pain , urinary frequency , urgency and nocturia . Treatments for PBS/IC include dietary/lifestyle interventions , oral medication , intravesical instillations and , in some cases , surgery . Success rates are generally modest and there is little consensus as to the best form of treatment for this condition . OBJECTIVES To assess the effectiveness of intravesical treatment for PBS/IC . SEARCH STRATEGY We search ed the Cochrane Incontinence Group specialised trials register ( 30 May 2006 ) as well as reference lists of all selected trials . Recognised research ers in the field were contacted for any additional relevant material . SELECTION CRITERIA R and omised or quasi-r and omised controlled trials were included in the review if they had recruited participants with a clinical diagnosis of PBS/IC and if at least one arm of the trial was treatment with an intravesical preparation . Outcome measures were pre-determined , the primary ones being the effect on pain and bladder capacity . Others included symptomatic response to treatment , quality -of-life assessment , economic factors and adverse events . DATA COLLECTION AND ANALYSIS Two review ers independently assessed trial eligibility and quality , then extracted relevant data from the studies . MAIN RESULTS Nine eligible trials were identified - six parallel group , one incomplete cross-over and two cross-over trials - with a total of 616 participants . Six trials compared an ' active ' instillation with placebo instillation , two compared different types of instillation , and one was a comparison of an instillation plus bladder training versus bladder training alone . Altogether , the review included trials of six different types of intravesical instillation : Resiniferatoxin , Dimethyl sulfoxide , BCG , pentosanpolysulphate , oxybutin , and alkalinisation of urine pH. Confidence intervals were generally wide . Resiniferatoxin was not associated with sustained differences in the review outcomes reported but pain during instillation and withdrawal from treatment was significantly more common . The data available about Dimethyl sulfoxide ( DMSO ) were very limited but with no apparent differences from placebo . Groups treated with BCG tended to report less pain and fewer general symptoms . Although adverse events were commonly reported , these were no more common after BCG than after placebo instillation . The few data about Pentosanpolysulphate tended to favour the actively treated , but with wide confidence intervals ; there was little information about adverse events . Oxybutinin instillation was associated with increased bladder capacity , reduced frequency , improved quality of life scores and fewer drop-outs . Alkalinisation of urine pH did not make any clear difference , but with potentially wide confidence intervals . AUTHORS ' CONCLUSIONS Overall , the evidence base for treating PBS/IC using intravesical preparations is limited and the potential for meta- analysis reduced by variation in the outcome measures used . The quality of trial reports was mixed and in some cases this precluded any meaningful data extraction . BCG and oxybutin are reasonably well-tolerated and evidence is most promising for these . Resiniferatoxin showed no evidence of effect for most outcomes and caused pain , which reduced treatment compliance . There is little evidence for the other treatments included in this review . R and omised controlled trials are still needed and study design should incorporate outcomes that are most relevant to these with PBS/IC and should be st and ardised
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[
"Interstitial cystitis ( IC ) is a bladder syndrome of unknown etiology . The cause of IC is most likely multifactorial and includes genetic and environmental factors . Various pathophysiological changes in the bladder , pelvis , and peripheral and central nervous systems have been identified , and this has led to the emergence of biologically specific treatment modalities . Interstitial cystitis is being diagnosed with increasing frequency ; however , current diagnostic criteria are non-uniform , and there is significant overlap between chronic pelvic pain syndromes in men and women , interstitial cystitis , recurrent \" cystitis , \" and the overactive bladder syndrome . The diagnosis of interstitial cystitis can be made clinical ly and by cystoscopy and hydrodistension . The sensitivity and specificity of urinary markers and the potassium sensitivity test have not been prospect ively studied",
"PURPOSE Interstitial cystitis is a severe debilitating bladder disease characterized by unrelenting pelvic pain and urinary frequency . A prospect i ve , double-blind , placebo controlled study of the use of intravesical bacillus Calmette-Guerin ( BCG ) in the treatment of interstitial cystitis was recently completed with a mean followup of 8 months . Results demonstrated a 60 % BCG response rate , compared to a 27 % placebo response rate . We now report the long-term followup results of those patients who received intravesical BCG . MATERIAL S AND METHODS Subjects r and omized to receive BCG were followed at routine intervals with question naires and voiding diaries identical to those in the blinded study . Adverse events were closely monitored in the treatment and followup phases of the study . Subject baseline values were compared to followup data . RESULTS Of the BCG responders mean followup was 27 months ( range 24 to 33 ) , and 8 of 9 ( 89 % ) continue to have an excellent response in all parameters measured . The global interstitial cystitis survey improved 70 % , daily voids decreased 31 % , nocturia improved 54 % , mean voided volume increased 61 % , pelvic pain decreased 81 % , vaginal pain decreased 71 % , urgency decreased 71 % and dysuria decreased 82 % . Overall well-being improved 54 % and the R and -36 quality of life survey overall improved 64 % . In 86 % of the patients ( 6 of 7 ) dyspareunia resolved . Of the initial BCG nonresponders there was no significant difference in interstitial cystitis symptomatology from baseline to last followup , suggesting that BCG does not worsen interstitial cystitis symptoms . No long-term adverse events from BCG were noted . CONCLUSIONS Intravesical Tice BCG is safe , effective and durable in the treatment of interstitial cystitis . Of those patients who received only 6 weekly treatments and responded favorably 89 % continue to have an excellent response with followup ranging from 24 to 33 months",
"OBJECTIVE To evaluate the therapeutic efficacy of intravesical pentosanpolysulphate ( PPS ) compared with placebo in patients with interstitial cystitis ( IC ) . PATIENTS AND METHODS Twenty patients who fulfilled the diagnostic criteria for IC participated in a double-blind placebo-controlled study ; 10 received intravesical PPS ( 300 mg in 50 mL of 0.9 % sodium chloride ) applied twice a week for 3 months and the other 10 received a placebo . Symptomatic relief and objective variables ( bladder capacity voiding volumes and urinary frequency ) were assessed after 3 months and the long-term outcome of those continuing treatment was determined . RESULTS Of the patients treated with PPS , four gained significant symptomatic relief compared with only two receiving placebo . Only the urodynamic bladder capacity showed a statistically significant increase in patients treated with PPS ( P = 0.047 ) . At 18 months from the start of the study , the symptoms were relieved in eight patients while still receiving PPS instillations and in four without treatment . CONCLUSIONS These results suggest that intravesical PPS is an effective option for the treatment of IC and shows that the intravesical application of PPS is a safe treatment with no important side-effects",
" In March 2003 experts on interstitial cystitis ( IC ) from around the world met in Kyoto , Japan for a series of workshops intended to define areas of agreement and difference in the approach to this disease . This workshop explored the diagnostic criteria IC in the clinical and research setting s. The NIDDK criteria are used almost universally for research but there is tremendous disparity in the clinics and no consensus at all as to the best practice in diagnosing IC for clinical purpose s. Throughout the world many physicians use the NIDDK research criteria for clinical diagnosis ; in some countries this is st and ard . Undoubtedly , this m and ates under-diagnosis and denies treatment to many patients . Still , a majority feel that one diagnostic system is m and atory to promote clarity in communication . The group called for two initiatives to help advance this area of controversy : ( 1 ) a large-scale , prospect i ve study critically examining the role of cystoscopy , bladder distention , and biopsy in the diagnosis of IC ; ( 2 ) a concerted effort to develop a single evidence -based guideline or algorithm that would be flexible enough to meet the needs of clinicians , research ers , and patients",
"PURPOSE Present therapeutic approaches to control hypersensitive disorder of the lower urinary tract and bladder pain are clinical ly and scientifically unsatisfactory . We performed a r and omized placebo controlled study with followup after 1 and 3 months using intravesical resiniferatoxin to treat hypersensitive disorder and bladder pain . MATERIAL S AND METHODS We prospect ively r and omized 18 patients into 2 groups to receive a single dose of 10 nM. resiniferatoxin intravesically ( group 1 ) or a placebo saline solution only ( group 2 ) . All patients had at least a 6-month history of frequency , nocturia , urgency and symptoms of pelvic pain as well as no urinary tract infection within the last 3 months , functional disorders of the lower urinary tract , or other vesical or urethral pathology . Pretreatment voiding pattern and pain score were recorded . Patients were evaluated after 30 days ( primary end point ) and 3 months ( secondary end point ) . RESULTS The 2 groups were adequately homogeneous in regard to patient age , sex ratio , disease duration , voiding pattern and pain score . At the primary end point mean frequency plus or minus st and ard error of mean was decreased from 12 . 444 + /- 0.70 voids to 7.111 + /- 0.67 and nocturia from 3.777 + /- 0 . 27 to 1.666 + /- 0.16 ( p mean frequency in group 1 at the secondary end point to 10.444 + /- 0.94 voids ( p placebo . Mean pain score significantly decreased in group 1 at the primary end point from 5.555 + /- 0.29 to 2.666 + /- 0.23 ( p 0.05 ) . No statistically significant improvement in mean pain score was observed in placebo group 2 . During resiniferatoxin infusion 4 group 1 patients noticed a light warm or burning sensation at the suprapubic and /or urethral level . CONCLUSIONS Intravesical resiniferatoxin may significantly improve the voiding pattern and pain score in patients with hypersensitive disorder and bladder pain . Because resiniferatoxin did not cause a significant warm or burning sensation at the suprapubic and /or urethral level , it may be considered a new strategy for treating hypersensitive disorder and bladder pain . However , further studies are necessary to confirm our results and define the resiniferatoxin mechanism of action , dose and necessary treatment schedule",
"PURPOSE We compared intravesical bacillus Calmette-Guerin ( BCG ) to placebo instillations in patients with treatment refractory interstitial cystitis ( IC ) . MATERIAL S AND METHODS Subjects who met the National Institutes of Health-National Institute for Diabetes and Digestive and Kidney Diseases criteria for IC , and reported at least moderate pain and frequency for a minimum of 6 months before study entry , were r and omized to 6 weekly double-blinded intravesical instillations of either BCG or placebo , and then followed for a total of 34 weeks . The primary outcome was a patient reported global response assessment at week 34 , supplemented with medications for IC during weeks 31 to 34 . Secondary outcomes included a 24-hour voiding diary , pain , urgency , vali date d IC symptom indexes and adverse events . The target sample size was 260 participants , design ed to detect a difference in response rates between placebo and BCG of 30 % and 50 % , respectively . RESULTS A total of 265 participants were r and omized and 17 ( 6 % ) patients withdrew from study . The response rates for the primary outcome were 12 % for placebo and 21 % for BCG ( p = 0.062 ) . Small improvements were observed for all secondary outcomes , some more so with BCG , but these differences were of borderline statistical significance . Although a large number of adverse events were reported in the BCG arm , there was no statistically significant difference between the treatment arms in overall adverse event rates . CONCLUSIONS Although the BCG safety profile was acceptable , the response rate for the primary outcome was low . Effective medical treatment for patients with moderate to severe interstitial cystitis remains elusive",
"Objective : To determine the safety and tolerability of intravesical resiniferatoxin ( RTX ) in interstitial cystitis ( IC ) patients . Material s and Methods : IC patients were instilled with 50 cc of test solution containing either placebo , 0.05 μM or 0.10 μM RTX in the bladder . Plasma concentration of RTX and its degradant resiniferonol 9- , 13- , 14-orthophenylacetate was measured . Immediate post-treatment blood sampling and cystoscopy were performed . Symptoms were evaluated before treatment , at 4- and at 12-week follow-ups , using VAS indicator for pain , voiding diary , and O’Leary ’s IC symptom/problem indices . Results : Among 22 patients observed ( ten in 0.10 μM RTX , eight in 0.05 μM RTX , and four in placebo groups ) , the most commonly reported adverse event was pain during instillation ( 80.0 % , 87.5 % , and 25.0 % ) . No serious adverse events were reported . Conclusions : Use of intravesical RTX in IC patients is associated with important tolerability issues but safe at 0.10 μM and 0.05",
"To provide evidence for the clinical efficacy of changes in urinary pH on the pain associated with interstitial cystitis ( IC )",
"PURPOSE Interstitial cystitis is a debilitating bladder disease of unknown etiology with no cure . A recent report suggested that bacillus Calmette-Guerin ( BCG ) may be effective in the treatment of interstitial cystitis . A r and omized , prospect i ve , double-blind , placebo controlled trial to evaluate the safety and efficacy of intravesical BCG in treating interstitial cystitis was done . MATERIAL S AND METHODS Patients meeting the National Institute of Arthritis , Diabetes and Digestive and Kidney Diseases criteria for interstitial cystitis received 6 weekly instillations of Tice strain BCG or placebo . Periodic question naires , voiding diaries and cystometrograms were obtained . A total of 30 evaluable subjects was enrolled in the study with a mean followup of 8 months ( range 6 to 13 ) . Based on an exit question naire a responder was defined as one who rated the interstitial cystitis symptoms as moderately improved or better . RESULTS A 60 % BCG response rate was noted , compared to a 27 % placebo response rate . Minimum voided volume and quality of life improved in the BCG group compared to placebo . Adverse events were similar in each group , mostly irritative in nature , and no significant systemic events were noted . CONCLUSIONS Intravesical Tice strain BCG appears to be safe and efficacious in the treatment of interstitial cystitis . Additional studies must be performed to confirm the results of this pilot study",
"PURPOSE Interstitial cystitis is a painful bladder condition of unknown etiology and poorly understood pathophysiology . Current therapies have met with limited success . Vanilloid receptor agonists such as resiniferatoxin ( RTX ) desensitize C-fibers that transmit pain ; it is hypothesized that such drugs will be effective in the treatment of interstitial cystitis and painful bladder syndrome by decreasing the pain that leads to urinary frequency and urgency . MATERIAL S AND METHODS A r and omized , double-blind , placebo controlled study was conducted in 163 patients with interstitial cystitis . Participants were r and omly assigned to receive a single intravesical dose of 50 ml of either RTX 0.01 microM , 0.05 microM , 0.10 microM , or placebo . Safety and efficacy was evaluated over 12 weeks . The primary efficacy endpoint was the Global Response Assessment , a 7-point scale rating overall change in symptoms of interstitial cystitis after 4 weeks . Secondary efficacy endpoints included reduction in pain , urgency , frequency , nocturia , average void volume , and the O'Leary-Sant Symptom and Problem Indexes . RESULTS RTX did not improve overall symptoms , pain , urgency , frequency , nocturia , or average void volume during 12 weeks followup . RTX result ed in a dose-dependent increase in the incidence of instillation pain , but was otherwise generally well tolerated . CONCLUSIONS In the largest prospect i ve , r and omized clinical trial reported to date with intravesical vanilloid therapy , single administration of RTX at doses of 0.01 microM to 0.10 microM was not effective in patients with interstitial cystitis",
"PURPOSE We conducted a prospect i ve , double-blind study with a crossover design of intravesical bacillus Calmette-Guerin ( BCG ) and dimethyl sulfoxide to determine whether patients with classic and nonulcer interstitial cystitis , respectively , might benefit from either regimen . MATERIAL S AND METHODS A total of 21 patients , including 11 with classic and 10 with nonulcer interstitial cystitis , r and omly underwent treatments with intravesical BCG or dimethyl sulfoxide and , if not improved , were treated with the other substance after a washout period . All 21 patients were evaluated with symptom question naires , including a visual analog pain scale and voiding diaries . RESULTS Regardless of regimen , there was no improvement in maximal functional capacity . There was a reduction in urinary frequency following dimethyl sulfoxide treatment but only in the classic subtype ( p pain decrease was noted in classic ( p maximal functional capacity but result ed in a significant reduction in pain and urinary frequency , although only in patients with classic interstitial cystitis",
"PURPOSE Present therapeutic approaches to control bladder pain are clinical ly and scientifically unsatisfactory , and pain in the lower urinary tract remains a challenge even to the skilled urologist . A r and omized placebo controlled study was done to evaluate intravesical capsaicin for severe bladder pain . Followup was 6 months . MATERIAL S AND METHODS A total of 36 patients was prospect ively r and omized into those receiving 10 microM. intravesical capsaicin twice weekly for 1 month ( group 1 ) or placebo ( group 2 ) . All patients had pelvic pain for at least 6 months , and had no urinary tract infection within the last 3 months , functional disorders of the lower urinary tract , or other vesical or urethral pathology . Pretreatment voiding pattern and pain score were recorded . Patients were evaluated immediately at the end of treatment ( primary end point ) and 6 months later ( secondary end point ) . RESULTS Both groups were adequately homogeneous with regard to age , sex ratio , duration of disease , voiding pattern and pain score . At both end points group 1 had significant improvement in frequency and nocturia but no improvement in urgency . No change was noted in group 2 . A significant decrease in pain score was found in group 1 at the primary ( mean plus or minus st and ard deviation 3.22 + /- 0.42 , p placebo group , in which the pretreatment pain score ( 5.47 + /- 0.37 ) was decreased at the primary ( 4.47 + /- 0.36 , p capsaicin on voiding pattern in patients with hypersensitive disorders ( frequency and nocturia ) . We could not confirm improvement in pain score after capsaicin treatment compared to placebo . Possibly a larger dose of capsaicin would be more effective in controlling pain and neurological disease of the bladder",
"PURPOSE We assess the efficacy of intravesical administration of oxybutynin chloride in patients with interstitial cystitis . MATERIAL S AND METHODS The study included 36 women with a mean age of 45 years with a diagnosis of interstitial cystitis . Patients were treated with gradual intravesical instillation of saline oxybutynin solution ( oxybutynin group ) or gradual filling of simple saline ( control group ) . Evaluation parameters consisted of symptom problem index , voids per day , volume per void , functional bladder capacity , volume at first sensation , cystometric bladder capacity and cystometric volume at first sensation . RESULTS Statistically significant improvement of all evaluated parameters was found in both groups . When comparing the outcomes statistically significant improvement of parameters favored the oxybutynin group . CONCLUSIONS Bladder training alone produces a satisfactory result by gradually exp and ing the bladder , and an additional statistically significant improvement is evident with intravesical oxybutynin",
"PURPOSE A psychometric analysis of the University of Wisconsin Interstitial Cystitis Scale was conducted on 30 females previously enrolled in a phase II double-blind r and omized controlled trial evaluating the efficacy of six weekly intravesical instillations of TICE BCG . The analyses were to : ( 1 ) evaluate the adequacy of the seven individual IC component items for measuring the range of patient responses ; ( 2 ) verify the 2-factor ( IC versus reference ) construct of the scale ; ( 3 ) evaluate the internal consistency and reliability of the IC items ; ( 4 ) better define the scale 's applicability and limitations ; and ( 5 ) if possible , make recommendations for improvements in the scale . MATERIAL S AND METHODS St and ard psychometric analyses were used to perform the evaluation , and included descriptive analysis of individual items , computing of item-total correlations and Cronbach 's internal consistency measures , and the application of factor and Rasch analyses . RESULTS The original 7-item IC scale was found to have ceiling effects that could limit its use in detecting small therapeutic differences . It was also found that the Pelvic item originally assigned to the reference set of items of the scale should be included as an IC item when used in a comparable IC population . After including this item into the IC scale Cronbach 's alpha was 0.84 , compared with 0.82 . CONCLUSIONS The UW-IC Scale has psychometric properties similar to other measurement instruments used in clinical research , and appears worthy of further study in well-characterized IC population s. The reference items suggest that IC patients do not indiscriminately report high values for generalized body complaints , but do so on bladder related symptoms as recorded by the IC items of the scale . Although the scale has limitations it appears applicable for use in future IC intervention clinical trials",
"To evaluate the effectiveness of dimethyl sulfoxide in the treatment of patients with biopsies suggestive of interstitial cystitis , 33 patients underwent a controlled crossover trial . Patients were allocated r and omly to receive 50 per cent dimethyl sulfoxide or placebo ( saline ) . The medication was administered intravesically every 2 weeks for 2 sessions of 4 treatments each . Response was assessed urodynamically and symptomatically . Thirty women and 3 men ( mean age 48 years and mean duration of symptoms 5.5 years ) were entered into the study . No significant side effects to dimethyl sulfoxide were noted . When assessed subjectively , 53 per cent of dimethyl sulfoxide treated patients were markedly improved compared to 18 per cent of the placebo treated patients . Of the dimethyl sulfoxide group 93 per cent had objective improvement versus 35 per cent of the placebo group . Thus , dimethyl sulfoxide proved to be superior to placebo in the objective and subjective improvement of patients with interstitial cystitis"
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Background To counteract decline in physical performance and physical activity in older patients during hospitalization , multiple physical interventions were developed . However , it is unknown whether these are effective in this particular population . This systematic review aim ed to identify the effect of physical interventions on physical performance and physical activity in older patients during hospitalization . Methods The systematic search included PubMed , EMBASE , Cinahl , the Trials data base of The Cochrane Library and SPORTd iscus from inception to 22 November 2017 . Studies were included if the mean age of the patient cohort was 65 years and older and the effect of physical interventions on physical performance or physical activity was evaluated during hospitalization . Results Fifteen r and omized controlled trials met the inclusion criteria . Overall , the effect of physical interventions on physical performance was inconsistent . Patient tailored interventions , i.e. continuously adapted to the capabilities of the patient were not found to be superior over interventions that were not . Physical activity as outcome measure was not addressed . Reporting of intensity of the interventions and adherence were frequently lacking . Conclusions Evidence for the effect of physical interventions on physical performance in older patients during hospitalization was found uncertain . Further research on the efficacy of the intervention is needed , comparing types of intervention with detailed reporting of frequency , intensity and duration
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"Background Improving mobility in elderly persons is a primary goal in geriatric rehabilitation . Self-regulated exercises with instruction leaflets are used to increase training volume but adherence is often low . Exergames may improve adherence . This study therefore compared exergames with self-regulated exercise using instruction leaflets . The primary outcome was adherence . Secondary outcomes were enjoyment , motivation and balance during walking . Methods Design : single center parallel group non-blinded r and omized controlled trial with central stratified r and omization . Setting : center for geriatric inpatient rehabilitation . Included were patients over 65 with mobility restrictions who were able to perform self-regulated exercise . Patients were assigned to self-regulated exercise using a ) exergames on Windows Kinect ® ( exergame group EG ) or b ) instruction leaflets ( conventional group CG ) . During two 30 min sessions physical therapists instructed self-regulated exercise to be conducted twice daily during thirty minutes during ten working days . Patients reported adherence ( primary outcome ) , enjoyment and motivation daily . Balance during walking was measured blind before and after the treatment phase with an accelerometer . Analysis was by intention to treat . Repeated measures mixed models and Cohen ’s d effect sizes ( ES , moderate if > 0.5 , large if > 0.8 ) with 95 % CIs were used to evaluate between-group effects over time . Alpha was set at 0.05 . Results From June 2014 to December 2015 217 patients were evaluated and 54 included , 26 in the EG and 28 in the CG . Adverse effects were observed in two patients in the EG who stopped because of pain during exercising . Adherence was comparable at day one ( 38 min . in the EG and 42 min . in the CG ) and significantly higher in the CG at day 10 ( 54 min . in the CG while decreasing to 28 min . in the EG , p = 0.007 , ES 0.94 , 0.39–0.151 ) . Benefits favoring the CG were also observed for enjoyment ( p = 0.001 , ES 0.88 , 0.32 – 1.44 ) and motivation ( p = 0.046 , ES 0.59 , 0.05–1.14 ) ) . There was no between-group effect in balance during walking . Conclusions Self-regulated exercise using instruction leaflets is superior to exergames regarding adherence , enjoyment and motivation in a geriatric inpatient rehabilitation setting . Effects were moderate to large . There was no between group difference in balance during walking . Trial registration Clinical Trials.gov , NCT02077049 , 6 February 2014",
"BACKGROUND Several studies on the effect of physical exercise on activities of daily living ( ADL ) for people with dementia exist ; yet , data concerning the specific context of acute psychiatric hospitals remain scant . This study measured the effect of a physical exercise program on ADL scores in patients with moderate to severe dementia hospitalized in an acute psychiatric ward . METHODS A multicenter clinical trial was conducted in five Swiss and Belgian psychiatric hospitals . Participants were r and omly allocated to either an experimental group ( EG ) or a control group ( CG ) . Members of the EG received 20 physical exercise sessions ( strengthening , balance , and walking ) over a four-week period while members of the CG participated in social interaction sessions of equivalent duration and frequency , but without physical exercise . The effect of exercise on ADL was measured by comparing scores of the Barthel Index and the Functional Independence Measure in the EG and CG before and after the intervention , and two weeks later . RESULTS Hundred and sixty patients completed the program . Characteristics of participants of both groups were similar at the inception of the study . The mean ADL score of EG decreased slightly over time , whereas that of the CG significantly decreased compared to initial scores . Overall differences between groups were not significant ; however , significant differences were found for mobility-related items . CONCLUSIONS ADL scores in elderly with moderate to severe dementia deteriorate during acute psychiatric hospitalization . An exercise program delays the loss of mobility but does not have a significant impact on overall ADL scores ",
"UNLABELLED Aging population , increases the number of major abdominal surgery ( MAS ) performed in the elderly . Main goal of physiotherapy after that surgery is prevention postoperative complications and reduction of functional limitation . The aim of the study was to asses functional status elderly people after MAS during early postoperative physiotherapy . MATERIAL AND METHODS In a prospect i ve r and omized study involved 34 patients scheduled for elective MAS , aged 65 + . Patients were r and omly assigned to receive PNF or conventional physiotherapy . The study included forced spirometry ( FVC , FEV1 , PEF ) and functional tests ( gait speed , up&go ) . Measurements were performed before surgery and the fourth day after surgery . Also analyzed age , sex , BMI and the level of postoperative independence ( postoperative independence scale SAP ) . Kolmogorow- Smirnow test was used to check normal distribution , t-Student was used to check whether two sets of data differ significantly , and r-Pearsons for correlations testing . p values time of gait speed test and up and go test was significant longer in comparison to preoperative value . FVC% , FEV1 % , PEF% values was decrease . In the PNF group was found significantly higher postoperative independence(SAP ) and shorter length of stay in hospital compared to conventional physiotherapy group . Results of SAP and functional tests were significantly positive correlated . CONCLUSIONS Major abdominal surgery decrees efficiency of walking and lung ventilation after 65 year old in early postoperative period . Some techniques of the PNF concept used in improving older patients after the MAS may favourably affect the postoperative increase independence and reduce the time of hospitalization",
"Objective : To evaluate the effect of progressive resistance strength training as additional training measured on functional outcomes in older hospitalized patients . Design : A single-blinded r and omized controlled trial . Setting : Department of Geriatric Rehabilitation in university hospital . Participants : A sample of 71 patients were successively included and r and omized either to the treatment group ( TG ) ( n = 36 ) or the control group ( CG ) ( n = 35 ) . Fifteen participants dropped out ( TG n = 7 ; CG n = 8) , leaving 56 participants with a mean age of 79 ( SD 7 ) . Intervention : Participants in the treatment group were treated in groups with progressive resistance strength training in addition to st and ard care . Progressive resistance strength training of the lower extremities was performed in three sets of 12–15 repetitions , intensity 60–70 % of one repetition maximum , in four 50-minute sessions per week . Main measures : The effect was evaluated by timed up & go test , 30-second chair-st and test , 10-m walk test , three tasks ( transfer , walking , stairs ) of the Barthel Index , and use of walking aids . Results : Significant improvements in the 10-m walk test ( P ( P = 0.01 ) were demonstrated within the treatment group but not in the control group . Both groups had significant improvements in timed up & go , 30-second chair-st and ( modified ) and Barthel Index ( transfer and walking ) . No significant difference was found between groups except for the Barthel Index ( stairs ) ( P = 0.05 ) . Analysis by the mixed-effects model showed that the treatment group improved more than the control group in all outcome variables . Conclusion : The results indicate that for older hospitalized patients progressive resistance strength training as additional training may have an effect compared to st and ard care , but no statistically significant effects were demonstrated when measured by functional outcomes",
"OBJECTIVES To examine the proportion of time spent in three levels of mobility ( lying , sitting , and st and ing or walking ) by a cohort of hospitalized older veterans as measured by vali date d wireless accelerometers . DESIGN A prospect i ve , observational cohort study . SETTING One hundred fifty-bed Department of Veterans Affairs hospital . PARTICIPANTS Forty-five hospitalized medical patients , aged 65 and older who were not delirious , did not have dementia , and were able to walk in the 2 weeks before admission were eligible . MEASUREMENTS Wireless accelerometers were attached to the thigh and ankle of patients for the first 7 days after admission or until hospital discharge , whichever came first . The mean proportion of time spent lying , sitting , and st and ing or walking was determined for each hour after hospital admission using a previously vali date d algorithm . RESULTS Forty-five male patients ( mean age 74.2 ) with a mean length of stay of 5.1 days generated 2,592 one-hour periods of data . A baseline functional assessment indicated that 35 ( 77.8 % ) study patients were willing and able to walk a short distance independently . No patient remained in bed the entire measured hospital stay , but on average , 83 % of the measured hospital stay was spent lying in bed . The average amount of time that any one individual spent st and ing or walking ranged from a low of 0.2 % to a high of 21 % , with a median of 3 % , or 43 minutes per day . CONCLUSION This is the first study to continuously monitor mobility levels early during a hospital stay . On average , older hospitalized patients spent most of their time lying in bed , despite an ability to walk independently",
"[ Purpose ] The aim of this study was to examine the effects of horse riding exercise using a horse riding simulator ( HRS ) and a ball on static and dynamic balance of elderly people . [ Methods ] Thirty-two elderly people hospitalized in geriatric hospitals were r and omly assigned to the HRS exercise group or the ball exercise groups , and they performed exercise for eight weeks . [ Results ] The length of postural sway during quite st and ing with and without eyes closed significantly decreased in both groups after the exercises and there was no significant difference between both groups in the Romberg test . In the functional reach test ( FRT ) , there were significant increases in distance in both groups after the exercises , and the distance of the HRS exercise group was significantly greater than that of the ball exercise group . In the Timed Up & Go test ( TUG ) and Timed 10-meter walk test ( 10MWT ) , the time significantly decreased in both groups , and there was a more significant decrease in the HRS exercise group than in the ball exercise group . [ Conclusion ] The results of this study indicate that HRS and ball exercises may improve the balance and gait ability of elderly people hospitalized in nursing homes or geriatric hospitals",
"QUESTION What are the effects of additional exercise on hospital and patient outcomes for acutely-hospitalised older medical patients ? DESIGN Controlled clinical trial . PARTICIPANTS 236 Patients aged 65 or older admitted to an acute care hospital with a medical illness between October 2002 and July 2003 . INTERVENTION The experimental group received usual care plus an individually tailored exercise program administered twice daily from hospital admission to discharge . The control group received usual care only . OUTCOME MEASURES The primary outcome was discharge destination . Secondary outcomes were measures of activity limitation ( Barthel Index , Timed Up and Go , Functional Ambulation Classification ) , length of stay , and adverse events . RESULTS There was no significant effect of the additional exercise program on any outcome . There were no significant differences between groups for the proportion of the patients discharged to home ( RR 0.99 , 95 % CI 0.86 to 1.14 ) or inpatient rehabilitation ( RR 0.76 , 95 % CI 0.30 to 1.51 ) or for measures of activity limitation at hospital discharge . A one day difference in length of stay was identified between groups but this difference was not significant ( p = 0.45 ) . There were no significant differences between groups for adverse events : 28-day readmission ( RR 1.10 , 95 % CI 0.65 to 1.86 ) , patient mortality ( RR 1.15 , 95 % CI 0.16 to 8.0 ) , intensive care admission ( RR 0.16 , 95 % CI 0.01 to 3.13 ) and falls ( RR 0.69 , 95 % CI 0.17 to 2.81 ) . CONCLUSION Additional physiotherapy intervention during hospitalisation did not significantly improve hospital or patient outcomes",
"Background Older adults receiving inpatient rehabilitation have low activity levels and poor mobility outcomes . Increased physical activity may improve mobility . The objective of this Phase II study was to evaluate the feasibility of a r and omized controlled trial ( RCT ) of enhanced physical activity in older adults receiving rehabilitation . Methods Patients admitted to aged care rehabilitation with reduced mobility were r and omized to receive usual care or usual care plus additional physical activity , which was delivered by a physiotherapist or physiotherapy assistant . The feasibility and safety of the proposed RCT protocol was evaluated . The primary clinical outcome was mobility , which was assessed on hospital admission and discharge by an assessor blinded to group assignment . To determine the most appropriate measure of mobility , three measures were trialled ; the Timed Up and Go , the Elderly Mobility Scale and the de Morton Mobility Index . Results The protocol was feasible . Thirty-four percent of people admitted to the ward were recruited , with 47 participants r and omised to a control ( n = 25 ) or intervention group ( n = 22 ) . The rates of adverse events ( death , falls and readmission to an acute service ) did not differ between the groups . Usual care therapists remained blind to group allocation , with no change in usual practice . Physical activity targets were met on weekdays but not weekends and the intervention was acceptable to participants . The de Morton Mobility Index was the most appropriate measure of mobility . Conclusions The proposed RCT of enhanced physical activity in older adults receiving rehabilitation was feasible . A larger multi-centre RCT to establish whether this intervention is cost effective and improves mobility is warranted . Trial registration The trial was registered with the ANZTCR ( ACTRN12608000427370 )",
"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",
"BACKGROUND The purpose of this efficacy study was to measure the dose-response effect of a free weight-based resistance training program by comparing the effects of two training intensities ( low-moderate and high ) of the knee extensor ( KE ) muscles on muscle function , functional limitations , and self-reported disability . METHODS The authors conducted a single-blinded , r and omized , placebo-controlled trial . Twenty-two institutionalized elders ( mean age , 81.5 years ) were assigned to either high-intensity strength training ( HI ; n = 8) , low-moderate intensity strength training ( LI ; n = 6 ) , or weight-free placebo-control training ( PC ; n = 8) . The HI group trained at 80 % of their 1-repetition maximum and the LI group trained at 40 % . All groups performed 3 sets of 8 repetitions , 3 times per week for 10 weeks . Outcome measures included KE maximal strength , KE endurance , and functional performance as assessed by 6-minute walking , chair-rising , and stair-climbing tests , and by self-reported disability . RESULTS KE strength and endurance , stair-climbing power , and chair-rising time improved significantly in the HI and LI groups compared with the PC group . Six-minute walking distance improved significantly in the HI group but not in the LI group compared with the PC group . Changes observed in HI were significantly different from those observed in the LI group for KE strength and endurance and the 6-minute walking test , with a trend in the same direction for chair-rising and stair-climbing . Changes in strength were significantly related to changes in functional outcomes , explaining 37 % to 61 % of the variance . CONCLUSIONS These results show strong dose-response relationships between resistance training intensity and strength gains , and between strength gains and functional improvements after resistance training . Low-moderate intensity resistance training of the KE muscles may not be sufficiently robust from a physiologic perspective to achieve optimal improvement of functional performance . Supervised HI , free weight-based training for frail elders appears to be as safe as lower intensity training but is more effective physiologically and functionally",
"OBJECTIVES To describe the changes in activities of daily living ( ADL ) function occurring before and after hospital admission in older people hospitalized with medical illness and to assess the effect of age on loss of ADL function . DESIGN Prospect i ve observational study . SETTING The general medical service of two hospitals . PARTICIPANTS Two thous and two hundred ninety-three patients aged 70 and older ( mean age 80 , 64 % women , 24 % nonwhite ) . MEASUREMENTS At the time of hospital admission , patients or their surrogates were interviewed about their independence in five ADLs ( bathing , dressing , eating , transferring , and toileting ) 2 weeks before admission ( baseline ) and at admission . Subjects were interviewed about ADL function at discharge . Outcome measures included functional decline between baseline and discharge and functional changes between baseline and admission and between admission and discharge . RESULTS Thirty-five percent of patients declined in ADL function between baseline and discharge . This included the 23 % of patients who declined between baseline and admission and failed to recover to baseline function between admission and discharge and the 12 % of patients who did not decline between baseline and admission but declined between hospital admission and discharge . Twenty percent of patients declined between baseline and admission but recovered to baseline function between admission and discharge . The frequency of ADL decline between baseline and discharge varied markedly with age ( 23 % , 28 % , 38 % , 50 % , and 63 % in patients aged 70 - 74 , 75 - 79 , 80 - 84 , 85 - 89 , and > or = 90 , respectively , P ADL decline before hospitalization ( odds ratio ( OR ) for patients aged > or = 90 compared with patients aged 70 - 74 = 1.26 , 95 % confidence interval ( CI ) = 0.88 - 1.82 ) . In contrast , age was associated with the failure to recover ADL function during hospitalization in patients who declined before admission ( OR for patients aged > or = 90 compared with patients aged 70 - 74 = 2.09 , 95 % CI = 1.20 - 3.65 ) and with new losses of ADL function during hospitalization in patients who did not decline before admission ( OR for patients aged > or = 90 compared with patients aged 70 - 74 = 3.43 , 95 % CI = 1.92 - 6.12 ) . CONCLUSION Many hospitalized older people are discharged with ADL function that is worse than their baseline function . The oldest patients are at particularly high risk of poor functional outcomes because they are less likely to recover ADL function lost before admission and more likely to develop new functional deficits during",
"RATIONALE Exacerbations of chronic obstructive pulmonary disease ( COPD ) acutely reduce skeletal muscle strength and result in long-term loss of functional capacity . OBJECTIVES To investigate whether resistance training is feasible and safe and can prevent deteriorating muscle function during exacerbations of COPD . METHODS Forty patients ( FEV(1 ) 49 + /- 17 % predicted ) hospitalized with a severe COPD exacerbation were r and omized to receive usual care or an additional resistance training program during the hospital admission . Patients were followed up for 1 month after discharge . Primary outcomes were quadriceps force and systemic inflammation . A muscle biopsy was taken in a subgroup of patients to assess anabolic and catabolic pathways . MEASUREMENTS AND MAIN RESULTS Resistance training did not yield higher systemic inflammation as indicated by C-reactive protein levels and could be completed uneventfully . Enhanced quadriceps force was seen at discharge ( + 9.7 + /- 16 % in the training group ; -1 + /- 13 % in control subjects ; P = 0.05 ) and at 1 month follow-up in the patients who trained . The 6-minute walking distance improved after discharge only in the group who received resistance training ( median 34 ; interquartile range , 14 - 61 m ; P = 0.002 ) . In a subgroup of patients a muscle biopsy showed a more anabolic status of skeletal muscle in patients who followed training . Myostatin was lower ( P = 0.03 ) and the myogenin/MyoD ratio tended to be higher ( P = 0.08 ) in the training group compared with control subjects . CONCLUSIONS Resistance training is safe , successfully counteracts skeletal muscle dysfunction during acute exacerbations of COPD , and may up-regulate the anabolic milieu in the skeletal muscle . Clinical trial registered with www . clinical trials.gov ( NCT00877084 )",
"BACKGROUND Major surgical procedures as well as general anesthesia contribute to muscle weakness and posture instability and may result in increased postoperative complications and functional disorders result ing from an elective operation . OBJECTIVES We aim to state the significance of backward walking as a form of interval march training with patients after abdominal aortic aneurysm surgery . MATERIAL AND METHODS Sixty-five patients were r and omly divided into three subgroups and three various models of physiotherapy were applied . The participants were males , aged 65 - 75 years , with stable cardiologic status , absence of neurological disorders , and non-symptomatic aneurysm - non-ruptured , no pain complaints and no motor system impairments . The control group had only routine physiotherapy , since therapeutic groups I and II also had walking exercises , forward in group II and backward in group I. Both experimental groups were applied interval training . The patient data analyzed was as follows : hospitalization period-days ; 6-min walking test-distance ( m ) , training heart rate ( 1/min ) , mean speed ( km/h ) , MET ; spirometry test-FVC(L ) , FEV1(L ) , FEV1/FVC and PEF(L/s ) . RESULTS The hospital stay period in all groups did not vary significantly . Statistical analysis showed that patients with backward walking had a statistically significantly lower reduction of walking distance in the corridor test when compared to the control group ( p mean speed in the control group was noted in comparison with both the forward and backward walking groups ( p average walking speed as well as in heart rate in all observed groups . CONCLUSIONS Physical training applied to patients after major abdominal aortic aneurysm surgery influences sustaining the level of exercise tolerance to a small extent . Both backward and forward walking seem to be alternative methods when compared to classic post-surgery physiotherapy",
"OBJECTIVES To estimate the prevalence of different levels of mobility in a hospitalized older cohort , to measure the degree and rate of adverse outcomes associated with different mobility levels , and to examine the physician activity orders and documented reasons for bedrest in the lowest mobility group . DESIGN A prospect i ve cohort study . SETTING An 800-bed university teaching hospital . PARTICIPANTS Four hundred ninety-eight hospitalized medical patients , aged 70 and older . MEASUREMENTS Using average mobility level , scored from 0 to 12 , the low-mobility group was defined as having a score of 4 or less , intermediate as a score of higher than 4 to 8 , and high as higher than 8 . Outcomes were functional decline , new institutionalization , death , and death or new institutionalization . RESULTS Low and intermediate levels of mobility were common , accounting for 80 ( 16 % ) and 157 ( 32 % ) study patients , respectively . Overall , any activity of daily living ( ADL ) decline occurred in 29 % , new institutionalization in 13 % , death in 7 % , and death or new institutionalization in 22 % of patients in this cohort . When compared with the high mobility group , the low and intermediate groups were associated with the adverse outcomes in a grade d fashion , even after controlling for multiple confounders . The low-mobility group had an adjusted odds ratio ( OR ) of 5.6 ( 95 % confidence interval (CI)=2.9 - 11.0 ) for ADL decline , 6.0 ( 95 % CI=2.5 - 14.8 ) for new institutionalization , 34.3 ( 95 % CI=6.3 - 185.9 ) for death , and 7.2 ( 95 % CI=3.6 - 14.4 ) for death or new institutionalization . The intermediate group had adjusted ORs of 2.5 ( 95 % CI=1.5 - 4.1 ) , 2.9 ( 95 % CI=1.4 - 6.0 ) , 10.1 ( 95 % CI=1.9 - 52.9 ) , and 3.3 ( 95 % CI=1.8 - 5.9 ) for ADL decline , new institutionalization , death , and death or new institutionalization , respectively . Bedrest was ordered at some point during hospitalization in 165 ( 33 % ) patients . For most patients , mobility was limited involuntarily ( bedrest orders ) , and almost 60 % of bedrest episodes in the lowest mobility group had no documented medical indication . CONCLUSION Low mobility and bedrest are common in hospitalized older patients and are important predictors of adverse outcomes . This study demonstrated that the adverse outcomes associated with low mobility and bedrest may be viewed as iatrogenic events leading to complications , such as functional decline",
"OBJECTIVE To evaluate the effects of whole-body resistance training on exercise capacity , health-related quality of life ( HRQOL ) , and muscle strength in patients hospitalized for exacerbation of chronic obstructive pulmonary disease . DESIGN R and omized controlled trial . SETTING University hospital . PARTICIPANTS Patients ( N=46 ) were r and omized to either a control group ( CG ) or training group ( TG ) , and 29 patients completed the study . INTERVENTION Training consisted of weight-lifting exercises for 6 muscle groups in the upper and lower limbs ( 2 sets of 8 repetitions each ) , and the initial load was set at 80 % of the 1-repetition maximum load . MAIN OUTCOME MEASURES Patients were evaluated on the second day of hospitalization , at hospital discharge , and 30 days postdischarge . Patients were evaluated on the basis of the 6-minute walking distance ( 6MWD ) , HRQOL , muscle strength , systemic inflammatory markers , and level of physical activity in daily life ( PADL ) . RESULTS The CG showed a reduction in the strength of lower-limb muscles ( P 6MWD ( P>.05 ) . In contrast , patients from the TG improved strength in the lower-limb muscles and 6MWD during and 30 days after hospitalization ( P impact domain in HRQOL after hospitalization . No improvement in PADL was observed in the TG . Finally , a reduction in the blood levels of inflammatory markers was observed only in the TG after hospitalization . CONCLUSIONS Our results suggest that resistance training during hospitalization improves the 6MWD , HRQOL , and lower-limb muscle strength , without altering the levels of systemic inflammation . However , future research should explore this intervention in larger r and omized trials",
"OBJECTIVE An acute disease is regularly associated with inflammation , decreased food intake , and low physical activity ; the consequence is loss of muscle mass . However , the restoration of muscle tissue is problematic , especially in older patients . Loss of muscle mass leads to further decrease of physical activity which leads , together with recurring disease , to the progressive muscle mass loss accompanied by loss of self-sufficiency . Early nutrition support and physical activity could reverse this situation . Therefore , the aim of this study was to determine whether an active approach based on early nutritional therapy and exercise would influence the development of sarcopenia and impaired self-sufficiency during acute illness . METHODS Two hundred patients > 78 y were admitted to a hospital internal medicine department and participated in a prospect i ve , r and omized controlled study . The patients were r and omized to a control group receiving st and ard treatment ( n = 100 ) or to an intervention group ( n = 100 ) . The intervention consisted of nutritional supplements ( 600 kcal , 20 g/d protein ) added to a st and ard diet and a simultaneous intensive rehabilitation program . The tolerance of supplements and their influence on spontaneous food intake , self-sufficiency , muscle strength , and body composition were evaluated during the study period . The patients were then regularly monitored for 1 y post-discharge . RESULTS The provision of nutritional supplements together with early rehabilitation led to increased total energy and protein intake while the intake of st and ard hospital food was not reduced . The loss of lean body mass and a decrease in self-sufficiency were apparent at discharge from the hospital and 3 mo thereafter in the control group . Nutritional supplementation and the rehabilitation program in the study group prevented these alterations . A positive effect of nutritional intervention and exercise during the hospital stay was apparent at 6 mo post-discharge . CONCLUSIONS The early nutritional intervention together with early rehabilitation preserves muscle mass and independence in ill older patients hospitalized because of acute disease",
"Abstract Purpose : To determine the effect of Vibration Training ( VT ) on functional ability and falls risk among a group of frail older people admitted to an inpatient rehabilitation unit in a regional hospital in New Zeal and . Method : A r and omized controlled trial of 56 participants ( mean 82.01 years in the intervention group and 81.76 years in the control group ) . VT targeting lower limb muscles with a frequency 30–50 Hz occurred three times per week until discharge . Amplitude progressively increased from 2 to 5 mm to allow the programme to be individually tailored to the participant . The control group received usual care physiotherapy sessions . Outcome measures were : Physiological profile assessment ( PPA ) ; and Functional Independence measure ( FIM ) and Modified Falls Efficacy Scale ( MFES ) . Results : There was a statistically significant difference observed between the two groups in terms of FIM score ( F = 5.09 , p = 0.03 ) and MFES ( F = 3.52 , p = 0.007 ) but no difference was observed in terms of PPA scores ( F = 0.96 , p = 0.36 ) . Conclusions : Among older people admitted to an inpatient rehabilitation facility there may be some beneficial effect to the use of VT in conjunction with usual care physiotherapy in terms of improved functional ability . The study design and the small dosage of VT provided may have precluded any change in falls risk among participants . Implication s for Rehabilitation Vibration training ( VT ) may assist in reducing the risk of falling among at risk older people . Current pressures on health systems ( ageing population , reduced hospital length of stay ) necessitate the development of innovative strategies to maximise the rehabilitation potential of older people . Among older people admitted to an inpatient rehabilitation facility there may be some beneficial effect to the use of vibration training in conjunction with usual care physiotherapy in terms of improved functional ability",
"Objective : To evaluate the clinical effectiveness and implementation of a falls prevention exercise programme for preventing falls in the subacute hospital setting . Design : R and omized controlled trial , subgroup analysis . Participants : Patients of a metropolitan subacute/aged rehabilitation hospital who were recommended for a falls prevention exercise programme when enrolled in a larger r and omized controlled trial of a falls prevention programme . Methods : Participants in both the control and intervention groups who were recommended for the exercise programme intervention were followed for the duration of their hospital stay to determine if falls occurred . Participants had their balance , strength and mobility assessed upon referral for the exercise programme and then again prior to discharge . Participation rates in the exercise programme were also recorded . Results : Intervention group participants in this subgroup analysis had a significantly lower incidence of falls than their control group counterparts ( control : 16.0 falls/1000 participant-days , intervention : 8.2 falls/1000 participant-days , log-rank test : P = 0.007 ) . However few differences in secondary balance , strength and mobility outcomes were evident . Conclusion : This exercise programme provided in addition to usual care may assist in the prevention of falls in the subacute hospital setting",
"Purpose : To assess the feasibility of a physiotherapy intervention using an interactive gaming program compared with conventional physiotherapy for hospitalised older people . Methods : R and omised controlled pilot study in a geriatric rehabilitation unit within an acute public hospital . Participants were r and omly allocated to physiotherapy using an interactive gaming program ( n = 22 ) or conventional physiotherapy in a ward-based gym ( n = 22 ) . Feasibility was assessed by comparing the effects of the intervention on clinical outcome measures ( primary outcome : mobility as assessed by the Timed Up and Go test , secondary outcomes : safety , adherence levels , eligibility and consent rates ) . Results : Participants ( n = 44 ) had a mean age of 85 years ( SD 4.5 ) and the majority ( 80 % ) were women . Univariable analyses showed no significant difference between groups following intervention . However , multivariable analyses suggested that participants using the interactive gaming program improved more on the Timed Up and Go test ( p = 0.048 ) than participants receiving conventional physiotherapy . There were no serious adverse events and high levels of adherence to therapy were evident in both groups . Only a small proportion of patients screened were recruited to the study . Conclusions : In this feasibility study , the use of a commercially available interactive gaming program by physiotherapists with older people in a hospital setting was safe and adherence levels were comparable with conventional therapy . Preliminary results suggest that further exploration of approaches using games as therapy for older people could include commonly used measures of balance and function . Implication s for Rehabilitation The use of an interactive gaming program by physiotherapists with hospitalised older people appeared to be safe and result ed in improvements in balance and mobility . Use of these programs may be limited to a relatively small proportion of older people , only those able to use and interested in this technological approach to therapy"
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41173138-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES The paper gives an overview on the components and the polymer chemical aspects of currently used self-etching enamel-dentin primers/adhesives . In addition , the contribution of new adhesives monomers and cross-linkers exhibiting enhanced hydrolytic stability than methacrylates to improve the performance of single-bottle adhesives is discussed . SOURCES Information from original scientific papers or review s about enamel-dentin adhesives , the patent literature concerning dental adhesives and manufacturer information of commercial self-etching adhesives were included in this review . DATA The most efficient self-etching enamel-dentin adhesives are based on strongly acidic adhesive monomers , containing dihydrogenphosphate , phosphonic acids or carboxylic acid groups . Serious problems of single-bottle water-based , strongly acidic self-etching enamel-dentin adhesives arise both from the hydrolytic instability of the methacrylate monomers used and the side reaction of the applied initiator components . CONCLUSIONS The stability of the self-etching enamel-dentin adhesives can be improved by using new acrylic ether phosphonic acids or mono- or difunctional acrylamides , while more stable and compatible components have to be developed in the future
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[
"This study evaluated the effect of the thickness of the adhesive resin layer of two commercially available resin bonding systems on bond strengths ( Single Bond and Liner Bond 2V ) . The adhesive of Single Bond contains ethanol and water as solvents and is applied using the moist-bonding technique . The adhesive of Liner Bond 2V contains no solvents and is applied after a self-etching primer treatment . Forty-six caries-free molars were ground flat to expose the dentin surface and polished with # 800-grit silicon carbide paper under running water . A vinyl tape punched with a 6 mm diameter hole was then placed on the dentin surface to demarcate the area for bonding . The thickness of the adhesive resin layer was varied by stacking an increasing numbers of vinyl tapes together . The teeth were r and omly divided into two groups and treated with either Clearfil Liner Bond 2V or Single Bond . They were further divided into subgroups according to the number of tapes placed on the dentin surface . After the bonding procedures the teeth were incrementally restored with Clearfil AP-X resin composite , building a 5 mm high crown to produce sufficient bulk for the microtensile bond test and stored in tap water at 37 degrees C for 24 hours . The teeth were then sectioned along their long axis into 0.7 mm thick slabs and trimmed for the microtensile bond test using a super-fine diamond bur . The thickness of the adhesive resin layer was then measured with a light microscope and the slabs tested in tension at a crosshead speed of 1 mm/minute . The results were subjected to statistical analysis by a one-way analysis of variance and linear regressions with 95 % confidence intervals . The thickness of the Clearfil Liner Bond 2V adhesive layer ranged from 5 mm-1500 mm , and for Single Bond , it varied from bond strengths increased significantly as the thickness of bonding layer increased ( p bond strengths of the Single Bond decreased significantly with increased thickness of the bonding layer ( p < 0.05 )",
"OBJECTIVE The purpose of this study was to evaluate the performance of a filled ( OptiBond Solo ) and an unfilled ( Prime & Bond 2.1 ) \" one-bottle \" adhesive in Class V restorations after 18 months of clinical service . METHODS Thirty-three patients with non-carious cervical lesions were enrolled in the study . A total of 101 lesions were restored using one of the adhesives and a hybrid composite resin . Enamel was not beveled , nor was any mechanical retention placed . The restorations were evaluated at baseline , and at 6 and 18 months after placement using modified USPHS criteria . RESULTS Cumulative 18-month retention rates were 93.6 % for OptiBond Solo and 98.0 % for Prime & Bond 2.1 . The difference in retention rates was not statistically significant . For OptiBond Solo , the only notable problems were interfacial staining and marginal adaptation , both of which were less than ideal in 9 % of restorations . Marginal problems were slightly less frequent for Prime & Bond 2.1 restorations , but the difference was not significant . CONCLUSIONS Both adhesives provided Class V retention rates exceeding the 18-month , full acceptance guidelines set by the American Dental Association . Any additional benefit provided by the use of a filled adhesive was not detected in this 18-month clinical trial",
"OBJECTIVES The goal of this study was to illustrate and define the micromorphological spectrum which exists at the resin-dentin interface when two water-free , acetone-based , single-bottle primer/adhesive systems ( One-Step , Bisco , and Prime & Bond , Dentsply/L.D. Caulk ) were applied to acid-conditioned dentin under different dry and wet bonding conditions . METHODS Forty-eight 1 mm dentin discs were each conditioned with 10 % phosphoric acid and rinsed for 20 s. They were r and omly divided into 4 groups based upon the status of the remaining surface moisture ; Group I ( 30 s dry ) ; Group II ( 3 s dry ) ; Group III ( blot dry ) and Group IV ( overwet ) . Bonded dentin disc pairs were then demineralized in EDTA and embedded in epoxy resin for transmission electron microscopic examination . RESULTS The micromorphological spectra of the two bonding systems were essentially similar . Both were effected by even mild desiccation ( 3 s ) , result ing in incomplete intertubular resin infiltration . Optimal intertubular resin infiltration was achieved when the collagen network was kept moist and appeared relatively unaffected by the presence of excess surface moisture . On the other h and , intratubular resin infiltration was severely compromised in the presence of excess water within the dentinal tubules and at their openings in the dentin surface . The continuity of the resin layer deteriorated ; blister-like spaces formed on the dentin surface and resin globules were found around the tubular orifices and on the surface of the hybrid layer . In addition , a complex phase separation pattern was observed in Prime & Bond that was characterized by phase inversion in the presence of surface moisture . SIGNIFICANCE The \" window of opportunity \" for optimal interfacial integrity for both water-free systems appeared to depend upon keeping the demineralized collagen network moist , coupled with the complete evaporation of excess and \" displaced \" water from tissues prior to light-curing the prime/adhesives"
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4117317e-06ff-11f0-808a-c43d1ab1c353
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HighlightsImpulsive aggression and dysfunctional response inhibition are present in ADHD and DBDs . Broad fronto‐striatal‐cerebellar dysfunctions have been implicated in ADHD and DBDs . Prefrontal and cingulate cortical deficits are associated with IA in ADHD.Severe widespread cortico‐subcortical breakdowns are associated with IA in DBDs . RI deficits have been attributed to hypoactivity in the lateral PFC , insula , and amygdala . Whether reduced gray matter volumes relate to ADHD and DBDs or if present as an IA epiphenomenon remains debatable . Background : Although impulsive aggression ( IA ) and dysfunctional response inhibition ( RI ) are hallmarks of attention‐deficit/hyperactivity disorder ( ADHD ) and disrupted behavioral disorders ( DBDs ) , little is known about their shared and distinct deviant neural mechanisms . Aims and Methods : Here , we selectively review ed s/fMRI ADHD and DBD studies to identify disorder‐specific and shared IA and RI aberrant neural mechanisms . Results : In ADHD , deviant prefrontal and cingulate functional activity was associated with increased IA . Structural alterations were most pronounced in the cingulate cortex . Subjects with DBDs showed marked cortico‐subcortical dysfunctions . ADHD and DBDs share similar cortico‐limbic structural and functional alterations . RI deficits in ADHD highlighted hypoactivity in the dorso/ventro‐lateral PFC , insula , and striatum , while the paralimbic system was primarily dysfunctional in DBDs . Across disorders , extensively altered cortico‐limbic dysfunctions underlie IA , while RI was mostly associated with aberrant prefrontal activity . Conclusion : Control network deficits were evidence d across clinical phenotypes in IA and RI . Dysfunctions at any level within these cortico‐subcortical projections lead to deficient cognitive‐affective control by ascribing emotional salience to otherwise irrelevant stimuli . The clinical implication s of these findings are discussed
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[
"OBJECTIVES Psychopathology has been reported to be prevalent both before and after surgical treatment for medically intractable temporal lobe epilepsy . Individual patients were evaluated prospect ively to assess the effect of anterior temporal lobectomy ( ATL ) on prevalence and severity of psychiatric disease . METHODS Psychiatric status was assessed in a consecutive series of epilepsy patients before and 6 months after ATL using a structured psychiatric interview , psychiatric rating scales , and self report mood measures . RESULTS A DSM-III-R axis I diagnosis was present in 65 % of patients before and after surgery . The most common diagnoses were depression , anxiety , and organic mood/personality disorders . There was a trend for major psychiatric diagnoses to be more common in patients with right compared to left temporal lobe seizure focus , both before and after surgery . The apparent stability in the overall rate of psychiatric dysfunction concealed onset of new psychiatric problems in 31 % of patients in the months shortly after surgery , and resolution of psychiatric diagnoses in 15 % of patients . In the group as a whole , the severity of psychiatric symptoms was lower at 6 months postsurgery than before temporal lobectomy . CONCLUSIONS The overall prevalence of psychiatric dysfunction was comparably high before and after ATL , but individual changes in psychiatric status and changes in severity of symptoms occurred in many patients in the 6 months after surgery",
"Aggressive behavior is a basic form of human social interaction , yet little is known about its neural substrates . We used a laboratory task to investigate the neural correlates of reactive aggression using functional magnetic resonance imaging . The task is disguised as a reaction-time competition between the subject and two opponents and entitles the winner to punish the loser . It seeks to elicit aggression by provocation of the subject . As each single trial in this task is separated into a decision phase , during which the severity of the prospect i ve punishment of the opponent is set , and an outcome phase , during which the actual punishment is applied or received , the paradigm enables us to analyze the neural events during each of these phases . Specific neural responses in areas related to negative affect , cognitive control and reward processing provide additional information about the cognitive , emotional and motivational processes underlying reactive aggressive behavior and afford us with the possibility to test and exp and theories on aggression such as the General Aggression Model",
"Although aggression research in general has been hampered by a lack of objective measurements of aggressive acts , two types of aggressive acts , impulsive vs. premeditated , have been studied extensively in recent years . These two types of aggression have been primarily measured by structured or semi-structured interviews . The current study was design ed to assess the construct validity of these two types of aggression using a self-report question naire which included items gleaned from the content of interviews used in past studies . For this study , 216 college students assessed their own aggressive acts rather than answering general questions about aggression . The students were not significantly different from normative sample groups on self-report measures of impulsiveness , aggression , and anger/hostility . A PCA factor analysis with a promax rotation of the items on the self-report question naire identified four factors : impulsive aggression ; mood on the day the act occurred ; premeditated aggression ; and agitation . Thus , impulsive and premeditated aggression are independent constructs which exist in varying degrees among these ' normal ' persons in a non- clinical sample . Impulsive aggression was characterized in part by feelings of remorse following the acts and by thought confusion . Premeditated aggression was related to social gain and dominance",
"This short-term longitudinal study ( N = 112 ) was conducted to explore the concurrent and prospect i ve associations between teacher-reported impulsive-hyperactive behavior and observed relational and physical aggression during early childhood ( M = 45.54 months old , SD = 9.07 ) . Multiple informants and methods including observational methods ( i.e. , 160 min per child ) were used to assess aggression and impulsivity-hyperactivity . All measures were found to be valid and reliable . Prospect i ve hierarchical regression analyses revealed that impulsivity-hyperactivity was associated with increases in observed physical aggression across time , controlling for initial relational aggression and gender . These findings add to the growing developmental psychopathology literature that suggests that distinguishing between subtypes of aggression during early childhood may be important for underst and ing the course of impulsivity-hyperactivity in young children . Implication s for practice are discussed",
"OBJECTIVE Youths with disruptive behavior disorders ( DBD ) ( conduct disorder and oppositional defiant disorder ) have an elevated risk for maladaptive reactive aggression . Theory suggests that this is due to an elevated sensitivity of basic threat circuitry implicated in retaliation ( amygdala/periaqueductal gray ) in youths with DBD and low levels of callous-unemotional traits and dysfunctional regulatory activity in the ventromedial prefrontal cortex in youths with DBD irrespective of callous-unemotional traits . METHOD A total of 56 youths 10 - 18 years of age ( 23 of them female ) participated in the study : 30 youths with DBD , divided by median split into groups with high and low levels of callous-unemotional traits , and 26 healthy youths . All participants completed an ultimatum game task during functional MRI . RESULTS Relative to the other groups , youths with DBD and low levels of callous-unemotional traits showed greater increases in activation of basic threat circuitry when punishing others and dysfunctional down-regulation of the ventromedial prefrontal cortex during retaliation . Relative to healthy youths , all youths with DBD showed reduced amygdala-ventromedial prefrontal cortex connectivity during high provocation . Ventromedial prefrontal cortex responsiveness and ventromedial prefrontal cortex-amygdala connectivity were related to patients ' retaliatory propensity ( behavioral responses during the task ) and parent-reported reactive aggression . CONCLUSIONS These data suggest differences in the underlying neurobiology of maladaptive reactive aggression in youths with DBD who have relatively low levels of callous-unemotional traits . Youths with DBD and low callous-unemotional traits alone showed significantly greater threat responses during retaliation relative to comparison subjects . These data also suggest that ventromedial prefrontal cortex-amygdala connectivity is critical for regulating retaliation/reactive aggression and , when dysfunctional , contributes to reactive aggression , independent of level of callous-unemotional traits",
"BACKGROUND Healthy individuals performing response suppression tasks activate anterior cingulate cortex with occurrence of false alarm error responses to nontargets . Fundamental questions include whether this error-related activation provides a signal contributing to behavioral control and , given generally poorer performance on such tasks by addicts , whether this signal is disrupted in addiction . METHODS We used rapid , event-related functional magnetic resonance imaging to study 13 individuals with opiate dependence and 26 healthy control individuals performing a Go/NoGo task . RESULTS Compared with controls , opiate addicts exhibited an attenuated anterior cingulate cortex error signal and significantly poorer task performance . In controls , the individual level of event-related anterior cingulate cortex activation accompanying false alarm error positively predicted task performance , particularly sensitivity in discriminating targets from nontargets . CONCLUSIONS The attenuation of this error signal in anterior cingulate cortex may play a role in loss of control in addiction and other forms of impulsive behavior",
"Youth with attention deficit hyperactivity disorder ( ADHD ) have deficits in interference inhibition , which can be improved with the indirect catecholamine agonist methylpheni date ( MPH ) . Functional magnetic resonance imaging was used to investigate the effects of a single dose of MPH on brain activation during interference inhibition in medication-naïve ADHD boys . Medication-naïve boys with ADHD were scanned twice , in a r and omized , double-blind design , under either a single clinical dose of MPH or placebo , while performing a Simon task that measures interference inhibition and controls for the oddball effect of low-frequency appearance of incongruent trials . Brain activation was compared within patients under either drug condition . To test for potential normalization effects of MPH , brain activation in ADHD patients under either drug condition was compared with that of healthy age-matched comparison boys . During incongruent trials compared with congruent – oddball trials , boys with ADHD under placebo relative to controls showed reduced brain activation in typical areas of interference inhibition , including right inferior prefrontal cortex , left striatum and thalamus , mid-cingulate/supplementary motor area , and left superior temporal lobe . MPH relative to placebo upregulated brain activation in right inferior prefrontal and premotor cortices . Under the MPH condition , patients relative to controls no longer showed the reduced activation in right inferior prefrontal and striato-thalamic regions . Effect size comparison , furthermore , showed that these normalization effects were significant . MPH significantly normalized the fronto-striatal underfunctioning in ADHD patients relative to controls during interference inhibition , but did not affect medial frontal or temporal dysfunction . MPH therefore appears to have a region-specific upregulation effect on fronto-striatal activation",
"A new methodology was employed to study the effects of drugs on human aggressive behavior in a laboratory situation . The effects of not smoking , smoking a low nicotine dose ( 0.42 mg/cigarette ) , and smoking a high nicotine dose ( 2.19 mg/cigarette ) on human nonaggressive and aggressive responding was determined . A nonaggressive response , which result ed in the accumulation of money , was continuously available to the subject . Two different aggressive responses were also available : the ostensible subtraction of money from , and the ostensible presentation of a 1-s blast of white noise to a ( fictitious ) person . Aggressive responding was elicited by subtracting money from the research subjects , which was attributed to a fictitious person paired with the research subject r and omly each day . Nicotine , administered with experimental cigarettes , produced dose-dependent decreases in both types of aggressive responding elicited by low or high frequency subtractions of money attributed to another person . Generally , the more aggressive response option , i.e. , subtraction of money from another person , decreased more following nicotine administration . Smoking the same doses of nicotine increased nonaggressive monetary reinforced responding . This indicates that the suppressant effect of nicotine on aggressive responding was not due to a nonspecific depressant action",
"Higher cognitive inhibitory and attention functions have been shown to develop throughout adolescence , presumably concurrent with anatomical brain maturational changes . The relatively scarce developmental functional imaging literature on cognitive control , however , has been inconsistent with respect to the neurofunctional substrates of this cognitive development , finding either increased or decreased executive prefrontal function in the progression from childhood to adulthood . Such inconsistencies may be due to small subject numbers or confounds from age-related performance differences in block design functional MRI ( fMRI ) . In this study , rapid , r and omized , mixed-trial event-related fMRI was used to investigate developmental differences of the neural networks mediating a range of motor and cognitive inhibition functions in a sizeable number of adolescents and adults . Functional brain activation was compared between adolescents and adults during three different executive tasks measuring selective motor response inhibition ( Go/no-go task ) , cognitive interference inhibition ( Simon task ) , and attentional set shifting ( Switch task ) . Adults compared with children showed increased brain activation in task-specific frontostriatal networks , including right orbital and mesial prefrontal cortex and cau date during the Go/no-go task , right mesial and inferior prefrontal cortex , parietal lobe , and putamen during the Switch task and left dorsolateral and inferior frontotemporoparietal regions and putamen during the Simon task . Whole-brain regression analyses with age across all subjects showed progressive age-related changes in similar and extended clusters of task-specific frontostriatal , frontotemporal , and frontoparietal networks . The findings suggest progressive maturation of task-specific frontostriatal and frontocortical networks for cognitive control functions in the transition from childhood to mid-adulthood"
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411731ba-06ff-11f0-808a-c43d1ab1c353
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HighlightsCognitive deficits are present in up to 70 % of people with multiple sclerosis (MS).There are no approved treatments for these difficulties . We examined whether adjunctive pharmacotherapies can improve cognition in MS.Acetylcholinesterase inhibitors offered no significant benefits over placebo . Stimulant‐based medications offered no significant benefits over placebo . & NA ; We sought to examine the effectiveness of acetylcholinesterase inhibitors ( AChEIs ) and stimulant‐based medications for improving cognitive performance in patients with multiple sclerosis ( MS ) . An electronic data base search was conducted on 25th March 2017 . Eligible studies were double‐blind , r and omised , placebo‐controlled trials that examined the efficacy of compounds that act primarily as AChEIs or stimulants ( administered daily for ≥1 week ) on cognitive outcome measures in patients with MS . Where suitable data was reported , we generated effect sizes and corresponding 95 % confidence intervals and performed meta‐analyses using r and om‐effects models to investigate the effectiveness of these drug types across cognitive domains . Sixteen trials were included in the systematic review , with eleven trials ( N = 734 MS patients ) providing sufficient data for meta‐ analysis . Whilst there was only a limited pool of relatively small trials and a number of different compounds , we found that collectively , both AChEIs ( donepezil and rivastigmine ) and stimulants ( methylpheni date , modafinil , l‐amphetamine sulfate and lisdexamfetamine dimesylate ) offered no significant benefits over placebo on measures of processing speed , working memory , verbal fluency , verbal memory , visuospatial memory or executive functioning
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[
"Objective : To assess the efficacy and safety of modafinil for the treatment of fatigue in multiple sclerosis ( MS ) . Methods : Patients aged 18–65 years with a diagnosis of MS , a stable disability level ≤6 on the Kurtzke extended disability status scale ( EDSS ) , and a mean score > 4 on the fatigue severity scale ( FSS ) were eligible for the 9 week , single blind , phase 2 , two centre study . Exclusion criteria included a diagnosis of narcolepsy , sleep apnoea , or clinical ly significant major systemic disease and recent use of medications affecting fatigue . All patients , who remained blinded for the treatment regimen , received placebo during weeks 1–2 , 200 mg/day modafinil during weeks 3–4 , 400 mg/day modafinil during weeks 5–6 , and placebo during weeks 7–9 . Safety was evaluated by unblinded investigators . Efficacy was evaluated by self rating scales , using the FSS , the modified fatigue impact scale ( MFIS ) , a visual analogue scale for fatigue ( VAS-F ) , and the Epworth sleepiness scale ( ESS ) . Adverse events were recorded . Results : Seventy two patients ( MS type : 74 % relapsing-remitting ; 7 % primary progressive ; 19 % secondary progressive ) received treatment . After treatment with 200 mg/day modafinil for 2 weeks , a significant improvement in fatigue versus placebo run in was demonstrated . Mean scores after treatment with 200 mg/day modafinil were : FSS , 4.7 versus 5.5 for placebo ( p ( p=0.003 ) . Fatigue scores for 400 mg/day modafinil were not significantly improved versus placebo run in . Mean ESS scores were significantly improved ( p ( 9.5 ) . Serious adverse events were not found at either dose . The most common adverse events were headache , nausea , and aesthenia . Sixty five patients ( 90 % ) completed the study . Conclusions : These data suggest that 200 mg/day modafinil significantly improves fatigue and is well tolerated in patients with MS",
"Abstract Rationale . Modafinil , a novel wake-promoting agent , has been shown to have a similar clinical profile to that of conventional stimulants such as methylpheni date . We were therefore interested in assessing whether modafinil , with its unique pharmacological mode of action , might offer similar potential as a cognitive enhancer , without the side effects commonly experienced with amphetamine-like drugs . Objectives . The main aim of this study was to evaluate the cognitive enhancing potential of this novel agent using a comprehensive battery of neuropsychological tests . Methods . Sixty healthy young adult male volunteers received either a single oral dose of placebo , or 100 mg or 200 mg modafinil prior to performing a variety of tasks design ed to test memory and attention . A r and omised double-blind , between-subjects design was used . Results . Modafinil significantly enhanced performance on tests of digit span , visual pattern recognition memory , spatial planning and stop-signal reaction time . These performance improvements were complemented by a slowing in latency on three tests : delayed matching to sample , a decision-making task and the spatial planning task . Subjects reported feeling more alert , attentive and energetic on drug . The effects were not clearly dose dependent , except for those seen with the stop-signal paradigm . In contrast to previous findings with methylpheni date , there were no significant effects of drug on spatial memory span , spatial working memory , rapid visual information processing or attentional set-shifting . Additionally , no effects on paired associates learning were identified . Conclusions . These data indicate that modafinil selectively improves neuropsychological task performance . This improvement may be attributable to an enhanced ability to inhibit pre-potent responses . This effect appears to reduce impulsive responding , suggesting that modafinil may be of benefit in the treatment of attention deficit hyperactivity disorder",
"Background : Cognitive decline has been recognised as a frequent symptom in multiple sclerosis ( MS ) . Cholinesterase inhibitors ( ChEIs ) are employed for the treatment of Alzheimer ’s disease , but there is some evidence that ChEIs might also be effective in MS patients with cognitive deficits , particularly deficits of memory function . Objective : The aim of this study was to evaluate efficacy on memory function and safety of the ChEI rivastigmine in MS patients with cognitive deficits as measured by the change from baseline of the total recall score of the selective reminding test ( SRT ) after 16 weeks of treatment . Methods : Efficacy and safety of rivastigmine were analysed in a 16-week , multicentre , double-blind , r and omised , placebo-controlled study , followed by an optional one-year open-label treatment phase . Effects of rivastigmine and placebo were compared by an analysis of covariance . Results : In total , 86 patients were enrolled . Patients who received rivastigmine ( n = 43 ) showed a non-significant increase in total recall score ( sum of all words immediately recalled over all six trials ) over placebo ( n = 38 ) after 16 weeks of treatment ( p = 0.2576 ) . Other outcome measures provided no evidence supporting benefits of rivastigmine . Treatment with rivastigmine was well tolerated . Conclusions : With the results of this study , the need for an effective therapy in cognitively impaired MS patients is still required . Thus , intensive and continued clinical research is required to explore therapeutic options for cognitive deficits in MS patients",
"Objective : To assess whether modafinil , a wakefulness-promoting agent , is useful for fatigue in patients with multiple sclerosis ( MS ) . Methods : Patients with MS with stable disability , and a baseline score of 45 or more on the Modified Fatigue Impact Scale ( MFIS ) , were eligible for the 5-week r and omized , double-blind , placebo-controlled , parallel group study . The initial daily dose of modafinil was 200 mg for 1 week . Depending on tolerance , the dose was increased by 100 mg every week up to 400 mg/day and remained unchanged between day 21 and day 35 . The primary outcome variable was the change of MFIS score at day 35 . Results : A total of 115 patients with MS were enrolled in the study and in the intention to treat analysis . The mean MFIS score at baseline was 63 ± 9 in the placebo group and 63 ± 10 in the modafinil group . MFIS scores improved between day 0 and day 35 in both placebo-treated and modafinil-treated groups , but no significant difference was detected between the two groups . There was no major safety concern . Conclusions : There was no improvement of fatigue in patients with multiple sclerosis treated with modafinil vs placebo according to the Modified Fatigue Impact Scale",
"PURPOSE / OBJECTIVE To assess the efficacy of modafinil for the treatment of new learning and memory deficits and fatigue in multiple sclerosis . Only 1 previous study in the literature , to our knowledge , examined the effect of modafinil on cognition specifically in persons with multiple sclerosis . RESEARCH METHOD / DESIGN Sixteen patients with a diagnosis of multiple sclerosis ( MS ) and documented new learning impairment completed the study . In a 5-week r and omized , double-blinded , crossover design , participants received either a single daily oral dose of modafinil ( 200 mg ) or placebo for 2 weeks . A 1-week washout period was included between study arms . RESULTS No effect of modafinil was noted on learning and memory performance . Participants taking 200 mg of modafinil showed improvement in 1 of the 2 working memory measures administered , the Wechsler Adult Intelligence Scale-III ( WAIS-III ) Letter-Number Sequencing task , as compared with those on placebo . Treatment with modafinil did not have a beneficial effect in reducing self-reported fatigue . No changes were noted on the Modified Fatigue Impact Scale or the Fatigue Severity Scale with the treatment of modafinil , as compared with placebo . CONCLUSIONS / IMPLICATION S Findings indicate that 200 mg of modafinil has the potential to improve working memory in persons with MS . These findings suggest that modafinil may enhance aspects of cognition in persons with MS and may be an effective adjunct to clinical rehabilitation interventions",
"Objectives : The goal of this study was to determine if memory would be improved by donepezil as compared to placebo in a multicenter , double-blind , r and omized clinical trial ( RCT ) . Methods : Donepezil 10 mg daily was compared to placebo to treat memory impairment . Eligibility criteria included the following : age 18–59 years , clinical ly definite multiple sclerosis ( MS ) , and performance ≤½ SD below published norms on the Rey Auditory Verbal Learning Test ( RAVLT ) . Neuropsychological assessment s were performed at baseline and 24 weeks . Primary outcomes were change on the Selective Reminding Test ( SRT ) of verbal memory and the participant 's impression of memory change . Secondary outcomes included changes on other neuropsychological tests and the evaluating clinician 's impression of memory change . Results : A total of 120 participants were enrolled and r and omized to either donepezil or placebo . No significant treatment effects were found between groups on either primary outcome of memory or any secondary cognitive outcomes . A trend was noted for the clinician 's impression of memory change in favor of donepezil ( 37.7 % ) vs placebo ( 23.7 % ) ( p = 0.097 ) . No serious or unanticipated adverse events attributed to study medication developed . Conclusions : Donepezil did not improve memory as compared to placebo on either of the primary outcomes in this study . Classification of evidence : This study provides Class I evidence which does not support the hypothesis that 10 mg of donepezil daily for 24 weeks is superior to placebo in improving cognition as measured by the SRT in people with MS whose baseline RAVLT score was 0.5 SD or more below average",
"Introduction Cognitive impairment is common and debilitating among persons with multiple sclerosis ( MS ) and might be managed with exercise training . However , the effects of exercise training on viscoelastic brain properties in this population are unknown . The present pilot study adopted a single-blind r and omized controlled trial ( RCT ) design and is the first to examine the effect of an aerobic exercise training intervention on learning and memory and hippocampal viscoelasticity using magnetic resonance elastography ( MRE ) in persons with MS . Methods Eight fully ambulatory females with MS were r and omly assigned into exercise training intervention or waitlist control conditions . The intervention condition involved 12 weeks of supervised , progressive treadmill walking exercise training . All participants underwent measures of learning and memory ( i.e. , California Verbal Learning Test-II ; CVLT-II ) and further underwent MRE scans for measurement of shear stiffness ( μ ) and damping ratio ( ξ ) of the hippocampus before and after the 12-week period . Results Overall , there were small-to-moderate intervention effects on CVLT-II performance ( d = 0.34 ) and large intervention effects on hippocampal μ ( d = 0.94 ) and hippocampal ξ ( d = −1.20 ) . Change in CVLT-II scores was strongly associated with change in μ ( r = 0.93 , p supporting progressive treadmill walking exercise training for potentially improving learning and memory and underlying hippocampal viscoelastic properties in persons with MS . This is important given the high prevalence and burden of MS-related memory impairment",
"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",
"Rationale Multiple sclerosis ( MS ) commonly affects cognitive function , most frequently presenting as impaired processing speed ( PS ) . There are currently no approved treatments for PS in this population , but previous studies suggest amphetamines may be beneficial . Objective The objective of this study is to determine if mixed amphetamine salts , extended release ( MAS-XR ) has the potential to improve impaired PS in MS patients in a r and omized controlled pre- and post-dose testing study . Methods Fifty-two MS patients demonstrating PS impairment on either the Symbol Digit Modalities Test ( SDMT ) or Paced Auditory Serial Addition Test ( PASAT ) were r and omized to a single dose of 5 mg MAS-XR ( n = 18 ) , 10 mg MAS-XR ( n = 20 ) , or placebo ( n = 14 ) . Subjects were evaluated a second time , after taking the blinded medication . ANOVA was used to compare the change on the SDMT and PASAT in each of the treatment groups compared to the placebo . Cohen ’s d was used to calculate effect size . Results At baseline , the mean SDMT score was 43.3 ± 7.2 and the mean PASAT was 34.8 ± 13.4 , with 47 ( 90.4 % ) and 25 ( 48.1 % ) categorized as impaired on the SDMT and PASAT , respectively . The change in SDMT scores from baseline to post-treatment demonstrated significant improvement for the MAS-XR 10-mg dose compared to placebo , increasing by 5.2 ± 4.5 vs. 0.6 ± 4.4 points ( p = 0.043 ) , with a medium effect size of 0.47 . Change on the PASAT was not significantly different in either treatment group . Conclusions This study supports MAS-XR 10 mg as a potential treatment for MS patients with demonstrated PS impairment , warranting a larger longitudinal study",
"Background : Cognitive dysfunction is very common in multiple sclerosis ( MS ) and it severely impairs patients ’ quality of life . Thus , we explored whether memantine might improve cognitive performance in patients with MS . Methods : We conducted a pilot trial with memantine ( 30 mg/day ) in patients with MS with cognitive impairment . The trial was design ed as a 1-year , r and omized , double-blind , crossover study comparing memantine against a placebo in 60 patients with MS and cognitive impairment . Cognitive impairment was defined as the performance 1.5 st and ard deviations below the normative data in at least two tests of two cognitive domains in the Brief Repeatable Battery – Neuropsychology . The primary endpoint was improvement of verbal memory and the secondary endpoints were safety and improvements in the other cognitive domains , disability and quality of life . The trial was registered at www . clinical trials.org : NCT00638833 . Results : Although 19 patients had been included , the trial was halted after nine patients reported a worsening of their neurologic symptoms that deteriorated their quality of life . Seven of the nine patients in the memantine arm had blurred vision , fatigue , severe headache , increased muscle weakness , walking difficulties , or unstable gait . Only two patients in the placebo group reported neurologic symptoms and in both cases they were related with changes in their disease-modifying therapy . The adverse events only occurred on reaching the maximum dose ( 30 mg/day ) . After stopping medication , the patients reverted to their baseline disability within a few days . Conclusions : Memantine at a dose of 30 mg/day may induce transient worsening of neurologic symptoms of multiple sclerosis",
"Defects in processing speed and memory are common in multiple sclerosis ( MS ) patients . In other population s , amphetamines have been shown to enhance cognition , but their use is limited by adverse behavioral effects . The l-isomer may have equivalent cognition enhancement with less adverse effects due to decreased potency in subcortical areas . The aim of this study was to assess the safety and efficacy of l-amphetamine sulfate in the treatment of cognitive dysfunction in MS . This was a 2:1 r and omized , placebo-controlled , double-blind trial , involving 33 MS clinics across the USA . One hundred and fifty-one clinical ly definite MS patients with documented cognitive dysfunction who were relapse free for ≥90 days , with an Exp and ed Disability Status Scale ( EDSS ) ≤6.5 , and with no other medical/psychiatric condition that may cause psychological dysfunction were r and omized to 30 mg of oral l-amphetamine sulfate or placebo for 29 days , including a dose escalation period . A history of cardiac disease , uncontrolled hypertension or electrocardiograph abnormalities result ed in exclusion . The primary outcomes were the Subject Global Assessment of Change and Symbol Digit Modalities Test ( SDMT ) . Secondary outcomes were the results from the California Verbal Learning Test , second edition ( CVLT2 ) , Brief Visual Memory Test-Revised ( BVMTR ) , and Paced Auditory Serial Addition Test ( PASAT ) . One hundred and thirty-six subjects completed the study . No differences were found at baseline in demographics or in the results of the neuropsychological tests . After treatment , the active group performed significantly better for total learning ( P = 0.041 ) and delayed recall ( P for delayed recall ( P = 0.012 ) on the CVLT2 . Five patients ( four from the treatment group , one placebo ) withdrew due to intolerable adverse events . l-amphetamine sulfate was associated with improved learning and memory and was well tolerated in this study . However , because the positive findings were observed on secondary outcome measures , the study requires replication before l-amphetamine sulfate can be recommended for the treatment of cognitive impairment in MS",
"Background To investigate the effects of Modafinil on focused attention , motor function and motor excitability in patients with multiple sclerosis ( MS ) and fatigue . Methods 21 MS patients with fatigue were enrolled in this double-blind placebo-controlled study . Modafinil ( MOD ) or placebo ( PL ) was administered for 8 weeks . The d2 alertness test , the Nine Hole Peg Test ( 9HPT ) and several transcranial magnetic stimulation ( TMS ) techniques were applied prior to and after the first drug ingestion and well as after 8 weeks of drug intake . Results Prior to the first drug intake , the two groups were comparable . After the first drug ingestion , fatigue as measured by the Fatigue Severity Scale ( FSS ) , performance of the d2 test and the 9HPT improved significantly in the MOD group and remained better than in the PL group after 8 weeks of treatment . Patients in the MOD group made fewer mistakes in the D2 test without being slower . They completed the 9HPT faster . Motor evoked potential amplitudes produced by paired pulse TMS were larger in the MOD group than the PL group . Motor thresholds and silent period duration s remained unchanged . Conclusions Compared to PL , MOD improved fatigue , focused attention and dexterity and enhanced motor cortex excitability in this group of patients . MOD may be helpful in MS patients with fatigue to improve cognitive and motor abilities",
"To examine the efficacy and toxicity of oral 3,4 diaminopyridine ( DAP ) in dosages up to 100 mg/day , 36 patients with multiple sclerosis ( MS ) enrolled in a r and omized , double-blind , placebo-controlled , crossover trial . The primary outcome measure was improvement of a prospect ively defined neurologic deficit , which was leg weakness in 34 patients . Secondary outcome measures included the patient 's subjective response , scored manual motor testing ( MMT ) of leg strength , scored leg strength from videotaped motor testing ( VMT ) , quadriceps and hamstrings strength ( QMT ) measured by isometric dynamometry , neuropsychological testing ( NPT ) , ambulation index ( AI ) , and Exp and ed Disability Status Scale ( EDSS ) score . Paresthesias and abdominal pain were common and were dose limiting in eight patients . Three patients had episodes of confusion , and one patient had a seizure while on DAP . Eight patients withdrew from the study , leaving 28 evaluable patients for the efficacy analysis . The prospect ively defined neurologic deficit improved in 24 patients -22 on DAP and 2 on placebo ( p = 0.0005 ) . All improvements were in leg weakness . Subjective response and measures of leg strength and function ( MMT , VMT , QMT , and AI ) improved on DAP compared with placebo . Neither NPT nor EDSS scores improved . DAP treatment can induce improvements in leg strength in MS patients , but toxicity is limiting in many patients . NEUROLOGY 1996;47 : 1457 -",
"Background : Memory impairment is prevalent in multiple sclerosis ( MS ) , but no drugs are approved to treat these memory problems . Objective : The objective of the study was to examine the effect of l-amphetamine versus placebo on auditory/verbal memory and visual/spatial memory in MS patients with and without baseline memory impairment . Methods : We conducted a re- analysis of a previously published clinical trial in which MS patients were r and omly assigned to treatment ( 30 mg l-amphetamine , N = 99 ) or placebo ( N = 37 ) in a four-week , double-blind , parallel-group , dose titration trial . Auditory/verbal memory ( CVLT-II : Long Delay Free Recall ) and visual/spatial memory ( BVMT-R : Delayed Recall ) were assessed at baseline and follow-up across subgroups of patients with intact baseline memory ( mean = 50th percentile ) or impaired baseline memory ( mean = 2nd percentile ) . Primary analyses : 2 ( l-amphetamine , placebo ) × 2 ( baseline , follow-up ) , × 2 ( baseline memory intact , baseline memory impaired ) ANOVAs performed separately for auditory/verbal and visual/spatial memory . Results : For both auditory/verbal and visual/spatial memory , we observed significant 2 × 2 × 2 interactions whereby l-amphetamine improved memory more than placebo , and this effect was specific to patients with baseline memory impairment . Conclusions : Among memory-impaired patients , memory improved about 48.5 % for those on l-amphetamine , but only 1.0 % on placebo . Treatment with l-amphetamine produced large memory gains among memory-impaired MS patients",
"Objectives To determine if Ginkgo biloba ( GB ) improves the cognitive performance of subjects with multiple sclerosis ( MS ) . Methods R and omized , double-blind , placebo-controlled trial of GB , 120 mg twice a day or placebo for 12 weeks . The primary outcomes were : the long delay free recall from the California Verbal Learning Test-II ; the Paced Auditory Serial Addition Test ; the Controlled Oral Word Association Test ; the Symbol Digit Modalities Test ; Useful Field of View Test ; and the color-word interference condition from the Stroop Color and Word Test . Results On completion , the GB group ( n=20 ) was 4.5 seconds ( 95 % confidence interval ( CI ) ( 7.6 , 0.9 ) , P=0.015 ) faster than the placebo group ( n=18 ) on the color-word interference condition of the Stroop test . Subjects who were more impaired at baseline experienced more improvement with GB ( treatment*baseline interaction , F=8.10 , P=0.008 ) . We found no differences on the other neuropsychological tests . Subjects on GB reported fewer cognitive difficulties in the Retrospective Memory Scale of the Perceived Deficits Question naire than subjects on placebo ( 1.5 points , 95 % CI ( 2.6 , 0.3 ) , P=0.016 ) . No serious drug related side-effects occurred and GB did not alter platelet function assays . Conclusion Overall , GB did not show a statistically significant improvement in cognitive function . A treatment effect trend , limited to the Stroop test , suggests that GB may have an effect on cognitive domains assessed by this test , such as susceptibility to interference and mental flexibility . Multiple Sclerosis 2007 ; 13 : 376 - 385 .",
"Multiple sclerosis ( MS ) causes cognitive impairment including slowed processing speed and problems with learning and memory . Stimulants are attractive c and i date s for improving mental speed but carry risk of addiction and other adverse behavioral effects . Lisdexamfetamine dimesylate ( LDX ) is a d-amphetamine prodrug currently approved for attention deficit ( hyperactivity ) disorder with the potential to be better tolerated due to its prolonged clinical effect . This phase II placebo-controlled , double-blind study aim ed to assess the safety and efficacy of LDX in cognitively impaired MS patients . Subjects were patients with clinical ly definite MS , aged 18–56 years , and impaired on either of two primary outcomes : the Symbol Digit Modalities Test ( SDMT ) or the Paced Auditory Serial Addition Test ( PASAT ) . Both SDMT and PASAT are measures of cognitive processing speed . Of 174 MS patients screened , 63 were r and omized to 30 mg of LDX or placebo in a 2:1 fashion ; the dose was increased as tolerated to 70 mg over 4 weeks and then maintained for another 4 weeks . Secondary outcomes were the Brief Visuospatial Memory Test Revised ( BVMTR ) , the California Verbal Learning Test 2nd edition ( CVLT2 ) , both measures of episodic memory , and the Behavioral Rating Inventory of Executive Function for adults ( BRIEF-A ) , a self-report measure of executive function . Fatigue and depression were also evaluated . There was significant improvement in the SDMT score ( + 4.6 vs. + 1.3 ) and CVLT2 score ( + 4.7 vs. −0.9 ) in the LDX group compared with the placebo group among the 49 completers . There was no change on the other outcomes . A high proportion of both LDX-treated and placebo-treated subjects reported adverse events ( 73.5 % vs. 68.4 % ) . However , there were no serious adverse events noted in the study . These preliminary data indicate that LDX has the potential to be an efficacious treatment for MS patients with cognitive impairment",
"We investigated the effect of amantadine on cognitive processing in patients with multiple sclerosis ( MS ) and fatigue with objective electrophysiological measures . Behavioral methods ( Reaction Time , RT ) and two different Event Related Potential ( ERP ) components measuring i ) stimulus selection ( Selection Negativity , SN ) and ii ) response selection ( Lateralized Readiness Potential , LRP ) were employed . Twenty-four patients with clinical definite MS ( 10 relapsing remitting and 14 secondary progressive ) and confirmed fatigue in the past three months ( Fatigue Severity Scale ( FSS ) > 4 ) were included . Patients were r and omized in a double-blind , placebo-controlled cross-over design . We found a difference between the two treatments for ERP measures to stimuli with relevant colour starting at about 200 ms . This negativity had a higher amplitude during amantadine treatment regardless of treatment order . The RT did not differ significantly between the treated and untreated groups . Additional analysis indicated that patients with a disease duration of less than 7 years had a significant test position ( practice effect ) , but no treatment effect , while patients with a longer MS duration showed no practice effect , but rather an improved reaction speed and increased ERP amplitude effects when treated with amantadine . The present findings suggest that amantadine exerts beneficial effects on early cognitive processes in patients with MS , but appears to be limited to subjects with a longer duration of the disease",
"BACKGROUND Amantadine hydrochloride and pemoline , both frequently used to treat the fatigue of multiple sclerosis ( MS ) , may also improve attention and other cognitive functions in MS . To our knowledge , these agents have never been compared in a placebo-controlled trial of patients with MS . OBJECTIVE To evaluate the effects of amantadine and pemoline on cognitive functioning in MS . METHODS A total of 45 ambulatory patients with MS and severe fatigue were treated for 6 weeks with amantadine , pemoline , or placebo using a parallel group design . They underwent comprehensive neuropsychological testing to determine treatment effects on cognitive functioning . Primary outcome measures were tests of attention ( Digit Span , Trail Making Test , and Symbol Digit Modalities Test ) , verbal memory ( Selective Reminding Test ) , nonverbal memory ( Benton Visual Retention Test ) , and motor speed ( Finger Tapping Test ) . RESULTS Fatigue did not significantly correlate with any of the neuropsychological outcome measures at baseline or after treatment . All three treatment groups improved on tests of attention ( P verbal memory ( P motor speed ( P amantadine nor pemoline enhances cognitive performance in MS compared with placebo",
"Background : Exercise may have beneficial effects on both well-being and walking ability in multiple sclerosis ( MS ) . Exercise is shown to be neuroprotective in rodents and may also enhance cognitive function in humans . It may , therefore , be particularly useful for MS patients with pronounced neurodegeneration . Objective : To investigate the potential of st and ardized exercise as a therapeutic intervention for progressive MS , in a r and omized-controlled pilot trial . Methods : Patients with progressive MS and moderate disability ( Exp and ed Disability Status Scale ( EDSS ) of 4–6 ) were r and omized to one of three exercise interventions ( arm ergometry , rowing , bicycle ergometry ) for 8–10 weeks or a waitlist control group . We analyzed the drop-out rate as a measure of feasibility . The primary endpoint of the study was aerobic fitness . Secondary endpoints were walking ability , cognitive function as measured by a neuropsychological test battery , depression and fatigue . Results : A total of 42 patients completed the trial ( 10.6 % drop-out rate ) . Significant improvements were seen in aerobic fitness . In addition , exercise improved walking ability , depressive symptoms , fatigue and several domains of cognitive function . Conclusion : This study indicated that aerobic training is feasible and could be beneficial for patients with progressive MS . Larger exercise studies are needed to confirm the effect on cognition . Trial Registration : IS RCT N ( trial number 76467492 ) http://is rct",
"BACKGROUND Cognitive dysfunction is one of the common clinical symptoms in multiple sclerosis ( MS ) , but there is no effective treatment for it . OBJECTIVE The aim of this study was to evaluate the effect of rivastigmine in treating memory and cognitive dysfunction in MS . METHODS A single-center double-blind placebo-controlled r and omized clinical trial conducted from October 2005 to February 2007 . Sixty definite MS patients with cognitive impairment age 16 to 54 years were r and omly allocated to receive a 12-week treatment course of either rivastigmine ( 1.5 mg once a day increment over 4 weeks to 3 mg twice daily ) or placebo . Response to treatment was assessed by the Wechsler Memory Scale ( WMS ) at baseline and 12 weeks after start of therapy . RESULTS A slight , but significant memory improvement occurred in both groups . Of the 30 patients treated with rivastigmine , the mean ( SD ) WMS general memory score increased from 60.3 ( 4.2 ) at baseline to 64.9 ( 5.3 ) at the end of study period ( P mean ( SD ) WMS general memory score increased from 60.5 ( 4.9 ) to 64.5 ( 3.7 ) ( P average WMS general memory score at the end of trial did not changed between rivastigmine and placebo group ( mean difference , 0.4 ; 95 % CI , -2.0 , 2.8 ) . CONCLUSION No significant differences were seen between rivastigmine and placebo on the mean ( SD ) WMS general memory score . A larger multicenter study of rivastigmine in MS is warranted in order to more definitely assess the efficacy of this intervention",
"Background : Memantine , an NMDA antagonist , is effective for moderate to severe Alzheimer ’s disease . Objective : Determine whether memantine improves cognitive performance ( CP ) among subjects with multiple sclerosis ( MS ) and cognitive impairment ( CI ) . Methods : This double-blind , r and omized , placebo-controlled trial ( Clinical trials.gov NCT00300716 ) compared memantine 10 mg twice a day ( 4 week titration followed by 12 weeks on the highest tolerated dose ) with placebo . The primary outcome was the change from baseline to exit on the Paced Auditory Serial Addition Test ( PASAT ) and the California Verbal Learning Test-II ( CVLT-II ) Long Delay Free Recall ( LDFR ) . Secondary outcomes included additional neuropsychological tests ; self-report measures of quality of life , fatigue , and depression ; and family/caregiver reports of subjects ’ CI and neuropsychiatric symptoms . Results : The differences between the groups on the change on the PASAT ( placebo — memantine = 0.0 correct responses , 95 % CI 3.4 , 3.4 ; p = 0.9 ) and on CVLT-II LDFR ( placebo — memantine = —0.6 words , 95 % CI —2.1 , 0.8 ; p = 0.4 ) as well as on the other cognitive tests were not significant . Subjects on memantine had no serious adverse events ( AEs ) but had more fatigue and neurological AEs as well as , per family members ’ reports , less cognitive improvement and greater neuropsychiatric symptoms than subjects on placebo . Conclusion : Memantine 10 mg twice a day does not improve CP in subjects with MS , ages 18—65 , without major depression , who have subjective cognitive complaints and perform worse than one SD below the mean on the PASAT or on the California Verbal Learning Test-II ( total recall or delayed free recall )",
"Objective : Examine the efficacy of armodafinil in improving cognition in patients with multiple sclerosis ( MS ) . Background : Many patients with MS experience cognitive difficulties . Armodafinil has shown promise as a cognitive enhancer in other patient population s. No studies have examined whether armodafinil improves cognition in patients with MS . Methods : We conducted a double-blind , placebo-controlled , crossover study testing the efficacy of armodafinil in reducing cognitive problems in patients with MS . We r and omized 17 patients to receive a dose of lactose placebo about 2 hours before they underwent a neuropsychological testing session . After a week-long washout period , we gave them a single 250-mg dose of armodafinil about 2 hours before testing them a second time . We r and omized another 16 patients to receive the active drug first , then the placebo . We excluded 3 of the participants before analyzing the data . Results : After correcting for multiple comparisons of the 8 neuropsychological dependent measures , we found that the patients had significantly improved delayed memory on a list-learning task after they took armodafinil ( P=0.0005 ) , but no improvement on measures of executive function , visual memory , processing speed , or self-reported fatigue . Conclusions : Results provide preliminary evidence that armodafinil may improve delayed verbal recall in patients with MS . A larger trial showing enhanced memory among patients taking long-term armodafinil could serve as a foundation for its possible clinical use as a memory enhancer in patients with MS",
"Previous studies suggest that aminopyridine may play a role in the symptomatic treatment of fatigue in multiple sclerosis . Although the mechanism underlying the beneficial effect on fatigue remains unclear , it has been proposed that aminopyridines may help to improve conduction in demyelinated central pathways , implicating both axonal and synaptic mechanisms . The objective of the present study is to determine whether 4-AP decreases daily-living fatigue in progressive multiple sclerosis . The effect of 4-AP on other neurophysiological and neuropsychological parameters was also considered . A ` double-blind ' , r and omized , ` placebo-controlled ' , crossover trial was conducted on 54 patients with progressive multiple sclerosis . All patients received treatment with placebo and 32 mg per day of 4-AP , each for 6 months . The main outcome measure was the Fatigue Severity Scale . Secondary measures were EDSS , cognitive functions and neurophysiological parameters . Forty-nine patients ( 91 % ) completed the study . Changes in fatigue scores , EDSS and cognitive functions were not significantly different between 4-AP and placebo . However , when patients treated with 4-AP were divided into two groups according to the serum level of 4-AP , a significant effect on fatigue compared with placebo was observed in the ` high level ' ( 430 ng/ml ) group ( P=0.05 ) . Synchronization of motor evoked potentials improved during 4-AP with respect to placebo ( P=0.019 ) and this correlated positively with fatigue reduction ( P=0.010 ) . No relevant side effects were observed",
"4 Aminopyridine ( 4-AP ) has a favorable effect on the disability of certain patients with MS . We investigated the effect of 4-AP on neuropsychological performance in 20 MS patients using a r and omized , double-blind , placebo-controlled , crossover design . Although there was a trend for improved performance with 4-AP for two of the tests , we could not demonstrate significant effects of 4-AP on cognitive function",
"Objective : To reassess the effect of modafinil , a wakefulness-promoting artificial psychostimulant , on fatigue and neuropsychological measures in patients with multiple sclerosis . Methods : Multiple sclerosis ( MS ) patients with a baseline score of ≥4 on the Fatigue Severity Scale ( FSS ) and an Exp and ed Disability Status Scale score were eligible for the 8-week r and omized , double-blind , placebo-controlled study . Modafinil was dosed up to 200 mg/day within 1 week . Assessment s were performed at baseline and after 4 and 8 weeks . The primary outcome parameter was the mean change of the FSS mean score . Secondary outcome variables were other question naires covering fatigue , daytime sleepiness and sleep quality . Cognitive impairment was assessed by the oral version of the Symbol Digit Modalities Test ( SDMT ) and the Paced Auditory Serial Addition Test ( PASAT ) . Results : The study included 121 MS patients . Dropout rate was 9 % . Both treatment groups showed improvements through time . While mean FSS at 8 weeks showed a trend difference between groups in the intention-to-treat analysis , the primary endpoint was not met . Assessment of cognitive impairment by SDMT and PASAT showed contradictory results . All other secondary endpoints were not met . There was no major safety concern . Conclusions : In general , the study does not support modafinil as an effective treatment for MS fatigue . However , the study shows the need for new study design s and endpoints in MS fatigue studies",
"Background : Cognitive decline and fatigue are typical in multiple sclerosis ( MS ) . However , there is no official medication for either of these symptoms . Objective : The purpose of this study was to estimate the effects of a single dose of rivastigmine on processing speed and associated brain activity in patients with MS and subjective cognitive fatigue . Methods : Fifteen patients with MS and subjective cognitive fatigue and 13 healthy controls ( HCs ) matched for age , gender and education performed a neuropsychological assessment and functional (f)MRI . A modified version of the Paced Visual Serial Addition Test ( mPVSAT ) was used as the behavioural task during fMRIs . After the first scanning session , both groups were r and omly divided into two subgroups receiving either rivastigmine or placebo . A single dose of rivastigmine or placebo was administrated double-blindly and 2.5 hours later the scanning was repeated . Results : At baseline , the patients with MS showed slower processing speed in mPVSAT compared with the HCs . They also demonstrated stronger bilateral frontal activation after sustained cognitive effort than the HCs . Performance improvement and a further activation increase in the left anterior frontal cortex and additional activation in the right cerebellum were observed in patients who received rivastigmine but not in patients on placebo , or in HCs with placebo or rivastigmine . Conclusion : These preliminary findings suggest that rivastigmine may improve cognitive processing speed by enhancing compensatory brain activation in patients with MS",
"Objective : To determine whether Ginkgo biloba extract ( ginkgo ) improves cognitive function in persons with multiple sclerosis ( MS ) . Methods : Persons with MS from the Seattle and Portl and VA clinics and adjacent communities who scored 1 SD or more below the mean on one of 4 neuropsychological tests ( Stroop Test , California Verbal Learning Test II [ CVLT-II ] , Controlled Oral Word Association Test [ COWAT ] , and Paced Auditory Serial Addition Task [ PASAT ] ) were r and omly assigned to receive either one 120-mg tablet of ginkgo ( EGb-761 ; Willmar Schwabe GmbH & Co , Germany ) or one placebo tablet twice a day for 12 weeks . As the primary outcome , we compared the performance of the 2 groups on the 4 tests at exit after adjusting for baseline performance . Results : Fifty-nine subjects received placebo and 61 received ginkgo ; 1 participant receiving placebo and 3 receiving ginkgo were lost to follow-up . Two serious adverse events ( AEs ) ( myocardial infa rct ion and severe depression ) believed to be unrelated to the treatment occurred in the ginkgo group ; otherwise , there were no significant differences in AEs . The differences ( ginkgo − placebo ) at exit in the z scores for the cognitive tests were as follows : PASAT −0.2 ( 95 % confidence interval [ CI ] −0.5 to 0.1 ) ; Stroop Test −0.5 ( 95 % CI −0.9 to −0.1 ) ; COWAT 0.0 ( 95 % CI −0.2 to 0.3 ) ; and CVLT-II 0.0 ( 95 % CI −0.3 to 0.3 ) ; none was statistically significant . Conclusions : Treatment with ginkgo 120 mg twice a day did not improve cognitive performance in persons with MS . Classification of evidence : This study provides Class I evidence that treatment with ginkgo 120 mg twice a day for 12 weeks does not improve cognitive performance in people with MS"
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BACKGROUND Type 2 diabetes is a common and costly chronic disease which is associated with significant premature mortality and morbidity . Although patient education is an integral component of diabetes care , there remain uncertainties regarding the effectiveness of different methods and modes of education . OBJECTIVES To evaluate the effectiveness of individual patient education on metabolic control , diabetes knowledge and psychosocial outcomes . SEARCH STRATEGY Multiple electronic bibliographic data bases were search ed , including The Cochrane Library , MEDLINE , Pre medline , ERIC , Biosis , AMED , Psychinfo , EMBASE , CINAHL , APAIS-health , Australian Medical Index , Web of Science , dissertation abstract s and Biomed Central . SELECTION CRITERIA R and omized controlled and controlled clinical trials which evaluated individual education for adults with type 2 diabetes . The intervention was individual face-to-face patient education while control individuals received usual care , routine treatment or group education . Only studies that assessed outcome measures at least six months from baseline were included . DATA COLLECTION AND ANALYSIS Information was extracted by two review ers who summarized both study characteristics and outcome statistics . A meta- analysis using a fixed-effect model was performed if there were adequate studies with a specified outcome of sufficient homogeneity . For outcomes where there were too few studies or the assessment measurements were not st and ardized or variable , the results were summarised qualitatively . MAIN RESULTS Nine studies involving 1359 participants met the inclusion criteria . Six studies compared individual education to usual care and three compared individual education to group education ( 361 participants ) . There were no long-term studies and overall the quality of the studies was not high . In the six studies comparing individual face-to-face education to usual care , individual education did not significantly improve glycaemic control ( weighted mean difference ( WMD ) in HbA1c -0.1 % ( 95 % confidence interval ( CI ) -0.3 to 0.1 , P = 0.33 ) over a 12 to 18 month period . However , there did appear to be a significant benefit of individual education on glycaemic control in a subgroup analysis of three studies involving participants with a higher mean baseline HbA1c greater than 8 % ( WMD -0.3 % ( 95 % CI -0.5 to -0.1 , P = 0.007 ) . In the two studies comparing individual to group education , there was no significant difference in glycaemic control between individual or group education at 12 to 18 months with a WMD in HbA1c of 0.03 % ( 95 % CI -0.02 to 0.1 , P = 0.22 ) . There was no significant difference in the impact of individual versus usual care or group education on body mass index systolic or diastolic blood pressure . There were too few studies to perform a meta- analysis on the effect of individual education on dietary self management , diabetes knowledge , psychosocial outcomes and smoking habits . No data were available on the other main outcome measures of diabetes complications or health service utilization and cost analysis in these studies . AUTHORS ' CONCLUSIONS This systematic review suggests a benefit of individual education on glycaemic control when compared with usual care in a subgroup of those with a baseline HbA1c greater than 8 % . However , overall there did not appear to be a significant difference between individual education and usual care . In the small number of studies comparing group and individual education , there was an equal impact on HbA1c at 12 to 18 months . Additional studies are needed to delineate these findings further
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"AIMS To assess the effect of regular diabetic health education on cardiovascular risk factors in Chinese Type 2 diabetic patients . METHODS This was a 1-year prospect i ve r and omized study . One hundred and eighty Type 2 diabetic subjects were recruited from three regional diabetic centres in Hong Kong . Ninety received additional structured reinforcement of diabetic health education by a trained nurse after the doctors ' consultations every 3 months ( intervention group ) . The others received the same medical care except no nursing reinforcement ( control group ) . Outcome measures included fasting plasma glucose , HbA(1c ) , body mass index , waist circumference , blood pressure and lipid profiles , which were assessed before the study and after 1 year . RESULTS Two of the controls defaulted follow-up . The intervention group and controls had similar age and sex distribution . At the end of study , the intervention group had reducted their waist circumference , diastolic blood pressure , HbA(1c ) , total cholesterol and low-density lipoprotein cholesterol levels . The controls had reduced their total cholesterol and low-density lipoprotein cholesterol levels . Other cardiovascular risk factors were not significantly changed in the controls . Addition of drugs and /or dosage increment of anti-diabetic drugs , lipid-lowering agents and anti-hypertensive agents were similar between the two groups . CONCLUSIONS Regular structured reinforcement with diabetic health education is useful . It helps to control more successfully some of the cardiovascular risk factors in Chinese Type 2 diabetic patients",
"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 Type 2 diabetes is up to four times more common in British Asians , but they know little about its management and complications . AIM To design and evaluate a structured pictorial teaching programme for Pakistani Moslem patients in Manchester with type 2 diabetes . METHOD A r and omized controlled trial of pictorial flashcard one-to-one education in 201 patients attending a hospital outpatient clinic or diabetic clinics in ten general practice s in Manchester . Patients ' knowledge , self-caring skills and attitudes to diabetes were measured on four topics before the structured teaching , and compared with results six months later . RESULTS All parameters of knowledge were increased in the study group ; for example , percentage scores for correctly identifying different food values increased from 57 % to 71 % ( Analysis of Variance ( ANOVA ) adjusted difference + 11.8 % ) and knowledge of one diabetic complication from 18 % to 78 % . Self-caring behaviour improved , with 92 % of patients doing regular glucose tests at six months compared with 63 % at the start . Attitudinal views were more resistant to change , with patients still finding it hard to choose suitable foods at social occasions . Haemoglobin A1c control improved by 0.34 % over six months ( ANOVA adjusted difference , 95 % CI -0.8 % to + 0.1 % ) . CONCLUSION It is concluded that this health education programme can empower Asian diabetics to take control of their diets , learn to monitor and interpret glucose results , and underst and the implication s of poor glycaemic control for diabetic complications",
"Aims /hypothesisThe aim of this study was to investigate the effectiveness of physical activity counselling in promoting physical activity in people with Type 2 diabetes and to evaluate result ant physiological and biochemical effects . Methods A total of 70 inactive people with Type 2 diabetes were given st and ard exercise information and r and omised to receive physical activity counselling ( n=35 , experimental ) or not ( n=35 , control ) . Physical activity consultations were delivered at baseline and after 6 months , with follow-up phone calls after 1 , 3 , 6 and 9 months . Changes from baseline after 6 and 12 months were assessed for physical activity ( 7-day recall and accelerometer ) , for physiological characteristics ( body mass index and blood pressure ) and for biochemical variables ( HbA1c , lipid profile , fibrinogen , tissue plasminogen activator and microalbuminuria ) . Results Significant differences between groups were recorded for physical activity after 6 and 12 months ( p levels of physical activity from baseline to 6 months ( p0.05 ) . In the control group , accelerometer counts per week decreased from baseline to 12 months ( p=0.03 ) . Between-group differences ( p HbA1c ( experimental : 0.26 % decrease ; control : 0.15 % increase ) , for systolic blood pressure ( experimental : 7.7 mm Hg decrease ; control : 5.6 mm Hg increase ) and for fibrinogen ( experimental : 0.28 mmol/l decrease ; control : 1.43 mmol/l increase ) from baseline to 6 months , and for total cholesterol ( experimental : 0.33 mmol/l decrease ; control : 0.04 mmol/l increase ) from baseline to 12 months ( p activity counselling was effective in promoting physical activity in people with Type 2 diabetes . The counselling improved glycaemic control as well as the status of cardiovascular risk factors in these patients",
"OBJECTIVE To examine the effect of a 12-month pharmaceutical care ( PC ) program on vascular risk in type 2 diabetes . RESEARCH DESIGN AND METHODS We recruited 198 community-based patients r and omized to PC or usual care . PC patients had face-to-face goal -directed medication and lifestyle counseling at baseline and at 6 and 12 months plus 6-weekly telephone assessment s and provision of other educational material . Clinical , biochemical , and medication-related data were sent regularly to each patient 's physician(s ) . The main outcome measure was change in HbA(1c ) . A diabetes-specific risk engine was used to estimate changes in 10-year coronary heart disease ( CHD ) and stroke risk in patients without a history of cardiovascular disease . RESULTS At total of 180 patients ( 91 % ) completed the study . Mean ( 95 % CI ) reductions were greater in PC case subjects ( n = 92 ) than control subjects ( n = 88 ) for HbA(1c ) ( -0.5 % [ 95 % CI -0.7 to -0.3 ] vs. 0 [ -0.2 to 0.2 ] ) and systolic ( -14 mmHg [ -19 to -9 ] vs. -7 [ -11 to -2 ] ) and diastolic ( -5 mmHg [ -8 to -3 ] vs. -2 [ -4 to 1 ] ) blood pressure ( P HbA(1c ) persisted after adjustment for baseline value and demographic and treatment-specific variables . The median ( interquartile range ) 10-year estimated risk of a first CHD event decreased in the PC case subjects ( 25.1 % [ 15.6 - 36.2 ] to 20.3 [ 14.6 - 30.2 ] ; n = 42 , P = 0.002 ) but not in the control subjects ( 26.1 % [ 17.2 - 39.4 ] vs. 26.4 [ 16.7 - 38.0 ] ; n = 52 , P = 0.17 ) . CONCLUSIONS A 12-month PC program in type 2 diabetes reduced glycemia and blood pressure . Pharmacist involvement contributed to improvement in HbA(1c ) independently of pharmacotherapeutic changes . PC could prove a valuable component of community-based multidisciplinary diabetes care",
"OBJECTIVE To assess the efficacy of a lifestyle intervention program that can be readily translated into clinical practice for obese patients with type 2 diabetes . RESEARCH DESIGN AND METHODS The study consisted of a 12-month r and omized controlled trial of 147 health plan members with type 2 diabetes and obesity ( BMI > or=27 kg/m(2 ) ) . Participants were r and omized to lifestyle case management or usual care . Case management entailed individual and group education , support , and referral by registered dietitians ; intervention cost was US dollars 350 per person . Individuals treated with usual care received educational material . Both groups received ongoing primary care . Outcomes were difference between groups for change in weight ( kilograms ) , waist circumference ( centimeters ) , HbA(1c ) , fasting lipid levels , use of prescription medications , and health-related quality of life . RESULTS Case management result ed in greater weight loss ( P reduced waist circumference ( P reduced HbA(1c ) level ( P = 0.02 ) , less use of prescription medications ( P = 0.03 ) , and improved health-related quality of life ( P weight loss and waist circumference was 3.0 kg ( 95 % CI -5.4 to -0.6 ) and -4.2 cm ( -6.8 to -1.6 ) . HbA(1c ) differences were greatest at 4 months ( -0.59 % , P = 0.006 ) but not significant by 12 months ( -0.19 % , P = 0.45 ) . Participants in the case management group lowered their use of medications , primarily diabetes medications , by 0.8 medications per day more than participants treated with usual care ( P = 0.03 ) . In seven of nine quality -of-life domains , the case management group improved compared with usual care ( P health indicators among obese patients with type 2 diabetes",
"OBJECTIVE To demonstrate improvements in diabetes care stimulated by comprehensive evaluation of community-based diabetic patients with feedback to the patients and their physicians . RESEARCH DESIGN AND METHODS A comprehensive evaluation of community-based diabetic patients with annotated reporting of results to both patients and their physicians ( universal intervention ) was followed by r and om assignment of 50 % of patients to individual counseling ( r and omized intervention ) . In four communities , two large and two small , 55 type 1 and 376 type 2 diabetic patients were recruited , evaluated , and reassessed at 1 year . Outcome measures were HbA1c , serum cholesterol , and systolic and diastolic blood pressure . RESULTS There were significant improvements in all outcome measures for type 2 diabetic patients r and omized to individual counseling ( P = 0.03 ; follow-up rate 84 % ) and significant improvements in all outcome measures for all high-risk type 2 patients ( highest P value = 0.004 ; follow-up rate 85 % ) . CONCLUSIONS Comprehensive evaluation of diabetic patients at the community level with annotated reporting of results to the patients and their physicians was associated with improvement of mean HbA1c , cholesterol , and systolic and diastolic blood pressure , particularly in patients in high-risk status for these outcome variables . Individual counseling of 50 % of patients , r and omly selected , enhanced these results",
"OBJECTIVE To evaluate the effectiveness of the Shanghai Chronic Disease Self-Management Program ( CDSMP ) . METHODS A r and omized controlled trial with six-month follow-up compared patients who received treatment with those who did not receive treatment ( waiting-list controls ) in five urban communities in Shanghai , China . Participants in the treatment group received education from a lay-led CDSMP course and one copy of a help book immediately ; those in the control group received the same education and book six months later . FINDINGS In total , 954 volunteer patients with a medical record that confirmed a diagnosis of hypertension , heart disease , chronic lung disease , arthritis , stroke , or diabetes who lived in communities were assigned r and omly to treatment ( n = 526 ) and control ( n = 428 ) groups . Overall , 430 ( 81.7 % ) and 349 ( 81.5 % ) patients in the treatment and control groups completed the six-month study . Patients who received treatment had significant improvements in weekly minutes of aerobic exercise , practice of cognitive symptom management , self-efficacy to manage own symptoms , and self-efficacy to manage own disease in general compared with controls . They also had significant improvements in eight indices of health status and , on average , fewer hospitalizations . CONCLUSION When implemented in Shanghai , the CDSMP was acceptable culturally to Chinese patients . The programme improved participants ' health behaviour , self-efficacy , and health status and reduced the number of hospitalizations six months after the course . The locally based delivery model was integrated into the routine of community government organizations and community health services . Chinese lay leaders taught the CDSMP courses as successfully as professionals",
"Background Epidemiologic data have shown that the prevalence of Type 2 diabetes varies with ethnic origin . Type 2 diabetes is up to four times more common in British South Asians than in the indigenous white population . The aim of this study was to develop a culturally appropriate educational intervention programme for South Asians with Type 2 diabetes . We then investigated whether this intervention could produce an improvement , and finally whether any improvement was greater than background changes in knowledge in comparison groups . Methods A multi-site prospect i ve , r and omised controlled study was conducted in all day care centres and three general practice registers with high proportion patients from different ethnic minority groups in Glasgow , Scotl and . The intervention consisted of 18 educational sessions in 6 separate programmes . A modified question naire was used to measure the knowledge , attitudes , and practice of diabetes before and after intervention . Results Baseline assessment showed that Indian and Pakistani subjects had less knowledge about diabetes , regarded the disease less seriously , and had a lesser underst and ing of the relationship between control and complications than the white population . No differences in initial responses were found between those who completed the second assessment and those who did not . The intervention group showed significant improvements in scores for Knowledge ( + 12.5 % ) ; Attitudes toward seriousness ( + 13.5 % ) , complications ( + 8.1 % ) , Practice ( + 20.0 % ) . However there were also changes in the ethnic control group scores ; respectively + 5.0 % , + 16.3 % ( significant P patients with Type 2 diabetes from ethnic minority groups is feasible and can improve their knowledge and attitudes and practice . However there was no net benefit compared with the control group",
"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",
"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 effect of case management by a clinical pharmacist on glycemic control and preventive measures in patients with type 2 diabetes mellitus . STUDY DESIGN R and omized controlled trial in a university-affiliated primary care internal medicine clinic . METHODS We recruited 80 patients with poorly controlled type 2 diabetes mellitus . A clinical pharmacist provided evaluation and modification of pharmacotherapy , self-management diabetes education , and reinforcement of diabetes complications screening processes through clinic visits and telephone follow-up . The main clinical outcome was hemoglobin A1C ( HbA1C ) level ; process measures included HbA1C and low-density lipoprotein measurement , retinal examination , urine microalbumin testing ( or use of angiotensin-converting enzyme inhibitors ) , and monofilament screening for diabetic neuropathy . RESULTS Patients in the intervention and control groups were similar in age , sex , mean HbA1C levels ( 10.1 % and 10.2 % , respectively ; P = .65 ) , and current treatment regimens at baseline . Patients who received case management by the clinical pharmacist achieved greater reduction in HbA1C levels than those in the control group ( 2.1 % vs 0.9 % , P = .03 ) . Three of the 5 process measures were conducted more frequently in the intervention group than the control group , including low-density lipoprotein measurement ( 100.0 % vs 85.7 % , P = .02 ) , retinal examination ( 97.3 % vs 74.3 % ) , and monofilament foot screening ( 92.3 % vs 62.9 % ) . CONCLUSIONS Proactive diabetes case management by a pharmacist substantially improved glycemic control and diabetes process-of-care measures . This approach , integrated with and based in the primary care setting , was an effective and efficient approach to improving care , especially for those with poor glycemic control at baseline",
"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",
"Lifestyle programmes delivered by academic nurse-counsellors in a primary care setting lowered blood pressure ( BP ) among at-risk patients . We examined whether the programmes could be successfully implemented by nurses employed in Australian general practice s. In a r and omised controlled trial , 212 of 591 eligible 20–75-year olds with hypertension , Type II diabetes or coronary disease from seven practice s volunteered . Patients were r and omised to : a ‘ Low ’ group with one face-to-face individual counselling session , then monthly telephone contacts for 1 year ( n=69 ) ; a ‘ High ’ group with individual face-to-face counselling up to 1 h monthly for 1 year ( n=74 ) or a control group receiving usual care only ( n=69 ) , and were evaluated at baseline and 12 and 18 months later ; 164 individuals completed the study . Patients ' usual doctors continued to prescribe in all groups . Changes in 24 h ambulatory BP did not differ significantly between groups at 12 months ( Low , −2±2/1±1 mmHg ; High , + 4±2/1± 1 mmHg ; usual care , + 1±2/1±1 mmHg ) or 18 months ( −2±2/2±1 mmHg ; −4±2/3±2 mmHg ; −1±2/2± 1 mmHg , respectively ) . Antihypertensive drugs prescribed decreased by 12 months in 33 % of the High , 5 % of the Low and 13 % of the control groups ( P=0.008 ) and by 36 , 7 and 16 % at 18 months ( P=0.018 ) . After 18 months , targets for BP control were not met in about 60 % of patients and almost 50 % had clinic BP above 140/90 mmHg . Year-long interaction with nurse-counsellors may influence longer-term antihypertensive drug prescription , possibly by improving compliance . Suboptimal BP control suggests that continuing physician education on BP targets is needed",
"We studied the impact of nurse case management ( NCM ) on blood pressure ( BP ) , hemoglobin A1C , lipids , and diabetes complication screening . A 1-year r and omized-controlled trial was conducted in two primary care clinics of the Penn State Hershey Medical Center . Diabetes patients were r and omized to control group ( CG ) ( n=182 ) who received usual care by their primary care provider and intervention group ( IG ) ( n=150 ) who received additional NCM care , including self-management education , and implementation of diabetes guidelines . Primary outcomes included BP , A1C , lipid , process measures , and secondary outcome was diabetes-related emotional distress as assessed by Problem Areas in Diabetes ( PAID ) . BP significantly decreased from 137/77 to 129/72 in IG as compared to an increase from 136/77 to 138/79 in CG after 1 year . PAID scores improved significantly in IG ( from 23 to 10 ) due to reduced emotional stress . A1C ( 7.4 ) and LDL ( 105 ) were unaffected . Complications screening significantly improved in IG compared to CG : opthalmologic exam 26 to 68 % , foot exam 47 to 64 % , and nephropathy screening 34 to 72 % . NCM improved BP , diabetes-related emotional distress , and process measures in primary care . Unchanged A1C and lipids might be due to a threshold effect . Intervention based upon initial risk assessment may prove more cost-effective ",
"In this r and omized trial patients with non-insulin-dependent diabetes were allocated to one of four programs : a minimal instruction program ( n=59 ) . an education program of individual visits ( n=57 ) , an education program incorporating a group education course ( n=66 ) , and a behavioral program ( n=59 ) . Individual and group education programs had higher attrition rates than the behavioral and minimal programs . The four programs , which involved different amounts of patient contact time , delivery format , and instructional strategies . all produced reductions in HbA atid BMI , with no significant differences between the programs . There were no differences between groups over three time periods in total cholesterol , HDL cholesterol , systolic blood pressure , or proportion of patients consulting an ophthalmologist . The behavioral program ploduced a greater reduction in diastolic blood pressure over 12 months that the education programs and a greater reduction in the cholesterol risk ratio over 3 months than the other programs . The behavioral program patients were more likely to have visited a podiatrist after 6 months and reported higher satisfaction",
"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",
"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",
"OBJECTIVE The objective of this study was to evaluate the impact of a problem-based empowerment patient education program specifically tailored for urban African Americans with type 2 diabetes . RESEARCH DESIGN AND METHODS The study used a r and omized controlled trial ( RCT ) pretest/post-test design with repeated measures . Patients were r and omly assigned to either a six-week intervention group or a six-week wait-listed control group . After completing the six sessions , patients were invited to participate in one of two follow-up conditions ; attend a monthly support group or receive a monthly phone call from a nurse . Assessment measures included HbA1C , lipids , blood pressure , weight , self-management behavior and psychosocial adaptation . RESULTS Both control and intervention patients showed a broad array of small-to-modest positive changes during the six-week RCT . These gains were maintained or improved upon during the one-year follow-up period . For patients in the two follow-up conditions , a positive correlation was seen between the number of follow-up contacts and their one-year HbA1C values . CONCLUSIONS We believe that results of this study can be attributed to volunteer bias , study effects ( ie , providing study data on several occasions to patients and their physicians during the one-year study period ) , and impact of the interventions . However , the study design does not allow us to examine the relative impact of these three factors on the patient improvements seen over the one-year study period",
"Two diabetes education programs were compared to a control condition . Seventy-eight type II ( non-insulindependent ) diabetic out patients were r and omly assigned to nutrition education , nutrition education plus social learning intervention , or wait-list control conditions . Both interventions involved five weekly meetings that focused on reducing calorie intake , increasing dietary fiber , and decreasing fat consumption . The social learning condition also included individualized goal setting and feedback and training in problem-solving and relapse prevention . Within-group analyses and between-group comparisons generally revealed greater improvement in targeted goals ( e.g. , calorie intake , fat reduction ) among intervention conditions than the control condition . There were few differences in more distal measures of outcome such as weight or glycosylated hemoglobin . The social learning component did not improve outcome more than the nutrition education program . Possible reasons for the observed findings and the advantages and limitations of focused time-limited diabetes education efforts are discussed",
"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",
"AIMS Education is an essential part of the management of patients with Type 2 diabetes , but the long-term effects are unclear and not well investigated in primary care . METHODS Fifty-four patients ( 39 - 75 years ) treated with maximal dosages of oral hypoglycaemic agents , needing to start insulin ( HbA(1c ) > or = 7.0 % ) , were r and omly allocated to a 6-month educational programme by a diabetes nurse ( DN group ) or usual care ( UC group ) . Main outcome measures were HbA(1c ) , number of patients with HbA(1c ) , and number of patients treated with insulin 18 months after baseline . RESULTS Six weeks after the intervention HbA(1c ) levels had improved from 8.2 ( 1.1 ) to 7.2 ( 1.3 ) in the DN group , and from 8.8 ( 1.5 ) to 8.4 ( 1.7 ) in the UC group . Adjusted for baseline values , at 6 weeks HbA(1c ) improved 0.7 % ( 95 % confidence interval 0.1 , 1.4 ) more in DN than in UC . Of the patients in DN , 60 % reached HbA(1c ) HbA(1c ) , number of patients with HbA(1c ) 7.0 % , or number treated with insulin . CONCLUSIONS Education was effective in improving glycaemic control and in delaying the need for insulin therapy in patients treated with maximal oral hypoglycaemic therapy . The reduced effect after 1 year was probably due to the discontinuation of the educational programme . Short-term education should not be offered without regular reinforcements integrated into st and ard diabetes care",
"Despite the established role of foot care education in diabetes management , reports evaluating such interventions are rare . The effectiveness of an intensive foot care intervention programme and a conventional one were therefore compared in Type 2 diabetes . The intensive group showed significantly greater improvements than the conventional group in foot care knowledge ( p less than 0.001 ) , compliance with the recommended foot care routine ( p = 0.012 ) , and compliance with the initial advice to consult a podiatrist ( other than the project podiatrist ) for further treatment ( p = 0.008 ) . At the first follow-up visit the intensive group also showed a significantly greater reduction in the number of foot problems requiring treatment than the conventional group",
"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",
"Abstract Objective : To determine the relation between exposure to glycaemia over time and the risk of macrovascular or microvascular complications in patients with type 2 diabetes . Design : Prospect i ve observational study . Setting : 23 hospital based clinics in Engl and , Scotl and , and Northern Irel and . Participants : 4585 white , Asian Indian , and Afro-Caribbean UKPDS patients , whether r and omised or not to treatment , were included in analyses of incidence ; of these , 3642 were included in analyses of relative risk . Outcome measures : Primary predefined aggregate clinical outcomes : any end point or deaths related to diabetes and all cause mortality . Secondary aggregate outcomes : myocardial infa rct ion , stroke , amputation ( including death from peripheral vascular disease ) , and microvascular disease ( predominantly retinal photo-coagulation ) . Single end points : non-fatal heart failure and cataract extraction . Risk reduction associated with a 1 % reduction in up date d mean HbA1c adjusted for possible confounders at diagnosis of diabetes . Results : The incidence of clinical complications was significantly associated with glycaemia . Each 1 % reduction in up date d mean HbA1c was associated with reductions in risk of 21 % for any end point related to diabetes ( 95 % confidence interval 17 % to 24 % , P deaths related to diabetes ( 15 % to 27 % , P myocardial infa rct ion ( 8 % to 21 % , P microvascular complications ( 33 % to 41 % , P patients with type 2 diabetes the risk of diabetic complications was strongly associated with previous hyperglycaemia . Any reduction in HbA1c is likely to reduce the risk of complications , with the lowest risk being in those with HbA1c values in the normal range ( < 6.0 % )",
"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",
"SUMMARY",
"AIMS The aims of this study were to assess whether , in Type 2 diabetic patients with inadequate glycaemic control on oral hypoglycaemic agents ( OHA ) , a lifestyle intervention programme based on exercise and diet counselling ( i ) was as effective as insulin treatment in controlling blood glucose , and ( ii ) could prevent the weight gain usually accompanying the introduction of insulin treatment . METHODS Thirty-eight Type 2 diabetic subjects treated with OHA , HbA(1c ) 8 - 10.5 % and body mass index ( BMI ) 26 - 40 kg/m2 , were r and omized to the following treatments : ( i ) lifestyle intervention ( L ) , ( ii ) lifestyle intervention + insulin treatment ( L+I ) and ( iii ) insulin treatment alone ( I ) . RESULTS There was a reduction in HbA(1c ) of -1.2 ( interquartile range 1.0 ) , -1.0 ( 1.7 ) and -1.5 (2.5)% in group L , L+I and I , respectively , and all treatment groups achieved beneficial changes in blood lipid variables . There was no significant difference between the groups in the change observed in levels of HbA(1c ) between start and 12 months of treatment ( P = 0.74 ) . There was a significant difference in weight changes between groups ( P reduced weight by median -3.0 ( 4.0 ) kg , groups L+I and I increased weight by 3.5 ( 3.4 ) and 4.9 ( 6.9 ) kg , respectively . CONCLUSIONS Lifestyle intervention was as effective as insulin treatment in improving glycaemic control in poorly controlled subjects with Type 2 diabetes , and result ed in weight loss during the intervention year . However , glycaemic control deteriorated and body weight increased in the lifestyle intervention group 1 year after the intervention stopped",
"Previous research has pointed to the efficacy of physical activity in individuals suffering from type 2 diabetes mellitus ( type 2 DM ) . However , as with other population s , adherence to exercise programs is often problematic . This study assessed the effectiveness of a combination of exercise and psychological interventions in type 2 diabetics in terms of disease management and exercise adherence . Forty newly diagnosed type 2 diabetic subjects ( 54 + /- 6.5 years ) took part in the study . Subjects were allocated to an exercise-only intervention ( EO ) or a combined exercise and psychological adherence intervention ( EP ) group . Adherence to the program was also monitored at a 6-month follow-up . The results confirmed a significant improvement in physiological parameters ( total mass , fat mass , grip strength , peak flow , flexibility , and VO2 max ) after the 12-week program in both groups ( P body fat , grip strength , and peak flow ( P visual analog mood scale ( VAMS ) were positively influenced in both groups from the therapy program ( P psychological intervention had a significant influence on attendance to the 12-week program ( P adherence 6 months later ( P adherence rates during exercise therapy for type 2 diabetic subjects",
"AIMS The efficacy of three education programmes for Type 2 diabetic patients was tested in a r and omized trial . A didactic-oriented training programme ( treatment A ) was compared with a self-management-oriented programme delivered in group sessions ( treatment B ) . The latter programme was compared with a more individualized approach ( treatment C ) . METHODS One hundred and eighty-one Type 2 diabetic patients ( age 55.6 + /- 6.3 years , diabetes duration 6.6 + /- 6.2 years , HbA(1c ) 7.8 + /- 1.6 % , female 49.7 % ) took part . Efficacy was assessed 3 months ( t1 ) after baseline ( t0 ) and at a follow-up 15 months ( t2 ) after baseline . RESULTS The fall in HbA(1c ) in treatment B at t1 was sustained at t2 ( t0 8.1 + /- 1.8 % , t1 7.3 + /- 1.7 % , t2 7.4 + /- 1.9 % ) . In treatment A , HbA(1c ) was unchanged throughout ( t0 7.6 + /- 1.5 % , t1 7.5 + /- 1.3 % , t2 7.7 + /- 1.7 % ; treatment A vs. treatment B ; P fall in HbA(1c ) at t1 , but this was not sustained at t2 ( t0 7.8 + /- 1.6 % , t1 7.1 + /- 1.3 % , t2 7.6 + /- 1.6 % ; treatment B vs. treatment C ; P = 0.73 ) . There were also significant benefits in treatment B subjects compared with treatment A in further medical ( body mass index and fasting blood glucose ) , psychological ( control , irritability and hunger dependency of eating behaviour , and trait anxiety ) and behavioural ( exercise ) variables . There were no significant benefits of the more individualized treatment C compared with group treatment B. No significant differences were found regarding triglyceride levels , high-density lipoprotein , diabetes-related knowledge , negative well-being , urine or blood glucose levels or foot care . CONCLUSION Self-management training had a significantly higher medium-term efficacy than didactic diabetes education . The group sessions were more effective than a more individualized approach",
"This study examined diabetes-related health disparities in a Latino population in terms of prevalence of the disease , and the extent to which practice -based interventions improve health care and health for the Latinos who have diabetes . Previous research has shown that Latinos , overall , are at greater risk for diabetes , but less is known for those of Puerto Rican and Dominican origin . Two interventions were implemented in a large primary care practice : an ADA-recognized Diabetes Self Management Education program , and clinical information feedback loops to providers regarding adherence to the Massachusetts Guidelines for the Care of Diabetes . The study identified the prevalence of diabetes to be 13.7 % among Puerto Ricans , and 9.1 % among Dominicans , rates 2-to-3 times that for the general population . Latino patients ( N=567 ) who participated in a Diabetes Self Management Education Program maintained lower Hb A1c values than did a comparison group ( N=432 ) . For a r and om sample of Latinos with diabetes ( N=98 ) in this study , 6 measures of health care improved significantly from 2001 to 2003 . Areas of improvement among healthcare providers were : ordering a microalbumin level measurement when appropriate , prescribing ACE inhibitors as needed , providing pneumococcal and influenza vaccines , review ing activity status and exercise , identifying smoking status , and prescribing lipid-lowering agents , as appropriate . Body mass index ( BMI ) for the 98 patients remained the same for both measurement periods at 32.8 . Although this initial study spanned only 2 years , improvements in health care and health indices for the population are encouraging . Further study is underway to exp and on these gains",
"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",
"Background In light of health disparities and the growing prevalence of chronic disease , there is a need for community-based interventions that improve health behaviors and health status . These interventions should be based on existing theory . Objective This study aim ed to evaluate the health and utilization outcomes of a 6-week community-based program for Spanish speakers with heart disease , lung disease , or type 2 diabetes . Method The treatment participants in this study ( n = 327 ) took a 6-week peer-led program . At 4 months , they were compared with r and omized wait-list control subjects ( n = 224 ) using analyses of covariance . The outcomes for all the treatment participants were assessed at 1 year , as compared with baseline scores ( n = 271 ) using t-tests . Results At 4 months , the participants , as compared with usual-care control subjects , demonstrated improved health status , health behavior , and self-efficacy , as well as fewer emergency room visits ( p the lives of Hispanics with chronic illness while reducing emergency room use",
"OBJECTIVE To determine the effects of a culturally appropriate diabetes lifestyle intervention for Native Americans on risk factors for complications of diabetes . RESEARCH DESIGN AND METHODS A nonr and omized , community-based diabetes intervention trial was conducted in three Native American sites in New Mexico from 1993 - 1997 . Participants were assigned to intervention or control based on community of residence . Intervention sessions were held approximately 6 weeks apart over approximately 10 months . The intervention was delivered in site A in family and friends ( FF ) groups ( n = 32 ) ; site B received the same intervention in one-on-one ( OO ) appointments ( n = 39 ) ; and site C received usual medical care ( UC ) ( n = 33 ) ( total participants , n = 104 ) . Primary change in HbA(1c ) level was assessed at 1 year . RESULTS Adjusted mean change in HbA(1c ) value varied significantly across the three arms at 1 year ( P = 0.05 ) . The UC arm showed a statistically significant increase in adjusted mean HbA(1c ) change ( 1.2 % , P = 0.001 ) , whereas both intervention arms showed a small nonsignificant ( P > 0.05 ) increase in the adjusted mean change ( 0.5 % and 0.2 % for FF and OO arms , respectively ) . The increase was statistically significantly smaller in the combined intervention arms ( 0.4 % ) compared with the UC arm ( 1.2 % , P = 0.02 ) . CONCLUSIONS Lifestyle intervention has the potential to substantially reduce microvascular complications , mortality , and health care utilization and costs if the change is sustained over time",
"OBJECTIVE To improve clinical diabetes care , patient knowledge , and treatment satisfaction and to reduce health-adverse culture-based beliefs in underserved and underinsured population s with diabetes . RESEARCH DESIGN AND METHODS A total of 153 high-risk patients with diabetes recruited from six community clinic sites in San Diego County , California were enrolled in a nurse case management ( NCM ) and peer education/empowerment group . Baseline and 1-year levels of HbA(1c ) , lipid parameters , systolic and diastolic blood pressure , knowledge of diabetes , culture-based beliefs in ineffective remedies , and treatment satisfaction were prospect ively measured . The NCM and peer education/empowerment group was compared with 76 individuals in a matched control group ( CG ) derived from patients referred but not enrolled in Project Dulce . RESULTS After 1 year in Project Dulce , the NCM and peer education/empowerment group had significant improvements in HbA(1c ) ( 12.0 - 8.3 % , P total cholesterol ( 5.82 - 4.86 mmol/l , P LDL cholesterol ( 3.39 - 2.79 mmol/l , P diastolic blood pressure ( 80 - 76 mmHg , P diabetes care , knowledge of diabetes ( P = 0.024 ) , treatment satisfaction ( P = 0.001 ) , and culture-based beliefs ( P = 0.001 ) were also improved . CONCLUSIONS A novel , culturally appropriate , community-based , nurse case management/peer education diabetes care model leads to significant improvement in clinical diabetes care , self-awareness , and underst and ing of diabetes in underinsured population",
"Abstract .Practicing physicians as well as diabetes specialists are confronted with the often-frustrating experience of dealing with patients with poorly controlled diabetes . It is not always obvious why these patients fail to improve . The aims of this study were two-fold : ( a ) to determine if the interdisciplinary approach offered by the Western Negev Mobile Clinic Diabetes Program ( WNMDCP ) is of benefit in patients with poorly controlled type 2 diabetes and ( b ) to more fully characterize patients refractory to treatment . Two primary -care clinics of the Western Negev were r and omly selected as control and intervention . All patients from both clinics with hemoglobin ( HbA1C ) ≥10 % ( tested during June-July 2000 ) were studied for 6 months . Patients from the control clinic continued the usual treatment . Patients from the intervention clinic received the interdisciplinary approach offered by WNMCDP . The rate of improvement of diabetes control , measured as a decrease in HbA1C values of at least 0.5 % , and compliance to treatment were determined . Overall , 48 of 258 patients in the intervention clinic and 34 of 179 patients in the control clinic met the inclusion criteria . At the 6-month follow-up , we observed significant improvements in plasma glucose ( -1.5 mmol/l ; p=0.003 ) and HbA1C ( -1.8 % ; p=0.00001 ) in the intervention group but not in the control group . The compliance and response rates were 85 % and 71 % for the intervention group and 32 % and 35 % for the control group , respectively . Patients from the intervention clinic showed significant improvement in the endpoints compared to patients from the control clinic . More than 70 % of patients with poorly controlled diabetes mellitus responded to the interdisciplinary treatment approach offered by WNMDCP . The group of non-responders comprised patients with poor compliance ( 15 % ) and those with serious concomitant diseases or limitations of mobility",
"SUMMARY",
"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",
"PURPOSE The purpose of this pilot study was to determine the efficacy of a 6-month nurse-coaching intervention that was provided after diabetes education for women with type 2 diabetes . METHODS In this pilot study , 53 women were r and omized to the nurse-coaching intervention or a st and ard care control condition . The nurse-coaching intervention consisted of 5 individualized sessions and 2 follow-up phone calls over 6 months . The nurse-coaching sessions included educational , behavioral , and affective strategies . Data were collected on physiologic adaptation ( hemoglobin A1c [ A1C ] and body mass index [ BMI ] ) , self-management ( dietary and exercise ) , psychosocial adaptation ( diabetes-related distress and integration ) , and treatment satisfaction at baseline , 3 months , and 6 months . RESULTS Women in the treatment group demonstrated better diet self-management , less diabetes-related distress , better integration , and more satisfaction with care , and had trends of better exercise self-management and BMI . The A1C levels improved in both groups at 3 months , yet the difference between the groups was not significant . Attendance at nurse-coaching sessions was 96 % . CONCLUSIONS This nurse-coaching intervention demonstrates promise as a means of improving self-management and psychosocial outcomes in women with type 2 diabetes",
"AIMS Patient education is a very important part of diabetes care . However , until now , little data has been presented about the long-term effectiveness of structured intensive diabetes education programmes ( SIDEP ) for people with Type 2 diabetes mellitus . METHODS People with Type 2 diabetes ( n = 547 ) hospitalized from December 1999 to December 2000 were r and omly assigned to two groups . Two hundred and nineteen patients undertook an inpatient SIDEP and the remaining patients received conventional glycaemic control without intensive education . After discharge , all patients were monitored regularly . Laboratory data were obtained , and adherence to self-care behaviour was determined on a five-point scale by question naires completed annually . RESULTS Of the patients who completed the SIDEP , 160 ( 73.1 % ) were followed up for more than 4 years . The mean HbA(1c ) ( 7.9 + /- 1.2 vs. 8.7 + /- 1.6 % ; P frequency of hospitalization related to diabetes per patient per year ( 0.3 + /- 0.6 vs. 0.8 + /- 0.9 ; P adhered more closely to self-care behaviour than the control group over 4 years ( P People with Type 2 diabetes mellitus of longer duration and those treated with insulin had poorer HbA(1c ) at follow-up . CONCLUSIONS A well- design ed , intensive patient education programme is necessary for people with diabetes . However , regular and sustained reinforcement with encouragement is also required to maintain optimal glycaemic control , especially in insulin-treated patients ",
"We assessed diabetes education and peer support interventions as facilitators of weight loss and glycemic control in a community sample of 79 elderly persons with noninsulin-dependent diabetes mellitus ( NIDDM ) . Different groups received : education only , education and peer support , and no treatment . Peer support was higher in groups where it was actively facilitated . Weight loss and reduction in level of glycemic control occurred within groups receiving both diabetes education and peer support",
"Compliance with dietary recommendations and the effect of intensified dietary therapy on energy and nutrient intakes and fatty acid composition of serum lipids were studied in 86 obese subjects ( aged 40 to 64 years ) with recently diagnosed non-insulin-dependent diabetes mellitus ( NIDDM ) . After three months of basic education , the subjects were r and omly separated into an intervention group ( n = 40 ) and a conventional treatment group ( n = 46 ) . Members of the intervention group participated in 12 months of intensified education ; those in the conventional group visited local health centers . Compliance with dietary instructions was monitored through food records . Intensified dietary therapy result ed in greater weight loss , better metabolic control , and a less atherogenic lipid profile than conventional treatment . Intake of energy and saturated fatty acids tended to decline in the intervention group . A higher percentage of patients in the intervention group had a total fat intake of 30 % of energy or less after 15 months ( 32.5 % [ 12 of 38 ] vs 17.4 % [ 8 of 46 ] ) . Similarly , more patients in the intervention group had a saturated fatty acid intake of 10 % or less of total energy intake at the end of the study ( 35.0 % [ 13 of 38 ] vs 8.7 % [ 4 of 46 ] ) . The mean dietary cholesterol intake was within recommendations in both groups at the end of the study . The relative percentage of linoleic acid of serum lipids increased significantly and the relative percentage of palmitic acid of serum triglycerides , phospholipids , and cholesterol esters decreased in the intervention group . These changes indicate that intensified dietary therapy improved the quality of fat in the diet of patients with NIDDM",
"This paper explores a trial of an educational intervention design ed for people who have Type 2 diabetes . The aim of the trial was to underst and how the intervention had influenced outcomes in the context of participants ' everyday lives . A r and omised-controlled wait-list trial design was used . The study was also informed by a qualitative approach which explored the meanings held by participants for informing their behaviours . Outcomes were measured using diabetes-specific question naires and clinical measures of blood glucose control , weight and drug treatment . Alongside these , focus group discussion s were held to explore how outcome effects had transpired . Using these different methods result ed in two separate data sets which required diverse methods for analysis . This paper uses examples of compatibilities and contradictions between the data sets to look at how they were combined to produce valid results . Conclusions drawn showed that a combined methods approach was essential to exp and the scope and improve the analytic power of trials of patient education . It produced illuminating results which provided guidelines for practice and suggested further areas for research",
"OBJECTIVE This study compared diabetes Treatment As Usual ( TAU ) with Pathways To Change ( PTC ) , an intervention developed from the Transtheoretical Model of Change ( TTM ) , to determine whether the PTC intervention would result in greater readiness to change , greater increases in self-care , and improved diabetes control . RESEARCH DESIGN AND METHODS Participants were stratified by diabetes treatment and r and omized to treatment with PTC or TAU as well as being r and omized regarding receipt of free blood testing strips . The PTC consisted of stage-matched personalized assessment reports , self-help manuals , newsletters , and individual phone counseling design ed to improve readiness for self-monitoring of blood glucose ( SMBG ) , healthy eating , and /or smoking cessation . A total of 1029 individuals with type 1 and type 2 diabetes who were in one of three pre-action stages for either SMBG , healthy eating , or smoking were recruited . RESULTS For the SMBG intervention , 43.4 % of those receiving PTC plus strips moved to an action stage , as well as 30.5 % of those receiving PTC alone , 27.0 % of those receiving TAU plus strips , and 18.4 % of those receiving TAU alone ( P PTC than TAU ( 32.5 vs. 25.8 % ) moved to action or maintenance ( P PTC ( 24.3 % ) than TAU ( 13.4 % ) moved to an action stage ( P PTC result ed in a greater reduction of HbA(1c ) than TAU , but this did not reach statistical significance . However , in those who moved to an action stage for the SMBG and healthy eating interventions , HbA(1c ) was significantly reduced ( P percentage of calories from fat to a greater extent ( 35.2 vs. 36.1 % , P = 0.004 ) , increased servings of fruit per day ( 1.89 vs. 1.68 , P = 0.016 ) , and increased vegetable servings ( 2.24 vs. 2.06 , P = 0.011 ) but did not decrease weight . However , weight loss for individuals who received the healthy eating intervention and who increased SMBG frequency as recommended was significantly greater , with a 0.26-kg loss in those who remained in a pre-action SMBG stage but a 1.78-kg loss in those performed SMBG as recommended ( P individuals with diabetes , not just the minority who are ready for change",
"The Diabetes Education Study ( DIABEDS ) was a r and omized , controlled trial of the effects of patient and physician education . This article describes a systematic education program for diabetes patients and its effects on patient knowledge , skills , self-care behaviors , and relevant physiologic outcomes . The original sample consisted of 532 diabetes patients from the general medicine clinic at an urban medical center . Patients were predominantly elderly , black women with non-insulin-dependent diabetes mellitus of long duration . Patients r and omly assigned to experimental groups ( N = 263 ) were offered up to seven modules of patient education . Each content area module contained didactic instruction ( lecture , discussion , audio-visual presentation ) , skill exercises ( demonstration , practice , feedback ) , and behavioral modification techniques ( goal setting , contracting , regular follow-up ) . Two hundred seventy-five patients remained in the study throughout baseline , intervention , and postintervention periods ( August 1978 to July 1982 ) . Despite the requirement that patients demonstrate mastery of educational objectives for each module , postintervention assessment 11–14 mo after instruction showed only rare differences between experimental and control patients in diabetes knowledge . However , statistically significant group differences in self-care skills and compliance behaviors were relatively more numerous . Experimental group patients experienced significantly greater reductions in fasting blood glucose ( −27.5 mg/dl versus −2.8 mg/dl , P and glycosylated hemoglobin ( −0.43 % versus + 0.35 % , P effects on body weight , blood pressure , and serum creatinine . Continued follow-up is planned for DIABEDS patients to determine the longevity of effects and subsequent impact on emergency room visits and hospitalization",
"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",
"OBJECTIVES We evaluated lifestyle interventions for diabetic persons who live in rural communities . METHODS We conducted a 12-month r and omized clinical trial ( n = 152 ) of \" intensive-lifestyle \" ( modeled after the NIH Diabetes Prevention Program ) and \" reimbursable-lifestyle \" ( intensive-lifestyle intervention delivered in the time allotted for Medicare reimbursement for diabetes education related to nutrition and physical activity ) interventions with usual care as a control . RESULTS Modest weight loss occurred by 6 months among intensive-lifestyle participants and was greater than the weight loss among usual-care participants ( 2.6 kg vs 0.4 kg , P lost 2 kg or more than usual-care participants ( 49 % vs 25 % , P weight change were observed between reimbursable-lifestyle and usual-care participants . Glycated hemoglobin was reduced among all groups ( P Improvement in both weight and glycemia was attainable by lifestyle interventions design ed for persons who had type 2 diabetes and lived in rural communities"
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41173232-06ff-11f0-808a-c43d1ab1c353
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Proponents of evidence -based medicine ( EBM ) emphasize that conclusions about medical interventions should be based on controlled trials with clinical ly relevant outcomes , so that the greatest weight should be given to the systematic review s of the trials . One of the most comprehensive EBM data bases is the Cochrane Library , which contains thous and s of systematic review s on medical interventions . The Cochrane review on vitamin C and the common cold analyzed 29 trial comparisons on the preventive effects of vitamin C , 29 comparisons on the effect of regular vitamin C on common cold duration and severity , and 7 comparisons on the therapeutic effect of vitamin C. The review concludes : ‘ ‘ Implication s for practice : The prophylaxis trials found a reduction in common cold duration of 8 % in adults and 13 % in children . . . . So far , therapeutic supplementation has not been shown to be effective . Nevertheless , given the consistent effect of vitamin C on duration and severity in the regular supplementation studies , and the low cost and safety , it may be worthwhile for common cold patients to test on an individual basis whether therapeutic vitamin C is beneficial for them . ’ ’ In their review discussing the effect of dietary supplements on the common cold , Mathes and Bellanger refer to 9 papers and state that ‘ ‘ various trials have shown no difference in either duration , or severity of symptoms , when vitamin C was compared to placebo . In addition , numerous trials have shown no difference regarding the most commonly studied endpoint : frequency of symptoms . ’ ’ Since the conclusions of the Cochrane review diverge considerably from the conclusions of Mathes and Bellanger , it is useful to look at the findings of the studies they refer to . Some of the findings are inconsistent with their statements . Pitt and Costrini found statistically significant ( P[2-tail]1⁄4 .024 ) yet small reduction in common cold severity among US Marines who were administered 2 g/day vitamin C. Van Straten and Joslin reported a highly significant reduction in the number of participants who had 2 colds during their trial ( 2/84 vs 16/84 ; P 1⁄4 .0004 ) by 1 g/day vitamin C. Ludvigsson et al found a 14 % reduction ( P 1⁄4 .016 ) in the duration of ‘ ‘ absence from school because of upper respiratory tract infection ’ ’ in their main trial , and a 39 % reduction ( P 1⁄4 .004 ) in the duration of ‘ ‘ upper respiratory tract infection ’ ’ in their smaller trial when schoolchildren were administered 1 g/day of vitamin C. Terrence And erson carried out 3 vitamin C trials in Canada in the 1970s . In their first trial , And erson et al administered 1 g/day vitamin C regularly and 3 g/day extra when a participant caught the common cold . They found a 30 % ( P 1⁄4 .01 ) decrease in the number of days confined indoors in the vitamin C group . Furthermore , staying free of illness during the study period is also a relevant measure of effect and And erson et al found 8 percentage point increase in the proportion of participants who were ‘ ‘ not ill during the trial , ’ ’ ‘ ‘ not confined to the house , ’ ’ and ‘ ‘ not off work ’ ’ in the vitamin C group ( P 1⁄4 .01 ) . In their second trial , And erson et al were ambitious and they had 2 placebo arms and 6 vitamin C arms with different dosages . There were technical problems such as the mislabeling of bottles of tablets , and therefore no firm conclusions can be drawn from the second trial . Nevertheless , in the vitamin C arm which was administered 8 g of vitamin C only on the first day , 6.6 percentage points ( P 1⁄4 .046 ) more participants had colds lasting for only 1 day , compared with the arm administered 4 g of vitamin C , which suggests dose dependency . In their third trial , And erson et al administered 1 to 1.5 g/day of vitamin C therapeutically so that supplementation was initiated when a person caught a cold . They found a reduction in ‘ ‘ days spent indoors per subject ’ ’ by 25 % ( P 1⁄4 .048 ) among the vitamin C participants . These 7 controlled trials described above do not support Mathes and Bellanger ’s statements although the studies are provided as references . Furthermore , Mathes and Bellanger do not describe their rationalization to select the 9 references out of several dozens . In systematic review s , it is important to describe the selection criteria , in order to prevent bias caused by selecting studies that are consistent with the review ers ’ preconceptions . If Mathes and Bellanger were not ready to carry out their own systematic review , they should have taken a look at the Cochrane review which used explicit selection criteria and included all studies fulfilling those criteria . The main findings of the Cochrane review are as follows . In 5 trials with participants under heavy acute physical stress ( 3 with marathon runners ) , vitamin C reduced the incidence of colds by 52 % ( 95 % CI : 36 % to 65 % ) , but there is no evidence that vitamin C prevents colds in the general population . In
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"During 7 weeks in the spring of 1973 a double-blind pilot study on 172 children in the age group 8 - 9 was carried out to test the possible effect of 1000 mg vitamin C daily as a prophylactic agent against common colds . During the autumn of 1973 , a main study was carried out on 642 children of the same age . The investigations had the same pattern and lasted for 3 months . Both studies have been processed on the same principles . The results were somewhat divergent but , like previously published studies on children , seemed to indicate that the duration and severity of the cold were reduced while , on the other h and , the incidence remained unaltered or indeed increased . The total number of days of upper respiratory tract infection was smaller for the vitamin C group only in the pilot study ( not in the main study ) . No proven biochemical effects were obtained . Preventive treatment of healthy children with vitamin C in large doses this had no definitely proved effect against colds",
"A prospect i ve , r and omized , double-blind study was carried out to determine whether vitamin C prophylaxis , 2.0 g/day , vs placebo prophylaxis would reduce the incidence or morbidity of the common cold and other respiratory illnesses in 674 marine recruits during an eight-week period . Whole-blood ascorbic acid levels measured six weeks after initiation of the study were significantly higher in the vitamin C group . There was no difference between the two groups in the incidence or duration of colds . The vitamin C group rated their colds as being less severe , but this was not reflected in different symptom complexes or in fewer sick-call visits or training days lost . This study and the literature do not support the prophylactic use of vitamin C to prevent the common cold",
" One hundred sixty-eight volunteers were r and omized to receive a placebo or a vitamin C supplement , two tablets daily , over a 60-day period between November and February . They used a five-point scale to assess their health and recorded any common cold infections and symptoms in a daily diary . Compared with the placebo group , the active-treatment group had significantly fewer colds ( 37 vs 50 , P days challenged virally ( 85 vs 178 ) , and a significantly shorter duration of severe symptoms ( 1.8 vs 3.1 days , P get a cold and recovered faster if infected . Few side effects occurred with the active treatment , and volunteers reported greatly increased satisfaction with the study supplement compared with any previous form of vitamin C. This well-tolerated vitamin C supplement may prevent the common cold and shorten the duration of symptoms . Volunteers were generally impressed by the protection afforded them during the winter months and the general acceptability of the study medication",
"A large scale double-blind trial was conducted to test the cl aim that the intake of one gram of vitamin C per day substantially reduces the frequency and duration of \" colds \" . It was found that in terms of the average number of colds and days of sickness per subject the vitamin group experienced less illness than the placebo group , but the differences were smaller than have been cl aim ed and were statistically not significant . However , there was a statistically significant difference ( P vitamin experienced approximately 30 % fewer total days of disability ( confined to the house or off work ) than those receiving the placebo , and this difference was statistically highly significant ( P reduction in disability appeared to be due to a lower incidence of constitutional symptoms such as chills and severe malaise , and was seen in all types of acute illness , including those which did not involve the upper respiratory tract",
"The risk of upper respiratory infections ( URIs ) is increased in people who are under heavy physical stress , including recreational and competitive swimmers . Additional treatment options are needed , especially in the younger age group . The aim of this study was to determine whether 1 g/day vitamin C supplementation affects the rate , length , or severity of URIs in adolescent swimmers . We carried out a r and omized , double-blind , placebo-controlled trial during three winter months , among 39 competitive young swimmers ( mean age 13.8 ± 1.6 years ) in Jerusalem , Israel . Vitamin C had no effect on the incidence of URIs ( rate ratio = 1.01 ; 95 % confidence interval ( CI ) = 0.70–1.46 ) . The duration of respiratory infections was 22 % shorter in vitamin C group , but the difference was not statistically significant . However , we found a significant interaction between vitamin C effect and sex , so that vitamin C shortened the duration of infections in male swimmers by 47 % ( 95 % CI : −80 % to −14 % ) , but had no effect on female swimmers ( difference in duration : + 17 % ; 95 % CI : −38 % to + 71 % ) . The effect of vitamin C on the severity of URIs was also different between male and female swimmers , so that vitamin C was beneficial for males , but not for females . Our study indicates that vitamin C does not affect the rate of respiratory infections in competitive swimmers . Nevertheless , we found that vitamin C decreased the duration and severity of respiratory infections in male swimmers , but not in females . This finding warrants further research",
" Between December 1972 and February 1973 , 2349 volunteers participated in a double-blind trial to assess the effect of large doses of vitamin C on the incidence and severity of winter illness . In addition , records were kept but no tablets taken during March . Subjects were r and omly allocated to eight treatment regimens : three prophylactic-only ( daily dose 0.25 , 1 or 2 g ) , two therapeutic-only ( 4 or 8 g on the first day of illness ) , one combination ( 1 g daily and 4 g on the first day of illness ) , and two all-placebo . None of the groups receiving vitamin C showed a difference in sickness experience that was statistically significant from that of the placebo groups , but the results obtained were compatible with an effect of small magnitude from both the prophylactic and therapeutic regimens , and an effect of somewhat greater magnitude from the combination regimen . The combination regimen was associated more with a reduction in severity than frequency of illness , although the extra dosage was limited to the first day of illness . In spite of the eightfold range in daily dose , the three prophylactic-only regimens showed no evidence of a dose-related effect , but the 8 g therapeutic dose was associated with less illness than the 4 g therapeutic dose . There was no evidence of side effects from the 1 and 2 g prophylactic doses of vitamin C , and no evidence of a rebound increase in illness during the month following withdrawal of the daily vitamin supplements . On the basis of this and other studies it is suggested that the optimum daily dose of vitamin C is less than 250 mg , except possibly at the time of acute illness , when a larger daily intake may be beneficial",
"After their r and om -llocation to one of three treatment aroups , 622 volunteers received either vitamin C or placebo in a maintenance dose of 500 mg once weekly and a therapeutic dose of 1500 mg daily on the 1st day and 1000 mg on the next 4 days of any illness . Two forms of vitamin C were employed : a sustained-release capsule containing ascorbic acid and a regular tabet containing a mixture of sodium and calcium ascorbate . In the 448 subjects who completed an average of 15 weeks in the study of total of 635 episodes of illness were recroded . Respiratory symptoms were recorded on at least 1 day in 92 per cent of these episodes . There were no consistent or significant differences in the sickness experience of the subjects receiving the sustained-release vitamin capsules compared to those receiving the vitamin tablets , but subjects in both vitamin groups experienced less severe illness than subjects in the placebo group , with approximately 25 per cent fewer days spent indoors because of the illness ( P smaller than 0.05 ) . These results are compatible with the belief that supplementary vitamin C can reduce the burden of winter illness , but the intake need not be as high as has sometimes been cl aim ed"
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4117326e-06ff-11f0-808a-c43d1ab1c353
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There is no consensus on the most effective operation for primary Dupuytren ’s contracture . This systematic review evaluates the reported rates of recurrence and complications , as well as the strength of evidence , for individual procedures . The PubMed and EMBASE data bases were search ed for papers in English containing ‘ Dupuytren ’ in the citation . The initial search produced 2155 references , of which 69 papers met the study inclusion criteria . There was wide disparity in scoring systems , definition of recurrence and recording of complications . Follow-up ranged from 3 weeks to 13 years , and recurrence from 0 to 71 % . There are only three Level I studies comparing surgical techniques for the treatment of primary Dupuytren ’s contracture , and the evidence does not support one procedure above another , other than to show a particularly high recurrence rate after needle fasciotomy . We propose a minimum data set for future studies
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"We studied the influence of the type of skin incision on the recurrence rate following fasciectomy for Dupuytren ’s disease . Patients were r and omized to a longitudinal incision closed with Z-plasties or a modified Bruner incision closed by Y – V plasties . Follow-up was for at least 2 years or until a recurrence was noted . We found no statistical difference in recurrence rate between patients having these two skin incisions and closures ",
"Tension in the palmar fascia has been proposed as a factor causing Dupuytren ’s disease . If tension does stimulate the growth of new Dupuytren ’s tissue , relieving longitudinal tension should reduce the recurrence rate following surgery . Thirty patients with palmar Dupuytren ’s contracture of a single ray that affected only the metacarpophalangeal joint were divided into two groups . Both groups had a fasciotomy : one group through a transverse incision that was closed directly and the other through a longitudinal incision with Z-plasty closure . Half the patients ( seven of 14 ) who had direct closure had recurrence at 2 years as compared to two of the 13 in the Z-plasty group . The trial was stopped at the interim analysis stage due to the high recurrence rate in the first group . These results are consistent with the tension hypothesis for the aetiology of Dupuytren ’s disease",
"PURPOSE The dem and for percutaneous needle fasciotomy ( PNF ) as treatment for Dupuytren 's disease is increasing because of its limited invasiveness , good outcome , limited number of complications , quick recovery , and overall patient satisfaction . This r and omized controlled trial was design ed to test whether these short-term expectations are sound by comparing this treatment with limited fasciectomy ( LF ) with regard to these aspects . METHODS We treated 166 rays : 88 by PNF and 78 by LF . Total passive extension deficit ( TPED ) improvement at 1 week and at 6 weeks were the primary outcome parameters ; patient satisfaction , h and -function recovery , and complication rate were secondary outcome parameters . We used the Disabilities of the Arm , Shoulder , and H and question naire to measure disabilities of the upper extremity before and after treatment and all adverse effects and complications were recorded . RESULTS Overall TPED improvement was best at 6 weeks . In the PNF group TPED improved by 63 % versus 79 % in the LF group ; this difference was statistically significant . Results at the proximal interphalangeal joint were worse than those at the metacarpophalangeal and distal interphalangeal joints for both the PNF and LF groups . The rays classified before surgery as Tubiana stages I and II showed no difference between these treatments , but for rays higher than stage II LF clearly was superior to PNF as a treatment modality . The rate of major complications in the LF group was 5 % versus 0 % in the PNF group . Patient satisfaction was almost equal but direct h and function after treatment was considered better in the PNF group , as was the degree of discomfort that patients experienced . This was underscored by the Disabilities of the Arm , Shoulder , and H and scores in the PNF group , which were significantly lower than those in the LF group at all time points measured . CONCLUSIONS In the short term and in cases with a TPED of 90 degrees or less PNF is a good treatment alternative to LF for treatment of Dupuytren 's disease . TYPE OF STUDY /LEVEL OF EVIDENCE Therapeutic , Level",
"Dupuytren ’s disease is an affliction of the palmar fascia . Selective fasciectomy is recommended once contracture has occurred . Alternatives for wound closure include tissue rearrangement , the open palm technique , and full-thickness skin grafting . In this prospect i ve study , a new “ synthesis ” technique was used to treat a cohort of patients with advanced Dupuytren ’s disease . The results were then compared with those of a second cohort of patients who underwent the open palm technique . Thirty consecutive patients were selected . Ten patients ( nine men and one woman ; average age , 67 years ) underwent the open palm technique , and 20 patients ( 18 men and two women ; average age , 70 years ) underwent the synthesis method . Follow-up was 3.5 years for the open palm group and 2.7 years for the synthesis group . All patients in both groups improved with respect to motion , function , appearance , and satisfaction . Objective ly , for the open palm technique , metacarpophalangeal joint contracture decreased from 50 degrees to 0 degrees , and proximal interphalangeal joint contracture decreased from 40 degrees to 6 degrees . Using the synthesis method , metacarpophalangeal joint contracture decreased from 57 degrees to 0 degrees , and proximal interphalangeal joint contracture decreased from 58 degrees to 10 degrees . The Disabilities of the Arm , Shoulder , and H and Test scores decreased from 37 to 30 in both groups . There were no significant differences between groups in these parameters . The two significant intergroup differences were healing time ( 40 days for the open palm technique versus 28 days for the synthesis method ) and recurrence rate ( 50 percent for open palm versus 0 percent for synthesis ) . The synthesis technique combines with success the best features of current methods for the surgical treatment of advanced Dupuytren ’s disease"
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411732aa-06ff-11f0-808a-c43d1ab1c353
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Atrial fibrillation ( AF ) is the most common arrhythmia in the elderly , currently affecting more than 2.7 million Americans ( 1 ) , with a projected prevalence of 5.6 to 12.1 million by 2050 ( 2 , 3 ) . Patients with AF have not only a 4- to 5-fold increase in the risk for stroke ( 4 ) but also larger brain infa rct ions and worse poststroke outcomes than patients without AF ( 57 ) . A recent meta- analysis demonstrated that AF is associated with a 40 % increase in the risk for cognitive impairment ( relative risk [ RR ] , 1.40 [ 95 % CI , 1.19 to 1.64 ] ) ( 8) . This association was independent of a history of symptomatic stroke ( RR , 1.34 [ CI , 1.13 to 1.58 ] ) ( 8) and other comorbid conditions , such as advanced age , hypertension , heart failure , and diabetes ( 9 , 10 ) . These findings highlight the elusiveness of the mechanisms underlying this association and suggest pathways other than symptomatic stroke and shared risk factors listed previously as the underlying cause of this association . One such mechanism may be silent cerebral infa rct ions ( SCIs ) . Several studies showed a significant association between AF and SCIs in patients without a history of clinical ly overt stroke ( 11 , 12 ) ; however , the few studies that attempted to reproduce similar results did not demonstrate an association ( 13 , 14 ) . There is a significant variability in the reported prevalence of SCIs in patients with AF ( 11 , 12 ) . One source of this heterogeneity may lie in the different methods of diagnosing SCIs . Whereas earlier studies used autopsy ( 15 , 16 ) or computed tomography ( CT ) scans ( 1719 ) to identify SCIs , recent studies have used magnetic resonance imaging ( MRI ) ( 12 , 13 ) , a more sensitive method , to detect such lesions . It is critical to underst and the association between AF and SCIs , not only because it may be a mediating factor in the link between AF and cognitive impairment but also because SCIs may predict future symptomatic strokes and death ( 2023 ) . No study has attempted to gather all of the available data in the literature on the association between AF and SCIs and on the prevalence of SCIs in patients with AF . Therefore , we performed a systematic review and meta- analysis of the literature to estimate the association between AF and SCIs and the prevalence of SCIs in patients with AF and no history of symptomatic stroke . Methods An internal study protocol was developed at the Cardiac Arrhythmia Service ( Boston , Massachusetts ) to perform this review ; the protocol was not registered in any data base . Data Sources Five leading bibliographic data bases of biomedical science ( MEDLINE [ Ovid interface ] , PsycINFO , Cochrane Library [ Ovid SP ] , CINAHL , and EMBASE ) were search ed electronically from their inception to 8 May 2014 , using text and explosion of medical subject headings ( Supplement ) . One of the investigators design ed the search strategies with the help of a trained librarian . In addition , bibliographies of pertinent articles as well as review papers were manually search ed . No language restriction was applied . Authors of the included studies were contacted when required data were missing or ambiguous . Supplement . Literature Search Through 8 May 2014 Study Selection Prospect i ve and non prospect i ve studies reporting the prevalence or incidence of SCIs in patients with AF , as well as prospect i ve and non prospect i ve studies in which a risk estimate for the association between AF and SCIs was reported or could be calculated , were included in this meta- analysis . Magnetic resonance imaging studies were only included if they acknowledged the exclusion of leukoaraiosis from their analyses , used diffusion-weighted images , or used either hypodensity on fluid-attenuated inversion recovery images or prominent hypodensity on T1-weighted images as an additional criterion to separate leukoaraiosis from SCIs . Exclusion criteria included inappropriate study design ( such as review s , editorials , letters , case series , case reports , and conference proceedings ) ; studies evaluating SCIs after a procedure , such as catheter ablation , coronary artery bypass graft surgery , or cardioversion , in patients with AF ; studies with conflicting and inconsistent data in which discrepancies between text and tables could not be resolved by contacting authors or consensus ; studies of patients with prosthetic heart valves ; studies restricted to patients with mitral stenosis or rheumatic valve disease ; studies using transcranial Doppler sonography or electroencephalography for diagnosis of SCIs ; and studies of patients with acute stroke or a history of symptomatic stroke . Data Extraction Following MOOSE ( Meta- analysis of Observational Studies in Epidemiology ) guidelines ( 24 ) , studies were initially screened on the basis of titles and abstract s. The full texts of potentially relevant papers were later review ed . The reference lists of the review papers and studies that met the inclusion criteria were manually search ed . Data from individual studies were extracted by 2 independent observers . Discrepancies were resolved by consensus or a third review er . The data extraction sheet included the first author ; year ; study design ( prospect i ve vs. non prospect i ve ) ; study setting and comparison groups ; follow-up period ( when applicable ) ; population characteristics ( age ; sex ; country ; comorbid conditions , particularly history of symptomatic stroke ; and medication , particularly anticoagulants ) ; inclusion and exclusion criteria ; AF type ( paroxysmal vs. persistent ) ; and methods of AF ascertainment ( electrocardiography vs. others ) . The data extraction sheet also included the method of outcome ascertainment ( CT , MRI , or autopsy ) ; CT , MRI , or autopsy specifications ( such as section thickness or number and thickness of gaps between the slices ) ; categories of SCI size ; definition of SCI ; total sample size ; number of patients with and without AF ; number of patients with SCIs within each group ; type of RR estimate ( odds ratio [ OR ] , risk ratio , or hazard ratio ) ; point estimate and 95 % CI ; list of variables in the multivariate model ; and level of adjustment . We considered adjustment for confounding either at the study design stage ( such as restriction and matching ) or at the analyses stage ( such as stratification or multivariate analyses ) to be acceptable . Studies that used an acceptable method to control for at least 5 of the following 6 variables were considered to be at minimal risk of confounding bias : age , sex , hypertension , hyperlipidemia , diabetes mellitus , and significant carotid stenosis . Studies that did not control for 2 or more of these variables were considered at moderate risk of confounding bias , and those with no adjustment for any of the variables were considered at high risk of confounding bias and were excluded from analysis of pooled OR . Quality Assessment Because there are no st and ard criteria to assess the quality of observational studies , we used an adaptation of 2 published checklists ( 25 , 26 ) and criteria that were applicable and relevant to the eligible studies . Risk for misclassification of AF and SCIs , as well as risk of confounding and selection bias , were assessed using 15 questions ( Appendix Table 1 ) . Not all of the quality criteria were applicable to each study ; therefore , to make valid comparisons among studies , we used the ratio of estimated quality score to maximum possible score ( Appendix Table 2 ) . The total score was calculated and a sensitivity analysis was performed , including only studies that met at least 70 % of the total possible quality score . Appendix Table 1 . Fifteen Questions to Assess the Quality of Included Studies Appendix Table 2 . Assessing the Quality of Included Studies Using 15 Criteria Data Synthesis and Analysis Silent cerebral infa rct ions were broadly defined as evidence of brain infa rct ions on imaging or autopsy with no attributable clinical symptoms ( such as neurologic deficits ) . When possible , SCIs were stratified according to their location as cortical versus noncortical . Cortical infa rct ions were defined as infa rct ions in the cerebral cortex with or without extension into the subcortical white matter . In the presence of heterogeneity , we used r and om-effects models and the profile likelihood method ( 27 ) to perform the meta- analysis of the association between AF and SCIs . In the absence of heterogeneity , results from fixed-effects models were reported . Forest plots were used to display and summarize the association between AF and SCIs according to SCI diagnosis methods . The Q statistic was used to test for heterogeneity . The degree of heterogeneity was quantified by I 2 statistics with an I 2 value of 30 % to 60 % representing a moderate level of heterogeneity ( 28 ) . We estimated the prevalence of SCIs in patients with AF for each study using binomial distribution . The PROC GLIMMIX procedure in SAS , version 9.1 , was used to estimate pooled prevalence of SCIs in patients with AF according to the method of SCI diagnosis . PROC GLIMMIX is able to fit generalized linear mixed models to correlated data with nonconstant variability where the response is not necessarily normally distributed ( response distribution for the prevalence was specified as binomial ) . Stata/IC , version 12 , was used to perform the remainder of the analyses . The significance level was defined as a P value less than 0.05 for all analyses . Role of the Funding Source This review was funded by the Deane Institute for Integrative Research in Atrial Fibrillation and Stroke , Massachusetts General Hospital . The funding source had no role in the design or conduct of the study ; collection or analysis of the data ; or the decision to su bmi t the manuscript for publication . Results Of 1723 titles and abstract s , 105 papers met the criteria for full-text screening . One German ( 29 ) and 2 Japanese ( 30 , 31 ) articles were translated into English . Sixteen papers from the electronic search and 1 from the manual search met the inclusion criteria ( Appendix Figure ) . The prevalence of SCIs was extracted or calculated from 17 studies ( 9
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"BACKGROUND Silent brain infa rcts are frequently seen on magnetic resonance imaging ( MRI ) in healthy elderly people and may be associated with dementia and cognitive decline . METHODS We studied the association between silent brain infa rcts and the risk of dementia and cognitive decline in 1015 participants of the prospect i ve , population -based Rotterdam Scan Study , who were 60 to 90 years of age and free of dementia and stroke at base line . Participants underwent neuropsychological testing and cerebral MRI at base line in 1995 to 1996 and again in 1999 to 2000 and were monitored for dementia throughout the study period . We performed Cox proportional-hazards and multiple linear-regression analyses , adjusted for age , sex , and level of education and for the presence or absence of subcortical atrophy and white-matter lesions . RESULTS During 3697 person-years of follow-up ( mean per person , 3.6 years ) , dementia developed in 30 of the 1015 participants . The presence of silent brain infa rcts at base line more than doubled the risk of dementia ( hazard ratio , 2.26 ; 95 percent confidence interval , 1.09 to 4.70 ) . The presence of silent brain infa rcts on the base-line MRI was associated with worse performance on neuropsychological tests and a steeper decline in global cognitive function . Silent thalamic infa rcts were associated with a decline in memory performance , and nonthalamic infa rcts with a decline in psychomotor speed . When participants with silent brain infa rcts at base line were subdivided into those with and those without additional infa rcts at follow-up , the decline in cognitive function was restricted to those with additional silent infa rcts . CONCLUSIONS Elderly people with silent brain infa rcts have an increased risk of dementia and a steeper decline in cognitive function than those without such lesions",
"Silent brain infa rct ion ( SBI ) and white matter lesions ( periventricular hyperintensity [ PVH ] and subcortical white matter lesions [ SWML ] are detected in both stroke patients and normal elderly persons . We prospect ively examined the association between these lesions and the risk of subsequent stroke and mortality in neurologically normal adults . Magnetic resonance imaging scans were performed in 2,684 neurologically normal subjects with no history of stroke ( mean age , 58 + /- 7 years old at entry ) who underwent our health screening of the brain . After the brain screening , we obtained information about clinical stroke onset and death using a question naire sent annually to all subjects . When a subject suffered from medical events , we confirmed the detailed information in a telephone interview and by asking the attending physician . SBI was defined as a focal T2-hyperintensity and T1-hypointensity lesion > 3 mm . PVH and SWML were grade d according to their severity . The average follow-up period was 6.3 years . Stroke occurred in 102 subjects ( 3.8 % ) , and 93 subjects died during follow-up . The incidence of clinical stroke was significantly higher in the subjects with SBI than in those without SBI . Marked PVH and marked SWML independently increased the risk of stroke ( for SBI , stroke risk factor-adjusted odds ratio [ OR ] = 3.66 , 95 % confidence interval [ CI ] = 2.28 - 5.89 ; for marked PVH , stroke risk factor-adjusted OR = 2.08 , 95 % CI = 1.04 - 4.17 ; for marked SWML , stroke risk factor-adjusted OR = 2.73 , 95 % CI = 1.32 - 5.63 ) . Regarding mortality , SBI and marked PVH increased the risk of death ( for SBI , stroke risk factor-adjusted OR = 1.95 , 95 % CI = 1.16 - 3.29 ; for PVH , stroke risk factor-adjusted OR = 4.01 , 95 % CI = 1.91 - 8.45 ) . Death attributable to stroke occurred more frequently in those subjects with SBI , marked PVH , and marked SWML . We conclude that SBI , marked PVH , and marked SWML are important risk factors for clinical stroke and that SBI and marked PVH also increase the risk of mortality",
"Background and Purpose — Silent brain infa rcts and white matter lesions are associated with an increased risk of subsequent stroke in minor stroke patients . In healthy elderly people , silent brain infa rcts and white matter lesions are common , but little is known about their relevance . We examined the risk of stroke associated with these lesions in the general population . Methods — The Rotterdam Scan Study is a population -based prospect i ve cohort study among 1077 elderly people . The presence of silent brain infa rcts and white matter lesions was scored on cerebral MRI scans obtained from 1995 to 1996 . Participants were followed for stroke for on average 4.2 years . We estimated the risk of stroke in relation to presence of brain lesions with Cox proportional hazards regression analysis . Results — Fifty-seven participants ( 6 % ) experienced a stroke during follow-up . Participants with silent brain infa rcts had a 5 times higher stroke incidence than those without . The presence of silent brain infa rcts increased the risk of stroke > 3-fold , independently of other stroke risk factors ( adjusted hazard ratio 3.9 , 95 % CI 2.3 to 6.8 ) . People in the upper tertile of the white matter lesion distribution had an increased stroke risk compared with those in the lowest tertile ( adjusted hazard ratio for periventricular lesions 4.7 , 95 % CI 2.0 to 11.2 and for subcortical lesions 3.6 , 95 % CI 1.4 to 9.2 ) . Silent brain infa rcts and severe white matter lesions increased the stroke risk independently of each other . Conclusion — Elderly people with silent brain infa rcts and white matter lesions are at a strongly increased risk of stroke , which could not be explained by the major stroke risk factors",
"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",
"PURPOSE Patients ( pts . ) with atrial fibrillation ( AF ) and atrial thrombi are known to have an increased risk for cerebral embolism . However , little is known about the clinical course of atrial thrombi and the incidence of cerebral embolism in those patients during anticoagulation therapy . The high sensitivity of MR imaging ( MRI ) including diffusion-weighted imaging ( DWI ) suggests that this technique could provide an improved estimate of cerebral embolism associated with the presence of left atrial thrombi . The aims of this prospect i ve study were to evaluate 1 ) the prevalence of clinical ly silent and apparent cerebral embolism in pts . with newly diagnosed AF and atrial thrombi using MRI/DWI , 2 ) the long-term fate of atrial thrombi under continues anticoagulation therapy and 3 ) the incidence of cerebral embolism during a follow-up period of 12 months with continuous anticoagulation therapy . MATERIAL S AND METHODS The study group consisted of 32 pts . with 1 ) newly diagnosed AF and evidence of left atrial ( LA ) thrombi detected by TEE and 2 ) a new start of anticoagulation therapy [ International Normalized Ratio ( INR ) 2.0 - 3.0 ] . 19 pts . with 1 ) newly diagnosed AF and no evidence of atrial thrombi and 2 ) an equivalent anticoagulation regimen served as the control group . In both groups a ) MRI/DWI studies of the brain ( weeks 0 , 4 , 8 , 12 , 20 , 28 , 36 , 44 , and 52 ) , b ) transesophageal echocardiographic studies ( TEE ) for assessment of LA-Thrombi ( weeks 0 and 52 ) and c ) clinical neurological assessment s ( weeks 0 , 20 and 52 ) were performed . RESULTS In the study group ( AF and LA-Thrombi ) 11 out of 32 pts . ( 34 % ) displayed signs of acute ( n = 8) or chronic ( n = 3 ) cerebral embolism in the initial MRI studies . In 4 out of 32 pts . ( 13 % ) , MRI/DWI depicted new or additional cerebral emboli ( n = 12 ) during the follow-up period despite continuous anticoagulation therapy . 2 ( n = 2/4 ; 50 % ) of these patients had clinical ly apparent neurological deficits . In the control group 1 out of 19 pts . ( 5 % ) showed evidence of chronic cerebral embolism as assessed by MRI/DWI at the beginning of the study ( week 0 ) . No embolic cerebral lesions were detected during the 12-month follow-up . Within 12 months only 63 % ( n = 20/32 ) of LA thrombi in the study group resolved completely under anticoagulation . CONCLUSION 1 . The incidence of clinical ly inapparent cerebral emboli in pts . with newly diagnosed AF and atrial thrombi is much higher than the incidence of clinical ly apparent emboli and has been underestimated in the past . 2 . New cerebral embolism may occur even with continued effective anticoagulation therapy in 13 % of pts . 3 . Only 63 % of atrial thrombi resolve completely within 12 months under anticoagulation therapy",
"OBJECTIVES To determine whether atrial fibrillation ( AF ) is associated with risk of incident dementia or Alzheimer 's disease ( AD ) , beyond its effect on stroke . DESIGN Prospect i ve cohort study . SETTING An integrated healthcare delivery system . PARTICIPANTS A population -based sample of 3,045 community-dwelling adults aged 65 and older without dementia or clinical stroke followed from 1994 to 2008 . MEASUREMENTS AF was identified from health plan electronic data using International Classification of Diseases , Ninth Revision , codes from inpatient and outpatient encounters . Covariates came from self-report , study measures , and health plan data . Participants were screened every 2 years using the Cognitive Abilities Screening Instrument ( range 0 - 100 ) , with detailed neuropsychological and clinical assessment of those scoring less than 86 . A multidisciplinary consensus committee determined diagnoses of all-cause dementia and possible or probable AD using st and ard research criteria . RESULTS AF was present in 132 ( 4.3 % ) participants at baseline and was diagnosed in 370 ( 12.2 % ) more over a mean of 6.8 years of follow-up ; 572 participants ( 18.8 % ) developed dementia ( 449 with AD ) . The adjusted hazard ratio associated with AF was 1.38 ( 95 % confidence interval (CI)=1.10 - 1.73 ) for all-cause dementia and 1.50 ( 95 % CI=1.16 - 1.94 ) for possible or probable AD . Results were similar for participants with and without clinical ly recognized stroke during follow-up and in sensitivity analyses examining only probable AD . CONCLUSION AF is associated with higher risk of developing AD and dementia . Future studies should examine whether specific treatments , including optimal anticoagulation , can decrease this risk",
"BACKGROUND Atrial fibrillation ( AF ) is a cardiac arrhythmia that does not infrequently induce ischemic strokes ; however , little research has been reported on focal cerebral microangiopathic lesions in patients with AF . Recently cerebral microbleeds ( CMBs ) have been noticed for their potential implication in cerebral small vessel disease . Therefore , we had 2 goals in the present study : ( 1 ) to compare the prevalence of CMBs in patients with AF with that in patients without AF , and ( 2 ) to prove that CMBs could be a clinical predictive factor for the development of future cerebral microangiopathy in patients with AF without a history of symptomatic cerebral infa rct ion in a prospect i ve manner . METHODS We performed yearly brain magnetic resonance imaging ( MRI ) assessment s for a maximum of 5 years in 131 patients with AF and 112 control patients . Seventy-seven patients with AF underwent more than 3 yearly MRI scans . RESULTS The Kaplan-Meier curve showed that the development of an asymptomatic cerebral infa rct ion ( ACI ) was associated with the baseline presence of a CMB ( P=.004 ) . A multivariate Cox regression analysis revealed that the CMBs at baseline were significantly associated with an increment in not only the occurrence of ACIs ( hazard ratio [ HR ] , 5.414 ; 95 % confidence interval [ CI ] , 1.03 - 28.43 ; P=.046 ) but also in the consecutive development of CMBs ( HR , 6.274 ; 95 % CI , 1.43 - 27.56 ; P=.015 ) . CONCLUSIONS Patients with AF had a significantly higher prevalence of CMBs . The presence of CMBs in the baseline MRI may predict the consequent onset of an ACI and increase in CMBs in patients with AF",
"BACKGROUND The aging population has result ed in more patients living with cardiovascular disease , such as atrial fibrillation ( AF ) . Recent focus has been placed on underst and ing the long-term consequences of chronic cardiovascular disease , such as a potential increased risk of dementia . OBJECTIVE This study sought to determine whether there is an association between AF and dementia and whether their coexistence is an independent marker of risk . METHODS A total of 37,025 consecutive patients from the large ongoing prospect i ve Intermountain Heart Collaborative Study data base were evaluated and followed up for a mean of 5 years for the development of AF and dementia . Dementia was sub-typed into vascular ( VD ) , senile ( SD ) , Alzheimer 's ( AD ) , and nonspecified ( ND ) . RESULTS Of the 37,025 patients with a mean age of 60.6 + /- 17.9 years , 10,161 ( 27 % ) developed AF and 1,535 ( 4.1 % ) developed dementia ( 179 VD , 321 SD , 347 AD , 688 ND ) during the 5-year follow-up . Patients with dementia were older and had higher rates of hypertension , coronary artery disease , renal failure , heart failure , and prior strokes . In age-based analysis , AF independently was significantly associated with all dementia types . The highest risk was in the younger group ( ) . After dementia diagnosis , the presence of AF was associated with a marked increased risk of mortality ( VD : hazard ratio [ HR ] = 1.38 , P = .01 ; SD : HR = 1.41 , P = .001 ; AD : HR = 1.45 ; ND : HR = 1.38 , P forms of dementia . Although dementia is strongly associated with aging , the highest risk of AD was in the younger group , in support of the observed association . The presence of AF also identified dementia patients at high risk of death",
"We performed unenhanced computed tomographic scans on 141 asymptomatic patients with nonvalvular atrial fibrillation . Thirty-six patients ( 26 % ) had hypodense areas consistent with cerebral infa rct ion . The majority of these were small deep infa rcts , seen in 29 patients ( 21 % ) , but 13 patients ( 9 % ) had cortical or large deep infa rct ions . Twelve patients had more than one infa rct on computed tomographic scan . Increasing age and increased left atrial diameter were the only clinical features associated with asymptomatic infa rct ion . Patients older than 65 years with a left atrial diameter greater than 5.0 cm ( n = 23 ) had a 52 % prevalence of asymptomatic infa rct ion . Patients younger than 65 years with a left atrial diameter less than 5.0 cm ( n = 38 ) had an 11 % prevalence of silent infa rct ion . Patients with only one of these risk factors ( n = 72 ) had a 24 % prevalence of silent infa rct ion . Infa rct ion was more common in those with chronic ( 34 % ) as opposed to intermittent ( 22 % ) nonvalvular atrial fibrillation , but this difference was not significant . Hypertension , diabetes , duration of atrial fibrillation , congestive heart failure , history of myocardial infa rct ion , and echocardiographic evidence of left ventricular dysfunction were not associated with asymptomatic infa rct ion . A history of hypertension was present in only 35 % of our patients with small-deep asymptomatic infa rct ion , similar to the percentage in patients without stroke . Asymptomatic cerebral infa rct ion is common in nonvalvular atrial fibrillation . The association with enlarged left atria and the lack of correlation with major cerebrovascular risk factors suggests a cardioembolic mechanism . Further study is needed to determine the functional and prognostic significance of these strokes",
"BACKGROUND Cerebral infa rct ion in patients with atrial fibrillation may vary from being clinical ly silent to catastrophic . The prevalence of silent cerebral infa rct ion and its effect as a risk factor for symptomatic stroke are important considerations for the evaluation of patients with atrial fibrillation . METHODS AND RESULTS This Veterans Affairs cooperative study was a double-blind controlled trial design ed primarily to determine the efficacy of warfarin for the prevention of stroke in neurologically normal patients with nonrheumatic atrial fibrillation . It also was design ed to evaluate patients with silent cerebral infa rct ion . Computed tomography scans of the head were performed at entry , at the time of any subsequent stroke , and at termination of follow-up on all patients who completed the study without a neurological event . Of 516 evaluable scans performed at entry , 76 ( 14.7 % ) had evidence of one or more silent cerebral infa rcts . Age ( P = .011 ) , a history of hypertension ( P = .003 ) , active angina ( P = .012 ) , and elevated mean systolic blood pressure ( P Silent cerebral infa rct ion occurred during the study at rates of 1.01 % and 1.57 % per year for the placebo and warfarin treatment groups , respectively ( NS ) . Silent cerebral infa rct ion at entry was not an independent predictor of later symptomatic stroke , but active angina was a significant predictor ; 15 % of the placebo-assigned patients with angina developed a stroke compared with 5 % of the placebo-assigned patients without angina . CONCLUSIONS Silent cerebral infa rct ion is frequently seen in asymptomatic patients with atrial fibrillation . Age , history of hypertension , active angina , and elevated mean systolic blood pressure were associated with silent infa rct ion at entry . The sample size was too small to determine whether warfarin had an effect on the incidence of silent infa rct ion during the trial . Active angina at baseline was the only significant independent predictor for the later development of symptomatic stroke"
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Clinical practice guidelines state that the tissue source of low back pain can not be specified in the majority of patients . However , there has been no systematic review of the accuracy of diagnostic tests used to identify the source of low back pain . The aim of this systematic review was therefore to determine the diagnostic accuracy of tests available to clinicians to identify the disc , facet joint or sacroiliac joint ( SIJ ) as the source of low back pain . MEDLINE , EMBASE and CINAHL were search ed up to February 2006 with citation tracking of eligible studies . Eligible studies compared index tests with an appropriate reference test ( discography , facet joint or SIJ blocks or medial branch blocks ) in patients with low back pain . Positive likelihood ratios ( + LR ) > 2 or negative likelihood ratios ( -LR ) Forty-one studies of moderate quality were included ; 28 investigated the disc , 8 the facet joint and 7 the SIJ . Various features observed on MRI ( high intensity zone , endplate changes and disc degeneration ) produced informative + LR ( > 2 ) in the majority of studies increasing the probability of the disc being the low back pain source . However , heterogeneity of the data prevented pooling . + LR ranged from 1.5 to 5.9 , 1.6 to 4.0 , and 0.6 to 5.9 for high intensity zone , disc degeneration and endplate changes , respectively . Central isation was the only clinical feature found to increase the likelihood of the disc as the source of pain : + LR = 2.8 ( 95%CI 1.4–5.3 ) . Absence of degeneration on MRI was the only test found to reduce the likelihood of the disc as the source of pain : −LR = 0.21 ( 95%CI 0.12–0.35 ) . While single manual tests of the SIJ were uninformative , their use in combination was informative with + LR of 3.2 ( 95%CI 2.3–4.4 ) and −LR of 0.29 ( 95%CI 0.12–0.35 ) . None of the tests for facet joint pain were found to be informative . The results of this review demonstrate that tests do exist that change the probability of the disc or SIJ ( but not the facet joint ) as the source of low back pain . However , the changes in probability are usually small and at best moderate . The usefulness of these tests in clinical practice , particularly for guiding treatment selection , remains unclear
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"Background Only controlled blocks are capable of confirming the zygapophysial joints ( ZJ ) as the pain generator in LBP patients . However , previous workers have found that a cluster of clinical signs ( \" Revel 's criteria \") , may be valuable in predicting the results of an initial screening ZJ block . It was suggested that these clinical findings are unsuitable for diagnosis , but may be of value in selecting patients for diagnostic blocks of the lumbar ZJ 's . To constitute evidence in favour of a clinical management strategy , these results need confirmation . This study evaluates the utility of ' Revel 's criteria ' as a screening tool for selection of chronic low back pain patients for controlled ZJ diagnostic blocks . Methods This study utilized a prospect i ve blinded concurrent reference st and ard related validity design . Consecutive chronic LBP patients completed pain drawings , psychosocial distress and disability question naires , received a clinical examination and lumbar zygapophysial blocks . Two reference st and ards were evaluated simultaneously : 1 . 75 % reduction of pain on a visual analogue scale ( replication of previous work ) , and 2 . abolition of the dominant or primary pain . Using \" Revel 's criteria \" as predictors , logistic regression analyses were used to test the model . Estimates of sensitivity , specificity , predictive values and likelihood ratios for selected variables were calculated for the two proposed clinical strategies . Results Earlier results were not replicated . Sensitivity of \" Revel 's criteria \" was low sensitivity ( specificity high ( approximately 90 % ) . Absence of pain with cough or sneeze just reached significance ( p = 0.05 ) within one model . Conclusions \" Revel 's criteria \" are unsuitable as a clinical screening test to select chronic LBP patients for initial ZJ blocks . However , the criteria may have use in identifying a small subset ( 11 % ) of patients likely to respond to the initial block ( specificity 93 % )",
"Study Design This prospect i ve study evaluated the diagnostic utility of historically accepted sacroiliac joint tests . A multidisciplinary expert panel recommended 12 of the “ best ” sacroiliac joint tests to be evaluated against a criterion st and ard of unequivocal pain relief after an intra‐articular injection of local anesthetic into the sacroiliac joint . Objectives To identify a single sacroiliac joint test or ensemble of tests that are sufficiently useful in diagnosing sacroiliac joint disorders to be clinical ly valuable . Summary of Background Data No previous research has been done to evaluate any physical test of sacroiliac joint pain against an accepted criterion st and ard . Methods Historical data was obtained , and the 12 tests were performed by two examiners on 85 patients who subsequently underwent sacroiliac joint blocks . Ninety percent or more relief was considered a positive response , and less then 90 % relief was considered a negative response . Results There were 45 positive and 40 negative responses . No historical feature , none of the 12 sacroiliac joint tests , and no ensemble of these 12 tests demonstrated worthwhile diagnostic value . Conclusion Sacroiliac joint pain is resistant to identification by the historical and physical examination data from tests evaluated in this study",
"Abstract A prospect i ve study was performed to compare the results of quantitative radionuclide bone scanning with those of sacroiliac joint anesthetic block in patients with unilateral low back pain . Thirty-four subjects , forming the control group , underwent quantitative radionuclide bone scanning of the sacroiliac joints . The normal values in sacroiliac uptake difference were taken to be between –1.7 % and + 6.2 % . Thirty-two patients with chronic unilateral low back pain underwent sacroiliac bone scanning and sacroiliac joint block . Six of the seven patients with increased uptake > 6.2 % on the painful side had at least 75 % pain reduction in response to the block . The sensitivity , specificity , and positive and negative predictive values of the quantitative bone scanning in the unilateral mechanical sacroiliac joint syndrome were 46.1 % , 89.5 % , 85.7 % , and 72 % , respectively",
"BACKGROUND Only controlled intra-articular zygapophyseal joint ( ZJ ) injections or medial branch blocks can diagnose ZJ-mediated low back pain . The low prevalence of ZJ pain implies that identification of clinical predictors of a positive response to a screening block is needed . PURPOSE To estimate the predictive power of clinical findings in relation to pain reduction after screening ZJ blocks . STUDY DESIGN As part of a wider prospect i ve blinded study investigating diagnostic accuracy of clinical variables , a secondary analysis was carried out to seek evidence of variables potentially valuable as predictors of screening ZJ block outcomes . PATIENT SAMPLE Chronic low back pain patients received screening ZJ blocks ( n=151 ) with 120 patients included in the analysis after exclusions . OUTCOME MEASURES Pain intensity was measured using a 100-mm visual analog scale , and responses were categorized according to 75 % through 95 % or more pain reduction in 5 % increments . METHODS Patients completed pain drawings , question naires , and a clinical examination before screening lumbar ZJ blocks . History , demographic and clinical variables were evaluated in cross tabulation and regression analyses with diagnostic accuracy values calculated for variables and variable clusters in relation to different pain reduction st and ards . RESULTS At the 75 % pain reduction st and ard , 24.5 % responded to screening ZJ blocks and 10.8 % responded at the 95 % st and ard . The central ization phenomenon is not associated with pain reduction using any st and ard . No variables were useful predictors of post-ZJ block pain reduction of less than 90 % . Seven clinical findings were associated with 95 % pain reduction after blocks . Five useful clinical prediction rules ( CPRs ) were found for ruling out a 95 % pain reduction ( 100 % sensitivity ) , and one CPR had a likelihood ratio of 9.7 , producing a fivefold improvement in posttest probability . CONCLUSIONS A negative extension rotation test , the central ization phenomenon , and four CPRs effectively rule out pain ablation after screening ZJ block . One CPR generates a fivefold improvement in posttest probability of a negative or positive response to ZJ block",
"Although radial tear of the annulus fibrosus can be detected on T2-weighted and Gd-DTPA-enhanced magnetic resonance ( MR ) images , the association between the annular tear on MR images and the symptomatic discs is unclear . The purpose of this study was to investigate the relationship between T2-weighted , gadolinium-DTPA-enhanced MR images and pain response through discography in patients with chronic low back pain . A total of 56 lumbar discs from 23 patients with chronic low back pain ( 13 to 47 years old ) underwent MR imaging ( T2-weighted , gadolinium-DTPA-enhanced MR images ) followed by provocative discography . The sensitivity , specificity , positive predictive value , and negative predictive value of T2-weighted and gadolinium-DTPA-enhanced MR images in detecting the symptomatic discs were calculated . The sensitivity , specificity , positive predictive value , and negative predictive value of T2-weighted images in detecting the symptomatic disc were 94 % , 71 % , 59 % , and 97 % , respectively . The sensitivity , specificity , positive predictive value , and negative predictive value of gadolinium-DTPA-enhanced images were 71 % , 75 % , 56 % , and 86 % , respectively . The high sensitivity and the high negative predictive value of T2-weighted MR imaging in detecting the symptomatic disc indicated that MR imaging can be a useful screening tool in avoiding unnecessary discography in patients with chronic low back pain",
"Previous research indicates that physical examination can not diagnose sacroiliac joint ( SIJ ) pathology . Earlier studies have not reported sensitivities and specificities of composites of provocation tests known to have acceptable inter-examiner reliability . This study examined the diagnostic power of pain provocation SIJ tests singly and in various combinations , in relation to an accepted criterion st and ard . In a blinded criterion-related validity design , 48 patients were examined by physiotherapists using pain provocation SIJ tests and received an injection of local anaesthetic into the SIJ . The tests were evaluated singly and in various combinations ( composites ) for diagnostic power . All patients with a positive response to diagnostic injection reported pain with at least one SIJ test . Sensitivity and specificity for three or more of six positive SIJ tests were 94 % and 78 % , respectively . Receiver operator characteristic curves and areas under the curve were constructed for various composites . The greatest area under the curve for any two of the best four tests was 0.842 . In conclusion , composites of provocation SIJ tests are of value in clinical diagnosis of symptomatic SIJ . Three or more out of six tests or any two of four selected tests have the best predictive power in relation to results of intra-articular anaesthetic block injections . When all six provocation tests do not provoke familiar pain , the SIJ can be ruled out as a source of current LBP",
"OBJECTIVE To compare the diagnostic accuracy of a multitest regimen of 5 sacroiliac joint ( SIJ ) pain provocation tests with fluoroscopically controlled double SIJ blocks using a short- and long-acting local anesthetic in order to reduce the exposure of patients to unnecessary invasive SIJ procedures . DESIGN Prospect i ve , observational study . SETTING Hospital setting . PARTICIPANTS Sixty patients with chronic low back pain . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Visual analog scale score and receiver operating characteristic ( ROC ) curve . RESULTS Twenty-seven patients responded positively to the blocks , of whom 23 were found positive after the multitest regimen and 4 were negative . For the nonresponders ( n=33 ) , these figures were 7 positive and 26 negative . The calculated sensitivity and specificity were .85 ( 95 % confidence interval [ CI ] , .72-.99 ) and .79 ( 95 % CI , .65-.93 ) , respectively . Positive and negative predictive values were .77 ( 95 % CI , .62-.92 ) and .87 ( 95 % CI , .74-.99 ) , respectively . The positive likelihood ratio was 4.02 ( 95 % CI , 2.04 - 7.89 ) ; the negative likelihood ratio was .19 ( 95 % CI , .07-.47 ) . The area under the ROC curve was .799 . CONCLUSIONS The test regimen with 3 or more positive tests is indicative of SIJ pain . It can be used in early clinical decision making to reduce the number of unnecessary minimally invasive diagnostic SIJ procedures",
"BACKGROUND CONTEXT Lumbar discography has been widely used for evaluating discogenic low back pain ( LBP ) . Comparison of pain responses from suspected symptomatic discs with pain responses from asymptomatic negative discs is routine . However , the ability of discography to distinguish asymptomatic morphologically abnormal discs from those that are symptomatic has been understudied . In addition , the discographic characteristics of negative discs in patients with chronic discogenic LBP have not been reported . Criteria for negative morphologically abnormal discs may be valuable for excluding discs from further treatment and examination . PURPOSE To determine if discography can distinguish asymptomatic discs among morphologically abnormal discs in patients with suspected chronic discogenic LBP and establish the st and ard characteristics of negative discs . STUDY DESIGN / SETTING Prospect i ve , experimental with control group . PATIENT SAMPLE Fifty-five discs from a control group of 16 healthy volunteers without current back pain ( 11 men , 5 women , 32 - 61 years of age , mean age : 47 years ) and 282 discs from a patient group of 90 LBP patients ( 59 men , 31 women , 20 - 70 years of age , mean age : 44.7 years ) were recruited . METHODS Discography was performed using a pressure-controlled manometric technique with an injection rate of 0.05 mL/s and a 3.5 mL restricted total volume . Concordance was rated as none/unfamiliar , or familiar . Pain was rated via a 0 - 10 numerical rating scale ( NRS ) . The pressure and volume at which pain was evoked and NRS pain responses at 15 , 30 , and 50 psi were recorded . Annular disruption grade was rated during the procedure by computed tomography discography and fluoroscopic imaging . Negative discogram required no pain described by the participant as \" familiar , \" with no pain responses > or=6/10 NRS at pressures Grade 3 annular tear . All discs in the asymptomatic control group satisfied negative response criteria . Among 282 patient group discs , 199 ( 70.6 % ) exhibited Grade 3 annular tear . Of 199 discs with Grade 3 annular tears , 104 ( 52.3 % ) satisfied negative response criteria and were categorized as the Neg-D group . The other 95 discs were categorized as a Pos-D group . Patients showed significantly lower pain tolerance relative to control subjects ( p pain scores were 0.47 NRS at 15 psi and 1.58 NRS at 50 psi . Mean Neg-D group pain scores were 0.11 NRS at 15 psi and 1.1 NRS at 50 psi . Discographic findings for the Pos-D group were significantly different from those of the control and Neg-D groups ( p Pain tolerance was significantly lower in patients relative to asymptomatic subjects . Negative patient discs and asymptomatic subject discs showed similar characteristics . Pressure-controlled manometric discography using strict criteria may distinguish asymptomatic discs among morphologically abnormal discs with Grade 3 annular tears in patients with suspected chronic discogenic LBP",
"Study Design . Prospect i ve r and omized study to compare the efficacy of facet joint injection with lidocaine and facet joint injection with saline in two groups of patients with low back pain , with and without clinical criteria that were determined in a previous study to implicate the facet joint as the primary source of the pain . Objectives . To assess the efficacy of single facet joint anesthesia versus placebo ( saline injections ) and to determine clinical criteria that are predictive of significant relief of LBP after injection . Summary of Background Data . There is no syndrome that discriminates between lower back pain caused by facet joint and that caused by other structures . Single or double facet joint anesthesia , and single photon emission computed tomography are expensive and time‐consuming procedures for selecting patients in controlled clinical trials with large population s. Methods . Results of a previous study showed that seven clinical characteristics were more frequent in patients who responded to facet joint anesthesia than in those who did not . In the current study , a group of 43 patients with lower back pain who met at least five criteria were compared with 37 patients who met fewer criteria . Patients r and omly received injection of either lidocaine or saline into the lower facet joints . The result was considered positive if more than 75 % pain relief was determined by visual analog scale . The patient , the radiologist , and the investigator were blinded . An analysis of variance was used to seek an interaction between clinical group effect and injection effect , and logistic regression analysis to select the best set of variables that would be predictive of minimum pain relief of 75 % after the injection . Results . There was a significant interaction between clinical group and injection effect ( P= 0.003 ) . In patients with back pain , lidocaine provided greater lower‐back pain relief than saline ( P = 0.01 ) . Lidocaine also‐provided greater pain relief in the back pain group than in the the nonpain group ( P = 0.02 ) . The presence of five among seven variables ( age greater than 65 years and pain that was not exacerbated by coughing , not worsened by hyperextension , not worsened by forward flexion , not worsened when rising from flexion , not worsened by extension‐rotation , and well‐relieved by recumbency ) , always including the last item , distinquished 92 % of patients responding to lidocaine injection and 80 % of those not responding in the lidocaine group . Conclusions . A set of five clinical characteristics can be used in r and omized studies to select lower back pain that will be well relieved by facet joint anesthesia . These characteristics should not , however , be considered as definite diagnostic criteria of lower back pain originating from facet joints",
"Study Design This study is a prospect i ve cross-sectional analytic study . Objectives The authors determined the prevalence and clinical features of patients with pain stemming from the lumbar zygapophysial joints . Summary of Background Data Previous studies have demonstrated a wide range of prevalence for zygapophysial joint pain and conflicting results with regard to clinical signs . Methods One hundred and seventy-six consecutive patients with chronic low back pain were investigated with a series of screening zygapophysial joint blocks using lignocaine and confirmatory blocks using bupivacaine . Results Forty-seven percent of patients had a definite or greater response to the screening injection at one or more levels but only 15 % had a 50 % or greater response to a confirmatory block . Response to zygapophysial joint injection was not associated with any single clinical feature or set of clinical features . Conclusions The zygapophysial joint is an important source of pain but the existence of a “ facet syndrome ” must be question ed",
"Abstract Disagreement still exists in the literature as to the significance of the high-intensity zone ( HIZ ) demonstrated on magnetic resonance imaging ( MRI ) as a potential pain ¶indicator in patients with low back pain . A prospect i ve blind study was therefore conducted to evaluate the lumbar disc high-intensity zone with the pain provocation response of lumbar discography . Consecutive patients with low back pain unresponsive to conservative treatment and being considered for spinal fusion were subjected to MRI followed by lumbar discography as a pre-operative assessment . The discographer was blinded to the results of the MRI scans . We used the chi-squared test to analyse our results . Ninety-two HIZs were identified in 73 patients , mainly occurring at L4/5 ( 48 % ) and L5/S1 ( 35 % ) . Significant correlation was found between abnormal disc morphology and the HIZ ( P similar pain reproduction ( P sensitivity , specificity and positive predictive value for pain reproduction were high , at 81 % , 79 % and 87 % respectively . The nature of the HIZ remains unknown , but it may represent an area of secondary inflammation as a result of an annular tear . We conclude from our study that the lumbar disc HIZ observed on MRI in patients with low back pain is likely to represent painful internal disc disruption",
"PURPOSE To investigate the predictive value of magnetic resonance ( MR ) imaging of abnormalities of the lumbar intervertebral disks , particularly with adjacent endplate changes , to predict symptomatic disk derangement , with discography as the st and ard . MATERIAL S AND METHODS Fifty patients aged 28 - 50 years with chronic low back pain and without radicular leg pain underwent prospect i ve clinical examination and sagittal T1- and T2-weighted and transverse T2-weighted MR imaging . Subsequently , patients underwent lumbar discography with a pain provocation test ( 116 disks ) . MR images were evaluated for disk degeneration , a high-signal-intensity zone , and endplate abnormalities . Results of pain provocation at discography were rated independently of the image findings as concordant or as nonconcordant or painless . Sensitivity , specificity , positive predictive value ( PPV ) , and negative predictive value ( NPV ) were calculated to assess the clinical relevance of MR abnormalities . RESULTS Normal disks on MR images were generally not painful at provocative discography ( NPV , 98 % ) . Disk degeneration ( sensitivity , 98 % ; specificity , 59 % ; PPV , 63 % ) and a high-signal-intensity zone ( sensitivity , 27 % ; specificity , 85 % ; PPV , 56 % ) were not helpful in the identification of symptomatic disk derangement . When only moderate and severe type I and type II endplate abnormalities were considered abnormal , all injected disks caused concordant pain with provocation ( sensitivity , 38 % ; specificity , 100 % ; PPV , 100 % ) . CONCLUSION Moderate and severe endplate abnormalities appear be useful in the prediction of painful disk derangement in patients with symptomatic low back pain",
"Study Design . This is a prospect i ve study of the validity of a positive test result in provocative lumbar discography for the diagnosis of “ discogenic pain . ” Objective . To investigate the hypothesis that provocative discography by strict criteria accurately identifies a low back pain illness due to a primary disc lesion . Summary and Background Data . According to the Sackett and Haynes criteria for establishing diagnostic test validity , no test without a gold st and ard external st and ard can be meaningfully applied . Provocative discography as a test for determining “ discogenic pain ” has , to date , not been compared against a gold st and ard . Absent a gold st and ard reference , there can be no validity assessment or systematic improvement of test accuracy . This is the first study to apply an external gold st and ard evaluation of the diagnostic validity of discography in any manner . Methods . Over a 5-year period using a strict enrollment protocol , 32 patients with low back pain and a positive single-level low-pressure provocative discogram , underwent spinal fusion . Subjects with known patient selection comorbidities were excluded . Generic surgical limitations /morbidity were controlled by comparison to the clinical outcomes of a strictly-matched cohort of 34 patients having a well-accepted single-level lumbar pathology ( unstable spondylolisthesis ) . Treatment success was compared between groups . Results . In the control-spondylolisthesis group , 23 of 32 patients ( 72 % ) met the highly effective success criteria compared with 8 of 30 in the presumed discogenic pain cohort ( 27 % ) . The proportion of patients who met the “ minimal acceptable outcome ” was 29 of 32 ( 91 % ) in the spondylolisthesis group and 13 of 30 ( 43 % ) in the presumed discogenic pain group . Adjusting for surgical morbidity and dropout failure , by either criteria of success , the best-case positive predictive value of discography was calculated to be 50 % to 60 % . Conclusions . Positive discography was not highly predictive in identifying bona fide isolated intradiscal lesions primarily causing chronic serious LBP illness in this first study comparing discography results to a gold st and ard",
"Study Design . A prospect i ve , consecutive , cohort study of patients with acute low back pain classified into subgroups based on examination data and treated with a specific treatment approach . Objective . To calculate the interrater reliability of a classification system , and to compare initial patient characteristics and outcomes of physical therapy treatment when a classification approach is used . Summary of Background Data . Classification of patients with low back pain into homogeneous subgroups has been identified as a research priority . Identifying relevant subgroups of patients could improve clinical outcomes and research efficiency . Methods . Consecutive patients referred to physical therapy for treatment of acute low back pain were evaluated and classified into one of four subgroups ( immobilization , mobilization , specific exercise , or traction ) before treatment . Physical therapy treatment was based on the patient ’s classification . The classifications were compared for initial patient characteristics , frequency and duration of physical therapy , and improvement in Oswestry scores . Results . In this study , 120 patients were evaluated and classified . Analysis of interrater reliability showed a kappa value of 0.56 . Differences were found among the classifications for age , initial Oswestry score , history of low back pain , symptom distribution , and average change in Oswestry score with treatment . Conclusions . Reaching a consensus regarding relevant patient subgroups requires data on the reliability and validity of existing classification systems . Further work is required to vali date improvement in treatment outcomes using a classification approach",
"OBJECTIVE The purpose of this study was to determine if vibration pain provocation could be combined with magnetic resonance imaging ( MRI ) to increase its specificity in identifying symptomatic disc disruption identified by discography . DESIGN Prospect i ve single-blind study . SETTING Data were collected at a spine specialty clinic and at a diagnostic imaging center . PATIENTS A total of 206 discs in 78 patients ( 41 males , 37 females ; average age , 39.7 years ; range , 18 - 73 years ) were evaluated by MRI , spinous process vibration , and discography . INTERVENTIONS A h and -held prototype vibrator was applied to the spinous process of each intervertebral disc level to be evaluated . The type of pain provoked with vibration as well as with discography was recorded as painless , dissimilar to clinical pain , or similar/exact reproduction of clinical pain . The discograms and MRI scans were scored on a 0 - 4 scale . A system was defined for combining the vibration results with MRI . OUTCOME MEASURES The results of the vibration and MRI were compared with the results of computed tomography/discography to determine how well the results of the evaluations agreed . RESULTS Vibration pain provocation agreed with discographic pain provocation in 70.9 % of the discs . The specificity of MRI compared with discographic findings was only 55.7 % . However , this figure improved significantly to 81.3 % when relying on the vibration pain provocation in discs with mild or moderate disruption . The sensitivity of the combined evaluation was 85.9 % and the accuracy 83.0 % . CONCLUSIONS A small h and -held vibrator could produce pain provocation results similar to those obtained by discography . Results of this noninvasive pain provocation method can improve the specificity and accuracy of MRI in identifying symptomatic disc lesions",
"Study Design A prospect i ve analysis of the clinical outcome of a consecutive series of patients treated with posterior lumbar arthrodesis . Preoperative data were collected retrospectively by chart review . Objectives To measure by independent review the clinical outcome of posterolateral intertransverse fusion as a treatment for discogenic low back pain in a highly selected group of patients . Summary of Background Data Although numerous studies have reported on the surgical management of degenerative disc disease , they have been difficult to interpret because they lack patient‐oriented outcome assessment and objective pain measurement criteria , independent review , and include patients with diagnoses other than degenerative disc disease . Methods Between 1991 and February 1993 all patients seen by a single surgeon , evaluated with magnetic resonance imaging and discography , and treated with posterolateral lumbar fusion were review ed by independent investigation . Outcome was assessed in the areas of radiographic fusion , pain , function , and patient satisfaction . Results Twenty‐three patients ( 12 women , 11 men ; 100 % follow‐up an average of 47 months after surgery [ range , 24–84 months ] ) met the inclusion criteria . Overall , 39 % had a good or excellent result , 13 % fair , and 48 % poor . Nine of 10 patients receiving worker 's compensation had a poor result ; four of five patients with radiographic pseudarthrosis had a poor result . Statistically significant improvement in the visual analogue scale was noted in the good and excellent group ( P = 0.0001 ) and the fair group ( P = 0.002 ) with no change in the poor group . Patients out of work more than 3 months before surgery tended to have poor results . Overall , 56 % of patients were extremely satisfied with the result of their surgery . Conclusion Posterolateral intertransverse fusion can be used to successfully manage chronic discogenic back pain . However , patient selection remains a challenge , and successful outcome appears to be limited in the subset of patients receiving worker 's compensation and those chronically disabled . Prospect i ve and r and omized study with objective pain criteria , independent review , and patient‐oriented outcome is recommended",
"This prospect i ve study was design ed to determine the prevalence of lumbar facet joint pain in a consecutive series of patients with chronic low back pain treated at an interventional , multidisciplinary private pain management practice utilizing double diagnostic blocks , to determine the prevalence of false positive rate of uncontrolled facet joint blocks , and to determine the relationship of clinical features of responders and non-responders to double diagnostic blocks . One hundred and twenty patients with low back pain with or without lower extremity pain were selected . The procedure consisted of diagnostic blocks using lidocaine and bupivacaine on separate occasions , usually two weeks apart . Each facet joint nerve was infiltrated with either 0.4 to 0.6 ml of 1 % lidocaine ( Xylocaine(R ) ) or 1 % lidocaine ( Xylocaine(R ) ) and 0.25 % bupivacaine ( Marcaine(R ) ) . A definite response was defined as substantial with at least 75 % relief of pain in the symptomatic area following local anesthetic block . Confirmatory blocks using bupivacaine 0.25 % were performed at the same levels as the first injection if definite relief was obtained . The response to bupivacaine blocks which lasted longer than the lidocaine blocks was accepted as a positive response . All blocks were performed under fluoroscopic guidance . Eighty-one patients ( 67.5 % ) reported a definite response to lidocaine blocks . Confirmatory blocks with bupivacaine were performed in all 81 patients with 54 patients , i.e. 45 % of total sample or 66.6 % of lidocaine positive group reporting definite response with a false positive rate of 41 % . Prevalence and relationship of pain referral pattern in patients with and without facet joint pain confirmed by double blocks showed no significant correlation . We found no relationship between the history , physical findings , age , gender , trauma , duration of pain , and diagnostic blocks . However , history of previous surgery showed a negative correlation as only 29 % of the patients after previous surgery were positive in contrast to 51 % of the nonsurgical population . The results of this study echo previous concerns of reliability of uncontrolled single blocks , history , and clinical features . This study demonstrated that the facet joint is a source of pain in 45 % of the patients suffering with chronic low back pain in an interventional pain management setting in a private practice",
"BACKGROUND CONTEXT Whether discographic injections would be positive in subjects with benign persistent \" backache \" who are not seeking treatment is unknown . This information is important , because benign backache undoubtedly co-exists in patients with chronic low back pain ( CLBP ) illness that is not discogenicin origin . If these subjects had a high rate of positive discography , the high background incidence of common backache would allow many positive tests in patients in whom discogenic processes were unrelated to their severe CLBP illness . Conversely , if subjects with benign low back pain rarely if ever had significant concordant pain reproduction on disc injections , the basic tenet of discographic diagnosis would be strengthened . PURPOSE To compare , using a strict experimental design , the relative pain and concordancy response to provocative discography in subjects with clinical ly insignificant \" backache \" and clinical subjects with CLBP illness considering surgical treatment . STUDY DESIGN Comparison of experimental disc injections in subjects with persistent mild backache and those with chronic low back pain ( CLBP ) illness . PATIENT SAMPLE Twenty-five subjects with mild persistent low back pain ( LBP ) were recruited for an experimental discography study . Subjects were recruited from a clinical study of patients having had cervical spine surgery . Inclusion criteria required that subjects not be receiving or seeking medical treatment for LBP , be taking no medications for backache , have no activity restrictions because of LBP , and have normal psychometric scores . To more closely approximate the pain behavior in CLBP illness , 50 % ( 12 ) of the \" backache \" group were recruited with a chronic painful condition ( neck/shoulder ) unrelated to the low back . CLBP subjects , patients coming to discography for consideration of surgical treatment , were used as control subjects . OUTCOME MEASURES Results of discography were determined using the criteria of Walsh et al. : pain response of 3 or greater , two or more pain behaviors , a negative \" control \" discographic injection , and a similar or exact concordancy rating . METHODS Discography was performed on experimental subjects and control patients . Experienced raters , who were blinded to control versus experimental status of the subjects , scored the magnetic resonance image , discogram , psychometric tests and discography videotapes of the subjects ' pain behavior . RESULTS Thirteen of 25 volunteer subjects had pain rated as \" bad \" or worse with disc injection . There were 12 painful and fully concordant disc injections in 9 of these 25 \" backache \" subjects ( 36 % ) . These injections met all the Walsh et al. criteria for a positive diagnosis of discogenic pain . All positive discs had annular disruption to or through the outer annulus . Of the 9 subjects with positive discograms , 3 had no chronic pain states and 6 did . All subjects with positive injections had negative control discs . In comparison , in 52 subjects with CLBP illness 38 ( 73 % ) had at least one positive disc injection . CONCLUSIONS In a group of volunteer subjects with persistent \" backache , \" 36 % were found to have significant pain on disc injection , which is reported to be concordant with their usual pain . The presence of positive concordant pain responses and negative control discs in 33 % of subjects without CLBP illness seriously challenges the specificity of provocative discography in identifying a clinical ly relevant spinal pathology",
"Study Design A prospect i ve study was done to assess the diagnostic value of radionuclide imaging ( bone scan ) in the evaluation of sacroiliac joint syndrome . Objectives To determine the sensitivity and specificity of radionuclide imaging in establishing a diagnosis of sacroiliac joint syndrome in patients with low back pain . Summary of Background Data There is no pathognomonic symptom or sign to establish the diagnosis of sacroiliac joint syndrome . It has been accepted that confirmation of sacroiliac joint syndrome requires relief of pain , a positive response to a sacroiliac joint block . Bone scanning has been proposed as a useful imaging technique to evaluate for sacroiliac joint syndrome . The authors explored the use of nuclear imaging as a cost‐effective and noninvasive technique in the diagnostic algorithm of sacroiliac joint syndrome . Methods Patients presenting to the author 's Spine Center with complaints of low back pain including the region of the sacral sulcus were screened for inclusion into this study . Positive response to three provocative sacroiliac joint maneuvers was requisite , two of which had to be Patrick 's test and pain with palpation over the sacral sulcus . Patients who met these criteria were entered into a physical therapy program comprised of lumbar spine stabilization techniques and excluded any interventions considered specific for sacroiliac joint syndrome . Those whose symptoms failed to improve with this program underwent bone scan and fluoroscopically guided sacroiliac joint block . Response to sacroiliac joint block was assessed with pre‐ and post‐block visual analog scale scores completed by the patient . A reduction of the VAS rating by at least 80 % was considered a positive response to sacroiliac joint block . Results Fifty consecutive patients met the author 's criteria and underwent bone scan and sacroiliac joint block . Thirty‐one patients who had positive responses to sacroiliac joint block comprised the positive sacroiliac joint block group . Nineteen patients had less than 80 % pain reduction with sacroiliac joint block and were labeled the negative sacroiliac joint block group . Four patients had positive bone scans , all of whom were in the positive sacroiliac joint group . Conclusions The results demonstrated very low sensitivity and high specificity of nuclear imaging in the evaluation of sacroiliac joint syndrome . The authors do not recommend bone scan in the diagnostic algorithm for sacroiliac joint syndrome",
"Study Design . The presence or absence of rapidly central izing , peripheralizing , or abolishing low back and radiating pain , as identified during a McKenzie mechanical lumbar assessment of patients with chronic lumbar pain , was compared prospect ively with discographic pain provocation and anular competency . Objectives . To evaluate any relation between the responses of central ization and peripheralization with discographic findings . Summary of Background Data . Central ization of referred pain has been reported as a very common occurrence during McKenzie assessment and treatment . Patients whose pain central izes have been shown to achieve superior treatment outcomes . A dynamic internal disc model has been hypothesized as an underlying mechanism for central ization that has not been studied previously . Methods . Patients with chronically disabling low back pain who were referred for discography underwent preliminary blinded McKenzie clinical assessment and were categorized into three groups by their pain response . Patterns , or lack thereof , of pain response were then compared with blinded discographic pain provocation and anular findings . Results . During the McKenzie assessment , the referred pain of 50 % central ized with 74 % having positive discograms , of which 91 % had an intact anulus . The pain of 25 % peripheralized only ( would not central ize ) ; 69 % of these had positive discograms , but only 54 % had an intact anulus . The distal pain of 25 % did not respond at all , and only 12.5 % of these had positive discograms . Conclusion . The McKenzie assessment process reliably differentiated discogenic from nondiscogenic pain ( P < 0.001 ) as well as competent from an incompetent anulus ( P < 0.042 ) in symptomatic discs and was superior to magnetic resonance imaging in distinguishing painful from nonpainful discs",
"Study Design . One hundred and three lumbar intervertebral discs ( L3/4-L5/S1 ) of 36 patients with low back pain were examined with computed tomography ( CT ) diskography and magnetic resonance imaging ( MRI ) . Objectives . To determine whether lumbar endplate degeneration correlates with the degree of disc degeneration or disc rupture and to determine if there is an association between pain provocation during diskography and lumbar endplate degeneration . Summary of Background Data . There have been numerous attempts to explain the pathogenesis of pain provocation during diskography , but the possibility of endplate degeneration as a source of pain has not been widely assessed . Methods . One hundred and three lumbar intervertebral discs ( 36 L3/4 , 36 L4/5 , and 31 L5/S1 intervertebral discs ) of 36 patients were examined . On the basis of MRI , the intervertebral discs were divided into four categories based on the degree of endplate degeneration . Based on pain provocation on diskography , the intervertebral discs were divided into three categories : no pain , indifferent/untypical pain , and familiar/typical pain . Based on disc degeneration and disc rupture , the intervertebral discs were divided into four categories in accordance with the Dallas Discogram Description : Grade s 0–3 of both degeneration and rupture . Results . There was a positive correlation between endplate degeneration and disc degeneration and a positive correlation between disc rupture and pain provocation , but there was no association between endplate degeneration and disc rupture and no correlation between endplate degeneration and pain provocation on diskography . Conclusions . This study showed a stronger association between endplate degeneration and disc degeneration than between endplate degeneration and disc rupture . The results indicate that the contrast injection during diskography reflects mainly pain of discogenic origin , whereas the possible pain associated with endplate damage can not be depicted by CT diskography",
"BACKGROUND CONTEXT Research has demonstrated some progress in using a clinical examination to predict discogenic or sacroiliac ( SI ) joint sources of pain . No clear predictors of symptomatic lumbar zygapophysial joints have yet been demonstrated . PURPOSE To identify significant components of a clinical examination that are associated with symptomatic lumbar discs , zygapophysial joints and SI joints . STUDY DESIGN A prospect i ve , criterion-related concurrent validity study performed at a private radiology practice specializing in spinal diagnostics . PATIENT SAMPLE The sample consisted of 81 patients with chronic lumbopelvic pain referred for diagnostic injections . OUTCOME MEASURES Contingency tables were constructed for nine features of the clinical evaluation compared with the results of diagnostic injections . Statistical analysis included chi-squared test for independence , phi and odds ratios with confidence intervals . METHOD Patients received blinded clinical examinations by physical therapists , and diagnostic injections were used as the criterion st and ard . RESULTS Significant relationships were found between discogenic pain and central ization of pain during repeated movement testing , and pain when rising from sitting . Lumbar zygapophysial joint pain was associated with absence of pain when rising from sitting . Sacroiliac joint pain was related to three or more positive pain provocation tests , pain when rising from sitting , unilateral pain and absence of lumbar pain . CONCLUSIONS Significant correlations exist between clinical examination findings and symptomatic lumbar discs , zygapophysial and SI joints . The strongest relationships were seen between SI joint pain and three or more positive pain provocation tests , central ization of pain for symptomatic discs and absence of pain when rising from sitting for symptomatic lumbar zygapophysial joints",
"BACKGROUND CONTEXT The \" central ization phenomenon \" ( CP ) is the progressive retreat of referred pain towards the spinal midline in response to repeated movement testing ( a McKenzie evaluation ) . A previous study suggested that it may have utility in the clinical diagnosis of discogenic pain and may assist patient selection for discography and specific treatments for disc pain . PURPOSE Estimation of the diagnostic predictive power of central ization and the influence of disability and patient distress on diagnostic performance , using provocation discography as a criterion st and ard for diagnosis , in chronic low back pain patients . STUDY DESIGN / SETTING This study was a prospect i ve , blinded , concurrent , reference st and ard-related validity design carried out in a private radiology clinic specializing in diagnosis of chronic spinal pain . PATIENT SAMPLE Consecutive patients with persistent low back pain were referred to the study clinic by orthopedists and other medical specialists for interventional radiological diagnostic procedures . Patients were typically disabled and displayed high levels of psychosocial distress . The sample included patients with previous lumbar surgery , and most had unsuccessful conservative therapies previously . OUTCOME MEASURES DIAGNOSIS results of provocation discography . INDEX TEST The CP . Psychometric evaluation : Rol and -Morris , Zung , Modified Somatic Perception question naires , Distress Risk Assessment Method , and 100-mm visual analog scales for pain intensity . METHODS Patients received a single physical therapy examination , followed by lumbar provocation discography . Sensitivity , specificity , and likelihood ratios of the CP were estimated in the group as a whole and in subgroups defined by psychometric measures . RESULTS A total of 107 patients received the clinical examination and discography at two or more levels and post-discography computed tomography . Thirty-eight could not tolerate a full physical examination and were excluded from the main analysis . Disability and pain intensity ratings were high , and distress was common . Sensitivity , specificity , and positive likelihood ratios for central ization observed during repeated movement testing for pain distribution and intensity changes were 40 % , 94 % , and 6.9 respectively . In the presence of severe disability , sensitivity , specificity , and positive likelihood ratios were 46 % , 80 % , 3.2 and for distress , 45 % , 89 % , 4.1 . In the subgroups with moderate , minimal , or no disability , sensitivity and specificity were 37 % , 100 % and for no or minimal distress 35 % , 100 % . CONCLUSIONS Central ization is highly specific to positive discography but specificity is reduced in the presence of severe disability or psychosocial distress"
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BACKGROUND Consumption of nuts has been associated with a decreased risk of cardiovascular disease events and death . Walnuts in particular have a unique profile : they are rich in polyunsaturated fatty acids , which may improve blood lipids and other cardiovascular disease risk factors . OBJECTIVES We aim ed to conduct a literature review and a meta- analysis to combine the results from several trials and to estimate the effect of walnuts on blood lipids . DESIGN Literature data bases were search ed for published trials that compared a specifically walnut-enhanced diet with a control diet . We conducted a r and om-effects meta- analysis of weighted mean differences ( WMDs ) of lipid outcomes . RESULTS Thirteen studies representing 365 participants were included in the analysis . Diets lasted 4 - 24 wk with walnuts providing 10 - 24 % of total calories . When compared with control diets , diets supplemented with walnuts result ed in a significantly greater decrease in total cholesterol and in LDL-cholesterol concentrations ( total cholesterol : WMD = -10.3 mg/dL , P HDL cholesterol and triglycerides were not significantly affected by walnut diets more than with control diets ( HDL cholesterol : WMD = -0.2 , P = 0.8 ; triglycerides : WMD = -3.9 , P = 0.3 ) . Other results reported in the trials indicated that walnuts provided significant benefits for certain antioxidant capacity and inflammatory markers and had no adverse effects on body weight [ body mass index ( kg/m(2 ) ) : WMD = -0.4 , P = 0.5 ; weight ( kg ) : WMD = -0.05 , P = 0.97 ] . CONCLUSIONS Overall , high-walnut-enriched diets significantly decreased total and LDL cholesterol for the duration of the short-term trials . Larger and longer-term trials are needed to address the effects of walnut consumption on cardiovascular risk and body weight
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"BACKGROUND Atherosclerosis is a chronic inflammatory disease . We previously reported that a diet high in alpha-linolenic acid ( ALA ) reduces lipid and inflammatory cardiovascular disease risk factors in hypercholesterolemic subjects . OBJECTIVE The objective was to evaluate the effects of a diet high in ALA on serum proinflammatory cytokine concentrations and cytokine production by cultured peripheral blood mononuclear cells ( P BMC s ) from subjects fed the experimental diets . DESIGN A r and omized , controlled , 3-diet , 3-period crossover study design was used . Hypercholesterolemic subjects ( n = 23 ) were assigned to 3 experimental diets : a diet high in ALA ( ALA diet ; 6.5 % of energy ) , a diet high in linoleic acid ( LA diet ; 12.6 % of energy ) , and an average American diet ( AAD ) for 6 wk . Serum interleukin (IL)-6 , IL-1beta , and tumor necrosis factor-alpha ( TNF-alpha ) concentrations and the production of IL-6 , IL-1beta , and TNF-alpha by P BMC s were measured . RESULTS IL-6 , IL-1beta , and TNF-alpha production by P BMC s and serum TNF-alpha concentrations were lower ( P ALA diet than with the LA diet or AAD . P BMC production of TNF-alpha was inversely correlated with ALA ( r = -0.402 , P = 0.07 ) and with eicosapentaenoic acid ( r = -0.476 , P = 0.03 ) concentrations in P BMC lipids with the ALA diet . Changes in serum ALA were inversely correlated with changes in TNF-alpha produced by P BMC s ( r = -0.423 , P antiinflammatory effects by inhibiting IL-6 , IL-1beta , and TNF-alpha production in cultured P BMC s. Changes in P BMC ALA and eicosapentaenoic acid ( derived from dietary ALA ) are associated with beneficial changes in TNF-alpha release . Thus , the cardioprotective effects of ALA are mediated in part by a reduction in the production of inflammatory cytokines",
"Epidemiologic studies and clinical trials have demonstrated that the unique fatty acid profile of nuts beneficially affects serum lipids/lipoproteins , reducing cardiovascular disease ( CVD ) risk . Nuts are low in SFA and high in PUFA and monounsaturated fatty acids ( MUFA ) . Macadamia nuts are a rich source of MUFA . A r and omized , crossover , controlled feeding study ( 5-wk diet periods ) compared a Macadamia nut-rich diet [ 42.5 g ( 1.5 ounces)/8.79 MJ ( 2100 kcal ) ] [ MAC ; 33 % total fat ( 7 % SFA , 18 % MUFA , 5 % PUFA ) ] vs. an average American diet [ AAD ; 33 % total fat ( 13 % SFA , 11 % MUFA , 5 % PUFA ) ] on the lipid/lipoprotein profile of mildly hypercholesterolemic ( n = 25 ; 15 female , 10 male ) subjects . Serum concentrations of total cholesterol ( TC ) and LDL cholesterol ( LDL-C ) following the MAC ( 4.94 + /- 0.17 mmol/L , 3.14 + /- 0.14 mmol/L ) were lower than the AAD ( 5.45 + /- 0.17 mmol/L , 3.44 + /- 0.14 mmol/L ; P serum non-HDL cholesterol ( HDL-C ) concentration and the ratios of TC : HDL-C and LDL-C : HDL-C were reduced following consumption of the MAC diet ( 3.83 + /- 0.17 , 4.60 + /- 0.24 , and 2.91 + /- 0.17 , respectively ) compared with the AAD ( 4.26 + /- 0.17 , 4.89 + /- 0.24 , and 3.09 + /- 0.18 , respectively ; P serum triglyceride concentration . Thus , macadamia nuts can be included in a heart-healthy dietary pattern that reduces lipid/lipoprotein CVD risk factors . Nuts as an isocaloric substitute for high SFA foods increase the proportion of unsaturated fatty acids and decrease SFA , thereby lowering CVD risk",
"Lifestyle modification is the cornerstone of population -based strategies for prevention of coronary heart disease and is the first line of therapy in patients with hypercholesterolemia . Diets low in saturated fatty acids and cholesterol have long been recommended to decrease low-density lipoprotein ( LDL ) cholesterol levels and reduce cardiovascular risk ( 1 ) . Ample evidence suggests that polyunsaturated fatty acids and monounsaturated fatty acids have a similar cholesterol-lowering effect when substituted for saturated fatty acids ( 2 - 4 ) . However , most studies of fatty acids and blood lipids have been done with fats and oils , rarely with whole fatty foods . Because people usually buy and consume whole food products , it is desirable to know the effects of specific foods on risk factors for coronary heart disease . Recent reports suggest that the regular consumption of nuts might reduce cardiovascular risk ( 5 ) . Walnuts are particularly rich in polyunsaturated fatty acids ( 6 ) , and epidemiologic evidence suggests that frequent walnut consumption protects against coronary heart disease ( 7 ) . In a controlled feeding trial by Sabat and colleagues ( 8) , a diet in which walnuts represented 55 % of the energy from fat reduced blood cholesterol levels in normal young men when compared with a st and ard low-fat diet . However , the results can not easily be extrapolated to the population at risk for coronary heart disease because women , older age groups , and hypercholesterolemic persons were not studied ( 8) . In addition , because meals were served at a metabolic kitchen , the study did not address the question of whether free-living persons would incorporate substantial quantities of walnuts into their diets . Because oxidized LDL plays a key role in atherogenesis ( 9 ) and oxidative damage involves peroxidation of polyunsaturated fatty acids in LDL lipids ( 10 ) , there is concern that walnut intake may promote LDL oxidation . Therefore , we design ed a dietary intervention study in free-living adult men and women with polygenic hypercholesterolemia to compare the effects of a walnut-rich diet with those of a cholesterol-lowering Mediterranean diet on serum lipid levels , lipoprotein levels , and LDL resistance to oxidation . Methods Patients Adult men and women with polygenic hypercholesterolemia attending the Lipid Clinic of the Hospital Clnic of Barcelona were eligible if they had serum LDL cholesterol concentrations greater than 3.36 mmol/L ( 130 mg/dL ) and triglyceride concentrations less than 2.82 mmol/L ( 250 mg/dL ) ; no evidence of alcohol , tobacco , or drug abuse ; absence of diabetes mellitus and liver , kidney , thyroid , or other endocrine diseases , as assessed by medical history , a complete physical examination , and laboratory tests ; no intake in the previous 8 weeks of medications known to affect lipid metabolism , including hypolipidemic agents and estrogen compounds in women ; infrequent consumption of nuts and no known history of allergy to them ; and no use of multivitamin or vitamin E supplements . Because the target population had common ( polygenic ) hypercholesterolemia , we excluded persons whose elevated blood cholesterol levels had a strong genetic basis ( such as heterozygous familial hypercholesterolemia or familial combined hyperlipidemia ) , as established by st and ard criteria . On admission to the Lipid Clinic , all patients were advised to follow a Mediterranean-type hypolipidemic diet ( 11 ) . For a crossover design , statistical power calculations indicated that to detect mean differences of 0.39 mmol/L ( 15 mg/dL ) , 34 patients would need to complete the two treatment periods ( statistic , 0.05 ; power>0.8 ) . From a computerized register of clinical records , 75 hypercholesterolemic patients ( 35 women and 40 men ) who initially met the eligibility criteria were selected for screening and were asked to participate in the study . They were offered free walnuts but no monetary compensation . Study Design A crossover design was used . Patients were r and omly assigned to the two diet sequences by using a computer-generated r and om-number table , with stratification by sex . Because patients followed each diet for 6 weeks and lipoprotein changes due to dietary intervention stabilize in less than 4 weeks ( 12 ) , we did not incorporate a washout period between diets . In their crossover feeding study with walnuts , Sabat and colleagues ( 8) did not observe a carryover effect . In the week before the trial began , patients received expert dietary counseling individually and in a group class . Twice during the pretrial week and on weeks 5 and 6 of each one of the two dietary periods , patients came to the clinic for a medical visit , an interview with the dietitian , anthropometric measurements , and blood extraction . The main outcomes of the study were changes in serum levels of total and LDL cholesterol from the control diet period to the walnut diet period . Secondary outcomes were changes in other lipid variables and oxidizability of LDL particles . The study protocol was approved by the institutional review board of the Hospital Clnic of Barcelona , and all patients gave informed consent . Diets The experimental diets were individually prescribed and were based on estimated energy requirements . Because participants ate on their own , detailed dietary information was provided to them and , if appropriate , to their partners . Diets were calculated in increments of 200 kcal to cover the range from 1600 to 2200 kcal . The control diet was Mediterranean and was composed of natural foodstuffs . Red meat and eggs were limited , vegetable products and fish were emphasized , olive oil was indicated for culinary use , and no nuts were allowed . The walnut diet was similar to the control diet , but walnuts partially replaced olive oil and other fatty foods . Prepackaged daily allowances of raw , shelled walnuts were provided daily in amounts varying from 41 g to 56 g ( the equivalent of 8 to 11 walnuts ) , according to the participants ' total energy intake . Walnuts were consumed as snacks or with meals in desserts or salads . In the walnut diet , walnuts contributed approximately 18 % of the total energy and 35 % of the total fat . To improve compliance , each family unit was given 1000-g packs of walnuts at the beginning of the walnut diet period . Adherence to the study diets was carefully monitored . Unannounced 24-hour diet recalls were performed weekly by telephone during the two dietary periods , for a total of 12 recalls per patient . This method allows reliable estimations of food intake ( 13 ) . The nutrient composition of the diets was calculated with Food Processor Plus software , version 5.0 ( ESHA Research , Salem , Oregon ) , which was adapted to nutrient data bases of specific Mediterranean foods when appropriate . We defined noncompliance as at least 20 % deviation from dietary instructions regarding walnut or nutrient intake . Compliance during the walnut diet was also assessed at each clinic visit by a count of the empty walnut packages . The fatty acid content of LDL lipids was analyzed as a biological measure of adherence to the prescribed diets . Laboratory Measurements Blood sample s were obtained after an overnight fast , and serum and EDTA plasma were collected and processed immediately . Serum lipid and apolipoprotein levels were determined as described elsewhere ( 11 ) . In brief , serum cholesterol and triglyceride levels were measured by using enzymatic reagents ( Trinder , Bayer Diagnostics , Tarrytown , New York ) adapted to a Cobas Mira automated analyzer ( Hoffmann-LaRoche , Basel , Switzerl and ) . High-density lipoprotein ( HDL ) cholesterol was quantified after precipitation with phosphotungstic acid and magnesium chloride . Levels of apolipoprotein A-I and apolipoprotein B were determined by an immunoturbidimetric method ( Unimate 3 , Roche Diagnostic Systems , Basel , Switzerl and ) . Measurements of the cholesterol content of very-low-density lipoprotein particles and LDL particles were based on preparative ultracentrifugation ( 11 ) . Lipoprotein(a ) levels were measured by using an immunoturbidimetric method ( Lipoprotein[a ] SPQ II Test Kit , DiaSorin , Stillwater , Minnesota ) . To obtain the LDL fraction for fatty acid and oxidizability studies , lipoproteins were fractionated by sequential centrifugation adjusting with NaBr to separate very-low-density lipoprotein particles ( d=1.006 g/mL ) and to obtain LDL particles ( d=1.063 g/mL ) , as described elsewhere ( 14 ) . Low-density lipoprotein fatty acids were measured by capillary gas chromatography in the cholesteryl ester , phospholipid , and triglyceride lipid fractions ( 14 ) . Low-density lipoprotein susceptibility to oxidation was determined by measuring the -tocopherol content of LDL particles and conjugated diene kinetics after incubation of 50 g of LDL protein with 5 mol of copper sulfate at 37 C ( 15 , 16 ) . Statistical Analysis The two measurements obtained at baseline and at the end of each dietary period were averaged . Means and SDs are presented for each measurement . With methods described by Fleiss ( 17 ) , two-tailed t-tests were used to compare changes in outcome variables in response to dietary treatment and diet period and carryover effects for the two-period crossover design . Differences between the walnut and control diets were also tested by analysis of covariance using general linear models ; baseline values or sex were used as covariates . Analyses were performed by using SAS software ( SAS , Inc. , Cary , North Carolina ) ( 18 ) . Role of the Funding Sources The California Walnut Commission provided funding and walnuts . Research grants were also obtained from national and local nonprofit agencies . The funding sources were not involved in the design of the study and had no role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . None of the authors has any financial interest in the nut food industry . Results Patient Characteristics Of the 75 eligible patients , 20 left the study before r and omization for",
"Background —Epidemiological studies suggest that nut intake decreases coronary artery disease ( CAD ) risk . Nuts have a cholesterol-lowering effect that partly explains this benefit . Endothelial dysfunction is associated with CAD and its risk factors and is reversed by antioxidants and marine n-3 fatty acids . Walnuts are a rich source of both antioxidants and & agr;-linolenic acid , a plant n-3 fatty acid . Methods and Results —To test the hypothesis that walnut intake will reverse endothelial dysfunction , we r and omized in a crossover design 21 hypercholesterolemic men and women to a cholesterol-lowering Mediterranean diet and a diet of similar energy and fat content in which walnuts replaced ≈32 % of the energy from monounsaturated fat . Participants followed each diet for 4 weeks . After each intervention , we obtained fasting blood and performed ultrasound measurements of brachial artery vasomotor function . Eighteen subjects completing the protocol had suitable ultrasound studies . Compared with the Mediterranean diet , the walnut diet improved endothelium-dependent vasodilation and reduced levels of vascular cell adhesion molecule-1 ( P both ) . Endothelium-independent vasodilation and levels of intercellular adhesion molecule-1 , C-reactive protein , homocysteine , and oxidation biomarkers were similar after each diet . The walnut diet significantly reduced total cholesterol ( −4.4±7.4 % ) and LDL cholesterol ( −6.4±10.0 % ) ( P 0.05 for both ) . Cholesterol reductions correlated with increases of both dietary & agr;-linolenic acid and LDL & ggr;-tocopherol content , and changes of endothelium-dependent vasodilation correlated with those of cholesterol-to-HDL ratios ( P improves endothelium-dependent vasodilation in hypercholesterolemic subjects . This finding might explain the cardioprotective effect of nut intake beyond cholesterol lowering",
"Background Tocopherols may protect against prostate cancer and cardiovascular disease ( CVD ) . Methods We assessed the effect of walnuts , which are rich in tocopherols , on markers of prostate and vascular health in men at risk for prostate cancer . We conducted an 8-week walnut supplement study to examine effects of walnuts on serum tocopherols and prostate specific antigen ( PSA ) . Subjects ( n = 21 ) consumed ( in r and om order ) their usual diet + /- a walnut supplement ( 75 g/d ) that was isocalorically incorporated in their habitual diets . Prior to the supplement study , 5 fasted subjects participated in an acute timecourse experiment and had blood taken at baseline and 1 , 2 , 4 , and 8 h after consuming walnuts ( 75 g ) . Results During the timecourse experiment , triglycerides peaked at 4 h , and gamma-tocopherol ( γ-T ) increased from 4 to 8 h. Triglyceride – normalized γ-T was two-fold higher ( P = 0.01 ) after 8 versus 4 h. In the supplement study , change from baseline was + 0.83 ± 0.52 μmol/L for γ-T , -2.65 ± 1.30 μmol/L for alpha-tocopherol ( α-T ) and -3.49 ± 1.99 for the tocopherol ratio ( α-T : γ-T ) . A linear mixed model showed that , although PSA did not change , the ratio of free PSA : total PSA increased and approached significance ( P = 0.07 ) . The α-T : γ-T ratio decreased significantly ( P = 0.01 ) , partly reflecting an increase in serum γ-T , which approached significance ( P = 0.08 ) . Conclusion The significant decrease in the α-T : γ-T ratio with an increase in serum γ-T and a trend towards an increase in the ratio of free PSA : total PSA following the 8-week supplement study suggest that walnuts may improve biomarkers of prostate and vascular status",
"OBJECTIVE Nuclear transcription factor kappaB ( NF-kappaB ) plays a key role in the inflammatory response and can be modulate by dietary fat . We have examined the effect of three diets , with different fat composition , on the activation of NF-kappaB on peripheral blood mononuclear cells ( P BMC s ) . METHODS Sixteen healthy men followed three 4-week diets , in a r and omised crossover design : a Western diet , rich in saturated fat ( SFA ) [ 22 % SFA , 12 % monounsaturated fat ( MUFA ) and 0 , 4 alpha-linolenic acid ] ; a Mediterranean diet [ alpha-linolenic acid ] , and a low fat diet enriched in alpha-linolenic acid [ NF-kappaB ( electrophoretic mobility shift assay ) in mononuclear cells and plasma concentrations ( ELISA ) of soluble vascular cellular adhesion molecule 1 ( VCAM-1 ) were examined after either diets . RESULTS Western diet increased 2.7-fold NF-kappaB compared with the Mediterranean diet ( p=0.038 ) and 1.79-fold with the alpha-linolenic acid diet ( p=0.07 ) . No differences were found between the last two . Furthermore , an increase on plasma VCAM-1 was observed with the Western diet ( p Mediterranean diet diminished NF-kappaB activation in mononuclear cells , compared with Western diet , supporting its cardioprotective properties . The effect of the n-3 enriched diet was intermediate",
"BACKGROUND Despite the richness in antioxidants of the Mediterranean diet , to our knowledge , no r and omized controlled trials have assessed its effect on in vivo lipoprotein oxidation . METHODS A total of 372 subjects at high cardiovascular risk ( 210 women and 162 men ; age range , 55 - 80 years ) , who were recruited into a large , multicenter , r and omized , controlled , parallel-group clinical trial ( the Prevención con Dieta Mediterránea [ PREDIMED ] Study ) directed at testing the efficacy of the traditional Mediterranean diet ( TMD ) on the primary prevention of coronary heart disease , were assigned to a low-fat diet ( n = 121 ) or one of 2 TMDs ( TMD + virgin olive oil or TMD + nuts ) . The TMD participants received nutritional education and either free virgin olive oil for all the family ( 1 L/wk ) or free nuts ( 30 g/d ) . Diets were ad libitum . Changes in oxidative stress markers were evaluated at 3 months . RESULTS After the 3-month interventions , mean ( 95 % confidence intervals ) oxidized low-density lipoprotein ( LDL ) levels decreased in the TMD + virgin olive oil ( -10.6 U/L [ -14.2 to -6.1 ] ) and TMD + nuts ( -7.3 U/L [ -11.2 to -3.3 ] ) groups , without changes in the low-fat diet group ( -2.9 U/L [ -7.3 to 1.5 ] ) . Change in oxidized LDL levels in the TMD + virgin olive oil group reached significance vs that of the low-fat group ( P = .02 ) . Malondialdehyde changes in mononuclear cells paralleled those of oxidized LDL . No changes in serum glutathione peroxidase activity were observed . CONCLUSIONS Individuals at high cardiovascular risk who improved their diet toward a TMD pattern showed significant reductions in cellular lipid levels and LDL oxidation . Results provide further evidence to recommend the TMD as a useful tool against risk factors for CHD . Trial Registration is rct n.org Identifier : IS RCT N35739639",
"Objective : To determine the serum cholesterol , apolipoproteins and LDL oxidizability in young Japanese women and men during walnut consumption and to evaluate its active principle . Design : Experimental study with a r and omized design .Subjects : Twenty healthy women and 20 healthy men . Interventions : Subjects were r and omly assigned to consume each of two mixed natural diets for 4 weeks in a cross-over design . Reference and walnut diets were design ed and the walnut diet had 12.5 % of the energy derived from walnuts ( 44–58 g/day ) . Results : The total cholesterol and serum apolipoprotein B concentrations , and the ratio of LDL cholesterol to HDL cholesterol was significantly lowered in women and men when fed on the walnut diet , than when on the reference diet ( P≤0.05 ) . The LDL cholesterol concentration was significantly lowered in women on the walnut diet ( 0.22 mmol/l , P=0.0008 ) , whereas this decrease was not significant in men ( 0.18 mmol/l , P=0.078 ) . The most prominent change in the fatty acid composition of the cholesteryl esters from serum after the walnut diet was an elevation of α-linolenic acid in women ( 76 % , P change in LDL cholesterol in women ( r=0.496 , P=0.019 ) and men ( r=0.326 , P=0.138 ) . The LDL oxidizability in women was not influenced by the diets ( P=0.19 ) . Conclusions : α-Linolenic acid in the walnut diet appears to be responsible for the lowering of LDL cholesterol in women . Sponsorship : Kyushu University ( Fukuoka , Japan ) and the California Walnut Commission ( California , USA )",
"Objective : To compare two low fat diets one rich in walnuts on parameters of lipid metabolism in a group of hyperlipidaemic subjects . Design : A r and omised cross over study . Setting : Department of Human Nutrition , University of Otago , Dunedin , New Zeal and Subjects : Twenty one men with mean ( s.d ) levels of total and LDL cholesterol of 6.58 ( 0.60 ) and 4.63 ( 0.58 ) respectively . Interventions : For two periods of four weeks subjects were asked to consume two low fat diets ( fat 30 % total energy ) , one containing , on average , 78 g/d walnuts . Walnuts obtained through Lincoln University and the Walnut Growers Group ( South Canterbury ) . Results : Participants reported a higher total fat intake on the walnut diet ( 38 % compared with 30 % on the low fat diet P fatty acid profile of triacylglycerol , phospholipid and cholesterol ester on the walnut diet was a significant ( P acid . Triacylglycerol linolenate also increased significantly ( P Total and LDL cholesterol were lower on both experimental diets than at baseline , 0.25 mmol/l and 0.36 mmol/l respectively on the walnut diet and 0.13 mmol/l and 0.20 mmol/l respectively on the low fat diet . High density lipoprotein cholesterol was higher on both the walnut and low fat diets when compared to baseline ( 0.15 mmol/l and 0.12 mmol/l , respectively ) . When comparing the walnut and low fat diets only apo B was significantly lower ( P apolipoprotein B suggests a reduction in lipoprotein mediated risk , the relatively low myristic acid content of both diets perhaps explaining the absence of more extensive differences in lipoprotein levels on the two diets . Sponsorship : Nutrition Department University of Otago , New Zeal and",
"OBJECTIVE The aim of this study was to examine the effect of a moderate-fat diet inclusive of walnuts on blood lipid profiles in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS This was a parallel r and omized controlled trial comparing three dietary advice groups each with 30 % energy as fat : low fat , modified low fat , and modified low fat inclusive of 30 g of walnuts per day . Fifty-eight men and women , mean age 59.3 + /- 8.1 years , started the trial . Dietary advice was given at baseline with monthly follow-up and fortnightly phone calls for support . Body weight , percent body fat , blood lipids , HbA1c , total antioxidant capacity , and erythrocyte fatty acid levels were measured at 0 , 3 , and 6 months . Data were assessed by repeated- measures ANOVA with an intention-to-treat model . RESULTS The walnut group achieved a significantly greater increase in HDL cholesterol-to-total cholesterol ratio ( P=0.049 ) and HDL ( P=0.046 ) than the two other treatment groups . A 10 % reduction in LDL cholesterol was also achieved in the walnut group , reflecting a significant effect by group ( P=0.032 ) and time ( P=0.036 ) . There were no significant differences between groups for changes in body weight , percent body fat , total antioxidant capacity , or HbA1c levels . The higher dietary polyunsaturated fat-to-saturated fat ratio and intakes of omega-3 fatty acids in the walnut group were confirmed by erythrocyte biomarkers of dietary intake . CONCLUSIONS Structured \" whole of diet \" advice that included 30 g of walnuts/day delivering substantial amounts of polyunsaturated fatty acid improved the lipid profile of patients with type 2 diabetes",
"Studies consistently show the beneficial effects of eating nuts , but as high-energy foods , their regular consumption may lead to weight gain . We tested if daily consumption of walnuts ( approximately 12 % energy intake ) for 6 months would modify body weight and body composition in free-living subjects . Ninety participants in a 12-month r and omized cross-over trial were instructed to eat an allotted amount of walnuts ( 28 - 56 g ) during the walnut-supplemented diet and not to eat them during the control diet , with no further instruction . Subjects were unaware that body weight was the main outcome . Dietary compliance was about 95 % and mean daily walnut consumption was 35 g during the walnut-supplemented diet . The walnut-supplemented diet result ed in greater daily energy intake ( 557 kJ ( 133 kcal ) ) , which should theoretically have led to a weight gain of 3.1 kg over the 6-month period . For all participants , walnut supplementation increased weight ( 0.4 ( se 0.1 ) kg ) , BMI ( 0.2 ( se 0.1 ) kg/m(2 ) ) , fat mass ( 0.2 ( se 0.1 ) kg ) and lean mass ( 0.2 ( se 0.1 ) kg ) . But , after adjusting for energy differences between the control and walnut-supplemented diets , no significant differences were observed in body weight or body composition parameters , except for BMI ( 0.1 ( se 0.1 ) kg/m(2 ) ) . The weight gain from incorporating walnuts into the diet ( control-->walnut sequence ) was less than the weight loss from withdrawing walnuts from the diet ( walnut-->control sequence ) . Our findings show that regular walnut intake result ed in weight gain much lower than expected and which became non-significant after controlling for differences in energy intake",
"Objective : To compare the lipid-altering effect of roasted salted almonds and roasted almond butter with that of raw almonds , as part of a plant-based diet . Methods : Thirty-eight free-living , hypercholesterolemic men ( n = 12 ) and women ( n = 26 ) with a mean total serum cholesterol ( TC ) of 245 + 29 mg/dL ( mean + SD ) followed a heart-healthy diet including 100 g of one of three forms of almonds : roasted salted almonds , roasted almond butter or raw almonds for four weeks . Measurements of serum TC , triglycerides ( TG ) , selected lipoproteins and blood pressure were taken at baseline and after four weeks . Results : All three forms of almonds in the context of a heart-healthy diet significantly lowered low-density lipoprotein-cholesterol ( LDL ) from baseline to the completion of the study . Both raw and roasted almonds significantly lowered TC , whereas the decrease by almond butter ( in a smaller cohort ) did not reach statistical significance . High-density lipoprotein-cholesterol ( HDL ) did not significantly change with raw or roasted almonds but slightly increased with almond butter . At the end of the study , blood pressure did not change significantly from baseline values for any of the groups . Conclusion : These results suggest that unblanched almonds — whether raw , dry roasted , or in roasted butter form — can play an effective role in cholesterol-lowering , plant-based diets",
"Serum components , such as lipoproteins , coagulation factors ( factor VII , tissue plasminogen activator ( tPA ) , plasminogen activator inhibitor-1 ( PAI-1 ) , fibrinogen ) , and homocysteine have been associated with cardiovascular disease . Dietary intervention with a low-fat , low-cholesterol diet has favorably influenced cardiovascular disease and certain food , specifically the consumption of nuts , has been associated with reduced cardiovascular risks . The effects of walnuts , as part of a low-fat , low-cholesterol diet , on serum cardiovascular risk factors were determined . Sixty-seven ( 67 ) out patients with borderline high total cholesterol following a low-fat , low-cholesterol diet for six weeks before being r and omly assigned to continue the diet or have 64 grams/day of walnuts in conjunction with the diet . After six weeks , the patients ' diets were switched . Therefore , all patients consumed 64 grams/day of walnuts for six weeks during part of the trial as part of a low-fat , low cholesterol diet . Serum lipids demonstrated a significant reduction in triacyglycerols and favorable trend with decreases in total cholesterol , low-density lipoprotein ( LDL ) cholesterol , and a slight increase in high-density lipoprotein ( HDL ) cholesterol . No statistical effects on homocysteine or the coagulation factors were observed . However , there was a slight favorable trend for tPA and PAI-1 . This study demonstrated that walnuts , when consumed as part of a low fat , low-cholesterol diet , have a beneficial effect on serum cardiovascular risk factors . However , these changes may not explain all of the beneficial effects that walnut consumption has on cardiovascular disease",
"BACKGROUND In a recent six-year follow-up study , we found that frequent consumption of nuts was associated with a reduced risk of ischemic heart disease . To explore possible explanations for this finding , we studied the effects of nut consumption on serum lipids and blood pressure . METHODS We r and omly placed 18 healthy men on two mixed natural diets , each diet to be followed for four weeks . Both diets conformed to the National Cholesterol Education Program Step 1 diet and contained identical foods and macronutrients , except that 20 percent of the calories of one diet ( the walnut diet ) were derived from walnuts ( offset by lesser amounts of fatty foods , meat , and visible fat [ oils , margarine , and butter ] ) . RESULTS With the reference diet , the mean ( + /- SD ) serum values for total , low-density lipoprotein ( LDL ) , and high-density lipoprotein ( HDL ) cholesterol were , respectively , 182 + /- 23 , 112 + /- 16 , and 47 + /- 11 mg per deciliter ( 4.71 + /- 0.59 , 2.90 + /- 0.41 , and 1.22 + /- 0.28 mmol per liter ) . With the walnut diet , the mean total cholesterol level was 22.4 mg per deciliter ( 0.58 mmol per liter ) lower than the mean level with the reference diet ( 95 percent confidence interval , 28 to 17 mg per deciliter [ 0.72 to 0.44 mmol per liter ] ) ; the LDL and HDL cholesterol levels were , respectively , 18.2 mg per deciliter ( 0.47 mmol per liter ) ( P total , LDL , and HDL cholesterol , respectively . The ratio of LDL cholesterol to HDL cholesterol was also lowered ( P . Mean blood-pressure values did not change during either dietary period . CONCLUSIONS Incorporating moderate quantities of walnuts into the recommended cholesterol-lowering diet while maintaining the intake of total dietary fat and calories decreases serum levels of total cholesterol and favorably modifies the lipoprotein profile in normal men . The long-term effects of walnut consumption and the extension of this finding to other population groups deserve further study",
"Background : A number of recent studies indicate that antioxidants reduce the oxidative stress associated with the development of coronary heart diseases ( CHD ) . Objective : ( i ) To investigate whether the erythrocyte catalase ( CAT ) , superoxide dismutase ( SOD ) , total glutathione , reduced glutathione ( GSH ) , oxidized glutathione ( GSSG ) , and lipid peroxidation ( LPO ) , and serum uric acid and paraoxonase-1 ( PON1 ) are modified at increased CHD-risk individuals consuming walnut-enriched meat ( WM ) , ( ii ) to evaluate whether these changes were influenced by basal serum cholesterol , body mass index or smoking habit . Design : The study was a non blinded , cross-over , placebo-controlled trial in which 22 volunteers ( 60 % overweight and 40 % obese ) with increased CHD-risk were r and omly assigned to receive WM or control meat ( CM ) during two different periods of 5 weeks . Results : A significant interaction time*treatment ( p enzymes and substrates tested except HDL-C , uric acid and LPO . The treatment significantly increased CAT activity , total glutathione and GSSG ( p total glutathione was found increasing at the end of the WM period in male but not changing in female . Total glutathione and GSH/GSSG ratio ( p Hypercholesterolemics presented higher uric acid ( p enzyme activities or substrate concentrations were different from those of normocholesterolemics . Conclusions : The WM tested appears to be a functional food as it improved the antioxidant status of increased CHD-risk volunteers . Despite its high energy content , it also appears adequate for overweight and obese people because did not exert negative effect upon body weight"
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OBJECTIVE To perform a systematic review and meta- analysis of r and omized , placebo-controlled trials to assess the effect of vitamin K supplementation on insulin sensitivity . DATA SOURCES MEDLINE , the Cochrane Library , CINAHL , Web of Science , Scopus , clinical trials.gov , and clinical trial results .org were search ed up to January 2017 . Reference lists of related papers were also scanned . STUDY SELECTION R and omized controlled trials were selected if they compared vitamin K supplementation with placebo or no treatment and reported homeostasis model assessment of insulin resistance , fasting plasma glucose , fasting plasma insulin , C-reactive protein , adiponectin , leptin , or interleukin-6 levels . DATA EXTRACTION Data extraction and study quality assessment were performed independently by two investigators using a st and ardized data extraction form . Any inconsistencies were resolved by a third review er . Effect estimates were pooled using inverse-variance weighted method . Heterogeneity was assessed by the I2 and Q statistic . RESULTS A total of eight trials involving 1,077 participants met the inclusion criteria . A wide variety of participants were enrolled , including older men , postmenopausal women , prediabetic premenopausal women , and participants with a history of diabetes , hypertension , or vascular disease . Vitamin K1 and vitamin K2 ( MK-4 and MK-7 subtypes ) were assessed . Supplementation period ranged from 4 weeks to 3 years . Vitamin K supplementation did not affect insulin sensitivity as measured by homeostasis model assessment of insulin resistance , fasting plasma glucose , fasting plasma insulin , C-reactive protein , adiponectin , leptin , and interleukin-6 levels . CONCLUSION Our analysis suggests no effect of vitamin K supplementation on insulin sensitivity
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"Osteocalcin is the most abundant noncollagenous protein of bone matrix . Once transcribed , this protein undergoes posttranslational modifications within osteoblastic cells before its secretion , including the carboxylation of three glutamic residues in glutamic acid , which is essential for hydroxyapatite binding and deposition in the extracellular matrix of bone . Recent provocative data from experimental observations in mice showed that the circulating undercarboxylated fraction of osteocalcin increases insulin secretion and sensitivity , lowers blood glucose , and decreases visceral fat in both genders , while it enhances testosterone production by the testes in males . Moreover , both total and undercarboxylated osteocalcins increase following physical activity with potential positive effects on glucose tolerance . Despite that these evidence s have been only in part confirmed in humans , further prospect i ve investigations are needed to definitively establish the endocrine role of osteocalcin both in the general population and cohorts of patients with diabetes or other metabolic disorders",
"Adiponectin , the most abundant adipose-specific protein , has been found to be negatively associated with degree of adiposity and positively associated with insulin sensitivity in Pima Indians and other population s. Moreover , adiponectin administration to rodents has been shown to increase insulin-induced tyrosine phosphorylation of the insulin receptor ( IR ) and also increase whole-body insulin sensitivity . To further characterize the relationship between plasma adiponectin concentration and insulin sensitivity in humans , we examined 1 ) the cross-sectional association between plasma adiponectin concentration and skeletal muscle IR tyrosine phosphorylation and 2 ) the prospect i ve effect of plasma adiponectin concentration at baseline on change in insulin sensitivity . Fasting plasma adiponectin concentration , body composition ( hydrodensitometry or dual energy X-ray absorptiometry ) , insulin sensitivity ( insulin-stimulated glucose disposal , hyperinsulinemic clamp ) , and glucose tolerance ( 75-g oral glucose tolerance test ) were measured in 55 Pima Indians ( 47 men and 8 women , aged 31 + /- 8 years , body fat 29 + /- 8 % [ mean + /- SD ] ; 50 with normal glucose tolerance , 3 with impaired glucose tolerance , and 2 with diabetes ) . Group 1 ( 19 subjects ) underwent skeletal muscle biopsies for the measurement of basal and insulin-stimulated tyrosine phosphorylation of the IR ( stimulated by 100 nmol/l insulin ) . The fold increase after insulin stimulation was calculated as the ratio between maximal and basal phosphorylation . Group 2 ( 38 subjects ) had follow-up measurements of insulin-stimulated glucose disposal . Cross-sectionally , plasma adiponectin concentration was positively associated with insulin-stimulated glucose disposal ( r = 0.58 , P percent body fat ( r = -0.62 , P plasma adiponectin was negatively associated with the basal ( r = -0.65 , P = 0.003 ) and positively associated with the fold increase in IR tyrosine phosphorylation ( r = 0.69 , P = 0.001 ) before and after the adjustment for percent body fat ( r = -0.58 , P = 0.01 and r = 0.54 , P = 0.02 , respectively ) . Longitudinally , after adjustment for age , sex , and percent body fat , low plasma adiponectin concentration at baseline was associated with a decrease in insulin sensitivity ( P = 0.04 ) . In conclusion , our cross-sectional data suggest a role of physiological concentration of fasting plasma adiponectin in the regulation of skeletal muscle IR tyrosine phosphorylation . Prospect ively , low plasma adiponectin concentration at baseline precedes a decrease in insulin sensitivity . Our data indicate that adiponectin plays an important role in regulation of insulin sensitivity in humans",
"Background and Aims Vitamin K insufficiency is common and linked to an increased risk of cardiovascular disease and osteoporotic fractures . The aim of this study was to examine whether daily supplementation with oral vitamin K could improve vascular health and physical function in older people with established vascular disease . Methods and results A double blind , r and omised , placebo-controlled trial . Participants aged ≤ 70 years with a history of vascular disease were r and omised to receive 6 months of daily oral 100mcg vitamin K2 ( MK7 subtype ) or matching placebo with outcomes measured at 0 , 3 and 6 months . The primary outcome was between-group difference in endothelial function assessed using flow-mediated dilatation of the brachial artery at 6 months . Secondary outcomes included carotid-radial pulse wave velocity , augmentation index , blood pressure , carotid intima-media thickness , C-reactive protein , B-type natriuretic peptide , cholesterol and desphospho-uncarboxylated matrix Gla protein levels . H and grip strength and the Short Physical Performance Battery assessed physical function , while postural sway was measured using a 3-dimensional force platform . Results 80 participants were r and omised , mean age 77 ( SD 5 ) years ; 44/80 were male . Vitamin K levels rose in the intervention arm compared to placebo ( + 48 pg/ml vs −6 pg/ml , p=0.03 ) at 6 months . Desphospho-uncarboxylated Matrix Gla protein levels fell in the intervention group compared to placebo at 6 months ( −130 [ SD 117 ] pmol/L vs + 13 [ SD 180 ] pmol/L , p seen in endothelial function ( between group difference −0.3 % [ 95%CI −1.3 to 0.8 ] , p=0.62 ) . A modest , non-significant improvement in pulse wave velocity was seen in the vitamin K group ( −0.8 m/s [ 95%CI −1.8 to 0.3 ] , p=0.15 ) while all other vascular and physical function outcomes unchanged . Conclusions Six months of vitamin K2 supplementation did not improve markers of vascular health or physical function in older patients with vascular disease",
"BACKGROUND Vitamin K modulates cytokines involved in bone turnover , including interleukin-6 ( IL-6 ) and osteoprotegerin in vitro . OBJECTIVE The objective of this study was to assess 1 ) associations between measures of vitamin K status [ plasma phylloquinone and serum percentage of undercarboxylated osteocalcin ( % ucOC ) ] and IL-6 , osteoprotegerin , and C-reactive protein ( CRP ) concentrations and 2 ) the effect of daily 500 mug phylloquinone supplementation for 3 y on cytokine concentrations . DESIGN Concentrations of IL-6 , osteoprotegerin , and CRP and bone mineral density ( BMD ) were measured at baseline and after 3 y of follow-up in 379 healthy men and women ( 60 - 81 y ; 58.5 % women ) participating in a r and omized trial that studied the effect of vitamin K supplementation on bone loss . RESULTS Cross-sectionally , plasma phylloquinone was inversely associated with IL-6 and CRP , whereas serum % ucOC was inversely associated with IL-6 . Osteoprotegerin was associated positively with plasma phylloquinone and inversely with % ucOC . No differences were observed in the 3-y change in IL-6 , osteoprotegerin , and CRP concentrations between participants who received phylloquinone supplementation and those who did not . Overall , no association was observed between the 3-y changes in circulating cytokines and BMD . CONCLUSIONS Poor vitamin K status was associated with high concentrations of cytokines involved in bone turnover , but vitamin K supplementation did not confer a decrease in cytokine concentrations . The healthy status of this cohort may explain a lack of effect of vitamin K supplementation on cytokine concentrations . This trial was registered with www . clinical trials.gov as NCT00183001",
"OBJECTIVE —Vitamin K has a potentially beneficial role in insulin resistance , but evidence is limited in humans . We tested the hypothesis that vitamin K supplementation for 36 months will improve insulin resistance in older men and women . RESEARCH DESIGN AND METHODS —This was an ancillary study of a 36-month , r and omized , double-blind , controlled trial design ed to assess the impact of supplementation with 500 μg/day phylloquinone on bone loss . Study participants were older nondiabetic men and women ( n = 355 ; aged 60–80 years ; 60 % women ) . The primary outcome of this study was insulin resistance as measured by homeostasis model assessment ( HOMA-IR ) at 36 months . Fasting plasma insulin and glucose were examined as the secondary outcomes . RESULTS —The effect of 36-month vitamin K supplementation on HOMA-IR differed by sex ( sex × treatment interaction P = 0.02 ) . HOMA-IR was statistically significantly lower at the 36-month visit among men in the supplement group versus the men in the control group ( P = 0.01 ) after adjustment for baseline HOMA-IR , BMI , and body weight change . There were no statistically significant differences in outcome measures between intervention groups in women . CONCLUSIONS —Vitamin K supplementation for 36 months at doses attainable in the diet may reduce progression of insulin resistance in older men",
"OBJECTIVE To investigate whether dietary phylloquinone and menaquinones intakes are related to risk of type 2 diabetes . RESEARCH DESIGN AND METHODS We used data from a prospect i ve cohort study in 38,094 Dutch men and women , aged 20–70 years . Dietary phylloquinone and menaquinones intakes were assessed using a vali date d food frequency question naire . Diabetes case patients were ascertained mainly via self-report and verified against medical records . RESULTS During 10.3 years of follow-up , 918 incident cases of diabetes were documented . In a multivariate model adjusting for diabetes risk factors and dietary factors , phylloquinone intake tended to be associated ( P = 0.08 ) with a reduced risk of type 2 diabetes with a hazard ratio ( HR ) of 0.81 ( 95 % CI 0.66–0.99 ) for the highest versus the lowest quartile . For menaquinones intake , a linear , inverse association ( P = 0.038 ) with risk of type 2 diabetes was observed with an HR of 0.93 ( 0.87–1.00 ) for each 10-μg increment in the multivariate model . CONCLUSIONS This study shows that both phylloquinone and menaquinones intakes may be associated with a reduced risk of type 2 diabetes",
"Background Vitamin K , as a cofactor in the gamma carboxylation of certain glutamic acid ( Gla ) residues , has been related to glucose metabolism and insulin sensitivity . Osteocalcin , also known as bone γ-carboxyglutamic acid , increases β-cell proliferation as well as insulin and adiponectin secretion , which improve glucose tolerance and insulin sensitivity . Thus , the purpose of the present study was to examine the possible role of adiponectin as a mediator of glucose homeostasis following phylloquinone supplementation in premonopause women with prediabetes . Methods Eighty two women were r and omized to consume vitamin k1 supplement ( n = 39 ) or placebo ( n = 43 ) for four weeks . Participants in vitamin K1 treatment group received one pearl softgel capsule containing 1000 micrograms phylloquinone while the placebo group received one placebo capsules daily for four weeks . The Blood sample s were collected at baseline and after a four-week intervention to quantify osteocalcin , adiponectin , leptin and relevant variables . Results Phylloquinone supplementation significantly increased serum adiponectin concentration ( 1.24 ± 1.90 compared with −0.27 ± 1.08 μg/ml ) , and did not alter total osteocalcin ( 0.50 ± 4.11 compared with 0.13 ± 1.85 ng/ml ) and leptin ( −0.29 ± 8.23 compared with −1.15 ± 5.25 ng/ml ) compared with placebo . Adjustments for total osteocalcin and adiponectin using analysis of covariance ( ANCOVA ) did not affect the association of glycemic status with related variables . Conclusions In conclusion our study demonstrated that phylloquinone supplementation improved glycemic status in premonopausal prediabetic women independent of adiponectin . Trial registration This trial was registered in Iranian Registry of Clinical Trials with ID number of I RCT 2013120915724N1",
"CONTEXT AND OBJECTIVE Because it has been suggested that osteocalcin ( OC ) , an osteoblast-derived hormone , is a new link between bone and glucose metabolism , we tested whether serum carboxylated osteocalcin ( cOC ) and undercarboxylated osteocalcin ( ucOC ) levels are independently associated with the development of type 2 diabetes in subjects at high cardiovascular risk . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve , nested case-control study was conducted using data from the Prevención con Dieta Mediterránea ( PREDIMED ) study . We included 153 case subjects with newly diagnosed diabetes and 306 individually matched control subjects free of diabetes identified during a mean 5-year follow-up . Conditional logistic regression models were used to estimate matched odds ratios for incident diabetes according to categories of both forms of OC measured by ELISAs . RESULTS Baseline serum concentrations of both forms of OC were significantly lower in case subjects than in control subjects . In subjects with incident cases of diabetes , concentrations of cOC , but not of ucOC , were inversely and significantly associated with homeostasis model assessment of insulin resistance levels ( β = -0.335 ) and with fasting glucose concentrations ( β = -0.044 ) in control subjects , independent of other relevant confounders . In the conditional logistic model that took into account the matching factors , the odds ratios for diabetes incidence in the lowest vs the highest tertile of cOC and ucOC were 2.03 ( 95 % confidence interval , 1.32 - 3.13 ) and 1.88 ( 1.23 - 2.85 ) , respectively . Further adjustment for family history of diabetes , lifestyle , and other confounding factors did not appreciably change the magnitude of these associations . CONCLUSION In a population at high cardiovascular risk , low concentrations of serum cOC and ucOC were strongly associated with an increased risk of incident diabetes ",
"Background / Objectives : A relationship between osteocalcin ( OC ) levels and factors associated with energy metabolism and insulin resistance has been reported recently . The aim of this study was to investigate whether modulation of ostecalcin isoforms via vitamin K1 supplementation would affect glucose metabolism or insulin sensitivity in prediabetic and premenopause women . Subjects/ Methods : Eighty-two prediabetic women were r and omized to consume vitamin K1 supplement ( n=39 ) or placebo ( n=43 ) for 4 weeks . Participants in the vitamin K1 supplement group received one pearl softgel capsule containing 1000 μm of phylloquinone , and the placebo group received one placebo capsule daily for 4 weeks . Blood sample s were collected at baseline and after the 4-week intervention period to quantify carboxylated OC ( cOC ) , undercarboxylated OC ( ucOC ) and relevant variables . Results : Phylloquinone supplementation increased the serum levels of cOC and decreased ucOC , compared with placebo ( 12.53±5.95 compared with 7.43±4.85 ng/ml and 2.47±1.91 compared with 4.79±2.43 ng/ml , respectively ; P of phylloquinone supplement led to significant decreases in % ucOC ( 17.97±12.24 compared with 43.80±19.86 ) and 2-h post-oral glucose tolerance test ( OGTT ) glucose ( 7.32±1.50 compared with 8.62±1.45 mmol/l ) , and 2- h post-OGTT insulin level ( 80.34±42.24 compared with 112.43±53.19 μIU/ml ) and increased insulin sensitivity index ( 2.46±0.71 compared with 1.75±0.61 ) compared with placebo . Overall , a significant association was found between changes in % ucOC and changes in 2-h post-OGTT glucose ( r=0.308 , P=0.028 ) . Conclusions : The results of this study demonstrated that vitamin K1 supplementation for 4 weeks did not affect insulin resistance in premenopausal and prediabetic women but had beneficial effects on glycemic status and insulin sensitivity",
"Background Cardiovascular disease is the major cause of death in the Western world , but some recent studies indicate that vitamin K may play a role in atherosclerosis protection . Aim of study The aim of this study was to evaluate the effect of phylloquinone supplementation on blood lipids , inflammatory markers and fibrinolytic activity in postmenopausal women . Methods Thirty-one postmenopausal women completed this placebo-controlled , r and omized crossover study and received 500 µg phylloquinone or placebo in addition to their habitual diet during two periods of 6 weeks ’ duration . Blood concentration of lipids , inflammatory markers and fibrinolytic parameters were measured after each period . Results Inflammatory markers , fibrinolytic parameters , total cholesterol and LDL-C were unaffected by the supplementation , whereas a 15 % increase was seen in triacylglycerols ( P = 0.015 ) and a 5 % decrease in HDL-C ( P = 0.06 ) . Conclusions Six weeks supplementation with a dose of phylloquinone similar to that obtainable from the diet induced a deterioration of the lipid profile with no improvement in any of the other risk markers analysed . Thus , these results do not support a cardioprotective effect of vitamin K as has been suggested by others"
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411733a4-06ff-11f0-808a-c43d1ab1c353
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OBJECTIVES To improve the evaluation of the possible antiarrhythmic effect of statins , we performed a meta- analysis of r and omized trials with statins on the end point of incidence or recurrence of atrial fibrillation ( AF ) . BACKGROUND The use of statins had been suggested to protect against AF in some clinical observational and experimental studies but has remained inadequately explored . METHODS A systematic review of controlled trials with statins was performed . Eligible studies had to have been r and omized controlled parallel- design human trials with use of statins that collected data on incidence or recurrence of AF . RESULTS Six studies with 3,557 patients in sinus rhythm were included in the analysis . Three studies investigated the use of statins in patients with a history of paroxysmal AF ( n = 1 ) or persistent AF undergoing electrical cardioversion ( n = 2 ) , and 3 investigated the use of statins in primary prevention of AF in patients undergoing cardiac surgery or after acute coronary syndrome . Incidence or recurrence of AF occurred in 386 patients . Overall , the use of statins was significantly associated with a decreased risk of AF compared with control ( odds ratio [ OR ] 0.39 , 95 % confidence interval [ CI ] 0.18 to 0.85 , p = 0.02 ) . Benefit of statin therapy seemed more marked in secondary prevention of AF ( OR 0.33 , 95 % CI 0.10 to 1.03 , p = 0.06 ) than for new-onset or postoperative AF ( OR 0.60 , 95 % CI 0.27 to 1.37 , p = 0.23 ) . CONCLUSIONS Use of statins was significantly associated with a decreased risk of incidence or recurrence of AF in patients in sinus rhythm with a history of previous AF or undergoing cardiac surgery or after acute coronary syndrome
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"Background —Inflammation promotes acute coronary syndromes and ensuing clinical complications . Although statins reduce inflammatory markers in asymptomatic adults or in patients with stable angina , the effect of statins on the markedly heightened inflammation in patients with acute coronary syndromes is unknown . Methods and Results —We measured C-reactive protein ( CRP ) , serum amyloid A ( SAA ) , and interleukin 6 ( IL-6 ) in 2402 subjects enrolled the Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering ( MIRACL ) study . Subjects with unstable angina or non – Q-wave myocardial infa rct ion were r and omized to atorvastatin 80 mg/d or placebo within 24 to 96 hours of hospital admission and treated for 16 weeks . The effect of treatment on inflammatory markers was assessed by ANCOVA after adjustment for presenting syndrome , country , and initial level of marker . All 3 markers were markedly elevated at r and omization and declined over the 16 weeks in both treatment groups . Compared with placebo , atorvastatin significantly reduced CRP , −83 % ( 95 % CI , −84 % , −81 % ) versus −74 % ( 95 % CI , −75 % , −71 % ) ( P , −80 % ( 95 % CI , −82 % , −78 % ) versus −77 % ( −79 % , −75 % ) ( P = 0.0006 ) but not IL-6 , −55 % ( 95 % CI , −57 % , −53 % ) versus −53 % ( 95 % CI , −55 % , −51 % ) ( P = 0.3 ) . Reductions in CRP and SAA were observed in patients with unstable angina and non – Q-wave myocardial infa rct ion , with initial LDL cholesterol and in men and women . By 16 weeks , CRP was 34 % lower with atorvastatin than with placebo . Conclusions —High-dose atorvastatin potentiated the decline in inflammation in patients with acute coronary syndromes . This supports the value of early statin therapy in these patients",
"CONTEXT Atrial fibrillation is a common , but potentially preventable , complication following coronary artery bypass graft ( CABG ) surgery . OBJECTIVES To assess the nature and consequences of atrial fibrillation after CABG surgery and to develop a comprehensive risk index that can better identify patients at risk for atrial fibrillation . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve observational study of 4657 patients undergoing CABG surgery between November 1996 and June 2000 at 70 centers located within 17 countries , selected using a systematic sampling technique . From a derivation cohort of 3093 patients , associations between predictor variables and postoperative atrial fibrillation were identified to develop a risk model , which was assessed in a validation cohort of 1564 patients . MAIN OUTCOME MEASURE New-onset atrial fibrillation after CABG surgery . RESULTS A total of 1503 patients ( 32.3 % ) developed atrial fibrillation after CABG surgery . Postoperative atrial fibrillation was associated with subsequent greater re source use as well as with cognitive changes , renal dysfunction , and infection . Among patients in the derivation cohort , risk factors associated with atrial fibrillation were advanced age ( odds ratio [ OR ] for 10-year increase , 1.75 ; 95 % confidence interval [ CI ] , 1.59 - 1.93 ) ; history of atrial fibrillation ( OR , 2.11 ; 95 % CI , 1.57 - 2.85 ) or chronic obstructive pulmonary disease ( OR , 1.43 ; 95 % CI , 1.09 - 1.87 ) ; valve surgery ( OR , 1.74 ; 95 % CI , 1.31 - 2.32 ) ; and postoperative withdrawal of a beta-blocker ( OR , 1.91 ; 95 % CI , 1.52 - 2.40 ) or an angiotensin-converting enzyme ( ACE ) inhibitor ( OR 1.69 ; 95 % CI , 1.38 - 2.08 ) . Conversely , reduced risk was associated with postoperative administration of beta-blockers ( OR , 0.32 ; 95 % CI , 0.22 - 0.46 ) , ACE inhibitors ( OR , 0.62 ; 95 % CI , 0.48 - 0.79 ) , potassium supplementation ( OR , 0.53 ; 95 % CI , 0.42 - 0.68 ) , and nonsteroidal anti-inflammatory drugs ( OR , 0.49 ; 95 % CI , 0.40 - 0.60 ) . The result ing multivariable risk index had adequate discriminative power with an area under the receiver operating characteristic ( ROC ) curve of 0.77 in the validation sample . Forty-three percent ( 640/1503 ) of patients who had atrial fibrillation after CABG surgery experienced more than 1 episode of atrial fibrillation . Predictors of recurrent atrial fibrillation included older age , history of congestive heart failure , left ventricular hypertrophy , aortic atherosclerosis , bicaval venous cannulation , withdrawal of ACE inhibitor or beta-blocker therapy , and use of amiodarone or digoxin ( area under the ROC curve of 0.66 ) . Patients with recurrent atrial fibrillation had longer hospital stays and experienced greater infectious , renal , and neurological complications than those with a single episode . CONCLUSIONS We have developed and vali date d models predicting the occurrence of atrial fibrillation after CABG surgery based on an analysis of a large multicenter international cohort . Our findings suggest that treatment with beta-blockers , ACE inhibitors , and /or nonsteroidal anti-inflammatory drugs may offer protection . Atrial fibrillation after CABG surgery is associated with important complications",
"Background — Atrial fibrillation ( AF ) after cardiac surgery is associated with increased risk of complications , length of stay , and cost of care . Observational evidence suggests that patients who have undergone previous statin therapy have a lower incidence of postoperative AF . We tested this observation in a r and omized , controlled trial . Methods and Results — Two hundred patients undergoing elective cardiac surgery with cardiopulmonary bypass , without previous statin treatment or history of AF , were enrolled . Patients were r and omized to atorvastatin ( 40 mg/d , n=101 ) or placebo ( n=99 ) starting 7 days before operation . The primary end point was incidence of postoperative AF ; secondary end points were length of stay , 30-day major adverse cardiac and cerebrovascular events , and postoperative C-reactive protein ( CRP ) variations . Atorvastatin significantly reduced the incidence of AF versus placebo ( 35 % versus 57 % , P=0.003 ) . Accordingly , length of stay was longer in the placebo versus atorvastatin arm ( 6.9±1.4 versus 6.3±1.2 days , P=0.001 ) . Peak CRP levels were lower in patients without AF ( P=0.01 ) , irrespective of r and omization assignment . Multivariable analysis showed that atorvastatin treatment conferred a 61 % reduction in risk of AF ( odds ratio 0.39 , 95 % confidence interval 0.18 to 0.85 , P=0.017 ) , whereas high postoperative CRP levels were associated with increased risk ( odds ratio 2.0 , 95 % confidence interval 1.2 to 7.0 , P=0.01 ) . The incidence of major adverse cardiac and cerebrovascular events at 30 days was similar in the 2 arms . Conclusions — Treatment with atorvastatin 40 mg/d , initiated 7 days before surgery , significantly reduces the incidence of postoperative AF after elective cardiac surgery with cardiopulmonary bypass and shortens hospital stay . These results may influence practice patterns with regard to adjuvant pharmacological therapy before cardiac surgery",
"CONTEXT Patients experience the highest rate of death and recurrent ischemic events during the early period after an acute coronary syndrome , but it is not known whether early initiation of treatment with a statin can reduce the occurrence of these early events . OBJECTIVE To determine whether treatment with atorvastatin , 80 mg/d , initiated 24 to 96 hours after an acute coronary syndrome , reduces death and nonfatal ischemic events . DESIGN AND SETTING A r and omized , double-blind trial conducted from May 1997 to September 1999 , with follow-up through 16 weeks at 122 clinical centers in Europe , North America , South Africa , and Australasia . PATIENTS A total of 3086 adults aged 18 years or older with unstable angina or non-Q-wave acute myocardial infa rct ion . INTERVENTIONS Patients were stratified by center and r and omly assigned to receive treatment with atorvastatin ( 80 mg/d ) or matching placebo between 24 and 96 hours after hospital admission . MAIN OUTCOME MEASURES Primary end point event defined as death , nonfatal acute myocardial infa rct ion , cardiac arrest with resuscitation , or recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization . RESULTS A primary end point event occurred in 228 patients ( 14.8 % ) in the atorvastatin group and 269 patients ( 17.4 % ) in the placebo group ( relative risk [ RR ] , 0.84 ; 95 % confidence interval [ CI ] , 0.70 - 1.00 ; P = .048 ) . There were no significant differences in risk of death , nonfatal myocardial infa rct ion , or cardiac arrest between the atorvastatin group and the placebo group , although the atorvastatin group had a lower risk of symptomatic ischemia with objective evidence and requiring emergency rehospitalization ( 6.2 % vs 8.4 % ; RR , 0.74 ; 95 % CI , 0.57 - 0.95 ; P = .02 ) . Likewise , there were no significant differences between the atorvastatin group and the placebo group in the incidence of secondary outcomes of coronary revascularization procedures , worsening heart failure , or worsening angina , although there were fewer strokes in the atorvastatin group than in the placebo group ( 12 vs 24 events ; P = .045 ) . In the atorvastatin group , mean low-density lipoprotein cholesterol level declined from 124 mg/dL ( 3.2 mmol/L ) to 72 mg/dL ( 1.9 mmol/L ) . Abnormal liver transaminases ( > 3 times upper limit of normal ) were more common in the atorvastatin group than in the placebo group ( 2.5 % vs 0.6 % ; P patients with acute coronary syndrome , lipid-lowering therapy with atorvastatin , 80 mg/d , reduces recurrent ischemic events in the first 16 weeks , mostly recurrent symptomatic ischemia requiring rehospitalization",
"BACKGROUND Previous prospect i ve outcome studies of statins have not provided any guidance on benefit-risk in patients with heart failure . AIM The primary objective is to determine whether rosuvastatin ( 10 mg ) reduces the combined endpoint of cardiovascular mortality , non-fatal myocardial infa rct ion or non-fatal stroke ( time to first event ) . The first secondary endpoint is all-cause mortality . METHODS CORONA is a r and omized , double-blind , placebo-controlled trial . Briefly , men and women , aged > or = 60 years with chronic symptomatic systolic heart failure of ischemic aetiology and ejection fraction cholesterol lowering drugs . RESULTS Mean age was 73 years ( n=5016 ; 24 % women ) , with 37 % in NYHA II and 62 % in NYHA III , ejection fraction 0.31 , total cholesterol 5.2 mmol/L. Sixty percent have a history of myocardial infa rct ion , 63 % hypertension , and 30 % diabetes . Patients are well treated for heart failure with 90 % on loop or thiazide diuretics , 42 % aldosterone antagonists , 91 % ACE inhibitor or AT-I blocker , 75 % beta-blockers , and 32 % digitalis . CONCLUSION CORONA is important for three main reasons : ( 1 ) A positive result is very important because of the high risk of the population studied , the increasing prevalence of elderly patients with chronic symptomatic systolic heart failure in our society , and the health economic issues involved . ( 2 ) If negative , new mechanistic questions about heart failure have to be raised . ( 3 ) If neutral we can avoid unnecessary polypharmacy",
"BACKGROUND C-reactive protein ( CRP ) lowering is associated with a reduction in recurrent and permanent atrial fibrillation . This study sought to determine whether CRP lowering also results in a reduction of paroxysmal atrial fibrillation ( PAF ) during daily life . METHODS AND RESULTS We enrolled 80 patients with proven PAF , CRP between 0.8 and 13 mg/L , and at least 1 episode of PAF on ambulatory electrocardiographic monitoring . Forty patients were r and omized to placebo ( placebo group ) and 40 to atorvastatin ( treatment group ) . Plasma CRP levels and ambulatory monitoring were repeated after 4 to 6 months of therapy . The 2 groups were comparable with respect to baseline characteristics , number of episodes of PAF , and baseline plasma CRP levels . The treatment group had lower median CRP levels at study end and experienced a significant reduction in the number of episodes of PAF compared with the placebo group . Paroxysmal atrial fibrillation was completely resolved in 26 ( 65 % ) of 40 patients in the treatment group versus 4 ( 10 % ) of 40 in the placebo group . The treatment group exhibited a highly significant reduction in PAF ( P atorvastatin was an independent predictor of PAF resolution . CONCLUSIONS C-reactive protein lowering with atorvastatin appears to be effective in eliminating PAF during daily life in a significant proportion of patients",
"To test the hypothesis that a statin could reduce the recurrence rate of atrial fibrillation after electrical cardioversion ( EC ) , we performed an open , controlled multicenter study . Patients ( n = 114 ) who had atrial fibrillation > 48 hours and who were scheduled for EC were r and omized to receive 40 mg of pravastatin once daily for 3 weeks before and 6 weeks after EC or no drug in addition to st and ard therapy . Pravastatin did not reduce the recurrence rate of atrial fibrillation after EC",
"To study the effect of atorvastatin on recurrence of atrial fibrillation ( AF ) after electrical cardioversion ( EC ) , 48 patients with AF lasting 48 hours who were scheduled for EC were r and omized to the atorvastatin ( group I ) and control ( group II ) groups . Six patients in group I ( 25 % ) and 2 patients in group II ( 8.3 % ) had spontaneous conversion before EC ( p > 0.05 ) . The end point was the recurrence of AF during 3 months of follow-up . Eighteen patients in group I ( 12.5 % ) and 11 patients in group II ( 45.8 % ) had recurrence ( p = 0.01 , log-rank test ) . With the Cox proportional model , the predictors of recurrence included a body mass index of 25 to 30 kg/m2 ( relative risk [ RR ] 0.07 , 95 % confidence interval [ CI ] 0.008 to 0.59 ) , body mass index > or = 30 kg/m2 ( RR 0.24 , 95 % CI 0.08 to 0.72 ) , AF duration of > or = 3 months ( RR 0.28 , 95 % CI 0.09 to 0.83 ) , diabetes mellitus ( RR 0.34 , 95 % CI 0.12 to 0.98 ) , and left atrial diameter of > or = 45 mm ( RR 0.23 , 95 % CI 0.07 to 0.74 ) . Atorvastatin was associated with a significantly reduced risk of developing AF ( unadjusted RR 0.23 , 95 % CI 0.064 to 0.82 , p = 0.024 ) . This association remained significant after adjustment for these predictors ( adjusted RR 0.19 , 95 % CI 0.052 to 0.72 , p = 0.01 ) . High-sensitivity C-reactive protein levels at baseline were not different between the 2 groups ( p = 0.92 ) . Although the high-sensitivity C-reactive protein levels decreased significantly 48 hours after EC compared with the baseline levels in group I ( 2.82 + /- 1.46 vs 2.56 + /- 1.3 mg/dl , p = 0.02 ) , no significant change occurred in group II ( 2.87 + /- 0.8 vs 2.84 + /- 0.8 mg/dl , p = 0.09 ) . In conclusion , atorvastatin decreased the recurrence rate of AF after EC",
"Objectives : Systemic inflammatory response occurs frequently after coronary artery bypass surgery , and it is strongly correlated with the risk of postoperative morbidity and mortality . Recent studies demonstrate that treatment with statin is associated with a significant and marked decrease in inflammation-associated variables such as the C-reactive protein , cytokines , and adhesion molecules . Therefore , we investigated the effects of preoperative atorvastatin treatment on systemic inflammatory response and perioperative morbidity after cardiopulmonary bypass . Design : Double-blinded , placebo-controlled , r and omized study . Setting : University hospital . Patients : Forty patients were r and omized to treatment with atorvastatin ( 20 mg/day , group A , n = 20 ) or placebo ( group B , n = 20 ) 3 wks before surgery . Interventions : Three-week treatment by atorvastatin 20 mg/day . Measurement and Main Results : Postoperative serum levels of both interleukin-6 and interleukin-8 increased significantly over baseline , but the peak levels observed 4 hrs postoperatively were significantly lower in the atorvastatin group . In the same fashion , CD11b expression on neutrophils was significantly lower in the statin group at 4 and 24 hrs postoperatively . Finally , neutrophil-endothelial adhesion was significantly reduced in the statin patients compared with controls . The operation time , blood loss , need for inotropic support , intubation time , and length of intensive care unit or hospital stay did not differ significantly between the two groups . The systemic inflammatory response syndrome score on postoperative days 1 and 2 was comparable in both groups . Conclusions : Pretreatment with atorvastatin significantly reduces cytokine release and neutrophil adhesion to the venous endothelium in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass"
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411733e0-06ff-11f0-808a-c43d1ab1c353
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BACKGROUND Biomarkers of iodine status are required to study iodine deficiency disorders in different parts of the world and to evaluate the effects of fortification strategies . OBJECTIVE The objective was to assess the usefulness of biomarkers of iodine status in humans by systematic ally review ing intervention studies that altered iodine status . DESIGN We performed a structured search for iodine intervention studies on Ovid MEDLINE , EMBASE ( Ovid ) , and the Cochrane Library . Studies were assessed for inclusion and validity , with independent duplication . A r and om-effects meta- analysis was performed . RESULTS Twenty-one intervention studies ( 12 r and omized controlled trials , 3 controlled clinical trials , and 6 before-after studies ) were included in the review . Urinary iodine ( in children and adolescents and in those with low and moderate baseline iodine status ) , thyroglobulin ( in children and adolescents but not in pregnant and lactating women ) , serum thyroxine ( in children and adolescents , adults , women , and those with moderate baseline thyroxine status but not in pregnant and lactating women ) , and serum thyroid-stimulating hormone ( in pregnant and lactating women but not in children and adolescents or those at moderate baseline status ) , but not triiodothyronine , proved to be useful biomarkers of iodine status . CONCLUSIONS Despite the high risk of bias of many of the included studies , the results suggested that urinary iodine , thyroglobin , serum thyroxine , and thyroid-stimulating hormone are useful biomarkers of iodine status , at least in some groups . High- quality controlled studies measuring relevant long-term outcomes are needed to address which biomarker is the most appropriate for assessing iodine intake in some population groups and setting
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"BACKGROUND Serum thyroglobulin appears to be a sensitive marker of thyroid dysfunction in endemic goiter . However , its value as an indicator of thyroid status in children after the introduction of iodized salt has not been tested . OBJECTIVE The objective was to optimize and vali date a thyroglobulin assay on dried whole blood spots and to evaluate thyroglobulin as an indicator of thyroid response to iodized salt . DESIGN A st and ardized , commercially available , s and wich fluoroimmunometric serum thyroglobulin assay was adapted for use on blood spots and vali date d in Swiss children . In a 1-y prospect i ve study in 377 goitrous Moroccan children aged 6 - 15 y , the assay was used to measure thyroglobulin before and after the introduction of iodized salt . Urinary iodine , thyroid volume , thyrotropin , and thyroxine were measured , and regression was done with thyroglobulin as the dependent variable . RESULTS Correlation between the blood spot and serum assays was excellent ( r = 0.98 ) . The SD of the difference between the blood spot and serum assays was 3.8 micro g/L ; the median CVs for the blood spot assay in controls and sample s were 6.3 % and 14.4 % , respectively . Median thyroglobulin was 24.5 ( range : 0 - 328.8 ) micro g/L at baseline and fell significantly after the introduction of iodized salt to 6.2 ( 0 - 83.1 ) and 4.4 ( 0 - 47.1 ) micro g/L at 5 and 12 mo , respectively ( P Regression of urinary iodine and thyroid volume on thyroglobulin was highly significant at baseline and at 5 mo ( P thyroid function in children after supplementation with iodized salt",
"Iodine deficiency control programs have greatly reduced iodine deficiency disorders worldwide . For monitoring changes in iodine status , different indicators may be used . The aim of this study was to evaluate the suitability of indicators of iodine status and thyroid function , thyroglobulin ( Tg ) , thyroid-stimulating hormone ( TSH ) and free thyroxine ( FT4 ) in serum , thyroid volume and urinary iodine concentration , in iodine-deficient schoolchildren under conditions of increasing iodine supply . The study was established as a double-blind , placebo-controlled oral administration of a single dose of iodized oil to schoolchildren ( 7 - 10 y old ) , living in an iodine-deficient area of Benin , with an observation period of 10 mo . However , 3 - 4 mo after supplementation , iodized salt became available in the area . The study population therefore comprised an iodized oil-supplemented group and a nonsupplemented group , both of which had variable , uncontrolled intakes of iodized salt during the last 6 mo of the study . Initial mean serum concentrations of TSH and FT4 were within the normal range , whereas serum Tg concentration , urinary iodine concentration and thyroid volume were indicative of moderate-to-severe iodine deficiency . At the end of the study , all indicators had improved significantly , except thyroid volume , which had decreased only in the supplemented group . The supplemented group also still had significantly lower serum Tg and higher urinary iodine concentrations than the nonsupplemented group . Serum Tg and urinary iodine concentrations are the indicators most influenced by a changing iodine supply . Current normal reference ranges of serum concentrations of TSH and FT4 are too wide for detecting iodine deficiency in this age group",
"BACKGROUND Infants are highly vulnerable to iodine deficiency , and little data exist on the effect of multiple micronutrient supplementation on their iodine status . OBJECTIVE We aim ed to compare the efficacy of daily and weekly multiple micronutrient food-like tablets ( foodLETs ) on increasing iodine status among infants . DESIGN In a double-blind , placebo-controlled trial , 133 Indonesian males aged 6 - 12 mo were r and omly assigned to 1 of 4 groups : a daily multiple-micronutrient foodLET providing the Recommended Nutrient Intake (RNI)(DMM ) , a weekly multiple-micronutrient foodLET providing twice the RNI ( WMM ) , a daily 10-mg Fe foodLET ( DI ) , or placebo . Urinary iodine ( UI ) concentrations were measured at baseline and at 23 wk . RESULTS At baseline , the average UI concentration ( 1.37 micromol/L ) was within the normal range , and 30.8 % of subjects had iodine deficiency ( UI DMM group had the highest increment in UI ; however , after adjustment for initial UI , the changes in UI were not significantly different between the 4 groups ( P = 0.39 ) . Initial UI correlated inversely with the changes in UI ( P proportion of iodine-deficient infants and in infants with iodine excess , respectively ; however , no significant difference was found in these proportions ( P = 0.13 and P = 0.42 ) between the 4 groups . CONCLUSION Daily consumption of a multiple-micronutrient foodLET providing the RNI during infancy may be one strategy to improve iodine status",
"Iodized salt and iodized oil are the main methods used to prevent iodine deficiency , but sometimes alternative approaches are needed . We tested the efficacy of various regimens for the intermittent administration of potassium iodide in Hwedza , Zimbabwe , an area of known severe iodine deficiency . We divided 304 schoolchildren aged 7 - 13 y into five equal groups that received iodine as a 10 % solution of potassium iodide as follows : 8.7 mg every 2 wk ( group A ) , 29.7 mg every month ( group B ) , 148.2 mg every 3 mo ( group C ) , 382 mg every 6 mo ( group D ) , or 993 mg once ( group E ) . The follow-up period was 13 mo . No adverse effects were encountered with any of these doses . After 6 mo , the median blood spot thyroglobulin concentration had decreased in all groups and had normalized in groups A and B to values found in iodine-sufficient population s. The number of children with elevated thyroid-stimulating hormone concentrations decreased in groups A-C , but the changes were not significant . Urine iodine concentration generally remained low in all groups but increased in group A. After 13 mo , mean thyroid volume measured by ultrasound had decreased in groups A and B to values comparable with those in iodine-sufficient areas , and was unchanged in the other groups . We conclude that oral potassium iodide is effective for the prophylaxis of iodine deficiency if given as a dose of 30 mg I monthly or 8 mg biweekly",
"BACKGROUND In developing countries , many children are at high risk of goiter and iron deficiency anemia . Because iron deficiency can have adverse effects on thyroid metabolism , iron deficiency may influence the response to supplemental iodine in areas of endemic goiter . OBJECTIVE The aim of this study was to determine whether goitrous children with iron deficiency anemia would respond to oral iodine supplementation . DESIGN A trial of oral iodine supplementation was carried out in an area of endemic goiter in western Côte d'Ivoire in goitrous children ( n = 109 ) aged 6 - 12 y. Group 1 ( n = 53 ) consisted of goitrous children who were not anemic . Group 2 ( n = 56 ) consisted of goitrous children who had iron deficiency anemia . At baseline , thyroid gl and volume and urinary iodine , thyrotropin , and thyroxine were measured by using ultrasound . Each child received 200 mg I orally and was observed for 30 wk , during which urinary iodine , thyrotropin , thyroxine , hemoglobin , and thyroid gl and volume were measured . RESULTS The prevalence of goiter at 30 wk was 12 % in group 1 and 64 % in group 2 . The mean percentage change from baseline in thyroid volume 30 wk after administration of oral iodine was -45.1 % in group 1 and -21.8 % in group 2 ( P thyroid volume and hemoglobin concentration ( r(2 ) = 0.65 ) . CONCLUSION The therapeutic response to oral iodine was impaired in goitrous children with iron deficiency anemia , suggesting that the presence of iron deficiency anemia in children limits the effectiveness of iodine intervention programs",
"Iodine supplementation before pregnancy in iodine-deficient women prevents cretinism and neuromotor deficits in their offspring . It is unclear whether iodine supplementation benefits cognitive function in iodine-deficient school-aged children . We therefore conducted a double-blind , r and omized , controlled trial of the effects of iodized poppy seed oil ( Lipiodol ) on cognitive and motor function and weight gain of iodine-deficient school children . The study was conducted with 305 children in grade s 1 and 2 from 10 primary schools in two iodine-deficient areas in Bangladesh . The children were stratified by school and grade and r and omly assigned to receive 400 mg of oral Lipiodol or a placebo . All children were given a battery of cognitive and motor function tests and had their weights , serum thyroxine ( T4 ) and thyroid-stimulating hormone ( TSH ) and urinary iodine levels measured before and 4 mo after the intervention . On enrollment , both groups were moderately iodine deficient ( median urinary iodine values : placebo group = 3.3 micromol/L , n = 148 ; iodine group = 3.1 micromol/L , n = 152 ; goiter prevalence in both groups > 95 % ) . However , their T4 and TSH levels were within the normal range . After 4 mo , there was a significant treatment effect on urinary iodine levels ( P T4 and TSH levels , weight gain , cognitive or motor function . The findings suggest that Lipiodol supplementation in moderately iodine-deficient children with normal T4 levels is unlikely to benefit their cognitive function . However , it remains possible that other iodine preparations may have benefits",
"BACKGROUND Iodine is required for the production of thyroid hormones , which are necessary for normal brain development and cognition . Although several r and omized trials examined the effect of iodine supplementation on cognitive performance in schoolchildren , the results were equivocal . OBJECTIVE We aim ed to ascertain whether providing iodized oil to iodine-deficient children would affect their cognitive and motor performance . DESIGN In a double-blind intervention trial , 10 - 12-y-old children ( n = 310 ) in primary schools in rural southeastern Albania were r and omly assigned to receive 400 mg I ( as oral iodized oil ) or placebo . We measured urinary iodine ( UI ) , thyroid-stimulating hormone ( TSH ) , and total thyroxine ( TT4 ) concentrations and thyroid gl and volume ( by ultrasound ) . The children were given a battery of 7 cognitive and motor tests , which included measures of information processing , working memory , visual problem solving , visual search , and fine motor skills . Thyroid ultrasound and the biochemical and psychological tests were repeated after 24 wk . RESULTS At baseline , the children 's median UI concentration was 43 microg/L ; 87 % were goitrous , and nearly one-third had low concentrations of circulating TT4 . Treatment with iodine markedly improved iodine and thyroid status : at 24 wk , median UI in the treated group was 172 microg/L , mean TT4 was approximately 40 % higher , and the prevalence of hypothyroxinemia was placebo , iodine treatment significantly improved performance on 4 of 7 tests : rapid target marking , symbol search , rapid object naming , and Raven 's Coloured Progressive Matrices ( P Information processing , fine motor skills , and visual problem solving are improved by iodine repletion in moderately iodine-deficient schoolchildren",
"BACKGROUND Iodine deficiency ( even moderate ) plays a major role in pregnancy associated goiter development , which is only party reversible after pregnancy . The prevalence of post partum thyroiditis is reported to be slightly lower in areas of iodine deficiency . Thus iodine supplementation may be effective in decreasing pregnancy associated increase in thyroid volume , but enhances the risk of increasing the prevalence of thyroid dysfunction in the post partum period . Therefore , we evaluated the effect of iodine supplementation ( with two different doses : 50 microg and 250 microg ) on the prevalence of post partum thyroiditis and the decrease in thyroid volume up to 8 months post partum in an area of mild iodine deficiency . PATIENTS AND METHODS Thyroid volume of 56 women was evaluated 5 days and 3 months after delivery ( study I ) . In an intervention study ( Study II ) 70 women were r and omized to receive 50 or 250 microg of potassium iodide for a period of 8 months post partum beginning five days after delivery . Thyroid volume , the echogenecity of the thyroid gl and , thyroid hormone parameters ( T4 , T3 , fT4 , TSH ) and thyroid antibodies ( TPO and Tg-Ab ) were measured 5 days , 3 and 8 months after delivery . RESULTS A total number of 11 women developed postpartum thyroid dysfunction : 4 women developed manifest thyroid dysfunction ( 3 hyperthyroidism and 1 hypothyroidism ) 3 months post partum . The remaining seven had sub clinical hypo- or hyperthyroidism . All changes were clinical ly mild and transient as evidence d by normalization of thyroid hormone parameters on reexamination at 8 months . Among the eleven , 6 women in the 50 microg iodine group and 5 women of the 250 microg iodine group developed thyroid dysfunction , suggesting that the iodine dose did not affect post partum thyroiditis . The administration of only 50 microg iodine was associated with a significant fall of thyroid size already 3 months after delivery ( 25.4 + /- 1.5 ml ( mean + /- sem ) to 18.2 + /- 1.25 p thyroid volume was observed in women receiving no supplementary iodine ( thyroid volume at delivery 29 + /- 2.2 ml ; at 3 months 27.5 + /- 3.0 ml . CONCLUSION The administration of supplementary iodine ( up to 250 microg ) to an unselected population , residing in an area of mild iodine deficiency , in the post partum period is save as indicated by a prevalence of 5.7 % manifest thyroid dysfunction . These changes are clinical ly mild and transient . Even the amount of 50 microg of iodine supplementation seems to by very efficient in reducing pregnancy associated increments in thyroid volume",
"Serum Tg is widely used in the control of thyroid cancer but also in the diagnosis of certain other thyroid diseases . Serum Tg may be useful in the characterization of the iodine status of a population , but little is known about determinants of serum Tg levels . We examined a r and om selection of 4,649 subjects from 2 regions in Denmark with different iodine status . Thyroid volume and structure were determined with ultrasonography , and thyroid function tests and Tg analysis were performed . The factor with the closest association with serum Tg levels was thyroid volume at ultrasonography ( P thyroid nodularity ( P iodine excretion ( P serum Tg , even after adjusting for the influence of the other parameters . Thyroid dysfunction had a less pronounced but still highly significant association with serum Tg ( P serum TSH in general . The association with age seemed to rely on differences in the prevalence of thyroid abnormalities , and men had lower Tg levels than women of the same age . There was a marked difference in serum Tg between the two regions with slightly different iodine excretion also after adjusting for the other factors . In conclusion , serum Tg reflects thyroid abnormalities and thyroid function and is a sensitive marker of iodine deficiency in a population",
"CONTEXT Thyroglobulin ( Tg ) may be a valuable indicator of improving thyroid function in children after salt iodization . A recently developed Tg assay for use on dried whole blood spots ( DBS ) makes sampling practical , even in remote areas . OBJECTIVE The study aim was to develop a reference st and ard for DBS-Tg , establish an international reference range for DBS-Tg in iodine-sufficient children , and test the st and ardized DBS-Tg assay in an intervention trial . DESIGN , PARTICIPANTS , AND INTERVENTIONS Serum Tg reference material of the European Community Bureau of Reference ( CRM-457 ) was adapted for DBS and its stability tested over 1 yr . DBS-Tg was determined in an international sample of 5- to 14-yr-old children ( n = 700 ) who were euthyroid , anti-Tg antibody negative , and residing in areas of long-term iodine sufficiency . In a 10-month trial in iodine-deficient children , DBS-Tg and other indicators of iodine status were measured before and after introduction of iodized salt . RESULTS Stability of the CRM-457 Tg reference st and ard on DBS over 1 yr of storage at -20 and -50 C was acceptable . In the international sample of children , the third and 97th percentiles of DBS-Tg were 4 and 40 microg/liter , respectively . In the intervention , before introduction of iodized salt , median DBS-Tg was 49 microg/liter , and more than two thirds of children had DBS-Tg values greater than 40 microg/liter . After 5 and 10 months of iodized salt use , median DBS-Tg decreased to 13 and 8 microg/liter , respectively , and only 7 and 3 % of children , respectively , had values greater than 40 microg/liter . DBS-Tg correlated well at baseline and 5 months with urinary iodine and thyroid volume . CONCLUSIONS The availability of reference material and an international reference range facilitates the use of DBS-Tg for monitoring of iodine nutrition in school-age children",
"OBJECTIVE A prospect i ve r and omized trial was performed to assess the usefulness of iodine supplementation in the prevention of goiter in pregnant women living in marginally iodine-deficient areas . DESIGN Eighty-six pregnant women were recruited and r and omized in two groups and treated daily for up to six months after delivery with 200 microg iodide ( group A ) or 50 microg iodide ( group B ) . Sixty-seven women ( 32 in group A and 35 in group B ) completed the study . METHODS Thyroid volume ( TV ) , thyroid functional parameters and urinary iodine concentration were determined in all subjects at booking , at the 18th-26th , and the 29th-33rd week of gestation , and at the 3rd and 6th month after delivery . RESULTS A slight but not significant increase in TV during gestation was observed only in group B. After delivery a progressive decrease in TV was documented in both groups , the final TV being significantly reduced with respect to the initial volume in group A. No significant changes in serum free thyroid hormones and TSH concentrations were found during gestation in either group . Postpartum thyroiditis was observed in 5 women ( 2 in group A , 3 in group B ) . No side effects were seen . CONCLUSION The present data indicate that in marginally iodine-deficient areas , the administration of iodide is recommended in pregnancy and lactation . In the conditions of the present trial a dose of 50 microg iodide/day is a safe and effective measure in preventing an increase in TV during pregnancy but a dose of 200 microg iodide/day appeared to be more effective without inducing side effects and without enhancing the frequency of post-partum thyroiditis",
"In Central Africa , all of northern Zaire is very severely deficient in iodine . A peculiar feature of this endemia is that iodine deficiency and the ensuing thyroid gl and stimulation not only leads to goitre formation but also to progressive thyroid involution and to myxoedematous cretinism . An iodine supplementation trial based on oral administration of small doses of iodine was made in 81 schoolchildren . All of them received a small dose of iodine ( 0.1 ml containing 48 mg ) per os and the thyroid status was followed during 4 months . Blood and urine sample s were collected at the start of the study , then 2 weeks , 2 months and 4 months after iodine administration . Before iodine supplementation the mean urinary iodine level was 0.18 + /- 0.02 micromol/l , and 10 % of the subjects had a urinary iodine level below 0.08 micromol/l . Fifty-two percent of the subjects had a serum thyrotropin ( TSH ) level above 10 mU/l . All the subjects responded to the administration of iodine . and all of them recovered a euthyroid status . Most of them were still euthyroid at the end of the study . However . within 4 or even 2 months , some subjects ( 15 % of the total ) reverted to hypothyroidism . At the entry of the study these subjects were all hypothyroid and had elevated TSH and paradoxically low serum thyroglobulin ( TG ) values . In myxoedematous cretins living in the same area , even lower serum TG levels were found . Together with the absence of goitre , a paradoxically low serum TG Suggests a low thyroid reserve , and in the present case a reduced amount of functional thyroid tissue . We show that the serum TG/TSH ratio may be used as a predictive index of thyroid reserve and of positive response to iodine administration . These data further suggest that thyroid damage is not confined to myxoedematous cretins . but is widely distributed in the phenotypically normal population . Widely distributed thyroid damage may render iodine prophylaxis based on oral administration unpredictable",
"BACKGROUND About one billion people worldwide are at risk for iodine deficiency . Despite existing programs of prophylaxis , the prevention of iodine deficiency is still a challenge throughout the developing world . We studied the efficacy of low doses of iodized oil in an area of severe iodine deficiency in Zaire . METHODS Seventy-five subjects with visible goiter were r and omly assigned to receive a single oral dose of placebo or either 0.1 or 0.25 ml of iodized oil , corresponding to 0 , 47 , and 118 mg of iodine , respectively . The mean ages of the subjects in the three groups were 23 , 22 , and 22 years , respectively , and the ratios of males to females were 0.25 , 0.32 , and 0.19 . Efficacy was assessed by evaluating goiter size and measuring urinary iodine and serum thyroid hormone concentrations for 12 months . RESULTS Goiter size decreased in most of the subjects who received either dose of iodized oil . Their urinary iodine concentrations were normal for six to nine months and their serum thyroxine and thyrotropin concentrations were nearly all normal throughout the study period . There were no side effects , even in subjects whose serum thyroxine concentrations had initially been low . In the placebo group , neither goiter size nor any of the biochemical values changed . CONCLUSIONS The oral administration of a single small dose of iodized oil is capable of correcting iodine deficiency for about a year . This method of supplementation is likely to be more effective , efficient , and acceptable than the administration of either intramuscular or large oral doses of iodized oil",
"During pregnancy complex changes of maternal thyroid function occur and they are influenced by the maternal iodine supply . It has been demonstrated that with decreasing iodine supply maternal goiter and hypothyroxinemia as well as fetal and neonatal hypothyroidism become more prevalent . Therefore iodine supplementation during pregnancy is now strongly recommended also in areas of moderate iodine deficiency . To monitor the success of iodine supplementation and its theoretical risk of increasing the frequency of thyroid autoantibodies , we have investigated the thyroid volume , thyroid function , urinary iodine excretion and antibodies to thyroid peroxidase at 10 - 12 weeks of gestation and postpartum in 38 mothers receiving 300 micrograms potassium iodide/day and in 70 mothers without iodine supplementation . In all of their newborns thyroid volume was determined by ultrasound . The thyrotropin ( TSH ) levels and antibodies to thyroid peroxidase ( TPO-ab ) in the neonates were measured in dried blood spots on filter paper from their newborn screening . Urinary iodine excretion was increased significantly after iodine supplementation in mothers ( p hypo- or hyperthyroidism was observed in the mothers or newborns . Interestingly , no difference of maternal thyroid volumes was observed between the two groups after pregnancy , but the volumes of the thyroid gl and s in newborns of mothers who received iodine were significantly ( p frequency of TPO-ab in either group after pregnancy . In four mothers transplacental passage of these antibodies was documented by positive measurement in the blood sample of the newborn . This study documents that iodine supplementation during pregnancy in an area of moderate iodine deficiency results in a lower size of neonatal thyroid volume and that this supplementation was not accompanied by an increase in the frequency of TPO-ab",
"A controlled trial of iodine supplementation comparing oral with intramuscular iodized oil has been carried out in an iodine deficient area of Zaire . Two years after the administration of 2 ml of oral iodized oil to the population of four villages the overall goitre prevalence had fallen from 64 to 54 % . In a further two villages given 2 ml of intramuscular oil the prevalence fell from 65 to 50 % . The effectiveness of supplementation was also assessed by measuring changes in thyroid function in women of reproductive age . Among women in the villages given oral iodized oil , the geometric mean thyroxine concentration , measured in dried bloodspots , rose from 27.2 to 52.6 nmol/L at the two-year follow-up . This was similar to the response of the intramuscularly treated villages in which thyroxine levels rose from 32.1 to 65.4 nmol/L. There was no change in goitre prevalence or thyroid function in two control villages . Oral iodized oil is a cheaper and simpler alternative to the injected form providing effective iodine prophylaxis for up to two years after a single dose",
"BACKGROUND Low levels of circulating thyroid hormones have been associated with poorer general and neurodevelopmental outcome in preterm babies and it has been speculated that the association is causal . Low levels of circulating thyroid hormone have been reported after inadequate intake of iodine in preterm infants being fed milk formula . AIM To investigate whether increased iodine intake from supplemented preterm formula would improve thyroid hormone levels in preterm babies ( this study ) and hence improve neurodevelopmental status ( planned subsequent study ) . METHOD A total of 121 preterm infants were entered into a r and omised controlled trial of st and ard ( 68 μg/l ) versus increased ( 272 μg/l ) iodine in preterm formula . RESULTS The two groups were comparable at recruitment . No evidence of an effect of the intervention on thyroid hormone levels was seen up to 41 weeks after conception . CONCLUSION Calls for increased iodine content of preterm infant formulas are not justified by this study . Key message Increasing milk iodine content in line with the latest recommendations for preterm babies had no effect on thyroid hormone levels in the perinatal",
"The effect of oral iodine supplementation on total goitre rate ( % TGR ) and urinary iodine excretion among school children 4 to 16 years of age was studied . In the first group ( n = 57 ) 200 mg oral iodized oil reduced % TGR from 31.6 % to 17.5 % and 33.3 % to 24.6 % in males and females respectively , while in the second group ( n = 53 ) , 400 mg iodine reduced the % TGR from 34.0 % to 20.8 % in males and 35.9 % to 24.5 % in females after 13 months of intervention . This gave a relative indication that the 200 mg is as effective as the 400 mg in goitre reduction . In subsequent tests , the maximum urinary iodine excretion was obtained from the groups which received two doses of iodized oil 24 hours after the intervention . A significant ( p = 0.003 ) greater increase in urinary iodine excretion was noted at 24 hours among both male and female children administered 400 mg than among those who received 200 mg . Measurements after 24 hours showed no significant difference between urinary iodine excretion of the two dose groups . These results suggest that : ( i ) 200 mg is likely equally effective as 400 mg for iodine deficiency disorders control and prevention among children and ( ii ) iodine could be administered annually rather than biannually"
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The number of people with diabetes and pre-diabetes are exponentially increasing . Studies on humans have shown the beneficial effects of Zinc supplementation in patients with diabetes . The present study aims to systematic ally evaluate the literature and meta-analyze the effects of Zinc supplementation on diabetes . A systematic review of published studies reporting the effects of Zinc supplementations on diabetes mellitus was undertaken . The literature search was conducted in the following data bases ; PubMed , Web of Science and SciVerse Scopus . A meta- analysis of studies examining the effects of Zinc supplementation on clinical and biochemical parameters in patients with diabetes was performed . The total number of articles included in the present review is 25 , which included 3 studies on type-1 diabetes and 22 studies on type-2 diabetes . There were 12 studies comparing the effects of Zinc supplementation on fasting blood glucose in patients with type-2 diabetes . The pooled mean difference in fasting blood glucose between Zinc supplemented and placebo groups was 18.13mg/dl ( 95%CI:33.85,2.41 ; p 2-h post-pr and ial blood sugar also shows a similar distinct reduction in ( 34.87mg/dl [ 95%CI:75.44 ; 5.69 ] ) the Zinc treated group . The reduction in HbA1c was 0.54 % ( 95%CI:0.86;0.21 ) in the Zinc treated group . There were 8 studies comparing the effects of Zinc supplementation on lipid parameters in patients with type-2 diabetes . The pooled mean difference for total cholesterol between Zinc supplemented and placebo groups was 32.37mg/dl ( 95%CI:57.39,7.35 ; p . Low-density lipoprotein cholesterol also showed a similar distinct reduction in the Zinc treated group , the pooled mean difference from r and om effects analysis was 11.19mg/dl ( 95%CI:21.14,1.25 ; p reduction in systolic and diastolic blood pressures after Zinc supplementation . This first comprehensive systematic review and meta- analysis on the effects of Zinc supplementation in patients with diabetes demonstrates that Zinc supplementation has beneficial effects on glycaemic control and promotes healthy lipid parameters . Further studies are required to identify the exact biological mechanisms responsible for these results
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"Aims : To evaluate the effects of zinc with or without other antioxidants on blood glucose , lipid profile , and serum creatinine in adult diabetics on long-term follow-up . Material s and methods : Patients ( n = 96 ) were r and omly allocated to three groups : group A ( n = 29 ) was supplemented with oral zinc sulfate ( 22 mg/day ) and multivitamin/mineral ( zinc+MVM ) preparation ; group B ( n = 31 ) was given the same preparation without zinc ( MVM ) ; and group C ( n = 36 ) was given a matching placebo for a period of 4 months in a single-blinded study . Blood sample s were taken at baseline and after 4 months of supplementation to assess blood glucose ( fasting and postpr and ial ) and glycosylated hemoglobin ( HbA1C% ) and serum levels of zinc , creatinine , and lipids . Results : The zinc+MVM group had a mean change of fasting blood sugar −0.33 mmol/L ( st and ard error of the mean 0.21 mmol/L ) and was significant ( P = 0.05 ) when compared with the other two groups ( mean change in the MVM group + 0.19 ( 0.31 ) mmol/L and + 0.43 ( 0.23 ) mmol/L in the control group , respectively ) . The HbA1C% level reduced significantly , irrespective of the baseline level , in zinc+MVM-supplemented individuals . In the other two groups , the change of HbA1C% level was not significant . Serum lipid levels reduced significantly in the zinc+MVM and MVM groups . Conclusions : Zinc+MVM supplementation showed beneficial effects in the metabolic control of adult diabetics in addition to elevating their serum zinc level . Zinc supplementation improved glycemic control measured by HbA1C% and fasting and postpr and ial glucose . Furthermore , zinc supplementation lowered serum cholesterol and cholesterol/high-density lipoprotein ratio ",
"Objective : To determine the effects of combined zinc ( Zn ) and chromium ( Cr ) supplementation on oxidative stress and glucose homeostasis of people with type 2 diabetes . Design : Tunisian adult subjects with HbA1C > 7.5 % were supplemented for 6 months with 30 mg/d of Zn as Zn gluconate or 400 μg/d of Cr as Cr pidolate or combined Zn/Cr supplementation or placebo . The effects of supplementation on plasma zinc ( Zn ) , copper ( Cu ) , selenium ( Se ) , urinary Zn , Cr , plasma thiobarbituric acid reactive substances ( TBARS ) , Cu-Zn superoxide dismutase ( SOD ) and Se glutathione peroxidase ( GPx ) in red blood cells , blood lipids and lipoproteins , HbA1C and fasting glucose were measured at the beginning of the study and after six months . Results : At the beginning of the study , more than 30 % of the subjects may have been Zn deficient with plasma Zn values less than 10.7 μmol/L , whereas levels of plasma Cu , Se and antioxidant RBC enzyme activities were in the normal ranges . Following supplementation , there were significant decreases of plasma TBARS in the Cr ( 13.6 % ) , Zn ( 13.6 % ) and Zn/Cr ( 18.2 % ) groups with no significant changes in the placebo group . The value for the TBARS of the control healthy Tunisian subjects was 2.08 ± 0.04 μmol/L and that of the Tunisian subjects with diabetes was 3.32 ± 0.05 μmol/L. This difference of 1.24 μmol/L between the control group and the subjects with diabetes was reduced from 36 % to 50 % in the three supplemented groups . Supplementation did not modify significantly HbA1C nor glucose homeostasis . No adverse effects of Zn supplementation were observed on Cu status , HDL cholesterol nor interactions in Zn or Cr . Conclusions : These data suggest the potential beneficial antioxidant effects of the individual and combined supplementation of Zn and Cr in people with type 2 DM . These results are particularly important in light of the deleterious consequences of oxidative stress in people with diabetes",
"Non-insulin-dependent diabetes mellitus ( NIDDM ) may cause vulnerability to moderate zinc deficiency . In this study , short-term zinc supplementation ( 30 mg/d as amino acid chelate for 3 wk ) elevated plasma zinc and activities of 5'-nucleotidase , a zinc-dependant enzyme , in 20 postmenopausal women with NIDDM . Placebo , given to 20 other women with NIDDM , had no effects on these indexes nor on any others taken in this study . Although zinc supplementation doubled the mean value for 5'-nucleotidase activity , values were still significantly lower than those of age-matched control subjects . Plasma insulin-like growth factor I concentrations increased with zinc treatment if starting concentrations were 165 microg/L. Lipoprotein oxidation in vitro , which has abnormal lag times and propagation rates for subjects with NIDDM and for moderately zinc-deficient rats , were unchanged by zinc supplementation . Possibly , this lack of effect occurred because the zinc treatment did not normalize zinc status . In conclusion , this study supports the contention that moderate zinc deficiency occurs frequently in subjects with NIDDM",
"DESIGN Placebo for 3 months , followed by 30 mg/day zinc gluconate in identical capsules . SETTING Diabetic out patients clinic at the University Hospital , Grenoble . SUBJECTS Diabetic patients cared for type I diabetes mellitus . 22 patients began the study , 4 dropped out . 10 patients suffered of an early retinopathy , 8 patients had no retinopathy . INTERVENTIONS In this order : T0 biological measurements , 3 months placebo treatment , T1 biological measurements , 3 months zinc gluconate treatment , T2 biological measurements . Plasma Zn , Cu , Se , thiobarbituric acid reactants and antioxidant enzymes were measured [ plasma and red glutathione peroxidase ( Se-GPx ) , red cell superoxide dismutase ( Cu-Zn-SOD ) ] . RESULTS Lower plasma zinc level in the two groups . An increase in zinc level was observed and was more important in diabetic patients with no retinopathy ( P = 0.05 ) . The thiobarbituric acid reactants were above the reference values in all the patients , and were decreased at T2 ( P of GPx activity after zinc supplementation in patients with retinopathy . CONCLUSIONS Zinc deficiency in insulin-dependent diabetic patients is corrected by a zinc supplementation . Moreover this supplementation decreases lipid peroxidation . The effects of zinc are different in diabetic patients with or without retinopathy . The increase in Se-GPx activity observed in patients with retinopathy could be linked to the protective effect of zinc on the protein itself",
"Objective : The present study design ed to assess the effect of Mg+Zn , vitamin C+E , and combination of these micronutrients on blood pressure in type 2 diabetic patients . Material s and Methods : In a r and omized , double-blind , placebo controlled clinical trial , 69 type 2 diabetic patients were r and omly divided into four groups , each group receiving one of the following daily supplement for three months ; group M : 200 mg Mg and 30 mg Zn ( n = 16 ) , group V : 200 mg vitamin C and 150 mg vitamin E ( n = 18 ) , group MV : minerals plus vitamins ( n = 17 ) , group P : placebo ( n = 18 ) . Blood pressure was measured at the beginning and at the end of the trial . Treatment effects were analyzed by general linear modeling . Results : Results indicate that after three months of supplementation levels of systolic , diastolic and mean blood pressure decreased significantly in the MV group by 8 mmHg ( 122 ± 16 vs. 130 ± 19 mmHg ) , 6 mmHg ( 77 ± 9 vs. 83 ± 11 mmHg ) , and 7 mmHg ( 92 ± 9 vs. 99 ± 13 mmHg ) , respectively ( p combination of vitamin and mineral supplementation had significantly effects in increasing serum potassium ( p decreasing serum malondialdehyde ( p type 2 diabetic patients a combination of vitamins and minerals , rather than vitamin C and E or Mg and Zn , might decrease blood pressure ",
"Glycemic control and prevention of secondary complications are the most important goals of using pharmacologic treatment of diabetes mellitus ( DM ) . The inadequate responses to oral hypoglycemic agents may be attributed to inadequate postreceptor events even when insulin levels are quite sufficient , and associated with oxidative stress induced by long-term hyperglycemia . The administration of antioxidants such as melatonin and zinc may improve tissue responses to insulin and increase the efficacy of drugs , e.g. metformin , which act through this pathway . This project was design ed to evaluate the effects of melatonin and zinc on the lipid profile and renal function in type 2 DM patients poorly controlled with metformin . A placebo-controlled , double-blind clinical trial was performed in which 46 type 2 diabetic patients were selected and allocated into three groups . These groups were treated with single daily oral doses of both 10 mg of melatonin and 50 mg of zinc acetate alone : 10 mg of melatonin and 50 mg of zinc acetate in addition to the regularly used metformin or placebo , given at bedtime for 90 days . Fasting lipid profiles and microalbuminuria ( MAU ) were measured before initiating the treatments ( zero time ) and after 30 and 90 days of treatment . Daily administration of melatonin and zinc improved the impaired lipid profile and decreased the level of MAU ; the addition of this treatment regimen in combination with metformin improved the tissue responses to this oral hypoglycemic agent . In conclusion , the combination of melatonin and zinc acetate , when used alone or in combination with metformin , improves DM-related complications such as the impaired lipid profile and MAU in type 2 DM patients",
"Background and aim There is accumulating evidence that shows the metabolism of zinc and vitamin A are altered in diabetes mellitus type I ( DMTI ) , thus the present study was conducted to evaluate the effects of combination of zinc and vitamin A supplementation on serum fasting blood sugar ( FBS ) , insulin , apoprotein B and apoprotein A-I in patients with DMTI . Design Forty-eight , 7-year-old to 20-year-old patients with at least 2 years of DMTI history , without any metabolic condition or medicine intake with insulin treatment , participated in a r and omized double-blind clinical trial for 12 weeks . They were divided into zinc and vitamin A (VAZ)-supplemented ( 10 mg elemental zinc per day and one-half of a 25,000 IU vitamin A tablet every other day ) and /or placebo groups after matching for sex , age and DMTI duration . Nutrient intake was estimated using 24 h recall and was analyzed by food processor program . Serum apoproteins B and A-I , FBS and insulin levels were determined at the beginning and end of the trial . Results There was significant increase in apoprotein A-I ( P decrease in apoprotein B ( P apoprotein B/apoprotein A-I ratio ( P apoprotein A-I had a significant increase ( P apoprotein B/apoprotein A-I ratio had a significant decrease ( P = 0.02 ) at the end of study in the VAZ group compared with the control group Conclusion It seems that combined zinc and vitamin A supplementation can improve serum apoprotein A-I , apoprotein B and the apoprotein B/apoprotein A-I ratio in patients with DMTI",
"OBJECTIVE The present study was design ed to assess the effect of magnesium plus zinc , vitamins C plus E , and a combination of these micronutrients on nephropathy indexes in type 2 diabetic patients . RESEARCH DESIGN AND METHODS In a r and omized , double-blind , placebo-controlled clinical trial , 69 type 2 diabetic patients were r and omly divided into four groups , each group receiving one of the following daily supplement for 3 months : group M ( n = 16 ) , 200 mg Mg and 30 mg Zn ; group V ( n = 18 ) , 200 mg vitamin C and 100 IU vitamin E ; group MV ( n = 17 ) , minerals plus vitamins ; and group P ( n = 18 ) , placebo . Urinary albumin excretion and N-acetyl-beta-d-glucosaminidase activity ( NAG ) in urine were determined at the beginning and at the end of the trial . Treatment effects were analyzed by general linear modeling . RESULTS Results indicate that after 3 months of supplementation , levels of urinary albumin excretion decreased in the V and MV groups ( P = 0.034 and P = 0.005 , respectively ) . Urinary NAG activity did not significantly change in any treatment groups . Levels of systolic , diastolic , and mean blood pressure significantly decreased in the MV group ( P = 0.008 , P = 0.017 , and P = 0.009 , respectively ) . Also , combination of vitamin and mineral supplementation had significant effects in decreasing fasting serum glucose ( P = 0.035 ) and malondialdehyde concentrations ( P = 0.004 ) and in increasing HDL cholesterol and apolipoprotein A1 levels ( P = 0.019 ) . There was no significant change in the levels of these parameters in the other three groups . CONCLUSIONS In conclusion , the results of the present study provide evidence for the effects of vitamins C and E and also combination of magnesium , zinc , and vitamins C and E supplementation on improvement of glomerular but not tubular renal function in type 2 diabetic patients",
"OBJECTIVE This study evaluated the effects of exenatide , a novel incretin mimetic , in hyperglycemic patients with type 2 diabetes unable to achieve glycemic control with metformin-sulfonylurea combination therapy . RESEARCH DESIGN AND METHODS A 30-week , double-blind , placebo-controlled study was performed in 733 subjects ( aged 55 + /- 10 years , BMI 33.6 + /- 5.7 kg/m(2 ) , A1C 8.5 + /- 1.0 % ; means + /- SD ) r and omized to 5 microg subcutaneous exenatide b.i.d . ( arms A and B ) or placebo for 4 weeks . Thereafter , arm A remained at 5 microg b.i.d . and arm B escalated to 10 microg b.i.d . Subjects continued taking their dose of metformin and were r and omized to either maximally effective ( MAX ) or minimum recommended ( MIN ) doses of sulfonylurea . RESULTS Week 30 A1C changes from baseline ( + /-SE ) were -0.8 + /- 0.1 % ( 10 microg ) , -0.6 + /- 0.1 % ( 5 microg ) , and + 0.2 + /- 0.1 % ( placebo ; adjusted P exenatide-treated subjects were more likely to achieve A1C or = 7 % than placebo-treated subjects ( 34 % [ 10 microg ] , 27 % [ 5 microg ] , and 9 % [ placebo ] ; P weight loss ( -1.6 + /- 0.2 kg from baseline each exenatide arm , -0.9 + /- 0.2 kg placebo ; P Mild or moderate nausea was the most frequent adverse event . The incidence of mild/moderate hypoglycemia was 28 % ( 10 microg ) , 19 % ( 5 microg ) , and 13 % ( placebo ) and appeared lower with MIN than with MAX sulfonylurea treatment . CONCLUSIONS Exenatide significantly reduced A1C in patients with type 2 diabetes unable to achieve adequate glycemic control with maximally effective doses of combined metformin-sulfonylurea therapy . This improvement in glycemic control was associated with no weight gain and was generally well tolerated",
"Purpose This study was design ed to evaluate the effect of antioxidant supplementation on diabetic retinopathy ( DR ) over a 5-year follow-up period . To our knowledge , this is the first such clinical trial performed . Methods We recruited 105 type 2 diabetic patients with nonproliferative DR . A complete ophthalmic checkup and a plasma determination of oxidative ( malonyldialdehyde [ MDA ] ) and antioxidant parameters ( total antioxidant status [ TAS ] ) were obtained as the baseline . One part of the cohort was r and omly assigned to oral antioxidant supplementation at nutritional doses . The same examinations were performed with 97 diabetic patients who completed the 5-year follow-up period . The best-corrected visual acuity , DR score , MDA , and TAS values were compared at the beginning and the end of the follow-up . Results Best-corrected visual acuity did not change during the follow-up , irrespective of supplementation . However , the retinopathy stage showed a retardation of progression in the subgroup with supplementation , but worsened in the subgroup with no antioxidant supplementation . Furthermore , the antioxidant supplementation group maintained its antioxidant plasma status levels , which was related to decreased oxidative plasma activity . Conclusions Oral antioxidant supplementation could be a useful adjunctive long-term therapy in the treatment of nonproliferative DR",
"CONTEXT Controversy and uncertainty ensue when the results of clinical research on the effectiveness of interventions are subsequently contradicted . Controversies are most prominent when high-impact research is involved . OBJECTIVES To underst and how frequently highly cited studies are contradicted or find effects that are stronger than in other similar studies and to discern whether specific characteristics are associated with such refutation over time . DESIGN All original clinical research studies published in 3 major general clinical journals or high-impact-factor specialty journals in 1990 - 2003 and cited more than 1000 times in the literature were examined . MAIN OUTCOME MEASURE The results of highly cited articles were compared against subsequent studies of comparable or larger sample size and similar or better controlled design s. The same analysis was also performed comparatively for matched studies that were not so highly cited . RESULTS Of 49 highly cited original clinical research studies , 45 cl aim ed that the intervention was effective . Of these , 7 ( 16 % ) were contradicted by subsequent studies , 7 others ( 16 % ) had found effects that were stronger than those of subsequent studies , 20 ( 44 % ) were replicated , and 11 ( 24 % ) remained largely unchallenged . Five of 6 highly-cited nonr and omized studies had been contradicted or had found stronger effects vs 9 of 39 r and omized controlled trials ( P = .008 ) . Among r and omized trials , studies with contradicted or stronger effects were smaller ( P = .009 ) than replicated or unchallenged studies although there was no statistically significant difference in their early or overall citation impact . Matched control studies did not have a significantly different share of refuted results than highly cited studies , but they included more studies with \" negative \" results . CONCLUSIONS Contradiction and initially stronger effects are not unusual in highly cited research of clinical interventions and their outcomes . The extent to which high citations may provoke contradictions and vice versa needs more study . Controversies are most common with highly cited nonr and omized studies , but even the most highly cited r and omized trials may be challenged and refuted over time , especially small ones",
"Oxidative stress is known to be an important contributing factor in many chronic diseases . We tested the hypothesis that in healthy normal volunteers zinc acts as an effective anti-inflammatory and antioxidant agent . Ten normal volunteers were administered daily oral zinc supplementation ( 45 mg zinc as gluconate ) and 10 volunteers received placebo for 8 weeks . Plasma zinc , MDA , HAE , and 8-OHdG levels ; LPS-induced TNF-alpha and IL-1beta mRNA ; and ex vivo TNF-alpha-induced NF-kappaB activity in mononuclear cells ( MNC ) were determined before and after supplementation . In subjects receiving zinc , plasma levels of lipid peroxidation products and DNA adducts were decreased , whereas no change was observed in the placebo group . LPS-stimulated MNC isolated from zinc-supplemented subjects showed reduced mRNA for TNF-alpha and IL-1beta compared to placebo . Ex vivo , zinc protected MNC from TNF-alpha-induced NF-kappaB activation . In parallel studies using HL-60 , a promyelocytic cell line , we observed that zinc enhances the upregulation of mRNA and DNA-specific binding for A20 , a transactivating factor which inhibits the activation of NF-kappaB. Our results suggest that zinc supplementation may lead to downregulation of the inflammatory cytokines through upregulation of the negative feedback loop A20 to inhibit induced NF-kappaB activation . Zinc administration to human subjects with conditions associated with increased oxidative stress should be explored",
"Objective : To determine the effects of zinc ( Zn ) supplementation on oxidative stress in persons with type 2 diabetes mellitus ( type 2 DM ) . Design : Tunisian adult subjects with HbA1c > 7.5 % were supplemented for six months with 30 mg/day of Zn as Zn gluconate or placebo . The effects of supplementation on plasma zinc ( Zn ) , copper ( Cu ) , urinary Zn , plasma thiobarbituric acid reactive substances ( TBARS ) , Cu-Zn superoxide dismutase ( SOD ) and glutathione peroxidase activities ( GPX ) in red blood cells , blood lipids and lipoproteins , HbA1c and fasting glucose were measured at the beginning of the study and after three and six months . Results : At the beginning of the study , more than 30 % of the subjects exhibited plasma Zn values less than the normal minimum of 10.7 μmol/L , whereas levels of plasma Cu and antioxidant RBC Cu-Zn SOD and GPx enzyme activities were in the normal ranges . Oxidative stress , monitored by plasma TBARS , was increased in individuals with diabetes compared with healthy Tunisian subjects ( 3.32 ± 0.05 μmol/L vs. 2.08 ± 0.04 μmol/L ) and an inverse correlation was found between Zn plasma levels and plasma TBARS . After three and six months of Zn supplementation , all of the subjects exhibited plasma Zn values greater than 10.7 μmol/L. There was a decrease of plasma TBARS in Zn supplemented group after six months ( 15 % ) with no significant changes in the placebo group . Supplementation did not alter significantly HbA1c nor glucose homeostasis . No adverse effects of Zn supplementation were observed on Cu status or HDL cholesterol . Conclusions : These data suggest the potential beneficial antioxidant effects of Zn supplementation in persons with type 2 DM . These results are particularly important in light of the deleterious consequences of oxidative stress in persons with diabetes",
"OBJECTIVE The present study is an attempt to assess serum zinc level in a sample of diabetic patients ( both type 1 and type 2 diabetics ) in comparison with those of apparently healthy controls , and to ascertain the relationship between the levels of serum zinc with some epidemiological variables . Furthermore , a trial of zinc supplementation for 3 months conducted to assess the effect of zinc supplementation on glycemic control of the studied type 2 diabetic patients , and the factors that affect the response to this supplementation . METHODS Collection of data was carried out during the period between November 2002 to February 2003 at the Diabetic Center of Merjan Teaching Hospital in Babil Governorate , Iraq . In the first part of the study ( a case-control study ) , the diabetic group included 133 diabetic patients ( type 1 and 2 ) who were chosen from patients attending the Diabetic Center during the period of the study . The control group included 133 apparently healthy subjects who were selected from the workers of the same hospital . Selection of cases and controls was carried out by using systematic r and om sampling procedure . In the second part of the study ( single blind were intervention study ) , type 2 diabetic patients ( 101 patients ) divided into 2 groups ; the first group included 50 patients supplemented with oral zinc sulfate ( 30 mg of elemental zinc/cap/day ) for 3 months and second group included 51 patients given placebo and design ed as control group . RESULTS The first part of the study shows that the mean value for serum zinc level was significantly lower in diabetic patients than healthy controls ( 64.2 + /- 12.6 microg/dl for type 1 diabetics , and 68.9 + /- 11.9 microg/dl for type 2 diabetics versus 83.4 + /- 12.5 microg/dl for healthy controls ) . Using simple linear regression , significant positive correlation was found between serum zinc level and years of education and significant negative correlation was found between serum zinc level and baseline HbA1c% value , in the diabetic group . While significant positive correlation found between serum zinc level and estimated zinc intake in the control group . Using multiple regression analysis , serum zinc level showed significant positive correlation with gender ( being a male compared with female ) , and estimated zinc intake and significant negative correlation with diabetes state ( diabetic compared with non-diabetic ) , residence ( urban compared with rural residents ) , and plant protein intake . The second part of the study shows that the mean value for HbA1c% concentration of the supplemented group decreased significantly at the end of the 3 months of follow up , while no significant changes were found in the mean value for HbA1c% of the control group . The present study showed that the change in HbA1c% after supplementation had significant negative correlation with baseline HbA1c% value . CONCLUSION Diabetic patients have significantly lower mean serum zinc levels compared with healthy controls . Zinc supplementation for type-2 diabetics has beneficial effects in elevating their serum zinc level , and in improving their glycemic control that is shown by decreasing their HbA1c% concentration",
"OBJECTIVE The purpose of the present study was to assess the impact of Mg + Zn , Vitamins C + E , and combination of these micronutrients on serum lipid and lipoprotein profiles in type 2 diabetic patients . MATERIAL S AND METHODS In a r and omized , double-blind , placebo controlled clinical trial , 69 type 2 diabetic patients were r and omly divided into four groups , each group receiving one of the following daily supplement for 3 months ; group M : 200 mg Mg and 30 mg Zn ( n = 16 ) , group V : 200 mg Vitamin C and 150 mg Vitamin E ( n = 18 ) , group MV : minerals plus vitamins ( n = 17 ) , group P : placebo ( n = 18 ) . Fasting blood and urine sample s were collected at the beginning and at the end of the trial . Serum triglyceride , total cholesterol , high density lipoprotein cholesterol ( HDL-c ) and low density lipoprotein cholesterol ( LDL-c ) were measured enzymatically . Apolipoproteins ( apo ) A1 and B were measured by immunoturbidimetric method . Adjustment for differences in baselines covariates and changes in variables during study were performed by analysis of covariance using general linear models . RESULTS Results indicate that after 3 months of supplementation mean serum levels of HDL-c and apo A1 increased significantly in the MV group by 24 % ( 50.4 + /-19.3 mg/dl versus 40.6 + /- 10.8 mg/dl ) and 8.8 % ( 169.8 + /- 33.8 mg/dl versus 156.1 + /- 23.9 mg/dl ) , respectively ( P Serum levels of total cholesterol , LDL-c , triglyceride , and apo B were not altered after supplementation in all four groups . CONCLUSION It is concluded that since co-supplementation of Mg , Zn , Vitamins C and E significantly increases HDL-c and apo A1 , supplementation of these micronutrients could be recommended for the type 2 diabetic patients based on their daily requirements",
"AIM The aim of the present study was to determine if micronutrients supplementation can improve neuropathy indices in type 2 diabetes . MATERIAL S AND METHODS In this r and omized , double-blind , placebo-controlled clinical trial , 75 type 2 diabetes patients were assigned to three treatment groups , receiving one of the following daily supplement for 4 months : Group MV : zinc ( 20 mg ) , magnesium ( 250 mg ) , vitamin C ( 200 mg ) and E ( 100 mg ) ; Group MVB : both of the above mineral and vitamin supplements plus vitamin B1 ( 10 mg ) , B2 ( 10 mg ) , B6 ( 10 mg ) , biotin ( 200 μg ) , B12 ( 10 μg ) and folic acid ( 1 mg ) ; Group P : placebo . RESULTS 67 patients completed the study . Neuropathic symptoms based on the MNSI question naire improved from 3.45 to 0.64 ( p=0.001 ) in group MVB , from 3.96 to 1.0 ( p=0.001 ) in group MV and from 2.54 to 1.95 in placebo group after 4 months . There was no significant difference between three treatment groups in MNSI examinations after 4 months supplementations . Over 4 months of treatment , patients showed no significant changes in glycemic control , capillary blood flow or electrophysiological measures in MV and MVB groups compared with placebo group . CONCLUSIONS These studies suggest that micronutrients supplementation might ameliorate diabetic neuropathy symptoms",
"OBJECTIVES Oxidative stress can contribute to microvascular complications in diabetes . A decisive event associated with this condition may be the decrease in the synthesis of zinc-containing antioxidant enzymes such as superoxide dismutase and glutathione peroxidase . This consideration led us to investigate the effect of zinc supplementation versus placebo on microalbuminuria in diabetic patients in a r and omized double blind clinical trial . METHODS Fifty diabetic patients with microalbuminuria were enrolled . Fasting plasma glucose , HbA1c , lipid profiles , plasma zinc levels and r and om urine for albumin and creatinine were measured . Patients r and omly received 30 mg elemental zinc ( group 1 ) or placebo ( group 2 ) for 3 months . After a 4 week wash-out period , the groups were crossed over ( i.e. the zinc group were given placebo , and the placebo group were given zinc ) and the protocol was repeated . RESULTS From an initial number of 50 selected patients ( 25 in each of two groups ) , 39 patients ( 21 in group 1 and 18 in group 2 ) completed the study . In group 1 , after zinc supplementation , urinary albumin excretion decreased significantly from 86.5 + /- 57 to 75 + /- 71 mg/g ( p = 0.01 ) . After placebo , patients in group 1 showed no significant reduction in microalbuminuria ( 85 + /- 72 mg/g to 83 + /- 63 mg/g creatinine ) . In group 2 , no change in albumin excretion was observed after placebo treatment ( 90.5 + /- 63 mg/g to 90 + /- 60 mg/g creatinine ) . After zinc supplementation , a significant reduction was observed in albumin excretion , from 90 + /- 60 mg/g to 85 + /- 57 mg/g creatinine ( p = 0.003 ) . CONCLUSIONS Zinc supplementation reduced albumin excretion in microalbuminuric type 2diabetic patients . This outcome may be due to the antioxidant effect of zinc",
"The present double blind r and omized study was conducted on 50 subjects ; 20 age and sex matched healthy controls ( Group -- I ) ; 15 patients of diabetes mellitus with neuropathy who received placebo for 6 weeks ( Group -- IIA ) ; and 15 patients of diabetes mellitus with neuropathy who were given supplemental zinc sulphate ( 660 mg ) for 6 weeks ( Group -- IIB ) . Serum zinc level , fasting blood sugar ( FBS ) and post pr and ial blood sugar ( PPBS ) levels and motor nerve conduction velocity ( MNCV ) were estimated on day 0 and after 6 weeks in all subjects . Serum zinc levels were significantly low ( p FBS , PPBS and MNCV ( median and common peroneal nerve ) were highly significant ( P = 0.05 ) in group IIA . No improvement ( P = > 0.05 ) in autonomic dysfunction was observed in either groups . Therefore , oral zinc supplementation helps in achieving better glycemic control and improvement in severity of peripheral neuropathy as assessed by MNCV",
"BACKGROUND Observational and experimental data suggest that antioxidant and /or zinc supplements may delay progression of age-related macular degeneration ( AMD ) and vision loss . OBJECTIVE To evaluate the effect of high-dose vitamins C and E , beta carotene , and zinc supplements on AMD progression and visual acuity . DESIGN The Age-Related Eye Disease Study , an 11-center double-masked clinical trial , enrolled participants in an AMD trial if they had extensive small drusen , intermediate drusen , large drusen , non central geographic atrophy , or pigment abnormalities in 1 or both eyes , or advanced AMD or vision loss due to AMD in 1 eye . At least 1 eye had best-corrected visual acuity of 20/32 or better . Participants were r and omly assigned to receive daily oral tablets containing : ( 1 ) antioxidants ( vitamin C , 500 mg ; vitamin E , 400 IU ; and beta carotene , 15 mg ) ; ( 2 ) zinc , 80 mg , as zinc oxide and copper , 2 mg , as cupric oxide ; ( 3 ) antioxidants plus zinc ; or ( 4 ) placebo . MAIN OUTCOME MEASURES ( 1 ) Photographic assessment of progression to or treatment for advanced AMD and ( 2 ) at least moderate visual acuity loss from baseline ( > or = 15 letters ) . Primary analyses used repeated- measures logistic regression with a significance level of.01 , unadjusted for covariates . Serum level measurements , medical histories , and mortality rates were used for safety monitoring . RESULTS Average follow-up of the 3640 enrolled study participants , aged 55 - 80 years , was 6.3 years , with 2.4 % lost to follow-up . Comparison with placebo demonstrated a statistically significant odds reduction for the development of advanced AMD with antioxidants plus zinc ( odds ratio [ OR ] , 0.72 ; 99 % confidence interval [ CI ] , 0.52 - 0.98 ) . The ORs for zinc alone and antioxidants alone are 0.75 ( 99 % CI , 0.55 - 1.03 ) and 0.80 ( 99 % CI , 0.59 - 1.09 ) , respectively . Participants with extensive small drusen , nonextensive intermediate size drusen , or pigment abnormalities had only a 1.3 % 5-year probability of progression to advanced AMD . Odds reduction estimates increased when these 1063 participants were excluded ( antioxidants plus zinc : OR , 0.66 ; 99 % CI , 0.47 - 0.91 ; zinc : OR , 0.71 ; 99 % CI , 0.52 - 0.99 ; antioxidants : OR , 0.76 ; 99 % CI , 0.55 - 1.05 ) . Both zinc and antioxidants plus zinc significantly reduced the odds of developing advanced AMD in this higher-risk group . The only statistically significant reduction in rates of at least moderate visual acuity loss occurred in persons assigned to receive antioxidants plus zinc ( OR , 0.73 ; 99 % CI , 0.54 - 0.99 ) . No statistically significant serious adverse effect was associated with any of the formulations . CONCLUSIONS Persons older than 55 years should have dilated eye examinations to determine their risk of developing advanced AMD . Those with extensive intermediate size drusen , at least 1 large druse , non central geographic atrophy in 1 or both eyes , or advanced AMD or vision loss due to AMD in 1 eye , and without contraindications such as smoking , should consider taking a supplement of antioxidants plus zinc such as that used in this study",
"OBJECTIVES Elevated homocysteine levels are considered to be an independent risk factor for cardiovascular complications in diabetic patients . The aim of this study was to find out if zinc supplementation improves homocysteine levels , which may exert vascular-protective effects in type 2 diabetes subjects with microalbuminuria . METHODS In a r and omized , double-blind , controlled , crossover study , 50 type 2 diabetic patients with microalbuminuria were subdivided into two groups and supplemented with 30 mg/d of zinc ( group 1 ) or placebo ( group 2 ) for three months with a four-week wash out period . Serum creatinine , vitamin B(12 ) , folate , fasting plasma glucose , HbA1c , lipid profiles , zinc , homocysteine levels and r and om urine albumin were measured before and after the first and second phase of the study in all participants . RESULTS Mean serum zinc was significantly increased after zinc supplementation ( from 76 + /- 16 mug/dl to 93 + /- 20 microg/dl ; p zinc supplementation , homocysteine levels reduced significantly ( from 13.71 + /- 3.84 mumol/l to 11.79 + /- 3.06 mumol/l ; p urine albumin excretion and serum homocysteine ( r = 0.37 , p = 0.023 ) . Vitamin B(12 ) and folate levels increased significantly in patients who received zinc in comparison to those who received placebo . A negative correlation was observed between homocysteine and vitamin B(12 ) concentration ( r = -0.36 , p = 0.025 ) . CONCLUSION Zinc supplementation reduced serum homocysteine and increased vitamin B(12 ) and folate concentrations in type 2 diabetic patients with microalbuminuria"
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Purpose Two design concepts are currently used for unicondylar knee arthroplasty ( UKA ) prostheses : fixed bearing ( FB ) and mobile bearing ( MB ) . While MB prostheses have theoretical advantages over their FB counterparts , it is not clear whether they are associated with better outcomes . A systematic review was conducted to examine survivorship differences and differences in failure modes of between FB and MB design s. Methods PubMed , Scirus and Cochrane library data bases were search ed for medial UKA outcome studies . A total of 44 papers , involving 9,463 knees , were eligible . Outcomes examined included knee function , survivorship and the reasons for , and incidence of , revision for FB and MB prostheses . R and om effects meta- analysis was employed to obtain pooled revision rate estimates . Where available , cause-specific time to revision was extracted . Results Mean follow-up was 8.7 years for FB and 5.9 years for MB prostheses . There were no other relevant baseline differences . The overall crude revision rate for FB and for MB prostheses was 0.90 ( 95 % confidence interval ( CI ) 0.65–1.21 ) and 1.51 ( 95 % CI 1.11–1.93 ) per 100 component years , respectively . After stratification on follow-up time and age , the revision rates were not substantially different , aside for younger patients in short term from studies with short-term follow-up . Conclusion No essential differences between the two design s were observed . MB and FB UKA design s have comparable revision rates . As our study is based on predominantly observational data , with large variations in reporting st and ards , inferences should be drawn with caution .Level of evidence IV
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"BACKGROUND There is a renewed interest in unicompartmental knee arthroplasty . The present report describes the minimum ten-year results associated with a unicompartmental knee arthroplasty design that is in current use . METHODS Sixty-two consecutive unicompartmental knee arthroplasties that were performed with cemented modular Miller-Galante implants in fifty-one patients were studied prospect ively both clinical ly and radiographically . All patients had isolated unicompartmental disease without patellofemoral symptoms . No patient was lost to follow-up . Thirteen patients ( thirteen knees ) died after less than ten years of follow-up , leaving thirty-eight patients ( forty-nine knees ) with a minimum of ten years of follow-up . The average duration of follow-up was twelve years . RESULTS The mean Hospital for Special Surgery knee score improved from 55 points preoperatively to 92 points at the time of the final follow-up . Thirty-nine knees ( 80 % ) had an excellent result , six ( 12 % ) had a good result , and four ( 8 % ) had a fair result . At the time of the final follow-up , thirty-nine knees ( 80 % ) had flexion to at least 120 degrees . Two patients ( two knees ) with well-fixed components underwent revision to total knee arthroplasty , at seven and eleven years , because of progression of patellofemoral arthritis . At the time of the final follow-up , no component was loose radiographically and there was no evidence of periprosthetic osteolysis . Radiographic evidence of progressive loss of joint space was observed in the opposite compartment of nine knees ( 18 % ) and in the patellofemoral space of seven knees ( 14 % ) . Kaplan-Meier analysis revealed a survival rate of 98.0 % + /- 2.0 % at ten years and of 95.7 % + /- 4.3 % at thirteen years , with revision or radiographic loosening as the end point . The survival rate was 100 % at thirteen years with aseptic loosening as the end point . CONCLUSIONS After a minimum duration of follow-up of ten years , this cemented modular unicompartmental knee design was associated with excellent clinical and radiographic results . Although the ten-year survival rate was excellent , radiographic signs of progression of osteoarthritis in the other compartments continued at a slow rate . With appropriate indications and technique , this unicompartmental knee design can yield excellent results into the beginning of the second decade of use",
"Purpose Unicompartmental knee replacement preserves uninvolved osteocartilaginous and soft tissue structures , thereby allowing a more physiological and early clinical and functional recovery . The aim of this study was to report the results of ZUK unicompartmental fixed metal-back prosthesis and how these results change over time . Methods Between 2005 and 2007 , 80 ZUK prostheses were implanted in 80 patients for unicompartmental osteoarthritis or osteonecrosis . Patients were clinical ly assessed using the International Knee Society scores . Postoperative values of mechanical axis were calculated 12 months after surgery and compared to the preoperative ones . Results The mean International Knee Society knee and function scores improved , respectively , from 46 ± 9 and 54 ± 8 preoperatively to 82 ± 5 and 94 ± 3 at the last follow-up ( P 0.001 ) . Average flexion increased from 110 ° ± 9 ° to 127 ° ± 8 ° ( P reached good clinical outcome very early and remained at the same level . Age did not significantly influence clinical and functional scores . Conclusions High success rates of the modern unicompartmental knee implants depend on the material s and design evolution , improvement of the surgical technique , and the strong restriction of indications . Level of evidence Prospect i ve non-r and omized case-series study , Level IV",
"We present the peak outcome results of the Oxford medial unicompartmental arthroplasty through a minimally invasive surgical incision . This prospect i ve study included 78 Oxford medial unicompartmental knee replacements in 68 patients . At the 2 year review the patients achieved a mean Oxford Knee Score of 38.3 . This was not significantly different to the 2 year results of the phase 2 Oxford knee carried out using a st and ard parapatellar approach when patients achieved a mean OKS of 36.0 . Four unicompartmental knee replacements required revision for unexplained pain , deep infection , aseptic loosening and bearing dislocation . Minimally invasive joint replacement is attractive to both patients and surgeons , but is technically dem and ing with complications inherent to limited access",
"Purpose In a mobile-bearing unicompartmental knee arthroplasty ( UKA ) , stability is of utmost importance to promote knee function and to prevent dislocation of the insert . Gap balancing can be guided by the use of spacers or a tensioner . The goal of this study is to compare laxity of a tension-guided implantation technique versus a spacer-guided technique for medial UKA with a mobile bearing . Also clinical function was compared between the groups . Methods The tension-guided UKA system ( BalanSys ™ , Mathys Ltd , Bettlach , Switzerl and ) was compared with a retrospective group with a spacer-guided system ( Oxford , Biomet Ltd , Bridgend , UK ) . A total of 30 tension-guided medial UKAs were implanted and compared with 35 spacer-guided medial prostheses . In both groups , valgus laxity was measured at least 4 months postoperatively in extension and 70 ° flexion using stress radiographs . Knee Society Scores ( KSS ) were obtained at the 6-month follow-up . Results Valgus laxity in flexion was significantly higher in the tension-guided group compared with the spacer-guided group : 3.9 ° ( SD 1.8 ° ) versus 2.4 ° ( SD 1.2 ° ) , respectively , P extension , valgus laxity was significantly different : 1.8 ° ( SD 1.0 ° ) in the tension-guided group compared with 2.7 ° ( SD 0.9 ° ) in the spacer-guided group ( P between the KSS for the two groups ( n.s . ) . Conclusions The tensor-guided system result ed in significantly more valgus laxity in flexion compared with the spacer-guided system . However , in extension , the situation was reversed : the tension-guided system result ed in less valgus laxity than the spacer-guided system . Clinical ly , there were no differences between the groups . The valgus laxity found with the spacer-guided system better approximates the valgus laxity values of the healthy elderly . Level of evidence Lower quality prospect i ve cohort study ( < 80 % follow-up , patients enrolled at different time points in disease ) , Level II",
" Between May 2001 and May 2003 , 233 consecutive Preservation unicompartmental knee replacements ( UKR ) were performed . Of these , 30 were lateral UKRs ( 13 % ) performed in 12 men and 16 women ( 2 bilateral cases ) with a mean age of 67 years ( range 36–93 years ) . A metal-backed mobile bearing tibial component was used in 13 knees and an all-polyethylene fixed bearing tibial component in 17 knees . The patients were review ed prospect ively at 1 and 2 years . The 2 year results show no difference in range of motion or function between the mobile and fixed bearing versions of the Preservation knee when used on the lateral side . There were three early revisions , all in the mobile bearing group",
"The contraindications for unicompartmental knee replacement ( UKR ) remain controversial . The views of many surgeons are based on Kozinn and Scott 's 1989 publication which stated that patients who weighed more than 82 kg , were younger than 60 years , undertook heavy labour , had exposed bone in the patellofemoral joint or chondrocalcinosis , were not ideal c and i date s for UKR . Our aim was to determine whether these potential contraindications should apply to patients with a mobile-bearing UKR . In order to do this the outcome of patients with these potential contraindications was compared with that of patients without the contraindications in a prospect i ve series of 1000 UKRs . The outcome was assessed using the Oxford knee score , the American Knee Society score , the Tegner activity score , revision rate and survival . The clinical outcome of patients with each of the potential contraindications was similar to or better than those without each contraindication . Overall , 678 UKRs ( 68 % ) were performed in patients who had at least one potential contraindication and only 322 ( 32 % ) in patients deemed to be ideal . The survival at ten years was 97.0 % ( 95 % confidence interval 93.4 to 100.0 ) for those with potential contraindications and 93.6 % ( 95 % confidence interval 87.2 to 100.0 ) in the ideal patients . We conclude that the thresholds proposed by Kozinn and Scott using weight , age , activity , the state of the patellofemoral joint and chondrocalcinosis should not be considered to be contraindications for the use of the Oxford UKR",
"The Oxford mobile-bearing unicompartmental knee replacement ( UKR ) is an effective and safe treatment for osteoarthritis of the medial compartment . The results in the lateral compartment have been disappointing due to a high early rate of dislocation of the bearing . A series using a newly design ed domed tibial component is reported . The first 50 consecutive domed lateral Oxford UKRs in 50 patients with a mean follow-up of three years ( 2.0 to 4.3 ) were included . Clinical scores were obtained prospect ively and Kaplan-Meier survival analysis was performed for different endpoints . Radiological variables related to the position and alignment of the components were measured . One patient died and none was lost to follow-up . The cumulative incidence of dislocation was 6.2 % ( 95 % confidence interval ( CI ) 2.0 to 17.9 ) at three years . Survival using revision for any reason and aseptic revision was 94 % ( 95 % CI 82 to 98 ) and 96 % ( 95 % CI 85 to 99 ) at three years , respectively . Outcome scores , visual analogue scale for pain and maximum knee flexion showed a significant improvement ( p 0.001 ) . The mean Oxford knee score was 43 ( SD 5.3 ) , the mean Objective American Knee Society score was 91 ( SD 13.9 ) and the mean Functional American Knee Society score was 90 ( SD 17.5 ) . The mean maximum flexion was 127 ° ( 90 ° to 145 ° ) . Significant elevation of the lateral joint line as measured by the proximal tibial varus angle ( p = 0.04 ) was evident in the dislocation group when compared with the non-dislocation group . Clinical results are excellent and short-term survival has improved when compared with earlier series . The risk of dislocation remains higher using a mobile-bearing UKR in the lateral compartment when compared with the medial compartment . Patients should be informed about this complication . To avoid dislocations , care must be taken not to elevate the lateral joint line",
"Recently , implant companies have sought to target a more active segment of the population with high-flex implants . Our aim was to compare a successful medial UKA implant with its newer high-flex version . Sixty-one patients ( nonflex , 33 ; high-flex [ HF ] , 28 ) were prospect ively followed after medial UKA with a minimum of 2-year follow-up . Patients were evaluated using Short Form 12 , Western Ontario and McMaster Osteoarthritis ( WOMAC ) , Knee Society Scores , and range of motion ( ROM ) . The HF group exhibited significantly higher WOMAC Physical Function scores at 3-month follow-up and higher WOMAC Pain and SF-12 Mental Component scores at 2-year follow-up ; all other comparisons were not statistically different , including ROM . The HF cohort had significantly higher improvements in Knee Society Function and Knee score at 1- and 2-year follow-up , respectively ; all other comparisons yielded no significant differences in mean improvement from baseline , including ROM or survivorship",
"We prospect ively evaluated a consecutive series of 56 patients with unicompartmental knee arthritis who underwent unicompartmental knee replacement or total knee arthroplasty and received an average of 52months of follow-up . These patients were enrolled in a prospect i ve r and omized clinical trial . There were no significant differences in the pre-operative parameters of both groups . All the patients were followed up and evaluated preoperatively and yearly , the data was collected and statistical analysis was performed . At an average of 52months after surgery the mean Knee Society score was 80.5 ( range : 70 - 100 ) and 78.9 ( range : 70 - 87 ) for Unicompartmental knee replacement and total knee arthroplasty , mean range of postoperative motion for TKA is 115(0)±4(0 ) and 117(0)±7(0 ) for the group of UKA , with the numbers available , the difference between the two groups could not be shown to be significant . The average operation time of UKA and TKA is 68.8min and 81.5min(p ) . Blood drainage after operation had a significant difference between the two groups ( p total knee arthroplasty - all of them within the first 2years of starting the procedure and all of them in relatively young patients . From the study we concluded that mobile bearing UKA can obtain similar clinical effect with TKA by surgeons who have the adequate training and experience . After the learning curve UKA should be considered the primary treatment option for unicompartmental knee arthritis",
"Unicompartmental knee replacement ( UKR ) for anteromedial osteoarthritis is a well-established technique . Numerous clinical outcome studies demonstrate good medium and long-term results . The aim of this prospect i ve study was to compare the complications and short-term clinical outcome of the St. Georg Sled , a fixed bearing UKR , with the Oxford mobile bearing UKR . Outcome at 2 years was assessed using the Bristol knee score and the Oxford knee score ; in addition , complications occurring since formal scoring at 2-year follow-up were recorded . A total of 47 Oxford UKRs and 57 St. Georg Sled UKRs were performed in 91 patients , none of whom were lost to follow-up . At 2 years , both outcome measures were better for the St. Georg Sled Group . The pain component of the Bristol knee score was significantly better for this group ( p-value = 0.013 ) . Three patients in the Oxford group had bearing dislocations and a further four patients required revision ( mean time to revision 3.0 years ) . In the St. Georg Sled group , three patients required revisions ( mean time to revision 3.4 years ) . These results demonstrate that in the short-term , the Oxford mobile bearing prosthesis has a higher re-operation rate and that the St. Georg Sled achieves better pain relief . The functional scores of the two groups were similar",
"As part of the step-wise validation of a new prosthesis ( TMK ) , we previously published the 1 year results of a r and omised controlled trial in patients undergoing bilateral knee replacement [ Price A. , Rees J. , Beard D. , Juszczak E. et al. A mobile-bearing total knee prosthesis compared with a fixed-bearing prosthesis . JBJS B 2003;85-B-1:62 - 7 . ] . Forty patients had the new mobile-bearing prosthesis implanted in one knee and an established fixed-bearing device in the other ( AGC ) . We now report the 3 year status of these patients and , in addition , review a separate multi-centre cohort of 172 patients who had undergone unilateral arthroplasty with the TMK . No significant differences were found in outcome ( American Knee Society Score and Oxford Knee Score ) between the two prostheses . The greater incidence of \" clicking \" in the mobile-bearing knee , reported in the previous review , persisted ( TMK=48 % , AGC=30 % ) . The presence of this mechanical noise was found to have no relationship with outcome in either of the prostheses . The unilateral cohort study showed an acceptable complication rate for the new prosthesis , although some patients reported subjective instability . The method of controlled introduction of the TMK , of which this constitutes a further step , has allowed us to assess the significance of a reported problem ( clicking ) and to provide scientific data from which other surgeons can decide about use of the implant",
"The literature contains limited yet controversial information regarding whether a fixed or a mobile bearing implant should be used in unicompartmental knee arthroplasty ( UKA ) . This r and omized study was to further document the performance and comparison of the two design s. Fifty-six knees in 48 patients ( mean age of 72 years ) undergoing medial UKA were r and omized into a fixed bearing ( Miller/Galante ) or a mobile bearing ( Oxford ) UKA . The 2 year clinical outcomes ( clinical scores ) , radiographic findings , and weight bearing knee kinematics ( assessed using RSA ) were compared between the two groups . The mobile bearing knees displayed a larger and an incrementally increased tibial internal rotation ( 4.3 degrees , 7.6 degrees , 9.5 degrees vs. 3.0 degrees , 3.0 degrees , 4.2 degrees respectively at 30 degrees , 60 degrees , 90 degrees of knee flexion ) compared to the fixed ones . The medial femoral condyle in the mobile bearing knees remained 2 mm from the initial position vs. a 4.2 mm anterior translation in the fixed bearing knees during knee flexion . The contact point in the mobile bearing implant moved 2 mm posteriorly vs. a 6 mm anterior movement in the other group . The mobile bearing knees had a lower incidence of radiolucency at the bone implant interface ( 8 % vs. 37 % , p incidence of lateral compartment OA and progression of OA at patello-femoral joint were equal . No differences were found regarding Knee Society Scores , WOMAC , and SF-36 scores ( p > 0.05 ) . This study indicates that mobile bearing knees had a better kinematics , a lower incidence of radiolucency but not yet a better knee function at 2 years",
"This is a retrospective study comparing the clinical outcomes of mobile vs fixed medial unicompartmental knee replacements . Patients were identified from a prospect ively collected data base . Demographic data and pre- and postoperative outcomes ( Oxford , Western Ontario and McMaster Universities Osteoarthritis Index , Short Form Health Survey-12 , and satisfaction ) were collected-104 knees ( 90 patients ) with minimum 2-years of follow-up : 37 mobile and 67 fixed-bearing . At baseline , the median age was 60 years ( mobile ) and 66 ( fixed ) ; body mass index was significantly higher ( 32 ) for the mobile group than for the fixed ( 28 ) . At follow-up , the groups differed only in the Oxford score : median 83 ( mobile ) and 90 ( fixed ) . There is no difference in outcomes between mobile and fixed unicompartmental knee replacements",
"Between February 1996 and December 1997 , forty consecutive patients with medial compartment knee arthritis were assigned r and omly into two groups . All underwent a unicompartimental knee replacement . The tibial prosthesis in group A ( 20 knees ) had a fixed bearing and in group B ( 20 knees ) a mobile bearing . The average age was 69 . Five in group A and 71 in group B. Pre-operatively , and at an average follow-up of 5.7 years , all the knees were assessed using both a dedicated UKR score specifically developed and adopted by the Italian Orthopaedic Unicompartimental Knee Replacement Users Group ( GIUM ) and the Knee Society Score . During surgery in group B we experienced a medial tibial plateau fracture fixed intra-operatively . One prosthesis in group A required an early revision to a TKR because of a continuous pain without any evident sign of loosening . There were no meniscal dislocations in group B. No statistically significant difference in outcome was observed between the two groups at the latest follow-up"
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BACKGROUND Free provision of tangible goods that may improve health is one approach to addressing discrepancies in health outcomes related to income , yet it is unclear whether providing goods for free improves health . We systematic ally review ed the literature that reported the association between the free provision of tangible goods and health outcomes . METHODS A search was performed for relevant literature in all language s from 1995-May 2017 . Eligible studies were observational and experimental which had at least one tangible item provided for free and had at least one quantitative measure of health . Studies were excluded if the intervention was primarily a service and the free good was relatively unimportant ; if the good was a medication ; or if the data in a study was duplicated in another study . Covidence screening software was used to manage articles for two levels of screening . Data was extracted using an adaption of the Cochrane data collection template . Health outcomes , those that affect the quality or duration of life , are the outcomes of interest . The study was registered with PROSPERO ( CRD42017069463 ) . FINDINGS The initial search identified 3370 articles and 59 were included in the final set with a range of 20 to 252 246 participants . The risk of bias assessment revealed that overall , the studies were of medium to high quality . Among the studies included in this review , 80 health outcomes were statistically significant favouring the intervention , 19 health outcomes were statistically significant favouring the control , 141 health outcomes were not significant and significance was unknown for 28 health outcomes . INTERPRETATION The results of this systematic review provide evidence that free goods can improve health outcomes in certain circumstances , although there were important gaps and limitations in the existing literature
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"Background Approximately 55,000 children in New Zeal and do not eat breakfast on any given day . Regular breakfast skipping has been associated with poor diets , higher body mass index , and adverse effects on children 's behaviour and academic performance . Research suggests that regular breakfast consumption can improve academic performance , nutrition and behaviour . This paper describes the protocol for a stepped wedge cluster r and omised trial of a free school breakfast programme . The aim of the trial is to determine the effects of the breakfast intervention on school attendance , achievement , psychosocial function , dietary habits and food security . Methods / Design Sixteen primary schools in the North Isl and of New Zeal and will be r and omised in a sequential stepped wedge design to a free before-school breakfast programme consisting of non-sugar coated breakfast cereal , milk products , and /or toast and spreads . Four hundred children aged 5 - 13 years ( approximately 25 per school ) will be recruited . Data collection will be undertaken once each school term over the 2010 school year ( February to December ) . The primary trial outcome is school attendance , defined as the proportion of students achieving an attendance rate of 95 % or higher . Secondary outcomes are academic achievement ( literacy , numeracy , self-reported grade s ) , sense of belonging at school , psychosocial function , dietary habits , and food security . A concurrent process evaluation seeks information on parents ' , schools ' and providers ' perspectives of the breakfast programme . Discussion This r and omised controlled trial will provide robust evidence of the effects of a school breakfast programme on students ' attendance , achievement and nutrition . Furthermore the study provides an excellent example of the feasibility and value of the stepped wedge trial design in evaluating pragmatic public health intervention programmes . Trial Registration NumberAustralian New Zeal and Clinical Trials Registry ( ANZCTR ) -",
"Sophie Boisson and colleagues conducted a double-blind , r and omized placebo-controlled trial in Orissa , a state in southeast India , to evaluate the effect of household water treatment in preventing diarrheal illnesses in children aged under five years of age . Please see later in the article for the Editors '",
"In this paper we estimate the causal effects on child mortality from moving into less distressed neighborhood environments . We match mortality data to information on every child in public housing that applied for a housing voucher in Chicago in 1997 ( N=11,848 ) . Families were r and omly assigned to the voucher wait list , and only some families were offered vouchers . The odds ratio for the effects of being offered a housing voucher on overall mortality rates is equal to 1.11 for all children ( 95 % CI 0.54 to 2.10 ) , 1.50 for boys ( 95 % CI 0.72 to 2.89 ) and 0.00 for girls - that is , the voucher offer is perfectly protective for mortality for girls ( 95 % CI 0 to 0.79 ) . Our paper also addresses a method ological issue that may arise in studies of low-probability outcomes - perfect prediction by key explanatory variables",
"Abstract Aims / Introduction The purpose of the study was to determine the feasibility and effect of a reward‐based , task‐ setting strategy for low‐income out patients with type 2 diabetes . Material s and Methods Indigent diabetes out patients without glucometers were eligible to participate in this trial . A total of 132 cases were r and omly recruited . Participants in group B used glucometers for self‐monitoring at no cost . Group A participants could keep the glucometers only if the glycosylated hemoglobin level declined compared with the baseline visit ; for those not achieving a reduction in the glycosylated hemoglobin level , the glucometers would have to be returned . Group C served as the control group without self‐monitoring setout . Diabetes education was provided to all groups . Metabolic indices and self‐management were evaluated after 6 months of follow up . Results Group A had a significant decline in the glycosylated hemoglobin level ( −0.97 % ) and medical costs ( −159 yuan ) compared with the baseline visit , whereas groups B and C had a decrease in the glycosylated hemoglobin levels alone ( −0.62 and −0.57 % , respectively ) . The body mass index did not change significantly in any group . There was a statistical difference in the glycosylated hemoglobin level of group A compared with groups B and C. Self‐management in group A improved the outcome relative to groups B and C. Conclusions This preliminary evidence suggests that the program is feasible , acceptable for improving patient self‐management , and cost‐effective in reducing the glycosylated hemoglobin level and medical costs ",
"OBJECTIVE To study whether service of a free school lunch has an impact on weight development and food intake among pupils at a lower secondary school , and to assess the association between self-perceived school behaviour and food intake . DESIGN A controlled intervention study involving service of a free healthy school lunch to 9th grade pupils took place over 4 months , from January to May 2007 . Weight and height were measured before and after the intervention . The pupils also completed a short FFQ and a question naire concerning self-perceived school behaviour and the classroom environment before and after the intervention . A healthy food score was calculated using the FFQ data . SETTING All 9th grade rs at three different lower secondary schools in southern Norway were invited to participate . One school was r and omly selected as the intervention school . SUBJECTS Fifty-eight pupils ( 91 % ) from the intervention school and ninety-two pupils ( 77 % ) from the control schools participated . RESULTS BMI did not increase among the girls at the intervention school , but increased significantly among the boys at the intervention school and among the control school groups . The healthy food score correlated positively with the trait ' satisfied with schoolwork ' ( P variance in food score could be explained by gender and the trait ' satisfied with schoolwork ' . CONCLUSIONS Serving of a healthy free school lunch to secondary -school pupils may result in restricted weight gain . Further studies are needed to clarify the impact of school meals on overweight and academic performance ",
"Abstract Objective : To measure the effect of giving out free smoke alarms on rates of fires and rates of fire related injury in a deprived multiethnic urban population . Design : Cluster r and omised controlled trial . Setting : Forty electoral wards in two boroughs of inner London , United Kingdom . Participants : Primarily households including elderly people or children and households that are in housing rented from the borough council . Intervention : 20 050 smoke alarms , fittings , and educational brochures distributed free and installed on request . Main outcome measures : Rates of fires and related injuries during two years after the distribution ; alarm ownership , installation , and function . Results : Giving out free smoke alarms did not reduce injuries related to fire ( rate ratio 1.3 ; 95 % confidence interval 0.9 to 1.9 ) , admissions to hospital and deaths ( 1.3 ; 0.7 to 2.3 ) , or fires attended by the fire brigade ( 1.1 ; 0.96 to 1.3 ) . Similar proportions of intervention and control households had installed alarms ( 36/119 ( 30 % ) v 35/109 ( 32 % ) ; odds ratio 0.9 ; 95 % confidence interval 0.5 to 1.7 ) and working alarms ( 19/118 ( 16 % ) v 18/108 ( 17 % ) ; 0.9 ; 0.4 to 1.8 ) . Conclusions : Giving out free smoke alarms in a deprived , multiethnic , urban community did not reduce injuries related to fire , mostly because few alarms had been installed or were maintained . What is already known on this topic In the United Kingdom , residential fires caused 466 deaths and 14 600 non-fatal injuries in 1999 The risk of death from fire is associated with socioeconomic class One study reported an 80 % decline in hospitalisations and deaths from residential fires after free smoke alarms were distributed in an area at high risk , but these results may not apply in other setting s , and evidence from r and omised controlled trials is lacking What this study adds Giving out free smoke alarms in a multiethnic poor urban population did not reduce injuries related to fire or fires Giving smoke alarms away may be a waste of re sources and of little benefit unless alarm installation and maintenance is",
"Summary For people at high risk of hip fracture living in community setting s , providing hip protectors at no cost increased adherence , but the additional effect of an educational programme was limited . Overall , the level of adherence was modest . Introduction The objective of the study was to increase adherence with hip protector use by older people at high risk of hip fracture . The study included two r and omised controlled trials with 308 older people recruited from three hospital rehabilitation wards and 171 older people recruited from the community . Methods Participants were r and omised into three groups . The control group received a brochure about hip protectors . The no cost group were fitted with free hip protectors and asked to use them . The combined group received free hip protectors and education sessions about their use . Adherence with the use of hip protectors at 3 and 6 months after recruitment was measured . Secondary outcomes were falls , fractures and hospitalisations . Results Very few participants in the two control groups bought a hip protector . Overall adherence in the four intervention groups was modest , but higher in the community recruitment setting ( 49 % ) than in the hospital recruitment setting ( 36 % ) at 6 months . In the community recruitment group , at 3 months of follow-up , a significantly higher number of participants in the combined group ( 62 % ) were wearing hip protectors compared to the no cost group ( 43 % , p = 0.04 ) . Five hip fractures occurred during the study , with four sustained whilst not wearing the hip protectors . Conclusion Providing hip protectors at no cost to community living older people at high risk of hip fractures modestly increases initial acceptance and adherence with hip protector use . Additional education may further increase hip protector use in people living in the community in the short term",
"IMPORTANCE Youth in high-poverty neighborhoods have high rates of emotional problems . Underst and ing neighborhood influences on mental health is crucial for design ing neighborhood-level interventions . OBJECTIVE To perform an exploratory analysis of associations between housing mobility interventions for children in high-poverty neighborhoods and subsequent mental disorders during adolescence . DESIGN , SETTING , AND PARTICIPANTS The Moving to Opportunity Demonstration from 1994 to 1998 r and omized 4604 volunteer public housing families with 3689 children in high-poverty neighborhoods into 1 of 2 housing mobility intervention groups ( a low-poverty voucher group vs a traditional voucher group ) or a control group . The low-poverty voucher group ( n=1430 ) received vouchers to move to low-poverty neighborhoods with enhanced mobility counseling . The traditional voucher group ( n=1081 ) received geographically unrestricted vouchers . Controls ( n=1178 ) received no intervention . Follow-up evaluation was performed 10 to 15 years later ( June 2008-April 2010 ) with participants aged 13 to 19 years ( 0 - 8 years at r and omization ) . Response rates were 86.9 % to 92.9 % . MAIN OUTCOMES AND MEASURES Presence of mental disorders from the Diagnostic and Statistical Manual of Mental Disorders ( Fourth Edition ) within the past 12 months , including major depressive disorder , panic disorder , posttraumatic stress disorder ( PTSD ) , oppositional-defiant disorder , intermittent explosive disorder , and conduct disorder , as assessed post hoc with a vali date d diagnostic interview . RESULTS Of the 3689 adolescents r and omized , 2872 were interviewed ( 1407 boys and 1465 girls ) . Compared with the control group , boys in the low-poverty voucher group had significantly increased rates of major depression ( 7.1 % vs 3.5 % ; odds ratio ( OR ) , 2.2 [ 95 % CI , 1.2 - 3.9 ] ) , PTSD ( 6.2 % vs 1.9 % ; OR , 3.4 [ 95 % CI , 1.6 - 7.4 ] ) , and conduct disorder ( 6.4 % vs 2.1 % ; OR , 3.1 [ 95 % CI , 1.7 - 5.8 ] ) . Boys in the traditional voucher group had increased rates of PTSD compared with the control group ( 4.9 % vs 1.9 % , OR , 2.7 [ 95 % CI , 1.2 - 5.8 ] ) . However , compared with the control group , girls in the traditional voucher group had decreased rates of major depression ( 6.5 % vs 10.9 % ; OR , 0.6 [ 95 % CI , 0.3 - 0.9 ] ) and conduct disorder ( 0.3 % vs 2.9 % ; OR , 0.1 [ 95 % CI , 0.0 - 0.4 ] ) . CONCLUSIONS AND RELEVANCE Interventions to encourage moving out of high-poverty neighborhoods were associated with increased rates of depression , PTSD , and conduct disorder among boys and reduced rates of depression and conduct disorder among girls . Better underst and ing of interactions among individual , family , and neighborhood risk factors is needed to guide future public housing policy changes",
"Purpose This study used an experimental design to examine longitudinal changes in subjective quality of life ( QoL ) among homeless adults with mental illness after assignment to different types of supported housing or to treatment as usual ( TAU , no housing or supports through the study ) . We hypothesized that subjective QoL would improve over time among participants assigned to supported housing as compared to TAU , regardless of the type of supported housing received or participants ’ level of need . Methods Participants ( n = 497 ) were stratified by level of need ( “ high ” or “ moderate ” ) and r and omly assigned to Housing First ( HF ) in scattered-site apartments , HF in a congregate setting ( high needs only ) , or TAU . Linear mixed-effects regression was used to model the association between study arm and self-reported QoL at baseline and at 6 and 12 months post-baseline by need level . Results Based on the adjusted overall score on the QoL measure , participants r and omized to HF reported significantly greater overall QoL as compared to TAU , regardless of need level or type of supported housing at both 6 and 12 months post-baseline . Scores on the safety and living situation subscales were significantly greater for both high and moderate need participants assigned to supported housing regardless of type at both 6 and 12 months post-baseline as compared to TAU . Conclusions Despite multiple health and social challenges faced by homeless individuals with mental illness , HF in both scattered-site and congregate models results in significantly greater perceived QoL as compared to individuals who do not receive HF even after a relatively short period of time",
"OBJECTIVE Housing First with assertive community treatment ( ACT ) is a promising approach to assist people with serious mental illness to exit homelessness . The article presents two-year findings from a multisite trial on the effectiveness of Housing First with ACT . METHODS The study design was a r and omized controlled trial conducted in five Canadian cities . A sample of 950 participants with serious mental illness who were absolutely homeless or precariously housed were r and omly assigned to receive either Housing First with ACT ( N=469 ) or treatment as usual ( N=481 ) . RESULTS Housing First participants spent more time in stable housing than participants in treatment as usual ( 71 % versus 29 % , adjusted absolute difference [AAD]=42 % , p treatment-as-usual participants , Housing First participants who entered housing did so more quickly ( 73 versus 220 days , AAD=146.4 , p longer housing tenures at the study end-point ( 281 versus 115 days , AAD=161.8 , p rated the quality of their housing more positively ( adjusted st and ardized mean difference [ASMD]=.17 , p Housing First participants reported higher quality of life ( ASMD=.15 , p better community functioning ( ASMD=.18 , p Housing First participants showed significantly greater gains in community functioning and quality of life in the first year ; however , differences between the two groups were attenuated by the end of the second year . CONCLUSIONS Housing First with ACT is an effective approach in various context s for assisting individuals with serious mental illness to rapidly exit homelessness",
"OBJECTIVES To evaluate the effectiveness of point of use water treatment with flocculent-disinfectant on reducing diarrhoea and the additional benefit of promoting h and washing with soap . METHODS The study was conducted in squatter settlements of Karachi , Pakistan , where diarrhoea is a leading cause of childhood death . Interventions were r and omly assigned to 47 neighbourhoods . Households in 10 neighbourhoods received diluted bleach and a water vessel ; nine neighbourhoods received soap and were encouraged to wash h and s ; nine neighbourhoods received flocculent-disinfectant water treatment and a water vessel ; 10 neighbourhoods received disinfectant-disinfectant water treatment and soap and were encouraged to wash h and s ; and nine neighbourhoods were followed as controls . Field workers visited households at least once a week from April to December 2003 to promote use of the interventions and to collect data on diarrhoea . RESULTS Study participants in control neighbourhoods had diarrhoea on 5.2 % of days . Compared to controls , participants living in intervention neighbourhoods had a lower prevalence of diarrhoea : 55 % ( 95 % CI 17 % , 80 % ) lower in bleach and water vessel neighbourhoods , 51 % ( 95 % CI 12 % , 76 % ) lower in h and washing promotion with soap neighbourhoods , 64 % lower ( 95 % CI 29 % , 90 % ) in disinfectant-disinfectant neighbourhoods , and 55 % ( 95 % CI 18 % , 80 % ) lower in disinfectant-disinfectant plus h and washing with soap neighbourhoods . CONCLUSIONS With an intense community-based intervention and supplies provided free of cost , each of the home-based interventions significantly reduced diarrhoea . There was no benefit by combining h and washing promotion with water treatment",
"Housing First is an effective intervention that ends and prevents homelessness for individuals with severe mental illness and co-occurring addictions . By providing permanent , independent housing without prerequisites for sobriety and treatment , and by offering support services through consumer-driven Assertive Community Treatment teams , Housing First removes some of the major obstacles to obtaining and maintaining housing for consumers who are chronically homeless . In this study , consumers diagnosed with severe mental illness and who had the longest histories of shelter use in a suburban county were r and omly assigned to either one of two Housing First programs or to a treatment-as-usual control group . Participants assigned to Housing First were placed in permanent housing at higher rates than the treatment-as-usual group and , over the course of four years , the majority of consumers placed by both Housing First agencies were able to maintain permanent , independent housing . Results also highlight that providers new to Housing First must be aware of ways in which their practice s may deviate from the essential features of Housing First , particularly with respect to enrolling eligible consumers on a first-come , first-served basis and separating clinical issues from tenant or housing responsibilities . Finally , other aspects of successfully implementing a Housing First program are discussed",
"OBJECTIVE Individuals experiencing homelessness are particularly vulnerable to food insecurity . The At Home/Chez Soi study provides a unique opportunity to first examine baseline levels of food security among homeless individuals with mental illness and second to evaluate the effect of a Housing First ( HF ) intervention on food security in this population . DESIGN At Home/Chez Soi was a 2-year r and omized controlled trial comparing the effectiveness of HF compared with usual care among homeless adults with mental illness , stratified by level of need for mental health services ( high or moderate ) . Logistic regressions tested baseline associations between food security ( US Food Security Survey Module ) , study site , sociodemographic variables , duration of homelessness , alcohol/substance use , physical health and service utilization . Negative binomial regression determined the impact of the HF intervention on achieving levels of high or marginal food security over an 18-month follow-up period ( 6 to 24 months ) . SETTING Community setting s at five Canadian sites ( Moncton , Montreal , Toronto , Winnipeg and Vancouver ) . SUBJECTS Homeless adults with mental illness ( n 2148 ) . RESULTS Approximately 41 % of our sample reported high or marginal food security at baseline , but this figure varied with gender , age , mental health issues and substance use problems . High need participants who received HF were more likely to achieve marginal or high food security than those receiving usual care , but only at the Toronto and Moncton sites . CONCLUSIONS Our large multi-site study demonstrated low levels of food security among homeless experiencing mental illness . HF showed promise for improving food security among participants with high levels of need for mental health services , with notable site differences",
"AIMS To investigate whether availability of glucometer reagents increases the frequency of self-blood glucose monitoring ( SBGM ) and improves glycaemic control in diabetic patients . METHODS Sixty-two insulin-treated diabetic patients were r and omized to two groups , matched for age , gender , education , income , type and duration of diabetes , years of insulin treatment , number of daily insulin injections , and haemoglobin (Hb)A1c . All patients were given a glucometer , but one group ( no cost , NC ) was provided glucometer test strips free of charge . The other group ( control , C ) had to purchase strips as they found it necessary . Both groups of patients were followed longitudinally at 2-monthly intervals for 12 months with measurement of blood glucose and HbA1c , and the frequency of SBGM was determined by downloading the glucometer memory . RESULTS The SBGM frequency was significantly higher in the NC group vs. the C group during the first 4 months ( 2.0 + /- 0.2 tests/day vs. 1.4 + /- 0.1 tests/day , P Mean HbA1c remained stable over the 12 months in the NC group , whereas an increase with time was observed in the C group . The difference in HbA1c between the two groups was significant ( P blood glucose measured at each visit and average glucose recorded by the glucometer were also lower in the NC group vs. the C group ( P HbA1c and SBGM frequency , and HbA1c in patients testing at least twice a day was lower than in those testing less than twice a day ( 8.8 + /- 0.2 % vs. 9.6 + /- 0.2 % , P glucometer strips provided free of charge to patients increased SBGM frequency . The relationship between HbA1c and SBGM frequency supports the view that SBGM is an essential tool in diabetes management",
"Background Following the Chernobyl nuclear disaster of 1986 , vast areas of Ukraine became contaminated with radionuclides . We examined health effects of school-based food intervention for children in a rural region Narodichi , Ukraine , exposed to low-level radiation through diet of locally produced foods . Until 1995 , children received three daily meals with low content of artificial radionuclides which were subsequently reduced to two . Methods Annual health screening data ( 1993–1998 ) were examined using a quasi-experimental regression discontinuity analysis ( n = 947 children ; 3,573 repeated measurements ) . Generalized Estimating Equation models evaluated effect of the food supplementation reduction on hematologic measures and prevalence of anemia , acute respiratory illnesses and diseases of immune system . Results Prior improvement of several hematologic parameters diminished after food supplementation was reduced . From 1995 to 1996 , levels of hemoglobin and erythrocytes decreased from 12.63 ( 95 % CI : 12.56 - 12.71 ) to 12.46 g/dL ( % CI : 12.39 - 12.52 ) and from 4.10 ( 95 % CI : 4.07 - 4.12 ) to 4.02 ( 95 % CI : 4.00 - 4.04 ) × 1012/L , respectively . In agreement , the prevalence ratio ( PR ) of previously declining anemia increased from 0.57 to 1.31 per year ( pinteraction supplementation and hemoglobin levels was modified by residential 137Cs soil levels . After food supply reduction , PR of common cold and bronchitis increased from 1.27 to 2.32 per year ( pinteraction = 0.01 ) and from 1.09 to 1.24 per year ( pinteraction = 0.43 ) , respectively . Conclusions Food supplementation provided by the Ukrainian government likely prevented development of anemia in many of the children residing in the contaminated district . Food supplementation after the community exposure to radioactivity through a diet of locally grown foods should be considered as an effective approach to reduce adverse health effects of radiation ",
"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",
"Whatever the improvement in the protection spectrum of sunscreens ( SCs ) , actual skin protection mainly depends on the way they are used , especially on the quantity applied . This prospect i ve r and omized study assessed how much sun protection factor ( SPF ) labeling , which is hardly underst and able by a layman , and high cost account for misuse of SCs . In three beach resorts in France , 364 individuals were blindly r and omized during their holidays to three arms ( 1 ) free SCs intervention ( FS ) = four types of SCs with their usual SPF label ( 60B-A , 20B-A , 12B-A , 6B-3A ) at free disposal ; ( 2 ) same free SCs with an explicit labeling ( FNL ) , including sunburn protection , likely protection against long-term effects of UV , and possibility to get a tan ; and ( 3 ) no intervention ( NI ) . As compared to FS , FNL increased the quantity of SCs applied , mainly in the minority of people who were not \" tan-seekers \" , reduced sunburns particularly in sun-sensitive individuals ( 25.6 vs 58.3 % , P=0.005 ) , and induced a shift in the level of SCs chosen . Free delivery SCs were associated with a more systematic application of SCs in case of exposure , and a decreased sunburn occurrence , without increase of exposure . These results suggest that a labeling more explicit for the public would result in a better protection in SC users and that cost could be a limiting factor to use SC as often as necessary",
"OBJECTIVE To assess the impact of regularly supplying free fluoride toothpaste regularly to children , initially aged 12 months , and living in deprived areas of the north west of Engl and on the level of caries in the deciduous dentition at 5 - 6 years of age . A further aim was to compare the effectiveness of a programme using a toothpaste containing 440 ppmF ( Colgate 0 - 6 Gel ) with one containing 1,450 ppmF ( Colgate Great Regular Flavour ) in reducing caries . DESIGN R and omised controlled parallel group clinical trial . Clinical data were collected from test and control groups when the children were 5 - 6 years old . SETTING A programme of posting toothpaste with dental health messages to the homes of children initially aged 12 months . Clinical examinations took place in primary schools . PARTICIPANTS 7,422 children born in 3-month birth cohorts living in high caries areas in nine health districts in north west Engl and . Within each district children were r and omly assigned to test or control groups . INTERVENTIONS Toothpaste , containing either 440 ppmF or 1450 ppmF , and dental health literature posted at three monthly intervals to children in test groups until they were aged 5 - 6 years . MAIN OUTCOME MEASURES The dmft index , missing teeth and the prevalence of caries experience . RESULTS An analysis of 3,731 children who were examined and remained in the programme showed the mean dmft to be 2.15 for the group who had received 1,450 ppmF toothpaste and 2.49 for the 440 ppmF group . The mean dmft for the control group was 2.57 . This 16 % reduction between the 1,450 ppmF and control group was statistically significant ( P<0.05 ) . The difference between the 440 ppmF group and control was not significant . Further analyses to estimate the population effect of the programme also confirmed this relationship . CONCLUSION This study demonstrates that a programme distributing free toothpaste containing 1,450 ppmF provides a significant clinical benefit for high caries risk children living in deprived , non-fluori date d districts",
"Summary Background The potential of insecticide-treated bednets ( ITNs ) to contribute to child survival has been well documented in r and omised controlled trials . ITN coverage has increased rapidly in Kenya from 7 % in 2004 to 67 % in 2006 . We aim ed to assess the extent to which this investment has led to improvements in child survival . Methods A dynamic cohort of about 3500 children aged 1–59 months were enumerated three times at yearly intervals in 72 rural clusters located in four districts of Kenya . The effect of ITN use on mortality was assessed with Poisson regression to take account of potential effect-modifying and confounding covariates . Findings 100 children died over 2 years . Overall mortality rates were much the same in the first and second years of the study ( 14·5 per 1000 person-years in the first year and 15·4 per 1000 person-years in the second ) . After adjustment for age , time period , and a number of other possible confounding variables , ITN use was associated with a 44 % reduction in mortality ( mortality rate ratio 0·56 , 95 % CI 0·33–0·96 ; p=0·04 ) . This level of protection corresponds to about seven deaths averted for every 1000 ITNs distributed . Interpretation A combined approach of social marketing followed by mass free distribution of ITNs translated into child survival effects that are comparable with those seen in previous r and omised controlled trials",
"Abstract Objective To assess the effectiveness of safety advice and safety equipment in reducing unintentional injuries for families with children aged under 5 years and living in deprived areas . Design R and omised controlled trial . Setting 47 general practice s in Nottingham . Participants 3428 families with children under 5 . Intervention A st and ardised safety consultation and provision of free and fitted stair gates , fire guards , smoke alarms , cupboard locks , and window locks . Main outcome measures Primary outcome measures were whether a child in the family had at least one injury that required medical attendance and rates of attendance in primary and secondary care and of hospital admission for injury over a two year period . Secondary outcome measures included possession of safety equipment and safety practice s. Results No significant difference was found in the proportion of families in which a child had a medically attended injury ( odds ratio 1.14 , 95 % confidence interval 0.98 to 1.50 ) or in the rates of attendance in secondary care ( incidence rate ratio 1.02 , 0.90 to 1.13 ) or admission to hospital ( 1.02 , 0.70 to 1.48 ) . However , children in the intervention arm had a significantly higher attendance rate for injuries in primary care ( 1.37 , 1.11 to 1.70 , P = 0.003 ) . At both one and two years ' follow up , families in the intervention arm were significantly more likely to have a range of safety practice s , but absolute differences in the percentages were relatively small . Conclusions The intervention result ed in significant improvements in safety practice s for up to two years but did not reduce injuries that necessitated medical attendance . Although equipment was provided and fitted free of charge , the observed changes in safety practice s may not have been large enough to affect injury rates",
"Objective No previous experimental trials have investigated Housing First ( HF ) in both scattered site ( SHF ) and congregate ( CHF ) formats . We hypothesized that CHF and SHF would be associated with a greater percentage of time stably housed as well as superior health and psychosocial outcomes over 24 months compared to treatment as usual ( TAU ) . Methods Inclusion criteria were homelessness , mental illness , and high need for support . Participants were r and omised to SHF , CHF , or TAU . SHF consisted of market rental apartments with support provided by Assertive Community Treatment ( ACT ) . CHF consisted of a single building with supports equivalent to ACT . TAU included existing services and supports . Results Of 800 people screened , 297 were r and omly assigned to CHF ( 107 ) , SHF ( 90 ) , or TAU ( 100 ) . The percentage of time in stable housing over 24 months was 26.3 % in TAU ( reference ; 95 % confidence interval ( CI ) = 20.5 , 32.0 ) , compared to 74.3 % in CHF ( 95 % CI = 69.3 , 79.3 , p Secondary outcomes favoured CHF but not SHF compared to TAU . Conclusion HF in scattered and congregate formats is capable of achieving housing stability among people experiencing major mental illness and chronic homelessness . Only CHF was associated with improvement on select secondary outcomes . Registration Current Controlled Trials : IS RCT N57595077",
"Non-r and omised studies of the effects of interventions are critical to many areas of healthcare evaluation , but their results may be biased . It is therefore important to underst and and appraise their strengths and weaknesses . We developed ROBINS-I ( “ Risk Of Bias In Non-r and omised Studies - of Interventions ” ) , a new tool for evaluating risk of bias in estimates of the comparative effectiveness ( harm or benefit ) of interventions from studies that did not use r and omisation to allocate units ( individuals or clusters of individuals ) to comparison groups . The tool will be particularly useful to those undertaking systematic review s that include non-r and omised studies",
"OBJECTIVES We examined the longitudinal effects of a Housing First program for homeless , mentally ill individuals ' on those individuals ' consumer choice , housing stability , substance use , treatment utilization , and psychiatric symptoms . METHODS Two hundred twenty-five participants were r and omly assigned to receive housing contingent on treatment and sobriety ( control ) or to receive immediate housing without treatment prerequisites ( experimental ) . Interviews were conducted every 6 months for 24 months . RESULTS The experimental group obtained housing earlier , remained stably housed , and reported higher perceived choice . Utilization of substance abuse treatment was significantly higher for the control group , but no differences were found in substance use or psychiatric symptoms . CONCLUSIONS Participants in the Housing First program were able to obtain and maintain independent housing without compromising psychiatric or substance abuse symptoms",
"Research suggests that individuals experiencing homelessness have high rates of overweight and obesity . Unhealthy weights and homelessness are both associated with increased risk of poor health and mortality . Using longitudinal data from 575 participants at the Toronto site of the At Home/Chez Soi r and omized controlled trial , we investigate the impact of receiving a Housing First intervention on the Body Mass Index ( BMI ) and waist circumference of participants with moderate and high needs for mental health support services . The ANCOVA results indicate that the intervention result ed in no significant change in BMI or waist circumference from baseline to 24 months . The findings suggest a need for a better underst and ing of factors contributing to overweight , obesity , and high waist circumference in population s who have histories of housing precarity and experience low-income in t and em with other concerns such as mental illness and addictions . Trial Registration International St and ard R and omized Control Trial Number Register IS RCT",
"Background Little is known about the effectiveness of Housing First ( HF ) among ethnic minority groups , despite its growing popularity for homeless adults experiencing mental illness . This r and omized controlled trial tests the effectiveness of a HF program using rent supplements and intensive case management , enhanced by anti-racism and anti-oppression practice s for homeless adults with mental illness from diverse ethnic minority background s. Methods This unblinded pragmatic field trial was carried out in community setting s in Toronto , Canada . Participants were 237 adults from ethnic minority groups experiencing mental illness and homelessness , who met study criteria for moderate needs for mental health services . Participants were r and omized to either adapted HF ( n = 135 ) or usual care ( n = 102 ) and followed every 3 months for 24 months . The primary study outcome was housing stability ; secondary outcomes included physical and mental health , social functioning , quality of life , arrests and health service use . Intention to treat statistical analyses examined the effectiveness of the intervention compared to usual care . Results During the 24-month study period , HF participants were stably housed a significantly greater proportion of time compared to usual care participants , 75 % ( 95 % CI 70 to 81 ) vs. 41 % ( 95 % CI 35 to 48 ) , respectively , for a difference of 34 % , 95 % CI 25 to 43 . HF also led to improvements in community integration over the course of the study : the change in the mean difference between treatment groups from baseline to 24-months was significantly greater among HF participants compared to those in usual care ( change in mean difference = 2.2 , 95 % CI 0.06 to 4.3 ) . Baseline diagnosis of psychosis was associated with reduced likelihood of being housed ≥ 50 % of the study period ( OR = 0.37 , 95 % CI 0.18 to 0.72 ) . Conclusion Housing First enhanced with anti-racism and anti-oppression practice s can improve housing stability and community functioning among ethnically diverse homeless adults with mental illness . Trial registration International St and ard R and omized Control Trial Number Register Identifier : IS RCT N42520374 , assigned August 18 , 2009",
"Background Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care . However , despite widespread support for the use of mobile health technologies , evidence for its role in health care is sparse . Objective We aim ed to evaluate the association between a mobile phone intervention and perinatal mortality in a re source -limited setting . Methods This study was a pragmatic , cluster-r and omized , controlled trial with primary health care facilities in Zanzibar as the unit of r and omization . At their first antenatal care visit , 2550 pregnant women ( 1311 interventions and 1239 controls ) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery . Twenty-four primary health care facilities in six districts were r and omized to either mobile phone intervention or st and ard care . The intervention consisted of a mobile phone text message and voucher component . Secondary outcome measures included stillbirth , perinatal mortality , and death of a child within 42 days after birth as a proxy of neonatal mortality . Results Within the first 42 days of life , 2482 children were born alive , 54 were stillborn , and 36 died . The overall perinatal mortality rate in the study was 27 per 1000 total births . The rate was lower in the intervention clusters , 19 per 1000 births , than in the control clusters , 36 per 1000 births . The intervention was associated with a significant reduction in perinatal mortality with an odds ratio ( OR ) of 0.50 ( 95 % CI 0.27 - 0.93 ) . Other secondary outcomes showed an insignificant reduction in stillbirth ( OR 0.65 , 95 % CI 0.34 - 1.24 ) and an insignificant reduction in death within the first 42 days of life ( OR 0.79 , 95 % CI 0.36 - 1.74 ) . Conclusions Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in re source -limited setting s. Trial Registration Clinical Trials.gov NCT01821222 ; http://www . clinical trials.gov/ct2/show/NCT01821222 ( Archived by WebCite at http://www.webcitation.org/6NqxnxYn0 )",
"BACKGROUND AND OBJECTIVES : \" Housing First \" has been shown to improve housing stability in homeless individuals with mental illness , but had not been empirically tested in homeless youth . We aim ed to evaluate the effect of \" Housing First \" on housing stability in homeless youth aged 18 to 24 years participating in At Home/Chez Soi , a 24-month r and omized trial of \" Housing First \" in 5 Canadian cities . METHODS : Homeless individuals with mental illness were r and omized to receive \" Housing First \" ( combined with assertive community treatment or intensive case management depending on their level of need ) or treatment as usual . We defined our primary outcome , housing stability , as the percent of days stably housed as a proportion of days for which residence data were available . RESULTS : Of 2148 participants who completed baseline interviews and were r and omized , 7 % ( n = 156 ) were youth aged 18 to 24 years ; 87 received \" Housing First \" and 69 received treatment as usual . In an adjusted analysis , youth in \" Housing First \" were stably housed a mean of 437 of 645 ( 65 % ) days for which data were available compared with youth in treatment as usual , who were stably housed a mean of 189 of 582 ( 31 % ) days for which data were available , result ing in an adjusted mean difference of 34 % ( 95 % confidence interval , 24%–45 % ; P \" Housing First \" was associated with improved housing stability in homeless youth with mental illness . Future research should explore whether adaptations of the model for youth yield additional improvements in housing stability and other outcomes",
"OBJECTIVE Housing First is a groundbreaking approach to ending chronic homelessness among people with mental illness . This article presents one-year findings from a multisite r and omized controlled trial ( RCT ) comparing Housing First with treatment as usual . METHODS The study was a nonblind , parallel-group RCT conducted in five Canadian cities . A sample of 950 high-need participants with severe mental illness , who were either absolutely homeless or precariously housed , was r and omly assigned to Housing First ( N=469 ) or treatment as usual ( N=481 ) . Housing First participants received a rent supplement , assistance to find housing , and assertive community treatment . Treatment-as-usual participants had access to all other existing programs . RESULTS At one-year follow-up , 73 % of Housing First participants and 31 % of treatment-as-usual participants resided in stable housing ( p Improvement in overall quality of life was significantly greater among Housing First participants compared with treatment-as-usual participants ( p Housing First participants also showed greater improvements in community functioning compared with treatment-as-usual participants ( p=.003 , d=.25 , CI=.09-.41 ) . CONCLUSIONS Compared with treatment as usual , Housing First produced greater improvements in housing stability , quality of life , and community functioning after one year of enrollment . The study provides support for adopting Housing First as an approach for ending chronic homelessness among persons with severe mental illness , even if they are actively symptomatic or using substances",
"Lymphoedema of extremities is a major clinical manifestation of lymphatic filariasis . Recurrent episodes of acute dermato-lymphangioadenitis ( ADLA ) in these patients lead to progression of the clinical condition . Studies have documented the effectiveness of regular limb hygiene in reduction in frequency and duration of ADLA . However , no data is available on the effectiveness of limb hygiene alone on reduction of lymphoedema volume and locomotor function of the affected extremities . A total of 93 consecutive patients visiting VCRC Filaria Clinic formed a cohort for the study . The limb hygiene kit was supplied monthly free of cost to the patients . Assessment s of oedema volume , frequency and duration of ADLA and quantitative assessment of locomotor function were carried out at baseline and after 12 months of intervention . All the 93 patients completed the follow-up . A total of 82 ( 88 % ) patients practice d limb hygiene regularly . The practice was higher among patients with higher grade s of lymphoedema . The mean frequency of ADLA reduced from pre-intervention level of 2.4 to 0.8 during 12-month period of intervention in grade I cases , from 3.4 to 1.2 in grade II and from 4.8 to 1.8 in grade III cases . The mean duration ( in days ) for each ADLA episode was reduced from 4 at the rpe-intervention level and 2.5 during the 12-months intervention period . Though ' limb hygiene ' practice d in domiciliary setting s is feasible . Regular practice s result ed in reduction of frequency and duration of ADLA attacks . However , reduction in oedema volume or improvement the locomotor function was not observed during 12 month period",
"OBJECTIVE To determine the effect of a School Breakfast Program on obesity and some cardiovascular risk factors in 6 to 10 year old schoolchildren . MATERIAL AND METHODS A quasi-experimental prospect i ve study was conducted in 2002 - 2003 , in 17 municipalities of Sonora State , Mexico . The intervention group consisted of 254 children participating in a School Breakfast Program ( SBP group ) . The control group ( NSBP group , n=106 ) included children who did not participate in the program . In both groups the body mass index for age ( BMI /age ) and body composition by electrical resistance using bioelectrical bioimpedance analysis ( BIA ) were estimated at the beginning and at the end of a 9-month period . In a subgroup of 264 school-children ( SBP and NSBP children ) , serum cholesterol , triglycerides and fasting glucose were measured at the start and at the end of the program . RESULTS The body mass index in the SBP and NSBP groups was not different at the start or at the end of the school period ( p>0.05 ) . The proportion of overweight and obese children and the percentage fat remained similar in both groups . However , the lean mass increased ( p>0.05 ) at the end of the school period in both groups , and hence , can not be attributed to the program . The biochemical parameters showed no change ( p>0.05 ) in blood glucose , total serum cholesterol , and triglycerides in either group at the end of the school period . CONCLUSIONS Study results showed no evidence of a negative effect of SBP in terms of risk factors for obesity and cardiovascular disease",
"OBJECTIVES to evaluate the effectiveness of a policy of making hip protectors available to residents of nursing homes . DESIGN a cluster r and omised controlled trial of the policy in nursing and residential homes , with the home as the unit of r and omisation . SETTING 127 nursing and residential homes in the greater Belfast area of Northern Irel and . PARTICIPANTS 40 homes in the intervention group ( representing 1,366 occupied beds ) and 87 homes in the control group ( representing 2,751 occupied beds ) . INTERVENTIONS a policy of making hip protectors available free of charge to residents of nursing homes and supporting the implementation process by employing a nurse facilitator to encourage staff in the homes to promote their use , over a 72-week period . MAIN OUTCOME MEASURES the rate of hip fractures in intervention and control homes , and the level of adherence to use of hip protectors . RESULTS there were 85 hip fractures in the intervention homes and 163 in the control homes . The mean fracture rate per 100 residents was 6.22 in the intervention homes and 5.92 in the control homes , giving an adjusted rate ratio for the intervention group compared to the control group of 1.05 ( 95 % CI 0.77 , 1.43 , P = 0.76 ) . Initial acceptance of the hip protectors was 37.2 % ( 508/1,366 ) with adherence falling to 19.9 % ( 272/1,366 ) at 72 weeks . CONCLUSIONS making hip protectors available to residents of nursing and residential homes did not reduce the rate of hip fracture . This research does not support the introduction of a policy of providing hip protectors to residents of nursing homes",
"AIMS Housing First ( HF ) is an established intervention for people experiencing homelessness and mental illness . We compared daily substance use ( DSU ) between HF and treatment as usual ( TAU ) . DESIGN Two concurrent r and omized controlled trials with 24-month follow-up . SETTING Market rental apartments with support provided by Assertive Community Treatment ( ACT ) or Intensive Case Management ( ICM ) ; a single building with on-site supports ( CONG ) ; TAU in Vancouver , Canada . PARTICIPANTS Inclusion criteria were current homelessness and mental illness . Participants were assessed as having either ' high needs ' ( HN ; n = 297 ) or ' moderate needs ' ( MN ; n = 200 ) . MN participants were r and omized to ICM ( n = 100 ) or MN-TAU ( n = 100 ) . HN participants were r and omized to ACT ( n = 90 ) , CONG ( n = 107 ) or HN-TAU ( n = 100 ) . INTERVENTIONS AND COMPARATORS All HF interventions included independent housing with support services , with an emphasis on promoting client choice and harm reduction in relation to substance use . TAU included existing services and support available to homeless adults with mental illness . MEASUREMENTS DSU over 24 and 12 months was derived from the Maudsley Addiction Profile . Also measured were demographics , homelessness history , psychiatric diagnoses , symptom severity , comorbid illnesses and duration of stable housing . FINDINGS Compared with HN-TAU , neither CONG [ adjusted odds ( AOR ) ratio = 0.73 , 95 % confidence interval ( CI ) = 0.39 - 1.37 ] nor ACT ( AOR = 1.22 , 95 % CI = 0.61 - 2.45 ) differed on DSU at 24 months , and MN-TAU did not differ from ICM ( AOR = 0.78 , 95 % CI = 0.37 - 1.63 ) . There were no differences at 12 months , when analyses were restricted to participants who indicated substance use at baseline , or when considering the duration of stable housing . CONCLUSIONS Housing First , an intervention to support recovery for homeless people who have co-occurring mental illness and substance use disorders , did not reduce daily substance use compared with treatment as usual after 12 or 24 months",
"BACKGROUND Simultaneously addressing multiple Millennium Development Goals ( MDGs ) has the potential to complement essential health interventions to accelerate gains in child survival . The Millennium Villages project is an integrated multisector approach to rural development operating across diverse sub-Saharan African sites . Our aim was to assess the effects of the project on MDG-related outcomes including child mortality 3 years after implementation and compare these changes to local comparison data . METHODS Village sites averaging 35,000 people were selected from rural areas across diverse agroecological zones with high baseline levels of poverty and undernutrition . Starting in 2006 , simultaneous investments were made in agriculture , the environment , business development , education , infrastructure , and health in partnership with communities and local governments at an annual projected cost of US$ 120 per person . We assessed MDG-related progress by monitoring changes 3 years after implementation across Millenium Village sites in nine countries . The primary outcome was the mortality rate of children younger than 5 years of age . To assess plausibility and attribution , we compared changes to reference data gathered from matched r and omly selected comparison sites for the mortality rate of children younger than 5 years of age . Analyses were done on a per- protocol basis . This trial is registered with Clinical Trials.gov , number NCT01125618 . FINDINGS Baseline levels of MDG-related spending averaged $ 27 per head , increasing to $ 116 by year 3 of which $ 25 was spent on health . After 3 years , reductions in poverty , food insecurity , stunting , and malaria parasitaemia were reported across nine Millennium Village sites . Access to improved water and sanitation increased , along with coverage for many maternal-child health interventions . Mortality rates in children younger than 5 years of age decreased by 22 % in Millennium Village sites relative to baseline ( absolute decrease 25 deaths per 1000 livebirths , p=0·015 ) and 32 % relative to matched comparison sites ( 30 deaths per 1000 livebirths , p=0·033 ) . INTERPRETATION An integrated multisector approach for addressing the MDGs can produce rapid declines in child mortality in the first 3 years of a long-term effort in rural sub-Saharan Africa . FUNDING UN Human Security Trust Fund , the Lenfest Foundation , Bill & Melinda Gates Foundation , and Becton Dickinson",
"The impact of insecticide-treated bednet use on malaria and anaemia in pregnancy was assessed , as a supplementary study , in a major WHO/TDR-supported bednet trial in northern Ghana between July 1994 and April 1995 . The study area was divided into 96 clusters of compounds , with 48 clusters being r and omly allocated to intervention . All pregnant women were included in the study but the focus was on primigravidae and secundigravidae . 1961 pregnant women were recruited into the study --1033 ( 52.7 % ) in the treated bednet group and 928 ( 47.3 % ) in the no net group . 1806 ( 92.1 % ) had blood taken for malaria microscopy and haemoglobin determination in the third trimester . Pregnancy outcomes were reported for 847 women . The characteristics of women in intervention and control groups were comparable . The odds ratios , with 95 % confidence interval ( CI ) , for different study endpoints were , for Plasmodium falciparum parasitaemia--0.89 ( 0.73 , 1.08 ) , for anaemia--0.88 ( 0.70 , 1.09 ) , for low birthweight (LBW)--0.87 ( 0.63 , 1.19 ) , indicating no benefit for treated bednet use . Effective net use by parity varied from 42 % in primigravidae to 63 % in multigravidae , in spite of free nets and insecticide impregnation . The main reasons for not using a net were warm weather and perceived absence of mosquito biting . Chloroquine use in pregnancy was low and comparable in both groups . Implication s of findings for malaria control in pregnancy and further research are discussed",
"OBJECTIVES We examined the relationship between substance dependence and residential stability in homeless adults with current mental disorders 12 months after r and omization to Housing First programs or treatment as usual ( no housing or support through the study ) . METHODS The Vancouver At Home study in Canada included 2 r and omized controlled trials of Housing First interventions . Eligible participants met the criteria for homelessness or precarious housing , as well as a current mental disorder . Residential stability was defined as the number of days in stable residences 12 months after r and omization . We used negative binomial regression modeling to examine the independent association between residential stability and substance dependence . RESULTS We recruited 497 participants , and 58 % ( n = 288 ) met the criteria for substance dependence . We found no significant association between substance dependence and residential stability ( adjusted incidence rate ratio = 0.97 ; 95 % confidence interval = 0.69 , 1.35 ) after adjusting for housing intervention , employment , sociodemographics , chronic health conditions , mental disorder severity , psychiatric symptoms , and lifetime duration of homelessness . CONCLUSIONS People with mental disorders might achieve similar levels of housing stability from Housing First regardless of whether they experience concurrent substance dependence",
"BACKGROUND There is strong evidence that Housing First interventions are effective in improving housing stability and quality of life among homeless people with mental illness and addictions . However , there is very little evidence on the effectiveness of Housing First in improving substance use-related outcomes in this population . This study uses a r and omized control design to examine the effects of scatter-site Housing First on substance use outcomes in a large urban centre . METHODS Substance use outcomes were compared between a Housing First intervention and treatment as usual group in a sample of 575 individuals experiencing homelessness and mental illness , with or without a co-occurring substance use problem , in the At Home/Chez Soi trial in Toronto , Canada . Generalized linear models were used to compare study arms with respect to change in substance use outcomes over time ( baseline , 6 , 12 , 18 and 24 month ) . RESULTS At 24 months , participants in the Housing First intervention had significantly greater reductions in number of days experiencing alcohol problems and amount of money spent on alcohol than participants in the Treatment as Usual group . No differences between the study arms in illicit drug outcomes were found at 24 months . CONCLUSIONS These findings show that a Housing First intervention can contribute to reductions in alcohol problems over time . However , the lack of effect of the intervention on illicit drug problems suggests that individuals experiencing homelessness , mental illness and drug problems may need additional supports to reduce use . TRIAL REGISTRATION Current controlled trials IS RCT N42520374"
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Context Is radiofrequency catheter ablation a better alternative than medical therapy for patients with atrial fibrillation ? Contribution This systematic review found that radiofrequency ablation after a failed drug course maintained sinus rhythm more often than continuation of drug therapy alone . Some studies found that ablation improved quality of life but did not necessarily reduce stroke rates compared with medical therapy . Fewer than 5 % of patients undergoing ablation reportedly experienced major adverse events , such as pulmonary-vein stenosis or cardiac tamponade . Caution Most available evidence was obtained in middle-age adults with preserved left ventricular function and involved follow-up periods of 1 year or less . The Editors Atrial fibrillation is the most common sustained arrhythmia in clinical practice ( 1 ) . Its prevalence increases with age , from 0.1 % in people younger than 55 years to more than 9 % by 80 years of age ( 2 ) . The heavy burden of atrial fibrillation on morbidity , mortality , and health care re sources creates a pressing need for novel approaches to management . In some patients , adequate pharmacologic slowing of the ventricular response rate ( a rate-control strategy ) is sufficient to control symptoms . However , many patients remain symptomatic from the lack of organized atrial contraction and the persistent irregularity of the ventricular response in atrial fibrillation . In such patients , the appropriate treatment is restoration of normal sinus rhythm , achieved electrically or chemically ( a rhythm-control strategy ) ( 2 ) . Overall , a rhythm-control strategy with antiarrhythmic drugs offered no survival advantage over a rate-control strategy in 1 large trial ( 3 ) . An on-treatment analysis , however , suggested that sinus rhythm was associated with a considerable reduction in the risk for death , although antiarrhythmic drugs result ed in increased mortality ( 4 ) . The benefits of maintaining sinus rhythm with antiarrhythmic drugs appeared to be offset by the serious adverse effects of the drugs . Radiofrequency catheter ablation is a promising approach that offers the benefits of maintaining sinus rhythm without the adverse effects of antiarrhythmic drugs . Catheter ablation for atrial fibrillation is based on the underst and ing that electrical activity emanating from the pulmonary veins frequently serves as a trigger for atrial fibrillation . In the late 1990s , Hassaguerre and colleagues ( 5 ) observed that elimination of local electrograms at these foci with radiofrequency energy reduced the risk for recurrence of atrial fibrillation . Currently , the foundation of most atrial fibrillation ablation procedures is to target and electrically isolate the pulmonary veins ( 6 ) . This may be achieved by delivering lesions immediately outside the ostia of the pulmonary veins or along a wider area in the left atrium encircling the veins . Additional lesion sets have been used to ablate nonpulmonary vein triggers of atrial fibrillation and to target atrial areas thought to be responsible for maintaining atrial fibrillation ( 6 ) . These linear lesions may be created in the posterior left atrium , the roof of the left atrium , the interatrial septum , and the isthmus formed between the mitral annulus and the pulmonary vein or left atrial appendage . The Agency for Healthcare Research and Quality commissioned this report to review the evidence for the clinical effects and safety of radiofrequency catheter ablation for the management of atrial fibrillation . At present , the Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation , put forth by the Heart Rhythm Society and endorsed by several professional organizations , states that the foundation of most atrial fibrillation ablation procedures is to target the pulmonary veins , pulmonary vein antra , or both ( 6 ) . After discussion with a technical expert panel convened for this comparative effectiveness review and in accordance with the Heart Rhythm Society 's consensus statement , we review ed only studies that included the targeting of the pulmonary veins or pulmonary vein antra , with or without the addition of other strategies . Methods We developed and followed a st and ard protocol for all steps of the review . A technical report that describes our methods in detail , including the literature search strategies , results , and conclusions , is published elsewhere ( 7 ) . Key Questions Key questions on the effectiveness of radiofrequency catheter ablation compared with other available treatments ( for example , medical treatment or surgery ) were refined with input from the technical expert panel . The panel advised us that 8-mmtip and irrigated-tip catheters are now the catheters of choice for radiofrequency ablation of atrial fibrillation in the United States . The conventional 4-mmtip catheter is rapidly being phased out of use for this indication . Thus , we limited our review to studies that used 8-mmtip or irrigated-tip catheters as a comparator . The following 3 key questions were formulated : 1 . What is the effect of radiofrequency catheter ablation on short-term ( 6 to 12 months ) and long-term ( > 12 months ) rhythm control ; rates of congestive heart failure ; changes in the size of the left atrium and ventricle ; rates of stroke ; quality of life ; avoiding anticoagulation ; and readmissions for paroxysmal , persistent , and long-st and ing persistent ( chronic ) atrial fibrillation ? 2 . How does the effect of radiofrequency ablation on rhythm control differ among the various techniques used ? 3 . What are the short- and long-term complications and harms associated with radiofrequency ablation ? Data Sources and Selection We search ed MEDLINE and the Cochrane Central Register of Controlled Trials from 2000 to December 2008 for studies of adults with atrial fibrillation who underwent radiofrequency catheter ablation . We combined keywords and Medical Subject Heading terms for atrial fibrillation , pulmonary vein , radiofrequency ablation , and catheter ablation . We limited the search to English- language reports of primary studies in adults that were published in peer- review ed journals . We did not include unpublished data . Six review ers screened titles and abstract s to identify potentially relevant articles . They also examined the full-text articles of the potentially relevant abstract s for inclusion eligibility . We accepted longitudinal studies and excluded case series . We included r and omized trials of any sample size . For pragmatic reasons , we restricted the sample sizes in nonr and omized studies . For nonr and omized comparative studies and casecontrol studies , we included only those with at least 10 patients per intervention group . Noncomparative prospect i ve cohort studies had to have at least 50 patients receiving radiofrequency catheter ablation , and retrospective cohort studies must have had at least 100 patients . We included studies of adults ( 18 years of age ) with paroxysmal , persistent , or permanent or chronic atrial fibrillation . We accepted the definitions of the various types of atrial fibrillation used by the study authors , using the terms permanent and chronic atrial fibrillation as reported in the individual studies , even though the definitions varied . Notably , the consensus statement on radiofrequency catheter ablation for the treatment of atrial fibrillation published by the Heart Rhythm Society in 2007 no longer used the term chronic , instead adopting the term long-st and ing persistent for continuous atrial fibrillation lasting more than 1 year ( 6 ) . For a study to be included , at least 80 % of the patients had to be treated with first-time radiofrequency ablation for atrial fibrillation . We excluded studies that were limited to patients with congenital heart disease , hypertrophic cardiomyopathy , or the WolffParkinsonWhite syndrome . The intervention of interest was catheter-directed radiofrequency ablation of the left atrium to prevent atrial fibrillation by using an 8-mmtip or irrigated-tip catheter . We included studies that compared 4-mmtip catheters to other catheters , but not studies that evaluated only 4-mmtip catheters . Radiofrequency ablation could be used as first- or second-line treatment ( that is , before or after a course of antiarrhythmic drugs ) and with or without concurrent antiarrhythmic drugs . We included studies of radiofrequency ablation strategies in which the explicit or intended goal was targeting of the pulmonary veins or pulmonary vein antra , with or without additional ablation . We did not evaluate cryoablation or microwave ablation . We included only studies that reported outcomes of interest at 6 months or more after the initial intervention or that reported adverse events at any time . Outcomes of interest included rhythm control , congestive heart failure , changes in the size of the left atrium or ventricle , stroke , quality -of-life measures , avoidance of anticoagulation , readmissions , and re interventions for atrial fibrillation . We excluded arrhythmia outcomes that occurred during the blanking period , which is defined as a postprocedure period ( typically between 1 and 3 months ) during which an episode of atrial fibrillation was not considered a recurrence . Data Extraction and Quality Assessment Data from each study were extracted by 1 of 4 review ers and were confirmed by a clinical cardiac electrophysiologist author . The extracted data included information on patient characteristics , ablation characteristics ( for example , type of catheter tip , verification of electrical isolation , and ablation techniques ) , other interventions , outcomes , study design , and quality . For most outcomes , 6-month , 12-month , and last-reported-time-point data were included . All mortality and adverse event data were extracted . We used predefined criteria to grade study quality as good , fair , or poor . We also rated the strength of the overall body of evidence for each key question as high , moderate , low , or insufficient ( Appendix Table ) . The quality assessment and strength of the overall
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"OBJECTIVES We sought to test how catheter ablation using an open irrigation catheter ( OIC ) compares with st and ard catheters for pulmonary vein antrum isolation . BACKGROUND Open irrigation catheters have the advantage of delivering greater power without increasing the temperature of the catheter tip , which enables deeper and wider lesions without the formation of coagulum on catheters . METHODS Catheter ablation was performed using an 8-mm catheter ( 8MC ) or an OIC . Patients were r and omized to 3 groups : 8MC ; OIC-1 , OIC with a higher peak power ( 50 W ) ; and OIC-2 , OIC with lower peak power ( 35 W ) . RESULTS A total of 180 patients were r and omized to the 3 treatment strategies . Isolation of pulmonary vein antra was achieved in all patients . The freedom from atrial fibrillation was significantly greater in the 8MC and OIC-1 groups compared with the OIC-2 group ( 78 % , 82 % , and 68 % , respectively , p = 0.043 ) . Fluoroscopy time was lower in OIC-1 compared with OIC-2 and 8MC ( 28 + /- 1 min , 53 + /- 2 min , and 46 + /- 2 min , respectively , p = 0.001 ) . The mean left atrium instrumentation time was lower in the OIC-1 compared with the OIC-2 and 8MC groups ( 59 + /- 3 min , 90 + /- 5 min , and 88 + /- 4 min , respectively , p = 0.001 ) . However , there was a greater incidence of \" pops \" in the OIC-1 ( 100 % , 0 % , 0 % , p pericardial effusion ( 20 % , 0 % , 0 % , p gastrointestinal complaints ( 17 % in OIC-1 , 3 % in 8MC , and 5 % in OIC-2 , p = 0.031 ) . CONCLUSIONS Although there was a decrease in fluoroscopy and left atrium instrumentation time with the use of OIC at higher power , this setting was associated with increased cardiovascular and gastrointestinal complications",
"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",
"Background —This prospect i ve clinical study evaluates the feasibility and efficacy of combined linear mitral isthmus ablation and pulmonary vein ( PV ) isolation in patients with paroxysmal atrial fibrillation ( AF ) . Methods and Results —One hundred consecutive patients ( 13 women ; age 55±10 years ) with drug-refractory , symptomatic paroxysmal AF underwent PV isolation and linear ablation of the cavotricuspid isthmus and the mitral isthmus ( lateral mitral annulus to the left inferior PV ) . They were compared with 100 consecutive patients ( 14 women ; age , 52±10 years ) undergoing PV isolation and cavotricuspid ablation without mitral isthmus ablation . Bidirectional mitral isthmus block was confirmed by demonstrating ( 1 ) a parallel corridor of double potentials during coronary sinus ( CS ) pacing , ( 2 ) an activation detour by pacing either side of the line , and ( 3 ) differential pacing techniques . Isolation of all PVs and cavotricuspid isthmus ablation were performed successfully in all . Mitral isthmus block was achieved in 92 patients after 20±10 minutes of endocardial radiofrequency application and an additional 5±4 minutes of epicardial radiofrequency application from within the CS in 68 , result ing in a conduction delay of 151±26 ms during CS pacing . Thirty-two patients with mitral isthmus ablation compared with 49 without had recurrent atrial arrhythmia ( P=0.02 ) requiring further ablation . At 1 year after the last procedure , 87 patients with mitral isthmus ablation and 69 without ( P=0.002 ) were arrhythmia free without antiarrhythmic drugs , mitral isthmus ablation being the only factor associated with long-term success ( RR for AF recurrence , 0.2 ; CI , 0.1 to 0.4 ; P demonstrable conduction block and is associated with a high cure rate for paroxysmal AF",
"BACKGROUND Recent data have shown that the septum and anterior left atrial ( LA ) wall may contain \" rotor \" sites required for AF maintenance . However , whether adding ablation of such sites to st and ard ICE-guided PVAI improves outcome is not well known . OBJECTIVE To determine if adjuvant anterior LA ablation during PVAI improves the cure rate of paroxysmal and permanent AF . METHODS One hundred AF patients ( 60 paroxysmal , 40 persistent/permanent ) undergoing first-time PVAI were enrolled over three months to receive adjuvant anterior LA ablation ( Group I ) . These patients were compared with 100 r and omly selected , matched first-time PVAI controls from the preceding three months who did not receive adjuvant ablation ( Group II ) . All 200 patients underwent ICE-guided PVAI during which all four PV antra and SVC were isolated . In group I , a decapolar lasso catheter was used to map the septum and anterior LA wall during AF ( induced or spontaneous ) for continuous high-frequency , fractionated electrograms ( CFAE ) . Sites where CFAE were identified were ablated until the local EGM was eliminated . A complete anterior line of block was not a requisite endpoint . Patients were followed up for 12 months . Recurrence was assessed post-PVAI by symptoms , clinic visits , and Holter at 3 , 6 , and 12 months . Patients also wore rhythm transmitters for the first 3 months . Recurrence was any AF/AFL > 1 min occurring > 2 months post-PVAI . RESULTS Patients ( age 56 + /- 11 years , 37 % female , EF 53%+/- 11 % ) did not differ in baseline characteristics between group I and II by design . Group I patients had longer procedure time ( 188 + /- 45 min vs 162 + /- 37 min ) and RF duration ( 57 + /- 12 min vs 44 + /- 20 min ) than group II ( P Overall recurrence occurred in 15/100 ( 15 % ) in group I and 20/100 ( 20 % ) in group II ( P = 0.054 ) . Success rates did not differ for paroxysmal patients between group I and II ( 87 % vs 85 % , respectively ) . However , for persistent/permanent patients , group I had a higher success rate compared with group II ( 82 % vs 72 % , P = 0.047 ) . CONCLUSIONS Adjuvant anterior LA ablation does not appear to impact procedural outcome in patients with paroxysmal AF but may offer benefit to patients with persistent/permanent AF",
"BACKGROUND CartoXP and CartoMerge have been used to treat atrial fibrillation ( AF ) for several years . Our r and omized prospect i ve study compared clinical outcomes of these two versions of three dimensional electroanatomic mapping system in guiding catheter ablation for paroxysmal atrial fibrillation ( PAF ) . METHODS Eighty-one patients with symptomatic , drug refractory PAF were r and omly assigned to CartoMerge group ( n=42 , mean age ( 54.5+/-13.1 ) years , history of AF=3.2 years ) or CartoXP group ( n=39 , mean age ( 59.8+/-15.6 ) years , history of AF = 2.9 years ) . All patients underwent 64-slice computed tomography ( MSCT ) 1 to 3 days prior to ablation procedure . Using CartoMerge(TM ) Image Integration Module , 3D anatomical images of the left atrium ( LA ) and pulmonary veins ( PVs ) derived from MSCT of CartoMerge group were established and merged with the electroanatomical map . The integrated images were used to guide the procedure of circumferential pulmonary vein isolation ( CPVI ) . In the other group , CPVI was guided just by CartoXP . The endpoint of CPVI in both groups was abolition or dissociation of pulmonary vein potentials ( PVPs ) . RESULTS Mapping points to establish the electroanatomical model of the LA/PVs were 48.7+/-13.4 in CartoMerge group and 62.5+/-15.7 in CartoXP group ( P Mean distance between mapping points and the MSCT surfaces in CartoMerge group was ( 1.59+/-0.33 ) mm . Accomplishment of abolition or dissociation of PVPs was achieved 95.2 % in CartoMerge group and 92.3 % in CartoXP group . Duration s of procedure and exposure to X-ray were ( 156+/-25 ) minutes , ( 179+/-21 ) minutes ( P in CartoMerge group and 29 ( 74.4 % ) in CartoXP group ( P>0.50 ) . No patient suffered pulmonary vein stenosis , atrioesophageal fistula , stroke or death . CONCLUSION Compared to CartoXP , CartoMerge shortened the catheter ablation procedure and exposure to X-ray , without affecting the clinical outcomes of circumferential pulmonary vein isolation for the treatment of paroxysmal atrial fibrillation in experienced centres",
"AIMS To investigate the effectiveness of additional substrate modification ( SM ) by left atrial ( LA ) linear lesions as compared with pulmonary vein isolation ( PVI ) alone in patients with persistent atrial fibrillation ( AF ) in a prospect i ve r and omized study . Percutaneous PVI has evolved as an accepted treatment for paroxysmal AF but seemed to be less effective in patients with persistent AF . The benefit of PVI alone and additional linear lesions has not been vali date d in a r and omized study so far . METHODS AND RESULTS Sixty-two patients with persistent AF ( median duration 7 , range 1 - 18 months ) were r and omly assigned to either PVI alone ( n = 30 ) or additional SM ( n = 32 ) consisting of a roof line connecting both left superior and right superior PV and LA isthmus ablation between left inferior PV and mitral annulus . Procedures including SM were performed using a three-dimensional mapping system ( EnSite NavX , St Jude Medical , St Paul , MN , USA ) . Anti-arrhythmic drugs were discontinued within 8 weeks after ablation in both groups . Follow-up included daily trans-telephonic ECG transmitted irrespective of the patient 's symptoms . PVI was successful in 98 % of all targeted veins in both groups . Additional SM did not increase fluoroscopy time ( 72.1+/-18.7 vs. 72.9+/-17.3 min , P=0.92 ) because of the use of three-dimensional navigation in the PVI+SM group . AF recurrences within the first 4 weeks following ablation were more common after PVI alone ( 77 % ) than additional SM ( 44 % , P=0.002 ) . After a follow-up time of 487 ( 429 - 570 ) days , only 20 % of patients undergoing st and alone PVI remained in sinus rhythm when compared with 69 % following PVI combined with SM ( P=0.0001 ) . Two patients assigned to PVI+SM experienced procedure-related complications ( cardiac tamponade and minor stroke ) which resolved without sequelae . CONCLUSION PVI alone is insufficient in the treatment of persistent AF . However , additional left linear lesions increase the success rate significantly . Early AF-relapses are associated with a negative outcome after PVI alone but not following additional SM",
"Background —The modification of atrial fibrillation cycle length ( AFCL ) during catheter ablation in humans has not been evaluated . Methods and Results —Seventy patients undergoing ablation of prolonged episodes of AF were r and omized to pulmonary vein ( PV ) isolation or additional ablation of the mitral isthmus . Mean AFCL was determined at a distance from the ablated area ( coronary sinus ) at the following intervals : before ablation , after 2- and 4-PV isolations , and after linear ablation . Inducibility of sustained AF ( ≥10 minutes ) was determined before and after ablation . Spontaneous sustained AF ( 715±845 minutes ) was present in 30 patients and induced in 26 ( AFCL , 186±19 ms ) . PV isolation terminated AF in 75 % , with the number of PVs requiring isolation before termination increasing with AF duration ( P = 0.018 ) . PV isolation result ed in progressive or abrupt AFCL prolongation to various extents , depending on the PV : to 214±24 ms ( P increase in AFCL ( 30±17 versus 14±11 ms ; P = 0.005 ) and the decrease in fragmentation ( 30.0±26.8 % to 10.3±14.5 % ; P prolonged AFCL , with a greater prolongation in patients with AF termination ( 44±13 versus 22±23 ms ; P = 0.08 ) . Sustained AF was noninducible in 57 % after PV isolation and in 77 % after linear ablation . At 7±3 months , 74 % with PV isolation and 83 % with linear ablation were arrhythmia free without antiarrhythmics , which was significantly associated with noninducibility ( P = 0.03 ) with a recurrence rate of 38 % and 13 % in patients with and without inducibility , respectively . Conclusions —AF ablation results in a decline in AF frequency , with a magnitude correlating with termination of AF and prevention of inducibility that is predictive of subsequent clinical outcome",
"CONTEXT Medical evidence may be biased over time if completion and publication of r and omized efficacy trials are delayed when results are not statistically significant . OBJECTIVE To evaluate whether the time to completion and the time to publication of r and omized phase 2 and phase 3 trials are affected by the statistical significance of results and to describe the natural history of such trials . DESIGN Prospect i ve cohort of r and omized efficacy trials conducted by 2 trialist groups from 1986 to 1996 . SETTING Multicenter trial groups in human immunodeficiency virus infection sponsored by the National Institutes of Health . PATIENTS A total of 109 efficacy trials ( total enrollment , 43708 patients ) . MAIN OUTCOME MEASURES Time from start of enrollment to completion of follow-up and time from completion of follow-up to peer- review ed publication assessed with survival analysis . RESULTS The median time from start of enrollment to publication was 5.5 years and was substantially longer for negative trials than for results favoring an experimental arm ( 6.5 vs 4.3 years , respectively ; P ratio for time to publication for positive vs negative trials , 3.7 ; 95 % confidence interval [ CI ] , 1.8 - 7.7 ) . This difference was mostly attributable to differences in the time from completion to publication ( median , 3.0 vs 1.7 years for negative vs positive trials ; P<.001 ) . On average , trials with significant results favoring any arm completed follow-up slightly earlier than trials with nonsignificant results ( median , 2.3 vs 2.5 years ; P=.045 ) , but long-protracted trials often had low event rates and failed to reach statistical significance , while trials that were terminated early had significant results . Positive trials were su bmi tted for publication significantly more rapidly after completion than were negative trials ( median , 1.0 vs 1.6 years ; P=.001 ) and were published more rapidly after su bmi ssion ( median , 0.8 vs 1.1 years ; P=.04 ) . CONCLUSION Among r and omized efficacy trials , there is a time lag in the publication of negative findings that occurs mostly after the completion of the trial follow-up",
"Background —Atrial flutter ( AFL ) and atrial fibrillation ( AF ) frequently coexist in the same patient . Recently it has been demonstrated that the triggers for both AF and AFL may originate in the pulmonary veins ( PVs ) . We hypothesized that in patients with both AF and typical AFL , pulmonary vein – left atrial junction ( PV-LAJ ) disconnection may eliminate both arrhythmias . Methods and Results —Consecutive patients with documented symptomatic AF and typical AFL were r and omly assigned to have PV-LAJ disconnection combined with cavotricuspid isthmus ( CTI ) ablation ( group 1 , n=49 ) or PV-LAJ disconnection alone ( group 2 , n=59 ) . Within the first 8 weeks after ablation , 32 of the group 2 patients had typical AFL documented , whereas none was seen in group 1 . Twenty of these 32 converted to sinus rhythm after initiating antiarrhythmic drugs ( AADs ) . Twelve were cardioverted , and AADs were started . After 8 weeks , all AADS were stopped , and only 3 patients continued to have recurrent sustained typical AFL that was eliminated by CTI ablation . Beyond 8 weeks of follow-up , 7 patients in group 1 and 6 patients in group 2 ( 14 % and 11 % , respectively ) continued to have AF . Ten of these 13 patients underwent a repeat PV-LAJ disconnection procedure and were cured . The remaining 3 remained in normal sinus rhythm while taking AADs . Conclusions —In patients with both AFL and AF , PV-LAJ disconnection alone may be sufficient to control both arrhythmias . CTI block reduced early postablation recurrence of arrhythmias , which in the majority of patients reflects a short-term clinical problem",
"BACKGROUND There are no reports describing the technique , electrophysiological evaluation , and clinical consequences of complete linear block at roofline joining the superior pulmonary veins ( PVs ) in patients with paroxysmal atrial fibrillation ( AF ) . METHODS AND RESULTS Ninety patients with drug-refractory paroxysmal AF undergoing radiofrequency ablation were prospect ively r and omized into 2 ablation strategies : ( 1 ) PV isolation ( n=45 ) or ( 2 ) PV isolation in combination with linear ablation joining the 2 superior PVs ( roofline ; n=45 ) . In both groups , the cavotricuspid isthmus , fragmented peri-PV-ostial electrograms , and spontaneous non-PV foci were ablated . Roofline ablation was performed at the most cranial part of the left atrium ( LA ) with complete conduction block demonstrated during LA appendage pacing by the online mapping of continuous double potential and an activation detour propagating around the PVs to activate caudocranially the posterior wall of the LA . The effect of ablation at the LA roof was evaluated by the change in fibrillatory cycle length , termination and noninducibility of AF , and clinical outcome . PV isolation was achieved in all patients with no significant differences in the radiofrequency duration , fluoroscopy , or procedural time between the groups . Roofline ablation required 12+/-6 ( median 11 , range 3 to 25 ) minutes of radiofrequency energy delivery with a fluoroscopic duration of 7+/-2 minutes and was performed in 19+/-7 minutes . Complete block was confirmed in 43 patients ( 96 % ) and result ed in an activation delay that was shorter circumventing the left than the right PVs during LA appendage pacing ( 138+/-15 versus 146+/-25 ms , respectively ; P=0.01 ) . Roofline ablation result ed in a significant increase in the fibrillatory cycle length ( 198+/-38 to 217+/-44 ms ; P=0.0005 ) , termination of arrhythmia in 47 % ( 8/17 ) , and subsequent noninducibility of AF in 59 % ( 10/17 ) of the patients inducible after PV isolation . However , LA flutter , predominantly perimitral , could be induced in 10 patients ( 22 % ) after roofline ablation . At 15+/-4 months , 87 % of the roofline group and 69 % with PV isolation alone are arrhythmia free without antiarrhythmics ( P=0.04 ) . CONCLUSIONS This prospect i ve r and omized study demonstrates the feasibility of achieving complete linear block at the LA roof . Such ablation result ed in the prolongation of the fibrillatory cycle , termination of AF , and subsequent noninducibility and is associated with an improved clinical outcome compared with PV isolation alone",
"Background — Pulmonary vein ( PV ) isolation is a promising new treatment for atrial fibrillation ( AF ) . We hypothesized that isolation of large areas around both ipsilateral PVs with verification of conduction block is more effective than the isolation of each individual PV . Methods and Results — A total of 110 patients , 67 with paroxysmal AF and 43 with persistent AF , were r and omly assigned to undergo either isolation of each individual PV or isolation of large areas around both ipsilateral PVs . The isolation of each individual PV was an electrophysiologically guided , ostial segmental ablation with a 64-pole basket catheter or a 20-pole circular mapping catheter ( group I ) . Isolation of large areas was performed around the 2 ipsilateral veins with a nonfluoroscopic navigation system and a circular 20-pole mapping catheter for verification of conduction block ( group II ) . In both groups , an irrigated-tip ablation catheter ( 25 to 35 W ) was used to achieve complete isolation . Procedure and ablation times were longer in group II , whereas fluoroscopic time was significantly shorter ( P≤0.001 ) . After a follow-up period of 15±4 months , 27 patients in group I ( 49 % ) and 37 patients in group II ( 67 % ) remained free of symptoms of AF and had no AF or atrial flutter during repetitive Holter monitoring without antiarrhythmic drug treatment after a single procedure ( P≤0.05 ) . Conclusions — The rate of success was significantly higher and fluoroscopy times were significantly lower in the group with large isolation areas around both ipsilateral PVs than in those who underwent individual PV isolation",
"Background Atrial fibrillation ( AF ) increases the risk of atrioembolic stroke . However , the role of anticoagulation therapy ( OAT ) in preventing cerebrovascular accidents ( CVA ) after intracardiac echocardiography-guided pulmonary vein antrum isolation ( ICE-PVAI ) is still unclear . In the present study , we evaluated the incidence of CVA following the interruption of OAT 3 months after ICE-PVAI . Methods Between September 2002 and March 2004 , 85 consecutive patients ( 72 men , mean age 62 ± 7 years ) underwent ICE-PVAI for symptomatic drug-refractory AF . Heart disease was present in 61 patients ( 72 % ) ( left ventricular ejection fraction = 58 ± 6 % , LA diameter 44 ± 6 mm ) . Eighty-five consecutive patients who underwent electrical cardioversion ( EC ) for AF , matched for age , sex and heart disease , served as a control group . After 3 months , OAT was stopped unless one of the following conditions was observed : ( i ) AF-recurrence ; ( ii ) severe pulmonary vein stenosis ; ( iii ) non-good atrial contractility on transesophageal echocardiography ; or ( iv ) other indications for OAT . Results In the study group , OAT was stopped after 3 months in 77 patients ( 90 % ) and no CVA occurred during the remaining follow-up ( 15 ± 7 months ) . In the control group , 1 month after EC , OAT was stopped by the referring physician in 29 patients ( 34 % ) . A stroke occurred in five patients ( 6 % ) ( P = 0.09 ; mean P = 0.059 ) during follow-up . In two of these ( 2 % ) , the stroke was fatal . Conclusions Stopping OAT 3 months after ICE-PVAI seems to be safe in patients without AF recurrences after the first 3 months following ablation . Further r and omized-controlled studies are needed to confirm these preliminary data",
"OBJECTIVES To evaluate supplementary cavotricuspid isthmus ( CTI ) ablation as an adjunct to atrial fibrillation ( AF ) ablation in selected patients . BACKGROUND It is unclear whether routine CTI ablation is beneficial in all patients undergoing AF ablation . METHODS AND RESULTS In patients undergoing AF ablation , additional CTI block was created only for those with typical atrial flutter ( Afl ) before or during the ablation . Out of 188 consecutive patients ( 108 male , 56 + /- 9 years ) , 75 underwent CTI ablation ( Group CTI+ ) and left atrial ( LA ) ablation ( circular mapping-guided extensive pulmonary vein isolation in all and linear LA ablation when required ) , while 113 underwent LA ablation alone ( Group CTI- ) . Group CTI+ patients had smaller LA and less frequently persistent/permanent AF and linear LA ablation . Over a follow-up of 30 + /- 10 months , complications ( 4 % vs 5 % , P = NS ) , typical Afl occurrence ( 1.3 % and 2.6 % , P = NS ) and AF recurrence ( 25 % and 28 % , P = NS ) were similar . Atypical Afl was more common in Group CTI- ( 4 vs 14 % , P = 0.026 ) . Eighty-two percent and 79 % of patients in Groups CTI+ and CTI- , respectively , remained arrhythmia free in stable sinus rhythm without antiarrhythmic drug treatment ( P = NS ) . CONCLUSIONS Avoiding supplementary CTI ablation in AF ablation patients without evidence of typical flutter does not result in a higher incidence of typical Afl . Despite more persistent/permanent AF and larger LA in patients without evidence of typical flutter , a strategy of selective supplementary ablation result ed in similar and low AF recurrence rates in the group without CTI ablation compared with the group with CTI ablation",
"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 Left atrial ( LA ) circumferential ablation has been reported to eliminate atrial fibrillation ( AF ) . Whether an ablation without encirclement of the pulmonary veins ( PVs ) is as effective as LA circumferential ablation is not clear . OBJECTIVES The purpose of this study was to compare the efficacy of LA circumferential ablation and nonencircling linear ablation in patients with chronic AF . METHODS Eighty patients with chronic AF were r and omized to undergo LA circumferential ablation ( n = 40 ) or nonencircling linear ablation ( n = 40 ) . In LA circumferential ablation , the PVs were encircled , with additional lines made in the mitral isthmus and posterior wall or roof . In nonencircling linear ablation , 4 + /- 1 ablation lines were created through areas of complex electrograms , with lines in the roof ( 38 ) , anterior wall ( 36 ) , septum ( 40 ) , mitral isthmus ( 32 ) , and posterior annulus ( 6 ) . The endpoint of LA circumferential ablation and nonencircling linear ablation was voltage abatement . RESULTS LA flutter occurred in 15 % after LA circumferential ablation and in 18 % after nonencircling linear ablation ( P = .8 ) . A repeat ablation procedure was performed for recurrent AF in 7 and 11 patients or for atrial flutter in 6 and 4 patients after LA circumferential ablation and nonencircling linear ablation , respectively ( P = .8 ) . At 9 + /- 4 months , the prevalence of AF was 28 % in the LA circumferential ablation and 25 % in the nonencircling linear ablation group ( P = .8 ) . Sixty-eight percent and 60 % of patients were in sinus rhythm and free of AF and atrial flutter in the absence of antiarrhythmic drug therapy after LA circumferential ablation and nonencircling linear ablation , respectively ( P = .5 ) . There were no complications . CONCLUSION Nonencircling linear ablation and LA circumferential ablation are equally efficacious in eliminating chronic AF . However , the advantage of nonencircling linear ablation is that it eliminates the need for ablation along the posterior wall of the LA . Therefore , nonencircling linear ablation may avoid the small but real risk of atrioesophageal fistula formation associated with LA circumferential ablation",
"OBJECTIVES We aim ed to determine the safety and efficacy of pulmonary vein isolation ( PVI ) in atrial fibrillation ( AF ) patients with impaired left ventricular ( LV ) systolic function . BACKGROUND To date , PVI has been performed primarily in patients with normal LV function . Yet , many AF patients have impaired LV systolic function . The outcomes of PVI in patients with impaired LV systolic function are unknown . METHODS We included 377 consecutive patients undergoing PVI between December 2000 and January 2003 . Ninety-four patients had impaired LV function ( ejection fraction [ EF ] The control group was the remaining 283 patients who had a normal EF . End points included AF recurrence and changes in EF and quality of life ( QoL ) . RESULTS Mean EF was 36 % in our study group , compared with 54 % in controls . After initial PVI , 73 % of patients with impaired EF and 87 % of patients with normal EF were free of AF recurrence at 14 + /- 6 months ( p = 0.03 ) . In the study group , there was a nonsignificant increase in EF of 4.6 % and significant improvement in QoL. Complication rates were low and included a 1 % risk of pulmonary vein stenosis . CONCLUSIONS Although the AF recurrence rate after initial PVI in impaired EF patients was higher than in normal EF subjects , nearly three-fourths of patients with impaired EF remained AF-free . Although our sample size was nonr and omized , our results suggest PVI may be a feasible therapeutic option in AF patients with impaired EF . R and omized studies with more patients and longer follow-up are warranted",
"BACKGROUND Catheter ablation procedures for treating atrial fibrillation ( AF ) have dramatically increased since triggers of AF were first described in 1998 . OBJECTIVE We explored changes in patient characteristics in patients referred for catheter ablation of AF over a seven-year period from 1999 through 2005 . METHODS Patient characteristics were examined for all patients undergoing AF ablation from 1999 through 2005 at the University of Pennsylvania Health System ( UPHS ) . The gender of patients undergoing ablation was also compared with out patients seen at UPHS with a primary diagnosis of AF . RESULTS From 1999 to 2005 the number of patients undergoing ablation has increased steadily , from 29 patients in 1999 to 265 patients in 2005 ( P Patients have become older ( 47 to 56 years ; P persistent or permanent AF ( 17 % to 45 % ; P left atrial size ( 4.0 to 4.4 cm ; P antiarrhythmic drugs used prior to ablation ( 3.9 to 2.0 drugs ; P ablation have been predominantly male , with a significantly higher male prevalence than patients seen in the UPHS outpatient primary care clinic with AF ( 77 % vs 59 % male ; P Patients undergoing AF ablation from 1999 to 2005 are older , with larger left atrial size , more persistent/permanent AF , and fewer prior antiarrhythmic agents used . Compared with the gender-specific rates of AF in the population , the majority of patients referred for ablation are men , suggesting a referral bias against this invasive procedure for women . These findings are important for interpreting the outcome of ablation in the current era , and for design ing prospect i ve r and omized trials",
"Background Two important limitations of the data regarding the outcomes of catheter ablation of atrial fibrillation ( AF ) are the short-term follow-up used in most published studies and the lack of single-procedure outcomes . Objective The objective was to report the long-term single-procedure outcomes at our center . Material s and methods The patient population was comprised of 200 consecutive patients who underwent ablation ( 133 men ; age 56 ± 11 years ) . Atrial fibrillation was paroxysmal in 92 ( 46 % ) . Success was defined as absence of symptomatic AF , off antiarrhythmic drug ( AAD ) after a single procedure . Results After a follow-up of 26 ± 11 months , the single-procedure long-term success rate was 28 % with an additional 7 % of patients demonstrating improvement . After including repeat procedures in 64 patients , the overall long-term success rate was 41 % with 11 % demonstrating improvement . Further subgroup analysis of 48 paroxysmal AF patients considered to be optimal c and i date s for the procedure , revealed a long-term success rate of 69 % with an additional 4 % demonstrating improvement . A major complication occurred in 7.9 % of patients . Conclusion The results reveal that the long-term single-procedure success rate of catheter ablation of AF in a cohort of patients with predominantly non-paroxysmal AF is less than 40 % . The inclusion of redo procedures result ed in an improvement in outcomes . A much higher success rate of 69 % was achieved in patients with paroxysmal AF considered to be optimal c and i date s for this procedure . These results make it clear that further advances in the technique of catheter ablation of AF are needed to improve the safety and efficacy of this procedure . In order to be able to compare outcomes of various techniques in differing patient population s , we urge investigators to report long-term single procedure outcomes",
"Background —Circumferential pulmonary vein ablation ( CPVA ) is effective in curing atrial fibrillation ( AF ) , but new-onset left atrial tachycardia ( AT ) is a potential complication . We evaluated whether a modified CPVA approach including additional ablation lines on posterior wall and the mitral isthmus would reduce the incidence of AT after PV ablation . Methods and Results —A total of 560 patients ( 291 men , 52 % ; age , 56.5±7.3 years ) entered the study ; 280 were r and omized to CPVA alone ( group 1 ) and 280 to modified CPVA ( group 2 ) . The primary end point was freedom from AT after the procedure . In group 1 , 28 patients ( 10 % ) experienced new-onset AT , and 41 ( 14.3 % ) experienced recurrent AF . In group 2 , 11 patients ( 3.9 % ) experienced AT , and 36 ( 12.9 % ) had recurrent AF . Group 1 was more likely to experience AT than group 2 ( P=0.005 ) . Freedom from AF after ablation was similar in both groups ( P=0.57 ) . Among those in group 1 , gap-related macroreentrant AT was documented in 23 of the 28 patients ( 82 % ) , and focal AT was found in 5 ( 18 % ) . In group 2 , gap-related macroreentrant AT was found in 8 of the 11 patients ( 73 % ) , and focal AT was seen in 3 ( 27 % ) . Two patients in group 1 and 1 patient in group 2 had both AT and AF . The strongest predictor of AT was the presence of gaps ( P —Modified CPVA is as effective as CPVA in preventing AF but is associated with a lower risk of developing incessant AT ",
"Background Various strategies have been used for atrial fibrillation ( AF ) ablation . It is unclear whether adding linear lesions to pulmonary vein ( PV ) isolation has significant advantages . Objectives We assessed the clinical benefit of adding linear lesions in patients undergoing PV isolation for AF . Methods One hundred patients ( 63 male and 37 female ; mean age of 59 ± 11 years ) with documented paroxysmal AF were included in the study . Patients were r and omized into two groups . The first group underwent PV isolation alone . The second group underwent PV isolation and had two linear lesions created ; one line between the superior PVs , and a second line from the left inferior PV to the mitral valve annulus . Patients ’ clinical progress after the ablation was evaluated and compared at 1 , 3 , and 9 months after their respective ablation procedures . Results The linear lesions group maintained sinus rhythm and had fewer symptoms than the lone PV isolation group ( 86 vs. 58 % , respectively ) ( p to regain sinus rhythm ( 90 vs. 82 % , respectively ) ( p = NS ) , there was no statistical difference between the groups regarding the use of antiarrhythmics , the need for electrical cardioversion , and subjective improvement . Conclusion The addition of linear lesions to PV isolation more effectively achieved sinus rhythm initially and fewer patients required additional management to maintain their rhythm when compared to patients who underwent lone PV isolation . However , at 9 months , the overall results were similar in both groups",
"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 —Segmental ostial catheter ablation ( SOCA ) to isolate the pulmonary veins ( PVs ) and left atrial catheter ablation ( LACA ) to encircle the PVs both may eliminate paroxysmal atrial fibrillation ( PAF ) . The relative efficacy of these 2 techniques has not been directly compared . Methods and Results —Of 80 consecutive patients with symptomatic PAF ( age , 52±10 years ) , 40 patients underwent PV isolation by SOCA and 40 patients underwent LACA to encircle the PVs . During SOCA , ostial PV potentials recorded with a ring catheter were targeted . LACA was performed by encircling the left- and right-sided PVs 1 to 2 cm from the ostia and was guided by an electroanatomic mapping system ; ablation lines also were created in the mitral isthmus and posterior left atrium . The mean procedure and fluoroscopy times were 156±45 and 50±17 minutes for SOCA and 149±33 and 39±12 minutes for LACA , respectively . At 6 months , 67 % of patients who underwent SOCA and 88 % of patients who underwent LACA were free of symptomatic PAF when not taking antiarrhythmic drug therapy ( P = 0.02 ) . Among the variables of age , sex , duration and frequency of PAF , ejection fraction , left atrial size , structural heart disease , and the ablation technique , only an increased left atrial size and the SOCA technique were independent predictors of recurrent PAF . The only complication was left atrial flutter in a patient who underwent LACA . Conclusions —In patients undergoing catheter ablation for PAF , LACA to encircle the PVs is more effective than SOCA",
"BACKGROUND Stepwise segmental pulmonary vein isolation ( SPVI ) and circumferential pulmonary vein isolation ( CPVI ) have been developed to treat patients with atrial fibrillation ( AF ) , but the preferable approach for paroxysmal AF ( PAF ) has not been established . METHODS AND RESULTS One hundred and ten patients with symptomatic PAF were r and omized into a stepwise SPVI group ( n=55 ) or CPVI group ( n=55 ) . Systemic SPVI combined with left atrial linear ablation tailored by inducibility of AF was performed in the stepwise SPVI group . Circumferential linear ablation around the left and right-sided pulmonary veins ( PVs ) guided by 3-dimensional electroanatomic mapping was performed in the CPVI group . The endpoints of ablation are non-induciblity of AF in the stepwise SPVI group and continuity of circular lesions combined with PV isolation in the CPVI group . After the initial procedures , atrial tachyarrhythmis ( ATa ) recurred within the first 3 months in 23 of the 55 patients ( 41.8 % ) who underwent stepwise SPVI and in 20 of the 55 patients ( 36.4 % ) who had CPVI ( p=0.69 ) . Repeat procedures were performed in 7 patients from the stepwise SPVI group and 5 from the CPVI group ( p=0.76 ) . During the 3 - 9 months after the last procedure , 46 patients ( 83.6 % ) from the CPVI group and 43 ( 78.2 % ) from the stepwise SPVI group did not have symptomatic ATa while not taking anti-arrhythmic drugs ( p=0.63 ) . Severe subcutaneous hematoma or PV stenosis occurred in 3 patients . CONCLUSIONS The efficacy of stepwise SPVI is comparable to that of CPVI for patients with PAF",
"BACKGROUND Current atrial fibrillation ( AF ) ablation involves isolation of all pulmonary veins ( PVs ) with or without additional linear lesions . However , whether such extensive ablation is necessary is unclear . OBJECTIVE The purpose of this study was to assess the efficacy of different ablation strategies on long-term AF control . METHODS We prospect ively r and omized patients to undergo isolation of all versus arrhythmogenic PVs ( identified by st and ardized stimulation protocol ) . PV isolation was guided by circular mapping catheter . The endpoint was entry/exit block persisting for > or = 20 minutes . Patients were evaluated at three clinic visits ( at 6 weeks , 6 months , and 1 year ) and multiple transtelephonic monitoring periods . Antiarrhythmic drugs were discontinued at 6 weeks . Primary study endpoint was long-term AF control ( freedom or > 90 % reduction in AF burden off or on previously ineffective antiarrhythmic drugs at 1 year after a single ablation procedure ) . RESULTS Over a 20-month period , 105 patients ( 76 men and 29 women , age 57 + /- 9 years ; paroxysmal AF = 77 ) were r and omized , and 103 patients completed 1-year follow-up ( 51 patients in all-PV arm , 52 patients in arrhythmogenic PV arm ) . The primary endpoint was achieved in 75 ( 73 % ) patients and was similar in patients r and omized to all-PV arm versus arrhythmogenic PV arm [ 38 ( 75 % ) patients vs 37 ( 71 % ) patients , respectively ; odds ratio 1.18 , 95 % confidence interval 0.50 , 2.83 , P = .70 ] . Secondary study endpoints , including freedom from AF off antiarrhythmic drugs , total procedure/fluoroscopy times , and occurrence of serious adverse events , were not different between the two groups . CONCLUSION In a r and omized comparison , isolation of arrhythmogenic veins was as efficacious as empiric isolation of all veins in achieving long-term AF control",
"AIMS Segmental pulmonary vein ( PV ) isolation by radiofrequency ( RF ) catheter ablation has become a curative therapy for atrial fibrillation ( AF ) . However , the long procedure time limits the wide application of this procedure . The aim of the current study was to compare a novel ablation technique with a high power output and short application time vs. a conventional technique using a low power output and long application time . METHODS AND RESULTS The study included 90 consecutive patients ( age 53+/-10 years ; 66 men ) . Segmental PV isolation was performed by irrigated RF catheter ablation in both groups . In the conventional group ( Group 1 , 45 patients ) , the power output was limited to 30 W with a target temperature of 50 degrees C and an RF preset duration of 120 s. In the novel group ( Group 2 , 45 patients ) , the maximum power output was preset to 45 W , with a target temperature of 55 degrees C and duration of 20 s. In Group 2 , a significant reduction in the PV isolation time ( 127+/-57 vs. 94+/-33 min , P mean fluoroscopy time ( 73+/-23 vs. 55+/-16 min , P radiation dose was observed . According to the application time and number , Group 2 showed a reduction in RF application time , but a higher number of RF applications were required for creation of complete PV isolation . During a mean follow-up of 15+/-7 months , a total of 74 % of patients in Group 1 and 76 % of patients in Group 2 demonstrated stable SR . CONCLUSION Segmental PV isolation using a high power output and short application time is safe and effective in PV isolation in patients with AF . This technique can significantly reduce the procedure and fluoroscopy time compared with a low-power output technique",
"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 Catheter ablation has become the first line of therapy in patients with symptomatic recurrent , drug-refractory atrial fibrillation ( AF ) . The occurrence of an atrioesophageal fistula is a rare but serious complication after AF-ablation procedures . This risk is even present during segmental pulmonary vein ( PV ) ablation procedures because the esophagus does frequently have a very close anatomical relationship to the right or left PV ostia . The aim of the present study was to analyze whether the exclusion of areas adjacent to the esophagus does have a significant effect on the success rates after segmental pulmonary vein ablation procedures . METHODS Forty-three consecutive patients with symptomatic paroxysmal AF were enrolled in this study . In all patients , a segmental PV ablation procedure was performed . The procedures were facilitated by a 3D real-time visualization of the circumferential mapping catheter placed in the pulmonary veins using the NavX system ( St. Jude Medical , St. Paul , MN , USA ; open irrigated tip ablation catheter ; 43 degrees C ; 30 W ) . In 21 patients , a complete ostial PV isolation was attempted regardless of the anatomical relationship between the ablation sites and the esophagus ( group A ) . In the remaining 22 patients , the esophagus was marked by a stomach tube and areas adjacent to the esophagus were excluded from the ablation procedure ( group B ) . After discharge , patients were scheduled for repeated visits at the arrhythmia clinic at 1 , 3 , and 6 months after the ablation procedure . RESULTS The segmental pulmonary vein ablation procedure could be performed as planned in all patients . In group A , all pulmonary veins could be isolated successfully in 14 out of 21 patients ( 67 % ) . A mean number of 3.7 pulmonary veins ( SD + /- 0.5 PVs ) were isolated per patient . The main reasons for an incomplete PV isolation were : small diameter of the PVs , side branches close to the ostium , or poorly accessible PV ostia . In group B , all PVs could be isolated successfully in only 12 out of 22 patients ( 55 % ; P = 0.54 ) . A mean number of 3.2 PVs ( SD + /- 0.9 PVs ) were isolated per patient ( P = 0.05 ) . This was mostly due to a close anatomical relationship to the esophagus . The ablation strategy had to be modified in 16/22 patients in group B because of a close anatomical relationship between the left ( n = 10 ) or right ( n = 6 ) PV ostia and the esophagus . After 3 months , the percentage of patients free from an AF recurrence was not significantly different between the two groups ( 90 % vs 95 % ; P = 0.61 ) . After 6 months , there was no significant difference between the success rates either ( 81 % vs 82 % ; P = 1.0 ) . There were no major complications in both groups . CONCLUSIONS The exclusion of areas adjacent to the esophagus results in a moderately higher percentage of incompletely isolated PVs . However , it does not have a significant effect on the AF recurrence rate during short-term and mid-term follow-up",
"AIMS Women have an increased risk for atrial fibrillation (AF)-related complications and there is evidence towards a reduced efficacy of the rhythm control strategy than men . A catheter-based strategy is therefore widely attractive , but the impact of gender on catheter ablation ( CA ) of AF remains undefined . METHODS AND RESULTS We included 221 consecutive patients ( 150 men ) who underwent CA of drug-refractory AF . Gender differences in clinical presentation and outcomes were compared . Women were older ( P = 0.002 ) , had a longer history of AF ( P = 0.04 ) , and were more likely to have hypertension ( P = 0.04 ) . Moreover , a concomitant valvular heart disease tended to be more common in women ( 32.4 vs. 23.3 % ; P = 0.28 ) and left atrium dimensions were significantly larger ( P = 0.003 ) . However , acute success rate and complications rate were similar between genders . After 22.5 + /- 11.8 months of follow-up , the overall freedom from arrhythmia recurrences was similar ( 83.1 vs. 82.7 % in men ) , and a similar improvement in SF-36 quality of life scores was achieved in both groups . CONCLUSION Women are referred for AF ablation later with a more complex clinical pre-operative presentation . Despite this higher risk profile in women , no differences were detected in clinical outcomes . Our findings indicate that CA of AF appears to be safe and effective in women as in men",
"AIMS A detailed appreciation of the left atrial/pulmonary venous ( LA/PV ) anatomy may be important in improving the safety and success of catheter ablation for AF . The aim of this r and omized study was to determine the impact of computed tomographic ( CT ) integration into an electroanatomic mapping ( EAM ) system on clinical outcome in patients undergoing catheter ablation for atrial fibrillation ( AF ) . METHODS AND RESULTS Eighty patients with AF were r and omized to undergo first-time wide encirclement of ipsilateral PV pairs using EAM alone ( 40 patients ) or with CT ( 40 patients , Cartomerge ) . Wide encirclement of the pulmonary veins was performed using irrigated radiofrequency ablation with the electrophysiological endpoint of electrical isolation ( EI ) . The primary endpoint was single-procedure success at 6 month follow up . Acute and long-term procedural outcomes were also determined . There was no significant difference in single procedure success between EAM ( 56 % ) and cavotricuspid isthmus image ( CTI ) ( 50 % ) groups ( P = 0.9 ) . Acute procedural outcomes ( EI , PV reconnection , sinus rhythm restored by ablation in persistent AF ) , fluoroscopy , and procedure duration s ( EI of right PVs , EI of left PVs , total ) did not differ significantly between EAM and CTI groups . CONCLUSION Image integration to guide catheter ablation for AF did not significantly improve the clinical outcome . Achieving PV EI is the critical determinant of procedural success rather than the mapping tools used to achieve it",
"BACKGROUND We conducted a r and omized , controlled trial of circumferential pulmonary-vein ablation for the treatment of chronic atrial fibrillation . METHODS A total of 146 patients with a mean ( + /-SD ) age of 57+/-9 years who had chronic atrial fibrillation were r and omly assigned to receive amiodarone and undergo two cardioversions during the first three months alone ( the control group ) or in combination with circumferential pulmonary-vein ablation . Cardiac rhythm was assessed with daily telephonic transmissions for one year . The left atrial diameter and the severity of symptoms were assessed at 12 months . RESULTS Among the 77 patients assigned to undergo circumferential pulmonary-vein ablation , ablation was repeated because of recurrent atrial fibrillation in 26 percent of patients and atypical atrial flutter in 6 percent . An intention-to-treat analysis showed that 74 percent of patients in the ablation group and 58 percent of those in the control group were free of recurrent atrial fibrillation or flutter without antiarrhythmic-drug therapy at one year ( P=0.05 ) . Among the 69 patients in the control group , 53 ( 77 percent ) crossed over to undergo circumferential pulmonary-vein ablation for recurrent atrial fibrillation by one year and only 3 ( 4 percent ) were in sinus rhythm without antiarrhythmic-drug therapy or ablation . There were significant decreases in the left atrial diameter ( 12+/-11 percent , P symptom severity score ( 59+/-21 percent , P Sinus rhythm can be maintained long term in the majority of patients with chronic atrial fibrillation by means of circumferential pulmonary-vein ablation independently of the effects of antiarrhythmic-drug therapy , cardioversion , or both . The maintenance of sinus rhythm is associated with a significant decrease in both the severity of symptoms and the left atrial diameter",
"Background —An anatomic approach of left atrial radiofrequency circumferential ablation ( LACA ) to encircle the pulmonary veins is often effective in eliminating paroxysmal atrial fibrillation ( AF ) . However , no electrophysiological end points other than voltage abatement and /or conduction slowing or block across ablation lines have been used . It has been unclear whether noninducibility of AF is a clinical ly useful end point . Methods and Results —In 100 patients with paroxysmal AF ( mean age , 55±10 years ) , LACA to encircle the left- and right-sided pulmonary veins was performed during AF , with additional ablation lines in the posterior left atrium and mitral isthmus , with an 8-mm-tip catheter . After completion of this lesion set , sinus rhythm was present , and AF lasting > 60 seconds was not inducible in 40 patients ( 40 % ; group 1 ) . The 60 patients in whom AF was still present or who still had inducible AF were r and omly assigned to no further ablation ( group 2 ; 30 patients ) or to additional ablation lines along the left atrial septum , roof , and /or anterior wall where there were fractionated electrograms ( group 3 ; 30 patients ) . In group 3 , AF was rendered noninducible in 27 of 30 patients ( 90 % ) . At a 6-month follow-up , 67 % of patients in group 2 were free of AF without drug therapy compared with 86 % of patients in group 3 . ( P=0.05 , log-rank test ) . Left atrial flutter occurred in 17 % and 27 % of patients in each group , respectively ( P=0.3 ) . Conclusions —After LACA in patients with paroxysmal AF , AF usually can be rendered noninducible by additional ablation at sites of fractionated electrograms . Noninducibility of AF attained by additional electrogram-guided left atrial ablation may be associated with a better midterm clinical outcome than when AF is still inducible after LACA alone",
"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 —The objective of this study was to assess the impact of intracardiac echocardiography ( ICE ) on the long-term success and complications in patients undergoing pulmonary vein isolation ( PVI ) for treatment of atrial fibrillation ( AF ) . Methods and Results —Three hundred fifteen patients underwent PVI for treatment of AF . Each patient underwent ostial isolation of all PVs using a cooled-tip ablation catheter . PVI was performed using circular mapping ( CM ) alone ( group 1 , 56 patients ) , CM and ICE ( group 2 , 107 patients ) , and CM and ICE with titration of radiofrequency energy based on visualization of microbubbles by ICE ( group 3 , 152 patients ) . After a mean follow-up time of 417±145 days , 19.6 % ( 11 of 56 ) , 16.8 % ( 18 of 107 ) , and 9.8 % ( 15 of 152 ) of patients in groups 1 , 2 , and 3 experienced recurrence of AF , respectively . Moreover , whereas no group 3 patient experienced severe ( > 70 % ) PV stenosis , severe PV stenosis was documented in 3 ( 3.5 % ) of 56 patients in group 1 and in 2 ( 1.8 % ) of 107 patients in group 2 ( P . No embolic events were detected in group 3 patients . Conclusions —Intracardiac echocardiography improves the outcome of cooled-tip PVI . Power adjustment guided by direct visualization of microbubble formation reduces the risk of PV stenosis and improves long-term cure",
"INTRODUCTION Dormant pulmonary vein ( PV ) conduction can be provoked by adenosine triphosphate ( ATP ) after extensive encircling pulmonary vein isolation ( EEPVI ) . However , the clinical implication of reconnection between the left atrium ( LA ) and isolated PVs provoked by ATP ( ATP-reconnection ) remains unknown . METHODS AND RESULTS We studied the clinical consequences of ATP-reconnection during intravenous isoproterenol infusion ( ISP-infusion ) . EEPVI severs conduction between the LA and ipsilateral PVs at their junction . Radiofrequency energy is applied at a distance from the PV ostia guided by double Lasso catheters placed within the ipsilateral superior and inferior PVs . This study comprised 82 patients ( 67 men , 56 + /- 9 years old ) with atrial fibrillation ( AF ) who underwent injection of ATP during ISP infusion after successful EEPVI ( ATP(+ ) group ) . We compared clinical characteristics of 170 patients who underwent earlier EEPVI prior to our use of ATP injection after successful EEPVI ( ATP(N/D ) group ) with those of ATP(+ ) group patients who underwent one session of EEPVI . ATP-reconnection occurred in 34 ( 41 % ) of 82 ATP(+ ) group patients . Additional radiofrequency applications were performed to eliminate ATP-reconnection in all ipsilateral PVs . Continuous ATP-reconnection of more than 20 seconds duration occurred in six ( 7.3 % ) of 82 patients . A total of 102 ( 60 % ) of 170 patients in the ATP(N/D ) group had no recurrence of AF , whereas 60 ( 73 % ) of 82 ATP(+ ) group patients who underwent only one EEPVI session have had no recurrence of AF in a 6.1 + /- 3.3-month follow-up period ( P = 0.04 ) . CONCLUSION Radiofrequency application for provoked ATP-reconnection may reduce clinical AF recurrence",
"INTRODUCTION This study examines the feasibility of atrial fibrillation ( AF ) ablation using registered three-dimensional computed tomography ( CT ) images of the left atrium with fluoroscopy . METHODS AND RESULTS A total of 50 consecutive patients with symptomatic AF refractory to medical therapy ( 32 paroxysmal , 18 persistent , age 55 + /- 10 years ) were r and omized to undergo a catheter-based AF ablation procedure with or without the CT-fluoroscopy guidance system . All patients underwent preprocedural contrast-enhanced CT imaging and segmentation of the left atrium . For the CT-fluoroscopy group , circumferential lesions encompassing the pulmonary vein ( PV ) antrum and linear lesions along the roof of the left atrium between the superior PVs and the mitral isthmus were created on the CT image , which was registered with real-time fluoroscopy . The registered images were then used to navigate the ablation catheters to the sites of planned ablation . After the ablation sites were completed , any remaining PV potentials were isolated with electrophysiological guidance . In the control patients , the same technique was performed without using the CT-fluoro guidance system . CT scans were accurately registered to fluoroscopic images with minimal manual correction . Operators could navigate catheters on the registered images to preplanned , extraostial sites for ablation . CT-fluoroscopy guidance decreased procedure duration and fluoro times ( P CT-fluoro guidance group and 16 patients ( 64 % ) in the control group have had no recurrence of AF . CONCLUSION CT-fluoroscopic-guided left atrial ablation is feasible and allows appropriate catheter manipulation in the left atrium",
"BACKGROUND The deployment of an ablation line connecting the left inferior PV to the mitral annulus ( mitral isthmus line [ MIL ] ) enhances the efficacy of pulmonary vein disconnection ( PVD ) in preventing atrial fibrillation ( AF ) recurrences . OBJECTIVES To investigate the long-term effect of the additional linear lesion in a prospect i ve r and omized study . METHODS One hundred and eighty-seven patients ( 37 females , mean age : 55 + /- 11 years ) with paroxysmal ( 126 ) or persistent ( 61 patients ) AF , were prospect ively r and omized into two groups : PVD ( group A , 92 patients ) or PVD combined with MIL ( group B , 95 patients ) , performed by means of an irrigated-tip ablation catheter . RESULTS Successful disconnection of all PVs was achieved in all patients . A bidirectional block ( BB ) along the left atrial isthmus was obtained in 72 of 95 ( 76 % ) patients in group B , most of whom required additional RF pulses from within the distal CS . A transient ischemic attack occurred in 1 patient of group A , and a cardiac tamponade occurred in 1 patient of group B. At 1 year , 53 + /- 5 % ( group A ) and 71 + /- 5 % ( group B ) remained arrhythmia free ( P = 0.01 ) ; subgroup analysis highlights a higher improvement among patients with persistent AF ( 74 + /- 9 % vs 36 + /- 9 % ; P sinus rhythm maintenance rate , particularly in patients with persistent AF , without the risk for major complications",
"BACKGROUND The limited efficacy and complications of segmental ostial pulmonary vein isolation ( PVI ) for treating atrial fibrillation ( AF ) have been discussed so , in the present study the feasibility and efficiency of performing segmental pulmonary vein ( PV ) antrum isolation to treat AF were assessed . METHODS AND RESULTS A total of 187 patients with drug-refractory AF ( paroxysmal 120 , persistent 67 ) underwent segmental PVI guided by circumferential 20-electrode catheters ( Lasso ) . Radiofrequency ( RF ) current was delivered either at the ostium using a regular Lasso ( 15 - 20 mm in diameter , 70 patients : Group 1 ) or at the antrum using a larger Lasso ( 25 - 30 mm in diameter , 117 patients : Group 2 ) . A significantly wider region had to be ablated , with a longer RF application time , to isolate all 4 PVs in Group 2 patients than in Group 1 patients . Although the rate of recurrence of AF after the initial session was equal in both groups , a significantly greater number of patients were free from AF after a mean of 1.4 procedures in Group 2 than in Group 1 ( 93 % vs 76 % for paroxysmal AF , 78 % vs 48 % for persistent AF ) . CONCLUSIONS Segmental antral PVI using large-sized Lasso catheters was found to be more effective and safer than ostial PVI for the treatment of AF",
"AIMS The study was intended to assess the prognostic value of inducibility of atrial fibrillation ( AF ) after radio frequency ablation . METHODS AND RESULTS Two hundred and thirty four patients with drug-resistant paroxysmal ( n=165 ) or persistent AF ( n=69 ) underwent either Lasso-guided segmental pulmonary vein isolation ( n=83 ) or CARTO-guided left atrial circumferential ablation ( n=151 ) . After ablation , two attempts to induce AF ( > 1 min ) by decremental coronary sinus stimulation were performed . Patients were followed for at least 6 months ( median : 12.7 months ) . At 6 months of follow-up , 67 % of patients with paroxysmal and 48 % of patients with persistent AF were AF-free . Inducibility of AF was a significant predictor of AF recurrence in univariate [ hazard ratio (HR)=2.32 , P prognostic value of inducibility was present in both patients with paroxysmal ( HR=2.38 , P=0.001 ) and persistent AF ( HR=1.91 , P=0.034 ) and did not significantly differ between both ablation techniques . The sensitivity , specificity , positive , and negative predictive values of the AF induction test to predict the 6-month ablation outcome were 46.7 , 75 , 53.8 , and 69.2 % , respectively . CONCLUSION Inducibility of AF after ablation is a significant predictor of recurrent AF . However , owing to the low diagnostic accuracy of the AF induction test , non-inducibility does not qualify as reliable procedural endpoint",
"BACKGROUND Catheter ablation ( CA ) by wide encirclement of pulmonary veins ( WEPV ) restores sinus rhythm in up to 95 % . Complex PV-left atrial ( LA ) connections make achieving electrical isolation ( EI ) challenging . We examined anatomical and technical features associated with resistance to EI during WEPV in a prospect i ve study . METHODS One hundred one consecutive patients with symptomatic AF underwent first-time CA guided by electroanatomic mapping and CT integration ( Cartomerg ) . Following double-transseptal access , WEPV was performed . After completion of PV encirclement , the line was mapped and where no signal could be obtained , CA was performed inside the WE line at the site of earliest PV breakthrough on the circular mapping catheter . Sites of EI were tagged . Anatomic studies of corresponding regions of the venoatrial junction in 24 adult hearts were performed . RESULTS Sites resistant to EI were located at the inferior quadrant ( P EI was significantly less frequent at the posterior quadrant ( P EI , CA was necessary inside the WE on the intervenous ridge on the right in 51 % and on the left in 41 % . The LPV/LAA ridge was investigated by anatomic studies that demonstrated considerable variation in the narrowest width ( 3 - 23.7 mm ) and transmural thickness ( 1 - 5 mm ) . CONCLUSION Sites of EI after WEPV have a preferential distribution determined by anatomic features . CA on the intervenous ridge is required in a significant proportion of patients to achieve EI . Atrial folds and ridges increase myocardial thickness creating technical and anatomic challenges for achieving transmural lesions",
"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",
"OBJECTIVES This study was design ed to investigate the potential of circumferential pulmonary vein ( PV ) ablation for atrial fibrillation ( AF ) to maintain sinus rhythm ( SR ) over time , thus reducing mortality and morbidity while enhancing quality of life ( QoL ) . BACKGROUND Circumferential PV ablation is safe and effective , but the long-term outcomes and its impact on QoL have not been assessed or compared with those for medical therapy . METHODS We examined the clinical course of 1,171 consecutive patients with symptomatic AF who were referred to us between January 1998 and March 2001 . The 589 ablated patients were compared with the 582 who received antiarrhythmic medications for SR control . The QoL of 109 ablated and 102 medically treated patients was measured with the SF-36 survey . RESULTS Median follow-up was 900 days ( range 161 to 1,508 days ) . Kaplan-Meier analysis showed observed survival for ablated patients was longer than among patients treated medically ( p all-cause mortality , of 0.45 ( 95 % CI , 0.31 to 0.64 ; p morbidities mainly due to heart failure and ischemic cerebrovascular events , and of 0.30 ( 95 % CI , 0.24 to 0.37 ; p AF recurrence . Ablated patients ' QoL , different from patients treated medically , reached normative levels at six months and remained unchanged at one year . CONCLUSIONS Pulmonary vein ablation improves mortality , morbidity , and QoL as compared with medical therapy . Our findings pave the way for r and omized trials to prospect a wider application of ablation therapy for AF",
"AIMS The aim of the study was to investigate the feasibility of performing segmental pulmonary vein ( PV ) isolation guided by the NavX ( Endocardial Solutions , St Jude Medical , Inc. , St Paul , MN , USA ) system without the three-dimensional ( 3D ) geometric reconstruction option and whether the use of NavX system will reduce the radiation exposure and procedure duration . METHODS AND RESULTS The study included 64 patients with symptomatic paroxysmal or permanent atrial fibrillation , in whom PV isolation was performed using fluoroscopic guidance ( n=32 ) or the NavX system ( n=32 ) . Pulmonary vein mapping with a circular mapping catheter allowed the identification and localization of myocardial connections between the PV and the left atrium . PV isolation was performed by radiofrequency ablation of these connections at the atrial aspect of the PV ostium . Primary success rate for isolated PVs did not differ significantly in patients ablated under fluoroscopic guidance vs. those ablated under guidance of NavX system [ 100/107 PVs ( 93.5 % ) vs. 120/124 PV ( 96.8 % ; P = n.s . ) ] . Compared with fluoroscopy guided procedures , NavX-guided procedures showed a significant reduction in the fluoroscopy time ( 75.8+/-24.5 vs. 38.9+/-19.3 min , P total X-ray exposure ( 93.2+/-51.6 vs. 56.6+/-37.9 Gy cm(2 ) , P=0.03 ) , and total procedural time ( 237.7+/-65.4 vs. 188.6+/-62.7 min , P=0.01 ) . The mean follow-up was 9.5+/-3.0 months . One patient in each group was lost to follow-up . Seven-day Holter monitoring showed that 23 of 31 patients ( 74.2 % ) in the NavX-guided group and 21 of 31 patients ( 67.7 % ) in the fluoroscopy-guided group were in sinus rhythm ( P=0.57 ) . CONCLUSION The 3D visualization of the catheters by NavX system allows a rapid and precise visualization of the mapping and ablation catheters at the PV ostia and markedly reduces fluoroscopy time , total X-ray exposure , and procedural duration during PV isolation compared with ablation performed under fluoroscopy guidance",
"Abstract Background : Catheter ablation of atrial fibrillation is a rapidly evolving art . There is currently no consensus as to optimal methodology . We report a sequential experience , during which three distinct ablation techniques were utilized . Methods : A cohort of 112 patients in whom atrial fibrillation onset was precipitated by ectopy arising solely from myocardium investing the pulmonary veins underwent catheter ablation using one of three techniques : focal ( Group A ) ; individual vein encircling ( Group B ) ; vestibule encircling ( Group C ) . In each group , non-fluoroscopic guidance of the mapping and ablation process was provided by the t and em use of CARTORM and intracardiac echocardiography . Results : In all groups , endocardial topography was complex , and ablation electrode-endocardial contact was often unstable . Maximal electrode temperatures were low , despite frequent echocardiographic evidence of myocardial boiling . A significant progression in the number of radiofrequency energy applications between groups A and C was observed . Although acute suppression of atrial fibrillation inducibility was observed uniformly , chronic suppression rates were significantly different : Group A = 47 % ; Group B ; 69 % ; Group C = 87 % . Conclusions : In this non-concurrent cohort , the rate of chronic suppression of atrial fibrillation correlated with the amount of myocardium ablated or electrically isolated . Prospect i ve data will be required to further evaluate whether “ more is better .",
"BACKGROUND Cerebrovascular events are an important complication during pulmonary vein antrum isolation ( PVAI ) . Microembolic signals ( MES ) have been associated with stroke and neurological impairment . However , the incidence of MES during PVAI , and their relationship to microbubble formation and radiofrequency ( RF ) parameters are unknown . OBJECTIVES We sought to assess the relationship between MES , microbubble detection , and neurological outcome and the impact of RF titration strategy on these parameters . METHODS We studied 202 patients in two groups undergoing PVAI using an intracardiac echocardiography (ICE)-guided technique . MES were detected by transcranial Doppler ( TCD ) using insonation of the middle cerebral arteries . The number of microbubbles on ICE were qualitatively labeled as FEW , MODERATE , and SHOWER . In group I ( n = 107 ) , RF output was titrated to avoid microbubble formation and in group II ( n = 95 ) , st and ard power-limited RF output was used . RESULTS TCD detected MES in all 202 patients during PVAI with an average of 1,793 + /- 547 per patient ; 90 % were detected during left atrial ablation . Over 85 % of MES occurred after microbubbles . Group I patients had significantly lower numbers of MES ( 1,015 + /- 438 per patient ) compared to group II patients ( 2,250 + /- 864 per patient ) ( P acute neurological complications versus 0.9 % in group I ( P = 0.10 ) . Patients with clinical events had significantly higher numbers of MES . There were no significant correlations between RF power , temperature , or impedence and MES number . CONCLUSIONS MES directly correlate to the amount of microbubble formation on ICE , and may result in cerebroembolic complications . Titration of RF according to microbubble formation by ICE during PVAI may be important for minimizing the occurrence of MES and possibly acute neurological complications",
"INTRODUCTION Congestive heart failure ( CHF ) and atrial fibrillation ( AF ) are frequently linked , and when associated produce additive deleterious effects . In this prospect i ve study , the effects of catheter ablation for AF in patients with impaired left ventricular ( LV ) function are presented . METHODS Baseline data and clinical outcome have been prospect ively collected in 105 consecutive patients who underwent pulmonary vein ablation for the control of AF . We evaluated 40 patients affected by LV dysfunction with ejection fraction (EF) and compared them to the remaining 65 patients with normal ventricular function in terms of changes in LV function , maintenance of sinus rhythm , and quality of life during follow-up . RESULTS After a mean follow-up of 14+/-2 months , 87 % of patients with impaired LV function and 92 % of patients with normal ventricular function were in sinus rhythm , with or without antiarrhythmic therapy ( P = NS ) . A significant improvement in LVEF and fractional shortening was documented in patients with CHF ( 33+/-2 % vs 47+/-3 % , and 19+/-4 % vs 30+/-3 % , P exercise capacity and quality of life documented better improvements in patients with CHF compared to patients without CHF . CONCLUSIONS Catheter ablation in patients with LV dysfunction is feasible , not associated with higher procedural complications , and provides a significant improvement in LV performance , symptoms , and quality of life during follow-up",
"BACKGROUND Radiofrequency catheter ablation ( RFCA ) for curing atrial fibrillation ( AF ) is often followed by early recurrence and delayed cure , so the present study investigate the predictive factors this in patients with chronic AF . METHODS AND RESULTS Ninety-two consecutive patients ( 70 males ; mean age , 58.7+/-6.4 years ) with chronic AF who underwent RFCA for treatment of symptomatic AF were enrolled . Early recurrence of AF ( ERAF ) occurred in 45 patients after ablation . Not achieving AF termination could predict ERAF ( odds ratio ( OR ) 0.95 ; 95 % confidence interval ( CI ) 0.84 - 1.13 ; p=0.02 ) in multivariate analysis . During a follow-up of 12+/-11 ( range , 5 - 25 ) months , delayed cure occurred in 35.6 % ( 16/45 ) of the patients with ERAF . Left atrial size and AF termination during ablation were related to delayed cure . AF termination was the only independent predictive factor for delayed cure ( OR 1.47 ; 95 % CI 1.05 - 1.87 ; p=0.02 ) . CONCLUSION Not achieving AF termination is the only independent predictor of ERAF . Among patients with ERAF , those with a smaller left atrium and AF termination have a higher probability of delayed cure . AF termination can independently predict delayed cure . These results emphasize the importance of AF termination during ablation for patients with chronic AF",
"INTRODUCTION We performed a prospect i ve study to compare efficacy and safety of both open irrigation tip ( OIT ) technology with intracardiac echo (ICE)-guided energy delivery in patients presenting for PVAI . METHODS AND RESULTS Fifty-three patients presenting for PVAI were r and omized to ablation using an OIT catheter ( Group 1 , 26 patients ; temperature and power were set at 50 degrees and 50 W , respectively , with a saline pump flow rate of 30 mL/min ) or radiofrequency ( RF ) energy delivery under ICE guidance ( Group 2 , 27 patients ; energy was titrated based on microbubbles formation ) . The mean procedure time and fluoroscopy exposure were lower in Group 1 ( 164 + /- 42 min and 7,560 + /- 2,298 microGray m2 vs 204 + /- 47 min and 12,240 + /- 4,356 microGray m2 ; P = 0.005 and 0.008 , respectively ) . Moreover , the duration s of RF lesions applied per PV antrum was lower in Group 1 compared with Group 2 ( 5.1 + /- 2.2 min vs 9.2 + /- 3.2 min , P = 0.03 , respectively ) . Within 24 hours after PVAI in 35.7 % ( all erythema ) of Group 1 and 57.1 % ( 21.4 % erythema and 35.7 % necrosis ) of Group 2 , patients ' esophageal wall changes were documented . After 14 + /- 2 months of follow up , recurrences were documented in 19.2 % of Group 1 and 22.2 % of Group 2 patients . CONCLUSION Although both OIT and ICE-guided energy delivery possess a similar effect in treating AF , OIT seems to be superior in terms of achieving isolation and shortening fluoroscopy exposure . Moreover , a lower incidence of esophageal wall injury was observed utilizing OIT for PVAI",
"OBJECTIVES The aim of this study was to compare -- in patients with persistent and permanent atrial fibrillation (AF)--the efficacy and safety of left atrial ablation with that of a biatrial approach . BACKGROUND Left atrium-based catheter ablation of AF , although very effective in the paroxysmal form of the arrhythmia , has an insufficient efficacy in patients with persistent and permanent AF . METHODS Eighty highly symptomatic patients ( age , 58.6 + /- 8.9 years ) with persistent ( n = 43 ) and permanent AF ( n = 37 ) , refractory to antiarrhythmic drugs , were r and omized to two different ablation approaches guided by electroanatomical mapping . A procedure including circumferential pulmonary vein , mitral isthmus , and cavotricuspid isthmus ablation was performed in 41 cases ( left atrial ablation group ) . In the remaining 39 patients ( biatrial ablation group ) , the aforementioned approach was integrated by the following lesions in the right atrium : intercaval posterior line , intercaval septal line , and electrical disconnection of the superior vena cava . RESULTS During follow-up ( mean duration 14 + /- 5 months ) , AF recurred in 39 % of patients in the left atrial ablation group and in 15 % of patients in the biatrial ablation group ( p = 0.022 ) . Multivariable Cox regression analysis showed that ablation technique was an independent predictor of AF recurrence during follow-up . CONCLUSIONS In patients with persistent and permanent AF , circumferential pulmonary vein ablation , combined with linear lesions in the right atrium , is feasible , safe , and has a significantly higher success rate than left atrial and cavotricuspid ablation alone",
"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 The aim of this study was to compare the outcome of anatomical pulmonary vein ( PV ) radiofrequency ( RF ) ablation with that of an integrated approach ( anatomical with electrophysiological confirmation of PV disconnection ) . METHODS Sixty consecutive patients affected by drug-refractory paroxysmal ( 39 ) , persistent ( 13 ) , and permanent ( 8) atrial fibrillation ( AF ) were assigned to an anatomical ( group A : 30 patients ; 25 male , 5 female , mean age : 55 + /- 7 years ) or integrated approach ( group B : 30 patients ; 26 male , 4 female , mean age : 52 + /- 9 years ) . In all cases , RF ablation was performed by means of the Carto system in order to anatomically create circumferential lines around PVs . In group B , the persistence of PV potentials was then assessed with a multipolar circular catheter . If PV potentials persisted , RF pulses targeting the electrophysiological breakthroughs were delivered to disconnect PVs . RESULTS Total procedure duration , fluoroscopy time , and RF delivery time were similar in both groups : 227 + /- 43 , 50 + /- 23 , and 43 + /- 16 minutes ( group A ) ; 232 + /- 32 , 55 + /- 15 , and 42 + /- 10 minutes ( group B ) , respectively ( ns ) . One asymptomatic PV stenosis and one pericardial effusion occurred in group A and B , respectively . After 15.4 + /- 7.4 months , 17 ( 57 % ) group A patients and 25 ( 83 % ) group B patients were in stable sinus rhythm ( P = 0.02 ) ( RR 1.78 ; 95 % CI : 1.7 - 2.9 ) . CONCLUSIONS PV ablation by means of an integrated anatomical and electrophysiological approach seems more effective than a purely anatomical RF ablation approach . Electrophysiological confirmation of PV disconnection could be a useful marker of successful RF treatment of AF",
"BACKGROUND Noninducibility of sustained atrial fibrillation ( AF ) after pulmonary vein isolation ( PVI ) has been shown to be associated with a better clinical outcome . We evaluated the role of clinical variables that could predict noninducibility of sustained AF after PVI . METHODS AND RESULTS Data were collected prospect ively from 181 patients ( 153 male ; age 54 + /- 9 years ) referred for ablation of drug-refractory symptomatic paroxysmal AF ( duration Clinical variables were evaluated with regard to their ability of predicting noninducibility of sustained AF ( PVI . Univariate analysis was performed on all collected variables followed by multivariate analysis for variables showing a P value sustained AF was noninducible in 97 ( 54 % ) patients . The following clinical variables showed a significant difference between the groups : body weight , longest AF episode , duration of AF history , presence or absence of structural heart disease , left ventricular ( LV ) hypertrophy , prior cardioversion , left atrial ( LA ) parasternal , and longitudinal diameters and LV diameters . On multivariate analysis , three independent predictors of noninducibility were identified : a shorter duration of AF episodes ( AF LA longitudinal diameter absence of LV hypertrophy ( RR 0.15 ( 0.04 - 0.63 ) , P = 0.01 ) . CONCLUSIONS Shorter AF episodes , smaller LA longitudinal diameter , and absence of LV hypertrophy are independent predictors of noninducibility of sustained AF after PVI",
"BACKGROUND Data on the procedural safety of pulmonary vein radiofrequency catheter ablation for atrial fibrillation ( AF ) are as yet scant . OBJECTIVE The aims of the present study were to prospect ively evaluate the incidence of early complications of pulmonary vein ablation for AF in an unselected population of consecutive patients , and to identify possible predictors . METHODS From April 2005 to October 2006 , data from 1,011 consecutive patients who were undergoing radiofrequency catheter ablation for every type of AF in 10 Italian centers were collected . All complications occurring from the admission of the patient up to the 30th day were considered . RESULTS No procedure-related death was observed . Complications occurred in 40 patients ( 3.9 % ) : 12 ( 1.2 % ) had peripheral vascular complications , 8 ( 0.8 % ) had conservatively treated pericardial effusion , 6 ( 0.6 % ) had cardiac tamponade ( successfully drained ) , 5 ( 0.5 % ) had cerebral embolisms , 4 ( 0.4 % ) presented pulmonary vein stenosis > 50 % , and 5 ( 0.5 % ) presented other isolated adverse events . History of coronary artery disease ( odds ratio 5,603 , 95 % confidence interval 1,559 to 20,139 , P hemorrhagic complications . CONCLUSION Early complications of pulmonary vein catheter ablation seem to be fewer than in the early years of AF ablation , but still occur in 3.9 % of procedures",
"INTRODUCTION Circumferential pulmonary vein ablation ( CPVA ) with the endpoint of pulmonary vein ( PV ) isolation has been developed as an effective therapy for atrial fibrillation ( AF ) . This endpoint can be achieved either by closing gaps along circular lines or by segmental PV isolation inside the circular lines after creation of initial CPVA lesions . We investigated whether the clinical outcome depends on the PV isolation approach used during the first-time CPVA procedure . METHODS AND RESULTS One hundred consecutive patients ( 69 male ; age , 56.7 + /- 11.6 years ) who underwent first-time CPVA for treatment of symptomatic AF were enrolled . PV isolation was r and omly achieved either by CPVA alone ( aggressive CPVA [ A-CPVA ] group , n = 50 ) or by a combination of CPVA with segmental PV ostia ablation ( modified CPVA [ M-CPVA ] group , n = 50 ) . Recurrence of atrial tachyarrhythmias ( ATa ) within 3 months after the initial procedure occurred in 30 patients ( 60 % ) in the M-CPVA group and in only 15 patients ( 30 % ) in the A-CPVA group ( P ATa relapse after the first 3 months was detected in 21 patients ( 42 % ) in the M-CPVA group , compared with 9 patients ( 18 % ) in the A-CPVA group ( P = 0.01 ) . At 13 + /- 4 months , patients treated by the A-CPVA approach had greater freedom from ATa recurrence than patients who underwent M-CPVA ( P = 0.01 ) . The M-CPVA approach was the only independent predictor associated with procedural failure ( RR 0.318 ; 95 % CI 0.123 - 0.821 ; P = 0.02 ) . CONCLUSIONS When PV isolation is the endpoint of CPVA , the efficacy of the A-CPVA approach is better than that of M-CPVA",
"BACKGROUND A detailed appreciation of left atrial/pulmonary vein ( LA/PV ) anatomy may be important in improving the safety and success of catheter ablation ( CA ) for atrial fibrillation ( AF ) . OBJECTIVES The aim of this nonr and omized study was to determine the impact of computerized tomography ( CT ) image integration into a 3-dimensional ( 3D ) mapping system on the clinical outcome of patients undergoing CA for AF . METHODS Ninety-four patients ( age : 56 + /- 10 years ) with AF ( paroxysmal 46 , persistent 48 ) underwent wide encirclement of ipsilateral PV pairs using irrigated radiofrequency ablation with the endpoint of electrical isolation . Ablation was guided by 3D mapping alone ( electroanatomic 24 , noncontact 23 ) in 47 ( 3DM group ) patients and by CT image integration ( Cartomerge ) in 47 ( CT group ) . In persistent AF , a combination of linear ablation and targeted ablation of complex fractionated electrograms was also performed . RESULTS Successful PV electrical isolation did not differ between the two groups . A significant reduction in fluoroscopy times was demonstrated in the CT group ( 49 + /- 27 minutes vs 3DM group 62 + /- 26 minutes , P = 0.03 ) . Arrhythmia recurrence was reduced in the CT group ( 32 % vs 51 % in the 3DM group , P success on 7-day monitor off antiarrhythmic drugs was achieved in 60 % in the 3DM group when compared with 83 % in the CT group ( P fluoroscopy times , arrhythmia recurrence , and increased restoration of sinus rhythm . Improved visualization of complex LA geometries might improve the safety and success of CA for AF",
"Background — Obesity is a risk factor for atrial fibrillation and other cardiovascular conditions . Our objective was to determine whether catheter-based ablation effectively treated atrial fibrillation in obese patients . Methods and Results — Five hundred twenty-three consecutive patients with symptomatic , medication-refractory atrial fibrillation underwent catheter ablation . Patients were grouped by body mass index ( lean , . Outcome and quality of life were measured with a general health survey ( Medical Outcomes Study 36-item Short-Form General Health Survey [ SF-36 ] ) ; patients were assessed before ablation and at 3 and 12 months after the procedure . Two hundred twenty-eight study patients ( 44 % ) were overweight , and 201 ( 38 % ) were obese . Twelve months after curative ablation , 72 % of patients were free of atrial fibrillation without the use of antiarrhythmic agents ; 84 % were arrhythmia free when those receiving medication were included . Atrial fibrillation was eliminated in 75 % , 72 % , and 70 % of the lean , overweight , and obese patients , respectively , at 12 months ( P=0.41 , trend test ) . SF-36 scores were lower for patients with higher body mass index ( P baseline . SF-36 scores improved in every functional domain for all body mass index groups after ablation . The mean SF-36 total physical score increased from 59±20 at baseline to 77±19 in 12 months ( P ) . The total mental health score improved from 66±18 to 79±16 in 12 months ( P Conclusions — Catheter ablation of atrial fibrillation was effective in obese patients . Coexistence of atrial fibrillation and obesity indicated lower SF-36 scores , but the improvement in quality of life was consistent across all body mass index categories",
"OBJECTIVES The use of antiarrhythmic drugs after ablation is a controversial issue when evaluating the efficacy of atrial fibrillation ( AF ) ablation . This study compares in a prospect i ve and r and omized fashion the impact of an antiarrhythmic drug in preventing AF recurrence after AF ablation . METHODS From February 2004 to May 2005 , 107 consecutive patients ( mean age 57 + /- 10 years , 69 men ) , with paroxysmal ( 60 % ) or persistent ( 40 % ) drug refractory AF , were r and omly assigned to ablation alone ( Group A , 53 patients ) or combined with the best antiarrhythmic therapy , preferably amiodarone ( Group B , 54 patients ) . All patients underwent cavo-tricuspid and left inferior pulmonary vein (PV)-mitral isthmus ablation plus circumferential PV ablation , using a guided electro-anatomical approach . St and ard electrocardiograms ( ECG ) , and ambulatory and transtelephonic ECG monitoring were used to assess AF recurrences . Recurrences during the first month after ablation were excluded from this analysis . RESULTS At 12 months of follow-up , no significant difference was observed in the rates of AF recurrences between Group A ( 18/53 patients , 34 % ) and Group B ( 16/54 patients , 30 % ) . The percentage of patients with > /= 1 asymptomatic AF episode was higher in Group B than in Group A ( 10/16 patients , 63 % , vs 5/18 patients , 28 % , P = 0.04 ) . CONCLUSIONS Continuing antiarrhythmic drug therapy in patients who undergo catheter ablation for AF did not lower the rate of AF recurrences . Antiarrhythmic drugs increased the proportion of patients with asymptomatic AF episodes",
"AIMS Catheter ablation of atrial fibrillation ( AF ) is centred on pulmonary vein ( PV ) ablation with or without additional atrial substrate modification . These procedures may be prolonged with significant fluoroscopy exposure . This study evaluates a new non-fluoroscopic navigation system during ablation of AF . METHODS AND RESULTS Seventy-two patients undergoing catheter ablation of symptomatic drug refractory AF were prospect ively r and omized to ablation with ( n=35 ; study group ) or without ( n=37 ; control group ) non-fluoroscopic navigation . PV isolation was performed in all patients . In patients with persistent or inducible sustained AF after PV isolation linear ablation was performed by joining the superior PVs . PV isolation was achieved in all patients ; fluoroscopy ( 15.4+/-3.4 vs. 21.3+/-6.4 min ; P duration s were significantly reduced in the study group . Linear block was achieved in 37 of the 39 patients ; with a significant reduction in fluoroscopy ( 5.6+/-2.2 vs. 9.9+/-4.8 min ; P=0.003 ) and procedural ( 14.7+/-5.5 vs. 26.6+/-16.9 min ; P=0.007 ) duration s in the study group . After a follow-up of 6.9+/-2.9 months ( range 3 - 10 ) , 26 ( 74 % ) patients in the non-fluoroscopic navigation group and 29 ( 78 % ) patients in the control group were arrhythmia-free after the first procedure . CONCLUSION This prospect ively r and omized study demonstrates significant reduction of fluoroscopy exposure and procedural duration using supplementary non-fluoroscopic imaging system for AF ablation",
"OBJECTIVE To compare safety and efficacy of 8-mm versus cooled tip catheter in achieving electrical isolation ( EI ) of pulmonary veins ( PV ) for long-term control of atrial fibrillation ( AF ) . BACKGROUND There is paucity of studies comparing safety/efficacy of 8-mm and cooled tip catheters in patients undergoing AF ablation . METHODS AND RESULTS This was a r and omized and patient-blinded study . Subjects were followed by clinic visits ( at 6 weeks and 6 months ) and transtelephonic monitoring ( 3-week duration ) done around each visit . Primary endpoints were : ( 1 ) long-term AF control ( complete freedom and /or > 90 % reduction in AF burden on or off antiarrhythmic drugs at 6 months after a single ablation ) , and ( 2 ) occurrence of serious adverse events ( cardiac tamponade , stroke , LA-esophageal fistula , and /or death ) . Eighty-two patients ( age 56 + /- 9 years , 60 males , paroxysmal AF = 59 ) were r and omized ( 42 patients to 8-mm tip and 40 patients to cooled tip ) . EI of PVs was achieved in shorter time by the 8-mm tip as compared with cooled tip catheter ( 40 + /- 23 minutes vs 50 + /- 30 minutes ; P long-term AF control was not different between the two ( 32 patients [ 78 % ] vs 28 patients [ 70 % ] , respectively ; P = NS ) . One serious adverse event occurred in each group ( LA-esophageal fistula and stroke , respectively ) and no significant PV stenosis was observed in either . CONCLUSION EI of PVs using either 8-mm or cooled tip catheter results in long-term AF control in the majority after a single ablation procedure , with comparable efficacy and safety",
"AIMS In many laboratories , cooled-tip catheters have replaced 8 mm-tip catheters due to their theoretical advantage of achieving larger lesions and avoiding charring . However , direct comparisons between the catheters in the subset of atrial fibrillation ( AF ) ablation are scarce . The aim of this study was to compare the efficacy , safety , and lesion extension created by 8 mm-tip vs. cooled-tip catheter with different energy setting s for circumferential pulmonary vein ablation ( CPVA ) . METHODS AND RESULTS A series of 221 consecutive patients with symptomatic AF were included in the study . Circumferential pulmonary vein ablation was performed using an 8 mm-tip catheter ( 55 W , 50 degrees C ) in 90 patients ( Group 1 ) , a cooled-tip ( 30 W , 45 degrees C ) in 42 ( Group 2 ) , and a cooled-tip ( 40 W , 45 degrees C ) in 89 ( Group 3 ) . In a subgroup of 60 patients , troponin I ( TpnI ) , creatinine kinase , and myoglobin values were obtained before and at 12 and 24 h after ablation . At 1 year follow-up , the probability of being arrhythmia-free after a single procedure was 53 , 35 , and 55 % in patients from Groups 1 , 2 , and 3 , respectively . Ablation with a cooled-tip catheter at 30 W led to a higher recurrence rate ( P = 0.030 ) and was identified in Cox regression analysis as an independent predictor of AF recurrence ( HR , 1.713 ; 95 % CI , 1.02 - 2.90 ; P = 0.045 ) . There were no differences in intra-procedure complications ( 2.2 vs. 5.6 vs. 4.9 % , P = 0.542 ) . The myocardial lesion according to TpnI was smaller in Group 2 ( P = 0.02 ) . CONCLUSION The cooled-tip catheter at 30 W was less efficacious than both the 8 mm catheter and the cooled-tip with a 40 W power setting",
"BACKGROUND We question ed whether the empirical four pulmonary vein ( PV ) isolation ( EmPVI ) was necessary in patients with paroxysmal atrial fibrillation ( PAF ) triggered from clearly and reproducibly defined arrhythmogenic PVs . METHODS We compared the selective or ipsilateral isolation of the PVs triggering AF ( SePVI : n = 42 ) and EmPVI ( n = 35 ) in 77 patients ( males 80.5 % , mean age 53.0 + /- 13.4 years ) with PAF who underwent radiofrequency catheter ablation ( RFCA ) . Arrhythmogenic PVs were identified by the immediate recurrence of AF three consecutive times after cardioverting AF . RESULTS ( 1 ) The duration of the RF energy deliveries ( P total procedure time ( P AF recurrence rate was 38.1 % in the SePVI group and 25.7 % in the EmPVI group ( P = NS ) . ( 3 ) A redo-ablation was performed in 25 patients , and 81.0 % of the recurrent arrhythmogenic foci were found at a previously ablated PV or ipsilateral PV . ( 4 ) In 15.4 % of the SePVI and 20.0 % of the EmPVI procedures , AF recurred after 32.5 + /- 15.2 months of the redo-ablation . Subsequently , the AF-free rate for each group was 88.1 % ( 37/42 ) in the SePVI group and 91.4 % ( 32/35 ) in the EmPVI group ( P = NS ) . CONCLUSIONS In patients with clearly documented arrhythmogenic PVs , the SePVI of the PV triggering the AF or an ipsilateral PV had a comparable long-term success rate and shorter RF energy delivery and procedure times than the EmPVI",
"BACKGROUND Congestive heart failure and atrial fibrillation often coexist , and each adversely affects the other with respect to management and prognosis . We prospect ively evaluated the effect of catheter ablation for atrial fibrillation on left ventricular function in patients with heart failure . METHODS We studied 58 consecutive patients with congestive heart failure and a left ventricular ejection fraction of less than 45 percent who were undergoing catheter ablation for atrial fibrillation . We selected as controls 58 patients without congestive heart failure who were undergoing ablation for atrial fibrillation , matched according to age , sex , and classification of atrial fibrillation . We evaluated the patients ' left ventricular function and dimensions , symptom score , exercise capacity , and quality of life at baseline and at months 1 , 3 , 6 , and 12 . RESULTS After a mean ( + /-SD ) of 12+/-7 months , 78 percent of the patients with congestive heart failure and 84 percent of the controls remained in sinus rhythm ( P=0.34 ) ( 69 percent and 71 percent , respectively , were in sinus rhythm without the administration of antiarrhythmic drugs ) . The patients with congestive heart failure had significant improvement in left ventricular function ( increases in the ejection fraction and fractional shortening of 21+/-13 percent and 11+/-7 percent , respectively ; P left ventricular dimensions ( decreases in the diastolic and systolic diameters of 6+/-6 mm and 8+/-7 mm , respectively ; P=0.03 and P exercise capacity , symptoms , and quality of life . The ejection fraction improved significantly not only in patients without concurrent structural heart disease ( 24+/-10 percent , P catheter ablation without the use of drugs in patients with congestive heart failure and atrial fibrillation significantly improve cardiac function , symptoms , exercise capacity , and quality of life",
"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",
"UNLABELLED PV isolation at the antrum ( PVAI ) has improved safety and efficacy of ablation procedures for atrial fibrillation ( AF ) . AF triggers from the superior vena cava ( SVC ) may compromise the outcome of PVAI . PURPOSE We evaluated the ( 1 ) incidence of SVC triggers , ( 2 ) feasibility of empiric SVC electrical isolation ( SVCI ) as an adjunct to PVAI , and ( 3 ) SVCI safety . METHODS AND RESULTS Of 190 patients ( group I ) , 24 ( 12 % ) showed SVC triggers . Following PVAI , seven patients had AT originating from the SVC and three had AF . After SVCI , all 24 patients were arrhythmia-free 450 + /- 180 days post procedure . In the subsequent 217 patients ( group II ) , empirical SVCI was performed following PVAI . Sixty-six of all 407 patients ( 16 % ) experienced recurrence of AF . A repeat procedure in 25 of the 66 patients showed that five ( 20 % ) had AF recurrence initiated by SVC triggers , of whom four were among group I patients ( 4/190 ; 2 % ) and one was from group II ( 1/217 ; 0.4 % ) , ( P Transient diaphragmatic paralysis can be avoided by pacing at the lateral aspect of the SVC using high output ( 30 mA ) . There was no SVC stenosis on CT scans before or 3 months after the procedure . There was no sinus node injury . CONCLUSIONS The SVC harbors the majority of non-PV triggers of AF . SVCI is feasible , safe , and may be considered as an adjunctive strategy to PVAI for ablation of AF . The long-term favorable outcome of this hybrid approach remains to be evaluated in a larger series of patients",
"AIMS Circumferential pulmonary vein isolation ( CPVI ) is an established strategy for atrial fibrillation ( AF ) ablation . Superior vena cava ( SVC ) , by harbouring the majority of non-pulmonary vein ( PV ) foci , is the most common non-PV origin for AF . However , it is unknown whether CPVI combined with SVC isolation ( SVCI ) could improve clinical results and whether SVCI is technically safe and feasible . METHODS AND RESULTS A total of 106 cases ( 58 males , average age 66.0 + /- 8.8 years ) with paroxysmal AF were included for ablation . They were allocated r and omly to two groups : CPVI group ( n = 54 ) and CPVI + SVCI group ( n = 52 ) . All cases underwent the procedure successfully . Pulmonary vein isolation was achieved in all cases . The procedural time and fluoroscopic time were comparable between the two groups . The mean ablation time for SVC was 7.8 + /- 2.7 min . Superior vena cava isolation was obtained in 50/52 cases . In the remaining two cases , SVCI was not achieved because of obviating diaphragmatic nerve injury . During a mean follow-up of 4 + /- 2 months , 12 ( 22.2 % ) cases in the CPVI group and 10 ( 19.2 % ) cases in the CPVI + SVCI group had atrial tachyarrhythmias ( ATa ) recurrence ( P = 0.70 ) . Nine of 12 cases in the CPVI group and 8/10 cases in the CPVI + SVCI group underwent reablation ( P = 0.86 ) , and PV reconnection occurred in 7/9 cases in the CPVI group and in 8/8 cases in the CPVI + SVCI group . All PV reconnection was reisolated by gaps ablation . There was no SVC reconnection in the CPVI + SVCI group . In two cases without PV reconnection from the CPVI group , SVC-originated short run of atrial tachycardia was identified and eliminated by the SVCI . At the end of 12 months of follow-up , 50 cases ( 92.6 % ) in the CPVI group and 49 ( 94.2 % ) in the CPVI + SVC group were free of ATa recurrence ( P = 0.73 ) . CONCLUSION In our series of paroxysmal AF patients , empirically adding SVCI to CPVI did not significantly reduce the AF recurrence after ablation . Superior vena cava isolation may be useful , however , in selected patients in whom the SVC is identified as a trigger for AF . However , because of the preliminary property of the study and its relatively small sample size , the impact of SVCI on clinical results should be evaluated in a large series of patients",
"Different techniques have been proposed to treat atrial fibrillation ( AF ) by catheter ablation . This study compares a new three-dimensional ( 3D ) nonfluoroscopic navigation system with conventional fluoroscopy to guide pulmonary vein ( PV ) isolation . A total of 60 consecutive patients with paroxysmal or persistent AF were r and omly assigned to 3D-guided ablation ( group 1 , n = 30 ) , versus conventional fluoroscopy guidance ablation ( group 2 , n = 30 ) . Complete PV isolation was achieved in both groups . The mean duration of fluoroscopy exposure ( 22 + /- 8 vs 56 + /- 10 minutes ) , and radiofrequency delivery ( 5 + /- 1 vs 10 + /- 3 minutes ) were significantly shorter in group 1 than in group 2 , P mean procedural time in group 1 was longer ( 225 + /- 15 minutes ) than in group 2 ( 156 + /- 10 minutes , P AF recurrences compared to 3 patients ( 10 % ) in group 1 ( ns ) . The new nonfluoroscopic 3D system allows a high-resolution reconstruction of the left atrium and PVs . It significantly reduces the mean radiofrequency delivery and fluoroscopy times as opposed to ablation performed under fluoroscopy guidance",
"AIMS To compare clinical characteristics , procedure complexity , acute and long-term outcome of ' ablate and pace ' ( A&P ) with pulmonary vein isolation ( PVI ) in patients with drug-refractory atrial fibrillation ( AF ) . So far , only few small studies have compared the two procedures . METHODS AND RESULTS We analysed retrospectively a cohort of symptomatic consecutive patients with drug-refractory AF . Group 1 included 100 patients treated with A&P and Group 2 included 144 patients treated with PVI . Group 1 patients were older ( 74 + /- 8 vs. 56 + /- 9 years ; P AF ( 46 % vs. 65 % ; P Acute success was not statistically different ( 98 % vs. 92.3 % , P = ns ) . Group 1 patients had shorter procedure time and lower radiation exposure with respect to Group 2 patients ( 70 + /- 15 vs. 204 + /- 58 min , and 8 + /- 4 vs. 57 + /- 22 min ; P symptomatic AF , while 113 patients ( 79 % ) of Group 2 were in stable sinus rhythm ( P Persistent or permanent AF has been documented in 58 patients ( 58 % ) of Group 1 vs. 11 ( 8 % ) of Group 2 ( P A&P and PVI for drug-refractory AF showed significant differences in clinical profile ; ( ii ) A&P is a shorter and less complex procedure , but is associated with a higher rate of persistent AF ; ( iii ) symptomatic recurrences of paroxysmal AF were more frequent in PVI group . R and omized studies appear necessary to identify the best strategy in selected cases",
"BACKGROUND Both segmental ostial and circumferential extraostial pulmonary vein ( PV ) isolation have been proven effective in the treatment of atrial fibrillation ( AF ) . However , the recurrence of AF and PV conduction after the 2 ablation strategies has never been compared in a r and omized study . METHODS A total of 100 consecutive patients ( age 56 + /- 10 ; 71 men ) with symptomatic AF ( paroxysmal , 51 ; persistent , 49 ) were r and omized to segmental ostial ( n = 54 ) or circumferential extraostial ( n = 46 ) PV isolation . A circular catheter positioned at the ostium of each target PV guided the ostial PV isolation . Extraostial PV isolation was performed by encircling the paired left and right PVs , respectively , guided by an electroanatomic mapping system . RESULTS A total of 84 % of the patients had recurrent AF after the first PV isolation procedure , showing 72 % with AF and 12 % with organized left atrial tachycardia . In patients undergoing reablation , all but 2 patients had recurrence of left atrium PV conduction ( > 95 % ) . During a mean follow-up of 12 months without antiarrhythmic medication , 57 % of patients who underwent extraostial PV isolation were free of arrhythmia symptoms compared with 31 % of patients who underwent ostial PV isolation ( P success rate between the 2 ablation strategies was mainly seen in patients known with persistent AF ( 52 % and 15 % , respectively ; P = .02 ) as opposed to patients with paroxysmal AF ( 65 % and 46 % , respectively ; P = .26 ) . CONCLUSIONS Overall , the more proximal , extraostial PV isolation was found to be superior to ostial PV isolation , especially in patients known with persistent AF . A high recurrence rate of 84 % after a single complete PV isolation procedure was seen . At reablation , more than 95 % had recurrence of left atrium PV conduction regardless of the procedure used , supporting the idea that complete PV isolation seems essential to prevent arrhythmia recurrences",
"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",
"INTRODUCTION Pulmonary vein ( PV ) isolation for atrial fibrillation ( AF ) can be performed using a segmental ostial or a circumferential extra-ostial approach . The relative merits and potential limitations of each approach are currently debated . Here we report our early experience with each of these approaches , including their relative efficacy and safety . METHODS AND RESULTS Forty patients with drug-refractory AF underwent segmental ostial PV isolation and were compared to 40 consecutive patients who underwent PV isolation using a circumferential extra-ostial approach . The latter approach described here is novel in two aspects : ( 1 ) the endpoint for ablation was PV isolation and not only delay in left atrial to PV conduction time , and ( 2 ) isolation of the right and left PVs was achieved by a single encirclement of ipsilateral veins . At follow-up , 60 % of the patients in the segmental group were free of AF compared to 75 % of the patients in the circumferential group . There was one thromboembolic cerebrovascular complication during the ablation procedure in each group . CONCLUSION PV isolation using a circumferential extra-ostial approach , where the ipsilateral PVs are isolated together by one encircling line of block using electroanatomic mapping , is a technically feasible procedure . This approach is at least as effective and safe as the more established segmental ostial approach for AF ablation",
"AIMS Circumferential pulmonary vein isolation ( CPVI ) has been reported to account for 30 % of atrial fibrillation ( AF ) recurrence after initial ablation , and pulmonary vein ( PV ) re-connection accounts for about 80 % of AF recurrence . There is no information in the literature whether early identification and treatment of acute PV conduction recovery during initial ablation has an impact on subsequent clinical results . The objective is to investigate the prevalence of acute PV conduction recovery during the observation time after PV isolation for paroxysmal AF , and to evaluate the impact of re-isolation treatment on clinical results . METHODS AND RESULTS Ninety cases with paroxysmal AF ( 51 males , mean age of 56.4 + /- 12.3 years ) were r and omized to 3 groups to undergo CPVI . In Group A , there was no observation time post-ablation . In Group B , there was 30 min of observation time post-ablation . In Group C , there was 60 min of observation time post-ablation . All PV re-conduction was re-isolated at the end of the observation time . ECG and Holter monitors were used to evaluate the clinical effectiveness of ablation . All cases underwent the procedure successfully . The mean procedural time in Group A was significantly shorter than in Group B and Group C , but there was no significant difference on fluoroscopic time and PV isolation time among the three groups . In Group B , PV re-conduction occurred in 8 cases ( 25 % ) at 30 min post-isolation , in 10 cases ( 31.2 % ) at 60 min post-isolation for left PVs , and in 6 cases ( 18.8 % ) at 30 min post-isolation for right PVs . In Group C , PV re-conduction for left PVs occurred in 9 cases ( 30 % ) at 30 min post-isolation and in 11 cases ( 36.7 % ) at 60 min post-isolation ; for right PVs this occurred in 7 cases ( 23.3 % ) at 30 min post-isolation and in 8 cases ( 26.7 % ) at 60 min post-isolation . During a mean follow-up of 6.7 + /- 2.3 months , 17 cases ( 60.7 % ) in Group A , 27 cases ( 84.3 % ) in Group B , and 26 cases ( 86.7 % ) in Group C had no recurrence of atrial tachyarrhythmias , P = 0.04 . CONCLUSION The prevalence of acute PV conduction recovery was about 30 % after PV isolation , which mostly occurred within 30 min after initial isolation . Re-isolation of recovered PV conduction contributed to the improvement in the success rate of ablation for paroxysmal AF",
"Background and objective Little is known about the outcome of catheter ablation of atrial fibrillation ( AF ) in patients with diabetes mellitus ( DM ) . We investigated the safety and efficacy of catheter ablation of AF in patients with DM . Material s and methods Thirty one patients with DM from a group of 263 consecutive patients undergoing a first-time catheter ablation of AF procedure were enrolled in a prospect i ve study . The ablation protocol ( guided by CARTO system ) consisted in two continuous circular lesions around ipsilateral pulmonary veins . Results The following clinical characteristics differed between DM and no-DM patients : age ( 62.0 ± 10.8 vs. 56.1 ± 10.6 years , P = 0.004 ) , longer AF history ( 9.6 ± 9.3 vs. 6.7 ± 6.3 years , P = 0.024 ) , significantly larger left atrium size ( 41.1 ± 7.8 vs. 38.3 ± 5.8 mm , P = 0.021 ) , hypertension ( 58.1 vs. 35.8 % , P = 0.018 ) and structural heart disease ( 67.7 vs. 43.5 % , P = 0.011 ) . Despite a similar AF recurrence rate in DM and no-DM patients ( 32.3 vs. 22.4 % , P = 0.240 ) , the ablation procedure was complicated in 28 patients ( 11 hematomas , three cardiac tamponades and three strokes ) and the incidence of complications was significantly higher in DM than in no-DM patients ( 29.0 vs. 8.2 % , respectively , P = 0.002 ) . Multivariate analysis showed that DM was an independent risk factor for complications occurrence ( odd ratio 5.936 , 95 % confidence interval 2.059 to 17.112 , P = 0.001 ) . Conclusions First catheter ablation of AF procedure in DM patients was equally efficacious than in no-DM patients . However , DM patients had a higher incidence of complications , mostly thrombotic or hemorrhagic"
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41173516-06ff-11f0-808a-c43d1ab1c353
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The aim of this systematic review was to compare the clinical performance and failure modes of teeth restored with intra-radicular retainers . A search was performed on PubMed / Medline , Central and Clinical Trials data bases for r and omized clinical trials comparing clinical behavior and failures of at least two types of retainers . From 341 detected papers , 16 were selected for full-text analysis , of which 9 met the eligibility criteria . A manual search added 2 more studies , totalizing 11 studies that were included in this review . Evaluated retainers were fiber ( prefabricated and customized ) and metal ( prefabricated and cast ) posts , and follow-up ranged from 6 months to 10 years . Most studies showed good clinical behavior for evaluated intra-radicular retainers . Reported survival rates varied from 71 to 100 % for fiber posts and 50 to 97.1 % for metal posts . Studies found no difference in the survival among different metal posts and most studies found no difference between fiber and metal posts . Two studies also showed that remaining dentine height , number of walls and ferrule increased the longevity of the restored teeth . Failures of fiber posts were mainly due to post loss of retention , while metal post failures were mostly related to root fracture , post fracture and crown and /or post loss of retention . In conclusion , metal and fiber posts present similar clinical behavior at short to medium term follow-up . Remaining dental structure and ferrule increase the survival of restored pulpless teeth . Studies with longer follow-up are needed
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"This study reports a prospect i ve clinical trial comparing a carbon fibre reinforced carbon ( CFRC ) endodontic post with a conventional prefabricated post . Twenty-seven single rooted maxillary anterior teeth in 18 patients ( nine males and nine females ; age range 18 - 60 years ) were restored either with a CFRC post or a wrought precious alloy control . Cast type III gold alloy cores were used in conjunction with both post groups . The CRFC posts ( n = 16 ) were cemented with a composite luting agent and the conventional posts ( control ) were cemented with zinc phosphate . Four failures were recorded in the CFRC post group at 24 , 29 , 56 and 87 months , compared with one failure in the control group at 84 months . These results suggest that post-retained crowns utilizing a CFRC material and a composite resin luting agent do not perform as well as conventional wrought precious alloy posts",
"STATEMENT OF PROBLEM It is unclear which post and core system performs best when bonded to severely compromised endodontically treated teeth . PURPOSE The purpose of this study was to investigate the fracture resistance and mode of failure of severely compromised teeth restored with 3 different adhesively bonded post and core systems . MATERIAL AND METHODS Thirty extracted endodontically treated maxillary anterior teeth were r and omly divided into 3 groups , CPC , gold cast post and core ; TPC , titanium prefabricated post/composite resin core ; and FPC , quartz fiber reinforced post/composite resin core . All posts were adhesively cemented . All cores resembled a central incisor preparation with no remaining tooth structure above the finish line . Cast gold crowns were fabricated and cemented adhesively . The specimens were aged with thermocycling and cyclic loading . Two specimens per group were r and omly selected for micro-computed tomographic imaging before and after aging . Failure was induced with a universal testing machine . The mode of failure was characterized by the interface separation . Data were analyzed with 1-way ANOVA ( α=.05 ) followed by post hoc tests ( Bonferroni ) . RESULTS A statistically significant difference was found among the 3 groups ( P=.002 ) . CPC was significantly different than TPC ( P=.008 ) or FPC ( P=.003 ) . The primary mode of failure for CPC and TPC was root fracture , and for FPC post debonding . CONCLUSIONS Severely compromised endodontically treated teeth restored with bonded gold cast post and cores showed significantly higher fracture resistance ",
"Glass fiber-reinforced endodontic posts are considered to have favorable mechanical properties for the reconstruction of endodontically treated teeth . The aim of the present investigation was to evaluate the survival of two tapered and one parallel-sided glass fiber-reinforced endodontic post systems in teeth with different stages of hard tissue loss and to identify risk factors for restoration failure . One-hundred and forty-nine glass fiber-reinforced endodontic posts in 122 patients were followed-up for 5 - 56 months [ mean + /- st and ard deviation ( SD ) : 39 + /- 11 months ] . Glass fiber-reinforced endodontic posts were adhesively luted and the core was built with a composite resin . Cox proportional hazards models were used to evaluate the association of clinical variables and failure rate . Higher failure rates were found for restorations of anterior teeth compared with posterior teeth [ Hazard-Ratios ( HR ) : 3.1 ; 95 % confidence interval ( CI ) : 1.3 - 7.4 ] , for restorations in teeth with no proximal contacts compared with at least one proximal contact ( HR : 3.0 ; 95 % CI : 1.0 - 9.0 ) , and for teeth restored with single crowns compared with fixed bridges ( HR : 4.3 ; 95 % CI : 1.1 - 16.2 ) . Tooth type , type of final restoration and the presence of adjacent teeth were found to be significant predictors of failure rates in endodontically treated teeth restored with glass fiber-reinforced endodontic posts",
"AIM To assess survival rates and complications of root-filled teeth restored with or without post- and -core systems over a mean observation period of > or=4 years . METHODOLOGY A total of 325 single- and multirooted teeth in 183 subjects treated in a private practice were root filled and restored with either a cast post- and -core or with a prefabricated titanium post and composite core . Root-filled teeth without post-retained restorations served as controls . The restored teeth served as abutments for single unit metal-ceramic or composite crowns or fixed bridges . Teeth supporting cantilever bridges , overdentures or telescopic crowns were excluded . RESULTS Seventeen teeth in 17 subjects were lost to follow-up ( 17/325 : 5.2 % ) . The mean observation period was 5.2 + /- 1.8 ( SD ) years for restorations with titanium posts , 6.2 + /- 2.0 ( SD ) years for cast post- and -cores and 4.4 + /- 1.7 ( SD ) years for teeth without posts . Overall , 54 % of build-ups included the incorporation of a titanium post and 26.5 % the cementation of a cast post- and -core . The remaining 19.5 % of the teeth were restored without intraradicular retention . The adjusted 5-year tooth survival rate amounted to 92.5 % for teeth restored with titanium posts , to 97.1 % for teeth restored with cast post- and -cores and to 94.3 % for teeth without post restorations , respectively . The most frequent complications included root fracture ( 6.2 % ) , recurrent caries ( 1.9 % ) , post-treatment periradicular disease ( 1.6 % ) and loss of retention ( 1.3 % ) . CONCLUSION Provided that high- quality root canal treatment and restorative protocol s are implemented , high survival and low complication rates of single- and multirooted root-filled teeth used as abutments for fixed restorations can be expected after a mean observation period of > or=4 years",
"PURPOSE This study prospect ively evaluated the clinical performance of three types of translucent posts over a follow-up period of between 2 and 3 years . MATERIAL S AND METHODS Selected were 225 patients with one premolar in need of endodontic treatment , followed by restoration with a fiber post and porcelain crown . The sample was r and omly divided into three groups of 75 patients each . The same type of post was used in all patients within a group : group 1 = Aesthetic Plus ; group 2 = DT ; and group 3 = FRC Postec . For bonding the post , a light-curing adhesive ( One-Step ) and a dual-curing resin cement ( Duo-Link ) were applied in group 1 and 2 roots , whereas self-curing material s ( Excite DSC as adhesive and MultiLink as resin cement ) were used in group 3 . After 6 , 12 , and 24 months , patients were recalled , and a clinical and radiographic examination was performed . For some patients , 30-month follow-up data were also collected . RESULTS Debonding of the post occurrred in eight cases ( 3.5 % ) ; in another six cases , a recurrence of the periapical lesion was reported . CONCLUSION The statistical analysis did not reveal any significant difference in the survival rate of the tested posts , suggesting that all are equally and sufficiently reliable for clinical use",
"PURPOSE In the present prospect i ve study , four different post- and -core systems were evaluated over a period of up to 10 years . MATERIAL S AND METHODS Fifty endodontically treated teeth in 31 patients were r and omized to one of four groups for post- and -core placement : Group 1 received conventional tapered cast posts and cores ( n = 14 ) ; group 2 received ParaPost system prefabricated gold posts with cast cores ( n = 13 ) ; group 3 received ParaPost system cast posts and cores ( n = 13 ) ; and group 4 received Radix-Anchor posts ( n = 10 ) . Clinical and radiologic evaluations were made . RESULTS One post and core in group 2 was functioning well 58 months after placement when the patient died . No posts and cores in groups 1 or 2 had been lost or had any complications , one in group 3 had been lost because of a root fracture after 108 months , and two in group 4 had been lost after 54 and 88 months , respectively , because of loss of retention . The final treatment result for 46 of the 49 remaining posts ( 30 patients ) was successful . The overall failure rate was 6 % . There were no statistically significant differences between the four groups . CONCLUSION If recommended procedures are strictly followed , posts and cores can serve as abutments for fixed single crowns with satisfactory long-term results",
"PURPOSE To determine , in a 3-year clinical trial , whether tooth type and ferrule significantly affect the survival of pulpless teeth restored with fiber posts . METHODS A sample of 87 teeth in 87 patients ( 32 men and 55 women , age ranged from 23 to 78 ) were restored using Snowpost : 34 incisors , 12 canines , 25 premolars and 16 molars . The posts were cemented with RelyXUnicem and the core was made with a resin composite ( Dentocore Automix ) . Every tooth was covered with a metal-ceramic or all ceramic crown . Two experimental groups , according to the presence or absence of ferrule , were defined : A ) 45 teeth with ferrule ( > 2 mm height ) ; and B ) 42 teeth without ferrule ( failed ( 16.1 % ) . The failure modes were caries ( n=4 ) , post fracture ( n=4 ) , root fracture ( n=2 ) , and marginal gap , post cement failure , crown cement failure , and periapical lesion ( n= 1 respectively ) . In Group A the failure observed was 6.67 % and in Group B it was 26.20 % . The log-rank test showed statistically significant differences between both groups . According to the type of tooth , the incisors were the teeth with the highest failure rate ( 73.52 % ) , but Chi-square test showed no statistically significant differences among the four tooth types , perhaps because of the low number of the sample",
"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",
"OBJECTIVE To assess the survival rate of two different post systems after 5 years of service with a prospect i ve r and omized controlled trial . METHOD AND MATERIAL S One hundred patients in need of a post were studied . Half of the patients received long glass fiber-reinforced posts , while the other half received long metal screw posts . The posts were assigned r and omly . After at least 5 years ( mean , 61.37 months ) , follow-ups were established . When a complication occurred prior to this recall , the type and time of the complication was documented . Statistical analysis was performed using the log-rank test and Kaplan-Meier analysis . Additionally , a Cox regression was performed to analyze risk factors . RESULTS The survival rate of fiber-reinforced posts was 71.8 % . In the metal screw post group , the survival rate was significantly lower , 50.0 % ( log-rank test , P = .026 ) . Metal posts result ed more often in more unfavorable complications ( eg , root fractures ) ; consequently , more teeth ( n = 17 ) had to be extracted . The Cox regression identified the following risk factors : position of the tooth ( anterior vs posterior teeth ) , degree of coronal tooth destruction , and the post system ( fiber-reinforced post vs metal screw post ) . Fiber-reinforced restorations loosened in several patients ; in some of these cases ( n = 6 ) , patients did not notice this , leading to the extraction of teeth . CONCLUSION Long metal screw posts should be used with great care in endodontically treated teeth . Besides the selection of the post system , other factors influence the survival of the restoration",
"PURPOSE The aim of this study was to compare the 5-year outcomes of glass fiber composite with cast posts and cores for the restoration of endodontically treated teeth . MATERIAL S AND METHODS A total of 143 patients in need of 203 full ceramic restorations on endodontically treated teeth were included . After primary stratification based on the need for post or no post , teeth were r and omly allotted to test group 1 ( prefabricated glass fiber posts ) , 2 ( custom-made glass fiber posts ) , or 3 ( composite cores without posts ) . The control group was treated with gold alloy-based wrought posts and cast cores . Success ( original present ) and survival ( present after intervention ) probability lifetime curves , corrected for clustering , were drawn over the entire data set . RESULTS The mean follow-up time was 5.8 years ( range : 0.5 to 7.2 years ) . At 5 years , the success and survival probabilities were 85.2 % and 91.5 % , respectively . Lifetime curves did not show any significant differences between the test and control groups for success ( P = .85 ) or survival ( P = .57 ) . Moreover , no significant differences for success or survival could be found among the four groups ( the three test groups and the control group ) . CONCLUSION After 5 years of follow-up , cast gold and composite post- and -core systems on teeth with ceramic full restorations provided with a ferrule performed equally well",
"Clinical evidence is lacking regarding the influence of the amount of residual coronal dentin and of post placement on the failure risk of endodontically compromised teeth . The aim of this prospect i ve clinical trial was to assess whether these factors significantly affect the two-year survival of restored pulpless premolars . A sample of 210 individuals provided six experimental groups of 40 premolars in need of endodontic treatment . Groups were defined based on the amount of dentin left at the coronal level . Within each group , in half of the teeth selected at r and om , a fiber post was inserted inside the root canal , whereas in the remaining half of the premolars , no post was placed . All teeth were covered with a crown . The Cox regression analysis revealed that post placement result ed in a significant reduction of failure risk ( p Failure risk was increased for teeth under the “ no ferrule ” ( p = 0.001 ) and “ ferrule effect ” conditions ( p = 0.004 )",
"PURPOSE The aim of this prospect i ve r and omized controlled trial was to evaluate the influence of clinical baseline characteristics on the survival of 2 post systems . MATERIAL S AND METHODS One hundred patients needing a post were included . Half the patients received a glass fiber-reinforced post ( FRP ) , and the other half received metal screw posts ( MSP ) . The posts were assigned r and omly . In addition to demographic data , the following parameters were recorded : type of tooth ( incisor/canine versus molar/premolar ) , length of the post in relation to root length ( percentage ) , extent of coronal tooth destruction ( percentage ) , ferrule height ( in millimeters ) , type of restoration ( fixed or removable partial denture ) , and presence of antagonistic contacts ( yes/no ) . After at least 1 year ( mean : 13.84 months ) , the patients were recalled . Statistical analysis was performed using the log-rank test and Cox regression analysis . RESULTS The survival rate of FRPs was 93.5 % . In the MSP group , the survival rate was significantly lower ( 75.6 % ; log-rank test , P = .049 ) . Additionally , the metal posts were associated with more unfavorable complications , for example , root fracture . The type of the tooth and the degree of coronal tooth destruction influenced the survival of MSPs , whereas no influence of these variables could be seen for FRPs . CONCLUSION FRPs are superior to MSPs with respect to short-term clinical performance . Especially for MSPs , clinical survival depends on several variables",
"PURPOSE To assess whether the amount of residual coronal dentin and the placement of a prefabricated ( DT Light Post ) ( LP ) or a customized fiber post ( Ever Stick Post ) ( ES ) have a significant influence on the 3-year survival of endodontically treated premolars . METHODS A sample of 345 patients provided six groups of 60 premolars in need of endodontic treatment . Groups were defined based on the amount of dentin left at the coronal level after endodontic treatment and before abutment build-up . Within each group teeth were r and omly divided into three subgroups ( n = 20 ) . In Subgroup A , no root canal retention was provided for the coronal restoration . In Subgroups B and C , LP and ES , respectively , were placed inside the root canal . All the teeth were finally restored with a single unit metal-ceramic crown . RESULTS Data were not affected by any loss to follow-up . The overall 36-month survival rate of crowned endodontically treated premolars was 76.7 % . The lowest survival rate was recorded for teeth restored without any root canal retention ( 62.5 % ) . Teeth restored with LP had a survival rate higher ( 90.9 % ) than those restored with ES ( 76.7 % ) . The Cox regression analysis showed that the presence of root canal retention was a significant factor for survival ( P decrease in failure risk was higher in teeth restored with LP ( HR = 0.1 ; 95 % CI for HR = 0.09 to 0.34 ; P lower failure risk than teeth deprived even of the ferrule effect . Similar failure risks existed for teeth missing all the coronal walls regardless of the presence or absence of a ferrule effect ( P > 0.05 ) . Interaction terms were not significant ( P > 0.05 ) . Post placement and the amount of residual coronal dentin affected the 3-year survival of endodontically treated premolars",
"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 )"
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41173552-06ff-11f0-808a-c43d1ab1c353
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Background There is a strong tradition of performing a clinical examination of low back pain ( LBP ) patients and this is generally recommended in guidelines . However , establishing a pathoanatomic diagnosis does not seem possible in most LBP patients and clinical tests may potentially be more relevant as prognostic factors . The aim of this review of the literature was to systematic ally assess the association between low-tech clinical tests commonly used in adult patients with acute , recurrent or chronic LBP and short- and long-term outcome . Methods MEDLINE , Embase , and MANTIS were search ed from inception to June 2012 . Prospect i ve clinical studies of adult patients with LBP with or without leg pain and /or signs of nerve root involvement or spinal stenosis , receiving non-surgical or no treatment , which investigated the association between low-tech clinical tests and outcome were included . Study selection , data extraction and appraisal of study quality were performed independently by two review ers . Results A total of 5,332 citations were retrieved and screened for eligibility , 342 articles were assessed as full text and 49 met the inclusion criteria . Due to clinical and statistical heterogeneity , qualitative synthesis rather than meta- analysis was performed . Associations between clinical tests and outcomes were often inconsistent between studies . In more than one third of the tests , there was no evidence of the tests being associated with outcome . Only two clinical tests demonstrated a consistent association with at least one of the outcomes : central ization and non-organic signs . Conclusions For most clinical tests in LBP there is not consistent evidence for an association with outcome . Central ization and non-organic signs are exceptions from that . None of the other clinical tests have been investigated in confirmatory studies and study quality is generally low . There is a need for hypothesis testing studies design ed specifically to investigate the prognostic value of the clinical tests , and a need for st and ardization of the performance and interpretation of tests
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"STUDY DESIGN Prospect i ve inception cohort study . OBJECTIVE To develop a prognostic model that predicts time receiving workers ' compensation benefits for low back pain cl aim ants . SUMMARY OF BACKGROUND DATA As the cost and difficulty of managing low back pain escalate , any predictor of outcome is advantageous . METHODS To obtain the outcome and predictor variables , patient data from two separate data bases were linked : a clinical data base and an administrative ( Ontario workers ' compensation ) data base . Cl aim ants injured between January 1 and December 31 , 1994 , were included and observed for 1 year from the date of accident . The outcome variable was cumulative number of calendar days receiving benefits . RESULTS Multivariable Cox proportional hazards regression ( forward stepwise ) showed eight significant predictors ; five were associated with increased time receiving benefits compared with their reference groups : 1 ) working in the construction industry , 2 ) older age , 3 ) lag time from injury to treatment , 4 ) pain referred into the leg , and 5 ) three or more positive Waddell nonorganic signs . Three predictors were associated with reduced time receiving benefits : 1 ) higher values of question naire score , 2 ) intermittent pain , and 3 ) a previous episode of back pain . A predictive score was calculated to categorize cl aim ants as at high or low risk for chronicity . When an arbitrary cutoff point was set at the 75th percentile of predictive score , negative predictive value was 94 % . CONCLUSION This research identified eight factors for time receiving workers ' compensation benefits among cl aim ants with low back pain . This model discriminates between high- and low-risk cl aim ants . Few low-risk cl aim ants continued to receive benefits for more than 3 months",
"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 prospect i ve clinical trial was conducted that involved six groups of patients with chronic low back pain selected from a large cohort ( N = 816 ) . Objectives . To correlate pretreatment baseline variables with outcome parameters after treatment in a functional restoration program or in control programs , to identify possible factors predictive of the need for functional restoration . Summary of Background Data . Since the functional restoration program was first described , research has focused on identifying patients who will or will not benefit from such a program . The value of previous studies is limited , however , because predictive factors from a control group were not \" subtracted . \" Methods . Eight hundred sixteen patients with chronic low back disability were included . All had a structured medical examination , including various physical tests before participation in either a functional restoration program ( n = 621 ) or shorter \" control \" outpatient programs ( n = 144 ) . A smaller group of the cohort ( n = 51 ) had no treatment and served as a pure control group . Six groups were selected from the cohort : Three underwent an identical functional restoration program and three underwent different outpatient control programs . Several baseline demographic , physical , and socioeconomic variables were correlated to 1‐year outcome parameters . Results . Age , days of sick leave , connection to the work force , and back pain intensity , were significantly correlated to success 1 year after entry into the study in all groups , no matter what kind of treatment was administered . Back muscle endurance , sports activity , activity of daily living scores , and vibrations were of importance in some outcome parameters for success after functional restoration . Smoking was positively correlated to disability pension . Days of sick leave and , in functional restoration , ability to work were the only factors that were correlative with statistics for people who withdrew . Conclusions . Different factors can be identified as predictive of outcome in a functional restoration program , but most of these factors were also shown to predict success for shorter control outpatient programs or of no treatment",
"Many manual therapists assess and treat spinal stiffness of people with low back pain . The objectives of this study were to investigate : ( i ) whether spinal stiffness changes after treatment ; ( ii ) the relationship between pre-treatment spinal stiffness and change in stiffness with treatment ; ( iii ) the relationship between spinal stiffness , pain , disability and global perceived effect of treatment ; ( iv ) whether spinal stiffness predicts outcome of treatment or response to treatment in chronic low back pain patients . One hundred and ninety-one subjects with chronic low back pain were r and omly allocated to groups that received either spinal manipulative therapy , motor control exercise , or a general exercise program . Spinal stiffness was assessed before and after intervention . All three groups showed a significant decrease in stiffness following treatment ( p No difference between groups was observed . There was a significant negative correlation between pre-treatment stiffness and change in stiffness ( r=-0.61 ; p change in stiffness and change in global perceived effect of treatment , and a significant but weak correlation between change in stiffness and change in function for subjects in the spinal manipulative therapy group ( r=-0.28 ; p=0.02 ) . No significant association was observed between initial stiffness score and any of the final outcome measures following treatment . Initial stiffness did not predict response to any treatment . In conclusion , spinal stiffness decreases over the course of an episode of treatment , more so in those with the stiffest spines , but the decrease is not dependent on treatment and is not generally related to outcome",
"Study Design Two-hundred-forty-three patients with chronic low back pain were studied in a prospect i ve comparative survey to determine whether the “ central ization phenomenon ” was associated with outcome after an interdisciplinary work-hardning program . Objective The hypothesis was that patients who demonstrated central ization during initial mechanical assessment would have better outcomes than non central izers . Summary of Background Data Overall subjects had decreased pain intensity ratings ( mean 10 % ) , increased lifting ability ( 6–8 kg ) , and a 59.2 % return-to-work rate at a mean of 9.7 months follow-up . Methods . Patients were classified as either central izers or non central izer , based on results of their initial assessment , changes in pain ratings , one-time maximal weights lifted , Oswestry scores , and returen-to-work status were compared between groups . Results The central izers reported significant decreases in their maximum pain ratings ( central izers , 16 % non central izers , 6 % ) and had higher return-to-work rate ( central izers , 68 % ; non central izers , 52 % ) than the non central izers . Conclusion . Centrelization can help identify subgroups within the population with chronic low back pain and could be a useful goal setting and case management toll in the rehabilitation of low back pain",
"OBJECTIVE To develop a clinical prediction rule to predict treatment response to a stabilization exercise program for patients with low back pain ( LBP ) . DESIGN A prospect i ve , cohort study of patients with nonradicular LBP referred to physical therapy ( PT ) . SETTING Outpatient PT clinics . PARTICIPANTS Fifty-four patients with nonradicular LBP . INTERVENTION A st and ardized stabilization exercise program . MAIN OUTCOME MEASURE Treatment response ( success or failure ) was categorized based on changes in the Oswestry Disability Question naire scores after 8 weeks . RESULTS Eighteen subjects were categorized as treatment successes , 15 as treatment failures , and 21 as somewhat improved . After using regression analyses to determine the association between st and ardized examination variables and treatment response status , preliminary clinical prediction rules were developed for predicting success ( positive likelihood ratio [ LR ] , 4.0 ) and failure ( negative LR , .18 ) . The most important variables were age , straight-leg raise , prone instability test , aberrant motions , lumbar hypermobility , and fear-avoidance beliefs . CONCLUSIONS It appears that the response to a stabilization exercise program in patients with LBP can be predicted from variables collected from the clinical examination . The prediction rules could be used to determine whether patients with LBP are likely to benefit from stabilization exercises",
"Aim To determine the frequency of different patterns of central ization and their association with outcomes and MRI findings in patients experiencing sciatica . Methods A prospect i ve longitudinal cohort study of 176 patients with radicular pain below the knee , who all had an MDT clinical assessment . Based on their pain response , patients were divided into five groups : abolition central ization , reduction central ization , unstable central ization , peripheralization , and “ no effect ” . Patients had an MRI . Results Overall , 84.8 % of patients reported experiencing central ization , 7.3 % peripheralized and 7.9 % reported “ no effect ” . The median reduction in RMQ scores across all the three central ization groups was 9.5 points at 3 months , and 12.0 points at 12 months . The peripheralization group improved similarly . The ‘ no effect ’ group improved significantly lower ( p leg pain , the “ no effect ” group demonstrated a less favorable outcome ( p pain responses and the type of disc lesion . Conclusion In patients with sciatica , central ization was common and associated with improvement in activity limitation and leg pain . Central ization was very common in ruptured disc therefore the study does not support the theory , that central ization only occurs if the intra-discal hydrostatic mechanism is functional",
"BACKGROUND The prognostic value of the clinical findings elicited in the patient presenting with sciatica is unknown . AIM To investigate whether history and physical examination findings can predict outcome . DESIGN OF STUDY Prospect i ve study of prognostic factors . SETTING A sample of primary care patients with sciatica . METHOD Short-term favourable outcome was registered as improvement perceived by the patient after two weeks . Long-term failure was defined as eventual surgery or lack of improvement after three months . RESULTS The signs and symptoms that most consistently predicted an unfavourable outcome were : a disease duration of more than 30 days ; increased pain on sitting ; and more pain on coughing , sneezing or straining . The straight leg raising test and , to a lesser degree the reversed straight leg raising test , were the most consistent examination findings associated with poor outcome . Chances of short-term improvement were also related to the body weight relative to the length . CONCLUSION The predictors in this study can indicate the prognosis of patients with sciatica at an early stage . Knowledge of these prognostic factors may help to fine tune treatment decisions and improve patient selection in trials of conservative therapy strategies",
"Study Design . The study included 90 disabled patients with chronic low back pain recruited from a pain clinic who were admitted to an 8-week program of functional restoration and behavioral support . Initial evaluations included a medical examination , rating of the physical impairment , a personal interview , a visual analogue scale to record pain intensity , an assessment of limitations for daily activities , a pain disability index , a depression and psychovegetative scale , and a scale to evaluate general living st and ards . The physical assessment included different flexibility measurements , measurement of power and endurance through st and ardized exercises , and measurements of isokinetic trunk and lifting strength and general endurance . The measurements were repeated at the end of the 8-week program and thereafter at intervals of 6 and 12 months . Final analyses were carried out on 82 patients . Objectives . To determine whether objective or subjective signs most influence the outcome of rehabilitation . Summary of Background Data . In recent years , several studies have shown that active and intensive multimodal treatment of chronic low back pain is successful . Until now there has been lack of information about which patients will respond to the therapy and what is the most effective part of treatment . Methods . Prognostic factors ( return to work , pain intensity , self- assessment of treatment success by patients ) were tested by study ing variance and regression analyses for their ability to predict treatment outcome . Results . Certain factors were identified that had a significant impact on determining the probability of a patient 's return to work and the reduction of pain intensity . These factors included self-evaluation for predicting a return to work , the length of absence from work , application for pension , and a decrease in disability after treatment . Overall satisfaction with treatment was best determined by the number of medical consultations before treatment , the extent of disability , previous measures taken for coping with the disease , and reduction of disability during treatment . Medical background , medical diagnosis , and physical impairment had no predictive value . Physical variables ( i.e. , mobility , strength , endurance , and physical performance ) also demonstrated only limited predictive value . Conclusion . This study has demonstrated that the most important variable in determining a successful treatment of chronic low back pain is the reduction of subjective feelings of disability in patients",
"STUDY DESIGN A cohort of 100 patients with symptomatic lumbar spinal stenosis , characterized in a previous article , were given surgical or conservative treatment and followed for 10 years . OBJECTIVES To identify the short- and long-term results after surgical and conservative treatment , and to determine whether clinical or radiologic predictors for the treatment result can be defined . SUMMARY OF BACKGROUND DATA Surgical decompression has been considered the rational treatment . However , clinical experience indicates that many patients do well with conservative treatment . METHODS In this study , 19 patients with severe symptoms were selected for surgical treatment and 50 patients with moderate symptoms for conservative treatment , whereas 31 patients were r and omized between the conservative ( n = 18 ) and surgical ( n = 13 ) treatment groups . Pain was decisive for the choice of treatment group . All patients were observed for 10 years by clinical evaluation and question naires . The results , evaluated by patient and physician , were rated as excellent , fair , unchanged , or worse . RESULTS After a period of 3 months , relief of pain had occurred in most patients . Some had relief earlier , whereas for others it took 1 year . After a period of 4 years , excellent or fair results were found in half of the patients selected for conservative treatment , and in four fifths of the patients selected for surgery . Patients with an unsatisfactory result from conservative treatment were offered delayed surgery after 3 to 27 months ( median , 3.5 months ) . The treatment result of delayed surgery was essentially similar to that of the initial group . The treatment result for the patients r and omized for surgical treatment was considerably better than for the patients r and omized for conservative treatment . Clinical ly significant deterioration of symptoms during the final 6 years of the follow-up period was not observed . Patients with multilevel afflictions , surgically treated or not , did not have a poorer outcome than those with single-level afflictions . Clinical or radiologic predictors for the final outcome were not found . There were no dropouts , except for 14 deaths . CONCLUSIONS The outcome was most favorable for surgical treatment . However , an initial conservative approach seems advisable for many patients because those with an unsatisfactory result can be treated surgically later with a good outcome",
"Study Design A prospect i ve survey of patients seeking primary care for low back pain . Clinical and psychosocial data , available at presentation , were explored for predictors of outcome at 1 year . Objectives To determine the relative value of clinical and psychosocial variables for early identification of patients with a poor prognosis . Summary of Background Data Current treatment strategies for low back pain have failed to stem the rising levels of disability . Psychosocial factors have been shown to be important determinants of response to therapy in chronic patients , but the contribution from similar data in acute or subchronic patients has not been comprehensively investigated . Methods Two hundred fifty-two patients with low back pain , presenting to primary care , underwent a structured clinical interview and completed a battery of psychosocial instruments . Follow-up was done by mail at 1 year ; outcome was measured using a back pain disability question naire . Predictive relationships were sought between the data at presentation and disability at follow-up . Results Most patients showed improved disability and pain scores , although more than half had persisting symptoms . Eighteen percent showed significant psychological distress at presentation . Multiple regression analysis showed the level of persisting disability to depend principally on measures in the psychosocial domain ; for acute cases outcome is also dependent on the absence or presence of a previous history of low back trouble . Discriminant models successfully allocated typically 76 % of cases to recovered/not-recovered groups , largely on the basis of psychosocial factors evident at presentation . Conclusions Early identification of psychosocial problems is important in underst and ing , and hopefully preventing , the progression to chronicity in low back trouble",
"Study Design . Prospect i ve , comparative cohort study . Objective . To investigate the prognostic significance of central ization in patients with subacute sciatica and referred symptoms . Summary of Background Data . Previous studies have shown that central ization occurs commonly in the nonspecific low back population , and its occurrence is associated with a good prognosis . The phenomenon has never been evaluated in a population with sciatica and referred symptoms . Methods . The sample pool was 104 consecutive patients referred for investigation of possible disc herniation . Of these patients , 60 were recruited into the study and underwent a st and ardized mechanical evaluation using repeated end-range movements , while symptom response was monitored to expose 2 groups : central ization group ( CG ) and non central ization group ( NCG ) . All patients were treated in the same way and were followed for one year . If patients did not have improvement surgery was considered . Outcomes included back and leg pain , disability , Nottingham Health Profile , and surgical outcome . Results . There were 25 patients who were classified in the CG , 35 in the NCG , and other baseline characteristics were similar between groups . At 1 , 2 , and 3 months , the CG had significantly better outcomes than the NCG . At 2 months , the CG had more improvements in leg pain ( P = 0.007 ) , disability ( P = Nottingham Health Profile ( P = 0.001 ) . After 1 year , disability was less in the CG ( P = 0.029 ) . In the CG , 3 patients underwent surgery , in the NCG , 16 ( P = 0.01 ) . The odds ratio for surgery in the NCG was 6.2 . Conclusion . Patients with sciatica and suspected disc herniation who have a central ization response to a mechanical evaluation will have significantly better outcomes . Patients who do not have central ization will be 6 times more likely to undergo surgery",
"Study Design . A prospect i ve cohort study on low back pain in consecutive patients in general practice , in which potential prognostic indicators at baseline and at the 1-year follow-up examination were assessed by means of four weekly question naires . Objectives . To identify prognostic indicators of the duration of low back pain in general practice and the occurrence of a relapse . Background . Little is known about the prognosis of low back pain in general practice . Different design s and different results of preceding studies make drawing conclusions about the prognostic indicators , if any , of the course of low back pain in general practice difficult . Methods . For a period of 2 years , 15 general practitioners from Amsterdam and surrounding areas studied consecutive patients with chronic low back pain and those with a recent onset of low back pain . A large number of potential prognostic indicators were assessed at the initial visit . After the initial visit , each patient was monitored for a period of 12 months . The follow-up assessment was conducted with four weekly postal question naires . The associations among the potential prognostic indicators , the duration of the index episode , and the occurrence of a relapse were analyzed using multivariate Cox regression and logistic regression analysis , respectively . Results . Of the 605 patients identified , 443 were included in the follow-up period of assessment ; the question naires were completed by 269 patients . In general , patients with less severe low back pain participated less often or did not complete the follow-up study . Thirty-five percent of the population still experienced low back pain after 12 weeks , and 10 % still experienced it after 1 year . Approximately three of every four patients whose index episode ended before the end of the follow-up period had one or more relapses within a year . The analysis result ed in a model with four variables predicting the duration of the low back pain , including \" the duration of the low back pain preceding the initial visit , \" \" receiving physical therapy , \" \" pain intensity , \" and \" history of back surgery . \" Daily functioning appeared to be the only variable that was significantly associated with the occurrence of a relapse . Conclusions . Only a few variables appear to be related to the clinical course of low back pain seen in general practice . In particular , the duration preceding the initial visit and , unexpectedly , receiving physical therapy were both associated with a longer duration of low back pain",
"OBJECTIVE To determine predictive factors for radical treatment ( nucleolysis or surgery ) after in-hospital conservative management of low back pain with sciatica ( LBPS ) . PATIENTS AND METHODS A st and ardized form was used to collect data on 134 patients admitted for conservative treatment of LBPS . Subsequent radical procedures were recorded 11 to 24 months after discharge . RESULTS Forty-seven patients required radical treatment after discharge . Significant risk factors for radical treatment in the univariate analysis were taller stature , use of a lumbar support , more preadmission epidural injections , a positive straight leg-raising test , and a disk herniation diameter of at least 50 % of the spinal canal diameter . Protective factors were onset within the month preceding admission and normal range of motion of the lumbar spine . In the multivariate analysis , symptom duration longer than one month , use of a lumbar support prior to admission , and a positive straight leg-raising test were associated with radical treatment . A positive straight leg-raising test was the only significant clinical risk factor in the subset of patients investigated by computed tomography ( CT ) . When CT findings were added to the model , only size of the herniation was significant . CONCLUSION Sixty-five percent of patients admitted for conservative treatment of LBPS do not receive radical treatment during a mean follow-up of 18 months . Several factors are associated with the likelihood of radical treatment",
"BACKGROUND Lumbosacral pain is a significant social problem . Effective treatment of this ailment should be based on thorough diagnostic work-up . The goal of the present study was to determine which physical examination findings can help predict a positive outcome of physiotherapy , including kinesitherapy and physical therapy , aim ed at symptomatic improvement . MATERIAL AND METHODS The study group consisted of 50 patients with lumbosacral pain syndromes presenting as lumbalgia and ischialgia . RESULTS Statistically significant correlations were ascertained between certain physical examination findings before the therapy and after the therapy . CONCLUSION The crossed Lasegue sign was the only component of the physical examination that correlated with the dynamic efficacy of the rehabilitation treatment",
"Abstract . Return to work ( RTW ) is the primary goal in the rehabilitation of patients with chronic low back pain . In spite of expensive rehabilitative efforts , many patients do not RTW . To increase cost effectiveness , predictive tests for non-RTW are needed to select patients for rehabilitation . The reliability of these tests must be high , to prevent exclusion of patients who might improve . This study evaluates the reliability and predictive validity of four tests and the following psychosocial factors for non-RTW : nationality , off-work duration , unemployment and work load . It was design ed as a prospect i ve cohort study of 99 patients with chronic low back pain . Upon entry , physical work load , time off work , unemployment and nationality were recorded . The study investigated four tests with an anticipated prognostic value for non-RTW : the Numeric Pain Rating Scale ( NRS , 9–10 of a maximum of 10 ) , the Step Test and Pseudo Strength Test ( precipitous cessation ) and Behavioural Signs . After 12 months , the RTW rate was obtained from the physicians responsible for sick-listing by postal survey . The response rate regarding RTW was 91 % at 1 year . The RTW rate at 1 year was 20 % . All investigated tests significantly correlated with non-RTW . Regression analysis showed that the best prediction of non-RTW was obtained when at least two out of the four tests were positive ( positive predictive value 0.97 , sensitivity 0.45 ) . Unemployment , time off work , nationality and physical work load were less predictive . The results show that the combination of the four prognostic tests allows a very reliable prognosis of non-RTW . The cost effectiveness of rehabilitation aim ing at RTW will , therefore , be increased by excluding patients with two or more positive tests",
"OBJECTIVE To examine the predictive validity of posterior-anterior ( PA ) mobility testing in a group of patients with low back pain ( LBP ) . DESIGN R and omized controlled trial . SETTING Outpatient physical therapy clinics . PARTICIPANTS Patients with LBP ( N=131 ; mean age + /- st and ard deviation , 33.9+/-10.9 y ; range , 19 - 59 y ) , and a median symptom duration of 27 days ( range , 1 - 5941 d ) . Patients completed a baseline examination , including PA mobility testing , and were categorized with respect to both hypomobility and hypermobility ( present or absent ) , and treated for 4 weeks . INTERVENTION Seventy patients were r and omized to an intervention involving manipulation and 61 to a stabilization exercise intervention . MAIN OUTCOME MEASURES Oswestry Disability Question naire ( ODQ ) scores were collected at baseline and after 4 weeks . Three-way repeated measures analyses of variance ( ANOVAs ) were performed to assess the effect of mobility categorization and intervention group on the change on the ODQ with time . Number-needed-to-treat ( NNT ) statistics were calculated . RESULTS Ninety-three ( 71.0 % ) patients were judged to have hypomobility present and 15 ( 11.5 % ) were judged with hypermobility present . The ANOVAs result ed in significant interaction effects . Pairwise comparisons showed greater improvements among patients receiving manipulation categorized with hypomobility present versus absent ( mean difference , 23.7 % ; 95 % confidence interval [ CI ] , 5.1%-42.4 % ) , and among patients receiving stabilization categorized with hypermobility present versus absent ( mean difference , 36.4 % ; 95 % CI , 10.3%-69.3 % ) . For patients with hypomobility , failure rates were 26 % with manipulation and 74.4 % with stabilization ( NNT=2.1 ; 95 % CI , 1.6 - 3.5 ) . For patients with hypermobility , failure rates were 83.3 % and 22.2 % for manipulation and stabilization , respectively ( NNT=1.6 ; 95 % CI , 1.2 - 10.2 ) . CONCLUSIONS Patients with LBP judged to have lumbar hypomobility experienced greater benefit from an intervention including manipulation ; those judged to have hypermobility were more likely to benefit from a stabilization exercise program",
"Study Design . Systematic review and meta- analysis . Objective . To assess the efficacy of opioids in adults with chronic low back pain ( CLBP ) . Summary of Background Data . Opioids for CLBP has increased dramatically . However , the benefits and risks remain unclear . Methods . We up date d a 2007 Cochrane Review through October 2012 of r and omized controlled trials from multiple data bases . Use of noninjectable opioids in CLBP for at least 4 weeks was compared with placebo or other treatments ; comparisons with different opioids were excluded . Outcomes included pain and function using st and ardized mean difference ( SMD ) or risk ratios with 95 % confidence intervals ( CIs ) , and absolute risk difference with 95 % CI for adverse effects . Study quality was evaluated using Grading of Recommendations Assessment , Development , and Evaluation criteria . Results . Fifteen trials ( 5540 participants ) , including twelve new , met the criteria . Tramadol was better than placebo for pain ( SMD , −0.55 ; 95 % CI , −0.66 to −0.44 ) and function ( SMD , −0.18 ; 95 % CI , −0.29 to −0.07 ) . Compared with placebo , transdermal buprenorphine decreased pain ( SMD , −2.47 ; 95 % CI , −2.69 to −2.25 ) , but not function ( SMD , −0.14 ; 95 % CI , −0.53 to 0.25 ) . Strong opioids ( morphine , hydromorphone , oxycodone , oxymorphone , and tapentadol ) , were better than placebo for pain ( SMD , −0.43 ; 95 % CI , −0.52 to −0.33 ) and function ( SMD , −0.26 ; 95 % CI , −0.37 to −0.15 ) . One trial demonstrated little difference with tramadol compared with celecoxib for pain relief . Two trials ( 272 participants ) found no difference between opioids and antidepressants for pain or function . Review ed trials had low to moderate quality , high drop-out rates , short duration , and limited interpretability of functional improvement . No serious adverse effects , risks ( addiction or overdose ) , or complications ( sleep apnea , opioid-induced hyperalgesia , hypogonadism ) were reported . Conclusion . There is evidence of short-term efficacy ( moderate for pain and small for function ) of opioids to treat CLBP compared with placebo . The effectiveness and safety of long-term opioid therapy for treatment of CLBP remains unproven . Level of Evidence :",
"OBJECTIVE To identify demographic and clinic-related predictors for successful outcome in patients with persistent low-back pain who received chiropractic treatment . DESIGN Prospect i ve uncontrolled multicenter study with internal control groups . SUBJECTS Each of 115 Norwegian chiropractors , out of 205 invited , were asked to recruit 10 consecutive patients who had low-back pain for at least 2 weeks at the time of consultation and a minimum of 30 days altogether within the preceding year . In all , 875 patients were included at baseline . The response rates at the fourth visit and at 3 and 12 months were 799 , 598 , and 512 , respectively . METHODS Baseline data were obtained through question naires administered to chiropractic patients and to their treating chiropractors ; clinical information was obtained through question naires at the fourth visit from patients and chiropractors . Outcome was obtained from patients at the fourth visit . Mail surveys of patients were conducted after 3 and 12 months , and additional information was obtained from chiropractors at 12 months in relation to treatment history . POTENTIAL PREDICTORS : Demography and information on past and present history , clinical findings , and prognosis . OUTCOME VARIABLE Number of low-back pain\"free patients ( defined as those with a maximum pain score of 1/10 and a maximum Oswestry score of 15/100 ) . DATA ANALYSIS Positive predictive values and relative risks were calculated for each categorized predictor variable singly and in combination in relation to being low-back pain free at the 3 follow-up surveys . RESULTS Treatment outcome at the fourth visit was best predicted by a model containing the following 5 variables : sex , social benefit , severity of pain , duration of continuous pain at first consultation , and additional neck pain ( odds ratios between 2.2 and 4.3 ) . A similar profile was found at 3 months , but 2 different variables ( relating to disability ) were the final variables in relation to the 12-month status . These final models were best at predicting absence of treatment success . Being low-back pain free at the fourth visit was a strong predictor for being low-back pain free both at 3 months and 12 months , with relative risks of 3.0 ( 2.2 - 4.8 ) and 3.1 ( 1.5 - 6.5 ) , respectively . CONCLUSION In patients with persistent low-back pain , it is possible to exclude from treatment those who are unlikely to become low-back pain free after chiropractic care and to do this before they have been examined clinical ly . Early recovery is a strong predictor for outcome up to 1 year later",
"Study Design . A prospect i ve , cohort study of patients with nonradicular low back pain referred to physical therapy . Objective . Develop a clinical prediction rule for identifying patients with low back pain who improve with spinal manipulation . Summary of Background Data . Development of clinical prediction rules for classifying patients with low back pain who are likely to respond to a particular intervention , such as manipulation , would improve clinical decision-making and research . Methods . Patients with nonradicular low back pain underwent a st and ardized examination and then underwent a st and ardized spinal manipulation treatment program . Success with treatment was determined using percent change in disability scores over three sessions and served as the reference st and ard for determining the accuracy of examination variables . Examination variables were first analyzed for univariate accuracy in predicting success and then combined into a multivariate clinical prediction rule . Results . Seventy-one patients participated . Thirty-two had success with the manipulation intervention . A clinical prediction rule with five variables ( symptom duration , fear – avoidance beliefs , lumbar hypomobility , hip internal rotation range of motion , and no symptoms distal to the knee ) was identified . The presence of four of five of these variables ( positive likelihood ratio = 24.38 ) increased the probability of success with manipulation from 45 % to 95 % . Conclusion . It appears that patients with low back pain likely to respond to manipulation can be accurately identified before treatment",
"Study Design . R and omized Clinical Trial . Objective . To identify a subgroup of patients with low back pain who are likely to respond favorably to an intervention including mechanical traction . Summary of Background Data . Previous research has failed to find evidence supporting traction for patients with low back pain . Previous studies have used heterogeneous sample s , although clinical experts tend to recommend traction for a more limited subgroup of patients with low back pain . Methods . Sixty-four subjects ( mean age 41.1 year , 56.3 % female ) with low back and leg pain and signs of nerve root compression were r and omized to receive a 6-week extension-oriented intervention with or without mechanical traction during the first 2 weeks . Between-group comparisons were conducted for changes in pain , disability , and fear-avoidance beliefs . Baseline variables were explored for potential as subgrouping criteria defining a subgroup of subjects likely to benefit from traction . Results . The group receiving traction showed greater improvements in disability ( adjusted mean difference in Oswestry change 7.2 points ) and fear-avoidance beliefs ( adjusted mean difference in FABQPA change 2.6 points ) after 2 weeks . There were no between-group differences after 6 weeks . Two baseline variables were associated with greater improvements with traction treatment ; peripheralization with extension movements and a crossed straight leg raise . Conclusion . A subgroup of patients likely to benefit from mechanical traction may exist . The results of this study suggest this subgroup is characterized by the presence of leg symptoms , signs of nerve root compression , and either peripheralization with extension movements or a crossed straight leg raise . Further research is needed to vali date this finding",
"This prospect i ve study investigated the relationship between behavioral sign scores ( from Waddell ) and the return to work status of chronic low-back pain patients who completed a work-oriented physical rehabilitation program without formal facility-related psychologic or social services . Further , the authors monitored the effect of this program on changing these scores . The program consisted of physical reconditioning through resistive exercises , flexibility and aerobic training , posture and body mechanics education , and progressive work simulation tasks and activities of daily living . One hundred eighty-three nonworking or partially disabled low-back pain patients with an average duration of 8.7 months ' disability were included in the study . The presence of each of eight behavioral signs was tested for on entry and again on completion of the program . Analysis showed a significant drop in behavioral sign scores for patients who successfully returned to work . There was no significant reduction in scores for patients who did not return to work . The results suggest these signs may predict the effectiveness of treating chronic low-back pain patients in a return-to-work physical rehabilitation program . Conversely , screening for behavioral signs may identify low-back pain patients who would benefit from intensive behavioral and psychiatric testing and intervention efforts",
"STUDY DESIGN Prospect i ve cohort study nested in a r and omized clinical trial . OBJECTIVE To investigate the prognostic value of pain response classification at initial physiotherapy examination in patients with low back pain ( LBP ) who are sick-listed . BACKGROUND Recurrent and chronic LBP accounts for a substantial proportion of all absence from work . In predicting outcome in patients with LBP , psychosocial factors are thought to play an important role , while findings from clinical examination seem to be of more limited value . Mechanical evaluation , using repeated end range spinal movements that result in specific pain responses , has been shown to be of some value . METHODS The study included 351 patients sick-listed because of LBP with or without sciatica . Prior to clinical examination , the patients completed a comprehensive question naire including questions on pain , function , and psychosocial factors . The physiotherapy examination included a st and ardized mechanical evaluation . Patients were classified into 3 groups according to their pain response : central ization , peripheralization , or no response . Outcomes were obtained by national register data , medical records , and a postal question naire at 1 year . RESULTS At 1-year follow-up , 65 % of the patients had returned to work . All pain response groups showed significant and clinical ly important improvements in both pain and disability . No significant differences were found between pain response groups in any outcome measure . Results remained unchanged after adjustment for potential confounders . CONCLUSION The prognostic value of pain response classification seems limited in patients sick-listed from work because of LBP",
"Objectives : To determine whether treatment related pain reduction on the short- and long-term is predicted by different baseline variables , and with different accuracy , in patients with chronic low back pain as compared with those with chronic neck pain . Design and Methods : A single blinded prospect i ve cohort study based on patients with chronic musculoskeletal pain in the lower back ( N = 167 ) or the neck ( N = 136 ) who completed a 4-week multimodal rehabilitation program . At admission , each patient was evaluated on 17 potential predictors , including pain characteristics and physical , sociodemographic , and psychosocial-behavioral variables . Changes in self-reported pain intensity in the lower back or the neck between the pretreatment evaluation and those performed immediately after , and 12 months after the rehabilitation program , were assessed . Results : Logistic regression models revealed that change in pain intensity could be predicted with good specificity but with poor sensitivity both for patients with chronic low back pain and chronic neck pain . Significant predictors among the neck pain patients were high endurance , low age , high pain intensity , few other symptoms , low need of being social , to do things with others , and to be helped , along with optimistic attitudes on how the pain will interfere with daily life . Among the low back pain patients , high pain intensity , low levels of pain severity , and high affective distress were important predictors . Variables such as sex , sick leave history , working status , accident , pain duration , and depressive symptoms demonstrated no predictive value . Short- and long-term pain outcome was equally predictable and predicted by almost the same variables . Conclusions : Patients who reported unchanged or increased pain after multimodal treatment could be predicted with good accuracy , whereas those who reported decreased pain were more difficult to identify . Treatment-related pain alteration in chronic low back pain seems to be predicted by partly different variables than in chronic neck pain",
"Study Design . A controlled clinical trial . Objectives . To examine the long‐term effect of an informative approach to low back pain . Summary of Background Data . In management and prevention of low back pain , back school based on an ergonomic approach have played an important role . The effect of such informative interventions is not clear . Methods . A 5‐year follow‐up study was done on patients included in a previous study . The outcome was measured by return to work or still on sick leave . The patients were allocated to an intervention group ( n = 245 ) and a control group ( n = 244 ) . Only the intervention group was called in for examination and intervention and answered a battery of tests for psychological and health factors . The intervention apart from the clinical examination consisted of education in a \" mini back school . \" The program was based on a new medical model for low back pain . Results . Forty‐seven ( 19 % ) of the patients in the intervention group , compared with 84 patients ( 34 % ) in the control group , were still on sick leave after 5 years ( P fewer recurrences of sick leave ( P Based on Internal Health Locus of Control , number of children , and income , 75 % were correctly classified as nonreturners in the intervention group . Conclusions . This study indicates that subchronic low back pain may be managed successfully with an approach that includes clinical examination combined with information for patients about the nature of the problem , provided in a manner design ed to reduce fear and give them reason to resume light activity",
"BACKGROUND Transforaminal injection of steroids ( TFIS ) is effective for some patients with lumbar radicular pain caused by disc herniation . Factors associated with better outcomes are unknown . OBJECTIVE To identify clinical and radiological features predictive of a favorable response to TFIS . METHODS Seventy-one patients with lumbar radicular pain caused by disc herniation were treated with TFIS as part of a previously reported , r and omized , clinical trial . The clinical features analyzed were the presence of neurologic symptom , neurologic signs , and the duration of sciatica . Radiological features evaluated using magnetic resonance imaging ( MRI ) were the segmental level of the pathology , the location and morphological features of the disc herniation , the cross-sectional area of the disc herniation and its ratio to the cross-sectional area of the spinal canal , and the grade of nerve root compression . RESULTS None of the clinical features was associated with successful outcome from treatment . The only radiological feature associated with successful outcome was the grade of nerve root compression . Of patients with low- grade root compression , 75 % responded favorably to TFIS . Only 26 % of patients with high- grade nerve root compression responded . DISCUSSION These results indicate that TFIS is more often successful in patients without significant compression of the nerve root and , therefore , in whom an inflammatory basis for radicular pain is most likely . In such patients , a success rate of 75 % renders TFIS an attractive alternative to surgery . In patients with significant compression of the nerve root , the likelihood of benefiting from TFIS is low . The success rate may be no more than that of a placebo effect , and surgery may be a more appropriate consideration",
"OBJECTIVES We aim ed to examine the prognosis of acute low back pain ( LBP ) in patients in general practice and to identify prognostic factors associated with the long-term prognosis based on information immediately available to the GP . METHOD We conducted a prospect i ve cohort study in general practice in Denmark . The patients were those aged 18 - 60 years consulting their GP due to an episode of LBP lasting less than 2 weeks . The GPs collected data regarding 34 exposure variables , including their global assessment of the likelihood of chronic LBP . Outcome variables were collected from the patients after 1 , 6 and 12 months . The outcome measures were days on sick leave , and functional or complete recovery from LBP . RESULTS In total , 503 ( 96 % ) patients were followed during the whole study period . Fifty per cent of the patients on sick leave returned to work within 8 days ; after 1 year , only 2 % remained on sick leave . At the 1-year follow-up , 45 % of the patients continued to complain of LBP . Logistic regression analyses showed that the factors most significantly associated with poor long-term LBP outcome were ( i ) severity of LBP at inclusion , ( ii ) assessment s by the GP of susceptibility to develop chronic LBP and ( iii ) a history of LBP having caused previous sick leave . CONCLUSIONS LBP in general practice has a good prognosis with regard to sick leave , but a high proportion of patients continue to complain of LBP . We were not able to identify objective measures that strongly predict the prognosis of the individual LBP patient . The overall assessment by the GPs seems to be the most important predictor associated with the long-term outcome",
"OBJECTIVE To describe physical measures used in patients with back pain when no specific treatment is given , to examine associations between change over time in these measures and changes in pain and back-related disability , and to study the value of physical measures at baseline and at a 4-week follow-up to predict outcome at 12 months . DESIGN A prospect i ve consecutive study . SUBJECTS Forty-four patients presenting with low back pain in primary care . METHODS The patients underwent a physical examination at baseline and at 4 weeks . Follow-up was carried out using question naires until 12 months . Linear regression was used to identify predictors . RESULTS Most measures had improved significantly at the 4-week follow-up . Thoracolumbar rotation , isometric endurance back extensors , and fingertip-to-floor distance at 4 weeks were significant predictors for pain intensity and back-related disability at the 12-month follow-up . Eighteen out of 44 patients reported an increase in pain after the assessment of the physical measures at baseline . This group of patients improved more in physical measures between baseline and the 4-week follow-up . CONCLUSION Physical measures assessed at the 4-week follow-up , but not at baseline , could provide important additional information for identifying those patients at risk for worse outcome in pain or back-related disability at 12 months",
"The inability to predict outcome in patients with low-back pain seriously impedes clinical trials and leads to inappropriate or unnecessary treatment . This prospect i ve study investigated the value of multivariable mathematical models to predict the 1-year clinical course of 109 patients with low-back trouble ( LBT ) . Discriminant analysis was used to determine predictive models for outcome groups at 1 month , 3 months and 1 year . The variables selected in the analyses were subsets of 29 items from a clinical interview at presentation . These included anamnestic features of the first episode as well as symptomatic details and results from clinical tests for the current spell . The derived models successfully discriminated outcome groups with estimates of sensitivity and specificity ranging from 63 to 99 % . When models from one set of patients were tested for predictive accuracy by the application of them to a different set , nonrecovery and satisfactory improvement were predicted with a 76–100 % success rate . The results affirmed the importance of considering combinations of interrelated variables for prediction and discrimination in LBT . This work has demonstrated that outcome can be predicted successfully by the use of mathematic models based just on presentation data . The ability to determine homogenous groups in respect to outcome is seen as an important aid to therapeutic research ; further work will enable refinement of these models for general clinical use and for incorporation into computer-based interview systems"
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BACKGROUND Large gaps in lipid treatment and medication adherence persist in high-risk out patients in the United States . Health information technology ( HIT ) is being applied to close quality gaps in chronic illness care , but its utility for lipid management has not been widely studied . OBJECTIVE To perform a qualitative review of the impact of HIT interventions on lipid management processes of care ( screening or testing ; drug initiation , titration or adherence ; or referrals ) or clinical outcomes ( percent at low density lipoprotein cholesterol goal ; absolute lipid levels ; absolute risk scores ; or cardiac hospitalizations ) in out patients with coronary heart disease or at increased risk . METHODS PubMed and Google Scholar data bases were search ed using Medical Subject Headings related to clinical informatics and cholesterol or lipid management . English language articles that described a r and omized controlled design , tested at least one HIT tool in high risk out patients , and reported at least 1 lipid management process measure or clinical outcome , were included . RESULTS Thirty-four studies that enrolled 87,874 persons were identified . Study ratings , outcomes , and magnitude of effects varied widely . Twenty-three trials reported a significant positive effect from a HIT tool on lipid management , but only 14 showed evidence that HIT interventions improve clinical outcomes . There was mixed evidence that provider-level computerized decision support improves outcomes . There was more evidence in support of patient-level tools that provide connectivity to the healthcare system , as well as system-level interventions that involve data base monitoring and outreach by central ized care teams . CONCLUSION R and omized controlled trials show wide variability in the effects of HIT on lipid management outcomes . Evidence suggests that multilevel HIT approaches that target not only providers but include patients and systems approaches will be needed to improve lipid treatment , adherence and quality
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"Background — Indirect evidence shows that alerting users with clinical decision support systems seems to change behavior more than requiring users to actively initiate the system . However , r and omized trials comparing these methods in a clinical setting are lacking . We studied the effect of both alerting and on-dem and decision support with respect to screening and treatment of dyslipidemia based on the guidelines of the Dutch College of General Practitioners . Methods and Results — In a clustered r and omized trial design , 38 Dutch general practice s ( 77 physicians ) and 87 886 of their patients ( 39 433 men 18 to 70 years of age and 48 453 women 18 to 75 years of age ) who used the ELIAS electronic health record participated . Each practice was assigned to receive alerts , on-dem and support , or no intervention . We measured the percentage of patients screened and treated after 12 months of follow-up . In the alerting group , 65 % of the patients requiring screening were screened ( relative risk versus control=1.76 ; 95 % confidence interval , 1.41 to 2.20 ) compared with 35 % of patients in the on-dem and group ( relative risk versus control=1.28 ; 95 % confidence interval , 0.98 to 1.68 ) and 25 % of patients in the control group . In the alerting group , 66 % of patients requiring treatment were treated ( relative risk versus control=1.40 ; 95 % confidence interval , 1.15 to 1.70 ) compared with 40 % of patients ( relative risk versus control=1.19 ; 95 % confidence interval , 0.94 to 1.50 ) in the on-dem and group and 36 % of patients in the control group . Conclusion — The alerting version of the clinical decision support systems significantly improved screening and treatment performance for dyslipidemia by general practitioners",
"OBJECTIVE —The purpose of this study was to determine whether implementation of a multicomponent organizational intervention can produce significant change in diabetes care and outcomes in community primary care practice s. RESEARCH DESIGN AND METHODS —This was a group-r and omized , controlled clinical trial evaluating the practical effectiveness of a multicomponent intervention ( TRANSLATE ) in 24 practice s. The intervention included implementation of an electronic diabetes registry , visit reminders , and patient-specific physician alerts . A site coordinator facilitated previsit planning and a monthly review of performance with a local physician champion . The principle outcomes were the percentage of patients achieving target values for the composite of systolic blood pressure ( SBP ) mmHg , LDL cholesterol A1C months , 69,965 visits from 8,405 adult patients with type 2 diabetes were recorded from 238 health care providers in 24 practice s from 17 health systems . Diabetes process measures increased significantly more in intervention than in control practice s , giving net increases as follows : foot examinations 35.0 % ( P annual eye examinations 25.9 % ( P renal testing 28.5 % ( P A1C testing 8.1%(P blood pressure monitoring 3.5 % ( P = 0.05 ) ; and LDL testing 8.6 % ( P Mean A1C adjusted for age , sex , and comorbidity decreased significantly in intervention practice s ( P recommended clinical values for SBP , A1C , and LDL than control clinics ( P = 0.002 ) . CONCLUSIONS — Introduction of a multicomponent organizational intervention in the primary care setting significantly increases the percentage of type 2 diabetic patients achieving recommended clinical outcomes ",
"Objective To investigate whether an internet based , nurse led vascular risk factor management programme promoting self management on top of usual care is more effective than usual care alone in reducing vascular risk factors in patients with clinical ly manifest vascular disease . Design Prospect i ve r and omised controlled trial . Setting Multicentre trial in secondary and tertiary healthcare setting . Participants 330 patients with a recent clinical manifestation of atherosclerosis in the coronary , cerebral , or peripheral arteries and with at least two treatable risk factors not at goal . Intervention Personalised website with an overview and actual status of patients ’ risk factors and mail communication via the website with a nurse practitioner for 12 months ; the intervention combined self management support , monitoring of disease control , and drug treatment . Main outcome measures The primary endpoint was the relative change in Framingham heart risk score after 1 year . Secondary endpoints were absolute changes in the levels of risk factors and the differences between groups in the change in proportion of patients reaching treatment goals for each risk factor . Results Participants ’ mean age was 59.9 ( SD 8.4 ) years , and most patients ( n=246 ; 75 % ) were male . After 1 year , the relative change in Framingham heart risk score of the intervention group compared with the usual care group was −14 % ( 95 % confidence interval −25 % to −2 % ) . At baseline , the Framingham heart risk score was higher in the intervention group than in the usual care group ( 16.1 ( SD 10.6 ) v 14.0 ( 10.5 ) ) , so the outcome was adjusted for the separate variables of the Framingham heart risk score and for the baseline Framingham heart risk score . This produced a relative change of −12 % ( −22 % to −3 % ) in Framingham heart risk score for the intervention group compared with the usual care group adjusted for the separate variables of the score and −8 % ( −18 % to 2 % ) adjusted for the baseline score . Of the individual risk factors , a difference between groups was observed in low density lipoprotein cholesterol ( −0.3 , −0.5 to −0.1 , mmol/L ) and smoking ( −7.7 % , −14.9 % to −0.4 % ) . Some other risk factors tended to improve ( body mass index , triglycerides , systolic blood pressure , renal function ) or tended to worsen ( glucose concentration , albuminuria ) . Conclusion An internet based , nurse led treatment programme on top of usual care for vascular risk factors had a small effect on lowering vascular risk and on lowering of some vascular risk factors in patients with vascular disease . Trial registration Clinical trials NCT00785031",
"BACKGROUND Telemedicine is a promising but largely unproven technology for providing case management services to patients with chronic conditions who experience barriers to access to care or a high burden of illness . METHODS The authors conducted a r and omized , controlled trial comparing telemedicine case management to usual care , with blinding of those obtaining outcome data , in 1,665 Medicare recipients with diabetes , aged 55 years or greater , and living in federally design ated medically underserved areas of New York State . The primary endpoints were HgbA1c , blood pressure , and low-density lipoprotein ( LDL ) cholesterol levels . RESULTS In the intervention group ( n = 844 ) , mean HgbA1c improved over one year from 7.35 % to 6.97 % and from 8.35 % to 7.42 % in the subgroup with baseline HgbA1c > or = 7 % ( n = 353 ) . In the usual care group ( n = 821 ) mean HgbA1c improved over one year from 7.42 % to 7.17 % . Adjusted net reductions ( one-year minus baseline mean values in each group , compared between groups ) favoring the intervention were as follows : HgbA1c , 0.18 % ( p = 0.006 ) , systolic and diastolic blood pressure , 3.4 ( p = 0.001 ) and 1.9 mm Hg ( p LDL cholesterol , 9.5 mg/dL ( p HgbA1c > or = 7 % , net adjusted reduction in HgbA1c favoring the intervention group was 0.32 % ( p = 0.002 ) . Mean LDL cholesterol level in the intervention group at one year was 95.7 mg/dL. The intervention effects were similar in magnitude in the subgroups living in New York City and upstate New York . CONCLUSION Telemedicine case management improved glycemic control , blood pressure levels , and total and LDL cholesterol levels at one year of follow-up",
"BACKGROUND Primary nonadherence occurs when new prescriptions are not dispensed . Little is known about how to reduce primary nonadherence . We performed a r and omized controlled trial to evaluate an automated system to decrease primary nonadherence to statins for lowering cholesterol . METHODS Adult members of Kaiser Permanente Southern California with no history of statin use within the past year who did not fill a statin prescription after 1 to 2 weeks were passively enrolled . The intervention group received automated telephone calls followed 1 week later by letters for continued nonadherence ; the control group received no outreach . The primary outcome was a statin dispensed up to 2 weeks after delivery of the letter . Secondary outcomes included refills at intervals up to 1 year . Intervention effectiveness was determined by intent-to-treat analysis and Fisher exact test . Subgroups were examined using logistic regression . RESULTS There were 2606 participants in the intervention group and 2610 in the control group . Statins were dispensed to 42.3 % of intervention participants and 26.0 % of control participants ( absolute difference , 16.3 % ; P relative risk for the intervention vs control group was 1.63 ( 95 % CI , 1.50 - 1.76 ) . Intervention effectiveness varied slightly by age ( P = .045 ) but was effective across all age strata . Differences in the frequency of statin dispensations persisted up to 1 year ( P primary nonadherence to statin medications . Because of low marginal costs for outreach , this strategy appears feasible for reducing primary nonadherence . This approach may generalize well to other medications and chronic conditions",
"PURPOSE Dyslipidemia treatment dramatically decreases coronary heart disease risk in diabetes , yet only a minority of these patients are screened or achieve optimal low-density lipoprotein ( LDL ) cholesterol levels . Our aim was to increase the percentage of diabetic patients in whom lipid management was achieved through electronic and direct educational detailing . METHODS The study cohort comprised 884 diabetic patients at 12 primary care practice s. Practice sites were r and omized to one of three intervention groups : electronic educational detailing , direct ( face-to-face ) educational detailing , or control . Direct and electronic detailing were performed over a 12-month period . All sites were notified of our goal to enhance lipid testing among diabetic patients . Chart abstract ion was performed 15 months after the start of the intervention . For the entire population ( n=884 ) , the proportion of patients with lipid testing was calculated , and changes from pre- to postintervention were compared across groups . We compared pre- and postintervention LDL-cholesterol changes between groups using least square means to account for site variation . RESULTS Favorable provider actions increased significantly with the intervention ( + 22 % compared with + 6 % in controls , P=.01 ) . By logistic regression , electronic detailing increased the likelihood of lipid testing ( odds ratio 3.0 , confidence interval 1.6 - 5.7 ) , as did direct detailing ( odds ratio 1.8 , confidence interval 0.9 - 3.7 ) in patients with no preintervention LDL test ( n=432 ) . Lipid testing tended to increase to a greater extent at intervention sites ( + 23 % for the combination of electronic and direct detailing vs + 11 % for controls , P=.06 ) . CONCLUSIONS Brief educational detailing either through direct or electronic communication favorably impacts provider behavior regarding dyslipidemia care for diabetic patients",
"Background Elevated low-density lipoprotein ( LDL ) cholesterol is a leading risk factor for cardiovascular disease . Despite the availability of proven interventions to lower LDL cholesterol , their use remains subobtimal . Many websites provide interactive , tailored advice on cardiovascular risk in an attempt to help bridge this evidence - practice gap , yet there is little evidence that provision of such a tool is effective in changing practice . Objectives The objective was to define the effects on use of cholesterol-lowering interventions of a consumer-targeted tailored advice website . Methods This was a prospect i ve , double-blind , r and omized controlled trial open to any adult Australian with access to the Internet . A total of 2099 participants were r and omized . Of these , 45 % were male , the mean age of all participants was 56 , and 1385 ( 66 % ) self-reported hypercholesterolemia . Follow-up information was obtained for 1945 ( 93 % ) . Participants completed a brief online question naire . Individuals assigned to intervention received immediate , fully automated , personally tailored advice ( based on current guidelines ) regarding the need for commencement of statin therapy , increased statin therapy in those already on treatment , and nondrug intervention strategies . Control group participants were directed to static Web pages providing general information about cholesterol management . Results The primary outcome was the proportion of participants that commenced or increased use of prescribed cholesterol-lowering therapy . Of the total 2099 r and omized participants , 304 ( 14 % ) met eligibility criteria for cholesterol-lowering therapy but were not prescribed treatment , and 254 ( 12 % ) were prescribed treatment but were not achieving the recommended target level . Treatment was commenced or increased in 64 ( 6.0 % ) of the 1062 intervention group participants and 79 ( 7.6 % ) of the 1037 control group participants ( % difference = -1.6 % , 95 % confidence interval [ CI ] -3.75 to 0.57 , P = .15 ) . No differences were found between the r and omized groups for the secondary outcomes of “ discussed treatment with a health professional ” ( % difference = -3.8 % , 95 % confidence interval [ CI ] -8.16 to 0.19 , P = .08 ) , “ had their cholesterol checked ” ( % difference = -1.5 % , 95 % CI -5.79 to 2.71 , P = .48 ) , “ had their blood pressure checked ” ( % difference = 1.4 % , 95 % CI -2.55 to 5.34 , P = .49 ) or made a lifestyle change ( P values between .49 and .96 ) . Conclusions Despite providing specific carefully tailored advice , this website had no detectable effect on cholesterol management strategies . This finding raises considerable uncertainty about the value of Internet-based tools providing tailored advice directly to consumers . Trial Registration NCT00220974 ; http:// clinical trials.gov/ct2/show/NCT00220974 ( Archived by WebCite at http://www.webcitation.org/5sdq63rrY",
"OBJECTIVE The aim of this study was to evaluate the impact of an integrated patient-specific electronic clinical reminder system on diabetes and coronary artery disease ( CAD ) care and to assess physician attitudes toward this reminder system . DESIGN We enrolled 194 primary care physicians caring for 4549 patients with diabetes and 2199 patients with CAD at 20 ambulatory clinics . Clinics were r and omized so that physicians received either evidence -based electronic reminders within their patients ' electronic medical record or usual care . There were five reminders for diabetes care and four reminders for CAD care . MEASUREMENTS The primary outcome was receipt of recommended care for diabetes and CAD . We created a summary outcome to assess the odds of increased compliance with overall diabetes care ( based on five measures ) and overall CAD care ( based on four measures ) . We surveyed physicians to assess attitudes toward the reminder system . RESULTS Baseline adherence rates to all quality measures were low . While electronic reminders increased the odds of recommended diabetes care ( odds ratio [ OR ] 1.30 , 95 % confidence interval [ CI ] 1.01 - 1.67 ) and CAD ( OR 1.25 , 95 % CI 1.01 - 1.55 ) , the impact of individual reminders was variable . A total of three of nine reminders effectively increased rates of recommended care for diabetes or CAD . The majority of physicians ( 76 % ) thought that reminders improved quality of care . CONCLUSION An integrated electronic reminder system result ed in variable improvement in care for diabetes and CAD . These improvements were often limited and quality gaps persist",
"OBJECTIVE To assess two physician learning interventions design ed to improve safety and quality of diabetes care delivered by primary care physicians ( PCPs ) . RESEARCH DESIGN AND METHODS This group r and omized clinical trial included 57 consenting PCPs and their 2,020 eligible adult patients with diabetes . Physicians were r and omized to no intervention ( group A ) , a simulated case-based physician learning intervention ( group B ) , or the same simulated case-based learning intervention with physician opinion leader feedback ( group C ) . Dependent variables included A1C values , LDL cholesterol values , pharmacotherapy intensification rates in patients not at clinical goals , and risky prescribing events . RESULTS Groups B and C had substantial reductions in risky prescribing of metformin in patients with renal impairment ( P = 0.03 ) . Compared with groups A and C , physicians in group B achieved slightly better glycemic control ( P = 0.04 ) , but physician intensification of oral glucose-lowering medications was not affected by interventions ( P = 0.41 ) . Lipid management improved over time ( P case-based learning intervention for physicians significantly reduced risky prescribing events and marginally improved glycemic control in actual patients . The addition of opinion leader feedback did not improve the learning intervention . Refinement and further development of this approach is warranted",
"Background Using the Internet may prove useful in providing nutrition counselling and social support for patients with chronic diseases . Objective We evaluated the impact of Web-based nutrition counselling and social support on social support measures , anthropometry , blood pressure , and serum cholesterol in patients at increased cardiovascular risk . Methods We conducted a r and omized controlled trial among patients with increased cardiovascular risk in Canadian family practice s. During 8 months , patients in the intervention group and control groups received usual care . Patients in the intervention group also had access to a Web-based nutrition counselling and social support tool ( Heartweb ) . Site use during the study was monitored . We measured social support , body mass index , waist/hip ratio , blood pressure , and cholesterol levels at baseline and at 4 and 8 months to assess the effectiveness of the intervention . Results We r and omized 146 patients into the Web-based intervention ( n=73 ) or the control group ( n=73 ) . Within the Web-based intervention group , Heartweb was used by only 33 % ( 24/73 ) of patients , with users being significantly younger than nonusers ( P=.03 ) . There were no statistically significant differences between the intervention group and the control group in changes in social support , anthropometry , blood pressure , and serum cholesterol levels . Conclusions Uptake of the Web-based intervention was low . This study showed no favourable effects of a Web-based nutrition counselling and social support intervention on social support , anthropometry , blood pressure , and serum cholesterol . Improvements in reach and frequency of site use are needed to increase the effectiveness of Web-based interventions",
"BACKGROUND Computerized decision support systems ( CDSSs ) linked with electronic medical records ( EMRs ) are promoted as an effective means of improving patient care . However , very few high- quality studies are set in routine , community-based clinical care , and no consistent evidence of an effect on patient outcomes has been found . METHODS A r and omized controlled trial among EMR-using primary care practice s in Ontario , Canada . Patients 55 years or older with previous vascular events , diabetes mellitus , hypertension , or hypercholesterolemia were r and omized to the Computerization of Medical Practice s for the Enhancement of Therapeutic Effectiveness ( COMPETE III ) CDSS intervention or to usual care . The intervention included personally tailored electronic vascular risk monitoring and treatment advice shared between the physician and patient , risk calculation , and a clinical re source . The primary outcome was a composite score of 8 recommended process outcomes at 1 year . Data collectors were blinded to group allocation . Analysis used the intention-to-treat principle with multiple imputation for missing data . RESULTS We r and omized and included in the analysis 1102 patients in 49 community-based physician practice s ( 53.4 % female ; mean age , 69.1 years ; 28.0 % with a previous vascular event ) . The intervention group ( 545 [ 49.5 % ] ) had a significantly greater improvement in mean process composite , with a difference of 4.70 ( P continuity of care ( 4.18 ; P ability to improve their vascular health ( 3.07 ; P -vascular events , clinical variables , and quality of life-were not improved . CONCLUSION Despite favorable review s and important improvements in the complex processes required to reduce vascular risk , clinical outcomes remain unchanged",
"OBJECTIVE —The Diabetes Care Protocol combines task delegation ( a practice nurse ) , computerized decision support , and feedback every 3 months . We studied the effect of the Diabetes Care Protocol on A1C and cardiovascular risk factors in type 2 diabetic patients in primary care . RESEARCH DESIGN AND METHODS —In a cluster r and omized trial , mean changes in cardiovascular risk factors between the intervention and control groups after 1 year were calculated by generalized linear models . RESULTS —Throughout the Netherl and s , 26 intervention practice s included 1,699 patients and 29 control practice s 1,692 patients . The difference in A1C change was not significant , whereas total cholesterol , LDL cholesterol , and blood pressure improved significantly more in the intervention group . The 10-year coronary heart disease risk estimate of the UK Prospect i ve Diabetes Study improved 1.4 % more in the intervention group . CONCLUSIONS —Delegation of routine diabetes care to a practice nurse combined with computerized decision support and feedback did not improve A1C but reduced cardiovascular risk in type 2 diabetes patients",
"CONTEXT Based on observational and interventional data for middle-aged cohorts ( aged 40 - 64 years ) , serum cholesterol level is known to be an established major risk factor for coronary heart disease ( CHD ) . However , findings for younger people are limited , and the value of detecting and treating hypercholesterolemia in younger adults is debated . OBJECTIVE To evaluate the long-term impact of unfavorable serum cholesterol levels on risk of death from CHD , cardiovascular disease ( CVD ) , and all causes . DESIGN , SETTING , AND PARTICIPANTS Three prospect i ve studies , from which were selected 3 cohorts of younger men with baseline serum cholesterol level measurements and no history of diabetes mellitus or myocardial infa rct ion . A total of 11,017 men aged 18 through 39 years screened in 1967 - 1973 for the Chicago Heart Association Detection Project in Industry ( CHA ) ; 1266 men aged 25 through 39 years examined in 1959 - 1963 in the Peoples Gas Company Study ( PG ) ; and 69,205 men aged 35 through 39 years screened in 1973 - 1975 for the Multiple Risk Factor Intervention Trial ( MRFIT ) . MAIN OUTCOME MEASURES Cause-specific mortality during 25 ( CHA ) , 34 ( PG ) , and 16 ( MRFIT ) years of follow-up ; mortality risks ; and estimated life expectancy in relation to baseline serum cholesterol levels . RESULTS Death due to CHD accounted for 26 % , 34 % , and 28 % of all deaths in the CHA , PG , and MRFIT cohorts , respectively ; and CVD death for 34 % , 42 % , and 39 % of deaths in the same cohorts , respectively . Men in all 3 cohorts with unfavorable serum cholesterol levels ( 200 - 239 mg/dL [ 5.17 - 6.18 mmol/L ] and > /=240 mg/dL [ > /=6.21 mmol/L ] ) had strong gradients of relative mortality risk . For men with serum cholesterol levels of 240 mg/dL or greater ( > /=6.21 mmol/L ) vs favorable levels ( CHD mortality risk was 2.15 to 3.63 times greater ; CVD disease mortality risk was 2.10 to 2.87 times greater ; and all-cause mortality was 1.31 to 1.49 times greater . Hypercholesterolemic men had age-adjusted absolute risk of CHD death of 59 per 1000 men in 25 years ( CHA cohort ) , 90 per 1000 men in 34 years ( PG cohort ) , and 15 per 1000 men in 16 years ( MRFIT cohort ) . Absolute excess risk was 43.6 per 1000 men ( CHA ) , 81.4 per 1000 men ( PG ) , and 12.1 per 1000 men ( MRFIT ) . Men with favorable baseline serum cholesterol levels had an estimated greater life expectancy of 3.8 to 8.7 years . CONCLUSIONS These results demonstrate a continuous , grade d relationship of serum cholesterol level to long-term risk of CHD , CVD , and all-cause mortality , substantial absolute risk and absolute excess risk of CHD and CVD death for younger men with elevated serum cholesterol levels , and longer estimated life expectancy for younger men with favorable serum cholesterol levels . JAMA . 2000;284:311 -",
"BACKGROUND Creative , cost-effective interventions to improve the quality of care of chronic illnesses are needed . This study was design ed to evaluate the impact of remote physician-pharmacist team-based care on cholesterol levels in patients with diabetes mellitus ( DM ) . METHODS This 2-year prospect i ve , cluster r and omized controlled trial was conducted within the Providence Primary Care Research Network in Oregon . Participants at least 18 years of age were identified by a diagnosis of DM . The intervention included remote physician-pharmacist team-based care focused on cholesterol management in DM . All clinicians in the study had access to the health information technology tool CareManager , which provided automated DM-related point-of-care prompts , a Web-based registry , and performance feedback with benchmarking . Study outcomes included the difference in low-density lipoprotein cholesterol ( LDL-C ) goal attainment , mean LDL-C , prescribed lipid-lowering therapy , and patient satisfaction between the intervention and control arms . RESULTS A total of 6963 patients with DM cared for by 68 physicians in 9 clinics were evaluated . Patients in the intervention arm were more likely to achieve their target LDL-C levels compared with controls ( 78 % vs 50 % ; P = .003 ) . The mean LDL-C level was 12 mg/dL lower in the intervention arm compared with the control arm ( P rate of LDL-C testing was significantly higher in the intervention arm compared with the control arm . Patients in the intervention arm were also 15 % more likely to receive a prescription for a lipid-lowering medication ( P = .008 ) . There was no significant difference in patient satisfaction between study arms ( P = .15 ) . CONCLUSION Remotely located physician-pharmacist team-based care result ed in significantly improved LDL-C levels and goal attainment among patients with DM",
"OBJECTIVE To test effects of a web-based decision support tool , the diabetes Disease Management Application ( DMA ) , developed to improve evidence -based management of type 2 diabetes . RESEARCH DESIGN AND METHODS We conducted a group r and omized controlled trial of 12 intervention and 14 control staff providers and 307 intervention and 291 control patients with type 2 diabetes in a hospital-based internal medicine clinic . Providers were r and omly assigned from May 1998 through April 1999 to have access to the DMA ( intervention ) or not to have access ( control ) . The DMA displays interactive patient-specific clinical data , treatment advice , and links to other web-based care re sources . We compared patients in the intervention and control groups for changes in processes and outcomes of care from the year preceding the study through the year of the study by intention-to-treat analysis . RESULTS The DMA was used for 42 % of scheduled patient visits . The number of HbA(1c ) tests obtained per year increased significantly in the intervention group ( + 0.3 tests/year ) compared with the control group ( -0.04 tests/year , P = 0.008 ) , as did the number of LDL cholesterol tests ( intervention , + 0.2 tests/year ; control , + 0.01 tests/year ; P = 0.02 ) and the proportions of patients undergoing at least one foot examination per year ( intervention , + 9.8 % ; control , -0.7 % ; P = 0.003 ) . Levels of HbA(1c ) decreased by 0.2 in the intervention group and increased by 0.1 in the control group ( P = 0.09 ) ; proportions of patients with LDL cholesterol levels < 130 mg/dl increased by 20.3 % in the intervention group and 10.5 % in the control group ( P = 0.5 ) . CONCLUSIONS Web-based patient-specific decision support has the potential to improve evidence -based parameters of diabetes care",
"BACKGROUND Physician adherence to National Cholesterol Education Program clinical practice guidelines has been poor . METHODS We recruited 68 primary care family and internal medicine practice s ; 66 were r and omly allocated to a study arm ; 5 practice s withdrew , result ing in 29 receiving the Third Adult Treatment Panel ( ATP III ) intervention and 32 receiving an alternative intervention focused on the Seventh Report of the Joint National Committee on the Prevention , Detection , Evaluation , and Treatment of High Blood Pressure ( JNC-7 ) . The ATP III providers received a personal digital assistant providing the Framingham risk scores and ATP III-recommended treatment . All practice s received copies of each clinical practice guideline , an introductory lecture , 1 performance feedback report , and 4 visits for intervention-specific academic detailing . Data were abstract ed at 61 practice s from r and om sample s of medical records of patients treated from June 1 , 2001 , through May 31 , 2003 ( baseline ) , and from May 1 , 2004 , through April 30 , 2006 ( follow-up ) . The proportion screened with subsequent appropriate decision making ( primary outcome ) was calculated . Generalized estimating equations were used to compare results by arm , accounting for clustering of patients within practice s. RESULTS We examined 5057 baseline and 3821 follow-up medical records . The screening rate for lipid levels increased from 43.6 % to 49.0 % ( ATP III practice s ) and from 40.1 % to 50.8 % ( control practice s ) ( net difference , -5.3 % [ P = .22 ] ) . Appropriate management of lipid levels decreased slightly ( 73.4 % to 72.3 % ) in ATP III practice s and more markedly ( 79.7 % to 68.9 % ) in control practice s. The net change in appropriate management favored the intervention ( + 9.7 % ; 95 % confidence interval [ CI ] , 2.8%-16.6 % [ P Appropriate drug prescription within 4 months decreased in both arms ( 38.8 % to 24.8 % in ATP III practice s and 45.3 % to 24.1 % in control practice s ; net change , + 7.2 % [ P = .37 ] ) Overtreatment declined from 6.6 % to 3.9 % in ATP III and rose from 4.2 % to 6.4 % in control practice s ( net change , -4.9 % [ P = .01 ] ) . CONCLUSIONS A multifactor intervention including personal digital assistant-based decision support may improve primary care physician adherence to the ATP III guidelines . Trial Registration clinical trials.gov Identifier : NCT00224848",
"Background Blood pressure , lipid , and glycemic control are essential for reducing cardiovascular disease ( CVD ) risk . Many health care systems have successfully shifted aspects of chronic disease management , including population -based outreach programs design ed to address CVD risk factor control , to non-physicians . The purpose of this study is to evaluate provision of new information to non-physician outreach teams on need for treatment intensification in patients with increased CVD risk . Methods Cluster r and omized trial ( July 1-December 31 , 2008 ) in Kaiser Permanente Northern California registry of members with diabetes mellitus , prior CVD diagnoses and /or chronic kidney disease who were high-priority for treatment intensification : blood pressure ≥ 140 mmHg systolic , LDL-cholesterol ≥ 130 mg/dl , or hemoglobin A1c ≥ 9 % ; adherent to current medications ; no recent treatment intensification ) . R and omization units were medical center-based outreach teams ( 4 intervention ; 4 control ) . For intervention teams , priority flags for intensification were added monthly to the registry data base with recommended next pharmacotherapeutic steps for each eligible patient . Control teams used the same data base without this information . Outcomes included 3-month rates of treatment intensification and risk factor levels during follow-up . Results Baseline risk factor control rates were high ( 82 - 90 % ) . In eligible patients , the intervention was associated with significantly greater 3-month intensification rates for blood pressure ( 34.1 vs. 30.6 % ) and LDL-cholesterol ( 28.0 vs 22.7 % ) , but not A1c . No effects on risk factors were observed at 3 months or 12 months follow-up . Intervention teams initiated outreach for only 45 - 47 % of high-priority patients , but also for 27 - 30 % of lower-priority patients . Teams reported difficulties adapting prior outreach strategies to incorporate the new information . Conclusions Information enhancement did not improve risk factor control compared to existing outreach strategies at control centers . Familiarity with prior , relatively successful strategies likely reduced uptake of the innovation and its potential for success at intervention centers . Trial registration Clinical Trials.gov Identifier",
"OBJECTIVE The study 's objective was to assess the effects of automated telephone outreach with speech recognition ( ATO-SR ) on diabetes-related testing . RESEARCH DESIGN AND METHODS We identified 1,200 health plan members who were overdue for diabetes-related testing and r and omly allocated 600 to ATO-SR and 600 to usual care ( no intervention ) . The intervention included three interactive calls encouraging recommended testing . The primary outcome was retinopathy testing , since this was the health plan 's principal goal . Tests for glycemia , hyperlipidemia , and nephropathy were secondary outcomes . RESULTS In total , 232 participants ( 39 % ) verbally responded to the calls . There was no difference between the intervention and the usual care groups in the primary outcome ( adjusted hazard ratio 0.93 [ 95 % CI 0.71–1.22 ] ) and no effect of the intervention on any of the secondary outcomes . CONCLUSIONS Fewer than 40 % of the patients r and omized to ATO-SR interacted verbally with the system . The intervention had no effect on the study 's outcomes",
"Aims We assessed whether a novel programme to evaluate/communicate predicted coronary heart disease ( CHD ) risk could lower patients ' predicted Framingham CHD risk vs. usual care . Methods The Risk Evaluation and Communication Health Outcomes and Utilization Trial was a prospect i ve , controlled , cluster-r and omised trial in nine European countries , among patients at moderate cardiovascular risk . Following baseline assessment s , physicians in the intervention group calculated patients ' predicted CHD risk and were instructed to advise patients according to a risk evaluation/communication programme . Usual care physicians did not calculate patients ' risk and provided usual care only . The primary end-point was Framingham 10-year CHD risk at 6 months with intervention vs. usual care . Results Of 1103 patients across 100 sites , 524 patients receiving intervention , and 461 receiving usual care , were analysed for efficacy . After 6 months , mean predicted risks were 12.5 % with intervention , and 13.7 % with usual care [ odds ratio = 0.896 ; p = 0.001 , adjusted for risk at baseline ( 17.2 % intervention ; 16.9 % usual care ) and other covariates ] . The proportion of patients achieving both blood pressure and low-density lipoprotein cholesterol targets was significantly higher with intervention ( 25.4 % ) than usual care ( 14.1 % ; p physician-implemented CHD risk evaluation/communication programme improved patients ' modifiable risk factor profile , and lowered predicted CHD risk compared with usual care . By combining this strategy with more intensive treatment to reduce residual modifiable risk , we believe that substantial improvements in cardiovascular disease prevention could be achieved in clinical practice",
"Background : Lipid-lowering treatment with statins has proven to be effective in reducing cardiovascular events and mortality . In daily practice , however , adherence to medication is often low and this compromises the therapeutic effect . The aim of this study was to assess the effectiveness of an electronic reminder device ( ERD ) with or without counseling to improve refill adherence and persistence for statin treatment in non-adherent patients . Methods : A multicenter , community pharmacy-based , r and omized controlled trial was conducted in 24 pharmacies in the Netherl and s among patients with pre-baseline refill adherence rates between 50 and 80 % . Eligible patients aged 65 years or older were r and omly assigned to 1 of 3 groups : ( 1 ) counseling with an ERD ( n = 134 ) , ( 2 ) ERD with a written instruction ( n = 131 ) , and a ( 3 ) control group that received the usual treatment ( n = 134 ) . Main outcome measure : refill adherence to statin treatment for a 360-day period after inclusion ( PDC360 ) . Patients with a refill rate ≥80 % were considered adherent . The effect among subgroups was also assessed . Results : There were no relevant differences at baseline . In the counseling with ERD group 54 of 130 eligible patients received the counseling with ERD . In the ERD group , 117 of 123 eligible patients received the ERD . The proportions of adherent patients in the counseling with ERD-group ( 69.2 % ) and in the ERD group ( 72.4 % ) were not higher than in the control group ( 64.8 % ) . Among women using statins for secondary prevention , more patients were adherent in the ERD group ( 86.1 % ) than in the control group ( 52.6 % ) ( p men using statins for secondary prevention the ERD was found to have no effect . Conclusion : In this r and omized controlled trial , no statistically significant improvement of refill adherence was found if an ERD was used with or without counseling . However , in a subgroup of women using statins for secondary prevention the ERD did improve adherence significantly",
"Background Efficacious strategies for the primary prevention of coronary heart disease ( CHD ) are underused , and , when used , have low adherence . Existing efforts to improve use and adherence to these efficacious strategies have been so intensive that they are impractical for clinical practice . Methods We conducted a r and omized trial of a CHD prevention intervention ( including a computerized decision aid and automated tailored adherence messages ) at one university general internal medicine practice . After obtaining informed consent and collecting baseline data , we r and omized patients ( men and women age 40 - 79 with no prior history of cardiovascular disease ) to either the intervention or usual care . We then saw them for two additional study visits over 3 months . For intervention participants , we administered the decision aid at the primary study visit ( 1 week after baseline visit ) and then mailed 3 tailored adherence reminders at 2 , 4 , and 6 weeks . We assessed our outcomes ( including the predicted likelihood of angina , myocardial infa rct ion , and CHD death over 10 years ( CHD risk ) and self-reported adherence ) between groups at 3 month follow-up . Data collection occurred from June 2007 through December 2009 . All study procedures were IRB approved . Results We r and omized 160 eligible patients ( 81 intervention ; 79 control ) and followed 96 % to study conclusion . Mean predicted CHD risk at baseline was 11.3 % . The intervention increased self-reported adherence to chosen risk reducing strategies by 25 percentage points ( 95 % CI 8 % to 42 % ) , with the biggest effect for aspirin . It also changed predicted CHD risk by -1.1 % ( 95 % CI -0.16 % to -2 % ) , with a larger effect in a pre-specified subgroup of high risk patients . Conclusion A computerized intervention that involves patients in CHD decision making and supports adherence to effective prevention strategies can improve adherence and reduce predicted CHD risk . Clinical trials registration number Clinical Trials.gov :",
"BACKGROUND Dyslipidemia remains underdiagnosed and undertreated in patients with coronary artery disease . The Computer-based Clinical Decision Support System provides an opportunity t close these gaps . OBJECTIVES To study the impact of computerized intervention on secondary prevention of CAD . METHODS The CDSS was programmed to automatically detect patients with CAD and to evaluate the availability of an up date d lipoprotein profile and treatment with lipid-lowering drugs . The program produced automatic computer-generated monitoring and treatment recommendations . Adjusted primary clinics were r and omly assigned to intervention ( n=56 ) or st and ard care arms ( n=56 ) . Reminders were mailed to the primary medical teams in the intervention arm every 4 months updating them with current lipid levels and recommendations for further treatment . Compliance and lipid levels were monitored . The study group comprised all patients with CAD who were alive at least 3 months after hospitalization . RESULTS Follow-up was available for 7448 patients ( median 19.8 months , range 6 - 36 months ) . Overall , 51.7 % of patients were adequately screened , and 55.7 % of patients were compliant with treatment to lower lipid level . In patients with initial low density lipoprotein > 120 mg/dl , a significant decrease in LDL levels was observed in both arms , but was more pronounced in the intervention arm : 121.9 + /- 34.2 vs. 124.3 + /- 34.6 mg/dl ( P cardiac rehospitalizations was documented in patients who were adequately treated with lipid-lowering drugs , 37 % vs. 40.9 % ( P CAD patients often do not adhere to clinical guidelines , presenting a major obstacle to implementing effective secondary prevention . Our automatic computerized reminders system substantially facilitates adherence to guidelines and supports wide-range implementation",
"OBJECTIVE To assess the effect of a specialist telemedicine intervention for improving diabetes care using the chronic care model ( CCM ) . PARTICIPANTS AND METHODS As part of the CCM , 97 primary care physicians at 6 primary care practice s in Rochester , MN , referred 639 patients to an on-site diabetes educator between July 1 , 2001 , and December 31 , 2003 . On first referral , physicians were central ly r and omized to receive a telemedicine intervention ( specialty advice and evidence -based messages regarding medication management for cardiovascular risk ) or no intervention , keeping outcome assessors and data analysts blinded to group assignment . After each subsequent clinical encounter , endocrinologists review ed an abstract from the patient 's electronic medical record and provided management recommendations and supporting evidence to intervention physicians via e-mail . Control physicians received e-mail with periodic generic information about cardiovascular risk reduction in diabetes . Outcome measures included diabetes care processes ( diabetes test completion ) , outcomes ( metabolic and cardiovascular risk factors , estimated coronary artery disease risk ) , and patient costs ( payer perspective ) . RESULTS During the intervention , 951 ( 70 % ) of the 1361 endocrinology review s detected performance gaps and result ed in a message ; primary care physicians reported using 49 % of messages in patient care . With a mean of 21 months ' follow-up , the intervention , compared with control , did not significantly enhance metabolic outcomes or reduce estimated risk of coronary artery disease ( adjusted mean difference , -1 % ; 95 % confidence interval , -19 % to 17 % ) . The intervention group incurred lower costs ( P=.02 ) but not in diabetes-related costs . CONCLUSION Specialty telemedicine did not significantly enhance the value of CCM in primary care",
"PURPOSE We wanted to determine whether an intervention based on patient activation and a physician decision support tool was more effective than usual care for improving adherence to National Cholesterol Education Program guidelines . METHODS A 1-year cluster r and omized controlled trial was performed using 30 primary care practice s ( 4,105 patients ) in southeastern New Engl and . The main outcome was the percentage of patients screened for hyperlipidemia and treated to their low-density lipoprotein ( LDL ) and non – high-density lipoprotein ( HDL ) cholesterol goals . RESULTS After 1 year of intervention , both r and omized practice groups improved screening ( 89 % screened ) , and 74 % of patients in both groups were at their LDL and non-HDL cholesterol goals ( P screening or percentage of patients who achieved LDL and non-HDL cholesterol goals . Post hoc analysis showed practice s who made high use of the patient activation kiosk were more likely to have patients screened ( odds ratio [ OR ] = 2.54 ; 95 % confidence interval [ CI ] , 1.97–3.27 ) compared with those who made infrequent or no use . Additionally , physicians who made high use of decision support tools were more likely to have their patients at their LDL cholesterol goals ( OR = 1.27 ; 95 % CI , 1.07–1.50 ) and non-HDL goals ( OR = 1.23 ; 95 % CI , 1.04–1.46 ) than low-use or no-use physicians . CONCLUSION This study showed None results with the intent-to-treat analysis regarding the benefits of a patient activation and a decision support tool in improving cholesterol management in primary care practice s. Post hoc analysis showed a potential benefit in practice s that used the e-health tools more frequently in screening and management of dyslipidemia . Further research on how to incorporate and increase adoption of user-friendly , patient-centered e-health tools to improve screening and management of chronic diseases and their risk factors is warranted",
"OBJECTIVE : Suboptimal treatment of hyperlipidemia in patients with coronary artery disease ( CAD ) is well documented . We report the impact of a computer-assisted physician-directed intervention to improve secondary prevention of hyperlipidemia . DESIGN AND SETTING : Two hundred thirty-five patients under the care of 14 primary care physicians in an academically affiliated practice with an electronic health record were enrolled in this proof-of-concept physician-blinded r and omized , controlled trial . Each patient with CAD or risk equivalent above National Cholesterol Education Program-recommended low-density lipoprotein ( LDL ) treatment goal for greater than 6 months was r and omized , stratified by physician and baseline LDL . Physicians received a single e-mail per intervention patient . E-mails were visit independent , provided decision support , and facilitated “ one-click ” order writing . MEASUREMENTS : The primary outcomes were changes in hyperlipidemia prescriptions , time to prescription change , and changes in LDL levels . The time spent using the system was assessed among intervention patients . RESULTS : A greater proportion of intervention patients had prescription changes at 1 month ( 15.3 % vs 2 % , P=.001 ) and 1 year ( 24.6 % vs 17.1 % , P=.14 ) . The median interval to first medication adjustment occurred earlier among intervention patients ( 0 vs 7.1 months , P=.005 ) . Among patients with baseline LDLs > 130 mg/dL , the first postintervention LDLs were substantially lower in the intervention group ( 119.0 vs 138.0 mg/dL , P=.04 ) . Physician processing time was under 60 seconds per e-mail . CONCLUSION : A visit-independent disease management tool result ed in significant improvement in secondary prevention of hyperlipidemia at 1-month postintervention and showed a trend toward improvement at 1 year",
"Background : Diabetes mellitus is a complex disease with serious complications . Electronic decision support , providing information that is shared and discussed by both patient and physician , encourages timely interventions and may improve the management of this chronic disease . However , it has rarely been tested in community-based primary care . Methods : In this pragmatic r and omized trial , we r and omly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care . The intervention involved shared access by the primary care provider and the patient to a Web-based , colour-coded diabetes tracker , which provided sequential monitoring values for 13 diabetes risk factors , their respective targets and brief , prioritized messages of advice . The primary outcome measure was a process composite score . Secondary outcomes included clinical composite scores , quality of life , continuity of care and usability . The outcome assessors were blinded to each patient ’s intervention status . Results : We recruited sequentially 46 primary care providers and then 511 of their patients ( mean age 60.7 [ st and ard deviation 12.5 ] years ) . Mean follow-up was 5.9 months . The process composite score was significantly better for patients in the intervention group than for control patients ( difference 1.27 , 95 % confidence interval [ CI ] 0.79–1.75 , p clinical composite score also had significantly more variables with improvement for the intervention group ( 0.59 , 95 % CI 0.09–1.10 , p = 0.02 ) , including significantly greater declines in blood pressure ( −3.95 mm Hg systolic and −2.38 mm Hg diastolic ) and glycated hemoglobin ( −0.2 % ) . Patients in the intervention group reported greater satisfaction with their diabetes care . Interpretation : A shared electronic decision-support system to support the primary care of diabetes improved the process of care and some clinical markers of the quality of diabetes care . ( Clinical Trials.gov trial register no. NCT00813085 .",
" A total of 175 patients with Types 1 and 2 diabetes in primary care and university hospital outpatient departments were r and omized into a study group ( n = 101 ) or usual care ( n = 74 ) . The study group used an e-health application with a diabetes management system and a home care link . Usual care did not involve e-health , i.e. the patients made regular general practitioner visits about every three months . After 12 months HbA1c decreased significantly in both groups of patients . The differences were small , but HbA1c was significantly lower in the study group than the controls . Diastolic blood pressure , fasting plasma glucose , serum total cholesterol , serum LDL-cholesterol and serum triglycerides were significantly lower in the study than in the control group . This was achieved with fewer visits by study patients to doctors and nurses . Use of e-health in diabetes care for 12 months was able to provide equivalent diabetic control to usual care , and improved cardiovascular risk factors",
"BACKGROUND The emergence of the World Wide Web in the last decade has made it feasible for the Internet to be a vehicle for chronic disease management . METHODS A r and omized controlled trial ( n = 62 ) testing the effects of a 6-month web-based intervention plus usual care , compared with usual care alone , among adults 60 years of age and older with diabetes . The outcomes were hemoglobin A1c ( HbA1c ) , blood pressure , weight , cholesterol , and high-density lipoprotein ( HDL ) levels . RESULTS A multivariate analysis of covariance controlling for all baseline outcome variables , age , gender , and number of years with diabetes showed significant ( P = 0.001 ) reductions in HbA1c , weight , and cholesterol level and significant improvement in HDL levels in the intervention versus the control group . CONCLUSIONS Findings show a web-based intervention was effective in improving HbA1c , weight , cholesterol , and HDL levels at a 6-month follow-up . Future research is needed to investigate the long-term effectiveness of web-based interventions",
"BACKGROUND Web-based personal health records ( PHRs ) have been advocated as a means to improve type 2 diabetes mellitus ( DM ) care . However , few Web-based systems are linked directly to the electronic medical record ( EMR ) used by physicians . METHODS We r and omized 11 primary care practice s. Intervention practice s received access to a DM-specific PHR that imported clinical and medications data , provided patient-tailored decision support , and enabled the patient to author a \" Diabetes Care Plan \" for electronic su bmi ssion to their physician prior to upcoming appointments . Active control practice s received a PHR to up date and su bmi t family history and health maintenance information . All patients attending these practice s were encouraged to sign up for online access . RESULTS We enrolled 244 patients with DM ( 37 % of the eligible population with registered online access , 4 % of the overall population of patients with DM ) . Study participants were younger ( mean age , 56.1 years vs 60.3 years ; P ( median income , $ 53,784 vs $ 49,713 ; P baseline glycemic control compared with non participants . More patients in the intervention arm had their DM treatment regimens adjusted ( 53 % vs 15 % ; P DM-related medication adjustment . Low rates of online patient account registration and good baseline control among participants limited the intervention 's impact on overall risk factor control . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00251875",
"BACKGROUND Despite increasing evidence that treating dyslipidemia reduces cardiovascular events , many patients do not achieve recommended lipid targets . METHODS To determine whether showing physicians and patients the patient 's calculated coronary risk can improve the effectiveness of treating dyslipidemia in a primary care setting , patients were r and omized to receive usual care or ongoing feedback regarding their calculated coronary risk and the change in this risk after lifestyle changes , pharmacotherapy , or both to treat dyslipidemia . Outcomes , based on intention-to-treat analysis , included changes in blood lipid levels , coronary risk , and the frequency of reaching lipid targets . RESULTS Two hundred thirty primary care physicians enrolled 3,053 patients . After 12 months of follow-up , 2,687 patients ( 88.0 % ) remained in the study . After adjustment for baseline lipid values , significantly greater mean reductions in low-density lipoprotein cholesterol levels and the total cholesterol to high-density lipoprotein cholesterol ratio were observed in patients receiving risk profiles ( 51.2 mg/dL [ to convert to millimoles per liter , multiply by 0.0259 ] and 1.5 , respectively ) vs usual care ( 48.0 mg/dL and 1.3 , respectively ) , but the differences were small ( -3.3 mg/dL ; 95 % confidence interval [ CI ] , -5.4 to -1.1 mg/dL ; and -0.1 ; 95 % CI , -0.2 to -0.1 , respectively ) . Patients in the risk profile group were also more likely to reach lipid targets ( odds ratio , 1.26 ; 95 % CI , 1.07 to 1.48 ) . A significant dose-response effect was also noted when the impact of the risk profile was stronger in those with worse profiles . CONCLUSIONS Discussing coronary risk with the patient is associated with a small but measurable improvement in the efficacy of lipid therapy . The value of incorporating risk assessment in preventive care should be further evaluated",
"BACKGROUND : Electronic information systems have been proposed as one means to reduce medical errors of commission ( doing the wrong thing ) and omission ( not providing indicated care ) . OBJECTIVE : To assess the effects of computer-based cardiac care suggestions . DESIGN : A r and omized , controlled trial targeting primary care physicians and pharmacists . SUBJECTS : A total of 706 out patients with heart failure and /or ischemic heart disease . INTERVENTIONS : Evidence -based cardiac care suggestions , approved by a panel of local cardiologists and general internists , were displayed to physicians and pharmacists as they cared for enrolled patients . MEASUREMENTS : Adherence with the care suggestions , generic and condition-specific quality of life , acute exacerbations of their cardiac disease , medication compliance , health care costs , satisfaction with care , and physicians ’ attitudes toward guidelines . RESULTS : Subjects were followed for 1 year during which they made 3,419 primary care visits and were eligible for 2,609 separate cardiac care suggestions . The intervention had no effect on physicians ’ adherence to the care suggestions ( 23 % for intervention patients vs 22 % for controls ) . There were no intervention-control differences in quality of life , medication compliance , health care utilization , costs , or satisfaction with care . Physicians viewed guidelines as providing helpful information but constraining their practice and not helpful in making decisions for individual patients . CONCLUSIONS : Care suggestions generated by a sophisticated electronic medical record system failed to improve adherence to accepted practice guidelines or outcomes for patients with heart disease . Future studies must weigh the benefits and costs of different ( and perhaps more Draconian ) methods of affecting clinician behavior",
"Discrepancies between clinical guidelines and clinical practice call for practical implementation strategies . This study evaluates the implementation of clinical guidelines for hypertension in general practice with a specific computer-based clinical decision support system ( CDSS ) as part of the intervention . We carried out a r and omized study of general practice health centres in Sør- and Nord-Trøndelag counties in Norway ( population 380000 ) . A total of 17 health centres were included , with 24 doctors and 984 patients in the intervention group . Data from 887 patients was used in the analyses . There were 12 health centres with 29 doctors and 1255 patients in the control group . Data from 1127 control patients was used in the analyses . The main outcome measures were doctor 's behaviour , measured by adherence to registration of recommended variables in the Norwegian clinical guidelines for hypertension . The aim of the intervention was to lower the fractions of patients without registration s. However , there were no clinical ly significant differences between the intervention group and the control group for fractions of patients without registration of blood pressure ( intervention group 14.3 % , control group 14.2 % ) or serum cholesterol ( 62.3 % vs. 56.8 % ) during 12 months , nor , during 18 months , for fractions of patients without a registration of cigarette smoking ( 82.9 % vs. 87.1 % ) , cardiovascular inheritance ( 79.5 % vs. 73.4 % ) and body mass index ( 81.5 % vs. 89.2 % ) . One or several variables necessary for calculation of risk score for myocardial infa rct ion were missing in 91.7 % of patients in the intervention group and 91.9 % of patients in the control group . Large centre variations were shown for all variables . Implementation of clinical guidelines in the treatment of hypertensive patients in general practice , by means of a CDSS and several procedures for implementation did not result in clinical ly significant changes in the doctors ' behaviour . Of importance are both the lack of user-friendliness of the specific CDSS and problems in performing time-consuming multidimensional procedures",
"PURPOSE We wanted to assess the impact of an electronic health record – based diabetes clinical decision support system on control of hemoglobin A1c ( glycated hemoglobin ) , blood pressure , and low-density lipoprotein ( LDL ) cholesterol levels in adults with diabetes . METHODS We conducted a clinic-r and omized trial conducted from October 2006 to May 2007 in Minnesota . Included were 11 clinics with 41 consenting primary care physicians and the physicians ’ 2,556 patients with diabetes . Patients were r and omized either to receive or not to receive an electronic health record (EHR)–based clinical decision support system design ed to improve care for those patients whose hemoglobin A1c , blood pressure , or LDL cholesterol levels were higher than goal at any office visit . Analysis used general and generalized linear mixed models with repeated time measurements to accommo date the nested data structure . RESULTS The intervention group physicians used the EHR-based decision support system at 62.6 % of all office visits made by adults with diabetes . The intervention group diabetes patients had significantly better hemoglobin A1c ( intervention effect −0.26 % ; 95 % confidence interval , −0.06 % to −0.47 % ; P=.01 ) , and better maintenance of systolic blood pressure control ( 80.2 % vs 75.1 % , P=.03 ) and borderline better maintenance of diastolic blood pressure control ( 85.6 % vs 81.7 % , P = .07 ) , but not improved low-density lipoprotein cholesterol levels ( P = .62 ) than patients of physicians r and omized to the control arm of the study . Among intervention group physicians , 94 % were satisfied or very satisfied with the intervention , and moderate use of the support system persisted for more than 1 year after feedback and incentives to encourage its use were discontinued . CONCLUSIONS EHR-based diabetes clinical decision support significantly improved glucose control and some aspects of blood pressure control in adults with type 2 diabetes"
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411735d4-06ff-11f0-808a-c43d1ab1c353
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Background Resveratrol as a polyphenolic compound might be able to reduce inflammatory mediators . Change in inflammatory state is identified by the measurement of inflammatory mediators such as interleukin-6 ( IL-6 ) , tumor necrosis factor-alpha ( TNF-α ) , and C-reactive protein ( CRP ) . The objective of this study is to conduct a systematic review and meta- analysis on r and omized controlled trials that assessed the effect of resveratrol on concentration of serum inflammatory mediators . MethodS ystematic search was performed up to October 2017 using ISI web of science , PubMed , Scopus , EMBASE , and Google scholar . Weighted mean difference was estimated either by subtracting baseline values from post-intervention value or as the post-intervention values . Fixed effect model was applied to analyze data where heterogeneity was 15 trials , involving 658 adults aged 18–75 years . Resveratrol significantly reduced serum CRP levels ( WMD = −0.54 ; 95 % CI : −0.78 , −0.30 ; I2 = 77.7 % ; P no significant effect on serum IL-6 ( WMD = −0.06 ; 95 % CI : −0.27 , 0.14 ; I2 = 62.0 % ; P = 0.005 ) and TNF-α levels ( WMD = −0.20 ; 95 % CI : −0.55 , 0.16 ; I2 = 87.2 % ; P ) . Resveratrol intake reduced TNF-α in young subjects ( WMD = −0.34 ; 95 % CI : −0.57 , −0.12 ; I2 = 60.5 % ; P = 0.038 ) and obese individuals ( WMD = −1.52 ; 95 % CI : −2.87 , −0.16 ; I2 = 74.1 % ; P = 0.004 ) . Conclusion The analysis indicated possible decreasing effect of resveratrol on CRP , but it might not be able to change IL-6 and TNF-α concentrations . More studies , separately on males and females with obesity , and varied age , are necessary
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"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",
"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 : 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",
"Objective . The effect of a proprietary formulation of trans-resveratrol ( t-RSV ) on manifestations of diabetic foot syndrome ( DFS ) was studied in type 2 diabetic patients with newly diagnosed diabetic foot ulcers . Method . Placebo-controlled , examiner-blinded , parallel-group r and omized controlled pilot clinical trial ( ACTRN Clinical Trial Registry number 12610000629033 ) involving 24 patients with DFS ( 15 males and 9 females , average age of 56.4 ± 9.1 years ) divided into the placebo and RSV-treatment groups was performed . 50 mg of t-RSV or placebo capsules was given to each patient twice a day over a 60-day time period . Results . Reduction in the parameters reflecting diabetic ulcer size was more profound in the RSV group as compared to placebo . RSV-treated patients also had a marginally improved performance in the foot pressure test . A statistically significant decline in the plasma fibrinogen level , but not CRP , was also found in the RSV-treated patients . Some improvement in the plasma lipid profile and fasting glucose levels were not related to RSV-treatment , since they have been seen on both the RSV and placebo groups , revealing the effectiveness of medical supervision and education in the newly diagnosed patients with DFS . Conclusion . t-RSV supplementation promotes reduction of the foot ulcer size and reduces plasma fibrinogen level in type 2 diabetic patients",
"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",
"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",
"BACKGROUND & AIMS Nonalcoholic fatty liver disease ( NAFLD ) , characterized by accumulation of hepatic triglycerides ( steatosis ) , is associated with abdominal obesity , insulin resistance , and inflammation . Although weight loss via calorie restriction reduces features of NAFLD , there is no pharmacologic therapy . Resveratrol is a polyphenol that prevents high-energy diet-induced steatosis and insulin resistance in animals by up-regulating pathways that regulate energy metabolism . We performed a placebo-controlled trial to assess the effects of resveratrol in patients with NAFLD . METHODS Overweight or obese men diagnosed with NAFLD were recruited from hepatology outpatient clinics in Brisbane , Australia from 2011 through 2012 . They were r and omly assigned to groups given 3000 mg resveratrol ( n = 10 ) or placebo ( n = 10 ) daily for 8 weeks . Outcomes included insulin resistance ( assessed by the euglycemic-hyperinsulinemic clamp ) , hepatic steatosis , and abdominal fat distribution ( assessed by magnetic resonance spectroscopy and imaging ) . Plasma markers of inflammation , as well as metabolic , hepatic , and antioxidant function , were measured ; transcription of target genes was measured in peripheral blood mononuclear cells . Resveratrol pharmacokinetics and safety were assessed . RESULTS Eight-week administration of resveratrol did not reduce insulin resistance , steatosis , or abdominal fat distribution when compared with baseline . No change was observed in plasma lipids or antioxidant activity . Levels of alanine and aspartate aminotransferases increased significantly among patients in the resveratrol group until week 6 when compared with the placebo group . Resveratrol did not significantly alter transcription of NQO1 , PTP1B , IL6 , or HO1 in peripheral blood mononuclear cells . Resveratrol was well-tolerated . CONCLUSIONS Eight weeks administration of resveratrol did not significantly improve any features of NAFLD , compared with placebo , but it increased hepatic stress , based on observed increases in levels of liver enzymes . Further studies are needed to determine whether agents that are purported to mimic calorie restriction , such as resveratrol , are safe and effective for complications of obesity . Clinical trials registration no : ACTRN12612001135808",
"Abstract Herbal medicines with high amounts of phytochemicals have been shown to have beneficial effects on blood pressure ( BP ) , endothelial function and anthropometric measures . This study aim ed to determine the effect of herbal treatment on BP , endothelial function and anthropometric measures in patients with type 2 diabetes mellitus ( T2DM ) . This clinical trial included 204 T2DM patients r and omly assigned to four intervention groups receiving 3 g cinnamon , 3 g cardamom , 1 g saffron or 3 g ginger with three glasses of black tea , and one control group consuming only three glasses of tea without any herbals , for 8 weeks . Intercellular adhesion molecule-1 ( ICAM-1 ) , systolic and diastolic BP and anthropometric measures were collected at baseline and after 8 weeks . No significant difference was found between various medicinal plants in terms of influencing BP , serum soluble (s)ICAM-1 concentrations and anthropometric measures . However , in within-group comparison saffron and ginger intakes significantly reduced sICAM-1 concentrations ( 340.9 ± 14.4 vs 339.69 ± 14.4 ng/ml , p = 0.01 , and 391.78 ± 16.0 vs 390.97 ± 15.8 ng/ml , p = 0.009 , respectively ) and ginger intake affected systolic BP ( 143.06 ± 0.2 vs 142.07 ± 0.2 mmHg , p = 0.02 ) . Although administration of these herbal medicines as supplementary remedies could affect BP and sICAM-1 concentrations , there was no significant difference between the plants in terms of influencing anthropometric measures , BP and endothelial function ",
"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",
"PURPOSE The purpose of this study was to determine the plasma metabolic response and certain indicators of oxidative stress ( antioxidant system and oxidative stress biomarkers ) in plasma and erythrocytes of Brazilian military firefighters supplemented or not with resveratrol ( RES ) for 90 days ( 100 mg/day ) . The analyses were performed before and after a typical physical fitness test ( FT ) used to induce oxidative stress . METHODS / RESULTS In this placebo-controlled double-blinded study , we observed that RES supplementation did not present hepatic consequences compared with the placebo group following analysis of AST , ALT and GGT plasma activities . Plasma glucose and triglycerides levels were increased after the FT in firefighters supplemented with RES but were not elevated at baseline . Neither total nor cholesterol fractions were modified by RES supplementation . CK levels were increased after the firefighters performed the FT ; however , no differences were determined between the placebo and RES groups . Ferric-reducing ability of plasma as well as uric acid was increased after the FT , but was not modified by RES supplementation . Plasma oxidative stress biomarkers , such as thiol content , 8-isoprostane and 8OHdG , showed no modifications , while IL-6 and TNF-α were decreased in the RES group after the FT . Among antioxidant enzyme activities determined in erythrocytes from the firefighters , only GPx activity was reduced by RES supplementation both before and after the FT . CONCLUSION In summary , the most pronounced effect of RES supplementation is its anti-inflammatory effect , which reduced IL-6 and TNF-α level . The FT applied to Brazilian military firefighters was not sufficient to challenge the antioxidant defense systems , and , therefore , 100 mg of RES for three months did not induce significant effects"
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Objective : A systematic review and meta- analysis of r and omized controlled trials ( RCTs ) were conducted to assess the benefits and harms of vitamin D supplementation for attention-deficit/hyperactivity disorder ( ADHD ) patients . Methods : We followed the st and ard method ological procedures of the Cochrane H and book for Systematic Review s of Intervention . PubMed , Embase , the Cochrane Central Register of Controlled Trials , Science and Conference Proceedings Citation Index-Social Science and Humanities ( Web of Science ) , ClincalTrials.gov , and World Health Organization 's International Clinical Trials Registry Platform were search ed for RCTs in January 2019 . Independently , two authors ( J.G. , T.X. ) extracted data , assessed the risk of bias , combined the data , and grade d evidence quality using the Grading of Recommendations Assessment , Development , and Evaluation approach . Our primary outcomes were assessed through rating scales of ADHD severity . Secondary outcomes measured were the possible adverse effects of vitamin D supplementation and vitamin D status after supplementation for ADHD . Results : We included four RCTs with 256 children addressing vitamin D supplementation as adjunctive therapy to methylpheni date on ADHD symptoms . Vitamin D supplementation demonstrated a small but statistically significant improvement in ADHD total scores , inattention scores , hyperactivity scores , and behavior scores . The improvement was likely limited due to the low to very low quality of evidence in the literature . There was no statistically significant improvement in oppositional scores . Reported adverse events in the vitamin D group were mild and not significantly different from the control group . Vitamin D supplementation increased serum vitamin D levels and the ratio of patients with sufficient vitamin D levels . Conclusions : Vitamin D supplementation as adjunctive therapy to methylpheni date appeared to reduce ADHD symptoms without serious adverse events , associated with improved vitamin D status . However , considering the generally low strength of evidence , well- design ed RCTs are needed to determine the efficacy and safety of vitamin D supplementation for both children and adults with ADHD , especially in the setting of a combination of vitamin D and other ADHD treatments
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"OBJECTIVE To evaluate the effects of medications used in the treatment of adults with attention-deficit/hyperactivity disorder ( ADHD ) on blood pressure and pulse . METHOD Subjects were those with DSM-III-R-/DSM-IV-diagnosed ADHD enrolled in placebo-controlled studies of 5 different medications for ADHD . Cardiovascular data from these studies of both stimulants ( methylpheni date , amphetamine compounds , pemoline ) and nonstimulants ( bupropion , desipramine ) were reanalyzed for baseline-to-endpoint active-treatment or placebo effects on blood pressure and heart rate . RESULTS There were 125 subjects with a mean + /- SD age of 39 + /- 9 years . In general , active drug treatment for ADHD compared to baseline was associated with several statistically significant changes in systolic blood pressure ( bupropion : + 5.9 mm Hg , p : + 5.4 mm Hg , p diastolic blood pressure ( desipramine : + 7.1 mm Hg , p heart rate ( bupropion : + 6.9 mm Hg , p amphetamine : + 7.3 mm Hg , p methylpheni date : + 4.5 mm Hg , p systolic or diastolic hypertension ( blood pressure > or = 140/90 ) were recorded in 8 % ( 7/89 ) of placebo-treated subjects and 10 % ( 9/89 ) of subjects receiving active medication , regardless of the class ( stimulant , nonstimulant ) . CONCLUSION Both stimulant and nonstimulant catecholaminergic medications used in adults with ADHD are associated with minor , but statistically significant , changes in heart rate and blood pressure that were often observed in those receiving placebo . Given the minor pressor and chronotropic effect of these medications , adults with ADHD should have their blood pressure and heart rate checked at baseline and periodically during treatment",
"Background Higher serum concentrations of 25-hydroxyvitamin D ( 25(OH)D ) , an indicator of vitamin D synthesis and intake , have been associated with better mental health and cognitive function . Concentrations of 1,25-dihydroxyvitamin D3 ( the active vitamin D3 metabolite ) have been associated with openness and extrovert behaviour , but 25(OH)D concentrations have not been associated with behavioural problems in humans . Methods We investigated the prospect i ve association between the different forms of 25(OH)D - 25(OH)D3 and 25(OH)D2– and childhood behavioural problems in Avon Longitudinal Study of Parents and Children ( ALSPAC ) . Serum 25(OH)D3 and 25(OH)D2 concentrations were assessed at mean age 9.9 years . Incident behavioural problems were assessed with Strengths and Difficulties Question naire ( SDQ ; emotional symptoms , conduct problems , hyperactivity-inattention problems , peer relationship problems and pro-social behaviour subscales and total difficulties score ) at mean age 11.7 . Sample sizes varied between 2413 - 2666 depending on the outcome . Results Higher 25(OH)D3 concentrations were weakly associated with lower risk of prosocial problems ( fully adjusted odds ratio : OR ( 95 % confidence interval : CI ) 0.85 ( 0.74 , 0.98 ) ) . Serum 25(OH)D3 or 25(OH)D2 concentrations were not associated with other subscales of SDQ or total difficulties score after adjusting for concfounders and other measured analytes related to vitamin D. Conclusions Our findings do not support the hypothesis that 25-hydroxyvitamin D status in childhood has important influences on behavioural traits in humans",
"Background : Vitamin D status during prenatal brain development may influence risk of attention deficit and hyperactivity disorder ( ADHD ) symptoms in childhood . However , there are no prospect i ve studies addressing this hypothesis . We aim ed to examine whether maternal vitamin D status in pregnancy is associated with risk of ADHD-like symptoms in offspring . Methods : We conducted a prospect i ve study analyzing data from 1,650 mother – child pairs from five birth cohorts embedded in the INMA Project ( Spain , 1997–2008 ) . Maternal vitamin D status in pregnancy was estimated by measuring plasma concentration of 25-hydroxyvitamin D3 [ 25(OH)D3 ] at 13 weeks of gestation . Children were assessed by teachers for ADHD-like symptoms at ages 4–5 years using the Diagnostic and Statistical Manual of Mental Disorders ADHD form list . Results : After adjustment , the number of total ADHD-like symptoms in children decreased by 11 % per 10 ng/ml increment of maternal 25(OH)D3 concentration ( incidence rate ratio [ IRR ] = 0.89 ; 95 % confidence interval [ CI ] = 0.80 , 0.98 ) . Similarly , the number of symptoms in the ADHD subscales decreased in relation to higher maternal 25(OH)D3 concentration ( IRR per 10 ng/ml increment = 0.89 ; 95 % CI = 0.79 , 0.99 for the inattention scale ; and IRR = 0.88 ; 95 % CI = 0.78 , 0.99 for the hyperactivity – impulsivity scale ) . Using diagnostic criteria , we found an association of increasing maternal 25(OH)D3 with a lower risk of ADHD DSM-IV ( relative risk ratio per 10 ng/ml increment = 0.87 ; 95 % CI = 0.72 , 1.06 ) and ICD-10 hyperkinetic disorder ( relative risk ratio = 0.72 ; 95 % CI = 0.49 , 1.04 ) in children . Conclusion : Higher maternal circulating levels of 25(OH)D3 in pregnancy are associated with lower risk of developing ADHD-like symptoms in childhood",
"BACKGROUND The few controlled studies of methylpheni date ( MPH ) in adults with attention deficit/hyperactivity disorder ( ADHD ) have reported equivocal results . A previous , pilot study by our group suggested that these results were due to inadequate dosing . METHOD We conducted a r and omized , 6-week , placebo-controlled , parallel study of MPH in 146 adult patients with DSM-IV ADHD using st and ardized instruments for diagnosis , separate assessment s of ADHD , depressive and anxiety symptoms , and a robust average oral daily dose of 1.1 mg/kg/day . RESULTS We found a marked therapeutic response for the MPH treatment of ADHD symptoms that exceeded the placebo response ( 76 % vs. 19 % ) . Treatment was safe and well tolerated . Response to MPH was independent of socioeconomic status , gender , and lifetime history of psychiatric comorbidity . CONCLUSIONS These results confirm that robust doses of MPH are effective in the treatment of adult ADHD",
"Objective : Previous research on the developmental course of attention-deficit/hyperactivity disorder ( ADHD ) is limited by biased clinic-referred sample s and other method ological problems . Thus , questions about adult academic outcomes associated with childhood ADHD remain unanswered . Thus , the objective of this study was to describe academic outcomes in adulthood among incident cases of research -identified childhood ADHD versus non-ADHD referents from a population -based birth cohort . Method : Young adults with research -identified childhood ADHD ( N = 232 ; mean age 27.0 yr ; 72.0 % men ) and referents ( N = 335 ; mean age 28.6 yr ; 62.7 % men ) from a 1976 to 1982 birth cohort ( N = 5699 ) were invited to participate in a followup study and were administered an academic achievement battery consisting of the basic reading component of the Woodcock-Johnson III Tests of Achievement ( WJ-III ) and the arithmetic subtest of the Wide Range Achievement Test — Third Edition ( WRAT-3 ) . Outcomes were compared between the 2 groups using linear regression models , adjusted for age , sex , and comorbid learning disability status . Results : Childhood ADHD cases scored from 3 to 5 grade equivalents lower on all academic tests compared with referents , with mean ( SD ) st and ard scores of 95.7 ( 8.4 ) versus 101.8 ( 8.1 ) in basic reading ; 95.0 ( 9.3 ) versus 101.9 ( 8.5 ) in letterword identification ; 98.2 ( 8.6 ) versus 103.2 ( 9.2 ) in passage comprehension ; 95.7 ( 9.1 ) versus 100.9 ( 9.0 ) in word attack ; and 87.8 ( 12.9 ) versus 98.0 ( 12.0 ) in arithmetic . Conclusion : This is the first prospect i ve , population -based study of adult academic outcomes of childhood ADHD . Our data provide evidence that childhood onset ADHD is associated with long-term underachievement in reading and math that may negatively impact ultimate educational attainment and occupational functioning in adulthood",
"Objectives : Previous studies have shown that serum levels of vitamin D were lower in attention deficit hyperactivity disorder ( ADHD ) children compared to healthy controls . The aim of the study was to determine the effect of vitamin D supplementation as adjunctive therapy to methylpheni date on symptoms of children with ADHD . Methods : Sixty-two children aged 5–12 years with a diagnosis of ADHD based on DSM-IV criteria were r and omly assigned into two groups to receive either 2000IU vitamin D or placebo in addition to methylpheni date for 8 weeks . Symptoms severity was assessed by Conner 's Parent Rating Scale-Revised[S ] ( CPRS ) , ADHD rating scale-IV ( ADHD-RS ) , and Weekly Parent Ratings of Evening and Morning Behavior ( WPREMB ) at weeks 0 , 4 , and 8 . Serum levels of 25(OH)D were measured at baseline and after 8 weeks . Anthropometric variables , dietary intake , physical activity , sun exposure , and side effects were assessed . Results : Fifty-four participants completed the trial . After 8 weeks of supplementation , serum levels of 25(OH)D significantly increased in the vitamin D group . ADHD symptoms decreased significantly in both groups ( P Evening symptoms and total score of WPREMB scale were significantly different at weeks 4 and 8 between the two groups ( P = 0.013 , 0.016 , respectively ) , but no differences were found in symptoms by CPRS and ADHD-RS scales . Discussion : Vitamin D supplementation as adjunctive therapy to methylpheni date improved ADHD evening symptoms . Future research is needed to clarify vitamin D effects as monotherapy in ADHD and its mechanism . The trial was registered in www.i rct .ir is ( I RCT 201404222394N10 )",
"Background In this research the symptom improvement of attention-deficit hyperactivity disorder ( ADHD ) of children was assessed by oral vitamin D administration in Tabriz , Iran . Methods In this double-blind , r and omized clinical trials , 96 children ( 2–18 years ) were enrolled to placebo and vitamin D groups . Children took vitamin D pearl ( 50,000 IU/week ) or placebo for 6 weeks . Children , who had the change in methylpheni date dosage and received any anticonvulsants and corticosteroids were excluded from the research . ADHD symptoms were diagnosed by Conners parent rating scale ( CPRS ) test at baseline and after intervention . ADHD Conners divided into inattention ( IA ) , hyperactivity/impulsivity ( H/I ) and combination type ( C ) subscales . Vitamin D serum level was assessed at baseline and after 8 weeks in both groups . Results The differences between CPRS and its subscales were not significant at baseline ( P > 0.05 ) . The Conners IA score was decreased in vitamin D group ( P . ADHD Conners and all subscale scores reduced remarkably after intervention in patients with insufficient level of vitamin D compared to placebo ( P Oral vitamin D improved ADHD symptoms with a particular effect on inattention symptoms . In addition , symptoms related to all subscales were improved remarkably in patients with insufficient level of vitamin D. Vitamin D treatment in children with ADHD could be considered due to the exp and benefit of vitamin D in body"
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PURPOSE To provide guidance to clinicians regarding the use of neoadjuvant chemotherapy and interval cytoreduction among women with stage IIIC or IV epithelial ovarian cancer . METHODS The Society of Gynecologic Oncology and the American Society of Clinical Oncology convened an Expert Panel and conducted a systematic review of the literature . RESULTS Four phase III clinical trials form the primary evidence base for the recommendations . The published studies suggest that for selected women with stage IIIC or IV epithelial ovarian cancer , neoadjuvant chemotherapy and interval cytoreduction are non-inferior to primary cytoreduction and adjuvant chemotherapy with respect to overall and progression-free survival and are associated with less perioperative morbidity and mortality . RECOMMENDATIONS All women with suspected stage IIIC or IV invasive epithelial ovarian cancer should be evaluated by a gynecologic oncologist prior to initiation of therapy . The primary clinical evaluation should include a CT of the abdomen and pelvis , and chest imaging ( CT preferred ) . Women with a high perioperative risk profile or a low likelihood of achieving cytoreduction to neoadjuvant chemotherapy . Women who are fit for primary cytoreductive surgery , and with potentially resectable disease , may receive either neoadjuvant chemotherapy or primary cytoreductive surgery . However , primary cytoreductive surgery is preferred if there is a high likelihood of achieving cytoreduction to acceptable morbidity . Before neoadjuvant chemotherapy is delivered , all patients should have confirmation of an invasive ovarian , fallopian tube , or peritoneal cancer . Additional information is available at www.asco.org/NACT-ovarian- guideline and www.asco.org/ guidelines wiki
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"OBJECTIVE Intraperitoneal ( IP ) chemotherapy prolongs survival in optimally reduced ovarian cancer patients . For patients in whom optimal debulking can not be achieved , one could incorporate IP therapy post-operatively if the cancer was optimally debulked following neoadjuvant chemotherapy . We sought to evaluate overall survival ( OS ) , progression-free survival ( PFS ) , percent of patients optimally debulked and toxicity in patients treated with this strategy . METHODS Women with adenocarcinoma by biopsy or cytology with stage III/IV ( pleural effusions only ) epithelial ovarian , fallopian tube or primary peritoneal carcinoma that presented with bulky disease were treated with neoadjuvant intravenous ( IV ) paclitaxel 175 mg/m2 and carboplatin AUC 6 q 21 daysx3 cycles followed by surgery ( if > /=50 % decrease in CA125 ) . If optimally debulked they received IV paclitaxel 175 mg/m2 and IP carboplatin AUC 5 ( day 1 ) and IP paclitaxel 60 mg/m2 ( day 8) q 28 daysx6 cycles . RESULTS Sixty-two patients were registered . Four were ineligible . Fifty-six were evaluated for neoadjuvant chemotherapy toxicities . One patient died of pneumonia . Five patients had grade 4 toxicity , including neutropenia ( 3 ) , anemia , leukopenia , anorexia , fatigue , muscle weakness , respiratory infection , and cardiac ischemia . Thirty-six patients had debulking surgery . Two had grade 4 hemorrhage . Twenty-six patients received post-cytoreduction chemotherapy . Four had grade 4 neutropenia . At a median follow-up of 21 months , median PFS is 21 months and median OS is 32 months for all 58 patients . PFS and OS for the 26 patients who received IV/IP chemotherapy is 29 and 34 months respectively . CONCLUSIONS These results compare favorably with other studies of sub-optimally debulked patients",
"BACKGROUND The primary analysis of the JGOG 3016 trial showed that a dose-dense paclitaxel and carboplatin regimen significantly improves progression-free and overall survival compared with the conventional regimen as first-line chemotherapy for patients with epithelial ovarian , fallopian tube , or primary peritoneal cancer . We report the long-term follow-up results for survival . METHODS This r and omised controlled trial was done at 85 centres in Japan . Patients with stage II-IV ovarian cancer were r and omly assigned to receive conventional treatment ( carboplatin area under the curve [ AUC ] 6 mg/mL per min and paclitaxel 180 mg/m(2 ) on day 1 ) or dose-dense treatment ( carboplatin AUC 6 mg/mL per min on day 1 and paclitaxel 80 mg/m(2 ) on days 1 , 8 , and 15 ) . The treatments were repeated every 3 weeks for six cycles ; responding patients had three additional cycles . The r and omisation was done central ly by telephone or fax , stratified by residual disease , stage , and histological type . The primary endpoint was progression-free survival ; overall survival was a secondary endpoint . Long-term information on adverse events was not collected . Efficacy analyses were by intention to treat . This study is registered with Clinical Trials.gov , number NCT00226915 . FINDINGS 637 patients were enrolled , of whom 631 were analysed ( 312 assigned to the dose-dense regimen , 319 to the conventional regimen ) . Median follow-up was 76·8 months ( IQR 68·9 - 85·6 ) . Median progression-free survival was significantly longer in the dose-dense treatment group than in the conventional treatment group ( 28·2 months [ 95 % CI 22·3 - 33·8 ] vs 17·5 months [ 15·7 - 21·7 ] ; hazard ratio [ HR ] 0·76 , 95 % CI 0·62 - 0·91 ; p=0·0037 ) . Median overall survival was 100·5 months ( 95 % CI 65·2-∞ ) in the dose-dense treatment group and 62·2 months ( 52·1 - 82·6 ) in the conventional treatment group ( HR 0·79 , 95 % CI 0·63 - 0·99 ; p=0·039 ) . INTERPRETATION Dose-dense treatment offers better survival than conventional treatment and is a potential new st and ard of care for first-line chemotherapy for patients with advanced epithelial ovarian cancer",
"BACKGROUND The international st and ard of care for women with suspected advanced ovarian cancer is surgical debulking followed by platinum-based chemotherapy . We aim ed to establish whether use of platinum-based primary chemotherapy followed by delayed surgery was an effective and safe alternative treatment regimen . METHODS In this phase 3 , non-inferiority , r and omised , controlled trial ( CHORUS ) undertaken in 87 hospitals in the UK and New Zeal and , we enrolled women with suspected stage III or IV ovarian cancer . We r and omly assigned women ( 1:1 ) either to undergo primary surgery followed by six cycles of chemotherapy , or to three cycles of primary chemotherapy , then surgery , followed by three more cycles of completion chemotherapy . Each 3-week cycle consisted of carboplatin AUC5 or AUC6 plus paclitaxel 175 mg/m(2 ) , or an alternative carboplatin combination regimen , or carboplatin monotherapy . We did the r and om assignment by use of a minimisation method with a r and om element , and stratified participants according to the r and omising centre , largest radiological tumour size , clinical stage , and prespecified chemotherapy regimen . Patients and investigators were not masked to group assignment . The primary outcome measure was overall survival . Primary analyses were done in the intention-to-treat population . To establish non-inferiority , the upper bound of a one-sided 90 % CI for the hazard ratio ( HR ) had to be less than 1.18 . This trial is registered , number IS RCT N74802813 , and is closed to new participants . FINDINGS Between March 1 , 2004 , and Aug 30 , 2010 , we r and omly assigned 552 women to treatment . Of the 550 women who were eligible , 276 were assigned to primary surgery and 274 to primary chemotherapy . All were included in the intention-to-treat analysis ; 251 assigned to primary surgery and 253 to primary chemotherapy were included in the per- protocol analysis . As of May 31 , 2014 , 451 deaths had occurred : 231 in the primary -surgery group versus 220 in the primary -chemotherapy group . Median overall survival was 22.6 months in the primary -surgery group versus 24.1 months in primary chemotherapy . The HR for death was 0.87 in favour of primary chemotherapy , with the upper bound of the one-sided 90 % CI 0.98 ( 95 % CI 0.72 - 1.05 ) . Grade 3 or 4 postoperative adverse events and deaths within 28 days after surgery were more common in the primary -surgery group than in the primary -chemotherapy group ( 60 [ 24 % ] of 252 women vs 30 [ 14 % ] of 209 , p=0.0007 , and 14 women [ 6 % ] vs 1 woman [ grade 3 or 4 postoperative adverse event was haemorrhage in both groups ( 8 women [ 3 % ] in the primary -surgery group vs 14 [ 6 % ] in the primary -chemotherapy group ) . 110 ( 49 % ) of 225 women receiving primary surgery and 102 ( 40 % ) of 253 receiving primary chemotherapy had a grade 3 or 4 chemotherapy related toxic effect ( p=0.0654 ) , mostly uncomplicated neutropenia ( 20 % and 16 % , respectively ) . One fatal toxic effect , neutropenic sepsis , occurred in the primary -chemotherapy group . INTERPRETATION In women with stage III or IV ovarian cancer , survival with primary chemotherapy is non-inferior to primary surgery . In this study population , giving primary chemotherapy before surgery is an acceptable st and ard of care for women with advanced ovarian cancer . FUNDING Cancer Research UK and the Royal College of Obstetricians and Gynaecologists",
"PURPOSE To compare the efficacy and safety of pegylated liposomal doxorubicin ( PLD ) and topotecan in patients with epithelial ovarian carcinoma that recurred after or did n't respond to first-line , platinum-based chemotherapy . PATIENTS AND METHODS Patients with measurable and assessable disease were r and omized to receive either PLD 50 mg/m(2 ) as a 1-hour infusion every 4 weeks or topotecan 1.5 mg/m(2)/d for 5 consecutive days every 3 weeks . Patients were stratified prospect ively for platinum sensitivity and for the presence or absence of bulky disease . RESULTS A total of 474 patients were treated ( 239 PLD and 235 topotecan ) . They comprised the intent-to-treat population . The overall progression-free survival rates were similar between the two arms ( P = .095 ) . The overall response rates for PLD and topotecan were 19.7 % and 17.0 % , respectively ( P = .390 ) . Median overall survival times were 60 weeks for PLD and 56.7 weeks for topotecan . Data analyzed in platinum-sensitive patients demonstrated a statistically significant benefit from PLD for progression-free survival ( P = .037 ) , with medians of 28.9 for PLD versus 23.3 weeks for topotecan . For overall survival , PLD was significantly superior to topotecan ( P = .008 ) , with a median of 108 weeks versus 71.1 weeks . The platinum-refractory subgroup demonstrated a nonstatistically significant survival trend in favor of topotecan ( P = .455 ) . Severe hematologic toxicity was more common with topotecan and was more likely to be associated with dosage modification , or growth factor or blood product utilization . CONCLUSION The comparable efficacy , favorable safety profile , and convenient dosing support the role of PLD as a valuable treatment option in this patient population",
"BACKGROUND Despite considerable improvement in the treatment of advanced ovarian cancer , the optimization of efficacy and tolerability remains an important issue . Therefore , we performed a r and omized , phase III non-inferiority trial comparing paclitaxel plus cisplatin ( PT ) with paclitaxel plus carboplatin ( TC ) in patients with advanced ovarian cancer . METHODS A total of 798 patients with International Federation of Gynecology and Obstetrics stage IIB-IV were r and omly assigned to receive six courses of either PT or TC at 3-week intervals . The primary endpoint was the proportion of patients without progression at 2 years . Secondary endpoints included toxicity , response to treatment , quality of life , and overall and progression-free survival time . Quality of life was evaluated using the European Organization for Research and Treatment of Cancer quality -of-life question naire (QLQ)-C30 , version 2.0 . Survival curves were calculated using the Kaplan-Meier method , and hazard ratios were estimated using the Cox proportional hazards model . RESULTS The proportion of patients without progression at 2 years was not statistically significantly different between the two treatment arms ( 40.0 % for PT versus 37.5 % for TC , difference = 2.5 % , one-sided 95 % confidence interval [ CI ] = - infinity to 8.2 % ) . Median progression-free survival time in the TC arm ( 17.2 months , 95 % CI = 15.2 to 19.3 months ) and the PT arm ( 19.1 months , 95 % CI = 16.7 to 21.5 months ) were also not statistically significantly different ; the same was true of median overall survival time ( 43.3 months , 95 % CI = 37.2 to 47.8 months versus 44.1 months , 95 % CI = 40.2 to 49.4 months , for the TC and PT arms , respectively ) . The TC regimen was associated with a higher frequency of hematologic toxicity , but a lower frequency of gastrointestinal and neurologic toxicity , than the PT regimen . Mean global quality -of-life scores at the end of treatment were statistically significantly better in the TC arm than in the PT arm ( 65.25 versus 51.97 , respectively ; difference = -13.28 , 95 % CI = -18.88 to -7.68 ) . CONCLUSION The TC regimen achieved comparable efficacy to the PT regimen but was associated with better tolerability and quality of life , and should , therefore , be considered as an important alternative for st and ard first-line chemotherapy in patients with advanced ovarian cancer",
"OBJECTIVE The use of tumor debulking surgery in the management of epithelial ovarian cancer ( EOC ) , which is often disseminated in the peritoneal cavity at the time of diagnosis , has a significant impact on prognosis . We compared (18)F-fluorodeoxyglucose ( FDG ) positron emission tomography/contrast-enhanced computed tomography ( PET/CT ) to contrast-enhanced CT for the detection of dissemination into the abdominal cavity preventing successful primary debulking surgery . METHODS Forty-one women with EOC underwent preoperative whole-body low-dose FDG-PET/CT followed by diagnostic high dose contrast-enhanced CT scan , and the results were compared with systematic ally recorded surgical findings as a reference st and ard . Both site-based and patient-based analyses were conducted . RESULTS FDG-PET/CT was superior to conventional CT for the detection of carcinomatosis in subdiaphragmatic peritoneal surfaces ( p=0.020 ) and in the bowel mesentery ( p=0.001 ) . Patient-based analysis of upper abdominal areas requiring extensive surgical procedures showed no significant differences between the two imaging methods . The sensitivity of PET/CT and CT was poor in certain areas of the peritoneal cavity ( 64 % vs. 27 % in the small bowel mesentery and 65 % vs. 55 % in the right upper abdomen ) . Extra-abdominal disease spread was detected by PET/CT in 32 patients and by CT in 25 patients . CONCLUSIONS PET/CT was not superior to CT for the detection of intra-abdominal disease spread . Patients with suspected EOC should be referred for upfront radical surgery regardless of the results of preoperative imaging studies . PET/CT is more effective for the detection of extra-abdominal disease than CT , but the clinical significance of this finding is unclear",
"PURPOSE In r and omized trials the combination of cisplatin and paclitaxel was superior to cisplatin and cyclophosphamide in advanced-stage epithelial ovarian cancer . Although in nonr and omized trials , carboplatin and paclitaxel was a less toxic and highly active combination regimen , there remained concern regarding its efficacy in patients with small-volume , resected , stage III disease . Thus , we conducted a noninferiority trial of cisplatin and paclitaxel versus carboplatin and paclitaxel in this population . PATIENTS AND METHODS Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were r and omly assigned to receive cisplatin 75 mg/m2 plus a 24-hour infusion of paclitaxel 135 mg/m2 ( arm I ) , or carboplatin area under the curve 7.5 intravenously plus paclitaxel 175 mg/m2 over 3 hours ( arm II ) . RESULTS Seven hundred ninety-two eligible patients were enrolled onto the study . Prognostic factors were similar in the two treatment groups . Gastrointestinal , renal , and metabolic toxicity , as well as grade 4 leukopenia , were significantly more frequent in arm I. Grade 2 or greater thrombocytopenia was more common in arm II . Neurologic toxicity was similar in both regimens . Median progression-free survival and overall survival were 19.4 and 48.7 months , respectively , for arm I compared with 20.7 and 57.4 months , respectively , for arm II . The relative risk ( RR ) of progression for the carboplatin plus paclitaxel group was 0.88 ( 95 % confidence interval [ CI ] , 0.75 to 1.03 ) and the RR of death was 0.84 ( 95 % CI , 0.70 to 1.02 ) . CONCLUSION In patients with advanced ovarian cancer , a chemotherapy regimen consisting of carboplatin plus paclitaxel results in less toxicity , is easier to administer , and is not inferior , when compared with cisplatin plus paclitaxel",
"OBJECTIVE The objective of the study was to prospect ively evaluate the accuracy of laparoscopy performed in satellite centers ( SCs ) to describe intraabdominal diffusion of advanced ovarian cancer ( AOC ) . STUDY DESIGN Patients with a clinical /radiological suspicion of AOC were included in the protocol . SCs were selected among those surgeons , spending a short intensive training period at the coordinator center ( CC ) to learn the application of staging laparoscopy ( S-LPS ) in AOC . All women underwent S-LPS at the SCs , and the surgical procedure was recorded and blindly review ed at the CC . Calculating specificity , positive and negative predictive values , and the accuracy for each parameter with respect to the CC assessed the diagnostic performance of S-LPS . The Cohen 's kappa was used to test the interobserver agreement of each parameter . RESULTS One hundred sixty-eight cases were considered eligible for the study . A per- protocol analysis was performed on 120 cases . The worst laparoscopic assessable feature was mesenteric retraction , whereas the remaining variables ranged from 99.2 % ( peritoneal carcinomatosis ) to 90 % ( bowel infiltration ) . All but 1 SC ( SC number 4 ) reached an accuracy rate of 80 % or greater for both single parameters and overall score . The Cohen 's kappa and the P value for overall predicitive index value were 0.685 and .01 , respectively , but improved to 0.773 and .388 after removing the SC number 4 from the analysis . CONCLUSION S-LPS allows an accurate and reliable assessment of intraperitoneal diffusion of disease in AOC patients in trained gynecological oncology centers",
"Objectives To evaluate whole-body MRI with diffusion-weighted sequence ( WB-DWI/MRI ) for staging and assessing operability compared with CT and FDG-PET/CT in patients with suspected ovarian cancer . Methods Thirty-two patients underwent 3-T WB-DWI/MRI , 18 F-fluorodeoxyglucose positron emission tomography/computed tomography ( FDG-PET/CT ) and CT before diagnostic open laparoscopy ( DOL ) . Imaging findings for tumour characterisation , peritoneal and retroperitoneal staging were correlated with histopathology after DOL and /or open surgery . For distant metastases , FDG-PET/CT or image-guided biopsies were the reference st and ards . For tumour characterisation and peritoneal staging , WB-DWI/MRI was compared with CT and FDG-PET/CT . Interobserver agreement for WB-DWI/MRI was determined . Results WB-DWI/MRI showed 94 % accuracy for primary tumour characterisation compared with 88 % for CT and 94 % for FDG-PET/CT . WB-DWI/MRI showed higher accuracy of 91 % for peritoneal staging compared with CT ( 75 % ) and FDG-PET/CT ( 71 % ) . WB-DWI/MRI and FDG-PET/CT showed higher accuracy of 87 % for detecting retroperitoneal lymphadenopathies compared with CT ( 71 % ) . WB-DWI/MRI showed excellent correlation with FDG-PET/CT ( κ = 1.00 ) for detecting distant metastases compared with CT ( κ = 0.34 ) . Interobserver agreement was moderate to almost perfect ( κ = 0.58–0.91 ) . Conclusions WB-DWI/MRI shows high accuracy for characterising primary tumours , peritoneal and distant staging compared with CT and FDG-PET/CT and may be valuable for assessing operability in ovarian cancer patients .Key Points• Whole-body MRI with diffusion weighting ( WB-DWI/MRI ) helps to assess the operability of suspected ovarian cancer.• Interobserver agreement is good for primary tumour characterisation , peritoneal and distant staging.• WB-DWI/MRI improves mesenteric/serosal metastatic spread assessment compared with CT and FDG-PET/CT.• Retroperitoneal/cervical-thoracic nodal staging using qualitative DWI criteria was reasonably accurate.• WB-DWI/MRI and FDG-PET/CT showed the highest diagnostic impact for detecting thoracic metastases",
"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",
"OBJECTIVE We investigated the influence of hospital and gynecologist level of specialization and volume on surgical results and on survival of ovarian cancer patients . METHODS Data were collected from 1077 ovarian cancer patients treated from 1996 to 2003 in a r and om sample of 18 Dutch hospitals . Hospitals and gynecologists were classified according to specialization ( general , semi-specialized or specialized ) and by volume ( 12 cases/year ) . Outcomes were percentage of adequately staged and optimally debulked patients and length of overall survival . Data were analyzed using multivariable logistic regression ( surgical results ) and Cox regression ( survival ) . RESULTS The level of specialization and the volume of hospitals and of gynecologists were strongly related to the proportion of adequately staged patients ( adjusted odds ratio ( OR ) specialized hospitals 3.9 ( 95 % confidence interval ( CI ) 2.0 - 7.6 ) ; specialized gynecologists 9.5 ( 95 % CI 4.7 - 19 ) ) . Patients with stage III disease had a higher chance of optimal debulking when treated in specialized hospitals ( adjusted OR 1.7 ( 95 % CI 1.1 - 2.7 ) ) or by high volume gynecologists ( adjusted OR 2.8 ( 95 % CI 1.4 - 5.7 ) ) . Overall survival was best in patients treated in specialized hospitals and by high-volume gynecologists . CONCLUSION The specialization level of hospitals and the surgical volume of gynecologists positively influence outcomes of surgery and survival . Concentration of ovarian cancer care thus seems warranted",
"OBJECTIVE To establishing whether neoadjuvant chemotherapy ( NACT ) followed by interval debulking surgery ( IDS ) is superior primary debulking surgery ( PDS ) in terms of clinical outcome as well as peri-operative morbidity in advanced epithelial ovarian cancer ( AEOC ) endowed with high tumour load ( HTL ) . MATERIAL AND METHODS This is a single-Institution , superiority , r and omised phase III trial enrolling supposed AEOC women . Patients considered pre-operatively eligible were triaged to staging laparoscopy to assess the predictive index ( PI ) of tumour load . All AEOC women with PI≥8 or≤12 ( considered as HTL ) were included . They were r and omly assigned ( 1:1 ratio ) to undergo either PDS followed by systemic adjuvant chemotherapy ( arm A , st and ard ) , or NACT followed by IDS ( NACT/IDS ) ( arm B , experimental ) . Co- primary outcome measures were postoperative complications ( grade d according to the Memorial Sloan Kettering Cancer Center surgical secondary events grading system ) and progression free survival ( PFS ) ; secondary outcomes were overall survival , and quality of life ( QoL ) . QoL was assessed using the EORTC QoL question naires . A sample size of 110 patients was required for the analysis of the first co- primary end-point ( major peri-operative morbidity ) whereas recruitment is still on-going to achieve the statistical power on PFS . RESULTS Between October 2011 and November 2014 , we registered 280 AEOC . Of the 110 eligible women , 55 were assigned to arm A and 55 to arm B. Despite different extension of surgery , rates of complete residual disease ( residual tumour=0 cm ) were superimposable between the groups ( 45.5 % versus 57.7 % ; p=0.206 ) . Twenty-nine patients ( 52.7 % ) in arm A experienced early grade III-IV complications versus three patients ( 5.7 % ) in IDS ( p=0.0001 ) . The most common complication was grade III and consisted of symptomatic pleural effusion requiring thoracic drainage ( 17/55 women ( 30.9 % ) in arm A versus 1/52 ( 1.9 % ) in arm B , p=0.0001 ) . Three grade IV ( 5.4 % ) ( i.e. , two re-operations for postoperative haemorrhage and one septic multi-organ failure ) , and two grade V ( 3.6 % ) ( two deaths for acute cardiopulmonary failure ) early complications were observed in arm A only . Mean QoL scores of several scales/items were shown to ameliorate over time in both arms . Emotional functioning , cognitive functioning , nausea/vomiting , dyspnoea , insomnia and hair loss were statistically and clinical ly better in NACT/IDS compared to PDS arm . CONCLUSIONS Perioperative moderate/severe morbidity as well as QoL scores were shown to be more favourable in NACT/IDS arm than PDS in AEOC patients with very HTL . Completion of patient enrolment and analysis of survival data will clarify whether PDS with such a high rate of severe complications is an acceptable treatment in AEOC women with HTL",
"OBJECTIVE : To identify factors associated with increased 30-day mortality after advanced ovarian cancer debulking among elderly women . METHODS : A data base linking Medicare records with the Surveillance , Epidemiology , and End Results ( SEER ) data was used to identify a cohort of 5,475 women aged 65 and older who had primary debulking surgery for stage III or IV epithelial ovarian cancer ( diagnosed 1995–2005 ) . Women were stratified by acuity of hospital admission . Multivariable analysis was performed to identify patient-related and treatment-related variables associated with 30-day mortality . RESULTS : Five thous and four hundred seventy-five women had surgery for advanced ovarian cancer , and the overall 30-day mortality was 8.2 % . Women admitted electively had a 30-day mortality of 5.6 % ( 251 of 4,517 ) , and those admitted emergently had a 30-day mortality of 20.1 % ( 168 of 835 ) . Advancing age , increasing stage , and increasing comorbidity score were all associated with an increase in 30-day mortality ( all P 30-day mortality of 12.7 % ( 95 % confidence interval 10.7%–14.9 % ) . CONCLUSION : Age , cancer stage , and comorbidity scores may be helpful to stratify electively admitted patients based on predicted postoperative mortality . If vali date d in a prospect i ve cohort , then these factors may help identify women who may benefit from alternative treatment strategies . LEVEL OF EVIDENCE :",
"BACKGROUND Intravenous platinum-based chemotherapy is the st and ard primary therapy for advanced ovarian cancer . We conducted a phase 3 trial to compare the effects of intraperitoneal and intravenous cisplatin on the survival of women with previously untreated , stage III , epithelial ovarian cancer . METHODS The patients underwent an initial exploratory laparotomy and resection of all tumor masses larger than 2 cm . Within four weeks after surgery , six courses of intravenous cyclophosphamide ( 600 mg per square meter of body-surface area per course ) plus either intraperitoneal cisplatin ( 100 mg per square meter ) or intravenous cisplatin ( 100 mg per square meter ) were administered at three-week intervals . RESULTS Of 654 r and omized patients , 546 were eligible for the study . The estimated median survival was significantly longer in the group receiving intraperitoneal cisplatin ( 49 months ; 95 percent confidence interval , 42 to 56 ) than in the group receiving intravenous cisplatin ( 41 months ; 95 percent confidence interval , 34 to 47 ) . The risk of death was lower in the intraperitoneal group than in the intravenous group ( hazard ratio , 0.76 ; 95 percent confidence interval , 0.61 to 0.96 ; P = 0.02 ) . Moderate-to-severe tinnitus , clinical hearing loss , and neuromuscular toxic effects were significantly more frequent in the intravenous group . CONCLUSIONS As compared with intravenous cisplatin , intraperitoneal cisplatin significantly improves survival and has significantly fewer toxic effects in patients with stage III ovarian cancer and residual tumor masses of 2 cm or less",
"Three large r and omized clinical trials have shown a survival benefit in women with stage iii epithelial ovarian cancer ( eoc ) who receive intraperitoneal ( IP ) chemotherapy after optimal primary debulking surgery . The most recent Gynecologic Oncology Group study , gog 172 , showed an improvement in median overall survival of approximately 17 months . That result led to a U.S. National Cancer Institute ( nci ) clinical announcement recommending that IP chemotherapy be considered for this group of women with eoc . However , IP chemotherapy is associated with increased toxicity , and rates for completion of treatment are low ( 42 % in gog 172 ) . The optimal IP regimen and duration of treatment has yet to be defined . Women undergoing chemotherapy before optimal debulking surgery were not included in the studies or in the nci clinical announcement . The National Cancer Institute of Canada Clinical Trials Group has developed a protocol for a r and omized phase ii/iii study which will examine whether IP platinum-taxane-based chemotherapy benefits women who have received neoadjuvant chemotherapy before optimal surgical debulking . To address whether the less systemically toxic carboplatin can be substituted for cisplatin IP , the first phase of the study will have 3 arms : 1 intravenous-only , and 2 IP-containing regimens . At the end of the first stage , and provided that IP therapy is feasible to administer in this patient population , one of the IP regimens , either IP carboplatin or IP cisplatin , will proceed into a phase iii comparison with the intravenous arm . This exciting new study has gathered international support",
"Summary Background The ICON7 trial previously reported improved progression-free survival in women with ovarian cancer with the addition of bevacizumab to st and ard chemotherapy , with the greatest effect in patients at high risk of disease progression . We report the final overall survival results of the trial . Methods ICON7 was an international , phase 3 , open-label , r and omised trial undertaken at 263 centres in 11 countries across Europe , Canada , Australia and New Zeal and . Eligible adult women with newly diagnosed ovarian cancer that was either high-risk early-stage disease ( International Federation of Gynecology and Obstetrics [ FIGO ] stage I – IIa , grade 3 or clear cell histology ) or more advanced disease ( FIGO stage IIb – IV ) , with an Eastern Cooperative Oncology Group performance status of 0–2 , were enrolled and r and omly assigned in a 1:1 ratio to st and ard chemotherapy ( six 3-weekly cycles of intravenous carboplatin [ AUC 5 or 6 ] and paclitaxel 175 mg/m2 of body surface area ) or the same chemotherapy regimen plus bevacizumab 7·5 mg per kg bodyweight intravenously every 3 weeks , given concurrently and continued with up to 12 further 3-weekly cycles of maintenance therapy . R and omisation was done by a minimisation algorithm stratified by FIGO stage , residual disease , interval between surgery and chemotherapy , and Gynecologic Cancer InterGroup group . The primary endpoint was progression-free survival ; the study was also powered to detect a difference in overall survival . Analysis was by intention to treat . This trial is registered as an International St and ard R and omised Controlled Trial , number IS RCT N91273375 . Findings Between Dec 18 , 2006 , and Feb 16 , 2009 , 1528 women were enrolled and r and omly assigned to receive chemotherapy ( n=764 ) or chemotherapy plus bevacizumab ( n=764 ) . Median follow-up at the end of the trial on March 31 , 2013 , was 48·9 months ( IQR 26·6–56·2 ) , at which point 714 patients had died ( 352 in the chemotherapy group and 362 in the bevacizumab group ) . Our results showed evidence of non-proportional hazards , so we used the difference in restricted mean survival time as the primary estimate of effect . No overall survival benefit of bevacizumab was recorded ( restricted mean survival time 44·6 months [ 95 % CI 43·2–45·9 ] in the st and ard chemotherapy group vs 45·5 months [ 44·2–46·7 ] in the bevacizumab group ; log-rank p=0·85 ) . In an exploratory analysis of a predefined subgroup of 502 patients with poor prognosis disease , 332 ( 66 % ) died ( 174 in the st and ard chemotherapy group and 158 in the bevacizumab group ) , and a significant difference in overall survival was noted between women who received bevacizumab plus chemotherapy and those who received chemotherapy alone ( restricted mean survival time 34·5 months [ 95 % CI 32·0–37·0 ] with st and ard chemotherapy vs 39·3 months [ 37·0–41·7 ] with bevacizumab ; log-rank p=0·03 ) . However , in non-high-risk patients , the restricted mean survival time did not differ significantly between the two treatment groups ( 49·7 months [ 95 % CI 48·3–51·1 ] ) in the st and ard chemotherapy group vs 48·4 months [ 47·0–49·9 ] in the bevacizumab group ; p=0·20 ) . An up date d analysis of progression-free survival showed no difference between treatment groups . During extended follow-up , one further treatment-related grade 3 event ( gastrointestinal fistula in a bevacizumab-treated patient ) , three grade 2 treatment-related events ( cardiac failure , sarcoidosis , and foot fracture , all in bevacizumab-treated patients ) , and one grade 1 treatment-related event ( vaginal haemorrhage , in a patient treated with st and ard chemotherapy ) were reported . Interpretation Bevacizumab , added to platinum-based chemotherapy , did not increase overall survival in the study population as a whole . However , an overall survival benefit was recorded in poor-prognosis patients , which is concordant with the progression-free survival results from ICON7 and GOG-218 , and provides further evidence towards the optimum use of bevacizumab in the treatment of ovarian cancer . Funding The National Institute for Health Research through the UK National Cancer Research Network , the Medical Research Council , and Roche",
"BACKGROUND Carboplatin plus paclitaxel administered every 3 weeks is st and ard first-line chemotherapy for patients with advanced ovarian cancer . A weekly paclitaxel schedule combined with carboplatin every 3 weeks prolonged progression-free survival and overall survival in a Japanese phase 3 trial . The aim of our study was to assess whether a weekly schedule of carboplatin plus paclitaxel is more effective than the same drugs given every 3 weeks . METHODS We did a multicentre , r and omised , phase 3 study at 67 institutions in Italy and France . Women with FIGO stage IC-IV ovarian cancer , an ECOG performance status of 2 or lower , and who had never received chemotherapy were r and omly allocated in a 1:1 ratio to receive either carboplatin ( AUC 6 mg/mL per min ) plus paclitaxel ( 175 mg/m(2 ) ) every 3 weeks for six cycles or carboplatin ( AUC 2 mg/mL per min ) plus paclitaxel ( 60 mg/m(2 ) ) every week for 18 weeks . R and omisation was done by computer-based minimisation , stratified by centre , residual disease after surgery , and ECOG performance status . The study was not blinded . Co primary endpoints were progression-free survival and quality of life ( assessed by the Functional Assessment of Cancer Therapy Ovarian Trial Outcome Index [ FACT-O/TOI ] score ) , and analysis was by modified intention to treat . This report presents the final analysis . The study is registered with Clinical Trials.gov , number NCT00660842 . FINDINGS 822 patients were enrolled into the study between Nov 20 , 2008 , and March 1 , 2012 ; 12 withdrew their consent immediately after r and omisation and were excluded , and 810 were eligible for analysis . 404 women were allocated treatment every 3 weeks and 406 were assigned to the weekly schedule . After median follow-up of 22·3 months ( IQR 16·2 - 30·9 ) , 449 progression-free survival events were recorded . Median progression-free survival was 17·3 months ( 95 % CI 15·2 - 20·2 ) in patients assigned to treatment every 3 weeks , versus 18·3 months ( 16·8 - 20·9 ) in women allocated to the weekly schedule ( hazard ratio 0·96 , 95 % CI 0·80 - 1·16 ; p=0·66 ) . FACT-O/TOI scores differed significantly between the two schedules ( treatment-by-time interaction p , FACT-O/TOI scores worsened at every cycle ( weeks 1 , 4 , and 7 ) , whereas for the weekly schedule , after transient worsening at week 1 , FACT-O/TOI scores remained stable . Fewer patients assigned to the weekly group than those allocated treatment every 3 weeks had grade 3 - 4 neutropenia ( 167 [ 42 % ] of 399 patients vs 200 [ 50 % ] of 400 patients ) , febrile neutropenia ( two [ 0·5 % ] vs 11 [ 3 % ] ) , grade 3 - 4 thrombocytopenia ( four [ 1 % ] vs 27 [ 7 % ] ) , and grade 2 or worse neuropathy ( 24 [ 6 % ] vs 68 [ 17 % ] ) . Three deaths during the study were attributed to chemotherapy ; two women died who were allocated treatment every 3 weeks and one death was recorded in the group assigned the weekly regimen . INTERPRETATION A weekly regimen of carboplatin and paclitaxel might be a reasonable option for first-line treatment of women with advanced ovarian cancer . FUNDING None",
"OBJECTIVE Treatment for advanced-stage epithelial ovarian cancer ( AEOC ) includes primary debulking surgery ( PDS ) or neoadjuvant chemotherapy ( NACT ) . A r and omized controlled trial comparing these treatments result ed in comparable overall survival ( OS ) . Studies report more complications and lower chemotherapy completion rates in patients 65 years old or older receiving PDS . We sought to evaluate the cost implication s of NACT relative to PDS in AEOC patients 65 years old or older . STUDY DESIGN A 5 year Markov model was created . Arm 1 modeled PDS followed by 6 cycles of carboplatin and paclitaxel ( CT ) . Arm 2 modeled 3 cycles of CT , followed by interval debulking surgery and then 3 additional cycles of CT . Parameters included OS , surgical complications , probability of treatment initiation , treatment cost , and quality of life ( QOL ) . OS was assumed to be equal based on the findings of the international r and omized control trial . Differences in surgical complexity were accounted for in base surgical cost plus add-on procedure costs weighted by occurrence rates . Hospital cost was a weighted average of diagnosis-related group costs weighted by composite estimates of complication rates . Sensitivity analyses were performed . RESULTS Assuming equal survival , NACT produces a cost savings of $ 5616 . If PDS improved median OS by 1.5 months or longer , PDS would be cost effective ( CE ) at a $ 100,000/ quality -adjusted life-year threshold . If PDS improved OS by 3.2 months or longer , it would be CE at a $ 50,000 threshold . The model was robust to variation in costs and complication rates . Moderate decreases in the QOL with NACT would result in PDS being CE . CONCLUSION A model based on the RCT comparing NACT and PDS showed NACT is a cost-saving treatment compared with PDS for AEOC in patients 65 years old or older . Small increases in OS with PDS or moderate declines in QOL with NACT would result in PDS being CE at the $ 100,000/ quality -adjusted life-year threshold . Our results support further evaluation of the effects of PDS on OS , QOL and complications in AEOC patients 65 years old or older",
"PURPOSE Conflicting results on prognostic factors for advanced epithelial ovarian cancer ( EOC ) have been reported because of small sample size and heterogeneity of study population . The purpose of this study was to identify factors predictive of poor prognosis in a similarly treated population of women with advanced EOC . PATIENTS AND METHODS A retrospective review of demographic , pathologic , treatment , and outcome data from 1,895 patients with International Federation of Gynecology and Obstetrics stage III EOC who had undergone primary surgery followed by six cycles of intravenous platinum/paclitaxel was conducted . A proportional hazards model was used to assess the association of prognostic factors with progression-free survival ( PFS ) and overall survival ( OS ) . RESULTS Increasing age was associated with increased risks for disease progression ( HR = 1.06 ; 95 % CI , 1.02 to 1.11 for an increase every 10 years ) and death ( HR = 1.12 ; 95 % CI , 1.06 to 1.18 ) . Mucinous or clear-cell histology was associated with a worse PFS and OS compared with serous carcinomas . Patients with performance status ( PS ) 1 or 2 were at an increased risk for recurrence compared with PS 0 ( HR = 1.12 ; 95 % CI , 1.01 to 1.24 ) . Compared with patients with microscopic residual disease , patients with 0.1 to 1.0 cm and > 1.0 cm residual disease had an increased risk of recurrence ( HR = 1.96 ; 95 % CI , 1.70 to 2.26 ; and HR = 2.36 ; 95 % CI , 2.04 to 2.73 , respectively ) and death ( HR = 2.11 ; 95 % CI , 1.78 to 2.49 ; P Age , PS , tumor histology , and residual tumor volume were independent predictors of prognosis in patients with stage III EOC . These data can be used to identify patients with poor prognosis and to design future tailored r and omized clinical trials",
"PURPOSE To compare the progression-free and overall survival in small-volume residual ovarian cancer after treatment with intravenous ( IV ) cisplatin and paclitaxel or an experimental regimen of IV carboplatin followed by IV paclitaxel and intraperitoneal cisplatin . PATIENTS AND METHODS Patients were r and omized to receive either IV paclitaxel 135 mg/m(2 ) over 24 hours followed by IV cisplatin 75 mg/m(2 ) every 3 weeks for six courses or IV carboplatin ( area under curve 9 ) every 28 days for two courses , then IV paclitaxel 135 mg/m(2 ) over 24 hours followed by intraperitoneal ( IP ) cisplatin 100 mg/m(2 ) every 3 weeks for six courses . RESULTS Of the 523 patients who entered this trial , 462 were determined to be assessable , with prognostic factors well balanced between the treatments . Neutropenia , thrombocytopenia , and gastrointestinal and metabolic toxicities were greater in the experimental arm . As a result , 18 % of the patients received Progression-free survival was superior for patients r and omized to the experimental treatment arm ( median , 28 v 22 months ; relative risk , 0.78 ; log-rank P = .01 , one-tail ) . There was a borderline improvement in overall survival associated with this regimen ( median , 63 v 52 months ; relative risk , 0.81 ; P = .05 , one-tail ) . CONCLUSION An experimental regimen including moderately high-dose IV carboplatin followed by IP paclitaxel and IV cisplatin yielded a significant improvement in progression-free survival when compared with a st and ard regimen of IV cisplatin and paclitaxel . Because the improvement in overall survival was of borderline statistical significance and toxicity was greater , the experimental arm is not recommended for routine use . However , the results provide direction for further clinical investigation in small-volume ovarian cancer",
"BACKGROUND Primary debulking surgery before initiation of chemotherapy has been the st and ard of care for patients with advanced ovarian cancer . METHODS We r and omly assigned patients with stage IIIC or IV epithelial ovarian carcinoma , fallopian-tube carcinoma , or primary peritoneal carcinoma to primary debulking surgery followed by platinum-based chemotherapy or to neoadjuvant platinum-based chemotherapy followed by debulking surgery ( so-called interval debulking surgery ) . RESULTS Of the 670 patients r and omly assigned to a study treatment , 632 ( 94.3 % ) were eligible and started the treatment . The majority of these patients had extensive stage IIIC or IV disease at primary debulking surgery ( metastatic lesions that were larger than 5 cm in diameter in 74.5 % of patients and larger than 10 cm in 61.6 % ) . The largest residual tumor was 1 cm or less in diameter in 41.6 % of patients after primary debulking and in 80.6 % of patients after interval debulking . Postoperative rates of adverse effects and mortality tended to be higher after primary debulking than after interval debulking . The hazard ratio for death ( intention-to-treat analysis ) in the group assigned to neoadjuvant chemotherapy followed by interval debulking , as compared with the group assigned to primary debulking surgery followed by chemotherapy , was 0.98 ( 90 % confidence interval [ CI ] , 0.84 to 1.13 ; P=0.01 for noninferiority ) , and the hazard ratio for progressive disease was 1.01 ( 90 % CI , 0.89 to 1.15 ) . Complete resection of all macroscopic disease ( at primary or interval surgery ) was the strongest independent variable in predicting overall survival . CONCLUSIONS Neoadjuvant chemotherapy followed by interval debulking surgery was not inferior to primary debulking surgery followed by chemotherapy as a treatment option for patients with bulky stage IIIC or IV ovarian carcinoma in this study . Complete resection of all macroscopic disease , whether performed as primary treatment or after neoadjuvant chemotherapy , remains the objective whenever cytoreductive surgery is performed . ( Funded by the National Cancer Institute ; Clinical Trials.gov number , NCT00003636 .",
"BACKGROUND A dose-dense weekly schedule of paclitaxel ( result ing in a greater frequency of drug delivery ) plus carboplatin every 3 weeks or the addition of bevacizumab to paclitaxel and carboplatin administered every 3 weeks has shown efficacy in ovarian cancer . We proposed to determine whether dose-dense weekly paclitaxel and carboplatin would prolong progression-free survival as compared with paclitaxel and carboplatin administered every 3 weeks among patients receiving and those not receiving bevacizumab . METHODS We prospect ively stratified patients according to whether they elected to receive bevacizumab and then r and omly assigned them to receive either paclitaxel , administered intravenously at a dose of 175 mg per square meter of body-surface area every 3 weeks , plus carboplatin ( dose equivalent to an area under the curve [ AUC ] of 6 ) for six cycles or paclitaxel , administered weekly at a dose of 80 mg per square meter , plus carboplatin ( AUC , 6 ) for six cycles . The primary end point was progression-free survival . RESULTS A total of 692 patients were enrolled , 84 % of whom opted to receive bevacizumab . In the intention-to-treat analysis , weekly paclitaxel was not associated with longer progression-free survival than paclitaxel administered every 3 weeks ( 14.7 months and 14.0 months , respectively ; hazard ratio for disease progression or death , 0.89 ; 95 % confidence interval [ CI ] , 0.74 to 1.06 ; P=0.18 ) . Among patients who did not receive bevacizumab , weekly paclitaxel was associated with progression-free survival that was 3.9 months longer than that observed with paclitaxel administered every 3 weeks ( 14.2 vs. 10.3 months ; hazard ratio , 0.62 ; 95 % CI , 0.40 to 0.95 ; P=0.03 ) . However , among patients who received bevacizumab , weekly paclitaxel did not significantly prolong progression-free survival , as compared with paclitaxel administered every 3 weeks ( 14.9 months and 14.7 months , respectively ; hazard ratio , 0.99 ; 95 % CI , 0.83 to 1.20 ; P=0.60 ) . A test for interaction that assessed homogeneity of the treatment effect showed a significant difference between treatment with bevacizumab and without bevacizumab ( P=0.047 ) . Patients who received weekly paclitaxel had a higher rate of grade 3 or 4 anemia than did those who received paclitaxel every 3 weeks ( 36 % vs. 16 % ) , as well as a higher rate of grade 2 to 4 sensory neuropathy ( 26 % vs. 18 % ) ; however , they had a lower rate of grade 3 or 4 neutropenia ( 72 % vs. 83 % ) . CONCLUSIONS Overall , weekly paclitaxel , as compared with paclitaxel administered every 3 weeks , did not prolong progression-free survival among patients with ovarian cancer . ( Funded by the National Cancer Institute and Genentech ; GOG-0262 Clinical Trials.gov number , NCT01167712 . )",
"OBJECTIVE To assess the ability of preoperative computed tomography ( CT ) scan of the abdomen/pelvis and serum CA-125 to predict suboptimal ( > 1 cm residual disease ) primary cytoreduction in advanced ovarian , fallopian tube , and peritoneal cancer . METHODS This was a prospect i ve , non-r and omized , multicenter trial of patients who underwent primary cytoreduction for stage III-IV ovarian , fallopian tube , and peritoneal cancer . A CT scan of the abdomen/pelvis and serum CA-125 were obtained within 35 and 14 days before surgery , respectively . Four clinical and 20 radiologic criteria were assessed . RESULTS From 7/2001 to 12/2012 , 669 patients were enrolled ; 350 met eligibility criteria . The optimal debulking rate was 75 % . On multivariate analysis , three clinical and six radiologic criteria were significantly associated with suboptimal debulking : age ≥ 60 years ( p=0.01 ) ; CA-125 ≥ 500 U/mL ( p 1 cm ( p diffuse small bowel adhesions/thickening ( p 1 cm in the small bowel mesentery ( p=0.03 ) , root of the superior mesenteric artery ( p=0.003 ) , perisplenic area ( p the suboptimal debulking rates of patients who had a total score of 0 , 1 - 2 , 3 - 4 , 5 - 6 , 7 - 8 , and ≥ 9 were 5 % , 10 % , 17 % , 34 % , 52 % , and 74 % , respectively . A prognostic model combining these nine factors had a predictive accuracy of 0.758 . CONCLUSIONS We identified nine criteria associated with suboptimal cytoreduction , and developed a predictive model in which the suboptimal rate was directly proportional to a predictive value score . These results may be helpful in pretreatment patient assessment",
"BACKGROUND To investigate whether biomarkers consisting of baseline characteristics of advanced stage ovarian cancer patients can help in identifying subgroups of patients who would benefit more from primary surgery or neoadjuvant chemotherapy . METHODS We used data of the European Organisation for Research and Treatment of Cancer ( EORTC ) 55971 trial in which 670 patients were r and omly assigned to primary surgery or neoadjuvant chemotherapy . The primary outcome was overall survival . Ten baseline clinical and pathological characteristics were selected as potential biomarkers . Using Sub population Treatment Effect Pattern Plots ( STEPP ) , biomarkers with a statistically significant qualitative additive interaction with treatment were considered as potentially informative for treatment selection . We also combined selected biomarkers to form a multimarker treatment selection rule . FINDINGS The size of the largest metastatic tumour and clinical stage were significantly associated with the magnitude of the benefit from treatment , in terms of five-year survival ( p for interaction : 0.008 and 0.016 , respectively ) . Stage IIIC patients with metastatic tumours ⩽45 mm benefited more from primary surgery while stage IV patients with metastatic tumours > 45 mm benefited more from neoadjuvant chemotherapy . In stage IIIC patients with larger metastatic tumours and in stage IV patients with less extensive metastatic tumours both treatments were equally effective . We estimated that by selecting treatments for patients based on largest metastatic tumour and clinical stage , the potential five-year survival rate in the population of treated patients would be 27.3 % ( 95 % confidence interval ( CI ) 21.9 - 33.0 ) , 7.8 % higher than if all were treated with primary surgery , and 5.6 % higher if all were treated with neoadjuvant chemotherapy . INTERPRETATION Although survival was comparable after primary surgery and neoadjuvant chemotherapy in the overall group of patients with ovarian cancer in the EORTC 55971 trial , we found in this exploratory analysis that patients with stage IIIC and less extensive metastatic tumours had higher survival with primary surgery , while patients with stage IV disease and large metastatic tumours had higher survival with neoadjuvant chemotherapy . For patients who did not meet these criteria , both treatment options led to comparable survival rates "
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Background Infantile colic is a distressing condition characterised by excessive crying in the first few months of life . The aim of this research was to up date the synthesis of evidence of complementary and alternative medicine ( CAM ) research literature on infantile colic and establish what evidence is currently available . Methods Medline , Embase and AMED ( via Ovid ) , Web of Science and Central via Cochrane library were search ed from their inception to September 2018 . Google Scholar and OpenGrey were search ed for grey literature and PROSPERO for ongoing review s. Published systematic review s that included r and omised controlled trials ( RCTs ) of infants aged up to 1 year , diagnosed with infantile colic using st and ard diagnostic criteria , were eligible . Review s of RCTs that assessed the effectiveness of any individual CAM therapy were included . Three review ers were involved in data extraction and quality assessment using the AMSTAR-2 scale and risk of bias using the ROBIS tool . Results Sixteen systematic review s were identified . Probiotics , fennel extract and spinal manipulation show promise to alleviate symptoms of colic , although some concerns remain . Acupuncture and soy are currently not recommended . The majority of the review s were assessed as having high or unclear risk of bias and low confidence in the findings . Conclusion There is clearly a need for larger and more method ologically sound RCTs to be conducted on the effectiveness of some CAM therapies for IC . Particular focus on probiotics in non-breastfed infants is pertinent . Systematic review registration PROSPERO : CRD42018092966
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"OBJECTIVE To determine whether administration of Lactobacillus reuteri ( L reuteri ) DSM 17938 is beneficial in breastfed infants with infantile colic . STUDY DESIGN Eighty infants aged 50 % ) breastfed were r and omly assigned to receive L reuteri DSM 17938 ( 10(8 ) colony-forming units ) ( n = 40 ) or an identically appearing and tasting placebo ( n = 40 ) , both orally , in 5 drops , 1 time daily , for 21 days . The primary outcome measures were the treatment success , defined as the percentage of children achieving a reduction in the daily average crying time ≥ 50 % , and the duration of crying ( minutes per day ) at 7 , 14 , 21 , and 28 days after r and omization . RESULTS The rate of responders to treatment was significantly higher in the probiotic group compared with the placebo group at day 7 ( P = .026 ) , at day 14 ( relative risk ( RR ) 4.3 , 95 % CI 2.3 - 8.7 ) , at day 21 ( RR 2.7 , 95 % CI 1.85 - 4.1 ) , and at day 28 ( RR 2.5 , 95 % CI 1.8 - 3.75 ) . In addition , throughout the study period , the median crying time was significantly reduced in the probiotic group compared with the control group . CONCLUSION Exclusively or predominantly breastfed infants with infantile colic benefit from the administration of L reuteri DSM 17938 compared with placebo",
"Because infants with colic appear to have abdominal pain similar to that of adults with irritable bowel syndrome , who may benefit from the addition of fiber to their diet , we tested whether fiber added to infant formula would alleviate colic . Twenty-seven normal , term infants ( aged 2 to 8 weeks ; 14 girls ) with colic , defined as crying plus fussing for more than 3 hours a day for at least 3 days of a 6-day baseline period , were enrolled . Infants were r and omly assigned in 9-day periods to a sequence of placebo ( Isomil formula ) followed by fiber-supplemented formula ( Isomil plus soy polysaccharide ) ( n = 12 ) or the reverse ( n = 15 ) . Daily diaries of crying , fussing , sleeping , formula , intake , and stooling were kept . Twenty-two infants completed three lactulose breath hydrogen tests at the end of the baseline period and after each study period . The crossover trial was followed by 30 to 35 days of use of the study formula chosen by the parents as most beneficial but unknown to the investigators . Growth was monitored throughout . Serum cholesterol , calcium , phosphate , albumin , iron , and zinc concentrations were measured at the conclusion . There were no significant differences in average daily time spent by the infants in fussing and crying during ingestion of the fiber-supplemented formula . However , parents of 18 of 27 infants chose fiber-supplemented formula as most beneficial in ameliorating symptoms of colic . While the infants were consuming fiber-supplemented formula , stool frequency increased , and breath hydrogen excretion increased significantly , in response to lactulose . Growth and serum biochemical measurements were normal in all infants . Supplementation of infant formula with the level of soy polysaccharide used in this study may have reduced crying and fussing in some infants but did not affect colicky behavior in the majority of infants , who continued to cry and fuss excessively",
"AIM AND OBJECTIVE The aim of the study was to evaluate the effectiveness of massage , sucrose solution , herbal tea or hydrolysed formula , each used individually in the treatment of infantile colic . BACKGROUND The term colic describes a group of symptoms that occur frequently in infants , consisting of paroxysmal abdominal pain and severe crying . Infant colic is of importance for both parents and the community health services that provide families with care , and is therefore an important clinical problem that is amenable to nursing interventions . DESIGN This prospect i ve and r and omised-controlled study involved 175 infants in Turkey . METHODS Data were gathered by using Wessel criteria ; parents wrote a daily structured diary , recording the onset and duration of crying . Patients were assigned r and omly into four different intervention groups ( massage , sucrose solution , herbal tea and hydrolysed formula ) and control group . Duration of crying following each intervention was recorded in the diary by parents for a one week period . RESULTS There was a significant reduction in crying hours per day in all intervention groups . The difference between mean duration of total crying ( hours/day ) before and after the intervention infants in hydrolysed formula group was found higher than massage , sucrose and herbal tea group . The difference between mean duration of total crying(hours/day ) before and after the intervention infants in massage group was found lower than other intervention groups and all groups . CONCLUSION Our findings demonstrated that varied interventions such as administration of massage , sucrose solution , herbal tea and hydrolysed formula are effective in the treatment of colic . The difference between mean duration of total crying ( hours/day ) before and after the intervention in hydrolysed formula group was found higher than other intervention groups . Hydrolysed formula was the most effective in reducing the duration of crying ( hours/day ) when compared with the other intervention groups . Massage intervention yielded the least symptomatic improvement among all the interventions . RELEVANCE TO CLINICAL PRACTICE Colic treatment models used in this study can be used by nurses in neonatal and primary healthcare setting s as an aid to families for the treatment of infantile colic",
"OBJECTIVE . The goal was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospect i ve r and omized study would improve symptoms of infantile colic . METHODS . Ninety breastfed colicky infants were assigned r and omly to receive either the probiotic L reuteri ( 108 live bacteria per day ) or simethicone ( 60 mg/day ) each day for 28 days . The mothers avoided cow 's milk in their diet . Parents monitored daily crying times and adverse effects by using a question naire . RESULTS . Eighty-three infants completed the trial : 41 in the probiotic group and 42 in the simethicone group . The infants were similar regarding gestational age , birth weight , gender , and crying time at baseline . Daily median crying times in the probiotic and simethicone groups were 159 minutes/day and 177 minutes/day , respectively , on the seventh day and 51 minutes/day and 145 minutes/day on the 28th day . On day 28 , 39 patients ( 95 % ) were responders in the probiotic group and 3 patients ( 7 % ) were responders in the simethicone group . No adverse effects were reported . CONCLUSIONS . In our cohort , L reuteri improved colicky symptoms in breastfed infants within 1 week of treatment , compared with simethicone , which suggests that probiotics may have a role in the treatment of infantile colic",
"The number of published systematic review s of studies of healthcare interventions has increased rapidly and these are used extensively for clinical and policy decisions . Systematic review s are subject to a range of biases and increasingly include non-r and omised studies of interventions . It is important that users can distinguish high quality review s. Many instruments have been design ed to evaluate different aspects of review s , but there are few comprehensive critical appraisal instruments . AMSTAR was developed to evaluate systematic review s of r and omised trials . In this paper , we report on the updating of AMSTAR and its adaptation to enable more detailed assessment of systematic review s that include r and omised or non-r and omised studies of healthcare interventions , or both . With moves to base more decisions on real world observational evidence we believe that AMSTAR 2 will assist decision makers in the identification of high quality systematic review s , including those based on non-r and omised studies of healthcare interventions",
"Context Clinicians rely on systematic review s for current , evidence -based information . Contribution This survival analysis of 100 meta-analyses indexed in ACP Journal Club from 1995 to 2005 found that new evidence that substantively changed conclusions about the effectiveness or harms of therapies arose frequently and within relatively short time periods . The median survival time without substantive new evidence for the meta-analyses was 5.5 years . Significant new evidence was already available for 7 % of the review s at the time of publication and became available for 23 % within 2 years . Implication Clinical ly important evidence that alters conclusions about the effectiveness and harms of treatments can accumulate rapidly . The Editors Systematic review s have become increasingly common in recent years ( 1 ) and are recommended by many as the best sources of evidence to guide both clinical decisions ( 2 ) and health care policy ( 3 ) . For systematic review s to fulfill these roles , their findings must remain relatively stable for at least several years or effective mechanisms must exist for alerting end users to important changes in evidence . Yet , surprisingly little research has assessed the extent to which systematic review s become out of date or the rate at which this occurs ( 47 ) . Some organizations , such as the Cochrane Collaboration , recommend updating systematic review s every 2 years , but few empirical data guide this or other recommendations about updating . We sought to determine how quickly systematic review s meet explicitly defined criteria for changes in evidence of sufficient importance to warrant updating . We also sought to identify predictors of survival time , the time to such important changes in evidence . Survival time might vary depending on many factors , including the type of question posed by the original review ( for example , therapeutic or diagnostic ) , the types of studies included ( for example , r and omized trials or observational studies ) , and whether the systematic review provided quantitative synthesis . To limit such variation , we focused on systematic review s of r and omized , controlled trials that evaluated therapeutic benefit or harm by providing quantitative synthesis ( meta- analysis ) for at least 1 outcome . Methods Study Design and Sample We used a quasi-r and om process ( alphabetical sort order by author ) to select 100 systematic review s that were indexed in ACP Journal Club with an accompanying commentary between January 1995 and December 2005 ( with a search date no later than 31 December 2004 to ensure at least 1 full year for new evidence to appear ) . We chose this sampling frame because ACP Journal Club selects systematic review s that meet explicit quality st and ards and are deemed directly relevant to clinical practice ( 8) . We regarded the sample size of 100 as sufficiently large to achieve suitably narrow confidence intervals and to permit evaluation of up to 5 potential predictors of survival . Eligibility Criteria Eligible review s evaluated the benefit or harm of a specific drug , class of drug , device , or procedure ( invasive procedure or surgery ) and included r and omized or quasi-r and omized , controlled trials . We excluded evaluations of alternative and complementary medicines because the stability of review s of such therapies might differ substantially from review s of conventional therapies . We required that review s provide a point estimate and 95 % confidence interval for at least 1 outcome in the form of a relative risk , odds ratio , or absolute risk difference for binary outcomes and weighted mean differences for continuous outcomes . We excluded meta-analyses of individual-patient data , meta-regressions , and indirect meta-analyses because of the difficulty of determining whether new data would alter previous quantitative results . Two team members independently assessed eligibility , with disagreements resolved by consensus involving a third review er . When more than 1 review on the same topic was identified , only the earliest was included . Search ing For each review , search es for new trials included identifying new systematic review s on the same topic , su bmi tting relevant content terms to the Clinical Queries function in Ovid , applying the Related Articles function in PubMed to the 3 largest and the 3 most recent trials in the original review ( up to 6 trials in total ) , and using Scopus ( www . scopus .com/ scopus /home.url ) to identify new r and omized trials that cited the original review . When these search strategies yielded no eligible new trials , we conducted more comprehensive electronic search es and review ed relevant chapters in such sources as Clinical Evidence and UpTo Date to ensure that we had not missed new trials . Team members who had background s in both medicine and clinical research screened citations retrieved by the preceding methods to identify trials that would have met the inclusion criteria in the original review . Retrieved articles were screened in chronological order to ascertain quantitative or qualitative signals for the need for updating . The review protocol stopped when any criteria for updating were met . Each systematic review was discussed in detail , with the final statussignal for updating was or was not detectedadjudicated by consensus ( Figure 1 ) . Figure 1 . Overall process for determining updating status . ACP Journal Club Signals for the Need to Up date Systematic Review s In design ing criteria for comparing new findings with those in a previous review , we adapted methods used by other investigators to address similar problems with comparing 2 sets of results relating to the same question ( 913 ) , such as r and omized and nonr and omized studies of the same intervention . These investigators identified conflicting findings among different publications using a combination of quantitative thresholds for differences in effect magnitude and qualitative judgments about the language used to describe the results . We have similarly conceptualized quantitative and qualitative signals of potential changes in evidence that are sufficiently important to warrant updating previous systematic review s. Quantitative Signals Quantitative signals consisted of a change in statistical significance or relative change in effect magnitude of at least 50 % . We restricted these changes to those involving 1 of the primary outcomes of the original review or any mortality outcome . We also ignored trivial changes in statistical significance when the original and up date d meta-analytic results both had P values between 0.04 and 0.06so that quantitative signals of changes in evidence would represent robust indicators of the need to up date previous review s. Quantitative signals were detected by combining data from eligible new trials with the previous results using a fixed-effects approach . Use of fixed-effect models allowed pooling of the new trials with the previous meta-analytic result , as opposed to having to obtain original data from all of the included trials in each of 100 systematic review s. Although r and om-effects models are usually preferred to avoid spurious precision in the face of heterogeneity , our goal was to detect potential changes in evidence that would warrant a formal up date , not produce exact estimates of the up date d results . Qualitative Signals Qualitative signals included new information about harm sufficient to affect clinical decision making , important caveats to the original results , emergence of a superior alternate therapy , and important changes in certainty or direction of effect . Qualitative signals were detected by using explicit criteria for comparing the language in the original review with descriptions of findings in new systematic review s that addressed the same topic , pivotal trials , clinical practice guidelines , or recent editions of major textbooks ( for example , UpTo Date ) . Pivotal trials were defined as trials that had a sample size at least 3 times larger than that of the previous largest trial or were published in 1 of the 5 highest-impact general medical journals ( The New Engl and Journal of Medicine , Lancet , Journal of the American Medical Association , Annals of Internal Medicine , and the British Medical Journal ) . We defined 2 levels of importance for qualitative signals : potentially invalidating changes in evidence , which would make one no longer want clinicians or policymakers to base decisions on the original findings ( such as a pivotal trial that characterized treatment effectiveness in terms opposite of those in the original systematic review ) , and major changes in evidence , which would affect clinical decision making in important ways without invalidating the previous results ( such as the identification of patient population s for whom treatment is more or less beneficial ) . Major changes also included differing characterizations of effectiveness that were less extreme than those for potentially invalidating signals but that would still affect clinical decision making ( for example , a change from possibly beneficial to definitely beneficial ) . Of importance , such characterizations as possibly effective , probably effective , and promising , were all categorized as possibly effective . Thus , qualitative signals for changes in evidence captured substantive differences in the characterization of treatment effects , not merely semantic differences . Full definitions for each of the specific signals can be found at www.ohri.ca/UpdatingSystRevs . Data Collection For each review , we characterized the clinical content area , eligibility criteria for included trials , definitions of reported outcomes , number of included trials and participants , meta-analytic result for each outcome , identification of statistical heterogeneity , and excerpted quotations of the authors ' characterizations of the main results . We also abstract ed whether a given outcome was explicitly identified as 1 of the primary or main outcomes . We discounted identification of more than 3 such outcomes as inconsistent with the",
"OBJECTIVE To evaluate the effectiveness of infant massage compared with that of a crib vibrator in the treatment of infantile colic . METHODS Infants infant massage group ( n = 28 ) or a crib vibrator group ( n = 30 ) . Three daily intervention periods were recommended in both groups . Parents recorded infant crying and given interventions in a structured cry diary that was kept for 1 week before ( baseline ) and for 3 weeks during the intervention . Parents were interviewed after the first and third weeks of intervention to obtain their evaluation of the effectiveness of the given massage or crib vibration . RESULTS At baseline , the mean amount of total crying was 3.6 ( st and ard deviation : 1.4 ) hours/day in the massage group infants and 4.2 ( 2.0 ) hours/day in the vibrator group infants . The mean amount of colicky crying was 2.1 ( st and ard deviation : 1.1 ) hours/day and 2.9 ( 1.5 ) hours/day , respectively . The mean number of daily intervention periods was 2.2 in both groups . Over the 4-week study , the amount of total and colicky crying decreased significantly in both intervention groups . The reduction in crying was similar in the study groups : total crying decreased by a mean 48 % in the massage group and by 47 % in the vibrator group , and colicky crying decreased by 64 % and 52 % , respectively . The amount of other crying ( total crying minus colicky crying ) remained stable in both groups over the intervention . Ninety-three percent of the parents in both groups reported that colic symptoms decreased over the 3-week intervention , and 61 % of the parents in the massage group and 63 % of the parents in the crib vibrator group perceived the 3-week intervention as colic reducing . CONCLUSIONS Infant massage was comparable to the use of a crib vibrator in reducing crying in colicky infants . We suggest that the decrease of total and colicky crying in the present study reflects more the natural course of early infant crying and colic than a specific effect of the interventions",
"We evaluated the effect of an herbal tea preparation on infantile colic in a prospect i ve double-blind study . The use of tea eliminated the colic in 19 ( 57 % ) of 33 infants , whereas placebo was helpful in only 9 ( 26 % ) of 35 ( p mean colic score was significantly improved in tea-treated infants . No significant differences were noted between groups regarding number of night wakings",
"Abstract Objective . Infantile colic is a painful condition in the first months of infancy . Acupuncture is used in Sc and inavia as a treatment for infantile colic . A r and omized controlled trial was carried out with the aim of testing the hypothesis that acupuncture treatment has a clinical ly relevant effect for this condition . Design . A prospect i ve , blinding-vali date d , r and omized controlled multicentre trial in general practice . Research assistants and parents were blinded . Setting . 13 GPs ’ offices in Southern Norway . Intervention . Three days of bilateral needling of the acupuncture point ST36 , with no treatment as control . Subjects . 113 patients were recruited ; 23 patients were excluded , and 90 r and omized ; 79 diaries and 84 interviews were analysed . Main outcome measures . Difference in changes in crying time during the trial period between the intervention and control group . Results . The blinding validation questions showed a r and om distribution with p = 0.41 and 0.60 , indicating true blinding . We found no statistically significant difference in crying time reduction between acupuncture and control group at any of the measured intervals , nor in the main analysis of differences in changes over time ( p = 0.26 ) . There was a tendency in favour of the acupuncture group , with a non-significant total baseline-corrected mean of 13 minutes ( 95 % CI –24 to + 51 ) difference in crying time between the groups . This was not considered clinical ly relevant , according to protocol . Conclusion . This trial of acupuncture treatment for infantile colic showed no statistically significant or clinical ly relevant effect . With the current evidence , the authors suggest that acupuncture for infantile colic should be restricted to clinical trials",
"OBJECTIVE To determine whether there is a short-term effect of spinal manipulation in the treatment of infantile colic . DESIGN A r and omized controlled trial . SETTING A private chiropractic practice and the National Health Service 's health visitor nurses in the suburb Ballerup ( Copenhagen , Denmark ) . SUBJECTS Infants seen by the health visitor nurses , who fulfilled the diagnostic criteria for infantile colic . INTERVENTION One group received spinal manipulation for 2 weeks , the other was treated with the drug dimethicone for 2 weeks . OUTCOME MEASURE Changes in daily hours of crying as registered in a colic diary . RESULTS By trial days 4 to 7 , hours of crying were reduced by 1 hour in the dimethicone group compared with 2.4 hours in the manipulation group ( P = .04 ) . On days 8 through 11 , crying was reduced by 1 hour for the dimethicone group , whereas crying in the manipulation group was reduced by 2.7 hours ( P = .004 ) . From trial day 5 onward the manipulation group did significantly better that the dimethicone group . CONCLUSION Spinal manipulation is effective in relieving infantile colic",
"OBJECTIVE To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants , compared with placebo . STUDY DESIGN A r and omized , double-blind , placebo-controlled trial was conducted involving 52 infants with colic , according to modified Wessel criteria , who were assigned at r and om to receive L reuteri DSM 17938 ( 10(8 ) colony-forming units ) ( n = 24 ) or placebo ( n = 28 ) for 21 days . Daily crying and fussing times were recorded in a structured diary , and maternal question naires were completed to monitor changes in infant colic symptoms and adverse events . RESULTS Total average crying and fussing times throughout the study ( from baseline to day 21 ) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group ( 1719 ± 750 minutes [ 29 ± 13 hours ] vs 2195 ± 764 minutes [ 37 ± 13 hours ] ; P = .028 ) ( relative risk , 0.78 ; 95 % CI , 0.58 - 0.98 ) . Infants given L reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo ( median , 60 minutes/day [ IQR , 64 minutes/day ] vs 102 minutes/day [ IQR , 87 minutes/day ] ; P = .045 ) . On day 21 , a significantly higher proportion of infants in the L reuteri DSM 17938 group responded to treatment with a ≥50 % crying time reduction compared with infants given placebo ( 17 vs 6 , P = .035 ; relative risk , 3.3 ; 95 % CI , 1.55 - 7.03 ) . CONCLUSION Administration of L reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic",
"Background . Infantile colic is a distressing and common condition for which there is no proven st and ard treatment . Objective . To compare the efficacy of Mentha piperita with simethicone in treatment for infantile colic . Methods . A double-blind crossover study was performed with 30 infants attending IMIP , Recife , Brazil . They were r and omized to use Mentha piperita or simethicone in the treatment of infantile colic during 7 days with each drug . Primary outcomes were mother_s opinion about responses to the treatment , number of daily episodes of colic , and time spent crying , measured by a chronometer . Mann-Whitney and chi-square tests were used to compare the results . This study was previously approved by the Ethical Committee in Research at IMIP . Results . At baseline daily episodes of infantile colic was 3.9 ( ±1.1 ) and the mean crying time per day was 192 minutes ( ±51.6 ) . At the end of the study daily episodes of colic fell to 1.6 ( ±0.6 ) and the crying duration decreased to 111 ( ±28 ) minutes . All mothers reported decrease of frequency and duration of the episodes of infantile colic and there were no differences between responses to Mentha piperita and simethicone . Conclusions . These findings suggest that Mentha piperita may be used to help control infantile colic . However , these results must be repeated by others studies",
"INTRODUCTION The aim of the study was to investigate and treat infants with colic by conventional medicine followed by an investigation of the effect of reflexological treatment . MATERIAL AND METHODS The investigation was prospect i ve , followed by a r and omised , single-blind , double-controlled , prospect i ve study of reflexological treatment with an interview and diary . Sixty-three infants aged 1 - 3 months referred by general practitioners with crying for > 90 minutes a day were given a paediatric examination and intervention . The cause of crying was discovered in 33 infants : Vitamin D ( 5 ) , elimination of cow 's milk protein ( 3 ) , and anal stenosis ( 3 ) ; counselling on feeding , sleep , reduction of stimulation , and avoidance of passive smoking ( 22 ) . Thirty infants without the benefit of paediatric consultation were r and omised to three groups for a duration of two weeks : A : Presumed non-effective reflexological treatment vs B : Presumed effective reflexological treatment vs C : No treatment -- only observation . The most important parameter was the number of crying hours over 24 hours . Cure was defined as crying for less than or equal to 30 minutes . RESULTS Examination by the paediatrician : Thirty-three of 63 infants benefited with a reduction in crying of less than 90 minutes and 13 of these infants were cured . The r and omised study : In group C ( control ) , none of the patients was cured . In groups A and B ( presumed non-effective reflexological treatment and presumed effective treatment ) , half the patients were cured , which was significantly better than in group C. There was no significant difference between groups A and B , but B seemed better than group A. B was significantly better than C. DISCUSSION Infantile colic had a significant cure rate at paediatric consultation and the children who did not benefit from this intervention had a significantly better outcome after reflexological treatment than had the observation group . Further investigations in reflexological treatment in infants are recommended",
"Acupuncture has been used therapeutically in China for thous and s of years and is growing in prominence in Europe and the United States . In a recent review of complementary and alternative medicine use in the US population , an estimated 2.1 million people or 1.1 % of the population sought acupuncture care during the past 12 months . Four percent of the US population used acupuncture at any time in their lives . We review ed 31 different published journal articles , including 23 r and omized controlled clinical trials and 8 meta- analysis / systematic review s. We found evidence of some efficacy and low risk associated with acupuncture in pediatrics . From all the conditions we review ed , the most extensive research has looked into acupuncture 's role in managing postoperative and chemotherapy-induced nausea/vomiting . Postoperatively , there is far more evidence of acupuncture 's efficacy for pediatrics than for children treated with chemotherapy . Acupuncture seems to be most effective in preventing postoperative induced nausea in children . For adults , research shows that acupuncture can inhibit chemotherapy-related acute vomiting , but conclusions about its effects in pediatrics can not be made on the basis of the available published clinical trials data to date . Besides nausea and vomiting , research conducted in pain has yielded the most convincing results on acupuncture efficacy . Musculoskeletal and cancer-related pain commonly affects children and adults , but unfortunately , mostly adult studies have been conducted thus far . Because the manifestations of pain can be different in children than in adults , data can not be extrapolated from adult research . Systematic review s have shown that existing data often lack adequate control groups and sample sizes . Vas et al , Alimi et al , and Mehling et al demonstrated some relief for adults treated with acupuncture but we could not find any well-conducted r and omized controlled studies that looked at pediatrics and acupuncture exclusively . Pain is often unresolved from drug therapy , thus there is a need for more studies in this setting . For seasonal allergic rhinitis , we review ed studies conducted by Ng et al and Xue et al in children and adults , respectively . Both population s showed some relief of symptoms through acupuncture , but questions remain about treatment logistics . Additionally , there are limited indications that acupuncture may help cure children afflicted with nocturnal enuresis . Systematic review s show that current published trials have suffered from low trial quality , including small sample sizes . Other areas of pediatric afflictions we review ed that suffer from lack of research include asthma , other neurologic conditions , gastrointestinal disorders , and addiction . Acupuncture has become a dominant complementary and alternative modality in clinical practice today , but its associated risk has been question ed . The National Institutes of Health Consensus Statement states “ one of the advantages of acupuncture is that the incidence of adverse effects is substantially lower than that of many drugs or other accepted procedures for the same conditions . ” A review of serious adverse events by White et al found the risk of a major complication occurring to have an incidence between 1:10,000 and 1:100,000 , which is considered “ very low . ” Another study found that the risk of a serious adverse event occurring from acupuncture therapy is the same as taking penicillin . The safety of acupuncture is a serious concern , particularly in pediatrics . Because acupuncture 's mechanism is not known , the use of needles in children becomes question able . For example , acupoints on the vertex of infants should not be needled when the fontanel is not closed . It is also advisable to apply few needles or delay treatment to the children who have overeaten , are overfatigued , or are very weak . Through our review of pediatric adverse events , we found a 1.55 risk of adverse events occurring in 100 treatments of acupuncture that coincides with the low risk detailed in the studies mentioned previously . The actual risk to an individual patient is hard to determine because certain patients , such as an immunosuppressed patient , can be predisposed to an increased risk , acupuncturist 's qualifications differ , and practice s vary in certain parts of the world . Nevertheless , it seems acupuncture is a safe complementary/alternative medicine modality for pediatric patients on the basis of the data we review ed",
"Infant colic , excessive crying of unknown cause , is a major burden to families and effects about 10–30 % of infants . Despite decades of research , the exact cause and treatment of infant colic has remained elusive . The use of Lactobacillus reuteri ( DSM 17938 ) in infant colic is somewhat controversial and hence , we design ed this study to evaluate its efficacy in infantile colic . We recruited predominantly or exclusively breastfed infants , aged less than 4 months in a placebo controlled observational r and omized study . Participants ’ were assigned to receive L. reuteri at a dose 108 colony forming units ( n = 21 ) and placebo ( n = 21 ) . Placebo was an identical formulation without live micro-organisms . Treatment was given to subjects for 21 days and they were followed for 4 weeks . Treatment success ( primary outcome ) , daily reduction in crying time , parent satisfaction and reduction in maternal depression ( secondary outcomes ) were assessed at the end of study period . Treatment success was observed in all infants ( 100 % ) of the probiotic group while it was seen in 15.7 % of the placebo group . Mean daily crying time was more significantly reduced to 32.1 ± 8.3 min/day ( P period , parent ’s satisfaction and improvement in maternal depression ( Edinburgh postnatal depression scale ) was also significantly higher in the probiotic group . In our study population , reduction in crying time was significant ( P reduces daily crying time and maternal depression during infantile colic . We suggest L. reuteri may be a safe and efficacious option for reducing infant colic",
"Objective To analyze the global microbial composition , using large-scale DNA sequencing of 16 S rRNA genes , in faecal sample s from colicky infants given L. reuteri DSM 17938 or placebo . Methods Twenty-nine colicky infants ( age 10–60 days ) were enrolled and r and omly assigned to receive either Lactobacillus reuteri ( 108 cfu ) or a placebo once daily for 21 days . Responders were defined as subjects with a decrease of 50 % in daily crying time at day 21 compared with the starting point . The microbiota of faecal sample s from day 1 and 21 were analyzed using 454 pyrosequencing . The primers : Bakt_341F and Bakt_805R , complemented with 454 adapters and sample specific barcodes were used for PCR amplification of the 16 S rRNA genes . The structure of the data was explored by using permutational multivariate analysis of variance and effects of different variables were visualized with ordination analysis . Results The infants ’ faecal microbiota were composed of Proteobacteria , Firmicutes , Actinobacteria and Bacteroidetes as the four main phyla . The composition of the microbiota in infants with colic had very high inter-individual variability with Firmicutes/Bacteroidetes ratios varying from 4000 to 0.025 . On an individual basis , the microbiota was , however , relatively stable over time . Treatment with L. reuteri DSM 17938 did not change the global composition of the microbiota , but when comparing responders with non-responders the group responders had an increased relative abundance of the phyla Bacteroidetes and genus Bacteroides at day 21 compared with day 0 . Furthermore , the phyla composition of the infants at day 21 could be divided into three enterotype groups , dominated by Firmicutes , Bacteroidetes , and Actinobacteria , respectively . Conclusion L. reuteri DSM 17938 did not affect the global composition of the microbiota . However , the increase of Bacteroidetes in the responder infants indicated that a decrease in colicky symptoms was linked to changes of the microbiota . Trial Registration Clinical Trials.gov",
"The possible role of cows milk intolerance in the aetiology of infant colic was evaluated in 19 babies presenting to their health visitor or general practitioner in one town . Over a three week period a st and ard modified cows milk formula was compared with a soya milk formula on a double blind basis . The duration of colic symptoms was significantly reduced during the week on soya milk ( P less than 0.01 ) , with 11 out of 19 babies fulfilling the diagnostic criteria for cows milk intolerance . Four babies whose symptoms failed to improve either spontaneously or with soya milk were given a hydrolysed protein milk with a positive response in two , confirmed by challenge testing . Thus in 13 out of 19 babies ( 68 % ) the symptoms of infant colic resolved almost completely with dietary change",
"In this open , controlled , prospect i ve study , 28 infants with colic were r and omized to either cranial osteopathic manipulation or no treatment ; all were seen once weekly for 4 weeks . Treatment was according to individual findings , and administered by the same practitioner . Parents recorded time spent crying , sleeping and being held/rocked on a 24-hour diary . A progressive , highly significant reduction between weeks 1 and 4 in crying ( hours/24h ) was detected ( P time spent sleeping ( P no significant differences were detected in these variables for the control group . Overall decline in crying was 63 % and 23 % , respectively , for treated and controls ; improvement in sleeping was 11 % and 2 % . Treated infants also required less parental attention than the untreated group . In conclusion , this preliminary study suggests that cranial osteopathic treatment can benefit infants with colic ; a larger , double-blind study is warranted",
"AIMS To investigate the efficacy of chiropractic spinal manipulation in the management of infantile colic . METHODS One hundred infants with typical colicky pain were recruited to a r and omised , blinded , placebo controlled clinical trial . RESULTS Nine infants were excluded because inclusion criteria were not met , and five dropped out , leaving 86 who completed the study . There was no significant effect of chiropractic spinal manipulation . Thirty two of 46 infants in the treatment group ( 69.9 % ) , and 24 of 40 in the control group ( 60.0 % ) , showed some degree of improvement . CONCLUSION Chiropractic spinal manipulation is no more effective than placebo in the treatment of infantile colic . This study emphasises the need for placebo controlled and blinded studies when investigating alternative methods to treat unpredictable conditions such as infantile colic",
"BACKGROUND Safe and effective treatment of infantile colic ( IC ) has not yet been determined . In this study , the authors aim ed to investigate the efficiency of 30 % glucose solution in the treatment of IC . METHODS A total of 25 infants diagnosed as typical IC were given 1 mL of 30 % glucose solution or sterile water for 4 days consecutively , in a r and omized , double blind crossover trial . The effect was measured by parents ' scoring . RESULTS Parents reported varying degrees of improvement in 16 infants ( 64 % ) given glucose solution , and in 12 infants ( 48 % ) given placebo . Comparison of treatment modalities were statistically significant ( P = 0.031 ) . There was no side-effect during treatments . CONCLUSION The present study revealed that 30 % glucose was effective in the treatment of IC . Since oral glucose solution is natural , safe , cheap and easily achievable , it might be considered as an alternative therapy",
"CONTEXT Despite its benign , natural course , colic is a significant problem in infants and imparts a psychological , emotional , and physical burden to parents . Dicyclomine hydrochloride is the only pharmacological treatment for infantile colic that has been consistently effective . Unfortunately , 5 % of infants treated with dicyclomine hydrochloride develop serious side effects , including death . Fennel seed oil has been shown to reduce intestinal spasms and increase motility of the small intestine . However , there have not been any clinical studies of its effectiveness . OBJECTIVES To determine the effectiveness of fennel seed oil emulsion in infantile colic . DESIGN R and omized placebo-controlled trial . SETTING S Two large multi-specialty clinics . SUBJECTS 125 infants , 2 to 12 weeks of age , who met definition of colic . INTERVENTION Fennel seed oil emulsion compared with placebo . OUTCOME MEASURE Relief of colic symptoms , which was defined as decrease of cumulative crying to less than 9 hours per week . RESULTS The use of fennel oil emulsion eliminated colic , according to the Wessel criteria , in 65 % ( 40/62 ) of infants in the treatment group , which was significantly better than 23.7 % ( 14/59 ) of infants in the control group ( P colic in the treatment group compared with the control group [ Absolute Risk Reduction ( ARR ) = 41 % ( 95 % CI 25 to 57 ) , Number Needed to Treat ( NNT ) = 2 ( 95 % CI 2 to 4 ) ] . Side effects were not reported for infants in either group during the trial . CONCLUSION Our study suggests that fennel seed oil emulsion is superior to placebo in decreasing intensity of infantile colic",
"Background : Probiotic Lactobacillus reuteri and reduced allergen load may lessen the daily crying of colic infants , but the role of Lactobacillus rhamnosus GG ( LGG ) has remained obscure . Methods : Infants with colic ( n = 30 ) were enrolled during the first 6 wk of life . All families received behavioral support and allergen avoidance diet : breastfeeding mothers followed cow ’s milk elimination diet and formula-fed infants received extensively hydrolyzed casein formula . The r and omized , double-blind intervention employed of LGG 4.5 × 109 cfu/d or placebo for a 4-wk study period . Daily crying was recorded by diaries and parental interviews . Fecal calprotectin and gut microbiota composition by quantitative PCR were evaluated before and after the intervention . Results : Daily crying time was comparable between the probiotic ( 173 min ) and the placebo group ( 174 min ; P = 0.99 ) at the end of the intervention according to the parental diary . However , parents reported a decrease of 68 % ( 95 % confidence interval ( CI ) : 58–78 ) in daily crying in the probiotic and 49 % ( 95 % CI : 32–66 ) in the placebo group ( P = 0.05 ) . Conclusion : LGG in infants treated in t and em with behavioral support and a cow ’s milk elimination diet did not provide additional treatment effect for diary-verified colic crying although parental report of crying suggested the probiotic intervention effective",
"AIMS To examine if sucrose has an analgesic effect on infant colic . METHODS Nineteen infants with typical infant colic were given 2 ml of 12 % sucrose or distilled water when crying , in a double blind double crossover study . The effect was measured by parents ’ score . RESULTS Twelve improved specifically on sucrose and one on placebo ( p non-specific improvement . CONCLUSIONS Sucrose has a significant ameliorating effect on infant colic",
"Background Evidence for treating infantile colic with acupuncture is contradictory . Aim To evaluate and compare the effect of two types of acupuncture versus no acupuncture in infants with colic in public child health centres ( CHCs ) . Methods A multicentre , r and omised controlled , single-blind , three-armed trial ( ACU-COL ) comparing two styles of acupuncture with no acupuncture , as an adjunct to st and ard care , was conducted . Among 426 infants whose parents sought help for colic and registered their child 's fussing/crying in a diary , 157 fulfilled the criteria for colic and 147 started the intervention . All infants received usual care plus four extra visits to CHCs with advice/support ( twice a week for 2 weeks ) , comprising gold st and ard care . The infants were r and omly allocated to three groups : ( A ) st and ardised minimal acupuncture at LI4 ; ( B ) semi-st and ardised individual acupuncture inspired by Traditional Chinese Medicine ; and ( C ) no acupuncture . The CHC nurses and parents were blinded . Acupuncture was given by nurses with extensive experience of acupuncture . Results The effect of the two types of acupuncture was similar and both were superior to gold st and ard care alone . Relative to baseline , there was a greater relative reduction in time spent crying and colicky crying by the second intervention week ( p=0.050 ) and follow-up period ( p=0.031 ) , respectively , in infants receiving either type of acupuncture . More infants receiving acupuncture cried , and thereby no longer fulfilled criteria for colic , in the first ( p=0.040 ) and second ( p=0.006 ) intervention weeks . No serious adverse events were reported . Conclusions Acupuncture appears to reduce crying in infants with colic safely . Trial registration number NCT01761331 ; Results",
"OBJECTIVE The aim of this r and omized , double-blind , placebo-controlled trial was to investigate the effectiveness and side effects of a phytotherapeutic agent with Matricariae recutita , Foeniculum vulgare and Melissa officinalis in the treatment of infantile colic . METHODS 93 breastfed colicky infants were enrolled , the diagnosis was made according to Wessel 's criteria . After a 3 day observation period , the infants were r and omly divided into two groups , one treated with phytotherapeutic agent ( PA ) and the other with placebo twice a day for 1 week . Crying time and side effects were recorded . RESULTS 88 infants completed the trial : 41 in the PA group and 47 in the control . The daily average crying time for the PA was 201.2 min/day ( SD 18.3 ) at the baseline and 76.9 min/day ( SD 23.5 ) at the end of the study ; for the placebo it was 198.7 min/day ( SD 16.9 ) and 169.9 min/day ( SD 23.1 ) ( p Crying time reduction was observed in 85.4 % subjects for the PA and in 48.9 % subjects for the placebo ( p side effects were reported . CONCLUSION The present study shows that colic in breastfed infant improves within 1 week of treatment with an extract based on Matricariae recutita , Foeniculum vulgare and Melissa officinalis",
"AIM Infant colic is a frequent problem affecting up to 10 - 30 % of infants in first 3 months of life . Results from previous trials have shown that manipulation of gut microbiota can lead to symptomatic improvements . In a r and omised clinical trial , we aim ed to determine efficacy of synbiotic in reducing average infant crying time at day 7 and day 30 after starting intervention . METHODS Fifty breastfed infants aged 15 - 120 days with infantile colic r and omly assigned to receive either the synbiotic sachet containing 1 billion CFU of : Lactobacillus casei , L. rhamnosus , Streptococcus thermophilus , Bifidobacterium breve , L. acidophilus , B. infantis , L. bulgaricus and fructooligosacharide ( Protexin Healthcare , Somerset , UK ) , or placebo daily for 30 days . Parents were asked to record details of crying times in a symptoms diary . The primary outcome measure was the treatment success ( reduction in the daily crying time > 50 % ) and the secondary outcome measure was symptom resolution ( reduction in the daily crying time > 90 % ) . RESULTS The treatment success was significantly higher in synbiotic group ( 82.6 % ) compared with placebo ( 35.7 % ) at day 7 ( P treatment success was 87 % and 46 % in synbiotic and placebo group , respectively ( P Symptom resolution was also higher in synbiotic group ( 39 % ) compared with placebo ( 7 % ) at day 7 ( P colic symptoms in comparison with placebo",
"The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials",
"OBJECTIVE The purpose of this study was to determine the efficacy of chiropractic manual therapy for infants with unexplained crying behavior and if there was any effect of parental reporting bias . METHODS Infants with unexplained persistent crying ( infant colic ) were recruited between October 2007 and November 2009 at a chiropractic teaching clinic in the United Kingdom . Infants younger than 8 weeks were r and omized to 1 of 3 groups : ( i ) infant treated , parent aware ; ( ii ) infant treated , parent unaware ; and ( iii ) infant not treated , parent unaware . The primary outcome was a daily crying diary completed by parents over a period of 10 days . Treatments were pragmatic , individualized to examination findings , and consisted of chiropractic manual therapy of the spine . Analysis of covariance was used to investigate differences between groups . RESULTS One hundred four patients were r and omized . In parents blinded to treatment allocation , using 2 or less hours of crying per day to determine a clinical ly significant improvement in crying time , the increased odds of improvement in treated infants compared with those not receiving treatment were statistically significant at day 8 ( adjusted odds ratio [ OR ] , 8.1 ; 95 % confidence interval [ CI ] , 1.4 - 45.0 ) and at day 10 ( adjusted OR , 11.8 ; 95 % CI , 2.1 - 68.3 ) . The number needed to treat was 3 . In contrast , the odds of improvement in treated infants were not significantly different in blinded compared with nonblinded parents ( adjusted ORs , 0.7 [ 95 % CI , 0.2 - 2.0 ] and 0.5 [ 95 % CI , 0.1 - 1.6 ] at days 8 and 10 , respectively ) . CONCLUSIONS In this study , chiropractic manual therapy improved crying behavior in infants with colic . The findings showed that knowledge of treatment by the parent did not appear to contribute to the observed treatment effects in this study . Thus , it is unlikely that observed treatment effect is due to bias on the part of the reporting parent",
"OBJECTIVE : To test the efficacy of Lactobacillus reuteri on infantile colic and to evaluate its relationship to the gut microbiota . STUDY DESIGN : Fifty exclusively breastfed colicky infants , diagnosed according to modified Wessel 's criteria , were r and omly assigned to receive either L reuteri DSM 17 938 ( 108 colony-forming units ) or placebo daily for 21 days . Parental question naires monitored daily crying time and adverse effects . Stool sample s were collected for microbiologic analysis . RESULTS : Forty-six infants ( L reuteri group : 25 ; placebo group : 21 ) completed the trial . Daily crying times in minutes/day ( median [ interquartile range ] ) were 370 ( 120 ) vs 300 ( 150 ) ( P = .127 ) on day 0 and 35.0 ( 85 ) vs 90.0 ( 148 ) ( P = .022 ) on day 21 , in the L reuteri and placebo groups , respectively . Responders ( 50 % reduction in crying time from baseline ) were significantly higher in the L reuteri group versus placebo group on days 7 ( 20 vs 8 ; P = .006 ) , 14 ( 24 vs 13 ; P = .007 ) , and 21 ( 24 vs 15 ; P = .036 ) . During the study , there was a significant increase in fecal lactobacilli ( P = .002 ) and a reduction in fecal Escherichia coli and ammonia in the L reuteri group only ( P = .001 ) . There were no differences in weight gain , stooling frequency , or incidence of constipation or regurgitation between groups , and no adverse events related to the supplementation were observed . CONCLUSION : L. reuteri DSM 17 938 at a dose of 108 colony-forming units per day in early breastfed infants improved symptoms of infantile colic and was well tolerated and safe . Gut microbiota changes induced by the probiotic could be involved in the observed clinical improvement"
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Objective To identify which therapeutic intervention may be most effective for improving self-reported function in patients with chronic ankle instability ( CAI ) . Design Systematic literature review . Articles were appraised using the Downs and Black Checklist by 3 review ers . Data sources PubMed along with CINAHL , MEDLINE and SPORTD iscus within EBSCOhost for pertinent articles from their inception through August 2016 . Eligibility criteria for selected studies Articles included were required to ( 1 ) be written in English , ( 2 ) report adequate data to calculate effect sizes , ( 3 ) identify patients with CAI , ( 4 ) use some form of therapeutic intervention and ( 5 ) use a self-reported question naire as a main outcome measurement . Results A broad spectrum of therapeutic interventions were identified related to balance training , multimodal rehabilitation , joint mobilisation , resistive training , soft-tissue mobilisation , passive calf stretching and orthotics . All of the articles included in the balance training category had moderate-to-strong Hedges g with none of the 95 % CIs crossing 0 . Hedges g effect sizes ranged from −0.67 to −2.31 and −0.51 to −1.43 for activities of daily living and physical activity , respectively . The multimodal rehabilitation category also produced moderate-to-strong Hedges g effect sizes but with large CIs crossing 0 . Hedges g effect sizes ranged from −0.47 to −9.29 and −0.62 to −24.29 for activities of daily living and physical activity , respectively . Conclusions The main findings from this systematic review were balance training provided the most consistent improvements in self-reported function for patients with CAI
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"OBJECTIVE To determine the point prevalence of chronic musculoskeletal ankle disorders in the community . DESIGN Cross-sectional stratified ( metropolitan vs regional ) r and om sample . SETTING General community . PARTICIPANTS Population -based computer-aided telephone survey of people ( N=2078 ) aged 18 to 65 years in New South Wales , Australia . Of those contacted , 751 participants provided data . INTERVENTIONS Not applicable . MAIN OUTCOME MEASURES Point prevalence for no history of ankle injury or chronic ankle problems ( no ankle problems ) , history of ankle injury without residual problems , and chronic ankle disorders . Chronic musculoskeletal ankle disorders due to ankle sprain , fracture , arthritis , or other disorder compared by chi-square test for the presence of pain , weakness , giving way , swelling and instability , activity limitation , and health care use in the past year . RESULTS There were 231 ( 30.8 % ) participants with no ankle problems , 342 ( 45.5 % ) with a history of ankle injury but no chronic problems , and 178 ( 23.7 % ) with chronic ankle disorders . The major component of chronic ankle disorders was musculoskeletal disorders ( n=147 , 19.6 % of the total sample ) , most of which were due to ankle injury ( n=117 , 15.6 % of the total ) . There was no difference among the arthritis , fracture , sprain , and other groups in the prevalence of the specific complaints , or health care use . Significantly more participants with arthritis had to limit activity than in the sprain group ( Chi-square test , P=.035 ) . CONCLUSIONS Chronic musculoskeletal ankle disorders affected almost 20 % of the Australian community . The majority were due to a previous ankle injury , and most people had to limit or change their physical activity because of the ankle disorder",
"CONTEXT Although lateral ankle sprains are common in athletes and can lead to chronic ankle instability ( CAI ) , strength-training rehabilitation protocol s may improve the deficits often associated with CAI . OBJECTIVE To determine whether strength-training protocol s affect strength , dynamic balance , functional performance , and perceived instability in individuals with CAI . DESIGN R and omized controlled trial . SETTING Athletic training research laboratory . PATIENTS OR OTHER PARTICIPANTS A total of 39 individuals with CAI ( 17 men [ 44 % ] , 22 women [ 56 % ] ) participated in this study . Chronic ankle instability was determined by the Identification of Functional Ankle Instability Question naire , and participants were r and omly assigned to a resistance-b and - protocol group ( n = 13 [ 33 % ] age = 19.7 ± 2.2 years , height = 172.9 ± 12.8 cm , weight = 69.1 ± 13.5 kg ) , a proprioceptive neuromuscular facilitation strength- protocol group ( n = 13 [ 33 % ] , age = 18.9 ± 1.3 years , height = 172.5 ± 5.9 cm , weight = 72.7 ± 14.6 kg ) , or a control group ( n = 13 [ 33 % ] , age = 20.5 ± 2.1 years , height = 175.2 ± 8.1 cm , weight = 70.2 ± 11.1 kg ) . INTERVENTION(S ) Both rehabilitation groups completed their protocol s 3 times/wk for 6 weeks . The control group did not attend rehabilitation sessions . MAIN OUTCOME MEASURE(S ) Before the interventions , participants were pretested by completing the figure-8 hop test for time , the triple-crossover hop test for distance , isometric strength tests ( dorsiflexion , plantar flexion , inversion , and eversion ) , the Y-Balance test , and the visual analog scale for perceived ankle instability . Participants were again tested 6 weeks later . We conducted 2 separate , multivariate , repeated- measures analyses of variance , followed by univariate analyses on any significant findings . RESULTS The resistance-b and protocol group improved in strength ( dorsiflexion , inversion , and eversion ) and on the visual analog scale ( P improved in strength ( inversion and eversion ) and on the visual analog scale ( P the triple-crossover hop or the Y-Balance tests for either intervention group or in the control group for any dependent variable ( P > .05 ) . CONCLUSIONS Although the resistance-b and protocol is common in rehabilitation , the proprioceptive neuromuscular facilitation strength protocol is also an effective treatment to improve strength in individuals with CAI . Both protocol s showed clinical benefits in strength and perceived instability . To improve functional outcomes , clinicians should consider using additional multiplanar and multijoint exercises",
"BACKGROUND AND PURPOSE Passive joint mobilization is commonly used by physical therapists as an intervention for acute ankle inversion sprains . A r and omized controlled trial with blinded assessors was conducted to investigate the effect of a specific joint mobilization , the anteroposterior glide on the talus , on increasing pain-free dorsiflexion and 3 gait variables : stride speed ( gait speed ) , step length , and single support time . SUBJECTS Forty-one subjects with acute ankle inversion sprains ( entered the trial . METHODS Subjects were r and omly assigned to 1 of 2 treatment groups . The control group received a protocol of rest , ice , compression , and elevation ( RICE ) . The experimental group received the anteroposterior mobilization , using a force that avoided incurring any increase in pain , in addition to the RICE protocol . Subjects in both groups were treated every second day for a maximum of 2 weeks or until the discharge criteria were met , and all subjects were given a home program of continued RICE application . Outcomes were measured before and after each treatment . RESULTS The results showed that the experimental group required fewer treatment sessions than the control group to achieve full pain-free dorsiflexion . The experimental group had greater improvement in range of movement before and after each of the first 3 treatment sessions . The experimental group also had greater increases in stride speed during the first and third treatment sessions . DISCUSSION AND CONCLUSION Addition of a talocrural mobilization to the RICE protocol in the management of ankle inversion injuries necessitated fewer treatments to achieve pain-free dorsiflexion and to improve stride speed more than RICE alone . Improvement in step length symmetry and single support time was similar in both groups",
"STUDY DESIGN Prospect i ve cohort study . OBJECTIVE To assess the effect of 6 weeks of balance training on sensorimotor measures previously found to be deficient in participants with chronic ankle instability ( CAI ) . BACKGROUND CAI is the tendency toward repeated ankle sprains and recurring symptoms , occurring in 40 % to 70 % of individuals who have previously sustained a lateral ankle sprain . Recent studies have found deficits in sensorimotor measures in individuals with CAI . As balance training is a common component of ankle rehabilitation , underst and ing its effect on the sensorimotorsystem in individuals with CAI may enable us to optimize protocol s to better utilize this rehabilitation method . METHODS Twelve participants with CAI and 9 healthy volunteers participated . Independent variables were group ( CAI , control ) and time ( pretraining , posttraining ) . Participants with CAI who completed a 6-week balance training program and healthy controls who did not get any training were pretested and posttested at the beginning and at the end of 6 weeks . RESULTS The individuals in the CAI group who performed balance training demonstrated better performance than control participants on baseline adjusted posttraining measures of dynamic balance in the anterior medial ( P = .021 ) , medial ( P = .048 ) , and posterior medial directions ( P = .030 ) ; motoneuron pool excitability Hmax/Mmax ratio ( P = .044 ) and single-limb presynaptic inhibition ( P = .012 ) ; and joint position sense inversion variable error ( P = .017 ) . It may be of note that no systematic differences were detected for static balance or plantar flexion joint position sense tasks . CONCLUSIONS After 6 weeks of balance training , individuals with CAI demonstrated enhanced dynamic balance , inversion joint position sense , and changes in motoneuron pool excitability compared to healthy controls who did not train . LEVEL OF EVIDENCE Therapy , level 2b",
"Objective : To examine the effects of a four-week balance training programme on ankle kinematics during walking and jogging in those with chronic ankle instability . A secondary objective was to evaluate the effect of balance training on the mechanical properties of the lateral ligaments in those with chronic ankle instability . Design : R and omized controlled trial . Setting : Laboratory . Subjects/ patients : Twenty-nine participants ( 12 males , 17 females ) with self-reported chronic ankle instability were r and omly assigned to a balance training group or a control group . Intervention : Four weeks of supervised rehabilitation that emphasized dynamic balance stabilization in single-limb stance . The control group received no intervention . Main outcome measures : Kinematic measures of rearfoot inversion/eversion , shank rotation , and the coupling relationship between these two segments throughout the gait cycle during walking and jogging on a treadmill . Instrumented ankle arthrometer measures were taken to assess anterior drawer and inversion talar tilt laxity and stiffness . Results : No significant alterations in the inversion/eversion or shank rotation kinematics were found during walking and jogging after balance training . There was , however , a significant decrease in the shank/rearfoot coupling variability during walking as measured by deviation phase after balance training ( balance training posttest : 13.1 ° ± 6.2 ° , balance training pretest : 16.2 ° ± 3.3 ° , P = 0.03 ) , indicating improved shank/rearfoot coupling stability . The control group did not significantly change . ( posttest : 16.30 ° ± 4.4 ° , pretest : 18.6 ° ± 7.1 ° , P40.05 ) There were no significant changes in laxity measures for either group . Conclusions : Balance training significantly altered the relationship between shank rotation and rearfoot inversion/eversion in those with chronic ankle instability",
"OBJECTIVE To determine how gluteus medius ( Gmed ) and maximus ( Gmax ) activate during closed-chain functional rehabilitative exercises in those with and without chronic ankle instability ( CAI ) . DESIGN Cohort study . Subjects performed ten repetitions of a rotational lunge and single-leg rotational squat while surface electromyography was used to collect mean muscle activity of the Gmed and Gmax . MAIN OUTCOME MEASURES Mean electromyography activity of the Gmed and Gmax at maximum excursion was compared between Groups and Exercises using a separate 2-way repeated measures analysis of variance design for each muscle . SETTING University biomechanics lab . PARTICIPANTS Nine healthy ( 8F , 1 M ) and nine CAI subjects ( 8F , 1 M ) RESULTS : For Gmax activation , there was a statistically significant Group by Exercise interaction ( F(3,48 ) = 4.84 , p = 0.043 ) . A Scheffe 's post-hoc test revealed that during the rotational squat , the CAI group had significantly lower Gmax activation ( 51.1 ± 31.0 % ) than the healthy group ( 78.6 ± 44.8 % ) . There were no statistically significant findings for the Gmed . In the healthy group , the Gmax produced significantly higher activation during rotational squat ( 78.6 ± 44.8 % ) compared to the rotational lunge ( 57.6 ± 31.9 % ) . CONCLUSION Because the CAI group had significantly less Gmax activation than the healthy group during the rotational squat at the point of maximum excursion , and because the rotational squat showed significantly higher Gmax activation compared to the rotational lunge , it may be important for clinicians to implement the rotational squat during rehabilitation for those with CAI . Future prospect i ve and intervention research involving hip musculature in those with CAI is recommended",
"The purpose of this study was to compare alterations in peroneal latency and electromechanical delay ( EMD ) following an inversion perturbation during walking in patients with functional ankle instability ( FAI ) and with a matched control group . Peroneal latency and EMD were measured from 21 patients with unilateral FAI and 21 controls . Latencies were collected during a r and om inversion perturbation while walking . EMD measures were collected during stance using a percutaneous stimulus . Two-way ANOVAs were used to detect differences between leg ( affected , unaffected ) and group ( FAI , Control ) . Functionally unstable ankles displayed delayed peroneus longus ( PL ) latencies and EMD when compared to the unaffected leg and a matched control group . Peroneal latency and EMD deficits could contribute to recurrence of ankle injury in FAI subjects . How these deficits are associated with the chronic symptoms associated with FAI remains unclear , but gamma activation and subsequent muscle spindle sensitivity likely play a role",
"STUDY DESIGN A nonr and omized 2-group pretest-posttest design . OBJECTIVES To determine the effects of a 4-week balance training program during stance on a single leg . BACKGROUND Individuals who have experienced multiple episodes of inversion ankle sprains often participate in balance training programs . Balance training is performed to treat existing proprioceptive deficits and to restore ankle joint stability , presumably by retraining altered afferent neuromuscular pathways . The effectiveness of such programs on individuals with functionally unstable ankles has yet to be established . METHODS AND MEASURES Prior to and following training , subjects with self-reported functionally unstable ankles ( 5 women and 8 men , mean age = 21.9 + /- 3.1 years ) and nonimpaired subjects ( 6 women and 7 men , mean age = 21.2 + /- 2.5 years ) completed a static balance assessment for both limbs as well as the ankle joint functional assessment tool question naire ( AJFAT ) . The subjects from both groups participated in a unilateral , multilevel , static and dynamic balance training program 3 times a week for 4 weeks . Subjects from the experimental group trained only the involved limb , and the nonimpaired group trained a r and omly selected limb . A stability index ( SI ) was calculated during the balance assessment to indicate the amount of platform motion . Compared to low stability indices , high stability indices indicate greater platform motion during stance and therefore less stability . RESULTS Following training , subjects from both groups demonstrated significant improvements in balance ability . When balance was assessed at a low resistance to platform tilt ( stability level 2 ) , the posttraining scores of both the subjects with unstable ankles ( mean SI = 2.63 + /- 1.92 ) and the nonimpaired subjects ( mean SI = 2.69 + /- 2.32 ) were significantly better than their pretraining scores ( mean SIs = 5.93 + /- 3.65 and 4.67 + /- 3.43 , respectively ) . Assessed at a high resistance to platform tilt ( stability level 6 ) , the posttraining scores of both subjects with unstable ankles ( mean SI = 1.27 + /- 0.66 ) and the nonimpaired subjects ( mean SI = 1.37 + /- 0.66 ) were significantly better than their pretraining scores ( mean SIs = 2.30 + /- 1.88 and 2.04 + /- 1.43 , respectively ) . Additionally , the posttraining AJFAT scores of subjects with unstable ankles ( 25.78 + /- 3.80 ) and the nonimpaired subjects ( 29.15 + /- 5.27 ) were significantly greater than their pretraining scores ( 17.11 + /- 3.44 and 22.92 + /- 5.22 , respectively ) , indicating an overall improvement in perceived ankle joint functional stability . CONCLUSIONS This study suggests that balance training is an effective means of improving joint proprioception and single-leg st and ing ability in subjects with unstable and nonimpaired ankles",
"The purpose of this study was to examine a young athletic population to up date the data regarding epidemiology and disability associated with ankle injuries . At the United States Military Academy , all cadets presenting with ankle injuries during a 2-month period were included in this prospect i ve observational study . The initial evaluation included an extensive question naire , physical examination , and radiographs . Ankle sprain treatment included a supervised rehabilitation program . Subjects were reevaluated at 6 weeks and 6 months with subjective assessment , physical examination , and functional testing . The mean age for all subjects was 20 years ( range , 17–24 years ) . There were 104 ankle injuries accounting for 23 % of all injuries seen . There were 96 sprains , 7 fractures , and 1 contusion . Of the 96 sprains , 4 were predominately medial injuries , 76 were lateral , and 16 were syndesmosis sprains . Ninety-five percent had returned to sports activities by 6 weeks ; however , 55 % of these subjects reported loss of function or presence of intermittent pain , and 23 % had a decrement of > 20 % in the lateral hop test when compared with the uninjured side . At 6 months , all subjects had returned to full activity ; however , 40 % reported residual symptoms and 2.5 % had a decrement of > 20 % on the lateral hop test . Neither previous injury nor ligament laxity was predictive of chronic symptomatology . Furthermore , chronic dysfunction could not be predicted by the grade of sprain ( grade I vs. II ) . The factor most predictive of residual symptoms was a syndesmosis sprain , regardless of grade . Syndesmosis sprains were most prevalent in collision sports . This study demonstrates that even though our knowledge and underst and ing of ankle sprains and rehabilitation of these injuries have progressed in the last 20 years , chronic ankle dysfunction continues to be a prevalent problem . The early return to sports occurs after almost every ankle sprain ; however , dysfunction persists in 40 % of patients for as long as 6 months after injury . Syndesmosis sprains are more common than previously thought , and this confirms that syndesmosis sprains are associated with prolonged disability",
"CONTEXT A dynamic-balance-training ( DBT ) program supplemented with the Graston instrument-assisted soft-tissue mobilization ( GISTM ) technique has not been evaluated collectively as a treatment in subjects with chronic ankle instability ( CAI ) . OBJECTIVE To examine the effects of GISTM in conjunction with a DBT program on outcomes associated with CAI , including pain and disability , range of motion ( ROM ) , and dynamic postural control . DESIGN Pretest/posttest , repeated measures . SETTING High school and a Division I mid-Atlantic university . PARTICIPANTS Thirty-six healthy , physically active individuals ( 5 female , 31 male ; age 17.7 ± 1.9 y ; height 175.3 ± 14.6 cm ) with a history of CAI as determined by an ankle-instability question naire volunteered to be in this study . INTERVENTIONS Subjects were r and omly assigned to 1 of 3 intervention groups : both treatments ( DBT/GISTM , n = 13 ) , DBT and a sham GISTM treatment ( DBT/GISTM-S , n = 12 ) , or DBT and control-no GISTM ( DBT/C , n = 11 ) . All groups participated in a 4-wk DBT program consisting of low-impact and dynamic activities that was progressed from week to week . The DBT/GISTM and DBT/GISTM-S groups received the GISTM treatment or sham treatment twice a week for 8 min before performing the DBT program . Pretest and posttest measurements included the Foot and Ankle Ability Measure ( FAAM ) , FAAM Sport , the visual analog scale ( VAS ) , ankle ROM in 4 directions , and the Star Excursion Balance Test ( SEBT ) in 3 directions . MAIN OUTCOME MEASURES FAAM and FAAM-Sport scores , VAS , goniometric ROM ( plantar flexion , dorsiflexion , inversion , eversion ) , and SEBT ( anterior , posteromedial , posterolateral ) . RESULTS Subjects in all groups posttest demonstrated an increase in FAAM , FAAM Sport , ROM , and SEBT in all directions but not in VAS , which decreased . No other results were significant . CONCLUSION For subjects with CAI , dynamic postural control , ROM , pain and disability improved pretest to posttest regardless of group membership , with the largest effects found in most measures in the DBT/GISTM group",
"UNLABELLED Despite the high incidence of chronic ankle instability ( CAI ) , the underlying neurophysiologic mechanism is unknown . Evidence suggests that both feed-forward and feedback mechanisms may play a role . However , no investigation has examined both control mechanisms during the same movement task in the same cohort of CAI patients . PURPOSE To determine the neuromuscular and biomechanical control alterations present in CAI patients during planned ( feed-forward ) and unplanned ( feedback ) gait termination . METHODS Twenty subjects with CAI and 20 uninjured controls completed planned and unplanned gait termination protocol s. Both tasks began with subjects walking at a self-selected speed across a 12-m walkway . Unplanned gait termination required subjects to stop during r and omly selected trials on two adjacent force plates when cued . Planned gait termination required purpose ful stopping on the force places . Propulsive and braking force magnitude and the dynamic postural stability index were calculated from the result ing ground reaction forces . In addition , muscle activity from the soleus , tibialis anterior , and gluteus medius was collected bilaterally . RESULTS Both maximum propulsive ( CAI = 99.8 + /- 40.8 N , control = 88.6 + /- 33.6 N ) and braking ( CAI = 207.1 + /- 80.9 N , control = 161.6 + /- 62.2 N ) forces were significantly higher in the CAI group . The dynamic postural stability index revealed higher scores in the CAI group ( 0.24 + /- 0.03 ) compared with the control group ( 0.22 + /- 0.03 ) . Muscle activation of the soleus and tibialis anterior differed during unplanned and planned gait termination between groups ( P biomechanical strategies during both planned and unplanned gait termination indicate that patients with CAI have alterations in feed-forward neuromuscular control and suggest the presence of feedback neuromuscular control deficits",
"Objective . To compare the effects of combined trigger point dry needling ( TrP-DN ) and proprioceptive/strengthening exercises to proprioceptive/strengthening exercises on pain and function in ankle instability . Methods . Twenty-seven ( 44 % female , mean age : 33 ± 3 years ) individuals with unilateral ankle instability were r and omly assigned to an experimental group who received proprioceptive/strengthening exercises combined with TrP-DN into the lateral peroneus muscle and a comparison group receiving the same proprioceptive/strengthening exercise program alone . Outcome included function assessed with the Foot and Ankle Ability Measure ( FAAM ) and ankle pain intensity assessed with a numerical pain rate scale ( NPRS ) . They were captured at baseline and 1-month follow-up after the intervention . Results . The ANOVAs found significant Group ∗ Time Interactions for both subscales of the FAAM ( ADL : F = 8.211 ; P = 0.008 ; SPORTS : F = 13.943 ; P and for pain ( F = 44.420 ; P receiving TrP-DN plus proprioceptive/strengthening exercises experienced greater improvements in function and pain than those receiving the exercise program alone . Between-groups effect sizes were large in all outcomes ( SMD > 2.1 ) in favor of the TrP-DN group . Conclusions . This study provides evidence that the inclusion of TrP-DN within the lateral peroneus muscle into a proprioceptive/strengthening exercise program result ed in better outcomes in pain and function 1 month after the therapy in ankle instability",
"Background Ankle sprains are the most common injuries in a variety of sports . Hypothesis A proprioceptive balance board program is effective for prevention of ankle sprains in volleyball players . Study Design Prospect i ve controlled study . Methods There were 116 male and female volleyball teams followed prospect ively during the 2001 - 2002 season . Teams were r and omized by 4 geographical regions to an intervention group ( 66 teams , 641 players ) and control group ( 50 teams , 486 players ) . Intervention teams followed a prescribed balance board training program ; control teams followed their normal training routine . The coaches recorded exposure on a weekly basis for each player . Injuries were registered by the players within 1 week after onset . Results Significantly fewer ankle sprains in the intervention group were found compared to the control group ( risk difference = 0.4/1000 playing hours ; 95 % confidence interval , 0.1 - 0.7 ) . A significant reduction in ankle sprain risk was found only for players with a history of ankle sprains . The incidence of overuse knee injuries for players with history of knee injury was increased in the intervention group . History of knee injury may be a contraindication for proprioceptive balance board training . Conclusions Use of proprioceptive balance board program is effective for prevention of ankle sprain recurrences",
"STUDY DESIGN Prospect i ve , r and omized controlled trial . OBJECTIVE To examine the effects of a 4-week rehabilitation program for chronic ankle instability ( CAI ) on postural control and lower extremity function . BACKGROUND CAI is associated with residual symptoms , performance deficits , and reinjury . Managing CAI is challenging and more evidence is needed to guide effective treatment . METHODS AND MEASURES Subjects with unilateral CAI were r and omly assigned to the rehabilitation ( CAI-rehab , n=16 ) or control ( CAI-control , n=13 ) group . Subjects without CAI were assigned to a healthy group ( n=19 ) . Baseline testing included the ( 1 ) center of pressure velocity ( COPV ) , ( 2 ) star excursion balance test ( SEBT ) , and ( 3 ) Foot and Ankle Disability index ( FADI ) and FADI-Sports Subscale ( FADI-Sport ) . The CAI-rehab group completed 4 weeks of rehabilitation that addressed range of motion , strength , neuromuscular control , and functional tasks . After 4 weeks , all subjects were retested . Nonparametric analyses for group differences and between-group comparisons were performed . RESULTS Subjects with CAI demonstrated deficits in postural control and SEBT reach tasks of the involved limb compared to the uninvolved limb and reported functional deficits of the involved limb compared to healthy subjects . Following rehabilitation , the CAI-rehab group had greater SEBT reach improvements on the involved limb than the other groups and greater improvements in FADi and FADI-Sport scores . CONCLUSIONS These results demonstrate postural control and functional limitations exist in individuals with CAl . In addition , rehabilitation appears to improve these functional limitations . Finally , there is evidence to suggest the SEBT may be a good functional measure to monitor change after rehabilitation for CAI",
"OBJECTIVE To examine the effects of ankle-strengthening exercises on joint position sense and strength development in subjects with functionally unstable ankles . DESIGN AND SETTING Subjects were r and omly assigned to a training or control group . The training group participated in a 6-week strength-training protocol using rubber tubing 3 times a week throughout the training period . The control group did not participate in the strength-training protocol . SUBJECTS Twenty healthy college students ( 10 females , 10 males , age = 20.6 + /- 2.23 years ; ht = 176.40 + /- 7.14 cm ; wt = 74.18 + /- 10.17 kg ) with a history of functional ankle instability volunteered to participate in this study . MEASUREMENTS We pretested and posttested dorsiflexor and evertor isometric strength with a h and held dynamometer and collected joint position sense ( JPS ) data at 20 degrees for inversion and plantar flexion and at 10 degrees for eversion and dorsiflexion . RESULTS Statistical tests for strength and JPS revealed significant group-by-time interactions for dorsiflexion strength , eversion strength , inversion JPS , and plantar flexion JPS . Simple main-effects testing revealed improvements in training group strength and JPS at posttesting . There were no significant effects for eversion JPS , but the group main effect for dorsiflexion JPS was significant , with the experimental group having better scores than the control group . CONCLUSIONS Ankle-strengthening exercises improved strength , inversion JPS , dorsiflexion JPS , and plantar flexion JPS in subjects with functionally unstable ankles",
"The purpose of this study was to examine the effects of a single joint mobilization treatment on dorsiflexion range of motion ( DF ROM ) , posterior talar glide , and dynamic and static postural control in individuals with self-reported chronic ankle instability ( CAI ) . In this r and omized cross-over study , subjects received a Maitl and Grade III anterior-to-posterior joint mobilization treatment and a control treatment of rest for 5 min . Weight-bearing DF ROM , instrumented posterior talar displacement and posterior stiffness , the anterior , posteromedial , and posterolateral reach directions of the Star Excursion Balance Test ( SEBT ) , and time-to-boundary ( TTB ) single-limb stance static postural control were assessed on both treatment days in 9 males and 11 females with CAI . The results indicated that the joint mobilization treatment was associated with significantly greater DF ROM ( p = 0.01 ) and TTB in the anterior-posterior direction with eyes-open ( p posterior talar displacement ( p = 0.08 ) and the mean of TTB in the medial-lateral ( ML ) direction ( p = 0.07 ) . No significant differences were observed in the st and ard deviation of TTB in the ML direction , the SEBT , or posterior stiffness ( p > 0.05 ) . This indicates that a single joint mobilization treatment has mechanical and functional benefits for addressing impairments in sensorimotor function and arthrokinematic restrictions commonly experienced by individuals with CAI",
"OBJECTIVE The purpose of this study was to compare manipulative therapy ( MT ) plus rehabilitation to rehabilitation alone for recurrent ankle sprain with functional instability ( RASFI ) to determine short-term outcomes . METHODS This was an assessor-blind , parallel-group r and omized comparative trial . Thirty-three eligible participants with RASFI were r and omly allocated to receive rehabilitation alone or chiropractic MT plus rehabilitation . All participants undertook a daily rehabilitation program over the course of the 4-week treatment period . The participants receiving MT had 6 treatments over the same treatment period . The primary outcome measures were the Foot and Ankle Disability Index and the visual analogue pain scale , with the secondary outcome measure being joint motion palpation . Data were collected at baseline and during week 5 . Missing scores were replaced using a multiple imputation method . Statistical analysis of the data composed of repeated- measures analysis of variance . RESULTS Between-group analysis demonstrated a difference in scores at the final consultation for the visual analogue scale and frequency of joint motion restrictions ( P ≤ .006 ) but not for the Foot and Ankle Disability Index ( P = .26 ) . CONCLUSIONS This study showed that the patients with RASFI who received chiropractic MT plus rehabilitation showed significant short-term reduction in pain and the number of joint restrictions in the short-term but not disability when compared with rehabilitation alone",
"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",
"The aim of this study was to investigate motor control in subjects with functional instability of the ankle joint . This was achieved by analysing patterns of lower extremity motion prior to and immediately following l and ing during single leg jumping in subjects with functional instability of the ankle . Fourteen subjects with unilateral functional instability and 10 healthy control subjects performed single leg jumps from a 40 cm height whilst angular displacement of their ankle and knee joints were recorded . Subjects with functional instability demonstrated significantly greater ankle dorsiflexion over the period encompassing 10 ms pre l and ing to 20 ms post l and ing ( p greater level of knee flexion than controls over the period from 20 ms pre l and ing to 60 ms post l and ing ( p < 0.05 ) . The timing of these significant differences leads us to conclude that they do not arise as a result of reflexively mediated peripheral events following l and ing",
"We examined the effect of a 2-week anterior-to-posterior ankle joint mobilization intervention on weight-bearing dorsiflexion range of motion ( ROM ) , dynamic balance , and self-reported function in subjects with chronic ankle instability ( CAI ) . In this prospect i ve cohort study , subjects received six Maitl and Grade III anterior-to-posterior joint mobilization treatments over 2 weeks . Weight-bearing dorsiflexion ROM , the anterior , posteromedial , and posterolateral reach directions of the Star Excursion Balance Test ( SEBT ) , and self-reported function on the Foot and Ankle Ability Measure ( FAAM ) were assessed 1 week before the intervention ( baseline ) , prior to the first treatment ( pre-intervention ) , 24 - 48 h following the final treatment ( post-intervention ) , and 1 week later ( 1-week follow-up ) in 12 adults ( 6 males and 6 females ) with CAI . The results indicate that dorsiflexion ROM , reach distance in all directions of the SEBT , and the FAAM improved ( p 0.05 ) . These results indicate that the joint mobilization intervention that targeted posterior talar glide was able to improve measures of function in adults with CAI for at least 1 week",
"Abstract Purpose : To evaluate the effects of joint mobilization , in which movement is applied to the ankle 's dorsiflexion range of motion , on dynamic postural control and on the self-reported instability of patients with chronic ankle instability ( CAI ) . Methods : A double-blind , placebo-controlled , r and omized trial with repeated measures and a follow-up period . Ninety patients with a history of recurrent ankle sprain , self-reported instability , and a limited dorsiflexion range of motion , were r and omly assigned to either the intervention group ( Joint Mobilizations , 3 weeks , two sessions per week ) the placebo group ( Sham Mobilizations , same duration as joint mobilization ) or the control group , with a 6 months follow-up . Dorsiflexion Range of Motion ( DFROM ) , Star Excursion Balance Test ( SEBT ) and CAI Tool ( CAIT ) were outcome measures . A separate 3 × 4 mixed model analysis of variance was performed to examine the effect of treatment conditions and time , and intention-to-treat ( ITT ) analysis was applied to evaluate the effect of the independent variable . Results : The application of joint mobilization result ed in better scores of DFROM , CAIT , and SEBTs in the intervention group when compared with the placebo or the control groups ( p in CAIT [ mean = 5.23 , CI 95 % ( 4.63–5.84 ) ] , DFROM [ mean = 6.77 , CI 95 % ( 6.45–7.08 ) ] , anterior SEBT [ mean = 7.35 , CI 95 % ( 6.59–8.12 ) ] , posteromedial SEBT [ mean = 3.32 , CI 95 % ( 0.95–5.69 ) ] , and posterolateral SEBT [ mean = 2.55 , CI 95 % ( 2.20–2.89 ) ] . Conclusion : Joint mobilization techniques applied to subjects suffering from CAI were able to improve ankle DFROM , postural control , and self-reported instability . These results suggest that joint mobilization could be applied to patients with recurrent ankle sprain to help restore their functional stability . Implication s for Rehabilitation Functional instability is a very common sequela in patients with CAI , result ing in reduced quality of living due to the limitations it imposes on daily life activities . The mobilization with movement technique presented by Mulligan , and based on the joint mobilization accompanied by active movement , appears as a valuable tool to be employed by physical therapists to restore ankle function after a recurrent ankle sprain history . ROM restriction , subjective feeling of instability and dynamic postural control are benefiting from the joint mobilization application",
"PURPOSE The aim of the present study was to investigate the effects of a 6-wk multi-station proprioceptive exercise program that is easy to integrate in normal training programs . METHODS Patients with chronic ankle instability were used , and results of three testing procedures before and afterward were compared : joint position sense , postural sway , and muscle reaction times to sudden inversion events on a tilting platform . A total of 30 subjects with 48 unstable feet were evaluated ( exercise group : N = 31 ; control group : N = 17 ) . RESULTS In the exercise group , the results showed a significant improvement in joint position sense and postural sway as well as significant changes in muscle reaction times . CONCLUSION Based on the present results , a multi-station proprioceptive exercise program can be recommended for prevention and rehabilitation of recurrent ankle inversion injuries",
"The objective of the present study was to determine the effectiveness of a 6-week balance training program on patients with Chronic Ankle Instability ( CAI ) in relation to the results obtained in Dynamic Balance , subjective feeling of instability and pain using a single-blind r and omized controlled trial . 70 athletes were r and omly assigned to control or intervention group . The control group performed their usual training , and the intervention group was administered the same usual activity in addition to a balance program . The paired t-test was performed to evaluate the change scores in each group . The t-test for independent sample s was performed to evaluate between-group differences in change scores . Significance level was assigned for p-values less than 0.05 for all analyses . There were significant differences between groups in change scores in CAIT and all of the SEBTs reach distances ( p Pain ( p=0.586 ) . The effect sizes were larger for the outcomes measures that showed significant differences . In the within-group change , the experimental groups showed larger effect sizes in CAIT , SEBT posteromedial and SEBT posterolateral , and moderate effect sizes in SEBT anterior . Exercise therapy training based on multi-station balance tasks led to significant improvements in dynamic balance and self-reported sensation of instability in patients with CAI",
"PURPOSE The purpose of this r and omized controlled trial was to determine the effect of a 4-wk balance training program on static and dynamic postural control and self-reported functional outcomes in those with chronic ankle instability ( CAI ) . METHODS Thirty-one young adults with self-reported CAI were r and omly assigned to an intervention group ( six males and 10 females ) or a control group ( six males and nine females ) . The intervention consisted of a 4-wk supervised balance training program that emphasized dynamic stabilization in single-limb stance . Main outcome measures included the following : self-reported disability on the Foot and Ankle Disability Index ( FADI ) and the FADI Sport scales ; summary center of pressure ( COP ) excursion measures including area of a 95 % confidence ellipse , velocity , range , and SD ; time-to-boundary ( TTB ) measures of postural control in single-limb stance including the absolute minimum TTB , mean of TTB minima , and SD of TTB minima in the anteroposterior and mediolateral directions with eyes open and closed ; and reach distance in the anterior , posteromedial , and posterolateral directions of the Star Excursion Balance Test ( SEBT ) . RESULTS The balance training group had significant improvements in the FADI and the FADI Sport scores , in the magnitude and the variability of TTB measures with eyes closed , and in reach distances with the posteromedial and the posterolateral directions of the SEBT . Only one of the summary COP-based measures significantly changed after balance training . CONCLUSIONS Four weeks of balance training significantly improved self-reported function , static postural control as detected by TTB measures , and dynamic postural control as assessed with the SEBT . TTB measures were more sensitive at detecting improvements in static postural control compared with summary COP-based measures",
"STUDY DESIGN R and omized clinical trial . OBJECTIVES To determine whether manipulation of the proximal or distal tibiofibular joint would change ankle dorsiflexion range of motion and functional outcomes over a 3-week period in individuals with chronic ankle instability . BACKGROUND Altered joint arthrokinematics may play a role in chronic ankle instability dysfunction . Joint mobilization or manipulation may offer the ability to restore normal joint arthrokinematics and improve function . METHODS Forty-three participants ( mean ± SD age , 25.6 ± 7.6 years ; height , 174.3 ± 10.2 cm ; mass , 74.6 ± 16.7 kg ) with chronic ankle instability were r and omized to proximal tibiofibular joint manipulation , distal tibiofibular joint manipulation , or a control group . Outcome measures included ankle dorsiflexion range of motion , the single-limb stance on foam component of the Balance Error Scoring System , the step-down test , and the Foot and Ankle Ability Measure sports subscale . Measurements were obtained prior to the intervention ( before day 1 ) and following the intervention ( on days 1 , 7 , 14 , and 21 ) . RESULTS There was no significant change in dorsiflexion between groups across time . When groups were pooled , there was a significant increase ( P ) in dorsiflexion at each postintervention time interval . No differences were found among the Balance Error Scoring System foam , step-down test , and Foot and Ankle Ability Measure sports subscale scores . CONCLUSIONS The use of a proximal or distal tibiofibular joint manipulation in isolation did not enhance outcome effects beyond those of the control group . Collectively , all groups demonstrated increases in ankle dorsiflexion range of motion over the 3-week intervention period . These increases might have been due to practice effects associated with repeated testing . LEVEL OF EVIDENCE Therapy , level 2b-",
"BACKGROUND Ankle sprain has been studied in athletic cohorts , but little is known of its epidemiology in the general population . A longitudinal , prospect i ve epidemiological data base was used to determine the incidence and demographic risk factors for ankle sprains presenting to emergency departments in the United States . It was our hypothesis that ankle sprain is influenced by sex , race , age , and involvement in athletics . METHODS The National Electronic Injury Surveillance System ( NEISS ) was queried for all ankle sprain injuries presenting to emergency departments between 2002 and 2006 . Incidence rate ratios were then calculated with respect to age , sex , and race . RESULTS During the study period , an estimated 3,140,132 ankle sprains occurred among an at-risk population of 1,461,379,599 person-years for an incidence rate of 2.15 per 1000 person-years in the United States . The peak incidence of ankle sprain occurred between fifteen and nineteen years of age ( 7.2 per 1000 person-years ) . Males , compared with females , did not demonstrate an overall increased incidence rate ratio for ankle sprain ( incidence rate ratio , 1.04 ; 95 % confidence interval , 1.00 to 1.09 ) . However , males between fifteen and twenty-four years old had a substantially higher incidence of ankle sprain than their female counterparts ( incidence rate ratio , 1.53 ; 95 % confidence interval , 1.41 to 1.66 ) , whereas females over thirty years old had a higher incidence compared with their male counterparts ( incidence rate ratio , 2.03 ; 95 % confidence interval , 1.65 to 2.65 ) . Compared with the Hispanic race , the black and white races were associated with substantially higher rates of ankle sprain ( incidence rate ratio , 3.55 [ 95 % confidence interval , 1.01 to 6.09 ] and 2.49 [ 95 % confidence interval , 1.01 to 3.97 ] , respectively ) . Nearly half of all ankle sprains ( 49.3 % ) occurred during athletic activity , with basketball ( 41.1 % ) , football ( 9.3 % ) , and soccer ( 7.9 % ) being associated with the highest percentage of ankle sprains during athletics . CONCLUSIONS An age of ten to nineteen years old is associated with higher rates of ankle sprain . Males between fifteen and twenty-four years old have higher rates of ankle sprain than their female counterparts , whereas females over thirty years old have higher rates than their male counterparts . Half of all ankle sprains occur during athletic activity",
"CONTEXT There is minimal patient-oriented evidence regarding the effectiveness of interventions targeted to reduce symptoms associated with chronic ankle instability ( CAI ) . In addition , clinicians aim ing to prioritize care by implementing only the most effective components of a rehabilitative program have very little evidence on comparative efficacy . OBJECTIVE To assess the comparative efficacy of 2 common ankle rehabilitation techniques ( wobble-board [ WB ] balance training and ankle strengthening using resistance tubing [ RT ] ) using patient-oriented outcomes . DESIGN R and omized controlled trial . SETTING Laboratory . PATIENTS 40 patients with CAI r and omized into 2 treatment groups : RT and WB . CAI inclusion criteria included a history of an ankle sprain , recurrent \" giving way , \" and a Cumberl and Ankle Instability Tool ( CAIT ) score ≤25 . INTERVENTIONS Participants completed 5 clinician-oriented tests ( foot-lift test , time-in-balance , Star Excursion Balance Test , figure-of-8 hop , and side-hop ) and 5 patient-oriented question naires ( CAIT , Foot and Ankle Ability Measure [ FAAM ] , Activities of Daily Living [ ADL ] and FAAM Sport scale , Short-Form 36 [ SF-36 ] , and Global Rating of Function [ GRF ] ) . After baseline testing , participants completed 12 sessions over 4 wk of graduated WB or RT exercise , then repeated baseline tests . MAIN OUTCOME MEASURES For each patient- and clinician-oriented test , separate 2 × 2 RMANOVAs analyzed differences between groups over time ( alpha set at P = .05 ) . RESULTS There was a significant interaction between group and time for the FAAM-ADL ( P = .04 ) . Specifically , the WB group improved postintervention ( P the RT group remained the same ( P = .29 ) . There were no other significant interactions or significant differences between groups ( all P > .05 ) . There were significant improvements postintervention for the CAIT , FAAM-Sport , GRF , SF-36 , and all 5 clinician-oriented tests ( all P improve patient- and clinician-oriented outcomes in individuals with CAI . Limited evidence indicates that WB training was more effective than RT . LEVEL OF EVIDENCE Therapy , level 1b",
"Abstract Study Design : R and omized clinical trial . Objective : To determine the effect of strain counterstrain ( SCS ) on dynamic balance and subjective sense of instability in individuals with chronic ankle instability ( CAI ) . Although many studies have been published on CAI , the cause for this common clinical dysfunction remains inconclusive . No studies have assessed the effectiveness of SCS on CAI . Methods : At baseline all participants completed a demographic question naire , the star excursion balance test ( SEBT ) , and the foot and ankle ability measure ( FAAM ) . Following the baseline evaluation , participants were r and omized into the SCS experimental group ( EG ) ( n = 13 ) or the sham SCS group ( SG ) ( n = 14 ) . All participants received the assigned treatment once a week for 4 weeks and participated in a prescribed exercise program . At week 4 , all participants repeated the outcome measures and completed a global rating of change ( GROC ) form . The primary aim was examined with a two-way analysis of variance ( ANOVA ) . Results : A significant group-by-time interaction was found for seven directions in the SEBT ( P subjective measures , no significant group-by-time interaction was found for the FAAM ( P>0·548 ) , but the GROC revealed a significant difference ( P = 0·014 ) in the mean score for the EG ( 3·92±1·66 ) when compared to the SG ( 2·43±1·66 ) . Discussion : Although SCS may not have an effect on subjective ankle function in individuals with CAI , preliminary evidence suggests that SCS may lead to an improvement in dynamic ankle stability and the subjective sense of ankle instability . Level of Evidence : Therapy , Level 1b",
"CONTEXT Individuals with chronic ankle instability ( CAI ) have deficits in neuromuscular control and altered movement patterns . Ankle-destabilization devices have been shown to increase lower extremity muscle activity during functional tasks and may be useful tools for improving common deficits and self-reported function . OBJECTIVE To determine whether a 4-week rehabilitation program that includes destabilization devices has greater effects on self-reported function , range of motion ( ROM ) , strength , and balance than rehabilitation without devices in patients with CAI . DESIGN R and omized controlled clinical trial . SETTING Laboratory . PATIENTS OR OTHER PARTICIPANTS A total of 26 patients with CAI ( 7 men , 19 women ; age = 21.34 ± 3.06 years , height = 168.96 ± 8.77 cm , mass = 70.73 ± 13.86 kg ) . INTERVENTION(S ) Patients completed baseline measures and were r and omized into no-device and device groups . Both groups completed 4 weeks of supervised , impairment-based progressive rehabilitation with or without devices and then repeated baseline measures . MAIN OUTCOME MEASURE(S ) We assessed self-reported function using the Foot and Ankle Ability Measure . Ankle ROM was measured with an inclinometer . Ankle strength was assessed using a h and held dynamometer during maximal voluntary isometric contractions . Balance was measured using a composite score of 3 reach directions from the Star Excursion Balance Test and a force plate to calculate center of pressure during eyes-open and eyes-closed single-limb balance . We compared each dependent variable using a 2 × 2 ( group × time ) analysis of variance and post hoc tests as appropriate and set an a priori α level at .05 . The Hedges g effect sizes and associated 95 % confidence intervals were calculated . RESULTS We observed no differences between the no-device and device groups for any measure . However , both groups had large improvements in self-reported function and ankle strength . CONCLUSIONS Incorporating destabilization devices into rehabilitation did not improve ankle function more effectively than traditional rehabilitation tools because both interventions result ed in similar improvements . Impairment-based progressive rehabilitation improved clinical outcomes associated with CAI",
"STUDY DESIGN Controlled laboratory study . BACKGROUND Deficits in light touch have recently been identified on the plantar surface of the foot in those with chronic ankle instability ( CAI ) but not in uninjured controls . It is unknown whether copers display similar deficits . Similarly , cognitive loading has been shown to impact postural control in different population s , but it is unclear how it may impact sensory perception . OBJECTIVES To evaluate the difference in cutaneous sensation thresholds at rest and under cognitive loading , using Semmes-Weinstein monofilaments ( SWMs ) , among uninjured controls , copers , and those with CAI . METHODS A total of 45 participants ( mean ± SD age , 20.2 ± 2.8 years ; height , 167.6 ± 9.9 cm ; mass , 66.3 ± 14.7 kg ) were recruited and categorized to a CAI , coper , or control group , based on Ankle Instability Instrument scores . Participants were assessed with SWMs for cutaneous thresholds using a 4 - 2 - 1 stepping algorithm at the head of the first metatarsal , base of the fifth metatarsal , calcaneus , and sinus tarsi . Each participant was then retested while generating r and om digits to the beat of a metronome in order to simulate cognitive loading . RESULTS Participants with CAI displayed significantly higher SWM thresholds at the head of the first metatarsal , base of the fifth metatarsal , and sinus tarsi than those of the control participants , and significantly higher thresholds at the base of the fifth metatarsal and calcaneus than those of copers ( all , P showed higher thresholds than those of controls at the sinus tarsi only ( P effect of cognitive loading was identified at all 4 sites ( P People with CAI have deficits in plantar sensation relative to controls and copers . Cognitive loading increases plantar cutaneous sensation thresholds irrespective of CAI status",
"Functional instability is a common complication following an acute ankle sprain . Three potential contributing factors underlying the ankle which chronically gives way are proprioceptive deficits , muscle weakness , and ligamentous laxity . This study 's purpose was to document the presence or absence of these concerns in a sample of subjects with unilateral functional ankle instability . Both ankles of 42 subjects were r and omly assessed for passive movement sense into inversion and generation of peak torque by the evertors isokinetically . Thirty-four subjects were available for documentation of talar tilt of both ankles through inversion stress radiographs . Analysis found significantly greater mean values for passive movement sense and talar tilt for the involved ankles compared with the uninvolved , while no significant strength differences in peak torque of the evertors were present . Fifty-eight percent of the sample demonstrated clinical impairments in at least one of these three categories . In conclusion , deficits in passive movement sense and anatomic stability are greater concerns than strength deficits when managing the ankle with functional instability",
"INTRODUCTION Deficient sensory input from damaged ankle ligament receptors is thought to contribute to sensorimotor deficits in those with chronic ankle instability ( CAI ) . Targeting other viable sensory receptors may then enhance sensorimotor control in these patients . The purpose of this r and omized controlled trial was to evaluate the effects of 2 wk of sensory-targeted ankle rehabilitation strategies ( STARS ) on patient- and clinician-oriented outcomes in those with CAI . METHODS Eighty patients with self-reported CAI participated . All patients completed patient-oriented question naires capturing self-reported function as well as the weight-bearing lunge test and an eyes-closed single-limb balance test . After baseline testing , patients were r and omly allocated to four STARS groups : joint mobilization , plantar massage , triceps surae stretching , or control . Each patient in the intervention groups received six 5-min treatments of their respective STARS over 2 wk . All subjects were reassessed on patient- and clinician-oriented measures immediately after the intervention and completed a 1-month follow-up that consisted of patient-oriented measures . Change scores of the three STARS groups were compared with the control using independent t-tests and Hedges ' g effect sizes with 95 % confidence intervals . RESULTS The joint mobilization group had the greatest weight-bearing lunge test improvement . Plantar massage had the most meaningful single-limb balance improvement . All STARS groups improved patient-oriented outcomes with joint mobilization having the most meaningful effect immediately after the intervention and plantar massage at the 1-month follow-up . CONCLUSION Each STARS treatment offers unique contributions to the patient- and clinician-oriented rehabilitation outcomes of those with CAI . Both joint mobilization and plantar massage appear to demonstrate the greatest potential to improve sensorimotor function in those with CAI"
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Abstract Although several treatment options for panic disorder ( PD ) are available , the best intervention for each individual patient remains uncertain and the use of a more personalized therapeutic approach in PD is required . In clinical practice , clinicians combine general scientific information and personal experience in the decision-making process to choose a tailored treatment for each patient . In this sense , clinicians already use a somehow personalized medicine strategy . However , the influence of their interpretative personal models may lead to bias related to personal convictions , not sufficiently grounded on scientific evidence . Hence , an effort to give some advice based on the science of personalized medicine could have positive effects on clinicians ’ decisions . Based on a narrative review of meta-analyses , systematic review s , and experimental studies , we proposed a first-step attempt of evidence -based personalized therapy for PD . We focused on some phenomenological profiles , encompassing symptoms during/outside panic attacks , related patterns of physiological functions , and some aspects of physical health , which might be worth considering when developing treatment plans for patients with PD . We considered respiratory , cardiac , vestibular , and derealization/depersonalization profiles , with related implication s for treatment . Given the extensiveness of the topic , we considered only medications and some somatic interventions . Our proposal should be considered neither exhaustive nor conclusive , as it is meant as a very preliminary step toward a future , robust evidence -based personalized therapy for PD . Clearly much more work is needed to achieve this goal , and recent technological advances , such as wearable devices , big data platforms , and the application of machine learning techniques , may help obtain reliable findings . We believe that combining the efforts of different research groups in this work in progress can lead to largely shared conclusions in the near future
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"This study examined whether physical therapy with vestibular rehabilitation exercises would benefit patients with agoraphobia and vestibular dysfunction . Nine patients went through a 2-week no-treatment baseline phase , a 4-week behavioral treatment phase focusing on self-directed exposure , and an 8 - 12-week vestibular rehabilitation phase ( weekly sessions ) . On the main outcome measure , clinical global impressions ( CGI ) ratings of severity , behavioral treatment was accompanied by a reduction in severity ( effect size d=0.8 ; P Hamilton Anxiety Scale ( Hamilton-A ) and the Chambless Mobility Inventory ( MI ) , no significant improvements were noted . After vestibular rehabilitation therapy , further improvement occurred in CGI severity ( d=0.65 ; two-tailed P motion-induced dizziness and disturbances in balance in most patients . These improved with rehabilitation . Although the results can be attributed to other explanations , they are not inconsistent with the hypothesis that vestibular dysfunction maintains agoraphobic symptoms in some patients",
"OBJECTIVE There are numerous theories of panic disorder , each proposing a unique pathway of change leading to treatment success . However , little is known about whether improvements in proposed mediators are indeed associated with treatment outcomes and whether these mediators are specific to particular treatment modalities . Our purpose in this study was to analyze pathways of change in theoretically distinct interventions using longitudinal , moderated mediation analyses . METHOD Forty-one patients with panic disorder and agoraphobia were r and omly assigned to receive 4 weeks of training aim ed at altering either respiration ( capnometry-assisted respiratory training ) or panic-related cognitions ( cognitive training ) . Changes in respiration ( PCO₂ , respiration rate ) , symptom appraisal , and a modality-nonspecific mediator ( perceived control ) were considered as possible mediators . RESULTS The reductions in panic symptom severity and panic-related cognitions and the improvements in perceived control were significant and comparable in both treatment groups . Capnometry-assisted respiratory training , but not cognitive training , led to corrections from initially hypocapnic to normocapnic levels . Moderated mediation and temporal analyses suggested that in capnometry-assisted respiratory training , PCO₂ unidirectionally mediated and preceded changes in symptom appraisal and perceived control and was unidirectionally associated with changes in panic symptom severity . In cognitive training , reductions in symptom appraisal were bidirectionally associated with perceived control and panic symptom severity . In addition , perceived control was bidirectionally related to panic symptom severity in both treatment conditions . CONCLUSION The findings suggest that reductions in panic symptom severity can be achieved through different pathways , consistent with the underlying models",
"Agoraphobia in panic disorder ( PD ) has been related to abnormal balance system function . Vision influences balance and behavioural adaptations ; peripheral vision influences orienting and fast defensive reactions whereas central vision analyzes details of objects . We have hypothesized that the abnormal balance function in PD could be mainly related to peripheral vision as part of a defensive alarm system in the brain . In 25 patients with PD and agoraphobia and 31 healthy controls we assessed , by posturography , balance system reactivity to video-films projected in peripheral and central visual fields ( r and omized sequence ) . Length , velocity and surface of body sway were calculated . Patients increased their body sway during peripheral stimulation , whereas controls did not ; the two groups showed a similar increase of body sway during central stimulation . Anxiety levels during peripheral stimulation significantly influenced the postural response in the group of patients . These preliminary results suggest that the higher visual sensitivity to peripheral stimulation in patients with PD and agoraphobia may be linked to a more active \" visual alarm system \" involving visual , vestibular and limbic areas that might influence the development of agoraphobia in situations where environmental stimuli are uncertain",
"Experimental evidence suggests that panic disorder is characterized by abnormalities in the balance system function and that these abnormalities might be related to the severity of agoraphobic avoidance . Since the balance system can be modulated by the serotonergic system , we investigated the effect of a 6‐week treatment with citalopram on the balance system function in patients with panic disorder . Fifteen patients with panic disorder with/without agoraphobia underwent static posturography on days 0 and 42 . Static posturography and clinical assessment s were carried out by different investigators who were blind to each other . Static posturography showed high percentages of abnormal scores . Patients with no or low agoraphobic avoidance showed less abnormal posturographic measures than those with moderate to severe agoraphobia . After 6 weeks of treatment with citalopram there was a significant decrease of four out of six posturography measures in eyes‐closed and neck extension conditions , whereas no significant effect was found in the eyes‐open condition . This is the first report that suggests that the modulation of the serotonergic system can improve the balance system function in patients with panic disorder , particularly when visual information is lacking . In addition , our findings confirm the observation that many patients with panic disorder have abnormalities in their balance system function , supporting the idea that these abnormalities are mainly related to agoraphobic avoidance . Depression and Anxiety 17:101–106 , 2003 . © 2003 Wiley‐Liss ,",
"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",
"OBJECTIVES Alarming somatic symptoms and in particular the cardiovascular symptoms , are the characteristic features of panic attacks . Increased cardiac mortality and morbidity have been proposed in these patients . Power spectral analysis of electrocardiogram R-R intervals is known to be a particularly successful tool in the detection of autonomic instabilities in various clinical disorders . Heart rate variability ( HRV ) has been found to be the outcome of rapidly reacting cardiovascular control systems . The aim of our study is to measure very low frequency b and ( VLF ) , low frequency b and ( LF ) and high frequency b and ( HF ) components of R-R interval during orthostatic experiment in patients with panic disorder before and after treatment and compares it with healthy controls . METHODS We assessed heart rate variability in 19 patients with panic disorder before and after 6-weeks treatment with antidepressants combined with cognitive behavioral therapy ( CBT ) and in 18 healthy controls . Diagnosis was done according to the ICD-10 research diagnostic criteria confirmed with MINI ( MINI international neuropsychiatric interview ) . Patients were treated with CBT and psychotropics . They were regularly every week assessed using CGI ( Clinical Global Impression ) , BAI ( Beck Anxiety Inventory ) and BDI ( Beck Depression Inventory ) . Heart rate variability was assessed during 3 positions ( 1st - 5 min supine ; 2nd - 5 min st and ing ; 3rd - 5 min supine ) before and after the treatment . Power spectra were computed for very low frequency - VLF ( 0.0033 - 0.04 Hz ) , low-frequency - LF ( 0.04 - 0.15 Hz ) and high frequency - HF ( 0.15 - 0.40 Hz ) b and s using fast Fourier transformation . RESULTS Nineteen panic disorder patients resistant to pharmacological treatment entered a 6-week open-label treatment study with combination of SSRI and CBT . The combination of CBT and pharmacotherapy proved to be an effective treatment in these patients . The patients significantly improved during the study period in all rating scales . There were highly statistical significant differences between panic patients and control group in all components of power spectral analysis in 2nd ( VLF , LF and H in st and ing ) and in two component of 3rd ( LF and HF in supine ) positions . There was also a statistically significant difference between these two groups in LF/HF ratio in st and ing position ( 2nd ) . During therapy there was a tendency increasing values in all three positions in components of HRV power spectra , but HF in 1st supine position was the only component where the increase reached the level os statistical significance . CONCLUSIONS These findings demonstrate a lower autonomic activity in panic disorder patients measured during the changes of postural position in comparison with healthy controls and tendency to increase this autonomic power during the treatment",
"INTRODUCTION Serotonergic agents have greater effectiveness than noradrenergic ones in the treatment of Panic Disorder ( PD ) . However preliminary studies suggested that reboxetine might be effective in the treatment of PD . We compared the effectiveness and tolerability of reboxetine and paroxetine in the treatment of PD . METHODS Sixty-eight patients with PD were assigned to treatment groups in a single-blind , r and omized design . Each patient was assessed at day 0 and 90 by the Panic Associated Symptoms Scale ( PASS ) , the Sheehan Disability Scale ( SDS ) and the Fear Question naire ( FQ ) . Side effects were also recorded . RESULTS Reduction of PASS scores was significantly greater in the paroxetine group than in the reboxetine one . Vice versa we did not find any significant differences for other outcome measures . Sexual dysfunction and weight gain were significantly less frequent in the reboxetine group . CONCLUSIONS The results showed a greater effect of paroxetine on panic attacks than reboxetine , while no differences for anticipatory anxiety and avoidance were found , suggesting a different role of noradrenaline and serotonin in the treatment of PD",
"Abstract : The effects of short treatments ( 7 days ) with paroxetine and with reboxetine on the reactivity to inhalations of 35 % carbon dioxide (CO2)/65 % oxygen ( O2 ) were compared in 28 patients with Panic Disorder who had positive responses to 35 % CO2 inhalations . A double-blind , r and omized design was applied . Each patient was given the 35 % CO2 challenge on days 0 ( before starting the treatment ) and 7 . Anxiety reactivity to CO2 decreased significantly with both drugs but the decrease was significantly stronger in the group treated with paroxetine . The rate of patients whose reactivity has reduced of at least 50 % after 7 days was significantly higher in the group treated with paroxetine ( 10/14 , 71.5 % ) than in the one treated with reboxetine ( 3/14 , 21.5 % ) . These results indicate that the modulation of the serotonergic system is more relevant for CO2 hyperreactivity than the modulation of the noradrenergic one",
"Previous studies indicate that serotonin reuptake inhibitors do not appear to have serious cardiac side effects . However , the effects of these agents on respiratory measures have not been studied in detail . Several studies indicate that patients with anxiety exhibit irregular breathing patterns as measured by tidal volume and respiratory rate . In this study , we evaluated the effects of a serotonin reuptake inhibitor , paroxetine , on respiratory variability in patients with panic disorder ( n = 13 ) , using linear and nonlinear measures of regularity , approximate entropy ( APEN ) and a measure of chaos , the largest Lyapunov exponent ( LLE ) , with pre- and posttreatment lung volume time series ( 256 s long sample d at 4 Hz ) . Our results show that paroxetine significantly decreases some of the linear measures of variability and supine APEN and st and ing LLE of lung volume series after successful treatment . The implication s of these findings on respiratory and cardiovascular function have been discussed",
"BACKGROUND Anxiety disorders have gathered much attention as possible risk factors for the development of cardiovascular disease ( CVD ) , possibly mediated by an unhealthy lifestyle ( e.g. low physical activity ) . However , prospect i ve studies on anxiety disorders and CVD show conflicting results . A possible explanation is that somatic symptoms of anxiety may have a more specific cardiovascular effect than cognitive symptoms across different anxiety disorders . The present study investigated the association between cognitive and somatic symptoms of anxiety and physical activity ( PA ) in a sample of panic disorder ( PD ) out patients . METHODS One-hundred and two out patients with a lifetime diagnosis of PD from a previously studied cohort were contacted . Patients were evaluated throughout the MINI , the Beck Anxiety Inventory ( BAI ) and the International Physical Activity Question naire ( IPAQ ) . After performing a multivariate regression analysis , groups were divided into high and low somatic anxiety . RESULTS Patients with high somatic anxiety showed a significantly higher prevalence of low level of PA as compared to those with low somatic anxiety ( 62.5 versus 34.3 % ; χ²= 5.33 ; df=1 ; P=.021 ) . Somatic symptoms of anxiety remained the only important predictors of low level of PA ( odds ratio [ OR ] 2.81 ; 95 % CI 1.00 - 7.90 ; p=.050 ) in the multivariate model . LIMITATIONS The main limitations of the present study are the cross-sectional design and the small sample size . CONCLUSIONS Results support specific effects of somatic symptoms of anxiety on risk for low level of PA , which might explain inconsistent results regarding CVD risk in the literature",
"RATIONALE Psychologic factors are increasingly recognized to influence the onset and course of asthma . Previous cross-sectional community-based studies have provided evidence for a relatively specific association between asthma and panic . OBJECTIVES To examine concurrent and longitudinal associations between asthma and panic in young adults . MEASUREMENTS AND MAIN RESULTS Prospect i ve community-based cohort study of young adults ( n = 591 ) followed between ages 19 and 40 . Information was derived from six subsequent semistructured diagnostic interviews conducted by professionals . Cross-sectionally ( over the whole study period ) , asthma was more strongly associated with panic disorder ( odds ratio [ OR ] = 4.0 ; 95 % confidence interval [ CI ] , 1.7 , 9.3 ) than with any panic , which included panic disorder and panic attacks ( OR = 2.1 ; 95 % CI , 1.1 , 4.5 ) . Longitudinally , after adjusting for potentially confounding variables , active asthma predicted subsequent panic disorder ( OR = 4.5 ; 95 % CI , 1.1 , 20.1 ) , and the presence of panic disorder predicted subsequent asthma activity ( OR = 6.3 ; 95 % CI , 2.8 , 14.0 ) . Asthma predicted any panic ( OR = 2.7 ; 95 % CI , 1.1 , 7.1 ) , whereas any panic did not predict subsequent asthma activity . Associations were stronger in smokers than in nonsmokers , and stronger in women than in men . Smoking , early-childhood anxiety , and a family history of allergy were important confounders of the asthma-panic association . CONCLUSIONS This is the first long-term follow-up study on asthma and panic . It showed dose-response-type relationships between panic and asthma , and bidirectional longitudinal associations between the two conditions . It provided evidence for familial factors and smoking as possible shared etiologic explanations",
"The demographic , clinical and therapeutic features of the respiratory subtype of panic disorder ( PD ) versus the non-respiratory subtype were studied in a prospect i ve design . Sixty-seven PD out patients ( DSM-IV ) , who had previously been categorized into respiratory ( n=35 ) and non-respiratory ( n=32 ) subgroups , were openly treated with clonazepam for a 3-year period . The principal measure of efficacy was the number of panic attacks , obtained from the Sheehan Panic and Anticipatory Anxiety Scale . In the first 8 weeks of treatment ( acute phase ) , the respiratory subtype group had a significantly faster response to clonazepam . During the follow-up ( weeks 12 - 156 ) , the two subgroups did not differ significantly in the number of panic attacks experienced from baseline to end point . Patients in the respiratory subtype were characterized by a later onset of disorder and a family history of PD . Patients in the non-respiratory subgroup had a significantly higher number of past depressive episodes than those in the respiratory subgroup . The respiratory subgroup had a faster response after 8 weeks of treatment and an equivalent response in the 3-year follow-up period . Clonazepam had a sustained therapeutic effect over the entire treatment period",
"Abstract Paroxetine is widely prescribed because it has the indication for multiple psychiatric disorders . Our objective was to assess the effect of short-term administration of paroxetine on low-density lipoprotein cholesterol ( LDL-C ) levels in both healthy controls ( HCs ) and in patients with panic disorder ( PD ) . Blood sample s for measurement of LDL-C were collected atbaseline , after 8 weeks of paroxetine administration and post-discontinuation in 24 male HCs and nine male patients suffering from PD , for a total of 33 subjects . Paroxetine treatment , both in HCs and PD patients , induced a mean 9 % increase per subject in LDL-C that normalized post-discontinuation , suggesting causality . The National Cholesterol Education Program ( NCEP ) guidelines suggest that this paroxetine-induced increase in LDL-C is clinical ly significant but would not warrant therapeutic intervention in this population selected to be at low cardiovascular risk . However , the increase in LDL-C levels raised above the threshold of 2.7 mmol/L ( 100 mg/dL ) in 36 % of our low-risk subjects . The LDL-C increase in this subgroup would be associated with a minor increase in coronary heart disease ( CHD ) risk . A similar 9 % paroxetine-induced increase in LDL-C observed in the large number of psychiatric patients suffering from comorbid established CHD would be detrimental from a cardiovascular perspective and would oppose the new NCEP therapeutic goals of decreasing LDL-C levels by 30–40 % in high and moderately high-risk patients . It is possible that longer treatment duration and use of higher doses of paroxetine would lead to a greater increase in",
"BACKGROUND Chronic exercise has been shown to have therapeutic effects in panic disorder ( PD ) . The mechanism of these effects is unknown . Acute exercise reduces the effect of a panic challenge in healthy volunteers . Such an effect has not yet been demonstrated in PD patients . The present study aim ed at exploring the antipanic effects of acute exercise on a 35 % CO2 panic provocation in treatment-naïve PD patients to further eluci date the mechanisms of the beneficial effects of exercise on panic . METHODS Eighteen PD patients performed either moderate/hard exercise or very-light exercise before a 35 % CO2 challenge in a r and omized , between-group design . The reactivity to CO2 was assessed with the Visual Analogue Anxiety Scale and the DSM-IV Panic Symptom List . RESULTS Panic reactions to CO2 were smaller in patients that performed moderate/hard exercise in contrast to those that performed very-light exercise . Increments in both measurements and panic rates were consistently reduced by intense exercise . LIMITATIONS Since this study focuses on the acute effects of exercise on CO2 sensitivity in patients with PD , the results of repetitive exercise sessions on the rate of spontaneous panic attacks and overall symptoms are warranted . The small sample size and other limitations are addressed . CONCLUSIONS Exercise reduced the panicogenic effects of a CO2 challenge . In addition to its therapeutic potential , exercise may also be useful as a laboratory maneuver with heuristic value in experimental research into the mechanisms of antipanic treatment",
"BACKGROUND Disordered breathing among patients with panic disorder , including hyperventilation during attacks and increased anxiogenic response to carbon dioxide ( CO2 ) inhalation , is well established . We wished to assess whether there is a change in the physiological response to CO2 after patients have undergone antipanic therapy with either tricyclic antidepressants or cognitive behavioral therapy ( CBT ) . METHODS Twenty-nine patients with panic disorder underwent baseline CO2 sensitivity testing using the traditional Read rebreathing method and then received either antidepressant treatment ( n = 21 ) or CBT ( n = 8) . After completing treatment , CO2 testing was repeated . A comparison sample of 14 normal volunteers also had two CO2 sensitivity tests , separated by an average of 21.6 ( SD = 8.8 ) weeks . RESULTS Using a liberal st and ard , in which all CO2 sensitivity tests whose correlations between minute ventilation and end-tidal CO2 were at least .75 were used , patients , but not controls , demonstrated a significant reduction in CO2 sensitivity between the first and second test . Using a more conservative .90 correlation st and ard reduced the sample size available and result ed in trend reduction in patients but no significant change in controls . There was a suggestion that the change was most pronounced in treatment responders , although the number of patient nonresponders is extremely small in this sample . CONCLUSIONS These data indicate that treatment reduces CO2 sensitivity in patients with panic disorder . We speculate that manipulation of the serotonergic and noradrenergic neurotransmission systems , both known to play a role in the control of respiration , may have a specific effect in reducing respiratory hyperactivity in panic disorder",
"BACKGROUND Teaching anxious clients to stop hyperventilating is a popular therapeutic intervention for panic . However , evidence for the theory behind this approach is tenuous , and this theory is contradicted by an opposing theory of panic , the false-suffocation alarm theory , which can be interpreted to imply that the opposite would be helpful . OBJECTIVE To test these opposing approaches by investigating whether either , both , or neither of the 2 breathing therapies is effective in treating patients with panic disorder . METHOD We r and omly assigned 74 consecutive patients with DSM-IV-diagnosed panic disorder ( mean age at onset = 33.0 years ) to 1 of 3 groups in the setting of an academic research clinic . One group was trained to raise its end-tidal P(CO₂ ) ( partial pressure of carbon dioxide , mm Hg ) to counteract hyperventilation by using feedback from a h and -held capnometer , a second group was trained to lower its end-tidal P(CO₂ ) in the same way , and a third group received 1 of these treatments after a delay ( wait-list ) . We assessed patients physiologically and psychologically before treatment began and at 1 and 6 months after treatment . The study was conducted from September 2005 through November 2009 . RESULTS Using the Panic Disorder Severity Scale as a primary outcome measure , we found that both breathing training methods effectively reduced the severity of panic disorder 1 month after treatment and that treatment effects were maintained at 6-month follow-up ( effect sizes at 1-month follow-up were 1.34 for the raise-CO(2 ) group and 1.53 for the lower-CO(2 ) group ; P measurements of respiration at follow-up showed that patients had learned to alter their P(CO₂ ) levels and respiration rates as they had been taught in therapy . CONCLUSIONS Clinical improvement must have depended on elements common to both breathing therapies rather than on the effect of the therapies themselves on CO(2 ) levels . These elements may have been changed beliefs and expectancies , exposure to ominous bodily sensations , and attention to regular and slow breathing . TRIAL REGISTRATION Clinical Trials.gov identifier : NCT00183521",
"Panic disorder ( PD ) and asthma share many common characteristics and have been found in epidemiological studies to be significantly comorbid . To investigate possible reasons for this overlapping , the authors evaluated 51 patients with asthma , assessing the prevalence of PD and sporadic panic attacks , the temporal relationship between these two disorders , and the familial risk for PD in the families of asthmatics . The results showed significantly higher prevalences of PD , sporadic panic attacks , and social phobia in asthmatics than those reported for the general population . In 9 ( 90 % ) of the asthmatics with PD , asthma appeared first . Finally , the morbidity risk for PD in families of asthmatics with PD ( 13.5 % ) was significantly higher than in families of asthmatics without evidence of panic ( 2 % ) . Our results suggest that the high prevalence of PD in asthmatics might be related to a facilitating effect of asthma on the development of PD in subjects with familial predisposition to PD",
"Carbon dioxide ( CO2 ) inhalation induces acute anxiety and panic attacks in patients with Panic Disorder ( PD ) . Anti-panic drugs decrease CO2 reactivity after the first days of treatment ; however , the clinical meaning of this finding has not yet been established . This study investigated the effects of treatment with tricyclic antidepressants and selective serotonin re-uptake inhibitors ( SSRIs ) on CO2 reactivity and compared the relationships between 35 % CO2 hyperreactivity modulation and short-term clinical outcome . One hundred twenty-three patients with PD with or without agoraphobia who were hyperreactive to CO2 were r and omly assigned to treatment groups with imipramine , clomipramine , paroxetine , sertraline , or fluvoxamine . A double-blind , r and omized design was applied . Each patient received the 35 % CO2 challenge on days 0 , 7 , and 30 . The severity of clinical symptomatology was measured on days 0 and 30 . Decreased hyperreactivity to 35 % CO2 in all five treatment groups was already evident after the first week . The decrease in CO2 reactivity at the end of treatment was proportional to the degree of clinical improvement . Multiple regression analyses showed that the decrease in CO2 reactivity after the first week was a significant predictor for good clinical outcome after one month . The results of this study confirm evidence that psychoactive drugs effective in the treatment of PD decrease CO2 hyperreactivity . They also suggest that precocious modulation of CO2 reactivity might fairly reliably predict short-term clinical outcome in patients with “ respiratory ” PD",
"We investigated cardiac autonomic function in 16 patients with panic disorder before and after treatment with paroxetine using Holter ECG records . Our previous data suggest a relative increase in sympathetic activity in patients with panic disorder , especially during sleep . Data for 20 h and awake and sleep periods were analyzed using spectral analysis to quantify absolute and relative heart period variability in ultra low ( ULF : fractal dimensions ( FD ) for the 20-hour , awake and sleep time series of RR intervals . Paroxetine treatment ( 19.7 ± 4.7 mg/day for 105 ± 37 days ) result ed in a significant improvement in the frequency and intensity of panic attacks and also on the state anxiety inventory . Paroxetine treatment produced a significant decrease of 20-hour absolute HF power , awake absolute LF power and sleep absolute HF power . There was also a significant decrease of FDs after treatment with paroxetine for the sleep period . The decrease in LF and HF powers , and sleep FD is likely due to the antimuscarinic effect of paroxetine . The decrease in day-time LF power may also be due to a decrease in relative cardiac sympathetic activity after paroxetine treatment",
"A group of 20 patients who met the DSM-III-R criteria for panic disorder with or without agoraphobia underwent a 35 % carbon dioxide ( CO2 ) challenge after either 1 mg alprazolam or placebo in a double-blind , r and omized , cross-over design . Despite the anxiolytic potential of alprazolam , it produced no significant effects on CO2-induced anxiety and panic symptomatology when compared to placebo",
"BACKGROUND Given growing evidence that respiratory dysregulation is a central feature of panic disorder ( PD ) interventions for panic that specifically target respiratory functions could prove clinical ly useful and scientifically informative . We tested the effectiveness of a new , brief , capnometry-assisted breathing therapy ( BRT ) on clinical and respiratory measures in PD . METHODS Thirty-seven participants with PD with or without agoraphobia were r and omly assigned to BRT or to a delayed-treatment control group . Clinical status , respiration rate , and end-tidal pCO(2 ) were assessed at baseline , post-treatment , 2-month and 12-month follow-up . Respiratory measures were also assessed during homework exercises using a portable capnometer as a feedback device . RESULTS Significant improvements ( in PD severity , agoraphobic avoidance , anxiety sensitivity , disability , and respiratory measures ) were seen in treated , but not untreated patients , with moderate to large effect sizes . Improvements were maintained at follow-up . Treatment compliance was high for session attendance and homework exercises ; dropouts were few . CONCLUSIONS The data provide preliminary evidence that raising end-tidal pCO(2 ) by means of capnometry feedback is therapeutically beneficial for panic patients . Replication and extension will be needed to verify this new treatment 's efficacy and determine its mechanisms",
"During Phase II of the Cross-National Panic Study , descriptions of the patient 's last severe panic attack were collected for 1168 patients . Statistical analysis indicated that patients could be divided into two groups , characterised by the presence or absence of prominent respiratory symptoms . The two groups did not differ on demographic variables or coexisting diagnoses , but they did differ on psychopathology on entry to the study and treatment outcome . The group with prominent respiratory symptoms suffered more spontaneous panic attacks and responded to imipramine , whereas the group without prominent respiratory symptoms suffered more situational panic attacks and responded more to alprazolam . It is important to distinguish spontaneous and situational panic attacks , to aid choice of treatment",
"BACKGROUND Serotonin Selective Re-uptake Inhibitors ( SSRIs ) are the drugs of choice for treating panic disorder ( PD ) . In vitro studies have shown different pharmacodynamic profiles for SSRIs , but their clinical relevance is still unknown . Paroxetine , the SSRI with the strongest serotonergic effect , also shows significant cholinergic and noradrenergic activities . In this class of drugs , citalopram is the most selective for serotonin . We compared these two drugs and their effectiveness and tolerability in a sample of patients with PD in a two-month treatment course . METHOD Fifty-eight patients with PD were r and omly assigned to either the paroxetine or the citalopram treatment group in a single-blind , r and omized design . Each patient was assessed at days 0 , 7 and 60 by the Panic Associated Symptoms Scale ( PASS ) , the Sheehan Disability Scale ( SDS ) and the Fear Question naire ( FQ ) . Primary outcome measures were the percentage of patients free of panic attacks , anticipatory anxiety and phobic avoidance in the last week of the trial and the percentage of good responders , as defined by a reduction of at least 50 % from baseline of both PASS and SDS global scores at day 60 . RESULTS At day 60 , 86 % of patients receiving citalopram and 84 % of those receiving paroxetine responded well to treatment . No significant differences between the two drugs were found . Both were well tolerated , although sexual side effects and weight gain were frequent . Anticipatory anxiety decreased significantly after the first week of treatment , and no initial worsening in the panic attacks was observed . CONCLUSION Paroxetine and citalopram show similar anti-panic properties and a good tolerability profile . Our results support evidence that the serotonergic system plays a significant role in the anti-panic properties of these two SSRIs",
"We examined whether responses to the carbon dioxide ( CO(2 ) ) challenge test were correlated with clinical response . Thirty-four panic disorder patients participated in a CO(2 ) test after 1 h , 2 weeks and 6 weeks of treatment with clonazepam ( 2 mg/day ) or placebo . The clonazepam group had significantly fewer panic attacks in response to the CO(2 ) test and the test may predict clinical response",
"BACKGROUND Heart Rate Variability ( HRV ) parameters have been used to evaluate the autonomic nervous system . We hypothesized that patients with major depressive disorder ( MDD ) and panic disorder ( PD ) showed different HRV profiles compared to healthy controls . We also hypothesized that we could predict the responder groups in the MDD and PD patients , using differences in HRV indices between the stress and rest phases . METHODS 28 MDD patients and 29 PD patients were followed for 12 weeks , and we also followed 39 healthy control subjects . We measured HRV parameters at the rest , stress , and recovery phases . RESULTS Patients with MDD and PD demonstrated lower pNN50 than controls during the stress ( F = 7.49 , p = 0.001 ) , and recovery phases ( F = 9.43 , p = 0.0001 ) . Patients with MDD and PD also showed higher LF/HF ratio than controls during the stress phase ( F = 6.15 , p = 0.002 ) . Responders in the PD group presented a lower level of LF/HF ratio during the stress phase compared to non-responders ( F = 10.14 , p = 0.002 ) , while responders in the MDD group showed a lower level of heart rate during all three phases , compared to non-responders . Additionally , we could predict treatment response in patients with MDD using ΔLF/HF ratio ( OR : 1.33 , 95 % CI = 1.07 - 1.65 , p = 0.011 ) and ΔpNN50 ( OR : 1.49 , 95 % CI 1.09 - 1.77 , p = 0.014 ) . CONCLUSION The changes of HRV parameters of pNN50 and LF/HF ratio between the stress and recovery phase may be clinical markers of predictors of treatment responsiveness in MDD and PD patients",
"Abstract High-intensity interval training ( HIIT ) may produce strong physiological but also psychological effects within a short period . However , it is question able if this type of training is applicable and effective in patients with panic disorder ( PD ) because they are more vulnerable to the adverse effects of exercise . Twelve PD patients performed a 12-day HIIT trial . Every second day , patients performed 10 high-intensive 1-minute intervals at 77 % to 95 % of their maximum heart rate separated by 1-minute intervals with moderate to low intensity . All patients completed the 12-day training period . PD severity , agoraphobia , depression , general disorder severity , and endurance performance improved substantially with moderate to large effects sizes . Moreover , the increase in endurance performance was correlated with the reduction of depression and agoraphobia . HIIT was well tolerated by patients with PD and may induce rapid and strong therapeutic effects . A r and omized controlled clinical trial is needed to verify our findings"
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OBJECTIVES In-vitro experiments on ormocers ( ORganically MOdified CERamics ) have provided controversial results . Consequently , the objectives of this meta- analysis were to ( 1 ) compare clinical performances of first generation ormocers versus conventional composite restorations , ( 2 ) explore the influence of various clinical factors and the impact of the quality of studies on published results . METHODS The following data bases were explored until 2017/01/08 : Ovid MEDLINE In-Process , Pubmed , CENTRAL , HTA , DARE , LILACS and Google Scholar . Studies of more than two years with quantitative comparisons between ormocers and control groups were selected . Outcome was the failure of a restoration ( need to repair , remove or replace ) . Multivariate r and om-effects Poisson 's regression was used to obtain a summary estimate . RESULTS 75 % of the 8 included trials concerned Class I/II restorations . Although non-significant , the global failures were higher for ormocers ( 0.22 [ -0.16 ; 0.61 ] ) . For Class I/II restorations , a significantly higher sensitivity was observed for ormocer-based material s compared to other composites ( 0.75 [ 0.01 ; 1.50 ] ) . An increase of the number of restorations per patient was associated with higher marginal adaptation failures for ormocers in Class I/II obturations ( 0.59 [ 0.11 ; 1.08 ] ) . SIGNIFICANCE This study did not identify clear advantages of using the first generation of ormocer-based fillings rather than conventional composites . Given the recent development of new , dimethacrylate-diluent-free ormocer matrices , potentially more stable and resistant , new r and omized clinical trials should be developed comparing this new family of pure ormocers with current composites
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"Aims and Objectives : To compare the marginal sealing ability of ormocer with a hybrid composite using an ormocer based bonding agent and a conventional fifth generation bonding agent . Material s and Methods : Fifty four human premolars were r and omly distributed into four test groups of 12 teeth each and two control groups of 3 teeth each . Class I occlusal preparation of 1.5 mm depth were made in each tooth . These were restored using the adhesive and restorative material according to the group . The restorations were finished using a st and ard composite finishing and polishing kit . Thermocycling between 5 ° C and 55 ° C was carried out . Having blocked the root apex and the entire tooth surface except 1 mm around the restoration margin , the teeth were immersed in 2 % methylene blue for 48 hours , after which the dye penetration through the margins of each sample was studied under a stereomicroscope . Results and Discussion : Group IV ( Admira with Admira Bond ) showed the minimum marginal leakage with a mean of 0.200 mm . Four sample s in this group showed no microleakage at all and a maximum of 0.400 mm was seen in one sample . Group II ( Spectrum TPH with Admira Bond ) showed the maximum leakage with a mean of 0.433 mm . One sample showed as much as 1.00 mm of microleakage . Admira when used with Admira Bond showed lesser microleakage than Spectrum TPH used with Prime & Bond NT , the difference being statistically insignificant",
"Objective The aim of this study is to evaluate the color stability of two nanohybrid resin-based composites , two organic modified ceramic resin composites ( ormocers ) and a compomer , following their immersion during 4 weeks in four usual drinks . Material and methods Forty discs of each of the following material s were prepared : Gr and ioSO ( GR ) , Esthet X ( EX ) , Dyract EXTRA ( DY ) , Ceram X duo ( CX ) , and Admira Fusion ( AD ) . The discs were polished and stored in distilled water during 24 h at 37 ° C . Color according to the CIEL*a*b * scale was recoded . Ten r and omly selected sample s of each material were immersed in red wine ( RW ) , coffee ( CF ) , cola ( CK ) , and distilled water ( DW ) . The color was recorded after 1 , 7 , 21 and 28 days of immersion . The ΔE values between the baseline color and each of the study timepoints were calculated . The data were analyzed based on the Kruskal-Wallis test , Wilcoxon test , and Mann-Whitney U test . Results After 1 day of immersion , all the material s showed ΔE > 3.3 , except EX , CF , and CX in CK . RD was the most staining beverage ( ΔE 15.36 to 31.09 ) . EX and CX were significantly less stained than the rest of the material s ( p produced darkening beyond clinical ly acceptable limits . EX and CX were the material s who experimented less staining , followed by GD . AD and DY were the material s more stained . RW was the drink that produced more staining , followed by CF and CK . Clinical relevance After 24 h of immersion in all the solutions , equivalent to 1 month of exposure in the mouth , the evaluated material s showed clinical ly unacceptable ΔE values",
"PURPOSE This prospect i ve long-term clinical trial evaluated and compared the three-year clinical performance of an ormocer , a nanofilled , and a nanoceramic resin composite with that of a microhybrid composite placed in Class I and Class II cavities . METHODS Forty patients , each with four Class I and II restorations under occlusion , were enrolled in this study . A total of 160 restorations were placed , 25 % for each material , as follows : an ormocer-based composite , Admira ; a nanofilled resin composite , Filtek Supreme XT ; a nanoceramic resin composite , Ceram X ; and a microhybrid resin composite , Tetric Ceram . A single operator placed all restorations according to the manufacturers ' instructions . Immediately after placement the restorations were finished/polished . Clinical evaluation was performed at baseline and at yearly intervals after placement by two other independent examiners using modified US Public Health Service ( USPHS ) criteria . The changes in the USPHS parameters during the three-year period were analyzed with the Friedman test . Comparison of the baseline scores with those at the recall visits was made using the Wilcoxon signed rank test . The level of significance was set at p minor changes , and no differences were detected between their performance at baseline and after three years . Only two ormocer , one nanofilled , and one microhybrid restorations in molars failed because of loss of retention . Regarding the clinical performance , there were no statistically significant differences among the material s used ( p>0.05 ) . CONCLUSIONS The ormocer , nanofilled , and nanoceramic composites provided acceptable clinical performance over a three-year period",
"Abstract . This study investigated the clinical performance of two packable composite resins in Class-II restorations . One hundred and four Class-II restorations were placed in 52 patients by five dentists ( four in dental practice s and one in a university clinic ) in a controlled prospect i ve multicentre clinical trial . Each patient received one Definite/Etch & Prime 3.0 ( D-EP ) and one Solitaire/Solid Bond ( S-SB ) restoration , which were examined clinical ly according to modified USPHS- criteria after 1 week ( baseline ) and after 1 year . Statistical analysis was performed using the Wilcoxon rank sum test and the error rates method . The significance level was set to 0.05 . At baseline both material s performed equally according to the evaluated criteria . After 1 year D-EP showed significantly worse marginal adaptation compared to S-SB . Both material s displayed significant deterioration for the criteria marginal adaptation , marginal discolouration , approximal contact , and fracture of restoration after 1 year compared to baseline . With a failure rate of 9.6 % after 1 year , D-EP did not fulfill ADA acceptance criteria for restorative material s. It is proposed that at least 1-year data of clinical testing should be available before a new material is broadly marketed",
"OBJECTIVES To study monomer elution from four resin-based composites ( RBCs ) cured with different light sources . METHODS Twenty-eight premolars were r and omly allocated to four groups . St and ardized cavities were prepared and restored with a nanohybrid ( Filtek Supreme XT or Tetric EvoCeram ) , an ormocer ( Admira ) or a microhybrid RBC ( Filtek Z250 ) which served as control . Buccal restorations were cured with a halogen and oral restorations with an LED light-curing unit . Elution of diurethane dimethacrylate ( UDMA ) , Bisphenol A diglycidylether methacrylate ( BisGMA ) , triethylene glycol dimethacrylate ( TEGDMA ) and 2-hydroxyethyl methacrylate ( HEMA ) was analyzed using high-performance liquid chromatography ( HPLC ) 1h to 28 days post-immersion in 75 % ethanol . Data were analyzed using multivariate and repeated measures analysis of variance ( α = 0.05 ) . RESULTS The greatest elution of UDMA and BisGMA occurred from Tetric EvoCeram and the least from Filtek Z250 ( p halogen light-curing units gave similar results for all RBCs ( p > 0.05 ) except Tetric EvoCeram which showed greater elution for the LED unit ( p 0.05 ) . SIGNIFICANCE The two nanohybrid RBCs eluted more cross-linking monomers than the ormocer and the control microhybrid RBC . Continuous elution over 28 days indicates that RBCs act as a chronic source of monomers in clinical conditions . Light source may affect monomer elution since differences were found for one out of four RBCs . Mathematical models for elution kinetics of UDMA and BisGMA indicated two elution mechanisms",
"ABSTRACT Context : Microleakage around dental restorative material s is a major problem in clinical dentistry . Inspite of many new restorative material s available in the market very few actually bond to the tooth surface . Aims : The aims of this study were : ( 1 ) To evaluate and compare the marginal leakage of newer restorative material s viz colored compomer , ormocer , giomer and RMGIC in class I restoration of deciduous molars . ( 2 ) To compare the microleakage scores between the groups of : Colored compomer and ormocer , giomer and RMGIC , ormocer with giomer and RMGIC , giomer with RMGIC . Material s and methods : A total of 40 primary molars were r and omly divided into four groups of 10 each . Class I cavities were prepared and the cavities were restored with colored compomer ( Group A ) , Ormocer ( Group B ) , Giomer ( Group C ) and RMGIC ( Group D ) . The teeth were thermocycled and subjected to 0.5 % basic fuchsin dye penetration followed by sectioning . The cut sections were evaluated under a stereomicroscope and the data was subjected to statistical analysis . Statistical analysis used : Mann-Whitney U test and Student t-test . Results : No significant difference was observed when colored compomer was compared to ormocer , giomer and RMGIC . Ormocer showed significantly lower microleakage when compared to giomer . However , no significant difference was observed when ormocer was compared to RMGIC . No significant difference between giomer and RMGIC was found . Conclusion : Ormocer has proven to be an excellent restorative material as it showed least microleakage followed by colored compomer , giomer and RMGIC in increasing order . How to cite this article : Yadav G , Rehani U , Rana V. A Comparative Evaluation of Marginal Leakage of Different Restorative Material s in Deciduous Molars : An in vitro Study . Int J Clin Pediatr Dent 2012;5(2):101 - 107",
"PURPOSE To evaluate the 3-year clinical durability of the flowable bulk-fill resin composite SDR in Class I and Class II restorations . MATERIAL S AND METHODS Thirty-eight pairs of Class I and 62 pairs of Class II restorations were placed in 44 male and 42 female patients ( mean age 52.4 years ) . Each patient received at least two extended Class I or Class II restorations that were as similar as possible . In all cavities , a one-step self-etching adhesive ( XenoV+ ) was applied . One of the cavities of each pair was r and omly assigned to receive the flowable bulk-fill resin composite SDR in increments up to 4 mm as needed to fill the cavity 2 mm short of the occlusal cavosurface . The occlusal part was completed with an ormocer-based nanohybrid resin composite ( Ceram X mono+ ) . In the other cavity , only the resin composite CeramX mono+ was placed in 2 mm increments . The restorations were evaluated using slightly modified USPHS criteria at baseline and then annually for 3 years . Caries risk and bruxing habits of the participants were estimated . RESULTS No post-operative sensitivity was reported . At the 3-year follow-up , 196 restorations - 74 Class I and 122 Class II - were evaluated . Seven restorations failed ( 3.6 % ) , 4 SDR-CeramX mono+ and 3 CeramX mono+ only restorations , all of which were Class II . The main reason for failure was tooth fracture , followed by resin composite fracture . The annual failure rate ( AFR ) for all restorations ( Class I and II ) was 1.2 % for the bulkfilled restorations and 1.0 % for the resin composite-only restorations ( p > 0.05 ) . For the Class II restorations , the AFR was 2.2 % and 1.6 % , respectively . CONCLUSION The 4-mm bulk-fill technique showed good clinical effectiveness during the 3-year follow-up",
"Objectives The aim of this study is to observe the durability of Class II nanohybrid resin composite restorations , placed with two different adhesive systems , in an 8-year follow-up . Methods Seventy-eight participants received at r and om at least two Class II restorations of the ormocer-based nanohybrid resin composite ( Ceram X ) bonded with either a one-step self-etch adhesive ( Xeno III ) or a control two-step etch- and -rinse adhesive ( Excite ) . The 165 restorations were evaluated using slightly modified United States Public Health Services ( USPHS ) criteria at baseline and then yearly during 8 years . Results One hundred and fifty-eight restorations were evaluated after 8 years . Three participants with five restorations ( three Xeno III , two Excite ) were registered as dropouts . Twenty-one failed restorations ( 13.3 % ) were observed during the follow-up . Twelve in the one-step self-etch adhesive group ( 13.5 % ) and nine in the two-step etch- and -rinse group ( 13.0 % ) . This result ed in nonsignificant different annual failure rates of 1.69 and 1.63 % , respectively . Fracture of restoration was the main reason for failure . Conclusion Good clinical performance was shown during the 8-year evaluation and no significant difference in overall clinical performance between the two adhesives . Fracture was the main reason for failure . Clinical relevance The one-step self-etch adhesive showed a good long-term clinical effectiveness in combination with the nanohybrid resin composite in Class II restorations",
"The purpose of this study was to evaluate the clinical performance of two \" packable \" posterior composites : Prodigy Condensable/Optibond Solo — Kerr ( PC-OS ) and Definite/Etch & Prime — Degussa ( D-EP ) . Thirty-six patients participated in this study . A total of 78 restorations ( 40 with D-EP and 38 with PC-OS ) were made . Each patient received at least two restorations ( one of each studied material ) . The material s were h and led according to the manufacturer 's instructions . The occlusal adjustments were made at the placement visit . The restorations were finished and polished after 1 week . They were evaluated at baseline , and after 1 year and 2 years by two independent evaluators using the USPHS criteria . Colored slides were made of all the restorations . After 2 years , 34 patients and 74 restorations ( 38 with D-EP and 36 with PC-OS ) were available for evaluation . A total of 50 % of PC-OS restorations received A criterion and 50 % received B criterion ( 2.8 % color , 11.1 % marginal staining , 27.8 % superficial staining , 2.8 % anatomic form and 5.6 % marginal adaptation ) . For D-EP , 60.5 % of restorations received A criterion and 39.5 % received B criterion ( 2.6 % color , 5.3 % marginal staining , 10.5 % superficial staining , 7.9 % anatomic form and 13.2 % marginal adaptation ) . The C criterion was observed only for marginal adaptation with D-EP ( 2 restorations—5.3 % ) . The obtained data were tabulated and statistically analyzed using the Fisher , Chi-square and McNemar tests . After 2 years , PC-OS showed a significant increase in superficial and marginal staining . For D-EP the marginal adaptation and superficial staining became significantly worse than baseline",
"PURPOSE An equivalence r and omized controlled trial within the subject was organized to evaluate the clinical long-term success of a new 2-step etch & rinse adhesive and a new nano-filled ormocer . METHODS 50 subjects , 21 males and 29 females aged between 21 and 65 , were r and omized to receive 150 restorations , 100 with the new restorative material , 50 with the composite as control , placed in non-carious cervical lesions with the same bonding system . The main outcome measure was the cause of failure at 8 years . R and omization was number table-generated , with allocation concealment by opaque sequentially numbered sealed and stapled envelopes . Subjects , examiner , and analyst were blinded to group assignment . Two interim analyses were performed . Data were analyzed by ANOVA and Cox test ( P 40 subjects and 120 teeth were included in the analysis of the primary outcome . There were eight failures in the experimental group and four failures in the control group . The cumulative loss rate was 7 % for both restorative material s , with the annual failure lower than 1 % , without any statistically significant difference . There were two key elements of failure : the presence of sclerotic dentin and the relationship between lesion and gingival margin",
"The aim of this study was to evaluate the staining susceptibility of a silorane ( Filtek Silorane ) , an ormocer ( Ceram X Duo ) , a methacrylate ( Tetric EvoCeram ) and a compomer ( Dyract ) exposed on the long term to various staining agents by using ΔE and ΔE00 colour-difference formulas . Thirty-six disc-shaped specimens were made of each of the four chemically different material s , r and omly divided in six groups ( n = 6 ) and immersed in five staining solutions ( red wine , juice , coke , tea and coffee ) or stored dry ( control ) in an incubator at 37 ° C for 99 days . Spectrophotometric measurements by means of a spectrophotometer ( Spectroshade H and y Dental , MHT ) were repeated over a white ( L * = 92.6 , a * = −1.2 , b * = 2.9 ) and black ( L * = 1.6 , a * = 1.2 , b * = −1.0 ) background made of plasticized paper , in order to determine the colour changes according to ΔE , ΔE00 and translucency formulas . Statistical analysis was performed by means of factorial Anova , Fisher ’s LSD test ( post hoc ) and a Spearman rank correlation between ΔE and ΔE00 . When analysed over a white background , mean ΔE00 values were highly significantly different and varied from 0.8 ( Ceram X Duo/air ) to 20.9 ( Ceram X Duo/red wine ) . When analysed over a black background , mean ΔE00 values were highly significantly different and varied from 1.0 ( Ceram X Duo and Tetric/air ) to 25.2 ( Ceram X Duo/red wine ) . Differences in translucency varied from 0.3 ( Ceram X Duo/air ) to 21.1 ( Ceram X Duo/juice ) . The correlation between ΔE and ΔE00 over a white background was 0.9928 , while over a black background , it was 0.9886",
"PURPOSE The aim of this prospect i ve study was to evaluate the clinical performance of the restorative material Ceram . X in combination with an experimental one-bottle etch- and -rinse adhesive ( K-0127 ) . MATERIAL S AND METHODS A single operator placed two Class I or II restorations in molars of 43 patients . One molar was restored with Ceram . X/K-0127 ( Dentsply DeTrey ) , the other one with Tetric Ceram/Syntac Classic ( Ivoclar Vivadent ) . At baseline , after one , two , and four years the restorations were evaluated by a second dentist using modified Ryge 's criteria . After four years , 27 patients were examined . RESULTS In one patient , both restorations ( Class II ) had to be removed for root canal treatment due to pulpitis . Another Class II Ceram . X restoration ( 3.8 % ; 4.3 % [ 1 of 23 ] of Class II restorations ) showed score C with regard to wear/anatomical form . Thus , the cumulative failure rate was 7.4 % in the Ceram . X group ( 8.3 % of Class II restorations [ 2 of 24 ] ) and 3.7 % in the Tetric Ceram group ( 4.2 % of Class II restorations [ 1 of 24 ] ) . Furthermore , three restorations ( 11.5 % ) in each group showed score B for anatomical form and marginal integrity . Slight marginal discoloration ( score B ) was found at five Ceram . X restorations ( 19.2 % ) and four Tetric Ceram restorations ( 15.4 % ) . Two restorations ( 7.7 % ) in each group showed slight changes in color stability ( score B ) . No sensitivity , recurrent caries , or changes in surface texture were recorded after four years . No statistically significant differences were found between the two restorative material s ( p > 0.05 ) . CONCLUSION After four years of clinical service , 92.6 % of Ceram . X/K-0127 and 96.3 % of Tetric Ceram/Syntac Classic restorations performed clinical ly well",
"OBJECTIVES Ormocer composites , consisting of a silicon-based polymer , have been developed recently as a tooth-colored restorative material . The purpose of this prospect i ve r and omized clinical trial was to evaluate the performance of two small-particle hybrid ormocer-based restorative systems ( AD , Admira/Admira Bond , VOCO ; DE , Definite/Etch & Prime 3.0 , Dentsply ) and one small-particle hybrid bis-GMA-based composite restorative system ( TC , Tetric-Ceram/Syntac , Ivoclar-Vivadent ) in class II cavities . METHODS From 128 occlusal-proximal restorations ( 44 AD , 43 DE and 41 TC ) placed in 32 adult patients , eventually 77 ( 22 AD , 29 DE and 26 TC ) remained available for evaluation after 5 years . Their clinical performance was scored according to the USPHS criteria and evaluation of bite-wing radiographs . RESULTS After 5 years , eight AD , six DE and seven TC restorations had failed ( p=0.10 , log-rank test ) . The main reason was fracture or marginal gap formation , while secondary caries accounted for four failures . In all restorations the quality of surface , margins and contact point decreased significantly compared to baseline . DE had a significant poorer color match ( p<0.01 ) . Statistical evaluation using the KW test showed that failures were concentrated on specific patients . CONCLUSIONS In a group of class II restorations , there was no significant difference in failures after 5 years between ormocer-based and bis-GMA-based restorative systems",
"As new adhesives , composite resins , and bonding techniques were introduced , orthodontists adopted some of these innovations and added them to their armamentarium . The purpose of this study was to compare the shear bond strength ( SBS ) of two adhesive material s ; one with an organically modified ceramic matrix , Admira ( Voco , Cuxhaven , Germany ) and another that contains the traditional Bis GMA matrix namely Transbond XT ( 3 M Unitek , Monrovia , Calif ) . The new material s have a lower wear rate and are more biocompatible than traditional composites . Forty molar teeth were r and omly divided into two groups : 20 teeth bonded with the Transbond adhesive system and the other 20 teeth with the Admira bonding system . Student 's t-test was used to compare the SBS of the two adhesives . Significance was predetermined at P mean SBS for Admira was 5.1 + /- 3.3 MPa and that for Transbond XT was 4.6 + /- 3.2 MPa . It was concluded that the new material , Ormocer , which is an organically modified ceramic restorative material can potentially have orthodontic applications if available in a more flowable paste . These new material s are more biocompatible and have lower wear rate including bonding orthodontic brackets to teeth",
"About 35 years ago , Ryge provided a practical approach to evaluation of clinical performance of restorative material s. This systematic approach was soon universally accepted . While that methodology has served us well , a large number of scientific method ologies and more detailed questions have arisen that require more rigor . Current restorative material s have vastly improved clinical performance and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short term clinical investigations . However , the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques . For instance , a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches . Insensitivity , combined with the continually evolving and non-st and ard investigator modifications of the categories , scales , and reporting methods , has created a body of literature that is extremely difficult to meaningfully interpret . In many cases , the insensitivity of the original Ryge methods is misinterpreted as good clinical performance . While there are many good features of the original system , it is now time to move to a more contemporary one . The current review approaches this challenge in two ways : ( 1 ) a proposal for a modern clinical testing protocol for controlled clinical trials , and ( 2 ) an in-depth discussion of relevant clinical evaluation parameters , providing 84 references that are primarily related to issues or problems for clinical research trials . Together , these two parts offer a st and ard for the clinical testing of restorative material s/ procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials . Part 1 of the review considers the recruitment of subjects , restorations per subject , clinical events , validity versus bias , legal and regulatory aspects , rationale s for clinical trial design s , guidelines for design , r and omization , number of subjects , characteristics of participants , clinical assessment , st and ards and calibration , categories for assessment , criteria for evaluation , and supplemental documentation . Part 2 of the review considers categories of assessment for esthetic evaluation , functional assessment , biological responses to restorative material s , and statistical analysis of results . The overall review represents a considerable effort to include a range of clinical research interests over the past years . As part of the recognition of the importance of these suggestions , the review is being published simultaneously in identical form in both the “ Journal of Adhesive Dentistry ” and the “ Clinical Oral Investigations . ” Additionally an extended abstract will be published in the “ International Dental Journal ” giving a link to the web full version . This should help to introduce these considerations more quickly to the scientific community",
"OBJECTIVES Ormocer composites , consisting of a silicon-based polymer , have been developed recently as a tooth-coloured restorative material . The purpose of this prospect i ve r and omised clinical trial was to evaluate the performance of two small-particle hybrid ormocer-based restorative systems ( AD , Admira/Admira Bond , VOCO ; DE , Definite/Etch & Prime 3.0 , Dentsply ) and one small-particle hybrid bis-GMA-based composite restorative system ( TC , Tetric-Ceram/Syntac , Ivoclar-Vivadent ) in occlusal stress-bearing restorations . METHODS One hundred and twenty-eight occlusal-proximal restorations ( 44 AD , 43 DE and 41 TC ) were placed according to the manufacturer 's instructions in thirty-two adult patients . Their clinical performance was scored according to the USPHS criteria and evaluation of bite-wing radiographs . RESULTS After 3 years , four AD , five DE and four TC restorations had failed due to fracture or marginal gap formation . Surface roughness improved significantly when compared to the baseline in AD and TC ( Friedman test , p discolouration ( p internal porosities . ANOVA showed that larger restorations ( > or = 3 surfaces ) showed significantly more degradation than smaller ones . CONCLUSIONS In a group of class II restorations , there was no significant difference in failures after 3 years between ormocer-based and bis-GMA-based restorative systems"
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411737a0-06ff-11f0-808a-c43d1ab1c353
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Background Diabetes self-management education ( DSME ) can be delivered in many forms . Group based DSME is widespread due to being a cheaper method and the added advantages of having patient meet and discuss with each other . assess effects of group-based DSME compared to routine treatment on clinical , lifestyle and psychosocial outcomes in type-2 diabetes patients . Methods A systematic review with meta- analysis . Computerised bibliographic data base were search ed up to January 2008 for r and omised controlled trials evaluating group-based DSME for adult type-2 diabetics versus routine treatment where the intervention had at least one session and = />6 months follow-up . At least two review ers independently extracted data and assessed study quality . Results In total 21 studies ( 26 publications , 2833 participants ) were included . Of all the participants 4 out of 10 were male , baseline age was 60 years , BMI 31.6 , HbA1c 8.23 % , diabetes duration 8 years and 82 % used medication . For the main clinical outcomes , HbA1c was significantly reduced at 6 months ( 0.44 % points ; P = 0.0006 , 13 studies , 1883 participants ) , 12 months ( 0.46 % points ; P = 0.001 , 11 studies , 1503 participants ) and 2 years ( 0.87 % points ; P fasting blood glucose levels were also significantly reduced at 12 months ( 1.26 mmol/l ; P main lifestyle outcomes , diabetes knowledge was improved significantly at 6 months ( SMD 0.83 ; P = 0.00001 , 6 studies , 768 participants ) , 12 months ( SMD 0.85 ; P participants ) and self-management skills also improved significantly at 6 months ( SMD 0.55 ; P = 0.01 , 4 studies , 534 participants ) . For the main psychosocial outcomes , there were significant improvement for empowerment/self-efficacy ( SMD 0.28 , P = 0.01 , 2 studies , 326 participants ) after 6 months . For quality of life no conclusion could be drawn due to high heterogeneity . For the secondary outcomes there were significant improvements in patient satisfaction and body weight at 12 months for the intervention group . There were no differences between the groups in mortality rate , body mass index , blood pressure and lipid profile . Conclusions Group-based DSME in people with type 2 diabetes results in improvements in clinical , lifestyle and psychosocial outcomes
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"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",
"Background : The prevalence of type 2 diabetes and diabetesrelated morbidity and mortality is higher among low-income Hispanics when compared to that of Whites . However , little is known about how to effectively promote self-management in this population . Purpose : The objectives were first to determine the feasibility of conducting a r and omized clinical trial of an innovative self-management intervention to improve metabolic control in low-income Spanish-speaking individuals with type 2 diabetes and second to obtain preliminary data of possible intervention effects . Methods : Participants for this pilot study were recruited from a community health center , an elder program , and a community-wide data base developed by the community health center , in collaboration with other agencies serving the community , by surveying households in the entire community . Participants were r and omly assigned to an intervention ( n = 15 ) or a control ( n = 10 ) condition . Assessment s were conducted at baseline and at 3 months and 6 months postr and omization . The intervention consisted of 10 group sessions that targeted diabetes knowledge , attitudes , and self-management skills through culturally specific and literacysensitive strategies . The intervention used a cognitivebehavioral theoretical framework . Results : Recruitment rates at the community health center , elder program , and community registry were 48 % , 69 % , and 8 % , respectively . Completion rates for baseline , 3-month , and 6-month assessment s were 100 % , 92 % , and 92 % , respectively . Each intervention participant attended an average of 7.8 out of 10 sessions , and as a group the participants showed high adherence to intervention activities ( 93 % turned in daily logs , and 80 % self-monitored glucose levels at least daily ) . There was an overall Group × Time interaction ( p = .02 ) indicating group differences in glycosylated hemoglobin over time . The estimated glycosylated hemoglobin decrease at 3 months for the intervention group was −0.8 % ( 95 % confidence intervals = −1.1 % , −0.5 % ) compared with the change in the control group ( p = .02 ) . At 6 months , the decrease in the intervention group remained significant , −0.85 % ( 95 % confidence intervals = −1.2 , −0.5 ) , and the decrease was still significantly different from that of the controls ( p = .005 ) . There was a trend toward increased physical activity in the intervention group as compared to that of the control group ( p = .11 ) and some evidence ( nonsignificant ) of an increase in blood glucose self-monitoring in the intervention participants but not the control participants . Adjusting for baseline depressive scores , we oberved a significant difference in depressive symptoms between intervention participants and control participants at the 3-month assessment ( p = .02 ) . Conclusions : Low-income Spanish-speaking Hispanics are receptive to participate in diabetes-related research . This study shows that the pilot-tested diabetes self-management program is promising and warrants the conduct of a r and omized clinical trial",
"PURPOSE The purpose of this r and omized controlled trial is to determine the effectiveness of an intervention led by promotoras ( community lay workers ) on the glycemic control , diabetes knowledge , and diabetes health beliefs of Mexican Americans with type 2 diabetes living in a major city on the Texas-Mexico border . METHODS One hundred fifty Mexican American participants were recruited at a Catholic faith-based clinic and r and omized into 2 groups . Personal characteristics , acculturation , baseline A1C level , diabetes knowledge , and diabetes health beliefs were measured . The intervention was culturally specific and consisted of participative group education , telephone contact , and follow-up using inspirational faith-based health behavior change postcards . The A1C levels , diabetes knowledge , and diabetes health beliefs were measured 3 and 6 months postbaseline , and the mean change between the groups was analyzed . RESULTS The 80 % female sample , with a mean age of 58 years , demonstrated low acculturation , income , education , health insurance coverage , and strong Catholicism . No significant changes were noted at the 3-month assessment , but the mean change of the A1C levels , F(1 , 148 ) = 10.28 , P diabetes knowledge scores , F(1 , 148 ) = 9.0 , P health belief scores decreased in both groups . CONCLUSIONS The intervention result ed in decreased A1C levels and increased diabetes knowledge , suggesting that using promotoras as part of an interdisciplinary team can result in positive outcomes for Mexican Americans who have type 2 diabetes . Clinical implication s and recommendations for future research are suggested",
"Uncontrolled diabetes is a major health problem in Thail and . The objective of this study was to determine the effects of a diabetes self-management program on glycemic control , coronary heart disease ( CHD ) risk , and quality of life in 147 diabetic patients ( aged 56.8 + /- 10.2 years ) . Type 2 diabetic patients who met the research criteria were r and omized into two groups for a period of 6 months : the experimental group received the diabetes self-management program and the control group received the usual nursing care . The findings indicated that the experimental group demonstrated a significant decrease in the hemoglobin A(1c ) level and CHD risk , with an increase in quality of life ( QOL ) compared to the control group . The diabetes self-management program was effective for improving metabolic control and the QOL for individuals with diabetes . Further studies should be replicated using larger groups over a longer time frame",
"Background Multiple-risk-factor interventions offer a promising means for addressing the complex interactions between lifestyle behaviors , psychosocial factors , and the social environment . This report examines the long-term effects of a multiple-risk-factor intervention . Methods Postmenopausal women ( N = 279 ) with type 2 diabetes participated in the Mediterranean Lifestyle Program ( MLP ) , a r and omized , comprehensive lifestyle intervention study . The intervention targeted healthful eating , physical activity , stress management , smoking cessation , and social support . Outcomes included lifestyle behaviors ( i.e. , dietary intake , physical activity , stress management , smoking cessation ) , psychosocial variables ( e.g. , social support , problem solving , self-efficacy , depression , quality of life ) , and cost analyses at baseline , and 6 , 12 , and 24 months . Results MLP participants showed significant 12- and 24-month improvements in all targeted lifestyle behaviors with one exception ( there were too few smokers to analyze tobacco use effects ) , and in psychosocial measures of use of supportive re sources , problem solving , self-efficacy , and quality of life . Conclusion The MLP was more effective than usual care over 24 months in producing improvements on behavioral and psychosocial outcomes . Directions for future research include replication with other population",
"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",
"Background Epidemiologic data have shown that the prevalence of Type 2 diabetes varies with ethnic origin . Type 2 diabetes is up to four times more common in British South Asians than in the indigenous white population . The aim of this study was to develop a culturally appropriate educational intervention programme for South Asians with Type 2 diabetes . We then investigated whether this intervention could produce an improvement , and finally whether any improvement was greater than background changes in knowledge in comparison groups . Methods A multi-site prospect i ve , r and omised controlled study was conducted in all day care centres and three general practice registers with high proportion patients from different ethnic minority groups in Glasgow , Scotl and . The intervention consisted of 18 educational sessions in 6 separate programmes . A modified question naire was used to measure the knowledge , attitudes , and practice of diabetes before and after intervention . Results Baseline assessment showed that Indian and Pakistani subjects had less knowledge about diabetes , regarded the disease less seriously , and had a lesser underst and ing of the relationship between control and complications than the white population . No differences in initial responses were found between those who completed the second assessment and those who did not . The intervention group showed significant improvements in scores for Knowledge ( + 12.5 % ) ; Attitudes toward seriousness ( + 13.5 % ) , complications ( + 8.1 % ) , Practice ( + 20.0 % ) . However there were also changes in the ethnic control group scores ; respectively + 5.0 % , + 16.3 % ( significant P patients with Type 2 diabetes from ethnic minority groups is feasible and can improve their knowledge and attitudes and practice . However there was no net benefit compared with the control group",
"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",
"OBJECTIVE Few multiple lifestyle behavior change programs have been design ed to reduce the risk of coronary heart disease in postmenopausal women with type 2 diabetes . This study tested the effectiveness of the Mediterranean Lifestyle Program ( MLP ) , a comprehensive lifestyle self-management program ( Mediterranean low-saturated fat diet , stress management training , exercise , group support , and smoking cessation ) , in reducing cardiovascular risk factors in postmenopausal women with type 2 diabetes . RESEARCH DESIGN AND METHODS Postmenopausal women with type 2 diabetes ( n = 279 ) were r and omized to either usual care ( control ) or treatment ( MLP ) conditions . MLP participants took part in an initial 3-day retreat , followed by 6 months of weekly meetings , to learn and practice program components . Biological end points were changes in HbA(1c ) , lipid profiles , BMI , blood pressure , plasma fatty acids , and flexibility . Impact on quality of life was assessed . RESULTS Multivariate ANCOVAs revealed significantly greater improvements in the MLP condition compared with the usual care group on HbA(1c ) , BMI , plasma fatty acids , and quality of life at the 6-month follow-up . Patterns favoring intervention were seen in lipids , blood pressure , and flexibility but did not reach statistical significance . CONCLUSIONS These results demonstrate that postmenopausal women with type 2 diabetes can make comprehensive lifestyle changes that may lead to clinical ly significant improvements in glycemic control , some coronary heart disease risk factors , and quality of life",
"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",
"Living with Type 2 diabetes requires that patients develop a range of competencies that allow them to take greater control over the treatment of their disease . This requires education that promotes health whilst respecting individuals ' self-perceived needs and voluntary choices . Whilst such a concept is not new in the field of diabetes , health professionals are still struggling with how to administer it successfully . This paper presents the findings of a research trial of a theoretically constructed educational intervention . It focuses on the patients ' perspectives of what they valued about the intervention which was found to be clinical ly effective over a short-term period only . Limitations to maintaining effects were associated with a number of factors . The study found that whilst patients can be educated toward greater autonomy , not all health professionals are ready to work in partnership with them . It highlighted the importance of clinical staff not only gaining a better underst and ing of diabetes management , but also of the theoretical principles underlying patient empowerment . This paper outlines these principles and shows how they were synthesized to produce a framework for informing practice . Patients ' views are utilized to provide guidelines for improving the outcomes of patient education",
"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",
"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",
"PURPOSE We tested the feasibility and preliminary efficacy of a lifestyle intervention for middle-aged and older patients with schizophrenia and type-2 diabetes mellitus , using a r and omized pre-test , post-test control group design . METHOD Individuals with a diagnosis of schizophrenia or schizoaffective disorder over the age of 40 were r and omly assigned to 24-week Diabetes Awareness and Rehabilitation Training ( DART ; n=32 ) groups or Usual Care plus Information ( UCI ; n=32 ) comparison groups . Participants were recruited from board- and -care facilities and day treatment programs . Fifty-seven patients completed baseline and 6-month assessment s consisting of an interview , measures of body mass index , blood pressure , fasting blood chemistry , and accelerometry . A mixed-model analysis of variance was used to analyze the data . RESULTS A significant group x time interaction was found for body weight , with patients in the DART group losing a mean of 5 lb and those in the UCI gaining a mean 6 lb . Significant group x time interactions were also found for triglycerides , diabetes knowledge , diabetes self-efficacy , and self-reported physical activity , but not for fasting plasma glucose or glycosylated hemoglobin . CONCLUSIONS Group-based lifestyle interventions are feasible and produce positive health changes in middle-aged and older patients with schizophrenia and diabetes mellitus",
"OBJECTIVE To evaluate the efficacy of a programme of group education for diabetics , which succeeded in reducing base glucaemia , body mass index and glycosylated haemoglobin , stimulating insulin-treated patients ' self-monitoring of glucaemia , improving their underst and ing of the disease , and bringing into group education 75 % of the target population . DESIGN A controlled clinical trial with paired sample s , lasting two years . SETTING \" Las Fuentes Norte \" Health Centre , Zaragoza . PATIENTS 243 type-2 diabetics , distributed at r and om , with 120 in the intervention group and 123 in the control group . All patients with no history of group education in the previous two years and with no restrictions on their attending talks and monitoring were included . No-one gave up in the first year ; 9 did in the second year . INTERVENTION Group health education workshop for two days in the first and second years . MEASUREMENTS AND MAIN RESULTS In the intervention group , at the end of the study , success in the survey increased by 4.2 ; base glucaemia dropped by 17.1 mg/dl , glycate haemoglobin went down by 0.5 , and self- analysis went up by 14.2 % , all with significant differences ( p body mass index went down by 0.3 without significant differences . Knowledge was lost between the first and second year , with worse metabolic control . In the control group there were no significant differences in any variable . CONCLUSIONS A stable programme of group education may be effective , especially because of the increase in knowledge of the disease , fostering excellent conditions for a change to a healthier life-style",
"Exogenous obesity increases morbidity and mortality risk and has been associated with nutritional habits , which in turn can be affected by health education . Health education aims to promote patient participation in achieving behavior change and healthy lifestyles . The objective of this study is to show the advantages of participatory education in the modification of body mass index ( BMI ) in obese type-2 diabetics . A quasi-experimental study was performed with r and om allocation of two patient groups . The educational intervention was organized through a reflection-action process . BMI was measured at baseline and then monthly for 9 months during the intervention . The groups were analyzed by age and sex . Statistical analysis used the Student t test , with the mean difference for related groups . The control group showed a mean BMI of 33.89 + 1.96 and a final BMI of 33.2 + /- 2.15 ( t:22.4 ; p:0.16 ) . The experimental group had an initial value of 33.63 + /- 2.12 and a final BMI of 31.54 + /- 1.71 ; statistical difference : ( t:11.55 ; p:0.003 ) . The participatory educational intervention thus helped improve the BMI in obese type-2 diabetics",
"OBJECTIVES We evaluated lifestyle interventions for diabetic persons who live in rural communities . METHODS We conducted a 12-month r and omized clinical trial ( n = 152 ) of \" intensive-lifestyle \" ( modeled after the NIH Diabetes Prevention Program ) and \" reimbursable-lifestyle \" ( intensive-lifestyle intervention delivered in the time allotted for Medicare reimbursement for diabetes education related to nutrition and physical activity ) interventions with usual care as a control . RESULTS Modest weight loss occurred by 6 months among intensive-lifestyle participants and was greater than the weight loss among usual-care participants ( 2.6 kg vs 0.4 kg , P lost 2 kg or more than usual-care participants ( 49 % vs 25 % , P weight change were observed between reimbursable-lifestyle and usual-care participants . Glycated hemoglobin was reduced among all groups ( P Improvement in both weight and glycemia was attainable by lifestyle interventions design ed for persons who had type 2 diabetes and lived in rural communities"
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Concerns are growing regarding the role of dietary sugars in the development of obesity and cardiometabolic diseases , including diabetes . High-fructose corn syrup ( HFCS ) and sucrose are the most important dietary sweeteners . Both HFCS and sucrose have overlapping metabolic actions with adverse effects attributed to their fructose moiety . Ecological studies have linked the rise in fructose availability with the increases in obesity and diabetes worldwide . This link has been largely underpinned by animal models and select human trials of fructose overfeeding at high levels of exposure . Although prospect i ve cohort studies have shown significant associations comparing the highest with the lowest levels of intake sugar-sweetened beverages , these associations are small , do not hold at moderate levels of intake and are subject to collinearity effects from related dietary and lifestyle factors . Most systematic review s and meta-analyses from controlled feeding trials have shown that fructose-containing sugars in isocaloric exchange for other carbohydrates do not show evidence of harm and , in the case of fructose , may even have advantages for glycaemic control , especially at small doses . Nevertheless , trials in which fructose-containing sugars supplement diets with excess energy have shown adverse effects , effects that appear more attributable to the excess energy than the sugar . There is no unequivocal evidence that fructose intake at moderate doses is directly related with adverse metabolic effects , although there is potentially cause for concern where fructose is provided at high doses or contributes excess energy to diets . Further investigation is warranted due to the significant knowledge gaps and weaknesses in existing research
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"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",
"BACKGROUND The consumption of beverages that contain sugar is associated with overweight , possibly because liquid sugars do not lead to a sense of satiety , so the consumption of other foods is not reduced . However , data are lacking to show that the replacement of sugar-containing beverages with noncaloric beverages diminishes weight gain . METHODS We conducted an 18-month trial involving 641 primarily normal-weight children from 4 years 10 months to 11 years 11 months of age . Participants were r and omly assigned to receive 250 ml ( 8 oz ) per day of a sugar-free , artificially sweetened beverage ( sugar-free group ) or a similar sugar-containing beverage that provided 104 kcal ( sugar group ) . Beverages were distributed through schools . At 18 months , 26 % of the children had stopped consuming the beverages ; the data from children who did not complete the study were imputed . RESULTS The z score for the body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) increased on average by 0.02 SD units in the sugar-free group and by 0.15 SD units in the sugar group ; the 95 % confidence interval ( CI ) of the difference was -0.21 to -0.05 . Weight increased by 6.35 kg in the sugar-free group as compared with 7.37 kg in the sugar group ( 95 % CI for the difference , -1.54 to -0.48 ) . The skinfold-thickness measurements , waist-to-height ratio , and fat mass also increased significantly less in the sugar-free group . Adverse events were minor . When we combined measurements at 18 months in 136 children who had discontinued the study with those in 477 children who completed the study , the BMI z score increased by 0.06 SD units in the sugar-free group and by 0.12 SD units in the sugar group ( P=0.06 ) . CONCLUSIONS Masked replacement of sugar-containing beverages with noncaloric beverages reduced weight gain and fat accumulation in normal-weight children . ( Funded by the Netherl and s Organization for Health Research and Development and others ; DRINK Clinical Trials.gov number , NCT00893529 . )",
"BACKGROUND Certain dietary components may play a role in the prevention of type 2 diabetes . OBJECTIVE We examined prospect ively the associations between whole- and refined-grain intake and the risk of type 2 diabetes in a large cohort of men . DESIGN Men from the Health Professionals Follow-up Study without a history of diabetes or cardiovascular disease in 1986 ( n = 42898 ) were followed for whole and refined grains , measured every 4 y by use of food-frequency question naires , were used to predict subsequent type 2 diabetes risk through multivariate analysis . RESULTS We ascertained 1197 cases of incident type 2 diabetes . After adjustment for age ; physical activity ; cigarette smoking ; alcohol consumption ; family history of diabetes ; and fruit , vegetable , and energy intakes , the relative risk of type 2 diabetes was 0.58 ( 95 % CI : 0.47 , 0.70 ; P for trend risk of type 2 diabetes . After further adjustment for magnesium intake , cereal fiber intake , and glycemic load , the association between whole grains and type 2 diabetes was attenuated and the trend no longer significant . CONCLUSIONS In men , a diet high in whole grains is associated with a reduced risk of type 2 diabetes in men that may be mediated by cereal fiber . Efforts should be made to replace refined-grain with whole-grain foods",
"OBJECTIVE To examine associations between type 2 diabetes and fiber , glycemic load ( GL ) , dietary glycemic index ( GI ) , and fiber-rich foods . RESEARCH DESIGN AND METHODS This was a prospect i ve study of 36,787 men and women aged 40 - 69 years without diabetes . For all self-reported cases of diabetes at 4-year follow-up , confirmation of diagnosis was sought from medical practitioners . Case subjects were those who reported diabetes at follow-up and for whom there was no evidence that they did not have type 2 diabetes . Data were analyzed with logistic regression , adjusting for country of birth , physical activity , family history of diabetes , alcohol and energy intake , education , 5-year weight change , sex , and age . RESULTS Follow-up was completed by 31,641 ( 86 % ) participants , and 365 cases were identified . The odds ratio ( OR ) for the highest quartile of white bread intake compared with the lowest was 1.37 ( 95 % CI 1.04 - 1.81 ; P for trend = 0.001 ) . Intakes of carbohydrate ( OR per 200 g/day 0.58 , 0.36 - 0.95 ) , sugars ( OR per 100 g/day 0.61 , 0.47 - 0.79 ) , and magnesium ( OR per 500 mg/day 0.62 , 0.43 - 0.90 ) were inversely associated with incidence of diabetes , whereas intake of starch ( OR per 100 g/day 1.47 , 1.06 - 2.05 ) and dietary GI ( OR per 10 units 1.32 , 1.05 - 1.66 ) were positively associated with diabetes . These relationships were attenuated after adjustment for BMI and waist-to-hip ratio . CONCLUSIONS Reducing dietary GI while maintaining a high carbohydrate intake may reduce the risk of type 2 diabetes . One way to achieve this would be to substitute white bread with low-GI breads",
"BACKGROUND Little is known about the effects of the amount and type of carbohydrates on risk of coronary heart disease ( CHD ) . OBJECTIVE The objective of this study was to prospect ively evaluate the relations of the amount and type of carbohydrates with risk of CHD . DESIGN A cohort of 75521 women aged 38 - 63 y with no previous diagnosis of diabetes mellitus , myocardial infa rct ion , angina , stroke , or other cardiovascular diseases in 1984 was followed for 10 y. Each participant 's dietary glycemic load was calculated as a function of glycemic index , carbohydrate content , and frequency of intake of individual foods reported on a vali date d food-frequency question naire at baseline . All dietary variables were up date d in 1986 and 1990 . RESULTS During 10 y of follow-up ( 729472 person-years ) , 761 cases of CHD ( 208 fatal and 553 nonfatal ) were documented . Dietary glycemic load was directly associated with risk of CHD after adjustment for age , smoking status , total energy intake , and other coronary disease risk factors . The relative risks from the lowest to highest quintiles of glycemic load were 1.00 , 1.01 , 1 . 25 , 1.51 , and 1.98 ( 95 % CI : 1.41 , 2.77 for the highest quintile ; P for trend of CHD risk . The association between dietary glycemic load and CHD risk was most evident among women with body weights above average ¿ ie , body mass index ( in kg/m(2 ) ) > /= 23 . CONCLUSION These epidemiologic data suggest that a high dietary glycemic load from refined carbohydrates increases the risk of CHD , independent of known coronary disease risk factors",
"BACKGROUND During the nutrition transition in Chile , dietary changes were marked by increased consumption of high-energy , nutrient-poor products , including sugar-sweetened beverages ( SSBs ) . Obesity is now the primary nutritional problem in posttransitional Chile . OBJECTIVE We conducted a r and omized controlled trial to examine the effects on body composition of delivering milk beverages to the homes of overweight and obese children to displace SSBs . DESIGN We r and omly assigned 98 children aged 8 - 10 y who regularly consumed SSBs to intervention and control groups . During a 16-wk intervention , children were instructed to drink 3 servings/d ( approximately 200 g per serving ) of the milk delivered to their homes and to not consume SSBs . Body composition was measured by dual-energy X-ray absorptiometry . Data were analyzed by multiple regression analysis according to the intention-to-treat principle . RESULTS For the intervention group , milk consumption increased by a mean ( + /- SEM ) of 452.5 + /- 37.7 g/d ( P consumption of SSBs decreased by -711.0 + /- 33.7 g/d ( P milk consumption did not change , and consumption of SSBs increased by 71.9 + /- 33.6 g/d ( P = 0.04 ) . Changes in percentage body fat , the primary endpoint , did not differ between groups . Nevertheless , the mean ( + /- SE ) accretion of lean body mass was greater ( P = 0.04 ) in the intervention ( 0.92 + /- 0.10 kg ) than in the control ( 0.62 + /- 0.11 kg ) group . The increase in height was also greater ( P = 0.01 ) in the intervention group ( 2.50 + /- 0.21 cm ) than in the control group ( 1.77 + /- 0.20 cm ) for boys but not for girls . CONCLUSION Replacing habitual consumption of SSBs with milk may have beneficial effects on lean body mass and growth in children , despite no changes in percentage body fat . This trial was registered at clinical trials.gov as NCT00149695",
"BACKGROUND Inflammation is considered a key mechanism leading to type 2 diabetes , but dietary exposures that lead to inflammation and diabetes are largely unknown . OBJECTIVE Our objective was to investigate the relation between a dietary pattern associated with biomarkers of inflammation and the incidence of type 2 diabetes . DESIGN We conducted a nested case-control study of 656 cases of type 2 diabetes and 694 controls among women in the Nurses ' Health Study and 2 prospect i ve cohort studies of 35,340 women in the Nurses ' Health Study and 89,311 women in the Nurses ' Health Study II who were followed for incident diabetes . RESULTS Through the use of reduced rank regression , we identified a dietary pattern that was strongly related to inflammatory markers in the nested case-control study . This pattern , which was high in sugar-sweetened soft drinks , refined grains , diet soft drinks , and processed meat but low in wine , coffee , cruciferous vegetables , and yellow vegetables , was associated with an increased risk of diabetes ( multivariate-adjusted odds ratio comparing extreme quintiles : 3.09 ; 95 % CI : 1.99 , 4.79 ) . We identified 1517 incident cases of confirmed type 2 diabetes in the Nurses ' Health Study ( 458,991 person-years ) and 724 incident cases in the Nurses ' Health Study II ( 701,155 person-years ) . After adjustment for body mass index and other potential lifestyle confounders , the relative risks comparing extreme quintiles of the pattern were 2.56 ( 95 % CI : 2.10 , 3.12 ; P for trend dietary pattern identified may increase chronic inflammation and raise the risk of developing type 2 diabetes",
"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",
"BACKGROUND Dietary carbohydrates may influence the development of type 2 ( non-insulin-dependent ) diabetes , for example , through effects on blood glucose and insulin concentrations . OBJECTIVE We examined the relations of baseline intake of carbohydrates , dietary fiber , dietary magnesium , and carbohydrate-rich foods and the glycemic index with incidence of diabetes . DESIGN This was a prospect i ve cohort study of 35988 older Iowa women initially free of diabetes . During 6 y of follow-up , 1141 incident cases of diabetes were reported . RESULTS Total grain , whole-grain , total dietary fiber , cereal fiber , and dietary magnesium intakes showed strong inverse associations with incidence of diabetes after adjustment for potential nondietary confounding variables . Multivariate-adjusted relative risks of diabetes were 1.0 , 0.99 , 0.98 , 0.92 , and 0.79 ( P for trend : 0.0089 ) across quintiles of whole-grain intake ; 1.0 , 1.09 , 1.00 , 0.94 , and 0.78 ( P for trend : 0.005 ) across quintiles of total dietary fiber intake ; and 1.0 , 0.81 , 0.82 , 0.81 , and 0.67 ( P for trend : 0.0003 ) across quintiles of dietary magnesium intake . Intakes of total carbohydrates , refined grains , fruit and vegetables , and soluble fiber and the glycemic index were unrelated to diabetes risk . CONCLUSION These data support a protective role for grains ( particularly whole grains ) , cereal fiber , and dietary magnesium in the development of diabetes in older women",
"BACKGROUND Potatoes , a high glycemic form of carbohydrate , are hypothesized to increase insulin resistance and risk of type 2 diabetes . OBJECTIVE The objective was to examine prospect ively the relation between potato consumption and the risk of type 2 diabetes . DESIGN We conducted a prospect i ve study of 84,555 women in the Nurses ' Health Study . At baseline , the women were aged 34 - 59 y , had no history of chronic disease , and completed a vali date d food-frequency question naire . The participants were followed for 20 y with repeated assessment of diet . RESULTS We documented 4496 new cases of type 2 diabetes . Potato and french fry consumption were both positively associated with risk of type 2 diabetes after adjustment for age and dietary and nondietary factors . The multivariate relative risk ( RR ) in a comparison between the highest and the lowest quintile of potato intake was 1.14 ( 95 % CI : 1.02 , 1.26 ; P for trend = 0.009 ) . The multivariate RR in a comparison between the highest and the lowest quintile of french fry intake was 1.21 ( 95 % CI : 1.09 , 1.33 ; P for trend RR of type 2 diabetes was 1.18 ( 95 % CI : 1.03 , 1.35 ) for 1 daily serving of potatoes and 1.16 ( 95 % CI : 1.05 , 1.29 ) for 2 weekly servings of french fries . The RR of type 2 diabetes for substituting 1 serving potatoes/d for 1 serving whole grains/d was 1.30 ( 95 % CI : 1.08 , 1.57 ) . The association between potato consumption and risk of type 2 diabetes was more pronounced in obese women . CONCLUSIONS Our findings suggest a modest positive association between the consumption of potatoes and the risk of type 2 diabetes in women . This association was more pronounced when potatoes were substituted for whole grains",
"To determine the relations of diet with risk of clinical noninsulin-dependent diabetes , we analyzed data from a prospect i ve cohort of 84360 US women . During 6 y of follow-up we identified 702 definite incident cases . Because body mass index ( BMI ) is a powerful risk factor for diabetes , we examined the relations of fat ( including type ) , fiber , sucrose , and other components of diet to risk of diabetes , among women with BMI s ( in kg/m2 ) less than 29 kg/m2 . After controlling for body mass index , previous weight change , and alcohol intake , we observed no associations between intakes of energy , protein , sucrose , carbohydrate , or fiber and risk of diabetes . Compared with women in the lowest quintile of energy-adjusted intake , and relative risks ( and tests for trend ) for those in the highest quintile were 0.61 ( P trend = 0.03 ) for vegetable fat , 0.62 ( P trend = 0.008 ) for potassium , 0.70 ( P trend = 0.005 ) for calcium , and 0.68 ( P trend = 0.02 ) for magnesium . These inverse associations were attenuated among obese women ( BMI s greater than or equal to 29 )",
"The study objective was to determine whether a small dose of fructose administered before or simultaneously with a high glycemic index , starchy food decreases postpr and ial glycemic response . Nondiabetic healthy adults ( n = 31 ; mean + /- SEM : age , 26 + /- 1 y ; weight , 66.1 + /- 2.6 kg ; body mass index , 23.3 + /- 0.6 kg/m(2 ) ) were studied in a r and omized crossover design . Treatments consisted of 50 g available carbohydrate from instant mashed potatoes fed alone ( control ) or with 10 g fructose fed 60 , 30 or 0 min before the potato meal . Capillary finger-stick blood sample s were analyzed for glucose concentration at -60 , -30 , 0 , 15 , 30 , 45 , 60 , 90 and 120 min relative to the ingestion of the potato meal . Compared with the control , the positive incremental area under the glucose curve was reduced 25 and 27 % ( P fructose lowers the glycemic response to a glucose solution , we found that fructose must be consumed before a starchy food to reduce postpr and ial glycemia",
"The determine the effect of different foods on the blood glucose , 62 commonly eaten foods and sugars were fed individually to groups of 5 to 10 healthy fasting volunteers . Blood glucose levels were measured over 2 h , and expressed as a percentage of the area under the glucose response curve when the same amount of carbohydrate was taken as glucose . The largest rises were seen with vegetables ( 70 + /- 5 % ) , followed by breakfast cereals ( 65 + /- 5 % ) , cereals and biscuits ( 60 + /- 3 % ) , fruit ( 50 + /- 5 % ) , dairy products ( 35 + /- 1 % ) , and dried legumes ( 31 + /- 3 % ) . A significant negative relationship was seen between fat ( p less than 0.01 ) and protein ( p less than 0.001 ) and postpr and ial glucose rise but not with fiber or sugar content",
"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",
"BACKGROUND The consumption of sucrose-sweetened soft drinks ( SSSDs ) has been associated with obesity , the metabolic syndrome , and cardiovascular disorders in observational and short-term intervention studies . Too few long-term intervention studies in humans have examined the effects of soft drinks . OBJECTIVE We compared the effects of SSSDs with those of isocaloric milk and a noncaloric soft drink on changes in total fat mass and ectopic fat deposition ( in liver and muscle tissue ) . DESIGN Overweight subjects ( n = 47 ) were r and omly assigned to 4 different test drinks ( 1 L/d for 6 mo ) : SSSD ( regular cola ) , isocaloric semiskim milk , aspartame-sweetened diet cola , and water . The amount of intrahepatic fat and intramyocellular fat was measured with (1)H-magnetic resonance spectroscopy . Other endpoints were fat mass , fat distribution ( dual-energy X-ray absorptiometry and magnetic resonance imaging ) , and metabolic risk factors . RESULTS The relative changes between baseline and the end of 6-mo intervention were significantly higher in the regular cola group than in the 3 other groups for liver fat ( 132 - 143 % , sex-adjusted mean ; P skeletal muscle fat ( 117 - 221 % ; P visceral fat ( 24 - 31 % ; P blood triglycerides ( 32 % ; P total cholesterol ( 11 % ; P Total fat mass was not significantly different between the 4 beverage groups . Milk and diet cola reduced systolic blood pressure by 10 - 15 % compared with regular cola ( P diet cola had effects similar to those of water . CONCLUSION Daily intake of SSSDs for 6 mo increases ectopic fat accumulation and lipids compared with milk , diet cola , and water . Thus , daily intake of SSSDs is likely to enhance the risk of cardiovascular and metabolic diseases . This trial is registered at clinical trials.gov as NCT00777647",
"Soft drinks and other sweetened beverages may contribute to risk of type 2 diabetes and obesity . However , research has not addressed higher risk and Asian population s. The authors examined the association between soft drinks and juice and the risk of type 2 diabetes among Chinese Singaporeans enrolled in a prospect i ve cohort study of 43,580 participants aged 45 - 74 years and free of diabetes and other chronic diseases at baseline . The incidence of physician-diagnosed type 2 diabetes was assessed by interview and vali date d ; 2,273 participants developed diabetes during follow-up . After adjustment for potential lifestyle and dietary confounders , participants consuming > or = 2 soft drinks per week had a relative risk of type 2 diabetes of 1.42 ( 95 % confidence interval ( CI ) : 1.25 , 1.62 ) compared with those who rarely consumed soft drinks . Similarly , consumption of > or = 2 juice beverages per week was associated with an increased risk ( relative risk ( RR ) = 1.29 , 95 % CI : 1.05 , 1.58 ) . The association was modified by 5-year weight gain for > or = 2 soft drinks per week among those who gained > or =3 kg ( RR = 1.70 , 95 % CI : 1.34 , 2.16 ) compared with those who gained less weight ( RR = 1.20 , 95 % CI : 1.03 , 1.41 ) . Relatively frequent intake of soft drinks and juice is associated with an increased risk for development of type 2 diabetes in Chinese men and women",
"CONTEXT Sugar-sweetened beverages like soft drinks and fruit punches contain large amounts of readily absorbable sugars and may contribute to weight gain and an increased risk of type 2 diabetes , but these relationships have been minimally addressed in adults . OBJECTIVE To examine the association between consumption of sugar-sweetened beverages and weight change and risk of type 2 diabetes in women . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve cohort analyses conducted from 1991 to 1999 among women in the Nurses ' Health Study II . The diabetes analysis included 91,249 women free of diabetes and other major chronic diseases at baseline in 1991 . The weight change analysis included 51,603 women for whom complete dietary information and body weight were ascertained in 1991 , 1995 , and 1999 . We identified 741 incident cases of confirmed type 2 diabetes during 716,300 person-years of follow-up . MAIN OUTCOME MEASURES Weight gain and incidence of type 2 diabetes . RESULTS Those with stable consumption patterns had no difference in weight gain , but weight gain over a 4-year period was highest among women who increased their sugar-sweetened soft drink consumption from 1 or fewer drinks per week to 1 or more drinks per day ( multivariate-adjusted means , 4.69 kg for 1991 to 1995 and 4.20 kg for 1995 to 1999 ) and was smallest among women who decreased their intake ( 1.34 and 0.15 kg for the 2 periods , respectively ) after adjusting for lifestyle and dietary confounders . Increased consumption of fruit punch was also associated with greater weight gain compared with decreased consumption . After adjustment for potential confounders , women consuming 1 or more sugar-sweetened soft drinks per day had a relative risk [ RR ] of type 2 diabetes of 1.83 ( 95 % confidence interval [ CI ] , 1.42 - 2.36 ; P fruit punch was associated with increased diabetes risk ( RR for > or = 1 drink per day compared with sugar-sweetened beverages is associated with a greater magnitude of weight gain and an increased risk for development of type 2 diabetes in women , possibly by providing excessive calories and large amounts of rapidly absorbable sugars",
"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",
"OBJECTIVE To investigate the long-term effects of changes in dietary carbohydrate/fat ratio and simple vs complex carbohydrates . DESIGN R and omized controlled multicentre trial ( CARMEN ) , in which subjects were allocated for 6 months either to a seasonal control group ( no intervention ) or to one of three experimental groups : a control diet group ( dietary intervention typical of the average national intake ) ; a low-fat high simple carbohydrate group ; or a low-fat high complex carbohydrate group . SUBJECTS Three hundred and ninety eight moderately obese adults . MEASUREMENTS The change in body weight was the primary outcome ; changes in body composition and blood lipids were secondary outcomes . RESULTS Body weight loss in the low-fat high simple carbohydrate and low-fat high complex carbohydrate groups was 0.9 kg ( P control diet and seasonal control groups gained weight ( 0.8 and 0.1 kg , NS ) . Fat mass changed by -1.3 kg ( P Changes in blood lipids did not differ significantly between the dietary treatment groups . CONCLUSION Our findings suggest that reduction of fat intake results in a modest but significant reduction in body weight and body fatness . The concomitant increase in either simple or complex carbohydrates did not indicate significant differences in weight change . No adverse effects on blood lipids were observed . These findings underline the importance of this dietary change and its potential impact on the public health implication s of obesity",
"OBJECTIVE To investigate prospect ively whether intake of total or type of sugar is associated with the risk of developing type 2 diabetes . The contribution of sugar intake to the pathogenesis of type 2 diabetes has not been settled in the context of primary prevention because of limited prospect i ve data . RESEARCH DESIGN AND METHODS The Women 's Health Study is a r and omized controlled trial of aspirin and vitamin E in the prevention of cardiovascular disease and cancer . A vali date d semiquantitative food frequency question naire was completed by 39,345 women aged 45 years and older . The main outcome was the incidence of type 2 diabetes . The predictor was sugar intake , including sucrose , glucose , fructose , and lactose . Using Cox proportional hazard models , multivariate RRs of type 2 diabetes for increasing quintiles of sugar intake compared with the lowest quintile were estimated . RESULTS Compared with the lowest quintile of sugar intake , the RRs and 95 % CIs for the highest quintiles were 0.84 ( 0.67 - 1.04 ) for sucrose , 0.96 ( 0.78 - 1.19 ) for fructose , 1.04 ( 0.85 - 1.28 ) for glucose , and 0.99 ( 0.80 - 1.22 ) for lactose , after adjustment for known risk factors for type 2 diabetes . Similar findings of no association were obtained in subgroup analyses stratified by BMI . CONCLUSIONS Intake of sugars does not appear to play a deleterious role in primary prevention of type 2 diabetes . These prospect i ve data support the recent American Diabetes Association 's guideline that a moderate amount of sugar can be incorporated in a healthy diet",
"BACKGROUND Consumption of sugar-sweetened beverages ( SSBs ) is associated with an increased risk of hypertension in cross-sectional studies . However , prospect i ve data are limited . OBJECTIVE To examine the associations between SSBs and artificially sweetened beverages ( ASBs ) with incident hypertension . DESIGN AND SETTING Prospect i ve analysis using Cox proportional hazards regression to examine the association between SSBs and ASBs with incident hypertension in three large , prospect i ve cohorts , the Nurses ' Health Studies I ( n = 88,540 women ) and II ( n = 97,991 women ) and the Health Professionals ' Follow-Up Study ( n = 37,360 men ) . MEASUREMENTS Adjusted hazard ratios for incident clinical ly diagnosed hypertension . RESULTS Higher SSB and ASB intake was associated with an increased risk of developing hypertension in all three cohorts . In a pooled analysis , participants who consumed at least one SSB daily had an adjusted HR for incident hypertension of 1.13 ( 95 % CI , 1.09–1.17 ) compared with those who did not consume SSBs ; for persons who drank at least one ASB daily , the adjusted HR was 1.14 ( 95 % CI , 1.09–1.18 ) . The association between sweetened beverage intake and hypertension was stronger for carbonated beverages versus non-carbonated beverages , and for cola-containing versus non-cola beverages in the NHS I and NHS II cohorts only . Higher fructose intake from SSBs as a percentage of daily calories was associated with increased hypertension risk in NHS I and NHS II ( p-trend = 0.001 in both groups ) , while higher fructose intake from sources other than SSBs was associated with a decrease in hypertension risk in NHS II participants ( p-trend = 0.006 ) . LIMITATIONS Residual confounding factors may interfere with the interpretation of results . CONCLUSIONS SSBs and ASBs are independently associated with an increased risk of incident hypertension after controlling for multiple potential confounders . These associations may be mediated by factors common to both SSBs and ASBs ( e.g. , carbonation or cola ) , but are unlikely to be due to fructose",
"Background The replacement of sucrose with HFCS in food products has been suggested as playing a role in the development of obesity as a public health issue . The objective of this study was to examine the effects of four equally hypocaloric diets containing different levels of sucrose or high fructose corn syrup ( HFCS ) . Methods This was a r and omized , prospect i ve , double blind trial , with overweight/obese participants measured for body composition and blood chemistry before and after the completion of 12 weeks following a hypocaloric diet . The average caloric deficit achieved on the hypocaloric diets was 309 kcal . Results Reductions were observed in all measures of adiposity including body mass , BMI , % body fat , waist circumference and fat mass for all four hypocaloric groups , as well as reductions in the exercise only group for body mass , BMI and waist circumference . Conclusions Similar decreases in weight and indices of adiposity are observed when overweight or obese individuals are fed hypocaloric diets containing levels of sucrose or high fructose corn syrup typically consumed by adults in the United States",
"Both the amount and composition of food eaten influence body-weight regulation . The purpose of this study was to determine whether and by what mechanism excess dietary fat leads to greater fat accumulation than does excess dietary carbohydrate . We overfed isoenergetic amounts ( 50 % above energy requirements ) of fat and carbohydrate ( for 14 d each ) to nine lean and seven obese men . A whole-room calorimeter was used to measure energy expenditure and nutrient oxidation on days 0 , 1 , 7 , and 14 of each overfeeding period . From energy and nutrient balances ( intake-expenditure ) we estimated the amount and composition of energy stored . Carbohydrate overfeeding produced progressive increases in carbohydrate oxidation and total energy expenditure result ing in 75 - 85 % of excess energy being stored . Alternatively , fat overfeeding had minimal effects on fat oxidation and total energy expenditure , leading to storage of 90 - 95 % of excess energy . Excess dietary fat leads to greater fat accumulation than does excess dietary carbohydrate , and the difference was greatest early in the overfeeding period",
"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",
"Summary The effects of regularly eating sucrose were studied in 23 diabetic patients , 12 Type 1 ( insulin-dependent ) and 11 Type 2 ( non-insulin-dependent ) , with differing degrees of glycaemic control . Two diets , each lasting 6 weeks , were compared in a r and omised cross-over study . Both diets were high in fibre and low in fat . In one diet 45 g of complex carbohydrate was replaced by 45 g of sucrose taken at mealtimes . There were no significant biochemical differences between the two diets in either Type 1 or Type 2 patients . In Type 1 patients the mean ( ±SEM ) fasting plasma glucose was 10.5 ( 1.8 ) mmol/1 on the control diet and 10.3 ( 1.5 ) mmol/1 on sucrose . In Type 2 patients the levels were 9.1 ( 0.8 ) mmol/1 and 8.9 ( 0.8 ) mmol/l respectively . Glycosylated haemoglobin for the Type 1 patients was 9.9 % on control and 10.3 % on sucrose ; for Type 2 patients the figures were 9.3 % and 9.0 % respectively . There were no differences in mean daily plasma glucose levels or diurnal glucose profiles . Cholesterol ( total and in lipoprotein fractions ) was unchanged , as were diurnal triglyceride profiles and plasma insulin profiles in the Type 2 patients . There were no changes in medication or body weight . We conclude that a moderate amount of sucrose taken daily at mealtimes does not cause deterioration in metabolic control in diabetic patients following a high fibre/low fat diet",
"BACKGROUND Sugar-sweetened beverages are risk factors for type 2 diabetes ; however , the role of artificially sweetened beverages is unclear . OBJECTIVE The objective was to examine the associations of sugar- and artificially sweetened beverages with incident type 2 diabetes . DESIGN An analysis of healthy men ( n = 40,389 ) from the Health Professionals Follow-Up Study , a prospect i ve cohort study , was performed . Cumulatively averaged intakes of sugar-sweetened ( sodas , fruit punches , lemonades , fruit drinks ) and artificially sweetened ( diet sodas , diet drinks ) beverages from food-frequency question naires were tested for associations with type 2 diabetes by using Cox regression . RESULTS There were 2680 cases over 20 y of follow-up . After age adjustment , the hazard ratio ( HR ) for the comparison of the top with the bottom quartile of sugar-sweetened beverage intake was 1.25 ( 95 % CI : 1.11 , 1.39 ; P for trend high triglycerides at baseline , high blood pressure , diuretics , pre-enrollment weight change , dieting , total energy , and body mass index , the HR was 1.24 ( 95 % CI : 1.09 , 1.40 ; P for trend artificially sweetened beverages was significantly associated with type 2 diabetes in the age-adjusted analysis ( HR : 1.91 ; 95 % CI : 1.72 , 2.11 ; P for trend of sugar-sweetened beverage with 1 cup ( ≈237 mL ) of coffee was associated with a risk reduction of 17 % . CONCLUSION Sugar-sweetened beverage consumption is associated with a significantly elevated risk of type 2 diabetes , whereas the association between artificially sweetened beverages and type 2 diabetes was largely explained by health status , pre-enrollment weight change , dieting , and body mass index",
"Objective To examine the relation between intake of sugar sweetened soft drinks and fructose and the risk of incident gout in men . Design Prospect i ve cohort over 12 years . Setting Health professionals follow-up study . Participants 46 393 men with no history of gout at baseline who provided information on intake of soft drinks and fructose through vali date d food frequency question naires . Main outcome measure Incident cases of gout meeting the American College of Rheumatology survey criteria for gout . Results During the 12 years of follow-up 755 confirmed incident cases of gout were reported . Increasing intake of sugar sweetened soft drinks was associated with an increasing risk of gout . Compared with consumption of less than one serving of sugar sweetened soft drinks a month the multivariate relative risk of gout for 5 - 6 servings a week was 1.29 ( 95 % confidence interval 1.00 to 1.68 ) , for one serving a day was 1.45 ( 1.02 to 2.08 ) , and for two or more servings a day was 1.85 ( 1.08 to 3.16 ; P for trend=0.002 ) . Diet soft drinks were not associated with risk of gout ( P for trend=0.99 ) . The multivariate relative risk of gout according to increasing fifths of fructose intake were 1.00 , 1.29 , 1.41 , 1.84 , and 2.02 ( 1.49 to 2.75 ; P for trend risk of gout ( P values for trend sugar sweetened soft drinks and fructose is strongly associated with an increased risk of gout in men . Furthermore , fructose rich fruits and fruit juices may also increase the risk . Diet soft drinks were not associated with the risk of gout",
"BACKGROUND Consumption of sugar-sweetened beverages may cause excessive weight gain . We aim ed to assess the effect on weight gain of an intervention that included the provision of noncaloric beverages at home for overweight and obese adolescents . METHODS We r and omly assigned 224 overweight and obese adolescents who regularly consumed sugar-sweetened beverages to experimental and control groups . The experimental group received a 1-year intervention design ed to decrease consumption of sugar-sweetened beverages , with follow-up for an additional year without intervention . We hypothesized that the experimental group would gain weight at a slower rate than the control group . RESULTS Retention rates were 97 % at 1 year and 93 % at 2 years . Reported consumption of sugar-sweetened beverages was similar at baseline in the experimental and control groups ( 1.7 servings per day ) , declined to nearly 0 in the experimental group at 1 year , and remained lower in the experimental group than in the control group at 2 years . The primary outcome , the change in mean body-mass index ( BMI , the weight in kilograms divided by the square of the height in meters ) at 2 years , did not differ significantly between the two groups ( change in experimental group minus change in control group , -0.3 ; P=0.46 ) . At 1 year , however , there were significant between-group differences for changes in BMI ( -0.57 , P=0.045 ) and weight ( -1.9 kg , P=0.04 ) . We found evidence of effect modification according to ethnic group at 1 year ( P=0.04 ) and 2 years ( P=0.01 ) . In a prespecified analysis according to ethnic group , among Hispanic participants ( 27 in the experimental group and 19 in the control group ) , there was a significant between-group difference in the change in BMI at 1 year ( -1.79 , P=0.007 ) and 2 years ( -2.35 , P=0.01 ) , but not among non-Hispanic participants ( P>0.35 at years 1 and 2 ) . The change in body fat as a percentage of total weight did not differ significantly between groups at 2 years ( -0.5 % , P=0.40 ) . There were no adverse events related to study participation . CONCLUSIONS Among overweight and obese adolescents , the increase in BMI was smaller in the experimental group than in the control group after a 1-year intervention design ed to reduce consumption of sugar-sweetened beverages , but not at the 2-year follow-up ( the prespecified primary outcome ) . ( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; Clinical Trials.gov number , NCT00381160 . )",
"BACKGROUND Consumption of sugar-sweetened soda has been associated with an increased risk of cardiometabolic disease . The relation with cerebrovascular disease has not yet been closely examined . OBJECTIVE Our objective was to examine patterns of soda consumption and substitution of alternative beverages for soda in relation to stroke risk . DESIGN The Nurses ' Health Study , a prospect i ve cohort study of 84,085 women followed for 28 y ( 1980 - 2008 ) , and the Health Professionals Follow-Up Study , a prospect i ve cohort study of 43,371 men followed for 22 y ( 1986 - 2008 ) , provided data on soda consumption and incident stroke . RESULTS We documented 1416 strokes in men during 841,770 person-years of follow-up and 2938 strokes in women during 2,188,230 person-years of follow-up . The pooled RR of total stroke for ≥ 1 serving of sugar-sweetened soda/d , compared with none , was 1.16 ( 95 % CI : 1.00 , 1.34 ) . The pooled RR of total stroke for ≥ 1 serving of low-calorie soda/d , compared with none , was 1.16 ( 95 % CI : 1.05 , 1.28 ) . Compared with 1 serving of sugar-sweetened soda/d , 1 serving of decaffeinated coffee/d was associated with a 10 % ( 95 % CI : 1 % , 19 % ) lower risk of stroke and 1 serving of caffeinated coffee/d with a 9 % ( 95 % CI : 0 % , 17 % ) lower risk . Similar estimated reductions in risk were seen for substitution of caffeinated or decaffeinated coffee for low-calorie soda . CONCLUSIONS Greater consumption of sugar-sweetened and low-calorie sodas was associated with a significantly higher risk of stroke . This risk may be reduced by substituting alternative beverages for soda",
"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",
"Overtly hypertriglyceridemic patients with non-insulin-dependent diabetes mellitus were given a control diet containing 120 g of sucrose and 50 percent carbohydrate , and later r and omly assigned to receive isocaloric high- ( 220 g ) , intermediate- ( 120 g ) , or low- ( less than 3 g ) sucrose/carbohydrate diets for four weeks . The low-sucrose diet group demonstrated a modest but significant decrease in mean fasting serum glucose level in the first week only , although this change was no different from the other two dietary groups and was not sustained . All groups had little change in late postpr and ial serum glucose levels from control values , and no significant alterations in 24-hour glycosuria . The high-sucrose diet group demonstrated a significant increase in fasting serum triglyceride levels by the second week of the study , whereas the intermediate- and low-sucrose diet groups showed a decrease in mean fasting triglyceride levels . In contrast , the low-sucrose diet group 's late postpr and ial serum triglyceride levels increased by the fourth week , whereas levels fell in the high-sucrose diet group . Mean fasting serum cholesterol concentrations decreased from control values in the high-sucrose diet group . Thus , although very high sucrose and carbohydrate consumption is clearly deleterious to fasting tryglyceride levels in non-insulin-dependent diabetes mellitus with preexisting hypertriglyceridemia , it appears that low dietary sucrose and carbohydrate proportions do not further improve prepr and ial glycemia and glycosuria and may adversely affect late postpr and ial serum triglyceride concentration . This study suggests that isocaloric sucrose and carbohydrate restriction below usual daily levels ( 120 g per day ) offers no consistent benefit in glycemia or lipid control in overt type II diabetes",
"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",
"The authors analyzed data from a prospect i ve , community-based cohort to assess the risk of incident type 2 diabetes mellitus associated with coffee and sweetened beverage consumption . They included 12,204 nondiabetic , middle-aged men and women in the Atherosclerosis Risk in Communities ( ARIC ) Study ( 1987 - 1999 ) . Consumption of each beverage was assessed by food frequency question naire and classified into categories of cups per day . They found an inverse association , after adjusting for potential confounders , between increased coffee consumption and risk of type 2 diabetes mellitus in men ( for > or = 4 cups ( > or = 0.95 liter)/day compared with almost never : hazard ratio = 0.77 , p(trend ) = 0.02 ) with no significant association in women ( hazard ratio = 0.89 , p(trend ) = 0.32 ) using a combination of self-report of physician-diagnosed diabetes , diabetes treatment , and a fasting or nonfasting blood glucose test . When self-reported diabetes or diabetes treatment alone was used , a stronger and significant inverse association was seen in men and women . Sweetened beverage consumption ( men : hazard ratio = 1.03 , p(trend ) = 0.94 ; women : hazard ratio = 1.01 , p(trend ) = 0.58 ) showed no consistent association with the incidence of type 2 diabetes mellitus . In summary , increased coffee consumption was significantly associated with a decreased risk of diagnosed type 2 diabetes mellitus in community-based US adults",
"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",
"BACKGROUND Weight loss reduces body fat and lean mass , but whether these changes are influenced by macronutrient composition of the diet is unclear . OBJECTIVE We determined whether energy-reduced diets that emphasize fat , protein , or carbohydrate differentially reduce total , visceral , or hepatic fat or preserve lean mass . DESIGN In a subset of participants in a r and omized trial of 4 weight-loss diets , body fat and lean mass ( n = 424 ; by using dual-energy X-ray absorptiometry ) and abdominal and hepatic fat ( n = 165 ; by using computed tomography ) were measured after 6 mo and 2 y. Changes from baseline were compared between assigned amounts of protein ( 25 % compared with 15 % ) and fat ( 40 % compared with 20 % ) and across 4 carbohydrate amounts ( 35 % through 65 % ) . RESULTS At 6 mo , participants lost a mean ( ±SEM ) of 4.2 ± 0.3 kg ( 12.4 % ) fat and 2.1 ± 0.3 kg ( 3.5 % ) lean mass ( both P ) abdominal fat : 1.5 ± 0.2 kg ( 13.6 % ) subcutaneous fat and 0.9 ± 0.1 kg ( 16.1 % ) visceral fat ( all P Women lost more visceral fat than did men relative to total-body fat loss . Participants regained ~40 % of these losses by 2 y , with no differences between diets ( P ≥ 0.23 ) . Weight loss reduced hepatic fat , but there were no differences between groups ( P ≥ 0.28 ) . Dietary goals were not fully met ; self-reported contrasts were closer to 2 % protein , 8 % fat , and 14 % carbohydrate at 6 mo and 1 % , 7 % , and 10 % , respectively , at 2 y. CONCLUSION Participants lost more fat than lean mass after consumption of all diets , with no differences in changes in body composition , abdominal fat , or hepatic fat between assigned macronutrient amounts . This trial was registered at clinical trials.gov as NCT00072995",
"In animal models , a small ( catalytic ) dose of fructose administered with glucose decreases the glycemic response to the glucose load . Therefore , we examined the effect of fructose on glucose tolerance in 11 healthy human volunteers ( 5 men and 6 women ) . Each subject underwent an oral glucose tolerance test ( OGTT ) on 2 separate occasions , at least 1 week apart . Each OGTT consisted of 75 g glucose with or without 7.5 g fructose ( OGTT+F or OGTT-F ) , in r and om order . Arterialized blood sample s were obtained from a heated dorsal h and vein twice before ingestion of the carbohydrate and every 15 min for 2 h afterward . The area under the curve ( AUC ) of the change in plasma glucose was 19 % less in OGTT+F vs. OGTT-F ( P : Glucose tolerance was improved by fructose in 9 subjects and worsened in 2 . All 6 subjects with the largest glucose AUC during OGTT-F had a decreased response during OGTT+F ( 31 + /- 5 % decrease ) . The insulin AUC did not differ between the 2 studies . Of the 9 subjects with improved glucose tolerance during the OGTT+F , 5 had smaller insulin AUC during the OGTT+F than the OGTT-F. Plasma glucagon concentrations declined similarly during OGTT-F and OGTT+F. The blood lactate response was about 50 % greater during the OGTT+F ( P : nonesterified fatty acid nor triglyceride concentrations differed between the two OGTT . In conclusion , low dose fructose improves the glycemic response to an oral glucose load in normal adults without significantly enhancing the insulin or triglyceride response . Fructose appears most effective in those normal individuals who have the poorest glucose tolerance",
"Abstract 51 healthy office workers , aged 36 - 55 , volunteered for a dietary experiment . A third of them were asked to cut out sucrose and replace it with other foods . Another third tried to halve their dietary starch and substitute other foods . The remainder were controls who continued their usual diets . In the low-sugar group , serum-triglycerides showed a significant decrease which persisted until the diets were stopped after 51/2 months ; triglycerides fell more in those who had higher levels to start with . The reduction of serum-triglycerides can be attributed , at least partly , to weight-loss . Serum-lipids did not change significantly in the reduced-starch group , but these subjects had more difficulty following their prescribed diet and did not lose weight",
"Higher uric acid levels are associated with an increased risk for developing hypertension . Higher intake of fructose increases plasma uric acid levels and higher intake of vitamin C reduces uric acid levels , but whether these nutrients are independently associated with the risk for developing hypertension is unknown . We studied this question by analyzing data from participants of three large and independent prospect i ve cohorts : Nurses ' Health Study 1 ( n = 88,540 ) , Nurses ' Health Study 2 ( n = 97,315 ) , and the Health Professionals Follow-up Study ( n = 37,375 ) . Relative risks and 95 % confidence intervals for incident hypertension were computed according to quintiles of fructose intake and categories of vitamin C intake using multivariable Cox proportional hazards regression . Fructose intake was not associated with the risk for developing hypertension ; the multivariable relative risks ( 95 % confidence intervals ) for the highest compared with the lowest quintile of fructose intake were 1.02 ( 0.99 to 1.06 ) in Nurses ' Health Study 1 , 1.03 ( 0.98 to 1.08 ) in Nurses ' Health Study 2 , and 0.99 ( 0.93 to 1.05 ) in Heath Professionals Follow-up Study . Regarding vitamin C , the relative risks for individuals who consumed > or = 1500 mg/d compared with those who consumed fructose and vitamin C intake do not substantially influence the risk for developing hypertension",
"Abstract Objective : To study the effects of snacking based on fast acting carbohydrates ( c and y ) or fat and protein ( peanuts ) in a prospect i ve r and omized , parallel intervention study . Methods : Basal metabolic rate ( BMR ) and cardiovascular risk factors were measured before and after hyper-alimentation by addition of 20kcal/kg ( 84kJ/kg ) body weight of either c and y or roasted peanuts , to the regular caloric intake , for two weeks in healthy subjects . Eleven men and 14 women completed the r and omized study . Results : Energy-intake increased similarly in the groups ( c and y : + 46.1±35 % , peanuts : + 46.8±28 % p=0.96 ) . Body-weight ( c and y : from 67.3±7.6 kg to 68.1±7.3 kg , p=0.01 , nuts : from 68.7±6.1 kg to 69.0±5.7 kg p=0.3 ) and waist circumference increased significantly only in the c and y group . At the end of the study LDL cholesterol ( c and y : 2.6±0.4mmol/l peanuts : 2.1±0.4mmol/l , p=0.005 ) and ApoB/ApoA-1-ratio ( c and y : 0.68±0.16 peanuts 0.53±0.11 , p=0.01 ) were higher in the c and y group than in the peanut group . On the other h and , BMR increased only in the peanut group ( c and y : from 6.657±1.1MJ/24h to 6.762±1.1MJ/24h , p=0.3 nuts : from 6.896±0.98MJ/24h to 7.256±1.1MJ/24h , p=0.02 ) . Conclusion : Two weeks of snacking based on peanuts does not cause the same negative metabolic effects as an isocaloric diet in which the snacking is based on short acting carbohydrates in the form of c and y in non-obese healthy subjects",
"CONTEXT Fructose-rich beverages such as sugar-sweetened soda and orange juice can increase serum uric acid levels and , thus , the risk of gout , but prospect i ve data on the relationship are limited . OBJECTIVE To examine the relationship between intake of fructose-rich beverages and fructose and the risk of incident gout among women . DESIGN , SETTING , AND PARTICIPANTS In the Nurses ' Health Study , a US prospect i ve cohort study spanning 22 years ( 1984 - 2006 ) , we analyzed data from 78,906 women with no history of gout at baseline who provided information on intake of beverages and fructose through vali date d food frequency question naires . MAIN OUTCOME MEASURE Incident cases that met the American College of Rheumatology survey criteria for gout . RESULTS During 22 years of follow-up , we documented 778 confirmed incident cases of gout . Increasing intake of sugar-sweetened soda was independently associated with increasing risk of gout . Compared with consumption of less than 1 serving per month of sugar-sweetened soda , the multivariate relative risk of gout for 1 serving per day was 1.74 ( 95 % confidence interval [ CI ] , 1.19 - 2.55 ) and for 2 or more servings per day was 2.39 ( 95 % CI , 1.34 - 4.26 ) ( P absolute risk differences corresponding to these relative risks were 36 and 68 cases per 100,000 person-years for sugar-sweetened soda and 14 and 47 cases per 100,000 person-years for orange juice , respectively . Diet soft drinks were not associated with the risk of gout ( P = .27 for trend ) . Compared with the lowest quintile of fructose intake , the multivariate relative risk of gout in the top quintile was 1.62 ( 95 % CI , 1.20 - 2.19 ; P = .004 for trend ) ( risk difference of 28 cases per 100,000 person-years ) . CONCLUSION Among this cohort of women , consumption of fructose-rich beverages is associated with an increased risk of incident gout , although the contribution of these beverages to the risk of gout in the population is likely modest given the low incidence rate among women"
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• STUDY DESIGN : Systematic review with meta‐ analysis . • BACKGROUND : The addition of hip strengthening to knee strengthening for persons with patellofemoral pain has the potential to optimize treatment effects . There is a need to systematic ally review and pool the current evidence in this area . • OBJECTIVE : To examine the efficacy of hip strengthening , associated or not with knee strengthening , to increase strength , reduce pain , and improve activity in individuals with patellofemoral pain . • METHODS : A systematic review of r and omized and /or controlled trials was performed . Participants in the review ed studies were individuals with patellofemoral pain , and the experimental intervention was hip and knee strengthening . Outcome data related to muscle strength , pain , and activity were extracted from the eligible trials and combined in a meta‐ analysis . • RESULTS : The review included 14 trials involving 673 participants . R and om‐effects meta‐analyses revealed that hip and knee strengthening decreased pain ( mean difference , ‐3.3 ; 95 % confidence interval [ CI ] : ‐5.6 , ‐1.1 ) and improved activity ( st and ardized mean difference , 1.4 ; 95 % CI : 0.03 , 2.8 ) compared to no training/placebo . In addition , hip and knee strengthening was superior to knee strengthening alone for decreasing pain ( mean difference , ‐1.5 ; 95 % CI : ‐2.3 , ‐0.8 ) and improving activity ( st and ardized mean difference , 0.7 ; 95 % CI : 0.2 , 1.3 ) . Results were maintained beyond the intervention period . Meta‐analyses showed no significant changes in strength for any of the interventions . • CONCLUSION : Hip and knee strengthening is effective and superior to knee strengthening alone for decreasing pain and improving activity in persons with patellofemoral pain ; however , these outcomes were achieved without a concurrent change in strength . • LEVEL OF EVIDENCE : Therapy , level
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"BACKGROUND / AIM The role of hip muscles in the rehabilitation of patellofemoral pain syndrome has recently received interest . The aim of this study was to compare the efficiencies of hip exercises alongside knee exercises versus only knee exercises on pain , function , and isokinetic muscle strength in patients with this syndrome . MATERIAL S AND METHODS Fifty-five young female patients ( mean age : 34.1 ± 6.2 years ; mean BMI : 25.9 ± 3.9 kg/m2 ) with patellofemoral pain syndrome were included . The patients were r and omized into groups of hip- and -knee exercises and knee-only exercise programs for 6 weeks with a total of 30 sessions at the clinic . Both groups were evaluated before therapy , after 6 weeks of a supervised exercise program , and after 6 weeks of an at-home exercise program . The outcome measures were muscle strength , pain , and both subjective and objective function . RESULTS The improvements of the patients in the hip- and -knee exercise group were better than in patients of the knee-only exercise group in terms of scores of pain relief ( P and functional gain ( P = 0.002 ) after 12 weeks . CONCLUSION We suggest additional hip-strengthening exercises to patients with patellofemoral pain syndrome in order to decrease pain and increase functional status",
"Patello-femoral pain syndrome ( PFPS ) is a common knee joint disability . The integration of hip soft tissue regimens are not always emphasized , although current literature implies that there is a significant relationship between the two and there is a lack of r and omized clinical trials to substantiate this relationship in clinical practice . A r and omized controlled assessor blinded trial was design ed to explore different rehabilitation programs related to PFPS . The study was conducted at RAZIEL institute of physical therapy , Netania , Israel with a total of 30 consecutive patients ( mean age 35y ) , diagnosed with PFPS . All patients were r and omly allocated into 3 groups . Group I conventional knee rehabilitation program . Included quadriceps strengthening and Trans Electric Neuromuscular Stimulation ( TENS ) . Group II hip oriented rehabilitation program . included stretching , Hip external rotators strengthening and TENS . Group III a combination of the two above programs . Pain and function were documented on initial of the program and again 3 weeks later , on the completion . Pain was assessed by a numeric visual analogue scale ( VAS ) ; function was assessed by Patello-femoral joint evaluation scale ( PFJES ) ( 0 - 100 points ) . At end of trial , all groups showed significant improvements in VAS and PFJES ( p<0.0001 ) ; these improvements did not vary significantly between the 3 groups . The conclusions were that the explored different rehabilitation programs showed a similar beneficial effect",
"STUDY DESIGN R and omized controlled trial . OBJECTIVES To determine if adding hip-strengthening exercises to a conventional knee exercise program produces better long-term outcomes than conventional knee exercises alone in women with patellofemoral pain syndrome ( PFPS ) . BACKGROUND Recent studies have shown that a hip-strengthening program reduces pain and improves function in individuals with PFPS . However , there are no clinical trials evaluating long-term outcomes of this type of program compared to conventional knee-strengthening and -stretching exercises . METHODS Fifty-four sedentary women between 20 and 40 years of age , with a diagnosis of unilateral PFPS , were r and omly assigned knee exercise ( KE ) or knee and hip exercise ( KHE ) . The women in the KE group ( n = 26 ; mean age , 23 years ) performed a 4-week conventional knee-stretching and -strengthening program . The women in the KHE group ( n = 28 ; mean age , 22 years ) performed the same exercises as those in the KE group , as well as strengthening exercises for the hip abductors , lateral rotators , and extensors . An 11-point numeric pain rating scale , the Lower Extremity Functional Scale , the Anterior Knee Pain Scale , and a single-hop test were used as outcome measures at baseline ( pretreatment ) and 3 , 6 , and 12 months posttreatment . RESULTS At baseline , demographic , pain , and functional assessment data were similar between groups . Those in the KHE group had a higher level of function and less pain at 3 , 6 , and 12 months compared to baseline ( P reduced pain only at the 3- and 6-month follow-ups ( P Lower Extremity Functional Scale , Anterior Knee Pain Scale , or hop testing ( P>.05 ) through the course of the study . Compared to the KE group , the KHE group had less pain and better function at 3 , 6 , and 12 months posttreatment ( P Knee-stretching and -strengthening exercises supplemented by hip posterolateral musculature-strengthening exercises were more effective than knee exercises alone in improving long-term function and reducing pain in sedentary women with PFPS",
"STUDY DESIGN R and omized clinical trial . OBJECTIVE To investigate the influence of strengthening the hip abductor and lateral rotator musculature on pain and function of females with patellofemoral pain syndrome ( PFPS ) . BACKGROUND Hip muscle weakness in women athletes has been the focus of many recent studies and is suggested as an important impairment to address in the conservative treatment of women with PFPS . However , it is still not well established if strengthening these muscles is associated with clinical improvement in pain and function in sedentary females with PFPS . METHODS Seventy females ( average±SD age , 25±07 years ) , with a diagnosis of unilateral PFPS , were distributed r and omly into 3 groups : 22 females in the knee exercise group , who received a conventional treatment that emphasized stretching and strengthening of the knee musculature ; 23 females in the knee and hip exercise group , who performed exercises to strengthen the hip abductors and external rotators in addition to the same exercises performed by those in the knee exercise group ; and of the 25 females who did not receive any treatment . The females of the nontreatment group ( control ) were instructed to maintain their normal daily activities . An 11-point numerical pain rating scale ( NPRS ) was used to assess pain during stair ascent and descent . The lower extremity functional scale ( LEFS ) and the anterior knee pain scale ( AKPS ) were used to assess function . The single-limb single hop test was also used as a functional outcome to measure preintervention and 4-week postintervention function . RESULTS The 3 groups were homogeneous prior to treatment in respect to demographic , pain , and functional scales data . Both the knee exercise and the knee and hip exercise groups showed significant improvement in the LEFS , the AKPS , and the NPRS , when compared to the control group ( P the knee and hip exercise group demonstrated mean improvements in AKPS and pain scores that were large enough to be clinical ly meaningful . For the single-limb single hop test , both groups receiving an intervention showed greater improvement than the control group , but there was no difference between the 2 interventions ( P>.05 ) . CONCLUSION Rehabilitation programs focusing on knee strengthening exercises and knee strengthening exercises supplemented by hip strengthening exercises were both effective in improving function and reducing pain in sedentary women with PFPS . Improvements of pain and function were greater for the group that performed the hip strengthening exercises , but the difference was significant only for pain rating while descending stairs . LEVEL OF EVIDENCE Therapy , level 1b-",
"STUDY DESIGN R and omized clinical trial . OBJECTIVES To compare the effects of functional stabilization training ( FST ) versus st and ard training on knee pain and function , lower-limb and trunk kinematics , trunk muscle endurance , and eccentric hip and knee muscle strength in women with patellofemoral pain . BACKGROUND A combination of hip- and knee-strengthening exercise may be more beneficial than quadriceps strengthening alone to improve pain and function in individuals with patellofemoral pain . However , there is limited evidence of the effectiveness of these exercise programs on the biomechanics of the lower extremity . METHODS Thirty-one women were r and omized to either the FST group or st and ard-training group . Patients attended a baseline assessment session , followed by an 8-week intervention , and were reassessed at the end of the intervention and at 3 months after the intervention . Assessment measures were a 10-cm visual analog scale for pain , the Lower Extremity Functional Scale , and the single-leg triple-hop test . A global rating of change scale was used to measure perceived improvement . Kinematics were assessed during the single-leg squat . Outcome measures also included trunk endurance and eccentric hip and knee muscle strength assessment . RESULTS The patients in the FST group had less pain at the 3-month follow-up and greater global improvement and physical function at the end of the intervention compared to those in the st and ard-training group . Lesser ipsilateral trunk inclination , pelvis contralateral depression , hip adduction , and knee abduction , along with greater pelvis anteversion and hip flexion movement excursions during the single-leg squat , were only observed in the FST group after the intervention . Only those in the FST group had greater eccentric hip abductor and knee flexor strength , as well as greater endurance of the anterior , posterior , and lateral trunk muscles , after training . CONCLUSION An intervention program consisting of hip muscle strengthening and lower-limb and trunk movement control exercises was more beneficial in improving pain , physical function , kinematics , and muscle strength compared to a program of quadriceps-strengthening exercises alone",
"CONTEXT Patellofemoral pain ( PFP ) is the most common injury in running and jumping athletes . R and omized controlled trials suggest that incorporating hip and core strengthening ( HIP ) with knee-focused rehabilitation ( KNEE ) improves PFP outcomes . However , no r and omized controlled trials have , to our knowledge , directly compared HIP and KNEE programs . OBJECTIVE To compare PFP pain , function , hip- and knee-muscle strength , and core endurance between KNEE and HIP protocol s after 6 weeks of rehabilitation . We hypothesized greater improvements in ( 1 ) pain and function , ( 2 ) hip strength and core endurance for patients with PFP involved in the HIP protocol , and ( 3 ) knee strength for patients involved in the KNEE protocol . DESIGN R and omized controlled clinical trial . SETTING Four clinical research laboratories in Calgary , Alberta ; Chicago , Illinois ; Milwaukee , Wisconsin ; and Augusta , Georgia . PATIENTS OR OTHER PARTICIPANTS Of 721 patients with PFP screened , 199 ( 27.6 % ) met the inclusion criteria ( 66 men [ 31.2 % ] , 133 women [ 66.8 % ] , age = 29.0 ± 7.1 years , height = 170.4 ± 9.4 cm , weight = 67.6 ± 13.5 kg ) . INTERVENTION(S ) Patients with PFP were r and omly assigned to a 6-week KNEE or HIP protocol . MAIN OUTCOME MEASURE(S ) Primary variables were self-reported visual analog scale and Anterior Knee Pain Scale measures , which were conducted weekly . Secondary variables were muscle strength and core endurance measured at baseline and at 6 weeks . RESULTS Compared with baseline , both the visual analog scale and the Anterior Knee Pain Scale improved for patients with PFP in both the HIP and KNEE protocol s ( P visual analog scale scores for those in the HIP protocol were reduced 1 week earlier than in the KNEE group . Both groups increased in strength ( P in hip-abductor ( P = .01 ) and -extensor ( P = .01 ) strength and posterior core endurance ( P = .05 ) compared with the KNEE group . CONCLUSIONS Both the HIP and KNEE rehabilitation protocol s produced improvements in PFP , function , and strength over 6 weeks . Although outcomes were similar , the HIP protocol result ed in earlier resolution of pain and greater overall gains in strength compared with the KNEE protocol",
"OBJECTIVE To compare the efficacy of posterolateral hip muscle strengthening versus quadriceps strengthening in reducing pain and improving health status in persons with patellofemoral pain ( PFP ) . DESIGN Comparative control trial . SETTING Rehabilitation facility . PARTICIPANTS Persons with a diagnosis of PFP ( N=36 ; 18 men , 18 women ) . INTERVENTIONS Patients were alternately assigned to a posterolateral hip muscle strengthening group ( 9 men and 9 women ) or a quadriceps strengthening group ( 9 men and 9 women ) . The posterolateral hip muscle strengthening group performed hip abductor and external rotator strengthening exercises , whereas the quadriceps strengthening group performed quadriceps strengthening exercises ( 3 times a week for 8wk ) . MAIN OUTCOME MEASURES Pain ( visual analog scale [ VAS ] ) and health status ( Western Ontario McMaster Universities Osteoarthritis Index [ WOMAC ] ) were assessed at baseline , postintervention , and 6-month follow-up . RESULTS Significant improvements in VAS and WOMAC scores were observed in both groups from baseline to postintervention and baseline to 6-month follow-up ( P VAS and WOMAC scores in the posterolateral hip exercise group were superior to those in the quadriceps exercise group postintervention and at 6-month follow-up ( P pain and improved function in persons with PFP , outcomes in the posterolateral hip exercise group were superior to the quadriceps exercise group . The superior outcomes obtained in the posterolateral hip exercise group were maintained 6 months postintervention",
"STUDY DESIGN R and omized clinical trial . OBJECTIVES To determine if females with patellofemoral pain syndrome ( PFPS ) who perform hip strengthening prior to functional exercises demonstrate greater improvements than females who perform quadriceps strengthening prior to the same functional exercises . BACKGROUND Although PFPS has previously been attributed to quadriceps dysfunction , more recent research has linked this condition to impairment of the hip musculature . Lower extremity strengthening has been deemed an effective intervention . However , research has often examined weight-bearing exercises , making it unclear if increased strength in the hip , quadriceps , or both is beneficial . METHODS Thirty-three females with PFPS performed either initial hip strengthening ( hip group ) or initial quadriceps strengthening ( quad group ) for 4 weeks , prior to 4 weeks of a similar program of functional weight-bearing exercises . Self-reported pain , function , and functional strength were measured . Isometric strength was assessed for hip abductors , external rotators , and knee extensors . A mixed-model analysis of variance was used to determine group differences over time . RESULTS After 4 weeks , there was less mean ± SD pain in the hip group ( 2.4 ± 2.0 ) than in the quad group ( 4.1 ± 2.5 ) ( P = .035 ) . From baseline to 8 weeks , the hip group demonstrated a 21 % increase ( P in hip abductor strength , while that remained unchanged in the quad group . All participants demonstrated improved subjective function ( P , objective function ( P ) , and hip external rotator strength ( P = .004 ) from baseline to testing at 8 weeks . CONCLUSION Both rehabilitation approaches improved function and reduced pain . For patients with PFPS , initial hip strengthening may allow an earlier dissipation of pain than exercises focused on the quadriceps",
"Background Since knee complaints are common among athletes and are frequently presented in general practice , it is of interest to investigate the type of knee complaints represented in general practice of athletes in comparison with those of non-athletes . Therefore , the aim of this study is to investigate the differences in type of knee complaints between sport participants , in this study defined as athletes , and non-sport participants , defined as non-athletes , presenting in general practice . Further , differences in the initial policy of the GP , medical consumption , and outcome at one-year follow-up were also investigated . Methods Patients consulting their GP for a new episode of knee complaints were invited to participate in this prospect i ve cohort study . From the total HONEUR knee cohort population ( n = 1068 ) we extracted patients who were athletes ( n = 421 ) or non-athletes ( n = 388 ) . Results The results showed that acute distortions of the knee were significantly more diagnosed in athletes than in non-athletes ( p = 0.04 ) . Further , more athletes were advised by their GP to ' go easy on the knee ' than the non-athletes ( p of referrals and medication prescribed by the GP . The medical consumption was significantly higher among athletes ; however , no significant differences were found between the two groups for recovery at one-year follow-up . Conclusion There are no major differences in the diagnosis and prognosis of knee complaints between athletes and non-athletes presented to the GP . This implies that there are no indications for different treatment strategies applied in both groups . However , athletes are more often advised to ' go easy on the knee ' and to rest than non-athletes . Further , there is a trend towards increased medical consumption among athletes while functional disability and pain are lower than among the non-athletes",
"Background Patellofemoral pain syndrome is one of the most common chronic knee injuries ; however , little research has been done to determine the risk factors for this injury . Hypothesis Altered lower extremity kinematics and kinetics , decreased strength , and altered postural measurements will be risk factors . Study Design Cohort study ( prognosis ) ; Level of evidence , 2 . Methods A total of 1597 participants were enrolled in this investigation and prospect ively followed from the date of their enrollment ( July 2005 , July 2006 , or July 2007 ) through January 2008 , a maximum of 2.5 years of follow-up . Each participant underwent baseline data collection during their pre-freshman summer at the United States Naval Academy . Baseline data collection included 3-dimensional motion analysis during a jump-l and ing task , 6 lower extremity isometric strength tests , and postural alignment measurements ( navicular drop and Q angle ) . Results Risk factors for the development of patellofemoral pain syndrome included decreased knee flexion angle , decreased vertical ground-reaction force , and increased hip internal rotation angle during the jump-l and ing task . Additionally , decreased quadriceps and hamstring strength , increased hip external rotator strength , and increased navicular drop were risk factors for the development of patellofemoral pain syndrome . Conclusion Multiple modifiable risk factors for patellofemoral pain syndrome pain have been identified in this investigation . To decrease the incidence of this chronic injury , the risk factors for patellofemoral pain syndrome need to be targeted in injury prevention programs . Clinical Relevance Prevention programs should focus on increasing strength of the lower extremity musculature along with instructing proper mechanics during dynamic movements to decrease the incidence of patellofemoral pain syndrome",
"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 .",
"Objective Patellar malalignment is a major cause of patellofemoral pain syndrome ( PFPS ) , but the relationship between clinical symptoms and changes in patellar position and knee muscle strength has not been confirmed . This study examined the effect of weight training on hip and knee muscle strength , patellofemoral joint contact area , and patellar tilt on subjects with and without PFPS , hoping to develop an optimal rehabilitation protocol for subjects with PFPS . Design The study uses a prospect i ve independent group comparison . Fifteen subjects with and without PFPS were assessed for knee strength , patellofemoral joint contact area , and patellar tilt angle using magnetic resonance imaging . The subjects with PFPS were also examined and given a numeric pain rating score and a Kujala patellofemoral score . The subjects performed lower-limb weight training 3 times/wk for 8 wks , and the outcomes were assessed both before and after training . Results Subjects with PFPS have increased their patellofemoral joint contact area after weight training ( P patellar tilt angle . The isometric and isokinetic knee strength in subjects with and without PFPS have increased after weight training ( P value increased from 0.007 to 0.05 ) . Both numeric pain rating and Kujala patellofemoral score in the PFPS group improved after training ( P Weight-training exercise increased knee muscle strength and the patellofemoral joint contact area , which could reduce mechanical stress in the joint , improving pain and function in subjects with PFPS",
"OBJECTIVE To determine the efficacy of the individual components of physiotherapy in subjects with anterior knee pain . METHODS An observer blind , prospect i ve , factorial design r and omised controlled trial . 81 young adults with anterior knee pain were r and omly allocated to one of four treatment groups : ( 1 ) exercise , taping , and education ; ( 2 ) exercise and education ; ( 3 ) taping and education ; and ( 4 ) education alone . Each group received six physiotherapist-led treatments over three months . Follow up took place at three months using the following outcome measures : patient satisfaction ( discharge/refer for further treatment ) ; a visual analogue pain score ; the WOMAC lower limb function score ; the Hospital Anxiety and Depression scale ( HAD ) ; and quadriceps strength . At 12 months the WOMAC and HAD were assessed by postal question naire . RESULTS All groups showed significant improvements in WOMAC , visual analogue , and HAD scores ; these improvements did not vary significantly between the four groups or between exercising/non-exercising and taped/non-taped patients at three and 12 months . However , patients who exercised were significantly more likely to be discharged at three months than non-exercising patients ( χ2 , p with discharge . Significantly greater improvements in WOMAC , visual analogue , and the anxiety score ( but not the depression score ) were seen in patients who were discharged than in those who were referred . CONCLUSIONS The proprioceptive muscle stretching and strengthening aspects of physiotherapy have a beneficial effect at three months sufficient to permit discharge from physiotherapy . These benefits are maintained at one year . Taping does not influence the outcome",
"Objective : To determine the effectiveness of patellar bracing for treatment of patellofemoral pain syndrome ( PFPS ) . Design : Prospect i ve , r and omized , single-blinded clinical trial . Setting : Subjects recruited from the general population of the city of Calgary . Subjects : A total of 136 subjects ( 79 females and 57 males with a total of 197 affected knees ) diagnosed with PFPS . Intervention : Subjects were r and omly assigned to 1 of 4 treatment groups : ( 1 ) home exercise program , ( 2 ) patellar bracing , ( 3 ) home exercise program with patellar bracing , and ( 4 ) home exercise program with knee sleeve . Outcome Measures : The outcome measurements were knee function ( KF ) and 10-cm visual analogue scale ( VAS ) pain ratings for 3 different situations : knee pain during sport activity , knee pain 1 hour after sport activity , and knee pain after sitting with knees bent for 30 minutes . The outcome measurements were assessed at baseline and at 3 , 6 , and 12 weeks . The investigators were blinded to the treatment group of each subject . Calculations were made for 95 % confidence intervals for the change in KF and VAS pain ratings from baseline measurement to 12 weeks . Results : There was no difference in the 95 % confidence intervals in the change of KF and VAS pain ratings among the 4 treatment groups over 12 weeks . Conclusions : Symptoms of PFPS improved over time in terms of pain and knee function regardless of the treatment group . Patellar bracing did not improve the symptoms of PFPS more quickly when added to a home program of leg strengthening . However , patellar bracing alone can improve the symptoms of PFPS",
"PURPOSE Patellofemoral pain ( PFP ) is the leading cause of knee pain in runners . Proximal and distal running mechanics have been linked to the development of PFP . However , the lack of prospect i ve studies limits establishing a causal relationship of these mechanics to PFP . The purpose of this study was to prospect ively compare running mechanics in a group of female runners who went on to develop PFP compared with healthy controls . It was hypothesized that runners who go on to develop PFP would exhibit greater hip adduction , hip internal rotation , and greater rear foot eversion . METHODS Four hundred healthy female runners underwent an instrumented gait analysis and were then tracked for any injuries that they may have developed over a 2-yr period . Fifteen cases of PFP developed , which were confirmed by a medical professional . Their initial running mechanics were compared to an equal number of runners who remained uninjured . RESULTS We found that female runners who developed PFP exhibited significantly greater hip adduction ( P = 0.007 ) . No statistically significant differences were found for the hip internal rotation angle ( P = 0.47 ) or rear foot eversion ( P = 0.1 ) . CONCLUSIONS The finding of greater hip adduction in female runners who develop PFP is in agreement with previous cross-sectional studies . These results suggest that runners who develop PFP use a different proximal neuromuscular control strategy than those who remain healthy . Injury prevention and treatment strategies should consider addressing these altered hip mechanics",
"STUDY DESIGN R and omized controlled trial . OBJECTIVES To examine the effectiveness of isolated hip abductor and external rotator strengthening on pain , health status , and hip strength in females with patellofemoral pain ( PFP ) . BACKGROUND Altered hip kinematics result ing from hip muscle weakness has been proposed as a contributing factor in the development of PFP . To date , no study has examined clinical outcomes associated with isolated hip muscle strengthening in those with PFP . METHODS Twenty-eight females with PFP were sequentially assigned to an exercise ( n = 14 ) or a no-exercise control group ( n = 14 ) . The exercise group completed bilateral hip abductor and external rotator strengthening 3 times per week for 8 weeks . Pain ( visual analog scale ) , health status ( WOMAC ) , and hip strength ( h and held dynamometer ) were assessed at baseline and postintervention . Pain and health status were also evaluated at 6 months postintervention in the exercise group . Two-factor mixed-model analyses of variance were used to determine the effects of the intervention on each outcome variable . RESULTS Significant group-by-time interactions were observed for each variable of interest . Post hoc testing revealed that pain , health status , and bilateral hip strength improved in the exercise group following the 8-week intervention but did not change in the control group . Improvements in pain and health status were sustained at 6-month follow-up in the exercise group . CONCLUSION A program of isolated hip abductor and external rotator strengthening was effective in improving pain and health status in females with PFP compared to a no-exercise control group . The incorporation of hip-strengthening exercises should be considered when design ing a rehabilitation program for females with PFP . LEVEL OF EVIDENCE Therapy , level 2b",
"Objectives : To study the effect of additional strengthening of hip abductor and lateral rotator muscles in a strengthening quadriceps exercise rehabilitation programme for patients with the patellofemoral pain syndrome . Design : R and omized controlled pilot trial . Setting : Clinical setting with home programme . Participants : Fourteen patients with patellofemoral pain syndrome . Intervention : The subjects were r and omly assigned to the intervention group ( strengthening of quadriceps plus strengthening of hip abductor and lateral rotator muscles ) or to the control group ( strengthening of quadriceps ) . Both groups participated in a six-week home exercise protocol . Main outcome measures : The perceived pain symptoms , isokinetic eccentric knee extensor , hip abductor and lateral rotator torques and the gluteus medius electromyographic activity were assessed before and after treatment . Parametric and non-parametric tests were used to compare the groups before and after treatment with α=0.05 . Results : Only the intervention group improved perceived pain symptoms during functional activities ( P=0.02—0.04 ) and also increased their gluteus medius electromyographic activity during isometric voluntary contraction ( P=0.03 ) . Eccentric knee extensors torque increased in both groups ( P=0.04 and P=0.02 ) . There was no statistically significant difference in the hip muscles torque in either group . Conclusion : Supplementation of strengthening of hip abductor and lateral rotator muscles in a strengthening quadriceps exercise programme provided additional benefits with respect to the perceived pain symptoms during functional activities in patients with patellofemoral pain syndrome after six weeks of treatment"
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We have conducted a systematic review of the scientific literature concerning outcome and clinical effectiveness of prostheses used for primary total hip replacement ( THR ) in Norway . The study is based on two Health Technology Assessment reports from the UK ( Faulkner et al. 1998 , Fitzpatrick et al. 1998 ) , review ing the literature from 1980 to 1995 . Using a similar search strategy , we have evaluated the literature from 1996 through 2000 . We included 129 scientific and medical publications which were assessed according to a specific appraisal protocol . The majority ( 72 % ) were observational studies , whereas only 9 % were r and omized studies . We could not retrieve any peer- review ed documentation for one third of the implants . The Charnley prosthesis had by far the best and most comprehensive evidence base with better than 90 % implant survival after about 10 years . Survival of the Charnley prosthesis declines by about 10 % during each of the two following decades . Except for the Charnley and Lubinus IP , no other prosthesis on the market in Norway has given long-term results ( > 15 years ) . 5 other cemented implants have given comparable results at about 10 years of follow-up . Some uncemented stems have shown promising medium-term outcome , but no combination of uncemented cup and stem fulfilled the benchmark criterion of > or = 90 % implant survival at 10 years , which we propose as a minimum requirement for unrestricted clinical use for prostheses used in primary THR . New or undocumented implants should be introduced through a four-step model including pre clinical testing , small series evaluated by radiosterometry , r and omized clinical trial involving comparison with a well-documented prosthesis , and finally , surveillance of clinical use through registers
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"Medium- and long-term results from cemented total hip arthroplasty ( THA ) in patients with rheumatoid arthritis ( RA ) show a higher incidence of infection and aseptic loosening when compared to other diagnoses . Early results using uncemented prostheses are variable . Hydroxyapatite ( HA ) coatings are thought to improve early osseointegration in uncemented THA . In a prospect i ve , international , multicenter clinical study , 32 RA patients who received 33 uncemented HA-coated prostheses were followed up for a minimum of 5 years . Medium-term clinical results are excellent . No infection or aseptic loosening has been recorded . Excellent osseointegration was observed radiographically . Bone remodeling was consistent with mainly proximal to midstem stress transfer . We conclude that uncemented , proximally HA-coated prostheses are a promising alternative to cemented prostheses for RA patients",
"We review ed the records of the long-term outcome of 208 Charnley and 982 Stanmore total hip replacements ( THR ) performed by or under the supervision of one surgeon from 1973 to 1987 . The Stanmore implant had a better survival rate before revision at 14 years ( 86 % to 79 % , p = 0.004 ) , but the difference only became apparent at ten years . The later Stanmore implants did better than the early ones ( 97 % to 92 % at ten years , p = 0.005 ) , the improvement coinciding with the introduction of a new cementing technique using a gun . Most of the Charnley implants were done before most of the Stanmore implants so that the difference between the results may in part be explained by improved methods , but this is not the complete explanation since a difference persisted for implants carried out during the same period of time . We conclude that improved techniques have reduced failure rates substantially . This improvement was much greater than that observed between these two design s of implant . Proof of the difference would require a very large r and omised controlled trial over a ten-year period",
"This article presents a prospect i ve clinical and radiologic review of 55 total hip replacements in 50 patients in which the cementless Harris-Galante porous-coated acetabular component was used . All patients were 50 years of age or younger . The cups were inserted by 15 different surgeons . The minimum followup was 5 years , with a mean of 7 years . No acetabular component has been revised for loosening , and none have migrated . Three ( 5.5 % ) cups have progressive bone-component radiolucent lines , two ( 3.6 % ) of which are complete . Six ( 10.9 % ) acetabular liners have been replaced for excessive polyethylene wear , and an additional four ( 7.3 % ) show sufficient wear to produce obvious radiographic eccentricity of the femoral head . All of the revised liners had 32-mm femoral heads and an initial polyethylene thickness of less than 6 mm . Although the results reflect excellent fixation of this component in the medium term , the incidence of exchange of the polyethylene liner for excessive wear is unacceptably high . The reduction in polyethylene thickness associated with the use of a metal-backed component and a 32-mm articulation was one of the factors contributing to the accelerated wear patterns seen in this series",
" A total of 410 hips were r and omized to treatment with either a Charnley ( 206 hips ) or a Spectron ( 204 hips ) total hip arthroplasty . The patients were operated on by a st and ardized procedure using a contemporary cementing technique and were followed after 1 , 3 , 5 to 6 , and 10 years . The postoperative radiographs showed a significantly increased rate of malalignment and consequently low grade of cement mantle quality of the Charnley stem compared to the Spectron . No differences concerning cement mantle quality or positioning were found between the Charnley ogee cup and the metal-backed Spectron . Evaluation of the follow-up radiographs revealed 10 loose Charnley stems and 1 loose Spectron stem and 4 loose Charnley ogee cups and 23 loose Spectron metal-backed cups . The differences of revision rate for the femoral and acetabular components of the 2 prostheses were significant ( P = .03 , Charnley femoral component more frequent ; P = .03 , Spectron acetabular component more frequent ) . The radiographic evaluation strengthened this disparity . Poor wear characteristics of the metal-backed Spectron cup are perhaps the main reason for the highly significant difference in mechanical failure rate between the 2 cups . We therefore propose that metal-backing of cemented cups should be avoided , at least when combined with larger femoral heads . The difficulty in positioning the Charnley stem with an adequate cement mantle , especially in the absence of trochanteric osteotomy , might explain the inferior Charnley stem longevity in this study",
" 155 patients ( 171 hips ) with a mean age of 50 years ( 24 - 64 ) were r and omized to uncemented PCA ( 84 hips ) or Harris-Galante type I ( 87 hips ) total hip arthroplasty . Clinical and radiographic evaluations were done regularly . The improvements in the Harris hip and pain scores did not differ . Osteolysis developed in 5 PCA and 17 Harris-Galante hips . 13 hips in the PCA and 16 in the Harris-Galante ( HG ) group were revised because of mechanical failures and 1 hip ( HG ) because of infection after a mean follow-up of 9 years . Decreased 10-year survival rate , based on revision as end-point , was noted for the PCA ( 85 % ) , compared with the Harris-Galante cup ( 99 % ) . The corresponding survival rate of the PCA stem ( 96 % ) was higher than that observed for the Harris-Galante design ( 86 % ) . When radiographic failures were included , the survival rates of the 4 different components dropped to between 73 % and 94 % . These findings indicate that further revisions will be necessary and continuous radiographic follow-up is indicated to enable revision before severe bone destruction has occurred . Although the PCA and the Harris-Galante design s differed as regards the survival of the individual components , the overall clinical and radiographic survival rates of these cementless total hip arthroplasties were poor",
" One hundred and twenty-nine consecutive cementless primary total hip arthroplasties with Zweymüller-Alloclassic grit-blasted titanium components were evaluated prospect ively at an average follow-up of 5.9 years . The clinical results were grade d as excellent or good in 116 hips ( 90 % ) , fair in 12 , and poor in one due to a fracture of the femoral shaft at operation leading to early stem loosening and delayed ring loosening . Failure was defined as definite aseptic loosening , and the final survivorship at 8 years was 99.3 % for the SL-stem , and 99.1 % for the CSF-threaded cup . These early results compare favourably with those of total hip arthroplasties using new cementing techniques",
"A r and omized , concurrently controlled , prospect i ve , single-blinded , multicenter study was done to evaluate the effect of proximal surface coating of a femoral prosthesis on clinical and radiographic results of cementless total hip arthroplasty ( THA ) . The Profile femoral prosthesis ( DePuy , Warsaw , IN ) , an anatomic titanium alloy stem , was used in one of three configurations : ( 1 ) smooth , ( 2 ) porous coated , or ( 3 ) hydroxyapatite ( HA ) coated . Ninety-one cases were enrolled in the study , with seven cases lost to follow-up and 79 cases available for clinical review with 24- to 48-month follow-up . The study shows that HA-coated stems performed as well , if not better than , porous-coated or smooth stems . Results show HA-costed stems with statistically superior total Harris hip scores ( microHA = 96.0 ) than smooth stems ( microS = 85.1 ) ( Student 's t-test , P = 0.004 ) . This was primarily due to differences between the functional score of the two groups ( microHA - 31.6 ; microS = 27.9 , P = 0.003 ) . Porous-coated stems were intermediate in performance ( microPC = 89.8 ) , with hip scores that were statistically indistinguishable from both smooth and HA-coated stems . Our data support the hypothesis that clinical differences exist and are attributable to the type of surface coating used for the cementless femoral components in THA",
" Between January 1988 and January 1991 we performed 100 consecutive cemented total hip replacements using a zirconia head , a titanium alloy stem and a polyethylene cup . We review ed 78 of these hips in 61 patients in detail at a mean of 5.8 years ( 1 to 9 ) . Aseptic loosening was seen in 11 hips ( 14 % ) . Eight needed revision . In total , 37 cups ( 47.5 % ) showed radiolucent lines , all at the cement-bone interface , with 18 ( 23 % ) involving all the interface . Of the 78 femoral implants , 17 ( 21.7 % ) showed radiolucent lines , and two , which had a complete line of more than 1 mm thick , definite endocortical osteolyses . There was also an abnormally high incidence of osteolysis of more than 2 mm at the calcar . Survivorship analysis showed that only 63 % were in situ at eight years . These worrying results led us to ab and on the use of zirconia heads , since at the same hospital , using the same femoral stem , cement and polyethylene cup , but with alumina femoral heads , the survival rate was 93 % at nine years . We discuss the possible reasons for the poor performance of zirconia ceramic",
"Seventy primary total hip arthroplasties using the Harris-Galante acetabular cup ( Zimmer , Warsaw , IN ) were prospect ively examined . Over the entire period of 65.4+/-7.8 months , radiologic migration analysis was performed using the Einbildroentgenanalyse ( EBRA ) method at an accuracy of 1 mm . Although there was clinical ly no suspicion of prosthetic loosening in any case , in 8 implants ( 11.4 % ) migration of more than 1 mm was observed . Cranial migration occurred in 3 cases ( 1.1 , 1.3 and 1.6 mm ) , medial migration in 3 cases ( 1.1 , 1.1 , and 2.9 mm ) , and lateral migration in 2 cases ( 1.1 and 1.1 mm ) . In the other 62 cases , however , no migration was traceable . Compared with measurements of other implant systems by means of the EBRA method published recently by other groups , the migration rate of the Harris-Galante cup was without exception lower and provided excellent midterm implant stability",
" One hundred and eighty-four patients who had been managed , between 1984 and 1985 , with a total of 204 consecutive primary total hip arthroplasties with insertion of a Harris-Galante type-I acetabular component without cement were prospect ively studied . There were eighty-two men ( 45 per cent ) and 102 women ( 55 per cent ) . The mean age at the time of the operation was fifty-two years ( range , twenty to eighty-four years ) . One hundred and fifty-seven patients ( 173 hips ) were available for clinical review at a mean of 104 months ( range , seventy-eight to 126 months ) . At this time , the mean preoperative Harris hip score of 52 points ( range , 12 to 79 points ) had improved to a mean of 90 points ( range , 44 to 100 points ) . Two patients ( two hips ) had had an exchange of an excessively worn polyethylene liner . One patient ( one hip ) had had débridement and grafting of an area of massive retroacetabular osteolysis . Two stable acetabular components ( 1 per cent ) had been revised at the time of femoral revision . None of the cups had been revised because of aseptic loosening . Radiographic examination of 150 patients ( 165 hips ) at a mean of 104 months ( range , seventy-eight to 126 months ) revealed that 156 cups ( 95 per cent ) were stable . Eight cups ( 5 per cent ) were considered to be possibly unstable , with a radiolucent line between the prosthesis and the bone that was one millimeter wide or less in at least four of five zones ; two of the eight had a complete radiolucent line in all zones . One component , which had been implanted with a bulk allograft from a femoral head , migrated more than two millimeters in the first two years and then stabilized without complication . Osteolysis was seen in seven acetabula ( 4 per cent ) and was limited to the periphery of the cup in six . Survivorship analysis at ten years revealed that the acetabular component had a 99 per cent chance of survival ( 95 per cent confidence interval , 0.98 to 1.0 ) with revision or aseptic loosening as the end point and a 97 per cent chance of survival ( 95 per cent confidence interval , 0.95 to 1.0 ) with revision , aseptic loosening , or reoperation because of a problem related to the acetabular component as the end point",
"A proximally hydroxyapatite (HA)-coated hip prosthesis design ed for proximal stem bonding and stress transfer was studied in a consecutive series of 398 patients in an ongoing , prospect i ve multicenter study . Follow-up was 5 to 7 years . The clinical results were excellent with a mean preoperative Merle d'Aubigné score of 8.5 and 17.3 at 5 years . Only mild thigh pain not necessitating analgesics or a walking stick was reported in 3.6 % at 5 years . Three cups and 3 stems had to be revised , all before the 2-year assessment and mainly for technical reasons . No components needed revision after 2 years . The 5-year HA-coated component survival was 99.2 % . Serial radiographs showed excellent osseointegration , which was independent of pre-existing bone stock . The rate of radiographic bone remodeling was highest during the first 3 years , and positive bone remodeling ( bone formation ) preceded negative bone remodeling ( bone resorption ) . The concept of transitional load transfer from proximal to distal could be acknowledged , with proximal load transfer highest in 77 % . The combination of anatomic stem design with distal overreaming and proximal HA coating was thought to be the reason for these excellent results . Proximal circumferential osseointegration seems to be real because no linear or distal osteolysis was observed",
"The Swedish National Total Hip Arthroplasty Register records primary hip replacements , revisions and surgical technique/environmental factors . The end-point for failure is revision . A prosthesis still in place , however , does not mean success . Clinical and radiographic outcomes should describe in more detail the efficacy of hip replacement surgery instead of the relatively blunt outcome measure that the register can provide . We performed a clinical outcome analysis on patients with primary total hip replacement thus testing the adequacy of the end-point for failure in the Swedish register . 1,113 r and omly selected patients who had had total hip replacement surgery between 1986 and 1995 answered a diseasespecific self-administered question naire ( WOMAC ) . A cohort of 344 patients was studied , using the Harris Hip Score and a conventional radiographic examination as outcome measures . We found clinical failure rates of 13 % and 20 % for all implants after 10 years , using 60 points or revision as the definition of failure in the Harris Hip Score and WOMAC , respectively . The result , according to the register during the same period , was a 7 % revision rate . The clinical failure rate depended on the type of evaluation tool , definition of failure and demographics , which made it difficult to decide whether there was a need for revision . With the exception of pain measured by the Harris Hip Score , the results showed no significant correlation between clinical failure and radiographic failure . Hence , with the knowledge that there is a difference between the revision rate according to the register and clinical outcome , the strict definition of failure in the register is useful as an end-point for primary hip replacement surgery",
"Two hundred three consecutive primary uncemented total hip arthroplasties were prospect ively r and omized using collared and collarless versions of an identical titanium stem . Identical 28-mm titanium heads were implanted in all cases . One hundred three collared hips were compared with 100 collarless hips . Follow-up periods averaged 45.7 months in both groups . Intraoperative , early , and late complications were similar . Hip scores , including thigh pain , at final follow-up visit were also similar . No significant differences were noted in acetabular or femoral radiolucencies , subsidence , osteolysis , or proximal femoral remodeling . At 5 years , more collarless stems revealed pedestal formation ( 57.1 % vs 33.9 % ) . The presence of a collar had no effect on the adequacy of fixation , proximal femoral osteopenia , or clinical scores at 5 years",
"One hundred and thirty-three patients ( 152 hips ) who were an average of thirty-nine years old ( range , sixteen to forty-nine years old ) received a proximally hydroxyapatite-coated femoral prosthesis as part of a total hip arthroplasty and were followed for a minimum of five years ( average , 6.4 years ; range , five to 8.3 years ) or until revision . The average Harris hip score was 47 points ( range , 22 to 77 points ) preoperatively and 93 points ( range , 49 to 100 points ) at the time of the latest clinical evaluation . Two patients who had a well fixed femoral implant had activity-limiting pain in the thigh at the time of the most recent examination . Radiographic changes consistent with bone-remodeling ( cortical hypertrophy and bone condensation ) typically were seen around the mid-part of the shaft of the prosthesis . Forty-eight ( 32 per cent ) of the 148 hips that were included in the radiographic analysis demonstrated a small amount of erosive scalloping in either zone 1 or zone 7 of Gruen et al. , and intramedullary osteolysis was suspected in only one hip . All stems were radiographically osseointegrated according to a modification of the criteria described by Engh et al. Four stems were revised , but none of the revisions were performed because of mechanical failure ( two stems were revised in conjunction with a revision of the cup because of pain ; one , because of an infection ; and one , after a traumatic femoral fracture that occurred six years postoperatively ) . Thus , the rates of aseptic and mechanical failure were both 0 per cent . The combined rate of failure , which included the two stems that were revised because of pain and the two stems that were associated with pain that limited activity , was 2.6 per cent ( four of 152 stems ) . The over-all clinical results associated with hydroxyapatite-coated femoral components were excellent in this group of young patients after intermediate-term follow-up . A review of serial radiographs showed mechanically stable implants with osseous ingrowth , evidence of stress transmission at the middle part of the stem , and minimum endosteal osteolysis",
" One hundred nineteen consecutive primary hybrid total hip arthroplasties with a precoated femoral component were performed by one surgeon in 100 patients and followed up prospect ively . Ninety-eight hips in 82 patients ( mean age , 67 years ) were evaluated clinical ly and radiographically at a mean of 6.5 years ( range , 5 - 9 years ) . The hips were evaluated clinical ly using the Harris hip score , and radiographs were evaluated for femoral cement grade , loosening , and osteolysis . Ninety-five hips remained in place at the most recent followup . Two femoral components were revised for definite loosening , and one well fixed femoral component was removed because of late hematogenous infection . Excluding the three hips that were revised , the clinical result was excellent or good in 79 hips ( 83 % ) , fair in 12 hips ( 13 % ) , and poor in four hips ( 4 % ) . All other femoral components were well fixed . There were defects of the cement mantles ( C1 and C2 ) in 90 hips . No femoral component had a stem and cement radiolucent line . Focal femoral osteolysis was seen in only two hips . One acetabular component was removed at 5 years because of late hematogenous infection . One acetabular component had asymptomatic migration . The remaining 96 acetabular components were well fixed . Focal acetabular osteolysis was present in four hips . The mean linear polyethylene wear rate was 0.06 ( + /- 0.05 ) mm per year . In contrast to other reports of early failure and osteolysis , the use of a precoated femoral component in this study did not adversely affect the fixation of hybrid total hip arthroplasty , with definite failure of only 2 % ( two of 98 ) of the femoral components",
"Prospect i ve , r and omized studies must be performed when new surgical techniques or implants are evaluated . In this study , a new implant system was compared with the Charnley prosthesis , which over the years has been the most used hip implant in Sweden . Between 1985 and 1989 , 410 hips were r and omized to treatment with a Charnley or a Spectron total hip arthroplasty : 206 Charnley and 204 Spectron prostheses were implanted . The patients were operated on by a st and ardized procedure using a contemporary cementing technique . The patients were followed prospect ively by an independent observer after 1 , 3 , 5 to 6 , and 10 years . Harris Hip Score and patient satisfaction were recorded in the outcome evaluation . A total of 144 patients with 164 hips were deceased , and 15 patients ( 8 Charnley and 7 Spectron ) have required a revision . Nine hips were revised because of aseptic loosening ( 5 Charnley stems and 4 Spectron metal-backed cups ) . The Charnley stem as well as the metal-backed Spectron cup had a higher risk for revision because of aseptic loosening . The Charnley ogee cup and the Spectron stem have performed remarkably well with no revision of these components . Seven Charnley prostheses dislocated , but no dislocation was recorded in the Spectron group . Survivorship calculations with a mean follow-up of 10 years revealed an overall 11-year survivorship of 94.5 % + /- 3.4 % ( Charnley , 93.2 % + /- 5.8 % ; Spectron , 95.9 % + /- 3.0 % ) . The clinical outcome did not differ between the 2 systems . The overall results in this old population , using a contemporary surgical technique , illustrate that cemented hip arthroplasty is an excellent treatment alternative for elderly patients",
" Between July 1986 and November 1989 , 437 consecutive primary cemented total hip arthroplasties were performed using a straight-stemmed titanium alloy femoral component . Collared and collarless versions of this identical stem were r and omly chosen by computer allowing a comparison between 213 collared stems ( 198 patients ) and 224 collarless stems ( 209 patients ) . Diagnosis , sex , weight , and average age ( 72.8 years , collared ; 72.0 years , collarless ) were similar . Follow-up averaged 76 months ( collared ) and 72 months ( collarless ) with 49 patients followed for at least 10 years . Calcar-collar contact was noted in 205 hips ( 96 % ) on the initial postoperative radiograph . Early complications , including dislocations ( 5 % each group ) , were similar . Late complications included 3 deep infections ( 2 collared , 1 collarless ) and 2 postoperative femur fractures ( 1 each ) . Hip scores at the most recent follow-up averaged 91.2 and 90.1 in the collared and collarless groups . No or slight pain was noted in 93 % of collared and 91.5 % of collarless hips . Although no radiographic differences were noted in distal cortical hypertrophy , stem subsidence , and osteolysis , collarless hips lost significantly more medial femoral neck cortical bone ( average 0.90 mm vs 0.63 mm ) . A higher incidence of radiolucent lines in femoral zone VI ( 20.7 % vs 9.4 % ) was also noted in collarless hips",
"We have compared prospect ively the incidence of loosening of 20 femoral stems with a matt surface with that of 20 polished stems of an otherwise identical tapered , non-modular design of Exeter hip replacement . The stems were inserted using the same technique at operation and radiographs showed no difference in the adequacy of the cement mantle or of fixation . All the patients were review ed regularly and none was lost to follow-up . After a minimum follow-up of nine years , four matt but no polished stems had been revised for aseptic loosening . Polished stems subsided slightly within the cement mantle early , but did not loosen",
"From 1982 to 1987 , we r and omised prospect ively 413 patients requiring primary total hip replacements to receive either a Stanmore or Charnley prosthesis . They were review ed by an independent observer in an attempt to correlate a number of factors including femoral head size with longevity . There were 213 Stanmore hips and 200 Charnley prostheses . At five to ten years ( mean 6.5 ) 76 patients had died and 16 arthroplasties had required revision . Seven were radiologically loose in asymptomatic patients . There was only one case of deep infection . We found no difference statistically in the clinical outcome or in the revision rate of 4 % in the two types of prosthesis . The revision rate was greater for trainees than for senior operating surgeons , and there were recognisable technical errors in seven of the nine Stanmore , and four of the seven Charnley replacements which required revision . Retrospective radiological analysis of a r and om subset of 51 Charnely and 57 Stanmore femoral components showed no difference in femoral subsidence , but in 14 patients who had had bilateral replacements with one femoral component of each type , there was greater early subsidence of the Stanmore prosthesis . Our results confirm that conventional cemented total hip replacements give acceptable results in a general teaching unit , and we found no evidence of any effect of the size of the femoral head on wear or loosening at five to ten years",
"Sixty-two patients ( 64 hips ) were provided with porous press-fit cups ( Trilogy ) , plasma-sprayed with a coating consisting of 70 % hydroxyapatite and 30 % tricalcium phosphate . The patients were r and omized to a cup with cluster holes for adjunctive screw fixation ( n = 30 ) or to a cup without holes ( n = 34 ) . Radiostereometry was used to study migration and wear . Up to 2 years median translations and rotations median annual proximal wear ( 0.11 and 0.12 mm ) was within the expected range despite the use of a ceramic coating , and it did not differ between the 2 design s. Radiolucent lines were frequently seen postoperatively but diminished during the follow-up without any sign of migration into the gaps . At 2 years , the median Harris scores were 99 points ( range , 51 - 100 points ) in the group with and 98 points ( range , 69 - 100 points ) in the group without screws . The results indicate that early fixation can be achieved for ceramic-coated press-fit cups without using additional screw fixation",
" Data on 240 primary Charnley total hip arthroplasties , performed in 211 patients from October 1968 to July 1974 , were recorded prospect ively . Fifty-two prostheses were implanted in forty-six patients who were thirty-four to fifty-five years old , and 188 prostheses were implanted in 165 patients who were more than fifty-five years old . The results for the younger patients were compared with those for the older patients . Twenty hips were revised over-all , and all five of the infections and four of the five fractures of the femoral stem that occurred in this group were in the older patients . However , the rate of aseptic loosening was similar for the two age-groups ( three of the hips in the younger patients and five in the older patients ) . The probability of revision after twenty years for the two groups , as determined with Kaplan-Meier analysis , was 11.7 per cent for the younger patients and 10.7 per cent for the older patients . There was no significant difference between the two groups with regard to either the number of revisions or the percentage of patients who had radiographic signs of loosening . The median Charnley hip scores during the course of the study were also similar for the two groups . We recommend that Charnley low-friction arthroplasty be used even in younger patients , as the long-term results were excellent and were comparable with those in the elderly age-group",
"At the authors ' hospital , 410 primary total hip replacements were performed on 372 patients between September 1 , 1985 , and May 31 , 1989 . All hips were assigned r and omly to receive a Charnley prosthesis with an ogee flanged cup or a Spectron prosthesis with a metal backed cup . Eleven-year survivor analysis , using revision as the end point definition of failure , revealed a survival rate of 93.2 % ± 5.8 % for the Charnley replacement and 95.9 % ± 3.0 % for the Spectron . If each component of the systems was analyzed ( concerning aseptic loosening ) , the ogee cup and the Spectron stem had 100 % survival . The survivorship for all 410 hips was 94.5 % ± 3.4 % . If the end point definition of failure was exp and ed to include patient dissatisfaction , the survival rate decreased to 86.3 % ± 4.9 % . These survival rates were compared with the rates obtained by the Swedish National Hip Registry . The national cohort included all patients in Sweden who were treated surgically with a Charnley ( 14,053 patients ) or Spectron ( metal backed cup ) prosthesis ( 726 patients ) between September 1 , 1985 , and May 31 , 1989 . Eleven-year survivor analysis revealed a national survival rate of 92.1 % ± 0.7 % for the Charnley replacement and 88.6 % ± 6.1 % for the Spectron . The analyses from the Swedish Registry are based on more than 160,000 primary operations and 11,500 revisions . Despite the enormous amount of data , there are drawbacks , and registries never can replace the prospect i ve , r and omized trial . One reason is the Swedish National Registry is unable to discriminate between the individual cup and stem components when analyzing the cause of revision , and no clinical or radiographic information is collected . A potential drawback for the r and omized trial is performance bias because surgeons from specialized centers might perform better than the general orthopaedic surgeon",
"We investigated a press-fit anatomically shaped hip stem made of carbon fiber-reinforced composite material in a prospect i ve clinical study . The intention of the design was that a surface of interlaced carbon fibers in the proximal part would achieve metaphyseal fixation . A total of 51 carbon stems were implanted in 48 patients ( 30 women and 22 men ) . Mean age at operation was 59 years . The patients were followed clinical ly , radiologically , and with computed tomography . At 6-year follow-up , aseptic loosening was observed in 47 hips ( 92 % ) . Forty stems were revised on average 30 months ( range , 9 - 58 months ) postoperatively . All revised carbon stems showed fibrous fixation without any bony on-growth . No osteolysis was seen . Histologically , no carbon wear or inflammatory reactions were observed . Only 4 cases had a good clinical result with bony fixation on computed tomography scan . The carbon fiber prosthesis without effective ingrowth or on-growth irregularities showed a high rate of early loosening",
" Two hundred and twenty-four total hip arthroplasties were performed in 201 patients with use of a femoral component with hydroxyapatite coating of the proximal portion of the stem . The mean duration of follow-up was seventy-one months ( range , fifty-eight to eighty-seven months ) . Of the 224 arthroplasties , 208 ( 93 per cent ; 190 patients ) yielded a good or excellent clinical result . Four patients ( 2 per cent ) reported mild-to-moderate activity-related pain in the thigh , and two ( 1 per cent ) had aseptic loosening . The radiographic findings of progressive new-bone formation ( cancellous condensation and cortical hypertrophy ) throughout the zones adjacent to the middle and distal portions of the stem were evidence of early , extensive proximal fixation of the implant , with distal stress transfer through the implant , which is stiffer than the surrounding bone . Remodeling of the femur began early , was predictable , and progressed throughout the follow-up period . Cortical hypertrophy about the middle and distal portions of the stem occurred predominantly in the mediolateral plane ( in 105 hips [ 47 per cent ] , compared with thirteen hips [ 6 per cent ] in the anteroposterior plane ) , and it was more common in patients who had had poorer bone quality preoperatively . Intramedullary osteolysis was present in one femur ( 0.4 per cent ) at five years ; the osteolytic area was less than five millimeters in its greatest dimension and had not progressed at the time of the six-year follow-up evaluation . This low rate of osteolysis suggests that a circumferential coating of hydroxyapatite may effectively minimize migration of wear debris along the femoral stem . The progressive remodeling of the femur about the middle and distal portions of the stem , as evidence d by cancellous condensation and cortical hypertrophy , has not , to our knowledge , been described previously to this magnitude in association with proximally coated ( porous or hydroxyapatite-coated ) femoral implants",
"The effects of matte finish and modularity on loosening of tapered stems using the same cementing technique were studied prospect ively . In 80 patients , 82 cemented Exeter primary stems were implanted at total hip revision by one surgeon using the same surgical and cementing technique throughout the series . The polished stems behaved differently than the matte surfaced stems behaved . Polished stems subsided in the cement mantle an average of 1 mm at 2 years after implantation , but without subsequent loosening of stems at as long as 12 years after implantation . Matte surfaced stems with metal central izers had a higher loosening rate , and loss of fixation at the prosthesis to cement interface was identified as an early sign of loosening of these stems . At a mean 6-year followup , there were no revisions nor was there radiographic evidence of loosening of the polished modular stems . It is concluded that matte finish results in increased loosening of tapered stems but the introduction of modularity did not",
"A prospect i ve review was performed on 22 osteoporotic patients ( rated from 1 to 3 on the Singh Index ) with hydroxyapatite-coated total hip replacements . These results were compared with a control group ( Singh Index 4 to 6 ) of 45 patients ( 48 hips ) with respect to clinical and radiographic data . Surgery was performed over a six-year period ( 1991 to 1996 ) and the time to follow-up evaluation averaged 5 years ( range : 2 to 7 years ) . All patients , in both groups , were over 65 years old with an average age of 71 and 73 years , respectively . The pre-operative diagnoses and Harris hip scores were also similar for both groups . Clinical evaluation was based on the Harris Hip score and radiographic evaluations using Engh 's criteria . There was no significant difference between the final average Harris hip score in the osteoporotic bone group , which was 87 points , and that for the control group , which was 91 points ( p > 0.05 ) . Radiographic evaluation demonstrated confirmed bone ingrowth in most patients in each group ; one patient in each group had suspected bone ingrowth . No stems were revised for aseptic loosening and no endosteal lysis was found . Progressive bone formation was seen around the femoral stem proximally . The acetabular components demonstrated no sign of mechanical loosening or osteolysis . Bone formation was found in most patients in zone I , and in a few patients also in zone III . On the basis of the results of this study , it is believed that osteoporotic bone as a factor by itself should not compromise the early results of hydroxyapatite total hip arthroplasty and should provide good results in the long term",
"The hypothesis of a possibly diminished bony ingrowth revealed by the development of radiolucency or a radiodense line with time around a cementless femoral stem subsequent to indomethacin administration for prevention of heterotopic ossification was investigated . Eighty prospect i ve patients with indomethacin prophylaxis were compared with 82 patients without indomethacin prophylaxis chosen retrospectively . The same cementless implant was used in all cases , and patients were observed clinical ly and radiologically for a minimum of 6 years . The mean postoperative Harris hip score at 6 years was 91 versus 88 points , respectively , and there were significantly more excellent results ( Harris hip score > 90 ) in the indomethacin group . None of the patients underwent revision surgery . Radiologic signs such as loss of bone density and radiodense lines were observed around the shoulder of the prosthesis in a similar percentage in both groups . Significant subsidence of the stem was observed in one instance in the indomethacin group and in three instances in the control group . The results of this study are a strong indication that indomethacin does not influence the development of radiolucency or other radiologic changes around a cementless stem after 6 years",
"Surgeons who perform arthroplasties have posed some critical questions about hydroxyapatite . Does hydroxyapatite coating enhance bone ingrowth or ongrowth ? Will hydroxyapatite lead to increased polyethylene wear or an increased incidence of osteolysis ? Will the hydroxyapatite coating disappear , and if so , what will be left to maintain implant fixation ? A multicenter study of 316 hips ( 282 patients ) with a proximally hydroxyapatite coated stem and either a hydroxyapatite or porous coated cup were followed up 8.1 years ( range , 5.6 - 9.9 years ) . The average patient age was 50 years ( range , 16 - 81 years ) , and 61 % of the patients were male . One ( 0.3 % ) stem , three ( 2.7 % ) porous coated cups , and 25 ( 11.9 % ) hydroxyapatite coated cups were revised for aseptic loosening . Disappointing results on the acetabular side indicate that substrate design is critical . There were no cases of intramedullary femoral osteolysis , and the incidence of acetabular and proximal femoral osteolysis and polyethylene wear was no greater than that seen with other cementless or cemented components . Based on these clinical results and a critical review of the literature , it is concluded that hydroxyapatite coated hip components do enhance ingrowth or ongrowth with no increased incidence of osteolysis for as many as 10 years . Concern about the disappearance of the hydroxyapatite coating with time seems moot in light of the above clinical findings",
"Background : Use of modern cementing techniques for fixation of femoral components in total hip arthroplasty has had excellent clinical and radiographic results in most patients . However , several authors have described early loosening of femoral components with roughened and precoated finishes . The purpose of this study was to examine the performance of the precoated Iowa stem , which has increased offset , and to compare the results with those of another cemented precoated femoral component with st and ard offset used at our institution . Methods : We carried out a prospect i ve analysis of 102 primary hybrid total hip arthroplasties ( a cementless acetabular component and a cemented femoral component ) performed with use of the Iowa femoral component in ninety-five patients at our institution . The Iowa stem was used in hips that required greater offset than is available with st and ard stems as determined by preoperative templating . The average age of the patients at the time of the index procedure was sixty-nine years . Sixteen patients ( seventeen hips ) died before the forty-eight-month minimum follow-up period had elapsed . Two patients were lost to follow-up , and radiographic follow-up was incomplete for one . The mean duration of clinical and radiographic follow-up of the remaining eighty-two hips in the seventy-six surviving patients was sixty-five months ( range , forty-eight to 104 months ) . Results : The average preoperative Harris hip score of 47 points ( range , 16 to 69 points ) improved to an average of 87 points ( range , 24 to 100 points ) at the time of the review . Two hips underwent femoral component revision . Four femoral stems were radiographically loose at an average of thirty-four months . Femoral osteolysis was seen in five hips ( 6 percent ) at an average of fifty-four months postoperatively . No acetabular component was revised because of aseptic loosening . According to Kaplan-Meier analysis , the seven-year survival rate , with an end point of femoral revision , osteolysis , or stem debonding , was 90.6 percent ( 95 percent confidence interval , 0.87 to 0.94 ) . Conclusions : The prevalence of revision , osteolysis , and loosening after total hip arthroplasty with the Iowa femoral component at our institution was higher than that seen in our series of Harris Precoat stems , which had a survival rate of 98.4 percent ( 95 percent confidence interval , 0.97 to 1.00 ) at ten years with the same end points . The design of the Iowa stem may make it difficult to achieve a good cement mantle , and , in combination with the geometry and increased offset of the stem , may compromise the long-term survival of this cemented femoral component",
"In a prospect i ve study of 410 cemented hip replacements in 372 patients with a mean age of 71 years , mortality after 8 years was 33 % . Mortality for patients with osteoarthrosis was lower than in an age matched control population , probably because of a preoperative selection of patients . An estimate of costs and adjusted quality of life has shown that total hip replacement has a good cost utility even in the elderly patient . The conclusion of this study is that the indications for hip replacement in the elderly patient can be exp and ed . Such patients should undergo surgery earlier in the course of their disease"
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Clinical practice guidelines identify lithium as a first line treatment for mood stabilization and reduction of suicidality in bipolar disorders ( BD ) ; however , most individuals show sub-optimal response . Identifying biomarkers for lithium response could enable personalization of treatment and refine criteria for stratification of BD cases into treatment-relevant subgroups . Existing systematic review s identify potential biomarkers of lithium response , but none directly address the conceptual issues that need to be addressed to enhance translation of research into precision prescribing of lithium . For example , although clinical syndrome subtyping of BD has not led to customized individual treatments , we emphasize the importance of assessing clinical response phenotypes in biomarker research . Also , we highlight the need to give greater consideration to the quality of prospect i ve longitudinal monitoring of illness activity and the differentiation of non-response from partial or non-adherence with medication . It is unlikely that there is a single biomarker for lithium response or tolerability , so this review argues that more research should be directed toward the exploration of biosignatures . Importantly , we emphasize that an integrative science approach may improve the likelihood of discovering the optimal combination of clinical factors and multimodal biomarkers ( e.g. , blood omics , neuroimaging , and actigraphy derived-markers ) . This strategy could uncover a valid lithium response phenotype and facilitate development of a composite prediction algorithm . Lastly , this narrative review discusses how these strategies could improve eligibility criteria for lithium treatment in BD , and highlights barriers to translation to clinical practice including the often-overlooked issue of the cost-effectiveness of introducing biomarker tests in psychiatry
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"OBJECTIVE The authors explored the relationship of adherence to treatment with mood stabilizers ( lithium , carbamazepine , and sodium valproate ) and plasma levels of these drugs to future psychiatric hospitalizations . METHOD They prospect ively followed 98 patients with mood disorders who were prescribed mood stabilizers . These patients participated in an initial interview and completed a question naire regarding their adherence to the medications . Data on their plasma levels of these drugs were taken from assays done in the 3 months before the interview . RESULTS Six of the 98 patients were not classified as to medication adherence or plasma levels . Twenty-nine ( 32 % ) of the remaining patients reported partial adherence to the medication regimen , and 33 ( 36 % ) had an index plasma level that was suboptimal . At 18 months , rates of admission to a psychiatric hospital were significantly higher in the 16 partially adherent patients with subtherapeutic plasma levels ( N=13 , 81 % ) than in the 46 adherent patients with therapeutic plasma levels ( N=4 , 9 % ) . However , hospital admission was also more likely in partially adherent patients with therapeutic plasma levels than in adherent patients with subtherapeutic plasma levels . CONCLUSIONS Adherence to medication regimens may be a proxy measure of other healthy behaviors",
"BACKGROUND Functional and morphologic abnormalities of the cingulate cortex have been reported in mood disorder patients . To examine the involvement of anatomic abnormalities of the cingulate in bipolar disorder , we measured the volumes of this structure in untreated and lithium-treated bipolar patients and healthy control subjects , using magnetic resonance imaging ( MRI ) . METHODS The volumes of gray matter at the right and left anterior and posterior cingulate cortices were measured in 11 bipolar patients not taking any psychotropic medications ( aged 38 + /- 11 years , 5 women ) , 16 bipolar patients treated with lithium monotherapy ( aged 33 + /- 11 years , 7 women ) , and 39 healthy control subjects ( aged 37 + /- 10 years , 14 women ) . Volumetric measurements were made with T1-weighted coronal MRI images , with 1.5-mm-thick slices , at 1.5 T , and were done blindly . RESULTS Using analysis of covariance with age and intracranial volume as covariates , we found that untreated bipolar patients had decreased left anterior cingulate volumes compared with healthy control subjects [ 2.4 + /-.3 cm3 and 2.9 + /-.6 cm3 , respectively ; F(1,58 ) = 6.4 , p = .042 ] and compared with lithium-treated patients [ 3.3 + /-.5 cm3 ; F(1,58 ) = 11.7 , p = .003 ] . The cingulate volumes in lithium-treated patients were not significantly different from those of healthy control subjects . CONCLUSIONS Our findings indicate that anatomic abnormalities in left anterior cingulate are present in bipolar patients . Furthermore , our results suggest that lithium treatment might influence cingulate volumes in bipolar patients , which could possibly reflect postulated neuroprotective effects of lithium ",
"UNLABELLED Remission rates for Major Depressive Disorder ( MDD ) are low and unpredictable for any given antidepressant . No biological or clinical marker has demonstrated sufficient ability to match individuals to efficacious treatment . Biosignatures developed from the systematic exploration of multiple biological markers , which optimize treatment selection for individuals ( moderators ) and provide early indication of ultimate treatment response ( mediators ) are needed . The rationale and design of a multi-site , placebo-controlled r and omized clinical trial of sertraline examining moderators and mediators of treatment response is described . The target sample is 300 participants with early onset ( ≤30 years ) recurrent MDD . Non-responders to an 8-week trial are switched double blind to either bupropion ( for sertraline non-responders ) or sertraline ( for placebo non-responders ) for an additional 8 weeks . Clinical moderators include anxious depression , early trauma , gender , melancholic and atypical depression , anger attacks , Axis II disorder , hypersomnia/fatigue , and chronicity of depression . Biological moderator and mediators include cerebral cortical thickness , task-based fMRI ( reward and emotion conflict ) , resting connectivity , diffusion tensor imaging ( DTI ) , arterial spin labeling ( ASL ) , electroencephalograpy ( EEG ) , cortical evoked potentials , and behavioral/cognitive tasks evaluated at baseline and week 1 , except DTI , assessed only at baseline . The study is design ed to st and ardize assessment of biomarkers across multiple sites as well as institute replicable quality control methods , and to use advanced data analytic methods to integrate these markers . A Differential Depression Treatment Response Index ( DTRI ) will be developed . The data , including biological sample s ( DNA , RNA , and plasma collected before and during treatment ) , will become available in a public scientific repository . CLINICAL TRIAL REGISTRATION Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression ( EMBARC ) . Identifier : NCT01407094 . URL : http:// clinical trials.gov/show/NCT01407094",
"Antidepressant medications are commonly used to treat depression , but only about 30 % of patients reach remission with any single first-step antidepressant . If the first-step treatment fails , response and remission rates at subsequent steps are even more limited . The literature on biomarkers for treatment response is largely based on secondary analyses of studies design ed to answer primary questions of efficacy , rather than on a planned systematic evaluation of biomarkers for treatment decision . The lack of evidence -based knowledge to guide treatment decisions for patients with depression has lead to the recognition that specially design ed studies with the primary objective being to discover biosignatures for optimizing treatment decisions are necessary . Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care ( EMBARC ) is one such discovery study . Stage 1 of EMBARC is a r and omized placebo controlled clinical trial of 8 week duration . A wide array of patient characteristics is collected at baseline , including assessment s of brain structure , function and connectivity along with electrophysiological , biological , behavioral and clinical features . This paper reports on the data analytic strategy for discovering biosignatures for treatment response based on Stage 1 of EMBARC",
"Background Lithium remains a first-line treatment in bipolar disorder , but individual response is variable . Previous studies have suggested that lithium response is a heritable trait . However , no genetic markers have been reproducibly identified . Methods Here we report the results of a genome-wide association study of lithium response in 2,563 patients collected by 22 participating sites from the International Consortium on Lithium Genetics ( ConLiGen ) ; the largest attempted so far . Data from over 6 million common single nucleotide polymorphisms ( SNPs ) were tested for association with categorical and continuous ratings of lithium response of known reliability . Findings A single locus of four linked SNPs on chromosome 21 met genome-wide significance criteria for association with lithium response ( rs79663003 : p=1·37 × 10−8 ; rs78015114 : p=1·31 × 10−8 ; rs74795342 : p=3·31 × 10−9 ; rs75222709 : p=3·50 × 10−9 ) . In an independent , prospect i ve study of 73 patients treated with lithium monotherapy for a period of up to two years , carriers of the response-associated alleles had a significantly lower rate of relapse than carriers of the alternate alleles ( p=0·03 , hazard ratio = 3·8 ) . Interpretation The response-associated region contains two genes coding for long non-coding RNAs ( lncRNAs ) , AL157359.3 and AL157359.4 . LncRNAs are increasingly appreciated as important regulators of gene expression , particularly in the CNS . Further studies are needed to establish the biological context of these findings and their potential clinical utility . Confirmed biomarkers of lithium response would constitute an important step forward in the clinical management of bipolar disorder",
"It is unclear which maintenance treatment for bipolar disorder is superior in clinical practice . R and omized controlled head-to-head trials of available drugs either do not exist or are inconclusive . We aim ed to compare rates of monotherapy treatment failure in individuals prescribed lithium , valproate , olanzapine or quetiapine by a population -based cohort study using electronic health records . 5,089 patients with bipolar disorder were prescribed lithium ( N=1,505 ) , valproate ( N=1,173 ) olanzapine ( N=1,366 ) or quetiapine ( N=1,075 ) as monotherapy . Treatment failure was defined as time to stopping medication or add-on of another mood stabilizer , antipsychotic , antidepressant or benzodiazepine . In unadjusted analyses , the duration of successful monotherapy was longest in individuals treated with lithium . Treatment failure had occurred in 75 % of those prescribed lithium by 2.05 years ( 95 % CI : 1.63 - 2.51 ) , compared to 0.76 years ( 95 % CI : 0.64 - 0.84 ) for those prescribed quetiapine , 0.98 years ( 95 % CI : 0.84 - 1.18 ) for those prescribed valproate , and 1.13 years for those prescribed olanzapine ( 95 % CI : 1.00 - 1.31 ) . Lithium 's superiority remained in a propensity score matched analysis ; when treatment failure was defined as stopping medication or add-on of a mood stabilizer or antipsychotic ; and when treatment failure was restricted to more than three months after commencing the study drug . Lithium appears to be more successful as monotherapy maintenance treatment than valproate , olanzapine or quetiapine . Lithium is often avoided because of its side effect profile , but alternative treatments may reduce the time to being prescribed more than one drug , with potential additive side effects of these treatments",
"Abstract Background Bipolar disorder is a serious and common psychiatric disorder characterized by manic and depressive mood switches and a relapsing and remitting course . The cornerstone of clinical management is stabilization and prophylaxis using mood-stabilizing medications to reduce both manic and depressive symptoms . Lithium remains the gold st and ard of treatment with the strongest data for both efficacy and suicide prevention . However , many patients do not respond to this medication , and clinical ly there is a great need for tools to aid the clinician in selecting the correct treatment . Large genome wide association studies ( GWAS ) investigating retrospectively the effect of lithium response are in the pipeline ; however , few large prospect i ve studies on genetic predictors to of lithium response have yet been conducted . The purpose of this project is to identify genes that are associated with lithium response in a large prospect i ve cohort of bipolar patients and to better underst and the mechanism of action of lithium and the variation in the genome that influences clinical response . Methods / Design This study is an 11-site prospect i ve non-r and omized open trial of lithium design ed to ascertain a cohort of 700 subjects with bipolar I disorder who experience protocol -defined relapse prevention as a result of treatment with lithium monotherapy . All patients will be diagnosed using the Diagnostic Interview for Genetic Studies ( DIGS ) and will then enter a 2-year follow-up period on lithium monotherapy if and when they exhibit a score of 1 ( normal , not ill ) , 2 ( minimally ill ) or 3 ( mildly ill ) on the Clinical Global Impressions of Severity Scale for Bipolar Disorder ( CGI-S-BP Overall Bipolar Illness ) for 4 of the 5 preceding weeks . Lithium will be titrated as clinical ly appropriate , not to exceed serum levels of 1.2 mEq/L. The sample will be evaluated longitudinally using a wide range of clinical scales , cognitive assessment s and laboratory tests . On relapse , patients will be discontinued or crossed-over to treatment with valproic acid ( VPA ) or treatment as usual ( TAU ) . Relapse is defined as a DSM-IV manic , major depressive or mixed episode or if the treating physician decides a change in medication is clinical ly necessary . The sample will be genotyped for GWAS . The outcome for lithium response will be analyzed as a time to event , where the event is defined as clinical relapse , using a Cox Proportional Hazards model . Positive single nucleotide polymorphisms ( SNPs ) from past genetic retrospective studies of lithium response , the Consortium on Lithium Genetics ( ConLiGen ) , will be tested in this prospect i ve study sample ; a meta- analysis of these sample s will then be performed . Finally , neurons will be derived from pluripotent stem cells from lithium responders and non-responders and tested in vivo for response to lithium by gene expression studies . SNPs in genes identified in these cellular studies will also be tested for association to response . Discussion Lithium is an extraordinarily important therapeutic drug in the clinical management of patients suffering from bipolar disorder . However , a significant proportion of patients , 30–40 % , fail to respond , and there is currently no method to identify the good lithium responders before initiation of treatment . Converging evidence suggests that genetic factors play a strong role in the variation of response to lithium , but only a few genes have been tested and the sample s have largely been retrospective or quite small . The current study will collect an entirely unique sample of 700 patients with bipolar disorder to be stabilized on lithium monotherapy and followed for up to 2 years . This study will produce useful information to improve the underst and ing of the mechanism of action of lithium and will add to the development of a method to predict individual response to lithium , thereby accelerating recovery and reducing suffering and cost . Trial registration Clinical Trials.govIdentifier : NCT01272531 Registered : January 6 ,",
" Ten patients with remitted bipolar illness on lithium maintenance therapy underwent placebo-controlled lithium discontinuation . Clinical ratings and recording of sleep-wake activity using wrist-worn actigraphs were carried out before and after lithium discontinuation . Seven patients experienced relapse into mania or hypomania within the first 3 months after lithium discontinuation . Actigraphic recordings revealed that patients who relapsed had higher baseline levels of daytime motor activity than patients without relapse . This may suggest that motor activity can be a sensitive marker of sub clinical manic tendencies and early relapse following lithium discontinuation",
"OBJECTIVES To assess the acceptability and feasibility of concordance therapy ( CCT ) in improving adherence with lithium prophylaxis in individuals with bipolar disorder . METHODS Ten subjects with bipolar I disorder and self-reported problems with lithium adherence were recruited . Eight participated in a 6-month study of CCT delivered by an expert in cognitive therapy . Reliable and valid assessment s of self-reported adherence with lithium , attitudes towards , and knowledge of lithium and serum plasma lithium levels were measured pre- and post-intervention . Subjects ' views of CCT were also recorded . RESULTS Statistically significant improvements in attitudes towards lithium ( mean score baseline = 6.8 ; follow up = 4.1 ; Effect size = 1.6 ) were associated with improvements in self-reported adherence . Laboratory results demonstrated statistically significant increases in serum plasma lithium levels ( mean increased from 0.41 to 0.6 ; effect size 1.7 ) . Subjects viewed CCT as an acceptable intervention . However , only four of the 10 subjects completed all seven half-hour therapy sessions and homework tasks . CONCLUSIONS This small open study suggests that CCT may represent a useful addition to the ' stepped care ' package of treatment for individuals with bipolar disorders . Research is underway to assess its efficacy and to establish whether novice therapists can also apply the model effectively"
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411738d6-06ff-11f0-808a-c43d1ab1c353
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Purpose There is considerable variation in incremental circulating 25-hydroxyvitamin D ( 25OHD ) levels on vitamin D supplements , even when similar age groups and identical vitamin D doses are compared . We therefore aim ed to investigate the importance of body weight for the dose – response relation in circulating 25OHD . Methods We performed a systematic review of r and omized placebo-controlled vitamin D supplementation trials in all age groups ≥10 years to clarify the influence of body weight and other parameters on incremental circulating 25OHD levels ( difference between baseline and in- study values ) in vitamin D-deficient and non-deficient individuals . Results We included 144 cohorts from 94 independent studies , published from 1990 to November 2012 , in our systematic review . There was a logarithmic association between vitamin D dose per kg body weight per day and increment in circulating 25OHD . In multivariable regression analysis , vitamin D dose per kg body weight per day could explain 34.5 % of variation in circulating 25OHD . Additional significant predictors were type of supplement ( vitamin D2 or vitamin D3 ) , age , concomitant intake of calcium supplements and baseline 25OHD , explaining 9.8 , 3.7 , 2.4 and 1.9 % , respectively , of the variation in circulating 25OHD . Conclusions This systematic review demonstrates that body weight is an important predictor of variation in circulating 25OHD in cohorts on vitamin D supplements . Our model provides an estimate of the daily vitamin D dose that is necessary for achieving adequate circulating 25OHD levels in vitamin D-insufficient or vitamin D-deficient individuals/cohorts with different body weights and ages
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"Objective : Assessment of the effectiveness and safety of high daily 125 μg ( 5000 IU ) or 250 μg ( 10 000IU ) doses of vitamin D2 during 3 months , in rapidly obtaining adequate 25 hydroxyvitamin D ( 25OHD ) levels . Design : Longitudinal study .Subjects : Postmenopausal osteopenic/osteoporotic women ( n=38 ) were studied during winter and spring . Median age ( 25–75th percentile ) was 61.5 ( 57.00–66.25 ) years , and mean bone mineral density ( BMD ) was 0.902 (0.800–1.042)g/cm2 . Subjects were r and omly divided into three groups : control group ( n=13 ) : no vitamin D2 , 125 μg/day ( n=13 ) and 250 μg/day ( n=12 ) of vitamin D2 groups , all receiving 500 mg calcium/day . Serum calcium , phosphate , bone alkaline phosphatase ( BAP ) , C-telopeptide ( CTX ) , 25OHD , mid-molecule parathyroid hormone ( mmPTH ) , daily urinary calcium and creatinine excretion were determined at baseline and monthly . Results : For all subjects ( n=38 ) , the median baseline 25 hydroxyvitamin D ( 25OHD ) level was 36.25 ( 27.5–48.12 ) nmol/l . After 3 months , 8 % of the patients in the control group , 50 % in the 125 μg/day group and 75 % in the 250 μg/day group had 25OHD values above 85 nmol/l ( 34 ng/ml ) . Considering both vitamin D2 groups together , mmPTH and BAP levels diminished significantly after 3 months ( P CTX . Serum calcium remained within normal range during the follow-up . Conclusions : The oral dose of vitamin D2 required to rapidly achieve adequate levels of 25OHD is seemingly much higher than the usual recommended vitamin D3 dose ( 20 μg/day ) . During 3 months , 250 μg/day of vitamin D2 most effectively raised 25OHD levels to 85 nmol/l in 75 % of the postmenopausal osteopenic/osteoporotic women treated",
"BACKGROUND The cholecalciferol inputs required to achieve or maintain any given serum 25-hydroxycholecalciferol concentration are not known , particularly within ranges comparable to the probable physiologic supply of the vitamin . OBJECTIVES The objectives were to establish the quantitative relation between steady state cholecalciferol input and the result ing serum 25-hydroxycholecalciferol concentration and to estimate the proportion of the daily requirement during winter that is met by cholecalciferol reserves in body tissue stores . DESIGN Cholecalciferol was administered daily in controlled oral doses labeled at 0 , 25 , 125 , and 250 micro g cholecalciferol for approximately 20 wk during the winter to 67 men living in Omaha ( 41.2 degrees N latitude ) . The time course of serum 25-hydroxycholecalciferol concentration was measured at intervals over the course of treatment . RESULTS From a mean baseline value of 70.3 nmol/L , equilibrium concentrations of serum 25-hydroxycholecalciferol changed during the winter months in direct proportion to the dose , with a slope of approximately 0.70 nmol/L for each additional 1 micro g cholecalciferol input . The calculated oral input required to sustain the serum 25-hydroxycholecalciferol concentration present before the study ( ie , in the autumn ) was 12.5 micro g ( 500 IU)/d , whereas the total amount from all sources ( supplement , food , tissue stores ) needed to sustain the starting 25-hydroxycholecalciferol concentration was estimated at approximately 96 micro g ( approximately 3800 IU)/d . By difference , the tissue stores provided approximately 78 - 82 micro g/d . CONCLUSIONS Healthy men seem to use 3000 - 5000 IU cholecalciferol/d , apparently meeting > 80 % of their winter cholecalciferol need with cutaneously synthesized accumulations from solar sources during the preceding summer months . Current recommended vitamin D inputs are inadequate to maintain serum 25-hydroxycholecalciferol concentration in the absence of substantial cutaneous production of vitamin",
"AIMS A significant proportion of cardiac surgical patients develop critical post-operative complications . We aim ed to investigate the association of pre-operative 25-hydroxyvitamin D ( 25(OH)D ) levels with major cardiac and cerebrovascular events ( MACCE ) in cardiac surgical patients . METHODS AND RESULTS From January 2010 to August 2011 , we consecutively measured circulating 25(OH)D in 4418 operated patients . Of the study cohort , 38.0 % had deficient 25(OH)D values ( 100 nmol/L. The incidence of MACCE was 11.5 % . In multivariable-adjusted logistic regression models , the odds ratio of MACCE at deficient , inadequate , and high 25(OH)D levels was 2.23 [ 95 % confidence interval ( CI ) : 1.31 - 3.79 ] , 1.73 ( 95 % CI : 1.01 - 2.96 ) and 2.34 ( 95 % CI : 1.12 - 4.89 ) , respectively , compared with 25(OH)D levels of 75 - 100 nmol/L. A U-shaped association with circulating 25(OH)D was also present for duration of mechanical ventilatory support and intensive care unit stay . Multivariable-adjusted 6- and 12-month mortality were higher in patients with deficient 25(OH)D levels compared with patients with 25(OH)D levels of 75 - 100 nmol/L. CONCLUSION Deficient 25(OH)D levels are prevalent in cardiac surgical patients in Central Europe and are independently associated with the risk of MACCE . Further research should clarify the potential of vitamin D supplements in reducing cardiovascular risk in vitamin D-deficient patients and also the mechanisms leading to adverse effects on the cardiovascular system in the small group of patients with 25(OH)D levels > 100",
"OBJECTIVES To determine the effect of four vitamin D supplement doses on falls risk in elderly nursing home residents . DESIGN Secondary data analysis of a previously conducted r and omized clinical trial . SETTING Seven hundred twenty-five-bed long-term care facility . PARTICIPANTS One hundred twenty-four nursing home residents ( average age 89 ) . INTERVENTION Participants were r and omly assigned to receive one of four vitamin D supplement doses ( 200 IU , 400 IU , 600 IU , or 800 IU ) or placebo daily for 5 months . MEASUREMENTS Number of fallers and number of falls assessed using facility incident tracking data base . RESULTS Over the 5-month study period , the proportion of participants with falls was 44 % in the placebo group ( 11/25 ) , 58 % ( 15/26 ) in the 200 IU group , 60 % ( 15/25 ) in the 400 IU group , 60 % ( 15/25 ) in the 600 IU group , and 20 % ( 5/23 ) in the 800 IU group . Participants in the 800 IU group had a 72 % lower adjusted-incidence rate ratio of falls than those taking placebo over the 5 months ( rate ratio=0.28 ; 95 % confidence interval=0.11 - 0.75 ) . No significant differences were observed for the adjusted fall rates compared to placebo in any of the other supplement groups . CONCLUSION Nursing home residents in the highest vitamin D group ( 800 IU ) had a lower number of fallers and a lower incidence rate of falls over 5 months than those taking lower doses . Adequate vitamin D supplementation in elderly nursing home residents could reduce the number of falls experienced by this high falls risk group",
"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",
"We investigated the short-term effects on bone turnover markers of high doses of vitamin D3 in order to identify what initial therapeutic dose can be safely administered in vitamin D-deficient subjects . Thirty-seven elderly subjects [ mean age 75 ± 3 ( SD ) years ] were consecutively r and omized to the administration of a single oral bolus of 600000 , 300000 , or 100000 IU vitamin D3 . Blood sample s were taken at baseline and 1 , 3 , 7 , 14 , 30 , 60 , and 90 days after vitamin D3 administration . Twenty-four subjects served as controls . No relevant changes in bone turnover markers [ C-terminal telopeptides of type I collagen ( sCTX ) and bone-specific alkaline phosphatase ( BAP ) ] were observed in the controls . In treated patients a dose-dependent effect on sCTX was observed . With the administration of 600,000 IU vitamin D3 a significant increase of sCTX was observed already at day 1 , and it was sustained for 2 months . The changes in sCTX with smaller doses were considerably lower and reached statistical significance only within the first 3 days with the 300,000 IU dose . BAP remained unchanged in patients given 300,000 and 600,000 IU vitamin D3 , while it significantly rose by 15–23 % throughout the observation period in patients given 100,000 IU . Our results indicate that the use of a vitamin D bolus exceeding 100,000 IU may be associated with acute increases of sCTX ",
"Objective : To investigate the interrelationship between cardiac surgery , age , circulating concentrations of the vitamin D hormone 1,25-dihydroxyvitamin D , and clinical outcome . Design : Prospect i ve , monocentric , two-arm parallel study . Setting : Tertiary Heart and Diabetes Center in the Federal State of North Rhine-Westphalia , Germany . Patients : Twenty-nine cardiac surgical patients aged ⩽65 yrs and 30 patients ≥75 yrs . Measurements : We assessed 1,25-dihydroxyvitamin D and other biochemical parameters of mineral metabolism ( calcium , phosphate , 25-hydroxyvitamin D , and parathyroid hormone ) , various inflammatory markers ( C-reactive protein , interleukin-6 and 8) , and different immunological parameters ( CD4 and CD8 cells , monocyte HLA-DR expression ) . We collected blood sample s preoperatively , immediately after surgery , and on postoperative days 1 , 5 , and 30 . In addition , we assessed adverse outcome until discharge as a composite of myocardial infa rct ion , low cardiac output syndrome , infection , stroke , or in-hospital death . Results : There were significant transient cardiac surgery-related fluctuations in 1,25-dihydroxyvitamin D and the aforementioned parameters of mineral metabolism , inflammation , and immune status . Compared to younger patients , older patients had consistently lower 1,25-dihydroxyvitamin D and phosphate levels ( p = .013 and p = .036 , respectively ) and significantly higher interleukin 6 and 8 levels ( p = .008 and p . Circulating 1,25-dihydroxyvitamin D was directly related to glomerular filtration rate ( R2 = .227 ; p to interleukin 6 ( R2 = .105 ; p = .012 ) . The rate of adverse outcome tended to be higher in older than in younger patients ( 20.0 % vs. 3.5 % ; p = .081 ) . In risk score-adjusted logistic regression analysis , adverse outcome risk decreased by 7.7 % ( SE : 3.7 % ) for each pmol/L increment in 1,25-dihydroxyvitamin D ( p = .037 ) . Conclusions : Circulating 1,25-dihydroxyvitamin D levels fluctuate in relation to cardiac surgery . Low 1,25-dihydroxyvitamin D levels are associated with inflammatory processes and age-related differences in clinical outcome . Future studies should determine whether therapies aim ed at treating low 1,25-dihydroxyvitamin D levels can improve the outcome in older cardiac surgery patients",
"Few foods contain ergocalciferol or cholecalciferol . Treatment of mushrooms with UV light increases ergocalciferol content and could provide a dietary source of vitamin D. We evaluated the impact of consuming UV-treated white button mushrooms ( Agaricus bisporus ) on the vitamin D status of healthy adults . Thirty-eight volunteers were r and omized to 4 treatments consumed with a st and ard meal for 6 wk : the control ( C ) group received untreated mushrooms providing 0.85 μg/d ergocalciferol ( n = 10 ) ; groups M1 and M2 received UV-treated mushrooms providing 8.8 ( n = 10 ) and 17.1 μg/d ( n = 9 ) , respectively ; and the supplement ( S ) group received purified ergocalciferol plus untreated mushrooms , providing a total of 28.2 μg/d ( n = 9 ) . Serum total 25-hydroxyvitamin D [ 25(OH)D ] and 25-hydroxyergocalciferol [ 25(OH)D2 ] were 83 ± 38 and 2.4 ± 2.0 nmol/L , respectively , at baseline ( mean ± SD ) . At wk 6 , 25(OH)D2 had increased and was higher in all treatment groups than in the C group , whereas 25-hydroxycholecalciferol [ 25(OH)D3 ] had decreased and was lower in the M2 and S groups than in the C group . Increases in 25(OH)D2 for groups C , M1 , M2 , and S were 1.2 ± 5.2 , 13.8 ± 7.3 , 12.7 ± 3.7 , and 32.8 ± 3.3 nmol/L and decreases in 25(OH)D3 were -3.9 ± 16.3 , -10.4 ± 6.4 , -20.6 ± 14.6 , and -29.5 ± 15.9 nmol/L , respectively . Concentrations did not change in group C. In summary , ergocalciferol was absorbed and metabolized to 25(OH)D2 but did not affect vitamin D status , because 25(OH)D3 decreased proportionally",
"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"
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ESTRO , the European Society for Therapeutic Radiation Oncology , or with its new name European Society for Radiation Oncology , is a scientific society . It means that the prime aim of ESTRO is to bring to bring people together on an individual basis who have a common interest in improving the scientific conduct of radiotherapy and cancer treatment in Europe by ensuring that proper radiotherapy is available in the multidisciplinary treatment of cancer and applied with the right indication and with the most optimal technique . One of the main aims of this endeavour was to create a platform for scientific exchange through meetings and through the establishment of a scientific journal [ 1 ] . Thus Radiotherapy and Oncology was launched shortly after the foundation of ESTRO and has become the society ’s prime vehicle for scientific communication by serving ESTRO members through almost the entire 30 years of the society ’s existence . The aim was to create a peer review ed high quality international journal and that aim has indeed been fulfilled . ‘ ‘ The green journal ’ ’ is today , together with ‘ ‘ the red journal ’ ’ , the prime international platform for scientific communication within radiotherapy . Both journals are anchored in large scientific societies and serve basically the same medical , physical and biological community and at the same scientific level ; the two journals are in the most recent Impact Factor list ranked almost back to back , indicating an equal importance and contribution to science . Radiotherapy and Oncology is more than a scientific journal , it also serves other purpose s such as facilitate education through ( educational ) review s and improving the st and ard of care by bringing forward guidelines for conduct of radiotherapy . Finally , the journal also tries to maintain a communication platform between the science produced by the membership of ESTRO and therefore it brings papers frommembers in the different European countries , sometimes at the expense of ultimate scientific quality , but with the underst and ing that it is important that the entire ESTRO membership gets access and opportunity to publish in a high ranked journal . Knowing that the weakest link is the most important to strengthen , the Journal has increasingly focussed on publishing guidelines , often produced by ESTRO committees or European consensus panels together with meta-analyses and review s. The focus on systematic review s is thus another example of the wish to bring forward evidence based refinement
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"EORTC protocol 22791 compared once daily fractionation ( CF ) of 70 Gy in 35 - 40 fractions in 7 - 8 weeks , to pure hyperfractionation ( HF ) of 80.5 Gy in 70 fractions in 7 weeks using 2 fractions of 1.15 Gy per day , in T2-T3 oropharyngeal carcinoma ( excluding base of tongue ) , N0,N1 of less than 3 cm . From 1980 to 1987 , 356 patients were entered . In the final analysis ( June 1990 ) , the local control was significantly higher ( p = 0.02 log-rank ) after HF compared with CF . At 5 years , 59 % of patients are local disease-free in the HF arm compared to 40 % in the CF arm . The superiority of HF was demonstrated in patients staged T3N0,T3N1 but not in T2 . The Cox model confirmed that the treatment regimen was an independent significant prognostic factor for locoregional control ( p = 0.007 log-rank ) . This improvement of locoregional control was responsible for a trend to an improved survival ( p = 0.08 log-rank ) . There was no difference in late normal tissue damage between the two treatment modalities",
"A r and omized trial was conducted at the Institut Gustave-Roussy ( IGR ) between 1972 and 1980 comparing tumorectomy and breast irradiation with modified radical mastectomy . One hundred and seventy-nine patients with an infiltrating breast carcinoma up to 20 mm in diameter at macroscopic examination were included : 88 had conservative management , and 91 a mastectomy . All patients had a low-axillary dissection with immediate histological examination . For the patients with positive axillary nodes , a complete axillary dissection was undertaken . Overall survival , distant metastasis , contralateral breast cancer and locoregional recurrence rates were not significantly different between the two treatment groups",
"Experimental evidence suggests that the hypoxic fraction in a solid tumor may increase its malignant potential and reduce its sensitivity towards non-surgical treatment modalities ( e.g. st and ard irradiation , certain anticancer agents ) . However , the clinical importance of tumor hypoxia remains uncertain since valid methods for the routine measurement of intratumoral O2-tensions in patients have so far been lacking . A clinical ly applicable st and ardized procedure has been established which enables the determination of intratumoral oxygen tensions in advanced cervical cancers by use of a computerized polarographic needle electrode histography system . Tumor oxygenation as measured by this method represents a novel tumor feature which can be individually determined for each tumor and which is independent from other known oncological parameters . The results of an interim analysis of an open prospect i ve clinical trial to evaluate the prognostic significance of tumor oxygenation based on the survival data of the first 31 patients are presented . Fifteen patients have been treated by primary radiation , 11 patients received multimodality therapy including irradiation . After a median follow-up of 19 months ( range 5 - 31 months ) , Kaplan-Meier-life table analysis showed significantly lower survival and recurrence-free survival for patients with a median pO2 of 10 mmHg ) . The Cox proportional hazards model revealed that the median pO2 and the clinical stage according to the FIGO are independent , highly significant predictors of survival and recurrence-free survival . We conclude from these preliminary results that tumor oxygenation as determined with this st and ardized procedure appears to be a new independent prognostic factor influencing survival in advanced cancer of the uterine cervix",
"Factors influencing time to loco-regional recurrence were identified in a multivariate regression analysis of data from a series of 468 radically operated patients ( 260 Dukes ' B and 208 Dukes ' C ) with carcinoma of the rectum and the rectosigmoid . A number of clinical and pathological characteristics were prospect ively collected and recorded . In addition , carcinoembryonic antigen ( CEA ) was measured within 1 week before surgery . The endpoint used was recurrence below the level of the umbilicus . All patients were followed for at least 5 years or until time of death . The two Dukes ' stages B and C were analysed in two separate analyses using the Cox proportional hazards model . In patients with Dukes ' B tumours , an increased risk of loco-regional recurrence was associated with perineural invasion , tumour located less than 10 cm from the anal verge , patient aged above 70 years , and small tumour size . In patients with Dukes ' C tumours , the necessity to resect neighbour organs , perineural and venous invasion , tumour located less than 10 cm from the anal verge , and large tumour size were all associated with a poor loco-regional outcome . Postoperative radiotherapy was not a significant prognosticator for loco-regional control . An up date of the 5-year results of the r and omised study of post-operative radiotherapy ( 50 Gy with 2 Gy per fraction in an overall treatment time of 7 weeks ) showed no survival benefit from adjuvant radiotherapy in either Dukes ' category and no statistically significant improvement in the 5-year loco-regional control rate . However , when the comparison was restricted to a group of high-risk patients there was a statistically significant benefit from radiotherapy with respect to loco-regional control ( P = 0.03 ) but not with respect to survival ( P = 0.23 ) . The potential advantage , in terms of the required number of patients , of restricting clinical trials of intensified loco-regional therapies to the high-risk patients , is illustrated",
"PURPOSE This study describes the acute response of oral and pharyngeal mucosa to chemo-IMRT schedules using different doses per fraction . MATERIAL S AND METHODS Patients , treated in prospect i ve trials of concomitant chemo-IMRT with 2.17 Gy , 2.25 Gy and 2.4 Gy per fraction and identical dose of cisplatin , were included in this study . Acute toxicity was recorded prospect ively using the CTCAE v2.0 . We describe the incidence and prevalence of grade 3 oral mucositis and dysphagia over time and report the influence of overall treatment time ( OTT ) . The association between the lengths of pharyngeal mucosa receiving 50 Gy ( L50 ) and 60 Gy ( L60 ) and grade 3 dysphagia was tested . RESULTS The incidence and the peak prevalence of grade 3 dysphagia were significantly higher in patients receiving 2.4 Gy per fraction . The peak prevalence of grade 3 dysphagia was higher and the recovery was slower in patients with lower OTT ( median 38 days vs. 42 days ) treatment . There was a significant correlation between L50 , L60 and grade 3 dysphagia . A L50 and L60 greater than 8 cm result ed in greater than 60 % and 70 % incidence of grade 3 dysphagia , respectively . CONCLUSION The length of pharyngeal mucosa receiving doses close to the prescription dose correlates with grade 3 dysphagia . It was observed that incidence of grade 3 dysphagia was lower and recovery from it was quicker in patients with greater OTT",
"BACKGROUND AND AIM Numerous consensus reports recommend that postmastectomy radiotherapy ( RT ) in addition to systemic therapy is indicated in high-risk patients with 4 + positive nodes , but not in patients with 1 - 3 positive nodes . A subgroup analysis of the DBCG 82 b&c trials was performed to evaluate the loco-regional recurrence rate and survival in relation to number of positive nodes . MATERIAL S AND METHODS In the DBCG 82 b&c trials 3083 pre- and postmenopausal high-risk women were r and omized to postoperative RT in addition to adjuvant systemic therapy . Since many patients had relatively few lymph nodes removed ( median 7 ) , the present analysis was limited to 1152 node positive patients with 8 or more nodes removed . RESULTS The overall 15-year survival rate in the subgroup was 39 % and 29 % ( p=0.015 ) after RT and no RT , respectively . RT reduced the 15-year loco-regional failure rate from 51 % to 10 % ( p 15-year survival benefit after RT was significantly improved in both patients with 1 - 3 positive nodes ( 57 % vs 48 % , p=0.03 ) and in patients with 4 + positive nodes ( 21 % vs 12 % , p=0.03 ) . CONCLUSION The survival benefit after postmastectomy RT was substantial and similar in patients with 1 - 3 and 4 + positive lymph nodes . Furthermore , it was not strictly associated with the risk of loco-regional recurrence , which was most pronounced in patients with 4 + positive nodes . The indication for RT seems therefore to be at least equally beneficial in patients with 1 - 3 positive nodes , and future consensus should be modified accordingly",
"BACKGROUND AND PURPOSE During the first decade of the 21st century a number of important European r and omized studies were published . In order to help shape clinical practice based on best scientific evidence from the literature , the International Conference on ' Multidisciplinary Rectal Cancer Treatment : Looking for an European Consensus ' ( EURECA-CC2 ) was organized in Italy under the endorsement of European Society of Medical Oncology ( ESMO ) , European Society of Surgical Oncology ( ESSO ) , and European Society of Therapeutic Radiation Oncology ( ESTRO ) . METHODS Consensus was achieved using the Delphi method . The document was available to all Committee members as a web-based document customized for the consensus process . Eight chapters were identified : epidemiology , diagnostics , pathology , surgery , radiotherapy and chemotherapy , treatment toxicity and quality of life , follow-up , and research questions . Each chapter was subdivided by a topic , and a series of statements were developed . Each member commented and voted , sentence by sentence thrice . Sentences upon which an agreement was not reached after voting round # 2 were openly debated during a Consensus Conference in Perugia ( Italy ) from 11 December to 13 December 2008 . A h and -held televoting system collected the opinions of both the Committee members and the audience after each debate . The Executive Committee scored percentage consensus based on three categories : \" large consensus \" , \" moderate consensus \" , and \" minimum consensus \" . RESULTS The total number of the voted sentences was 207 . Of the 207 , 86 % achieved large consensus , 13 % achieved moderate consensus , and only 3 ( 1 % ) result ed in minimum consensus . No statement was disagreed by more than 50 % of the members . All chapters were voted on by at least 75 % of the members , and the majority was voted on by > 85 % . CONCLUSIONS This Consensus Conference represents an expertise opinion process that may help shape future programs , investigational protocol s , and guidelines for staging and treatment of rectal cancer throughout Europe",
"PURPOSE To test for association between single nucleotide polymorphisms at the TGFβ1 locus and the risk of late normal tissue injury following whole breast radiotherapy . METHODS A retrospective study compared the number of variant alleles at -509 and codons 10 and 25 of the TGFβ1 locus in women followed up in two prospect i ve clinical trials who developed either marked radiotherapy adverse effects or no adverse effects after matching on fractionation schedule , breast size , surgical deficit , chemotherapy and length of follow up . RESULTS Median follow up in the two trials was 7.4 ( maximum 15 ) years and 5.3 ( maximum 5.3 ) years . 1237/1716 ( 72 % ) women with photographic assessment s of radiotherapy adverse effects were alive and well , and 147/1237 ( 12 % ) potential cases with the most marked change in photographic change in breast appearance were matched to potential controls recording no change . In an unmatched analysis of 82 cases and 108 controls , no significant difference in the number of genetic variants was observed . CONCLUSIONS No association was detected between sequence variations at the TGFβ1 locus and the risk of late adverse effects of breast radiotherapy",
"BACKGROUND AND PURPOSE The \" Registry for the evaluation of side effects after radiation in childhood and adolescence \" ( risk ) was introduced to characterize adverse effects of radiotherapy in childhood and adolescence prospect ively . The aim of this analysis was to characterize the pattern of acute side effects . MATERIAL S AND METHODS Since 2001 , patients receiving radiotherapy in one of the German pediatric therapy trials have been registered in RiSK with detailed information regarding radiation doses to organs at risk and characterization of acute toxicities . RESULTS From 2001 to May 2009 , 690 patients have been characterized for acute toxicity in primary therapy . Acute toxicity ≥ grade 1 was observed in 506 patients . In patients irradiated in their lung and liver , patients with grade 1 or 2 acute toxicities showed higher organ volumes exposed to radiation doses the acute toxicity grade and the maximum radiation dose to the organ ; the lower GI tract showed a similar trend . The impact of different chemotherapy regimens on these acute side effects remains unclear . Age did not have any impact on side effects . CONCLUSION This analysis gives a comprehensive overview of the acute toxicities of radiotherapy in children and adolescents . With prolongation of follow-up , detailed analyses regarding late toxicities will be possible with the characterization of dose-volume-effect relationships",
"BACKGROUND A non-r and omised phase II study suggested a therapeutic effect of hyperbaric oxygen ( HBO ) therapy on arm lymphoedema following adjuvant radiotherapy for early breast cancer , justifying further investigation in a r and omised trial . METHODS Fifty-eight patients with ≥ 15 % increase in arm volume after supraclavicular ± axillary radiotherapy ( axillary surgery in 52/58 patients ) were r and omised in a 2:1 ratio to HBO ( n=38 ) or to best st and ard care ( n=20 ) . The HBO group breathed 100 % oxygen at 2.4 atmospheres absolute for 100 min on 30 occasions over 6 weeks . Primary endpoint was ipsilateral limb volume expressed as a percentage of contralateral limb volume . Secondary endpoints included fractional removal rate of radioisotopic tracer from the arm , extracellular water content , patient self- assessment s and UK SF-36 Health Survey Question naire . FINDINGS Of 53/58 ( 91.4 % ) patients with baseline assessment s , 46 had 12-month assessment s ( 86.8 % ) . Median volume of ipsilateral limb ( relative to contralateral ) at baseline was 133.5 % ( IQR 126.0 - 152.3 % ) in the control group , and 135.5 % ( IQR 126.5 - 146.0 % ) in the treatment group . Twelve months after baseline the median ( IQR ) volume of the ipsilateral limb was 131.2 % ( IQR 122.7 - 151.5 % ) in the control group and 133.5 % ( IQR 122.3 - 144.9 % ) in the treatment group . Results for the secondary endpoints were similar between r and omised groups . INTERPRETATION No evidence has been found of a beneficial effect of HBO in the treatment of arm lymphoedema following primary surgery and adjuvant radiotherapy for early breast cancer",
"PURPOSE A multi-center prospect i ve r and omized trial was conducted to evaluate the efficacy and safety of Actovegin in the prevention and treatment of chemoradiotherapy-induced acute oral mucositis . METHODS AND MATERIAL S Between February 2006 and May 2007 , 156 evaluable patients with nasopharyngeal carcinoma were r and omized to Group 1 ( n=53 ) for prevention , Group 2 ( n=51 ) for treatment , and Group 3 ( n=52 ) for control . All patients received concomitant chemoradiotherapy ± induction chemotherapy . Radiation technique and dose were similar among 3 groups . Intravenous Actovegin of 30 ml daily ( 5 days/week ) was administrated from day 1 of the radiotherapy for Group 1 and from the onset of grade 2 mucositis for Group 2 , until the end of the radiotherapy . RESULTS The incidence of grade 3 mucositis was lower in Group 1 compared with Group 3 ( 26.4 % vs. 55.8 % , P=0.002 ) . Group 2 had a lower progression rate of mucositis from grade 2 to 3 compared with Group 3 ( 39.2 % vs. 60.4 % , P=0.035 ) . There was no difference in the onset time of grade 3 mucositis among 3 groups . Actovegin was well tolerated and no treatment-related adverse events were observed . CONCLUSIONS Actovegin is effective in the prevention and treatment of chemoradiotherapy-induced oral mucositis",
"BACKGROUND AND PURPOSE To report an early analysis of prospect i ve study exploring preoperative radiotherapy and local excision in rectal cancer . MATERIAL S AND METHODS Mucosa at tumour edges was tattooed . Patients with cT1 - 3N0 tumour were treated with either 5x5Gy+4Gy boost ( N=31 ) or chemoradiation ( 50.4Gy+5.4Gy boost , 1.8Gy per fraction+5-fluorouracyl and leucovorin ; N=13 ) . Thirteen patients from the short-course group were unfit for chemotherapy . The interval from radiation to full-thickness local excision was 6 weeks . The protocol called for conversion to a transabdominal surgery in case of ypT2 - 3 disease or positive margin . RESULTS The postoperative complications requiring hospitalization were recorded in 9 % of patients . The rate of pathological complete response was 41 % . The rate of patients requiring conversion was 34 % ; however , 18 % actually underwent conversion and the remaining 16 % refused or were unfit . During the 14 months of median follow-up , local recurrence was detected in 7 % of patients and all underwent salvage surgery . Of 19 patients in whom initially anterior resection was likely , 16 % had abdominoperineal resection performed for a conversion or as a rescue procedure . CONCLUSION Our study suggests that the short-course radiation prior to local excision is a treatment option for high-risk patients",
"PURPOSE Biliary tract lesions are comparatively rare neoplasms , with ambiguous indications for radiotherapy . The specific aim of this study was to report the clinical results of a single-institution biliary tract series treated with modern radiotherapeutic techniques , and detail results using both conventional and image-guided intensity-modulated radiation therapy ( IG-IMRT ) . METHODS AND MATERIAL S From 2001 to 2005 , 24 patients with primary adenocarcinoma of the biliary tract ( gallbladder and extrahepatic bile ducts ) were treated by IG-IMRT . To compare outcomes , data from a sequential series of 24 patients treated between 1995 and 2005 with conventional radiotherapy ( CRT ) techniques were collected as a comparator set . Demographic and treatment parameters were collected . Endpoints analyzed included treatment-related acute toxicity and survival . RESULTS Median estimated survival for all patients completing treatment was 13.9 months . A statistically significant higher mean dose was given to patients receiving IG-IMRT compared to CRT , 59 vs. 48Gy . IG-IMRT and CRT cohorts had a median survival of 17.6 and 9.0 months , respectively . Surgical resection was associated with improved survival . Two patients ( 4 % ) experienced an RTOG acute toxicity score>2 . The most commonly reported GI toxicities ( RTOG Grade 2 ) were nausea or diarrhea requiring oral medication , experienced by 46 % of patients . CONCLUSION This series presents the first clinical outcomes of biliary tract cancers treated with IG-IMRT . In comparison to a cohort of patients treated by conventional radiation techniques , IG-IMRT was feasible for biliary tract tumors , warranting further investigation in prospect i ve clinical trials",
"BACKGROUND AND PURPOSE Continuous , hyperfractionated , accelerated radiotherapy ( CHART ) has shown promise of improved tumour control and reduced late morbidity in pilot studies and has now been tested in a multicentre r and omised controlled clinical trial . MATERIAL AND METHODS Patients with squamous cell cancer in the main sites within the head and neck region with the general exception of early T1 N0 tumours were entered into the study by 11 centres . There was a 3:2 r and omisation to either CHART , where a dose of 54 Gy was given in 36 fractions over 12 days , or to conventional therapy where 66 Gy was given in 33 fractions over 6.5 weeks . A total of 918 patients were included over a 5 year period from March 1990 . RESULTS ACUTE MORBIDITY : Acute radiation mucositis was more severe with CHART , occurred earlier but settled sooner and was in nearly all cases healed by 8 weeks in both arms . Skin reactions were less severe and settled more quickly in the CHART treated patients . TUMOUR CONTROL AND SURVIVAL : Life table analyses of loco-regional control , primary tumour control , nodal control , disease-free interval , freedom from metastasis and survival showed no evidence of differences between the two arms . In exploratory subgroup analyses there was evidence of a greater response to CHART in younger patients ( P = 0.041 ) and poorly differentiated tumours appeared to fare better with conventional radiotherapy ( P = 0.030 ) . In the larynx there was evidence of a trend towards increasing benefit with more advanced T stage ( P = 0.002 ) . LATE TREATMENT RELATED MORBIDITY : Osteoradionecrosis occurred in 0.4 % of patients after CHART and 1.4 % of patients after conventional radiotherapy . The incidence of chondritis or cartilage necrosis was similar in both arms . Life table analysis showed evidence of reduced severity in a number of late morbidities in favour of CHART . These were most striking for skin telangiectasia , superficial and deep ulceration of the mucosa and laryngeal oedema . CONCLUSION Similar local turnout control was achieved by CHART as compared with conventional radiotherapy despite the reduction in total dose from 66 to 54 Gy supporting the importance of re population as a cause of radiation failure . The effects seen in advanced laryngeal cancer and those related to histological differentiation need further study . Reduced late morbidity is a factor which together with patient preference should be considered in the decision as to the programme of radiotherapy to employ in the curative treatment of head and neck cancer",
"BACKGROUND AND PURPOSE Hypoxia appears to be an important factor in predicting tumor relapse following radiation therapy . This study measured oxygenation prior to treatment in patients with cervix cancer using a polarographic oxygen electrode to determine if oxygenation was an important prognostic factor with regard to tumor control and survival . MATERIAL S AND METHODS Between May 1994 and June 1997 , 74 eligible patients with cervix cancer were entered into an ongoing prospect i ve study of tumor oxygenation prior to primary radiation therapy . All patients were evaluated with an Eppendorf oxygen electrode during examination under anesthesia . Oxygenation data are presented as the hypoxic proportion , defined as the percentage of pO2 readings of disease-free survival ( DFS ) rate was 69 % for patients with HP5 of 50 % ( log-rank P = 0.02 ) . Tumor size above and below the median of 5 cm was also significantly related to DFS ( P = 0.0003 ) and patients with bulky hypoxic tumors had a significantly lower DFS ( 12 % at 2 years ) than either bulky oxygenated or non-bulky oxygenated or hypoxic tumors ( 65 % , P = 0.0001 ) . CONCLUSIONS Hypoxia and tumor size are significant adverse prognostic factors in a univariate analysis of disease-free survival in patients with cervix cancer . A high risk group of patients with bulky hypoxic tumors have a significantly higher probability of relapse and death",
"The second part of the GYN GEC ESTRO working group recommendations is focused on 3D dose-volume parameters for brachytherapy of cervical carcinoma . Methods and parameters have been developed and vali date d from dosimetric , imaging and clinical experience from different institutions ( University of Vienna , IGR Paris , University of Leuven ) . Cumulative dose volume histograms ( DVH ) are recommended for evaluation of the complex dose heterogeneity . DVH parameters for GTV , HR CTV and IR CTV are the minimum dose delivered to 90 and 100 % of the respective volume : D90 , D100 . The volume , which is enclosed by 150 or 200 % of the prescribed dose ( V150 , V200 ) , is recommended for overall assessment of high dose volumes . V100 is recommended for quality assessment only within a given treatment schedule . For Organs at Risk ( OAR ) the minimum dose in the most irradiated tissue volume is recommended for reporting : 0.1 , 1 , and 2 cm3 ; optional 5 and 10 cm3 . Underlying assumptions are : full dose of external beam therapy in the volume of interest , identical location during fractionated brachytherapy , contiguous volumes and contouring of organ walls for > 2 cm3 . Dose values are reported as absorbed dose and also taking into account different dose rates . The linear-quadratic radiobiological model-equivalent dose (EQD2)-is applied for brachytherapy and is also used for calculating dose from external beam therapy . This formalism allows systematic assessment within one patient , one centre and comparison between different centres with analysis of dose volume relations for GTV , CTV , and OAR . Recommendations for the transition period from traditional to 3D image-based cervix cancer brachytherapy are formulated . Supplementary data ( available in the electronic version of this paper ) deals with aspects of 3D imaging , radiation physics , radiation biology , dose at reference points and dimensions and volumes for the GTV and CTV ( adding to [ Haie-Meder C , Pötter R , Van Limbergen E et al. Recommendations from Gynaecological ( GYN ) GEC ESTRO Working Group ( I ) : concepts and terms in 3D image-based 3D treatment planning in cervix cancer brachytherapy with emphasis on MRI assessment of GTV and CTV . Radiother Oncol 2005;74:235 - 245 ] ) . It is expected that the therapeutic ratio including target coverage and sparing of organs at risk can be significantly improved , if radiation dose is prescribed to a 3D image-based CTV taking into account dose volume constraints for OAR . However , prospect i ve use of these recommendations in the clinical context is warranted , to further explore and develop the potential of 3D image-based cervix cancer brachytherapy",
"PURPOSE This study investigated two fixed threshold methods to delineate the target volume using (18)FDG PET/CT before and during a course of radical radiotherapy in locally advanced squamous cell carcinoma of the head and neck . MATERIAL S AND METHODS Patients were enrolled into the study between March 2006 and May 2008 . (18)FDG PET/CT scans were carried out 72h prior to the start of radiotherapy and then at 10 , 44 and 66Gy . Functional volumes were delineated according to the SUV Cut Off ( SUVCO ) ( 2.5 , 3.0 , 3.5 , and 4.0bwg/ml ) and percentage of the SUVmax ( 30 % , 35 % , 40 % , 45 % , and 50 % ) thresholds . The background (18)FDG uptake and the SUVmax within the volumes were also assessed . RESULTS Primary and lymph node volumes for the eight patients significantly reduced with each increase in the delineation threshold ( for example 2.5 - 3.0bwg/ml SUVCO ) compared to the baseline threshold at each imaging point . There was a significant reduction in the volume ( p⩽0.0001 - 0.01 ) after 36Gy compared to the 0Gy by the SUVCO method . There was a negative correlation between the SUVmax within the primary and lymph node volumes and delivered radiation dose ( p⩽0.0001 - 0.011 ) but no difference in the SUV within the background reference region . The volumes delineated by the PTSUVmax method increased with the increase in the delivered radiation dose after 36Gy because the SUVmax within the region of interest used to define the edge of the volume was equal or less than the background (18)FDG uptake and the software was unable to effectively differentiate between tumour and background uptake . CONCLUSIONS The changes in the target volumes delineated by the SUVCO method were less susceptible to background (18)FDG uptake compared to those delineated by the PTSUVmax and may be more helpful in radiotherapy planning . The best method and threshold have still to be determined within institutions , both nationally and internationally",
"In the last two decades we have seen major advances in the way patients with rectal cancer are investigated and treated . Three key components , which have all been led by European investigators , are the well-documented improvements in pre-operative staging , improvements in surgical technique and histopathological assessment of the resected specimen [ 1 ] . Key studies have vali date d the importance of cross-sectional pelvic imaging , particularly phased array MRI and its ability to demonstrate the relationship of the macroscopic tumour to the surrounding well-defined anatomical plane of surgical excision . This development is closely linked with the ability of relatively simple histopathological techniques to assess and measure the distance of microscopic tumour to the circumferential resection margin ( CRM ) of the resected rectal cancer specimen [ 2,3 ] . The third key component is the recognition of the importance of the technique of rectal cancer surgery . The concept of ‘ ‘ mesorectal excision ” where meticulous dissection of the anatomical plane surrounding the mesorectal fat is of crucial importance and has been reported to result in significantly lower rates of local recurrence in specialist centres , population -based audit and within the framework of r and omised controlled trials [ 4 ] . In addition , European investigators have continued to test important questions in the framework of r and omised phase III trials with a specific focus on the role of adjuvant radiotherapy . In the last nine years at least seven European phase III trials evaluating the role of adjuvant radiotherapy in rectal cancer have been published . From these trials , we have an evidence base that demonstrates the efficacy of both short course pre-operative radiotherapy and pre-operative concurrent radiochemotherapy [ 5–11 ] . Despite a major increase in our knowledge we are aware of a wide variation in both opinion and practice within and between European ( and other ) countries . In the United States , the NIH consensus statement was published in 1990 and it had a major influence on North American practice . The EURECA project was proposed to identify the degree of consensus that could be achieved across a wide range of topics relating to the management of rectal cancer and of equal importance to identify areas where future research is a priority . The process anticipated a range of views amongst both experts and the health care professionals who",
"BACKGROUND AND PURPOSE A 5 week-hyperfractionated and accelerated radiotherapy regimen without reduction of the total dose was developed to fight tumour re population during treatment and tumour hypoxia . The purpose of the study was to try to improve loco-regional control in high risk head and neck carcinoma treated with curative radiotherapy . METHODS AND MATERIAL S From 1985 to 1995 , a r and omised controlled trial of the EORTC Cooperative Group of Radiotherapy ( EORTC 22851 ) compared the experimental regimen ( 72 Gy/45 fractions/5 weeks ) to st and ard fractionation and overall treatment time ( 70 Gy/35 fractions/7 weeks ) in T2 , T3 and T4 head and neck cancers ( hypopharynx excluded ) . The end-point criteria were local and loco-regional control , overall and disease-free survival , and acute and late toxicities . Five hundred twelve patients were accrued . RESULTS Patients in the AF ( accelerated fractionation ) arm did significantly better with regard to loco-regional control ( P = 0.02 ) result ing at 5 years in a 13 % gain ( 95 % CI 3 - 23 % gain ) in loco-regional control over the CF ( conventional fractionation ) arm . This improvement is of larger magnitude in patients with poorer prognosis ( N2 - 3 any T , T4 any N ) than in patients with more favourable stage . Multivariate analysis confirmed AF as an independent prognostic factor of good prognosis for loco-regional control ( P = 0.03 ) . Specific survival shows a trend ( P = 0.06 ) in favour of the AF arm . ACUTE AND LATE TOXICITIES : Acute and late toxicity were increased in the AF arm . Late severe functional irradiation damage occurred in 14 % of patients of the AF arm versus 4 % in the CF arm . Two cases of radiation-induced myelitis occurred after doses of 42 and 48 Gy to the spinal cord . CONCLUSIONS This trial shows that accelerated radiotherapy improves loco-regional control in head and neck squamous cell carcinomas . A less toxic scheme should , however , be investigated and documented before using accelerated radiotherapy as a st and ard regimen of curative radiotherapy for head and neck cancers",
"PURPOSE To prospect ively assess diagnostic performance of response assessment fluorodeoxyglucose positron emission tomography/computed tomography ( FDG-PET/CT ) in patients with HNSCC treated with high-precision definitive (chemo)radiation . METHODS Fifty-seven patients treated on a prospect i ve clinical trial having post-treatment response assessment FDG-PET/CT scans were included . Clinico-pathologic findings and follow-up information was considered as reference st and ard . RESULTS First response assessment FDG-PET/CT was done at a median of 9 weeks ( inter-quartile range 8 - 10 weeks ) from completion of treatment . The sensitivity , specificity , positive predictive value ( PPV ) , negative predictive value ( NPV ) , and accuracy of first response assessment FDG-PET/CT for identifying residual disease at primary site was 50 % , 91.8 % , 50 % , 91.8 % , and 86 % . The corresponding figures for the neck were 62.5 % , 98 % , 83.3 % , 94.1 % , and 93 % . With a median follow-up of 26 months ( range 7 - 45 months ) , the 3-year loco-regional control ( 83.9 % vs 58.3 % , p=0.001 ) and overall survival ( 68.8 % vs 58.3 % , p=0.063 ) was significantly better in patients with negative response assessment scans . CONCLUSION The overall diagnostic accuracy of response assessment FDG-PET/CT is good , but its sensitivity and PPV is somewhat low , particularly for primary site . A negative response assessment FDG-PET/CT scan is highly suggestive of absence of viable disease that could be used to guide decision-making",
"PURPOSE A r and omized phase II study was conducted to compare the toxicity and efficacy of combining short-term chemotherapy ( CT ) or protracted CT with radiotherapy ( RT ) for esophageal cancer . MATERIAL S AND METHODS Eligible patients were Two cycles of cisplatin 70 mg/m(2 ) for 1 day and 5FU 700 mg/m(2 ) for 5 days ( arm A ) or cisplatin 7 mg/m(2 ) for 10 days and 5FU 250 mg/m(2 ) for 14 days ( arm B ) were given with RT of 60Gy/30 fractions/7 weeks ( 1-week split ) . RESULTS Of 91 patients enrolled , 46 were r and omized to arm A and 45 to arm B. Two cycles of CT were given concurrently with RT for 89 % in arm A and for 71 % in arm B with significant difference ( P=.031 ) . The 2- and 5-year overall survival rates for arm A were 46 % and 35 % , while those for arm B were 44 % and 24 % , respectively , without significant difference . The 2- and 5-year progression-free survival rates for arm A were 30 % and 30 % , while those for arm B were 29 % and 12 % , respectively . CONCLUSIONS Protracted infusion CT with RT provides no advantage over st and ard short-term infusion CT with RT for esophageal cancer",
"PURPOSE To quantify the day-to-day target volume shape variation in rectal-cancer patients treated with preoperative 5x5Gy radiotherapy . MATERIAL S AND METHODS For 27 patients a prone position plan-CT ( pCT ) and five daily pre-treatment cone-beam-CT ( CBCT ) scans were acquired . A sub-region of the CTV ( MesoRect , anus up to the cranial end of the mesorectal-fascia ) was delineated on all scans . The MesoRect deformation was quantified by the distance between pCT- and CBCT-delineations and was stored in surface-maps . Finally , the influence of bladder and rectum filling on MesoRect deformation was evaluated . Data were analyzed for male and female patients separately . RESULTS A large range of systematic and r and om deformations , 1 - 7 mm ( 1SD ) , on different areas of the MesoRect were found . The maximum deformations were located at the upper-anterior-side of the MesoRect . For females the errors were up to 3 mm larger than for males . Small correlations , r(2)0.4 , were found with changes in bladder volume . Larger correlations , r(2)0.7 , were found for rectal volume in a distinctive area in the upper-half of the MesoRect . CONCLUSIONS Substantial and heterogeneous deformations of the MesoRect were found . Therefore different PTV margins in positions along the cranio-caudal axis , in the anterior-posterior direction . Margins should also be larger for female patients compared to male patients"
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41173958-06ff-11f0-808a-c43d1ab1c353
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